Unknown. Final rule
16,147 words·~73 min read·
/register/2007/03/21/07-1386A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2007-03-21.xml --- 72 54 Wednesday, March 21, 2007 Contents Agricultural Agricultural Marketing Service PROPOSED RULES Milk marketing orders: Northeast et al., 13219 E7-5109 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Forest Service Animal Animal and Plant Health Inspection Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 13236-13237 E7-5108 Reports and guidance documents; availability, etc.:
Wildlife services; National Environmental Policy Act-related legal notices publication; Internet address and newspapers list, 13237-13238 E7-5110 Army Army Department See Engineers Corps Centers Centers for Disease Control and Prevention NOTICES Meetings: HIV and STD Prevention and Treatment Advisory Committee, 13288 07-1374 Coast Guard Coast Guard RULES Great Lakes pilotage regulations: Rate adjustments Correction, 13352-13353 Z7-3061 PROPOSED RULES Regattas and marine parades: 7th Annual Escape from Fort Delaware Triathlon, 13221-13224 E7-5144 Ocean City Maryland Offshore Challenge, 13219-13221 E7-5142 Commerce Commerce Department See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-5093 13239 E7-5095 CITA Committee for the Implementation of Textile Agreements NOTICES Textile and apparel categories:
Dominican Republic-Central America Free Trade Agreement; commercial availability— Fiber, yarn, or fabric, 13256-13264 E7-5102 Customs Customs and Border Protection Bureau NOTICES Commercial gauger and laboratory accreditations: Approval— Camin Cargo Control Inc., 13296-13297 E7-5098 Inspectorate America Corp., 13297 E7-5104 Petrospect, Inc., 13297 E7-5100 R. Markey & Sons, Inc., 13298 E7-5106 Thionville Surveying Co., Inc., 13297-13298 E7-5105 Tariff-rate quotas: Tuna, 13298 E7-5101 Defense Defense Department See Engineers Corps PROPOSED RULES Federal Acquisition Regulation (FAR):
Subcontractor award data, reporting requirements, 13234-13235 07-1318 Education Education Department NOTICES Grants and cooperative agreements; availability, etc.: Special education and rehabilitative services— Centers for Independent Living, 13264-13268 E7-5166 Energy Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission Energy Energy Efficiency and Renewable Energy Office NOTICES Consumer products; energy conservation program:
Representative average unit costs of energy sources— Electricity, natural gas, heating oil, propane, and kerosene, 13268-13269 E7-5141 Engineers Engineers Corps NOTICES Environmental statements; notice of intent: Brevard County, FL; Port Canaveral Improvements Section 203 Feasibility Study; correction, 13352 C7-1278 EPA Environmental Protection Agency RULES Air pollution control: Benzene and other mobile source air toxics emissions reduction; gasoline passenger vehicles, and portable gasoline containers controls Correction, 13352 Z7-2667 Pesticide programs:
Conventional pesticide products registration data requirements; Agriculture Secretary notification, 13167-13168 E7-5162 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: 6-benzyladenine, 13174-13179 07-1386 Spinosad, 13168-13174 E7-4760 Thifensulfuron methyl, 13179-13184 E7-4762 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: New Jersey, 13227-13229 E7-5157 NOTICES Agency information collection activities; proposals, submissions, and approvals, 13274-13277 E7-4925 E7-5160 Air pollution control:
State operating permits programs— Colorado, 13277 E7-5163 Pesticide, food, and feed additive petitions: Minrav Infrastructures
(1993)Ltd., et al., 13277-13279 E7-4933 Pesticides; experimental use permits, etc.: Monsanto Co., 13279-13280 E7-5027 Reports and guidance documents; availability, etc.: Non-antimicrobial residential/household use pesticide product labels; disposal instructions, 13280-13281 07-1291 Executive Executive Office of the President See Presidential Documents Federal Accounting Federal Accounting Standards Advisory Board NOTICES Meetings: Public hearing and 2007 and 2008 meeting schedule, 13281-13282 07-1383 FAA Federal Aviation Administration RULES High altitude reporting points, 13165 E7-5065 Standard instrument approach procedures, 13165-13167 E7-5092 NOTICES Meetings: RTCA, Inc., 13342-13343 07-1343 FCC Federal Communications Commission RULES Television broadcasting: Cable Communications Policy Act; implementation— Local franchising authority decisions; application filing requirement, 13189-13215 E7-5119 PROPOSED RULES Radio stations; table of assignments: Oregon, 13229-13230 E7-5073 Television broadcasting: Cable Communications Policy Act; implementation— Local franchising authority decisions; application filing requirement, 13230-13233 E7-5118 NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-5069 13282-13283 E7-5168 Common carrier services: Local exchange carriers price cap; CALLS Order reconsideration petitions, 13283-13284 E7-5078 Meetings: North American Numbering Council, 13284-13285 E7-5075 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation combined filings, 13271-13272 E7-5129 Hydroelectric applications, 13272-13274 E7-5125 Reports and guidance documents; availability, etc.: CPA certification statements, stockholders reports, transmission investment activity reports, and narrative descriptions; electronic filing guidelines, 13274 E7-5127 *Applications, hearings, determinations, etc.:* Geneva Roth Holding, LLC, 13269 E7-5123 Northern Natural Gas Co., 13269-13270 E7-5126 Old Trail Wind Farm, LLC, 13270 E7-5124 Southern Star Central Gas Pipeline, Inc., 13270-13271 E7-5122 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 13285 E7-5171 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 13310 07-1401 Federal Railroad Federal Railroad Administration NOTICES Meetings: Private highway-rail grade crossings safety, 13343-13344 E7-5143 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 13285 E7-5132 FTC Federal Trade Commission NOTICES Prohibited trade practices: Sony BMG Music Entertainment, 13286-13288 07-1403 Fish Fish and Wildlife Service RULES Endangered and threatened species: Critical habitat designations— Spikedace and loach minnow, 13356-13422 07-1218 NOTICES Agency information collection activities; proposals, submissions, and approvals, 13300-13301 E7-5076 Environmental statements; notice of intent: Buena Vista Lagoon Restoration Project, San Diego County, CA, 13301-13302 07-1373 Meetings: Lake Champlain Sea Lamprey Control Alternatives Workgroup, 13302-13303 E7-5140 Food Food and Drug Administration NOTICES Meetings: Medical Devices Advisory Committee, 13288-13289 E7-5152 Science Advisory Board, 13289 E7-5153 Forest Forest Service NOTICES Appealable decisions; legal notice: Intermountain Region, 13238-13239 07-1369 GSA General Services Administration PROPOSED RULES Federal Acquisition Regulation (FAR): Subcontractor award data, reporting requirements, 13234-13235 07-1318 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration Homeland Homeland Security Department See Coast Guard See Customs and Border Protection Bureau NOTICES Grants and cooperative agreements; availability, etc.: Firefighters Assistance Program, 13289-13296 07-1380 Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 13298-13300 E7-5164 E7-5165 Environmental statements; record of decision: Manhattan, New York, NY; World Trade Center memorial and redevelopment plan, 13300 E7-5096 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau See Minerals Management Service See National Park Service RULES Native American Graves Protection and Repatriation Act; implementation: Future applicability procedures, 13184-13189 E7-5113 International International Trade Administration NOTICES Antidumping: Floor-standing, metal-top ironing tables and parts from— China, 13239-13242 E7-5170 Frozen fish fillets from— Vietnam, 13242-13246 E7-5178 Reports and guidance documents; availability, etc.: Antidumping methodologies in proceedings involving non-market economy countries; surrogate country selection and separate rates, 13246-13249 E7-5169 Labor Labor Department See Labor Statistics Bureau MISSING FOR: Labor Statistics Bureau Labor Statistics Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 13308-13310 E7-5121 Land Land Management Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 13303-13306 07-1361 07-1362 07-1363 Meetings: Resource Advisory Councils— Northwest California, 13306 E7-5071 Oil and gas leases: Washington, 13306-13307 E7-5155 Minerals Minerals Management Service NOTICES Environmental statements; availability, etc.: Alternative Energy and Alternate Use Program; public hearings, 13307-13308 E7-5158 Mine Mine Safety and Health Federal Review Commission See Federal Mine Safety and Health Review Commission NASA National Aeronautics and Space Administration PROPOSED RULES Federal Acquisition Regulation (FAR): Subcontractor award data, reporting requirements, 13234-13235 07-1318 NOTICES Agency information collection activities; proposals, submissions, and approvals, 13310 E7-5103 National Highway National Highway Traffic Safety Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 13344-13347 07-1385 National Institute National Institute of Standards and Technology NOTICES Agency information collection activities; proposals, submissions, and approvals, 13249 E7-5097 NOAA National Oceanic and Atmospheric Administration RULES Fishery conservation and management: Alaska; fisheries of Exclusive Economic Zone— Gulf of Alaska groundfish; correction, 13217-13218 E7-5074 Pacific cod, 13215-13216 07-1381 Pollock, 13216 07-1382 NOTICES Agency information collection activities; proposals, submissions, and approvals, 13249-13250 E7-5094 Endangered and threatened species permit applications, determinations, etc., 13250-13251 E7-5174 Marine mammals: Incidental taking; authorization letter, etc.— Vandenberg Air Force Base, CA; 30th Space Wing, U.S. Air Force; rocket and missile launches; seals and sea lions, 13251-13253 E7-5072 Meetings: Pacific Fishery Management Council, 13253-13255 E7-5145 Scientific research permit applications, determinations, etc., 13255 E7-5173 National Park National Park Service PROPOSED RULES Special regulations: Golden Gate National Recreation Area Dog Management Negotiated Rulemaking Advisory Committee; meeting, 13224 07-1371 National Capital Region; parking violations, 13224-13227 E7-5112 NOTICES Concession contract negotiations: Statue of Liberty National Monument/Ellis Island, NY, 13308 07-1370 Nuclear Nuclear Regulatory Commission NOTICES Decommissioning plans; sites: Whittaker Waste and Slag Storage Area, Transfer, PA, 13310-13312 E7-5149 Meetings: Reactor Safeguards Advisory Committee, 13312-13313 E7-5151 Reports and guidance documents; availability, etc.: Material transaction and status reports; preparation and distribution instructions, 13313 E7-5150 Patent Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 13255-13256 E7-5137 Postal Postal Service NOTICES Meetings; Sunshine Act, 13314 07-1395 Presidential Presidential Documents PROCLAMATIONS *Special observances:* National Poison Prevention Week (Proc. 8113), 13163-13164 07-1413 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 13314 E7-5154 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 13314-13316 E7-5057 E7-5136 Meetings; Sunshine Act, 13316 E7-5131 Options Price Reporting Authority: Consolidated Options Last Sale Reports and Quotation Information; Reporting Plan; amendments, 13316-13319 E7-5086 E7-5087 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 13320-13322 E7-5059 Boston Stock Exchange, Inc., 13322-13324 E7-5115 Chicago Board Options Exchange, Inc., 13324-13325 E7-5116 NASDAQ Stock Market LLC, 13325-13331 E7-5058 E7-5084 E7-5088 E7-5089 National Securities Clearing Corp., 13331-13332 E7-5133 New York Stock Exchange LLC, 13319-13320 E7-5117 NYSE Arca, Inc., 13333-13337 E7-5085 OneChicago, LLC, 13337-13338 E7-5114 Philadelphia Stock Exchange, Inc., 13338-13340 E7-5060 SBA Small Business Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 13340 E7-5083 Disaster loan areas: Missouri, 13341 E7-5080 Grants and cooperative agreements; availability, etc.: CommunityExpress Pilot Program, 13341 E7-5138 Meetings: District and regional advisory councils— North Florida, 13341 E7-5081 *Applications, hearings, determinations, etc.:* Rustic Canyon Ventures SBIC, L.P., 13340-13341 E7-5082 Textile Textile Agreements Implementation Committee See Committee for the Implementation of Textile Agreements Transportation Transportation Department See Federal Aviation Administration See Federal Railroad Administration See National Highway Traffic Safety Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 13341-13342 E7-5146 E7-5147 Treasury Treasury Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 13347 E7-5172 Veterans Veterans Affairs Department NOTICES Privacy Act; systems of records, 13347-13351 E7-5135 Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 13356-13422 07-1218 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 54 Wednesday, March 21, 2007 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2007-27438; Airspace Docket No. 07-AAL-03] RIN 2120-AA66 Revocation of High Altitude Reporting Point; AK AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action removes the HERRY as an Alaskan high altitude reporting point. The FAA has determined that this reporting point should be removed from the National Airspace System (NAS), since the HERRY is no longer used as a high altitude reporting point. DATES: *Effective Date:* 0901 UTC, May 10, 2007. The Director of **Federal Register** approves this incorporation by reference action under 1 CFR part 51, subject the annual revision of FAA Order 7400.9 and publication of conforming amendments. FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace and Rules, Office of System Operations Airspace and Aeronautical Information Management, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:
(202)267-8783. SUPPLEMENTARY INFORMATION: Background In October 2006, it was determined that the HERRY high altitude reporting point was no longer required to support the NAS and is no longer used by the FAA. The Rule This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by revoking the HERRY high altitude reporting point. Accordingly, since this action only involves a change in the legal description, notice and public procedure under 5 U.S.C. 533(b) are unnecessary. Alaskan high altitude reporting points are published in paragraph 7005 of FAA Order 7400.9P dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The high altitude reporting points listed in this document will be removed subsequently in the Order. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under Department of Transportation
(DOT)Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, paragraph 311(a), “Environmental Impacts: Policies and Procedures”. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, is amended as follows: Paragraph 7005 Alaskan High Altitude Reporting Points. Herry, AK [Removed] Issued in Washington, DC on March 14, 2007. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E7-5065 Filed 3-20-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30542; Amdt. No. 3211] Standard Instrument Approach Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This amendment amends Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective March 21, 2007. The compliance date for each SIAP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of March 21, 2007. ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: *For Examination* — 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Ave, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which affected airport is located; or 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or, 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . *For Purchase* —Individual SIAP copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. *By Subscription* —Copies of all SIAPs, mailed once every 2 weeks, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. FOR FURTHER INFORMATION CONTACT: Donald P. Pate, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone:
(405)954-4164. SUPPLEMENTARY INFORMATION: This amendment to Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) amends Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in the appropriate FAA Form 8260, as modified by the the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), which is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Code of Federal Regulations. Materials incorporated by reference are available for examination or purchase as stated above. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the **Federal Register** expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs. The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days. Further, the SIAPs contained in this amendment are based on the criteria contained in TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on March 9, 2007. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, LDA w/GS, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, MLS, TLS, GLS, WAAS PA, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; § 97.35 COPTER SIAPs, § 97.37 Takeoff Minima and Obstacle Departure Procedures. Identified as follows: * * * Effective Upon Publication FDC date State E City Airport FDC No. Subject 02/23/07 OR PORTLAND PORTLAND INTL 7/3849 VOR/DME RWY 21, ORIG-B. 02/23/07 OR PORTLAND PORTLAND INTL 7/3850 VOR RWY 28R, AMDT 2A. 02/23/07 OR PORTLAND PORTLAND INTL 7/3851 ILS RWY 10R (CAT II), AMDT 32. 02/23/07 OR PORTLAND PORTLAND INTL 7/3852 ILS RWY 10R (CAT III), AMDT 32. 02/23/07 OR PORTLAND PORTLAND INTL 7/3853 LOC/DME RWY 21, AMDT 7B. 02/23/07 OR PORTLAND PORTLAND INTL 7/3854 ILS OR LOC RWY 10L, AMDT 2. 02/23/07 OR PORTLAND PORTLAND INTL 7/3855 ILS OR LOC RWY 10R, AMDT 32. 02/23/07 OR PORTLAND PORTLAND INTL 7/3856 VOR A, AMDT 9B. [FR Doc. E7-5092 Filed 3-20-07; 8:45 am] BILLING CODE 4910-13-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 158 [EPA-HQ-OPP-2004-0387; FRL-8112-6] RIN 2070-AC12 Pesticides; Data Requirements for Conventional Chemicals; Final rule; Notification to the Secretary of Agriculture AGENCY: Environmental Protection Agency (EPA). ACTION: Notification to the Secretary of Agriculture. SUMMARY: This document notifies the public that the Administrator of EPA has forwarded to the Secretary of Agriculture a draft final rule as required by section 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As described in the Agency's semi-annual Regulatory Agenda, the draft final rule updates the data requirements in 40 CFR part 158 for the registration of conventional pesticide products. Besides providing the regulated community with clearer and more transparent information, the updated data requirements will enhance the development of health and environmental data to conduct scientifically sound chemical/hazard risk assessments to protect human health and the environment. ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2004-0387. All documents in the docket are listed on the regulations.gov web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Vera Au, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-0001; telephone number: 703-308-9069; e-mail address: *au.vera@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. It simply announces the submission of a draft final rule to the U. S. Department of Agriculture
(USDA)and does not otherwise affect any specific entities. This action may, however, be of particular interest to a producer or registrant of a pesticide product, including agricultural, residential, and industrial, but not including antimicrobial pesticides, biochemical pesticides, or microbial pesticides. This action may also affect any person or company who might petition the Agency for new tolerances, hold a pesticide registration with existing tolerances, or any person or company who is interested in obtaining or retaining a tolerance in the absence of a registration, that is, an import tolerance. This latter group may include pesticide manufacturers or formulators, importers of food, grower groups, or any person or company who seeks a tolerance. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using 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* . II. What Action is EPA Taking? Section 25(a)(2) of FIFRA requires the Administrator to provide the Secretary of Agriculture with a copy of any final regulation at least 30 days before signing it for publication in the **Federal Register** . The draft final rule is not available to the public until after it has been signed by EPA. If the Secretary comments in writing regarding the draft final rule within 15 days after receiving it, the Administrator shall include the comments of the Secretary, if requested by the Secretary, and the Administrator's response to those comments in the final rule when published in the **Federal Register** . If the Secretary does not comment in writing within 15 days after receiving the draft final rule, the Administrator may sign the final rule for publication in the **Federal Register** anytime after the 15-day period. III. Do Any Statutory and Executive Order Reviews Apply to this Notification? No. This document is not a rule, it is merely a notification of submission to the Secretary of Agriculture. As such, none of the regulatory assessment requirements apply to this document. IV. Will this Notification be Subject to the Congressional Review Act? No. This action is not a rule for purposes of the Congressional Review Act (CRA), 5 U.S.C. 804(3), and will not be submitted to Congress and the Comptroller General. EPA will submit the final rule to Congress and the Comptroller General as required by the CRA. List of Subjects in 40 CFR Part 158 Environmental protection, Confidential business information, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 30, 2007. James Jones, Director, Office of Pesticide Programs. [FR Doc. E7-5162 Filed 3-20-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0579; FRL-8114-4] Spinosad; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes and amends tolerances for residues of spinosad in or on certain commodities. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective March 21, 2007. Objections and requests for hearings must be received on or before May 21, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0579. 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: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-7610; e-mail address: *jackson.sidney@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0579 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before May 21, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0579, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of July 14, 2006 (71 FR 40105) (FRL-8077-3), 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 6E7068 and 3E6802) by the IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.495 be amended by establishing a tolerance for residues of the insecticide spinosad, in or on hops at 22 parts per million
(ppm)(under PP 6E7068) and amaranth, grain, stover at 10 ppm; cattle, meat at 2 ppm; sheep, meat at 2 ppm; goat, meat at 2 ppm; horse, meat at 2 ppm; poultry, meat at 0.1 ppm; cattle, fat at 50 ppm; sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; and egg at 0.3 ppm (under PP 3E6802). Additionally, existing tolerances for meat byproducts which are currently based on residues in liver will be amended to establish separate liver tolerances and lower the meat byproducts tolerances which will now be based on residues in the kidney as follows: Cattle, meat byproducts, except liver at 5 ppm; sheep, meat byproducts, except liver at 5 ppm; goat, meat byproducts, except liver at 5 ppm; horse, meat byproducts, except liver at 5 ppm; poultry meat byproducts tolerance raised from 0.03 ppm and set at 0.1 ppm; cattle, liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at 10 ppm (under PP 3E6802). That notice referenced a summary of the petition prepared by Dow AgroScience, the registrant, that is available in the docket for this rulemaking. There were no comments received in response to the notice of filing. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* and *http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19357.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for residues of spinosad in or on hop, dried cones at 22 ppm; amaranth, grain, stover at 10 ppm; cattle, meat at 2.0 ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse, meat at 2.0 ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm; sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; poultry, fat at 1.30 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; and egg at 0.30 ppm. Additionally, existing tolerances for meat byproducts which are based on residues in liver will be amended to establish separate liver tolerances and lower the meat byproducts tolerances which will now be based on residues in the kidney as follows: Cattle, meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts, except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0 ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat byproducts tolerance raised from 0.03 ppm and set at 0.10 ppm; cattle, liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at 10 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 their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by spinosad 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 **Federal Register** of September 27, 2002 (67 FR 60923) (FRL-7199-5). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for spinosad used for human risk assessment can be found at *http://www.regulations.gov* in the following indices: 1. Docket ID number EPA-HQ-OPP-2006-0579, entitled *Application of Spinosad to Hops and as a Mosquito Larvicide* . Human Health Risk Assessment, dated August 2, 2006. 2. Docket ID number EPA-HQ-OPP-2005-0510, entitled *PPs 3E6699, 3E6780, and 4E6811. Application of Spinosad to Mint; Banana; Plantain; Peanut; Bulb Vegetables; Legume Vegetables; Forage, Fodder, and Straw of Cereal Grains (crop group 16); Grass Forage, Fodder, and Hay (crop group 17); and Nongrass Animal Feeds (crop group 18) and Application of Spinosad for Control of Fruit Flies* . HED Risk Assessment, dated September 15, 2005. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.495) for the residues of spinosad, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from spinosad 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. The Agency did not select a dose and endpoint for an acute dietary risk assessment due to the lack of toxicological effects of concern attributable to a single exposure
(dose)in studies available in the database including oral developmental toxicity studies in rats and rabbits. In the acute neurotoxicity study, the NOAEL was 2,000 milligrams/kilograms/day (mg/kg/day), highest dose tested. An acute dietary exposure assessment is not required. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ) version 2.03 (acute and cancer endpoints were not identified), which incorporates food consumption data as reported by respondents in the U.S. Department of Agriculture
(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The chronic dietary analyses assumed average/projected percent crop treated
(PPCT)estimates; projected percent head treated resulting from the dermal and premise treatments to ruminants, average field trial residues, and experimentally determined processing factors; and anticipated livestock residues. The chronic analysis assumed tolerance level residues for all crop, poultry, and egg commodities and anticipated residues for ruminant and milk commodities. iii. *Cancer* . Spinosad has been classified as not likely to be carcinogenic in humans based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, a quantitative cancer exposure assessment was not performed. iv. *Anticipated residue and percent crop treated
(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such data call-ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data call-ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Almond 5%; apple 30%; apricot 10%; avocado 5%; broccoli 40%; brussel sprout 15%; cabbage 30%; cantaloupes 10%; cauliflower 45%; celery 50%; cherry 25%; citrus 5%, excluding lemon, tangerine, and orange; collards 25%; corn, sweet 1%; cotton 5%; cucumber 20%; eggplant 15%; green, mustard 15%; green, turnip 5%; kale 30%; lemon 10%; lettuce 50%; nectarine 30%; orange 10%; peach 5%; pear 10%; pepper 35%; potato 5%; prune and plum 10%; spinach 30%; squash 10%; strawberry 35%; tangerine 10%; tomato 20%; and watermelon 5%. Exposure analysis also incorporated projected percent ruminant head treated resulting from the registered dermal and premise use (dairy cattle 23% and beef cattle 31%, actual data are not available despite this being a registered use) and projected PCT for alfalfa of 1%. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available Federal, State, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five except for those situations in which the average PCT is less than one. In those cases assumed not less than 1%, is used as the average and 2.5% is used the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available Federal, State, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five. In most cases, EPA uses available data from USDA/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent 6 years. EPA estimates PPCT for a new pesticide Use for use in chronic dietary risk assessment by assuming that the PCT during the pesticide's initial 5 years of use on a specific use site will not exceed the average PCT of the dominant pesticide (i.e., the market leader pesticide with the greatest PCT) on that site over the three most recent pesticide usage surveys. Comparisons are only made among pesticides of the same pesticide types (i.e., the dominant insecticide on the use site is selected for comparison with the new insecticide). The PCTs included in the average may be each for the same pesticide or for different pesticides since the same or different pesticides may dominate for each year selected. Typically, EPA uses data from the USDA/NASS as the source for the PCT data because they are publicly available. When a specific use site is not surveyed by USDA/NASS, EPA uses other data which may include proprietary data. The estimated PPCT, equivalent to the average PCT of the market leader is appropriate for use in the chronic dietary risk assessment. This method of estimating a PPCT for a new use of a registered pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. The predominant factors that bear on whether the estimated PPCT could be exceeded are whether the new pesticide use is more efficacious or controls a broader spectrum of pests than the dominant pesticides, whether there are concerns with pest pressure as indicated in emergency exemption requests or other readily available information, and/or other factors based on analysis of additional information. All information readily available has been considered for spinosad on dairy cattle, beef cattle and alfalfa, and it is the opinion of the Agency that it is unlikely that actual PCTs for spinosad on these sites will exceed the corresponding estimated PPCTs during the next 5 years. For cattle, the estimated PPCTs likely would not be exceeded because spinosad generally is more expensive than the leading alternative insecticides although it has efficacy on the same order for the targeted pests. For alfalfa, its estimated PPCT likely also would not be exceeded because it is considerably more expensive than the leading alternative, and treatments for the targeted pest, armyworms, have been relatively small on average over the past 8 years. The Agency believes that the three conditions listed in Unit III.C.1.iv. have been met. With respect to Condition 1, 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 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which spinosad may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for spinosad in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of spinosad. 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* . Typically, EPA evaluates the potential for human exposure to pesticides in drinking water through an assessment of available surface water and ground water monitoring data and modeling. For spinosad, no monitoring data were available for use in this drinking water assessment. Therefore, potential human exposures to spinosad were evaluated through modeling. Estimated exposure concentrations
(EECs)in surface water were calculated using Pesticide Root Zone Model/Exposure Analyses Modeling System (PRZM/EXAMS). Ground water concentrations were modeled using Screening Concentration in Ground Water (SCI-GROW) (version 2.3). Drinking water residues were then incorporated into the DEEM-FCID TM into the food categories “water, direct, all sources” and “water, indirect, all sources.” Available environmental fate data indicate that the spinosad transformation products maintain the basic ring structure of spinosad and that combined spinosad and its transformation products are stable. Therefore, the Agency concluded that a total residue method should be used when estimating spinsad residues in water, and that spinosad and its transformation products are stable under the aqueous photolysis, aerobic soil metabolism, and anaerobic aquatic metabolism conditions. Based on modeling results from surface water FQPA Index Reservoir Screening Tool (FIRST) and ground water SCI-GROW drinking water concentrations from application of spinosad to turf (4 x 0.4 pound active ingredient/acre (lb ai/acre); re-entry interval
(RTI)= 7 days; highest registered/proposed rate excluding the mosquito larvicide use): The EECs of spinosad for acute exposures are 34.5 parts per billion (ppb), 10.5 ppb for chronic exposures, and 1.1 ppb for ground water. The dietary exposure assessment assumed a water concentration of 10.5 ppb for all water sources (direct and indirect). Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). 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). Spinosad is currently registered for use on numerous crops with tolerances for combined residues of spinosad ranging from 0.01 to 200 ppm, as well as residential, non-dietary sites including turf and ornamentals to control a variety of worms, moths, flies, beetles, midges, thrips, leafminers, and fire ants. Granular (homeowner) and EC (commercial applicators) formulations are registered. No dermal endpoints were identified and based on the granular formulation and low-vapor pressure for spinosad, residential handler/applicator and post-application dermal/inhalation exposure assessments were not conducted. The Agency concluded that there is a potential for toddler short-term, non-dietary, oral exposures (hand-to-mouth, object-to-mouth, ingestion of granulars, and soil ingestion). Since EPA did not identify an acute dietary endpoint, episodic ingestion of granulars was not assessed. The Agency notes that the registered fruit fly bait application scenario permits application to non-crop vegetation and this use may result in residential exposures. Based on the application rates (fruit fly bait—0.0003 lb ai/acre and turf/ornamental—0.41 lbs ai/acre), EPA concludes that residential exposure resulting from the fruit fly application will be insignificant when compared to the exposure resulting from the turf/ornamental application. Therefore, quantitative analysis of the residential exposure resulting from the fruit fly bait application was not performed. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to spinosad and any other substances and spinosad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that spinosad has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no indication of increased susceptibility of rat and rabbit fetuses to *in utero* and/or postnatal exposure to spinosad. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicological database for spinosad is complete for FQPA assessment. ii. There is no evidence of increased susceptibility of rat or rabbit fetuses following *in utero* exposure in the developmental studies with spinosad, and there is no evidence of increased susceptibility of young rats in the reproduction study with spinosad. iii. There are no residual uncertainties identified in the exposure databases; the dietary food exposure assessment (chronic only; no acute endpoint was identified) is refined using anticipated residues calculated from field trial data and available PCT information. iv. EPA has indicated that the dietary drinking water exposure is based on conservative modeling estimates. v. EPA Residential Standard Operational Procedures
(SOPs)were used to assess post-application exposure to children as well as incidental oral exposure of toddlers, so these assessments do not underestimate the exposure and risks posed by spinosad. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, intermediate-, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . As there were no toxic effects attributable to a single dose, an endpoint of concern was not identified for the general population or to the subpopulation females 13-50 years old. No acute risk is expected from exposure to spinosad. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to spinosad from food and water will utilize 37% of the cPAD for the U.S. population, 32% of the cPAD for all infants less than a year old, and 86% of the cPAD for children 1-2 years old. Based on the use pattern, chronic residential exposure to residues of spinosad is not expected. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Spinosad is currently registered for uses (turf and ornamental application) that could result in short-term residential exposures (incidental oral exposures to toddlers). This incidental oral exposure is combined with chronic dietary (food and water) exposure for determination of aggregate short-term exposure. The Agency uses chronic dietary exposure when conducting short-term aggregate assessments as it has been determined this will more accurately reflect exposure from food than will acute exposure. Upon analyses of all available data, resulting aggregate MOEs are greater than or equal to 160. Therefore, the Agency concludes that short-term aggregate exposure to spinosad from food and residential uses is below the LOC. 4. *Aggregate cancer risk for U.S. population* . Spinosad has been classified as “not likely to be carcinogenic in humans” based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, spinosad is not expected to pose a cancer risk to humans. 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, and to infants and children from aggregate exposure to spinosad residues. IV. Other Considerations A. Analytical Enforcement Methodology There is a practical method; liquid chromatography mass spectroscopy-accelerated climate prediction initiative (LCMS-ACPI) for detecting and measuring levels of spinosad in or on food with a limit of detection (0.002 ppm) that allows monitoring of food with residues at or above the level set for these tolerances. The method has undergone successful EPA laboratory validation. Adequate enforcement methodology using high pressure liquid chromatography with ultraviolet detector (HPLC/UV) is available to enforce the tolerances in plants. Adequate livestock methods are available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an HPLC/UV method suitable for determination of spinosad residues in ruminant commodities. Method GRM 95.03 has undergone successful independent laboratory validation
(ILV)and EPA laboratory validation, and has been forwarded to the Food and Drug Administration
(FDA)for inclusion in PAM Volume II. Method GRM 95.15 is another HPLC/UV method suitable for determination of spinosad residues in poultry commodities. This method has been forwarded to FDA for inclusion in PAM Volume II. Method RES 95114, an immunoassay method for determination of spinosad residues in ruminant commodities, underwent a successful ILV and EPA laboratory validation. It has been submitted to FDA for inclusion in PAM Volume II. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits No Codex, Canadian, or Mexican maximum residue limits
(MRLs)have been established for residues of spinosad on the raw agricultural commodities associated with this action. V. Conclusion Therefore, tolerances are established for residues of spinosad. Spinosad is a fermentation product of *Saccharopolyspora spinosa* . The product consist of two selected active ingredients: Spinosyn A (Factor A: CAS# 131929-60-7) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS# 131929-63-0) or 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α *L* -manno-pyranosyl)oxy]-13-[[5(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on hop, dried cones at 22 ppm and amaranth, grain, stover at 10 ppm; cattle, meat at 2.0 ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse, meat at 2.0 ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm; sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; egg at 0.30 ppm; cattle, meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts, except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0 ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat byproducts tolerance raised from 0.03 ppm and set at 0.10 ppm; cattle, liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at 10 ppm. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to petitions 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 due to its lack of significance, 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). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this final rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This final rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this final rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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: March 5, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. The table in paragraph
(a)of § 180.495 is amended by: i. Alphabetically adding amaranth, grain, stover; cattle, liver; goat, liver; hop, dried cones; horse, liver; and sheep, liver. ii. Revising the remainder of the entries listed. The additions and revisions to the table in paragraph
(a)read as follows: § 180.495 Spinosad; tolerances for residues.
(a)* * * Commodity Parts per million Expiration/Revocation Date * * * * * Amaranth, grain, stover 10 None * * * * * Cattle, fat 50 None Cattle, liver 10 None Cattle, meat 2.0 None Cattle, meat byproducts, except liver 5.0 None * * * * * Egg 0.30 None * * * * * Goat, fat 50 None Goat, liver 10 None Goat, meat 2.0 None Goat, meat byproducts, except liver 5.0 None * * * * * Hop, dried cones 22 None Horse, fat 50 None Horse, liver 10 None Horse, meat 2.0 None Horse, meat byproducts, except liver 5.0 None * * * * * Milk 7.0 None Milk, fat 85 None * * * * * Poultry, fat 1.3 None Poultry, meat 0.10 None Poultry, meat byproducts 0.10 None * * * * * Sheep, fat 50 None Sheep, liver 10 None Sheep, meat 2.0 None Sheep, meat byproducts, except liver 5.0 None * * * * * [FR Doc. E7-4760 Filed 3-20-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0325; FRL-8117-9] 6-Benzyladenine; 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 biochemical pesticide, 6-benzyladenine (6-BA), in or on pear when applied/used as a plant regulator. Valent BioSciences Corporation (Valent) 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 6-benzyladenine. DATES: This regulation is effective March 21, 2007. Objections and requests for hearings must be received on or before May 21, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0325. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-8263; e-mail address: *greenway.denise@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0325 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before May 21, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0325, by one of the following methods. • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 19, 2006 (71 FR 20100) (FRL-8058-1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F7035) by Valent BioSciences Corporation (Valent), 870 Technology Way, Libertyville, IL 60048-6316. The petition requested that 40 CFR part 180 (specifically, § 180.1150) be amended by establishing an exemption from the requirement of a tolerance for residues of 6-benzyladenine (6-BA) in or on pear when applied at a rate of ≤182 grams of active ingredient per acre per season. The electronic docket (EPA-HQ-OPP-2006-0325) for this notice includes a summary of the petition prepared by the petitioner, Valent. Previously, on April 2, 2004 (69 FR 17304; FRL-7347-6), EPA issued a final rule granting a permanent exemption from the requirement of a tolerance for residues of 6-BA in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season, and the existing permanent tolerance exemption for apple was amended to expand the uses (by adding a post-bloom-applied stand-alone fruitlet thinner use) and increase the permissible application rate to ≤182 grams of active ingredient per acre per season. Both apple and the subject new crop, pear, are pome fruit and, therefore, botanically similar. The two crops are grown in the same climatic/geographic regions, and are similarly cultivated. For both crops, 6-BA is applied for the same purpose, on the same schedule, at the same application rate and with the same 86-day pre-harvest interval restriction. Based on these similarities, the Agency has determined for the purpose of establishing the requested tolerance exemption that previously-submitted and reviewed information and data supporting the current tolerance exemption for apple will apply equally to the new crop, pear. In submitting this petition, therefore, Valent is relying on information previously submitted in connection with seeking and obtaining the tolerance exemption for the expanded use of 6-BA on apple, which was summarized in the April 2, 2004, final rule, and also on new data summarized in the cited petition summary (i.e., PP 6F7035). New data submitted to the Agency by Valent on October 20, 2004 and summarized by the company in the current petition are a two-generation rat reproduction study, which is data not required for U.S. registration of this biochemical active ingredient, but rather was conducted to satisfy the registration requirements of other countries and submitted by the petitioner to augment the Agency's 6-BA data base. In response to EPA's April 19, 2006 notice, no comments were submitted in accordance with the instructions for submitting comments set forth in the notice. However, one informal comment was received from a private citizen who opposed issuance of a final rule. The commenter expressed concern regarding the hazard associated with plant regulator use in general, stated the unsupported belief that more testing needs to be done, and was generally opposed to the establishment of an exemption from the requirement of a tolerance as proposed in the subject pesticide tolerance petition for 6-BA. The Agency understands and recognizes that some individuals believe that pesticides, which include plant regulators, should be banned completely. Notwithstanding such beliefs, pursuant to its authority under the FFDCA, EPA has conducted a comprehensive assessment of 6-BA and has concluded that there is a reasonable certainty that no harm will result from dietary exposure to this chemical when its use is limited by the specified maximum application rates. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of the 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 the 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 the 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 the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicological profile for 6-BA was published by the Agency in the June 1994 N6-Benzyladenine (synonymous with the subject active ingredient, 6-benzyladenine) Reregistration Eligibility Decision
(RED)document ( *http://www.epa.gov/oppsrrd1/REDs/old_reds/n6benzyladenine.pdf* ). The summarized values and categories for the various, previously reviewed studies for the technical active ingredient are presented here. 1. *Acute toxicity* . Toxicity Category III was assigned to the acute oral toxicity study in the rat (lethal dose
(LD)<sup>50</sup> = 1.3 grams/kilogram (g/kg)), and in the eye irritation study in the rabbit (moderate irritant). Toxicity Category IV (the least toxic category) was assigned to the acute dermal toxicity study in the rabbit (LD <sup>50</sup> >5 g/kg), the acute inhalation toxicity study in the rat (lethal concentration
(LC)<sup>50</sup> = 5.2 milligrams/liter (mg/L)), and to the dermal irritation study in the rabbit (slight irritant). Additionally, from a dermal sensitization study in the guinea pig, it was determined that 6-BA is not a dermal sensitizer. There have been no reported incidents of hypersensitivity directly linked to 6-BA. Nevertheless, to comply with section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), any incident of hypersensitivity associated with the use of this pesticide must be reported to the Agency. 2. *Genotoxicity* . From three mutagenicity studies (Ames test, mouse micronucleus assay, and unscheduled DNA synthesis assay in the rat), it was determined that 6-BA is not mutagenic. 3. *Developmental toxicity* . The no observed adverse effect levels (NOAEL) and the lowest observed adverse effect levels (LOAEL) for maternal and developmental toxicity in rats, respectively, were found to be 50 and 175 milligrams/kilogram body weight/day (mg/kg bwt/day), respectively. 4. *Subchronic toxicity* . For rats of both sexes, the NOAEL was approximately 111 mg/kg bwt/day and the LOAEL was approximately 304 mg/kg bwt/day. In addition to the previously reviewed studies discussed above, a two-generation rat reproduction study was relied upon by Valent to support the current petition to establish an exemption from the requirement of a tolerance for residues of 6-BA in or on pear. The lowest-LOAEL for parental systemic toxicity of technical 6-BA is 750 ppm (58.6-70.4 mg/kg bwt/day) and is based on reduced body weight and weight gain in F <sup>0</sup> and F <sup>1</sup> male rats 1 .The NOAEL is 400 ppm (31.5-37.5 mg/kg bwt/day) 1 . This systemic adult endpoint was used in the dietary risk assessment. Although the systemic endpoint is similar to that used in previous occupational risk assessments, the previous toxicological endpoint (40 mg/kg bwt/day) has been modified to more precisely reflect the composition of test diets, rat body weights, and food consumption estimates 1 . 1 USEPA. N6-Benzyladenine: Review of Information for an Exemption from the Requirement of a Tolerance. K. R. Carlson to D. Greenway; December 5, 2006. Because only systemic and no reproductive effects were observed, the LOAEL for reproductive toxicity of technical 6-BA in rats could not be determined. The NOAEL, therefore, is >1,500 ppm (115.7-144.2 mg/kg bwt/day for males and 133.0-139.2 mg/kg bwt/day for females), the highest dose tested 1 . The LOAEL for offspring toxicity of technical 6-BA in rats is 750 ppm (66.7-68.1 mg/kg bwt/day) and is based on decreased body weight and weight gain in F <sup>1</sup> and F <sup>2</sup> male and female pups. The NOAEL is 400 ppm (35.8-36.0 mg/kg bwt/day) 1 . Uncertainty factors for inter- and intra-species variation (10X each) and subchronic to chronic extrapolation
(3X)were used to modify the toxicity NOAEL. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the 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). A. Dietary Exposure 1. *Food* . Apple field trials yielded acceptable magnitude of the residue data. In apples, residues of 6-BA were consistently near the limit of quantitation (LOQ). However, the residue levels for processed commodities did not increase relative to those on the raw commodity, and were below the LOQ. The apple field data are adequate to support the tolerance exemption for pear, limited by a maximum application rate of ≤182 grams of active ingredient per acre per season, because of the shared physical, compositional and cultural characteristics of the two botanically similar pome fruits, which also are grown in the same climatic/geographic regions. The proposed use pattern; low application rate, frequency and timing; and 86-day pre-harvest interval are identical for apple and pear. Because application precedes harvest by approximately 2.5 months for apple and pear, the potential for dietary exposure is reduced. Due to the low anticipated dietary intake of 6-BA residues relative to the chronic and acute population adjusted doses (see Unit VI.), and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was based on worst-case assumptions (such as conservatively assuming: That 100% of the crop is treated, that non-detected or <LOQ residue concentrations are present, and that chronic exposure from the few seasonal applications made 60-86 days before harvest could occur), it is highly unlikely that the proposed new use of 6-BA on pear will result in adverse effects to human health. 2. *Drinking water exposure* . The proposed use on pear is not expected to add potential exposure to residues of 6-BA in drinking water. Soil leaching studies have suggested that 6-BA is relatively immobile, adsorbing to sediment, and is degraded in the soil. Migration to potable water resources, therefore, is highly improbable. However, any residues that do reach surface waters from field runoff should quickly adsorb to sediment particles and be partitioned from the water column. 6-Benzyladenine also has low solubility in water, 76 ±2 mg/L at 20° C, and detections in ground water are not expected. Together, these data indicate that residues are not expected in drinking water. B. Other Non-Occupational Exposure The potential for non-dietary, non-occupational exposure to 6-BA residues for the general population, including infants and children, is unlikely because the uses, both those currently allowed and the one currently being established, are limited to applications in certain tree fruit and nut tree orchards. Additionally, because 6-BA is a naturally-occurring cytokinin plant regulator (having been detected in all higher plants tested for its presence), it is a normal part of the human diet. Moreover, the proposed use rates are well below the toxicity NOAELs (see Unit III.), and the residues resulting from applications made in accordance with the proposed use rates indicate dietary exposures that are <1.0% of the chronic and acute population adjusted doses. Therefore, not only is there a great likelihood of prior exposure for most, if not all, individuals to 6-BA, due to its natural presence in food crops, the data submitted also demonstrate that any incremental increased exposure due to the proposed use would be negligible due to the lack of residue in comparison with the toxicity NOAELs. V. Cumulative Effects 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.” These considerations include the possible cumulative effects of such residues on infants and children. EPA does not have, at this time, available data to suggest whether 6-BA has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to 6-BA and any other substances and 6-BA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that 6-BA has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's web site at *http://www.epa.gov/pesticides/cumulative/* . VI. Determination of Safety for U.S. Population, Infants and Children A. U.S. Population When assessing the contributions of apple and pistachio, the Agency's analysis estimated that the chronic exposures for the overall U.S. population was 0.000002 mg/kg/day (<1.0% of the chronic population adjusted dose (cPAD)) 1 . Similarly, the acute dietary estimated exposure was 0.000069 mg/kg/day (<1.0% of the acute population adjusted dose (aPAD)) for the overall U.S. population. Critical exposure commodity analysis showed that apple juice contributed the most to dietary exposure for the overall population. Dietary exposure to 6-BA residues in or on pear did not add significantly to the current dietary exposure to 6-BA from its use in or on apple or pistachio. Due to the low anticipated dietary intake of 6-BA residues relative to the chronic and acute population adjusted doses, and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was made based on worst-case assumptions (such as conservatively assuming: That 100% of the crop is treated, that non-detected or <LOQ residue concentrations are present, and that chronic exposure from the few seasonal applications made 60-86 days before harvest could occur), the Agency is reasonably certain that no dietary harm will result from aggregate exposure to 6-BA residues, including all anticipated dietary exposures (including the proposed new use of 6-BA on pear) and all other exposures for which there is reliable information. B. Infants and Children Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an additional ten-fold margin of exposure (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 (safety) are often referred to as uncertainty (safety) factors. In the case of 6-BA, the safety factor was reduced from 10X to 3X based on adequate data from a new 2-generation rat reproduction study, and from a rat developmental toxicity study, neither of which demonstrated unique fetal susceptibility (i.e., fetal or neonatal effects occurred only at maternally toxic doses) 1 . Additionally, genotoxicity and mutagenicity tests were negative. EPA did not reduce the uncertainty factor any further, however, because of the lack of a developmental toxicity study in a second species, and the resulting residual uncertainties for 6-BA-induced pre-/post-natal toxicity. The analysis estimated that the chronic exposures for the most highly exposed subgroup, non-nursing infants, was 0.000012 mg/kg/day (<1.0% of the cPAD). The acute dietary estimated exposure was 0.000361 mg/kg/day (<1.0% of aPAD) for the most highly exposed subgroup, non-nursing infants. Critical exposure commodity analysis showed that apple juice contributed the most to dietary exposure for all infants. Due to the low anticipated dietary intake of 6-BA residues relative to the chronic and acute PAD, and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was made based on worst-case assumptions (such as conservatively assuming: that 100% of the crop is treated, that non-detected or <LOQ residue concentrations are present, and that chronic exposure from the few seasonal applications made 60-86 days before harvest could occur), it is reasonably certain that no dietary harm will result to infants and children from aggregate exposure to residues of 6-BA resulting from all currently-registered uses, as well as from the proposed new use of 6-BA on pear. 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.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, 6-BA may be subjected to additional screening and/or testing to better characterize any possible effects related to endocrine disruption. Based on available data, no endocrine system-related effects have been identified with consumption of 6-BA. To date, there is no evidence to suggest that 6-BA affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor. B. Analytical Methods The Agency is establishing an exemption from the requirement of a tolerance for the reasons stated above. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purposes for 6-BA. Nonetheless, analytical methods for apple (a pome fruit botanically similar to the new crop, pear), both raw agricultural and processed commodities, and for pistachio have been developed and submitted by the registrant. The analytical method for apple is expected to be fully applicable (have the same sensitivity) to pear because the two pome fruits are physically and compositionally comparable, and therefore should present similar sequestration and matrix interference characteristics. C. Codex Maximum Residue Level Currently, there are no Codex, Canadian or Mexican maximum residue levels for residues of 6-BA in or on pear. VIII. Conclusions Based on the toxicology information submitted and reviewed previously and summarized in the June 1994 N6-Benzyladenine RED, in combination with the newly submitted two generation rat reproduction study and other information available to the Agency, there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of 6-BA under reasonably foreseeable circumstances, when 6-BA is used as a biochemical pesticide in accordance with its label and good agricultural practices. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the data submitted previously and summarized in the RED, as well as that data submitted to support this tolerance exemption, demonstrating negligible dietary exposure in comparison with the toxicity NOAELs. As a result, EPA is establishing an exemption (albeit, limited by a maximum application rate) from the tolerance requirements pursuant to section 408(c) and
(d)of the FFDCA for residues of 6-BA in or on pear. IX. Statutory and Executive Order Reviews This final rule establishes an exemption from the requirement of a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, * Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption from the requirement of a tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. X. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this 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: February 25, 2007. Janet L. Andersen, Director, Biopesticides and Pollution Prevention 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 180.1150 is revised to read as follows: § 180.1150 6-Benzyladenine; exemption from the requirement of a tolerance. The biochemical plant regulator 6-benzyladenine (6-BA) is exempt from the requirement of a tolerance in or on apple and pear when applied at a rate of ≤182 grams of active ingredient per acre per season, and in or on pistachio when applied at a rate of ≤60 grams of active ingredient per acre per season. [FR Doc. 07-1386 Filed 3-20-07; 8:45 am]
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register
U.S. Code
- Federal Aviation Administration§ 106
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Purposes§ 3501
- Establishment, functions, and activities§ 272
- Definitions§ 601
- SHORT TITLE.§ 801
- Definitions; generally§ 321
11 references not yet in our index
- 14 CFR 71
- 1 CFR 51
- 5 USC 533(b)
- 14 CFR 97
- 40 CFR 158
- 40 CFR 180
- 40 CFR 178
- 40 CFR 2
- 40 CFR 180.495
- Pub. L. 104-4
- Pub. L. 104-113
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