Unknown. Interim rule and request for comments

44,834 words·~204 min read·/register/2006/09/13/06-7526

A 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-2006-09-13.xml --- 71 177 Wednesday, September 13, 2006 Contents Agricultural Agricultural Marketing Service PROPOSED RULES Milk marketing orders: Appalachian and Southeast, 54118-54134 06-7497 Central, 54152-54170 06-7498 Mideast, 54172-54186 06-7495 Upper Midwest, 54136-54149 06-7496 Agriculture Agriculture Department See Agricultural Marketing Service See Animal and Plant Health Inspection Service See Food and Nutrition Service See Forest Service Air Force Air Force Department NOTICES Environmental statements; record of decision:

Avon Park Air Force Range, FL; air-to-ground training, 54031 E6-15183 Animal Animal and Plant Health Inspection Service RULES Plant-related quarantine, domestic: Mediterranean fruit fly, 53963-53964 E6-15213 Census Census Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 54020-54021 E6-15116 Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 54086-54087 E6-15151 E6-15184 Commerce Commerce Department See Census Bureau See Industry and Security Bureau See International Trade Administration See National Oceanic and Atmospheric Administration See Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 54019-54020 E6-15122 Defense Defense Department See Air Force Department Education Education Department RULES Elementary and secondary education:

Disadvantaged children; academic achievement improvement, 54188-54194 06-7646 NOTICES Agency information collection activities; proposals, submissions, and approvals, 54031-54032 E6-15115 Employment Employment and Training Administration NOTICES Adjustment assistance; applications, determinations, etc.: C-Tech Industries Inc., 54093 E6-15080 Demers Leather Sales et al., 54094-54096 E6-15081 Fibre Metal Products Co. et al., 54096-54097 E6-15106 Kirin Cutting Service, Inc., 54097 E6-15078 Mountain Surf, Inc., 54097 E6-15079 Nypro-Kentucky, 54097 E6-15110 Oneida Ltd., 54097-54098 E6-15077 Energy Energy Department See Federal Energy Regulatory Commission EPA Environmental Protection Agency RULES Air programs; approval and promulgation;

State plans for designated facilities and pollutants: Vermont, 53972-53974 E6-15198 Hazardous waste program authorizations: Alabama, 53989-53991 E6-15201 Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Difenoconazole, 53979-53984 E6-15090 Epoxiconazole, 53984-53989 E6-14994 Eucalyptus oil, 53974-53979 E6-14995 PROPOSED RULES Air programs; approval and promulgation; State plans for designated facilities and pollutants: Vermont, 54007 E6-15199 Hazardous waste program authorizations:

Alabama, 54007-54008 E6-15203 NOTICES Meetings: Association of American Pesticide Control Officials State FIFRA Issues Research and Evaluation Group, 54054 E6-14990 Gulf of Mexico Program Policy Review Board, 54054-54055 E6-15205 Tribal Pesticide Program Council, 54055 E6-14991 Pesticide, food, and feed additive petitions: Consumer Specialty Products Association, 54055-54057 E6-15204 Interregional Research Project (No. 4), 54057-54061 E6-14989 E6-14992 E6-15083 Toxic and hazardous substances control:

New chemicals; receipt and status information, 54061-54068 E6-15091 E6-15092 Executive Executive Office of the President See Presidential Documents Export Export-Import Bank NOTICES Agency information collection activities; proposals, submissions, and approvals, 54068-54070 06-7615 FCC Federal Communications Commission RULES Radio frequency devices: Digital television receiver tuner requirements, 53991-53993 E6-15067 PROPOSED RULES Common carrier services: Individuals with hearing and speech disabilities; telecommunications relay services and speech-to-speech services, 54009-54017 E6-14901 Missoula Intercarrier Compensation Reform Plan, 54008-54009 E6-15196 NOTICES Agency information collection activities; proposals, submissions, and approvals, 54071-54075 E6-15068 E6-15071 E6-15195 Federal Energy Federal Energy Regulatory Commission RULES Electric utilities (Federal Power Act):

Generator interconnection agreements and procedures; standardization Correction, 53965-53966 E6-15126 NOTICES Complaints filed: Indeck-Elwood, LLC, et al., 54047 E6-15174 Electric rate and corporate regulation combined filings, 54047-54051 E6-15137 E6-15149 Environmental statements; availability, etc.: Wolf River Hydro LP, 54051 E6-15148 Hydroelectric applications, 54051-54053 E6-15141 E6-15178 Meetings: Hydroelectric infrastructure conference, 54053 E6-15182 Preventing undue discrimination and preference in transmission service; technical conference, 54053-54054 E6-15179 *Applications, hearings, determinations, etc.:* Algonquin Gas Transmission LLC, et al., 54032-54033 E6-15180 ALLETE, Inc., et al., 54033-54034 E6-15142 American Electric Power Service Corp., 54034 E6-15173 ANR Pipeline Co., 54034-54035 E6-15140 E6-15161 Chandeleur Pipe Line Co., 54035 E6-15158 Colorado Interstate Gas Co., 54035-54036 E6-15155 E6-15162 Columbia Gas Transmission Corp., 54036 E6-15181 Devon Power LLC, 54036-54037 E6-15176 East Tennessee Natural Gas, LLC, 54037 E6-15147 El Paso Natural Gas Co., 54037 E6-15156 Escondido, CA, 54037-54038 E6-15153 Florida Gas Transmission Co., LLC, 54038 E6-15163 Gas Transmission Northwest Corp., 54038 E6-15152 Gulf South Pipeline Co., LP, 54038-54039 E6-15159 LSP Morro Bay, LLC, et al., 54039-54040 E6-15172 Maritimes & Northeast Pipeline, L.L.C., 54040 E6-15145 Midwestern Gas Transmission Co., 54040 E6-15166 MIGC, Inc., et al., 54040-54041 E6-15171 National Fuel Gas Supply Corp., 54041 E6-15164 Northern Natural Gas Co., 54041-54043 E6-15143 E6-15157 E6-15169 PPL EnergyPlus, LLC, et al., 54043-54044 E6-15175 Questar Pipeline Co., 54044 E6-15160 Rockies Express Pipeline LLC, 54044 E6-15154 Sabine Pipe Line LLC, 54044-54045 E6-15165 Southwest Transmission Cooperative, Inc., 54045 E6-15177 Texas Eastern Transmission, LP, 54045-54046 E6-15144 E6-15170 TransColorado Gas Transmission Co., 54046 E6-15168 Viking Gas Transmission Co., 54046-54047 E6-15167 FMC Federal Maritime Commission NOTICES Agreements filed, etc., 54075 E6-15210 Federal Reserve Federal Reserve System NOTICES Agency information collection activities; proposals, submissions, and approvals, 54075-54078 E6-15123 Banks and bank holding companies:

Permissible nonbanking activities, 54078-54079 E6-15193 Meetings; Sunshine Act, 54079 06-7643 FTC Federal Trade Commission NOTICES Premerger notification waiting periods; early terminations, 54079-54081 06-7610 Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc.: Long Island National Wildlife Refuge Complex, NY, 54089 E6-15150 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Chlortetracycline, 53966 E6-15103 NOTICES Grants and cooperative agreements; availability, etc.:

Shellfish and Seafood Safety Assistance Project, 54087-54088 E6-15102 Food Food and Nutrition Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 54018-54019 06-7647 Foreign Foreign Assets Control Office NOTICES Sanctions; blocked persons, specially designated nationals, terrorists, narcotics traffickers, and foreign terrorist organizations: Individuals and entities subject to various economic sanctions programs; list, 54113-54114 E6-15206 Forest Forest Service NOTICES Meetings:

Resource Advisory Committees— Trinity County, 54019 06-7606 Government Government Ethics Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 54081-54086 E6-15129 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration Housing Housing and Urban Development Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 54088-54089 E6-15104 Industry Industry and Security Bureau RULES Export administration regulations:

Mayrow General Trading and related entities; general order Additional entities; correction, 53964-53965 E6-15135 Interior Interior Department See Fish and Wildlife Service See Land Management Bureau IRS Internal Revenue Service RULES Excise taxes: Pension excise taxes; Health Saving Accounts; employer comparable contributions Correction, 53966-53967 E6-15125 Income taxes: Attained age of the insured under (section 7702), 53967-53971 E6-15117 PROPOSED RULES Income Taxes: Essential governmental function definition and limitation to activities customarily performed by States and local governments; definition Correction, 54005 E6-15119 Repeal of tax interest on nonresident alien individuals and foreign corporations received from certain portfolio debt investments; public hearing Public hearing canceled, 54005 E6-15127 Procedure and administration:

Enrollment; user fees Correction, E6-15118 54005-54006 E6-15121 NOTICES Meetings: Taxpayer Advocacy Panels, 54114-54115 E6-15120 E6-15124 International International Trade Administration NOTICES Antidumping: Polyethylene retail carrier bags from— China, 54021-54029 E6-15214 Justice Justice Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 54091-54092 E6-15209 Meetings: Violence Against Women National Advisory Committee, 54092-54093 E6-15208 Pollution control; consent judgments:

United Park City Mines Co., et al., 06-7617 54093 06-7618 Labor Labor Department See Employment and Training Administration Land Land Management Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 54089-54090 06-7608 06-7609 Alaska Native claims selection: MTNT, Ltd., 54090-54091 E6-15107 White Mountain Native Corp., 54091 E6-15108 NOAA National Oceanic and Atmospheric Administration NOTICES Exempted fishing permit applications, determinations, etc., 54029-54030 E6-15192 Meetings:

U.S. Atlantic Swordfish Fishery, 54030-54031 E6-15197 National Science National Science Foundation NOTICES Meetings: U.S. Chief Financial Officer Council Grants Policy Committee, 54098-54099 06-7614 Nuclear Nuclear Regulatory Commission NOTICES Environmental statements; availability, etc.: Army Department, Aberdeen Test Center Facility, MD, 54099-54100 E6-15132 Entergy Nuclear Operations, Inc., 54100-54101 E6-15133 Overseas Overseas Private Investment Corporation NOTICES Meetings;

Sunshine Act, 54101 06-7653 Patent Patent and Trademark Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 54031 E6-15138 Postal Postal Service RULES Practice and procedure: False representation and lottery cases; nonmailability and disposition of mail withheld from delivery; litigation responsibility, 53971-53972 E6-15113 PROPOSED RULES Domestic Mail Manual: Priority mail to or from “969” ZIP Codes; custom forms, 54006 E6-15112 Presidential Presidential Documents PROCLAMATIONS *Special observances:* National Historically Black Colleges and Universities Week (Proc. 8048), 53961-53962 E6-15292 SEC Securities and Exchange Commission NOTICES Securities:

Suspension of trading— Southwestern Medical Solutions, Inc., 54102 06-7654 Self-Regulatory Organizations: New York Stock Exchange LLC, 54102-54104 E6-15187 Self-regulatory organizations; proposed rule changes: Depository Trust Co., 54104-54105 E6-15191 National Association of Securities Dealers, Inc., 54105-54107 E6-15186 Options Clearing Corp., 54107-54108 E6-15189 SBA Small Business Administration NOTICES Disaster loan areas: New Jersey, 54108 E6-15211 Social Social Security Administration PROPOSED RULES Organization and procedures:

Official records and information; privacy and disclosure, 53994-54000 E6-15101 State State Department PROPOSED RULES Intercountry Adoption Act of 2000: Hague Convention— Emigrating children; convention and non-convention adoptions; reporting requirements, 54001-54005 06-7526 NOTICES Arms Export Control Act: Commercial export licenses; congressional notifications, 54108-54113 E6-15190 Meetings: Shipping Coordinating Committee, 54113 E6-15256 Treasury Treasury Department See Foreign Assets Control Office See Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 54113 E6-15207 Veterans Veterans Affairs Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 54115 E6-15098 Separate Parts In This Issue Part II Agriculture Department, Agricultural Marketing Service, 54118-54134 06-7497 Part III Agriculture Department, Agricultural Marketing Service, 54136-54149 06-7496 Part IV Agriculture Department, Agricultural Marketing Service, 54152-54170 06-7498 Part V Agriculture Department, Agricultural Marketing Service, 54172-54186 06-7495 Part VI Education Department, 54188-54194 06-7646 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. 71 177 Wednesday, September 13, 2006 Rules and Regulations DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 301 [Docket No. APHIS-2005-0116] Mediterranean Fruit Fly; Remove Portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, From the List of Quarantined Areas AGENCY:

Animal and Plant Health Inspection Service, USDA. ACTION: Interim rule and request for comments. SUMMARY: We are amending the Mediterranean fruit fly regulations by removing portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, from the list of quarantined areas and by removing restrictions on the interstate movement of regulated articles from those areas. This action is necessary to relieve restrictions that are no longer needed to prevent the spread of Mediterranean fruit fly into noninfested areas of the United States.

We have determined that the Mediterranean fruit fly has been eradicated from these portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, and that the quarantine and restrictions are no longer necessary. These portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, were the last remaining areas in California quarantined for Mediterranean fruit fly. Therefore, as a result of this action, there are no longer any areas in the continental United States quarantined for the Mediterranean fruit fly.

DATES: This interim rule was effective September 7, 2006. We will consider all comments that we receive on or before November 13, 2006. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov,* select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2005-0116 to submit or view public comments and to view supporting and related materials available electronically.

Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2005-0116, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No.

APHIS-2005-0116. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call

(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov.* FOR FURTHER INFORMATION CONTACT: Mr. Wayne D. Burnett, National Fruit Fly Program Manager, PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1236;

(301)734-4387. SUPPLEMENTARY INFORMATION: Background The Mediterranean fruit fly (Medfly, *Ceratitis capitata* [Wiedemann]) is one of the world's most destructive pests of numerous fruits and vegetables. The Medfly can cause serious economic losses. Heavy infestations can cause complete loss of crops, and losses of 25 to 50 percent are not uncommon. The short life cycle of this pest permits the rapid development of serious outbreaks. The Mediterranean fruit fly regulations, contained in 7 CFR 301.78 through 301.78-10 (referred to below as the regulations), restrict the interstate movement of regulated articles from quarantined areas to prevent the spread of Medfly to noninfested areas of the United States. The regulations also designate soil and a large number of fruits, nuts, vegetables, and berries as regulated articles. In an interim rule effective on February 7, 2006, and published in the **Federal Register** on February 13, 2006 (71 FR 7393-7395, Docket No. APHIS-2005-0116), we quarantined portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, and restricted the interstate movement of regulated articles from the quarantined areas. Based on trapping surveys conducted by inspectors of California State and county agencies and by inspectors of the Animal and Plant Health Inspection Service, we have determined that Medfly has been eradicated from the quarantined portions of these counties. The last finding of Medfly in the Los Angeles and San Bernardino Counties, CA, quarantined areas was December 13, 2005, and the last finding of Medfly in the Santa Clara County, CA, quarantined area was October 9, 2005. Since then, no evidence of Medfly infestation has been found in these areas. Based on our experience, we have determined that sufficient time has passed without finding additional flies or other evidence of infestation to conclude that Medfly no longer exists in Los Angeles, San Bernardino, and Santa Clara Counties, CA. Therefore, we are removing the counties from the list of quarantined areas in § 301.78-3(c). With the removal of Los Angeles, San Bernardino, and Santa Clara Counties, CA, from that list, there are no longer any areas in the continental United States quarantined for Medfly. Immediate Action Immediate action is warranted to relieve restrictions that are no longer necessary. Portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, were quarantined due to the possibility that the Medfly could be spread from those areas to noninfested areas of the United States. Since we have concluded that Medfly no longer exists in those areas, immediate action is warranted to remove the quarantine on Los Angeles, San Bernardino, and Santa Clara Counties, CA, and to relieve the restrictions on the interstate movement of regulated articles from those areas. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the **Federal Register** . We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the **Federal Register.** The document will include a discussion of any comments we receive and any amendments we are making to the rule. Executive Order 12866 and Regulatory Flexibility Act This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866. This action amends the Medfly regulations by removing Los Angeles, San Bernardino, and Santa Clara Counties, CA, from the list of quarantined areas. County records indicated there are approximately 297 small entities that may be affected by the lifting of the quarantine in this interim rule. These include 127 yard maintenance firms, 110 fruit sellers, 22 nurseries, 15 growers, 4 distributors, 4 haulers, 3 certified farmers' market, 3 processors, 2 harvesters, 2 packers, 2 recyclers, 1 food bank, 1 producer, and 1 swapmeet. These 297 entities comprise less than 1 percent of the total number of similar entities operating in the State of California. We expect that the effect of this interim rule on the small entities referred to above will be minimal. Small entities located within the quarantined area that sell regulated articles do so primarily for local intrastate, not interstate, movement, so the effect, if any, of this rule on these entities appears likely to be minimal. In addition, the effect on any small entities that may move regulated articles interstate has been minimized during the quarantine period by the availability of various treatments that allow these small entities, in most cases, to move regulated articles interstate with very little additional cost. Thus, just as the previous interim rule establishing the quarantined area in portions of Los Angeles, San Bernardino, and Santa Clara Counties, CA, had little effect on the small entities in the area, the lifting of the quarantine in the current interim rule will also have little effect. Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12988 This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule:

(1)Preempts all State and local laws and regulations that are inconsistent with this rule;

(2)has no retroactive effect; and

(3)does not require administrative proceedings before parties may file suit in court challenging this rule. Paperwork Reduction Act This interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). List of Subjects in 7 CFR Part 301 Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation. Accordingly, we are amending 7 CFR part 301 as follows: PART 301—DOMESTIC QUARANTINE NOTICES 1. The authority citation for part 301 continues to read as follows: Authority: 7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, and 371.3. Section 301.75-15 issued under Sec. 204, Title II, Public Law 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 (7 U.S.C. 1421 note). 2. In § 301.78-3, paragraph

(c)is revised to read as follows: § 301.78-3 Quarantined areas.

(c)The areas described below are designated as quarantined areas: There are no areas in the continental United States quarantined for the Mediterranean fruit fly. Done in Washington, DC, this 7th day of September 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6-15213 Filed 9-12-06; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 736 [Docket No. 060818222-6222-01] RIN 0694-AD83 Amendment to General Order No. 3: Addition of Certain Entities; Correction AGENCY: Bureau of Industry and Security, Commerce. ACTION: Correcting amendment. SUMMARY: The Bureau of Industry and Security

(BIS)published a final rule in the **Federal Register** on Wednesday, September 6, 2006 (71 FR 52426) that amended a general order published on June 5, 2006 in the **Federal Register** to add nine additional entities related to Mayrow General Trading. The September 6, 2006, final rule contained an error in the amendatory language for paragraph (a)(1). This document corrects that error by revising that paragraph of the general order. DATES: *Effective Date:* This rule is effective September 6, 2006. FOR FURTHER INFORMATION CONTACT: Michael D. Turner, Director, Office of Export Enforcement, Bureau of Industry and Security, Department of Commerce, P.O. Box 273, Washington, DC 20044; Phone:

(202)482-1208, x3; E-mail: *rpd2@bis.doc.gov* ; Fax:

(202)482-0964. SUPPLEMENTARY INFORMATION: Background This document corrects an inadvertent error in the final rule that was published by the Bureau of Industry and Security

(BIS)on September 6, 2006 (71 FR 52426). In the September 6, 2006, final rule, the amendatory instruction for General Order No. 3 to Supplement No. 1 to part 736, paragraph (a)(1) did not specify that the entire paragraph (a)(1) was being revised. This document corrects General Order No. 3 to Supplement No. 1 to part 736, by revising paragraph (a)(1). Consistent with section 6 of the Export Administration Act of 1979, as amended (50 U.S.C. app. 2401-2420)

(2000)(the “Act”), a foreign policy report was submitted to Congress on August 29, 2006, notifying Congress of the imposition of a control in the form of a licensing requirement for exports and reexports of all items subject to the EAR destined to the nine additional entities related to Mayrow General Trading that were added to General Order No. 3 with the September 6, 2006, final rule. Since August 21, 2001, the Act has been in lapse and the President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp. 783 (2002)), as extended most recently by the Notice of August 3, 2006 (71 FR 44551 (August 7, 2006)), has continued the EAR in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701-1706 (2000)) (“IEEPA”). BIS continues to carry out the provisions of the Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222. Rulemaking Requirements 1. This rule has been determined to be not significant for purposes of Executive Order 12866. 2. Notwithstanding any other provision of law, no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid Office of Management and Budget

(OMB)Control Number. This regulation involves collections previously approved by the OMB under control numbers 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Miscellaneous and recordkeeping activities account for 12 minutes per submission. Total burden hours associated with the Paperwork Reduction Act and Office and Management and Budget control number 0694-0088 are expected to increase slightly as a result of this rule. Send comments regarding these burden estimates or any other aspect of this collection of information, including suggestions for reducing the burden, to David Rostker, OMB Desk Officer, by e-mail at *david_rostker@omb.eop.gov* or by fax to

(202)395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, P.O. Box 273, Washington, DC 20044, e-mail: *publiccomments@bis.doc.gov.* 3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132. 4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States. ( *See* 5 U.S.C. 553(a)(1)) Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 *et seq.* , are not applicable. List of Subjects in 15 CFR Part 736 Exports, Foreign trade. Accordingly, part 736 of the Export Administration Regulations (15 CFR part 736) is corrected by making the following correcting amendment: PART 736—[CORRECTED] 1. The authority citation for 15 CFR part 736 is revised to read as follows: Authority: 50 U.S.C. app. 2401 *et seq.* ; 50 U.S.C. 1701 *et seq.* ; 22 U.S.C. 2151 (note), Public Law 108-175; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp. p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, May 13, 2004; Notice of October 25, 2005, 70 FR 62027 (October 27, 2005); Notice of August 3, 2006, 71 FR 44551 (August 7, 2006). 2. General Order 3 to Supplement No. 1 to part 736, paragraph (a)(1) is correctly revised to read as follows: Supplement No. 1 to Part 736—General Orders

(a)*License requirements.*

(1)Effective June 5, 2006, a license is required to export or reexport any item subject to the EAR to Mayrow General Trading or entities related, as follows: Micatic General Trading; Majidco Micro Electronics; Atlinx Electronics; Micro Middle East Electronics; Narinco; Farrokh Nia Yaghmaei, a.k.a., Farrokh Nia Yaghmayi; and H. Ghasir. Mayrow General Trading and all entities related described in paragraph (a)(1) are located in Dubai, United Arab Emirates. This license requirement applies with respect to any transaction in which any of the above-named entities will act as purchaser, intermediate consignee, ultimate consignee, or end-user of the items. Eileen Albanese, Director, Office of Exporter Services. [FR Doc. E6-15135 Filed 9-12-06; 8:45 am] BILLING CODE 3510-33-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 35 [Docket No. RM02-12-002] Standardization of Small Generator Interconnection Agreements and Procedures AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Order on clarification; correction. SUMMARY: This document corrects an error in an Order on Clarification that the Federal Energy Regulatory Commission published in the **Federal Register** on July 27, 2006. The Order on Clarification erroneously omitted text from two sections within the appendices of the document. DATES: *Effective Date:* August 28, 2006. FOR FURTHER INFORMATION CONTACT: Michael G. Henry (Legal Information), Office of the General Counsel, Federal Energy Regulatory Commission at

(202)502-8532. SUPPLEMENTARY INFORMATION: In FR Document E6-11989, published July 27, 2006 (71 FR 42587) make the following correction to appendices 2 and 3 of the document: Appendix 2: Revised System Impact Study Agreement and Appendix 3: Revised Facilities Study Agreement [Corrected] On page 42591, column 2, section “21.0 *Reservation of Rights* and on page 42592, column 3, section “19.0 *Reservation of Rights,* the language is corrected to read as follows for both of these sections: “ *Reservation of Rights:* The Transmission Provider shall have the right to make a unilateral filing with FERC to modify this Agreement with respect to any rates, terms and conditions, charges, classifications of service, rule or regulation under section 205 of any other applicable provision of the Federal Energy Power Act and FERC rules and regulations thereunder, and the Interconnection Customer shall have the right to make a unilateral filing with FERC to modify this Agreement under any applicable provision of the Federal Power Act and FERC's rules and regulations; provided that each party shall have the right to protest any such filing by the other Party and to participate fully in any proceeding before FERC in which such modifications may be considered. Nothing in this Agreement shall limit the rights of the parties or of FERC under sections 205 or 206 of the Federal Power Act and FERC's rules and regulations, except to the extent that the parties otherwise agree as provided herein.” Magalie R. Salas, Secretary. [FR Doc. E6-15126 Filed 9-12-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Chlortetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule, technical amendment. SUMMARY: The Food and Drug Administration

(FDA)is amending the animal drug regulations to reflect approval of a supplemental new animal drug application

(NADA)filed by Alpharma Inc. The supplemental NADA provides for use of an approved Type A medicated article containing chlortetracycline to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle. DATES: This rule is effective September 13, 2006. FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail: *eric.dubbin@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024, filed NADA 48-761 for use of AUREOMYCIN 90 Granular (chlortetracycline) Type A medicated article to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle as an aid in the control of active infection of anaplasmosis caused by *Anaplasma marginale* susceptible to chlortetracycline. The supplemental NADA is approved as of July 28, 2006, and the regulations are amended in 21 CFR 558.128 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 2. In § 558.128, redesignate paragraph (e)(6) as paragraph (e)(7); and add new paragraph (e)(6) to read as follows: § 558.128 Chlortetracycline.

(e)* * *

(6)It is used as a free-choice, loose mineral Type C feed as follows:

(i)*Specifications* . Ingredient Percent International Feed No. Dicalcium Phosphate 46.20 6-26-335 Sodium Chloride

(Salt)15.00 6-04-152 Magnesium Oxide 10.67 6-02-756 Cottonseed Meal 10.00 5-01-625 Trace Mineral/Vitamin Premix 1 3.80 Calcium Carbonate 3.50 6-01-069 Dried Cane Molasses 3.00 4-04-695 Potassium Chloride 2.00 6-03-755 Mineral Oil 2.00 8-03-123 Iron Oxide 0.50 6-02-431 Chlortetracycline Type A medicated article (90 gram/lb) 3.33 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide

(EDDI)should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(ii)*Amount* . 6,000 grams per ton.

(iii)*Indications for use* . Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by *Anaplasma marginale* susceptible to chlortetracycline.

(iv)*Limitations* . Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per head per day.

(v)*Sponsor* . See No. 046573 in § 510.600(c) of this chapter. Dated: August 30, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6-15103 Filed 9-12-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 [TD 9277] RIN 1545-BE30 Employer Comparable Contributions to Health Savings Accounts Under Section 4980G; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correcting amendment. SUMMARY: This document contains a correction to final regulations (TD 9277) that were published in the ** Federal Register ** on Monday, July 31, 2006 (71 FR 43056) providing guidance regarding employer comparable contributions to Health Savings Accounts

(HSAs)under section 4980G. DATES: These corrections are effective July 31, 2006. FOR FURTHER INFORMATION CONTACT: Mireille T. Khoury,

(202)622-6080 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The correction notice that is the subject of this document is under section 4980G of the Internal Revenue Code. Need for Correction As published, the final regulations (TD 9277) contain errors that may prove to be misleading and are in need of clarification. List of Subjects in 26 CFR Part 54 Excise taxes, Pensions, Reporting and recordkeeping requirements. Correction of Publication Accordingly, 26 CFR part 54 is corrected by making the following correcting amendments: PART 54—PENSION EXCISE TAXES **Paragraph 1.** The authority citation for part 54 continues to read, in part, as follows: Authority: 26 U.S.C. 7805 * * * **Par. 2.** Section 54.4980G-0 is corrected by: 1. Revising the entries for 54.4980G-4 Q-5 and Q-11. 2. Revising the entries for 54.4980G-5 Q-3. § 54.4980G-0 Table of contents. § 54.4980G-4 Calculating comparable contributions. Q-5: Must an employer use the same contribution method as described in Q & A-2 and Q & A-4 of this section for all employees for any month during the calendar year? Q-11: If an employer makes additional contributions to the HSAs of all comparable participating employees who are eligible to make the additional contributions (HSA catch-up contributions) under section 223(b)(3), do the contributions satisfy the comparability rules? § 54.4980G-5 HSA comparability rules and cafeteria plans and waiver of excise tax. Q-3: If under the employer's cafeteria plan, employees who are eligible individuals and who participate in health assessments, disease management programs or wellness programs receive an employer contribution to an HSA and the employees have the right to elect to make pre-tax salary reduction contributions to their HSAs, are the contributions subject to the comparability rules? **Par. 3.** Section 54.4980G-4 is corrected by: 1. Revising A-2 paragraph

(c)*Example 2.* 2. Revising A-2 paragraph

(e)*Example 1.* § 54.4980G-4 Calculating comparable contributions. A-2: * * *

(c)* * * Example 2. In a calendar year, Employer J offers its employees an HDHP and contributes on a monthly pay-as-you-go basis to the HSAs of employees who are eligible individuals with coverage under Employer J's HDHP. In the calendar year, Employer J contributes $50 per month to the HSA of each employee with self-only HDHP coverage and $100 per month to the HSA of each employee with family HDHP coverage. From January 1st through March 31st of the calendar year, Employee X is an eligible individual with self-only HDHP coverage. From April 1st through December 31st of the calendar year, X is an eligible individual with family HDHP coverage. For the months of January, February and March of the calendar year, Employer J contributes $50 per month to X's HSA. For the remaining months of the calendar year, Employer J contributes $100 per month to X's HSA. Employer J's contributions to X's HSA satisfy the comparibility rules.

(d)* * *

(e)* * * Example 1. In a calendar year, Employer K offers its employees an HDHP and contributes on a look-back basis to the HSAs of employees who are eligible individuals with coverage under Employer K's HDHP. Employer K contributes $600 ($50 per month) for the calendar year to the HSA of each employee with self-only HDHP coverage and $1,200 ($100 per month) for the calendar year to the HSA of each employee with family HDHP coverage. From January 1st through June 30th of the calendar year, Employee Y is an eligible individual with family HDHP coverage. From July 1st through December 31st, Y is an eligible individual with self-only HDHP coverage. Employer K contributes $900 on a look-back basis for the calendar year to Y's HSA ($100) per month for the months of January through June and $50 per month for the months of July through December. Employer K's contributions to Y's HSA satisfy the comparability rules. Guy R. Traynor, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E6-15125 Filed 9-12-06; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9287] RIN 1545-BE53 Attained Age of the Insured Under Section 7702 AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Final regulation. SUMMARY: This document contains final regulations explaining how to determine the attained age of an insured for purposes of testing whether a contract qualifies as a life insurance contract for Federal income tax purposes. DATES: *Effective Date:* These regulations are effective September 13, 2006. *Applicability Dates:* For dates of applicability, see § 1.7702-2(f). FOR FURTHER INFORMATION CONTACT: Ann H. Logan, 202-622-3970 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background Section 7702(a) of the Internal Revenue Code

(Code)provides that, for a contract to qualify as a life insurance contract for Federal income tax purposes, the contract must be a life insurance contract under the applicable law and must either

(1)Satisfy the cash value accumulation test of section 7702(b), or

(2)both meet the guideline premium requirements of section 7702(c) and fall within the cash value corridor of section 7702(d). To determine whether a contract satisfies the cash value accumulation test, or meets the guideline premium requirements and falls within the cash value corridor, it is necessary to determine the attained age of the insured. A contract meets the cash value accumulation test of section 7702(b) if, by the terms of the contract, the cash surrender value of the contract may not at any time exceed the net single premium that would have to be paid at that time to fund future benefits under the contract. Under section 7702(e)(1)(B), the maturity date of the contract is deemed to be no earlier than the day on which the insured attains age 95, and no later than the day on which the insured attains age 100, for purposes of applying the cash value accumulation test. A contract meets the guideline premium requirements of section 7702(c) if the sum of the premiums paid under the contract does not at any time exceed the greater of the guideline single premium or the sum of the guideline level premiums as of such time. The guideline single premium is the premium that is needed at the time the policy is issued to fund the future benefits under the contract based on the following three elements enumerated in section 7702(c)(3)(B):

(i)Reasonable mortality charges that meet the requirements (if any) prescribed in regulations and that (except as provided in regulations) do not exceed the mortality charges specified in the prevailing commissioners' standard tables (as defined in section 807(d)(5)) as of the time the contract is issued;

(ii)Any reasonable charges (other than mortality charges) that (on the basis of the company's experience, if any, with respect to similar contracts) are reasonably expected to be actually paid; and

(iii)Interest at the greater of an annual effective rate of six percent or the rate or rates guaranteed on issuance of the contract. The guideline level premium is the level annual amount, payable over a period not ending before the insured attains age 95, computed on the same basis as the guideline single premium but using a minimum interest rate of four percent, rather than six percent. Like the cash value accumulation test, the guideline premium requirements are applied by deeming the maturity date of the contract to be no earlier than the day on which the insured attains age 95, and no later than the day on which the insured attains age 100. The deemed maturity date generally is the determination date set forth in the contract or the end of the mortality table (which, when section 7702 was enacted in 1984, was age 100). A contract falls within the cash value corridor if the death benefit of the contract at any time is not less than the applicable percentage of the cash surrender value. The applicable percentage is determined based on the attained age of the insured as of the beginning of the contract year, as follows: Applicable Percentage In the case of an insured with an attained age as of the beginning of the contract year of: More than: But not more than: The applicable percentage shall decrease by a ratable portion for each full year: From: To: 0 40 250 250 40 45 250 215 45 50 215 185 50 55 185 150 55 60 150 130 60 65 130 120 65 70 120 115 70 75 115 105 75 90 105 105 90 95 105 100 The Code does not define the attained age of the insured for purposes of applying the cash value corridor, the guideline premium limitations, or the computational rules of section 7702(e). The Senate Finance Committee explanation of the Deficit Reduction Act of 1984, Public Law 98-369 (98 Stat. 494), however, states that the attained age of the insured means the insured's age determined by reference to contract anniversaries (rather than the individual's actual birthdays), so long as the age assumed under the contract is within 12 months of the actual age. See S. Prt. No. 98-169, Vol. 1, at 576 (1984). Section 7702A defines a modified endowment contract

(MEC)as a contract that meets the requirements of section 7702 (that is, a contract that is a life insurance contract), but that fails to meet the 7-pay test set forth in section 7702A(b). A contract fails to meet the 7-pay test if the accumulated amount paid under the contract at any time during the first 7 contract years exceeds the sum of the net level premiums that would have been paid on or before that time if the contract provided for paid-up future benefits after the payment of 7 level annual premiums. Section 7702A(c)(1)(B) provides that, for purposes of this test, the computational rules of section 7702(e) generally apply, including the contract's deemed maturity no earlier than the day on which the insured attains age 95, and no later than the day on which the insured attains age 100. In sum, the attained age of an insured under a contract that is a life insurance contract under the applicable law must be determined to test whether the contract complies with the guideline premium requirements of section 7702(c), the cash value corridor of section 7702(d), and (by reason of the computational rules of section 7702(e)) the cash value accumulation test of section 7702(b) and the 7-pay test of section 7702A(b), as applicable. On May 24, 2005, the IRS and Treasury Department published a notice of proposed rulemaking (REG-168892-03), (2005-25 I.R.B. 1293, June 20, 2005) in the **Federal Register** (70 FR 29671) (the proposed regulations). The proposed regulations provide guidance on how to determine the attained age of an individual insured under a contract that is a life insurance contract under the applicable law, for purposes of testing whether the contract qualifies as a life insurance contract under section 7702 and is a modified endowment contract under section 7702A. Under the proposed regulations, the attained age of the insured is either

(i)The insured's age determined by reference to the individual's actual birthday as of the date of determination (actual age) or

(i)The insured's age determined by reference to the individual's actual birthday as of the date of determination (actual age), or

(ii)the insured's age determined by reference to contract anniversary (rather than the individual's actual birthday), so long as the age assumed under the contract (contract age) is within 12 months of the actual age. The proposed regulations do not, however, define the attained age to be used if there is an increase in death benefits between policy anniversary dates. Specifically, should the attained age as of the beginning of the contract year continue to be used at the time of the benefit increase, even if the date of change is closer to the next contract anniversary? The comment letter requests flexibility to use the attained age as of either the previous or subsequent policy anniversary, or any age between those two ages. The final regulations address this issue by clarifying that the attained age of the insured under a contract, once determined, changes annually. This rule is set forth in § 1.7702-2(b)(2). C. Use of Derived Ages for Multiple Life Contracts Under the proposed regulations, the attained age of the insured under a contract insuring multiple lives is either the attained age of the youngest insured (in the case of a last-to-die contract) or the attained age of the oldest insured (in the case of a first-to-die contract). Some issuers, however, determine mortality charges under such contracts using a single, derived age that does not correspond to the attained age of any single insured under the contract. In addition, in some cases issuers currently account for substandard risks by determining mortality charges based on an age that is older than the actual attained age of the insured under the contract. The comment letter requested a rule that would permit the use of the same derived age as the *attained age* of the insured in these circumstances, to avoid whatever administrative complexities could result from the use of different ages for different purposes in the course of testing compliance of the contracts with sections 7702 and 7702A. The final regulations do not make this change. The manner in which age is used to determine *reasonable mortality charges* under section 7702(c)(3)(B)(i) is independent of the age that is treated as the *attained age* of the insured for purposes of determining the guideline level premium under section 7702(c)(4), or applying the cash value corridor of section 7702(d) or the computational rules of section 7702(e). The final regulations do not, nor are they intended to, endorse or prohibit any methodology for determining reasonable mortality charges under section 7702(c). Reasonable mortality charges were the subject of regulations proposed July 5, 1991, (FI-069-89) (1991-2 C.B. 963) in the **Federal Register** (56 FR 30718), and also were addressed in Notice 88-128, 1988-2 C.B. 540, and Notice 2004-61, 2004-2 C.B. 596. *See* § 601.601(d)(2)(ii). This prior guidance is not modified, clarified, or in any other way affected by these final regulations. D. Contract Anniversary The comment letter requested that the regulations include a definition of *contract anniversary* other than the issue date of the contract and subsequent anniversaries of that date. The final regulations do not include such a definition because the terms *issue date* and *contract year* have broad application, and it would be inappropriate to address the matter for the first time in these final regulations. E. Effective Date The proposed regulations were proposed to apply to contracts issued on or after the date that is one year after the regulations are published as final regulations in the **Federal Register** . A taxpayer would be permitted, however, to apply these final regulations retroactively for contracts issued before that date provided the taxpayer does not later determine qualification of those contracts in a manner that is inconsistent with these regulations. The comment letter requested that the final regulations conform more closely to the adoption dates for the 2001 Commissioners' Standard Ordinary mortality and morbidity tables (2001 CSO tables). These tables are now prevailing within the meaning of section 807(d)(5) and have a mandatory effective date of January 1, 2009. In some States, insurers have the option to use either the 1980 CSO tables or the 2001 CSO tables for contracts issued before January 1, 2009. Either changing from the 1980 CSO mortality tables to the 2001 CSO tables or adopting changes to the determination of the insured's attained age under this regulation (or both) may require filing new contract forms with the relevant state insurance commissioners and may require changes to existing compliance systems. Accordingly, the effective date of this final regulation has been adjusted to take into account the transition period for adoption of the new mortality tables. Specifically, the final regulations apply to life insurance contracts that are either

(1)Issued after December 31, 2008, or

(2)issued on or October 1, 2007 and based upon the 2001 CSO tables. This modification will enable issuers to make any changes required by this final regulation concurrently with the changes required by the adoption of the 2001 CSO mortality tables. In addition, taxpayers may apply the regulations for contracts issued before October 1, 2007, provided they do not later determine qualification of those contracts under section 7702 in a manner inconsistent with the regulations. Special Analyses It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) and

(d)of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding this Treasury decision was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. Drafting Information The principal author of these final regulations is Ann H. Logan, Office of the Associate Chief Counsel (Financial Institutions and Products), Office of Chief Counsel, Internal Revenue Service. However, personnel from other offices of the IRS and the Treasury Department participated in their development. List of Subjects in 26 CFR Part 1 Income taxes. Adoption of Amendments to the Regulations Accordingly, 26 CFR part 1 is amended as follows: PART 1—INCOME TAXES **Paragraph 1.** The authority citation for part 1 is amended by adding entries in numerical order to read as follows: Authority: 26 U.S.C. 7805 * * *. Section 1.7702-2 also issued under 26 U.S.C. 7702(k). * * * **Par. 2.** Section 1.7702-0 is added to read as follows: § 1.7702-0 Table of contents. This section lists the captions that appear in §§ 1.7702-1, 1.7702-2, and 1.7702-3. § 1.7702-1 Mortality charges.

(a)General rule.

(b)Reasonable mortality charges.

(1)Actually expected to be imposed.

(2)Limit on charges.

(c)Safe harbors.

(1)1980 C.S.O. Basic Mortality Tables.

(2)Unisex tables and smoker/nonsmoker tables.

(3)Certain contracts based on 1958 C.S.O. table.

(d)Definitions.

(1)Prevailing commissioners' standard tables.

(2)Substandard risk.

(3)Nonparticipating contract.

(4)Charge reduction mechanism.

(5)Plan of insurance.

(e)Effective date. § 1.7702-2 Attained age of the insured under a life insurance contract.

(a)In general.

(b)Contract insuring a single life.

(c)Contract insuring multiple lives on a last-to-die basis.

(1)In general.

(2)Modifications to cash value and future mortality charges upon the death of insured.

(d)Contract insuring multiple lives on a first-to-die basis.

(e)Examples.

(f)Effective dates.

(1)In general.

(2)Contracts issued before the general effective date. § 1.7702-3 Definitions.

(a)In general.

(b)Cash value.

(1)In general.

(2)Amounts excluded from cash value.

(c)Death benefit.

(1)In general.

(2)Qualified accelerated death benefit treated as death benefit.

(d)Qualified accelerated death benefit.

(1)In general.

(2)Determination of present value of the reduction in death benefit.

(3)Examples.

(e)Terminally ill defined.

(f)Certain other additional benefits.

(1)In general.

(2)Examples.

(g)Adjustments under section 7702(f)(7).

(h)Cash surrender value.

(1)In general.

(2)For purposes of section 7702(f)(7).

(i)Net surrender value.

(j)Effective date and special rules.

(1)In general.

(2)Provision of certain benefits before July 1, 1993.

(i)Not treated as cash value.

(ii)No effect on date of issuance.

(iii)Special rule for addition of benefit or loan provision after December 15, 1992.

(3)Addition of qualified accelerated death benefit.

(4)Addition of other additional benefits. **Par. 3.** Section 1.7702-2 is added to read as follows: § 1.7702-2 Attained age of the insured under a life insurance contract.

(a)*In general* . This section provides guidance on determining the attained age of an insured under a contract that is a life insurance contract under the applicable law, for purposes of determining the guideline level premium of the contract under section 7702(c)(4), applying the cash value corridor of section 7702(d) or applying the computational rules of section 7702(e), as applicable.

(b)*Contract insuring a single life* .

(1)If a contract insures the life of a single individual, either of the following two ages may be treated as the attained age of the insured with respect to that contract—

(i)The insured's age determined by reference to the individual's actual birthday as of the date of determination (actual age); or

(ii)The insured's age determined by reference to contract anniversary (rather than the individual's actual birthday), so long as the age assumed under the contract (contract age) is within 12 months of the actual age as of that date.

(2)Once determined under paragraph (b)(1) of this section, the attained age with respect to an individual insured under a contract changes annually. Moreover, the same attained age must be used for purposes of applying sections 7702(c)(4), 7702(d), and 7702(e), as applicable.

(c)*Contract insuring multiple lives on a last-to-die basis* —(1) *In general* . Except as provided in paragraph (c)(2) of this section, if a contract insures the lives of more than one individual on a last-to-die basis, the attained age of the insured is determined by applying paragraph

(b)of this section as if the youngest individual were the only insured under the contract for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable.

(2)*Modifications to cash value and future mortality charges upon the death of insured* . If both the cash value and future mortality charges under a contract change by reason of the death of one or more insureds to no longer take into account the attained age of the deceased insured or insureds, the youngest surviving insured shall thereafter be treated as the only insured under the contract.

(d)*Contract insuring multiple lives on a first-to-die basis* . If a contract insures the lives of more than one individual on a first-to-die basis, the attained age of the insured is determined by applying paragraph

(b)of this section as if the oldest individual were the only insured under the contract for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable.

(e)*Examples* . The following examples illustrate the determination of the attained age of the insured for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable. The examples are as follows: Example 1.

(i)X was born on May 1, 1947. X became 60 years old on May 1, 2007. On January 1, 2008, X purchases from IC a contract insuring X's life. January 1 is the contract anniversary date for all future years. IC determines X's annual premiums on an age-last-birthday basis. Based on the method used by IC to determine age, X has an attained age of 60 for the first contract year, 61 for the second contract year, and so on.

(ii)Section 1.7702-2(b)(1) permits the determination of attained age under either of two alternative approaches. Section 1.7702-2(b)(1)(i) provides that, if a contract insures the life of a single insured individual, the attained age may be determined by reference to the individual's actual birthday as of the date of determination. Under this provision, X has an attained age of 60 for the first contract year, 61 for the second contract year, and so on. Alternatively, § 1.7702-2(b)(1)(ii) provides that the insured's age may be determined by reference to contract anniversary (rather than the individual's actual birthday), so long as the age assumed under the contract is within 12 months of the actual age as of that date. If IC determines X's attained age under § 1.7702-2(b)(1)(ii), X likewise has an attained age of 60 for the first contract year, 61 for the second contract year, and so on. Whichever provision IC uses to determine X's attained age must be used consistently from year to year for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable. Example 2.

(i)The facts are the same as in *Example 1* except that, under the contract, X's annual premiums are determined on an age-nearest-birthday basis. X's nearest birthday to January 1, 2008, is May 1, 2008, when X will become 61 years old. Based on the method used by IC to determine age, X has an attained age of 61 for the first contract year, 62 for the second contract year, and so on.

(ii)Section 1.7702-2(b)(1) permits the determination of attained age under either of two alternative approaches. Section 1.7702-2(b)(1)(i) provides that, if a contract insures the life of a single insured individual, the attained age may be determined by reference to the individual's actual birthday as of the date of determination. Under this provision, X has an attained age of 60 for the first contract year, 61 for the second contract year, and so on. Alternatively, § 1.7702-2(b)(1)(ii) provides that the insured's age may be determined by reference to contract anniversary (rather than the individual's actual birthday), so long as the age assumed under the contract is within 12 months of the actual age as of that date. If IC determines X's attained age under § 1.7702-2(b)(1)(ii), X has an attained age of 61 for the first contract year, 62 for the second contract year, and so on. Whichever provision IC uses to determine X's attained age must be used consistently from year to year for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable. Example 3.

(i)The facts are the same as in *Example 1* except that the face amount of the contract is increased on May 15, 2011. During the contract year beginning January 1, 2011, the age assumed under the contract on an age-last-birthday basis is 63 years. However, X has an actual age of 64 as of the date the face amount of the contract is increased.

(ii)Section 1.7702-2(b)(1)(ii) provides that the insured's age may be determined by reference to contract anniversary (rather than the individual's actual birthday), so long as the age assumed under the contract is within 12 months of the actual age. Section 1.7702-2(b)(2) provides that, once determined under paragraph (b)(1) of this section, the attained age with respect to an individual insured under a contract changes annually. Accordingly, X continues to be 63 years old throughout the contract year beginning January 1, 2011, for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable. Example 4.

(i)The facts are the same as in *Example 1* except that in addition to X (born in 1947), the insurance contract also insures the life of Y, born on September 1, 1942. The death benefit will be paid when the second of the two insureds dies.

(i)The facts are the same as *Example 4* except that X (the younger of the two insureds) dies in 2012. After X's death, both the cash value and mortality charges of the life insurance contract are adjusted to take into account only the life of Y.

(ii)Section 1.7702-2(c)(1) provides that if a life insurance contract insures the lives of more than one individual on a last-to-die basis, the attained age of the insured is determined by applying § 1.7702-2(b) as if the youngest individual were the only insured under the contract. Paragraph (c)(2) of this section provides that if both the cash value and future mortality charges under a contract change by reason of the death of an insured to no longer take into account the attained age of the deceased insured, the youngest surviving insured is thereafter treated as the only insured under the contract. Because both the cash value and mortality charges are adjusted after X's death to take into account only the life of Y, only the attained age of Y is taken into account after X's death for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable. Example 6.

(i)The facts are the same as *Example 1* except that in addition to X (born in 1947), the insurance contract also insures the life of Z, born on September 1, 1952. The death benefit will be paid when the first of the two insureds dies.

(ii)Section 1.7702-2(d) provides that if a life insurance contract insures the lives of more than one individual on a first-to-die basis, the attained age of the insured is determined by applying § 1.7702-2(b) as if the oldest individual were the only insured under the contract. Because X is older than Z, the attained age of X must be used for purposes of sections 7702(c)(4), 7702(d), and 7702(e), as applicable.

(f)*Effective dates* —(1) *In general* . Except as provided in paragraph (f)(2) of this section, these regulations apply to all life insurance contracts that are either—

(i)Issued after December 31, 2008; or

(ii)Issued on or after October 1, 2007 and based upon the 2001 CSO tables.

(2)*Contracts issued before the general effective date* . Pursuant to section 7805(b)(7), a taxpayer may apply these regulations retroactively for contracts issued before October 1, 2007, provided that the taxpayer does not later determine qualification of those contracts in a manner that is inconsistent with these regulations. Deborah M. Nolan, Acting Deputy Commissioner for Services and Enforcement. Approved: September 6, 2006. Eric Solomon, Acting Deputy Assistant Secretary of the Treasury (Tax Policy). [FR Doc. E6-15117 Filed 9-12-06; 8:45 am] BILLING CODE 4830-01-P POSTAL SERVICE 39 CFR Parts 952, 953, and 964 Rules of Practice in Proceedings Relative to False Representation and Lottery Cases, Determinations of Nonmailability and Disposition of Mail Withheld From Delivery: Changes in Responsibility for Litigation AGENCY: Postal Service. ACTION: Final rule. SUMMARY: The Postal Service TM is transferring responsibility for representation of the Postal Service in certain consumer protection administrative actions before the Judicial Officer Department from the Office of the General Counsel to the Inspection Service Office of Counsel. DATES: Effective Date: September 13, 2006. FOR FURTHER INFORMATION CONTACT: Diane Mego, Staff Counsel, Judicial Office, 703-812-1905. SUPPLEMENTARY INFORMATION: Administrative adjudications involving false representation, illegal lotteries, and false and fictitious names or addresses have been brought before the Postal Service Judicial Office Department by attorneys assigned to the Office of General Counsel, with the inspector-attorneys serving as co-counsel. These matters will now be brought before the judicial officer by representatives assigned to the Inspection Service Office of Counsel. In addition, the Inspection Service Office of Counsel will also assume responsibility for representation of the Postal Service in appeals of determinations of nonmailability arising in connection with illegal lottery materials and fraudulent payment instruments identified at ports of entry into the United States by Customs and Border Protection agents. The Office of General Counsel will, however, continue to represent the Postal Service in mailability proceedings arising from appeals of decisions of the Pricing and Classification Service Center. List of Subjects in 39 CFR Parts 952, 953 and 964 Administrative practice and procedure, Fraud, Lotteries, Postal Service. For the reasons set out in this document, the Postal Service amends 39 CFR parts 952, 953 and 964 as set forth below. PART 952—[AMENDED] 1. The authority citation for part 952 continues to read as follows: Authority: 39 U.S.C. 204, 401, 3005, 3012, 3016. § 952.5 [Amended] 2. In § 952.5, in the first sentence remove the words “General Counsel of the Postal Service or his designated representative” and add in their place the words “the Chief Postal Inspector or his or her designated representative.” In the last sentence of the first paragraph remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or designee.” § 952.29 [Amended] 3. In § 952.29, in the second sentence remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” § 952.30 [Amended] 4. In § 952.30, in the first sentence remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” PART 953—[AMENDED] 5. The authority citation for 39 CFR part 953 continues to read as follows: Authority: 39 U.S.C. 204, 401. § 953.3 [Amended] 6. In § 953.3, in § 953.3(e) add the words “or Chief Postal Inspector's or his or her designee's reply” after the words “General Counsel's.” § 953.4 [Amended] 7. Amend § 953.4 as follows: A. In paragraph

(a)introductory text, add the words “or Chief Postal Inspector's or his or her designee's” after the words “General Counsel's.” B. In paragraph (a)(2)(i) add the words “or the Chief Postal Inspector or his or her designee” after the words “General Counsel.” C. In paragraph (b), in the first sentence add the words “or the Chief Postal Inspector or his or her designee” after the words “General Counsel” and in the second sentence add the words “or the Chief Postal Inspector's or his or her designee's” after the words “General Counsel's.” D. In paragraph (c), add the words “, the Chief Postal Inspector, or his or her designee,” after the words “General Counsel.” § 953.7 [Amended] 8. In § 953.7 [Amended], in the first sentence add the words “or the Chief Postal Inspector or his or her designee” after the words “General Counsel.” In the second sentence add the words “or the Chief Postal Inspector or his or her designee” after the words “General Counsel.” § 953.16 [Amended] 9. In § 953.16 in the third sentence add the words “or Chief Postal Inspector or his or her designee” after the words “General Counsel.” In the fifth sentence, add the words “or Chief Postal Inspector or his or her designee” after the words “General Counsel.” PART 964—[AMENDED] 10. The authority citation for 39 CFR part 964 continues to read as follows: Authority: 39 U.S.C. 204, 401, 3003, 3004. 11. Amend § 964.3 as follows: § 964.3 [Amended] A. In paragraph (a), in the fifth sentence remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” In the last sentence, remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” B. In paragraph (b), the last sentence, remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” C. In paragraph (c), remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” D. In paragraph (d), remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” § 964.20 [Amended] 12. In § 964.20, remove the words “General Counsel” and add in their place the words “Chief Postal Inspector or his or her designee.” Stanley F. Mires Chief Counsel, Legislative and Policy. [FR Doc. E6-15113 Filed 9-12-06; 8:45 am] BILLING CODE 7710-12-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 62 [R01-OAR-2006-0668; FRL-8219-2] Approval and Promulgation of State Plans for Designated Facilities and Pollutants: Vermont; Negative Declaration AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving the Sections 111(d) and 129 negative declaration submitted by the Vermont Department of Environmental Conservation (VT DEC) on June 30, 2006. This negative declaration adequately certifies that there are no existing “other solid waste incineration units” (OSWIs) located within the boundaries of the State of Vermont. EPA publishes regulations under Sections 111(d) and 129 of the Clean Air Act requiring states to submit control plans to EPA. These state control plans show how states intend to control the emissions of designated pollutants from designated facilities ( *e.g.* , OSWIs). The State of Vermont submitted this negative declaration in lieu of a state control plan. DATES: This direct final rule is effective on November 13, 2006 without further notice unless EPA receives significant adverse comment by October 13, 2006. If EPA receives adverse comment, we 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 Number EPA- R01-OAR-2006-0668 by one of the following methods: A. *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. B. *E-mail:* *brown.dan@epa.gov.* C. *Fax:*

(617)918-0048. D. *Mail:* “EPA-R01-OAR-2006-0668”, Daniel Brown, Chief, Air Permits, Toxics & Indoor Programs Unit, Office of Ecosystem Protection, U.S. EPA, One Congress Street, Suite 1100 (CAP), Boston, Massachusetts 02114-2023. E. *Hand Delivery or Courier.* Deliver your comments to: Daniel Brown, Chief, Air Permits, Toxics & Indoor Programs Unit, Office of Ecosystem Protection, U.S. EPA, One Congress Street, Suite 1100 (CAP), Boston, Massachusetts 02114-2023. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30 excluding Federal holidays. *Instructions:* Direct your comments to Docket ID Number EPA-R01-OAR-2006-0668. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* , or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *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. *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 Office of Ecosystem Protection, U.S. Environmental Conservation Agency, EPA New England Regional Office, One Congress Street, Suite 1100, Boston, MA. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section below to schedule your review. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30 excluding Federal holidays. FOR FURTHER INFORMATION CONTACT: Daniel Brown, Chief, Air Permits, Toxic & Indoor Air Programs Unit, Office of Ecosystem Protection (CAP), EPA—New England, Region 1, Boston, Massachusetts 02203, telephone number

(617)918-1048, fax number

(617)918-0048, e-mail *brown.dan@epa.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. What action is EPA taking today? II. What is the origin of the requirements? III. When did the requirements first become known? IV. When did Vermont submit its negative declaration? V. Statutory and Executive Order Reviews I. What action is EPA taking today? EPA is approving the negative declaration of air emissions from OSWI units submitted by the State of Vermont. EPA is publishing this negative declaration without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this **Federal Register** , EPA is publishing a separate document that will serve as the proposal to approve this negative declaration should relevant adverse comments be filed. If EPA receives no significant adverse comment by October 13, 2006, this action will be effective November 13, 2006. If EPA receives significant adverse comments by the above date, we will withdraw this action before the effective date by publishing a subsequent document in the **Federal Register** that will withdraw this final action. EPA will address all public comments received in a subsequent final rule based on the parallel proposed rule published in today's **Federal Register** . EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. II. What is the origin of the requirements? Under Section 111(d) of the Clean Air Act, EPA published regulations at 40 CFR Part 60, Subpart B which require states to submit plans to control emissions of designated pollutants from designated facilities. In the event that a state does not have a particular designated facility located within its boundaries, EPA requires that a negative declaration be submitted in lieu of a control plan. III. When did the requirements first become known? On December 9, 2004, EPA proposed emission guidelines for OSWI units. This action enabled EPA to list OSWI units as designated facilities. By proposing these guidelines, EPA specified particulate matter, opacity, sulfur dioxide, hydrogen chloride, oxides of nitrogen, carbon monoxide, lead, cadmium, mercury, and dioxins/furans as designated pollutants. These guidelines were published in final form on December 16, 2005 (70 FR 74870) and codified at 40 CFR part 60, subpart EEEE. IV. When did Vermont submit its negative declaration? On June 30, 2006, the Vermont Department of Environmental Conservation (VT DEC) submitted a letter certifying that there are no existing OSWI units subject to 40 CFR Part 60, Subpart B. Section 111(d) and 40 CFR 62.06 provide that when no such designated facilities exist within a state's boundaries, the affected state may submit a letter of “negative declaration” instead of a control plan. EPA is publishing this negative declaration at 40 CFR 62.11490. V. 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), because it 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 section 111(d) submissions, EPA's role is to approve state plans, 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 state plan submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a state plan submission, to use VCS in place of a state plan 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. 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. 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 November 13, 2006. Interested parties should comment in response to the proposed rule rather than petition for judicial review, unless the objection arises after the comment period allowed for in the proposal. 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 62 Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides, Waste treatment and disposal. Dated: September 2, 2006. Robert W. Varney, Regional Administrator, EPA New England. 40 CFR Part 62 is amended as follows: PART 62—[AMENDED] 1. The authority citation for Part 62 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart UU—Vermont 2. Subpart UU is amended by adding a new § 62.11490 and a new undesignated center heading to read as follows: Air Emissions From Existing Other Solid Waste Incineration Units § 62.11490 Identification of Plan-negative declaration. On June 30, 2006, the Vermont Department of Environmental Conservation submitted a letter certifying that there are no existing other solid waste incineration units in the state subject to the emission guidelines under part 60, subpart EEEE of this chapter. [FR Doc. E6-15198 Filed 9-12-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0695; FRL-8089-7] Eucalyptus Oil; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of eucalyptus oil on honey and honeycomb when applied at 2 g or less eucalyptus oil per hive to suppress varroa mites. Brushy Mountain Bee farm, c/o IR-4 Project submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of eucalyptus oil in honey and honeycomb. DATES: This regulation is effective September 13, 2006. Objections and requests for hearings must be received on or before November 13, 2006, 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-2006-0695. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* ,or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and Pollution Prevention Division (7511P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-9525; e-mail address: *benmhend.driss@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0695 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 13, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0695, by one of the following methods. • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of July 19, 2006 (71 FR 41018) (FRL-8077-8), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition PP 6E7082 by Brushy Mountain Bee farm, c/o IR-4 Project Rutgers University, 681 U.S. Highway 1 South, North Brunswick, New Jersey 08902. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of eucalyptus oil. This notice included a summary of the petition prepared by the petitioner Brushy Mountain Bee farm, c/o IR-4 Project Rutgers. There were no comments received in response to the notice of filing. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption 6efrom the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.... ” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues ” and “other substances that have a common mechanism of toxicity.” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. III. Toxicological Profile Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Eucalyptus oil

(EO)is an essential oil that is obtained from steam distillation of the leaves of *Eucalyptus globulus* . Eucalyptus oil has a long history of safe medicinal uses and has been classified by FDA as a GRAS substance and permitted as a direct additive to foods for human consumption (21 CFR 172.510). It is used as a component of decongestant products, as an expectorant component of cough and cold products, in various oral dosages from (e.g., lozenges and syrups), and as an inhalant in vapor baths, etc. In 2002, 100,000 tons of Halls cough drops were consumed. There are no incident reports of adverse effects associated with exposures to EO. There is limited information in the public literature and information reported by the FDA that provides a limit to the levels of EO that can be present in foods and or medicines. One exception however, is that EO is currently allowed at 1.2 to 1.3% (12,000 to 13,000 mg/kg) as a topical antitussive drug in mixtures with camphor and menthol (21 CFR 341.14(b); 341.40(u); 341.74(b),(c),(d)). A topical antitussive is defined as a drug that relieves cough when inhaled after being applied topically to the throat or chest in the form of an ointment or from a steam vaporizer or when dissolved in the mouth in the form of a lozenge for a local effect (21 CFR 341.3(c). Eucalyptus oil can be used orally in cough drops at 162 to 2,000 mg/kg (Ref. 1). There is information in the public literature that EO is known to be toxic at high levels. However, based on the most likely use pattern for EO as a pesticide, the Agency has determined that EO, when used as a pesticide, will be safe because it is likely to be used at very low levels. The lack of information in the public literature on the levels of EO that is present in certain foods and medicines is due to a lack of an available method to detect residues of eucalyptus oil in foods and medicines. This is primarily due to the fact that most essential oils from plants such a *Eucalyptus* spp. contain many components and therefore, may be difficult to characterize the actual oil component. Eucalyptus oil from *Eucalyptus globulus* is composed eucalyptol, triterpenes, monoterpenes, sesquiterpenes, aldehydes and ketones of which eucalyptol (1,8-cineole) makes up to 80% or more of EO. Since there is no method of detection for EO in foods, the Agency has conducted a dietary risk assessment in order to estimate the exposure to eucalyptus oil when used as a pesticide in or on honey and honey comb. Toxicity data requirements were satisfied by the registrant with data and/or information from the public literature and requests to waive toxicity testing for the studies below. Data waiver rationales were provided and were acceptable and therefore data waivers were granted by the Agency. A. Acute and Short-term Toxicity Information submitted by the applicant demonstrated that acute oral LD 50 values for EO is 4,400 mg/kg body weight in rats, 3,320 mg/kg body weight in mice, and a dermal LD 50 of > 5,000 mg/kg body weight in rabbits. These classify EO as Toxicity Category IV for acutely toxic oral and dermal effects. EO is also a mild dermal irritant (Ref. 2). Embryotoxicity and fetotoxicity were not observed in a teratogenicity study in which mice were dosed with EO (from *Eucalyptus globulus* ) subcutaneously during days 6-15 of gestation (Ref. 1). Acute inhalation toxicity and primary eye irritation studies on EO were waived because the product requires personal protective equipment equivalent to Toxicity Category I. Inhalation and eye irritation only apply to workers using the product and not to people consuming the honey because the EO residue levels in honey are so low (0.125 ppm) when applied at 2g or less EO per hive. In addition, EO has a long history of safe use as a common ingredient in ointments applied to the skin and steam vaporizer solution for the relief of cold and flu symptoms. Hypersensitivity incidents must be reported to the Agency. No incidents have been reported during the last few years when EO in combination with other compounds has been used under the FIFRA section 18 program to control Varroa mites in bees. B. Genotoxicity / Mutagenicity Data submitted supported the waiver request for genotoxicity. No genotoxicity was observed following exposure of eucalyptus oil to *Salmonella* strains TA100, TA1535, TA1537, TA98 in tests with or without activation by rat and hamster liver S9 fractions (Ref. 3). An additional study (Ref. 4) also reported that eucalyptol, the main component of eucalyptus oil, was negative for mutation in *S. typhimurium* strains TA100, TA97A, TA98, TA102 both with and without metabolic activation (via rat liver S-9). Other *in vitro* studies show a weak positive to positive increases in sister chromatid exchanges were reported in Chinese hamster ovary

(CHO)cells without metabolic activation (Ref. 5). Equivocal or weakly positive increases in chromosome aberrations were observed in CHO cells with S9 metabolic activation (Ref. 5). Overall, the weight of evidence suggests that EO is not genotoxic or mutagenic. C. Subchronic Toxicity Oral subchronic studies are typically required when the pesticidal use requires a tolerance or an exemption from the requirement of a tolerance, a food additive regulation, or its use results in repeated human oral exposure. Dietary subchronic exposure to EO in honey is probable. EO residues are found in other food items at significantly higher concentrations than those resulting from pesticidal treatments. Because the dietary contribution of EO from honey is expected to be negligible compared to that already in the diet, subchronic studies are not required. IV. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The Agency believes that establishing a tolerance exemption for residues of eucalyptus oil in or on honey or honey comb will not cause any new exposure that would not be safe. As mentioned in Unit III., the U.S. population in general is already exposed to EO from the consumption of cough lozenges and other food products at levels which are equivalent to the limit levels for this tolerance exemption without any reports of adverse effects. Further, the daily exposure to EO from honey consumption is negligible when compared to the level ingested for therapeutic use. In order to validate the determination that any new exposure from the use of eucalyptus oil is safe, the Agency conducted a dietary risk assessment using magnitude of residue data measuring eucalyptol and adjusted by 20 percent because eucalyptol is 80 percent of EO. As a result of this risk assessment, the Agency concludes that the use of EO when used as a pesticide on honey or honey comb to suppress varroa mites when applied at 2g or less EO will not add any new exposures or risks and is considered safe. A. Dietary Exposure A dietary risk was estimated by comparing theoretical exposures using the EO residues approved for use by FDA in cough drops as stated above. These theoretical exposures were compared to the current consumption of eucalyptol, the therapeutic dose of eucalyptol. Comparisons were not calculated for the infant population because honey is generally not recommended for infant consumption due to the dangers it can pose to infants. Before comparisons could be made, exposures had to be put into terms of EO, not the marker analyte eucalyptol as described above. The amount of eucalyptus oil allowed in cough drops is 2,000 ppm which is 16,000 times that found in the honey submitted residue trial (Ref. 6). Based on the dietary risk assessment conducted by the Agency, it has been determined that daily exposures to EO from honey consumption would be orders of magnitude less than the level ingested for therapeutic use. Therefore, the Agency concludes that residues of EO in honey when applied at 2g or less per hive are of no dietary concern to the U.S. population including children. 1. *Food.* Eucalyptus oil is commonly found in numerous food items such as yellow cake, vanilla ice cream, cola beverages, and caramel candy. In 2002, people consumed 100,000 tons of Halls drops ( *http://www.cadburyschweppes.com/EN /Brands/About/Confectionery/factsheet_halls.htm* ); while in the Northern Hemisphere these are sold as cough drops, other parts of the world consume them as candy. The daily exposure to EO from honey consumption when used at 2g or less is orders of magnitude less than the level ingested for therapeutic use (Ref. 1). Therefore, residues of EO in honey are not considered a dietary concern. Conservative exposure estimates and the use of lowest toxicity concentrations ensure that residues of EO present a reasonable certainty of no harm. Therefore, no adverse effects associated with exposures to EO by oral route are expected from the use of EO as a pesticide when used at 2g or less EO per hive. 2. *Drinking water exposure* . No exposure to EO residues in drinking water is expected because the use of this product is limited to application within the hive box in which the product is contained in a dispenser tray, where the product is rapidly volatilized or redistributed. 3. *Magnitude of the Residue in/on Honey and Honeycomb* . The end-use product, ApiLife VAR, has acceptable magnitude of the residue data on eucalyptol in honey and honeycomb when used as a treatment for Varroa mites in bee hives (Ref. 6; Ref. 7). Eucalyptol is the marker analyte for EO and comprises 80% (v/v) of the original mixture. Residue estimates and dietary exposures estimated with eucalyptol (0.1 mg/kg) were modified to account for the percentage of eucalyptol in EO (80%). Essentially, this meant increasing these estimates by 20% (equivalent to 0.125 mg/kg EO residues). The dietary exposure of eucalyptol in honey is below EPA's levels of concern for all population subgroups (Ref. 1). B. Other Non-Occupational Exposure The potential for non-dietary exposure to EO residues for the general population, including infants and children, is unlikely because the proposed use-site is limited to beehives. V. Cumulative Effects There is no indication that the toxic effects of EO are cumulative. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, EPA consider available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity. EPA does not have, at this time, available data to determine whether EO has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to EO and any other substances and EO 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 EO has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . VI. Determination of Safety for U.S. Population, Infants and Children There is a reasonable certainty that no harm will result to the U.S. population including children from aggregate exposure to residues of EO as a result of its use as a pesticide in or on honey and honey comb when used at 2g or less EO per hive since no toxicity is expected and the U.S. population in general is already exposed to EO from the consumption of cough lozenges at much higher levels without any reports of adverse effects. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The anticipated residues in honey are at 0.125 ppm, which is more than 16,000 times lower than the established acceptable level in cough lozenges. Moreover, at high levels, EO gives off an undesirable or ill taste to the palate when consumed at levels which far exceed those levels reported for medicinal uses such as teas. For these reasons, it is unlikely that EO will be consumed at levels exceeding those reported here based on the undesirable taste alone. In addition, there is very little potential for exposure to EO from drinking water since the product will volatize or exposure and is limited to beehives or from non dietary, non occupational exposure since its use is limited to beehives. Therefore, based on its long history of safe use therapeutic and medicinal agents without any reports of any toxic or adverse effects and the fact that EO is classified by FDA as a substance that is generally recognized as safe

(GRAS)when used as a direct additive to foods for human consumption, the Agency believes that the health risk to humans is negligible and concludes that there is a reasonable certainty that no harm will result from aggregate exposures to EO. VII. Other Considerations A. Endocrine Disruptors EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen- and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). At this time, the Agency is not requiring information on the endocrine effects of this active ingredient, EO. Based on the weight of the evidence of available data and the absence of any reports to the Agency of sensitivity or other adverse effects, no endocrine system related effects are identified for EO and none is expected because of its use. To date there is no evidence that EO affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor. Thus, there is no impact via endocrine-related effects on the Agency's safety finding set forth in this proposed rule to establish an exemption from the requirement of a tolerance for residues of EO used at 2g or less EO per hive. B. Analytical Method Through this action the Agency proposes to establish an exemption from the requirement of a tolerance for EO on honey and honeycomb when used at 2g or less EO per hive to suppress varroa mites. This decision was reached based on the reasons stated above which include low toxicity to mammals and negligible exposure from the pesticidal use of products containing EO. For the same reasons, the Agency concludes that an analytical method is not required for enforcement purposes for EO. C. Codex Maximum Residue Level There are no CODEX maximum residues levels for EO. VIII. Conclusions Based on the data submitted and other information available to the Agency, there is a reasonable certainty that no harm will result from the aggregate exposure to residues of EO to the U.S. population, including infants and children, under reasonable foreseeable circumstances, when the biochemical pesticide EO is used in accordance with the product label directions and at 2 g or less eucalyptus oil per hive. This includes all anticipated dietary exposures and all other non-occupational exposures for which there is reliable information. The Agency has arrived at this conclusion based on the information/data submitted (and publicly available) demonstrating relatively low toxicity of EO. As a result, EPA is establishing an exemption from the tolerance requirements pursuant to FFDCA 408(c) and

(d)for residues of EO in or on honey, honeycomb and honeycomb with honey when used at 2g or less EO per hive. IX. References 1. August 8, 2006. EPA Memo: Api Life VAR: Toxicology Review and a Dietary Exposure Assessment for Eucalyptus Oil (CAS No. 6000-48-4) in Support of an Exemption for the Requirement of a Tolerance. Kent Carlson to Driss Benmhend. 2. Inchem. 2004. Aliphatic and Aromatic Ethers. Chapter 2.2.2 Toxicological Studies. JEFCA. 52 3. National Toxicology Program. 1982. *Salmonella* assay for genetic toxicity from exposure to 1,8 cineole. Study 246429. 4. Gomes-Carneiro. R. 1998. Mutagenicity testing ()-camphor, 1,8 cineole, citral, citronellol, (-)-menthol, and terpineol with the Salmonella microsome assay. Mutation Research. 416(1-2). 129-136. 5. National Toxicology Program. 1982. CHO cell cytogenetics; chromosome aberrations and sister chromatid exchanges from exposure to 1,8 cineole. Study 590755. 6. July 25, 2005. MRID 466828-01. Thymol, Eucalyptol, Campho: Magnitude of the Residue on honey and beeswax. IR-$ PR No. 08661. 251pp. 7. June 29, 2006. EPA Memo: Apilife VAR: Dietary Exposure Assessment Involving Review of Toxicology and Exposure Data to Address Application to Bee Hives. Kent Carlson to Driss Benmhend. X. Statutory and Executive Order Reviews This final rule establishes an exemption from the requirement of a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption from the requirement of a tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq* .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule XI. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 31, 2006. James Jones, Director, Office of Pesticides 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 180.1271 is added to subpart D to read as follows: § 180.1271 Eucalyptus oil; exemption from the requirement of a tolerance. An exemption from the requirement of tolerance is established for residues of eucalyptus oil in or on honey, honeycomb, and honeycomb with honey when used at 2g or less eucalyptus oil per hive, where the eucalyptus oil contains 80% or more eucalyptol. [FR Doc. E6-14995 Filed 9-12-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0024; FRL- 8085-1] Difenoconazole; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole), when used as a seed treatment in or on barley, hay; barley, straw; corn, sweet, forage; corn, sweet, kernel plus cob with husks removed; corn, sweet, stover; cotton, gin byproducts; cotton, undelinted seed; and as a foliar treatment on fruit, pome, group 11 (import); and on grape (import). Syngenta Crop Protection, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). This rule also revises the chemical name of the active ingredient, difenoconazole, from [(2S,4R)/(2R/4S)]/[(2R/4R)]/(2S,4S) 1-(2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-methyl)-1H-1,2,4-triazole, to the following, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole). EPA is also deleting certain difenoconazole tolerances that are no longer needed as result of this action. DATES: This regulation is effective September 13, 2006. Objections and requests for hearings must be received on or before November 13, 2006, 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-2006-0024. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-9443; e-mail address: *kish.tony@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this “ **Federal Register** ” document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0024 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 13, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0024, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 12, 2006 (71 FR 18748) (FRL-7765-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0F6155, 6F4748, 8F4953, and 9E5076) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.475 be amended by establishing tolerances for residues of the fungicide difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole), when used as a seed treatment, in or on barley, hay at 0.05 parts per million

(ppm)(PP 6F4748); barley, straw at 0.05 ppm (PP 6F4748); corn, sweet, forage at 0.01 ppm (PP 0F6155); corn, sweet, kernel plus cob with husks removed at 0.01 ppm (PP 0F6155); corn, sweet, stover at 0.01 ppm (PP 0F6155); cotton, gin byproducts at 0.05 ppm (PP 8F4953); cotton, undelinted seed at 0.05 ppm (PP 8F4953); and as a foliar treatment on fruit, pome, group 11 at 0.10 ppm (PP 9E5076); and on grape at 0.1 ppm (9E5076). That notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing. Syngenta requested a tolerance of 0.05 ppm on barley, forage. However, a tolerance is not being established for barley forage because: It is an insignificant animal feed item; it is not included in Table 1 of the Residue Chemistry Test Guidelines, OPPTS 860.1000; and it is not an accepted name in the Food and Feed Commodity Vocabulary ( *http://www.epa.gov/pesticides/foodfeed/* ); for these reasons, a tolerance is not required. EPA is also deleting several established tolerances in § 180.475(b) that are no longer needed, as a result of this action. The tolerance deletions under § 180.475(b) are time-limited tolerances established under section 18 emergency exemptions that are superceded by the establishment of permanent tolerances for difenoconazole § 180.475(a). The revisions to § 180.475 are as follows: 1. Delete the time-limited tolerance (expires 12/31/08) for corn, sweet, kernel plus cob with husks removed at 0.1 ppm under § 180.475(b), because a permanent tolerance for corn, sweet, kernel plus cob with husks removed at 0.01 ppm is being established by this action under § 180.475(a). 2. Delete the time-limited tolerance (expires 12/31/08) for corn, sweet, forage at 0.1 ppm under § 180.475(b), because a permanent tolerance for corn, sweet, forage at 0.01 ppm is being established by this action under § 180.475(a). 3. Delete the time-limited tolerance (expires 12/31/08) for corn, sweet, stover at 0.1 ppm under § 180.475(b) because a permanent tolerance for corn, sweet, stover at 0.01 ppm is being established by this action under § 180.475(a). Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for residues of difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole), when used as a seed treatment in or on barley, hay at 0.05 ppm; barley, straw at 0.05 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; cotton, gin byproducts at 0.05 ppm; cotton, undelinted seed at 0.05 ppm; and as a foliar treatment on fruit, pome, group 11 at 0.10 ppm; and on grape at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by difenoconazole 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 the following website: *http://www.epa.gov/fedrgstr/EPA-PEST/2000/September/Day-15/p23773.htm.* B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(dose)from the oral toxicity studies was identified. The Dietary Exposure Evaluation Model with Food Commodity Intake Database (DEEM-FCID TM , version 2.03) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance-level residues; 100% percent of each crop treated; and DEEM TM , version 7.76, processing factors for all proposed and registered commodities. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID TM , version 2.03, which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance-level residues for barley, rye, and all proposed commodities; anticipated residues for all previously registered commodities, except barley and rye; 100% of each crop treated; and DEEM TM , version 7.76, default processing factors for all commodities. iii. *Cancer* . The Agency determined that a reference dose

(RfD)approach is appropriate to evaluate potential cancer risk to difenoconazole because the chronic RfD is lower than the cancer RfD. No separate exposure assessment was conducted for evaluating cancer risk. iv. *Anticipated residue and percent crop treated

(PCT)information* . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such data call-ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data call-ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for difenoconazole in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of difenoconazole. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppfead1/trac/science* . Based on the First Index Reservoir Screening Tool (FIRST) and screening concentration in groundwater (SCI-GROW) models, the estimated environmental concentrations

(EECs)of difenoconazole for acute exposures are estimated to be 0.60 parts per billion

(ppb)for surface water and 0.00084 ppb for ground water. The EECs for chronic exposures are estimated to be 0.14 ppb for surface water and 0.00084 ppb for ground water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Difenoconazole is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Difenoconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between this pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). A variable pattern of toxicological responses are found for conazoles. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles have a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to the toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . The Agency's risk assessment for the common metabolites is available in the propiconazole reregistration docket at *www.regulations.gov* in docket ID number EPA-HQ-OPP-2005-0497. D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . The evidence shows that difenoconazole is neither a developmental nor a reproductive toxicant, and that there are no residual uncertainties in the toxicology database for difenoconazole. Therefore, infants and children are not expected to exhibit increased sensitivity and the Agency's LOC for prenatal and postnatal toxicity is not exceeded. 3. *Conclusion* . The Agency has concluded that the default 10x FQPA Safety Factor should be reduced to 1x in assessments of both acute and chronic dietary exposures, for the following reasons: There is a complete toxicological database for difenoconazole; there was no evidence of increased pre-natal or post-natal susceptibility to difenoconazole; difenoconazole is neither a developmental nor a reproductive toxicant; exposure data are complete, or are estimated, based on data that reasonably account for potential exposures; and there is high overall confidence in the risk assessment. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to difenoconazole will occupy < 1.0% of the acute population adjusted dose

(aPAD)for females 13-49 years old. An endpoint of concern attributable to a single exposure

(dose)was not identified from the oral toxicity studies (including the rat and rabbit developmental toxicity studies) for the general U.S. population, or for the infants and children subgroups, therefore acute risk analyses were not performed for these groups. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to difenoconazole from food and water will utilize 2.4% of the chronic population adjusted dose

(cPAD)for the U.S. population; 10% of the cPAD for all infants ( < 1 year old); and 16% of the cPAD for children 1-2 years old. There are no residential uses for difenoconazole that result in chronic residential exposure to difenoconazole. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure in addition to chronic exposure to food and water (which are considered to be the background exposure level). Difenoconazole is not registered for use on any site(s) that would result in residential exposure, so the aggregate short-term risk is solely the sum of the risk from food and water. These risks do not exceed the Agency's LOC. 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). Difenoconazole is not registered for use on any site(s) that would result in residential exposure, so the aggregate short-term risk is solely the sum of the risk from food and water. These risks do not exceed the Agency's LOC. 5. *Aggregate cancer risk for U.S. population* . The Agency determined that an RfD approach is appropriate to evaluate potential cancer risks to difenoconazole. The chronic risk assessment adequately protects against cancer risk because the chronic RfD is lower than the cancer RfD. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to difenoconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology is available for tolerance enforcement. Method AG-575B, the current enforcement method for plant commodities, quantitates levels of difenoconazole by gas chromatography

(GC)with nitrogen/phosphorous (N/P) detection. Its limit of quantitation

(LOQ)is 0.01 ppm for difenoconazole residues. Method AG-544, the current enforcement method for livestock commodities, also quantitates levels of difenoconazole by GC with N/P detection. The LOQs for difenoconazole residues using this method are 0.01 ppm in meat and eggs and 0.01 ppm in milk. Additionally a GC/mass-spectrometry detection

(MSD)method for the confirmation of difenoconazole residues in/on canola seed has recently undergone petition method validation

(PMV)at EPA's Analytical Chemistry Lab (ACL). The confirmatory method has been determined to be suitable for tolerance enforcement once the revisions recommended by ACL are incorporated into it. B. International Residue Limits There are currently no established Codex, Canadian, or Mexican maximum residue limits

(MRLs)for difenoconazole. Therefore, no conflict exists between any of the existing and proposed U.S. difenoconazole tolerances and any difenoconazole MRL. C. Response to Comments A notice of filing was published in the **Federal Register** , of April 12, 2006 (71 FR 18748, FRL-7765-7, EPA-HQ-OPP-2006-0024). No public comments were received regarding the notice. V. Conclusion Tolerances are established for residues of difenoconazole, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole), when used as a seed treatment, in or on barley, hay at 0.05 ppm; barley, straw at 0.05 ppm; corn, sweet, forage at 0.01 ppm; corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, stover at 0.01 ppm; cotton, gin byproducts at 0.05 ppm; cotton, undelinted seed at 0.05 ppm; and as a foliar treatment on fruit, pome, group 11 at 0.10 ppm; and on grape at 0.10 ppm. This rule also changes the chemical name of the active ingredient, difenoconazole, from (2S,4R)/(2R/4S)]/[(2R/4R)]/(2S,4S) 1-(2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-methyl)-1H-1,2,4-triazole, to the following, (1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole). The change in the chemical name of the active ingredient is necessary to conform to the nomenclature of the Chemical Abstracts Service, the body which the Office of Pesticide Programs regards as authoritative for issues of chemical nomenclature. This name change makes no substantive change to either the chemical identity of difenoconazole or to the effect of the tolerances. EPA is not establishing the requested tolerance of 0.05 ppm on barley, forage, because as stated previously, a tolerance is no longer required for this commodity. EPA is also deleting several established tolerances in Sec.180.475

(b)that are no longer needed, as a result of this action: 0.1 ppm on corn, sweet, kernel plus cob with husks removed with a 12/31/08 expiration date; 0.1 ppm on corn, sweet, forage with a 12/31/08 expiration data; and 0.1 ppm on corn, sweet, stover with a 12/31/08 expiration date. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 25, 2006. 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 180.475 is amended as follows: i. In paragraph

(a)by revising the chemical name of the active ingredient, difenoconazole, from “(2S,4R)/(2R/4S)]/[(2R/4R)]/(2S,4S) 1-(2-[4-(4-chlorophenoxy)-2-chlorophenyl]-4-methyl-1,3-dioxolan-2-yl-methyl)-1H-1,2,4-triazole” to “(1-[2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4-triazole)”; by alphabetically adding commodities to the table; and ii. Paragraph

(b)is removed and reserved. The amendments read as follows: § 180.475 Difenoconazole; tolerances for residues.

(a)* * * Commodity Parts per million * * * * * Barley, hay 0.05 Barley, straw 0.05 * * * * * Corn, sweet, forage 0.01 Corn, sweet, kernel plus cob with husks removed 0.01 Corn, sweet, stover 0.01 Cotton, gin byproducts 0.05 Cotton, undelinted seed 0.05 * * * * * Fruit, pome, group 11 3 0.10 * * * * * Grape 3 0.10 * * * * * 3 There are no U.S. Registrations on fruit, pome, group 11 or on grapes, as of September 13, 2006.

(b)*Section 18 emergency exemptions* . [Reserved] [FR Doc. E6-15090 Filed 9-12-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0071; FRL-8080-9] Epoxiconazole; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of epoxiconazole in or on bananas and coffee. BASF Corporation, Agricultural Products requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective September 13, 2006. Objections and requests for hearings must be received on or before November 13, 2006. ADDRESSES: EPA has established a docket for this action under docket Identification

(ID)number EPA-HQ-2005-0071. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Docket Facility is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-9354; e-mail address:waller.mary@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 affectedP entities may include, but are not limited to: • Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0071 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 13, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-0071, 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

(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of September 22, 2000, (65 FR 57338) (FRL-6737-8), and February 15, 2006, (71 FR 7952) (FRL-7759-5), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 7E4885 and 0E6128) by BASF Corporation, Agricultural Products, P.O. Box 13528; Research Triangle Park, NC 27709-3528. These petitions requested that 40 CFR 180 be amended by establishing tolerances for residues of the fungicide epoxiconazole, (2RS, 3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-2(1 *H* -1,2,4-triazol-1-yl)methyl oxirane, in or on bananas at 0.5 parts per million

(ppm)(PP 7E4885) and coffee, bean at 0.05 ppm (PP 0E6128). These notices included a summary of the petition prepared by BASF, the registrant. Comments were received on the notices of filing. EPA's response to these comments is discussed in Unit IV., C below. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for tolerances for residues of epoxiconazole in or on bananas at 0.5 parts per million

(ppm)and coffee, bean at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by epoxiconazole as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* under the docket ID number EPA-HQ-OPP-2005-0071-0005. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor

(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk and estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/oppfead1/trac/science/* , and *http://www.epa.gov/pesticides/factsheets/riskassess.htm* . Summaries of the toxicological endpoints for epoxiconazole used for the human risk assessment are shown in the following Table 1. **Table 1.—Summary of Toxicological Dose and Endpoints for Epoxiconazole for Use in Human Risk Assessment** . Exposure/Scenario Dose used in risk assessment, interspecies and intraspecies and any traditional UF Special FQPA SF and level of concern for risk assessment Study and toxicological effects Acute dietary (females 13-49 years of age) NOAEL = 5 mg/kg/day UF = 100 Acute RfD = 0.05 mg/kg/day Special FQPA SF = 1X aPAD = acute RfD/ Special FQPA SF = 0.05 mg/kg/day Developmental toxicity - rat LOAEL = 15 mg/kg/day based on increased incidence of skeletal variations Chronic dietary (all populations) NOAEL = 2 mg/kg/day UF = 100 Chronic RfD = 0.02 mg/kg/day Special FQPA SF = 1X cPAD = chronic RfD/ Special FQPA SF = 0.02 mg/kg/day 2-Year rat carcinogenicity LOAEL = 7 mg/kg/day based on increased incidences of ovarian cysts and adrenal histopathological findings in females Cancer (oral, dermal, inhalation) Classification: Likely human carcinogen with a Q 1 *(mg/kg/day)- 1 of 3.04 x 10 -2 by oral route based on the occurrence of liver tumors in male and female mice C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . This final rule establishes the first tolerances for residues of epoxiconazole in or on imported bananas and coffee. There are no registered uses in the United States, therefore the only expected exposure to epoxiconazole is from imported bananas and coffee. Risk assessments were conducted by EPA to assess dietary exposures from epoxiconazole 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 conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the United States Department of Agriculture

(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: The acute analysis was based on the highly conservative assumption of tolerance-level residues and 100% crop treated (CT). ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID TM , which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide CSFII, and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: The chronic analysis was based on the highly conservative assumption of tolerance-level residues and 100% CT. iii. *Cancer* . The Agency classified epoxiconazole as “likely to be carcinogenic to humans” by the oral route based on the occurrence of liver tumors in male and female mice. The cancer dietary exposure estimate for the general U.S. population is 3 x10 -5 mg/kg/day. The cancer dietary exposure assessment was performed for the general U.S. population using anticipated residues, and 100% CT. Anticipated residues were calculated for coffee and banana using the average field trial values from the crop field trial data. iv. *Anticipated residue and percent crop treated

(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E) of FFDCA, EPA will issue a Data Call-In for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. 2. *Dietary exposure from drinking water* . There is no expectation that epoxiconazole residues would occur in surface water or ground water sources of drinking water. Epoxiconazole is proposed for use only on imported coffee and banana commodities, the sole anticipated exposure route for the U.S. population is via dietary

(food)exposure. There are no registered uses of epoxiconazole in the United States. 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). Epoxiconazole is not registered for use on any sites that would result in residential exposure and a non-dietary risk assessment is not required. 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 mulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Epoxiconazole is a member of the triazole-containing class of pesticides. Although conazoles act similarly in plants (fungi) by inhibiting ergosterol biosynthesis, there is not necessarily a relationship between this pesticidal activity and their mechanism of toxicity in mammals. Structural similarities do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). A variable pattern of toxicological responses are found for conazoles. Some are hepatotoxic and hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some induce developmental, reproductive, and neurological effects in rodents. Furthermore, the conazoles have a diverse range of biochemical events including altered cholesterol levels, stress responses, and altered DNA methylation. It is not clearly understood whether these biochemical events are directly connected to the toxicological outcomes. Thus, there is currently no evidence to indicate that conazoles share common mechanisms of toxicity and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the conazoles. For information regarding EPA's procedures for cumulating effects from substances found to have a common mechanism of toxicity, see EPA's website at *http://www.epa.gov/pesticides/cumulative* . The Agency's risk assessment for the common metabolites is available in the prothioconazole reregistration docket at *http://www.regulations.gov* , docket ID number EPA-HQ-OPP-2005-0497. D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* .-a. There is no evidence of susceptibility following *in utero* exposure in the rabbit developmental toxicity and both *in utero* and postnatal exposure in the 2-generation rat reproduction study. b. There is low concern for the susceptibility seen in the rat developmental toxicity study because the effects observed were relatively mild for both the pregnant dams (decrease in body weight gain/food consumption) and the rat pups (increased incidence of minor skeletal variations - rudimentary cervical ribs and accessory 14 th rib). c. There does not appear to be any enhanced susceptibility in the young to endocrine effects based on the results of the two-generation study (parental male reduced adrenal weights were not observed in offspring). d. Although there is some uncertainty associated with the acute and subchronic neurotoxicity data, it is unlikely that the information requested to upgrade these studies will alter the NOAELs used for the dietary endpoints. This is because the positive findings in the acute neurotoxicity study were mild and at high doses (1,000 mg/kg in males and 2,000 mg/kg in females). Also, the piloerection observed in the females in the acute neurotoxicity study would likely have been noted or recorded during the subchronic and chronic rodent studies as part of the daily cageside observations for clinical signs. Clinical observations were made, but no signs were noted in any of the studies. This suggests that chronic exposure up to 80 mg/kg/day in rats (rat carcinogenicity study) does not lead to readily observable clinical signs such as piloerection. e. The non-cancer dietary food exposure assessment utilizes proposed tolerance level residues and 100% CT information for all commodities. By using these screening-level assessments, acute and chronic exposures/risks will not be underestimated. f. Drinking water and residential exposure are not expected. 3. *Conclusion* . There is a complete toxicity data base for epoxiconazole and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. There is no evidence of susceptibility following *in utero* and/or postnatal exposure in the rabbit developmental toxicity and in the 2-generation rat reproduction study. There is low concern for the susceptibility seen in the rat developmental toxicity study and no residual uncertainty for prenatal and/or postnatal toxicity. There is no evidence of significant neurotoxicity, as indicated by both the acute and subchronic neurotoxicity studies. Acute and chronic dietary food exposure estimates are based on conservative (Tier 1) assumptions, and will not underestimate exposure/risk. There is no potential for drinking water or residential exposure. Based on these data and conclusions, there are no FQPA UFs and the FQPA Safety Factor can be reduced to 1x. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to epoxiconazole will occupy 2% of the aPAD for females 13-49 years, the only population subgroup of concern. There are no proposed or existing residential uses for epoxiconazole. The proposed uses are limited to imported bananas and coffee. Since there are no registered uses associated with epoxiconazole in the U.S., the only route of exposure is dietary (food only). Aggregate risk is limited to dietary exposure (food only) and does not exceed the Agency's level of concern. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to epoxiconazole from food will utilize 1.0% of the cPAD for the U.S. population, 3.7% of the cPAD for all infants < 1 year, and 4.6% of the cPAD for children 1-2 years, the most highly exposed population subgroup. There are no residential uses for epoxiconazole that result in chronic residential exposure to epoxiconazole, and no exposure is expected from drinking water. Therefore, aggregate risk does not exceed the Agency's level of concern. 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). Epoxiconazole is not registered for use on any sites that would result in residential exposure and there is no expectation that epoxiconazole residues would occur via drinking water consumption. Therefore, the aggregate risk is the sum of the risk from food, which does not exceed the Agency's level of concern. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Epoxiconazole is not registered for use on any sites that would result in residential exposure and there is no expectation that epoxiconazole residues would occur via drinking water consumption. Therefore, the aggregate risk is the sum of the risk from food, which does not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . The Agency classified epoxiconazole as “likely to be carcinogenic to humans” by the oral route based on the occurrence of liver tumors in male and female mice. The estimated unit risk, Q 1 * is 3.04 x 10 -2 . The cancer dietary exposure estimate for the general U.S. population is 9.03 x 10 -7 which is below the Agency's level of concern (generally in the range of 1x 10 -6 ). 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to epoxiconazole residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (gas chromatography/electron capture detector (GC/ECD) method - BASF method 309/1) 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 0755-5350; telephone number:

(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits Codex Alimentarius and Canada have not established or proposed any MRLs for epoxiconazole. As there are no established or proposed MRLs for either banana or coffee, harmonization with international tolerances is not an issue for the current petitions. C. Response to Comments A private citizen responded to PP 0E6128. Comments were received on February 15, 2006 objecting to the use, manufacturing and sale of this product. The comments further stated that not enough tests have been completed (long term or combined tests), that there is little indication of safety and questioned the validity of animal testing. The Agency response is as follows: The Agency has a complete toxicity database on epoxiconazole, including several long-term or chronic studies. The commenter submitted no scientific information or data to support their claims. For additional in-depth response, refer to docket EPA-HQ-OPP-2004-0325, 69 FR 63083 at *http://www.regulations.gov* . V. Conclusion Therefore, tolerances are established for residues of epoxiconazole, [ *rel* -1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiranyl]methyl]-1 *H* -1,2,4-triazole], in or on bananas at 0.5 ppm and coffee at 0.05 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget

(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995

(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act

(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure“meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 28, 2006. James Jones, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.619 is added to read as follows: § 180.619 Epoxiconazole; tolerances for residues.

(a)*General* . Tolerances are established for the residues of the fungicide epoxiconazole [( *rel* -1-[[(2R,3S)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiranyl]methyl]-1 *H* -1,2,4-triazole]) in or on the following commodities: Commodity Parts per million Banana * 0.5 Coffee * 0.05 * No U.S. Registration as of August 4, 2006

(b)*Section 18 emergency exemptions* . [Reserved]

(c)*Tolerances with regional Registrations* . [Reserved]

(d)*Indirect or inadvertent residues* . [Reserved] [FR Doc. E6-14994 Filed 9-12-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [EPA-R04-RCRA-2006-0575; FRL-8219-5] Alabama: Final Authorization of State Hazardous Waste Management Program Revision AGENCY: Environmental Protection Agency (EPA). ACTION: Immediate final rule. SUMMARY: Alabama has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to Alabama. In the “Rules and Regulations” section of this **Federal Register** , EPA is authorizing the changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble of the immediate final rule. Unless we get written comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we receive comments that oppose this action, we will withdraw the immediate final rule and it will not take effect. We will respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. DATES: Final authorization will become effective on November 13, 2006 unless EPA receives adverse written comment on or before October 13, 2006. If EPA receives such comment, it will publish a timely withdrawal of this immediate final rule in the **Federal Register** and inform the public that this authorization will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-RCRA-2006-0575 by one of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: middlebrooks.gail@epa.gov.* • *Fax:*

(404)562-8439 (prior to faxing, please notify the EPA contact listed below). • *Mail* : Send written comments to Gail Middlebrooks, RCRA Services Section, RCRA Programs Branch, Waste Management Division, U.S. Environmental Protection Agency, The Sam Nunn Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. • *Hand Delivery:* Gail Middlebrooks, RCRA Services Section, RCRA Programs Branch, Waste Management Division, U.S. Environmental Protection Agency, The Sam Nunn Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R04-RCRA-2006-0575. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. 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 docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, *e.g.* , CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* , or in hard copy. You may view and copy Alabama's application at the EPA Region 4 Library, The Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The Library is open from 8 a.m. to 4:30 p.m. Monday through Friday, excluding legal holidays. The Library telephone number is

(404)562-8190. You may also view and copy Alabama's application from 8 a.m. to 4:30 p.m. at The Alabama Department of Environmental Management, 1400 Coliseum Blvd., Montgomery, Alabama 36110-2059. FOR FURTHER INFORMATION CONTACT: Gail Middlebrooks, RCRA Services Section, RCRA Programs Branch, Waste Management Division, U.S. Environmental Protection Agency, The Sam Nunn Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960;

(404)562-8494; fax number:

(404)562-8439; e-mail address: *middlebrooks.gail@epa.gov.* SUPPLEMENTARY INFORMATION: A. Why Are Revisions to State Programs Necessary? States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations

(CFR)parts 124, 260 through 266, 268, 270, 273, and 279. B. What Decisions Have We Made in This Rule? We conclude that Alabama's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we grant Alabama Final authorization to operate its hazardous waste program with the changes described in the authorization application. Alabama has responsibility for permitting Treatment, Storage, and Disposal Facilities

(TSDF)within its borders and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA take effect in authorized States before they are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in Alabama, including issuing permits, until the State is granted authorization to do so. C. What Is the Effect of This Authorization Decision? The effect of this decision is that a facility in Alabama subject to RCRA will now have to comply with the authorized State requirements instead of the equivalent Federal requirements in order to comply with RCRA. Alabama has enforcement responsibilities under its State hazardous waste program for violations of such program, but EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which include, among others, authority to: • Do inspections, and require monitoring, tests, analyses or reports. • Enforce RCRA requirements and suspend or revoke permits. • Take enforcement actions regardless of whether the State has taken its own actions. This action does not impose additional requirements on the regulated community because the regulations for which Alabama is being authorized by today's action are already effective, and are not changed by today's action. D. Why Wasn't There a Proposed Rule Before This Rule? EPA did not publish a proposal before today's rule because we view this as a routine program change and do not expect comments that oppose this approval. We are providing an opportunity for public comment now. In addition to this rule, in the proposed rules section of today's **Federal Register** we are publishing a separate document that proposes to authorize the State program changes. E. What Happens if EPA Receives Comments That Oppose This Action? If EPA receives comments that oppose this authorization, we will withdraw this rule by publishing a document in the **Federal Register** before the rule becomes effective. EPA will base any further decision on the authorization of the State program changes on the proposal mentioned in the previous paragraph. We will then address all public comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time. If we receive comments that oppose only the authorization of a particular change to the State hazardous waste program, we will withdraw that part of this rule but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The **Federal Register** withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn. F. What Has Alabama Previously Been Authorized for? Alabama initially received Final authorization on December 8, 1987, effective December 22, 1987 (52 FR 46466) to implement the RCRA hazardous waste management program. We granted authorization for changes to their program on November 29, 1991, effective January 28, 1992 (56 FR 60926), May 13, 1992, effective July 12, 1992 (57 FR 20422), October 21, 1992, effective December 21, 1992 (57 FR 47996), March 17, 1993, effective May 17, 1993 (58 FR 20422), September 24, 1993, effective November 23, 1993 (58 FR 49932), February 1, 1994, effective April 4, 1994 (59 FR 4594), November 14, 1994, effective January 13, 1995 (59 FR 56407), August 14, 1995, effective October 13, 1995 (60 FR 41818), February 14, 1996, effective April 15, 1996 (61 FR 5718), April 25, 1996, effective June 24, 1996 (61 FR 5718), November 21, 1997, effective February 10, 1998 (62 FR 62262), December 20, 2000, effective February 20, 2001 (65 FR 79769), March 15, 2005, effective May 16, 2005 (FR 70 12593), and on June 2, 2005, effective August 1, 2005 (70 FR 32247). G. What Changes Are We Authorizing With This Action? On March 6, 2006, Alabama submitted a final complete program revision application, seeking authorization of their changes in accordance with 40 CFR 271.21. Alabama's revision consists of provisions promulgated July 1, 2003, through June 30, 2004, otherwise known as RCRA Cluster XIV. The Alabama Department of Environmental Management adopted the rules for RCRA Cluster XIV effective March 31, 2005. We can now make an immediate final decision, subject to receipt of written comments that oppose this action, that Alabama's hazardous waste program revision satisfies all of the requirements necessary to qualify for Final authorization. Therefore, we grant Alabama Final authorization for the following program changes: Alabama Department of Environmental Administrative Code, Division 335-14, Hazardous Waste Program Regulations effective March 31, 2005. Description of Federal requirement Federal Register Analogous state authority Checklist 203, Recycled Used Oil Management Standards; Clarification July 30, 2003, 68 FR 44659-44665 335-14-2-.01(5)(j), 335-14-17.02, 335-14-17-.02(1)(i), 335-14-17-.08(5) Checklist 205, National Emission Standards for Hazardous Air Pollutants: Surface Coating of Automobiles and Light-Duty Trucks April 26, 2004, 69 FR 22602-22661 335-14-5-.28(1), 335-14-6-.28(1) H. Where Are the Revised State Rules Different From the Federal Rules? There are no State requirements in this program revision considered to be more stringent or broader in scope than the Federal requirements. I. Who Handles Permits After the Authorization Takes Effect? Alabama will issue permits for all the provisions for which it is authorized and will administer the permits it issues. EPA will continue to administer any RCRA hazardous waste permits or portions of permits which we issued prior to the effective date of this authorization until they expire or are terminated. We will not issue any more new permits or new portions of permits for the provisions listed in the Table above after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which Alabama is not yet authorized. J. What Is Codification and Is EPA Codifying Alabama's Hazardous Waste Program as Authorized in This Rule? Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. We do this by referencing the authorized State rules in 40 CFR part 272. We reserve the amendment of 40 CFR part 272, subpart B for this authorization of Alabama's program changes until a later date. K. Administrative Requirements The Office of Management and Budget

(OMB)has exempted this action from the requirements of Executive Order 12866 (58 FR 51735, October 4, 1993), and therefore this action is not subject to review by OMB. This action authorizes State requirements for the purpose of RCRA 3006 and imposes no additional requirements beyond those imposed by State law. Accordingly, I certify that this action 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 action authorizes 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). For the same reason, this action also does not significantly or uniquely affect the communities of Tribal governments, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely authorizes State requirements as part of the State RCRA hazardous waste program without altering the relationship or the distribution of power and responsibilities established by RCRA. This action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant and it does not make decisions based on environmental health or safety risks. 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) because it is not a significant regulatory action under Executive Order 12866. Under RCRA 3006(b), EPA grants a State's application for authorization as long as the State meets the criteria required by RCRA. It would thus be inconsistent with applicable law for EPA, when it reviews a State authorization application, to require the use of any particular voluntary consensus standard in place of another standard that otherwise satisfies the requirements of RCRA. 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. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. 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. 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 document 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 in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This action will be effective November 13, 2006. List of Subjects in 40 CFR Part 271 Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous waste, Hazardous waste transportation, Indian lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements. Authority: This action is issued under the authority of Sections 2002(a), 3006, and 7004(b), of the Solid Waste Disposal Act, as amended, 42 U.S.C. 6912(a), 6926, and 6974(b). Dated: August 31, 2006. A. Stanley Meiburg, Deputy Regional Administrator, Region 4. [FR Doc. E6-15201 Filed 9-12-06; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 15 [ET Docket No. 05-24; FCC 06-123] DTV Tuner Requirements AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: This document addresses a Petition for Reconsideration or Clarification of the Commission's *Second Report and Order* in this proceeding, submitted on behalf of PDI Communications Systems, Inc.

(PDI)and a subsequent Supplement to Petition for Clarification also filed on behalf of PDI in this same matter. DATES: Effective October 13, 2006. FOR FURTHER INFORMATION CONTACT: Alan Stillwell, Office of Engineering and Technology,

(202)418-2925, e-mail: *Alan.Stillwell@fcc.gov,* TTY

(202)418-2989. SUPPLEMENTARY INFORMATION: This is a summary of the Commission's *Order,* ET Docket No. 05-24, FCC 06-123, adopted August 15, 2006 and released August 17, 2006. The full text of this document is available on the Commission's Internet site at *http://www.fcc.gov.* It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing, Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone

(202)488-5300; fax

(202)488-5563; e-mail *FCC@BCPIWEB.COM.* Summary of the Order 1. The Commission addressed a Petition for Reconsideration or Clarification of the Commission's *Second Report and Order* in ET Docket No. 05-24, 70 FR 75739, December 21, 2005, submitted on behalf of PDI Communications Systems, Inc.

(PDI)and a subsequent Supplement to Petition for Clarification also filed on behalf of PDI in this same matter. In the *Second Report and Order* , the Commission amended its rules to advance to March 1, 2007 the date on which new broadcast television receivers with screen sizes 13-24″ and certain other broadcast TV receiving devices that do not have screens, such as VCRs and video recorders, must include the capability to receive broadcast digital television signals (DTV tuner requirement), and required new receivers with screen sizes smaller than 13″ to incorporate this capability on the same schedule. 2. PDI's request concerns the application of the DTV tuner requirement to new broadcast television receivers with screen sizes less than 13″, and specifically the application of that requirement to a specialized video system PDI manufactures and distributes for use in the healthcare industry. PDI asks that the Commission clarify the rules as adopted in the *Second Report and Order* to state that the DTV tuner requirement does not apply to the viewing units included in specialized video systems such as the PDI system. Alternately, it asks the Commission to modify its rules to provide on a case-by-case basis, waivers for viewing units used in specialized video systems when the application of the rule would not advance the Commission's stated objectives in the *Second Report and Order.* 3. Upon examining PDI's petition, supplemental filing, and the accompanying attachments, the Commission concludes that the viewing units in PDI's video system are television broadcast receivers as defined in Section 15.3(w) of the Commission's rules to which the DTV tuner requirement applies. In this regard, the Commission observes that the petition indicates that the PDI viewing units can be used to receive off-the-air signals. We further observe that the user manuals for the PERSONA 9 and PERSONA 10 viewing unit models specifically indicate that the units' channel setup features are configured to autoprogram for reception of “air” signals. In the broadcast reception mode, the cable providing both program signals and power connects to an antenna through the central system. The design feature by which the off-the-air signals are routed through the central system does not alter the fact that the video units can receive signals off-the-air (and apparently in some instances are used for that purpose). 4. The Commission does not find merit in PDI's argument that requiring its viewing units to include DTV tuners would not advance the Commission's goals in applying that requirement to smaller screen receivers. In the *Second Report and Order,* the Commission stated that, as it observed in first adopting the DTV tuner requirement, consumers must be able to receive digital TV signals for the DTV transition to move forward to a successful completion. To that end, the Commission's goal is to maximize the number of TV receivers on the market, with a final goal that all new television receiver products include a tuner as quickly as possible. While the PDI viewing units are different than most TV receivers with screens smaller than 13″ in that they are designed to receive service from a separate antenna connected through a cable rather than an attached antenna, that does not alter the fact that the PDI units would not be able to receive off-the-air TV signals when analog TV service ends unless they include a DTV tuner. 5. If the PDI viewing units are not able to receive digital TV service after the transition ends, those patients who view off-the-air TV signals on them, as well as the health care providers who own and operate the systems, will lose the benefits of that service. In this regard, the Commission recognizes that when analog TV service ends those PDI systems that are configured with analog only viewing units will not be able to offer off-the-air TV service. Applying the DTV tuner requirement to new viewing units will include the PDI systems in the transition process and minimize the number of viewing units that will need to be replaced when analog service ends. Therefore, the Commission will not exempt viewing units that are included in specialized video systems as described by PDI from the DTV tuner requirement. 6. The Commission also concludes that it would be inconsistent with these goals to establish a process that would provide for favorable treatment of requests for waiver of the DTV tuner requirement for TV receivers used in specialized video systems. As indicated, the Commission believes it is important to ensure that new TV receiver products include DTV reception as soon as possible. 7. The Commission recognizes PDI's position that the process for meeting the safety requirements for equipment used in medical facilities, coupled with PDI's position as a smaller manufacturer, may pose difficulties for PDI in meeting the March 1, 2007 effective date when all new TV receivers must comply with the DTV tuner requirement. In view of these circumstances, and pursuant to PDI's request that the Commission provide for a waiver of the rules in such cases, we find that a limited waiver of the DTV tuner requirement under the provisions of Section 1.3 is warranted to allow PDI additional time to bring the existing models of its viewing units into compliance. In this limited case of receivers used as part of a system intended for use in health care facilities, the Commission finds that providing an additional year for PDI Communications to bring its existing video system viewing unit models into compliance would serve the public interest without otherwise compromising its goals for ensuring that consumers are able to view broadcasters' digital television signals. 8. The Commission therefore denies PDI Communications Systems, Inc.'s requests that it:

(1)Determine that the DTV reception requirement in § 15.117(i) of the Commission's rules does not apply to its video system or

(2)modify its rules to provide a waiver procedure by which parties may seek a waiver of the March 1, 2007 effective date of that requirement for monitors used in specialized video systems. The Commission, however, is extending the date on which new units of the PERSONA 9 (Model PDI-P9TV) and PERSONA 10 (Model PDI-P10-LCD) viewing unit components of the PDI video system must comply with the DTV tuner requirement to March 1, 2008. That is, PDI Communications System, Inc. may continue to import and/or ship in interstate commerce units of its PERSONA 9 and PERSONA 10 viewing units that do not include the capability to receive broadcast television signals until February 28, 2008; on March 1, 2008 and thereafter new units of those products that are imported or shipped in interstate commerce must comply with the DTV tuner requirement. Ordering Clause 9. The Congressional Review Act

(CRA)was addressed in the Second Report and Order released by the Commission, November 8, 2005, in “In the Matter of Requirements for Digital Television Receiving Capability, in this proceeding, FCC 05-190, 70 FR 75739, December 21, 2005. This Order does not change any rules it only extends the date on which new units of the PERSONA 9 (Model PDI-P9TV) and PERSONA 10 (Model PDI-P10-LCD) viewing unit components of the PDI video system must comply with the DTV tuner requirement to March 1, 2008. 10. Pursuant to the authority contained in sections 2(a), 4(i) and (j), 7, 151, and 303 of the Communications Act of 1934, as amended, 47 U.S.C. 152(a), 154(i) and (j), 157, 303, and 405, and sections 1.3 and 1.106 of the Commission's rules, 47 CFR 1.3 and 1.106, the Petition for Reconsideration or Clarification submitted by John S. Logan on behalf of PDI Communications, Inc. is denied in part and granted in part. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E6-15067 Filed 9-12-06; 8:45 am] BILLING CODE 6712-01-P 71 177 Wednesday, September 13, 2006 Proposed Rules SOCIAL SECURITY ADMINISTRATION 20 CFR Part 401 RIN 0960-AE88 Privacy and Disclosure of Official Records and Information AGENCY: Social Security Administration. ACTION: Proposed rules. SUMMARY: We are proposing to revise our privacy and disclosure rules to clarify certain provisions and to provide expanded regulatory support for new and existing responsibilities and functions. These changes in the regulations will increase Agency efficiency and ensure consistency in the implementation of the Social Security Administration's

(SSA)policies and responsibilities under the Privacy Act and the Social Security Act. DATES: To be sure that your comments are considered, we must receive them no later than November 13, 2006. ADDRESSES: You may give us your comments by: the Federal eRulemaking Portal: *http://www.regulations.gov;* e-mail to *regulations@ssa.gov;* telefax to

(410)966-2830; or letter to the Commissioner of Social Security, P.O. Box 17703, Baltimore, MD 21235-7703. You may also deliver them to the Office of Regulations, Social Security Administration, 107 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, between 8 a.m. and 4:30 p.m. on regular business days. Comments are posted on our Internet site, or you may inspect them on regular business days by making arrangements with the contact person shown in this preamble. FOR FURTHER INFORMATION CONTACT: Christine W. Johnson, Office of Public Disclosure, 3 A-6 Operations Building, 6401 Security Boulevard, Baltimore, MD 21235-6401,

(410)965-8563 or TTY

(410)965-5609. For information on eligibility or filing for benefits, call our national toll-free numbers, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet Web site, Social Security Online, at *http://www.socialsecurity.gov.* SUPPLEMENTARY INFORMATION: Electronic Version The electronic file of this document is available on the date of publication in the **Federal Register** at *http://www.gpoaccess.gov/FR/index.html.* It is also available on the Internet site for the Social Security Administration (e.g., Social Security Online) at *http://policy.ssa.gov/pnpublic.nsf.LawsRegs.* Background We last revised the privacy and disclosure regulations in 1980 when the Social Security Administration

(SSA)was a part of the Department of Health and Human Services

(DHHS)(formerly the Department of Health, Education and Welfare) and subject to DHHS' disclosure policy oversight. Since 1980, significant changes have occurred in the procedures. We propose to codify these changes in the procedures governing access to, and disclosure of, personally identifiable information. We are also proposing to make minor housekeeping changes to further clarify our procedures. In general, the proposed changes reflect SSA's compliance with technological, legal and legislative changes that have occurred since 1980. Thus, we propose to clarify the provisions regarding requests for access to information developed by medical sources for Social Security programs, fully describe the existing responsibilities and functions of the Privacy Officer position, establish the new senior agency official for privacy as required by the Office of Management and Budget

(OMB)and explain the related responsibilities, and implement SSA's new Privacy Impact Assessment process in accordance with the E-Government Act of 2002, Pub. L. 107-347. Further, as required by OMB, we propose to require adequate safeguards against inappropriate disclosure of personal information by electronic means, e.g., over the Internet, and revise our procedures on notification of, or access to, medical records on behalf of another person, e.g., an adult or child. These proposed rules would also clarify SSA's policy concerning an individual's access to, or notification of, program records, amend the language concerning appeal requests under the Privacy Act to include denial of access to the record, and amend the language to insert the word “written” prior to “consent” to clarify that the requirement means disclosure with written consent and expand the language to more clearly define what information we will disclose with written consent. Further, we propose to revise the language to show that SSA also has physical custody of personnel records, and revise the language under disclosure of personal information in nonprogram records to show the new name of the former General Accounting Office. These proposed rules would also amend the language under disclosure of personal information in program records to make clear that we disclose information from program records only when there is a legitimate need for the information, and revise the language under disclosures required by law to show the current name for Aid to Families with Dependent Children. We also propose to amend the language under compatible purposes to clearly state how we implement the routine use provision of the Privacy Act (5 U.S.C. 552a(b)(3)) and what we mean by routine use in terms of the information we can disclose, and amend the language under law enforcement purposes to clarify that disclosures under 5 U.S.C. 552a(b)(7) also require a written request. Further, we propose to amend the language under statistical and research activities to reflect the language in the new routine use of data for research purposes, amend the language in the General Accounting Office section to correctly reflect the new name of the agency, and clarify certain matters related to our rules on disclosure under court order and other legal process. Explanation of Changes Section 401.20 Scope We propose to amend the section heading in § 401.20(a) to read “Access” and to amend paragraph

(a)to clarify the rules regarding the access provision as it pertains to information developed by medical sources that perform consultative examinations for us. We also propose to amend the heading in § 401.20(b)(1)(iii) to read “Records kept by medical sources,” and amend the language in that paragraph. Section 401.30 Privacy Act Responsibilities We propose to add new paragraphs (d),

(e)and

(f)to § 401.30. Privacy Officer New § 401.30(d) will fully describe the position of the SSA Privacy Officer and the responsibilities and functions of that position. SSA has always had a designated Privacy Officer since the enactment of the Privacy Act in 1974. Since that time, the Privacy Officer has overall responsibility for coordination of SSA privacy matters within the Agency. As such, the Privacy Officer advises the Agency on privacy policy matters and is responsible for developing and implementing privacy policies and related requirements, ensures compliance with the Privacy Act, and provides general oversight of privacy and disclosure policy involving privacy and disclosure matters. The Privacy Officer has other responsibilities including evaluating legislative proposals and other initiatives proposed by Congress, other agencies and the public, and reviewing multifunctional projects, studies and research activities involving personal information. The responsibilities also include facilitating the incorporation of privacy principles into information technology systems architectures and technical designs to ensure that privacy policies and practices are properly reflected in our business requirements. We are proposing to provide an explanation of the Privacy Officer's responsibilities to emphasize SSA's long-standing commitment to the public that personal information maintained in SSA's Privacy Act systems of records is handled in full compliance with the law. Senior Agency Official for Privacy To help protect the privacy rights of Americans and to ensure that agencies continue to have effective information privacy management programs in place to carry out this important responsibility, OMB requires that each agency designate a senior agency official to serve as the person in charge of privacy issues. The Senior Agency Official for Privacy will have overall responsibility and accountability for privacy issues at the national and agency-wide levels. The official will also have a central role in overseeing agency compliance efforts in privacy policy procedures as well as a key role in policy-making as it pertains to the development and evaluation of legislative, regulatory and other policy proposals that might implicate privacy issues. New § 401.30(e) will establish SSA's Senior Agency Official for Privacy and fully describe the responsibilities of that position as prescribed by OMB. (See OMB Memorandum M-08-05, dated February 11, 2005). Privacy Impact Assessments In accordance with Section 208 of the E-Government Act of 2002 (Pub. L. 107-347, 44 U.S.C. Ch. 36), the Office of Management and Budget now requires that certain Information Technology

(IT)projects receive a special privacy review called a Privacy Impact Assessment (PIA). The PIA review is in addition to the current SSA requirement that SSA's Privacy Officer certify Agency procurement requests for automated data processing resources and proposed contracts. The PIA review will strengthen the existing process by incorporating privacy involvement directly into the development of the IT system lifecycle and establishing a process that the entire Agency can understand in terms of privacy involvement in IT system development efforts. New § 401.30(f) will describe the PIA requirements for ensuring that privacy considerations receive a standardized review. We will determine if adequate measures have been taken to protect the privacy of the personally identifiable information the IT project will affect and if the requirements of the Privacy Act and applicable SSA regulations and policy are properly addressed. Section 401.45 Verifying Your Identity We propose to add to § 401.45 new paragraphs (b)(3) and (b)(4) to emphasize that when SSA provides convenient service to you over open computer networks such as the Internet, we will adequately protect against improper disclosure of records. We will redesignate present paragraphs (b)(3), (b)(4) and (b)(5) as (b)(5), (b)(6) and (b)(7), respectively. We will also revise the language in redesignated (b)(5). Increasingly, computer technology enables us to transact business with you as a taxpayer, Social Security beneficiary, employer or third-party organization. We will move cautiously to allow you to communicate with us securely over open networks such as the Internet. Such expanded services are dependent on our development of practices and mechanisms to ensure identity confirmation to protect you against improper disclosure of the personal information we maintain in our records, and to improve privacy protections. Section 401.55 Special Procedures for Notification of or Access to Medical Records We propose to revise the section heading to read “Access to medical records.” We also propose to revise the procedures for access to medical records to conform to the practices and systems of records that set out special procedures under which individuals may have direct access to their medical records. Currently, when you request your medical records, § 401.55(b)(1)(ii) requires you to designate a representative to receive the records for you and gives the representative the discretion to inform you about the contents of your record. We propose to modify the special procedures in that paragraph to require the representative to release your record to you after the discussion of its contents. The representative no longer has the discretion to withhold any part of your record. Section 401.55(c)(2)(iii) currently gives a designated representative (e.g., family physician or other health care professional) discretion about making the contents of a minor's medical record available to the parent or legal guardian. The proposed rule would modify this provision to require the representative to release the minor's records to the parent or legal guardian following the discussion of its contents. Additionally, we are redesignating present paragraph

(d)concerning requests on behalf of incapacitated adults as paragraph (c)(3). Section 401.60 Access or Notification of Program Records About Two or More Individuals Currently, § 401.60 is entitled “Access or notification of program records about two or more individuals.” The first sentence in the section reads “When information about two or more individuals is in one record filed under your social security number, you may receive the information about you and the fact of entitlement and the amount of benefits payable to other persons based on your record.” We propose to amend § 401.60 by inserting the word “to” after the word “Access” in the heading and revising the language in both the heading and first sentence to read “about more than one individual.” Section 401.70 Appeals of Refusals to Correct or Amend Records Currently, § 401.70 is entitled “Appeals of refusals to correct or amend records.” We propose to amend the section heading to include appeals after denial of access. We also propose to clarify the policy in the section by revising the language in existing paragraphs (a),

(b)and (c). Further, we propose to add a new paragraph

(d)to clearly explain the process after you file your appeal. Section 401.100 Disclosure of Records With the Consent of the Subject of the Record We propose to amend the language in the section heading under § 401.100 to insert the word “written” before “consent.” We also propose to revise the language in paragraph

(a)to clarify that the consent must be in writing and define what information we will disclose with written consent. To present the information in a more reader-friendly format, the second and third sentences of paragraph

(a)will be designated as new paragraphs

(b)“Disclosure with written consent”, and

(c)“Disclosure of the entire record,” respectively. We propose to make conforming changes to existing paragraph

(b)and redesignate it as paragraph (d). Section 401.105 Disclosure of Personal Information Without the Consent of the Subject of the Record We propose to revise the second sentence of paragraph

(b)into two sentences to clarify that SSA also has physical custody of personnel records maintained as part of the Office of Personnel Management's

(OPM)Privacy Act government-wide systems of records and that these records are subject to OPM's rules on access and disclosure at 5 CFR parts 293 and 297. Section 401.110 Disclosure of Personal Information in Nonprogram Records Without the Consent of the Subject of the Record We propose to amend the language in § 401.110

(j)to show the new name for the former General Accounting Office. Section 401.115 Disclosure of Personal Information in Program Records Without the Consent of the Subject of the Record We propose to amend the introductory language in § 401.115 to make clear that the information in program records will be disclosed only on a need-to-know basis. Section 401.120 Disclosure Required by Law Currently, the last sentence in § 401.120 reads “* * * and to Federal, State and local agencies administering Aid to Families with Dependent Children, Medicaid, unemployment compensation, food stamps, and other programs.” We propose to amend the language to reflect the current name of the AFDC program. The new name will read “* * * Temporary Assistance for Needy Families * * *.” Section 401.150 Compatible Purposes We propose to amend § 401.150 to clearly state how we implement the routine use provision. More specifically, the language in paragraphs

(a)and

(b)will be expanded to include what we mean by “routine use” in terms of the information we can disclose and how we give notice of routine use disclosures, respectively. We will amend paragraph

(c)by adding new paragraphs (c)(1) and (c)(2) to clearly show the distinctions between disclosure in SSA programs and programs similar to SSA programs, for compatibility purposes. Section 401.155 Law Enforcement Purposes We propose to amend § 401.155 to make clear that the Privacy Act requires a written request for information from the head of the law enforcement agency in situations involving both serious crimes and criminal activity involving Social Security programs or other programs with the same purpose. Section 401.165 Statistical and Research Activities We propose to amend § 401.165 to make it consistent with the recently published new routine use of data for research purposes. Section 401.175 General Accounting Office We propose to amend the section heading in § 401.175 to reflect a name change. The new heading will read “Government Accountability Office.” We also propose to revise the language in the paragraph to read “* * * to the Government Accountability Office when that agency needs the information to carry out its duties.” Section 401.180 Courts We propose to revise the entire section of § 401.180 to clarify our policy on disclosure when we receive an order from a court of competent jurisdiction. In 1980, when § 401.180 was initially published as a final rule, the status of subpoenas and other legal process under paragraph (b)(11) of the statute was unclear. Since then, SSA has not treated a subpoena or similar legal process as a court order unless a judge signs it. We believe that this position is now established as law as it is consistent with court decisions and OMB guidance interpreting the Privacy Act. See, e.g., *Doe* v. *DiGenova,* 779 F.2d 74 (D.C. Cir. 1985); *Stiles* v. *Atlanta Gas Light Co.,* 453 F.Supp. 798 (N.D. Ga. 1978). Therefore, we propose to revise § 401.180 as follows: In paragraph

(a)we will make clear that when information disclosed from SSA records is used in court proceedings, it usually becomes part of the public record of the proceedings and its confidentiality often cannot be protected. Accordingly, we will follow the rules in new paragraph

(d)of this section in deciding whether an order is from a court of competent jurisdiction. We propose to change the heading in paragraph

(b)to read “Court” and amend the language in the paragraph to state SSA's position that a court, for purposes of 5 U.S.C. § 552a(b)(11), is an institution of a judicial branch of government consisting of one or more judges who seek to adjudicate disputes and administer justice. The definition clarifies that other entities in other branches of government or not in the United States are not courts for purposes of the Privacy Act. We propose to add a new paragraph

(c)to explain that only a legal process, such as a summons or warrant, that is signed by a judge and that commands the disclosure of information by SSA will be considered to be a court order for purposes of the statutory exception in 5 U.S.C. § 552a(b)(11). References to subpoenas would be removed from this regulation. When we receive legal process that is not an order of a court of competent jurisdiction, (such as a grand jury subpoena, a subpoena signed by the clerk of the court or the attorney representing a party to the proceeding), we may decide to disclose information if the conditions described in any other provision of this regulation would permit the disclosure (for example, for a compatible purpose under § 401.150). However, we will not disclose without an order from a court of competent jurisdiction if the Privacy Act or any other law would prohibit the disclosure without such an order. We will also add a new paragraph

(d)to explain our view on court of competent jurisdiction. In new paragraph

(e)we propose to describe the conditions for disclosure under court order and clarify the rules on disclosure when a court order is involved. We propose to add a new paragraph

(f)to explain that in other circumstances we may attempt to satisfy the needs of a court of competent jurisdiction when the circumstances in paragraph

(e)are not met. We will make these determinations in accordance with § 401.140. We propose to add new paragraph

(g)to explain that we will treat a state criminal court as a court of competent jurisdiction in the limited circumstance when a disclosure is necessary to preserve the rights of an accused individual to due process in a criminal proceeding. We view that extending this exception to a state court hearing criminal matters does not in any way waive sovereign immunity. We are including this provision to clarify SSA's position that SSA should balance an individual's constitutional right to due process while preserving the confidentiality of information. SSA will disclose information when it believes the due process right outweighs the need to preserve confidentiality. We expect the court order to include language articulating the due process need for the information. Further, we propose to add a new paragraph

(h)to provide a cross-reference to additional regulations contained in 20 CFR part 403 concerning testimony and production of records in legal proceedings. Regulatory Procedures Executive Order 12866 The Office of Management and Budget has reviewed these proposed rules in accordance with Executive Order 12866, as amended by Executive Order 13258. Regulatory Flexibility Act We certify that these proposed rules would not have a significant economic impact on a substantial number of small entities because they affect only individuals or entities acting on their behalf. Thus, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required. Paperwork Reduction Act These proposed rules contain reporting requirements as shown in the table below. Where the public reporting burden is accounted for in Information Collection Requests for the various forms that the public uses to submit the information to SSA, a 1-hour placeholder burden is being assigned to the specific reporting requirement(s) contained in these rules. Section Annual number of responses Frequency of response Average burden per response (minutes) Estimated annual burden (hours) 401.45(b) 20,000 1 10 3333 401.70(a),

(b)1 401.100(b) 1 Total 20,000 1 10 3335 An Information Collection Request has been submitted to OMB for clearance. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility and clarity; and on ways to minimize the burden on respondents, including the use of automated collection techniques or other forms of information technology. Comments should be submitted and/or faxed to the Office of Management and Budget and the Social Security Administration at the following addresses/numbers: Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202-395-6974. Social Security Administration, Attn: SSA Reports Clearance Officer, Rm. 1338 Annex Building, 6401 Security Boulevard, Baltimore, MD 21235-6401, Fax Number: 410-965-6400. Comments can be received for up to 60 days after publication of this notice and will be most useful if received within 30 days of publication. To receive a copy of the OMB clearance package, you may call the SSA Reports Clearance Officer on 410-965-0454. (Catalog of Federal Domestic Assistance Program Nos. 96.001 Social Security—Disability Insurance; 96.002 Social Security—Retirement Insurance; 96.004 Social Security—Survivors Insurance; 96.006 Supplemental Security Income) List of Subjects in 20 CFR Part 401 Information, Records, Administrative practice and procedure, Archives and records. Dated: September 5, 2006. Jo Anne B. Barnhart, Commissioner of Social Security. For the reasons set out in the preamble, we are proposing to amend subparts A, B and C of part 401 of chapter III of title 20 of the Code of Federal Regulations as set forth below: PART 401—PRIVACY AND DISCLOSURE OF OFFICIAL RECORDS AND INFORMATION 1. The authority citation for part 401 continues to read as follows: Authority: Secs. 205, 702(a)(5), 1106, and 1141 of the Social Security Act (42 U.S.C. 405, 902(a)(5), 1306, and 1320b-11); 5 U.S.C. 552 and 552a; 8 U.S.C. 1360; 26 U.S.C. 6103; 30 U.S.C. 923. 2. Section 401.20 is amended by revising paragraphs

(a)and (b)(1)(iii) to read as follows: § 401.20 Scope.

(a)*Access.* Sections 401.30 through 401.95, which set out SSA's rules for implementing the Privacy Act, apply to records retrieved by an individual's name or personal identifier subject to the Privacy Act. The rules in §§ 401.30 through 401.95 also apply to information developed by medical sources for the Social Security program and shall not be accessed except as permitted by this part.

(b)* * *

(1)* * *

(iii)*Records kept by medical sources.* Information retained by medical sources pertaining to a consultative examination performed for the Social Security program shall not be disclosed except as permitted by this part. 3. Section 401.30 is amended by adding paragraphs (d),

(e)and

(f)to read as follows: § 401.30 Privacy Act responsibilities.

(d)*Privacy Officer.* The Privacy Officer is an advisor to the Agency on all privacy policy and disclosure matters. The Privacy Officer coordinates the development and implementation of Agency privacy policies and related legal requirements to ensure Privacy Act compliance, and monitors the coordination, collection, maintenance, use and disclosure of personal information. The Privacy Officer also ensures the integration of privacy principles into information technology systems architecture and technical designs, and generally provides to Agency officials policy guidance and directives in carrying out the privacy and disclosure policy.

(e)*Senior Agency Official for Privacy.* The Senior Agency Official for Privacy assumes overall responsibility and accountability for ensuring the agency's implementation of information privacy protections as well as agency compliance with Federal laws, regulations, and policies relating to the privacy of information, such as the Privacy Act. The compliance efforts also include reviewing information privacy procedures to ensure that they are comprehensive and up-to-date and, where additional or revised procedures may be called for, working with the relevant agency offices in the consideration, adoption, and implementation of such procedures. The official also ensures that agency employees and contractors receive appropriate training and education programs regarding the information privacy laws, regulations, polices and procedures governing the agency's handling of personal information. In addition to the compliance role, the official will have a central policy-making role in the agency's development and evaluation of legislative, regulatory and other policy proposals which might implicate information privacy issues, including those relating to the collection, use, sharing, and disclosure of personal information.

(f)*Privacy Impact Assessment.* In our comprehensive Privacy Impact Assessment

(PIA)review process, we incorporate the tenets of privacy law, SSA privacy regulations, and privacy policy directly into the development of certain Information Technology projects. Our review examines the risks and ramifications of collecting, maintaining and disseminating information in identifiable form in an electronic information system and identifies and evaluates protections and alternate processes to reduce the risk of unauthorized disclosures. As we accomplish the PIA review, we ask systems personnel and program personnel to resolve questions on data needs and data protection prior to the development of the electronic system. 4. Section 401.45 is amended by redesignating paragraphs (b)(3), (b)(4) and (b)(5) as (b)(5), (b)(6) and (b)(7), respectively, adding new paragraphs (b)(3) and (b)(4) and revising redesignated paragraph (b)(5) to read as follows: § 401.45 Verifying your identity.

(b)* * *

(3)*Electronic requests.* If you make a request by computer or other electronic means, e.g., over the Internet, we require you to verify your identity by using identity confirmation procedures that are commensurate with the sensitivity of the information that you are requesting. If we cannot confirm your identity using our identity confirmation procedures, we will not process the electronic request. When you cannot verify your identity through our procedures, we will require you to submit your request in writing.

(4)*Electronic disclosures.* When we collect or provide personally identifiable information over open networks such as the Internet, we use encryption in all of our automated online transaction systems to protect the confidentiality of the information. When we provide an online access option, such as a standard e-mail comment form on our Web site, and encryption is not being used, we alert you that personally identifiable information (such as your social security number) should not be included in your message.

(5)*Requests not made in person.* Except as provided in paragraphs (b)(2) of this section, if you do not make a request in person, you must submit a written request to SSA to verify your identify or you must certify in your request that you are the individual you claim to be. You must also sign a statement that you understand that the knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense. 5. Section 401.55 is amended by revising paragraphs (a), (b)(1)(ii), (c)(1) and (c)(2)(iii) and by redesignating paragraph

(d)as paragraph (c)(3) to read as follows: § 401.55 Access to medical records.

(a)*General.* You have a right to access your medical records, including any psychological information that we maintain.

(b)* * *

(1)* * *

(ii)When you request medical information about yourself, you must also name a representative in writing. The representative may be a physician, other health professional, or other responsible individual who will be willing to review the record and inform you of its contents. Following the discussion, you are entitled to your records. The representative does not have the discretion to withhold any part of your record. If you do not designate a representative, we may decline to release the requested information. In some cases, it may be possible to release medical information directly to you rather than to your representative.

(c)*Medical records of minors* —(1) *Request by the minor.* You may request access to your own medical records in accordance with paragraph

(b)of this section.

(2)*Request on a minor/s behalf.* * * *

(iii)Where a medical record on the minor exists, we will in all cases send it to the physician or health professional designated by the parent or guardian. The representative will review the record, discuss its contents with the parent or legal guardian, then release the entire record to the parent or legal guardian. The representative does not have the discretion to withhold any part of the minor's record. We will respond in the following similar manner to the parent or guardian making the request: We have completed processing your request for notification of or access to ____'s (Name of minor) medical records. Please be informed that if any medical record was found pertaining to that individual, it has been sent to your designated physician or health professional. 6. Section 401.60 is amended by revising the section heading and first sentence of the paragraph to read as follows: § 401.60 Access to or notification of program records about more than one individual. When information about more than one individual is in one record filed under your social security number, you may receive the information about you and the fact of entitlement and the amount of benefits payable to other persons based on your record. * * * 7. Section 401.70 is revised to read as follows: § 401.70 Appeals of refusals to correct records or refusals to allow access to records.

(a)*General.* This section describes how to appeal decisions made by SSA under the Privacy Act concerning your request for correction of or access to your records, those of your minor child or those of a person for whom you are the legal guardian. We generally handle a denial of your request for information about another person under the provisions of the Freedom of Information Act (see part 402 of this chapter). To appeal a decision under this section, your request must be in writing.

(b)*Appeal of refusal to correct or amend records.* If we deny your request to correct an SSA record, you may request a review of that decision. As discussed in § 401.65(e), our letter denying your request will tell you to whom to write.

(1)We will review your request within 30 working days from the date of the receipt. However, for a good reason and with the approval of the Executive Director for the Office of Public Disclosure, this time limit may be extended up to an additional 30 days. In that case, we will notify you about the delay, the reason for it and the date when the review is expected to be completed.

(2)If, after review, we determine that the record should be corrected, we will do so. However, if we refuse to amend the record as you requested, we will inform you that—

(i)Your request has been refused and the reason for refusing;

(ii)The refusal is SSA's final decision; and

(iii)You have a right to seek court review of SSA's final decision.

(3)We will also inform you that you have a right to file a statement of disagreement with the decision. Your statement should include the reason you disagree. We will make your statement available to anyone to whom the record is subsequently disclosed, together with a statement of our reasons for refusing to amend the record. Also, we will provide a copy of your statement to individuals whom we are aware received the record previously.

(c)*Appeals after denial of access.* If, under the Privacy Act, we deny your request for access to your own record, those of your minor child or those of a person to whom you are the legal guardian, we will advise you in writing of the reason for that denial, the name and title or position of the person responsible for the decision and your right to appeal that decision. You may appeal the denial decision to the Executive Director for the Office of Public Disclosure, 6401 Security Boulevard, Baltimore, MD 21235-6401, within 30 days after you receive notice denying all or part of your request, or, if later, within 30 days after you receive materials sent to you in partial compliance with your request.

(d)*Filing your appeal.* If you file an appeal, the Executive Director or his or her designee will review your request and any supporting information submitted and then send you a notice explaining the decision on your appeal. The time limit for making our decision after we receive your appeal is 30 working days. The Executive Director or his or her designee may extend this time limit up to 30 additional working days if one of the circumstances in 20 CFR 402.140 is met. We will notify you in writing of any extension, the reason for the extension and the date by which we will decide your appeal. The notice of the decision on your appeal will explain your right to have the matter reviewed in a Federal district court if you disagree with all or part of our decision. 8. Section 401.100 is revised to read as follows: § 401.100 Disclosure of records with the written consent of the subject of the record.

(a)*General.* Except as permitted by the Privacy Act and the regulations in this chapter, or when required by the FOIA, we will not disclose your records without your written consent.

(b)*Disclosure with written consent.* The written consent must clearly specify to whom the information may be disclosed, the information you want us to disclose (e.g., social security number, date and place of birth, monthly Social Security benefit amount, date of entitlement), and, where applicable, during which time frame the information may be disclosed (e.g., during the school year, while the subject individual is out of the country, whenever the subject individual is receiving specific services).

(c)*Disclosure of the entire record.* We will not disclose your entire record. For example, we will not honor a blanket consent for all information in a system of records or any other record consisting of a variety of data elements. We will disclose only the information you specify in the consent. We will verify your identity and where applicable (e.g., where you consent to disclosure of a record to a specific individual), the identity of the individual to whom the record is to be disclosed.

(d)A parent or guardian of a minor is not authorized to give written consent to a disclosure of a minor's medical record. See § 401.55 (c)(2) for the procedures for disclosure of or access to medical records of minors. 9. Section 401.105 is amended by revising the second sentence of paragraph

(b)to read as follows: § 401.105 Disclosure of personal information without the consent of the subject of the record.

(b)* * * For administrative and personnel records, we apply the Privacy Act restrictions on disclosure. To the extent that SSA has physical custody of personnel records maintained as part of the Office of Personnel Management's

(OPM)Privacy Act government-wide systems of records, these records are subject to OPM's rules on access and disclosure at 5 CFR parts 293 and 297. * * * 10. Paragraph

(j)of § 401.110 is revised to read as follows: § 401.110 Disclosure of personal information in nonprogram records without the consent of the subject of the record.

(j)To the Comptroller General, or any of his authorized representatives, in the course of the performance of duties of the Government Accountability Office. 11. Section 401.115 is amended by revising the introductory text to read as follows: § 401.115 Disclosure of personal information in program records without the consent of the subject of the record. This section describes how various laws control the disclosure or confidentiality of personal information that we keep. We disclose information in the program records only when a legitimate need exists. For example, we disclose information to officers and employees of SSA who have a need for the record in the performance of their duties. We also must consider the laws identified below in the respective order when we disclose program information: 12. Section 401.120 is amended by revising the last sentence in the paragraph to read as follows: § 401.120 Disclosures required by law. * * * These agencies include the Department of Veterans Affairs for its benefit programs, U.S. Citizenship and Immigration Services to carry out its duties regarding aliens, the Railroad Retirement Board for its benefit programs, and to Federal, State and local agencies administering Temporary Assistance for Needy Families, Medicaid, unemployment compensation, food stamps, and other programs. 13. Section 401.150 is revised to read as follows: § 401.150 Compatible purposes.

(a)*General.* The Privacy Act allows us to disclose information without your consent to any other party for routine uses. “Routine use” means that your information can be disclosed for use in any program that is compatible with the purpose for which SSA collected the information.

(b)*Notice of routine use disclosures.* A list of permissible routine use disclosures is included in every system of records notice published in the **Federal Register** .

(c)*Determining compatibility* —(1) *Disclosure to carry out SSA programs.* We disclose information for routine uses where necessary to carry out SSA's programs.

(2)*Disclosure to carry out programs similar to SSA programs.* We disclose information for routine uses in the administration of other government programs that have the same purposes as SSA programs and meet the following conditions:

(i)The program is clearly identifiable as a Federal, State, or local government program.

(ii)The information requested concerns eligibility, benefit amounts, or other matters of benefit status in a Social Security program and is relevant to determining the same matters in the other program. For example, we disclose information to the Railroad Retirement Board for pension and unemployment compensation programs, to the Department of Veterans Affairs for its benefit programs, to worker's compensation programs, to State general assistance programs and to other income maintenance programs at all levels of government. We also disclose for health maintenance programs like Medicaid and Medicare.

(iii)In appropriate cases, we will disclose information for use in epidemiological and similar research. 14. Section 401.155 is amended by adding a sentence between the fourth and fifth sentences in paragraph

(a)and by removing the last sentence of paragraph (b). § 401.155 Law enforcement purposes.

(a)*General.* * * * The Privacy Act allows us to disclose information if the head of the law enforcement agency makes a written request giving enough information to show that the conditions in paragraphs

(b)or

(c)of this section are met, what information is needed, and why it is needed. * * * 15. Section 401.165 is amended by revising paragraph (b)(2) to read as follows: § 401.165 Statistical and research activities.

(b)* * *

(2)The activity is designed to increase knowledge about present or alternative Social Security programs or other Federal or State income-maintenance or health-maintenance programs; or is used for research that is of importance to the Social Security program or the Social Security beneficiaries; or an epidemiological research project that relates to the Social Security program or beneficiaries; and 16. Section 401.175 is revised to read as follows: § 401.175 Government Accountability Office. We disclose information to the Government Accountability Office when that agency needs the information to carry out its duties. 17. Section 401.180 is revised to read as follows: § 401.180 Disclosure under court order or other legal process.

(a)*General.* The Privacy Act permits us to disclose information when we are ordered to do so by a court of competent jurisdiction. When information is used in a court proceeding, it usually becomes part of the public record of the proceeding and its confidentiality often cannot be protected in that record. Much of the information that we collect and maintain in our records on individuals is especially sensitive. Therefore, we follow the rules in paragraph

(d)of this section in deciding whether we may disclose information in response to an order from a court of competent jurisdiction. When we disclose pursuant to an order from a court of competent jurisdiction, and the order is a matter of public record, the Privacy Act requires us to send a notice of the disclosure to the last known address of the person whose record was disclosed.

(b)*Court.* For purposes of this section, a court is an institution of a judicial branch of government within the United States consisting of one or more judges who seek to adjudicate disputes and administer justice. Entities not in the judicial branch of government within the United States are not courts for purposes of this section.

(c)*Court order.* For purposes of this section, a court order is any legal process which satisfies all of the following conditions:

(1)It is issued under the authority of a court;

(2)A judge of that court signs it;

(3)It commands SSA to disclose information; and

(4)The court is a court of competent jurisdiction.

(d)*Court of competent jurisdiction.* It is the view of SSA that under the Privacy Act the Federal Government has not waived sovereign immunity, which precludes state court jurisdiction over a Federal agency or official. Therefore, SSA will not honor state court orders as an independent basis for disclosure except in the circumstances described in paragraph

(g)of this section. Other state court orders will be treated in accordance with the other provisions of this part.

(e)*Conditions for disclosure under a court order of competent jurisdiction.* We disclose information in compliance with an order of a court of competent jurisdiction if —

(1)Another section of this part specifically allows such disclosure, or

(2)SSA, the Commissioner of Social Security, or any officer or employee of SSA in his or her official capacity is properly a party in the proceeding, or

(3)Disclosure of the information is necessary to ensure that an individual who is accused of criminal activity receives due process of law in a criminal proceeding.

(f)*In other circumstances.* We may disclose information to a court of competent jurisdiction in circumstances other than those stated in paragraph

(e)of this section. We will make our decision regarding disclosure by balancing the needs of a court while preserving the confidentiality of information. For example, we may disclose information under a court order that restricts the use and redisclosure of the information by the participants in the proceeding; we may offer the information for inspection by the court *in camera* and under seal; or we may arrange for the court to exclude information identifying individuals from that portion of the record of the proceedings that is available to the public. We will make these determinations in accordance with section 401.140.

(g)*Conditions for disclosure under state court orders.* We may disclose information in compliance with a state court order only if the disclosure is necessary to preserve the rights of an accused to due process in a criminal proceeding. We will make our decision regarding disclosure by balancing the needs of a state court while preserving the confidentiality of information.

(h)*Other regulations on request for testimony, subpoenas and production of records in legal proceedings.* See 20 CFR part 403 of this chapter for additional rules covering disclosure of information and records governed by this part and requested in connection with legal proceedings. [FR Doc. E6-15101 Filed 9-12-06; 8:45 am] BILLING CODE 4191-02-P DEPARTMENT OF STATE 22 CFR Part 99 [Public Notice 5539] RIN: 1400-AC-20 Intercountry Adoption—Reporting on Non-Convention and Convention Adoptions of Emigrating Children AGENCY: Department of State. ACTION: Proposed rule. SUMMARY: The Department of State (the Department), with the joint review and approval of the Department of Homeland Security (DHS), is proposing a new rule to implement the requirement in the Intercountry Adoption Act of 2000 (the IAA) to establish a Case Registry for, *inter alia,* emigrating children. This proposed rule would impose reporting requirements on adoption service providers, including governmental authorities who provide adoption services, in cases involving adoptions of children who will emigrate from the United States. These reporting obligations apply to all intercountry adoptions, regardless of whether they are covered under the 1993 Hague Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption (the Convention). This proposed rule, although issued with the joint review and approval of DHS pursuant to section 303(d) of the IAA, only adds a new section to the Department's Convention regulations; no amendments or additions are made to DHS regulations. DATES: Comments must be received on or before November 13, 2006. ADDRESSES: You may submit comments, identified by docket number State/AR-01/99, by one of the following methods (no duplicates, please): • *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • *Electronically:* You may submit electronic comments to *adoptionregs@state.gov.* Attachments must be in Microsoft Word. • *Mail:* U.S. Department of State, CA/OCS/PRI, Adoption Regulations Docket Room, (SA-29), 2201 C Street, NW., Washington, DC 20520. • *Courier:* U.S. Department of State, CA/OCS/PRI, Adoption Regulations Docket Room, (SA-29), 2201 C Street, NW., Washington, DC 20520. (Because access to the Department of State is not readily available to private individuals without Federal Government identification, do not personally deliver comments to the Department). *Docket:* Comments received before the close of the comment period will be available to the public, including any personally identifiable information that is included in a comment. The Department posts comments on its public Web site at: *http://travel.state.gov* or they are available for public inspection by calling Delilia Gibson-Martin at 202-736-9105 for an appointment. FOR FURTHER INFORMATION CONTACT: Anna Mary Coburn at 202-736-9081. Hearing- or speech-impaired persons may use the Telecommunications Devices for the Deaf

(TDD)by contacting the Federal Information Relay Service at 1-800-877-8339. SUPPLEMENTARY INFORMATION: I. Legal Authority The Hague Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption, May 29, 1993, S. Treaty Doc. 105-51 (1998); 1870 U.N.T.S. 167 (Reg. No. 31922 (1993)), 32 I.L.M. 1134 (1993); Intercountry Adoption Act of 2000, 42 U.S.C. 14901-14954. II. Introduction The Convention is a multilateral treaty that provides a framework for the adoption of children habitually resident in one country that is a party to the Convention by persons habitually resident in another country that is also a party to the Convention. The Convention establishes procedures to be followed in these intercountry adoption cases and imposes safeguards to protect the best interests of children. It applies to the United States as both a country of origin (outgoing cases, *i.e.* , where children are emigrating from the United States to a foreign country) and a receiving country (incoming cases, *i.e.* , where children are immigrating to the United States from a foreign country). The implementing legislation for the Convention is the IAA. The IAA requires the Department and DHS to establish a Case Registry to track all intercountry adoption cases: Convention and non-Convention; emigrating and immigrating cases. It also requires the Department to report certain information about intercountry adoptions to Congress. To implement these responsibilities, the Department is, with the joint review and approval of DHS, promulgating this proposed rule to require adoption service providers who provide adoption services in intercountry adoption cases involving a child emigrating from the United States (including governmental authorities who provide such adoption services) to report certain information to the Department for incorporation into the Case Registry. These requirements would apply in both Convention and non-Convention cases involving emigrating children. No regulation is being proposed at this time to establish reporting requirements in cases involving children immigrating to the United States (incoming cases), because sufficient information can be collected through other means, primarily the DHS petition process and the immigration visa and issuance process. Separate regulations implement other aspects of the Convention and the IAA, such as regulations on the accreditation/approval of adoption service providers

(ASPs)to perform adoption services in cases covered by the Convention (22 CFR part 96), preservation of Convention records (22 CFR part 98), visa procedures for Convention adoption cases involving immigrating children (regulations to appear at 22 CFR part 42), and certification of Convention adoption proceedings done by U.S. courts (regulations to appear at 22 CFR part 97). Further background on the Convention and the IAA is provided in the Preamble to the Final Rule on the Accreditation and Approval of Agencies and Persons under the IAA, Section I and II, 71 FR 8064-8066 (February 15, 2006) and the Preamble to the Proposed Rule on the Accreditation of Agencies and Approval of Persons under the IAA, Section III and IV, 68 FR 54065-54073 (September 15, 2003). III. The Proposed Rule This proposed rule establishes reporting requirements for all intercountry adoption cases in which a child is emigrating from the United States. There are three IAA sections relevant to the development of this proposed rule. Section 102(e) of the IAA requires the Department and DHS to establish a Case Registry of all adoptions involving the immigration of children to the United States and emigration of children from the United States regardless of whether the adoption occurs under the Convention. This Case Registry must permit tracking of pending cases and retrieval of information on both pending and closed cases. (As noted previously, this proposed regulation addresses only emigrating (outgoing) cases, and not immigrating (incoming) cases, because the Department can obtain sufficient data on immigrating cases through other means.) Section 303(d) of the IAA requires all adoption service providers, including governmental authorities, who provide adoption services in outgoing cases not subject to the Convention, to file information required under regulations issued to implement the Case Registry. In addition, section 104 of the IAA requires the Department to submit annual reports to Congress on all intercountry adoptions, which must set forth, among other items, the total number of Convention and non-Convention outgoing cases, the country to which each child immigrated, and the State from which each child emigrated. In summary, these three sections of the IAA—section 102(a) (establishment of Case Registry), section 303(d)(filing with Case Registry regarding non-Convention adoptions), and section 104(b)(2) (annual reports to Congress)'provide the Department with the legal authority to collect the data outlined in the proposed rule. Although the main purpose of the IAA was to implement the Convention, Congress also sought to gather case-specific data on intercountry adoptions. Historically, children involved in outgoing cases did not require adoption-specific Federal services in connection with their departure from the United States and therefore were not identified as such to the Federal government. As noted, in the IAA, Congress mandated the creation of Case Registry to monitor all intercountry adoption cases, including both Convention and non-Convention outgoing cases. The House Committee on International Relations stated in its report on the IAA that “[T]his registry shall be for the purpose of easing administration of [the IAA] and the Convention so that Federal agencies and prospective adoptive parents can determine the status of a particular case and for the purpose of creating a system to track children who leave the United States to be adopted abroad.” (Report of the House Committee on International Relations on the Intercountry Adoption Act, 106th Cong. 2nd Sess., H.R. Rep. No 106-691 (2000)). With this legislative history and the resulting statutory language in mind, the Department has devised a rule that requires reporting of certain case-specific information both to permit tracking and retrieval of information on outgoing cases and to enable the Department to complete its annual reports to Congress. The proposed rule is narrowly crafted to include only those basic items necessary to fulfill these case tracking and reporting functions. Moreover, in the interest of increasing compliance, we have attempted to keep the requirements simple and the number of items to be reported very limited. Reporting Information on Convention and Non-Convention Outgoing Cases Section 99.1 of the proposed regulation defines the term “Convention” and adopts by reference all other definitions established in 22 CFR 96.2 (Hague accreditation and approval regulation). Section 99.2 of the proposed regulation sets forth the reporting requirements for providers of adoption services in outgoing (emigrating child) adoptions. Note that the term “adoption services” is a defined term in 22 CFR 96.2 and refers to the following six services:

(1)Identifying a child for adoption and arranging an adoption;

(2)securing the necessary consent to termination of parental rights and to adoption;

(3)performing a background study on a child or a home study on a prospective adoptive parent(s), and reporting on such a study;

(4)making non-judicial determinations of the best interests of a child and the appropriateness of an adoptive placement for the child;

(5)monitoring a case after a child has been placed with prospective adoptive parent(s) until final adoption;

(6)when necessary because of disruption before final adoption, assuming custody and providing (including facilitating the provision of) child care or any other social service pending an alternative placement. Post-adoption services are not included within the definition of “adoption services.” Who Must Report? Section 99.2(a) makes clear that any entity that provides adoption services will be required to report under this rule if it is a “reporting provider” in the case, as identified in § 99.2(b). This means that all agencies (whether or not accredited or temporarily accredited), all persons (whether or not approved), all public domestic authorities (a defined term in 22 CFR 96.2 which means an authority operated by a State, local, or tribal government within the United States), and any other providers of adoption services in outgoing adoption cases are potentially required to report under this regulation. To avoid duplicative reporting, and to reduce the burden on all adoption service providers, including public domestic authorities, § 99.2(b) establishes a framework for determining which provider must report in a given case as follows: *Convention cases.* In an outgoing Convention adoption case involving at least one accredited, temporarily accredited, or approved provider, it is the primary provider, as described in 22 CFR 96.14(a) that must report. In an outgoing Convention adoption in which there is no accredited, temporarily accredited, or approved provider involved, the public domestic authority performing adoption services in the case must report. *Non-Convention cases.* In an outgoing non-Convention adoption case, in which there is only one provider of adoption services, that provider must report. As noted above, this provider might be an agency (including an accredited agency or temporarily accredited agency), a person (including an approved person), a public domestic authority, or any other adoption service provider. In cases in which there are two or more providers of adoption services, the reporting provider is the provider that is responsible for child placement as determined by applying factors listed in § 99.2. When multiple providers are involved in a non-Convention case, each provider must use the factors in § 99.2 of the proposed rule to identify whether it is the provider with child placement responsibility and therefore must report the information listed in § 99.2(c) and (d). The language in § 99.2(b)(1) through

(4)is similar to the language in 22 CFR 96.14 on how to determine who is the primary provider; however, it has been adapted slightly to replace Convention specific terminology with language appropriate to non-Convention cases. This proposed rule does not require prospective adoptive parent(s) who are acting on their own behalf, as described in 22 CFR 96.13(d), to report information to the Department, even if they perform adoption services for themselves in an outgoing case. The Department is not including prospective adoptive parent(s) acting on their own behalf as potential reporters because, although they may perform adoption services on their own behalf, they are not providing adoption services to others, and thus section 303(d) of the IAA would not require them to report data to the Department. The Department believes that very few if any outgoing Convention adoption cases will be accomplished entirely by prospective adoptive parent(s) acting alone, since the requirements that must be met to achieve IAA and Convention compliance, as set forth in 22 CFR 97.3, will require the use of an adoption service provider. We also believe that, given the complexity of outgoing intercountry adoptions and the standard requirement of an independent home study, the number of non-Convention cases where there is no adoption service provider at all will be quite limited as well. What Information Must Be Reported? Section 99.2(c) and

(d)lists the case-specific information that must be reported to the Department. The Department has limited the data items to the minimum amount of information it believes necessary to carry out its statutory duties. The regulation divides required reporting into two basic categories: Identifying information that must be reported within 30 days of learning that the case involves emigration of a child from the United States to a foreign country, set forth in § 99.2(c), and milestone information as well as changes to information previously provided that must be reported within 30 days of occurrence, as set forth in § 99.2(d). In accordance with § 99.2(c), the reporting provider, as identified in § 99.2(b), must provide the following identifying information to the Department within 30 days of learning a case involves emigration of a child from the United States to a foreign country: • The name, date of birth of child, and place of birth of child; • The U.S. state from which the child is emigrating; • The foreign country to which the child is immigrating; • The U.S state where the final adoption is taking place, or alternatively, the U.S. State where legal custody for the purpose of adoption is being granted and the foreign country where the final adoption will take place; and • The name, address, phone number, and other contact information for the reporting provider. In addition, in accordance with § 99.2(d), the reporting provider must provide any changes to information previously provided, as well as the following milestone information, to the Department within 30 days of occurrence: • Date on which the case was determined to involve emigration from the United States. (Generally, this date would be the time the U.S. child is matched with foreign adoptive parents.) • Date of the U.S. final adoption or, alternatively, the date on which custody for purpose of adoption was granted in the United States; • Date of foreign final adoption if custody for purpose of adoption was granted in the United States, to the extent practicable; and • Any additional information when requested by the Department in a particular case. The proposed rule mandates that an adoption service provider report the initial information to the Department within 30 days of identifying that the case involves the emigration of a child from the United States, and subsequently within 30 days of each milestone or change to previously reported information. The proposed rule does not include details on the mechanics of how and where to report the information listed in § 99.2. The Department plans to post on its Web site instructions to adoption service providers on how and where to send the required basic information on a particular case. The Department and DHS Role Section 303(d) of the IAA envisioned that DHS and the Department would agree on a rule on reporting requirements needed for the Case Registry. The Department is currently developing the Case Registry and coordinating with DHS on the case-tracking functions for immigrating children. DHS has a substantial role in cases involving immigrating children. On the other hand, DHS is not directly involved in outgoing cases at all. Nevertheless, in keeping with section 303(d) of the IAA, 22 CFR part 99 was jointly reviewed and approved by the Department and DHS. However, the regulation only adds a new part to the Department's regulations at Title 22 of the Code of Federal Regulations. No changes are made to any DHS regulations, nor will the rule appear in Title 8 of the Code of Federal Regulations. IV. Regulatory Review: A. Administrative Procedures Act In accordance with provisions of the Administrative Procedure Act governing rules promulgated by Federal agencies that affect the public (5 U.S.C. 533), the Department is publishing this proposed rule and inviting public comment. All comments received before the close of business on the comment closing date indicated above will be considered and will be available for examination in the docket. Comments received after the comment closing date will be filed in the docket and will be considered to the extent practicable. A final rule may be published at any time after close of the comment period. B. Regulatory Flexibility Act/Executive Order 13272: Small Business In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-612 and Executive Order 13272, section 3(b), the Department of State has evaluated the effects of this proposed action on small entities, and has determined, and hereby certifies, pursuant to 5 U.S.C. 605(b), that it would not have a significant economic impact on a substantial number of small entities. As stated in the final rule for 22 CFR part 96 (71 FR 8064, 8128), the Department estimates that overall there are between 420 and 600 ASPs that may have to comply with the accreditation regulations, all of whom are likely to be small entities. However, overall, the number of outgoing intercountry adoption cases is expected to be very small in comparison with the number of incoming cases. Consequently, there will be very few ASPs who are small entities and who will also be involved in outgoing cases. The proposed rule requires only extremely limited reporting requirements for outgoing cases. Thus, the Department does not believe the economic impact on small entities will be significant; however, the Department welcomes public comment on the rule's impact on small entities and the cost of reporting requirements mandated by the IAA. C. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by 5 U.S.C. 804 for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121. The rule would not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, or innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. D. The Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995 (UFMA), Public Law 104-4; 109 Stat. 48; 2 U.S.C. 1532, generally requires agencies to prepare a statement, including cost-benefit and other analyses, before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year. Moreover, because this rule will not significantly or uniquely affect small governments, section 203 of the UFMA, 2 U.S.C. 1533, does not require preparation of a small government agency plan in connection with it. E. Executive Order 13132: Federalism A rule has federalism implications under Executive Order 13132 if it has substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. This regulation will not have such effects, and therefore does not have sufficient federalism implications to require consultations or to warrant the preparation of a federalism summary impact statement under section 6 of Executive Order 13132. The Convention and the IAA do, however, address issues that previously had been regulated primarily at the State level, as discussed in the preamble to the proposed rule on accreditation and approval of agencies and persons, appearing at 68 FR 54064, 54069-54070. These regulations do not create new federalism implications beyond those created by the IAA, and the Department has been careful to limit reporting duties of State, local, and tribal authorities to those necessitated by the IAA. We believe the burden of reporting the proposed information to the Department will be minimal. As with the regulations on accreditation and approval, the Department welcomes comments from State and local agencies and tribal governments on the proposed regulations. We also envision significant outreach and consultation with appropriate State authorities in the ultimate implementation of any regulation on this topic. F. Executive Order 12866: Regulatory Review The Department of State does not consider this rule to be a “significant regulatory action” within the scope of section 3(f)(1) of Executive Order 12866. Nonetheless, the Department has reviewed the rule to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Order. G. Executive Order 12988: Civil Justice Reform The Department has reviewed this rule in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. The Department has made every reasonable effort to ensure compliance with the requirements in Executive Order 12988. H. The Paperwork Reduction Act

(PRA)of 1995 Under the PRA, 42 U.S.C. 3501 *et seq.* , agencies are generally required to submit to the Office of Management and Budget

(OMB)for review and approval information collection requirements imposed on “persons” as defined in the PRA. Section 503(c) of the IAA exempts from the PRA information collection “for purposes of sections 104, 202(b)(4), and 303(d)” of the IAA “or for use as a Convention record as defined” in the IAA. All information collections that relate to outgoing non-Convention cases will be collections made for the purposes of section 303(d) of the IAA, and thereby exempt. All information collections that relate to outgoing Convention cases will be Convention records as defined in and subject to the preservation requirements of 22 CFR 98, which implements section 401(a) of the IAA. Additionally, the majority of information collection imposed on persons pursuant to this rule, with respect to both Convention and non-Convention cases, will be for the purposes of obtaining information for congressional reports required under section 104 of the IAA. Accordingly, the Department has concluded that the PRA does not apply to information collected from the public under this rule. List of Subjects in 22 CFR Part 99 Adoption and foster care; International agreements; Reporting and recordkeeping requirements. Accordingly, the Department proposes to add new part 99 to title 22 of the CFR, chapter I, subchapter J, to read as follows: PART 99—REPORTING ON CONVENTION AND NON-CONVENTION ADOPTIONS OF EMIGRATING CHILDREN Sec. 99.1 Definitions. 99.2 Reporting requirements for adoptions involving emigrating U.S. children. 99.3 [Reserved]. Authority: The Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption (done at The Hague, May 29, 1993), S. Treaty Doc. 105-51 (1998); 1870 U.N.T.S. 167 (Reg. No. 31922 (1993)); The Intercountry Adoption Act of 2000, 42 U.S.C. 14901-14954. § 99.1 Definitions. As used in this part, the term:

(a)*Convention* means the Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption done at The Hague on May 29, 1993.

(b)Such other terms as are defined in 22 CFR 96.2 shall have the meaning given to them therein. § 99.2 Reporting requirements for adoption cases involving emigrating U.S. children.

(a)An agency (including an accredited agency and temporarily accredited agency), person (including an approved person), public domestic authority, or other adoption service provider providing adoption services in a case involving the emigration of a child from the United States must report information to the Secretary in accordance with this section if it is identified as the reporting provider in accordance with paragraph

(b)of this section.

(b)In a Convention case in which an accredited agency, temporarily accredited agency, or approved person is providing adoption services, the primary provider is the reporting provider. In any other Convention case, or in a non-Convention case, the reporting provider is the agency, person, public domestic authority, or other adoption service provider that is providing adoption services in the case, if it is the only provider of adoption services. If there is more than one more provider of adoption services in a non-Convention case, the reporting provider is the one that has child placement responsibility, as evidenced by the following factors:

(1)Entering into placement contracts with prospective adoptive parent(s) to provide child referral and placement;

(2)Accepting custody from a birthparent or other legal guardian for the purpose of placement for adoption;

(3)Assuming responsibility for liaison with a foreign government or its designees with regard to arranging an adoption; or

(4)Receiving from or sending to a foreign country information about a child that is under consideration for adoption.

(c)A reporting provider, as identified in paragraph

(b)of this section, must report the following identifying information to the Secretary for each outgoing case within 30 days of learning that the case involves emigration of a child from the United States to a foreign country:

(1)Name, date of birth of child, and place of birth of child;

(2)The U.S. State from which the child is emigrating;

(3)The country to which the child is immigrating;

(4)The U.S. State where the final adoption is taking place, or the U.S. State where legal custody for the purpose of adoption is being granted and the country where the final adoption is taking place; and

(5)Its name, address, phone number, and other contact information.

(d)A reporting provider, as identified in paragraph

(b)of this section, must report any changes to information previously provided as well as the following milestone information to the Secretary for each outgoing case within 30 days of occurrence:

(1)Date case determined to involve emigration from the United States (generally the time the U.S. child is matched with foreign adoptive parents);

(2)Date of U. S. final adoption or date on which custody for the purpose of adoption was granted in United States;

(3)Date of foreign final adoption if custody for purpose of adoption was granted in the United States, to the extent practicable; and

(4)Any additional information when requested by the Secretary in a particular case. § 99.3 [Reserved] Dated: June 15, 2006. Maura Harty, Assistant Secretary, Bureau of Consular Affairs, Department of State. Dated: August 30, 2006. Michael Chertoff, Secretary of Homeland Security, Department of Homeland Security. [FR Doc. 06-7526 Filed 9-12-06; 8:45 am]

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