Notices. Notice

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BILLING CODE 4830-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0422] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Office of Management, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Office of Management (OM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to administer contracts. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov;* or to Arita Tillman, Acquisition Policy Division (049P1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or e-mail: *arita.tillman@va.gov.* Please refer to “OMB Control No. 2900-0422” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Arita Tillman at

(202)461-6859, FAX 202-273-6229. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-21), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA. With respect to the following collection of information,

(OM)invites comments on:

(1)Whether the proposed collection of information is necessary for the proper performance of (OM)'s functions, including whether the information will have practical utility;

(2)the accuracy of (OM)'s estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(VAAR)Clause 852.236-72, Performance of Work by the Contractor. b. Department of Veterans Affairs Acquisition Regulation

(VAAR)Alternate I to Clause 852.236-80, Subcontracts and Work Coordination. c. Department of Veterans Affairs Acquisition Regulation

(VAAR)Clause 852.236-82, Payments Under Fixed-Price Construction Contracts (without NAS), including Alternate 1. d. Department of Veterans Affairs Acquisition Regulation

(VAAR)Clause 852.236-83, Payments Under Fixed-Price Construction Contracts (with NAS), including Alternate 1. e. Department of Veterans Affairs Acquisition Regulation

(VAAR)Clause 852.236-84, Schedule of Work Progress. f. Department of Veterans Affairs Acquisition Regulation

(VAAR)Clause 852.236-88, Contract Changes, Supplements FAR Clause 52.243-4, Changes. *OMB Control Number:* 2900-0422. *Type of Review:* Extension of a currently approved collection. *Abstract:* The information contained Department of Veterans Acquisition Regulation

(VAAR)Clauses 852.236-72, Alternate I to 852.236-80, 852.236-82, 852.236-83, 852.236-84, and 852.236-88 is necessary for VA to administer construction contracts, and to carry out its responsibility to construct, maintain and repair real property for the Department. a. VAAR Clause 852.236-72, Performance of Work by the Contractor, requires contractors awarded a construction contract containing Federal Acquisition Regulation

(FAR)clause 52.236-1, to submit a statement designating the branch or branches of contract work to be performed by the contractor's own forces. The VAAR clause implements the FAR clause by requiring the contractor to provide information to the contracting officer on how the contractor intends to fulfill this contractual obligation. The contracting officer uses this information to ensure that the contractor complies with the contract requirements. b. Alternate I to Clause 852.236-80, Work Coordination, requires construction contractors, on contracts involving complex mechanical-electrical work, to furnish coordination drawings showing the manner in which utility lines will fit into available spaces and relate to each other and to the existing building elements. The information is used by the contracting officer and VA engineer assigned to the project to resolve any problems relating to the installation of utilities on construction contract. c. VAAR Clause 852.236-82, Payments Under Fixed-Price Construction Contracts (without NAS), requires construction contractors to submit a schedule of costs for work to be performed under the contract. If the contract includes guarantee period services, Alternate I requires contractor to submit information on the total and itemized costs of the guarantee period services and to submit a performance plan/program. The information is needed to allow the contracting officer to determine the correct amount to pay the contractor as work progresses and to properly proportion the amount paid for guarantee period services. d. VAAR Clause 852.236-83, Payments Under Fixed-Price Construction Contracts (with NAS), requires construction contractors to submit a schedule of costs for work to be performed under the contract. If the contract includes guarantee period services, Alternate I requires contractor to submit information on the total and itemized costs of the guarantee period services and to submit a performance plan/program. The information is needed to allow the contracting officer to determine the correct amount to pay the contractor as work progresses and to properly proportion the amount paid for guarantee period services. The difference between this clause and the one above 852.236-82 is that this clause requires the contractor to use a computerized Network Analysis System

(NAS)to prepare the cost estimate. e. VAAR Clause 852.236-84, Schedule of Work Progress, requires construction contractors, on contracts that do not require the use of a NAS, to submit a progress schedule. The information is used by the contracting officer to track the contractor's progress under the contract and to determine whether or not the contractor is making satisfactory progress. f. VAAR Clause 852.236-88, Contract Changes, Supplements FAR Clause 52.243-4, Changes. FAR Clause 52.243-4 authorizes the contracting officer to order changes to a construction contract but does not specifically require the contractor to submit cost proposals for those changes. VAAR Clause 852.236-88 requires contractors to submit cost proposal for changes ordered by the contracting officer or for changes proposed by the contractor. This information is needed to allow the contracting officer and the contractor to reach a mutually acceptable agreement on how much to pay the contractor for the proposed changes to the contract. It is also used by the contracting officer to determine whether or not to authorize the proposed changes or whether or not additional or alternate cost proposals for changes are needed. *Affected Public:* Business or other for-profit; Individuals and households; and Not-for-profit institutions. *Estimated Annual Burden:* a. VAAR Clause 852.236-72, Performance of Work by the Contractor—36 hours. b. VAAR Alternate I to Clause 852.236-80, Subcontracts and Work Coordination—1,190 hours. c. VAAR Clause 852.236-82, Payments Under Fixed-Price Construction Contracts (without NAS), including Alternate 1—1,397. d. VAAR Clause 852.236-83, Payments Under Fixed-Price Construction Contracts (with NAS), including Alternate 1—59 hours. e. VAAR Clause 852.236-84, Schedule of Work Progress—2,095 hours. f. VAAR Clause 852.236-88, Contract Changes, Supplements FAR Clause 52.243-4, Changes—807 hours. *Estimated Average Burden Per Respondent:* a. VAAR Clause 852.236-72, Performance of Work by the Contractor—1 hour. b. VAAR Alternate I to Clause 852.236-80, Subcontracts and Work Coordination—10 hours. c. VAAR Clause 852.236-82, Payments Under Fixed-Price Construction Contracts (without NAS), including Alternate 1—1 hour. d. VAAR Clause 852.236-83, Payments Under Fixed-Price Construction Contracts (with NAS), including Alternate 1—30 minutes. e. VAAR Clause 852.236-84, Schedule of Work Progress—1 hour. f. VAAR Clause 852.236-88, Contract Changes, Supplements FAR Clause 52.243-4, Changes—3 hours. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* a. VAAR Clause 852.236-72, Performance of Work by the Contractor—36. b. VAAR Alternate I to Clause 852.236-80, Subcontracts and Work Coordination—119. c. Department of Veterans Affairs Acquisition Regulation

(VAAR)Clause 852.236-82, Payments Under Fixed-Price Construction Contracts (without NAS), including Alternate 1—1,397. d. VAAR Clause 852.236-83, Payments Under Fixed-Price Construction Contracts (with NAS), including Alternate 1—119. e. VAAR Clause 852.236-84, Schedule of Work Progress—1,397. f. VAAR Clause 852.236-88, Contract Changes, Supplements FAR Clause 52.243-4, Changes—269. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23703 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0623] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Office of Management, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Office of Management (OM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to evaluate bidder's qualification and to support claims for price adjustment due to delay in construction caused by severe weather. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.regulations.gov;* or to Arita Tillman, Acquisition Policy Division (049P1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or e-mail: *arita.tillman@va.gov.* Please refer to “OMB Control No. 2900-0623” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Arita Tillman at

(202)461-6859, Fax 202-273-6229. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of OM's functions, including whether the information will have practical utility;

(2)the accuracy of OM's estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(VAAR)Clause 852.236.91. *OMB Control Number:* 2900-0623. *Type of Review:* Extension of a currently approved collection. *Abstract:* VAAR Clause 852.236.91 requires bidders to furnish information on previous experience, technical qualifications, financial resources, and facilities available to perform the work. The clause also requires contractors submitting a claim for price adjustment due to severe weather delay to provide climatologically data covering the period of the claim and covering the same period for the ten preceding years. VA uses the data collected to evaluate the bidder's qualification and responsibility, and to evaluate the contractor's claims for contract price adjustment due to weather-related delays. *Affected Public:* Business or other for-profit; Individuals and households; and Not-for-profit institutions. *Estimated Annual Burden:* 778 hours. a. *Qualifications Data:* 758 hours. b. *Weather Data:* 20 hours. *Estimated Average Burden Per Respondent:* a. *Qualifications Data:* 30 min. b. *Weather Data:* 1 hour. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 1,536. a. *Qualifications Data:* 1516. b. *Weather Data:* 20. Dated: November 27, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23707 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0180] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(PRA)of 1995 (44 U.S.C. 3501-21), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.regulations.gov;* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503

(202)395-7316. Please refer to “OMB Control No. 2900-0180” in any correspondence. FOR FURTHER INFORMATION OR A COPY OF THE SUBMISSION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, Fax

(202)273-0443 or e-mail: *denise.mclamb@mail.va.gov.* Please refer to “OMB Control No. 2900-0180.” SUPPLEMENTARY INFORMATION: *Title:* Compliance Report of Proprietary Institutions, VA Form 20-4274. *OMB Control Number:* 2900-0180. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA Form 20-4274 is used to determine whether proprietary educational institutions receiving Federal financial assistance comply with applicable civil rights statute and regulations. The collected information is used to identify areas that may indicate, statistically, disparate treatment of minority group members. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 25, 2007, at pages 54511-54512. *Affected Public:* Business or other for-profit, Federal Government. *Estimated Annual Burden:* 155 hours. *Estimated Average Burden Per Respondent:* 75 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 124. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23709 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0474] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(PRA)of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.regulations.gov* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503

(202)395-7316. Please refer to “OMB Control No. 2900-0474” in any correspondence. FOR FURTHER INFORMATION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, FAX

(202)273-0443 or e-mail *denise.mclamb@mail.va.gov.* Please refer to “OMB Control No. 2900-0474.” SUPPLEMENTARY INFORMATION: *Title:* Create Payment Request for the VA Funding Fee Payment System (VA FFPS) Computer Generated Funding Fee Receipt, VA Form 26-8986. *OMB Control Number:* 2900-0474. *Type of Review:* Extension of a currently approved collection. *Abstract:* Veterans obtaining a VA-guaranteed home loan must pay a funding fee to VA before the loan can be guaranteed. The only exceptions are loans made to veterans receiving VA compensation for service-connected disabilities, (or veterans whom, but for receipt of retirement pay, would be entitled to receive compensation) and unmarried surviving spouse of veterans who died in active military service or from service-connected disability regardless of whether the spouse has his or her own eligibility. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 25, 2007, at page 54512. *Affected Public:* Individuals or households and Business or other for profit. *Estimated Annual Burden:* 4,333 hours. *Estimated Average Burden Per Respondent:* 2 minutes. *Frequency of Response:* One-time. *Estimated Number of Respondents:* 130,000. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23711 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0624] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503

(202)395-7316. Please refer to “OMB Control No. 2900-0624” in any correspondence. FOR FURTHER INFORMATION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, FAX

(202)273-0443 or e-mail *denise.mclamb@mail.va.gov.* Please refer to “OMB Control No. 2900-0624.” SUPPLEMENTARY INFORMATION: *Title:* Obligation to Report Factors Affecting Entitlement (38 CFR 3.204(a)(1), 38 CFR 3.256(a) and 38 CFR 3.277(b)). *OMB Control Number:* 2900-0624. *Type of Review:* Extension of a currently approved collection. *Abstract:* Claimants who applied for or receives compensation, pension or dependency and indemnity compensation benefits must report changes in their entitlement factors. Individual factors such as income, marital status, and the beneficiary's number of dependents, may affect the amount of benefit that he or she receives or affect the right to receive such benefits. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 25, 2007, at page 54513. *Affected Public:* Individuals or households. *Estimated Annual Burden:* 31,017 hours. *Estimated Average Burden per Respondent:* 5 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 372,209. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23712 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0038] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503,

(202)395-7316. Please refer to “OMB Control No. 2900-0038” in any correspondence. FOR FURTHER INFORMATION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, FAX

(202)273-0443 or e-mail *denise.mclamb@mail.va.gov* . Please refer to “OMB Control No. 2900-0038.” SUPPLEMENTARY INFORMATION: *Title:* Information from Remarried Widow/er, VA Form 21-4103. *OMB Control Number:* 2900-0038. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA Form 21-4103 is used to collect data necessary to determine whether a child or children of a deceased veteran who served during a wartime period are eligible to receive death pension benefits when the surviving spouse's entitlement to death pension is permanently discontinued when he or she remarries. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 27, 2007, at pages 54981-54982. *Affected Public:* Individuals or households. *Estimated Annual Burden:* 334 hours. *Estimated Average Burden per Respondent:* 20 minutes. *Frequency of Response:* One-time. *Estimated Number of Respondents:* 1,000. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23714 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0130] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. DATE: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *www.Regulations.gov* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503

(202)395-7316. Please refer to “OMB Control No. 2900-0130” in any correspondence. FOR FURTHER INFORMATION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, FAX

(202)273-0443 or e-mail *denise.mclamb@mail.va.gov* . Please refer to “OMB Control No. 2900-0130.” SUPPLEMENTARY INFORMATION: *Title:* Status of Loan Account—Foreclosure or Other Liquidation, VA Form Letter 26-567. *OMB Control Number:* 2900-0130. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA Form Letter 26-567 is used to obtain information from holders regarding the status of a VA-guaranteed loan account at the time of foreclosure or other liquidation action. VA uses the information to specify the amount, if any, to be bid at the foreclosure sale. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 27, 2007, at pages 54979-54980. *Affected Public:* Business or other for profit. *Estimated Annual Burden:* 15,000 hours. *Estimated Average Burden Per Respondent:* 30 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 30,000. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23715 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0059] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503

(202)395-7316. Please refer to “OMB Control No. 2900-0059” in any correspondence. FOR FURTHER INFORMATION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, FAX

(202)273-0443 or e-mail *denise.mclamb@mail.va.gov* . Please refer to “OMB Control No. 2900-0059.” SUPPLEMENTARY INFORMATION: *Title:* Statement of Person Claiming to Have Stood in Relation of a Parent, VA Form 21-524. *OMB Control Number:* 2900-0059. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA Form 21-524 is used to gather information from claimants seeking service-connected death benefits as persons who stood in the relationship of the natural parent of a deceased veteran. The information is used to determine the claimant's eligibility for such benefits. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 27, 2007, at page 54980. *Affected Public:* Individuals or households. *Estimated Annual Burden:* 800 hours. *Estimated Average Burden Per Respondent:* 2 hours. *Frequency of Response:* One-time. *Estimated Number of Respondents:* 400. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23717 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0418] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Office of Management, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Office Management (OM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to determine whether or not a firm's plant being considered for an award has been inspected by another Federal agency and whether or not an award of a contract to the firm involves a conflict of interest. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov;* or to Arita Tillman, Acquisition Policy Division (049P1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or e-mail: *arita.tillman@va.gov.* Please refer to “OMB Control No. 2900-0418” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Arita Tillman at

(202)461-6859, Fax 202-273-6229. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of OM's functions, including whether the information will have practical utility;

(2)the accuracy of OM's estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(VAAR)Sections 809.106-1, 809.504(d), and Clause 852.209-70. *OMB Control Number:* 2900-0418. *Type of Review:* Extension of a currently approved. *Abstract:* a. VAAR section 809.106-1 requires VA to contact a firm being considered for a contract award for bakery, dairy, or ice cream products or for laundry or dry cleaning services whether or not the firm's facility has recently been inspected by another Federal agency and, if so, which agency. The information is used to determine whether a separate inspection of the facility should be conducted by VA prior to award contract. b. VAAR section 809.504(d) and Clause 852.209-70 requires VA to determine whether or not to award a contract to a firm that might involve or result in a conflict of interest. VA uses the information to determine whether additional contract terms and conditions are necessary to mitigate the conflict. *Affected Public:* Business or other for-profit; Individuals and households; and Not-for-profit institutions. *Estimated Annual Burden:* a. VAAR section 809.106-1-30 hours. b. VAAR section 809.504(d) and VAAR clause 852.209-7-500 hours. *Estimated Average Burden Per Respondent:* a. VAAR section 809.106-1-3 minutes. b. VAAR section 809.504(d) and Clause 852.209-7-30 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* a. VAAR section 809.106-1-600. b. VAAR section 809.504(d) and Clause 852.209-7-1,000. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23724 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0622] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Office of Management, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Office of Management (OM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to consider the use of domestic foreign construction material. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov;* or to Arita Tillman, Acquisition Policy Division (049P1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or e-mail: *arita.tillman@va.gov.* Please refer to “OMB Control No. 2900-0622” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Arita Tillman at

(202)461-6859, Fax 202-273-6229. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of OM's functions, including whether the information will have practical utility;

(2)the accuracy of OM's estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(VAAR)Clause 852.236-89, Buy American Act. *OMB Control Number:* 2900-0622. *Type of Review:* Extension of a currently approved collection. *Abstract:* The Buy American Act requires that only domestic construction material shall be used to perform domestic Federal contracts for construction, with certain exceptions. Despite the allowable exceptions, it is VA policy not to accept foreign construction material. VAAR clause 852.236-89 advises bidders of these provisions and requires bidders who choose to submit a bid that includes foreign construction material to identify and list the price of such material. VA uses the information to determine whether to accept or not accept a bid that includes foreign construction material. *Affected Public:* Business or other for-profit; Individuals and households; and Not-for-profit institutions. *Estimated Annual Burden:* 20 hours. *Estimated Average Burden Per Respondent:* 30 min. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 40. Dated: November 27, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23725 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0011] Agency Information Collection Activities Under OMB Review AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act

(OMB)for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 7, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov;* or to VA's OMB Desk Officer, OMB Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503

(202)395-7316. Please refer to “OMB Control No. 2900-0011” in any correspondence. FOR FURTHER INFORMATION CONTACT: Denise McLamb, Records Management Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420,

(202)461-7485, fax

(202)273-0443 or e-mail *denise.mclamb@mail.va.gov.* Please refer to “OMB Control No. 2900-2900-0011.” SUPPLEMENTARY INFORMATION: *Title:* Application for Reinstatement, VA Form 29-352 (Insurance Lapsed for more than 6 months) and VA Form 29-353 (Non-medical Comparative Health Statement). *OMB Control Number:* 2900-0011. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA Forms 29-352 and 29-353 are used to apply for reinstatement of insurance and/or Total Disability Income Provision that has lapsed for more than six months. VA uses the information collected to establish the applicant's eligibility for reinstatement. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The **Federal Register** Notice with a 60-day comment period soliciting comments on this collection of information was published on September 25, 2007 at pages 54512-54513. *Affected Public:* Individuals or households. *Estimated Annual Burden:* a. VA Form 29-352-500 hours. b. VA Form 29-353-375 hours. *Estimated Average Burden Per Respondent:* a. VA Form 29-352-20 minutes. b. VA Form 29-353-15 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* a. VA Form 29-352-1,500. b. VA Form 29-353-1,500. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23726 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0590] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Office of Management, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Office of Management (OM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to determine if offerors and contractors have adequate insurance coverage prior to contract awarded. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov;* or to Arita Tillman, Acquisition Policy Division (049P1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or e-mail: *arita.tillman@va.gov.* Please refer to “OMB Control No. 2900-0590” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Arita Tillman at

(202)461-6859, FAX 202-273-6229. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of OM's functions, including whether the information will have practical utility;

(2)the accuracy of OM's estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology. *Titles:* a. Veterans Affairs Acquisition Regulation Clauses 852.237-7, Indemnification and Medical Liability Insurance. b. Veterans Affairs Acquisition Regulation Clauses 852.237-71, Indemnification and Insurance. c. Veterans Affairs Acquisition Regulation Clauses 852.207-70, Report of Employment Under Commercial Activities. *OMB Control Number:* 2900-0590. *Type of Review:* Extension of a currently approved collection. *Abstract:* a. VA Acquisition Regulation Clauses 852.237-7 is used in solicitations and contracts for the acquisition of non-personal health care services. It requires the bidder/offeror prior to contract award to furnish evidence of insurability of the offeror and/or all healthcare providers who will perform under the contract. The information provided is used to ensure that VA will not be held liable for any negligent acts of the contractor or it's employees and that VA and VA beneficiaries are protected by adequate insurance coverage. b. Clause 852.237-71 is used in solicitations for vehicle or aircraft services. It requires the bidder/offeror prior to contract award to furnish evidence that the firm possesses the types and amounts of insurance required by the solicitation. The information is necessary to ensure that VA beneficiaries and the public are protected by adequate insurance coverage. c. Clause 852.207-70, is used in solicitations for commercial items and services where the work is currently being performed by VA employees and where those employees might be displaced as a result of an award to a commercial firm. The clause requires the contractor to report the names of the affected Federal employees offered employment opening and the names of employees who applied for but not offered employment and the reasons for withholding offers to those employees. The information collected is used by contracting officers to monitor and ensure compliance by the contractor under the requirements of Federal Acquisition Regulation clause 52.207-3, Right of First Refusal of Employment. *Affected Public:* Business or other for-profit; Individuals and households; Not-for-profit institutions, and State, Local or Tribal Government. *Estimated Annual Burden:* a. Veterans Affairs Acquisition Regulation Clauses 852.237-7, Indemnification and Medical Liability Insurance—750 hours. b. Veterans Affairs Acquisition Regulation Clauses 852.237-71, Indemnification and Insurance—250 hours. c. Veterans Affairs Acquisition Regulation Clauses 852.207-70, Report of Employment Under Commercial Activities—15 hours. *Estimated Average Burden Per Respondent:* 30 minutes. a. Veterans Affairs Acquisition Regulation Clauses 852.237-7, Indemnification and Medical Liability Insurance—30 minutes. b. Veterans Affairs Acquisition Regulation Clauses 852.237-71, Indemnification and Insurance—30 minutes. c. Veterans Affairs Acquisition Regulation Clauses 852.207-70, Report of Employment Under Commercial Activities—30 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 2,030. a. Veterans Affairs Acquisition Regulation Clauses 852.237-7, Indemnification and Medical Liability Insurance—1,500. b. Veterans Affairs Acquisition Regulation Clauses 852.237-71, Indemnification and Insurance—500. c. Veterans Affairs Acquisition Regulation Clauses 852.207-70, Report of Employment Under Commercial Activities—30. Dated: November 27, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23727 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0393] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Office of Management, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Office of Management (OM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to evaluate quotations received and to determine which quotation offers the best value in terms of price and other factors. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov;* or to Arita Tillman, Acquisition Policy Division (049P1), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; or e-mail: *arita.tillman@va.gov.* Please refer to “OMB Control No. 2900-0393” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Arita Tillman at

(202)461-6859, FAX 202-273-6229. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of OM's functions, including whether the information will have practical utility;

(2)the accuracy of OM's estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(VAAR)Part 813. *OMB Control Number:* 2900-0393. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA collects acquisition information from firms and individuals who wish to sell supplies, services, and construction or who wish to establish blanket purchase agreements

(BPA)or other contractually related agreements with VA. VA uses the information collected to determine to whom to award contracts or with whom to enter into BPAs or other contractually related agreements. *Affected Public:* Business or other for-profit, Individuals and households, Not-for-profit institutions, and State, Local or Tribal Government. *Estimated Annual Burden:* 20,845 hours. *Estimated Average Burden Per Respondent:* 1 hour. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 20,845. Dated: November 29, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23730 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0658] Proposed Information Collection Activity: Proposed Collection; Comment Request AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice. SUMMARY: The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act

(PRA)of 1995, Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments information needed to certify a lender's nominee as a VA Staff Appraisal Reviewer. DATES: Written comments and recommendations on the proposed collection of information should be received on or before February 4, 2008. ADDRESSES: Submit written comments on the collection of information through *http://www.Regulations.gov* or to Nancy J. Kessinger, Veterans Benefits Administration (20M35), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420 or e-mail to *nancy.kessinger@va.gov.* Please refer to “OMB Control No. 2900-0658” in any correspondence. During the comment period, comments may be viewed online through the Federal Docket Management System

(FDMS)at *http://www.Regulations.gov.* FOR FURTHER INFORMATION CONTACT: Nancy J. Kessinger at

(202)461-9769 or FAX

(202)275-5947. SUPPLEMENTARY INFORMATION: Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility;

(2)the accuracy of VBA's estimate of the burden of the proposed collection of information;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology. *Title:* Lender Appraisal Processing Program Certification, VA Form 26-0785. *OMB Control Number:* 2900-0658. *Type of Review:* Extension of a currently approved collection. *Abstract:* VA Form 26-0785 is completed by lenders to nominate employees for approval as approved Staff Appraisal Reviewer (SAR). Once approved, SAR's will have the authority to review real estate appraisals and to issue notices of values on behalf of VA. VA uses the information collected to perform oversight of work delegated to lenders responsible for making guaranteed VA-backed loans. *Affected Public:* Business or other for-profit. *Estimated Annual Burden:* 83 hours. *Estimated Average Burden per Respondent:* 5 minutes. *Frequency of Response:* On occasion. *Estimated Number of Respondents:* 1,000. Dated: November 30, 2007. By direction of the Secretary. Denise McLamb, Program Analyst, Records Management Service. [FR Doc. E7-23732 Filed 12-5-07; 8:45 am] BILLING CODE 8320-01-P 72 234 Thursday, December 6, 2007 Rules and Regulations Part II Department of Agriculture Food and Nutrition Service 7 CFR Part 246 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages; Interim Rule DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Part 246 [FNS-2006-0037] RIN 0584-AD77 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages AGENCY: Food and Nutrition Service, USDA. ACTION: Interim rule. SUMMARY: This interim rule revises regulations governing the WIC food packages to align the WIC food packages with the Dietary Guidelines for Americans

(DGA)1 and current infant feeding practice guidelines of the American Academy of Pediatrics, better promote and support the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. DATES: *Effective Date:* This rule is effective February 4, 2008. *Implementation Date:* State agencies must implement the provisions of this rule no later than August 5, 2009. *Comment Date:* To be considered, comments on this interim rule must be postmarked on or before February 1, 2010. ADDRESSES: The Food and Nutrition Service

(FNS)invites interested persons to submit comments on this interim rule. Comments may be submitted by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov,* select “Food and Nutrition Service,” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select FNS-2006-0037 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Mail:* Send comments to Patricia N. Daniels, Director, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 528, Alexandria, Virginia 22302,

(703)305-2746. Comments submitted in response to this interim rule will be included in the record and will be made available to the public. Please be advised that the substance of the comments and the identities of the individuals or entities submitting the comments will be subject to public disclosure. FNS will make the comments publicly available on the Internet via *http://www.regulations.gov.* Information regarding the interim rule will be available on the FNS Web site at *http://www.fns.usda.gov/wic.* A regulatory impact analysis has been prepared for this rule. It follows this regulation as an Appendix. FOR FURTHER INFORMATION CONTACT: Debra Whitford, Chief, Policy and Program Development Branch, Supplemental Food Programs Division, Supplemental Food Programs Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Room 528, Alexandria, Virginia 22302,

(703)305-2746, or *Debbie.Whitford@fns.usda.gov.* SUPPLEMENTARY INFORMATION: I. Overview This interim rule implements the first comprehensive revisions to the WIC food packages since 1980. These revised food packages were developed to better reflect current nutrition science and dietary recommendations than do current food packages, within the parameters of current program costs. II. Background The WIC food packages provide supplemental foods designed to address the nutritional needs of low-income pregnant, breastfeeding, non-breastfeeding postpartum women, infants and children up to five years of age who are at nutritional risk. WIC food packages and nutrition education are the chief means by which WIC affects the dietary quality and habits of participants. WIC is a unique nutrition assistance program in that it also serves as an adjunct to good health care during critical times of growth and development to prevent the occurrence of health problems and to improve the health status of Program participants. WIC was never intended to be a primary source of food, nor of general food assistance. Rather, WIC food benefits are scientifically-based and intended to address the supplemental nutritional needs of a specific population—low income pregnant, breastfeeding, non-breastfeeding postpartum women, infants and children up to five years of age who are at nutritional risk. In addition to WIC, the Food and Nutrition Service

(FNS)administers a variety of other complementary nutrition assistance programs that work together to provide a more complete diet to low-income persons. Low-income families can, and frequently do, receive benefits from more than one of these programs. The largest of these programs, the Food Stamp Program, provides general food assistance intended to increase the food buying power of low-income households. The ability of the WIC food packages to reinforce nutrition education messages provided to participants is critical to affecting the dietary quality and habits of infants, children and mothers served by WIC. The nutrition education provided by WIC enables participants to make informed decisions in choosing foods that, together with the supplemental foods contained in the WIC food packages, can meet their total dietary needs. The intent is to help participants continue healthful dietary practices after leaving the Program. Since the creation of the WIC Program in the 1970s, and the last major revision of the WIC food packages in the early 1980's, much has been learned about the nutritional needs of Americans, including WIC's target population of pregnant and postpartum women, infants, and preschool aged children. In recent years the ability of the WIC Program to address the supplemental nutritional needs of WIC participants through its food packages and nutrition education has received growing attention. Significant interest in updating the food packages based on new information about the needs of low-income, culturally diverse women, infants, and children has been voiced by WIC Program administrators, the medical and scientific communities, advocacy groups, and Congress. III. General Summary of Comments Received on the Proposed Rule To Revise the WIC Food Packages The Proposed Rule to revise regulations pertaining to the supplemental foods provided through the WIC Program was published in the **Federal Register** on August 7, 2006 (71 FR 44784), with a 90-day comment period. The proposed rule largely reflected recommendations made by the National Academies' Institute of Medicine

(IOM)in its Report “WIC Food Packages—Time for a Change,”

(2)with modifications found necessary by FNS to ensure cost neutrality. A total of 46,502 comment letters were received on the Proposed Rule; of those, 23,908 were form letters. A total of 38,257 letters were received from program participants; 18,080 of those were form letters. The remaining comment letters were submitted from a variety of sources, including WIC State and local agencies and Indian Tribal Organizations, the National WIC Association (NWA), professional organizations and associations, advocacy groups, healthcare professionals (including universities), members of Congress, the food industry, vendors, farmers, and private citizens. In general, the proposed changes to the WIC food packages garnered broad support from public commenters. A total of 21,042 commenters (8,293 of these form letters) made explicit statements regarding the merits of the proposed rule as a whole. Of those, 20,438 (8,292 of which were form letters) expressed support for the majority of the proposed revisions. A total of 604 commenters (1 of these a form letter) disagreed with the majority of the proposed rule provisions—these letters were primarily from participants who did not want to see any changes to the current WIC food packages. FNS considered all comments without regard to whether they were provided by a single commenter or repeated by many. Importance was given to the substance or content of the comment, rather than the number of times a comment was submitted. IV. Discussion of the Proposed Provisions The following is a discussion of the major provisions set forth in the proposed rule, a brief summary of the comments received that addressed these issues, and FNS' rationale for either modifying each section in the interim rule, or retaining its provisions as initially proposed. Provisions not addressed in the preamble to this interim rule did not receive significant or substantial public comments and are retained in this interim rule as proposed. This preamble articulates the basis and purpose behind significant changes from the August 7, 2006, proposal. The reasons supporting provisions of the proposed regulations were carefully examined in light of the comments to determine the continued applicability of the justifications. Unless otherwise stated, or unless inconsistent with the interim rule or this preamble, the rationales contained in the preamble to the proposed regulations should be regarded as a basis for the interim rule. Therefore, a thorough understanding of the rationales for the interim regulations may require reference to the preamble of the August 7, 2006 proposal (71 FR 44784). A. Definitions 1. *Participation.* FNS proposed to revise the definition for WIC “participation” to include the number of breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives the supplemental foods or food instruments. The definition means, therefore, that a partially breastfeeding woman who requests, after the sixth month postpartum, more than the maximum amount of formula allowed for a partially breastfed infant would no longer receive a food package but would continue to count as a WIC participant and receive other Program benefits and nutrition services (nutrition education, including breastfeeding promotion and support, and referrals to health and social services.) Thirty-two commenters (15 form letters) were opposed to not providing a food package to partially breastfeeding women who request, after the sixth month postpartum, more formula than the maximum. The IOM recommended that a partially breastfeeding woman who requests, after the sixth month postpartum, more than the maximum amount of formula for a partially breastfed infant, no longer be certified for the WIC Program. However, FNS determined that this approach is incongruous with the definition of breastfeeding in WIC regulations at 7 CFR 246.2—the practice of feeding a mother's breastmilk to her infant(s) on the average of at least once per day. In WIC, this definition is used to determine Program eligibility, and allows all breastfeeding women, regardless of feeding pattern, to participate in the WIC Program, be counted as a breastfeeding woman, and receive supplemental foods, breastfeeding promotion and support, and referrals to health care. The definition recognizes that any breastfeeding, even if only on an average of once a day, provides some immunological and nutritional benefits that would otherwise not be provided to an infant. Rather than adopt IOM's recommendation in its entirety, FNS proposed to revise the definition for WIC “participation” to include breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives supplemental food or food instruments. Counting these women, although they are not receiving a food package, is consistent with the current practice of counting the infants of exclusively breastfeeding women. Therefore, a partially breastfeeding woman who requests, after the sixth month postpartum, more than the maximum amount of formula allowed for a partially breastfed infant would no longer receive a food package but would continue to count as a WIC participant and receive other Program benefits (nutrition education, including breastfeeding promotion and support, and referrals to health and social services). This would serve to meet the intent of IOM's recommendations within the context of WIC regulations. As recommended by some commenters, FNS clarifies that breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives the supplemental foods or food instruments continue to be eligible to receive nutrition services, and breast pumps are a part of nutrition services. With this clarification, the definition of participation is retained in this interim rule as proposed at 7 CFR 246.2. 2. *WIC-eligible medical foods.* FNS proposed to revise the definition for “WIC-eligible medical foods” to clarify that medical foods are designed for children 12 months and older and adults and that WIC-eligible medical foods are not conventional foods, drugs, flavorings or enzymes. A few commenters disagreed with the proposed definition for WIC-eligible medical foods stating that the definition as proposed would exclude infants from receiving certain medical foods that are appropriate for them such as modular formulas that are not nutritionally complete but add specific nutrients such as protein, fat, and carbohydrate. FNS acknowledges that certain medical foods exist that are appropriate for use by infants and that medically fragile infants should be included as a participant category in the WIC-eligible medical food definition. Several other commenters believe that FNS should rely on Food and Drug Administration

(FDA)expertise for the definition of medical foods since FDA is the regulatory authority for medical foods. FNS acknowledges FDA's role in the regulation of medical foods. However, specific requirements for the safety or appropriate use of medical foods have not yet been established by FDA. FNS agrees with commenter concerns that the proposed definition for WIC-eligible medical foods excludes infants as a participant category. Therefore, the proposed definition for WIC-eligible medical foods is revised in this interim rule to include infants as a participant category. B. General Provisions That Affect All WIC Food Packages 1. Food Lists The proposed rule would have continued to require State agencies to identify brands and package sizes that are acceptable for use in their States from among those authorized and to provide to local agencies a list of acceptable foods and their maximum monthly allowances in accordance with WIC requirements. This provision is retained in this interim rule at 7 CFR 246.10(b)(2)(i). A conforming amendment in this interim rule at 7 CFR 246.4 clarifies that a copy of the food list must be included in the State Plan. 2. Nutrition Tailoring Current FNS policy allows both categorical and individual nutrition tailoring of WIC food packages. Categorical nutrition tailoring is the process of modifying the WIC food packages for participant groups or subgroups with similar supplemental nutrition needs, based on scientific nutrition rationale and State established policies. The proposed rule would have prohibited categorical nutrition tailoring, but continue to allow individual nutrition tailoring based on the Competent Professional Authority's assessment of a participant's supplemental nutrition needs. A total of 528 commenters (of these, 505 were form letters) agreed with the proposal to eliminate State authority to categorically tailor food packages, stating that the careful balance achieved by the IOM's recommendations to revise the WIC food packages should be maintained. In contrast, 187 commenters (of these, 151 were form letters) were opposed to the provision, stating that States need the flexibility to propose modifications to food packages that respond to rapid changes in food industry, science, demographics, and other factors. As discussed at length in the preamble to the proposed rule, the revised food packages have the potential to address current nutrient inadequacies and excesses; discrepancies between dietary intake and dietary guidance; and current and future health-related problems in WIC's target population. The IOM was also charged with considering the cultural needs of WIC participants and its recommendations for revisions to the WIC food packages, and the proposed rule, reflect those considerations. The IOM had the resources and capacity to conduct an independent, rigorous scientific review of the nutritional needs of WIC participants in each category prior to recommending the quantities and types of WIC foods to address those needs in its Report.

(2)Because the IOM based the revisions to the WIC food packages on current nutrition science, FNS proposed that State agencies would no longer be authorized to categorically tailor food packages. FNS believes that State agencies will best be able to meet the nutritional needs of each WIC participant through nutrition assessment and individual tailoring of the food package. Therefore, the provision to disallow State agency proposals to categorically tailor WIC food packages is retained in this interim rule at 7 CFR 246.10(c). FNS clarifies that, in addition to having the authority to individually tailor food packages, State agencies continue to have the authority to make adjustments to WIC foods for administrative convenience and to control costs. Such adjustments may involve packaging methods, container sizes, brands, types and physical forms of WIC foods. 3. Cultural Food Package Proposals A total of 174 commenters (of these, 149 were form letters) were opposed to FNS' proposal to no longer consider WIC State agency requests for cultural food substitutions. Commenters cited the need for State agencies to have the flexibility to keep pace with demographic changes in the WIC population. FNS believes that the increased variety and choice in the supplemental foods in this interim rule provide State agencies expanded flexibility in prescribing culturally appropriate packages for diverse groups. Section 203(c) of Public Law 108-265 amended Section 17(c)(2) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring the Secretary to conduct, as often as necessary, a scientific review of supplemental foods available under the program and to amend the foods, as needed, to reflect nutrition science, public health concerns, and cultural eating patterns. As such, future reviews of the WIC food packages by FNS will be used to determine the need for additional cultural accommodations. However, in response to requests by commenters to allow State agencies the flexibility to meet unanticipated cultural needs of participants, a new 7 CFR 246.10(i) has been added to this interim rule that allows State agencies to submit to FNS a plan for substitution of food(s) to allow for different cultural eating patterns. The criteria for submitting plans for substitutions for different cultural eating patterns and the criteria FNS will use to evaluate such plans are the same as those under current WIC regulations at 7 CFR 246.10(e). 4. Medical Documentation and Supervision Requirements Under the proposed rule, medical documentation would have been required for certain milk alternatives for children and women and for any supplemental foods authorized in proposed Food Package III. Under the proposed rule, medical documentation would continue to be required for any contract brand infant formula that does not meet the requirements of an infant formula as specified in Table 4 of 7 CFR 246.10(e)(12) of the proposed rule, any non-contract brand infant formula, any exempt infant formula, or any WIC-eligible medical food. Under current WIC regulations, the technical requirements for medical documentation include: • Brand name of the WIC formula prescribed; • Medical diagnosis warranting the WIC formula; • Length of time the prescribed WIC formula is medically required by the participant; and • Signature (or name, if the initial documentation was received by telephone) of the requesting health care provider. Under the proposed rule, additional technical requirements would have been added as follows: • Contact information for the participant's healthcare provider making the medical determination; • Date of medical determination; • Name of specific supplemental food(s) to be prescribed; • Amount prescribed per day of WIC formula and/or supplemental foods; • Qualifying condition that warrants the issuance of the specific supplemental food(s); and • Length of time the specific supplemental food(s) is medically required. A total of 2,107 comment letters (1,945 of these were form letters) opposed the proposed medical documentation, primarily the documentation for children to receive soy-based beverage. Commenter's stated that the medical documentation requirement for soy-based beverage for children would create barriers to services and undermine FNS' efforts to provide foods that meet the cultural needs of participants. A small number of comments received from WIC staff primarily at the local level expressed concern that requiring medical documentation for the additional supplemental foods allowed in proposed Food Package III and requiring a prescribed amount per day is burdensome to participants, the medical community and WIC agencies. FNS understands the potential administrative impact of requiring medical documentation for the provision of supplemental foods in Food Package III. However, these medical documentation requirements were proposed to ensure that the participant's healthcare provider, licensed in the State to write prescriptions, has determined that the supplemental foods are not medically contraindicated by the participant's qualifying condition. Participants that receive Food Package III are medically fragile and should be under the care of a healthcare professional for the purpose of close medical supervision essential for the participant's overall dietary management. Participants that receive Food Package III have qualifying medical conditions that preclude or restrict their use of conventional foods. Requiring medical documentation to include the additional supplemental foods allowed in proposed Food Package III and requiring an amount prescribed per day will ensure that the participant's health care provider is aware that WIC is providing supplemental foods that the health care provider has determined are not medically contraindicated by the participant's qualifying medical condition. Requiring the health care provider to designate an amount of WIC formula and the WIC supplemental foods allowed in the participant's diet will help the Certified Professional Authority

(CPA)in designing nutrition education and a food package prescription that is appropriate to the participant's medical needs. FNS acknowledges that some additional administrative tasks will occur because of medical documentation requirements for dairy alternatives. However, requiring medical documentation for soy-based beverage for children ensures that a child's health care provider is aware that the child may be at nutritional risk when milk is replaced by other foods. The DGA

(1)stress the importance of milk consumption in the development of bone mass for children. The IOM noted that while soy products may be an appropriate choice for children who cannot consume milk, soy should not be made available to satisfy participant preference in the absence of medical need. Therefore, the proposed provisions for medical documentation for certain milk alternatives for children and women and for any supplemental foods authorized in proposed Food Package III are retained in this interim rule at 7 CFR 246.10(d). Proposed provisions related to revised medical documentation requirements that are not addressed in this preamble did not receive significant or substantial public comments and are retained in this interim rule as proposed. 5. Organic Foods A number of commenters asked FNS to allow organic products within the authorized categories of foods in the WIC food packages. FNS points out that some organic forms of WIC-eligible foods meet the nutritional requirements set forth in current WIC regulations and are therefore authorized; this interim rule continues to authorize organic forms of foods that meet minimum nutrition requirements described in Table 4 of 7 CFR 246.10(e)(12). However, WIC State agencies are responsible for determining the brands and types of foods to authorize on their State WIC food lists. Some State agencies may allow organic foods on their foods lists, but this will vary by State. The decision may be influenced by a number of factors such as cost, product distribution within a State, and WIC participant acceptance. C. Supplemental Foods and Food Packages Note: In the interest of clarity, specific food package issues are discussed according to food item rather than food package and then the food package categories are discussed. The order of some of the topics in this section is modified from the proposed rule for the purposes of discussion. 1. Fruits and Vegetables in Food Packages III Through VII The addition of fruits and vegetables to the WIC food packages was the most welcomed provision of the proposed rule across all commenter categories. Of the total of 40,026 comment letters that addressed fruits and vegetables, 39,961 (22,935 of these form letters) were favorable. The majority of the few opposing comments were from participants who did not want to see any changes to the current WIC food packages. a. Maximum Monthly Allowances The IOM recommended that fruits and vegetables be provided at levels of $10 per month for women and $8 per month for children. To achieve cost neutrality, the proposed rule would have established the value of fruit and vegetable vouchers at levels of $8 per month for women and $6 per month for children. A total of 3,166 commenters (2,940 of these form letters) asked FNS to increase the cash-value vouchers to the level recommended by the IOM so that participants could receive one additional serving of fruits and vegetables per day. Commenters cited

(1)the important benefits of fruits and vegetables in decreasing high blood pressure, heart disease, obesity, and cancer;

(2)the generally low consumption of fruits and vegetables among WIC participants; and

(3)the role that WIC can play in helping participants meet the DGA

(1)for fruit and vegetable intake. Commenters urged FNS to seek additional funds to provide the cash-value vouchers at the level recommended by IOM. A total of 692 commenters (562 of these form letters) asked FNS to consider, at a minimum, increasing the cash-value fruit and vegetable voucher to $10 for fully breastfeeding women to further enhance the attractiveness of this package and provide an additional incentive for women to breastfeed. While FNS is in full agreement with the IOM and commenters regarding the benefits of fruits and vegetables for WIC participants, it is important that revisions to the WIC food packages be cost neutral to protect the program's ability to serve the greatest number of eligible women, infants, and children. For fruits and vegetables, the IOM's intent was to move WIC participants towards some amount of increased fruit and vegetable consumption and, at the same time, reinforce the role of the WIC food packages in nutrition education. The proposed $8 and $6 cash-value fruit and vegetable voucher fulfilled this intent while ensuring cost neutrality. Therefore, the provision will be retained in this interim rule as proposed for children and women in Food Packages III-VI in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11). However, FNS has considered the benefits of increasing the value of the vouchers for fully breastfeeding women and has determined that a $2 increase can be accomplished while maintaining cost neutrality. This provision is therefore revised in the interim rule in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11) to reflect a cash-value voucher of $10 for fully breastfeeding women in Food Packages III and VII. Thirty commenters (23 of which were form letters) preferred that a set amount of fruits and vegetables be authorized per month, e.g., 3 pounds for a child, in lieu of a cash-value voucher, for administrative ease and to control costs. FNS disagrees with this approach. A voucher, rather than a more narrowly defined fruit and vegetable option, offers flexibility, ensures participant access, and minimizes costs of compliance by administrative agencies and WIC-approved vendors. Allowing participants to choose a wide variety of fruits or vegetables is intended to increase consumption by accommodating individual and culturally-based preferences.

(1)*State agency responsibility to make available to participants at least two fruits and two vegetables from the category of fruits and vegetables in each authorized food package.* FNS proposed that State agencies be required to make available at least two fruits and two vegetables to participants in Food Packages III-VII. A total of 487 commenters (of which 418 were form letters) opposed the provision, believing that it undermines the IOM's recommendation to allow participants a wide variety of choices within the authorized fruit and vegetable options by authorizing State agencies to limit the number and variety of fruits and vegetables. FNS' intention with this proposed provision was to ensure participant choice among the fruit and vegetables authorized by the State agency by expanding current WIC regulations that require State agencies to make available at least one food from each group in each food package. As described in the preamble to the proposed rule, it was FNS' expectation that more than two varieties each of fruits and vegetables would be authorized by State agencies. Therefore, the proposed provision is clarified in the interim rule at 7 CFR 246.10(b)(2)(ii)(B) to ensure its original intent to require State agencies to allow participants to use their cash value vouchers to purchase any WIC-eligible fruits and vegetables from among those authorized in Table 4 of 7 CFR 246.10(e)(12). This allows participants a wide variety of choices within the authorized fruit and vegetable options without restriction, in keeping with IOM recommendations. Further, the proposed provision at 7 CFR 246.10(b)(1)(i) is revised in this interim rule to disallow further restrictions on eligible fruits and vegetables.

(2)*Minimum vendor stocking requirement.* Similarly, at 7 CFR 246.12(g)(3)(i), FNS proposed that WIC authorized vendors carry a minimum of two varieties of fruits and vegetables to ensure participant choice at the retail level, while acknowledging that certain smaller vendors may not be able to stock as wide a variety of fruits and vegetables as larger vendors. A total of 472 commenters (418 form letters) disagreed with this provision, stating that setting a minimum vendor stocking requirement of two fruits and vegetables undermines the IOM recommendation to allow participants a wide variety of choices. Of these commenters, 269 (221 form letters) stated that State agencies should be allowed to specify minimum stocking requirements. FNS points out that the proposed provision authorizes State agencies to establish different minimums for different vendor peer groups, thus allowing State agencies the flexibility to work with vendors to provide the maximum number and variety of fruits and vegetables that are locally accessible, culturally appropriate and affordable. However, it is required that all authorized vendors must stock at least two varieties of fruits, two varieties of vegetables, and one whole grain cereal authorized by the State agency. Therefore, the provision at 7 CFR 246.12(g)(3)(i) is retained in the interim rule as proposed; however, a technical oversight in the proposed rule has been corrected by clarifying that authorized vendors must stock at least two different varieties of fruits and two different varieties of vegetables. b. Inflation Adjustment FNS proposed an option to increase the value of the cash-value fruit and vegetable vouchers by a whole dollar increment. A total of 124 commenters (75 of which were form letters) asked that FNS commit to a yearly inflation adjustment. FNS agrees with commenter that it is important to maintain the value of the vouchers over time. Cash-value vouchers will be set at $6 for children and $8 for pregnant and partially breastfeeding and $10 for fully breastfeeding women in the year in which the food package revisions take effect. This interim rule adds a provision at 7 CFR 246.16(j) to adjust the maximum value of the vouchers in whole dollar increments using the Bureau of Labor Statistics' Consumer Price Index for Fresh Fruits and Vegetables. c. Minimal Restrictions on Authorized Fresh Fruits and Vegetables To improve the consumption of fresh fruits and vegetables and to appeal to participants of different cultural backgrounds, the proposed rule would have authorized a wide variety of choices within the authorized fruit and vegetable options. To ensure nutritional integrity and cost neutrality, some minimal restrictions were proposed, e.g., no herbs or spices, edible blossoms of flowers, fruit leathers and fruit roll-ups. The majority of commenters favored the provision to authorize a wide variety of fruits and vegetables; however, 9 commenters (1 of which was a form letter) stated the opinion that the fruit and vegetable selections should be limited to sources of priority nutrients. As stated in the Regulatory Impact Analysis that was published in the **Federal Register** as an appendix to the proposed rule, FNS considered alternatives to the proposed provision, including authorizing a more restrictive dark green and orange vegetable provision. This alternative was rejected because FNS believes that WIC food packages that reflect the IOM recommendations as closely as possible within the constraints of cost neutrality best reflect current scientific consensus on how to meet the supplemental dietary needs of WIC participants. The IOM chose not to emphasize the dark green and orange vegetable groups that tend to offer the highest concentrations of certain priority nutrients and instead recommended a fruit and vegetable option with few restrictions. Nutrition education offered by local WIC agencies will remain the primary method of encouraging participants to incorporate these high nutrient fruits and vegetables into their diets; under this interim rule participants remain largely free to choose the fruits and vegetables that they find most appealing. Thirteen commenters (2 of which were form letters) believe that FNS should simplify the proposed minimal restrictions to ease interpretation and implementation for participants, vendors, and staff. A total of 128 commenters (125 of which were form letters) asked FNS to allow State agencies flexibility to promote produce selections that come in standard packages with Universal Product Codes to minimize burden. As stated above, the nutrition education provided to participants is intended not only to encourage participant choice in the selection of fruits and vegetables, but also to provide information on shopping tips to obtain the maximum value of the voucher. FNS is aware that State agencies will need to provide training and technical assistance to participants and vendors in implementing the food package changes. State agencies generally update their food lists on a biennial basis which requires training for both participants and vendors. Recognizing the extensive changes that will be necessary as a result of this rule, FNS will assist State agencies on vendor training, participant education, and other implementation issues. FNS also encourages State agencies to work with their vendor associations as they develop their new State procedures, particularly in regard to the cash-value fruit/vegetable voucher. d. Disallowance of White Potatoes Under the proposed rule, white potatoes would have been excluded from authorization in the WIC food packages. A total of 324 commenters (of these 291 were form letters) opposed the restriction of white potatoes. Twenty-four commenters stated that white potatoes should be included in the WIC food packages because they are versatile, economical and contain key nutrients. Thirteen commenters (1 form letter) from WIC State and local agencies stated that the exclusion of white potatoes would be hard to administer. The restriction of white potatoes, as recommended by the IOM, is based on the amounts suggested in the DGA

(1)for consumption of starchy vegetables; food intake data indicating that consumption of starchy vegetables meets or exceeds these suggested amounts; and food intake data showing that white potatoes are the most widely used vegetable. Therefore, this provision is retained in the interim rule as proposed in Table 4 of 7 CFR 246.10(e)(12). e. Implementation of Fruit and Vegetable Options

(1)Small dollar denomination of fruit and vegetable food instruments. In the preamble to the proposed rule, FNS encouraged State agencies to issue small denomination, i.e., $2, cash-value fruit and vegetable food instruments. The small denominations were encouraged so the participant could obtain small amounts of fresh produce at various times during the month, lessening the chance of food spoilage and waste. A total of 200 commenters (of which 133 were form letters) disagreed with FNS' recommendation to provide the fruit and vegetable value in small denominations. The majority of those in opposition were WIC State and local agencies who stated that they should be allowed to determine, in partnership with vendors, the most cost effective method to provide the fruit and vegetable food instrument. FNS clarifies that although State agencies are encouraged to provide the cash-value food instrument in small denominations for the reasons cited above and in the proposed rule, State agencies will determine the dollar denomination that is most beneficial to participants and cost effective given the State agency's infrastructure and environment.

(2)Paying cash with the fruit/vegetable voucher. Nineteen commenters asked that participants be allowed to pay the difference when the purchase exceeds the value of the fruit/vegetable voucher. Under current rules at 7 CFR 246.12(c), State agencies must ensure that participants receive their authorized supplemental foods free of charge. Such a restriction is necessary with the “traditional” WIC food instrument which reflects a specific quantity of foods that a participant must receive. In contrast, the fruit/vegetable cash-value voucher reflects a maximum dollar allotment for the participant. Because it may be difficult to accurately estimate the exact purchase price of the fruit and vegetable selections, particularly when fresh and canned or frozen items are combined in one purchase, FNS concurs with commenters that participants should be allowed to pay the difference when the purchase of allowable fruits and vegetables exceeds the value of the fruit/vegetable voucher. This option would promote increased consumption of fruits and vegetables because participants would be more likely to utilize the full cash value, rather than partially redeem the voucher for fear of exceeding its cash value. The rule prohibits giving cash or credit to the participant for any unused portion of the fruit/vegetable voucher.

(3)Benefit delivery. While most of the food package changes will be administered via existing State benefit delivery systems, the cash-value fruit/vegetable voucher will require changes to WIC benefit delivery systems to accommodate a more open-ended benefit determined by a cash value rather than a fixed quantity of a specific food item. State agencies and vendors must modify operations and procedures to issue, transact, and process the redemption of a cash value benefit. As described in the proposed rule, options for benefit delivery include Electronic Benefit Transfer

(EBT)and farmers' markets.

(4)Farmers' markets. A total of 936 commenters (of which 170 were form letters) agreed with the provision to allow the fruit/vegetable cash-value voucher to be redeemed by farmers at farmers' markets. Eleven commenters disagreed with the provision. Many commenters suggested that FNS “Do no harm to the WIC Farmers' Market Nutrition Program (FMNP),” and that funding for the FMNP not be reduced or procedures established that would adversely affect its operation or effectiveness. FNS would like to clarify that the regulatory requirements for the FMNP are unchanged by this interim rule. Many commenters incorrectly believed that the proposal would have allowed FMNP coupons to be redeemed at authorized WIC vendors. This is not true; the proposal would have allowed the WIC fruit/vegetable cash-value voucher to be redeemed at farmers' markets. Of the commenters supporting the provision to allow farmers at farmers' markets to accept the fruit/vegetable cash-value voucher, clarification was requested on several issues—would State agencies be required to authorize farmers at farmers' markets if they do not currently administer the FMNP; can farmers at farmers' markets be treated as seasonal vendors and only be allowed to accept the fruit/vegetable voucher; can the State agency enter into one contract with the farmer that includes requirements for both WIC and the FMNP; and, can farmers' markets be excluded from the WIC vendor monitoring and audit requirements? In response to commenter questions, this interim rule will not require State agencies to authorize farmers to accept the WIC fruit/vegetable voucher. If a State agency chooses to authorize farmers at farmers' markets, it may modify its standard vendor agreement to address the unique circumstances of farmers' markets, as allowed by 7 CFR 246.12(h)(2). For example, the farmer's market agreement may only allow the farmer to accept the fruit/vegetable cash-value voucher. In addition, the State agency can choose to enter into one agreement with the farmer that includes the requirements for both the WIC and WIC Farmers' Market Nutrition Programs. Further, farmers would be excluded from the vendor cost containment requirements. The farmers may also be excluded from the WIC monitoring requirements provided that they are included in the sample of farmers upon which the FMNP monitoring requirement is drawn. A new 7 CFR 246.12(v) has been added that specifies the requirements regarding the authorization of farmers at farmers' markets. The rule also adds definitions for cash-value voucher and farmer (the same as that used in the FMNP), and modifies the food instrument requirements to identify the provisions that do not apply to the cash-value voucher. As a result of the addition of the definitions of farmer and cash-value voucher, we have made conforming amendments to the definitions of “compliance buy,” “employee fraud and abuse,” “participants,” “participant violations,” “proxy,” and “nutrition services and administration” to include these new terms as appropriate.

(5)Electronic Benefit Transfer (EBT). While the majority of State WIC agencies deliver benefits via paper checks or vouchers, 5 States are testing the feasibility of EBT and an additional State has adopted EBT statewide. Although it will take a number of years to implement WIC EBT fully in all States, the fruit and vegetable benefit may provide opportunities for alternative forms of benefit delivery and allow some States to move toward limited electronic benefit processing prior to the implementation of EBT for all WIC purchases. In an effort to explore the range of possibilities for using existing commercial infrastructure to administer the fruit and vegetable benefit including WIC EBT smartcard and online solutions, commercial debit cards, and other technologies, FNS commissioned a study by the State Information Technology Consortium (SITC). Although the report is not yet final, preliminary findings indicate that for redemption of the fruit/vegetable benefit, paper fruit and vegetable cash-value checks or vouchers appear to be the least costly and easiest to implement by State agencies and food vendors within a 12-month time period. The accountability for purchasing authorized fruits and vegetables remains the same as other food instruments—subject to training store clerks regarding eligible food items and State compliance monitoring. Debit type cards (EBT or credit/debit) with a magnetic strip offer potentially cost-effective solutions that leverage the widely available card payment infrastructure in the United States. Magnetic strip cards in volume can be purchased for less than 25 cents each. There are, for instance, many large and smaller food vendors that already accept credit card payments or accept EBT cards using a four digit Personal Identification Number (PIN). These vendors include most authorized WIC vendors. Focus groups with participants were favorable to this type of alternative because of lessened stigma while shopping and the ability to purchase foods incrementally rather than forfeiting some items with a paper instrument. Technical standards would need to be modified to enable card use only within authorized WIC vendor locations and there may be a need to define standards to facilitate retailer and/or EBT contractor changes to existing store equipment and software. The accountability for purchasing eligible foods only is similar to paper food instruments. WIC EBT solutions, on-line using magnetic-strip cards or off-line using smart cards, offer the greatest potential to ensure that only eligible fruits and vegetables are purchased with WIC cash-value vouchers, but it would be more costly for all stakeholders. These solutions would match each item scanned to a State list of authorized UPC's and/or Price Look-Up codes or PLUs. These solutions require additional investment by State agencies in cards, equipment, and maintenance of a much larger number of product Universal Product Codes and Price Look-Up

(PLUs)codes for fresh produce. The fresh produce industry has taken steps to institute greater standardization of PLUs; however, the seasonal and local produce suppliers do not always have means to use PLUs effectively. The draft SITC report suggests that pilot design and development will be necessary to identify cost effective solutions that can be widely adopted by State agencies and authorized vendors. 2. Peanut Butter and Legumes The proposed rule would have added 18 ounces of peanut butter in Food Package V to improve the intake of several nutrients in the diets of pregnant and breastfeeding women. The proposed rule would also add legumes (dried beans/peas or peanut butter) in Food Package VI for postpartum women. Canned beans were proposed as an optional substitute for dry beans in Food Packages III-VII. Of the 3,091 comment letters that addressed these provisions, 3,085 commenters (21 form letters)—a large majority of whom were participants—were in favor of the proposed changes. Six commenters asked that FNS eliminate peanut butter in the food packages for children because of concerns about peanut allergies. The IOM advised that children should avoid eating peanut butter from a spoon for safety reasons until age 3, but recommended that peanut butter continue to be offered in the WIC food packages for young children from 1 to 5 years of age. IOM has advised FNS that assessing for allergies and tailoring a young child's food package based on such assessment, as is current practice in WIC, is appropriate. Therefore, the proposed peanut butter and legume provisions are retained in this interim rule as proposed. 3. Milk and Milk Alternatives a. Maximum Monthly Milk Allowances The proposed rule would have decreased the maximum monthly allowances for milk in all food packages—for children and postpartum women, from 24 quarts to 16 quarts; for pregnant and partially breastfeeding women, from 28 to 22 quarts; and for fully breastfeeding women, from 28 quarts to 24 quarts of milk. Reducing the amount of milk provided through WIC is consistent with recommended limits on saturated fat, total fat, and cholesterol consumption put forth in the DGA,

(1)better aligns the amount of milk provided by WIC with the amounts recommended by the DGA

(1)and is consistent with the supplemental nature of the WIC Program. The majority of non-participant commenters were in favor of the proposed reductions in milk. A total of 2,088 non-participant commenters (1,874 of which were form letters) were supportive of the reductions, while 66 commenters were opposed. Commenters opposing the reductions cited the contribution of milk to intakes of priority nutrients for WIC participants, e.g., calcium, Vitamin A, and potassium. Seventeen commenters stated that the food package for postpartum women should be increased to the levels provided to pregnant and partially breastfeeding women. Six commenters urged FNS to maintain milk at current levels and increase funding for other proposed food package provisions. Comment letters from program participants reflected disappointment with the reductions in milk. A total of 1,831 comment letters were received from program participants who opposed the reductions; 225 participants wrote in favor of the proposed reductions. FNS believes that the IOM set forth a series of science-based recommendations that, taken together, balance the various supplemental nutritional needs of participants. According to the IOM, amounts of milk provided by the WIC food packages need not exceed amounts recommended by the DGA.

(1)The proposed dairy levels for children (2 cups/day) and pregnant and breastfeeding women (3 cups/day) provide at least 100 percent of the servings recommended by the DGA.

(1)The level for non-breastfeeding postpartum women is at least 2/3 of the amount set forth by the DGA.

(1)The proposed maximum monthly allowance of milk allows a more balanced food package to provide the various high priority nutrients within cost constraints. Therefore, the proposed maximum allowances for milk are retained in this interim rule in Table 2 of 7 CFR 246.10(e)(10) and Table 3 of 7 CFR 246.10(e)(11). b. Low-Fat Milk Under the proposed rule, only whole milk (not less than 3.25% milk fat) would have been authorized for children less than 2 years of age. For children two years of age and older and women, the proposed rule would have authorized only milk with no more than 2% milk fat to be consistent with current recommendations of the DGA 2005 to limit saturated fat and dietary cholesterol intake. A total of 3,058 commenters (2,663 of which were form letters) agreed with the provisions as written; 222 (10 of which were form letters) were opposed. One hundred seventy of those opposed were program participants. A total of 1,379 commenters (1,338 of which were form letters) stated that the fat content of milk for children and women should be reduced even further—to no more than 1% of milk fat. Seventy-eight commenters (23 of which were form letters) asked FNS to allow the CPA the authority to prescribe the type of milk (whole milk or low fat milk) to participants, regardless of age or category, if medically necessary for such reasons as failure to thrive, underweight or overweight. FNS' position is that participants who have medical conditions that lead to a diagnosis of failure to thrive will likely be issued Food Package III. Therefore, to address commenters' concerns, this interim rule will authorize whole milk for children 1 through 4 years of age and women in Food Package III, with medical documentation. As proposed, only milk with no more than 2% milk fat is authorized for children 2 years of age and older and women in Food Packages IV-VII. For these participants, nutrition education directed towards appropriate foods and food amounts should be provided for underweight or overweight participants. Nutrition education and individual tailoring of the food package within authorized parameters remain the most effective tools for WIC staff to use to help participants make appropriate choices based on their specific needs. c. Lactose Free Milk Under the proposed rule, as long as a milk conforms to the FDA standard of identity for milk as defined by 21 CFR Part 131 and meets WIC Federal requirements, it would be an authorized milk in Food Packages IV, V, VI, and VII. Although not specified in the proposed rule, authorized milks that conform to the FDA standard of identity include, but are not limited to, calcium-fortified, lactose-reduced and lactose-free, acidified, and ultra-high temperature

(UHT)milks. FNS clarifies that these products are authorized, and that lactose-free or lactose-reduced dairy products should be offered before non-dairy milk alternatives to those participants with lactose intolerance who cannot drink milk. FNS also clarifies that medical documentation is not required for participants to receive lactose-reduced and lactose-free milk. d. Authorized Substitutions for Milk (Cheese, Tofu, Soy-Based Beverage)

(1)Cheese. The proposed rule would have reduced the amount of cheese that may be substituted for milk to one pound per month for children and pregnant, postpartum and partially breastfeeding women, and two pounds for fully breastfeeding women. Reducing the amount of cheese that may be substituted for milk will reduce saturated fat and total fat intake by children age two and older and women consistent with the DGA

(1)recommendations. Amounts of cheese that exceed the maximum substitution amounts may be authorized with medical documentation in cases of lactose intolerance or other qualifying conditions. The majority of non-participant commenters were in favor of the proposed reduced cheese substitution amounts. A total of 754 non-participant commenters (of which 589 were form letters) were supportive of the reduced substitution amounts, while 53 commenters were opposed. A total of 917 comment letters were received from program participants who opposed the proposed cheese allowances; 119 participants wrote to express support for the proposed amounts. Commenters opposing the cheese substitution amounts stated that cheese is culturally acceptable to most populations, and provides nutrients in a convenient and familiar way. Fourteen commenters asked FNS to maintain cheese at its current substitution levels and emphasize or require reduced-fat cheese. Reducing the maximum amount of cheese lowers the amount of saturated fat, total fat, and cholesterol in the WIC food packages. Within the context of the proposed revisions to the WIC food packages as a whole, the reductions in the current levels of cheese ensure that FNS is able to provide a more balanced nutrient intake for WIC participants while maintaining cost neutrality. Therefore, the proposed substitution levels for cheese are retained in this interim rule.

(2)Soy-based beverage and tofu. To provide more flexibility for WIC State agencies and more variety and choice for WIC participants, the proposed rule would have authorized soy-based beverage to be substituted for milk for women in Food Packages V, VI and VII at the rate of 1 quart of soy-based beverage for 1 quart of milk up to the total maximum allowance of milk. The proposal also would have allowed calcium-set tofu to be substituted at the rate of 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk could be substituted in this manner in Food Packages V and VI, and a maximum of 6 quarts of milk may be substituted in Food Package VII. Under the proposed rule, soy-based beverage and tofu would not be allowed as substitutes for milk for children in Food Package IV without medical documentation. The qualifying conditions may include, but are not limited to, milk allergy, severe lactose maldigestion, and vegan diets. Amounts of tofu that exceed the maximum substitution amounts may be authorized for women, with medical documentation, in cases of lactose intolerance or other qualifying conditions. A total of 8,932 commenters (4,615 form letters) were supportive of adding soy-based beverage and tofu to the WIC food packages as milk substitutes; 368 commenters (148 form letters) were not supportive. Comments received on medical documentation requirements for soy-based beverage for children and FNS' rationale for retaining the provision in this interim rule as initially proposed are discussed in section IV.B.4. of this preamble. As stated in the preamble to the proposed rule, Section 102 of the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-265) requires that nondairy beverages offered as an alternative to fluid milk in the National School Lunch Program and School Breakfast Program must be nutritionally equivalent to fluid milk and meet nutritional standards set by the Secretary of Agriculture. FNS, therefore, proposed that authorized soy-based beverage provide, at a minimum, the following nutrients: Calcium 276 milligrams

(mg)per cup. Protein 8 grams per cup. Vitamin A 500 International Units

(IU)per cup. Vitamin D 100 IU per cup. Magnesium 24 mg per cup. Phosphorus 222 mg per cup. Potassium 349 mg per cup. Riboflavin 0.44 mg per cup. Vitamin B12 1.1 mcg per cup. A total of 340 commenters (255 form letters) were opposed to the proposed minimum nutrient standard, stating that fortification at these levels is not necessary, and that soy-based beverage meeting the proposed minimum nutrition standard are not available in the marketplace. FNS believes that it is imperative for WIC and the school nutrition programs to use the same standards for defining allowable soy-based beverage as alternatives to fluid milk. Therefore, the proposed minimum nutrient standard for soy-based beverage is retained in this interim rule. FNS is aware of at least one soy-based beverage in the marketplace that meets these requirements and anticipates that the marketplace will respond with additional products. To the extent that the marketplace doesn't respond with additional products, other options, such as tofu, are available for participants.

(3)Yogurt. The IOM recommended adding yogurt to the WIC food packages as a milk substitute for children and women. However, in order to maintain cost neutrality, the proposed rule did not include yogurt. Of the 758 commenters that addressed yogurt, 749 (617 form letters) disagreed with FNS' decision not to include yogurt. Commenters stated that yogurt provides priority nutrients, and is convenient, popular, and culturally acceptable to WIC participants. FNS agrees that yogurt would be a desirable dairy alternative to milk for WIC participants; however, the cost is simply prohibitive ($413.9 million over 5 years). In addition, FNS has determined that WIC participants will be able to get the calcium provided by yogurt through other foods authorized in these revised food packages. Lactose-free and lactose-reduced dairy products, for example, are readily available in both urban and rural areas for those WIC participants with lactose intolerance. Calcium-set tofu and soy-based beverages are available to accommodate cultural preferences. Also, as noted earlier, a new 7 CFR 246.10(i) has been added to this interim rule to allow State agencies the flexibility to meet unanticipated cultural needs of participants. It is important that revisions to the WIC food packages be cost neutral to protect the program's ability to serve the greatest number of eligible women, infants, and children. Therefore, FNS is unable to authorize yogurt in the WIC food packages in this interim final rule. However, FNS solicits comments from State agencies as they implement the provisions of this interim rule about the extent to which WIC participants would benefit from the addition of yogurt, and whether that addition would be achieved in a cost-effective way. In particular, we are interested in the impact of adding yogurt for women in Food Packages V-VII. FNS also solicits comments as to the feasibility of rebate agreements between yogurt manufacturers and individual States, so that yogurt could be provided to specific participant groups in the WIC program while maintaining cost-neutrality. State agencies are currently encouraged to explore the feasibility of cost containment systems, especially rebates, and to implement such a system where feasible for other WIC foods. In an effort to use their food grants more efficiently, 13 State agencies, which include 3 multi-State contracts, have rebate contracts for juice (frozen and shelf), infant juice and/or infant cereal. If FNS were to consider including yogurt as a WIC-eligible food through future rulemaking, FNS would be interested in the following types of information: • Which participant groups would most benefit from having yogurt included as part of their food package? • Would States be able to secure rebates sufficient enough to add yogurt for all or certain participant groups while maintaining cost-neutrality? Finally, and as noted earlier, Section 203(c) of Public Law 108-265 amended Section 17(c)(2) of the Child Nutrition Act of 1966, as amended (42 U.S.C. 1786), by requiring the Secretary to conduct, as often as necessary, a scientific review of supplemental foods available under the program and to amend the foods, as needed, to reflect nutrition science, public health concerns, and cultural eating patterns. As such, future reviews of the WIC food packages by FNS will be used to determine the need for yogurt. 4. Eggs Under the proposed rule, the maximum monthly allowance for fresh shell eggs would have been reduced from the current 2 or 2 1/2 to 1 dozen fresh shell eggs for children and women in Food Packages IV, V, and VI. For fully breastfeeding women in Food Package VII, the maximum monthly allowance was proposed at 2 dozen eggs. A total of 1,469 commenters (266 of which were form letters) addressed the proposed egg reduction provision. Of the 492 non-participant commenters, 406 were in favor of the proposed reductions. Those opposing stated that eggs provide important nutrients at relatively low cost. Of the 1,009 program participants who commented, 923 were opposed to the reduction in eggs. The proposed maximum monthly allowance of eggs is consistent with recommendations of the IOM

(3)and the DGA

(1)to reduce cholesterol. In addition, the IOM determined that protein is no longer a priority nutrient for the WIC population. Within the context of the proposed revisions to the WIC food packages as a whole, the reductions in the current levels of eggs ensures that FNS is able to provide a more balanced nutrient intake for WIC participants while maintaining cost neutrality. Therefore, the proposed maximum monthly allowances for eggs are retained in this interim rule. 5. Juice for Children and Adults The proposed rule would have reduced the maximum allowances of juice for women and children in Food Packages IV-VII. According to the IOM, deleting or reducing the quantity of juice in the WIC food packages helps allow for the inclusion of whole fruits and vegetables while containing food costs, and is consistent with recommendations of the DGA

(1)and the American Academy of Pediatrics (AAP). For children, the proposed maximum monthly allowance of juice would have been reduced from 288 fluid ounces to 128 fluid ounces. For pregnant and partially breastfeeding women, the proposed maximum monthly allowance of juice was reduced from 288 fluid ounces to 144 fluid ounces; for postpartum women from 192 fluid ounces to 96 fluid ounces; and for fully breastfeeding women, from 336 fluid ounces to 144 fluid ounces. A total of 2,256 commenters (846 form letters) addressed the proposed reductions in juice. Of these, 1,610 commenters (846 form letters) were supportive of the juice reductions. Eighty two of those commenters recommended that juice be eliminated entirely from the WIC food packages and replaced with fruits and vegetables. Of the 646 commenters that opposed the reduction in juice, 633 were program participants. Non-participant commenters who opposed the reductions cited the nutritional benefits of juice and stated that the proposed reductions were too drastic. Reducing the quantity of juice in the WIC food packages helps allow for the inclusion of whole fruits and vegetables while containing food costs. The reduction in the amount of juice provided for children to about 4 ounces per day is consistent with the AAP recommendation for that age group. The AAP also notes that juice does not provide any additional nutritional benefit beyond that of whole fruit. The reduced amount of juice for women is consistent with the recommendation of the DGA

(1)that whole fruits be used for a majority of the total daily amount of fruit. Additionally, 34 commenters (14 form letters) expressed concern that juice package sizes need to be considered to ensure the full nutritional benefit of juice is received by participants. Over the years, there have been many changes in package sizes for all WIC-eligible food categories, and FNS has struggled with how to manage these changes within WIC Program regulations that allow for a monthly maximum allowance of food that cannot be exceeded (except for the rounding option for infant formula and infant foods). It is not practical for FNS to be able to respond to all the variations in package sizing. Basing the maximum monthly allowance on package sizes would not guarantee that those package sizes will not change over time. Therefore, FNS is retaining the proposed maximum juice allowances for children and women in this interim rule. 6. Whole Grains and Breakfast Cereals To support the DGA

(1)recommendations to consume at least 3 servings per day of whole grains to reduce the risk of coronary heart disease and type 2 diabetes, to help with body weight maintenance, and to increase intake of dietary fiber, the proposed rule would have established a whole grain requirement for breakfast cereal in Food Packages III-VII and added whole wheat bread or other whole grain options for children and pregnant and breastfeeding women in Food Packages III, IV, V and VII. The addition of whole grains to the WIC food packages was popular across all commenter categories. A total of 17,165 comment letters (7,983 form letters) agreed with the whole grain provisions and 113 comment letters (5 form letters) disagreed with the provisions. While strongly supporting FNS' emphasis on whole grains, 876 commenters (764 form letters) expressed concern that the proposed nutritional requirement for whole grain breakfast cereal—using labeling requirements for making a health claim as a “whole grain food with moderate fat content” as defined by the Food and Drug Administration

(FDA)in its December 9, 2003, *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/~dms/flgrain2.html* —is too restrictive. Commenters stated that the proposed provision would eliminate corn and rice-based cereals that are necessary for participants with wheat allergies or strong preferences for corn and rice-based cereals, as well as severely limit the total variety and choice of WIC-eligible cereals. In addition, 77 commenters (21 form letters) also stated that whole grain foods are less palatable to young children, may not be preferred by certain cultures, and therefore may not be chosen by participants, potentially negating FNS' goal to help participants increase whole grain consumption. Additionally, commenters pointed to

(1)potential administrative difficulties in the identification of whole wheat bread and whole grain cereals by State agency staff when determining which products are WIC-eligible; and

(2)confusion by vendors and participants at the point of purchase due to lack of consistency in food labels that do not clearly identify foods as meeting the FDA standard of identity for whole wheat bread or the labeling requirement for making the health claim as “a whole grain with moderate fat content.” Commenters suggested several alternatives for determining a nutritional standard for whole grain cereals including the elimination of any requirement for whole grain, adoption of an 8-gram per serving standard, and exemption of certain cereals from the whole grain requirement. FNS finds merit in commenters' concerns that the proposed whole grain nutritional requirement for breakfast cereal would eliminate corn and rice-based cereals, as well as severely limit the variety and choice of WIC-eligible breakfast cereals; and that whole grain breakfast cereals may be less palatable to participants, especially children, and less preferred by certain cultures. WIC-eligible breakfast cereals are the major source of iron in the WIC food packages for children and women and research shows that participation in WIC has a positive impact on the iron status of its participants. The IOM pointed out that despite declines in the prevalence of iron-deficiency, this deficiency remains a nutrition-related health risk for children and women of reproductive age. Acceptability of eligible foods by participants is an important factor in the decision to authorize types and brands of foods for State food lists and therefore, in this interim rule, the provision at 7 CFR 246.10(e)(12) is revised to require that at least one half of the total number of breakfast cereals on the State's authorized food list meet the whole grain requirement using the FDA labeling requirements for making a health claim as a “whole grain food with moderate fat content.” Further, to assist in the identification of whole grain cereals for State agencies, vendors and participants, the interim rule adds the requirement that the primary ingredient by weight must be a whole grain. The remaining authorized breakfast cereals are required to meet only the iron and sugar requirements. State agencies may opt that all or more than half of the cereals on the State's authorized food list meet the whole grain requirement. However, in establishing minimum requirements for the variety and quantity of foods that a vendor must stock to be authorized, State agencies must require that at least one whole grain cereal be available. FNS believes that the revisions to the proposed whole grain provisions for cereals in this interim rule will continue to support the goals of the DGA

(1)for increasing whole grain consumption. State agencies are reminded that 7 CFR 246.10(b)(1)(i) allows the State to establish criteria in addition to the minimum Federal requirements for WIC supplemental foods, e.g., no artificial sweeteners. FNS also finds merit in commenters' concerns about administrative difficulties in the identification of whole wheat bread and whole grain products. It is important that WIC nutritional requirements be simple and accurate for State agencies to use when determining foods to authorize for State food lists and that authorized whole wheat and whole grain products make significant contributions of whole wheat or whole grain to the WIC food packages. Therefore, the proposed requirements for whole wheat bread —any bread that conforms to the FDA standard of identity for whole wheat bread as defined by 21 CFR 136.180 will be retained in this interim rule. However, to assist in the identification of whole wheat bread products for State agencies, vendors and participants, the interim rule adds the requirement that the primary ingredient by weight must be whole wheat. FNS also clarifies in this interim rule that whole wheat buns and rolls that meet the FDA standard of identity for whole wheat bread, and have whole wheat as their primary ingredient, are WIC-eligible. The proposed requirements for whole grain breads—any bread product that meets labeling requirements for making a health claim as a “whole grain food with moderate fat content” as defined by FDA in its December 9, 2003, *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/~dms/flgrain2.html* —will also be retained in this interim rule. However, the interim rule adds the requirement that the primary ingredient by weight must be whole grain. The revisions to the whole wheat and whole grain bread requirements will allow products that are 100% whole grain, or are primarily whole wheat or multi-grain, to be WIC-eligible as well as provide an easy way for participants and vendors to identify whole wheat and whole grain bread products by using the food label. The primary ingredient is easily identified on the food label since ingredients are listed in descending order of predominance by weight. To ensure that the whole grain options are consistent with the intent of the IOM recommendations, this interim rule also clarifies that the brown rice, bulgur (cracked wheat), oatmeal, and barley (whole-grain) are the whole unprocessed grain, and that soft corn and whole wheat tortillas must have the whole grain as the primary ingredient by weight according to the food label. A technical oversight in the proposed food package rule has been corrected in this interim rule by removing the requirement that authorized soft corn or whole wheat tortillas contain no added fats or oils. In the interim rule, State agencies will continue to be responsible for determining which types and brands of whole wheat bread and whole grain products and breakfast cereals to authorize on State food lists using the minimum requirements and specifications in Table 4 at 7 CFR 246.10(e)(12). FNS will provide information on label reading and marketplace availability to State agencies to assist in the identification of whole wheat and whole grain foods and on nutrition education that encourages increased consumption of whole grains. The assistance of industry is requested in notifying FNS of whole wheat and whole grain bread products, whole grain cereals, and whole grain options that may meet the newly established nutritional requirements. Information may be mailed or sent electronically to FNS at the addresses provided at the beginning of this preamble. Maximum Monthly Allowance The proposed rule would have established a maximum monthly allowance of 2 pounds of whole wheat bread or other whole grain options for children in Food Packages III and IV; and 1 pound of whole wheat bread or other whole grain options for women in Food Packages III, V and VII. The rule proposed a maximum monthly allowance of 36 ounces of breakfast cereal for children and women in Food Packages III-VII. While supporting the addition of whole wheat bread and other whole grain options to the WIC food packages, 95 comment letters (38 form letters) expressed concern that the package sizes of bread are not commonly available in either one- or two-pound loaves and that the participants would have difficulty purchasing the maximum monthly allowance for whole wheat bread. FNS has long recognized that package sizes of WIC-eligible foods vary among manufacturers and those manufacturers may change package sizes at any time. Over the years, there have been many changes in package sizes for all WIC-eligible food categories, and FNS has struggled with how to manage these changes within WIC Program regulations that allow for a monthly maximum allowance of food that cannot be exceeded (except for the rounding option for infant formula and infant foods). It is not practical for FNS to be able to respond to all the variations in package sizing. Basing the maximum monthly allowance on package sizes would not guarantee that those package sizes will not change over time and, therefore, the maximum monthly allowance for whole wheat bread and other whole grain options and breakfast cereal remains as proposed. 7. Canned Fish The proposed rule would have authorized 30 ounces of a variety of canned fish in Food Package VII for fully breastfeeding women. The following varieties of canned fish were proposed—light tuna, salmon, and sardines. In the proposed rule, FNS solicited input on additional canned fish to offer in Food Package VII. A total of 3,546 commenters (26 form letters) expressed support for the proposed canned fish provisions; 555 commenters opposed. Of the opposing comment letters received, 506 were variations of one form letter submitted as part of a letter writing campaign initiated by an advocacy organization concerned with the public's exposure to methylmercury. These and other opposing commenters believe that canned light tuna should be eliminated from the WIC food packages until more study is conducted on its mercury content. Two commenters (1 form letter) opposed the omission of albacore tuna from the list of authorized varieties of canned fish. The IOM recommended that a variety of canned fish that do not pose a mercury hazard be offered in Food Package VII. As identified by federal advisories of the Food and Drug Administration

(FDA)and the U.S. Environmental Protection Agency (EPA),

(4)canned light tuna, salmon, and sardines are among those fish that are lower in mercury. For ease of administration by State agencies, to accommodate participant preferences, and to minimize intake of mercury, this interim rule retains the proposed varieties of canned fish in Food Package VII for fully breastfeeding women. In response to commenters' requests, canned mackerel—N. Atlantic and Chub (Pacific)—also identified as lower in mercury, has been added in this interim rule as an authorized canned fish in Food Package VII. 8. Proposed Food Packages I and II for Infants The rule proposed the following changes in Food Packages I and II for infants: • Revise age specifications for assignment to infant food packages; • Delay introduction of complementary food to six months of age; • Establish 3 feeding options within each infant food package—fully breastfed, partially breastfed, or fully formula fed; • Revise maximum monthly infant formula allowances; • Add infant food fruits and vegetables in Food Package II; • Eliminate juice from both infant food packages; • Disallow provision of infant formula for breastfed infants during the first month after birth; • Disallow low iron infant formula; • Allow commercial infant food meat for fully breastfed infants in Food Package II; and • Reassign infants with a qualifying condition to proposed Food Package III—Participants With Qualifying Conditions—and authorize the issuance of exempt infant formulas only in Food Package III. The proposed revisions to Food Packages I and II for infants were designed to better promote and support the establishment of successful long-term breastfeeding among women who choose that feeding method, address differences in nutritional needs of breastfed and formula fed infants, address developmental needs of infants, bring the infant food packages in line with current infant feeding practice guidelines from the AAP, and serve all participants with certain medical conditions under one food package to facilitate efficient management of medically fragile participants. a. Food Package I for Infants Under Six Months Under current WIC regulations, a maximum formula allowance is specified for all infants assigned to Food Package I, regardless of infant feeding practice; WIC staff may tailor the amount of formula to reflect the individual needs of the infants. The proposed rule would have extended the age range of infants covered by Food Package I by two months, thereby delaying introduction of complementary foods previously offered in this food package (juice and cereal) until six months of age. In proposed Food Package I, fully formula fed infants four through five months of age would receive a slightly increased amount of infant formula to compensate in part for the decrease in nutrients and calories that results from the omission of juice and infant cereal. Also, to more actively support successful breastfeeding, the proposed rule would set a maximum formula amount for partially breastfed infants in Food Package I that is roughly half the maximum provided to fully formula fed infants. b. Food Package II for Infants Six Through Eleven Months Under the proposed rule, the amounts of formula and the amounts and type of infant foods would vary by infant feeding option. Infant food fruits and vegetables would be added to Food Package II, infant juice eliminated, and maximum formula allowances reduced for both partially breastfed and fully formula fed infants. The majority of commenters were supportive of the revisions to the infant food packages as proposed. The discussion that follows pertains to those provisions that received significant or substantial opposing comments, suggested alternatives, or requests for clarifications. Provisions related to the proposed food packages for infants that are not addressed in this preamble did not receive significant or substantial public comments and are therefore retained in this interim rule as proposed. c. Breastfeeding Provisions The proposed food packages for infants and women were designed to strengthen WIC's breastfeeding promotion efforts and provide additional incentives to assist mothers in making the decision to initiate and continue to breastfeed. The IOM's three-pronged approach to better promote and support breastfeeding through the WIC food packages was proposed. The approach focuses on the market value of the package for the mother/infant pair for the first year after birth, addresses differences in supplementary nutrition needs of breastfed and formula fed infants, and considers how to minimize early supplementation with infant formula through continued or increased efforts to promote and support the breastfeeding dyad. Because early supplementation may contribute to the short duration of breastfeeding, only two infant feeding options were recommended initially after delivery—either full breastfeeding or full infant formula-feeding. The IOM recommended this approach because physiology provides a strong basis for avoiding supplemental formula. The amount of milk a breastfeeding woman produces depends directly on how often and how long she nurses. Providing supplemental formula to a new breastfeeding mother may interfere with her milk production and success at continued breastfeeding. The differences in the proposed packages for the mother-infant pairs were based on differences in nutritional needs. For example, fully breastfeeding women require additional calories per day during the first six months postpartum as well as higher levels of most vitamins and minerals. Thus, the package for fully breastfeeding women provides the most food energy and nutrients, and the package for fully formula-feeding women provides the least. Similarly, starting at age six months, the proposed package for fully breastfed infants would have included commercial infant food meats to add a source of iron and zinc. These proposed food package changes, as recommended by the IOM, were intended to strengthen WIC's efforts to promote and support breastfeeding as the optimal infant feeding choice for WIC mothers. In general, commenters expressed support for the proposed breastfeeding provisions. Of the 1,057 commenters (774 form letters) that made statements regarding the breastfeeding provisions, 1,017 (753 form letters) were supportive of the provisions, stating that they add value and incentive for mothers to breastfeed and support WIC's efforts to promote breastfeeding as the optimal infant feeding choice. The largest number of opposing comments on the breastfeeding provisions focused on those related to the establishment of infant feeding options the first month after birth, as described below. Establishment of Infant Feeding Options—First Month After Birth To support the successful establishment of breastfeeding, the proposed rule would have established two infant feeding options for the first month after birth, either full breastfeeding or full formula-feeding. Under the proposed rule, infant formula would not be provided for fully or partially breastfeeding infants during the first month of life after birth. The IOM recommended this approach because providing supplemental formula to a new breastfeeding mother may interfere with her milk production and success at continued breastfeeding. A total of 862 commenters (540 form letters) addressed this provision. Of those, 195 commenters (102 form letters) agreed with the provision as written. A total of 667 commenters (438 form letters) were opposed. While agreeing with its premise—that early supplementation inhibits the establishment of successful breastfeeding in the critical early weeks of an infants life—opposing commenters expressed concern that some WIC State and local agencies may not be prepared to provide support services (peer counselors, breast pumps, consultation with lactation experts) to the extent necessary to make this provision work for every mother. As a result, a mother who feels less than confident about her ability to breastfeed may choose to either

(1)categorize her infant as fully formula fed, thus receiving more formula than is necessary for the breastfeeding infant and further compromising the establishment of successful breastfeeding, or

(2)not breastfeed at all. Other commenters pointed to legitimate medical reasons that a breastfeeding mother/infant dyad may have which result in the need for supplemental formula in the early postpartum period, such as infants with metabolic disorders. Commenters urged FNS to consider allowing State agencies the option to provide a small amount of infant formula during the first month in limited situations. FNS finds the arguments put forth by commenters compelling. Therefore, the provisions at 7 CFR 246.10(e)(1)(ii)(A) and in Table 1 of 7 CFR 246.10(e)(9) are revised as follows. Three infant feeding options will be authorized in the first month after birth—either

(1)fully formula feeding;

(2)fully breastfeeding; or

(3)partially breastfeeding. As proposed, no supplemental formula will be provided for fully breastfeeding infants. The third infant feeding option—partially breastfeeding—will be offered to the infant who is breastfed but also receives not more than 104 reconstituted fluid ounces of formula from the WIC program. Food Package V will be provided to mothers of these partially breastfeeding infants. Partially breastfed infants ages 0 to 1 month may receive the equivalent of not more than 104 fluid ounces of reconstituted infant formula. This will allow State agencies to issue one can of powder infant formula commonly used in WIC, and is responsive to commenters' requests to make a small amount of infant formula available for partially breastfeeding infants in the first month. Powder infant formula is recommended until the partially breastfed infant reaches four months of age due to its longer shelf life and to minimize waste. The CPA is expected to individually tailor the amount based on the carefully assessed needs of the individual breastfeeding infant. This means that mothers of partially breastfed infants should not “automatically” be provided a can of formula in the first month of life. If, after a careful assessment, the CPA determines that some formula is appropriate for the infant in the first month, the mother should be advised on the appropriate amount of that one can of formula to feed the infant. The goal is to provide as minimal amount of supplemental formula as is needed, while offering counseling and support, in order to help the mother establish a successful milk supply. FNS is aware that adequate breastfeeding support for mothers is important for the success of both the partially and fully breastfeeding options in the first month after birth. FNS is committed to strengthening WIC's efforts to promote and support breastfeeding, through the provision of peer counseling funding to State agencies and other means. Judicious use of NSA funds by State agencies directed toward research-based support known to be effective—i.e., peer counseling, consultation with lactation experts—will further enhance the ability of State and local agencies to assist mothers in establishing and continuing successful breastfeeding in the critical weeks after birth and beyond. FNS' view is that the provision of a small amount of formula for certain infants in the first month of life is a temporary option that State agencies may invoke to assist breastfeeding mothers who may otherwise choose to fully formula feed. FNS expects that the proportion of participants offered the partially breastfeeding option in the first month will decrease over time as State agencies strengthen their breastfeeding support infrastructure. d. Maximum Monthly Allowances of Infant Formula Under the proposed rule, the maximum monthly allowance of infant formula would be revised from current levels to reflect the proposed feeding options (fully formula feeding, partially breastfeeding, and fully breastfeeding), physical form of infant formula provided (liquid concentrate, powder, or ready-to-feed), and the age of the infant. A total of 574 commenters (143 form letters) addressed the maximum monthly allowances of infant formula. Two hundred forty four commenters were opposed to changes in the maximum monthly allowances; of these, 148 were program participants. The majority of comments centered on two specific issues:

(1)The variation in amounts of formula provided during the different age specifications; and

(2)a decrease in amount of formula available, especially for the 6-12 month old infant. Non-participant commenters in opposition to revising formula allowances stated that reducing formula will result in supplementation with whole milk or inappropriate liquids. Some non-participant commenters stated that formula amounts should stay the same as in current regulations and the CPA should tailor the packages as appropriate for the needs of individual infants. Participant commenters expressed concern that formula is expensive and if WIC reduces the amount provided it will increase their out-of-pocket expenses to purchase the additional formula. The proposed maximum formula allowances for infants were determined based on a scientific review of the calorie and nutrient needs of infants at different ages. The proposed amounts of infant formula for partially breastfeeding infants in Food Packages I and II are designed to enhance the promotion and support of breastfeeding. The provision is part of the IOM's comprehensive approach resulting from thorough consideration of scientific research and public comments on how to promote and support breastfeeding. The maximum amount for partially breastfed infants provides approximately half the amount provided to fully formula fed infants—to provide about half of the infant's nutritional needs to encourage the mother to breastfeed enough to provide at least half of the infant's nutritional needs. This approach is preferable to current tailoring because it establishes a standard procedure that promotes breastfeeding as the optimal way to feed infants across WIC programs. The addition of infant foods, along with the proposed amount of formula for infants in Food Package II, provides close to recommended amounts of nutrients, introduces more variety into the infant's diet and encourages healthy dietary patterns. FNS believes that the nutrition education and anticipatory guidance on infant feeding provided by WIC local agencies will enable participants and caregivers to make informed choices about appropriate liquids for infants. Other commenters asked for clarification on the maximum monthly allowances of infant formula per physical form and suggested that the maximum monthly allowance for infant formula be the same for all physical forms. The IOM recommended a maximum monthly allowance of liquid concentrate but stated that powder or ready-to-feed formula

(RTF)may be substituted for liquid concentrate at rates that provide the approximate number of fluid ounces as the liquid concentrate. The IOM recommended rounding to whole cans to approximate the target amount. FNS recognizes that powder infant formula is an increasingly popular physical form with WIC agencies and participants. In determining the amount of powder formula to authorize, FNS considered the cans sizes commonly used in WIC, their reconstituted yields, and the range of dry powder ounces recommended by the IOM. The maximum monthly allowance of powder infant formula provides at least the number of fluid ounces as the same reconstituted liquid concentrate for the 3 major milk-based infant formulas manufactured that State agencies issue, thereby ensuring a minimum level of nutrition for infants regardless of physical form. As described in section C.8.c. of this preamble, partially breastfed infants ages 0 to 1 month may receive the equivalent of not more than 104 fluid ounces of reconstituted infant formula. This will allow State agencies to issue one can of powder infant formula commonly used in WIC, and is responsive to commenters' requests to make a small amount of infant formula available for partially breastfeeding infants in the first month. The maximum allowances of infant formula for infants 1 month and older in Food Package I and II are retained in this interim rule as proposed. Exhibit A.—Maximum Monthly Allowances for Food Package I for Infants Ages Birth to 6 Months, by Feeding Option WIC food Fully breastfed infants 0 through 5 months Partially breastfed infants Birth to one month 1 through 3 months 4 through 5 months Fully formula fed infants 0 through 3 months 4 through 5 months Infant Formula NA 104 fl oz reconstituted powder 364 fl oz reconstituted liquid concentrate * 442 fl oz reconstituted liquid concentrate 806 fl oz reconstituted liquid concentrate 884 fl oz reconstituted liquid concentrate. NA= not applicable. * The maximum monthly allowance is specified in the liquid concentrate form; however, powder and RTF are allowable substitutes and the powder form is recommended for partially breastfed infants, ages 0 through 3 months of age. Two technical oversights in the proposed food package rule have been corrected in this interim rule by adjusting the maximum monthly allowance of RTF formula in Food Package I.A. from 800 fluid ounces to 832 fluid ounces, and in Food Package II.A. from 364 fluid ounces to 384 fluid ounces. e. Elimination of Juice for Infants and Addition of Infant Foods in Food Package II A total of 629 commenters (69 form letters) addressed the elimination of juice from the infant food packages. The majority of commenters were in agreement with the provision to eliminate juice from the infant food packages, stating that juice is not nutritionally valuable or necessary for infants. A total of 242 commenters were opposed; 228 of those opposed were program participants. Twelve non-participant commenters stated that the elimination of juice may lead to substitution of lower-cost sweetened beverages. The IOM specifically recommended that infant food fruits and vegetables replace juice for infants 6 through 12 months of age. An important part of the nutrition education provided by WIC staff to parents and caregivers of infant participants' is information on the timing and types of complementary foods appropriate for infants. The addition of jarred infant foods (fruits, vegetables, meat) to Food Package II was well received by commenters. Of the 5,953 commenters that addressed infant foods, 5,887 commenters (of these, 131 were form letters) expressed support for the addition of infant foods. Those that opposed asked that fresh, canned, or frozen fruits and vegetables be allowed in Food Package II instead of, or as an option, to jarred infant foods. Some of these commenters believe that jarred infant foods are environmentally wasteful and costly. Others stated that the provision of jarred foods undermines nutrition education messages about home prepared foods for infants. Some commenters stated that providing a cash value voucher for fruits and vegetables for infants 9-12 months of age may be more developmentally appropriate for this age group. The IOM specifically recommended “commercial baby food fruits and vegetables and fresh bananas” for

(1)early introduction to new flavors and textures over time;

(2)nutrient content;

(3)availability in developmentally appropriate textures; and

(4)food safety. Further, the provision of commercial baby food fruits and vegetables helps ensure that these items are consumed by infants and not other participants, an important consideration since the amount of infant formula in Food Package II is reduced from current levels and replaced with complementary infant foods. Therefore, the proposed provisions about jarred infant foods in Food Package II are retained in this interim rule. FNS does not believe that the provision of jarred infant foods is incompatible with the nutrition education provided by WIC staff related to appropriate food choices and home preparation of foods for infants since the amount of infant foods provided by WIC is supplemental to an infant's entire needs.

(1)Authorized infant meat. A technical oversight in the proposed rule has been corrected in this interim rule by clarifying the minimum requirements and specifications for authorized infant meat as—any variety of commercial infant food meat or poultry, as a single major ingredient, with added broth or gravy. Added sugars or salt (i.e. sodium) are not allowed. Texture may range from pureed through diced.

(2)Infant cereal. As proposed, the maximum quantity of infant cereal was not changed from current WIC regulations. Thirteen commenters believe that the amount of infant cereal should be reduced. These commenters stated that in their experience infants did not eat the volume of infant cereal provided by WIC. The IOM recommended that the amount of iron-fortified infant cereal for infants six months and older remain at 24 ounces. Therefore, the proposed maximum amount of infant cereal is retained in this interim rule. f. Rounding Up of Infant Foods Public Law 108-265, the Child Nutrition and WIC Reauthorization Act of 2004, enacted on June 30, 2004, contains a provision that allows a State agency to round up to the next whole can of infant formula to allow all participants to receive the full-authorized nutritional benefit specified by regulation. This provision only applies to infant formula (not exempt infant formula or WIC-eligible medical foods) issued as a result from a solicitation bid on or after October 1, 2004. The proposed rule described the “full-authorized nutritional benefit” as well as a methodology that State agencies would be required to use if choosing to implement the option to round up. Consistent with the authority allowing State agencies to round up infant formula, FNS proposed rounding up of infant foods (infant cereal, fruit, vegetables and meat) to provide administrative flexibility to State agencies to ensure that infants would receive the full nutritional benefit recommended by the IOM. Of the 139 comments received on this issue, 129 commenters (66 form letters) disagreed with the proposed methodology for rounding up. Seventy-seven commenters (40 form letters) stated that the proposed methodology was confusing and time-consuming to calculate. Twenty-four commenters (21 form letters) urged FNS to allow State agencies to determine their own methodology for rounding up. FNS is sensitive to commenters' concerns and will further assist State agencies that choose to implement the option to round up. FNS believes, however, that a standard methodology for rounding up, uniformly applied across State agencies, is imperative. Therefore, the rounding up provisions are retained in this interim rule as proposed, except that this interim rule clarifies that the full nutritional benefit for infant formula is provided as a minimum on average during the timeframe that the food package is provided. This means that when the rounding methodology is applied, in some months participants will receive less than the full nutritional benefit amount, and other months will receive more; however, on average, participants will receive the full nutritional benefit. The full nutritional benefit is defined as the maximum monthly allowance of reconstituted fluid ounces of liquid concentrate infant formula for the food package category and feeding option, e.g. partially breastfed infants 4 through 5 months of age. 9. Revisions in Food Package III and Their Effect on Food Packages I and II Under proposed Food Package III, infants with qualifying conditions would be added and other supplemental foods would be authorized. The revisions were intended to provide flexibility in accommodating the wide range of nutritional needs of participants served by this food package, and facilitate the efficient management and tracking of the costs of providing supplemental foods to persons with the most serious medical conditions. Of the 86 comment letters that addressed the proposed revisions to Food Package III, 74 commenters (38 form letters) agreed with the proposed changes, especially the addition of supplemental foods other than WIC formula, cereal and juice that are currently authorized. Twelve commenters (5 form letters) disagreed with the proposed revisions. Commenters remarked on a few specific provisions. While agreeing with the majority of provisions, 21 commenters (19 form letters) from State and local agencies asked that FNS clarify the scope of Food Package III since infants receiving an exempt infant formula for a medical condition would now be served under that package rather than under Food Packages I and II as in current regulations. These same commenters wanted clarification on the qualifying conditions that would allow a participant to receive Food Package III. FNS realizes that serving infants with certain medical conditions under Food Package III rather than under Food Packages I and II will be a major change for WIC staff. As stated in the preamble of the proposed rule, only infant formula would be authorized in Food Packages I and II. Infant formula is a food substitute for human milk for generally healthy, full-term infants. Infant formula includes milk-based, soy-based and lactose-free products. Therefore, infants served under Food Packages I and II will be generally healthy, full-term infants. Conversely, infants with a serious nutritionally-related medical condition that requires an exempt infant formula or WIC-eligible medical food would be served under Food Package III. Women and children with serious medical conditions would also be served under Food Package III. FNS reminds readers that the WIC Works Formula Database, *http://www.nal.usda.gov/wicworks* provides helpful information on the identification and indications for use of infant formulas, exempt infant formulas and WIC-eligible medical foods. Commenters were also concerned about medically fragile infants 6 months of age or greater whose medical condition prevents them from consuming complementary infant foods. Commenters requested that these infants receive more WIC formula in replacement of the nutrition that would result from the addition of complementary foods. FNS finds merit in this concern and therefore will revise the provision in Table 1 of 7 CFR 246.10(e)(9) to allow medically fragile infants 6 months of age or greater whose medical condition prevents them from consuming complementary infant foods (cereal, fruit and vegetables, and meat) to receive exempt infant formula or WIC-eligible medical foods at the same maximum monthly allowance as infants ages 4 through 5 months of the same feeding option. The provision of exempt infant formula or WIC-eligible medical foods for these infants is in lieu of provision of complementary infant foods. In the proposed rule, FNS requested comments on WIC-eligible medical foods. Of the 36 comments received, 21 commenters (14 form letters) agreed with the WIC-eligible medical food provisions and 15 (all form letters) disagreed. As discussed in section IV.A. of this preamble, commenters disagreed with the proposed definition for WIC-eligible medical foods. Of the 27 commenters (14 form letters) who addressed ways to determine nutritional equivalency for other than liquid forms of ready-to-feed

(RTF)medical foods, e.g. bars and puddings, 17 commenters (14 form letters) recommended that protein equivalents be used and 10 commenters felt that the CPA, in consultation with the health care provider, should determine the amount of WIC-eligible medical foods to prescribe, based on a thorough nutritional assessment. One commenter also suggested that FNS consider a serving per day equivalent. FNS has determined that more information is needed about nutritional equivalency for other than liquid RTF forms of WIC-eligible medical foods. FNS will consult with experts from industry as well as the FDA prior to developing guidance for WIC agencies on ways to determine nutritional equivalency for various physical forms of WIC-eligible medical foods. D. Implementation Timeframe for Revised Food Packages FNS proposed a one-year implementation timeframe for the majority of the revisions to the WIC food packages, with the following exceptions—(1) a six-month timeframe was proposed for the elimination of juice for infants; and

(2)a limitation was proposed on the ability to implement the partially breastfeeding food packages for infants and women to not more than 32 sites within up to eight selected State agencies so that FNS could examine the effects of the revisions on the initiation and duration of breastfeeding before allowing full implementation by all State agencies. Of the 203 commenters (137 form letters) who addressed the proposed one-year implementation of the revised food package changes for pregnant, postpartum, and fully breastfeeding women, fully formula fed and fully breastfeeding infants, children, and participants with certain medical conditions, 191 commenters (135 form letters) were opposed. Commenters asked for a longer implementation timeframe due to the complexity of the provisions, changes to management information systems, and training needs of staff, vendors and participants. FNS is, therefore, extending the timeframe for implementation of these new food packages to 18 months after the effective date of this interim rule. A total of 611 commenters (501 form letters) addressed the proposed implementation plan for the partially breastfeeding food packages for infants and women. Of these, 590 commenters (501 form letters) were strongly opposed to the plan. Commenters stated that deferring access to these packages denies WIC Programs a vital tool to encourage women to breastfeed and unnecessarily delays participant access to the proposed improvements in these food packages. Commenters also expressed concern that offering both new and old food packages for up to 3 years after implementing the new food packages would create an administrative burden for State agencies and could cause confusion for WIC participants. Finally, commenters pointed out that under the proposed implementation plan, partially breastfed infants 6 months to 11 months old could receive more infant formula than fully formula fed infants. In light of the viewpoints expressed by commenters, and as a result of further review and determination by FNS, the implementation timeframe for the partially breastfeeding food packages for infants and women is revised to be concurrent with implementation of the other food packages—18 months from the effective date of this interim rule. FNS remains committed to examining the impact of the significant changes to these food packages on the breastfeeding mother/infant dyad, and is developing a study design that allows an assessment of the effects of these changes without delaying national implementation. In addition, FNS encourages State WIC agencies to examine the impact of these food package changes in the first month following birth on breastfeeding initiation, intensity and duration and to share the results with FNS and the WIC community. The following chart summarizes the revised implementation timeframes for all food package changes. Timelines for Implementation of Food Package Changes Food package category Who must implement Timeframe for implementation Pregnant Women All State Agencies 18 Months from Effective Date of Interim Rule. Postpartum Women All State Agencies 18 Months from Effective Date of Interim Rule. Fully Breastfeeding Women All State Agencies 18 Months from Effective Date of Interim Rule. Partially Breastfeeding Women All State Agencies 18 Months from Effective Date of Interim Rule. Fully Formula fed Infants All State Agencies 18 Months from Effective Date of Interim Rule. Partially Breastfed Infants All State Agencies 18 Months from Effective Date of Interim Rule. Fully Breastfed Infants All State Agencies 18 Months from Effective Date of Interim Rule. Juice Elimination from Infant Food Packages All State Agencies 18 Months from Effective Date of Interim Rule. Children All State Agencies 18 Months from Effective Date of Interim Rule. Participants with Certain Medical Conditions (Women, Infants and Children) All State Agencies 18 Months from Effective Date of Interim Rule. During the 18-month phase-in period, State agencies are required to issue food benefits based on either the new food packages or current food packages but may not combine the two. For example, a State agency may not add whole wheat bread and fresh fruits and vegetables to the current foods and quantities available under the children's food package. The State agency may, however, phase-in the new food packages on a participant category basis. To minimize participant and vendor confusion, once the State agency begins issuing the new food packages, it must be done on a Statewide basis. FNS will collaborate with the National WIC Association on developing recommendations and options for rolling out the new food packages, based on ease of administration and other issues. State agencies must, however, roll out the food packages for the partially breastfeed mother/infant dyad concurrently, and are also strongly encouraged to concurrently roll out the food packages for the fully breastfed mother/infant dyad. V. Endnotes

(1)U.S. Department of Health and Human Services/U.S. Department of Agriculture, Dietary Guidelines for Americans, 2005. Available at Internet site: *http://www.healthierus.gov/dietaryguidelines/* .

(2)Institute of Medicine, National Academy of Sciences. “WIC Food Packages: Time for a Change,” 2005. Available at Internet site: *http://www.fns.usda.gov/oane/menu/Published/WIC/FILES/Time4AChange(mainrpt).pdf* .

(3)Institute of Medicine, National Academy of Sciences, 2002a. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academy Press.

(4)Environmental Protection Agency/Food and Drug Administration. “What You Need to Know About Mercury in Fish and Shellfish.” EPA and FDA Advice for: Women Who Might Become Pregnant, Women Who Are Pregnant, Nursing Mothers, and Young Children. 2004. Available at Internet site: *http://www.cfsan.fda.gov/dms/admehg3.html* . VI. Procedural Matters Executive Order 12866 This interim rule has been determined to be economically significant and was reviewed by the Office Management and Budget in conformance with Executive Order 12866. Regulatory Impact Analysis As required for all rules that have been designated as Significant by the Office of Management and Budget, a Regulatory Impact Analysis

(RIA)was developed for this interim rule. It follows this regulation as an Appendix. The conclusions of this analysis are summarized below. *Need for Action.* As the population served by WIC has grown and become more diverse over the last 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. A rule is needed to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science. *Benefits.* Benefits of this rule include bringing the WIC food packages in line with the Dietary Guidelines for Americans

(1)and current infant feeding practice guidelines of the American Academy of Pediatrics, better promoting and supporting the establishment of successful long-term breastfeeding, providing WIC participants with a wider variety of food, providing WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences, and serving all participants with certain medical conditions under one food package to facilitate efficient management of medically fragile participants. *Costs.* FNS estimates that the provisions in this interim rule will have minimal impact on total costs over 5 years. Regulatory Flexibility Act This interim rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C 601-612). Nancy Montanez Johner, Under Secretary, Food, Nutrition and Consumer Services, has certified that this rule will not have a significant economic impact on a substantial number of small entities. State and local agencies and WIC participants will be most affected by the rule and WIC authorized vendors and the food industry may be indirectly affected. Although not required by the Regulatory Flexibility Act, FNS has prepared a Regulatory Flexibility Analysis

(RFA)describing the impact of this interim rule on small entities. The RFA reflects comments that were received on the Initial Regulatory Flexibility Analysis that was included in the WIC Food Package Proposed Rule published at 71 FR 44784. Additional analysis of the regulatory flexibility considerations of this interim rule may be found in the Regulatory Impact Analysis section of this preamble and the cited RIA itself. Need For, and Objectives of, the Interim Rule This interim rule revises regulations governing the WIC food packages to change the maximum monthly allowances and minimum requirements for certain supplemental foods, and add new foods such as fruits, vegetables and whole grains. The revisions largely reflect recommendations made by the Institute of Medicine of the National Academies in its Report “WIC Food Packages: Time for a Change.”

(2)These revisions bring the WIC food packages in line with the Dietary Guidelines for Americans

(1)and current infant feeding practice guidelines of the American Academy of Pediatrics, better promote and support the establishment of successful long-term breastfeeding, provide WIC participants with a wider variety of food, and provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences. Description and Estimate of Number of Small Entities To Which the Interim Rule Would Apply This interim rule applies to WIC State agencies with respect to their selection of foods to be included on their food lists. As a result, vendors will be indirectly affected and the food industry will realize increased sales of some foods and decreases in other foods, with an overall neutral effect on sales nationally. The rule may have an indirect economic affect on certain small businesses because they may have to carry a larger variety of certain foods to be eligible for authorization as a WIC vendor. Currently, approximately 46,000 stores are authorized to accept WIC food instruments, some of which are small businesses. With the high degree of State flexibility allowable under this interim rule, small vendors will be impacted differently in each State depending upon how that State chooses to meet the new requirements. It is, therefore, not feasible to accurately estimate the rule's impact on small vendors. Since neither FNS nor the State agencies regulate food producers under the WIC Program, it is not known how many small entities within that industry may be indirectly affected by the interim rule. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements This interim rule provides State agencies with greater flexibility in prescribing food packages to WIC participants. The information collection burden estimated for this rule is 14,598 hours. The burden reflects requirements associated with medical documentation for the issuance of any supplemental foods issued to participants who receive Food Package III; any authorized soy-based beverage or tofu issued to children who receive Food Package IV; and, any additional authorized tofu and cheese issued to women who receive Food Packages V and VII that exceeds the maximum substitution rate. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered FNS has considered significant alternatives in developing this interim rule including those that may reduce the indirect impact on small business. These considerations include (among others) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for small entities; the use of performance, rather than design, standards; and an exemption from coverage of the rule, or any part thereof, for small entities. In general, the alternatives of exempting small entities from the requirements in this interim rule or altering the requirements for small entities were rejected. The WIC food packages provide supplemental foods designed to address the nutritional needs of low-income pregnant, breastfeeding, non-breastfeeding postpartum women, infants and children up to age five who are at nutritional risk. Exempting small entities from providing the specific foods intended to address the nutritional needs of participants or altering the requirements for small entities would undermine the purpose of the WIC Program and endanger the health status of participants. FNS has, however, modified the new food provision in an effort to mitigate the impact on small entities. Currently, State agencies must establish minimum requirements for the variety and quantity of foods that a vendor must stock in order to receive WIC Program authorization. This rule adds new food items, such as fruits and vegetables and whole grain breads, which may require some WIC vendors, particularly smaller stores, to expand the types and quantities of food items stocked in order to maintain their WIC authorization. In addition, vendors also have to make available more than one food type from each WIC food category, except for the categories of peanut butter and eggs, which may be a change for some vendors. To mitigate the impact of the fruit and vegetable requirement, the rule allows canned, frozen and dried fruits and vegetables to be substituted for fresh produce. Federal Rules That May Duplicate, Overlap, or Conflict With the Interim Rule There are no Federal rules that may duplicate, overlap, or conflict with the provisions of this interim rule. Public Law 104-4, Unfunded Mandates Reform Act of 1995

(UMRA)Title II of the UMRA establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under Section 202 of the UMRA, FNS generally must prepare a written statement, including a cost/benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, or tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires FNS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule. This interim rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) that impose costs on State, local, or tribal governments or to the private sector of $100 million or more in any one year. This rule is, therefore, not subject to the requirements of sections 202 and 205 of the UMRA. Executive Order 12372 The Special Supplemental Nutrition Program for Women, Infants and Children

(WIC)is listed in the Catalog of Federal Domestic Assistance under No. 10.557. For reasons set forth in the final rule in 7 CFR part 3015, Subpart V and related Notice (48 FR 29114, June 24, 1983), this Program is included in the scope of Executive Order 12372, which requires intergovernmental consultation with State and local officials. Federalism Summary Impact Statement Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13132. Prior Consultation With WIC State and Local Agency Officials Over the years FNS has received numerous requests from WIC State and local agencies to modify the current food packages to permit greater substitution of foods or introduction of additional foods. These requests have come from formal and informal discussions and with State and local officials on an ongoing basis regarding program implementation and food package policy issues, and from written proposals and comments submitted to FNS by WIC State and local agencies to allow modifications and/or substitutions to the WIC food packages. Requests for revisions to the WIC food packages have also been received from Congress, participants, and organizations with interests in the welfare of WIC participants. Examples of the different forums and methods FNS has used over the years to solicit WIC State and local agency staff input on the WIC food packages include the following. • Publishing an advanced notice of proposed rulemaking

(ANPR)in 2003 to solicit comments to determine if the WIC food packages should be revised to better improve the nutritional intake, health and development of participants; and, if so, what specific changes should be made to the food packages. In response to the ANPR, FNS received 195 total comments; • Commissioning the National Academies' Institute of Medicine

(IOM)to independently review the WIC Food Packages. IOM solicited public comment on revisions to the WIC food packages, via 3 public hearings, letters and e-mail, throughout its 22-month study period. IOM considered these comments, as well as comments FNS received in response to the ANPR, in developing recommendations to revise the WIC food packages. IOM published its reports of these recommendations on April 27, 2005: “WIC Food Packages: Time for a Change.”

(2)This rule incorporates IOM's recommendations; • Hosting annual meetings (1977-present) of the National Advisory Council on Maternal, Infant and Fetal Nutrition that includes WIC staff as members of the Council; the Council develops recommendations for FNS on how to improve operations of the WIC and Commodity Supplemental Food Programs, including aspects related to the authorized foods and food packages; and • Consulting and collaborating with NWA on a wide variety of WIC issues, including those related to the WIC food packages (1983-present). NWA is a non-profit organization that was founded in 1983 by State and local agencies that administer the WIC Program. In 2006, NWA's paid membership included 75 of the 89 WIC State agencies, 675 local agencies, 5 State WIC Associations, and 19 sustaining members (i.e., for-profit and non-profit businesses or organizations). Functioning as a coalition of WIC agencies, NWA is dedicated to maximizing WIC resources through effective management practices. NWA also serves in a leadership role for WIC agencies by developing position papers on issues of concern to the WIC community. Nature of Concerns and the Need To Issue This Rule • Congress has requested a WIC food package rule that includes fruits and vegetables and allows for cultural food accommodations and responds to the needs of the WIC population. • The National Advisory Council on Maternal, Infant, and Fetal Nutrition, in its annual Reports to FNS, recommends better accommodation of the nutritional and cultural needs of WIC participants through the WIC food packages; and • In 1999, NWA (then the National Association of WIC Directors (NAWD)) published a position paper entitled “NAWD WIC Food Prescription Recommendations” and in 2003, NWA published a position paper entitled “NWA WIC Culturally Sensitive Food Prescription Recommendations.” NWA's major recommendations in these two reports were to reframe the WIC food packages to be consistent with the Dietary Guidelines for Americans and allow State agencies flexibility to accommodate cultural eating patterns. Based upon the need to address the nutritional needs of the WIC population given current scientific information and consumption patterns as exemplified by the concerns and recommendations of NWA, and others, FNS was aware of the need to revise the WIC food packages. Extent to Which We Meet Those Concerns FNS has considered the impact of the interim rule on State and local agencies. FNS believes that the rule is responsive to the expressed concerns and requests of commenters representing State and local concerns. A few commenters stated that the Department did not conduct a regulatory risk assessment as required for certain Departmental regulations under section 304 of the Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994, Public Law 103-354. However, based on the statutory language and legislative intent, the Department determined that a regulatory risk assessment is not required for this regulation. Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full implementation. This rule is not intended to have retroactive effect unless so specified in the DATES paragraph of the preamble of the interim rule. Prior to any judicial challenge to the provisions of this rule or the application of its provisions, all applicable administrative procedures must be exhausted. Civil Rights Impact Analysis FNS has reviewed this interim rule in accordance with FNS Regulation 4300-4, “Civil Rights Impact Analysis,” to identify and address any major civil rights impacts the rule might have on minorities, women, and persons with disabilities. After a careful review of the rule's intent and provisions, and the characteristics of WIC Program applicants and participants, FNS has determined that it does not have a deleterious effect on the participation of protected individuals in the WIC Program. All data available to FNS indicate that protected individuals have the same opportunity to participate in the WIC Program as non-protected individuals. FNS specifically prohibits State and local agencies operating the WIC Program from discrimination based on race, color, national origin, sex, age, or disability. Section 246.8(a) of WIC regulations requires State agencies to ensure that no person will be excluded from participation based on race, color, national origin, age, sex or disability. Where State agencies have options, and they choose to implement a certain provision, they must implement it in such a way that it complies with the regulations at 7 CFR 246.8. This rule merely addresses revisions to the WIC food packages to bring them into line with the Dietary Guidelines for Americans

(1)and current infant feeding recommendations from the American Academy of Pediatrics. Several provisions are specifically designed to better accommodate WIC's highly diverse population. This interim rule provides WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences, including allowing participants a broad selection of fruits and vegetables; tofu and soy-based beverage as substitutes for milk; participant choice for whole grains (including tortillas); and salmon and sardines as substitutions for tuna. This interim rule also makes provisions to better accommodate the special dietary needs of high-risk participants served in Food Package III, helping to protect the health and well-being of this nutritionally vulnerable subset of WIC participants. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR part 1320) requires that the Office of Management and Budget

(OMB)approve all collections of information by a Federal agency before they can be implemented. In the publication of the proposed rule on August 7, 2006, FNS solicited comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility and clarity; and ways to minimize the burden on respondents, including the use of automated collection techniques or other forms of information technology. FNS received no public comments in response to this solicitation. On November 1, 2006, OMB filed comment in accordance with 5 CFR 1320.11(c), requiring FNS to review public comments in response to the proposed rule and address any such comments in the preamble of the final rule. As a result, FNS has submitted a new clearance package for OMB review and approval. These information collection requirements will not become effective until approved by OMB. When OMB has approved these information collection requirements, FNS will publish separate action in the **Federal Register** . E-Government Act Compliance The Food and Nutrition Service is committed to complying with the E-Government Act to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. List of Subjects in 7 CFR Part 246 Administrative practice and procedure, Civil rights, Food assistance programs, Grant programs—health, Grant programs—social programs, Indians, Infants and children, Maternal and child health, Nutrition, Penalties, Reporting and recordkeeping requirements, Women. For reasons set forth in the preamble, 7 CFR Part 246 is amended as follows: PART 246—SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND CHILDREN 1. The authority citation for part 246 continues to read as follows: Authority: 42 U.S.C. 1786. 2. In § 246.2: a. Add new definitions of “Cash-value voucher” and “Farmer” in alphabetical order; b. Amend the definitions of “Compliance buy”, “Employee fraud and abuse”, “Participants” and “Proxy” by removing the words “food instruments” and adding in their place the words “food instruments or cash-value vouchers”; c. Amend the definition “Nutrition Services and Administration

(NSA)Costs” by removing the words “food instruments” and adding in their place the words “food instruments and cash-value vouchers”; d. Revise the definition of “Participant violation”; e. Revise the definition of “Participation”; and f. Amend the definition of “WIC-eligible medical foods” by removing the words “with a diagnosed medical condition” and adding in their place the words “with a qualifying condition”, and by revising the second sentence. The additions and revisions read as follows: § 246.2 Definitions. *Cash-value voucher* means a fixed-dollar amount check, voucher, electronic benefit transfer

(EBT)card or other document which is used by a participant to obtain authorized fruits and vegetables. *Farmer* means an individual authorized by the State agency to sell eligible fruits and vegetables to participants at a farmers' market or roadside stands. Individuals who exclusively sell produce grown by someone else, such as wholesale distributors, cannot be authorized. *Participant violation* means any intentional action of a participant, parent or caretaker of an infant or child participant, or proxy that violates Federal or State statutes, regulations, policies, or procedures governing the Program. Participant violations include intentionally making false or misleading statements or intentionally misrepresenting, concealing, or withholding facts to obtain benefits; exchanging cash-value vouchers, food instruments or supplemental foods for cash, credit, non-food items, or unauthorized food items, including supplemental foods in excess of those listed on the participant's food instrument; threatening to harm or physically harming clinic, farmer or vendor staff; and dual participation. *Participation* means the sum of:

(1)The number of persons who received supplemental foods or food instruments during the reporting period;

(2)The number of infants who did not receive supplemental foods or food instruments but whose breastfeeding mother received supplemental foods or food instruments during the report period; and

(3)The number of breastfeeding women who did not receive supplemental foods or food instruments but whose infant received supplemental foods or food instruments during the report period. *WIC-eligible medical foods* * * * Such WIC-eligible medical foods must serve the purpose of a food, meal or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and may not be a conventional food, drug, flavoring, or enzyme.* * * 3. In § 246.4: a. Revise paragraph (a)(11)(iii). b. Amend paragraph (a)(14)(iii) by revising the heading and the first sentence; c. Revise paragraph (a)(14)(vi); d. Revise paragraph (a)(14)(xi); e. Amend paragraph (a)(14)(xii) by removing the words “food instrument” wherever they appear and adding in their place the words “food instrument and cash-value voucher”; f. Amend paragraph (a)(21) by removing the words “food instruments” and adding in their place the words “food instruments and cash-value vouchers”; and g. Amend paragraph (a)(25)(iii) by removing the words “food instruments” and adding in their place the words “food instruments, cash-value vouchers”. The revisions read as follows: § 246.4 State plan.

(a)* * *

(11)* * *

(iii)Instructions concerning all food delivery operations performed at the local level, including the list of acceptable foods and their maximum monthly quantities as required by § 246.10(b)(1).

(14)* * *

(iii)*Vendor and farmer agreement.* A sample vendor and farmer, if applicable, agreement, including the sanction schedule, which may be incorporated as an attachment or, if the sanction schedule is in the State agency's regulations, through citation to the regulations. * * *

(vi)*Food instruments and cash-value vouchers.* A facsimile of the food instrument and cash-value voucher, if used, and a description of the system the State agency will use to account for the disposition of food instruments and cash value vouchers in accordance with § 246.12(q);

(xi)*Vendor and farmer training.* The procedures the State agency will use to train vendors in accordance with § 246.12(i) and farmers. State agencies that intend to delegate any aspect of training to a local agency, contractor, or vendor representative must describe the State agency supervision and instructions that will be provided to ensure the uniformity and quality of vendor training. 4. In § 246.7: a. Amend paragraphs (c)(2)(i) and (f)(2)(i) by removing the words “food or food instruments” and adding in their place the words “ food, cash-value vouchers or food instruments”; and b. Revise paragraphs (f)(2)(iv), (h)(3)(i), (j)(3) and (j)(6). The revisions read as follows: § 246.7 Certification of participants.

(f)* * *

(2)* * *

(iv)Each local agency using a retail purchase system shall issue a food instrument(s) and if applicable cash-value voucher(s) to the participant at the same time as notification of certification. Such food instrument(s) and cash-value vouchers shall provide benefits for the current month or the remaining portion thereof and shall be redeemable immediately upon receipt by the participant. Local agencies may mail the initial food instrument(s) and if applicable cash-value vouchers with the notification of certification to those participants who meet the criteria for the receipt of food instruments through the mail, as provided in § 246.12(r)(4).

(h)* * *

(3)* * *

(i)A State agency may allow local agencies to disqualify a participant for failure to obtain food instruments, cash-value vouchers or supplemental foods for several consecutive months. As specified by the State agency, proof of such failure includes failure to pick up supplemental foods, cash-value vouchers or food instruments, nonreceipt of food instruments or cash-value vouchers (when mailed instruments or vouchers are returned), or failure to have an electronic benefit transfer card revalidated for purchase of supplemental foods; or

(j)* * *

(3)If the State agency implements the policy of disqualifying a participant for not picking up supplemental foods, cash-value vouchers or food instruments in accordance with paragraph (h)(3)(i) of this section, it shall provide notice of this policy and of the importance of regularly picking up cash-value vouchers, food instruments or supplemental foods to each participant, parent or caretaker at the time of each certification.

(6)A person who is about to be suspended or disqualified from program participation at any time during the certification period shall be advised in writing not less than 15 days before the suspension or disqualification. Such notification shall include the reasons for this action, and the participant's right to a fair hearing. Further, such notification need not be provided to persons who will be disqualified for not picking up cash-value vouchers, supplemental foods or food instruments in accordance with paragraph (h)(3)(i) of this section. 5. Revise § 246.10 to read as follows: § 246.10 Supplemental foods.

(a)*General.* This section prescribes the requirements for providing supplemental foods to participants. The State agency must ensure that local agencies comply with this section.

(b)*State agency responsibilities.*

(1)State agencies may:

(i)Establish criteria in addition to the minimum Federal requirements in Table 4 of paragraph (e)(12) of this section, except that the State agency may not establish further restrictions on the eligible fruits and vegetables, for the supplemental foods in their States. These State criteria could address, but not be limited to, other nutritional standards, competitive cost, State-wide availability, and participant appeal; and

(ii)Make food package adjustments to better accommodate participants who are homeless. At the State agency's option, these adjustments would include, but not be limited to, issuing authorized supplemental foods in individual serving-size containers to accommodate lack of food storage or preparation facilities.

(2)State agencies must:

(i)Identify the brands of foods and package sizes that are acceptable for use in the Program in their States in accordance with the requirements of this section. State agencies must also provide to local agencies, and include in the State Plan, a list of acceptable foods and their maximum monthly allowances as specified in Tables 1 through 4 of paragraphs (e)(9) through (e)(12) of this section; and

(ii)Ensure that local agencies:

(A)Make available to participants the maximum monthly allowances of authorized supplemental foods, except as noted in paragraph

(c)of this section, and abide by the authorized substitution rates for WIC food substitutions as specified in Tables 1 through 3 of paragraphs (e)(9) through (e)(11) of this section;

(B)Make available to participants more than one food from each WIC food category except for the categories of peanut butter and eggs, and any of the WIC-eligible fruits and vegetables (fresh or processed) in each authorized food package as listed in paragraph

(e)of this section;

(C)Authorize only a competent professional authority to prescribe the categories of authorized supplemental foods in quantities that do not exceed the regulatory maximum and are appropriate for the participant, taking into consideration the participant's age and nutritional needs; and

(D)Advise participants or their caretaker, when appropriate, that the supplemental foods issued are only for their personal use. However, the supplemental foods are not authorized for participant use while hospitalized on an in-patient basis. In addition, consistent with § 246.7(m)(1)(i)(B), supplemental foods are not authorized for use in the preparation of meals served in a communal food service. This restriction does not preclude the provision or use of supplemental foods for individual participants in a nonresidential setting (e.g., child care facility, family day care home, school, or other educational program); a homeless facility that meets the requirements of § 246.7(m)(1); or, at the State agency's discretion, a residential institution (e.g., home for pregnant teens, prison, or residential drug treatment center) that meets the requirements currently set forth in § 246.7(m)(1) and (m)(2).

(c)*Nutrition tailoring.* The full maximum monthly allowances of all supplemental foods in all food packages must be made available to participants if medically or nutritionally warranted. Reductions in these amounts cannot be made for cost-savings, administrative convenience, caseload management, or to control vendor abuse. Reductions in these amounts cannot be made for categories, groups or subgroups of WIC participants. The provision of less than the maximum monthly allowances of supplemental foods to an individual WIC participant in all food packages is appropriate only when:

(1)Medically or nutritionally warranted (e.g., to eliminate a food due to a food allergy);

(2)A participant refuses or cannot use the maximum monthly allowances; or

(3)The quantities necessary to supplement another programs' contribution to fill a medical prescription would be less than the maximum monthly allowances.

(d)*Medical documentation* —(1) *Supplemental foods requiring medical documentation* . Medical documentation is required for the issuance of the following supplemental foods:

(i)Any non-contract brand infant formula;

(ii)Any infant formula prescribed to a child or adult who receives Food Package III;

(iii)Any exempt infant formula;

(iv)Any WIC-eligible medical food;

(v)Any authorized supplemental food issued to participants who receive Food Package III;

(vi)Any authorized soy-based beverage or tofu issued to children who receive Food Package IV;

(vii)Any additional authorized cheese issued to children who receive Food Package IV that exceeds the maximum substitution rate;

(viii)Any additional authorized tofu and cheese issued to women who receive Food Packages V and VII that exceeds the maximum substitution rate; and

(ix)Any contract brand infant formula that does not meet the requirements in Table 4 of paragraph (e)(12) of this section.

(2)*Supplemental foods not requiring medical documentation.*

(i)State agencies may authorize local agencies to issue a non-contract brand infant formula that meets the requirements in Table 4 of paragraph (e)(12) of this section without medical documentation in order to meet religious eating patterns; and

(ii)The State agency has the discretion to require medical documentation for any contract brand infant formula and may decide that some contract brand infant formula may not be issued under any circumstances.

(3)*Medical Determination.* For purposes of this program, medical documentation means that a health care professional licensed to write medical prescriptions under State law has:

(i)Made a medical determination that the participant has a qualifying condition as described in paragraphs (e)(3) through (e)(7) of this section that dictates the use of the supplemental foods, as described in paragraph (d)(1) of this section; and

(ii)Provided the written documentation that meets the technical requirements described in paragraphs (d)(4)(ii) and (d)(4)(iii) of this section.

(4)*Technical Requirements* —(i) *Location.* All medical documentation must be kept on file (electronic or hard copy) at the local clinic. The medical documentation kept on file must include the initial telephone documentation, when received as described in paragraph (d)(4)(iii)(B) of this section.

(ii)*Content.* All medical documentation must include the following:

(A)The name of the authorized WIC formula (infant formula, exempt infant formula, WIC-eligible medical food) prescribed, including amount needed per day;

(B)The authorized supplemental food(s) appropriate for the qualifying condition(s) and their prescribed amounts;

(C)Length of time the prescribed WIC formula and/or supplemental food is required by the participant;

(D)The qualifying condition(s) for issuance of the authorized supplemental food(s) requiring medical documentation, as described in paragraphs (e)(3) through (e)(7) of this section; and

(E)Signature, date and contact information (or name, date and contact information), if the initial medical documentation was received by telephone and the signed document is forthcoming, of the health care professional licensed by the State to write prescriptions in accordance with State laws.

(iii)*Written confirmation* —(A) *General.* Medical documentation must be written and may be provided as an original written document, an electronic document, by facsimile or by telephone to a competent professional authority until written confirmation is received.

(B)*Medical documentation provided by telephone.* Medical documentation may be provided by telephone to a competent professional authority who must promptly document the information. The collection of the required information by telephone for medical documentation purposes may only be used until written confirmation is received from a health care professional licensed to write medical prescriptions and used only when absolutely necessary on an individual participant basis. The local clinic must obtain written confirmation of the medical documentation within a reasonable amount of time ( *i.e.* , one or two week's time) after accepting the initial medical documentation by telephone.

(5)*Medical supervision requirements.* Due to the nature of the health conditions of participants who are issued supplemental foods that require medical documentation, close medical supervision is essential for each participant's dietary management. The responsibility remains with the participant's health care provider for this medical oversight and instruction. This responsibility cannot be assumed by personnel at the WIC State or local agency. However, it would be the responsibility of the WIC competent professional authority to ensure that only the amounts of supplemental foods prescribed by the participant's health care provider are issued in the participant's food package.

(e)*Food packages.* There are seven food packages available under the Program that may be provided to participants. The authorized supplemental foods must be prescribed from food packages according to the category and nutritional needs of the participant. The food packages are as follows:

(1)*Food Package I—Infants birth through 5 months* —(i) *Participant category served.* This food package is designed for issuance to infant participants from birth through age 5 months who do not have a condition qualifying them to receive Food Package III.

(ii)*Infant feeding categories* —(A) *Birth to one month.* Three infant feeding options are available during the first month after birth—fully breastfeeding, i.e., the infant receives no infant formula from the WIC Program; partially breastfeeding, *i.e.* , the infant receives not more than 104 reconstituted fluid ounces of formula; or fully formula-feeding. Infant formula is not provided during the first month after birth to fully breastfed infants to support the successful establishment of breastfeeding.

(B)*One through 5 months.* Three infant feeding options are available from 1 months through 5 months—fully breastfeeding, fully formula-feeding, or partially breastfeeding, *i.e.* , the infant is breastfed but also receives infant formula from the WIC Program in an amount not to exceed approximately half the amount of infant formula allowed for a fully formula fed infant.

(iii)*Infant formula requirements.* This food package provides iron-fortified infant formula that is not an exempt infant formula. The issuance of any contract brand or noncontract brand infant formula that contains less than 10 milligrams of iron per liter at standard dilution ( *i.e.* , approximately 20 kilocalories per fluid ounce of prepared formula) is prohibited. Except as specified in paragraph

(d)of this section, local agencies must issue a contract brand infant formula that meets the requirements in Table 4 of paragraph (e)(12) of this section.

(iv)*Physical forms.* Local agencies must issue all WIC formulas (WIC formulas mean all infant formula, exempt infant formula and WIC-eligible medical foods) in concentrated liquid or powder physical forms. Ready-to-feed WIC formulas may be authorized when the competent professional authority determines and documents that:

(A)The participant's household has an unsanitary or restricted water supply or poor refrigeration;

(B)The person caring for the participant may have difficulty in correctly diluting concentrated or powder forms; or

(C)The WIC infant formula is only available in ready-to-feed.

(v)*Authorized category of supplemental foods.* Infant formula is the only category of supplemental foods authorized in this food package. Exempt infant formulas and WIC-eligible medical foods are authorized only in Food Package III.

(2)*Food Package II—Infants 6 through 11 months* —(i) *Participant category served.* This food package is designed for issuance to infant participants from 6 through 11 months of age who do not have a condition qualifying them to receive Food Package III.

(ii)*Infant feeding options.* Three infant feeding options are available—fully breastfeeding, fully formula-feeding, or partially breastfeeding.

(iii)*Infant formula requirements.* The requirements for issuance of infant formula in Food Package I, specified in paragraphs (e)(1)(iii) and (e)(1)(iv) of this section, also apply to the issuance of infant formula in Food Package II.

(iv)*Authorized categories of supplemental foods.* Infant formula, infant fruits and vegetables, infant meat, and infant cereal are the categories of supplemental foods authorized in this food package.

(3)*Food Package III—Participants with qualifying conditions* —(i) *Participant category served and qualifying conditions.* This food package is reserved for issuance to women, infants and child participants who have a documented qualifying condition that requires the use of a WIC formula (infant formula, exempt infant formula or WIC-eligible medical food) because the use of conventional foods is precluded, restricted, or inadequate to address their special nutritional needs. Medical documentation must meet the requirements described in paragraph

(d)of this section. Participants who are eligible to receive this food package must have one or more qualifying conditions, as determined by a health care professional licensed to write medical prescriptions under State law. The qualifying conditions include but are not limited to premature birth, low birth weight, failure to thrive, inborn errors of metabolism and metabolic disorders, gastrointestinal disorders, malabsorption syndromes, immune system disorders, severe food allergies that require an elemental formula, and life threatening disorders, diseases and medical conditions that impair ingestion, digestion, absorption or the utilization of nutrients that could adversely affect the participant's nutrition status. This food package may not be issued solely for the purpose of enhancing nutrient intake or managing body weight.

(ii)*Non-authorized issuance of Food Package III.* This food package is not authorized for:

(A)Infants whose only condition is: ( *1* ) A diagnosed formula intolerance or food allergy to lactose, sucrose, milk protein or soy protein that does not require the use of an exempt infant formula; or ( *2* ) A non-specific formula or food intolerance.

(B)Women and children who have a food intolerance to lactose or milk protein that can be successfully managed with the use of one of the other WIC food packages ( *i.e.* , Food Packages IV-VII); or

(C)Any participant solely for the purpose of enhancing nutrient intake or managing body weight without an underlying qualifying condition.

(iii)*Restrictions on the issuance of WIC formulas in ready-to-feed

(RTF)forms.* WIC State agencies must issue WIC formulas (infant formula, exempt infant formula and WIC-eligible medical foods) in concentrated liquid or powder physical forms unless the requirements for issuing RTF are met as described in paragraph (e)(1)(iv) of this section. In addition to those requirements, there are two additional conditions which may be used to issue RTF in Food Package III:

(A)If a ready-to-feed form better accommodates the participant's condition; or

(B)If it improves the participant's compliance in consuming the prescribed WIC formula.

(iv)*Unauthorized WIC costs.* All apparatus or devices ( *e.g.* , enteral feeding tubes, bags and pumps) designed to administer WIC formulas are not allowable WIC costs.

(v)*Authorized categories of supplemental foods* . The supplemental foods authorized in this food package require medical documentation for issuance and include infant formula (for children or women), exempt infant formula, WIC-eligible medical foods, infant cereal, infant food fruits and vegetables, milk and milk alternatives, cheese, eggs, canned fish, fruits and vegetables, breakfast cereal, whole wheat bread or other whole grains, juice, legumes and/or peanut butter.

(vi)*Coordination with medical payors and other programs that provide or reimburse for formulas* . WIC State agencies must coordinate with other Federal, State or local government agencies or with private agencies that operate programs that also provide or could reimburse for exempt infant formulas and WIC-eligible medical foods benefits to mutual participants. At a minimum, a WIC State agency must coordinate with the State Medicaid Program for the provision of exempt infant formulas and WIC-eligible medical foods that are authorized or could be authorized under the State Medicaid Program for reimbursement and that are prescribed for WIC participants who are also Medicaid recipients. The WIC State agency is responsible for providing up to the maximum amount of exempt infant formulas and WIC-eligible medical foods under Food Package III in situations where reimbursement is not provided by another entity.

(4)*Food Package IV—Children 1 through 4 years* —(i) *Participant category served* . This food package is designed for issuance to participants 1 through 4 years of age who do not have a condition qualifying them to receive Food Package III.

(ii)*Authorized categories of supplemental foods* . Milk, breakfast cereal, juice, fruits and vegetables, whole wheat bread or other whole grains, eggs, and legumes or peanut butter are the categories of supplemental foods authorized in this food package. Cheese may be substituted for milk in amounts described in Table 2 of paragraph (e)(10) of this section. Substitutions exceeding the maximum substitution allowance of cheese, up to the maximum allowance for fluid milk, may be allowed with medical documentation of the qualifying condition. Soy-based beverage and tofu can be substituted for milk only with medical documentation in this food package, in amounts described in Table 2 of paragraph (e)(10) of this section. A health care professional licensed by the State to write prescriptions must make a medical determination and provide medical documentation that a child cannot drink milk and requires soy-based beverage, tofu, or additional cheese as a substitute for milk. Such determination can be made for situations that include, but are not limited to, milk allergy, severe lactose maldigestion, and vegan diets. Medical documentation must meet the requirements described in paragraph

(d)of this section.

(5)*Food Package V—Pregnant and partially breastfeeding women* —(i) *Participant category served* . This food package is designed for issuance to women participants with singleton pregnancies who do not have a condition qualifying them to receive Food Package III. This food package is also designed for issuance to breastfeeding women participants, up to 1 year postpartum, who do not have a condition qualifying them to receive Food Package III and whose partially breastfed infants receive formula from the WIC program in amounts that do not exceed the maximum allowances described in Table 1 of paragraph (e)(9) of this section. Women participants breastfeeding more than one infant, and women participants pregnant with more than one fetus, are eligible to receive Food Package VII as described in paragraph (e)(7) of this section.

(ii)*Authorized categories of supplemental foods* . Milk, breakfast cereal, juice, fruits and vegetables, whole wheat bread or other whole grains, eggs, legumes and peanut butter are the categories of supplemental foods authorized in this food package. Cheese or calcium-set tofu may be substituted for milk in amounts described in Table 2 of paragraph (e)(10) of this section. Amounts of cheese or calcium-set tofu exceeding the maximum substitution allowances may be allowed with medical documentation of the qualifying condition, up to the maximum allowance for fluid milk. A health care professional licensed by the State to write prescriptions must make a medical determination and provide medical documentation that a woman cannot drink milk and requires additional cheese or calcium-set tofu. Such determination can be made for situations that include, but are not limited to, milk allergy or severe lactose maldigestion. Medical documentation must meet the requirements described in paragraph

(d)of this section.

(6)*Food Package VI—Postpartum women* —(i) *Participant category served* . This food package is designed for issuance to women up to 6 months postpartum who are not breastfeeding their infants, and to breastfeeding women up to 6 months postpartum whose participating infant receives more than the maximum amount of formula allowed for partially breastfed infants as described in Table 1 of paragraph (e)(9) of this section.

(ii)*Authorized categories of supplemental foods* . Milk, breakfast cereal, juice, fruits and vegetables, eggs, and legumes or peanut butter are the categories of supplemental foods authorized in this food package. Cheese or calcium-set tofu may be substituted for milk in amounts described in Table 2 of paragraph (e)(10) of this section. Amounts of cheese or calcium-set tofu exceeding the maximum substitution allowances may be allowed with medical documentation of the qualifying condition, up to the maximum allowance for fluid milk. A health care professional licensed by the State to write prescriptions must make a medical determination and provide medical documentation that a woman cannot drink milk and requires additional cheese or calcium-set tofu. Such determination can be made for situations that include, but are not limited to, milk allergy or severe lactose maldigestion. Medical documentation must meet the requirements described in paragraph

(d)of this section.

(7)*Food Package VII—Fully breastfeeding* —(i) *Participant category served* . This food package is designed for issuance to breastfeeding women up to 1 year postpartum whose infants do not receive infant formula from WIC (these breastfeeding women are assumed to be fully breastfeeding their infants). This food package is also designed for issuance to women participants pregnant with two or more fetuses, and women participants partially breastfeeding multiple infants. Women participants fully breastfeeding multiple infants receive 1.5 times the supplemental foods provided in Food Package VII.

(ii)*Authorized categories of supplemental foods* . Milk, cheese, breakfast cereal, juice, fruits and vegetables, whole wheat bread or other whole grains, eggs, legumes, peanut butter, and canned fish are the categories of supplemental foods authorized in this food package. Cheese or calcium-set tofu may be substituted for milk in amounts described in Table 2 of paragraph (e)(10) of this section. Amounts of cheese or calcium-set tofu exceeding the maximum substitution allowances may be allowed with medical documentation of the qualifying condition, up to the maximum allowance for fluid milk. A health care professional licensed by the State to write prescriptions must make a medical determination and provide medical documentation that a woman cannot drink milk and requires additional cheese or calcium-set tofu. Such determination can be made for situations that include, but are not limited to, milk allergy or severe lactose maldigestion. Medical documentation must meet the requirements described in paragraph

(d)of this section.

(8)*Supplemental Foods—Maximum monthly allowances, options and substitution rates, and minimum requirements* . Tables 1 through 3 of paragraphs (e)(9) through (e)(11) of this section specify the maximum monthly allowances of foods in WIC food packages and identify WIC food options and substitution rates. Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications of supplemental foods in the WIC food packages.

(9)*Maximum monthly allowances of supplemental foods for infants.* The maximum monthly allowances, options and substitution rates of supplemental foods for infants in Food Packages I, II and III are stated in Table 1 as follows: Table 1.—Maximum Monthly Allowances of Supplemental Foods for Infants in Food Packages I, II and III Foods 1 Fully formula fed

(FF)Food packages I-FF & III-FF A: 0 through 3 months B: 4 through 5 months Food packages II-FF & III-FF 6 through 11 months Partially breastfed (BF/FF) Food packages I-BF/FF & III BF/FF A: 0 to 1 month 2 B: 1 through 3 months 2 C: 4 through 5 months Food packages II-BF/FF & III BF/FF 6 through 11 months Fully breastfed

(BF)Food package I-BF 0 through 5 months Food package II-BF 6 through 11 months WIC Formula 4 5 6 7 A: 806 fl oz reconstituted liquid concentrate or 832 fl oz RTF or 870 fl oz reconstituted powder B: 884 fl oz reconstituted liquid concentrate or 896 fl oz RTF or 960 fl oz reconstituted powder 624 fl oz reconstituted liquid concentrate or 640 fl oz RTF or 696 fl oz reconstituted powder A: 104 fl oz reconstituted powder 3 B: 364 fl oz reconstituted liquid concentrate or 384 fl oz RTF or 435 fl oz reconstituted powder C: 442 fl oz reconstituted liquid concentrate or 448 fl oz RTF or 522 fl oz reconstituted powder 312 fl oz reconstituted liquid concentrate or 320 fl oz RTF or 384 fl oz reconstituted powder Infant cereal 8 24 oz 24 oz 24 oz. Infant food fruits and vegetables 8 9 10 128 oz 128 oz 256 oz. Infant food—meat 8 10 77.5 oz. Table 1 Footnotes: (abbreviations in order of appearance in table): FF = fully formula fed; BF/FF = partially breastfed (i.e., the infant is breastfed but also receives formula from the WIC Program); BF = fully breastfed (i.e., the infant receives no formula through the WIC program). 1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. 2 The powder form is the form recommended for partially breastfed infants ages 0 through 3 months in Food Package I. 3 Liquid concentrate and ready-to-feed

(RTF)may be substituted at rates that provide comparable nutritive value. 4 WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food. Only infant formula may be issued for infants in Food Packages I and II. Exempt infant formula may only be issued for infants in Food Package III. 5 The maximum monthly allowance is specified in reconstituted fluid ounces for liquid concentrate, RTF liquid, and powder forms of infant formula and exempt infant formula. Reconstituted fluid ounce is the form prepared for consumption as directed on the container. 6 If powder infant formula is provided, State agencies must provide at least the number of reconstituted fluid ounces as the maximum allowance for the liquid concentrate form of the same product in the same Food Package up to the maximum monthly allowance for powder. State agencies must issue whole containers that are all the same size. 7 State agencies may round up and disperse whole containers of infant formula over the food package timeframe to allow participants to receive the full authorized nutritional benefit (FNB). State agencies must use the methodology described in accordance with paragraph (h)(1) of this section. 8 State agencies may round up and disperse whole containers of infant foods (infant cereal, fruits and vegetables, and meat) over the Food Package timeframe. State agencies must use the methodology described in accordance with paragraph (h)(2) of this section. 9 Fresh banana may replace up to 16 ounces of infant food fruit at a rate of 1 pound of bananas per 8 ounces of infant food fruit. 10 In lieu of infant foods (cereal, fruit and vegetables, and meat), infants greater than 6 months of age in Food Package III may receive exempt infant formula or WIC-eligible medical foods at the same maximum monthly allowance as infants ages 4 through 5 months of age of the same feeding option.

(10)*Maximum monthly allowances of supplemental foods in Food Packages IV through VII* . The maximum monthly allowances, options and substitution rates of supplemental foods for children and women in Food Package IV through VII are stated in Table 2 as follows: Table 2.—Maximum Monthly Allowances of Supplemental Foods for Children and Women in Food Packages IV, V, VI and VII Foods 1 Children Food package IV 1 through 4 years Women Food package V: Pregnant and partially breastfeeding (up to 1 year postpartum) 2 Food package VI: Postpartum (up to 6 months postpartum) 3 Food package VII: Fully breastfeeding (up to 1 year post-partum) 4 5 Juice, single strength 6 128 fl oz 144 fl oz 96 fl oz 144 fl oz. Milk, fluid 16 qt 7 8 9 10 22 qt. 7 8 11 12 16 qt. 7 8 11 12 24 qt. 7 8 11 12 Breakfast cereal 13 36 oz 36 oz 36 oz 36 oz. Cheese N/A N/A N/A 1 lb. Eggs 1 dozen 1 dozen 1 dozen 2 dozen. Fruits and vegetables 14 15 $6.00 in cash value vouchers $8.00 in cash-value vouchers $8.00 in cash-value vouchers $10.00 in cash-value vouchers. Whole wheat bread or other whole grains 16 2 lb 1 lb N/A 1 lb. Fish (canned) N/A N/A N/A 30 oz. Legumes, dry 17 1 lb 1 lb 1 lb 1 lb. And/or peanut butter Or 18 oz And 18 oz Or 18 oz And 18 oz. Table 2 Footnotes: N/A = the supplemental food is not authorized in the corresponding food package. 1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. 2 Food Package V is issued to two categories of WIC participants: Women participants with singleton pregnancies and breastfeeding women whose partially breastfed infants receive formula from the WIC Program in amounts that do not exceed the maximum formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C, or II-BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 3 Food Package VI is issued to two categories of WIC participants: Non-breastfeeding postpartum women and breastfeeding postpartum women whose partially breastfed infants receive more than the maximum infant formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C or II-BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 4 Food Package VII is issued to three categories of WIC participants: Fully breastfeeding women whose infants do not receive formula from the WIC Program; women pregnant with two or more fetuses; and women fully or partially breastfeeding multiple infants. 5 Women fully breastfeeding multiple infants are prescribed 1.5 times the maximum allowances. 6 Combinations of single-strength and concentrated juices may be issued provided that the total volume does not exceed the maximum monthly allowance for single-strength juice. 7 Whole milk, as specified in FDA standards, is the only type of milk allowed for 1-year-old children (12 through 23 months). Reduced fat milks, as specified in FDA standards, i.e., 2% milk fat, are the only types of milk allowed for children ≥ 24 months of age and women. 8 Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate to fluid milk. When a combination of different milk forms is provided, the full maximum monthly fluid milk allowance must be provided. 9 For children, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. No more than 1 lb. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese may be substituted in cases of lactose intolerance or other qualifying conditions, up to the maximum allowance for fluid milk. 10 For children, soy-based beverage and calcium-set tofu may be substituted for milk only with medical documentation for qualifying conditions. Soy-based beverage may be substituted for milk, with medical documentation, for children in Food Package IV on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk, with medical documentation, for children in Food Package IV at the rate of 1 pound of tofu per 1 quart of milk up to the total maximum allowance of milk. 11 For women, cheese or calcium-set tofu may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk or 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in this manner in Food Packages V and VI; however, no more than 1 pound of cheese may be substituted for milk. A maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, no more than 2 lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions. 12 For women, soy-based beverage may be substituted for milk at the rate of 1 quart of soy-based beverage for 1 quart of milk up to the total maximum monthly allowance of milk. 13 At least one-half of the total number of breakfast cereals on the State agency's authorized food list must have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a “whole grain food with moderate fat content” as defined in Table 4 of paragraph (e)(12) of this section. 14 Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables. Dried fruit and dried vegetables are not authorized for children in Food Package IV. 15 The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as described in § 246.16(j). 16 Brown rice, bulgur (cracked wheat), oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be substituted for whole wheat bread on an equal weight basis. 17 Canned legumes may be substituted for dried legumes at the rate of 64 oz. of canned beans for 1 lb. dried beans. Under Food Packages V and VII, two additional combinations of dry or canned beans/peas are authorized: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry or 128 oz. Canned beans/peas (and no peanut butter) or 36 oz. peanut butter (and no beans).

(11)*Maximum monthly allowances of supplemental foods for children and women with qualifying conditions in Food Package III.* The maximum monthly allowances, options and substitution rates of supplemental foods for participants with qualifying conditions in Food Package III are stated in Table 3 as follows: Table 3.—Maximum Monthly Allowances of Supplemental Foods for Children and Women in Food Package III Foods 1 Children 1 through 4 years Women Pregnant and partially breastfeeding (up to 1 year postpartum) 2 Postpartum (up to 6 months postpartum) 3 Fully breastfeeding, (up to 1 year post-partum) 4 5 Juice, single strength 6 128 fl oz 144 fl oz 96 fl oz 144 fl oz. WIC Formula 7 8 455 fl oz liquid concentrate 455 fl oz liquid concentrate 455 fl oz liquid concentrate 455 fl oz. liquid concentrate. Milk 16 qt 9 10 11 12 22 qt 9 10 13 14 16 qt 9 10 13 14 24 qt. 9 10 13 14 Breakfast cereal 15 16 36 oz 36 oz 36 oz 36 oz. Cheese N/A N/A N/A 1 lb. Eggs 1 dozen 1 dozen 1 dozen 2 dozen. Fruits and vegetables 17 18 $6.00 in cash value vouchers $8.00 in cash value vouchers $8.00 in cash value vouchers $10.00 in cash value vouchers. Whole wheat bread 19 2 lb 1 lb N/A 1 lb. Fish (canned) N/A N/A N/A 30 oz. Legumes, dry 20 1 lb 1 lb 1 lb 1 lb. and/or Peanut butter Or 18 oz And 18 oz Or 18 oz And 18 oz. Table 3 Footnotes: N/A=the supplemental food is not authorized in the corresponding food package. 1 Table 4 of paragraph (e)(12) of this section describes the minimum requirements and specifications for the supplemental foods. 2 Food Package V is issued to two categories of WIC participants—women participants with singleton pregnancies and breastfeeding women whose partially breastfed infants receive formula from the WIC Program in amounts that do not exceed the maximum formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C, or II-BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 3 Food Package VI is issued to two categories of WIC participants—non-breastfeeding postpartum women and breastfeeding postpartum women whose partially breastfed infants receive more than the maximum formula allowances for Food Packages I-BF/FF-A, I-BF/FF-B, I-BF/FF-C or II-BF/FF, as appropriate for the age of the infant as described in Table 1 of paragraph (e)(9) of this section. 4 Food Package VII is issued to three categories of WIC participants—fully breastfeeding women whose infants do not receive formula from the WIC Program; women pregnant with two or more fetuses; and women fully or partially breastfeeding multiple infants. 5 Women fully breastfeeding multiple infants are prescribed 1.5 times the maximum allowances. 6 Combinations of single-strength and concentrated juices may be issued provided that the total volume does not exceed the maximum monthly allowance for single-strength juice. 7 WIC formula means infant formula, exempt infant formula, or WIC-eligible medical food. 8 Powder and Ready-to-Feed may be substituted at rates that provide comparable nutritive value. 9 Whole milk, as specified in FDA standards, is the only type of milk allowed for 1-year-old children (12 through 23 months). Reduced fat milks, as specified in FDA standards, i.e., 2% milk fat, are the only types of milk allowed for children > 24 months of age and women. With medical documentation, whole milk may be substituted for reduced fat milk for children > 24 months of age and women. 10 Evaporated milk may be substituted at the rate of 16 fluid ounces of evaporated milk per 32 fluid ounces of fluid milk or a 1:2 fluid ounce substitution ratio. Dry milk may be substituted at an equal reconstituted rate to fluid milk. When a combination of different milk forms is provided, the full maximum monthly fluid milk allowance must be provided. 11 For children, cheese may be substituted for milk at the rate of 1 pound of cheese per 3 quarts of milk. No more than 1 lb. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese may be substituted in cases of lactose intolerance or other qualifying conditions, up to the maximum allowance for fluid milk. 12 For children, soy-based beverage and tofu may be substituted for milk only with medical documentation for qualifying conditions. Soy-based beverage may be substituted for milk, with medical documentation, for children in Food Package IV on a quart for quart basis up to the total maximum allowance of milk. Tofu may be substituted for milk, with medical documentation, for children in Food Package IV at the rate of 1 pound of tofu per 1 quart of milk up to the total maximum allowance of milk. 13 For women, cheese or calcium-set tofu may be substituted for milk at the rate of l pound of cheese per 3 quarts of milk or 1 pound of tofu per 1 quart of milk. A maximum of 4 quarts of milk can be substituted in this manner in Food Packages V and VI; however, no more than 1 pound of cheese may be substituted for milk. A maximum of 6 quarts of milk can be substituted in this manner in Food Package VII; therefore, no more than 2 lbs. of cheese may be substituted for milk. With medical documentation, additional amounts of cheese or tofu may be substituted, up to the maximum allowances for fluid milk, in cases of lactose intolerance or other qualifying conditions. 14 For women, soy-based beverage may be substituted for milk at the rate of 1 quart of soy-based beverage for 1 quart of milk up to the total maximum monthly allowance of milk. 15 32 dry ounces of infant cereal may be substituted for 36 ounces of breakfast cereal. 16 At least one half of the total number of breakfast cereals on the State agency's authorized food list must have whole grain as the primary ingredient and meet labeling requirements for making a health claim as a “whole grain food with moderate fat content” as defined in Table 4 of paragraph (e)(12) of this section. 17 Processed (canned, frozen, dried) fruits and vegetables may be substituted for fresh fruits and vegetables. Dried fruit and dried vegetables are not authorized for children. 18 The monthly value of the fruit/vegetable cash-value vouchers will be adjusted annually for inflation as described in § 246.16(j). 19 Brown rice, bulgur (cracked wheat), oatmeal, whole-grain barley, soft corn or whole wheat tortillas may be substituted for whole wheat bread on an equal weight basis. 20 Canned legumes may be substituted for dried legumes at the rate of 64 oz of canned beans for 1 lb dried beans. Issuance of two additional combinations of dry or canned beans/peas is authorized for the Pregnant and Partially Breastfeeding (up to 1 year postpartum) category and Fully Breastfeeding (Enhanced) (up to 1 year postpartum) category: 1 lb. Dry and 64 oz. Canned beans/peas (and no peanut butter); or 2 lb. Dry or 128 oz. Canned beans/peas (and no peanut butter) or 36 oz. Peanut butter (and no beans).

(12)*Minimum requirements and specifications for supplemental foods.* Table 4 describes the minimum requirements and specifications for supplemental foods in all food packages: Table 4.—Minimum Requirements and Specifications for Supplemental Foods Categories/foods Minimum requirements and specifications WIC formula: Infant formula All authorized infant formulas must

(1)meet the definition for an infant formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and meet the requirements for an infant formula under section 412 of the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107;

(2)Be designed for enteral digestion via an oral or tube feeding;

(3)Provide at least 10 mg iron per liter (at least 1.8 mg iron/100 kilocalories) at standard dilution;

(4)Provide at least 67 kilocalories per 100 milliliters (approximately 20 kilocalories per fluid ounce) at standard dilution.

(5)Not require the addition of any ingredients other than water prior to being served in a liquid state. Exempt infant formula All authorized exempt infant formula must

(1)meet the definition and requirements for an exempt infant formula under section 412(h) of the Federal Food, Drug, and Cosmetic Act as amended (21 U.S.C. 350a(h)) and the regulations at 21 CFR Parts 106 and 107; and 2) Be designed for enteral digestion via an oral or tube feeding. WIC-eligible medical foods. 1 Certain enteral products that are specifically formulated to provide nutritional support for individuals with a qualifying condition, when the use of conventional foods is precluded, restricted, or inadequate. Such WIC-eligible medical foods must serve the purpose of a food, meal or diet (may be nutritionally complete or incomplete) and provide a source of calories and one or more nutrients; be designed for enteral digestion via an oral or tube feeding; and may not be a conventional food, drug, flavoring, or enzyme. WIC-eligible medical foods include many, but not all, products that meet the definition of medical food in Section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)). Milk and milk alternatives: Cow's milk Must conform to FDA standard of identity for whole, reduced fat, low-fat, or non-fat milks (21 CFR 131.110). Must be pasteurized and contain at least 400 IU of vitamin D per quart (100 IU per cup) and 2000 IU of vitamin A per quart (500 IU per cup). May be flavored or unflavored. May be fluid, shelf-stable, evaporated (21 CFR 131.130), or dried (i.e., powder) (21 CFR 131.147). 2 Cultured Milks. Must conform to FDA standard of identity for cultured milk (21 CFR 131.112—cultured buttermilk, kefir cultured milk, acidophilus cultured milk). Goat milk Must conform to FDA standard of identity for whole, reduced fat, low-fat, or non-fat milks (21 CFR part 131). Must be pasteurized and contain at least 400 IU of vitamin D per quart (100 IU per cup) and 2000 IU of vitamin A per quart (500 IU per cup) following FDA fortification standards (21 CFR part 131). May be flavored or unflavored. May be fluid, shelf-stable, evaporated (21 CFR 131.130), or dried (i.e., powdered) (21 CFR 131.147). 2 Cheese Domestic cheese made from 100 percent pasteurized milk. Must conform to FDA standard of identity (21 CFR Part 133); Monterey Jack, Colby, natural Cheddar, Swiss, Brick, Muenster, Provolone, part-skim or whole Mozzarella, pasteurized processed American, or blends of any of these cheeses are authorized. Cheeses that are labeled low, free, reduced, less or light in the nutrients of sodium, fat or cholesterol are WIC-eligible. 3 Tofu Calcium-set tofu prepared with only calcium salts (e.g., calcium sulfate). May not contain added fats, sugars, oils, or sodium. Soy-based beverage Must be fortified to meet the following nutrient levels: 276 mg calcium per cup, 8 g protein per cup, 500 IU vitamin A per cup, 100 IU vitamin D per cup, 24 mg magnesium per cup, 222 mg phosphorus per cup, 349 mg potassium per cup, 0.44 mg riboflavin per cup, and 1.1 mcg vitamin B12 per cup, in accordance with fortification guidelines issued by FDA. Juice Must be pasteurized 100% unsweetened fruit juice. Must conform to FDA standard of identity (21 CFR part 146) or vegetable juice must conform to FDA standard of identity (21 CFR part 156) and contain at least 30 mg of vitamin C per 100 mL of juice. With the exception of 100 percent citrus juices, State agencies must verify the vitamin C content of all State-approved juices. Juices that are fortified with other nutrients may be allowed at the State agency's option. Juice may be fresh, from concentrate, frozen, canned, or shelf-stable. Vegetable juice may be regular or lower in sodium. 3 Eggs Fresh shell domestic hens' eggs or dried eggs mix (must conform to FDA standard of identity in 21 CFR 160.105) or pasteurized liquid whole eggs (must conform to FDA standard of identity in 21 CFR 160.115). Hard boiled eggs, where readily available for purchase in small quantities, may be provided for homeless participants. Breakfast cereal Breakfast cereals as defined by FDA in 21 CFR 170.3(n)(4) for ready-to-eat and instant and regular hot cereals. Must contain a minimum of 28 mg iron per 100 g dry cereal. Must contain ≤ 21.2 g sucrose and other sugars per 100 g dry cereal (≤ 6 g per dry oz). At least half of the cereals authorized on a State agency's food list must have whole grain as the primary ingredient by weight AND meet labeling requirements for making a health claim as a “whole grain food with moderate fat content”: 4

(1)Contain a minimum of 51% whole grains (using dietary fiber as the indicator);

(2)Meet the regulatory definitions for “low saturated fat” at 21 CFR 101.62 (≤ 1 g saturated fat per RACC) and “low cholesterol” (≤ 20 mg cholesterol per RACC);

(3)Bear quantitative trans fat labeling; and

(4)Contain ≤ 6.5 g total fat per RACC and ≤ 0.5 g trans fat per RACC. Fruits and Vegetables (fresh and processed) Any variety of fresh whole or cut fruit without added sugars. 5 Any variety of fresh whole or cut vegetable, except white potatoes, without added sugars, fats, or oils (orange yams and sweet potatoes are allowed). 5 Any variety of canned 6 fruits (must conform to FDA standard of identity (21 CFR part 145); including applesauce, juice pack or water pack without added sugars, fats, oils, or salt (i.e. sodium). Any variety of frozen fruits without added sugars. 7 Any variety of canned 6 or frozen vegetables (must conform to FDA standard of identity (21 CFR part 155)) except white potatoes (orange yams and sweet potatoes are allowed); without added sugars, fats, or oils. May be regular or lower in sodium. 3 7 Any type of dried fruits or dried vegetable without added sugars, fats, oils, or salt (i.e., sodium). 5 Whole wheat bread/Whole grain bread/Other whole unprocessed grains *Bread* *Whole wheat bread* must conform to FDA standard of identity (21 CFR 136.180). (Includes whole wheat buns and rolls.) AND Whole wheat must be the primary ingredient by weight in all whole wheat bread products. *Whole grain bread* must meet labeling requirements for making a health claim as a “whole grain food with moderate fat content”: 4

(1)Contain a minimum of 51% whole grains (using dietary fiber as the indicator);

(2)Meet the regulatory definitions for “low saturated fat” at 21 CFR 101.62 (≤ 1 g saturated fat per RACC) and “low cholesterol” (≤ 20 mg cholesterol per RACC);

(3)Bear quantitative trans fat labeling; and

(4)Contain ≤ 6.5 g total fat per RACC and ≤ 0.5 g trans fat per RACC. AND Whole grain must be the primary ingredient by weight in all whole grain bread products. *Other Whole Unprocessed Grains* Brown rice, bulgur (cracked wheat), oatmeal, and whole-grain barley without added sugars, fats, oils, or salt (i.e., sodium). May be instant-, quick-, or regular-cooking. Soft corn or whole wheat tortillas may be allowed at the State agency's option. Whole grain must be the primary ingredient by weight. Canned fish 6 Canned only: Light tuna (must conform to FDA standard of identity (21 CFR 161.190)); Salmon (must conform to FDA standard of identity (21 CFR 161.170)); Sardines; Mackerel (N. Atlantic Scomber scombrus, or Chub Pacific Scomber japonicus); May be packed in water or oil. Pack may include bones or skin. May be regular or lower in sodium content. 3 Mature legumes (dry beans and peas) Any type of mature dry beans, peas, or lentils in dry-packaged or canned 6 forms. Examples include but are not limited to black beans (“turtle beans”), blackeye peas (cowpeas of the blackeye variety, “cow beans”), garbanzo beans (chickpeas), great northern beans, kidney beans, lima beans (“butter beans”), navy beans, pinto beans, soybeans, split peas, and lentils. All categories exclude soups. May not contain added sugars, fats, oils or meat as purchased. Canned legumes may be regular or lower in sodium content. 3 8 Baked beans may be provided for participants with limited cooking facilities. 8 Peanut butter Peanut butter and reduced fat peanut butter (must conform to FDA Standard of Identity (21 CFR 164.150)); creamy or chunky, regular or reduced fat, salted or unsalted 3 forms are allowed. Infant Foods: Infant cereal Infant cereal must contain a minimum of 45 mg of iron per 100 g of dry cereal. 9 Infant fruits Any variety of single ingredient commercial infant food fruit without added sugars, starches, or salt (i.e., sodium). Texture may range from strained through diced. 10 Infant vegetables Any variety of single ingredient commercial infant food vegetables without added sugars, starches, or salt (i.e., sodium). Texture may range from strained through diced. 11 Infant meat Any variety of commercial infant food meat or poultry, as a single major ingredient, with added broth or gravy. Added sugars or salt (i.e. sodium) are not allowed. Texture may range from pureed through diced. 12 Table 4 Footnotes: FDA = Food and Drug Administration of the U.S. Department of Health and Human Services; RACC = reference amount customarily consumed. 1 The following are not considered a WIC eligible medical food: Formulas used solely for the purpose of enhancing nutrient intake, managing body weight, addressing picky eaters or used for a condition other than a qualifying condition (e.g., vitamin pills, weight control products, etc.); medicines or drugs, as defined by the Food, Drug and Cosmetic Act (21 U.S.C. 350a) as amended; enzymes, herbs, or botanicals; oral rehydration fluids or electrolyte solutions; flavoring or thickening agents; and feeding utensils or devices (e.g., feeding tubes, bags, pumps) designed to administer a WIC-eligible formula. 2 All authorized milks must confirm to FDA, DHHS standards of identity for milks as defined by 21 CFR part 131 and meet WIC's requirements for vitamin fortification as stated above. Additional authorized milks include, but are not limited to: calcium-fortified, lactose-reduced and lactose-free, acidified, and UHT pasteurized milks. Other milks are permitted at the State agency's discretion provided that the State agency determines that the milk meets the minimum requirements for authorized milk. 3 Any of the folowing lower sodium forms are allowable: *Sodium-free* —less than 5 mg sodium per serving; *Very low sodium* —35 mg sodium or less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 35 mg sodium or less per 50 g of the food; *Low-sodium* —140 mg sodium or less per serving or, if the serving is 30 g or less or 2 tablespoons or less, 140 mg sodium or less per 50 g of the food; *Light in sodium* —at least 50 percent less sodium per serving than average reference amount for same food with no sodium reduction; *Lightly salted* —at least 50 percent less sodium per serving than reference amount (If the food is not “low in sodium,” the statement “not a low-sodium food” must appear on the same panel as the Nutrition Facts panel.); and *Reduced or less sodium* —at least 25 percent less sodium per serving than reference food. 4 Food and Drug Administration (FDA), *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at * http://www.cfsan.fda.gov/~dms/flgrain2.html* 5 Herbs or spices; edible blossoms and flowers, e.g., squash blossoms (broccoli, cauliflower and artichokes are allowed); creamed or sauced vegetables; vegetable-grain (pasta or rice) mixtures; fruit-nut mixtures; breaded vegetables; fruits and vegetables for purchase on salad bars; peanuts; ornamental and decorative fruits and vegetables such as chili peppers on a string; garlic on a string; gourds; painted pumpkins; fruit baskets and party vegetable trays; and items such as blueberry muffins and other baked goods are not authorized. Mature legumes (dry beans and peas) and juices are provided as separate food WIC categories and are not authorized under the fruit and vegetable category. 6 “Canned” refers to processed food items in cans or other shelf-stable containers, e.g., jars, pouches. 7 Excludes white potatoes; catsup or other condiments; pickled vegetables, olives; soups; juices; and fruit leathers and fruit roll-ups. 8 The following canned mature legumes are not authorized: soups; immature varieties of legumes, such as those used in canned green peas, green beans, snap beans, orange beans, and wax beans; baked beans with meat; e.g., beans and franks; and beans containing added sugars (with the exception of baked beans), fats, meat, or oils. 9 Infant cereals containing infant formula, milk, fruit, or other non-cereal ingredients are not allowed. 10 Mixtures with cereal or infant food desserts (e.g., peach cobbler) are not authorized; however, combinations of single ingredients (e.g., apple-banana) are allowed. 11 Combinations of single ingredients (e.g., peas and carrots) are allowed. 12 No infant food combinations (e.g., meat and vegetables) or dinners (e.g., spaghetti and meatballs) are allowed.

(f)*USDA purchase of commodity foods* .

(1)At the request of a State agency, FNS may purchase commodity foods for the State agency using funds allocated to the State agency. The commodity foods purchased and made available to the State agency must be equivalent to the foods specified in Table 4 of paragraph (e)(12) of this section.

(2)The State agency must:

(i)Distribute the commodity foods to its local agencies or participants; and

(ii)Ensure satisfactory storage facilities and conditions for the commodity foods, including documentation of proper insurance.

(g)*Infant formula manufacturer registration* . Infant formula manufacturers supplying formula to the WIC Program must be registered with the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Such manufacturers wishing to bid for a State contract to supply infant formula to the program must certify with the State health department that their formulas comply with the Federal Food, Drug, and Cosmetic Act and regulations issued pursuant to the Act.

(h)*Rounding up* . State agencies may round up to the next whole container for either infant formula or infant foods (infant cereal, fruits, vegetables and meat). State agencies that use the rounding up option must calculate the amount of infant formula or infant foods provided according to the requirements and methodology as described in this section.

(1)*Infant Formula* . State agencies must use the maximum monthly allowance of reconstituted fluid ounces of liquid concentrate infant formula as specified in Table 1 of paragraph (e)(9) of this section as the full nutritional benefit

(FNB)provided by infant formula for each food package category and infant feeding option (e.g., Food Package I A fully formula fed, IA-FF).

(i)For State agencies that use rounding up of infant formula, the FNB is determined over the timeframe (the number of months) that the participant receives the food package. In any given month of the timeframe, the monthly issuance of reconstituted fluid ounces of infant formula may exceed the maximum monthly allowance or fall below the FNB; however, the cumulative average over the timeframe may not fall below the FNB. In addition, the State agency must:

(A)Use the methodology described in paragraph (h)(1)(ii) of this section for calculating and dispersing the rounding up option;

(B)Issue infant formula in whole containers that are all the same size; and

(C)Disperse the number of whole containers as evenly as possible over the timeframe with the largest monthly issuances given in the beginning of the timeframe.

(ii)The methodology to calculate rounding up and dispersing infant formula to the next whole container over the food package timeframe is as follows:

(A)Multiply the FNB amount for the appropriate food package and feeding option (e.g. Food Package I A fully formula fed, IA-FF) by the timeframe the participant will receive the food package to determine the total amount of infant formula to be provided.

(B)Divide the total amount of infant formula to be provided by the yield of the container (in reconstituted fluid ounces) issued by the State agency to determine the total number of containers to be issued during the timeframe that the food package is prescribed.

(C)If the number of containers to be issued does not result in a whole number of containers, the State agency must round up to the next whole container in order to issue whole containers.

(2)*Infant foods* .

(i)State agencies may use the rounding up option to the next whole container of infant food (infant cereal, fruits, vegetables and meats) when the maximum monthly allowance cannot be issued due to varying container sizes of authorized infant foods.

(ii)State agencies that use the rounding up option for infant foods must:

(A)Use the methodology described in paragraph (h)(2)(iii) of this section for calculating and dispersing the rounding up option;

(B)Issue infant foods in whole containers; and

(C)Disperse the number of whole containers as evenly as possible over the timeframe (the number of months the participant will receive the food package).

(iii)The methodology to round up and disperse infant food is as follows:

(A)Multiply the maximum monthly allowance for the infant food by the timeframe the participant will receive the food package to determine the total amount of food to be provided.

(B)Divide the total amount of food provided by the container size issued by the State agency (e.g., ounces) to determine the total number of food containers to be issued during the timeframe that the food package is prescribed.

(C)If the number of containers to be issued does not result in a whole number of containers, the State agency must round up to the next whole container in order to issue whole containers.

(i)*Plans for substitutions* .

(1)The State agency may submit to FNS a plan for substitution of food(s) acceptable for use in the Program to allow for different cultural eating patterns. The plan shall provide the State agency's justification, including a specific explanation of the cultural eating pattern and other information necessary for FNS to evaluate the plan as specified in paragraph (i)(2) of this section.

(2)FNS will evaluate a State agency's plan for substitution of foods for different cultural eating patterns based on the following criteria:

(i)Any proposed substitute food must be nutritionally equivalent or superior to the food it is intended to replace.

(ii)The proposed substitute food must be widely available to participants in the areas where the substitute is intended to be used.

(iii)The cost of the substitute food must be equivalent to or less than the cost of the food it is intended to replace.

(3)FNS will make a determination on the proposed plan based on the evaluation criteria specified in paragraph (i)(2) of this section, as appropriate. The State agency shall substitute foods only after receiving the written approval of FNS. 6. In § 246.12: a. Revise the second sentence of paragraph (a)(1). b. Amend paragraphs (e), (f)(2)(i), (f)(2)(ii), (f)(2)(iv), (h)(3)(ix), (k)(2), and (k)(3), by removing the words “food instrument” wherever they appear and adding in their place the words “food instrument or cash-value voucher”; c. Amend paragraphs (h)(3)(i), (h)(3)(xv), and (i)(2), by removing the words “food instruments” wherever they appear and adding in their place the words “food instruments and cash-value vouchers”; d. Amend paragraphs (l)(1)(i), (l)(1)(ii)(B), (l)(1)(iii)(A), (l)(1)(iii)(D), and (l)(1)(iii)(F), by removing the words “food instruments” wherever they appear and adding in their place the words “food instruments or cash-value vouchers”; e. Revise the heading of paragraph (f), paragraph (f)(1), paragraph (f)(2) introductory text, paragraphs (f)(2)(iii), (f)(3), (g)(3)(i), (h)(3)(ii), and (h)(3)(iv) through (h)(3)(vi), (h)(3)(x), and paragraphs (k)(1), (k)(5), and

(o)through (s); f. Amend paragraph

(t)by removing the word “vendor” and adding in its place the words “vendor, farmer”; and g. Add a new paragraph (v). The addition and revisions read as follows: § 246.12 Food delivery systems.

(a)* * *

(1)* * * The State agency may permit only authorized vendors and farmers, home food delivery contractors, and direct distribution sites to accept food instruments and cash-value vouchers.

(f)*Retail food delivery systems: Food instrument and cash-value voucher requirements* —(1) *General.* State agencies using retail food delivery systems must use food instruments and cash-value vouchers that comply with the requirements of paragraph (f)(2) of this section.

(2)*Printed food instruments and cash-value vouchers.* Each printed food instrument and cash-value voucher must clearly bear on its face the following information:

(iii)*Last date of use.* The last date on which the food instrument or cash-value vouchers may be used to obtain authorized supplemental foods. This date must be a minimum of 30 days from the first date on which it may be used, except for the participant's first month of issuance, when it may be the end of the month or cycle for which the food instrument or cash-value voucher is valid. Rather than entering a specific last date of use on each instrument or cash-value voucher, all instruments or cash-value vouchers may be printed with a notice that the participant must transact them within a specified number of days after the first date on which the food instrument or cash-value voucher may be used;

(3)*Vendor identification.* The State agency must implement procedures to ensure each food instrument and cash-value voucher submitted for redemption can be identified by the vendor or farmer that submitted the food instrument or cash-value voucher. Each vendor operated by a single business entity must be identified separately. The State agency may identify vendors by requiring that all authorized vendors stamp their names and/or enter a vendor identification number on all food instruments or cash-value vouchers prior to submitting them for redemption.

(g)* * *

(3)* * *

(i)*Minimum variety and quantity of supplemental foods.* The State agency must establish minimum requirements for the variety and quantity of supplemental foods that a vendor applicant must stock to be authorized. These requirements include that the vendor stock at least two varieties of fruits, two varieties of vegetables, and at least one whole grain cereal authorized by the State agency. The State agency may not authorize a vendor applicant unless it determines that the vendor applicant meets these minimums. The State agency may establish different minimums for different vendor peer groups.

(h)* * *

(3)* * *

(ii)*No substitutions, cash, credit, refunds, or exchanges.* The vendor may provide only the authorized supplemental foods listed on the food instrument and cash-value voucher. The vendor may not provide unauthorized food items, non-food items, cash, or credit (including rainchecks) in exchange for food instruments or cash-value vouchers. The vendor may not provide refunds or permit exchanges for authorized supplemental foods obtained with food instruments or cash-value vouchers, except for exchanges of an identical authorized supplemental food item when the original authorized supplemental food item is defective, spoiled, or has exceeded its “sell by,” “best if used by,” or other date limiting the sale or use of the food item. An identical authorized supplemental food item means the exact brand and size as the original authorized supplemental food item obtained and returned by the participant.

(iv)*Time periods for transacting food instruments and cash-value vouchers.* The vendor may accept a food instrument or cash-value voucher only within the specified time period.

(v)*Purchase price on food instruments and cash-value vouchers.* The vendor must ensure that the purchase price is entered on food instruments and cash-value vouchers in accordance with the procedures described in the vendor agreement. The State agency has the discretion to determine whether the vendor or the participant enters the purchase price. The purchase price must include only the authorized supplemental food items actually provided and must be entered on the food instrument or cash-value voucher before it is signed.

(vi)*Signature on food instruments and cash-value vouchers.* For printed food instruments and cash-value vouchers, the vendor must ensure the participant, parent or caretaker of an infant or child participant, or proxy signs the food instrument or cash-value voucher in the presence of the cashier. In EBT systems, a Personal Identification Number

(PIN)may be used in lieu of a signature.

(x)*No charge for authorized supplemental foods or restitution from participants.* The vendor may not charge participants, parents or caretakers of infant and child participants, or proxies for authorized supplemental foods obtained with food instruments or cash-value vouchers. In addition, the vendor may not seek restitution from these individuals for food instruments or cash-value vouchers not paid or partially paid by the State agency. The State agency may, however, allow participants, parents or caretakers of child participants to pay the difference when the purchase of authorized fruits and vegetables exceeds the value of the cash-value voucher.

(k)* * *

(1)*System to review food instruments and cash-value vouchers for vendor claims.* The State agency must design and implement a system to review food instruments and cash-value vouchers submitted by vendors for redemption to ensure compliance with the applicable price limitations and to detect questionable food instruments or cash-value vouchers, suspected vendor overcharges, and other errors. This review must examine either all or a representative sample of the food instruments and cash-value vouchers and may be done either before or after the State agency makes payments on the food instruments or cash-value vouchers. The review of food instruments must include a price comparison or other edit designed to ensure compliance with the applicable price limitations and to assist in detecting vendor overcharges. For printed food instruments and cash-value vouchers the system also must detect the following errors—purchase price missing; participant, parent/caretaker, or proxy signature missing; vendor identification missing; food instruments or cash-value vouchers transacted or redeemed after the specified time periods; and, as appropriate, altered purchase price. The State agency must take follow-up action within 120 days of detecting any questionable food instruments or cash-value vouchers, suspected vendor overcharges, and other errors and must implement procedures to reduce the number of errors when possible.

(5)*Food instruments and cash-value vouchers redeemed after the specified period.* With justification and documentation, the State agency may pay vendors for food instruments and cash-value vouchers submitted for redemption after the specified period for redemption. If the total value of such food instruments or cash-value vouchers submitted at one time exceeds $500.00, the State agency must obtain the approval of the FNS Regional Office before payment.

(o)*Participant, parent/caretaker, proxy, vendor, farmer and home food delivery contractor complaints.* The State agency must have procedures to document the handling of complaints by participants, parents or caretakers of infant or child participants, proxies, vendors, farmers, home food delivery contractors, and direct distribution contractors. Complaints of civil rights discrimination must be handled in accordance with § 246.8(b).

(p)*Food instrument and cash-value voucher security.* The State agency must develop standards for ensuring the security of food instruments and cash-value vouchers from the time the food instruments and cash-value vouchers are created to the time they are issued to participants, parents/caretakers, or proxies. For pre-printed food instruments or cash-value vouchers, these standards must include maintenance of perpetual inventory records of food instruments or cash-value vouchers throughout the State agency's jurisdiction; monthly physical inventory of food instruments or cash-value vouchers on hand throughout the State agency's jurisdiction; reconciliation of perpetual and physical inventories of food instruments and cash-value vouchers; and maintenance of all food instruments and cash-value vouchers under lock and key, except for supplies needed for immediate use. For EBT and print-on-demand food instruments and cash-value vouchers, the standards must provide for the accountability and security of the means to manufacture and issue such food instruments and cash-value vouchers.

(q)*Food instrument and cash-value voucher disposition.* The State agency must account for the disposition of all food instruments and cash-value vouchers as either issued or voided, and as either redeemed or unredeemed. Redeemed food instruments and cash-value vouchers must be identified as validly issued, lost, stolen, expired, duplicate, or not matching valid enrollment and issuance records. In an EBT system, evidence of matching redeemed food instruments to valid enrollment and issuance records may be satisfied through the linking of the Primary Account Number

(PAN)associated with the electronic transaction to valid enrollment and issuance records. This process must be performed within 120 days of the first valid date for participant use of the food instruments and must be conducted in accordance with the financial management requirements of § 246.13. The State agency will be subject to claims as outlined in § 246.23(a)(4) for redeemed food instruments or cash-value vouchers that do not meet the conditions established in paragraph

(q)of this section.

(r)*Issuance of food instruments, cash-value vouchers and authorized supplemental foods.* The State agency must:

(1)*Parents/caretakers and proxies.* Establish uniform procedures that allow parents and caretakers of infant and child participants and proxies to obtain and transact food instruments and cash-value vouchers or obtain authorized supplemental foods on behalf of a participant. In determining whether a particular participant or parent/caretaker should be allowed to designate a proxy or proxies, the State agency must require the local agency or clinic to consider whether adequate measures can be implemented to provide nutrition education and health care referrals to that participant or, in the case of an infant or child participant, to the participant's parent or caretaker;

(2)*Signature requirement.* Ensure that the participant, parent or caretaker of an infant or child participant, or proxy signs for receipt of food instruments, cash-value vouchers or authorized supplemental foods, except as provided in paragraph (r)(4) of this section;

(3)*Instructions.* Ensure that participants, parents or caretakers of infant and child participants, and proxies receive instructions on the proper use of food instruments and cash-value vouchers, or on the procedures for obtaining authorized supplemental foods when food instruments or cash-value vouchers are not used. The State agency must also ensure that participants, parents or caretakers of infant and child participants, and proxies are notified that they have the right to complain about improper vendor, farmer and home food delivery contractor practices with regard to program responsibilities;

(4)*Food instrument and cash-value voucher pick up.* Require participants, parents and caretakers of infant and child participants, and proxies to pick up food instruments and cash-value vouchers in person when scheduled for nutrition education or for an appointment to determine whether participants are eligible for a second or subsequent certification period. However, in all other circumstances the State agency may provide for issuance through an alternative means such as EBT or mailing, unless FNS determines that such actions would jeopardize the integrity of program services or program accountability. If a State agency opts to mail food instruments and cash-value vouchers, it must provide justification, as part of its alternative issuance system in its State Plan, as required in § 246.4(a)(21), for mailing food instruments and cash-value voucher to areas where food stamps are not mailed. State agencies that opt to mail food instruments and cash-value vouchers must establish and implement a system that ensures the return of food instruments and cash-value vouchers to the State or local agency if a participant no longer resides or receives mail at the address to which the food instruments and cash-value vouchers were mailed; and

(5)*Maximum issuance of food instruments and cash-value voucher.* Ensure that no more than a three-month supply of food instruments and cash-value vouchers or a one-month supply of authorized supplemental foods is issued at any one time to any participant, parent or caretaker of an infant or child participant, or proxy.

(s)*Payment to vendors, farmers and home food delivery contractors.* The State agency must ensure that vendors, farmers and home food delivery contractors are paid promptly. Payment must be made within 60 days after valid food instruments or cash-value vouchers are submitted for redemption. Actual payment to vendors, farmers and home food delivery contractors may be made by local agencies.

(v)*Farmers.* The State agency may authorize farmers at farmers markets (or roadside stands) to accept the cash-value voucher for eligible fruits and vegetables. The State agency must enter into written agreements with all authorized farmers. The agreement must be signed by a representative who has legal authority to obligate the farmer and a representative of the State agency. The agreement must be for a period not to exceed three years. Only farmers authorized by the State agency may redeem the fruit and vegetable cash-value voucher. The State agency must require farmers to reapply at the expiration of their agreements and must provide farmers with not less than 15 days advance written notice of the expiration of the agreement.

(1)The agreement must include the following provisions, although the State agency may determine the exact wording. The farmer must:

(i)Assure that the cash-value voucher is redeemed only for eligible fruits and vegetables as defined by the State agency;

(ii)Provide eligible fruits and vegetables at the current price or less than the current price charged to other customers;

(iii)Accept the cash-value voucher within the dates of their validity and submit such vouchers for payment within the allowable time period established by the State agency;

(iv)Redeem the cash-value voucher in accordance with a procedure established by the State agency,

(v)Accept training on cash-value voucher procedures and provide training to any employees with cash-value voucher responsibilities on such procedures;

(vi)Agree to be monitored for compliance with program requirements, including both overt and covert monitoring;

(vii)Be accountable for actions of employees in the provision of authorized foods and related activities;

(viii)Pay the State agency for any cash-value vouchers transacted in violation of this agreement;

(ix)Offer WIC participants, parent or caretakers of child participants or proxies the same courtesies as other customers;

(x)Comply with the nondiscrimination provisions of USDA regulations as provided in § 248.7; and

(xi)Notify the State agency if any farmers' market ceases operation prior to the end of the authorization period.

(2)The farmer must not:

(i)Collect sales tax on cash-value voucher purchases;

(ii)Seek restitution from WIC participants, parent or caretakers of child participants or proxies for cash-value vouchers not paid or partially paid by the State agency;

(iii)Issue cash change for purchases that are in an amount less than the value of the cash-value voucher;

(3)Neither the State agency nor the farmer has an obligation to renew the agreement. Either the State agency or the farmer may terminate the agreement for cause after providing advance written notification.

(4)The State agency may deny payment to the farmer for improperly redeemed cash-value vouchers and may demand refunds for payments already made on improperly redeemed vouchers.

(5)The State agency may disqualify a farmer for WIC Program abuse. The farmer has the right to appeal a denial of an application to participate, a disqualification, or a program sanction by the State agency. Expiration of an agreement with a farmer and claims actions under § 246.23, are not appealable.

(6)A farmer which commits fraud or engages in other illegal activity is liable to prosecution under applicable Federal, State or local laws. 7. In § 246.16, add a new paragraph

(j)to read as follows: § 246.16 Distribution of funds.

(j)*Inflation adjustment of the fruit and vegetable voucher.* The monthly cash value of the fruit and vegetable voucher shall be adjusted annually for inflation. Adjustments are effective the first day of each fiscal year beginning on or after October 1, 2008. The inflation-adjusted value of the voucher shall be equal to a base value increased by a factor based on the Consumer Price Index for fresh fruits and vegetables, as provided in this section.

(1)*Adjustment year.* The adjustment year is the fiscal year that begins October 1 of the current calendar year.

(2)*Base value of the fruit and vegetable voucher.* The base value of the fruit and vegetable voucher is the monthly cash value of the voucher for fiscal year 2008. The base value equals:

(i)$6 for children;

(ii)$8 for pregnant and postpartum women; and

(iii)$10 for breastfeeding women.

(3)*Adjusted value of the fruit and vegetable voucher.* The adjusted value of the fruit and vegetable voucher is the cash value of the voucher for adjustment years beginning on or after October 1, 2008. The adjusted value is the base value increased by an amount equal to the base value of the fruit and vegetable voucher:

(i)Multiplied by the inflation adjustment described in paragraph (j)(4) of this section; and

(ii)Subject to rounding as described in paragraph (j)(5) of this section.

(4)*Inflation adjustment.* The inflation adjustment of the fruit and vegetable voucher shall equal the percentage (if any) by which the annual average value of the Consumer Price Index for fresh fruits and vegetables, computed from monthly values published by the Bureau of Labor Statistics, for the twelve months ending on March 31 of the fiscal year immediately prior to the adjustment year, exceeds the average of the monthly values of that index for the twelve months ending on March 31, 2007.

(5)*Rounding.* If any increase in the cash value of the voucher determined under paragraph (j)(3) of this section is not a multiple of $1, such increase shall be rounded to the next lowest multiple of $1. However, if the adjusted value of the voucher for the adjustment year, as determined under paragraph (j)(3) of this section, is lower than the adjusted value for the fiscal year immediately prior to the adjustment year, then the adjusted value of the voucher will remain unchanged from that immediate prior fiscal year. 8. In § 246.18: a. Amend paragraph (a)(1)(iii)(G) by removing the words “food instrument” and adding in their place the words “food instrument or cash-value voucher”; b. Add a new paragraph (a)(4); c. Revise the introductory text of paragraph (b); d. Amend paragraph

(d)by removing the words “local agency or a vendor” and adding in their place the words “local agency, farmer or vendor”; e. Amend paragraph

(e)by removing the words “vendor or the local agency” and adding in their place the words “vendor, farmer or local agency”; and f. Amend paragraph

(f)by removing the words “vendor or local agency” wherever they appear and adding in their place the words “vendor, farmer or local agency”. The addition and revision read as follows: § 246.18 Administrative review of State agency actions.

(a)* * *

(4)*Farmer appeals* —(i) *Adverse Actions.* The State agency shall provide a hearing procedure whereby farmers adversely affected by certain actions of the State agency may appeal those actions. A farmer may appeal an action of the State agency denying its application to participate, imposing a sanction, or disqualifying it from participation in the program. Expiration of an agreement is not subject to appeal.

(ii)*Effective date of adverse actions against farmers.* The State agency must make denials of authorization and disqualifications effective on the date of receipt of the notice of adverse action. The State agency must make all other adverse actions effective no earlier than 15 days after the date of the notice of the adverse action and no later than 90 days after the date of the notice of adverse action or, in the case of an adverse action that is subject to administrative review, no later than the date the farmer receives the review decision.

(b)*Full administrative review procedures.* The State agency must develop procedures for a full administrative review of the adverse actions listed in paragraphs (a)(1)(i), (a)(3) and (a)(4) of this section. At a minimum, these procedures must provide the vendor, farmer or local agency with the following: 9. In § 246.23, revise paragraph (a)(4) to read as follows: § 246.23 Claims and penalties.

(a)* * *

(4)FNS will establish a claim against any State agency that has not accounted for the disposition of all redeemed food instruments and cash-value vouchers and taken appropriate follow-up action on all redeemed food instruments and cash-value vouchers that cannot be matched against valid enrollment and issuance records, including cases that may involve fraud, unless the State agency has demonstrated to the satisfaction of FNS that it has:

(i)Made every reasonable effort to comply with this requirement;

(ii)Identified the reasons for its inability to account for the disposition of each redeemed food instrument or cash-value voucher; and

(iii)Provided assurances that, to the extent considered necessary by FNS, it will take appropriate actions to improve its procedures. Dated: November 21, 2007. Nancy Montanez Johner, Under Secretary for Food, Nutrition and Consumer Services. Appendix Note: This appendix will not be published in the Code of Federal Regulations. Regulatory Impact Analysis 7 CFR Part 246: Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages Interim Rule Executive Summary The WIC program addresses the supplemental nutritional needs of at-risk groups through the distribution of supplemental food packages, and a program of nutrition education that includes counseling, health and social service referrals, and breastfeeding promotion and support. WIC nutrition education provisions are governed by broad regulatory language that allows nutrition education provided to participants to respond to the supplemental nutrition needs of participants in light of changes in dietary and health research. In contrast, WIC supplemental food packages are defined very specifically in regulatory language. Consequently, as the population served by WIC has grown and become more diverse over the last 27 years and as food consumption habits have changed, the nutritional risks faced by participants have changed. Also, though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. The interim rule modifies regulations governing the WIC food packages to implement recommended changes based on the current supplemental nutritional needs of WIC participants and advances in nutrition science. Specifically, the interim rule: revises the maximum monthly allowances and minimum requirements for certain supplemental foods; revises the substitution rates for certain supplemental foods and allows additional foods as alternatives; revises age specifications for assignment to infant food packages; modifies food packages to promote breastfeeding; adds foods to children and women food packages; and, addresses general provisions that apply to all food packages. The revisions reflect recommendations made by the Institute of Medicine of the National Academies in its Report *WIC Food Packages: Time for a Change,* comments received on the Proposed Rule published in the **Federal Register** on August 7, 2006 (71 FR 44784), and certain administrative revisions found necessary by the Department. The revisions also bring the WIC food packages in line with the 2005 Dietary Guidelines for Americans and current infant feeding practice guidelines of the American Academy of Pediatrics to: better promote and support the establishment of successful long-term breastfeeding; provide WIC participants with a wider variety of food; provide WIC State agencies with greater flexibility in prescribing food packages to accommodate participants with cultural food preferences; and, serve all participants with certain medical provisions under one food package to facilitate efficient management of participants with special dietary needs. This impact analysis specifically addresses significant or substantial public comments and Department modifications from the provisions as initially proposed in the Proposed Rule. Unless otherwise stated, the provisions stated in the impact analysis for the Proposed Rule should be regarded as the basis for the impact analysis of the interim rule. Under the interim rule, revisions to the WIC food packages are cost-neutral to the Federal Government. Specifically, FNS estimates that the changes will decrease costs by $29.7 million over five years, a negligible amount relative to the program's annual cost of more than $5 billion. While the additional program costs from the rule change are negligible, the changes in food packages that will result represent important improvements in the program's alignment with current dietary guidance, increase the variety and appropriateness of foods provided to clients, and better promote healthy eating behaviors. These benefits will improve the program relative to current rules for years to come. Table of Contents Action Nature Need Affected Parties Effects Background Summary of Rule and Benefits Food Package I Food Package II Food Package III Food Package IV Food Package V Food Package VI Food Package VII Other Provisions Summary of Key Provisions Costs Interim Rule Major Cost Drivers Fruit and Vegetables Option Cost Estimate Methodology Overview Food Package Costs Prescriptions Infant Formula and Rounding Redemption Rates Food Prices Participant Projections Phased Implementation State Cost Variation Administrative Costs Uncertainties Price Volatility in the Dairy Market Assumed Preference for Soy Beverage State Option to Provide Formula for Infants 0-0.9 Months of Age Prescription Assumptions for Whole Grain Bread and Bread substitutes Prescription Assumptions for Infant Food Fruits, Vegetables, and Meat Changes in Current Food Package Sizes Uncertainties Summary Alternatives Include Yogurt as a Milk Substitute for Food Packages IV-VII Increase the Whole Grain Maximum Allowance Fresh Fruit and Vegetables for Infants Soy Beverage Substitution for Children without Medical Documentation Market Share Analysis Appendix A: Additional Cost Estimate Assumptions *Date:* November 5, 2007. *Agency:* USDA, Food and Nutrition Service. *Contact:* Ed Herzog. *Phone:*

(703)305-2340. *Fax:*

(703)305-2576. *E-mail:* *edward.herzog@fns.usda.gov* . *Title:* 7 CFR Part 246: Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages. Action A. Nature: Interim Rule. B. Need: The WIC program addresses the supplemental nutritional needs of at-risk groups through the distribution of age and condition specific food packages, and a program of nutrition education that includes counseling, health and social service referrals, and breastfeeding promotion and support. WIC nutrition education provisions are governed by broad regulatory language that allows nutrition education provided to participants to respond to changes in dietary and health research. In contrast, WIC supplemental food packages are defined very specifically in the regulatory language. Consequently, as the population served by WIC has grown and become more diverse over the last 27 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages have remained largely unchanged. This rule is needed to implement recommended changes to the WIC food packages based on the current supplemental nutritional needs of WIC participants and advances in nutrition science. C. Affected Parties: The program affected by this rule is the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). The parties affected by this regulation are the USDA's Food and Nutrition Service (FNS), State and local agencies that administer the WIC Program, retail vendors, food producers and manufacturers, and WIC participants. Effects The following analysis describes the potential economic impact of the interim rule. This rule is needed due to changes in the population served by WIC, and advances in nutrition and knowledge about the supplemental nutritional needs of those served by WIC. The changes in this rule are significant to the costs or overall operations to the program. The potential effects of these changes are highlighted below. A. Background The WIC program was established in the 1970s to address the special supplemental nutritional needs of low-income pregnant and postpartum women, infants, and children up to age five who are determined to be at nutritional risk. Regulations governing the WIC program recognize a broad range of nutritionally related medical conditions for purposes of establishing program eligibility. These include anemia, low birth weight, chronic infections, overweight, underweight, and similar manifestations of poor nutrition suitable for direct measurement or diagnosis. 1 WIC regulations also recognize that personal medical histories, dietary patterns, and economic circumstances may put otherwise healthy women or children at nutritional risk. Certification may therefore be extended to women facing high-risk pregnancies, pregnant women or mothers who abuse alcohol or drugs, homeless women and children, and infants and children with congenital malformations or other medical conditions that may interfere with adequate nutrient intake or absorption. 1 7 CFR 246.7(e). WIC addresses the supplemental nutritional needs of at-risk groups through the distribution of age- and condition-specific food packages, and a program of nutrition education that includes counseling, health and social service referrals, and breastfeeding promotion and support. Supplemental foods are currently offered to WIC participants in one of seven packages designed for the special supplemental nutritional needs of the following sub-populations: I. Infants under four months old II. Infants from four to twelve months old III. Children and women with special dietary needs IV. Children from one to five years old V. Pregnant and breastfeeding women VI. Non-breastfeeding postpartum women VII. Exclusively breastfeeding women Inadequate nutrition was the prime motivating factor behind the enactment of the WIC program. 2 Nutrition research in the 1970s pointed to calcium, iron, high quality protein, and vitamins A and C as nutrients most likely to be lacking in the diets of low-income women, infants, and children. Current WIC food packages reflect that early research. Today's packages include some combination of: iron-fortified infant formulas, iron-fortified cereals, vitamin C rich juice, vitamin A and D fortified milk, eggs, cheese, dried beans or peas, peanut butter, tuna, and carrots. Other factors that contributed to the selection of these foods are their nutrient density, modest cost, wide availability, and broad acceptance by the WIC-eligible population. 2 See 42 U.S.C. 1786(a). WIC's nutrition education provisions are governed by broad regulatory language that seeks to promote “proper nutrition,” “optimal use” of WIC's supplemental foods, and appropriate advice concerning non-WIC foods. 3 Compliance with this regulatory mandate presumes that nutrition education will respond to the supplemental nutrition needs of participants based on advances in dietary and health research. The U.S. Department of Agriculture's

(USDA)Food and Nutrition Service

(FNS)provides for provision of nutrition education to WIC participants that is consistent with the Dietary Guidelines for Americans. 3 7 CFR 246.11. The statute governing WIC directs the Secretary of Agriculture to prescribe supplemental food packages for the program. 4 As a result, the content of WIC food packages is defined with specificity in program regulations; the regulatory flexibility that characterizes WIC nutrition education does not extend to the prescription of individual food packages. The list of WIC-approved foods provides select, nutrient-rich foods; allowed substitutions provide only limited room for participant-specific food package tailoring. 4 42 U.S.C. 1786(b)(14). The population served by the WIC program has grown in size and diversity over time and the frequency of nutritional risks faced by WIC participants have changed. White and Black participants represented 72% of the WIC population in 1992; by 2004, just 56% of WIC participants fell into one of those two racial/ethnic groups. 5 WIC's Hispanic population, itself a diverse group, has grown from the third largest to the largest over the same period. Greater ethnic diversity increases the demand for additional food options consistent with cultural preferences. 5 U.S. Department of Agriculture, Food and Nutrition Service, Office of Analysis, Nutrition and Evaluation, WIC Participant and Program Characteristics 1992, Abt Associates. Alexandria, VA: 1994. U.S. Department of Agriculture, Food and Nutrition Service, Office of Analysis, Nutrition and Evaluation, WIC Participant and Program Characteristics 2004, Abt. Associates. Alexandria, VA: 2005. The program characteristics studies performed prior to 1992 did not include participant data from Alaska, Hawaii, Puerto Rico, or U.S. territories. The racial/ethnic breakdowns from those earlier reports should not be directly compared to the ones contained in reports from 1992 forward. In addition, the nutritional risks faced by the low-income population of the 1970s have changed. Although inadequate intake of some nutrients remains a concern, 6 improved diets have reduced the prevalence of once relatively common deficiency diseases and underweight in at-risk groups. A WIC program that now assists nearly eight million individuals monthly, including about half of the nation's infants, 7 supplements the diets of an at-risk population with the very types of iron-fortified, nutrient-dense foods associated with this changed health picture. WIC's current food packages, little modified since the 1970s, were appropriately designed to address the recognized nutritional priorities of that time. But today's WIC population, like the U.S. population as a whole, faces a reordered set of priorities. Excessive intakes of some nutrients, including saturated fat, and of food energy have taken a place among the nation's top public health concerns. 8 Other nutrients, including vitamin E, and fiber, have since been identified as lacking in the diets of WIC-eligible sub-populations. 9 While current WIC food packages continue to address important health risks of undernutrition, they do not target all identified inadequacies, and they may contribute to the risks associated with excessive intake of some nutrients. 6 National Academies, Institute of Medicine (IOM). *WIC Food Packages: Time for a Change,* Washington, DC: The National Academies Press, 2005. pp. 31, 64. 7 U.S. Department of Agriculture, Food and Nutrition Web site, July 2005. www.fns.usda.gov/wic/FAQs/FAQ.HTM. 8 See U.S. Department of Health and Human Services and U.S. Department of Agriculture, *Dietary Guidelines for Americans,* 2005, 6th edition, Washington DC: U.S. Government Printing Office, January 2005. (USDHHS/USDA, 2005) 9 IOM, p.59. Note, however, that these conclusions are based on self-reported food consumption data from the Continuing Survey of Food Intakes by Individuals (1994-1996 and 1998.) Underreporting of food intakes is suspected by women involved in the survey. And, the data do not include nutrients consumed in the form of dietary supplements. These factors may overstate the problem of nutrient inadequacies, and may understate the problem of excessive intakes. Medical consequences of improper diets include fetal or infant lead toxicity tied to low calcium intake by pregnant and breastfeeding women, birth defects caused by inadequate folate consumption early in pregnancy, iron-deficiency anemia, and heart disease, diabetes, stroke, and cancer, all linked to obesity and excessive intake of saturated fat. 10 Adjustments to the WIC food packages that move individual consumption of these priority nutrients closer to Recommended Dietary Allowances

(RDAs)and Adequate Intake

(AIs)levels of the Institute of Medicine's Dietary Reference Intakes may reduce the nutrition-related medical health risks of WIC participants. 10 See IOM, p. 63; see also “High Costs of Poor Eating Patterns in the United States,” Elizabeth Frazão, in *America's Eating Habits: Changes and Consequences,* Elizabeth Frazão, ed., Economic Research Service, U.S. Department of Agriculture, Washington, DC, 1999. B. Summary of Rule and Benefits FNS contracted with the National Academies' Institute of Medicine

(IOM)in 2003 to assess the nutritional health profile of the current WIC population, and to recommend changes in the content of the program's food packages. The Proposed Rule largely reflected recommendations made by the National Academies' Institute of Medicine

(IOM)in its Report *WIC Food Packages: Time for a Change,* with certain cost containment and administrative modification found necessary by the Department to ensure cost neutrality. The Proposed Rule detailed the first comprehensive revisions to the WIC food packages since 1980. The revised food packages were developed to better reflect current nutrition science and dietary recommendations than do current food packages, without impacting overall program costs. Compared to current WIC packages, the proposal: Provides greater consistency with the Dietary Guidelines for Americans. The interim rule adds fruits and vegetables, and whole grains to the packages for the first time. The revised packages include foods from each food group except oils and allow variety and choice within the groups. Reductions are made to the amounts provided for certain foods in the current packages in order to be more consistent with the amounts of these foods recommended in the 2005 Dietary Guidelines for Americans and WIC's role as a supplemental nutrition program. Supports improved nutrient intakes. The interim rule adds additional foods and modifies amounts of current foods support overall improvement in nutrient consumption and reduction in the prevalence of inadequate or excessive nutrient intakes. Compared with the current food packages, the revised packages are estimated to provide greater amounts of nearly all the nutrients identified by the IOM as often lacking in the diets of the WIC-eligible population, such as iron, fiber, and vitamin E. The revised food packages for women and children also provide less saturated fat, cholesterol, total fat and sodium than the current packages. Provides greater consistency with established dietary recommendations for infants and children under 2, including encouragement and support for breastfeeding. The revised infant food packages improve overall nutrient density compared to current packages while keeping caloric content the same or slightly lower. The revised packages change age specification for assignment as well as establish three feeding categories to better address current dietary recommendations of the American Academy of Pediatrics

(AAP)and promote breastfeeding. The packages for breastfeeding infant-mother pairs are revised to provide stronger incentives for continued breastfeeding, including providing less formula to partially breastfed infants than current packages, and providing additional quantities/types of food for breastfeeding mothers. For older infants, the proposal delays the introduction of complementary foods, consistent with AAP, from four to six months of age and modifies formula amounts. Infant foods are added and juice eliminated in the packages for older infants in order to promote healthy dietary patterns. Addresses Emerging Public Health Nutrition-Related Issues. The prevalence of overweight and obesity in adults, adolescents, and children have increased dramatically, with direct implications for WIC participants. For example, childhood overweight has been linked to adverse health outcomes including elevated blood pressure, hyperinsulinemia, glucose intolerance, type 2 diabetes, dyslipidemia, and other early risks for chronic disease. The addition of fruits and vegetables and the emphasis on whole grains are consistent with recommendations for food patterns that may contribute to a healthy body weight. Compared to the current food packages, the revised food packages provide less saturated fat and cholesterol than the current packages for women and children. In addition, the revised food packages are designed to encourage breastfeeding and thus may contribute to a reduced risk of overweight in children. Provides Wide Appeal to Diverse Populations. The proposed additional foods are the foods most often requested over the years by a variety of stakeholders such as the National WIC Association, WIC participants, WIC State and local agencies, industry and health professionals, and would provide more participant choice and a wider variety of foods than the current food packages. The increased variety and choice will provide State agencies increased flexibility in prescribing culturally appropriate food packages. The Proposed Rule was published in the **Federal Register** on August 7, 2006 (71 FR 44784), with a 90-day comment period. A total of 46,502 comment letters were received on the Proposed Rule; of those, 23,908 were form letters. Comments were submitted by a variety of stakeholders, including program participants, WIC State and local agencies and Indian Tribal Organizations, the National WIC Association, professional organizations and associations, advocacy groups, healthcare professionals (including universities), members of Congress, the food industry, vendors, farmers, and private citizens. With few changes, the provisions in the Proposed Rule have been adopted as this interim rule. This impact analysis specifically addresses significant or substantial public comments and Department modifications from the provisions as initially proposed. Unless otherwise stated, the provisions stated in the impact analysis for the Proposed Rule 11 should be regarded as the basis for the impact analysis of the interim rule. The provisions of the rule and the related changes are summarized below. 11 71 FR 44784: Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages: Proposed Rule, August 7, 2006, p. 44825. 1. Food Package I—Infants Under Six Months *Proposed rule: Tie maximum infant formula prescriptions to breastfeeding practice* • Establish fully breastfed, partially breastfed, and fully formula-fed categories, and set maximum formula allowances for each. Food Package I currently specifies a single maximum formula amount for all Package I recipients; local WIC staff may tailor the amount of formula to reflect individual participant needs, based on frequency of breastfeeding. The new rule sets a maximum formula amount for partially breastfed infants age one month and older that is roughly half the maximum provided to fully formula fed infants. • Powder formula alone is recommended for partially breastfed infants. Powder and non-powder options remain available for fully formula fed infants. *Interim rule: No change from Proposed Rule.* *Proposed rule: Delay introduction of complementary foods.* Extend the age range of infants covered by Food Package I by two months. Currently, Food Package I supplements the diets of infants from birth through three months. Under the proposed rule, Food Package I would be provided to infants through five months of age. Under both the current and proposed rules, Food Package I contains no complementary foods. Extending the age range of infants served by Food Package I removes complementary foods (juice and infant cereal) from the food packages for four and five-month-old infants, which is consistent with current infant feeding practice guidelines. *Interim rule: No change from Proposed Rule.* *Proposed rule: Increase maximum formula prescription at four months.* Increase the maximum amount of formula allowed for four and five-month-old infants (relative to the amount allowed under current rules.) *Interim rule: No change from Proposed Rule.* *Proposed rule: No partially breastfed category for infants under one month.* Do not provide formula to breastfed infants under one month old. Infants under one month will be recognized as either fully breastfed or fully formula-fed. No infant will be prescribed formula in the amount specified by Food Package I for partially breastfed infants until he or she reaches one month. *Interim rule: Provide formula to partially breastfed infants under one month.* Partially breastfed infants ages 0 through 1 month may receive the equivalent of not more than 104 fluid ounces of reconstituted infant formula, approximately one can of powder infant formula. *Rationale:* The interim rule intends to encourage mothers to continue a practice of breastfeeding that may have begun at the hospital. However, FNS recognizes the need for States to have the flexibility to provide a small amount of formula in the first month of life, if necessary, to assist breastfeeding mothers who may otherwise choose to formula feed. Powder infant formula is recommended due to its longer shelf life and to minimize waste. Individual amounts may be tailored by a Competent Professional Authority based on the assessed needs of the breastfeeding infant. *Proposed rule: No low iron formula.* Discontinue the prescription of low iron infant formula for infants of all ages. *Interim rule: No change from Proposed Rule.* *Proposed rule: Reclassify prescriptions of exempt infant formula under Package III.* Administer exempt formulas, other than those prescribed for common food allergies, under Food Package III. Currently, all infants are classified as recipients of Food Packages I or II. This proposal would simply reclassify certain Package I (and II) recipients as Package III recipients; it is not intended to alter the types of foods prescribed to infants with qualifying conditions. *Interim rule: No change from Proposed Rule.* 2. Food Package II—Infants 6 Through 11 Months *Proposed rule: Delay introduction of complementary foods.* Delay the age at which infants become eligible for Food Package II. Infants are currently made eligible for Food Package II and its complementary foods at four months of age. The proposed rule would make infants age one month or older eligible for Package II foods at six months of age. *Interim rule: No change from Proposed Rule.* *Proposed rule: Tie maximum formula prescription to breastfeeding practice.* Establish fully breastfed, partially breastfed, and fully formula-fed categories, and set maximum formula allowances for each. The new rule sets a maximum formula amount for partially breastfed infants that is roughly half the maximum provided to fully formula-fed infants. *Interim rule: No change from Proposed Rule.* *Proposed rule: Reduce maximum formula prescription amounts.* Reduce the amount of formula, relative to current rules, for partially breastfed and fully formula-fed infants. *Interim rule: No change from Proposed Rule.* *Proposed rule: Replace infant's juice with fruits and vegetables* • Eliminate juice from Food Package II. Add infant food fruits and vegetables to the package. Allow fresh bananas as a substitute for a portion of the infant food fruits and vegetables. • Provide more infant food fruits and vegetables to fully breastfed infants than to partially breastfed or fully formula-fed infants. *Interim rule: No change from Proposed Rule.* *Proposed rule: Provide infant food meat to fully breastfed infants.* Add infant food meat to Package II for fully breastfed infants. *Interim rule: No change from Proposed Rule.* *Proposed rule: No low iron formula.* Discontinue the prescription of low iron infant formula. *Interim rule: No change from Proposed Rule.* *Proposed rule: Reclassify prescriptions of exempt infant formula under Package III.* Administer exempt formulas to infants under Food Package III. *Interim rule: No change from Proposed Rule.* *Proposed rule: Disallow prescription of infant cereal with added ingredients.* Infant cereal with added fruit, milk, formula, or other non-grain foods may not be prescribed under Food Package II. *Interim rule: No change from Proposed Rule.* 3. Food Package III—Medically Fragile Participants *Proposed rule: Administer exempt formulas to infants with qualifying conditions under Package III* Infants with a qualifying condition (see below) who currently receive exempt infant formulas would be moved from Package I or Package II to Package III. *Interim rule:* In addition to the provisions of the Proposed Rule, the interim rule will allow medically fragile infants 6 months of age or greater whose medical condition prevents them from consuming complementary infant foods (cereal, fruit and vegetables, and meat) to receive exempt infant formula or WIC-eligible medical foods at the same maximum monthly allowance as infants ages 4 through 5 months of the same feeding option. *Rationale:* Comments expressed concern about medically fragile infants 6 months of age or greater whose medical condition prevents them from consuming complementary infant foods. The allowance of exempt infant formula or WIC-eligible medical foods will replace nutrition that would result from the addition of complementary foods. *Proposal Rule: Clarify language governing Package III's purpose and scope* • The proposed rule would provide additional guidance to States on the nature of medical conditions that qualify a WIC participant for Package III medical foods. • Prescription of a medical food would also require additional justification and instructions by a licensed health care professional. *Interim rule: No change from Proposed Rule.* *Proposed rule: Make non-Package III foods available to Package III recipients.* In addition to the medical foods and exempt formulas currently prescribed to Package III recipients, the proposed rule would offer these individuals all of the foods in the packages to which they would have been eligible in the absence of their special medical needs. *Interim rule:* No change from Proposed Rule, with the exception of whole milk. Whole milk will be authorized for children 1 through 4 years of age and women receiving Food Package III, with medical documentation. 4. Food Package IV—Children From Age One up to Age Five *Proposed rule: Reduce the prescribed amount of milk; modify substitution options* • The maximum amount of milk that may be prescribed to children would be reduced from 24 quarts to 16 quarts per month. • Under current rules, cheese may be prescribed as a substitute for up to 12 quarts of milk. The proposed rule would allow cheese to replace up to three quarts of milk. The substitution rate of one pound of cheese for three quarts of milk would remain unchanged. • Soy products will be allowed as a milk substitute on a restricted basis; soy may only be prescribed to children with a documented medical need. *Interim rule:* In addition to the provisions of the Proposed Rule, the interim rule clarifies the authorization of lactose-reduced and lactose-free milk, and that these products should be offered before other authorized milk substitutes to those participants who cannot drink milk due to lactose intolerance. The interim rule also clarifies that medical documentation is not required for participants to receive lactose-reduced and lactose-free milk. *Rationale:* The IOM emphasized the importance of milk in the diets of WIC participants, and approached the issue of milk substitutes with caution. The IOM considered and rejected the substitution of soy products for milk in the revised childrens' food package without documented medical need. *Proposed rule: Provide only fat-reduced milk to older children.* Prescribe only fat-reduced milk to children age two and above. Prescribe only whole milk to children under age two. *Interim rule: No change from Proposed Rule.* *Proposed rule: Modify/clarify reconstitution rates for dry and evaporated milk.* The reconstitution rate for evaporated milk is changed from 13 to 16 ounces of evaporated milk per reconstituted quart. The reconstitution rate for powdered milk is restated in terms of fluid ounces rather than quarts; this change does not alter the reconstitution rate itself. *Interim rule: No change from Proposed Rule.* *Proposed rule: Reduce juice prescriptions; add fruits and vegetables.* • Reduce monthly maximum juice prescription from 288 fluid ounces to 128. Clarify that juice must be 100% unsweetened fruit or vegetable juice, that it contain a minimum of 30 milligrams of vitamin C per 100 milliliters, and that it be pasteurized. • Add a $6 monthly voucher to the package for the purchase of any combination of fresh or processed fruits and vegetables other than white potatoes. *Interim rule: No change from Proposed Rule.* *Proposed rule: Add whole grain breads; add whole grain requirement to cereal.* • Add two pounds of whole grain bread to the food package. Only bread meeting U.S. Food and Drug Administration

(FDA)standards for whole grain labeling would be allowed. 12 12 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/dms/flgrain2.html* . • Several whole grain products would be allowed as substitutions for bread. These include brown rice, bulgur, and whole grain barley without added sugar, fat, oil, or sodium. Soft corn or whole wheat tortillas would be allowed as an additional substitute at the option of State agencies. States may limit or completely eliminate substitutes if needed to control food costs. • Require that WIC authorized breakfast cereals 13 meet the same whole grain requirements as bread. 13 The proposed rule would also replace the existing terms “cereal (hot or cold)” and “adult cereal (hot or cold)” with “breakfast cereal” in 7 CFR 246.10(c). *Interim rule: Revise proposed whole grain requirements.* • The cereal whole grain requirement in the Proposed Rule will be modified to require that at least one half of the total number of breakfast cereals on a State's authorized food list meet the whole grain requirement as defined in the interim rule, and that vendors be required to stock at least one whole grain cereal. The remaining authorized breakfast cereals are required to meet only the iron and sugar requirements. • To assist in the identification of whole grain bread, cereal, and whole grain foods, the interim rule adds the requirement that a whole grain must be the primary ingredient by weight in all bread, cereal and whole grain products. *Rationale:* • Comments expressed concern that the proposed nutritional requirement for whole grain breakfast cereal (using FDA's Health Claim 14 ) is too restrictive and would eliminate corn and rice-based cereals that are necessary for those participants with wheat allergies or strong preferences for corn and rice-based cereals. In addition, commenters stated that whole grain cereals are less palatable to young children. 14 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/dms/flgrain2.html* . • Comments expressed concern about administrative difficulties in the identification of whole wheat bread and whole grain foods. To ensure State agencies determine the correct foods to authorize for State food lists, the Department has determined that whole-grain foods must have a whole-grain as the primary ingredient. This will allow products that are 100 percent whole grain, or are primarily whole wheat or multi-grain, to be WIC-eligible as well as provide an easy way for participants and vendors to identify most whole grain bread products by using the food ingredient label. 15 15 Baked in-store breads generally have no label. *Proposed rule: Reduce maximum egg prescription.* Reduce the maximum egg prescription from two and one-half dozen per month 16 to one dozen. 16 Some states currently allow just two dozen as the monthly maximum. *Interim rule: No change from Proposed Rule.* *Proposed rule: Allow canned beans as a substitute for dry beans.* Allow canned beans as a substitute for dry at the rate of sixty-four ounces per pound. *Interim rule: No change from Proposed Rule.* 5. Food Package V—Pregnant and Partially Breastfeeding Women Up to One Year Postpartum *Proposed rule: Condition eligibility for Package V on breastfeeding practice.* Mothers who request, and are prescribed, more than the maximum amount of formula allowed for partially breastfed infants will no longer be eligible for Food Package V. Currently, women who breastfeed at least once per day are eligible for this package. Reclassified as non-breastfeeding for purposes of WIC food package issuance, these women will be assigned Food Package VI up to six months postpartum; they will receive no food package after six months. *Interim rule: No change from Proposed Rule.* *Proposed rule: Reduce the prescribed amount of milk; introduce new substitution options.* • The maximum amount of milk that may be prescribed to Package V recipients would be reduced from 28 quarts to 22 quarts per month. • Under current rules, cheese may be prescribed as a substitute for up to 12 quarts of milk. The proposed rule would allow cheese to replace just three quarts of milk. The substitution rate of one pound of cheese for three quarts of milk would remain unchanged. • Calcium-set tofu 17 , and calcium and vitamin D fortified soy beverage would be introduced as new milk substitutes. Each pound of tofu would replace one quart of milk. For most women, cheese and tofu, combined, could replace no more than four quarts of milk; women with documented medical needs may be prescribed these substitutes in amounts that exceed the four quart maximum. No more than one pound of cheese may be substituted for milk. 17 Tofu prepared with only calcium salts. • Soy beverage would be allowed as a substitute for Package V's entire milk allowance. • IOM recommended yogurt as an alternative to fluid milk. To ensure cost neutrality yogurt was omitted as a fluid milk substitution. (See discussion of yogurt as a milk substitute in Section F, Item 1.) *Interim rule:* In addition to the provisions of the Proposed Rule, the interim rule clarifies the authorization of lactose-reduced and lactose-free milk, and that these products should be offered before other authorized milk substitutes to those participants who can not drink milk due to lactose intolerance. The interim rule also clarifies that medical documentation is not required for participants to receive lactose-reduced and lactose-free milk. *Rationale:* Lactose-reduced and lactose-free milks conform to the FDA standard of identity. The authorization of these milks was not specified in the Proposed Rule. *Proposed rule: Reduce maximum juice prescription; add fruits and vegetables.* • Reduce monthly maximum juice prescription from 288 fluid ounces to 144. Clarify that juice must be 100% unsweetened fruit or vegetable juice, that it contain a minimum of 30 milligrams of vitamin C per 100 milliliters, and that it be pasteurized. • Add an $8 monthly voucher to the package for the purchase of any combination of fresh or processed fruits and vegetables other than white potatoes. *Interim rule: No change from Proposed Rule.* *Proposed rule: Add whole grain breads; add whole grain requirement to cereal.* • Add one pound of whole grain bread to the food package. Only bread meeting U.S. Food and Drug Administration

(FDA)standards for whole grain labeling would be allowed. 18 18 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/dms/flgrain2.html* . • Several whole grain products would be allowed as substitutions for bread. These include brown rice, bulgur, and whole grain barley without added sugar, fat, oil, or sodium. Soft corn or whole wheat tortillas would be allowed as an additional substitute at the option of State agencies. States may limit or completely eliminate substitutes if needed to control food costs. • Require that WIC authorized breakfast cereals meet the same whole grain requirements as bread. *Interim rule: Revise proposed whole grain requirements.* • The cereal whole grain requirement in the Proposed Rule will be modified to require that at least one half of the total number of breakfast cereals on a State's authorized food list meet the whole grain requirement as defined in the interim rule, and that vendors be required to stock at least one whole grain cereal. The remaining authorized breakfast cereals are required to meet only the iron and sugar requirements. • To assist in the identification of whole grain bread and whole grain foods, the interim rule adds the requirement that a whole grain must be the primary ingredient by weight in all bread products. *Rationale:* • Comments expressed concern that the proposed nutritional requirement for whole grain breakfast cereal (using FDA's Health Claim 19 ) is too restrictive and would eliminate corn and rice-based cereals that are necessary for those participants with wheat allergies or strong preferences for corn and rice-based cereals. 19 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/dms/flgrain2.html* . • Comments expressed concern about administrative difficulties in the identification of whole wheat bread and whole grain foods. To ensure State agencies determine the correct foods to authorize for State food lists, the Department has determined that whole-grain foods must have a whole-grain as the primary ingredient. This will allow products that are 100 percent whole grain, or are primarily whole wheat or multi-grain, to be WIC-eligible as well as provide an easy way for participants and vendors to identify whole grain bread products by using the food label. *Proposed rule: Reduce maximum egg prescription.* Reduce the maximum egg prescription from two and one-half dozen per month to one dozen. *Interim rule: No change from Proposed Rule.* *Proposed rule: Allow canned beans as a substitute for dry beans.* Allow canned beans as a substitute for dry at the rate of sixty-four ounces per pound. *Interim rule: No change from Proposed Rule.* *Proposed rule: Increase total amount of peanut butter and beans.* Peanut butter is currently offered as a substitute for dry beans. The proposal would provide both one pound of dry beans and 18 ounces of peanut butter to Package V recipients. The rule also clarifies that Package V recipients may replace both dry beans and peanut butter with canned beans. *Interim rule: No change from Proposed Rule.* 6. Food Package VI—Postpartum Women (Up to Six Months Postpartum) *Proposed rule: Reduce the prescribed amount of milk; introduce new substitution options.* • The maximum amount of milk that may be prescribed to Package VI recipients would be reduced from 24 quarts to 16 quarts per month. • Under current rules, cheese may be prescribed as a substitute for up to 12 quarts of milk. The proposed rule would allow cheese to replace just three quarts of milk. The substitution rate of one pound of cheese for three quarts of milk would remain unchanged. Calcium-set tofu, and calcium and vitamin D fortified soy beverage would be introduced as new milk substitutes. Each pound of tofu would replace one quart of milk. For most women, cheese and tofu, combined, could replace no more than four quarts of milk; women with documented medical needs may be prescribed these substitutes in amounts that exceed the four quart maximum. No more than one pound of cheese may be substituted for milk. • Soy beverage would be allowed as a substitute for Package VI's entire milk allowance. • IOM recommended yogurt as an alternative to fluid milk. To ensure cost neutrality yogurt was omitted as a fluid milk substitution. (See discussion of yogurt as a milk substitute in Section F, Item 1.) *Interim rule:* In addition to the provisions of the Proposed Rule, the interim rule clarifies the authorization of lactose-reduced and lactose-free milk, and that these products should be offered before other authorized milk substitutes to those participants who can not drink milk due to lactose intolerance. The interim rule also clarifies that medical documentation is not required for participants to receive lactose-reduced and lactose-free milk. *Rationale:* Lactose-reduced and lactose-free milks conform to the FDA standard of identity. The authorization of these milks was not specified in the Proposed Rule. *Proposed rule: Reduce maximum juice prescription; add fruits and vegetables.* • Reduce monthly maximum juice prescription from 192 fluid ounces to 96. Clarify that juice must be 100% unsweetened fruit or vegetable juice, that it contain a minimum of 30 milligrams of vitamin C per 100 milliliters, and that it be pasteurized. • Add an $8 monthly voucher to the package for the purchase of any combination of fresh or processed fruits and vegetables other than white potatoes. *Interim rule: No change from Proposed Rule.* *Proposed rule: Add whole grain requirement to cereal.* • Require that WIC authorized breakfast cereals meet the same whole grain requirements as bread. *Interim rule: Add whole grain requirement to cereal.* The cereal whole grain requirement in the Proposed Rule will be modified to require that at least one half of the total number of breakfast cereals on the State's authorized food list meet the whole grain requirement as defined in the interim rule, and that vendors be required to stock at least one whole grain cereal. The remaining authorized breakfast cereals are required to meet only the iron and sugar requirements. To assist in the identification of whole grain cereal, the interim rule adds the requirement that a whole grain must be the primary ingredient by weight. *Rationale:* Comments expressed concern that the proposed nutritional requirement for whole grain breakfast cereal (using FDA's Health Claim 20 ) is too restrictive and would eliminate corn and rice-based cereals that are necessary for those participants with wheat allergies or strong preferences for corn and rice-based cereals. Comments also expressed concern about administrative difficulties in the identification of whole wheat bread and whole grain foods. To ensure State agencies determine the correct foods to authorize for State food lists, the Department has determined that whole-grain foods must have a whole-grain as the primary ingredient. 20 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content* at *http://www.cfsan.fda.gov/dms/flgrain2.html* . *Proposed rule: Reduce maximum egg prescription.* Reduce the maximum egg prescription from two and one-half dozen per month to one dozen. *Interim rule: No change from Proposed Rule.* *Proposed rule: Add beans and peanut butter to the food package.* One pound of dry beans or 18 ounces of peanut butter would be added to Package VI. The same canned bean substitution option added to Packages IV, V, and VII would be extended to Package VI recipients as well. *Interim rule:* *No change from Proposed Rule.* 7. Food Package VII—Exclusively Breastfeeding Women *Proposed rule:* *Reduce the prescribed amount of milk; introduce new substitution options.* • The maximum amount of milk that may be prescribed to Package VII recipients would be reduced from 28 quarts to 24 quarts per month. • Under current rules, cheese may be prescribed as a substitute for up to 12 quarts of milk. The proposed rule would allow cheese to replace just six quarts of milk. The substitution rate of one pound of cheese for three quarts of milk would remain unchanged. • Calcium-set tofu, and calcium and vitamin D fortified soy beverage would be introduced as new milk substitutes. Each pound of tofu would replace one quart of milk. For most women, cheese and tofu, combined, could replace no more than six quarts of milk; women with documented medical needs may be prescribed these substitutes in amounts that exceed the six quart maximum. No more than two pounds of cheese may be substituted for milk. • Soy beverage would be allowed as a substitute for Package VII's entire milk allowance. • IOM recommended yogurt as an alternative to fluid milk. To ensure cost neutrality yogurt was omitted as a fluid milk substitution. (See discussion of yogurt as a milk substitute in Section F, Item 1.) *Interim rule:* In addition to the provisions of the Proposed Rule, the interim rule clarifies the authorization of lactose-reduced and lactose-free milk, and that these products should be offered before other authorized milk substitutes to those participants who can not drink milk due to lactose intolerance. The interim rule also clarifies that medical documentation is not required for participants to receive lactose-reduced and lactose-free milk. *Rationale:* Lactose-reduced and lactose-free milks conform to the FDA standard of identity. The authorization of these milks was not specified in the Proposed Rule. *Proposed rule:* *Reduce maximum juice prescription; add fruits and vegetables.* • Reduce monthly maximum juice prescription from 336 fluid ounces to 144. Clarify that juice must be 100% unsweetened fruit or vegetable juice, that it contain a minimum of 30 milligrams of vitamin C per 100 milliliters, and that it be pasteurized. • Add an $8 monthly voucher to the package for the purchase of any combination of fresh or processed fruits and vegetables other than white potatoes. • Eliminate the separate prescription of carrots. *Interim rule:* The provision of an $8 monthly voucher has been revised to reflect a $10 monthly voucher. *Rationale:* IOM recommended cash-value food instruments for fruits and vegetables at the level of $10 per month for women. To ensure cost neutrality, cash-value food instruments for fruits and vegetable was decreased to $8 per month for women. However, FNS has considered the benefits of increasing the value of the vouchers for fully breastfeeding women and has determined that a $2 increase can be accomplished while maintaining cost neutrality. In addition, the increase further enhances the attractiveness of the fully breastfeeding package and provides an additional incentive for women to breastfed. *Proposed rule:* *Add whole grain breads; add whole grain requirement to cereal.* • Add one pound of whole grain bread to the food package. Only bread meeting U.S. Food and Drug Administration

(FDA)standards for whole grain labeling would be allowed. 21 21 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content at http://www.cfsan.fda.gov/~dms/flgrain2.html.* • Several whole grain products would be allowed as substitutions for bread. These include brown rice, bulgur, and whole grain barley without added sugar, fat, oil, or sodium. Soft corn or whole wheat tortillas would be allowed as an additional substitute at the option of State agencies. States may limit substitutes if needed to control food costs. *Interim rule:* *Revise proposed whole grain requirements.* • The cereal whole grain requirement in the Proposed Rule will be modified to require that at least one half of the total number of breakfast cereals on the State's authorized food list meet the whole grain requirement as defined in the interim rule, and that vendors be required to stock at least one whole grain cereal. The remaining authorized breakfast cereals are required to meet only the iron and sugar requirements. • To assist in the identification of whole grain bread and whole grain foods, the interim rule adds the requirement that a whole grain must be the primary ingredient by weight in all bread products. *Rationale:* • Comments expressed concern that the proposed nutritional requirement for whole grain breakfast cereal (using FDA's Health Claim 22 ) is too restrictive and would eliminate corn and rice-based cereals that are necessary for those participants with wheat allergies or strong preferences for corn and rice-based cereals. 22 See 21 CFR Part 136, Section 136.180, and FDA's *Health Claim Notification for Whole Grain Foods with Moderate Fat Content at http://www.cfsan.fda.gov/~dms/flgrain2.html.* • Comments expressed concern about administrative difficulties in the identification of whole wheat bread and whole grain foods. To ensure State agencies determine the correct foods to authorize for State food lists, the Department has determined that whole-grain foods must have a whole-grain as the primary ingredient. This will allow products that are 100% whole grain, or are primarily whole wheat or multi-grain, to be WIC-eligible as well as provide an easy way for participants and vendors to identify whole grain bread products by using the food label. *Proposed rule:* *Reduce maximum egg prescription.* Reduce the maximum egg prescription from two and one-half dozen per month to one dozen. *Interim rule: No change from Proposed Rule.* *Proposed rule: Allow canned beans as a substitute for dry beans.* Allow canned beans as a substitute for dry at the rate of sixty-four ounces per pound. Also clarifies that Package VII recipients may replace both dry beans and peanut butter with canned beans. *Interim rule: No change from Proposed Rule.* *Proposed rule: Modify Package VII's canned fish provision.* • Increase the maximum canned fish prescription to 30 ounces. Clarify that fish packaged in foil pouches meets WIC requirements. • Allow three varieties of canned fish (light tuna, salmon and sardines) that are cost-effective and do not pose a mercury hazard as identified by federal advisories of the Food and Drug Administration and the U.S. Environmental Protection Agency for breastfeeding women. *Interim rule:* The interim rule allows canned mackerel in addition to canned salmon and sardines, and light tuna. *Rationale:* In response to comment requests, the interim rule also allows canned mackerel. The rule specifies two species of mackerel, both of which are also cost-effective and identified by the EPA and FDA as having “lower levels of mercury.” 8. Other Provisions (Non Food-Package Specific) *Proposed rule: Clarifies the right of States to impose restrictions on WIC foods.* States retain the right to exclude particular products, by brand or variety, from the food packages distributed to their residents. States are authorized to set standards for WIC foods that are more restrictive than those set by the federal government; however, they may not authorize the prescription of foods that do not meet minimum WIC-eligibility requirements set forth in regulations. The States may take into account issues of cost, nutrition, statewide availability, and participant appeal in setting these restrictions. *Interim rule: No change from Proposed Rule.* *Proposed rule: Ends the state practice of categorical nutritional tailoring.* States will no longer be permitted to construct their own standardized set of food packages for WIC subpopulations with common supplemental nutritional needs. The full maximum monthly allowances of all foods in all packages must be made available to participants if medically or nutritionally warranted. However, State agencies have the authority to make adjustments to WIC foods for administrative convenience and to control costs. Such adjustments may involve packaging methods, container sizes, brands, types and physical forms of WIC foods. *Interim rule: No change from Proposed Rule.* *Proposed rule: Prohibit States from proposing new food package substitutions.* The increased variety and choice in the supplemental foods in the Proposed Rule is based on IOM recommendations and the consideration of cultural appropriate packages for diverse groups. Therefore, WIC State agency proposal for cultural food substitutions will no longer be considered. Future reviews of the WIC food packages by FNS will be used to determine the need for additional cultural accommodations. *Interim rule:* State agencies may submit to FNS a plan for substitution of foods to allow for different cultural eating patterns. The plan shall provide the State agency's justification, including a specific explanation of the cultural eating pattern and other information necessary for FNS to evaluate the plan. FNS will evaluate a State agency's plan for substitution of foods for different cultural eating patterns based on the following criteria:

(1)Any proposed substitute food must be nutritionally equivalent or superior to the food it is intended to replace;

(2)The proposed substitute must be widely available to participants in the areas where the substitute is intended to be used; and

(3)The cost of the substitute must be equivalent to or less than the cost of the food it is intended to replace. These criteria are the same as those under current WIC regulations at 7 CFR 246.10(e). *Rationale:* Comments requested that the interim rule allow States the flexibility to meet unanticipated cultural needs of participants. *Proposed rule: Rounding up for infant food and infant cereal* A state agency may round up to the next whole container for either infant formula or infant foods (infant cereal, fruits and meats) if needed to provide at least the maximum authorized amount of these foods. For infant formula, state agencies must issue the whole containers that provide at the least the full nutritional benefit (the maximum allowance of reconstituted fluid ounces of liquid concentrate) but not more than the maximum allowance of infant formula for each food package category and infant feeding option. *Interim rule:* *No change from Proposed Rule.* C. Summary of Key Provisions The expected impact of the interim rules on the federal government, state and local WIC agencies, vendors, manufacturers, and program participants is summarized in Table 1. Overall economic effects are noted with a “+$” for cost increases, and a “−$” for cost savings. A more detailed examination of strictly economic effects follows Table 1. Table 1.—Summary of Key Provisions Current and interim rules: Effect of interim rule on: USDA/Federal gov't State/local agencies Vendors/industry WIC participants Current rule: 1. Food Package I serves infants from birth through three months. Formula is the only food prescribed under Package I. Reduces cost of infant food packages. Interim packages for four and five month old infants (which reduce calories slightly) are less expensive than current Food Package II. Changes to current rules will require the implementation of new state and local administrative procedures. May increase the sale of infant formula at the expense of juice and infant cereal. Provides a food package that conforms more closely to the diet recommended by health professionals for four and five month old infants. 2. Infants from four through eleven months are eligible for juice and infant cereal, in addition to formula, under Package II. The maximum formula prescription in packages I and II are the same. Interim rule: 1. Expand Food Package I to serve infants up to six months. Delay the introduction of complementary foods by two months. 2. Increase formula prescriptions at four months to offset lost food energy. −$ Current rule: Under Food Package I, an infant can receive up to the maximum infant formula for the package. Since the rule does not separate partially and fully formula fed infants, a single package maximum applies to all partially and fully formula-fed infants from birth through three months. Food Package V is provided to pregnant women and to all new mothers, up to one year postpartum, if they breastfeed at least once per day. Food Package VII is provided to fully breastfeeding mothers. Interim rule: Infants and mothers will be assigned food packages based on the mother's reported breastfeeding practice. The corresponding amount of formula prescribed will distinguish infants less than 4 months of age as partially breastfed or fully formula-fed. The rule would provide a full formula-feeding package to some infants currently considered partially breastfed; it would move some mothers from Package V to Package VI. Partially breastfed infants under one month of age would be allowed to receive limited infant formula; this would move some mothers from Package VI or VII to Package V. −$ If breastfeeding increases enough to keep an infant classified as partially breastfed who would have been classified as fully formula fed otherwise, then formula costs are reduced and there is no change in the mother's status. For partially breastfed infants under one month of age, the low formula limit provided during that first month, paired with the net effect of mothers and infants switching from fully-formula feeding or fully breastfeeding to partially breastfeeding during the first month may reduce costs during the infant's first month. However, a sustained increase in breastfeeding during an infant's first year will affect the food package eligibility of both the mother and the infant. Although the economic effect of such a sustained increase is dependent on both breastfeeding duration and on the relative rates of partial and exclusive breastfeeding, the net economic effect is likely to be a reduction in cost. State and local agencies must develop new guidelines to implement and communicate this policy. Negligible effect on the sale of infant formula for newborn infants. But, the rule provides an incentive to breastfeed, which may ultimately reduce formula sales beyond the infants' first month. Moving mothers from the fully formula fed package to the partially or exclusively breastfeeding packages, may slightly increase food sales to breastfeeding mothers. Although some participants may receive less food or formula under the interim packages, in general, WIC infants and mothers will benefit from the enhanced packages and package assignment method. Breastfeeding education and limited formula provided to new mothers by WIC staff may successfully increase breastfeeding rates. This is consistent with the recommendations of nutrition experts. However, it is uncertain whether this will have a significant impact on the number of WIC women who breastfeed. Current rule: The current infant food packages do not distinguish between fully and partially formula-fed infants. Infants receive infant formula based on an assessment of their supplemental nutritional needs, subject to a single package maximum. Food Package V is provided to pregnant women and to all new mothers, up to one year postpartum, if they breastfeed at least once per day and their infant receives some formula. If the interim rule has no direct effect on the initiation and duration of breastfeeding, the cost of providing food packages to women will drop; the cost of providing infant formula will remain unchanged. If breastfeeding increases enough to keep an infant classified as partially breastfed who would have been classified as fully formula fed otherwise, then formula costs are reduced and there is no change in the mother's status. Both result in cost reductions. State and local agencies must conform to a new definition of breastfeeding for WIC food package purposes. Will also encourage changes in the approach to nutrition education; places greater emphasis on breastfeeding promotion. Implementing new procedures will initially increase administrative burden. Negligible effect in the absence of changes in breastfeeding behavior. Increased breastfeeding would reduce formula sales but might modestly increase the sale of infant food fruits, vegetables and meat to WIC's fully breastfed population. Although the WIC food benefit received by women who do not fully breastfeed may be reduced, in general, WIC infants and mothers will benefit from the enhanced packages and package assignment method. The interim packages encourage breastfeeding consistent with the best advice of nutrition science. However, breastfeeding is a behavior with many complex determinants, and it is unlikely that the food package changes alone will alter breastfeeding practices. Interim rule: Infants and mothers will be assigned food packages based on the mother's reported breastfeeding practice. The corresponding amount of formula prescribed will distinguish infants between partially breastfed and fully formula-fed. The rule would provide a full formula-feeding package to some infants currently considered partially breastfed; it would move some mothers from Package V to Package VI, or after six months of participation, to no package at all, depending on the amount of formula requested. −$ Current rule: Currently, the definition of breastfeeding in WIC regulations allows women who breastfeed once a day to be eligible for the WIC program and receive supplemental foods. These women are already counted as participants when they receive food benefits as breastfeeding women, so the net effect of the change in the definition of participation is minimal. These women will continue to be included in participation numbers and State agencies will be provided NSA funds. State agencies will be provided NSA funds for a very small number of women who are receiving WIC benefits (nutrition education/breastfeeding support and referrals to health and social services), but not receiving supplemental foods. Negligible effect because it applies only to the few women who breastfeed for longer than six months but request the full formula fed amount of infant formula for their infant. These mothers once received supplemental foods but will no longer be eligible for these foods. They will still be visiting WIC approved vendors to obtain infant formula. Encourages more intensive breastfeeding for WIC women after six months of participation. Interim rule: Revise the definition for WIC participation to include the number of breastfeeding women who receive no supplemental foods or food instruments but whose breastfed infant(s) receives supplemental foods or food instruments. −$ Current rule: Infants from 4-11 months are eligible for Food Package II. That food package includes juice and infant cereal, as well as formula. The net effect of these changes increases the cost of Food Package II. Implementing new procedures, such as setting state policy on allowed varieties of infant food, will increase short-term administrative burden. MIS systems will need to be revised for new foods (infant fruits and vegetables), quantities, and the new age range. Need to train WIC staff, vendors and participants on new foods. May increase sales of infant food and decrease sales of juice and formula if participants were not already using the quantities in the interim rule. Some vendors may need to stock additional infant food varieties that meet the specific specifications set by the states. Vendors will need to train personnel to identify the newly WIC-eligible infant foods. Restructures the infant package according to the recommendations of current nutrition science. Increases benefits by adding fruits and vegetables, but decreases maximum allowance of infant formula and eliminates juice. Encourages good infant feeding practices and the consumption of fruits and vegetables. Interim rule: The following changes are made to Food Package II: 1. Change age eligibility to 6-11 months. 2. Eliminate juice. 3. Add infant food fruits and vegetables. 4. Reduce maximum formula amount. +$ Current rule: All infants are eligible for the same amounts of formula, juice, and infant cereal under Food Package II. The cost of the fully breastfed package for infants age six months and older is increased significantly. Implementing new procedures, such as setting state rules on permissible varieties of infant food meat, will increase short-term administrative burden. Need to train WIC staff, vendors and participants on new foods. MIS systems will need to be revised. Increase in sales of infant food meat is likely to be negligible. The number of fully breastfed WIC infants age six months and over is small. Vendors will need to train personnel to identify the newly WIC-eligible infant foods and distinguish them from similarly packaged ineligible items. Provides added iron and zinc to the diet of fully breastfed infants age six months and older. Also encourages breastfeeding by increasing benefits. Both are consistent with the recommendations of current nutrition science. Interim rule: Provide relatively more infant food fruit and vegetables to fully breastfed infants at six months than to partially breastfed or fully formula-fed infants. Also provide infant food meat to this group. +$ Current rule: 1. Low iron infant formula may be prescribed with medical documentation. 2. Infant cereal must be iron-fortified; WIC regulations contain no other specifications. These changes are expected to have little effect on the foods actually prescribed to WIC infants. The infant cereal rule simply formalizes what has been federal policy since 1980. The states will incur minimal short-term administrative burden as they implement these minor rule changes. Local WIC agencies will need to communicate the “no low iron infant formula from WIC” concept to the local medical community and some participants. MIS systems will need to be revised. Sales of low iron formula and certain infant cereal varieties will be reduced slightly, if at all, by these rules. The very few WIC participants who have been receiving low iron formula from WIC will either need to purchase the product or work with their medical provider to change to an iron fortified infant formula authorized by WIC. Interim rule: 1. Disallow the prescription of low iron infant formula. 2. Disallow the prescription of infant cereal with added ingredients. (minimal economic effect) Current rule: Children and women with special dietary needs are prescribed WIC-eligible medical foods under Food Package III. Infants with special dietary needs are provided exempt infant formula under Food Packages I or II. The rule is intended to reduce administrative costs and facilitate program management. The rule is intended to facilitate program management. It may also allow improved service to WIC beneficiaries. MIS systems will need to be revised. No impact. No direct impact. Improved service at the state and local level may result, to the benefit of WIC participants. Interim rule: Serve infants with special dietary needs who receive exempt infant formulas under Food Package III. −$ Current rule: Current practice allows some women and children with certain dietary restrictions, but without serious medical conditions, to be prescribed medical foods under Food Package III. Clarifies who is eligible for Food Package III and what foods may be distributed as part of that package. These clarifications are generally aimed at tightening these criteria. Will, if anything, reduce Package III costs by moving some participants to food packages more appropriate for their needs. But, given the size of the current Package III population (roughly 1% of all WIC participants) these savings will be small. The rule may reduce administrative burden by eliminating Package III eligibility issues. But, it may require state efforts to educate local WIC officials, WIC participants, and health care professionals on the eligibility criteria. Possible minimal reduction in the sale of medical foods due to eligibility requirements. Some current participants receiving Package III may be served under food packages more appropriate to their needs. Interim rule: Clarify language governing the purpose and scope of Package III eligibility. −$ Current rule: Package III recipients are prescribed medical foods only; they do not receive any of the standard food package foods. This rule will increase costs in those cases where Food Package III recipients are able to consume the foods contained in the regular WIC food packages to which they would otherwise be eligible. But, the Package III population is small. The costs will be modest. Administrative burden of implementing the new rule will be incurred in the short run. Local agencies will need to determine which WIC foods can be purchased to each Food Package III recipient. MIS systems will need to be revised. May have a small positive effect on the sale of some secondary WIC foods. Will not affect sales of infant formula. For those Package III recipients able to consume at least some non-Package III WIC foods, this rule will provide them with additional food. Interim rule: Make other WIC foods available to Package III recipients. +$ Current rule: Food Packages IV through VII provide WIC beneficiaries with 24 to 28 quarts of milk per month. Cheese may be substituted for milk at a rate of one pound per three quarts; cheese may replace a total of 12 quarts of milk. The net effect of this provision will be a reduction in overall cost, due to the reduction in quantities allowed and reduced substitution amounts. The states will need to establish new specifications and restrictions for the new milk substitutes. They will also incur administrative burden in implementing changes to reflect reduced milk prescription maximums and substitution limits. Local agencies will need to educate WIC vendors and participants on new food items. MIS systems will need to be revised. The rule may result in reduced milk and cheese sales to WIC participants. It may lead to increased sales of tofu and soy beverage. Vendors may need to stock new items that match the specific product requirements set by the states. Rule proposes nutritional standards for soy milk that are currently not met by many products on the market. Because these standards will also apply to the school meals programs, vendors are likely to change fortification so that the variety of available soy beverages that can be authorized improves over time. Reduces dairy component of WIC benefit. WIC participants who are unable to drink milk may benefit most by the addition of these new substitutes. Others with individual or cultural preferences will also benefit by the added choices. All WIC participants will benefit from a package lower in saturated and total fat, consistent with the recommendations of current nutrition science. Interim rule: Reduce maximum milk prescription amounts to WIC children and women. Add new milk substitution options (tofu, cheese and soy beverage), but reduce the maximum amount of cheese substitution allowed. −$ Current rule: Juice may be prescribed under Food Packages IV through VII at maximum levels that range from 192 to 336 fl. oz. per month. The fixed dollar values of the fruit and vegetable vouchers in the interim rule are greater than the offsetting savings that will be realized through reduced juice amounts. States will need to authorize and develop a structure to distribute and redeem fruit and vegetable vouchers, which will be a new component of the programs. This administrative burden will be on-going but part of the current banking and MIS systems. State and local agencies will incur administrative burden in developing educational messages for WIC participants concerning the selection of nutritious fruits and vegetables. Need to train WIC staff, vendors and participants on new food amounts. MIS systems will need to be revised. Juice sales to WIC participants may decline. Sales of fruits and vegetables may increase. Costs will be incurred by vendors as they learn to accommodate the new WIC vouchers. Some WIC authorized vendors may need to add fruits and vegetables to their stocks in fresh, frozen, or canned form. Emphasis on fresh fruits and vegetables may encourage states to authorize and participants to shop at farmers markets more often. (See Market Analysis discussion in Section G). Expands WIC benefits by adding fruits and vegetables, while reducing juice amounts. The addition of fruits and vegetables to the WIC food packages responds to the recommendations of nutrition science. And the flexibility of a voucher will provide access to a variety of fruits and vegetables, in some form, year round, in all markets. Interim rule: Reduce maximum juice prescription amounts in food packages for children and women. Add a voucher for fruits and vegetables (other than white potatoes) to those packages. +$ Current rule: Eggs are provided under Food Packages IV through VII. States may set their monthly maximums at either 2 or 2 1/2 dozen per month. Reducing the maximum egg prescription will produce a modest reduction in food package costs. That reduction is used to help offset costs of new foods and substitution options. State and local administrative burden will be incurred in the short term as new procedures are put in place. Local agencies will need to educate WIC vendors and participants on new food amounts. MIS systems will need to be revised. Sales of eggs to WIC participants will decline. Market effects will be minimal. This change reduces food energy, cholesterol, and fat content of the WIC food packages. The changes are consistent with the advice of current nutrition science. The reduction in food energy also makes room for the introduction of new foods that address priority nutrient needs. Interim rule: 1. Reduce maximum egg prescription in all food packages for women and children. −$ Current rule: There are no restrictions on the fat content allowed in milk. Prescribing only fat reduced milk to women and children age two and older will have a negligible effect on cost. State and local administrative burden will be incurred in the short term as new procedures are put in place. Local agencies will need to educate WIC vendors and participants on new food amounts. MIS systems will need to be revised. Market effects will be minimal. Vendors will need to train personnel to allow the type of milk specified on the food instruments. This proposal reduces total fat and saturated fat content of the WIC food packages. The change is consistent with the advice of current nutrition science. Interim rule: 1. Provide only fat reduced milk to women as well as children age two and older. 2. Provide only whole milk to children one year of age. −$ Current rule: Grains are included in the current food packages for women and children in the form of breakfast cereal. Current regulations do not specify a minimum whole grain content for that product. The addition of whole grain bread to Packages IV, V, and VII increases the cost of those packages. The requirement for 50 percent of available cereals for children and women to be classified as whole grain will have a minor effect on cost. State and local agencies will incur administrative burden to implement the new rules. States will incur administrative burden in establishing specifications and restrictions for the new foods and substitution options and local clinics will incur additional administrative burden to explain food options to participants. Local agencies will need to educate WIC vendors and participants on new food amounts and how to distinguish them from similarly packaged ineligible items. MIS systems will need to be revised. Manufacturers may respond by reformulating popular WIC-approved cereals in whole grain form. Smaller vendors may need to modify stocks to include whole grain bread varieties and at least one whole grain cereal. All vendors will need to train personnel to readily identify WIC-eligible breads and grains. WIC participants will benefit from food packaged enhanced with whole grain cereals and food products. The addition of whole grains to the WIC packages is consistent with 2005 Dietary Guidelines for Americans that encourage increased consumption of these foods. Interim rule: 1. Add whole grain bread to Food Packages IV, V, and VII. Allow substitutions of other whole grain foods for bread. 2. Require that at least 50 percent of breakfast cereals on State agency food lists must have whole grain as the primary ingredient and meet FDA labeling requirements for making a health claim as whole grain food of moderate fat content. 23 State agencies must require vendors to stock at least one whole grain cereal. +$ Current rule: Dry beans are included in Food Packages IV, V, and VII. Canned beans may be prescribed, instead of dry, to WIC participants who lack cooking facilities. The rate of substitution between canned and dry beans in the interim rule will increase costs. However, the cost of beans in the food packages is relatively small and this change will have a relatively modest effect on overall program cost. The option in the interim rule will prompt states to set specifications and restrictions. Other short-term administrative burden will be incurred as the new rule is put in place. Local agencies will need to educate WIC vendors and participants on new food amounts. MIS systems will need to be revised. Market effects will be minimal. But, as with the addition of any WIC substitution option, small vendors may need to add new items to their stocks, and all vendors will need to train personnel to identify the newly-eligible WIC foods. By adding variety and convenience, the canned bean option should increase the appeal of that food. It may also encourage greater consumption, replacing less healthy foods in the diets of WIC participants. Interim rule: 1. Allow canned beans as a substitute for dry in all food packages for children and women. 2. Allow both Package V and Package VII recipients to replace both their dry bean and peanut butter allocations with canned beans. +$ Current rule: Beans and peanut butter are not included in Food Package VI. Package V currently provides a pound of dry beans; those can be replaced with 18oz of peanut butter. The costs of food packages V and VI are increased. Neither of these changes introduces foods not already included in other WIC packages. Local agencies will need to educate WIC vendors and participants on new food amounts. MIS systems will need to be revised. Minimal market impact. The addition of beans and peanut butter increases benefits to WIC participants. These changes supplement the diets of breastfeeding and postpartum women with several of the priority nutrients identified by the IOM. Interim rule: 1. Add one pound of beans, with an 18oz peanut butter substitution option, to Food Package VI. 2. Increase the amount of beans and peanut butter allowed under Food Package V; allow the prescription of both one pound of beans and 18oz of peanut butter. +$ Current rule: 26 oz of tuna is made available to exclusively breastfeeding women in Food Package VII. White, light, or dark tuna, packed in water or oil, is allowed. Costs will increase slightly. While the new substitution option may increase the cost of individual prescriptions, the number of WIC participants eligible for Food Package VII is very small. States and local agencies will incur administrative burden in implementation. State agencies will adopt specifications and restrictions for the new substitution option. Local agencies will need to educate WIC vendors and participants on new food amounts. MIS systems will need to be revised. Minimal market impact. But, may force small vendors to stock additional types of canned fish and will require all vendors to train personnel to identify newly-eligible WIC foods. These changes add new choices that may encourage consumption. The rule also responds to medical advice that breastfeeding women avoid fish species that are high in mercury. Interim rule: Authorize a variety of canned fish that do not pose a mercury hazard to fully breastfeeding women. Slightly increase the maximum amount allowed to 30 ounces. +$ Current rule: State WIC agencies impose restrictions on some foods by brand or variety in order to limit cost or ensure statewide product availability. The practice is accepted but not formally authorized by regulation. This simply clarifies what is already accepted policy. The policy is an effective way to control costs. Since the rule represents no change from current practice, it results in no economic impact. States are given formal approval for current practice. States should incur little or no administrative burden in implementation. If States adopt restrictions on the brands or varieties of foods newly added to the WIC food packages, then participants who already purchase those foods may switch their selection of brands or varieties to the WIC-approved choices. A measurable shift in consumption by brand or variety may result. WIC participants may need to switch brands or varieties of foods that they currently consume to brands and varieties consistent with those added to the WIC packages. Interim rule: Clarifies the right of States to restrict WIC foods by variety or brand. (minimal economic impact) Current rule: States are permitted to prescribe foods to WIC participants in quantities that are less than the package maximums when nutritionally warranted. States may also standardize these reductions and apply the reduced amounts consistently to like groups of WIC participants. Such categorical food package tailoring may be done for nutritional reasons, but not to achieve cost reductions. Assures more consistent WIC benefits are delivered across States. The rule reduces the level of work currently undertaken by State officials. Administrative burden will decrease to the extent that states will not undertake their own review of WIC prescription maximums in response to the federal revisions to the WIC food packages. In the absence of this rule, States may have incurred administrative burden. Minimal effect on vendors and producers. Assures more consistent WIC benefits are delivered across States. IOM has based food prescription quantities on current nutritional science rendering food package tailoring unnecessary. Interim rule: Ends the practice of categorical tailoring of WIC food packages by States. −$ Interim rule: Allow State agencies to round up to the next whole container of infant foods if needed to provide the maximum authorized amount of these foods. Minimal cost given the small container sizes involved. Rounding up is likely to require the addition of little jarred infant food to the food packages; containers are typically just 4oz. The current infant cereal maximum of 24oz is a multiple of a commonly prescribed package size; 8oz boxes are among the standard package sizes. States may incur some administrative burden to implement, particularly if manufacturers change container sizes in response to this rule. Local agencies will need to educate WIC vendors and participants on rounded formula amounts. MIS systems will need to be revised. Unless manufacturers change container sizes to achieve greater product sales, no impact is expected. Will ensure WIC participants get the full nutritional benefit authorized. +$ Interim rule: Allow State agencies to propose plans for additional package substitutions to meet unanticipated cultural needs of participants. State agencies will only substitute foods after receiving written approval from FNS. Will increase administrative costs of considering proposals but little effect on program costs since very few package substitutions have ever been approved. Because of the interim rule's flexibility in food offerings, States will no longer have as much, if any, need to request substitutions to meet cultural preferences. Administrative savings will accrue for those States that do not pursue substitutions. Minimal since very few food package substitutions have ever been permitted. Minimal since very few food package substitutions have ever been permitted. D. Costs 1. Interim Rule Under the interim rule, FNS estimates that the revisions to the WIC food packages will be cost-neutral. FNS estimates that the changes will decrease costs by $29.7 million over five years. The economic effects of the interim rule on the federal government over a five-year period are summarized in Table 2, which presents the impacts of the revisions by food package type. These figures are limited to food costs; no additional funds will be provided to States or local clinics to implement this rule. The costs have been adjusted for the rule's phased-implementation schedule. Current and interim food package costs are provided in Tables A1-A3 in Appendix A. Table 2.—Projected Cost of WIC Food Package Revisions [in millions] Food package FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2008-FY 2012 I—Infants (0-5.9 months) −$12.6 −$44.4 −$53.4 −$55.8 −$58.3 −$224.5 II—Infants (6-11.9 months) 23.9 84.2 101.2 105.8 110.4 425.4 III—Participants with qualifying conditions 3.0 10.6 12.8 13.4 14.0 53.8 IV—Children (1-4.9 years) −18.4 −71.0 −92.0 −102.7 −113.8 −398.0 V—Pregnant and Partially Breastfeeding Women 6.5 20.8 22.6 21.2 19.7 90.9 VI—Postpartum Women 0.5 0.4 −0.9 −2.3 −3.8 −6.3 VII—Exclusively Breastfeeding Women 2.1 6.7 7.2 6.7 6.1 28.9 Total 5.0 7.3 −2.5 −13.9 −25.6 −29.7 Negative values are cost reductions. Column and row totals may not be exact due to rounding. FY08 begins with December 2007. 2. Major Cost Drivers Table 3 shows the major cost drivers for each food package; provisions listed do not reflect total food costs and savings. Total costs are for FY08-FY12 and have not been adjusted for the rule's phased implementation. Table 3.—Major Cost Drivers of WIC Food Packages Food package Major cost drivers (2008-2012) I • Formula is reduced for partially breastfed infants and eliminated for fully breastfed infants (−$172 million post rebate). II • Formula is reduced for fully formula and partially breastfed infants and is eliminated for fully breastfed infants (−$516 million post rebate). • Juice is eliminated for all infants (−$163 million). • Infant fruits and vegetables are added along with infant meats for fully breastfed infants (+$1,117 million). III Package III recipients are eligible for foods in the other packages. Under the interim rule, nearly 76% of Package III recipients are infants, and 24% are children; fewer than 1% are women. (+$62 million). IV • Juice is reduced (−$930 million). • Milk is reduced (−$895 million), • Cheese is reduced (−$559 million). • Eggs are reduced (−$215 million). • Whole grains added (+ $703 million). • $6 cash-value instrument for fruits and vegetables is added (+ $1,314 million). V • Juice is reduced (−$305 million). • Cheese is reduced (−$219 million). • Milk is reduced (−$219 million). • Beans are increased (+$113 million). • Milk substitutions are added (soy beverage and tofu) (+$180 million). • $8 cash-value instrument for fruits and vegetables is added (+$486 million). VI • Milk is reduced (−$166 million). • Juice is reduced (−$124 million). • Cheese is reduced (−$99 million). • $8 cash-value instrument for fruits and vegetables is added (+$272 million). VII • Juice is reduced (−$124 million). • Milk is reduced (−$75 million). • $10 cash-value instrument for fruits and vegetables is added (+$175 million). Negative values (−) are cost reductions, positive values (+) are cost increases. There are a total of $581 million in increases and $239 million in decreases that are not reflected in this table. 3. Fruit and Vegetable Option Due to the seasonal fluctuation in price and availability of fresh fruits and vegetables, and the inability to purchase them in uniform weight units, it is difficult to set quantity terms for fruits and vegetables and still estimate the cost of the WIC food packages. In order to accurately capture the cost of providing fresh fruits and vegetables in WIC Food Packages III-VII, the interim rule includes fruit and vegetable vouchers. Due to the administrative ease of implementation, the IOM recommended cash-value instruments be issued. 24 The IOM also recommended that states provide fruit and vegetable vouchers at the level of $10 per month for women and $8 per month for children. However, to achieve cost neutrality with the changes, FNS set the vouchers at the level of $8 per month for pregnant, partially breastfeeding and postpartum women and $6 per month for children in the year in which the food package revisions take effect. Fully breastfeeding women receive the recommended $10 voucher as part of WIC's breastfeeding promotion initiatives. Vouchers will be adjusted for inflation. The effects of inflation will be accrued annually, but not realized until the cumulative increase in the CPI is sufficient to raise the voucher's value by a dollar. Inflation is measured as the change in the Consumer Price Index

(CPI)for fresh fruits and vegetables, as detailed in the interim rule. 24 IOM, p. 172 4. Cost Estimate Methodology Overview The impacts of the interim rule on Federal expenditures are projected by comparing current policy to the interim rule with regard to total food costs. (Administrative funds are excluded; as noted above, no increase in funds will be provided to States or local clinics to implement this rule.) For both current and new rules, food costs are calculated as the sum of the aggregate annual expenditures on each available food package. These expenditures are calculated separately as the product of: • Participants—the number of women, infants, and children who receive each WIC food package; • Food Prescriptions—the specific types and quantities of food contained in each package distributed to WIC participants; and • Food Prices—the cost of the food items contained in WIC food packages. The data sources and assumptions used in projecting each of these elements are summarized briefly here. Greater detail is provided on the pages that follow. i. *Participation* —Participation statistics are remitted by State WIC agencies to FNS on a monthly basis. These are the product of routine recordkeeping by WIC clinics. They include counts of the number of women, infants, and children who receive WIC services. FNS collects additional program-relevant participant demographic characteristics such as age and life stage data through biennial data collections from WIC State agencies, as well as supplemental data on current breastfeeding practice. Participants are distributed as recipients of specific food packages under the current and new rules. Growth in program participation is based on projection of historical participation figures alone. ii. *Prescriptions* —FNS gathers detailed information on the amount of food prescribed to individual WIC participants through the same survey of WIC providers that serves as FNS's source for participant demographics. FNS uses these current prescription records, plus a set of explicit assumptions about participant preferences, to generate prescription totals for each of the foods in the interim rule's revised packages. iii. *Prices* —FNS tabulated average prices for each of the foods contained in the current and revised food packages from AC Nielsen's calendar year 2005 Homescan dataset. The final prices used in the cost estimate are these tabulated figures, adjusted for inflation and for rebates negotiated with infant formula manufacturers. FNS has posted these participation, prescription, and price figures on its Web site ( *http://www.fns.usda.gov* ), in Microsoft Excel format. Separate figures are given for each of the current and proposed food packages, and for each of the five fiscal years 2008 through 2012. The posted data will permit interested parties to reproduce the results of the cost estimate presented here. FNS encourages interested parties to examine the spreadsheet after reading the more detailed methodology that follows. 25 25 Additional information on the posted data, or on any other aspect of this cost estimate, is available from FNS on request. a. Food Package Costs i. Prescriptions FNS's primary data source for participant prescription data is its 2002 WIC Participant and Program Characteristics (“PC2002”) dataset. PC2002 is the eighth in a series of biennial reports and datasets on WIC participant and program characteristics. PC2002 employs the reporting system developed by FNS in 1992, which compiles key features of WIC participant information from State WIC agencies. The current system for reporting participant data is based on the automated transfer of an agreed upon set of data elements held in State management information systems. As part of the documentation needed to process the WIC PC participant data, each State also provides a food package code list which shows types and amounts of WIC food prescribed along with the State coding scheme. PC2002 summarizes demographic characteristics of WIC participants nationwide as of April 2002, along with information on participant income and nutrition risk characteristics. PC2002 contains information on a near-census of WIC enrollees for whom food benefits were made available in WIC management information systems in April 2002. 26 The dataset and the report's tabulations are based on over 8 million records. 27 26 For the month of April 2002, each State WIC agency was required to submit MDS data on a census of its WIC participants. All but 4 of the eighty-eight State WIC agencies (Mississippi, Choctaw Nation (OK), Eastern Shoshone and Rosebud Sioux) were able to provide sufficient data for tabulation in PC2002. 27 Fewer participants—approximately 7.5 million—actually picked up their vouchers in April 2002 and were counted according to WIC regulations as participants for WIC administrative funding purposes. FNS used prescription data from the PC2002 dataset to establish a baseline food cost and to estimate the costs of the package revisions. Actual participant-level prescriptions provide a useful starting point for this analysis. Data at the participant level captures the preferences and dietary restrictions of the current WIC population. Assuming little change in the distribution of the WIC population by life stage, food preference, or supplemental dietary need over the short term, the 2002 prescription data offers the best opportunity for estimating likely prescription amounts under the interim food package rule. 28 FNS estimated participant-specific prescription amounts for each of the foods in the packages other than infant formula. In an effort to reflect the interim rule's requirements that

(1)participants be issued prescriptions at the maximum level per package, unless that level for one or more items is medically contraindicated, or the participant declines to accept the item; and

(2)States may no longer adjust or “tailor” packages categorically, but that WIC professionals may do so, the following assumptions guided this analysis: 29 28 Due to insignificant differences in the PC2002 and PC2004 data, this analysis was not updated with the PC2004 dataset. 29 The description that follows is a simplification of the process used to develop the estimated prescriptions. • For foods that are part of both the current WIC packages and the revised packages: • WIC participants currently prescribed none of that food will continue to be prescribed none (presumed medically contraindicated). • If the participant's current prescription exceeds the interim rule's maximum for the item, then the participant will be prescribed the new maximum amount. • If the participant's current prescription is less than the maximum amount allowed by the state under current rules, and less than the interim rule's amount, then the participant's prescription will remain unchanged. • For foods newly added to the WIC packages by the interim rule: • Generally, prescription rates are set to observed rates for comparable foods already contained in the WIC packages. 30 30 For example, the prescription rates for whole grain bread and bread substitutes are set to the observed prescription rates for cereal. The April 2002 Food Package IV cereal prescription rate was applied to Package IV bread prescriptions; the average Package V and Package VII cereal prescription rate was used to estimate Package V and Package VII bread prescriptions. • Foods newly added to the WIC packages as substitutes for standard WIC foods were prescribed to a subset of the WIC population equal to the percent of all low income U.S. households that currently purchase those items. 31 For example, market consumption data indicates that about 3% of U.S. households with WIC-eligible incomes purchased tofu, so 3% of WIC participants are assumed to be prescribed tofu. 32 Participants prescribed one of the new substitutes will be provided with the maximum required under the interim rule given any other substitutions allowed. 31 Market consumption data is based on 2003 AC Nielsen Homescan survey data. 32 This method of identifying general consumer preferences for particular items cannot be used to estimate the share of the infant population that consumes fresh bananas. It is assumed, then, that infants will be prescribed bananas as a substitute for jarred infant food fruits and vegetables at the average prescription rate for all foods across all food packages. • Fruit and vegetable vouchers are assumed to be prescribed to all participants at the full amount. This methodology tends to produce prescription estimates that are at or near the maximum quantities specified in the revised packages. (See Table 4.) ii. Infant Formula and Rounding In this analysis, infant formula and infant foods were treated slightly differently than the other foods. Using a micro-simulation program with PC2002 data to model prescription amounts for infant formula and foods would not account for “rounding up”. Rounding up refers to the ability of state agencies to round up to the next whole container to provide the maximum infant formula allowance. State agencies may only include an option to round-up in infant formula contracts renewed on or after October 1, 2004. The interim rule extends this rounding option to infant foods (cereal, fruit and vegetables, and meat). Since the PC2002 data do not reflect the costs of states rounding up, the cost estimates of the current and interim rule packages use a different approach to factor in the cost of states rounding up. Given current container sizes, rounding up is only required when issuing powder infant formula and infant fruit and vegetables. The maximum allowances for liquid concentrate infant formula, ready-to-feed infant formula, infant cereal and infant meat are evenly divisible by whole containers. To capture the effect of rounding, the following assumptions have been made: • Current Food Packages I and II • Estimated infant formula prescription amounts for Packages I and II incorporate rounding because the estimated reconstituted amounts fall below the package maximum. Estimated prescribed amounts for Packages I and II are set at the maximum amounts of 806 reconstituted liquid ounces for liquid concentrate and ready to feed infant formulas; for powder infant formula the current 8 pound limit is used. • The reconstituted fluid ounces from powder infant formula is a weighted average of the powder container yield for the three infant formula brands with which state agencies have rebate contracts: Mead Johnson, Ross and Nestle (as determined by State agency contracts as of February 2007.) 33 33 The primary DHA/ARA enhanced powder formulas prescribed by WIC clinics for each of the manufacturers was used in computing the weighted average. • Total infant formula allowance for each package is weighted by the percentage of infants receiving each of the three forms (liquid concentrate, ready to feed, and powder) as distributed in the WIC participant characteristic data set. • Interim Food Packages I and II • Infant Formula: • All packages are set at the maximum monthly allowance for liquid concentrate, ready to feed and powder infant formulas as detailed in the interim rule. • Powder infant formula is rounded up to meet the Full Nutritional Benefit (the maximum monthly allowance of reconstituted liquid concentrate), but to not exceed the maximum monthly powder infant formula limit. • The reconstituted fluid ounces from powder infant formula is a weighted average of the powder container yield for the three formula brands with which state agencies have rebate contracts: Mead Johnson, Ross and Nestle (as determined by state agency contracts as of February 2007). 34 34 The primary DHA/ARA enhanced powder formulas prescribed by WIC clinics for each of the manufacturers was used in computing the weighted average. • Interim Food Package I BF/FF-A assumes 100 percent powder infant formula. This is consistent with IOM recommendations. • Total infant formula allowance for each package is weighted by the percentage of infants receiving each of the three forms (liquid concentrate, ready to feed, and powder) as distributed in the WIC participant characteristic data set. • Infant Foods: • Only Package II has infant foods. Container sizes are based on IOM assumptions: infant fruits and vegetables amounts are determined using Gerber container sizes weighted over the 6 month package period. 35 35 The prescription rates for infant cereal, fruit and vegetables, and meat are set to the average prescription rate of juice across all of the women's food packages. The estimate assumes that no state will authorize rounding of infant foods. • Bananas are allowed to be substituted for infant fruit at the rate of 2 pounds per 16 ounces of fruit. The interim package cost estimate assumes 1.8 pounds of bananas as substitution. The interim rule requires State agencies to issue at least the full nutritional benefit of infant formula but not more than the maximum monthly allowance for the food package category and infant feeding option. However, rounding up to the whole container to meet the full nutritional benefit under the interim rule, when compared to the maximum monthly allowance under the current rule, provides more containers per month, which in turn results in higher costs. In addition, under both the current and interim packages, the round up provision is assumed to apply in all States at full implementation beginning in FY08. Therefore, this analysis provides the most conservative estimate of the additional cost due to rounding (assuming container sizes do not change), as there is no way to accurately determine which States will elect to include a round up provision in their infant formula rebate contract and opt to round up going forward. iii. Redemption rates Tables 4 and 5 show the maximum amount per food category and estimated average prescribed amounts used to calculate costs for the food packages under the interim rule and under the current rule, respectively. Each table includes the individual food package component and its corresponding unit of measurement. WIC foods are provided by quantity, except for the fruit and vegetable voucher. As stated in the interim rule, participants will be given a fruit and vegetable voucher with a fixed dollar value which can be used to purchase fruit and vegetables. Because the fruit and vegetable voucher provides WIC benefits in a different form than is currently used, different redemption behavior is to be expected. Therefore, in developing a cost estimate for the rule, it is assumed that these vouchers will be redeemed at a rate of 87.5 percent, which is consistent with an evaluation of a WIC fruit and vegetable intervention in Los Angeles in 2004. 36 Per participant, a redemption value of $5.25 for children, $7.00 for pregnant, partially breastfeeding and postpartum women, and $8.75 for fully breastfeeding women was included in the cost of the respective food package. 36 Herman, Dena and Harrison, Gail, “Are Economic Incentives Useful for Improving Dietary Quality among WIC participants and their Families?” ERS, USDA, 2004. All other WIC foods are assumed to be redeemed at a 100% rate. The assumption of 100% redemption rates for other WIC foods reflects research findings which indicate that redemption rates for current WIC foods are high and vary little by food item (ranging from 94-99 percent). 37 Variation in the quantity of foods purchased by participants is reflected in the prescription rates. Thus a simplifying assumption of 100 percent redemption rates was used for WIC foods prescribed by quantity. 37 Food and Nutrition Service, U.S. Department of Agriculture, “National Survey of WIC Participants”, October 2001. Table 4.—Prescription Estimates Under Interim Rule 38 Food package Units 39 Maximum amount per food category 40 Estimated average prescribed amount Infants: Food Package I I-FF-A (0-3.9 mo): Formula (post-rebate) reconstituted fluid oz 806 842.65 I-FF-B (4-5.9 mo): Formula (post-rebate) reconstituted fluid oz 884 931.37 I-BF/FF-A (0-0.9 mo): Formula (post-rebate) 41 reconstituted fluid oz 104 0.00 I-BF/FF-B (1-3.9 mo): Formula (post-rebate) reconstituted fluid oz 364 390.14 I-BF/FF-C (4-5.9 mo): Formula (post-rebate) reconstituted fluid oz 442 470.66 I-BF-A (0-3.9 mo): Formula (post-rebate) reconstituted fluid oz 0 0.00 I-BF-B (4-5.9 mo): Formula (post-rebate) reconstituted fluid oz 0 0.00 Infants: Food Package II II-FF (6-11.9 mo): Formula (post-rebate) reconstituted fluid oz 624 656.66 Cereal oz 24 20.10 Baby fruits & vegetables oz 128 105.37 Bananas lb 1.80 II-BF/FF (6-11.9 mo): Formula (post-rebate) reconstituted fluid oz 312 355.32 Cereal oz 24 20.93 Baby fruits & vegetables oz 128 105.37 Bananas lb 1.80 II-BF (6-11.9 mo): Cereal oz 24 22.27 Baby fruits & vegetables oz 256 225.03 Bananas lb 1.80 Infant food meat oz 77.5 73.06 Children: Food Package IV IV-A (1-1.9 yrs): Juice oz 128 127.59 Milk (whole) qt 16 13.01 Cheese lb 0.96 Cereal oz 36 34.39 Eggs doz 1 1.00 Whole grain bread lb 2 1.22 Other grains lb 0.69 Beans, dried 42 lb 1 0.30 Beans, canned oz 19.54 Peanut butter oz 6.27 Fruit and vegetable voucher. 43 voucher ($) 6.00 5.25 IV-B (2-4.9 yrs): Juice oz 128 127.59 Milk, fat-reduced qt 16 13.01 Cheese lb 0.96 Cereal oz 36 34.39 Eggs doz 1 1.00 Whole grain bread lb 2 1.22 Other grains lb 0.69 Beans, dried lb 1 0.30 Beans, canned oz 19.54 Peanut butter oz 6.27 Fruit and vegetable voucher. 43 voucher ($) 6.00 5.25 Women: Food Package V V: Juice oz 144 143.40 Milk, fat-reduced qt 22 16.90 Soy beverage qt 1.66 Tofu lb 0.05 Cheese lb 0.97 Cereal oz 36 35.09 Eggs doz 1 1.00 Whole grain bread lb 1 0.63 Other grains lb 0.35 Beans, dried 44 lb 1 0.60 Beans, canned oz 38.63 Peanut butter oz 18 13.41 Fruit and vegetable voucher. 43 voucher ($) 8.00 7.00 Women: Food Package VI VI: Juice oz 96 95.54 Milk, fat-reduced qt 16 11.68 Soy beverage qt 1.29 Tofu lb 0.02 Cheese lb 0.95 Cereal oz 36 34.70 Eggs doz 1 0.95 Beans, dried 44 lb 1 0.23 Beans, canned oz 14.69 Peanut butter oz 9.06 Fruit and vegetable voucher. 43 voucher ($) 8.00 7.00 Women: Food Package VII VII: Juice oz 144 143.64 Milk, fat-reduced qt 24 17.51 Soy beverage qt 1.46 Tofu lb 0.01 Cheese lb 1.60 Cheese lb 1 1.00 Cereal oz 36 35.87 Eggs doz 2 1.98 Whole grain bread lb 1 0.63 Other grains lb 0.35 Canned fish oz 30 Tuna oz 22.44 Salmon, sardines, mackerel oz 6.11 Beans, dried 44 lb 1 0.60 Beans, canned oz 38.63 Peanut butter oz 18 13.41 Fruit and vegetable voucher. 43 voucher ($) 10.00 8.75 38 The only significant change to Food Package III in the interim rule is the proposed addition of foods to these recipients' packages when their medical circumstances allow it. The PC2002 data set indicates that about 1 percent of WIC participants receive Food Package III. FNS assumes that half of them will be able to and will choose to receive all of the other foods available to them under the proposed rule. Therefore, we do not calculate prescription rates for Food Package III. 39 Units are expressed in: fluid ounces (fluid oz); ounces (oz); pounds (lb); quarts (qt); and, dozens (doz). 40 Infant formula amounts are expressed in the full nutritional benefit amount of reconstituted liquid concentrate required for that age group. The interim rule details the maximum formula amounts allowed for each form of infant formula. 41 Although partially breastfed infants will be allowed up to 104 reconstituted fluid ounces in the first month following birth in the interim rule, this analysis does not estimate a prescribed amount. For more discussion, see Section E, Item 3. 42 Total ounces for dried beans, canned beans and peanut butter exceed 1lb because participants can substitute 64 ounces of canned beans or 18 ounces of peanut butter for 1lb of dried beans. 43 Prescribed amount for fruit and vegetable vouchers is the redemption rate as discussed in 3a

(iii)within this section. 44 Total ounces for dried and canned beans exceed 1lb because participants can substitute 64 ounces of canned beans for 1lb of dried beans. Table 5.—Prescription Estimates for Current Food Packages Food package Units 45 Maximum amount per food category Estimated average prescribed amount Infants: Food Package I I—Fully breast-fed: Formula reconstituted fluid oz 806 79.58 I—Partially breast-fed: Formula reconstituted fluid oz 806 546.55 I—Fully formula-fed: Formula reconstituted fluid oz 806 906.33 Infants: Food Package II II—Fully breast-fed 4-6.9 mo: Formula reconstituted fluid oz 806 77.38 Juice oz 96 34.09 Cereal oz 24 20.63 II—Partially breast-fed 4-6.9 mo: Formula reconstituted fluid oz 806 613.76 Juice oz 96 53.80 Cereal oz 24 16.60 II—Fully formula-fed 4-6.9 mo: Formula reconstituted fluid oz 806 906.33 Juice oz 96 41.93 Cereal oz 24 16.99 II—Fully breast-fed 7-11.9 mo: Formula reconstituted fluid oz 806 77.12 Juice oz 96 81.15 Cereal oz 24 22.28 II—Partially breast-fed 7-11.9 mo: Formula reconstituted fluid oz 806 637.89 Juice oz 96 69.30 Cereal oz 24 21.08 II—Fully formula-fed 7-11.9 mo: Formula reconstituted fluid oz 806 906.33 Juice oz 96 76.42 Cereal oz 24 20.27 Children: Food Package IV IV: Juice oz 288 232.77 Milk qt 24 16.58 Cheese lb 1.57 Cereal oz 36 34.39 Eggs doz 2.5 1.83 Beans, dried lb 1 0.61 Peanut butter oz 6.27 Women: Package V V: Juice oz 288 267.83 Milk qt 28 20.94 Cheese lb 1.84 Cereal oz 36 35.09 Eggs doz 2.5 1.99 Beans, dried lb 1 0.55 Peanut butter oz 7.29 Women: Package VI VI: Juice oz 192 185.54 Milk qt 24 17.15 Cheese lb 1.65 Cereal oz 36 34.70 Eggs doz 2.5 1.78 Women: Package VII VII: Juice oz 336 319.32 Milk qt 28 22.28 Cheese as milk substitute lb 1.65 Cheese lb 1 1.00 Cereal oz 36 35.87 Eggs doz 2.5 2.00 Beans, dried lb 1 1.20 Peanut butter oz 18 13.41 Tuna oz 26 24.75 Carrots lb 2 1.99 45 Units are expressed in fluid ounces (fluid oz), ounces (oz), pounds (lb), quarts (qt), and dozens (doz). iv. Food Prices The price data used in this analysis is based primarily on tabulations from the calendar year 2005 AC Nielsen Homescan dataset. 46 Homescan data is captured by AC Nielsen panel members who record their purchases at home with handheld scanners. This type of panel data is well-suited to the WIC food package analysis. Unlike data gathered from point of sale scanners, panel data is potentially more comprehensive; it is able to capture purchases from retailers of every size and type, including supermarkets, convenience stores, drug stores, and vendors who lack checkout scanning equipment. 47 In addition, demographic information collected from Homescan panelists allows FNS to distinguish shoppers with WIC-eligible incomes from the rest of the population. 46 Prices displayed in Table 6 are inflated to FY 2006 levels using Bureau of Labor Statistics CPI estimates. 47 Homescan data also captures purchases of non-UPC coded (non-scannable) random weight items such as fresh produce. Homescan panels are geographically and demographically stratified random samples of individuals weighted to represent all U.S. households. A few of the demographic strata used by Nielsen are household size, household income, household race, and several characteristics of the head of household. Nielsen monitors and evaluates the performance of panelists, and data collected by panelists undergo various internal consistency checks. (No commenters on the proposed rule raised questions or identified potential limitations with regard to AC Nielsen Homescan data.) FNS had access to two Homescan panel samples. The 39,000 panelists in the first sample record calendar year 2005 purchases of all scannable products. A smaller subsample of 8,200 panelists record purchases of all items, including random weight, non-UPC-coded items. Most of the foods in the current and interim rule food packages are UPC-coded, standard-weight, pre-packaged (i.e., scannable) items. For that reason, most of the prices computed by FNS are taken from purchases recorded by the larger Homescan panel. FNS focused its analysis on purchases by individuals with WIC-level incomes. FNS generated its own subsamples of panelists whose reported household size and annual income indicate that they are WIC income-eligible. The income-eligible working dataset drawn from the larger of the two Homescan panels (used for most of FNS's price computations) contains 8,400 panelists. The working dataset drawn from the smaller panel (used in few of FNS's price computations) contains 1,600 panelists. a. Computation of Average Prices For each of the food items in the current or interim packages, FNS computed the average price paid by households with WIC-eligible incomes. All prices are weighted by the aggregate volumes purchased by WIC-eligible product variety, container size, flavor, brand, etc. Product descriptions captured by Nielsen sometimes lack the detail necessary to separate WIC-eligible items from non-eligible items. For this reason, the selection of products from the Nielsen datasets necessitates some compromise. The average prices computed by FNS and a brief description of FNS's product selection criteria are shown in Table 6. Food prices obtained from AC Nielsen Homescan data are inflated to FY 2006 levels with CPI estimates published by Bureau of Labor Statistics. Food items or category-specific inflation estimates were used, when available. For years after FY 2006, food costs are inflated by the Office of Management and Budget's November, 2006 Thrifty Food Plan

(TFP)index except for the fruit and vegetable vouchers which are inflated by the USDA's agricultural baseline projections for retail fruit and vegetable prices. (See Tables B and C in Appendix A for more detail.) In each case, prices are computed only for products in container sizes consistent with current WIC regulations, typical state agency requirements, or the interim rule. Products identified as organic were excluded; states typically disallow organic varieties for cost reasons. FNS also adjusted infant formula prices to account for State agencies prescribing infant formulas enhanced with DHA/ARA, which tend to cost WIC more than non-enhanced infant formulas. This analysis provides a conservative estimate that assumes all states will issue enhanced infant formulas exclusively during the five-year period. 48 48 This assumption is based on the percentage of States exclusively issuing enhanced formula as of the February 2007 rebate contract summary of 94%. Based on current trends, FNS believes the percentage of States exclusively issuing enhanced formula will be 100% at the time of implementation. Table 6.—WIC Foods: Food Item, Selection Criteria, Units, and Prices Per Unit Food item Retail sales database selection criteria Units Price per unit (inflated to FY06) Infant formula (post rebate): 49 Powdered Enhanced formulas 50 in powdered, liquid concentrate, and ready-to-feed forms oz $0.0312 Weighted average of all forms. 51 oz 0.0331 Infant cereal (post rebate) Dry grains without added fruit or other flavors oz 0.125 Infant food: Infant fruit and vegetables Any texture; plain fruits or vegetables oz 0.122 Infant food meat All plain meat varieties oz 0.346 Bananas Fresh. lb 0.456 Milk: Whole Fresh dairy milk only, 1/2 gallon or gallon containers. Reduced fat includes skim milk and milk identified as 2% or lower milk fat qt 0.767 Reduced fat qt 0.708 Cheese Processed American and domestic natural cheddar, Colby, mozzarella, brick, Monterey jack. Sliced or un-sliced varieties lb 3.292 Yogurt Quart sized containers and larger. Plain, vanilla, and fruit flavors qt 2.068 Tofu Plain varieties lb 1.467 Soy beverage Half gallon or larger sizes. Plain varieties. 52 qt 1.370 Juice Apple, grape, orange, grapefruit, tomato. Unsweetened 100% juice oz 0.032 Adult cereal Weighted average of cereals commonly prescribed by state WIC agencies and whole-grain varieties. Hot or ready-to-eat oz 0.159 Eggs Large or medium, white. One-dozen containers only doz 0.931 Beans: Dry Most varieties, excluding string beans and immature peas. Not mixed with other foods lb 0.805 Canned oz 0.037 Peanut butter All forms and varieties. Not mixed with jelly oz 0.094 Whole-grain bread Wheat or grain bread lb 1.422 Brown rice Instant or regular lb 1.178 Tuna Chunk light, canned oz 0.101 Other canned fish Salmon, sardines and mackerel, canned oz 0.114 Carrots Fresh, frozen, canned lb 0.953 49 The average prices computed for infant formula are based on a range of container sizes commonly prescribed by WIC clinics. Formula prices, unlike the prices computed for other products in this analysis, are based on purchases by all individuals, not just those with WIC-eligible incomes. This has little consequence on the average price since more than half of the infant formula purchased in the U.S. is purchased by WIC participants. 50 The term “enhanced formulas” means formulas that have been enhanced with two fatty acids, DHA and ARA. 51 The weighted average price is used throughout this analysis except when pricing the value of formula prescriptions, under the interim rule, for partially breastfeeding infants age 0-3 months. For that one group, the interim rule recommends the prescription of powder alone. 52 The price reflects purchases by individuals at all income levels. The dataset contained too few sample records when limited to purchases by individuals with WIC-eligible incomes. v. Participant Projections For this analysis, FNS makes the straightforward assumption that overall WIC participation will grow at a fixed 2.08% annual rate from February 2007 through the end of fiscal year 2012. 2.08% is a simple average of the annual observed rates of growth for each of the seven years that ended in January 2007. The participant data used to generate this growth rate is remitted by the States to FNS on a monthly basis. Participant data are reviewed for possible collection, transmission, or keying errors, but are otherwise unadjusted by FNS. The participant growth assumption used in this analysis is intended to illustrate the potential cost impacts of the revised food package over time and should not be construed as reflecting any policy or projection of future WIC participation. Consistent with the IOM assumptions, we do not assume any changes in participation under the interim rule due to potential participants finding the revised package more or less attractive. (For more detail on participation levels by food package see Tables D and E in Appendix A.) Many of the package changes were intended to encourage breastfeeding. However, it is important to note that this analysis does not provide an estimate of the increase in the number of breastfed infants or the additional length of time that infants will be breastfed. Due to the complex set of factors (demographic, social, environment, clinical, etc.) that influence breastfeeding duration, we are unable to estimate the number of infant/mother pairs that will switch food packages as their feeding practices change. This is consistent with the analysis provided by IOM. The assumption of no change in breastfeeding patterns yields the most conservative cost estimate, as the net impact of increases in breastfed infants and breastfeeding women participants reduces the costs of this proposal. IOM conducted a sensitivity analysis by simulating possible shifts in participation rates. Shifting infant/mother pairs from the fully formula-fed package to the breastfeeding packages has the effect of moving infant/mother pairs from the most expensive set of packages to less expensive ones. A constant shift of 30 percent for one to 11 months of age from partial to full breastfeeding and a smaller range of shifts from full formula feeding to full breastfeeding (with an appropriate shift in the mother's classification) decreased the average package cost by nearly two percent. 53 53 See IOM, p. 140. vi. Phased Implementation The analysis assumes the rule takes effect in December 2007 (FY08). During the phase-in period, State agencies will be required to issue food benefits based on either the new food packages or current food packages but cannot combine the two. State agencies may also phase-in new food packages on a participant category basis. Based on comments from State and local agencies, the interim rule's phased-in period has been revised to reflect an 18-month period, six months longer than the implementation period in the proposed rule. In the interim rule, the elimination of juice from the infant food packages is phased-in over 18 months, rather than six months as stated in the proposed rule, from publication of the rule. All phase-in effects are reflected in the cost estimates contained in Table 2. This analysis assumes that the remaining provisions of the rule will be phased-in over the course of 18 months beginning December 2007. It is assumed, as above, that States will implement the provisions of the rule throughout the phase-in period; the effective rate of implementation is averaged over the course of 18 months. 54 The rule's phase-in schedule reduces total costs in FY 2008 by $11.1 million. FY 2009 costs are reduced by an estimated $1.1 million. 54 If the phase-in rate increases linearly, the rule would not be fully effective until July 2009. As a rough approximation, it is assumed that the effective rate of implementation of all provisions throughout FY 2008 averages 31 percent, with the remainder realized in the first eight months of FY 2009. vii. State Cost Variation This analysis is based on national average prescription and price data, which indicates that program-wide, the changes are cost neutral. States may vary somewhat in their implementation experiences, depending on how closely their prescription practices and prices correspond to the national averages. WIC funding rules help address these implementation issues. The food funding formula provides mechanisms for transferring funds from States which are not fully utilizing their grants to those with need for additional funding, and these mechanisms have been successfully used in the past to address variations in States' funding needs. b. Administrative Costs State agencies and local WIC providers will incur some new costs to implement the rule. A total of six State agencies provided comments on the proposed rule that specifically addressed costs associated with implementation. In general, these States believed that additional nutrition services and administration

(NSA)funds would be needed to update and enhance MIS systems, train staff, participants and vendors, and update food lists. However, none of these commenters attempted to quantify their expected costs. Many of the costs of implementation are similar in type to the routine recurring costs of operating a WIC program. These include training WIC clinic and administrative staff, and the periodic review and updating of WIC-approved food lists to assist vendors with their own staff training. Much of the training-related cost that State and local agencies will incur as a result of the rule will therefore displace similar recurring expenses during the phase-in period. Other costs, such as modifying MIS systems, are non-routine expenses tied exclusively to the transition to a new set of food packages. However, MIS systems vary greatly across the States, and the effort needed to modify these systems will vary as well. FNS is not in a position to assess the level of work faced by State and local agencies. As a result, the cost of modifying State MIS systems cannot be estimated. Despite their concerns, States were overwhelmingly supportive of the proposed changes; one State comment stated directly the judgment that the benefits from implementing the new packages will outweigh the effort needed to implement the changes. FNS believes that State agencies and local WIC providers will be able to absorb the burden associated with implementing this rule within current NSA funds. State and local agencies have substantial flexibility in how they spend their NSA funds and may need to reprioritize or postpone some initiatives to undertake the implementation activities associated with this rule. Given the extremely positive response that this rule has received within the WIC community at both the State and local levels, we fully expect that implementation will be a priority. E. Uncertainties The estimate developed above is sensitive to changes in several key assumptions. A few of the most significant are discussed here. 1. Price Volatility in the Dairy Market Instability in dairy prices over the last several years presents a major element of uncertainty in the cost estimate. However, the maximum amount of milk available in each of the food packages is reduced. The total amount of milk that can be replaced with more expensive substitutes has been reduced as well. These factors make the revised food packages less sensitive to dairy price fluctuations than the current WIC packages. FNS examined the impact of a 10% increase and a 10% decrease in the price of milk and cheese. Since the amount of milk and cheese is being reduced in the interim packages, higher dairy prices would produce a net savings. That is, while higher dairy prices would increase the absolute cost of the interim rule's food packages, an equivalent dairy price increase would increase the absolute cost of the current rule's packages by an even greater amount. Because the increased cost is relatively smaller under the interim rule, a dairy price increase will reduce the cost of adopting the rule; the $29.7 million savings under our baseline assumptions would become a $222.5 million savings. Similarly, lower dairy prices would increase the cost of adopting the interim rule. The impact of these price changes is summarized in the following table: Table 7.—Projected Cost of WIC Food Package Revisions, Assuming a 10% Increase or a 10% Decrease in Dairy Prices [In $ millions] FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Cost/Savings of Rule with 10% Increase in Dairy Prices -$5.8 -$30.8 -$48.4 -$61.8 -$75.7 -$222.5 Cost/Savings of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference Between Base Assumption and 10% Price Increase 10.8 38.2 45.9 47.9 50.0 192.8 Cost/Savings of Rule with 10% Decrease in Dairy Prices 15.8 45.5 43.3 34.0 24.4 163.1 Cost/Savings of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference Between Base Assumption and 10% Price Decrease -10.8 -38.2 -45.9 -47.9 -50.0 -192.8 Negative values are cost reductions. Differences may not be exact due to rounding. 2. Assumed Preference for Soy Beverage FNS estimates that as many as 10% of women will request soy beverage in place of liquid milk, if provided the choice. 55 The IOM cites high rates of lactose maldigestion and low rates of cultural acceptability of milk among African American and Asian women as important factors in its decision to introduce substitutes for milk. 56 African American women are represented in the WIC population at a level disproportionate to their share of the general population. In part for that reason, it is appropriate to assume a WIC participant preference for soy beverage at or near the upper range of estimates of soy beverage consumption in the U.S. as a whole. And because WIC participants may choose freely between milk and the more expensive soy substitute, without regard to cost, a natural response is consumption at a rate above the rate of those whose choice between the two products has personal cost impact. 55 AC Nielsen Homescan data indicate that approximately 10% of households with WIC-eligible incomes purchased some type of soy beverage during FY 2003. Soy beverage cannot be identified precisely in the AC Nielsen dataset. The 10% consumption figure is based on a broad product definition that includes soy beverage varieties that are not WIC-eligible under the interim rule. FNS sought to identify women who might request plain soy beverage if it is offered, cost-free, as a milk substitute. The estimate developed here assumes that this group will include some women who are current consumers of more popular soy beverage varieties. 56 IOM, p. 119. FNS determined which women in the 2002 WIC prescription dataset were provided neither milk nor cheese. Those individuals, as a group, are assumed to be the WIC participants most inclined to request a prescription of soy beverage in place of milk. FNS' simulation model prescribes an amount of soy beverage to those individuals equal to the maximum allowed under their respective food packages. The program then substitutes soy beverage for the existing milk prescriptions of other WIC participants to the extent necessary to reach the 10% participant target. The program prescribes cheese and tofu before soy beverage; it does not replace the prescription of those milk substitutes with soy beverage. IOM took a similar approach in developing its cost estimate; it assumed that soy beverage would replace 10% of liquid milk prescriptions. In IOM's analysis, 8.7% of all milk and milk substitutes prescribed to women is in the form of soy beverage. FNS' methodology, which incorporates the more detailed data available from PC2002, results in a somewhat lower 7.6% substitution rate for soy beverage. Precise data on which to base a soy beverage consumption rate for adult women is not available; it is not known whether consumption is appreciably higher or lower among women than among the population generally. For these reasons, the cost of the interim rule has been re-estimated using two alternate assumptions. If soy beverage is prescribed to only 5% of women, the average Package V, VI, and VII soy beverage substitution rate is 3.8%. Conversely if soy beverage is prescribed to approximately 15% of women, the average Package V, VI, and VII soy beverage substitution rate is 11.4%. Given the high cost of soy beverage relative to milk, this uncertainty would have cost implications. Table 8.—Projected Cost of WIC Food Package Revisions, Assuming 5% or 15% of Women Are Prescribed Soy Beverage [in $ millions] FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Cost/Savings of Rule with alternate 5% prescription rate $1.5 -$4.9 -$17.2 -$29.2 -$41.6 -$91.4 Cost/Savings of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference Between Base Assumption and 5% Prescription Rate 3.5 12.2 14.7 15.3 16.0 61.6 Cost/Savings of Rule with alternate 15% prescription rate 8.4 19.5 12.1 1.4 -9.6 31.9 Cost/Savings of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference Between Base Assumption and 15% Prescription Rate -3.5 -12.2 -14.7 -15.3 -16.0 -61.6 Negative values are cost reductions. Differences may not be exact due to rounding. 3. State option to provide formula for infants 0-0.9 months of age The proposed rule put forth three options for infant feeding within the first month of birth:

(1)Fully formula feeding;

(2)fully breastfeeding; or

(3)partially breastfeeding. The Proposed Rule did not allow formula to be provided for partially breasted infants under one month of age. This interim rule will allow partially breastfed infants in the first month of life to receive no more than 104 reconstituted fluid ounces of infant formula. Food Package V will be provided to mothers of these partially breastfeeding infants. As shown in Table 9, the low amount of formula provided to partially breastfeeding infants under one month of age and the difference in the women's packages provides a cost savings when infant/mother pairs move to the partially breastfeeding packages during the first month after birth. FNS does not know how many fully formula feeding and fully breastfeeding mothers would opt to partially breastfeed during the infant's first month. However, given that the monthly cost of the food packages for a partially breastfeeding pair is less than the cost of the packages for either a fully breastfeeding or fully formula feeding pair, even a relatively large shift to the partially breastfeeding packages does not threaten the overall cost neutrality of the interim rule. Table 9.—Combined Monthly Food Package Costs for Infant/Mother Pairs of Infants 0-0.9 Months, Assuming One Can of Formula for Partially Breastfeeding Infants in First Month Monthly food package costs (FY 2006) Mother Infant Pair Fully Formula Fed Feeding Pair $31.23 $27.90 $59.14 Partially Breast Fed Feeding Pair 40.09 3.25 43.34 Cost/Savings of Moving to Partially Breast Fed Packages $8.86 -$24.66 -$15.80 Fully Breast Fed Feeding Pair 51.30 0.00 51.30 Partially Breast Fed Feeding Pair 40.09 3.25 43.34 Cost/Savings of Moving to Partially Breast Fed Packages -$11.21 $3.25 -$7.96 4. Prescription Assumptions for Whole Grain Bread and Bread Substitutes Because whole grain bread and bread substitutes are new additions to the WIC food packages, FNS had to develop prescription assumptions for these foods without the benefit of historic prescription data. For purposes of this cost estimate FNS assumed that whole grain bread and bread substitutes would be prescribed to WIC participants at rates comparable to the observed prescription rates for breakfast cereal, the most closely related food in the current WIC packages. 57 For children's Package IV, FNS applied an observed cereal prescription rate of 95.4%. For packages V and VII, FNS applied an observed average rate of 97.7%. 57 Observed rates were taken from PC2002. Table 10 recomputes the cost effect of the interim rule under the alternate assumptions that the actual whole grain bread prescription rates for food packages IV, V, and VII will be as low as 90%, or as high as 100%. Table 10.—Projected Cost of WIC Food Package Revisions Assuming 90% and 100% Whole Grain Prescription Rates FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Cost/Savings of Rule with 90% Whole Grain Prescription Rate $2.6 $1.2 -$12.8 -$24.6 -$36.8 -$72.9 Cost/Savings of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference Between Base Assumption and 90% Prescription Rate $2.4 $8.5 $10.3 $10.7 $11.2 $43.1 Cost/Savings of Rule with 100% Whole Grain Prescription Rate 6.8 13.7 5.1 -5.9 -17.3 2.5 Cost/Savings of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference Between Base Assumption and 100% Prescription Rate -$1.8 -$6.4 -$7.7 -$8.0 -$8.4 -$32.3 5. Prescription Assumptions for Infant Food Fruits and Vegetables, and Infant Food Meat Jarred infant foods, like whole grain breads, are new additions to the WIC food packages. Without the benefit of historic prescription rates for these foods, FNS had to look elsewhere for a prescription assumption to use in its cost estimate. FNS considered and rejected infant fruit juice prescriptions as a proxy, despite the fact that the jarred food benefit is comprised primarily of fruits and vegetables. Infant juice prescriptions fall well below 100%, largely because states recognize that the current package maximums exceed amounts recommended by current nutrition science. FNS believes that the interim rule's infant foods will be prescribed at a much higher rate. For this reason, FNS assumes that the jarred infant food prescription rate will match the observed 94.3% prescription rate for fruit juice across WIC's women's food packages. 58 58 Because the estimate assumes no rounding up of jarred infant foods, the net average prescription rate is slightly less than 94.3% for baby food fruits and vegetables. The average prescription for baby food meat is a full 94.3%, however, because the maximum monthly allowance of 77.5 oz is evenly divisible by the most commonly marketed jar size. Table 11 recomputes the cost effect of the interim rule under the alternate assumptions that jarred infant food prescriptions will be as low as 90%, or as high as 100%. Table 11.—Projected Cost of WIC Food Package Revisions Assuming 90% and 100% Jarred Infant Food Prescriptions FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Cost/Savings of Rule with 90% Infant Food Prescription Rate $2.1 −$2.7 −$14.6 −$26.5 −$38.8 −$80.4 Cost/Savings of Interim Rule 5.0 7.3 −2.5 −13.9 −25.6 −29.7 Difference Between Base Assumption and 90% Prescription Rate 2.8 10.0 12.0 12.6 13.1 50.6 Cost/Savings of Rule with 100% Infant Food Prescription Rate 8.7 20.4 13.1 2.5 −8.6 36.0 Cost/Savings of Interim Rule 5.0 7.3 −2.5 −13.9 −25.6 −29.7 Difference Between Base Assumption and 100% Prescription Rate −3.7 −13.0 −15.6 −16.3 −17.1 −65.8 6. Changes in Current Food Package Sizes The current and interim rules specify maximum food allowances in units of weight or volume. Several comments on the Proposed Rule asked that food allowances be expressed in package units, such as number of jars or containers, or that maximum weights and volumes match package sizes currently available. Specifically, issues were raised regarding current package sizes of juice, jarred infant foods and whole grain bread (further discussed in Section F, Item 2). FNS recognizes that package sizes of WIC-eligible foods vary among manufacturers as well as regions. FNS also recognizes that manufacturers may change package sizes at any time. However, basing the maximum allowances in the interim rule on package sizes does not reduce the possibility of future changes in package sizes. This cost estimate does not incorporate any potential changes in package sizes but assumes that the maximum monthly allowance will be able to accommodate future changes to food packages sizes. 7. Uncertainties Summary Table 12 presents two additional cost estimates that reflect the potential aggregated effect of these alternative assumptions. The first assumes that all of the cost increasing alternate assumptions discussed above are realized. The second assumes that all of the cost decreasing alternate assumptions are realized. Scenario 1: a. Jarred infant foods will be prescribed at a 100% rate to eligible infants b. Whole grain bread and bread substitutes will be prescribed at a 100% rate c. 15% of women will be prescribed some soy beverage as a milk substitute d. Dairy prices will decrease by 10% Scenario 2: a. Jarred infant foods will be prescribed at a 90% rate to eligible infants b. Whole grain bread and bread substitutes will be prescribed at a 90% rate c. 5% of women will be prescribed some soy beverage as a milk substitute d. Dairy prices will increase by 10% The resulting combined range of uncertainty based on these assumptions is from a savings of $342 million to a cost of $359 million over five years, or −1.1% to +1.2% of total projected WIC program costs during that period, relative to the base assumptions. Table 12.—Projected Cost of WIC Food Package Revisions Under Alternate Extreme Assumptions FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Cost of Rule Under Scenario 1 $25.1 $78.4 $82.9 $75.4 $67.6 $329.3 Cost/Savings of Interim Rule 5.0 7.3 −2.5 −13.9 −25.6 −29.7 Difference Between Base Assumption and Scenario 1 −20.1 −71.0 −85.4 −89.3 −93.2 −359.1 Savings of Rule Under Scenario 2 −14.2 −60.3 −83.8 −98.8 −114.3 −371.4 Cost/Savings of Interim Rule 5.0 7.3 −2.5 −13.9 −25.6 −29.7 Difference Between Base Assumption and Scenario 2 19.2 67.6 81.3 84.9 88.7 341.6 F. Alternatives Based on comments received, FNS considered several alternatives to the Proposed Rule. Some of these alternatives are discussed below. Each of these alternatives was ultimately rejected because FNS believes that a food package which reflects the IOM recommendations as closely as possible within the constraint of cost neutrality best reflects current scientific consensus on how to meet the dietary needs of WIC participants. 1. Include Yogurt as a Milk Substitute for Food Packages IV-VII For Food Packages IV-VII, the IOM identified yogurt, tofu, and soy beverage as new milk substitutes to help ensure adequate calcium intake by those who cannot consume milk and to accommodate cultural preferences. Under the current rule cheese is also available as a milk substitute for up to three quarts of milk. IOM's recommendation specifically called for substituting one quart of yogurt or tofu for one quart of milk, and for limiting substitutions of cheese, yogurt, and tofu to four quarts of milk for Food Packages IV, V and VI, and six quarts of milk for Food Package VII. Soy beverage would be allowed for the entire milk allowance for Food Packages V, VI, and VII. In order to maintain cost-neutrality, the Proposed Rule eliminated yogurt as a milk substitute, but allows the substitution of tofu, cheese and soy beverages up to the IOM maximum substitution level. As shown in Table 13, the price of yogurt, $2.07 per quart, as compared to $.71 per quart for reduced-fat milk, considerably increases the monthly cost of Food Packages IV-VII. Soy beverage and tofu also have higher per unit costs than milk; however, the estimated amount of tofu purchased by WIC participants is substantially lower than that of yogurt, and soy beverage is priced lower than yogurt ($.70 less per quart) making it a more cost-efficient substitute. Table 13.—Projected Cost of Yogurt as a Milk Substitute Food package Estimated average prescribed amount (qt.) Price per unit (inflated to FY06) Cost per food package IV 0.86 $2.07 $1.78 V 0.84 2.07 1.74 VI 0.66 2.07 1.37 VII 0.83 2.07 1.72 The economic impact of including yogurt as a milk substitute is shown in Table 14. The five year cost of the rule, as modified by this alternative, is $384.0 million. The cost of the interim rule without yogurt is −$29.7 million (see Table 2). Therefore, the elimination of yogurt is retained in this interim rule. Table 14.—Projected Cost of WIC Food Package Revisions, Including Yogurt as a Milk Substitute [In $ millions] FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Total Cost of Rule with Alternate Assumption $28.2 $89.2 $95.9 $88.9 $81.8 $384.0 Total Cost of Interim Rule 5.0 7.3 −2.5 −13.9 −25.6 −29.7 Difference −23.2 −81.9 −98.4 −102.8 −107.4 −413.7 Negative values are cost reductions. Differences may not be exact due to rounding. 2. Increase the Whole Grain Maximum Allowance for Women to 24 Ounce Increments The Proposed Rule established a maximum of whole wheat bread or other whole grain—rice, barley (whole-grain), bulgur (cracked wheat), oatmeal and soft corn tortillas—monthly allowance of two pounds for children in Food Package IV and one pound for women in Food Packages V and VII. As recommended by the IOM, this is an enhancement to the current food packages which do not provide whole grains (except in breakfast cereals). Some comments on the Proposed Rule stated that most bread loaves are not sold in one or two pound packages and participants would have difficulty purchasing the maximum monthly allowance. In order to accommodate current bread package sizes the maximum allowance for whole grains would need to be increased to 48 ounces for children and 24 ounces for women. Not only would changing the whole grain maximum allowance to accommodate package sizes currently available in the market significantly increase the overall cost of the interim rule (as shown in Table 15), it is not administratively practical for FNS to change maximum allowances based on current manufacturer packaging as they may vary by region and may change in future years. Therefore, whole grain maximum allowances set in the Proposed Rule are retained in this interim rule. Table 15.—Projected Cost (+) / Savings (-) Associated With Increasing the Whole Grain Maximum Allowance for Women and Children [In $ millions] FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Total Cost of Rule with Alternative $25.2 $78.7 $83.3 $75.8 $68.0 $331.1 Total Cost of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference -$20.2 -$71.4 -$85.8 -$89.7 -$93.7 -$360.8 Negative values are cost reductions. Differences may not be exact due to rounding. 3. Fresh Fruits and Vegetables for Infants The Proposed Rule added jarred infant fruits and vegetables to Food Package II and jarred infant meats to Food Package II for fully breast fed infants. Food Package II also provides a maximum allowance of two pounds of fresh bananas. Comments on the Proposed Rule asked that fresh, canned or frozen fruits and vegetables be allowed in Food Package II instead of or as an option to jarred infant fruits and vegetables. The estimate shown below assumes that cash value vouchers replace the interim rule's current infant fruit and vegetable provision. The initial value of the vouchers are set to the nearest whole dollar equivalent of the interim rule's recommended quantity of infant fruits and vegetables. It is assumed that the vouchers are redeemed and inflated in the same manner as the fruit and vegetable vouchers for women and children. In place of the interim rule's current provision, a fruit and vegetable voucher for infants would reduce the overall cost of the rule by $133.2 million over five years. 59 59 The savings is a consequence of two factors. The first is the assumption that fruit and vegetable vouchers for infants will be issued at their full values, but redeemed at a rate of just 87.5% (the same assumption that applies to fruit and vegetable vouchers for women and children in the baseline estimate.) The jarred fruit and vegetable benefit, by contrast, is assumed to be prescribed at an average rate equal to 94.3% of the package maximum (95.8% after rounding up to an even number of jars) and redeemed by beneficiaries at 100%. The second factor which makes the voucher option relatively less expensive is the voucher inflation and rounding rule which limits future increases to whole dollar increments. The effects of inflation are accrued annually, but not realized until the cumulative increase in the CPI is sufficient to raise the voucher's value by a dollar. See interim rule section 246.16(j). Table 16.—Projected Cost (+) / Savings (-) Associated With Issuing Fresh Fruit and Vegetable Vouchers to Infants 6-11.9 Months of Age [In $ millions] FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 Total Total Cost of Rule with Alternative $1.0 -$11.0 -$27.6 -$44.6 -$50.9 -$133.2 Total Cost of Interim Rule 5.0 7.3 -2.5 -13.9 -25.6 -29.7 Difference 4.0 18.3 25.0 30.8 25.3 103.5 Negative values are cost reductions. Differences may not be exact due to rounding. The IOM recommended that commercial baby food fruits and vegetables and fresh bananas replace juice in the current package. The IOM encourages the continuation of full breastfeeding past 6 months, and recommended that higher amounts of baby food fruits and vegetables and baby food meats be provided to fully breastfeeding infants. Commercial baby foods were recommended due to nutrient content, availability in developmentally appropriate textures, and food safety. 60 In addition, the provision of commercial baby food fruits and vegetables helps ensure that these items are consumed by infants and not other household members. FNS believes that nutrition education provided by WIC staff related to appropriate food choices and home preparation of foods for infants is compatible with provision of jarred infant foods. Therefore, this alternative was rejected. 60 IOM, p. 103. 4. Soy Beverage Substitution for Children Without Medical Documentation The Proposed Rule allowed State agencies to authorize, with medical documentation, soy-based beverages and tofu substitutions for milk for children in Food Package IV. Some comments received on the Proposed Rule expressed opposition to the medical documentation requirement citing that it creates barriers for children to obtain foods that meet cultural needs. Requiring medical documentation for dairy alternatives ensures that a health care provider is aware that children may be at nutritional risk when milk is replaced by other foods. The IOM recommended that soy beverage not be made available to children to satisfy participant preference in the absence of medical need. Research suggests that up to 4% of children consume some sort of soy beverage and that percentage increases as they get older. 61 FNS does not collect data on the percentage of WIC children who request milk alternatives, and the percentage of children that would request soy beverage in place of milk is difficult to estimate. However, given the price differential between reduced fat milk ($.71 per quart) and soy beverage ($1.37 per quart), and the number of WIC-eligible children, substitution of soy beverage for milk without medical documentation could result in a significant increase to the overall cost of the rule. 61 United Soybean Board, Current Knowledge on Soy and Children's Diets, August 2004, prepared by N. Chapman and Associates. *http://www.soyfoods.org/wp-content/uploads/2006/11/soy_and_child_diet.pdf.* On both economic grounds and on the expert recommendation of the IOM, FNS retains the medical documentation requirement for soy beverage in the children's food package. G. Market Share Analysis The changes in the quantities and types of foods provided by the WIC program should result in changes in the quantities and types of foods that WIC participants buy with their WIC vouchers. The complete market impact of this rule is difficult to accurately quantify because we do not know the extent to which WIC foods substitute for purchases WIC participants would have otherwise made with their own funds. Empirical research on this issue is inconclusive. 62 Because of this uncertainty, we present two scenarios. In the first (Table 17), we assume full substitution—that is, all foods purchased with WIC vouchers under the current packages would otherwise be purchased with the participants' own funds under the interim rule. In the second (Table 18), we assume the alternate—that none of the foods purchased with WIC vouchers would otherwise be purchased with the participants' own funds. In both scenarios, the potential impact of the interim rule on the total market size for most foods is relatively modest, as is the impact on WIC's share of the total market. 62 Mary Kay Fox, William Hamilton, Biing-Hwan Lin, *Effects of Food Assistance and Nutrition Programs on Nutrition and Health, Volume 3, Literature Review, Economic Research Service,* U.S. Department of Agriculture, Food Assistance and Nutrition Research Report Number 19-3. October 2004. We estimated the total value of WIC sales 63 for each food item and the total annual U.S. retail sales for each WIC food item. To estimate WIC sales, we multiplied the average unit price per food item by an estimate of the quantity of food purchased by WIC participants (the average estimated participation multiplied by the amount of food prescribed to a participant throughout the course of a year). 64 To estimate total annual sales, 2005 AC Nielsen Productscan data was used to calculate total volume and annual grocery store sales of the different categories of food products. 65 We used calendar year

(CY)2005 participation, cost and sales estimates for our market share analysis. Although the rule does not take effect until FY2008, we cannot reliably make projections about the overall sales of WIC food items for the next two years; we believe the CY2005 data provides a good indication of the relative impact of the rule's changes on each food item. 63 WIC sales refer only to sales produced by the use of WIC vouchers, not the total sales from all purchases made by WIC participants. 64 Prescription amounts used in this market share analysis are the same as those used in the cost analysis. 65 Total annual sales include foods that fit in the category of food product, but may not be WIC eligible (i.e., within cereal, total sales include cereals of any sugar content and cereals without whole grains). This was done to accurately portray the impact of the proposed food package on the whole market and not just the narrow sub-market of “WIC eligible” food. Because AC Nielsen Productscan data covers approximately 70% of the total grocery market, total annual sales were adjusted by dividing by 70%. It is important to note that this approach understates the size of the total markets for WIC food items (and thus overstates both WIC's market share and the potential impact of the changes on WIC food markets), because the data used to estimate total market size is limited to grocery store sales. Data on sales through other outlets was not available, but would likely significantly increase the estimated size of the total market for WIC foods. Table 17.—Estimated Total Annual Sales, WIC Sales, and WIC Percent of Market for Current Food Package and Interim Food Package, Assuming Full Substitution of WIC Foods in Total Annual Sales, CY2005 WIC food item Current food package Estimated total annual sales ($) Estimated total WIC sales ($) 66 WIC % of market 67 Interim food package Estimated total annual sales ($) Estimated total WIC sales ($) WIC % of market 67 Formula 3,600,257,587 2,533,590,541 70.4 3,600,257,587 2,025,525,861 56.3 Beans 874,176,643 32,179,354 3.7 874,176,643 82,632,904 9.5 Peanut butter 1,133,273,041 40,935,940 3.6 1,133,273,041 54,492,515 4.8 Milk 16,043,036,006 975,287,323 6.1 16,043,036,006 712,840,678 4.4 Adult cereal 9,697,058,781 399,336,655 4.1 9,697,058,781 399,336,655 4.1 Juice 14,203,760,671 556,756,383 3.9 14,203,760,671 281,143,313 2.0 Rice 737,198,377 0 737,198,377 43,442,898 5.9 Fruit and vegetables 15,761,934,300 7,512,820 0.0 15,761,934,300 431,691,818 2.7 Eggs 2,959,401,900 120,241,255 4.1 2,959,401,900 67,192,054 2.3 Cheese 12,329,016,799 386,210,204 3.1 12,329,016,799 247,273,210 2.0 Bread 17,028,860,749 0 17,028,860,749 93,740,564 0.6 Canned fish 1,917,928,393 9,191,549 0.5 1,917,928,393 10,885,456 0.6 Infant cereal 68 56,640,143 42,641,463 Baby food 68 0 185,899,515 Tofu 68 0 1,088,288 Soy beverage 68 0 49,561,168 Total 96,285,903,247 5,117,882,167 6.4 96,285,903,247 4,729,388,359 4.6 66 Total WIC sales reported here are less than the $5.3 billion (pre-rebate) reported in WIC 2005 food costs. The estimates of total WIC food sales for the current and proposed packages are likely to be lower than actual WIC food expenditures because the AC Nielsen Productscan and Homescan data used to estimate food prices may not fully capture the higher prices charged by WIC vendors such as small, non-chain, convenience and “WIC-Only” stores. 67 “WIC % of Market” estimates are calculated only for items for which we have both a numerator and denominator. 68 We were unable to assess the market impact of infant cereal, baby food, tofu and soy beverage items in the WIC food package. These items are not included in the Productscan data; however, we are able to estimate WIC sales because these items are part of the Homescan data, which is our source for item price data. Table 18.—Estimated Total Annual Sales, WIC Sales, and WIC Percent of Market for Current Food Package and Interim Food Package, Assuming No Substitution of WIC Foods in Total Annual Sales, CY2005 WIC food item Current Food Package Estimated total annual sales ($) Estimated total WIC sales ($) 69 WIC % of market 70 Interim food package Estimated total annual sales ($) Estimated total WIC sales ($) WIC % of market 70 Formula 3,600,257,587 2,533,590,541 70.4 3,092,192,907 2,025,525,861 65.5 Beans 874,176,643 32,179,354 3.7 924,630,192 82,632,904 8.9 Peanut butter 1,133,273,041 40,935,940 3.6 1,146,829,616 54,492,515 4.8 Milk 16,043,036,006 975,287,323 6.1 15,780,589,361 712,840,678 4.5 Adult cereal 9,697,058,781 399,336,655 4.1 9,697,058,781 399,336,655 4.1 Juice 14,203,760,671 556,756,383 3.9 13,928,147,601 281,143,313 2.0 Rice 737,198,377 0 780,641,275 43,442,898 5.6 Fruit and vegetables 15,761,934,300 7,512,820 0.0 16,186,113,298 431,691,818 2.7 Eggs 2,959,401,900 120,241,255 4.1 2,906,352,699 67,192,054 2.3 Cheese 12,329,016,799 386,210,204 3.1 12,190,079,804 247,273,210 2.0 Bread 17,028,860,749 0 17,122,601,313 93,740,564 0.5 Canned fish 1,917,928,393 9,191,549 0.5 1,919,622,300 10,885,456 0.6 Infant cereal 71 56,640,143 42,641,463 Baby food 71 0 185,899,515 Tofu 71 0 1,088,288 Soy beverage) 71 0 49,561,168 Total 96,285,903,247 5,117,882,167 6.4 95,674,859,149 4,729,388,359 4.7 69 Total WIC sales reported here are less than the $5.3 billion dollars (pre-rebate) reported in WIC 2005 food costs. The estimates of total WIC food sales for the current and proposed packages are likely to be lower than actual WIC food expenditures because the AC Nielsen Productscan and Homescan data used to estimate food prices may not fully capture the higher prices charged by WIC vendors such as small, non-chain, convenience and “WIC-Only” stores. 70 “WIC% of Market” estimates are calculated only for items for which we have both a numerator and denominator. 71 We were unable to assess the market impact of infant cereal, baby food, tofu and soy beverage items in the WIC food package. These items are not included in the Productscan data; however, we are able to estimate WIC sales because these items are part of the Homescan data, which is our source for item price data. It is important to note that the numbers in Tables 17 and 18 differ from the costs reported in Table 3 mainly because the market analysis uses pre-rebate formula and cereal costs as compared to the cost estimate which factors in the post-rebate savings. In addition, the data in the market impact analysis is based on 2005 participation, whereas the cost estimate uses the projected participation estimates for 2008 and beyond. Finally, the market analysis does not take into account any phase-in period. Overall, the changes in the WIC food package will have a modest impact on WIC sales as a percentage of total annual sales of these food item categories. Market shares are slightly higher under the no substitution scenario. (See Table 17.) For the foods that are currently part of the food package, the interim food package has the largest dollar impact on the infant formula and beans markets. Under the interim food package, the market share of WIC sales for infant formula is less than with the current food package. The decline is mostly due to a reduction in the maximum allowance of infant formula for partially breastfed and fully formula-fed infants 6 through 11 months of age (Food Package II FF). The market share of beans will increase from 3.7% to 8.9%-9.5%. The majority of this impact stems from the fact that participants can now substitute canned beans, which are more expensive, for dried beans. The other markets that will be impacted and are currently part of the food package are the milk, juice, eggs, cheese, peanut butter, and fruit and vegetable markets. The market share of these items will change slightly. The items that will have decreases are milk, juice, eggs, and cheese, while the items that will have increases are peanut butter, and fruits and vegetables. The WIC market share of milk will change from 6.1% to 4.4%-4.5% due to lower prescription amounts and the ability of participants to substitute tofu, and soy beverage for fluid milk. The decline in cheese is also due to these reasons. The share of the juice market shifts from 3.9% to 2.0%, while the share of the egg market shifts from 4.1% to 2.3%. Both of these declines stem from changes in the package that are designed to improve the overall nutritional benefit of the package. Participants will be receiving less juice, but more fruits and vegetables. The amount of eggs will be lowered consistent with recommendations of the IOM on cholesterol intake and to permit a wider variety of foods to be included in the WIC food packages. The market share of peanut butter will increase from 3.6% to 4.8%. Lastly, the WIC percent of the fruit and vegetable market will increase from 0% to 2.7%. This is due to the fact that the only fruit or vegetable that WIC participants currently receive are carrots and only exclusively breastfeeding mothers receive them. Under the new rule, the fruit and vegetable vouchers will encourage WIC's women and children participants to consume these foods. For the foods being added to the WIC food package, the WIC market share percentages are, for the most part, small, 0.5%-0.6% and 5.6%-5.9%, for bread and rice, respectively. We were unable to assess the market impact of baby food, infant cereal, tofu and soy beverage. These items are not included in the Productscan data; however, we are able to estimate WIC sales because these items are part of the Homescan data, which is our source for item price data. Given the changes in market share and potential changes in total market demand, changes in the purchases of WIC-provided foods could theoretically have an impact on prices for WIC foods. However, because the demand impacts for most foods are small and impossible to estimate precisely, we are unable to determine the potential price effects. WIC purchases of infant formula represent a larger share of the total market of WIC-provided foods than do WIC purchases of the other WIC foods. The Economic Research Service

(ERS)recently studied the relationship between retail prices of infant formula and demand for WIC-provided formula. ERS findings suggest that the amount of WIC-provided formula purchased has an effect on retail prices; specifically, larger WIC demand leads to higher retail prices for non-WIC consumers who purchase the state's contract brand of formula. 72 ERS estimates, for example, that a non-WIC family in a State whose WIC program serves two-thirds of all formula fed infants would spend roughly $3 to $5 more, per month, on contract brand powder formula for their child than a family in a State whose WIC program serves just half of formula-fed infants. However, it is difficult to project the exact impact of the reduction in WIC demand for infant formula under the interim rule based on this study. The ERS analysis was limited to formulas sold in supermarkets, whereas projecting the impact of the rule on overall demand would require an analysis of the behavior of non-WIC consumers, which have more diverse purchasing habits. For instance, many non-WIC formula purchases are at prices below that of supermarkets from mass merchandisers that do not participate in the WIC Program. In addition, the change in WIC formula sales as a percentage of retail grocery sales due to this interim rule (from 70.4% to 56.3%-65.5%) is smaller than the changes in WIC sales examined in the ERS report (from 50% to 66%). 72 Victor Oliveira, Mark Prell, David Smallwood, Elizabeth Frazão, *WIC and the Retail Price of Infant Formula,* Economic Research Service, U.S. Department of Agriculture, May 2004, p. 60. Appendix A: Additional Cost Estimate Assumptions Table A1.—FY 08 Food Package Costs [Monthly costs, post-rebate] Food package Current Interim I—0 to 5.9 month infants 73 $24.49 $20.84 II—6 to 11.9 month infants 33.32 41.06 III—Participants with qualifying conditions 74 0.00 21.07 IV—Children 1 to 4.9 years 35.18 34.49 V—Women: Pregnant and partially breastfeeding 39.82 42.66 VI—Women: Postpartum 32.15 33.38 VII—Women: Fully breastfeeding 51.23 54.56 73 To permit a direct comparison against the current rule, average food package costs under the current rule are weighted by the number of children who fall into the age categories that correspond to the interim rule food packages. Although the current cost figures for infants do not correspond to the food package definitions under the interim rule, the average costs of foods prescribed to infants within the stated age categories are correct. That is, the cost of monthly food prescriptions to infants up to 5 months old is lower under the interim rule by approximately $3.60. [Current Food Package I is for infants 0-3.9 months of age; interim Food Package I is for infants 0-5.9 months of age. Current Food Package II is for infants 4-11.9 months of age; interim Food Package II is for infants 6-11.9 months of age. Food package costs are weighted by the respective age groups as shown in Tables D and E in Appendix A.] Table A2.—Annual Current Food Package Costs (Post-Rebate) FY08-FY12 [In $ millions] Food package FY08 75 FY09 FY10 FY11 FY12 I $272.18 $342.02 $357.69 $373.79 $390.35 II 331.53 416.59 435.68 455.29 475.46 III 74 0.00 0.00 0.00 0.00 0.00 IV 1,454.11 1,827.21 1,910.94 1,996.95 2,085.41 V 456.17 573.22 599.49 626.47 654.22 VI 206.42 259.39 271.27 283.48 296.04 VII 169.47 212.95 222.71 232.74 243.05 74 Current Food Package III is $0 because the analysis only considers the incremental costs associated with the proposal. Interim Food Package III represents the incremental costs as a result of the changes in the proposed rule. FNS does not have comprehensive data on the current cost of medical foods provided in Food Package III. However, the medical foods associated with this package are assumed to stay the same under the current and interim rules. The incremental cost is extending foods from other packages to Food Package III recipients. Table A3.—Annual Interim Food Package Costs (Post-Rebate) FY08-FY12 [In $ millions] Food package FY08 75 FY09 FY10 FY11 FY12 I $259.58 $297.59 $304.29 $317.98 $332.07 II 355.40 500.78 536.88 561.05 585.90 III 74 3.02 10.64 12.79 13.36 13.95 IV 1,435.66 1,756.20 1,818.93 1,894.24 1,971.64 V 462.71 594.06 622.09 647.66 673.95 VI 206.88 259.75 270.33 281.14 292.25 VII 171.61 219.70 229.93 239.41 249.14 75 For both the current and interim rules, FY 08 figures represent just 10 months (the interim rule will be effective for just 10 months of the year.) The interim rule figures are not fully phased-in until FY 2010. Table B.—CY05 to FY06 Price Inflation Assumptions—Food Specific CPIs Food item Inflation rate (percent) Infant Formula 1.3 Infant cereal −1.7 Infant food fruit and vegetables 2.5 Infant food meat 2.5 Bananas 4.2 Milk: Whole −0.7 Reduced fat −0.5 Cheese −0.9 Yogurt −0.3 Tofu 1.3 Soy beverage 1.3 Juice 3.9 Adult cereal: Whole grain −1.7 Current WIC cereals −1.7 Eggs 2.9 Beans: Dry 1.0 Canned 1.0 Peanut butter 0.9 Whole grain bread 3.2 Brown rice 3.7 Tuna 2.5 Canned Fish 2.5 Carrots 3.4 Table C.—Inflation Assumptions, FY05-FY12 Year Thrifty food plan (% change) CPI: fruit and vegetables (% change) FY05 * −0.32 3.74 FY06 * −0.75 4.76 FY07 * 2.05 1.03 FY08 2.62 1.96 FY09 2.58 1.88 FY10 2.45 1.92 FY11 2.37 1.92 FY12 2.30 1.92 *Actual WIC Food Package Inflation as of January 2007. Table D.—Projected Participation in the WIC Program, by Food Package Type: Current Packages Food package FY08 FY09 FY10 FY11 FY12 I 0-3.9 month Infants: Fully formula-fed 426,994 435,882 444,956 454,218 463,674 Partially breast-fed 112,821 115,169 117,567 120,014 122,513 Fully breast-fed 199,996 204,159 208,409 212,747 217,176 Subtotal 739,810 755,211 770,932 786,980 803,362 II 4-5.9 month Infants: Fully formula-fed 283,539 289,441 295,466 301,617 307,895 Partially breast-fed 31,566 32,223 32,894 33,579 34,278 Fully breast-fed 56,262 57,433 58,628 59,849 61,095 6-11.9 month Infants: Fully formula-fed 840,456 857,952 875,811 894,043 912,654 Partially breast-fed 56,380 57,554 58,752 59,975 61,224 Fully breast-fed 98,114 100,156 102,241 104,369 106,542 Subtotal 1,366,316 1,394,759 1,423,793 1,453,432 1,483,687 III Participants with qualifying conditions 76 92,470 94,395 96,360 98,366 100,414 IV Children: 1-4.9 years 4,133,746 4,219,798 4,307,640 4,397,311 4,488,849 V Women: Pregnant 958,254 978,202 998,564 1,019,351 1,040,571 Partially breastfeeding 187,421 191,323 195,305 199,371 203,521 Subtotal 1,145,675 1,169,524 1,193,870 1,218,722 1,244,092 VI Women: Postpartum 642,045 655,410 669,054 682,981 697,198 VII Women: Fully breastfeeding 330,813 337,700 344,730 351,906 359,231 Total 8,450,876 8,626,796 8,806,378 8,989,698 9,176,834 76 The interim rule moves infants with qualifying medical conditions from Food Packages I and II to a revised Food Package III. The number of Package III beneficiaries shown here includes those who are reassigned to Package III as a result of the interim rule. Individuals who are currently Package III recipients, and those who are newly moved to Package III by the interim rule, are affected differently by the interim rule than are other participants. The current and newly assigned Package III recipients are also handled differently than other participants throughout this cost analysis. For purposes of clarity and consistency, all of these individuals are shown as Package III recipients from the first through the final steps of the analysis. Table E.—Projected Participation in the WIC Program, by Food Package Type: Interim Rule Food package FY08 FY09 FY10 FY11 FY12 I 0-3.9 month Infants: Fully formula-fed 426,994 435,882 444,956 454,218 463,674 Partially breast-fed 112,821 115,169 117,567 120,014 122,513 Fully breast-fed 199,996 204,159 208,409 212,747 217,176 4-5.9 month Infants: Fully formula-fed 283,539 289,441 295,466 301,617 307,895 Partially breast-fed 31,566 32,223 32,894 33,579 34,278 Fully breast-fed 56,262 57,433 58,628 59,849 61,095 Subtotal 1,111,176 1,134,307 1,157,920 1,182,024 1,206,630 II 6-11.9 month Infants: Fully formula-fed 840,456 857,952 875,811 894,043 912,654 Partially breast-fed 56,380 57,554 58,752 59,975 61,224 Fully breast-fed 98,114 100,156 102,241 104,369 106,542 Subtotal 994,950 1,015,662 1,036,805 1,058,387 1,080,420 * III Participants with qualifying conditions 76 92,470 94,395 96,360 98,366 100,414 IV Children: 1-1.9 years 1,364,955 1,393,369 1,422,374 1,451,984 1,482,209 2-4.9 years 2,768,791 2,826,428 2,885,265 2,945,327 3,006,639 Subtotal 4,133,746 4,219,798 4,307,640 4,397,311 4,488,849 V Women: Pregnant 958,254 978,202 998,564 1,019,351 1,040,571 Partially breastfeeding 187,421 191,323 195,305 199,371 203,521 Subtotal 1,145,675 1,169,524 1,193,870 1,218,722 1,244,092 VI Women: Postpartum 642,045 655,410 669,054 682,981 697,198 VII Women: Fully breastfeeding 330,813 337,700 344,730 351,906 359,231 Total 8,450,876 8,626,796 8,806,378 8,989,698 9,176,834 [FR Doc. E7-23033 Filed 12-5-07; 8:45 am] BILLING CODE 3410-30-P 72 234 Thursday, December 6, 2007 Proposed Rules Part III Department of the Interior Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; Review of Native Species That Are Candidates for Listing as Endangered or Threatened; Annual Notice of Findings on Resubmitted Petitions; Annual Description of Progress on Listing Actions; Proposed Rule DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; Review of Native Species That Are Candidates for Listing as Endangered or Threatened; Annual Notice of Findings on Resubmitted Petitions; Annual Description of Progress on Listing Actions AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of review. SUMMARY: In this Candidate Notice of Review (CNOR), we, the U.S. Fish and Wildlife Service (Service), present an updated list of plant and animal species native to the United States that we regard as candidates for or have proposed for addition to the Lists of Endangered and Threatened Wildlife and Plants under the Endangered Species Act of 1973, as amended. Identification of candidate species can assist environmental planning efforts by providing advance notice of potential listings, allowing landowners and resource managers to alleviate threats and thereby possibly remove the need to list species as endangered or threatened. Even if we subsequently list a candidate species, the early notice provided here could result in more options for species management and recovery by prompting candidate conservation measures to alleviate threats to the species. The CNOR summarizes the status and threats that we evaluated in order to determine that species qualify as candidates and to assign a listing priority number

(LPN)to each species, or to remove species from candidate status. Additional material that we relied on is available in the Species Assessment and Listing Priority Assignment Forms (species assessment forms, previously called candidate forms) for each candidate species. Overall, this CNOR recognizes 5 new candidates, changes the LPN for 29 candidates, and removes 4 species from candidate status. Combined with other decisions for individual species that were published separately from this CNOR, the new number of species that are candidates for listing is 280. We request additional status information that may be available for the 280 candidate species identified in this CNOR. We will consider this information in preparing listing documents and future revisions to the notice of review, as it will help us in monitoring changes in the status of candidate species and in management for conserving them. We also request information on additional species that we should consider including as candidates as we prepare future updates of this notice. This document also includes our findings on resubmitted petitions and describes our progress in revising the Lists of Endangered and Threatened Wildlife and Plants during the period September 26, 2006, through September 30, 2007. DATES: We will accept comments on the most recent Candidate Notice of Review at any time. ADDRESSES: Submit your comments regarding a particular species to the Regional Director of the Region identified in SUPPLEMENTARY INFORMATION as having the lead responsibility for that species. You may mail or fax comments of a more general nature to the Chief, Division of Conservation and Classification, U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Room 420, Arlington, VA 22203 (facsimile 703/358-2171). Written comments and materials we receive in response to this notice will be available for public inspection by appointment at the Division of Conservation and Classification (for comments of a general nature only) or at the appropriate Regional Office listed in SUPPLEMENTARY INFORMATION . Species assessment forms with information and references on a particular candidate species' range, status, habitat needs, and listing priority assignment are available for review at the appropriate Regional Office listed below in SUPPLEMENTARY INFORMATION or at the Division of Conservation and Classification, Arlington, Virginia (see address above), or on our Internet Web site ( *http://endangered.fws.gov/candidates/index.html* ). FOR FURTHER INFORMATION CONTACT: The Endangered Species Coordinator(s) in the appropriate Regional Office(s) or Chris Nolin, Chief, Division of Conservation and Classification (telephone 703-358-2171; facsimile 703-358-1735). Persons who use a telecommunications device for the deaf

(TDD)may call the Federal Information Relay Service

(FIRS)at 800-877-8339. SUPPLEMENTARY INFORMATION: Candidate Notice of Review Background The Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ) (Act), requires that we identify species of wildlife and plants that are endangered or threatened, based on the best available scientific and commercial information. As defined in section 3 of the Act, an endangered species is any species which is in danger of extinction throughout all or a significant portion of its range, and a threatened species is any species which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. Through the Federal rulemaking process, we add species that meet these definitions to the List of Endangered and Threatened Wildlife at 50 CFR 17.11 or the List of Endangered and Threatened Plants at 50 CFR 17.12. As part of this program, we maintain a list of species that we regard as candidates for listing. A candidate species is one for which we have on file sufficient information on biological vulnerability and threats to support a proposal to list as endangered or threatened, but for which preparation and publication of a proposal is precluded by higher-priority listing actions. We maintain this list of candidates for a variety of reasons: to notify the public that these species are facing threats to their survival; to provide advance knowledge of potential listings that could affect decisions of environmental planners and developers; to provide information that may stimulate and guide conservation efforts that will remove or reduce threats to these species and possibly make listing unnecessary; to solicit input from interested parties to help us identify those candidate species that may not require protection under the Act or additional species that may require the Act's protections; and to solicit necessary information for setting priorities for preparing listing proposals. We strongly encourage collaborative conservation efforts for candidate species and offer technical and financial assistance to facilitate such efforts. For additional information regarding such assistance, please contact the appropriate Regional Office listed in SUPPLEMENTARY INFORMATION or visit our Internet Web site, *http://endangered.fws.gov/candidates/index.html* . Previous Notices of Review We have been publishing candidate notices of review

(CNOR)since 1975. The most recent CNOR (prior to this CNOR) was published on September 12, 2006 (71 FR 53755). CNORs published since 1994 are available on our Internet Web site, *http://www.fws.gov/endangered/candidates/index.html* . For copies of CNORs published prior to 1994, please contact the Division of Conservation and Classification (see ADDRESSES section above). On September 21, 1983, we published guidance for assigning an LPN for each candidate species (48 FR 43098). Using this guidance, we assign each candidate an LPN of 1 to 12, depending on the magnitude of threats, imminence of threats, and taxonomic status; the lower the LPN, the higher the listing priority (that is, a species with an LPN of 1 would have the highest listing priority). Such a priority ranking guidance system is required under section 4(h)(3) of the Act (15 U.S.C. 1533(h)(3)). As explained below, in using this system we first categorize based on the magnitude of the threat(s), then by the immediacy of the threat(s), and finally by taxonomic status. Under this priority ranking guidance system, magnitude of threat can be either “high” or “moderate to low.” This criterion helps ensure that the species facing the greatest threats to their continued existence receive the highest listing priority. It is important to recognize that all candidate species face threats to their continued existence, so the magnitude of threats is in relative terms. When evaluating the magnitude of the threat(s) facing the species, we consider information such as: the number of populations and/or extent of range of the species affected by the threat(s); the biological significance of the affected population(s), taking into consideration the life history characteristics of the species and its current abundance and distribution; whether the threats affect the species in only a portion of its range, and if so the likelihood of persistence of the species in the unaffected portions; and whether the effects are likely to be permanent. As used in our priority ranking system, immediacy of threat is categorized as either “imminent” or “nonimminent” and is not a measure of how quickly the species is likely to become extinct if the threats are not addressed; rather, immediacy is based on when the threats will begin. If a threat is currently occurring or likely to occur in the very near future, we classify the threat as imminent. Determining the immediacy of threats helps ensure that species facing actual, identifiable threats are given priority for listing proposals over those for which threats are only potential or species intrinsically vulnerable to certain types of threats but not known to be presently facing such threats. Our priority ranking system has three categories for taxonomic status: Species that are the sole members of a genus; full species (in a genus that has more than one species); and subspecies, distinct population segments of vertebrate species, and species for which listing is appropriate in a significant portion of their range. The result of the ranking system is that we assign each candidate a listing priority number of 1 to 12. For example, if the threat(s) is of high magnitude, with immediacy classified as imminent, the listable entity is assigned an LPN of 1, 2, or 3 based on its taxonomic status (e.g., if the species is the only member of a genus, it would be assigned to the LPN 1 category, a full species to LPN 2, and a subspecies, DPS, or significant portion of the range to LPN 3). In summary, the LPN ranking system provides a basis for making decisions about the relative priority for preparing a proposed rule to list a given species. No matter which LPN we assign to a species, each species included in this notice as a candidate is one for which we have sufficient information to prepare a proposed rule to list it because it is in danger of extinction or likely to become endangered within the foreseeable future throughout all or a significant portion of its range. For more information on the process and standards used in assigning LPNs, a copy of the guidance is available on our Web site at: *http://www.fws.gov/endangered/policy/index.html* . For more information on the LPN assigned to a particular species, the species assessment for each candidate contains the LPN chart and a detailed explanation of the rationale for the determination of the magnitude and imminence of threat(s) and assignment of the LPN; that information is summarized in this CNOR. This revised notice supersedes all previous animal, plant, and combined candidate notices of review. Summary of This CNOR Since publication of the CNOR on September 12, 2006 (71 FR 53756), we reviewed the available information on candidate species to ensure that a proposed listing is justified for each species, and reevaluated the relative LPN assigned to each species. We also evaluated the need to emergency-list any of these species, particularly species with high priorities (i.e., species with LPNs of 1, 2, or 3). This review and reevaluation ensures that we focus conservation efforts on those species at greatest risk first. (In addition to reviewing candidate species, we have worked on numerous findings in response to petitions to list species, and on proposed and final determinations for rules to list species under the Act; some of these findings and determinations have been completed and published in the **Federal Register** , while work on others is still under way. See the discussions of Preclusion and Expeditious Progress, below, for details.) Based on our review of the best available scientific and commercial information, with this CNOR we identify 5 new candidate species (see *New Candidates* , below), change the LPN for 28 candidates (see Listing Priority Changes in Candidates, below) and determine that listing proposals are not warranted for 4 species and thus remove them from candidate status (see *Candidate Removals* , below). Combined with the other decisions published separately from this CNOR for individual species that previously were candidates, a total of 280 species (including 139 plant and 141 animal species) are now candidates awaiting preparation of rules proposing their listing. These 280 species, along with the 2 species currently proposed for listing, are included in Table 1. (Note, regarding the two species currently proposed for listing, we proposed one since the last CNOR and we proposed the other prior to the last CNOR.) Table 2 includes 8 species identified in the previous CNOR as either proposed for listing or classified as candidates that are no longer in those categories. This includes four species for which we published separate findings that listing is not warranted, plus the four species that we have determined do not warrant preparation of a rule to propose listing and therefore have removed from candidate status in this CNOR. New Candidates Below we present brief summaries of five new candidates that we are recognizing in this CNOR, including one species of mammal, one amphibian, one fish, one snail, and one plant. Complete information, including references, can be found in the species assessment forms. You may obtain a copy of these forms from the Regional Office having the lead for the species, or from our Internet Web site ( *http://endangered.fws.gov/candidates/index.html* ). For each of these five species, we find that we have on file sufficient information on biological vulnerability and threats to support a proposal to list as endangered or threatened, but that preparation and publication of a proposal is precluded by higher-priority listing actions (i.e., these meet our definition of a candidate species). We also note below that one other species, Casey's June beetle (an insect), was identified as a candidate earlier this year in a separate finding published in the **Federal Register** . Mammals New Mexico meadow jumping mouse ( *Zapus hudsonius luteus* )—The following summary is based on information contained in our files. The New Mexico meadow jumping mouse (jumping mouse) is endemic to New Mexico, Arizona, and a small area of southern Colorado. The jumping mouse nests in dry soils but uses moist, streamside, dense riparian/wetland vegetation. Recent genetic studies confirm that the New Mexico meadow jumping mouse is a distinct subspecies from other *Zapus hudsonius* subspecies, confirming the currently accepted subspecies designation. The threats that have been identified are excessive grazing pressure, water use and management, highway reconstruction, development, and recreation. Surveys conducted in 2005 and 2006 documented a drastic decline in the number of occupied localities and suitable habitat across the range of the species in New Mexico and Arizona. Of the original 98 known historical localities, there are now only 10 known extant localities in New Mexico, 1 in Arizona, and an additional 8 localities that have not been surveyed since the early to mid 1990s. Moreover, the highly fragmented nature of its distribution is also a major contributor to the vulnerability of this species and increases the likelihood of very small, isolated populations being extirpated. The paucity of secure populations, and the destruction, modification, or curtailment of its habitat, poses the most immediate threats to this species. Because the threats affect the jumping mouse in all but two of the extant localities, the threats are of a high magnitude. These threats are currently occurring and, therefore, are imminent. Thus, we assigned an LPN of 3 to this subspecies. Amphibians Arizona treefrog, Huachuca/Canelo Distinct Population Segment

(DPS)( *Hyla wrightorum* )—The following summary is based on information in our files. The population is known from three general localities at Rancho Los Fresnos, northern Sonora, Mexico, and 13-15 verified localities and one unverified locality in the Huachuca Mountains and Canelo Hills of Arizona. The population is both discrete and significant in accordance with our February 7, 1996, DPS policy (61 FR 4721). Evidence exists that the DPS persists in an ecological setting that is unique for the taxon, that loss of the population segment would result in a significant gap in the range of the taxon, and that the population segment differs markedly from other populations of the species in its genetic characteristics. The population is discrete from the Mogollon Rim population of Arizona and New Mexico based on a physical separation of 130 miles, and from the Sierra Madre Occidental population in Sonora and Chihuahua, Mexico by 145 miles. The most significant threats to the existence of the Huachuca/Canelo population of the Arizona treefrog are, in order of importance, habitat loss or degradation and direct mortality due to catastrophic fire; loss of populations due to drought or floods, which may be exacerbated by climatic extremes; predation by introduced species; and habitat degradation caused by livestock grazing, off-highway vehicles, and environmental contamination. The effects of these threats are exacerbated by small population sizes and low genetic diversity, as the Huachuca/Canelo Hills population has less than 20 known localities, each with observed breeding populations of 2-30 individuals. Taken together, these threats are of high magnitude, particularly in Arizona. The threats are also imminent or ongoing, particularly the threat of catastrophic wildfire; there have been several recent catastrophic fires in the Huachuca Mountains. Therefore, we have assigned an LPN of 3 to this population. Fish Laurel dace ( *Phoxinus saylori* )—The laurel dace is a rare minnow known only from three independent systems on the Walden Ridge section of the Cumberland Plateau, including Soddy Creek, Sale Creek, and Piney River. The primary threats to the laurel dace stem from impacts to riparian and instream habitat resulting from incompatible land uses. The riparian habitats associated with some streams occupied by laurel dace have been affected by extensive timber removal activities on Walden Ridge in their vicinity; these activities often do not employ adequate streamside management zones or best management practices for road construction. Proposed projects, including installation of a water line that would cross occupied streams and construction of an impoundment on a tributary to an occupied stream, present additional direct and indirect threats to laurel dace habitat in the headwaters of Sale and Soddy creeks. We believe that the threat of habitat degradation from siltation across the range of laurel dace and the localized threats facing populations in Sale and Soddy creeks combined with vulnerable status of the populations in Soddy and Sale creeks constitute threats collectively of high magnitude, but are nonimminent. Therefore, we assigned the laurel dace an LPN of 5. Snails San Bernardino springsnail ( *Pyrgulopsis bernardina* )—This species is endemic to one natural spring, Snail Spring, on private lands, and one artificial spring, Tule Spring, on National Wildlife Refuge lands, in the Rio Yaqui basin of Cochise County, Arizona. The species was formerly known from six to eight springs. Known threats include water diversion, spring modification, and contaminants, while suspected threats include livestock grazing and groundwater depletion. The San Bernardino National Wildlife Refuge is actively managing Tule Spring and is attempting to acquire the property containing Snail Spring. However, the Refuge cannot address the potential threat from groundwater depletion without assistance from local stakeholders. The magnitude of threats is high because the limited distribution of this narrow endemic makes any catastrophic event likely to result in extinction of the species. The threats are ongoing and therefore imminent. Thus, we have assigned an LPN of 2 for the San Bernardino springsnail. Insects Casey's June beetle ( *Dinacoma caseyi* )—We previously announced candidate status for this species in a separate warranted but precluded 12-month petition finding published on July 5, 2007 (72 FR 36635). Plants *Eriogonum corymbosum* var. *nilesii* (Las Vegas buckwheat)—The following information is based on information contained in our files. The Las Vegas buckwheat is a woody perennial shrub up to 4 feet high with a mounding shape. The flowers of this plant are numerous, small and yellow with small bract like leaves at the base of each flower. The Las Vegas buckwheat is very conspicuous when flowering in late September and early October. It is restricted to gypsum soil outcroppings in Clark and Lincoln Counties, Nevada. Only recently has the taxonomy of the subspecies been confirmed using molecular genetic analyses. Loss of habitat from development is a significant threat with over 95 percent of the historic range and potential habitat of the subspecies lost to development. In 2005, the Las Vegas buckwheat was known from nine locations on approximately 1,149 acres. However, since that time, approximately 289 acres were or soon will be developed, and the current distribution of the plant occupies 892 acres. In addition, OHV activity and other public land uses (casual public use, mining, and dumping) directly and indirectly threaten over half of the remaining habitat. To date, regulatory mechanisms to protect the Las Vegas buckwheat are inadequate. Its designation as a BLM special status species and limited resource and law enforcement personnel has not provided adequate protection on lands managed by the BLM. The Las Vegas buckwheat is not protected by the State of Nevada or any other regulatory mechanisms on other federal lands. We have determined that candidate status is warranted for the Las Vegas buckwheat as a result of threats to the remaining 892 acres of Las Vegas buckwheat. Conservation measures are being developed that could reduce the amount of occupied habitat at risk, but we believe it would be premature to consider these measures sufficiently complete as to remove these threats. The magnitude of threats is high since the more significant threats (development and surface mining) would result in direct mortality of the plants in over half of its' habitat. While both development and mining are very likely to occur in the future, they are not expected to happen in the immediate future, and thus, the threats are nonimminent. Accordingly, we assigned the Las Vegas buckwheat an LPN of 6. Listing Priority Changes in Candidates We reviewed the LPN for all candidate species and are changing the numbers for the following species. Some of the changes reflect actual changes in either the magnitude or imminence of the threats, and in one case, the LPN change reflects a change in the taxonomy of the species. For some species, our changes in the LPN reflect efforts to ensure national consistency as well as closer adherence to the 1983 guidelines in assigning these numbers, rather than a change in the nature of the threats. Birds Friendly ground-dove, American Samoa DPS ( *Gallicolumba stairi stairi* )—The following summary is based on information contained in our files. The genus *Gallicolumba* is distributed throughout the Pacific and Southeast Asia. The genus is represented in the oceanic Pacific by six species. Three are endemic to Micronesian islands or archipelagos, two are endemic to island groups in French Polynesia, and *G. stairi* is endemic to Samoa, Tonga, and Fiji. All six species have some level of threatened status on the International Union for Conservation of Nature and Natural Resources

(IUCN)Red List. Some authors recognize two subspecies of the friendly ground-dove, one, slightly smaller, in the Samoan archipelago ( *G. s. stairi* ), and one in Tonga and Fiji ( *G. s. vitiensis* ), but morphological differences between the two are minimal. In American Samoa, the friendly ground-dove has been found on the islands of Ofu and Olosega (Manua Group). Threats to this subspecies have not changed over the past year. Of the primary threats to the subspecies (predation by nonnative species and natural catastrophes such as hurricanes), predation by nonnative species is thought to be occurring now, and predation likely has been occurring for several decades. This predation may be an important impediment to increasing the population. Predation by introduced species has played a significant role in reducing, limiting, and extirpating populations of island birds, especially ground-nesters, in the Pacific and other locations worldwide. Nonnative predators known or thought to occur in the range of the friendly ground-dove in American Samoa are feral cats ( *Felis catus* ), Polynesian rats ( *Rattus exulans* ), black rats ( *R. rattus* ), and Norway rats ( *R. norvegicus* ). In January 2004 and February of 2005, hurricanes virtually destroyed the habitat of *G. stairi* in an area on Olosega Island where the species had been most frequently recorded. Although this species has coexisted with severe storms for millennia, this example illustrates the potential for natural disturbance to exacerbate the effect of anthropogenic disturbance on small populations. Consistent monitoring using a variety of methods over the last 5 years yielded few observations of this taxon in American Samoa. The total population size is poorly known, but is unlikely to number more than a few hundred pairs. The past five years or so of surveys have revealed no change in the relative abundance of this taxon in American Samoa. The distribution of the friendly ground-dove is limited to steep, forested slopes with an open understory and a substrate of fine scree or exposed earth; this habitat is not common in American Samoa. We revised the LPN from a 6 to a 9 to better reflect the fact that the threats posed to the friendly ground-dove (its small population size and nonnative predators), while imminent and occurring throughout its range, are believed to be of a moderate magnitude rather than a high magnitude. Kittlitz's Murrelet ( *Brachyramphus brevirostris* )—Kittlitz's murrelet is a small diving seabird whose entire North American population, and most of the world's population, inhabits Alaskan coastal waters discontinuously from Point Lay south to northern portions of Southeast Alaska. Kittlitz's murrelets are associated with tidewater glaciers. The current population estimate for Kittlitz's murrelets in Alaska is approximately 16,700 birds, a decline of 74 to 84 percent during the past 10 to 20 years. New survey information supports and strengthens the negative population trend estimates that have been previously reported. Threats to Kittlitz's murrelets include large-scale processes such as global climate change and marine climate regime shift. These large-scale processes may influence Kittlitz's murrelet survival and reproduction. Glacial retreat, a global phenomenon that affects many of the glaciers with which Kittlitz's murrelets are associated, is associated with changing forage fish availability and may result in increased predation from corvids (retreat of glaciers allows corvids easier access to murrelets on which they prey). Even if the causes of rapid climate warming were curbed today, feedback mechanisms would result in the continued retreat of tidewater glaciers into the foreseeable future. In addition, the declining population trend makes this species particularly susceptible to ongoing threats from other human activities, including oil spills, bycatch in commercial gillnet fisheries, and disturbance by tour boats. Kittlitz's murrelets are believed to have been seriously affected by the *Exxon Valdez* oil spill in Prince William Sound

(PWS)in 1989. Estimates of direct mortality of Kittlitz's murrelets from this oil spill constituted a loss of 7 to15 percent of the PWS population. Catastrophic events such as oil spills could have a significant negative effect on the population of this already diminished species. Susceptibility to mortality as bycatch in commercial fishing could be a significant factor in their population decline; Kittlitz's murrelets are caught in gill nets in numbers disproportionate to their density. In PWS, salmon gillnet fisheries occur each summer in or near Kittlitz's murrelet habitat. Kittlitz's murrelets represented 5 percent and 30 percent of murrelet bycatch in gillnets during 1990 and 1991, respectively. Tour boat visitation to glacial fjords is a growing industry, and this activity may increasingly disrupt Kittlitz's murrelet feeding behavior; tour boats may provide artificial perch sites for avian predators. The number of cruise ships allowed into Glacier Bay has increased 30 percent since 1985, while smaller charter boats and private boats have increased 8 percent and 15 percent, respectively. An increase in tour boat operations has been noted in Kenai Fjords National Park as well. Disturbance can disrupt feeding birds and persistent boat traffic may prevent murrelets from using high quality foraging areas. Based on the observed population trajectory and the severity of present threats (rapid glacial retreat, acute and chronic oil spills, commercial gillnet fishing, and human disturbance from tour boats), the threats to this species are high in magnitude and imminent. We changed the LPN from a 5 to a 2 to reflect that the threats to this species are ongoing. Xantus's murrelet ( *Synthliboramphus hypoleucus* )—The Xantus's murrelet is a small seabird in the Alcid family that occurs along the west coast of North America in the United States and Mexico. The species has a limited breeding distribution, only nesting on the Channel Islands in southern California and on islands off the west coast of Baja California, Mexico. Although data on population trends are scarce, the population is suspected to have declined greatly over the last century, mainly due to introduced predators such as rats ( *Rattus* sp.) and feral cats ( *Felis catus* ) to nesting islands, with extirpations on three islands in Mexico. A dramatic decline (up to 70 percent) from 1977 to 1991 was detected at the largest nesting colony in southern California, possibly due to high levels of predation on eggs by the endemic deer mouse ( *Peromyscus maniculatus elusus* ). Identified threats include introduced predators at nesting colonies, oil spills and oil pollution, reduced prey availability, human disturbance, and artificial light pollution. Although substantial declines in the Xantus's murrelet population likely occurred over the last century, some of the largest threats are being addressed, and, to some degree, ameliorated. Declines and extirpations at several nesting colonies were thought to have been caused by nonnative predators, which have been removed from many of the islands where they once occurred. Most notably, since 1994, Island Conservation and Ecology Group has systematically removed rats, cats, and dogs from every murrelet nesting colony in Mexico, with the exception of cats and dogs on Guadalupe Island. In 2002, rats were eradicated from Anacapa Island in southern California, which has resulted in improvements in reproductive success at that island. In southern California, there are also plans to remove rats from San Miguel Island, and to restore nesting habitat on Santa Barbara Island through the Montrose Settlements Restoration Project, which may benefit the Xantus's murrelet population at those islands. Artificial lighting from squid fishing and other vessels, or lights on islands, remains a potential threat to the species. Bright lights make Xantus's murrelets more susceptible to predation, and they can also become disoriented and exhausted from continual attraction to bright lights. Chicks can become disoriented and separated from their parents at sea, which could result in death of the dependent chicks. High-wattage lights on commercial market squid ( *Loligo opalescens* ) fishing vessels used at night to attract squid to the surface of the water in the Channel Islands was the suspected cause of unusually high predation on Xantus's murrelets by western gulls and barn owls at Santa Barbara Island in 1999. To address this threat, in 2000, the California Fish and Game Commission required light shields and a limit of 30,000 watts per boat; it is unknown if this is sufficient to reduce impacts. Squid fishing has not occurred at a particularly noticeable level near any of the colonies in the Channel Islands since 1999; however, this remains a potential future threat. A proposal to build a liquid natural gas

(LNG)facility 600 meters (1,969 feet) off the Coronados Islands in Baja California, Mexico, was considered a potential major threat to the species. This island contains one of the largest nesting populations of Xantus's murrelets in the world. Potential impacts of this facility to the nesting colony included bright lights at night from the facility and visiting tanker vessels, noise from the facility or from helicopters visiting the facility, and the threat of oil spills associated with visiting tanker vessels. However, Chevron announced in March 2007 that they have abandoned plans to develop this facility and withdrew their permits. LNG facilities are proposed for construction in the Channel Islands; however, these are early in the complex and long-term planning processes; it is possible that none of these facilities will be built. In addition, none of them are directly adjacent to nesting colonies, where their impacts would be expected to be more significant. We considered the LNG facility off the Coronados Islands to be an imminent threat of high magnitude, which resulted in the previous listing priority of a 2. While this proposed LNG facility no longer poses a threat, the remaining threats, in particular oil spills, are high in magnitude since they have the potential to cause direct mortality and reduce reproductive success throughout a majority of the species' range. The threats are nonimminent since they are not currently occurring. Therefore, we have changed the LPN from a 2 to a 5. Reptiles Louisiana pine snake ( *Pituophis ruthveni* )—The Louisiana pine snake

(LPS)historically occurred in fire-maintained longleaf-pine ecosystems of west-central Louisiana and extreme east-central Texas. Those ecosystems provided an herbaceous layer necessary to maintain the Louisiana pine snake's primary prey, the Baird's pocket gopher. Current potentially occupied habitat in Louisiana and Texas is estimated to be approximately 300,000 acres, with 70 percent occurring on public lands and 30 percent in private ownership. Results of trapping and radio-telemetry surveys suggest that extensive population declines and local extirpations have occurred during the last 50 to 80 years. To address those issues on public lands, a Candidate Conservation Agreement

(CCA)was completed in 2003 to maintain and enhance potentially occupied habitat, and protect known Louisiana-pine-snake populations. Much of the public land is now being managed on longer rotations (i.e., 70+ years) where silvicultural prescriptions include smaller clearcuts, midstory removal, thinning, and prescribed fire. Private lands generally are not managed to support the longleaf-pine ecosystem and its characteristic herbaceous layer; however, several private landowners with known Louisiana-pine-snake populations continue to be involved in conservation efforts with reported conservation of more than 2,000 acres in 2006. Within both the public and private sectors, interest in longleaf-pine restoration appears to be growing and with the appropriate emphasis could slow or reverse habitat loss trends. To address this and other issues, the LPS Conservation Group is expanding conservation efforts through the development of a Comprehensive Conservation Plan that would build upon the CCA success. Other factors affecting Louisiana pine snakes throughout its range include low fecundity, which magnifies other threats and increases the likelihood of local extinctions, and vehicular mortality, which can significantly affect Louisiana-pine-snake population and community structure. While the magnitude of Louisiana-pine-snake habitat loss has been great in the past and the remaining habitat is degraded, habitat loss does not represent an imminent threat, because the rate of habitat loss is declining. Additionally, pro-active partnerships to address key management concerns and research needs are resulting in some additional long-leaf pine habitat that is suitable for the Louisiana pine snake or its prey species. However, while conservation actions have produced needed results, they have not yet adequately reduced threats to the species, particularly on private land. The lack of adequate habitat still poses a threat and when coupled with the very low fecundity rate and extremely low population size (based on capture rates and population estimates) make the threat high in magnitude. Overall, due to nonimminent, high-magnitude threats, we changed the LPN from an 8 to a 5 for this species. Amphibians Columbia spotted frog, Great Basin DPS ( *Rana luteiventris* )—Currently, Columbia spotted frogs appear to be widely distributed throughout southwestern Idaho, eastern Oregon, and northeastern and central Nevada, but local populations within these general areas appear to be small and isolated from each other. Recent work by researchers in Idaho and Nevada has documented loss of historically known sites, reduced numbers of individuals within local populations, and declines in the reproduction of those individuals. Small highly fragmented populations, characteristic of the majority of existing populations of Columbia spotted frogs in the Great Basin, are highly susceptible to extinction processes. Threats to Columbia-spotted-frog habitat, including water development, improper grazing, mining activities and non-native species, have and continue to contribute to the degradation and fragmentation of habitat. Emerging fungal diseases, such as chytridiomycosis, and the spread of parasites are contributing factors to Columbia-spotted-frog population declines throughout portions of its range. Effects of climate change such as drought and stochastic (randomly occurring) events such as fire often have detrimental effects to small isolated populations and can often exacerbate existing threats. A 10-year Conservation Agreement and Strategy was signed in September 2003 for both the Northeast and the Toiyabe subpopulations in Nevada. The goals of the conservation agreements are to reduce threats to Columbia spotted frogs and their habitat to the extent necessary to prevent populations from becoming extirpated throughout all or a portion of their historic range and to maintain, enhance, and restore a sufficient number of populations of Columbia spotted frogs and their associated habitat to ensure their continued existence throughout their historical range. Additionally, a Candidate Conservation Agreement with Assurances was completed in 2006 for the Owyhee subpopulation at Sam Noble Springs, Idaho. Because these conservation agreements have reduced the magnitude of the imminent threats from high to moderate, we changed the LPN from a 3 to a 9 for this DPS of the Columbia spotted frog. Black Warrior waterdog ( *Necturus alabamensis* )—The Black Warrior waterdog is a salamander that inhabits streams above the Fall Line within the Black Warrior River Basin in Alabama. There is very little specific locality information available on the historical distribution of the Black Warrior waterdog since little attention was given to this species between its description in 1937 and the 1980s. At that time, there were a total of only 11 known historical records from 4 Alabama counties. Two of these sites have now been inundated by impoundments. Extensive survey work was conducted in the 1990s to look for additional populations. Currently, the species is known from 14 sites in 5 counties. Water-quality degradation is the biggest threat to the continued existence of the Black Warrior waterdog. Most streams that have been surveyed for the waterdog showed evidence of pollution and many appeared biologically depauperate. Sources of point and nonpoint pollution in the Black Warrior River Basin have been numerous and widespread. Pollution is generated from inadequately treated effluent from industrial plants, sanitary landfills, sewage treatment plants, poultry operations, and cattle feedlots. Surface mining represents another threat to the biological integrity of waterdog habitat. Runoff from old, abandoned coal mines generates pollution through acidification, increased mineralization, and sediment loading. The North River, Locust Fork, and Mulberry Fork, all streams that this species inhabits, are on the Environmental Protection Agency's list of impaired waters. An additional threat to the Black Warrior waterdog is the creation of large impoundments that have flooded thousands of square hectares (acres) of its habitat. These impoundments are likely marginal or unsuitable habitat for the salamander. While the water-quality threat is pervasive and problematic, the overall magnitude of the threat is moderate as there has not been a steep rate of decline in this species population. Water quality degradation in the Black Warrior basin is ongoing; therefore, the threats are imminent. We changed the LPN from a 2 to an 8 for this species since the threats are of a moderate rather than high magnitude. Clams Fluted kidneyshell ( *Ptychobranchus subtentum* )—The fluted kidneyshell is a freshwater mussel (Unionidae) endemic to the Cumberland and Tennessee River systems (Cumberlandian Region) in Alabama, Kentucky, Tennessee, and Virginia. It requires shoal habitats in free-flowing rivers to survive and successfully recruit new individuals into its populations. This species has been extirpated from numerous regional streams and is no longer found in the State of Alabama. Habitat destruction and alteration (e.g., impoundments, sedimentation, and pollutants) are the chief factors that contributed to its decline. The fluted kidneyshell was historically known from at least 37 streams but is currently restricted to no more than 12 isolated populations. Current status information for most of the 12 populations deemed to be extant is available from recent periodic sampling efforts (sometimes annually) and other field studies, particularly in the upper Tennessee River system. Some populations in the Cumberland River system have had recent surveys as well (e.g., Wolf, Little Rivers; Little South Fork; Horse Lick, Buck Creeks). Populations in Buck Creek, Little South Fork, Horse Lick Creek, Powell River, and North Fork Holston River have clearly declined over the past two decades. Based on recent information, the overall population of the fluted kidneyshell is declining rangewide and the species remains in large numbers and is clearly viable in just the Clinch River/Copper Creek, although smaller, viable populations remain (e.g., Wolf, Little, North Fork Holston Rivers; Rock Creek). Most other populations are of questionable or limited viability, with some on the verge of extirpation (e.g., Powell River; Little South Fork; Horse Lick, Buck, Indian Creeks). Newly reintroduced populations in the Nolichucky and Duck Rivers will hopefully begin to reverse the downward population trend of this species. The threats are high in magnitude since all populations of this species are severely affected by numerous threats (impoundments, sedimentation, small population size, isolation of populations, gravel mining, municipal pollutants, agricultural run-off, nutrient enrichment, and coal processing pollution) which results in mortality and/or reduced reproductive output. Since the threats are ongoing, they are imminent. Therefore, to help ensure consistency in the application of our listing priority process, we changed the LPN from a 5 to a 2 to reflect that the threats are imminent and high in magnitude. Snails Black mudalia ( *Elimia melanoides* )—The black mudalia is a small species of aquatic snail found clinging to clean gravel, cobble, boulders and/or logs in flowing water on shoals and riffles. The historical habitat of the black mudalia included much of the upper Black Warrior River drainage above the Fall Line at Tuscaloosa, Alabama. The species has been extirpated from more than 80 percent of that range through the construction of dams and impoundments, sedimentation, and non-point source pollution from land surface runoff. Populations that may have avoided impoundment apparently disappeared due to historical pollution events and/or natural catastrophic events. However, after being considered extinct for two decades, the black mudalia was rediscovered in a small portion of its historical range in the Black Warrior drainage. Discovery of surviving populations in shoals of five streams in the upper Black Warrior River and high densities reported at Blackburn Fork reduce the magnitude of the threats from high to moderate. However, all known populations are currently affected by point and/or non-point source pollution; human land uses, including cattle grazing, row crops, timber, chicken farms, and home construction are currently causing sedimentation and eutrophication (reduction of oxygen in the water) of black mudalia habitats. Thus, based on ongoing threats that we now consider to be moderate in magnitude, we changed the LPN from 2 to 8 for the black mudalia. Huachuca springsnail ( *Pyrgulopsis thompsoni* )—The following summary is based on information from our files. No new information was provided in the petition received on May 11, 2004. The Huachuca springsnail inhabits 13 springs and ciénegas at elevations of 4,500 to 7,200 feet in southeastern Arizona (11 sites) and adjacent portions of Sonora, Mexico (2 sites). The springsnail is typically found in the shallower areas of springs or cienegas, often in rocky seeps at the spring source. Ongoing threats include habitat modification, wildfire, cattle grazing, and groundwater pumping. Prior communication with personnel from Fort Huachuca indicated they were in the process of evaluating the status of this species on Department of Defense lands and developing conservation strategies; this may result in a reduction or elimination of threats in the future. Because we determined that the proportion of the range subjected to various threats is smaller than we previously determined, the threats are moderate in magnitude. In addition, although there is no actual change in threats over the past year, modification of the spring habitat, wildfire, cattle grazing, and groundwater pumping are ongoing or imminent threats. Therefore, to help ensure consistency in the application of our listing priority process, we changed the LPN from a 5 to an 8 to reflect that the threats are imminent but are moderate in magnitude. Page springsnail ( *Pyrgulopsis morrisoni* )—The following summary is based on information from our files. No new information was provided in the petition received on May 11, 2004. The Page springsnail is known to exist only within a complex of springs located within an approximately 1.5-kilometer (0.93-mile) stretch along the west side of Oak Creek around the community of Page Springs, Yavapai County, Arizona. Many of the springs where the springsnail occurs have been subjected to some level of modification for domestic, agricultural, ranching, fish hatchery, and recreational activities. Arizona Game and Fish Department management plans for the Bubbling Ponds and Page Springs fish hatcheries include commitments to replace lost habitat and to monitor remaining populations of invertebrates such as the Page springsnail. The Arizona Game and Fish Department and the Service have made significant progress on development of a candidate conservation agreement, but the effectiveness of planned and implemented actions has not been demonstrated. Based on recent survey data, it appears that the Page springsnail is abundant within natural habitats and persists in modified habitats, albeit at reduced densities. The magnitude of threats is considered high because limited distribution of this narrow endemic makes any detrimental effects from threats likely to result in extirpation or extinction. The immediacy of the threat of groundwater withdrawal is uncertain due to conflicting information that suggests it may be either imminent or not. However, overall, the threats are imminent because the majority of them are currently occurring. Although there is no actual change in threats over the past year, modification of the spring habitat for this species is an ongoing or imminent threat. Therefore, to help ensure consistency in the application of our listing priority process, we changed the LPN from a 5 to a 2 to reflect that the threats are imminent. Insects Dakota skipper ( *Hesperia dacotae* )—The following summary is based on information contained in our files, including information from the petition we received on May 12, 2003. The Dakota skipper is a small- to mid-sized butterfly that inhabits high-quality tallgrass and mixed grass prairie in Minnesota, North Dakota, South Dakota, and the provinces of Manitoba and Saskatchewan in Canada. The species is presumed to be extirpated from Iowa and Illinois and from many sites within occupied States. The species is threatened by conversion of its native prairie habitat for agricultural purposes, overgrazing, invasive species, gravel mining, inbreeding, population isolation, and, in some cases, prescribed fire. Prairie succeeds to shrubland or forest without periodic fire, grazing, or mowing; thus, the species is also threatened at sites where such disturbances are not applied. We, other agencies, and private organizations (e.g., The Nature Conservancy) protect and manage some Dakota skipper sites. Although proper management is always necessary to ensure its persistence, even at protected sites, it is secure at some sites owned by these entities. The species is also secure at some sites where private landowners manage native prairie in ways that conserve Dakota skipper. Recent surveys in at least parts of the species' range have led us to revise our view of the imminence of threats to Dakota skipper. In January 2007, for example, Minnesota Department of Natural Resources proposed revising the status of Dakota skipper in the state from threatened to endangered because it “appears to be rapidly disappearing from remnant habitat.” In addition, approximately half of the inhabited sites are privately owned with little or no protection. Ongoing threats on these sites include invasive species, overgrazing, and herbicide applications. A few private sites are protected from conversion by easements, but these do not prevent adverse effects from overgrazing. The threats are such that the species warrants listing; the threats are moderate in magnitude and, based on the above new information, are imminent. Therefore, we changed the listing priority number from an 11 to an 8 for the Dakota skipper to reflect the increase in immediacy of threats to remnant habitat, particularly on private lands. Coral Pink Sand Dunes tiger beetle ( *Cicindela albissima* )—The Coral Pink Sand Dunes tiger beetle occurs only at the Coral Pink Sand Dunes, approximately 7 miles west of Kanab, Kane County, in south-central Utah. It is restricted to a small part of the dune field, situated at an elevation of about 1,820 m (6,000 ft). The beetle's habitat is being adversely affected by ongoing recreational off-road vehicle use that is destroying and degrading the beetle's habitat, especially the interdunal swales used by the larvae. The continued survival of the beetle depends on the preservation of its habitat. The two agencies that manage the dune field, the Utah Department of Parks and Recreation and the Bureau of Land Management, have restricted recreational off-road vehicle use in some areas, which reduces impacts. However, the protected areas may not be of sufficient size to enable the population to increase in size. The beetle's population is also vulnerable to overcollecting by professional and hobby tiger-beetle collectors. Because the taxon was recently elevated to a full species based on genetic research, we changed the listing priority from a 9 to an 8. The imminence and magnitude of the threats remain the same (imminent and moderate to low magnitude). Stephan's riffle beetle ( *Heterelmis stephani* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Stephan's riffle beetle is an endemic riffle beetle found in limited spring environments within the Santa Rita Mountains, Pima County, Arizona. The beetle is known from Bog Spring and Sylvester Spring in Madera Canyon, within the Coronado National Forest. These springs are typical isolated, mid-elevation, permanently saturated, spring-fed aquatic climax communities commonly referred to as ciénegas. Threats are largely from habitat modification (from recreational activities in the springs and changes in water chemistry due to catastrophic natural disasters such as fires or floods); we consider them to be of moderate to low magnitude due to the lack of focused studies to evaluate the permanence of threats or the likelihood of persistence of the species in areas that are unaffected. Furthermore, because the threats are currently occurring, they are best characterized as imminent. Due to moderate to low magnitude of imminent threats, we changed the LPN from a 5 to an 8 for Stephan's riffle beetle. Crustaceans *Typhlatya monae* (troglobitic groundwater shrimp)— *Typhlatya monae* is a subterranean small shrimp known from Puerto Rico, Barbuda, and Dominican Republic. It is classified as a troglobite, or obligatory cave organism, of which its most extraordinary feature is the reduction or loss of vision and pigmentation. It feeds on organic waste material and debris, such as bat guano. Little is known concerning the status of *Typhlatya monae* in either Barbuda or Dominican Republic. Although in Puerto Rico this species was previously found at Mona Island, currently *Typhlatya monae* is known from only three caves within the Guánica Commonwealth Forest in the municipalities of Guánica, Yauco, and Guayanilla. However, the species may still be found in the reef deposit aquifers in Mona Island that have not yet been surveyed. In 1995, close to 2,000 individuals were estimated; over 95 percent of these were observed in only one cave. Although no systematic censuses have been conducted since 1995, we have recently documented the presence of the species in all three caves and obtained information regarding another cave in which the species may occur from Puerto Rico Commonwealth Forest personnel. Changes in groundwater quality, collection of rare animals, predation, limited distribution of the species, limited availability of appropriate habitat (i.e., underground aquifers within cave formations), potential reduction of food sources (e.g., mortality or reduction in bat populations), and low population numbers potentially threaten populations of *Typhlatya monae.* However, because the known range of *Typhlatya monae* is within protected lands, and because we have received new information of known management activities within the Guánica Commonwealth Forest or Mona Island (activities are managed such that some of the threats to this species no longer exist; e.g. the caves are closed to visitors), we now consider the magnitude of the remaining threats (possible extraction of ground-water in Mona and vulnerability to catastrophic events) moderate to low. Therefore, we changed the LPN from a 5 to an 11 for this species. Flowering plants *Abronia alpina* (Ramshaw Meadows sand-verbena)— *Abronia alpina* is a small perennial herb, 2.5 to 15.2 centimeters (1 to 6 inches) across which forms compact mats with lavender-pink, trumpet-shaped, and generally fragment flowers. *Abronia alpina* is known from one main population center in Ramshaw Meadow on the Kern Plateau of the Sierra Nevada, California, and from one subpopulation found in adjacent Templeton Meadow. The total estimated area occupied is approximately 6 hectares (15 acres). The population fluctuates from year to year without any clear trends. Population estimates from 1985-1994 range from a low of 69,652 plants in 1986 to 132,215 plants in 1987. Surveys conducted since 1994 indicate that no significant changes have occurred in population size or location, although, the 2003 survey showed population numbers to be at the low end of the range. The population was last monitored in 2006. The threats currently facing *Abronia alpina* include natural and human habitat alteration, hydrologic changes to the water table, and recreational use within meadow habitats. Lodgepole pine encroachment has altered the meadow and becoming established within *A. alpina* habitat. Lodgepole pine encroachment may alter soil characteristics by increasing organic matter levels, decreasing porosity, and moderating diurnal temperature fluctuations thus reducing the competitive ability of *A. alpina* to persist in an environment more hospitable to other plant species. The Ramshaw Meadow ecosystem is subject to potential alteration by lowering of the water table due to downcutting of the South Fork of the Kern River (SFKR). The SFKR flows through Ramshaw Meadow, at times coming within 15 m (50 ft) of *A. alpina* habitat, particularly in the vicinity of five subpopulations. The habitat occupied by *A. alpina* directly borders the meadow system supported by the SFKR. Drying out of the meadow system could potentially affect *A. alpina* pollinators and/or seed dispersal agents. Established hiker, packstock, and cattle trails pass through *A. alpina* subpopulations. Two main hiker trails pass through Ramshaw Meadow, but were rerouted out of *A. alpina* subpopulations where feasible, in 1988 and 1997. Remnants of cattle trails that pass through subpopulations in several places receive occasional incidental use by horses and sometimes hikers. Cattle use, however, currently, is not a threat due to the 2001 implementation of a ten-year moratorium on the Templeton allotment which prohibits cattle from all *A. alpina* locations. In 2007, the U.S. Forest Service in cooperation with the Service drafted a Conservation Agreement for *A. alpina* that would provide protective measures via increased management of recreation in the area, habitat management, and research on *A. alpina.* Approval and finalization of this Agreement is anticipated in Fiscal Year 2008. The Service is funding studies to determine appropriate conservation measures. As a result of rerouting hiking trails, curtailing grazing, and development of a Conservation Agreement between the U.S. Forest Service and the Service the threats facing *Abronia alpina* have been reduced. Because the population is stable and the threats have been reduced, we changed the LPN for *A. alpina* from an 8 to an 11, reflecting nonimminent threats that are moderate to low in magnitude. *Bidens campylotheca* ssp. *waihoiensis* (Kookoolau)—Kookoolau is an erect, perennial found in wet *Acacia-Metrosideros* (koa-ohia) forest on Maui, Hawaii. *Bidens campylotheca* ssp. *waihoiensis* is known from 1 and possibly 2 populations, 1 of 200 individuals, and the second of possibly as many as 300 individuals. It is threatened by feral pigs and cattle, which eat this plant and degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Conservation measures such as strategic fences and control of nonnative plants benefit the plants in Kipahulu Valley; however, the individuals in Waihoi Valley are still affected by these threats. Therefore, to reflect the fact that the threats are ongoing, we have changed the LPN for this species from a 6 to a 3. *Chamaecrista lineata* var. *keyensis* (Big Pine partridge pea)—This pea is endemic to the lower Florida Keys, and restricted to pine rocklands, hardwood hammock edges, and roadsides and firebreaks within these ecosystems. Historically, it was known from Big Pine, No Name, Ramrod, and Cudjoe Keys (Monroe County, Florida). It presently occurs on Big Pine, plus two very small populations found on Cudjoe and lower Sugarloaf Keys in 2005. It is fairly well distributed in Big Pine Key pine rocklands, which encompass approximately 580 hectares (1,433 acres). Roughly 90 percent of its current range is within the Service's National Key Deer Refuge. In late 2005, it occurred within 37.2 percent of 541 plots sampled throughout the publicly owned pine rocklands on Big Pine Key. Frequency of occurrence was twice as great and density over 3 times greater in the less fragmented, more fire-prone northern portion of Big Pine Key than the southern part. Pine rockland communities are maintained by relatively frequent fires. In the absence of fire, shrubs and trees encroach on pine rockland and the pea is eventually shaded out. The National Key Deer Refuge

(NKDR)has a prescribed fire program, though with many constraints on implementing fire. Absence of fire is the greatest of the short-term and deterministic threats. Hurricanes are also a threat. Hurricane Wilma (October 2005) resulted in a storm surge that covered most of Big Pine Key with sea water. In plots sampled after Wilma, frequency of occurrence decreased to less than a third and density decreased to less than half that found in plots sampled before Wilma. The magnitude of threats to the Big Pine partridge pea is moderate. Partridge pea has a very limited distribution that is somewhat fragmented and fire limitation, salt water storm surges (direct mortality, as well as slash pine mortality, associated with hurricanes), and pollinator limitation, constitute significant threats. Additionally, threats from storm surges associated with hurricanes are exacerbated by sea level rise. Big Pine partridge pea exists as one relatively large population (possibly fragmented into a metapopulation) on Big Pine Key and two very small, isolated populations on two other keys. However, population size is on the order of several hundred thousand, and the majority occurs on the NKDR. Over the long run, partridge pea receives protective measures only on NKDR and the Terrestris Preserve. The immediacy of threats is imminent as the probability of intense hurricanes has increased in recent years, and increasingly sea levels have exacerbated the threat. Additionally, storm surges have complicated efforts to conduct prescribed fires. If the frequency of prescribed fire does not increase, the imminence of threats due to fire suppression will continue to increase. Because the threats are moderate rather than high in magnitude due to some protection from threats provided by the NKDR and Terrestris Preserve, we changed the LPN from a 6 to a 9 for the Big Pine partridge pea. *Chamaesyce deltoidea* ssp. *serpyllum* (Wedge spurge)—New survey results were obtained in March 2006. Wedge spurge is a small, prostrate herb. It has always been restricted to Big Pine Key in Monroe County, Florida. Most of the range falls within the National Key Deer Refuge. It is restricted to pinelands on limestone rock (pine rockland), at sites with exposed rock or gravel, low understory cover, and low hardwood density. Pine rocklands encompass approximately 580 hectares (1,433 acres) on Big Pine Key. It is not widely dispersed within the limited range. In late 2005, it occurred within 7.4 percent of 541 plots sampled throughout the publicly owned pine rocklands on Big Pine Key. Hurricane Wilma (October 2005) resulted in a storm surge that covered most of Big Pine Key with sea-water. Before and after Wilma, it occurred in 9.3 of 332 sample plots and 4.3 percent of 209 sample plots, respectively, and density decreased significantly within plots. Occupied plots had become restricted to the higher, middle portion of Big Pine Key. In the absence of fire, shrubs and trees encroach on pine rockland and spurge is eventually shaded out. The magnitude of threats to the wedge spurge is moderate. Wedge spurge has a narrow distribution composed of few occurrences, and threats result from lack of fire, hurricanes, sea level rise, and invasive exotic plants. Additionally, threats from storm surges associated with hurricanes are exacerbated by sea-level rise. Wedge spurge exists essentially as a single (fragmented) population on Big Pine Key, which over the long run is protected only on NKDR and the Terrestris Preserve. However, population size is on the order of several hundred thousand, and the majority occurs on the NKDR. The National Key Deer Refuge has a prescribed fire program, though with many constraints on implementing fire. The threats to the wedge spurge are imminent. The best available information indicates that this plant is intrinsically vulnerable to extinction because it is a narrow endemic. Moreover, the threats of hurricanes and shading due to lack of fire are ongoing. However, because the threats are moderate rather than high in magnitude due to some protection from threats provided by the NKDR and Terrestris Preserve, we changed the LPN from a 6 to a 9 for the wedge spurge. *Cordia rupicola* (no common name)— *Cordia rupicola,* a small shrub, has been described from southwestern Puerto Rico (Peñuelas and Guánica), Vieques Island, and Anegada Island (British Virgin Islands). *Cordia rupicola* is restricted to subtropical dry forest life zone overlying a limestone substrate. At present time, less than 20 individuals of *C. rupicola* are currently known from four sites in Puerto Rico; only a few individuals are located in protected lands managed for conservation by the Puerto Rico Department of Natural and Environmental Resources or the Service. The area that contains 83 percent of the known population is located in a privately-owned property and is threatened by habitat destruction or modification. While the population on Anegada Island is currently stable, this population is threatened by potential residential and commercial development. Both populations are also vulnerable to natural (e.g., hurricanes) or manmade (e.g., human-induced fires) threats. All sites are located in a xeric environment vulnerable to human-induced fires which could destroy entire populations. For these reasons, the magnitude of the current threats is high. While hurricanes and fire do occur, the rate of occurrence is such that they do not pose an imminent threat. The threats this species faces are ones that will arise in the future if conservation measures are not implemented and long-term impacts are not averted. For these reasons, the threats to the species as a whole are nonimminent, and therefore, we changed the LPN from a 2 to a 5 for this species. *Dalea carthagenensis floridana* (Florida prairie-clover)— *Dalea carthagenensis floridana* occurs in Big Cypress National Preserve in Monroe and Collier Counties, Florida. It is also known from small populations in Miami-Dade County. There are a total of nine extant occurrences, most of which are on conservation land. Existing occurrences are extremely small and may not be viable, especially those in Miami-Dade County. Remaining habitats are fragmented. This plant is threatened by habitat loss and habitat degradation due to fire suppression, the difficulty of applying prescribed fire to pine rocklands, and threats from exotic plants. Damage to plants by off-road vehicles is a serious threat within the Big Cypress National Preserve; the threat from illegal mountain biking at the R. Hardy Matheson Preserve has been reduced. This species is being parasitized by the introduced insect lobate lac scale at some localities (e.g., R. Hardy Matheson Preserve), but we do not know the extent of this threat. This plant is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges. Due to its restricted range and the small sizes of most isolated occurrences, this species is vulnerable to environmental (catastrophic hurricanes), demographic (potential episodes of poor reproduction), and genetic (potential inbreeding depression) threats. After a thorough review of the species status and threats, the magnitude of threats is high and threats are imminent because of the limited number of occurrences and the small number of individual plants at each occurrence. In addition, even though many sites are on conservation lands, these plants still face significant ongoing threats. Therefore, we have changed the LPN from 9 to 3 for this subspecies. *Echinomastus erectocentrus* var. *acunensis* (Acuna cactus)—The following summary is based on information contained in our files and the petition we received on October 30, 2002. The Acuna cactus is known from six sites on well-drained gravel ridges and knolls on granite soils in Sonoran Desert scrub association at 1300-2000 feet elevation. Habitat destruction has been a threat in the past and is a potential future threat to this species. New roads and illegal activities have not yet directly affected the cactus populations at Organ Pipe Cactus National Monument, but areas in close proximity to these known populations have been altered. Cactus populations located in the Florence area have not been monitored, and these populations may be in danger of habitat loss due to recent urban growth in the area. Urban development near Ajo, Arizona, as well as that near Sonoyta, Mexico, is a significant threat to the Acuna cactus. Populations of the Acuna cactus within the Organ Pipe Cactus National Monument have shown a 50-percent mortality rate in recent years. The reason(s) for the mortality are not known, but continuing drought conditions are thought to play a role. The Arizona Plant Law and the Convention on International Trade in Endangered Species of Wild Fauna and Flora provide some protection for the Acuna cactus. However, illegal collection is a primary threat to this cactus variety and has been documented on the Organ Pipe Cactus National Monument in the past. The threats continue to be of a high magnitude. The threats are now imminent, as evidenced by the continued decline of the species, most likely from effects from the on-going drought. Conditions in 2006 worsened, and the drought is prevalent throughout the range of this variety. For this reason, we believe that the main threat, drought, is on-going and is a significant threat to the long-term viability of this variety. Thus, we changed the LPN from a 6 to a 3 for this cactus variety. *Geranium hanaense* (Nohoanu)—This species is a decumbent shrub found in bogs on Maui, Hawaii. This species is known from two adjacent bogs totaling 300 to 500 individuals. *Geranium hanaense* is threatened by pigs that degrade and destroy habitat, and by nonnative plants that outcompete and displace it. However, feral pigs have been fenced out of and removed from both bogs in which this species currently occurs, and a control program has reduced nonnative plants in all fenced areas. Given that the threats to the only known populations of this species are currently being managed and the populations are routinely monitored, this changes the overall magnitude of these threats to moderate. The threats are imminent, however, because the fences must be routinely monitored and nonnative plants must continually be controlled. Therefore, we have changed the LPN for this species from a 5 to an 8. *Helianthus verticillatus* (whorled sunflower)—The following information is based on information contained in our files. The whorled sunflower is found in moist, prairie-like openings in woodlands and along adjacent creeks. Despite extensive surveys throughout its range, only five populations are known for this species from seven sites. There are two populations documented for Cherokee County, Alabama; one in Floyd County, Georgia; and one each in Madison and McNairy Counties, Tennessee. This species appears to have restricted ecological requirements and is dependent upon the maintenance of prairie-like openings for its survival. Active management of habitat is needed to keep competition and shading under control. Much of its habitat has been degraded or destroyed for agricultural, silvicultural, and residential purposes; timber harvest remains a potential threat for the Alabama populations. We changed the priority number from an 11 to a 5 to reflect a high magnitude of threat based on current information. The 11 was assigned previously because the magnitude of threat was then moderate since information at that time indicated that the Georgia site, which is permanently protected, was the largest population, had thousands of plants, and was thriving. New information indicates that this Georgia site actually only harbors 15 to 20 individuals and that plants at this site appear to have low fitness as indicated by their shorter stature and the absence of flowering in this population. The remaining four populations are all on private land with no protection at this time. However, the threats are still nonimminent though since efforts are actively underway to obtain protection for these sites and habitat conversion and timber harvesting are not currently affecting the species. *Phacelia stellaris* (Brand's phacelia)— *Phacelia stellaris* is an annual plant in the Hydrophyllaceae (water-leaf family). Plants are spreading to erect, 6 to 25 cm (2.5 to 10 in) tall. *Phacelia stellaris* was historically found in Los Angeles, Riverside, and San Diego Counties and in coastal northern Baja California, Mexico. Approximately 50 percent of the linear extent of the coastal occurrences of this species has been lost, presumably to urbanization and habitat degradation. The last documentation of the range of the species in Mexico was in 1975. In the United States, four of the five known extant occurrences are from coastal San Diego County, California, in the following areas: Marine Corps Base Camp Pendleton, Silver Strand in the City of San Diego, within a few hundred yards of the Mexican border at Lichty Mesa, and the recently rediscovered population at Coronado Island on Naval Air Station North Island. The only other known extant occurrence is in western Riverside County, southwest of Fairmont Park. Potential threats to the U.S. occurrences include: The anticipated Border Fence project, development or agricultural activities, trampling from humans and equestrian traffic, disturbances from management actions, and invasive nonnative plants. Three of the five populations are very small (tens to low-hundreds) and small populations are considered subject to random events and genetic constraints. This species faces high magnitude threats, but the efforts of land managers and other regulatory mechanisms have resulted in the threats being nonimminent. Therefore, because overall, the threats are nonimminent, we changed the LPN for this species from a 2 to a 5. *Phyllostegia floribunda* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is an erect subshrub found in mesic to wet forest on the island of Hawaii, Hawaii. This species is known from 10 locations totaling fewer than 270 naturally occurring and outplanted individuals on State, private, and Federal lands. *Phyllostegia floribunda* is threatened by feral pigs that degrade and destroy habitat, and nonnative plants that compete for light and nutrients. The Park Service, The Nature Conservancy of Hawaii, and the State have outplanted over 170 individuals at Olaa Forest Reserve, Kona Hema, and Waiakea Forest Reserve (greater than 50, 20 individuals, and 100 individuals, respectively). Fences protect approximately seven populations on private, State, and Park Service lands. Nonnative plants have been reduced in these fenced areas. However, no conservation efforts have been implemented for the unfenced populations. Because these threats are of imminent, but only moderate magnitude for the majority of the populations, we changed the LPN from a 2 to an 8. *Sideroxylon reclinatum* ssp. *austrofloridense* (Everglades bully)—Everglades bully occurs on pinelands, pineland/prairie ecotones, and prairies in Everglades National Park and private lands in Miami-Dade County, and Big Cypress National Preserve in Monroe County, Florida. Pine rocklands in Miami-Dade County have largely been destroyed by residential, commercial, and urban development and agriculture. Most remaining suitable habitat for this plant has been negatively altered by human activity. While privately owned pine rocklands are at risk from development, habitat for this plant is, for the most part, protected. The species is threatened by habitat loss and habitat degradation due to fire suppression, the difficulty of applying prescribed fire to pine rocklands, and exotic plants. Hydrology has been altered within Long Pine Key at Everglades National Park due to artificial drainage, which lowered ground water, and construction of roads, which either impounded or diverted water. Regional water management intended to restore the Everglades could negatively affect the pinelands of Long Pine Key, where the largest population occurs. At this time, it is not known whether Everglades restoration will have a positive or negative effect. This species may be vulnerable to catastrophic events and natural disturbances, such as hurricanes. Sea level rise will likely be a factor over the long term. After a thorough review of the species status and threats, the magnitude of threats continues to remain moderate to low, particularly since additional populations have recently been documented at Big Cypress National Preserve and on small pinelands in Miami-Dade County. We anticipate that additional occurrences will be found at Everglades National Park. Overall, the threats are nonimminent, particularly since most of the habitat is protected and managed to benefit this species. For the largest population in Everglades National Park, efforts are under way to ameliorate the threats from exotic plants. Therefore, we changed the LPN from a 9 to a 12 for this subspecies. *Solanum nelsonii* (Popolo)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Solanum nelsonii is a sprawling or trailing shrub found in coral rubble or sand in coastal sites. This species is known from populations in the northwestern Hawaiian Islands: Midway (approximately 260 plants), Laysan (approximately 490 plants), Pearl and Hermes (unknown number of individuals), Nihoa (8,000 to 15,000 adult plants); and Molokai (approximately 300 plants), in the main Hawaiian Islands. *Solanum nelsonii* is moderately threatened by ungulates (on Molokai) that degrade and destroy habitat, and that may eat it, and by nonnative plants that outcompete and displace it (Molokai and the northwestern Hawaiian Islands). Ungulate exclusion fences, routine fence monitoring and maintenance, and weed control protect the population of S. nelsonii on Molokai. Limited weed control is conducted in the northwestern Hawaiian Islands. In addition, *S. nelsonii* is likely threatened by being eaten by a nonnative grasshopper, *Schistocerca nitens,* in the northwestern Hawaiian Islands. Currently no control measures are in place for this grasshopper. Because these threats are of moderate magnitude and are imminent for the majority of the populations, we changed the LPN from a 2 to an 8. *Symphyotrichum georgianum* (Georgia aster)—Georgia aster is a relict species of post oak savanna/prairie communities that existed in the southeast prior to widespread fire suppression and extirpation of large native grazing animals. Most remaining populations survive adjacent to roads, utility rights of way and other openings where current land management mimics natural disturbance regimes. Georgia aster currently is known to occur in the States of Alabama, Georgia, North Carolina, and South Carolina. The species appears to have been extirpated from Florida. Most of the known populations are small (fewer than 50 stems), and because the species' main mode of reproduction is vegetative, each isolated population may represent only a few genotypes. A key factor impacting the Georgia aster is the present and threatened destruction, modification, and curtailment of its habitat and range as a result of subdivision development, highway expansion/improvement activities, herbicide application, and succession by wood plants due to fire suppression. The inadequacy of existing regulatory mechanisms is another factor posing a threat to the species, as approximately 95 percent of the known surviving populations are estimated to occur on private lands and no state or local laws protect the plants or their habitat. The species is not afforded specific protection on federal lands, where we estimate 5 percent of the populations occur. A third factor impacting the species is direct damage from mowing or herbicide applications conducted as part of maintenance along highways and rights of way; these activities can kill plants, and possibly extirpate populations in local areas. In previous years, we assigned an LPN of 5 to the Georgia aster, corresponding to a magnitude rating of high and an immediacy rating of nonimminent. However, based on the Service's efforts to achieve greater consistency in the interpretation of magnitude and immediacy, as well as new information regarding the abundance of the species, we are now revising the LPN. With regard to immediacy, the threats described above are currently occurring and are, therefore, imminent. We expect the threats are operating throughout the range of the species. However, the species is still relatively widely distributed, with occurrences in 3 counties in Alabama, 9 counties in North Carolina, 11 counties in South Carolina, and possibly as many as 18 counties in Georgia. Also, recent information indicates the species is more abundant than when we initially identified it as a candidate for listing, with possibly as many as 120 populations, in comparison to approximately 60 when it became a candidate in 1999. Taking into account its distribution and the new information indicating the species is more abundant than previously realized, we have revised the magnitude of threats from “high” to “moderate.” Therefore, we have changed the LPN from a 5 to an 8. Ferns and Allies *Christella boydiae* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is a small-to-medium-sized fern found in mesic to wet forest along streambanks on Oahu and Maui, Hawaii. Historically, this species was also found on the island of Hawaii; however, the species has been extirpated from that island. Currently, this species is known from 4 populations totaling fewer than 200 individuals. Two populations, numbering 162 and 2 individuals respectively, are found within Haleakala National Park on the island of Maui, where they are fenced and managed. The other two populations, numbering 5 and 9 individuals respectively, are located on State and private lands in the Koolau Mountains of Oahu. This species is threatened by feral pigs that degrade and/or destroy habitat and that may eat this plant, nonnative plants that compete for light and nutrients, and man-made stream diversion. Feral pigs have been fenced out of the two populations on Maui, and nonnative plants have been reduced in the fenced areas. No conservation efforts are under way to alleviate threats to the two populations on Oahu. The two managed populations constitute 92 percent of the currently known populations. Therefore, the magnitude of the threats acting upon the currently extant populations is considered moderate, while the threats from feral pig activities and nonnative plants are ongoing, and therefore imminent. Thus, we changed the LPN from a 2 to an 8 for this species. Taxonomic Changes in Candidates Mammals Mazama pocket gopher ( *Thomomys mazama* ssp. c *ouchi, douglasii, glacialis, louiei, melanops, pugetensis, tacomensis, tumuli, yelmensis* )—Based on mitochondrial DNA analysis, we are including an additional subspecies of Mazama pocket gopher (Brush Prairie pocket gopher, *T. Mazama douglasii)* , in our candidate list. See summary below under “ *Findings for Petitioned Candidate Species* ” for additional information. Insects Coral Pink Sand Dunes tiger beetle (Cicindela albissima)—Based on recently genetic research, this taxon was recently elevated to a full species. See summary above under “ *Summary of Listing Priority Changes in Candidates* ” for additional information. Candidate Removals As summarized below, we have evaluated the threats to the following four species and considered factors that, individually and in combination, presently or potentially could pose a risk to these species and their habitat. After a review of the best available scientific and commercial data, we conclude that listing these four species under the Endangered Species Act is not warranted because the species are not likely to become endangered species within the foreseeable future throughout all or a significant portion of their range. Therefore, for each of these species we find that proposing a rule to list them is not warranted, and we no longer consider them to be candidate species for listing. We will continue to monitor the status of these species, and to accept additional information and comments concerning this finding. We will reconsider this determination in the event that new information indicates that the threats to these species are of a considerably greater magnitude or imminence than identified through assessments of information in our files, as summarized here. The summary below also notes two other species for which we published separate findings removing them from candidate status since the most recent CNOR. Fish Fluvial arctic grayling, upper Missouri River DPS ( *Thymallus arcticus* )—see **Federal Register** notice published on April 24, 2007 (72 FR 20305). Insects Beaver Cave beetle ( *Pseudanophthalmus major* )—see **Federal Register** notice published on October 11, 2006 (71 FR 59711). Surprising cave beetle ( *Pseudanophthalmus inexpectatus Barr* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The surprising cave beetle is a small (4 mm), eyeless, reddish-brown, troglobitic insect that belongs to the ground beetle family Carabidae. The species is predatory, feeding upon other small cave invertebrates such as spiders, mites, and millipedes. We made the surprising cave beetle a candidate for listing on October 30, 2001. The species was originally described from two caves in Mammoth Cave National Park (MCNP), Kentucky—the historic entrance of Mammoth Cave (or Crevice Pit) and White Cave. Subsequent to this discovery, it was later found in Great Onyx Cave in MCNP. Since 2001, when we identified it as a candidate, we have found that the surprising cave beetle is more common and widespread than previously believed. In 2002, the species was discovered in a previously unnamed cave (now called Surprising Cave) within MCNP. This discovery was notable because it represented a northern range extension for the species and was made in a cave system that many speculate is completely separate from those located south of the Green River. In 2006, the species was discovered in a fifth cave (Saucer Cave) within MCNP. Thus, we now know that the distribution of the species includes at least five areas within MCNP. In addition, over the past 6 years a total of 10 individuals have been observed during routine surveys for other cave biota. Because the surprising cave beetle is small, cryptic, and difficult to locate within the cave environment, the collection of 10 individuals is a significant accomplishment for a *Pseudanophthalmus* survey, especially when the surprising cave beetle was not the target organism. Many of the caves in MCNP have not been adequately surveyed for *Pseudanophthalmus* or other small cave organisms, and based on the information now available, we believe the species is more common within these habitats than first believed. The most significant potential threats to the species (trampling by humans, habitat disturbance, and disruption of energy inputs) are abated by its location within a national park

(MCNP)and MCNP's strict control over the majority of the cave system and its habitats. Tours are offered in only two of the five caves where the species is known to occur, and tours take place in areas away from known beetle habitats. Habitat disturbance, vandalism, and entrance manipulation are unlikely to occur because the caves are in isolated, protected locations within a national park. Other potential threats, such as contamination of cave systems through polluted stormwater runoff and toxic chemical spills, are not considered to be significant because of their low probability of occurrence. In addition, we entered into a 15-year Candidate Conservation Agreement

(CCA)for the surprising cave beetle in 2001 with the National Park Service

(NPS)at MCNP. The purpose of this CCA is for the Service and NPS to jointly implement conservation measures for the surprising cave beetle in MCNP. Management activities undertaken by MCNP under the CCA increase protection and enhance the status of this species. The Agreement was updated in 2004, and the NPS continues their efforts under this agreement. Based on findings in our updated assessment of the surprising cave beetle, we conclude that listing this species under the Endangered Species Act is not warranted within the foreseeable future throughout all or a significant portion of its range. There is no portion of its range for which we have information that the species might be locally threatened. The current level of threats will not result in the species becoming in danger of extinction nor do we foresee threats increasing at any time in the future. The species no longer meets our definition of a candidate, and we have removed it from candidate status. Warm spring zaitzevian riffle beetle ( *Zaitzevia thermae* )—The warm spring zaitzevian riffle beetle is an aquatic flightless beetle endemic to Bridger Creek Warm Springs near Bozeman, Montana. This spring is entirely on land managed by the Service's Fish Technology Center

(FTC)and is a water source for the FTC. The warm spring zaitzevian riffle beetle is not known to drift within a water system with any probability of survival and requires clean water and small rock substrate absent siltation. The beetles feed on small pieces of algae and diatoms that they scrape from the submerged rocks. The warm spring zaitzevian riffle beetle requires warm and flowing surface water with surface temperatures of 16 to 29°C (60 to 84°F). Water temperature is likely the most influential factor in the species' biology. The distribution of the species is described as colonies found within three main areas along 50 linear meters

(m)(164 linear feet (ft)) of Bridger Creek where a warm spring emerges at or near creek water surface level. A large cement water collection box built around the spring in the early 1900s provides protection to the riffle beetle's spring habitat and it is within this sheltered area where the majority of the warm spring zaitzevian riffle beetle population occurs. A 1994 management plan prepared by the Service for the beetle guided successful implementation of actions to ensure that warm water flow out of the collection box to external seep habitat was not hindered by debris, make necessary repairs, maintain barricades and signs to prevent public disturbance of the beetle's habitat, and monitor water flow and the species to determine if conservation measures should be modified. The 1994 management plan also provided for removal of silt from the bottom of the collection box, if necessary; however, there has been no need to implement silt removal. In 2001, the FTC acquired 40 acres of land adjacent to and uphill from the spring, which provided additional protection of the spring by preventing development and adverse land use on these lands. The area around the spring continues to be protected by a chain-link fence and signs erected by the FTC, limiting foot traffic in the area (the area historically was used for swimming) as required in the 1994 management plan. In 2002, with approval of entomologists from Montana State University

(MSU)per the 1994 management plan, the height of the collection box roof was raised an additional 0.6 m (2 ft) to decrease the chance of Bridger Creek runoff or flood water contaminating water in the collection box. The purpose of this project was to protect the FTC's water source from potential pathogens, silt, aquatic nuisance species, decreased water temperature, and harmful chemicals, which in turn protects the habitat of the beetle. The project also included alteration to the roof of the water collection box to improve light penetration into the box for the beetles. The actions implemented through this project continue to effectively provide beetle habitat. In July 2006, a new Conservation Agreement and Strategy

(CAS)was finalized. The goal of the CAS is to ensure long-term, effective conservation of the warm spring zaitzevian riffle beetle and Brown's riffle beetle ( *Microcylloepus browni* ), another endemic beetle found in warm water seeps downstream of warm spring zaitzevian riffle beetle habitat. The CAS formalizes the ongoing cooperative effort of the signatories in conserving the warm spring zaitzevian riffle beetle in its native habitat. The signatories to the CAS are: the Service; Montana Fish, Wildlife and Parks; and MSU. Activities under the CAS are overseen by a workgroup of biologists representing the signatories. Under the 2006 CAS, water monitoring now is conducted by the Service according to the more detailed protocols in the CAS monitoring plan, which further ensures that necessary information will be acquired in order to respond appropriately in the event that water pollution or contamination is detected. Most of the conservation efforts described in the CAS are continuations of practices that were already being implemented, and are effective in addressing the potential threats to the warm spring zaitzevian riffle beetle. These efforts include continuing to remove debris from the cement box, maintenance of signage and delivery of educational materials, and review of any proposed changes in land and stream uses that might impact the species and its habitat. We carefully assessed the best scientific and commercial information available regarding the past, present, and future threats faced by the warm spring zaitzevian riffle beetle (habitat development or other alterations that would alter water flow, temperature or chemistry, and stochastic events such as flooding) and considered factors that, individually and in combination, could pose a risk to the species and its habitat. This species occurs in a single spring, and the area it occupies encompasses approximately 35 m 2 (377 ft 2 ), plus small adjacent seeps upstream and downstream where the species occurs in small numbers (approximately 1 m 2 (11 ft 2 ) of habitat). All occupied habitat is significant to the species due to its relatively small area and single location, therefore separate analysis of portions of the range is not applicable to this species. The foreseeable future for this species is linked to threats (habitat sustainability) more strongly than to life cycle timeframes; because the known population is carefully managed through the 2006 Conservation Agreement and Strategy, threats are not expected to increase within the foreseeable future. The FTC has committed to fund the CAS for 5 years, and we have no reason to believe that the FTC will discontinue funding and implementing the CAS into the future. We conclude that listing this species under the Act is not warranted. Because the current population is stable and threats have been addressed, it is not likely to become in danger of extinction within the foreseeable future throughout all or a significant portion of its range. This species no longer meets our definition of a candidate and is removed from candidate status. Flowering Plants *Erigeron basalticus* (Basalt daisy)— *Erigeron basalticus* is a perennial, herbaceous plant with a taproot and one to several sprawling stems 10 to 15 centimeters

(cm)(4 to 6 inches (in)) long. *Erigeron basalticus* grows in crevices in basalt cliffs on canyon walls, at elevations from 380 to 460 m (1,250 to 1,500 ft), along the Yakima River Canyon and Selah Creek, a tributary of the Yakima River, Washington. It is found in microsites that are largely devoid of other vegetation and undergoing primary succession. To date, threats from highway maintenance, rock quarrying, collection, location on private lands, herbicide spray drift, recreational rock climbing, or landslides previously described for this species have not been observed to affect numbers, distribution, or recruitment of *Erigeron basalticus* since the time it was initially surveyed. Overall population numbers have fluctuated within a range, but appear to be relatively stable since 1988. Monitoring of the majority of the known sites in June 2007, by the University of Washington College of Forest Resources, Botanic Gardens Rare Plant Care and Conservation Branch, provided additional data to support the removal of this species from candidacy. In addition to robust numbers counted in nearly all populations, the survey group discovered two previously unknown locations for *E. basalticus* so the species is more abundant than previously realized. The Bureau of Land Management has no plans to change management on the Areas of Critical Environmental Concern where several subpopulations of *E. basalticus* occur. Activities previously thought to pose potential threats to the species have not materialized and we have no basis for concluding that they would affect the species in the future. Continued surveys indicate subpopulations have been fluctuating in size within a reasonable range over time, and we have no reason to believe that this will change in the future. Further, there is no portion of its range for which we have information that the species might be locally threatened. Based on our updated assessment, we conclude that *E. basalticus* is not likely to become in danger of extinction within the foreseeable future throughout all or a significant portion of its range. Therefore we find that listing *E. basalticus* is not warranted and we remove this species from candidate status. Ferns and Allies *Botrychium lineare* (slender moonwort)—A member of the adder's-tongue family (Ophioglossaceae), *Botrychium lineare* is a small perennial fern. The species is known from 22 sites spread across 8 States (Alaska, Colorado, Minnesota, Montana, Oregon, South Dakota, Washington, and Wyoming) and two Canadian Provinces (Alberta and Yukon Territory), with a total geographic range of more than 107,000 square miles. Over 3,300 miles (5,300 kilometers) separate *B. lineare* sites in Alaska and Minnesota. Seventeen of the 20 known sites in the United States occur on Federal lands, with 3 sites found on private lands. Review of recent information indicates there is an increase in the number of known locations of *Botrychium lineare* and the geographic range is much larger than we previously understood. Based on increased survey efforts, at least 12 new population sites have been found in 6 states, including 4 new States, and two Canadian provinces since 2003. Population sites are generally small in area and number of individuals, making the species difficult to locate and survey for, or detect in plant surveys. Because *Botrychium* species have few diagnostic features (they are small and have only one leaf), *B. lineare* can be difficult to distinguish from other closely related moonworts. For example, one former *B. lineare* population site in Idaho and two in Nevada described in the May 11, 2005, Candidate Notice of Review (70 FR 24870) are now considered something other than *B. lineare* based on genetic analysis. Some researchers consider *B. lineare* a habitat generalist that may be an opportunistic colonizer since it is found in a variety of natural sites, and several extant population sites are found in man-made disturbed sites (i.e., roadsides and roadbeds, mine tailings, and along stream banks). Because they are found in a variety of habitat types, describing suitable or a specific habitat type is problematic. We believe that the species is more widespread than currently reported. The disjunct nature of known population sites over a wide geographic range of more than 107,000 square miles suggests that additional undetected *B. lineare* populations will likely be discovered both within and outside of the largely unsurveyed geographic range of the species in the United States and Canada. Much of the information provided to us regarding potential threats to *Botrychium lineare* is general in nature or there is uncertainty and very little documentation on how potential threats are affecting existing, disjunct populations, individual plants or the various natural and disturbed habitats of the species. Not all known population sites are exposed to potential threats. Where Federal land managers have recognized that threats could be affecting *B. lineare* populations, various conservation measures are being implemented. In total, potential threats are being addressed at 8 of the 20 *B. lineare* population sites in the United States (2 Canadian population sites not included). Invasive, nonnative species are reported to occur within 4 populations and adjacent to 10 populations. Conservation measures to reduce the occurrence of invasive species are under way at seven sites in Colorado, Montana, and Oregon. Monitoring to detect presence of additional invasive species is currently conducted at two additional sites in Oregon. Thirteen populations occur adjacent to or near roads; avoidance and minimization measures are in place at four sites in Colorado and one site in South Dakota to reduce the impact of road-related activities. Livestock impacts have been precluded at one site in Washington through an exclosure. Based on our updated assessment, we have determined that *Botrychium lineare* is not likely to become in danger of extinction within the foreseeable future throughout all or a significant portion of its range. We have no information that indicates that any of the known *B. lineare* populations constitute a significant portion of the range of the species or that there is any portion of its range where the species might be locally threatened. *Botrychium lineare's* known geographic range is much larger than previously understood and it is likely that additional *B. lineare* populations will be discovered both within and outside of the largely unsurveyed geographic range of the species in the United States and Canada. There is also insufficient information to adequately describe suitable habitat for the species, or to fully understand *B. lineare's* biological vulnerability to potential threat factors. Therefore, we find that listing is not warranted and we remove this species from candidate status. Petition Findings The Act provides two mechanisms for considering species for listing. One method allows the Secretary, on his own initiative, to identify species for listing under the standards of section 4(a)(1). We implement this through the candidate program, discussed above. The second method for listing a species provides a mechanism for the public to petition us to add a species to the Lists. Under section 4(b)(3)(A), when we receive such a petition, we must determine within 90 days, to the maximum extent practicable, whether the petition presents substantial information that listing may be warranted (a “90-day finding”). If we make a positive 90-day finding, we must promptly commence a status review of the species under section 4(b)(3)(A); we must then make and publish one of three possible findings within 12 months of the receipt of the petition (a “12-month finding”): 1. The petitioned action is not warranted; 2. The petitioned action is warranted (in which case we are required to promptly publish a proposed regulation to implement the petitioned action; once we publish a proposed rule for a species, section 4(b)(5) and 4(b)(6) govern further procedures regardless of whether we issued the proposal in response to a petition); or 3. The petitioned action is warranted but

(a)the immediate proposal of a regulation and final promulgation of regulation implementing the petitioned action is precluded by pending proposals, and

(b)expeditious progress is being made to add qualified species to the lists of endangered or threatened species. (We refer to this as a “warranted-but-precluded finding.”) Section 4(b)(3)(C) of the Act requires that when we make a warranted but precluded finding on a petition, we are to treat such a petition as one that is resubmitted on the date of such a finding. Thus, we are required to publish new 12-month findings on these “resubmitted” petitions on an annual basis. On December 5, 1996, we made a final decision to redefine “candidate species” to mean those species for which the Service has on file sufficient information on biological vulnerability and threat(s) to support issuance of a proposed rule to list, but for which issuance of the proposed rule is precluded (61 FR 64481; December 6, 1996). Therefore, the standard for making a species a candidate through our own initiative is identical to the standard for making a warranted-but-precluded 12-month petition finding on a petition to list, and we add all petitioned species for which we have made a warranted-but-precluded 12-month finding to the candidate list. This publication also provides notice of substantial 90-day findings and the warranted-but-precluded 12-month findings pursuant to section 4(b)(3) for candidate species listed on Table 1 that we identified on our own initiative, and that subsequently have been the subject of a petition to list. Even though all candidate species identified through our own initiative already have received the equivalent of substantial 90-day and warranted-but-precluded 12-month findings, we reviewed the status of the newly petitioned candidate species and through this CNOR are publishing specific section 4(b)(3) findings (i.e., substantial 90-day and warranted but precluded 12-month findings) in response to the petitions to list these candidate species. We publish these findings as part of the first CNOR following receipt of the petition. Pursuant to section 4(b)(3)(C)(i) of the Act, once a petition is filed regarding a candidate species, we must make a 12-month petition finding in compliance with section 4(b)(3)(B) of the Act at least once a year, until we publish a proposal to list the species or make a final not-warranted finding. We make this annual finding for petitioned candidate species through the CNOR. Section 4(b)(3)(C)(iii) of the Act requires us to “implement a system to monitor effectively the status of all species” for which we have made a warranted-but-precluded 12-month finding, and to “make prompt use of the [emergency listing] authority [under section 4(b)(7)] to prevent a significant risk to the well being of any such species.” The CNOR plays a crucial role in the monitoring system that we have implemented for all candidate species by providing notice that we are actively seeking information regarding the status of those species. We review all new information on candidate species as it becomes available, prepare an annual species assessment form that reflects monitoring results and other new information, and identify any species for which emergency listing may be appropriate. If we determine that emergency listing is appropriate for any candidate, whether it was identified through our own initiative or through the petition process, we will make prompt use of the emergency listing authority under section 4(b)(7). We have been reviewing and will continue to review, at least annually, the status of every candidate, whether or not we have received a petition to list it. Thus, the CNOR and accompanying species assessment forms also constitute the Service's annual finding on the status of petitioned species pursuant to section 4(b)(3)(C)(i). On June 20, 2001, the United States Court of Appeals for the Ninth Circuit held that the 1999 CNOR (64 FR 57534; October 25, 1999) did not demonstrate that we fulfilled the second component of the warranted-but-precluded 12-month petition findings for the Gila chub and Chiracahua leopard frog ( *Center for Biological Diversity* v. *Norton,* 254 F.3d 833 (9th Cir. 2001)). The court found that the one-line designation in the table of candidates in the 1999 CNOR, with no further explanation, did not satisfy section 4(b)(3)(B)(iii)'s requirement that the Service publish a finding “together with a description and evaluation of the reasons and data on which the finding is based.” The court suggested that this one-line statement of candidate status also precluded meaningful judicial review. On June 21, 2004, the United States District Court for Oregon agreed that we can use the CNOR as a vehicle for making petition findings and that our reasoning for why listing is precluded does not need to be based on an assessment at a regional level (as opposed to a national level) ( *Center for Biological Diversity* v. *Norton* Civ. No. 03-1111-AA (D. Or.)). However, this court found that our discussion on why listing the candidate species were precluded by other actions lacked specificity; in the list of species that were the subject of listing actions that precluded us from proposing to list candidate species, we did not state the specific action at issue for each species in the list and we did not indicate which actions were court-ordered. On June 22, 2004, in a similar case, the United States District Court for the Eastern District of California also concluded that our determination of preclusion may appropriately be based on a national analysis ( *Center for Biological Diversity* v. *Norton* No. CV S-03-1758 GEB/DAD (E.D. Cal.)). This court also found that the Act's imperative that listing decisions be based solely on science applies only to the determination about whether listing is warranted, not the question of when listing is precluded. On March 24, 2005, the United States District Court for the District of Columbia held that we may not consider critical habitat activities in justifying our inability to list candidate species, requiring that we justify both our preclusion findings and our demonstration of expeditious progress by reference to listing proceedings for unlisted species ( *California Native Plant Society* v. *Norton* , Civ. No. 03-1540

(JR)(D.D.C.)). The court further found that we must adequately itemize priority listings, explain why certain species are of high priority, and explain why actions on these high-priority species preclude listing species of lower priority. The court approved our reliance on national rather than regional priorities and workload in establishing preclusion and approved our basic explanation that listing candidate species may be precluded by statutorily mandated deadlines, court-ordered actions, higher-priority listing activities, and a limited budget. We drafted previous CNORs to address the concerns of these courts and continue to incorporate those changes that addressed the courts' concerns in this CNOR. We include a description of the reasons why the listing of every petitioned candidate species is both warranted and precluded at this time. We make our determinations of preclusion on a nationwide basis to ensure that the species most in need of listing will be addressed first and also because we allocate our listing budget on a nationwide basis (see below). Regional priorities can also be discerned from Table 1, which includes the lead region and the LPN for each species. Our preclusion determinations are further based upon our budget for listing activities for unlisted species and we explain the priority system and why the work we have accomplished does preclude action on listing candidate species. Pursuant to section 4(b)(3)(C)(ii) and the Administrative Procedure Act (5 U.S.C. 551 et seq.), any party with standing may challenge the merits of any not-warranted or warranted-but-precluded petition finding incorporated in this CNOR. The analysis included herein, together with the administrative record for the decision at issue (particularly the supporting species assessment form), will provide an adequate basis for a court to review the petition finding. Nothing in this document or any of our policies should be construed as in any way modifying the Act's requirement that we make a resubmitted 12-month petition finding for each petitioned candidate within 1 year of the date of publication of this CNOR. If we fail to make any such finding on a timely basis, whether through publication of a new CNOR or some other form of notice, any party with standing may seek judicial review. In this CNOR, we continue to address the concerns of the courts by including more specific information in our discussion on preclusion (see below). In preparing this CNOR, we reviewed the current status of and threats to the 203 candidates and 5 listed species for which we have received a petition and for which we have found listing or reclassification from threatened to endangered to be warranted but precluded. We find that the immediate issuance of a proposed rule and timely promulgation of a final rule for each of these species has been, for the preceding months, and continues to be, precluded by higher-priority listing actions. Additional information that is the basis for this finding is found in the species assessments and our administrative record for each species. Our review included updating the status of and threats to petitioned candidate or listed species for which we published findings, pursuant to section 4(b)(3)(B), in the previous CNOR. We have incorporated new information we gathered since the prior finding and, as a result of this review, we are making continued warranted-but-precluded 12-month findings on the petitions for these species. We have identified the candidate species for which we received petitions by the code “C*” in the category column on the left side of Table 1. As discussed above, the immediate publication of proposed rules to list these species was precluded by our work on higher-priority listing actions, listed below, during the period from September 12, 2006, through September 30, 2007. We will continue to monitor the status of all candidate species, including petitioned species, as new information becomes available. This review will determine if a change in status is warranted, including the need to emergency-list a species under section 4(b)(7) of the Act. In addition to identifying petitioned candidate species in Table 1 below, we also present brief summaries of why these particular candidates warrant listing. More complete information, including references, is found in the species assessment forms. You may obtain a copy of these forms from the Regional Office having the lead for the species, or from the Fish and Wildlife Service's Internet Web site: *http://endangered.fws.gov/* . As described above, under section 4 of the Act we may identify and propose species for listing based on the factors identified in section 4(a)(1), and section 4 also provides a mechanism for the public to petition us to add a species to the lists of species determined to be threatened species or endangered species under the Act. Below we describe the actions that continue to preclude the immediate proposal of a regulation and final promulgation of a regulation implementing the petitioned action, and we describe the expeditious progress we are making to add qualified species to the lists of endangered or threatened species. Preclusion and Expeditious Progress Preclusion is a function of the listing priority of a species in relation to the resources that are available and competing demands for those resources. (As described above in the Summary, the listing priority of a species is represented by the LPN we assign to it.) Thus, in any given fiscal year (FY), multiple factors dictate whether it will be possible to undertake work on a proposed listing regulation or whether promulgation of such a proposal is warranted but precluded by higher-priority listing actions. The resources available for listing actions are determined through the annual Congressional appropriations process. The appropriation for the Listing Program is available to support work involving the following listing actions: Proposed and final listing rules; 90-day and 12-month findings on petitions to add species to the Lists or to change the status of a species from threatened to endangered; resubmitted petition findings; proposed and final rules designating critical habitat; and litigation-related, administrative, and program management functions (including preparing and allocating budgets, responding to Congressional and public inquiries, and conducting public outreach regarding listing and critical habitat). The work involved in preparing various listing documents can be extensive and may include, but is not limited to: Gathering and assessing the best scientific and commercial data available and conducting analyses used as the basis for our decisions; writing and publishing documents; and obtaining, reviewing, and evaluating public comments and peer review comments on proposed rules and incorporating relevant information into final rules. The number of listing actions that we can undertake in a given year also is influenced by the complexity of those listing actions; that is, more complex actions generally are more costly. For example, during the past several years, the cost (excluding publication costs) for preparing a 12-month finding, without a proposed rule, has ranged from approximately $11,000 for one species with a restricted range and involving a relatively uncomplicated analysis to $305,000 for another species that is wide-ranging and involving a complex analysis. We cannot spend more than is appropriated for the Listing Program without violating the Anti-Deficiency Act (see 31 U.S.C. 1341(a)(1)(A)). In addition, in FY 1998 and for each fiscal year since then, Congress has placed a statutory cap on funds which may be expended for the Listing Program, equal to the amount expressly appropriated for that purpose in that fiscal year. This cap was designed to prevent funds appropriated for other functions under the Act (e.g., Recovery funds for removing species from the Lists), or for other Service programs, from being used for Listing Program actions (see House Report 105-163, 105th Congress, 1st Session, July 1, 1997). Recognizing that designation of critical habitat for species already listed would consume most of the overall Listing Program appropriation, Congress also put a critical habitat subcap in place in FY 2002 and has retained it each subsequent year to ensure that some funds are available for other work in the Listing Program: “The critical habitat designation subcap will ensure that some funding is available to address other listing activities” (House Report No. 107-103, 107th Congress, 1st Session, June 19, 2001). In FY 2002 and each year until last year (FY 2006), the Service has had to use virtually the entire critical habitat subcap to address court-mandated designations of critical habitat, and consequently none of the critical habitat subcap funds have been available for other listing activities. Thus, through the listing cap, the critical habitat subcap, and the amount of funds needed to address court-mandated critical habitat designations, Congress and the courts have in effect determined the amount of money available for other listing activities. Therefore, the funds in the listing cap, other than those needed to address court-mandated critical habitat for already listed species, set the limits on our determinations of preclusion and expeditious progress. Congress also recognized that the availability of resources was the key element in deciding whether, when making a 12-month petition finding, we would prepare and issue a listing proposal or make a “warranted but precluded” finding for a given species. The Conference Report accompanying Pub. L. 97-304, which established the current statutory deadlines and the warranted-but-precluded finding, states (in a discussion on 90-day petition findings that by its own terms also covers 12-month findings) that the deadlines were “not intended to allow the Secretary to delay commencing the rulemaking process for any reason other than that the existence of pending or imminent proposals to list species subject to a greater degree of threat would make allocation of resources to such a petition [i.e., for a lower-ranking species] unwise.” Taking into account the information presented above, in FY 2007, the outer parameter within which “expeditious progress” must be measured is that amount of progress that could be achieved by spending $5,193,000, which was the amount available in the Listing Program appropriation that was not within the critical habitat subcap. Our process is to make our determinations of preclusion on a nationwide basis to ensure that the species most in need of listing will be addressed first and also because we allocate our listing budget on a nationwide basis. However, through court orders and court-approved settlements, Federal district courts have mandated that we must complete certain listing activities with respect to specified species and have established the schedules by which we must complete those activities. The species involved in these court-mandated listing activities are not always those that we have identified as being most in need of listing. As described below, a majority of the $5,193,000 appropriation available in FY 2007 for new listings of species is being consumed by court-mandated listing activities; by ordering or sanctioning these actions, the courts essentially determined that these were the highest priority actions to be undertaken with available funding. Copies of the court orders and settlement agreements referred to below are available from the Service and are part of the administrative record for these resubmitted petition findings. The FY 2007 appropriation of $5,193,000 for listing activities (that is, the portion of the Listing Program funding not related to critical habitat designations for species that already are listed) was fully allocated to fund work in the following categories of actions in the Listing Program: Compliance with court orders and court-approved settlement agreements requiring that petition findings or listing determinations be completed by a specific date; section 4 (of the Act) listing actions with absolute statutory deadlines; essential litigation-related, administrative, and program management functions; and a few high-priority listing actions. The allocations for each specific listing action were identified in the Service's FY 2007 Allocation Table (part of our administrative record). Although more funds were available in FY 2007 than in previous years to work on listing actions that were not the subject of court orders or court-approved settlement agreements, based on the available funds and their allocation for these purposes, only limited FY 2007 funds were available for work on proposed listing determinations for the following high-priority candidate species: 3 southeastern aquatic species, all with LPN 2 (Georgia pigtoe, interrupted rocksnail, and rough hornsnail); 2 species from the island of Oahu, Hawaii, both with LPN 2 ( *Doryopteris takeuchii* and *Melicope hiiakae* ); 1 species from the island of Molokai, Hawaii, with LPN 2 ( *Phyllostegia hispida* ); 31 species from the island of Kauai, Hawaii, including 24 species with LPN 2 and 7 other candidates included in the listing determination package for the sake of efficiency because they overlap geographically and/or have the same threats (Kauai creeper, *Drosophila attigua, Astelia waialealae, Canavalia napaliensis, Chamaesyce eleanoriae, Chamaesyce remyi* var. *kauaiensis, Chamaesyce remyi* var. *remyi, Charpentiera densiflora, Cyanea eleeleensis, Cyanea kuhihewa, Cyrtandra oenobarba, Dubautia imbricata* ssp. *imbricata, Dubautia plantaginea* ssp. *magnifolia, Dubautia waialealae, Geranium kauaiense, Keysseria erici, Keysseria helenae, Labordia helleri, Labordia pumila, Lysimachia daphnoides, Melicope degeneri, Melicope paniculata, Melicope puberula, Myrsine mezii, Pittosporum napaliense, Platydesma rostrata, Pritchardia hardyi, Psychotria grandiflora, Psychotria hobdyi, Schiedea attenuata, Stenogyne kealiae* ); and 4 Hawaiian damselflies, all with LPN 2 ( *Megalagrion nesiotes, Megalagrion leptodemas, Megalagrion oceanicum, Megalagrion pacificum* ). FY 2007 listing allocation Allocated Available balance FY07 Appropriation (including space reprogramming) $5,193,000 $5,193,000 Space reprogramming (program's portion of rent for building space) 216,778 4,976,222 Regional & Washington Offices (staff salaries & benefits and administrative costs) 1,674,012 3,302,210 90-day findings 604,617 2,697,593 12-month findings 830,193 1,867,400 Proposed Listing/Critical Habitat 963,000 904,400 Economic Analysis (for Critical Habitat) 504,400 400,000 Final Listing/CH 300,000 100,000 Attorney Fees/Litigation Expenses 100,000 0 Specific details regarding the individual actions taken using the FY 2007 funding, which precluded our ability to undertake listing proposals for candidate species, except the species noted above, are provided below (information on the cost of individual actions is part of our administrative record). In addition to being precluded by lack of available funds, work on proposed rules for candidates with lower priority (i.e., those that have LPNs of 4-12) is also precluded by the need to issue proposed rules for higher-priority species facing high-magnitude, imminent threats (i.e., LPNs of 1-3). We currently have more than 120 species with an LPN of 2 (see Table 1). We further ranked the candidate species with an LPN of 2 by using the following extinction-risk type criteria: IUCN Red list status/rank, Heritage rank (provided by NatureServe), Heritage threat rank (provided by NatureServe), and species currently with fewer than 50 individuals, or 4 or fewer populations. Those species with the highest IUCN rank (critically endangered), the highest Heritage rank (G1), the highest Heritage threat rank (substantial, imminent threats), and currently with fewer than 50 individuals, or fewer than 4 populations comprise a list of approximately 40 candidate species that have the highest priority to receive funding to work on a proposed listing determination. Note, to be more efficient in our listing process, as we work on proposed rules for these species in the next several years, we are preparing multi-species proposals when appropriate, and these may include species with lower priority if they overlap geographically or have the same threats as species with LPN of 2. Finally, proposed rules for reclassification of threatened species to endangered are lower priority, since the listing of the species already affords the protection of the Act and implementing regulations. Thus, we continue to find that proposals to list the petitioned candidate species included in Table 1 are all warranted but precluded, except for the candidate species listed above. As explained above, a determination that listing is warranted but precluded must also demonstrate that expeditious progress is being made to add qualified species to, and remove qualified species from, the Lists. (We note that in this CNOR we do not discuss specific actions taken on progress towards removing species from the Lists because that work is conducted using appropriations for our Recovery program, a separately budgeted component of the Endangered Species Program. As explained above in our description of the statutory cap on Listing Program funds, the Recovery Program funds and actions supported by them cannot be considered in determining expeditious progress made in the Listing Program.) As with our “precluded” finding, expeditious progress in adding qualified species to the Lists is a function of the resources available and the competing demands for those funds. Our expeditious progress in FY 2007 in the Listing Program, through September 30, 2007, included preparing and publishing the following: FY 2007 Completed Listing Actions as of 09/30/2007 Publication date Title Actions FR pages 10/11/2006 Withdrawal of the Proposed Rule to List the Cow Head Tui Chub ( *Gila biocolor vaccaceps* ) as Endangered Notice of withdrawal, Threats eliminated 71 FR 59700-59711. 10/11/2006 Revised 12-Month Finding for the Beaver Cave Beetle ( *Pseudanophthalmus major* ) Notice of 12-month petition finding, Not warranted 71 FR 59711-59714. 11/14/2006 12-Month Finding on a Petition to List the Island Marble Butterfly ( *Euchloe ausonides insulanus* ) as Threatened or Endangered Notice of 12-month petition finding, Not warranted 71 FR 66292-66298. 11/14/2006 90-Day Finding for a Petition to List the Kennebec River Population of Anadromous Atlantic Salmon as Part of the Endangered Gulf Of Maine Distinct Population Segment Notice of 90-day petition finding, Substantial 71 FR 66298-66301. 11/21/2006 90-Day Finding on a Petition To List the Columbian Sharp-Tailed Grouse as Threatened or Endangered Notice of 90-day petition finding, Not substantial 71 FR 67318-67325. 12/5/2006 90-Day Finding on a Petition To List the Tricolored Blackbird as Threatened or Endangered Notice of 90-day petition finding, Not substantial 71 FR 70483-70492. 12/6/2006 12-Month Finding on a Petition To List the Cerulean Warbler ( *Dendroica cerulea* ) as Threatened with Critical Habitat Notice of 12-month petition finding, Not warranted 71 FR 70717-70733. 12/6/2006 90-Day Finding on a Petition To List the Upper Tidal Potomac River Population of the Northern Water Snake ( *Nerodia sipedon* ) as an Endangered Distinct Population Segment Notice of 90-day petition finding, Not substantial 71 FR 70715-70717. 12/14/2006 90-Day Finding on a Petition to Remove the Uinta Basin Hookless Cactus From the List of Endangered and Threatened Plants; 90-Day Finding on a Petition To List the Pariette Cactus as Threatened or Endangered Notice of 5-year Review, Initiation Notice of 90-day petition finding, Not substantial Notice of 90-day petition finding, Substantial 71 FR 75215-75220. 12/19/2006 Withdrawal of Proposed Rule to List *Penstemon grahamii* (Graham's beardtongue) as Threatened With Critical Habitat Notice of withdrawal, More abundant than believed, or diminished threats 71 FR 76023-76035. 12/19/2006 90-Day Finding on Petitions to List the Mono Basin Area Population of the Greater Sage-Grouse as Threatened or Endangered Notice of 90-day petition finding, Not substantial 71 FR 76057-76079. 1/9/2007 12-Month Petition Finding and Proposed Rule To List the Polar Bear ( *Ursus maritimus* ) as Threatened Throughout Its Range; Proposed Rule Notice of 12-month petition finding, Warranted Proposed Listing, Threatened 72 FR 1063-1099. 1/10/2007 Endangered and Threatened Wildlife and Plants; Clarification of Significant Portion of the Range for the Contiguous United States Distinct Population Segment of the Canada Lynx Clarification of findings 72 FR 1186-1189. 1/12/2007 Withdrawal of Proposed Rule To List *Lepidium papilliferum* (Slickspot Peppergrass) Notice of withdrawal, More abundant than believed, or diminished threats 72 FR 1621-1644. 2/2/2007 12-Month Finding on a Petition To List the American Eel as Threatened or Endangered Notice of 12-month petition finding, Not warranted 72 FR 4967-4997. 2/13/2007 90-Day Finding on a Petition To List the Jollyville Plateau Salamander as Endangered Notice of 90-day petition finding, Substantial 72 FR 6699-6703. 2/13/2007 90-Day Finding on a Petition To List the San Felipe Gambusia as Threatened or Endangered Notice of 90-day petition finding, Not substantial 72 FR 6703-6707. 2/14/2007 90-Day Finding on a Petition to List *Astragalus debequaeus* (DeBeque milkvetch) as Threatened or Endangered Notice of 90-day petition finding, Not substantial 72 FR 6998-7005. 2/21/2007 90-Day Finding on a Petition To Reclassify the Utah Prairie Dog From Threatened to Endangered and Initiation of a 5-Year Review Notice of 5-year Review, Initiation Notice of 90-day petition finding, Not substantial 72 FR 7843-7852. 3/8/2007 90-Day Finding on a Petition To List the Monongahela River Basin Population of the Longnose Sucker as Endangered Notice of 90-day petition finding, Not substantial 72 FR 10477-10480. 03/29/2007 90-Day Finding on a Petition To List the Siskiyou Mountains Salamander and Scott Bar Salamander as Threatened or Endangered Notice of 90-day petition finding, Substantial 72 FR 14750-14759. 04/24/2007 Revised 12-Month Finding for Upper Missouri River Distinct Population Segment of Fluvial Arctic Grayling Notice of 12-month petition finding, Not warranted 72 FR 20305-20314. 05/02/2007 12-Month Finding on a Petition to List the Sand Mountain Blue Butterfly ( *Euphilotes pallescens* ssp. *arenamontana* ) as Threatened or Endangered with Critical Habitat Notice of 12-month petition finding, Not warranted 72 FR 24253-24263. 05/22/2007 Status of the Rio Grande Cutthroat Trout Notice of Review 72 FR 28864-28665. 05/30/2007 90-Day Finding on a Petition To List the Mt. Charleston Blue Butterfly as Threatened or Endangered Notice of 90-day petition finding, Substantial 72 FR 29933-29941. 06/05/2007 12-Month Finding on a Petition To List the Wolverine as Threatened or Endangered Notice of Review 72 FR 31048-31049. 06/06/2007 90-Day Finding on a Petition To List the Yellow-Billed Loon as Threatened or Endangered Notice of 90-day petition finding, Substantial 72 FR 31256-31264. 06/13/2007 12-Month Finding for a Petition To List the Colorado River Cutthroat Trout as Threatened or Endangered Notice of 12-month petition finding, Not warranted 72 FR 32589-32605. 06/25/2007 12-Month Finding on a Petition To List the Sierra Nevada Distinct Population Segment of the Mountain Yellow-Legged Frog ( *Rana muscosa* ) Notice of amended 12-month petition finding, Warranted but Precluded 72 FR 34657-34661. 07/05/2007 12-Month Finding on a Petition To List the Casey's June Beetle ( *Dinacoma caseyi* ) as Endangered With Critical Habitat Notice of 12-month petition finding, Warranted but precluded 72 FR 36635-36646. 08/15/2007 90-Day Finding on a Petition To List the Yellowstone National Park Bison Herd as Endangered Notice of 90-day petition finding, Not substantial 72 FR 45717-45722. 08/16/2007 90-Day Finding on a Petition To List *Astragalus anserinus* (Goose Creek milk-vetch) as Threatened or Endangered Notice of 90-day petition finding, Substantial 72 FR 46023-46030. 8/28/2007 12-Month Finding on a Petition To List the Gunnison's Prairie Dog as Threatened or Endangered Notice of Review 72 FR 49245-49246. 9/11/2007 90-Day Finding on a Petition To List Kenk's Amphipod, Virginia Well Amphipod, and the Copepod Acanthocyclops columbiensis as Endangered Notice of 90-day petition finding, Not substantial 72 FR 51766-51770. 9/18/2007 12-Month Finding on a Petition To List *Sclerocactus brevispinus* (Pariette cactus) as an Endangered or Threatened Species; Taxonomic Change From Sclerocactus glaucus to Sclerocactus brevispinus, S. glaucus, and S. wetlandicus Notice of 12-month petition finding for uplisting, Warranted but precluded 72 FR 53211-53222. Our expeditious progress also includes work on listing actions for 68 species for which decisions were not completed as of the end of FY 2007. These actions are listed below; we are conducting work on those actions in the top section of the table under a deadline set by a court, actions in the middle section of the table to meet statutory timelines, that is, timelines required under the Act, and actions in the bottom section of the table are high priority listing actions: Listing Actions Funded but Not completed in FY2007 Species Action Actions Subject to Court Order/Settlement Agreement Wolverine 12-month petition finding (remand). Western sage grouse 90-day petition finding (remand). Queen Charlotte goshawk Final listing determination. Rio Grande cutthroat trout Candidate assessment (remand). Statutory Listing Actions Polar bear Final listing determination. Ozark chinquapin 90-day petition finding. Kokanee 90-day petition finding. Black-footed albatross 90-day petition finding. Tucson shovel-nosed snake 90-day petition finding. Gopher tortoise—Florida population 90-day petition finding. Sacramento valley tiger beetle 90-day petition finding. Eagle lake trout 90-day petition finding. Smooth billed ani 90-day petition finding. Mojave ground squirrel 90-day petition finding. Gopher tortoise—eastern population 90-day petition finding. Bay Springs salamander 90-day petition finding. Tehachapi slender salamander 90-day petition finding. Coaster brook trout 90-day petition finding. Mojave fringe-toed lizard 90-day petition finding. Evening primrose 90-day petition finding. Palm Springs pocket mouse 90-day petition finding. Northern leopard frog 90-day petition finding. Mountain whitefish—Big Lost River population 90-day petition finding. Giant Palouse earthworm 90-day petition finding. Shrike, Island loggerhead 90-day petition finding. Cactus ferruginous pygmy owl 90-day petition finding. High Priority Listing Actions 3 Southeastern aquatic species Proposed listing 2 Oahu plants Proposed listing 31 Kauai species Proposed listing 4 Hawaiian damselflies Proposed listing *Phyllostegia hispida* Proposed listing We also funded work on resubmitted petitions findings for 203 candidate species and 5 listed species (species petitioned prior to the last CNOR). Note we have not updated our resubmitted petition finding for the Columbia Basin population of the greater sage-grouse in this notice as we are considering new information and will update our findings at a later date. We also have not updated our resubmitted petition findings for the 41 candidate species for which we are preparing proposed listing determinations, which will be published at a later date (see summaries below). As explained above, these resubmitted petition findings are required by statute, and findings for these 203 candidates and 5 listed species are being published as part of this CNOR. We also funded revised 12-month petition findings for 4 candidate species that we are removing from candidate status, which are being published as part of this CNOR (see *Summary of Candidate Removals* ). We are also funding work on the next annual review of those resubmitted petition findings, which will be published as part of the next CNOR. Because the majority of these species were already candidate species prior to our receipt of a petition to list them, we had already assessed their status using funds from our Candidate Conservation Program. We also continue to monitor the status of these species through our Candidate Conservation Program. The cost of updating the species assessment forms and publishing the joint publication of the CNOR and resubmitted petition findings is shared between the Listing Program and the Candidate Conservation Program. We have endeavored to make our listing actions as efficient and timely as possible, given the requirements of the relevant law and regulations, and constraints relating to workload and personnel. We are continually considering ways to streamline processes or achieve economies of scale, such as by batching related actions together. Given our limited budget for implementing section 4 of the Act, these actions described above collectively constitute expeditious progress. Although we have not been able to resolve the listing status of many of the candidates, several programs in the Service contribute to the conservation of these species. In particular, we have a separate budgeted program, the Candidate Conservation program, which focuses on providing technical expertise for developing conservation strategies and agreements to guide voluntary on-the-ground conservation work for candidate and other at-risk species. The main goal of this program is to address the threats facing candidate species. If sufficiently successful, this eliminates the need to list them, allowing us to remove them from the candidate list. Through this program, we work with our partners (other Federal agencies, State agencies, Tribes, local governments, private landowners, and private conservation organizations) to address the threats to candidate species and other species at risk. We are actively engaged in the conservation of these species and have, to-date, signed more than 100 Candidate Conservation Agreements and 16 Candidate Conservation Agreements with Assurances. We are implementing these voluntary conservation agreements for more than 140 species covering 5 million acres of habitat. Through sustained implementation of strategically designed conservation efforts, we are actively working to conserve many candidate species. In some instances, this culminates in making listing unnecessary for species that are proposed or candidates for listing. Recent examples include the Cow Head tui chub, Beaver Cave beetle, Surprising Cave beetle, and Warm Spring zaitzevian riffle beetle. Findings for Petitioned Candidate Species For our revised 12-month petition findings for species we are removing from candidate status, see summaries above under *“Summary of Candidate Removals.”* Mammals Pacific Sheath-tailed Bat, American Samoa DPS ( *Emballonura semicaudata semicaudata* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This small bat is a member of the Emballonuridae, an Old World bat family that has an extensive distribution, primarily in the tropics. The Pacific sheath-tailed bat was once common and widespread in Polynesia and Micronesia and it is the only insectivorous bat recorded from a large part of this area. The species as a whole ( *E. semicaudata* ) occurred on several of the Caroline Islands (Palau, Chuuk, and Pohnpei), Samoa (Independent and American), the Mariana Islands (Guam and the CNMI), Tonga, Fiji, and Vanuatu. While populations appear to be healthy in some locations, mainly in the Caroline Islands, they have declined drastically in other areas, including Independent and American Samoa, the Mariana Islands, Fiji, and possibly Tonga. Scientists recognize four subspecies: *E. s. rotensis,* endemic to the Mariana Islands (Guam and the Commonwealth of the Northern Mariana Islands (CNMI)); *E. s. sulcata,* occurring in Chuuk and Pohnpei; *E. s. palauensis,* found in Palau; and *E. s. semicaudata,* occurring in American and Independent Samoa, Tonga, Fiji, and Vanuatu. This candidate assessment form addresses the distinct population segment of *E. s. semicaudata* that occurs in American Samoa. *E. s. semicaudata* historically occurred in American and Independent Samoa, Tonga, Fiji, and Vanuatu. It is extant in Fiji and Tonga, but may be extirpated from Vanuatu and Independent Samoa. There is some concern that it is also extirpated from American Samoa, where surveys are currently ongoing to ascertain its status. The factors that have led to the decline of this subspecies are poorly understood; however, current threats to this subspecies include habitat loss, predation by introduced species, and its small population size and distribution, which make the taxon extremely vulnerable to extinction due to typhoons and similar natural catastrophes. The Pacific sheath-tailed bat may also by susceptible to disturbance to roosting caves. The LPN for *E. s. semicaudata* is 3, because the magnitude of the threats is high, the threats are imminent, and the taxon in question is a distinct population segment of a subspecies. Pacific Sheath-tailed Bat ( *Emballonura semicaudata rotensis* ), Guam and the Commonwealth of the Northern Mariana Islands—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This small bat is a member of the Emballonuridae, an Old World bat family that has an extensive distribution, primarily in the tropics. The Pacific sheath-tailed bat was once common and widespread in Polynesia and Micronesia and it is the only insectivorous bat recorded from a large part of this area. The species as a whole ( *E. semicaudata* ) occurred on several of the Caroline Islands (Palau, Chuuk, and Pohnpei), Samoa (Independent and American), the Mariana Islands (Guam and the CNMI), Tonga, Fiji, and Vanuatu. While populations appear to be healthy in some locations, mainly in the Caroline Islands, they have declined drastically in other areas, including Independent and American Samoa, the Mariana Islands, Fiji, and possibly Tonga. Scientists recognize four subspecies: *E. s. rotensis,* endemic to the Mariana Islands (Guam and the Commonwealth of the Northern Mariana Islands (CNMI)); *E. s. sulcata,* occurring in Chuuk and Pohnpei; *E. s. palauensis,* found in Palau; and *E. s. semicaudata,* occurring in American and Independent Samoa, Tonga, Fiji, and Vanuatu. This candidate assessment form addresses the Mariana Islands subspecies. *E. s. rotensis* is historically known from the Mariana Islands and formerly occurred on Guam and in the CNMI on Rota, Aguiguan, Tinian (known from prehistoric records only), Saipan, and possibly Anatahan and Maug. Currently, *E. s. rotensis* appears to be extirpated from all but one island in the Mariana archipelago. The single remaining population of this subspecies occurs on Aguiguan, CNMI. Threats to this subspecies have not changed over the past year. The primary threats to the subspecies are habitat loss and degradation as a result of feral goat ( *Capra hircus* ) activity on the island of Aguiguan and the taxon's small population size and limited distribution. Predation by nonnative species and human disturbance are also potential threats to the subspecies. The subspecies may be near the point where stochastic events, such as typhoons, are increasingly likely to affect its continued survival. The disappearance of the remaining population on Aguiguan would result in the extinction of the subspecies. The LPN for *E. s. rotensis* remains at 3 because the magnitude of the threats is high, the threats are imminent, and the taxon in question is a subspecies. New England cottontail ( *Sylvilagus transitionalis* )—The following summary is based on information from our files and information collected during the public comment period on the 90-day petition finding. We received the petition on August 30, 2000. The 90-day finding was published on June 30, 2004 (69 FR 39395). The New England cottontail

(NEC)is a medium to large-sized cottontail rabbit that may reach 1,000 grams in weight, and is one of two species within the genus *Sylvilagus* occurring in New England. New England cottontails are considered habitat specialists, in so far as they are dependent upon early-successional habitats typically described as thickets. The species is the only endemic cottontail in New England. Historically, the NEC ranged from southeastern New York (east of the Hudson River) north through the Champlain Valley, southern Vermont, the southern half of New Hampshire, southern Maine and south throughout Massachusetts, Connecticut and Rhode Island. The current range of the NEC has declined substantially and occurrences have become increasingly separated. The species' distribution is fragmented into five apparently isolated metapopulations in about 14 percent of the species' historic range. The area occupied by the cottontail has contracted from approximately 90,000 sq km to 12,180 sq km. It is estimated that less than one third of the occupied sites occur on lands in conservation status and fewer than 10 percent are being managed for early successional forest species. The primary threat to the New England cottontail is loss of habitat through succession and alteration. Isolation of occupied patches by areas of unsuitable habitat and high predation rates are resulting in local extirpation of New England cottontails from small patches. The range of the New England cottontail has contracted by 75 percent or more since 1960 and current land uses in the region indicate that the rate of change, about two percent range loss per year, will continue. Additional threats include competition for food and habitat with introduced eastern cottontails and large numbers of native white-tailed deer; inadequate regulatory mechanisms in effect to protect the habitat; and mortality from predation. Based on threats of high magnitude that are imminent, we assigned this species an LPN of 2. Fisher, West Coast DPS ( *Martes pennanti* )—The following summary is based on information in our files and in the Service's initial warranted-but-precluded finding published in the **Federal Register** on April 8, 2004 (68 FR 18770). The fisher is a carnivore in the family Mustelidae and is the largest member of the genus Martes. Historically, the West Coast population of the fisher extended south from British Columbia into western Washington and Oregon, and in the North Coast Ranges, Klamath-Siskiyou Mountains, and Sierra Nevada in California. The fisher is believed to be extirpated or reduced to scattered individuals from the lower mainland of British Columbia through Washington and in the central and northern Sierra Nevada range in California. Native populations of fisher currently occur in the North Coast Ranges of California, the Klamath-Siskiyou Mountains of northern California and southern Oregon, and in isolated populations occurring in the southern Sierra Nevada in California. Descendents of a fisher reintroduction effort also occur in the southern Cascade Range in Oregon. There is a lack of precise empirical data on West Coast DPS fisher numbers. However, there is a lack of detections over much of the fisher's historic range, even with standardized survey and monitoring efforts in California, Oregon, and Washington. There is also a high degree of genetic relatedness within some populations, and populations of native fisher in California are separated by four times the species' maximum dispersal distance. The above listed factors all indicate that the likely extant fisher populations are small and isolated from one another. Major threats that fragment or remove key elements of fisher habitat include various forest vegetation management practices such as timber harvest and fuels reduction treatments. Other potential major threats include: Stand-replacing fire, Sudden Oak Death Phytophthora, urban and rural development, recreation development, and highways. Major threats to fisher that lead to direct mortality and injury to fisher include: Collisions with vehicles; predation; and viral borne diseases such as rabies, parvovirus, canine distemper, and *Anaplasma phagocytophilum.* Existing regulatory mechanisms on Federal, State, and private lands affect key elements of fisher habitat and do not provide sufficient certainty that conservation efforts will be effective or will be implemented. The magnitude of threats is high as they occur across the range of the DPS resulting in a negative impact on fisher distribution and abundance. However, the threats are nonimminent as the greatest long-term risks to the fisher in its west coast range are the subsequent ramifications of the isolation of small populations, and the three remaining areas containing fisher populations appear to be stable or not rapidly declining based on recent survey and monitoring efforts. Therefore, we assigned an LPN of 6 to this population. Mazama pocket gopher ( *Thomomys mazama* ssp. *couchi, douglasii, glacialis, louiei, melanops, pugetensis, tacomensis, tumuli, yelmensis* )—The following summary is based on information contained in our files. No new information was provided in the petition received December 11, 2002. Since publication of our last CNOR, the Brush Prairie pocket gopher was recently discovered to have been erroneously assigned to another species, *T. talpoides douglasii* (a northern pocket gopher). Mitochondrial DNA analysis determined that it is actually a subspecies of *T. mazama,* thus we are now including this subspecies in our candidate list as *T. m. douglasii.* Seven of these nine subspecies of pocket gopher are associated with glacial outwash prairies in western Washington ( *T. m. melanops* is found on alpine meadows in Olympic National Park, and *T. m. douglasii* is found in extreme southwest Washington). Of these seven subspecies, five are likely still extant ( *couchi, glacialis, pugetensis, tumuli,* and *yelmensis* ); two of the subspecies ( *louiei* and *tacomensis* ) are likely extinct. Few of these glacial outwash prairies remain in Washington today. Historically, such prairies were patchily distributed, but the area they occupied was approximately 170,000 acres. Now, residential and commercial development, and ingrowth of woody and/or nonnative vegetation (often due to fire-regime alteration) have further reduced their extent of suitable habitats. In addition, development in or adjacent to these prairies has likely increased predation on Mazama pocket gophers by dogs and cats. The magnitude of threat is high due to populations with patchy and isolated distributions in habitats highly desirable for development and subject to a wide variety of human activities that permanently alter the habitat. The threat of invasive plant species to the quality of a highly specific habitat requirement is high and constant. There are few known populations of each subspecies. A limited dispersal capability and the loss and degradation of additional patches of appropriate habitat will further isolate populations and increase their vulnerability to extinction. Loss of any of the subspecies will reduce the genetic diversity and the likelihood of continued existence of the *Thomomys mazama* subspecies complex in Washington. The threats are imminent as they are ongoing. Gravel pits threaten persistence of one of the subspecies (Roy Prairie), and the largest populations of two other subspecies (Shelton and Olympia) are located on airports with planned development. Yelm pocket gophers are also threatened by proposed development on Fort Lewis, and ongoing development in Olympia. Thus, we assign an LPN of 3 to these subspecies. Palm Springs round-tailed ground squirrel ( *Spermophilus tereticaudus chlorus* )—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Palm Springs round-tailed ground squirrel is one of four recognized subspecies of round-tailed ground squirrels. The range of this squirrel is limited to the Coachella Valley region of Riverside County, California. Primary habitat for the Palm Springs round-tailed ground squirrel is the dunes and hummocks associated with *Prosopis glandulosa* var. *torreyana* (honey mesquite) and to a lesser extent those dunes and hummocks associated with *Larrea tridentata* (creosote), or other vegetation. Rapid growth of desert cities such as Palm Springs and Palm Desert in the Coachella Valley has raised concerns about the conservation of the narrowly distributed Palm Springs round-tailed ground squirrel. Urban development and drops in the groundwater table have eliminated 90 percent of the honey mesquite in the Coachella Valley. Furthermore, urban development has fragmented habitat occupied by this squirrel thereby isolating populations. The high rate of urban development and associated lowering of the groundwater table that was likely historically responsible for the high losses of honey mesquite sand dune/hummocks habitat continues today. We continue to assign the Palm Springs ground squirrel subspecies a listing priority of 3 because the threats are ongoing and are of a high magnitude as they affect a large portion of its' range. Southern Idaho ground squirrel ( *Spermophilus brunneus endemicus* )—The following summary is based on information contained in our files. The southern Idaho ground squirrel is endemic to four counties in southwest Idaho; its total known range is approximately 425,630 hectares (1,051,752 acres). Threats to southern Idaho ground squirrels include: habitat deterioration and fragmentation; direct killing from shooting, trapping, or poisoning; predation; competition with Columbian ground squirrels; and inadequacy of existing regulatory mechanisms. Habitat deterioration and fragmentation appear to be the primary threats to the species. Nonnative annuals now dominate much of this species' range, have changed the species composition of vegetation, and have altered the fire regime in a perpetuating cycle throughout much of the range. Habitat deterioration, destruction, and fragmentation are thought to have resulted in the current patchy distribution of southern Idaho ground squirrels. Based on recent genetic work, southern Idaho ground squirrels are subject to more genetic drift and inbreeding than expected. Cost effective methods of habitat restoration are currently unknown for southern Idaho ground squirrels. Two Candidate Conservation Agreements with Assurances (CCAAs) have been completed for this species, both of which allow agency access for population and habitat surveys and habitat enhancement/restoration work. The magnitude of threat is moderate for this species because habitat degradation remains the primary threat to the species in some areas where the species is found. While some habitat restoration has taken place, restoration has not yet occurred on a meaningful scale to further reduce the magnitude or eliminate this threat. The immediacy of the threat is imminent for this species due to the ongoing threat from the prevalence and dominance of nonnative vegetation and the current patchy distribution of the species. Thus, we assign an LPN of 9 to this subspecies. Washington ground squirrel ( *Spermophilus washingtoni* )—The following summary is based on information contained in our files and in the petition we received on March 2, 2000. The Washington ground squirrel is one of the smallest members of the subgenus Spermophilus and is found within the shrub-steppe habitat of the Columbia Basin ecosystem of Oregon and Washington. The soil types used by the squirrels are distributed sporadically within the species' range, and have been significantly fragmented by human development in the Columbia Basin. Approximately two-thirds of the Washington ground squirrel's total historical range has been converted to agriculture. When agriculture occurs, little evidence of ground squirrel use has been documented, and reports indicate that agriculture (along with other development) continues to eliminate Washington-ground-squirrel habitat in portions of its range. Most remaining habitat is threatened by the occurrence and spread of nonnative species, particularly cheatgrass. Nonnative plants threaten squirrels by out-competing native plants, thereby altering available cover, food quantity and quality, and altering fire intervals. The ultimate effects of cheatgrass invasion on this species are not fully understood. While Washington ground squirrels eat cheatgrass, it is not likely a viable long-term dietary option since cheatgrass populations are unstable during drought and cheatgrass contains large amounts of indigestible silica which may make it a poor nutrition source. Fire recurrence intervals typically switch from 20-100 years in sagebrush-grassland ecosystems to 3-5 years in cheatgrass-dominant sites. Increased fire occurrence reduces native bunchgrass and shrub cover (by competition or preventing the re-establishment of shrub cover) and allows exotic species to further out-compete native species. The most contiguous, least-disturbed expanse of suitable Washington-ground-squirrel habitat within the species' range occurs on the Boeing site and Naval Weapons Training Facility near Boardman, Oregon. In Washington, the largest expanse of known suitable habitat occurs on State and Federal land. In Washington, recent declines in some colonies have been precipitous for unknown (possibly weather-related) reasons. Recent surveys have located additional sites in Washington and Oregon. However, detections are primarily located in the three disjunct metapopulations, indicating that fragmentation and increased vulnerability to natural and man-made factors is still a widespread threat. In Oregon, some threats are addressed by the State listing of this species, and by the recently signed Threemile Canyon Farms Multi-Species Candidate Conservation Agreement with Assurances (Agreement). Current threats to the long-term persistence of this species include the following: historical and current habitat loss from the conversion of habitat to agriculture and other development, habitat fragmentation, limited dispersal corridors, recreational shooting, genetic isolation and drift, spread of nonnative species, and predation. Potential threats include disease, drought, and possible competition with related ground-squirrel species in disturbed habitat at the periphery of their range. While there are a variety of conservation actions and research activities, they do not address all of the threats throughout the species' range. Due to the widespread current and potential threats to the species we conclude the magnitude of threats remains high. Because the Agreement addressed the imminent loss of a large portion of habitat to agriculture, and because there are no other known, large-scale efforts to convert suitable habitat to agriculture, the threats, overall, are nonimminent. We, therefore, kept the LPN at 5. Birds Spotless crake, American Samoa DPS ( *Porzana tabuensis* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *P. tabuensis* is a small, dark, cryptic rail found in wetlands and rank scrub or forest in the Philippines, Australia, Fiji, Tonga, Society Islands, Marquesas, Independent Samoa, and American Samoa (Ofu, Tau). The genus Porzana is widespread in the Pacific, where it is represented by numerous island-endemic and flightless species (many of which are extinct as a result of anthropogenic disturbances) as well as several more cosmopolitan species, including *P. tabuensis* . No subspecies of *P. tabuensis* are recognized. The American Samoa population is the only population of spotless crakes under U.S. jurisdiction. The available information indicates that distinct populations of the spotless crake, a species not noted for long-distance dispersal, are definable. The population of spotless crakes in American Samoa is discrete in relation to the remainder of the species as a whole, which is distributed in widely separated locations. Although the spotless crake (and other rails) have dispersed widely in the Pacific, island rails have tended to reduce or lose their power of flight over evolutionary time and so become isolated (and vulnerable to terrestrial predators such as rats). The population of this species in American Samoa is therefore distinct based on geographic and distributional isolation from spotless crake populations on other islands in the oceanic Pacific, the Philippines, and Australia. The American Samoa population of the spotless crake links the Central and Eastern Pacific portions of the species' range. The loss of this population could cause an increase of roughly 500 miles (805 kilometers) in the disjunction between the central and eastern Polynesian portions of the spotless crake's range, and could result in the isolation of the Marquesas and Society Islands populations by further limiting the potential for even rare genetic exchange. Based on the discreteness and significance of the American Samoa population of the spotless crake, we consider this population to be a distinct vertebrate population segment which warrants review for listing under the Act. Threats to this species have not changed over the past year. The population in American Samoa is threatened by small population size, limited distribution, predation by nonnative mammals, continued development of wetland habitat, and natural catastrophes such as hurricanes. The co-occurrence of a known predator of ground-nesting birds, the Norway rat ( *Rattus norvegicus* ), and the only known population of the spotless crake under U.S. jurisdiction, along with the extremely restricted observed distribution and low numbers, indicate that the American Samoa distinct population segment of this species continues to merit status as a candidate for listing. Based on our assessment of existing information about the imminence and high magnitude of these threats, we assigned the spotless crake an LPN of 3. Kauai creeper ( *Oreomystis bairdi* )—We have not updated our candidate assessment for this species as we are currently developing a proposed listing rule. Yellow-billed cuckoo, western U.S. DPS ( *Coccyzus americanus* )—The following summary is based on information contained in our files and the petition we received on February 9, 1998. See also our 12-month petition finding published on July 25, 2001 (66 FR 38611). The yellow-billed cuckoo is a medium-sized bird of about 12 inches (30 centimeters) in length with a slender, long-tailed profile and a fairly stout and slightly down-curved bill. Plumage is grayish-brown above and white below, with rufous primary flight feathers with the tail feathers boldly patterned with black and white below. Western cuckoos breed in large blocks of riparian habitats (particularly woodlands with cottonwoods ( *Populus fremontii* ) and willows ( *Salix* sp.). Dense understory foliage appears to be an important factor in nest site selection, while cottonwood trees are an important foraging habitat in areas where the species has been studied in California. We consider the yellow-billed cuckoos that occur in the western United States as a distinct population segment (DPS). The area for this DPS is west of the crest of the Rocky Mountains. The threats currently facing the yellow-billed cuckoo include habitat loss, cattle grazing, and pesticide application. Principal causes of riparian habitat losses are conversion to agricultural and other uses, dams and river flow management, stream channelization and stabilization, and livestock grazing. Available breeding habitats for cuckoos have also been substantially reduced in area and quality by groundwater pumping and the replacement of native riparian habitats by invasive nonnative plants, particularly tamarisk. Overuse by livestock has been a major factor in the degradation and modification of riparian habitats in the western United States. The effects include changes in plant community structure and species composition and in relative abundance of species and plant density. These changes are often linked to more widespread changes in watershed hydrology. Livestock grazing in riparian habitats typically results in reduction of plant species diversity and density, especially of palatable broadleaf plants like willows and cottonwood saplings, and is one of the most common causes of riparian degradation. In addition to destruction and degradation of riparian habitats, pesticides may affect cuckoo populations. In areas where riparian habitat borders agricultural lands, e.g., in California's central valley, pesticide use may indirectly affect cuckoos by reducing prey numbers, or by poisoning nestlings if sprayed directly in areas where the birds are nesting. We retain an LPN of 3 for the yellow-billed cuckoo due to imminent threats of a high magnitude. Friendly ground-dove, American Samoa DPS ( *Gallicolumba stairi stairi* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Streaked horned lark ( *Eremophila alpestris strigata* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on December 11, 2002. The streaked horned lark occurs in Washington and Oregon, and is thought to be extirpated in British Columbia, Canada. In Washington, surveys show that there are approximately 330 remaining breeding birds. In Oregon, the breeding population is estimated to be approximately 400 birds. The streaked horned lark's breeding habitat continues to be threatened by loss and degradation due to conversion of native grasslands to other uses (such as agriculture, homes, recreational areas, and industry), encroachment of woody vegetation, and invasion of nonnative plant species (e.g., Scot's broom, sod-forming grasses, and beachgrasses). Wintering habitats are seemingly few, and susceptible to unpredictable conversion to unsuitable over-wintering habitat. Where larks inhabit manmade habitats similar in structure to native prairies (such as airports, military reservations, agricultural fields, and dredge-formed islands), or where they occur adjacent to human habitation, they are subjected to a variety of unintentional human disturbances such as mowing, recreational and military activities, plowing, flooding, and dredge spoil dumping during the nesting season, as well as intentional disturbances such as at the McChord Air Force Base where falcons and dogs are used to haze the birds in order to prevent aircraft collisions. In some areas, landowners have taken steps to improve streaked-horned-lark nesting habitat. The magnitude of threat is high due to small populations with low genetic diversity and patchy and isolated habitats in areas desirable for development, many of which remain unsecured. The threat of invasive plant species is high and constant, aside from a few restoration sites. The numbers of individuals are low and the numbers of populations are few. Over-wintering birds are concentrated in larger flocks and subject to unpredictable wintering habitat loss (especially in Oregon), potentially affecting a large portion of the population at one time. In Washington, known populations occur on airports, military bases, coastal beaches, and Columbia River islands, where management, training activities, recreation, and dredge spoil dumping continue to negatively affect streaked-horned-lark breeding and wintering. In Oregon, breeding and wintering sites occur on Columbia River islands, in cultivated grass fields, grazed pastures, fallow fields, roadside shoulders, Christmas tree farms, and wetland mudflats. Such areas continue to be subject to negative impacts such as dredge spoil dumping, development, plowing, mowing, pesticide and herbicide applications, trampling, vehicle traffic, and recreation. The threats are imminent due to the continued loss of suitable lark habitat, risks to the wintering populations, plans for development on and adjacent to several of its nesting areas, use of falcons and dogs to haze breeding birds at McChord AFB, planned and/or continued expansions of the McChord AFB West Ramp and Olympia Airport, and annual Air Force military training and fire-bombing on top of lark nesting habitat. We continue to assign an LPN of 3 to this species. Red knot ( *Calidris canutus rufa* )—The following summary is based on information from our files and information provided by petitioners. We received one petition on August 9, 2004, and two others were each received on August 5, 2005. The *rufa* subspecies is one of six recognized subspecies of red knot and one of three subspecies occurring in North America (hereafter all mention of red knot refers strictly to the *rufa* subspecies). This subspecies makes one of the longest distance migrations known in the animal kingdom as it travels between breeding areas in the central Canadian Arctic and wintering areas that are primarily in southern South America along the coast of Chile and Argentina. They migrate along the Atlantic coast of the United States, where they may be found from Maine to Florida. The Delaware Bay area (in Delaware and New Jersey) is the largest known spring migration stopover area, with far fewer migrants congregating elsewhere along the Atlantic coast. The concentration in the Delaware Bay area occurs from the middle of May to early June, corresponding to the spawning season of horseshoe crabs. The knots feed on horseshoe crab eggs, rebuilding energy reserves needed to complete migrations to the Arctic and arrive on the breeding grounds in good condition. Surveys at wintering areas and at Delaware Bay during spring migration indicate a substantial decline in recent years. At the Delaware Bay area, peak counts between 1982 and 1998 were as high as 95,360 knots. Although counts may vary considerably between years, some of the population fluctuations can be attributed to predator-prey cycles in the breeding grounds, and counts show that knots rebound from such reductions. In the past, horseshoe crab eggs were so numerous that a knot could eat enough in two to three weeks to double its weight. Research shows that from 1997 to 2002 an increasing proportion of red knots leaving the Delaware Bay failed to achieve threshold departure masses needed to fly to breeding grounds and survive an initial few days of snow cover, and this corresponded to reduced annual survival rates. Recently, peak counts at the Delaware Bay area have been lower than in the past and do not show a rebound. The peaks were 13,315 in 2004, 15,345 in 2005, and 13,455 in 2006. Counts in recent years at the principal wintering areas in South America also are substantially lower than in the past and do not show a rebound. The primary factor threatening the red knot is destruction and modification of its habitat, particularly the reduction in key food resources resulting from reductions in horseshoe crabs, which are harvested primarily for use as bait and secondarily to support a biomedical industry. Commercial harvest increased substantially in the 1990's. Since 1999, a series of timing restrictions and substantially lower harvest quotas have been adopted by the Atlantic States Marine Fisheries Commission (ASMFC), as well as New Jersey and Delaware. In May 2006, the ASMFC adopted restrictions effective from October 1, 2006, to September 30, 2008, including a prohibition on harvest and landing of horseshoe crabs in New Jersey and Delaware from January 1 through June 7, harvest of males only from June 8 through December 31, and harvest limited to no more than 100,000 horseshoe crabs per state per year. The ASMFC also adopted other restrictions applicable to Maryland and Virginia. New Jersey has established restrictions which supersede those of the ASMFC; as a result there is a moratorium on all horseshoe crab harvest in New Jersey from May 15, 2006 through June 7, 2008, after which the restrictions adopted by ASMFC apply. In February 2007, Delaware imposed a two-year moratorium, effective January 1, 2007, on harvest of horseshoe crabs within Delaware lands or waters. In June 2007, following litigation by two businesses involved in the harvesting and sale of horseshoe crabs, Delaware's moratorium was overturned. Consequently Delaware developed regulations allowing for a male-only horseshoe crab harvest, consistent with restrictions adopted by ASMFC. The reductions in commercial harvest since 1999 are substantial: 726,660 horseshoe crab landings for bait were reported in 1999 in Delaware and New Jersey, compared to 173,177 in 2004. However, we do not know whether horseshoe crab populations will rebuild or how long a lag time there may be in increased availability of eggs, as they need 8 to 10 years to reach sexual maturity and other key information for estimating population response is lacking. A survey in Delaware Bay showed spawning activity was stable or slightly declining from 1999 to 2004. In 2004, availability of horseshoe crab eggs on principal shorebird foraging beaches increased over recent years. The peak number of migrant red knots observed at Delaware Bay increased slightly in 2005 compared to 2004, and in 2006 the peak count was similar to that in 2004. Also, body weights of red knots at the time of departure from Delaware Bay improved in 2005 over previous years. Counts of red knots at key wintering areas in South America, although much reduced from the past, were similar in 2007 to the counts in 2006 and 2005. Thus in recent years the number of knots has been much lower than in the past and the trend in the abundance is not improving despite a four-fold reduction in horseshoe crab landings since the late 1990s. Other identified threat factors include habitat destruction due to beach erosion and various shoreline protection and stabilization projects that are impacting areas used by migrating knots for foraging, the inadequacy of existing regulatory mechanisms, human disturbance, and competition with other species for limited food resources. Also, the concentration of red knots in the Delaware Bay areas and at a relatively small number of wintering areas make the species vulnerable to potential large-scale events in those areas such as oil spills or severe weather. Overall, we conclude that the major threat, the modification of habitat through harvesting of horseshoe crabs to such an extent that it puts the viability of the knot at substantial risk, is of a high magnitude, but is nonimminent because of reductions and restrictions on harvesting horseshoe crabs. Based on nonimminent threats of a high magnitude, we retain an LPN of 6 for this subspecies. Kittlitz's murrelet ( *Brachyramphus brevirostris* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files and the petition we received on May 9, 2001. Xantus's murrelet ( *Synthliboramphus hypoleucus* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files and the petition we received on April 16, 2002. Lesser prairie-chicken ( *Tympanuchus pallidicinctus* )—The following summary is based on information contained in our files and the petition received on October 5, 1995. Additional information can be found in the 12-month finding published on June 7, 1998 (63 FR 31400). Biologists estimate that the occupied range has declined by 92 percent since the 1800s. The most serious threats to the lesser prairie-chicken are loss of habitat from conversion of native rangelands to introduced forages and cultivation, cumulative habitat degradation caused by severe grazing, woody plant invasion of open prairies, fire suppression, herbicides, and habitat fragmentation caused by structural and transportation developments. Many of these threats may exacerbate the normal effects of periodic drought on lesser prairie-chicken populations. In many cases, the remaining suitable habitat has become fragmented by the spatial arrangement of these individual threats. Habitat fragmentation can be a threat to the species through several mechanisms: remaining habitat patches may become smaller than necessary to meet the requirements of individuals and populations, necessary habitat heterogeneity may be lost to areas of homogeneous habitat structure, areas between habitat patches may harbor high levels of predators or brood parasites, and the probability of recolonization decreases as the distance between suitable habitat patches expands. Based on all currently available information, we find that ongoing threats to the lesser prairie-chicken, as outlined in the 12-month finding, remain unchanged and lesser prairie-chickens continue to warrant federal listing as threatened. We have determined that the overall magnitude of threats to the lesser prairie-chicken throughout its range is moderate, and that the threats are ongoing and thus, imminent. Consequently, an LPN of 8 remains appropriate for the species. Greater sage-grouse, Columbia Basin DPS ( *Centrocercus urophasianus* )—We have not updated our finding with regard to the Columbia Basin DPS of the greater sage-grouse in this notice. The following summary is based on information in our files and a petition, dated May 14, 1999, requesting the listing of the Washington population of western sage-grouse ( *C. u. phaios* ). Pursuant to Service policy (61 FR 4722), on May 7, 2001, we concluded that listing the Columbia Basin DPS of western sage-grouse, which was historically found in northern Oregon and central Washington, was warranted, but precluded by higher priority listing actions (66 FR 22984). In the May 4, 2004, notice, we found that a listing proposal for this DPS was still warranted but precluded by higher priorities, and maintained its LPN of 6. In the intervening time, the Service received two petitions requesting the listing of the entire ranges of the nominal western and eastern subspecies of greater sage-grouse, dated January 24 and July 3, 2002, respectively. However, based on communications with recognized sage-grouse experts, disagreement as to the validity of an eastern and western subspecies of sage-grouse existed. Due to this disagreement in the scientific community, the Service evaluated the available information with regard to our section 4 listing responsibilities under the Endangered Species Act (USFWS 1992). The Service subsequently concluded that the eastern and western subspecies designations for greater sage-grouse are inappropriate given current taxonomic standards (68 FR 6500 and 69 FR 933). The Institute for Wildlife Protection filed a court complaint, dated June 6, 2003, challenging the merits of the 90-day finding. On August 10, 2004, a U.S. District Court judge issued an order in favor of the USFWS and dismissing the plaintiff's case. An appeal, dated November 24, 2004, was filed by the Institute for Wildlife Protection regarding this decision. On March 3, 2006, the 9th Circuit Court remanded the finding back to the Service to revisit the 90-day finding regarding the conclusion that the western sage-grouse is not a subspecies. The Court did uphold that the petitioned population (western sage-grouse) does not constitute a DPS. We will publish an updated finding addressing the Columbia Basin DPS in the **Federal Register** following our assessment of the remand. Band-rumped storm-petrel, Hawaii DPS ( *Oceanodroma castro* )—The following summary is based on information contained in our files and the petition we received on May 8, 1989. No new information was provided in the second petition received on May 11, 2004. The band-rumped storm-petrel is a small seabird that is found in several areas of the subtropical Pacific and Atlantic Oceans. In the Pacific, there are three widely separated breeding populations—one in Japan, one in Hawaii, and one in the Galapagos. Populations in Japan and the Galapagos are comparatively large and number in the thousands, while the Hawaiian birds represent a small, remnant population of possibly only a few hundred pairs. Band-rumped storm-petrels are most commonly found in close proximity to breeding islands. The three populations in the Pacific are separated by long distances across the ocean where birds are not found. Extensive at-sea surveys of the Pacific have revealed a broad gap in distribution of the band-rumped storm-petrel to the east and west of the Hawaiian Islands, indicating the distribution of birds in the central Pacific around Hawaii is disjunct from other nesting areas. The available information indicates that distinct populations of band-rumped storm-petrels are definable and that the Hawaiian population is distinct based on geographic and distributional isolation from other band-rumped storm-petrel populations in Japan, the Galapagos, and the Atlantic Ocean. A population also can be considered discrete if it is delimited by international boundaries across which exist differences in management control of the species. The Hawaiian population of the band-rumped storm-petrel is the only population within U.S. borders or under U.S. jurisdiction. Loss of the Hawaiian population would cause a significant gap in the distribution of the band-rumped storm-petrel in the Pacific, and could result in the complete isolation of the Galapagos and Japan populations without even occasional genetic exchanges. The band-rumped storm-petrel probably was common on all of the main Hawaiian Islands when Polynesians arrived about 1,500 years ago, based on storm-petrel bones found in middens on the island of Hawaii and in excavation sites on Oahu and Molokai. Nesting colonies of this species in the Hawaiian Islands currently are restricted to remote cliffs on Kauai and Lehua Island and high-elevation lava fields on Hawaii. Vocalizations of the species were heard in Haleakala Crater on Maui as recently as 2006; however, no nesting sites have been located on the island to date. The significant reduction in numbers and range of the band-rumped storm-petrel is due primarily to predation by nonnative predators introduced by humans, including the domestic cat ( *Felis catus* ), small Indian mongoose ( *Herpestes auropunctatus* ), common barn owl ( *Tyto alba* ), black rat ( *R. rattus* ), Polynesian rat ( *Rattus exulans* ), and Norway rat ( *R. norvegicus* ), which occur throughout the main Hawaiian Islands, with the exception of the mongoose, which is not established on Kauai. Attraction of fledglings to artificial lights and collisions with artificial structures such as communication towers and utility lines are also threats. Erosion of nest sites caused by the actions of nonnative ungulates is a potential threat in some locations. Efforts are underway in some areas to reduce light pollution and mitigate the threat of collisions, but there are no large-scale efforts to control nonnative predators in the Hawaiian Islands. Based on the imminent threats of a high magnitude, we assign this distinct population segment an LPN of 3. Elfin-woods warbler ( *Dendroica angelae* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The elfin-woods warbler is a small entirely black and white warbler, distinguished by its white eyebrow stripe, white patches on ear covers and neck, incomplete eye ring, and black crown. *Dendroica angelae* was at first thought to occur only in the high elevation dwarf or elfin forests, but it has since been found at lower elevations, including shade coffee plantations and secondary forests. *Dendroica angelae* builds a compact cup nest, usually close to the trunk and well hidden among the epiphytes of a small tree, and its breeding season extends from March to June. This species forages in the middle part of trees, gleaning insects from leaves in the outer portion of the tree crown. *Dendroica angelae* has been documented from four locations in Puerto Rico: Luquillo Mountains, Sierra de Cayey, and the Commonwealth forests of Maricao and Toro Negro. However, it has not been recorded again in Toro Negro and Cayey, following the passing of Hurricane Hugo in 1989. In 2003 and 2004, surveys were conducted for the elfin-woods warbler in the Carite Commonwealth Forest, Toro Negro Forest, Guilarte Forest, Bosque del Pueblo, Maricao Forest and the Caribbean National Forest, but only detected the species in the latter two. Biologist recorded 778 elfin-woods warblers in the Maricao Commonwealth Forest, and 196 elfin-woods warblers in the Caribbean National Forest. Habitat destruction from expansion of public facilities within the forests, potential construction of additional telecommunication towers and their maintenance, disruption of breeding activities from pedestrians and high human use areas, switching from shade to sun coffee plantations, timber management practices, potential predators, and catastrophic natural events such as hurricanes and forest fires, threaten this species. Although these threats are not imminent, because most of the range of *Dendroica angelae* is within protected lands the magnitude of threat to *Dendroica angelae* is considered high, due to its restricted distribution and low population numbers. Therefore, we assign an LPN of 5 to this species. Reptiles Sand dune lizard ( *Sceloporus arenicolus* )—The following summary is based on information contained in our files and in the petition we received June 6, 2002. The sand dune lizard is endemic to a small area in southeastern New Mexico (Chaves, Eddy, Lea, and Roosevelt Counties) and adjacent west Texas (Andrews, Crane, Gaines, Ward, and Winkler Counties). Within this area, the known occupied and potentially occupied habitat is only 1,697 square kilometers (655 square miles) in New Mexico, and an area of unknown size in west Texas. The sand dune lizard's distribution is localized and fragmented (i.e., known populations are separated by vast areas of unoccupied habitat), and the species is restricted to sand dune blowouts associated with active sand dunes and shinnery oak ( *Quercus harvardii* ) and scattered sandsage ( *Artemisia filifolia* ) vegetation. Sand dune lizards are not found at sites lacking shinnery oak dune habitat. It is clear that shinnery oak removal (e.g., by treating with the herbicide Tebuthiuron for livestock range improvements) results in dramatic reductions and extirpation of sand dune lizards. Scientists repeatedly confirmed the extirpation of sand dune lizards from areas with herbicide treatment to remove shinnery oak. In 1999, biologists estimated that about 25 percent of the total sand dune lizard habitat in New Mexico had been eliminated in the previous 10 years. The population of sand dune lizards has also been affected by oil and gas field development. An estimated 50-percent decline in sand dune lizard populations can be expected in areas with approximately 25 to 30 oil and/or gas wells per section. Because the distribution of sand dune lizards is localized and fragmented, and this species is a habitat specialist, impacts to its habitat will most likely greatly decrease populations. If current herbicide application continues and oil and gas development progresses as expected, the magnitude of threat to sand dune lizards will increase. Continued pressure to develop oil and gas resources in areas with sand dune lizards poses an imminent threat to the species. Therefore, we continue to assign this species an LPN of 2. Eastern massasauga ( *Sistrurus catenatus catenatus* )—The following summary is based on information contained in our files. No new information was provided in the petition received on May 11, 2004. The eastern massasauga is one of three recognized subspecies of massasauga. It is a small, thick-bodied rattlesnake that occupies shallow wetlands and adjacent upland habitat in portions of Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, Wisconsin, and Ontario. Although the current range of *S. c. catenatus* resembles the subspecies' historical range, the geographic distribution has been restricted by the loss of the subspecies from much of the area within the boundaries of that range. Approximately 40 percent of the counties that were historically occupied by *S. c. catenatus* no longer support the subspecies. *S. c. catenatus* is currently considered imperiled in every State and province which it occupies. Each State and Canadian province across the range of *S. c. catenatus* has lost more than 30 percent, and for the majority more than 50 percent, of their historical populations. Furthermore, less than 35 percent of the remaining populations are considered secure. Approximately 59 percent of the remaining *S. c. catenatus* populations occur wholly or in part on public land, and Statewide and/or site-specific Candidate Conservation Agreements with Assurances (CCAAs) are currently being developed for many of these areas in Iowa, Illinois, Michigan, and Wisconsin. In 2006, a CCAA with the Ohio Department of Natural Resources Division of Natural Areas and Preserves was completed for Rome State Nature Preserve in Ashtabula County. Populations soon to be under CCAs and CCAAs have a high likelihood of persisting and remaining viable. Other populations are likely to suffer additional losses in abundance and genetic diversity and some will likely be extirpated unless threats are removed in the near future. Because of the ongoing efforts to protect the subspecies through CCAAs, the magnitude of threats from habitat modification, habitat succession, incompatible land management practices, illegal collection for the pet trade, and human persecution is moderate overall, with most imminent threats occurring to remaining populations on private lands. Due in large part to the numerous CCAAs currently being developed and implemented, we do not believe emergency listing is warranted and have kept the LPN at 9 for this subspecies. Black pine snake ( *Pituophis melanoleucus lodingi* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. There are historical records for the black pine snake from one parish in Louisiana, 14 counties in Mississippi, and 3 counties in Alabama west of the Mobile River Delta. Black pine snake surveys and trapping indicate that this species has been extirpated from Louisiana and from four counties in Mississippi. Moreover, the distribution of remaining populations has become highly restricted due to the destruction and fragmentation of the remaining longleaf pine habitat within the range of the species. Most of the known Mississippi populations are concentrated on the DeSoto National Forest. Populations occurring on properties managed by State and other governmental agencies as gopher tortoise mitigation banks or wildlife sanctuaries represent the best opportunities for long-term survival of the species in Alabama. Other factors affecting the black pine snake include vehicular mortality and low reproductive rates, which magnify other threats and increase the likelihood of local extinctions. Due to the imminent threats of high magnitude caused by the past destruction of most of the longleaf pine habitat of the black pine snake, and the continuing persistent degradation of what remains, we assigned an LPN of 3 to this subspecies. Louisiana pine snake ( *Pituophis ruthveni* )—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files and the petition we received on July 19, 2000. Sonoyta mud turtle ( *Kinosternon sonoriense longifemorale* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Sonoyta mud turtle occurs in a spring and pond at Quitobaquito Springs on Organ Pipe Cactus National Monument in Arizona, and in the Rio Sonoyta and Quitovac Spring of Sonora, Mexico. Loss and degradation of stream habitat from water diversion and groundwater pumping, along with its very limited distribution, is the primary threat to the Sonoyta mud turtle. Sonoyta mud turtles are highly aquatic and depend on permanent water for survival. The area of southwest Arizona and northern Sonora where the Sonoyta mud turtle occurs is one of the driest regions of the southwest. Due to continuing drought, irrigated agriculture, and development in the region, surface water in the Rio Sonoyta can be expected to dwindle further. This species may also be vulnerable to aerial spraying of pesticides on nearby agricultural fields. We retained an LPN of 3 for this subspecies because threats are of a high magnitude and continue to date, and therefore, are imminent. Amphibians Columbia spotted frog, Great Basin DPS ( *Rana luteiventris* )—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files and the petition we received on May 1, 1989. Mountain yellow-legged frog, Sierra Nevada DPS ( *Rana muscosa* )—The following summary is based on information contained in our files and the petition received on February 8, 2000. Also see our 12-month petition finding published on January 16, 2003 (68 FR 2283) and our amended 12-month petition finding published on June 25, 2007 (72 FR 34657). The mountain yellow-legged frog inhabits the high elevation lakes, ponds, and streams in the Sierra Nevada Mountains of California, from near 4,500 feet

(ft)(1,370 meters (m)) to 12,000 ft (3,650 m). The distribution of the mountain yellow-legged frog is from Butte and Plumas counties in the north to Tulare and Inyo counties in the south. A separate population in southern California is already listed as endangered (67 FR 44382). Predation by introduced trout is the best-documented cause of the decline of the Sierra Nevada mountain yellow-legged frog, because it has been repeatedly observed that nonnative fishes and mountain yellow-legged frogs rarely co-exist. Mountain yellow-legged frogs and trout (native and nonnative) do co-occur at some sites, but these co-occurrences probably are mountain yellow-legged frog populations with negative population growth rates in the absence of immigration. To help reverse the decline of the mountain yellow-legged frog, the Sequoia and Kings Canyon National Parks have been removing introduced trout since 2001. Over 18,000 introduced trout have been removed from 11 lakes since the project started in 2001. The lakes are completely- to mostly fish-free and substantial mountain yellow-legged frog population increases have resulted. The California Department of Fish and Game

(CDFG)has also removed or is in the process of removing nonnative trout from a total of between 10 and 20 water bodies in the Inyo, Humboldt-Toiyabe, Sierra, and El Dorado National Forests. In the El Dorado National Forest golden trout were removed from Leland Lakes, and attempts have been made to remove trout from two sites near Gertrude Lake and a tributary of Cole Creek; no data showing increase in mountain yellow-legged frogs at these sites was available. In California, chytridiomycosis, more commonly known as chytrid fungus, has been detected in many amphibian species, including the mountain yellow-legged frog within the Sierra Nevada. Recent research has shown that this pathogenic fungus is widely distributed throughout the Sierra Nevada, and that infected mountain yellow-legged frogs die soon after metamorphosis. Several infected and uninfected populations were monitored in Sequoia and Kings Canyon National Parks over multiple years, documenting dramatic declines and extirpations in infected but not in uninfected populations. In the summer of 2005, 39 of 43 populations assayed in Yosemite National Park were positive for chytrid fungus. The current distribution of the Sierra Nevada mountain yellow-legged frog is restricted primarily to publicly managed lands at high elevations, including streams, lakes, ponds, and meadow wetlands located on national forests, including wilderness and non-wilderness on the forests, and national parks. In several areas where detailed studies of the effects of chytrid fungus on the mountain yellow-legged frog are ongoing, substantial declines have been observed over the past several years. For example, in 2005 surveys in Yosemite National Park mountain yellow-legged frogs were not detectable at 37 percent of 113 sites where they had been observed in 2000-2002; in 2005 in Sequoia and Kings Canyon National Parks mountain yellow-legged frogs were not detected at 47 percent of sites where they had been recorded 3-8 years earlier. A compounding effect of disease-caused extinctions of mountain yellow-legged frogs is that recolonization may never occur, because streams connecting extirpated sites to extant populations now contain introduced fishes, which act as barriers to frog movement within metapopulations. The most recent assessment of the species status in the Sierra Nevada indicates that mountain-yellow legged frogs occur at less than 8 percent of the sites from which they were historically observed. A group of prominent scientists further suggest a 10 percent decline per year in the number of remaining *Rana mucosa* populations and urge the listing of the mountain yellow-legged frogs as endangered. Based on imminent, high-magnitude threats, we continue to assign the population of mountain yellow-legged frog in the Sierra Nevada an LPN of 3. Oregon spotted frog ( *Rana pretiosa* )—The following summary is based on information contained in our files and the petition we received on May 4, 1989. Historically, the Oregon spotted frog ranged from British Columbia to the Pit River drainage in northeastern California. Based on surveys of historical sites, the Oregon spotted frog is now absent from at least 76 percent of its former range. The majority of the remaining Oregon spotted frog populations are small and isolated. The threats to the species' habitat include development, livestock grazing, introduction of nonnative plant species, changes in hydrology due to construction of dams and alterations to seasonal flooding, and poor water quality. Additional threats to the species are predation by nonnative fish and introduced bullfrogs; competition with bullfrogs for habitat; and diseases, such as oomycete water mold *Saprolegnia* and chytrid fungus infections. The magnitude of threat is high for this species because the small populations with patchy and isolated distributions are subject to a wide range of threats to both individuals and their habitats that could seriously reduce or eliminate any of these isolated populations and further reduce the range of the species. Habitat restoration and management actions have not prevented a decline in the reproductive rates in some populations. The threats are imminent because each population is faced with multiple ongoing and potential threats. Therefore, we retain an LPN of 2 for the Oregon spotted frog. Relict leopard frog ( *Rana onca* )—The following summary is based on information contained in our files and the petition we received on May 9, 2002. Relict leopard frogs are currently known to occur only in two general areas in Nevada: near the Overton Arm area of Lake Mead, and Black Canyon below Lake Mead. These two areas comprise a small fraction of the historical distribution of the species, which included springs, streams, and wetlands within the Virgin River drainage downstream from the vicinity of Hurricane, Utah; along the Muddy River, Nevada; and along the Colorado River from its confluence with the Virgin River downstream to Black Canyon below Lake Mead, Nevada and Arizona. Suggested factors contributing to the decline of the species include alteration of aquatic habitat due to agriculture and water development, including regulation of the Colorado River, and the introduction of exotic predators and competitors. In 2005, the National Park Service, in cooperation with the Service and various other Federal, State, and local partners, developed a conservation agreement and strategy which is intended to improve the status of the species through prescribed management actions and protection. Conservation actions identified for implementation in the agreement and strategy include captive rearing tadpoles for translocation and refugium populations, habitat and natural history studies, habitat enhancement, population and habitat monitoring, and translocation. Conservation is proceeding under the agreement; however, additional time is needed to determine whether or not the agreement will be effective in eliminating or reducing the threats to the point that the relict leopard frog can be removed from candidate status. However, because of these conservation efforts the magnitude of existing threats is low to moderate. These threats remain nonimminent since there are no known projects or actions that would adversely affect frog populations or threaten surface water associated with known sites occupied by the frog. We assigned an LPN of 11 to this species. Ozark hellbender ( *Cryptobranchus alleganiensis bishopi* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Since the species was elevated to candidate status in 2001 (66 FR 54808), the known threats have increased. In particular, the 2006 discovery of the amphibian disease chytridiomycosis, caused by the pathogen *Batrachochytrium dendrobatidis* , in captive and remaining wild populations of the Ozark hellbender has made increased protection vital to persistence of this subspecies. Chytridiomycosis has proven fatal to several amphibian species worldwide, as well as to Ozark hellbenders in captivity. The majority (approximately 75 percent) of captive hellbenders at the St. Louis Zoo (St. Louis, Missouri) that have been infected with chytridiomycosis have died. Deaths relating to chytridiomycosis continue to occur as the St. Louis Zoo staff continues to search for an effective way to treat infected animals. Due to the incidence of *Batrachochytrium dendrobatidis* in the St. Louis Zoo hellbender population, in 2006 the Missouri Department of Conservation began testing wild hellbenders in Missouri for infection of the pathogen. Individuals that tested positive for the pathogen were found in all three Ozark hellbender rivers in Missouri. Although dead animals in the wild have not been seen, animals continue to be seen with increasingly severe abnormalities. These abnormalities have not been linked conclusively with the presence of *Batrachochytrium dendrobatidis* ; however, considering the types of abnormalities documented (e.g., lesions, digit and appendage loss, epidermis sloughing) researchers believe there is likely a connection. In general, researchers have found that abnormalities in Ozark hellbenders are becoming increasingly more severe, often to a level that the animal is approaching death (e.g., missing digits on all/most limbs, missing all/most limbs). Recreational pressures on Ozark hellbender rivers have also increased substantially on an annual basis. The Missouri Department of Conservation reports that gigging popularity and pressure have increased, and present a significant threat to hellbenders during the breeding season as they tend to move greater distances and congregate in small groups where they are an easy target for giggers. Canoe, kayak, and motor/jet boat traffic has increased in recent years on the Jacks Fork, Current, Eleven Point, and North Fork Rivers. The popularity of these float streams has grown to the point that the National Park Service is considering alternatives to reducing the number of boats that can be launched daily by concessionaires. To date, nothing has been done to reduce or ameliorate ongoing threats to Ozark hellbenders. The Ozarks region continues to experience rapid urbanization, expansion of industrial agricultural practices such as concentrated animal feeding operations (chickens, turkeys, hogs, cattle), and logging. No laws are in place to preclude livestock from grazing in riparian corridors and resting in or along streams and rivers. The majority of the Ozarks region in Missouri and Arkansas is comprised of karst topography (caves, springs, sinkholes, and losing streams) further complicating the containment and transport of potential contaminants. In short, the abundance of waste being generated and lack of adequate treatment facilities or practices for both human and livestock waste poses a significant and ever increasing threat to aquatic ecosystems. The decrease in Ozark hellbender range and population size and the shift in age structure are likely due in part to a variety of historic and ongoing activities. The primary causes of these trends are habitat destruction and modification. Among these are impoundment, channelization, and siltation and water quality degradation from a variety of sources, including industrialization, agricultural runoff, mine waste, and timber harvest. Overutilization of hellbenders for commerce and scientific purposes is also likely contributing to their decline. The regulations targeting these threats, including Clean Water Act and state laws, have not prevented Ozark hellbender declines. Finally, most of the remaining Ozark hellbender populations are small and isolated, making them vulnerable to individual catastrophic events and reducing the likelihood of recolonization after localized extinctions. Due to the existence of ongoing, high-magnitude threats and the newly documented presence of chytridiomycosis, we are deliberating whether emergency listing is appropriate for the Ozark hellbender and continue to assign an LPN of 3 to this subspecies. Austin blind salamander ( *Eurycea waterlooensis* )—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Austin blind salamander is known to occur in and around three of the four spring sites that comprise the Barton Springs complex in the City of Austin, Travis County, Texas. Primary threats to this species are degradation of water quality and quantity due to expanding urbanization. The Austin blind salamander depends on a constant supply of clean water in the Edwards Aquifer discharging from Barton Springs for its survival. Urbanization dramatically alters the normal hydrologic regime and water quality of an area. Increased impervious cover caused by development increases the quantity and velocity of runoff that leads to erosion and greater pollution transport. Pollutants and contaminants that enter the Edwards Aquifer are discharged in salamander habitat at Barton Springs and have serious morphological and physiological effects to the salamander. As the human population increases in central Texas, greater demand on groundwater sources occurs. Increased pumping of the Edwards Aquifer can result in reduced springflows that may also have a detrimental impact on the salamander. The Texas Commission on Environmental Quality adopted the Edwards Rules in 1995 and 1997, which require a number of water quality protection measures for new development occurring in the recharge and contributing zones of the Edwards Aquifer. However, Chapter 245 of the Texas Local Government Code permits “grandfathering” of state regulations. Grandfathering allows developments to be exempted from any new local or state requirements for water quality controls and impervious cover limits if the developments were planned prior to the implementation of such regulations. As a result of the grandfathering law, very few developments have followed these ordinances. New developments are still obligated to comply with regulations that were applicable at the time when project applications for development were first filed. In addition, it is significant that even if they were followed with every new development, these ordinances do not span the entire watershed for Barton Springs. Consequently, development occurring outside these jurisdictions can have negative consequences on water quality and thus have an impact on the species. Despite having the Edwards Rules, as well as other local ordinances, in place, 10 years of trend data continues to show that water quality at Barton Springs is declining. Because of the limited distribution of this species, the magnitude of the threats facing it is high. The threats are imminent because urbanization is ongoing and continues to expand over the Barton Springs Segment of the Edwards Aquifer and water quality continues to degrade. Thus, we retain an LPN of 2 for this species. Georgetown salamander ( *Eurycea naufragia* )—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Georgetown salamander is known to occur in spring outlets along five tributaries to the San Gabriel River and one cave in the City of Georgetown, Williamson County, Texas. The Georgetown salamander has a very limited distribution and depends on a constant supply of clean water from the Northern Segment of the Edwards Aquifer for its survival. Primary threats to this species are degradation of water quality and quantity due to expanding urbanization. Increased impervious cover by development increases the quantity and velocity of runoff that leads to erosion and greater pollution transport. Pollutants and contaminants that enter the Edwards Aquifer are discharged from spring outlets in salamander habitat and have serious morphological and physiological effects to the species. As the human population increases in central Texas, greater demand on groundwater sources occurs. Increased groundwater pumping of the Edwards Aquifer results in reduced springflows that may also have a detrimental impact on the salamander. The Texas Commission on Environmental Quality adopted the Edwards Rules in 1995 and 1997, which require a number of water quality protection measures for new development occurring in the recharge and contributing zones of the Edwards Aquifer. However, Chapter 245 of the Texas Local Government Code permits “grandfathering” of State regulations. Grandfathering allows developments to be exempted from any new local or State requirements for water quality controls and impervious cover limits if the developments were planned prior to the implementation of such regulations. As a result of the grandfathering law, very few developments have followed these ordinances. New developments are still obligated to comply with regulations that were applicable at the time when project applications for development were first filed. In addition, it is significant that even if they were followed with every new development, these ordinances do not span the entire watershed for the Edwards Aquifer. The Texas Commission on Environmental Quality has developed voluntary water quality protection measures for development in the Edwards Aquifer region of Texas; however, it is unknown if these measures will be implemented or if they will be effective in maintaining or improving water quality. Development occurring outside the Texas Commission on Environmental Quality's jurisdiction can have negative consequences on water quality and thus have an impact on the species. Despite having the Edwards Rules in place, as well as other local ordinances, 10 years of trend data at Barton Springs in Austin, Texas, continues to show that water quality is declining. Because of the limited distribution of the Georgetown salamander, the magnitude of the threats facing it is high. The threats are also imminent because urbanization is ongoing and continues to expand over the Northern Segment of the Edwards Aquifer. Thus, we retain an LPN of 2 for this species. Salado salamander ( *Eurycea chisholmensis* )—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Salado salamander is historically known to occur in two spring sites, Big Boiling Springs and Robertson Springs, near Salado, Bell County, Texas. Salamanders have not been located at Robertson Springs since 1991. Primary threats to this species are habitat modification and degradation of water quality and quantity due to expanding urbanization. Many of the spring outlets in the City of Salado have been modified by dam construction. Because Big Boiling Springs is located near Interstate 35 and in the center of the city, increasing traffic and urbanization increase threats of contamination from spills, higher levels of impervious cover, and subsequent impacts to groundwater. Several groundwater contamination incidents have occurred within Salado salamander habitat. The Salado salamander depends on a constant supply of clean water from the Northern Segment of the Edwards Aquifer for its survival. Pollutants and contaminants that enter the Edwards Aquifer discharge in salamander habitat and have serious morphological and physiological effects to the salamander. As the human population increases in central Texas, greater demand on groundwater sources occurs. Increased pumping of the Edwards Aquifer can result in reduced springflows that may also have a detrimental impact on the salamander. Controls of nonpoint source pollution in the watershed are implemented through the Edwards Rules (water quality protection measures for the recharge and contributing zones of the Edwards Aquifer) adopted by the Texas Commission on Environmental Quality in 1995 and 1997. Although implementation of the Edwards Rules in other areas of the Northern Segment of the Edwards Aquifer may have the potential to affect conditions at spring sites occupied by the Salado salamander, the jurisdiction of Texas Commission on Environmental Quality does not extend into Bell County. For this reason, compliance with the Edwards Rules is not required in this part of the Edwards Aquifer. There are no other local or regional water protection measures that have been put in place for areas that feed the springs known to be occupied by the Salado salamander. Because of the limited distribution of this species, the magnitude of the threats facing it is high. The threats are also imminent because urbanization is ongoing and contamination events are occurring near spring sites known to support Salado salamanders. Thus, we retain an LPN of 2 for this species. Yosemite toad ( *Bufo canorus* )—The following summary is based on information contained in our files and the petition we received on April 3, 2000. See also our 12-month petition finding published on December 10, 2002 (67 FR 75834). Yosemite toads are moderately sized toads with females having black spots, edged with white or cream, that are set against a grey, tan or brown background. Males have a nearly uniform coloration of yellow-green to olive drab to greenish brown. Yosemite toads are most likely to be found in areas with thick meadow vegetation or patches of low willows near or in water, and use rodent burrows for overwintering and temporary refuge during the summer. Breeding habitat includes the edges of wet meadows, slow flowing streams, shallow ponds and shallow areas of lakes. The historic range of Yosemite toads in the Sierra Nevada occurs from the Blue Lakes region north of Ebbetts Pass (Alpine County) to south of Kaiser Pass in the Evolution Lake/Darwin Canyon area (Fresno County). The historic elevational range of Yosemite toads is 1,460 to 3,630 m (4,790 to 11,910 ft). The threats currently facing the Yosemite toad include cattle grazing, timber harvesting, recreation, disease, and climate change. Inappropriate grazing has shown to cause loss of vegetative cover and destruction of peat layers in meadows, which lowers the groundwater table and summer flows. This may increase the stranding and mortality of tadpoles, or make these areas completely unsuitable for Yosemite toads. Grazing can also degrade or destroy moist upland areas used as non-breeding habitat by Yosemite toads and collapse rodent burrows used by Yosemite toads as cover and hibernation sites. Timber harvesting and associated road development could severely alter the terrestrial environment and result in the reduction and occasional extirpation of amphibian populations in the Sierra Nevada. These habitat gaps may act as dispersal barriers and contribute to the fragmentation of Yosemite toad habitat and populations. Trails (foot, horse, bicycle, or off-highway motor vehicle) compact soil in riparian habitat, which increases erosion, displaces vegetation, and can lower the water table. Trampling or the collapsing of rodent burrows by recreational users, pets, and vehicles could lead to direct mortality of all life stages of the Yosemite toad and disrupt their behavior. Various diseases have been confirmed in Yosemite toads. Mass die-offs of amphibians have been attributed to: Chytrid fungal infections of metamorphs and adults; *Saprolegnia* fungal infections of eggs; iridovirus infection of larvae, metamorphs, or adults; and bacterial infections. Yosemite toads probably are exposed to a variety of pesticides and other chemicals throughout their range. Environmental contaminants could negatively affect the species by causing direct mortality; suppressing the immune system; disrupting breeding behavior, fertilization, growth or development of young; and disrupting the ability to avoid predation. We retained an LPN of 11 for the Yosemite toad since the threats are nonimminent and moderate to low in magnitude. Black Warrior waterdog ( *Necturus alabamensis* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Fishes Headwater chub ( *Gila nigra* )—The following summary is based on information contained in our files and the 12-month finding on a petition to list the species we published May 3, 2006 (71 FR 26007). The range of the headwater chub has been reduced by approximately 50 to 60 percent. Approximately 16 streams (125 miles (200 kilometers) of stream) are thought to be occupied out of 19 streams (312 miles (500 kilometers) of stream) formerly occupied in the Gila River Basin in Arizona and New Mexico. Remaining populations are fragmented and isolated and threatened by a combination of factors. Headwater chub are threatened by introductions of nonnative fish that prey on them and/or compete with them for food. These nonnative fish are difficult to eliminate and, therefore, pose an on-going threat. Habitat destruction and modification has occurred and continues to occur as a result of dewatering, impoundment, channelization, and channel changes caused by alteration of riparian vegetation and watershed degradation from mining, grazing, roads, water pollution, urban and suburban development, groundwater pumping, and other human actions. Existing regulatory mechanisms do not appear to be adequate for addressing the impact of nonnative fish and also have not removed or eliminated the threats that continue to be posed in relation to habitat destruction or modification. The fragmented nature and rarity of existing populations makes them vulnerable to other natural or manmade factors, such as drought and wildfire. The Arizona Game and Fish Department has created the Arizona Statewide Conservation Agreement for Roundtail Chub ( *G. robusta* ), Headwater Chub, Flannelmouth Sucker ( *Catostomus latipinnis* ), Little Colorado River Sucker ( *Catostomus* spp.), Bluehead Sucker ( *C. discobolus* ), and Zuni Bluehead Sucker ( *C. discobolus yarrowi* ), which is in the process of being finalized. The New Mexico Department of Game and Fish recently listed the headwater chub as endangered and created a recovery plan for the species, Colorado River Basin Chubs (Roundtail Chub, Gila Chub ( *G. intermedia* ), and Headwater Chub) Recovery Plan, which was approved by the New Mexico State Game Commission on November 16, 2006. Both the Arizona Agreement and the New Mexico Recovery Plan recommend preservation and enhancement of extant populations and restoration of historical headwater chub populations. The recovery and conservation actions prescribed by Arizona and New Mexico plans, which we believe will reduce and remove threats to this species, will require further discussions and authorizations before they can be implemented. However, due to the ongoing high magnitude threats, including loss of habitat, degradation of remaining habitat, and others (e.g., nonnative species, drought, and fire), we maintain the current LPN of 2 for this species. Arkansas darter ( *Etheostoma cragini* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Arkansas darter is a small fish in the perch family native to portions of the Arkansas River basin. The species' range includes sites in extreme northwestern Arkansas, southwestern Missouri, and northeastern Oklahoma, within the Neosho River watershed. It also occurs in a number of watersheds and isolated streams in eastern Colorado, south-central and southwestern Kansas, and the Cimarron watershed in northwest Oklahoma. The species is most often found in small spring fed streams with sand substrate and aquatic vegetation. It appears stable at most sites where spring flows persist. It has declined in areas where spring flows have decreased or been eliminated. We estimate that currently there are approximately 145 occurrences of the Arkansas darter distributed across the five States; it was found at 29 of 67 sites sampled in 2005-2006. Major threats to the species include stream dewatering resulting from groundwater pumping in the western portion of the species' range, and development pressures in portions of its eastern range. Spills and runoff from confined animal feeding operations also potentially threaten the species range-wide. We are retaining an LPN of 11 for the Arkansas darter until we can assess more current information. Cumberland darter ( *Etheostoma susanae* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Although the Cumberland darter was once recorded as abundant, it is now considered to be rare and extremely restricted in range known from only 18 locations in streams in the upper Cumberland River system, above Cumberland Falls, in Kentucky and Tennessee. The species inhabits shallow water in pools and runs of headwater streams with stable sand, silt, or sand-covered bedrock substrata. The primary threat to the Cumberland darter is the siltation of instream habitats caused by coal mining activities, silvicultural practices, road construction, and urban development. The small size and range of Cumberland darter populations also make them much more susceptible to extirpation from single catastrophic events (such as toxic chemical spills) and reduces their ability to recover from smaller impacts to their habitat or populations. All surviving populations of the Cumberland darter are restricted to short stream reaches, with the majority believed to be restricted to less than one mile of stream. These occurrences are thought to form six population clusters, which are isolated from one another by poor quality habitat, impoundments, or natural barriers. Specific information on the threats to the current distribution of the Cumberland darter was initiated in May 2006 by the Kentucky Department of Fish and Wildlife Resources and additional sampling was completed in spring 2007 at approximately 10 to 15 sites in Kentucky and Tennessee. Collectively, these factors are serious and significant impediments to the survival of the Cumberland darter; thus these threats are high in magnitude. Federal and state water quality laws have reduced water quality threats to some degree, and non-point pollution threats and modification of reach geomorphology and hydrology are cumulative and gradual. Therefore, these factors are nonimminent. Consequently, we have assigned the Cumberland darter a listing priority of 5, reflecting a threat magnitude and immediacy of high and nonimminent, respectively. Pearl darter ( *Percina aurora* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Little is known about the specific habitat requirements or natural history of the Pearl darter. Pearl darters have been collected from a variety of river/stream attributes, mainly over gravel bottom substrate. This species is historically known only from localized sites within the Pascagoula and Pearl River drainages in two states. Currently, the Pearl darter is considered extirpated from the Pearl River drainage and rare in the Pascagoula River drainage. Since 1983, the range of the Pearl darter has decreased by 55 percent. Pearl darters are vulnerable to the cumulative impacts of a variety of non-point pollution sources, such as sedimentation and chemicals, and also to more localized and concentrated pollution events. The steady yet gradual change in river and tributary geomorphology and hydrology over time is believed to have an impact on this species. The magnitude of threat to this species is high due to their limited and disjunct populations and threat due to sedimentation. However, the immediacy of the threat is nonimminent since no known projects are planned that would have a direct impact on the species, and the decline of water quality is slow and gradual. In addition, efforts are underway to improve habitat by reducing these threats and to increase and augment the numbers of Pearl darters by husbandry. Therefore, we assign this species an LPN of 5. Rush darter ( *Etheostoma phytophilum* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Rush Darter is endemic to upland portions of the Black Warrior River system in Alabama where it occurs in shallow headwater streams. This species is uncommon and sporadic within its range, as it favors shallow, flowing water in spring runs and spring-associated streams with emergent vegetation. Only three disjunct populations are known: One in the Clear Creek system in Winston County, one in spring-fed tributaries of Turkey Creek in Jefferson County; and one population in Little Cove Creek (Cove Springs) in Etowah County. The Jefferson County population (Turkey Creek), which is located in a large metropolitan area, is threatened by urbanization and commercialization of its habitat. Siltation from bridge, road, and sewer line construction has been recently documented within the Turkey Creek watershed by academic researchers and Service biologists. The major threat to the Winston County population of rush darters is erosion of Mill Creek, Doe and Wildcat Branch, and the cumulative increase of sediments caused from gravel roads and roadside ditches. Within the past year, biologists have observed increased erosion along roads adjacent to Doe and wildcat Branches which resulted in increased siltation within those streams. Increases in urbanization, road maintenance and silviculture practices contribute to increased sedimentation in the watershed. The major threat to the Cove Springs population is contamination of the water with chlorine. Efforts are underway to improve habitat and water quality; however, at this time all populations are being negatively affected by declining water quality. The magnitude of threat is high due to the limited number of populations, and the threat is imminent because water quality is currently declining for all populations. Thus, we assigned an LPN of 2 to this species. Yellowcheek darter ( *Etheostoma moorei* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The yellowcheek darter is endemic to four headwater tributaries of the Little Red River. It is vulnerable to alterations in physical habitat characteristics such as the impoundment of Greers Ferry Reservoir, channel maintenance in the Archey Fork, increased sedimentation from eroding stream banks and poor riparian management, and illegal gravel mining. Factors affecting the remaining populations include loss of suitable breeding habitat, habitat and water quality degradation, population isolation, and severe population declines exacerbated by stochastic drought conditions. A 2004-2005 threats assessment by Service personnel documented occurrences of the aforementioned activities and found 52 sites on the Middle Fork, 28 sites on the South Fork, eight sites on Archey Fork, and one site in the Turkey/Beech/Devils Fork system that are potential contributors to the decline of the species. Since the threats assessment was completed, natural gas exploration and development in the Fayetteville Shale formation in north central Arkansas has also become a primary threat in all watersheds and is not addressed by the conservation agreements in place or by any regulatory mechanism. The Middle Fork was listed as an impaired waterbody by the Arkansas Department of Environmental Quality in 2004 due to excessive bacteria and low dissolved oxygen. Recent studies have documented significant declines in the numbers (60,000 in 1981; 10,300 in 2000) of this fish in the remaining populations and further range restriction within the tributaries (130.4 to 65.0 stream km). As a result, yellowcheek darter numbers had declined over a 20 year period by 83 percent in both the Middle Fork and South Fork, and 60 percent in the Archey Fork during a 2000 status survey. No yellowcheek darters have been found in the Turkey Fork between 1999 and 2005; the species has apparently been extirpated in that reach. Due to imminent threats of a high magnitude that are not currently targeted by conservation actions, we assigned this species an LPN of 2. Chucky madtom ( *Noturus crypticus* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Chucky madtom is a rare catfish known from only 15 specimens collected from two Tennessee streams. A lone individual was collected in 1940 from Dunn Creek (a Little Pigeon River tributary) in Sevier County and 14 specimens have been encountered since 1991 in Little Chucky Creek (a Nolichucky River tributary) in Greene County. Only 3 specimens have been encountered since 1994 from two riffle areas in a short reach of Little Chucky Creek. All Little Chucky Creek specimens have been collected from stream runs with slow to moderate current over pea gravel, cobble, or slab-rock substrates. Threats to the chucky madtom include both extrinsic and intrinsic factors. Extrinsic factors include potential degradation of water quality and breeding and sheltering habitat due primarily to agricultural land use practices and secondarily to urban and rural development in the watersheds of Little Chucky and Dunn creeks. The Service believes that intrinsic factors including the potential demographic effects of inbreeding, limited species distribution, presumed low number of individuals, and presumed low fecundity and short life span characteristic of closely related madtom species pose imminent threats to the chucky madtom in its only known extant and historic locations. Therefore, we assigned the chucky madtom an LPN of 2. Grotto sculpin ( *Cottus* sp., sp. nov.)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Grotto sculpin, a small fish, is restricted to two karst areas (limestone regions characterized by sink holes, abrupt ridges, caves, and underground streams), the Central Perryville Karst and Mystery-Rimstone Karst in Perry County, southeast Missouri. Grotto sculpins have been documented in only 5 caves. The current overall range of the grotto sculpin has been estimated to encompass approximately 260 square kilometers (100 square miles). The small population size and endemism of the grotto sculpin make it vulnerable to extinction due to genetic drift, inbreeding depression, and random or chance changes to the environment. The species' karst habitat is located down-gradient of the city of Perryville, Missouri, which poses a potential threat if contaminants from this urban area enter cave streams occupied by grotto sculpins. Various agricultural chemicals, such as ammonia, nitrite/nitrate, chloride, and potassium have been detected at levels high enough to be detrimental to aquatic life within the Perryville Karst area. More than half of the sinkholes in Perry County contain anthropogenic refuse, ranging from household cleansers and sewage to used pesticide and herbicide containers. As a result, potential water contamination from various sources of point and non-point pollution poses a significant threat to the grotto sculpin. Of the 5 cave systems documented to have grotto sculpins, populations in one cave system were likely eliminated, presumably as the result of point-source pollution. When the cave was searched in the spring of 2000, a mass mortality of grotto sculpin was noted, and subsequent visits to the cave have failed to document a single live grotto sculpin. Thus, the species appears to have suffered a 20 percent decrease in the number of populations from the single event. Predatory fish such as common carp, fat-head minnow, yellow bullhead, green sunfish, bluegill, and channel catfish occur in all of the caves occupied by grotto sculpin. These potential predators may escape surface farm ponds that unexpectedly drain through sinkholes into the underground cave systems and enter grotto sculpin habitat. No regulatory mechanisms are in place that would provide protection to the grotto sculpin. Current threats to the habitat of the grotto sculpin may exacerbate potential problems associated with its low population numbers and increase the likelihood of extinction. Due to the high magnitude of ongoing, and thus imminent, threats we assigned this species an LPN of 2. Sharpnose shiner ( *Notropis oxyrhynchus* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The sharpnose shiner is a small, slender minnow, endemic to the Brazos River Basin in Texas. Historically, the sharpnose shiner existed throughout the Brazos River and several of its major tributaries within the watershed. It has also been found in the Wichita River (within the Red River Basin) where it may have once naturally occurred but has since been extirpated. Current information indicates that the population within the Upper Brazos River drainage (upstream of Possum Kingdom Reservoir) is apparently stable, while the population within the Middle and Lower Brazos River Basins may only exist in remnant populations in areas of suitable habitat, which may no longer be viable, representing a reduction of approximately 68 percent of its historical range. The most significant threat to the existence of the sharpnose shiner is potential reservoir development within its current range. Additional threats include irrigation and water diversion, sedimentation, desalination, industrial and municipal discharges, agricultural activities, in-stream sand and gravel mining, and the spread of invasive saltcedar. The current limited distribution of the sharpnose shiner within the Upper Brazos River Basin makes it vulnerable to catastrophic events such as the introduction of competitive species or prolonged drought. State law does not provide protection for the sharpnose shiner. The magnitude of threat is considered high since the major threat of reservoir development within the species current range may render its remaining habitat unsuitable. The immediacy of threat is non-imminent because major reservoir projects are not likely to occur in the near future and there is potential for implementing other water supply options that could preclude reservoir development. For these reasons, we assign an LPN of 5 to this species. Smalleye shiner ( *Notropis buccula* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The smalleye shiner is a small, pallid minnow endemic to the Brazos River Basin in Texas. The population of smalleye shiners within the Upper Brazos River drainage (upstream of Possum Kingdom Reservoir) is apparently stable. However, the shiner has not been collected since 1976 downstream from the reservoir, and may be extirpated from this area, representing a reduction of approximately 54 percent of its historical range. The most significant threat to the existence of the smalleye shiner is potential reservoir development within its current range. Additional threats include irrigation and water diversion, sedimentation, desalination, industrial and municipal discharges, agricultural activities, in-stream sand and gravel mining, and the spread of invasive saltcedar. The current limited distribution of the smalleye shiner within the Upper Brazos River Basin makes it vulnerable to catastrophic events such as the introduction of competitive species or prolonged drought. State law does not provide protection for the smalleye shiner. The magnitude of threat is considered high since the major threat of reservoir development within the current range of the species may render its remaining habitat unsuitable. The immediacy of threat is considered non-imminent because major reservoir projects are not likely to occur in the near future and there is potential for implementing other water supply options that could preclude reservoir development. For these reasons, we assign an LPN of 5 to this species. Zuni bluehead sucker ( *Catostomus discobolus yarrowi* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The range of the Zuni bluehead sucker has been reduced by over 90 percent. The Zuni bluehead sucker currently occupies 9 river miles in 3 areas of New Mexico, and potentially occurs in 27 miles in the Kinlichee drainage of Arizona. However, the number of occupied miles in Arizona is unknown and the genetic composition of these fish is still under investigation. Zuni bluehead sucker range reduction and fragmentation is caused by discontinuous surface water flow, separation of inhabited reaches by reservoirs, and habitat degradation from fine sediment deposition. The principal uses of surface and ground water within the Zuni River watershed are human consumption, livestock, and irrigation. Diverting water for agricultural use is the primary purpose of at least five impoundments, and several other reservoirs act as flood-control structures. Degradation of the upper watershed has led to increased sedimentation, and many of the reservoirs are now only shallow, eutrophic (low oxygen) ponds or wetlands with little or no storage capacity. The impoundments have also changed the downstream channel morphology and substrate composition of streams. Another major impact to populations of Zuni bluehead sucker was the application of fish toxicants through at least two dozen treatments in the Nutria and Pescado rivers between 1960 and 1975. Large numbers of Zuni bluehead suckers were killed during these treatments. For several years, the New Mexico Department of Game and Fish has been the lead agency to develop a conservation plan for Zuni bluehead sucker. A study funded through section 6 of the Act was initiated in 2000 and has continued annually. The grant included funding for development and implementation of a Zuni Bluehead Sucker Conservation Plan and the acquisition of additional information on distribution, life history, and species associations. The Zuni Bluehead Sucker Recovery Plan was approved by the New Mexico State Game Commission during a State Game Commission meeting on December 15, 2004. The Recovery Plan recommends preservation and enhancement of extant populations and restoration of historical Zuni bluehead sucker populations. The recovery actions prescribed by the State Recovery Plan that we believe will reduce and remove threats to this subspecies will require further discussions and authorizations before they can be implemented. Because of the ongoing threats of high magnitude, including loss of habitat (historical and current from beaver activity), degradation of remaining habitat, drought, and fire, we maintain the current LPN of 3 for this subspecies. Clams Texas hornshell ( *Popenaias popei* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Texas hornshell is a freshwater mussel found in the Black River of New Mexico and one confirmed locality in the mainstem Rio Grande of Texas and Mexico. The primary threats are habitat alterations such as stream bank channelization, impoundments, and diversions for agriculture and flood control; contamination of water by the oil and gas industry; alterations in the natural riverine hydrology; and increased sedimentation from prolonged overgrazing and loss of native vegetation. Riverine habitats in both the Black River and the Rio Grande are under constant threats from these adverse changes. The magnitude of threats is high because of the existence of only one confirmed location in New Mexico and Texas each, which makes this species highly vulnerable to extinction. The threats are imminent because past alterations to riverine habitats have resulted in the much reduced distribution of this species and demands for water from the Rio Grande continue to increase and make additional habitat degradation likely. Thus, we maintain the LPN of 2 for this species. Fluted kidneyshell ( *Ptychobranchus subtentum* )—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Neosho mucket ( *Lampsilis rafinesqueana* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Neosho mucket is a freshwater mussel native to Arkansas, Kansas, Missouri, and Oklahoma. The species has been extirpated from approximately 62 percent (835 river miles) of its range, most of which has occurred in Kansas and Oklahoma. The Neosho mucket survives in four river drainages; however, only two of these, the Spring and Illinois Rivers, currently support relatively large populations. Significant portions of the historic range have been inundated by the construction of at least 11 dams. Channel instability downstream of these dams has further reduced suitable habitat and mussel distribution. Range restriction and population declines have occurred due to habitat degradation attributed to impoundments, mining, sedimentation, and agricultural pollutants. Rapid development and urbanization in the Illinois River watershed will likely continue to increase sedimentation and eutrophication to this river but populations are currently stable in this river. The remaining extant populations are vulnerable to random catastrophic events (e.g., flood scour, drought, toxic spills), land use changes within the limited range, and genetic isolation and the deleterious effects of inbreeding. These threats have led to the species being intrinsically vulnerable to extirpation. Although State regulations limit harvest of this species, there is little protection for habitat. The threats are high in magnitude as they can negatively affect the species throughout its range and result in mortality and/or reduced reproductive output. While some of the threats are ongoing and thus, imminent, others are nonimminent, but on balance, the threats are nonimminent. Thus, we assigned an LPN of 5 to this species. Alabama pearlshell ( *Margaritifera marrianae* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Alabama pearlshell ( *Margaritifera marrianae* ) inhabits shallow riffles and pool margins of small creeks and streams of southwest Alabama. Only three populations of Alabama pearlshell have been confirmed to survive during the past 15 years. A comprehensive survey is planned by the Alabama Department of Conservation and Natural Resources in 2007. One of the three populations has declined significantly over the past few years, apparently due to increased sedimentation at this location and possibly other forms of non-point source

(NPS)pollution. The other two populations also appear to be declining. The Alabama pearlshell has been assigned a listing priority of 2 because the NPS pollution is ongoing, and therefore imminent, and the vulnerability of small stream habitat to continuing NPS pollution, combined with the fewer numbers of live mussels in the three known populations, means that the NPS pollution poses a high-magnitude threat to this species. Slabside pearlymussel ( *Lexingtonia dolabelloides* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The slabside pearlymussel is a freshwater mussel (Unionidae) endemic to the Cumberland and Tennessee River systems (Cumberlandian Region) in Alabama, Kentucky, Tennessee, and Virginia. It requires shoal habitats in free-flowing rivers to survive and successfully recruit new individuals into its populations. Habitat destruction and alteration (e.g., impoundments, sedimentation, and pollutants) are the chief factors contributing to its decline. This species has been extirpated from numerous regional streams and is no longer found in the Commonwealth of Kentucky. The slabside pearlymussel was historically known from at least 32 streams but is currently restricted to no more than 10 isolated stream segments. Current status information for most of the 10 populations deemed to be extant is available from recent periodic sampling efforts (sometimes annually) and other field studies. Comprehensive surveys have taken place in the Middle and North Forks Holston River, Paint Rock River, and Duck River in the past several years. Based on recent information, the overall population of the slabside pearlymussel is declining rangewide. Of the five streams in which the species remains in good numbers and is clearly viable (e.g., Clinch, North and Middle Forks Holston, Paint Rock, Duck Rivers), the Middle and upper North Fork Holston Rivers have undergone drastic recent declines, while the Clinch population has been in a longer-term decline. Most of the remaining five populations (e.g., Powell River, Big Moccasin Creek, Hiwassee River, Elk River, Bear Creek) have doubtful viability and several if not all of them may be on the verge of extirpation. Since most of the populations of slabside pearlymussel are declining and face potential threats from impoundments, sedimentation, small population size, isolation of populations, gravel mining, municipal pollutants, agricultural run-off, nutrient enrichment, and coal processing pollution, the threats are high in magnitude. However, there is no specific information regarding the timing of these threats, so we do not consider them to be imminent. Thus, we continue to assign an LPN of 5 to this mussel. Georgia pigtoe ( *Pleurobema hanleyanum* )—We have not updated our candidate assessment for this species as we are currently developing a proposed listing rule. Altamaha spinymussel ( *Elliptio spinosa* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Altamaha spinymussel is a freshwater mussel endemic to the Altamaha River drainage of southeastern Georgia. The historical range of the Altamaha spinymussel was restricted to the Coastal Plain portion of the Altamaha River and the lower portions of its three major tributaries, the Ohoopee, Ocmulgee, and Oconee Rivers. The Altamaha spinymussel is associated with stable, coarse to fine sandy sediments of sandbars and sloughs and appears to be restricted to swiftly flowing water. As the name implies, the shells of these animals are adorned with one to five prominent spines that reach lengths from 10 to 25 mm (0.39 to 0.98 in). The species appears to be extirpated from the Ohoopee and Oconee Rivers, and its numbers are greatly reduced in the Ocmulgee and Altamaha Rivers. Altamaha spinymussels face severe habitat degradation from a number of sources. Primary among these are threats from sedimentation and contaminants within the rivers that the Altamaha spinymussel inhabits. A new threat of deadhead logging has recently emerged. These threats to the Altamaha spinymussel are further compounded by its limited distribution and the low population size identified in recent survey efforts. Efforts to identify the host fish and expand our understanding of the spinymussels life cycle have not yet produced results. Since the threats are ongoing (i.e., imminent) and severely affect this species throughout its range (i.e., high in magnitude), we continue to assign an LPN of 2 to this species. Snails Ogden mountainsnail ( *Oreohelix peripherica wasatchensis* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Ogden mountain snail is known from a single population near the mouth of Ogden Canyon, Weber County, Utah. The total occupied habitat is an area approximating 100 meters (328 ft) wide by 1 kilometer (0.5 miles) long. The restricted range of this snail, the proximity to an expanding residential area, and impacts from relatively heavy recreational use, makes it vulnerable to extirpation from stochastic or human-caused events. Threats to the colony have not changed or increased substantially over the past year. Recent molecular phylogenic studies are expected to clarify the level of uniqueness of this taxon. The ongoing (i.e. imminent) threats are moderately affecting the species. Therefore, we retained an LPN of 9 for this subspecies. Fat-whorled (Bonneville) pondsnail ( *Stagnicola bonnevillensis* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The fat-whorled pondsnail, also known as the Bonneville pondsnail, occupies four spring pools north of the Great Salt Lake in Box Elder County, Utah. While the number of individuals is unknown, the total known occupied habitat is less than one hectare. Previous and ongoing threats include chemical contamination of the groundwater. Significant actions are underway to remediate this threat, including implementation of a Corrective Action Plan to characterize and remediate groundwater contamination, implementation of a site management plan, and development of a groundwater model and risk assessment. These efforts have not been underway for a sufficient period to reduce the threat from contamination. While contamination continues to occur, and therefore, the threat is imminent, the levels of contamination are such that it affects the species over a longer timeframe, so the threat is moderate in magnitude. Therefore, we retained an LPN of 8 for this species. Interrupted rocksnail ( *Leptoxis foremani* (= *downei* )—We have not updated our candidate assessment as we are currently developing a proposed listing rule for this species. Sisi snail ( *Ostodes strigatus* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The sisi snail is a ground-dwelling species in the Potaridae family and is endemic to American Samoa. The species is now known from a single population on the island of Tutuila, American Samoa. This species is currently threatened by habitat loss and modification and by predation from nonnative predatory snails. The decline of the sisi in American Samoa has resulted, in part, from loss of habitat to forestry and agriculture and loss of forest structure to hurricanes and alien weeds that establish after these storms. All live sisi snails have been found in the leaf litter beneath remaining intact forest canopy. No snails were found in areas bordering agricultural plots or in forest areas that were severely damaged by three hurricanes (1987, 1990, and 1991). Under natural historic conditions, loss of forest canopy to storms did not pose a great threat to the long term survival of these snails; enough intact forest with healthy populations of snails would support dispersal back into newly regrown canopy forest. However, the presence of alien weeds such as mile-a-minute vine ( *Mikania micrantha* ) may reduce the likelihood that native forest will re-establish in areas damaged by the hurricanes. This loss of habitat to storms is greatly exacerbated by expanding agriculture. Agricultural plots on Tutuila have spread from low elevation up to middle and some high elevations, greatly reducing the forest area and thus reducing the resilience of native forests and its populations of native snails. These reductions also increase the likelihood that future storms will lead to the extinction of populations or species that rely on the remaining canopy forest. In an effort to eradicate the giant African snail ( *Achatina fulica* ), the alien rosy carnivore snail ( *Euglandia rosea* ) was introduced in 1980. The rosy carnivore snail has spread throughout the main island of Tutuila. Numerous studies show that the rosy carnivore snail feeds on endemic island snails including the sisi, and is a major agent in their declines and extirpations. At present, the major threat to long-term survival of the native snail fauna in American Samoa is predation by nonnative predatory snails. These threats are ongoing and are therefore imminent. Since the threats occur throughout the entire range of the species and have a significant effect on the survival of the snails, they are of a high magnitude. Therefore we assigned this species an LPN of 2. Diamond Y Spring snail ( *Pseudotryonia adamantina* ) and Gonzales springsnail ( *Tryonia circumstriata* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Diamond Y Spring snail and Gonzales springsnail are small aquatic snails endemic to Diamond Y Spring in Pecos County, Texas. The spring and its outflow channel are owned and managed by The Nature Conservancy. These snails are primarily threatened with habitat loss due to springflow declines from drought and from pumping of groundwater. Additional threats include water contamination from accidental releases of petroleum products, as their habitat is in an active oil and gas field. Also, a nonnative aquatic snail ( *Melanoides* sp.) was recently introduced into the native snails' habitat and may compete with endemic snails for space and resources. The magnitude of threats is high because limited distribution of these narrow endemics makes any impact from increasing threats (e.g., loss of springflow, contaminants, and nonnative species) likely to result in the extinction of the species. These species occur in one location in an arid region currently plagued by drought and ongoing aquifer withdrawals, making the threat to spring flow imminent. Thus, we maintain the LPN of 2 for both species. Fragile tree snail ( *Samoana fragilis* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, the fragile tree snail is a member of the Partulidae family of snails and is endemic to the islands of Guam and Rota (Mariana Islands). Requiring cool and shaded native forest habitat, the species is now known from 4 populations on Guam and a single population on Rota. This species is currently threatened by habitat loss and modification and by predation from nonnative predatory snails and flatworms. Large numbers of deer ( *Cervus marianuns* ) (Guam and Rota), pigs ( *Sus scrofra* ) (Guam), water buffalo ( *Bubalus bubalis* ) (Guam), and cattle ( *Bos taurus* ) (Rota), directly alter the understory plant community and overall forest microclimate making it unsuitable for snails. Predation by the alien rosy carnivore snail ( *Euglandina rosea* ) and the Manokwar flatworm ( *Platydemus manokwari* ) is a serious threat to the survival of the fragile tree snail. Field observations have established that the rosy carnivore snail and the Manokwar flatworm will readily feed on native Pacific island tree snails, including the Partulidae, such as those of the Mariana Islands. The rosy carnivore snail has caused the extirpation of many populations and species of native snails throughout the Pacific islands. Because all of the threats occur rangewide and have a significant effect on the survival of this snail species, they are high in magnitude. The threats are also ongoing and thus, are imminent. Therefore, we assigned this species an LPN of 2. Guam tree snail ( *Partula radiolata* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, the Guam tree snail is a member of the Partulidae family of snails and is endemic to the island of Guam. Requiring cool and shaded native forest habitat, the species is now known from 22 populations on Guam. This species is primarily threatened by predation from nonnative predatory snails and flatworms. In addition, the species is also threatened by habitat loss and degradation. Predation by the alien rosy carnivore snail ( *Euglandina rosea* ) and the alien Manokwar flatworm ( *Platydemus manokwari* ) is a serious threat to the survival of the Guam tree snail. Field observations have established that the rosy carnivore snail will readily feed on native Pacific island tree snails, including the Partulidae, such as those of the Mariana Islands. The rosy carnivore snail has caused the extirpation of many populations and species of native snails throughout the Pacific islands. The Manokwar flatworm has also contributed to the decline of native tree snails, in part due to its ability to ascend into trees and bushes that support native snails. Areas with populations of the flatworm usually lack partulid tree snails or have declining numbers of snails. On Guam, open agricultural fields and other areas prone to erosion were seeded with tangantangan ( *Leucaena leucocephala* ) by the U.S. Military. Tangantangan grows as a single species stand with no substantial understory. The microclimatic condition is dry with little accumulation of leaf litter humus and is particularly unsuitable as Guam tree snail habitat. In addition, native forest cannot reestablish and grow where this alien weed has become established. Because all of the threats occur rangewide and have a significant effect on the survival of this snail species, they are high in magnitude. The threats are also ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Humped tree snail ( *Partula gibba* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, the humped tree snail is a member of the Partulidae family of snails, and was originally known from the island of Guam and the Commonwealth of the Northern Mariana Islands (islands of Rota, Aguiguan, Tinian, Saipan, Anatahan, Sarigan, Alamagan, and Pagan). Most recent surveys revealed a total of 14 populations on the islands of Guam, Rota, Aguiguan, Sarigan, Saipan, Alamagan, and Pagan. Although still the most widely distributed tree snail endemic in the Mariana Islands, remaining population sizes are often small. This species is currently threatened by habitat loss and modification and by predation from nonnative predatory snails and flat worms. Throughout the Mariana Islands, feral ungulates (pigs ( *Sus scrofa* ), Philippine deer ( *Cervus mariannus* ), cattle ( *Bos taurus* ), water buffalo ( *Bubalus bubalis* ), and goats ( *Capra hircus* )) have caused severe damage to native forest vegetation by browsing directly on plants, causing erosion, and retarding forest growth and regeneration. This in turn reduces the quantity and quality of forested habitat for the humped tree snail. Currently, populations of feral ungulates are found on the islands of Guam (deer, pigs, and water buffalo), Rota (deer and cattle), Aguiguan (goats), Saipan (deer, pigs, and cattle), Alamagan (goats, pigs, and cattle), and Pagan (cattle, goats, and pigs). Goats were eradicated from Sarigan in 1998 and the humped tree snail has increased in abundance on that island, likely in response to the removal of all the goats. However, the population of humped tree snails on Anatahan is likely extirpated due to the massive volcanic explosions of the island beginning in 2003 and still continuing, and the resulting loss of up to 95 percent of the vegetation on the island. Predation by the alien rosy carnivore snail ( *Euglandina rosea* ) and the alien Manokwar flatworm ( *Platydemus manokwari* ) is a serious threat to the survival of the humped tree snail. Field observations have established that the rosy carnivore snail will readily feed on native Pacific island tree snails, including the Partulidae, such as those of the Mariana Islands. The rosy carnivore snail has caused the extirpation of many populations and species of native snails throughout the Pacific islands. The Manokwar flatworm has also contributed to the decline of native tree snails, in part due to its ability to ascend into trees and bushes that support native snails. Areas with populations of the flatworm usually lack partulid tree snails or have declining numbers of snails. The magnitude of threats is high because they cause significant population declines to the humped tree snail rangewide. These threats are ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Lanai tree snail ( *Partulina semicarinata* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, *P. semicarinata* is a member of the Achatinellidae family of snails. Endemic to the island of Lanai, the species is currently known from 3 populations totaling 29 individuals. This species is highly threatened throughout its limited range by habitat loss and modification and by predation from rats. No efforts are being undertaken to remove rats in areas where *P. semicarinata* occur. The threat from this predator is expected to continue or increase unless the rats are actively controlled or eradicated. Habitat loss also continues as nonnative ungulates trample and browse native vegetation required by *P. semicarinata* . Although the snails are in an area to be fenced, until the fence is completed and the ungulates have been removed, the habitat will continue to be degraded. The small number of individuals and the small number of populations make this species very susceptible to the negative effects of stochastic events such as hurricanes and storms. There is a population in captivity that is protected from the effects of unexpected droughts, though the effects of severe storms may still affect this population as evidenced by the loss of snails when a severe flood interrupted the power supply to the Hawaii Endangered Snail Captive Propagation Lab and temperatures increased within the environmental chambers containing the snails. In addition, these snails are likely subjected to the same concerns of reproductive vigor and loss of genetic variability. The magnitude of threats is high because they cause significant population declines to *P. semicarinata* rangewide. The threats are also ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Lanai tree snail ( *Partulina variabilis* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, *P. variabilis* is a member of the Achatinellidae family of snails. Endemic to the island of Lanai, the species is currently known from 12 populations totaling 90 individuals. This species is highly threatened throughout its limited range by habitat loss and modification and by predation from rats. The threat from this predator is expected to continue or increase unless the rats are actively controlled or eradicated. Habitat loss also continues as nonnative ungulates trample and browse native vegetation required by *P. variabilis* . Although the snails are in an area to be fenced, until the fence is constructed and the ungulates have been removed, the habitat will continue to be degraded. The small number of individuals and the small number of populations make this species very susceptible to the negative effects of stochastic events such as hurricanes and storms. There is a population in captivity that is protected from the effects of unexpected droughts, though the effects of severe storms may still affect this population as evidenced by the loss of snails when a severe flood interrupted the power supply to the University and temperatures increased within the environmental chambers containing the snails. In addition, these snails are likely subjected to the same concerns of reproductive vigor and loss of genetic variability as the wild population. The magnitude of threats is high because they result in direct mortality or significant population declines to *P. variabilis* rangewide. The threats are ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Langford's tree snail ( *Partula langfordi* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, Langford's tree snail is a member of the Partulidae family of snails and is known from one population on the island of Aguiguan. This species is currently threatened by habitat loss and modification and by predation from nonnative predatory snails. In the 1930s, the island of Aguiguan was mostly cleared of native forest to support sugar cane and pineapple production. The abandoned fields and airstrip are now overgrown with alien weeds. The remaining native forest understory has greatly suffered from large and uncontrolled populations of alien goats and the invasion of weeds. Goats ( *Capra hircus* ) have caused severe damage to native forest vegetation by browsing directly on plants, causing erosion, and retarding forest growth and regeneration. This in turn reduces the quantity and quality of forested habitat for Langford's tree snail. Predation by the alien rosy carnivore snail ( *Euglandina rosea* ) is also a serious threat to the survival of Langford's tree snail. Field observations have established that the rosy carnivore snail will readily feed on native Pacific island tree snails, including the Partulidae such as those of the Mariana Islands. The rosy carnivore snail has caused the extirpation of many populations and species of native snails throughout the Pacific islands. Predation on native partulid tree snails by the terrestrial Manokwar flatworm ( *Platydemus manokwari* ) is also a threat to the long-term survival of these snails. The Manokwar flatworm has contributed to the decline of native tree snails, due to its ability to ascend into trees and bushes that support native snails. Areas with populations of the flatworm usually lack partulid tree snails or have declining numbers of snails. All of the threats are occurring rangewide and no efforts to control or eradicate the nonnative predatory snail species or to reduce habitat loss are being undertaken. The magnitude of threats is high because they result in direct mortality or significant population declines to Langford's tree snail rangewide. These threats are also ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Newcomb's tree snail ( *Newcombia cumingi* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The species is endemic to the island of Maui, where it is currently known from a single remaining population. The greatest threats to Newcomb's tree snail are the loss of the only known remaining population due to predation from rats and the rosy carnivore snail ( *Euglandina rosea* ). There are no efforts in place to reduce the threat from the rosy carnivore snail although discussions are underway with the private landowner to construct a rat proof fence in the area occupied by this snail. Our attempts to raise this species in a captive propagation facility have been unsuccessful. The magnitude of threats is high because they occur within the last known population of the species and result in direct mortality or significant population declines. These threats are also ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Phantom Cave snail ( *Cochliopa texana* ) and Phantom springsnail ( *Tryonia cheatumi* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Phantom Cave snail and Phantom springsnail are small aquatic snails that occur in three spring outflows in the Toyah Basin in Reeves and Jeff Davis counties, Texas. The primary threat to both species is the loss of surface flows due to declining groundwater levels from drought and pumping for agricultural production. Although much of the land immediately surrounding their habitat is owned and managed by The Nature Conservancy, Bureau of Reclamation, and Texas Parks and Wildlife Department, the water needed to maintain their habitat has declined due to a reduction in spring flows, possibly as a result of private groundwater pumping in areas beyond that controlled by these landowners. As an example, Phantom Lake Spring, one of the sites of occurrence, has already ceased flowing and aquatic habitat is supported only by a pumping system. The magnitude of the threats is high because spring flow loss would result in complete habitat destruction and permanent elimination of all populations of the species. The immediacy of the threats is imminent, as evidenced by the drastic decline in spring flow at Phantom Lake Spring that is happening now and may extirpate these populations in the near future. Declining spring flows in San Solomon Spring are also becoming evident and will affect that spring site as well within the foreseeable future. Thus, we maintain the LPN of 2 for both species. Tutuila tree snail ( *Eua zebrina* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. A tree-dwelling species, the Tutuila tree snail is a member of the Partulidae family of snails and is endemic to American Samoa. The species is known from 32 populations on the islands of Tutuila, Nuusetoga, and Ofu. This species is currently threatened by habitat loss and modification and by predation from nonnative predatory snails and rats. All live Tutuila tree snails were found on understory vegetation beneath remaining intact forest canopy. No snails were found in areas bordering agricultural plots or in forest areas that were severely damaged by three hurricanes (1987, 1990, and 1991). Under natural historical conditions, loss of forest canopy to storms did not pose a great threat to the long-term survival of these snails; enough intact forest with healthy populations of snails would support dispersal back into newly regrown canopy forest. However, the presence of alien weeds such as mile-a-minute vine ( *Mikania micrantha* ) may reduce the likelihood that native forest will re-establish in areas damaged by the hurricanes. This loss of habitat to storms is greatly exacerbated by an expanding agricultural footprint. Agricultural plots on Tutuila have spread from low elevation up to middle and some high elevations, greatly reducing the forest area and thus reducing the resilience of native forests and its populations of native snails. In an effort to eradicate the giant African snail (Achatina fulica), the rosy carnivore snail ( *Euglandina rosea* ) was introduced in 1980 and has spread throughout the main island of Tutuila. Numerous studies show that the rosy carnivore snail feeds on endemic island snails, including the Tutuila snail, and is a major agent in their declines and extirpations. Rats ( *Rattus* spp) have also been shown to devastate snail populations and rat-chewed snail shells have been found at sites where the Tutuila snail occurs. At present, the major threat to the long-term survival of the native snail fauna in American Samoa is predation by nonnative predatory snails and rats. The magnitude of threats is high because they result in direct mortality or significant population declines to the Tutuila tree snail rangewide. The threats are also ongoing and thus are imminent. Therefore, we assigned this species an LPN of 2. Chupadera springsnail ( *Pyrgulopsis chupaderae* )—The following summary is based on information contained in our files and the petition we received on November 20, 1985. See also our 12-month petition finding published on October 4, 1988 (53 FR 38969). This aquatic species is endemic to Willow Spring on the Willow Spring Ranch (formerly Cienega Ranch) at the south end of the Chupadera Mountains in Socorro County, New Mexico. The Chupadera springsnail has been documented from two springs that flow through gravels containing sand, mud, and hydrophytic plants. Regional and local groundwater depletion, springrun dewatering, and riparian habitat degradation from livestock grazing represent the principal threats. The survival and recovery of the Chupadera springsnail is contingent upon protection of the riparian corridor immediately adjacent to Willow Spring and the availability of perennial, oxygenated flowing water within the species' thermal range. Due to several factors, including the extremely localized distribution of the snail, its occurrence only on private property, the lack of regulatory protection of its habitat, and the inability of land managers to participate in its management, the threats can cause significant population declines of the Chupadera springsnail. Therefore, the magnitude of the threats to this species is high. There is an imminent threat to this species because the threats are ongoing (e.g., grazing of cattle, water withdrawal, and fire). Due to the continuing high magnitude and imminence of threats to this species, we retain an LPN of 2 for this species. Elongate mud meadows springsnail ( *Pyrgulopsis notidicola* )—The following summary is based on information contained in our files. No new information was provided in the petition received on May 11, 2004. *Pyrgulopsis notidicola* is endemic to Soldier Meadow, which is located at the northern extreme of the western arm of the Black Rock Desert in the transition zone between the Basin and Range Physiographic Province and the Columbia Plateau Province, Humboldt County, Nevada. The type locality, and the only known location of the species, occurs in a stretch of thermal [between 45° Celsius

(C)(113° Fahrenheit (F)) and 32° C (90° F)] aquatic habitat that is approximately 300 m (984 ft) long and 2 m (6.7 ft) wide. *Pyrgulopsis notidicola* occurs only in shallow, flowing water on gravel substrate. The species does not occur in deep water (i.e. impoundments) where water velocity is low, gravel substrate is absent, and sediment levels are high. The present or threatened destruction, modification, or curtailment of its habitat or range by recreational bathers in the thermal waters is the greatest threat to the species. The small size of their habitat and their limited range makes them highly susceptible to any factors that negatively affect their habitat. A Recreational Management Plan was established in 2004 and several actions have been implemented, but no monitoring has taken place to evaluate the effectiveness of these actions on removing the threats to the species. Based on imminent threats of high magnitude, we assigned an LPN of 2 for this species. Gila springsnail ( *Pyrgulopsis gilae* )—The following summary is based on information contained in our files and the petition we received on November 20, 1985. Also see our 12-month petition finding published on October 4, 1988 (53 FR 38969). The Gila springsnail is an aquatic species known from 13 populations in New Mexico. The long-term persistence of the Gila springsnail is contingent upon protection of the riparian corridor immediately adjacent to springhead and springrun habitats. Sites on both private and Federal lands are subject to levels of recreational use and livestock grazing that negatively affect this species, thus placing the long-term survival of the Gila springsnail at risk. Natural events such as drought, forest fire, sedimentation, and flooding; wetland habitat degradation by recreational bathing in thermal springs; and poor watershed management practices represent the primary threats to the Gila springsnail. Fire suppression activities and fire retardant chemicals have potentially deleterious effects on this species. Because several of the springs occur on U.S. Forest Service land, management options for the protection of the snail should be possible. However, randomly occurring events, especially fire and drought, could have a major impact on the species. Moderate use by recreationalists and livestock is ongoing. If these uses remain at current or lower levels, they will not pose an imminent threat to the species. Of greater concern is drought, which could affect spring discharge and increases the potential for fire. Although the effect global climate change may have on streams and forests of the Southwest is unpredictable, mean annual temperature in New Mexico has increased by 0.6 degrees per decade since 1970. Higher temperatures lead to higher evaporation rates which may reduce the amount of runoff and groundwater recharge. Increased temperatures may also increase the extent of area influenced by drought and fire. Large fires have occurred in the Gila National Forest and subsequent floods and ash flows have severely affected aquatic life in streams. If the drought continues or worsens, the imminence of threats from decreased discharge or fire will increase. Based on these nonimminent threats that are currently of a low magnitude, we retain an LPN of 11 for this species. Gonzales springsnail ( *Tryonia circumstriata* )—See paragraph above under Diamond Y Spring snail ( *Pseudotryonia adamantina* ). Huachuca springsnail ( *Pyrgulopsis thompsoni* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above is based on information from our files. No new information was provided in the petition we received on May 11, 2004. New Mexico springsnail ( *Pyrgulopsis thermalis* )—The following summary is based on information contained in our files and the petition received on November 20, 1985. Also see our 12-month petition finding published on October 4, 1988 (53 FR 38969). The New Mexico springsnail is an aquatic species known from only two separate populations associated with a series of spring-brook systems along the Gila River in the Gila National Forest in Grant County, New Mexico. The long-term persistence of the New Mexico springsnail is contingent upon protection of the riparian corridor immediately adjacent to springhead and springrun habitats. Although the New Mexico springsnail populations may be stable, the sites inhabited by the species are subject to levels of recreational use and livestock grazing that can negatively affect this species. Moderate use by recreationalists and livestock is ongoing. If these uses remain at the current or lower levels, they will not pose an imminent threat to the species. Of greater concern is drought, which could affect spring discharge and increases the potential for fire. Although the effect global climate change may have on streams and forests of the Southwest is unpredictable, mean annual temperature in New Mexico has increased by 0.6 degrees per decade since 1970. Higher temperatures lead to higher evaporation rates which may reduce the amount of runoff and groundwater recharge. Increased temperatures may also increase the extent of area influenced by drought and fire. Large fires have occurred in the Gila National Forest and subsequent floods and ash flows have severely affected aquatic life in streams. If the drought continues or worsens, the imminence of threats from decreased discharge and fire will increase. Based on these nonimminent threats of a low magnitude, we retain an LPN of 11 for this springsnail. Page springsnail ( *Pyrgulopsis morrisoni* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information from our files. No new information was provided in the petition received on May 11, 2004. Three Forks springsnail ( *Pyrgulopsis trivialis* )—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Three Forks springsnail is an endemic species with distribution limited to the Three Forks Springs and Boneyard Springs spring complexes in the North Fork East Fork Black River Watershed of east-central Arizona. The springsnail was known from free-flowing spring heads, concrete boxed spring heads, spring runs, and spring seepage at these sites. The primary threats include habitat modification from recreational activities, damage from elk wallowing, and predation from nonnative crayfish. The population at Three Forks appears to be nearly extirpated following a fire retardant drop in 2004. The Arizona Game and Fish Department currently maintains an active monitoring program for the Three Forks springsnail in cooperation with the Service and U.S. Forest Service. This program includes population monitoring, habitat sampling, and removal of nonnative predatory crayfish. However, in the absence of a comprehensive management strategy to effectively address the threat from elk, crayfish, and fire suppression in the long-term, the threats are ongoing and therefore, imminent. The magnitude of threats is high, because limited distribution of this narrow endemic makes any impact from the threats likely to result in the extinction of the species. Therefore, we retain an LPN of 2 for the Three Forks springsnail. Insects Wekiu bug ( *Nysius wekiuicola* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The wekiu bug belongs to the true bug family, Lygaeidae, and is endemic to the island of Hawaii. This species only occurs on the summit of Mauna Kea and feeds upon other insect species which are blown to the summit of this large volcano. The wekiu bug is primarily threatened by the loss of its habitat from astronomy development. In 2004 and early 2005, surveys were conducted that found multiple new locations of the wekiu bug on the Mauna Kea summit. Several of these cinder cones within the Mauna Kea Science Reserve, as well as two other cinder cones located in the State Ice Age Natural Area Reserve, are not currently undergoing development nor is development planned. With the discovery of these new locations, the threats, though ongoing, do not occur across the entire range of the wekiu bug. The immediacy of the threats is imminent in some parts of the wekiu bug's range because ongoing development is occurring. Although the threats are ongoing and therefore imminent in some areas of wekiu bug habitat, the recent discoveries of new locations of the wekiu bug in areas that are not subject to the primary threat of astronomy development reduces the magnitude of the threat from high to moderate. Therefore, we assigned this species an LPN of 8. Mariana eight spot butterfly ( *Hypolimnas octucula mariannensis* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Mariana eight spot butterfly is a nymphalid butterfly species that feeds upon two host plants, *Procris pedunculata* and *Elatostema calcareum.* Endemic to the islands of Guam and Saipan, the species is now known from ten populations on Guam. This species is currently threatened by predation and parasitism. The Mariana eight spot butterfly has extremely high mortality of eggs and larvae due to predation by alien ants and wasps. Because the threat of parasitism and predation by nonnative insects occur range-wide and can cause significant population declines to this species, they are high in magnitude. The threats are imminent because they are ongoing. Therefore, we assigned an LPN of 3 for this subspecies. Mariana wandering butterfly ( *Vagrans egestina* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Mariana wandering butterfly is a nymphalid butterfly species which feeds upon a single host plant species, *Maytenus thompsonii.* Originally known from and endemic to the islands of Guam and Rota, the species is now known from one population on Rota. This species is currently threatened by alien predation and parasitism. The Mariana wandering butterfly is likely predated on by alien ants and parasitized by native and nonnative parasitoids. Because the threat of parasitism and predation by nonnative insects occur range-wide and can cause significant population declines to this species, they are high in magnitude. These threats are imminent because they are ongoing. Therefore, we assigned an LPN of 2 for this species. Miami blue butterfly ( *Cyclargus thomasi bethunebakeri* )—The following summary is based on information contained in our files and in the petition we received on June 15, 2000. The Miami blue is endemic to south Florida. Historically, it occurred throughout the Florida Keys, north to Hillsborough and Volusia Counties. None were reported to be found between 1996 and 1999, but it is presently located at two sites in the Keys. In 1999, a population was discovered at Bahia Honda State Park on Bahia Honda Key and in 2006 a second population was discovered on the outer islands of Key West National Wildlife Refuge. The former appears restricted to several 100 individuals at most, while the latter likely includes at least 1,500 individuals. Capacity to expand at either site or successfully emigrate from either site appears to be very low due to the sedentary nature of the butterfly and isolation of habitats. The actual area of occupied habitat has not yet been defined. Captive propagation and reintroduction efforts are continuing with some success. The Miami blue is predominantly a coastal species, occurring in disturbed and early successional habitats such as the edges of tropical hardwood hammock, coastal berm forest, and along trails and other open sunny areas, and historically in pine rocklands. These habitats provide larval host plants and adult nectar sources that are required to occur in close proximity. The magnitude of threat is high for this species, due to interacting risks associated with limited population size and range (and loss of historical range), hurricanes, and mosquito control activities. In addition, illegal collection may also pose a threat. Except for hurricanes, the threats are nonimminent because the current range is within a State park and National Wildlife Refuge, wherein the above threats are substantially controlled. Therefore, the Miami blue is assigned an LPN of 6. Sequatchie caddisfly ( *Glyphopsyche sequatchie* )—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Sequatchie caddisfly is known from two spring runs that emerge from caves in Marion County, Tennessee—Owen Spring Branch and Martin Spring run in the Battle Creek system. The Owen Spring Branch population occurs within Sequatchie Cave Park, which is a Class II Natural-Scientific State Natural Area, thus providing statutory protection from collection for the population in Owen Spring Branch. In spite of greater amounts of suitable habitat at the Martin Spring run, Sequatchie caddisflies are more difficult to find at this site. Biologists estimated population sizes at 500 to 5000 individuals for Owen Spring Branch and 2 to 10 times higher at Martin Spring, due to the greater amount of apparently suitable habitat. More recently, Dr. David Etnier reported that the Sequatchie caddisfly was abundant at the Owens Spring Branch location during observations in 2001, while only two individuals were observed at the Martin Spring locale. The primary threats to Sequatchie caddisfly include its extremely limited distribution, apparent small population size, the limited amount of occupied habitat, and the ease of accessibility. These threats are gradual and/or not necessarily imminent but are of a high magnitude; therefore, we assigned this species an LPN of 5. Clifton cave beetle ( *Pseudanophthalmus caecus* )—The following summary is based upon information in our files. No new information was provided in the petition we received on May 11, 2004. Clifton cave beetle is a small, eyeless, reddish-brown predatory insect that feeds upon small cave invertebrates. It is cave dependent and is not found outside the cave environment. Clifton cave beetle is only known from two privately owned Kentucky caves. Soon after the species was first collected in 1963, the entrance to the cave was enclosed due to road construction. Other caves in the vicinity of this cave were surveyed for the species during 1995-1996. Only one additional site was found to support the Clifton cave beetle. It can not be determined at this time if the species still occurs at the original location or if the species has been extirpated from the site by the closure of the cave entrance. The limestone caves in which this species are found provide a unique and fragile environment that supports a variety of species that have evolved to survive and reproduce under the demanding conditions found in cave ecosystems. The limited distribution of the species makes it vulnerable to isolated events that would only have a minimal effect on the more wide-ranging insects. Events such as toxic chemical spills, discharges of large amounts of polluted water or indirect impacts from off-site construction activities, closure of entrances, alteration of entrances, or the creation of new entrances could have serious adverse impacts on this species. The magnitude of threat is high for this species due to its limited distribution. The immediacy of threat is nonimminent because there are no known projects planned that would affect the species in the next 1-2 years; we therefore have assigned an LPN of 5 to this species. Icebox cave beetle ( *Pseudanophthalmus frigidus* )—The following summary is based upon information in our files. No new information was provided in the petition we received on May 11, 2004. Icebox cave beetle is a small, eyeless, reddish-brown predatory insect that feeds upon small cave invertebrates. It is cave dependent and is not found outside the cave environment. Icebox cave beetle is only known from one privately owned Kentucky cave. The limestone cave in which this species is found provides a unique and fragile environment that supports a variety of species that have evolved to survive and reproduce under the demanding conditions found in cave ecosystems. The species has not been observed since it was originally collected from the only site known to support the species, but species experts believe that it may still exist there in low numbers. The limited distribution of the species makes it vulnerable to isolated events that would only have a minimal effect on the more wide-ranging insects. Events such as toxic chemical spills or discharges of large amounts of polluted water, or indirect impacts from off-site construction activities, closure of entrances, alteration of entrances, or the creation of new entrances, could have serious adverse impacts on this species. The magnitude of threat is high for this species due to its limited distribution. The immediacy of threat is nonimminent because there are no known projects planned that would affect the species in the next 1-2 years; we therefore have assigned an LPN of 5 to this species. Inquirer cave beetle ( *Pseudanophthalmus inquisitor* )—The following summary is based upon information in our files. No new information was provided in the petition we received on May 11, 2004. The inquirer cave beetle is a fairly small, eyeless, reddish-brown predatory insect that feeds upon small cave invertebrates. It is cave dependent and is not found outside the cave environment. The inquirer cave beetle is only known from one privately owned Tennessee cave. The limestone cave in which this species is found provides a unique and fragile environment that supports a variety of species that have evolved to survive and reproduce under the demanding conditions found in cave ecosystems. The species was last observed in 2006. The limited distribution of the species makes it vulnerable to isolated events that would only have a minimal effect on the more wide-ranging insects. The area around the only known site for the species is in a rapidly expanding urban area and indirect impacts, such as chemical or other pollution, could significantly impact both the cave and the species the cave supports. The entrance to the cave is protected by the landowner through a cooperative management agreement with the Service, The Nature Conservancy and Tennessee Wildlife Resources Agency; however, a sinkhole that drains into the cave system is located away from the protected entrance and is near a highway. Events such as toxic chemical spills, discharges of large amounts of polluted water or indirect impacts from off-site construction activities could adversely affect the species. The magnitude of threat is high for this species due to its limited distribution. The immediacy of threat is nonimminent because there are no known projects planned that would affect the species in the next 1-2 years and it receives some protection under a cooperative management agreement; we therefore have assigned an LPN of 5 to this species. Louisville cave beetle ( *Pseudanophthalmus troglodytes* )—The following summary is based upon information in our files. No new information was provided in the petition we received on May 11, 2004. The Louisville cave beetle is a small, eyeless, reddish-brown predatory insect that feeds upon cave invertebrates. It is cave dependent and is not found outside the cave environment. Louisville cave beetle is only known from two privately owned Kentucky caves. The limestone caves in which this species are found provide a unique and fragile environment that supports a variety of species that have evolved to survive and reproduce under the demanding conditions found in cave ecosystems. The limited distribution of the species makes it vulnerable to isolated events that would only have a minimal effect on the more wide-ranging insects. Events such as toxic chemical spills, discharges of large amounts of polluted water or indirect impacts from off-site construction activities, closure of entrances, alteration of entrances, or the creation of new entrances could have serious adverse impacts on this species. The magnitude of threat is high for this species, given its narrow distribution. The immediacy of threat is nonimminent because there are no known projects planned that would affect the species in the next 1-2 years; we therefore have assigned an LPN of 5 to this species. Tatum Cave beetle ( *Pseudanophthalmus parvus* )—The following summary is based upon information in our files. No new information was provided in the petition we received on May 11, 2004. Tatum Cave beetle is a small, eyeless, reddish-brown predatory insect that feeds upon cave invertebrates. It is cave dependent and is not found outside the cave environment. Tatum Cave beetle is only known from one privately owned Kentucky cave. The limestone cave in which this species is found provides a unique and fragile environment that supports a variety of species that have evolved to survive and reproduce under the demanding conditions found in cave ecosystems. The species has not been observed since 1965, but species experts believe that it still exists in low numbers. The limited distribution of the species makes it vulnerable to isolated events that would only have a minimal effect on the more wide-ranging insects. Events such as toxic chemical spills or discharges of large amounts of polluted water, or indirect impacts from off-site construction activities, closure of entrances, alteration of entrances, or the creation of new entrances could have serious adverse impacts on this species. The magnitude of threat is high for this species, because its limited numbers mean that any threats could affect its continued existence. The immediacy of threat is non-imminent because there are no known projects planned that would affect the species in the next 1-2 years; we therefore have assigned an LPN of 5 to this species. Taylor's (Whulge, Edith's) checkerspot butterfly ( *Euphydryas editha taylori* )—The following summary is based on information from our files and in the petition received on December 11, 2002. Historically, the Taylor's checkerspot butterfly was known from 70 locations: 23 in British Columbia, 34 in Washington, and 13 in Oregon. Following surveys during the 2007 flight period, 11 populations were known, with a total of about 2,500-3,000 individuals observed rangewide. Currently, eight populations are known from Washington, two of which are in the Willamette Valley of Oregon, and a new location was discovered in British Columbia, Canada, in 2005. The species had not been detected in Canada since 2000, and many negative surveys were conducted until the species was found at a new location on Denman Island, British Columbia. The size and location of the populations may shift from year to year. Most populations are small, usually with fewer than 5 or 10 butterflies detected; one population on Department of Defense land had more than 1,000 individuals in 2006, but this was an exception. Threats include degradation and destruction of native grasslands to agriculture, residential and commercial development, encroachment by nonnative plants; succession from grasslands to native shrubs and trees, and fire. The grassland ecosystem on which this subspecies depends requires annual management to maintain suitable grassland habitat for the species. Application of *Bacillus thuringiensis* var. *kurstake*

(Btk)for Asian gypsy moth control likely contributed to extirpation of the subspecies at three locations in Pierce County, Washington. The use of Btk continues to be a threat if it is used in areas in proximity to native prairies. The magnitude of threats is high because of the extremely small number of populations, the size of remaining populations, and the collapse in the species' distribution; many of the numerous threats could occur simultaneously and affect most of the populations. Threats are imminent because many are ongoing. We assigned the Taylor's checkerspot butterfly an LPN of 3. Blackline Hawaiian damselfly ( *Megalagrion nigrohamatum nigrolineatum* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The blackline Hawaiian damselfly is a stream-dwelling damselfly species endemic to the island of Oahu, Hawaii. Once known from throughout Oahu, the species is now restricted to 16 streams within the Koolau Mountains. This species is threatened by predation from alien aquatic species such as fish and predacious insects and habitat loss through dewatering of streams and invasive nonnative plants. Nonnative fish and insects prey on the naiads of the damselfly and loss of water reduces the amount of suitable naiad habitat available. Invasive plants ( *e.g.* California grass ( *Brachiaria mutica* )) also contribute to loss of habitat by forming dense, monotypic stands that completely eliminate any open water. These threats are occurring in varying degrees rangewide for the blackline Hawaiian damselfly. Although there are no efforts being done to control or eradicate nonnative fish or insects or to stop the loss of habitat, the 16 streams are widely dispersed on both sides of the mountain range and are highly unlikely to experience complete loss of populations at the same time. Therefore the magnitude of the threats is moderate. Threats to the blackline Hawaiian damselfly from loss of habitat and introduced nonnative fish and insects are ongoing and therefore are imminent. Therefore, we assigned this subspecies an LPN of 9. Crimson Hawaiian damselfly ( *Megalagrion leptodemas* )—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. Flying earwig Hawaiian damselfly ( *Megalagrion nesiotes* )—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. Oceanic Hawaiian damselfly ( *Megalagrion oceanicum* )—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. Orangeblack Hawaiian damselfly ( *Megalagrion xanthomelas* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Megalagrion xanthomelas* is a stream-dwelling damselfly species endemic to the Hawaiian Islands of Kauai, Oahu, Molokai, Maui, Lanai, and Hawaii. The species is now restricted to 16 populations on the islands of Oahu, Maui, Molokai, Lanai, and Hawaii. This species is threatened by predation from alien aquatic species such as fish and predacious insects and habitat loss through dewatering of streams and invasion by nonnative plants. Nonnative fish and insects prey on the naiads of the damselfly and loss of water reduces the amount of suitable naiad habitat available. Invasive plants ( *e.g.* California grass ( *Brachiaria mutica* )) also contribute to loss of habitat by forming dense, monotypic stands that completely eliminate any open water. Nonnative fish and plants are found in all the streams the orangeblack damselfly occur in, except the Oahu location, where there are no nonnative fish. We assigned this species an LPN of 8 because though the threats are ongoing and therefore imminent, they occur in varying degrees throughout the range of the species and are considered of moderate magnitude. Pacific Hawaiian damselfly ( *Megalagrion pacificum* )—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. Picture-wing fly ( *Drosophila attigua* )—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. Picture-wing fly ( *Drosophila digressa* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004, but new information was provided by one *Drosophila* expert in 2006. This picture-wing fly, a member of the family Drosophilidae, feeds only upon species of *Charpentiera* , and is endemic to the Hawaiian Island of Hawaii. Never abundant in number of individuals observed, *D. digressa* was originally known from 5 population sites and may now be limited to as few as 1 or 2 sites. Due to the small population size of the species and its small known habitat area, *Drosophila* researchers believe this species and its habitat are particularly vulnerable to a myriad of threats. Feral ungulates (pigs, goats, and cattle) degrade and destroy *D. digressa* host plants and habitat by directly trampling plants, facilitating erosion, and spreading nonnative plant seeds. Nonnative plants degrade host plant habitat and compete for light, space, and nutrients. Direct predation of *D. digressa* by nonnative social insects, particularly yellow jacket wasps, is also a serious threat. Additionally, this species faces competition at the larval stage from non-native tipulid flies, which feed within the same portion of the decomposing host plant area normally occupied by the *D. digressa* larvae during their development with a resulting reduction in available host plant material. The threats to the native forest habitat of *Drosophila digressa* , and to individuals of this species, occur throughout its range and are expected to continue or increase without their control or eradication, and are considered imminent, because they are ongoing. No known conservation measures have been taken to date to specifically address these threats, and we have therefore assigned this species an LPN of 2. Stephan's riffle beetle ( *Heterelmis stephani* )—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information from our files. No new information was provided in the petition received on May 11, 2004. Dakota skipper ( *Hesperia dacotae* )—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files, including information from the petition received on May 12, 2003. Mardon skipper ( *Polites mardon* )—The following summary is based on information contained in our files and the petition we received on December 24, 2002. The Mardon skipper is a rare northwestern butterfly with a remarkably disjunct range. Currently this species is known from four widely separated regions: south Puget Sound region, southern Washington Cascades, Siskiyou Mountains of southern Oregon, and coastal northwestern California. The number of documented locations for the species has increased from less than 10 in 1997 to more than 50 rangewide in 2007. However, most populations for Mardon skipper are extremely small, and approximately 10 locations have populations with more than 50 individuals. The Mardon skipper spends its entire life cycle in one location, often on the same grassland patch. The dispersal ability for Mardon skipper is restricted. Threats include habitat loss and degradation due to development, overgrazing, use of herbicides and pesticides, encroachment of nonnative and native vegetation, succession from grassland to forest, fire suppression; direct loss of individuals due to fire; recreational activities; insect collecting; and random, naturally occurring events. The species' limited dispersal ability restricts the likelihood of recolonization once a population is lost. The likelihood of Mardon skippers dispersing between suitable habitat patches in a fragmented landscape is low. The magnitude of threats is high because of the small population sizes and disjunct distribution of the species that limits its ability to disperse. Loss of any of the populations could threaten the continued existence of the species within each of its disjunct population centers. It would be unlikely that any threat would affect all known locales simultaneously. Overall, the threats are nonimminent because the threats are not currently occurring at all known population sites. We assign an LPN of 5 to the Mardon skipper. Coral Pink Sand Dunes tiger beetle ( *Cicindela limbata albissima* )—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files, including information from the petition we received on April 21, 1994. Highlands tiger beetle ( *Cicindela highlandensis* )—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Highlands tiger beetle is narrowly distributed and restricted to areas of bare sand within upland oak scrub and pine vegetation on the ancient sand dunes of the Lake Wales Ridge in Polk and Highlands Counties, Florida. Adult tiger beetles have been found at 40 sites from near Haines City south to Josephine Creek. In 2004-2005 surveys, biologists found a total of 1,574 adults at 40 sites, compared with 643 adults at 31 sites in 1996, 928 adults at 31 sites in 1995, and 742 adults at 21 sites in 1993. Of the 40 sites in the 2004-2005 surveys with one or more adults: 3 sites were found to have large populations of over 100 adults [Catfish Creek Preserve (493), Snell Creek South (193), and Flaming Arrow Scout Camp (175)]; 3 sites had populations of 50-99 adults; 8 sites had 20-49 adults, 13 sites had 10-19 adults, and 13 sites had fewer than 10 adults. Results from a limited removal study at four sites suggest that the actual population size at the various survey sites is likely to be as much as two times as high as indicated by the visual index counts. Lack of fire to create open sand, pesticide use, small population sizes, and over-collecting pose serious threats to this species. Because this species is narrowly distributed with specific habitat requirements and small populations, the magnitude of threats is high. Although the majority of its historic range has been lost, degraded, and fragmented, numerous sites are protected and land managers are implementing prescribed fire, which should restore habitat and help reduce threats. Overall, the threats are nonimminent. Therefore, we assigned the Highlands tiger beetle an LPN of 5. Arachnids Warton cave meshweaver ( *Cicurina wartoni* )—The following summary is based on information from our files. No new information was received since the last Candidate Notice of Review published on September 12, 2006, or was provided in the petition we received on May 11, 2004. Warton Cave meshweaver is an eyeless, cave-dwelling, unpigmented, 0.25-inch long invertebrate known only from female specimens. This meshweaver is known to occur in only one cave (Pickle Pit) in Travis County, Texas. Primary threats to the species and its habitat are predation and competition from fire ants and surface and subsurface effects from runoff from an adjacent subdivision. The magnitude of threats is considered high, because the single location for this species makes it highly vulnerable to extinction. The threats are imminent, because fire ants are known to occur in the vicinity of the cave, and impacts to the cave from runoff and human activities are an imminent threat. Thus, we assign an LPN of 2 to this species. Crustaceans Anchialine pool shrimp ( *Metabetaeus lohena* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Metabetaeus lohena* is an anchialine pool-inhabiting species of shrimp belonging to the family Alpheidae. This species is endemic to the Hawaiian Islands and is currently known from populations on the islands of Oahu, Maui, and Hawaii. The primary threats to this species are predation by fish (which do not naturally occur in the pools inhabited by this species) and habitat loss from degradation. The pools where this species occurs on Maui and Hawaii Island are located within State Natural Area Reserves (NAR). Hawaii's State statutes prohibit the collection of the species and the disturbance of the pools in State NARs. The pools where this species occurs on the island of Oahu do not receive protection from collection of the species or disturbance of the pools. Enforcement of collection and disturbance prohibitions is difficult, and the negative effects from the introduction of fish are extensive and happen quickly. Therefore, threats to this species are of a high magnitude. However, we consider the primary threats of predation from fish and loss of habitat due to degradation to be nonimminent, because no fish were observed in any of the pools where this species occurs and there has been no documented dumping in the pools this species occurs in on the islands of Maui or Hawaii. Only one site on Oahu had a dumping instance, and in that case the dumping was cleaned up and the species subsequently returned. No additional dumping events are known to have occurred. Therefore, we assigned this species an LPN of 5. Anchialine pool shrimp ( *Palaemonella burnsi* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Palaemonella burnsi* is an anchialine pool-inhabiting species of shrimp belonging to the family Palaemonidae. This species is endemic to the Hawaiian Islands and is currently known from three populations on the island of Maui and one population on the island of Hawaii. The primary threats to this species are predation by fish (which do not naturally occur in the pools inhabited by this species) and habitat loss due to degradation. The pools where this species occurs on Maui are located within a State Natural Area Reserve (NAR). Hawaii's State statutes prohibit the collection of the species and the disturbance of the pools in State NARs. On the island of Hawaii, the species occurs within a National Park, and collection and disturbance are also prohibited. However, enforcement of these prohibitions is difficult, and the negative effects from the introduction of fish are extensive and happen quickly. Therefore, threats to this species are of high magnitude. However, threats are considered nonimminent, because a 2004 survey did not find fish in the pools where these shrimp occur on Maui or the island of Hawaii, and there was no evidence of recent habitat degradation. Therefore, the threats of predation from fish and habitat degradation are nonimminent, and we assigned this species an LPN of 5. Anchialine pool shrimp ( *Procaris hawaiana* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Procaris hawaiana* is an anchialine pool-inhabiting species of shrimp belonging to the family Procarididae. This species is endemic to the Hawaiian Islands and is currently known from two populations on the island of Maui and one population on the island of Hawaii. The primary threats to this species are predation from fish (which do not naturally occur in the pools inhabited by this species) and habitat loss due to degradation. The pools where this species occurs on Maui are located within a State Natural Area Reserve (NAR). Hawaii's State statutes prohibit the collection of the species and the disturbance of the pools in State NARs. However, enforcement of these prohibitions is difficult and the negative effects from the introduction of fish are extensive and happen quickly. There are no conservation efforts underway to alleviate the potential for any of these threats in the one pool on the island of Hawaii. Therefore, threats to this species remain at high magnitude. However, the threats to the species are nonimminent because, during a 2004 survey, no fish were observed in the pools where these shrimp occur on Maui and no fish were observed in the one pool on the island of Hawaii during a site visit in 2005. In addition, there were no signs of dumping or fill in any of the pools where the species occurs. Therefore, we assigned this species an LPN of 5. Anchialine pool shrimp ( *Vetericaris chaceorum* )—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Vetericaris chaceorum* is an anchialine pool-inhabiting species of shrimp belonging to the family Procarididae; it is the only species in its genus. This species is endemic to the Hawaiian Islands and is only known from one population in a single pool on the island of Hawaii. The primary threats to this species are predation from nonnative fish and habitat degradation and contamination from illegal trash dumping. This species would be highly vulnerable to predation by any intentionally or accidentally introduced fish, or contamination from illegal dumping into its single known location. This pool lies within lands administered by the State of Hawaii Department of Hawaiian Home Lands. The threats to *Vetericaris chaceorum* from habitat degradation and destruction, and predation by nonnative fish are of high magnitude, because this species occurs in only one pool. All individuals of this species may be adversely impacted by a single dumping of trash or release of nonnative fish in its only known pool. However, the threats are nonimminent, as fish have not been introduced into the pool (nor is there any reason to believe that introduction is imminent) and a site visit in early 2005 showed there were no signs of dumping or fill. Therefore we assigned this species an LPN of 4 because the threats are of high magnitude though nonimminent, and the species is in a monotypic genus. Troglobitic groundwater shrimp ( *Typhlatya monae* )—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files, including information from the petition we received on May 11, 2004. Flowering plants *Abronia alpina* (Ramshaw Meadows sand-verbena)—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. *Arabis georgiana* (Georgia rockcress)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Georgia rockcress grows in a variety of dry situations, including shallow soil accumulations on rocky bluffs, ecotones of gently sloping rock outcrops, and in sandy loam along eroding river banks. It is occasionally found in adjacent mesic woods, but it will not persist in heavily shaded conditions. Currently a total of 20 populations are known from the Gulf Coastal Plain, Piedmont, and Ridge and Valley physiographic provinces of Alabama and Georgia. Populations of this species typically have a limited number of individuals over a small area. Habitat degradation, more than outright habitat destruction, is the most serious threat to the continued existence of this species. Disturbance, associated with timber harvesting, road building, and grazing has created favorable conditions for the invasion of exotic weeds, especially Japanese honeysuckle ( *Lonicera japonica* ), in this species' habitat. Eight populations are currently or potentially threatened by the presence of exotics. The heritage programs in Alabama and Georgia have initiated plans for exotic control at several populations. The magnitude of threats to this species is moderate to low due to the number of populations

(20)across multiple counties in two states and the nature of the threats. However, since a number of the populations are currently being affected by nonnative plants, the threat is imminent. Thus, we assigned an LPN of 8 to this species. *Argythamnia blodgettii* (Blodgett's silverbush)—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. Blodgett's silverbush is found in open, sunny areas in pine rockland, edges of rockland hammock, edges of coastal berm, and sometimes disturbed areas at the edges of natural areas. Plants can be found growing from crevices on limestone, or on sand. The pine rockland habitat where it occurs in Miami-Dade County and the Florida Keys requires periodic fires to maintain habitat with a minimum amount of hardwoods. Based upon available data, there are approximately 27 extant occurrences, 12 in Monroe County and 15 in Miami-Dade County; many occurrences are on conservation lands; however, 4-5 sites are recently thought to be extirpated or destroyed. The estimated population size of Blodgett's silverbush in the Florida Keys, excluding Big Pine Key, is roughly 11,000; the estimated population in Miami-Dade County is 375 to 13,650 plants. Blodgett's silverbush is threatened by habitat loss, which is exacerbated by habitat degradation due to fire suppression, the difficulty of applying prescribed fire to pine rocklands, and threats from exotic plants. Remaining habitats are fragmented. Threats such as road maintenance, road enhancement, infrastructure, and illegal dumping threaten some populations. Blodgett's silverbush is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges. Sea level rise is a long-term threat that will continue; it is expected to continue to affect pine rocklands and ultimately reduce the extent of available habitat, especially in the Keys. Overall, the magnitude of threats is moderate and the threats are nonimminent. Thus, we assigned an LPN of 11 to this species. *Artemisia campestris* var. *wormskioldii* (Northern wormwood)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Historically known from eight sites, northern wormwood is currently known from only two populations in Klickitat and Grant Counties, Washington. This plant is restricted to exposed basalt, cobbly-sandy terraces, and sand habitat along the shore and on islands in the Columbia River. The two sites are separated by 200 miles (322 kilometers) of the Columbia River and three large hydroelectric dams. The Klickitat County population is declining; it is unclear whether the Grant County population is stable or declining, but it is vulnerable to environmental variability. Surveys of apparently suitable habitat along the Hanford Reach have not detected any additional plants. Threats to northern wormwood include direct loss of suitable habitat through regulation of water levels in the Columbia River and placement of riprap along the river bank; trampling of plants as a result of recreational use; competition with non-native invasive species; burial by wind and water-borne sediments; a small population size that makes both sites susceptible to genetic drift and inbreeding; and the potential for hybridization with two other species of *Artemisia* . Ongoing conservation actions have reduced trampling, but have not eliminated or reduced the other threats at the Grant County site. The magnitude of threat is high for this subspecies, because the only two remaining populations are widely separated and distributed such that one or both populations could be eliminated by a single disturbance. The threats are imminent, because recreational use is ongoing, invasive nonnative species occur at both sites, erosion of the substrate is ongoing at the Klickitat County site, and high water flows are random, naturally occurring events that may occur unpredictably in any year. Therefore, we have retained an LPN of 3 for this subspecies. *Astelia waialealae* (Pa'iniu)—We have not updated our candidate assessment as we are currently developing a proposed listing rule for this species. *Astragalus tortipes* (Sleeping Ute milkvetch)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Sleeping Ute milkvetch is a perennial plant that grows only on the Smokey Hills layer of the Mancos Shale Formation on the Ute Mountain Ute Indian Reservation in Montezuma County, Colorado. In 2000, 3,744 plants were recorded at 24 locations covering 500 acres within an overall range of 64,000 acres. Available information from 2000 indicates that the species remains stable. Recently, the Tribe expressed interest in conducting new surveys and initiating protection for the species. Previous and ongoing threats from borrow pit excavation, off-highway vehicles, irrigation canal construction, and a prairie dog colony have had minor impacts that reduced the range and number of plants by small amounts. Off-highway vehicle use of the habitat is reportedly increasing. Oil and gas development is active in the general area, but we have received no information from the tribe to indicate whether there is development within the habitat for the plants. The threats are moderate in magnitude, since they have had minor impacts and, based on information we have, the population appears to be stable. In addition, the Tribe indicated that it is developing a management plan for the species and has started to implement some protective measures such as installing fencing and removing cattle from the fenced area where the plants occur. Because of the general lack of information on current threats from the Tribe, imminence of threats is not fully known. While ORV use is currently occurring and may be increasing, oil and gas production is not known to currently occur in the areas where this species exists. Overall, we conclude threats are nonimminent. Therefore, we assigned a LPN of 11 to this species. *Bidens amplectens* (Kookooalu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is an erect perennial or facultative annual herb found in mixed lowland dry shrubland/grassland on Oahu, Hawaii. Known from one population of 500 to 1,000 individuals in the Waianae Mountains, the threats to this species are nonnative plants that increase the fuel load and fire threat, and compete for habitat. The magnitude of threats continues to be high because no conservation measures have been taken to address them and because of the potential for the elimination of the only known population by a single stochastic or naturally occurring event. Threats continue to be imminent because they are ongoing. We retained an LPN of 2 for this species. *Bidens campylotheca* ssp. *pentamera* (Kookooalu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This subspecies is an erect, perennial herb found in *Cheirodendron-Metrosideros polymorpha* (olapa-ohia) montane wet forest on Maui, Hawaii. This subspecies is known from four populations with a total of approximately 350 individuals. *Bidens campylotheca* ssp. *pentamera* is threatened by feral pigs that degrade and destroy habitat, and by nonnative plants that compete for habitat. Feral pigs have been fenced out of one population at Kipahulu. The remaining populations on east and west Maui are still affected by these threats. This subspecies is represented in an *ex-situ* collection. However, these on-going conservation efforts benefit only one of the four known populations and therefore threats continue to be of a high magnitude, because they threaten the continued existence of this subspecies. In addition, threats to *B. campylotheca* ssp. *pentamera* are imminent because they are ongoing in three populations. Therefore, we retained an LPN of 3 for this subspecies. *Bidens campylotheca* ssp. *waihoiensis* (Kookooalu)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Bidens conjuncta* (Kookooalu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Bidens conjuncta* is an erect, perennial herb found in *Metrosideros-Dicranopteris-Cheirodendron* (ohia-uluhe-olapa) lowland to montane wet forest and shrubland on Maui, Hawaii. Seven populations are known, totaling approximately 2,200 individuals scattered throughout upper elevation drainages of west Maui. Although the overall range of the species has not changed, the number of individuals has declined over the last decade or so. This species is threatened by pigs that degrade and destroy habitat, and eat vegetative parts and fruit of *B. conjuncta* , and by nonnative plants that outcompete and displace it. Feral pigs have been fenced out of portions of the populations of *B. conjuncta* , and nonnative plants have been greatly reduced in the fenced areas. The threats from feral pigs and nonnative plants are, therefore, of a moderate magnitude to this species. However, these threats are imminent because they are ongoing. Therefore, we retained an LPN of 8 for this species. *Bidens micrantha* ssp. *ctenophylla* (Kookooalu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This subspecies is an erect, perennial herb found in open mixed shrubland to dry *Metrosideros*

(ohia)forest on the island of Hawaii, Hawaii. This subspecies is endemic to the island of Hawaii, where it is restricted to an area of less than 10 square miles (26 square kilometers). *Bidens micrantha* ssp. *ctenophylla* is known from three wild and four outplanted populations totaling approximately 2,000 to 3,000 individuals, the majority of which occur in only two

(wild)populations. This subspecies is threatened by fire and nonnative plants, and two populations are threatened by residential and commercial development. The threats to *B. micrantha* ssp. *ctenophylla* from fire and nonnative plants are of a high magnitude and imminent because they are occurring range-wide, they threaten the continued existence of the species, and no efforts for their control have been undertaken. In addition, two populations are also threatened by development. Therefore, we retained an LPN of 3 for this subspecies. *Brickellia mosieri* (Florida brickell-bush)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is restricted to pine rocklands of Miami-Dade County, Florida. This habitat requires periodic prescribed fires to maintain the low understory and prevent encroachment by native tropical hardwoods and exotic plants, such as Brazilian pepper. Only one large population (up to 10,000 individuals) is known to exist, plus 18 other occurrences each containing less than 100 individuals. Ten of these occurrences are on conservation lands. This species is threatened by habitat loss, which is exacerbated by habitat degradation due to fire suppression, the difficulty of applying prescribed fire to pine rocklands, and threats from exotic plants. Remaining habitats are fragmented. The species is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges. Due to its restricted range and the small sizes of most isolated occurrences, this species is vulnerable to environmental (catastrophic hurricanes), demographic (potential episodes of poor reproduction), and genetic (potential inbreeding depression) threats. Thus, the overall magnitude of threat is moderate. The threats are ongoing and thus imminent. We assigned this species an LPN of 8. *Calamagrostis expansa* (Maui reedgrass)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is a robust, short-rhizomatous perennial found in wet forest, open bogs, and bog margins on the islands of Maui and Hawaii, Hawaii. Historically rare, *C. expansa* was restricted to wet forest and bogs on Maui. It is unknown what the historical status was on Hawaii. Currently, this species is known from 100 populations totaling approximately 400 individuals on Maui, and was recently discovered in five populations totaling approximately 300 individuals on the island of Hawaii. *Calamagrostis expansa* is threatened by pigs that degrade and destroy habitat and by nonnative plants that outcompete and displace it. Feral pigs have been fenced out of most of the west Maui populations where *C. expansa* currently occurs, and nonnative plants have been reduced in the fenced areas. However, the threats are not controlled and are ongoing in the remaining unfenced populations on Maui and in all of the populations on the island of Hawaii. Therefore, the threats from feral pigs and nonnative plants are of a high magnitude and imminent for *C. expansa* and we retained an LPN of 2 for this species. *Calamagrostis hillebrandii* (Hillebrand's reedgrass)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Calamagrostis hillebrandii* is a slender, short-rhizomatous perennial found in *Metrosideros-Machaerina* montane wet bog or *Metrosideros-Rhynchospora-Oreobolus* mixed bog on Maui, Hawaii. This species is known from two populations of about 2,000 individuals, restricted to the bogs of west Maui. There is an unconfirmed report of *C. hillebrandii* from central Molokai. This species is currently threatened by pigs that degrade and destroy habitat and nonnative plants that outcompete and displace it. A portion of one population is protected by an ungulate exclosure fence while the other population may indirectly benefit from conservation actions for ungulate control and control of nonnative plants conducted in a nearby preserve. The threats are imminent because they are ongoing in one of the two known populations. Because they threaten the continued existence of the species, the threats are high in magnitude. Therefore, we retained an LPN of 2 for this species. *Calliandra locoensis* (no common name)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *Calliandra locoensis* is a spiny, leguminous shrub currently known from only two localities within the Susúa Commonwealth Forest in the municipalities of Yauco and Sabana Grande, in southwestern Puerto Rico. Twenty-five native species of *Calliandra* have been reported for the Antilles, three of which are native to Puerto Rico, including *Calliandra locoensis* . This species is endemic to Puerto Rico, and was discovered in 1991 during a study of the flora of the Susúa Commonwealth Forest. It was described by García and Kolterman in 1992. *Calliandra locoensis* is found along one creek in semi-evergreen to deciduous forests on shallow, serpentine soils with low nutrients, high drainage, and low fertility. Much of the vegetation in the forest was cut for wood, cultivation, livestock grazing, and charcoal production, prior to its designation as a public forest. *Calliandra locoensis* exhibits a low degree of self-compatibility in pollination tests. Seeds have a short viability period, do not appear to have a biotic dispersal agent (dispersed by dehiscence—seed pod splits open), and require mesic conditions for germination, which may be factors in the limited distribution of the species. The small number of individuals in the two populations, restricted distribution (two localities), forest management practices (accidental trampling, brush clearing, trail maintenance), forest fires (natural or manmade), and catastrophic natural events (hurricanes, floods, mudslides), threaten this species. We assigned an LPN of 5 to this species because the magnitude of threat to *Calliandra locoensis* is high because the threats can result in direct mortality and further reduce the populations, combined with its restricted distribution, apparent low dispersal capability, and population number (only two small populations relatively close to one another). The threats are nonimminent given that the populations are found within protected lands and there are no known projects or management activities planned that would destroy the known populations of *Calliandra locoensis* . *Calochortus persistens* (Siskiyou mariposa lily)—The following summary is based on information contained in our files and the petition we received on September 10, 2001. The Siskiyou mariposa lily is a narrow endemic that is restricted to two disjunct ridge tops in the Klamath-Siskiyou Range on the California-Oregon border. In California, this species is currently found at nine separate sites on approximately 10 hectares

(ha)(24.7 acres (ac)) of Klamath National Forest and privately owned lands that stretch for 6 kilometers

(km)(3.7 miles (mi)) along the Gunsight-Humbug Ridge. In 1998, five Siskiyou mariposa lily plants were discovered on Bald Mountain, west of Ashland, Jackson County, Oregon. Major threats include competition and shading by native and nonnative species fostered by suppression of wild fire; increased fuel loading and subsequent risk of wild fire; fragmentation by roads, fire breaks, tree plantations, and radio-tower facilities; maintenance and construction around radio towers and telephone relay stations located on Gunsight Peak and Mahogany Point; and soil disturbance and exotic weed and grass species introduction as a result of heavy recreational use and construction of fire breaks. Dyer's woad ( *Isatis tinctoria* ), an invasive, nonnative plant that may prevent germination of Siskiyou mariposa lily seedlings, is now found throughout the California population, affecting 90 percent of the known lily habitat. Forest Service staff and the Klamath-Siskiyou Wildlands Center cite competition with dyer's woad as a significant and chronic threat to the survival of Siskiyou mariposa lily. The combination of restricted range, extremely low numbers (five plants) in one of two disjunct populations, poor competitive ability, short seed dispersal distance, slow growth rates, low seed production, apparently poor survival rates in some years and competition from exotic plants threaten the continued existence of this species. Because of the restricted range and low numbers, the magnitude of threats is high. While some of the threats are ongoing, others are not, and overall the threats are nonimminent. We assigned an LPN of 5 to this species. *Calyptranthes estremerae* (no common name)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *Calyptranthes estremerae* is a small tree from the subtropical moist forest of northwestern Puerto Rico, in the municipalities of Camuy, Utuado, and Arecibo. *Calyptranthes estremerae* was only known from several individuals found near the recreation area adjacent to the Camuy Caves, but specimens were later found within the Río Abajo Commonwealth Forest (up to 50 individuals) at a site that was affected by the construction of Highway PR 10 in 1995. At the present time, a minimum of 100 specimens of *Calyptranthes estremerae* are estimated for the Río Abajo Commonwealth Forest and undetermined number in the Camuy area. The magnitude of threat to *Calyptranthes estremerae* is considered high, due to restricted distribution and small number of individuals, catastrophic natural events, and the potential destruction of specimens from expansion of recreational facilities. However, these threats are not imminent, because the largest known population of *Calyptranthes estremerae* is found within protected lands, there are no known projects planned that would destroy the sites, and the species can be transplanted successfully. Therefore, we assign an LPN of 5 to *Calyptranthes estremerae* . *Canavalia napaliensis* (Awikiwiki)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Canavalia pubescens* (Awikiwiki)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Awikiwiki is a perennial climber found in lowland dryland forest on Maui and Lanai, and is possibly on the island of Niihau, Hawaii. This species is known from eight populations totaling at least 123 individuals. This species is threatened by development (Maui), goats

(Maui)and axis deer (Maui and Lanai) that degrade and destroy habitat, and by nonnative plants that outcompete and displace native plants (both islands). An ungulate exclosure fence protects six individuals of *C. pubescens* , and weed control is ongoing at this location on Maui. This species is represented in two *ex situ* collections. Threats to this species from feral goats, axis deer, and nonnative plants are ongoing, or imminent, and of high magnitude because they significantly affect the species throughout its range. Therefore, we retained an LPN of 2 for this species. *Castilleja christii* (Christ's paintbrush)—The following summary is based on information contained in our files and the petition we received on January 2, 2001. *Castilleja christii* is found in one population on the summit of Mount Harrison in Cassia County, Idaho. This endemic species is considered a hemiparasite, and it grows in association with subalpine meadow and sagebrush habitats. The population found on 85 ha (220 ac) may be large (greater than 10,000 individual plants); however, an accurate current population estimate is not yet available. Monitoring indicates that reproductive stems per plant and plant density decreased significantly between 1995 and 2005. The largest threat to the species is from nonnative invasive plants, the majority of which is smooth brome ( *Bromus inermis* ). Despite a commitment by the Forest Service and the Service to control smooth brome until our efforts are successful or for the next 10 years, recent control efforts conducted in 2005 and 2006 have not been successful in reducing the smooth brome infestation. Other threats to *Castilleja christii* from recreational use appear to be mostly seasonal and affect only a small portion of the population, although they too are imminent. The magnitude of the threats is moderate at this time, primarily due to the lack of control over the smooth brome infestation. This threat from smooth brome is imminent because the threat still persists in levels that affect the native plant community that provides habitat for *C. christii* . Thus, we assign an LPN of 8 to this species. *Chamaecrista lineata* var. *keyensis* (Big Pine partridge pea)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. New survey results were attained in March 2006. *Chamaesyce deltoidea pinetorum* (Pineland sandmat)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Chamaesyce deltoidea* ssp. *serpyllum* (Wedge spurge)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. *Chamaesyce eleanoriae* (Akoko)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Chamaesyce remyi* var. *kauaiensis* (Akoko)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Chamaesyce remyi* var. *remyi* (Akoko)—We have not updated our candidate assessment for this species as we are currently developing a proposed listing rule. *Charpentiera densiflora* (Papala)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Chorizanthe parryi* var. *fernandina* (San Fernando Valley spineflower)—The following summary is based on information contained in our files and the petition we received on December 14, 1999. *Chorizanthe parryi* var. *fernandina* is a low-growing herbaceous annual plant in the buckwheat family. Germination occurs following the onset of late-fall and winter rains and typically represents different cohorts from the seed bank. Flowering occurs in the spring, generally between April and June. *Chorizanthe parryi* var. *fernandina* grows up to 30 centimeters in height and 5 to 40 centimeters across. The plant currently is known from two disjunct localities: the first is in the southeastern portion of Ventura County on a site formerly known as Ahmanson Ranch, and the second is in an area of southwestern Los Angeles County known as Newhall Ranch. Investigations of historical locations and seemingly suitable habitat within the range of the species have not revealed any other occurrences. The threats currently facing San Fernando Valley spineflower include threatened destruction, modification, or curtailment of its habitat or range, and other natural or manmade factors. The threats to *Chorizanthe parryi* var. *fernandina* from habitat destruction or modification are less than they were four years ago. One of the two populations (Ahmanson Ranch) is in permanent, public ownership and is being managed by an agency that is working to conserve the plant. The other population (Newhall Ranch) is under threat of development; however, a Candidate Conservation Agreement

(CCA)is being developed with the landowner, and it is possible that the remaining plants can also be conserved. Until such an agreement is finalized, the threat of development and the potential damage to the Newhall Ranch population still exists, as shown by the destruction of some plants during installation of an agave farm. *Chorizanthe parryi* var. *fernandina* may be threatened by invasive nonnative plants, including grasses, which could potentially displace it from available habitat; compete for light, water, and nutrients; and reduce survival and establishment. *Chorizanthe parryi* var. *fernandina* is particularly vulnerable to extinction due to its concentration in two isolated areas. The existence of only two areas of occurrence, and a relatively small range, makes the variety highly susceptible to extinction or extirpation from a significant portion of its range due to random events such as fire, drought, erosion, or other occurrences. We retained an LPN of 6 for *C. parryi* var. *fernandina* due to high-magnitude, nonimminent threats. *Chromolaena frustrata* (Cape Sable thoroughwort)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is found most commonly in open sun to partial shade at the edges of rockland tropical hammock and in coastal rock barrens. There are nine extant occurrences located at five islands in the Florida Keys and one small area in Everglades National Park. The plant has been extirpated from half of the islands where it occurred. Prior to Hurricane Wilma in 2005, the population was estimated at roughly 5,000 individuals, with all but 500 occurring on one privately owned island. This species is threatened by habitat loss and modification, even on public lands, and habitat loss and degradation due to threats from exotic plants at almost all sites. The species is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges. While these factors may also work to maintain coastal rock barren habitat in the long-term, Hurricane Wilma appears to have had severe impacts, at least in the short-term. Plants have not been located in Everglades National Park since Hurricane Wilma and other occurrences probably declined due to inundation of its coastal barren and rockland hammock habitats. The long-term effects of these impacts are unknown. Sea level rise is considered a major threat that will continue. Potential effects from other changes in fresh water deliveries and the construction of the Buttonwood Canal are unknown. Problems associated with small population size and isolation are likely major factors, as occurrences may not be large enough to be viable; this narrowly endemic plant has uncertain viability at most locations, especially following Hurricane Wilma. Thus, these factors constitute a high magnitude of threat. Threats are imminent as they are ongoing. As a result, we assigned an LPN of 2 to this species. *Consolea corallicola* (Florida semaphore cactus)—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. The Florida semaphore cactus is endemic to the Florida Keys and was discovered on Big Pine Key in 1919 but has since been extirpated there as a result of road building and poaching. This cactus grows close to salt water on bare rock with a minimum of humus soil cover in or along the edges of hammocks near sea level. The species is known to occur naturally only in two areas, Little Torch Key and Biscayne National Park. Outplanting has resulted in the reestablishment of a population in Dagny Johnson Key Largo Hammock Botanical State Park in North Key Largo as well as in some of the lower keys. Outplanting success has been low and more research is needed to determine the requirements of this cactus. Few plants remain in the population at The Nature Conservancy's Torchwood Hammock Preserve on Little Torch Key. Two sexual morphs (males and weak hermaphrodites) comprise the population on Little Torch Key. The female sex morph is absent from the population and sexual reproduction at this site is not possible without human intervention. Regeneration in this population is restricted to clonal propagation. At least 629 plants were discovered on a key in Biscayne National Park in November of 2001. During monitoring work conducted in 2005, a total of 655 plants were documented. Recent studies have found no genetic diversity within the two wild populations. The results were consistent with previous reproductive biology studies that suggested that the cactus does not propagate sexually and that asexual reproduction is the main life history strategy of this species. The causes for the population decline of this species include destruction or modification of habitat, predation from *Cactoblastis cactorum* moths and disease, poaching and vandalism, sea level rise, and hurricanes. Because of low population numbers, lack of variation between and within populations, reproductive problems, and numerous ongoing threats, we assigned this species an LPN of 2. *Cordia rupicola* (no common name)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *Cyanea asplenifolia* (Haha)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyanea asplenifolia* is a shrub found in *Acacia-Metrosideros* (koa-ohia) forest on Maui, Hawaii. Currently, this species is known from three populations totaling fewer than 187 individuals. *Cyanea asplenifolia* is threatened by pigs, goats, and cattle that degrade and destroy habitat and by nonnative plants, such as Australian tree fern, that outcompete and displace it. This species is likely threatened by habitat degradation caused by axis deer and by feral ungulates, rats, and slugs that may directly prey upon and defoliate individuals. Pig and goat exclusion fences protect individuals of two of the three known populations of this species and nonnative plants have been reduced in one fenced area; however, continued monitoring of these fences will be necessary, as feral ungulates from surrounding areas can easily access unmaintained fenced areas. This species is represented in three *ex-situ* collections. The threats continue to be of a high magnitude because they significantly affect the species resulting in direct mortality or reduced reproductive capacity. The threats are imminent because they are ongoing in at least two of the three known populations. Therefore, we retained an LPN of 2 for this species. *Cyanea calycina* (Haha)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is an unbranched shrub found in *Acacia-Metrosideros-Dicranopteris* (koa-ohia-uluhe) montane mesic to wet forest and wet gulches and streambanks on Oahu, Hawaii. *Cyanea calycina* is known from 28 populations totaling approximately 262 individuals. This species is threatened by pigs that degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Potential threats to this species include goats that degrade and destroy habitat, and rats and slugs that may directly prey upon and defoliate individuals. Ungulate fences provide protection to five populations of *C. calycina* in the Waianae Mountains, but the fences must be continually maintained to prevent incursion. Nonnative plants are currently being controlled within the fenced areas, and partial control measures are being implemented to address potential threats from rats. There are no other conservation measures underway in the other 23 populations to alleviate these ongoing, or imminent, threats to *C. calycina* . These threats are of a high magnitude because they significantly affect the species throughout its limited range resulting in direct mortality or reduced reproductive capacity. The threats are imminent in all but five populations. Therefore, we retained an LPN of 2 for this species. *Cyanea eleeleensis* (Haha)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Cyanea kuhihewa* (Haha)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Cyanea kunthiana* (Haha)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyanea kunthiana* is a shrub found in closed *Metrosideros-Dicranopteris* (ohia-uluhe) montane wet forest on Maui, Hawaii. The historic range of *C. kunthiana* was wet forest on the island of Maui. Currently, *C. kunthiana* is declining throughout its range and is known from 15 populations with a combined total of slightly more than 200 individuals. This species is threatened by pigs that directly prey upon the plants and degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Potential threats to this species include rats and slugs that may directly prey upon and defoliate individuals. While large-scale fencing, ungulate removal, and invasive species control measures are underway in areas in which five of the current populations exist, these efforts have not served to completely remove these threats, and there are no efforts to control the ongoing and imminent threats to the other 10 populations. Therefore, the threats continue to be of a high magnitude to *C. kunthiana* . Because the threats continue to be of a high magnitude and are imminent for 10 of the 15 populations, we retained an LPN of 2 for this species. *Cyanea lanceolata* (Haha)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyanea lanceolata* is a shrub found in *Acacia koa-Metrosideros polymorpha* (koa-ohia) lowland mesic forest on Oahu, Hawaii. This species is known from six populations totaling fewer than 100 individuals. *Cyanea lanceolata* is threatened by pigs that eat plants and degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Likely threats to this species include rats and slugs that may directly prey upon and defoliate individuals. This species is represented in an *ex-situ* collection. There are no conservation measures underway to alleviate the ongoing, or imminent, threats to *C. lanceolata.* These threats are of a high magnitude because they are occurring throughout its limited range and they significantly affect species resulting in direct mortality or reduced reproductive capacity. The threats are ongoing, and, therefore, imminent, in all populations. Therefore, we retained an LPN of 2 for this species. *Cyanea obtusa* (Haha)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyanea obtusa* is a shrub found in *Metrosideros polymorpha*

(ohia)mixed mesic forest on Maui, Hawaii. This species is known from three populations with a combined total of fewer than 44 individuals, with 30 of these being possible hybrids. *Cyanea obtusa* is threatened by feral goats, pigs, and cattle that degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Potential threats include fire, and rats and slugs that may directly prey upon and defoliate individuals of *C. obtusa.* Feral pigs have been fenced out of one of the three populations of this species. Nonnative plant control is underway in the fenced area. Although one of the three populations of *C. obtusa* has been fenced and is undergoing weed control, there are no efforts to control the ongoing and imminent threats to the other two populations. The threats continue to be of a high magnitude for *C. obtusa* because they significantly affect the species resulting in direct mortality or reduced reproductive capacity. Therefore, we retained an LPN of 2 for this species. *Cyanea tritomantha* (Aku)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyanea tritomantha* is a palm-like tree found in *Metrosideros-Cibotium* montane wet forest on the island of Hawaii, Hawaii. This species is known from five populations with a total of approximately 135 wild and 373 outplanted individuals in Olaa, Kau, and Laupahoehoe on the island of Hawaii. *Cyanea tritomantha* is threatened by pigs and cattle that degrade and destroy habitat, and nonnative plants that outcompete and displace it. Potential threats to this species include rats and slugs that may directly prey upon and defoliate individuals, and human trampling of individuals located near trails. Feral pigs and cattle have been fenced out of three populations of *C. tritomantha* and nonnative plants have been reduced in the fenced areas. Although three populations of *C. tritomantha* have been fenced and weeds are being controlled in these fenced areas, there are no efforts to control the ongoing and imminent threats to the other populations. The threats continue to be of a high magnitude to *C. tritomantha* because they significantly affect the species resulting in direct mortality or reduced reproductive capacity. Because the threats continue to be of a high magnitude and are imminent for the unmanaged populations, we retained an LPN of 2 for this species. *Cyrtandra filipes* (Haiwale)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Haiwale is a shrub found in lowland to montane wet forest on Maui and Molokai, Hawaii. Historically rare, *C. filipes* was found in southeastern Molokai and west Maui. Currently, this species is known from nine populations, three on Molokai and six on west Maui, totaling approximately 2,000 individuals. There is some question as to the true identity of the Maui populations, which do not fit the description of the species precisely. If, upon further taxonomic study, the Maui populations are determined not to be this species, then it is even more rare, with only the Molokai population of a few individuals remaining. *Cyrtandra filipes* is threatened by pigs, goats, and deer that degrade and destroy habitat, by nonnative plants that outcompete and displace it, and potentially by rats that directly prey on it. Feral pigs have been fenced out of one of the populations of *C. filipes,* and strategic fencing for axis deer is under construction on west Maui, but deer are able to jump over most pig exclusion fences so they are still considered a threat. Nonnative plants are being reduced in the population that is fenced but all populations are potentially threatened by rats. The threats from pigs and nonnative plants are of a high magnitude because of their severity and the fact that they occur in eight of the nine known populations. In addition, these threats are imminent because they are ongoing. Therefore, we retained an LPN of 2 for this species. *Cyrtandra kaulantha* (Haiwale)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyrtandra kaulantha* is a shrub found in moist wooded gulches in dense shade on Oahu, Hawaii. This species is known from four populations with a total of 29 individuals in subgulches in Waianu Valley. *Cyrtandra kaulantha* is threatened by pigs that degrade and destroy habitat, nonnative plants that outcompete and displace it, genetic bottlenecks, random demographic fluctuations, and stochastic environmental events such as tree falls and hurricanes. Direct predation by slugs is a potential threat, as well. None of the populations are protected by fences. Nonnative plants have been reduced in the four known populations. There are no other conservation measures being taken to alleviate these ongoing and imminent threats to *C. kaulantha.* These threats are of a high magnitude because of their severity and the fact that they are occurring throughout its limited range. Therefore, we retained an LPN of 2 for this species because the threats continue to be of a high magnitude and are imminent in all populations. *Cyrtandra oenobarba* (Haiwale)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Cyrtandra oxybapha* (Haiwale)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyrtandra oxybapha* is a shrub found in *Metrosideros polymorpha-Cheirodendron trigynum* (ohia-olapa) montane wet forest to mesic *Acacia-Metrosideros* (koa-ohia) forest on Maui, Hawaii. Currently, this species is known only from one population totaling 50 to 100 individuals in the Kahikinui area of east Maui and one additional population of 20 to 30 individuals on west Maui. This species is threatened by pigs, goats, and cattle that degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Fire is a likely threat at the Kahikinui population. The individuals within the fence at Kahikinui benefit from management actions; however, the remaining individuals there and on west Maui are threatened by pigs, goats, cattle, and likely threatened by fire. The threats are of a high magnitude because of their severity and are imminent since they are ongoing. Therefore, we retained an LPN of 2 for *C. oxybapha.* *Cyrtandra sessilis* (Haiwale)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Cyrtandra sessilis* is a shrub found in wet gulch bottoms and slopes of mesic valleys and wet forests on Oahu, Hawaii. This species is known from two populations totaling approximately 80 individuals in Waikane and Hawaii Loa in the Koolau Mountains. *Cyrtrandra sessilis* is threatened by pigs that degrade and/or destroy habitat, by nonnative plants that outcompete and displace it, and by reduced reproductive vigor. Flooding and landslides are likely threats to one population. No on-the-ground conservation efforts have been initiated, but this species is represented in an *ex-situ* collection. Pigs and nonnative plants are found throughout the mesic and wet forest habitat in which *C. sessilis* occurs, making these threats ongoing and imminent. These threats are of high magnitude because of their severity and because they are occurring throughout its limited range. We retained an LPN of 2 for this species. *Dalea carthagenensis floridana* (Florida prairie-clover)—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Dichanthelium hirstii* (Hirsts' panic grass)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *D. hirstii* is a perennial grass that produces erect leafy flowering stems from May to October. *D. hirstii* occurs in coastal plain intermittent ponds, usually in wet savanna or pine barren habitats and is found at only two sites in New Jersey, one site in Delaware, and one site in North Carolina. While all four extant *D. hirstii* populations are located on public land or privately owned conservation lands, natural threats to the species from encroaching vegetation and fluctuations in climatic conditions remain of concern and may be exacerbated by anthropomorphic factors occurring adjacent to the wetland habitat of the species. Given the low numbers of plants found at each site, even minor changes in the habitat of the species could result in local extirpation. Loss of any known sites could result in a serious protraction of the species' range. However, the most immediate and severe of the threats to this species (i.e., ditching of the Laboundsky Pond site, and encroachment of aggressive vegetative competitors) have been curtailed or are being actively managed by The Nature Conservancy at one New Jersey site and by the Delaware Division of Fish and Wildlife and Delaware Natural Heritage Program at the Assawoman Pond, Delaware site. Based on threats of a high magnitude but low imminence, we retained an LPN of 5 for this species. *Digitaria pauciflora* (Florida pineland crabgrass)—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. *Digitaria pauciflora* occurs in the pineland/prairie ecotones and prairies in Miami-Dade and Monroe Counties, Florida. Pine rocklands in Miami-Dade County have largely been destroyed by residential, commercial, and urban development and agriculture. Most remaining habitat has been negatively altered, and this species has been extirpated from much of its historical range. Two large occurrences remain within Everglades National Park and Big Cypress National Preserve. While privately owned pine rocklands and prairies are at risk to development, the plants on Federal lands are protected from this threat. This grass is threatened by habitat loss and habitat degradation due to fire suppression, the difficulty of applying prescribed fire to pine rocklands, and exotic plants. Since the only remaining populations are on lands managed by the National Park Service, the threats of fire suppression and exotics are somewhat reduced. The nearby presence of the exotic Old World climbing fern is of particular concern due to its ability to rapidly spread. In Big Cypress National Preserve, plants are currently threatened by off-road vehicle use. Hydrology has been altered within Long Pine Key due to artificial drainage, which lowered ground water, and construction of roads, which either impounded or diverted water. Regional water management intended to restore the Everglades has the potential to have a negative effect on the pinelands of Long Pine Key, where a large population occurs. At this time, it is not known whether Everglades restoration will have a positive or negative effect. This narrow endemic may be vulnerable to catastrophic events and natural disturbances, such as hurricanes. Sea level rise will likely be a factor over the long-term. Overall, the magnitude of threats is considered to be high because this species has been extirpated from all pine rocklands in Miami-Dade County outside of Everglades National Park. However, the more significant threats are not currently occurring (Old World climbing fern is not yet in the area where the species is found and the effects of Everglades restoration are unknown at this time), and are, thus, nonimminent. Therefore, we assigned an LPN 5 for this species. *Dubautia imbricata* ssp. *imbricata* (Naenae)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Dubautia plantaginea* ssp. *magnifolia* (Naenae)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Dubautia waialealae* (Naenae)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Echinomastus erectocentrus* var. *acunensis* (Acuna cactus)—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information contained in our files and the petition we received on October 30, 2002. *Erigeron lemmonii* (Lemmon fleabane)—The following summary is based on information contained in our files and the petition we received in July 1975. The species is known from one site in a canyon in the Fort Huachuca Military Reservation of southeastern Arizona. As of 2006, approximately 950 plants were known from this site. The population had not been inventoried since the 1990s, but a complete assessment was completed in 2006; approximately 500 more plants were located and occupied habitat encompasses about 1 square kilometer. The threats to this species are from catastrophic wildfire in the canyon and on-going drought conditions. We do not know if this species has any adaptations to fire. Due to its location on cliffs, we suspect that fires that may have occurred at more regular intervals and burned at low intensities may have had little to no effect on this species. It may be that the fire intensity and associated heat is only high enough to damage or kill plants on adjacent cliffs, especially near the ground, when an extended absence results in an accumulated fuel load. Even with an accumulated fuel load, the plants that are much higher on the cliff face probably would not be affected. Ft. Huachuca Military Reservation has indicated a willingness to develop a conservation agreement for this species. The magnitude of threats is moderate, because we believe that not all of the population would be adversely affected by a wildfire or drought. The threats are imminent because the likelihood of a fire is high due to the ongoing drought. We retained an LPN of 8 for this species due to moderate, imminent threats. *Eriogonum codium* (Umtanum Desert buckwheat)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. This species is a long-lived, slow-growing, woody perennial plant that forms low dense mats. The known range of the species is a single location along a ridge on federally owned land in the Hanford National Monument in Washington State. Although it is found exclusively on exposed basalt from the Lolo Flow of the Wanapum Basalt Formation, it is unknown if the close association is related to the chemical composition or physical characteristics of the bedrock or other factors. Individual plants may exceed 100 years of age, based on counts of annual growth rings of dead plants. After its discovery in 1995, the population was counted in 1997. This count reported 5,228 living individuals, and by 2005 the figure had dropped to 4,418, representing a 15 percent decline in the population over eight years. A draft population viability analysis based on 9 years of demographic data was recently completed. This study determined that that there is little or no risk of a population decline greater than 90 percent within the next 100 years, but there is a 72 percent chance of a decline of 50 percent over the next century. The major threats to the species are wildfire, fire-fighting activities, trampling, and invasive weeds. However, the relationship between the current decline in population numbers and the known threats is not clearly understood at this time. With the possible exception of wildfire, the observed decline in population numbers and recruitment since 1997 is not directly attributable to the currently known threats. Because the population is small, limited to a single site, and sensitive to fire and disturbance, the species remains vulnerable to the identified threats. The magnitude of threats is high, because, given the limited range of the species and the degree of uncertainty about its habitat and the cause of its declines, any of the threats could adversely affect its continued existence. The threats are both ongoing and imminent in nature. Because the species continues to be vulnerable to these threats, we assigned an LPN of 2 to this species. *Eriogonum kelloggii* (Red Mountain buckwheat)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Red Mountain buckwheat is a perennial herb endemic to serpentine habitat of lower montane forests found between 1,900 and 4,100 feet. Its distribution is limited to the Red Mountain and Little Red Mountain areas of Mendocino County, California, where it occupies 50 acres and 900 square feet, respectively. Occupied habitat at Red Mountain is scattered over 4 square miles. Total population size is estimated at between 20,000 and 30,000 plants, which occur in 44 polygons. Intensive monitoring of permanent plots on three study sites in Red Mountain suggests considerable annual variation in plant density and reproduction, but no discernable population trend was evident in two of three study sites. One study site showed a 65 percent decline in plant density over 11 years. The primary threat to this species is the potential for surface mining for chromium and nickel. Virtually the entire distribution of Red Mountain buckwheat is either owned by mining interests, or is covered by existing mining claims, that are not currently active. Surface mining would destroy habitat suitability for this species. The species is also believed threatened by tree and shrub encroachment into its habitat, in absence of fire. The species distribution by ownership is described as follows: Federal (Bureau of Land Management)—69 percent (this portion of the distribution was recently included in the South Fork Eel River Wilderness Area, managed by BLM); State of California—1 percent; and private—30 percent. Given the magnitude

(high)and immediacy (nonimminent) of the threat to the small, scattered populations, and its taxonomy (species), we assigned an LPN of 5 to this species. *Festuca hawaiiensis* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species is a cespitose (growing in dense, low tufts) annual found in dry forest on the island of Hawaii, Hawaii. *Festuca hawaiiensis* is known from four populations totaling approximately 1,000 individuals in and around the Pohakuloa Training Area on the island of Hawaii. Historically, this species was also found on Hualalai and Puu Huluhulu on Hawaii and possibly Ulupalakua on Maui, but it no longer occurs at these sites. *Festuca hawaiiensis* is threatened by pigs, goats, mouflon, and sheep that degrade and destroy habitat; fire; military training activities; and nonnative plants that outcompete and displace it. Feral pigs, goats, mouflon, and sheep have been fenced out of a portion of the populations of *F. hawaiiensis,* and nonnative plants have been reduced in the fenced areas. Firebreaks have been established at two populations. However, these threats are imminent because they are not controlled and are ongoing in the remaining, unfenced populations. The threats are of a high magnitude because they could adversely affect *F. hawaiiensis* resulting in direct mortality or reduced reproductive capacity. Therefore, we retained an LPN of 2 for this species. *Festuca ligulata* (Guadalupe fescue)—The following summary is based on information from our files and in the petition we received in 1975. Guadalupe fescue is a member of the Poaceae (Grass family). This species is currently only known from higher elevations in the Chisos Mountains in the Big Bend Area of Texas (one population) and adjacent Coahuila, Mexico (two populations). The population in Big Bend National Park is bisected by a trail and subject to occasional trampling by horses and hikers. The magnitude of threats for Guadalupe fescue is moderate to low because of population monitoring and trail operation by the National Park Service. Based on monitoring results, threats to the U.S. population are nonimminent because of conservation actions at Big Bend National Park to address threats to the species. Thus, we assign an LPN of 11 to this species. *Gardenia remyi* (Nanu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Nanu is a tree found in mesic to wet forest on islands of Kauai, Molokai, Maui, and Hawaii, Hawaii. *Gardenia remyi* is known from 19 populations totaling between 77 and 104 individuals throughout its range. This species is threatened by pigs, goats, and deer that degrade and destroy habitat and possibly prey upon the species, and by nonnative plants that outcompete and displace it. It is also threatened by landslides on the island of Hawaii. This species is represented in an *ex situ* collection. Feral pigs have been fenced out of the west Maui populations of *G. remyi,* and nonnative plants have been reduced in those areas. However, these threats are not controlled and are ongoing in the remaining, unfenced populations, and are, therefore, imminent. In addition, the threat from goats and deer is ongoing and imminent, because no goat or deer control measures have been undertaken for any of the populations of *G. remyi* . All of the threats are of a high magnitude because they are significant enough that they could adversely affect the species resulting in direct mortality or reduced reproductive capacity. Therefore, we retained an LPN of 2 for this species. *Geranium hanaense* (Nohoanu)—See above in “ * Summary of Listing Priority Changes in Candidates * .” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Geranium hillebrandii* (Nohoanu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Geranium hillebrandii* is a decumbent subshrub found in bogs on Maui, Hawaii. Previously known from two populations totaling approximately 1,000 to 2,000 individuals, it is currently known, as a result of more thorough surveys, from three populations totaling 10,000 individuals. *Geranium hillebrandii* is moderately threatened by pigs that degrade and destroy habitat, and by nonnative plants that outcompete and displace it. Conservation measures taken to control feral pigs and nonnative plants reduce the impact of these threats to *G. hillebrandii* ; however, continued monitoring will be necessary to keep the areas threat-free. The threats from feral pigs and nonnative plants are, therefore, of a moderate magnitude to this species; however, these threats are imminent because they are ongoing in half of the populations. Therefore, we retained an LPN of 8 for this species. *Geranium kauaiense* (Nohoanu)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Gonocalyx concolor* (no common name)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *Gonocalyx concolor* is a small evergreen epiphytic shrub. Currently, *G. concolor* is known only from the dwarf or elfin forest type in the Carite Commonwealth Forest (Cerro La Santa), located in the Sierra de Cayey in the municipalities of Guayama, Cayey, Caguas, San Lorenzo, and Patillas in southeastern Puerto Rico. The population previously reported in the Caribbean National Forest is apparently no longer extant. The limited distribution (i.e., the entire population located at one site) and low population numbers (approximately 172 individuals) of *G. concolor,* habitat destruction from construction of roads and telecommunication towers, certain forest management practices such as the development and maintenance of trails, and potential for catastrophic natural events threaten this species. *Gonocalyx concolor* has a restricted distribution that renders this species vulnerable to natural (e.g., hurricanes, landslides) or manmade (e.g., telecommunication towers, forest management practices) threats to its habitat and population, thus making the threat magnitude high. The Puerto Rico Department of Natural and Environmental Resources developed a management plan for the Carite Commonwealth Forest in 1976. This management plan includes the protection and conservation of species classified under PRDNER regulations as critical, threatened, or endangered. Actions that may impact such species are generally scrutinized, and measures to minimize or avoid impacts to these species are recommended and implemented, if deemed appropriate. Thus, the immediacy of the threats is nonimminent. Therefore, we have assigned an LPN of 5 for the *Gonocalyx concolor* . *Hazardia orcuttii* (Orcutt's hazardia)—The following summary is based on information contained in our files and the petition we received on March 8, 2001. *Hazardia orcuttii* is an evergreen shrubby species in the Asteraceae (sunflower family). The erect shrubs are 50-100 centimeters (20-40 inches) high. The only known extant native occurrence of this species in the U.S., is in the Manchester Conservation Area in northwestern San Diego County, California. This site is managed by Center for Natural Lands Management. *Hazardia orcuttii* also occurs at a few coastal sites in Mexico, where it has no conservation standing in Mexico. The occurrences in Mexico are threatened by the rapid rate of coastal development from Tijuana to Ensenada. There are approximately 600 native plants remaining in the U.S. and the population in Mexico is estimated at approximately 1,300 plants. Apparent threats to the U.S. population include pedestrian trampling, on- and off-leash dogs, and creation of bicycle trails near *Hazardia orcuttii* plants. Competition from invasive nonnative plants may pose a threat to the reproductive potential of this species. Another significant threat is the apparently low reproductive output of the species. This stems from a recent study that found that 95 percent of the flowers examined were damaged by insects or fungal agents or aborted prematurely, and that insects or fungal agents damaged 50 percent of the seeds produced. The threats are of a high magnitude because they are significant enough that they could adversely affect the continued existence of the species. Overall, the threats are nonimminent since the species occurs in a protected area where some of the threats are not occurring since they are managed. Therefore, we assigned this species a listing priority of 5. *Hedyotis fluviatilis* (Kamapuaa)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Kamapuaa is a scandent shrub found in mixed shrubland to wet lowland forest on Oahu and Kauai, Hawaii. This species is known from 12 populations totaling 800 to 1,200 individuals throughout its range. *Hedyotis fluviatilis* is threatened by pigs and goats that degrade and destroy habitat, and by nonnative plants that outcompete and displace it. All of the threats occur range-wide and no efforts for their control or eradication are being undertaken. We retained an LPN of 2 because the severity of the threats is high and are ongoing so are imminent. *Helianthus verticillatus* (Whorled sunflower)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Hibiscus dasycalyx* (Neches River rose-mallow)—The following summary is based on information from our files. No new information was provided in the petition received on May 11, 2004. Neches River rose-mallow is a perennial woody herb growing 1-2 meters tall with one or more stems per clump and white flowers 7.5-15 centimeters wide, consisting of five 5-10 centimeter-long white petals with deep red or purple at the base. The Neches River rose-mallow appears to be restricted to wetlands, or those portions of wetlands that are exposed to open sun and normally hold standing water early in the growing season, with water levels dropping during late summer and fall. This species appears to have community dominance within the narrow band between high and low water levels in wetlands exposed to open sun. However, historical habitat has been affected by drainage or filling of floodplain depressions and oxbows, stream channelization, road construction, timber harvesting, agricultural activities (primarily mowing and grazing), and herbicide use. Threats that continue to potentially affect the species include wetland alteration, herbicide use, grazing, mowing during the species' growing and flowering period, and genetic swamping by other *Hibiscus* species. A 1995 status survey of 10 counties resulted in confirmation or discovery of the species in only three sites, but in three separate counties and three different watersheds, suggesting a relatively wide historical range. These three populations—Ponta site in Cherokee County, Lovelady in Houston County, and Highway 94 in Trinity County—were all within highway rights-of-way and somewhat protected by a management agreement between Texas Parks and Wildlife Department and Texas Department of Transportation. Because these sites were still vulnerable to herbicides and adjacent agricultural activities, they supported relatively low population numbers: In 2005, Ponta (Highway 204) had declined to 0 plants; Lovelady (Highway 230), to 0 plants; and Highway 94, to 20 plants. Continued surveys for *H. dasycalyx* have resulted in new populations. About 300 plants were found on land owned by the Temple-Inland Corporation in east Trinity County. A Candidate Conservation Agreement was developed for this site, but smaller plant numbers have been seen in recent years, possibly due to changes in the wetland's hydrology. Another site discovered on land previously owned by Champion International Corporation (near White Rock Creek in west Trinity County) once supported 300-400 plants. However, the status of this population is currently unknown due to a change in ownership. In west Houston County, a population of 300 to 400 plants discovered on private land has been purchased by the Natural Area Preservation Association, a land trust organization, in order to protect this land in perpetuity. In east Houston County, a population discovered in Compartment 55 in Davy Crockett National Forest numbered over 1,000 in 2006. Davy Crockett National Forest represents the only public land within the range of *H. dasycalyx* . In 2000, nearly 800 plants were introduced into Compartments 16 and 20 of Davy Crockett National Forest as part of a reintroduction effort. One population has retained high numbers (350 in 2006), but the second was affected by a change in hydrology and has declined to 50 plants in 2006. In 2004, 200 plants were placed in a wetland in Compartment 11 of Davy Crockett National Forest. This attempt has not been successful; only 10 plants were seen in 2006 and all showed evidence of wilt and insect predation. Four unconfirmed reports of the Neches River rose-mallow in Davy Crockett National Forest will be investigated in 2008. The threats to the species continue to be of a high magnitude because they can severely affect the survival and reproductive capacity of the species. Overall the threats are nonimminent since they are not currently affecting or likely to affect the majority of the populations of this species in the immediate future. Thus, we have retained an LPN of 5 for the Neches River rose-mallow. *Indigofera mucronata keyensis* (Florida indigo)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Florida indigo occurs in coastal rock barrens, ecotone rock barren areas, and scraped areas mimicking rock barren habitat. Based upon available data, there are 12 occurrences of Florida indigo on eight islands in the upper and middle Florida Keys, in Monroe County; half of the original occurrences in the Keys are now extirpated, as are historic occurrences on mainland Florida in Collier and Miami-Dade Counties. Most occurrences are small; total population size is probably close to 3,000 individuals. One of the largest occurrences (500 individuals) is on private lands. Florida indigo is threatened by habitat loss, even on public lands, as well as habitat loss and degradation from exotic plants on all sites. Shading by hardwoods is a problem at approximately half of the sites. Planned restoration activities, illegal dumping, and trespass have also been identified as threats. Florida indigo is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges; however, these factors may also work to maintain coastal rock barren habitat in the long-term. Sea level rise is considered a long-term threat that will continue. Overall, the threats are moderate in magnitude because most populations occur on public land where there is some work being done to manage for this species. The threats are ongoing, and therefore, imminent. Thus, we assigned an LPN of 9 to this plant variety. *Ivesia webberi* (Webber ivesia)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Ivesia webberi* is a low, spreading, perennial herb that occurs very infrequently in Lassen, Plumas, and Sierra Counties, California, and in Douglas and Washoe Counties, Nevada. The species is restricted to sites with sparse vegetation and shallow, rocky soils composed of volcanic ash or derived from andesitic rock. Occupied sites generally occur on mid-elevation flats, benches, or terraces on mountain slopes above large valleys along the transition zone between the eastern edge of the northern Sierra Nevada and the northwestern edge of the Great Basin Desert. Currently, the global population is estimated at approximately 4.8 million individuals at 15 known sites. The Nevada sites support nearly 98 percent of the total number of individuals (4.7 million) on about 30 acres of occupied habitat. The California sites are larger in area, totaling about 156 acres, but support fewer individuals (approximately 115,000). The primary threats to Webber ivesia include urban development, authorized and unauthorized roads, off-road vehicle activities and other dispersed recreation, livestock grazing and trampling, fire and fire suppression activities including fuels reduction and prescribed fires, and displacement by noxious weeds. Despite the high numbers of individuals, observations in 2002 and 2004 confirmed that direct and indirect impacts to the species and its habitat, specifically from urban development and off-highway vehicle activity remain high and are likely to increase. The threats are therefore of a high magnitude. However, the U.S. Forest Service has committed to develop a conservation strategy and monitoring program to protect this species on National Forest lands, and the State of Nevada has listed the species as critically endangered, which provides a mechanism to track future impacts on private lands. In addition, both the Forest Service and State of Nevada have agreed to coordinate closely on all activities that may affect this species. For these reasons, we determined that the threats to Webber ivesia are nonimminent and we maintained an LPN of 5 for this species. *Joinvillea ascendens* ssp. *ascendens* (Ohe)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Ohe is an erect herb found in wet to mesic *Metrosideros polymorpha* - *Acacia koa* (ohia-koa) forest on the islands of Kauai, Oahu, Molokai, Maui, and Hawaii, Hawaii. *Joinvillea ascendens* ssp. *ascendens* is known from 37 populations totaling approximately 200 individuals throughout its range. Plants are typically found as only one or two individuals, with miles between populations. This subspecies is threatened by pigs, goats, and deer that degrade and destroy habitat, and by nonnative plants that outcompete and displace native plants. Predation by pigs, goats, deer, and rats is a likely threat to this species. Seedlings have rarely been observed in the wild. Seeds germinate in cultivation, but most die soon thereafter. It is uncertain if this rarity of reproduction is typical of this subspecies, or if it is related to habitat disturbance. Feral pigs have been fenced out of a few of the populations of *J. ascendens* ssp. *ascendens,* and nonnative plants have been reduced in a few populations that are fenced. However, these threats are not controlled and are ongoing in the remaining, unfenced populations. The threats to this species are of high magnitude because habitat degradation, nonnative plants and predation could affect the ability of the species to survive. The threats are on-going, and thus are imminent. Therefore, we retained an LPN of 3 for this subspecies. *Keysseria erici* (no common name)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Keysseria helenae* (no common name)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Korthalsella degeneri* (Hulumoa)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Hulumoa is a parasitic subshrub found on two species of native trees, *Sapindus oahuensis* and *Nestegis sandwicensis* , only in diverse mesic forests on Oahu, Hawaii. Recent surveys indicate that the species is known only from one population of 900 to 1,000 individuals in Makua Valley. *Korthalsella degeneri* is threatened by pigs and goats that degrade and destroy habitat, fire, and nonnative plants that outcompete and displace native plants. Goats and pigs may prey upon the plant species *K. degeneri* is dependent on. Goats and pigs have been partially fenced out of the area in Makua Valley where *K. degeneri* currently occurs, but some goats are still present. Fires resulting from military activities have been minimized but not completely eliminated. Threats continue to be of a high magnitude and imminent, because they are ongoing and because of the potential for the elimination of the only known population by a single fire event. Therefore, we retained an LPN of 2 for this species. *Labordia helleri* (Kamakahala)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Labordia pumila* (Kamakahala)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Leavenworthia crassa* (Gladecress)—The following information is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This species of gladecress is a component of glade flora, occurring in association with limestone outcroppings. *Leavenworthia crassa* is endemic to a 13-mile radius area in north central Alabama in Lawrence and Morgan Counties, Alabama, where only six populations of this species are documented. Glade habitats today have been reduced to remnants fragmented by agriculture and development. Populations of this species are now located in glade-like areas exhibiting various degrees of disturbance including pastureland, roadside rights-of-way, and cultivated or plowed fields. The most vigorous populations of this species are located in areas which receive full, or near full, sunlight with limited herbaceous competition. The magnitude of threat is high for this species, because with the limited number of populations, the threats could result in direct mortality or reduced reproductive capacity of the species. The immediacy of threat is nonimminent since there are no known projects planned that would destroy any sites and the species is able to withstand some disturbance. Thus, we assigned an LPN of 5 to this species. *Leavenworthia texana* (Texas golden gladecress)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. The Texas golden gladecress is a small annual member of the mustard family, with deep, yellow petals only 7-10 mm long; flowering is February through March. The gladecress occurs only on the Weches outcrops of east Texas in San Augustine and Sabine counties. The Weches geologic formation consists of a layer of calcareous sediment, lying above a layer of glauconite clay deposited up to 50 million years ago. Erosion of this complex has produced topography of steep, flat-topped hills and escarpments, as well as the unique ecology of Weches glades: islands of thin, loamy, seepy, alkaline soils that support open-sun, herbaceous, and highly diverse and specialized plant communities. The gladecress was historically recorded at eight sites, all in a narrow region along north San Augustine and Sabine counties, following the Weches formation. All sites are on private land. Two historic locations have been lost to glauconite mining. A nearby glauconite mine has probably altered the water regime at another historic site. Two sites are currently closed to visitors, so biologists could not evaluate the number of plants they could support. However, the Sabine County site supported 1000 plants within 9 square meters in 2007. The Tiger Creek site in San Augustine County (less than 0.1 ha in size) was found to have about 200 gladecress in 2007. The Kardell site (less than 9 square meters) has supported 400-500 plants in past years, but none in 2005. An introduced population in Nacogdoches County numbered about 1000 within an area of about 18 square meters in 2007. Historic gladecress habitat has been affected by highway construction, residential development, conversion to pasture and cropland, widespread use of herbicide, overgrazing, and glauconite mining. However, the primary threat to existing gladecress populations is the invasion of nonnative and weedy shrubs and vines (primarily Macartney rose ( *Rosa bracteata* ) and Japanese honeysuckle ( *Lonicera japonica* )). All known sites are undergoing severe degradation by the incursion of nonnative shrubs and vines, which restrict both growth and reproduction of the gladecress. Brushclearing carried out in 1995 resulted in the reappearance of gladecress after a 10-year absence at one site. However, nonnative shrubs have again invaded this area. More effective control measures, such as burning and selective herbicide use, need to be tested and monitored. The small number of known sites also makes the gladecress vulnerable to extreme natural disturbance events. A severe drought in 1999 and 2000 had a pronounced adverse effect on gladecress reproduction. Since the threat from nonnative plants severely affects all known sites, the magnitude is high. The threats are imminent since they are ongoing. Therefore, we retain an LPN of 2 for the Texas golden gladecress. *Lesquerella globosa* (Desvaux) Watson (Short's bladderpod)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Short's bladderpod is a perennial member of the mustard family that occurs in Indiana (1 location), Kentucky (6 locations), and Tennessee (18 locations). It grows on steep, rocky, wooded slopes, talus areas, along cliff tops and bases, and on cliff ledges. It is usually associated with south to west facing calcareous outcrops adjacent to rivers or streams. Road construction and road maintenance have played a significant role in the decline of *Lesquerella globosa* . Specific activities that have affected the species in the past and potentially threaten it now, include bank stabilization, herbicide use, mowing during the growing season, grading of road shoulders, and road widening or repaving. Sediment deposition during road maintenance or from other activities also potentially threatens the species. Interruption of natural processes that maintained habitat suitability and competition from invasive nonnative vegetation necessitates active habitat management at many locations. Given the number of threats that could adversely affect the ability of this species to survive, the magnitude of threat is high. Based upon the number of populations and the anticipation that most of these threats will not be realized in the next 1-2 years, the threats are nonimminent. We have therefore assigned an LPN of 5 to this species. *Linum arenicola* (Sand flax)—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. Based upon available data, there are 10 extant occurrences of sand flax; 11 others are extirpated or destroyed. Only small and isolated occurrences remain in a restricted range of southern Florida and the Florida Keys. Habitat loss and degradation due to development is a major threat—most of the remaining occurrences are on private land or non-conservation public land. However, much of the pine rocklands on Big Pine Key are protected. Nearly all remaining populations are threatened by fire suppression, difficulty in applying prescribed fire, road maintenance activities, exotic species, or illegal dumping. However, some efforts are underway to use prescribed fire and control exotics on conservation lands. Sand flax is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges; Hurricane Wilma inundated most of its habitat on Big Pine Key in 2005, and plants were not found 8-9 weeks post-storm. We also consider sea level rise to be a substantial threat that will reduce the extent of upland habitats. Due to the small and fragmented nature of the current population, stochastic events, disease, or genetic bottlenecks may strongly affect this species. Reduced pollinator activity and suppression of pollinator populations from pesticides used in mosquito control and decreased seed production due to increased seed predation in a fragmented wildland-urban interface may also affect sand flax; however, not enough information is known on this species' reproductive biology or life history to assess these potential threats. Viability is uncertain. Overall, the magnitude of threats is high and most threats are ongoing and thus are imminent. Therefore, we assigned an LPN of 2 to this species. *Linum carteri* var. *carteri* (Carter's small-flowered flax)—The following summary is based on information in our files. No new information was provided in the petition we received on May 11, 2004. This plant occupies open sites in pinelands of Miami-Dade County, Florida. Occurrences with fewer than 100 individuals are located on three county-owned preserves. An occurrence with more than 100 plants is on a non-conservation site owned by the U.S. government. The 10 existing occurrences are small and vulnerable to habitat loss, which is exacerbated by habitat degradation due to fire suppression, the difficulty of applying prescribed fire to pine rocklands, and threats from exotic plants. Remaining habitats are fragmented. Non-compatible management practices are also a threat at most protected sites; several sites are mowed during the flowering and fruiting season. The species is vulnerable to natural disturbances, such as hurricanes, tropical storms, and storm surges. This species exists in such small numbers at so few sites, that it may be difficult to develop viable occurrences on the available conservation lands. Although no population viability analysis has been conducted for this plant, indications are that existing occurrences are at best marginal and none are truly viable. As a result, the magnitude of threats is high. Because no viable populations of this plant exist, threats are imminent, so we assigned an LPN of 3 to this plant variety. *Lysimachia daphnoides* (Lehua makanoe)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Melicope christophersenii* (Alani)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Melicope christophersenii* is a long-lived perennial shrub or tree found in *Metrosideros tremuloides* montane wet forest in the Waianae Mountains on Oahu, Hawaii. Currently, this species is known from one wide-spread area totaling approximately 300 individuals. *Melicope christophersenii* is threatened by feral pigs that may eat it and degrade and destroy habitat, and nonnative plants that compete for light and nutrients. The black twig borer may pose a threat to *M. christophersenii* because it is known to infest other species of *Melicope* on Oahu and it occurs throughout the Waianae Mountains. Only a few individuals may benefit from fencing that the U.S. Army has constructed. The threats to *M. christophersenii* from feral pigs, nonnative plants, and the black twig borer are imminent and of a high magnitude because they represent severe threats to the species throughout its limited range and they are ongoing; therefore, we retained an LPN of 2 for this species. *Melicope degeneri* (Alani)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Melicope hiiakae* (Alani)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Melicope makahae* (Alani)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Melicope makahae* is a shrub or shrubby tree found in mesic forest in the Waianae Mountains on Oahu, Hawaii. Currently *M. makahae* is known from two populations on two discrete ridges, totaling approximately 200 individuals. This species is threatened by goats and pigs that degrade and destroy habitat, and likely prey upon the plants, and nonnative plants that compete for light and nutrients. The black twig borer is a likely threat to *M. makahae,* because it is known to infest other species of *Melicope* on Oahu and it occurs throughout the Waianae Mountains. Portions of both populations are within fenced and managed areas; however, the threats to *M. makahae* from goats, pigs, nonnative plants, and the black twig borer are of a high magnitude because they pose a severe threat to all unmanaged individuals range-wide. The threats are imminent, since they are ongoing. Therefore, we retained an LPN of 2 for this species. *Melicope paniculata* (Alani)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Melicope puberula* (Alani)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Myrsine fosbergii* (Kolea)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Myrsine fosbergii* is a branched shrub or small tree found in cloud swept ridges and wet forest on Kauai and Oahu, Hawaii. This species is currently known from 9 populations totaling approximately 56 individuals on Kauai and from 8 populations totaling between 73 and 83 individuals in the Koolau mountains of Oahu. *Myrsine fosbergii* is threatened by feral pigs and goats that degrade and destroy habitat and may prey upon the plant, and nonnative plants that compete for light and nutrients. Although there are plans to fence and remove ungulates from the Helemano area of Oahu, which may benefit this species, no conservation measures have been taken to date to alleviate these threats for this species. Feral pigs and goats are found throughout the known range of *M. fosbergii,* as are nonnative plants. The threats from feral pigs, goats, and nonnative plants are of a high magnitude because they pose a severe threat throughout the limited range of this species and are on-going and therefore imminent. We retained an LPN of 2 for this species. *Myrsine mezii* (Kolea)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Myrsine vaccinioides* (Kolea)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Myrsine vaccinioides* is a small branched shrub found in shrubby bogs on Maui, Hawaii. This species is found scattered throughout the bogs of west Maui, totaling fewer than 1,000 individuals. *Myrsine vaccinioides* is threatened by feral pigs that degrade and destroy habitat, and nonnative plants that compete for light and nutrients. Pig exclusion fences protect some individuals of this species, and nonnative plants have been reduced around some individuals that are fenced. However, these ongoing conservation efforts benefit only a small number of the known individuals. Further, nonnative plants will probably never be completely eradicated because new propagules are constantly being dispersed into the fenced areas from surrounding, unmanaged lands. The threats are of a high magnitude because they pose a severe threat throughout the limited range of the species and are ongoing, and thus imminent. Therefore, we retained an LPN of 2 for this species. *Narthecium americanum* (Bog asphodel)—The following summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. Bog asphodel is a perennial herb that is found in savannah areas, usually with water moving through the substrate, as well as in sandy bogs along streams and rivers. The historic range of bog asphodel include New York, New Jersey, Delaware, North Carolina, and South Carolina, but is now only found within the Pine Barrens region of New Jersey. As an obligate wetland species, *N. americanum* is threatened by changes in hydrology, loss of habitat due to filling or draining of wetlands, flooding as a result of reservoir construction, and conversion of natural wetlands to commercial cranberry bogs. This species occurs in the Pine Barrens region, and the Pinelands Commission issues the State-assumed Clean Water Act Section 404 permits. The Pinelands Commission grants wetland exemptions to cranberry production and other agricultural uses. Illegal wetland filling is occurring. For example, a cranberry expansion was illegally completed without a State permit. In addition, activities not needing State or federal permits are occurring in uplands that are indirectly affecting the wetlands. Natural succession of vegetation in wetlands supporting bog asphodel from emergent (herbaceous) to forested wetlands may also be contributing to the decline of the species. Suppression of natural wildfires that would retard succession or created open wetland savannahs may be a factor in the decline of the species. Other factors adversely affecting *N. americanum* include trampling, erosion, and siltation caused by recreationists on foot or using off-road vehicles. Approximately 70 percent of known extant populations occur on State-owned lands. We are working with the New Jersey Department of Environmental Protection to abate known moderate threats at these sites from recreational use and erosion. Approximately 30 percent of the known extant sites are on privately owned lands, many of which are threatened by habitat degradation from on-site or adjacent residential or commercial development. Overall, the threats are moderate due to the protection provided by the State on State-owned lands. The threats are ongoing and therefore are imminent. Therefore, we retained an LPN of 8 for this species. *Nothocestrum latifolium* (Aiea)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Aiea is a small tree found in dry to mesic forest and diverse mesic forests on Kauai, Oahu, Maui, Molokai, and Lanai, Hawaii. *Nothocestrum latifolium* is known from 19 populations totaling fewer than 1,100 individuals. This species is threatened by feral pigs, goats and axis deer that degrade and destroy habitat and may prey upon it, by nonnative plants that compete for light and nutrients, and by the loss of pollinators that negatively affect the reproductive viability of the species. Ungulates have been fenced out of some areas where *N. latifolium* currently occurs, and nonnative plants have been reduced in some populations that are fenced. However, these ongoing conservation efforts for this species benefit only a few of the known populations. The threats are not controlled and are ongoing in the remaining unfenced populations. In addition, little regeneration is observed in this species. Therefore, the threats are of a high magnitude since they are severe enough to affect the continued existence of the species. The threats are imminent since they are ongoing. Therefore, we retained an LPN of 2 for this species. *Ochrosia haleakalae* (Holei)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Holei is a tree found often on lava in dry to mesic forest on the islands of Hawaii and Maui, Hawaii. This species is currently known from 9 wild and outplanted populations totaling fewer than 500 individuals. *Ochrosia haleakalae* is threatened by fire; by feral pigs, goats, and cattle that degrade and destroy habitat and may directly prey upon holei; and by nonnative plants that compete for light and nutrients. Feral pigs, goats, and cattle have been fenced out of one wild and one outplanted population on private lands on the island of Maui and one outplanted population in Hawaii Volcanoes National Park on the island of Hawaii. Nonnative plants have been reduced in the fenced areas. No known conservation measures have been taken to date for the other populations on the islands of Maui and Hawaii. The threat from fire is of a high magnitude and imminent because no control measures have been undertaken to address this threat that could adversely affect *O. haleakalae* as a whole. The threats from feral pigs, goats, and cattle are ongoing to the unfenced populations of *O. haleakalae.* The threat from nonnative plants is ongoing and imminent, and of a high magnitude to the wild populations on both islands since this threat has the potential to adversely affect the continued existence of this species. Therefore, we retained an LPN of 2 for this species. *Pediocactus peeblesianus* var. *fickeiseniae* (Fickeisen plains cactus)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. The Fickeisen plains cactus is a small cactus known from the Gray Mountain vicinity to the Arizona strip in Coconino and Mohave counties, Arizona. The cactus grows on exposed layers of Kaibab limestone on canyon margins and well-drained hills in Navajoan desert or grassland. In 1999, Arizona Game and Fish Department noted 23 occurrences of the species, including historical ones. The species is located on Bureau of Land Management, U.S. Forest Service, tribal, and possibly State lands. Recent reports from the Bureau of Land Management and Navajo Nation describe populations of the species as being in decline. The main human-induced threats to this cactus are off-road vehicles and trampling associated with livestock grazing. Monitoring data has detected mortality associated with livestock grazing. Illegal collection of this species has been noted in the past, but we do not know if it is a continuing threat. The populations that have been monitored have been affected, in part, by the continuing drought. There has been very low recruitment, and rabbits and rodents have consumed adult plants since there is reduced forage available during these dry conditions. The threats are high magnitude because they adversely affect the plant resulting in direct mortality or reduced reproductive capacity. The threats are imminent because they are ongoing. The LPN for this plant variety remains a 3. *Penstemon debilis* (Parachute beardtongue)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Penstemon debilis* is an extremely rare plant endemic to oil shale outcrops on the Roan Plateau escarpment in Garfield County, Colorado. Total estimated number of plants is approximately 3800 individuals. About 62 percent of the plants are on private land owned by Occidental Petroleum. Most of the remaining 38 percent occur in one population on Bureau of Land Management land that will soon be open to leasing under a new Resource Management Plan amendment. Pressure to develop energy reserves in this area is intense. Threats include habitat destruction caused by heavy equipment use of access roads through plant populations. These threats are high magnitude because they present a significant threat to the parachute beardtongue resulting in direct mortality or reduced reproductive capacity. We maintained an LPN 2 for this species based on a dramatic increase in the intensity of energy exploration in the last three years along the Roan Plateau escarpment. *Penstemon scariosus* var. *albifluvis* (White River beardtongue)—The following summary is based on information contained in our files and the petition we received on October 27, 1983. The White River beardtongue is restricted to calcareous soils derived from oil shale barrens of the Green River Formation in the Uinta Basin of northeastern Utah and adjacent Colorado. There are 14 occurrences known in Utah and 1 in Colorado. Most of the occupied habitat of the White River beardtongue is within developed and expanding oil and gas fields. The location of the species' habitat exposes it to destruction from road, pipeline, and well-site construction in connection with oil and gas development. Recreational off-road vehicle use, heavy grazing by livestock, and wildlife and livestock trampling are additional threats. Based on current information, we retained an LPN of 6 because these nonimminent threats present a significant risk to this plant variety. *Peperomia subpetiolata* (Ala ala wai nui)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Ala ala wai nui is a short-lived perennial herb found in montane mesic forest on Maui, Hawaii. This species is known from one occurrence consisting of two subpopulations on windward east Maui, totaling 23 individuals. Further study of the occurrence indicates that the plants may actually represent clones of only six genetically distinct individuals. *Peperomia subpetiolata* is threatened by feral pigs that may eat this plant and degrade and destroy habitat, and by nonnative plants that compete for light and nutrients. Individuals that occur within the Waikamoi Preserve may benefit from fencing and management actions; however, all of the threats occur range-wide. We retained an LPN of 2 because the threats are of a high magnitude because they pose a significant threat to the species resulting in direct mortality or reduced reproductive capacity, and are ongoing so are imminent. *Phacelia submutica* (DeBeque phacelia)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. DeBeque phacelia is an annual flowering plant endemic to clay soils derived from the Atwell Gulch and Shire members of the Wasatch Formation in Mesa and Garfield Counties, Colorado. There are approximately 40 populations, all less than five acres. The number of plants varies from none to thousands each year, depending on precipitation. The habitat coincides with high quality oil and gas reserves of the Piceance Basin, mostly on federal lands. The primary threats are gas field development and associated construction and transportation activities, as well as increased access for all-terrain vehicles. Substantial surface disturbance alters the unique soil structure and destroys seed banks that are critical to the survival of this species. These threats are ongoing, therefore imminent. They are of moderate magnitude because the threat from oil and gas construction and transportation activities only affects a little over half of the land area where this plant occurs. We retained an LPN of 8 for this species. *Phyllostegia bracteata* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Phyllostegia bracteata* is a scandent perennial herb found in *Metrosideros-Cheirodendron-Dicranopteris* (ohia-olapa-uluhe) montane wet forest. Currently this species is known from five populations totaling no more than 19 individuals on east and west Maui. *Phyllostegia bracteata* is threatened by feral pigs that may directly prey upon it and degrade and destroy habitat, nonnative plants that compete for light and nutrients, and reduced reproductive vigor and randomly occurring natural events. The threats to *P. bracteata* from pigs and nonnative plants are of a high magnitude and imminent because in light of their severity, they pose a risk to the species range-wide, are ongoing, and are not subject to any control efforts. Therefore, we retained an LPN of 2 for this species. *Phyllostegia floribunda* (no common name)—See above in *“Summary of Listing Priority Changes in Candidates.”* No new information was provided in the petition we received on May 11, 2004. *Phyllostegia hispida* (no common name)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Physaria tuplashensis* (White Bluffs bladder-pod)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. White Bluffs bladder-pod is a low-growing, herbaceous, short-lived, perennial plant in the Brassicaceae (mustard) family. Historically and currently, White Bluffs bladder-pod has only been known from a single population that occurs along the White Bluffs of the Columbia River in Franklin County, Washington. The entire range of the species is a narrow band, approximately 33 feet (10 meters) wide by 10.6 miles (17 kilometers) long, at the upper edge of the bluffs. The species occurs only on cemented, highly alkaline, calcium carbonate paleosol (a “caliche” soil) and is believed to be a “calciphile.” Approximately 35 percent of the known range of the species has been moderately to severely affected by landslides, an apparently permanent destruction of the habitat. The entire population of the species is down-slope of irrigated agricultural land, the source of the water seepage causing the mass failures and landslides. Other significant threats include the presence of invasive plants, and some potential use of the habitat by recreational off road vehicles. While *P. tuplashensis* is inherently vulnerable because it is a narrow endemic, the threats are nonimmient since they are unlikely to occur in the immediate future, except the threat from invasive plants. Invasive plants are present in the vicinity, but have not yet been described as a significant problem. Currently, we know of no plans to expand or significantly modify the existing agriculture activities in areas adjacent to the population. In addition, deliberate modification of the species' immediate habitat is unlikely due to its location and 85 percent Federal ownership. However, because the threats could negatively affect the only known population of this species, the threats are high in magnitude. Therefore we assigned an LPN of 5 to this species. *Pittosporum napaliense* (Hoawa)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Platanthera integrilabia* (Correll) Leur (White fringeless orchid)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Platanthera integrilabia* is a perennial herb that grows in partially, but not fully, shaded, wet, boggy areas at the head of streams and on seepage slopes in Alabama, Georgia, Kentucky and Tennessee. Historically, there were at least 90 populations of *Platanthera integrilabia.* Currently there are only 53 extant sites supporting the species. Several populations have been lost to road, residential and commercial construction, and to projects that altered soil and site hydrology and thereby reduced site suitability for the species. Several of the known populations are in or adjacent to powerline rights-of-way. Mechanical clearing of these areas may benefit the species by maintaining adequate light levels; however, the use of herbicides could pose a significant threat to the species. All-terrain vehicles have damaged several sites and pose a threat to most sites. Most of the known sites for the species occur in areas that are managed specifically for timber production. Timber management is not necessarily incompatible with the protection and management of the species. However, care must be taken during timber management to ensure that the hydrology of the bogs that supports the species is not altered. Natural succession can result in decreased light levels. Because of the dependence of the species upon moderate to high light levels, some type of active management to prevent complete canopy closure is required at most locations. Collecting for commercial and other purposes is a threat. Herbivory (primarily deer) threatens the species at several sites. Protection and recovery of this species is dependent upon active management rather than just preservation of its habitat. Invasive, nonnative plants such as Japanese honeysuckle and kudzu threaten several sites. Given the number and severity of current threats to this species, the magnitude of threat is high. Based upon the number of populations and the anticipation that most of these threats will not be realized in the next 1-2 years, the threats are nonimminent. We, therefore, assigned an LPN of 5 to this species. *Platydesma cornuta* var. *cornuta* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This variety is an erect palmoid shrub found in mesic forest on Oahu, Hawaii. This variety is known from 9 populations with a combined total of approximately 36 individuals in the Koolau Mountains on the island of Oahu. Limited monitoring has shown that this population is declining. The threats to *P. cornuta* var. *cornuta* include feral pigs that degrade and destroy habitat and possibly prey upon it, and nonnative plants that compete for light and nutrients. All of the threats occur range-wide and no efforts for their control or eradication are being undertaken. We retained an LPN of 3 for this variety. The threats are of a high magnitude because they are sufficiently severe to result in direct mortality or significantly reduce the reproductive capacity of this plant variety. In addition, they are ongoing, so are imminent. *Platydesma cornuta* var. *decurrens* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. This variety is an erect palmoid shrub found in mesic forest on Oahu, Hawaii. This variety is known from several populations totaling a few hundred individuals in the Waianae Mountains. *Platydesma cornuta* var. *decurrens* is threatened by feral pigs and goats that degrade and destroy habitat and possibly prey upon the plants, and by nonnative plants that compete for light and nutrients. All of the threats occur range-wide, and no efforts for their control or eradication are being undertaken, other than the current protection of 5 individuals within a fenced enclosure maintained by The Nature Conservancy of Hawaii. We retained an LPN of 3 for this variety. The threats are high in magnitude because the threats are sufficiently severe to result in direct mortality or significantly reduce the reproductive capacity of this plant variety particularly given its small population size. In addition, the threats are ongoing, so are imminent. *Platydesma remyi* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Platydesma remyi* is a shrub or shrubby tree found in wet forests on old volcanic slopes on the island of Hawaii, Hawaii. This species is known from two populations totaling fewer than 50 individuals. *Platydesma remyi* is threatened by feral pigs and cattle that degrade and destroy habitat, nonnative plants that compete for light and nutrients, reduced reproductive vigor, and stochastic extinction due to naturally occurring events. Only one individual is included in a rare plant exclosure in the Laupahoehoe Natural Area Reserve. These threats are ongoing and therefore imminent, and of a high magnitude because of their severity; the threats cause direct mortality or significantly reduce the reproductive capacity of the species throughout its limited range. Therefore, we retained an LPN of 2 for this species. *Platydesma rostrata* (Pilo kea lau lii)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Pleomele forbesii* (Hala pepe)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Pleomele forbesii* is a tree found in diverse mesic and dry forests on Oahu, Hawaii. This species is currently known from 16 populations totaling 500 individuals. *Pleomele forbesii* is threatened by predation by rats, habitat degradation and destruction by feral pigs and goats, fire, and nonnative plants that compete for light and nutrients. One population is protected within a fenced area by the U.S. Navy and the species is represented in an ex situ collection; however, no other conservation efforts are being implemented to alleviate the threats to *P. forbesii* . The threats are of a high magnitude because of their severity and their potential to adversely affect this plant throughout its range in all 16 populations. The threats are ongoing and therefore, imminent. Thus, we retained an LPN of 2 for this species. *Potentilla basaltica* (Soldier Meadow cinquefoil or basalt cinquefoil)—The following summary is based on information contained in our files; the petition we received on May 11, 2004, provided no additional information on the species. Soldier Meadow cinquefoil is a low-growing, rhizomatous, herbaceous perennial that is associated with alkali meadows, seeps, and occasionally marsh habitats bordering perennial thermal springs, outflows, and meadow depressions. In Humboldt County, Nevada, the species is known only from Soldier Meadow. In northeastern California, a single population occurs in Lassen County. At Soldier Meadow, there are 10 discrete known occurrences within an area of about 70 acres that support about 130,000 individuals. The California population occupies less than an acre on private lands and supports fewer than 1,000 plants. The species and its habitat are threatened by recreational use in the areas where it occurs, as well as the ongoing impacts of past water diversions and livestock grazing and current off-highway vehicle travel. Conservation measures implemented recently by the Bureau of Land Management include the installation of fencing to exclude livestock, wild horses, burros and other large mammals; closing of access roads to spring, riparian, and wetland areas and the limiting of vehicles to designated routes; the establishment of a designated campground away from the habitats of sensitive species; the installation of educational signage; and, an increased staff presence, including law enforcement and a volunteer site steward during the six-month period of peak visitor use. These conservation measures have reduced the magnitude of threat to the species to moderate; all remaining threats are nonimminent and involve long-term changes to the habitat for the species resulting from past impacts. Until a monitoring program is in place that allows us to assess the long-term trend of the species, we continue to assign this species an LPN of 11. *Pritchardia hardyi* (Loulu)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Pseudognaphalium* ( *Gnaphalium* ) *sandwicensium* var. *molokaiense* (Enaena)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Pseudognaphalium sandwicensium* var. *molokaiense* is a perennial herb found in strand vegetation in dry consolidated dunes on Molokai and Maui, Hawaii. This variety is known from a total of four populations with several hundred individuals in the Moomomi area on the island of Molokai, and a single population of 25 individuals at Puu Kahulianapa on west Maui. *Pseudognaphalium sandwicensium* var. *molokaiense* is threatened by axis deer and cattle that degrade and destroy habitat and possibly prey upon it, and by nonnative plants that compete for light and nutrients. Potential threats also include collection for lei and off-road vehicles that directly damage plants and degrade habitat. While ungulate exclusion fences protect the three populations of *P. sandwicensium* var. *molokaiense* on Molokai and nonnative plant control has been implemented in these populations, no conservation efforts have been initiated to date for the individuals on Maui. The ongoing threats from axis deer, cattle, nonnative plants, collection, and off-road vehicles are of a high magnitude because no control measures have been undertaken for the Maui population and the threats therefore pose a significant threat to this plant. Therefore, we retained an LPN of 3 for this variety. *Psychotria grandiflora* (Kopiko)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Psychotria hexandra* ssp. *oahuensis* var. *oahuensis* (Kopiko)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Psychotria hexandra* ssp. *oahuensis* var. *oahuensis* is a tree or shrub found in mesic and wet forests on Oahu, Hawaii. This variety is known from three populations of fewer than 20 individuals. Two other varieties of this subspecies, var. *hosakana* and var. *rockii* , are extinct. *Psychotria hexandra* ssp. *oahuensis* var. *oahuensis* is threatened by feral pigs and rats that consume this plant and degrade and destroy habitat, rats that consume its fruit, and nonnative plants that compete for light and nutrients. All of the threats occur range-wide, and no efforts for their control or eradication are being undertaken. We retained an LPN of 3 because the threats are of a high magnitude because they could adversely affect this plant variety resulting in direct mortality or reduced reproductive capacity, and are ongoing, so are imminent. *Psychotria hobdyi* (Kopiko)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Pteralyxia macrocarpa* (Kaulu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Kaulu is a tree found in valleys and slopes in diverse mesic forest on Oahu, Hawaii. This species is known from 20 populations totaling less than 300 individuals. This species is threatened by feral pigs and goats that degrade and destroy habitat; nonnative plants that compete for light and nutrients; and possibly by predation from feral pigs, goats, rats, and the two-spotted leafhopper. These threats are of a high magnitude because in light of their severity and the absence of control or eradication efforts, they have the potential to adversely affect this plant species throughout its limited range. The threats are also imminent because they are ongoing. We retained an LPN of 2 for this species. *Ranunculus hawaiensis* (Makou)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Ranunculus hawaiensis* is an erect or ascending perennial herb found in mesic to wet forest dominated by *Metrosideros polymorpha* and *Acacia koa* with scree substrate on Maui and the island of Hawaii, Hawaii. Populations formerly within Haleakala National Park have been extirpated. This species is known from fewer than 300 individuals in six populations. Four wild populations occur on Hawaii, and three outplanted populations and two wild populations occur on Maui, one on east Maui at Kahikinui and one on west Maui at Lihau. *Ranunculus hawaiensis* is threatened by direct predation by slugs, feral pigs, goats, cattle, mouflon, and sheep; by pigs, goats, cattle, mouflon and sheep that degrade and destroy habitat; and by nonnative plants that compete for light and nutrients. Three populations have been outplanted into protected exclosures; however, feral ungulates and nonnative plants are not controlled in the remaining, unfenced populations. In addition, the threat from slugs is of a high magnitude because slugs occur throughout the limited range of this species and no effective measures have been undertaken to control them or prevent them from causing significant adverse impacts to this species. Therefore, the threats from pigs, goats, cattle, mouflon, sheep, slugs, and nonnative plants are of a high magnitude and ongoing and imminent for *R. hawaiensis* . We retained an LPN of 2 for this species. *Ranunculus mauiensis* (Makou)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Ranunculus mauiensis* is an erect to weakly ascending perennial herb found in open sites in mesic to wet forest and along streams on the islands of Maui, Kauai, and Molokai, Hawaii. This species is currently known from fewer than 200 individuals on Molokai, more than 100 individuals on Maui, and approximately 76 individuals on Kauai. *Ranunculus mauiensis* is threatened by feral pigs, goats, deer and slugs that consume it; by habitat degradation and destruction by feral pigs, goats and deer; and by nonnative plants that compete for light and nutrients. Feral pigs have been fenced out of the Maui populations of *R. mauiensis* , and nonnative plants have been reduced in the fenced areas. One individual occurs in the Kamakou Preserve on Molokai, managed by The Nature Conservancy of Hawaii. However, these ongoing conservation efforts benefit only the Maui and Molokai individuals and absent conservation efforts for the Kauia individuals, these threats present a significant risk to the continued existence of *R. mauiensis* . Therefore, the threats continue to be of a high magnitude to this species on Kauai. Threats to the species overall are also of a high magnitude, since half of the individuals are found on Kauai. In addition, threats to *R. mauiensis* are imminent because they are ongoing in the Kauai and the majority of the Maui populations. Therefore, we retained an LPN of 2 for this species. *Rorippa subumbellata* (Tahoe yellow cress)—The following summary is based on information contained in our files and the petition we received on December 27, 2000. Tahoe yellow cress is a small perennial herb known only from the shores of Lake Tahoe in California and Nevada. Data collected over the last 25 years generally indicate that species occurrence fluctuates yearly as a function of both lake level and the amount of exposed habitat. Records kept since 1900 show a preponderance of years with high lake levels that would isolate and reduce Tahoe yellow cress occurrences at higher beach elevations. From the standpoint of the species, less favorable peak years have occurred almost twice as often as more favorable low-level years. Annual surveys are conducted to determine population numbers, site occupancy, and general disturbance regime. During the 2003 and 2004 annual survey period, the lake level was approximately 6,224 ft (1,898 m); 2004 was the fourth consecutive year of low water. Tahoe yellow cress was present at 45 of the 72 sites surveyed (65 percent occupied), up from 15 sites (19 percent occupied) in 2000 when the lake level was high at 6,228 ft. Approximately 25,200 stems were counted or estimated in 2003, whereas during the 2000 annual survey, the estimated number of stems was 4,590. Lake levels began to rise again in 2005 and less habitat was available; intermediate lake levels are expected in 2007. Many Tahoe yellow cress sites are intensively used for commercial and public purposes and are subject to various activities such as erosion control, marina developments, pier construction, and recreation. The U.S. Forest Service, California Tahoe Conservancy, and California Department of Parks and Recreation have management programs for Tahoe yellow cress that include monitoring, fenced enclosures, and transplanting efforts when funds and staff are available. Public agencies (including the Service), private landowners, and environmental groups collaborated to develop a conservation strategy coupled with a Memorandum of Understanding/Conservation Agreement. The conservation strategy, completed in 2003, contains goals and objectives for recovery and survival, a research and monitoring agenda, and serves as the foundation for an adaptive management program. Because of the continued commitments to conservation demonstrated by regulatory and land management agencies participating in the conservation strategy, we have determined the threats to Tahoe yellow cress from various land uses have been reduced to a moderate magnitude. In high lake level years such as 2005, however, recreational use is concentrated within Tahoe yellow cress habitat, and we consider this threat in particular to be ongoing and imminent. Therefore, we maintained an LPN of 8 for this species. *Schiedea attenuata* (no common name)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Schiedea pubescens* (Maolioli)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Schiedea pubescens* is a reclining or weakly climbing vine found in diverse mesic to wet forest on Maui and Molokai, Hawaii. Currently, this species is known from six populations totaling approximately 100 individuals on Maui and Molokai. *Schiedea pubescens* is threatened by feral goats that consume it and degrade and destroy habitat, and by nonnative plants that compete for light and nutrients. Feral ungulates have been fenced out of the population of *S. pubescens* on Hawaii, and feral goats have been fenced out of a few of the west Maui populations of *S. pubescens.* Nonnative plants have been reduced in the populations that are fenced on Maui. However, the threats are not controlled and are ongoing in the remaining unfenced populations on Maui and the three populations on Molokai. In light of the extremely low number of individuals of this species, the threats from goats and nonnative plants are of a high magnitude because they pose a significant threat to the species, and imminent because they are ongoing. Therefore, we retained an LPN of 2 for this species. *Schiedea salicaria* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Schiedea salicaria* is an erect subshrub or shrub found on ridges and steep slopes in dry shrubland on Maui, Hawaii. Currently, this species is declining throughout its range, and is known from six populations totaling 100 to 300 individuals, typically of 25 individuals per population. This species is threatened by cattle that may directly prey upon it and degrade and destroy habitat, fire, and nonnative plants that compete for light and nutrients. This species is represented in an *ex-situ* collection. All of the threats occur range-wide, and no efforts for their control or eradication are being undertaken. We retained an LPN of 2. The threats are imminent because they are ongoing, and are of a high magnitude, because in light of their severity and the small size of the population, they have the potential to adversely affect the species. *Sedum eastwoodiae* (Red Mountain stonecrop)—The following summary is based on information contained in our files and information provided by the California Department of Fish and Game. The petition we received on May 11, 2004 provided no new information on the species. Red Mountain stonecrop is a perennial succulent which occupies relatively barren, rocky openings and cliffs in lower montane coniferous forests, between 1,900 and 4,000 feet elevation. Its distribution is limited to Red Mountain, Mendocino County, California, where it occupies 30 acres scattered over 4 square miles. Total population size is estimated at between 5,300 and 23,000 plants, contained within 27 habitat polygons. Intensive monitoring suggests considerable annual variation in plant seedling success and inflorescence production; stonecrop density varied from year-to-year. The primary threat to the species is the potential for surface mining for chromium and nickel. The entire distribution area of Red Mountain stonecrop is either owned by mining interests or covered by mining claims that are not currently active. Surface mining would destroy habitat suitability for this species. The species is also believed threatened by tree and shrub encroachment into its habitat, in absence of fire. The species distribution by ownership is described as follows: Federal (Bureau of Land Management)—95 percent ( this portion of the distribution was recently included in the South Fork Eel River Wilderness Area, managed by BLM); and private—5 percent. Given the magnitude (high, because mining of the area would put the continued existence of the species at risk) and immediacy (nonimminent, because there are no known plans to mine the area) of the threat to the small, scattered populations, and its taxonomy (species), we assigned an LPN of 5 to this species. *Sicyos macrophyllus* (Anunu)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Sicyos macrophyllus* is a perennial vine found in wet *Metrosideros polymorpha*

(ohia)forest and subalpine *Sophora chrysophylla-Myoporum sandwicense* (mamane-naio) forest on the island of Hawaii, Hawaii. This species is known from six populations totaling a few hundred individuals in the Kohala and Mauna Kea areas and in Hawaii Volcanoes National Park (Puna area) on the island of Hawaii. It appears that a naturally occurring population at Kipuka Ki in Hawaii Volcanoes National Park is reproducing by seeds, but seeds have not been successfully germinated under nursery conditions. This species is threatened by feral pigs and sheep that degrade and destroy habitat, and nonnative plants that compete for light and nutrients. Feral pigs have been fenced out of some of the areas where *S. macrophyllus* currently occurs, but the fences do not exclude sheep. Nonnative plants have been reduced in the populations that are fenced. However, the threats are not controlled and are ongoing in the remaining, unfenced populations, and are, therefore, imminent. Similarly the threat from sheep is ongoing and imminent in all populations, because the current fences do not exclude sheep. In addition, all of the threats are of a high magnitude, because habitat degradation and competition from nonnative plants present a risk to the species, resulting in direct mortality or significantly reducing the reproductive capacity. Therefore, we retained an LPN of 2 for this species. *Solanum nelsonii* (popolo)—See above in “ *Summary of Listing Priority Changes in Candidates.* ” The above summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *Stenogyne cranwelliae* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Stenogyne cranwelliae* is a creeping vine found in wet forest dominated by *Metrosideros polymorpha* on the island of Hawaii, Hawaii. *Stenogyne cranwelliae* is known from 10 populations totaling 100 individuals. This species is threatened by feral pigs that degrade and destroy habitat, and nonnative plants that compete for light and nutrients. In addition, this species is potentially threatened by rats that may directly prey upon it, and by randomly occurring natural events such as hurricanes and landslides. All of the threats occur range-wide and no efforts for their control or eradication are being undertaken. These threats are sufficient to adversely affect the species particularly in light of its small population size. We retained an LPN of 2 because the threats are of a high magnitude and are ongoing, so are imminent. *Stenogyne kealiae* (no common name)—We have not updated our candidate assessment for this species, as we are currently developing a proposed listing rule. *Symphyotrichum georgianum* (Georgia aster)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information from our files. No new information was provided in the petition we received on May 11, 2004. *Zanthoxylum oahuense* (Ae)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Zanthoxylum oahuense* is a small tree found in mesic to wet forest habitat on Oahu, Hawaii. Currently this species is known from 11 populations totaling fewer than 40 individuals on Oahu. *Zanthoxylum oahuense* is threatened by feral pigs that directly prey upon it and degrade and destroy habitat, nonnative plants that compete for light and nutrients, and the two-spotted leafhopper. All of the threats occur range-wide and no efforts for their control or eradication are being undertaken. These threats are sufficient to adversely affect the species particularly in light of its small population size. We retained an LPN of 2 for this species, because the threats are of a high magnitude and are ongoing, so are imminent. Ferns and Allies *Christella boydiae* (no common name)—See above in “ *Summary of Listing Priority Changes in Candidates* .” The above summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. *Doryopteris takeuchii* (no common name)—We have not updated our candidate assessment, as we are currently developing a proposed listing rule for this species. *Huperzia stemmermanniae* (no common name)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Waewaeiole, a pendant clubmoss, is found in mesic to wet *Metrosideros polymorpha-Acacia koa* (ohia-koa) forests on the islands of Maui and Hawaii, Hawaii. Only four populations are known, totaling fewer than 30 individuals on Hawaii and Maui. *Huperzia stemmermanniae* is threatened by feral pigs, goats, cattle, and deer that degrade and/or destroy habitat, and by nonnative plants that compete for light, space, and nutrients. *Huperzia stemmermanniae* is also threatened by randomly occurring natural events due to its small population size. One population at Waikamoi Preserve may benefit from fencing for deer and pigs. The threats to *H. stemmermanniae* from pigs, goats, cattle, deer, and nonnative plants are of a high magnitude because they are sufficiently severe to adversely affect the species throughout its range, resulting in direct mortality or significantly reducing reproductive capacity. They are imminent because they are ongoing. Therefore, we retained an LPN of 2 for this species. *Microlepia strigosa* var. *mauiensis* (Palapalai)—The following summary is based on information contained in our files. No new information was provided in the petition we received on May 11, 2004. Palapalai is a fern found in mesic to wet forests. It is currently found on the islands of Maui, Hawaii, and Oahu, from at least 11 populations totaling more than 35 individuals. There is a possibility that the range of this plant variety could be larger and include the other main Hawaiian Islands. *Microlepia strigosa* var. *mauiensis* is threatened by feral pigs that degrade and destroy habitat, and nonnative plants that compete for light and nutrients. Pigs have been fenced out of areas on east and west Maui, and on Hawaii, where *M. strigosa* var. *mauiensis* currently occurs, and nonnative plants have been reduced in the fenced areas. However, the threats are not controlled and are ongoing in the remaining unfenced populations on Maui, Hawaii, and Oahu. Therefore, the threats from feral pigs and nonnative plants are imminent. They are also of a high magnitude because they are sufficiently severe to adversely affect the species throughout its range, resulting in direct mortality or significantly reducing reproductive capacity. We therefore retained an LPN of 3 for *M. strigosa* var. *mauiensis* . Petitions To Reclassify Species Already Listed We previously made warranted-but-precluded findings on five petitions seeking to reclassify threatened species to endangered status. Because these species are already listed, they are not technically candidates for listing and are not included in Table 1. However, this notice and associated species assessment forms also constitute the resubmitted petition findings for these species. For the three grizzly bear populations, we have not updated our resubmitted petition findings through this notice as explained below. For the other two species (spikedace and loach minnow), we find that reclassification to endangered status is currently warranted but precluded by work identified above (see “ *Petition Findings for Candidate Species* ” above). One of the primary reasons that the work identified above is higher priority is that these species are currently listed as threatened under the Act, and therefore they already receive certain protections under the Act. The Service promulgated regulations extending take prohibitions for endangered species under section 9 to threatened species (50 CFR 17.31). Prohibited actions under section 9 include, but are not limited to, take (i.e., harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in such activity). Other protections include those under section 7(a)(2) of the Act whereby Federal agencies must insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of any endangered or threatened species.

(1)Grizzly bear ( *Ursus arctos horribilis* ) North Cascades ecosystem, Cabinet-Yaak, and Selkirk populations (Region 6)—We have not updated our finding with regard to the grizzly bear populations in the North Cascade, the Cabinet-Yaak, or the Selkirk Ecosystems in this notice. Between 1991 and 1999, we issued warranted but precluded findings to reclassify grizzly bears as endangered in the North Cascades (56 FR 33892-33894, July 24, 1991; 63 FR 30453-30454, June 4, 1998), the Cabinet-Yaak (58 FR 8250-8251, February 12, 1993; 64 FR 26725-26733, May 17, 1999), and the Selkirk Ecosystems (64 FR 26725-26733, May 17, 1999). We also made previous resubmitted petition findings that uplisting these three populations to endangered was warranted but precluded through previous CNORS (most recently on September 12, 2006; 71 FR 53755). However, none of the findings included a formal analysis under our 1996 Policy Regarding the Recognition of Distinct Vertebrate Population Segments

(DPS)under the Endangered Species Act (61 FR 4722-4725, February 7, 1996). Under this policy a formal analysis of discreteness and significance is necessary to determine if the entity is a “listable entity.” While our 1999 revised 12-month finding performed a preliminary DPS analysis, it appears to have incorrectly analyzed significance to the listed entity (i.e., grizzly bears in the lower 48 States) instead of significance to the taxon ( *Ursus arctos horribilis* ) as required by our DPS policy (64 FR 26725-26733, May 17, 1999; 61 FR 4722-4725, February 7, 1996; *National Association of Home Builders* v. *Norton* , 340 F. 3d 835, 852 (9th Cir. 2003)). Additionally, emerging biological information now suggests increasing levels of connectivity among some of these populations, casting doubt on their discreteness. Also relevant is the March 16, 2007, Department of Interior Office of the Solicitor memorandum (available at: *http://www.doi.gov/solicitor/M37013.pdf* ) regarding the meaning of “significant portion of [a species'] range.” This memorandum states that “whenever the Secretary concludes because of the statutory five-factor analysis that a species is ‘in danger of extinction throughout * * * a significant portion of its range,' it is to be listed and the protections of the ESA applied to the species in that portion of its range.” The memorandum goes on to say, “the Secretary has broad discretion in defining what portion of a range is ‘significant.' ” To date, the Service has not determined whether the North Cascade, the Cabinet-Yaak, or the Selkirk Ecosystems each constitutes a significant portion of the grizzly bear's range or whether they only represent significant portions of the species' range when combined with other units. On April 18, 2007, the Service initiated a 5-year review to evaluate the current status of grizzly bears in the lower 48-States outside of the Greater Yellowstone Area (72 FR 19549-19551). This status review will fully evaluate the status of each population and the appropriate application of the DPS policy and the solicitor memorandum regarding recognition and listing of significant portions of range. We expect this 5-year review to be completed in 2008.

(2)Spikedace ( *Meda fulgida* ) (Region 2) (see 59 FR 35303, July 11, 1994, and the species assessment form (see ADDRESSES ) for additional information on why reclassification to endangered is warranted-but-precluded)—The spikedace, a small fish species in a monotypic genus, is found in moderate-to-large perennial waters, where it inhabits shallow riffles with sand, gravel, and rubble substrates, and moderate-to-swift currents and swift pools over sand or gravel substrates. This species is now common only in Aravaipa Creek and portions of the upper Gila River in New Mexico. Smaller, less stable populations occur in some areas of the upper Gila, as well as in the Verde River. The threats to this species are primarily from nonnative aquatic species and water withdrawals, including groundwater pumping. Other threats include grazing, road construction, and recreation. Spikedace occur in only 5 to 10 percent of their historical range, and threats occur over the majority of their range, to varying degrees. Threats are exacerbated by ongoing drought. In addition, different threats can interact with each other to further cause decline. For example, drought and water withdrawals may decrease the amount of habitat available to all species within a given stream, forcing natives and nonnatives into closer proximity to one another. Effects from nonnative species introductions are permanent, unless streams are actively renovated and/or barriers installed to preclude further recolonization by nonnatives. Grazing pressures have eased somewhat as Federal agencies remove cattle from streams directly, but upland conditions continue to degrade watersheds in general. Groundwater withdrawals or exchanges that affect streamflow are not reversible. For these reasons, the magnitude of the threat to this species is high. In addition, most of the threats to this species are already ongoing, in particular grazing, water withdrawals, nonnative stocking programs, recreational use, and drought. Because threats have gone on for many years in the past, are associated with irreversible commitments (i.e., water exchanges), or are not easily reversed (i.e., nonnative stocking and impacts from grazing), the threats to the species are imminent. Therefore, we assigned this species an LPN of 1 for uplisting to endangered.

(3)Loach minnow ( *Tiaroga cobitis* ) (Region 2) (see 59 FR 35303, July 11, 1994, and the species assessment form (see ADDRESSES ) for additional information on why reclassification to endangered is warranted-but-precluded)—This small fish, the only species within the genus, is found in small-to-large perennial streams and uses shallow, turbulent riffles with primarily cobble substrate and swift currents. This species is now common only in Aravaipa Creek and the Blue River in Arizona, and limited portions of the San Francisco, upper Gila, and Tularosa rivers in New Mexico. Smaller, less stable populations occur in some areas of the upper Gila, such as the Middle Fork and in small areas of several tributary streams to Aravaipa Creek and the Blue and Tularosa rivers, such as Pace, Frieborn, Negrito, Turkey, and Deer creeks. Small populations are also present in Eagle Creek and the Black River. The threats to this species are primarily from nonnative aquatic species and water withdrawals, including groundwater pumping. Other threats include grazing, road construction, and recreation. Loach minnow occur in only 10 to 15 percent of their historic range, and threats occur over the majority of their range, to varying degrees. Threats are exacerbated by ongoing drought. In addition, different threats can interact with each other to further cause decline. For example, drought and water withdrawals may decrease the amount of habitat available to all species within a given stream, bringing natives and nonnatives into closer contact. Effects from nonnative species introductions are permanent, unless streams are actively renovated and/or barriers installed to preclude further recolonization by nonnatives. Grazing pressures have eased somewhat as Federal agencies remove cattle from streams directly, but upland conditions continue to degrade watersheds in general. Groundwater withdrawals or exchanges that affect streamflow are not reversible. For these reasons, the magnitude of the threats to this species is high. In addition, most of the threats to this species are already ongoing, in particular grazing, water withdrawals, nonnative stocking programs, recreational use, and drought. Because threats have gone on for many years in the past, are associated with irreversible commitments (i.e., water exchanges), or are not easily reversed (i.e., nonnative stocking and impacts from grazing), the threats to this species are imminent. Therefore, we assigned this species an LPN of 1 for uplisting to endangered. Current Notice of Review We gather data on plants and animals native to the U.S. that appear to merit consideration for addition to the Lists of Endangered and Threatened Wildlife and Plants. This notice identifies those species that we currently regard as candidates for addition to the Lists. These candidates include species and subspecies of fish, wildlife, or plants and DPSs of vertebrate animals. This compilation relies on information from status surveys conducted for candidate assessment and on information from State Natural Heritage Programs, other State and Federal agencies, knowledgeable scientists, public and private natural resource interests, and comments received in response to previous notices of review. Tables 1 and 2 list animals arranged alphabetically by common names under the major group headings and list plants alphabetically by names of genera, species, and relevant subspecies and varieties. Animals are grouped by class or order. Plants are subdivided into two groups:

(1)Flowering plants and

(2)ferns and their allies. Useful synonyms and subgeneric scientific names appear in parentheses with the synonyms preceded by an “equals” sign. Several species that have not yet been formally described in the scientific literature are included; such species are identified by a generic or specific name (in italics), followed by “sp.” or “ssp.” We incorporate standardized common names in these notices as they become available. We sorted plants by scientific name due to the inconsistencies in common names, the inclusion of vernacular and composite subspecific names, and the fact that many plants still lack a standardized common name. Table 1 lists all candidate species and all species proposed for listing under the Act. We emphasize that we are not proposing these candidate species for listing by this notice, but we anticipate developing and publishing proposed listing rules for these species in the future. We encourage State agencies, other Federal agencies, and other parties to give consideration to these species in environmental planning. In Table 1, the “category” column on the left side of the table identifies the status of each species according to the following codes: PE—Species proposed for listing as endangered. Proposed species are those species for which we have published a proposed rule to list as endangered or threatened in the **Federal Register** . This category does not include species for which we have withdrawn or finalized the proposed rule. PT—Species proposed for listing as threatened. PSAT—Species proposed for listing as threatened due to similarity of appearance. C—Candidates: Species for which we have on file sufficient information on biological vulnerability and threats to support proposals to list them as endangered or threatened. Issuance of proposed rules for these species is precluded at present by other higher-priority listing actions. This category includes species for which we made a 12-month warranted-but-precluded finding on a petition to list. We made new findings on all petitions for which we previously made “warranted-but-precluded” findings. We identify the species for which we made a continued warranted-but-precluded finding on a resubmitted petition by the code “C*” in the category column (see “Findings on Resubmitted Petitions” section for additional information). The “Priority” column indicates the LPN for each candidate species which we use to determine the most appropriate use of our available resources. The lowest numbers have the highest priority. We assign LPNs based on the immediacy and magnitude of threats as well as on taxonomic status. We published a complete description of our listing priority system in the **Federal Register** (48 FR 43098, September 21, 1983). The third column, “Lead Region,” identifies the Regional Office to which you should direct comments or questions (see addresses at the end of the SUPPLEMENTARY INFORMATION section). Following the scientific name (fourth column) and the family designation (fifth column) is the common name (sixth column). The seventh column provides the known historic range for the species or vertebrate population (for vertebrate populations, this is the historic range for the entire species or subspecies and not just the historic range for the distinct population segment), indicated by postal code abbreviations for States and U.S. territories. Many species no longer occur in all of the areas listed. Species in Table 2 of this notice are species we included either as proposed species or as candidates in the previous CNOR (published May 11, 2005) that are no longer proposed species or candidates for listing. Since May 11, 2005, we removed two species from proposed status and removed six species from candidate status for the reasons indicated by the codes. The first column indicates the present status of the species, using the following codes (not all of these codes may have been used in this CNOR): E—Species we listed as endangered. T—Species we listed as threatened. Rc—Species we removed from the candidate list because currently available information does not support a proposed listing. Rp—Species we removed from the candidate list because we have withdrawn the proposed listing. The second column indicates why we no longer regard the species as a candidate or proposed species using the following codes (not all of these codes may have been used in this CNOR): A—Species that are more abundant or widespread than previously believed and species that are not subject to the degree of threats sufficient to warrant continuing candidate status, or issuing a proposed or final listing. F—Species whose range no longer includes a U.S. territory. I—Species for which we have insufficient information on biological vulnerability and threats to support issuance of a proposed rule to list. L—Species we added to the Lists of Endangered and Threatened Wildlife and Plants. M—Species we mistakenly included as candidates or proposed species in the last notice of review. N—Species that are not listable entities based on the Act's definition of “species” and current taxonomic understanding. U—Species not subject to the degree of threats sufficient to warrant issuance of a proposed listing or continuance of candidate status due, in part or totally, to conservation efforts that remove or reduce the threats to the species. X—Species we believe to be extinct. The columns describing lead region, scientific name, family, common name, and historical range include information as previously described for Table 1. Request for Information We request you submit any further information on the species named in this notice as soon as possible or whenever it becomes available. We are particularly interested in any information:

(1)Indicating that we should add a species to the list of candidate species;

(2)Indicating that we should remove a species from candidate status;

(3)Recommending areas that we should designate as critical habitat for a species, or indicating that designation of critical habitat would not be prudent for a species;

(4)Documenting threats to any of the included species;

(5)Describing the immediacy or magnitude of threats facing candidate species;

(6)Pointing out taxonomic or nomenclature changes for any of the species;

(7)Suggesting appropriate common names; and

(8)Noting any mistakes, such as errors in the indicated historical ranges. Submit your comments regarding a particular species to the Regional Director of the Region identified as having the lead responsibility for that species. The regional addresses follow: Region 1. Hawaii, Idaho, Oregon, Washington, American Samoa, Guam, and Commonwealth of the Northern Mariana Islands. Regional Director (TE), U.S. Fish and Wildlife Service, Eastside Federal Complex, 911 N.E. 11th Avenue, Portland, OR 97232-4181 (503/231-6158). Region 2. Arizona, New Mexico, Oklahoma, and Texas. Regional Director (TE), U.S. Fish and Wildlife Service, 500 Gold Avenue SW., Room 4012, Albuquerque, NM 87102 (505/248-6920). Region 3. Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. Regional Director (TE), U.S. Fish and Wildlife Service, Bishop Henry Whipple Federal Building, One Federal Drive, Fort Snelling, MN 55111-4056 (612/713-5334). Region 4. Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Puerto Rico, and the U.S. Virgin Islands. Regional Director (TE), U.S. Fish and Wildlife Service, 1875 Century Boulevard, Suite 200, Atlanta, GA 30345 (404/679-4156). Region 5. Connecticut, Delaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and West Virginia. Regional Director (TE), U.S. Fish and Wildlife Service, 300 Westgate Center Drive, Hadley, MA 01035-9589 (413/253-8615). Region 6. Colorado, Kansas, Montana, Nebraska, North Dakota, South Dakota, Utah, and Wyoming. Regional Director (TE), U.S. Fish and Wildlife Service, P.O. Box 25486, Denver Federal Center, Denver, CO 80225-0486 (303/236-7400). Region 7. Alaska. Regional Director (TE), U.S. Fish and Wildlife Service, 1011 East Tudor Road, Anchorage, AK 99503-6199 (907/786-3505). Region 8. California and Nevada. Regional Director (TE), U.S. Fish and Wildlife Service, 2800 Cottage Way, Suite W2606, Sacramento, CA 95825. We will provide comments received in response to the previous CNOR to the Region having lead responsibility for each candidate species mentioned in the comment. We will likewise consider all information provided in response to this CNOR in deciding whether to propose species for listing and when to undertake necessary listing actions (including whether emergency listing pursuant to section 4(b)(7) of the Act is appropriate). Comments we receive will become part of the administrative record for the species, which we maintain at the appropriate Regional Office. Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home addresses from the rulemaking record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold from the record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment, but you should be aware that the Service may be required to disclose your name and address pursuant to the Freedom of Information Act. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. Authority This notice of review is published under the authority of the Endangered Species Act (16 U.S.C. 1531 *et seq.* ). Dated: November 27, 2007. H. Dale Hall, Director, Fish and Wildlife Service. Table 1.—Candidate Notice of Review (Animals and Plants) [Note: See end of Supplementary Information for an explanation of symbols used in this table.] Status Category Priority Lead region Scientific name Family Common name Historic range **Mammals** C* 3 R1 *Emballonura semicaudata rotensis* Emballonuridae Bat, Pacific sheath-tailed (Mariana Islands subspecies) U.S.A. (GU, CNMI). C* 3 R1 *Emballonura semicaudata semicaudata* Emballonuridae Bat, Pacific sheath-tailed (American Samoa DPS) U.S.A. (AS), Fiji, Independent Samoa, Tonga, Vanuatu. PT 2 R7 *Ursus maritimus* Ursidae Bear, polar U.S.A. (AK), Canada, Russia, Denmark Greenland), Norway. C* 2 R5 *Sylvilagus transitionalis* Leporidae Cottontail, New England U.S.A. (CT, MA, ME, NH, NY, RI, VT). C* 6 R8 *Martes pennanti* Mustelidae Fisher (west coast DPS) U.S.A. (CA, CT, IA, ID, IL, IN, KY, MA, MD,ME, MI, MN, MT, ND, NH, NJ, NY, OH, OR, PA, RI, TN, UT, VA, VT, WA, WI, WV, WY), Canada. C 3 R2 *Zapus hudsonius luteus* Zapodidae Mouse, New Mexico meadow jumping U.S.A. (AZ, CO, NM). C* 3 R1 *Thomomys mazama couchi* Geomyidae Pocket gopher, Shelton U.S.A. (WA). C 3 R1 *Thomomys mazama douglasii* Geomyidae Pocket gopher, Brush Prairie U.S.A. (WA). C* 3 R1 *Thomomys mazama glacialis* Geomyidae Pocket gopher, Roy Prairie U.S.A. (WA). C* 3 R1 *Thomomys mazama louiei* Geomyidae Pocket gopher, Cathlamet U.S.A. (WA). C* 3 R1 *Thomomys mazama melanops* Geomyidae Pocket gopher, Olympic U.S.A. (WA). C* 3 R1 *Thomomys mazama pugetensis* Geomyidae Pocket gopher, Olympia U.S.A. (WA). C* 3 R1 *Thomomys mazama tacomensis* Geomyidae Pocket gopher, Tacoma U.S.A. (WA). C* 3 R1 *Thomomys mazama tumuli* Geomyidae Pocket gopher, Tenino U.S.A. (WA). C* 3 R1 *Thomomys mazama yelmensis* Geomyidae Pocket gopher, Yelm U.S.A. (WA). C* 3 R8 *Spermophilus tereticaudus chlorus* Sciuridae Squirrel, Palm Springs (= Coachella Valley) round-tailed ground U.S.A. (CA). C* 9 R1 *Spermophilus brunneus endemicus* Sciuridae Squirrel, Southern Idaho ground U.S.A. (ID). C* 5 R1 *Spermophilus washingtoni* Sciuridae Squirrel, Washington ground U.S.A. (WA, OR). **Birds** C* 3 R1 *Porzana tabuensis* Rallidae Crake, spotless (American Samoa DPS) U.S.A. (AS), Australia, Fiji, Independent Samoa, Marquesas, Philippines, Society Islands, Tonga. C* 2 R1 *Oreomystis bairdi* Fringillidae Creeper, Kauai U.S.A. (HI). C* 3 R8 *Coccyzus americanus* Cuculidae Cuckoo, yellow-billed (Western U.S. DPS) U.S.A. (Lower 48 States), Canada, Mexico, Central and South America. C* 9 R1 *Gallicolumba stairi* Columbidae Ground-dove, friendly (American Samoa DPS) U.S.A. (AS), Independent Samoa. C* 3 R1 *Eremophila alpestris strigata* Alaudidae Horned lark, streaked U.S.A. (OR, WA), Canada (BC). C* 6 R5 *Calidris canutus rufa* Scolopacidae Knot, red U.S.A. (Atlantic coast), Canada, South America. C* 2 R7 *Brachyramphus brevirostris* Alcidae Murrelet, Kittlitz's U.S.A. (AK), Russia. C* 5 R8 *Synthliboramphus hypoleucus* Alcidae Murrelet, Xantus's U.S.A. (CA), Mexico. C* 8 R2 *Tympanuchus pallidicinctus* Phasianidae Prairie-chicken, lesser U.S.A. (CO, KA, NM, OK, TX). C* 6 R1 *Centrocercus urophasianus* Phasianidae Sage-grouse, greater (Columbia Basin DPS) U.S.A. (AZ, CA, CO, ID, MT, ND, NE, NV, OR, SD, UT, WA, WY), Canada (AB, BC, SK). C* 3 R1 *Oceanodroma castro* Hydrobatidae Storm-petrel, band-rumped (Hawaii DPS) U.S.A. (HI), Atlantic Ocean, Ecuador (Galapagos Islands), Japan. C* 5 R4 *Dendroica angelae* Emberizidae Warbler, elfin-woods U.S.A. (PR). **Reptiles** C* 2 R2 *Sceloporus arenicolus* Iguanidae Lizard, sand dune U.S.A. (TX, NM). C* 9 R3 *Sistrurus catenatus catenatus* Viperidae Massasauga (= rattlesnake), eastern U.S.A. (IA, IL, IN, MI, MO, MN, NY, OH, PA, WI), Canada. C* 3 R4 *Pituophis melanoleucus lodingi* Colubridae Snake, black pine U.S.A. (AL, LA, MS). C* 5 R4 *Pituophis ruthveni* Colubridae Snake, Louisiana pine U.S.A. (LA, TX). C* 3 R2 *Kinosternon sonoriense longifemorale* Kinosternidae Turtle, Sonoyta mud U.S.A. (AZ), Mexico. **Amphibians** C* 9 R8 *Rana luteiventris* Ranidae Frog, Columbia spotted (Great Basin DPS) U.S.A. (AK, ID, MT, NV, OR, UT, WA, WY), Canada (BC). C* 3 R8 *Rana muscosa* Ranidae Frog, mountain yellow-legged (Sierra Nevada DPS) U.S.A (CA, NV). C* 2 R1 *Rana pretiosa* Ranidae Frog, Oregon spotted U.S.A. (CA, OR, WA), Canada (BC). C* 11 R8 *Rana onca* Ranidae Frog, relict leopard U.S.A. (AZ, NV, UT). C* 3 R3 *Cryptobranchus alleganiensis bishopi* Crytobranchidae Hellbender, Ozark U.S.A. (AR, MO). C* 2 R2 *Eurycea waterlooensis* Plethodontidae Salamander, Austin blind U.S.A. (TX). C* 2 R2 *Eurycea naufragia* Plethodontidae Salamander, Georgetown U.S.A. (TX). C* 2 R2 *Eurycea chisholmensis* Plethodontidae Salamander, Salado U.S.A. (TX). C* 11 R8 *Bufo canorus* Bufonidae Toad, Yosemite U.S.A. (CA). C 3 R2 *Hyla wrightorum* Hylidae Treefrog, Arizona (Huachuca/Canelo DPS) U.S.A. (AZ), Mexico (Sonora). C* 8 R4 *Necturus alabamensis* Proteidae Waterdog, black warrior (= Sipsey Fork) U.S.A. (AL). **Fishes** C* 2 R2 *Gila nigra* Cyprinidae Chub, headwater U.S.A. (AZ, NM). C 5 R4 *Phoxinus saylori* Cyprinidae Dace, laurel U.S.A. (TN). C* 11 R6 *Etheostoma cragini* Percidae Darter, Arkansas U.S.A. (AR, CO, KS, MO, OK). C* 5 R4 *Etheostoma susanae* Percidae Darter, Cumberland U.S.A. (KY, TN). C* 5 R4 *Percina aurora* Percidae Darter, Pearl U.S.A. (LA, MS). C* 2 R4 *Etheostoma phytophilum* Percidae Darter, rush U.S.A. (AL). C* 2 R4 *Etheostoma moorei* Percidae Darter, yellowcheek U.S.A (AR). C* 2 R4 *Noturus crypticus* Ictaluridae Madtom, chucky U.S.A. (TN). C 5 R4 *Moxostoma* sp. Catostomidae Redhorse, sicklefin U.S.A. (GA, NC, TN). C* 2 R3 *Cottus* sp. Cottidae Sculpin, grotto U.S.A. (MO). C* 5 R2 *Notropis oxyrhynchus* Cyprinidae Shiner, sharpnose U.S.A. (TX). C* 5 R2 *Notropis buccula* Cyprinidae Shiner, smalleye U.S.A. (TX). C* 3 R2 *Catostomus discobolus yarrowi* Catostomidae Sucker, Zuni bluehead U.S.A. (AZ, NM). PSAT N/A R1 *Salvelinus malma* Salmonidae Trout, Dolly Varden U.S.A. (AK, WA), Canada, East Asia. **Clams** C 5 R4 *Villosa choctawensis* Unionidae Bean, Choctaw U.S.A. (AL, FL). C 2 R3 *Villosa fabalis* Unionidae Bean, rayed U.S.A. (IL, IN, KY, MI, NY, OH, TN, PA, VA, WV), Canada (ON). C 2 R4 *Fusconaia rotulata* Unionidae Ebonyshell, round U.S.A. (AL, FL). C* 2 R2 *Popenaias popei* Unionidae Hornshell, Texas U.S.A. (NM, TX), Mexico. C* 2 R4 *Ptychobranchus subtentum* Unionidae Kidneyshell, fluted U.S.A. (AL, KY, TN, VA). C 2 R4 *Ptychobranchus jonesi* Unionidae Kidneyshell, southern U.S.A. (AL, FL). C* 5 R4 *Lampsilis rafinesqueana* Unionidae Mucket, Neosho U.S.A. (AR, KS, MO, OK). C 2 R3 *Plethobasus cyphyus* Unionidae Mussel, sheepnose U.S.A. (AL, IA, IL, IN, KY, MN, MO, MS, OH, PA, TN, VA, WI, WV). C* 2 R4 *Margaritifera marrianae* Margaritiferidae Pearlshell, Alabama U.S.A. (AL). C* 5 R4 *Lexingtonia dolabelloides* Unionidae Pearlymussel, slabside U.S.A. (AL, KY, TN, VA). C 5 R4 *Pleurobema strodeanum* Unionidae Pigtoe, fuzzy U.S.A. (AL, FL). C* 2 R4 *Pleurobema hanleyianum* Unionidae Pigtoe, Georgia U.S.A. (AL, GA, TN). C 5 R4 *Fusconaia escambia* Unionidae Pigtoe, narrow U.S.A. (AL, FL). C 11 R4 *Quincuncina burkei* Unionidae Pigtoe, tapered U.S.A. (AL, FL). C 5 R4 *Hamiota* (= *Lampsilis* ) *australis* Unionidae Sandshell, southern U.S.A. (AL, FL). C 4 R3 *Cumberlandia monodonta* Margaritiferidae Spectaclecase U.S.A. (AL, AR, IA, IN, IL, KS, KY, MO, MN, NE, OH, TN, VA, WI, WV). C* 2 R4 *Elliptio spinosa* Unionidae Spinymussel, Altamaha U.S.A. (GA). **Snails** C 2 R4 *Pleurocera foremani* Pleuroceridae Hornsnail, rough U.S.A. (AL). C 8 R4 *Elimia melanoides* Pleuroceridae Mudalia, black U.S.A.

(AL)C* 9 R6 *Oreohelix peripherica wasatchensis* Oreohelicidae Mountainsnail, Ogden U.S.A. (UT). C* 8 R6 *Stagnicola bonnevillensis* Lymnaeidae Pondsnail, fat-whorled (= Bonneville) U.S.A. (UT). C* 2 R4 *Leptoxis foremani* (= *downei* ) Pleuroceridae Rocksnail, Interrupted (= Georgia) U.S.A. (GA, AL). C* 2 R1 *Ostodes strigatus* Potaridae Sisi snail U.S.A. (AS). C* 2 R2 *Pseudotryonia adamantina* Hydrobiidae Snail, Diamond Y Spring U.S.A. (TX). C* 2 R1 *Samoana fragilis* Partulidae Snail, fragile tree U.S.A. (GU, MP). C* 2 R1 *Partula radiolata* Partulidae Snail, Guam tree U.S.A. (GU). C* 2 R1 *Partula gibba* Partulidae Snail, Humped tree U.S.A. (GU, MP). C* 2 R1 *Partulina semicarinata* Achatinellidae Snail, Lanai tree U.S.A. (HI). C* 2 R1 *Partulina variabilis* Achatinellidae Snail, Lanai tree U.S.A. (HI). C* 2 R1 *Partula langfordi* Partulidae Snail, Langford's tree U.S.A. (MP). C* 2 R2 *Cochliopa texana* Hydrobiidae Snail, Phantom cave U.S.A. (TX). C* 2 R1 *Newcombia cumingi* Achatinellidae Snail, Newcomb's tree U.S.A. (Hl). C* 2 R1 *Eua zebrina* Partulidae Snail, Tutuila tree U.S.A. (AS). C* 2 R2 *Pyrgulopsis chupaderae* Hydrobiidae Springsnail, Chupadera U.S.A. (NM). C* 2 R8 *Pyrgulopsis notidicola* Hydrobiidae Springsnail, elongate mud meadows U.S.A. (NV). C* 11 R2 *Pyrgulopsis gilae* Hydrobiidae Springsnail, Gila U.S.A. (NM). C* 2 R2 *Tryonia circumstriata* (= *stocktonensis* ) Hydrobiidae Springsnail, Gonzales U.S.A. (TX). C* 8 R2 *Pyrgulopsis thompsoni* Hydrobiidae Springsnail, Huachuca U.S.A. (AZ), Mexico. C* 11 R2 *Pyrgulopsis thermalis* Hydrobiidae Springsnail, New Mexico U.S.A. (NM). C* 2 R2 *Pyrgulopsis morrisoni* Hydrobiidae Springsnail, Page U.S.A. (AZ). C* 2 R2 *Tryonia cheatumi* Hydrobiidae Springsnail (= Tryonia), Phantom U.S.A. (TX). C* 2 R2 *Pyrgulopsis bernardina* Hydrobiidae Springsnail, San Bernardino U.S.A. (AZ), Mexico (Sonora). C* 2 R2 *Pyrgulopsis trivialis* Hydrobiidae Springsnail, Three Forks U.S.A. (AZ). **Insects** C* 8 R1 *Nysius wekiuicola* Lygaeidae Bug, Wekiu U.S.A. (HI). C 3 R4 *Strymon acis bartrami* Lycaenidae Butterfly, Bartram's hairstreak U.S.A. (FL). C 3 R4 *Anaea troglodyta floridalis* Nymphalidae Butterfly, Florida leafwing U.S.A. (FL). C* 3 R1 *Hypolimnas octucula mariannensis* Nymphalidae Butterfly, Mariana eight-spot U.S.A. (GU, MP). C* 2 R1 *Vagrans egistina* Nymphalidae Butterfly, Mariana wandering U.S.A. (GU, MP). C* 6 R4 *Cyclargus thomasi bethunebakeri* Lycaenidae Butterfly, Miami blue U.S.A. (FL), Bahamas. C* 5 R4 *Glyphopsyche sequatchie* Limnephilidae Caddisfly, Sequatchie U.S.A. (TN). C 5 R4 *Pseudanophthalmus insularis* Carabidae Cave beetle, Baker Station (= insular) U.S.A. (TN). C* 5 R4 *Pseudanophthalmus caecus* Carabidae Cave beetle, Clifton U.S.A. (KY). C 11 R4 *Pseudanophthalmus colemanensis* Carabidae Cave beetle, Coleman U.S.A. (TN). C 5 R4 *Pseudanophthalmus fowlerae* Carabidae Cave beetle, Fowler's U.S.A. (TN). C* 5 R4 *Pseudanophthalmus frigidus* Carabidae Cave beetle, icebox U.S.A. (KY). C 5 R4 *Pseudanophthalmus tiresias* Carabidae Cave beetle, Indian Grave Point (= Soothsayer) U.S.A. (TN). C* 5 R4 *Pseudanophthalmus inquisitor* Carabidae Cave beetle, inquirer U.S.A. (TN). C* 5 R4 *Pseudanophthalmus troglodytes* Carabidae Cave beetle, Louisville U.S.A. (KY). C 5 R4 *Pseudanophthalmus paulus* Carabidae Cave beetle, Noblett's U.S.A. (TN). C* 5 R4 *Pseudanophthalmus parvus* Carabidae Cave beetle, Tatum U.S.A.

(KY)C* 3 R1 *Euphydryas editha taylori* Nymphalidae Checkerspot butterfly, Taylor's (= Whulge) U.S. A. (OR, WA), Canada (BC). C* 9 R1 *Megalagrion nigrohamatum nigrolineatum* Coenagrionidae Damselfly, blackline Hawaiian U.S.A. (HI). C* 2 R1 *Megalagrion leptodemas* Coenagrionidae Damselfly, crimson Hawaiian U.S.A. (HI). C* 2 R1 *Megalagrion nesiotes* Coenagrionidae Damselfly, flying earwig Hawaiian U.S.A. (HI). C* 2 R1 *Megalagrion oceanicum* Coenagrionidae Damselfly, oceanic Hawaiian U.S.A. (HI). C* 8 R1 *Megalagrion xanthomelas* Coenagrionidae Damselfly, orangeblack Hawaiian U.S.A. (HI). C* 2 R1 *Megalagrion pacificum* Coenagrionidae Damselfly, Pacific Hawaiian U.S.A. (HI). C* 2 R8 *Dinacoma caseyi* Scarabidae June beetle, Casey's U.S.A. (CA). C 5 R8 *Ambrysus funebris* Naucoridae Naucorid bug (= Furnace Creek), Nevares Spring U.S.A. (CA). C* 2 R1 *Drosophila attigua* Drosophilidae fly, Picture-wing U.S.A. (HI). C* 2 R1 *Drosophila digressa* Drosophilidae fly, Picture-wing [unnamed] U.S.A. (HI). C* 8 R2 *Heterelmis stephani* Elmidae Riffle beetle, Stephan's U.S.A. (AZ). C* 8 R3 *Hesperia dacotae* Hesperiidae Skipper, Dakota U.S.A. (MN, IA, SD, ND, IL), Canada. C* 5 R1 *Polites mardon* Hesperiidae Skipper, Mardon U.S.A. (CA, OR, WA). C* 8 R6 *Cicindela albissima* Cicindelidae Tiger beetle, Coral Pink Sand Dunes U.S.A. (UT). C* 5 R4 *Cicindela highlandensis* Cicindelidae Tiger beetle, highlands U.S.A. (FL). **Arachnids** C* 2 R2 *Cicurina wartoni* Dictynidae Meshweaver, Warton cave U.S.A. (TX). **Crustaceans** C 2 R2 *Gammarus hyalleloides* Gammaridae Amphipod, diminutive U.S.A. (TX). C* 5 R1 *Metabetaeus lohena* Alpheidae Shrimp, anchialine pool U.S.A. (HI). C* 5 R1 *Palaemonella burnsi* Palaemonidae Shrimp, anchialine pool U.S.A. (HI). C* 5 R1 *Procaris hawaiana* Procarididae Shrimp, anchialine pool U.S.A. (HI). C* 4 R1 *Vetericaris chaceorum* Procaridae Shrimp, anchialine pool U.S.A. (HI). C* 11 R4 *Typhlatya monae* Atyidae Shrimp, troglobitic groundwater U.S.A. (PR), Barbuda, Dominican Republic. **Flowering Plants** C* 11 R8 *Abronia alpina* Nyctaginaceae Sand-verbena, Ramshaw Meadows U.S.A. (CA). C* 8 R4 *Arabis georgiana* Brassicaceae Rockcress, Georgia U.S.A. (AL, GA). C* 11 R4 *Argythamnia blodgettii* Euphorbiaceae Silverbush, Blodgett's U.S.A. (FL). C* 3 R1 *Artemisia campestris* var. *wormskioldii* Asteraceae Wormwood, northern U.S.A. (OR, WA). C* 2 R1 *Astelia waialealae* Liliaceae Pa'iniu U.S.A. (HI). C* 11 R6 *Astragalus tortipes* Fabaceae Milk-vetch, Sleeping Ute U.S.A. (CO). C* 2 R1 *Bidens amplectens* Asteraceae Ko'oko'olau U.S.A. (HI). C* 3 R1 *Bidens campylotheca pentamera* Asteraceae Ko'oko'olau U.S.A. (HI). C* 3 R1 *Bidens campylotheca waihoiensis* Asteraceae Ko'oko'olau U.S.A. (HI). C* 8 R1 *Bidens conjuncta* Asteraceae Ko'oko'olau U.S.A. (HI). C* 3 R1 *Bidens micrantha ctenophylla* Asteraceae Ko'oko'olau U.S.A. (HI). C* 8 R4 *Brickellia mosieri* Asteraceae Brickell-bush, Florida U.S.A. (FL). C* 2 R1 *Calamagrostis expansa* Poaceae Reedgrass, Maui U.S.A. (HI). C* 2 R1 *Calamagrostis hillebrandii* Poaceae Reedgrass, Hillebrand's U.S.A. (HI). C* 5 R4 *Calliandra locoensis* Mimosaceae No common name U.S.A. (PR). C* 5 R8 *Calochortus persistens* Liliaceae Mariposa lily, Siskiyou U.S.A. (CA, OR). C* 5 R4 *Calyptranthes estremerae* Myrtaceae No common name U.S.A. (PR). C* 2 R1 *Canavalia napaliensis* Fabaceae 'Awikiwiki U.S.A. (HI). C* 2 R1 *Canavalia pubescens* Fabaceae 'Awikiwiki U.S.A. (HI). C* 8 R1 *Castilleja christii* Scrophulariaceae Paintbrush, Christ's U.S.A. (ID). C* 9 R4 *Chamaecrista lineata* var. *keyensis* Fabaceae Pea, Big Pine partridge U.S.A. (FL). C* 12 R4 *Chamaesyce deltoidea pinetorum* Euphorbiaceae Sandmat, pineland U.S.A. (FL). C* 9 R4 *Chamaesyce deltoidea serpyllum* Euphorbiaceae Spurge, wedge U.S.A. (FL). C* 2 R1 *Chamaesyce eleanoriae* Euphorbiaceae 'Akoko U.S.A. (HI). C* 3 R1 *Chamaesyce remyi* var. *kauaiensis* Euphorbiaceae 'Akoko U.S.A. (HI). C* 3 R1 *Chamaesyce remyi* var. *remyi* Euphorbiaceae 'Akoko U.S.A. (HI). C* 2 R1 *Charpentiera densiflora* Amaranthaceae Papala U.S.A. (HI). C* 6 R8 *Chorizanthe parryi* var. *fernandina* Polygonaceae Spineflower, San Fernando Valley U.S.A. (CA). C* 2 R4 *Chromolaena frustrata* Asteraceae Thoroughwort, Cape Sable U.S.A. (FL). C* 2 R4 *Consolea corallicola* Cactaceae Cactus, Florida semaphore U.S.A. (FL). C* 5 R4 *Cordia rupicola* Boraginaceae No common name U.S.A. (PR), Anegada. C* 2 R1 *Cyanea asplenifolia* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea calycina* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea eleeleensis* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea kuhihewa* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea kunthiana* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea lanceolata* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea obtusa* Campanulaceae Haha U.S.A. (HI). C* 2 R1 *Cyanea tritomantha* Campanulaceae 'aku 'aku U.S.A. (HI). C* 2 R1 *Cyrtandra filipes* Gesneriaceae Ha'iwale U.S.A. (HI). C* 2 R1 *Cyrtandra kaulantha* Gesneriaceae Ha'iwale U.S.A. (HI). C* 2 R1 *Cyrtandra oenobarba* Gesneriaceae Ha'iwale U.S.A. (HI). C* 2 R1 *Cyrtandra oxybapha* Gesneriaceae Ha'iwale U.S.A. (HI). C* 2 R1 *Cyrtandra sessilis* Gesneriaceae Ha'iwale U.S.A. (HI). C* 3 R4 *Dalea carthagenensis* var. *floridana* Fabaceae Prairie-clover, Florida U.S.A. (FL). C* 5 R5 *Dichanthelium hirstii* Poaceae Panic grass, Hirsts' U.S.A. (DE, GA, NC, NJ). C* 5 R4 *Digitaria pauciflora* Poaceae Crabgrass, Florida pineland U.S.A. (FL). C* 3 R1 *Dubautia imbricata imbricata* Asteraceae Na'ena'e U.S.A. (HI). C* 3 R1 *Dubautia plantaginea magnifolia* Asteraceae Na'ena'e U.S.A. (HI). C* 2 R1 *Dubautia waialealae* Asteraceae Na'ena'e U.S.A. (HI). C* 3 R2 *Echinomastus erectocentrus* var. *acunensis* Cactaceae Cactus, Acuna U.S.A. (AZ), Mexico. C* 8 R2 *Erigeron lemmonii* Asteraceae Fleabane, Lemmon U.S.A. (AZ). C* 2 R1 *Eriogonum codium* Polygonaceae Buckwheat, Umtanum Desert U.S.A. (WA). C 6 R8 *Eriogonum corymbosum* var. *nilesii* Polygonaceae Buckwheat, Las Vegas U.S.A. (NV). C 2 R8 *Eriogonum diatomaceum* Polygonaceae Buckwheat, Churchill Narrows U.S.A. (NV). C* 5 R8 *Eriogonum kelloggii* Polygonaceae Buckwheat, Red Mountain U.S.A. (CA). C* 2 R1 *Festuca hawaiiensis* Poaceae No common name U.S.A. (HI). C* 11 R2 *Festuca ligulata* Poaceae Fescue, Guadalupe U.S.A. (TX), Mexico. C* 2 R1 *Gardenia remyi* Rubiaceae Nanu U.S.A. (HI). C* 8 R1 *Geranium hanaense* Geraniaceae Nohoanu U.S.A. (HI). C* 8 R1 *Geranium hillebrandii* Geraniaceae Nohoanu U.S.A. (HI). C* 5 R1 *Geranium kauaiense* Geraniaceae Nohoanu U.S.A. (HI). C* 5 R4 *Gonocalyx concolor* Ericaceae No common name U.S.A. (PR). C 5 R4 *Harrisia aboriginum* Cactaceae Pricklyapple, aboriginal (shellmound applecactus) U.S.A. (FL). C* 5 R8 *Hazardia orcuttii* Asteraceae Orcutt's hazardia U.S.A. (CA), Mexico. C* 2 R1 *Hedyotis fluviatilis* Rubiaceae Kampua'a U.S.A. (HI). C* 5 R4 *Helianthus verticillatus* Asteraceae Sunflower, whorled U.S.A. (AL, GA, TN). C* 5 R2 *Hibiscus dasycalyx* Malvaceae Rose-mallow, Neches River U.S.A. (TX). C* 9 R4 *Indigofera mucronata* var. *keyensis* Fabaceae Indigo, Florida U.S.A. (FL). C 2 R6 *Ipomopsis polyantha* Polemoniaceae Skyrocket, Pagosa U.S.A. (CO). C* 5 R8 *Ivesia webberi* Rosaceae Ivesia, Webber U.S.A. (CA, NV). C* 3 R1 *Joinvillea ascendens ascendens* Joinvilleaceae 'Ohe U.S.A. (HI). C* 2 R1 *Keysseria* (= *Lagenifera* ) *erici* Asteraceae No common name U.S.A. (HI). C* 8 R1 *Keysseria* (= *Lagenifera* ) *helenae* Asteraceae No common name U.S.A. (HI). C* 2 R1 *Korthalsella degeneri* Viscaceae Hulumoa U.S.A. (HI). C* 2 R1 *Labordia helleri* Loganiaceae Kamakahala U.S.A. (HI). C* 2 R1 *Labordia pumila* Loganiaceae Kamakahala U.S.A. (HI). C* 5 R4 *Leavenworthia crassa* Brassicaceae Gladecress, unnamed U.S.A. (AL). C* 2 R2 *Leavenworthia texana* Brassicaceae Gladecress, Texas golden U.S.A. (TX). C* 5 R4 *Lesquerella globosa* Brassicaceae Bladderpod, Short's U.S.A. (IN, KY, TN). C* 2 R4 *Linum arenicola* Linaceae Flax, sand U.S.A. (FL). C* 3 R4 *Linum carteri* var. *carteri* Linaceae Flax, Carter's small-flowered U.S.A. (FL). C* 8 R1 *Lysimachia daphnoides* Primulaceae Lehua makanoe U.S.A. (HI). C* 2 R1 *Melicope christophersenii* Rutaceae Alani U.S.A. (HI). C* 2 R1 *Melicope degeneri* Rutaceae Alani U.S.A. (HI). C* 2 R1 *Melicope hiiakae* Rutaceae Alani U.S.A. (HI). C* 2 R1 *Melicope makahae* Rutaceae Alani U.S.A. (HI). C* 2 R1 *Melicope paniculata* Rutaceae Alani U.S.A. (HI). C* 2 R1 *Melicope puberula* Rutaceae Alani U.S.A. (HI). C* 2 R1 *Myrsine fosbergii* Myrsinaceae Kolea U.S.A. (HI). C* 2 R1 *Myrsine mezii* Myrsinaceae Kolea U.S.A. (HI). C* 2 R1 *Myrsine vaccinioides* Myrsinaceae Kolea U.S.A. (HI). C* 8 R5 *Narthecium americanum* Liliaceae Asphodel, bog U.S.A. (DE, NC, NJ, NY, SC). C* 2 R1 *Nothocestrum latifolium* Solanaceae 'Aiea U.S.A. (HI). C* 2 R1 *Ochrosia haleakalae* Apocynaceae Holei U.S.A. (HI). C* 3 R2 *Pediocactus peeblesianus* var. *fickeiseniae* Cactaceae Cactus, Fickeisen plains U.S.A. (AZ). C* 2 R6 *Penstemon debilis* Scrophulariaceae Beardtongue, Parachute U.S.A. (CO). C* 6 R6 *Penstemon scariosus* var. *albifluvis* Scrophulariaceae Beardtongue, White River U.S.A. (CO, UT). C* 2 R1 *Peperomia subpetiolata* Piperaceae 'Ala 'ala wai nui U.S.A. (HI). C 5 R8 *Phacelia stellaris* Hydrophyllaceae Phacelia, Brand's U.S.A. (CA), Mexico. C* 8 R6 *Phacelia submutica* Hydrophyllaceae Phacelia, DeBeque U.S.A. (CO). C* 2 R1 *Phyllostegia bracteata* Lamiaceae No common name U.S.A. (HI). C* 8 R1 *Phyllostegia floribunda* Lamiaceae No common name U.S.A. (HI). C* 2 R1 *Phyllostegia hispida* Lamiaceae No common name U.S.A. (HI). C* 5 R1 *Physaria tuplashensis* Brassicaceae Bladderpod, White Bluffs U.S.A. (WA). C* 2 R1 *Pittosporum napaliense* Pittosporaceae Ho'awa U.S.A. (HI). C* 5 R4 *Platanthera integrilabia* Orchidaceae Orchid, white fringeless U.S.A. (AL, GA, KY, MS, NC, SC, TN, VA). C* 3 R1 *Platydesma cornuta* var. *cornuta* Rutaceae No common name U.S.A. (HI). C* 3 R1 *Platydesma cornuta* var. *decurrens* Rutaceae No common name U.S.A. (HI). C* 2 R1 *Platydesma remyi* Rutaceae No common name U.S.A. (HI). C* 2 R1 *Platydesma rostrata* Rutaceae Pilo kea lau li'i U.S.A. (HI). C 2 R1 *Pleomele fernaldii* Agavaceae Hala pepe U.S.A. (HI). C* 2 R1 *Pleomele forbesii* Agavaceae Hala pepe U.S.A. (HI). C* 11 R8 *Potentilla basaltica* Rosaceae Cinquefoil, Soldier Meadow U.S.A. (NV). C* 2 R1 *Pritchardia hardyi* Asteraceae Lo'ulu U.S.A. (HI). C* 3 R1 *Pseudognaphalium* (= *Gnaphalium* ) *sandwicensium* var. *molokaiense* Asteraceae 'Ena'ena U.S.A. (HI). C* 2 R1 *Psychotria grandiflora* Rubiaceae Kopiko U.S.A. (HI). C* 3 R1 *Psychotria hexandra* ssp. *oahuensis* var. *oahuensis* Rubiaceae Kopiko U.S.A. (HI). C* 2 R1 *Psychotria hobdyi* Rubiaceae Kopiko U.S.A. (HI). C* 2 R1 *Pteralyxia macrocarpa* Apocynaceae Kaulu U.S.A. (HI). C* 2 R1 *Ranunculus hawaiensis* Ranunculaceae Makou U.S.A. (HI). C* 2 R1 *Ranunculus mauiensis* Ranunculaceae Makou U.S.A. (HI). C* 8 R8 *Rorippa subumbellata* Brassicaceae Cress, Tahoe yellow U.S.A. (CA, NV). C* 2 R1 *Schiedea attenuata* Caryophyllaceae No common name U.S.A. (HI). C* 2 R1 *Schiedea pubescens* Caryophyllaceae Ma'oli'oli U.S.A. (HI). C* 2 R1 *Schiedea salicaria* Caryophyllaceae No common name U.S.A. (HI). C* 5 R8 *Sedum eastwoodiae* Crassulaceae Stonecrop, Red Mountain U.S.A. (CA). C* 2 R1 *Sicyos macrophyllus* Cucurbitaceae 'Anunu U.S.A. (HI). C 12 R4 *Sideroxylon reclinatum* ssp. *austrofloridense* Sapotaceae Bully, Everglades U.S.A. (FL). C* 8 R1 *Solanum nelsonii* Solanaceae Popolo U.S.A. (HI). C 8 R4 *Solidago plumosa* Asteraceae Goldenrod, Yadkin River U.S.A. (NC). C* 2 R1 *Stenogyne cranwelliae* Lamiaceae No common name U.S.A. (HI). C* 2 R1 *Stenogyne kealiae* Lamiaceae No common name U.S.A. (HI). C* 8 R4 *Symphyotrichum georgianum* Asteraceae Aster, Georgia U.S.A. (AL, FL, GA, NC, SC). C* 2 R1 *Zanthoxylum oahuense* Rutaceae A'e U.S.A. (HI). **Ferns and Allies** C* 8 R1 *Christella boydiae* (= *Cyclosorus boydiae* var. *boydiae* + *Cyclosorus boydiae kipahuluensis* ) Thelypteridaceae No common name U.S.A. (HI). C* 2 R1 *Doryopteris takeuchii* Pteridaceae No common name U.S.A. (HI). C* 2 R1 *Huperzia* (= *Phlegmariurus* ) *stemmermanniae* Lycopodiaceae Wawae'iole U.S.A. (HI). C* 3 R1 *Microlepia strigosa* var. *mauiensis* (= *Microlepia mauiensis* ) Dennstaedtiaceae Palapalai U.S.A. (HI). Table 2.—Animals and Plants Formerly Candidates or Formerly Proposed for Listing [Note: See end of Supplementary Information for an explanation of symbols used in this table.0 Status Code Expl. Lead region Scientific name Family Common name Historical range **Fishes** Rp A R8 *Gila bicolor vaccaceps* Cyprinidae Chub, Cowhead tui chub U.S.A. (CA). Rc N R6 *Thymallus arcticus* Salmonidae Grayling, Fluvial arctic (upper Missouri River DPS) U.S.A. (MT, WY). **Insects** Rc U R4 *Pseudanophthalmus major* Carabidae Cave beetle, Beaver U.S.A. (KY). Rc A, U R4 *Pseudanophthalmus inexpectatus* Carabidae Cave beetle, surprising U.S.A. (KY). Rc U R6 *Zaitzevia thermae* Elmidae Beetle, Warm Spring Zaitzevian riffle U.S.A. (MT). **Flowering Plants** Rp A R6 *Penstemon grahamii* Scrophulariaceae Beardtongue, Graham U.S.A. (CO, UT). Rc A R1 *Erigeron basalticus* Asteraceae Daisy, basalt U.S.A. (WA). **Ferns and Allies** Rc A, I R1 *Botrychium lineare* Ophioglossaceae Moonwort, slender U.S.A. (AK, CA, CO, ID, MT, OR, WA), Canada (AB, BC, NB, QC). [FR Doc. E7-23416 Filed 12-5-07; 8:45 am] BILLING CODE 4310-55-P 72 234 Thursday, December 6, 2007 Rules and Regulations Part IV Department of Health and Human Services Food and Drug Administration 21 CFR Parts 20, 25, 201, et al. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 20, 25, 201, 202, 207, 225, 226, 500, 510, 511, 515, 516, 558, and 589 [Docket No. 2006N-0067] RIN 0910-AF67 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize the U.S. Food and Drug Administration (FDA, the agency) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement section 572 of the act entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” These regulations establish administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species. DATES: This rule is effective February 19, 2008. FOR FURTHER INFORMATION CONTACT: Bernadette Dunham, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail: *Bernadette.Dunham@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In enacting the MUMS act (Pub. L. 108-282), Congress sought to encourage the development of animal drugs that are currently unavailable to minor species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major species afflicted with uncommon diseases or conditions (minor use). Congress recognized that the markets for drugs intended to treat these species, diseases, or conditions are so small that there are often insufficient economic incentives to motivate sponsors to develop data to support approvals. Further, Congress recognized that some minor species populations are too small or their management systems too diverse to make it practical to conduct traditional studies to demonstrate safety and effectiveness of animal drugs for such uses. As a result of these limitations, sponsors have generally not been willing or able to collect data to support legal marketing of drugs for these species, diseases, or conditions. Consequently, Congress enacted the MUMS act, which amended the Federal Food, Drug, and Cosmetic Act to provide incentives to develop new animal drugs for minor species and minor use, while still ensuring appropriate safeguards for animal and human health. The major incentives of the MUMS act include the following:

(1)Designation, established by section 573 of the act (21 U.S.C. 360ccc-2), which provides for eligibility for grants and contracts to defray the costs of qualified safety and effectiveness testing expenses and manufacturing expenses incurred in the development of designated new animal drugs. Designation also provides for eligibility for a 7-year period of exclusive marketing rights to enable sponsors to recover costs of drug development without competition. FDA published final regulations implementing the designation provision of the act on July 26, 2007 (72 FR 41010) (the designation final rule).

(2)Conditional approval, established by section 571 of the act (21 U.S.C. 360ccc), which provides for animal drug marketing after all safety and manufacturing components of a new animal drug approval have met the standards of section 512 of the act (21 U.S.C. 360b). For the effectiveness component, a reasonable expectation of effectiveness must be established, after which sponsors have up to 5 years to complete the demonstration of effectiveness by the standards of section 512 of the act and achieve a full approval. Regulations to implement the conditional approval provision will be proposed in the future.

(3)Indexing, established under section 572 of the act (21 U.S.C. 360ccc-1), which provides for the legal marketing of unapproved new animal drugs intended for use in a minor species through an integrated process of agency and expert panel review. At this time, FDA is issuing final regulations implementing the indexing provisions of the MUMS act. These regulations establish procedures and criteria for index listing a new animal drug for use in a minor species. They describe a process whereby the agency makes a determination regarding the following:

(1)The eligibility of a new animal drug,

(2)the selection of a qualified expert panel, and

(3)the findings of the qualified expert panel. In the **Federal Register** of August 22, 2006 (71 FR 48840), FDA issued proposed regulations to implement section 572 of the act (21 U.S.C. 360ccc-1). The proposed rule initially provided for a 90-day public comment period during which the agency received several comments asserting that 90 days was not an adequate amount of time to prepare and submit meaningful comments. In response to this, in the **Federal Register** of October 2, 2006 (71 FR 57892), FDA extended the comment period allowing an additional 30 days of public comment. II. Major Changes to the Proposed Rule After considering public comments FDA has made the following changes to the proposed rule: In § 516.123, paragraph

(b)has been revised to read: “The written notice will include information for scheduling the informal conference and state that a written request for a conference must be made within 60 days of the date FDA sends its notice.” Also, paragraph

(c)has been revised to read: “Within 45 days of receiving a request for an informal conference, FDA will schedule and hold the informal conference at a time agreeable to both FDA and the person making the request.” In § 516.123, proposed paragraphs

(j)and (l)(3) have been deleted and paragraph

(k)has been revised to read: “The presiding officer will prepare a written report regarding the subject of the informal conference that states and describes the basis for his or her findings. Whenever time permits, the parties to the informal conference will have 30 days to review and comment on the report.” In section 516.141, paragraph (b)(1) has been revised to read: “A qualified expert panel member must be an expert qualified by training and experience to evaluate a significant aspect of target animal safety or effectiveness of the new animal drug under consideration.” In addition, FDA has made two technical corrections to the proposed rule. The first one is in part 25 (21 CFR part 25). An amendment to § 25.33 was proposed as a conforming change to add index listed drugs to the list of actions for animal drugs which may be categorically excluded from the preparation of an environmental assessment. However, the agency neglected to propose a corresponding amendment to § 25.20 to also add index listed drugs to the list of actions requiring preparation of an environmental assessment. Therefore, this final rule contains a conforming change to § 25.20(m) to correct this omission. The second technical correction is in part 207 (21 CFR part 207). Amendments to §§ 207.21 and 207.35 were proposed as conforming changes to include index listed drugs under the drug registration and listing provisions of part 207. However, the agency neglected to propose a corresponding amendment to § 207.20(c) which describes who must register and submit a drug list. Therefore, this final rule contains a conforming change to § 207.20(c) to correct this omission. III. Comments The agency received comments from six organizations on the August 22, 2006, proposal. Comments were received from a trade organization representing new animal drug manufacturers, a trade organization representing pet product manufacturers, an animal feed manufacturer, a professional association representing veterinarians, an aquaculture trade association, and a U.S. Government agency. All of the comments supported the purpose of the proposed regulations. Four comments generally supported the structure and scope of the proposed regulations. Four comments expressed concern regarding the apparent complexity of the proposed regulations and encouraged the agency to demonstrate considerable flexibility in their implementation. The issue of greatest concern in these four comments involved the formation and functioning of the qualified expert panels proposed in the regulations—particularly the application of the conflict of interest provisions to potential panel members. The agency understands the time and effort involved in providing comments on the proposed regulations and greatly appreciates this effort. The general issues noted previously, as well as a number of more specific issues raised in the comments, are addressed as follows: (Comment 1) As noted, four comments expressed considerable concern over the apparent complexity of the process described in the proposed regulations. While most apparently accepted the need for this complexity as a direct consequence of the statutory requirements of section 572 of the statute, these comments uniformly expressed a desire that the agency be as flexible as possible in implementing the potentially more burdensome aspects of the regulations and encouraged the agency to provide as much guidance as possible to potential sponsors regarding their implementation. (Response) The agency agrees that it should be flexible, to the extent allowable under the law, in implementing the indexing program. In order to further clarify the indexing process and assist requestors and potential requestors, the agency intends to develop guidance documents regarding various parts of the process as soon after finalization of implementing regulations as resources permit. (Comment 2) One comment stated that the proposed indexing process is overly complex and too similar to the new animal drug approval process. This comment suggested that the proposed process be discarded and replaced with an alternative process that would emphasize general compounds rather than specific drug products. (Response) The indexing process established by the MUMS act is for drug products rather than general compounds. For example, section 572(c)(1) of the act describes how to make a request for a determination of whether “a new animal drug” may be eligible for indexing. Moreover, that provision requires that the requestor submit information specific to a new animal drug, rather than for general compounds, such as information regarding the components and composition of the new animal drug and a description of the methods, facilities, and controls used for manufacturing the new animal drug. A request for addition to the index under section 572(d)(1) of the act is made “with respect to a new animal drug for which [FDA] has a made a determination of eligibility.” Additionally, in considering a request for eligibility for indexing, the statute requires that the request not involve the same drug in the same dosage form for the same intended use as a drug that is already approved or conditionally approved. Based on this and similar language in the statute, the agency believes, with respect to the indexing of new animal drugs, that indexing should follow the product-specific model of new animal drug approval. However, the agency notes that this basic statutory construction does not necessarily preclude information supporting the indexing of one product from being used to support the indexing of other products, provided the information is relevant to such products, and provided the party or parties gathering the information allow its use for that purpose if such information is proprietary. (Comment 3) Four comments expressed concern about the formation and operation of qualified expert panels and, in particular, the application of the conflict of interest provisions of the regulations. (Response) The agency is aware of the potential scarcity of experts to serve on some expert panels. It also wants to assure the integrity of this fundamental part of the indexing process, so that the agency can have confidence in the information and recommendations it receives from the expert panel and the public can trust the agency's decisions based on that information and recommendations. The purpose of obtaining information regarding potential experts is to enable the agency to make an informed judgment, on a case-by-case basis, regarding whether a financial or other interest could impair the person's objectivity in serving on the panel or could create an unfair competitive advantage for a person or organization. Under the proposal, and not changed in the final rule, even if there is an otherwise disqualifying financial interest, FDA has discretion to nonetheless allow the person to serve as a member of the expert panel. In making its determinations on the subject of conflicts of interest, the agency will be cognizant of both the need to assure the integrity of the expert panel process and the need to attract qualified experts to serve on these panels. (Comment 4) Three comments suggested that the agency needs to consider the expertise of the entire panel as a whole, and not each panelist individually, when implementing the requirement that a panel be composed of “experts qualified by training and experience to evaluate the safety and effectiveness of the new animal drug under consideration.” (Response) It is the intention of the agency to consider the expertise of the entire panel as a whole, as suggested in the comment. Proposed § 516.141(b)(5) says that the “panel, as a whole, is qualified by training and experience to evaluate the safety and effectiveness of the new animal drug under consideration.” However, paragraph (b)(1) of the same regulation could be read as requiring that *each* individual member of a panel must meet this requirement, that is, each member of an expert panel is expected to be qualified to independently assess *all* aspects of a particular product's target animal safety *and* effectiveness. This was not the agency's intention and, therefore, the language of § 516.141(b)(1) has been revised to read: “A qualified expert panel member must be an expert qualified by training and experience to evaluate a significant aspect of target animal safety or effectiveness of the new animal drug under consideration.” (Comment 5) Two comments suggested that the scope of review of the expert panel might be expanded to include elements of food safety and/or environmental safety. (Response) The MUMS act clearly established several distinct steps in the review process for indexing new animal drugs. One step is the determination of eligibility for indexing, which involves an evaluation of most of the indexing criteria, including food, user and occupational safety and environmental impacts. This evaluation is to be performed by the agency prior to the formation of a qualified expert panel. After the agency makes its determination regarding eligibility, a subsequent step is the formation and operation of a qualified expert panel. The responsibilities of the expert panel are set forth in section 572(d)(2) of the act: Evaluate and make findings regarding target animal safety and effectiveness; provide information from which labeling can be written; and recommend whether the new animal drug should be over the counter, prescription, or veterinary feed directive. Given this statutory construction, it would not be feasible or appropriate for the qualified expert panel to review or to comment upon aspects of product safety outside the scope of target animal safety and effectiveness. However, sponsors are free to involve experts, not serving in the capacity of qualified expert panel members, in the preparation of information submitted to the agency in support of a determination of eligibility for indexing. (Comment 6) Several comments stated that 30 days is not a sufficient amount of time for a sponsor to submit a written response to the denial of a request for determination of eligibility for indexing or a denial of a request for indexing and indicated that this time period should be extended to 90 days. (Response) While the agency agrees that 30 days may not be an adequate period for a written response to a denial, the agency also notes that the proposed regulation did not explicitly limit a sponsor to 30 days for a written response. Instead, it proposed that a sponsor must inform the agency within 30 days that it wishes to avail itself of the opportunity for an informal conference. Within 30 days of receipt of such a request, the agency would schedule such a conference at a time agreeable to both the agency and the sponsor, and the sponsor would be required to submit a written response at least two weeks prior to the scheduled meeting. The agency continues to believe that it is appropriate to have a two-step process for scheduling an informal conference. This would involve an initial period of time during which a sponsor must signify their desire to have an informal conference followed by a second period of time during which the conference will actually be scheduled. The agency also continues to believe that it needs to receive the written response from a sponsor a minimum of two weeks prior to an informal conference. However, the agency has extended the initial period during which sponsors must request an informal conference from 30 days to 60 days to permit sponsors additional time to consider the need for such a conference. The agency has also extended the second period of time during which the agency will schedule a requested informal conference from 30 days to 45 days. With these revisions, a sponsor may take as long as 60 days to request an informal conference, may request that the conference not be held until 45 days after such a request and need not submit the written response in support of the conference until two weeks before the conference. This process will generally permit sponsors to have as much as 90 days to prepare a written response, if they feel they need it. Accordingly, the language of § 516.123(b) and

(c)is revised to read as follows:

(b)The written notice will include information for scheduling the informal conference and state that a written request for a conference must be made within 60 days of the date FDA sends its notice.

(c)Within 45 days of receiving a request for an informal conference, FDA will schedule and hold the informal conference at a time agreeable to both FDA and the person making the request. (Comment 7) Two comments stated that the language of § 516.123 indicated that informal conferences were, in fact, rather formal and one commentor asked for clarification of the reason for using the term “informal” in this context. (Response) The statute and the proposed and final regulation use the phrase “informal conference.” The agency believes that the purpose of the statutory use of the term “conference” in section 572 of the act is to be distinct from the term “hearing” which is used in the context of similar denial or withdrawal decisions regarding products involved in the new animal drug approval process under section 512 of the act. The hearing referred to in section 512 of the act has been clarified by regulation to be a formal evidentiary hearing under 21 CFR part 12. The agency believes that the purpose of the statutory use of the word “informal” in section 572 of the act is to draw a further distinction between the formal evidentiary hearing under 512 of the act and the informal conference under section 572. FDA believes that the process for the informal conference set forth in § 516.123 is appropriately tailored. While much less formal than the part 12 hearings, it still ensures that there is a meaningful opportunity for parties to express their views, a neutral decision maker, and an administrative record for judicial review if the final agency decision is challenged in court. Moreover, by describing the process in a regulation, the parties in the informal conference will have a common understanding of how it will operate, fostering an orderly operation and reducing the potential for disagreements over the process. (Comment 8) One comment questioned the inclusion of the requirement for an estimation of annual product distribution in proposed § 516.129(c)(6). (Response) In accordance with section 572(c)(1)(A) of the act, the request for determination of eligibility for indexing must include the anticipated annual distribution of the new animal drug. This information would be useful, for example, in estimating the extent of environmental and user exposure in the process of determining environmental and user safety. (Comment 9) One comment suggested that requestors of an informal conference have an opportunity to read and respond to the minutes of an informal conference within 30 days. (Response) This comment raises two issues which the agency needs to address and clarify in the final regulation. The first issue relates to whether the person requesting an informal conference should have the opportunity to review and comment on a summary of the informal conference. The agency believes that the requestor should have such an opportunity. In framing the comment in the context of the “minutes of an informal conference,” the comment also raises an issue regarding what sort of a summary of the informal conference the person requesting an informal conference should have an opportunity to review and comment on. In this context, the agency has reconsidered the requirement in the proposed regulation for the preparation of both a “written summary” of the conference and a “written report” of the conference. The latter was intended to parallel the written report associated with a 21 CFR part 16 informal hearing, and was intended to be more comprehensive than simply a “written summary of the conference” or the “minutes of an informal conference” as expressed in the comment. The agency believes that the requestor of an informal conference should have an opportunity to review and comment on the written report of the informal conference. We have revised § 516.123(k) to provide for such a review whenever time permits. That being the case, the agency believes that a written summary of the informal conference is superfluous and this requirement, which was proposed by means of §§ 516.123(j) and 516.123(l)(3), has been removed from the final regulation. (Comment 10) Two comments requested clarification of different aspects of the early, non-food life-stage provision of the proposed regulations. (Response) As stated in the preamble to the proposed regulations, the early, non-food life-stage provision of the statute and implementing regulations will be applicable only in limited circumstances, and the safety of food eventually derived from such animals will be determined in accordance with the safety standards of 512(d) of the act. The agency has currently identified only early, non-food life stages of some aquatic species, such as certain fish eggs and mollusc larvae, as likely to be able to meet this standard. There is no explicit statutory restriction of this provision to aquatic minor species, although the statutory restriction to products intended only for use in a hatchery, tank, pond or other similar contained man-made structure tends to exclude terrestrial species. The agency has yet to identify a terrestrial species that it feels is likely to qualify under this provision of the statute, but has not ruled out the possibility that some terrestrial minor species could qualify. The agency is unable at this time to establish any general criteria regarding ages, sizes, amount of time between early, non-food life stages and later food life stages, or biological developmental processes that can predict the applicability of this provision of the act. Nor is the agency able to make any general statements regarding how much information of what sort will be necessary to meet the requirements of 512(d) of the statute. These issues depend upon the drug and the minor species involved in each particular case. (Comment 11) One comment asserted that the revenue to be expected from some segments of the minor species market may not justify the estimated administrative costs for indexing cited in the proposed rule. The comment is concerned with needed medicated feeds, especially for zoo and laboratory animals. The comment proposes that an “exemption” should be provided in cases where sales will not offset these costs. Specifically, the comment suggests that a threshold sales level should be set ($100,000 is recommended) above which indexing would be required, but below which an expanded policy of regulatory discretion would be provided. The comment also notes that the inability to alter the nutrition and physical form of an approved medicated feed to suit use in a minor species limits the utility of the existing regulatory discretion policy (Compliance Policy Guide

(CPG)615.115) for the extra-label use of medicated feed in minor species. Therefore, it is suggested that a new policy of regulatory discretion based on customer formulated feeds be incorporated into the MUMS indexing rule for the intended uses that fall below the proposed sales threshold. (Response) The lack of medicated feeds legally available to minor species is recognized by the agency. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) (Pub. L. 103-396) provides for certain extra-label uses of new animal drugs by veterinarians, but specifically prohibits extra-label use of medicated feeds. The CPG is intended to be a limited exercise of regulatory discretion regarding access to needed medicated feeds for some minor species. The indexing provision was included in the MUMS act partly to address this concern. It is intended to provide *legal* means for sponsors to provide these much-needed formulations to non-food minor species animals, like the zoo species cited in this comment. The agency recognizes that indexing will not provide for the legal availability of drugs for minor species under all circumstances. However, the exercise of regulatory discretion does not provide legal access under any circumstances. The administrative cost of indexing, as cited in the proposed rule, is an estimate of the average cost of indexing a new animal drug. The enormous variety of species and products will be reflected in the range of complexity of indexing these products. Variables such as the number of species to be included in the intended use, the availability of scientific literature and experts, whether or not the drug has already been approved in other species or formulations, etc. will have a significant effect on the cost of completing a request for indexing. Simple requests for indexing can be expected to require less time to prepare and, therefore, will be less costly than the estimate, while others may be more involved and will require more time. The agency will nonetheless continue to consider the exercise of regulatory discretion under appropriate circumstances and, as it gains experience with the indexing process, will consider whether it should make any changes to CPG 615.115. (Comment 12) One comment was received in regard to the proposed conforming changes to parts 201 and 202 (21 CFR parts 201 and 202). This comment stated that the addition of indexing references to these parts of 21 CFR will add very specific requirements to the labeling and advertising process for an unapproved drug. (Response) Part 201 pertains to drug labeling. The proposed conforming changes to part 201 are in subpart D which is entitled “Exemptions for Adequate Directions for Use.” The regulations in this subpart describe situations where new drug and new animal drug labeling would be exempt from the misbranding requirements of section 502(f)(1) of the act or provide clear descriptions of specific labeling information required to avoid misbranding under section 502(f)(1) of the act. Specifically, § 201.105 describes what information must appear on prescription new animal drug labeling and § 201.122 describes what information must appear on drugs for processing, packing, or manufacturing. The agency believes these same exemptions and clear descriptions should be available for index listed drugs and does not believe that the specific labeling requirements described in this subpart for approved new animal drugs are overly burdensome for index listed drugs. Furthermore, the labeling requirements for prescription new animal drugs described in § 201.105 are necessary for the safe and effective use of such drugs whether they are approved or index listed. Part 202 pertains to prescription drug advertising. The conforming change to § 202.1 will require that prescription drug advertising for index listed drugs shall not recommend or suggest any use that is not in the labeling accepted in such index listing and that the advertisement shall present information from labeling granted in the listing relating to each specific side effect and contraindication in such labeling that relates to the uses of the advertised drug dosage form(s). Section 202.1 currently contains this same provision for new animal drugs that are approved under section 512 of the act and for new drugs that are approved under section 505 of the act. We do not believe this conformation to current regulations is unreasonable. (Comment 13) One comment expressed confusion regarding whether unapproved index listed products that are drug listed under the provisions of part 207 (21 CFR part 207) are subject to product user fees under Animal Drug User Fee Act of 2003 (ADUFA). (Response) Unapproved new animal drugs that are index listed under section 572 of the act are not subject to product user fees under ADUFA (Pub. L. 108-130). Unless specifically exempted, all new animal drugs that are in commercial distribution, whether approved or not, are subject to the drug listing requirements of part 207 (see § 207.20). However, to be subject to a product user fee, an animal drug product must not only be subject to the drug listing requirements of part 207, but also approved as either an animal drug application or supplemental animal drug application (see section 740(a)(2) of the act). As defined under ADUFA, these applications do not include drugs that are index listed under section 572 of the act (see section 739(1) and

(2)of the act). (Comment 14) One comment asked for clarification on why certain conforming changes to the regulations in part 510 for approved drugs were proposed to apply to index listed drugs. (Response) Three sections in part 510 contain conforming changes. Those sections apply to new animal drugs, which means they apply to index listed drugs because they are new animal drugs. The conforming changes are needed so it is clear how these provisions apply in the context of index listed drugs. For example, § 510.301 describes the reporting and recordkeeping requirements for licensed medicated feed mills concerning experience with new animal drugs when used in or on animal feeds. Previously, the regulation said the records and report must be appropriately identified with the new animal drug application(s) to which they relate. The conforming amendment adds “or index listing(s)” to which they relate. Similarly, one of the items to be reported is any failure of the drug to meet specifications established for it in the new animal drug application. This is being amended to include specifications established in the request for determination of eligibility for indexing. Conforming amendments are also made in § 510.305, which requires licensed medicated feed mill operators to maintain approved labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated, and § 510.455, which describes the requirements for manufacturing a free-choice medicated animal feed. (Comment 15) One comment stated that due to the prohibitive cost of production of small quantities of separately labeled product, the requirement for labeling indexed drugs separately from approved drugs could be a deterrent for indexing useful drugs that are already approved in major species. The comment suggested that adequate distinction could be required on existing labeling to provide the indexed claims as well as information on the approved labeling. (Response) New animal drug labeling that contains information derived from both an application approved under section 512(b) of the act and from an index listing granted under section 572 of the act (572 index listing) would be misbranded under section 502(w)(2) of the act and would cause the new animal drug to be unsafe under section 512(a)(1)(A) and

(C)of the act. Simply put, in this situation, the labeling information derived from the 512(b) approval does not conform with the 572 index listing, and the labeling information derived from the 572 index listing does not conform with the 512(b) approval. For example, under section 572(h) of the act, the labeling of an index listed drug must include the statement “NOT APPROVED BY FDA.—Legally marketed as an FDA indexed product.” Such a statement would be false on the labeling of a product approved under section 512(b) of the act because that product has been approved by FDA. (Comment 16) One comment requested clarification on the statement in proposed § 516.155 to the effect that a product cannot be utilized in an extra-label manner once it is indexed. The comment said that this could be prohibitive to the veterinarian's ability to utilize an approved medication off label when needed if it has also been indexed. (Response) Under § 516.155, the label of an indexed drug must state that extra-label use is prohibited. This statement is based on section 572(h) of the act. However, this statement prohibiting extra-label use of new animal drugs indexed under section 572 of the act does not impose any restrictions, beyond those that already existed, on the extra-label use of new animal drugs approved under section 512(b) of the act. The extra-label use of an approved new animal drug is not permitted when “the labeling of another animal drug that contains the same active ingredient which is in the same dosage form and concentration” provides for the same use as a contemplated extra-label use (section 512(a)(4)(A) of the act). We believe that the reference to “another animal drug” in this provision means a new animal drug that, like the drug to be used in an extra-label manner, has been approved under section 512(b) of the act, and that it does not include a new animal drug that has been indexed under section 572 of the act. The regulations implementing the extra-label use provisions of section 512 of the act provide that one of the conditions for the extra-label use of an approved new animal drug is that “there is no *approved* new animal drug that is labeled for such use and that contains the same active ingredient which is in the required dosage form and concentration” (§§ 530.20(a)(1) (emphasis added) and 530.30(a)). Based on our interpretation of the act, we do not believe the condition in this regulation should be broadened to reference indexed drugs along with approved drugs. Thus, if a new animal drug is index listed for intended use A, for example, and the same active ingredient in the same dosage form is approved for intended use B, then the approved drug may be used in an extra-label manner for intended use A, as long as all other provisions of 21 CFR part 530 have been met. (Comment 17) One comment noted that the preamble failed to explicitly state that indexed drugs may fall into one of three categories: Over-the-counter, prescription, and veterinary feed directive (VFD). (Response) We agree that index listed drugs may fall into one of these three categories. Prescription status for index listed drugs is provided for in section 503(f)(1)(A)(ii) of the act and VFD status is provided for in section 504(a)(1) of the act. The current regulations in title 21 of the CFR have been revised accordingly by conforming change in this rulemaking at § 201.105, § 202.1, § 558.3, and § 558.6. (Comment 18) One comment stated that it appears that there can be a number of holders of the same product listed in the index, in other words, there is no exclusivity associated with index listing. (Response) We agree. There are no exclusive marketing rights associated with index listed drugs, such as are provided for MUMS-designated approved and conditionally approved drugs under section 573(c) of the act. (Comment 19) One comment requested clarification regarding whether proposed § 516.125(d) meant that target animal safety studies done under an index investigational new animal drug

(INAD)were not required to be conducted in accordance with good laboratory practices (GLPs). (Response) While the agency encourages adherence to GLPs to the maximum extent possible, the comment is correct that target animal safety studies in support of an index listing are not required to be conducted under GLPs. Qualified expert panels may consider all available information in reaching their conclusions regarding target animal safety and effectiveness, including target animal safety studies that do not meet the GLP standards of 21 CFR part 58. (Comment 20) One comment stated that the agency's estimated costs to a MUMS index drug requestor appeared to be reasonable and accurate. However, the comment also stated that, as a result of the fees referred to in § 516.141(g)(4), costs for complex reviews requiring extensive panel time may be dramatically higher than simple reviews that can be quickly completed. The comment suggested that, in an effort to contain such costs, avoid economic discrimination, and increase participation in the indexing process, the agency should consider, at least for an initial period of time, establishing a uniform fee of $10,000 for indexing requests. (Reponse) FDA anticipates that some expert panel members may charge requestors a fee for their professional services. § 516.141(g)(4) recognizes this fact and states that if such professional fees are paid they should be no more than commensurate with the value of the time that the member devotes to the review process in order to avoid a conflict of interest or the appearance of a conflict of interest. This cost to requestors is also discussed in the Analysis of Economic Impacts section of the proposed rule and this final rule. While the agency supports, in principle, efforts to contain costs and increase efficient utilization of the indexing process, the agency believes that, § 516.141(g)(4) notwithstanding, it should not be involved in establishing or otherwise regulating fees for the work expert panel members provide to the requestor as part of the indexing process. (Comment 21) One comment suggested that a requestor not necessarily be a particular firm, but potentially a group of individuals or organizations each of which could contribute to the indexing process. (Response) Under the new animal drug approval process, information gathered from multiple sources can be placed into master files from which the information can be referenced in support of one or more new animal drug applications. Master files can contain public or proprietary information relating to, for example, manufacturing processes. The indexing rule does not prevent different individuals or groups from contributing to the indexing of a drug product using this type of a master file mechanism, and FDA intends to allow for such master files to be used in the context of indexing. (Comment 22) One comment requested clarification of the post-indexing reporting requirements for chemistry, manufacturing, and control

(CMC)information and whether they will be the same as the Minor Changes and Stability Reporting

(MCSR)process. (Response) MCSR, as required by 21 CFR 514.8(b)(4), does not apply to indexed drugs. Under § 516.161(b)(1), changes in manufacturing methods or controls required to correct product or manufacturing defects that may result in serious adverse drug events should be made as soon as possible and a request to modify the indexed drug should be concurrently submitted to the Director, Office of Minor Use and Minor Species Animal Drug Development (OMUMS). Under § 516.165(c)(3)(iii), the annual indexed drug experience report must contain a summary of any changes made during the reporting period in the methods used in, and facilities and controls used for, manufacture, processing, and packing. This information must be presented in the same level of detail that it was presented in the request for determination of eligibility for indexing. The information is not included in this report, however, if it has already been submitted under § 516.161. (Comment 23) One comment stated that proposed § 516.165(a)(3) appeared to be inconsistent with proposed § 516.165(c)(3)(iii) in that § 516.165(a)(3) implied that indexed drugs must meet all “approved CMC requirements” while § 516.165(c)(3)(iii) implied that CMC information only needed to be reported in the level of detail it was originally described in the indexing request. (Response) The comment is correct that under § 516.165(c)(3)(iii), changes in the manufacturing process subsequent to product indexing need to be reported only to the level of detail that the manufacturing process was described in the original request for a determination of eligibility for indexing. However, section 572(d)(1)(F) of the act requires, as a condition of indexing, that requestors affirmatively commit to manufacture the drug product proposed for indexing according to current good manufacturing practices (cGMP). Accordingly, § 516.165(a)(3) reflects the requirement for the manufacturer of an indexed drug to meet the record-keeping requirements of the cGMP regulations, and that this requirement is *in addition* to annually reporting the relatively limited CMC information required by § 516.165. (Comment 24) One comment indicated that, with respect to occupational and user safety, the proposed regulations provided “no regulatory relief from the statutory requirement for an indexed drug.” (Response) This is an accurate observation. The regulations, §§ 516.129(c) and 516.133(a), are consistent with section 572(c)(1)(F) and (c)(2)(E) of the act in this regard. Both the regulations and the statutory provisions they implement require that this aspect of product safety be assessed in accordance with the requirements of section 512(d) of the act. (Comment 25) One comment stated that references to “statutory criteria” in the preamble were unclear, raising the question whether the qualified expert panel and the agency would be subject to the evidentiary standards of section 512 or to those of section 572. (Response) The comment failed to specifically identify where in the preamble the unclear references to statutory criteria appeared, but the agency presumes that it was in the introductory paragraph of section II. F. (71 FR 48840 at 48842 and 48843). This paragraph describes the two-part indexing review process established by the act, which includes a review of whether the new animal drug meets the statutory criteria regarding target animal safety and effectiveness. The standard for target animal safety and effectiveness is established, with respect to expert panels, under section 572(d)(2)(C) of the act and, with respect to the agency, under section 572(d)(4) as: The benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally approved new animal drug for the minor species in question. IV. Conforming Changes Conforming changes to certain applicable sections of title 21 of the Code of Federal Regulations

(CFR)can be found in: § 20.100 *Applicability; cross-reference to other regulations* . § 25.20 *Actions requiring preparation of an environmental assessment* . § 25.33 *Animal drugs* . § 201.105 *Veterinary drugs* . § 201.115 *New drugs or new animal drugs* . § 201.122 *Drugs for processing, repacking, or manufacturing* . § 202.1 *Prescription-drug advertisements* . § 207.21 *Times for registration and drug listing* . § 207.35 *Notification of registrant; drug establishment registration number and drug listing number* . § 225.1 *Current good manufacturing practice* . § 225.35 *Use of work areas, equipment, and storage areas for other manufacturing and storage purpose* . § 225.135 *Work and storage areas* . § 226.1 *Current good manufacturing practice* . § 500.25 *Anthelmintic drugs for use in animals* . § 500.26 *Timed-release dosage form drugs* . § 510.301 *Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect* . § 510.305 *Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs* . § 510.455 *Requirements for free-choice medicated feeds* . § 511.1 *New animal drugs for investigational use exempt from section 512(a) of the act* . § 515.10 *Medicated feed mill license applications* . § 515.21 *Refusal to approve a medicated feed mill license application* . § 558.3 *Definitions and general considerations applicable to this part* . § 558.5 *Requirements for liquid medicated feed* . § 558.6 *Veterinary feed directive drugs* . § 589.1000 *Gentian violet* . V. Legal Authority FDA's authority for issuing this final rule is provided by the MUMS act (21 U.S.C. 360ccc *et seq.* ). When Congress passed the MUMS act, it directed FDA to publish implementing regulations (see 21 U.S.C. 360ccc note). In the context of the MUMS act, the statutory requirements of section 572 of the act, along with section 701(a) of the act (21 U.S.C. 371(a)) provide authority for this final rule. Section 701(a) authorizes the agency to issue regulations for the efficient enforcement of the act. VI. Analysis of Economic Impacts FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; and distributive impacts and equity. The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA finds that the final rule does not constitute an economically significant regulatory action as defined in 3(f)(1) of Executive Order 12866. We base this on the following analysis that estimates annual costs ranging from about $476,000 in the first year to about $869,000 in the 10th year. Similarly, the administrative costs are unlikely to have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before establishing “any rule that may result in an annual expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $127 million, using the most current

(2006)implicit price deflator for the gross domestic product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. As such, no further analysis of anticipated costs and benefits is required by the Unfunded Mandates Reform Act. A. Summary The final rule is expected to result in about 30 requests for a determination of eligibility for indexing for 60 products annually, or 2 per requestor. We estimate that requestors for 20 of these products will create and convene expert panels to review the safety and efficacy data. Further, the recommendations of these panels are expected to lead to the addition of 20 animal drug index listings each year. B. Comments on Proposed Rule FDA received six comments to the proposed rule, none of which contained substantive comments on the methodology used in the analysis of impacts of the proposed rule. As such, we have retained the methodology for the analysis of the final rule. Our requests in the analysis of impacts section of the proposed rule for additional cost data did not elicit any data that conflicted with our estimates. We did, however, receive one comment that suggested the paperwork reporting burden may be too low. We revised the economic impacts associated with the paperwork reporting burden, as well as made other small changes to the final rule due to other public comments. We address comments on individual components and any changes made to the final rule in the administrative cost section. C. Benefit This rule intends to create administrative practices and procedures for index listing a new animal drug for use in a minor species, thereby providing the benefit of a legal basis for marketing an unapproved new animal drug intended for use in a minor species. The need for the rule arises from the existence of some minor species populations that are too small to support traditional drug approval studies. The countervailing risk of this rule is that animal drugs that are marginally economically viable could use this system to avoid the traditional animal drug approval process. Under this final rule, however, the voluntary indexing of a new animal drug for use in a minor species would only be allowed when the same drug in the same dosage form for the same intended use is not already approved or conditionally approved, thereby reducing this risk. D. Administrative Costs This section will describe and estimate the annual administrative costs by provision for both producers of currently unapproved drugs that would request an index listing and FDA. First, we address the efforts required by requestors concerned with index listing. The estimates of the number of requestors, frequencies of responses, and hours per procedure for each of the provisions of the final rule were determined by Center for Veterinary Medicine

(CVM)personnel for the proposed rule. Labor hour estimates for some procedure have been amended in this final rule due to public comments. We estimate that, on average, two foreign requestors of drug indexing would need to hire a permanent resident agent to represent them. We expect this to require about 1 hour of administrative time for a requestor's management employee in regulatory affairs. We estimate the loaded wage estimate at $42.29 per hour (including a 30 percent increase for benefits) for regulatory affairs personnel. 1 This provision would cost the two requestors a total of about $85. We expect that a resident agent would expend only about 6 hours of administrative effort per year per indexed drug. We estimate the wage rate of the resident agent at $100 to $150 per hour, and use the midpoint, $125, for our calculations. Total annual costs for resident agents are estimated at $1,500 (two agent times 6 hours times $125 per hour) in the first year. In the 10th year this is expected to rise to about $15,000 as two more resident agents each provide 6 more hours of administrative effort each additional year. 1 2004 National Industry-Specific Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics ( *www.bls.gov/oes/current/naics4_325400.htm* ); compliance officer wage rate for pharmaceutical and medicine manufacturing (NAICS 325400). Section 516.121 of the final rule provides for one or more meetings between requestors and FDA to discuss the requirements for indexing a new animal drug. We estimate that 30 requestors will each request, on average, 2 meetings annually, for a total of 60 meetings. Preparation and participation in these meetings is estimated at 4 hours each, for an annual total of 240 hours. Section 516.123 concerns informal conferences regarding agency administrative actions. These would include conferences to discuss a request for determination of eligibility that has been denied, the removal of an expert panel member, a request for indexing that was denied or an indexed drug that was removed from the list. In response to public comments, we have provided for a 60-day time period for industry to respond with a written request for a conference, rather than the proposed 30-day time period. Additionally, we have amended the final rule to require that an informal conference be scheduled and held within a 45-day period from our receipt of a request for an informal conference. The proposed rule would have required that we only attempt to schedule and hold the conference within 30 days. We do not expect these two changes to have an impact on the cost estimates of this provision. We estimate that about three requestors would request one conference with us annually for any of these reasons. We expect that each requestor would expend about 8 hours (24 hours total) to prepare for and attend each of these conferences. The combined efforts for preparation and participation in all conferences (§ 516.123) are estimated at 264 hours (240 plus 24). At the same loaded wage estimate of $42.29 per hour, this provision is expected to cost about $11,200 annually. For section 516.125, we estimate that two requestors would each annually submit three notices of claimed investigational exemptions for new animal drugs for index listing. We estimate that each submission would require about 20 hours for regulatory affairs personnel to prepare. At the loaded wage estimate of $42.29 per hour, the total of 120 hours would cost about $5,100. We estimate that about 30 requestors would each average about 2 requests for determination of eligibility for indexing of individual animal drugs annually, totaling to 60 requests annually for proposed § 516.129. Based on a public comment that the paperwork burden was underestimated in the proposed rule, we have increased the number of labor hours for preparing each request from 12 to 20. At the loaded wage estimate of $42.29 per hour, this provision would require about 1,200 hours equal to about $50,700. Included in this estimate of 60 requests are any resubmitted requests that were previously denied. Section 516.141 requires the creation of a qualified expert panel to review all information, provided by any source, relevant to a determination of the target animal safety and effectiveness of the new animal drug. We are required to approve the panel members before the panel formally convened. We estimate that requestors of 20 animal drugs, or about one-third of the 60 animal drugs that annually are determined to be eligible for indexing, would create qualified expert panels to further study the safety and efficacy data. The creation of each panel by a requestor is estimated to take about 16 hours of effort by regulatory affairs personnel. This figure has been increased from the 8 hours estimated in the proposed rule based on a public comment. At the same loaded wage estimate, these 320 hours are estimated at about $13,500 annually. An additional 0.5 hours is estimated for recordkeeping for the creation of the qualified panels described in § 516.141. This would result in an additional $400 in annual costs. Section 516.143 describes how the expert panel will prepare a written report for FDA with its findings concerning the new animal drug under consideration for index listing. The review of the relevant information and preparation of the report by each panel would take an estimated 120 hours, an increase from the 80 hours estimated for the proposed rule. This equates to 2,400 hours for 20 panels. The rule allows for fees to be paid to panel members for their time. We estimate the average wage rate for panel members at $100 to $150/hr, and use the midpoint ($125) in our calculations. At this wage, we estimate these activities to cost up to $300,000 annually for the total industry, or $15,000 per requestor for each animal drug under consideration. We estimate that the formal request for addition to the index, provided for in § 516.145, will require about 20 hours to prepare, an increase from the 12 hours estimated in the proposed rule. This will result in another 400 hours of effort (20 requests times 20 hours) for regulatory affairs personnel. We project the compliance cost of this effort at $16,900 annually. We only expect to receive one request each for a modification to an indexed listed drug and a change in ownership of an index file annually (provided for in proposed §§ 516.161 and 516.163), and estimate the preparation of each to require 4 and 2 hours, respectively. In total, these compliance efforts will cost about $250 in the first year. Total modification requests and ownership change notifications are expected to increase by one each year so that 10 of each would be expected to be submitted in year 10. The cost of these provisions in year 10 is estimated at about $2,500. This final rule will require, in § 516.165, that records and reports be created, submitted and retained by the holder of the indexed drug. These records include a 3-day indexed drug field alert report, a 15-day indexed drug field alert report and an annual indexed drug experience report. We expect that the vast majority of compliance efforts will be associated with the annual indexed drug experience report. Because the number of expected requests that are granted for addition to the index is 20 per year (on average, 20 requestors with 1 request granted each), the number of reports to be created, submitted and stored is also estimated at 20 per year. We estimate the reports for each index listing will require 8 hours annually, totally about 160 hours for all 20 listings. At the loaded wage estimate of $42.29 per hour, we estimate the first-year reporting costs at about $6,800. These annual costs will increase by an additional $6,800 each year as an additional 20 indexed drugs are added to the list. In year 10 we estimate the cost of this provision at about $67,700. Further, we expect that the maintenance of these records (recordkeeping) will require an additional hour of administrative time for each indexed drug listing. These additional 20 hours will cost about $850 at the same loaded wage estimate in the first year, and would also increase in succeeding years by an additional $850 as additional indexed drugs are added to the list. We estimate the cost of this provision in year 10 at about $8,500. For those choosing to seek a MUMS index listing of an unapproved animal drug, total requestor compliance costs are expected to sum to about $407,000 in the first year. This represents an increase of $134,000 from the $273,000 estimated cost of the proposed rule. These costs will be borne by 30 firms that make a request for determination of eligibility for indexing at an average cost per requestor of about $13,600 per submission. Including only those estimated 20 firms that followup with a request for addition to the index, we project average costs at about $19,000. Costs in succeeding years would be expected to increase slightly due to the annual reporting requirements for all indexed drugs, resulting in year-10 total costs for the industry at about $492,000. E. Costs to Government The Government would also incur costs for this final rule. We expect that about 60 percent of a full-time equivalent employee at a GS-14 salary would be needed to handle the administrative work of the indexing of MUMS drugs in the first year. This would include all administrative efforts from responding to requests for presubmission meetings to making changes to approved indexed drugs. We estimate Government costs (including a 30 percent adjustment for benefits) of this provision at about $69,000 in the first year. In year 10 we estimate that up to four full time equivalent employees (one GS-14 position, two GS-13 positions and one GS-11 position) would be needed to administer the program. Including a 30 percent adjustment for benefits, we estimate that the cost to Government in year 10 could increase to about $378,000. Total costs for this final rule would be the sum of private administrative and Government costs. Total costs are estimated to increase from $476,000 in the first year up to $869,000 in the 10th year. F. Regulatory Flexibility Analysis 1. Small Business Impacts The Regulatory Flexibility Act requires agencies to prepare a regulatory flexibility analysis if a rule is expected to have a significant economic impact on a substantial number of small entities. Although we believe it is unlikely that significant economic impacts would occur, the following constitutes the final regulatory flexibility analysis. One requirement of the Regulatory Flexibility Act is a succinct statement of any objectives of the rule. As stated previously in this analysis, with this rule the agency intends to create an administrative system, provided for by statute, that would allow for the legal marketing of unapproved animal drugs for use in minor species in the U.S. that would otherwise not be economically viable under current market conditions. The Regulatory Flexibility Act also requires a description of the small entities that would be affected by the rule, and an estimate of the number of small entities to which the rule would apply. The Small Business Administration

(SBA)defines the criteria for small businesses using the North American Industrial Classification System (NAICS). For pharmaceutical preparation manufacturers (NAICS number 325412), SBA defines small businesses as those with fewer than 750 employees. Census data shows that 723 companies with 901 establishments represent this category. 2 While about two-thirds of the establishments would be considered small using the SBA criteria, the agency acknowledges that many requests for MUMS index listing would likely be received from multi-establishment companies that exceed the 750-employee limit on small businesses. Nonetheless, the average cost for a requestor that has two meetings with us, requests a determination of eligibility for indexing, creates and convenes a qualified panel of experts resulting in a written report, requests an addition to the index and keeps all necessary records, would be about $19,000. This cost per request represents about 2.1 percent of the revenues of the smallest set of establishments (those establishments with 1 to 4 employees), and 0.5 percent or less of revenues of all larger establishments. 3 These costs would not represent a significant economic impact on the firms expected to request an index listing, especially in light of the fact that they incur these expenses in order to realize increased sales revenue from the indexing. The firms submitting requests for index listing are expected to already have the necessary administrative personnel with the skills required to prepare the requests and fulfill reporting requirements as identified above. 2 2002 Economic Census, U.S. Census Bureau, Manufacturing Industry Series, Pharmaceutical Preparation Manufacturing, tables 3 and 4. 3 U.S. Department of Labor, Bureau of Labor Statistics. 2002 revenues inflated to 2007 dollars using the CPI-U. 2. Analysis of Alternatives The Regulatory Flexibility Act requires that the agency consider any alternatives to the final rule that would accomplish the objective while minimizing significant impacts of the rule. As stated previously, the agency believes that the final rule, due to the relatively small size of the costs, would not be likely to impose significant economic impacts on a substantial number of small entities. The statute that creates this system, Public Law 108-282, does not provide the agency a great deal of flexibility in the implementing regulations, such as in determining whether or not to use independent qualified expert panels to review the safety and efficacy data. We conclude that the final rule achieves the objective of increasing the number of drugs that can be legally marketed for minor species with minimal costs to industry while staying within the limits set by Public Law 108-282. VII. Paperwork Reduction Act of 1995 This final rule contains information collection provisions that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given below with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. *Title* : Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 21 CFR part 516. *Description* : The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats), as well as uncommon diseases in major animal species. The MUMS act created three new sections to the act (section 571, 572, and 573), and this final rule implements section 572 of the act, which provides for an index of legally marketed unapproved new animal drugs for minor species. Participation in any part of the MUMS program is optional so the associated paperwork only applies to those who choose to participate. The final rule specifies, among other things, the criteria and procedures for requesting eligibility for indexing and for requesting addition to the index as well as the annual reporting requirements for index holders. Under the new subpart C of part 516 (21 CFR part 516), § 516.119 provides requirements for naming a permanent-resident U.S. agent by foreign drug companies, and § 516.121 provides for informational meetings with FDA. Section 516.123 provides requirements for requesting informal conferences regarding agency administrative actions and § 516.125 provides for investigational use of new animal drugs intended for indexing. Provisions for requesting a determination of eligibility for indexing can be found under § 516.129 and provisions for subsequent requests for addition to the index can be found under § 516.145. A description of the written report required in § 516.145 can be found under § 516.143. Under § 516.141 are provisions for drug companies to nominate a qualified expert panel as well as the panel's recordkeeping requirements. This section also calls for the submission of a written conflict of interest statement to FDA by each proposed panel member. Index holders are able to modify their index listing under § 516.161 or change drug ownership under § 516.163. Requirements for records and reports are under § 516.165. *Description of Respondents* : Pharmaceutical companies that sponsor new animal drugs. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 516.119 2 1 2 1 2 516.121 30 2 60 4 240 516.123 3 1 3 8 24 516.125 2 3 6 20 120 516.129 30 2 60 20 1,200 516.141 20 1 20 16 320 516.143 20 1 20 120 2,400 516.145 20 1 20 20 400 516.161 1 1 1 4 4 516.163 1 1 1 2 2 516.165 10 2 20 8 160 Total 4,872 1 There is no capital or operating and maintenance cost associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 516.141 30 2 60 0.5 30 516.165 10 2 20 1 20 Total 50 1 There is no capital or operating and maintenance cost associated with this collection of information. FDA announced that the proposed rule contained information collection provisions that were subject to review by OMB under the Paperwork Reduction Act of 1995 and invited public comment in the **Federal Register** of August 22, 2006 (71 FR 48840). In response to that notice FDA received two comments concerning the estimated paperwork reporting burden. One comment said that the estimates appear to be reasonable and accurate while the other comment said that some were potentially underestimated. Specifically, the second comment felt that the agency's estimates for the hours per response were too low for the time required for creation of an expert panel by regulatory professionals in § 516.141 and for the time required to prepare the written report in § 516.143. Although the comment did not offer new estimates for these sections, FDA agrees that these estimates may be too low. Therefore, FDA believes that 16 hours is a more reasonable response time required for creation of an expert panel. In view of increased reporting requirements under § 516.141, CVM has increased the “Hours per Response” under this citation in “Table 1. Estimated Annual Reporting Burden,” from 8 to 16 hours thereby increasing the total burden hours to 320. FDA also believes that 120 hours is a more reasonable response time required to prepare the written report. In view of increased reporting requirements under § 516.143, CVM has increased the “Hours per Response” under this citation in “Table 1. Estimated Annual Reporting Burden,” from 80 to 120 hours thereby increasing the total burden hours to 2400. The second comment also proposed 20 to 80 hours of response time for preparation of a request for determination of eligibility and 20 to 80 hours of response time for preparation of a request for addition to the index. FDA agrees, in light of both comments, that 20 hours is a more reasonable response time required to prepare each of these two submissions. In view of increased reporting requirements under § 516.129, CVM has increased the “Hours per Response” under this citation in “Table 1. Estimated Annual Reporting Burden,” from 12 to 20 hours thereby increasing the total burden hours to 1,200. For § 516.145, CVM has also increased the “Hours per Response” in “Table 1. Estimated Annual Reporting Burden,” from 12 to 20 hours thereby increasing the total burden hours for this section to 400. The second comment also requested clarification on the time allotted for the notice of claimed investigational exemption in § 516.125. This reporting burden accounts for the time required to prepare information pertinent to the safety or effectiveness of a drug derived from investigational studies for review by the expert panel. Finally, it should be noted that FDA received no comment on the proposed conforming changes to 21 CFR 515.10(b) which describes what information must be contained in a medicated feed mill license application. Accordingly, the agency is revising Form FDA 3448 Medicated Feed Mill License Application (OMB No. 0910-0337) to reflect these minor conforming changes. This revision will not change the information reporting burden already approved for this form. It merely revises one of the certifications to reflect the fact that new animal drugs now include index listed drugs. The information collection provisions of this final rule have been submitted to OMB for review. Prior to the effective date of this final rule, FDA will publish a notice in the **Federal Register** announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. VIII. Environmental Impact We have carefully considered the potential environmental impacts of this final rule and determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment, nor an environmental impact statement is required. IX. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. List of Subjects 21 CFR Part 20 Confidential business information, Courts, Freedom of information, Government employees. 21 CFR Part 25 Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements. 21 CFR Part 201 Drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 202 Advertising, Prescription drugs. 21 CFR Part 207 Drugs, Reporting and recordkeeping requirements. 21 CFR Part 225 Animal drugs, Animal feeds, Labeling, Packaging and containers, Reporting and recordkeeping requirements. 21 CFR Part 226 Animal drugs, Animal feeds, Labeling, Packaging and containers, Reporting and recordkeeping requirements. 21 CFR Part 500 Animal drugs, Animal feeds, Cancer, Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs). 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 511 Animal drugs, Medical research, Reporting and recordkeeping requirements. 21 CFR Part 515 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Part 558 Animal drugs, Animal feeds. 21 CFR Part 589 Animal feeds, Animal foods, Food additives. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR Chapter I is amended as follows: PART 20—PUBLIC INFORMATION 1. The authority citation for 21 CFR part 20 continues to read as follows: Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1. 2. Amend § 20.100 by adding paragraph (c)(44) to read as follows: § 20.100 Applicability; cross-reference to other regulations.

(c)* * *

(44)Minor-species drug index listings, in § 516.171 of this chapter. PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS 3. The authority citation for 21 CFR part 25 continues to read as follows: Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360. 4. Amend § 25.20 by revising paragraph

(m)to read as follows: § 25.20 Actions requiring preparation of an environmental assessment.

(m)Approval of NADA's, abbreviated applications, supplements, actions on INAD's, and granting of requests for determination of eligibility for indexing, unless categorically excluded under § 25.33 (a), (c), (d), or (e). 5. Amend § 25.33 by revising paragraphs

(a)introductory text, (c),

(d)introductory text, and

(g)to read as follows: § 25.33 Animal drugs.

(a)Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supplement to such applications, or a modification of an index listing, if the action does not increase the use of the drug. Actions to which this categorical exclusion applies may include:

(c)Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supplement to such applications, or a modification of an index listing, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.

(d)Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supplement to such applications, or a modification of an index listing, for:

(g)Withdrawal of approval of an NADA or an abbreviated NADA or removal of a new animal drug from the index. PART 201—LABELING 6. The authority citation for 21 CFR part 201 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264. 7. Amend § 201.105 by revising paragraphs (c)(2) and (d)(1) to read as follows: § 201.105 Veterinary drugs.

(c)* * *

(2)If the article is subject to section 512 or 572 of the act, the labeling bearing such information is the labeling authorized by the approved new animal drug application or contained in the index listing: *Provided, however* , That the information required by paragraph (c)(1) of this section may be omitted from the dispensing package if, but only if, the article is a drug for which directions, hazards, warnings, and use information are commonly known to veterinarians licensed by law to administer the drug. Upon written request, stating reasonable grounds therefore, the Commissioner will offer an opinion on a proposal to omit such information from the dispensing package under this proviso.

(d)* * *

(1)Adequate information for such use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant warnings, hazards, contraindications, side effects, and precautions, and including information relevant to compliance with the new animal drug provisions of the act, under which veterinarians licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all conditions for which it is advertised or represented; and if the article is subject to section 512 or 572 of the act, the parts of the labeling providing such information are the same in language and emphasis as labeling approved, permitted, or indexed under the provisions of section 512 or 572, and any other parts of the labeling are consistent with and not contrary to such approved, permitted, or indexed labeling; and 8. Amend § 201.115 by revising paragraphs

(a)and

(b)to read as follows: § 201.115 New drugs or new animal drugs.

(a)To the extent to which such exemption is claimed in an approved application with respect to such drug under section 505 or 512 of the act or an index listing with respect to such drug under section 572 of the act; or

(b)If no application under section 505 or 512 of the act is approved and no request for addition to the index is granted under section 572 with respect to such drug but it complies with section 505(i), 512(j), or 572(g) of the act and regulations thereunder. 9. Amend § 201.122 by revising paragraphs (a), (b), and

(c)to read as follows: § 201.122 Drugs for processing, repacking, or manufacturing.

(a)An approved new drug application or new animal drug application or a new animal drug index listing covers the production and delivery of the drug substance to the application or index listing holder by persons named in the application or in the request for determination of eligibility for indexing, and, for a new drug substance, the export of it by such persons under § 314.410 of this chapter; or

(b)If no application is approved with respect to such new drug or new animal drug, and it is not listed in the index, the label statement “Caution: For manufacturing, processing, or repacking” is immediately supplemented by the words “in the preparation of a new drug or new animal drug limited by Federal law to investigational use”, and the delivery is made for use only in the manufacture of such new drug or new animal drug limited to investigational use as provided in part 312 or § 511.1 or § 516.125 of this chapter; or

(c)A new drug application or new animal drug application or a request for addition to the index covering the use of the drug substance in the production and marketing of a finished drug product has been submitted but not yet approved, disapproved, granted, or denied, the bulk drug is not exported, and the finished drug product is not further distributed after it is manufactured until after the new drug application or new animal drug application is approved or the request for addition to the index is granted. PART 202—PRESCRIPTION DRUG ADVERTISING 10. The authority citation for 21 CFR part 202 continues to read as follows: Authority: 21 U.S.C. 321, 331, 352, 355, 360b, 371. 11. Amend § 202.1 by revising paragraph (e)(4)(i) *(a)* to read as follows: § 202.1 Prescription-drug advertisements.

(e)* * *

(4)*Substance of information to be included in brief summary* . (i)( *a* ) An advertisement for a prescription drug covered by a new-drug application approved pursuant to section 505 of the act after October 10, 1962, or a prescription drug covered by a new animal drug application approved pursuant to section 512 of the act after August 1, 1969, or any approved supplement thereto, or for a prescription drug listed in the index pursuant to section 572 of the act, or any granted modification thereto, shall not recommend or suggest any use that is not in the labeling accepted in such approved new-drug application or supplement, new animal drug application or supplement, or new animal drug index listing or modification. The advertisement shall present information from labeling required, approved, permitted, or granted in a new-drug or new animal drug application or new animal drug index listing relating to each specific side effect and contraindication in such labeling that relates to the uses of the advertised drug dosage form(s) or shall otherwise conform to the provisions of paragraph (e)(3)(iii) of this section. PART 207—REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION 12. The authority citation for 21 CFR part 207 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271. 13. Amend § 207.20 by revising paragraph

(c)to read as follows: § 207.20 Who must register and submit a drug list.

(c)Before beginning manufacture or processing of a drug subject to one of the following applications, an owner or operator of an establishment is required to register before the agency approves or grants it: A new drug application, an abbreviated new drug application, a new animal drug application, an abbreviated new animal drug application, a medicated feed mill license application, a biologics license application, or a request for addition to the index. 14. Amend § 207.21 by revising the second sentence in paragraph

(a)to read as follows: § 207.21 Times for registration and drug listing.

(a)* * * If the owner or operator of the establishment has not previously entered into such an operation, the owner or operator shall register within 5 days after submitting a new drug application, abbreviated new drug application, new animal drug application, abbreviated new animal drug application, request for addition to the index, medicated feed mill license application, or a biologics license application. * * * 15. Amend § 207.35 by revising paragraph (b)(3)(v) to read as follows: § 207.35 Notification of registrant; drug establishment registration number and drug listing number.

(b)* * *

(3)* * *

(v)The placing of the assigned NDC number on a label or in other labeling does not require the submission of a supplemental new drug application, supplemental new animal drug application, or a modification to an index listing. PART 225—CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 16. The authority citation for 21 CFR part 225 continues to read as follows: Authority: 21 U.S.C. 351, 352, 360b, 371, 374. 17. Amend § 225.1 by revising paragraph

(c)to read as follows: § 225.1 Current good manufacturing practice.

(c)In addition to the recordkeeping requirements in this part, Type B and Type C medicated feeds made from Type A articles or Type B feeds under approved NADAs or indexed listings and a medicated feed mill license are subject to the requirements of § 510.301 of this chapter. 18. Amend § 225.35 by revising paragraph

(b)to read as follows: § 225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

(b)Work areas and equipment used for the manufacture or storage of medicated feeds or components thereof shall not be used for, and shall be physically separated from, work areas and equipment used for the manufacture of fertilizers, herbicides, insecticides, fungicides, rodenticides, and other pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for use in the manufacture of medicated feed. 19. Revise § 225.135 to read as follows: § 225.135 Work and storage areas. Work areas and equipment used for the production or storage of medicated feeds or components thereof shall not be used for, and shall be physically separated from, work areas and equipment used for the manufacture and storage of fertilizers, herbicides, insecticides, fungicides, rodenticides, and other pesticides unless such articles are approved or index listed for use in the manufacture of animal feed. PART 226—CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 20. The authority citation for 21 CFR part 226 continues to read as follows: Authority: 21 U.S.C. 351, 352, 360b, 371, 374. 21. Amend § 226.1 by adding a second sentence to paragraph

(b)to read as follows: § 226.1 Current good manufacturing practice.

(b)* * * Similarly, Type A medicated articles listed in the index are subject to the requirements of § 516.165 of this chapter. PART 500—GENERAL 22. The authority citation for 21 CFR part 500 continues to read as follows: Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371. 23. Amend § 500.25 by revising paragraph

(c)to read as follows: § 500.25 Anthelmintic drugs for use in animals.

(c)For drugs covered by approved new animal drug applications, the labeling revisions required for compliance with this section may be placed into effect without prior approval, as provided for in § 514.8(c)(3) of this chapter. For drugs listed in the index, the labeling revisions required for compliance with this section may be placed into effect without prior granting of a request for a modification, as provided for in § 516.161(b)(1) of this chapter. 24. Amend § 500.26 by revising paragraph

(b)and the second sentence in paragraph

(c)to read as follows: § 500.26 Timed-release dosage form drugs.

(b)Timed-release dosage form animal drugs that are introduced into interstate commerce are deemed to be adulterated within the meaning of section 501(a)(5) of the act and subject to regulatory action, unless such animal drug is the subject of an approved new animal drug application, or listed in the index, as required by paragraph

(a)of this section.

(c)* * * A new animal drug application or index listing is required in any such case. PART 510—NEW ANIMAL DRUGS 25. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 26. Amend § 510.301 by revising the introductory text, paragraph (a)(2), and the second sentence in paragraph (b)(1) to read as follows: § 510.301 Records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect. Records and reports of clinical and other experience with the new animal drug will be maintained and reported, appropriately identified with the new animal drug application(s) or index listing(s) to which they relate, to the Center for Veterinary Medicine in duplicate in accordance with the following:

(a)* * *

(2)Information concerning any bacteriological or any significant chemical, physical, or other change or deterioration in the drug, or any failure of one or more distributed batches of the drug to meet the specifications established for it in the new animal drug application or request for determination of eligibility for indexing.

(b)* * *

(1)* * * *Unexpected* as used in this paragraph refers to conditions or developments not previously submitted as part of the new animal drug application or in support of the index listing or not encountered during clinical trials of the drug, or conditions or developments occurring at a rate higher than shown by information previously submitted as part of the new animal drug application or in support of the index listing or at a rate higher than encountered during such clinical trials. 27. Amend § 510.305 by revising paragraph

(b)to read as follows: § 510.305 Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new animal drugs.

(b)Approved or index listed labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated. 28. Amend § 510.455 by revising paragraphs

(b)and

(c)to read as follows: § 510.455 Requirements for free-choice medicated feeds.

(b)*What is required for new animal drugs intended for use in free-choice feed* ? Any new animal drug intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)) or listed in the index under section 572 of the act (21 U.S.C. 360ccc-1). Such approvals under section 512 of the act must be:

(1)An original new animal drug application (NADA),

(2)A supplemental NADA, or

(3)An abbreviated NADA.

(c)*What are the approval requirements under section 512 of the act for new animal drugs intended for use in free-choice feed* ? An approval under section 512 of the act for a Type A medicated article intended for use in free-choice feed must contain the following information:

(1)Data, or reference to data in a master file (MF), showing that the target animal consumes the new animal drug in the Type C free-choice feed in an amount that is safe and effective (consumption/effectiveness data); and

(2)Data, or reference to data in an MF, showing the relevant ranges of conditions under which the drug will be chemically and physically stable in the Type C free-choice feed under field conditions. PART 511—NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE 29. The authority citation for 21 CFR part 511 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 353, 360b, 371. 30. Amend § 511.1 by adding paragraph

(g)to read as follows: § 511.1 New animal drugs for investigational use exempt from section 512(a) of the act.

(g)*Index of legally marketed unapproved new animal drugs for minor species* . All provisions of part 511 apply to new animal drugs for investigational use in support of indexing, as described in section 572 of the act, subject to the provisions of § 516.125 of this chapter. PART 515—MEDICATED FEED MILL LICENSE 31. The authority citation for 21 CFR part 515 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 32. Amend § 515.10 by revising paragraphs (b)(4) and (b)(7) to read as follows: § 515.10 Medicated feed mill license applications.

(b)* * *

(4)A certification that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations published under section 512(i) of the act or in accordance with the index listing published under section 572(e)(2) of the act.

(7)A commitment that current approved or index listed Type B and/or Type C medicated feed labeling for each Type B and/or Type C medicated feed to be manufactured will be in the possession of the feed manufacturing facility prior to receiving the Type A medicated article containing such drug. 33. Amend § 515.21 by revising paragraph (a)(3) to read as follows: § 515.21 Refusal to approve a medicated feed mill license application.

(a)* * *

(3)The facility manufactures animal feeds bearing or containing new animal drugs in a manner that does not accord with the specifications for manufacture or labels animal feeds bearing or containing new animal drugs in a manner that does not accord with the conditions or indications of use that are published under section 512(i) or 572(e)(2) of the act. PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 34. The authority citation for part 516 is revised to read as follows: Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371. 35. Part 516 is amended by adding subpart C, consisting of §§ 516.111 to 516.171, to read as follows: Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species Sec. 516.111 Scope of this subpart. 516.115 Definitions. 516.117 Submission of correspondence under this subpart. 516.119 Permanent-resident U.S. agent for foreign requestors and holders. 516.121 Meetings. 516.123 Informal conferences regarding agency administrative actions. 516.125 Investigational use of minor species new animal drugs to support indexing. 516.129 Content and format of a request for determination of eligibility for indexing. 516.131 Refuse to file a request for determination of eligibility for indexing. 516.133 Denying a request for determination of eligibility for indexing. 516.135 Granting a request for determination of eligibility for indexing. 516.137 Notification of decision regarding eligibility for indexing. 516.141 Qualified expert panels. 516.143 Written report. 516.145 Content and format of a request for addition to the index. 516.147 Refuse to file a request for addition to the index. 516.149 Denying a request for addition to the index. 516.151 Granting a request for addition to the index. 516.153 Notification of decision regarding index listing. 516.155 Labeling of indexed drugs. 516.157 Publication of the index and content of an index listing. 516.161 Modifications to indexed drugs. 516.163 Change in ownership of an index file. 516.165 Records and reports. 516.167 Removal from the index. 516.171 Confidentiality of data and information in an index file. Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species § 516.111 Scope of this subpart. This subpart implements section 572 of the act and provides standards and procedures to establish an index of legally marketed unapproved new animal drugs. This subpart applies only to minor species and not to minor use in major species. This index is only available for new animal drugs intended for use in a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals and for new animal drugs intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, nonfood life stage of a food-producing minor species, where safety for humans is demonstrated in accordance with the standard of section 512(d) of the act (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance). The index shall not include a new animal drug that is contained in, or a product of, a transgenic animal. Among its topics, this subpart sets forth the standards and procedures for:

(a)Investigational exemptions for indexing purposes;

(b)Submissions to FDA of requests for determination of eligibility of a new animal drug for indexing;

(c)Establishment and operation of expert panels;

(d)Submissions to FDA of requests for addition of a new animal drug to the index;

(e)Modifications to index listings;

(f)Publication of the index; and

(g)Records and reports. § 516.115 Definitions.

(a)The following definitions of terms apply only in the context of subpart C of this part: *Director OMUMS* means the Director of the Office of Minor Use and Minor Species Animal Drug Development of the FDA Center for Veterinary Medicine. *Holder* means the requestor of an index listing after the request is granted and the new animal drug is added to the index. *Index* means FDA's list of legally marketed unapproved new animal drugs for minor species. *Intended use* has the same meaning as that given in § 516.13 of this chapter. *Qualified expert panel* means a panel that is composed of experts qualified by scientific training and experience to evaluate the target animal safety and effectiveness of a new animal drug under consideration for indexing. *Requestor* means the person making a request for determination of eligibility for indexing or a request for addition to the index. *Transgenic animal* means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal, provided that the term ‘transgenic animal’ does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding.

(b)The definitions of the following terms are given in § 514.3 of this chapter: Adverse drug experience. Product defect/manufacturing defect. Serious adverse drug experience. Unexpected adverse drug experience.

(c)The definitions of the following terms are given in § 516.3 of this chapter: Same dosage form. Same drug. Same intended use. § 516.117 Submission of correspondence under this subpart. Unless directed otherwise by FDA, all correspondence relating to any aspect of the new animal drug indexing process described in this subpart must be addressed to the Director, OMUMS. The initial correspondence for a particular index listing should include the name and address of the authorized contact person. Notifications of changes in such person or changes of address of such person should be provided in a timely manner. § 516.119 Permanent-resident U.S. agent for foreign requestors and holders. Every foreign requestor and holder shall name a permanent resident of the United States as their agent upon whom service of all processes, notices, orders, decisions, requirements, and other communications may be made on behalf of the requestor or holder. Notifications of changes in such agents or changes of address of agents should preferably be provided in advance, but not later than 60 days after the effective date of such changes. The permanent resident U.S. agent may be an individual, firm, or domestic corporation and may represent any number of requestors or holders. The name and address of the permanent-resident U.S. agent shall be submitted to the Director, OMUMS, and included in the index file. § 516.121 Meetings.

(a)A requestor or potential requestor is entitled to one or more meetings to discuss the requirements for indexing a new animal drug.

(b)Requests for such meetings should be in writing, be addressed to the Director, OMUMS, specify the participants attending on behalf of the requestor or potential requestor, and contain a proposed agenda for the meeting.

(c)Within 30 days of receiving a request for a meeting, FDA will attempt to schedule the meeting at a time agreeable to both FDA and the person making the request. § 516.123 Informal conferences regarding agency administrative actions.

(a)Should FDA make an initial decision denying a request for determination of eligibility for indexing, terminating an investigational exemption, determining that a qualified expert panel does not meet the selection criteria, denying a request for addition to the index, or removing a new animal drug from the index, FDA will give written notice that specifies the grounds for the initial decision and provides an opportunity for an informal conference for review of the decision.

(b)The written notice will include information for scheduling the informal conference and state that a written request for a conference must be made within 60 days of the date FDA sends its notice.

(c)Within 45 days of receiving a request for an informal conference, FDA will schedule and hold the informal conference at a time agreeable to both FDA and the person making the request.

(d)Such an informal conference will be conducted by a presiding officer who will be the Director of the Center for Veterinary Medicine or his or her designee, excluding the Director of the Office of Minor Use and Minor Species Animal Drug Development and other persons significantly involved in the initial decision.

(e)The person requesting an informal conference must provide a written response to FDA's initial decision at least 2 weeks prior to the date of the scheduled meeting. Generally, this written response would be attached to the request for an informal conference. At the option of the person requesting an informal conference, such written response to FDA's initial decision may act in lieu of a face-to-face meeting. In this case, the informal conference will consist of a review by the presiding officer of the submitted written response.

(f)The purpose of an informal conference is to discuss scientific and factual issues. It will involve a discussion of FDA's initial decision and any written response to that decision.

(g)Internal agency review of a decision must be based on the information in the administrative file. If the person requesting an informal conference presents new information not in the file, the matter will be returned to the appropriate lower level in the agency for reevaluation based on the new information.

(h)Informal conferences under this part are not subject to the separation of functions rules in § 10.55 of this chapter.

(i)The rules of evidence do not apply to informal conferences. No motions or objections relating to the admissibility of information and views will be made or considered, but any party to the conference may comment upon or rebut all such data, information and views.

(j)[Reserved]

(k)The presiding officer will prepare a written report regarding the subject of the informal conference that states and describes the basis for his or her findings. Whenever time permits, the parties to the informal conference will have 30 days to review and comment on the report.

(l)The administrative record of the informal conference will consist of:

(1)The notice providing an opportunity for an informal conference and the written response to the notice.

(2)All written information and views submitted to the presiding officer at the conference or, at the discretion of the presiding officer, thereafter.

(3)The presiding officer's written report.

(4)All correspondence and memoranda of any and all meetings between the participants and the presiding officer.

(m)The administrative record of the informal conference is closed to the submission of information at the close of the conference, unless the presiding officer specifically permits additional time for further submission.

(n)The administrative record of the informal conference specified herein constitutes the exclusive record for decision. § 516.125 Investigational use of minor species new animal drugs to support indexing.

(a)The investigational use of a new animal drug or animal feed bearing or containing a new animal drug intended solely for investigational use in minor species shall meet the requirements of part 511 of this chapter if the investigational use is for the purpose of:

(1)Demonstrating human food safety under section 572(a)(1)(B) of the act;

(2)Demonstrating safety with respect to individuals exposed to the new animal drug through its manufacture and use under section 572(c)(1)(F) of the act;

(3)Conducting an environmental assessment under section 572(c)(1)(E) of the act; or

(4)Obtaining approval of a new animal drug application or abbreviated new animal drug application under section 512(b) of the act.

(b)Correspondence and information associated with investigations described in paragraph

(a)of this section shall not be sent to the Director, OMUMS, but shall be submitted to FDA in accordance with the provisions of part 511 of this chapter.

(c)The investigational use of a new animal drug or animal feed bearing or containing a new animal drug intended solely for investigational use in minor species, other than for an investigational use described in paragraph

(a)of this section, shall meet the requirements of this section. For such investigations, all provisions of part 511 of this chapter apply with the following modifications:

(1)Under § 511.1(a)(1) of this chapter, the label statement is as follows: “ *Caution* . Contains a new animal drug for investigational use only in laboratory animals or for tests in vitro in support of index listing. Not for use in humans.”

(2)Under § 511.1(b)(1) of this chapter, the label statement is as follows: “ *Caution* . Contains a new animal drug for use only in investigational animals in clinical trials in support of index listing. Not for use in humans. Edible products of investigational animals are not to be used for food for humans or other animals unless authorization has been granted by the U.S. Food and Drug Administration or by the U.S. Department of Agriculture.”

(3)Under § 511.1(b)(4) of this chapter, the notice is titled “Notice of Claimed Investigational Exemption for a New Animal Drug for Index Listing” and is submitted in duplicate to the Director, OMUMS.

(4)Under § 511.1(c)(3) of this chapter, if an investigator is determined to be ineligible to receive new animal drugs, each “Notice of Claimed Investigational Exemption for a New Animal Drug for Index Listing” and each request for indexing shall be examined with respect to the reliability of information submitted by the investigator.

(5)Under § 511.1(c)(4) and (d)(2) of this chapter, with respect to termination of exemptions, the sponsor of an investigation shall not be granted an opportunity for a regulatory hearing before FDA pursuant to part 16 of this chapter. Instead, the sponsor shall have an opportunity for an informal conference as described in § 516.123.

(6)Under § 511.1(c)(5) of this chapter, if the Commissioner of Food and Drugs determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are such that a request for addition to the index would have been denied, FDA will remove the new animal drug from the index in accordance with § 516.167.

(d)The investigational use of a new animal drug or animal feed bearing or containing a new animal drug subject to paragraph

(c)of this section shall not be subject to the good laboratory practice requirements in part 58 of this chapter.

(e)Correspondence and information associated with investigations described in paragraph

(c)of this section shall be sent to the Director, OMUMS, in accordance with the provisions of this section. § 516.129 Content and format of a request for determination of eligibility for indexing.

(a)Each request for determination of eligibility:

(1)May involve only one drug (or one combination of drugs) in one dosage form;

(2)May not involve a new animal drug that is contained in or a product of a transgenic animal;

(3)May not involve the same drug in the same dosage form for the same intended use as a drug that is already approved or conditionally approved; and

(4)Must be submitted separately.

(b)A request for determination of eligibility for indexing may involve multiple intended uses and/or multiple minor species. However, if a request for determination of eligibility for indexing that contains multiple intended uses and/or multiple minor species cannot be granted in any part, the entire request will be denied.

(c)A requestor must submit two copies of a dated request signed by the authorized contact person for determination of eligibility for indexing that contains the following:

(1)Identification of the minor species or groups of minor species for which the new animal drug is intended;

(2)Information regarding drug components and composition;

(3)A statement of the intended use(s) of the new animal drug in the identified minor species or groups of minor species;

(4)A statement of the proposed conditions of use associated with the stated intended use(s) of the new animal drug, including the proposed dosage, route of administration, contraindications, warnings, and any other significant limitations associated with the intended use(s) of the new animal drug;

(5)A brief discussion of the need for the new animal drug for the intended use(s);

(6)An estimate of the anticipated annual distribution of the new animal drug, in terms of the total quantity of active ingredient, after indexing;

(7)Information to establish that the new animal drug is intended for use:

(i)In a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals; or

(ii)In a hatchery, tank, pond, or other similar contained man-made structure in (which includes on) an early, non-food life stage of a food-producing minor species, and information to demonstrate food safety in accordance with the standards of section 512(d) of the act and § 514.111 of this chapter (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance);

(8)A description of the methods used in, and the facilities and controls used for, the manufacture, processing and packing of the new animal drug sufficient to demonstrate that the requestor has established appropriate specifications for the manufacture and control of the new animal drug and that the requestor has an understanding of current good manufacturing practices;

(9)Either a claim for categorical exclusion under § 25.30 or § 25.33 of this chapter or an environmental assessment under § 25.40 of this chapter;

(10)Information sufficient to support the conclusion that the new animal drug is safe under section 512(d) of the act with respect to individuals exposed to the new animal drug through its manufacture and use; and

(11)The name and address of the contact person or permanent-resident U.S. agent. § 516.131 Refuse to file a request for determination of eligibility for indexing.

(a)If a request for determination of eligibility for indexing contains all of the information required by § 516.129, FDA shall file it, and the filing date shall be the date FDA receives the request.

(b)If a request for a determination of eligibility lacks any of the information required by § 516.129, FDA will not file it, but will inform the requestor in writing within 30 days of receiving the request as to what information is lacking. § 516.133 Denying a request for determination of eligibility for indexing.

(a)FDA will deny a request for determination of eligibility for indexing if it determines upon the basis of the request evaluated together with any other information before it with respect to the new animal drug that:

(1)The same drug in the same dosage form for the same intended use is already approved or conditionally approved;

(2)There is insufficient information to demonstrate that the new animal drug is intended for use:

(i)In a minor species for which there is a reasonable certainty that the animal or edible products from the animal will not be consumed by humans or food-producing animals, or

(ii)In a hatchery, tank, pond, or other similar contained man-made structure in (which includes on) an early, non-food life stage of a food-producing minor species, and there is insufficient evidence to demonstrate safety for humans in accordance with the standard of section 512(d) of the act and § 514.111 of this chapter (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance);

(3)The new animal drug is contained in or is a product of a transgenic animal;

(4)There is insufficient information to demonstrate that the requestor has established appropriate specifications for the manufacture and control of the new animal drug and that the requestor has an understanding of current good manufacturing practices;

(5)The requester fails to submit an adequate environmental assessment under § 25.40 of this chapter or fails to provide sufficient information to establish that the requested action is subject to categorical exclusion under § 25.30 or § 25.33 of this chapter;

(6)There is insufficient information to determine that the new animal drug is safe with respect to individuals exposed to the new animal drug through its manufacture or use; or

(7)The request for determination of eligibility for indexing fails to contain any other information required under the provisions of § 516.129.

(b)FDA may deny a request for determination of eligibility for indexing if it contains any untrue statement of a material fact or omits material information.

(c)When a request for determination of eligibility for indexing is denied, FDA will notify the requestor in accordance with § 516.137. § 516.135 Granting a request for determination of eligibility for indexing.

(a)FDA will grant the request for determination of eligibility for indexing if none of the reasons described in § 516.133 for denying such a request applies.

(b)When a request for determination of eligibility for indexing is granted, FDA will notify the requestor in accordance with § 516.137. § 516.137 Notification of decision regarding eligibility for indexing.

(a)Within 90 days after the filing of a request for a determination of eligibility for indexing based on § 516.129(c)(7)(i), or 180 days for a request based on § 516.129(c)(7)(ii), FDA shall grant or deny the request, and notify the requestor of FDA's decision in writing.

(b)If FDA denies the request, FDA shall provide due notice and an opportunity for an informal conference as described in § 516.123 regarding its decision. A decision of FDA to deny a request for determination of eligibility for indexing following an informal conference shall constitute final agency action subject to judicial review. § 516.141 Qualified expert panels.

(a)*Establishment of a qualified expert panel* . Establishing a qualified expert panel is the first step in the process of requesting the addition of a new animal drug to the index. A qualified expert panel may not be established until FDA has determined that the new animal drug is eligible for indexing. The requestor must choose members for the qualified expert panel in accordance with selection criteria listed in paragraph

(b)of this section and submit information about these proposed members to FDA. FDA must determine whether the proposed qualified expert panel meets the selection criteria prior to the panel beginning its work. Qualified expert panels operate external to FDA and are not subject to the Federal Advisory Committee Act, as amended, 5 U.S.C. App.

(b)*Criteria for the selection of a qualified expert panel* .

(1)A qualified expert panel member must be an expert qualified by training and experience to evaluate a significant aspect of target animal safety or effectiveness of the new animal drug under consideration.

(2)A qualified expert panel member must certify that he or she has a working knowledge of section 572 of the act (the indexing provisions of the statute) and this subpart, and that he or she has also read and understood a clear written statement provided by the requestor stating his or her duties and responsibilities with respect to reviewing the new animal drug proposed for addition to the index.

(3)A qualified expert panel member may not be an FDA employee.

(4)A qualified expert panel must have at least three members.

(5)A qualified expert panel must have members with a range of expertise such that the panel, as a whole, is qualified by training and experience to evaluate the target animal safety and effectiveness of the new animal drug under consideration.

(6)Unless FDA makes a determination to allow participation notwithstanding an otherwise disqualifying financial interest, a qualified expert panel member must not have a conflict of interest or the appearance of a conflict of interest, as described in paragraph

(g)of this section.

(c)*Requestor responsibilities* .

(1)The requestor must:

(i)Choose members for the qualified expert panel in accordance with selection criteria listed in paragraph

(b)of this section.

(ii)Provide each potential expert panel member a copy of section 572 of the act (the indexing provisions of the statute) and this subpart and obtain certification that he or she has a working knowledge of the information.

(iii)Provide each potential expert panel member a written statement describing the purpose and scope of his or her participation on the qualified expert panel and obtain certification that he or she has read and understood the information. The written statement should describe the duties and responsibilities of qualified expert panels and their members established by paragraphs

(e)and

(f)of this section, including the need to prepare a written report under § 516.143.

(iv)Obtain information from each potential expert panel member demonstrating that he or she is qualified by training and experience to evaluate the target animal safety and effectiveness of the new animal drug under consideration. This information can be obtained from a comprehensive curriculum vitae or similar document.

(v)Notify each potential expert panel member that he or she must submit information relating to potential conflict of interest directly to FDA in a timely manner, as required in paragraph (e)(6) of this section.

(2)The requestor must submit, in writing, the names and addresses of the proposed qualified expert panel members and sufficient information about each proposed member for FDA to determine whether the panel meets the selection criteria listed in paragraphs (b)(1) through (b)(5) of this section.

(3)After FDA has determined that the qualified expert panel meets the selection criteria, the requestor must provide to the panel all information known by the requestor that is relevant to a determination of the target animal safety and the effectiveness of the new animal drug at issue. In addition, the requestor must notify FDA of the name of the qualified expert panel leader.

(4)The requestor must immediately notify FDA if it believes a qualified expert panel member no longer meets the selection criteria listed in paragraph

(b)of this section or is otherwise not in compliance with the requirements of this section.

(5)If a qualified expert panel member cannot complete the review for which he or she was selected, the requestor must either choose a replacement or justify the continued work of the panel in the absence of the lost panelist. In either case, the requestor must submit sufficient information for FDA to determine whether the proposed revised qualified expert panel meets the selection criteria listed in paragraphs (b)(1) through (b)(5) of this section.

(6)The requestor must keep copies of all information provided to, or received from, qualified expert panel members, including the written report, for 2 years after the completion of the report, or the product is added to the index, whichever occurs later, and make them available to a duly authorized employee of the agency at all reasonable times.

(d)*FDA responsibilities* .

(1)FDA will determine whether the requestor's proposed qualified expert panel meets the selection criteria listed in paragraph

(b)of this section. FDA will expeditiously inform the requestor, in writing, of its determination. If FDA determines that the qualified expert panel does not meet the selection criteria, FDA will provide due notice and an opportunity for an informal conference as described in § 516.123. A determination by FDA that a proposed qualified expert panel does not meet the selection criteria following an informal conference shall constitute final agency action subject to judicial review.

(2)If FDA determines that a qualified expert panel no longer meets the selection criteria listed in paragraph

(b)of this section or that the panel or its members are not in compliance with the requirements of this section, the agency will expeditiously inform the requestor, in writing, of this determination and provide due notice and an opportunity for an informal conference as described in § 516.123. A determination by FDA, following an informal conference, that a qualified expert panel no longer meets the selection criteria listed in paragraph

(b)of this section or that the panel or its members are not in compliance with the requirements of this section shall constitute final agency action subject to judicial review.

(e)*Responsibilities of a qualified expert panel member* . A qualified expert panel member must do the following:

(1)Continue to meet all selection criteria described in paragraph

(b)of this section.

(2)Act in accordance with generally accepted professional and ethical business practices.

(3)Review all information relevant to a determination of the target animal safety and effectiveness of the new animal drug provided by the requestor. The panel should also consider all relevant information otherwise known by the panel members, including anecdotal information.

(4)Participate in the preparation of the written report of the findings of the qualified expert panel, described in § 516.143.

(5)Sign, or otherwise approve in writing, the written report. Such signature or other written approval will serve as certification that the written report meets the requirements of the written report in § 516.143.

(6)Provide the information relating to potential conflict of interest described in paragraph

(g)of this section to FDA for its consideration. Such information should be submitted directly to the Director, OMUMS, when notified by the requestor.

(7)Immediately notify the requestor and FDA of any change in conflict of interest status.

(8)Certify at the time of submission of the written report that there has been no change in conflict of interest status, or identify and document to FDA any such change.

(f)*Additional responsibilities of a qualified expert panel leader* .

(1)The qualified expert panel leader must ensure that the activities of the panel are performed efficiently and in accordance with generally accepted professional and ethical business practices.

(2)The qualified expert panel leader serves as the principal point of contact between representatives of the agency and the panel.

(3)The qualified expert panel leader is responsible for submitting the written report and all notes or minutes relating to panel deliberations to the requestor.

(4)The qualified expert panel leader must maintain a copy of the written report and all notes or minutes relating to panel deliberations that are submitted to the requestor for 2 years after the report is submitted. Such records must be made available to a duly authorized employee of the agency for inspection at all reasonable times.

(g)*Prevention of conflicts of interest* .

(1)For the purposes of this subpart, FDA will consider a conflict of interest to be any financial or other interest that could impair a person's objectivity in serving on the qualified expert panel or could create an unfair competitive advantage for a person or organization.

(2)Factors relevant to whether there is a conflict of interest or the appearance of a conflict of interest include whether the qualified expert panel member, their spouse, their minor children, their general partners, or any organizations in which they serve as an officer, director, trustee, general partner or employee:

(i)Is currently receiving or seeking funding from the requestor through a contract or research grant (either directly or indirectly through another entity, such as a university).

(ii)Has any employment, contractual, or other financial arrangement with the requestor other than receiving a reasonable fee for serving as a member of the qualified expert panel.

(iii)Has any ownership or financial interest in any drug, drug manufacturer, or drug distributor which will benefit from either a favorable or unfavorable evaluation or opinion.

(iv)Has any ownership or financial interest in the new animal drug being reviewed by the qualified expert panel.

(v)Has participated in the design, manufacture, or distribution of any drug that will benefit from either a favorable or unfavorable opinion of the qualified expert panel.

(vi)Has provided within 1 year any consultative services regarding the new animal drug being reviewed by the qualified expert panel.

(vii)Has entered into an agreement in which fees charged or accepted are contingent upon the panel member making a favorable evaluation or opinion.

(viii)Receives payment for services related to preparing information the requestor presents to the qualified expert panel, other than for services related to the written report described in § 516.143.

(3)To permit FDA to make a decision regarding potential conflict of interest, a potential qualified expert panel member must submit to the Director, OMUMS, the following information relating to themselves, their spouse, their minor children, their general partners, or any organizations in which they serve as an officer, director, trustee, general partner or employee, regarding the following issues to the extent that they are, in any way, relevant to the subject of the review of the qualified expert panel:

(i)Investments (for example, stocks, bonds, retirement plans, trusts, partnerships, sector funds, etc.), including for each the following: Name of the firm, type of investment, owner (self, spouse, etc.), number of shares / current value.

(ii)Employment (full or part time, current or under negotiation), including for each the following: Name of the firm, relationship (self, spouse, etc.), position in firm, date employment or negotiation began.

(iii)Consultant/advisor (current or under negotiation), including for each the following: Name of the firm, topic/issue, amount received, date initiated.

(iv)Contracts, grants, Cooperation Research and Development Agreement (CRADAs) (current or under negotiation), including for each the following: Type of agreement, product under study and indications, amount of remuneration (institution/self), time period, sponsor (government, firm, institution, individual), role of the person (site investigator, principal investigator, co-investigator, partner, no involvement, other), awardee.

(v)Patents/royalties/trademarks, including for each the following: Description, name of firm involved, income received.

(vi)Expert witness (last 12 months or under negotiation), including for each the following: For or against, name of firm, issue, amount received.

(vii)Speaking/writing (last 12 months or under negotiation), including for each the following: Firm, topic/issue, amount received (honorarium/travel), date.

(viii)Whether the potential qualified expert panel member, their spouse, their minor children, their general partners or any organizations in which they serve as an officer, director, trustee, general partner or employee, have had, at any time in the past, involvement of the kind noted in paragraph (g)(3)(i) through (g)(3)(vii) of this section with respect to the animal drug that is the subject of the qualified expert panel review.

(ix)Whether there are any other involvements (other kinds of relationships) that would give the appearance of a conflict of interest which have not been described in paragraph (g)(3)(i) through (g)(3)(viii) of this section.

(x)In all cases, a response of “no,” “none,” or “not applicable” is satisfactory when there is no relevant information to submit.

(xi)A certification statement signed by the potential qualified expert panel member to the effect that all information submitted is true and complete to the best of their knowledge, that they have read and understood their obligations as an expert panel member, and that they will notify FDA and the requestor of any change in their conflict of interest status.

(4)The fact that a qualified expert panel member receives a reasonable fee for services as a member of the qualified expert panel, provided that the fee is no more than commensurate with the value of the time that the member devotes to the review process, does not constitute a conflict of interest or the appearance of a conflict of interest. § 516.143 Written report. The written report required in § 516.145(b)(3) shall:

(a)Be written in English by a qualified expert panel meeting the requirements of § 516.141;

(b)Describe the panel's evaluation of all available target animal safety and effectiveness information relevant to the proposed use of the new animal drug, including anecdotal information;

(c)For all information considered, including anecdotal information, include either a citation to published literature or a summary of the information;

(d)State the panel's opinion regarding whether the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question;

(e)Be signed, or otherwise approved in writing, by all panel members, in accordance with § 516.141; and

(f)If the panel unanimously concludes that the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question, the written report shall:

(1)Provide draft labeling that includes all conditions of use and limitations of use of the new animal drug deemed necessary by the panel to assure that the benefits of use of the new animal drug outweigh the risks, or provide narrative information from which such labeling can be written by the requestor; and

(2)Include a recommendation regarding whether the new animal drug should be limited to use under the professional supervision of a licensed veterinarian. § 516.145 Content and format of a request for addition to the index.

(a)A requestor may request addition of a new animal drug to the index only after the new animal drug has been granted eligibility for indexing.

(b)A requestor shall submit two copies of a dated request signed by the authorized contact for addition of a new animal drug to the index that contains the following:

(1)A copy of FDA's determination of eligibility issued under § 516.137;

(2)A copy of FDA's written determination that the proposed qualified expert panel meets the selection criteria provided for in § 516.141(b);

(3)A written report that meets the requirements of § 516.143;

(4)A proposed index entry that contains the information described in § 516.157;

(5)Proposed labeling, including representative labeling proposed to be used for Type B and Type C medicated feeds if the drug is intended for use in the manufacture of medicated feeds;

(6)Anticipated annual distribution of the new animal drug, in terms of the total quantity of active ingredient, after indexing;

(7)A written commitment to manufacture the new animal drug and animal feeds bearing or containing such new animal drug according to current good manufacturing practices;

(8)A written commitment to label, distribute, and promote the new animal drug only in accordance with the index entry;

(9)The name and address of the contact person or permanent-resident U.S. agent; and

(10)A draft Freedom of Information summary which includes the following information:

(i)A general information section that contains the name and address of the requestor and a description of the drug, route of administration, indications, and recommended dosage.

(ii)A list of the names and affiliations of the members of the qualified expert panel, not including their addresses or other contact information.

(iii)A summary of the findings of the qualified expert panel concerning the target animal safety and effectiveness of the drug.

(iv)Citations of all publicly-available literature considered by the qualified expert panel.

(v)For an early life stage of a food-producing minor species animal, a human food safety summary.

(c)Upon specific request by FDA, the requestor shall submit the information described in § 516.141 that it submitted to the qualified expert panel. Any such information not in English should be accompanied by an English translation. § 516.147 Refuse to file a request for addition to the index.

(a)If a request for addition to the index contains all of the information required by § 516.145(b), FDA shall file it, and the filing date shall be the date FDA receives the request.

(b)If a request for addition to the index lacks any of the information required by § 516.145, FDA will not file it, but will inform the requestor in writing within 30 days of receiving the request as to what information is lacking. § 516.149 Denying a request for addition to the index.

(a)FDA will deny a request for addition to the index if it finds the following:

(1)The same drug in the same dosage form for the same intended use is already approved or conditionally approved;

(2)On the basis of new information, the new animal drug no longer meets the conditions for eligibility for indexing;

(3)The request for indexing fails to contain information required under the provisions of § 516.145;

(4)The qualified expert panel fails to meet any of the selection criteria listed in § 516.141(b);

(5)The written report of the qualified expert panel and other information available to FDA is insufficient to permit FDA to determine that the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question;

(6)On the basis of the report of the qualified expert panel and other information available to FDA, the benefits of using the new animal drug for the proposed use in a minor species do not outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question; or

(7)The request contains any untrue statement of a material fact or omits material information.

(b)When a request for addition to the index is denied, FDA will notify the requestor in accordance with § 516.153. § 516.151 Granting a request for addition to the index.

(a)FDA will grant the request for addition of a new animal drug to the index if none of the reasons described in § 516.149 for denying such a request applies.

(b)When a request for addition of a new animal drug to the index is granted, FDA will notify the requestor in accordance with § 516.153. § 516.153 Notification of decision regarding index listing.

(a)Within 180 days after the filing of a request for addition of a new animal drug to the index, FDA shall grant or deny the request and notify the requestor of FDA's decision in writing.

(b)If FDA denies the request for addition of a new animal drug to the index, FDA shall provide due notice and an opportunity for an informal conference as described in § 516.123. A decision of FDA to deny a request to index a new animal drug following an informal conference shall constitute final agency action subject to judicial review. § 516.155 Labeling of indexed drugs.

(a)The labeling of an indexed drug that is found to be eligible for indexing under § 516.129(c)(7)(i) shall state, prominently and conspicuously: *“NOT APPROVED BY FDA.—Legally marketed as an FDA indexed product. Extra-label use is prohibited.” “This product is not to be used in animals intended for use as food for humans or other animals.”*

(b)The labeling of an indexed drug that was found to be eligible for indexing for use in an early, non-food life stage of a food-producing minor species animal, under § 516.129(c)(7)(ii), shall state, prominently and conspicuously: *“NOT APPROVED BY FDA.—Legally marketed as an FDA indexed product. Extra-label use is prohibited.”*

(c)The labeling of an indexed drug shall contain such other information as may be prescribed in the index listing. § 516.157 Publication of the index and content of an index listing.

(a)FDA will make the list of indexed drugs available through the FDA Web site. A printed copy can be obtained by writing to the FDA Freedom of Information Staff or by visiting the FDA Freedom of Information Public Reading Room.

(b)The list will contain the following information for each indexed drug:

(1)The name and address of the person who holds the index listing;

(2)The name of the drug and the intended use and conditions of use for which it is indexed;

(3)Product labeling; and

(4)Conditions and any limitations that FDA deems necessary regarding use of the drug. § 516.161 Modifications to indexed drugs.

(a)After a drug is listed in the index, certain modifications to the index listing may be requested. Any modification of an index listing may not cause an indexed drug to be a different drug (or different combination of drugs) or a different dosage form. If such modification is requested, FDA will notify the holder that a new index listing is required for the new drug or dosage form.

(b)Modifications to the indexed drug will fall under one of three categories and must be submitted as follows:

(1)*Urgent changes* .

(i)The following modifications to an indexed drug or its labeling should be made as soon as possible, and a request to modify the indexed drug should be concurrently submitted:

(A)The addition to package labeling, promotional labeling, or prescription drug advertising of additional warning, contraindication, side effect, or cautionary information.

(B)The deletion from package labeling, promotional labeling, and drug advertising of false, misleading, or unsupported indications for use or claims for effectiveness.

(C)Changes in manufacturing methods or controls required to correct product or manufacturing defects that may result in serious adverse drug events.

(ii)The modifications described in paragraph (b)(1)(i) of this section must be submitted to the Director, OMUMS, in the form of a request for modification of an indexed drug, and must contain sufficient information to permit FDA to determine the need for the modification and whether the modification appropriately addresses the need.

(iii)FDA will take no action against an indexed drug or index holder solely because modifications of the kinds described in paragraph (b)(1)(i) of this section are placed into effect by the holder prior to receipt of a written notice granting the request if all the following conditions are met:

(A)A request to modify the indexed drug providing a full explanation of the basis for the modifications has been submitted, plainly marked on the mailing cover and on the request as follows: “Special indexing request— modifications being effected;”

(B)The holder specifically informs FDA of the date on which such modifications are to be effected and submits two printed copies of any revised labeling to be placed in use, and

(C)All promotional labeling and all drug advertising are promptly revised consistent with modifications made in the labeling on or within the indexed drug package.

(2)*Significant changes* .

(i)The following modifications to an indexed drug or its labeling may be made only after a request has been submitted to and subsequently granted by FDA:

(A)Addition of an intended use.

(B)Addition of a species.

(C)Addition or alteration of an active ingredient.

(D)Alteration of the concentration of an active ingredient.

(E)Alteration of dose or dosage regimen.

(F)Alteration of prescription or over-the-counter status.

(ii)Each modification described in paragraph (b)(2)(i) of this section must go through the same review process as an original index listing and is subject to the same standards for review.

(iii)Each submission of a request for a modification described in paragraph (b)(2)(i) of this section should contain only one type of modification unless one modification is actually necessitated by another, such as a modification of dose necessitated by a modification of the concentration of an active ingredient. Submissions relating to addition of an intended use for an existing species or addition of a species should be submitted separately, but each such submission may include multiple additional intended uses and/or multiple additional species.

(3)*Minor changes* . All modifications other than those described in paragraphs (b)(1) and (b)(2) of this section including, but not limited to, formulation, labeling, and manufacturing methods and controls (at the same level of detail that these were described in the request for determination of eligibility for indexing) must be submitted as part of the annual indexed drug experience report or as otherwise required by § 516.165.

(c)When changes affect the index listing, it will be updated accordingly. § 516.163 Change in ownership of an index file.

(a)A holder may transfer ownership of a drug's index file to another person.

(1)The former owner shall submit in writing to FDA a statement that all rights in the index file have been transferred, giving the name and address of the new owner and the date of the transfer. The former owner shall also certify that a complete copy of the following, to the extent that they exist at the time of the transfer of ownership, has been provided to the new owner:

(i)The request for determination of eligibility;

(ii)The request for addition to the index;

(iii)Any modifications to the index listing;

(iv)Any records and reports under § 516.165; and

(v)All correspondence with FDA relevant to the indexed drug and its index listing.

(2)The new owner shall submit the following information in writing to FDA:

(i)The date that the change in ownership is effective;

(ii)A statement that the new owner has a complete copy of all documents listed in paragraph (a)(1) of this section to the extent that they exist at the time of the transfer of ownership;

(iii)A statement that the new owner understands and accepts the responsibilities of a holder of an indexed drug;

(iv)The name and address of a new primary contact person or permanent-resident U.S. agent; and

(v)A list of labeling changes associated with the change of ownership (e.g., a new trade name) as draft labeling, with complete final printed labeling to be submitted in the indexed drug annual report in accordance with §§ 516.161 and 516.165.

(b)Upon receiving the necessary information to support a change of ownership of a drug's index file, FDA will update its publicly-available listing in accordance with § 516.157. § 516.165 Records and reports.

(a)*Scope and purpose* .

(1)The recordkeeping and reporting requirements of this section apply to all holders of indexed drugs, including indexed drugs intended for use in medicated feeds.

(2)A holder is not required to report information under this section if the holder has reported the same information under § 514.80 of this chapter.

(3)The records and reports referred to in this section are in addition to those required by the current good manufacturing practice regulations in parts 211, 225, and 226 of this chapter.

(4)FDA will review the records and reports required in this section to determine, or facilitate a determination, whether there may be grounds for removing a drug from the index under section 572(f) of the act.

(b)*Recordkeeping requirements* .

(1)Each holder of an indexed drug must establish and maintain complete files containing full records of all information pertinent to the safety or effectiveness of the indexed drug. Such records must include information from foreign and domestic sources.

(2)The holder must, upon request from any authorized FDA officer or employee, at all reasonable times, permit such officer or employee to have access to copy and to verify all such records.

(c)*Reporting requirements* .

(1)*Three-day indexed drug field alert report* . The holder must inform the appropriate FDA District Office or local FDA resident post of any product or manufacturing defects that may result in serious adverse drug events within 3 working days of first becoming aware that such a defect may exist. The holder may initially provide this information by telephone or other electronic communication means, with prompt written followup. The mailing cover must be plainly marked “3-Day Indexed Drug Field Alert Report.”

(2)*Fifteen-day indexed drug alert report* . The holder must submit a report on each serious, unexpected adverse drug event, regardless of the source of the information. The holder must submit the report within 15 working days of first receiving the information. The mailing cover must be plainly marked “15-Day Indexed Drug Alert Report.”

(3)*Annual indexed drug experience report* . The holder must submit this report every year on the anniversary date of the letter granting the request for addition of the new animal drug to the index, or within 60 days thereafter. The report must contain data and information for the full reporting period. Any previously submitted information contained in the report must be identified as such. The holder may ask FDA to change the date of submission and, after approval of such request, file such reports by the new filing date. The report must contain the following:

(i)The number of distributed units of each size, strength, or potency (e.g., 100,000 bottles of 100 5-milligram tablets; 50,000 10-milliliter vials of 5- percent solution) distributed during the reporting period. This information must be presented in two categories: Quantities distributed domestically and quantities exported. This information must include any distributor-labeled product.

(ii)If the labeling has changed since the last report, include a summary of those changes and the holder's and distributor's current package labeling, including any package inserts. For large-size package labeling or large shipping cartons, submit a representative copy (e.g., a photocopy of pertinent areas of large feed bags). If the labeling has not changed since the last report, include a statement of such fact.

(iii)A summary of any changes made during the reporting period in the methods used in, and facilities and controls used for, manufacture, processing, and packing. This information must be presented in the same level of detail that it was presented in the request for determination of eligibility for indexing. Do not include changes that have already been submitted under § 516.161.

(iv)Nonclinical laboratory studies and clinical data not previously reported under this section.

(v)Adverse drug experiences not previously reported under this section.

(vi)Any other information pertinent to safety or effectiveness of the indexed drug not previously reported under this section.

(4)*Distributor's statement* . At the time of initial distribution of an indexed drug by a distributor, the holder must submit a report containing the following:

(i)The distributor's current product labeling. This must be identical to that in the index listing except for a different and suitable proprietary name (if used) and the name and address of the distributor. The name and address of the distributor must be preceded by an appropriate qualifying phrase such as “manufactured for” or “distributed by.”

(ii)A signed statement by the distributor stating:

(A)The category of the distributor's operations (e.g., wholesale or retail);

(B)That the distributor will distribute the drug only under the indexed drug labeling;

(C)That the distributor will promote the indexed drug only for use under the conditions stated in the index listing; and

(D)If the indexed drug is a prescription new animal drug, that the distributor is regularly and lawfully engaged in the distribution or dispensing of prescription products.

(5)*Other reporting* . FDA may by order require that a holder submit information in addition to that required by this section or that the holder submit the same information but at different times or reporting periods. § 516.167 Removal from the index.

(a)After due notice to the holder of the index listing and an opportunity for an informal conference as described in § 516.123, FDA shall remove a new animal drug from the index if FDA finds that:

(1)The same drug in the same dosage form for the same intended use has been approved or conditionally approved;

(2)The expert panel failed to meet the requirements in § 516.141;

(3)On the basis of new information before FDA, evaluated together with the evidence available to FDA when the new animal drug was listed in the index, the benefits of using the new animal drug for the indexed use do not outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved new animal drug for the minor species in question;

(4)Any of the conditions in § 516.133(a)(2), (5), or

(6)are present;

(5)The manufacture of the new animal drug is not in accordance with current good manufacturing practices;

(6)The labeling, distribution, or promotion of the new animal drug is not in accordance with the index listing;

(7)The conditions and limitations of use associated with the index listing have not been followed; or

(8)Any information used to support the request for addition to the index contains any untrue statement of material fact.

(b)The agency may partially remove an indexing listing if, in the opinion of the agency, such partial removal would satisfactorily resolve a safety or effectiveness issue otherwise warranting removal of the listing under section 572(f)(1)(B) of the act.

(c)FDA may immediately suspend a new animal drug from the index if FDA determines that there is a reasonable probability that the use of the drug would present a risk to the health of humans or other animals. The agency will subsequently provide due notice and an opportunity for an informal conference as described in § 516.123.

(d)A decision of FDA to remove a new animal drug from the index following an informal conference, if any, shall constitute final agency action subject to judicial review. § 516.171 Confidentiality of data and information in an index file.

(a)For purposes of this section, the index file includes all data and information submitted to or incorporated by reference into the index file, such as data and information related to investigational use exemptions under § 516.125, requests for determination of eligibility for indexing, requests for addition to the index, modifications to indexed drugs, changes in ownership, reports submitted under § 516.165, and master files. The availability for public disclosure of any record in the index file shall be handled in accordance with the provisions of this section.

(b)The existence of an index file will not be disclosed by FDA before an index listing has been made public by FDA, unless it has previously been publicly disclosed or acknowledged by the requestor.

(c)If the existence of an index file has not been publicly disclosed or acknowledged, no data or information in the index file are available for public disclosure.

(d)If the existence of an index file has been publicly disclosed or acknowledged before an index listing has been made public by FDA, no data or information contained in the file will be available for public disclosure before such index listing is made public, but the agency may, at its discretion, disclose a brief summary of such selected portions of the safety and effectiveness data as are appropriate for public consideration of a specific pending issue, e.g., at an open session of a Food and Drug Administration advisory committee or pursuant to an exchange of important regulatory information with a foreign government.

(e)After FDA sends a written notice to the requestor granting a request for addition to the index, the following data and information in the index file are available for public disclosure unless extraordinary circumstances are shown:

(1)All safety and effectiveness data and information previously disclosed to the public, as defined in § 20.81 of this chapter.

(2)A summary or summaries of the safety and effectiveness data and information submitted with or incorporated by reference in the index file. Such summaries do not constitute the full information described under section 572(c) and

(d)of the act on which the safety or effectiveness of the drug may be determined. Such summaries will be based on the draft Freedom of Information summary submitted under § 516.145, which will be reviewed and, where appropriate, revised by FDA.

(3)A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61 of this chapter.

(4)Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of the following:

(i)Names and any information that would identify the person using the product.

(ii)Names and any information that would identify any third party involved with the report, such as a veterinarian.

(5)A list of all active ingredients and any inactive ingredients previously disclosed to the public as defined in § 20.81 of this chapter.

(6)An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in § 20.61 of this chapter.

(7)All correspondence and written summaries of oral discussions relating to the index file, in accordance with the provisions of part 20 of this chapter.

(f)The following data and information in an index file are not available for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 of this chapter, or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 20.61 of this chapter:

(1)Manufacturing methods or processes, including quality control procedures.

(2)Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.

(3)Quantitative or semiquantitative formulas.

(g)Subject to the disclosure provisions of this section, the agency shall regard the contents of an index file as confidential information unless specifically notified in writing by the holder of the right to disclose, to reference, or otherwise utilize such information on behalf of another named person.

(h)For purposes of this regulation, safety and effectiveness data include all studies and tests of an animal drug on animals and all studies and tests on the animal drug for identity, stability, purity, potency, and bioavailability.

(i)Safety and effectiveness data and information that have not been previously disclosed to the public are available for public disclosure at the time any of the following events occurs unless extraordinary circumstances are shown:

(1)No work is being or will be undertaken to have the drug indexed in accordance with the request.

(2)A final determination is made that the drug cannot be indexed and all legal appeals have been exhausted.

(3)The drug has been removed from the index and all legal appeals have been exhausted.

(4)A final determination has been made that the animal drug is not a new animal drug. PART 558— NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 36. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 37. Amend § 558.3 by revising the last sentence of paragraph (b)(2) and revising paragraphs (b)(5), (b)(6), and (b)(7) to read as follows: § 558.3 Definitions and general considerations applicable to this part.

(b)* * *

(2)* * * The manufacture of a Type A medicated article requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.

(5)A Type B or Type C medicated feed manufactured from a drug component (bulk or “drum-run” (dried crude fermentation product)) requires an application approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter.

(6)A “veterinary feed directive

(VFD)drug” is a new animal drug approved under section 512(b) of the Federal Food, Drug, and Cosmetic Act (the act) or listed in the index under section 572 of the act for use in or on animal feed. Use of a VFD drug must be under the professional supervision of a licensed veterinarian.

(7)A “veterinary feed directive” is a written statement issued by a licensed veterinarian in the course of the veterinarian's professional practice that orders the use of a VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use the VFD drug in or on an animal feed to treat the client's animals only in accordance with the directions for use approved or indexed by the Food and Drug Administration (FDA). A veterinarian may issue a VFD only if a valid veterinarian-client-patient relationship exists, as defined in § 530.3(i) of this chapter. 38. Amend § 558.5 by revising paragraphs

(c)and

(d)to read as follows: § 558.5 Requirements for liquid medicated feed.

(c)*What is required for new animal drugs intended for use in liquid feed* ? Any new animal drug intended for use in liquid feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) or index listed under section 572 of the act. Such approvals under section 512 of the act must be:

(1)An original NADA,

(2)A supplemental NADA, or

(3)An abbreviated NADA.

(d)*What are the approval requirements under section 512 of the act for new animal drugs intended for use in liquid feed* ? An approval under section 512 of the act for a new animal drug intended for use in liquid feed must contain the following information:

(1)Data, or a reference to data in a master file (MF), that shows the relevant ranges of conditions under which the drug will be chemically stable in liquid feed under field use conditions; and

(2)Data, or a reference to data in an MF, that shows that the drug is physically stable in liquid feed under field conditions; or

(3)Feed labeling with recirculation or agitation directions as follows:

(i)For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii)For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. 39. Amend § 558.6 by revising paragraphs (a)(4)(iv) and (a)(6) to read as follows: § 558.6 Veterinary feed directive drugs.

(a)* * *

(4)* * *

(iv)Approved or index listed indications for use.

(6)You must issue a VFD only for the approved or indexed conditions and indications for use of the VFD drug. PART 589—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED 40. The authority citation for 21 CFR part 589 continues to read as follows: Authority: 21 U.S.C. 321, 342, 343, 348, 371. 41. Revise § 589.1000 to read as follows: § 589.1000 Gentian violet. The Food and Drug Administration has determined that gentian violet has not been shown by adequate scientific data to be safe for use in animal feed. Use of gentian violet in animal feed causes the feed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act (the act), in the absence of a regulation providing for its safe use as a food additive under section 409 of the act, unless it is subject to an effective notice of claimed investigational exemption for a food additive under § 570.17 of this chapter, or unless the substance is intended for use as a new animal drug and is subject to an approved application under section 512 of the act, or an index listing under section 572 of the act, or an effective notice of claimed investigational exemption for a new animal drug under part 511 of this chapter or § 516.125 of this chapter. Dated: November 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-23580 Filed 12-5-07; 8:45 am] BILLING CODE 4160-01-S 72 234 Thursday, December 6, 2007 Presidential Documents Part V The President Proclamation 8209—National Pearl Harbor Remembrance Day, 2007 Title 3— The President Proclamation 8209 of December 4, 2007 National Pearl Harbor Remembrance Day, 2007 By the President of the United States of America A Proclamation On December 7, 1941, our Nation was viciously attacked at Pearl Harbor, America's Pacific Fleet was battered and broken, and more than 2,400 American lives were lost. On National Pearl Harbor Remembrance Day, America honors those brave individuals who made the ultimate sacrifice in defense of our homeland, and we recognize those veterans who with strength and resolve defended our Nation and advanced the cause of freedom during World War II. When it mattered most, an entire generation of Americans stepped forward to protect our freedom and to defend liberty. Their devotion to duty and willingness to serve a cause greater than self helped secure our future and our way of life. Liberty prevailed because of the sacrifice of these courageous patriots, and America and her allies preserved a world where democracy could flourish. Our Nation remains forever in the debt of these brave Americans. From the unprovoked attack at Pearl Harbor grew a steadfast resolve that has made America a defender of freedom around the world, and our mission continues as our men and women in uniform serve at home and in distant lands. Today, as we defend our Nation's founding ideals, we pay special tribute to those who lost their lives at Pearl Harbor, honor our veterans of World War II, and celebrate the liberty that makes America a lasting symbol of hope to the world. The Congress, by Public Law 103-308, as amended, has designated December 7 of each year as “National Pearl Harbor Remembrance Day.” NOW, THEREFORE, I, GEORGE W. BUSH, President of the United States of America, do hereby proclaim December 7, 2007, as National Pearl Harbor Remembrance Day. I encourage all Americans to observe this solemn occasion with appropriate ceremonies and activities. I urge all Federal agencies, interested organizations, groups, and individuals to fly the flag of the United States at half-staff this December 7 in honor of those who died as a result of their service at Pearl Harbor. IN WITNESS WHEREOF, I have hereunto set my hand this fourth day of December, in the year of our Lord two thousand seven, and of the Independence of the United States of America the two hundred and thirty-second. GWBOLD.EPS [FR Doc. 07-5991 Filed 12-5-07; 10:07 am]

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