Fed. Reg. Proposed Rules — Final rule

BILLING CODE 4830-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2008-0031] RIN 1625-AA08 Regattas and Marine Parades; Great Lake Annual Marine Events AGENCY: Coast Guard, DHS. ACTION: Final rule. SUMMARY: The Coast Guard is amending special local regulations for annual regattas and marine parades in the Captain of the Port Lake Michigan zone. This rule will place restrictions on vessel movement in portions of the Calumet Sag Channel and the Little Calumet River during the annual Southland Regatta.

The Southland Regatta is a university rowing race that will be held annually during the first weekend of November. This rule is intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after regattas or marine parades. DATES: This rule is effective August 8, 2008. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket USCG-2008-0031 and are available online at *http:www.regulations.gov.* This material is also available for inspection or copying at two locations: the Docket Management Facility (M-30), U.S.

Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays and the U.S. Coast Guard Sector Lake Michigan, 2420 South Lincoln Memorial Drive, Milwaukee, WI 53207, between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call Lieutenant Commander Kimber Bannan, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI, 414-747-7159.

If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-493-0402. SUPPLEMENTARY INFORMATION: Regulatory Information On February 6, 2008, we published a notice of proposed rulemaking

(NPRM)entitled Regattas and Marine Parades; Great Lake Annual Marine Events in the **Federal Register** (73 FR 6859). We received one letter commenting on the proposed rule. No public meeting was requested, and none was held. Background and Purpose This rule will add a subpart to 33 CFR Part 100 that will place restrictions on the portions of the Calumet Sag Channel and the Little Calumet River during the annual Southland Regatta. The Southland Regatta is a university rowing race that will be held annually during the first weekend of November. Discussion of Comments and Changes One comment was received regarding this rule. The comment endorsed the rule stating that it would enable the Southland Regatta contestants to focus on the competition without the threat of danger, collision, and injury from vessels and recreational boaters on the water before, during, and after the event. 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 this rule under that Order. The Coast Guard's use of these special local regulations will be periodic, of short duration, and designed to minimize the impact on navigable waters. These special local regulations will only be enforced immediately before, during, and immediately after the time the marine events occur. Furthermore, these special local regulations have been designed to allow vessels to transit unrestricted to portions of the waterways not affected by the special local regulations. The Coast Guard expects insignificant adverse impact to mariners from the activation of these special local regulations. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners of operators of vessels intending to transit or anchor in the Calumet Sag Channel and the Little Calumet River on the first weekend of November. This special local regulation will not have a significant economic impact on a substantial number of small entities for the following reasons: The rule will be in effect for short periods of time and only once per year, is designed to allow traffic to pass safely around the zone whenever possible; and allows vessels to pass through the zone with the permission of the Captain of the Port. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM 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. 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). 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. 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 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 The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that these regulations and fishing rights protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes that have questions concerning the provisions of this Rule or options for compliance are encouraged to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT . 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)(h), of the Instruction, from further environmental documentation. A final environmental analysis check list and a final categorical exclusion determination are available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. Add § 100.910 to read as follows: § 100.910 Southland Regatta; Blue Island, IL.

(a)*Regulated Area.* A regulated area is established to include all waters of the Calumet Sag Channel from the South Halstead Street Bridge at 41°39′27″ N, 087°38′29″ W; to the Crawford Avenue Bridge at 41°39′05″ N, 087°43′08″ W; and the Little Calumet River from the Ashland Avenue Bridge at 41°39′07″ N, 087°39′38″ W; to the junction of the Calumet Sag Channel. (DATUM: NAD 83).

(b)*Special Local Regulations.* The regulations of § 100.901 apply. No vessel may enter, transit through, or anchor within the regulated area without the permission of the Coast Guard Patrol Commander.

(c)*Enforcement Period.* This section will be enforced annually on the Saturday immediately prior to the first Sunday of November, from 3 p.m. until 5 p.m. and the first Sunday of November, from 9 a.m. until 5 p.m. Dated: June 12, 2008. Peter V. Neffenger, Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District. [FR Doc. E8-15490 Filed 7-8-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2008-0610] Special Local Regulations for Marine Events; Port Huron to Mackinac Island Race AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce the special local regulation for the Port Huron to Mackinac Island Race, July 12, 2008, at 11 a.m. to July 15, 2008, at 11:59 p.m. This action is necessary to safely control vessel movements in the vicinity of the race and provide for the safety of the general boating public and commercial shipping. During this period, no person or vessel may enter the regulated area without the permission of the Coast Guard Patrol Commander. DATES: This rule is effective from July 12, 2008, at 11 a.m. through July 15, 2008, at 11:59 p.m. FOR FURTHER INFORMATION CONTACT: Mr. Frank Jennings, Jr., Enforcement Branch, Ninth Coast Guard District, 1240 East 9th Street, Cleveland, OH at

(216)902-6095. SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special local regulation for the annual Port Huron to Mackinac Race July 12, 2008 at 11 a.m. through July 15, 2008 at 11:59 p.m. The Special Local Regulations apply to the waters of the Black River, St. Clair River and lower Lake Huron from: *Latitude* *Longitude* 42[deg]58.8[min] N 082[deg]26[min] W, to 42[deg]58.4[min] N 082[deg]24.8[min] W, thence northward along the International Boundary to 43[deg]02.8[min] N 082[deg]23.8[min] W, to 43[deg]02.8[min] N 082[deg]26.8[min] W, thence southward along the U.S. shoreline to 42[deg]58.9[min] N 082[deg]26[min] W, thence to 42[deg]58.8[min] N 082[deg] 26[min] W. In order to ensure the safety of spectators and participating vessels, the special local regulation will be in effect for the duration of the event. The Coast Guard will patrol the race area under the direction of a designated Coast Guard Patrol Commander. Vessels desiring to transit the regulated area may do so only with prior approval of the Coast Guard Patrol Commander (PATCOM) and when so directed by that officer. The PATCOM may be contacted on Channel 16 (156.8 MHZ) by the call sign “Coast Guard Patrol Commander.” Vessels will be operated at a no wake speed to reduce the wake to a minimum, and in a manner which will not endanger participants in the event or any other craft. The rules contained in the above two sentences shall not apply to participants in the event or vessels of the patrol operating in the performance of their assigned duties. In the event this special local regulation affects shipping, commercial vessels may request permission from the PATCOM to transit the area of the event by hailing call sign “Coast Guard Patrol Commander” on Channel 16 (156.8 MHZ). This notice is issued under the authority of 33 CFR Part 100.901 and 5 U.S.C. 552(a). If the District Commander, Captain of the Port or PATCOM determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area. Dated: June 24, 2008. David R. Callahan, Captain, U.S. Coast Guard, Acting Commander, Ninth Coast Guard District. [FR Doc. E8-15491 Filed 7-8-08; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 50, 51, 53 and 58 [EPA-HQ-OAR-2006-0735; FRL-8689-2] RIN 2060-AN83 National Ambient Air Quality Standards for Lead AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of extension of comment period. SUMMARY: The EPA is announcing an extension of the public comment period on the proposed rule “National Ambient Air Quality Standards for Lead.” As initially published in the **Federal Register** on May 20, 2008, written comments on the proposed rule were to be submitted by July 21, 2008. On July 1, 2008, EPA received a court order extending the deadline for signature of the notice of final rulemaking to October 15, 2008 and extending the public comment period on the proposed rule to August 4, 2008. DATES: Comments must be received by August 4, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2006-0735 by one of the following methods: • *www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: a-and-r-Docket@epa.gov.* • *Fax:* 202-566-9744. • *Mail:* Docket No. EPA-HQ-OAR-2006-0735, Environmental Protection Agency, Mail code 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please include a total of two copies. • *Hand Delivery:* Docket No. EPA-HQ-OAR-2006-0735, Environmental Protection Agency, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-HQ-OAR-2006-0735. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket, visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the Air and Radiation Docket and Information Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is

(202)566-1744 and the telephone number for the Air and Radiation Docket and Information Center is

(202)566-1742. FOR FURTHER INFORMATION CONTACT: For further information, contact Dr. Deirdre Murphy, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail code C504-06, Research Triangle Park, NC 27711; telephone: 919-541-0729; fax: 919-541-0237; e-mail: *Murphy.deirdre@epa.gov.* SUPPLEMENTARY INFORMATION: General Information Extension of Public Comment Period The notice of proposed rulemaking was signed by the Administrator on May 1, 2008 and published in the **Federal Register** on May 20, 2008 (73 FR 29184). The schedule for completion of this review is governed by a judicial order in *Missouri Coalition for the Environment* v. *EPA* (No. 4:04CV00660 ERW, Sept.14, 2005). In light of the numerous complex issues discussed in the notice of proposed rulemaking, EPA and the Missouri Coalition for the Environment jointly sought an amendment of the judicial order to extend the comment period on the notice of proposed rulemaking to August 4, 2008 and to extend the deadline for signature of the notice of final rulemaking to October 15, 2008. On July 1, 2008, the court granted the joint motion, and therefore EPA is extending the comment period until August 4, 2008. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI.* Do not submit this information to EPA through www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for Preparing Your Comments.* When submitting comments, remember to: • Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). • Follow directions—the agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. • Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. Availability of Related Information A number of documents relevant to this rulemaking, including the notice of proposed rulemaking (73 FR 29184), the advance notice of proposed rulemaking (72 FR 71488), the *Air Quality Criteria for Lead* (Criteria Document) (USEPA, 2006a), the Staff Paper, related risk assessment reports, and other related technical documents are available on EPA(s Office of Air Quality Planning and Standards (OAQPS) Technology Transfer Network

(TTN)Web site at * http://www.epa.gov/ttn/naaqs/ standards/pb/s_pb_index.html * . These and other related documents are also available for inspection and copying in the EPA docket identified above. Dated: July 3, 2008. Mary Henigen, Acting Director, Office of Air Quality Planning and Standards. [FR Doc. E8-15579 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2006-0186, FRL-8569-6] Revisions to the California State Implementation Plan, Northern Sierra Air Quality Management District, Including Nevada County Air Pollution Control District Portion, Plumas County Air Pollution Control District Portion, and Sierra County Air Pollution Control District Portion AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action to approve revisions to the Northern Sierra Air Quality Management District (NSAQMD) portion of the California State Implementation Plan

(SIP)portion of the SIP, including the Nevada County Air Pollution Control District (NCAPCD), Plumas County Air Pollution Control district (PCAPCD), and Sierra County Air Pollution Control District (SCAPCD) portions of the SIP. These revisions concern the permitting of air pollution sources. We are approving local and removing local rules under authority of the Clean Air Act as amended in 1990 (CAA or the Act). DATES: This rule is effective on September 8, 2008, without further notice, unless EPA receives adverse comments by August 8, 2008. If we receive such comments, we will publish a timely withdrawal in the **Federal Register** to notify the public that this rule will not take effect. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2006-0186, by one of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the on-line instructions. • *E-mail: R9airpermits@epa.gov.* • *Mail or deliver:* Gerardo Rios (Air-3), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105. *Instructions:* All comments will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through *http://www.regulations.gov* or e-mail. *http://www.regulations.gov* is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at *http://www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section below. FOR FURTHER INFORMATION CONTACT: Laura Yannayon, Permits Office (AIR-3), U.S. Environmental Protection Agency, Region IX,

(415)972-3534, *yannayon.laura@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document, “we,” “us” and “our” refer to EPA. Table of Contents I. The State's Submittal A. What rules did the State submit? B. Are there other versions of these rules? C. What rules are being removed from the SIP by EPA? D. What are the purposes of the rule revisions or rule removals? II. EPA's Evaluation and Action A. How is EPA evaluating the rules? B. Do the rule submittals meet the evaluation criteria? C. Public comment and final action III. Statutory and Executive Order Reviews I. The State's Submittal A. What Rules Did the State Submit? Table 1 lists the rules we are approving with the date of adoption by the local air agency and submittal by the California Air Resources Board (CARB). Table 1.—Rules Submitted by the NSAQMD Local agency Rule No. Rule title Adopted or amended Submitted NSAQMD 501 Permit Required 05/11/94, Amended 10/28/96 NSAQMD 505 Conditional Approval 09/11/91, Adopted 10/28/96 NSAQMD 510 Separation of Emissions 09/11/91, Adopted 10/28/96 NSAQMD 511 Combination of Emissions 09/11/91, Adopted 10/28/96 NSAQMD 512 Circumvention 09/11/91, Adopted 10/28/96 NSAQMD 513 Source Recordkeeping 05/11/94, Amended 10/28/96 NSAQMD 515 Provision of Sampling and Testing Facilities 09/11/91, Adopted 10/28/96 NSAQMD 517 Transfer 09/11/91, Adopted 10/28/96 On December 19, 1996, the submittal of the rules in table 1 was found to meet the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review. B. Are There Other Versions of These Rules? There are certain versions of SIP rules from the three individual defunct county air districts, NCAPCD, PCAPCD, and SCAPCD, being superseded by the submitted NSAQMD rules below: NSAQMD Rule 501, Permit Required, supersedes the following versions: • PCAPCD Rule 501, Permit Required (submitted on June 22, 1981, approved on June 18, 1982). • SCAPCD Rule 501, Permit Required (submitted on June 22, 1981, approved on June 18, 1982). NSAQMD Rule 505, Conditional Approval, supersedes the following versions: • NCAPCD Section 16, Conditional Approval (submitted on February 21, 1972, approved on May 31, 1972). • PCAPCD Rule 505, Conditional Approval (submitted on June 22, 1981, approved on June 18, 1982). • SCAPCD Rule 505, Conditional Approval (submitted on June 22, 1981, approved on June 18, 1982). NSAQMD Rule 515, Provision of Sampling and Testing Facilities, supersedes the following versions: • SCAPCD Section 47, Emission Monitoring (submitted on February 21, 1972, approved on May 31, 1972). • SCAPCD Section 49, Tests (submitted on February 21, 1972, approved on May 31, 1972). • SCAPCD Section 50, Field Inspection (submitted on February 21, 1972, approved on May 31, 1972). NSAQMD Rule 517, Transfer, supersedes the following versions: • PCAPCD Rule 517, Transfer (submitted on June 22, 1981, approved on June 18, 1982). • SCAPCD Rule 517, Transfer (submitted on June 22, 1981, approved on June 18, 1982). There are no versions of submitted NSAQMD Rules 510, 511, 512, and 513 in the SIP. C. What Rules Are Being Removed From the SIP by EPA? Rules of the individual defunct air districts that we are removing from the SIP are listed in tables 2, 3, and 4. The original dates of submittal by the California Air Resources Board

(CARB)and approval by EPA, along with the reason for removal from the SIP, are provided. Table 2.—Rules Removed From the NCAPCD SIP by EPA Local agency Rule or section Rule title Submitted Approved by EPA Reason for removal NCAPCD 11 Registration Required 02/21/72 05/31/72 ( 1 ) NCAPCD 51 Nuisance 02/21/72 05/31/72 ( 1 ) NCAPCD 106 Validity 04/10/75 06/14/78 ( 1 ) NCAPCD 107 Effective Date 04/10/75 06/14/78 ( 1 ) NCAPCD 201 District-Wide Coverage 04/10/75 06/14/78 ( 1 ) NCAPCD 215 Existing Sources 04/10/75 06/14/78 ( 1 ) NCAPCD 401 Responsibility 04/10/75 06/14/78 ( 1 ) NCAPCD 403 Responsibility of Permitting 04/10/75 06/14/78 ( 1 ) Table 3.—Rules Removed From the PCAPCD SIP by EPA Local agency Rule or section Rule title Submitted Approved by EPA Reason for removal PCAPCD 507 Responsibility 06/22/81 06/18/82 ( 1 ) PCAPCD 508 Posting of Permit to Operate 06/22/81 06/18/82 ( 3 ) Table 4.—Rules Removed From the SCAPCD SIP by EPA Local agency Rule or section Rule title Submitted Approved by EPA Reason for removal SCAPCD 201 District-Wide Coverage 01/10/75 08/22/77 ( 1 ) SCAPCD 205 Nuisance 01/10/75 08/22/77 ( 2 ) SCAPCD 507 Responsibility 06/22/81 06/18/82 ( 1 ) SCAPCD 508 Posting of Permit to Operate 06/22/81 06/18/82 ( 1 ) Notes: Reasons for removal from the SIP of the rules in tables 2, 3, and 4 are as follows: 1 The rule is not required for the SIP to achieve or maintain attainment. 2 The rule is not appropriate for EPA to enforce. 3 The rule is appropriate to be in the SIP, but is not approvable according to current EPA requirements. D. What Are the Purposes of the Rule Revisions or Rule Removals? Section 110(a) of the CAA requires states to submit regulations that control volatile organic compounds, nitrogen oxides, particulate matter, and other air pollutants which harm human health and the environment. Permitting rules were developed as part of the local air district's programs to control these pollutants. The overall purpose of the present actions on NSAQMD permitting rules is to partially consolidate the SIP rules from the original individual air districts, NCAPCD, PCAPCD, and SCAPCD, into one set of SIP rules for the unified NSAQMD. The SIP rules being removed are from three defunct individual county air districts, NCAPCD, PCAPCD, and SCAPCD, which were unified to form the NSAQMD. These defunct district rules are not appropriate or required for the SIP or were replaced by currently-active NSAQMD SIP rules. The rules listed in tables 2, 3, and 4 are being removed from the SIP by EPA under the authority of section 110(k)(6) of the CAA. The removal of these listed rules does not relax the SIP and does not result in an increase in air emissions. The purposes of the new submitted rules are as follows: • *Rule 510:* The rule clarifies that the emissions from multiple emission points in a single source operation may not exceed the limit that would have applied for one emission point for that source. • *Rule 511:* The rule allows multiple emission sources to be regulated separately if the emissions are combined and if the emissions are susceptible to reliably attributing the amount of emissions to each individual source. Otherwise, combined multiple emission sources must be regulated with the most stringent regulation for a single emission source. • *Rule 512:* The rule prohibits circumvention of regulations by superficially reducing or concealing emissions that might violate emission regulations. • *Rule 513:* The rule requires recordkeeping and reporting with a two-year retention period of those emissions required by the APCO. The purposes of revisions relative to the SIP rules are as follows: • *Rule 501:* The requirement that major sources subject to title V comply with federal operating permit regulations is added. • *Rule 505:* The authority of the Air Pollution Control Officer

(APCO)to grant a permit to rent or sell air pollution control equipment is removed. • *Rule 515:* The requirements for sampling and testing to determine compliance with emission regulations are unified from the defunct district rules. • *Rule 517:* The requirements for the transfer of ownership of an emission source are unified from the defunct district rules. II. EPA's Evaluation and Action A. How Is EPA Evaluating the Rules? Generally, SIP rules regulating permitting must be enforceable (see section 110(a) of the CAA) and must not relax existing requirements (see sections 110(l) and 193). The revision or removal of SIP rules must not relax existing requirements. The NSAQMD regulates an 8-hour CAA subpart 1 ozone nonattainment area. There are no specific RACT requirements for permitting rules. The following guidance documents were used for reference: • *Requirements for Preparation, Adoption, and Submittal of Implementation Plans* , EPA, 40 CFR part 51. • *Guidance Document for Correcting Common VOC & Other Rule Deficiencies* , EPA Region IX (August 21, 2001). (The Little Bluebook) B. Do the Rule Submittals and Rule Removals Meet the Evaluation Criteria? We believe the rule approvals and rule removals are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSD has more information on our evaluation. C. Public Comment and Final Action EPA is approving local NSAQMD Rules 501, 505, 510, 511, 512, 513, 515, and 517 into the SIP and approving the removal of eight NCAPCD, two PCAPCD, and four SCAPCD permitting rules from the SIP. We believe these actions fulfill all relevant requirements. We do not think anyone will object to this, so we are finalizing the approvals and removals without proposing them in advance. However, in the Proposed Rules section of this **Federal Register** , we are simultaneously proposing approval of the same actions. If we receive adverse comments by August 8, 2008, we will publish a timely withdrawal in the **Federal Register** to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on September 8, 2008. This will incorporate the submitted rules in table 1 into the federally-enforceable SIP and remove the rules in tables 2, 3, and 4 from the SIP. Superseded SIP rules for those rules in table 1 are also removed from the SIP. There are no sanctions or FIP clocks associated with any previous action on the rules. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. III. Statutory and Executive Order Reviews Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action: • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993); • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq.* ); • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ); • Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action 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 the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 8, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: April 16, 2008. Laura Yoshii, Acting Regional Administrator, Region IX. Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart F—California 2. Section 52.220 is amended by adding paragraphs (b)(7)(iii), (c)(26)(ix)(D), (c)(27)(vii)(F), (c)(93)(iii)(E), (c)(93)(iv)(F), (c)(246)(i)(A)( *4* ) and ( *5* ) to read as follows: § 52.220 Identification of plan.

(b)* * *

(7)* * *

(iii)Previously approved on May 31, 1972 in paragraph

(b)of this section and now deleted without replacement Rules 11 and 51.

(c)* * *

(26)* * *

(ix)* * *

(D)Previously approved on August 22, 1977 in paragraph (c)(26)(ix)(A) of this section and now deleted without replacement Rules 201 and 205.

(27)* * *

(vii)* * *

(F)Previously approved on June 14, 1978 in paragraph (c)(27)(vii)(A) of this section and now deleted without replacement Rules 106, 107, 201, 215, 401, and 403.

(93)* * *

(iii)* * *

(E)Previously approved on June 18, 1982 in paragraph (c)(93)(iii)(B) of this section and now deleted without replacement Rules 507 and 508.

(iv)* * *

(F)Previously approved on June 18, 1982 in paragraph (c)(93)(iv)(B) of this section and now deleted without replacement Rules 507 and 508.

(246)* * *

(i)* * *

(A)* * * ( *4* ) Rule 505, “Conditional Approval,” Rule 510, “Separation of Emissions,” Rule 511, “Combination of Emissions,” Rule 512, “Circumvention,” Rule 515, “Provision of Sampling and Testing Facilities,” and Rule 517, “Transfer,” adopted on September 11, 1991. ( *5* ) Rule 501, “Permit Required” and Rule 513, “Source Recordkeeping,” amended on May 11, 1994. [FR Doc. E8-15435 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0416; FRL-8371-9] Azoxystrobin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on animal feed, nongrass, forage, group 18 at 45 parts per million (ppm); animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at 25 ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at 0.6 ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at 5.0 ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum, stover at 40 ppm; and wheat, forage at 25 ppm. Syngenta Crop Protection, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). EPA is also deleting certain azoxystrobin tolerances that are no longer needed as a result of this action. DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0416. To access the electronic docket, go to *http://www.regulations.gov* , and search for the docket number. 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: John Bazuin, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-7381; e-mail address: *bazuin.john@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). • 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 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 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-2007-0416 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 September 8, 2008. 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-2007-0416, 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. Petition for Tolerance In the **Federal Register** of September 28, 2007 (72 FR 55204) (FRL-8147-1), 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 6F7106 and 7F7198) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27409. Petition PP 6F7106 requested that 40 CFR 180.507(a)(1) be amended by establishing tolerances for combined residues of the fungicide azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate in or on barley, forage at 30 ppm; non-grass animal feeds, forage at 35 ppm; non-grass animal feeds, hay at 100 ppm; sorghum, forage at 25 ppm; sorghum, grain at 9 ppm; sorghum, stover at 40 ppm; and wheat, forage at 30 ppm. Petition PP 6F7106 also requested that 40 CFR 180.507(a)(2) be amended by establishing tolerances for residues of the fungicide azoxystrobin in or on cattle, kidney at 1.00 ppm; cattle, liver at 5.10 ppm; cattle, meat byproducts (except liver and kidney) at 0.07 ppm; goat, kidney at 1.00 ppm; goat, liver at 5.10 ppm; goat, meat byproducts (except liver and kidney) at 0.07 ppm; egg, white at 0.01 ppm; egg, yolk at 0.15 ppm; hog, kidney at 0.03 ppm; hog, liver at 0.23 ppm; hog, meat byproducts (except liver and kidney) at 0.01 ppm; horse, kidney at 1.00 ppm; horse, liver at 5.10 ppm; poultry, fat at 0.01 ppm; poultry, liver at 0.12 ppm; poultry, meat at 0.02 ppm; sheep, kidney at 1.00 ppm; sheep, liver at 5.10 ppm; sheep, meat byproducts (except liver and kidney) at 0.07 ppm. Petition PP 6F7106 additionally requested that 40 CFR 180.507(a)(1) be amended by increasing the tolerance for the combined residues of the fungicide azoxystrobin and the Z isomer of azoxystrobin in or on aspirated grain fractions to 112 ppm; increasing the tolerances for the residues of the fungicide azoxystrobin in or on cattle, fat to 0.13 ppm; cattle, meat to 0.07 ppm; goat, fat to 0.13 ppm; goat, meat to 0.07 ppm; hog, fat to 1.10 ppm; horse, meat to 0.07 ppm; milk to 0.05 ppm; sheep, fat to 0.13 ppm; and sheep, meat to 0.07 ppm; and leaving the tolerance for the residues of the fungicide azoxystrobin and the Z isomer of azoxystrobin in or on hog, meat unchanged at 0.01 ppm. Petition PP 7F7198 requested that 40 CFR 180.507(a)(1) be amended by establishing a permanent tolerance for combined residues of the fungicide azoxystrobin and the Z isomer of azoxystrobin in or on rice, wild at 5.0 ppm and by changing the tolerances for combined residues of the fungicide azoxystrobin and the Z isomer of azoxystrobin in or on cotton, gin byproducts to 35 ppm and cotton, undelinted seed to 0.7 ppm. That notice referenced a summary of the petition prepared by Syngenta Crop Protection, Inc., 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 is not modifying the tolerances for ruminant and swine raw agricultural commodities

(RACs)or establishing tolerances for poultry RACs. EPA is, however, increasing the proposed tolerance for sorghum grain from 9 ppm to 11 ppm, increasing the proposed tolerance for aspirated grain fractions from 112 ppm to 420 ppm, reducing the proposed tolerances of 30 ppm for both wheat forage and barley forage to 25 ppm, reducing the proposed tolerance for undelinted cotton seed from 0.7 to 0.6 ppm, increasing the proposed tolerance for cotton gin byproducts from 35 to 45 ppm, increasing the proposed tolerance for non-grass animal feeds, forage from 35 to 45 ppm, and increasing the proposed tolerance for non-grass animal feeds, hay from 100 to 120 ppm. EPA is also revoking the two expired time-limited tolerances for safflower, seed at 1.0 ppm; and for Brassica, head and stem, subgroup 5A of 30 ppm in 40 CFR 180.507(b). The rice, wild tolerance in 40 CFR 180.507(b) is also being revoked. The reasons for these changes are explained in Unit IV.C. III. Aggregate Risk Assessment and Determination of Safety 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. . . .” Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for combined residues of azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on animal feed, nongrass, forage, group 18 at 45 ppm; animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at 25 ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at 0.6 ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at 5.0 ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum, stover at 40 ppm; and wheat, forage at 25 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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 Azoxystrobin has low acute toxicity via the oral, dermal and inhalation routes of exposure. Azoxystrobin is not an eye or skin irritant and is not a skin sensitizer. The most common toxicity findings from administration of azoxystrobin to rats, via the oral route, were decreased body weight, decreased food intake/utilization, increased diarrhea, and other clinical toxicity observations such as, increased urinary incontinence, hunched postures and distended abdomens. There were no developmental effects in the rat and rabbit developmental studies. In the reproduction study, decreased body weights and increased adjusted liver weights were observed at the same dose in both offspring and parental animals. In both the acute and subchronic neurotoxicity studies, there were no consistent indications of treatment-related neurotoxicity. There was no evidence of carcinogenicity in rats and mice at acceptable dose levels. Azoxystrobin induced a weak mutagenic response in the mouse lymphoma assay, but the activity expressed in vitro is not expected to be expressed in whole animals. Specific information on the studies received and the nature of the adverse effects caused by azoxystrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the **Federal Register** of September 29, 2000 (65 FR 58404) (FRL-6749-1). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure

(POD)is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose

(BMD)approach is sometimes used for risk assessment. Uncertainty/safety factors

(UFs)are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure

(MOE)called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for azoxystrobin used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of September 29, 2000. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to azoxystrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing azoxystrobin tolerances in (40 CFR 180.507). EPA assessed dietary exposures from azoxystrobin 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. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA used tolerance level residues, a 100% crop treated assumption, and default processing factors for all existing and proposed uses. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA used tolerance level residues and default processing factors for all existing and proposed uses. As to percent crop treated, EPA used data on the actual percentage of crop treated for some existing uses and assumed 100% crop treated for all proposed uses, and all other existing uses. iii. *Cancer* . The Agency has determined that azoxystrobin is not likely to be a human carcinogen, so an exposure assessment to estimate cancer risk is unnecessary. iv. *Percent crop treated

(PCT)information* . EPA did not use anticipated residue information in the dietary assessment for azoxystrobin. Tolerance level residues were assumed for all food commodities. 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: • *Condition* 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 the pesticide residue. • *Condition* b: The exposure estimate does not underestimate exposure for any significant subpopulation group. • *Condition* 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 FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Acerola - 100%; almond - 20%; amaranth, leafy - 100%; apricot - 15%; arrowroot - 100%; artichoke, globe - 100%; artichoke, Jerusalem - 100%; arugula - 100%; asparagus - 1%; avocado - 100%; balsam pear - 100%; banana - 100%; barley - 100%; basil - 100%; bean, black - 1%; bean, broad - 1%; bean, cowpea - 1%; bean, great northern - 1%; bean, kidney - 1%; bean, lima - 1%; bean, mung - 1%; bean, navy - 1%; bean, pink - 1%; bean, pinto - 1%; bean, snap - 25%; beet, garden - 15%; beet, sugar - 1%; blackberry - 100%; blueberry - 15%; boysenberry - 100%; Brazil nut - 100%; broccoli - 100%; Brussels sprouts - 100%; burdock - 100%; butternut - 100%; cabbage - 5%; canistel - 100%; cantaloupe - 10%; cardoon - 100%; carrot - 10%; casaba - 100%; cashew - 100%; cassava - 100%; cattle fat, kidney, liver, meat, and meat byproducts - 100%; cauliflower - 100%; celeriac - 100%; celery - 10%; celtuce - 100%; chayote - 100%; cherimoya - 100%; cherry - 5%; chestnut - 100%; chickpea - 1%; chicory - 100%; Chinese waxgourd - 100%; chive - 100%; chrysanthemum, garland - 100%; cinnamon - 100%; citrus citron - 100%; citrus hybrids - 100%; citrus, oil - 100%; collards - 100%; coriander - 100%; corn, field - 100%; corn, pop - 100%; corn, sweet - 10%; cottonseed, oil - 1%; cranberry - 100%; cress, garden - 100%; cress, upland - 100%; cucumber - 15%; currant - 100%; dandelion, leaves - 100%; dasheen, corm - 100%; dasheen, leaves - 100%; dewberry - 100%; dill, seed - 100%; dillweed - 100%; eggplant - 100%; elderberry - 100%; endive - 100%; feijoa - 100%; fennel, Florence - 100%; filbert - 5%; flaxseed, oil - 5%; garlic - 50%; ginger - 100%; ginseng - 100%; goat fat, kidney, liver, meat, and meat byproducts - 100%; gooseberry - 100%; grape - 10%; grapefruit - 20%; guar, seed - 1%; guava - 100%; herbs, other - 100%; hickory nut - 100%; honeydew melon - 5%; hop - 100%; horse, meat - 100%; horseradish - 100%; huckleberry - 100%; jaboticaba - 100%; jackfruit - 100%; kale - 100%; kohlrabi - 100%; kumquat - 100%; leek - 100%; lemon - 100%; lemongrass - 100%; lentil, seed - 1%; lettuce, head - 1%; lettuce, leaf - 1%; lime - 100%; loganberry - 100%; longan - 100%; loquat - 100%; lychee - 100%; macadamia nut - 100%; mango - 100%; marjoram - 100%; milk - 100%; mustard greens - 15%; nectarine - 100%; okra - 100%; onion, dry bulb - 10%; onion, green - 10%; orange - 17%; papaya - 100%; parsley - 30%; parsley, turnip-rooted - 100%; passionfruit - 100%; pawpaw - 100%; pea, succulent - 1%; pea, dry - 1%; pea, edible podded - 25%; pea, pigeon - 1%; peach - 5%; peanut - 10%; pecan - 1%; pepper, bell - 10%; pepper, non-bell - 10%; peppermint - 100%; persimmon - 100%; pistachio - 30%; plantain - 100%; plum - 1%; pork fat, kidney, liver, meat, meat byproducts, and skin - 100%; potato - 25%; pummelo - 100%; pumpkin - 20%; radicchio - 100%; radish - 100%; radish, Oriental - 100%; rape greens - 100%; rapeseed, oil - 5%; raspberry - 100%; rhubarb - 100%; rice - 25%; rutabaga - 100%; safflower - 5%; salsify, roots - 100%; salsify, tops - 100%; sapote, Mamey - 100%; savory - 100%; shallot - 100%; sheep fat, kidney, liver, meat, and meat byproducts - 100%; sorghum - 100%; soursop - 100%; soybean - 1%; Spanish lime - 100%; spearmint - 100%; spices, other - 100%; spinach - 10%; squash, summer - 15%; squash, winter - 15%; starfruit - 100%; strawberry - 20%; sugar apple - 100%; sunflower - 5%; sweet potato - 100%; Swiss chard - 100%; tamarind - 100%; tangerine - 20%; tanier - 100%; tomatillo - 100%; tomato - 20%; turmeric - 100%; turnip, roots - 100%; turnip, greens - 15%; walnut - 1%; watercress - 100%; watermelon - 25%; wheat - 1%; wild rice - 100%; yam, true - 100%; and yam bean - 100%. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%. The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from 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 b and c, 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 reliable information on the regional consumption of food to which azoxystrobin may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for azoxystrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of azoxystrobin. 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* . Based on the First Index Reservoir Screening Tool (FIRST) model for surface water and the Screening Concentration in Ground Water (SCI-GROW) model for ground water, the estimated drinking water concentrations (EDWCs) of azoxystrobin for acute exposures are estimated to be 173 parts per billion

(ppb)for surface water and 3.1 ppb for ground water and for chronic exposures for non-cancer assessments are estimated to be 33 ppb for surface water and 3.1 ppb for ground 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 173 ppb for surface water was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 33 ppb for surface water 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). Azoxystrobin is currently registered for the following uses that could result in residential exposures: residential turf grass and ornamentals, as well as indoor surfaces. EPA assessed residential exposure using the following assumptions. Residential handlers may receive short-term dermal and inhalation exposure to azoxystrobin when mixing, loading and applying the formulations. Adults and children may be exposed to azoxystrobin residues from dermal contact with foliage/surfaces during postapplication activities. Toddlers may receive short- and intermediate-term oral exposure from incidental ingestion during postapplication activities. 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.” EPA has not found azoxystrobin to share a common mechanism of toxicity with any other substances, and azoxystrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that azoxystrobin does not have 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 EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold

(10X)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 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 (Food Quality Protection Act) safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. *Prenatal and postnatal sensitivity* . The available studies do not indicate any evidence of increased susceptibility and there are no residual uncertainties with regard to prenatal toxicity in rats or rabbits following *in utero* and/or postnatal exposure to azoxystrobin. In the prenatal developmental toxicity studies in rats and rabbits and the 2-generation reproduction study in rats, any observed toxicity to the offspring occurred at equivalent or higher doses than it did to parental animals. 3. *Conclusion* . The Agency has retained the FQPA SF at 3X, for the following reasons: i. The toxicology data base is complete. ii. The developmental and reproductive toxicity data do not indicate increased susceptibility of rats or rabbits to *in utero* and/or postnatal exposure. iii. Although a NOAEL was not identified in the study used to derive the aPAD, a 3X (as opposed to a 10X) is adequate to extrapolate a NOAEL due to the low concern for the effect seen taking into account the nature of the effect seen (transient diarrhea) and the overall toxicity of this chemical; iv. The acute dietary food exposure assessment utilizes existing and proposed tolerance level residues and 100 PCT information for all commodities; v. The chronic dietary exposure analysis for azoxystrobin is a somewhat refined assessment using less than 100% of the crop treated data for selected existing crops (but a 100 PCT value for all new crops); vi. The exposure assessments will not underestimate the potential dietary (food and drinking water) or non-dietary exposures for infants and children from the use of azoxystrobin; vii. The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations which are not likely to be exceeded; and viii. The residential postapplication assessment is based upon the residential standard operating procedures. The assessment is based upon surrogate study data. These data are reliable and are not expected to underestimate risk to adults or children. The residential SOPs are based upon reasonable “worst-case” assumptions and are not expected to underestimate risk. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water, and does not include dermal, inhalation, or incidental oral exposure. Using these exposure assumptions, EPA has concluded that acute exposure to azoxystrobin will occupy 70% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure, and 25% of the aPAD for the U.S. population as a whole. 2. *Chronic risk* . The chronic aggregate risk assessment takes into account average estimates of exposure to azoxystrobin from consumption in food and drinking water. Using these exposure assumptions, EPA has concluded that chronic exposure to azoxystrobin will utilize 15% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure, and 6% of the cPAD for the U.S. population as a whole. 3. *Short-term risk* . Short-term aggregate exposure takes into account short-term (1-30 day) residential exposure plus chronic exposure to food and drinking water (considered to be a background exposure level). Azoxystrobin is currently registered for uses that could result in short-term residential exposure both for adults (because there is a residential handler inhalation exposure scenario) and for toddlers and children (because there is a residual post-application oral exposure scenario). Dermal studies with azoxystrobin identified no toxic endpoints so dermal exposure to azoxystrobin is not expected to pose a short-term risk. The Agency has determined that it is appropriate to aggregate chronic exposure through food and drinking water with short-term residential exposures to azoxystrobin in performing this assessment. High-end estimates of residential exposure are used in the short-term assessment but average (i.e., chronic) exposure values are used for food and drinking water exposure. Toddlers' incidental oral exposure is assumed to include hand-to-mouth exposure, object-to-mouth exposure, and exposure via incidental ingestion of soil. Using the exposure assumptions described in this unit for short-term exposures, EPA has calculated the following aggregated short-term food, water, and residential exposures and resulting MOEs. For the U.S. population and all assessed subgroups the NOAEL used was 25 milligrams/kilograms/day (mg/kg/day). For the U.S. population the estimated food and drinking water exposure was 0.009878 mg/kg/day, the residential exposure estimate was 0.00011 mg/kg/day, and the aggregate MOE was 2503. For the subgroup children (1-2 years) the estimated food and drinking water exposure was 0.026629 mg/kg/day, the residential exposure estimate was 0.089 mg/kg/day, and the aggregate MOE was 216. For the subgroup youth (13-19 years) the estimated food and drinking water exposure was 0.009499 mg/kg/day, the residential exposure estimate was 0.00011 mg/kg/day, and the aggregate MOE was 2602. For the subgroup females (13-49 years old) the estimated food and drinking water exposure was 0.008081 mg/kg/day, the residential exposure estimate was 0.00011 mg/kg/day, and the aggregate MOE was 3052. None of these MOEs exceeds the Agency's level of concern for azoxystrobin. The level of concern for azoxystrobin is for MOEs below 100. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account intermediate-term (1 to 6 months) residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Azoxystrobin is currently registered for uses that could result in intermediate-term residential oral exposure for toddlers and children, so an exposure assessment was conducted for that scenario. No endpoint has been selected for intermediate-term dermal exposure to azoxystrobin so no dermal assessment was performed. Intermediate-term residential handler scenarios are not expected to occur, so this risk assessment was not conducted for adults. The Agency has determined that it is appropriate to aggregate chronic exposure to azoxystrobin through food and drinking water with intermediate-term residential exposures to azoxystrobin in doing this assessment. High-end estimates of residential exposure are used in the intermediate-term assessment but average (i.e., chronic) exposure values are used for food and drinking water exposure. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures aggregated result in an aggregate MOE for the population subgroup children 1-2 years old of 291, which does not exceed the Agency's level of concern. This value and MOE are derived from a NOAEL for this subgroup of 20 mg/kg/day, an LOC MOE of 100, an estimated average food and drinking water exposure of 0.026629 mg/kg/day, and an estimated oral residential exposure of 0.042 mg/kg/day. 5. *Aggregate cancer risk for U.S. population* .The Agency has determined that azoxystrobin is not likely to be a human carcinogen, and thus azoxystrobin is not expected to pose a 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, or to infants and children from aggregate exposure to azoxystrobin residues. IV. Other Considerations A. Analytical Enforcement Methodology For analysis of plant commodities for residues of azoxystrobin and the Z isomer of azoxystrobin a gas chromatography with nitrogen phosphorus detector (GC/NPD) method (RAM 243/04) has been validated by the Agency, revised, and sent to the Food and Drug Administration

(FDA)for inclusion in the Pesticide Analytical Manual (PAM), Volume II. This method is adequate for enforcement of 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 No CODEX maximum residue levels

(MRLs)have been established for azoxystrobin. No Canadian or Mexican MRLs have been established for azoxystrobin in or on the crops for which tolerances are being established in this document. C. Revisions to Petitioned-For Tolerances Based upon review of the data supporting the petition, EPA is not modifying the existing tolerances for ruminant and swine raw agricultural commodities

(RACs)because a recalculation of the dietary burdens of ruminants and swine indicates that no such changes are necessary, while the proposed kidney and liver tolerances are covered by existing meat byproducts tolerances. EPA is not establishing tolerances for poultry RACs because a recalculation of dietary burdens for poultry continues to indicate that there is no reasonable expectation of finite residues in poultry commodities. EPA is raising the proposed tolerance for sorghum grain from 9 ppm to 11 ppm based on a review of the residue field trial data and EPA's statistical examination of the residue data. The proposed tolerance of 112 ppm in or on aspirated grain fractions is being raised to 420 ppm based on a residue for sorghum grain of 8.46 ppm and a processing factor of 49.4x. EPA is reducing the proposed tolerance of 30 ppm in or on wheat forage to 25 ppm based on a review of the wheat forage field trial data and EPA's statistical examination of the residue data; these data have also been translated to barley, forage with the result that this proposed tolerance is also being reduced from 30 to 25 ppm. A review of the residue data from use on cotton leads EPA to reduce the proposed tolerance for undelinted cotton seed from 0.7 to 0.6 ppm and to increase the proposed tolerance for cotton gin byproducts from 35 to 45 ppm. EPA is also raising the proposed tolerance for non-grass animal feeds, forage from 35 to 45 ppm and the proposed tolerance for non-grass animal feeds, hay from 100 to 120 ppm based on a review of the field trial data for use on alfalfa and clover forage and hay and EPA's statistical examination of the residue data. EPA is also revoking the time-limited tolerance for Brassica, head and stem, subgroup 5A of 30 ppm, and for safflower, seed at 1.0 ppm, both in 40 CFR 180.507(b), because they expired on December 31, 2006, and June 30, 2008, respectively. Furthermore, Brassica, head and stem, subgroup 5A and safflower, seed have existing tolerances under 40 CFR 180.507(a)(1). The rice, wild time-limited tolerance in 40 CFR 180.507(b) is also being revoked because it is being superceded by a permanent tolerance for rice, wild, grain. V. Conclusion Therefore, tolerances are established for combined residues of azoxystrobin (methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and the Z isomer of azoxystrobin (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on animal feed, nongrass, forage, group 18 at 45 ppm; animal feed, nongrass, hay, group 18 at 120 ppm; barley, forage at 25 ppm; cotton, gin byproducts at 45 ppm; cotton, undelinted seed at 0.6 ppm; grain, aspirated fractions at 420 ppm; rice, wild, grain at 5.0 ppm; sorghum, forage at 25 ppm; sorghum, grain at 11 ppm; sorghum, stover at 40 ppm; and wheat, forage at 25 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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: June 30, 2008. 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 180.507 is amended by: i. Removing the first entry for “grain, aspirated fractions” at 10 ppm in paragraph (a)(1). ii. Revising the entries “cotton, gin byproducts”; “cotton, undelinted seed”; and “grain, aspirated fractions.” iii. Alphabetically adding entries to the table in paragraph (a)(1). iv. Removing the text of paragraph

(b)and reserving the paragraph designation and heading. § 180.507 Azoxystrobin; tolerances for residues.

(a)*General* .

(1)* * * Commodity Parts per million * * * * * Animal feed, nongrass, forage, group 18 45 Animal feed, nongrass, hay, group 18 120 * * * * * Barley, forage 25 * * * * * Cotton, gin byproducts 45 Cotton, undelinted seed 0.6 * * * * * Grain, aspirated fractions 420 * * * * * Rice, wild, grain 5.0 * * * * * Sorghum, forage 25 Sorghum, grain 11 Sorghum, stover 40 * * * * * Wheat, forage 25 * * * * *

(b)*Section 18 emergency exemption.* [Reserved] [FR Doc. E8-15517 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0871; FRL-8370-2] Flumioxazin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of flumioxazin in or on corn, field grain; corn, field forage; and corn, field stover. Valent U.S.A. Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0871. 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: Joanne I. Miller, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-6224; e-mail address: *miller.joanne@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). • 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 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 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-2007-0871 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 September 8, 2008. 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-2007-0871, 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. Petition for Tolerance In the **Federal Register** of September 28, 2007 (72 FR 55204) (FRL-8147-1), 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 7F7243) by Valent U.S.A. Corporation, 1600 Riviera Avenue, Suite 200, Walnut Creek, CA 94596. The petition requested that 40 CFR 180.568 be amended by establishing tolerances for residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 *H* -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 *H* -isoindole-1,3(2 *H* )-dione, in or on corn, field grain; corn, field forage; and corn, field stover at 0.02 parts per million (ppm). That notice referenced a summary of the petition prepared by Valent U.S.A. Corporation, 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. III. Aggregate Risk Assessment and Determination of Safety 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....” Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for residues of flumioxazin on corn, field grain; corn, field forage; and corn, field stover at 0.02 ppm. EPA's assessment of exposures and risks associated with establishing tolerances 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. Flumioxazin has mild or no acute toxicity when administered orally, dermally, or by inhalation. It has little or no toxicity with regard to eye irritation or skin irritation and is not a dermal sensitizer. Subchronic and chronic toxicity studies demonstrated that the target organs of flumioxazin are the liver, spleen and cardiovascular system. Developmental effects were observed in developmental rat studies. These effects were fetal cardiovascular anomalies (especially ventricular septal defects). Flumioxazin has been classified as a “Not Likely Human Carcinogen,” based on the lack of carcinogenicity in a 2-year rat study, an 18-month mouse study, and a battery of mutagenic studies. Specific information on the studies received and the nature of the adverse effects caused by flumioxazin 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 document “Flumioxazin; Human Health Risk Assessment for the Proposed Food Use on Field Corn,” at page 39 in docket ID number EPA-HQ-OPP-2007-0871. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure

(POD)is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL or a Benchmark Dose

(BMD)approach is sometimes used for risk assessment. Uncertainty/safety factors

(UFs)are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure

(MOE)called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for flumioxazin used for human risk assessment can be found at *http://www.regulations.gov* in document “Flumioxazin; Human Health Risk Assessment for the Proposed Food Use on Field Corn,” at page 23 in docket ID number EPA-HQ-OPP-2007-0871. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to flumioxazin, EPA considered exposure under the petitioned-for tolerances as well as all existing flumioxazin tolerances in (40 CFR 180.568). EPA assessed dietary exposures from flumioxazin 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 effect was identified for the general population. However, EPA identified potential acute effects, e.g., cardiovascular effects in offspring, for the population subgroup, females 13 to 49 years. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture

(USDA)1994-1996 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances (current and proposed) were treated (100% crop treated assumption) and contain tolerance-level residues. Percent crop treated

(PCT)and/or anticipated residues were not used in the acute risk assessment. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 CSFII. As to residue levels in food, EPA assumed all foods for which there are tolerances (current and proposed) were treated (100 PCT assumption) and contain tolerance-level residues. Percent crop treated

(PCT)and/or anticipated residues were not used in the risk assessment. iii. *Cancer* . The Agency has determined that flumioxazin is “not likely to be a human carcinogen” based on the lack of carcinogenicity in a 2-rat study, an 18 month mouse study, and a battery of mutagenic studies. Therefore, a quantitative exposure assessment to evaluate cancer risk is unnecessary. 2. *Dietary exposure from drinking water* . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flumioxazin and its degradates, 482-HA and APF, in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flumioxazin and its degradates. 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* . Based on the First Index Reservoir Screening Tool (FIRST), and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of flumioxazin for acute exposures are estimated to be 34 parts per billion

(ppb)for surface water and 48 ppb for ground water. The EDWCs for chronic exposures for non-cancer assessments are estimated to be 18 ppb for surface water and 48 ppb for ground 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 48 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 48 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). Flumioxazin is not registered for any specific use patterns 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.” EPA has not found flumioxazin to share a common mechanism of toxicity with any other substances, and flumioxazin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flumioxazin does not have 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 EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold

(10X)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 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 (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. *Prenatal and postnatal sensitivity* . The pre-natal and post-natal toxicity database for flumioxazin includes the rat and rabbit developmental toxicity studies and the 2-generation reproduction toxicity study in rats. There is evidence of quantitative susceptibility following oral and dermal exposures to rats. Following *in utero* exposures, developmental effects (cardiovascular anomalies) were seen in the absence of maternal toxicity. There is no evidence (quantitative or qualitative) of susceptibility following *in utero* oral exposure in rabbits. No developmental toxicity was seen at the highest dose tested (3x the Limit-Dose). There is quantitative evidence of susceptibility in the multi-generation reproduction study where effects in offspring were seen at doses lower than those which induced effects in parental animals. Although increased pre-natal and post-natal quantitative susceptibility was seen in rats, the Agency concluded that there is a low concern and no residual uncertainties for pre-natal and/or post-natal toxicity effects of flumioxazin because: i. Developmental toxicity (including cardiovascular abnormalities) NOAELs and LOAELs from pre-natal exposure are well characterized after oral and dermal exposure, ii. The off-spring toxicity NOAEL and LOAEL from post-natal exposure are well characterized, iii. The dose selected for risk assessment is protective of all potential effects. 3. *Conclusion* . EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for flumioxazin is complete. ii. There is no indication that flumioxazin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. Although there is quantitative evidence of increased susceptibility in the pre-natal developmental studies and post-natal multi-generation study in rats, EPA did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of flumioxazin. The degree of concern for pre-natal and/or post-natal toxicity is low. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues for all commodities. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to flumioxazin in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by flumioxazin. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to flumioxazin will occupy 8% of the aPAD for (females 13 to 49) the population group receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flumioxazin from food and water will utilize 19% of the cPAD for (Infants less than 1 year old) the population group receiving the greatest exposure. There are no residential uses for flumioxazin. 3. *Short-term risk* . Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flumioxazin is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to flumioxazin through food and water and will not be greater than the chronic aggregate risk. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flumioxazin is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to flumioxazin through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 5. *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 flumioxazin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography/nitrogen- phosphorus detection) 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 no established or proposed Canadian, Mexican or Codex maximum residue levels

(MRLs)for residues of flumioxazin in plant commodities subject to this action. V. Conclusion Therefore, tolerances are established for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 *H* -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 *H* -isoindole-1,3(2 *H* )-dione, in or on corn, field grain; corn, field forage; and corn, field stover at 0.02 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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: June 26, 2008 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 180.568 is amended by alphabetically adding the following commodities to the table in paragraph

(a)to read as follows: § 180.568 Flumioxazin; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Corn, field, forage 0.02 Corn, field, grain 0.02 Corn, field, stover 0.02 * * * * * [FR Doc. E8-15316 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0475; FRL-8367-1] Spirotetramat; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of spirotetramat and its metabolites BYI 08330-enol, BYI 08330-ketohydroxy, BYI08330-enol-, and BYI 08330-mono-hydroxy, calculated as spirotetramat equivalents, in or on vegetable, tuberous and corm, subgroup 1C; potato, flakes; onion, bulb, subgroup 3A-07; vegetable, leafy, except brassica, group 4; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; vegetable, fruiting, group 8; vegetable, cucurbit, group 9; fruit, citrus, group 10; citrus, oil; fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; almond, hulls; small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F; grape; raisin; strawberry; hop, dried cones; and for the combined residues of spirotetramat and its metabolite BYI 08330-enol, calculated as spirotetramat equivalents, in or on milk; and meat, fat, and meat byproducts of cattle, goat; sheep, and horse. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0475. 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: Rita Kumar, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-8291; e-mail address: *kumar.rita@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). • 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 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 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-2007-0475 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 September 8, 2008. 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-2007-0475, 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. Petition for Tolerance In the **Federal Register** of July 15, 2007 (FR 40877) (FRL-8137-1), 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 6F7119) by Bayer CropScience LLC, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709 . The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide spirotetramat, (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate, and its metabolite cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro4.5dec-3-en-2-one, calculated as spirotetramat equivalents, in or on the raw agricultural commodities vegetable, tuberous and corm, subgroup 1C at 1.0 parts per million (ppm); potato, granules/flakes at 2.5 ppm; onions, dry bulb, subgroup 3A at 0.3 ppm; vegetables, leafy, except brassica, group 4 at 5.0 ppm brassica, head and stem, subgroup 5A at 3.0 ppm; brassica, leafy greens, subgroup 5B at 16.0 ppm; vegetables, fruiting, group 8 at 1.0 ppm; tomato, dried pomace at 2.5 ppm; vegetable, cucurbit, group 9 at 0.2 ppm; fruit, citrus, group 10 at 0.5 ppm; citrus, oil at 4.0 ppm; fruit, pome, group 11 at 0.5 ppm; fruit, stone, group 12 at 2.0 ppm; nut, tree, group 14 at 0.5 ppm; almond, hulls at 9.0 ppm; grape at 1.0 ppm; grape, raisin at 2.5 ppm; hop at 10.0 ppm; strawberry at 0.5 ppm; cattle, goat, hog, sheep and horse, meat at 0.01 ppm; cattle, goat, hog, sheep and horse, fat at 0.01 ppm; cattle, goat, hog, sheep and horse, liver at 0.01 ppm; cattle, goat, hog, sheep and horse, meat byproducts, except liver at 0.02 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience, 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 revised tolerance expression for vegetable, tuberous and corm, subgroup 1C; potato, granules/flakes; vegetables, leafy, except brassica, group 4; brassica, head and stem, subgroup 5A; brassica, leafy greens, subgroup 5B; vegetables, fruiting, group 8; tomato, dried pomace; vegetable, cucurbit, group 9; fruit, citrus, group 10; citrus, oil; fruit, pome, group 11; fruit, stone, group 12; nut, tree, group 14; small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F; grape; raisin; strawberry; cattle, goat, hog, sheep and horse, meat; cattle, goat, hog, sheep and horse, fat; cattle, goat, hog, sheep and horse, liver; cattle, goat, hog, sheep and horse, meat byproducts, except liver. A tolerance for milk was also included. The reasons for these changes are explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety 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. . . .” Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for combined residues of spirotetramat. EPA's assessment of exposures and risks associated with establishing tolerances 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. The acute, short-term, and long-term toxicity of spirotetramat is well understood. Spirotetramat technical demonstrated moderate to low acute toxicity via the oral, dermal, and inhalation routes. Spirotetramat is non-irritating to the skin, although it is an irritant to the eyes and exhibits a skin-sensitization potential in animals and humans. The thyroid and thymus glands were target organs in oral subchronic toxicity studies in the dog; whereas, the testes-epididymides were the target organs following subchronic oral treatment of rats. Long-term toxicity studies reflected the short-term toxicological profile of spirotetramat with the thymus and thyroid as target organs following one-year oral exposure of dogs. Chronic exposure of rats to spirotetramat also reflected the subchronic pattern of testicular toxicity. No evidence of tumor formation was found following long-term studies of rodents, and spirotetramat was also negative for mutagenicity and clastogenicity in several standard in vivo and in vitro assays. The reproductive and developmental toxicity potential of spirotetramat was tested in rats and rabbits. In addition to testicular histopathology observed following subchronic and chronic exposure of rats to spirotetramat, male reproductive toxicity was recorded in the two-generation reproductive toxicity study. However, development of the sexual organs of offspring (balano-preputial separation, vaginal opening) was unaffected. In an investigative study designed to explore the time of onset of testicular toxicity in rats, decreased epididymal sperm counts were noted after 10 days of exposure. Therefore, repeated dosing with spirotetramat is necessary to produce male reproductive toxicity in rats. Similar effects were observed after repeated dosing with the enol metabolite of spirotetramat. Developmental toxicity was not observed with spirotetramat in the absence of maternal toxicity in either the rat or rabbit. Specific information on the studies received and the nature of the adverse effects caused by spirotetramat 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 document *Spirotetramat Human Health Risk Assessment for Proposed Uses on Citrus (Crop Group 10); Cucurbit Vegetables (Crop Group 9); Fruiting Vegetables (Crop Group 8); Grape (Crop Subgroup 13F); Hops; Leafy Brassica Vegetables (Crop Group 5); Leafy Non-Brassica Vegetables (Crop Group 4); Pome Fruit (Crop Group 11); Potato and Other Tuberous and Corm Vegetables (Crop Subgroup 1C); Stone Fruit (Crop Group 12); Tree Nuts (Crop Group 14); Onions; Strawberries; Livestock Commodities* ; and *Greenhouses/Nurseries* , pages 38-58 in docket ID number EPA-HQ-OPP-2007-0475. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure

(POD)is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose

(BMD)approach is sometimes used for risk assessment. Uncertainty/safety factors

(UFs)are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure

(MOE)called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for spirotetramat used for human risk assessment can be found at *http://www.regulations.gov* in document *Spirotetramat Human-Health Risk Assessment for Proposed Uses on Citrus (Crop Group 10); Cucurbit Vegetables (Crop Group 9); Fruiting Vegetables (Crop Group 8); Grape (Crop Subgroup 13F); Hops; Leafy Brassica Vegetables (Crop Group 5); Leafy Non-Brassica Vegetables (Crop Group 4); Pome Fruit (Crop Group 11); Potato and Other Tuberous and Corm Vegetables (Crop Subgroup 1C); Stone Fruit (Crop Group 12); Tree Nuts (Crop Group 14); Onions; Strawberries; Livestock Commodities* ; and *Greenhouses/Nurseries* , page 21 in docket ID number EPA-HQ-OPP-2007-0475. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to spirotetramat, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from spirotetramat 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 one-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100 percent crop treated (PCT), and tolerance-level residues for all foods. Empirical and DEEM TM (ver. 7.81) default processing factors were used for processed commodities. Drinking water was incorporated directly in the dietary assessment using the acute concentration for surface water generated by the First Index Resevoir Screening Tool (FIRST) model. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA conducted a conservative chronic dietary assessment assuming average field-trial residues, empirical and DEEM TM (ver. 7.81) default processing factors, and 100% CT. Drinking water was incorporated directly into the dietary assessment using the chronic concentration for surface water generated by the FIRST model. iii. *Cancer* . Spirotetramat was classified as “not likely to be carcinogenic to humans.” Therefore, a quantitative cancer dietary exposure assessment was not performed. 2. *Dietary exposure from drinking water* . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for spirotetramat and its metabolites in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of spirotetramat. 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* . Based on the FIRST and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of spirotetramat and its metabolites: i. For acute exposures are estimated to be 0.212 parts per billion

(ppb)for surface water and 3.96x10- 4 ppb for ground water; ii. For chronic exposures for non-cancer assessments are estimated to be 1.37x10- 3 ppb for surface water and 3.96x10- 4 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. a. For acute dietary risk assessment, the water concentration value of 0.212 ppb was used to assess the contribution to drinking water. b. For chronic dietary risk assessment, the water concentration of value 1.37x10- 3 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). Spirotetramat is not registered for any specific use patterns 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.” EPA has not found spirotetramat to share a common mechanism of toxicity with any other substances, and spirotetramat does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that spirotetramat does not have 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 EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold

(10X)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 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 (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. *Prenatal and postnatal sensitivity* . There is no evidence of increased susceptibility of rat or rabbit to prenatal or postnatal exposure to spirotetramat. In the rat developmental toxicity study, toxicity to offspring was observed at the same dose as maternal toxicity, which was also the limit dose. In the developmental toxicity study in the rabbit, only maternal toxicity was observed. In both reproductive toxicity studies, toxicity to offspring (decreased body weight) was observed at the same dose as parental toxicity. Therefore, no evidence of increased susceptibility of offspring was found across four relevant toxicity studies with spirotetramat. 3. *Conclusion* . EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for spirotetramat is complete. ii. There is no indication that spirotetramat is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Clinical signs of toxicity and decreased motor activity were observed in adult rats following a single dose of spirotetramat in the acute neurotoxicity study in the rat; however, these effects only attained statistical significance at high doses and were not observed at the limit dose in the acute oral toxicity study in the rat. There is no concern for neurotoxicity with spirotetramat in the developing animal based on the fact that brain dilation in the one-year dog study is most likely a congenital anomaly that was not observed in any other study in the spirotetramat database, and the fact that the structurally related compounds spirodiclofen and spiromesifen are not neurotoxic in adults or young. iii. There is no evidence that spirotetramat results in increased susceptibility *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to spirotetramat in drinking water. These assessments will not underestimate the exposure and risks posed by spirotetramat. v. There are no registered or proposed uses of spirotetramat which could result in residential exposure. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the margin of exposure

(MOE)called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to spirotetramat will occupy 10% of the aPAD for (children 1-2 years old) the population group receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to spirotetramat from food and water will utilize 77% of the cPAD for (children 1-2 years old) the population group receiving the greatest exposure. There are no residential uses for spirotetramat. 3. *Short-term risk* . Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Spirotetramat is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to spirotetramat through food and water and will not be greater than the chronic aggregate risk. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Spirotetramat is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to spirotetramat through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 5. *Aggregate cancer risk for U.S. population.* Spirotetramat has been classified as “Not Likely to be Carcinogenic to Humans.” Spirotetramat is not expected to pose a 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, or to infants and children from aggregate exposure to spirotetramat residues. IV. Other Considerations A. Analytical Enforcement Methodology If the method is not published in the Pesticide Analytical Manual, but has been approved by EPA, use the following: Adequate enforcement methodology liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) 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 no CODEX or Mexican maximum residue limits

(MRLs)for spirotetramat. Canadian MRLs have been established and are harmonized with the US. C. Response to Comments There were no comments received in response to the notice of filing. D. Revisions to Petitioned-For Tolerances Based on residue chemistry data submitted with this petition, several petitioned-for tolerances were revised, and it was considered necessary to establish a tolerance for milk. A chart listing the petitioned-for tolerances and EPA recommended tolerances can be found at *http://www.regulations.gov* in document *Spirotetramat Human Health Risk* Assessment for Proposed Uses on Citrus (Crop Group 10); Cucurbit Vegetables (Crop Group 9); Fruiting Vegetables (Crop Group 8); Grape (Crop Subgroup 13F); Hops; Leafy Brassica Vegetables (Crop Group 5); Leafy Non-Brassica Vegetables (Crop Group 4); Pome Fruit (Crop Group 11); Potato and Other Tuberous and Corm Vegetables (Crop Subgroup 1C); Stone Fruit (Crop Group 12); Tree Nuts (Crop Group 14); Onions; Strawberries; Livestock Commodities; and *Greenhouses/Nurseries* page 65 in docket ID number EPA-HQ-OPP-2007-0475. V. Conclusion Therefore, tolerances are established for combined residues of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate]) and its metabolites BYI 08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-en-2-one), BYI 08330-ketohydroxy (cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro 4.5 decane-2,4-dione), BYI08330-enol-Glc (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro 4.5 dec-3-en-4-yl beta-D-glucopyranoside), and BYI 08330-mono-hydroxy (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 decan-2-one), calculated as spirotetramat equivalents, in or on the following commodities: Fruit, citrus, group 10 at 0.60 ppm; citrus, oil at 6.0 ppm; vegetable, leafy, except brassica, group 4 at 9.0 ppm; fruit, pome, group 11 at 0.70 ppm; fruit, stone, group 12 at 4.5 ppm; small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F at 1.3 ppm; grape, raisin at 3.0 ppm; strawberry at 0.40 ppm; onion, bulb, subgroup 3A-07 at 0.30 ppm; vegetable, fruiting, group 8 at 2.5 ppm; vegetable, cucurbit, group 9 at 0.30 ppm; brassica, head and stem, subgroup 5A at 2.5 ppm; brassica, leafy greens, subgroup 5B at 8.0 ppm; vegetable, tuberous and corm, subgroup 1C at 0.60 ppm; potato, flakes at 1.6 ppm; nut, tree, group 14 at 0.25 ppm; almond, hulls at 9.0 ppm; hop, dried cones at 10 ppm. Tolerances are also established for the combined residues of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro 4.5 dec-3-en-4-yl-ethyl carbonate) and its metabolite BYI 08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-en-2-one), calculated as spirotetramat equivalents, in/on the following livestock commodities: Milk at 0.01 ppm; cattle, meat at 0.02 ppm; cattle, fat at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat at 0.02 ppm; goat, fat at 0.02 ppm; goat, meat byproducts at 0.02 ppm; sheep, meat at 0.02 ppm; sheep, fat at 0.02 ppm; sheep, meat byproducts at 0.02 ppm; horse, meat at 0.02 ppm; horse, fat at 0.02 ppm; horse, meat byproducts at 0.02 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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: June 24, 2008. Debra Edwards, Director, 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 180.641 is added to read as follows: § 180.641 Spirotetramat; tolerances for residues.

(a)*General* .

(1)Tolerances are established for residues of the insecticide spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate) and its metabolites BYI 08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-en-2-one), BYI 08330-ketohydroxy (cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro 4.5 decane-2,4-dione), BYI08330-enol-Glc (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro 4.5 dec-3-en-4-yl beta-D-glucopyranoside), and BYI 08330-mono-hydroxy (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 decan-2-one), calculated as spirotetramat equivalents, in or on the following raw agricultural commodities: Commodity Parts per million Almond, hulls 9.0 Brassica, head and stem, subgroup 5A 2.5 Brassica, leafy, subgroup 5B 8.0 Citrus, oil 6.0 Fruit, citrus, group 10 0.60 Fruit, pome, group 11 0.70 Fruit, stone, group 12 4.5 Grape, raisin 3.0 Hop, dried cones 10.0 Nut, tree, group 14 0.25 Onion, bulb, subgroup 3A-07 0.3 Potato, flakes 1.6 Small fruit vine climbing subgroup, except fuzzy kiwifruit, subgroup 13-07F 1.3 Strawberry 0.40 Vegetable, cucurbit, group 9 0.30 Vegetable, fruiting, group 8 2.5 Vegetable, leafy, except Brassica, group 4 9.0 Vegetable, tuberous and corm, subgroup 1C 0.60

(2)Tolerances are also established for the combined residues of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro [4.5] dec-3-en-4-yl-ethyl carbonate) and its metabolite BYI 08330-enol (cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro 4.5 dec-3-en-2-one), calculated as spirotetramat equivalents, in or on the following commodities: Commodity Parts per million Cattle, fat 0.02 Cattle, meat 0.02 Cattle, meat byproducts 0.02 Goat, fat 0.02 Goat, meat 0.02 Goat, meat byproducts 0.02 Horse, fat 0.02 Horse, meat 0.02 Horse, meat byproducts 0.02 Milk 0.01 Sheep, fat 0.02 Sheep, meat 0.02 Sheep, meat byproducts 0.02

(b)Section 18 emergency exemptions. [Reserved]

(c)Tolerances with regional registrations. [Resereved]

(d)Indirect or inadvertant residues. [Reserved] [FR Doc. E8-15521 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0893; FRL-8370-9] Sethoxydim; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety, in or on various oilseed commodities. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0893. 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: Susan Stanton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-5218; e-mail address: *stanton.susan@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). • 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 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 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-2007-0893 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 September 8, 2008. 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-2007-0893, 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. Petition for Tolerance In the **Federal Register** of September 28, 2007 (72 FR 55204) (FRL-8147-1), 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 7E7232) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.412 be amended by establishing tolerances for combined residues of the herbicide sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as the herbicide), in or on cuphea, seed at 35.0 parts per million (ppm); echium, seed at 35.0 ppm; gold of pleasure, seed at 35.0 ppm; gold of pleasure, meal at 40.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; sweet rocket, seed at 35.0 ppm; crambe, seed at 35.0 ppm; and crambe, meal at 40.0 ppm. That notice referenced a summary of the petition prepared by BASF, the registrant, on behalf of IR-4, 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. III. Aggregate Risk Assessment and Determination of Safety 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....” Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for combined residues of sethoxydim and its metabolites containing the 2-cyclohexen-1-one moiety on crambe, meal at 40.0 ppm; crambe, seed at 35.0 ppm; cuphea, seed at 35.0 ppm; echium, seed at 35.0 ppm; gold of pleasure, meal at 40.0 ppm; gold of pleasure, seed at 35.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; and sweet rocket, seed at 35.0 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances 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. The acute toxicity data indicate that sethoxydim is minimally toxic via oral, dermal and inhalation routes of exposure. It is neither irritating to the eye nor the skin. With repeated dosing, the primary target organ for this chemical is the liver. In the chronic toxicity study in dogs, there were significantly increased absolute and relative liver weights accompanied by supportive clinical chemistry and histopathology. Dose-related clinical chemistry abnormalities were observed in both sexes and included increased alkaline phosphatase and aspartate aminotransferase

(ALT)and decreased albumin and cholesterol synthesis. Dose-related histopathologic lesions were found in the liver, spleen and bone marrow. A mild hepatocellular cytoplasmic alteration was found in males at all doses and in females at the mid and high doses. Adverse liver effects were also observed via the oral route in mice and via the inhalation route in rats. There was no evidence of carcinogenicity in studies in rats and mice and no evidence of mutagencity, immunotoxicity or endocrine disruption in the toxicity database for sethoxydim. In the prenatal developmental studies in rats and rabbits and reproductive toxicity study in rats, the primary effects noted in the young were fetal skeletal variations and decreases in body weight. Although effects suggestive of neurotoxicity were noted in adult and young rats in the developmental and/or reproductive toxicity studies, EPA has concluded that sethoxydim is not a neurotoxic chemical. The weight of evidence EPA considered in making this determination is discussed in more detail in Unit III.D.3.ii. Specific information on the studies received and the nature of the toxic effects caused by sethoxydim 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 in the final rule published in the **Federal Register** of September 29, 2003 (68 FR 55858) (FRL-7238-6)( *http://www.epa.gov/EPA-PEST/2003/September/Day-29/p24562.htm* ). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure

(POD)is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL or a Benchmark Dose

(BMD)approach is sometimes used for risk assessment. Uncertainty/safety factors

(UFs)are used in conjunction with the POD 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 dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, intermediate-term, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure

(MOE)called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. 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/pesticides/factsheets/riskassess.htm* . A summary of the toxicological endpoints for sethoxydim used for human risk assessment can be found at *http://www.regulations.gov* in the document *Sethoxydim: Amended human health risk assessment to support uses on the Rapeseed Crop Subgroup 20A* at page 10 in docket ID number EPA-HQ-OPP-2007-0893. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to sethoxydim, EPA considered exposure under the petitioned-for tolerances as well as all existing sethoxydim tolerances in 40 CFR 180.412. EPA assessed dietary exposures from sethoxydim 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. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that 100 percent of all crops with existing or pending tolerances are treated with sethoxydim and contain tolerance-level residues. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed that 100 percent of all crops with existing or pending tolerances are treated with sethoxydim and contain tolerance-level residues. iii. *Cancer* . Based on the results of carcinogenicity studies in rats and mice, EPA classified sethoxydim as “not likely to be carcinogenic to humans”; therefore, an exposure assessment for evaluating cancer risk is not needed for this chemical. iv. *Anticipated residue and percent crop treated

(PCT)information* . EPA did not use anticipated residue or PCT information in the dietary assessment for sethoxydim. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. *Dietary exposure from drinking water* . The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sethoxydim in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sethoxydim. 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* . Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of sethoxydim for acute exposures are estimated to be 130 parts per billion

(ppb)for surface water and 1.5 ppb for ground water; and for chronic exposures for non-cancer assessments are estimated to be 16 ppb for surface water and 1.5 ppb for ground 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 130 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 16 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). Sethoxydim is currently registered for the following uses that could result in residential exposures: Ornamentals and flowering plants, recreational areas, and buildings/structures (outdoor). EPA assessed residential handler and postapplication exposures using the following assumptions: Homeowners who apply sethoxydim to ornamental gardens and turf may be exposed for short-term durations via the dermal and inhalation routes. Dermal endpoints of concern were not identified for sethoxydim; therefore, dermal exposure and risk assessments are not appropriate. Short-term inhalation exposure was assessed for residential handlers who mix, load and apply liquid sethoxydim products using low-pressure hand wands, backpack sprayers and garden hose-end sprayers. Sethoxydim can be used in areas, such as home lawns, that may be frequented by adults and children. There is potential for dermal exposure of adults and children as well as incidental oral exposure of children following application of sethoxydim to such areas. Post-application inhalation exposure of adults and children is expected to be negligible. Since there are no dermal endpoints of concern for sethoxydim, only post-application incidental oral exposure of children was assessed. EPA assessed incidental oral exposure of toddlers from hand-to-mouth, object-to-mouth and incidental soil ingestion activities using Standard Operating Procedures for Residential Exposure Assessments. 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.” EPA has not found sethoxydim to share a common mechanism of toxicity with any other substances, and sethoxydim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sethoxydim does not have 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 EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408(b)(2)(c) of FFDCA provides that EPA shall apply an additional tenfold

(10X)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 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 (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. *Prenatal and postnatal sensitivity* . The prenatal and postnatal toxicity database for sethoxydim includes rat and rabbit developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility of *in utero* rabbit fetuses following exposure to sethoxydim in the rabbit developmental study; however, evidence of increased susceptibility was noted in the rat developmental and reproduction toxicity studies as described below: There was some evidence of qualitative susceptibility in the rat developmental study with the occurrence of more severe effects in the fetuses (delayed ossification and tail abnormalities) than in the maternal animals (transient clinical signs including: Irregular gait and decreased activity) at the same dose. The degree of concern for increased susceptibility in this study is low and there are no residual uncertainties for the following reasons: The effects in the pups were of low incidence and only observed at a high dose that is considered to be close to a limit dose. In addition, these effects were seen in the presence of clear maternal toxicity and clear NOAELs and LOAELs were established for both maternal and developmental toxicities. In the 2-generation reproduction study in rats, pups showed decreases in body weight (11 to 13%) during lactation at the high dose. At the same dose, adult female animals exhibited body weight losses (8 to 10%) that are considered too small to qualify as an adverse effect. The determination that body weight effects occurred in pups at a dose that did not result in maternal toxicity is technically an indication of quantitative susceptibility. However, the degree of concern for the body weight changes in pups is low, since the weight changes are considered minimal and the differences observed in body weight losses between the adult and young animals are marginal. Characterization of the body weight changes as an adverse effect in the pups is considered conservative (protective). 3. *Conclusion* . EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: i. The toxicity database for sethoxydim is complete. ii. Sethoxydim is not considered to be a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Clinical signs suggestive of neurotoxicity (including irregular gait, decreased activity, excessive salivation, and anogenital staining) were observed in adult rats in the developmental toxicity study. Because the clinical signs occurred shortly after dosing, only occurred at very high treatment doses (over one half the limit dose) and were transitory, it is unlikely that the signs observed are the result of a primary systemic effect on the nervous system but, rather, are reflective of the general toxicity at a high dose. An increased incidence of fetal skeletal variations due to delayed ossification was seen in young rats in the developmental and reproductive toxicity studies. In the rat prenatal study, tail abnormalities (filamentous tail or lack of a tail) were noted. These abnormalities were observed at a very low incidence and at high treatment doses. In the 2-generation reproduction study in rats, a tail anomaly (short, thread-like tail, no anal opening, hindlimbs curved toward central midline) was found in one pup in the F2b generation (1/344 total pups; in 1/4 litters). Tail abnormalities are sometimes thought to relate to central nervous system

(CNS)malformations; however, in this case, these tail abnormalities are not likely to be the result of a primary neural tube effect. In the rat prenatal study, there is no description of any effect on neural tube-derived structures. No other effects suggestive of neurotoxicity were seen in toxicology studies conducted with sethoxydim. Furthermore, cyclohexones, the class of compounds that includes sethoxydim, are not known to cause neurotoxicity or developmental malformations of the nervous system. Based on the weight of the evidence, EPA concluded that sethoxydim is not neurotoxic. iii. There is no evidence that sethoxydim results in increased susceptibility in *in utero* rabbits in the prenatal developmental study. Although there is qualitative evidence of increased susceptibility in the prenatal developmental study in rats and equivocal evidence of quantitative susceptibility in the 2-generation reproduction study in rats, the degree of concern is low, and the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of sethoxydim. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed assuming 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to sethoxydim in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sethoxydim. E. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to sethoxydim will occupy 17% of the aPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sethoxydim from food and water will utilize 94% of the cPAD for children, 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of sethoxydim is not expected. 3. *Short-term risk* . Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Sethoxydim is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to sethoxydim, except residential inhalation exposures. It is not appropriate to aggregate dietary (i.e., oral) exposures and inhalation exposures because the toxic effects identified for the oral and inhalation exposure pathways differ. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in an aggregate MOE of 1,300 for children 1 to 2 years old (toddlers). The aggregate MOE for children includes food, drinking water and post-application incidental oral exposures from entering turf areas previously treated with sethoxydim. Adult residential handler MOEs, based on inhalation exposure of adults who mix, load and apply liquid sethoxydim products using low-pressure hand wands, backpack sprayers or garden hose-end sprayers, range from 1.4 x 10 6 to 1.6 x 10 6 , with hose-end sprayers resulting in the lowest MOE. As noted in the previous paragraph, it is not appropriate to aggregate chronic exposure from food and water with inhalation exposures. Post-application inhalation exposure of adults and children is expected to be negligible. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Sethoxydim is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to sethoxydim through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk. 5. *Aggregate cancer risk for U.S. population* . EPA has classified sethoxydim into the category “Not Likely to be Carcinogenic to Humans.” Sethoxydim is not expected to pose a 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, or to infants and children from aggregate exposure to sethoxydim residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography with flame photometric detection in the sulfur mode; BASF Wyandotte Corporation's Method No. 30; 3/15/82; MRID 44864501; Method I, Pesticide Analytical Methods Vol. II) is available to enforce these oilseed tolerances. B. International Residue Limits There are no CODEX, Canadian or Mexican maximum residue limits

(MRLs)established on the commodities associated with this petition. V. Conclusion Therefore, tolerances are established for combined residues of sethoxydim, 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one, and its metabolites containing the 2-cyclohexen-1-one moiety, in or on crambe, meal at 40.0 ppm; crambe, seed at 35.0 ppm; cuphea, seed at 35.0 ppm; echium, seed at 35.0 ppm; gold of pleasure, meal at 40.0 ppm; gold of pleasure, seed at 35.0 ppm; hare's ear mustard, seed at 35.0 ppm; lesquerella, seed at 35.0 ppm; lunaria, seed at 35.0 ppm; meadowfoam, seed at 35.0 ppm; milkweed, seed at 35.0 ppm; mustard, seed at 35.0 ppm; oil radish, seed at 35.0 ppm; poppy, seed at 35.0 ppm; sesame, seed at 35.0 ppm; and sweet rocket, seed at 35.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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: June 30, 2008. 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 180.412 is amended by alphabetically adding the following commodities to the table in paragraph

(a)to read as follows: § 180.412 Sethoxydim; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Crambe, meal 40.0 Crambe, seed 35.0 * * * * * Cuphea, seed 35.0 * * * * * Echium, seed 35.0 * * * * * Gold of pleasure, meal 40.0 Gold of pleasure, seed 35.0 * * * * * Hare's ear mustard, seed 35.0 * * * * * Lesquerella, seed 35.0 * * * * * Lunaria, seed 35.0 Meadowfoam, seed 35.0 * * * * * Milkweed, seed 35.0 Mustard, seed 35.0 * * * * * Oil radish, seed 35.0 * * * * * Poppy, seed 35.0 * * * * * Sesame, seed 35.0 * * * * * Sweet rocket, seed 35.0 * * * * * [FR Doc. E8-15519 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0096; FRL-8372-6] Gamma-cyhalothrin; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of Gamma-cyhalothrin in or on all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food-handling establishments where food products are held, processed or prepared, pistachio and okra. Pytech Chemicals GmbH and Interregional Research Project No. 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0096. 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: BeWanda Alexander, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)305-7460; e-mail address: *alexander.bewanda@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 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-2007-0096 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 September 8, 2008. 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-2007-0096, 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. Petition for Tolerance In the **Federal Registers** of February 28, 2007 (72 FR 9000) (FRL-8115-5) and February 6, 2008 (73 FR 6964) (FRL-8350-9), 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 6H7114) by Pytech Chemicals GmbH, 9330 Zionsville Road, Indianapolis, IN 46268 and PP 7E7287 by IR-4, 500 College Road East, Suite 201 W. Princeton, NJ 08540-6635 respectively. The petitions requested that 40 CFR 180.438 be amended by establishing tolerances for residues of the insecticide gamma-cyhalothrin, (S)-alpha-cyano-3-phenoxybenzy-(Z)-(1R, 3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl-2,2-dimethycyclopropanecarboxylate, in all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food-handling establishments where food products are held, processed or prepared, at 0.01 parts per million (ppm), pistachio at 0.05 ppm, and okra at 0.20 ppm. These notices referenced a summary of the petitions prepared by Dow Agro Sciences (on behalf of Pytech Chemicals), 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. The tolerance expression under 40 CFR 180.438(a)(3) currently identifies the tolerance as a “food additive” and also lists specific instructions for use in food handling establishments under paragraphs, 180.438(a)(3)(ii) thru (v). The term “food additive tolerance” is obsolete since EPA no longer regulates pesticide residues under section 409 of the Federal Food Drug and Cosmetic Act. In addition it is no longer necessary to identify specific instructions for use in food handling establishments since these instructions are identified on the pesticide label. Therefore EPA is revising the tolerance expression under 40 CFR 180.438(a)(3) to read, “A tolerance of 0.01 part per million is established for residues of the insecticide lambda-cyhalothrin and an isomer gamma-cyhalothrin as follows:”, and is deleting sections 180.438(a)(3)(ii) thru (v). III. Aggregate Risk Assessment and Determination of Safety 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. . . .” Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in 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 for the petitioned-for tolerances for residues of gamma-cyhalothrin on all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food-handling establishments where food products are held, processed or prepared, at 0.01 ppm, pistachio at 0.05 ppm, and okra at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows. Gamma-cyhalothrin is a single, resolved isomer of the pyrethroid insecticide cyhalothrin. As such, it shares physical, chemical and biological properties with both cyhalothrin and lambda-cyhalothrin, which are mixtures of 4 and 2 isomers, respectively. Gamma-cyhalothrin is the most insecticidally active isomer of cyhalothrin/lambda-cyhalothrin, and thus the gamma-cyhalothrin technical product is considered a refined form of cyhalothrin/lambda-cyhalothrin that has been purified by removal of less-active and inactive isomers. Therefore, similar levels of insecticidal efficacy for gamma-cyhalothrin can be obtained with significantly reduced application rates as compared with either cyhalothrin or lambda-cyhalothrin. EPA has previously concluded that residue data supporting registered uses of lambda-cyhalothrin are sufficient to support registration of gamma-cyhalothrin for the same uses, as long as the use rates of gamma-cyhalothrin are no greater than half the corresponding use rates of lambda-cyhalthrin. The proposed application rates of gamma-cyhalthrin for the requested new uses (considered herein) are no greater than half of the corresponding, existing application rates for similar registered uses of lambda-cyhalthrin. Tolerances are currently established under 40 CFR 180.438 for residues of lambda-cyhalothrin in food-handling establishments.Through the use of bridging data, the toxicology database for gamma-cyhalothrin is complete using developmental, reproduction, chronic (rodent), and oncogenicity studies conducted with cyhalothrin and lambda-cyhalothrin. The nature of the toxic effects caused by lambda-cyhalothrin as well as gamma-cyhalthrin are discussed in detail in the **Federal Register** of September 27, 2002 (67 FR 60902)(FRL-7200-1). Therefore the toxicology database for gamma-cyhalothrin when bridged with cyhalothrin and lambda-cyhalothrin are complete for purposes of supporting the proposed use in food handling establishments. In the August 15, 2007 final rule, establishing tolerances for lambda-cyhalothrin on a number of crops including pistachios. EPA included residues at the tolerance level 0.05 ppm in assessing the use of lambda-cyhalothrin in/on pistachios. Since EPA considered the pistachio use in this most recent risk assessment establishing the tolerance on pistachios for gamma-cyhalothrin will not change the estimated aggregate risks resulting from use of lambda-cyhalothrin as discussed in the August 15, 2007 (72 FR 45656) **Federal Register** . Refer to this **Federal Register** document available at *http://www.regulations.gov* for a detailed discussion of the aggregate risk assessments and determination of safety. A tolerance for residues of lambda-cyhalothrin in okra has not been established; however, there are adequate residue data for lambda-cyhalothrin on fruiting vegetables (crop group 8) to support a tolerance for residues of gamma-cyhalothrin in okra; and EPA included residues on okra at the fruiting vegetable tolerance level (0.20 ppm) in the risk assessments supporting the August 15, 2007 final rule discussed in the previous paragraph. Since EPA considered the okra use in this most recent assessment establishing the tolerance on okra for gamma-cyhalothrin will not change the aggregate risks resulting from use of lambda-cyhalothrin as discussed in the August 15, 2007 (72 FR 45656) **Federal Register** . Refer to this **Federal Register** document available at *http://www.regulations.gov* for a detailed discussion of the aggregate risk assessments and determination of safety. EPA concludes that the previous risk assessments on lambda-cyhalothrin sufficiently covers the proposed gamma-cyhalothrin uses and no new aggregate risk assessment is needed for gamma-cyhalothrin. Based on the risk assessments discussed in the final rule published in the **Federal Register** August 15, 2007 (72 FR 45656, FRL 8143-1) 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 gamma-cyhalothrin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, gas chromatography/electron capture detector (GC/ECD), (ICI Method 81 (PRAM 81)) 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 no established Mexican, Canadian, or Codex MRLs (maximum residue limits) for gamma-cyhalothrin. V. Conclusion Therefore, tolerances are established for residues of gamma-cyhalothrin, (S)-alpha-cyano-3-phenoxybenzy-(Z)-(1R, 3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl-2,2-dimethycyclopropanecarboxylate, in or on all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food-handling establishments where food products are held, processed or prepared, at 0.01 ppm, pistachio at 0.05 ppm, and okra at 0.20 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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: June 30, 2008. Lois Rossi, Direction, 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 180.438 is amended by: i. Alphabetically adding okra and pistachios to the table in paragraph (a)(2). ii. Revising paragraph (a)(3). The amendments read as follows: § 180.438 Lamba-cyhalothrin and an isomer gamma-cyhalothrin; tolerances for residues.

(a)* * * * *

(2)* * * Commodity Parts per million * * * * * Okra 0.20 * * * * * Pistachio 0.05 * * * * *

(3)A tolerance of 0.01 part per million is established for residues of the insecticide lamba-cyhalothrin and an isomer gamma-cyhalothrin in or on all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food-handling establishments where food products are held, processed, or prepared. [FR Doc. E8-15518 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0571; FRL-8372-2] Ammonium Soap Salts of Higher Fatty Acids (C 8- C 18 saturated; C 8- C 12 ) unsaturated; 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 the ammonium soap salts of higher fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) in or on all food commodities when applied for the suppression and control of a wide variety of grasses and weeds. Falcon Lab, LLC 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 ammonium soap salts of higher fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated). DATES: This regulation is effective July 9, 2008. Objections and requests for hearings must be received on or before September 8, 2008, 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-2007-0571. 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: Raderrio Wilkins, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-1259; e-mail address: *wilkins.raderrio@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). • 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 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 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-2007-0571 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 September 8, 2008. 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-2007-0571, 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 August 8, 2007 (72 FR 44521) (FRL-8139-7), 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 7F7186) by Falcon Lab, LLC, 1103 Norbee Drive, Wilmington, DE 19803. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of ammonium soap salts of higher fatty acids (C 8- C 18 saturated and C 8- C 12 unsaturated). This notice failed to include a summary of the petition prepared by the petitioner Falcon Lab, LLC, nor was a summary of the petition provided in the docket for this action. Therefore, EPA republished notice of receipt of this petition in the **Federal Register** of April 16, 2008 (73 FR 20631) (FRL-8360-1), and posted the summary of the petition in the docket for this action. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the 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. Ammonium soap salts of fatty acids are one class of salts of fatty acids. Soaps are mineral salts of naturally occurring fatty acids. The fatty acids are a significant part of the normal daily diet, for they occur in dietary lipids which usually constitute about 90 grams in a day's diet. As discussed in this Unit, as part of the reregistration process, the Agency has already conducted a risk assessment for soap salts of fatty acids for their potential effects to human health and the environment and determined that all registered pesticide products containing the active ingredient Soap Salts are not likely to cause unreasonable adverse effects in people or the environment and were eligible for reregistration. The Agency issued a Reregistration Eligibility Document

(RED)in September 1992 for potassium salts of fatty acids (C 12- C 18 saturated and C 18 unsaturated, including potassium laureate, potassium myristate, potassium oleate, and potassium ricinoleate (CAS No. 10124-65-9) and ammonium salts of fatty acids (C 8- C 18 saturated and C 18 unsaturated, including ammonium oleate (CAS No. 84776-33-0). While the RED does not specifically identify the active ingredient ammonium nonanoate (also called pelargonic acid) by name, the Agency believes the conclusions of the RED are applicable to ammonium nonanoate because the RED defines the soap salts of fatty acids that were assessed to be (C 8- C 18 ) and ammonium nonanoate (pelargonic acid) is an ammonium salt of C 9 fatty acid. All soap salts with fatty acids having aliphatic carbon chains lengths in the range between C 8 and C 18 saturated and C 8- C 12 unsaturated are virtually identical in regard to chemistry and toxicology. In support of the RED, the Agency conducted a risk assessment for soap salts for their potential effects (if any) to human health. The Agency determined that soap salts of fatty acids are metabolized, forming simple compounds that serve as energy sources and structural compounds used in all living cells, and have low acute toxicity by the oral route of exposure. The RED notes that soap salts of potassium salts of coco fatty acid and sodium salts of caprylic acid, when administered to lab animals at high doses cause reproductive and mutagenic effects. However, based on the low toxicity of ammonium nonanoate and data/information reviewed in support of the tolerance exemption for pelargonic acid (ammonium nonanoate acid) which demonstrated that pelargonic acid did not cause developmental or mutagenic effects, the Agency believes that there would likely not be any reproductive or mutagenic effects for this active ingredient when used in the manner as described in this rule. Further the pesticidal concentration of ammonium nonanoate will be exceedingly lower in comparison to those high doses which were administered in the studies using potassium salts of coco fatty acids. The active ingredient ammonium soap salts of fatty acids, is used as a contact, non-selective, broad spectrum, foliar-applied herbicides. This active ingredient was federally registered in 2006 as a non-food use pesticide for the suppression and control of a wide variety of undesirable grasses and weeds. In addition, ammonium salts of fatty acids have been registered for other non-food uses, including repelling rabbits and deer from forage and grain crops, vegetables and field crops, in orchards, and on nursery stock, ornamentals, flower, lawns, turfs, vines, shrubs and trees. As part of this rulemaking, EPA reviewed the Soap Salts of Fatty Acid RED, the Pelargonic Acid Tolerance Exemption (40 CFR 180.1159), the data and/or information submitted by the petitioner and has concluded that ammonium nonanoate, a C 9 ammonium salt fatty acid (also called pelargonic acid) and other ammonium soap salts of higher fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) do not pose an unreasonable adverse effect to the environment, when used in accordance with approved labeling. While this pesticide is not intended to be sprayed directly on food or feed crops, the Agency has determined that there may be a potential for exposure from residues of ammonium soap salts on food and feed as a result of unintentional spray or drift. In lieu of submitting new Tier I toxicity studies for ammonium nonanoate, the registrant relied on data previously submitted in support of the Soap Salts Registration Eligibility Document (RED). The RED concluded that fatty acids such as oleic acids and related C 12- C 18 fatty acids are generally considered to be low toxicity by the oral route of exposure and gives a category IV for both oral and dermal route of exposure. This conclusion can be extended to all ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) because of the virtual identical chemistry and toxicology of these fatty acids. In addition to relying on the RED, the petitioner submitted requests for waiver of additional studies in support of its petition for a tolerance exemption. 1. *Acute inhalation toxicity* : Ammonium salts of fatty acids do not form aerosol particulates, have a vapor pressure near that of water and do not readily vaporize. “In a study in which 10 rats were exposed for 8 hours to saturated vapors of mixed isomers of decanoic acid (C 10 ) no deaths were observed.” MRID 43843503 reported that the LC 50 was > 1.244 milligrams/liter (mg/L) for nonanoic acid (C 9 ). 2. *Subchronic oral toxicity* : MRID 43843507 reported that no significant effects were demonstrated in a 14-day range finding study in rats given nonanoic acid at doses up to 1,834 mg/kilogram (kg)/day. “The agency concluded that a 90-day oral toxicity study was not necessary for a dietary risk assessment” of nonanoic acid due to the following: i. Lack of effects at extremely high doses in the range finding study; ii. Nature of nonanoic acid (a fatty acid) and its ubiquity in nature; iii. The results from acute mammalian toxicology studies; and iv. The unlikelihood of prolonged human exposure via the oral route due to the proposed use patterns. Dietary exposure would be minimized via plant metabolism of ammonium nonanoic acid through oxidative pathways common for fatty acids. The same rationale can be applied to ammonium salts of fatty acids because they share a chemical identity with ammonium nonanoic acid. 3. *Teratogenicity* : MRID 43843508, a developmental toxicity study of nonanoic acid (C 9 fatty acid), reported that the treatment had no adverse effects on clinical signs, body weight, or food/water consumption. No fetal toxicity was observed. The mean number of viable fetuses, early or late resorptions, implantation sites, corpora lutea, pre- and post-implantation losses, sex ratios and fetal body weight were comparable to those of the control group. The no observed adverse effect level (NOAEL) for maternal and developmental toxicity was 1,500 mg/kg/day and the lowest observed adverse effect level (LOAEL) was > 1,500 mg/kg/day. The developmental toxicity study for ammonium nonanoic acid showed no effects at dose levels above the limit dose (1,000 mg/kg/day). Therefore, the tier 1 data requirement for food use for this biochemical pesticide is satisfied. The same rationale can be applied to ammonium salts of fatty acids because they share a chemical identity with ammonium nonanoic acid. 4. *Immune response* : This study is conditionally required when there is a requirement for a sub-chronic oral, dermal, or inhalation study, depending on the most likely routes of exposure. The registrant requested waivers based on the factors given for the waiver request of the 90-day oral toxicity study. 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). Aggregate exposure to ammonium salts may occur via oral and dermal routes. Since the acute oral toxicity of soap salts is low (Toxicity Category IV), the risks anticipated from oral exposures are considered minimal. The acute dermal toxicity is also low (Toxicity Category IV). Longer dermal exposures can produce mild to moderate irritation, but soap salts are not skin sensitizers. As a result, the anticipated risks from dermal exposure are considered minimal. Since the inhalation route is not a likely exposure pathway the anticipated risk from inhalation exposure are also considered minimal. A. Dietary Exposure 1. *Food* . Pesticides containing ammonium soap salts of fatty acids are likely to be used as contact, non-selective, broad spectrum, foliar-applied herbicides or as repellents. As such they are likely not to be applied directly to any food plants. Moreover, ammonium salts of fatty acids are expected to be rapidly metabolized by soil microorganisms, with a half-life of perhaps less than one day, therefore residues of ammonium salts of fatty acids when used in accordance with approved labeling will not persist in the environment. The lack of direct application to food plants coupled with the rapid metabolization of ammonium salts when used as pesticides will result in low exposures to ammonium soap salts of fatty acids. However, if the exposures to ammonium soap salts to humans from food commodities that have been indirectly sprayed with residues of ammonium salts occur, the Agency does not expect exposures to be unsafe due the low acute toxicity and likely low exposure of these soap salts. 2. *Drinking water exposure* . No significant exposure to drinking water is expected from an accumulation of soap salts in the aquatic environment when it is used in accordance with approved labeling. Ammonium salts of fatty acids are not to be applied directly to water. B. Other Non-Occupational Exposure Non-occupational dermal exposure to ammonium salts of fatty acids will be expected since the use of this pesticide will be in the residential settings. However, the Agency believes that any hazard related to exposure to residential users from this pesticide will likely be insignificant. This belief is based on the fact that the toxicity data demonstrated no toxic endpoints upon which to base a risk characterization at or below 1,000 mg/kg of body weight/day (the limit dose). Non-occupational inhalation exposure is not expected because ammonium salts of fatty acids do not form aerosol particulates, have a vapor pressure near that of water, and do not readily vaporize. V. Cumulative Effects Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effect of exposure to residues that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Except for ocular exposure, ammonium nonanoate is of low toxicity, and it is not anticipated that there would be cumulative effects from common mechanisms of toxicity. Studies of fatty acids and fatty acid salts previously submitted to the Agency, indicate that the half-life of fatty acids is less than one

(1)day (MRID 00157476). As can be expected, there is very rapid microbial degradation of fatty acids in soil. Fatty acids and their salts are excellent substrates for microbial growth, serving both as carbon sources and energy sources. The active ingredient cannot totally dissipate from soil, because there is a natural content of fatty acids in soil resulting from plant metabolism and by formation of microbial organisms. Fatty acids constitute a significant portion of the normal daily diet of mammals (including humans, birds, and invertebrates since they are found in large amounts in the form of lipids in all living tissues (including seeds). Microbial metabolism of fatty acids has the effect of either converting the degradates to CO 2 and ester (if used as an energy source) or converting the carbon content of the fatty acid to any of the thousands of naturally occurring organic substances produced by the soil microflora (if used as a carbon source). Based on these known facts of the role of fatty acids in the environment and in food and feed, there should be no concern for cumulative effects of ammonium salts of fatty acids used as pesticides. VI. Determination of Safety for U.S. Population, Infants and Children There is a reasonable certainty that no harm to the U.S. population, including infants and children , will result from aggregate exposure to residues of ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) due to their use as a pesticide. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed in Unit III, ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) have low toxicity. Moreover, many soap salts of fatty acids are part of the human diet and pesticide exposures are not expected to exceed the levels of naturally occurring fatty acids in commonly eaten foods. Accordingly, exempting ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) from the requirement of a tolerance is considered safe. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure MOE (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 exposure (safety) will be safe for infants and children. Margins of exposure are often referred to as uncertainty or safety factors. In this instance, based on all available information, the Agency concludes that ammonium salts of fatty acids are practically non-toxic to mammals including infants and children. Because there are no threshold effects of concern to infants, children, and adults when ammonium salt is used as labeled, the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. As a result, EPA has not used a MOE approach to assess the safety of ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated). VII. Other Considerations A. Endocrine Disruptors EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate”. Ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) are not known endocrine disruptors nor are they related to any class of known endocrine disruptors. B. Analytical Method(s) There have been no analytical procedures conducted to ascertain residuals of ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated) on food crops that have been exposed to pesticides containing such ammonium salts of fatty acids. Naturally occurring fatty acids constitute a significant part of the normal daily diet and are of low toxicity when taken orally and pose no known health risks. Further, based on data and/or information already reviewed by the Agency in support of the reregistration of soap salts of fatty acids, the residues of these salts of fatty acids from pesticide use are not likely to exceed and are likely to be indistinguishable from levels of naturally occurring fatty acids in commonly eaten foods. C. Codex Maximum Residue Level There are currently no established Codex, Canadian, or Mexican MRLs for ammonium salts of fatty acids in/on plants or livestock commodities. Therefore, no compatibility issues exist with regard to the proposed U.S. exemption from the requirement of a tolerance. VIII. Conclusions There is currently no tolerance or tolerance exemption for ammonium salts of fatty acids. A proposed rule was published on May 1, 1996 (61 FR 19233) (FRL-5362-9), to exempt ammonium oleate and related C 8- C 18 fatty acids ammonium salts from the requirement of a tolerance for residues in or on all raw agricultural commodities when used in accordance with good agricultural practice; however, the proposed rule was never finalized by the Agency. This action will formalize food use approval for ammonium salts of fatty acids as stated in the 1992 RED: Soap Salts, by exempting ammonium salts of higher fatty acids from the requirement of a tolerance. The Agency has determined that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children from aggregate exposures to residues of ammonium salts of fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated). This conclusion is based on the demonstrated, very low acute oral and dermal toxicity of these ammonium salts and because the Agency anticipates that actual exposures in food will be low due to the uses of ammonium soap salts of fatty acids. IX. 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 final rule has been exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition, this final 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). X. 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: June 30, 2008. Debra Edwards, Director, 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 180.1284 is added to subpart D to read as follows: § 180.1284 Ammonium salts of higher fatty acids (C 8- C 18 saturated; C 8- C 12 unsaturated); exemption from the requirement of a tolerance. This regulation establishes an exemption from the requirement of a tolerance for residues of the ammonium salts of higher fatty acids C 8- C 18 saturated; C 8- C 12 unsaturated on in or on all food commodities when applied for the suppression and control of a wide variety of grasses and weeds. [FR Doc. E8-15516 Filed 7-8-08; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket Nos. 06-121, 02-277, 04-228, MM Docket Nos. 01-235, 01-317, 00-244, 99-360; FCC 07-216] 2006 Quadrennial Regulatory Review—Review of the Commission's Broadcast Ownership Rules and Other Rules Adopted Pursuant to Section 202 of the Telecommunications Act of 1996 AGENCY: Federal Communications Commission. ACTION: Final rule; announcement of effective date. SUMMARY: This document announces the effective date of the rule change to section 73.3555(d) of the Commission's rules, which was published in the **Federal Register** on February 21, 2008. The rule relates to the cross-ownership of broadcast stations and newspapers within a designated market area. DATES: The final rule published on February 21, 2008 (73 FR 9481), modifying 47 CFR 73.3555(d), is effective July 9, 2008. FOR FURTHER INFORMATION CONTACT: For additional information on this proceeding, contact Mania Baghdadi, *Mania.Baghdadi@fcc.gov* , 202-418-2330, of the Media Bureau, Industry Analysis Division. SUPPLEMENTARY INFORMATION: In a Report and Order and Order on Reconsideration released on February 4, 2008, FCC 07-216, and published in the **Federal Register** on February 21, 2008, 73 FR 9481, the Federal Communications Commission adopted a new rule which contains information collection requirements subject to the Paperwork Reduction Act. The Report and Order and Order on Reconsideration stated that the rule change requiring OMB approval would become effective immediately upon announcement in the **Federal Register** of OMB approval. On June 23, 2008, the Office of Management and Budget

(OMB)approved the information collection requirements contained in 47 CFR 73.3555(d). These information collections are assigned OMB Control Nos. 3060-0031 and 3060-0110. This publication satisfies the statement that the Commission would publish a document announcing the effective date of the rule change requiring OMB approval. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a valid OMB Control Number. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, 44 U.S.C. 3507. Broadcast licensees are reminded that, as enumerated in paragraph 78 of the Report and Order and Order on Reconsideration, licensees with a pending waiver request that involves an existing station combination consisting of more than one newspaper and/or more than one broadcast station will have 90 days after the changes to 47 CFR 73.3555(d) become effective to either amend their renewal or waiver requests or file a request for a permanent waiver. Entities that have been granted a temporary waiver of the newspaper/broadcast cross-ownership rule pending the completion of this rulemaking will have 90 days after the changes to 47 CFR 73.3555(d) become effective to either amend their renewal or waiver requests or file a request for a permanent waiver. See 73 FR at 9483, 9487. Federal Communications Commission. William F. Caton, Deputy Secretary. [FR Doc. E8-15594 Filed 7-8-08; 8:45 am] BILLING CODE 6712-01-P 73 132 Wednesday, July 9, 2008 Proposed Rules PEACE CORPS 22 CFR Part 304 RIN 0420-AA23 Claims Against the Government Under the Federal Tort Claims Act AGENCY: Peace Corps. ACTION: Proposed rule. SUMMARY: The Peace Corps proposes to revise its regulation concerning claims filed under the Federal Tort Claims Act, to make the regulation internally consistent with another provision stating that the Chief Financial Officer has authority to approve claims for amounts under $5000. DATES: Comments must be received by August 8, 2008. ADDRESSES: You may submit comments by e-mail to *sglasow@peacecorps.gov.* Include RIN 0420-AA23 in the subject line of the message. You may also submit comments by mail to Suzanne Glasow, Office of the General Counsel, Peace Corps, Suite 8200, 1111 20th Street, NW., Washington, DC 20526. Contact Suzanne Glasow for copies of comments. FOR FURTHER INFORMATION CONTACT: Suzanne Glasow, Associate General Counsel, 202-692-2150, *sglasow@peacecorps.gov.* SUPPLEMENTARY INFORMATION: On March 16, 2007, Peace Corps revised section 22 CFR § 304.7 to provide that the Chief Financial Officer “has the authority to adjust, determine, compromise, and settle claims for less than $5,000.” This proposed revision would rectify an omission in § 304.10, which does not currently refer to the Chief Financial Officer's authority for deciding claims worth less than $5,000. On April 22, 2008, the Peace Corps published a direct final rule that revised part 304.10. The Peace Corps received one comment within the comment period. As a result, the Peace Corps is republishing this revision to the regulation as a proposed rule. Section-by-Section Analysis Section 304.10 Subpart

(b)is amended to reflect the fact that the Chief Financial Officer will make final determinations for claims worth less than $5,000. Executive Order 12866 This regulation has been determined to be non-significant within the meaning of Executive Order 12866. Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)) This regulatory action will not have a significant adverse impact on a substantial number of small entities. Unfunded Mandates Act of 1995 (Sec. 202, Pub. L. 104-4) This regulatory action does not contain a Federal mandate that will result in the expenditure by state, local, and tribal governments, in aggregate, or by the private sector of $100 million or more in any one year. Paperwork Reduction Act of 1995 (44 U.S.C., Chapter 35) This regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act. Federalism (Executive Order 13132) This regulatory action does not have Federalism implications, as set forth in Executive Order 13132. It will not 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. List of Subjects in 22 CFR Part 304 Claims. Accordingly, Peace Corps proposes to amend 22 CFR part 304 as follows: PART 304—CLAIMS AGAINST THE GOVERNMENT UNDER THE FEDERAL TORT CLAIMS ACT 1. The authority citation for part 304 continues to read as follows: Authority: 28 U.S.C. 2672; 22 U.S.C. 2503(b); E.O. 12137, as amended. 2. Amend § 304.10 to revise paragraph

(b)to read as follows: § 304.10 Review of claim.

(b)After legal review and recommendation by the General Counsel, the Director of the Peace Corps will make a written determination on the claim, unless the claim is worth less than $5,000, in which case the Chief Financial Officer will make the written determination. Dated: July 1, 2008. Tyler Posey, General Counsel. [FR Doc. E8-15583 Filed 7-8-08; 8:45 am] BILLING CODE 6015-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-146895-05] RIN 1545-BF05 Election to Expense Certain Refineries AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed rulemaking by cross-reference to temporary regulations and notice of public hearing. SUMMARY: In the Rules and Regulations section of this issue of the **Federal Register** , the IRS is issuing temporary regulations relating to the election to expense qualified refinery property under section 179C of the Internal Revenue Code

(Code)and affects taxpayers who own refineries located in the United States. The temporary regulations reflect changes to the law by the Energy Policy Act of 2005. The text of those regulations also serves as the text of these proposed regulations. This document also provides notice of a public hearing. DATES: Written or electronic comments must be received by September 8, 2008. Outlines of the topics to be discussed at the public hearing scheduled for Thursday, November 20, 2008, at 10 a.m. must be received by Tuesday, October 14, 2008. ADDRESSES: Send submissions to: CC:PA:LPD:PR (REG-146895-05), room 5203, Internal Revenue Service, PO Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-146895-05), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224. Alternatively, taxpayers may submit electronic comments via the Federal eRulemaking Portal at *www.regulations.gov* (IRS-REG-146895-05). FOR FURTHER INFORMATION CONTACT: Concerning the proposed regulations, Philip Tiegerman at

(202)622-3110; concerning submissions of comments, hearing, and/or to be placed on the building access list to attend the hearing, Oluwafunmilayo Taylor at

(202)622-7180 (not toll-free numbers). SUPPLEMENTARY INFORMATION: Paperwork Reduction Act The collections of information contained in this notice of proposed rulemaking have been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collections of information should be sent to the Office of Management and Budget, Attn: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies to the Internal Revenue Service, Attn: IRS Reports Clearance Officer, SE:W:CAR:MP:T:T:SP, Washington, DC 20224. Comments on the collection of information should be received by September 8, 2008. Comments are specifically requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Internal Revenue Service, including whether the information will have practical utility; The accuracy of the estimated burden associated with the proposed collection of information; How the quality, utility, and clarity of the information to be collected may be enhanced; How the burden of complying with the proposed collections of information may be minimized, including through the application of automated collection techniques or other forms of information technology; and Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of service to provide information. The collection of information in this proposed regulation is in § 1.179C-1T(d)(2), § 1.179C-1T(d)(3), § 1.179C-1T(e)(2), and § 1.179C-1T(f). The collections of information in § 1.179C-1T(d)(2) and § 1.179C-1T(f) are required in order for a taxpayer to make and support an election under section 179C(a) to expense 50 percent of the cost of qualified refinery property. The collection of information in § 1.179C-1T(d)(3) is required in order for the taxpayer to revoke an election under section 179C(a). The collection of information in § 1.179C-1T(e)(2) is required in order for a taxpayer that is an organization described in section 1381 that has made an election under section 179C(a) to allocate all or a portion of this expense to its owners that are organizations described in section 1381. The collection of information is mandatory. The likely recordkeepers are owners of certain existing refineries. *Estimated total annual recordkeeping burden:* 120 hours. The estimated annual burden per recordkeeper varies depending on individual circumstances, with an estimated average of 10 hours. *Estimated number of recordkeepers:* 12. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. Background and Explanation of Provision The temporary regulations in the Rules and Regulations section of this issue of the **Federal Register** amend the Income Tax Regulations (26 CFR part 1) relating to section 179C. The temporary regulations define “qualified refinery property” and assist the taxpayer in identifying those costs that may be expensed pursuant to this provision. The text of those regulations also serves as the text of these proposed regulations. The preamble to the temporary regulations explains the amendments. Special Analyses It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. The collections of information in § 1.179-1T (d)(2), (e)(2) and

(f)are required by section 179C(b),

(g)and (h), respectively, and, therefore, are not imposed by these regulations. Accordingly, they are not subject to the Regulatory Flexibility Act. Only the collection of information in § 1.179-1T(d)(3), regarding the revocation of an election under section 179C(a), is imposed by these regulations. It is hereby certified that the collection of information contained in § 1.179-1T(d)(3) of the regulations will not have a significant economic impact on a substantial number of small entities. This certification is based upon the fact that although most of the 12 taxpayers who potentially could or would make an election under section 179C(a) will be small entities, it is expected that few, if any, of those 12 taxpayers once having made the election will choose to revoke it. Therefore, the collection of information will not affect a substantial number of small entities. The information required to revoke an election under section 179C(a) consists entirely of a portion of the information required to make the election. Consequently, the economic burden for those taxpayers who choose to revoke the election is minimal in nature and the regulations do not impose any burden in addition to the burden associated with making the election. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, this regulation has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Comments and Requests for a Public Hearing Before the proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight

(8)copies) or electronic comments that are submitted timely to the IRS. The IRS and Treasury Department specifically request comments on the clarity of the proposed rule and how it may be made easier to understand. All comments will be available for public inspection and copying. A public hearing has been scheduled for Thursday, November 20, 2008, beginning at 10 a.m. in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the Constitution Avenue entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the FOR FURTHER INFORMATION CONTACT section of this preamble. The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing must submit written comments or electronic comments by October 7, 2008 and an outline of the topics to be discussed and the time to be devoted to each topic (signed original and eight

(8)copies) by Tuesday, October 14, 2008. A period of 10 minutes will be allotted to each person for making comments. An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving outlines has passed. Copies of the agenda will be available free of charge at the hearing. Drafting Information The principal author of these regulations is Philip Tiegerman of the Office of the Associate Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and Treasury Department participated in their development. List of Subjects in 26 CFR Part 1 Income taxes, Reporting and recordkeeping requirements. Proposed Amendments to the Regulations Accordingly, 26 CFR part 1 is proposed to be amended as follows: PART 1—INCOME TAXES **Paragraph 1** . The authority citation for part 1 is amended by adding an entry in numerical order to read as follows: Authority: 26 U.S.C. 7805 * * * Section 1.179C also issued under 26 U.S.C. 179C. * * * **Par. 2.** Section 1.179C-1 is added to read as follows: § 1.179C-1 Election to expense certain refineries. [The text of proposed § 1.79C-1 is the same as the text of § 1.179C-1T

(a)through

(g)published elsewhere in this issue of the **Federal Register** ]. Linda E. Stiff, Deputy Commissioner for Services and Enforcement. [FR Doc. 08-1424 Filed 7-3-08; 3:33 pm]

Proposed Rules. Final rule