Unknown. Direct final rule
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/register/2007/08/29/07-4241A 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-2007-08-29.xml --- 72 167 Wednesday, August 29, 2007 Contents Agricultural Agricultural Marketing Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 49693-49694 07-4241 Grants and cooperative agreements; availability, etc.: Organic Certification Cost Share Program, 49694-49695 07-4242 Agriculture Agriculture Department See Agricultural Marketing Service See Forest Service See Rural Utilities Service Arts Arts and Humanities, National Foundation See National Foundation on the Arts and the Humanities Centers Centers for Disease Control and Prevention NOTICES Meetings:
National Center for Health Statistics— Scientific Counselors Board, 49722 E7-17137 Centers Centers for Medicare & Medicaid Services RULES Medicare: Home health prospective payment system; 2008 CY refinement and rate update, 49762-49945 07-4184 Coast Guard Coast Guard RULES Vessel documentation and measurement: Coastwise trade vessels; lease financing; reporting and recordkeeping requirements, 49666 E7-17075 Commerce Commerce Department See Foreign-Trade Zones Board See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration Defense Defense Department See Navy Department Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 49705-49706 E7-17056 Grants and cooperative agreements; availability, etc.:
Postsecondary education— Jacob K. Javits Fellowship Program, 49706-49708 E7-17143 Employee Employee Benefits Security Administration NOTICES Meetings: Employee Welfare and Pension Benefit Plans Advisory Council, E7-17050 E7-17051 49734-49735 E7-17052 E7-17053 Employment Employment and Training Administration NOTICES Adjustment assistance; applications, determinations, etc.: Hershey Co., 49736 E7-17044 Hoover Precision Products, Inc., et al., 49735-49736 E7-17042 Intel Corp., 49736 E7-17045 Kimberly-Clark Corp.
Global Sales, 49736 E7-17041 Maxair, 49737 E7-17047 Rockwell Automation, 49737 E7-17046 Employment Employment Standards Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 49737-49738 E7-17049 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Flusilazole, 49654-49660 E7-17110 Flutriafol, 49660-49666 E7-17112 Propylene oxide, 49646-49651 E7-17010 Spinosad, 49651-49654 E7-16897 PROPOSED RULES Air quality implementation plans:
Preparation, adoption, and submittal— Increment modeling procedures refinement; prevention of significant deterioration new source review, 49678-49679 E7-17104 Air quality implementation plans; approval and promulgation; various States; air quality planning purposes; designation of areas: Georgia, 49679-49689 E7-17133 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Dibasic esters, 49689-49692 E7-17109 NOTICES Meetings: Local Government Advisory Committee et al., 49709 E7-17107 Scientific Counselors Board, 49709-49710 E7-17129 Pesticide registration, cancellation, etc.:
Fenoxaprop-p-ethyl and etofenprox, 49710-49712 E7-17111 Sodium carbonate; weak mineral bases, 49712-49714 E7-16806 Reports and guidance documents; availability, etc.: Coal combustion wastes disposal in landfills and surface impoundments; data availability, 49714-49719 E7-17138 Executive Executive Office of the President See Trade Representative, Office of United States FAA Federal Aviation Administration PROPOSED RULES Class E airspace, 49676-49678 E7-17068 NOTICES Advisory circulars; availability, etc.:
Electronic propeller control systems; policy statement, 49755-49756 07-4230 Meetings: Government/Industry Aeronautical Charting Forum, 49756 07-4229 National Parks Overflights Advisory Group Aviation Rulemaking Committee, 49756-49757 07-4231 FCC Federal Communications Commission RULES Common carrier services: Satellite communications— Broadcasting-satellite service; policies and service rules, 50000-50033 E7-16575 Radio stations; table of assignments: Colorado, 49666-49667 E7-17013 PROPOSED RULES Radio stations; table of assignments:
Arizona, 49692 E7-17014 NOTICES *Applications, hearings, determinations, etc.:* Able Radio Corp., et al., 49719-49720 E7-17029 FDIC Federal Deposit Insurance Corporation NOTICES Agency information collection activities; proposals, submissions, and approvals, 49720-49721 E7-16912 Federal Emergency Federal Emergency Management Agency NOTICES Agency information collection activities; proposals, submissions, and approvals, 49726-49727 E7-17083 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation combined filings, 49708-49709 E7-16970 Federal Highway Federal Highway Administration NOTICES Federal agency actions on proposed highways; judicial review claims:
Contra Costa County, CA; highway project, 49757-49758 E7-17071 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 49721 E7-17134 Ocean transportation intermediary licenses: Access Freight Forwarders, Inc. et al., 49721-49722 E7-17139 Jeepney Express et al., 49722 E7-17128 FTC Federal Trade Commission RULES Appliances, consumer; energy consumption and water use information in labeling and advertising: Energy efficiency labeling requirements, 49948-49997 07-4193 Fish Fish and Wildlife Service RULES Migratory bird hunting:
Alaska; 2007 subsistence harvest regulations; correction, 49667 E7-17132 Food Food and Drug Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 49722 E7-17094 Reports and guidance documents; availability, etc.: Pharmacogenomic data submission; industry guidance, 49722-49723 E7-17103 Scientific evaluation of health claims; evidence-based review system; correction, 49723-49724 E7-17038 Foreign Foreign Claims Settlement Commission NOTICES Privacy Act; systems of records, 49731-49732 E7-17093 Foreign Foreign-Trade Zones Board NOTICES *Applications, hearings, determinations, etc.:* Iowa SACMI USA, Ltd.; packaging and food-processing equipment manufacturing facility, 49699 E7-17116 Forest Forest Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 49695-49696 E7-17040 Environmental statements; notice of intent:
Ashley National Forest, UT, 49696-49697 07-4227 Health Health and Human Services Department See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health Health Health Resources and Services Administration NOTICES Reports and guidance documents; availability, etc.: Federally-funded health centers; HRSA draft policy documents; Internet availability, 49724 E7-17092 Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-17065 49727-49729 E7-17066 E7-17098 Homeless assistance; excess and surplus Federal properties, 49729 E7-17062 Industry Industry and Security Bureau NOTICES Export privileges, actions affecting:
Norsal Export Ltd., 49699-49700 07-4226 Spector, Norman, 49701-49702 07-4228 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau NOTICES Meetings: Invasive Species Advisory Committee, 49729 E7-17127 International International Trade Administration NOTICES Antidumping: Oil country tubular goods from— Mexico, 49702-49703 E7-17115 International International Trade Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 49730-49731 E7-17084 Import investigations:
Sucralose, sweeteners containing sucralose, and related intermediate compounds, 49731 E7-17085 Justice Justice Department See Foreign Claims Settlement Commission See Justice Programs Office Justice Justice Programs Office NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-17101 49732-49733 E7-17102 Labor Labor Department See Employee Benefits Security Administration See Employment and Training Administration See Employment Standards Administration NOTICES Meetings:
Job Corps Advisory Committee, 49733-49734 E7-17055 Land Land Management Bureau NOTICES Alaska native claims selection: Port Graham Corp., 49729-49730 E7-17124 Resource management plans, etc.: Pocatello Resource Area, ID, 49730 E7-17073 National Credit National Credit Union Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-17060 E7-17063 49738-49741 E7-17114 E7-17117 National Foundation National Foundation on the Arts and the Humanities NOTICES Meetings:
Humanities Panel, 49741-49742 E7-17099 NIH National Institutes of Health NOTICES Inventions, Government-owned; availability for licensing, 49724-49726 E7-16929 NOAA National Oceanic and Atmospheric Administration NOTICES Marine mammal permit applications, determinations, etc., 49703 E7-17131 Meetings: New England Fishery Management Council, 49703-49704 E7-17088 North Pacific Fishery Management Council, 49704 E7-17086 Pacific Fishery Management Council, 49704-49705 E7-17087 Navy Navy Department NOTICES Patent licenses; non-exclusive, exclusive, or partially exclusive:
Tessarae Inc., 49705 E7-17126 Nuclear Nuclear Regulatory Commission PROPOSED RULES Rulemaking petitions: Nevada, 49668-49669 E7-17106 NOTICES Meetings: Medical Uses of Isotopes Advisory Committee, 49744 E7-17091 Reactor Safeguards Advisory Committee, 49744 E7-17136 Meetings; Sunshine Act, 49744-49745 07-4256 *Applications, hearings, determinations, etc.:* Carolina Power & Light Co., 49742-49744 E7-17135 Office of U.S. Trade Office of United States Trade Representative See Trade Representative, Office of United States Postal Postal Regulatory Commission NOTICES Meetings;
Sunshine Act, 49746 07-4254 RUS Rural Utilities Service NOTICES Environmental statements; availability, etc.: Dry Fork Station and Hughes Transmission Project, WY, 49697-49698 E7-17048 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-17077 49746-49747 E7-17078 Consolidated Tape Association Plan; amendments, 49747-49748 E7-17080 Investment Company Act of 1940: Allianz RCM Global EcoTrends Fund, et al., 49748-49750 E7-17076 Self-regulatory organizations; proposed rule changes:
American Stock Exchange LLC, 49750-49752 E7-17082 Chicago Board Options Exchange, Inc., 49752-49753 E7-17079 International Securities Exchange, LLC, 49753-49755 E7-17081 SBA Small Business Administration RULES Small business size standards: North American Industry Classification System; adoption, 49639-49646 E7-17151 PROPOSED RULES Small business size standards: North American Industry Classification System; adoption, 49669-49676 E7-17150 NOTICES Meetings: Regulatory Fairness Boards— Region VII; hearing, 49755 E7-17096 Veterans Business Affairs Advisory Committee, 49755 E7-17089 State State Department NOTICES Grants and cooperative agreements; availability, etc.:
U.S.-Egypt collaborative projects in science and technology; correction, 49755 E7-17121 U.S.-Egypt junior scientists development visits; correction, 49755 E7-17120 Surface Surface Transportation Board NOTICES Railroad services abandonment: BNSF Railway Co., 49758 E7-16960 Trade Trade Representative, Office of United States NOTICES Reports and guidance documents; availability, etc.: Foreign Trade Barriers; National Trade Estimate Report, 49745-49746 E7-17118 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Surface Transportation Board Veterans Veterans Affairs Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 49758-49760 E7-17090 E7-17095 Meetings:
Veteran's Disability Benefits Commission, 49760 07-4239 Veterans’ Readjustment Advisory Committee, 49760 07-4238 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 49762-49945 07-4184 Part III Federal Trade Commission, 49948-49997 07-4193 Part IV Federal Communications Commission, 50000-50033 E7-16575 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. 72 167 Wednesday, August 29, 2007 Rules and Regulations SMALL BUSINESS ADMINISTRATION 13 CFR Part 121 RIN 3245-AF66 Small Business Size Standards; Adoption of 2007 North American Industry Classification System for Size Standards AGENCY:
Small Business Administration. ACTION: Direct final rule. SUMMARY: The U.S. Small Business Administration
(SBA)is amending its Small Business Size Regulations by incorporating the Office of Management and Budget's
(OMB)2007 modifications of the North American Industry Classification System (NAICS) in its table of small business size standards. These modifications are few in number and result in revisions to size standards for three industries and four activities within other industries. SBA believes that this rule is routine and non-controversial, and the Agency anticipates no significant adverse comment. If SBA receives a significant adverse comment, it will withdraw the rule. SBA is publishing concurrently in this issue of the **Federal Register** a proposed rule to achieve the same result, that is, to modify its Small Business Size Regulations as contemplated in this direct final rule. DATES: This rule is effective October 1, 2007, without further action, unless SBA receives a significant adverse comment by September 28, 2007. If SBA receives any significant adverse comments, the Agency will publish a timely withdrawal of this rule in the **Federal Register** . ADDRESSES: You may submit comments, identified by RIN: 3245-AF66, by any of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Mail, for paper, disk, or CD/ROM submissions:* Gary M. Jackson, Division Chief for Size Standards, 409 Third Street, SW., Mail Code 6530, Washington, DC 20416. • *Hand Delivery/Courier:* Gary M. Jackson, Division Chief for Size Standards, 409 Third Street, SW., Mail Code 6530, Washington, DC 20416. SBA will post all comments on *www.regulations.gov* . If you wish to submit confidential business information
(CBI)as defined in the User Notice at *www.Regulations.gov* , please submit the information to Carl J. Jordan, Office of Size Standards, 409 Third Street, SW., Mail Code 6530, Washington, DC 20416, or send an e-mail to *sizestandards@sba.gov* . Highlight the information that you consider to be CBI and explain why you believe SBA should hold this information as confidential. SBA will review the information and make the final determination of whether it will publish the information or not. FOR FURTHER INFORMATION CONTACT: Carl Jordan, Office of Size Standards, at
(202)205-6618 or *sizestandards@sba.gov* . SUPPLEMENTARY INFORMATION: SBA adopted the NAICS industry definitions as a basis for its table of small business size standards effective October 1, 2000, as a replacement to the discontinued Standard Industrial Classification
(SIC)System (65 FR 30836, May 15, 2000). Since that time, OMB has issued two updates modifying the NAICS. SBA incorporated OMB's first updated modifications, termed NAICS 2002 (66 FR 3825, January 16, 2001), in its table of size standards effective October 1, 2002 (67 FR 52597, August 13, 2002). OMB published its most recent updates, termed NAICS 2007, on May 16, 2006 (71 FR 28532). SBA is adopting those updated modifications in its table of small business size standards, as explained below. For complete information on the relationship between NAICS 2002 and NAICS 2007, please see the U.S. Bureau of the Census (Census Bureau) Web site at *http://www.census.gov/epcd/www/naicsdoc.htm#fedreg* . That Census Bureau Web site provides complete information on its establishment and implementation of NAICS 2007, including its notice of final action in the March 16, 2006 **Federal Register** . The Census Bureau also provides the following correspondence tables:
(1)2007 NAICS-US matched to 2002 NAICS-US; and
(2)2002 NAICS-US matched to 2007 NAICS-US. How SBA Arrived at the Size Standards for NAICS 2007 Industries On October 22, 1999, SBA published in the **Federal Register** (64 FR 57188) a proposed rule to establish a new table of small business size standards based on the NAICS. SBA developed guidelines to transition from the SIC System to NAICS. The guidelines were intended to minimize the impact of a new industry classification system on SBA's small business size standards. Table 1, below, lists those guidelines. SBA received no negative comments to the guidelines specified in the proposed rule. Because the guidelines produced the desired results and received public acceptance, SBA published a final rule on May 5, 2000 (65 FR 3825) (corrected on September 5, 2000, 65 FR 53533) establishing a new table of size standards based on NAICS without change from its proposed rule. For purposes of adopting NAICS 2007, SBA is applying the same guidelines in this direct final rule. Table 1 If the NAICS 2007 industry is composed of: The Size standard for the NAICS industry will be: 1. One NAICS 2002 industry or part of one NAICS 2002 industry The same size standard as for the NAICS 2002 industry or part. 2. More than one NAICS 2002 industry; parts of more than one NAICS 2002 industry; or one or more NAICS 2002 industry and part(s) of one or more NAICS 2002 industry, *and* they all have the same size standard The same size standard as for those NAICS 2002 industries or parts of NAICS 2002 industries. 3. More than one NAICS 2002 industry; parts of more than one NAICS 2002 industry; or one or more NAICS 2002 industry and part(s) of one or more NAICS 2002 industry, *and* they do not all have the same size standard The same size standard as for the NAICS 2002 industry or NAICS 2002 industry part(s) that most closely matches the economic activity described by the NAICS 2007 industry. 4. One or more parts of an NAICS 2002 industry for which SBA has established specific size standards (i.e., further segmented) The same size standard as for that specific NAICS 2002 industry part. 5. One or more NAICS 2002 industries and/or parts of NAICS 2002 industries that were categorized broadly under the NAICS system as Services, Retail Trade, Wholesale Trade or Manufacturing, but are now categorized differently under NAICS SBA will
(a)apply a size standard measure ( *e.g.* , number of employees, annual receipts) typical of the NAICS Sector; and
(b)apply the corresponding “anchor” size standard. The “anchor” size standards are $6.5 million (effective December 6, 2005) for Services and Retail Trade, 500 employees for Manufacturing and 100 employees for Wholesale Trade (except for Federal procurement programs, where the standard is 500 employees under the non-manufacturer rule). Additions to and Deletions From NAICS 2002 for NAICS 2007 It is important to note the following: 1. NAICS 2007 changes affect 59 NAICS 2002 industries. 2. One NAICS 2002 Subsector and 12 NAICS 2002 industries were eliminated and their activities reclassified in other more appropriate or new NAICS 2007 industries as listed in Table 2: Table 2 NAICS 2002 code NAICS 2002 industry description NAICS 339111 Laboratory Apparatus and Furniture Manufacturing. Subsector 516 Internet Publishing and Broadcasting. NAICS 516110 Internet Publishing and Broadcasting. NAICS 517211 Paging. NAICS 517212 Cellular and Other Wireless Telecommunications. NAICS 517310 Telecommunications Resellers. NAICS 517510 Cable and Other Program Distribution. NAICS 517910 Other Telecommunications. NAICS 518111 Internet Service Providers. NAICS 518112 Web Search Portals. NAICS 525930 Real Estate Investment Trusts. NAICS 541710 Research and Development in the Physical, Engineering, and Life Sciences. NAICS 561310 Employment Placement Agencies. 3. The following eight industries listed in Table 3 are new in NAICS 2007: Table 3 NAICS 2007 code NAICS 2007 industry description NAICS 517210 Wireless Telecommunications Carriers (except Satellite). NAICS 517911 Telecommunications Resellers. NAICS 517919 All Other Telecommunications. NAICS 519130 Internet Publishing and Broadcasting and Web Search Portals. NAICS 541711 Research and Development in Biotechnology. NAICS 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology). NAICS 561311 Employment Placement Agencies. NAICS 561312 Executive Search Services. Changes in Size Standards Resulting From SBA's Adoption of NAICS 2007 Most of the industries in NAICS 2002 remain unchanged under NAICS 2007. This direct final rule adopting NAICS 2007 will change size standards for only three industries and four activities from parts of industries. Other changes in NAICS 2007 consist of revised industry descriptions or the reclassification of industry activities in other industries having the same size standard. Table 4 lists all of OMB's modifications to the NAICS 2002 industries. The first three columns show the modified NAICS 2002 industry's six-digit code, its current size standard, and its industry description. The last three columns show the NAICS 2007 industry (new, existing and revised) that incorporates the modified NAICS 2002 industry, its industry description, and new size standard. By comparing the modified NAICS 2002 industry and size standard with the related NAICS 2007 industry and size standard, a user can identify the size standard SBA is adopting for the applicable NAICS 2007 industries. Following Table 4, SBA explains the basis for the limited number of cases that do result in a change to the size standard. Table 4 [This Table Includes Only Those NAICS Codes Where Size Standards are Affected. They Are Arranged According to the Order of Their NAICS 2007 Industry Codes] 2002 NAICS code Current size standards 2002 NAICS U.S. description 2007 NAICS code 2007 NAICS U.S. description New size standards 111211 $0.75 million Potato Farming 111211 Potato Farming $0.75 million. 111219* $0.75 million Other Vegetable (except Potato) and Melon Farming— *sweet potato and yam farming* 111219* $0.75 million Other Vegetable (except Potato) and Melon Farming— *except sweet potato and yam farming* 111219 Other Vegetable (except Potato) and Melon Farming $0.75 million. 111998* $0.75 million All Other Miscellaneous Crop Farming— *except algae, seaweed, and other plant aquaculture* 111998 All Other Miscellaneous Crop Farming $0.75 million. 112519 $0.75 million Other Animal Aquaculture 112519 Other Aquaculture $0.75 million. 111998* $0.75 million All Other Miscellaneous Crop Farming— *algae, seaweed, and other plant aquaculture* 314999 500 employees All Other Miscellaneous Textile Product Mills 314999 All Other Miscellaneous Textile Product Mills 500 employees. 315211* 500 employees Men's and Boys' Cut and Sew Apparel Contractors— *embroidery contractors* 315212* 500 employees Women's, Girls' and Infants' Cut and Sew Apparel Contractors— *embroidery contractors* 315211* 500 employees Men's and Boys' Cut and Sew Apparel Contractors— *except embroidery contractors* 315211 Men's and Boys' Cut and Sew Apparel Contractors 500 employees. 315212* 500 employees Women's, Girls' and Infants' Cut and Sew Apparel Contractors— *except embroidery contractors* 315212 Women's, Girls' and Infants' Cut and Sew Apparel Contractors 500 employees. 326199* 500 employees All Other Plastics Product Manufacturing— *except inflatable plastics boats* 326199 All Other Plastics Product Manufacturing 500 employees. 326291* 500 employees Rubber Product Manufacturing for Mechanical Use— *except rubber tubing for mechanical use* 326291 Rubber Product Manufacturing for Mechanical Use 500 employees. 326299* 500 employees All Other Rubber Product Manufacturing— *except inflatable rubber boats* 326299 All Other Rubber Product Manufacturing 500 employees. 326291* 500 employees Rubber Product Manufacturing for Mechanical Use— *rubber tubing for mechanical use* 333298 500 employees All Other Industrial Machinery Manufacturing 333298 All Other Industrial Machinery Manufacturing 500 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory distilling equipment* 333415 750 employees Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing 333415 Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing 750 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory freezers* 333994 500 employees Industrial Process Furnace and Oven Manufacturing 333994 Industrial Process Furnace and Oven Manufacturing 500 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory furnaces and ovens* 333997 500 employees Scale and Balance (except Laboratory) Manufacturing 333997 Scale and Balance Manufacturing 500 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory scales and balances* 333999 500 employees All Other Miscellaneous General Purpose Machinery Manufacturing 333999 All Other Miscellaneous General Purpose Machinery Manufacturing 500 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory centrifuges* 334220* 750 employees Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing— *except communications signal testing and evaluation equipment* 334220 Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing 750 employees. 334515 500 employees Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals 334515 Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals 500 employees. 334220* 750 employees Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing— *communications signal testing and evaluation equipment* 336612 500 employees Boat Building 336612 Boat Building 500 employees. 326199* 500 employees All Other Plastics Product Manufacturing— *inflatable plastics boats* 326299* 500 employees All Other Rubber Product Manufacturing— *inflatable rubber boats* 337127 500 employees Institutional Furniture Manufacturing 337127 Institutional Furniture Manufacturing 500 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory furniture (e.g., stools, tables, benches)* 339113 500 employees Surgical Appliance and Supplies Manufacturing 339113 Surgical Appliance and Supplies Manufacturing 500 employees. 339111* 500 employees Laboratory Apparatus and Furniture Manufacturing— *except laboratory furniture, scales, balances, furnaces, ovens, centrifuges, distilling equipment, and freezers* 517110 1500 employees Wired Telecommunications Carriers 517110 Wired Telecommunications Carriers 1,500 employees. 517510 $13.5 million Cable and Other Program Distribution. 518111* $23.0 million Internet Service Providers— *broadband Internet service providers (e.g., cable, DSL)* 517211 1500 employees Paging 517210 Wireless Telecommunications Carriers (except Satellite) 1,500 employees. 517212 1500 employees Cellular and Other Wireless Telecommunications. 517310 1500 employees Telecommunications Resellers 517911 Telecommunications Resellers 1,500 employees. 517910 $13.5 million Other Telecommunications 517919 All Other Telecommunications $23.0 million. 518111* $23.0 million Internet Service Providers— *ISPs providing services via client-supplied telecommunications connections* . 516110 500 employees Internet Publishing and Broadcasting 519130 Internet Publishing and Broadcasting and Web Search Portals 500 employees. 518112 $6.5 million Web Search Portals 519190 $6.5 million All Other Information Services 519190 All Other Information Services $6.5 million. 525990 $6.5 million Other Financial Vehicles 525990 Other Financial Vehicles $6.5 million. 525930* $6.5 million Real Estate Investment Trusts— *hybrid or mortgage REITs primarily in underwriting or investing in mortgages* . 531110 $6.5 million Lessors of Residential Buildings and Dwellings 531110 Lessors of Residential Buildings and Dwellings $6.5 million. 525930* $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing residential Buildings and Dwellings* 531120 $6.5 million Lessors of Nonresidential Buildings (except Miniwarehouses) 531120 Lessors of Nonresidential Buildings (except Miniwarehouses) $6.5 million. 525930* $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing nonresidential buildings* 531130 $23.5 million Lessors of Miniwarehouses and Self-Storage Units 531130 Lessors of Miniwarehouses and Self-Storage Units $23.5 million. 525930* $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing miniwarehouses and self-storage units* 531190 $6.5 million Lessors of Other Real Estate Property 531190 Lessors of Other Real Estate Property $6.5 million. 525930* $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing other real estate property* 541612* $6.5 million Human Resources and Executive Search Consulting Services— *except executive search consulting services* 541612 Human Resources Consulting Services $6.5 million. 541710* 500 employees Research and Development in the Physical, Engineering, and Life Sciences— *biotechnology research and development* 541711 Research and Development in Biotechnology 500 employees. 541710* 500 employees Research and Development in the Physical, Engineering, and Life Sciences— *except biotechnology research and development* 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) 500 employees. 561310 $6.5 million Employment Placement Agencies 561311 Employment Placement Agencies $6.5 million. 541612* $6.5 million Human Resources and Executive Search Consulting Services— *executive search consulting services* 561312 Executive Search Services $6.5 million. * Indicates that this activity within the identified NAICS 2002 code is now an activity within the related NAICS 2007 industry. As shown in Table 4, the NAICS 2007 modifications lead to a revision in the current size standard for a limited number of industries or activities. The basis for the revisions to seven size standards are discussed below: 1. NAICS 339111, “Laboratory Apparatus and Furniture Manufacturing,”
(part)*laboratory freezers.* NAICS 2007 eliminated NAICS 339111. The various activities of NAICS 339111 are reclassified in other NAICS 2007 codes having the same 500 employee size standard, except for laboratory freezer manufacturing. Laboratory freezer manufacturing is reclassified in NAICS 333415, “Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing,” having a size standard of 750 employees. SBA is adopting the 750 employee size standard for NAICS 333415 because laboratory freezer manufacturing represents a small part of that industry (Rule #3). 2. NAICS 334220, “Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing,”
(part)*communications signal testing and evaluation equipment.* The current size standard for NAICS 334220 is 750 employees. The activity of “communications signal testing and evaluation equipment manufacturing” in NAICS 2007 is reclassified in NAICS 334515, “Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals,” having a size standard of 500 employees. SBA is adopting the 500 employee size standard for NAICS 334515 because “communications signal testing and evaluation equipment manufacturing” represents a small part of that industry (Rule #3). 3. NAICS 518111, “Internet Service Providers,”
(part)*broadband Internet service providers (e.g., cable, DSL).* The current size standard for NAICS 518111 is $23.0 million in average annual receipts. The activity, “broadband Internet services providers ( *e.g.,* cable, DSL),” in NAICS 2007 is reclassified in NAICS 517110, “Wired Telecommunications Carriers,” having a 1,500 employee size standard. SBA is adopting the 1,500 employee size standard for NAICS 517110 because broadband Internet services providers represent a small part of that industry (Rule #3). 4. NAICS 517510, “Cable and Other Program Distribution.” NAICS 2007 eliminated NAICS 517510. The current size standard for NAICS 517510 is $13.5 million in average annual receipts. In NAICS 2007, all activities of NAICS 517510 are reclassified in 517110, “Wired Telecommunications Carriers,” having a 1,500 employee size standard. SBA is adopting the 1,500 employee size standard for NAICS 517110 because the Cable and Other Program Distribution industry is much smaller than the Wired Telecommunications Carriers industry (Rule #3). 5. NAICS 517910, “Other Telecommunications.” NAICS 2007 eliminated NAICS 517910. NAICS 2007 establishes a new industry titled “All Other Telecommunications,” NAICS 517919, comprising all activities of NAICS 517910 having a size standard of $13.5 million and most activities from NAICS 518111, “Internet Service Providers (ISP),” having a size standard of $23 million. As discussed in # 3 above, the activity of “broadband Internet services providers” in NAICS 518111 is reclassified in NAICS 517110. SBA is adopting the $23 million size standard for that industry because ISP establishments providing services via client-supplied telecommunications connections represent the larger component of the new NAICS 517919 (Rule #3). 6. NAICS 518112, “Web Search Portals.” NAICS 2007 eliminated NAICS 518112 and NAICS 516110, “Internet Publishing and Broadcasting,” having size standards of $6.5 million and 500 employees, respectively. NAICS 2007 combines these two industries to form a new six-digit industry—NAICS 519130, “Internet Publishing and Broadcasting and Web Search Portals.” SBA is adopting the 500 employee size standard for NAICS 519130 because the Internet Publishing and Broadcasting industry is much larger than the Web Search Portals industry (Rule #3). 7. NAICS 525930, “Real Estate Investment Trusts,”
(part)*hybrid or equity REITs primarily leasing miniwarehouses and self-storage units.* NAICS 2007 eliminated NAICS 525930. The various activities of NAICS 525930 are reclassified in NAICS 2007 codes having the same $6.5 million size standard, except for the activity of hybrid or equity REITs primarily leasing miniwarehouses and self-storage units. That activity is reclassified in NAICS 531130, “Lessors of Miniwarehouses and Self-Storage Units,” having a $23.5 million size standard. SBA is adopting the $23.5 million size standard for NAICS 531130 because hybrid or equity REITs primarily leasing miniwarehouses and self-storage units represent a small part of that industry (Rule #3). Justification for October 1, 2007 Effective Date If adopted in final form, SBA's table of small business size standards matched to NAICS 2007 will be effective on and will apply to all solicitations issued on or after October 1, 2007, because: 1. Federal Government recordkeeping and statistics would be more consistent and more comparable with other data for analyzing small business activity. October 1, 2007 is the start of the first Federal Government fiscal year after the NAICS 2007 January 1, 2007 effective date. 2. SBA and other users of size standards could collect data on their small business programs using the more recent NAICS format and can compare those data with future Federal statistics that will be based on NAICS 2007 industry classifications. The availability of such comparable data would ensure the credibility of analyses comparing program and industry data. 3. Federal agencies that use NAICS and SBA's small business size standards for their programs, as most of them do, will need time to implement the new size standards and to develop training tools necessary to do so. SBA believes that publishing this direct final rule now provides sufficient time for agencies to determine its impact on their programs and to convert and update their databases and tracking systems for implementation by the beginning of FY 2008. 4. To evaluate and establish small business size standards, SBA uses data that the U.S. Bureau of the Census (Census Bureau) compiles for the Agency from its quinquennial Economic Census of U. S. industry and businesses. SBA acquires this special compilation from the Census Bureau every five years, after each Economic Census. To evaluate and establish meaningful small business size standards, SBA requires the same data and on the same basis as the Census Bureau collects them. Because the next compilation that SBA will obtain from the Census Bureau will be based on NAICS 2007, SBA needs to use NAICS 2007 as the basis for its table of small business size standards. Alternatives To Adopting NAICS 2007 That SBA Considered SBA considered retaining the NAICS 2002 codes as the basis for small business size standards. However, SBA believes that doing so will lead to inconsistency among Federal agencies that adopt NAICS 2007 for their programs. More importantly, if SBA does not adopt NAICS 2007 it will not be able to analyze and evaluate small business size standards adequately because available Census Bureau data based on NAICS 2007 industries will not be comparable with NAICS 2002 industry data. Without useful data, SBA cannot properly analyze size standards and their effects on businesses. SBA considered segmenting the modified NAICS 2002 size standard for cases where the size standard changes instead of applying the guidelines used in previous NAICS revisions. SBA believes this alternative is impractical because it would complicate size standards for minor reasons. Furthermore, the application of the guidelines for NAICS 2007 results in the loss of eligibility for currently-defined small businesses in only one minor industry activity. That occurs for “communications signal testing and evaluation equipment manufacturing,” a part of NAICS 334220, “Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing.” The size standard for that activity decreases from 750 employees to 500 employees. A search of the Dynamic Small Business Search
(DSBS)reveals that there are 38 small businesses out of 2,200 small businesses registered in NAICS 334220 having more than 500 employees. However, it is unlikely that many of these businesses, if any, will be affected given the limited activity of “communications signal testing and evaluation equipment manufacturing.” All other activities in NAICS 334220 will continue to have a size standard of 750 employees. Consideration of Comments This is a direct final rule, but SBA will consider comments. SBA believes that this rule is routine and non-controversial, and SBA anticipates no significant adverse comments to this action. If SBA receives significant any adverse comments, it will withdraw this direct final rule. SBA is publishing concurrently in this issue of the **Federal Register** a proposed rule to modify its Small Business Size Regulations as contemplated in this direct final rule. If SBA does receive significant adverse comments, it will consider the comment(s) before making a final decision. If SBA decides to adopt NAICS 2007 as proposed, or with limited modifications, it will publish a final rule that addresses the comments and explains the basis for its final decision. Compliance With Executive Orders 12866, 12988, and 13132, the Paperwork Reduction Act (44 U.S.C. Ch. 35.) and the Regulatory Flexibility Act (5 U.S.C. 601-612) OMB has determined that this direct final rule is not a “significant” regulatory action for purposes of Executive Order (E.O.) 12866. This direct final rule incorporates the latest revisions of the NAICS, which SBA uses to identify industries in the United States economy for purposes of establishing small business size standards. As discussed in the preamble, the size standard of a limited number of activities would change because of the NAICS revisions. Almost all businesses currently defined as small under the NAICS 2002 industries would continue to be small under the NAICS 2007 industries, if adopted for size standards. The rule also affects Federal Government programs that provide a benefit for small businesses. SBA welcomes comments describing the impact on small businesses of the size standard changes resulting from this rule. For purposes of E.O. 12988, SBA has determined that this rule is drafted, to the extent practicable, in accordance with the standards set forth in that order. For purposes of E.O. 13132, SBA has determined that this rule does not have any federalism implications warranting the preparation of a Federalism Assessment. For purposes of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this rule does not impose any new reporting or recordkeeping requirements. When an agency promulgates a rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) requires the agency to prepare an initial regulatory flexibility analysis
(IRFA)describing the potential economic impact of the rule on small entities and alternatives that may minimize that impact. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an IRFA, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. SBA has determined that this direct final rule as drafted, including the alternatives discussed in the supplementary information above, would not have a significant impact on a substantial number of small entities. OMB's NAICS 2007 modifications will result in size standards changes to a minimal number of activities within certain NAICS industries detailed above in the supplementary information, with little, if any, affect on small businesses. Those activities are now part of other, more appropriate or new NAICS codes and their industry descriptions. There will be no changes to the size standards for most NAICS industries and their economic activities. For those that would change, they would create a larger number of enterprises that can qualify for Federal government programs reserved for small businesses. As stated above, a search of the Dynamic Small Business Search
(DSBS)reveals that there are 38 small businesses out of 2,200 small businesses registered in NAICS 334220 having more than 500 employees. However, it is unlikely that many of these businesses, if any, will be affected given the limited activity of “communications signal testing and evaluation equipment manufacturing.” All other activities in NAICS 334220 will continue to have a size standard of 750 employees. Therefore, SBA believes that the impact on small businesses will be minimal because these activities represent relatively minor components of the NAICS 2002 industries. When SBA published a direct final rule to replace the table of small business size standards based on NAICS 1997 with a new one based on NAICS 2002, it certified that for purposes of the Regulatory Flexibility Act, the rule would affect a significant number of small businesses, but that the impact on each business would not be substantial. (67 FR 52597 to 52606, 62292, 67253 and 67102) SBA received no comments to the contrary. No changes have occurred since then. Adopting NAICS 2007 to replace NAICS 2002 as the basis for its table of size standards would have, SBA believes, an even smaller impact. List of Subjects in 13 CFR Part 121 Administrative practice and procedure, Government procurement, Government property, Grant programs—business, Individuals with disabilities, Loan programs—business, Reporting and recordkeeping requirements, Small businesses. For the reasons set forth in the preamble, SBA amends 13 CFR part 121 as follows: PART 121—SMALL BUSINESS SIZE REGULATIONS 1. The authority citation for part 121 continues to read as follows: Authority: 15 U.S.C. 632, 634(b)(6), 636(b), 637(a), 644, and 662(5); and Pub. L. 105-135, Sec. 401, *et seq.,* 111 Stat, 2592. § 121.201 [Amended] 2. Amend § 121.201, in the table “Small Business Size Standards by NAICS Industry,” as follows: a. Revise the industry description of NAICS code 112519 “Other Animal Aquaculture” to read “Other Aquaculture.” b. Revise the heading “Sector 21—Mining” to read “Sector 21—Mining, Quarrying, and Oil and Gas Extraction.” c. Revise the industry description of NAICS code 238210, “Electrical Contractors,” to read “Electrical Contractors and other Wiring Installation Contractors.” d. Revise the industry description of NAICS code 316999, “All Other Leather Good Manufacturing,” to read “All Other Leather Good and Allied Product Manufacturing.” e. Revise the industry description of NAICS code 322221, “Coated and Laminated Packaging Paper and Plastics Film Manufacturing,” to read “Coated and Laminated Packaging Paper Manufacturing.” f. Revise the industry description of NAICS code 326111, “Unsupported Plastics Bag Manufacturing,” to read “Plastics Bag and Pouch Manufacturing.” g. Revise the industry description of NAICS code 333997, “Scale and Balance (except Laboratory) Manufacturing,” to read “Scale and Balance Manufacturing.” h. Remove the entry NAICS code 339111, “Laboratory Apparatus and Furniture Manufacturing.” i. Revise the industry description of NAICS code 441221, “Motorcycle Dealers,” to read “Motorcycle, ATV, and Personal Watercraft Dealers.” j. Revise the heading “Sectors 48-49—Transportation” to read “Sectors 48-49—Transportation and Warehousing.” k. Revise the industry description of NAICS code 492110, “Couriers,” to read “Couriers and Express Delivery Services.” l. Remove the heading “Subsector 516—Internet Publishing and Broadcasting” and the entry for NAICS code 516110, “Internet Publishing and Broadcasting.” m. Remove the entries for NAICS codes 517211, “Paging;” 517212, “Cellular and Wireless Telecommunications;” and 517310, “Telecommunications Resellers” and add in their place the following: 517210 Wireless Telecommunications Carriers (except Satellite) 1,500 n. Remove the entries for NAICS codes 517510, “Cable and Other Program Distribution,” and 517910, “Other Telecommunications,” and add in their place the following: 517911 Telecommunications Resellers 1,500 517919 All Other Telecommunications $23.5 o. Revise the heading “Subsector 518—Internet Service Providers, Web Search Portals, and Data Processing Services” to read “Subsector 518—Data Processing, Hosting, and Related Services.” p. Remove the entries for NAICS codes 518111, “Internet Service Providers,” and 518112, “Web Search Portals.” q. Add immediately after entry for NAICS code 519120, “ Libraries and Archives” the following: 519130 Internet Publishing and Broadcasting and Web Search Portals 500 r. Revise the heading “Subsector 523—Financial Investments and Related Activities” to read “Subsector 523—Securities, Commodity Contracts, and Other Financial Investments and Related Activities.” s. Revise the industry description of NAICS code 541612, “Human Resources and Executive Search Consulting Services,” to read “Human Resources Consulting Services.” t. Remove the entry NAICS code 541710, “Research and Development in the Physical, Engineering, and Life Sciences,” and add in its place the following: 541711 Research and Development in Biotechnology. 11 11 500 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology). 11 11 500 *Except,* Aircraft 1,500 *Except,* Aircraft Parts, and Auxiliary Equipment, and Aircraft Engine Parts 1,000 *Except,* Space Vehicles and Guided Missiles, their Propulsion Units, their Propulsion Units Parts, and their Auxiliary Equipment and Parts 1,000 u. Remove the entry for NAICS code 561310, “Employment Placement Agencies,” and add in its place the following: 561311 Employment Placement Agencies $6.5 561312 Executive Search Services $6.5 v. Revise the industry description of NAICS code 561422, “Telemarketing Bureaus,” to read “Telemarketing Bureaus and Other Contact Centers.” w. Revise the industry description of NAICS code 722212, “Cafeterias,” to read “Cafeterias, Grill Buffets, and Buffets.” x. Revise the heading “Sector 81—Other Services” to read “Sector 81—Other Services (except Public Administration).” y. Amend footnote 11 by removing *“NAICS code 541710”* and adding in its place *“NAICS codes 541711 and 541712.”* Dated: August 23, 2007. Steven C. Preston, Administrator. [FR Doc. E7-17151 Filed 8-28-07; 8:45 am] BILLING CODE 8025-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0157; FRL-8143-9] Propylene Oxide; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of propylene oxide and for the reaction product, propylene chlorohydrin, in or on fig; grape, raisin; and plum, prune, dried, when used as a post-harvest fumigant. This rule additionally removes all directions for use currently listed in 40 CFR 180.491. Aberco, Incorporated requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 29, 2007. Objections and requests for hearings must be received on or before October 29, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2005-0157. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-9443; e-mail address: *kish.tony@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0157 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before October 29, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2005-0157, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of June 27, 2007 (72 FR 35242) (FRL-8133-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F6904) by Aberco, Incorporated, 9430 Lanham-Severn Road, Seabrook, MD 20706. The petition requested that 40 CFR 180.491 be amended by establishing a tolerance for residues of the post-harvest fumigant propylene oxide, in or on fig; grape, raisin; and plum, prune, dried at 3.0; 1.0; and 2.0; respectively parts per million (ppm); and that the directions for use currently listed in 40 CFR 180.491 under paragraphs (a)(2) and (a)(4) be deleted. The petition also identified propylene chlorohydrin as a metabolite and included an enforcement method for determination of residues of propylene oxide, propylene chlorohydrin, and propylene bromohydrin in nutmeats, cocoa, and dried spices. That notice referenced a summary of the petition prepared by Aberco, Incorporated, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. The current propylene oxide tolerances include some specific directions for use regarding fumigation frequency, duration and temperature. These directions are currently on affected labels. Because these directions are already on the label, they do not need to be duplicated as part of the tolerance. Furthermore, the propylene oxide Reregistration Eligibility Document
(RED)of August 2006 found that these directions should be modified on the label to exactly match the conditions under which residue trials were conducted. Therefore, all directions in 40 CFR 180.491, paragraphs (a)(2) and (a)(4) are no longer needed and can be removed. Similarly, the use directions and other information in paragraphs (a)(1), and (a)(5) can also be removed. As noted in the petition and the RED, use of propylene oxide can result in residues of propylene oxide as well as the reaction product propylene chlorohydrin. Commodities that contain salts that are treated with propylene oxide can react with chloride ion to form the propylene chlorohydrin. Propylene oxide and propylene chlorohydrin are considered separately as residues of concern for risk assessment and tolerance assessment. Based on the differences in physical-chemical properties and toxicological effects, propylene oxide and propylene chlorohydrin were assessed separately, and, EPA is establishing separate tolerances for these chemicals within different paragraphs of tolerance regulation for propylene oxide. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to the FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of propylene oxide in or on fig; grape, raisin; and plum, prune, dried at 3.0; 1.0; and 2.0 ppm, respectively; and in addition, for residues of the reaction product propylene chlorohydrin at 3.0; 4.0; and 2.0, ppm, respectively. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by propylene oxide and propylene chlorohydrin, as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov under the docket number for this rule* . B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment. Uncertainty/safety factors
(UF)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. Short-, intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see: *http://www.epa.gov/oppfead1/trac/science.* *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . *http://www.epa.gov/pesticides/trac/science/aggregate.pdf* . A summary of the toxicological endpoints for propylene oxide and propylene chlorohydrin used for human risk assessment can be found at www.regulations.gov in the risk assessment document “Propylene Oxide-Revised HED Risk Assessment for Reregistration Eligibility Decision Document, July 31, 2006” at Table 4.4.10 on page 49/95 in Docket ID EPA-HQ-OPP-2005-0157. This identical table can also be found in the Propylene oxide RED document at the following website address: *http://www.epa.gov/oppsrrd1/REDs/propylene_oxide_red.pdf.* C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to propylene oxide and propylene chlorohydrin, EPA considered exposure under the petitioned-for tolerances as well as all existing propylene oxide tolerances in (40 CFR 180.491). EPA assessed dietary exposures from propylene oxide and propylene chlorohydrin in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure for propylene oxide and propylene chlorohydrin, EPA used food consumption information from the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA relied upon average field trial residue data and percent crop treated information for all commodities covered by existing tolerances. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide (CSFII). As to residue levels in food, EPA relied upon average field trial residue data for propylene oxide, tolerance level residues for propylene chlorohydrin, and percent crop treated information for all commodities covered by existing propylene oxide tolerances. iii. *Cancer* . The cancer assessment for propylene oxide incorporated new residue and percent crop treated data for nutmeats and omitted guar (edible gums) as a fumigated commodity. No cancer exposure assessment is needed for propylene chlorohydrin because the cancer data which were negative for both rats and mice, showed no cancer risk to humans. iv. *Anticipated residue and percent crop treated
(PCT)information* . Section 408(b)(2)(E) of the 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 residues that have been measured in food. If EPA relies on such information, EPA must pursuant to 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. For the present action, EPA will issue such data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under section 408(f)(1) of FFDCA. Data 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: a. The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; b. The exposure estimate does not underestimate exposure for any significant subpopulation group; and c. Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: The percent crop treated values used were as follows: Herbs, spices, and bulb vegetables at 1%; tree nuts at 2%; cocoa bean at 1.3%; and 100% for the new proposed uses — fig grape; raisin; and plum, prune, dried. The Agency believes that the three conditions listed above 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 propylene oxide may be applied in a particular area. 2. *Dietary exposure from drinking water* . For propylene oxide fumigations, residues of propylene oxide and propylene chlorohydrin from drinking water are expected to be negligible because i. Fumigations are either in closed chambers with emission reduction technology, or in temporary/intermittent outdoor field locations (tents, tarps, rail cars, etc.) at a use rate 53 times lower than that used in closed chambers, both of which result in minimal emissions, and ii. Due to atmospheric dilution and the physical-chemical characteristics of propylene oxide, negligible residues are expected to be able to enter soil and any nearby water. Therefore, water exposures were not included in the risk assessment. 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). Propylene oxide and propylene chlorohydrin are not registered for use on any residential sites. However, exposure could occur to people residing near fumigation facilities. Propylene oxide and propylene chlorohydrin emissions monitoring data necessary to quantitatively estimate exposures and risks from sterilization/fumigation facilities are unavailable. Therefore, a qualitative assessment was conducted comparing the risks associated with fugitive emissions from the use of a similar chemical, ethylene oxide, in similar commercial fumigation scenarios. With the use of required buffer zones at designated distances to be added to labels, the assessment found that propylene oxide and propylene chlorohydrin residential exposure risks are not expected to be of concern. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to propylene oxide or propylene chlorohydrin and any other substances and propylene oxide or propylene chlorohydrin do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that propylene oxide or propylene chlorohydrin have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . For propylene oxide, there is no quantitative susceptibility between the rat fetuses and the dams from the rat developmental study. The study indicated a possible qualitative susceptibility since the skeletal variations (increased litter incidence for the accessory 7th cervical rib) were observed at the same dose which produced maternal toxic effects (ie. decreased body weight gain, food consumption and food efficiency). The effects in the rat fetuses are being treated as only possible evidence of qualitative sensitivity because it is questionable as to whether an accessory 7th cervical rib, which is a developmental variation, is properly characterized as a more severe effect than decreased body weight gain. Although further analysis, including consideration of historical control information on this effect, might resolve this question, in the absence of this analysis, EPA is taking the conservative position that this particular skeletal variation is possible evidence of qualitative sensitivity. Susceptibility in rabbits could not be adequately ascertained due to the absence of an acceptable rabbit developmental study. In the 2-generation reproduction study, there is no evidence for quantitative or qualitative susceptibility in pups exposed to propylene oxide since no offspring effects were seen at doses which produced significant systemic toxicity in parents. The degree of concern for the possible qualitative susceptibility effects seen after *in utero* exposures in rats was low because the effects (ie. increased incidence of the 7th cervical rib) are: i. Skeletal variations and not malformations, ii. Were seen in the presence of maternal toxicity, iii. A clear NOAEL was identified, and iv. This endpoint is used for assessing potential acute dietary risk to the population of concern (Females 13-49). For propylene chlorohydrin, in the reproduction study, quantitative susceptibility effects were evident because decreased pup weights were observed at a dose which had no systemic toxicity in the dams. However, the degree of concern is low for the quantitative susceptibility seen in the reproduction study because a clear NOAEL was identified, and that dose and the endpoint of this study is used for assessing chronic dietary risk in conjunction with the retaining of a 10X database uncertainty factor. 3. *Conclusion* . For both propylene oxide and propylene chlorohydrin, EPA has determined it is necessary to retain the additional 10X safety factor for the protection of infants and children due to the absence of a propylene oxide developmental toxicity study in rabbits, and a chronic study in non-rodents by the oral route; and for propylene chlorohydrin, due to the absence of a developmental toxicity study in rats and rabbits, a chronic toxicity study in nonrodents, and a chronic carcinogenicity study in rats and mice (because the doses used in the existing studies found in the literature are inadequate). Because no acute endpoint has been identified for propylene chlorohydrin, EPA has applied the additional 10X safety factor to the chronic endpoint in assessing acute risk for propylene chlorohydrin. This is a very conservative approach to assessing acute risk because repeated exposure to a pesticide would typically result in lower NOAELs than an acute exposure. For propylene oxide, there is no evidence for quantitative or qualitative susceptibility in pups exposed to the chemical. For propylene chlorohydrin, the degree of concern is also low for the quantitative susceptibility seen in the reproduction study since the dose and the endpoint of this study is used for assessing chronic dietary risk in conjunction with the retaining of the 10X database uncertainty factor. No additional FQPA factor above 10X is required for either propylene oxide or propylene chlorohydrin. Propylene oxide is missing an adequate rabbit developmental study and a chronic study in a non-rodent species, but an existing developmental study in rabbits indicates effects occur at high doses and a chronic study in rodents is available, therefore a factor of 10X is sufficient. For propylene chlorohydrin, although there are data gaps, there are acceptable longer term studies including chronic studies in rats and mice and a reproduction study in rats. Given these chronic data, an additional safety factor of 10X should be sufficient for the protection of infants and children, as well as the general population and other major identifiable subgroups, from chronic exposure to propylene chlorohydrin. Further, use of the chronic endpoint and the additional 10X safety factor to assess acute risk is such a conservative approach to assessing acute risk that no further safety factor for this risk assessment. Other relevant factors here are that: i. There is no indication that propylene oxide or propylene chlorohydrin are neurotoxic chemicals and there is no need for developmental neurotoxicity studies or additional uncertainty factors to account for neurotoxicity; and ii. The exposure databases is unlikely to underestimate exposure because it is based on reliable data on anticipated residues and percent crop treated information. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-, 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. As discussed prior, because propylene oxide and propylene chlorohydrin residues which could enter water are expected to be negligible, water exposures were not included in the aggregate risk assessments. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from only food to propylene oxide will occupy 7% of the aPAD for the population group (females 13-49 years old) receiving the greatest exposure. Because no acute endpoint has been identified for propylene chlorohydrin, EPA has assessed acute risk for propylene chlorohydrin using the cPAD for propylene chlorohydrin. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from only food to propylene chlorohydrin will occupy 90% of the cPAD for the population group receiving the greatest exposure (infants less than one year old). 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propylene oxide from only food will utilize 14% of the cPAD for the population group (children 3-5 years). Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propylene chlorohydrin from only food will utilize 29% of the cPAD for the population group (children 1-2 years). There are no residential uses for propylene oxide or propylene chlorohydrin, but residential bystanders may be exposed to air emissions from fumigation facilities or structures. However, dietary and bystander exposure for either propylene oxide or propylene chlorohydrin cannot be combined for this assessment because the endpoints selected for these exposures are not based on a common effect. Therefore, risk from dietary and inhalation routes were not aggregated. 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). Though residential exposure could occur with the use of propylene oxide, the potential short-term exposures to propylene oxide and propylene chlorohydrin were not aggregated with chronic dietary food and water exposures for the same because the toxic effects are different. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Though residential exposure could occur with the use of propylene oxide, the potential intermediate-term exposures propylene oxide and propylene chlorohydrin were not aggregated with chronic dietary food and water exposures for the same because the toxic effects are different. 5. *Aggregate cancer risk for U.S. population* . The cancer dietary risk estimates for propylene oxide are below EPA's level of concern; the cancer dietary excess lifetime risk estimate for the U.S. general population is 4x10 -7 . EPA considers risks in the range of 1 x 10 -6 (such as the cancer risk for propylene oxide) to be negligible and thus pose a reasonable certainty of no harm. There is no cancer risk for propylene chlorohydrin as evidenced by the cancer data which were negative for both rats and mice. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to propylene oxide and propylene chlorohydrin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology is available to enforce the tolerance expression. An acceptable method was submitted (ABC.METHOD 46306-PPO/Hydrins Rev 1.0; MRID 45301902) which is able to quantify propylene oxide and propylene chlorohydrin residues in various commodities using headspace gas chromatography with flame ionization detection. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no Codex Maximum Residue Levels
(MRLs)for residues of propylene oxide and propylene chlorohydrin in any commodity. No Canadian or Mexican MRLs have been established. V. Conclusion Therefore, tolerances are established for residues of propylene oxide when used as a post harvest fumigant, in or on fig; grape, raisin; and plum, prune, dried, at 3.0; 1.0; and 2.0; respectively ppm, and separate tolerances are established for the reaction product, propylene chlorohydrin, in or on fig; grape, raisin; and plum, prune, dried, at 3.0, 4.0, and 2.0 ppm, respectively. The use directions currently listed in 40 CFR 180.491 paragraphs (a)(1), (a)(2), (a)(4) and (a)(5) are also being removed. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 17, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—AMENDED 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.491 is amended by revising paragraph
(a)to read as follows: § 180.491 Propylene oxide; tolerances for residues.
(a)*General* .
(1)Tolerances are established for residues of propylene oxide when used as a postharvest fumigant in or on the following food commodities: Commodity Parts per million Cocoa bean, bean 300 Fig 3.0 Grape, raisin 1.0 Gum, edible 300 Nutmeat, processed, except peanuts 300 Plum, prune, dried 2.0 Spices, processed 300
(2)Tolerances are established for the reaction product, propylene chlorohydrin, from use of propylene oxide as a postharverst fumigant, in or on the following food commodities: Commodity Parts per million Fig 3.0 Grape, raisin 4.0 Plum, prune, dried 2.0 [FR Doc. E7-17010 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0349; FRL-8142-1] Spinosad; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of spinosad in or on fish; fish-shellfish, mollusc; and fish-shellfish, crustacean. Dow AgroSciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 29, 2007. Objections and requests for hearings must be received on or before October 29, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0349. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-6463; e-mail address: *madden.barbara@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0349 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before October 29, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0349, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of May 9, 2007 (72 FR 26375) (FRL-8128-1), 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 petition (PP 7F7191) by Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268-1053. The petition requested that 40 CFR 180.495 be amended by establishing tolerances for residues of the insecticide spinosad in or on fish; fish-shellfish, molluscs and fish-shellfish crustaceans at 4.0 parts per million (ppm). Spinosad is a fermentation product of *Saccharopolyspora spinosa* , consisting of two related 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-2 *H* -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1 *H* -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-2 *H* -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1 *H* -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione. That notice referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to the FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of spinosad on fish; fish-shellfish, crustacean; and fish-shellfish, mollusc at 4.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. On March 21, 2007 the Agency published a final rule (72 FR 13168 FRL-8114-4) establishing tolerances for residues of spinosad 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 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. When the Agency conducted the risk assessments in support of this tolerance action it assumed that spinosad residues would be present on fish and shellfish (crustacean and mollusc) as well as on all foods covered by the proposed and established tolerances. Residues on fish and shellfish were included because there was a pending application under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 *et seq* ., to register spinosad for aquatic use as a mosquito larvacide, a use the Agency determined could result in residues in fish and shellfish. Therefore, establishing the fish and shellfish tolerances will not change the most recent estimated aggregate risks resulting from use of spinosad, as discussed in the **Federal Register** of March 21, 2007. Refer to the March 21, 2007 (72 FR 13168) **Federal Register** document, available at *http://www.regulations.gov* , for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the **Federal Register** document in support of this action. Based on the risk assessments discussed in the final rule published in the **Federal Register** of March 21, 2007 (72 FR 13168), 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 Adequate enforcement methodology (Liquid Chromatography/Mass Spectroscopy - Accelerated Climate Prediction Initiative) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no established or proposed CODEX Maximum Residue Limits
(MRLs)or Canadian or Mexican MRLs for residues of spinosad in or on fish or shellfish. V. Conclusion Therefore, tolerances are established for residues of spinosad, consisting of the related active ingredients Spinosyn A, 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-1 *H* -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D, 2-[(6-deoxy-2,3,4-tri- *O* -methyl-α- *L* -manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2 *H* -pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1 *H* -as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on fish; fish-shellfish, crustacean; and fish-shellfish, mollusc at 4.0 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the National government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 17, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.495 is amended by alphabetically adding the following commodities to the table in paragraph
(a)to read as follows: § 180.495 Spinosad; tolerances for residues.
(a)* * * Commodity Parts per million Expiration/Revocation Date * * * * * Fish 4.0 None Fish-shellfish, crustacean 4.0 None Fish-shellfish, mollusc 4.0 None * * * * * [FR Doc. E7-16897 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0428; FRL-8138-6] Flusilazole; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes time-limited tolerances for residues of flusilazole in or on soybean seed, soybean aspirated grain fractions, and soybean oil. This action is in response to EPA's granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on soybeans. This regulation establishes maximum permissible levels for residues of flusilazole in these food commodities. The tolerances expire and are revoked on December 31, 2010. DATES: This regulation is effective August 29, 2007. Objections and requests for hearings must be received on or before October 29, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0428. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the Office of Pesticide Programs
(OPP)Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-9356; e-mail address: *conrath.andrea@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-2007-0428 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 October 29, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0428, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for residues of the fungicide flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole), in or on soybean seed at 0.04 parts per million (ppm), soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10 ppm. These tolerances expire and are revoked on December 31, 2010. EPA will publish a document in the **Federal Register** to remove the revoked tolerances from the Code of Federal Regulations (CFR). Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Flusilazole on Soybeans and FFDCA Tolerances Australasian soybean rust
(SBR)is a plant disease caused by 2 fungal species, *Phakopsora pachyrhizi* and *P. meibomiae* , and is spread primarily by windborne spores that can be transported over long distances. SBR models suggest that most of the soybean acreage in the U.S. could be compromised by an SBR epidemic. In accordance with the 2002 Agricultural Bioterrorism Protection Act, SBR was identified by the United Stated Department of Agriculture
(USDA)as a select biological agent with the potential to pose a severe threat to the soybean industry and livestock production, in general. As such, USDA has invested in extensive readiness and outreach activities among soybean producers. EPA has authorized under FIFRA section 18 the use of flusilazole on soybeans for control of Australasian Soybean Rust in Minnesota and South Dakota. After having reviewed the states' submissions, EPA concurs that emergency conditions exist for these States. As part of its assessment of these emergency exemptions, EPA assessed the potential risks presented by residues of flusilazole in or on soybean seed, aspirated grain fractions, and oil. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances expire and are revoked on December 31, 2010, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on soybean seed, aspirated grain fractions, and oil after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed levels that were authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether flusilazole meets EPA's registration requirements for use on soybean or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as the basis for registration of flusilazole by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for use of this pesticide on this crop under section 18 of FIFRA by any State other than those following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for flusilazole, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of flusilazole and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for time-limited tolerances for residues of flusilazole in or on soybean seed at 0.04 ppm, soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows. A. Toxicological Endpoints The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological endpoint. However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is applied in order to protect infants and children, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non-dietary risk assessments (other than cancer) the UF is used to determine the level of concern (LOC). For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure
(MOE)= NOAEL/exposure) is calculated and compared to the LOC. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE <sup>cancer</sup> = point of departure/exposures) is calculated. A summary of the toxicological endpoints for flusilazole used for human risk assessment is discussed in Table 2.3 on page 15 of the human health risk assessment found at *http://www.regulations.gov* Docket No. EPA-HQ-OPP-2007-0428-0001. B. Exposure Assessment 1. *Dietary exposure from food and feed uses* . There are currently no tolerances established for this chemical, and it is not registered in the US. Risk assessments were conducted by EPA to assess dietary exposures from flusilazole in food as follows: i. *Acute exposure* . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. EPA used the Dietary Exposure Evaluation Model (DEEM TM ) and data on individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) to estimate exposure to the chemical for each commodity. This acute risk assessment used conservative and high end assumptions to estimate acute exposure and risk, as follows: It was assumed that flusilazole residues in soybean commodities would be at proposed tolerance levels or higher; default processing factors were applied to account for effects that may occur on flusilazole residues from processing into soybean oil; an additional factor was incorporated to account for potential residues of the metabolite of flusilazole, which may occur in soybean commodities; and it was assumed that 100% of the soybean crop grown in the US would be treated. No refinements such as incorporating anticipated residue values or percent of crop treated
(PCT)assumptions were used. A high-end estimate for contribution to dietary exposure from residues occurring in drinking water, was incorporated directly into the dietary assessment using the 30-year average annual concentration for surface water generated by the Agency's computer simulation, the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM-EXAMS). ii. *Chronic exposure* . In conducting this chronic dietary risk assessment EPA used the DEEM TM and data on individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII to estimate exposure to the chemical for each commodity. The chronic risk assessment also used the same conservative and high-end assumptions as described above in Unit IV.B.1.i., for calculation of the acute exposure estimates and risk. iii. *Cancer* . The cancer risk assessment incorporated the same dietary exposure estimates as used for the chronic assessment, and used conservative and high-end assumptions to calculate cancer risk estimates over a lifetime of exposure, as described above in Unit IV.B.1.i. 2. *Dietary exposure from drinking water* . Since this exemption is the only use of a new pesticide in the US, there are no residues in drinking water, and thus there are no monitoring exposure data to use for a comprehensive dietary exposure analysis and risk assessment for flusilazole in drinking water. Because of this, the Agency calculated drinking water concentration estimates which may occur from this use, by reliance on simulation or modeling taking into account data on the physical characteristics of flusilazole. None of the models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health LOC. Based on available data, and for this section 18 use only, the Agency determined that the residue of concern for drinking water is flusilazole *per se* . Some surface and ground water contamination may occur based on the proposed application rates and the environmental fate properties of flusilazole, although mobility in soil is expected to be low. Based on Tier II screening-level surface water modeling for drinking water, the Agency estimated concentrations in surface water to be used for acute, chronic non-cancer, and cancer exposure assessment. Tier II surface water concentrations for parent flusilazole were calculated using PRZM-EXAMS. PRZM/EXAMS incorporates an index reservoir environment and includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. EPA used the Screening Concentration Ground Water (SCI-GROW2) model to estimate ground water concentrations. These results for both surface and ground water are consistent with the fate and transport properties of flusilazole. Modeled estimates of drinking water concentrations were incorporated directly into the dietary assessments using the estimated drinking water concentrations
(EDWC)for surface water generated by the PRZM-EXAMS model. For the acute assessment, the peak concentration of 1.81 parts per billion
(ppb)was used to assess the contribution to surface drinking water; for the chronic assessment, the annual mean value of 0.92 ppb was used to assess the contribution to surface drinking water. The EDWC for groundwater was estimated by SCI-GROW2 at 0.05 ppb. Since the EDWC estimated by SCI-GROW2 for groundwater was lower, at 0.05 ppb, the higher, more conservative, surface water estimate of 1.81 ppb was used for assessing contribution to dietary exposures. 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). Flusilazole is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and“ other substances that have a common mechanism of toxicity.” Flusilazole is a member of the triazole-containing class of pesticides. Although triazole pesticides act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between this pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). In triazoles a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the triazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that triazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the triazole pesticides. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . Flusilazole is a triazole-derived pesticide. This class of compounds can form the common metabolites 1,2,4-triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derived pesticides, EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, on the assessment involving the 1,2,4-triazole metabolites, the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment may be found at *http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf* . In that risk assessment, EPA concluded that, based upon the available information and on conservative estimates of hazard and exposure, there are no human health risk issues associated with 1,2,4-triazole or its metabolites that would preclude re-registration of the triazole-derivative fungicides registered to date or conditional registrations of the triazole-derivative fungicides that have been proposed as of September 1, 2005, which included the use of flusilazole on soybean. C. Safety Factor for Infants and Children 1. *In general* . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. *Developmental and Reproductive toxicity studies* . There are several developmental and 2-generation reproduction studies in rats and rabbits that provide evidence of increased susceptibility to in utero and/or pre-, postnatal exposure to flusilazole. Developmental effects such as cleft palate, resorption and skeletal malformations were observed in rats. In rabbits, increased resorptions were observed. In both species, these effects occurred either in the absence of maternal toxicity and/or at a dose that caused only marginal maternal toxicity (decreased food consumption, body weight gain). In a multi-generation reproduction study in rats a decrease in pup viability at birth and decreased post-natal survival were observed either in the absence of maternal toxicity and/or at a dose that caused only marginal maternal toxicity. 3. *Prenatal and postnatal sensitivity* . The evidence of increased susceptibility observed in rats and rabbits is off-set because EPA has set the acute (0.02 milligrams/kilograms (mg/kg) and chronic (0.002 mg/kg) RfDs below the dose at which these developmental effects were observed, and these are therefore protective with respect to these effects. Although NOAELs were not identified in some developmental and 2-generation reproduction studies, there are well established NOAELs in most of the developmental and 2-generation reproduction studies, and the RfDs are below these NOAELs. Because EPA has set the RfDs well below the levels at which developmental effects are observed, the increased susceptibility seen in these studies does not warrant retaining the 10X FQPA safety factor (i.e., it is 1X). 4. *Conclusion* . For the purpose of this emergency quarantine exemption, EPA relied on studies reviewed by the European Union as well as some preliminary internal study reviews. Therefore, the stated toxicological endpoints are applicable for this emergency section 18 use only, since upon detailed review of the new and existing data, the final conclusions may change. EPA determined that, in terms of hazard, there are low concerns and no residual uncertainties with regard to pre-and/or post-natal toxicity. EPA determined that the FQPA 10X safety factor to protect infants and children should be removed (reduced to 1X) based on the following: i. The toxicity database for flusilazole is complete. ii.The dietary food exposure assessment utilizes proposed tolerance-level or higher residues and 100% CT information for all commodities. By using these screening-level assessments, acute and chronic exposures/risks will not be underestimated. iii.The dietary drinking water assessment (Tier 2 estimates) utilizes values generated by model and associated modeling parameters which are designed to provide conservative, health-protective, high-end estimates of water concentrations. iv.There are no residential uses of flusilazole. D. Aggregate Risks and Determination of Safety The Agency currently has two ways to estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses. First, a screening assessment can be used, in which the Agency calculates drinking water levels of comparison (DWLOCs), which are used as a point of comparison against estimated drinking water concentrations (EDWCs). The DWLOC values are not regulatory standards for drinking water, but are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. More information on the use of DWLOCs in dietary aggregate risk assessments can be found at *http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf* . More recently, the Agency has used another approach to estimate aggregate exposure through food, residential and drinking water pathways. In this approach, modeled surface water and ground water EDWCs are directly incorporated into the dietary exposure analysis, along with food. This approach provides a more realistic estimate of exposure because actual body weights and water exposures are then added to estimates and water consumption from the CSFII are used. The combined food and water exposures are then added to estimated exposure from residential sources to calculate aggregate risks. The resulting exposure and risk estimates are still considered to be high end, due to the assumptions used in developing drinking water modeling inputs. The risk assessment for flusilazole used in this tolerance document uses this approach of incorporating water exposure directly in to the dietary exposure analysis. There are no registered or proposed uses of flusilazole, which result in residential exposures, so the aggregate exposure assessment required by FFDCA section 408(b)(2)(D)(vi) consists solely of dietary (food + drinking water) exposures. Aggregate exposure risk assessments were conducted by incorporating the drinking water concentrations directly into the dietary exposure assessment for the acute and chronic aggregate exposures (food + drinking water). These aggregate exposures do not exceed the Agency's LOC since they were less than 100% of the acute and chronic population adjusted doses (PADs). 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and drinking water to flusilazole is estimated at 0.000326 mg/kg/day, and occupies 1.6% of the aPAD for females 13-49 years, the population subgroup of concern. There were no acute toxicity concerns for other population subgroups noted, based upon the available toxicology studies, and therefore, no acute toxicology endpoints assigned. Therefore, EPA does not expect aggregate dietary exposure for this population subgroup of concern to exceed the LOC of 100% of the aPAD. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flusilazole from food and water will utilize 8.1% of the cPAD for the U.S. population, 21% of the cPAD for All Infants <1 year old (the most highly exposed subpopulation), and 17% of the cPAD for Children 1-2 years old, and Children 3-5 years old (both subgroups). Flusilazole is unregistered, and therefore there are no residential uses or exposures. EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table of this unit: **Aggregate Risk Assessment for Chronic (Non-Cancer) Dietary (Food + Water) Exposure to Flusilazole** Population Subgroup Dietary exposure (mg/kg/day) % cPAD utilized General U.S. Population 0.000162 8.1 All Infants (< 1 year old) 0.000429 21 Children 1-2 years old 0.000334 17 Children 3-5 years old 0.000338 17 Children 6-12 years old 0.000243 12 Youth 13-19 years old 0.000161 8.0 Adults 20-49 years old 0.000143 6.7 Adults 50+ years old 0.000110 5.5 Females 13-49 years old 0.000128 6.4 3. *Short-term and intermediate risks* . Short-term and intermediate aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Flusilazole is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which were previously addressed. 4. *Aggregate cancer risk for U.S. population* . In its cancer analysis, EPA assumed 100% of the soybean crop in the US would be treated with flusilazole. EPA used the DEEM 7.81 default processing factors to estimate residues that might occur in processed commodities (i.e. soybean oil) and assumed that flusilazole residues in or on soybean commodities would be equal to the proposed tolerance levels. Drinking water was incorporated directly into the dietary assessment using the 30-year average annual concentration for surface water generated by the PRZM-EXAMS model as a high-end estimate. The resulting cancer risk estimate for the general U.S. population (4.5 x 10 - 7 ) was less than EPA's LOC (generally 1 x 10 - 6 ). 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 flusilazole residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodologies (gas chromatography/nitrogen-phosphorus detector; and gas chromatography/mass-selective detector) are available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs)for the residues of flusilazole on soybean commodities. Therefore, there are no international harmonization concerns at this time. VI. Conclusion Therefore, the tolerances are established for residues of flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole), in or on soybean seed at 0.04 parts per million (ppm), soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10 ppm. VII. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 22, 2007. Martha Monell, Acting Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.630 is added to read as follows: § 180.630 Flusilazole; tolerances for residues.
(a)*General* . [Reserved]
(b)*Section 18 emergency exemptions* . Time-limited tolerances are established for residues of the fungicide, flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole) in connection with use of the pesticide under Section 18 emergency exemptions granted by EPA. The tolerances expire and are revoked on the dates specified in the following table. Commodity Parts per million Expiration/revocation date Soybean, aspirated grain fractions 2.6 12/31/2010 Soybean, seed 0.04 12/31/2010 Soybean, oil 0.10 12/31/2010
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect or inadvertant residues* . [Reserved] [FR Doc. E7-17110 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0327; FRL-8135-6] Flutriafol; Time-Limited Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time-limited tolerance for residues of flutriafol *per se* in or on soybean. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizing use of the pesticide on soybean. This regulation establishes a maximum permissible level for residues of flutriafol *per se* in this food commodity. The tolerance will expire and is revoked on December 31, 2010. DATES: This regulation is effective August 29, 2007. Objections and requests for hearings must be received on or before October 29, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0327. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP 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: Princess Campbell, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-8033; e-mail address: *campbell.princess@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-2007-0327 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 October 29, 2007. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0327, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408
(e)and 408 (l)(6) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a 21 U.S.C. 346a, is establishing a time-limited tolerance for residues of the fungicide flutriafol *per se* in or on soybean at 0.10 parts per million (ppm). The tolerance will expire and is revoked on December 31, 2010. Section 408(l)(6) of the FFDCA allows EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408 (b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance or exemption from the requirement for a tolerance for pesticide (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” III. Emergency Exemption for Flutriafol on Soybeans and FFDCA Tolerances EPA has authorized under section 18 of FIFRA the use of flutriafol on soybeans for control of Australasian soybean rust initially in Minnesota and South Dakota and subsequently in multiple states. After having reviewed the submissions, EPA concurs that emergency conditions exist for these States. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of flutriafol *per se* in or on soybean seed. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with section 18 of FIFRA. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2010, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on soybean after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicates that the residues are not safe. Because this tolerance is being approved under emergency conditions EPA has not made any decisions about whether flutriafol meets EPA's registration requirements for use on soybeans or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of flutriafol by a State for special local needs under section 24(c) of FIFRA. Nor does this tolerance serve as the basis for any States other than those following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for flutriafol, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of flutriafol *per se* on soybean at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by flutriafol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found in the docket at *http://www.regulations.gov* , docket ID number EPA-HQ-OPP-2007-0327 (see memo from Tyler, *et al.* dated March 30, 2006). B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the 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, and estimates risk in terms of the probability of occurrence of additional cancer cases. Under certain specific circumstances, margin of exposure
(MOE)calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE <sup>cancer</sup> = point of departure/exposures) is calculated. A summary of the toxicological endpoints for flutriafol used for human risk assessment is shown as follows: **Table 1.—Summary of Toxicological Dose and Endpoints for flutriafol for Use in Human Risk Assessment** Exposure/Scenario Dose used in risk assessment, UF FQPA SF* and level of concern for risk assessment Study and toxicological effects Acute dietary (Females 13-50 years of age) NOAEL = < 10.0 millgrams/kilogram/day (mg/kg/day) UF = 1,000X Acute RfD = 0.01 mg/kg/day FQPA SF = 10X acute population adjusted dose
(aPAD)= acute Reference Dose
(RfD)Developmental toxicity - rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Acute dietary (General population including infants and children) NOAEL = Not applicable FQPA SF = Not applicable An endpoint of concern attributable to a single dose for general population was not identified Chronic dietary (All populations) NOAEL = < 10.0 mg/kg/day UF = 1,000X Chronic RfD = 0.01 mg/kg/day FQPA SF = 10X cPAD = chronic RfD Developmental toxicity-rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Short-term dermal (1 to 7 days) (Residential) Dermal (or oral) study NOAEL = < 10.0 mg/kg/day (Dermal absorption rate = 11.0%) LOC for MOE = 1,000 (residential) Developmental toxicity -rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Intermediate-term dermal (1 week to several months) (Residential) Dermal (or oral) study NOAEL = < 10.0 mg/kg/day (Dermal absorption rate = 11.0% LOC for MOE = 1,000 (residential) Developmental toxicity -rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Long-term dermal (Several months to lifetime) (Residential) Dermal (or oral) study NOAEL = < 10.0 mg/kg/day (Dermal absorption rate = 11.0% when appropriate) LOC for MOE = 1,000 (residential) Developmental toxicity -rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Short-term inhalation (1 to 7 days) (Residential) Inhalation (or oral) study NOAEL = < 10.0 mg/kg/day (Inhalation absorption rate = 100%) LOC for MOE = 1,000 (residential) Developmental toxicity -rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Intermediate-term inhalation (1 week to several months) (Residential) Inhalation (or oral) study NOAEL = < 10.0 mg/kg/day (Inhalation absorption rate = 100%) LOC for MOE = 1,000 (residential) Developmental toxicity - rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Long-term inhalation (several months to lifetime) (Residential) Inhalation (or oral) study NOAEL = < 10.0 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 1,000 (residential) Developmental toxicity -rat LOAEL = 10.0 mg/kg/day based on increased number of unossified odontoids, variations in occipitals and calcanea of hindlimbs and increased scores of m,anus and pes Cancer (oral, dermal, inhalation) NA. not carcinogenic to humans based on the lack of evidence for carcinogenicity in mice and rats NA NA * The reference to the FQPA SF refers to any additional safety factor retained. UF = uncertainty factor; FQPA SF = Special FQPA safety factor; NOAEL = no observed adverse effect level; LOAEL = lowest observed adverse effect level; PAD = population adjusted dose (a = acute, c = chronic); RfD = reference dose; MOE = margin of exposure; and LOC = level of concern. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Flutriafol is a new pesticide ingredient for the U.S. Therefore, there are no existing tolerances for flutriafol in 40 CFR part 180. Based on the available residue data on soybeans, residues of flutriafol are not expected to exceed 0.10 ppm on soybeans that have been treated in accordance with the emergency exemption use directions. Risk assessments were conducted by EPA to assess dietary exposures from flutriafol in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture
(USDA)Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An acute dietary exposure assessment was performed for females 13-49 years old using tolerance level residue, and 100 per cent treated
(PCT)information for all soybean commodities. Dietary Exposure and Risk Assessment, DP#322530, J. Tyler, 3/30/06. This assessment concludes that the acute dietary exposure estimates are below the Agency's level of concern ( < 100% aPAD) for the general U.S. population and all population subgroups. ii. *Chronic exposure* . In conducting this chronic dietary exposure and risk assessment the DEEM TM analysis evaluated the individual food consumption as reported by respondents in the USDA Nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic dietary exposure assessment was performed for the general U.S. population and various population subgroups using tolerance level residue, and 100% CT information for all soybean commodities. This assessment concludes that the chronic dietary exposure estimates are below the Agency's level of concern ( < 100% cPAD) for the general U.S. population and all population subgroups. The most highly exposed population subgroup is all infants ( < 1 year old) at 2.7% cPAD iii. *Cancer* . Preliminary analysis of tumor data indicated a significant increased trend in combined adenomas and carcinomas in male rat liver tumors. However, there were no significant differences noted in pair-wise comparison with controls in either male or female liver tumors. Thus, based on lack of evidence of carcinogenicity in both rats and mice carcinogenicity studies, the chemical was considered as “not likely” to be carcinogenic to humans. 2. *Dietary exposure from drinking water* . This emergency exemption use of flutriafol is the first use for this fungicide in the U.S. As such, there are no monitoring exposure data for water for this ingredient. Thus, in this risk assessment, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of flutriafol. 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* . The Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and (SCI-GROW) screening models were used to estimate surface water and ground water concentrations of flutriafol. Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations
(EECs)of flutriafol for acute exposures are estimated to be 4.0 μg/L for surface water and 2.0 μg/L for ground water. The EECs of flutriafol for chronic exposures are estimated to be 2.0 μg/L for surface water and 1.0 μg/L for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 4.0 μg/L was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.0 μg/L was used to assess the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flutriafol is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to flutriafol and any other substances Flutriafol is a member of the triazole-containing class of pesticides commonly referred to as the conazoles. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between their pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same, sequence of major biochemical events (EPA, 2002). In conazoles, however, a variable pattern of toxicological responses is found. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles produce a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to their toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at * http://www.epa.gov/pesticides/cumulative/.* Flutriafol is a triazole-derived pesticide. This class of compounds can form the common metabolite 1,2,4-triazole and two triazole conjugates (triazole alanine and triazole acetic acid). To support existing tolerances and to establish new tolerances for triazole-derivative pesticides. U.S. EPA conducted a human health risk assessment for exposure to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting from the use of all current and pending uses of any triazole-derived fungicide. The risk assessment is a highly conservative, screening-level evaluation in terms of hazards associated with common metabolites (e.g., use of a maximum combination of uncertainty factors) and potential dietary and non-dietary exposures (i.e., high end estimates of both dietary and non-dietary exposures). In addition, in assessing the risks for this group of chemicals the Agency retained the additional 10X FQPA safety factor for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those comprised of infants and children. The Agency's complete risk assessment for the conazole group is found in the propiconazole reregistration docket at *http://www.regulations.gov* , Docket ID Number EPA-HQ-OPP-2005-0497. D. Safety Factor for Infants and Children 1. * In general* . Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre-natal and post-natal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. *Pre-natal and post-natal sensitivity* . There is no evidence of increased susceptibility in the developmental study in rabbits or in the 2-generation reproduction study in the rat. Although some effects were seen in the rat developmental study, in the rat 2-generation reproduction toxicity study the effects occurred at the same dose that caused maternal toxicity indicating there was no increased susceptibility. These effects were considered to be study variations, and the Agency also retained the 10X safety factor to account for these variations due to the lack of a well defined NOAEL in the critical study. Therefore, there is no residual uncertainty for pre-natal and/or post-natal susceptibility. (See memo from Tyler, *et al* . dated March 30, 2006. 3. *Conclusion* . The Agency evaluated the quality of the hazard and exposure data and determined that based on the available hazard and exposure data, the FQPA SF should be retained. E. Aggregate Risks and Determination of Safety EPA conducted human-health risk assessments for acute and chronic dietary exposures (food and drinking water only). Because there are no uses of flutriafol that are expected to result in residential exposures, this aggregate risk assessment takes into consideration dietary food and drinking water exposure only. Therefore, the acute and chronic aggregate estimates would be the same as the dietary exposure results. All aggregate exposure and risk estimates are below EPA's level of concern. 1. *Acute risk* . Including the proposed use on soybeans, human-health risk assessments have been conducted for the following exposure scenarios: Acute and chronic dietary exposures (food and drinking water only). All aggregate exposure and risk estimates are below the Agency's level of concern. Because there are no uses of flutriafol that are expected to result in residential exposures, this aggregate risk assessment takes into consideration dietary food and drinking water exposure only. The acute (95 th percentile) dietary exposure estimates are below HED's level of concern < 100% aPAD for females 13-49 year old (10% aPAD). 2. *Chronic risk* . The chronic dietary exposures estimates are below HED's level of concern < 100% chronic population adjusted dose
(cPAD)for the general population and all population subgroups. The most highly-exposed population subgroup is all infants ( < 1 year old) at 2.7% 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). 4. *Aggregate cancer risk for U.S. population* . For this assessment, EPA has concluded that flutriafol is, “not likely to be carcinogenic 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 flutriafol residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method RAM 219/04) submitted by the registrant, (email from C. Rodia to J. Tyler, 3/23/06) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are currently tolerances of 0.10 ppm for soybean in Brazil and South Africa. V. Conclusion Therefore, the tolerance is established for residues of flutriafol, in or on soybean at 0.10 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 22, 2007. Martha Monell, Acting Director, Office 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 180.629 is added to read as follows: § 180.629 Flutriafol; tolerance for residues.
(a)*General* . [Reserved]
(b)*Section 18 emergency exemptions* . Time-limited tolerances specifed in the above table are established for residues of the fungicide flutriafol *per se* (2,4'-difluoro-α-(1H -1,2,4-triazol-1-yl-methyl)-benzhydryl alcohol) in or on the specified agricultural commodities, resulting from use of the pesticide pursuant to section 18 emergency exemptions. The tolerances expire and are revoked on the date specified in the following table. Parts per million Expiration/revocation date Soybean 0.10 December 31, 2010
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect or inadvertent residues* . [Reserved] [FR Doc. E7-17112 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HOMELAND SECURITY Coast Guard 46 CFR Parts 67 and 68 [USCG-2005-20258] RIN 1625-AA95 Vessel Documentation: Lease Financing for Vessels Engaged in the Coastwise Trade AGENCY: Coast Guard, DHS. ACTION: Final rule; announcement of effective date for collection of information requirements. SUMMARY: In the final rule with this same title published October 18, 2006, we noted that the Office of Management and Budget
(OMB)had not approved a collection-of-information associated with the amendments by §§ 68.65, 68.70, 68.75, 68.100, 68.107, and 68.109, to the collection-of-information requirements for vessel owners and charterers applying to engage in the coastwise trade under the lease financing provisions of 46 U.S.C. 12119 (formerly 46 U.S.C. 12106(e)). OMB has since approved that collection-of-information and the portions of the rule with these requirements are effective August 29, 2007. DATES: *Effective Date:* The amendments to 46 CFR 68.65, 68.70, 68.75, 68.100, 68.107, and 68.109, as published in the **Federal Register** on October 18, 2006 (71 FR 61413) are effective August 29, 2007. FOR FURTHER INFORMATION CONTACT: If you have questions on this document, call Patricia Williams, Deputy Director, National Vessel Documentation Center, U.S. Coast Guard, telephone 304-271-2506. If you have questions on viewing the docket (USCG-2005-20258), call Renee V. Wright, Program Manager, Docket Operations, telephone 202-493-0402. SUPPLEMENTARY INFORMATION: A final rule concerning applications to engage in the coastwise trade under the lease financing provisions of 46 U.S.C. 12119 became effective on November 17, 2006, with the exception of the collection of information requirements in the amendments to 46 CFR 68.65, 68.70, 68.75, 68.100, 68.107, and 68.109. Title 46 CFR 68.65 requires a vessel owner who seeks an initial, or renewal of, coastwise endorsement, to submit a certification of ownership in writing to the Director of the NVDC. 46 CFR 68.70 requires an owner of a vessel other than a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit a certified application for the coastwise operation of a vessel under a demise charter. 46 CFR 68.75 requires an owner of a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit certifications and documents supporting an application for the coastwise operation of a barge under a demise charter. 46 CFR 68.100 sets out applicability provisions and phase-in dates. 46 CFR 68.107 requires an owner of a vessel other than a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit certifications, certain supporting documents, and a certified application for the coastwise operation of a vessel under a demise charter. 46 CFR 68.109 requires an owner of a barge qualified to engage in coastwise trade under the lease financing provisions of 46 U.S.C. 12119 to submit certifications, certain supporting documents, and a certified application for the coastwise operation of a vessel under a demise charter. The final rule that contained the provisions for these certifications, supporting documents and applications was published in the **Federal Register** on October 18, 2006 (71 FR 61413), and is available electronically through the docket (USCG-2005-20258) at *http://dms.dot.gov/* . As required by 44 U.S.C. 3507(d), we submitted a copy of the final rule to OMB for its review. On January 10, 2007, after reviewing the rule, OMB approved the collection-of-information required in §§ 68.65, 68.70, 68.75, 68.100, 68.107, and 68.109 of the final rule under OMB control number 1625-0027. Dated: August 22, 2007. J.G. Lantz, Acting Assistant Commandant for Prevention, U.S. Coast Guard. [FR Doc. E7-17075 Filed 8-28-07; 8:45 am] BILLING CODE 4910-15-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-3556; MB Docket No. 07-79; RM-11362] Radio Broadcasting Service; Dinosaur, CO AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Audio Division grants a petition for rule making filed by Cumulus Licensing LLC (“Petitioner”) to allot Channel 262C0 at Dinosaur, Colorado. Channel 262C0 can be allotted at Dinosaur in compliance with the Commission's minimum distance separation requirements at 40-03-26 North Latitude and 108-39-46 West Longitude with a site restriction of 36.4 kilometers (22.6 miles) southeast of the community's reference. A filing window for Channel 262C0 at Dinosaur, Colorado will not be opened at this time. Instead, the issue of opening a filing window for this channel will be addressed by the Commission in a subsequent order. DATES: Effective September 24, 2007. ADDRESSES: Secretary, Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Helen McLean, Media Bureau,
(202)418-2738. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order,* MB Docket No. 07-79, adopted August 8, 2007, and released August 10, 2007. The full text of this Commission decision is available for inspection and copying during regular business hours at the FCC's Reference Information Center, Portals II, 445 Twelfth Street, SW., Room CY-A257, Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *www.BCPIWEB.com.* The Commission will send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Colorado, is amended by adding Dinosaur, Channel 262C0. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-17013 Filed 8-28-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 92 RIN 1018-AU59 Migratory Bird Subsistence Harvest in Alaska; Harvest Regulations for Migratory Birds in Alaska During the 2007 Season; Correction AGENCY: Fish and Wildlife Service, Interior. ACTION: Final rule; correction. SUMMARY: We, the Fish and Wildlife Service (Service), are correcting the DATES section of a final rule that appeared in the **Federal Register** of April 11, 2007 (72 FR 18317). The final rule published harvest regulations for migratory bird subsistence hunting in Alaska for the 2007 season. DATES: This correction is effective August 29, 2007. FOR FURTHER INFORMATION CONTACT: Fred Armstrong,
(907)786-3887, or Donna Dewhurst,
(907)786-3499, U.S. Fish and Wildlife Service, 1011 E. Tudor Road, Mail Stop 201, Anchorage, AK 99503. SUPPLEMENTARY INFORMATION: We published a final rule in the **Federal Register** of Wednesday, April 11, 2007 (72 FR 18317) that published harvest regulations for migratory bird subsistence hunting in Alaska for the 2007 season. In that rule, the DATES section incorrectly established an August 31, 2007, expiration date for amendments to subpart A of 50 CFR part 92. Subpart A of 50 CFR part 92 sets forth the general provisions for migratory bird subsistence harvest in Alaska, and we intended the amendments we made to subpart A of 50 CFR part 92 to be permanent. Therefore, in rule FR Doc. E7-6667 published on April 11, 2007 (72 FR 18318), make the following correction. On page 18318, in the first column, revise the DATES section to read: DATES: The amendments to subparts A and C of 50 CFR part 92 become effective May 11, 2007. The amendments to subpart D of 50 CFR part 92 are effective April 11, 2007, through August 31, 2007. Dated: August 23, 2007. Sara Prigan, Federal Register Liaison, Fish and Wildlife Service. [FR Doc. E7-17132 Filed 8-28-07; 8:45 am] BILLING CODE 4310-55-P 72 167 Wednesday, August 29, 2007 Proposed Rules NUCLEAR REGULATORY COMMISSION 10 CFR Part 2 [Docket No. PRM-2-14] State of Nevada; Receipt of Petition for Rulemaking AGENCY: Nuclear Regulatory Commission. ACTION: Petition for rulemaking; Notice of receipt. SUMMARY: The Nuclear Regulatory Commission
(NRC)has received and requests public comment on a petition for rulemaking filed by the State of Nevada (petitioner). The petition has been docketed by the NRC and has been assigned Docket No. PRM-2-14. The petitioner asserts that NRC will conduct a “mandatory” formal hearing if NRC dockets a Department of Energy
(DOE)application for a construction authorization for the proposed Yucca Mountain repository and requests that the NRC amend its regulations governing rules of practice in hearings by specifying the issues to be heard in this “mandatory” hearing. The petitioner believes an amendment is necessary because NRC's rules of practice currently only specify issues to be heard in mandatory hearings on nuclear reactor construction permits. DATES: Submit comments by November 13, 2007. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date. ADDRESSES: You may submit comments by any one of the following methods. Please include the following number PRM-2-14 in the subject line of your comments. Comments on petitions submitted in writing or in electronic form will be made available to the public in their entirety on the NRC rulemaking Web site. Personal information such as name, address, phone, e-mail address, etc., will not be removed from your submission. *Mail comments to:* Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Attention: Rulemaking and Adjudications staff. *E-mail comments to: SECY@nrc.gov.* If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at
(301)415-1966. You may also submit comments via the NRC's rulemaking Web site at *http://ruleforum.llnl.gov.* Address comments about our rulemaking Web site to Carol Gallagher,
(301)415-5905; (e-mail *cag@nrc.gov* ). Comments can also be submitted via the Federal eRulemaking Portal *http://www.regulations.gov.* *Hand deliver comments to:* 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm on Federal workdays. Publicly available documents related to this petition may be viewed electronically on the public computers located at the NRC Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents, including comments, may be viewed and downloaded electronically via the NRC rulemaking Web site at *http://ruleforum.llnl.gov.* Publicly available documents created or received at the NRC after November 1, 1999 are also available electronically at the NRC's Electronic Reading Room at *http://www.nrc.gov/reading-rm/adams.html.* From this site, the public can gain entry into the NRC's Agencywide Documents Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737 or by e-mail to *pdr@nrc.gov.* For a copy of the petition, write to Michael T. Lesar, Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone: 301-415-7163 or Toll-Free: 1-800-368-5642 or E-mail: *MTL@NRC.Gov.* SUPPLEMENTARY INFORMATION: Background The NRC has received a petition for rulemaking dated June 19, 2007, submitted by the State of Nevada (petitioner) entitled, “Petition by the State of Nevada for Rulemaking to Specify Issues for the Yucca Mountain Mandatory Hearing.” The petitioner requests that the NRC amend 10 CFR Part 2, which governs rules of practice for licensing proceedings. The petitioner notes that section 189a.(1)(A) of the Atomic Energy Act of 1954, as amended (AEA), requires a mandatory hearing for nuclear power reactor construction permits and that issues for these proceedings are specified by regulation. The petitioner asserts that in 1981 the Commission decided that there would be a “mandatory” formal adjudicatory hearing on any application for a construction authorization for the proposed Yucca Mountain repository but that the issues for that “mandatory” hearing are not specified by regulation. The petitioner states that it would be inappropriate for the Commission to delegate to the NRC staff the function of determining the issues in this hearing because the petitioner asserts the NRC staff will be an adversary party in the proceeding. The NRC has determined that the petition meets the threshold sufficiency requirements for a petition for rulemaking under 10 CFR 2.802. The petition has been docketed as PRM-2-14. The NRC is soliciting public comment on the petition for rulemaking. Discussion of the Petition The petitioner asserts that under section 161c. of the AEA, the NRC reserves the power to require a mandatory hearing even when the AEA does not require such a proceeding. The petitioner states that 10 CFR 2.104(a) provides for issuance of a notice of hearing when required by the AEA or the Commission's regulations, and when the NRC “finds that a hearing is required in the public interest.” The petitioner notes that the NRC developed procedures for licensing of a high-level waste
(HLW)repository during the early 1980s and published these procedures on February 25, 1981 (46 FR 13971). The petitioner asserts that these procedures include a requirement for a “mandatory hearing” at the repository construction authorization stage. The petitioner also asserts that, in 2004, when NRC revised its rules of practice, it reaffirmed the decision to hold a “mandatory,” formal hearing for an HLW repository. (See, 69 FR 2182, 2204; January 14, 2004.) The petitioner states that although 10 CFR 2.101(e)(8) requires that the notice of a “mandatory” hearing on a repository construction authorization “shall recite the matters specified in § 2.104(a) of this part,” § 2.104(a) does not specify the matters of fact or law to be considered. The petitioner contrasts this provision with the notices of mandatory hearings for nuclear power reactors under § 2.104(b) that require the presiding officer to consider the evidence and make all safety and environmental findings required for issuance of the license, and to determine if the NRC staff's review of the application was adequate. The petitioner asserts this has resulted in a “regulatory gap” in the NRC's rules of practice. The petitioner is concerned that the scope of issues to be considered must extend beyond admitted contentions “because otherwise the decision to hold a mandatory hearing would be nothing more than an empty gesture.” The petitioner states that its proposed amendment is patterned after § 2.104(b) but notes that this provision currently applies only to nuclear power reactor proceedings. The petitioner believes that the recent notices of hearing for uranium enrichment facilities such as in the USEC, Inc. (American Centrifuge Plant), CLI-04-30, 60 NRC 426
(2004)proceeding offer an easier template to follow for a hearing. The petitioner also states that because there is no reason to distinguish the “mandatory” hearing for Yucca Mountain from the “mandatory” hearing for other HLW repositories subject to 10 CFR Part 60, its suggested amendments would apply to repository facilities subject to either Part 60 or Part 63. The Petitioner's Proposed Amendment The petitioner requests that 10 CFR 2.101(e)(8) be amended by deleting the reference to § 2.104(a) and replacing it with a reference to § 2.104(f). The petitioner also requests that § 2.104 be amended by adding a new paragraph
(f)to read as follows: (f)(1) In the case of an application for a construction authorization for a high-level waste repository under parts 60 or 63 of this chapter, the notice of hearing will state that the matters of fact and law to be considered are whether the application complies with the Nuclear Waste Policy Act of 1982, as amended, and the standards set forth in 10 CFR 60.10, 60.21, and 60.24(a), or 10 CFR 63.10, 63.21, and 63.24(a), as applicable, and whether the requirements of 10 CFR 60.31 or 10 CFR 63.31, as applicable, have been met.
(2)Regardless of whether the proceeding is contested or uncontested, the Atomic Safety and Licensing Board will determine the following, without conducting a de novo review of the application:
(i)Whether the application and record of the proceeding contain sufficient information, and whether the NRC staff's review of the application has been adequate, to support findings to be made by the Director of the Office of Nuclear Materials Safety and Safeguards with respect to the matters set forth in paragraph (f)(1) of this section; and
(ii)Whether the review conducted by the NRC Staff under 10 CFR part 51 has been adequate.
(3)Regardless of whether the proceeding is contested or uncontested, the Atomic Safety and Licensing Board will, in its initial decision, under Subpart A of 10 CFR part 51, and the Nuclear Waste Policy Act of 1982, as amended:
(i)Determine whether the requirements of section 102(2)(A), (C), and
(D)of NEPA, section 114(f) of the Nuclear Waste Policy Act of 1982, as amended, and subpart A of 10 CFR part 51 have been complied with in the proceeding;
(ii)Independently consider the final balance among conflicting factors contained in the record of the proceeding with a view to determining the appropriate action to be taken; and
(iii)Determine whether the authorization should be issued, denied, or further conditioned to protect the environment.
(4)If the proceeding becomes a contested proceeding, the Board shall also make findings of fact and conclusions of law on admitted contentions within the scope of paragraphs (f)(1), (2), and
(3)of this section. With respect to matters set forth in paragraph (f)(1) of this section but not covered by admitted contentions, the Atomic Safety and Licensing Board will make the determinations set forth in paragraph (f)(2) of this section without conducting a de novo evaluation of the application. Lastly, the petitioner requests that 10 CFR 2.700 be amended by deleting “2.101(f)(8)” and replacing it with “2.104(f).” The petitioner states that its proposed § 2.104(f)(2) would apply to both contested and uncontested proceedings. The petitioner explains that the safety findings required by this proposed amendment focus on the adequacy of the record of the proceeding, the license application, and the NRC staff's review. The petitioner states that limiting these findings to uncontested cases, as it believes was the NRC's prior practice, implies that these findings are irrelevant in litigating contested issues. However, the petitioner states that litigation and findings on contested issues necessarily include findings on the adequacy of the record, the application, and the NRC staff's review, insofar as these are relevant to contested issues. The petitioner also explains that proposed 2.104(f)(1) and
(3)reference the Nuclear Waste Policy Act of 1982, as amended (NWPA), “for completeness” and because of the National Environmental Policy Act provision in section 114(f) of the NWPA. Lastly, the petitioner explains that proposed § 2.104(f)(4) includes a specific reference to paragraphs (f)(1)-(f)(3) of that section for clarity because these provisions define the scope of material issues that may be litigated. The petitioner requests that the NRC act expeditiously on these proposed amendments to 10 CFR Part 2 as detailed in this petition for rulemaking because the DOE intends to file a construction authorization license application for the Yucca Mountain facility with the NRC no later than June 30, 2008. Dated at Rockville, Maryland, this 23rd day of August 2007. For the Nuclear Regulatory Commission. Annette L. Vietti-Cook, Secretary of the Commission. [FR Doc. E7-17106 Filed 8-28-07; 8:45 am] BILLING CODE 7590-01-P SMALL BUSINESS ADMINISTRATION 13 CFR Part 121 RIN 3245-AF68 Small Business Size Standards; Adoption of 2007 North American Industry Classification System for Size Standards AGENCY: Small Business Administration. ACTION: Proposed rule. SUMMARY: The U.S. Small Business Administration
(SBA)proposes to amend its Small Business Size Regulations by incorporating the Office of Management and Budget's
(OMB)2007 modifications to the North American Industry Classification System (NAICS) in its table of small business size standards. These modifications are few in number and result in revisions to size standards for three industries and four activities within other industries. SBA believes that this proposal is routine and non-controversial, and the Agency anticipates no significant adverse comment. Therefore, SBA is publishing concurrently in this issue of the **Federal Register** a direct final rule to expedite modifying its Small Business Size Regulations as described in this proposed rule. If SBA receives any significant adverse comment to the direct final rule, it will withdraw it, and consider those comments in connection with this proposed rule. DATES: SBA must receive comments to this proposed rule on or before September 28, 2007. ADDRESSES: You may submit comments, identified by RIN 3245-AF68, by any of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *Mail, for paper, disk, or CD/ROM submissions:* Gary M. Jackson, Division Chief for Size Standards, 409 Third Street, SW., Mail Code 6530, Washington, DC 20416. • *Hand Delivery/Courier:* Gary M. Jackson, Division Chief for Size Standards, 409 Third Street, SW., Mail Code 6530, Washington, DC 20416. SBA will post all comments on *www.regulations.gov.* If you wish to submit confidential business information
(CBI)as defined in the User Notice at *www.regulations.gov,* please submit the information to Carl J. Jordan, Office of Size Standards, 409 Third Street, SW., Mail Code 6530, Washington, DC 20416, or send an email to *sizestandards@sba.gov.* Highlight the information that you consider to be CBI and explain why you believe SBA should hold this information as confidential. SBA will review the information and make the final determination of whether it will publish the information or not. FOR FURTHER INFORMATION CONTACT: Carl Jordan, Office of Size Standards, at
(202)205-6618 or *sizestandards@sba.gov.* SUPPLEMENTARY INFORMATION: SBA adopted the NAICS industry definitions as a basis for its table of small business size standards effective October 1, 2000, as a replacement to the discontinued Standard Industrial Classification
(SIC)System (65 FR 30836, May 15, 2000). Since that time, OMB has issued two updates modifying the NAICS. SBA incorporated OMB's first updated modifications, termed NAICS 2002 (66 FR 3825, January 16, 2001), in its table of size standards effective October 1, 2002 (67 FR 52597, August 13, 2002). OMB published its most recent updates, termed NAICS 2007, on May 16, 2006 (71 FR 28532). SBA is proposing adoption of those updated modifications in its table of small business size standards, as explained below. For complete information on the relationship between NAICS 2002 and NAICS 2007, please see the U.S. Bureau of the Census (Census Bureau) Web site at *http://www.census.gov/epcd/www/naicsdoc.htm#fedreg.* That Census Bureau Web site provides complete information on its establishment and implementation of NAICS 2007, including its notice of final action in the March 16, 2006 **Federal Register** . The Census Bureau also provides the following correspondence tables:
(1)2007 NAICS-US matched to 2002 NAICS-US; and
(2)2002 NAICS-US matched to 2007 NAICS-US. How SBA Arrived at the Size Standards for NAICS 2007 Industries On October 22, 1999, SBA published in the **Federal Register** (64 FR 57188) a proposed rule to establish a new table of small business size standards based on the NAICS. SBA developed guidelines to transition from the SIC System to NAICS. The guidelines were intended to minimize the impact of a new industry classification system on SBA's small business size standards. Table 1, below, lists those guidelines. SBA received no negative comments to the guidelines specified in the proposed rule. Because the guidelines produced the desired results and received public acceptance, SBA published a final rule on May 5, 2000 (65 FR 3825) (corrected on September 5, 2000, 65 FR 53533) establishing a new table of size standards based on NAICS without change from its proposed rule. For purposes of adopting NAICS 2007, SBA is proposing to apply the same guidelines in this rule. Table 1 If the NAICS 2007 Industry is composed of: The size standard for the NAICS Industry will be: 1. One NAICS 2002 industry or part of one NAICS 2002 industry The same size standard as for the NAICS 2002 industry or part. 2. More than one NAICS 2002 industry; parts of more than one NAICS 2002 industry; or one or more NAICS 2002 industry and part(s) of one or more NAICS 2002 industry, *and* they all have the same size standard The same size standard as for those NAICS 2002 industries or parts of NAICS 2002 industries. 3. More than one NAICS 2002 industry; parts of more than one NAICS 2002 industry; or one or more NAICS 2002 industry and part(s) of one or more NAICS 2002 industry, *and* they do not all have the same size standard The same size standard as for the NAICS 2002 industry or NAICS 2002 industry part(s) that most closely matches the economic activity described by the NAICS 2007 industry. 4. One or more parts of an NAICS 2002 industry for which SBA has established specific size standards ( *i.e.* , further segmented) The same size standard as for that specific NAICS 2002 industry part. 5. One or more NAICS 2002 industries and/or parts of NAICS 2002 industries that were categorized broadly under the NAICS system as Services, Retail Trade, Wholesale Trade or Manufacturing, but are now categorized differently under NAICS SBA will
(a)apply a size standard measure ( *e.g.* , number of employees, annual receipts) typical of the NAICS Sector; and
(b)apply the corresponding “anchor” size standard. The “anchor” size standards are $6.5 million (effective December 6, 2005) for Services and Retail Trade, 500 employees for Manufacturing and 100 employees for Wholesale Trade (except for Federal procurement programs, where the standard is 500 employees under the non-manufacturer rule). Additions to and Deletions From NAICS 2002 for NAICS 2007 It is important to note the following: 1. NAICS 2007 changes affect 59 NAICS 2002 industries. 2. One NAICS 2002 Subsector and 12 NAICS 2002 industries were eliminated and their activities reclassified in other more appropriate or new NAICS 2007 industries as listed in Table 2: Table 2 NAICS 2002 code NAICS 2002 industry description NAICS 339111 Laboratory Apparatus and Furniture Manufacturing. Subsector 516 Internet Publishing and Broadcasting. NAICS 516110 Internet Publishing and Broadcasting. NAICS 517211 Paging. NAICS 517212 Cellular and Other Wireless Telecommunications. NAICS 517310 Telecommunications Resellers. NAICS 517510 Cable and Other Program Distribution. NAICS 517910 Other Telecommunications. NAICS 518111 Internet Service Providers. NAICS 518112 Web Search Portals. NAICS 525930 Real Estate Investment Trusts. NAICS 541710 Research and Development in the Physical, Engineering, and Life Sciences. NAICS 561310 Employment Placement Agencies. 3. The following eight industries listed in Table 3 are new in NAICS 2007: Table 3 NAICS 2007 code NAICS 2007 industry description NAICS 517210 Wireless Telecommunications Carriers (except Satellite). NAICS 517911 Telecommunications Resellers. NAICS 517919 All Other Telecommunications. NAICS 519130 Internet Publishing and Broadcasting and Web Search Portals. NAICS 541711 Research and Development in Biotechnology. NAICS 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology). NAICS 561311 Employment Placement Agencies. NAICS 561312 Executive Search Services. Changes in Size Standards Resulting From SBA's Proposed Adoption of NAICS 2007 Most of the industries in NAICS 2002 remain unchanged under NAICS 2007. This proposal to adopt NAICS 2007 will change size standards for only three industries and four activities from parts of industries. Other changes in NAICS 2007 consist of revised industry descriptions or the reclassification of industry activities in other industries having the same size standard. Table 4 lists all of OMB's modifications to the NAICS 2002 industries. The first three columns show the modified NAICS 2002 industry's six-digit code, its current size standard, and its industry description. The last three columns show the NAICS 2007 industry (new, existing and revised) that incorporates the modified NAICS 2002 industry, its industry description, and new size standard. By comparing the modified NAICS 2002 industry and size standard with the related NAICS 2007 industry and size standard, a user can identify the size standard SBA proposes for the applicable NAICS 2007 industries. Following Table 4, SBA explains the basis for the limited number of cases that do result in a change to the size standard. Table 4.—This Table Includes Only Those NAICS Codes Where Size Standards Are Affected. They Are Arranged According to the Order of Their NAICS 2007 Industry Codes 2002 NAICS code Current size standards 2002 NAICS U.S. description 2007 NAICS code 2007 NAICS U.S. description New size standards 111211 $0.75 million Potato Farming. *111219 $0.75 million Other Vegetable (except Potato) and Melon Farming— *sweet potato and yam farming* 111211 Potato Farming $0.75 million. *111219 $0.75 million Other Vegetable (except Potato) and Melon Farming— *except sweet potato and yam farming* 111219 Other Vegetable (except Potato) and Melon Farming $0.75 million. *111998 $0.75 million All Other Miscellaneous Crop Farming— *except algae, seaweed, and other plant aquaculture* 111998 All Other Miscellaneous Crop Farming $0.75 million. 112519 $0.75 million Other Animal Aquaculture. *111998 $0.75 million All Other Miscellaneous Crop Farming— *algae, seaweed, and other plant aquaculture* 112519 Other Aquaculture $0.75 million. 314999 500 employees All Other Miscellaneous Textile Product Mills. *315211 500 employees Men's and Boys' Cut and Sew Apparel Contractors— *embroidery contractors.* *315212 500 employees Women's, Girls' and Infants' Cut and Sew Apparel Contractors— *embroidery contractors* 314999 All Other Miscellaneous Textile Product Mills 500 employees. *315211 500 employees Men's and Boys' Cut and Sew Apparel Contractors— *except embroidery contractors* 315211 Men's and Boys' Cut and Sew Apparel Contractors 500 employees. *315212 500 employees Women's, Girls' and Infants' Cut and Sew Apparel Contractors— *except embroidery contractors* 315212 Women's, Girls' and Infants' Cut and Sew Apparel Contractors 500 employees. *326199 500 employees All Other Plastics Product Manufacturing— *except inflatable plastic boats* 326199 All Other Plastics Product Manufacturing 500 employees. *326291 500 employees Rubber Product Manufacturing for Mechanical Use— *except rubber tubing for mechanical use* 326291 Rubber Product Manufacturing for Mechanical Use 500 employees. *326299 500 employees All Other Rubber Product Manufacturing— *except inflatable rubber boats.* *326291 500 employees Rubber Product Manufacturing for Mechanical Use— *rubber tubing for mechanical use* 326299 All Other Rubber Product Manufacturing 500 employees. 333298 500 employees All Other Industrial Machinery Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory distilling equipment* 333298 All Other Industrial Machinery Manufacturing 500 employees. 333415 750 employees Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory freezers* 333415 Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing 750 employees. 333994 500 employees Industrial Process Furnace and Oven Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory furnaces and ovens* 333994 Industrial Process Furnace and Oven Manufacturing 500 employees. 333997 500 employees Scale and Balance (except Laboratory) Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory scales and balances* 333997 Scale and Balance Manufacturing 500 employees. 333999 500 employees All Other Miscellaneous General Purpose Machinery Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory centrifuges* 333999 All Other Miscellaneous General Purpose Machinery Manufacturing 500 employees. *334220 750 employees Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing— *except communications signal testing and evaluation equipment* 334220 Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing 750 employees. 334515 500 employees Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals. *334220 750 employees Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing— *communications signal testing and evaluation equipment* 334515 Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals 500 employees. 336612 500 employees Boat Building. *326199 500 employees All Other Plastics Product Manufacturing— *inflatable plastics boats.* *326299 500 employees All Other Rubber Product Manufacturing— *inflatable rubber boats* 336612 Boat Building 500 employees. 337127 500 employees Institutional Furniture Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *laboratory furniture (e.g., stools, tables, benches)* 337127 Institutional Furniture Manufacturing 500 employees. 339113 500 employees Surgical Appliance and Supplies Manufacturing. *339111 500 employees Laboratory Apparatus and Furniture Manufacturing— *except laboratory furniture, scales, balances, furnaces, ovens, centrifuges, distilling equipment, and freezers* 339113 Surgical Appliance and Supplies Manufacturing 500 employees. 517110 1500 employees Wired Telecommunications Carriers. 517510 $13.5 million Cable and Other Program Distribution. *518111 $23.0 million Internet Service Providers— *broadband Internet service providers (e.g., cable, DSL)* 517110 Wired Telecommunications Carriers 1500 employees. 517211 1500 employees Paging. 517212 1500 employees Cellular and Other Wireless Telecommunications 517210 Wireless Telecommunications Carriers (except Satellite) 1500 employees. 517310 1500 employees Telecommunications Resellers 517911 Telecommunications Resellers 1500 employees. 517910 $13.5 million Other Telecommunications 517919 All Other Telecommunications $23.0 million. *518111 $23.0 million Internet Service Providers *ISPs providing services via client-supplied telecommunications connections.* 516110 500 employees Internet Publishing and Broadcasting 519130 Internet Publishing and Broadcasting and Web Search Portals 500 employees. 518112 $6.5 million Web Search Portals. 519190 $6.5 million All Other Information Services 519190 All Other Information Services $6.5 million. 525990 $6.5 million Other Financial Vehicles. *525930 $6.5 million Real Estate Investment Trusts— *hybrid or mortgage REITs primarily in underwriting or investing in mortgages* 525990 Other Financial Vehicles $6.5 million. 531110 $6.5 million Lessors of Residential Buildings and Dwellings. *525930 $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing residential Buildings and Dwellings* 531110 Lessors of Residential Buildings and Dwellings $6.5 million. 531120 $6.5 million Lessors of Nonresidential Buildings (except Miniwarehouses). *525930 $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing nonresidential buildings* 531120 Lessors of Nonresidential Buildings (except Miniwarehouses) $6.5 million. 531130 $23.5 million Lessors of Miniwarehouses and Self-Storage Units. *525930 $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing miniwarehouses and self-storage units* 531130 Lessors of Miniwarehouses and Self-Storage Units $23.5 million. 531190 $6.5 million Lessors of Other Real Estate Property. *525930 $6.5 million Real Estate Investment Trusts— *hybrid or equity REITs primarily leasing other real estate property* 531190 Lessors of Other Real Estate Property $6.5 million. *541612 $6.5 million Human Resources and Executive Search Consulting Services— *except executive search consulting services* 541612 Human Resources Consulting Services $6.5 million. *541710 500 employees Research and Development in the Physical, Engineering, and Life Sciences— *biotechnology research and development* 541711 Research and Development in Biotechnology 500 employees. *541710 500 employees Research and Development in the Physical, Engineering, and Life Sciences— *except biotechnology research and development* 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) 500 employees. 561310 $6.5 million Employment Placement Agencies 561311 Employment Placement Agencies. $6.5 million. *541612 $6.5 million Human Resources and Executive Search Consulting Services— *executive search consulting services* 561312 Executive Search Services $6.5 million. * Indicates that this activity within the identified NAICS 2002 code is now an activity within the related NAICS 2007 industry. As shown in Table 4, the NAICS 2007 modifications lead to a proposed revision to the current size standard for a limited number of industries or activities. The basis for the revisions to seven size standards are discussed below: 1. NAICS 339111, “Laboratory Apparatus and Furniture Manufacturing,”
(part)*laboratory freezers.* NAICS 2007 eliminated NAICS 339111. The various activities of NAICS 339111 are reclassified in other NAICS 2007 codes having the same 500 employee size standard, except for laboratory freezer manufacturing. Laboratory freezer manufacturing is reclassified in NAICS 333415, “Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing,” having a size standard of 750 employees. SBA proposes to retain the 750 employee size standard for NAICS 333415 because laboratory freezer manufacturing represents a small part of that industry (Rule #3). 2. NAICS 334220, “Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing,”
(part)*communications signal testing and evaluation equipment.* The current size standard for NAICS 334220 is 750 employees. The activity of “communications signal testing and evaluation equipment manufacturing” in NAICS 2007 is reclassified in NAICS 334515, “Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals,” having a size standard of 500 employees. SBA proposes to retain the 500 employee size standard for NAICS 334515 because “communications signal testing and evaluation equipment manufacturing” represents a small part of that industry (Rule #3). 3. NAICS 518111, “Internet Service Providers,”
(part)*broadband Internet service providers (e.g., cable, DSL* ). The current size standard for NAICS 518111 is $23.0 million in average annual receipts. The activity, “broadband Internet services providers ( *e.g.* , cable, DSL),” in NAICS 2007 is reclassified in NAICS 517110, “Wired Telecommunications Carriers,” having a 1,500 employee size standard. SBA proposes to retain the 1,500 employee size standard for NAICS 517110 because broadband Internet services providers represent a small part of that industry (Rule #3). 4. NAICS 517510, “Cable and Other Program Distribution.” NAICS 2007 eliminated NAICS 517510. The current size standard for NAICS 517510 is $13.5 million in average annual receipts. In NAICS 2007, all activities of NAICS 517510 are reclassified in 517110, “Wired Telecommunications Carriers,” having a 1,500 employee size standard. SBA proposes to apply the 1,500 employee size standard for NAICS 517110 because the Cable and Other Program Distribution industry is much smaller than the Wired Telecommunications Carriers industry (Rule #3). 5. NAICS 517910, “Other Telecommunications.” NAICS 2007 eliminated NAICS 517910. NAICS 2007 establishes a new industry titled “All Other Telecommunications,” NAICS 517919, comprising all activities of NAICS 517910 having a size standard of $13.5 million and most activities from NAICS 518111, “Internet Service Providers (ISP),” having a size standard of $23 million. As discussed in # 3 above, the activity of “broadband Internet services providers” in NAICS 518111 is reclassified in NAICS 517110. SBA proposes to apply the $23 million size standard for that industry because ISP establishments providing services via client-supplied telecommunications connections represent the larger component of the new NAICS 517919 (Rule #3). 6. NAICS 518112, “Web Search Portals.” NAICS 2007 eliminated NAICS 518112 and NAICS 516110, “Internet Publishing and Broadcasting,” having size standards of $6.5 million and 500 employees, respectively. NAICS 2007 combines these two industries to form a new six-digit industry—NAICS 519130, “Internet Publishing and Broadcasting and Web Search Portals.” SBA proposes to apply the 500 employee size standard for NAICS 519130 because the Internet Publishing and Broadcasting industry is much larger than the Web Search Portals industry (Rule #3). 7. NAICS 525930, “Real Estate Investment Trusts,”
(part)*hybrid or equity REITs primarily leasing miniwarehouses and self-storage units.* NAICS 2007 eliminated NAICS 525930. The various activities of NAICS 525930 are reclassified in NAICS 2007 codes having the same $6.5 million size standard, except for the activity of hybrid or equity REITs primarily leasing miniwarehouses and self-storage units. That activity is reclassified in NAICS 531130, “Lessors of Miniwarehouses and Self-Storage Units,” having a $23.5 million size standard. SBA proposes to retain the $23.5 million size standard for NAICS 531130 because hybrid or equity REITs primarily leasing miniwarehouses and self-storage units represent a small part of that industry (Rule #3). Alternatives to Adopting NAICS 2007 That SBA Considered SBA considered retaining the NAICS 2002 codes as the basis for small business size standards. However, SBA believes that doing so will lead to inconsistency among Federal agencies that adopt NAICS 2007 for their programs. More importantly, if SBA does not adopt NAICS 2007 it will not be able to analyze and evaluate small business size standards adequately because available Census Bureau data based on NAICS 2007 industries will not be comparable with NAICS 2002 industry data. Without useful data, SBA cannot properly analyze size standards and their effects on businesses. SBA considered segmenting the modified NAICS 2002 size standard for cases where the size standard changes instead of applying the guidelines used in previous NAICS revisions. SBA believes this alternative is impractical because it would complicate size standards for minor reasons. Furthermore, the application of the guidelines for NAICS 2007 results in the loss of eligibility for currently-defined small businesses in only one minor industry activity. That occurs for “communications signal testing and evaluation equipment manufacturing,” a part of NAICS 334220, “Radio and Television Broadcasting and Wireless Communications Equipment Manufacturing.” The size standard for that activity decreases from 750 employees to 500 employees. A search of the Dynamic Small Business Search
(DSBS)reveals that there are 38 small businesses out of 2,200 small businesses registered in NAICS 334220 having more than 500 employees. However, it is unlikely that many of these businesses, if any, will be affected given the limited activity of “communications signal testing and evaluation equipment manufacturing.” All other activities in NAICS 334220 will continue to have a size standard of 750 employees. Consideration of Comments SBA will take in account all submitted comments on this proposed rule and on the alternatives it considered. SBA believes that this proposal is routine and non-controversial. Therefore, SBA is publishing concurrently in this issue of the **Federal Register** a direct final rule to expedite modifying its size standards as explained in this proposed rule. If SBA decides to adopt NAICS 2007 as proposed, or with limited modifications, it will publish a final rule that addresses the comments and explains the basis for its final decision. Compliance With Executive Orders 12866, 12988, and 13132, the Paperwork Reduction Act (44 U.S.C. Ch. 35.) and the Regulatory Flexibility Act (5 U.S.C. 601-612) OMB has determined that this proposed rule is not a “significant” regulatory action for purposes of Executive Order (E.O.) 12866. This proposed rule incorporates the latest revisions of the NAICS, which SBA uses to identify industries in the United States economy for purposes of establishing small business size standards. As discussed in the preamble, the size standard of a limited number of activities would change because of the NAICS revisions. Almost all businesses currently defined as small under the NAICS 2002 industries would continue to be small under the NAICS 2007 industries, if adopted for size standards. The rule also affects Federal Government programs that provide a benefit for small businesses. SBA welcomes comments describing the impact on small businesses of the size standard changes resulting from this rule. For purposes of E.O. 12988, SBA has determined that this rule is drafted, to the extent practicable, in accordance with the standards set forth in that order. For purposes of E.O. 13132, SBA has determined that this rule does not have any federalism implications warranting the preparation of a Federalism Assessment. For purposes of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this rule does not impose any new reporting or recordkeeping requirements. When an agency promulgates a proposed rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) requires the agency to prepare an initial regulatory flexibility analysis
(IRFA)describing the potential economic impact of the rule on small entities and alternatives that may minimize that impact. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an IRFA, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. SBA has determined that this proposed rule as drafted, including the alternatives discussed in the supplementary information above, will not have a significant impact on a substantial number of small entities. OMB's NAICS 2007 modifications will result in size standards changes to a minimal number of activities within certain industries detailed above in the supplementary information, with little, if any, affect on small businesses. Those activities are now part of other, more appropriate or new NAICS codes and their industry descriptions. There will be no changes to the size standards for most NAICS industries and their economic activities. For those that would change, they would create a larger number of enterprises that can qualify for Federal government programs reserved for small businesses. As stated above, a search of the Dynamic Small Business Search
(DSBS)reveals that there are 38 small businesses out of 2,200 small businesses registered in NAICS 334220 having more than 500 employees. However, it is unlikely that many of these businesses, if any, will be affected given the limited activity of “communications signal testing and evaluation equipment manufacturing.” All other activities in NAICS 334220 will continue to have a size standard of 750 employees. Therefore, SBA believes that the impact on small businesses will be minimal because these activities represent relatively minor components of the NAICS 2002 industries. When SBA published a direct final rule to replace the table of small business size standards based on NAICS 1997 with a new one based on NAICS 2002, it certified that for purposes of the Regulatory Flexibility Act, the rule would affect a significant number of small businesses, but that the impact on each business would not be substantial. (67 FR 52597 to 52606, 62292, 67253 and 67102) SBA received no comments to the contrary. No changes have occurred since then. Adopting NAICS 2007 to replace NAICS 2002 as the basis for its table of size standards would have, SBA believes, an even smaller impact. List of Subjects in 13 CFR Part 121 Administrative practice and procedure, Government procurement, Government property, Grant programs—business, Individuals with disabilities, Loan programs—business, Reporting and recordkeeping requirements, Small businesses. For the reasons set forth in the preamble, SBA proposes to amend 13 CFR part 121 as follows: PART 121—SMALL BUSINESS SIZE REGULATIONS 1. The authority citation for part 121 continues to read as follows: Authority: 15 U.S.C. 632, 634(b)(6), 636(b), 637(a), 644, and 662(5); and Pub. L. 105-135, Sec. 401, *et seq.* , 111 Stat. 2592. § 121.201 [Amended] 2. Amend § 121.201, in the table “Small Business Size Standards by NAICS Industry,” as follows: a. Revise the industry description of NAICS code 112519 “Other Animal Aquaculture” to read “Other Aquaculture.” b. Revise the heading “Sector 21—Mining” to read “Sector 21—Mining, Quarrying, and Oil and Gas Extraction.” c. Revise the industry description of NAICS code 238210, “Electrical Contractors,” to read “Electrical Contractors and other Wiring Installation Contractors.” d. Revise the industry description of NAICS code 316999, “All Other Leather Good Manufacturing,” to read “All Other Leather Good and Allied Product Manufacturing.” e. Revise the industry description of NAICS code 322221, “Coated and Laminated Packaging Paper and Plastics Film Manufacturing,” to read “Coated and Laminated Packaging Paper Manufacturing.” f. Revise the industry description of NAICS code 326111, “Unsupported Plastics Bag Manufacturing,” to read “Plastics Bag and Pouch Manufacturing.” g. Revise the industry description of NAICS code 333997, “Scale and Balance (except Laboratory) Manufacturing,” to read “Scale and Balance Manufacturing.” h. Remove the entry NAICS code 339111, “Laboratory Apparatus and Furniture Manufacturing.” i. Revise the industry description of NAICS code 441221, “Motorcycle Dealers,” to read “Motorcycle, ATV, and Personal Watercraft Dealers.” j. Revise the heading “Sectors 48—49—Transportation” to read “Sectors 48—49—Transportation and Warehousing.” k. Revise the industry description of NAICS code 492110, “Couriers,” to read “Couriers and Express Delivery Services.” l. Remove the heading “Subsector 516—Internet Publishing and Broadcasting” and the entry for NAICS code 516110, “Internet Publishing and Broadcasting.” m. Remove the entries for NAICS codes 517211, “Paging;” 517212, “Cellular and Wireless Telecommunications;” and, 517310 “Telecommunications Resellers” and add in their place the following: 517210 Wireless Telecommunications Carriers (except Satellite) 1,500 n. Remove the entries for NAICS codes 517510, “Cable and Other Program Distribution,” and 517910, “Other Telecommunications,” and add in their place the following: 517911 Telecommunications Resellers 1,500 517919 All Other Telecommunications $23.5 o. Revise the heading “Subsector 518—Internet Service Providers, Web Search Portals, and Data Processing Services” to read “Subsector 518—Data Processing, Hosting, and Related Services.” p. Remove the entries for NAICS codes 518111, “Internet Service Providers,” and 518112, “Web Search Portals”. q. Add immediately after entry for NAICS code 519120, “ Libraries and Archives” the following: 519130 Internet Publishing and Broadcasting and Web Search Portals 500 r. Revise the heading “Subsector 523—Financial Investments and Related Activities” to read “Subsector 523—Securities, Commodity Contracts, and Other Financial Investments and Related Activities.” s. Revise the industry description of NAICS code 541612, “Human Resources and Executive Search Consulting Services,” to read “Human Resources Consulting Services.” t. Remove the entry NAICS code 541710, “Research and Development in the Physical, Engineering, and Life Sciences,” and add in its place the following: 541711 Research and Development in Biotechnology 11 11 500 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) 11 11 500 *Except,* Aircraft 1,500 *Except,* Aircraft Parts, and Auxiliary Equipment, and Aircraft Engine Parts 1,000 *Except,* Space Vehicles and Guided Missiles, their Propulsion Units, their Propulsion Units Parts, and their Auxiliary Equipment and Parts 1,000 u. Remove the entry for NAICS code 561310, “Employment Placement Agencies,” and add in its place the following: 561311 Employment Placement Agencies $6.5 561312 Executive Search Services 6.5 v. Revise the industry description of NAICS code 561422, “Telemarketing Bureaus,” to read “Telemarketing Bureaus and Other Contact Centers.” w. Revise the industry description of NAICS code 722212, “Cafeterias,” to read “Cafeterias, Grill Buffets, and Buffets.” x. Revise the heading “Sector 81—Other Services” to read “Sector 81—Other Services (except Public Administration).” y. Amend footnote 11 by removing “ *NAICS code 541710* ” and adding in its place “ *NAICS codes 541711 and 541712* .” Dated: August 23, 2007. Steven C. Preston, Administrator. [FR Doc. E7-17150 Filed 8-28-07; 8:45 am] BILLING CODE 8025-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2007-28529; Airspace Docket No. 07-ANM-12] Proposed Modification of Class E Airspace; Tucson, AZ AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking. SUMMARY: This action proposes to modify Class E airspace at Tucson, AZ. Additional controlled airspace is necessary to encompass holding patterns and intermediate segments at Tucson International Airport. The FAA is proposing this action to enhance the safety and management of Instrument Flight Rules
(IFR)operations at Tucson International Airport, Tucson, AZ. DATES: Comments must be received on or before October 15, 2007. ADDRESSES: Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room @12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone
(202)366-9826. You must identify FAA Docket No. FAA-2007-28529; Airspace Docket No. 07-ANM-12, at the beginning of your comments. You may also submit comments through the Internet at *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation Administration, Western Service Area, System Support Group, 1601 Lind Avenue, SW., Renton, WA 98057; telephone
(425)917-6728. SUPPLEMENTARY INFORMATION: Comments Invited Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers (FAA Docket No. FAA-2007-28529 and Airspace Docket No. 07-ANM-12) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at *http://dms.dot.gov.* Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2007-28529 and Airspace Docket No. 07-ANM-12”. The postcard will be date/time stamped and returned to the commenter. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. Availability of NPRMs An electronic copy of this document may be downloaded through the Internet at *http://dms.dot.gov.* Recently published rulemaking documents can also be accessed through the FAA's web page at *http://www.faa.gov* or the **Federal Register** 's web page at *http://www.gpoaccess.gov/fr/index.html.* You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Area, System Support Group, 1601 Lind Avenue, SW., Renton, WA 98057. Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking,
(202)267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure. The Proposal The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E airspace at Tucson International Airport. Additional controlled airspace is necessary to encompass hold-in-lieu patterns at the LIPTE Initial Fix/Instrument Approach Fix (IF/IAF) at Tucson International Airport, Tucson, AZ and encompass intermediate segments from the ILEEN Distance Measuring Equipment
(DME)fix to COPEY DME fix. The FAA is proposing this action to enhance the safety and management of IFR operations at Tucson International Airport, Tucson, AZ. Class E airspace designations are published in paragraph 6005 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 Class E airspace designation listed in this document will be published subsequently in this Order. The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation:
(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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would 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 71 Airspace, Incorporation by reference, Navigation (air). The Proposed Amendment Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 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 14 CFR 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 the FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006 is amended as follows: Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface of the earth. AWP AZ E5 Tucson, AZ [Modified] Tucson International Airport, AZ (Lat. 32°06′58″ N., long. 110°56′28″ W.) Ryan Field, AZ (Lat. 32°08′32″ N., long. 111°10′28″ W.) That airspace extending upward from 700 feet above the surface within an 8.7-mile radius of Tucson International Airport and within that airspace bounded by a line beginning at lat. 32°11′01″ N., long.111°05′33″ W.; to lat. 32°21′28″ N., long.111°16′33″ W.; to lat. 32°35′55″ N., long. 110°57′47″ W.; to lat. 32°01′35″ N., long. 110°21′18″ W.; to lat. 31°44′6″ N., long. 110°42′30″ W.; to lat. 31°58′20″ N., long. 110°57′51″ W., to intercept the 8.7-mile radius southwest of the Tucson International Airport; thence clockwise via the 8.7-mile radius to the point of beginning; and that airspace within a 4.3-mile radius of Ryan Field and within 3.5 miles each side of the Ryan Field localizer course extending from the 4.3-mile radius to 7 miles west of the outer marker. That airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 32°33′00″ N., long. 111°45′02″ W.; to lat. 32°33′00″ N., long. 110°52′02″ W.; thence north via long.110°52′00″ W., to the south boundary of V-94, thence southeast via the south boundary of V-94; to long.110°00′02″ W., thence south to lat. 31°39′00″ N., long.110°00′02″ W.; to lat. 31°39′00″ N., long. 111°00′02″ W.; to lat. 32°00′00″ N., long. 111°45′02″ W., to the point of beginning. Issued in Seattle, Washington, on August 20, 2007. Clark Desing, Manager, System Support Group, Western Service Center. [FR Doc. E7-17068 Filed 8-28-07; 8:45 am] BILLING CODE 4910-13-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 49 and 51 [EPA-HQ-OAR-2006-0888, FRL-8461-9] RIN 2060-AH37 Prevention of Significant Deterioration New Source Review: Refinement of Increment Modeling Procedures AGENCY: Environmental Protection Agency (EPA). ACTION: Announcement of reopening of comment period. SUMMARY: The EPA is announcing a reopening of the public comment period on our proposed amendments for the Prevention of Significant Deterioration New Source Review: Refinements of Increment Modeling Procedures (June 6, 2007). The EPA is reopening the comment period that originally ended on August 6, 2007. The reopened comment period will close on September 28, 2007. The EPA is reopening the comment period because of the number of requests we received in a timely manner. DATES: *Comments.* Comments on the proposed rule published June 6, 2007 (72 FR 31371) must be received on or before September 28, 2007. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2006-0888, by one of the following methods: • *www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: a-and-r-docket@epamail.epa.gov.* • *Fax:* 202-566-9744. • *Mail:* Attention Docket ID No. EPA-HQ-OAR-2006-0888, U.S. Environmental Protection Agency, EPA West (Air Docket), 1200 Pennsylvania Avenue, Northwest, Mailcode: 6102T, Washington, DC 20460. Please include a total of 2 copies. In addition, please mail a copy of your comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC 20503. • *Hand Delivery:* U.S. Environmental Protection Agency, EPA West (Air Docket), 1301 Constitution Avenue, Northwest, Room 3334, Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2006-0888. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-HQ-OAR-2006-0888. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional instructions on submitting comments, go to the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the U.S. Environmental Protection Agency, Air Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Air Docket is
(202)566-1742. FOR FURTHER INFORMATION CONTACT: For technical information, contact Jessica Montanez, Air Quality Policy Division, U.S. EPA, Office of Air Quality Planning and Standards (C504-03), Research Triangle Park, North Carolina 27711, telephone number
(919)541-3407, facsimile number
(919)541-5509, electronic mail e-mail address: *montanez.jessica@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI.* Do not submit this information to EPA through *www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Send or deliver information identified as CBI only to the following address: Roberto Morales, OAQPS Document Control Officer (C404-02), U.S. EPA, Research Triangle Park, NC 27711, Attention Docket ID No. EPA-HQ-OAR-2006-0888. 2. *Tips for Preparing Your Comments.* When submitting comments, remember to: • Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). • Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. • Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. B. Where Can I Get a Copy of This Document and Other Related Information? In addition to being available in the docket, an electronic copy of this proposal will also be available on the World Wide Web (WWW). Following signature by the EPA Administrator, a copy of this notice will be posted in the regulations and standards section of our NSR home page located at *http://www.epa.gov/nsr* and on the tribal air home page at *http://www.epa.gov/oar/tribal.* Dated: August 21, 2007. Lydia Wegman, Acting Director, Office of Air Quality Planning and Standards. [FR Doc. E7-17104 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R04-OAR-2007-0549-200727; FRL-8461-7] Approval and Promulgation of Implementation Plans and Designations of Areas for Air Quality Planning Purposes; Georgia: Redesignation of the Murray County 8-Hour Ozone Nonattainment Area to Attainment for Ozone AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: On June 15, 2007, the State of Georgia, through the Georgia Environmental Protection Division (EPD), submitted a request to redesignate the Murray County 8-hour ozone nonattainment area (Murray County Area) to attainment for the 8-hour ozone National Ambient Air Quality Standard (NAAQS); and to approve a State Implementation Plan
(SIP)revision containing a maintenance plan for the Murray County Area. The Murray County 8-hour nonattainment ozone area is a partial county area, comprised of the portion of Murray County that makes up the Chattahoochee National Forest. In this action, EPA is proposing to approve Georgia's 8-hour ozone redesignation request for the Murray County Area. Additionally, EPA is proposing to approve the 8-hour ozone maintenance plan for the Murray County Area, including the regional motor vehicle emissions budgets (MVEBs) for nitrogen oxides (NO <sup>X</sup> ) and volatile organic compounds (VOCs). This proposed approval of Georgia's redesignation request is based on EPA's determination that Georgia has demonstrated that the Murray County Area has met the criteria for redesignation to attainment specified in the Clean Air Act (CAA), including the determination that the Murray County 8-hour ozone nonattainment area has attained the 8-hour ozone standard. In this action, EPA is also describing the status of its transportation conformity adequacy determination for the new regional MVEBs for 2018 that are contained in the 8-hour ozone maintenance plan for the Murray County Area. DATES: Comments must be received on or before September 28, 2007. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-OAR-2007-0549, by one of the following methods:
(a)*www.regulations.gov:* Follow the on-line instructions for submitting comments.
(b)*E-mail: Harder.Stacy@epa.gov.*
(c)*Fax:*
(404)562-9019.
(d)*Mail:* EPA-R04-OAR-2007-0549, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960.
(e)*Hand Delivery or Courier:* Stacy Harder, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding Federal holidays. *Instructions:* Direct your comments to Docket ID No. EPA-R04-OAR-2007-0549. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit through *www.regulations.gov* or e-mail, information that you consider to be CBI or otherwise protected. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov,* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the electronic docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, i.e., 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 electronically in *www.regulations.gov* or in hard copy at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal holidays. FOR FURTHER INFORMATION CONTACT: Ms. Stacy Harder of the Regulatory Development Section at the Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Ms. Harder's telephone number is
(404)562-9042. She can also be reached via electronic mail at *harder.stacy@epa.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. What Proposed Actions is EPA Taking? II. What Is the Background for EPA's Proposed Actions? III. What Are the Criteria for Redesignation? IV. Why Is EPA Proposing These Actions? V. What Is the Effect of EPA's Proposed Actions? VI. What Is EPA's Analysis of the Request? VII. What Are the Proposed Regional MVEBs for the Murray County Area? VIII. What Is the Status of EPA's Adequacy Determination for MVEBs for the Year 2018 for the Murray County Area? IX. Proposed Action on the Redesignation Request and Maintenance Plan SIP Revision Including Proposed Approval of the 2018 MVEBs X. Statutory and Executive Order Reviews I. What Proposed Actions Is EPA Taking? EPA is proposing to take two related actions, which are summarized below and described in greater detail throughout this notice of proposed rulemaking:
(1)to redesignate the Murray County Area to attainment for the 8-hour ozone NAAQS; and
(2)to approve Georgia's 8-hour ozone maintenance plan into the Georgia SIP, including the associated MVEBs. EPA is also notifying the public of the status of EPA's adequacy determination for the Murray County Area MVEBs. First, EPA is proposing to determine that the Murray County Area has attained the 8-hour ozone standard, and that the Murray County Area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA. EPA is now proposing to approve a request to change the legal designation of the Murray County Area from nonattainment to attainment for the 8-hour ozone NAAQS. Second, EPA is proposing to approve Georgia's 8-hour ozone maintenance plan for the Murray County Area (such approval being one of the CAA criteria for redesignation to attainment status). The maintenance plan is designed to help keep the Murray County Area in attainment with the 8-hour ozone NAAQS through 2018. Consistent with the CAA, the maintenance plan that EPA is proposing to approve today also includes 2018 regional MVEBs for NO <sup>X</sup> and VOCs. Therefore, EPA is proposing to approve into the Georgia SIP the 2018 regional MVEBs that are included as part of Georgia's maintenance plan. These regional MVEBs apply to the Murray County Area. In this proposed rulemaking, EPA is notifying the public of the status of EPA's adequacy process for the newly established 2018 MVEBs for the Murray County Area. The adequacy comment period for the Murray County Area's 2018 MVEBs began on June 21, 2007, with EPA's posting of the availability of this submittal on EPA's Adequacy Web Site ( *http://www.epa.gov/otaq/stateresources/transconf/currsips.htm* ). The adequacy comment period for these MVEBs closed on July 23, 2007. No adverse comments were received on this submittal during the adequacy public comment period. Please see section VIII of this proposed rulemaking for further explanation of this process, and for more details on the MVEBs. Today's notice of proposed rulemaking is in response to Georgia's June 15, 2007, SIP submittal. The June 15, 2007, submittal requests redesignation of the Murray County Area, and included a SIP revision addressing the specific issues summarized above and the necessary elements for redesignation described in section 107(d)(3)(E) of the CAA. II. What Is the Background for EPA's Proposed Actions? Ground-level ozone is not emitted directly by sources. Rather, emissions of NO <sup>X</sup> and VOCs react in the presence of sunlight to form ground-level ozone. NO <sup>X</sup> and VOCs are referred to as precursors of ozone. The CAA establishes a process for air quality management through the NAAQS. On July 18, 1997, EPA promulgated a revised 8-hour ozone standard of 0.08 parts per million (ppm). This new standard is more stringent than the previous 1-hour ozone standard. Under EPA regulations at 40 CFR part 50, the 8-hour ozone standard is attained when the 3-year average of the annual fourth highest daily maximum 8-hour average ambient air quality ozone concentrations is less than or equal to 0.08 ppm (i.e., 0.084 ppm when rounding is considered). (See, 69 FR 23857 (April 30, 2004) for further information.) Ambient air quality monitoring data for the 3-year period must meet a data completeness requirement. The ambient air quality monitoring data completeness requirement is met when the average percent of days with valid ambient monitoring data is greater than 90 percent, and no single year has less than 75 percent data completeness as determined in Appendix I of part 50. Specifically, section 2.3 of 40 CFR part 50, Appendix I, “Comparisons with the Primary and Secondary Ozone Standards” states: The primary and secondary ozone ambient air quality standards are met at an ambient air quality monitoring site when the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentration is less than or equal to 0.08 ppm. The number of significant figures in the level of the standard dictates the rounding convention for comparing the computed 3-year average annual fourth-highest daily maximum 8-hour average ozone concentration with the level of the standard. The third decimal place of the computed value is rounded, with values equal to or greater than 5 rounding up. Thus, a computed 3-year average ozone concentration of 0.085 ppm is the smallest value that is greater than 0.08 ppm. The CAA required EPA to designate as nonattainment any area that was violating the 8-hour ozone NAAQS based on the three most recent years of ambient air quality data. The Murray County 8-hour ozone nonattainment area was designated using 2001-2003 ambient air quality data. The **Federal Register** document making these designations was signed on April 15, 2004, and published on April 30, 2004 (69 FR 23857). The CAA contains two sets of provisions—subpart 1 and subpart 2—that address planning and control requirements for ozone nonattainment areas. (Both are found in title I, part D.) Subpart 1 (which EPA refers to as “basic” nonattainment) contains general, less prescriptive, requirements for nonattainment areas for any pollutant—including ozone—governed by a NAAQS. Subpart 2 (which EPA refers to as “classified” nonattainment) provides more specific requirements for certain ozone nonattainment areas. Some 8-hour ozone nonattainment areas are subject only to the provisions of subpart 1. Other 8-hour ozone nonattainment areas are also subject to the provisions of subpart 2. Under EPA's Phase 1 8-hour ozone implementation rule (69 FR 23857) (Phase 1 Rule), signed on April 15, 2004, and published April 30, 2004, an area was classified under subpart 2 based on its 8-hour ozone design value (i.e., the 3-year average of the annual fourth-highest daily maximum 8-hour average ozone concentrations), if it had a 1-hour design value at or above 0.121 ppm (the lowest 1-hour design value in Table 1 of subpart 2). All other areas are covered under subpart 1, based upon their 8-hour ambient air quality design values. On April 30, 2004, EPA designated the Murray County Area as a “basic” 8-hour ozone nonattainment area (see, 69 FR 23857, April 30, 2004). Thus, on June 15, 2007, when Georgia submitted its final redesignation request, the Murray County Area was classified under subpart 1 of the CAA, and was obligated to meet only the subpart 1 requirements. Various aspects of EPA's Phase 1 8-hour ozone implementation rule were challenged in court. On December 22, 2006, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit Court) vacated EPA's Phase 1 Implementation Rule for the 8-hour Ozone Standard (69 FR 23951, April 30, 2004). *South Coast Air Quality Management Dist. (SCAQMD)* v. *EPA,* 472 F.3d 882 (D.C.Cir. 2006). On June 8, 2007, in response to several petitions for rehearing, the D.C. Circuit Court clarified that the Phase 1 Rule was vacated only with regard to those parts of the Rule that had been successfully challenged. Therefore, the Phase 1 Rule provisions related to classifications for areas currently classified under subpart 2 of title I, part D of the CAA as 8-hour nonattainment areas, the 8-hour attainment dates and the timing for emissions reductions needed for attainment of the 8-hour ozone NAAQS remain effective. The June 8th decision left intact the Court's rejection of EPA's reasons for implementing the 8-hour standard in certain nonattainment areas under subpart 1 in lieu of subpart 2. By limiting the vacatur, the Court let stand EPA's revocation of the 1-hour standard and those anti-backsliding provisions of the Phase 1 Rule that had not been successfully challenged. The June 8th decision reaffirmed the December 22, 2006, decision that EPA had improperly failed to retain measures required for 1-hour nonattainment areas under the anti-backsliding provisions of the regulations:
(1)Nonattainment area New Source Review
(NSR)requirements based on an area's 1-hour nonattainment classification;
(2)Section 185 penalty fees for 1-hour severe or extreme nonattainment areas; and
(3)measures to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the CAA, on the contingency of an area not making reasonable further progress toward attainment of the 1-hour NAAQS, or for failure to attain that NAAQS. The June 8th decision clarified that the Court's reference to conformity requirements for anti-backsliding purposes was limited to requiring the continued use of 1-hour MVEBs until 8-hour budgets were available for 8-hour conformity determinations, which is already required under EPA's conformity regulations. The Court thus clarified that 1-hour conformity determinations are not required for anti-backsliding purposes. This section sets forth EPA's views on the potential effect of the Court's rulings on this proposed redesignation action. For the reasons set forth below, EPA does not believe that the Court's rulings alter any requirements relevant to this redesignation action so as to preclude redesignation, and do not prevent EPA from proposing or ultimately finalizing this redesignation. EPA believes that the Court's December 22, 2006, and June 8, 2007, decisions impose no impediment to moving forward with redesignation of the Murray County Area to attainment. Even in light of the Court's decisions, redesignation is appropriate under the relevant redesignation provisions of the CAA and longstanding policies regarding redesignation requests. With respect to the 8-hour standard, the Court's ruling rejected EPA's reasons for classifying areas under subpart 1 for the 8-hour standard, and remanded that matter to the Agency. Consequently, it is possible that this Area could, during a remand to EPA, be reclassified under subpart 2. Although any future decision by EPA to classify this area under subpart 2 might trigger additional future requirements for the area, EPA believes that this does not mean that redesignation of the area cannot now go forward. This belief is based upon
(1)EPA's longstanding policy of evaluating redesignation requests in accordance with the requirements due at the time the request is submitted; and
(2)consideration of the inequity of applying retroactively any requirements that might in the future be applied. First, at the time the redesignation request was submitted, the Murray County Area was classified under subpart 1 and was obligated to meet only subpart 1 requirements. Under EPA's longstanding interpretation of section 107(d)(3)(E) of the CAA, to qualify for redesignation, states requesting redesignation to attainment must meet only the relevant SIP requirements that came due prior to the submittal of a complete redesignation request. See, September 4, 1992, Calcagni Memorandum (“Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division). See also, Michael Shapiro Memorandum, September 17, 1993, and 60 FR 12459, 12465-66 (March 7, 1995) (Redesignation of Detroit-Ann Arbor, Michigan). See, *Sierra Club* v. *EPA,* 375 F.3d 537 (7th Cir. 2004), which upheld this interpretation. See, e.g. also, 68 FR 25418, 25424, 25427 (May 12, 2003) (redesignation of St. Louis, Missouri). Moreover, it would be inequitable to retroactively apply any new SIP requirements that were not applicable at the time the request was submitted. The D.C. Circuit Court has recognized the inequity in such retroactive rulemaking ( *Sierra Club* v. *Whitman,* 285 F.3d 63 (D.C. Cir. 2002)), in which the Court upheld a district court's ruling refusing to make retroactive an EPA determination of nonattainment that was past the statutory due date. Such a determination would have resulted in the imposition of additional requirements on the area. The Court stated, “Although EPA failed to make the nonattainment determination within the statutory time frame, Sierra Club's proposed solution only makes the situation worse. Retroactive relief would likely impose large costs on the States, which would face fines and suits for not implementing air pollution prevention plans in 1997, even though they were not on notice at the time.” *Id.* at 68. Similarly here, it would be unfair to penalize the area by applying to it for purposes of redesignation, additional SIP requirements under subpart 2 that were not in effect at the time it submitted its redesignation request. As noted earlier, in 2004, the ambient ozone data for the Murray County Area indicated no further violations of the 8-hour ozone NAAQS, using data from the 3-year period of 2002-2004 to demonstrate attainment. As a result, on June 15, 2007, Georgia requested redesignation of the Murray County Area to attainment for the 8-hour ozone NAAQS. The redesignation request included three years of complete, quality-assured ambient air quality data for the ozone seasons (March 1st until October 31st) of 2002-2004, indicating that the 8-hour ozone NAAQS has been achieved for the Murray County Area. Under the CAA, nonattainment areas may be redesignated to attainment if sufficient, complete, quality-assured data is available for the Administrator to determine that the area has attained the standard and the area meets the other CAA redesignation requirements in section 107(d)(3)(E). III. What Are the Criteria for Redesignation? The CAA provides the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) of the CAA allows for redesignation providing that:
(1)The Administrator determines that the area has attained the applicable NAAQS;
(2)the Administrator has fully approved the applicable implementation plan for the area under section 110(k);
(3)the Administrator determines that the improvement in air quality is due to permanent and enforceable reductions in emissions resulting from implementation of the applicable SIP and applicable Federal air pollutant control regulations and other permanent and enforceable reductions;
(4)the Administrator has fully approved a maintenance plan for the area as meeting the requirements of section 175A; and,
(5)the state containing such area has met all requirements applicable to the area under section 110 and part D of the CAA. EPA provided guidance on redesignation in the General Preamble for the Implementation of Title I of the CAA Amendments of 1990, on April 16, 1992 (57 FR 13498), and supplemented this guidance on April 28, 1992 (57 FR 18070). EPA has provided further guidance on processing redesignation requests in the following documents: 1. “Ozone and Carbon Monoxide Design Value Calculations,” Memorandum from Bill Laxton, Director, Technical Support Division, June 18, 1990; 2. “Maintenance Plans for Redesignation of Ozone and Carbon Monoxide Nonattainment Areas,” Memorandum from G.T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, April 30, 1992; 3. “Contingency Measures for Ozone and Carbon Monoxide
(CO)Redesignations,” Memorandum from G. T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, June 1, 1992; 4. “Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992 (hereafter referred to as the “Calcagni Memorandum”); 5. “State Implementation Plan
(SIP)Actions Submitted in Response to Clean Air Act
(ACT)Deadlines,” Memorandum from John Calcagni, Director, Air Quality Management Division, October 28, 1992; 6. “Technical Support Documents (TSD's) for Redesignation of Ozone and Carbon Monoxide
(CO)Nonattainment Areas,” Memorandum from G. T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch, August 17, 1993; 7. “State Implementation Plan
(SIP)Requirements for Areas Submitting Requests for Redesignation to Attainment of the Ozone and Carbon Monoxide
(CO)National Ambient Air Quality Standards (NAAQS) On or After November 15, 1992,” Memorandum from Michael H. Shapiro, Acting Assistant Administrator for Air and Radiation, September 17, 1993; 8. “Use of Actual Emissions in Maintenance Demonstrations for Ozone and CO Nonattainment Areas,” Memorandum from D. Kent Berry, Acting Director, Air Quality Management Division, November 30, 1993; 9. “Part D New Source Review (Part D NSR) Requirements for Areas Requesting Redesignation to Attainment,” Memorandum from Mary D. Nichols, Assistant Administrator for Air and Radiation, October 14, 1994; and 10. “Reasonable Further Progress, Attainment Demonstration, and Related Requirements for Ozone Nonattainment Areas Meeting the Ozone National Ambient Air Quality Standard,” Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, May 10, 1995. IV. Why Is EPA Proposing These Actions? On June 15, 2007, Georgia requested redesignation of the Murray County 8-hour ozone nonattainment area to attainment for the 8-hour ozone standard. EPA's evaluation indicates that Georgia has demonstrated that the Murray County Area has attained the standard and has met the requirements for redesignation set forth in section 107(d)(3)(E) of the CAA. EPA is also announcing the status of its adequacy determination for the 2018 regional MVEBs, which is relevant to the requested redesignation. V. What Is the Effect of EPA's Proposed Actions? EPA's proposed actions establish the basis upon which EPA may take final action on the issues being proposed for approval today. Approval of Georgia's redesignation request would change the legal designation of the Murray County Area for the 8-hour ozone NAAQS found at 40 CFR part 81. Approval of Georgia's request would also incorporate into the Georgia SIP, a plan for the Murray County Area for maintaining the 8-hour ozone NAAQS in the area through 2018. This maintenance plan includes contingency measures to remedy future violations of the 8-hour ozone NAAQS. The maintenance plan also establishes regional MVEBs for the year 2018 of 0.0117 tons per day
(tpd)for VOCs and 0.0129 tpd for NO <sup>X</sup> , for the Murray County Area. Approval of Georgia's maintenance plan would also result in approval of the regional MVEBs. Additionally, EPA is notifying the public of the status of its adequacy determination for the 2018 regional MVEBs, pursuant to 40 CFR 93.118(f)(1). VI. What Is EPA's Analysis of the Request? EPA is proposing to make the determination that the Murray County Area has attained the 8-hour ozone standard, and that all other redesignation criteria have been met for the Murray County Area. The basis for EPA's determination for the area is discussed in greater detail below. Criteria (1)—The Murray County Area Has Attained the 8-Hour Ozone NAAQS EPA is proposing to determine that the Murray County Area has attained the 8-hour ozone NAAQS. For ozone, an area may be considered to be attaining the 8-hour ozone NAAQS if there are no violations, as determined in accordance with 40 CFR 50.10 and Appendix I of part 50, based on three complete, consecutive calendar years of quality-assured air quality monitoring data. To attain this standard, the 3-year average of the fourth-highest daily maximum 8-hour average ozone concentrations measured at each monitor within an area over each year must not exceed 0.08 ppm. Based on the rounding convention described in 40 CFR part 50, Appendix I, the standard is attained if the design value is 0.084 ppm or below. The data must be collected and quality-assured in accordance with 40 CFR part 58, and recorded in the EPA Air Quality System (AQS). The monitors generally should have remained at the same location for the duration of the monitoring period required for demonstrating attainment. EPA reviewed ozone monitoring data from the ambient ozone monitoring station in the Murray County Area for the ozone season from 2002—2004. This data has been quality assured and is recorded in AQS. The fourth high average for 2002, 2003, and 2004, and the 3-year average of these values (i.e., design values), are summarized in the following table: Table 1.—Annual 4th Max High and Design Value Concentration for 8-Hour Ozone for the Murray County Area (In Parts per Million) Site name 4th highest value
(ppm)2000 2001 2002 2003 2004 2005 2006 3-year average 2002-2004 Fort Mountain 0.091 0.080 0.092 0.085 0.074 0.080 0.074 0.084 As discussed above, the design value for an area is the highest design value recorded at any monitor in the area. Therefore, the design value for the Murray County Area is 0.084 ppm, which meets the standard as described above. As discussed in more detail below, Georgia has committed to continue monitoring in this area in accordance with 40 CFR part 58. The data submitted by Georgia provides an adequate demonstration that the Murray County Area has attained the 8-hour ozone NAAQS. Additional data for 2005 and 2006 show continued attainment; however, the analysis for EPD's submittal was initiated prior to the certification of 2005 and 2006 data, which provides an even greater margin of compliance. Criteria (2)—Georgia Has a Fully Approved SIP Under Section 110(k) For the Murray County Area and Criteria (5)—Has Met All Applicable Requirements Under Section 110 and Part D of the CAA Below is a summary of how these two criteria were met. EPA has determined that Georgia has met all applicable SIP requirements for the Murray County Area under section 110 of the CAA (general SIP requirements). EPA has also determined that the Georgia SIP satisfies the criterion that it meet applicable SIP requirements under part D of title I of the CAA (requirements specific to subpart 1 basic 8-hour ozone nonattainment areas) in accordance with section 107(d)(3)(E)(v). In addition, EPA has determined that the SIP is fully approved with respect to all applicable requirements in accordance with section 107(d)(3)(E)(ii). In making these determinations, EPA ascertained which requirements are applicable to the area and that if applicable, they are fully approved under section 110(k). SIPs must be fully approved only with respect to applicable requirements. a. The Murray County Area Has Met All Applicable Requirements Under Section 110 and Part D of the CAA The September 4, 1992, Calcagni Memorandum (see “Procedures for Processing Requests to Redesignate Areas to Attainment,” Memorandum from John Calcagni, Director, Air Quality Management Division, September 4, 1992) describes EPA's interpretation of section 107(d)(3)(E). Under this interpretation, to qualify for redesignation, states requesting redesignation to attainment must meet only the relevant CAA requirements that come due prior to the submittal of a complete redesignation request. See also, Michael Shapiro Memorandum, (“SIP Requirements for Areas Submitting Requests for Redesignation to Attainment of the Ozone and Carbon Monoxide NAAQS On or After November 15, 1992,” September 17, 1993), and 60 FR 12459, 12465-66 (March 7, 1995) (redesignation of Detroit-Ann Arbor, Michigan). Applicable requirements of the CAA that come due subsequent to the area's submittal of a complete redesignation request remain applicable until a redesignation is approved, but are not required as a prerequisite to redesignation. See, section 175A(c) of the CAA; *Sierra Club* , 375 F.3d 537; see also, 68 FR 25424, 25427 (May 12, 2003) (redesignation of St. Louis, Missouri). *General SIP requirements.* Section 110(a)(2) of title I of the CAA delineates the general requirements for a SIP, which include enforceable emissions limitations and other control measures, means, or techniques, provisions for the establishment and operation of appropriate devices necessary to collect data on ambient air quality, and programs to enforce the limitations. General SIP elements and requirements are delineated in section 110(a)(2) of title I, part A of the CAA. These requirements include, but are not limited to, the following: submittal of a SIP that has been adopted by the state after reasonable public notice and hearing; provisions for establishment and operation of appropriate procedures needed to monitor ambient air quality; implementation of a source permit program; provisions for the implementation of part C requirements (Prevention of Significant Deterioration (PSD)) and provisions for the implementation of part D requirements (NSR permit programs); provisions for air pollution modeling; and provisions for public and local agency participation in planning and emission control rule development. Section 110(a)(2)(D) requires that SIPs contain certain measures to prevent sources in a state from significantly contributing to air quality problems in another state. To implement this provision, EPA has required certain states to establish programs to address the transport of air pollutants (NO <sup>X</sup> SIP Call, Clean Air Interstate Rule (CAIR)). EPA has also found, generally, that states have not submitted SIPs under section 110(a)(1) to meet the interstate transport requirements of section 110(a)(2)(D)(i). However, the section 110(a)(2)(D) requirements for a state are not linked with a particular nonattainment area's designation and classification in that state. EPA believes that the requirements linked with a particular nonattainment area's designation and classifications are the relevant measures to evaluate in reviewing a redesignation request. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area in the state. Thus, we do not believe that the CAA's interstate transport requirements should be construed to be applicable requirements for purposes of redesignation. In addition, EPA believes that the other section 110 elements not connected with nonattainment plan submissions and not linked with an area's attainment status are not applicable requirements for purposes of redesignation. The area will still be subject to these requirements after the area is redesignated. The section 110 and part D requirements, which are linked with a particular area's designation and classification, are the relevant measures to evaluate in reviewing a redesignation request. This approach is consistent with EPA's existing policy on applicability (i.e., for redesignations) of conformity and oxygenated fuels requirements, as well as with section 184 ozone transport requirements. See, Reading, Pennsylvania, proposed and final rulemakings (61 FR 53174-53176, October 10, 1996), (62 FR 24826, May 7, 1997); Cleveland-Akron-Loraine, Ohio, final rulemaking (61 FR 20458, May 7, 1996); and Tampa, Florida, final rulemaking at (60 FR 62748, December 7, 1995). See also, the discussion on this issue in the Cincinnati, Ohio redesignation (65 FR 37890, June 19, 2000), and in the Pittsburgh, Pennsylvania redesignation (66 FR 50399, October 19, 2001). EPA believes that section 110 elements not linked to the area's nonattainment status are not applicable for purposes of redesignation. Any section 110 requirements that are linked to the part D requirements for 8-hour ozone nonattainment areas are not yet due, since, as explained below, no part D requirements for 8-hour standard became due prior to submission of the redesignation request. Therefore, as discussed above, for purposes of redesignation, they are not considered applicable requirements. Nonetheless, EPA notes it has previously approved provisions in the Georgia SIP addressing section 110 elements under the 1-hour ozone NAAQS (See, 70 FR 34660, June 15, 2005). EPA believes that the section 110 SIP approved for the 1-hour ozone NAAQS is also sufficient to meet the requirements under the 8-hour ozone NAAQS (as well as satisfying the issues raised by the D.C. Circuit Court in the *SCAQMD* case). *Part D requirements.* EPA has also determined that the Georgia SIP meets applicable SIP requirements under part D of the CAA since no requirements became due prior to the submission of the Area's redesignation request. Sections 172-176 of the CAA, found in subpart 1 of part D, set forth the basic nonattainment requirements applicable to all nonattainment areas. Section 182 of the CAA, found in subpart 2 of part D, establishes additional specific requirements depending on the area's nonattainment classification. Subpart 2 is not applicable to the Murray County Area. *Part D, subpart 1 applicable SIP requirements.* For purposes of evaluating this redesignation request, the applicable part D, subpart 1 SIP requirements for all nonattainment areas are contained in sections 172(c)(1)-(9). A thorough discussion of the requirements contained in section 172 can be found in the General Preamble for Implementation of title I (57 FR 13498). No requirements applicable for purposes of redesignation under part D became due prior to the submission of the redesignation request, and therefore none are applicable to the Area for purposes of redesignation. For example, the requirements for an attainment demonstration that meets the requirements of section 172(c)(1) are not yet applicable, nor are the requirements for Reasonably Achievable Control Technology
(RACT)and Reasonably Available Control Measures
(RACM)(section 172(c)(1)), reasonable further progress
(RFP)(section 172(c)(2)), and contingency measures (section 172(c)(9)). In addition to the fact that no part D requirements applicable for purposes of redesignation became due prior to submission of the redesignation request and therefore are not applicable, EPA believes it is reasonable to interpret the conformity and NSR requirements as not requiring approval prior to redesignation. *Section 176 Conformity Requirements.* Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that Federally supported or funded projects conform to the air quality planning goals in the applicable SIP. The requirement to determine conformity applies to transportation plans, programs and projects developed, funded or approved under title 23 of the United States Code (U.S.C.) and the Federal Transit Act (transportation conformity) as well as to all other Federally supported or funded projects (general conformity). State conformity revisions must be consistent with Federal conformity regulations relating to consultation, enforcement and enforceability that the CAA required the EPA to promulgate. EPA believes it is reasonable to interpret the conformity SIP requirements as not applying for purposes of evaluating the redesignation request under section 107(d), because state conformity rules are still required after redesignation and Federal conformity rules apply where state rules have not been approved. See, *Wall* v. *EPA* , 265 F.3d 426 (6th Cir. 2001), (upholding this interpretation). See also, 60 FR 62748 (December 7, 1995, Tampa, Florida). *NSR Requirements.* EPA has also determined that areas being redesignated need not comply with the requirement that a NSR program be approved prior to redesignation, provided that the area demonstrates maintenance of the standard without a part D NSR program in effect since PSD requirements will apply after redesignation. The rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled “Part D New Source Review (Part D NSR) Requirements for Areas Requesting Redesignation to Attainment.” Georgia has demonstrated that the Murray County Area will be able to maintain the standard without a part D NSR program in effect, and therefore, Georgia need not have a fully approved part D NSR program prior to approval of the redesignation request. Georgia's PSD program will become effective in the Murray County Area upon redesignation to attainment. See, rulemakings for Detroit, Michigan (60 FR 12467-12468, March 7, 1995); Cleveland-Akron-Lorraine, Ohio (61 FR 20458, 20469-70, May 7, 1996); Louisville, Kentucky (66 FR 53665, October 23, 2001); Grand Rapids, Michigan (61 FR 31834-31837, June 21, 1996). Thus, the Murray County Area has satisfied all applicable requirements for purposes of redesignation under section 110 and part D of the CAA. b. The Area Has a Fully Approved Applicable SIP Under Section 110(k) of the CAA EPA has fully approved the applicable Georgia SIP for the portion of Murray County affected by today's proposed redesignation, under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. EPA may rely on prior SIP approvals in approving a redesignation request, see Calcagni Memorandum at p. 3; *Southwestern Pennsylvania Growth Alliance* v. *Browner* , 144 F.3d 984, 989-90 (6th Cir. 1998); *Wall* , 265 F.3d 426, plus any additional measures it may approve in conjunction with a redesignation action. See, 68 FR 25426 (May 12, 2003) and citations therein. Following passage of the CAA of 1970, Georgia has adopted and submitted, and EPA has fully approved at various times, provisions addressing the various 1-hour ozone standard SIP elements applicable in Murray County, Georgia (See, 70 FR 34660, June 15, 2005). As indicated above, EPA believes that the section 110 elements not connected with nonattainment plan submissions and not linked to the area's nonattainment status are not applicable requirements for purposes of redesignation. EPA also believes that since the part D requirements applicable for purposes of redesignation did not become due prior to submission of the redesignation request, they also are therefore not applicable requirements for purposes of redesignation. Criteria (3)—The Air Quality Improvement in the Murray County Area is Due to Permanent and Enforceable Reductions in Emissions Resulting From Implementation of the SIP and Applicable Federal Air Pollution Control Regulations and Other Permanent and Enforceable Reductions EPA believes that Georgia has demonstrated that the observed air quality improvement in the Murray County Area is due to permanent and enforceable reductions in emissions resulting from implementation of the SIP, Federal measures, and other state-adopted measures. Additionally, new emissions control programs for fuels and motor vehicles will help ensure a continued decrease in emissions throughout the region. Table 2 Murray county area emission reductions programs Onboard Refueling Vapor Recovery for Light-Duty Vehicles. Architectural and Industrial Maintenance Coatings. Automobile Refinishing. The National Emission Standards for Hazardous Air Pollutants (NESHAP); the majority of which are also VOCs. Phase II Acid Rain Program for NO <sup>X</sup> . Tier 2 Motor Vehicle Emissions Standards and Gasoline Sulfur Control Requirements. Regional NO <sup>X</sup> SIP Call. Although the NO <sup>X</sup> SIP Call is stayed in Georgia, this regional program implemented in neighboring states, has resulted in measurable emissions reductions that have lowed pollution transported into Murray County. Criteria (4)—The Area Has a Fully Approved Maintenance Plan Pursuant to Section 175A of the CAA In its request to redesignate the Murray County Area to attainment, EPD submitted a SIP revision to provide for the maintenance of the 8-hour ozone NAAQS for at least 10 years after the effective date of redesignation to attainment. a. What is required in a maintenance plan? Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the plan must demonstrate continued attainment of the applicable NAAQS for at least 10 years after the Administrator approves a redesignation to attainment. Eight years after the redesignation, the State of Georgia must submit a revised maintenance plan which demonstrates that attainment will continue to be maintained for the 10 years following the initial 10-year period. To address the possibility of future NAAQS violations, the maintenance plan must contain such contingency measures, with a schedule for implementation, as EPA deems necessary to assure prompt correction of any future 8-hour ozone violations. Section 175A of the CAA sets forth the elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. The Calcagni Memorandum provides additional guidance on the content of a maintenance plan. The Calcagni Memorandum explains that an ozone maintenance plan should address five requirements: the attainment emissions inventory, maintenance demonstration, monitoring, verification of continued attainment, and a contingency plan. As is discussed more fully below, Georgia's maintenance plan includes all the necessary components and is approvable as part of the redesignation request. b. Attainment Emissions Inventory Georgia selected 2004 as “the attainment year” for the Murray County Area for the purposes of demonstrating attainment of the 8-hour ozone NAAQS. This attainment inventory identifies the level of emissions in the area, which is sufficient to attain the 8-hour ozone standard. Georgia began development of this attainment inventory by first developing a baseline emissions inventory for the Murray County Area. The year 2002 was chosen as the base year for developing a comprehensive ozone precursor emissions inventory for which projected emissions could be developed for 2002, 2009, and 2018. Non-road mobile emissions estimates were based on EPA's NONROAD2005 model. On-road mobile source emissions were calculated using EPA's MOBILE6.2 emission factors model. The 2004 VOCs and NO <sup>X</sup> emissions, as well as the emissions for other years, for the Murray County Area were developed consistent with EPA guidance, and are summarized in Tables 3 and 4 in the following subsection. c. Maintenance Demonstration The June 15, 2007, final submittal includes a maintenance plan for the Murray County Area. This demonstration:
(i)Shows compliance and maintenance of the 8-hour ozone standard by providing information to support the demonstration that current and future emissions of VOCs and NO <sup>X</sup> remain at or below attainment year 2004 emissions levels. The year 2004 was chosen as the attainment year because it is one of the most recent three years (i.e., 2002, 2003, and 2004) for which the Murray County Area has clean air quality data for the 8-hour ozone standard.
(ii)Uses 2004 as the attainment year and includes future emission inventory projections for 2002, 2009, and 2018.
(iii)Identifies an “out year” at least 10 years after the time necessary for EPA to review and approve the maintenance plan. Per 40 CFR part 93, MVEBs were established for the last year
(2018)of the maintenance plan. See, section VII below.
(iv)Provides the following actual and projected emissions inventories for the Murray County Area. See, Tables 3 and 4. Table 3.—Murray County Area Emissions of VOCs [Tons per summer day] Source category 2002 2009 2018 Area* 0.0209 0.0204 0.0240 Mobile** 0.0171 0.0126 0.0075 Nonroad 0.0050 0.0033 0.0031 Total 0.0430 0.0363 0.0346 Safety Margin*** N/A 0.0067 0.0084 *Scaled according to the population of the partial county area. ** Calculated using MOBILE6.2. *** After assigning 0.0042 TPD of the 2018 VOCs safety margin to the MVEB, the revised 2018 safety margin will be 0.0042 TPD. Table 4.—Murray County Area NO <sup>X</sup> Emissions [Tons per summer day] Source category 2002 2009 2018 Area* 0.0070 0.0072 0.0076 Mobile** 0.0156 0.0119 0.0073 Nonroad 0.0054 0.0040 0.0020 Total 0.0280 0.0231 0.0169 Safety Margin*** N/A 0.0049 0.0111 *Scaled according to the population of the partial county area. ** Calculated using MOBILE6.2. *** After assigning 0.0056 TPD of the 2018 NO <sup>X</sup> safety margin to the MVEB, the revised 2018 safety margin will be 0.0055 TPD. A safety margin is the difference between the attainment level of emissions (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. The attainment level of emissions is the level of emissions during one of the years in which the area met the NAAQS. Georgia has decided to allocate a portion of the available safety margin to the regional 2018 MVEBs for NO <sup>X</sup> and VOCs for the Murray County Area, and has calculated the safety margin in its submittal. See, Tables 3 and 4 above. This allocation and the resulting available safety margin for the Murray County Area are discussed further in section VII of this proposed rulemaking. d. Monitoring Network There is currently one monitor measuring ozone in the Murray County Area. Murray County has committed in the maintenance plan to continue operation of this monitor in compliance with 40 CFR part 58, and has addressed the requirement for monitoring. e. Verification of Continued Attainment Georgia has the legal authority to enforce and implement the requirements of the ozone maintenance plan for the Murray County Area. This includes the authority to adopt, implement and enforce any subsequent emissions control contingency measures determined to be necessary to correct future ozone attainment problems. Georgia will track the progress of the maintenance plan by performing future reviews of actual emissions for the Area using the latest emissions factors, models and methodologies. For these periodic inventories Georgia will review the assumptions made for the purpose of the maintenance demonstration concerning projected growth of activity levels. If any of these assumptions appear to have changed substantially, Georgia will re-project emissions. f. Contingency Plan The contingency plan provisions are designed to promptly correct a violation of the NAAQS that occurs after redesignation. Section 175A of the CAA requires that a maintenance plan include such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation, and a time limit for action by the state. A state should also identify specific indicators to be used to determine when the contingency measures need to be implemented. The maintenance plan must include a requirement that a state will implement all measures with respect to control of the pollutant that were contained in the SIP before redesignation of the area to attainment in accordance with section 175A(d). In the June 15, 2007, submittal, Georgia affirms that all programs instituted by the State and EPA will remain enforceable, and that sources are prohibited from reducing emissions controls following the redesignation of the Murray County Area. In the submittal, if there is a measured violation of the 8-hour ozone NAAQS in the Murray County Area, contingency measures would be adopted and implemented as expeditiously as possible, but no later than eighteen to twenty four months after the triggering event. The proposed schedule for these actions would be as follows: • Six months to perform a comprehensive analysis; • Three months to identify potential sources for reductions; • Three months to identify applicable control measures; • Three months to initiate a stakeholder process; • Three months to draft SIP regulations; and • Six months to initiate the rulemaking process. This step would include the time required to hold a public comment period, hearing, and board adoption, and submit the final plans to EPA. This process may be initiated simultaneously with drafting the regulations. Georgia will consider one or more of the following contingency measures to re-attain the standard. • RACM for all sources of NO <sup>X</sup> • RACT for all existing point sources of NO <sup>X</sup> • Expansion of RACM/RACT to area(s) of transport within the State • Mobile Source Measures • Additional NO <sup>X</sup> reduction measures yet to be identified EPA has concluded that the maintenance plan adequately addresses the five basic components of a maintenance plan: attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and a contingency plan. The maintenance plan SIP revision submitted by Georgia for the Murray County Area meets the requirements of section 175A of the CAA and is approvable. VII. What Are the Proposed Regional MVEBs for the Murray County Area? Under the CAA, states are required to submit, at various times, control strategy SIPs and maintenance plans in ozone areas. These control strategy SIPs (reasonable further progress SIPs and attainment demonstration SIPs, etc.) and maintenance plans create MVEBs for criteria pollutants and/or their precursors to address pollution from cars and trucks. Per 40 CFR part 93, an MVEB is established for the last year of the maintenance plan. The MVEB is the portion of the total allowable emissions in the maintenance demonstration that is allocated to highway and transit vehicle use and emissions. See, 40 CFR 93.101. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188). The preamble also describes how to establish the MVEB in the SIP and revise the MVEB. Georgia, after interagency consultation with the transportation partners for the Murray County Area, has elected to develop regional MVEBs for NO <sup>X</sup> and VOCs for this Area. Georgia is developing these MVEBs, as required, for the last year of its maintenance plan (2018). The MVEBs reflect the total on-road emissions for 2018, plus an allocation from the available VOCs and NO <sup>X</sup> safety margin. Under 40 CFR 93.101, the term safety margin is the difference between the attainment level (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. The safety margin can be allocated to the transportation sector; however, the total emissions must remain below the attainment level. These MVEBs and allocation from the safety margin were developed in consultation with the transportation partners and were added to account for uncertainties in population growth, changes in model vehicle miles traveled
(VMT)and new emission factor models. The regional MVEBs for the Murray County Area are defined in Table 5 below. Table 5.—Murray County Area MVEBs [Tons per day] 2018* NO <sup>X</sup> 0.0129 VOCs 0.0117 * Includes an allocation for the available NO <sup>X</sup> and VOCs safety margins. As mentioned above, Georgia has chosen to allocate a portion of the available safety margin to the 2018 MVEBs. This allocation is 0.0056 tpd for NO <sup>X</sup> and 0.0042 tpd for VOCs. The 2018 regional MVEBs are derived as follows for NO <sup>X</sup> : (0.0073 tpd for total mobile emissions) + (0.0056 tpd from available safety margin) = 0.0129 tpd; and for VOCs: (0.0075 tpd for total mobile emissions) + (0.0042 tpd from available safety margin) = 0.0117 tpd. Thus, the remaining safety margin in 2018 is 0.0055 tpd for NO <sup>X</sup> and 0.0042 tpd for VOCs. Through this rulemaking, EPA is proposing to approve the 2018 regional MVEBs for NO <sup>X</sup> and VOCs for the Murray County Area because EPA has determined that the Area maintains the 8-hour ozone standard with the emissions at the levels of the budgets. As mentioned above, these MVEBs are regional MVEBs for the Murray County Area. Once the new regional MVEBs for the Murray County Area (the subject of this rulemaking) are approved or found adequate (whichever is done first), they must be used for future conformity determinations. As is discussed in greater detail below, EPA is also announcing the status of its adequacy determination for the proposed 2018 MVEBs for the Murray County Area pursuant to 40 CFR 93.118(f)(1). VIII. What Is the Status of EPA's Adequacy Determination for MVEBs for the Year 2018 for the Murray County Area? Under section 176(c) of the CAA, new transportation projects, such as the construction of new highways, must “conform” to ( *i.e.* , be consistent with) the part of the State's air quality plan that addresses pollution from cars and trucks. “Conformity” to the SIP means that transportation activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS. If a transportation plan does not “conform,” most new projects that would expand the capacity of roadways cannot go forward. Regulations at 40 CFR part 93 set forth EPA policy, criteria, and procedures for demonstrating and assuring conformity of such transportation activities to a SIP. The regional emissions analysis is one, but not the only, requirement for implementing transportation conformity. Transportation conformity is a requirement for nonattainment and maintenance areas. Maintenance areas are areas that were previously nonattainment for a particular NAAQS but have since been redesignated to attainment with a maintenance plan for that NAAQS. When reviewing submitted “control strategy” SIPs or maintenance plans containing MVEBs, EPA must affirmatively find the MVEB contained therein “adequate” for use in determining transportation conformity. Once EPA affirmatively finds the submitted MVEB is adequate for transportation conformity purposes, that MVEB can be used by state and Federal agencies in determining whether proposed transportation projects “conform” to the SIP as required by section 176(c) of the Clean Air Act. EPA's substantive criteria for determining “adequacy” of an MVEB are set out in 40 CFR 93.118(e)(4). The process for determining “adequacy” consists of three basic steps: public notification of a SIP submission, a public comment period, and EPA's adequacy finding. This process for determining the adequacy of submitted SIP MVEBs was initially outlined in EPA's May 14, 1999, guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision.” This guidance was finalized in the Transportation Conformity Rule Amendments for the “New 8-Hour Ozone and PM2.5 National Ambient Air Quality Standards and Miscellaneous Revisions for Existing Areas; Transportation Conformity Rule Amendments—Response to Court Decision and Additional Rule Change,” on July 1, 2004 (69 FR 40004). EPA follows this guidance and rulemaking in making its adequacy determinations. Georgia's maintenance plan submission contained new regional MVEBs for VOCs and NO <sup>X</sup> for the Murray County Area for the year 2018. The availability of the Georgia SIP submission with the Murray County MVEBs was available for public comment on EPA's adequacy Web site on June 21, 2007, at: * http:// www.epa.gov/otaq/stateresources/transconf/currsips.htm * . The EPA public comment period on adequacy of the 2018 regional MVEBs for the Murray County Area closed on July 23, 2007. EPA did not receive any comments, or requests for the submittal. EPA intends to make its determination of the adequacy of the 2018 MVEBs for the Murray County Area for transportation conformity purposes in the final rulemaking on the redesignation of the Murray County Area. If EPA finds the 2018 MVEBs adequate and approves these MVEBs in the final rulemaking action, the new MVEBs must be used for future transportation conformity determinations. The new 2018 MVEBs, if found adequate and approved in the final rulemaking, will be effective on the date of publication of EPA's final rulemaking in the **Federal Register** . For required regional emissions analysis years that involve the year 2017 or before, the State will use the interagency consultation group for this Area to determine the appropriate interim test to use to demonstrate conformity. For required regional emissions analysis years that involve 2018 or beyond, the applicable budgets will be the new 2018 MVEBs. The 2018 MVEBs are defined in section VII of this rulemaking. IX. Proposed Actions on the Redesignation Request and the Maintenance Plan SIP Revision Including Proposed Approval of the 2018 MVEBs EPA is proposing to make the determination that the Murray County Area has met the criteria for redesignation from nonattainment to attainment for the 8-hour ozone NAAQS. Further, EPA is proposing to approve Georgia's redesignation request for the Murray County Area. After evaluating Georgia's SIP submittal requesting redesignation, EPA has determined that it meets the redesignation criteria set forth in section 107(d)(3)(E) of the CAA. EPA believes that the redesignation request and monitoring data demonstrate that the Murray County Area has attained, and will continue to maintain the 8-hour ozone standard. EPA is also proposing to approve the June 15, 2007, SIP revision containing Georgia's 8-hour ozone maintenance plan for the Murray County Area. The maintenance plan includes regional MVEBs for 2018, among other requirements. EPA is proposing to approve the 2018 MVEBs for the Murray County Area, because the maintenance plan demonstrates that expected emissions for all other source categories will continue to maintain the 8-hour ozone standard. Further, as part of today's action, EPA is describing the status of its adequacy determination for the 2018 MVEBs in accordance with 40 CFR 93.118(f)(1). If transportation conformity is implemented in this Area, the transportation partners will need to use these new MVEBs pursuant to 40 CFR 93.104(e) as effectively amended by section 172(c)(2)(E) of the CAA as added by the Safe, Accountable, Flexible, Efficient Transportation Equity Act—A Legacy for Users (SAFETEA-LU), which was signed into law on August 10, 2005. X. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed action merely proposes to approve State law as meeting Federal requirements and imposes no additional requirements beyond those imposed by State law. Redesignation of an area to attainment under section 107(d)(3)(e) of the CAA does not impose any new requirements on small entities. Redesignation is an action that affects the status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule proposes to approve pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely affects the status of a geographical area, does not impose any new requirements on sources, or allow a state to avoid adopting or implementing other requirements and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant and because the Agency does not have reason to believe that the rule concerns an environmental health risk or safety risk that may disproportionately affect children. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the CAA. Redesignation is an action that affects the status of a geographical area but does not impose any new requirements on sources. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. 40 CFR Part 81 Environmental protection, Air pollution control, National parks, Wilderness areas. Authority: 42 U.S.C. 7401 *et seq.* Dated: August 16, 2007. J.I. Palmer, Jr., Regional Administrator, Region 4. [FR Doc. E7-17133 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0182; FRL-8143-3] Dibasic Esters (CAS Reg. No. 95481-62-2); Proposed Pesticide Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: This document proposes to establish an exemption from the requirement of a tolerance for residues of dibasic esters (DBE; CAS Reg. No. 95481-62-2) under 40 CFR 180.1277 when used as an inert ingredient solvent material/anti-freeze microencapsulated at 10% weight/weight (W/W) or less in pesticide formulations with the active ingredient cyfluthrin. Whitmire Micro-Gen Research Laboratories, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. New data were received by EPA after the publication of the petitoner's Notice of Filing, therefore, EPA is providing the public with an additional opportunity to comment on the petitioner's request in this proposed rule. DATES: Comments must be received on or before October 29, 2007. ADDRESSES: Submit your comments, identified by docket identification
(ID)number EPA-HQ-OPP-2007-0182, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is
(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2007-0182. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, 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 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: Tracy Ward, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone number:
(703)308-9361; e-mail address: *ward.tracyh@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II. 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. What Should I Consider as I Prepare My Comments for EPA? 1. * Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. * Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background and Statutory Findings In the **Federal Register** of December 23, 1998 (63 FR 71126) (FRL-6047-7), EPA issued a notice under section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5E4442) by Whitmire Micro-Gen Research Laboratories, Inc., 3568 Tree Court Industrial Blvd., St. Louis, MO 63122-6682. The petition requested that 40 CFR 180.910 and 180.930 be amended by establishing a tolerance for residues of the inert ingredient DBE. This notice included a summary of the petition prepared by Whitmire Micro-Gen Research Laboratories, Inc., the petitioner. There were no comments received in response to the notice of filing. The typical process used by EPA in considering new tolerance exemptions for inert ingredients is to publish the petition for public comment in a Notice of Filing, evaluate the available data and information on the chemical, and publish a final rule in the **Federal Register** if the Agency concludes that a tolerance exemption can be established. In the case of DBE, a significant number of new studies on DBE were received by EPA after the publication of the Notice of Filing [see the **Federal Register** of August 5, 1999 (64 FR 42692)] in which the Agency issued a testing consent order incorporating an enforceable consent agreement
(ECA)under section 4 of the Toxic Substance Control Act (TSCA). EPA reviewed the new data [see the **Federal Register** of August 17, 2005 (70 FR 48418)] and considered the study results in evaluating this petition. The Agency and the U.S. Consumer Product Safety Commission
(CPSC)agreed that all testing requirements were completed, and that a third testing phase ( *in vivo* dermal penetration rate testing) was unnecessary. Considering this new data were not part of the December 23, 1998 Notice of Filing, EPA is providing the public with an additional opportunity to comment on the petitioner's request to establish a tolerance exemption for DBE by proposing to establish a tolerance exemption for DBE in this document. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “ there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Risk Characterization and Conclusions 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 nature of the toxic effects caused by the dibasic esters
(DBE)are discussed in this unit. EPA has sufficient data to assess the hazards of, and to make a determination on, aggregate exposure for this chemical. The following provides a brief summary of the risk assessment and conclusions for the Agency's review of DBE. The full decision document for this action is available on EPA's Electronic Docket at *http://www.regulations.gov/* under docket number EPA-HQ-OPP-2007-0182. A. Human Health The Agency reviewed the information submitted by the petitioner as well as additional information available to the Agency and has determined that DBE has low acute oral and inhalation toxicity and low subchronic oral toxicity with a no observed adverse effect level (NOAEL) of 842 mg/kg/day. In acute eye toxicity studies on the rabbit, DBE had mild to moderate eye irritation. In subchronic inhalation studies, DBE had a systemic inhalation NOAEL ≥ 0.40 mg/L (400 milligrams/milliliter (mg/m 3 )), but a nasal irritation NOAEL < 0.02 mg/L (20 mg/m 3 ). DBE did not induce neurotoxicity or carcinogenicity in the studies reviewed, and it was negative for mutagenicity in most tests, but positive for chromosomal aberrations under activated conditions. In a repeat-dose inhalation reproduction toxicity study, DBE had a NOAEL of 0.40 mg/L (400 mg/m 3 ) and a Lowest effect level
(LEL)of 1.0 mg/L (1,000 mg/m 3 ) based on decreased pup weights at weaning. In repeat-dose inhalation exposure studies, developmental toxicity was observed at higher doses (1.0 mg/L or 1,000 mg/m3) than maternal toxicity (0.16 mg/L or 160 mg/m 3 ). In studies, DBE did not cause dermal irritation in animals exposed for four hours, but caused severe irritation (severe erythema and mild edema) in one animal and reversible mild to moderate irritation in animals exposed to DBE for 24 hours. DBE was not considered to be a skin-sensitizer in guinea pigs. In repeat-dermal exposure studies conducted on the rat, DBE had a systemic dermal NOAEL of 1,000 mg/kg/day, and dermal irritation lowest observed adverse effect level (LOAEL) of 100 mg/kg/day based on the slight, but reversible, erythema and edema. B. Exposure Assessment The use of DBE in pesticide products is being limited to 10% or less of microencapsulated pesticide formulations with the insecticide active ingredient cyfluthrin. Uses of cyfluthrin are currently limited to food-use applications such as spot and crack and crevice treatments in food processing plants and food storage areas, and it is typically applied by commercial applicators. Dietary exposures of concern from residues in food and drinking water are not anticipated. The microencapsulated formulation and its restriction to use with one active ingredient will reduce the potential for residential exposures (inhalation and dermal) to a minimal level. DBE is also used in non-pesticide consumer products such as paint solvents. The use of DBE as an inert ingredient in pesticide formulations, with the above limitations, is not expected to contribute significantly to exposures from its use in non-pesticide consumer products. C. Safety Factor for Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. The toxicity database is sufficient for DBE and potential exposure is adequately characterized based on the low use rate. In terms of hazard, there are low concerns and no residual uncertainties regarding prenatal and/or postnatal toxicity. D. Cumulative Exposure Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to DBE and any other substances, and the chemical 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 DBE 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 EPA's website at *http://www.epa.gov/pesticides/cumulative* . E. Other Considerations 1. *Analytical methods* . Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . Residues are not expected because of the low amount that will be permitted in the pesticide formulation (limited to 10% W/W or less) and the limitation of use with one pesticide active ingredient. 2. *International tolerances* . The Agency is not aware of any country requiring a tolerance for DBE, nor have any CODEX Maximum Residue Levels
(MRLs)been established for any food crops at this time. F. Determination of Safety and Conclusions Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm to the general population, including infants and children, from aggregate exposure to residues of DBE. Accordingly, EPA finds that exempting DBE from the requirement of a tolerance will be safe. IV. Conclusion A tolerance exemption is proposed for residues of DBE when it is used as an inert ingredient solvent material/anti-freeze microencapsulated at 10% W/W or less in pesticide formulations with the active ingredient cyfluthrin. V. Statutory and Executive Order Reviews This action proposes to establish a tolerance exemption 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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 proposed 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 104-13, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. Establishing a pesticide tolerance or an exemption from the requirement of a pesticide tolerance is, in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including small entities. 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 proposed 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 proposed 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 proposed 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 proposed rule. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 20, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be 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 180.1277 is added to subpart D to read as follows: § 180.1277 Dibasic esters; Exemption from the requirement of a tolerance. Dibasic esters (CAS Reg. No. 95481-62-2) is exempted from the requirement of a tolerance for residues when used as an inert ingredient (solvent material/anti-freeze) at 10% W/W or less in microencapsulated pesticide formulations with the active ingredient cyfluthrin. [FR Doc. E7-17109 Filed 8-28-07; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-3559; MB Docket No. 07-164; RM-11386] Radio Broadcasting Services; Peach Springs, Arizona AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY: This document requests comments on a petition for rulemaking filed by Smoke and Mirrors LLC, requesting the substitution Channel 268C3 for vacant Channel 285C3 at Peach Springs, Arizona, and to amend the reference coordinates for that allotment. Channel 268C3 can be allotted at reference coordinates 35-29-35 NL and 113-35-17 WL. DATES: Comments must be filed on or before October 1, 2007, and reply comments on or before October 16, 2007. ADDRESSES: Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve the petitioner's counsel as follows: Robert L. Olender, Esq., Koerner & Olender, P.C., 11913 Grey Hollow Court, North Bethesda, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Deborah A. Dupont, Media Bureau,
(202)418-7072. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's Notice of Proposed Rule Making, MB Docket No. 07-164, adopted August 8, 2007, and released August 10, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street, SW., Washington, DC 20554. This document may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *www.BCPIWEB.com.* This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of l980 do not apply to this proceeding. Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all *ex parte* contacts are prohibited in Commission proceedings, such as this one, which involve channel allotments. See 47 CFR 1.1204(b) for rules governing permissible *ex parte* contacts. For information regarding proper filing procedures for comments, see 47 CFR 1.415 and 1.420. List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR Part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202 [Amended] 2. Section 73.202(b), the Table of FM Allotments under Arizona is amended by removing Channel 285C3 and adding Channel 268C3 at Peach Springs. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-17014 Filed 8-28-07; 8:45 am] BILLING CODE 6712-01-P 72 167 Wednesday, August 29, 2007 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Docket No. AMS-FV-0109; FV07-900-1NC] Notice of Request for Extension and Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the Agricultural Marketing Service's
(AMS)intention to request an extension for an revision to a currently approved information collection enabling certified organic handlers exemption from paying market promotion assessments under 26 Federal marketing order programs. DATES: Comments on this notice must be received by October 29, 2007. ADDRESSES: Interested persons are invited to submit written comments concerning this notice. Comments must be sent to the Docket Clerk, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237; Fax:
(202)720-8938; or Internet: *http://www.regulations.gov.* Comments should reference the docket number and the date and page number of this issue of the **Federal Register** and will be available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: *http://www.regulations.gov.* FOR FURTHER INFORMATION CONTACT: Sue Challis, Supervisory Marketing Specialist, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA; Telephone:
(202)720-2491, Fax:
(202)720-8938, or E-mail: *Sue.Challis@usda.gov.* Small businesses may request information on this notice by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, room 1406-S, Washington, DC 20250-0237; telephone
(202)720-2491, Fax:
(202)720-8938, or E-mail: *Jay.Guerber@usda.gov.* SUPPLEMENTARY INFORMATION: *Title:* Certified Organic Handler Market Promotion Assessment Exemption under 26 Federal Marketing Orders. *OMB Number:* 0581-0216. *Expiration Date of Approval:* January 31, 2008. *Type of Request:* Extension and revision of a currently approved information collection. *Abstract:* Marketing order programs provide and opportunity for producers of fresh fruit, vegetables, and specialty crops, in specified production areas, to work together to solve marketing problems that cannot be solved individually. This notice covers the following marketing order program citations under 7 CFR: Part 906, Texas citrus; part 915, Florida avocados; part 916, California nectarines; part 917, California peaches and pears; part 922, Washington apricots; part 923, Washington sweet cherries; part 924, Washington/Oregon fresh prunes; part 925, California grapes; part 927, Pears Grown in Oregon and Washington; part 929, Cranberries Grown in States of Massachusetts, *et al.* ; part 930, Tart Cherries Grown in the States of Michigan, *et al.* ; part 932, California olives; part 947, Oregon/California potatoes; Part 948, Colorado potatoes; part 955, Vidalia Onions, part 956, Washington/Oregon Walla Walla onions, part 958, Idaho-Eastern Oregon onions; part 959, Texas onions; part 966, Florida tomatoes; part 981, California almonds; part 982, Oregon-Washington hazelnuts; part 984, California walnuts; part 985, Far West spearmint oil, part 987, California dates; part 989, California raisins; and part 993, California dried prunes. Marketing orders 931 and 979 were previously included, however, these programs have since terminated. Order regulations help ensure adequate supplies of high quality products for consumers and adequate returns to producers. Under the Agricultural Marketing Agreement Act of 1937 (Act), as amended (7 U.S.C. 601-674), orders may authorize production and marketing research, including paid advertising. Production and marketing research and development, including paid advertising activities to promote the various commodities, are paid for with assessments levied on handlers regulated under the 26 Federal marketing orders. On May 13, 2002, section 501 of the FAIR Act was amended (7 U.S.C. 7401) to exempt any person that produces and markets solely 100 percent organic products, and that does not produce any conventional or non-organic products, from paying assessments under a commodity promotion law with respect to any agricultural commodity that is produced on a certified organic farm as defined in Section 2103 of the Organic Foods Production Act of 1990 (7 U.S.C. 6502). To be exempt from paying assessments for marketing promotion, including paid advertising expenses, under the specified marketing orders, the certified organic handler must submit an application, “Certified Organic Handler Application for Exemption from Market Promotion Assessments Paid Under Federal Marketing Orders” to the marketing order committee or board. The information request includes the following: Handler's name (applicant); telephone and fax numbers, and an optional e-mail address; name and address of the company; certification that the applicant operates under an approved organic process system plan authorized by the National Organic Program
(NOP)and handles products that are eligible to be labeled as 100 percent organic, that the applicant is not a split operation as defined by the Organic Food Production Act of 1990
(OFPA)and the NOP, and that the applicant is subject to assessments under the Federal marketing order program for which this exemption is requested. A table has been added to the application for the applicant to list all commodities handled and to indicate whether each commodity handled is eligible to be labeled as 100 percent organic. The application requires the applicant to list the number of producers for whom the applicant handles or markets products. The applicant also is required to attach a copy of the organic handling operation certificate provided by a USDA-accredited certifying agent under the OFPA and the NOP, and a copy of the applicant's NOP producer certificate, if applicable. An NOP certificate for each producer for whom the applicant handles also must be attached. When the requirements for exemption no longer apply to a handler, the handler shall inform the committee or board within 30 days and pay the full assessment on all remaining assessable product for all committee or board assessments from the date the handler no longer is eligible to the end of the assessment period. The notification by the handler can be made in any manner the handler desires (telephone, fax, e-mail, etc.). This information is necessary to help the committees or boards to determine an applicant's eligibility and to verify compliance. Inclusion of this information on the form assists the applicants in making their certifications and the committee or boards in properly administering the assessment exemption. The respective marketing orders ( *e.g.* 7 CFR 932.61 and 7 CFR 981.70) also provide that handlers maintain, and make available, all records necessary to demonstrate compliance with order requirements for two years. The burdens on handlers for such recordkeeping requirements are included in the information collection requests previously approved by OMB for the respective marketing orders under the following OMB Control Numbers: OMB No. 0581-0178 for marketing order Nos. 932, 947, 948, 955, 956, 958, 959, 966, 981, 982, 984, 985, 987, 989, and 993; OMB No. 0581-0189 for marketing order Nos. 906, 915, 916, 917, 922, 923, 924, 925, 927, 929, and 930. The information collected is used only by authorized representatives of the USDA, including AMS, Fruit and Vegetable Programs’ regional and headquarters’ staff and authorized committee/board employees. Authorized committee/board employees are the primary users of the information and AMS is the secondary user. AMS is committed to complying with the E-Government ACT, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. *Estimate of Burden:* Public reporting burden for this collection of information is estimated to average 30 minutes per response. *Respondents:* Eligible Certified Organic Handlers. *Estimated Number of Respondents:* 103. *Estimated Number of Total Annual Responses:* 103. *Estimated Number of Responses per Respondent:* 1. *Estimated total Annual Burden on Respondents:* 52 hours. *Comments are invited on:*
(1)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments should reference this docket number and the appropriate marketing order and be sent to the USDA in care of the Docket Clerk at the address above. All comments received will be available for public inspection during regular business hours at the same address. All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Dated: August 23, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. 07-4241 Filed 8-28-07; 8:45 am]
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Traces to 34 documents
U.S. Code
- Definitions§ 632
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Purposes§ 3501
- Definitions§ 601
- Establishment, functions, and activities§ 272
- SHORT TITLE.§ 801
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Definitions; generally§ 321
- Definitions§ 136
- Owners engaged primarily in leasing or financing transactions§ 12119
- Surrender of title and number§ 12106
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Federal Communications Commission§ 154
- Federal Aviation Administration§ 106
- Congressional findings and declaration of purpose§ 7401
- Federal agency responsibilities§ 3506
- Commodity promotion and evaluation§ 7401
- Definitions§ 6502
register
CFR
- Petition for rulemaking—requirements for filing.§ 2.802
- Notice of hearing.§ 2.104
- Filing of application.§ 2.101
- Completeness and accuracy of information.§ 60.10
- Completeness and accuracy of information.§ 63.10
- Construction authorization.§ 60.31
- Construction authorization.§ 63.31
- Scope of subpart G.§ 2.700
- Applicability.§ 71.1
- National 8-hour primary and secondary ambient air quality standards for ozone.§ 50.10
47 references not yet in our index
- 13 CFR 121
- 5 USC 601-612
- Pub. L. 105-135
- 40 CFR 180
- 40 CFR 180.491
- 40 CFR 178
- 40 CFR 2
- Pub. L. 104-4
- Pub. L. 104-113
- 40 CFR 180.495
- 40 CFR 166
- 46 CFR 68.65
- 46 CFR 68.70
- 46 CFR 68.75
- 46 CFR 68.100
- 46 CFR 68.107
- 46 CFR 68.109
- 47 CFR 73
- 50 CFR 92
- 10 CFR 2
- 10 CFR 60
- 10 CFR 51
- 111 Stat. 2592
- 14 CFR 71
- 40 CFR 50
- 472 F.3d 882
- 375 F.3d 537
- 285 F.3d 63
- 40 CFR 81
- 40 CFR 93.118(f)(1)
- 40 CFR 58
- 265 F.3d 426
- 144 F.3d 984
- 40 CFR 93
- 40 CFR 93.101
- 40 CFR 93.118(e)(4)
- 40 CFR 93.104(e)
- 40 CFR 52
- 40 CFR 180.1277
- 40 CFR 180.910
+ 7 more
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Direct final rule
F. App'x472 F.3d 882
F. App'x375 F.3d 537
F. App'x285 F.3d 63
Cites 81 · showing 12Cited by 0 across 0 sources