Unknown. Final rule
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/register/2007/08/22/07-4107A 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-2007-08-22.xml --- 72 162 Wednesday, August 22, 2007 Contents Agency Agency for Toxic Substances and Disease Registry NOTICES Hazardous substances releases and facilities: Public health assessments and effects; list, 47042-47044 E7-16548 Agriculture Agriculture Department See Forest Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 46952 E7-16563 Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 47044-47045 E7-16591 Meetings:
National Institute for Occupational Safety and Health— Radiation and Worker Health Advisory Board, 47045 E7-16557 Centers Centers for Medicare & Medicaid Services RULES Medicare: Hospital inpatient prospective payment systems and 2008 FY rates, 47568-48175 07-3820 NOTICES Privacy Act; systems of records, 47045-47050 07-4076 Children Children and Families Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 47050 07-4110 Civil Civil Rights Commission NOTICES Meetings;
State advisory committees: Hawaii, 46953 E7-16544 Coast Guard Coast Guard RULES Drawbridge operations: Louisiana, 46896-46897 E7-16493 Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.: Upper Potomac River, Washington, DC, 46897-46899 E7-16479 Commerce Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 46953-46954 E7-16545 Defense Defense Department PROPOSED RULES Federal Acquisition Regulation (FAR):
Enhanced access for small business, 46950-46951 07-4077 Delaware Delaware River Basin Commission PROPOSED RULES Water Quality Regulations, Water Code, and Comprehensive Plan: Lower Delaware River; designation as Special Protection Water extended, 46931-46932 E7-16549 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 46968 E7-16578 Grants and cooperative agreements; availability, etc.: Special education and rehabilitative services— Small Business Innovative Research Program, 46968-46973 E7-16609 Meetings:
Student Financial Assistance Advisory Committee, 46973 E7-16567 Employment Employment Standards Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 47079 E7-16533 Energy Energy Department See Federal Energy Regulatory Commission NOTICES Meetings: Environmental Management Advisory Board, 46974-46975 E7-16552 Environmental Management Site-Specific Advisory Board— Northern New Mexico, 46973-46974 E7-16551 Oak Ridge Reservation, TN, 46975 E7-16553 Patent licenses; non-exclusive, exclusive, or partially exclusive:
Onyx Optics, Inc., 46975-46976 E7-16550 EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States: South Carolina, 46903-46905 E7-16316 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Buprofezin, 46905-46906 E7-16604 Fipronil, 46906-46914 E7-16621 Pyriproxyfen, 46914-46919 E7-16310 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: South Carolina, 46939 E7-16315 NOTICES Agency information collection activities; proposals, submissions, and approvals, 46991-46994 E7-16596 E7-16610 Committees; establishment, renewal, termination, etc.:
National Environmental Justice Advisory Council, 46994-46995 E7-16613 Meetings: Scientific Counselors Board, 46996 E7-16608 Pesticide, food, and feed additive petitions: Bayer CropScience, 47008-47010 E7-16559 Interregional Research Project (No. 4) et al., 47010-47012 E7-16561 Pesticide registration, cancellation, etc.: ADBAC, etc., 46996-47007 E7-16560 Pesticides; emergency exemptions, etc.: Coumaphos, etc., 47012-47017 E7-16452 E7-16562 Diuron, etc., 47017-47023 E7-16312 Radiation protection programs:
Transuranic radioactive waste for disposal at Waste Isolation Pilot Plant; waste characterization program documents availability— Los Alamos National Laboratory, NM; Central Characterization Project Remote-Handled Waste Characterization Program, 47023-47026 E7-16612 Toxic and hazardous substances control: New chemicals— Receipt and status information, 47026-47037 E7-16318 FAA Federal Aviation Administration PROPOSED RULES Class E airspace, 46930-46931 07-4107 NOTICES Aeronautical land-use assurance; waivers:
Lonesome Pine Airport, VA, 47119-47120 07-4105 Airport noise compatibility program: Austin-Bergstrom International Airport, TX, 47118-47119 07-4106 Meetings: Grand Canyon Working Group, 47120 07-4104 FBI Federal Bureau of Investigation NOTICES Privacy Act; systems of records, 47073-47079 E7-16487 FCC Federal Communications Commission RULES Common carrier services: Federal-State Joint Board on Universal Service— Rural high-cost universal service; Multi-Association Group plan; correction, 46919-46920 E7-16569 Telecommunications Act of 1996; implementation— Universal service policy; correction, 46920 E7-16573 PROPOSED RULES Common carrier services:
Satellite communications— Broadcasting-satellite service; policies and service rules, 46939-46949 E7-16565 Radio stations; table of assignments: Colorado, 46949 E7-16568 Texas, 46949-46950 E7-16566 NOTICES Agency information collection activities; proposals, submissions, and approvals, 47037-47039 E7-16303 E7-16570 E7-16571 Radio broadcasting: NCE FM new station applications in October 12-19, 2007 window; application limit, 47039-47040 E7-16457 Federal Emergency Federal Emergency Management Agency NOTICES Grants and cooperative agreements; availability, etc.:
Disaster Housing Assistance Program, 47060-47061 E7-16602 Federal Energy Federal Energy Regulatory Commission NOTICES Complaints filed: Nexen Marketing U.S.A., Inc., 46987 E7-16504 Xcel Energy Services Inc., 46987 E7-16535 Electric rate and corporate regulation combined filings, 46988-46989 E7-16536 Environmental statements; notice of intent: Northern Natural Gas Co., 46989-46990 E7-16523 Hydroelectric applications, 46990-46991 E7-16506 Meetings: New York Independent System Operator, Inc.; technical conference, 46991 E7-16502 *Applications, hearings, determinations, etc.:* ANR Pipeline Co. et al., 46976 E7-16519 Basin Electric Power Cooperative, 46976 E7-16503 Bridgeline Holdings, L.P., 46977 E7-16534 CCPS Transportation, LLC, 46977 E7-16505 CenterPoint Energy Gas Transmission Co., 46977-46978 E7-16498 E7-16518 Columbia Gas Transmission Corp., 46978-46979 E7-16497 Crossroads Pipeline Co., 46979 E7-16517 Dominion Cove Point LNG, LP, 46979 E7-16510 Gulf South Pipeline Co., LP, 46979-46980 E7-16513 E7-16514 High Island Offshore System L.L.C., 46980-46981 E7-16521 Kinder Morgan Interstate Gas Transmission LLC, 46981 E7-16495 Northern Natural Gas Co., 46981-46982 E7-16520 E7-16522 PacifiCorp, 46982 E7-16501 PetroLogistics Natural Gas Storage, LLC, 46982-46983 E7-16496 Pine Prairie Energy Center, LLC, 46983 E7-16515 Rockies Express Pipeline LLC, 46983-46984 E7-16507 E7-16508 E7-16516 Sabine Pipe Line LLC, 46985 E7-16509 Southern Company Services, Inc., 46985 E7-16500 Transwestern Pipeline Co., LLC, 46985 E7-16511 Tuscarora Gas Transmission Co., 46986 E7-16512 Williston Basin Interstate Pipeline Co., 46986-46987 E7-16499 Federal Highway Federal Highway Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 47120-47121 E7-16478 Environmental statements; notice of intent:
Atlanta, GA to Chattanooga, TN; high-speed ground transportation, 47121-47122 07-4109 New London County, CT, 47119 07-4127 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 47041 E7-16597 Ocean transportation intermediary licenses: Amber Freight Shipping Lines et al., 47041 E7-16599 Federal Motor Federal Motor Carrier Safety Administration NOTICES Meetings; Sunshine Act, 47122-47123 07-4137 Federal Railroad Federal Railroad Administration NOTICES Environmental statements; notice of intent:
Atlanta, GA to Chattanooga, TN; high-speed ground transportation, 47121-47122 07-4109 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Change in bank control, 47041-47042 E7-16441 Formations, acquisitions, and mergers, 47042 E7-16539 Formations, acquisitions, and mergers; correction, 47042 E7-16540 Formations, acquisitions, and mergers, 47042 E7-16442 Federal Transit Federal Transit Administration NOTICES Grants and cooperative agreements; availability, etc.:
Bus and Bus Facilities Program and Alternatives Analysis Program, 47123-47125 07-4125 Fish Fish and Wildlife Service PROPOSED RULES Endangered and threatened species: Critical habitat designations— Bay checkerspot butterfly, 48178-48218 07-4060 NOTICES Comprehensive conservation plans; availability, etc.: Carolina Sandhills National Wildlife Refuge, SC, 47062 E7-16611 Rachel Carson National Wildlife Refuge, ME, 47062-47063 E7-16614 Vieques National Wildlife Refuge, PR, 47063-47064 E7-16542 Endangered and threatened species:
Recovery plans— Ivory-billed woodpecker, 47064-47065 E7-16622 Food Food and Drug Administration RULES Food additives: Glycerol ester of tall oil rosin, 46895-46896 E7-16558 NOTICES Agency information collection activities; proposals, submissions, and approvals, 47051-47053 E7-16603 Forest Forest Service NOTICES Meetings: Resource Advisory Committees— North Central Idaho, 46953 07-4117 Rogue/Umpqua, 46952-46953 07-4113 GSA General Services Administration PROPOSED RULES Federal Acquisition Regulation (FAR):
Enhanced access for small business, 46950-46951 07-4077 Geological Geological Survey NOTICES Agency information collection activities; proposals, submissions, and approvals, 47065-47066 07-4118 Meetings: Scientific Earthquake Studies Advisory Committee, 47066 07-4112 Health Health and Human Services Department See Agency for Toxic Substances and Disease Registry See Centers for Disease Control and Prevention See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration Homeland Homeland Security Department See Coast Guard See Federal Emergency Management Agency See U.S.
Citizenship and Immigration Services PROPOSED RULES Privacy Act; implementation, 46921-46922 E7-16461 NOTICES Privacy Act; systems of records, 47057-47060 E7-16473 Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 47061-47062 E7-16483 Interior Interior Department See Fish and Wildlife Service See Geological Survey See Land Management Bureau See Reclamation Bureau IRS Internal Revenue Service PROPOSED RULES Income taxes:
Partner's distributive share, 46932-46939 E7-16189 International International Trade Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 46954 E7-16572 Antidumping: Carbazole violet pigment 23 from— India, 46954-46955 E7-16577 Frozen warmwater shrimp from— China, 46955-46957 E7-16576 Wooden bedroom furniture from— China, 46957-46966 E7-16584 International International Trade Commission NOTICES Import investigations: Lighting products, components, and products containing same, 47072 E7-16546 Nitrile rubber gloves, 47072-47073 E7-16432 Justice Justice Department See Federal Bureau of Investigation Labor Labor Department See Employment Standards Administration See Mine Safety and Health Administration See Occupational Safety and Health Administration Land Land Management Bureau NOTICES Closure of public lands:
Idaho, 47066-47067 E7-16620 Disclaimer of interest applications: Alaska, 47067-47068 E7-16491 E7-16492 Arizona, 47068 E7-16488 California, 47069 E7-16486 Mine Mine Safety and Health Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 47080-47081 E7-16453 E7-16454 NASA National Aeronautics and Space Administration PROPOSED RULES Federal Acquisition Regulation (FAR): Enhanced access for small business, 46950-46951 07-4077 NIH National Institutes of Health NOTICES Meetings:
National Institute on Deafness and Other Communication Disorders, 47053 07-4101 NOAA National Oceanic and Atmospheric Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 46966 E7-16543 Endangered and threatened species: Recovery plans— Hawaiian monk seal; 5-year review, 46966-46968 E7-16600 National Science National Science Foundation NOTICES Meetings: Astronomy and Astrophysics Advisory Committee, 47083 E7-16474 Nuclear Nuclear Regulatory Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 47083-47084 E7-16547 Meetings;
Sunshine Act, 47084 07-4132 Occupational Occupational Safety and Health Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 47081-47083 E7-16437 Overseas Overseas Private Investment Corporation NOTICES Agency information collection activities; proposals, submissions, and approvals, 47084-47085 07-4102 07-4103 Patent Patent and Trademark Office RULES Patent cases: Fee revisions (2007 FY), 46899-46903 E7-16574 Railroad Railroad Retirement Board NOTICES Agency information collection activities; proposals, submissions, and approvals, 47085-47086 E7-16590 E7-16592 Reclamation Reclamation Bureau NOTICES Central Valley Project Improvement Act; implementation:
Water management plans; district plans available for review, 47069-47070 E7-16616 Contract negotiations: Water service, repayment, and other water-related contract negotiations; quarterly status report, 47070-47072 07-4086 SEC Securities and Exchange Commission NOTICES Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 47086-47092 E7-16468 E7-16526 E7-16556 Boston Stock Exchange, Inc., 47092-47094 E7-16530 Chicago Board Options Exchange, Inc., 47094-47102 E7-16532 E7-16582 E7-16587 Financial Industry Regulatory Authority, Inc., 47102-47103 E7-16531 International Securities Exchange, LLC, 47104-47107 E7-16524 E7-16527 New York Stock Exchange LLC, 47107-47109 E7-16555 NYSE Arca, Inc., 47109-47112 E7-16528 E7-16580 Philadelphia Stock Exchange, Inc., 47112-47115 E7-16525 E7-16529 State State Department NOTICES Culturally significant objects imported for exhibition:
Artisans and Kings: Selected Treasures from the Louvre, 47115-47116 E7-16586 Khatchkar of Gtic, 47116 E7-16588 Medieval and Renaissance Treasures from the Victoria and Albert Museum, 47116 E7-16585 Reports and guidance documents; availability, etc.: 2008 Universal Postal Union Congress; proposals, 47116-47117 E7-16595 Substance Substance Abuse and Mental Health Services Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 47053-47057 E7-16537 E7-16538 E7-16541 Surface Surface Transportation Board NOTICES Railroad services abandonment:
Southwestern Railroad Co., Inc., 47126 E7-16213 Toxic Toxic Substances and Disease Registry Agency See Agency for Toxic Substances and Disease Registry Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration See Federal Railroad Administration See Federal Transit Administration See Surface Transportation Board NOTICES Meetings: National Surface Transportation Infrastructure Financing Commission, 47117 E7-16480 Senior Executive Service Performance Review Boards; membership, 47117-47118 E7-16564 Treasury Treasury Department See Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 47126-47127 07-4099 U.S.
U.S. Citizenship and Immigration Services PROPOSED RULES Immigration: Aliens— Permanent Resident Cards (Forms I-551) without expiration dates; replacement application process, 46922-46930 E7-16311 Veterans Veterans Affairs Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 47127-47128 E7-16484 E7-16485 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 47568-48175 07-3820 Part III Interior Department, Fish and Wildlife Service, 48178-48218 07-4060 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. 72 162 Wednesday, August 22, 2007 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. 2006F-0225] Food Additives Permitted for Direct Addition to Food for Human Consumption;
Glycerol Ester of Tall Oil Rosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the food additive regulations to provide for the safe use of glycerol ester of tall oil rosin (GETOR) to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. This action is in response to a petition filed by Georgia-Pacific Resins, Inc. DATES: This rule is effective August 22, 2007. Submit written or electronic objections and requests for a hearing by September 21, 2007. See section VI of this document for information on the filing of objections. ADDRESSES: You may submit written or electronic objections and requests for a hearing, identified by Docket No. 2006F-0225, by any of the following methods: Electronic Submissions Submit electronic objections in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written objections in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of objections, FDA is no longer accepting objections submitted to the agency by e-mail. FDA encourages you to continue to submit electronic objections by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and docket number for this rulemaking. All objections received will be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For detailed instructions on submitting objections, see the “Objections” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or objections received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Blondell Anderson, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1304. SUPPLEMENTARY INFORMATION: I. Background In a notice published in the **Federal Register** of June 15, 2006 (71 FR 34623), FDA announced that a food additive petition (FAP 6A4765) had been filed by Georgia-Pacific Resins, Inc., P.O. Box 105734, Atlanta, GA 30348. The petition proposed to amend the food additive regulations in 21 CFR 172.735 (§ 172.735) *Glycerol ester of wood or gum rosin* to provide for the following:
(1)The safe use of GETOR to adjust the density of citrus oils used in the preparation of beverages; and
(2)the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. GETOR, as well as glycerol ester of wood rosin
(GEWR)and glycerol ester of gum rosin (GEGR), are approved for use in chewing gum bases (§ 172.615 (21 CFR 172.615)) and for several indirect additive uses (e.g., 21 CFR 175.125 and 178.3870). The proposed additive, GETOR, is intended to substitute for GEWR or GEGR in adjusting the density of citrus oils used in the preparation of beverages at the same use level (up to 100 parts per million of the finished beverage). On March 29, 2005, FDA published a final rule that amended § 172.735 by approving the use of GEGR as a substitute for GEWR for adjusting the density of citrus oils in the preparation of beverages (70 FR 15756). The rule was issued in response to a petition and was based on FDA's conclusion that GEGR is chemically similar to GEWR, such that any increase in the estimated daily intake
(EDI)of the individual resin acids and resin acid esters (the major components of both GEGR and GEWR) would be insignificant and of no toxicological concern. The current petitioner has taken a similar approach to demonstrate that GETOR may be safely substituted for GEWR, and thereby for GEGR. II. Evaluation of Safety The petitioner provided information concerning the following:
(1)The chemical composition of GETOR in comparison with GEWR;
(2)the process used to manufacture GETOR;
(3)physiochemical properties of GETOR in comparison to GEWR;
(4)conformance of GETOR with the specifications in § 172.735;
(5)the functional equivalence of GETOR to GEWR; and
(6)relevant safety information. Based on its evaluation of the information provided by the petitioner and other available information, the agency has determined that GETOR is chemically and functionally similar to GEWR and GEGR and that any increase in the EDI of the individual resin acids and resin acid esters resulting from the proposed use of GETOR will not be of toxicological concern. Therefore, the agency concludes that the proposed use of GETOR is safe, that the additive will achieve the intended technical effect, and that § 172.735 should be amended as set forth in this document. To encompass the three glycerol ester of rosins (wood, gum, and tall oil) in the section heading for § 172.735, the petitioner has requested, and the agency concurs, that the section heading for § 172.735 should be changed from *Glycerol ester of wood or gum rosin* to *Glycerol ester of rosin* . FDA also considered the petitioner's request to include steam stripping as an alternative method to countercurrent steam distillation (presently listed in § 172.735) for purifying the rosin esters in § 172.735. Steam stripping is the method listed in the chewing gum base regulation (§ 172.615) for purifying GEWR, GEGR, and GETOR. As additional information, the petitioner provided the most recent specifications for GEWR adopted by the Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives (JEFCA, 46th session, 1996), which lists steam stripping, as well as countercurrent steam distillation as purification methods. FDA concludes that steam stripping is an acceptable method for purifying the rosin esters in § 172.735 and that this method, along with the specifications in the regulation, will ensure that the additive is of suitable purity for the intended use. Therefore § 172.735 is amended to include steam stripping as a purification method. III. Inspection of Documents In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT ). As provided in § 171.1(h), the agency will delete from the documents any material that is not available for public disclosure before making the documents available for inspection. IV. Environmental Impact The agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 6A4765 (71 FR 34623). No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required. V. Paperwork Reduction Act of 1995 This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VI. Objections Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES ) written or electronic objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 172 Food additives, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 172 is amended as follows: PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation for 21 CFR part 172 continues to read as follows: Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e. 2. Section 172.735 is amended by revising the section heading, introductory text, and paragraph
(a)to read as follows: § 172.735 Glycerol ester of rosin. Glycerol ester of wood rosin, gum rosin, or tall oil rosin may be safely used in food in accordance with the following prescribed conditions:
(a)It has an acid number of 3 to 9, a drop-softening point of 88 to 96 °C; and a color of N or paler as determined in accordance with Official Naval Stores Standards of the United States. It is purified by countercurrent steam distillation or steam stripping. Dated: August 15, 2007. Leslye M. Fraser, Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition. [FR Doc. E7-16558 Filed 8-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [CGD 008-07-017] RIN 1625-AA09 Drawbridge Operation Regulation; Ouachita River, LA AGENCY: Coast Guard, DHS. ACTION: Notice of deviation from drawbridge regulation. SUMMARY: The Commander, Eighth Coast Guard District has issued a temporary deviation from the regulation governing the operations of the U.S. 165 Bridge, Mile 110.1, Columbia, Louisiana across the Ouachita River. This deviation allows the bridge to remain closed-to-navigation from 8 a.m., August 6, 2007 until its removal from the waterway on August 31, 2007. The deviation is necessary in order to prepare the bridge for demolition. DATES: This temporary deviation is effective from 8 a.m., August 6, 2007 until August 31, 2007. ADDRESSES: Materials referred to in this document are available for inspection or copying at Room 2.107F in the Robert A. Young Federal Building, 1222 Spruce Street, St. Louis, MO 63103-2832, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays. The Bridge Administration Branch maintains the public docket for this temporary deviation. FOR FURTHER INFORMATION CONTACT: Roger K. Wiebusch, Bridge Administrator,
(314)269-2378. SUPPLEMENTARY INFORMATION: The Louisiana Department of Transportation requested a temporary deviation for the U.S. 165 Bridge, mile 110.1, at Columbia, Louisiana across the Ouachita River as preparation work is required on the bridge in advance of its scheduled demolition. The U.S. 165 Bridge currently operates in accordance with 33 CFR 117.483, which requires the drawbridge to open on signal if at least one hour notice is given. In order to facilitate the pre-demolition work, the drawbridge must be kept in the closed-to-navigation position. This deviation allows the drawbridge to remain closed-to-navigation from 8 a.m., August 6, 2007 until August 31, 2007. If the removal occurs prior to August 31, 2007, we will cancel this deviation via notice published in the local notice to mariners. There are no alternate routes for vessels transiting this section of the Ouachita River. The U.S. 165 Bridge, in the closed-to-navigation position, provides a vertical clearance of 50.2 feet above normal pool. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received. At the end of the designated time period, a Final Rule will be processed to remove this bridge from 33 CFR 117.483. Dated: August 1, 2007. Roger K. Wiebusch, Bridge Administrator. [FR Doc. E7-16493 Filed 8-21-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. CGD05-07-080] RIN 1625-AA87 Security Zone; M/V Odyssey III, Global Air Chiefs Conference, Upper Potomac River, Washington, DC AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a temporary security zone in certain waters of the Upper Potomac River surrounding the motor vessel Odyssey III, a 230-foot passenger vessel. This action is necessary in order to ensure the security of high-ranking public officials and safeguard the public at large against terrorist acts or incidents during activities associated with a dinner cruise held in conjunction with the Global Air Chiefs Conference, in Washington, DC, on September 23, 2007. This rule prohibits vessels and people from entering the security zone and requires vessels and persons in the security zone to depart the zone, unless specifically exempt under the provisions in this rule or granted specific permission from the Coast Guard Captain of the Port Baltimore, Maryland, or his designated representative. DATES: This rule is effective from 3 p.m. through 5 p.m. on September 23, 2007. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD05-07-080 and are available for inspection or copying at Coast Guard Sector Baltimore, Waterways Management Division, between 8 a.m. and 3 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Mr. Ronald Houck, at Coast Guard Sector Baltimore, Waterways Management Division, at telephone number
(410)576-2674 or
(410)576-2693. SUPPLEMENTARY INFORMATION: Regulatory Information We did not publish a notice of proposed rulemaking
(NPRM)for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. The Coast Guard is establishing this temporary security zone to coordinate security operations and establish a secure environment for this highly visible and publicized event. The publication of an NPRM is impracticable and contrary to the public interest as there is not sufficient time to publish an NPRM and get comments before issuing a final rule. Background and Purpose The ongoing hostilities in Afghanistan and Iraq have made it prudent for U.S. ports and waterways to be on a higher state of alert because the al Qaeda organization and other similar organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide. Due to increased awareness that future terrorist attacks are possible, the Coast Guard, as lead federal agency for maritime homeland security, has determined that the Captain of the Port Baltimore must have the means to be aware of, deter, detect, intercept, and respond to asymmetric threats, acts of aggression, and attacks by terrorists on the American homeland while still maintaining our freedoms and sustaining the flow of commerce. This security zone is part of a comprehensive port security regime designed to safeguard human life, vessels, and waterfront facilities against sabotage or terrorist attacks. In this particular rulemaking, to address the aforementioned security concerns before, during, and after the highly-publicized public event, and to take steps to prevent the catastrophic impact that a terrorist attack against high-ranking public officials and the public at large before, during, and after a dinner cruise held on the Upper Potomac River for visiting foreign dignitaries would have on the public interest, the Captain of the Port, Baltimore, Maryland is establishing a security zone upon waters of the Upper Potomac River, encompassing an area 100 yards in all directions around the passenger vessel Odyssey III while moored, underway or anchored on the Upper Potomac River. This security zone will help the Coast Guard to prevent vessels or persons from engaging in terrorist actions against a large number of participants during the event. Due to these heightened security concerns, and the catastrophic impact a terrorist attack on the passenger vessel Odyssey III would have on the large number of participants, and the surrounding area and communities, a security zone is prudent for this type of event. Discussion of Rule From September 20, 2007, through September 29, 2007, the U.S. Air Force Chief of Staff
(CSAF)will host the Global Air Chiefs Conference, in Washington, DC. In conjunction with this event, the CSAF has invited his counterparts from around the world to attend a dinner cruise on the Upper Potomac River on board the passenger vessel Odyssey III. The cruise will occur on Sunday, September 23, 2007. This security zone is necessary to prevent vessels or persons on waters of the Upper Potomac River, encompassing an area 100 yards in all directions around the passenger vessel Odyssey III while moored, underway or anchored, from approaching the vessel and thereby bypassing the security measures for the event established by the United States Air Force Office of Special Investigations. Vessel traffic in the Upper Potomac River will be restricted. Except for Public vessels and vessels at berth, mooring or at anchor, this rule requires all vessels in the designated security zone, as defined by this rule, underway at the time this security zone is implemented to immediately proceed out of the security zone. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designated representative. The Captain of the Port will issue Notices to Mariners to publicize the security zone and notify the public of changes in the status of the zone. Such notices will continue until the event has concluded. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. Although this rule prevents traffic from transiting a portion of the Upper Potomac River during the event, the effect of this rule will not be significant due to the limited size and duration of the security zone, the extensive notifications that will be made to the maritime community via marine information broadcasts, and vessel traffic not constrained by draft will be able to safely transit around the zone. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to operate, remain or anchor on the Upper Potomac River, encompassing an area 100 yards in all directions around the passenger vessel Odyssey III while moored, underway or anchored on the Upper Potomac River, from 3 p.m. to 5 p.m. on September 23, 2007. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for 2 hours, and vessels not constrained by draft, which usually are small entities, may safely transit around the zone. In addition, the Coast Guard will issue maritime advisories which will be widely available to users of the Upper Potomac River before the effective period. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation. This rule establishes a security zone. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES . List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add temporary § 165.T05-080 to read as follows: § 165.T05-080 Security Zone; M/V Odyssey III, Global Air Chiefs Conference, Upper Potomac River, Washington, DC.
(a)*Definitions.*
(1)For purposes of this section, *designated representative* means the Commander, Coast Guard Sector Baltimore, Maryland or any Coast Guard commissioned, warrant, or petty officer who has been authorized by the Captain of the Port, Baltimore, Maryland to act on his behalf.
(b)*Location.* The following area is a security zone: All waters of the Upper Potomac River, encompassing an area 100 yards in all directions around the motor vessel Odyssey III while moored, underway or anchored on the Upper Potomac River.
(c)*Regulations.*
(1)The general security zone regulations in 33 CFR part 165, subpart D, apply to the security zone described in paragraph
(a)of this section.
(2)Entry into or remaining in this zone is prohibited unless authorized by the Coast Guard Captain of the Port, Baltimore, Maryland, or his designated representative.
(3)Persons or vessels requiring entry into or passage through the security zone must first request authorization from the Captain of the Port, Baltimore, or his designated representative, for permission to transit the area. The Captain of the Port, Baltimore, Maryland can be contacted at telephone number
(410)576-2693. The Coast Guard vessels enforcing this section can be contacted on VHF Marine Band Radio, VHF channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port, Baltimore, Maryland, or his designated representative, and proceed at the minimum speed necessary to maintain a safe course while within the zone.
(4)The U.S. Coast Guard may be assisted in the patrol and enforcement of the zone by Federal, State, and local agencies.
(d)*Enforcement period.* This section will be enforced from 3 p.m. through 5 p.m. on September 23, 2007. Dated: August 7, 2007. Brian D. Kelley, Captain, U.S. Coast Guard, Captain of the Port, Baltimore, Maryland. [FR Doc. E7-16479 Filed 8-21-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF COMMERCE Patent and Trademark Office 37 CFR Parts 1 and 41 [Docket No. PTO-C-2006-0015] RIN 0651-AB81 Revision of Patent Fees for Fiscal Year 2007 AGENCY: United States Patent and Trademark Office, Commerce. ACTION: Final rule. SUMMARY: The United States Patent and Trademark Office (USPTO) (referred to as “Office” in this notice) is adjusting certain patent fee amounts to reflect fluctuations in the Consumer Price Index (CPI). Also, the Office is adjusting, by a corresponding amount, a few patent fee rates that track the affected fee amounts. The Director is authorized to adjust these fee amounts annually by the CPI to recover the higher costs associated with doing business. The USPTO is adjusting the patent fee amounts under the Consolidated Appropriations Act, 2005 (Consolidated Appropriations Act), which revised certain patent fee rates, and provided for a search fee and examination fee separate from the filing fee, during fiscal years 2005 and 2006; and continued in fiscal year 2007 under the revised Continuing Appropriations Resolution, 2007 (Continuing Appropriations Resolution). Legislation has been introduced that would extend the fee rate revisions in the Consolidated Appropriations Act. In the event legislation is not enacted to continue the patent fee amounts under the Consolidated Appropriations Act, the USPTO will be adjusting patent statutory fee rates that were in application prior to implementation of the Consolidated Appropriations Act. The prior fee rates, adjusted for CPI, will be effective for fiscal year 2008. DATES: Effective September 30, 2007. FOR FURTHER INFORMATION CONTACT: Dianne Woods by e-mail at *Dianne.Woods@uspto.gov* , by telephone at
(571)272-6301, or by fax at
(571)273-0127. SUPPLEMENTARY INFORMATION: This final rule adjusts certain USPTO patent fee amounts in accordance with the applicable provisions of title 35, United States Code, as amended by the Consolidated Appropriations Act (Pub. L. 108-447). This final rule also adjusts, by a corresponding amount, a few patent fee rates (37 CFR 1.17(e),
(r)and
(s)that track statutory fee amounts (37 CFR 1.16(a)). The USPTO is adjusting the patent fee amounts established under the Consolidated Appropriations Act, and extended under the revised Continuing Appropriations Resolution. Legislation has been introduced in the Congress that would extend the fee amount revisions in the Consolidated Appropriations Act, and the revised Continuing Appropriations Resolution. If the legislation is enacted, then this final rule will apply. If this legislation is not enacted, then the fee rate adjustments will apply to the former fee amounts in place on October 1, 2004, to December 7, 2004 (prior to the enactment of the Consolidated Appropriations Act). A proposed rule notice was published at 71 FR 32285 on June 5, 2006, which requested comments by July 5, 2006. No comments were received. An incorrect reference to National stage fees was corrected. The USPTO delayed implementation of the CPI fee rates adjustment from October 1, 2006, to September 30, 2007. During this time, the Administration's projected CPI-U for the twelve-month period prior to enactment of the fee rates adjustment decreased from 3.5 percent to 2.8 percent. Based on the revised projected CPI-U, patent statutory fee amounts will be adjusted by 2.8 percent in this final rule. Customers may wish to refer to the USPTO's official Web site at *http://www.uspto.gov* for the most current fee amounts. Background Statutory Provisions Patent fee amounts are authorized by 35 U.S.C. 41, 119, 120, 132(b) and 376. For fees paid under 35 U.S.C. 41(a) and
(b)and 132(b), independent inventors, small business concerns, and nonprofit organizations who meet the requirements of 35 U.S.C. 41(h)(1) are entitled to a fifty-percent reduction. Section 41(f) of title 35, United States Code, provides that fee amounts established under 35 U.S.C. 41(a) and
(b)may be adjusted on October 1, 1992, and every year thereafter, to reflect fluctuations in the CPI over the previous twelve months. Section 41(d) of title 35, United States Code, authorizes the Director to establish fee amounts for all other processing, services, or materials related to patents to recover the average cost of providing these services or materials, except for the fees for recording a document affecting title, for each photocopy, for each black and white copy of a patent, and for standard library service. Section 41(g) of title 35, United States Code, provides that new fee amounts established by the Director under section 41 may take effect thirty days after notice in the **Federal Register** and the *Official Gazette of the United States Patent and Trademark Office.* Fee Adjustment Level The patent statutory fee amounts established by 35 U.S.C. 41(a) and
(b)will be adjusted on September 30, 2007, to reflect fluctuations occurring during the twelve-month period from October 1, 2006, through September 30, 2007, in the Consumer Price Index for All Urban Consumers (CPI-U). The Office of Management and Budget has advised that in calculating these fluctuations, the USPTO should use CPI-U data as determined by the Secretary of Labor. In accordance with previous fee-setting methodology, the Office bases this fee rate adjustment on the Administration's projected CPI-U for the twelve-month period ending September 30, 2007, which is 2.8 percent. Based on this projected CPI-U, patent statutory fee amounts will be adjusted by 2.8 percent. Certain patent processing fee rates established under 35 U.S.C. 41(d), 119, 120, 132(b), 376, and Public Law 103-465 (the Uruguay Round Agreements Act) will be adjusted to reflect fluctuations in the CPI. The fee amounts were rounded by applying standard arithmetic rules so that the amounts rounded will be convenient to the user. Fee rates for other than a small entity of $100 or more were rounded to the nearest $10. Fee rates of less than $100 were rounded to an even number so that any comparable small entity fee amount will be a whole number. Discussion of Specific Rules Legislation has been introduced in the Congress that would extend the fee revisions in the Consolidated Appropriations Act, and the revised Continuing Appropriations Resolution. If the legislation is enacted, then this final rule will apply. To ensure clarity in the implementation of the proposed new fee amounts, a discussion of specific revisions is set forth below. 37 CFR 1.16 National Application Filing, Search, and Examination Fees Section 1.16, paragraphs
(a)through (e), and
(h)through (s), are revised to adjust fee rates established therein to reflect fluctuations in the CPI. 37 CFR 1.17 Patent Application and Reexamination Processing Fees Section 1.17, paragraphs (a)(2) through (a)(5), (e), (l), (m), and
(r)through (t), are revised to adjust fee rates established therein to reflect fluctuations in the CPI. 37 CFR 1.18 Patent Post Allowance (Including Issue) Fees Section 1.18, paragraphs
(a)through (c), are revised to adjust fee rates established therein to reflect fluctuations in the CPI. 37 CFR 1.20 Post Issuance Fees Section 1.20, paragraphs (c)(3), (c)(4), and
(e)through (g), are revised to adjust fees established therein to reflect fluctuations in the CPI. 37 CFR 1.492 National Stage Fees Section 1.492, paragraphs (a), (b)(2) through (b)(4), (c)(2),
(d)through (f), and (j), are revised to adjust fees established therein to reflect fluctuations in the CPI. 37 CFR 41.20 Fees Section 41.20, paragraphs (b)(1) through (b)(3), are revised to adjust fees established therein to reflect fluctuations in the CPI. Other Considerations *Paperwork Reduction Act:* This final rule involves information collection requirements that are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 *et seq.* The collections of information involved in this final rule have been reviewed and previously approved by the OMB under the following control numbers: 0651-0016, 0651-0021, 0651-0031, 0651-0032, and 0651-0033. The USPTO is not resubmitting information collection requests to the OMB for its review and approval because the changes in this final rule do not affect the information collection requirements associated with the information collections under these OMB control numbers. Notwithstanding any other provisions of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number. This final rule has been determined to be not significant for purposes of Executive Order 12866. This final rule does not contain policies with Federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (August 4, 1999). *Regulatory Flexibility Act:* For the reasons set forth herein, The Deputy General Counsel for General Law of the USPTO has certified to the Chief Counsel for Advocacy, Small Business Administration, that the final rule change will not have a significant economic impact on a substantial number of small entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)). By statute, the USPTO's Director is expressly authorized to adjust fee amounts annually to reflect fluctuations in the CPI. *See* 35 U.S.C. 41(f) (certain fees “may be adjusted by the Director on October 1, 1992, and every year thereafter, to reflect any fluctuations occurring during the previous 12 months in the Consumer Price Index as determined by the Secretary of Labor”). This final rule increases fee amounts to reflect the change in the CPI as authorized by 35 U.S.C. 41(f). Legislation has been introduced in the Congress that would extend the fee amount revisions in the Consolidated Appropriations Act and the revised Continuing Appropriations Resolution. If the legislation is enacted, then this final rule will apply. The fee amount increases will range from a minimum of $0 to a maximum of $110 under the final rule. Under 35 U.S.C. 41(h)(1) small entities are accorded a fifty-percent reduction in most patent fee amounts. Consequently, the small entity fee increases will range from a minimum of $0 to a maximum of $55 under the final rule. The sole exception under this final rule is the fee set forth under 37 CFR 1.17(t), which does not qualify for a small entity fee reduction. The fee rate increase for 37 CFR 1.17(t) is $40. Accordingly, the final rule does not have a significant economic impact on a substantial number of small entities. Lists of Subjects 37 CFR Part 1 Administrative practice and procedure, Biologics, Courts, Freedom of information, Inventions and patents, Reporting and recordkeeping requirements, Small businesses. 37 CFR Part 41 Administrative practice and procedure, Inventions and patents, Lawyers. For the reasons set forth in the preamble, the USPTO is proposing to amend title 37 of the Code of Federal Regulations, parts 1 and 41, as set forth below. PART 1—RULES OF PRACTICE IN PATENT CASES 1. The authority citation for 37 CFR part 1 would continue to read as follows: Authority: 35 U.S.C. 2(b)(2), unless otherwise noted. 2. Section 1.16 is amended by revising paragraphs
(a)through (e), and
(h)through
(s)to read as follows: § 1.16 National application filing, search and examination fees.
(a)Basic fee for filing each application under 35 U.S.C. 111 for an original patent, except design, plant, or provisional applications:
(1)For an application filed on or after December 8, 2004: By a small entity (§ 1.27(a)) if the application is submitted in compliance with the Office electronic filing system (§ 1.27(b)(2)) $75.00 By a small entity (§ 1.27(a)) $155.00 By other than a small entity $310.00
(2)For an application filed before December 8, 2004: By a small entity (§ 1.27(a)) $405.00 By other than a small entity $810.00
(b)Basic fee for filing each application for an original design patent:
(1)For an application filed on or after December 8, 2004: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(2)For an application filed before December 8, 2004: By a small entity (§ 1.27(a)) $180.00 By other than a small entity $360.00
(c)Basic fee for filing each application for an original plant patent:
(1)For an application filed on or after December 8, 2004: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(2)For an application filed before December 8, 2004: By a small entity (§ 1.27(a)) $285.00 By other than a small entity $570.00
(d)Basic fee for filing each provisional application: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(e)Basic fee for filing each application for the reissue of a patent:
(1)For an application filed on or after December 8, 2004: By a small entity (§ 1.27(a)) $155.00 By other than a small entity $310.00
(2)For an application filed before December 8, 2004: By a small entity (§ 1.27(a)) $405.00 By other than a small entity $810.00
(h)In addition to the basic filing fee in an application, other than a provisional application, for filing or later presentation at any other time of each claim in independent form in excess of 3: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(i)In addition to the basic filing fee in an application, other than a provisional application, for filing or later presentation at any other time of each claim (whether dependent or independent) in excess of 20 (note that § 1.75(c) indicates how multiple dependent claims are considered for fee calculation purposes): By a small entity (§ 1.27(a)) $25.00 By other than a small entity $50.00
(j)In addition to the basic filing fee in an application, other than a provisional application, that contains, or is amended to contain, a multiple dependent claim, per application: By a small entity (§ 1.27(a)) $185.00 By other than a small entity $370.00
(k)Search fee for each application filed under 35 U.S.C. 111 on or after December 8, 2004, for an original patent, except design, plant, or provisional applications: By a small entity (§ 1.27(a)) $255.00 By other than a small entity $510.00
(l)Search fee for each application filed on or after December 8, 2004, for an original design patent: By a small entity (§ 1.27(a)) $50.00 By other than a small entity $100.00
(m)Search fee for each application filed on or after December 8, 2004, for an original plant patent: By a small entity (§ 1.27(a)) $155.00 By other than a small entity $310.00
(n)Search fee for each application filed on or after December 8, 2004, for the reissue of a patent: By a small entity (§ 1.27(a)) $255.00 By other than a small entity $510.00
(o)Examination fee for each application filed under 35 U.S.C. 111 on or after December 8, 2004, for an original patent, except design, plant, or provisional applications: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(p)Examination fee for each application filed on or after December 8, 2004, for an original design patent: By a small entity (§ 1.27(a)) $65.00 By other than a small entity $130.00
(q)Examination fee for each application filed on or after December 8, 2004, for an original plant patent: By a small entity (§ 1.27(a)) $80.00 By other than a small entity $160.00
(r)Examination fee for each application filed on or after December 8, 2004, for the reissue of a patent: By a small entity (§ 1.27(a)) $310.00 By other than a small entity $620.00
(s)Application size fee for any application under 35 U.S.C. 111 filed on or after December 8, 2004, the specification and drawings of which exceed 100 sheets of paper, for each additional 50 sheets or fraction thereof (see § 1.52(f) for applications submitted in whole or in part on an electronic medium): By a small entity (§ 1.27(a)) $130.00 By other than a small entity $260.00 3. Section 1.17 is amended by revising paragraphs (a)(2) through (a)(5), (e), (l), (m), and
(r)through
(t)to read as follows: § 1.17 Patent application and reexamination processing fees.
(a)* * *
(2)For reply within second month: By a small entity (§ 1.27(a)) $230.00 By other than a small entity $460.00
(3)For reply within third month: By a small entity (§ 1.27(a)) $525.00 By other than a small entity $1,050.00
(4)For reply within fourth month: By a small entity (§ 1.27(a)) $815.00 By other than a small entity $1,630.00
(5)For reply within fifth month: By a small entity (§ 1.27(a)) $1,110.00 By other than a small entity $2,220.00
(e)To request continued examination pursuant to § 1.114: By a small entity (§ 1.27(a)) $405.00 By other than a small entity $810.00
(l)For filing a petition for the revival of an unavoidably abandoned application under 35 U.S.C. 111, 133, 364, or 371, for the unavoidably delayed payment of the issue fee under 35 U.S.C. 151, or for the revival of an unavoidably terminated reexamination proceeding under 35 U.S.C. 133 (§ 1.137(a)): By a small entity (§ 1.27(a)) $255.00 By other than a small entity $510.00
(m)For filing a petition for the revival of an unintentionally abandoned application, for the unintentionally delayed payment of the fee for issuing a patent, or for the revival of an unintentionally terminated reexamination proceeding under 35 U.S.C. 41(a)(7) (§ 1.137(b)): By a small entity (§ 1.27(a)) $770.00 By other than a small entity $1,540.00
(r)For entry of a submission after final rejection under § 1.129(a): By a small entity (§ 1.27(a)) $405.00 By other than a small entity $810.00
(s)For each additional invention requested to be examined under § 1.129(b): By a small entity (§ 1.27(a)) $405.00 By other than a small entity $810.00
(t)For the acceptance of an unintentionally delayed claim for priority under 35 U.S.C. 119, 120, 121, or 365(a) or (c): (§§ 1.55 and 1.78) $1,410.0 4. Section 1.18 is amended by revising paragraphs
(a)through
(c)to read as follows: § 1.18 Patent post allowance (including issue) fees.
(a)Issue fee for issuing each original patent, except a design or plant patent, or for issuing each reissue patent: By a small entity (§ 1.27(a)) $720.00 By other than a small entity $1,440.00
(b)Issue fee for issuing an original design patent: By a small entity (§ 1.27(a)) $410.00 By other than a small entity $820.00
(c)Issue fee for issuing an original plant patent: By a small entity (§ 1.27(a)) $565.00 By other than a small entity $1,130.00 5. Section 1.20 is amended by revising paragraphs (c)(3), (c)(4), and
(e)through
(g)to read as follows: § 1.20 Post issuance fees.
(c)* * *
(3)For filing with a request for reexamination or later presentation at any other time of each claim in independent form in excess of 3 and also in excess of the number of claims in independent form in the patent under reexamination: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(4)For filing with a request for reexamination or later presentation at any other time of each claim (whether dependent or independent) in excess of 20 and also in excess of the number of claims in the patent under reexamination (note that § 1.75(c) indicates how multiple dependent claims are considered for fee calculation purposes): By a small entity (§ 1.27(a)) $25.00 By other than a small entity $50.00
(e)For maintaining an original or reissue patent, except a design or plant patent, based on an application filed on or after December 12, 1980, in force beyond four years, the fee being due by three years and six months after the original grant: By a small entity (§ 1.27(a)) $465.00 By other than a small entity $930.00
(f)For maintaining an original or reissue patent, except a design or plant patent, based on an application filed on or after December 12, 1980, in force beyond eight years, the fee being due by seven years and six months after the original grant: By a small entity (§ 1.27(a)) $1,180.00 By other than a small entity $2,360.00
(g)For maintaining an original or reissue patent, except a design or plant patent, based on an application filed on or after December 12, 1980, in force beyond twelve years, the fee being due by eleven years and six months after the original grant: By a small entity (§ 1.27(a)) $1,955.00 By other than a small entity $3,910.00 6. Section 1.492 is amended by revising paragraphs (a), (b)(2) through (b)(4), (c)(2),
(d)through (f), and
(j)to read as follows: § 1.492 National stage fees.
(a)The basic national fee for an international application entering the national stage under 35 U.S.C. 371 if the basic national fee was not paid before December 8, 2004: By a small entity (§ 1.27(a)) $155.00 By other than a small entity $310.00
(b)* * *
(2)Where a search report on the international application has been prepared by the USPTO: By a small entity (§ 1.27(a)) $50.00 By other than a small entity $100.00
(3)Where a search report on the international application has been prepared and provided to the USPTO: By a small entity (§ 1.27(a)) $205.00 By other than a small entity $410.00
(4)In all situations not provided for in paragraph (b)(1) through
(3)of this section: By a small entity (§ 1.27(a)) $255.00 By other than a small entity $510.00
(c)* * *
(2)In all situations not provided for in paragraph (c)(1) of this section: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(d)In addition to the basic national fee, for filing or on a later presentation at any other time of each claim in independent form in excess of 3: By a small entity (§ 1.27(a)) $105.00 By other than a small entity $210.00
(e)In addition to the basic national fee, for filing or on later presentation at any other time of each claim (whether dependent or independent) in excess of 20 (note that § 1.75(c) indicates how multiple dependent claims are considered for fee calculation purposes): By a small entity (§ 1.27(a)) $25.00 By other than a small entity $50.00
(f)In addition to the basic national fee, if the application contains, or is amended to contain, a multiple dependent claim, per application: By a small entity (§ 1.27(a)) $185.00 By other than a small entity $370.00
(j)Application size fee for any international application for which the basic national fee was not paid before December 8, 2004, the specification and drawings of which exceed 100 sheets of paper, for each additional 50 sheets or fraction thereof (see § 1.52(f) for applications submitted in whole or in part on an electronic medium): By a small entity (§ 1.27(a)) $130.00 By other than a small entity $260.00 PART 41—PRACTICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES 1. The authority citation for 37 CFR part 41 would continue to read as follows: Authority: 35 U.S.C. 2(b)(2), 3(a)(2)(A), 21, 23, 32, 41, 134, 135, unless otherwise noted. 2. Section 41.20 is amended by revising paragraphs (b)(1) through (b)(3) to read as follows: § 41.20 Fees.
(b)* * *
(1)For filing a notice of appeal from the examiner to the Board: By a small entity (§ 1.27(a) of this title) $255.00 By other than a small entity $510.00
(2)In addition to the fee for filing a notice of appeal, for filing a brief in support of an appeal: By a small entity (§ 1.27(a) of this title) $255.00 By other than a small entity $510.00
(3)For filing a request for an oral hearing before the Board in an appeal under 35 U.S.C. 134: By a small entity (§ 1.27(a) of this title) $515.00 By other than a small entity $1,030.00 Dated: August 1, 2007. Jon W. Dudas, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. E7-16574 Filed 8-21-07; 8:45 am] BILLING CODE 3510-16-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2004-SC-0004-200706 (a); FRL-8457-2] Approval and Promulgation of Implementation Plans South Carolina: Revisions to Ambient Air Quality Standards AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving revisions to the State Implementation Plan
(SIP)submitted by the South Carolina Department of Health and Environmental Control (SC DHEC) on November 19, 2004, for the purpose of incorporating EPA's July 18, 1997, revisions to the National Ambient Air Quality Standards and to ensure consistency between state and Federal regulations. The revisions consist of the amendments published in the South Carolina State Register on September 24, 2004, revising Regulation 61-62.5, Standard Number 2, Ambient Air Quality Standards. DATES: This direct final rule is effective October 22, 2007 without further notice, unless EPA receives adverse comment by September 21, 2007. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** and inform the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-OAR-2004-SC-200706, by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail: ward.nacosta@epa.gov* . 3. *Fax:* 404-562-9019. 4. *Mail:* “EPA-R04-OAR-2004-SC-0004”, 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. 5. *Hand Delivery or Courier:* Deliver your comments to: Nacosta C. Ward, 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 a.m. to 4:30 p.m., excluding federal holidays. *Instructions:* Direct your comments to Docket ID No. EPA-R04-OAR-2004-SC-0004. 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 *http://www.regulations.gov* or e-mail, information that you consider to be CBI or otherwise protected. The *http://www.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 *http://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 *http://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 *http://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 a.m. to 4:30 p.m., excluding federal holidays. FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, 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. The telephone number is
(404)562-9140. Ms. Ward can also be reached via electronic mail at *ward.nacosta@epa.gov* . SUPPLEMENTARY INFORMATION: I. Analysis of State's Submittal On November 19, 2004, SC DHEC submitted revisions to the South Carolina SIP. These revisions were published in the South Carolina State Register on September 24, 2004, revising Regulation 61-62.5, Standard Number 2, Ambient Air Quality Standards. The changes to the South Carolina SIP incorporate Federal revisions to the ozone and particulate matter standards and add applicable appendices from the Code of Federal Regulations
(CFR)referencing the Reference Methods. The analytical methods to be used in Regulation 61-62.5, Standard 2, will be those applicable Reference Methods, located in 40 CFR 50, Appendices A through H and K with the addition of Appendices I through N, as revised on July 18, 1997. Appendices I and N have been added in footnote
(3)following the table, which reference the two revisions to the table regarding 8-hour ozone and PM 2.5 . The appendices located in 40 CFR 50 are those that attainment determinations are based upon. The 8-hour ozone and PM 2.5 (primary and secondary) standards have been added to South Carolina's ambient air quality standards table. The portion of the table containing these additions is reflected below: Pollutant Measuring interval Micrograms per cubic meter PM 2.5 (Primary and Secondary Standards) 24 hours Annual 65
(3)15
(3)Ozone 8 hours 0.08 ppm
(3)Attainment determinations will be made based on the criteria contained in 40 CFR 50 Appendices H, I, K, and N. II. Final Action EPA is approving the aforementioned changes to the South Carolina SIP because they are consistent with the Clean Air Act and EPA policy. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this **Federal Register** publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective October 22, 2007 without further notice unless the Agency receives adverse comments by September 21, 2007. If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on October 22, 2007 and no further action will be taken on the proposed rule. III. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 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 action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves 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 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 approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This 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. In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. 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 Clean Air Act. 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 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.* ). The Congressional Review Act, 5 U.S.C. section 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. section 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 22, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: July 31, 2007. J.I. Palmer, Jr., Regional Administrator, Region 4. Chapter I, title 40, *Code of Federal Regulations,* is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart PP—South Carolina 2. Section 52.2120(c) is amended under Regulation No. 62.5, by revising the entry for “Standard No. 2” to read as follows: § 52.2120 Identification of plan.
(c)* * * Air Pollution Control Regulations for South Carolina State citation Title/subject State effective date EPA approval date Federal Register notice * * * * * * * Regulation No. 62.5 Air Pollution Control Standards * * * * * * * Standard No. 2 Ambient Air Quality Standards 09/24/04 08/22/07 [Insert citation of publication]. * * * * * * * [FR Doc. E7-16316 Filed 8-21-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0821; FRL-8140-9] Buprofezin; Pesticide Tolerance; Technical Amendment AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule; technical amendment. SUMMARY: EPA issued a final rule in the **Federal Register** of June 27, 2007, concerning the establishment of tolerances for residues of buprofezin on various commodities. This document is being issued to correct a typographical omission. DATES: This final rule is effective August 22, 2007. ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0821. 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: 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? The Agency included in the final rule a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under the FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document and Other Related Information? In addition to using regulations.gov, you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . II. What Does this Correction Do? FR Doc. E7-12161 published in the **Federal Register** of June 27, 2007 (72 FR 35182) (FRL-8133-1) is corrected as follows: On page 35187, 180.511(a), the table in the amendment to § 180.511(a) establishing tolerances appeared as a two column table. The table should have appeared as a three column table. The omitted third column should include the heading “Expiration/Revocation Date”, and the entry “None” to correspond to the tolerance listed in each row. This document is being published to correct that omission. III. Why is this Correction Issued as a Final Rule? Section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), provides that, when an Agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the Agency may issue a final rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making this technical amendment final without prior proposal and opportunity for comment, because the use of notice and comment procedures is unnecessary to effectuate this correction. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B). IV. Do Any of the Statutory and Executive Order Reviews Apply to this Action? No. This action only corrects typographical omissions for a previously published final rule and does not impose any new requirements. EPA's compliance with the statutes and Executive Orders for the underlying rule is discussed in Unit VI. of the June 27, 2007 final rule (71 FR 35182). V. 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 3, 2007. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180--[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.511 is amended in paragraph
(a)in the table as follows: i. By alphabetically adding “Apricot” and “Fruit, stone, group 12, except apricot and peach”; and ii. By revising the entries for “Canistel,” “Grape,” “Mango,” “Papaya,” “Sapodilla,” “Sapote, black,” “Sapote, mamey,” and “Star apple.” The amendments read as follows: § 180.511 Buprofezin; tolerances for residues.
(a)* * * Commodity Parts per million Expiration/Revocation Date * * * * * Apricot 9.0 None * * * * * Canistel 0.90 None * * * * * Fruit, stone, group 12, except apricot and peach 1.9 None * * * * * Grape 2.5 None * * * * * Mango 0.90 None * * * * * Papaya 0.90 None * * * * * Sapodilla 0.90 None Sapote, black 0.90 None Sapote, mamey 0.90 None * * * * * Star apple 0.90 None * * * * * [FR Doc. E7-16604 Filed 8-21-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0206; FRL-8142-6] Fipronil; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for combined residues of fipronil and its two metabolites and one photodegradate in or on potato and potato, wet peel, and indirect or inadvertent residues of fipronil and its two metabolites and one photodegradate in or on wheat, forage; wheat, grain; wheat, hay; and wheat, straw. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, this establishes time-limited tolerances for combined residues of fipronil in or on turnip and rutabaga. 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 turnip and rutabaga. This regulation establishes maximum permissible levels for combined residues of fipronil in these food commodities. The tolerances for rutabaga and turnip expire and are revoked on December 31, 2010. DATES: This regulation is effective August 22, 2007. Objections and requests for hearings must be received on or before October 22, 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-2005-0206. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-6502; e-mail address: *sibold.ann@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0206 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 22, 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-2005-0206, 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 Tolerances In the **Federal Register** of August 24, 2005 (70 FR 49599) (FRL-7726-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F6948) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.517 be amended by establishing tolerances for combined residues of the insecticide fipronil, 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2 metabolites, MB45950 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4- [(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile), and photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-carbonitrile), in or on vegetable, tuberous , corm, subgroup 1C at 0.04 parts per million
(ppm)and potato, wet peel at 0.4 ppm and indirect or inadvertent residues of the insecticide fipronil, 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2 metabolites MB45950 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-carbonitrile), in or on wheat, forage at 0.04 ppm, wheat, grain at 0.04 ppm, wheat, hay at 0.04 ppm, and wheat, straw at 0.04 ppm. That notice referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has revised the tolerance for vegetable tuberous corm crop subgroup 1C to limit it to potato. The reason for these changes is explained in Unit V. EPA is also establishing time-limited tolerances for combined residues of the insecticide fipronil, in or on turnip and rutabaga at 1.0 ppm. These tolerances expire and are revoked on December 31, 2010. The tolerances are being established in response to EPA’s authorization to the Oregon Department of Agriculture, for the emergency use of fipronil to control the cabbage maggot, a highly damaging pest to root crops, in these crops, under a FIFRA section 18 specific exemption. The request was based upon three factors: 1. A recent severe increase in cabbage maggot populations. 2. The apparent increasing resistance of the maggot to the organophosphate registered alternative. 3. Phytotoxicity of the organophosphate alternative to the emerging seedlings. The Applicant stated that significant economic losses would occur without the requested use of fipronil under an emergency exemption. After having reviewed the submission, EPA concurs that emergency conditions exist for this State. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of fipronil in or on rutabaga and turnip. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerances under section 408(l)(6) of 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 the tolerances expire and are revoked on December 31, 2010, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on rutabaga and turnip 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 the rutabaga and turnip tolerances are being approved under emergency conditions, EPA has not made any decisions about whether fipronil meets EPA's registration requirements for use on rutabaga and turnip or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of fipronil by a State for special local needs under FIFRA section 24(c). Nor do these tolerances serve as the basis for any State other than Oregon to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemptions for fipronil, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT . III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for combined residues of fipronil and its metabolites and its degradate on potato at 0.03 ppm and potato, wet peel at 0.10 ppm and indirect or inadvertent residues of fipronil and its metabolites and its degradate on wheat, forage at 0.02 ppm, wheat, grain at 0.005 ppm, wheat, hay at 0.03 ppm, and wheat, straw at 0.03 ppm, and the tolerances to support authorization of an emergency exemption on turnip at 1.0 ppm and rutabaga at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by fipronil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The referenced document, “Fipronil: Third Reevaluation—Report of the Hazard Identification Assessment Review Committee, December 6, 2000,” is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2005-0206 in that docket. 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-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable uncertainty/safety factors is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for fipronil used for human risk assessment is shown in Table 1 of this unit. **Table 1.—Summary of Toxicological Dose and Endpoints for Fipronil for Use in Human Risk Assessment** Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute dietary (All populations including infants and children) NOAEL= 2.5 milligrams/kilograms (mg/kg) UF = 100 acute RfD = 0.025 mg/kg FQPA SF = 1 aPAD = acute RfD÷FQPA SF = 0.025 mg/kg Acute neurotoxicity—rat LOAEL = 7.0 mg/kg based on: Decreased hind leg splay in males at 7 hours Chronic dietary (All populations) NOAEL= 0.019 mg/kg/day UF = 100 chronic RfD = 0.0002 mg/kg/day FQPA SF = 1 cPAD = chr RfD÷FQPA SF = 0.0002 mg/kg/day Chronic/carcinogenicity study —rat LOAEL = 0.059 mg/kg/day based on: Increased incidence of seizures and death, alterations in clinical chemistry (protein), increased thyroid stimulating hormone (TSH), and decreased T4 Short-term oral (1-7 days) (Residential) Oral study maternal LOAEL < 0.1 mg/kg/day UF of 3 for no NOAEL, 100 for interspecies extrapolation and intraspecies variation LOC for MOE = 300 (Residential, includes the FQPA SF) Developmental toxicity study—rabbit maternal LOAEL = 0.1 mg/kg/day based on: Maternal toxicity of decreased body weight gain, decreased food consumption, and decreased food efficiency Intermediate-term oral (1 week—several months) (Residential) Oral study LOAEL < 0.1 mg/kg/day UF of 3 for no NOAEL, 100 for interspecies extrapolation and intraspecies variation LOC for MOE = 300 (Residential, includes the FQPA SF) Developmental toxicity study—rabbit LOAEL = 0.1 mg/kg/day based on: Maternal toxicity of decreased body weight gain, decreased food consumption, and decreased food efficiency Short-termdermal (1-7 days) (Residential) Dermal study NOAEL= 5 mg/kg/day LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes FQPA SF) 21-Day dermal toxicity study—rabbit LOAEL = 10.0 mg/kg/day based on: Decreased body weight gain, and food consumption in both sexes Intermediate-term dermal (1 week—several months) (Residential) Dermal study NOAEL = 5 mg/kg/day LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes FQPA SF) 21-Day dermal toxicity study— rabbit LOAEL = 10.0 mg/kg/day based on: Decreased body weight gain, and food consumption in both sexes Long-term dermal (several months—lifetime) (Residential) Oral study NOAEL = 0.019 mg/kg/day(dermal absorption rate = 1%) acceptable MOE = 100 (Occupational) acceptable MOE = 100 (Residential, includes FQPA SF) Chronic/carcinogenicity study —rat LOAEL = 0.059 mg/kg/day based on: Increased incidence of seizures and death, alterations in clinical chemistry (protein), increased TSH, and decreased T4 Short-term inhalation (1-7 days) (Residential) Oral study NOAEL = 0.05 mg/kg/day(inhalation absorption rate = 100%) LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes FQPA SF) Developmental neurotoxicity— rat LOAEL = 0.90 mg/kg/day based on: Decrease in group mean pup weights during lactation, and significant increase in time of preputial separation in males (dietary) Intermediate-term inhalation (1 week—several months) (Residential) Oral study NOAEL = 0.05 mg/kg/day (inhalation absorption rate = 100%) LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential, includes FQPA SF) Developmental neurotoxicity— rat LOAEL = 0.90 mg/kg/day based on: Decrease in group mean pup weights during lactation, and significant increase in time of preputial separation in males (dietary) Long-term inhalation (several months—lifetime) (Residential) O ral study NOAEL= 0.019 mg/kg/day (inhalation absorption rate = 100%) acceptable MOE = 100 (Occupational) acceptable MOE = 100 (Residential, includes FQPA SF) Chronic/carcinogenicity rat study LOAEL = 0.059 mg/kg/day based on: Increased incidence of seizures and death, alterations in clinical chemistry (protein), increased TSH, and decreased T4 Cancer (Oral, dermal, inhalation) Group C—possible human carcinogen Use chronic RfD to estimate human risk Increases in thyroid follicular cell tumors with fipronil (male/female) UF = uncertainty factor, FQPA SF = 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, LOC = level of concern, MOE = margin of exposure. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to fipronil, EPA considered exposure under the petitioned-for tolerances, as well as the turnip and rutabaga tolerances to support the authorized section 18s, and all existing fipronil tolerances in (40 CFR 180.517). EPA assessed dietary exposures from fipronil in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture
(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed all foods for which there are tolerances were treated and contain tolerance-level residues. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Nationwide CSFII. As to residue levels in food, EPA relied upon anticipated residues and percent crop treated information for some commodities A partially refined analysis was performed using anticipated residues from field trial data for existing uses for which data were available. Anticipated residues were also used for potato commodities. Processing factors were used for existing uses. Percent crop treated was not used. iii. *Cancer* . Fipronil has been classified as a Group C—Possible Human Carcinogen, based on increases in thyroid follicular cell tumors in both sexes of the rat, which were statistically significant by both pair-wise and trend analyses. There is no apparent concern for mutagenicity (no mutagenic activity). The RfD methodology should be used to estimate human risk for the following reasons: The thyroid tumors appear to be related to a disruption in the thyroid-pituitary status, and fipronil is not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis. In addition, the cRfD is based on the NOAEL from the combined chronic/carcinogenicity study in rats. The NOAEL is based on increased incidence of seizures and death, alterations in clinical chemistry (protein) and thyroid toxicity (increase in TSH), decrease in thyroxine (T4)). Therefore, the cRfD is considered to be protective of both cancer and non-cancer effects of fipronil. iv. *Anticipated residue and percent crop treated
(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances. 2. *Dietary exposure from drinking water* .The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for fipronil in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of fipronil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations
(EECs)of fipronil for acute exposures are estimated to be 2.654 parts per billion
(ppb)for surface water and 0.021 ppb for ground water. The EECs for chronic exposures are estimated to be 0.3179 ppb for surface water and 0.021 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 2.654 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 0.3179 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fipronil is currently registered for the following residential non-dietary sites: For use on cats and dogs for flea control and on turf to control fire ants. These products may be applied by homeowners. EPA assessed residential exposure using the following assumptions: The probability of applying fipronil to dogs and cats to control fleas and ticks and applying fipronil to control turf pests on the same day is considered to be negligible for the following reasons: Use on turf application is limited to application one per year. For the pet care products, fipronil is applied as a Ready-to-Use
(RTU)pump spray to the fur of the animal or as a RTU, pour-on, spot treatment made on the back of the animal between the shoulder blades. Repeated applications if necessary may be made once every one to three months during flea or tick season. Therefore, since these applications are infrequent, for aggregate risk assessment, exposure from pet and turf treatments were not combined. Based on the existing and proposed uses, the pet uses result in the highest estimated handler exposure. Since more exposure is expected from the pet care spray product, exposure to the spray product represents the worst case for all residential scenarios. For post-application risk, the use on pets is used to estimate exposure to toddlers. Adult post-application exposure is considered negligible. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fipronil and any other substances and fipronil does not appear to produce a toxic metabolite produced by other substances. For the purposes of these tolerance actions, therefore, EPA has not assumed that fipronil 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* . 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* . EPA concluded that there is no indication of increased susceptibility of rats or rabbits to *in utero* and/or postnatal exposure to fipronil. In the prenatal developmental toxicity studies in rats and rabbits and in the 2-generation reproduction study in rats, developmental toxicity occurred at the same or greater doses than those that caused maternal toxicity. In particular, the toxicity endpoint used for the short term oral exposure scenario was based on maternal effects seen in the developmental toxicity study. However, because no maternal NOAEL was established, an additional 3X safety factor was added to the maternal LOAEL. The developmental or offspring NOAEL was 10x greater than the maternal LOAEL. In addition, the combined chronic/carcinogenicity study in rats is based on increased incidence of seizures and deaths, alterations in clinical chemistry (protein) and an increase in TSH and a decrease in T4 at the LOAEL of 0.059 mg/kg/day. No effects on body weights and body weigh gains were observed at the LOAEL in the chronic toxicity study. For this reason EPA believes that the additional 3X safety factor is protective of infants and children. However, the developmental neurotoxicity study identified a developmental NOAEL (0.05 mg/kg/day) which is less than the maternal NOAEL of 0.9 mg/kg/day, indicating an apparent susceptibility issue. EPA determined that the evidence regarding appearance of susceptibility was not convincing for several reasons. First, the findings at 0.9 mg/kg/day in the developmental neurotoxicity study (decrease in offspring body weight and delayed time to preputial separation) were equivocal. EPA, using a conservative approach, established the LOAEL for offspring developmental toxicity at 0.9 mg/kg/day with the understanding that these effects, although statistically significant, were marginal and appeared to define a threshold response level. This conservative approach resulted in the NOAEL for offspring developmental toxicity (0.05 mg/kg/day) being lower than the NOAEL for maternal toxicity (0.9 mg/kg/day) giving an appearance of increased susceptibility. Second, the findings in the developmental neurotoxicity study were not supported by the overall weight-of-the-evidence from the fipronil database. Evaluation of the database indicated that: • The offspring body weight findings in the developmental neurotoxicity study are not supported by the results of the 2-generation reproduction study in rats at similar treatment levels. • Increased susceptibility to the offspring was not demonstrated following prenatal and/or postnatal dosing in the prenatal developmental toxicity study nor the 2-generation reproduction study in rats. • No increased susceptibility was seen in the prenatal developmental toxicity study in rats following *in utero* exposure to the photodegradate, MB46513. More specific information may be found in the referenced document, “Fipronil: Third Reevaluation—Report of the Hazard Identification Assessment Review Committee, December 6, 2000,” available in the docket established by this action, as noted in this unit. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for fipronil is complete for food use. ii. The weight of the evidence does not indicate that there is increased sensitivity in young animals. In any event, there is a clear NOAEL identified in the one study where there was an appearance of sensitivity in the young. The degree of concern for prenatal and/or postnatal toxicity is low. iii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated
(CT)and anticipated residues were used as described in this unit. They are based in reliable data and will not underestimate the exposure and risk. Conservative ground and surface water modeling estimates were used. Similarly conservative Residential Standard Operating Procedures
(SOPs)were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fipronil. 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 level of concern
(LOC)by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fipronil will occupy 25% of the aPAD for the population group (children 1-2 years old) receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fipronil from food and water will utilize 96% of the cPAD for the population group (children (1-2 years old). Based the use pattern, chronic residential exposure to residues of fipronil is not expected. 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). Fipronil is currently registered for use that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fipronil. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs as follows: The short-term aggregate risk assessment takes into account average exposure estimates from dietary consumption of fipronil (food and drinking water) and non-occupational exposures (pet uses). Postapplication exposure from the use on pets is considered short-term. Therefore, a short-term aggregate risk assessment was conducted, using children with combined dermal and oral exposures from pet uses as a worst case. Table 3 of this unit summarizes the results. Since the LOC is different for oral and dermal exposures, 300 and 100, respectively, the Aggregate Risk Index
(ARI)method was used to determine short-term aggregate risk. The aggregate ARI from food, water, and non-occupational exposures is 1.5. Therefore, short-term aggregate risk estimates do not exceed the Agency’s level of concern (i.e. ARIs greater than or equal to 1). Adult post-application risk is considered negligible and so an aggregate risk assessment for adults is not considered necessary. **Table 3.—Aggregate Short-Term** Population Food + Water LOC 1 MOE 2 Oral LOC MOE Dermal LOC MOE ARI 3 Aggregate 4 Children (1-2 years old) 300 532 300 3,300 100 5,000 1.5 1 LOC=Level of Concern 2 MOE= NOAEL (or LOAEL)÷exposure 3 ARI=MOE <sup>Calculated</sup> ÷MOE <sup>LOC</sup> 4 ARI= <sup>Aggregate</sup> = 1÷((1÷ARI <sup>food</sup> )+(1÷ARI <sup>oral)</sup> +(1÷ARI <sup>dermal</sup> )). 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). Fipronil is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for fipronil. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs as follows: Intermediate-term risk to children is not expected to be higher than short-term risk due to the lack of inhalation exposure and a soil ingestion MOE of 1 million. 5. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fipronil residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (Method EC-95-303) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs)established for fipronil + metabolites MB46136 and MB45950 + photodegradate MB46513 on the commodities included in this request. C. Response to Comments One comment was received from a private citizen who opposes the approval of any pesticide that leaves a residue on food. The comment contained no specific information pertaining to fipronil but was limited to general claims such as EPA was providing inadequate protection for Americans. The Agency has received the same comment from this commenter on numerous previous occasions and rejects it for the reasons previously stated in the **Federal Registers** of January 7, 2005 (70 FR 1349) (FRL-7691-4), June 30, 2005 (70 FR 37686) (FRL-7718-3), and October 29, 2004 (69 FR 63096) (FRL-7681-9). V. Conclusion Therefore, the tolerances are established for combined residues of fipronil (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfinyl]-1H-pyrazole-3-carbonitrile) and its two metabolites MB45950 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-carbonitrile), in or on potato at 0.03 ppm, potato, wet peel at 0.1 ppm and indirect or inadvertent residues of fipronil and its metabolites and its degradate on wheat, forage at 0.02 ppm, wheat, grain at 0.005 ppm, wheat, hay at 0.03 ppm, and wheat, straw at 0.03 ppm. Time-limited tolerances are also established for combined residues of fipronil and its metabolites and degradate on turnip at 1.0 ppm and rutabaga at 1.0 ppm. The registrant petitioned for tolerances on vegetable, tuberous corm, subgroup 1C. In evaluating this petition, the Agency determined that planting methods associated with the different members of crop subgroup vegetable, tuberous corm, subgroup 1C result in different amounts of fipronil and its metabolites and degradate being loaded into the environment. Further, because of the planting depth of potatoes, the environmental loading of fipronil and its metabolites and degradate is expected to be lower for potatoes than other members of vegetable tuberous corm crop group 1C and is expected to be below levels of concern. For this reason, the Agency is establishing tolerances only for potato and the rotational crop wheat at this time. The Agency is working to resolve these issues as they relate to other members of vegetable tuberous corm crop group 1C. VI. Statutory and Executive Order Reviews This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this 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, or are established under section 408(l)(6) 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). 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 3, 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. 517 is amended by alphabetically adding commodities to the table in paragraph
(a)and by adding text to paragraphs
(b)and
(d)to read as follows: § 180.517 Fipronil; tolerances for residues.
(a)* * * Commodity Parts per million * * * * * Potato 0.03 Potato, wet peel 0.10
(b)*Section 18 emergency exemptions* . Time-limited tolerances are established for combined residues of the insecticide, fipronil, 5-amino-1-(2,6-dichloro-4-(trifluoromethyl) phenyl)-4-((1,R,S)-trifluoromethyl)sulfinyl)-1-H-pyrazole-3-carbonitrile and its 2 metabolites MB45950 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)thio]-1H-pyrazole-3-carbonitrile) and MB46136 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl)-4-[(trifluoromethyl)sulfonyl]-1H-pyrazole-3-carbonitrile) and its photodegradate MB46513 (5-amino-1-(2,6-dichloro-4-(trifluoromethyl)phenyl]-4-[(1R,S)-(trifluoromethyl)]-1H-pyrazole-3-carbonitrile), 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 table for this paragraph. Commodity Parts per million Expiration/revocation date Rutabaga 1.0 12/31/10 Turnip 1.0 12/31/10
(d)*Indirect or inadvertent residues* . Tolerances are established for combined indirect or inadvertent residues of the insecticide fipronil and its metabolites and photodegradate in or on food commodities when present therein as a result of the application of fipronil to growing crops listed in paragraphs
(a)and
(b)of this section and other nonfood crops to read as follows: Commodity Parts per million Wheat, forage 0.02 Wheat, grain 0.005 Wheat, hay 0.03 Wheat, straw 0.03 [FR Doc. E7-16621 Filed 8-21-07; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0889; FRL-8142-4] Pyriproxyfen; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of pyriproxyfen in or on animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; animal feed, nongrass, group 18, seed; banana; beet, sugar, dried pulp; cacao bean, dried; caneberry, subgroup 13-A; canola, seed; coffee, instant; coffee, green bean; cranberry; date; grain, cereal, group 15; grain, cereal, forage, fodder and straw, group 16; pawpaw; peanut; pineapple; pineapple, process residue; pomegranate; potato, chips; potato, granules/flakes; potato, wet peel; rice, hulls; safflower, seed; sesame, seed; sugarcane; tea; vegetable, bulb, group 3, except onion, bulb; and vegetable, root and tuber, group 1. Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540 requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective August 22, 2007. Objections and requests for hearings must be received on or before October 22, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0889. 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: Shaja R. Brothers, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-3194; e-mail address: *brothers.shaja@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to 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-2006-0889 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 22, 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-2006-0889, 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 November 22, 2006 (71 FR 67571) (FRL-8102-2), 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 6E7003) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.510 be amended by establishing tolerances for residues of the insecticide, pyriproxyfen, 2-1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on vegetable, root and tuber, group 1 at 0.15 part per million (ppm); vegetable, leaves of root and tuber, group 2 at 2.0 ppm; vegetable, bulb, group 3, except onion, dry bulb at 0.70 ppm; vegetable, leafy, except brassica, group 4 at 2.0 ppm; vegetable, legume, group 6 at 0.2 ppm; vegetable, foliage of legume, group 7 at 2.0 ppm; caneberry, subgroup 13A at 1.0 ppm; grain, cereal, group 15 at 1.1 ppm; grain, cereal, forage, fodder and straw, group 16 at 1.1 ppm; animal feed, nongrass, group 18 at 0.7 ppm for forage, 2.0 for seed, and 1.1 for hay; asparagus at 2.0 ppm; banana and plantain at 0.2 ppm; cacao bean at 0.02 ppm; canola, seed at 0.20 ppm; coffee at 0.02 ppm; cranberry at 1.0 ppm; date at 0.3 ppm; grass, forage at 0.5 ppm; grass, hay at 1.0 ppm; kiwifruit at 0.1 ppm; pawpaw at 1.0 ppm; peanut at 0.2 ppm; pineapple at 0.3 ppm; pomegranate at 0.20 ppm; safflower, seed at 0.2 ppm; sesame, seed at 0.02 ppm; sugarcane at 1.1 ppm; tea at 0.02 ppm; watercress at 2.0 ppm; and artichoke, globe at 2.0 ppm. That notice referenced a summary of the petition prepared by Valent USA Corporation, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . One comment was received on the notice of filing. EPA's response to comment is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has determined that proposed tolerances for vegetable, leaves of root, and tuber, group 2; vegetable, leafy, except, Brassica, group 4; vegetable, legume, group 6; vegetable, foliage of legume, group 7; artichoke, globe; asparagus; kiwifruit; and watercress will not be established at this time. Further, the Agency is establishing the following additional tolerances in conjunction with the tolerances that were requested: Beet, sugar, dried, pulp; potato, granules/flakes; potato, chips; potato, wet peel; rice, hulls; coffee, instant; and pineapple, process residue. The reason for these changes is explained in Unit IV. 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 pyriproxyfen 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 pyriproxyfen 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 pyriproxyfen 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 pyriproxyfen 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 pyriproxyfen on animal feed, nongrass, group 18, forage at 0.70 ppm; animal feed, nongrass, group 18, hay at 1.1 ppm; animal feed, nongrass, group 18, seed at 2.0 ppm; banana at 0.20 ppm; beet, sugar, dried pulp at 3.0 ppm; cacao bean, dried at 0.02 ppm; caneberry, subgroup 13-A at 1.0 ppm; canola, seed at 0.20 ppm; coffee, instant at 0.10 ppm; coffee, green bean at 0.02 ppm; cranberry at 1.0 ppm; date at 0.30 ppm; grain, cereal, group 15 at 1.1 ppm; grain, cereal, forage, fodder and straw, group 16 at 1.1 ppm; pawpaw at 1.0 ppm; peanut at 0.20 ppm; pineapple at 0.30 ppm; pineapple, process residue at 1.1 ppm; pomegranate at 0.20 ppm; potato, chips at 0.75 ppm; potato, granules/flakes at 0.75 ppm; potato, wet peel at 0.75 ppm; rice, hulls at 5.5 ppm; safflower, seed at 0.20 ppm; sesame, seed at 0.02 ppm; sugarcane at 1.1 ppm; tea at 0.02 ppm; vegetable, bulb, group 3, except onion, bulb at 0.70 ppm; and vegetable, root and tuber, group 1 at 0.15 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow. 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 pyriproxyfen 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.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-14/p12022.htm* in **Federal Register** of May 14, 2003 (68 FR 25831) (FRL-7305-9). 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for pyriproxyfen used for human risk assessment can be found at *www.regulations.gov* in document title Pyriproxyfen Human Health Risk Assessment Use on Numerous Crops. IR-4 Tolerance Plan (Reduced Data Set Translations) on pages 9-10 in Docket ID EPA-HQ-OPP-2006-0889. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to pyriproxyfen, EPA considered exposure under the petitioned-for tolerances as well as all existing pyriproxyfen tolerances in (40 CFR 180.510). EPA assessed dietary exposures from pyriproxyfen 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. No such effects were identified in the toxicological studies for pyriproxyfen; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA performed a Tier 1 chronic analysis which assumed 100% crop treated (CT), default processing factors, and tolerance level residues for all commodities. iii. *Cancer* . A cancer dietary risk assessment was not performed because no evidence of carcinogenicity has been found for pyriproxyfen. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for pyriproxyfen in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of pyriproxyfen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on EPA's Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-GROW) models, the estimated environmental concentrations
(EECs)of pyriproxyfen for acute and chronic exposures for surface water are estimated to be 2.15 parts per billion (ppb), and 0.40 ppb, respectively. The EEC for chronic exposure is estimated to be 0.006 ppb for groundwater. Both models assumed a maximum seasonal application rate of 0.11 lb ai/A, 3 times per year (citrus and stone fruit). Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.40 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Pyriproxyfen is the active ingredient in many registered residential products for flea and tick control (home environment and pet treatments) as well as products for ant and roach control (indoor and outdoor applications). Formulations include carpet powders, foggers, aerosol sprays, liquids (shampoos, sprays and pipettes for pet treatments), granules, bait (indoor and outdoor), and impregnated materials (pet collars). Only a post-application residential assessment was conducted as the Agency did not select any short-term dermal or inhalation endpoints. Toddlers are anticipated to have the highest exposures from treated home environments and pets due to typical hand-to-mouth behavior. EPA assessed residential exposure using the following assumptions: • Short-term, intermediate-term, and long-term toddler hand-to-mouth exposures (consisting of petting treated animals and touching treated carpets/flooring). • Long-term dermal exposures for products with anticipated efficacy more than 6 months (carpet powders and pet collars). • Combined treatment toddler exposure scenarios as a result of treatments to the home environment and the pet in the same period (such as carpet powder and pet shampoo treatments). Episodic ingestion of granules by toddlers is anticipated, but an assessment for this scenario is not included, since an acute dietary endpoint was not selected. 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 pyriproxyfen and any other substances and pyriproxyfen 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 pyriproxyfen 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* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. 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* . Based on the available data, there is no quantitative and qualitative evidence of increased susceptibility observed following *in utero* pyriproxyfen exposure to rats and rabbits or following prenatal/postnatal exposure in the 2-generation reproduction study. 3. *Conclusion* . EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for pyriproxyfen is complete. ii. There is no indication that pyriproxyfen is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. There is no evidence that pyriproxyfen results in increased susceptibility in *in utero* rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. Conservative ground water and surface water modeling estimates were used. Similarly conservative Residential Standard Operating Procedues
(SOPs)were used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyriproxyfen. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. *Acute risk* . No such effects were identified in the toxicological studies for pyriproxyfen; therefore, a quantitative acute risk assessment is unnecessary. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pyriproxyfen from food and water will utilize 10% of the cPAD for the population group children 1-2 years old. A long-term post-application residential assessment was performed for toddlers only since they are anticipated to have the higher exposures than adults from treated home environments and pets due to their behavior patterns. The total chronic dietary and residential aggregate MOEs range from 570 to 4,700. 3. *Short-term and intermediate-term risk* . Short and intermediate-term aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyriproxyfen is currently registered for use that could result in short-term and intermediate-term residential exposures and the Agency has determined that it is appropriate to aggregate chronic food and water for short-term and intermediate-term exposures for pyriproxyfen. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs range from 1,200 to 14,000 for children 1-2 years old, and females 13-49 years old, respectively. Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs range from 430 to 4,700 for children 1-2 years old, and females 13-49 years old, respectively. 4. *Aggregate cancer risk for U.S. population* . Pyriproxyfen is classified as a “Group E” chemical (negative for carcinogenicity to humans). This classification is based on the lack of evidence of carcinogenicity in mice and rats. EPA does not expect pyriproxyfen to pose a cancer risk. 5. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pyriproxyfen residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography/nitrogen-phosphorous detector (GC/NPD)) 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 no established Codex maximum residue limits
(MRLs)for pyriproxyfen. C. Response to Comments One comment was received by the Agency from a private citizen. The comment applies to the use of “available data” concerning the cumulative effects of the pesticide's residues and “other substances that have a common mechanism of toxicity.” In this case, EPA did not assume that this chemical has a common mechanism of toxicity with other substances as the chemical does not generate metabolites produced also by other chemicals. For specific information regarding EPA's approach to the use of common mechanism of toxicity to evaluate the cumulative effects of chemicals, please refer to EPA's website at *http://www.epa.gov/pesticides/cumulative/* to see policy statements. V. Conclusion Following review of the residue data submitted with the petition, EPA has made several revisions to the petition's request for the establishment of tolerances. First, due to absence of confirmatory data, the Agency is not establishing in this regulation the tolerances proposed for vegetable, leaves of root, and tuber, group 2; vegetable, leafy, except, Brassica, group 4; vegetable, legume, group 6; vegetable, foliage of legume, group 7; artichoke, globe; asparagus; kiwifruit; and watercress at this time. Second, EPA determined that proposed tolerances for various raw agricultural commodities (beets, potatoes, rice, coffee, pineapples) did not appropriately address residue levels that could occur in foods processed from those raw commodities. Accordingly, relying on the theoretical processing factors or processing factors from the Agency's pyriproxyfen database, EPA is establishing tolerances for the processed commodities of beet, dry pulp; potato granules/flakes, chips, and wet peel; rice, hulls; coffee, instant; and pineapple processed residue. Therefore, tolerances are established for residues of pyriproxyfen, 2-[1-methyl-2-(4-phenoxyphenoxy)ethoxypyridine, in or on the commodities listed in Unit III. paragraph 2. 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 9, 2007. Donald R. Stubbs, Acting 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 180.510 is amended by alphabetically adding the following commodities to the table in paragraph (a)(1) to read as follows: § 180.510 Pyriproxyfen; tolerances for residues.
(a)* * *
(1)* * * Commodity Parts per million * * * * * Animal feed, nongrass, group 18, forage 0.70 Animal feed, nongrass, group 18, hay 1.1 Animal feed, nongrass, group 18, seed 2.0 * * * * * Banana 0.20 Beet, sugar, dried pulp 3.0 * * * * * Cacao bean, dried 0.02 Caneberry, subgroup 13-A 1.0 Canola, seed 0.20 * * * * * Coffee, instant 0.10 Coffee, green bean 0.02 * * * * * Cranberry 1.0 * * * * * Date 0.30 * * * * * Grain, cereal, group 15 1.1 Grain, cereal, forage, fodder and straw, group 16 1.1 * * * * * Pawpaw 1.0 Peanut 0.20 Pineapple 0.30 Pineapple, process residue 1.1 * * * * * Pomegranate 0.20 Potato, chips 0.75 Potato, granules/flakes 0.75 Potato, wet peel 0.75 * * * * * Rice, hulls 5.5 * * * * * Safflower, seed 0.20 * * * * * Sesame, seed 0.02 Sugarcane 1.1 Tea 0.02 Vegetable, bulb, group 3, except onion, bulb 0.70 Vegetable, root and tuber, group 1 0.15 [FR Doc. E7-16310 Filed 8-21-07; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 36 [CC Docket Nos. 96-45 and 00-256; FCC 01-157] Federal-State Joint Board on Universal Service; Multi-Association Group
(MAG)Plan for Regulation of Interstate Services of Non-Price-Cap Incumbent Local Exchange Carriers and Interexchange Carriers; Correction AGENCY: Federal Communications Commission. ACTION: Correcting amendments. SUMMARY: This document contains corrections to the final regulations regarding rural high-cost universal service support that were published in the **Federal Register** of Tuesday, June 5, 2001, 66 FR 30080. The regulations relate to reforms to rural high-cost universal service support recommended by the Rural Task Force. DATES: Effective August 22, 2007. FOR FURTHER INFORMATION CONTACT: Katie King, Wireline Competition Bureau, Telecommunications Access Policy Division at
(202)418-7400 (voice),
(202)418-0484 (TTY), or e-mail at *Katie.King@fcc.gov.* SUPPLEMENTARY INFORMATION: Background The final regulations that are the subject of these corrections amended the Commission's rules relating to high-cost universal service support for rural carriers in response to recommendations of the Rural Task Force. Among other things, the amendments added §§ 36.602 and 36.603 to the Commission's rules and provided that, effective July 1, 2001, §§ 36.602 and 36.603 supersede § 36.601(c) of the Commission's rules. Section 36.622 of the Commission's rules previously contained a reference to § 36.601(c), and additional references to §§ 36.602 and 36.603 were inadvertently omitted in the final rules. Need for Correction As published, the final regulations omit references to rule sections that were added, and this omission may be misleading and needs to be corrected. List of Subjects in 47 CFR Part 36 Jurisdictional separations, Reporting and recordkeeping requirements, Telecommunications, Telephone. Federal Communications Commission. Marlene H. Dortch, Secretary. Accordingly, 47 CFR part 36 is corrected by making the following correcting amendments: PART 36—JURISDICTIONAL SEPARATIONS PROCEDURES; STANDARD PROCEDURES FOR SEPARATING TELECOMMUNICATIONS PROPERTY COSTS, REVENUES, EXPENSES, TAXES AND RESERVES FOR TELECOMMUNICATIONS COMPANIES Subpart F—Universal Service Fund 1. The authority citation for part 36 continues to read as follows: Authority: 47 U.S.C. 151, 154(i) and (j), 205, 221(c), 254, 403 and 410. 2. Revise paragraph (c)(2) of § 36.622 to read as follows: § 36.622 National and study area average unseparated loop cost.
(c)* * *
(2)Until June 30, 2001, an amount calculated to produce the maximum total Universal Service Fund allowable pursuant to § 36.601(c). Effective July 1, 2001, for non-rural carriers, an amount calculated to produce the maximum non-rural carrier portion of nationwide loop cost expense adjustment allowable pursuant to § 36.602. Effective July 1, 2001, for rural carriers, an amount calculated to produce the maximum rural incumbent local exchange carrier portion of nationwide loop cost expense adjustment allowable pursuant to § 36.603(a). [FR Doc. E7-16569 Filed 8-21-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [CC Docket No. 96-45; FCC 97-157] Universal Service; Correction AGENCY: Federal Communications Commission. ACTION: Correcting amendments. SUMMARY: This document contains corrections to the authority citation to the final regulations, 47 CFR Part 54, which were published in the **Federal Register** of Tuesday, June 17, 1997, 62 FR 32912. The regulations implemented the statutory requirements of the Telecommunications Act of 1996 relating to universal service. DATES: Effective August 22, 2007. FOR FURTHER INFORMATION CONTACT: Katie King, Wireline Competition Bureau, Telecommunications Access Policy Division at
(202)418-7400 (voice),
(202)418-0484 (TTY), or e-mail at *Katie.King@fcc.gov* . SUPPLEMENTARY INFORMATION: Background The final regulations that are the subject of these corrections implemented section 254 of the Communications Act of 1934, as amended, and relate to universal service. Section 254 was added to the Communications Act by section 101 of the Telecommunications Act of 1996 (Pub. L. 104-104, 110 Stat. 56). Need for Correction As published, the authority citation contains errors that may be misleading and needs to be corrected. List of Subjects in 47 CFR Part 54 Communications common carriers, Health facilities, Infants and children, Libraries, Reporting and recordkeeping requirements, Schools, Telecommunications, Telephone. Federal Communications Commission. Marlene H. Dortch, Secretary. Accordingly, 47 CFR part 54 is corrected by making the following correcting amendments: PART 54—UNIVERSAL SERVICE 1. The authority citation for part 54 is revised to read as follows: Authority: 47 U.S.C. 151, 154(i), 201, 205, 214, and 254 unless otherwise noted. [FR Doc. E7-16573 Filed 8-21-07; 8:45 am] BILLING CODE 6712-01-P 72 162 Wednesday, August 22, 2007 Proposed Rules DEPARTMENT OF HOMELAND SECURITY 6 CFR Part 5 Privacy Act of 1974: Implementation of Exemptions AGENCY: Office of the Secretary, Department of Homeland Security. ACTION: Notice of proposed rulemaking. SUMMARY: The Department of Homeland Security is giving concurrent notice of a revised and updated system of records pursuant to the Privacy Act of 1974 for the Arrival and Departure Information System (ADIS). In this proposed rulemaking, the Department proposes to exempt this system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements. DATES: Comments must be received on or before September 21, 2007. ADDRESSES: You may submit comments, identified by docket number DHS-2007-0050, by one of the following methods: *Federal e-Rulemaking Portal:* *http://www.regulations.gov* . Follow the instructions for submitting comments. *Fax:* 1-866-466-5370. *Mail:* Hugo Teufel III, Chief Privacy Officer, Department of Homeland Security, Washington, DC 20528. *Instructions:* All submissions received must include the agency name and docket number for this notice. All comments received will be posted without change to *http://www.regulations.gov* , including any personal information provided. *Docket:* For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: For general questions, contact Claire Miller, Acting US-VISIT Privacy Officer, 245 Murray Lane, SW., Washington, DC 20528. For privacy-related questions, contact Hugo Teufel III, Chief Privacy Officer, Department of Homeland Security, Washington, DC 20528; telephone
(703)235-0780. SUPPLEMENTARY INFORMATION: Background The Department of Homeland Security
(DHS)is republishing the Privacy Act system of records notice for the Arrival and Departure Information System
(ADIS)in order to expand its authority and capability to serve additional programs that require information on individuals throughout the immigrant and non-immigrant pre-entry, entry, status management, and exit processes. These changes include the addition of a routine use to allow sharing of information with the intelligence community in support of the DHS mission to protect the United States from potential terrorist activities; the addition of a routine use for cases of identity theft; clarification on the sources of data in ADIS, potentially including foreign governments; and a reduction of the retention period for ADIS data. The notice for this system of records was last published in the **Federal Register** on December 12, 2003 (68 FR 69412). In this notice of proposed rulemaking, DHS now is proposing to exempt ADIS from certain provisions of the Privacy Act. The Privacy Act embodies fair information principles in a statutory framework governing the means by which the United States Government collects, maintains, uses, and disseminates personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Individuals may request their own records that are maintained in a system of records in the possession or under the control of DHS by complying with DHS Privacy Act regulations, 6 CFR part 5. The Privacy Act requires each agency to publish in the **Federal Register** a description of the type and character of each system of records that the agency maintains, and the routine uses that are contained in each system in order to make agency recordkeeping practices transparent, to notify individuals regarding the uses to which personally identifiable information is put, and to assist individuals in finding such files within the agency. The Privacy Act allows Government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a notice of proposed rulemaking to make clear to the public the reasons why a particular exemption is claimed. DHS is claiming exemption from certain requirements of the Privacy Act for ADIS. Information in ADIS relates to official DHS national security, law enforcement, immigration, and intelligence activities. These exemptions are needed to protect information relating to DHS investigatory and enforcement activities from disclosure to subjects or others related to these activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating these processes; to avoid disclosure of activity techniques; to protect the identities and physical safety of confidential informants and of immigration and border management and law enforcement personnel; to ensure DHS's ability to obtain information from third parties and other sources; to protect the privacy of third parties; and to safeguard classified information. Disclosure of information to the subject of an inquiry could also permit the subject to avoid detection or apprehension. The exemptions proposed here are standard law enforcement and national security exemptions exercised by a large number of Federal law enforcement and intelligence agencies. In appropriate circumstances, where compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived. List of Subjects in 6 CFR Part 5 Freedom of information, Privacy. For the reasons stated in the preamble, DHS proposes to amend Chapter I of Title 6, Code of Federal Regulations, as follows: PART 5—DISCLOSURE OF RECORDS AND INFORMATION 1. The authority citation for part 5 continues to read as follows: Authority: Pub. L. 107-296, 116 Stat. 2135, 6 U.S.C. 101 et seq.; 5 U.S.C. 301. Subpart A also issued under 5 U.S.C. 552. Subpart B also issued under 5 U.S.C. 552a. 2. At the end of Appendix C to Part 5, add the following new paragraph “5” to read as follows: Appendix C—DHS Systems of Records Exempt from the Privacy Act 5. The Department of Homeland Security Arrival and Departure Information System
(ADIS)consists of centralized computerized records and will be used by DHS and its components. ADIS is the primary repository of data held by DHS for near real-time immigrant and non-immigrant status tracking through pre-entry, entry, status management, and exit processes, based on data collected by DHS or other Federal or foreign government agencies and used in connection with DHS national security, law enforcement, immigration, intelligence, and other DHS mission-related functions, and to provide associated testing, training, management reporting, planning and analysis, or other administrative uses. The information is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other Federal, state, local, tribal, foreign, or international government agencies. Pursuant to exemptions 5 U.S.C. 552a(j)(2) of the Privacy Act, this system is exempt from 5 U.S.C. 552a(c)(3) and (4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5), (e)(8); (f); and (g). Pursuant to 5 U.S.C. 552a (k)(2), this system is exempt from the following provisions of the Privacy Act, subject to the limitations set forth in those subsections: 5 U.S.C. 552a (c)(3); (d); (e)(1), (e)(4)(G), (e)(4)(H); and (f). Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request for release or disclosure is made, for the following reasons:
(a)From subsection (c)(3) and
(4)(Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.
(b)From subsection
(d)(Access to Records) because access to the records contained in this system of records could inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of that investigation and reveal investigative interest on the part of DHS or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and would impose an unreasonable administrative burden by requiring investigations to be continually reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to homeland security.
(c)From subsection (e)(1) (Relevancy and Necessity of Information) because in the course of investigations into potential violations of Federal law, the accuracy of information obtained or introduced occasionally may be unclear, or the information may not be strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of unlawful activity.
(d)From subsection (e)(2) (Collection of Information from Individuals) because requiring that information be collected from the subject of an investigation would alert the subject to the nature or existence of the investigation, thereby interfering with that investigation and related law enforcement activities.
(e)From subsection (e)(3) (Notice to Subjects) because providing such detailed information could impede law enforcement by compromising the existence of a confidential investigation or reveal the identity of witnesses or confidential informants.
(f)From subsections (e)(4)(G) and
(H)and
(f)(Agency Requirements) because portions of this system are exempt from the individual access provisions of subsection
(d)and thus would not require DHS to apply rules for records or portions of records which are exempted from access or amendment upon request. Access to, and amendment of, system records that are not exempt or for which exemption is waived may be obtained under procedures described in the related system of records notice
(SORN)or Subpart B of this Part.
(g)From subsection (e)(5) (Collection of Information) because with the collection of information for law enforcement purposes, it is impossible to determine in advance what information is accurate, relevant, timely, and complete. Compliance with subsection (e)(5) would preclude DHS agents from using their investigative training and exercise of good judgment to both conduct and report on investigations.
(h)From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS's ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal and could result in disclosure of investigative techniques, procedures, and evidence.
(i)From subsection
(g)(Civil Remedies) to the extent that the system is exempt from other specific subsections of the Privacy Act. Dated: August 15, 2007. John Kropf, Acting Chief Privacy Officer, Department of Homeland Security. [FR Doc. E7-16461 Filed 8-21-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services 8 CFR Parts 1, 264, and 299 [CIS No. 2354-05; DHS Docket No. USCIS-2005-0056] RIN 1615-AB36 Application Process for Replacing Forms I-551 Without an Expiration Date AGENCY: U.S. Citizenship and Immigration Services, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: U.S. Citizenship and Immigration Services (USCIS) issues Permanent Resident Cards (Forms I-551) to lawful permanent residents to serve as evidence of immigration status, registration, identity, and employment authorization, and as an entry document upon return from a trip outside of the United States. Currently, there are numerous lawful permanent residents who possess cards without expiration dates. USCIS intends to terminate the validity of such Forms I-551. This rule proposes to establish a 120-day period for lawful permanent residents who have Forms I-551 that do not bear expiration dates to apply for replacement cards. This rule also proposes to amend USCIS regulations to remove references to outdated application procedures for Forms I-551. The application process proposed by this rule will enable USCIS to issue more secure Forms I-551 to affected aliens, update cardholder information, conduct background checks, and electronically store applicants' biometric information that can be used for biometric comparison and authentication purposes consistent with the goals of the Enhanced Border Security and Visa Entry Reform Act of 2002. In addition, USCIS proposes to notify the public of the termination date for Forms I-551 without expiration dates by a subsequent Notice published in the **Federal Register** . This rule also proposes to correct the title and edition date of the “Application to Replace Lawful Permanent Resident Card,” Form I-90. DATES: Written comments must be submitted on or before September 21, 2007. ADDRESSES: You may submit comments, identified by DHS Docket No. USCIS-2005-0056, by one of the following methods: • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *E-mail:* You may submit comments directly to USCIS by e-mail at *rfs.regs@dhs.gov.* Include DHS Docket No. USCIS-2005-0056 in the subject line of the message. • *Mail:* The Chief, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security, 111 Massachusetts Avenue, NW., 3rd Floor, Washington, DC 20529. To ensure proper handling, please reference DHS Docket No. USCIS-2005-0056 on your correspondence. This mailing address may also be used for paper, disk, or CD-ROM submissions. • *Hand Delivery/Courier:* U.S. Citizenship and Immigration Services, Department of Homeland Security, 111 Massachusetts Avenue, NW., 3rd Floor, Washington, DC 20529. Contact Telephone Number is
(202)272-8377. FOR FURTHER INFORMATION CONTACT: R. Mark Phillips, Supervisory Adjudications Policy Officer, U.S. Citizenship and Immigration Services, 20 Massachusetts Ave., Suite 2304, Washington, DC 20529, telephone
(202)272-8350. SUPPLEMENTARY INFORMATION: I. Public Participation Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. The Department of Homeland Security
(DHS)and U.S. Citizenship and Immigration Services (USCIS) also invite comments that relate to the economic or federalism effects that might result from this proposed rule. Comments that will provide the most assistance to USCIS will reference a specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority to support such recommended change. *Instructions:* All submissions received must include the agency name and DHS docket No. USCIS-2005-0056 for this rulemaking. All comments received will be posted without change to *http://www.regulations.gov,* including any personal information provided. See ADDRESSES above for information on how to submit comments. *Docket:* For access to the docket to read background documents or comments received, go to *http://www.regulations.gov.* Submitted comments may also be inspected at the office of the Director, Regulatory Management Division, U.S. Citizenship and Immigration Services, Department of Homeland Security, 111 Massachusetts Avenue, NW., 3rd Floor, Washington, DC 20529. II. Background A. Statutory and Regulatory Authority and Purpose A lawful permanent resident
(LPR)is an alien who has been granted the privilege of permanently living and working in the United States (lawful permanent resident status), either by adjusting status from a prior immigration status within the United States or by being admitted to the United States on an immigrant visa issued abroad by the U.S. Department of State (DOS). In most cases, USCIS must first approve an immigrant petition for the intending immigrant. Typically, these petitions are filed by an employer (e.g., Form I-140, Immigrant Petition for Alien Worker) or relative (Form I-130, Petition for Alien Relative). After the petition is granted, individuals living within the United States can apply for adjustment of status with USCIS or, for those in removal proceedings, the immigration court, using Form I-485, “Application to Register Permanent Residence or Adjust Status.” Individuals living abroad must file an application for an immigrant visa with a DOS consular office. *See* 22 CFR 42.63(a)(1) (DS-230, Application for Immigrant Visa and Alien Registration). As part of the adjustment of status application process, applicants are required to appear at a local USCIS Application Support Center
(ASC)and submit to registration and biometrics capture by USCIS. Biometrics capture currently includes fingerprint imaging and a digital photograph. Following approval of an adjustment application or after admission to the United States on an immigration visa, the new LPR will receive a Form I-551, Permanent Resident Card. 1 (commonly referred to as a “green card”). A Form I-551 is evidence of the holder's authorization to live and work in the United States. *See* Immigration and Nationality Act
(INA)sections 264(d), 274A(b)(1)(B)(ii) (8 U.S.C. 1304(d), 1324a(b)(1)(B)(ii)); 8 CFR 264.1(b); 8 CFR 274a.2(b)(1)(v)(A)(2). 1 Form I-551 has two titles—Alien Registration Receipt Card and Permanent Resident Card—because it underwent a name change in January 20, 1999 from “Alien Registration Receipt Card” to “Permanent Resident Card,” and both versions of Form I-551 remain in circulation. 63 FR 70313 (Dec. 21, 1998). USCIS has been authorized to collect information and require the registration of aliens under section 262 of the INA, 8 U.S.C. 1302. Aliens registering with USCIS are required to provide information regarding the date and place of the alien's entry into the United States; the activities in which the alien has been and intends to be engaged; the length of time the alien expects to remain in the United States; the police and criminal record, if any, of the alien; and any additional matters prescribed by DHS or DOS. INA sec. 264(a), 8 U.S.C. 1304(a). All registered aliens over 18 years of age must carry evidence of registration. INA sec. 264(e), 8 U.S.C. 1304(e). The failure to carry evidence of registration is a misdemeanor offense. *Id.* The Form I-551 is a form of evidence of registration issued to individuals who are LPRs. 8 CFR 264.1(b). The Form I-551 also serves as evidence of employment authorization and identity (see 8 CFR 274a.2(b)(1)(v)(A)(2)), and is used as an entry document upon return from a trip outside the United States (see 8 CFR 211.1(a)(2)). Until 1989, Forms I-551 issued to LPRs did not contain expiration dates; therefore, those still in circulation do not require periodic replacement. *See* Memorandum from Commissioner James L. Buck on Alien Registration Documentation (Form I-551) (July 18, 1989). 2 In August 1989, however, the then-Immigration and Naturalization Service
(INS)began issuing Forms I-551 with a 10-year expiration date, thereby requiring the cardholder to apply periodically for a new card, and, in so doing, appear before USCIS to update personal information, the photograph contained on the card, and other biometric information, such as fingerprints. *See* 8 CFR 264.5(a), (b), (c); Instructions to Form I-90, “Application to Replace Permanent Resident Card.” The Form I-551 replacement process gives DHS an opportunity to collect updated biometric information, conduct background checks, and issue updated cards. 2 The public can access a copy of this memorandum from the public docket for this rulemaking at *http://www.regulations.gov* , DHS Docket No. USCIS-2005-0056. When the 10-year Form I-551 was introduced in 1989, it was not administratively feasible for the INS to terminate the validity of all the millions of Forms I-551 in circulation that did not have expiration dates. USCIS now has established processes to enable it to require LPRs with Forms I-551 without expiration dates to apply for new cards and terminate the validity of Forms I-551 without expiration dates. These processes include the establishment, in 1997 and 1998, of Application Support Centers
(ASCs)across the United States that, through electronic scheduling of appointments, currently serve as efficient intake centers. In addition, biometrics began to be captured electronically in 1999. Finally, USCIS implemented a new, highly-automated filing procedure in May 2005 where applicants file their Forms I-90 with a U.S. Treasury Department-designated and operated lockbox provider that allows USCIS to process the applications and associated fees more expeditiously. As a result of these improvements, USCIS now has the capability to process a large influx of Forms I-90 over a short period of time. The need to remove Forms I-551 without expiration dates from circulation is supported by the Enhanced Border Security and Visa Entry Reform Act of 2002 (“BSA”), Public Law 107-173, 116 Stat. 543 (May 14, 2002), amended by Public Law 108-299, 118 Stat. 1100 (Aug. 9, 2004). Section 302(b)(1) of the BSA, 8 U.S.C. 1732(b)(1), requires the Secretary of Homeland Security and the Secretary of State, to issue, not later than October 26, 2004, only machine-readable, tamper-resistant visas and other travel and entry documents that use biometrics identifiers. The Form I-551 falls within the scope of the BSA because, in addition to serving as evidence of registration, it also serves as an entry document for LPRs returning to the United States after a trip abroad. *See* 8 CFR 211.1(a)(2). Prior to October 26, 2004, USCIS determined that the Form I-551 was compliant with the requirements of section 302(b)(1) of the BSA, 8 U.S.C. 1732(b)(1). The Form I-551, including the version that does not contain an expiration date, is machine-readable and contains tamper-resistant features and biometrics identifiers. While compliant, older versions of the Form I-551 without expiration dates do not contain the same level of tamper-resistant features and biometric identifiers as the current version. Forms I-551 with expiration dates must be renewed periodically, at which point USCIS can issue new cards containing updated technologies and biometrics information. This is not possible for Forms I-551 without expiration dates. Consequently, in order to ensure that the Forms I-551 in circulation contain the higher level of tamper-resistant features and biometric identifiers that currently-issued cards contain, USCIS intends to terminate the validity of Forms I-551 without expiration dates. In addition, USCIS must ensure that it maintains current biometrics to enable it to conduct background checks on Form I-551 holders to confirm that they are compliant with the laws of the United States and that they are not a threat to national security. By periodically requiring all Form I-551 holders to apply for replacement cards, USCIS will be able to confirm this information and update background and biometric information. For these reasons, USCIS proposes to set the form, manner and time that alien registration receipt cards are issued as authorized under section 264(d) of the INA, 8 U.S.C. 1304(d). The rule proposes to amend the regulations to require bearers of Forms I-551 without expiration dates to apply for a replacement card during a 120-day application period. This proposed rule also amends the regulations governing the application process for replacing Forms I-551 and makes technical corrections to the title of the application used to replace Forms I-551. Finally, this rule proposes a mechanism for terminating Forms I-551 without an expiration date by notice in the **Federal Register** . B. Changes Made by This Rule 1. Requirement To Replace Forms I-551 Without Expiration Dates This rule proposes to amend 8 CFR 264.5(c)(1) to add Form I-551 without an expiration date to the current list of outdated permanent resident cards that are required to be replaced by the filing of Form I-90, “Application to Replace Permanent Resident Card.” The current list consists of Forms AR-3, AR-103, and I-151. This proposed amendment also would impose a 120-day application period for those LPRs holding Forms I-551 without an expiration date to apply for a replacement card. Through the Form I-90 application process, applicants would be required to provide their current biographic and biometric information. Based on this information, USCIS would conduct security checks to verify the identity of card recipients and continued eligibility for LPR status. USCIS would charge the standard, Form I-90 application fee and the biometric information collection service fee to cover all associated costs. The current fees are $290 for the Form I-90 and $80 for the biometric information collection service. 3 After completion of the 120-day application period, USCIS would set a termination date for the validity of such Forms I-551. 3 If an applicant is able to demonstrate that he or she is unable to pay the standard Form I-90 fee and/or the biometric service fee associated with the filing of a Form I-90, he or she may request a fee waiver pursuant to 8 CFR 103.7(c). However, at present, USCIS does not waive the biometric service fee associated with the filing of a Form I-90. 69 FR 20528, 20529 (Apr. 15, 2004). USCIS believes that an application period of 120 days will be sufficient for affected LPRs to learn of the new requirement and to complete the required Form I-90. USCIS plans to conduct an extensive outreach program to alert the affected group of LPRs of the need to apply for new cards. This outreach program would include issuing press releases, posting program announcements and question-and-answer (Q&A) documents to the USCIS website, distributing fliers and pamphlets at USCIS field offices, and conducting informational meetings with community-based organizations (CBOs). USCIS also will encourage applicants to file the Form I-90 electronically, rather than on paper. In general, USCIS can process I-90 applications submitted electronically faster than those applications filed on paper. The application form itself is not complicated and takes an estimated average time of 55 minutes to complete. USCIS seeks public comment on the application period. After the 120-day application period expires, LPRs who failed to timely file Forms I-90 to replace their Forms I-551 would still be required to apply for a replacement card. An alien who fails to file a Form I-90 during this application period will still hold the status of an alien who has been lawfully admitted for permanent residence, since this status continues until it is terminated by entry of a removal order against the alien. 8 CFR 1.1(p). The alien will not, however, be in compliance with the requirement under section 264(e) of the Act, 8 U.S.C. 1304(e), that the alien must have in his or her possession at all times the evidence of his or her having registered. To obtain new evidence of registration, the alien will need to file a Form I-90. For any alien who does not file before the application period expires, however, USCIS would not be able to ensure that the alien will receive a new Form I-551 before the old Form I-551 is deemed to have expired. Strictly speaking, an alien who is at least 18 years old, who fails to file a timely Form I-90, and whose current Form I-551, therefore, expires, could be prosecuted for violating section 264(e). If convicted, the person could be sentenced to pay a fine of up to $100, to imprisonment for up to 30 days, or both. It is also a misdemeanor under section 266(a) of the Act, 8 U.S.C. 1306(a), for an alien to fail to register as required. The alien can be prosecuted for failure to register, however, only if the failure to register is proven to be willful. USCIS does not anticipate that either of these criminal sanctions would be routinely used against aliens who fail to obtain new Forms I-551. The far more common action, should USCIS discover that an alien's Form I-551 has expired, will be to advise the alien to file a Form I-551 to obtain a new Form I-551. If the alien still fails to apply for a new Form I-551, it may become feasible to prove that the failure to do so is willful. USCIS anticipates, however, that aliens will, generally, comply with the requirement to obtain a new Form I-551, once they become aware of the requirement. Once implemented as a final rule, LPRs affected by the requirements proposed under this rule may choose to apply for naturalization during the 120-day application period instead of a new Form I-551. However, USCIS would not be able to guarantee the completion of its adjudication of such naturalization applications before it terminates the validity of Forms I-551 without expiration dates. For those LPRs who have applied for, but do not receive, a grant of naturalization by the time USCIS sets the termination date, USCIS may issue interim evidence of registration. 2. Termination of the Validity of Forms I-551 Without an Expiration Date Forms I-551 without an expiration date will remain valid throughout the 120-day application period that will be set by the final rule for replacing such Forms I-551. After the 120-day application period, USCIS will assess the number of applications received and the timeframes for application processing and card production. Once USCIS has processed the applications and issued replacement Forms I-551, USCIS will be in a position to set a date for terminating the validity of Forms I-551 without expiration dates. This rule proposes amendments to 8 CFR 264.5(c)(1) to provide that USCIS will announce the termination date after the 120-day application period through a Notice published in the **Federal Register** . USCIS is proceeding in this way to minimize the possibility that applicants will not have received a replacement Form I-551 in hand when the validity of their previous Form I-551 is terminated. USCIS cannot precisely estimate the number of applications it will receive to allow USCIS to plan exact timelines for card production and, in turn, a termination date. USCIS will only be able to set timelines based upon the actual volume of applications received. Issuing a separate Notice published in the **Federal Register** to advise the public of the termination of the validity of Forms I-551 without expiration dates would allow USCIS to implement a termination date that accommodates USCIS's processing needs and applicants' need for valid documentation. In addition to establishing the mechanism for terminating Forms I-551 without expiration dates, this rule also clarifies that “Form I-551,” when used elsewhere in the regulations, means a valid, unexpired Form I-551. To do so, this proposed rule would amend the list of terms defined in 8 CFR 1.1 by adding a limiting definition of Form I-551. Current regulations do not define Form I-551; instead, the regulations identify its uses. As stated earlier in this Supplementary Information, the regulations identify Form I-551 as an entry document in 8 CFR 211.1(a)(2), evidence of registration in 8 CFR 264.1(b), an immigration status document in 8 CFR 274a.12(a)(1), and a combination identity and employment authorization document in 8 CFR 274a.2(b)(1)(v)(A)(2). These references to Form I-551 apply to both the version of the card with an expiration date and the version of the card without an expiration date. This rule proposes introducing a limiting definition of Form I-551 rather than amend each reference so that it is clear to the public what constitutes a valid Form I-551 with respect to any of its uses, particularly following the termination date of the validity of Forms I-551 without an expiration date. This rule proposes to limit the term, “Form I-551” to mean the version of the form with an expiration date. See proposed 8 CFR 1.1(AA). A Form I-551 that does not bear an expiration date would not be valid for any use under the regulations unless otherwise specifically provided in the regulations. *Id.* Until the validity of Forms I-551 without an expiration is terminated via Notice published in the **Federal Register** , this rule, at 8 CFR 264.1(c)(1), proposes that such Forms I-551 would remain valid. To do otherwise would have the effect of prematurely terminating the validity of Forms I-551. The current regulations permit the use of expired Forms I-551 in other circumstances as well. For example, an expired Form I-551 may be used for entry to the United States and for presenting evidence of identity to an employer. 8 CFR 211.3 (entry); 8 CFR 274a.2(b)(1)(v)(B)(1)(v) (identity). Under this proposed rule, such Forms I-551 and those without expiration dates would remain valid in these instances. It is important to note that the planned termination of Forms I-551 without expiration dates as proposed under this rule would not affect the immigration status and employment authorization of the holders of such cards; they remain LPRs and their employment is authorized incident to status. *See* INA 274A(h)(3)(A), 8 U.S.C. 1324a(h)(3)(A); 8 CFR 274a.12(a). Under the requirements proposed in this rule, an LPR who fails to obtain a new Form I-551 by the I-551 termination date would not be in possession of a valid Form I-551. As a result, he or she may experience difficulties in meeting other requirements where valid documentation is necessary. For example, the LPR with an invalid Form I-551 may experience difficulty returning to the United States after a trip abroad or in obtaining new employment, and would not be in possession of valid registration documentation. *See* 8 CFR 211.1(a) (entry to the United States); 8 CFR 274a.2(b)(1)(v)(A) (employment ); 8 CFR 264.1(b) (registration). 3. Changes to the Application Process for Replacing Forms I-551 This rule also proposes amending the regulations at 8 CFR 264.5(e) to update the application procedures for replacing Forms I-551. Current regulations at 8 CFR 264.5(e) cover the following application requirements: The documentation that must accompany Form I-90 upon filing, including the Permanent Resident Card being replaced, photographs, evidence of name change, and signature on the Data Collection Form (Form I-89); proper filing locations; fingerprint submissions; interviews; and waiver of the photograph, in-person filing, and signature requirements. Form I-90 processing procedures are also provided in the instructions to the Form I-90. Because the form instructions are more current, some of the information in the form instructions reflect changes to procedures that are not also reflected in 8 CFR 264.5(e). Whereas 8 CFR 264.5(e)(1) requires the submission of photographs and supporting documentary evidence with the application upon filing, current form instructions provide that this biometric information and evidence will be accepted by USCIS when the applicant appears at an Application Support Center
(ASC)(a USCIS facility that captures biometrics) following submission of the application. In addition, 8 CFR 264.5(e)(2)(i) provides that applicants must file Forms I-90 with the local office or Service Center having jurisdiction over their place of residence; instructions to the Form I-90 provide that the application must be submitted to the lockbox address specified in the instructions or filed electronically. Finally, while 8 CFR 264.5(e)(3)(i) only requires applicants who are replacing their Permanent Resident Cards because they have reached 14 years of age to submit to fingerprinting, the instructions to the Form I-90 require all applicants to appear at a USCIS ASC to submit to biometrics capture. Biometrics capture is a broader term than fingerprinting and covers fingerprints, photographs, and signatures. 69 FR 5088, 5090 (Feb. 3, 2004) (proposing a fee increase for biometric capture services, as well as other immigration and naturalization benefits and services). To ensure that applicants receive clear and consistent filing information, this rule proposes to revise 8 CFR 264.5(e) in its entirety to remove outdated filing instructions, refer applicants to the instructions accompanying the form, and update biometrics capture requirements. Proposed 8 CFR 264.5(e) includes a paragraph on filing requirements, biometrics capture, and interviews. Rather than specify the filing requirements, this proposed rule refers applicants to the Form I-90 instructions. Proposed 8 CFR 264.5(e)(1). The Form I-90, including the filing instructions, is available on the USCIS Web site at *http://www.uscis.gov.* USCIS has determined that filing information is better placed in form instructions alone, which are reviewed and updated periodically and are more accessible to the public than regulatory provisions. By providing one source for stating the filing requirements, USCIS will avoid confusion and potential conflict between the requirements stated in the regulations and those stated in the form instructions. This rule also proposes to amend USCIS regulations to reflect the biometrics capture requirements in the current Form I-90 instructions. Proposed 8 CFR 264.5(e)(2). Those instructions require all applicants to appear at an ASC for biometrics capture and pay a separate biometrics fee with the Form I-90 filing. By contrast, the current regulations require all applicants to provide a photograph and signature, but only require individuals replacing their Form I-551 on the basis that they have turned 14 years of age to be subject to fingerprinting. *See* 8 CFR 264.5(e)(3)(i). This rule proposes to amend the regulations to require all applicants to submit to all of the types of biometrics capture, including fingerprinting. USCIS is proposing to expand the fingerprinting requirement to all Form I-90 applicants to enable USCIS to obtain current biometrics information needed for Form I-551 card production, conduct appropriate background checks before cards are issued, and store this information for biometrics comparison and authentication purposes required by section 302(b)(2)(A) of the BSA, 8 U.S.C. 1732(b)(2)(A). Note, in particular, that this proposed rule would change the current provision in current 8 CFR 264.5(e)(3)(iii) concerning the USCIS authority to waive the submission of biometric information. In light of the security concerns arising from the September 11, 2001, terrorist attack on the United States, it has been USCIS policy not to exercise this authority by actually waiving the photograph or other requirements. See Memorandum from William R. Yates for Regional Directors and Center Directors, Alterations to the ADIT photograph requirements (September 4, 2003) Memorandum from Johnny N. Williams for Regional Directors, Waiver of Photograph for I-90 Applicants Seeking Replacement or Renewal Form I-551 (February 14, 2003). The Memoranda are included in the public docket for this rule at *http://www.regulations.gov,* DHS Docket No. USCIS-2005-56. A Form I-551 without a photograph of the person to whom it relates does not serve the essential purpose of the Form I-551: To provide for a ready means of identifying the actual person who has been lawfully admitted for permanent residence. In the case of an alien who is physically unable to come to a USCIS facility due to advanced age or physical infirmity, the practice has not been actually to *waive* the photograph and other biometrics requirements. Instead, the practice has been to provide an alternative means for collecting this evidence. The most common practice is to permit the applicant to provide passport-style photographs, police clearance letters, and other appropriate evidence. The rule, once final, would retain the provisions governing waivers of the biometrics capture requirement in current 8 CFR 264.5(e)(3)(iii) and interviews in current 8 CFR 264.5(e)(3)(ii), except that the provisions are renumbered to new 8 CFR 264.5(e)(2) and (e)(3). In addition, the rule simplifies the text of these provisions; no substantive changes are proposed. This rule also proposes technical corrections to 8 CFR 299.1 and 299.5 by adding the updated edition date (03/31/05) and title of the Form I-90 to those sections. The Form I-90's proper title is “Application to Replace Permanent Resident Card.” The form was revised to reflect this title; however, the regulations listing immigration forms were never revised. III. Regulatory Requirements A. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)(5 U.S.C. 605(b)), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996 (SBRFA), requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions). DHS has considered the impact of this rule on small entities and has determined that this rule will not have a significant economic impact on a substantial number of small entities. The individual lawful permanent residents to whom this rule applies are not small entities as that term is defined in 5 U.S.C. 601(6). There is no change expected in any process as a result of this rule that would have a direct effect, either positive or negative, on a small entity. Accordingly, this rule, once final, will not have a significant economic impact on a substantial number of small entities. B. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local and tribal governments in the aggregate of $100 million or more in any one year. However, as discussed below under Executive Order 12866, this action will result in the expenditure by the private sector of more than $100 million over the period of time that the program is in place. Only holders of Forms I-551, “Permanent Resident Cards,” without expiration dates will bear the costs of this rule. C. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule, once final, will result in an effect on the economy of approximately $290 million in the first year after this rule is published, $24 million in the second year after this rule is published, and $13 million in the third year after this rule is published. This increase is directly associated with the expected increase in the number of Forms I-90 and amount of accompanying filing and biometrics fees that USCIS will receive to replace Forms I-551, “ Permanent Resident Cards,” without expiration dates prior to termination of such cards. D. Executive Order 12866 This rule has been identified as an economically significant rule under Executive Order 12866, section 3(f)(1), Regulatory Planning and Review. Accordingly, this rule has been submitted to the Office of Management and Budget for review. USCIS has assessed both the costs and benefits of this rule, as required by Executive Order 12866, and has made a reasoned determination that the benefits justify the costs. USCIS estimates that 750,000 persons will apply for a replacement Form I-551, “Permanent Resident Card,” in accordance with this rule. The most likely estimated cost of this rule for these persons is $327 million over a three-year period of analysis (2007-2009). Over the three-year period of analysis, the present value cost of this proposed rule is approximately $267 million at 7%. A three-year period of analysis was chosen since those aliens who are required by this rulemaking to obtain a new Form I-551 will do so only in 2007, 2008, and 2009. The $327 million estimate consists of $278 million in fees associated with the Form I-90, $42 million in opportunity cost for an applicant's time, and $7 million in transportation costs for round trip transit to the nearest USCIS Application Support Center (ASC). The calendar year breakdown of these costs is $290 million for Calendar Year
(CY)2007 ($278 million in fees plus $12 million in applicant time and transportation costs), $24 million for CY 2008 (applicant time and transportation costs), and $13 million for CY 2009 (applicant time and transportation costs). The cost assessment, which includes a discussion of both the maximum and most likely estimated costs of this rule, follows. In an effort to improve the security of the documents that USCIS issues for use by the public, this rule calls for a 120-day period, beginning 30 days from the date of publication of the final rule in the **Federal Register** , within which time LPRs holding Forms I-551 without expiration dates must apply to replace their card. To apply, they must file Form I-90 with a fee of $290 and an additional biometrics capture fee of $80. The total current cost is $370. Those who apply for a replacement Form I-551 under this rule must submit biometrics that will be used for background checks and stored for future use. Based on technology and processes being developed by DHS, stored biometrics will be available for access by DHS for other immigration and law enforcement uses (a security benefit to the public at large), and these applicants might not need to return to an ASC for purposes of triggering certain background checks such as FBI fingerprints, should they decide to naturalize or apply for a replacement Form I-551 in the future. The primary benefit to the government resulting from this rule is enhanced national security. Once the program is complete, all LPRs will have Forms I-551 with late-model technology. The biometrics of the rightful holder will be electronically stored in a secure DHS database that is easily retrievable and that can be used for data matching purposes among the DHS components. The card itself will bear a current photograph, facilitating its use by employers and the travel industry. USCIS considered a number of alternatives to this proposed rulemaking. One alternative was for USCIS to maintain the current regulations. However, such an action would result in the agency's failure to fully meet the goals of section 303(b) of the BSA, 8 U.S.C. 1732(b). Another alternative was to expire pre-1989 cards, but lower the fees for replacing the cards. However, under this alternative, the agency would fail to meet its general obligation to ensure that the fees for such services are established at rates that allow the agency to recoup its costs, and would unfairly transfer the costs of this program to all other applicants for benefits and services from USCIS. See OMB Circular A-25 (available at *http://www.whitehouse.gov/omb/circulars/a025/a025.html* ). USCIS data indicates that the number of Forms I-551 without an expiration date issued, minus the number of persons known to have held these cards before naturalizing, is 1.9 million. Consequently, the maximum number of aliens impacted by this rule is 1.9 million. 4 The direct cost to each applicant for replacement of a card under this program is $370 in fees ($290 for the application plus $80 for the biometrics capture fee). These costs fall exclusively upon individuals who possess cards issued before August of 1989 and which do not have an expiration date. Because these persons would not otherwise have to acquire new cards, and would not otherwise have all their biometrics captured, we believe these fees would be generated only by this new rule. Based upon these figures, this rule will cost applicants a maximum of $703 million in fees ($370 × 1.9 million). 4 As stated above, and as explained below, USCIS only anticipates that 750,000 persons will apply for a replacement card. This discussion uses the figure 1.9 million instead to reflect the maximum number of persons that may be impacted by this rule. Furthermore, each member of this group would be required to spend two hours and 55 minutes complying with this rule. USCIS estimates that each applicant will spend ten minutes reading the application Form I-90 instructions. Each applicant also will take ten minutes to complete the form and thirty-five minutes to assemble and submit the form, for a total of 55 minutes of each applicant's time. Applicants will also be required to travel to the nearest USCIS Application Support Center (ASC). While travel times and distances will vary, USCIS estimates the average round-trip to an ASC will be 20 miles, and that the average time for that trip will be an hour. It will take an average of one hour for an applicant to wait for service, and to have his or her biometrics collected. Total time for each applicant to comply with this requirement is two hours and fifty-five minutes. The Bureau of Labor Statistics reports in its 2006 national compensation survey that the average, U.S.-employed person earned $19.29 an hour (BLS Web site). In addition, the average wage of this large group should mimic the national average. Consequently, USCIS believes that $19.29 an hour is a reasonable proxy to use to value the opportunity cost of time for the applicants subject to this rule. The total cost for applicant time spent is calculated as $107 million (1.9 million persons × 2.916 hours × $19.29). Additionally, there is the cost of travel. USCIS anticipates most applicants will drive privately-owned vehicles to the ASCs. GSA's published decision of February 1, 2007, on this subject calculates the cost of operating a privately-owned vehicle as 48.5 cents a mile. (GSA Web site, reporting on findings for February 1, 2007). Therefore, USCIS calculates the transportation costs as $19 million (1.9 million persons × 48.5 cents per mile × 20 miles). Thus, if all holders of cards issued without expiration dates filed a replacement application, the total maximum cost of the program would consist of $703 million in fees, $107 million in time, and $19 million in transportation costs. The total maximum cost of compliance to this rule by 1.9 million persons is $829 million ($703 million + $107 million + $19 million). Notwithstanding, experience from the replacement program for an earlier, now-invalid version of the Permanent Resident Card (Form I-151) has shown that a portion of these applicants will apply for naturalization rather than replace their Permanent Resident Cards and thus significantly reduce the overall cost of this rule. Other holders of affected cards may be deceased, may have relinquished their United States residence, or may have previously replaced their cards for other reasons, such as the replacement of a lost or mutilated card. In addition, some potential applicants may choose not to spend time and money to replace their cards, because they do not habitually travel outside the United States. Some potential applicants, in spite of USCIS's public relations efforts, may not learn of the requirement that such cards be changed. Also, some cards may be in possession of persons who obtained them fraudulently or who have committed serious criminal offenses since obtaining their cards. USCIS theorizes that these persons may choose not to take the perceived risk of contacting DHS and of calling into question their right to be in the United States. USCIS accordingly estimates the most likely outcome of this program is that 750,000 persons issued cards without expiration dates, but not yet recorded as naturalized, will apply for replacement cards under this rule. USCIS calculates the cost of the primary estimate as $327 million ($829 million × 0.395 or 750,000 of 1.9 million maximum applicants). Based on the formulas provided above, USCIS's $327 million estimate consists of $278 million in fees associated with the Form I-90, $42 million in opportunity costs for an applicant's time, and $7 million in transportation costs for round trip transit to the nearest USCIS Application Support Center. Accounting Statement As required by OMB Circular A-4 (available at *http://www.whitehouse.gov/omb/circulars/a004/a-4.html* ), in Table 1, USCIS has prepared an accounting statement showing the classification of the expenditures associated with this economically significant rule. The table provides USCIS's primary or most likely estimate of the dollar amount of these costs expressed on an annualized basis and also includes USCIS's maximum annualized estimate at both the three percent and seven percent discount rates. The period of analysis is three years (2007, 2008, and 2009). Based on USCIS's primary or most likely estimate, the undiscounted total cost of this rule will be approximately $327 million. USCIS anticipates that the duration of the I-551 replacement card program implemented by the final rule will be three
(3)years. Consequently, when the undiscounted total cost is broken down into calendar years, this rulemaking is expected to cost $290 million in 2007, $24 million in 2008, and $13 million in 2009. Below is the expected annualized cost of this rulemaking, at both 3% and 7%, over the three year period of analysis. Enhanced security and the capabilities accompanying the storage of full fingerprint sets for subsequent retrieval constitute non-quantified benefits. *OMB #:* 1615-0082 *Agency/Program Office:* DHS/USCIS *Rule Title:* Application Process for Replacing Forms I-551 without an Expiration Date *RIN#:* 1615-AB36 Classification of Expenditures, CY 2007 Through CY 2009 [2006 Dollars] Category Primary estimate Minimum estimate Maximum estimate Source citation (RIA, preamble, etc.) BENEFITS Enhanced Border Control, More secure alien registration document Preamble Monetized benefits Annualized quantified, but un-monetized, benefits NA NA NA NA (Unquantified) benefits Enhanced Security COSTS Annualized monetized costs at 3 percent $89.07 million per year Annual monetized costs at 7 percent $99.85 million per year Annualized quantified, but un-monetized, costs NA NA NA NA Qualitative (unquantified) costs TRANSFERS Annualized monetized transfers: “on budget” NA NA NA NA From whom to whom? Annualized monetized transfers: “off-budget” NA NA NA NA From whom to whom? Category Effects Source citation (RIA, preamble, etc.) Effects on State, local, and/or Tribal governments NA NA NA NA Effects on small businesses NA NA NA NA Effects on wages NA NA NA NA Effects on growth NA NA NA NA E. Executive Order 13132 This proposed rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. F. Executive Order 12988 Civil Justice Reform This proposed rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988. G. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995, Public Law 104-13, all departments are required to submit to the Office of Management and Budget (OMB), for review and approval, any reporting requirements inherent in a rule. This rule includes an approved information collection. The OMB control number for this collection is 1615-0082 and is contained in 8 CFR 299.5. However, this rule will increase the number of respondents and the burden hours, and public costs. Accordingly, when this rule is finalized, USCIS will submit to OMB for approval an 83-C Change Worksheet that reflects any change in Form I-90 filings and any related changes to the public costs associated with this collection. List of Subjects 8 CFR Part 1 Administrative practice and procedure, Immigration. 8 CFR Part 264 Reporting and recordkeeping requirements. 8 CFR Part 299 Immigration, Reporting and recordkeeping requirements. PART 1—DEFINITIONS 1. The authority citation for part 1 continues to read as follows: Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 5 U.S.C. 301; Public Law 107-296, 116 Stat. 2135 (6 U.S.C. 1 *et seq.* ). 2. Section 1.1(aa) is added to read as follows: § 1.1 Definitions.
(aa)The term *Form I-551* means a Permanent Resident Card, or an Alien Registration Receipt Card, issued on a Form I-551 with an expiration date. Unless otherwise specifically provided in this chapter I, a Form I-551 is not valid for any use under this chapter I unless it bears an expiration date and is unexpired. PART 264—REGISTRATION AND FINGERPRINTING OF ALIENS IN THE UNITED STATES 3. The authority citation for part 264 continues to read as follows: Authority: 8 U.S.C. 1103, 1201, 1303-1305; 8 CFR part 2. 4. Section 264.5 is amended by: a. Revising paragraph (c)(1); and by b. Revising paragraph (e). The revisions read as follows: § 264.5 Application for a replacement Permanent Resident Card.
(c)* * *
(1)A permanent resident must apply on Form I-90 to replace a prior edition of the Alien Registration Receipt Card issued on Form AR-3, AR-103, or I-151. A permanent resident must apply between October 22, 2007 and February 19, 2008 on Form I-90 to replace a prior edition of Form I-551 without an expiration date. A permanent resident who fails to apply during this 120-day application period still must apply to replace a Form I-551 without an expiration date but might not be issued a replacement Form I-551 before the termination of the validity of all Forms I-551 without an expiration date. USCIS will announce the termination date of the validity of Forms I-551 without an expiration date in a Notice published in the **Federal Register** . Forms I-551 without an expiration date will remain valid until such termination date.
(e)*Application process* —(1) *Filing requirements.* Form I-90 must be filed in accordance with the instructions on the form.
(2)*Biometrics capture.* If the application is properly filed, the applicant will receive a notice to appear in person at a USCIS facility for biometrics capture. In the case of an applicant who is physically incapable, because of the applicant's confinement due to advanced age or physical infirmity, of appearing at a USCIS facility for biometrics capture, USCIS may excuse the applicant's personal appearance at a USCIS facility and provide an appropriate alternative means for obtaining the applicant's photograph or other biometrics information.
(3)*Interview.* An applicant may be required to appear in person before an immigration or consular officer and be interviewed under oath in connection with this application. PART 299—IMMIGRATION FORMS 5. The authority citation for part 299 continues to read as follows: Authority: 8 U.S.C. 1101 and note, 1103; 8 CFR part 2. 6. Section 299.1 is amended in the table by revising the entry for Form “I-90”, to read as follows: § 299.1 Prescribed forms. Form No. Edition date Title and description * * * * * * * I-90 03/31/05 Application to Replace Permanent Resident Card * * * * * * * § 299.5 Display of control numbers. 7. Section 299.5 is amended in the table by revising the entry for Form “I-90”, to read as follows: Form No. Form title Currently assigned OMB control No. * * * * * * * I-90 Application to Replace Permanent Resident Card 1615-0082 * * * * * * * Michael Chertoff, Secretary. [FR Doc. E7-16311 Filed 8-21-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-200-28869; Airspace Docket No. 07-ACE-11] Proposed Establishment of Class E5 Airspace; Tarkio, MO AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking. SUMMARY: This action proposes to establish Class E airspace at Gould Peterson Municipal Airport, Tarkio, MO. The development of an Area Navigation
(RNAV)Standard Instrument Approach Procedure
(SIAP)to serve flights operating into the Gould Peterson Municipal Airport during Instrumental Flight Rules
(IFR)conditions makes this action necessary. Controlled airspace extending upward from 700 feet Above Ground Level
(AGL)is needed to contain aircraft executing an approach. The area would be depicted on aeronautical charts for pilot reference. DATES: Comments must be received on or before October 1, 2007. ADDRESSES: Send comments on this proposal to the Docket Management System, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You must identify the docket number FAA-2007-28869/Airspace Docket No. 07-ACE-11, at the beginning of your comments. You may also submit comments on the Internet at *http://dms.dot.gov.* You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527) is on the ground floor of the building at the above address. FOR FURTHER INFORMATION CONTACT: Grant Nichols, System Support, DOT Regional Headquarters Building, Federal Aviation Administration, 901 Locust, Kansas City, MO 64106; telephone:
(816)329-2522. 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 and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2007-28869/Airspace Docket No. 07-ACE-11.” The postcard will be date/time stamped and returned to the commenter. 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 Superintendent of Documents' Web page at *http://www.access.gpo.gov/nara.* Additionally, any person may obtain a copy of this notice by submitting a request to the Federal Aviation Administration (FAA), Office of Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW., Washington, DC 20591, or by calling
(202)267-8793. Communications must identify both docket numbers for this notice. Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking
(202)267-9677, to request 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 to amend Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace at Tarkio, MO. Controlled airspace is necessary to accommodate aircraft using the new RNAV(GPS) IAP at Gould Peterson Municipal Airport. This action would enhance the safety and management of aircraft operations at Gould Peterson Municipal Airport, Tarkio, MO. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in Paragraph 6005 of FAA Order 7400.9P, dated September 1, 2006, and effective September 16, 2006, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in the 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. It, therefore,
(1)is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (Air). The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration 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. ACE E5 Tarkio, MO [New] Gould Peterson Municipal Airport, Tarkio, MO (Lat. 40°26′45″ N., long. 95°21′46″ W.) That airspace extending upward from 700 feet above the surface within a 7.6-mile radius of Gould Peterson Municipal Airport, Tarkio, MO. Issued in Fort Worth, Texas, on August 7, 2007. Donald R. Smith, Manager, System Support Group, ATO Central Service Center. [FR Doc. 07-4107 Filed 8-21-07; 8:45 am]
Connectionstraces to 55
Traces to 55 documents
CFR
- Glycerol ester of rosin.§ 172.735
- Chewing gum base.§ 172.615
- Pressure-sensitive adhesives.§ 175.125
- Petitions.§ 171.1
- Delegation of rulemaking authority.§ 1.05-1
- Patent application and reexamination processing fees.§ 1.17
- National application filing, search, and examination fees.§ 1.16
- Patent post allowance (including issue) fees.§ 1.18
- Post-issuance fees.§ 1.20
- National stage fees.§ 1.492
- Fees.§ 41.20
- Definitions.§ 42.63
- Applicability.§ 71.1
U.S. Code
- Definitions; generally§ 321
- Rule making§ 553
- Avoidance of duplicative or unnecessary analyses§ 605
- Establishment, functions, and activities§ 272
- Transferred§ 1226
- Transferred§ 191
- Patent fees; patent and trademark search systems§ 41
- Purposes§ 3501
- Powers and duties§ 2
- Application§ 111
- Issue of patent§ 151
- Time for prosecuting application§ 133
- Benefit of earlier filing date; right of priority§ 119
- National stage: Commencement§ 371
- Appeal to the Patent Trial and Appeal Board§ 134
- Definitions§ 601
- SHORT TITLE.§ 801
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Congressional findings and declaration of purpose§ 7401
- Tolerances and exemptions for pesticide chemical residues§ 346a
- Purposes of chapter; Federal Communications Commission created§ 151
- Definitions§ 101
- Departmental regulations§ 301
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Records maintained on individuals§ 552a
- Forms for registration and fingerprinting§ 1304
- Registration of aliens§ 1302
- Machine-readable, tamper-resistant entry and exit documents§ 1732
- Penalties§ 1306
- Unlawful employment of aliens§ 1324a
- Definitions§ 1101
- Powers and duties of the Secretary, the Under Secretary, and the Attorney General§ 1103
- SHORT TITLE.§ 1
- Federal Aviation Administration§ 106
register
public-private-law
61 references not yet in our index
- 21 CFR 172
- 33 CFR 117
- 33 CFR 117.483
- 33 CFR 165
- 5 USC 601-612
- Pub. L. 104-121
- 44 USC 3501-3520
- 2 USC 1531-1538
- 42 USC 4321-4370f
- Pub. L. 107-295
- Pub. L. 108-447
- Pub. L. 103-465
- 37 CFR 1
- 37 CFR 41
- 40 CFR 52
- 40 CFR 50
- Pub. L. 104-4
- 40 CFR 180
- 40 CFR 178
- 40 CFR 2
- 40 CFR 180.517
- 40 CFR 166
- Pub. L. 104-113
- 40 CFR 180.510
- 47 CFR 36
- 47 CFR 54
- Pub. L. 104-104
- 6 CFR 5
- Pub. L. 107-296
- 116 Stat. 2135
- 8 CFR 264.1(b)
- 8 CFR 274
- 8 CFR 211.1(a)(2)
- 8 CFR 264.5(a)
- Pub. L. 107-173
- 116 Stat. 543
- Pub. L. 108-299
- 118 Stat. 1100
- 8 CFR 264.5(c)(1)
- 8 CFR 103.7(c)
+ 21 more
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