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Code · REGISTER · 2007-05-09 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

39,801 words·~181 min read·/register/2007/05/09/07-2281

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4910-13-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect a change of sponsor's name from American Pharmaceutical Partners, Inc., to Abraxis Pharmaceuticals Products and to change the sponsor's mailing address. DATES: This rule is effective May 9, 2007. FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: *david.newkirk@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: American Pharmaceuticals Partners, Inc., 2045 North Cornell Ave., Melrose Park, IL 60160, has informed FDA of a change of name and mailing address to Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, Il 60018. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. Section 510.600 is amended in the table in paragraph (c)(1) by removing the entry for “American Pharmaceuticals Partners, Inc.” and alphabetically adding a new entry for “Abraxis Pharmaceutical Products”; and in the table in paragraph (c)(2) by revising the entry for “063323” to read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(c)* * *
(1)* * * Firm name and address Drug labeler code * * * * * Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 063323 * * * * *
(2)* * * Drug labeler code Firm name and address * * * * * 063323 Abraxis Pharmaceutical Products, a Div. of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018 * * * * * Dated: May 1, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-8870 Filed 5-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 529 Certain Other Dosage Form New Animal Drugs; Oxytetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of oxytetracycline hydrochloride soluble powder for skeletal marking of finfish fry and fingerlings by immersion. DATES: This rule is effective May 9, 2007. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-460 that provides for use of TETROXY Aquatic (oxytetracycline hydrochloride) Soluble Powder for skeletal marking of finfish fry and fingerlings by immersion. The application is approved as of April 20, 2007, and the regulations are amended in 21 CFR 529.1660 to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 529 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 529 is amended as follows: PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 2. In § 529.1660, revise paragraph (b)(1) to read as follows: § 529.1660 Oxytetracycline.
(b)* * *
(1)Nos. 046573 and 061623 for use of product in paragraph (a)(1) of this section. Dated: May 1, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-8869 Filed 5-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. 2007N-0136] Medical Devices; Immunology and Microbiology Devices; Classification of Gene Expression Profiling Test System for Breast Cancer Prognosis AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is classifying gene expression profiling test systems for breast cancer prognosis into class II (special controls). The special control that will apply to the device is the guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of the guidance document that will serve as the special control for this device. DATES: This final rule is effective June 8, 2007. The classification was effective February 6, 2007. FOR FURTHER INFORMATION CONTACT: Reena Philip, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-1286. SUPPLEMENTARY INFORMATION: I. What Is the Background of This Rulemaking? In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976 (the amendments), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations. Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) of the act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1) of the act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the act. FDA shall, within 60 days of receiving such a request, classify the device by written order. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the **Federal Register** announcing such classification (section 513(f)(2) of the act). In accordance with section 513(f)(1) of the act, FDA issued an order on January 19, 2007, classifying the Agendia BV, MAMMAPRINT as class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. Agendia BV submitted a petition dated January 22, 2007, requesting classification of the MAMMAPRINT under section 513(f)(2) of the act. FDA filed the petition on January 30, 2007. The manufacturer recommended that the device be classified into class II. In accordance with section 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the Agendia BV, MAMMAPRINT can be classified in class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of safety and effectiveness of the device. The device is assigned the generic name “gene expression profiling test system for breast cancer prognosis.” It is identified as a device that measures the ribonucleic acid
(RNA)expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer. A gene expression profiling test system for breast cancer prognosis is intended to provide prognostic information to aid in clinical evaluation of breast cancer patients. Failure of this device to perform as indicated may lead to erroneous test results. False positive results will misclassify the patient into a higher risk group and false negative results will misclassify the patient into a lower risk group. Misclassification of cancer recurrence risk may lead to incorrect prognosis with attendant psychological distress, inaccurate counseling, and suboptimal patient care. FDA believes the class II special controls guidance document will aid in mitigating potential risks by providing recommendations on labeling and validation of performance characteristics. The guidance document also provides information on how to meet premarket (510(k)) submission requirements for the device. FDA believes that following the class II special controls guidance document generally addresses the risks to health identified in the previous paragraph. Therefore, on February 6, 2007, FDA issued an order to the petitioner classifying the device into class II. FDA is codifying this classification by adding § 866.6040. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a gene expression profiling test system for breast cancer prognosis will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance, or in some other way provides equivalent assurance of safety and effectiveness. Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, however, FDA has determined that premarket review of the system's key performance characteristics, test methodology, labeling, and other requirements as outlined in § 807.87, will provide reasonable assurance that acceptable levels of performance for both safety and effectiveness will be addressed before marketing clearance. Thus, persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the gene expression profiling test system for breast cancer prognosis they intend to market. II. What Is the Environmental Impact of This Rule? The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. What Is the Economic Impact of This Rule? FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive Order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because classification of these devices into class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the agency certifies that the final rule will not have a significant impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. IV. Does This Final Rule Have Federalism Implications? FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required. V. How Does This Rule Comply With the Paperwork Reduction Act of 1995? This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VI. What References Are on Display? The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Petition from Agendia BV, dated January 22, 2007. List of Subjects in 21 CFR Part 866 Biologics, Laboratories, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The authority citation for 21 CFR part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 2. Section 866.6040 is added to subpart G to read as follows: § 866.6040 Gene expression profiling test system for breast cancer prognosis.
(a)*Identification* . A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid
(RNA)expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.
(b)*Classification* . Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document. Dated: May 1, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-8871 Filed 5-8-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 [OH-251-FOR] Ohio Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We are approving an amendment to the Ohio regulatory program (the “Ohio program”) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). This amendment is intended to remove certain Conflict of Interest provisions from the approved Ohio program that were previously approved by OSM but have not been promulgated by Ohio through their rulemaking process. EFFECTIVE DATE: May 9, 2007. FOR FURTHER INFORMATION CONTACT: Mr. George Rieger, Chief, Pittsburgh Field Division, Telephone:
(717)782-4036. E-mail: *grieger@osmre.gov* . SUPPLEMENTARY INFORMATION: I. Background on the Ohio Program II. Submission of the Amendment III. OSM's Findings IV. Summary and Disposition of Comments V. OSM's Decision VI. Procedural Determinations I. Background on the Ohio Program Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of the Act * * * and rules and regulations consistent with regulations issued by the Secretary pursuant to the Act.” See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Ohio program on August 16, 1982. You can find background information on the Ohio program, including the Secretary's findings, the disposition of comments, and conditions of approval of the Ohio program in the August 16, 1982, **Federal Register** (47 FR 34687). You can also find later actions concerning Ohio's program and program amendments at 30 CFR 935.11, 935.15, and 935.16. II. Submission of the Amendment By letter dated August 30, 2006, Ohio sent us a proposed amendment to its program (Administrative Record Number OH-2187-00) under SMCRA (30 U.S.C. 1201 *et seq.* ). In its letter, Ohio stated that it has reviewed amendments previously proposed by Ohio in Program Amendment #69. Ohio stated that those amendments of program amendment #69 related to Conflict of Interest have not been promulgated by Ohio and are deemed to be no longer necessary. Therefore, Ohio stated, it would like to withdraw the Conflict of Interest amendments from consideration by OSM. OSM approved the Conflict of Interest amendments that Ohio proposed in program amendment #69 (including the subsequent revisions) in the **Federal Register** on July 17, 1995 (60 FR 36352). Because we had already published our approval of the Conflict of Interest provisions that Ohio has requested be withdrawn from consideration, we were unable to merely withdraw those provisions. Rather, we sought public comment on whether the removal of the Conflict of Interest provisions that we approved in 1995 would render the approved Ohio program less effective than SMCRA and the Federal regulations. *Background Information:* Ohio program amendment #69 was originally submitted by Ohio by letter dated September 22, 1994 (Administrative Record Number OH-2059). Revisions to amendment #69 were subsequently submitted by letters dated March 8, 1995, and May 3, 1995 (Administrative Record Numbers OH-2099 and OH-2115, respectively). We announced receipt of those proposed amendments, and the two revisions, in the October 21, 1994; March 17, 1995; and May 12, 1995; **Federal Register** (59 FR 53122, 60 FR 14401, and 60 FR 25660, respectively). We approved the amendments in the July 17, 1995, **Federal Register** notice. We announced receipt of Ohio's request that we remove the Conflict of Interest provisions from the approved Ohio program in the October 19, 2006, **Federal Register** ( 71 FR 61695). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the proposed amendment (Administrative Record Number OH-2187-01). We did not hold a hearing or meeting because no one requested one. The public comment period ended on November 20, 2006. We received no comments. III. OSM's Findings Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment. Any revisions that we do not specifically discuss below concern nonsubstantive minor wording, editorial, or renumbering of sections changes, and are approved herein without discussion. Restrictions on Financial Interest of Employees. Ohio Administrative Code
(OAC)Section 1501:13-1-03 1. OAC 1501: 13-1-03(D)(2) Definition of “Employee” In its September 22, 1994, amendment, Ohio proposed to revise the definition of “Employee” at paragraph (D)(2) to provide that members of the Ohio Board (currently “Council”) on Unreclaimed Strip Mined Lands are included under the definition of “employee.” Ohio also proposed to revise this paragraph to provide that, for the purposes of OAC Section 1501:13-1-03, hearing officers for the Ohio Reclamation Board of Review (currently the Reclamation Commission) shall also be included within the definition of “employee.” Ohio also proposed to revise the appeal procedures at paragraphs (L)(1) and
(2)to delete separate references to the Reclamation Commission's hearing officers because those hearing officers are to be included under the definition of “employee” in this rule. We approved these revisions in our July 17, 1995, notice. In its August 30, 2006, letter to OSM, Ohio requested that the provisions that OSM approved on July 17, 1995, be withdrawn. Under this request, therefore, neither members of the Council nor hearing officers for the Reclamation Commission would be specifically identified as “employees” under the definition of “employee” at paragraph (D)(2). To approve these deletions from the Ohio provisions that were approved by OSM, we must determine whether the deletions render the Ohio program less effective than the Federal definition of “employee” at 30 CFR 705.5. The Federal definition of “employee” at 30 CFR 705.5 provides as follows: Employee. Means
(a)any person employed by the State Regulatory Authority who performs any function or duty under the Act, and
(b)advisory board or commission members and consultants who perform any function or duty under the Act, if they perform decisionmaking functions for the State Regulatory Authority under the authority of State law or regulations. However, members of advisory boards or commissions established in accordance with State law or regulations to represent multiple interests are not considered to be employees. State officials may through State law or regulations expand this definition to meet their program needs. The Ohio Revised Code
(ORC)at section 1513.29 establishes the Council. Under ORC 1513.29, the Council's duties involve gathering information on unreclaimed strip mined lands, studying, and making recommendations concerning eroded land within the State, including land affected by strip mining for which no cash is held in the strip mining reclamation fund. In addition, an Ohio Attorney General's Opinion from 1978 states that the Council “has the authority as a matter of law to fund reclamation projects on private lands pursuant to Chapter 1513 of the Revised Code * * *.” (Ohio Op. Atty Gen No. 78-016) That is, members of the Council perform a function or duty under Chapter 1513 of the Ohio Revised Code, and fall within the definition of “employee” in OAC 1501: 13-1-03. We find that the existing Ohio definition of “employee” which does not specifically identify members of the Council as employees does not render the Ohio program less effective than the Federal definition of “employee” at 30 CFR 705.5 and can be approved. Next, we will consider whether hearing officers for the Reclamation Commission are considered employees under the Federal regulations. The ORC at 1513.05 establishes the Reclamation Commission. That provision also provides that “The commission shall appoint one or more hearing officers who shall be attorneys at law admitted to practice in this state to conduct hearings under this chapter.” Therefore, it is clear that hearing officers for the Reclamation Commission are not members of the Reclamation Commission, but are appointed by the Reclamation Commission to conduct hearings. It is our understanding that the hearing officer for the Reclamation Commission is an employee of the Ohio Department of Natural Resources and is considered by that department to be an “employee” under the Ohio definition of “employee” at OAC 1501: 13-1-03 and is required to file the appropriate conflict of interest forms under OAC 1501: 13-1-03(I). Therefore, we find that the existing Ohio definition of “employee” which does not specifically identify hearing officers for the Reclamation Commission as employees does not render the Ohio program less effective than the Federal definition of “employee” at 30 CFR 705.5 and can be approved. Our approval is based upon our understanding noted above. 2. OAC 1501: 13-1-03(I)(1) Use of Financial Interest Statement Form by Members of the Ohio Reclamation Commission In its September 22, 1994, amendment, Ohio proposed to revise paragraph (I)(1) to add that members of the Ohio Reclamation Board of Review (currently Reclamation Commission) shall report all required information concerning employment and financial interests on Form OSM-23. We approved the provisions on July 17, 1995. On August 30, 2006, Ohio requested that its amendments to paragraph (I)(1) that we approved in 1995 be withdrawn. In effect, the phrase “and members of the Reclamation Board of Review” (currently the Reclamation Commission) will be deleted from provision concerning what to file at OAC 1501: 13-1-03(I)(1). The Federal regulations at 30 CFR 705.11(a) provide that employees and members of advisory boards and commissions established in accordance with State laws or regulations to represent multiple interests, who perform a function or duty under SMCRA, must file a statement of employment and financial interests. The Ohio Reclamation Commission is such a multi-interest advisory board and, therefore, must file a statement of employment and financial interests. The current Ohio provision at OAC 1501: 13-1-03(F)(1), concerning who shall file, provides that members of the Reclamation Commission are required to file a statement of employment and financial interests. Therefore, despite the fact that OAC 1501: 13-1-03(I)(1) concerning what to file does not specifically mention members of the Reclamation Commission, the Commission members are required to file by Ohio's regulations. Therefore, we find that the existing Ohio provision at OAC 1501: 13-1-03(I)(1), despite the fact that it does not specifically mention members of the Reclamation Commission definition, does not render the Ohio program less effective than the Federal regulations at 30 CFR 705.11(a) and can be approved. We note that OAC 1501: 13-1-03(I)(1) provides that the report shall be on “OSM Form 705-1” as provided by OSM. This form number is not correct. The form that OSM will provide for reporting financial interests is OSM “Form 23.” 3. OAC 1501: 13-1-03(J)(1) Acceptance of Gifts and Gratuities by Members of the Ohio Reclamation Commission In its September 22, 1994, amendment, Ohio proposed to revise paragraph (J)(1) to prohibit, with certain exceptions, the solicitation or acceptance of gifts and gratuities by members of the Ohio Reclamation Board of Review (currently Reclamation Commission) from coal companies which are conducting or seeking to conduct regulated activities or which have an interest that may be substantially affected by the performance of the Reclamation Commission members' official duties. We approved the provisions on July 17, 1995. On August 30, 2006, Ohio requested that its amendments to paragraph (J)(1) that we approved be withdrawn. In effect, the phrase “and members of the Reclamation Board of Review” will be deleted from the approved Ohio program at OAC 1501: 13-1-03(J)(1) concerning gifts and gratuities. Despite the fact that the Ohio provision at OAC 1501: 13-1-03(J)(1) does not prohibit members of the Reclamation Commission from soliciting or accepting gifts or any other thing of monetary value, the Ohio program is not rendered less effective than the Federal regulations at 30 CFR 705.18 concerning gifts and gratuities. Without the language that we approved on July 17, 1995, the State rule at OAC 1501: 13-1-03(J)(1) is substantively identical to the counterpart Federal regulations at 30 CFR 705.18(a) concerning the prohibitions against soliciting or receiving gifts and gratuities. That is, the Federal regulations do not require that members of multi-interest boards such as the Reclamation Commission must comply with the prohibitions against soliciting or receiving gifts and gratuities at 30 CFR 705.18. The Federal regulations at 30 CFR 705.4(d) do provide, however, that members of multi-interest boards must recuse themselves from proceedings which may affect their direct or indirect financial interests. The counterpart State provision concerning recusal is OAC 1501: 13-1-03(C). Additionally, the Federal regulations at 30 CFR 705.11(a) provide that members of multi-interest boards must file a statement of employment and financial interests. The counterpart State provision concerning the requirement for members of multi-interest boards to file a statement of employment and financial interests is OAC 1501: 13-1-03(F)(1). Therefore, we find that the removal of the words “and members of the Reclamation Board of Review” from OAC 1501: 13-1-03(J)(1) does not render the Ohio provision less effective than the counterpart Federal regulation at 30 CFR 705.18(a) and can be approved. 4. OAC 1501: 13-1-03(L)(1) Appeal of Remedial Actions In its September 22, 1994, amendment, Ohio proposed to revise paragraph (L)(1) to add that nothing in OAC Section 1501:13-1-03 modifies any right of appeal that any employee may have under State law of a decision by the Chief of the Division of Natural Resources, on an employee's appeal of remedial action for prohibited financial interests. The State also deleted the words “and such board's hearing officers” from the provision. We approved the provisions on July 17, 1995. On August 30, 2006, Ohio requested that the amendment to paragraph (L)(1) that we approved be withdrawn. The existing State provision at OAC 1501: 13-1-03(L)(1), without the language that the State has requested be removed from the approved program, provides as follows:
(1)Employees other than the chief of the Division of Mineral Resources Management and members of the reclamation commission and such commission's hearing officers may file their appeal in writing with the chief, who will conduct an informal hearing on the merits. The counterpart Federal regulations at 30 CFR 705.21(a) concerning appeals procedures provide as follows:
(a)Employees other than the Head of the State Regulatory Authority, may file their appeal, in writing, through established procedures within their particular State. The Federal regulation at 30 CFR 705.21(a) that is quoted above provides that conflict of interest appeal procedures for employees within a State should be governed by established procedures within the State. That is, the Federal conflict of interest provisions provide that the State has the discretion to establish its own appeal procedures. Additionally, the Federal regulations at 30 CFR 705.21(a) do not contain a counterpart to the language that Ohio wishes to be deleted from the approved program, which provides that nothing in the rule modifies any right of appeal of the Chief's decision that any employee may have under State law. Therefore, the removal of that language does not render OAC 1501: 13-1-03(L)(1) less effective than the Federal regulations at 30 CFR 705.21(a). Therefore, we find that the existing State provision at OAC 1501: 13-1-03(L)(1) is not inconsistent with the Federal conflict of interest provisions at 30 CFR 705.21 and can be approved. 5. OAC 1501: 13-1-03(L)(2) Appeal of Remedial Actions In its September 22, 1994, amendment, Ohio proposed to revise paragraph (L)(2) by deleting language so that paragraph (L)(2) provides that only the Chief of the Division of Reclamation (currently the Division of Mineral Resources Management) may appeal a remedial action to the Director of OSM. We approved the proposed deletion of language on July 17, 1995. On August 30, 2006, Ohio requested that the proposed deletion at paragraph (L)(2) that we approved be withdrawn. As a result, the existing State provision at OAC 1501: 13-1-03(L)(2) provides as follows:
(2)The chief of the Division of Mineral Resources Management and members of the reclamation commission and such commission's hearing officers may file their appeal in writing, with the director of the office of surface mining reclamation and enforcement, who will refer it to the conflict of interest appeals board within the United States Department of the Interior. Under paragraph (L)(2), therefore, the Chief of the Division of Mineral Resources Management, members of the Reclamation Commission, and the Commission's hearing officers may file their appeals of orders for remedial action under paragraph
(K)with OSM. Under the Federal regulations, appeal procedures for employees are specified at 30 CFR 705.21(a), which provides that employees may file their appeals through established procedures within their respective States. Under the Federal regulations, appeal procedures for the head of the regulatory authority are specified at 30 CFR 705.21(b), which provides that the head of the State regulatory authority may file an appeal with OSM who will refer it to the Conflict of Interest Appeals Board within the Department of the Interior. Insofar as it applies to the Chief of the Division of Mineral Resources Management, who is the head of the Ohio Regulatory Authority, restored paragraph (L)(2) is substantively identical to, and therefore no less effective than, the Federal regulations at 30 CFR 705.21(b). With respect to Reclamation Commission hearing officers, who are “employees” under Ohio's approved program, restored paragraph (L)(2) is no less effective than 30 CFR 705.21(a), which allows States to establish appeal procedures for all employees except for the head of the regulatory authority. For hearing officers, the “established procedures” in Ohio will be those applicable to the United States Department of the Interior's Conflict of Interest Appeals Board. Finally, there are no specific Federal provisions concerning appeals of conflict of interest decisions by members of multiple interest boards, such as members of Ohio's Reclamation Commission. However, nothing in SMCRA or the Federal regulations prohibits Ohio from allowing these members to appeal these types of decisions. Therefore, restored paragraph (L)(2) is not inconsistent with SMCRA or the Federal regulations insofar as it applies to members of the Reclamation Commission. For all of these reasons, we are approving restored paragraph (L)(2). 6. OAC 1501: 13-1-03(L)(3) Appeal of Remedial Actions In its September 22, 1994, amendment, Ohio proposed to add new paragraph (L)(3) to provide that members of the Ohio Reclamation Board of Review (currently the Reclamation Commission) may request advisory opinions from the Director of OSM on issues pertaining to an apparent prohibited financial interest. The provision also stated that resolution of conflicts is governed by section 1513.05 and 1513.29 of the Ohio Revised Code. We approved the proposed new language on July 17, 1995. On August 30, 2006, Ohio requested that the proposed new language at paragraph (L)(3) that we approved be withdrawn. As noted above at Finding 5, the existing Ohio provision at OAC 1501: 13-1-03(L)(2) provides that members of the Reclamation Commission and such Commission's hearing officers may file an appeal in writing, with the Director of OSM. Therefore, the provision that we approved on July 17, 1995, at OAC 1501: 13-1-03(L)(3), which also provides that members of the Commission may request advisory opinions from OSM is not necessary. We find that the removal of paragraph (L)(3) from the approved Ohio program does not render the Ohio program less effective than the Federal regulations at 30 CFR 705.21 concerning appeal procedures and can be approved. We note that the language at paragraph (L)(3) also provided that resolution of conflicts is governed by section 1513.05 of the Ohio Revised Code. However, the removal of paragraph (L)(3) from the Ohio program does not negate the fact that the provisions at ORC 1513.05 and 1513.29 continue to apply to the Reclamation Commission. IV. Summary and Disposition of Comments Public Comments On October 19, 2006, we published a **Federal Register** notice and asked for public comments of the amendment (Administrative Record Number OH-OH-2187-01). No comments were received. Federal Agency Comments Under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Ohio program (Administrative Record Number OH-2187-02). No comments were received. Environmental Protection Agency
(EPA)Concurrence and Comments Under 30 CFR 732.17(h)(11) (ii), we are required to obtain written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq.) or the Clean Air Act (42 U.S.C. 7401 et seq.). None of the revisions that Ohio proposed to make in this amendment pertain to air or water quality standards. Therefore, we did not ask EPA to concur on the amendment. Under 30 CFR 732.17(h)(11)(i), we requested comments on the amendment from EPA (Administrative Record Number OH-2187-02). No EPA comments were received. V. OSM's Decision Based on the above findings, we are approving, the program amendment that Ohio sent to us on August 30, 2006. To implement this decision, we are amending the Federal regulations at 30 CFR part 935, which codify decisions concerning the Ohio program. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards. VI. Procedural Determinations Executive Order 12630—Takings This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations. Executive Order 12866—Regulatory Planning and Review This rule is exempted from review by the Office of Management and Budget
(OMB)under Executive Order 12866. Executive Order 12988—Civil Justice Reform The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that, to the extent allowable by law, this rule meets the applicable standards of subsections
(a)and
(b)of that section. However, these standards are not applicable to the actual language of State regulatory programs and program amendments since each such program is drafted and promulgated by a specific State, not by OSM. Under sections 503 and 505 of SMCRA (30 U.S.C. 1253 and 1255) and the Federal regulations at 30 CFR 730.11, 732.15, and 732.17(h)(10), decisions on proposed State regulatory programs and program amendments submitted by the States must be based solely on a determination of whether the submittal is consistent with SMCRA and its implementing Federal regulations and whether the other requirements of 30 CFR parts 730, 731, and 732 have been met. Executive Order 13132—Federalism This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 503(a)(1) of SMCRA requires that State laws regulating surface coal mining and reclamation operations be “in accordance with” the requirements of SMCRA. Section 503(a)(7) requires that State programs contain rules and regulations “consistent with” regulations issued by the Secretary pursuant to SMCRA. Executive Order 13175—Consultation and Coordination With Indian Tribal Governments In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects 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. The basis for this determination is that our decision is on a State regulatory program and does not involve a Federal program involving Indian lands. Executive Order 13211—Regulations That Significantly Affect the Supply, Distribution, or Use of Energy On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is
(1)considered significant under Executive Order 12866, and
(2)likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required. National Environmental Policy Act Section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that a decision on a proposed State regulatory program provision does not constitute a major Federal action within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)). A determination has been made that such decisions are categorically excluded from the NEPA process (516 DM 8.4.A). Paperwork Reduction Act This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 *et seq.* ). Regulatory Flexibility Act The Department of the Interior has determined that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). The State submittal that is the subject of this rule is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. Accordingly, this rule will ensure that existing requirements previously promulgated by OSM will be implemented by the State. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations. Small Business Regulatory Enforcement Fairness Act This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a)Does not have an annual effect on the economy of $100 million;
(b)Will not cause a major increase in costs or prices for consumers, individual industries, geographic regions, or Federal, State or local governmental agencies; and
(c)Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule. Unfunded Mandates This rule will not impose a cost of $100 million or more in any given year on any governmental entity or the private sector. List of Subjects in 30 CFR Part 935 Intergovernmental relations, Surface mining, Underground mining. Dated: March 15, 2007. H. Vann Weaver, Acting Regional Director, Appalachian Region. For the reasons set out in the preamble, 30 CFR part 935 is amended as set forth below: PART 935—OHIO 1. The authority citation for part 935 continues to read as follows: Authority: 30 U.S.C. 1201 *et seq.* 2. Section 935.15 is amended by adding a new entry to the table in chronological order by “Date of final publication” to read as follows: § 935.15 Approval of Ohio regulatory program amendments. Original amendment submission date Date of final publication Citation/description * * * * * * * August 30, 2006 May 9, 2007 OAC 1501:13-1-03(D)(2), (I)(1), (J)(1), (L)(1), (L)(2), and the deletion of (L)(3). [FR Doc. E7-8867 Filed 5-8-07; 8:45 am] BILLING CODE 4310-05-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [COTP San Francisco Bay 07-006] RIN 1625-AA00 Safety Zone; KFOG “Kaboom” Fireworks Display, San Francisco Bay, CA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone in the navigable waters of San Francisco Bay for the loading, transport, inactive period, and launching of fireworks used during the KFOG “KaBoom” Fireworks Display to be held on May 12, 2007. This safety zone is intended to prohibit vessels and people from entering into or remaining within the regulated areas in order to ensure the safety of participants and spectators. DATES: This rule is effective from 8 a.m. on May 10, 2007, to 9:30 p.m. on May 12, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket, are part of docket COTP San Francisco Bay 07-006 and are available for inspection or copying at Coast Guard Sector San Francisco, 1 Yerba Buena Island, San Francisco, California, 94130, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Ensign Sheral Richardson, U.S. Coast Guard Sector San Francisco, at
(415)556-2950 extension 136. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Logistical details surrounding the event were not finalized and presented to the Coast Guard in time to draft and publish an NPRM. As such, the event would occur before the rulemaking process was complete. Because of the dangers posed by the pyrotechnics used in this fireworks display, safety zones are necessary to provide for the safety of event participants, 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. For the same reasons listed in the previous paragraph, 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** . Any delay in the effective date of this rule would expose mariners to the dangers posed by the pyrotechnics used in this fireworks display. Background and Purpose The San Francisco Radio Station KFOG is sponsoring a brief fireworks display on May 12, 2007 in the waters of San Francisco Bay near Piers 30 and 32. The fireworks display is meant for entertainment purposes in support of KFOG's annual festival in San Francisco. This safety zone is being issued to establish a temporary regulated area in San Francisco Bay around the fireworks launch barge during the loading of the pyrotechnics, during the transit of the barge to the display location, inactive period, and during the fireworks display. This temporary regulated area around the launch barge is necessary to protect spectators, vessels, and other property from the hazards associated with the pyrotechnics on the fireworks barge. The Coast Guard has granted the event sponsor a marine event permit for the fireworks display. Discussion of Rule The Coast Guard is establishing a temporary safety zone on specified waters off of the San Francisco waterfront. During the loading of the fireworks barge, while the barge is being towed to the display location, and until the start of the fireworks display, the safety zone will apply to the navigable waters around and under the fireworks barge within a radius of 100 feet. Fifteen minutes prior to and during the twenty-two minute fireworks display, the area to which this safety zone applies to will increase in size to encompass the navigable waters around and under the fireworks barge within a radius of 1,000 feet. Loading of the pyrotechnics onto the fireworks barge is scheduled to commence at 8 a.m. on May 10, 2007, and will take place at Pier 50 in San Francisco. Towing of the barge from Pier 50 to the display location is scheduled to take place on May 12, 2007. During the fireworks display, scheduled to commence at 9 p.m. on May 12, 2007, the fireworks barge will be located approximately 1,000 feet off of Pier 30 in position 37°47.21′ N, 122°22.86′ W. The effect of the temporary safety zone will be to restrict general navigation in the vicinity of the fireworks barge while the fireworks are loaded at Pier 50, during the transit of the fireworks barge, and until the conclusion of the scheduled display. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the safety zone. This safety zone is needed to keep spectators and vessels a safe distance away from the fireworks barge to ensure the safety of participants, spectators, and transiting vessels. 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. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public broadcast notice to mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are pleasure craft engaged in recreational activities. 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 is not expected to have a significant economic impact on a substantial number of entities, some of which may be small entities. This rule may affect owners and operators of pleasure craft engaged in recreational activities and sightseeing. This rule will not have a significant economic impact on a substantial number of small entities for several reasons:
(i)Vessel traffic can pass safely around the area,
(ii)vessels engaged in recreational activities and sightseeing have ample space outside of the effected portion of San Francisco Bay to engage in these activities,
(iii)this rule will encompass only a small portion of the waterway for a limited period of time, and
(iv)the maritime public will be advised in advance of this safety zone via public notice to mariners. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions, options for compliance, or assistance in understanding this rule, please contact Ensign Sheral Richardson, U.S. Coast Guard Sector San Francisco, at
(415)556-2950 extension 136. 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 calls 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. 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 will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not affect 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 does not create an environmental risk to health or risk to safety that may 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 does 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 and Department of Homeland Security Management Directive 5100.1, which guide 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)(g), of the Instruction, from further environmental documentation. Paragraph (34)(g) is applicable because this rule establishes a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T11-180 to read as follows: § 165.T11-180 Safety Zone; KFOG “KaBoom” Fireworks Display, San Francisco Bay, CA.
(a)*Location.* This safety zone is established for the waters of San Francisco Bay surrounding a barge used as a firework launch platform during the KFOG “KaBoom” fireworks display. During the loading of the fireworks barge, during the transit of the fireworks barge to the display location, and until the start of the fireworks display, the regulated area encompasses the navigable waters around and under the fireworks barge within a radius of 100 feet. Fifteen minutes prior to and during the twenty-two minute fireworks display, the temporary regulated area increases in size to encompass the navigable waters around and under the fireworks launch barge within a radius of 1,000 feet. Loading of the pyrotechnics onto the fireworks barge is scheduled to commence at 8 a.m. on May 10, 2007, and will take place at Pier 50 in San Francisco. Towing of the barge from Pier 50 to the display location is scheduled to take place on May 12, 2007. During the fireworks display, scheduled to start at 9 p.m. on May 12, 2007, the barge will be located approximately 1,000 feet from San Francisco Pier 30 in position 37°47.21′ N, 122°22.86′ W.
(b)*Enforcement Period.* This section will be enforced from 8 a.m. May 10, 2007 to 9:30 p.m. on May 12, 2007. If the event concludes prior to the scheduled termination time, the Coast Guard will cease enforcement of this safety zone and will announce that fact via Broadcast Notice to Mariners.
(c)*Regulations.* In accordance with the general regulations in § 165.23 of this part, entry into, transit through, or anchoring within this safety zone by all vessels and persons is prohibited, unless specifically authorized by the Captain of the Port San Francisco, or his designated representative.
(d)*Enforcement.* All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port, or the designated on-scene patrol personnel. Patrol personnel can be comprised of commissioned, warrant, and petty officers of the Coast Guard onboard Coast Guard, Coast Guard Auxiliary, local, state, and federal law enforcement vessels. Upon being hailed by U.S. Coast Guard patrol personnel by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed. The U.S. Coast Guard may be assisted in the patrol and enforcement of this safety zone by local law enforcement as necessary. Dated: April 20, 2007. W.J. Uberti, Captain, U.S. Coast Guard, Captain of the Port, San Francisco. [FR Doc. E7-8815 Filed 5-8-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [CGD05-07-040] RIN 1625 AA00 Safety Zone; Fireworks Display, Pamlico River, Washington, NC AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary safety zone during the “Washington Summer Festival and the Washington 4th of July Fireworks” displays to be held on the waters of the Pamlico River, Washington, North Carolina. This action is necessary to provide for the safety of life on navigable waters during the event. This action will restrict vessel traffic in portions of the Pamlico River adjacent to Washington, North Carolina during the fireworks display. DATES: This rule is effective from 8:30 p.m. on June 8 until 10 p.m. on July 4, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket [CGD05-07-040] and are available for inspection or copying at Commander (dpi), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: CWO Christopher Humphrey, Coast Guard Sector North Carolina, Atlantic Beach, NC at
(252)247-4525. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM would be impracticable and contrary to public interest since immediate action is needed to minimize potential danger to the public during the event. The necessary information to determine whether the marine event poses a threat to persons and vessels was not provided with sufficient time to publish an NPRM. The danger posed by fireworks fall-out makes a safety zone necessary to provide for the safety of 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. The Coast Guard will issue broadcast notice to mariners to advise vessel operators of navigational restrictions. On scene Coast Guard and local law enforcement vessels will also provide actual notice to mariners. Under 5 U.S.C. 553(d)(3) and for the same reasons, 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, spectator craft and other vessels transiting the event area. Advance notifications will be made to users of the Pamlico River via marine information broadcasts, local notice to mariners, commercial radio stations and area newspapers. Background and Purpose On June 8 & 9 and July 4, 2007 the Washington/Beaufort County Chamber of Commerce and the City of Washington will sponsor the “Washington Summer Festival” and the “4th of July” fireworks displays over the waters of the Pamlico River. A fleet of spectator vessels is anticipated to gather nearby to view the display. Due to the need for vessel control during the event, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels. Discussion of Rule The Coast Guard is establishing a safety zone on specified waters of the Pamlico River adjacent to Washington, North Carolina. The regulated area includes a section of the Pamlico River from the Highway 17 Swing Bridge south approximately one half mile long and bounded in width by each shoreline. The rule would be enforced from 8:30 p.m. until 10 p.m. and would restrict general navigation in the regulated area during the fireworks display. The Coast Guard, at its discretion, when practical would allow the passage of vessels when the fireworks displays are not taking place. Except for participants and vessels authorized by the Coast Guard Patrol Commander, no person or vessel would be allowed to enter or remain in the regulated area during the enforcement period. These regulations are needed to control vessel traffic during the events to enhance the safety of participants, spectators and transiting vessels. 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. Although this regulation restricts vessel traffic from transiting Pamlico River during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts and area newspapers so mariners can adjust their plans accordingly. 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 will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit the Pamlico River during the scheduled events. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be enforced for only a short period, from 8:30 p.m. until 10 p.m. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. 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 the address listed under ADDRESSES . 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 calls 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. 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 will 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 does not create an environmental risk to health or risk to safety that may 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 does 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, and Department of Homeland Security Management Directive 5100.1 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)(g), of the Instruction, from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it establishes a safety zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T05-040 to read as follows: § 165.T05-040 Safety Zone; Pamlico River, Washington, North Carolina.
(a)*Regulated area.* The safety zone includes all waters of Pamlico River south of the intersection of the Highway 17 Swing Bridge south along the west river bank to latitude 35°32′19″ N, longitude 077°03′40″ W, thence across the river on a line 045 degrees due northeast across the river to the intersection of the east river bank at position 35°32′30″ N, longitude 077°03′25″ W, thence north along the shoreline to the Highway 17 Swing Bridge thence west to the point of origin. All coordinates reference Datum NAD 1983.
(b)*Definitions.* The following definitions apply to this section:
(1)*Coast Guard Patrol Commander* means a commissioned, warrant, or petty officer of the Coast Guard who has been designated by the Commander, Coast Guard Sector North Carolina.
(2)*Official Patrol* means any vessel assigned or approved by the Sector Commander, Coast Guard Sector North Carolina with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.
(c)*Regulations.* The general regulations governing safety zones, found in 33 CFR 165.23, apply to the safety zone described in paragraph
(a)of this section.
(1)Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.
(2)The operator of any vessel in the regulated area must:
(i)Stop the vessel immediately when directed to do so by any Official Patrol.
(ii)Proceed as directed by any official patrol.
(d)*Enforcement period.* This section will be enforced from 8:30 p.m. to 10 p.m. on June 8 & 9 and July 4, 2007. Dated: April 24, 2007. Gregory D. Case, Commander, U.S. Coast Guard, Captain of the Port, Atlantic Beach, North Carolina. [FR Doc. E7-8814 Filed 5-8-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA-HQ-OPP-2006-0913; FRL-8124-6] Bacillus thuringiensis Vip3Aa19 Protein in Cotton; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an extension of the temporary exemption from the requirement of a tolerance for residues of the *Bacillus thuringiensis* Vip3Aa19 protein in cotton when applied/used as a plant-incorporated protectant (PIP). Syngenta Seeds, 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 the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of the *Bacillus thuringiensis* Vip3Aa19 protein in cotton when applied/used as a PIP on cotton. The temporary tolerance exemption expires on May 1, 2008. DATES: This regulation is effective May 9, 2007. Objections and requests for hearings must be received on or before July 9, 2007, 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-2006-0913. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)605-0515; e-mail address: *reynolds.alan@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 174 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 FFDCA, as amended by 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-2006-0913 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 July 9, 2007. 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-2006-0913, 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of January 12, 2007 (72 FR 1513) (FRL-8105-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 3G6547) by Syngenta Seeds, Inc., P.O. Box 12257, Research Triangle Park, NC 27709. The petition requested that 40 CFR 174.452 be amended by establishing an extension of the temporary exemption from the requirement of a tolerance for residues of the *Bacillus thuringiensis* Vip3A protein when applied/used as a PIP on cotton. This notice included a summary of the petition prepared by the petitioner Syngenta Seeds, Inc. No public comments were received. 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 exemption 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. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing 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.” Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues ” and “other substances that have a common mechanism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of 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. Data have been submitted demonstrating a lack of mammalian toxicity at high levels of exposure to the pure (microbially expressed) Vip3Aa19 protein. These data demonstrate the safety of Vip3Aa19 at levels well above maximum possible exposure levels that are reasonably anticipated in the crops. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial *Bacillus thuringiensis* products from which this PIP was derived (see 40 CFR 158.740(b)(2)(i)). For microbial products, the need for Tier II and III toxicity testing and residue data to verify the observed effects and clarify the source of these effects is triggered only by significant acute effects in studies such as the mouse oral toxicity study. In previously submitted Vip3A studies and applications, the designation VIP3A or Vip3A was used to describe the Vip PIP protein and/or test material. In the final rule, it is necessary to distinguish the various Vip3A designations based on the Crickmore *Bacillus thuringiensis* Vip3A nomenclature (see *http://www.lifesci.sussex.ac.uk/Home/Neil_Crickmore/Bt/* ). The original Vip3A toxin as expressed in COT102 is now known as Vip3Aa19 toxin according to the Crickmore nomenclature designation. A temporary exemption from the requirement of a tolerance already has been established for the *Bacillus thuringiensis* Vip3A protein and the genetic material necessary for its production in cotton published in the **Federal Register** on April 26, 2006 (71 FR 24582) (FRL-7772-7); (40 CFR 174.452). This temporary exemption from the requirement of a tolerance will be modified to reflect the new Crickmore designation, Vip3Aa19. An acute oral toxicity study was submitted for the Vip3Aa19 protein. Male and female mice (16 of each) were dosed with 3,675 milligrams/kilograms bodyweight (mg/kg bwt) of Vip3Aa19 protein. All mice survived the study, gained weight, had no test material related clinical signs, and had no test material related findings at necropsy. This acute oral toxicity data supports the prediction that the Vip3Aa19 protein would be non-toxic to humans. When proteins are toxic, they are known to act via acute mechanisms and at very low-dose levels (Sjoblad, Roy D., et al. 1992). Therefore, since no effects were shown to be caused by the PIPs, even at relatively high-dose levels, the Vip3Aa19 protein is not considered toxic. Amino acid sequence comparisons showed no similarity between the Vip3Aa19 protein and known toxic proteins available in public protein data bases. According to the Codex Alimintarius Commission (Codex) guidelines, the assessment of potential toxicity also includes stability to heat (Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, 2003 1 ). A heat liability study demonstrated that Vip3Aa19 is inactivated against fall armyworm when heated to 55 °C for 30 minutes. 1 Alinorm 03/34: Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, Twenty-Fifth Session, Rome, Italy 30 June-5 July, 2003. Appendix III, Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA plants and Appendix IV, Annex on the assessment of possible allergenicity. Rome, Codex Alimentarius Commission, 2003. pp. 47-60. Since Vip3Aa19 is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for determining the allergenic potential of novel proteins. Therefore, EPA uses a weight of the evidence approach where the following factors are considered: Source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including *in vitro* digestibility in simulated gastric fluid (SGF), and glycosylation. This approach was described by the Codex guidelines for the conduct of food safety assessment of food derived from recombinant-DNA plants including the assessment of possible allergenicity in 2003 (Joint FAO/WHO Food Standard Programme, Codex Alimentarius Commission, 2003). Data have been submitted that demonstrate that the Vip3A from recombinant maize (LPPACHA-0199) and *E. coli* (VIP3A-0100) proteins are rapidly degraded by gastric fluid *in vitro* . (VIP3A-0100 refers to a microbially expressed Vip3A that has been shown to be the equivalent of the plant-expressed Vip3A protein.) In a solution of simulated gastric fluid (containing pepsin) and either 80 µL of LPPACHA-0199 or 320 µL of VIP3A-0100 test protein, both were shown to be susceptible to pepsin degradation. These data support the conclusion that Vip3A proteins expressed in transgenic plants will be readily digested as a conventional dietary protein under typical mammalian gastric conditions. Further data demonstrate that Vip3Aa19 is not glycoslylated and a comparison of amino acid sequences of known allergens uncovered no evidence of any homology with Vip3Aa19, even at the level of eight contiguous amino acid residues. These data demonstrated that the mean Vip3Aa19 concentration in cotton seed ranged from ca. 2.51 to 3.23 µg Vip3A/g dry weight. Vip3Aa19 was not detected in cotton fiber or nectar. Analysis of the refined oil and de-fatted meal by Enzyme-Linked Immunosorbent Assay (ELISA) detected Vip3Aa19 protein in COT102 meal, but not in oil. Therefore, based on the data provided for the specific Vip3Aa19 protein, one can conclude that the Vip3Aa19 protein is present in low levels in cotton seed and not detected in cotton fiber. Therefore, the potential for the Vip3Aa19 protein to be a food allergen is minimal. As noted in Unit III., toxic proteins typically act as acute toxins at low-dose levels. Therefore, since no effects were shown to be caused by this PIP, even at relatively high-dose levels, the Vip3Aa19 protein is not considered toxic. IV. Aggregate Exposures In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. These considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the PIP chemical residue, and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the PIP is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid homology assessment revealed no similarities to known aeroallergens, indicating that Vip3Aa19 has a low potential to be an inhalation allergen. It has been demonstrated that there is no evidence of occupationally related respiratory symptoms, based on a health survey on migrant workers after exposure to *Bacillus thuringiensis* pesticides (Berstein, et al. 1999), which provides further evidence of the negligible respiratory risks of *Bacillus thuringiensis* PIPs. Exposure via residential or lawn use to infants and children is also not expected because the use sites for the Vip3Aa19 protein are all the agricultural for control of insects. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, theoretically, drinking water. However, oral toxicity testing done in rats at a dose in excess of 3 gram(g)/kg showed no adverse effects. Furthermore, the expected dietary exposure from cotton is several orders of magnitude lower than the amounts of Vip3Aa19 protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the Vip3Aa19 proteins. V. Cumulative Effects Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations include the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity, the Agency concludes that there are no cumulative effects arising from Vip3Aa19 protein residues in cotton. VI. Determination of Safety for U.S. Population, Infants and Children A. Toxicity and Allergenicity Conclusions The data submitted and cited regarding potential health effects for the Vip3Aa19 protein include the characterization of the expressed Vip3Aa19 protein in cotton, as well as the acute oral toxicity, heat stability, and *in vitro* digestibility of the proteins. The results of these studies were determined applicable to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were considered. Adequate information was submitted to show that the Vip3A protein test material derived from microbial cultures (designated VIP3A-0100) was biochemically and functionally similar to the Vip3Aa19 protein expressed in cotton. Microbially produced protein was chosen in order to obtain sufficient material for testing. The acute oral toxicity data submitted supports the prediction that the Vip3Aa19 protein would be non-toxic to humans. As mentioned Unit III., when proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Sjoblad, Roy D., et al. 1992). Since no effects were shown to be caused by Vip3Aa19 protein, even at relatively high dose levels (3,675 mg Vip3Aa19/kg bwt), the Vip3Aa19 protein is not considered toxic. This is similar to the Agency position regarding toxicity and the requirement of residue data for the microbial *Bacillus thuringiensis* products from which this PIP was derived. (See 40 CFR 158.740(b)(2)(i)). Moreover, Vip3Aa19 showed no sequence similarity to any known toxin. Protein residue chemistry data for Vip3Aa19 were not required for a human health effects assessment of the subject PIP ingredients because of the lack of mammalian toxicity. Expression data demonstrated that mean Vip3Aa19 concentrations in cotton seed ranged from approximately 2.51 to 3.23 µg Vip3Aa19/g dry weight. Vip3Aa19 was not detected in cotton fiber or nectar. Analysis of the refined oil and de-fatted meal by ELISA detected Vip3Aa19 protein in COT102 meal, but not in oil. Therefore, Vip3Aa19 is present in low levels in cotton seed and not detect in cotton fiber. Since Vip3Aa19 is a protein, its potential allergenicity is also considered as part of the toxicity assessment. Information considered as part of the allergenicity assessment included data demonstrating that the Vip3Aa19 protein came from a *Bacillus thuringiensis* which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that the Vip3Aa19 protein will not be an allergen. Neither available information concerning the dietary consumption patterns of consumers (and major identifiable subgroups of consumers including infants and children), nor safety factors that are generally recognized as appropriate for the use of animal experimentation data were evaluated. The lack of mammalian toxicity at high levels of exposure to the Vip3Aa19 protein, as well as the minimal potential to be a food allergen, demonstrate the safety of Vip3Aa19 at levels well above possible maximum exposure levels anticipated in the crop. The genetic material necessary for the production of the PIP active ingredients are the nucleic acids (DNA, RNA) which comprise genetic material encoding these proteins and their regulatory regions. The genetic material (DNA, RNA) necessary for the production of Vip3Aa19 protein already are exempted from the requirement of a tolerance under a blanket exemption for all nucleic acids (40 CFR 174.475). B. Infants and Children Risk Conclusions Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) also 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 determines that a different margin of safety will be safe for infants and children. In this instance, based on all the available information, the Agency concludes that there is a finding of no toxicity for the Vip3Aa19 protein and the genetic material necessary for its production in cotton. Because there are no threshold effects of concern, the Agency has determined that the additional tenfold margin of safety is not necessary to protect infants and children. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. C. Overall Safety Conclusion There is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Vip3Aa19 protein and the genetic material necessary for its production in cotton, when it is applied/used in accordance with good agricultural practices. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, as previously discussed, no toxicity to mammals has been observed, nor has there been any indication of allergenicity potential for this PIP. VII. Other Considerations A. Endocrine Disruptors The pesticidal active ingredient is a protein, derived from sources that are not known to exert an influence on the endocrine system. Therefore, the Agency is not requiring information on the endocrine effects of the PIP at this time. B. Analytical Method(s) A method for extraction and ELISA analysis of the Vip3Aa19 protein in cotton has been submitted and is under review by the Agency. For the temporary tolerance exemption, the ELISA method described with the expression data is sufficient. C. Codex Maximum Residue Level No Codex maximum residue levels exist for the PIP *Bacillus thuringiensis* Vip3Aa19 protein and the genetic material necessary for its production in cotton. VIII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of 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, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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* ., 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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, this rule does not 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). 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). IX. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 26, 2007. W. Michael McDavit, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: [PART 174—AMENDED] 1. The authority citation for part 174 continues to read as follows: Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371. 2. Section 174.452 is revised to read as follows: § 174.452 Bacillus thuringiensis Vip3Aa19 protein in cotton; temporary exemption from the requirement of a tolerance. Residues of *Bacillus thuringiensis* Vip3Aa19 protein in cotton are temporarily exempt from the requirement of a tolerance when used as a plant-incorporated protectant
(PIP)in the food and feed commodities of cotton; vegetative-insecticidal protein in cotton seed, cotton oil, cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin byproducts. This temporary exemption from the requirement of tolerance will permit the use of the food commodities in this section when treated in accordance with the provisions of the experimental use permit
(EUP)67979-EUP-7, which is being issued in accordance with the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the requirement of a tolerance expires and is revoked May 1, 2008. However, if the EUP is revoked, or if any experience with or scientific data on this pesticide indicate that the temporary tolerance exemption is not safe, this temporary exemption from the requirement of a tolerance may be revoked at any time. [FR Doc. E7-8951 Filed 5-8-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0965; FRL-8124-2] Flufenacet; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes pesticide tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA) for combined residues of flufenacet and its metabolites containing the 4-fluoro- *N* -methylethyl benzenamine moiety in or on grass (forage, hay), sweet corn (forage, kernel plus cob with husk removed, stover), wheat (bran, forage, grain, hay, straw), cattle kidney, goat kidney, hog kidney, horse kidney, and sheep kidney. Bayer Cropscience petitioned EPA to establish these tolerances. DATES: This regulation is effective May 9, 2007. Objections and requests for hearings must be received on or before July 9, 2007, 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-2006-0965. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-5697; e-mail address: *tompkins.jim@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), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. 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-2006-0965 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 July 9, 2007. 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-2006-0965, 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of December 20, 2006 (71 FR 76321) (FRL-8104-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F6095) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.527 be amended by establishing a tolerance for combined residues of the herbicide flufenacet ( *N* -(4-fluorophenyl)- *N* -(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl] oxy] acetamide and its metabolites containing the 4-fluoro- *N* -methylethyl benzenamine moiety in or on the food commodities: corn, sweet, forage at 0.4 parts per million (ppm); corn, sweet, kernel plus cob with husks removed at 0.05 ppm; corn, sweet, stover at 0.4 ppm; wheat, forage at 10.0 ppm; wheat, grain at 1.0 ppm; wheat, hay at 2.0 ppm; wheat, straw at 0.5 ppm; seed-grass, forage at 7.0 ppm; seed-grass, forage, regrowth at 0.1 ppm; seed-grass, hay, regrowth at 0.5 ppm. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received in response to the notice of filing. After completing a review of the submitted data, the Agency determined that additional tolerances are needed in connection with the petitioned-for tolerances for wheat bran 0.80 ppm, grass forage at 7.0 ppm, and grass hay at 0.4 ppm, cattle kidney at 0.05 ppm, goat kidney at 0.05 ppm, hog kidney at 0.05 ppm, horse kidney at 0.05 ppm, and sheep kidney at 0.05 ppm. EPA determined that tolerance levels are needed that differ from those proposed by the registrant for sweet corn forage at 0.45 ppm (0.4 ppm proposed) sweet corn stover at 0.30 ppm, (0.4 ppm proposed) wheat forage at 6.0 ppm (10.0 ppm proposed), wheat grain at 0.60 ppm (1.0 ppm proposed), wheat hay at 1.2 ppm (2.0 ppm proposed), and wheat straw at 0.35 ppm (0.5 ppm proposed). EPA determined that tolerances are not necessary for fat, meat, and meat byproducts of cattle, goat, hog, horse, and sheep. Since permanent tolerances are being established for wheat and kidney of cattle, goat, hog, horse, and sheep, emergency exemption tolerances for these commodities are being deleted. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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 FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing 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. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of flufenacet. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies 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. Specific information on the studies received and the nature of the toxic effects caused by flufenacet as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* in the document, entitled *Flufenacet: HED Human Health Risk Assessment for Uses on Wheat, Perennial Grasses Grown for Seed and Sweet Corn* which is in the docket for this rule. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for flufenacet used for human risk assessment can be found in Table 4 (p.14) of the document, entitled *Flufenacet: HED Human Health Risk Assessment for Uses on Wheat, Perennial Grasses Grown for Seed and Sweet Corn* which is in the docket for this rule. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.527) for the combined residues of flufenacet and its metabolites, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from flufenacet in food from existing and proposed tolerances as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the U.S. Department of Agriculture
(USDA)1994-1996 and 1988 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Anticipated residues for many crops (field corn, soybean, sweet corn, and wheat) were developed using field trial data. Anticipated residues for livestock commodities were derived using available feeding and metabolism studies in conjunction with the anticipated dietary burden to ruminants, swine and poultry. Tolerance level residues were used to assess flufenacet exposure from the remaining commodities (i.e., cereal grains other than wheat). Exposure estimates for all commodities were further refined using percent crop treated
(PCT)data. Projected PCT data were used to refine anticipated residues for the new food uses (sweet corn and wheat). Available processing data were used to refine anticipated residues for cereal grains and corn. For all other processed commodities, DEEM (ver. 7.81) default processing factors were assumed. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Anticipated residues for many crops (field corn, soybean, sweet corn, and wheat) were developed using field trial data. Anticipated residues for livestock commodities were derived using available feeding and metabolism studies in conjunction with the anticipated dietary burden to ruminants, swine and poultry. Tolerance level residues were used to assess flufenacet exposure from the remaining commodities (i.e., cereal grains). Exposure estimates for all commodities were further refined using PCT data. Projected PCT data were used to refine anticipated residues for the new food uses (sweet corn and wheat). Available processing data were used to refine anticipated residues for cereal grains and corn. For all other processed commodities, DEEM (ver. 7.81) default processing factors were assumed. iii. *Cancer* . A cancer aggregate exposure assessment was not performed because flufenacet is not carcinogenic. iv. *Anticipated residue and PCT information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant section 408(f)(1) of FFDCA require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Chronic and acute dietary exposure analyses for sweet corn were based on projected PCT when treated with flufenacet of an average of 3% (used for chronic exposure assessment) and a maximum of 10% (used for acute exposure assessment). These projected PCT estimates were based on the following. Flufenacet has been registered and used on field corn since 1998. Field corn and sweet corn are the same species and there are many weeds and herbicides used to control those weeds which are common to the two crops. Therefore the use of flufenacet on field corn was used as the basis for predicting flufenacet use on sweet corn. EPA also analyzed other factors based on available information that included more recent usage of other acetamide herbicides on both field corn and sweet corn, information on new products desired for sweet corn, including flufenacet, to combat newly invasive weeds and resistant weeds, and differences in importance of individual herbicides between field corn and sweet corn. Chronic and acute dietary exposure analyses for wheat were based on projected PCT when treated with flufenacet of an average of 1% and a maximum of 3%. These projected PCT estimates were based on the following: Emergency exemption uses have been issued for flufenacet on wheat for several years. EPA initially estimated the PCT for wheat based on recent PCTs for winter wheat due to emergency exemption usage. EPA later examined acres treated in individual states and compared that information to the treatment acres permitted under the emergency exemptions. EPA also analyzed other factors based on available information that included usage of metribuzin on winter wheat (since a new use is the combination metribuzin and flufenacet), current and past Emergency Exemption requests for flufenacet in the Northwest and on the East Coast to control resistant Italian ryegrass, and more recent usage data. For all other commodities, PCT estimates were based on a screening level usage analysis of pesticide usage data from the following sources: • USDA-NASS (United States Department of Agriculture’s National Agricultural Statistics Service)—pesticide usage data from 1998 to 2003. • NCFAP (National Center for Food and Agricultural Policy—pesticide usage data from 1997 and is only used if data is not available from the other sources. • Private pesticide market research—pesticide usage data from 1998 to 2004. The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA finds that the PCT information described above for flufenacet on sweet corn, wheat, and grass forage and other commodities with existing registrations for flufenacet is reliable and has a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which flufenacet may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for flufenacet in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of flufenacet. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppfeed1/models/water/index* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of flufenacet (plus its degradate thiadione in surface water) for acute exposures are estimated to be 8.64 parts per billion
(ppb)for surface water and 0.10 ppb for ground water. The EECs for chronic exposures are estimated to be 2.23 ppb for surface water and 0.10 ppb for ground water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flufenacet is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” 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 flufenacet and any other substances and flufenacet 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 flufenacet 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* . D. Safety Factor for Infants and Children 1. *In general* . 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 on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no indication of additional susceptibility of young rats or rabbits following prenatal exposure to flufenacet in the developmental toxicity studies. There was an indication of qualitative susceptibility in the 2-generation reproduction study. Effects seen in the offspring in the reproductive toxicity studies (including increased pup death in early lactation and cannibalism) were more severe than those seen in the parental animals (increased liver weight and cytomegaly), although there was no difference in the NOAELs/LOAELS between parental animals and offspring in that study. Increased susceptibility (qualitative and quantitative) was seen in the developmental neurotoxicity study in rats. Decreased body weight was seen in pups at all dose levels, and additional effects, including decreased motor activity, delayed developmental landmarks, and decreases in morphometric measurements were seen at mid and high doses. Morphometric measurements were not made at the low dose. A slight decrease in body weight in mid and high dose dams during early lactation may have been due to palatability of test substance and was not considered adverse. The selection of 1.7 milligrams/kilograms/day (mg/kg/day) as a LOAEL for the developmental neurotoxicity study is considered to be a conservative recommendation as to the decreased body weight effect, because the decrease in pup body weight at that dose is transient, and a similar decrease was not seen in the 2-generation reproduction study (decreased pup body weight seen in the 1-generation range-finding reproduction study occurred at higher doses than those evaluated in the developmental neurotoxicity study). 3. *Conclusion* . Several factors weighed in favor of the conclusion that no additional safety factor is needed to protect the safety of infants and children. First, there was no evidence of increased susceptibility in the developmental toxicity studies (rats and rabbits), and qualitative susceptibility seen in the rat reproduction study did not raise concerns because the pup death may be attributable to maternal cannibalism, and there was a clear NOAEL for the effect. Second, there are also no additional residual uncertainties with respect to exposure data: • The dietary drinking water assessment utilizes water concentration values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which will not likely be exceeded. • Although the exposure assessment from pesticide residues in food was somewhat refined, the assessment is based on reliable data and will not underestimate exposure/risk. • There are no residential uses for flufenacet. Nonetheless, for several reasons EPA determined that the 10X FQPA Safety Factor should be retained. The primary reason for retaining the additional safety factor is that there is uncertainty regarding the protectiveness of selected RfDs because of a lack of comparative susceptibility data for thyroid hormone levels. Secondarily there is also some uncertainty due to the lack of a NOAEL in the DNT for the decrease in morphometric measurements and body weight effects in pups and the lack of data on comparative sensitivity to neuropathologic lesions. Concerns with regard to these latter issues are more limited given dose response data on the morphometric changes indicating that these effects would not be expected at the low dose, the transient nature of the body weight effects seen at the low dose, and the fact that neuropathologic lesions were only seen at relatively high doses. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food plus drinking water to flufenacet will occupy 30% of the aPAD for the U.S. population, 25% of the aPAD for females 13 years and older, 89% of the aPAD for all infants (< 1 year old), and 42% of the aPAD for children 1-2 years old. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flufenacet from food plus drinking water will utilize 2.9% of the cPAD for the U.S. population, 9.2% of the cPAD for all infants (< 1 year old), and 4.4% of the cPAD for children 1-2 years old. There are no residential uses for flufenacet that result in chronic residential exposure to flufenacet. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flufenacet is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flufenacet is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . Because flufenacet is classified as a “not likely” carcinogen, the Agency does not expect exposure to flufenacet to result in any cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to flufenacet residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatographic/single ion mode (GC/SIM) common moiety method) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits Flufenacet is not in the Codex system, i.e., there are no established or pending Codex MRLs for flufenacet. Therefore, there are no harmonization issues. V. Conclusion Therefore, the tolerances are established for combined residues of flufenacet, ( *N* -(4-fluorophenyl)- *N* -(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl] oxy] acetamide and its metabolites containing the 4-fluoro- *N* -methylethyl benzenamine moiety, in or on grass forage at 7.0 ppm, grass hay at 0.4 ppm, sweet corn forage at 0.45, sweet corn kernel plus cob with husk removed at 0.05 ppm, sweet corn stover at 0.30 ppm, wheat bran at 0.80 ppm, wheat forage at 6.0 ppm, wheat grain at 0.60 ppm, wheat hay at 1.2 ppm, wheat straw at 0.35 ppm, cattle kidney at 0.05 ppm, goat kidney at 0.05 ppm, hog kidney at 0.05 ppm, horse kidney at 0.05 ppm, and sheep kidney at 0.05 ppm. Section 18 emergency exemption tolerances are deleted for flufenacet in or on wheat (forage, grain, hay, straw) and fat, kidney, meat, and meat byproducts of cattle, goat, hog, horse, and sheep. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of 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 FFDCA, such as the tolerance 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 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. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., 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 final 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 final rule in the **Federal Register** . This final 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: May 1, 2007. 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 180.527 is amended as follows: i. By revising the section heading; ii. By revising paragraph (a); iii. By removing the text of paragraph
(b)and reserving with heading; iv. By revising the introductory text of paragraph
(c)and adding commodities to the table; and v. By revising the introductory text of paragraph (d). The amendments read as follows: § 180.527 Flufenacet, N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] oxy]acetamide and its metabolites containing the 4-fluoro-N-methylethyl benzenamine tolerances for residues.
(a)*General* . Tolerances are established for the combined residues of the herbicide flufenacet, *N* -(4-fluorophenyl)- *N* -(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] oxy]acetamide and its metabolites containing the 4-fluoro- *N* -methylethyl benzenamine moiety in or on the following commodities. Commodity Parts per million Cattle, kidney 0.05 Corn, field, forage 0.4 Corn, field, grain 0.05 Corn, field, stover 0.4 Corn, sweet, forage 0.45 Corn, sweet, kernel plus cob with husks removed 0.05 Corn, sweet, stover 0.30 Goat, kidney 0.05 Hog, kidney 0.05 Horse, kidney 0.05 Sheep, kidney 0.05 Soybean, seed 0.1 Wheat, bran 0.80 Wheat, forage 6.0 Wheat, grain 0.60 Wheat, hay 1.2 Wheat, straw 0.35
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . Tolerances are established for combined residues of flufenacet, *N* -(4-fluorophenyl)- *N* -(1-methylethyl)-2-[[5-(trifluoromethyl)-1, 3, 4-thiadiazol-2-yl] oxy]acetamide, and its metabolites containing the 4-fluoro- *N* -methylethyl benzenamine moiety, with regional registration. Commodity Parts per million Grass, forage 7.0 Grass, hay 0.4
(d)*Indirect or inadvertent residues* . Tolerances are established for indirect or inadvertent residues of the herbicide flufenacet, *N* -(4-fluorophenyl)- *N* -(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide and its metabolites containing the 4-fluoro- *N* -methylethyl benzenamine moiety in or on the following raw agricultural commodities when present therein as a result of application of flufenacet to the growing crops in paragraph
(a)of this section. [FR Doc. E7-8936 Filed 5-8-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0535; FRL-8127-2] Clethodim; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of clethodim and certain of its metabolites in or on asparagus; flax, seed; herb, subgroup 19A; hop, dried cones; leafy greens subgroup 4A; safflower, meal; safflower, seed; sesame, seed; and vegetable, legume, group 6, except soybean. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective May 9, 2007. Objections and requests for hearings must be received on or before July 9, 2007, 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-2005-0535. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., 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: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-7610; e-mail address: *jackson.sidney@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 those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide 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 EPA's tolerance regulations at 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, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2005-0535 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 as required by 40 CFR part 178 on or before July 9, 2007. 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 this copy, identified by docket ID number EPA-HQ-OPP-2005-0535, 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 Bldg.), 2777 S. Crystal Dr., 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. Petition for Tolerance In the **Federal Register** of April 21, 2006 (71 FR 20669) (FRL-8056-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 3E6555, 5E6977, 4E6836, 5E6978, and 4F6895) by the Interregional Research Project #4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.458 be amended by establishing a tolerance for combined residues of the herbicide clethodim, (E)-(±)-2-[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one and its metabolites containing the 2-cyclohexene-1-one moiety in or on flax, seed at 0.5 parts per million
(ppm)(PP 3E6555); herb, subgroup 19A at 10.0 ppm (4E6836); asparagus at 2.0 ppm and hop, dried cones at 0.5 ppm (5E6977); leafy greens subgroup 4A at 2.0 ppm (5E6978); and sesame, seed at 0.40 ppm; vegetable, legume, group 6 at 3.0 ppm; safflower, meal at 10.0 ppm; and safflower, seed at 5.0 ppm (4F6895). That notice referenced a summary of the petitions prepared by Valent U.S.A. Corporation, 133 N. California Blvd., Walnut Creek, CA 94596, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has recommended certain changes to the petitions including: • Revised tolerance levels for certain commodities, and: • A specific tolerance expression to be applied to all new uses in an effort to harmonize tolerances with Codex Maxium Residue Limits. The reasons for these changes are explained in Unit V. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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(b)(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 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. . . .” These provisions were added to the FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned for tolerances for combined residues of clethodim on flax, seed at 0.6 ppm; herb, subgroup 19A at 12.0 ppm (4E6836); asparagus at 1.7 ppm and hop, dried cones at 0.5 ppm; leafy greens subgroup 4A at 2.0 ppm (5E6978); and sesame, seed at 0.35 ppm; vegetable, legume (except soybean), group 6 at 3.5 ppm; safflower, meal at 10.0 ppm; and safflower, seed at 5.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies 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. Specific information on the studies received and the nature of the adverse effects caused by clethodim as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The referenced document is available in the docket established by this action, which is described under ADDRESSES , and is identified as “Clethodim: Human Health Risk Assessment for Proposed Uses on Herb Sugbroup 19A, Leafy Greens......and Flax seed, dated 03/07/2007” in that docket. Additionally, clethodim toxicological data are discussed in the final rule published in the **Federal Register** of March 14, 2001(66 FR 14829) (FRL-6770-8). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which NOAELs are observed in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL of concern identified is sometimes used for risk assessment. Uncertainty/safety factors
(UF)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for clethodim used for human risk assessment can be found at *www.regulations.gov* in document “Clethodim: Human Health Risk Assessment for Proposed Uses on Herb Sugbroup 19A, Leafy Greens......and Flax seed, dated 03/07/2007” at page 14 in Docket ID EPA-HQ-OPP-2005-0535. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to clethodim, EPA considered exposure under the petitioned-for tolerances as well as all existing clethodim tolerances in (40 CFR 180.458). EPA assessed dietary exposures from clethodim in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for clethodim; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary (food and water) exposure assessment, EPA used the food consumption data from the U.S. Department of Agriculture's
(USDA)Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) from 1994-1996 and 1998. The chronic dietary exposure assessment was based on the assumption of tolerance-level residues for existing and proposed tolerances; and incorporated percent crop treated
(PCT)information for certain registered uses. iii. *Cancer* . Clethodim was negative for carcinogenicity in feeding studies in rats and mice and was classified as “not likely” to be a human carcinogen. Therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary. iv. *Anticipated residue and PCT information* . Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if: a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Commodity Percent of Crop Treated (Weighted Average) Beets 1 Broccoli 10 Cabbage 1 Cantaloupes 1 Carrots 10 Celery 5 Cotton 1 Cucumbers 1 Dry beans 5 Lettuce 1 Onions 10 Peanuts 5 Potatoes 5 Pumpkins 5 Soybeans 5 Squash 5 Strawberries 1 Sugar beets 45 Sunflowers 20 Sweet potatoes 1 Tomatoes 1 Watermelons 5 EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases < 1% is used as the average and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent six years. The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from sources as discussed above including Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which clethodim may be applied in a particular area. 2. *Dietary exposure from drinking water* .The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for clethodim in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of clethodim. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Surface water and ground water contamination may occur from the sulfoxide and sulfone degradates of clethodim, as well as from parent clethodim. However, the risk of water contamination is primarily associated with clethodim sulfone and clethodim sulfoxide rather than parent clethodim based on greater persistence and mobility for these degradates. Parent clethodim may move from the treated field to surface water or ground water through run-off or leaching which occurs shortly after application (e.g. rainfall). Also, the sulphoxide and sulphone degradates may migrate by runoff or leaching for longer periods of time since they are more persistent. All residues of clethodim (parent and degradates) are very mobile in soil. The only significant routes of dissipation of clethodim are microbial degradation in soil and movement by leaching or runoff. Parent clethodim is moderately persistent to hydrolysis at pH 5 with half-lives of 26-42 days and stable at pH 7 and 9 with half-lives greater than 300 days. Even though acceptable water and soil photolysis studies show half-lives of 1.5 to 9.3 days, this may not be an important route of dissipation because of suspended sediment and shading. Photolysis is only an important route of dissipation in shallow, well-mixed surface water with no shading. The half-lives in aerobic soil are 2-3 days for parent clethodim, and 30-38 days for total toxic residues (parent + sulphoxide + sulphone). The sulphoxide and sulphone metabolites are more persistent than parent clethodim and are formed in significant quantities in soil. All residues of clethodim (parent and metabolites) are very mobile in soil with five out of six soil desorption coefficients
(Kd)less than one. The field dissipation studies show that parent clethodim was only found at levels at or near the quantitation limit of 0.02 ppm, which is consistent with the rapid degradation in soil. Clethodim sulphoxide had an apparent half-life of 2.5 to 3.7 days, indicating that movement from the treated field may have been an important route of dissipation. In surface water, parent clethodim may move from the treated field to surface water or ground water through run-off or leaching which occurs shortly after application (e.g. rainfall). Also, the sulphoxide and sulphone degradates may migrate by runoff or leaching for longer periods of time since they are more persistent. All residues of clethodim (parent and degradates) are very mobile in soil. In ground water, parent clethodim is mobile, but has a short metabolic half-life in soil under aerobic conditions. Therefore, parent compound should not be a ground water concern in most environments. While it is expected that parent clethodim can be transformed to sulphoxide or sulphone products quickly by soil metabolism (t½ = 1 - 3 days), it may be more persistent since it is leached below the more biologically active top soil. In such instances (i.e., leaching rainfall shortly after application) parent clethodim concentrations may be higher than estimated and correspondingly, the concentration of the degradates sulphoxide and sulphone would be lower. In the event that parent clethodim did reach ground water, the available routes of disappearance would be dilution, some metabolism to persistent degradates, and slow hydrolysis with the rate depending on the pH of the ground water. Estimates are provided for both parent clethodim and total toxic clethodim (parent + sulphoxide + sulphone). Based on the (FQPA Index Reservoir Screening Tool (FIRST)) model, Tier 1 surface water concentrations for parent clethodim and total toxic residues (parent + sulphoxide + sulphone) were estimated in drinking water. These estimates are based on a maximum application rate of 0.5 lb ai/acre per year (2 applications). The peak FIRST estimated environmental concentration
(EEC)for clethodim and it's degradates, sulphoxide and sulphone for acute exposures are estimated to be 38.9 parts per billion
(ppb)for surface water. The EECs for chronic exposures are estimated to be 7.6 ppb for surface water. For drinking water derived from ground water, the Screening Concentration in Ground water (SCI-GROW) model estimates a total toxic clethodim concentration of 1.39 ug/L sources were not included, as the EEC's for this water source are minimal in comparison to surface water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 38.9 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 7.6 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Although clethodim is registered for use in non-crop areas and for commercial use on ornamentals, no residential exposure is expected from these uses because these uses are clearly intended for commercial and institutional applications on commercially grown ornamentals and not for ornamentals in a residential setting. Therefore, non-occupational exposure assessment of clethodim was not performed. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” 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 clethodim and any other substances and clethodim 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 clethodim 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* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional
(10X)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 based on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no evidence of susceptibility following *in utero* and/or postnatal exposure to clethodim in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study. There are no residual uncertainties concerning pre- and postnatal toxicity and no neurotoxicity concerns. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity data base for clethodim is complete. ii. There is no indication that clethodim is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. There is no evidence that clethodim results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary (food and drinking water) exposure assessment will not underestimate the potential exposure for infants, children, and/or women of childbearing age. There is no potential for residential exposure. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . There were no effects observed in oral toxicity studies including developmental toxicity studies in rats and rabbits that could be attributable to a single dose (exposure). Therefore, clethodim is not expected to pose an acute risk. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clethodim from food and water will utilize 29% of the cPAD for the general U.S. population group and 84% of the cPAD for children 1-2 years old, the subpopulation group with greatest exposure. There are no residential uses for clethodim that result in chronic residential exposure to clethodim. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clethodim is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water which do not exceed the Agency's level of concern. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clethodim is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . Clethodim is classified as a “not likely” to be carcinogenic in humans based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in the rat. Therefore, clethodim is not expected to pose a cancer risk to humans. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to clethodim residues. IV. Other Considerations A. Analytical Enforcement Methodology For plants, adequate methodology is available for enforcement of the proposed tolerances through the use of FDA Multiresidue Methods. The analytical method used to assay clethodim residues in/on commodities that are the subject of this action was RM-26B-3 (a modification of RM-26B-2) or RE 45601 (also adapted from Valent (the registrant) method RM-26B), which was validated for the analyses of residues of clethodim sulfoxide and its metabolite (5-hydroxy clethodim sulfone) in/on green onions, leaf lettuce, and cabbage. Samples were analyzed for combined clethodim residues (dimethylester sulfone
(DME)and 5-hydroxy dimethylester sulfone (DME-OH)) by gas chromatography with flame photometric detection in the sulfur mode (GC/FPD-S). In the analytical results, DME and DME-OH were reported as clethodim equivalents. Only one crop, hops, dried cones, had residues below the limit of quantitation
(LOQ)< 0.50 ppm) for combined total residues of clethodim (DME and DME-OH). The concurrent recoveries of clethodim (DME and DME-OH) for the submitted trials were generally within the accepted range of 70-120%. An exception was the concurrent recovery of DME-OH in succulent pea at 62%. There is no reason to believe that the residues of clethodim were unstable, or that the analytical method was not reliable under the conditions of these studies. For livestock, Analytical Method RM-26B-3 (a modification of RM-26B-2) has been successfully validated for use with livestock commodities and has been submitted to the FDA for publication in PAM II. IR-4 (petitioner) has previously submitted data describing the testing of clethodim and its metabolites through FDA Multiresidue Methods. These data, which have been forwarded to FDA for review indicate that adequate recoveries of clethodim, clethodim sulphoxide, and 5-OH clethodim sulphone have been obtained under FDA's multiresidue protocols. Accordingly, EPA concludes that Adequate enforcement methodology (GC/FPD-S) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are currently Codex MRLs established for clethodim and its metabolites containing 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, expressed as clethodim, in or on bean, dry at 2 ppm; beans, except broad bean and soya bean at 0.5 ppm; field peas
(dry)at 2 ppm; and soya bean
(dry)at 10 ppm. Based on newly submitted field trial data, the Agency is establishing a new crop group tolerance, i.e., on vegetables, legume, group (crop group 6), except soybean. Because the Agency is establishing the tolerances on legume vegetables as a crop group, it cannot harmonize the crop group tolerance with the varying Codex MRLs for individual legume vegetables. There are established Canadian MRLs for clethodim residues and its metabolites containing the 2-cyclohex-1-enone moiety on soybean at 10.0 ppm, beans, 0.5, chickpea at 0.5 ppm; lentils at 0.5 ppm; pea, dry at 0.5 ppm and flax seed at 0.3 ppm. In addition, Mexican MRLs are established for clethodim on bean, kidney at 2.0 ppm and soya bean at 10 ppm. Harmonization with Canadian and Mexican MRLs is not possible based on the MRL calculations of the newly submitted data. V. Conclusion The Agency has revised the proposed tolerance expression to make it consistent with the existing tolerance expression in 40 CFR 180.458 (a)(3). Clethodim is defined as the combined residues of clethodim and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones. In addition, the Agency revised tolerance levels proposed by IR-4 for certain commodities to reflect tolerance levels supported by current data bases. Therefore, tolerances are established for the combined residues of the herbicide clethodim, (E)-(±)-2-[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one and its metabolites containing the 5-(2-ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5-hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones in or on flax, seed at 0.6 ppm; herb, subgroup 19A at 12.0 ppm; asparagus at 1.7 ppm; hop, dried cones at 0.5 ppm; leafy greens subgroup 4A at 2.0 ppm; and sesame, seed at 0.35 ppm; vegetable, legume group 6, except soybean at 3.5 ppm; safflower, meal at 10.0 ppm; and safflower, seed at 5.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of 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, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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* ., 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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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). 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). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 final rule in the **Federal Register** . This final 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: May 1, 2007. 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 180.458 is amended by alphabetically adding the following commodities to the table in paragraph (a)(3) to read as follows: § 180.458 Clethodim; tolerances for residues.
(a)* * *
(3)* * * Commodity Parts per million Asparagus 1.7 * * * * * Flax seed 0.6 * * * * * Herb subgroup 19A 12.0 * * * * * Hop, dried cones 0.5 * * * * * Leafy greens subgroup 4A 2.0 * * * * * Safflower, meal 10.0 Safflower, seed 5.0 Sesame, seed 0.35 * * * * * Vegetable, legume group 6, except soybean 3.5 [FR Doc. E7-8938 Filed 5-8-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0237; FRL-8127-3] Fenpyroximate; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for combined residues of fenpyroximate in or on honey. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide in managed beehives. This regulation establishes a maximum permissible level for residues of fenpyroximate in this food commodity. The tolerance expires and is revoked on December 31, 2010. DATES: This regulation is effective May 9, 2007. Objections and requests for hearings must be received on or before July 9, 2007, 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-2007-0237. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. 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 either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-2505; e-mail address: *groce.stacey@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 Federal Food, Drug, and Cosmetic Act (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-2007-0237 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 July 9, 2007. 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-2007-0237 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is
(703)305-5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a time-limited tolerance for combined residues of the miticide fenpyroximate in or on honey at 0.10 parts per million (ppm). This tolerance expires and is revoked on December 31, 2010. EPA will publish a document in the **Federal Register** to remove the revoked tolerance from the Code of Federal Regulations (CFR). Section 408(l)(6) of the FFDCA requires EPA to establish a tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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(b)(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 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. . . .” Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Fenpyroximate on Honey and FFDCA Tolerances The varroa mite, ( *Varroa jacobsoni* ), is an ectoparasite of honeybees. It was first detected in the continental United States in 1979 and is currently the most important pest of honey bee colonies. The feeding of varroa mites has a number of effects on the bee from damaging tissue to shortening the bee's life span as an adult. Further, the mites vector disease viruses and heavy levels of parasitism increase bee mortality and weaken colonies. Fluvalinate is currently registered for the control of varroa mites; however, populations of varroa mites have developed resistance to fluvalinate. The applicants for this use pattern assert that the continued survival of managed bee colonies is critical to the production of many agricultural crops and it is becoming increasingly difficult to control varroa mites due to pesticide resistance. EPA has authorized under FIFRA section 18 the use of fenpyroximate on honey for control of varroa mites in Nebraska, North Dakota, New York, Idaho, Oregon, and Washington States. In addition, EPA has authorized under the FIFRA section 18 crisis provision the use of fenpyroximate in beehives for control of varroa mites in Texas. After having reviewed the submission, EPA concurs that emergency conditions exist for these States. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of fenpyroximate in or on honey. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this time-limited tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this time-limited tolerance expires and is revoked on December 31, 2010, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on honey after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this time-limited tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether fenpyroximate meets EPA's registration requirements for use on honey or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of fenpyroximate by a State for special local needs under FIFRA section 24(c). Nor does this time-limited tolerance serve as the basis for any States other than Idaho, Nebraska, Minnesota, New York, North Dakota, Texas, and Washington States to use this pesticide on bee hives under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for fenpyroximate contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . 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. EPA has sufficient data to assess the hazards of fenpyroximate and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for combined residues of fenpyroximate in or on honey at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows. A. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure
(MOE)= NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 X 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE <sup>cancer</sup> = point of departure/exposures) is calculated. A summary of the toxicological endpoints for fenpyroximate used for human risk assessment is discussed in Table 1 on page 5 of the Fenpyroximate Human Health Risk Assessment dated December 4, 2006: *Section 18 Request for Use in Bee Hives* , and can be located by searching for docket ID number EPA-HQ-OPP-2007-0237. Double-click on the document to view the referenced information. B. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.566) for the combined residues of the miticide fenpyroximate in or on a variety of raw agricultural commodities. Tolerances have also been established for fenpyroximate and its metabolites (E)-4-[(1,3-dimethyl-5-phenoxypyrazol-4-yl)-methylene aminooxymethyl] benzoic acid and (E)-1,1-dimethylethyl-2-hydroxyethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1 H-pyrazol-4-yl) methylene] amino]oxy]methyl]benzoate, calculated as the parent compound at 0.015 ppm in milk, and the fat, meat, and meat byproducts (excluding liver and kidney) of cattle, goat, horse, and sheep at 0.03 ppm. Risk assessments were conducted by EPA to assess dietary exposures from fenpyroximate in food as follows: i. *Acute exposure.* Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEM-FCID TM ) version 2.02 analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An unrefined Tier I acute dietary-exposure assessment was conducted for females 13-49 years old. The unrefined Tier I acute dietary analyses assumed that fenpyroximate residues were present in all commodities at tolerance levels and that 100% of all commodities (registered and proposed uses) are treated. Adequate processing data on apples, grapes, oranges, and mint are available. Modified processing factors based on these data were used for apple juice, pear juice, grape juice, raisins, citrus juice (orange, grapefruit, lemon, lime) and mint oils (peppermint and spearmint). The DEEM-FCID TM default processing factors were used for all other processing commodities. ii. *Chronic exposure* . In conducting this chronic dietary risk assessment the DEEM-FCID TM version 2.02 analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: An unrefined Tier I chronic dietary-exposure assessment was conducted for the general U.S. population and various sub-populations. The unrefined Tier I chronic dietary analyses assumed that fenpyroximate residues were present in all commodities at tolerance levels and that 100% of all commodities (registered and proposed uses) are treated. Adequate processing data on apples, grapes, oranges, and mint are available. Modified processing factors based on these data were used for apple juice, pear juice, grape juice, raisins, citrus juice (orange, grapefruit, lemon, lime) and mint oils (peppermint and spearmint). The DEEM-FCID TM default processing factors were used for all other processing commodities. iii. *Cancer* . Fenpyroximate is classified as “not likely” to be a human carcinogen. Therefore a cancer risk assessment was not performed. 2. *Dietary exposure from drinking water* . The Agency determined that in addition to the parent compound, known as fenpyroximate, M-1, the z isomer of fenpyroximate, and the M-3 metabolite should be included in the drinking water assessment for fenpyroximate based on their structural similarity. Some surface water and ground water contamination may occur based on the proposed application rates and the environmental fate properties of fenpyroximate. However, the risk of water contamination from the parent compound is relatively low, based on its high sorption potential. Unlike the parent compound, sorption of the M-3 metabolite is much less, and it may move into water resources more readily. Fenpyroximate and M-1 are not expected to persist under terrestrial environmental conditions, with metabolism as the primary route of dissipation. Hydrolysis and photodegradation on soil are not expected to be significant routes of dissipation, but photodegradation in water could be significant assuming clear, well-mixed, shallow water bodies. Based on Tier II screening-level surface water modeling for drinking water, the Agency estimated concentrations in surface water to be used for acute, chronic non-cancer, and cancer exposure assessment. Tier II surface water concentrations for parent fenpyroximate and M-1 were calculated using the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM-EXAMS) shell. The acute and chronic non-cancer concentrations for Georgia
(GA)pecan (highest exposure) are 12.9 and 1.8 microgram/Liter (ug/L), respectively. EPA used the Screening Concentration Ground Water (SCI-GROW2) model to estimate a ground water concentration of 0.059 parts per billion (ppb). These results for both surface water and ground water are consistent with the fate and transport properties of fenpyroximate. Modeled estimates of drinking water concentrations were incorporated directly into the dietary assessment using the estimated drinking water concentrations
(EDWC)for surface water generated by the PRZM-EXAMS model. For the acute assessment, the peak concentration of 12.9 ppb was used to assess the contribution to drinking water; for the chronic assessment, the annual mean value of 1.8 ppb was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fenpyroximate is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” 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 fenpyroximate and any other substances and fenpyroximate 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 fenpyroximate 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/* . C. Safety Factor for Infants and Children 1. *In general* . 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 database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The rat and rabbit developmental toxicity studies were tested at doses that produced minimal maternal toxicity. These doses were supported partly by range finding data. The 2-generation reproductive toxicity study indicated that maternal (decreased body weight) and offspring toxicity (decreased lactational weight gain) occurred at the same dose, suggesting no evidence of increased sensitivity or susceptibility. Reproductive parameters were not affected in this 2-generation reproduction study. There are no neurotoxicity studies other than a negative delayed acute neurotoxicity study in the hen. There was no indication of neurotoxicity present in any of the existing subchronic or chronic toxicity studies. The toxicology database is complete for FQPA purposes and there are no residual uncertainties for prenatal/postnatal toxicity. 3. *Conclusion* . There is a complete toxicity database for fenpyroximate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be changed to 1X for the following reasons: i. There are no concerns or residual uncertainties for prenatal or postnatal toxicity. ii. The toxicological database is complete for the assessment of toxicity and susceptibility following prenatal and/or postnatal exposures. No clinical signs of neurotoxicity or neuropathology were observed in the database. iii. There are no residual concerns regarding completeness of the exposure database. iv. The dietary food exposure assessment is an unrefined, Tier I, acute and chronic analyses, which assumed that fenpyroximate residues were present in all commodities at tolerance levels and that 100% of all commodities (registered and proposed uses) were treated with fenpyroximate. By using these screening level assessments, actual exposures /risks will not be underestimated. v. The dietary drinking water assessment utilizes water concentration values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations that will not likely be exceeded. vi. There are currently no registered or proposed residential uses of fenpyroximate. D. Aggregate Risks and Determination of Safety The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs), which are used as a point of comparison against estimated drinking water concentrations (EDWCs). The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. More information on the use of DWLOCs in dietary aggregate risk assessments can be found at *http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf* . More recently, the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface water and ground water EDWCs are directly incorporated into the dietary exposure analysis, along with food. This approach provides a more realistic estimate of exposure because actual body weights and water exposures are then added to estimated and water consumption form the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs. The risk assessment for fenpyroximate used in this tolerance document uses this approach of incorporating water exposure directly into the dietary exposure analysis. There are no registered or proposed uses of fenpyroximate, which result in residential exposures, so the aggregate exposure assessment required by FFDCA section 408(b)(2)(D)(vi) consists solely of dietary (food + drinking water) exposures. Aggregate exposure risk assessments were conducted by incorporating the drinking water concentrations directly into the dietary exposure assessment for the acute and chronic aggregate exposures (food + drinking water). These aggregate exposures do not exceed the Agency's level of concern since they were less than 100% of the respective population adjusted doses (PADs). 1. *Acute risk* . An unrefined acute dietary-exposure assessment was conducted for females 13 to 49 years old. Since an effect of concern attributable to a single dose in toxicity studies was not identified for the general U.S. population, an acute dietary-exposure assessment was not performed for this population. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fenpyroximate will occupy 6.8% of the acute population adjusted dose
(aPAD)for females 13 years and older. EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions discussed in this unit for chronic exposure, EPA has concluded that exposure to fenpyroximate from food and water will utilize 9.8% of the chronic population adjusted dose
(cPAD)for the U.S. population, 20% of the cPAD for all infants, 1 year old, and 34% of the cPAD for children 1 to 2 years old. There are no residential uses for fenpyroximate which result in chronic residential exposure to fenpyroximate. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Aggregate cancer risk for U.S. population* . A cancer aggregate-risk assessment was not performed because fenpyroximate has been classified as not likely to be carcinogenic to humans. 4. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fenpyroximate residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology and high-performance liquid chromatography/mass spectrometry/mass spectrometry (HPLC/MS/MS) is available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs)for the residues of fenpyroximate in honey. Therefore, there are no international harmonization concerns at this time. VI. Conclusion Therefore, the time-limited tolerance is established for combined residues of fenpyroximate, (E)-1,1-dimethylethyl 4-[[[(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl)methylene] amino]oxy]methyl]benzoate, in or on honey at 0.10 ppm. This tolerance expires and is revoked on December 31, 2010. VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of 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, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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* ., 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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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). 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). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 final rule in the **Federal Register** . This final 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: April 26, 2007. 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 180.566 is amended by adding text and a table to paragraph
(b)to read as follows: § 180.566 Fenpyroximate; tolerances for residues.
(b)*Section 18 emergency exemption* . Time-limited tolerance is established for the combined residues of fenpyroximate, (E)-1,1-dimethylethyl 4- [[[(E)-[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino]oxy] methyl]benzoate in or on honey at 0.10 ppm. This tolerance expires and is revoked on the date specified in the following table. Commodity Parts per million Expiration/revocation date Honey 0.10 ppm 12/31/2010 [FR Doc. E7-8954 Filed 5-8-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0880; FRL-8125-5] Foramsulfuron; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of foramsulfuron on corn, sweet (K+CWHR); corn, sweet, forage; corn, sweet, stover; corn, pop grain; and corn, pop, stover when applied/used as a herbicide. The Interregional Project Number 4 (IR-4) 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 foramsulfuron. DATES: This regulation is effective May 9, 2007. Objections and requests for hearings must be received on or before July 9, 2007, 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-2006-0880. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. 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 either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-3194; e-mail address: *brothers.shaja@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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in [insert appropriate cite to either another unit in the preamble or a section in a rule]. 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-2006-0880 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 July 9, 2007. 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-2006-0880, 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of November 22, 2006 (71 FR 67574) (FRL-8102-1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 5E7004) by IR-4, 500 College Road, East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.1219 be amended by establishing an exemption from the requirement of a tolerance for residues of foramsulfuron on corn, sweet (K+CWHR); corn, sweet, forage; corn, sweet, stover; corn, pop grain; and corn, pop, stover. This notice included a summary of the petition prepared by the registrant Bayer CropScience. There was one comment submitted by a private citizen who opposed the authorization to sell any pesticide that leaves a residue on food. The Agency has received this comment on numerous occasions and rejects it for the reason previously stated in the **Federal Register** of January 7, 2005, (70 FR 1349) (FRL-7694-3). 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) 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. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing 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....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of 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. The Agency determined the toxicological profile for foramsulfuron supports a tolerance exemption as result of the lack of toxicity associated with this chemical. For conclusive information on foramsulfuron's toxicity profile, please view the final rule published in the **Federal Register** of March 29, 2002 (67 FR 15120), (FRL-6829-8) ( *http://www.epa.gov/fedrgstr/EPA-PEST/2002/March/Day-29/p7502.htmtp* ). IV. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). Due to the low toxicity, it was determined that a dietary aggregate exposure risk assessment (food and water) is not needed. Therefore, an aggregate dietary assessment was not conducted. For more information on this determination, please view the final rule published in the **Federal Register** of March 29, 2002 (67 FR 15120), ( *http://www.epa.gov/fedrgstr/EPA-PEST/2002/March/Day-29/p7502.htmtp* ). V. Cumulative Effects Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information concerning the cumulative effects” of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” 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 foramsulfuron and any other substances, and foramsulfuron 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 foramsulfuron 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/* . VI. Safety Factor for the Protection of Infants and Children 1. *In general* . FFDCA section 408 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 database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure
(MOE)analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. Since a dietary risk assessment was not conducted for foramsulfuron due to its low toxicity, a safety factor for infants and children is not applicable to the determination of the risk due to exposure of infants and children to foramsulfuron. 2. *Prenatal and postnatal sensitivity* . No significant toxicity or prenatal or postnatal toxicity was seen in any of the studies conducted with foramsulfuron. 3. *Conclusion* . There is a complete toxicity database for foramsulfuron. Since a dietary risk assessment was not conducted for foramsulfuron due to its low toxicity, a safety factor for infants and children is not applicable to the determination of the risk due to exposure of infants and children to foramsulfuron. VII. Determination of Safety Based on the information in this preamble and the final rule published in the **Federal Register** of March 29, 2002 (67 FR 15120), EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to foramsulfuron residues. VIII. Other Considerations A. Endocrine Disruptors No special studies have been conducted to investigate the potential of foramsulfuron to induce estrogenic or their endocrine effects. However, no evidence of estrogenic or other endocrine effects have been noted in any of the standard toxicology studies that have been conducted with this product. Hence, there is no reason to suspect that any such effects would be likely. B. Analytical Method 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. Existing Tolerances There is an existing exemption for field corn. D. International Tolerances There are no established or proposed Codex maximum residue limits for foramsulfuron. IX. Conclusion Therefore, an exemption is established for foramsulfuron in/on corn, sweet (K+CWHR); corn, sweet, forage; corn, sweet, stover; corn, pop grain; and corn, pop, stover. X. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of 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, 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) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). 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* ., 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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not 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). 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). XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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 final rule in the **Federal Register** . This final 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: April 26, 2007. 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 180.1219 is revised to read as follows: § 180.1219 Foramsulfuron; exemption from the requirement of a tolerance. The pesticide foramsulfuron (N,N-dimethyl-2-[3-(4,6-dimethoxy-pyrimidin-2- yl)ureidosulfonyl]-4-formylaminobenzamide) is exempted from the requirement of a tolerance in corn, field, grain; corn, field, forage; corn, field, stover; corn, sweet (K+CWHR); corn, sweet, forage; corn, sweet, stover; corn, pop grain; and corn, pop, stover when applied as a herbicide in accordance with good agricultural practices. [FR Doc. E7-8901 Filed 5-8-07; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No 070322064-7097-02.; I.D. 030607E] RIN 0648-AV20 Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; 2007 Georges Bank Cod Hook Sector Operations Plan and Agreement and Allocation of Georges Bank Cod Total Allowable Catch AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: This final rule implements the Georges Bank
(GB)Cod Hook Sector Fishing Year
(FY)2007 Operations Plan and Agreement, approved by the Administrator, Northeast Region, NMFS (Regional Administrator). Amendment 13 to the Northeast
(NE)Multispecies Fishery Management Plan
(FMP)(Amendment 13) authorized allocation of up to 20 percent of the annual GB cod total allowable catch
(TAC)to the GB Cod Hook Sector (Sector). Pursuant to that authorization, the Sector submitted an Operations Plan and Sector Contract entitled, “Georges Bank Cod Hook Sector Fishing Year 2007-2008 Operations Plan and Agreement” (together referred to as the Sector Agreement) and requested an allocation of GB cod, consistent with regulations implementing Amendment 13. This action results in authorization of the Sector Operations Plan during the 2007 fishing year and allocation of 675 mt of GB cod to the Sector. DATES: Effective May 3, 2007. ADDRESSES: Copies of the Sector Agreement and the environmental assessment
(EA)are available from the NE Regional Office: Patricia A. Kurkul, Regional Administrator, NMFS, Northeast Regional Office, 1 Blackburn Drive, Gloucester, MA 01930. The Final Regulatory Flexibility Analysis
(FRFA)consists of the Initial Regulatory Flexibility Analysis (IRFA), public comments and responses, and the summary of impacts and alternatives contained in the Classification section of the preamble of this final rule. A copy of the Environmental Assessment (EA)/Regulatory Impact Review (RIR)/FRFA is accessible via the Internet at *http://www.noaa.gov/nero/regs/com.html.* Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted in writing to the address above or by e-mail to *David-Rostker@omb.eop.gov* or fax to
(202)395-7285. FOR FURTHER INFORMATION CONTACT: Thomas Warren, Fishery Policy Analyst, phone
(978)281-9347, fax
(978)281-9135, e-mail *Thomas.Warren@NOAA.gov.* SUPPLEMENTARY INFORMATION: A proposed rule that solicited public comment on the Sector Agreement was published in the **Federal Register** on April 16, 2007 (72 FR 18940), and public comments were accepted through May 1, 2007. The Regional Administrator approved the FY 2007 Sector Operations Plan, based on public comment and input from the New England Fishery Management Council (Council), and based on a determination that the Operations Plan and Agreement are consistent with the goals of the FMP and applicable law and is in compliance with the regulations governing the development and operation of a sector as specified under § 648.87. Details pertaining to the principal regulations applying to the Sector, the process of review and approval of sectors, and facts regarding the Sector's submission of the FY 2007 Sector Agreement are contained in the proposed rule. A supplemental EA entitled “Approval of the Georges Bank Cod Hook Sector Operations Plan,” which analyzes the impacts of the proposed Sector Agreement, was also prepared. The 2007 Sector Agreement and Operations Plan contains the same elements as the FY 2006 Sector Agreement. The Sector Agreement will be overseen by a Board of Directors and a Sector Manager. The Sector's GB cod TAC is based upon the number of Sector members and their qualifying historic landings of GB cod. The GB cod TAC is a “hard” TAC, meaning that, once the TAC is reached, Sector vessels may not fish under a NE Multispecies DAS, possess or land GB cod or other regulated species managed under the FMP (regulated species), or use gear capable of catching groundfish (unless fishing under charter/party or recreational regulations). Should the hard TAC be exceeded, the Sector's allocation will be reduced by the overharvest in the following year. The 2007 Operations Plan includes exemptions from the following restrictions of the FMP: The Gulf of Maine
(GOM)and GB cod trip limit; the GOM, GB, and Southern New England
(SNE)limit on the number of hooks fished; the GB Seasonal Closure Area; the DAS Leasing Program vessel size restrictions; differential DAS in the GOM Differential DAS Area and in the SNE Differential DAS Area (in those portions of the differential areas that overlap the Sector Area); and the Western U.S./Canada Area 72-hr observer program notification. In addition, the Operations Plan allows Sector members to fish in the “common pool,” subject to all of the restrictions of the FMP, prior to approval of the Operations Plan. If Sector members fish during FY 2007 under “common pool” rules, prior to fishing in the approved Sector, all cod caught will count toward the Sectors GB cod TAC. This flexibility was requested so that Sector members would be able to fish immediately at the beginning of the fishing year, and not be required to wait until approval of the Operations Plan. Justification for the other exemptions and analysis of the potential impacts of the Operations Plan are contained in the EA. A total of 25 Sector members signed the FY 2007 Sector Contract and will participate in the Sector. The proposed rule indicated that 35 Sector members and a GB cod TAC of 798 mt were expected (9.48 percent of the TAC); however, after the Operations Plan was submitted to NMFS, 10 individuals decided not to join the Sector. The GB cod TAC calculation is based upon the qualifying historic cod landings of the participating Sector vessels, regardless of gear used. The allocation percentage is calculated by dividing the sum of total landings of GB cod landed by Sector members in FY 1996 through 2001, by the sum of the total accumulated landings of GB cod landed by all NE multispecies vessels for the same time period (9,084,963 lb (4,121 mt)/113,278,842 lb (51,382.42 mt)). Based upon the qualifying landings history of the 25 Sector members, the Sector TAC of GB cod is 675 mt (8.02 percent times the fishery-wide GB cod target TAC of 8,416 mt). The fishery-wide GB cod target TAC of 8,416 mt is less than the total GB cod target TAC proposed for FY 2007 (9,822 mt) because the 9,822 mt includes Canadian catch. The Sector Agreement contains procedures for the enforcement of the Sector rules, a schedule of penalties, and provides the authority to the Sector Manager to issue stop fishing orders to members of the Sector. Participating vessels are required to land fish only in designated landing ports and are required to provide the Sector Manager with a copy of the Vessel Trip Report
(VTR)within 48 hr of offloading. Dealers purchasing fish from participating vessels are required to provide the Sector Manager with a copy of the dealer report on a weekly basis. On a monthly basis, the Sector Manager must transmit to NMFS a copy of the VTRs and the aggregate catch information from these reports. After 90 percent of the Sector's allocation has been harvested, the Sector Manager is required to provide NMFS with aggregate reports on a weekly basis. A total of 1/12 of the Sector's GB cod TAC, minus a reserve, will be allocated to each month of the fishing year. GB cod quota that is not landed during a given month will be rolled over into the following month. Once the aggregate monthly quota of GB cod is reached, for the remainder of the month, participating vessels may not fish under a NE multispecies DAS, possess or land GB cod or other regulated species, or use gear capable of catching regulated NE multispecies. Once the annual TAC of GB cod is reached, Sector members may not fish under a NE multispecies DAS, possess or land GB cod or other regulated species, or use gear capable of catching regulated NE multispecies for the rest of the fishing year. The harvest rules do not preclude vessels from fishing under the charter/party or recreational regulations, provided the vessel fishes under the applicable charter/party and recreational rules on separate trips. For each fishing trip, participating vessels are be required to fish under the NE multispecies DAS program to account for any incidental groundfish species that they may catch while fishing for GB cod. In addition, participating vessels are required to call the Sector Manager prior to leaving port. All legal-sized cod caught must be retained and landed and count against the Sector's aggregate allocation. Participating vessels are not allowed to fish with or have on board gear other than jigs, non-automated demersal longline, or handgear. NE multispecies DAS used by participating vessels while conducting fishery research under an Exempted Fishing Permit during FY 2007 will be deducted from that Sector member's individual DAS allocation. Similarly, all GB cod landed by a participating vessel while conducting research will count toward the Sector's allocation of GB cod TAC. Participating vessels will be exempt from the GB Seasonal Closure Area during May. A Letter of Authorization will be issued to each member of the Sector exempting them, conditional upon their compliance with the Sector Agreement, from the GOM and GB cod possession restrictions; the GB Seasonal Closure Area; the Western U.S./Canada Area 72-hr observer notification requirement; the DAS Leasing Program vessel size restrictions; differential DAS; the limits on the number of hooks requirements; and the prohibition on fishing as a Sector vessel and “common-pool” vessel during the same fishing year, as specified in §§ 648.86(b)(2), 648.81(g), 648.85(a)(3)(ii)(C), 648.82(k)(4)(ix), 648.82 (e)(2), 648.80(a)(4)(v), and 648.87(b)(1)(xii), respectively. Comments and Responses One comment on the Operations Plan was received. *Comment:* The commenter did not support the allowance of any exemptions in order to conserve the fish stocks. *Response:* The EA concludes that the approval of the Operations Plan would result in positive environmental impacts. The authorized exemptions are contingent upon compliance with the Operations Plan, including the GB cod hard TAC. NMFS's approval of the exemptions is consistent with the FMP and the Magnuson-Stevens Fishery Conservation and Management Act. This will not have a negative impact on fish stocks. Classification NMFS has determined that this final rule is consistent with the FMP, the Magnuson-Stevens Act, and other applicable laws. This final rule has been determined to be not significant for the purposes of Executive Order (E.O.) 12866. Pursuant to 5 U.S.C. 553(d)(1), the Assistant Administrator for Fisheries, NOAA,
(AA)finds justification to waive the delay in effectiveness of this action, because it provides the basis for NMFS to immediately grant the following exemptions from the regulations implementing the FMP for sector members, while the regulations shall remain applicable to non-members: 1. GOM and GB cod trip limit; 2. GB Seasonal Closure; 3. GOM, GB, and SNE limit on number of hooks fished; 4. DAS Leasing Program vessel size restriction; 5. Differential DAS (in the GOM Differential DAS Area and the SNE Differential DAS Area); and 6. The Western U.S./Canada Management Area 72-hr observer program notification. Because the Sector will be fishing under a hard TAC for GB cod, effort controls (i.e., exemptions 1-5 above) are not necessary to constrain the impact of the Sector on the GB cod stock. Should the Sector's allocated GB cod TAC be harvested, participating vessels would no longer be allowed to fish under a NE multispecies DAS, possess or land GB cod or other regulated species managed under the FMP, or use gear capable of catching groundfish (unless fishing under recreational or charter/party regulations). Sector members will be required to fish under their current NE multispecies DAS allocation to account for any other regulated NE multispecies that they may catch while fishing for GB cod and are restricted to using hook gear only. Because hook gear has nearly zero interaction with GB yellowtail flounder, Sector vessels are exempt from the requirement to call the observer program 72 hours in advance of starting a NE multispecies DAS when fishing in the Western U.S./Canada Area (number 6 above), since this requirement is primarily concerned with monitoring catch of GB yellowtail flounder. This final rule does not contain policies with federalism or “takings” implications as those terms are defined in Executive Order (E.O.) 13132 and E.O. 12630, respectively. A FRFA was prepared as required by section 603 of the Regulatory Flexibility Act (RFA). A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of the action, why it is being considered, and the legal basis for this action are contained in the preamble to the proposed rule and in the EA prepared for this action, and is not repeated here. Summary of the Issues Raised by Public Comments in Response to the IRFA. A Summary of the Assessment of the Agency of Such Issues, and a Statement of Any Changes Made From the Proposed Rule as a Result of Such Comments No public comments pertaining to the IRFA or the economic effects of this action were received, nor any changes made to the action as described by the proposed rule. Description of and Estimate of the Number of Small Entities To Which the Proposed Rule Would Apply The Small Business Administration size standard for small commercial fishing entities is $4 million in average annual receipts, and the size standard for small charter/party operators is $6.5 million in average annual receipts. While an entity may own multiple vessels, available data make it difficult to determine which vessels may be controlled by a single entity. For this reason, each vessel is treated as a single entity for purposes of size determination and impact assessment. All permitted and participating vessels in the groundfish fishery, including prospective Hook Gear Sector members, are considered to be small entities according to this standard and, therefore, there is no differential impact between large and small entities. The number of participants in the Sector is 25, substantially less than the total number of active vessels in the groundfish fishery. Only these 25 vessels would be subject to the regulatory exemptions and operational restrictions proposed for the Sector for FY 2007. Description of Steps the Agency Has Taken To Minimize the Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes Approval of the FY 2007 Sector Operations Plan results in an allocation of 675 mt of GB cod to the GB Cod Hook Sector, and the minimization of economic impacts on the Sector. Once the GB cod TAC is harvested, participating vessels are not be allowed to fish under a NE Multispecies DAS, possess or land GB cod, or other regulated species managed under the FMP, or use gear capable of catching groundfish (unless fishing under recreational or party/charter regulations). Vessels intending to fish in the Sector during FY 2007 may fish prior to approval of the Sector Operations Plan, provided they comply with all requirements of the FMP, and report any cod caught to the Sector Manager. Sector vessels may only fish with jigs, non-automated demersel longline, or handgear. Under the Operations Plan, members are exempt from several restrictions of the FMP described in the preamble of the proposed rule, this final rule, and in the EA. The reasons for approving the 2007 Sector Operations as proposed are as follows: Operation of the Sector would positively impact the members of the Sector (25 vessels or less) that have voluntarily joined the Sector, who are relatively dependent upon groundfish revenue compared to other participants in the groundfish fishery. Sector operations will indirectly benefit the communities of Chatham and Harwichport, MA, and to a lesser extent, other Cape Cod communities involved in the groundfish fishery. During FY 2005, members of the Sector landed 275,743 lb (125,054 kg) of cod and 1,114,401 lb (505,397 kg) of haddock, generating approximately $402,000, and $1,314,000 in revenue, respectively (assuming a dock-side price of $1.46 and $1.18 per lb, respectively). Sector members also landed various other species, which contributed slightly more to their revenue. In general, the operation of the Sector will continue to mitigate the negative economic impacts that result from the current suite of regulations that apply to the groundfish fishery (most recently, Framework Adjustment 42; 71 FR 62156; October 23, 2006). The Sector, by fishing under rules that are designed to meet their needs (as well as the conservation requirements of the FMP), is afforded a larger degree of flexibility and efficiency, which is expected to result in economic gains. For example, Sector members are able to plan their fishing activity and income in advance with more certainty due to the fact that there is a cod TAC, which is apportioned to each month of the year. They are also able to maximize their efficiency (revenue per trip) due to the Sector's exemption from trip limits and hook numbers. For some vessel owners in the Sector, participation in the Sector enables their businesses to remain economically viable. For the above reasons, approval of the 2007 Sector Operations minimizes the impact on small entities. In contrast, under the No Action alternative, all Sector members would have remained in the common pool of vessels and fished under all the rules implemented by Amendment 13 and subsequent Framework Adjustments. Under the regulatory scenario of the No Action alternative, relative to the preferred alternative, Sector members would likely have faced increased economic uncertainty, loss of efficiency, and loss of revenue. Because cod usually represents a high proportion of total fishing income for hook gear vessels, revenues for Sector members are sensitive to regulations that impact how and when they can fish for cod, such as trip limits and hook gear restrictions. Sector members would have beeen unnecessarily impacted by regulations designed to affect the catch of species of which hook gear catches very little (e.g., yellowtail flounder, because hook gear is more selective than other gear types). For example, under the No Action alternative, Sector members would have been affected by the differential DAS counting requirement, one of the objectives of which is to protect yellowtail flounder. Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Action This final rule contains a collection-of-information requirement subject to the Paperwork Reduction Act
(PRA)and which has been approved by the Office of Management and Budget
(OMB)under control number 0648-0202. Public reporting burden for the Submission of a Plan of Operation for an Approved Sector Allocation is estimated to average 50 hr per response, and for the Annual Reporting Requirements for Sectors is estimated to average 6 hr per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES ) and by e-mail to *David_Rostker@omb.eop.gov,* or fax to
(202)395-7285. Nothwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number. Authority: 16 U.S.C. 1801 *et seq.* Dated: May 3, 2007. William T. Hogarth, Assistant Administrator for Fisheries, National Marine Fisheries Service. [FR Doc. 07-2281 Filed 5-3-07; 5:04 pm]
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  • 21 CFR 510
  • 5 USC 801-808
  • 21 CFR 529
  • 21 CFR 20
  • 21 CFR 866
  • 21 CFR 807
  • 5 USC 601-612
  • Pub. L. 104-4
  • 30 CFR 935
  • 33 CFR 165
  • Pub. L. 104-121
  • 44 USC 3501-3520
  • 2 USC 1531-1538
  • 42 USC 4321-4370f
  • Pub. L. 107-295
  • 40 CFR 174
  • 40 CFR 178
  • 40 CFR 2
  • 40 CFR 174.452
  • 40 CFR 158.740(b)(2)(i)
  • 40 CFR 174.475
  • Pub. L. 104-113
  • 7 USC 136-136y
  • 40 CFR 180
  • 40 CFR 180.527
  • 40 CFR 180.458
  • 40 CFR 166
  • 40 CFR 180.566
  • 40 CFR 180.1219
  • 50 CFR 648
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C.F.R.§ 514.11
C.F.R.§ 25.33
U.S.C.§ 360b
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