Rules and Regulations. Final rule; request for comments

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BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25173; Directorate Identifier 2006-NE-24-AD; Amendment 39-14693; AD 2006-15-13] RIN 2120-AA64 Airworthiness Directives; McCauley Propeller Systems Propeller Models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/114HCA-0, and C5JFR36C1104/L114HCA-0 AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule; request for comments. SUMMARY: The FAA is adopting a new airworthiness directive

(AD)for McCauley Propeller Systems propeller models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/114HCA-0, and C5JFR36C1104/L114HCA-0. This AD requires a onetime fluorescent penetrant inspection

(FPI)and eddy current inspection

(ECI)of propeller blades for cracks, and if any crack indications are found, removing the blade from service. This AD results from a report of two propeller blades on the same propeller assembly, found cracked during propeller overhaul. We are issuing this AD to detect cracks in the propeller blade that could cause failure and separation of the propeller blade and loss of control of the airplane. DATES: This AD becomes effective August 10, 2006. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of August 10, 2006. We must receive any comments on this AD by September 25, 2006. ADDRESSES: Use one of the following addresses to comment on this AD: • DOT Docket Web site: Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • Government-wide rulemaking Web site: Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-0001. • Fax:

(202)493-2251. • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact McCauley Propeller Systems, 7751 East Pawnee, Wichita, KS 67277 for the service information referenced in this AD. FOR FURTHER INFORMATION CONTACT: Jeff Janusz, Aerospace Engineer, Wichita Aircraft Certification Office, FAA, Small Airplane Directorate, 1801 Airport Road, Room 100, Wichita, KS 67209, telephone:

(316)946-4148; fax:

(316)946-4107. SUPPLEMENTARY INFORMATION: In May 2006, McCauley Propeller Systems received a report from an operator of two propeller blades found cracked during propeller overhaul. The propeller blades were installed on the same propeller assembly; on a “Jetstream 41” airplane. The cracks were located in the propeller blade retention groove, near the ledge where the split retainers seat and on or near the shot peened surface of the retention groove. To date, no further reports of these cracks have been received, and we know of no propeller blade failures due to these cracks. The FAA is continuing to investigate, however, and we may issue further ADs based on the inspection results reported to us under this AD. In order to assess the extent of any problem, we need to have all the inspection results reported to us, even those showing that no crack indications were found. This condition, if not corrected, could result in a failure and separation of the propeller blade and loss of control of the airplane. Relevant Service Information We have reviewed and approved the technical contents of McCauley Propellers Alert Service Bulletin

(ASB)ASB252, dated June 6, 2006. That ASB describes procedures for performing a onetime FPI and ECI of propeller blades for cracks. FAA's Determination and Requirements of This AD The unsafe condition described previously is likely to exist or develop on other McCauley Propeller Systems propeller models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/114HCA-0, and C5JFR36C1104/L114HCA-0 of the same type design. For that reason, we are issuing this AD to detect cracks in the propeller blade that could cause failure and separation of the propeller blade and loss of control of the airplane. This AD requires for certain blades, a onetime FPI and ECI of propeller blades for cracks within 100 operating hours time-in-service after the effective date of the AD, and if any crack indications are found, removal from service. You must use the service information described previously to perform the actions required by this AD. FAA's Determination of the Effective Date Since an unsafe condition exists that requires the immediate adoption of this AD, we have found that notice and opportunity for public comment before issuing this AD are impracticable, and that good cause exists for making this amendment effective in less than 30 days. Interim Action These actions are interim actions and we may take further rulemaking actions in the future. Comments Invited This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to send us any written relevant data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES . Include “AD Docket No. FAA-2006-25173; Directorate Identifier 2006-NE-24-D” in the subject line of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify it. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of the DMS Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78) or you may visit *http://dms.dot.gov.* Examining the AD Docket You may examine the docket that contains the AD, any comments received, and any final disposition in person at the Docket Management Facility Docket Offices between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone

(800)647-5227) is located on the plaza level of the Department of Transportation Nassif Building at the street address stated in ADDRESSES . Comments will be available in the AD docket shortly after the DMS receives them. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect 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. For the reasons discussed above, I certify that the regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Under the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive: **2006-15-13 McCauley Propeller Systems:** Amendment 39-14693. Docket No. FAA-2006-25173; Directorate Identifier 2006-NE-24-AD. Effective Date

(a)This airworthiness directive

(AD)becomes effective August 10, 2006. Affected ADs

(b)None. Applicability

(c)This AD applies to McCauley Propeller Systems propeller models B5JFR36C1101/114GCA-0, C5JFR36C1102/L114GCA-0, B5JFR36C1103/114HCA-0, and C5JFR36C1104/L114HCA-0. These propellers are installed on BAE Systems (Operations) Limited Jetstream Model 4100 and 4101 series airplanes (Jetstream 41). Unsafe Condition

(d)This AD results from a report of two propeller blades on the same propeller assembly, found cracked during propeller overhaul. We are issuing this AD to detect cracks in the propeller blade that could cause failure and separation of the propeller blade and loss of control of the airplane. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done. Onetime Propeller Blade Inspection

(f)Perform a onetime fluorescent penetrant inspection and eddy current inspection of propeller blades, using the Equipment Required and Accomplishment Instructions of McCauley Propellers Alert Service Bulletin ASB252, dated June 6, 2006, using the following compliance schedule: Table 1.—Compliance Schedule If the propeller blade: Then inspect the propeller blade:

(1)Has 1,200 operating hours or more time-in-service

(TIS)and has not reached first overhaul Within 100 operating hours TIS after the effective date of this AD.

(2)Has 1,000 operating hours or more TIS since last overhaul Within 100 operating hours TIS after the effective date of this AD.

(3)Has fewer than 1,200 operating hours TIS Before the propeller blade reaches 1,300 operating hours TIS.

(4)Has been overhauled but has fewer than 1,000 operating hours time-since-overhaul

(TSO)Upon reaching 1,100 operating hours TSO. Propeller Blades Found Cracked

(g)Remove from service propeller blades found with any crack indications. Reporting Requirements

(h)Within 10 calendar days of the inspection, use the Reporting Form for Service Bulletin 252 to report all inspection findings to:

(1)The FAA, Wichita Aircraft Certification Office, 1801 Airport Road, Room 100, Wichita, KS 67209, Attention: Jeff Janusz, telephone

(316)946-4148; FAX

(316)946-4107, e-mail: *jeff.janusz@faa.gov* ; and

(2)McCauley Propeller Systems, 7751 East Pawnee, Wichita, KS 67277.

(3)The Office of Management and Budget

(OMB)has approved the reporting requirements and assigned OMB control number 2120-0056. Alternative Methods of Compliance

(i)The Manager, Wichita Aircraft Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Special Flight Permits

(j)Under 39.23, we are limiting the availability of special flight permits for this AD. Special flight permits are available only if:

(1)The operator has not seen signs of external oil leakage from the hub; and

(2)The operator has not observed abnormal propeller vibration or abnormal engine vibration; and

(3)The operator has not observed any other abnormal operation from the engine or propeller; and

(4)The operator has not made earlier reports of abnormal propeller vibration, abnormal engine vibration, or other abnormal engine or propeller operations, that have not been addressed. Related Information

(k)None. Material Incorporated by Reference

(l)You must use McCauley Propeller Systems Alert Service Bulletin ASB252, dated June 6, 2006, to perform the inspections required by this AD. The Director of the Federal Register approved the incorporation by reference of this service bulletin in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact McCauley Propeller Systems, 7751 East Pawnee, Wichita, KS 67277, for a copy of this service information. You may review copies at the FAA, New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Burlington, Massachusetts, on July 18, 2006. Francis A. Favara, Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E6-11799 Filed 7-25-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 4, 5, and 7 [T.D. TTB-53; Re: Notice No. 62] RIN 1513-AB08 Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Interim rule; Treasury decision. SUMMARY: This interim rule, which parallels the recent amendments to the Federal Food, Drug and Cosmetic Act contained in the Food Allergen Labeling and Consumer Protection Act of 2004, adopts labeling standards for major food allergens used in the production of alcohol beverages subject to the labeling requirements of the Federal Alcohol Administration Act. In addition, elsewhere in this issue of the **Federal Register** , we are publishing a notice of proposed rulemaking that proposes to make major food allergen labeling mandatory. That notice solicits comments from the public, including consumers and affected industry members, on the proposed labeling requirements and the time frame for making the requirements mandatory. Under the interim regulations, producers, bottlers, and importers of wines, distilled spirits, and malt beverages may voluntarily declare the presence of milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as ingredients that contain protein derived from these foods, in their products, but are not required to do so. The interim regulations, however, set forth rules that are mandatory for how industry members must undertake such labeling, should they choose to do so. The regulations also contain procedures for petitioning for an exemption from the standards imposed on those alcohol beverage producers who wish to make voluntary allergen statements on their product labels. DATES: *Effective Date:* This interim rule is effective on July 26, 2006. FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 128, Morganza, MD 20660; telephone

(301)290-1460. SUPPLEMENTARY INFORMATION: I. Background In recent years, the presence of food allergens in foods has become a matter of public concern. In response, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 to require the declaration in labeling of major food allergens in plain, common language on the foods regulated under the Federal Food, Drug and Cosmetic Act. A House of Representatives committee report also noted that the committee expected the Alcohol and Tobacco Tax and Trade Bureau

(TTB)to issue regulations on allergen labeling for alcohol beverage products under TTB's existing authority to regulate alcohol beverage labeling, working in cooperation with the Food and Drug Administration (FDA). In addition, TTB had earlier received a petition concerning ingredient and allergen labeling for alcohol beverages. In response, TTB is issuing these interim regulations regarding voluntary labeling of major food allergens used in the production of alcohol beverage products. TTB also is proposing mandatory major food allergen labeling for alcohol beverage products in a notice of proposed rulemaking published elsewhere in this issue of the **Federal Register** . A. FAA Act TTB is responsible for the administration of the Federal Alcohol Administration Act, 27 U.S.C. 201 *et seq.* , (FAA Act), which governs, among other things, the labeling of wines containing at least 7 percent alcohol by volume, distilled spirits, and malt beverages in interstate and foreign commerce. These products are generically referred to as “alcohol beverages” or “alcohol beverage products” throughout this document. In particular, section 105(e) of the FAA Act (27 U.S.C. 205(e)) gives the Secretary of the Treasury authority to issue regulations regarding the labeling of alcohol beverages to provide the consumer with adequate information concerning the identity and quality of such products, to prevent deception of the consumer, and to prohibit false or misleading statements. Section 105(e) also makes it unlawful for industry members “to sell or ship or deliver for sale or shipment, or otherwise introduce in interstate or foreign commerce, or to receive therein, or to remove from customs custody for consumption, any distilled spirits, wine, or malt beverages in bottles, unless such products are bottled, packaged, and labeled in conformity” with regulations prescribed by the Secretary. Regulations setting forth mandatory labeling information requirements for wine, distilled spirits, and malt beverages are contained, respectively, in parts 4, 5, and 7 of the TTB regulations (27 CFR parts 4, 5, and 7). Most of the mandatory labeling requirements found in parts 4, 5, and 7 flow directly from the stated purpose of section 105(e) of the FAA Act, that is, to “provide the consumer with adequate information as to the identity and quality of the products, the alcoholic content thereof * * *, the net contents of the package, and the manufacturer or bottler or importer of the product.” Currently, the TTB labeling regulations contained in parts 4, 5, and 7 require the following information to appear on alcohol beverage labels: Brand name; product identity (class or type); the name and address of the bottler, packer, or importer; the net contents; and the alcohol content of distilled spirits, certain flavored malt beverage products, and wines over 14 percent alcohol by volume. Labels for wines with 14 percent alcohol by volume or less may contain either an alcohol content statement or the type designation “table” wine or “light” wine (see 27 CFR part 4.36(a)). In addition, labels must note the presence of sulfites, FD&C Yellow No. 5, and in the case of malt beverages, aspartame. A health warning statement applicable to all alcohol beverages containing 0.5 percent or more alcohol by volume is required by the Alcoholic Beverage Labeling Act of 1988, codified at 27 U.S.C. 213-219 and 219a and implemented in the TTB regulations at 27 CFR part 16. B. Current Health-Risk Ingredient Disclosure on Alcohol Beverage Labels Our predecessor agency, the Bureau of Alcohol, Tobacco and Firearms (ATF), proposed on several occasions to adopt mandatory ingredient disclosure requirements for alcohol beverages. In each case, ATF ultimately decided not to adopt full ingredient labeling requirements. (See Notice No. 41, 70 FR 22274, April 29, 2005, for a more complete history of those ingredient labeling regulatory initiatives.) These rulemaking actions included publication of T.D. ATF-150 (48 FR 45549, October 6, 1983), which rescinded the ingredient disclosure regulations that had been published in T.D. ATF-66 (45 FR 40538, June 13, 1980), but never implemented. T.D. ATF-150 did, however, mandate the disclosure of one ingredient, FD&C Yellow No. 5, on alcohol beverage labels. In the preamble to T.D. ATF-150, ATF stated: * * * there is no clear evidence in the record that any other ingredient besides FD&C Yellow No. 5 poses any special health problem. The Department will look at the necessity of mandatory labeling of other ingredients on a case-by-case basis through its own rulemaking initiative, or on the basis of petitions for rulemaking under 5 U.S.C. 553(e) and 27 CFR 71.41(c). In conformity with that case-by-case review policy, ATF subsequently issued regulations requiring the disclosure on labels of sulfites in alcohol beverages (T.D. ATF-236, 51 FR 34706, September 30, 1986), because it was determined that the presence of undeclared sulfites in alcohol beverages posed a recognized health problem to sulfite-sensitive individuals. In 1987, ATF entered into a Memorandum of Understanding

(MOU)with FDA. See 52 FR 45502 (November 30, 1987). In the MOU, ATF made a commitment to consult with FDA regarding the necessity of requiring labeling statements for ingredients in alcohol beverages that pose a recognized public health problem and to initiate rulemaking proceedings to require disclosure of such ingredients where appropriate. The pertinent portion of the MOU states: ATF will be responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, wine, and malt beverages pursuant to the FAA Act. When FDA has determined that the presence of an ingredient in food products, including alcoholic beverages, poses a recognized public health problem, and that the ingredient or substance must be identified on a food product label, ATF will initiate rulemaking proceedings to promulgate labeling regulations for alcoholic beverages consistent with ATF's health policy with respect to alcoholic beverages. ATF and FDA will consult on a regular basis concerning the propriety of promulgating regulations concerning the labeling of other ingredients and substances for alcoholic beverages. Pursuant to the policies set forth in the MOU, ATF subsequently issued regulations requiring a declaration on labels when aspartame is used in the production of malt beverages (T.D. ATF-347, 58 FR 44131, August 19, 1993). It should be noted that FD&C Yellow No. 5, sulfites, and aspartame are not considered food allergens because they do not cause IgE (Immunoglobulin E)-mediated responses, but they may cause health problems in certain individuals. C. Petition From Dr. Christine Rogers On April 10, 2004, Christine A. Rogers, PhD., a senior research scientist in the Exposure, Epidemiology and Risk Program at the Harvard School of Public Health, petitioned TTB to change the regulations to require labeling of all ingredients and substances used in the production of alcohol beverages. Dr. Rogers stated that she is allergic to egg protein and that she has had allergic reactions to egg in wine. For that reason, she expressed particular concern with the labeling of allergenic substances in alcohol beverage products. Dr. Rogers noted that allergic symptoms in consumers can include tingling or itching in the mouth, salivation, swelling of tissues, hives, abdominal cramps, vomiting, diarrhea, rapid loss of blood pressure, and death. She explained that allergic reactions to food vary based upon an individual's sensitivity to a particular allergen. The most sensitive allergic individuals are required to carry epinephrine with them for emergency use in the case of exposure to an offending allergen. D. Enactment of FALCPA On August 2, 2004, the President signed into law the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (see title II of Pub. L. 108-282, 118 Stat. 905). FALCPA amends portions of the Federal Food, Drug and Cosmetic Act (FD&C Act, 21 U.S.C. 301, *et seq.* ) to require a food that is, or contains an ingredient that bears or contains, a major food allergen to list this information on its label using plain, common language. For example, instead of merely listing “semolina,” the label must also list “wheat”, and instead of merely listing “sodium casein,” the label must also list “milk.” The FALCPA amendments define “major food allergens” as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as most ingredients containing proteins derived from these foods. The effect of the FALCPA amendments is to add additional allergen information to the food label. The FALCPA amendments provide two ways for a manufacturer to disclose major food allergens on the label: • The label can show the name of the food source from which the major food allergen is derived within parentheses in the ingredient list, for example, “Ingredients: Water, wheat, whey (milk), albumen (eggs), and peanuts”; or • The label can list the name of the food source from which the allergen is derived in summary form after, or adjacent to, an ingredient list, for example: “Ingredients: Water, sugar, whey, and albumen. Contains: Milk and egg.” Section 202 of FALCPA contains a number of congressional findings regarding the health risk posed by allergens. Congress found that approximately 2 percent of adults and 5 percent of infants and young children in the United States suffer from food allergies. Each year, roughly 30,000 individuals require emergency room treatment and 150 individuals die because of allergic reactions to food. Congress found that the eight foods or food groups identified in FALCPA account for 90 percent of all food allergies. Since there is currently no cure for food allergies, a food-allergic consumer must avoid the food to which he or she is allergic. Congress further found that many consumers may not realize that a labeled food ingredient is derived from, or contains, a major food allergen. The FALCPA amendments fill this gap by ensuring that the food source from which a major food allergen is derived is clearly labeled in plain language. FALCPA amends food labeling requirements in the FD&C Act. Pursuant to authority delegated to it by the Secretary of Health and Human Services, FDA is responsible for promoting and protecting the public health through enforcement of the FD&C Act and for ensuring that the nation's food supply is properly labeled. However, it is TTB's responsibility to issue regulations with respect to the labeling of wine, distilled spirits, and malt beverages under the FAA Act. See the 1987 ATF-FDA MOU and *Brown-Forman Distillers Corp.* v. *Mathews,* 435 F. Supp. 5 (W.D. Ky. 1976). The allergen labeling requirements in FALCPA apply to any food, as that term is defined in section 201(f) of the FD&C Act, other than raw agricultural commodities. As reflected in the 1987 MOU with FDA, TTB is responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, wines, and malt beverages pursuant to the FAA Act. The House of Representatives Committee on Energy and Commerce called for TTB to work with FDA to promulgate appropriate allergen labeling regulations for alcohol beverages labeled under the FAA Act and TTB regulations, consistent with the 1987 MOU with FDA. The committee report accompanying FALCPA stated: The Committee expects, consistent with the November 30, 1987 Memorandum of Understanding, that the Alcohol and Tobacco Tax and Trade Bureau

(TTB)of the Department of Treasury will pursuant to the Federal Alcohol Administration Act determine how, as appropriate, to apply allergen labeling of beverage alcohol products and the labeling requirements for those products. The Committee expects that the TTB and the FDA will work together in promulgation of allergen regulations, with respect to those products. (H.R. Rep. No. 608, 108th Cong., 2d Sess., at 3 (2004); hereafter “House committee report.”) Congress thus recognized TTB's longstanding policy of consulting with FDA in determining what ingredients in alcohol beverages should be disclosed on labels, and called on TTB to work with FDA to promulgate appropriate allergen labeling regulations for alcohol beverages. The clear intent reflected in the House committee report is that TTB issue regulations similar to the FALCPA standards, pursuant to the policies expressed in the MOU with FDA and the authority of the FAA Act. Under the MOU, the two agencies have over the years collaborated on many food safety issues and continue to exchange a wide variety of information, including relevant consumer complaints concerning the adulteration of alcohol beverages. The agencies consult regularly concerning the use and labeling of potentially harmful ingredients and substances in alcohol beverages. The laboratories of FDA and TTB regularly exchange information concerning methodologies and techniques for testing alcohol beverages. Consistent with the expectations expressed in the House committee report, TTB consulted with FDA prior to issuing this interim rule. However, it should be emphasized that while this interim rule is promulgated in response to, among other things, the expectations set out in the legislative history of FALCPA, TTB's legal authority to establish this rule is based on the FAA Act. FDA is the agency authorized to implement FALCPA with regard to foods. The House committee has set forth its expectation that TTB will implement allergen labeling for alcohol beverages, as appropriate, and will work with FDA in this effort. While TTB has generally strived to be consistent with FDA's interpretation of FALCPA, the implementation of regulations regarding major food allergen labeling for alcohol beverages under the FAA Act will necessarily differ in some respects from the requirements of FALCPA. Accordingly, this interim rule reflects TTB's interpretation of its authority under the FAA Act, as guided by the language in the committee report. This regulation does not necessarily represent the views of FDA with regard to allergen labeling or the requirements of FALCPA. II. Rulemaking History and Summary of Comments On April 29, 2005, TTB published in the **Federal Register** (70 FR 22274) Notice No. 41, an advance notice of proposed rulemaking (the ANPRM). The notice was entitled “Labeling and Advertising of Wines, Distilled Spirits and Malt Beverages; Request for Public Comment.” We provided a 60-day period for comments from consumers, interest groups, trade associations, industry, and other members of the public on several alcohol beverage labeling issues, including calorie and carbohydrate claims on labels, “serving facts” labeling, “alcohol facts” labeling, ingredient labeling, allergen labeling, and composite label approaches. In the ANPRM, we invited comments on specific issues related to allergen labeling, including: Whether our regulations should require allergen labeling to be part of or adjacent to a list of ingredients, similar to the FALCPA requirements; whether an allergen must be labeled in an allergen statement even when the allergen name already appears in the product name; how processing or fining agents should be labeled; whether we should consider threshold levels in allergen labeling; what costs industry may incur from new labeling requirements; and how consumers might benefit from allergen labeling. We also invited submission of any other relevant information on the subject of allergen labeling. During the 60-day comment period, we received several requests from alcohol beverage industry representatives and organizations to extend the comment period for an additional 60 to 90 days beyond the original June 28, 2005, closing date. In support of the extension requests, industry members noted that some of the questions posed in the notice were broad and far reaching from a policy standpoint while others were very technical, requiring research and coordination within the affected industries. In response to these requests, we extended the comment period for an additional 90 days. See Notice No. 48, 70 FR 36359, June 23, 2005. The extended comment period for the ANPRM closed on September 26, 2005. We received more than 18,000 comments in response to the ANPRM, approximately 50 of which specifically addressed the subject of allergen labeling. Based on the clearly expressed congressional interest in allergen labeling, the particular risks that allergens pose to human health, FALCPA's effective date of January 1, 2006, and the relatively small number of comments submitted on allergen issues, we have decided to separate the allergen labeling rulemaking from the other issues discussed in the ANPRM. We will review the comments submitted on the other ANPRM issues, with a view to determining whether to proceed with future rulemaking action in those areas, separately from our action on allergen labeling. Accordingly, this document only addresses allergen issues, including the approximately 50 comments on allergens submitted in response to the ANPRM. We note that of the comments we received on allergens, the vast majority favored mandatory labeling of the major food allergens. Industry members as well as consumer and public health advocates commented in support of major food allergen labeling. The major trade associations representing the alcohol beverage industry expressed their support for mandatory labeling of major food allergens. The Beer Institute, the Brewers Association, the Distilled Spirits Council of the United States (DISCUS), the National Association of Beverage Importers (NABI), the Presidents' Forum, Spirits Canada, Wine America, and the Wine Institute submitted a consolidated comment, in which they stated that they fully supported the purpose and objectives of FALCPA and stood ready to work with TTB in the implementation of allergen labeling. In a separate comment, the Brewers Association stated that “mandatory rules regarding the disclosure of major allergens are necessary because certain types of allergens, or at least when present above scientifically determined harmful levels, can pose a significant threat to consumer health.” Consumer and public health interest groups also submitted comments in support of mandatory labeling of major food allergens. The National Consumers League

(NCL)submitted a comment supported by several groups, including the American Public Health Association and the American School Health Association. This comment urged TTB to adopt a uniform, mandatory labeling regime for all alcohol beverages that includes, among other things, an ingredient declaration listing each ingredient by its common or usual name and identifying any major food allergens present in the product. The Center for Science in the Public Interest (CSPI), a nonprofit health education and advocacy organization, submitted a comment in support of the adoption of a mandatory allergen disclosure policy for alcohol beverages consistent with the FALCPA requirements for food and the FDA policies implementing FALCPA. We also received comments in support of allergen labeling from the American Medical Association; the American Academy of Allergy, Asthma and Immunology; the American College of Allergy, Asthma and Immunology; the Food Allergy and Anaphylaxis Network; the American Council on Science and Health; the American Society of Addiction Medicine; the American Dietetic Association; the American Nurses Association; Shape Up America; and several other public health organizations and health professionals. Only a few comments questioned the usefulness of requiring allergen information on alcohol beverage labels. Furthermore, there were some disagreements among the commenters about the allergen labeling implementation issues that we raised in the ANPRM. III. Interim Regulatory Changes After careful consideration of the comments on this issue, TTB has determined that it should propose rules for the mandatory labeling of major food allergens used in the production of alcohol beverages. Consistent with the guidance expressed in the House committee report and our statutory mandate under the FAA Act to promulgate regulations ensuring that consumers receive adequate information about the identity and quality of alcohol beverages, we believe that alcohol beverage labels should provide consumers with sufficient information about the use of major food allergens in the production of alcohol beverages so that allergic consumers may make an informed decision as to whether consumption of a particular beverage may pose a risk of an allergic reaction. Accordingly, we are proposing mandatory labeling of major food allergens elsewhere in this issue of the **Federal Register.** As explained below, we are issuing this interim rule to provide immediate guidance to industry members who wish to place allergen statements on alcohol beverage labels on a voluntary basis. The interim regulations also allow for the immediate filing of petitions for exemptions from the standards imposed on those producers who wish to make voluntary allergen statements on their labels. A. Voluntary Labeling Approach We note that in response to the ANPRM, some commenters urged TTB to require labeling of major food allergens for products labeled on or after January 1, 2006, which is the effective date of the FALCPA amendments. One commenter suggested that consumers will expect to see allergen information on alcohol beverage products at the same time that such information begins appearing on food labels under FALCPA, and that they may be misled by the absence of such information on labels of products that in fact contain major food allergens. Other commenters, recognizing that it may take some time before a final rule is issued, suggested that TTB allow voluntary labeling of major food allergens pending the completion of rulemaking. In this regard, it should be noted that the congressional committees involved with FALCPA had different expectations of FDA and of TTB. The report of the Senate Committee on Health, Education, Labor, and Pensions, S. Rep. No. 226, 108th Cong., 2d Sess., at 10

(2004)(hereafter “Senate committee report”), states: The committee intends the requirements of section 403(w) to be self-implementing. FDA will not be required to issue regulations to implement section 403(w). FDA may issue guidance, should the agency find that guidance would assist manufacturers or distributors, particularly small businesses, to comply with the requirements in this legislation. On the other hand, as previously noted, the House committee report specifically stated its expectation that TTB would promulgate regulations, in consultation with FDA, to apply allergen labeling requirements to alcohol beverages, as appropriate. Given that the TTB regulations must be amended in order to implement allergen labeling, we believe it is appropriate to allow the public, including affected industry members, the opportunity to comment on allergen labeling standards before making them mandatory. Accordingly, in order to make allergen labeling standards applicable to alcohol beverages at the earliest practicable date, and before the public comment procedures can be completed, TTB has determined that the best approach is to adopt voluntary regulatory standards for major food allergen labeling through an interim rule. TTB agrees with those commenters who suggested that producers of alcohol beverages be given immediate guidance with respect to the voluntary use of allergen labeling statements on labels. We have already received inquiries from industry members about the voluntary use of allergen statements on alcohol beverage labels. Because industry members may wish to begin providing allergen information to consumers on a voluntary basis right away, we are publishing standards that are effective immediately. The interim rule also gives industry members an opportunity to file petitions for exemption from the standards imposed on those alcohol beverage producers who wish to make voluntary allergen statements on their product labels. This interim rule amends parts 4, 5, and 7 of the TTB regulations to include specific requirements for those who choose to place voluntary declarations of major food allergens on labels. The amendments include the addition of new sections 4.32a, 5.32a, and 7.22a, which set forth specific format requirements for the voluntary labeling of major food allergens. In addition, we have added new sections 4.32b, 5.32b, and 7.22b, which allow any person to petition TTB for an exemption from the labeling standards that apply if voluntary major food allergen labeling is undertaken. A detailed discussion of the specific provisions within the interim regulations follows. In consideration of the requirements for prior public notice and comment procedures under the Administrative Procedure Act, we are proposing the adoption of mandatory labeling standards in a separate document, Notice No. 62, which is published in the Proposed Rules section of this issue of the **Federal Register.** The voluntary standards adopted in this interim rule document will remain in place until they are replaced by final action on the proposal for mandatory standards. B. Labeling of Major Food Allergens 1. Definitions Consistent with the FALCPA amendments, the interim regulations provide that when allergen labeling is undertaken, the product must be labeled “Contains:” followed by the name of the food source from which each major food allergen is derived, as set forth in the definition of “major food allergen.” The definition of the term “major food allergen” is consistent with the statutory definition in FALCPA. The interim regulations define the term “major food allergen” as any of the following: “Milk, egg, fish (for example, bass, flounder, or cod), Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts (for example, almonds, pecans, or walnuts), wheat, peanuts, and soybeans.” The term as defined also includes any food ingredient that contains protein derived from one of these eight foods or food groups, subject to certain exceptions explained below. It should be noted that, consistent with guidance provided by FDA to the food industry, the interim regulations allow the terms “soybean,” “soy,” and “soya” as synonyms for the term “soybeans,” as used in the statute. Furthermore, also consistent with FDA guidance, the singular term “peanut” may be substituted for the plural term “peanuts,” and singular terms (for example, almond, pecan, or walnut) may be used in place of plural terms to describe the different types of tree nuts. 2. Labeling of Fish Species FALCPA provides that in the case of tree nuts, the label must list the name of the specific type of nut (for example, almonds, pecans, or walnuts). In the case of Crustacean shellfish, the label must list the name of the species of shellfish (for example, crab, lobster, or shrimp). Finally, in the case of fish, the FALCPA amendments provide that the name of the species of fish (for example, bass, flounder, or cod) must appear on the label. The interim regulations are consistent with the FALCPA amendments with respect to the labeling of tree nuts and Crustacean shellfish. However, for the reasons explained below, the interim regulations set forth in this document do not require labeling of the specific fish species when an industry member chooses to provide major food allergen information. The regulations instead require simply listing “fish” when any type of finfish protein is used in the production of an alcohol beverage. Isinglass and fish gelatin are often used to clarify wines and beers. Isinglass is a substance obtained from the swim bladders of sturgeon and other fish. Fish gelatin is obtained from the skin of a fish. Fish gelatin most often is made from cod skins but can be made from any species of fish. Vintners and brewers, when purchasing isinglass or fish gelatin from a manufacturer for fining purposes, often do not know, and have no way of easily finding out, which particular species of fish was used to make the product. Moreover, it may be difficult for industry members to determine by chemical analysis which particular fish species was the source of the isinglass or fish gelatin. On August 1, 2005, the Flavor and Extract Manufacturers Association of the United States

(FEMA)submitted a request to FDA for guidance concerning the labeling of fish species under the FALCPA amendments. In its request for guidance, FEMA asked FDA to allow for use of the term “fish” for labeling “non-nutritive fish ingredients” used in flavors. FEMA cited clinical and scientific evidence in support of its argument that many fish-allergic individuals will react adversely to more than one species of fish. TTB recognizes that FALCPA requires the labeling of the particular species of fish used as an ingredient in a food product. However, it is our responsibility to implement allergen labeling regulations that are appropriate for alcohol beverages. It is likely that declarations of the use of fish in the production of alcohol beverages will generally involve the use of isinglass or fish gelatin as a processing aid. Because of the particular difficulty faced by the producer in determining the specific species of fish used in producing the isinglass or fish gelatin, and because at least some consumers may be allergic to more than one species of fish, TTB is persuaded that requiring labeling with the name of the specific type of fish would impose a difficult fact-finding burden on the alcohol beverage industry without offering consumers who may be allergic to more than one species of fish any significant additional information to help them avoid the risk of an allergic reaction. Accordingly, we believe that the goal of the FALCPA amendments with respect to alcohol beverages is adequately met if alcohol beverages produced using finfish protein are labeled merely with “fish,” rather than with the name of the fish species. We would note that the data on this matter are not conclusive, and we are specifically inviting comments on this issue in our notice of proposed rulemaking. However, for purposes of the guidance provided in this interim rule for industry members who wish to make voluntary allergen labeling statements, we believe that there is a basis for concluding that a reference to “fish” on the label will provide adequate information to consumers about the presence of finfish protein in certain alcohol beverages. 3. Processing and Fining Agents FALCPA amends the FD&C Act to require that, notwithstanding any other provision of law, a flavoring, coloring, or incidental additive that is or bears or contains a major food allergen must conform to FALCPA's labeling requirements. See 21 U.S.C. 343(w)(4). The FDA regulations define the term “incidental additive” to include, among other things, processing aids. See 21 CFR 101.100(a)(3). Therefore, if alcohol beverage industry members choose to make major food allergen declarations, the interim regulations treat major food allergens used as fining or processing agents in the same way as any other major food allergen used in the production of the alcohol beverage. 4. Threshold Levels The FALCPA amendments, which took effect for foods labeled on or after January 1, 2006, require allergen labeling for foods regulated by FDA without the establishment of any threshold levels for labeling. Furthermore, pursuant to our authority under the FAA Act to ensure that labels provide consumers with adequate information about the identity and quality of alcohol beverage products, the interim regulations provide that if an industry member chooses to label for any major food allergen, all major food allergens and proteins derived from the major food allergens used in production must be declared on the beverage label, unless the product or class of products is covered by an approved petition for exemption. Accordingly, TTB is not setting thresholds in this interim regulation. TTB believes that this position will ensure that consumers have adequate information about the potential presence of even trace amounts of major food allergens in alcohol beverage products. As more accurate scientific data become available in the future, we may revisit the threshold issue as appropriate. C. Exceptions From Allergen Labeling Requirements The interim regulations contain three exceptions from major food allergen labeling. Two of these exceptions are provided within the definition of “major food allergen,” and the third is an exemption through a TTB petition process. 1. Highly Refined Oil The FALCPA amendments exclude from the definition of “major food allergen” any highly refined oil derived from one of the eight foods or food groups listed in that definition and any ingredient derived from such highly refined oil. The Senate committee report at page 7 indicates that the exception for highly refined oils was intended to apply to refined, bleached, deodorized

(RBD)oils. Both the House committee report at page 16 and the Senate committee report at page 7 specifically identify peanut oil as one of the highly refined oils covered by the exception. We believe this exception from labeling for highly refined oils is also appropriate in the case of alcohol beverages, and we therefore have included this as an exception from the definition of a major food allergen in the interim regulatory texts. 2. Exemptions Under the FD&C Act FALCPA added two processes to the FD&C Act at 21 U.S.C. 343(w)(6) and

(7)by which any person may obtain an exemption from the allergen labeling requirements imposed by the statute. Subsection (w)(6) allows any person to petition the Secretary of Health and Human Services to exempt a food ingredient from the allergen labeling requirements. Under its delegated authority, FDA performs the function of the Secretary in this area. In this situation, the burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health. FDA must approve or deny any such petition within 180 days of receipt or the petition will be deemed denied, unless an extension is mutually agreed upon by FDA and the petitioner. Subsection (w)(7) allows any person to file a notification containing scientific evidence demonstrating that an ingredient “does not contain allergenic protein.” The scientific evidence must include the analytical method used to produce the evidence that the ingredient, as derived by the method specified in the notification, does not contain allergenic protein. Alternatively, the notification may contain a determination from FDA under a premarket approval or notification program provided for in section 409 of the FD&C Act (21 U.S.C. 348) that the ingredient does not cause an allergic response that poses a risk to human health. FDA has 90 days to object to a notification. Absent an objection, the food ingredient is exempt from the FDA labeling requirements for major food allergens. Many ingredients and food additives used in the production of foods regulated by FDA are also used in the production of alcohol beverages regulated by TTB. Under the two exemption processes described above, certain ingredients and food additives may be exempted from the allergen labeling requirements of the FD&C Act. We believe it is appropriate to allow alcohol beverage industry members to rely on the exemptions from major food allergen labeling requirements allowed under the FD&C Act and FDA procedures. We have therefore included in the definition of “major food allergen” an exception for uses of food ingredients that are exempt pursuant to 21 U.S.C. 343(w)(6) or (7). It is important to note in this regard that alcohol beverage industry members must consider two issues when determining whether an ingredient exempted under the FD&C Act is also not subject to TTB allergen labeling requirements. First, the ingredient they used or intend to use in a product must be the same ingredient that is exempt under the FD&C Act. Second, the proposed use must be consistent with any conditions of use in the FD&C Act exemption for the ingredient. 3. Petitions for Exemption From TTB Regulations We also recognize that major food allergens are used in alcohol beverage production in ways that may differ from the way they are used in the production of foods regulated by FDA. For this reason, new sections 4.32a, 5.32a, and 7.22a refer in each case to an exception for a product covered by a petition for exemption approved under new section 4.32b, 5.32b, or 7.22b. A petition may pertain to the use of a major food allergen in the production of one specific alcohol beverage product or it may pertain to a class of products using a particular process involving a major food allergen. As stated above, TTB's jurisdiction extends to the labeling of wines, distilled spirits, and malt beverages. Accordingly, we only will accept a petition seeking an exemption from the labeling of a major food allergen when the material in question is used in the production of an alcohol beverage product regulated by TTB. If an exemption from the FD&C Act allergen labeling requirements is also desired, the interested party must submit a petition or notification to FDA under 21 U.S.C. 343(w)(6) or (7), rather than submit a petition under the applicable TTB regulation. The use of the TTB petition process is similar to that of the petition and notification processes provided for at 21 U.S.C. 343(w)(6) and (7), except that the TTB petition procedure focuses on products instead of ingredients. The TTB petition process may be used: • When it is asserted that the product or class of products, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health; or • When it is asserted that the product or class of products, as derived by the method specified in the petition, does not contain allergenic protein, even though a major food allergen was used in production. The interim TTB regulations provide for only a petition procedure, rather than both the petition procedure and the notification procedure provided for in the FALCPA amendments to the FD&C Act. We believe that having one petition procedure, rather than separate petition and notification procedures, will simplify the process for industry, and will allow our personnel adequate time to review the evidence presented in each request for an exemption. TTB is not in a position to administer a 90-day notice procedure similar to the notification procedure in subsection (w)(7) of the statute. The interim regulation petition procedure is therefore similar to the petition procedure in subsection (w)(6) of the statute in that the regulation places the burden on the petitioner to provide evidence in support of the exemption and gives TTB 180 days to respond. The interim regulations provide that a petition for exemption from major food allergen labeling must be submitted to the appropriate TTB officer. The appropriate TTB officer to whom petitions must be submitted is the Assistant Administrator, Headquarters Operations. The petition should be sent to the Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Suite 200E, Washington, DC 20220 and should bear the notation: “Attention: Petition for Exemption from Major Food Allergen Labeling” to ensure prompt processing. In addition, the interim regulations provide that if TTB does not approve or deny the petition for exemption within 180 days of receipt, the petition is deemed denied, unless an extension of time is mutually agreed upon by TTB and the petitioner. The regulations also provide that a determination under this section constitutes a final agency action and that even though a petition is deemed denied because no action was taken within the 180-day period, the petitioner may resubmit the petition at any time. A resubmitted petition will be treated as a new petition. As a result of FDA's implementation of FALCPA and our establishment of this interim rule, TTB and FDA will both be regulating allergen labeling, with TTB overseeing labeling for alcohol beverages and FDA the labeling for all other products that are foods under the FD&C Act. As noted, TTB and FDA are parties to an MOU signed in 1987. That MOU provides that FDA and TTB will exchange information generally about appropriate labeling for, and the adulteration of, alcohol beverages, including information about methodologies and techniques for testing such beverages. Consistent with these general MOU provisions and both agencies' recognition that, generally, the regulation of allergen labeling should be consistent for alcohol beverages and all other foods, TTB intends to confer with FDA, as appropriate and as FDA resources permit, on petitions submitted under this interim rule. Consistent with FALCPA, the interim rule places the burden on the petitioner to provide adequate evidence in its initial petition submission to justify an exemption from labeling. TTB may require the subsequent submission of product samples and other additional information in support of a petition; however, unless required by TTB, the submission of samples or additional information by the petitioner after submission of the petition will be treated as the withdrawal of the initial petition and the submission of a new petition. FALCPA provides that FDA shall promptly post to a public site all petitions within 14 days of receipt and shall promptly post the Government's response to each. Our interim regulations are consistent with FALCPA's requirement to make petitions and responses available to the public, but may go beyond the requirements of FALCPA in some respects. The interim regulations provide that petitions submitted to TTB, and TTB's response to those petitions, will be posted to the TTB Web site ( *http://www.ttb.gov* ). However, TTB will not post lengthy materials submitted in support of a petition on its Web site; we will, instead, make such materials available to the public in accordance with the procedures set forth in the Freedom of Information Act, 5 U.S.C. 552. A person who provides trade secrets or other confidential commercial or financial information in either a petition for exemption or in any supporting documentation submitted in connection with such a petition may request that TTB give confidential treatment to that information. The interim regulations set forth the standards for making such a request. A failure to request confidential treatment at the time the information in question is submitted to TTB will constitute a waiver of confidential treatment. IV. Notice of Proposed Rulemaking In the Proposed Rules section of this issue of the **Federal Register** , we have published a notice of proposed rulemaking, Notice No. 62, to solicit public comment on our proposal to impose mandatory allergen labeling requirements on alcohol beverage products. That notice gives the public, including affected industry members, an opportunity to comment on the mandatory labeling of major food allergens, the time required by industry members to incorporate the required changes on their labels, and how to minimize any added compliance costs. V. Regulatory Analysis and Notices A. Executive Order 12866 We have determined that this interim rule is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. B. Regulatory Flexibility Act Because this interim rule was not required to be preceded by a notice of proposed rulemaking, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ) do not apply. C. Paperwork Reduction Act This interim rule includes a new collection of information involving the declaration of major food allergens on an alcohol beverage label and the submission of petitions for exemption from allergen labeling. This collection is voluntary. The collection of information has been reviewed and, pending receipt and evaluation of public comments, approved by the Office of Management and Budget

(OMB)under 44 U.S.C. 3507(j) and assigned control number 1513-0121. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. The collection of information is contained in §§ 4.32a, 4.32b, 5.32a, 5.32b, 7.22a, and 7.22b. The likely respondents are individuals and business or other for-profit institutions, including partnerships, associations, and corporations. • *Estimated total annual reporting and/or recordkeeping burden:* 730 hours. • *Estimated average annual burden per respondent/recordkeeper:* 1.46 hours. • *Estimated number or respondents and/or recordkeepers:* 500. • *Estimated annual number of responses:* 520. Comments on this collection of information may be sent by e-mail to OMB at *Alexander_T._Hunt@omb.eop.gov* , or by paper mail to Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503. A copy should also be sent to TTB at one of the following addresses: • P.O. Box 14412, Washington, DC 20044-4412; • 202-927-8525 (facsimile); or • *formcomments@ttb.gov* (e-mail). Please reference the information collection's title and OMB number in your comment. If you submit your comment via facsimile, send no more than five 8.5 x 11 inch pages in order to ensure electronic access to our equipment. Comments are invited on the accuracy of the burden. We also invite suggestions on how the burden may be reduced. VI. Inapplicability of Prior Notice and Comment and Delayed Effective Date Procedures It has been determined, pursuant to 5 U.S.C. 553(b)(B) and (d), that good cause exists to issue these regulations without prior notice and public procedure, and without a delayed effective date. Because the industry needs immediate standards for the placement of voluntary statements listing major food allergens on alcohol beverage labels, and because industry members may wish to begin immediately to submit petitions for exemptions, it is impracticable and contrary to the public interest to issue these regulations for prior notice and comment, and with a delayed effective date. VII. Drafting Information The principal author of this document was Jessica M. Bungard, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau. However, other personnel participated in its development. List of Subjects 27 CFR Part 4 Administrative practice and procedure, Advertising, Customs duties and inspection, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements, Trade practices, Wine. 27 CFR Part 5 Administrative practice and procedure, Advertising, Customs duties and inspection, Distilled spirits, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements, Trade practices. 27 CFR Part 7 Administrative practice and procedure, Advertising, Customs duties and inspection, Imports, Labeling, Malt beverages, Reporting and recordkeeping requirements, Trade practices. Amendments to the Regulations For the reasons discussed in the preamble, TTB amends 27 CFR parts 4, 5, and 7 as follows: PART 4—LABELING AND ADVERTISING OF WINE 1. The authority citation for 27 CFR part 4 continues to read as follows: Authority: 27 U.S.C. 205. 2. A new § 4.32a is added to read as follows: § 4.32a Voluntary disclosure of major food allergens.

(a)*Definitions* . For purposes of this section the following terms have the meanings indicated.

(1)*Major food allergen* . *Major food allergen* means any of the following:

(i)Milk, egg, fish (for example, bass, flounder, or cod), Crustacean shellfish (for example, crab, lobster, or shrimp), tree nuts (for example, almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or

(ii)A food ingredient that contains protein derived from a food specified in paragraph (a)(1)(i) of this section, except:

(A)Any highly refined oil derived from a food specified in paragraph (a)(1)(i) of this section and any ingredient derived from such highly refined oil; or

(B)A food ingredient that is exempt from major food allergen labeling requirements pursuant to a petition for exemption approved by the Food and Drug Administration

(FDA)under 21 U.S.C. 343(w)(6) or pursuant to a notice submitted to FDA under 21 U.S.C. 343(w)(7), provided that the food ingredient meets the terms or conditions, if any, specified for that exemption.

(2)*Name of the food source from which each major food allergen is derived. Name of the food source from which each major food allergen is derived* means the name of the food as listed in paragraph (a)(1)(i) of this section, except that:

(i)In the case of a tree nut, it means the name of the specific type of nut (for example, almonds, pecans, or walnuts);

(ii)In the case of Crustacean shellfish, it means the name of the species of Crustacean shellfish (for example, crab, lobster, or shrimp); and

(iii)The names “egg” and “peanuts”, as well as the names of the different types of tree nuts, may be expressed in either the singular or plural form, and the term “soy”, soybean”, or “soya” may be used instead of “soybeans”.

(b)*Voluntary labeling standards* . Major food allergens (defined in paragraph (a)(1) of this section) used in the production of a wine may, on a voluntary basis, be declared on any label affixed to the container. However, if any one major food allergen is voluntarily declared, all major food allergens used in production of the wine, including major food allergens used as fining or processing agents, must be declared, except when covered by a petition for exemption approved by the appropriate TTB officer under § 4.32b. The major food allergens declaration must consist of the word “Contains” followed by a colon and the name of the food source from which each major food allergen is derived (for example, “Contains: egg”).

(c)*Cross reference* . For mandatory labeling requirements applicable to wines containing FD&C Yellow No. 5 and sulfites, see §§ 4.32(c) and (e). 3. A new § 4.32b is added to read as follows: § 4.32b Petitions for exemption from major food allergen labeling.

(a)*Submission of petition* . Any person may petition the appropriate TTB officer to exempt a particular product or class of products from the labeling requirements of § 4.32a. The burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the finished product or class of products, as derived by the method specified in the petition, either:

(1)Does not cause an allergic response that poses a risk to human health; or

(2)Does not contain allergenic protein derived from one of the foods identified in § 4.32a(a)(1)(i), even though a major food allergen was used in production.

(b)*Decision on petition.* TTB will approve or deny a petition for exemption submitted under paragraph

(a)of this section in writing within 180 days of receipt of the petition. If TTB does not provide a written response to the petitioner within that 180-day period, the petition will be deemed denied, unless an extension of time for decision is mutually agreed upon by the appropriate TTB officer and the petitioner. TTB may confer with the Food and Drug Administration

(FDA)on petitions for exemption, as appropriate and as FDA resources permit. TTB may require the submission of product samples and other additional information in support of a petition; however, unless required by TTB, the submission of samples or additional information by the petitioner after submission of the petition will be treated as the withdrawal of the initial petition and the submission of a new petition. An approval or denial under this section will constitute a final agency action.

(c)*Resubmission of a petition.* After a petition for exemption is denied under this section, the petitioner may resubmit the petition along with supporting materials for reconsideration at any time. TTB will treat this submission as a new petition for purposes of the time frames for decision set forth in paragraph

(b)of this section.

(d)*Availability of information.*

(1)*General.* TTB will promptly post to its public Web site, *http://www.ttb.gov,* all petitions received under this section as well as TTB's responses to those petitions. Any information submitted in support of the petition that is not posted to the TTB Web site will be available to the public pursuant to 5 U.S.C. 552, except where a request for confidential treatment is granted under paragraph (d)(2) of this section.

(2)*Requests for confidential treatment of business information.* A person who provides trade secrets or other commercial or financial information in connection with a petition for exemption under this section may request that TTB give confidential treatment to that information. A failure to request confidential treatment at the time the information in question is submitted to TTB will constitute a waiver of confidential treatment. A request for confidential treatment of information under this section must conform to the following standards:

(i)The request must be in writing;

(ii)The request must clearly identify the information to be kept confidential;

(iii)The request must relate to information that constitutes trade secrets or other confidential commercial or financial information regarding the business transactions of an interested person, the disclosure of which would cause substantial harm to the competitive position of that person;

(iv)The request must set forth the reasons why the information should not be disclosed, including the reasons the disclosure of the information would prejudice the competitive position of the interested person; and

(a)*Definitions.* For purposes of this section the following terms have the meanings indicated.

(1)*Major food allergen. Major food allergen* means any of the following:

(ii)A food ingredient that contains protein derived from a food specified in paragraph (a)(1)(i) of this section, except:

(A)Any highly refined oil derived from a food specified in paragraph (a)(1)(i) of this section and any ingredient derived from such highly refined oil; or

(B)A food ingredient that is exempt from major food allergen labeling requirements pursuant to a petition for exemption approved by the Food and Drug Administration

(i)In the case of a tree nut, it means the name of the specific type of nut (for example, almonds, pecans, or walnuts);

(ii)In the case of Crustacean shellfish, it means the name of the species of Crustacean shellfish (for example, crab, lobster, or shrimp); and

(b)*Voluntary labeling standards.* Major food allergens (defined in paragraph (a)(1) of this section) used in the production of a distilled spirit product may, on a voluntary basis, be declared on any label affixed to the container. However, if any one major food allergen is voluntarily declared, all major food allergens used in production of the distilled spirit product, including major food allergens used as fining or processing agents, must be declared, except when covered by a petition for exemption approved by the appropriate TTB officer under § 5.32b. The major food allergens declaration must consist of the word “Contains” followed by a colon and the name of the food source from which each major food allergen is derived (for example, “Contains: egg”).

(c)*Cross reference.* For mandatory labeling requirements applicable to distilled spirits products containing FD&C Yellow No. 5 and sulfites, see §§ 5.32(b)(5) and (7). 3. A new § 5.32b is added to read as follows: § 5.32b Petitions for exemption from major food allergen labeling.

(a)*Submission of petition.* Any person may petition the appropriate TTB officer to exempt a particular product or class of products from the labeling requirements of § 5.32a. The burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the finished product or class of products, as derived by the method specified in the petition, either:

(1)Does not cause an allergic response that poses a risk to human health; or

(2)Does not contain allergenic protein derived from one of the foods identified in § 5.32a(a)(1)(i), even though a major food allergen was used in production.

(b)*Decision on petition.* TTB will approve or deny a petition for exemption submitted under paragraph

(b)of this section.

(d)*Availability of information.*

(i)The request must be in writing;

(ii)The request must clearly identify the information to be kept confidential;

(a)*Definitions.* For purposes of this section the following terms have the meanings indicated.

(1)*Major food allergen.* *Major food allergen* means any of the following:

(ii)A food ingredient that contains protein derived from a food specified in paragraph (a)(1)(i) of this section, except:

(A)Any highly refined oil derived from a food specified in paragraph (a)(1)(i) of this section and any ingredient derived from such highly refined oil; or

(B)A food ingredient that is exempt from major food allergen labeling requirements pursuant to a petition for exemption approved by the Food and Drug Administration

(2)*Name of the food source from which each major food allergen is derived.* *Name of the food source from which each major food allergen is derived* means the name of the food as listed in paragraph (a)(1)(i) of this section, except that:

(i)In the case of a tree nut, it means the name of the specific type of nut (for example, almonds, pecans, or walnuts); and

(ii)In the case of Crustacean shellfish, it means the name of the species of Crustacean shellfish (for example, crab, lobster, or shrimp); and

(iii)The names “egg” and “peanuts”, as well as the names of the different types of tree nuts, may be expressed in either the singular or plural form, and the name “soy”, “soybean”, or “soya” may be used instead of “soybeans”.

(b)*Voluntary labeling standards.* Major food allergens (defined in paragraph (a)(1) of this section) used in the production of a malt beverage product may, on a voluntary basis, be declared on any label affixed to the container. However, if any one major food allergen is voluntarily declared, all major food allergens used in production of the malt beverage product, including major food allergens used as fining or processing agents, must be declared, except when covered by a petition for exemption approved by the appropriate TTB officer under § 7.22b. The major food allergens declaration must consist of the word “Contains” followed by a colon and the name of the food source from which each major food allergen is derived (for example, “Contains: egg”).

(c)*Cross reference.* For mandatory labeling requirements applicable to malt beverage products containing FD&C Yellow No. 5, sulfites, and aspartame, see §§ 7.22(b)(4), (b)(6), and (b)(7). 3. A new § 7.22b is added to read as follows: § 7.22b Petitions for exemption from major food allergen labeling.

(a)*Submission of petition.* Any person may petition the appropriate TTB officer to exempt a particular product or class of products from the labeling requirements of § 7.22a. The burden is on the petitioner to provide scientific evidence (including the analytical method used to produce the evidence) that demonstrates that the finished product or class of products, as derived by the method specified in the petition, either:

(1)Does not cause an allergic response that poses a risk to human health; or

(2)Does not contain allergenic protein derived from one of the foods identified in § 7.22(a)(1)(i), even though a major food allergen was used in production.

(b)*Decision on petition.* TTB will approve or deny a petition for exemption submitted under paragraph

(d)*Availability of information.*

(i)The request must be in writing;

(ii)The request must clearly identify the information to be kept confidential;

(v)The request must be supported by a signed statement by the interested person, or by an authorized officer or employee of that person, certifying that the information in question is a trade secret or other confidential commercial or financial information and that the information is not already in the public domain. Signed: February 16, 2006. John J. Manfreda, Administrator. Approved: March 16, 2006. Timothy E. Skud, Deputy Assistant Secretary (Tax, Trade, and Tariff Policy). [FR Doc. E6-11872 Filed 7-25-06; 8:45 am] BILLING CODE 4810-31-P DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY: Department of the Navy, DOD. ACTION: Final rule. SUMMARY: The Department of the Navy is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has determined that USS GRIDLEY (DDG 101) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply. DATES: *Effective Date:* July 17, 2006. FOR FURTHER INFORMATION CONTACT: Commander Gregg A. Cervi, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave., SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone 202-685-5040. SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS GRIDLEY (DDG 101) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 3(c), pertaining to placement of task lights not less than two meters from the fore and aft centerline of the ship in the athwartship direction. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements. Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions. List of Subjects in 32 CFR Part 706 Marine safety, Navigation (water), and Vessels. For the reasons set forth in the preamble, amend part 706 of title 32 of the Code of Federal Regulations as follows: PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read: Authority: 33 U.S.C. 1605. 2. Table Four, Paragraph 15 of § 706.2 is amended by adding, in numerical order, the following entry for USS GRIDLEY: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Vessel Number Horizontal distance from the fore and aft centerline of the vessel in the athwartship direction * * * * * * * USS GRIDLEY DDG 101 1.86 meters. * * * * * * * 3. Table Four, Paragraph 16 of § 706.2 is amended by adding, in numerical order, the following entry for USS GRIDLEY: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Vessel Number Obstruction angle relative ship's headings * * * * * * * USS GRIDLEY DDG 101 107.25° thru 112.50°. * * * * * * * 4. Table Five of § 706.2 is amended by adding, in numerical order, the following entry for USS GRIDLEY: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table Five Vessel Number Masthead lights not over all other lights and obstructions. Annex I, sec. 2(f) Forward masthead light not in forward quarter of ship. Annex I, sec. 3(a) After mast-head light less than 1/2 ship's length aft of forward masthead light. Annex I, sec. 3(a) Percentage horizontal separation attained * * * * * * * USS GRIDLEY DDG 101 X X X 14.5 * * * * * * * Approved: July 17, 2006. Gregg A. Cervi, Commander, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law). [FR Doc. E6-11917 Filed 7-25-06; 8:45 am] BILLING CODE 3810-FF-P DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY: Department of the Navy, DOD. ACTION: Final rule. SUMMARY: The Department of the Navy is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has determined that USS KIDD (DDG 100) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply. DATES: *Effective Date:* July 14, 2006. FOR FURTHER INFORMATION CONTACT: Commander Gregg A. Cervi, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave., SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone 202-685-5040. SUPPLEMENTARY INFORMATION: Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS KIDD (DDG 100) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 3(c), pertaining to placement of task lights not less than two meters from the fore and aft centerline of the ship in the athwartship direction. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements. Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions. List of Subjects in 32 CFR Part 706 Marine safety, Navigation (water), and Vessels. For the reasons set forth in the preamble, amend part 706 of title 32 of the Code of Federal Regulations as follows: PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read: Authority: 33 U.S.C. 1605. 2. Table Four, Paragraph 15 of § 706.2 is amended by adding, in numerical order, the following entry for USS KIDD: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Vessel Number Horizontal distance from the fore and aft centerline of the vessel in the athwartship direction * * * * * * * USS KIDD DDG 100 1.89 meters. * * * * * * * 3. Table Four, Paragraph 16 of § 706.2 is amended by adding, in numerical order, the following entry for USS KIDD: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Vessel Number Obstruction angle relative ship's headings * * * * * * * USS KIDD DDG 100 107.67° thru 112.50°. * * * * * * * 4. Table Five of § 706.2 is amended by adding, in numerical order, the following entry for USS KIDD: § 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table Five Vessel Number Masthead lights not over all other lights and obstructions. Annex I, sec. 2(f) Forward masthead light not in forward quarter of ship. Annex I, sec. 3(a) After mast-head light less than 1/2 ship's length aft of forward masthead light. Annex I, sec. 3(a) Percentage horizontal separation attained * * * * * * * USS KIDD DDG 100 X X X 14.4 * * * * * * * Approved: July 14, 2006. Gregg A. Cervi, Commander, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law). [FR Doc. E6-11923 Filed 7-25-06; 8:45 am] BILLING CODE 3810-FF-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [CGD13-06-007] RIN 1625-AA08 Special Local Regulation: Annual Dragon Boat Races, Portland, OR AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is establishing a permanent special local regulation for the Dragon Boat Races held annually on the second Saturday and Sunday of June on the waters of the Willamette River, Portland, Oregon. These special local regulations limit the movement of non-participating vessels in the regulated race area. This rule will provide for the safety of life on navigable waters during the event. This rule will also remove special local regulations for the formerly-annual, Clarkston, Washington, Limited Hydroplane Races which no longer occur on a regular basis. DATES: This rule is effective June 10, 2006. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket [CGD13-06-007] and are available for inspection or copying at U.S. Coast Guard Sector Portland between 7 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: MST1 Charity Keuter, c/o Captain of the Port Portland, 6767 N. Basin Ave, Portland, OR 97217-3992, and (503)240-9311 SUPPLEMENTARY INFORMATION: Regulatory Information On March 21, 2006, we published a notice of proposed rulemaking

(NPRM)entitled Special Local Regulation: Annual Dragon Boat Races, Portland, OR in the **Federal Register** (71 FR 14132). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the **Federal Register.** Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, support craft, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. However advance notifications will be made to users of the waterway via marine information broadcasts and area newspapers. Background and Purpose We are revising 33 CFR 100.1302 because the annual Clarkston, Washington, Limited Hydroplane Races are no longer an event which occurs with any regularity. These races have not been conducted for at least 5 years and the sponsor has stated that they are no longer conducted. We are rewriting § 100.1302 for an event, the Dragon Boat Races in Portland, Oregon, that takes place annually and would benefit from a permanent rule. This event may result in a number of recreational vessels congregating near the boat races. The regulated area is needed to protect event participants. Dragon Boats have very little freeboard and are susceptible to swamping. Accordingly, regulatory action is needed in order to provide for the safety of spectators and participants during the event. Discussion of Comments and Changes No comments or letters were received in response to the NPRM. Therefore, we made no changes from the proposed rule except to add a definition of the “race area” to clarify where it was located within the regulated area. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the fact that the regulated area established by the regulation will encompass a small portion of the river for eighteen hours over two days. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. This regulated area will not have significant economic impact on a substantial number of small entities for the following reasons: This rule will be enforced for only 18 hours annually and vessel traffic will be allowed to safely pass around the race area and through the remainder of the regulated area with a “no wake” zone enforced. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Petty Officer Charity Keuter at

(503)240-9301. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). Collection of Information This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. No comments were received. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969

(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. List of Subjects in 33 CFR Part 100 Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233; Department of Homeland Security Delegation No. 0170.1. 2. Revise § 100.1302 to read as follows: § 100.1302 Special Local Regulation, Annual Dragon Boat Races, Portland, Oregon.

(a)*Regulated area.* All waters of the Willamette River shore to shore, bordered on the north by the Hawthorne Bridge, and on the south by the Marquam Bridge.

(b)*Definition.* For purposes of this section, *race area* means an area 536-meters-long by 80-feet-wide designated by buoys and floatation line markers within the regulated area described in paragraph

(a)of this section. The buoys have 4-foot poles attached to them. Two of the buoys are red, one is white, and the other is yellow. The course runs from the north side of the Hawthorne bridge south along the east bank to the east most pier of the Markham bridge and from the south side of the Markham bridge to the east pier of the center span. The center span is left open to allow commercial traffic through during the event. The course then continues from the west Pier of the center span and to the first pier west on the south side of the piers and continues north and ends at River Place dock.

(c)*Enforcement period.* The event is a two-day event which will be enforced from 8 a.m.

(PDT)to 5 p.m.

(PDT)on the second Saturday and Sunday of June each year. In 2006, this section will be enforced from 8 a.m. until 5 p.m. on Saturday, June 10, and Sunday, June 11.

(d)*Special local regulation.*

(1)Non-participant vessels are prohibited from entering the race area unless authorized by the Coast Guard Patrol Commander.

(2)All persons or vessels not registered with the sponsor as participants or not part of the regatta patrol are considered spectators. Spectator vessels must be moored to a waterfront facility in a way that will not interfere with the progress of the event or have permission to enter the area from the event sponsor or Coast Guard patrol commander. Spectators must proceed at a safe speed as not to cause a wake. This requirement will be strictly enforced to preserve the safety of both life and property.

(3)A succession of sharp, short signals by whistle or horn from vessels patrolling the area under the direction of the Patrol Commander shall serve as a signal to stop. Vessels signaled shall stop and shall comply with the orders of the patrol vessel. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.

(4)The Coast Guard Patrol Commander may be assisted by other Federal, State and local law enforcement agencies in enforcing this regulation. Dated: May 30, 2006. R.R. Houck, Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard District. [FR Doc. E6-11876 Filed 7-25-06; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0552; FRL-8075-8] Butene, Homopolymer; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation revises the exemption from the requirement of a tolerance for residues of butene, homopolymer when used as an inert ingredient in a pesticide chemical formulation. Miller Chemical and Fertilizer Corporatation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting a revision of an exemption (which has already been established) from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of butene, homopolymer. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION . ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0552. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-8380; e-mail address: *gandhi.bipin@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111) • Animal production (NAICS code 112) • Food manufacturing (NAICS code 311) • Pesticide manufacturing (NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0552 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0552, by one of the following methods. • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of January 25, 2006 (71 FR 4138) (FRL-7744-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 5E6958) by Miller Chemical and Fertilizer Corporation, P. O. Box 333, 120 Radio Road, Hanover, PA 17331. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of butene, homopolymer; CAS Reg.No. 9003-29-6. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, butene, homopolymer, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, butene, homopolymer, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer's number average molecular weight

(MW)of 1100 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, butene, homopolymer meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to butene, homopolymer. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that butene, homopolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of butene, homopolymer is 1100 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since butene, homopolymer conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether butene, homopolymer has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to butene, homopolymer and any other substances and butene, homopolymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that butene, homopolymer has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of butene, homopolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of butene, homopolymer. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that butene, homopolymer is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for butene, homopolymer nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of butene, homopolymer from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 10, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960 the table is amended by revising the entry for “Butene, homopolymer minimum number average molecular weight (in amu), 1,330” to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. * * * * * Butene, homopolymer 9003-29-6 * * * * * [FR Doc. E6-11720 Filed 7-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0555; FRL-8077-4] 2-Propenoic Acid, 2-Methyl-, Polymer with Butyl 2-Propenoate, Methyl 2-Methyl-2-Propenoate, Methyl 2-Propenoate and 2-Propenoic Acid, Graft, Compound with 2-Amino-2-Methyl-1-Propanol; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol when used as an inert ingredient in a pesticide chemical formulation. E. I. du Pont de Nemours and Company, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl -1-propanol. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0555. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)308-8380; e-mail address: *gandhi.bipin@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111) • Animal production (NAICS code 112) • Food manufacturing (NAICS code 311) • Pesticide manufacturing (NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0555 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0555, by one of the following methods. • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 19, 2006 (71 FR 20098) (FRL-8065-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7032) by E. I. du Pont de Nemours and Company, Inc., 1007 Market St., Wilmington, DE 19898. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol; CAS Reg. No. 153163-36-1. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, does contain as an integral part of its composition the atomic elements carbon, hydrogen, nitrogen and oxygen. 3. The polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The number average molecular weight of the polymer, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, is 7,080 which is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The numerical average MW of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2- amino-2-methyl-1-propanol is 7,080 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol and any other substances and 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate and 2-propenoic acid, graft, compound with 2-amino-2-methyl-1-propanol from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 17, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960 the table is amended by adding alphabetically a polymer to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. * * * * * 2-Propenoic acid, 2-Methyl-, Polymer with Butyl 2-Propenoate, Methyl 2-Methyl-2-Propenoate, Methyl 2-Propenoate and 2-Propenoic Acid, graft, Compound with 2-Amino-2-Methyl-1-Propanol CAS Reg. No.153163-36-1 * * * * * [FR Doc. E6-11807 Filed 7-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0550; FRL-8078-3] 2-Propenoic, 2-Methyl-, Polymers with Ethyl Acrylate and Polyethylene Glycol Methylacrylate C 18-22 Alkyl Ethers; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers (CAS No. 888969-14-0) when used as an inert ingredient in a pesticide chemical formulation. The Lubrizol Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0550. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)308-8380; e-mail address: *gandhi.bipin@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0550 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0550, by one of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of January 25, 2006 (71 FR 4137) (FRL-7749-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 5E6990) by The Lubrizol Corporation, 29400 Lakeland Blvd., Wickliffe, OH 44092. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers; CAS No. 888969-14-0. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The number average molecular weight

(MW)of the polymer, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers is 94,600, which is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers is 94,600 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers and any other substances and 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 17, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.960, the table is amended by adding alphabetically a polymer to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. * * * * * 2-Propenoic, 2-methyl-, polymers with ethyl acrylate and polyethylene glycol methylacrylate C 18-22 alkyl ethers 888969-14-0 * * * * * [FR Doc. E6-11824 Filed 7-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0588; FRL-8078-4] Oxirane, Methyl-, Polymer with Oxirane, Monobutyl Ether; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of oxirane, methyl-, polymer with oxirane, monobutyl ether; when used as an inert ingredient in a pesticide chemical formulation. BASF Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of oxirane, methyl-, polymer with oxirane, monobutyl ether. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0588. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)308-8380; e-mail address: *gandhi.bipin@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111) • Animal production (NAICS code 112) • Food manufacturing (NAICS code 311) • Pesticide manufacturing (NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0588 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0588, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of June 1, 2005 (70 FR 31453) (FRL-7711-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 5E6917) by BASF Corporation, 100 Campus Drive, Florham Park, NJ 07932. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of oxirane, methyl-, polymer with oxirane, monobutyl ether; CAS Reg. No. 9038-95-3. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, oxirane, methyl-, polymer with oxirane, monobutyl ether, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer's number average MW of 4,000 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, oxirane, methyl-, polymer with oxirane, monobutyl ether meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to oxirane, methyl-, polymer with oxirane, monobutyl ether. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, methyl-, polymer with oxirane, monobutyl ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of oxirane, methyl-, polymer with oxirane, monobutyl ether is 4,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since oxirane, methyl-, polymer with oxirane, monobutyl ether conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether oxirane, methyl-, polymer with oxirane, monobutyl ether has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to oxirane, methyl-, polymer with oxirane, monobutyl ether and any other substances and oxirane, methyl-, polymer with oxirane, monobutyl ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that oxirane, methyl-, polymer with oxirane, monobutyl ether has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of oxirane, methyl-, polymer with oxirane, monobutyl ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of oxirane, methyl-, polymer with oxirane, monobutyl ether. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that oxirane, methyl-, polymer with oxirane, monobutyl ether is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for oxirane, methyl-, polymer with oxirane, monobutyl ether nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of oxirane, methyl-, polymer with oxirane, monobutyl ether from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. ” “Policies that have federalism implications ” is defined in the Executive order to include regulations 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule ” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 17, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.960 is amended in the table by removing the entry for “α-Butyl-ω-hydroxypoly(oxypropylene) block polymer with poly(oxyethylene); molecular weight (in amu) 2,400—3,500” and by alphabetically adding a polymer to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. * * * * * Oxirane, methyl-, polymer with Oxirane, Monobutyl Ether 9038-95-3 * * * * * [FR Doc. E6-11952 Filed 7-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0551; FRL-8075-7] 2H-Azepin-2-one, 1-Ethenylhexahydro-, Homopolymer I; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer; when used as an inert ingredient in a pesticide chemical formulation BASF AG submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0551. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)308-8380; e-mail address: *gandhi.bipin@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111) • Animal production (NAICS code 112) • Food manufacturing (NAICS code 311) • Pesticide manufacturing (NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0551 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0551, by one of the following methods. • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of March 1, 2006 (71 FR 10505) (FRL-7762-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7026) by BASF AG, 67052 Ludwigshafen, Germany. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer; CAS Reg. No. 25189-83-7. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The polymer's number average molecular weight

(MW)of 4,500 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer is 4500 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer and any other substances and 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of 2H-azepin-2-one, 1-ethenylhexahydro-, homopolymer from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 10, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371 2. In § 180.960 the table is amended by alphabetically adding a polymer to read as follow: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. /BOXHD> * * * * * 2H-Azepin-2-one, 1-ethenylhexahydro-, homopolymer 25189-83-7 * * * * * [FR Doc. E6-11953 Filed 7-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0556; FRL-8077-5] 2-Propenoic Acid, 2-Methyl-, Polymer with Ethenylbenzene, 2-Ethylhexyl 2-Propenoate, 2-Hydroxyethyl 2-Propenoate, N-(Hydroxymethyl) -2-Methyl-2-Propenamide and Methyl 2-Methyl-2-Propenoate, Ammonium Salt; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2- methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt when used as an inert ingredient in a pesticide chemical formulation. E. I. du Pont de Nemours and Company, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996

(FQPA)requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt. DATES: This regulation is effective July 26, 2006. Objections and requests for hearings must be received on or before September 25, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification

(ID)number EPA-HQ-OPP-2006-0556. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(703)308-8380; e-mail address: *gandhi.bipin@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0556 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before September 25, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0556, by one of the following methods. • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 26, 2006 (71 FR 24693) (FRL-8066-3), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 6E7037) by E. I. du Pont de Nemours and Company, Inc., 1007 Market St., Wilmington, DE 19898. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt; CAS Reg. No. 146753-99-3. That notice included a summary of the petition prepared by the petitioner. There were no comments in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . .” and specifies factors EPA is to consider in establishing an exemption. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d). 1. The polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, does contain as an integral part of its composition the atomic elements carbon, hydrogen, nitrogen and oxygen. 3. The polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 4. The polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, is not a water absorbing polymer with a number average molecular weight

(MW)greater than or equal to 10,000 daltons. Additionally, the polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, also meets as required the following exemption criteria specified in 40 CFR 723.250(e). 7. The number average molecular weight

(MW)of polymer, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, is 29,296 which is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt meet all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt. V. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt is 29296 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt conform to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” EPA does not have, at this time, available data to determine whether 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt and any other substances and 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VII. Additional Safety Factor for the Protection of Infants and Children Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt. IX. Other Considerations A. Endocrine Disruptors There is no available evidence that 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt is an endocrine disruptor. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. C. International Tolerances The Agency is not aware of any country requiring a tolerance for 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt nor have any CODEX Maximum Residue Levels

(MRLs)been established for any food crops at this time. X. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-propenoate, N-(hydroxymethyl) -2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt from the requirement of a tolerance will be safe. XI. Statutory and Executive Order Reviews This final rule establishes an exemption from the tolerance requirement under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations 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.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this rule in the **Federal Register** . This rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 10, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.960 is amended by adding alphabetically to the table a polymer to read as follows: § 180.960 Polymers; exemptions from the requirement of a tolerance. Polymer CAS No. * * * * * 2-Propenoic Acid, 2-Methyl-, Polymer with Ethenylbenzene, 2-Ethylhexyl 2-Propenoate, 2-Hydroxyethyl 2-Propenoate, N-(Hydroxymethyl) -2-Methyl-2-Propenamide and Methyl 2-Methyl-2-Propenoate, Ammonium Salt 146753-99-3 * * * * * [FR Doc. E6-11951 Filed 7-25-06; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 42 CFR Part 63a RIN 0925-AA28 National Institutes of Health Training Grants AGENCY: National Institutes of Health, Department of Health and Human Services. ACTION: Final rule. SUMMARY: The National Institutes of Health

(NIH)is amending the current regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training. DATES: *Effective Date:* This final rule is effective August 25, 2006. FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892, telephone 301-496-4607 (not a toll-free number). SUPPLEMENTARY INFORMATION: On October 17, 2000, Congress enacted the Children's Health Act of 2000, Public Law 106-310. Title X, section 1002, of this law amended the Public Health Service

(PHS)Act by adding section 452G (42 U.S.C. 285g-10). Section 452G directs the Director of the National Institute of Child Health and Human Development, after consultation with the Administrator of the Health Resources and Services Administration, to support activities to provide for an increase in the number and size of institutional training grants to institutions supporting pediatric training. We are amending the current regulations codified at 42 CFR part 63a, “National Institutes of Health Training Grants,” to implement this pediatric research training grants authority. More specifically, we are amending part 63a to reference section 452G of the PHS Act in the authority section and in paragraph (a)(2) of § 63a.1 of the regulations, and update information in the 18th, 19th, and 20th undesignated paragraphs of § 63a.11. We announced our intention to amend the training grants regulations by publishing the notice of proposed rulemaking (NPRM), “National Institutes of Health Training Grants,” in the **Federal Register** of January 28, 2005 (70 FR 4080-4081). The NPRM provided for a 60-day public comment period. The comment period expired on March 29, 2005. We received no comments. Therefore, the amending action reflected in this final rule is the same as what we proposed in the NPRM. We provide the following as public information. Executive Order 12866 Executive Order 12866, Regulatory Planning and Review, requires that all regulatory actions reflect consideration of the costs and benefits they generate, and that they meet certain standards, such as avoiding the imposition of unnecessary burdens on the affected public. If a regulatory action is deemed to fall within the scope of the definition of the term “significant regulatory action” contained in section 3(f) of the Order, prepublication review by the Office of Management and Budget's Office of Information and Regulatory Affairs

(OIRA)is necessary. The OIRA reviewed this final rule under Executive Order 12866 and deemed it not a significant regulatory action as defined by the Executive Order. Regulatory Flexibility Act The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that regulatory proposals be analyzed to determine whether they create a significant impact on a substantial number of small entities. The Secretary of Health and Human Services (Secretary) certifies that this final rule does not have such impact. Executive Order 13132 Executive Order 13132, Federalism, requires that Federal agencies consult with State and local government officials in the development of regulatory policies with federalism implications. The Secretary reviewed this final rule as required under the Executive Order and determined that it does not have federalism implications. The Secretary certifies that this final rule will not have an effect on the States, or on the distribution of power and responsibilities among the various levels of government. Paperwork Reduction Act This final rule does not contain information collection requirements which are subject to Office of Management and Budget

(OMB)approval under the Paperwork Reduction Act of 1995, as amended (44 U.S.C. chapter 35). Catalogue of Federal Domestic Assistance The Catalogue of Federal Domestic Assistance numbered program affected by the proposed regulation is: 93.865. List of Subjects in 42 CFR Part 63a Grant programs—health; Health—medical research. Dated: April 12, 2006. Elias A. Zerhouni, Director, National Institutes of Health. Approved: July 18, 2006. Michael O. Leavitt, Secretary. For the reasons set forth in the preamble, we amend chapter 1 of title 42 of the Code of Federal Regulations as set forth below. PART 63a—NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS 1. The authority citation of part 63a is revised to read as follows: Authority: 42 U.S.C. 216, 242 *1* (b)(3), 284(b)(1)(C), 285g-10, 287c(b), 300cc-15(a)(1), 300cc-41(a)(3)(C), 7403(h)(2). 2. Section 63a.1 is amended by revising paragraph (a)(2) to read as follows: § 63a.1 To what programs do these regulations apply?

(a)* * *

(2)Grants awarded by NIH for research training with respect to the human diseases, disorders, or other aspects of human health or biomedical research for which the institute or other awarding component was established, for which fellowship support is not provided under section 487 of the Act and which is not residency training of physicians or other health professionals, as authorized by sections 405(b)(1)(C), 452G, 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and, 3. Section 63a.11 is amended by revising the 18th, 19th, and 20th undesignated paragraphs to read as follows: § 63a.11 Other HHS regulations and policies that apply. “NIH Grants Policy Statement,” (December 1, 2003). This version is located on the NIH Web site at: *http://grants./policy/nihgps_2003/index.htm.* [ Note: this policy is subject to change, and interested persons should contact the Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research, NIH, 6701 Rockledge Drive, Suite 350, MSC 7974, Bethesda, Maryland 20892-7974, telephone 301-435-0938 (or toll-free 800-518-4726), to obtain references to the current version and any amendments. Information may also be obtained by contacting the OPERA Division of Grants Policy via e-mail at *http://GrantsPolicy@mail.nih.gov.* Previous versions of the NIH Grants Policy Statement are archived at *http://grants.nih.gov/grantspolicy/policy.htm.* ] “Public Health Service Policy on Humane Care and Use of Laboratory Animals,” Office of Laboratory Animal Welfare (Amended August, 2002). [ Note: this policy is subject to change, and interested persons should contact the Office of Laboratory Animal Welfare, 6705 Rockledge Drive, Suite 360, MSC 7982, Bethesda, Maryland 20892-7982, telephone 301-594-2382 (not a toll-free number), to obtain references to the current version and any amendments. Information may also be obtained by browsing the Office of Laboratory Animal Welfare Home Page site on the World Wide Web ( *http://www.grants.nih.gov/grants/olaw/olaw.htm* ).] [FR Doc. E6-11924 Filed 7-25-06; 8:45 am] BILLING CODE 4140-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [File No. CCB/CPD No. 00-1; FCC 06-98] Payphone Line Rates; New Services Test AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Commission issued this document responding to a petition for correction submitted by Verizon, Inc. and a petition for reconsideration submitted by the Wisconsin Pay Telephone Association (WPTA). The Commission granted Verizon's petition to correct the order by clarifying that Verizon's affiliate, Verizon North, is not a Bell Operating Company

(BOC)by definition of the Act. The Commission denied the WPTA's petition for reconsideration of the Commission's decision that the Wisconsin Public Utility Commission should properly determine BOC intrastate payphone line rates in the State of Wisconsin to determine compliance with the new services test established by the Commission. DATES: Effective August 25, 2006. FOR FURTHER INFORMATION CONTACT: Ana Janckson-Curtis, Wireline Competition Bureau, Pricing Policy Division,

(202)418-1530. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's order on reconsideration in File No. CCB/CPD No. 00-01 released on July 7, 2006. The full text of this document is available on the Commission's Web site and for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 Twelfth Street, SW., Washington, DC 20554. Procedural Matters Paperwork Reduction Act Analysis This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4). Report to Congress The Commission will not send a copy of this order on reconsideration pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of particular applicability. Background In the Wisconsin Order, the Commission affirmed a Common Carrier Bureau order holding that section 276 of the Act grants this Commission jurisdiction to require BOCs to set their intrastate payphone line rates in compliance with the Commission's cost-based, forward-looking “new services” test. The Commission also found, however, that it lacks authority to impose this requirement on non-BOC LECs. The order also provided guidance to the states regarding application of the new services test. Discussion The Act defines “Bell operating company” to include 20 companies specifically named in the statute, as well as “any successor or assign of such company that provides wireline exchange service,” but it expressly excludes “an affiliate of such company” other than one of the named companies or their successors or assigns. As a result of a merger between GTE and Verizon, GTE North was renamed Verizon North and became an affiliate of Verizon, but it is not one of the companies defined as a BOC, nor is it a successor or assign of Verizon. Accordingly, the Commission concluded that Verizon North is not a BOC, and it is not within this Commission's jurisdiction to mandate application of the new services test to its intrastate payphone line rates. The Wisconsin Commission has concluded that it has jurisdiction to determine whether payphone line rates comply with the new services test. It has also undertaken investigations and issued a Notice of Proceeding and Investigation and Assessment of Costs to Wisconsin Bell d/b/a SBC Wisconsin. This action is consistent with the Commission's previously stated view that payphone line rates should, to the extent possible, be reviewed by the appropriate state commission. In light of the decision of the Wisconsin Commission to review intrastate payphone line rates, and the actions of the Wisconsin Commission in undertaking investigations, the Commission denied the WPTA's request to evaluate Ameritech's and Verizon's payphone line rates. Conclusion This order grants Verizon's petition for correction by clarifying that the Commission's jurisdiction to mandate application of the new services test to intrastate payphone line rates does not extend to Verizon North, previously known as GTE North. Verizon North is not a BOC under the Act. The order also denies the WPTA's petition for reconsideration, which asks the Commission to review cost support materials submitted by Verizon and Ameritech, and defers to the Wisconsin Commission to determine whether Ameritech's payphone line rates comply with the new services test established by the Commission and whether the new services test should apply to the payphone line rates of other Wisconsin LECs. Ordering Clauses Accordingly, *it is ordered* , pursuant to sections 4(i), 4(j), and 276 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), and 276, and § 1.106 of the Commission's rules, 47 CFR 1.106, that the petition for correction filed by Verizon is granted as discussed herein. *It is also ordered* that, for the reasons stated above, the WPTA petition for reconsideration *is denied.* Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E6-11899 Filed 7-25-06; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 64 [CG Docket Nos. 02-278 and 05-338; FCC 06-42] Rules and Regulations Implementing the Telephone Consumer Protection Act of 1991; Junk Fax Prevention Act of 2005 AGENCY: Federal Communications Commission. ACTION: Final rule; announcement of effective date. SUMMARY: In this document, the Commission announces that the Office of Management and Budget

(OMB)has approved for three years the information collections contained in the *Rules and Regulations Implementing the Telephone Consumer Protection Act

(TCPA)of 1991, Report and Order and Third Order on Reconsideration (Report and Order)* . The *Report and Order* states that the Commission will publish a document in the **Federal Register** announcing the effective date of this rule. DATES: 47 CFR 64.1200(a)(3)(i), (ii), (iii),

(iv)and

(vi)published at 71 FR 25967 (May 3, 2006) are effective August 1, 2006. FOR FURTHER INFORMATION CONTACT: Erica H. McMahon, Consumer Policy Division, Consumer & Governmental Affairs Bureau at

(202)418-0346. SUPPLEMENTARY INFORMATION: This document announces that, on July 19, 2006, OMB approved for three years the information collections contained in 47 CFR 64.1200(a)(3)(i), (ii), (iii),

(iv)and (vi), published at 71 FR 25967 (May 3, 2006). The OMB Control Number is 3060-1088. The Commission publishes this notice of the effective date of the rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please write to Leslie F. Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554. Please include the OMB Control Number, 3060-1088, in your correspondence. The Commission will also accept your comments via the Internet if you send them to *Leslie.Smith@fcc.gov* , or you may call

(202)418-0217. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to *fcc504@fcc.gov* or call the Consumer & Governmental Affairs Bureau at

(202)418-0530 (voice),

(202)418-0432 (TTY). Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received approval from OMB on July 19, 2006, for the collections of information contained in 47 CFR 64.1200(a)(3)(i), (ii), (iii),

(iv)and (vi). The total annual reporting burden associated with this collection of information, including the time for gathering and maintaining the collections of information, is estimated to be: 5,000,000 respondents, a total annual hourly burden of 13,180,000 hours, and $60,000,000 in total annual costs. Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid OMB Control Number. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, 44 U.S.C. 3507. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E6-12024 Filed 7-25-06; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 RIN 1018-AI80 Endangered and Threatened Wildlife and Plants; Establishment of a Nonessential Experimental Population of Northern Aplomado Falcons in New Mexico and Arizona AGENCY: Fish and Wildlife Service, Interior. ACTION: Final rule. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), plan to reintroduce northern aplomado falcons ( *Falco femoralis septentrionalis* ) (falcon) into their historical habitat in southern New Mexico for the purpose of establishing a viable resident population in New Mexico and Arizona. The falcon is being re-established under section 10(j) of the Endangered Species Act of 1973, as amended (Act), and would be classified as a nonessential experimental population (NEP). The geographic boundary of the NEP includes all of New Mexico and Arizona. This action is part of a series of reintroductions and other recovery actions that the Service, Federal and State agencies, and other partners are conducting throughout the species” historical range. This final rule provides a plan for establishing the NEP and provides for limited allowable legal taking of the northern aplomado falcon within the defined NEP area. Birds can only be released when they are a few weeks old, and this condition only occurs in the spring and summer of each year. In order to accomplish a release in 2006, we must expedite on-the-ground implementation. DATES: The effective date of this rule is July 26, 2006. ADDRESSES: Comments and materials received, as well as supporting documentation used in preparation of this final rule, are available for public inspection, by appointment, during normal business hours at the New Mexico Ecological Services Field Office, 2105 Osuna Road, NE., Albuquerque, New Mexico 87113. You may obtain copies of the final rule, environmental analysis, and monitoring plan from the field office address above, by calling

(505)346-2525, or from our Web site at *http://www.fws.gov/ifw2es/NewMexico/.* FOR FURTHER INFORMATION CONTACT: Adam Zerrenner, Acting Field Supervisor, New Mexico Ecological Services Field Office at the above address (telephone 505-346-2525, facsimile 505-346-2542). SUPPLEMENTARY INFORMATION: Background Background information that was previously provided in our February 9, 2005, proposed rule (70 FR 6819) has been condensed in this rule. Biological The northern aplomado falcon (hereafter referred to as falcon) is one of three subspecies of the aplomado falcon and the only subspecies recorded in the United States. This subspecies was listed as an endangered species on February 25, 1986 (51 FR 6686). The falcon is classified in the Order Falconiformes, Family Falconidae. Historically, falcons occurred throughout coastal prairie habitat along the southern Gulf coast of Texas, and in savanna and grassland habitat along both sides of the Texas-Mexico border, southern New Mexico, and southeastern Arizona. Falcons were also present in the Mexican States of Tamualipas, Veracruz, Chiapas, Campeche, Tabasco, Chihuahua, Coahuila, Sinaloa, Jalisco, Guerrero, Yucatan, and San Luis Potosi, and on the Pacific coast of Guatemala and El Salvador (Keddy-Hector 2000). Falcons were fairly common in suitable habitat throughout these areas until the 1940s, but subsequently declined rapidly. From 1940 to the present in Arizona (Corman 1992), and from 1952 to 2000 in New Mexico (Meyer and Williams 2005), there were no documented nesting attempts by wild falcons. In 2001 and 2002, one pair of falcons nested in Luna County, New Mexico. This pair was unsuccessful in producing fledglings in 2001, but produced three fledglings in 2002. To date, the 2002 nest has been the only known successful falcon nest in either Arizona or New Mexico since 1952. The causes for decline of this subspecies have included widespread shrub encroachment resulting from control of range fires and intense overgrazing (Service 1986; Burnham *et al.* 2002) and agricultural development in grassland habitats used by the falcon (Hector 1987; Keddy-Hector 2000). Pesticide exposure was likely a significant cause of the subspecies” extirpation from the United States with the initiation of widespread DDT (dichloro-diphenyl-trichloroethane) use after World War II, which coincided with the falcon's disappearance (51 FR 6686, February 25, 1986). Falcons in Mexico in the 1950s were heavily contaminated with DDT residue, and these levels caused a 25 percent decrease in eggshell thickness (Kiff *et al.* 1980). Such high residue levels can often result in reproductive failure from egg breakage (Service 1990). Collecting falcons and eggs may have also been detrimental to the subspecies in some localities. However, populations of birds of prey are generally resilient to localized collection pressure (Service 1990). Currently, long-term drought, shrub encroachment in areas of Chihuahuan grasslands, and the increased presence of the great-horned owl ( *Bubo virginianus* ), which preys upon the falcon, may be limiting recovery of this subspecies. On the other hand, falcons appear to be relatively tolerant of human presence. They have been observed to tolerate approach to within 100 meters

(m)(328 feet (ft)) of their nests by researchers and have nested within 100 m (328 ft) of highways in eastern Mexico (Keddy-Hector 2000), and are frequently found nesting in association with well-managed livestock grazing operations in Mexico and Texas (Burnham *et al.* 2002). Burnham *et al.*

(2002)concluded that falcons would be able to coexist with current land-use practices in New Mexico on the broad scale. Over the past decade, widespread formal surveys have been conducted in southern New Mexico habitats capable of supporting individual or breeding falcons (suitable habitat). Standardized falcon surveys have been conducted annually in suitable falcon habitats on White Sands Missile Range and Fort Bliss by the Department of Defense throughout the past decade (Burkett and Black 2003; Griffin 2005a; Locke 2005). White Sands Missile Range in central New Mexico contains one million hectares

(ha)(2.5 million acres (ac)). The northwest corner (81,000 ha (200,000 ac)) is highly suitable yucca/grassland preferred by falcons. There is presently no livestock grazing and no public access to this area. The 145,139-ha (358,643-ac) Armendaris Ranch, located in south central New Mexico, contains undeveloped Chihuauhuan desert grassland managed by Turner Properties in cooperation with the Turner Endangered Species Fund. Armendaris Ranch managers have volunteered to provide falcon reintroduction sites, and the Armendaris Ranch and areas immediately adjacent to known falcon habitat in Luna County have been surveyed on several occasions in recent years (Howard 2006a; Meyer and Williams 2005). Falcon surveys were conducted in 2003 on the Gray Ranch in southeastern New Mexico, which contains 130,410 ha (322,000 ac) (Lewis 2005). It includes extensive desert grasslands at its lower elevations. Bird life is abundant on the Gray Ranch; 43 percent of New Mexico's avian species occur there and would provide an excellent prey base for falcons. The Bureau of Land Management

(BLM)office in Las Cruces and the New Mexico Department of Game and Fish (NMDGF) have also recently sponsored formal surveys for falcons in suitable habitats in the subspecies” historic range in New Mexico (Howard 2006a; Meyer and Williams 2005; Lister 2006a; Lister 2006c). Therefore, large areas of the southern New Mexico habitats most capable of supporting individual or breeding pairs of falcons have been formally surveyed for the presence of falcons during the past 10 years, and the results of these surveys follow. After a 50-year absence, an unsuccessful nesting attempt was documented in Luna County, New Mexico, in the spring of 2001 (Meyer and Williams 2005). In 2002, a pair at this location successfully fledged three chicks. In 2003, only a single female was seen in the area of the 2002 nest. In 2004, a pair of falcons was seen for a short time at this location, but no nesting was detected and this male left in late May (Meyer and Williams 2005). In 2005, only a single female was observed at this site (Meyer 2005). In 2006, this breeding territory has been repeatedly surveyed, and no falcons were detected there from February through May, although a falcon was reported to be observed in a nearby area in late May (Lister 2006c). Formal surveys and reliable sightings submitted to the Service show that a small number of falcons have occurred in New Mexico, with a small number of sightings occurring in every decade since the 1960s (Williams 1997; Howard 2006a; Howard 2006b; Meyer and Williams 2005; Service 2005; Howe 2006). Although it is a species highly sought after by bird watchers and other naturalists, an average of only 2.5 sightings was reported per year during the 1990s in New Mexico (Service 2005). Despite increasing public interest, survey effort, and reporting requirements ( *e.g.,* section 10 (a)(1)(A) recovery permits), from 2000 through 2005, this average only increased to 4.0 sightings reported per year in the State, including the Luna County appearance of the first nest in either New Mexico or Arizona since 1952 (Service 2005). On May 8, 2002, two additional falcons were observed that were thought to be different from the known nesting pair in Luna County. However, only one individual thought to be from that potential second pair was present two days later, and a second falcon nest was never located anywhere in the NEP area (Meyer and Williams 2005). In 2003 and 2004, other than the Luna County territory, no additional falcons were reported from formal surveys in New Mexico (Meyer and Williams 2005). In 2005 and through April 2006, there were nine sightings at locations in New Mexico apart from the Luna County territory (Burkett 2005; Banwart 2006; Howard 2006b; Locke 2006). Only the sighting on August 11, 2005, detected more than one falcon. The two falcons observed on that day did not exhibit behaviors that indicated they were a pair, and a photograph taken of one suggested it was a juvenile (Howard 2005a;b). Repeated follow-up by highly qualified, experienced falcon surveyors of four of these detections, including the sighting of two birds, revealed that none of these falcons appeared to be local residents or defending a territory (Griffin 2005b; Howard 2005b; Lister 2006b; Lister 2006c; Locke 2006). Absolute numbers of falcons sighted in New Mexico are unknown because all but one sighting has been of unbanded birds. Montoya *et al.*

(1997)and Macias-Duarte *et al.*

(2004)banded a number of juvenile falcons in the Mexican State of Chihuahua between 1996 and 2002. To date, one juvenile bird banded in this study has been seen in New Mexico. It was observed on Otero Mesa in 1999 (Howard 2006a). In Arizona, the most recent documented occurrences of falcons were recorded in 1975 and 1977, with one unconfirmed sighting in southern Arizona near the Mexican border in November 2005 (Howard 2006a). These sightings in New Mexico and Arizona may represent falcons dispersing from the population in Chihuahua that were opportunistically foraging in areas rich in prey due to vegetative growth from precipitation (Howard 2005a). It has been noted that significant re-colonization of habitats in Arizona and New Mexico by naturally occurring birds in Chihuahua would likely take decades, if it occurred at all, because the reproductive rate of the falcons in Chihuahua has typically been low. The low reproductive rate is possibly due to the effects of extended drought, and this population has not been expanding (Burnham *et al.* 2002; Jenny and Heinrich 2004). In addition, the majority of the breeding pairs in Chihuahua are clustered in close proximity to one another, but most are approximately 120 to 135 miles away from the southern New Mexico border (Howard 2006c). As stated in the Recovery Plan for the falcon (1990), “Regardless of the status of the aplomado falcon in Mexico, an attempt should be made to establish populations in the United States. If release sites are carefully chosen, reestablished populations should be relatively free from pesticide contamination. Releases may facilitate range expansion because pesticide contamination may have reduced the ability of most populations to colonize new patches of suitable habitat. The potential for range expansion is now more promising as a result of recent brush control efforts in southern and coastal Texas and the discontinued use of DDT.” Recovery Efforts There are currently 46 pairs of aplomado falcons in the captive population, which produces more than 100 young per year. From this captive population, 1,142 captive-bred falcons have been released in Texas (Juergens and Heinrich 2005). The Peregrine Fund conducted a pilot release project in Texas from 1985 to1989, and increased restoration efforts began in 1993. These releases have established at least 44 pairs in southern Texas and adjacent Taumalipas, Mexico, where no pairs had been recorded since 1942 (Jenny *et al.* 2004). Moreover, pairs of reintroduced falcons began breeding in 1995, and to date have successfully fledged more than 244 young (Juergens and Heinrich 2005). Nests have been located on a variety of structures, both artificial and natural. Predation by great-horned owls, raccoons ( *Procyon lotor* ), and coyotes ( *Canis latrans* ) is significant, affecting more than half of all nesting attempts (Jenny *et al.* 2004). Nesting productivity increased by approximately 40 percent in 2003 and 2004, when falcons were provided artificial nesting structures with barred sides arranged so that falcons can enter the nest while predators cannot (Jenny *et al.* 2004). Pairs of falcons in south Texas successfully fledged young where they had never been successful prior to the use of the new artificial nests. Beginning in 2002, falcons have also been released in west Texas under a Safe Harbor Agreement with The Peregrine Fund. In 2005, 138 falcons were released at six sites on private ranches in the trans-Pecos region of the State, and of these, 116 successfully reached independence (Juergens and Heinrich 2005). All of these releases in Texas have occurred on private property under Safe Harbor Agreement permits, currently with an enrollment of more than 728,000 ha (1.8 million ac). Safe Harbor Agreements are between a private land owner and the Service that permit future incidental taking of listed species on their private land. Releases have also occurred on Laguna Atascosa, Matagorda Island, and Aransas National Wildlife Refuges in Texas. We believe that it is also possible to accelerate the establishment of a breeding population in the Southwest through reintroductions of captive-raised birds in New Mexico. The experience in Texas, where the population went from no known pairs in 1994, to 44 known pairs that produced at least 244 young by 2005, illustrates the rapidity with which a population can be established through reintroductions. Despite the relative success of the falcon releases in Texas, we believe the Safe Harbor Agreements used to release falcons in Texas are not the best mechanism for re-establishing falcons in New Mexico and Arizona. Safe Harbor Agreements can only be developed for private land owners. There is a vast amount of public land in New Mexico and Arizona, totaling approximately 40 percent of the reintroduction area. Therefore, public land is very important for recovery of the falcon in this area. Not only is the public land important because of its high percentage in the reintroduction area, but it is important because of its habitat characteristics. The historical range in the NEP area is Chihuahuan Desert grassland, and public lands make up approximately 50 percent of the Chihuahuan Desert grassland compared to private land (Young *et al.* 2002). We believe there is very low probability that falcons will populate lands outside of their historical range because those habitats would not be suitable for falcons. Thus far, we have not detected falcons inhabiting areas outside of their historical range. Extensive grasslands that would support individual or breeding falcons occur on Otero Mesa, White Sands Missile Range, southern Hidalgo County (Gray Ranch), and the Armendaris Ranch/Stallion Range area (Howard 2006a). Approximately one-half of the Chihuahuan Desert grasslands in New Mexico are federally managed, and often intermingled with State and private land. Falcons moving between Safe Harbor lands and non-Safe Harbor lands would receive different levels of protection from the Act. Activities that may affect falcons on Federal lands (or on non-Federal lands for projects using Federal permitting, funding, or authorization) would require section 7(a)(2) consultation. Falcons released on private lands with Safe Harbor Agreements that move to non-Safe Harbor lands would receive the full protection of the Act. Actions that may take falcons on private lands would also be subject to the Act's regulatory requirements. We believe such an approach would be less efficient than establishing an NEP, would be difficult to regulate, and would ultimately provide less conservation benefit to the falcon than establishing an NEP. The Secretary has broad discretion to manage populations to better conserve and recover endangered species. The term “experimental population” means any population, including any of their offspring, authorized by the Secretary for release, only when the population is wholly separate geographically from nonexperimental populations of the same species. In the case of the falcon,

(1)This subspecies has been known to disperse up to 250 kilometers,

(2)it would be virtually impossible to preclude naturally occurring individual falcons from intermingling with the experimental population, and

(3)there has been only one pair that has reproduced one time within the NEP area. Designation of a 10(j) NEP requires that the reintroduced animals be “wholly separate” from any existing population. We do not consider the pair of falcons that bred in 2002 in Luna County to constitute a population. Therefore, the exclusion of the counties surrounding the 2002 pair from the 10(j) designation is not necessary. We identify the experimental population as all falcons found within the NEP area, including reintroduced falcons and any lone dispersers and their offspring. We believe this is the best manner by which to manage the falcon reintroduction program to achieve species recovery. The Act does not require the protection of individuals to the exclusion or detriment of overall species recovery, or otherwise limiting the Department of the Interior's flexibility and discretion to define and manage an experimental population pursuant to section 10(j) ( *Wyoming Farm Bureau Federation* v. *Babbitt* , 199 F.3d 1224 (10th Cir. 2000)). That decision affirmed the Service's determination of whether individual wolves constituted a population. Regulations define “population” as a potentially self-sustaining “group of fish or wildlife in the same taxon below the subspecific level, in common spatial arrangement that interbreed when mature,” (50 CFR 17.3). The term experimental population means “an introduced and/or designated population (including any off-spring arising solely therefrom) that has been so designated in accordance with the procedures of this subpart but only when, and at such times as the population is wholly separate geographically from nonexperimental populations of the same species” (50 CFR 17.80). These definitions preclude the possibility of population overlap as a result of the presence of individual dispersing falcons, because by definition, lone dispersers do not constitute a population or even part of a population, since they are not in “common spatial arrangement” sufficient to interbreed with other members of a population. Congress defined “species,” consistent with its broad conservation and recovery goals, to constitute distinct, interbreeding population segments or subspecies, not individual animals. By definition then, an individual animal does not constitute a species, population, or population segment. In the case of the gray wolf, the Department of the Interior, exercising its discretion under section 10(j), reasonably interpreted the phrase “current range” to be the combined scope of territories defended by the breeding pairs of an identifiable wolf pack or population ( *Wyoming Farm Bureau Federation* v. *Babbitt* , 199 F.3d 1224 (10th Cir. 2000)). We have used the same approach for the falcon. Therefore, a population of falcons does not exist in the NEP area. Breeding falcons are not evenly distributed between the United States border and the Chihuahuan group of falcon pairs. There is a gap of approximately 222 km (138 mi) between the Luna County pair in New Mexico and the most northern, known Chihuahuan breeding pair in Mexico (Howard 2006c). The single pair of New Mexico falcons that successfully reproduced only once in 2002 (after a 50-year absence) is neither self-sustaining, a group, nor in common spatial relationship with the group of approximately 25 to 35 breeding falcon pairs in Mexico. These Mexico falcons occur 160 kilometers

(km)(100 miles (mi)) or more south of the United States border. They are clustered in common spatial relationship, are self-sustaining, and are interbreeding. We do not consider the New Mexico 2002 nesting pair and any offspring produced by the pair to be a population. Biologically, the term “population” is not normally applied to a single pair, and so the few birds sighted in New Mexico could be considered dispersers from the Chihuahuan population. In addition, we have no authority to manage a population in a different country. Therefore, the existence of a group in Mexico should not preclude conservation and management of falcons in the United States in order to achieve species recovery. Furthermore, two, or even three, birds are not considered a self-sustaining population. Self-sustaining populations require a sufficient number of individuals to avoid inbreeding depression and occurrences of chance local extinction (Caughley and Gunn 1996). Designation of an NEP under section 10(j) of the Act requires that the reintroduced animals be “wholly separate geographically” from any existing population. As stated above, we do not consider the pair of falcons that bred in 2002 in Luna County, New Mexico, to constitute a population. Therefore, the exclusion of the counties surrounding the 2002 pair from the 10(j) designation is not necessary. Creating an NEP area that excludes the counties surrounding the documented New Mexico pair (Hidalgo, Grant, and Luna counties) would create a complex regulatory situation. If falcons that are released in the NEP area move into the excluded area, then they would receive the full protection of the Act. Federal land managers in the NEP-excluded area may therefore be subject to the full regulatory requirements of section 7(a)(2) for falcons that were released in the NEP area. If a falcon released in the NEP area settles on private lands, the private land owner would be prohibited from any action that may incidentally “take” the falcon. We believe the recovery of the falcon can be achieved without imposing these regulatory restrictions on land managers and the public that excluding some counties from the NEP area would require. Reintroduction Sites Falcons historically occurred in Chihuahuan Desert grasslands within the NEP area, and habitats in these areas are similar to those that support nesting falcons in northern Mexico populations. Primary considerations for identifying falcon release sites include areas:

(1)Within or in proximity to potentially suitable habitat, including open grassland habitats that have scattered trees, shrubs, or yuccas for nesting and perching;

(2)supporting available prey for falcons ( *e.g.* , insects, small to medium-sized birds, rodents);

(3)with minimal natural and artificial hazards ( *e.g.* , predators, open-water tanks) and potential hazards that can be minimized where practical;

(4)with access for logistical support;

(5)with a large extent of potentially suitable habitat surrounding a release site and its proximity to other similar habitats; and

(6)with a willing landowner or land manager. While the NEP area will include both Arizona and New Mexico, the reintroduction sites will only be on lands within New Mexico. The State of Arizona is supportive of having falcons re-established in the State under a 10(j) designation, but does not wish to conduct reintroductions. Reintroduction sites within the NEP area will be selected to increase the distribution of the population and its rate of growth. Selection will be based upon suitability and extent of available habitat, as well as any dispersal patterns from prior releases. Released falcons are expected to move around within the areas of their release, but may disperse to more distant areas. The 10(j) designation and supporting 4(d) rule cover both private and public lands in New Mexico and Arizona, so Safe Harbor Agreements will not be necessary with private landowners. Reintroduction The rearing and reintroduction techniques that will be used in establishing this NEP have proven successful in establishing a wild population of falcons in southern Texas. Falcons will be raised in The Peregrine Fund's captive propagation facility in Boise, Idaho. Newly hatched falcon chicks are fed by hand in sibling groups for up to 25 days. They are then raised in sibling groups with minimal human exposure until their transportation to a reintroduction site at 32 to 37 days of age. Careful timing of the age for reintroducing falcons is important to increase their chances for successfully fledging and reaching independence (Sherrod *et al.* 1987). Falcons are shipped by air between Boise and the release locations and driven to the hack site ( *i.e.* , release site). At the hack site, the falcons are placed in a protective box on top of a conspicuous tower and fed for 7 to 10 days. The box is then left open and falcons are allowed to come and go freely. Food is provided on the tower and, initially, the falcons return each day to feed. Eventually, the falcons begin chasing prey, making their own kills, and spending more and more time away from the hack site. A falcon is considered to be “successfully released” when it is no longer dependent on food provided at the hack site. This process generally takes from 3 to 6 weeks (Jenny *et al.* 2004). The hack site attendants will evaluate the progress of the released falcons. The reintroduction process can be extended to ensure a successful release or a bird may be returned to the propagation facility in Boise if it does not attain independence (Sherrod *et al.* 1987). Status of Reintroduced Population Before authorizing the release of any population, the Secretary shall determine, on the basis of the best available information, whether or not such a population is essential to the continued existence of an endangered species or a threatened species. The proposed experimental falcon population will be designated “non-essential, experimental”

(NEP)because:

(1)There are established populations in Mexico and a rapidly expanding population in south Texas;

(2)reintroductions will continue in western Texas;

(3)the Boise, Idaho, captive population is producing enough offspring to maintain the captive flock and provide falcons for release; and

(4)the possible failure of this action would not appreciably reduce the likelihood of survival of the subspecies in the wild. We also believe the NEP designation lessens land-use restrictions associated with the Act, which makes the establishment of falcons in New Mexico and Arizona less controversial to private landowners and agency land managers, and should result in more cooperative falcon conservation efforts with stakeholders and a larger number of release sites and more widespread reintroductions. Therefore, the use of the NEP should be the fastest way to both

(1)successfully establish a falcon population in New Mexico and Arizona, and

(2)aid in recovery and eventual delisting of the falcon. Thus, we have determined this experimental population to be nonessential to the continued existence of the species according to the provisions of section 10(j) of the Act for the following reasons:

(a)With at least three populations—one in eastern Mexico, a second in northern Chihuahua, Mexico, and a third becoming established in southern Texas—the experimental population is not essential to the continued existence of the species. The threat of extinction from a single catastrophic event has been reduced by a gradual increase of the southern Texas and captive populations. Thus, loss of the experimental population will not appreciably reduce the likelihood of falcon survival in the United States; and,

(b)Any birds lost during the reintroduction attempt can be replaced through captive breeding. Production from the extant captive flock is already sufficient to support the release of birds that would occur under this final rule, in addition to continued releases in west Texas (Juergens and Heinrich 2005). We fully expect that the NEP will result in the establishment of a self-sustaining, resident population, which will contribute to the recovery of the species. We expect these reintroductions to be compatible with current or planned human activities in the NEP area (Burnham *et al.* 2002). There has been only one reported conflict between human activities and falcons in Texas, where 1,142 falcons have been released over the course of 20 years (Burnham *et al.* 2002; Bond 2005; Jenny 2005; Robertson 2006). That issue involved the use of agricultural pesticides in proximity to falcon reintroduction sites in Texas in the early 1990s, and a viable resolution of the conflict was obtained. The Service will use the best scientific and commercial data available, including, but not limited to, results from the monitoring plan developed with this rule and stakeholder meetings to prepare 5-year evaluations of the reintroduction program. If the actions carried forward as a result of this final rule fail to demonstrate sufficient success toward recovery, as determined by the Service, then the Service, in coordination with other Federal land managers, the States of Arizona and New Mexico, and private collaborators, would reevaluate management strategies. Although there are still questions to research while these reintroductions proceed, the success of the southern Texas reintroductions suggests that this effort will have similar positive results for the recovery of the falcon. Based on that experience, we have good reason to believe that appropriately managed captively reared birds are suitable for release into the wild and can survive and successfully reproduce. Although prey-base biomass may be lower throughout the NEP area than in southern Texas, the prey-base biomass in the NEP area is similar to occupied habitat in Chihuahua, Mexico (Truett 2002). Furthermore, the establishment of a third self-sustaining population in the United States provides further assurance that the species will recover here. For example, if the southern Texas population was significantly impacted by a catastrophic event, such as a Gulf coast hurricane, the NEP in New Mexico and the reintroduced falcons in western Texas would provide buffers for the species in the wild while the southern Texas population recovered. Location of Reintroduced Population Section 10(j) of the Act requires that an experimental population be geographically separate from other populations of the same species. The NEP area covers all of New Mexico and Arizona, with the expectation that falcons would persist only within the Chihuahuan Desert, which extends north from Mexico into southern Texas, southern New Mexico, and southeastern Arizona. The NEP area is geographically isolated from existing falcon populations in Mexico and Texas by a sufficient distance to preclude significant contact between populations. There have been no documented nesting falcons in Arizona and only one known successful nest in New Mexico in over 50 years. However, we do not believe the presence of these falcons constitutes a population, as stated in the “Recovery Efforts” section above. It is difficult to predict where individual falcons may disperse following reintroduction within the NEP area. A 70-day-old male falcon dispersed 136 km (84.5 mi) from a hack site in Texas (Perez *et al.* 1996), and a falcon banded in Chihuahua, Mexico, was observed 250 km (155 mi) north in New Mexico (Burnham *et al.* 2002). Perez *et al.*

(1996)placed radio transmitters on 14 falcons in Texas and found that their home range size varied widely, from 36 to 281 square km (km 2 ) (14 to 108.5 square mi (mi 2 )). Natal dispersal may be localized (Burnham *et al.* 2002). Designation of a large NEP area around planned release sites takes into consideration the potential occurrence and dispersal of falcons in a large geographic area. Any falcon found within the NEP area will be considered part of the NEP. It is possible, though unlikely, that individual captive-bred falcons or their progeny from west Texas could disperse into the NEP area. The majority of falcon reintroductions in west Texas are further than 193 km (120 mi) from suitable habitat in New Mexico, and tall mountains separating the two regions may provide an obstacle to falcon migration. The Guadalupe Mountains span the border between Texas and New Mexico and rise to heights of 8,749 feet. Falcon reintroductions in west Texas only began in 2002, and as expected, there has not yet been any documented breeding by these reintroduced falcons. Furthermore, there have been no detections in New Mexico of falcons that were banded at west Texas reintroduction sites, and all of those reintroduced falcons should be banded. Management Because of the substantial regulatory relief provided by NEP designations, we do not believe the reintroduction of falcons will conflict with existing human activities or hinder public use of the NEP area. The NEP designation will not require land managers to specifically manage for reintroduced falcons. When NEPs are located outside a National Wildlife Refuge or unit of the National Park System, we treat the population as proposed for listing and only two provisions of section 7 would apply: section 7(a)(1) and section 7(a)(4). In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(1) requires Federal agencies to use their authorities to further the conservation of listed species. Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a proposed species. The results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. The Service, The Peregrine Fund, Turner Endangered Species Fund, the States of New Mexico and Arizona, BLM, Department of Defense (DOD), and other cooperators will manage the reintroduction. They will closely coordinate on reintroductions, monitoring, coordination with landowners and land managers, and public awareness, among other tasks necessary to ensure successful reintroductions of falcons.

(a)*Monitoring:* The Service has developed a monitoring plan specific to this NEP and associated release efforts (see ADDRESSES section). Falcons will be observed every day before they are released. Facilities for release of the birds will be modeled after facilities used for falcons in Texas. Information on survival of released birds, movements, behavior, reproductive success, and causes of any losses, will be gathered during the duration of the reintroduction program. Program progress will be summarized and reported annually at stakeholder meetings. As described above, we plan to evaluate the progress of the program every 5 years.

(b)*Disease:* (see information previously provided in our February 9, 2005, proposed rule).

(c)*Genetic Variation:* The captive breeding population of falcons is managed by The Peregrine Fund to maintain and maximize genetic diversity (Burnham *et al.* 2002). This population was derived from nestlings collected from robust populations in Chiapas, Tabasco, and Veracruz, Mexico. Genetic testing was conducted to insure that progeny from falcons collected in southeastern Mexico would be suitable for release in northern Mexico and the United States, where the subspecies had been extirpated. Results from both mitochondrial DNA and microsatellite variation were analyzed, and revealed no genetic divergence between samples that would indicate any problems from reintroducing this lineage into the Chihuahuan grasslands of the United States (Kiff, *in litt* ., 1995; Mindell, *in litt.* , 1997; Burnham *et al.* 2002). This finding is consistent with the known dispersal tendencies of falcons and the fact that these populations are recognized as the same subspecies of northern aplomado falcon ( *Falco femoralis septentrionalis* ).

(d)*Mortality:* For purposes of section 9 of the Act, a population designated as experimental is treated as threatened, regardless of the species' designation elsewhere in its range. Therefore, for purposes of section 9 of the Act, northern aplomado falcons within the NEP will be treated as threatened wherever they are found. A threatened designation allows us greater discretion in devising management programs and special regulations for such a population. The Act defines “incidental take” as take that is incidental to, and not the purpose of, the carrying out of an otherwise lawful activity such as military training, livestock grazing, recreation, and other activities that are in accordance with Federal, tribal, State, and local laws and regulations. A person may take a falcon within the NEP area provided that the take is unintentional and was not due to knowing, intentional, or negligent conduct. Unintentional take will be considered “incidental take,” and is authorized under this final rule via a special rule under section 4(d) of the Act. Although a special rule under section 4(d) of the Act can contain the prohibitions and exceptions necessary and appropriate to conserve that species, regulations issued under section 4(d) for NEPs are usually less restrictive with regard to human activities in the reintroduction area. Thus, take of falcons which is not intentional and is incidental to otherwise lawful activity will be permitted. Applying the results obtained from the reintroductions in south Texas, we expect levels of incidental take to be low since the reintroductions should be compatible with existing land use practices in the area (Burnham *et al.* 2002; Bond 2005; Jenny 2005). Intentional take such as shooting, knowingly destroying a nest, or knowingly harassing falcons from an active nest for purposes other than authorized data collection, will not be permitted.

(e)*Special Handling:* (See information previously provided in our February 9, 2005, proposed rule).

(f)*Coordination with Landowners and Land Managers:* The Service and cooperators identified issues and concerns associated with falcon reintroductions through the National Environmental Policy Act

(NEPA)scoping and two public comment periods. The reintroductions have also been discussed with potentially affected State agencies and some private landowners wishing to have falcons released on their property. Affected State agencies, landowners, and land managers have indicated support for the reintroduction, provided the falcon experimental population is established as a NEP, and land-use activities in the NEP area are not constrained without the consent of affected landowners.

(g)*Potential for Conflict with Military, Industrial, Agricultural, and Recreational Activities:* With proper management, we expect falcon reintroductions to be compatible with current and planned human activities in the NEP area, including agricultural, oil and gas development, military, or recreational activities. There has been only one reported conflict between human activities and falcons in Texas, where 1,142 falcons have been released over the course of 20 years (Burnham *et al.* 2002; Bond 2005; Jenny 2005; Robertson 2006), and that issue was resolved in the early 1990s. Well-managed activities on private, State, and some Federal lands within the NEP area should continue without additional restrictions during implementation of falcon reintroduction activities. As required by section 10(j) of the Act, when the NEP is located within a National Wildlife Refuge or National Park, for section 7 consultation purposes we will treat the reintroduced falcons as threatened under the Act, and therefore the consultation requirements of section 7(a)(2) will apply on these Federal lands. If proposed agricultural, oil and gas development, military, or recreational activities may affect the falcon's prey base within reintroduction areas, State and/or Federal biologists can determine whether falcons could be impacted and, if necessary, work with the other agencies and stakeholders in an attempt to avoid such impacts. If private activities impede the establishment of falcons, we will work closely with State and Federal agencies and/or landowners to suggest alternative procedures to minimize conflicts. The States of Arizona and New Mexico are not directed by this final rule to take any specific actions to provide any special protective measures, nor are they prevented from imposing restrictions under State law, such as protective designations and area closures. Neither of the States within the NEP area, both of which are participants in the northern aplomado falcon working group, has indicated that it would propose hunting restrictions or closures related to game species because of the falcon reintroduction. The principal activities on private property near the initial release areas are agriculture, livestock production, and hunting. We do not believe that use of these private properties by falcons will preclude such private uses because these activities and the falcons’ needs do not conflict with each other. These same human uses are occurring near falcon reintroduction sites in south Texas. As stated above, there has been only one reported conflict between human activities and falcons in Texas, where 1,142 falcons have been released over the course of 20 years (Burnham *et al.* 2002; Bond 2005; Jenny 2005; Robertson 2006), and that issue, which involved the use of pesticides, was resolved in the early 1990s. Reintroduced falcons may disperse into other parts of the NEP area or even outside the NEP area. We believe that the frequency of movements outside the NEP area is likely to be very low based on the history of falcon reintroduction in Texas (Burnham *et al.* 2002), and the fact that the NEP area is large, spanning two entire States, while the reintroduction area is a relatively small portion. Any falcons outside the NEP area will be considered endangered under the Act. Any falcons that occur within the NEP area will be considered part of the NEP and will be subject to the protective measures in place for the NEP. The decreased level of protections afforded to falcons that cross into the NEP is not expected to have any significant adverse impacts to the wild population, since we do not anticipate this to occur very often.

(h)*Protection of Falcons:* We will reintroduce falcons in a manner that provides short-term protection from natural predators and human-related sources of mortality. Reintroduction methods designed to discourage predators include tall hacking towers as artificial nests and full-time biologists to feed and protect the young falcons and reduce natural mortality. Reintroducing falcons in areas with less human activity and development will minimize human-related sources of mortality, such as from collisions. Should causes of mortality be identified, we will work with the private landowners or agency land managers to try to correct the problem.

(i)*Potential for Conflict with Natural Recolonization of Falcons:* Natural ( *i.e.* , unaided) falcon recolonization of New Mexico and Arizona would be dependent on dispersing falcons from Mexico, Texas, or possibly unknown nesting pairs within the United States. We do not consider the unaided recolonization of falcons in the NEP area a likely occurrence for a number of reasons. The half-century absence of falcons in Arizona and New Mexico indicates that the Chihuahua, Mexico, falcon population is not likely to recolonize New Mexico and Arizona with sufficient numbers to establish a population in the foreseeable future. The low fledging success in Chihuahua and lack of significant expansion of that population since observations first began in 1992 (Montoya *et al.* 1997; Marcas-Duarte *et al.* 2004; Young *et al.* 2004; Juergens and Heinrich 2005) suggest that birds from Chihuahua are not likely to provide enough dispersers to populate New Mexico. Furthermore, the only birds that are known to be currently nesting in southern Texas are beyond the average dispersal distance for falcons. Natal dispersal to eventual breeding sites may be localized (Burnham *et al.* 2002). The longest known falcon dispersal distance is 250 km (155 mi) (Burnham *et al.* 2002), whereas the straight-line distance from currently breeding falcons near Brownsville, Texas, to Carlsbad, New Mexico, is approximately 973 km (605 mi), much further than any documented dispersal by falcons. It is possible, though unlikely, that individual captive-bred falcons or their progeny from west Texas could disperse into the NEP area. The majority of falcon reintroductions in west Texas are farther than 193 km (120 mi) from suitable habitat in New Mexico, and tall mountains separating the two regions may provide an obstacle to falcon migration. The Guadalupe Mountains span the border between Texas and New Mexico and rise to heights of 8,749 feet. Falcon reintroductions in west Texas only began in 2002, and as expected, there has not yet been any documented breeding by these reintroduced falcons. Furthermore, there have been no detections in New Mexico of falcons that were banded at west Texas reintroduction sites, and all of those reintroduced falcons should be banded. We do not consider the presence of the successful breeding pair in 2002 in Luna County to represent a population. The frequency and number of falcons in recent New Mexico sightings would, at that pace, be very unlikely to result in natural recolonization. Although there may be occasional falcon dispersal movements from Mexico to New Mexico, we do not believe this will lead to the establishment of a viable population within New Mexico. The population in Mexico has been known to exist since 1992, and likely existed prior to that; however, there has only been one known successful nest in the entire NEP area in over 50 years. Given the lack of a falcon population in the reintroduction area, and the low probability that falcons from Chihuahua, Mexico, can recolonize New Mexico, we believe that reintroductions are needed in order to establish a resident falcon population in the grasslands in the United States.

(j)*Public Awareness and Cooperation:* We will inform the general public of the importance of this reintroduction project in the overall recovery of the falcon. This designation will provide greater flexibility in the management of reintroduced falcons. NEP designation is necessary to secure needed cooperation of the States, landowners, Federal agencies, and other interests in the NEP area. For reasons stated, despite the relative success of the falcon releases in Texas, where there is relatively little public land, we believe the Safe Harbor Agreements used to release falcons in Texas are not the best mechanism for establishing falcons in New Mexico and Arizona. Safe Harbor Agreements can only be developed for private land owners, and the reintroduction area in New Mexico includes a vast amount of public land. Summary of Comments and Recommendations We requested written comments from the public on the proposed NEP and draft environmental assessment in the proposed rule published on February 9, 2005 (70 FR 6819). We also contacted the appropriate Federal, State, and local agencies, tribes, scientific organizations, and other interested parties and invited them to comment on the proposed rule. The initial comment period was open from February 9, 2005, to April 11, 2005. A second comment period was open from September 16, 2005, through November 15, 2005, to solicit comments on the draft monitoring plan and to announce the dates, locations, and times of the public hearings (70 FR 54701). In conformance with our policy on peer review, published on July 1, 1994 (59 FR 34270), we solicited opinions from six expert ornithologists who are familiar with this species to peer review the proposed rule. Three of the six peer reviewers submitted comments; the others did not. Their comments are included in the summary below. We reviewed all comments received from the peer reviewers, State agencies, and the public for substantive issues and new information regarding the proposed NEP. Substantive comments received during the comment period have either been addressed below or incorporated directly into this final rule. The comments are grouped below as either peer review, State, or public comments. Peer Review Comments

(1)*Comment:* While a small population of falcons exists in southeastern Chihuahua, Mexico, there is very little evidence of a tendency towards natural reestablishment in the United States. Despite arguments to the contrary, the occasional appearance of a vagrant or a nesting pair does not forecast reestablishment and certainly not the existence of a viable population. *Our Response:* We agree with the commentor that any significant natural re-colonization of habitats in Arizona and New Mexico would likely take decades, if it occurred at all, because the reproductive rate of the population in Mexico is low, and this population is not significantly expanding, possibly due to extended drought (Burnham *et al.* 2002).

(2)*Comment:* Aplomado falcons are colonizing New Mexico and Arizona on their own, as part of a natural range expansion. *Our Response:* Aplomado falcons are not likely to naturally recolonize in significant numbers. Please see our response to comment 1 and information under section 2 (“Biological”) of the Background section, above.

(3)*Comment:* Designation of an experimental population would hinder policy protections for naturally colonizing birds. *Our Response:* Birds that naturally recolonize areas in New Mexico will have reduced protections under the NEP; however, birds are not likely to naturally colonize in significant numbers. Thus, the benefits to falcon recovery of having large numbers of birds reintroduced is much greater than the potential effect of reducing protection for very few naturally colonizing individuals. In addition, all falcons will still be protected from direct intentional taking ( *e.g.* , hunting of falcons), and we anticipate little conflict with most otherwise lawful activities occurring in the NEP ( *e.g.* , grazing that uses best management practices). There has been only one reported conflict, which was resolved in the early 1990s, between human activities and falcons in Texas, where 1,142 falcons have been released over the course of 20 years (Burnham *et al.* 2002; Bond 2005; Jenny 2005; Robertson 2006). The areas that falcons inhabit on private lands with Safe Harbor Agreements in Texas are more densely populated by people than the public lands in New Mexico. Therefore, if conflicts are occurring, they would be detectable in Texas, and we have had no reported conflicts after the one in the early 1990s.

(4)*Comment:* One peer reviewer summarized the proposal as “biologically sound, politically tenable, but ethically irresponsible.” The reviewer asserts that limited recovery funds should be spent on higher priority species ( *i.e.* , species with lower recovery priority numbers under the Service's Recovery Priority Guidelines). *Our Response:* As we stated in the Recovery Priority Guidelines, “the priority systems presented must be viewed as guides and should not be looked upon as inflexible frameworks for determining resource allocations (48 FR 43098).” Many other factors, including landowner cooperation, likelihood of success of projects, public cooperation, and partner contributions, may play into the decision to focus on specific species or actions. The falcon reintroductions discussed in this rule are supported by all of these factors.

(5)*Comment:* Restoration of the falcon should occur within the natural predator community of the reintroduction area. Native predators ( *e.g.* , great-horned owls) should not be killed to protect released falcons. *Our Response:* The release protocols have been modified over time and include carefully chosen nest sites and use of nest boxes to minimize conflict with natural predators. The Service has no intention of killing native predators to benefit falcon releases. State Comments

(6)*Comment:* In general, the States of Arizona and New Mexico supported the proposed rule. One State agency suggested we develop a 10(j) population that would also allow for naturally occurring falcons ( *i.e.* , experimental status individuals will only be recognized outside areas that overlap with naturally occurring individuals) (50 CFR 17.80). Such a rule could also include zones for incremental State-wide expansion of the 10(j) population based upon an annual review by the Service and stakeholders. *Our Response:* The incremental designation proposal would likely not increase recovery benefits to the falcon for two reasons. First, falcons have the capability to move about the landscape easily and there would likely be frequent movements between NEP areas and areas without this designation within New Mexico. Therefore, the suggested scenario would create a very complicated regulatory patchwork, as the same falcons move into and out of NEP areas, and thereby became subject to changed regulations under the Act. Second, we do not anticipate that falcons will require the protections of full endangered status in order to recover in New Mexico and Arizona. We believe that designating both States as NEP areas relieves concerns of landowners and managers regarding land-use restrictions, and will lead to more sites for reintroductions and faster recovery for the subspecies. Public Comments Issue 1: Procedural and Legal Compliance

(7)*Comment:* The Service should designate critical habitat for the falcon, rather than designating a 10(j) population. If you finalize the proposed rule, then a critical habitat designation would be precluded and little to no regulatory protections would remain for occupied or unoccupied habitat. *Our Response:* The role that designation of critical habitat plays in protecting habitat of listed species, however, is often misunderstood. There are significant limitations on the regulatory effect of designation under ESA section 7(a)(2). In brief,

(1)Designation provides additional protection to habitat only where there is a Federal nexus;

(2)the protection is relevant only when, in the absence of designation, destruction or adverse modification of the critical habitat would in fact take place (in other words, other statutory or regulatory protections, policies, or other factors relevant to agency decision-making would not prevent the destruction or adverse modification); and

(3)designation of critical habitat triggers the prohibition of destruction or adverse modification of that habitat, but it does not require specific actions to restore or improve habitat. We believe it is not likely that falcons will naturally recolonize areas in Arizona and New Mexico in the near future even though there is ample suitable habitat to support falcons. Because there is available habitat, but virtually no naturally occurring falcons, we believe that releases under a 10(j) rule are more beneficial to long-term falcon conservation than designation of critical habitat.

(8)*Comment:* The proposed rule violates the ecosystem protection purposes identified in section 2(b) of the Act. *Our Response:* We believe that releasing falcons under the section 10(j) provision of the Act is the most appropriate way to achieve conservation for this species, which has shown a remarkable ability to coexist with many human activities, and that this action is consistent with the intents and purposes of the Act. Falcon reintroductions are intended to return a missing predator to the grassland ecosystems to which it naturally belongs, and this should benefit ecosystem functioning.

(9)*Comment:* Does the 10(j) rule remove all section 7 responsibilities? *Our Response:* For the purposes of section 7 of the Act, we treat NEPs as threatened species when the NEP is located within a National Wildlife Refuge or a unit of the National Park System, and therefore section 7(a)(1) and the consultation requirements of section 7(a)(2) of the Act apply in these units. When NEPs are located outside a National Wildlife Refuge or unit of the National Park System, for the purposes of section 7 of the Act we treat the population as proposed for listing and only two provisions of section 7 would apply: Section 7(a)(1) and section 7(a)(4). In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(1) requires Federal agencies to use their authorities to further the conservation of listed species. Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a proposed species. The results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities.

(10)*Comment:* One commenter noted that if the proposed rule is finalized, the falcon would be treated as a species proposed for listing on BLM or DOD lands. The agencies would only be required to confer on actions that may jeopardize the species. If the population is deemed nonessential, the jeopardy threshold would never be reached, indicating that conferences would be an administrative task with no protection for the falcon. The Service should recognize that the BLM would no longer consult on many activities previously considered to be significant threats to falcon habitat such as oil and gas development, livestock grazing, military operations, or pesticide use. In fact, under the current nonessential experimental population proposal, the BLM could authorize a road or pipeline that destroys an occupied falcon nest without the need for an incidental take permit. *Our Response:* Consultation under section 7(a)(2) is only required for Federal projects that may affect listed species. It is unlikely that a Federal action would affect a significant number of falcons at the present time because the recent falcons sighted in New Mexico appear to be transients and there is a near absence of any falcon sightings in Arizona. Therefore, designating the reintroduced population as non-essential will not significantly change current practices regarding consultation under 7(a)(2), on areas outside of the National Wildlife Refuge and National Parks. Since the falcon will now be treated as a species proposed for listing, sections 7(a)(1) and 7(a)(4) will apply to Federal actions. The falcon will be treated as a threatened species on BLM and DOD lands for purposes of section 9 of the Act. Through section 4(d) of the Act, we have greater discretion in developing management programs and special regulations for threatened species than we have for endangered species. Section 4(d) of the Act allows us to adopt whatever regulations are necessary to provide for the conservation of a threatened species. While it is true that consultation requirements are lessened, we believe that the incidental take associated with otherwise lawful activities will not pose a long-term threat to falcon conservation under this rule, as most activities that occur in the 10(j) area are compatible with falcon recovery. Furthermore, Federal agencies will continue to analyze the impacts of their actions under NEPA. In addition, birds will continue to be reintroduced into New Mexico, which will provide some buffer to the population against individual birds lost to incidental take. A special rule under section 4(d) of the Act is included in this final action, and it authorizes unknowing or incidental take of falcons ( *i.e.* , take that is incidental to an otherwise lawful activity). Direct take for research or educational purposes would require a section 10 recovery permit. Knowing take ( *e.g.* , shooting) or take due to negligence will not be permitted. Additional information about the special rule can be found under the Final Regulation Promulgation section below.

(11)*Comment:* How will beneficial activities ( *e.g.* , prescribed fire, fencing, bank stabilization, storm water runoff control) be handled under section 7 in the 10(j) area? *Our Response:* These actions will be handled like any other projects subject to section 7 in the NEP area. Please see our response to comment 9 above.

(12)*Comment:* One commenter was concerned that lessees and allotment holders have to remove cows from allotments during nesting season. *Our Response:* In our experience with reintroducing falcons in south Texas, livestock grazing using best management practices has been compatible with successful nesting by falcons. It is possible that the conference opinions for grazing on Federal lands would recommend additional grazing guidelines; however, these measures are not mandatory, and it would be up to the Federal agency and lessee or allotment holders to implement at their discretion.

(13)*Comment:* The final rule should confirm that military operations ( *e.g.* , low-level overflight, bombing and gunnery activities, target placement) will not be affected by the 10(j) designation, even if occurring over National Park Service or National Wildlife Refuge lands. *Our Response:* As stated in our response to comment 9, if aplomado falcons are found within a National Wildlife Refuge or unit of the National Park System and there may be impacts from military activities, section 7 consultation may be required. Any military operations that may affect the 10(j) falcons would only involve conferencing with the military and recommended actions, if any, would be at the discretion of the military to implement.

(14)*Comment:* In order to streamline future conference opinions, the final rule should provide authorization to Federal agencies to permit habitat destruction. *Our Response:* Section 10(j) of the Act explicitly states that for the purposes of section 7, the species designated as non-essential will be considered a proposed species. Federal agencies will have an obligation to confer (rather than consult) with the Service on proposed activities that are likely to jeopardize the continued existence of the falcon. The results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities.

(15)*Comment:* The Service should clarify the terms “willing landowner or manager” as they relate to one of the criteria in the selection of release sites. The term “manager” should also refer to an allotment permit holder in the case of Federal or State lands. *Our Response:* We will attempt to work with both land managers and allotment permit holders; however, we do not have authority over allotment permit holders or authority to require land managers to seek allotment permit holder approval of various projects. Issue 2: Biological Issues

(16)*Comment:* Many commenters recommended that we omit the reference to a specific numbers of pairs, increase the number of pairs, and/or clarify the definition of “population” we used in the 10(j) proposed rule due to the lack of scientific agreement on defining this term. That definition was, “a minimum of two successfully reproducing falcon pairs over multiple years.” One commenter suggested that we instead define a population as “sustained and predictable presence of more than negligible numbers of successfully reproducing individuals over a period of many years.” *Our Response:* We have clarified the definition of “population” used in the proposed rule in the “Recovery Efforts” section of the Background.

(17)*Comment:* Naturally occurring falcons already exist on the landscape in New Mexico and adjacent northern Chihuahua, Mexico ( *e.g.* , see Young *et al.* 2002, 2004; Meyer and Williams 2005). There have been about 45 credible sightings of falcons in New Mexico since 1990, within 3 to 6 credible observations per year since the late 1990s. The territory in Luna County, New Mexico, has been occupied from 2000 to 2005. Falcons have also recently been observed crossing the United States-Mexico border. The Service has not considered all of this new information. Therefore, a 10(j) rule does not seem to be a reasonable approach for falcon recovery. *Our Response:* In the “Recovery Efforts” section of the Background, we clarify the reasons why we do not believe that a falcon population exists in Arizona and New Mexico. In the case of the falcon,

(1)This subspecies has been known to disperse hundreds of kilometers,

(2)it would be virtually impossible to preclude naturally occurring individual falcons from intermingling with the experimental population, and

(3)there has been only one known pair that has reproduced (and only one time) in over 50 years within the designated experimental area. Therefore, we identified the experimental population as all falcons found within the experimental area, including reintroduced falcons and any lone dispersers and their offspring. We believe this is the best manner by which to manage the falcon reintroduction program to achieve species recovery.

(18)*Comment:* In the proposed rule, there is an inaccurate statement that the proposed nonessential experimental population is geographically isolated from existing falcon populations in Mexico and Texas by a sufficient distance to preclude contact between populations. In fact, New Mexico is easily within the documented flying ( *i.e.* , dispersal) distance of these falcon populations. *Our Response:* Even though falcons from Mexico may enter New Mexico occasionally, the 10th Circuit Court in the wolf case ( *Wyoming Farm Bureau Federation* v. *Babbitt* ) supported the use of the 10(j) designation under very similar circumstances of occasional, low frequency contact. In over 50 years, we know of only one pair of successfully reproducing falcons in New Mexico. This one occurrence does not indicate that there is self-sustaining, regular interbreeding occurring between falcons in New Mexico and those in Mexico. The single pair of falcons that successfully reproduced once in 2002, after a 50-year absence, is not self-sustaining, not a group, and not in common spatial relationship with the group of approximately 25 to 35 breeding falcon pairs in the Mexican State of Chihuahua, 160 km (100 mi) south of the United States border. These Mexican birds appear to be self-sustaining and interbreeding, even though the population is not expanding. In addition, there is a significant gap between the location of the pair in the United States and the most northern breeding pair in Chihuahua, and even more distance to the main cluster of breeding pairs there. Please also see the “Recovery Efforts” section of the Background for additional discussion on this subject. The only birds that are known to be currently nesting in Texas are beyond the average dispersal distance for falcons. Natal dispersal to eventual breeding sites may be localized (Burnham *et al.* 2002). The longest documented falcon dispersal distance is 250 km (155 mi) (Burnham *et al.* 2002). A straight-line distance from breeding falcons near Brownsville, Texas, to Carlsbad, New Mexico, is 973 km (605 mi), much farther than any documented falcon dispersal. It is possible, though unlikely, that individual captive-bred falcons or their progeny from west Texas could disperse into the NEP area. The majority of falcon reintroductions in west Texas are farther than 193 km (120 mi) from suitable habitat in New Mexico, and tall mountains separating the two regions may provide an obstacle to falcon migration. The Guadalupe Mountains span the border between Texas and New Mexico and rise to heights of 8,749 feet. Falcon reintroductions in west Texas began in 2002, and as expected, there has not yet been any documented breeding by these reintroduced falcons. Furthermore, there have been no detections in New Mexico of falcons that were banded at west Texas reintroduction sites, and all of these reintroduced falcons should be banded.

(19)*Comment:* The Service speculated about falcon numbers in New Mexico without conducting comprehensive surveys of potential falcon habitat. Additional falcons probably would be documented with additional surveys. *Our Response:* Over the past decade, widespread formal surveys have been conducted in suitable falcon habitats in southern New Mexico. Please refer to the discussion on survey results under the Biology portion of the Background section.

(20)*Comment:* There is no justification for releasing such a large number of falcons in New Mexico, especially given the current increasing status of native birds and finite amount of suitable habitat. *Our Response:* Young *et al.*

(2005)indicated that there are approximately 9,060 km 2 (5,600 mi 2 ), or 906,000 ha (2,238,766 ac), of suitable habitat in New Mexico. We believe there is sufficient suitable habitat for falcon recovery in New Mexico. Montoya

(1995)estimated that 1 falcon pair required 4,300 ha (10,625 ac) in Chihuahua, Mexico. If this size requirement for nesting territory also applies to the estimated quantity of suitable habitat in New Mexico, the State could support up to 200 pairs of falcons. Much of this suitable habitat occurs in Otero Mesa, Fort Bliss, White Sands Missile Range, the Jornada Plain (Armendaris Ranch and Jornada del Muerto), and the southwestern corner, or boot-heel, of New Mexico south of Interstate 10. Although releases will occur only in New Mexico, falcons will likely colonize suitable habitat in southeastern Arizona, further increasing the number of falcons inhabiting Chihuahuan Desert grasslands (Montoya 1995).

(21)*Comment:* The Tenth Circuit Court of Appeals found that Congress gave the Service considerable discretion in defining the term “experimental population” as it related to the establishment of an experimental population of wolves in the northern Rockies. In that case, the occasional presence of individual animals without any sustained successful reproduction appeared to be consistent with the purposes of a 10(j) population. The same logic should be applied to present rulemaking. *Our Response:* We agree and discussed this court decision in the “Recovery Efforts” section of the Background, and in our responses to comments 17, 18, and 19.

(22)*Comment:* The proposed rule is not consistent with Service policy on 10(j) populations published in the **Federal Register** (49 FR 33885). As discussed in the policy, the proposal “cannot reduce protections for native fish, wildlife, and plants that expand naturally into areas designated as experimental (49 FR 33885).” The proposed rule appears to be a short-cut around natural falcon recovery that eliminates meaningful habitat protections with voluntary unenforceable measures. *Our Response:* Please see our responses to comments 17, 18, and 19.

(23)*Comment:* It is not appropriate to conclude that in the long-term the Chihuahua population of falcons would not be able to produce dispersing falcons under improved conditions. Please consider evaluating Macías-Duarte

(2004)and Jenny *et al.*

(2004)in relation to Burnham *et al.*

(2002)and Montoya *et al.* (1997). *Our Response:* We evaluated the results in Macías-Duarte (2004), Jenny *et al.* (2004), Young *et al.* (2004), and Juergens and Heinrich (2005), and did not find information that would indicate that the population in Chihuahua has significantly expanded since its discovery in 1992. We found that there appears to be general agreement among the authors that the number of pairs has been fairly stable and that, in most years, productivity of the pairs has been low. Furthermore, we have no authority to improve conditions for the falcons in Mexico. Recolonization has not occurred in New Mexico since the birds were discovered in Chihuahua, and there is no indication that recolonization is occurring now, with only one known pair successfully reproducing one time in 2002 in New Mexico.

(24)*Comment:* All released falcons should be marked to ensure that dispersal of birds does not trigger additional regulations to public and private lands. *Our Response:* In order to ascertain the success of the reintroduction effort, The Peregrine Fund will annually survey the area surrounding releases to locate surviving birds. Falcons will be located and identified and the number of territorial pairs will be recorded. If nesting is documented, then nest success will be assessed and as many chicks will be banded as possible. All released falcons and their progeny will be banded to the extent possible. The Peregrine Fund will coordinate with the Service to develop a banding plan that complements banding efforts in Mexico and Texas. The NEP designation will cover any falcon in Arizona or New Mexico. Therefore, no additional regulations will be triggered whether a falcon is banded or unbanded. If a falcon should leave the NEP area, it would be considered fully endangered under the Act, unless it is found in a location where another designation exists or there is a Safe Harbor Agreement in place.

(25)*Comment:* The Service should describe that a mixed designation which includes both experimental and nonexperimental ( *i.e.* , full protections under the Act) population areas for New Mexico and Arizona will be confusing and difficult to implement. A nonessential experimental population of falcons will assist in gaining support for the conservation of the falcon that might not exist otherwise. *Our Response:* We agree and have incorporated these points into the “Recovery Efforts” section of the Background above.

(26)*Comment:* The Service should refrain from releases of captive-raised birds until there is a better understanding of the habitat requirements and genetics of the naturally occurring falcons. Any released falcons should be genetically appropriate for the Chihuahuan grassland population. The Service should conserve the native population of falcons, and not introduce individuals with a different genetic composition ( *e.g.* , from Veracruz, Tabasco, Campeche, and Chiapas, Mexico, outside of the Chihuahua Desert) or behavioral differences that may reduce the fitness of these locally-adapted birds. *Our Response:* Please refer to the discussion found in the “Genetic Variation” portion of the Management section. No new genetic information was provided to the Service during either of the two public comment periods for this proposal.

(27)*Comment:* Several commenters suggested that we develop a 10(j) population that would also allow for naturally occurring falcons ( *i.e.* , experimental status individuals would only be recognized outside areas that overlap with naturally occurring individuals) (50 CFR 17.80). *Our Response:* Please see our response to State comment 6.

(28)*Comment:* Please explain why the Service does not support the selection of the alternative that implements Safe Harbor Agreements for the falcon. This would achieve landowner cooperation, achieve species recovery, and continue habitat protections. *Our Response:* Please refer to the discussion found in the “Recovery Efforts” portion of the Background section.

(29)*Comment:* Explain why the population of reintroduced falcons would not be essential to the continued existence of the species. *Our Response:* The proposed experimental falcon population will be designated NEP because:

(1)There are established populations in Mexico and a rapidly increasing population in south Texas;

(2)reintroductions will continue in west Texas;

(3)the Boise, Idaho, captive population is producing enough offspring to both maintain the captive flock and provide falcons for release; and

(4)the possible failure of this action would not appreciably reduce the likelihood of survival of the subspecies in the wild. The NEP designation allows for regulatory flexibility for management that contributes to the conservation of falcons, which makes the reintroduction of falcons in New Mexico less controversial to land managers, and should result in a larger number of release sites and more widespread reintroductions. Therefore, we believe the use of the NEP should be the fastest way to successfully establish a falcon population in New Mexico and Arizona. We have concluded this reintroduced population to be nonessential to the continued existence of the species according to the provisions of section 10(j) of the Act for the following reasons:

(a)With at least three populations, one in eastern Mexico, a second in northern Chihuahua, Mexico, and a third becoming established in southern Texas, the experimental population is not essential to the continued existence of the species. The threat of extinction from a single catastrophic event has been reduced by a gradual increase of the southern Texas and captive populations. Thus, loss of the experimental population will not appreciably reduce the likelihood of falcon survival in the United States; and,

(30)*Comment:* Nonessential experimental populations are usually considered where there is opposition from private landowners to an endangered species reintroduction. The majority of potential falcon habitat in New Mexico is managed by the Forest Service, BLM, and DOD. You have not demonstrated in the proposed rule or environmental assessment

(EA)that there is opposition by private landowners or the general public to a reintroduction on the small amount of private lands. Even if there were, a reintroduction program could accomplish the same objectives by using Safe Harbor Agreements for the private landowners, as was accomplished in south Texas. *Our Response:* Comments received during the public comment periods from public agencies, private citizens, and landowners demonstrated that there would be a great deal of opposition to reintroducing falcons in Arizona and New Mexico without the 10(j) designation. The 10(j) designation gives us regulatory flexibility, which is beneficial when trying to reintroduce a new population.

(31)*Comment:* Falcon recovery will have an impact on other species. *Our Response:* Falcons historically occupied this desert habitat, and the plants and animals that exist there evolved with this predatory bird. Thus, through falcon recovery, we are aiding in restoration of this desert ecosystem. In addition, we do not expect any significant impact to any other listed or unlisted species to result from falcon recovery. As predators, falcons require large home ranges in order to have adequate amounts of available prey (Keddy-Hector 2000); therefore, they would not occupy suitable habitat in large numbers. They are anticipated to be widely distributed in low numbers over the suitable habitat in New Mexico and Arizona. Furthermore, falcons are generalists and will consume a wide variety of insects, small mammals, reptiles, and small to medium-sized birds. Therefore, falcon recovery is not anticipated to negatively affect other sympatric species.

(32)*Comment:* If DDT is still used in Mexico, then it does not seem logical to start a recovery process on the United States at the Mexico border only to fail because of the use of DDT in Mexico. *Our Response:* We have no knowledge of widespread use of DDT in Mexico, as its use was banned in 2000. In addition, we have seen a significant decrease in the concentrations of DDT remaining in the United States since its use was banned in 1972, leading to delisting of the American peregrine falcon in 1999 (64 FR 46541), and the currently proposed delisting of the bald eagle (64 FR 36454; 71 FR 8238; 71 FR 28293). We anticipate that sufficient numbers of falcons will reside and hunt in suitable habitat in New Mexico and Arizona such that any residual DDT remaining in Mexico will not preclude falcon recovery in the United States.

(33)*Comment:* Habitat degradation was one of the primary threats to the species when it was listed as endangered. Recent information indicates that habitat and avian prey are important determinants of falcon habitat ( *e.g.* , Macias-Duarte *et al.* 2004; Meyer and Williams 2005). *Our Response:* The intense overgrazing that resulted in shrub encroachment in grasslands has moderated, with widespread implementation of improved range management techniques, including decreased stocking rates, stock rotation, and prescribed burning (Archer 1994; Heady 1994; Burnham *et al.* 2002). In addition, DDT use was banned in the United States in 1972 and in Mexico in 2000. Therefore, falcon reintroductions are considered appropriate because habitat threats are continuing to be reduced. In addition, as described in this final rule, reintroduction sites will be carefully selected to optimize habitat suitability, and falcons are known generalists and will not be dependent on the availability of any particular type of prey.

(34)*Comment:* Please explain how the reintroduction of falcons is compatible with existing land use practices ( *e.g.* , livestock grazing, oil and gas development), yet the Service has a documented history of finding these same practices are threats to the species (Service 1990, 51 FR 6686). *Our Response:* In the 1990 recovery plan (and the 1985 and 1986 listing rules) for the falcon, the causes of decline for the subspecies included brush encroachment and agricultural development that destroyed grassland habitat; channelization of desert streams that destroyed wetland communities that provided habitat for avian prey; and pesticide contamination, such as by DDT. On the other hand, livestock grazing that uses best management practices has been recognized as compatible with nesting falcons (Burnham *et al.* 2002), and oil and gas development was not mentioned as a threat in either the recovery plan or listing rules. Existing land use practices may be a threat to individuals of a species ( *i.e.* , may result in “take” of individuals under previous regulations); however, we believe the existing land use practices are compatible with overall conservation efforts for the subspecies as a whole. This has been demonstrated by the successful recolonization of falcons reintroduced in Texas over the past two decades, where there has been only one reported conflict with existing land use practices during that period of time and it was resolved in the early 1990s (Burnham *et al.* 2002; Bond 2005; Jenny 2005; Robertson 2006).

(35)*Comment:* Initiating another reintroduction program in the Chihuahuan Desert is not prudent before the outcome of the program in west Texas is assessed. The Service should plan on conducting such an assessment. *Our Response:* As we discussed previously in this final rule, we are designating the population of falcons in New Mexico and Arizona as experimental and will evaluate the success of our reintroduction program every 5 years. The releases in south Texas have demonstrated success toward the recovery of the falcon in the United States; and therefore, we do not believe it would be beneficial for falcon recovery to postpone this reintroduction effort to assess the success of the program in west Texas.

(36)*Comment:* The Service should not base the EA and proposed 10(j) population on an outdated recovery plan. The Service should establish a formal recovery team and update the falcon recovery plan prior to finalizing the 10(j) rule and releasing birds. *Our Response:* A current recovery plan is not required in order to move forward with recovery actions, including any associated regulations. While we would like to update the recovery plan, we do not feel it is necessary to complete a revision prior to moving forward with this 10(j) rule. Falcon reintroductions such as these were recommended in the 1990 recovery plan, and we are implementing these recommendations. Furthermore, the recovery plan provides guidelines for the recovery process, and, in combination with the best available scientific information, we will continue to evaluate the application of these guidelines to the reintroduction process as needed in the future.

(37)*Comment:* We received comments about agreements or memoranda of understanding with land managers that ranged from:

(1)The Service should have a signed memorandum of understanding with landowners prior to finalization of the 10(j) rule in order to ensure habitat guidelines are followed, to

(2)agreements or memoranda of understanding with land managers should not be required as they create undue burden on land managers. *Our Response:* We do not anticipate that there will be conflicts between falcon reintroduction and current land use practices. Therefore, at present, we do not feel that agreements or memoranda of understanding with landowners are necessary to provide suitable habitat for falcons. We will choose falcon reintroduction sites that meet the following criteria:

(1)Within or in proximity to potentially suitable habitat, including open grassland habitats that have scattered trees/shrubs/yucca for nesting and perching;

(2)supporting available prey for falcons ( *e.g.* , insects, small to medium-sized birds, and rodents);

(3)with minimal natural and artificial hazards ( *e.g.* , predators, open-water tanks) and potential hazards that can be minimized where practical;

(4)with access for logistical support;

(5)with a large extent of potentially suitable habitat surrounding a release site and its proximity to other similar habitats; and

(6)with a willing landowner or land manager. We will evaluate the success of these criteria through our 5-year review process, and if indicated, we will have the option of executing agreements or memoranda of understanding with willing landowners in the future.

(38)*Comment:* The EA and proposed rule do not consider that natural recolonization is already occurring and could be facilitated by focusing scarce funding on habitat restoration, rather than releasing captive birds. Enhancing habitat for falcons is a better use of funds for the long-term recovery of the species and establishment of a naturally occurring population. *Our Response:* We believe there is ample suitable habitat to support falcons and that focusing on habitat enhancement is not the best use of funds. Because there is available habitat, but limited numbers of naturally occurring falcons, we believe reintroductions will serve a key role in the recovery of the falcon. Furthermore, the falcon reintroductions that result from this rule will have a large partnership component, which will help spread expenses among many entities. Under the 10(j) designation, section 7(a)(1) still applies and requires all Federal agencies to use their authorities to conserve listed species. Therefore, Federal agencies can still fund habitat enhancement projects for falcons in accordance with their 7(a)(1) responsibilities. Issue 3: The Monitoring Plan

(39)*Comment:* The Service should establish a long-term monitoring program that addresses nesting success, prey availability, vegetation, and causes of mortality. You should also develop an adaptive management process that includes stakeholders and a large-scale landscape conservation strategy. *Our Response:* The short-term monitoring described in the monitoring plan includes the documentation of nesting, nesting success, vegetation, and other habitat attributes of nest sites and territories. Recommended long-term monitoring activities include documentation of other avian species, including other raptors and potential prey species of falcons. As information becomes available from these efforts, we will be able to design more refined long-term monitoring efforts. The monitoring plan provides for an adaptive management process through annual stakeholder meetings and evaluation reports to review project data to determine if refinements to the program are needed.

(40)*Comment:* The Service should provide a timeframe to implement and evaluate this approach to recovering the falcon. *Our Response:* Annual stakeholder meetings will be conducted to review project data to determine if refinements to the program are needed. We will use the best scientific and commercial data available, including, but not limited to, results from the monitoring plan and stakeholder meetings to develop interim objectives to assist in measuring the success of the program and to prepare 5-year evaluations of the restoration program. As indicated in section 5 (“Reintroduction Procedures”) of the Background, we anticipate releasing falcons for 10 years or more. Although we have reason to expect success from this program, based on experiences in Texas, it is acknowledged to be a truly experimental effort involving uncertainties that preclude the identification of a more precise timeframe for implementation.

(41)*Comment:* The 10(j) designation should have a quantifiable number of falcons as a recovery target or a date set to end the program if this program is not successful. *Our Response:* Section 10(j) and its implementing regulations do not have a requirement that we specify a population target or date, only that the release will further the conservation of the species. As stated in our response to comment 21, the best current estimate is that habitat in New Mexico is sufficient to support up to 200 pairs of falcons, and that Chihuahuan Desert habitat in Arizona may support additional individuals. We will evaluate the progress of the program through the annual meetings and reviews of the Peregrine Fund's annual reports, 2-year progress reports on agency Tier II monitoring efforts, and 5-year evaluations. Efforts under this 10(j) rule will cease when or if it is determined that the program no longer furthers the conservation of the falcon.

(42)*Comment:* There should be provisions for banding progeny of captive-reared birds to evaluate the reintroduction program. *Our Response:* We acknowledge the value of banding the progeny of captive-reared birds to evaluating the program. The monitoring plan provides in the post-release procedures that as many chicks as possible from successfully nesting falcons will be banded.

(43)*Comment:* Habitat conditions, particularly grassland birds that provide prey, should also be monitored. *Our Response:* As indicated in a response to an earlier comment, the monitoring plan includes assessments of habitat suitability and surveys, including surveys of other avian species that are potential prey for falcons.

(44)*Comment:* The Service has not ensured that monitoring native falcons will occur if non-mandatory surveys are subject to available funding. *Our Response:* We note that conservation efforts by us and our conservation partners are always subject to funding support by Congress, State legislatures, or private individuals and organizations. Although we have no guarantees about funding in future years, we have a reasonable expectation that our partners will be able to carry out the monitoring activities that they have identified as appropriate.

(45)*Comment:* The Service should include criteria and define the term “success” in the monitoring plan. *Our Response:* We will view the program as a success as long is it is furthering the conservation of the falcon. Although our best estimate is that habitat in New Mexico could potentially support up to 200 pairs of falcons, we anticipate that information gathered during the monitoring efforts will allow us refine our understanding of what is achievable in terms of conserving the falcon.

(46)*Comment:* Prey species are particularly important during the establishment of pair bonds and territories, which usually occur in late winter or very early spring. The breeding bird survey protocol should be used during this time of the year. Consider clarifying the methodology and timing for conducting prey base surveys. *Our Response:* We have adopted this recommendation and have added it to the monitoring plan's discussion of surveys of avian species.

(47)*Comment:* The monitoring plan should include a discussion of what data should be collected in a given situation. For example, documenting stick nests would be especially important, but should be evaluated in light of other management goals/objectives and priorities. *Our Response:* We believe that the information we specified is the most appropriate for beginning the monitoring effort. As information is gathered, special situations will be noted and appropriate modifications to our protocol will be adopted.

(48)*Comment:* The Service should evaluate key ecological factors to prioritize where management/recovery actions should be concentrated. These include variability of prey abundance, potential nest site availability, predator pressure, contaminant load, age and sex of dispersing falcons, and demography. *Our Response:* We will be using available information on the falcon, including a recently finalized assessment of falcon habitat (Young *et al.* 2005), in the selection of release sites. The monitoring plan includes the gathering of information on habitat suitability and on the presence of avian predators and prey.

(49)*Comment:* The 10(j) rule should be removed once the population is “self-sustaining,” and standard ESA protections resume. *Our Response:* The removal of a 10(j) listing of an NEP would first require a finding that the information on which the original “nonessential” determination was based had changed enough that the loss of the population would be likely to appreciably reduce the likelihood of survival of the species in the wild. We foresee little likelihood that success of reintroduction in the 10(j) area would occur while severe negative changes in the status of the falcon occurred elsewhere. Any change in the 10(j) listing would require us to engage in notice-and-comment rulemaking, including publishing a proposed rule in the **Federal Register** seeking public comment on that proposal (including, if requested, public hearings), and publishing a final determination in the **Federal Register** .

(50)*Comment:* The monitoring plan lacks sufficient performance measures. *Our Response:* We have added a statement to the monitoring plan indicating that, based on information gathered as monitoring proceeds, we will develop interim objectives to assist in measuring the success of the program. Even with prior experience in reintroducing this species, progress in the reintroduction effort cannot be predicted sufficiently to develop more detailed performance measures at this time. From our conservation efforts on this and other species, we know that it may take several years of effort before we can more clearly judge the likelihood of success of reintroduction. Information gathered as reintroduction proceeds will be used to evaluate progress on the program. Based on this information, we will consider more precise performance measures and adopt those that are likely to increase the likelihood of success of the program.

(51)*Comment:* How long will re-introduction efforts continue? *Our Response:* We anticipate releasing falcons for 10 years or more.

(52)*Comment:* The 10(j) rule should remain in place until the species is delisted. *Our Response:* Our intent is for the 10(j) rule to remain in place until the status of the species improves to a point where listing is no longer necessary, and the falcon can then be delisted.

(53)*Comment:* How will the delisting process proceed when the falcon population has reached a sufficient level? *Our Response:* Once the threats to the falcon have been reduced, and populations are self-sustaining, the Service will publish a proposed rule to delist the falcon in the **Federal Register** . There would be opportunities for the public to comment and request public hearings. Information gathered during the public comment period would be incorporated into our evaluation of listing status. If we were to determine that listing is no longer appropriate, a final rule delisting the falcon would then be published in the **Federal Register** .

(54)*Comment:* Will those involved in monitoring efforts always seek landowner and manager permission prior to entering private lands? *Our Response:* Yes. It is our policy that landowner approval will always be obtained either in writing or by record of telephone conversation prior to entering private lands. We also specify in our permits for work on listed species that the permit does not confer right to trespass, and that landowner permission must be obtained by the permittee. Our monitoring plan states that landowner consent either in writing or by record of telephone conversation is a prerequisite for data collection on private land.

(55)*Comment:* Falcons do not normally breed until they are 2 years old, not 3 years old as indicated on page 3 of the draft monitoring plan. *Our Response:* This correction has been incorporated into the final monitoring plan.

(56)*Comment:* The short-term monitoring section of the draft monitoring plan states that BLM will supply remote-sensing data. Only BLM in New Mexico will be supplying these data. *Our Response:* This correction has been incorporated into the final monitoring plan.

(57)*Comment:* A new version of the habitat assessment protocol, Attachment A of the monitoring plan, is available from the New Mexico Cooperative Fish and Wildlife Research Unit. *Our Response:* We have replaced Attachment A with the newer version. We have also added a statement to the monitoring plan that the information from the protocol is intended to be used to improve site selection for releases. Issue 5: Additional Comment

(58)*Comment:* The Service should support research, management, and outreach efforts on public and private lands for the falcon within its core breeding range in the Chihuahua desert grasslands, including adjacent Chihuahua, Mexico. *Our Response:* We agree and, with our partners, will attempt to support and/or coordinate these activities to the extent that we are able. Finding We followed the procedures required by the Act, NEPA, and the Administrative Procedures Act during this Federal rulemaking process. Therefore, we solicited public and peer reviewer comment on the proposed NEP designation. As required by law, we have considered all comments received on the proposed rule, the draft EA, and the draft monitoring plan before making this final determination. Based on the above information, and using the best scientific and commercial data available (in accordance with 50 CFR 17.81), the Service finds that creating a NEP of northern aplomado falcons and releasing them into the NEP area will further the conservation of the species. Effective Date We are making this rule effective upon publication. In accordance with the Administrative Procedure Act, we find good cause as required by 5 U.S.C. 553(d)(3) to make this rule effective immediately upon publication in the **Federal Register** . We expect that up to 140 falcons could be available for release in 2006 in New Mexico and western Texas (Juergens and Heinrich 2005). In order for this group of falcons to have the optimal amount of time to successfully reach independence, they will need to be reintroduced into the wild beginning in late spring and summer 2006 (Juergens and Heinrich 2005). Careful timing of the age for reintroducing falcons is important to increase their chances for successfully fledging and reaching independence (Sherrod *et al.* 1987). A 30-day delay would be contrary to the public interest because it would result in delay of reintroductions until spring of 2007, as falcons are most successfully reintroduced when they are several weeks old and this age cohort only occurs in late spring and summer each year (Sherrod *et al.* 1987). Required Determinations Section 7 Consultation A special rule under section 4(d) of the Act is included in this establishment of an experimental population under section 10(j) of the Act. A population designated as experimental is treated for the purposes of section 9 of the Act as threatened, regardless of the species’ designation elsewhere in its range. The Service is not required to consult on this special rule under section 7(a)(2) of the Act. The development of protective regulations for a threatened species are an inherent part of the section 4 listing process. The Service must make this determination considering only the “best scientific and commercial data available.” A necessary part of this listing decision is also determining what protective regulations are “necessary and advisable to provide for the conservation of [the] species.” Determining what prohibitions and authorizations are necessary to conserve the species, like the listing determination of whether the species meets the definition of threatened or endangered, is not a decision that Congress intended to undergo section 7 consultation. Regulatory Planning and Review (E.O. 12866) In accordance with the criteria in Executive Order 12866, this rule to designate NEP status for northern aplomado falcon in Arizona and New Mexico is not a significant regulatory action subject to Office of Management and Budget review. As described below, this rule will not have an annual economic effect of $100 million or more on the economy and will not have an adverse effect on an economic sector, productivity, competition, jobs, the environment, or other units of government. Therefore, a cost-benefit and full economic analysis will not be required. Following release, birds may use private or public lands adjacent to release areas. Because of the substantial regulatory relief provided by the NEP designation (no penalties for unintentional take or restrictions against land use), we do not believe the reintroduction of falcons will conflict with existing human activities or hinder public or private use of lands within the NEP area. Likewise, no governments, individuals, or corporations will be required to specifically manage for reintroduced falcons. This final rule will not create inconsistencies with other agency's actions or otherwise interfere with an action taken or planned by another agency. Federal agencies most interested in this rulemaking are the Bureau of Land Management and Department of Defense because they manage large areas of suitable falcon habitat within the NEP area. These agencies participated in the northern aplomado falcon working group and had the opportunity to participate in the development and review of the action finalized by this rulemaking and to ensure the action is consistent with their land management plans. Because of the substantial regulatory relief provided by the NEP designation, we believe that the reintroduction of northern aplomado falcons in the areas described will not conflict with existing human activities or hinder public utilization of the area. This rule will not materially affect entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients. Because there are no expected impacts or restrictions to existing human uses of the NEP area as a result of this rule, no entitlements, grants, user fees, loan programs, or the rights and obligations of their recipients are expected to occur. This rule does not raise novel legal or policy issues. Since 1984, we have promulgated section 10(j) rules for many other species in various localities. Such rules are designed to reduce the regulatory burden that would otherwise exist when reintroducing listed species to the wild. Regulatory Flexibility Act Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 804(2)), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare, and make available for public comment, a regulatory flexibility analysis that describes the effect of the rule on small entities ( *i.e.,* small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule will not have a significant economic impact on a substantial number of small entities. We are certifying that this rule will not have a significant economic effect on a substantial number of small entities. The following discussion explains our rationale. The area affected by this rule includes the States of Arizona and New Mexico. We do not expect this rule to have any significant effect on recreational, agricultural, or development activities within the NEP area because the NEP designation provides no restrictions on most Federal (see next paragraph for National Wildlife Refuges and units of the National Park System) and all non-Federal actions that may affect falcons. In addition, the special rule authorizes unknowing or incidental take of falcons ( *i.e.,* take that is incidental to an otherwise lawful activity). Direct take for research or educational purposes would require a section 10 recovery permit under the Act. Knowingly taking falcons ( *e.g.,* shooting) will not be permitted. The action will not affect the establishment of future hunting seasons or conservation actions approved for migratory bird species. The principal activities on private property near the initial release areas are agriculture and recreation. We believe the presence of the falcon will not preclude use of lands for these purposes. Because there will be no new or additional economic or regulatory restrictions imposed upon States, Federal agencies, or members of the public due to the presence of the falcon, this rulemaking is not expected to have any significant adverse impacts to recreation, agriculture, or any development activities. When NEPs are located outside a National Wildlife Refuge or unit of the National Park System, we treat the population as proposed for listing and only two provisions of section 7 would apply: section 7(a)(1) and section 7(a)(4). In these instances, NEPs provide additional flexibility because Federal agencies are not required to consult with us under section 7(a)(2). Section 7(a)(1) requires Federal agencies to use their authorities to further the conservation of listed species. Section 7(a)(4) requires Federal agencies to confer (rather than consult) with the Service on actions that are likely to jeopardize the continued existence of a proposed species. The results of a conference are advisory in nature and do not restrict agencies from carrying out, funding, or authorizing activities. When the NEP is located within a National Wildlife Refuge or National Park, we will treat the reintroduced falcons as threatened under the Act, and therefore the consultation requirements of section 7(a)(2) will apply on these Federal lands. Unfunded Mandates Reform Act (2 U.S.C. 1501 *et seq.* ) In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 *et seq.* ): 1. On the basis of information contained in the “Required Determinations” section above, this rule will not “significantly or uniquely” affect small governments. We have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 *et seq.,* that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. A Small Government Agency Plan is not required. As explained above, small governments will not be affected because the NEP designation will not place additional requirements on any city, county, or other local municipalities. 2. This rule will not produce a Federal mandate of $100 million or greater in any year ( *i.e.,* it is not a “significant regulatory action” under the Unfunded Mandates Reform Act). This NEP designation for the falcon will not impose any additional management or protection requirements on the States or other entities. Takings (E.O. 12630) In accordance with Executive Order 12630, the rule does not have significant takings implications. We do not expect this rule to have a potential takings implication under Executive Order 12630 because it would exempt individuals or corporations from prosecution for take that is accidental and incidental to an otherwise lawful activity. Because of the substantial regulatory relief provided by the NEP designation, we do not believe the reintroduction of falcons would conflict with existing or proposed human activities or hinder public use of lands within the NEP area. Neither of the States within the NEP area will be required to specifically manage or reintroduce falcons. A takings implication assessment is not required because this rule

(1)will not effectively compel a property owner to suffer a physical invasion of property and

(2)will not deny all economically beneficial or productive uses of the land or aquatic resources. This rule will substantially advance a legitimate government interest (conservation and recovery of a federally listed bird) and will not present a barrier to all reasonable and expected beneficial use of private property. Federalism (E.O. 13132) In accordance with Executive Order 13132, we have considered whether this rule has significant Federalism effects and have determined that a Federalism assessment is not required. This rule will not have substantial direct effects on the States, in the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. In keeping with Department of the Interior policy, we requested information from and coordinated development of this rule with the affected resource agencies in New Mexico and Arizona. Achieving the recovery goal for this species will contribute to its eventual delisting and its return to primary State management. No intrusion on State policy or administration is expected; roles or responsibilities of Federal or State governments will not change; and fiscal capacity will not be substantially directly affected. The special rule operates to maintain the existing relationship between the States and the Federal Government and is being undertaken in coordination with the States. Therefore, this rule does not have significant Federalism effects or implications to warrant the preparation of a Federalism Assessment pursuant to the provisions of Executive Order 13132. Civil Justice Reform (E.O. 12988) In accordance with Executive Order 12988 (February 7, 1996; 61 FR 4729), the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order. Government-to-Government Relationship With Tribes In accordance with Secretarial Order 3206, American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act (June 5, 1997); the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951); Executive Order 13175; and the Department of the Interior's requirement at 512 DM 2, we have notified the Native American Tribes within the NEP area about the proposed rule and this final rule. They have been advised through verbal and written contact, including informational mailings from the Service. Information was also presented at the Native American Fish and Wildlife Society meeting in New Mexico in 2003 (Murphy 2003). Furthermore, the potential reintroduction area for falcons in New Mexico does not overlap with any Tribal lands, and we do not expect falcons to move out of their preferred habitats. If future activities resulting from this rule may affect Tribal resources, the Service will communicate and consult on a Government-to-Government basis with any affected Native American Tribes in order to find a mutually agreeable solution. Paperwork Reduction Act Office of Management and Budget

(OMB)regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ) require that Federal agencies obtain approval from OMB before collecting information from the public. A Federal 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. OMB approval is required if information will be collected from 10 or more persons (5 CFR 1320.3). “Ten or more persons” refers to the persons to whom a collection of information is addressed by the agency within any 12-month period, and to any independent entities to which the initial addressee may reasonably be expected to transmit the collection of information during that period, including independent State, territorial, Tribal, or local entities and separately incorporated subsidiaries or affiliates. For the purposes of this definition, “persons” does not include employees of the respondent acting within the scope of their employment, contractors engaged by a respondent for the purpose of complying with the collection of information, or current employees of the Federal government when acting within the scope of their employment, but it does include former Federal employees. The Office of Management and Budget has approved our collection of information associated with reporting the taking of experimental populations (50 CFR 17.84(p)(6)) and assigned control number 1018-0095. The monitoring plan for reestablishment of the falcon contains a requirement for information collection; however, it does not affect 10 or more persons, as defined above. Therefore, OMB approval and a control number are not needed for the data collection forms appended to the monitoring plan. In the future, if it becomes necessary to collect this information from 10 or more respondents per year, we will first obtain approval from OMB. National Environmental Policy Act We have prepared an environmental assessment and Finding of No Significant Impact, as defined under the authority of the National Environmental Policy Act of 1969. These documents are available from the New Mexico Ecological Services Field Office (see ADDRESSES section) or from our Web site at *http://www.fws.gov/ifw2es/NewMexico/.* Energy Supply, Distribution or Use (E.O. 13211) On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not expected to significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required. References Cited A complete list of all references cited in this rule is available upon request from the New Mexico Ecological Services Field Office (see ADDRESSES section) and from our Web site at *http://www.fws.gov/ifw2es/NewMexico/.* Authors The primary authors of this notice are the New Mexico Ecological Services Field Office staff (see ADDRESSES section). List of Subjects in 50 CFR Part 17 Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation. Final Regulation Promulgation Accordingly, we amend part 17, subchapter B of Chapter I, title 50 of the Code of Federal Regulations, as set forth below: PART 17—[AMENDED] 1. The authority citation for part 17 continues to read as follows: Authority: 16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99-625, 100 Stat. 3500; unless otherwise noted. 2. Amend § 17.11(h) by revising the existing entry for “Falcon, northern aplomado” under “BIRDS” to read as follows: § 17.11 Endangered and threatened wildlife.

(h)* * * Species Common name Scientific name Historic range Vertebrate population where endangered or threatened Status When listed Critical habitat Special rules * * * * * * * **Birds** * * * * * * * Falcon, northern aplomado *Falco femoralis septentrionalis* U.S.A. (AZ, NM, TX), Mexico, Guatemala Entire, except where listed as an experimental population E 216 NA NA Falcon, northern aplomado *Falco femoralis septentrionalis* U.S.A. (AZ, NM, TX), Mexico, Guatemala U.S.A. (AZ, NM) XN 758 NA 17.84(p) * * * * * * * 3. Amend § 17.84 by adding paragraph

(p)to read as follows: § 17.84 Special rules—vertebrates.

(p)Northern aplomado falcon ( *Falco femoralis septentrionalis* ).

(1)The northern aplomado falcon ( *Falco femoralis septentrionalis* ) (falcon) population identified in paragraph (p)(9)(i) of this section is a nonessential experimental population (NEP).

(2)No person may take this species, except as provided in paragraphs (p)(3) through

(5)and (p)(10) of this section.

(3)Any person with a valid permit issued by the U.S. Fish and Wildlife Service (Service) under § 17.32 may take falcons for educational purposes, scientific purposes, the enhancement of propagation or survival of the species, zoological exhibition, and other conservation purposes consistent with the Endangered Species Act (Act);

(4)A falcon may be taken within the NEP area, provided that such take is not willful, knowing, or due to negligence, or is incidental to and not the purpose of the carrying out of an otherwise lawful activity; and that such taking is reported within 24 hours, as provided under paragraph (p)(6) of this section.

(5)Any employee of the Service, New Mexico Department of Game and Fish, or Arizona Game and Fish Department, who is designated for such purpose, or any person with a valid permit issued by the Service under 50 CFR 17.32, may, when acting in the course of official duties, take a falcon if such action is necessary to:

(i)Aid a sick, injured, or orphaned specimen;

(ii)Dispose of a dead specimen, or salvage a dead specimen that may be useful for scientific study;

(iii)Move a bird within the NEP area for genetic purposes or to improve the health of the population;

(iv)Relocate falcons that have moved outside the NEP area, by returning the falcon to the NEP area or moving it to a captive breeding facility. All captures and relocations from outside the NEP area will be conducted with the permission of the landowner(s) or appropriate land management agencies; or

(v)Collect nesting data or band individuals.

(6)Any taking pursuant to paragraphs (p)(3) through

(5)of this section must be reported within 24 hours by contacting the U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office, 2105 Osuna NE, Albuquerque, NM 87113;

(505)346-2525. Upon contact, a determination will be made as to the disposition of any live or dead specimens.

(7)No person shall possess, sell, deliver, carry, transport, ship, import, or export by any means whatsoever, any such species taken in violation of these regulations.

(8)It is unlawful for any person to attempt to commit, solicit another to commit, or cause to be committed, any offense defined in paragraphs (p)(2) and (p)(7) of this section. (9)(i) The boundaries of the designated NEP area are based on county borders and include the entire States of New Mexico and Arizona. The reintroduction area is within the historical range of the species in New Mexico.

(ii)All falcons found in the wild within the boundaries of the NEP area after the first releases will be considered members of the NEP. A falcon occurring outside of the NEP area is considered endangered under the Act unless it is marked or otherwise known to be a member of the NEP.

(iii)The Service has designated the NEP area to accommodate the potential future movements of a wild population of falcons. All released birds and their progeny are expected to remain in the NEP area due to the geographic extent of the designation.

(10)The NEP will be monitored closely for the duration of the reintroduction program. Any bird that is determined to be sick, injured, or otherwise in need of special care will be recaptured to the extent possible by Service and/or State or permitted Tribal wildlife personnel and given appropriate care. Such birds will be released back to the wild as soon as possible, unless physical or behavioral problems make it necessary to return them to a captive-breeding facility or they are euthanized if treatment would be unlikely to be effective.

(11)The Service plans to evaluate the status of the NEP every 5 years to determine future management status and needs, with the first evaluation expected to be not more than 5 years after the first release of birds into the NEP area. All reviews will take into account the reproductive success and movement patterns of individuals released, food habits, and overall health of the population. This evaluation will include a progress report. Dated: July 7, 2006. Matt Hogan, Acting Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. 06-6486 Filed 7-21-06; 3:06 pm]

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