9–20–07 Thursday Vol. 72 No. 182 Sept. 20, 2007

Pages 53673–53912

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Contents Federal Register Vol. 72, No. 182

Thursday, September 20, 2007

Agriculture Department Environmental Protection Agency See Food Safety and Inspection Service RULES Air quality implementation plans; approval and Alcohol and Tobacco Tax and Trade Bureau promulgation; various States: PROPOSED RULES Delaware, 53686–53687 PROPOSED RULES Alcoholic beverages: Air pollutants, hazardous; national emission standards: Wines, distilled spirits, and malt beverages; labeling and Clay ceramics manufacturing, glass manufacturing, and advertising— secondary nonferrous metals processing, 53838– Alcohol content statement, 53742–53743 NOTICES 53870 Agency information collection activities; proposals, Electric arc furnace steelmaking facilities, 53814–53836 submissions, and approvals, 53811 Air quality implementation plans; approval and promulgation; various States; air quality planning purposes; designation of areas: Children and Families Administration California, 53743–53744 NOTICES NOTICES Grants and cooperative agreements; availability, etc.: Air pollution control: Low Income Home Energy Assistance Program, 53774 Citizen suits; proposed settlements— American Iron and Steel Institute et al., 53769–53770 Commerce Department Center for Biological Diversity et al., 53768–53769 See National Oceanic and Atmospheric Administration Federal Aviation Administration See Patent and Trademark Office RULES Maintenance, preventive maintenance, rebuilding, and Commodity Futures Trading Commission alteration: NOTICES Major repairs and alterations; recording requirements, Meetings; Sunshine Act, 53754–53755 53678–53680 Standard instrument approach procedures, 53680–53684 Defense Department PROPOSED RULES RULES Airworthiness directives: Civilian health and medical program of uniformed services Airbus, 53699–53701 (CHAMPUS): Boeing, 53701–53704, 53706–53709 TRICARE program— Bombardier, 53704–53706 Dental Program; National Defense Authorization Act Fokker, 53709–53711 changes, 53685 NOTICES NOTICES Aeronautical land-use assurance; waivers: Meetings; Sunshine Act, 53755 Pellston Regional Airport, MI, 53808–53810 Federal Communications Commission Drug Enforcement Administration RULES PROPOSED RULES Radio stations; table of assignments: Controlled substances; manufacturers, distributors, and Arizona and New Mexico, 53688 dispensers; registration: Indiana, 53687–53688 Maintenance or detoxification treatment; approved New Mexico, 53688 narcotic controlled substances dispensed or NOTICES prescribed by qualified individual practitioners Agency information collection activities; proposals, Patient limitation changes, 53734–53736 submissions, and approvals, 53771–53772 NOTICES Combat Methamphetamine Epidemic Act; implementation: Federal Highway Administration Ephedrine, pseudoephedrine, and PROPOSED RULES phenylpropanolamine— Automated toll collection systems; interoperability List I 2007 annual needs assessment, 53908–53911 requirements, standards, or performance specifications, List I 2008 annual needs assessment, 53911–53912 53736–53742 Applications, hearings, determinations, etc.: NOTICES Applied Science Labs, 53796 Federal agency actions on proposed highways; judicial review claims: Election Assistance Commission Spanish Fork to Green River, UT (U.S. Route 6, I-15 to I- 70), 53810–53811 NOTICES Meetings; Sunshine Act, 53755 Federal Reserve System NOTICES Energy Department Banks and bank holding companies: See Southeastern Power Administration Formations, acquisitions, and mergers, 53772–53773

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Meetings; Sunshine Act, 53773 Housing and Urban Development Department RULES Federal Transit Administration Hearings and Appeals Office conforming amendments; and RULES Freedom of Information Act; implementation; Buy America requirements; end product analysis and correction, 53876–53879 waiver procedures, 53688–53698 NOTICES Agency information collection activities; proposals, submissions, and approvals, 53792–53794 Fish and Wildlife Service Mortgage and loan insurance programs: RULES Debenture interest rates, 53794–53795 Migratory bird hunting: Single family mortgage insurance— Seasons, limits, and shooting hours; establishment, etc., Risk-based premiums; announcement of planned 53882–53906 implementation, 53872–53873 PROPOSED RULES Endangered and threatened species: Findings on petitons, etc.— Interior Department Polar bear, 53749–53751 See Fish and Wildlife Service

Food and Drug Administration Internal Revenue Service PROPOSED RULES RULES Administrative rulings and decisions: Income taxes: Ozone depleting substances; essential use designations; Corporate estimated tax removal, 53711–53733 Correction, 53684 NOTICES PROPOSED RULES Agency information collection activities; proposals, Income taxes: submissions, and approvals, 53774–53778 Qualified films produced by taxpayers; domestic Meetings: production activities; attributable income deduction Current good manufacturing practices; educational Hearing cancellation, 53742 workshops, 53778–53779

Food Safety and Inspection Service Justice Department NOTICES See Drug Enforcement Administration Agency information collection activities; proposals, RULES submissions, and approvals, 53752–53753 Organization, functions, and authority delegations: Executive Office for Immigration Review, Director, et al., 53673–53678 Government Ethics Office NOTICES NOTICES Pollution control; consent judgments: Senior Executive Service Performance Review Board; Bayer Health Care LLC et al., 53795 membership, 53773–53774 Johnson, Randy, 53795–53796 Meridian Resource & Exploration LLC et al., 53796 Government Printing Office Reid, Richard, et al., 53795 NOTICES Meetings: Depository Library Council to the Public Printer, 53774 National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management: Health and Human Services Department Northeastern United States fisheries— See Children and Families Administration Northeast Region Standardized Bycatch Reporting See Food and Drug Administration Methodology Omnibus Amendment; See Health Resources and Services Administration implementation, 53751 See Substance Abuse and Mental Health Services Administration Nuclear Regulatory Commission Health Resources and Services Administration NOTICES NOTICES Environmental statements; availability, etc.: Agency information collection activities; proposals, Army Department, Adelphi Laboratory Center, MD, submissions, and approvals, 53779–53780 53801–53803 Reports and guidance documents; availability, etc.: Plants and materials; physical protection: Federal Tort Claims Act coverage for health center Radioactive materials of concern security; safeguards program grantees responding to emergencies; policy information protection and fingerprinting and guidance, 53780–53781 criminal history record check requirements, 53797– Health center emergency management program 53801 expectations; policy guidance, 53781 Patent and Trademark Office Homeland Security Department NOTICES See Transportation Security Administration Agency information collection activities; proposals, See U.S. Customs and Border Protection submissions, and approvals, 53753–53754

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Pipeline and Hazardous Materials Safety Administration Treasury Department PROPOSED RULES See Alcohol and Tobacco Tax and Trade Bureau Hazardous materials: See Internal Revenue Service Fuel cell cartridges and systems; transportation onboard passenger aircraft in carry-on baggage, 53744–53749 U.S. Customs and Border Protection NOTICES Small Business Administration Automation program test: NOTICES Automated Commercial Environment— Disaster loan areas: Truck carrier accounts; automated truck mainfest data; North Dakota, 53803 deployment schedule, 53789–53790 Tariff classification standards: Social Security Administration Unisex footware, 53790–53792 NOTICES Agency information collection activities; proposals, submissions, and approvals, 53803–53805 Separate Parts In This Issue

Southeastern Power Administration Part II NOTICES Environmental Protection Agency, 53814–53836 Power rates: Georgia-Alabama-South Carolina, 53755–53768 Part III Environmental Protection Agency, 53838–53870 Substance Abuse and Mental Health Services Administration Part IV Housing and Urban Development Department, 53872–53873 NOTICES Agency information collection activities; proposals, Part V submissions, and approvals, 53781–53784 Housing and Urban Development Department, 53876–53879

Transportation Department Part VI See Federal Aviation Administration Interior Department, Fish and Wildlife Service, 53882– See Federal Highway Administration 53906 See Federal Transit Administration See Pipeline and Hazardous Materials Safety Part VII Administration Justice Department, Drug Enforcement Administration, NOTICES 53908–53912 Aviation proceedings: Agreements filed; weekly receipts, 53805–53806 Certificates of public convenience and necessity and Reader Aids foreign air carrier permits; weekly applications, Consult the Reader Aids section at the end of this issue for 53806–53808 phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws. Transportation Security Administration To subscribe to the Federal Register Table of Contents NOTICES LISTSERV electronic mailing list, go to http:// Transportation Worker Identification Credential Program: listserv.access.gpo.gov and select Online mailing list Biometric reader specification and TWIC contactless archives, FEDREGTOC-L, Join or leave the list (or change smart card application, 53784–53789 settings); then follow the instructions.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

8 CFR 1003...... 53673 1240...... 53673 14 CFR 43...... 53678 97 (2 documents) ...... 53680, 53682 Proposed Rules: 39 (5 documents) ...... 53699, 53701, 53704, 53706, 53709 21 CFR Proposed Rules: 2...... 53711 1301...... 53734 23 CFR Proposed Rules: 950...... 53736 24 CFR 14...... 53876 15...... 53876 17...... 53876 20...... 53876 24...... 53876 25...... 53876 26...... 53876 180...... 53876 26 CFR 1 (2 documents) ...... 53684 Proposed Rules: 1...... 53742 27 CFR Proposed Rules: 4...... 53742 5...... 53742 7...... 53742 24...... 53742 32 CFR 199...... 53685 40 CFR 52...... 53686 Proposed Rules: 52...... 53743 63 (2 documents) ...... 53814, 53838 81...... 53743 47 CFR 73 (3 documents) ...... 53687, 53688 49 CFR 661...... 53688 Proposed Rules: 171...... 53744 173...... 53744 175...... 53744 50 CFR 20...... 53882 Proposed Rules: 17...... 53749 648...... 53751

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Rules and Regulations Federal Register Vol. 72, No. 182

Thursday, September 20, 2007

This section of the FEDERAL REGISTER Board of Immigration Appeals, and the General’s 2006 review of improving the contains regulatory documents having general Chief Immigration Judge. workings of the immigration hearing applicability and legal effect, most of which On November 25, 2002, the President process before the immigration judges are keyed to and codified in the Code of signed into law the Homeland Security and the Board. Federal Regulations, which is published under Act of 2002 (HSA) creating the new 50 titles pursuant to 44 U.S.C. 1510. Public Comments Department of Homeland Security The Code of Federal Regulations is sold by (DHS) and transferring the functions of The Department allowed a 60-day the Superintendent of Documents. Prices of the former Immigration and public comment period on the proposed new books are listed in the first FEDERAL Naturalization Service (INS) to the DHS. rule that ended on February 26, 2001. REGISTER issue of each week. Pub. L. 107–296, tit. IV, subtits. D, E, F, The Department received comments 116 Stat. 2135, 2192 (Nov. 25, 2002) from three members of the public on the (effective March 1, 2003). The Attorney proposed rule. DEPARTMENT OF JUSTICE General retains the functions of the A few of the comments discussed EOIR in the Department of Justice. HSA sections which pertained to the Board. 8 CFR Parts 1003 and 1240 § 1101, 6 U.S.C. 521; section 103(g) of As mentioned above, the Department [Docket No. EOIR 125F; AG Order No. 2907– the Immigration and Nationality Act has already published a regulation 2007] (INA, or the Act), 8 U.S.C. 1103(g). In relating to the organization of the Board RIN 1125–AA27 order to implement the transfer of and the powers delegated to the functions under the HSA, the Attorney Chairman of the Board, and comments Authorities Delegated to the Director of General reorganized title 8 of the Code relating to the Board were fully the Executive Office for Immigration of Federal Regulations and divided the discussed in that separate final rule, Review, and the Chief Immigration regulations into chapters, so that with one exception discussed here. Judge chapter I contains regulations relating to One commenter objected to the the functions of the former INS (now proposed redesignation of the members AGENCY: Executive Office for DHS) and chapter V contains of the Board to be known as appellate Immigration Review, Department of regulations relating to the functions of immigration judges, citing possible Justice. EOIR. 68 FR 9824 (Feb. 28, 2003); see confusion by the public. The ACTION: Final rule. also 68 FR 10349 (March 5, 2003). The Department has decided not to make regulations governing proceedings this change and withdraws that portion SUMMARY: This rule revises the Attorney before EOIR are now contained in 8 CFR of the proposed rule. The Act provides General’s regulations relating to the chapter V, beginning with part 1001. that immigration proceedings are delegation of authority to the Director of Portions of the proposed rule relating conducted by officials known as the Executive Office for Immigration to the organization of the Board of immigration judges, but the Act also Review (EOIR) and the Chief Immigration Appeals (Board) and the states clearly that these officials are Immigration Judge with respect to the powers delegated to the Chairman of the Department of Justice attorneys who are adjudicatory process. These rules are Board have already been incorporated designated by the Attorney General to intended to improve the management of into a separate final rule published by conduct such proceedings, and they are EOIR. the Department on August 26, 2002, subject to the Attorney General’s DATES: This rule is effective October 22, entitled Board of Immigration Appeals: direction and control. See section 2007. Procedural Reforms To Improve Case 101(b)(4) of the INA (8 U.S.C. FOR FURTHER INFORMATION CONTACT: Management, 67 FR 54878 (Aug. 26, 1101(b)(4)). However, there do appear to Kevin Chapman, Acting General 2002) (now codified at 8 CFR 1003.1). have been at least some instances of Counsel, Executive Office for The Department does not make any apparent confusion over time among Immigration Review, Office of the further changes in this rule to the some observers regarding the role and General Counsel, 5107 Leesburg Pike, powers of the Chairman or the status of the immigration judges. Suite 2600, Falls Church, VA 22041; organization of the Board. Similarly, the members of the Board are telephone (703) 305–0470. With respect to the remaining Department of Justice attorneys who SUPPLEMENTARY INFORMATION: provisions of the proposed rule relating serve as the Attorney General’s to the organization of EOIR and the delegates in deciding the cases that Background authority of the Director, the Chief come before them. See 8 CFR On December 26, 2000, the Immigration Judge, and the General 1003.1(a)(1), (d)(1). In their quasi- Department of Justice (Department) Counsel, this rule finalizes the judicial roles, the immigration judges published a proposed rule in the provisions as proposed in that rule as and the Board members exercise very Federal Register at 65 FR 81434, to final without substantial change, but important functions, making revise the Attorney General’s delegation makes necessary modifications to that adjudicatory decisions and exercising of management authority to officials of rule to include technical changes to discretion on behalf of the Attorney the Executive Office for Immigration reflect the enactment of the HSA, General. However, they are Executive Review (EOIR). Changes proposed by including the reorganization and Branch adjudicators and do not serve in that rule would add specific information renumbering of 8 CFR. In addition, as purely a judicial capacity. As the to 8 CFR on the organization of EOIR discussed further below, the Department Supreme Court has made clear, the and outline the respective authorities of is adding additional management immigration adjudication process (and EOIR’s Director, the Chairman of the directives flowing from the Attorney the Board’s role in that process) is an

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executive function that implicates not days, pursuant to section functions. These administrative only legal and factual issues, but also 208(d)(5)(A)(iii) of the INA. A credible components and programs are managed important immigration policy and fear review by an immigration judge has by assistant directors and other senior foreign relations interests, and the a statutory completion requirement of 7 level management officials. On ‘‘judiciary is not well positioned to days, under section 235(b)(1)(B)(iii)(III) occasion, as the Director shall decide, shoulder primary responsibility’’ for of the Act. In addition, the Board has an these officials may be in the best such determinations. INS v. Aguirre- established case management system position to respond to a particular Aguirre, 526 U.S. 415, 425 (1999).1 The where single Board members dispose of delegation of the Director’s authority. Department has decided not to change all assigned appeals within 90 days of The Department expects that the the title of the Board members, in order completion of the record on appeal, or Director, who is ultimately responsible to avoid possible confusion between the within 180 days after an appeal is for the supervision of EOIR, is best able key executive functions of the Board assigned to a three-member panel. 8 to delegate his authority and should not and the judicial role of the Federal CFR 1003.1(e)(8)(i). Moreover, be restricted to only a few agency courts. individual immigration judges set officials. The following is a discussion of the hearing calendars and prioritize cases. One commenter objected to the remaining comments relating to the Within each judge’s parameters for General Counsel’s now being ‘‘co-equal’’ organization of EOIR and the authority calendaring a case, that judge will take with the Deputy Director. The of the Director and Chief Immigration the time necessary for the case to be commenter expresses concern that the Judge, and the Department’s response. completed. Some cases take less time to General Counsel is on ‘‘an equal All three commenters raised concerns complete, some more, and most fall managerial basis with its second in with the provisions that allow the within the estimated times. command.’’ The Department directs the setting of priorities or time frames for Experience has shown that the time reader to § 1003.0(d) and (e). The the resolution of cases. They expressed frames do not ‘‘direct the result’’ of a language is clear that the Deputy concern that an official could direct the particular case, but rather that the Director ‘‘shall advise and assist . . . in outcome of a specific case by setting an guidelines promote timely results. The the management of EOIR,’’ while the unyielding completion goal which Department shares the commenters’ General Counsel, serving as chief legal would prevent an immigration judge concern for due process and fairness in counsel of EOIR, ‘‘shall provide legal from taking the time necessary to immigration proceedings. Timely advice and assistance to the Director adjudicate a case fairly. On this issue, adjudications ensure due process and [and] Deputy Director’’. The Department one commenter believes the rule can be fairness for the aliens in proceedings, as believes the language delineates the interpreted to abrogate the parties’ right well as for the government and its distinction in duties and responsibilities to a full and complete hearing. This citizens who have an interest in having appropriately. commenter would have the rule cases adjudicated, benefits conferred, Finally, one commenter proposed a recognize that only the immigration and the laws enforced. See generally change to the definition of immigration judge should determine the amount of Capital Area Immigrants’ Rights court in § 1003.9(d) arguing that the time necessary to complete a case. Coalition, v. U.S. Dep’t of Justice, 264 F. definition was inaccurate and that the One commenter asks whether the rule Supp. 2d 14 (D.D.C. 2003) (rejecting term ‘‘local sites’’ should be changed to is intended (a) To authorize an official challenges to the Attorney General’s ‘‘hearing location.’’ Currently, there are to establish time frames for particular reform of the Board’s procedures in 54 immigration courts nationwide that types or classes of cases which would be 2002); see also Nash, v. Bowen, 869 F.2d create or maintain records of guidelines for the judges to follow, but 675, 681 (2d Cir. 1989) (rejecting proceedings and serve as locations permit a departure from the guidelines administrative law judge (ALJ) where proceedings are held before in individual cases when necessary; or challenge to efforts by the Social immigration judges. There are also other hearing locations in detail cities or other (b) to have an official direct a judge to Security Administration (SSA) to hearing sites such as correctional cut short a particular case regardless of improve the quality, timeliness, and facilities where immigration hearings the judge’s need to take additional time. efficiency of the ALJ decision making are held before an immigration judge. The Department does not believe that process; ‘‘those concerns are more These other hearing locations are all the authority to establish time frames appropriately addressed by Congress or serviced by an administrative control and guidelines ‘‘directs’’ the result of by courts through the usual channels of immigration court and do not serve as the adjudication. Time frames and judicial review in Social Security cases. locations where documents and guidelines are designed to ensure the The bottom line in this case is that it correspondence pertaining to a record of timely adjudication and conclusion of was entirely within the Secretary’s proceeding can be filed. Therefore these proceedings, and their use is well- discretion to adopt reasonable facilities do not meet the definition of established in immigration procedure. administrative measures in order to improve the decision making process.’’) ‘‘immigration court’’ even though For example, asylum cases have a (citations omitted). hearings can be held at locations that statutory completion requirement of 180 Another commenter takes issue with are designated by the Office of the Chief § 1003.0(b)(2), which allows the Director Immigration Judge for administrative 1 As the Attorney General’s delegate, the Board issues precedential decisions which have been to delegate his authority to others. This and public convenience. As the accorded appropriate deference under the Supreme commenter is specifically concerned commenter correctly pointed out, state Court’s decisions in Chevron v. NRDC, 467 U.S. 837 with the Director’s ability to delegate his detention facilities, where hearings are (1984) (deference due agency interpretation of authority to ‘‘any other EOIR held before an immigration judge, statutes within delegated authority); INS v. Aguirre- Aguirre, 526 U.S. 415, 425 (1999) (Attorney General, employee,’’ arguing that such a would not meet the definition of and hence the Board, accorded Chevron deference); delegation is too broad. The Department ‘‘immigration court’’ since these and INS v. Cardoza-Fonseca, 480 U.S. 421, 448–49 disagrees with this comment and will facilities do not create or maintain (1987) (same), as administrative interpretations of maintain the regulation as proposed. records of proceedings. The Department the Act. Chevron deference is appropriate because the Board is interpreting the Act on behalf of the EOIR is comprised of three adjudicating will therefore maintain the definition of Attorney General. See also Gonzales v. Thomas, 126 components as well as certain immigration court as proposed in order S. Ct. 1613 (2006). administrative components and to avoid any confusion with other

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hearing locations where documents and Security with specific responsibility for #7—Mechanisms to detect poor conduct correspondence pertaining to records of identifying instances of fraud among the and quality proceedings are not accepted. applications for immigration benefits #11—Complaint procedures filed with USCIS, and U.S. Immigration The Attorney General’s Management In order to summarize and reflect and Customs Enforcement (ICE) has Review of the Immigration Hearing these new initiatives, for the Process ongoing enforcement efforts against information of participants in aliens who have submitted fraudulent immigration proceedings and the On January 9, 2006, the Attorney documents or who seek immigration general public, this final rule adds General directed a comprehensive benefits by fraud or misrepresentation. several brief new paragraphs to the review of the Immigration Courts and The United States Attorneys have also existing description of the duties of the the Board of Immigration Appeals. This successfully prosecuted, or obtained Director of EOIR in 8 CFR 1003.0(b)(1), review was undertaken in response to indictments against, numerous as follows: concerns about the quality of decisions individuals and rings that have engaged • Adding a new para (v) to ‘‘Provide for being issued by the immigration judges in widespread immigration fraud (in performance appraisals for and the Board and about reports of some cases involving hundreds of immigration judges and Board intemperate behavior by some instances of fraud in separate cases members while fully respecting their immigration judges. The Deputy perpetrated by the same conspirators). roles as adjudicators, including a Attorney General and the Associate Although the immigration judges and process for reporting adjudications Attorney General assembled a review the Board are authorized to respond to that reflect temperament problems or team, which over the course of several such fraud on a case-by-case basis,2 poor decisional quality’’ (with respect months conducted hundreds of there is also a need for a more to Attorney General directives #1 and interviews, administered an online systematic response to identified #7) survey, and analyzed thousands of instances of fraud, particularly where • Adding a new para (vi) to documents to assess the EOIR there are indications of wide-scale ‘‘Administer an examination for adjudicative process. organized efforts to engage in On August 9, 2006, the Attorney newly-appointed immigration judges immigration fraud. This final rule has General announced that the review was and Board members with respect to been revised to include a new provision complete, and he directed that a series their familiarity with key principles of for the General Counsel of EOIR to of measures be taken to improve immigration law before they begin to designate an anti-fraud officer to serve adjudications by the immigration judges adjudicate matters, and evaluate the as a point of contact and coordination and the Board. EOIR has already been temperament and skills of each new with respect to instances of fraud arising implementing most of those initiatives immigration judge or Board member through administrative and management in administrative proceedings before within 2 years of appointment’’ (with actions, although several of the EOIR. respect to Attorney General directives The final rule also includes new initiatives require changes to the #2 and #3) general provisions relating to training, • existing regulations and are being Adding a new para (vii) to ‘‘Provide support, and review of the quality of the implemented through separate for comprehensive, continuing adjudicatory process, reflecting several rulemaking actions. training and support for Board The following discussion reviews of the directives contained in the members, immigration judges, and some of the internal management Attorney General’s memorandum of EOIR staff in order to promote the initiatives arising from the Attorney August 9, 2006. Among the Attorney quality and consistency of General’s review. Although all of the General’s other specific directives in the adjudications’’ (with respect to following changes are being August 9 memorandum were: Attorney General directives #4, #5, #1—Performance appraisals for and #6) implemented through internal • management changes within EOIR, this immigration judges and Board Adding a new para (viii) to final rule has been revised to include a members ‘‘Implement a process for receiving, brief summary of these key initiatives as #2—Evaluation of newly-appointed evaluating, and responding to being among the Director’s specific immigration judges and Board complaints of inappropriate conduct responsibilities, as a permanent members within 2 years by EOIR adjudicators’’ (with respect reflection of these changes which will #3—Examination in immigration law for to Attorney General directive #11) newly-appointed immigration continue to be implemented over time. Regulatory Requirements Among the Attorney General’s key judges and Board members priorities was to improve the existing #4—Improved training for immigration Administrative Procedure Act judges and Board members processes for dealing with fraud and The provisions of this rule, in general, #5—Improved training and guidance for abuse in the immigration process. One finalize without substantive change a EOIR staff administrative step to further this goal #6—Improved on-bench reference proposed rule previously published for is the appointment of an anti-fraud materials and decision templates public notice and comment. officer in EOIR who will be in a position This final rule also incorporates to respond to concerns about instances 2 See, e.g., Ye v. U.S. Dep’t of Justice, 489 F.3d certain management directives relating of fraud arising in some of the hundreds 517 (2d Cir. 2007) (upholding adverse credibility to the appointment of an anti-fraud of thousands of cases being adjudicated finding where the immigration judge noted 23 officer, and new general provisions each year by the immigration judges and striking similarities in form and substance between relating to training, support, and review an alien’s asylum affidavit and another applicant’s the Board, providing for a single point affidavit submitted in a separate asylum case, of the quality of the adjudicatory of contact for coordination (both within advised the alien of his concern about the process, reflecting several of the EOIR and in communications with other similarities, arranged for DHS to provide her with directives contained in the Attorney interested agencies). U.S. Citizenship a redacted copy of the affidavit submitted in the General’s memorandum of August 9, other case, gave the alien several opportunities to and Immigration Services (USCIS), a address the similarities and provide any innocent 2006. All of these changes are a matter component of DHS, has established an explanation, and the alien failed to respond to the of agency organization, management, or Office of Fraud Detection and National immigration judge’s concerns). personnel and do not require prior

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notice and comment, and accordingly by this Executive Order. Accordingly, I 2. Revise § 1003.0 to read as follows: they are being included in this final rule this action has not been reviewed by the relating to EOIR. See 5 U.S.C. 553(a)(2) Office of Management and Budget. § 1003.0 Executive Office for Immigration Review. (exempting ‘‘a matter relating to agency Executive Order 13132 management or personnel’’); Id. (a) Organization. Within the § 553(b)(A) (exempting ‘‘rules of agency This rule will not have substantial Department of Justice, there shall be an organization, procedure, or practice’’). direct effects on the States, on the Executive Office for Immigration relationship between the national Review (EOIR), headed by a Director Regulatory Flexibility Act government and the States, or on the who is appointed by the Attorney The Attorney General, in accordance distribution of power and General. The Director shall be assisted with the Regulatory Flexibility Act (5 responsibilities among the various by a Deputy Director and by a General U.S.C. 605(b)), has reviewed this rule levels of government. Therefore, in Counsel. EOIR shall include the Board and, by approving it, certifies that it will accordance with section 6 of Executive of Immigration Appeals, the Office of affect only Department employees, Order 13132, the Department of Justice the Chief Immigration Judge, the Office individuals in immigration proceedings has determined that this rule does not of the Chief Administrative Hearing before the EOIR, and practitioners who have sufficient federalism implications Officer, and such other staff as the appear before EOIR. Therefore, this rule to warrant a federalism summary impact Attorney General or Director may will not have a significant economic statement. provide. impact on a substantial number of small (b) Powers of the Director.— (1) In Executive Order 12988 entities. general. The Director shall manage EOIR This rule meets the applicable and its employees and shall be Paperwork Reduction Act standards set forth in sections 3(a) and responsible for the direction and The provisions of the Paperwork 3(b)(2) of Executive Order 12988, Civil supervision of the Board, the Office of Reduction Act of 1995, Public Law 104– Justice Reform. the Chief Immigration Judge, and the Office of the Chief Administrative 13, 44 U.S.C. chapter 35, and its Congressional Review Act implementing regulations, 5 CFR part Hearing Officer in the execution of their 1320, do not apply to this final rule This action pertains to agency respective duties pursuant to the Act because there are no new or revised management, personnel and and the provisions of this chapter. record keeping or reporting organization and does not substantially Unless otherwise provided by the requirements. affect the rights or obligations of non- Attorney General, the Director shall agency parties and, accordingly, is not report to the Deputy Attorney General Unfunded Mandates Reform Act of 1995 a ‘‘rule’’ as that term is used by the and the Attorney General. The Director This rule will not result in the Congressional Review Act (Subtitle E of shall have the authority to: expenditure by state, local, and tribal the Small Business Regulatory (i) Issue operational instructions and governments, in the aggregate, or by the Enforcement Fairness Act of 1996 policy, including procedural private sector, of $100 million or more (SBREFA)). Therefore, the reporting instructions regarding the in any one year, and it will not requirement of 5 U.S.C. 801 does not implementation of new statutory or significantly or uniquely affect small apply. regulatory authorities; (ii) Direct the conduct of all EOIR governments. Therefore, no actions were List of Subjects deemed necessary under the provisions employees to ensure the efficient of the Unfunded Mandates Reform Act 8 CFR Part 1003 disposition of all pending cases, of 1995. Administrative practice and including the power, in his discretion, procedure, Aliens, Immigration, Legal to set priorities or time frames for the Small Business Regulatory Enforcement resolution of cases; to direct that the Fairness Act of 1996 Services, Organization and function (Government agencies). adjudication of certain cases be This rule is not a major rule as deferred; to regulate the assignment of defined by section 251 of the Small 8 CFR Part 1240 adjudicators to cases; and otherwise to Business Regulatory Enforcement Administrative practice and manage the docket of matters to be Fairness Act of 1996, 5 U.S.C. 804. This procedure and Aliens. decided by the Board, the immigration rule will not result in an annual effect I Accordingly, parts 1003 and 1240 of judges, the Chief Administrative on the economy of $100 million or chapter V of title 8 of the Code of Hearing Officer, or the administrative more; a major increase in costs or prices; Federal Regulations are amended as law judges; or significant adverse effects on follows: (iii) Provide for appropriate competition, employment, investment, administrative coordination with the productivity, innovation, or on the PART 1003—EXECUTIVE OFFICE FOR other components of the Department of ability of United States-based IMMIGRATION REVIEW Justice, with the Department of companies to compete with foreign- Homeland Security, and with the I based companies in domestic and 1. The authority citation for 8 CFR Department of State; export markets. part 1003 continues to read as follows: (iv) Evaluate the performance of the Authority: 5 U.S.C. 301; 6 U.S.C. 521; 8 Board of Immigration Appeals, the Executive Order 12866 U.S.C. 1101, 1103, 1154, 1155, 1158, 1182, Office of the Chief Immigration Judge, This rule has been drafted and 1226, 1229, 1229a, 1229b, 1229c, 1231, the Office of the Chief Administrative reviewed in accordance with Executive 1254a, 1255, 1324d, 1330, 1361, 1362; 28 Hearing Officer, and other EOIR Order 12866, section 1(b), Principles of U.S.C. 509, 510, 1746; sec. 2 Reorg. Plan No. activities, make appropriate reports and 2 of 1950; 3 CFR, 1949–1953 Comp., p. 1002; Regulation. This rule is limited to section 203 of Pub. L. 105–100, 111 Stat. inspections, and take corrective action agency organization, management and 2196–200; sections 1506 and 1510 of Pub. L. where needed; personnel as described by Executive 106–386, 114 Stat. 1527–29, 1531–32; section (v) Provide for performance appraisals Order 12866 § 3(d)(3) and, therefore, is 1505 of Pub. L. 106–554, 114 Stat. 2763A– for immigration judges and Board not a ‘‘regulation’’ or ‘‘rule’’ as defined 326 to –328. members while fully respecting their

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roles as adjudicators, including a including administering the disciplinary Director, the Chief Immigration Judge process for reporting adjudications that program for attorneys and accredited shall be responsible for the supervision, reflect temperament problems or poor representatives under subpart G of this direction, and scheduling of the decisional quality; part. immigration judges in the conduct of (vi) Administer an examination for (2) Fraud issues. The General Counsel the hearings and duties assigned to newly-appointed immigration judges shall designate an anti-fraud officer who them. The Chief Immigration Judge shall and Board members with respect to shall— have the authority to: their familiarity with key principles of (i) Serve as a point of contact relating (1) Issue operational instructions and immigration law before they begin to to concerns about possible fraud upon policy, including procedural adjudicate matters, and evaluate the EOIR, particularly with respect to instructions regarding the temperament and skills of each new matters relating to fraudulent implementation of new statutory or immigration judge or Board member applications or documents affecting regulatory authorities; within 2 years of appointment; multiple removal proceedings, (2) Provide for appropriate training of (vii) Provide for comprehensive, applications for relief from removal, the immigration judges and other OCIJ continuing training and support for appeals, or other proceedings before staff on the conduct of their powers and Board members, immigration judges, EOIR; duties; and EOIR staff in order to promote the (ii) Coordinate with investigative (3) Direct the conduct of all quality and consistency of authorities of the Department of employees assigned to OCIJ to ensure adjudications; Homeland Security, the Department of the efficient disposition of all pending (viii) Implement a process for Justice, and other appropriate agencies cases, including the power, in his receiving, evaluating, and responding to with respect to the identification of and discretion, to set priorities or time complaints of inappropriate conduct by response to such fraud; and frames for the resolution of cases, to EOIR adjudicators; and (iii) Notify the EOIR disciplinary direct that the adjudication of certain (ix) Exercise such other authorities as counsel and other appropriate cases be deferred, to regulate the the Attorney General may provide. authorities with respect to instances of assignment of immigration judges to (2) Delegations. The Director may fraud, misrepresentation, or abuse cases, and otherwise to manage the delegate the authority given to him by pertaining to an attorney or accredited docket of matters to be decided by the this part or by the Attorney General to representative. immigration judges; the Deputy Director, the General (f) Citizenship Requirement for (4) Evaluate the performance of the Counsel, the Chairman of the Board of Employment. (1) An application to work Immigration Courts and other OCIJ Immigration Appeals, the Chief at EOIR, either as an employee or a activities by making appropriate reports Immigration Judge, the Chief volunteer, must include a signed and inspections, and take corrective Administrative Hearing Officer, or any affirmation from the applicant that he or action where needed; other EOIR employee. she is a citizen of the United States of (5) Adjudicate cases as an (c) Limit on the Authority of the America. If requested, the applicant immigration judge; and Director. The Director shall have no must document United States (6) Exercise such other authorities as authority to adjudicate cases arising citizenship. the Director may provide. under the Act or regulations and shall (2) The Director of EOIR may, by (c) Limit on the Authority of the Chief not direct the result of an adjudication explicit written determination and to Immigration Judge. The Chief assigned to the Board, an immigration the extent permitted by law, authorize Immigration Judge shall have no judge, the Chief Administrative Hearing the appointment of an alien to an EOIR authority to direct the result of an Officer, or an Administrative Law Judge; position when necessary to accomplish adjudication assigned to another provided, however, that nothing in this the work of EOIR. immigration judge, provided, however, part shall be construed to limit the Subpart B—Office of the Chief that nothing in this part shall be authority of the Director under Immigration Judge construed to limit the authority of the paragraph (b) of this section. Chief Immigration Judge in paragraph (d) Deputy Director. The Deputy I 3. Revise the heading of Subpart B to (b) of this section. Director shall advise and assist the read as set forth above. (d) Immigration Court. The term Director in the management of EOIR and I 4. Revise § 1003.9 to read as follows: Immigration Court shall refer to the the formulation of policy and local sites of the OCIJ where guidelines. Unless otherwise limited by § 1003.9 Office of the Chief Immigration proceedings are held before immigration law or by order of the Director, the Judge. judges and where the records of those Deputy Director shall exercise the full (a) Organization. Within the proceedings are created and maintained. authority of the Director in the Executive Office for Immigration I 5. Revise § 1003.10 to read as follows: discharge of his or her duties. Review, there shall be an Office of the (e) General Counsel. Subject to the Chief Immigration Judge (OCIJ), § 1003.10 Immigration judges. supervision of the Director, the General consisting of the Chief Immigration (a) Appointment. The immigration Counsel shall serve as the chief legal Judge, the immigration judges, and such judges are attorneys whom the Attorney counsel of EOIR. The General Counsel other staff as the Director deems General appoints as administrative shall provide legal advice and assistance necessary. The Attorney General shall judges within the Office of the Chief to the Director, Deputy Director, and appoint the Chief Immigration Judge. Immigration Judge to conduct specified heads of the components within EOIR, The Director may designate immigration classes of proceedings, including and shall supervise all legal activities of judges to serve as Deputy and Assistant hearings under section 240 of the Act. EOIR not related to adjudications arising Chief Immigration Judges as may be Immigration judges shall act as the under the Act or this chapter. necessary to assist the Chief Attorney General’s delegates in the (1) Professional standards. The Immigration Judge in the management cases that come before them. General Counsel shall administer of the OCIJ. (b) Powers and duties. In conducting programs to protect the integrity of (b) Powers of the Chief Immigration hearings under section 240 of the Act immigration proceedings before EOIR, Judge. Subject to the supervision of the and such other proceedings the

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Attorney General may assign to them, DEPARTMENT OF TRANSPORTATION 34096). Among other changes, this rule immigration judges shall exercise the amended part 43, Appendix B, by powers and duties delegated to them by Federal Aviation Administration revising the introductory text of the Act and by the Attorney General paragraph (a) and adding a new through regulation. In deciding the 14 CFR Part 43 paragraph (d). This rule provided individual cases before them, and [Docket No. FAA–2007–28631; Amendment instructions so major alterations for fuel subject to the applicable governing No. 43–41] tanks and system modifications would standards, immigration judges shall be segregated from other major repairs RIN 2120–AJ11 exercise their independent judgment and alterations. and discretion and may take any action Recording of Major Repairs and Major The new paragraph (d) provided consistent with their authorities under Alterations instructions for disposition of the Form the Act and regulations that is 337, Major Repair and Alteration, appropriate and necessary for the AGENCY: Federal Aviation whenever extended-range fuel tanks are disposition of such cases. Immigration Administration (FAA), DOT. installed within the passenger judges shall administer oaths, receive ACTION: Final rule. compartment or a baggage compartment. evidence, and interrogate, examine, and As part of those instructions, paragraph SUMMARY: This action amends (c)(2) of Appendix B is referenced for cross-examine aliens and any witnesses. instructions to aviation maintenance Subject to §§ 1003.35 and 1287.4 of this distribution of Form 337. providers regarding submittal of FAA The FAA has found that since adding chapter, they may issue administrative Form 337, Major Repair and Alteration, subpoenas for the attendance of paragraph (d), there has been a decline for either major repair or major in Form 337s received for extended- witnesses and the presentation of alteration; or for extended-range fuel evidence. In all cases, immigration range fuel tanks. Review of part 43, tanks installed within the passenger Appendix B revealed a wrong address. judges shall seek to resolve the compartment or a baggage compartment. questions before them in a timely and As currently written, paragraph (c)(2) This change clarifies the mailing directs individuals to send a copy of impartial manner consistent with the instructions when submitting Form 337 Form 337 to an incorrect address. Any Act and regulations. to the FAA. The intent of this action is FAA Form 337 that describes a (c) Review. Decisions of immigration to amend the regulation to ensure modification to an aircraft fuel system judges are subject to review by the mailing requirements are clear and or that shows additional tanks installed, Board of Immigration Appeals in any accurate. should be mailed to the FAA, Aircraft case in which the Board has jurisdiction DATES: This amendment becomes Registration Branch, AFS–751, P.O. Box as provided in 8 CFR 1003.1. effective September 20, 2007. 25724, Oklahoma City, OK. All other (d) Governing standards. Immigration FOR FURTHER INFORMATION CONTACT: Kim FAA Form 337s should be mailed to the judges shall be governed by the Barnette, Aircraft Maintenance Division, FAA, Aircraft Registration Branch, provisions and limitations prescribed by Flight Standards Service, Federal AFS–750, P.O. Box 25504, Oklahoma the Act and this chapter, by the Aviation Administration, 800 City, OK. decisions of the Board, and by the Independence Avenue, SW., The change in this final rule will Attorney General (through review of a Washington, DC 20591; telephone: clarify and correct the mailing decision of the Board, by written order, (202–493–4922); facsimile: (202–267– instructions and does not affect any or by determination and ruling pursuant 5115); e-mail: [email protected]. other requirements in part 43. to section 103 of the Act). SUPPLEMENTARY INFORMATION: Reason for Final Rule PART 1240—PROCEEDINGS TO Authority for This Rulemaking This final rule amends the mailing DETERMINE REMOVABILITY OF The FAA’s authority to issue rules on instructions for FAA Form 337 in part ALIENS IN THE UNITED STATES aviation safety is found in Title 49 of the 43, Appendix B, paragraphs (c) and (d). United States Code. Subtitle I, Section The change will allow submission of I 6. The authority citation for 8 CFR 106 describes the authority of the FAA FAA Form 337 to the correct address. part 1240 continues to read as follows: Administrator. Subtitle VII, Aviation The intent of this action is to amend the Programs, describes in more detail the regulation to ensure that instructions for Authority: 8 U.S.C. 1103, 1182, 1186a, scope of the agency’s authority. submitting this form are clear and 1224, 1225, 1226, 1227, 1251, 1252 note, The FAA is issuing this rulemaking accurate. 1252a, 1252b, 1362; secs. 202 and 203, Pub. under the authority set forth in 49 Justification for Immediate Adoption L. 105–100 (111 Stat. 2160, 2193); sec. 902, U.S.C. 44701(a)(5). This regulation is Pub. L. 105–277 (112 Stat. 2681); 8 CFR part within the scope of that authority Because the circumstances described 2. because the Administrator is charged herein warrant immediate action, the Administrator finds that notice and Subpart A—Removal Proceedings with promoting safe flight of civil aircraft by, among other things, public comment under 5 U.S.C. 553(b) § 1240.1 [Amended] prescribing regulations and minimum is impracticable and contrary to the standards for practices, methods, and public interest. Further, the I 7. Amend § 1240.1 by removing the procedures the Administrator finds Administrator finds that good cause first and second sentences of paragraph necessary for safety in air commerce and exists under 5 U.S.C. 553(d) for making (a)(2). national security. this rule effective in less than 30 days Dated: September 12, 2007. after publication in the Federal Background Register. The amendment ensures Alberto R. Gonzales, On September 9, 1987, the FAA FAA’s commitment to the Anti Drug Attorney General. published a final rule entitled ‘‘Aircraft Abuse Act of 1988, Subtitle E, FAA [FR Doc. E7–18526 Filed 9–19–07; 8:45 am] Identification and Retention of Fuel Drug Enforcement Assistance Act of BILLING CODE 4410–30–P System Modification Records,’’ (52 FR 1988.

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Paperwork Reduction Act a proposed or final rule does not International Trade Impact Assessment Information collection requirements warrant a full evaluation, this order The Trade Agreements Act of 1979 associated with this final rule have been permits that a statement to that effect (Pub. L. 96–39) prohibits Federal previously approved by the Office of and the basis for it be included in the agencies from establishing any Management and Budget (OMB) under preamble if a full regulatory evaluation standards or engaging in related of the cost and benefits is not prepared. the provisions of the Paperwork activities that create unnecessary Such a determination has been made for Reduction Act of 1995 (44 U.S.C. obstacles to the foreign commerce of the this final rule. The reasoning for this section 3507(d)), and have been United States. Legitimate domestic determination follows: assigned OMB Control Number 2120– Since this final rule merely clarifies objectives, such as safety, are not 0020. FAA procedures, the expected outcome considered unnecessary obstacles. The An agency may not collect or sponsor will be a minimal impact with positive statute also requires consideration of the collection of information, nor may it net benefits, and a regulatory evaluation international standards and, where impose an information collection was not prepared. FAA has, therefore, appropriate, that they be the basis for requirement unless it displays a determined that this final rule is not a U.S. standards. The FAA has assessed currently valid OMB control number. ‘‘significant regulatory action’’ as the potential effect of this final rule and has determined that it will respond to International Compatibility defined in section 3(f) of Executive Order 12866, and is not ‘‘significant’’ as a domestic safety objective and not The FAA has determined that a defined in DOT’s Regulatory Policies considered an unnecessary obstacle to review of the Convention on and Procedures. trade. International Civil Aviation Standards and Recommended Practices is not Regulatory Flexibility Determination Unfunded Mandates Assessment warranted because there is not a The Regulatory Flexibility Act of 1980 Title II of the Unfunded Mandates comparable rule under ICAO standards. (Pub. L. 96–354) (RFA) establishes ‘‘as a Reform Act of 1995 (Pub. L. 104–4) requires each Federal agency to prepare Regulatory Evaluation, Regulatory principle of regulatory issuance that a written statement assessing the effects Flexibility Determination, International agencies shall endeavor, consistent with of any Federal mandate in a proposed or Trade Impact Assessment, and the objectives of the rule and of final agency rule that may result in an Unfunded Mandates Assessment applicable statutes, to fit regulatory and informational requirements to the scale expenditure of $100 million or more Changes to Federal regulations must of the businesses, organizations, and (adjusted annually for inflation with the undergo several economic analyses. governmental jurisdictions subject to base year 1995) in any one year by State, First, Executive Order 12866 directs that regulation. To achieve this principle, local, and tribal governments, in the each Federal agency shall propose or agencies are required to solicit and aggregate, or by the private sector; such adopt a regulation only upon a reasoned consider flexible regulatory proposals a mandate is deemed to be a ‘‘significant determination that the benefits of the and to explain the rationale for their regulatory action.’’ The FAA currently intended regulation justify its costs. actions to assure that such proposals are uses an inflation-adjusted value of Second, the Regulatory Flexibility Act given serious consideration.’’ The RFA $128.1 million in lieu of $100 million. of 1980 (Pub. L. 96–354) requires covers a wide-range of small entities, This final rule does not contain such agencies to analyze the economic including small businesses, not-for- a mandate. impact of regulatory changes on small profit organizations, and small Availability of Rulemaking Documents entities. Third, the Trade Agreements governmental jurisdictions. Act (Pub. L. 96–39) prohibits agencies Agencies must perform a review to You can get an electronic copy of from setting standards that create determine whether a rule will have a rulemaking documents using the unnecessary obstacles to the foreign significant economic impact on a Internet by— commerce of the United States. In substantial number of small entities. If 1. Searching the Department of developing U.S. standards, the Trade the agency determines that it will, the Transportation’s electronic Docket Act requires agencies to consider agency must prepare a regulatory Management System (DMS) Web page international standards and, where flexibility analysis as described in the (http://dms.dot.gov/search); appropriate, that they be the basis of RFA. 2. Visiting the FAA’s Regulations and U.S. standards. Fourth, the Unfunded However, if an agency determines that Policies Web page at http:// Mandates Reform Act of 1995 (Public a rule is not expected to have a www.faa.gov/regulations_policies/; or Law 104–4) requires agencies to prepare significant economic impact on a 3. Accessing the Government Printing a written assessment of the costs, substantial number of small entities, Office’s Web page at http:// benefits, and other effects of proposed section 605(b) of the RFA provides that www.gpoaccess.gov/fr/index.html. or final rules that include a Federal the head of the agency may so certify You can also get a copy by sending a mandate likely to result in the and a regulatory flexibility analysis is request to the Federal Aviation expenditure by State, local, or tribal not required. The certification must Administration, Office of Rulemaking, governments, in the aggregate, or by the include a statement providing the ARM–1, 800 Independence Avenue private sector, of $100 million or more factual basis for this determination, and SW., Washington, DC 20591, or by annually (adjusted for inflation with the reasoning should be clear. calling (202) 267–9680. Make sure to base year of 1995). This portion of the This final rule merely revises an identify the amendment number or preamble summarizes the FAA’s incorrect mailing address; the expected docket number of this rulemaking. analysis of the economic impacts of this outcome will have only a minimal Anyone is able to search the final rule. impact on any small entity affected by electronic form of all comments Department of Transportation Order this rulemaking action. Therefore, as the received into any of our dockets by the DOT 2100.5 prescribes policies and FAA Administrator, I certify that this name of the individual submitting the procedures for simplification, analysis, rule will not have a significant comment (or signing the comment, if and review of regulations. If the economic impact on a substantial submitted on behalf of an association, expected cost impact is so minimal that number of small entities. business, labor union, etc.). You may

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review DOT’s complete Privacy Act (1) Placed on board the aircraft as specified 4. The National Archives and Records statement in the Federal Register in § 91.417 of this chapter; Administration (NARA). For published on April 11, 2000 (Volume (2) Given to the aircraft owner; and information on the availability of this 65, Number 70; Pages 19477–78) or you (3) Forwarded to the Federal Aviation material at NARA, call 202–741–6030, may visit http://dms.dot.gov. Administration, Aircraft Registration Branch, AFS–751, Post Office Box 25724, Oklahoma or go to: http://www.archives.gov/ federal_register/ Small Business Regulatory Enforcement City, OK 73125, within 48 hours after the _ _ _ work is inspected. code of federal regulations/ Fairness Act _ * * * * * ibr locations.html. The Small Business Regulatory Availability—All SIAPs are available Enforcement Fairness Act (SBREFA) of Issued in Washington, DC on August 27, online free of charge. Visit nfdc.faa.gov 1996 requires FAA to comply with 2007. to register. Additionally, individual small entity requests for information or James J. Ballough, SIAP and Takeoff Minimums and ODP advice about compliance with statutes Director, Flight Standards Service. copies may be obtained from: and regulations within its jurisdiction. If [FR Doc. E7–18584 Filed 9–19–07; 8:45 am] 1. FAA Public Inquiry Center (APA– you are a small entity and you have a BILLING CODE 4910–13–P 200), FAA Headquarters Building, 800 question regarding this document, you Independence Avenue, SW., may contact your local FAA official, or Washington, DC 20591; or the person listed under the FOR FURTHER DEPARTMENT OF TRANSPORTATION 2. The FAA Regional Office of the INFORMATION CONTACT heading at the region in which the affected airport is beginning of the preamble. You can find Federal Aviation Administration located. out more about SBREFA on the Internet FOR FURTHER INFORMATION CONTACT: at http://www.faa.gov/ 14 CFR Part 97 Harry J. Hodges, Flight Procedure regulations_policies/rulemaking/ [Docket No. 30570; Amdt. No. 3236] Standards Branch (AFS–420), Flight sbre_act/. Technologies and Programs Division, List of Subjects in 14 CFR Part 43 Standard Instrument Approach Flight Standards Service, Federal Procedures; Miscellaneous Aviation Administration, Mike Aircraft, Aviation safety, Reporting Amendments and recordkeeping requirements. Monroney Aeronautical Center, 6500 AGENCY: Federal Aviation South MacArthur Blvd., Oklahoma City, The Amendment Administration (FAA), DOT. OK 73169 (Mail Address: P.O. Box I In consideration of the foregoing, the ACTION: Final rule. 25082, Oklahoma City, OK 73125) Federal Aviation Administration telephone: (405) 954–4164. amends part 43 of Title 14, Code of SUMMARY: This rule amends Standard SUPPLEMENTARY INFORMATION: This rule Federal Regulations as follows: Instrument Approach Procedures amends Title 14, Code of Federal (SIAPs) for operations at certain Regulations, Part 97 (14 CFR part 97) by PART 43—MAINTENANCE, airports. These regulatory actions are amending the referenced SIAPs. The PREVENTIVE MAINTENANCE, needed because of changes in the complete regulatory description of each REBUILDING, AND ALTERATIONS National Airspace System, such as the SIAP is listed on the appropriate FAA commissioning of new navigational I Form 8260, as modified by the National 1. The authority citation for part 43 facilities, adding of new obstacles, or continues to read as follows: Flight Data Center (FDC)/Permanent changing air traffic requirements. These Notice to Airmen (P–NOTAM), and is Authority: 49 U.S.C. 106(g), 40113, 44701, changes are designed to provide safe incorporated by reference in the 44703, 44705, 44707, 44711, 44713, 44717, and efficient use of the navigable amendment under 5 U.S.C. 552(a), 1 44725. airspace and to promote safe flight CFR part 51, and § 97.20 of Title 14 of I 2. Appendix B is amended by revising operations under instrument flight rules the Code of Federal Regulations. paragraphs (c) and (d) to read as follows: at the affected airports. The large number of SIAPs, their Appendix B to Part 43—Recording of DATES: This rule is effective September complex nature, and the need for a Major Repairs and Major Alterations 20, 2007. The compliance date for each special format make their verbatim SIAP is specified in the amendatory publication in the Federal Register * * * * * (c) Except as provided in paragraph (d) of provisions. expensive and impractical. Further, this appendix, for a major repair or major The incorporation by reference of airmen do not use the regulatory text of alteration made by a person authorized in certain publications listed in the the SIAPs, but refer to their graphic § 43.17, the person who performs the major regulations is approved by the Director depiction on charts printed by repair or major alteration and the person of the Federal Register as of September publishers of aeronautical materials. authorized by § 43.17 to approve that work 20, 2007. Thus, the advantages of incorporation shall execute an FAA Form 337 at least in ADDRESSES: Availability of matter by reference are realized and duplicate. A completed copy of that form shall be— incorporated by reference in the publication of the complete description (1) Given to the aircraft owner; and amendment is as follows: of each SIAP contained in FAA form (2) Forwarded to the Federal Aviation For Examination— documents is unnecessary. This Administration, Aircraft Registration Branch, 1. FAA Rules Docket, FAA amendment provides the affected CFR AFS–750, Post Office Box 25504, Oklahoma Headquarters Building, 800 sections and specifies the types of SIAP City, OK 73125, within 48 hours after the Independence Avenue, SW., and the corresponding effective dates. work is inspected. Washington, DC 20591; This amendment also identifies the (d) For extended-range fuel tanks installed 2. The FAA Regional Office of the airport and its location, the procedure within the passenger compartment or a baggage compartment, the person who region in which the affected airport is and the amendment number. located; performs the work and the person authorized The Rule to approve the work by § 43.7 shall execute 3. The National Flight Procedures an FAA Form 337 in at least triplicate. A Office, 6500 South MacArthur Blvd., This amendment to 14 CFR part 97 is completed copy of that form shall be— Oklahoma City, OK 73169 or, effective upon publication of each

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separate SIAP as amended in the 97, is amended by amending Standard Hagerstown, MD, Hagerstown Regional/ transmittal. For safety and timeliness of Instrument Approach Procedures, Richard A. Henson Fld, LOC RWY 9, Orig, change considerations, this amendment effective at 0901 UTC on the dates CANCELLED Portland, ME, Portland Intl Jetport, RADAR– incorporates only specific changes specified, as follows: 1, Orig, CANCELLED contained for each SIAP as modified by PART 97—STANDARD INSTRUMENT Charlotte, MI, Fitch H. Beach, RNAV (GPS) FDC/P–NOTAMs. RWY 20, Orig The SIAPs, as modified by FDC APPROACH PROCEDURES Bemidji, MN, Bemidji Regional, ILS OR LOC/ P–NOTAM, and contained in this I 1. The authority citation for part 97 DME RWY 25, Orig Columbus/W Pt/Starkville, MS, Golden amendment are based on the criteria continues to read as follows: contained in the U.S. Standard for Triangle Rgnl, ILS OR LOC RWY 18, Amdt Terminal Instrument Procedures Authority: 49 U.S.C. 106(g), 40103, 40106, 7 40113, 40114, 40120, 44502, 44514, 44701, Columbus/W Pt/Starkville, MS, Golden (TERPS). In developing these changes to 44719, 44721–44722. Triangle Rgnl, VOR/DME OR GPS–E, Amdt SIAPs, the TERPS criteria were applied 5A, CANCELLED only to specific conditions existing at I 2. Part 97 is amended to read as Columbus/W Pt/Starkville, MS, Golden the affected airports. All SIAP follows: Triangle Rgnl, VOR OR GPS–D, Amdt 5A, amendments in this rule have been CANCELLED § 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 Elizabeth City, NC, Elizabeth City CG Air previously issued by the FAA in a FDC [AMENDED] NOTAM as an emergency action of Station/Regional, ILS OR LOC RWY 10, Effective 25 OCT 2007 Amdt 1 immediate flight safety relating directly Manville, NJ, Central Jersey Regional, RNAV to published aeronautical charts. The Albertville, AL, Albertville Rgnl-Thomas J (GPS) RWY 7, Orig circumstances which created the need Brumlik Fld, RNAV (GPS) RWY 23, Amdt Manville, NJ, Central Jersey Regional, GPS for all these SIAP amendments requires 1 RWY 7, Orig-A, CANCELLED making them effective in less than 30 Deadhorse, AK, Deadhorse, ILS OR LOC/ Manville, NJ, Central Jersey Regional, RNAV days. DME RWY 5, Amdt 2 (GPS) RWY 25, Orig Deadhorse, AK, Deadhorse, RNAV (GPS) Manville, NJ, Central Jersey Regional, Takeoff Because of the close and immediate RWY 5, Amdt 1 relationship between these SIAPs and Minimums and Obstacle DP, Amdt 3 Deadhorse, AK, Deadhorse, RNAV (GPS) New York, NY, John F. Kennedy Intl, ILS OR safety in air commerce, I find that notice RWY 23, Amdt 1 LOC RWY 31R, Amdt 15 and public procedure before adopting Deadhorse, AK, Deadhorse, LOC/DM BC Okmulgee, OK, Okmulgee Regional, RNAV these SIAPs are impracticable and RWY 23, Amdt 11 (GPS) RWY 18, Amdt 1 contrary to the public interest and, Deadhorse, AK, Deadhorse, VOR/DME RWY Okmulgee, OK, Okmulgee Regional, Takeoff where applicable, that good cause exists 5, Amdt 2 Minimums and Obstacle DP, Amdt 1 for making these SIAPs effective in less Deadhorse, AK, Deadhorse, VOR/DME RWY Watonga, OK, Watonga Regional, RNAV 23, Amdt 4 than 30 days. (GPS) RWY 17, Orig Deadhorse, AK, Deadhorse, VOR RWY 5, Watonga, OK, Watonga Regional, VOR/DME– Conclusion Amdt 4 A, Amdt 3 Deadhorse, AK, Deadhorse, VOR RWY 23, Watonga, OK, Watonga Regional, GPS RWY The FAA has determined that this Amdt 6 17, Orig, CANCELLED regulation only involves an established Deadhorse, AK, Deadhorse, Takeoff Watonga, OK, Watonga Regional, Takeoff body of technical regulations for which Minimums and Obstacle DP, Amdt 1 Minimums and Textual DP, Amdt 1 frequent and routine amendments are Kenai, AK, Kenai Muni, RNAV (GPS) RWY New Castle, PA, New Castle Muni, RNAV necessary to keep them operationally 1L, Amdt 1 (GPS) RWY 5, Amdt 1 current. It, therefore—(1) Is not a Kenai, AK, Kenai Muni, RNAV (GPS) RWY New Castle, PA, New Castle Muni, RNAV 19R, Amdt 1 (GPS) RWY 23, Amdt 1 ‘‘significant regulatory action’’ under Kenai, AK, Kenai Muni, VOR/DME RWY 1L, Executive Order 12866; (2) is not a Pittsburgh, PA, Allegheny County, VOR–A, Amdt 7 Orig ‘‘significant rule’’ under DOT Kenai, AK, Kenai Muni, VOR RWY 19R, Pittsburgh, PA, Allegheny County, Takeoff Regulatory Policies and Procedures (44 Amdt 18 Minimums and Obstacle DP, Amdt 8 FR 11034; February 26, 1979); and (3) Kenai, AK, Kenai Muni, Takeoff Minimums Pittsburgh, PA, Allegheny County, RNAV does not warrant preparation of a and Obstacle DP, Amdt 1 (GPS) RWY 5, Amdt 2, CANCELLED regulatory evaluation as the anticipated Nome, AK, Nome, ILS OR LOC/DME Y RWY Pittsburgh, PA, Allegheny County, VOR RWY impact is so minimal. For the same 28, Amdt 3 5, Amdt 10, CANCELLED Nome, AK, Nome, ILS OR LOC/DME Z RWY North Kingstown, RI, Quonset State, ILS OR reason, the FAA certifies that this 28, Amdt 3 amendment will not have a significant LOC RWY 16, Amdt 9 Nome, AK, Nome, LOC/DME BC RWY 10, North Kingstown, RI, Quonset State, RNAV economic impact on a substantial Amdt 3 (GPS) RWY 16, Orig number of small entities under the St Johns, AZ, St Johns Industrial Air Park, North Kingstown, RI, Quonset State, RNAV criteria of the Regulatory Flexibility Act. VOR/DME–A, Amdt 2 (GPS) RWY 34, Orig St Johns, AZ, St Johns Industrial Air Park, North Kingstown, RI, Quonset State, GPS List of Subjects in 14 CFR Part 97 RNAV (GPS) RWY 14, Orig RWY 34, Amdt 1A, CANCELLED Air Traffic Control, Airports, Bishop, CA, Eastern Sierra Rgnl, LDA/DME Lexington-Parsons, TN, Beech River Rgnl, Incorporation by reference, and RWY 16, Orig Takeoff Minimums and Obstacle DP, Orig Navigation (Air). Middletown, DE, Summit, NDB–A, Amdt 7 Austin, TX, Lakeway Airpark, RNAV (GPS) Chicago/Aurora, IL, Aurora Muni, ILS OR RWY 16, Orig Issued in Washington, DC on September 7, LOC RWY 33, Orig Austin, TX, Lakeway Airpark, VOR/DME–A, 2007. Chicago/Aurora, IL, Aurora Muni, RNAV Amdt 1 James J. Ballough, (GPS) RWY 33, Amdt 1 Austin, TX, Lakeway Airpark, GPS RWY 16, Director, Flight Standards Service. Chicago/Aurora, IL, Aurora Muni, Takeoff Orig-B, CANCELLED Minimums and Obstacle DP, Amdt 1 Bonham, TX, Jones Field, RNAV (GPS) Rwy Adoption of the Amendment Fort Scott, KS, Fort Scott Muni, NDB RWY 35, Orig 18, Amdt 12 Dallas, TX, Addison, Takeoff Minimums and I Accordingly, pursuant to the authority Hagerstown, MD, Hagerstown Regional/ Obstacle DP, Amdt 5 delegated to me, Title 14, Code of Richard A. Henson Fld, ILS OR LOC RWY Dallas, TX, Dallas Love Field, Takeoff Federal regulations, Part 97, 14 CFR part 9, Orig Minimums and Obstacle DP, Amdt 15

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Dallas-Fort Worth, TX, Dallas-FT Worth Intl, effective 25 OCT 2007, the Standard 3. The National Flight Procedures CONVERGING ILS RWY 13R, Amdt 6A Instrument Approach Procedures listed Office, 6500 South MacArthur Blvd., Dallas-Fort Worth, TX, Dallas-FT Worth Intl, below are hereby corrected to be effective for Oklahoma City, OK 73169 or, ILS OR LOC RWY 13R, Amdt 7A December 20, 2007. 4. The National Archives and Records Dallas-Fort Worth, TX, Dallas-FT Worth Intl, Kobuk, AK, Kobuk, RNAV (GPS) RWY 9, RNAV (GPS) Y RWY 13R, Amdt 1A Orig Administration (NARA). For Dallas-Fort Worth, TX, Dallas-FT Worth Intl, Kobuk, AK, Kobuk, RNAV (GPS) RWY 27, information on the availability of this RNAV (GPS) Y RWY 31R, Amdt 1A Orig material at NARA, call 202–741–6030, Dallas-Fort Worth, TX, Dallas-FT Worth Intl, Kobuk, AK, Kobuk, Takeoff Minimums and or go to: http://www.archives.gov/ RNAV (RNP) Z RWY 13R, Orig-A Obstacle DP, Orig federal_register/code_of_ Dallas-Fort Worth, TX, Dallas-FT Worth Intl, _ _ [FR Doc. E7–18335 Filed 9–19–07; 8:45 am] federal regulations/ibr locations.html. RNAV (RNP) Z RWY 31L, Orig-A Availability—All SIAPs and Takeoff BILLING CODE 4910–13–P Fort Worth, TX, Fort Worth Spinks, Takeoff Minimums and ODPs are available Minimums and Obstacle DP, Amdt online free of charge. Visit nfdc.faa.gov Houston, TX, Pearland Rgnl, RNAV (GPS) Rwy 32, Amdt 2 DEPARTMENT OF TRANSPORTATION to register. Additionally, individual Houston, TX, Pearland Rgnl, VOR–B, Amdt SIAP and Takeoff Minimums and ODP 1 Federal Aviation Administration copies may be obtained from: Houston, TX, Pearland Rgnl, Takeoff 1. FAA Public Inquiry Center (APA– Minimums and Obstacle DP, Amdt 3 14 CFR Part 97 200), FAA Headquarters Building, 800 Lancaster, TX, Lancaster, Takeoff Minimums Independence Avenue, SW., [Docket No. 30569; Amdt. No. 3235] and Obstacle DP, Amdt 1 Washington, DC 20591; or Mc Kinney, TX, Collin County Regional at Standard Instrument Approach 2. The FAA Regional Office of the McKinney, Takeoff Minimums and Procedures, and Takeoff Minimums region in which the affected airport is Obstacle DP, Orig located. Nacogdoches, TX, A L Mangham Jr Regional, and Obstacle Departure Procedures; ILS OR LOC RWY 36, Amdt 3 Miscellaneous Amendments FOR FURTHER INFORMATION CONTACT: Logan, UT, Logan-Cache, ILS OR LOC/DME Harry. J. Hodges, Flight Procedure AGENCY: Federal Aviation RWY 17, Orig Standards Branch (AFS–420), Flight Administration (FAA), DOT. Lynchburg, VA, Lynchburg Rgnl/Preston Technologies and Programs Division, ACTION: Glenn Fld, ILS OR LOC RWY 4, Amdt 16 Final rule. Flight Standards Service, Federal Lynchburg, VA, Lynchburg Rgnl/Preston Aviation Administration, Mike Glenn Fld, RNAV (GPS) RWY 4, Orig SUMMARY: This Rule establishes, Lynchburg, VA, Lynchburg Rgnl/Preston amends, suspends, or revokes Standard Monroney Aeronautical Center, 6500 Glenn Fld, RNAV (GPS) RWY 22, Orig Instrument Approach Procedures South MacArthur Blvd., Oklahoma City, Lynchburg, VA, Lynchburg Rgnl/Preston (SIAPs) and associated Takeoff OK 73169 (Mail Address: P.O. Box Glenn Fld, VOR RWY 4, Amdt 12 Minimums and Obstacle Departure 25082 Oklahoma City, OK 73125) Lynchburg, VA, Lynchburg Rgnl/Preston Procedures for operations at certain telephone: (405) 954–4164. Glenn Fld, GPS RWY 22, Orig-B, airports. These regulatory actions are SUPPLEMENTARY INFORMATION: This rule CANCELLED needed because of the adoption of new amends Title 14 of the Code of Federal Lynchburg, VA, Lynchburg Rgnl/Preston or revised criteria, or because of changes Regulations, Part 97 (14 CFR part 97), by Glenn Fld, Takeoff Minimums and Obstacle DP, Amdt 7 occurring in the National Airspace establishing, amending, suspending, or Manassas, VA, Manassas Rgnl/Harry P. Davis System, such as the commissioning of revoking SIAPs, Takeoff Minimums Field, Takeoff Minimums and Obstacle DP, new navigational facilities, adding new and/or ODPs. The complete regulatory Amdt 3 obstacles, or changing air traffic description of each SIAP and its Melfa, VA, Accomack County, RNAV (GPS) requirements. These changes are associated Takeoff Minimums or ODP RWY 3, Amdt 1 designed to provide safe and efficient for an identified airport is listed on FAA Melfa, VA, Accomack County, RNAV (GPS) use of the navigable airspace and to form documents which are incorporated RWY 21, Orig promote safe flight operations under by reference in this amendment under 5 Melfa, VA, Accomack County, Takeoff instrument flight rules at the affected U.S.C. 552(a), 1 CFR part 51, and 14 Minimums and Obstacle DP, Amdt 1 airports. Tappahannock, VA, Tappahannock-Essex CFR part 97.20. The applicable FAA County, RNAV (GPS) RWY 10, Orig DATES: This rule is effective September Forms are FAA Forms 8260–3, 8260–4, Tappahannock, VA, Tappahannock-Essex 20, 2007. The compliance date for each 8260–5, 8260–15A, and 8260–15B when County, RNAV (GPS) RWY 28, Orig SIAP, associated Takeoff Minimums, required by an entry on 8260–15A. Tappahannock, VA, Tappahannock-Essex and ODP is specified in the amendatory The large number of SIAPs, Takeoff County, Takeoff Minimums and Obstacle provisions. Minimums and ODPs, in addition to DP, Orig The incorporation by reference of their complex nature and the need for Fond Du Lac, WI, Fond Du Lac County, LOC/ certain publications listed in the a special format make publication in the DME RWY 36, Orig Federal Register expensive and Fond Du Lac, WI, Fond Du Lac County, SDF regulations is approved by the Director RWY 36, Amdt 6B, CANCELLED of the Federal Register as of September impractical. Furthermore, airmen do not 20, 2007. use the regulatory text of the SIAPs, Effective 20 DEC 2007 ADDRESSES: Availability of matters Takeoff Minimums or ODPs, but instead Kobuk, AK, Kobuk, RNAV (GPS) RWY 9, incorporated by reference in the refer to their depiction on charts printed Orig amendment is as follows: by publishers of aeronautical materials. Kobuk, AK, Kobuk, RNAV (GPS) RWY 27, For Examination— Thus, the advantages of incorporation Orig 1. FAA Rules Docket, FAA by reference are realized and Kobuk, AK, Kobuk, Takeoff Minimums and publication of the complete description Obstacle DP, Orig Headquarters Building, 800 The FAA published the following Independence Avenue, SW., of each SIAP, Takeoff Minimums and Amendment in Docket No. 30567 Amdt No. Washington, DC 20591; ODP listed on FAA forms is 3233 to Part 97 of the Federal Aviation 2. The FAA Regional Office of the unnecessary. This amendment provides Regulations (Vol. 72, FR No. 172, page 51170, region in which the affected airport is the affected CFR sections and specifies dated, 06 SEP 2007) Under Section 97.15 located; the types of SIAPs and the effective

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dates of the SIAPs, the associated adopting these SIAPs, Takeoff Federal Regulations, Part 97 (14 CFR Takeoff Minimums, and ODPs. This Minimums and ODPs are impracticable part 97) is amended by establishing, amendment also identifies the airport and contrary to the public interest and, amending, suspending, or revoking and its location, the procedure, and the where applicable, that good cause exists Standard Instrument Approach amendment number. for making some SIAPs effective in less Procedures and/or Takeoff Minimums The Rule than 30 days. and/or Obstacle Departure Procedures effective at 0901 UTC on the dates This amendment to 14 CFR part 97 is Conclusion specified, as follows: effective upon publication of each The FAA has determined that this separate SIAP, Takeoff Minimums and regulation only involves an established PART 97—STANDARD INSTRUMENT ODP as contained in the transmittal. body of technical regulations for which APPROACH PROCEDURES Some SIAP and Takeoff Minimums and frequent and routine amendments are textual ODP amendments may have necessary to keep them operationally I 1. The authority citation for part 97 been issued previously by the FAA in a current. It, therefore—(1) Is not a continues to read as follows: Flight Data Center (FDC) Notice to ‘‘significant regulatory action’’ under Airmen (NOTAM) as an emergency Executive Order 12866; (2) is not a Authority: 49 U.S.C. 106(g), 40103, 40106, action of immediate flight safety relating ‘‘significant rule’’ under DOT 40113, 40114, 40120, 44502, 44514, 44701, directly to published aeronautical Regulatory Policies and Procedures (44 44719, 44721–44722. charts. The circumstances which FR 11034; February 26, 1979); and (3) I 2. Part 97 is amended to read as created the need for some SIAP and does not warrant preparation of a follows: Takeoff Minimums and ODP regulatory evaluation as the anticipated amendments may require making them impact is so minimal. For the same §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, effective in less than 30 days. For the reason, the FAA certifies that this 97.35, 97.37 [Amended] remaining SIAPs and Takeoff amendment will not have a significant Minimums and ODPs, an effective date economic impact on a substantial By amending: § 97.23 VOR, VOR/ at least 30 days after publication is number of small entities under the DME, VOR or TACAN, and VOR/DME provided. criteria of the Regulatory Flexibility Act. or TACAN; § 97.25 LOC, LOC/DME, Further, the SIAPs and Takeoff LDA, LDA/DME, LDA w/GS, SDF, SDF/ Minimums and ODPs contained in this List of Subjects in 14 CFR Part 97 DME; § 97.27 NDB, NDB/DME; § 97.29 amendment are based on the criteria Air Traffic Control, Airports, ILS, MLS, TLS, GLS, WAAS PA, MLS/ contained in the U.S. Standard for Incorporation by reference, and RNAV; § 97.31 RADAR SIAPs; § 97.33 Terminal Instrument Procedures Navigation (Air). RNAV SIAPs; § 97.35 COPTER SIAPs, (TERPS). In developing these SIAPs and § 97.37 Takeoff Minima and Obstacle Takeoff Minimums and ODPs, the Issued in Washington, DC on September 7, Departure Procedures. Identified as TERPS criteria were applied to the 2007. conditions existing or anticipated at the James J. Ballough, follows: affected airports. Because of the close Director, Flight Standards Service. * * * Effective Upon Publication and immediate relationship between Adoption of the Amendment these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find I Accordingly, pursuant to the authority that notice and public procedure before delegated to me, under Title 14, Code of

Date State City Airport FDC No. Subject

04/19/07 ...... MN St Paul ...... St Paul Downtown Holman Fld ...... 7/8689 ILS RWY 32, AMDT 4. 08/21/07 ...... NY Niagara Falls ...... Niagara Falls Intl ...... 7/4069 TKOF MINS AND OBSTACLE DP, AMDT 2. 08/21/07 ...... ME Sanford ...... Sanford Regional...... 7/4131 TKOF MINS AND OBSTACLE DP, AMDT 2. 08/29/07 ...... IA Le Mars ...... Le Mars Muni ...... 7/4988 TKOF MINS AND OBSTACLE DP, AMDT 1A. 08/29/07 ...... WI Waukesha ...... Waukesha County ...... 7/4989 TKOF MINS AND OBSTACLE DP, AMDT 5. 08/29/07 ...... OH Waverly ...... Pike County ...... 7/4990 TKOF MINS AND OBSTACLE DP, ORIG. 08/29/07 ...... WI Viroqua ...... Viroqua Muni ...... 7/4991 TKOF MINS AND OBSTACLE DP, ORIG. 08/29/07 ...... WI Milwaukee ...... General Mitchell International...... 7/4992 TKOF MINS AND OBSTACLE DP, AMDT 5. 08/29/07 ...... OK Woodward ...... West Woodward ...... 7/4993 TKOF MINS AND OBSTACLE DP, AMDT 1A. 08/29/07 ...... TX Bridgeport ...... Bridgeport Muni ...... 7/4994 TKOF MINS AND OBSTACLE DP, AMDT 1A. 08/29/07 ...... TX Midland ...... Midland Airpark...... 7/4995 TKOF MINS AND OBSTACLE DP, AMDT 2A. 08/29/07 ...... TX Corpus Christi ...... Corpus Christi Intl ...... 7/4996 TKOF MINS AND OBSTACLE DP, ORIG–A. 08/29/07 ...... TX Graham ...... Graham Muni...... 7/4999 TKOF MINS AND OBSTACLE DP, AMDT 2A.

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Date State City Airport FDC No. Subject

08/29/07 ...... OH Gallipolis ...... Gallia-Meigs Regional ...... 7/5000 TKOF MINS AND OBSTACLE DP. 08/29/07 ...... WI Richland Center...... Richland ...... 7/5001 TKOF MINS AND OBSTACLE DP, AMDT 1. 08/30/07 ...... GA Cordele ...... Crisp County-Cordele ...... 7/5255 NDB OR GPS RWY 10, AMDT 4B. 08/30/07 ...... GA Winder ...... Winder-Barrow ...... 7/5258 NDB OR GPS RWY 31, AMDT 8B. 08/30/07 ...... GA Winder ...... Winder-Barrow ...... 7/5259 LOC RWY 31, AMDT 8B. 08/30/07 ...... GA Winder-Barrow ...... Winder ...... 7/5261 VOR/DME OR GPS–A, AMDT 9B. 08/30/07 ...... MS Aberdeen/Amory ...... Monroe County ...... 7/5460 VOR OR GPS RWY 18, AMDT 6B. 09/04/07 ...... AZ Chandler ...... Stellar Airpark...... 7/5784 TKOF MINS AND OBSTACLE DP, AMDT 2.

[FR Doc. E7–18374 Filed 9–19–07; 8:45 am] Correction of Publication FOR FURTHER INFORMATION CONTACT: Timothy Sheppard at (202) 622–4910 BILLING CODE 4910–13–P Accordingly, the final regulations (TD (not a toll-free number). 9347), that was the subject of FR Doc. E7–14946, is corrected as follows: SUPPLEMENTARY INFORMATION: On page 44347, column 1, in the DEPARTMENT OF THE TREASURY Background preamble, under the paragraph heading The final regulations (TD 9347) that is Internal Revenue Service ‘‘Effect on other Documents’’, paragraph 5, line 7, the language, ‘‘rational the subject of this correction are under section 6655 of the Internal Revenue 26 CFR Part 1 underlying the conclusion in’’ is corrected to read ‘‘rationale underlying Code. the conclusion in’’. [TD 9347] Need for Correction LaNita Van Dyke, As published, these regulations (TD RIN 1545–AY22 Branch Chief, Publications and Regulations 9347) contains an error that may prove Branch, Legal Processing Division, Office of to be misleading and is in need of Corporate Estimated Tax; Correction Associate Chief Counsel (Procedure and clarification. Administration). AGENCY: Internal Revenue Service (IRS), [FR Doc. E7–18506 Filed 9–19–07; 8:45 am] List of Subjects in 26 CFR Part 1 Treasury. BILLING CODE 4830–01–P Income taxes, Reporting and ACTION: Correction to final regulations. recordkeeping requirements.

SUMMARY: This document contains a DEPARTMENT OF THE TREASURY Correction of Publication correction to final regulations that were Internal Revenue Service I Accordingly, 26 CFR part 1 is published in the Federal Register on corrected by making the following Tuesday, August 7, 2007 (72 FR 44338) correcting amendment: providing guidance to corporations with 26 CFR Part 1 respect to estimated tax requirements. PART 1—INCOME TAXES [TD 9347] DATES: This correction is effective I 1. The authority citation for part 1 September 20, 2007. RIN 1545–AY22 continues to read in part as follows: FOR FURTHER INFORMATION CONTACT: Authority: 26 U.S.C. 7805 * * * Timothy Sheppard at (202) 622–4910 Corporate Estimated Tax; Correcting (not a toll-free number). Amendment § 1.6655–2 [Corrected] SUPPLEMENTARY INFORMATION: AGENCY: Internal Revenue Service (IRS), I 2. Section § 1.6655–2(g)(2) Example. is Background Treasury. amended by removing the language ‘‘installment period in 2008, ABC’s is’’ ACTION: Correcting amendment. The final regulations (TD 9347) that is and adding the language ‘‘installment the subject of this correction are under period in 2008, ABC is’’ in its place. section 6655 of the Internal Revenue SUMMARY: This document contains a Code. correction to final regulations that were LaNita Van Dyke, published in the Federal Register on Need for Correction Branch Chief, Publications and Regulations Tuesday, August 7, 2007 (72 FR 44338) Branch, Legal Processing Division, Office of As published, these regulations (TD providing guidance to corporations with Associate Chief Counsel (Procedure and 9347) contains an error that may prove respect to estimated tax requirements. Administration). to be misleading and is in need of DATES: This correction is effective [FR Doc. E7–18504 Filed 9–19–07; 8:45 am] clarification. September 20, 2007. BILLING CODE 4830–01–P

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DEPARTMENT OF DEFENSE subsequently separates from active duty I For the reasons set out in the during the three-year survivor period. preamble, the Department of Defense Office of the Secretary amends 32 CFR part 199 as follows: II. Review of Public Comments 32 CFR Part 199 We provided a 60 day comment PART 199—[AMENDED] period on the interim final rule which [DoD–2006–OS–0209] was published in the Federal Register I 1. The authority citation for part 199 RIN 0720–AB02 on November 17, 2006 (71 FR 66871). continues to read as follows: We received no public comments. Authority: 5 U.S.C. 301; 10 U.S.C. chapter TRICARE; Changes Included in the III. Regulatory Procedures 55. National Defense Authorization Act for Fiscal Year 2006; TRICARE Dental Executive Order (EO) 12866 I 2. Section 199.13 is amended by Program Executive Order 12866 requires that a revising paragraphs (c)(3)(ii)(E)(2), to read as follows: AGENCY: Office of the Secretary, DoD. comprehensive regulatory impact analysis be performed on any ACTION: Final rule. § 199.13 TRICARE Dental Program. economically significant regulatory * * * * * SUMMARY: This final rule implements action, defined as one that would result section 713 of the National Defense in an annual effect of $100 million or (c) * * * Authorization Act for Fiscal Year 2006 more on the national economy or which (3) * * * would have other substantial impacts. (NDAA for FY06), Public Law 109–163. (ii) * * * The rule provides eligibility for survivor The Regulatory Flexibility Act (RFA) benefits under the TRICARE Dental requires that each Federal agency (E) * * * prepare, and make available for public Program (TDP) to include the active (2) Continuation of eligibility. Eligible comment, a regulatory flexibility duty spouse of a member who dies dependents of active duty members analysis when the agency issues a while on active duty for a period of while on active duty for a period of regulation which would have a more than 30 days who subsequently more than 30 days and eligible significant impact on a substantial separates from active duty during the dependents of members of the Ready number of small entities. This rule is three-year transitional survivor period. Reserve (i.e., Selected Reserve or not an economically significant DATES: Effective Date: September 20, regulatory action and will not have a Individual Ready Reserve, as specified 2007. significant impact on a substantial in 10 U.S.C. 10143 and 10144(b) respectively), shall be eligible for ADDRESSES: TRICARE Management number of small entities for purposes of continued enrollment in the TDP for up Activity, Skyline 5, Suite 810, 5111 the RFA, thus this final rule is not to three (3) years from the date of the Leesburg Pike, Falls Church, VA 22041. subject to any of these requirements. member’s death, if, on the date of the FOR FURTHER INFORMATION CONTACT: Col. This rule, although not economically significant under Executive Order death of the member, the dependent is Gary C. Martin, Office of the Assistant enrolled in the TDP, or is not enrolled Secretary of Defense (Health Affairs), 12866, is a significant rule under Executive Order 12866 and has been by reason of discontinuance of a former TRICARE Management Activity, enrollment under paragraphs telephone (703) 681–0039. reviewed by the Office of Management and Budget. The changes set forth in (c)(3)(ii)(E)(4)(ii) and (c)(3)(ii)(E)(4)(iii) SUPPLEMENTARY INFORMATION: this final rule involve an expansion of of this section, or is not enrolled because the dependent was under the I. Summary of Final Rule Provisions TRICARE benefits. minimum age for enrollment at the time Prior to section 713 of the FY 06 Paperwork Reduction Act of the member’s death, or is not NDAA, a surviving spouse who is a This rule will not impose additional qualified for enrollment because the member of the armed forces on active information collection requirements on dependent is a spouse who is a member duty for a period of more than 30 days the public under the Paperwork of the armed forces on active duty for at the time the other active duty military Reduction Act of 1995 (44 U.S.C. 3501– a period of more than 30 days but member spouse dies, and who 3511). subsequently separates or is discharged subsequently separates from active duty, We have examined the impact(s) of from active duty. This continued was ineligible for the TRICARE Dental the final rule under Executive Order enrollment is not contingent on the program (TDP) survivor benefit. The 13132 and it does not have policies that Selected Reserve or Individual Ready surviving active duty spouse was have federalism implications that would Reserve member’s own enrollment in ineligible because he or she was not have substantial direct effects on the the TDP. During the three-year period of enrolled in the program at the time of States, on the relationship between the continuous enrollment, the government the spouse’s death. Active duty national government and the States, or will pay both the government and the members are not eligible for enrollment on the distribution of power and beneficiary’s portion of the premium in the TDP. There are many dual responsibilities among the various share. military couples in the armed forces and levels of government, therefore, * * * * * the authority provided by section 713 of consultation with State and local Dated: September 13, 2007. the NDAA for FY06 directs the officials is not required. Department to expand the eligibility for L.M. Bynum, survivor benefits under the TDP to List of Subjects in 32 CFR Part 199 OSD Federal Register Liaison Officer, include the active duty spouse of a Dental program, Dental health, Health Department of Defense. member who dies while on active duty care, Health insurance, Military [FR Doc. 07–4654 Filed 9–19–07; 8:45 am] for a period of more than 30 days who personnel. BILLING CODE 5001–06–M

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ENVIRONMENTAL PROTECTION the rationale for EPA’s proposed action not subject to Executive Order 13045 AGENCY are explained in the NPR and will not ‘‘Protection of Children from be restated here. No public comments Environmental Health Risks and Safety 40 CFR Part 52 were received on the NPR. Risks’’ (62 FR 19885, April 23, 1997), because it approves a state rule [EPA–R03–OAR–2007–0450; FRL–8469–4] II. Final Action implementing a Federal standard. Approval and Promulgation of Air EPA is approving Regulation No. In reviewing SIP submissions, EPA’s Quality Implementation Plans; 1113—Open Burning as a revision to the role is to approve state choices, Delaware; Amendments to the Open Delaware SIP. This SIP revision was provided that they meet the criteria of Burning Regulation submitted on May 2, 2007. the Clean Air Act. In this context, in the absence of a prior existing requirement AGENCY: Environmental Protection III. Statutory and Executive Order Reviews for the State to use voluntary consensus Agency (EPA). standards (VCS), EPA has no authority ACTION: Final rule. A. General Requirements to disapprove a SIP submission for failure to use VCS. It would thus be SUMMARY: EPA is approving a State Under Executive Order 12866 (58 FR inconsistent with applicable law for Implementation Plan (SIP) revision 51735, October 4, 1993), this action is EPA, when it reviews a SIP submission, submitted by the State of Delaware. This not a ‘‘significant regulatory action’’ and to use VCS in place of a SIP submission SIP revision pertains to the amendments therefore is not subject to review by the that otherwise satisfies the provisions of of Delaware’s open burning regulation. Office of Management and Budget. For the Clean Air Act. Thus, the EPA is approving this SIP revision in this reason, this action is also not requirements of section 12(d) of the accordance with the Clean Air Act. subject to Executive Order 13211, ‘‘Actions Concerning Regulations That National Technology Transfer and DATES: Effective Date: This final rule is Significantly Affect Energy Supply, Advancement Act of 1995 (15 U.S.C. effective on October 22, 2007. Distribution, or Use’’ (66 FR 28355, May 272 note) do not apply. This rule does ADDRESSES: EPA has established a 22, 2001). This action merely approves not impose an information collection docket for this action under Docket ID state law as meeting Federal burden under the provisions of the Number EPA–R03–OAR–2007–0450. All requirements and imposes no additional Paperwork Reduction Act of 1995 (44 documents in the docket are listed in requirements beyond those imposed by U.S.C. 3501 et seq.). the www.regulations.gov Web site. state law. Accordingly, the Although listed in the electronic docket, B. Submission to Congress and the Administrator certifies that this rule Comptroller General some information is not publicly will not have a significant economic available, i.e., confidential business impact on a substantial number of small The Congressional Review Act, 5 information (CBI) or other information entities under the Regulatory Flexibility U.S.C. 801 et seq., as added by the Small whose disclosure is restricted by statute. Act (5 U.S.C. 601 et seq.). Because this Business Regulatory Enforcement Certain other material, such as rule approves pre-existing requirements Fairness Act of 1996, generally provides copyrighted material, is not placed on under state law and does not impose that before a rule may take effect, the the Internet and will be publicly any additional enforceable duty beyond agency promulgating the rule must available only in hard copy form. that required by state law, it does not submit a rule report, which includes a Publicly available docket materials are contain any unfunded mandate or copy of the rule, to each House of the available either electronically through significantly or uniquely affect small Congress and to the Comptroller General www.regulations.gov or in hard copy for governments, as described in the of the United States. EPA will submit a public inspection during normal Unfunded Mandates Reform Act of 1995 report containing this rule and other business hours at the Air Protection (Pub. L. 104–4). This rule also does not required information to the U.S. Senate, Division, U.S. Environmental Protection have tribal implications because it will the U.S. House of Representatives, and Agency, Region III, 1650 Arch Street, not have a substantial direct effect on the Comptroller General of the United Philadelphia, Pennsylvania 19103. one or more Indian tribes, on the States prior to publication of the rule in Copies of the State submittal are relationship between the Federal the Federal Register. This rule is not a available at the Delaware Department of Government and Indian tribes, or on the ‘‘major rule’’ as defined by 5 U.S.C. Natural Resources & Environmental distribution of power and 804(2). Control, 89 Kings Highway, P.O. Box responsibilities between the Federal C. Petitions for Judicial Review 1401, Dover, Delaware 19903. Government and Indian tribes, as FOR FURTHER INFORMATION CONTACT: Rose specified by Executive Order 13175 (65 Under section 307(b)(1) of the Clean Quinto, (215) 814–2182, or by e-mail at FR 67249, November 9, 2000). This Air Act, petitions for judicial review of [email protected]. action also does not have Federalism this action must be filed in the United SUPPLEMENTARY INFORMATION: implications because it does not have States Court of Appeals for the substantial direct effects on the States, appropriate circuit by November 19, I. Background on the relationship between the national 2007. Filing a petition for On June 21, 2007 (72 FR 34207), EPA government and the States, or on the reconsideration by the Administrator of published a notice of proposed distribution of power and this final rule does not affect the finality rulemaking (NPR) for the State of responsibilities among the various of this rule for the purposes of judicial Delaware. The NPR proposed approval levels of government, as specified in review nor does it extend the time of Delaware’s open burning regulation Executive Order 13132 (64 FR 43255, within which a petition for judicial (Regulation No. 1113). The formal SIP August 10, 1999). This action merely review may be filed, and shall not revision was submitted by the Delaware approves a state rule implementing a postpone the effectiveness of such rule Department of Natural Resources and Federal requirement, and does not alter or action. This action, pertaining to Environmental Control (DNREC) on May the relationship or the distribution of Delaware’s amendments to the open 2, 2007. Other specific requirements of power and responsibilities established burning regulation, may not be Delaware’s open burning regulation and in the Clean Air Act. This rule also is challenged later in proceedings to

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enforce its requirements. (See section Dated: September 6, 2007. Subpart I—Delaware 307(b)(2).) William T. Wisniewski, Acting Regional Administrator, Region III. I 2. In § 52.420, the table in paragraph List of Subjects in 40 CFR Part 52 I 40 CFR part 52 is amended as follows: (c) is amended by revising the title and Environmental protection, Nitrogen entries for Regulation No. 13—Open dioxide, Ozone, Reporting and PART 52—[AMENDED] Burning to read as follows: recordkeeping requirements, Volatile I 1. The authority citation for part 52 § 52.420 Identification of plan. organic compounds. continues to read as follows: * * * * * Authority: 42 U.S.C. 7401 et seq. (c) * * *

EPA-APPROVED REGULATIONS IN THE DELAWARE SIP

State effective EPA approval State citation Title/subject date date Additional explanation

*******

Regulation 1113 Open Burning (Formerly Regulation 13)

Section 1.0 ...... Purpose ...... 04/11/07 09/20/07 [Insert page number where the docu- ment begins]. Section 2.0 ...... Applicability ...... 04/11/07 09/20/07 [Insert page number where the docu- ment begins]. Section 3.0 ...... Definitions ...... 04/11/07 09/20/07 [Insert page number where the docu- ment begins]. Section 4.0...... Prohibitions and Related Provi- 04/11/07 09/20/07 [Insert page sions. number where the docu- ment begins]. Section 5.0 ...... Season and Time Restrictions .... 04/11/07 09/20/07 [Insert page number where the docu- ment begins]. Section 6.0 ...... Allowable Open Burning ...... 04/11/07 09/20/07 [Insert page number where the docu- ment begins]. Section 7.0 ...... Exemptions ...... 04/11/07 09/20/07 [Insert page number where the docu- ment begins].

*******

* * * * * 230B1, reallots Channel 230B1 from SUPPLEMENTARY INFORMATION: This is a [FR Doc. E7–18352 Filed 9–19–07; 8:45 am] Fishers to Lawrence, Indiana, as synopsis of the Commission’s Report BILLING CODE 6560–50–P Lawrence’s first local aural transmission and Order, MB Docket No. 05–67, service, and modifies Station WWFT adopted June 27, 2007, and released (FM)’s license accordingly. In order to June 29, 2007. The full text of this FEDERAL COMMUNICATIONS maintain local service at Fishers, the Commission decision is available for COMMISSION Report and Order reallots Channel inspection and copying during normal 238B, Station WFMS (FM), from business hours in the FCC’s Reference 47 CFR Part 73 Indianapolis to Fishers, Indiana, and Information Center at Portals II, 445 modifies Station WFMS (FM)’s license [DA 07–2882; MB Docket No. 05–67; RM– 12th Street, SW., Room CY–A257, 11116, RM–11342] accordingly. To accommodate the Washington, DC 20554. The document reallotment of Channel 230B1 to may also be purchased from the Lawrence, the Report and Order Radio Broadcasting Services; Clinton, Commission’s duplicating contractor, substitutes Channel 229A for Channel Fishers, Indianapolis, and Lawrence, Best Copy and Printing, Inc., Portals II, IN 230A at Station WPFR–FM. Clinton, Indiana, and modifies Station WPFR– 445 12th Street, SW., Room CY–B402, AGENCY: Federal Communications FM’s license accordingly. The Media Washington, DC 20554, telephone 1– Commission. Bureau’s Consolidated Database System 800–378–3160 or http:// ACTION: Final rule; dismissal. (CDBS) reflects these changes. www.BCPIWEB.com. The Commission will not send a copy of this Report and ADDRESSES: Federal Communications SUMMARY: This Report and Order Order in a report to be sent to Congress Commission; 445 Twelfth Street, SW., dismisses two Counterproposals as and the Government Accountability Washington, DC 20554. unacceptable for consideration. In Office pursuant to the Congressional addition, this Report and Order FOR FURTHER INFORMATION CONTACT: R. Review Act, see 5 U.S.C. 801(a)(1)(A), upgrades Channel 230A, Station WWFT Barthen Gorman, Media Bureau, (202) because Section 73.202(b) of the (FM), Fishers, Indiana, to Channel 418–2180.

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Commission’s Rules has not been FOR FURTHER INFORMATION CONTACT: unacceptable for consideration. In amended. Robert Hayne, Media Bureau (202) 418– addition, this Report and Order reallots 2177. Channel 279C0, Station KYVA–FM, Federal Communications Commission. SUPPLEMENTARY INFORMATION: This is a from Grants, New Mexico, to Church John A. Karousos, synopsis of the Report and Order in MB Rock, New Mexico, and modifies the Assistant Chief, Audio Division, Media Docket No. 05–245, adopted July 30, license of Station KYVA–FM Bureau. 2007, and released July 31, 2007. The accordingly. The foregoing change of [FR Doc. E7–18500 Filed 9–19–07; 8:45 am] full text of this decision is available for community provides the first local aural BILLING CODE 6712–01–P inspection and copying during normal transmission service to Church Rock. business hours in the FCC Reference The Media Bureau’s Consolidated Information Center at Portals II, CY– Database System (CDBS) reflects these FEDERAL COMMUNICATIONS A257, 445 12th Street, SW., changes. COMMISSION Washington, DC 20554. The complete ADDRESSES: Federal Communications text of this decision may also be 47 CFR Part 73 Commission, 445 Twelfth Street, SW., purchased from the Commission’s copy Washington, DC 20554. [DA 07–3478; MB Docket No. 05–245; RM– contractor, Best Copying and Printing, 111264, RM–11357] Inc. 445 12th Street, SW., Room CY– FOR FURTHER INFORMATION CONTACT: R. B402, Washington, DC 20554, telephone Barthen Gorman, Media Bureau, (202) Radio Broadcasting Services; Animas, 1–800–378–3160 or http:// 418–2180. NM; Corona de Tucson, AZ; www.BCPIWEB.com. The Commission SUPPLEMENTARY INFORMATION: This is a Lordsburg, NM; Sierra Vista, Tanque will send a copy of this Report and synopsis of the Commission’s Report Verde and Vail, AZ; and Virden, NM Order in a report to Congress and the and Order in MB Docket No. 05–263, adopted May 23, 2007, and released AGENCY: Federal Communications Government Accountability Office May 25, 2007. The full text of this Commission pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A). Commission decision is available for ACTION: Final rule. inspection and copying during normal List of Subjects in 47 CFR Part 73 SUMMARY: In response to the business hours in the FCC’s Reference Counterproposal filed by Cochise Radio, Radio broadcasting. Information Center at Portals II, 445 Broadcasting, LLC and Desert West Air I As stated in the preamble, the Federal 12th Street, SW., Room CY–A257, Ranchers Corporation, this document Communications Commission amends Washington, DC 20554. The document reallots Channel 267C3 from Corona de 47 CFR part 73 as follows: may also be purchased from the Tucson to Tanque Verde, Arizona, and Commission’s duplicating contractor, PART 73—RADIO BROADCAST modifies the license of Station KKYZ to Best Copy and Printing, Inc., Portals II, SERVICES specify Tanque Verde as the community 445 12th Street, SW., Room CY–B402, of license. To continue local service at I 1. The authority citation for part 73 Washington, DC 20554, telephone 1– Corona de Tucson, it reallots Channel continues to read as follows: 800–378–3160 or http:// www.BCPIWEB.com. The Commission 253A from Vail, Arizona, to Corona de Authority: 47 U.S.C. 154, 303, 334, 336. Tucson, and modifies the Station KRDX will not send a copy of this Report and license to specify Corona de Tucson as § 73.202(b) [Amended] Order in a report to be sent to Congress and the Government Accountability the community of license. To replace I 2. Section 73.202(b), the Table of FM Office pursuant to the Congressional local service at Vail, it substitutes Allotments under New Mexico, is Review Act, see 5 U.S.C. 801(a)(1)(A), Channel 279A for Channel 279C1 at amended by adding Animas, Channel because Section 73.202(b) of the Lordsburg, New Mexico, reallots 279C1 and by adding Virden, Channel Commission’s Rules has not been Channel 279A to Vail, and modifies the 228C1. outstanding construction permit (File amended. Federal Communications Commission. No. BNPH–20050609ABD) to specify Federal Communications Commission. operation on Channel 279A at Vail. John A. Karousos, John A. Karousos, Finally, it allots Channel 279C1 to Assistant Chief, Audio Division, Media Animas, New Mexico, and Channel Bureau. Assistant Chief, Audio Division, Media Bureau. 228C1 to Virden, New Mexico, as first [FR Doc. E7–18499 Filed 9–19–07; 8:45 am] [FR Doc. E7–18495 Filed 9–19–07; 8:45 am] local services. The reference coordinates BILLING CODE 6712–01–P for the Channel 267C3 allotment at BILLING CODE 6712–01–P Tanque Verde, Arizona, are 32–19–59 and 110–45–19. The reference FEDERAL COMMUNICATIONS coordinates for the Channel 253A COMMISSION DEPARTMENT OF TRANSPORTATION allotment at Corona de Tucson, Arizona, are 32–55–39 and 110–37–57. The 47 CFR Part 73 Federal Transit Administration reference coordinates for the Channel [DA 07–2196; MB Docket No. 05–263; RM– 279A allotment at Vail, Arizona, are 31– 11269] 49 CFR Part 661 58–16 and 110–35–59. The reference [Docket No. FTA–2005–23082] coordinates for the Channel 279C1 Radio Broadcasting Services; Church allotment at Animas, New Mexico, are Rock and Grants, NM RIN 2132–AA90 31–56–50 and 108–28–45. The reference AGENCY: Federal Communications Buy America Requirements; End coordinates for the Channel 228C1 Commission. Product Analysis and Waiver allotment at Virden, New Mexico, are ACTION: Final rule; dismissal. Procedures 32–24–12 and 108–53–59. With this action, this proceeding is terminated. SUMMARY: This Report and Order AGENCY: Federal Transit Administration DATES: Effective September 20, 2007. dismisses two Counterproposals as (FTA), DOT.

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ACTION: Final rule. clarifications to the Buy America Two commenters urged FTA to regulations. publish both the incoming request and SUMMARY: The Safe, Accountable, The Second Notice of Proposed the proposed determination in the Flexible, Efficient Transportation Equity Rulemaking (SNPRM) (71 FR 69412, Federal Register. Several commenters Act: A Legacy for Users (SAFETEA–LU) Nov. 30, 2006) addressed six issues complained that monitoring both FTA’s requires the Federal Transit identified in the original NPRM but not Web site and the Federal Register Web Administration (FTA or the Agency) to covered in the initial final rule: (1) A site on a daily basis for potential waiver make certain changes to the Buy publication process for public interest petitions was unduly burdensome. America requirements. This Final Rule waivers to provide an opportunity for One commenter to both the NPRM creates a new publication process for public comment; (2) a clarification of and SNPRM suggested that FTA not public interest waivers to provide an Buy America requirements with respect limit publication of decisions to opportunity for public comment; to microprocessor waivers; (3) new approvals of waiver petitions. The clarifies Buy America requirements with provisions to permit post-award commenter noted that lessons learned respect to microprocessor waivers; waivers; (4) clarifications in the from disapprovals lead to a better issues new provisions to permit post- definition of ‘‘end products’’ with understanding and application of the award waivers; clarifies the definition of regards to (a) components and Buy America requirements. ‘‘end products’’ with regards to subcomponents, (b) major systems, and components, subcomponents, and major (c) a representative list of end products; B. FTA Response systems, and provides a representative (5) a clarification of the requirements for FTA believes that a dual Federal list of end products; clarifies the final assembly of rolling stock and a list Register publication process for both requirements for final assembly of of representative examples of rolling incoming requests and proposed rolling stock and provides stock items; (6) expanding FTA’s list of determinations would be slow and representative examples of rolling stock eligible communications, train control, cumbersome, jeopardizing FTA’s ability components; expands FTA’s list of and traction power equipment; and to maintain a 30-day processing time. communications, train control, and added a technical correction; and, an FTA believes that publication of traction power equipment; and updates update of the debarment and suspension incoming requests on FTA’s Buy debarment and suspension provisions to provisions to bring them into America Web site with simultaneous bring them into conformity with conformity with statutory amendments notice to trade associations such as the statutory amendments made by made by SAFETEA–LU. American Public Transportation SAFETEA–LU. 1. Published Justification for Public Association (APTA) and the Community EFFECTIVE DATE: The effective date of Interest Waivers Transportation Association of America this publication is October 22, 2007. In the first NPRM, FTA proposed (CTAA) provides interested parties with FOR FURTHER INFORMATION CONTACT: amending 49 CFR 661.7(b) to implement adequate notice and opportunity to Richard Wong, Office of the Chief the SAFETEA–LU requirement that FTA comment, and that formal publication of Counsel, Federal Transit publish justifications for public interest FTA’s proposed determination and Administration, 1200 New Jersey waivers in the Federal Register and justification in the Federal Register Avenue, SE., Washington, DC 20590, provide for notice and comment. The meets SAFETEA–LU’s notice and (202) 366–4011 or NPRM proposed to continue the current comment requirements. As explained in [email protected]. practice of posting all public interest the NPRM and SNPRM, FTA believes SUPPLEMENTARY INFORMATION: waiver requests on FTA’s Buy America the plain language of SAFETEA–LU and its legislative history expressly requires I. Background Web site for public review and comment, with the additional step of FTA to issue a written justification and On November 28, 2005, the Federal publishing FTA’s proposed approvals in to publish it in the Federal Register, Transit Administration (FTA) published the Federal Register for additional and only in instances where the a Notice of Proposed Rulemaking comment. justification supports a waiver request. (NPRM) in the Federal Register (70 FR After a thorough review of the See 49 U.S.C. 5323(j)(3); see also H.R. 71246) that discussed several proposals comments received in response to the Conf. Rep. No. 109–203, at 952 (2005). mandated by SAFETEA–LU (Pub L. NPRM, which were discussed at length However, FTA agrees with the 109–59, August 10, 2005), and proposed in the SNPRM, FTA believed that commenter who asked FTA to also to provide further clarification of SAFETEA–LU intended a four-step publish denial letters, and FTA will existing FTA decisions on Buy America. process: (1) Publish the incoming public publish both approval and denial letters Due to the complexity of many Buy interest waiver request on FTA’s Web on its Web site, as FTA believes that America issues addressed in the NPRM site for public review and comment; (2) researchers and potential applicants and the divergence of opinion in publish FTA’s proposed approvals and will find both documents useful. important areas, FTA issued a final rule FTA’s justification in the Federal With regards to the concern that that addressed fewer subjects than Register for formal notice and comment; monitoring both FTA’s Web site and the addressed in the NPRM. (71 FR 14112, (3) issue a formal written decision to the Federal Register for public interest Mar. 21, 2006.) These more routine applicant; and (4) post copies of the waivers will be unduly burdensome, topics covered in the final rule formal decision on FTA’s Web site. FTA has made improvements to its Web included: (1) Administrative review; (2) site whereby interested parties can the definition of ‘‘negotiated A. Comments Received subscribe to be notified whenever a new procurement;’’ (3) the definition of FTA received six comments in item is published on a specific FTA ‘‘contractor;’’ (4) repeal of the general response to the SNPRM. All supported webpage, including FTA’s table of its waiver for Chrysler vans; (5) an expedited approach. Most supported Federal Register publications. FTA certification under negotiated the 30-day timeframe proposed in the believes that this proactive notification procurements; (6) pre-award and post- SNPRM, although one commented that system will reduce, if not eliminate, the award review of rolling stock purchases; providing fair public notice was more need to constantly monitor both FTA’s and (7) miscellaneous corrections and essential than a rapid turnaround. Web site and the Federal Register for

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waiver petitions and determination microcomputers and microprocessors, contract award where a bidder or offeror letters. without changing the current regulatory had originally certified compliance with Accordingly, FTA believes the regime. the Buy America requirements, but can following process meets the no longer comply with its certification B. FTA Response requirements specified in SAFETEA– and contractual obligations due to LU: (1) Post notification of the public In FTA’s attempt to clarify that the commercial impossibility or interest waiver request on FTA’s Web waiver applied to devices ‘‘used solely impracticability. site and solicit comments on the for the purpose of processing or storing In the SNPRM, FTA revised the request; (2) based on the comments data,’’ commenters misinterpreted this provisions in the first NPRM based on received, prepare a justification that effort to mean that ‘‘input/output’’ responses from commenters who explains the rationale for approving or facilities and software should now be recommended that in the interest of denying a waiver request; (3) publish excluded from the waiver’s coverage. consistency, FTA use the existing the justification in the Federal Register Such is not the case. Although the process for non-availability waivers set for notice and comment within a current version of the general waiver at forth in 49 CFR 661.7(c). In addition, reasonable time; and (4) publish the 49 CFR 661.7, Appendix A, does not commenters suggested that FTA include final decision on FTA’s Web site include the term ‘‘input/output’’ a ‘‘good faith’’ element in its regarding the waiver request, based on facility, FTA has interpreted the waiver deliberations. FTA agreed and the comments received in response to the to include software (‘‘microcomputer SNPRM proposed that a grantee, when published justification. equipment, including software, of making a request for a post-award It should be noted that upon review foreign origin can be procured by waiver, should provide specific of the formal comments received in grantees.’’) (Emphasis added.) In evidence of a contractor’s good faith response to the publication of the addition, the inclusion of input/output when justifying the post-award waiver. proposed determination and devices under the waiver provision was This evidence would include justification in the Federal Register, used in a previous definition of a information about the origin of the FTA may ultimately determine that a microcomputer. See 50 FR 18760, May product or materials, invoices, or other waiver is not in the public interest, and 2, 1985 (‘‘A basic microcomputer relevant solicitation documents as deny the request, despite FTA’s initial includes a microprocessor, storage, and requested and that the item to be determination. FTA believes that this input/output facility, which may or may procured cannot now be obtained methodology would create a total not be on one chip.’’) (Emphasis added.) domestically due to commercial processing time of about 30 calendar FTA agrees with commenters that impossibility or practicability. days. Congress did not intend for FTA to Additionally, when determining change its current regulatory treatment whether conditions exist to grant a post- 2. Microcomputer/Microprocessor of microcomputer equipment. See H.R. award waiver, the SNPRM stated that Waivers Conf. Rep. No. 109–203, at 952 (2005) FTA would consider all appropriate In the SNPRM, FTA requested (‘‘In directing the Secretary to issue new factors on a case-by-case basis. comment on its proposal to implement regulations regarding microprocessors, the SAFETEA–LU requirement to computers, or microcomputers, there is A. Comments Received ‘‘clarify’’ that any waiver of the Buy no intent to change the existing FTA received four comments on the America requirements for a regulatory treatment of software or of revised language. Two commenters, one microprocessor, computer, or microcomputer equipment.’’) Because a large public transit agency and one a microcomputer, applies ‘‘only to a SAFETEA–LU directed FTA to system manufacturer concurred with the device used solely for the purpose of ‘‘clarify,’’ not alter current regulatory SNPRM’s revised approach. The third processing or storing data’’ and does not policy, FTA will continue to allow both commenter, a large transit agency, extend to the product or device software and input/output devices to be expressed concerns about validating the containing a microprocessor, computer, covered under the microcomputer/ credibility of its supplier or contractor or microcomputer. microprocessor waiver, provided that and the sufficiency of the evidence that the waiver is limited to the device used needed to be submitted to FTA as part A. Comments Received solely for the processing or storing data. of the waiver request. The transit agency FTA received nine comments on this Consistent with prior FTA rulemakings was concerned that it could be placed issue, many of which echoed identical and letters of determination, the waiver in a conflict of interest position or comments submitted in response to the does not extend to an entire product or subjected to litigation if had to advocate initial NPRM, proposing the exclusion device merely because it contains a on behalf of a given vendor. The fourth of input/output devices and software. microprocessor or microcomputer, such commenter, a large trade association Other commenters voiced objections to as a laptop computer, video display representing transit agencies and their the current methodology of considering monitor, farecard reader, or similar vendors and suppliers, opined that the the cost of the microcomputer/ piece of hardware or equipment. consideration of other bidders or microprocessor as domestic content for offerors should have no consideration in purposes of meeting the 60% domestic 3. Post-Award Waivers FTA’s evaluation of post-award non- content requirement, suggesting that the FTA sought comment in the first availability requests, believing that a cost of the exempted item should be NPRM on its proposal to create a post- frustrated second-lowest bidder could excluded from the sum of the end award non-availability waiver. Under hold a transit agency ‘‘economic product’s domestic and non-domestic FTA’s current regulation, a bidder or hostage’’ to a frustrated competitor who content. On the other hand, several offeror that certifies compliance with had obtained limited remaining commenters stressed that existing Buy America is ‘‘bound by its original domestic supplies through exclusive regulatory practices must be continued certification’’ and ‘‘is not eligible for a distribution agreement or other to avoid significant disruption in the waiver of those requirements.’’ 49 CFR arrangement. According to the trade industry, emphasizing that FTA was 661.13(c). The NPRM’s proposed association, the situation would result directed to ‘‘clarify’’ its existing Buy language would allow grantees to in significant cost increases as the America interpretations with regard to request a non-availability waiver after transit agency would be forced to

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terminate its contract with the initial differential waiver if the price of whether manufactured or contractor with no effective competition acquiring a domestic product would unmanufactured, that is acquired for to ensure reasonable pricing. increase the cost of the overall contract public use under a federally funded to the transit agency by more than 25 third party contract.’’ To that point, FTA B. FTA Response percent. Because the SNPRM stated that created a list of representative end FTA believes that the language set FTA would consider ‘‘all appropriate products that was included in the forth in the SNPRM forms a reasonable factors on a case-by-case basis’’ in SNPRM. approach. With regard to proving deciding whether to grant a post-award Based on its analysis and review of supplier or contractor credibility, a waiver, FTA believes it would be the comments received in response to transit agency may reasonably rely upon appropriate to take the reasonableness the first NPRM, FTA concurred with the a contractor’s representation, as making of any cost differential into account majority of commenters who a knowingly false claim in a Federally- when deciding whether to grant a recommended that FTA adopt the funded procurement could subject a waiver request. Whether the 25 percent second ‘‘non-shift’’ proposal in the perjurious contractor to Federal cost differential would apply to the cost SNPRM, finding that such an approach criminal statutes and possible of the non-available domestic product or would (1) foster reasonable debarment from future contracting to the cost of the overall contract is a predictability and stability in the transit opportunities. With regard to the factor FTA would consider on a case-by- business community, (2) enable offerors sufficiency of the evidence, the SNPRM case basis, depending upon the and bidders to price proposals more stated that FTA will consider all factors significance of the product to the overall accurately, and (3) allow transit on a case-by-cases basis. If FTA believes contract. agencies to obtain better prices. that the document submitted by a Several commenters opposed the grantee or its contractor is insufficient, 4. ‘‘End Products’’ NPRM’s ‘‘non-shift’’ approach, stating inadequate, or suspect, FTA may SAFETEA–LU directed FTA to define that keeping track of aftermarket rolling request additional information to the term ‘‘end product,’’ and in defining stock parts would not only prove to be determine whether there is sufficient the term, FTA is to ‘‘address the an impossible burden for grantees, it evidence to justify granting a waiver. procurement of systems under the would also discourage parts suppliers With regard to the concerns of the definition to ensure that major system from developing an aftermarket support third commenter that submitting a procurements are not used to structure within the United States, waiver request would raise conflict-of- circumvent the Buy America potentially increasing the lead time for interest issues, FTA believes that requirements.’’ In addition, SAFETEA– the purchase of replacement parts. submitting a post-award waiver request LU directed FTA to develop a list of These concerns were based on the would not constitute advocacy on behalf representative end products that are assumption that FTA would treat of a given vendor, but rather, constitutes subject to Buy America requirements. replacement parts under the rolling advocacy on behalf of the transit agency stock standard (i.e., where sixty percent 4a. Defining ‘‘End Product’’ Under a itself, which would be forced into of the subcomponents of a component, Shift and Non-Shift Approach reopening a bid or otherwise encounter by cost, must be domestic, but forty performance delays without a post- FTA’s initial NPRM sought comments percent may be foreign-sourced). To award waiver. on two alternative definitions of the address the concerns of these FTA does not agree with the term ‘‘end product.’’ The first proposed commenters, the SNPRM proposed to comments from the fourth commenter definition came from FTA’s current, treat rolling stock replacement parts that the status of other bidders should long-standing practice whereby the end under the simpler ‘‘manufactured be excluded from consideration. The product is the deliverable item specified products’’ standard in 49 CFR 661.5, Buy America status of other responsive by the grantee in the third party which requires that a component be bidders, including losing bidders, is contract. Under this ‘‘shifting’’ manufactured domestically, without the materially relevant, particularly where methodology, the same item could be an need to document the origin of each of the winning bidder is seeking to end-product, a component, or a its subcomponents. As FTA’s Buy substitute non-domestic materials for subcomponent, depending upon the America regulation currently states, a domestic ones. The intent of Buy deliverable specified in the third party component of a manufactured product America is to safeguard American jobs contract, with applicable Buy America ‘‘is considered of U.S. origin if it is by requiring that steel, iron, and requirements attaching based on an manufactured in the United States, manufactured goods used in an FTA- item’s characterization. Applying this regardless of the origin of its funded project are produced in the shifting approach, FTA’s first proposed subcomponents.’’ 49 CFR 661.5(d)(2). United States—not to protect a definition stated: ‘‘End product means The SNPRM’s proposal to apply the particular contractor or supplier against any item subject to 49 U.S.C. 5323(j) ‘‘manufactured product’’ standard to the vagaries of the marketplace. In that is to be acquired by a grantee, as replacement parts is very different from deciding whether to grant a post-award specified in the overall project the current regulation that applies the waiver, therefore, FTA will consider the contract.’’ rolling stock standard to such parts. status of other bidders or offerors who FTA’s second proposal was to base Under the current regulation, a are Buy America compliant and can the definition of ‘‘end product’’ on that component of rolling stock, in order to furnish domestic material or products found in the Federal Acquisition be Buy America-compliant, must consist on an FTA-funded project. Concluding Regulation (FAR) at 48 CFR part 25 of at least 60% domestic otherwise would violate the legislative implementing the Buy American Act, 41 subcomponents. A rolling stock intent of Buy America. U.S.C. 10a–10d. Under this definition, component, if purchased later as a With regard to the commenter’s end products do not shift and replacement part, shifts upwards to concern that a losing bidder offering components and subcomponents retain become an ‘‘end product’’ and its American-made products could hold the their designation. FTA’s second subcomponents shift to become purchaser economic hostage and charge proposed definition for this ‘‘non-shift ‘‘components’’ and must consist of extortionary rates, FTA acknowledges approach’’ stated: ‘‘End product means 100% domestic, even if the original that it has the authority to grant a cost- any article, material, supply, or system, subcomponent was part of the vehicle’s

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allowable 40% non-domestic content. pricing,’’ adding that permanently fixing present regulation, a bicycle rack is The SNPRM proposed that replacement the status of a part as components or treated as a ‘‘component’’ if specified in components would retain their sub-components for all future purposes a contract for the purchase of a new bus, characterization as ‘‘components’’ would allow agencies to procure proven but is treated as an ‘‘end product’’ if throughout the life of the vehicle and replacement parts without non- subsequently purchased as an their replacements would not shift productive recordkeeping The transit aftermarket accessory or as part of a upwards to become ‘‘end products.’’ In agency expressed similar concerns that vehicle rehabilitation or retrofit. FTA addition, replacement components maintaining records of rolling stock end believes that the same Buy America would be subject to the ‘‘manufactured products, components, and end rules should apply regardless of when products’’ standard with regard to the products throughout the service life of the bicycle rack is purchased, i.e., a origin of its subcomponents. the vehicle would have been an bicycle rack will be treated as a By applying the ‘‘manufactured ‘‘unbearable burden.’’ The fare component and must comply with the products’’ standard to replacement collection system manufacturer manufactured products standard. This components, suppliers would still be concurred without additional comment, approach will lead to consistency in the required to manufacture replacement while the rolling stock manufacturer manufacturing of components and will components in the United States, stressed that components ‘‘should greatly simplify the procurement thereby preserving a domestic always be manufactured in the U.S. process for transit agencies and their manufacturing base while at the same regardless of whether the component suppliers. time recognizing the global marketplace was purchased as part of an end product In the NPRM, FTA considered an with regard to the procurement of or separately as a service part for an end approach that would have permitted the subcomponents. In addition, applying product.’’ replacement of non-domestic the ‘‘manufactured products’’ test to the B. FTA Response components and subcomponents with acquisition of replacement components identical products of non-domestic Based on the comments received, FTA relieves manufacturers and buyers of the manufacture. But due to comments from is adopting the SNPRM’s non-shift burden of documenting country-of- transit agencies that maintaining approach. Under the current regulation, origin records for an endless number of country-of-origins records for every a procurement for a replacement part, possible subcomponents, so long as the component and subcomponent whether the part was previously component itself is manufactured in the throughout a vehicle’s useful service life classified as a component or a sub- United States. FTA believed the was too great of a recordkeeping burden, component, is treated as a procurement SNPRM’s approach provided limited FTA is not adopting this approach. relief from current practices and was not for an ‘‘end product.’’ Under the new FTA believes that the benefits of the likely to disrupt the supply industry. approach, procurements for replacement A more significant change in the parts, whether components or non-shift approach to the procurement SNPRM pertained to the replacement of subcomponents of the original end of replacement parts outweigh any subcomponents. Under the current product, would retain their potential impact on replacement parts regulation, if a purchaser replaces characterization and the requirements manufacturers. FTA finds it noteworthy rolling stock subcomponents, those applicable to manufactured products that despite publication of the SNPRM replacement parts also shift upwards to would apply. This new approach would and a request for data in the February become ‘‘end products’’ (i.e., the item apply consistently to the procurement of public meeting, FTA received no must be American-made). The SNPRM replacement parts for rolling stock as comments to the docket from domestic proposed that replacement parts would well as to manufactured products. suppliers of replacement be subject to the same Buy America This approach to replacement parts is subcomponents that quantified any requirements that applied to the original supported by the trade association’s adverse economic effects, particularly part—subcomponents would not shift comments that the SNPRM’s approach since the SNPRM would have subjected upwards to become ‘‘end products’’ but would ‘‘provide the market them to potential foreign competition. would instead remain ‘‘subcomponents’’ predictability the transit industry needs FTA believes that adopting the non- throughout the life of the vehicle. Albeit to maintain stability and reasonable shift approach will benefit transit such a rule might lead to an increase in pricing,’’ and that ‘‘fixing their status as agencies in their direct procurement of the level of foreign-sourced replacement components or sub-components for all replacement parts, and lead to parts, FTA believed that the benefits of future purposes will allow agencies to additional cost-savings to transit consistency, stability, and favorable procure replacement parts without non- agencies and component manufacturers price structures in the transit industry productive record keeping.’’ For rolling in the procurement of subcomponents. and would outweigh any disadvantages stock components, FTA recognizes that The non-shift approach will also to domestic suppliers. the illustrative list of ‘‘typical’’ rolling provide consistency and stability with stock components in Appendices B and regard to the identity of components A. Comments Received C to 49 CFR 661.11 will assist and subcomponents, eliminating the The four parties who submitted procurement officers in identifying distinctions between the procurement of comments on this issue represented a components. For manufactured rolling stock and manufactured product broad cross-section of docket products, the contract or the bid replacement parts, and different commenters—one of the nation’s largest proposal would govern the hierarchy of procurement standards for replacement public transit agencies, a manufacturer components and subcomponents. parts and aftermarket products. Transit of an integrated fare collection system, In addition, the classification of agencies will be able to procure a manufacturer of rolling stock, and a ‘‘components’’ and ‘‘subcomponents’’ replacement parts from the original part large industry trade association. All four would not only apply to the manufacturers, purchasing agents will endorsed FTA’s proposal. procurement of items purchased as part find it easier to determine the applicable The SNPRM, the trade association of the vehicle’s original equipment, but Buy America rules when attempting to noted, ‘‘will provide the market would apply consistently to the same procure replacement parts, and opening predictability the transit industry needs item if purchased as an aftermarket the market to foreign and domestic to maintain stability and reasonable accessory. To illustrate, under the sources will guarantee favorable price

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structures in the transit industry and A. Comments Received procured by a grantee as specified in the cost savings to the American taxpayer. Five commenters responded to FTA’s overall project contract. Furthermore, FTA believes that the fare collection 4b. ‘‘System’’ as an ‘‘End Product’’ proposal. Four were generally appreciative of FTA’s approach, while system at issue in its 2002 SAFETEA–LU requires that ‘‘the determination would have met the procurement of systems’’ be addressed one, a transit vehicle manufacturer, found the concept ‘‘confusing and SNPRM’s definition of ‘‘system:’’ the ‘‘to ensure that major system warranty clause referred to a single end procurements are not used to unnecessary,’’ and urged a more concise definition and a full listing of end product, i.e., an automated fare circumvent the Buy America collection system; the automated fare requirements.’’ The NPRM sought products. A large transit agency supported FTA’s definition, proposing collection system was the subject of a comment on whether FTA should single procurement whereby the continue its longstanding practice of that FTA add a ‘‘minimum set of components and interconnections’’ manufactured ‘‘end product’’ was including ‘‘systems’’ as definable end functionally different than that which products. Furthermore, FTA sought factor to the criteria. A large industry trade association, while appreciative of would have resulted from a mere comment on a proposed definition of assembly of elements or materials; and ‘‘system’’ which was based on the FTA’s efforts, commented that the most importantly, the individual parts ‘‘functional test’’ for interconnected SNPRM ‘‘fails to provide necessary performed on an integrated basis with systems from the Harmonized Tariff guidance to the industry’’ and stated other parts of the system. Schedule of the United States (HTSUS), that the list of characteristics should be 19 U.S.C. 1202, heading 8474, used in expanded, lest the absence of one Under FTA’s Buy America current customs law. The NPRM proposed to characteristic be seen as determinative. methodology, if a purported end define ‘‘system’’ as ‘‘a machine, product, The commenter added that the product is too large, i.e., composed of or device, or a combination of such definition should address what types of what FTA traditionally considers as equipment, consisting of individual systems would not be eligible for separate ‘‘end products’’ such as components, whether separate or consideration as end products. A structures, vehicles, fare collection interconnected by piping, transmission manufacturer of a fare collection system equipment, etc., FTA will break it down devices, electrical cables or circuitry, or responded to the trade association’s into separate end products. FTA’s by other devices, which are intended to comments, stating that the trade willingness to do this in previous contribute together to a clearly defined association’s members were unable to requests to evaluate the characterization function.’’ achieve consensus on this issue and that of a turnkey rail project as a ‘‘system’’ Although many commenters because the trade association was should allay the fears of commenters expressed concerns that manufacturers unable to propose clear product-specific that an end product system could be so could potentially abuse the definition of categories as an alternative definition to large, and incorporate so many different ‘‘system’’ to incorporate a large degree FTA’s approach, FTA should instead levels of equipment such as stations, of non-domestic subcomponents into a use principles in performing its track, vehicles, fare collection single ‘‘end product’’ procurement, a analysis. equipment, etc., that Buy America majority of commenters encouraged B. FTA Response requirements could be circumvented. FTA to continue its longstanding FTA remains aware that a single large- practice of including a ‘‘system’’ as a Based on the comments received and scale procurement could conceivably definable end product. Furthermore, on SAFETEA–LU’s statutory language contain multiple end products, each of FTA noted that SAFETEA–LU only and legislative history, FTA is retaining which must independently meet the required FTA to develop a rule to the SNPRM’s definition of a ‘‘system’’ ‘‘ensure that major system procurements and will add the term ‘‘system’’ to the requirements of Buy America. But at the are not used to circumvent the Buy definition of ‘‘end product.’’ FTA same time FTA also recognizes that America requirements,’’ and did not believes the definition proposed in the various elements may be integrated into expressly seek to prohibit the SNPRM and the new illustrative criteria a single system. FTA is aware of the designation of systems as end products. will protect against the bundling of developing trend towards systems Rather, SAFETEA–LU instructed FTA to unrelated independent products into a procurements and the potential develop a rule that would cure potential ‘‘super system’’ that would undermine circumvention of Buy America abuses, without eliminating system the principles of Buy America. Most requirements, and will therefore procurements or drastically changing importantly, as FTA explained in the exercise heightened scrutiny in this FTA’s long-standing Buy America SNPRM, FTA is willing to carefully area, using the new criteria. FTA notes, practices. review major system procurements to however, that the criteria are illustrative FTA received many comments determine whether an integrated system rather than determinative, and that offering alternatives to the NPRM’s actually exists, and, if so, which items lacking one of the criteria would not proposed definition of ‘‘system.’’ Some constitute the system. This review necessarily result in the automatic commenters suggested FTA should process will further serve to avoid the disqualification of a ‘‘system.’’ consider whether performance circumvention of Buy America 4c. Representative List of End Products warranties apply to an integrated requirements. system; whether products perform on an FTA believes a fare collection system, SAFETEA–LU directed FTA to integrated basis with other products in in toto, meets the definition of an ‘‘end develop a ‘‘representative list’’ of end a system, or are operated independently product.’’ FTA reached this conclusion products. FTA sought comment on a of associated products in the system; or in a 1994 and 2002 decision involving proposed list of representative end whether transit agencies routinely the Massachusetts Bay Transportation products in the first NPRM, and as FTA procure a product separately (other than Authority (MBTA), and a 1995 decision explained then, the proposed list was as replacement or spare parts). Based on involving the Tri-County Metropolitan not meant to be all-inclusive, instead these comments, FTA rewrote the District of Oregon. In these three describing general ‘‘representative’’ SNPRM’s definition of ‘‘system’’ to decisions FTA cited 49 CFR § 661.11(s) categories of end products consistent incorporate these criteria. in defining ‘‘end product’’ as any item with the legislation.

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A. Comments Received that is not meant to be all-inclusive and submitted lengthy comments to the FTA received five comments on this to rely upon basic governing principles SNPRM describing their opposition. issue. Of these, two commenters to address future deliberations. An These commenters pointed out that the concurred with FTA’s approach. One example of this practical approach are Dear Colleague letter has been commenter stated that FTA’s proposed the representative lists of typical bus successfully implemented for the past representative list was ‘‘too abbreviated and rail car components found in ten years, and that any changes could and inconsistent,’’ recommending that Appendices B and C to 49 CFR 661.11. create confusion for manufacturers and FTA issue a more extensive or Manufactured products not enumerated grantees. One commenter noted that the on those component lists can be Dear Colleague letter reflected extensive comprehensive list and subjecting that analyzed within the context of other input from industry participants. list for public comment before items on those lists, using governing Vehicle manufacturers stated that they publishing it as a Final Rule. Another principles. FTA’s representative list of had made long-term operational and commenter representing a coalition of ‘‘end products’’ is similarly reflective of investment decisions based on existing manufacturers provided a list of end the broad scope of transit procurements law and guidance, and changing policy products that it believed should be and new end products can be similarly would be ‘‘extremely onerous and added to the representative list, stating assessed. harmful to manufacturers that currently that products identified on the list With regard to the applicability of the comply with existing laws.’’ Another should retain their status as end term ‘‘mobile,’’ FTA intended for it to commenter warned that adoption of the products, even if incorporated into a apply to all portable or moveable lifts, SNPRM’s language would have new system. One commenter, an hoists, and elevators. FTA did not ‘‘unintended consequences’’ on an elevator manufacturer, sought intend that permanently affixed lifts, ‘‘already fragile bus industry.’’ clarification that the adjective ‘‘mobile’’ hoists, and elevators would be Finally, commenters pointed out that in the representative list of considered as ‘‘end products.’’ Rather, the Dear Colleague letter’s definition of manufactured products applied to lifts, they will continue to be considered ‘‘final assembly’’ had been hoists, and elevators that were movable components of the larger facility, which acknowledged and memorialized by and not part of a facility’s permanent itself could constitute the ‘‘end Congress in section 3035 of TEA–21, infrastructure. product.’’ and Congress did not indicate any B. FTA Response direction for FTA to alter the current 5. Definition of ‘‘Final Assembly’’ definition of final assembly. FTA agrees with the commenters who In the first NPRM, FTA sought recommended FTA implement a comment on its proposal to amend the B. FTA Response ‘‘representative’’ list of end products for definition of ‘‘final assembly’’ in 49 CFR FTA finds the commenters two reasons: First, SAFETEA–LU part 661 for rolling stock procurements persuasive. Not only does the Dear directed the Secretary to ‘‘develop a list by incorporating the minimum Colleague letter reflect widespread of representative items that are subject requirements for final assembly as industry understanding of the final to the Buy America requirements’’ outlined in FTA’s March 18, 1997, Dear assembly process, it is a long-standing (emphasis added). By use of the term Colleague letter, C–97–03, which precedent that reflects industry input ‘‘representative’’ rather than Congress implemented through section and consensus and has been recognized ‘‘comprehensive,’’ FTA believes that 3035 of the Transportation Equity Act by Congress as an acceptable standard. Congress did not intend that the list be for the 21st Century (TEA–21) (Pub. L. Therefore, FTA is withdrawing the exhaustive. Second, FTA agrees that it 105–178). proposed language in the SNPRM and would be unrealistic and unnecessary to Several commenters recommended will instead continue to implement the develop a comprehensive list and keep several changes to the NPRM’s proposed terms of the March 18, 1997, Dear it constantly updated as some definition, suggesting that it be made Colleague letter, with a few minor commenters suggested. consistent with the descriptions of additions to reflect industry practices FTA believes it is impractical to incorporation and final assembly for rail that have taken effect after the 1997 attempt to produce an exhaustive cars and buses in 49 CFR 661.11(b) and Dear Colleague letter was issued, such comprehensive list of every conceivable (c). FTA concurred with these as the construction of bus shells and the end product, component, and commenters, agreeing that the definition installation of locomotive engines in subcomponent in the transit industry. of final assembly should refer back to 49 passenger railcars. The comprehensive lists offered by CFR 661.11(b) and (c) for the bus and commenters to the NPRM and SNPRM, 6. Communication, Train Control, and rail car components that must be Traction Power Equipment which were often very lengthy, highly incorporated into the end product at the detailed, and seldom uniform, illustrate final assembly location. FTA sought comment on three the difficulty of creating such a list. One FTA also agreed with a commenter substantive proposals to the Buy commenter stated that the suggested who recommended that language from America requirements for rolling stock lists of end products were not based the March 18, 1997, Dear Colleague components in the NPRM. In the first of upon the development of reasonable letter regarding FTA determinations of these proposals, FTA sought comment governing principles, but rather, ‘‘by compliance be added to the ‘‘final on whether it should continue to find parochial interests that are focused assembly’’ provisions. that the items of communication literally on a product by product basis.’’ equipment listed in 49 CFR 661.11 That commenter recommended that A. Comments Received include wayside equipment, i.e., FTA design its regulations around Although two transit agencies communication equipment that is not in principles that can be fairly and concurred with FTA’s approach without or on a vehicle, but on the adjacent impartially applied on a consistent basis providing substantive comments, the tracks or right-of-way. FTA also sought in a technologically complex and proposal was opposed by five rolling comment on whether the items of train constantly evolving environment. stock manufacturers, a large industry control, communication, and traction FTA believes that a more practical trade association, a consortium of power equipment listed in 49 CFR approach is to issue a representative list suppliers, and a consultant, all of whom 661.11(t), (u), and (v) should be deleted

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and whether any new items should be states that ‘‘[t]he power or third rail is with respect to Buy America added to these lists to reflect new not considered traction power requirements. technology. Finally, FTA sought equipment and is thus subject to the comment on whether the term requirements of 49 U.S.C. 5323(j) and B. Executive Order 12866 and DOT ‘‘communication equipment’’ should be the requirements of 49 CFR 661.5.’’ Regulatory Policies and Procedures limited to equipment whose primary FTA believes that these This final rule is a nonsignificant function is communication ‘‘with or recommendations go beyond the scope regulatory action under section 3(f) of between people’’ or whether it should of the present rulemaking. Currently, all Executive Order 12866 and, therefore, be expanded to include a ‘‘machine-to- power or third rails, regardless of was not reviewed by the Office of machine’’ interface. whether made primarily from Management and Budget. This final rule Based on comments received in aluminum, steel, or some other material, response to the NPRM, FTA determined is excluded from the definition of is also nonsignificant under the that the rolling stock requirements for ‘‘traction power equipment’’ and instead Regulatory Policies and Procedures of communications equipment would is subject to 49 CFR 661.5. If the rail is the Department of Transportation (44 FR continue to apply to wayside made of steel or iron, the product must 11034, Feb. 26, 1979). This final rule equipment. One commenter comply with 49 CFR 661.5(c). If BPTS imposes no new compliance costs on recommended deleting several items third rail is not made primarily of steel, the regulated industry; it merely from the proposed lists of train control, it would be treated as a manufactured clarifies terms existing in the Buy communication, and traction power product under 49 CFR 661.5(d). In order America regulations and adds terms equipment, but several more to provide a competitive and level consistent with SAFETEA–LU. commenters suggested the addition of playing field, FTA is interpreting the C. Executive Order 13132 items to the lists, which was reflected in commenters’ recommendations as a the SNPRM. With regard to the request to classify power or third rails This final rule has been analyzed in expansion of the term ‘‘communication as traction power equipment, whether accordance with the principles and equipment’’ to include machine-to- made of steel, aluminum, or some other criteria contained in Executive Order machine interactions, FTA noted in the material. This would require a SNPRM that modern communication 13132 (‘‘Federalism’’). This final rule Congressional action to exclude steel does not include any regulation that has networks frequently support both and iron contact rail from the domestic capabilities (i.e., human to human substantial direct effects on the States, manufacturing requirements of 661.5(c), the relationship between the national interaction and machine-to-machine which is beyond FTA’s authority in this government and the States, or the interface) and it would be difficult in rulemaking. those situations to determine which distribution of power and components of the communication 7. Statutory Update responsibilities among the various equipment was supporting one purpose The SNPRM proposed to amend the levels of government. Therefore, the or the other. Moreover, FTA’s review of debarment and suspension provisions in consultation and funding requirements prior Buy America decisions involving 49 CFR 661.18 to incorporate a reference of Executive Order 13132 do not apply. communication equipment supported to SAFETEA–LU, replacing the existing D. Executive Order 13175 these conclusions and FTA declined to reference to the Intermodal Surface make such a distinction in the SNPRM. Transportation Efficient Act of 1991 This final rule has been analyzed in However, the SNPRM stated that FTA (ISTEA). accordance with the principles and will continue to carefully scrutinize, on criteria contained in Executive Order a case-by-case basis, whether technology A. Comments Received 13175 (‘‘Consultation and Coordination may properly be characterized as Commenters were unanimous in their with Indian Tribal Governments’’). ‘‘communication equipment’’ within the support of the amendment. meaning of the rolling stock provisions Because this final rule does not have of 49 U.S.C. 5323(j) and 49 CFR 661.11. B. FTA Response tribal implications and does not impose direct compliance costs, the funding FTA is adopting the amendment A. Comments Received and consultation requirements of without change. FTA is also amending Two of the three commenters to the the statutory references to section 165 of Executive Order 13175 do not apply. SNPRM concurred with FTA’s the Surface Transportation Assistance E. Regulatory Flexibility Act and approach. One commenter, a large Act of 1982 in 49 CFR 661.6 and 661.12 Executive Order 13272 transit agency, believed that further and replacing them with references to modification was necessary to reflect the current Buy America requirements The Regulatory Flexibility Act (5 current technology and practices— at 49 U.S.C. 5323(j). In addition, FTA is U.S.C. 601–611) requires each agency to namely, that propulsion systems and amending the title of 49 Part 661 to analyze regulations and proposals to cab display should be added to the list remove the reference to the Surface assess their impact on small businesses of traction power equipment. Transportation Assistance Act of 1982 and other small entities to determine B. FTA Response so that the title will simply read, ‘‘Buy whether the rule or proposal will have FTA notes that several commenters America Requirements.’’ a significant economic impact on a recommended that aluminum composite II. Regulatory Analyses and Notices substantial number of small entities. conducting rail, otherwise known as This final rule imposes no significant Bimetallic Power Transmission (BPTS) A. Statutory/Legal Authority for This new costs on small entities, and in fact, Equipment, which is a combination of Rulemaking is expected to reduce costs by an aluminum conductor and a stainless This final rule is authorized under eliminating specific recordkeeping steel abrasion-resistant cap, be added to SAFETEA–LU (Pub. L. 109–59), which burdens. Therefore, FTA certifies that the list of traction power equipment in amended Section 5323(j) and (m) of this proposal does not require further 49 CFR 661.11(v). However, FTA’s Title 49, United States Code and analysis under the Regulatory current regulation at 49 CFR 661.11(w) required FTA to revise its regulations Flexibility Act.

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F. Unfunded Mandates Reform Act of Authority: 49 U.S.C. 5323(j) (formerly sec. System means a machine, product, or 1995 165 of the Surface Transportation Assistance device, or a combination of such Act of 1982 (Pub. L. 97–424); as amended by This final rule does not propose equipment, consisting of individual sec. 337, Pub. L. 100–17; sec. 1048, Pub. L. components, whether separate or unfunded mandates under the 102–240; sec. 3020(b), Pub. L. 105–178; and Unfunded Mandates Reform Act of sec. 3023(i) and (k), Pub. L. 109–59); 49 CFR interconnected by piping, transmission 1995. If the proposals are adopted into 1.51. devices, electrical cables or circuitry, or a final rule, it will not result in costs of by other devices, which are intended to I 2. The heading for part 661 is revised $100 million or more (adjusted annually contribute together to a clearly defined to read as set forth above. for inflation), in the aggregate, to any of function. Factors to consider in the following: State, local, or Native § 661.1 [Amended]. determining whether a system constitutes an end product include: American tribal governments, or the I 3. Amend § 661.1 by removing private sector. Whether performance warranties apply ‘‘Federal Mass Transit Act of 1964, as to an integrated system (regardless of G. Paperwork Reduction Act amended’’ and adding in its place ‘‘49 whether components are separately This final rule proposes no new U.S.C. 5323(j)’’. warranteed); whether products perform information collection requirements. I 4. Revise § 661.3 to read as follows: on an integrated basis with other products in a system, or are operated § 661.3 Definitions. H. Regulation Identifier Number (RIN) independently of associated products in A regulation identifier number (RIN) As used in this part: the system; or whether transit agencies is assigned to each regulatory action Act means the Federal Public routinely procure a product separately listed in the Unified Agenda of Federal Transportation Law (49 U.S.C. Chapter (other than as replacement or spare Regulations. The Regulatory Information 53). parts). Administrator means the Service Center publishes the Unified United States means the several Administrator of FTA, or designee. Agenda in April and October of each States, the Commonwealth of Puerto Component means any article, year. The RIN number contained in the Rico, the District of Columbia, Guam, material, or supply, whether heading of this document may be used American Samoa, the U.S. Virgin manufactured or unmanufactured, that to cross-reference this action with the Islands, and the Commonwealth of the is directly incorporated into the end Unified Agenda. Northern Mariana Islands. product at the final assembly location. I. Environmental Assessment Contractor means a party to a third Appendix A to § 661.3—End Products The National Environmental Policy party contract other than the grantee. The following is a list of representative end End product means any vehicle, Act of 1969 (NEPA), as amended (42 products that are subject to the requirements structure, product, article, material, U.S.C. 4321–4347), requires Federal of Buy America. This list is representative, supply, or system, which directly agencies to consider the consequences not exhaustive. incorporates constituent components at (1) Rolling stock end products: All of major Federal actions and prepare a the final assembly location, that is individual items identified as rolling stock in detailed statement on actions acquired for public use under a § 661.3 (e.g., buses, vans, cars, railcars, significantly affecting the quality of the federally-funded third-party contract, locomotives, trolley cars and buses, ferry human environment. There are no and which is ready to provide its boats, as well as vehicles used for support significant environmental impacts services); train control, communication, and intended end function or use without associated with this final rule. traction power equipment that meets the any further manufacturing or assembly definition of end product at § 661.3 (e.g., a J. Privacy Act change(s). A list of representative end communication or traction power system). Anyone is able to search the products is included at Appendix A to (2) Steel and iron end products: Items electronic form for all comments this section. made primarily of steel or iron such as received into any of our dockets by the FTA means the Federal Transit structures, bridges, and track work, including running rail, contact rail, and turnouts. name of the individual submitting the Administration. Grantee means any entity that is a (3) Manufactured end products: comments (or signing the comment, if Infrastructure projects not made primarily of submitted on behalf of an association, recipient of FTA funds. Manufactured product means an item steel or iron, including structures (terminals, business, labor union, etc.). You may produced as a result of the depots, garages, and bus shelters), ties and review DOT’s complete Privacy Act ballast; contact rail not made primarily of manufacturing process. Statement in the Federal Register steel or iron; fare collection systems; Manufacturing process means the published on April 11, 2000 (Volume computers; information systems; security application of processes to alter the 65, Number 70; Pages 19477–78) or you systems; data processing systems; and mobile form or function of materials or of may visit http://dms.dot.gov. lifts, hoists, and elevators. elements of the product in a manner List of Subjects in 49 CFR Part 661 adding value and transforming those § 661.6 [Amended] I Grant programs—transportation, materials or elements so that they 5. Amend § 661.6 as follows: I Public transportation, Reporting and represent a new end product a. Remove ‘‘Certificate of Compliance recordkeeping requirements. functionally different from that which With Section 165(a)’’ and add in its place ‘‘Certificate of Compliance with I would result from mere assembly of the Accordingly, for the reasons described elements or materials. Buy America Requirements’’ and in the preamble, part 661 of the Code of Negotiated procurement means a remove ‘‘section 165(a) of the Surface Federal Regulations is amended as contract awarded using other than Transportation Assistance Act of 1982, follows: sealed bidding procedures. as amended’’ and add in its place ‘‘49 PART 661—BUY AMERICA Rolling stock means transit vehicles U.S.C. 5323(j)(1)’’. I REQUIREMENTS such as buses, vans, cars, railcars, b. Remove ‘‘Certificate for Non- locomotives, trolley cars and buses, and Compliance with Section 165(a)’’ and I 1. The authority citation for part 661 ferry boats, as well as vehicles used for add in its place ‘‘Certificate of Non- is amended to read as follows: support services. Compliance with Buy America

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Requirements’’, remove ‘‘section 165(a) availability waiver only if the grantee (21) Communications Control Units; of the Surface Transportation Assistance provides sufficient evidence that the (22) Communication Control Heads; Act of 1982, as amended’’ and add in its original certification was made in good (23) Wireless Intercar Transceivers; place ‘‘49 U.S.C. 5323(j)’’, and remove faith and that the item to be procured (24) Multiplexers; ‘‘section 165(b)(2) or (b)(4) of the cannot now be obtained domestically (25) SCADA Systems; Surface Transportation Assistance Act due to commercial impossibility or (26) LED Arrays; of 1982’’ and add in its place ‘‘49 U.S.C. impracticability. In determining (27) Screen Displays such as LEDs 5323(j)(2)’’. whether the conditions exist to grant a and LCDs for communication systems; I 6. Amend § 661.7 as follows: post-award non-availability waiver, the (28) Fiber-optic transmission I a. In paragraph (a), remove ‘‘Section Administrator will consider all equipment; 165(b) of the Act’’ and add in its place appropriate factors on a case-by-case (29) Fiber-optic transmission ‘‘Section 5323(j)(2) of Title 49 United basis. equipment; States Code’’ and remove ‘‘section * * * * * (30) Frame or cell based multiplexing 165(a)’’ and add in its place ‘‘49 U.S.C. equipment; 13) Communication system 5323(j)(1)’’. Appendix A to § 661.7—General network elements. I b. Revise paragraph (b); Waivers (v) * * * I c. Amend paragraph (c) by removing * * * * * (28) Propulsion Control Systems; ‘‘section 165(b)(2) of the Act’’ and (b) Under the provisions of § 661.7 (b) and (29) Surge Arrestors; adding in its place ‘‘49 U.S.C. (c) of this part, a general public interest (30) Protective Relaying. 5323(j)(2)’’ and removing ‘‘section waiver from the Buy America requirements * * * * * 165(a)’’ and adding in its place ‘‘49 applies to microprocessors, computers, U.S.C. 5323(j)’’; microcomputers, or software, or other such Appendix D to § 661.11—Minimum I d. Add a new paragraph (c)(3); devices, which are used solely for the Requirements for Final Assembly I e. Amend paragraph (e) by removing purpose of processing or storing data. This general waiver does not extend to a product (a) Rail Cars: In the case of the manufacture ‘‘section 165(b) of the Act’’ and adding or device which merely contains a of a new, remanufactured, or overhauled rail in its place ‘‘49 U.S.C. 5323(j)(2)’’; microprocessor or microcomputer and is not car, final assembly would typically include, I f. Amend paragraph (f) by removing used solely for the purpose of processing or as a minimum, installation and ‘‘section 165(b)(3) of the Act’’ and storing data. interconnection of the typical Rail Car Components listed in § 661.11, Appendix C, adding in its place ‘‘49 U.S.C. * * * * * 5323(j)(2)(C)’’; and including but not limited to the following I I g. Amend Appendix A to § 661.7 by 7. Amend § 661.9(a) by removing items: car bodies or shells, chassis, carbody removing paragraphs (b) and (c) and ‘‘section 165(b)(3) of the Act’’ and wiring, car-borne power plants or power adding new paragraph (b). ‘‘section 165(b)(3)’’ and adding in their pick-up equipment, energy management and storage devices, articulation equipment, The revisions and addition read as place ‘‘49 U.S.C. 5323(j)(2)(C)’’. I propulsion control equipment, propulsion follows: 8. Amend § 661.11 as follows: cooling equipment, friction brake equipment, I a. Remove and reserve paragraph (s). § 661.7 Waivers. energy sources for auxiliary equipment and I b. Add paragraphs (t)(14) through controls, heating and air conditioning * * * * * (t)(22), (u)(18) through (u)(30), and equipment, interior and exterior lighting (b) Under the provision of 49 U.S.C. (v)(28) through (30); equipment, coupler equipment and coupler 5323(j)(2)(A), the Administrator may I c. Amend Appendix B by adding ‘‘Car control system, communications equipment, waive the general requirements of 49 body shells’’ before ‘‘Engines’’; pneumatic systems, electrical systems, door U.S.C. 5323(j)(1) if the Administrator I d. Amend Appendix C by adding and door control systems, passenger seats, finds that their application would be ‘‘engines’’ after ‘‘Car shells’’ and remove passenger interiors, cab interiors, destination inconsistent with the public interest. In ‘‘doors, door actuators, and controls,’’ signs, wheelchair lifts (or other equipment determining whether the conditions required to make the vehicle accessible to and add in its place ‘‘doors, door persons with disabilities), motors, wheels, exist to grant this public interest waiver, actuators and controls, wheelchair lifts axles, gear boxes or integrated motor/gear the Administrator will consider all and ramps to make the vehicle units, suspensions, and truck frames. Final appropriate factors on a case-by-case accessible to persons with disabilities,’’; Assembly activities shall also include the basis, unless a general exception is and inspection and verification of all installation specifically set out in this part. When I e. Add a new Appendix D. and interconnection work; and the in-plant granting a public interest waiver, the The additions read as follows: testing of the rail car to verify all functions. Administrator shall issue a detailed In the case of articulated vehicles, the written statement justifying why the § 661.11 Rolling stock procurements. interconnection of the car bodies or shells waiver is in the public interest. The * * * * * shall be included as work to be performed by (t) * * * the manufacturer as part of vehicle delivery. Administrator shall publish this (b) Buses: In the case of a new, justification in the Federal Register, (14) Cab Signaling; remanufactured, or overhauled bus, final providing the public with a reasonable (15) ATO Equipment; assembly would typically include, at a time for notice and comment of not (16) ATP Equipment; minimum, the installation and more than seven calendar days. (17) Wayside Transponders; interconnection of the typical Bus (c) * * * (18) Trip Stop Equipment; Components listed in § 661.11, Appendix B, (3) After contract award, the (19) Wayside Magnets; including but not limited to the following Administrator may grant a non- (20) Speed Measuring Devices; items: car bodies or shells, the engine and availability waiver under this (21) Car Axle Counters; transmission (drive train), axles, energy paragraph, in any case in which a (22) Communication Based Train management and storage devices, articulation equipment, propulsion control system, bidder or offeror originally certified Control (CBTC). chassis, and wheels, cooling system, and compliance with the Buy America (u) * * * braking systems; the installation and requirements in good faith, but can no (18) Antennas; interconnection of the heating and air longer comply with its certification. The (19) Wireless Telemetry Equipment; conditioning equipment; the installation of Administrator will grant a non- (20) Passenger Information Displays; pneumatic system and the electrical system,

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door systems, passenger seats, passenger grab § 661.12 [Amended] Assistance Act of 1982, as amended’’ rails, destination signs, wheelchair lifts or and add in its place ‘‘49 U.S.C. 5323(j)’’; I 9. Amend § 661.12 as follows: ramps and other equipment required to make and remove ‘‘section 165(b)(2) or (b)(4) I the vehicle accessible to persons with a. Remove ‘‘Certificate of Compliance of the Surface Transportation Assistance disabilities, and road testing. Final Assembly With Section 165(b)(3)’’ and add in its Act of 1982’’ and add in its place ‘‘49 activities shall also include final inspection, place ‘‘Certificate of Compliance with U.S.C. 5323(j)(2)(C)’’. repairs and preparation of the vehicles for Buy America Rolling Stock delivery. In the case of articulated vehicles, Requirements’’ and remove ‘‘section § 661.18 [Amended] the interconnection of the car bodies or shells 165(b)(3) of the Surface Transportation I 10. Amend the introductory text by shall be included as work to be performed by Assistance Act of 1982, as amended’’ the manufacturer as part of vehicle delivery. removing ‘‘the Intermodal Surface and add in its place ‘‘49 U.S.C. 5323(j)’’ Transportation Efficiency Act of 1991’’ (c) If a manufacturer’s final assembly and processes do not include all the activities and adding in its place ‘‘the Federal I that are typically considered the minimum b. Remove ‘‘Certificate for Non- Public Transportation Act of 2005’’. requirements, it can request a Federal Transit Compliance with Section 165(b)(3)’’ and James S. Simpson, Administration (FTA) determination of add in its place ‘‘Certificate of Non- compliance. FTA will review these requests Compliance with Buy America Rolling Administrator. on a case-by-case basis to determine Stock Requirements’’; remove ‘‘section [FR Doc. E7–18355 Filed 9–19–07; 8:45 am] compliance with Buy America. 165(b)(3) of the Surface Transportation BILLING CODE 4910–57–P

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Proposed Rules Federal Register Vol. 72, No. 182

Thursday, September 20, 2007

This section of the FEDERAL REGISTER • Hand Delivery: Room W12–140 on dated June 12, 2007 (referred to after contains notices to the public of the proposed the ground floor of the West Building, this as ‘‘the MCAI’’), to correct an unsafe issuance of rules and regulations. The 1200 New Jersey Avenue, SE., condition for the specified products. purpose of these notices is to give interested Washington, DC, between 9 a.m. and 5 The MCAI states: persons an opportunity to participate in the p.m., Monday through Friday, except rule making prior to the adoption of the final After push back from the gate, an A320– Federal holidays. rules. • 200 aircraft was preparing to initiate taxi, Federal eRulemaking Portal: http:// when a NLG (nose landing gear) www.regulations.gov. Follow the uncommanded retraction occurred, and then DEPARTMENT OF TRANSPORTATION instructions for submitting comments. the aircraft abruptly hit the ground. Examining the AD Docket Investigations revealed that the retract Federal Aviation Administration condition is caused by a combination of a You may examine the AD docket on faulty MLG (main landing gear) proximity 14 CFR Part 39 the Internet at http://dms.dot.gov; or in switch, a power interruption to LGCIUs person at the Docket Operations office (Landing Gear Control and Interface Units) [Docket No. FAA–2007–29249; Directorate between 9 a.m. and 5 p.m., Monday and an internal hydraulic leak through the Identifier 2007–NM–112–AD] through Friday, except Federal holidays. LG (landing gear) selector valve 40GA. The RIN 2120–AA64 The AD docket contains this proposed internal hydraulic leak through the LG AD, the regulatory evaluation, any selector valve 40GA was due to a broken seal Airworthiness Directives; Airbus Model comments received, and other in one of the end cap chambers for the valve A318, A319, A320, and A321 Series information. The street address for the spool. As a corrective action, a duplicate inspection (DI or DI–BE) for these valves has Airplanes Docket Operations office (telephone been introduced in production, and the ADDRESSES AGENCY: Federal Aviation (800) 647–5527) is in the Component Maintenance Manual (CMM) has Administration (FAA), DOT. section. Comments will be available in been revised. Untimely unlocking and/or the AD docket shortly after receipt. ACTION: Notice of proposed rulemaking retraction of the NLG, while on the ground, (NPRM). FOR FURTHER INFORMATION CONTACT: Tim could cause injury to ground personnel and Dulin, Aerospace Engineer, significant structural damage to the aircraft. SUMMARY: We propose to adopt a new International Branch, ANM–116, FAA, This Airworthiness Directive (AD) airworthiness directive (AD) for the Transport Airplane Directorate, 1601 mandates the inspections of the LG selector products listed above. This proposed Lind Avenue, SW., Renton, Washington valve 40GA and the LG door selector valve AD results from mandatory continuing 98057–3356; telephone (425) 227–2141; 41GA, to identify a possible hydraulic leak. airworthiness information (MCAI) fax (425) 227–1149. The corrective action includes replacing originated by an aviation authority of SUPPLEMENTARY INFORMATION: the LG selector valve 40GA and/or the another country to identify and correct LG door selector valve 41GA if an unsafe condition on an aviation Comments Invited necessary. You may obtain further product. The MCAI describes the unsafe We invite you to send any written information by examining the MCAI in condition as: relevant data, views, or arguments about the AD docket. After a push back from the gate, an A320– this proposed AD. Send your comments 200 aircraft was preparing to initiate taxi, to an address listed under the Relevant Service Information when a NLG (nose landing gear) ADDRESSES section. Include ‘‘Docket No. uncommanded retraction occurred, and then FAA–2007–29249; Directorate Identifier Airbus has issued Service Bulletin the aircraft abruptly hit the ground. 2007–NM–112–AD’’ at the beginning of A320–32–1290, Revision 01, dated * * * Untimely unlocking and/or your comments. We specifically invite November 10, 2006. The actions retraction of the NLG, while on the ground, comments on the overall regulatory, described in this service information are could cause injury to ground personnel and intended to correct the unsafe condition significant structural damage to the airplane. economic, environmental, and energy aspects of this proposed AD. We will identified in the MCAI. The proposed AD would require consider all comments received by the FAA’s Determination and Requirements actions that are intended to address the closing date and may amend this of This Proposed AD unsafe condition described in the MCAI. proposed AD based on those comments. DATES: We must receive comments on We will post all comments we This product has been approved by this proposed AD by October 22, 2007. receive, without change, to http:// the aviation authority of another ADDRESSES: You may send comments by dms.dot.gov, including any personal country, and is approved for operation any of the following methods: information you provide. We will also in the United States. Pursuant to our • DOT Docket Web Site: Go to post a report summarizing each bilateral agreement with the State of http://dms.dot.gov and follow the substantive verbal contact we receive Design Authority, we have been notified instructions for sending your comments about this proposed AD. of the unsafe condition described in the electronically. MCAI and service information • Fax: (202) 493–2251. Discussion referenced above. We are proposing this • Mail: U.S. Department of The European Aviation Safety Agency AD because we evaluated all pertinent Transportation, Docket Operations, M– (EASA), which is the Technical Agent information and determined an unsafe 30, West Building Ground Floor, Room for the Member States of the European condition exists and is likely to exist or W12–140, 1200 New Jersey Avenue, SE., Community, has issued EASA develop on other products of the same Washington, DC 20590. Airworthiness Directive 2007–0065R1, type design.

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Differences Between This AD and the For the reasons discussed above, I Reason MCAI or Service Information certify this proposed regulation: (e) The mandatory continuing We have reviewed the MCAI and 1. Is not a ‘‘significant regulatory airworthiness information (MCAI) states: related service information and, in action’’ under Executive Order 12866; After push back from the gate, an A320– general, agree with their substance. But 2. Is not a ‘‘significant rule’’ under the 200 aircraft was preparing to initiate taxi, we might have found it necessary to use DOT Regulatory Policies and Procedures when a NLG (nose landing gear) different words from those in the MCAI (44 FR 11034, February 26, 1979); and uncommanded retraction occurred, and then the aircraft abruptly hit the ground. to ensure the AD is clear for U.S. 3. Will not have a significant economic impact, positive or negative, Investigations revealed that the retract operators and is enforceable. In making condition is caused by a combination of a these changes, we do not intend to differ on a substantial number of small entities faulty MLG (main landing gear) proximity substantively from the information under the criteria of the Regulatory switch, a power interruption to LGCIUs provided in the MCAI and related Flexibility Act. (Landing Gear Control and Interface Units) service information. We prepared a regulatory evaluation and an internal hydraulic leak through the We might also have proposed of the estimated costs to comply with LG (landing gear) selector valve 40GA. The different actions in this AD from those this proposed AD and placed it in the internal hydraulic leak through the LG in the MCAI in order to follow FAA AD docket. selector valve 40GA was due to a broken seal policies. Any such differences are in one of the end cap chambers for the valve highlighted in a NOTE within the List of Subjects in 14 CFR Part 39 spool. As a corrective action, a duplicate inspection (DI or DI–BE) for these valves has proposed AD. Air transportation, Aircraft, Aviation been introduced in production, and the Costs of Compliance safety, Safety. Component Maintenance Manual (CMM) has The Proposed Amendment been revised. Untimely unlocking and/or Based on the service information, we retraction of the NLG, while on the ground, estimate that this proposed AD would Accordingly, under the authority could cause injury to ground personnel and affect about 653 products of U.S. delegated to me by the Administrator, significant structural damage to the aircraft. registry. We also estimate that it would the FAA proposes to amend 14 CFR part This Airworthiness Directive (AD) take about 7 work-hours per product to 39 as follows: mandates the inspections of the LG selector comply with the basic requirements of valve 40GA and the LG door selector valve this proposed AD. The average labor PART 39—AIRWORTHINESS 41GA, to identify a possible hydraulic leak. rate is $80 per work-hour. Based on DIRECTIVES The corrective action includes replacing the these figures, we estimate the cost of the LG selector valve 40GA and/or the LG door proposed AD on U.S. operators to be 1. The authority citation for part 39 selector valve 41GA if necessary. $365,680, or $560 per product. continues to read as follows: Actions and Compliance Authority for This Rulemaking Authority: 49 U.S.C. 106(g), 40113, 44701. (f) Unless already done, do the following actions. § 39.13 [Amended] Title 49 of the United States Code (1) For aircraft that have accumulated up specifies the FAA’s authority to issue 2. The FAA amends § 39.13 by adding to and including 20,000 total flight cycles as rules on aviation safety. Subtitle I, the following new AD: of the effective date of this AD: Within 4,500 section 106, describes the authority of Airbus: Docket No. FAA–2007–29249; flight cycles after the effective date of this the FAA Administrator. ‘‘Subtitle VII: Directorate Identifier 2007–NM–112–AD. AD, but not exceeding 20,800 total flight Aviation Programs,’’ describes in more cycles, inspect for hydraulic leaking of the detail the scope of the Agency’s Comments Due Date LG selector valve 40GA and the LG door authority. (a) We must receive comments by October selector valve 41GA and replace if necessary We are issuing this rulemaking under 22, 2007. the LG selector valve 40GA and the LG door the authority described in ‘‘Subtitle VII, selector valve 41GA before further flight in Affected ADs accordance with the Accomplishment Part A, Subpart III, Section 44701: (b) None. Instructions of Airbus Service Bulletin A320– General requirements.’’ Under that 32–1290, Revision 01, dated November 10, section, Congress charges the FAA with Applicability 2006. promoting safe flight of civil aircraft in (c) This AD applies to Airbus Model A318, (2) For aircraft that have accumulated over air commerce by prescribing regulations A319, A320, and A321 series airplanes, 20,000 total flight cycles as of the effective for practices, methods, and procedures certificated in any category, except those date of this AD: Within 800 flight cycles after the Administrator finds necessary for identified in paragraphs (c)(1) and (c)(2) of the effective date of this AD, inspect for safety in air commerce. This regulation this AD. hydraulic leaking of the LG selector valve is within the scope of that authority (1) Manufacturer serial numbers (MSNs) 40GA and the LG door selector valve 41GA and replace if necessary the LG selector valve because it addresses an unsafe condition 2389, 2392, 2393, 2396, 2398, 2403, 2405, 2407, 2409, 2410, 2411, 2413 through 2439, 40GA and the LG door selector valve 41GA that is likely to exist or develop on 2441, and MSNs above 2441, on which no before further flight in accordance with the products identified in this rulemaking replacement of the landing gear (LG) selector Accomplishment Instructions of Airbus action. valve 40GA or the LG door selector valve Service Bulletin A320–32–1290, Revision 01, dated November 10, 2006. Regulatory Findings 41GA has been performed since aircraft delivery from Airbus. (3) For all airplanes: Repeat the inspection We determined that this proposed AD (2) Aircraft on which LG selector valve specified in paragraph (f)(1) or (f)(2) of this would not have federalism implications 40GA and LG door selector valve 41GA have AD, as applicable, thereafter at intervals not under Executive Order 13132. This been stamped to indicate that a duplicate to exceed 20,000 flight cycles, or 89 months, proposed AD would not have a inspection has been done. If the duplicate whichever occurs first, and replace if substantial direct effect on the States, on inspection has been done, the amendment necessary (i.e., if any leakage is found) the LG selector valve 40GA and the LG door selector the relationship between the national plates on the valves will be stamped with letters ‘‘DI’’ or ‘‘DI-BE.’’ valve 41GA before further flight, in Government and the States, or on the accordance with the Accomplishment distribution of power and Subject Instructions of Airbus Service Bulletin A320– responsibilities among the various (d) Air Transport Association (ATA) of 32–1290, Revision 01, dated November 10, levels of government. America Code 32: Landing Gear. 2006.

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(4) For all airplanes: From the effective DEPARTMENT OF TRANSPORTATION • Hand Delivery: Room W12–140 on date of this AD, the installation of LG selector the ground floor of the West Building, valve 40GA or LG door selector valve 41GA, Federal Aviation Administration 1200 New Jersey Avenue, SE., that do not have the duplicate inspection Washington, DC, between 9 a.m. and 5 ‘‘DI’’ or ‘‘DI-BE’’ recorded on their 14 CFR Part 39 p.m., Monday through Friday, except amendment plates, is possible provided that it is inspected within 800 flight cycles after [Docket No. FAA–2007–29259; Directorate Federal holidays. installation, in accordance with the Identifier 2007–NM–195–AD] Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, instructions given in Airbus Service Bulletin RIN 2120–AA64 A320–32–1290, Revision 01, dated November Washington 98124–2207, for service 10, 2006. Repeat the inspection thereafter as Airworthiness Directives; Boeing information identified in this proposed given in paragraph (f)(3) of this AD. Model 767 Airplanes AD. (5) Actions done before the effective date FOR FURTHER INFORMATION CONTACT: of this AD in accordance with Airbus Service AGENCY: Federal Aviation Tamara Anderson, Aerospace Engineer, Bulletin A320–32–1290, dated May 2, 2006, Administration (FAA), Department of Airframe Branch, ANM–120S, FAA, are acceptable for compliance with the Transportation (DOT). corresponding actions of this AD. Seattle Aircraft Certification Office, ACTION: Notice of proposed rulemaking 1601 Lind Avenue, SW., Renton, FAA AD Differences (NPRM). Washington 98057–3356; telephone Note: This AD differs from the MCAI and/ (425) 917–6421; fax (425) 917–6590. SUMMARY: The FAA proposes to or service information as follows: No SUPPLEMENTARY INFORMATION: differences. supersede an existing airworthiness directive (AD) that applies to all Boeing Comments Invited Other FAA AD Provisions Model 767 airplanes. The existing AD We invite you to submit any relevant (g) The following provisions also apply to currently requires repetitive written data, views, or arguments this AD: measurements of the rudder and regarding this proposed AD. Send your (1) Alternative Methods of Compliance elevator freeplay, repetitive lubrications comments to an address listed in the (AMOCs): The Manager, International of rudder and elevator components, and ADDRESSES section. Include the docket Branch, Transport Airplane Directorate, related investigative/corrective actions number ‘‘Docket No. FAA–2007–29259; ANM–116, FAA, has the authority to approve if necessary. This proposed AD would Directorate Identifier 2007–NM–195– AMOCs for this AD, if requested using the instead require revised repetitive procedures found in 14 CFR 39.19. Send AD’’ at the beginning of your comments. measurements of the rudder freeplay We specifically invite comments on the information to ATTN: Tim Dulin, Aerospace and the elevator freeplay for each of the Engineer, International Branch, ANM–116, overall regulatory, economic, FAA, Transport Airplane Directorate, 1601 power control actuators (PCAs) that environmental, and energy aspects of Lind Avenue, SW., Renton, Washington move the rudder and elevator, corrective the proposed AD. We will consider all 98057–3356; telephone (425) 227–2141; fax and related investigative actions if comments received by the closing date (425) 227–1149. Before using any approved necessary, and repetitive lubrications of and may amend the proposed AD in AMOC on any airplane to which the AMOC the rudder and elevator components. light of those comments. applies, notify your appropriate principal For some airplanes, this proposed AD We will post all comments we inspector (PI) in the FAA Flight Standards would also require related concurrent receive, without change, to http:// District Office (FSDO), or lacking a PI, your actions. This proposed AD results from local FSDO. dms.dot.gov, including any personal reports of freeplay-induced vibration of information you provide. We will also (2) Airworthy Product: For any requirement the rudder and the elevator. The in this AD to obtain corrective actions from post a report summarizing each potential for vibration of the control substantive verbal contact with FAA a manufacturer or other source, use these surface should be avoided because the actions if they are FAA-approved. Corrective personnel concerning this proposed AD. actions are considered FAA-approved if they point of transition from vibration to Using the search function of that Web are approved by the State of Design Authority divergent flutter is unknown. We are site, anyone can find and read the (or their delegated agent). You are required proposing this AD to prevent excessive comments in any of our dockets, to assure the product is airworthy before it vibration of the airframe during flight, including the name of the individual is returned to service. which could result in loss of control of who sent the comment (or signed the (3) Reporting Requirements: For any the airplane. comment on behalf of an association, reporting requirement in this AD, under the DATES: We must receive comments on business, labor union, etc.). You may provisions of the Paperwork Reduction Act, this proposed AD by October 22, 2007. the Office of Management and Budget (OMB) review the DOT’s complete Privacy Act has approved the information collection ADDRESSES: Use one of the following Statement in the Federal Register requirements and has assigned OMB Control addresses to submit comments on this published on April 11, 2000 (65 FR Number 2120–0056. proposed AD. 19477–78), or may can visit http:// • DOT Docket Web site: Go to dms.dot.gov. Related Information http://dms.dot.gov and follow the Examining the Docket (h) Refer to MCAI EASA Airworthiness instructions for sending your comments Directive 2007–0065R1, dated June 12, 2007, electronically. You may examine the AD docket on and Airbus Service Bulletin A320–32–1290, • Government-wide rulemaking Web the Internet at http://dms.dot.gov, or in Revision 01, dated November 10, 2006, for person at the Docket Operations office related information. site: Go to http://www.regulations.gov and follow the instructions for sending between 9 a.m. and 5 p.m., Monday Issued in Renton, Washington, on your comments electronically. through Friday, except Federal holidays. September 10, 2007. • Mail: U.S. Department of The Docket Operations office (telephone Ali Bahrami, Transportation, Docket Operations, M– (800) 647–5527) is located on the Manager, Transport Airplane Directorate, 30, West Building Ground Floor, Room ground level of the West Building at the Aircraft Certification Service. W12–140, 1200 New Jersey Avenue, SE., DOT street address stated in the [FR Doc. E7–18540 Filed 9–19–07; 8:45 am] Washington, DC 20590. ADDRESSES section. Comments will be BILLING CODE 4910–13–P • Fax: (202) 493–2251. available in the AD docket shortly after

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the Docket Management System receives information for accomplishing adequately address the unsafe them. concurrent actions on certain airplanes. condition. This proposed AD would not affect any Discussion of the requirements of AD 2001–04–09. FAA’s Determination and Requirements On May 17, 2006, we issued AD of the Proposed AD 2006–11–12, amendment 39–14616 (71 Relevant Service Information We have evaluated all pertinent FR 30272, May 26, 2006), for all Boeing We have reviewed Boeing Special Model 767 airplanes. That AD requires Attention Service Bulletins 767–27– information and identified an unsafe repetitive measurements of the rudder 0197, Revision 1, dated July 19, 2007 condition that is likely to develop on and elevator freeplay, repetitive (for Model 767–200, –300, and –300F other airplanes of the same type design. lubrication of rudder and elevator series airplanes); and 767–27–0198, For this reason, we are proposing this components, and related investigative/ Revision 1, dated July 19, 2007 (for AD, which would supersede AD 2006– corrective actions if necessary. That AD Model 767–400ER series airplanes). The 11–12. This proposed AD would require resulted from reports of freeplay- service bulletins describe improved accomplishing the actions specified in induced vibration of the rudder and the procedures for repetitive measurements the special attention service bulletins elevator. We issued that AD to prevent of the rudder freeplay and the elevator described previously, except as excessive vibration of the airframe freeplay for each of the PCAs that move discussed under ‘‘Differences Between during flight, which could result in loss the rudder and elevator. For freeplay the Proposed AD and the Special of control of the airplane. that exceeds certain specified limits, the Attention Service Bulletins.’’ service bulletins describe procedures for Actions Since Existing AD Was Issued Differences Between the Proposed AD doing applicable related corrective and Since we issued AD 2006–11–12, we and the Special Attention Service related investigative actions. Corrective Bulletins have learned that the procedures in and related investigative actions include Boeing Special Attention Service repairing or replacing all applicable Although Revision 1 of Boeing Bulletins 767–27–0197 and 767–27– affected parts if necessary, and repeating Special Attention Service Bulletins 767– 0198, both dated October 27, 2005 the freeplay measurement, until the 27–0197 and 767–27–0198 recommends (referred to in the existing AD as the freeplay is within acceptable limits. accomplishing the initial rudder and appropriate sources of service Affected parts may include worn or elevator freeplay measurements within information for accomplishing the loose hanger links, reaction links, PCA 18 months after the date on the service actions required by that AD), yielded rod ends, and trunnion connections that bulletins, the proposed AD would false-positive results for the contribute to the freeplay. The service require a compliance time of 12 months measurements of the rudder and bulletins also describe procedures and after the effective date of the AD. We elevator freeplay. The service bulletin repetitive intervals for repetitive have determined that 18 months would instructions for measuring the freeplay lubrication of the rudder and elevator not address the identified unsafe also did not include information on components that are the same as those condition soon enough to ensure an certain prior or concurrent actions to be described in the original issues of the adequate level of safety for the affected performed on certain airplanes. service bulletins. fleet. In developing an appropriate Therefore, we have determined that the For certain Model 767–200, –300, and compliance time for this proposed AD, requirements of AD 2006–11–12 do not –300F series airplanes, Boeing Special we considered the degree of urgency adequately address the identified unsafe Attention Service Bulletin 767–27– associated with the subject unsafe condition. 0197, Revision 1, specifies prior or condition, and the possibility that this Other Relevant Rulemaking concurrent accomplishment of Boeing proposed AD could extend the Alert Service Bulletin 767–27A0168, On February 21, 2001, we issued AD compliance time for airplanes on which dated November 21, 2000, which the measurements required in AD 2006– 2001–04–09, amendment 39–12128 (66 describes, among other actions, FR 13227, March 5, 2001). That AD 11–12 have not been accomplished. In procedures for inspecting the elevator light of these factors, we find that 12 requires repetitively testing the elevator bellcranks for any shear rivets that are control system to determine if an months represents an appropriate broken or yielded. interval of time for affected airplanes to elevator power control actuator (PCA) is For certain Model 767–400ER series continue to operate without rigged incorrectly due to yielded or airplanes, Boeing Special Attention compromising safety. This difference failed shear rivets in a bellcrank Service Bulletin 767–27–0198, Revision has been coordinated with Boeing. assembly, and follow-on actions, if 1, specifies prior or concurrent necessary. That AD refers to Boeing accomplishment of Boeing Alert Service Costs of Compliance Alert Service Bulletins 767–27A0168 Bulletin 767–27A0169, dated November and 767–27A0169, both dated 21, 2000, which describes, among other There are about 979 airplanes of the November 21, 2000, as the applicable actions, procedures for inspecting the affected design in the worldwide fleet. sources of service information. Boeing elevator bellcranks for any shear rivets The following table provides the Alert Service Bulletins 767–27A0168 that are broken or yielded. estimated costs for U.S. operators to and 767–27A0169 are referred to in this Accomplishing the actions specified comply with this proposed AD. No parts proposed AD as sources of service in the service information is intended to are necessary to accomplish any action.

ESTIMATED COSTS

Number of Action Work hours Average labor Cost per airplane U.S.-registered Fleet cost rate per hour airplanes

Freeplay measurement ...... 30 $80 $2,400, per measurement 423 $1,015,200, per measure- cycle. ment cycle.

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ESTIMATED COSTS—Continued

Number of Action Work hours Average labor Cost per airplane U.S.-registered Fleet cost rate per hour airplanes

Lubrication ...... 27 $80 $2,160, per lubrication cycle 423 $913,680, per lubrication cycle.

Authority for This Rulemaking The Proposed Amendment 767–27–0198, Revision 1, dated July 19, 2007. Title 49 of the United States Code Accordingly, under the authority specifies the FAA’s authority to issue delegated to me by the Administrator, Repetitive Measurements rules on aviation safety. Subtitle I, the FAA proposes to amend 14 CFR part (g) At the latest of the compliance times Section 106, describes the authority of 39 as follows: specified in paragraphs (g)(1), (g)(2), and the FAA Administrator. Subtitle VII, (g)(3) of this AD, as applicable: Measure the Aviation Programs, describes in more PART 39—AIRWORTHINESS rudder and elevator freeplay. Repeat the DIRECTIVES measurement thereafter at intervals not to detail the scope of the Agency’s exceed 12,000 flight hours or 36 months, authority. 1. The authority citation for part 39 whichever occurs first. Do all actions We are issuing this rulemaking under continues to read as follows: required by this paragraph in accordance the authority described in Subtitle VII, with the service bulletin. Part A, Subpart III, Section 44701, Authority: 49 U.S.C. 106(g), 40113, 44701. (1) Within 12 months after the effective date of this AD. ‘‘General requirements.’’ Under that § 39.13 [Amended] section, Congress charges the FAA with (2) Within 36 months since the date of promoting safe flight of civil aircraft in 2. The Federal Aviation issuance of the original standard Administration (FAA) amends § 39.13 airworthiness certificate or the date of air commerce by prescribing regulations issuance of the original export certificate of for practices, methods, and procedures by removing amendment 39–14616 (71 FR 30272, May 26, 2006) and adding the airworthiness. the Administrator finds necessary for (3) For the elevator freeplay measurement: safety in air commerce. This regulation following new airworthiness directive Within 12,000 flight hours or within 36 is within the scope of that authority (AD): months after the last elevator freeplay because it addresses an unsafe condition Boeing: Docket No. FAA–2007–29259; inspection accomplished in accordance with that is likely to exist or develop on Directorate Identifier 2007–NM–195–AD. Boeing Special Attention Service Bulletin products identified in this rulemaking 767–27–0197 or 767–27–0198, both dated Comments Due Date October 27, 2005, as applicable, whichever action. (a) The FAA must receive comments on occurs first. Regulatory Findings this AD action by October 22, 2007. Related Investigative and Corrective Actions We have determined that this Affected ADs (h) If any measurement found during the proposed AD would not have federalism (b) This AD supersedes AD 2006–11–12. measurement required by paragraph (g) of this AD exceeds any applicable limit implications under Executive Order Applicability 13132. This proposed AD would not specified in the service bulletin: Before further flight, do the applicable related have a substantial direct effect on the (c) This AD applies to all Boeing Model 767–200, –300, –300F, and –400ER series investigative and corrective actions in States, on the relationship between the airplanes, certificated in any category. accordance with the service bulletin. national Government and the States, or on the distribution of power and Unsafe Condition Initial Lubrication responsibilities among the various (d) This AD results from reports of (i) At the latest of the compliance times levels of government. freeplay-induced vibration of the rudder and specified in paragraphs (i)(1), (i)(2), and (i)(3) For the reasons discussed above, I the elevator. The potential for vibration of the of this AD, as applicable: Lubricate the rudder and elevator components specified in certify that the proposed regulation: control surface should be avoided because the point of transition from vibration to the service bulletin. Do all actions required 1. Is not a ‘‘significant regulatory divergent flutter is unknown. We are issuing by this paragraph in accordance with the action’’ under Executive Order 12866; this AD to prevent excessive vibration of the service bulletin. 2. Is not a ‘‘significant rule’’ under the airframe during flight, which could result in (1) Within 9 months after the effective date DOT Regulatory Policies and Procedures loss of control of the airplane. of this AD, or within 9 months since the date (44 FR 11034, February 26, 1979); and of issuance of the original standard Compliance 3. Will not have a significant airworthiness certificate or the date of issuance of the original export certificate of economic impact, positive or negative, (e) You are responsible for having the actions required by this AD performed within airworthiness; whichever occurs later. on a substantial number of small entities the compliance times specified, unless the (2) For airplanes on which BMS 3–33 under the criteria of the Regulatory actions have already been done. grease is not already in use prior to the time Flexibility Act. the lubrication task is being accomplished: We prepared a regulatory evaluation Service Bulletin References Within 3,000 flight hours or 9 months after of the estimated costs to comply with (f) The term ‘‘service bulletin,’’ as used in the last lubrication accomplished in this proposed AD and placed it in the this AD, means the Accomplishment accordance with the service bulletin or AD docket. See the ADDRESSES section Instructions and Appendices A, B, and C of Boeing Special Attention Service Bulletin for a location to examine the regulatory the following service bulletins, as applicable: 767–27–0197 or 767–27–0198, both dated (1) For Model 767–200, –300, and –300F October 27, 2005, whichever occurs first. evaluation. series airplanes: Boeing Special Attention (3) For airplanes on which BMS 3–33 List of Subjects in 14 CFR Part 39 Service Bulletin 767–27–0197, Revision 1, grease is already in use prior to the time the dated July 19, 2007; and lubrication task is being accomplished: Air transportation, Aircraft, Aviation (2) For Model 767–400ER series airplanes: Within 6,000 flight hours or 18 months after safety, Safety. Boeing Special Attention Service Bulletin the last lubrication accomplished in

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accordance with the service bulletin or Issued in Renton, Washington, on Washington, DC, between 9 a.m. and 5 Boeing Special Attention Service Bulletin September 13, 2007. p.m., Monday through Friday, except 767–27–0197 or 767–27–0198, both dated Ali Bahrami, Federal holidays. October 27, 2005, whichever occurs first. Manager, Transport Airplane Directorate, Contact Bombardier, Inc., Canadair, Repetitive Lubrication Aircraft Certification Service. Aerospace Group, P.O. Box 6087, [FR Doc. E7–18544 Filed 9–19–07; 8:45 am] Station Centre-ville, Montreal, Quebec (j) Repeat the lubrication required in BILLING CODE 4910–13–P H3C 3G9, Canada, for service paragraph (i) of this AD at the applicable information identified in this proposed interval specified in paragraph (j)(1) or (j)(2) AD. of this AD. DEPARTMENT OF TRANSPORTATION (1) For airplanes on which BMS 3–33 FOR FURTHER INFORMATION CONTACT: Pong K. Lee, Aerospace Engineer, grease is not already in use prior to the time Federal Aviation Administration the lubrication task is being accomplished: Airframe and Propulsion Branch, ANE– 171, FAA, New York Aircraft At intervals not to exceed 3,000 flight hours 14 CFR Part 39 or 9 months, whichever occurs first. Certification Office, 1600 Stewart (2) For airplanes on which BMS 3–33 [Docket No. FAA–2007–29257; Directorate Avenue, Suite 410, Westbury, New York grease is already in use prior to the time the Identifier 2007–NM–144–AD] 11590; telephone (516) 228–7324; fax lubrication task is being accomplished: At (516) 794–5531. RIN 2120–AA64 intervals not to exceed 6,000 flight hours or SUPPLEMENTARY INFORMATION: 18 months, whichever occurs first. Airworthiness Directives; Bombardier Comments Invited Repetitive Prior or Concurrent Inspection Model CL–600–2B19 (Regional Jet Series 100 & 440) Airplanes We invite you to submit any relevant (k) For airplanes specified in paragraphs written data, views, or arguments (k)(1) and (k)(2) of this AD: Prior to or AGENCY: Federal Aviation regarding this proposed AD. Send your concurrently with the accomplishment of Administration (FAA), Department of comments to an address listed in the each elevator freeplay measurement specified Transportation (DOT). ADDRESSES section. Include the docket in paragraph (g) of this AD, do all applicable ACTION: number ‘‘FAA–2007–29257; Directorate actions required by AD 2001–04–09. Notice of proposed rulemaking (NPRM). Identifier 2007–NM–144–AD’’ at the (1) Group 1, configuration 2, airplanes as beginning of your comments. We identified in Boeing Special Attention SUMMARY: The FAA proposes to adopt a specifically invite comments on the Service Bulletin 767–27–0197, Revision 1, new airworthiness directive (AD) for overall regulatory, economic, dated July 19, 2007. certain Bombardier Model CL–600– environmental, and energy aspects of (2) Group 1, configuration 1, airplanes as 2B19 (Regional Jet Series 100 & 440) the proposed AD. We will consider all identified in Boeing Special Attention airplanes. This proposed AD would comments received by the closing date Service Bulletin 767–27–0198, Revision 1, and may amend the proposed AD in dated July 19, 2007. require repetitive detailed inspections for cracking of the left side and right light of those comments. Alternative Methods of Compliance side frame and reinforcement angles at We will post all comments we (AMOCs) fuselage station (FS) 640 between receive, without change, to http:// (l)(1) The Manager, Seattle Aircraft stringer 9 and stringer 12, and corrective dms.dot.gov, including any personal Certification Office (ACO), FAA, has the actions if necessary. This proposed AD information you provide. We will also authority to approve AMOCs for this AD, if results from reports that cracks have post a report summarizing each requested in accordance with the procedures been discovered on the frame and substantive verbal contact with FAA found in 14 CFR 39.19. reinforcement angles at FS 640. We are personnel concerning this proposed AD. (2) To request a different method of proposing this AD to detect and correct Using the search function of that Web compliance or a different compliance time cracking of the frame, which could lead site, anyone can find and read the for this AD, follow the procedures in 14 CFR to failure of the fuselage structure and comments in any of our dockets, 39.19. Before using any approved AMOC on possible loss of the airplane. including the name of the individual any airplane to which the AMOC applies, who sent the comment (or signed the DATES: We must receive comments on notify your appropriate principal inspector comment on behalf of an association, this proposed AD by October 22, 2007. (PI) in the FAA Flight Standards District business, labor union, etc.). You may Office (FSDO), or lacking a PI, your local ADDRESSES: Use one of the following review the DOT’s complete Privacy Act FSDO. addresses to submit comments on this Statement in the Federal Register (3) An AMOC that provides an acceptable proposed AD. published on April 11, 2000 (65 FR • level of safety may be used for any repair DOT Docket Web site: Go to 19477–78), or you may visit http:// required by this AD, if it is approved by an http://dms.dot.gov and follow the dms.dot.gov. Authorized Representative for the Boeing instructions for sending your comments Commercial Airplanes Delegation Option electronically. Examining the Docket Authorization Organization who has been • Government-wide rulemaking Web You may examine the AD docket on authorized by the Manager, Seattle ACO, to site: Go to http://www.regulations.gov the Internet at http://dms.dot.gov, or in make those findings. For a repair method to and follow the instructions for sending person at the Docket Operations office be approved, the repair must meet the your comments electronically. between 9 a.m. and 5 p.m., Monday certification basis of the airplane, and the • approval must specifically refer to this AD. Mail: U.S. Department of through Friday, except Federal holidays. (4) AMOCs approved previously in Transportation, Docket Operations, M– The Docket Operations office (telephone accordance with AD 2006–11–12 are 30, West Building Ground Floor, Room (800) 647–5527) is located on the approved as AMOCs for the corresponding W12–140, 1200 New Jersey Avenue, SE., ground level of the West Building at the provisions of this AD. Washington, DC 20590. DOT street address stated in the (5) AMOCs approved previously in • Fax: (202) 493–2251. ADDRESSES section. Comments will be accordance with AD 2001–04–09, are • Hand Delivery: Room W12–140 on available in the AD docket shortly after approved as AMOCs for the corresponding the ground floor of the West Building, the Docket Management System receives provisions of paragraph (k) of this AD. 1200 New Jersey Avenue, SE., them.

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Discussion certificated for operation in the United Costs of Compliance Transport Canada Civil Aviation States. This proposed AD would affect about (TCCA), which is the airworthiness Therefore, we are proposing this AD, 739 airplanes of U.S. registry. The authority for Canada, notified us that an which would require accomplishing the proposed inspection would take about 2 unsafe condition may exist on certain actions specified in the service work hours per airplane, at an average Bombardier Model CL–600–2B19 information described previously, labor rate of $80 per work hour. Based (Regional Jet Series 100 & 440) except as discussed under ‘‘Differences on these figures, the estimated cost of airplanes. TCCA advises that cracks Between the Proposed AD and the proposed AD for U.S. operators is have been discovered on the frame and Bombardier Alert Service Bulletin/ $118,240, or $160 per airplane, per reinforcement angles at fuselage station Canadian Airworthiness Directive.’’ inspection cycle. (FS) 640 on a number of CRJ (Canadair Differences Between the Proposed AD Authority for This Rulemaking Regional Jet) airplanes. This condition, and Bombardier Alert Service Bulletin/ Title 49 of the United States Code if not corrected, could result in failure Canadian Airworthiness Directive of the fuselage structure and possible specifies the FAA’s authority to issue loss of the airplane. The Canadian airworthiness directive rules on aviation safety. Subtitle I, specifies that Bombardier Alert Service Section 106, describes the authority of Relevant Service Information Bulletin 601R–53–061, Revision B, the FAA Administrator. Subtitle VII, Bombardier has issued Alert Service dated February 20, 2003, or later Aviation Programs, describes in more Bulletin 601R–53–061, Revision E, revisions, must be used to do all detail the scope of the Agency’s dated December 7, 2006. The alert described inspections and actions. authority. service bulletin describes procedures for However, we have determined that We are issuing this rulemaking under doing repetitive detailed visual Revision E, dated December 7, 2006, of the authority described in Subtitle VII, inspections for cracking of the frame at the alert service bulletin no longer Part A, Subpart III, Section 44701, fuselage station (FS) 640 between contains certain actions described by ‘‘General requirements.’’ Under that stringer 9 and stringer 12 (Part A of the Revision B. Therefore, this proposed AD section, Congress charges the FAA with Accomplishment Instructions) and, if would require doing all actions in promoting safe flight of civil aircraft in necessary, corrective actions as follows: accordance with Alert Service Bulletin air commerce by prescribing regulations • Repair as described in Part A of the 601R–53–061, Revision E, dated for practices, methods, and procedures Accomplishment Instructions; December 7, 2006. This difference has the Administrator finds necessary for • Install a modification, including been coordinated with TCCA. safety in air commerce. This regulation related investigative and corrective is within the scope of that authority In this proposed AD, the ‘‘detailed because it addresses an unsafe condition actions; or visual inspection’’ specified in the • Contact Bombardier for repair that is likely to exist or develop on Bombardier alert service bulletin and instructions. products identified in this rulemaking Canadian airworthiness directive is action. The related investigative and corrective referred to as a ‘‘detailed inspection.’’ actions of the modification (Part C of the We have included the definition for a Regulatory Findings Accomplishment Instructions) include detailed inspection in a note in the We have determined that this cutting out a section of the flange frame proposed AD. proposed AD would not have federalism at FS640 then doing a liquid penetrant The Bombardier alert service bulletin implications under Executive Order or eddy current inspection for cracking and Canadian airworthiness directive 13132. This proposed AD would not of the skin doubler, and contacting specify to contact Bombardier for have a substantial direct effect on the Bombardier for repair instructions. instructions on how to repair certain States, on the relationship between the Accomplishing the actions specified in conditions, but this proposed AD would national Government and the States, or the service information is intended to require repairing those conditions using on the distribution of power and adequately address the unsafe a method approved by the FAA or responsibilities among the various condition. TCCA mandated the service TCCA (or its delegated agent). In light of levels of government. information and issued Canadian the type of repair that would be required For the reasons discussed above, I airworthiness directive CF–2003–12, to address the unsafe condition, and certify that the proposed regulation: dated May 7, 2003, to ensure the consistent with existing bilateral 1. Is not a ‘‘significant regulatory continued airworthiness of these airworthiness agreements, we have action’’ under Executive Order 12866; airplanes in Canada. determined that, for this proposed AD, 2. Is not a ‘‘significant rule’’ under the FAA’s Determination and Requirements a repair approved by the FAA or TCCA DOT Regulatory Policies and Procedures of the Proposed AD (or its delegated agent) would be (44 FR 11034, February 26, 1979); and 3. Will not have a significant These airplanes are manufactured in acceptable for compliance with this proposed AD. economic impact, positive or negative, Canada and are type certificated for on a substantial number of small entities operation in the United States under the Although the Accomplishment under the criteria of the Regulatory provisions of section 21.29 of the Instructions of the alert service bulletin Flexibility Act. Federal Aviation Regulations (14 CFR describe procedures for submitting We prepared a regulatory evaluation 21.29) and the applicable bilateral certain information to the manufacturer, of the estimated costs to comply with airworthiness agreement. Pursuant to this proposed AD would not require that this proposed AD and placed it in the this bilateral airworthiness agreement, action. AD docket. See the ADDRESSES section TCCA has kept the FAA informed of the Interim Action for a location to examine the regulatory situation described above. We have evaluation. examined TCCA’s findings, evaluated We consider this proposed AD all pertinent information, and interim action. If final action is later List of Subjects in 14 CFR Part 39 determined that we need to issue an AD identified, we might consider further Air transportation, Aircraft, Aviation for airplanes of this type design that are rulemaking then. safety, Safety.

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The Proposed Amendment examination of a specific item, installation, Office (FSDO), or lacking a PI, your local or assembly to detect damage, failure, or FSDO. Accordingly, under the authority irregularity. Available lighting is normally delegated to me by the Administrator, supplemented with a direct source of good Related Information the FAA proposes to amend 14 CFR part lighting at an intensity deemed appropriate. (m) Canadian airworthiness directive CF– 39 as follows: Inspection aids such as mirror, magnifying 2003–12, dated May 7, 2003, also addresses lenses, etc., may be necessary. Surface the subject of this AD. PART 39—AIRWORTHINESS cleaning and elaborate procedures may be Issued in Renton, Washington, on DIRECTIVES required.’’ September 12, 2007. 1. The authority citation for part 39 Repetitive Inspection and Corrective Action Ali Bahrami, continues to read as follows: (h) If no crack is found during the Manager, Transport Airplane Directorate, Aircraft Certification Service. Authority: 49 U.S.C. 106(g), 40113, 44701. inspection required by paragraph (g) of this AD: Repeat the detailed inspection thereafter [FR Doc. E7–18539 Filed 9–19–07; 8:45 am] § 39.13 [Amended] at intervals not to exceed 1,100 flight cycles, BILLING CODE 4910–13–P 2. The Federal Aviation until the frame modification described in paragraph (i)(2) of this AD has been done. Administration (FAA) amends § 39.13 (i) If any crack is found during the DEPARTMENT OF TRANSPORTATION by adding the following new inspection required by paragraph (g) of this airworthiness directive (AD): AD: Before further flight, repair the crack in Federal Aviation Administration Bombardier, Inc. (Formerly Canadair): accordance with paragraph (i)(1), (i)(2), or Docket No. FAA–2007–29257; (i)(3) of this AD, as applicable. 14 CFR Part 39 Directorate Identifier 2007–NM–144–AD. (1) For any crack found in the frame at the stringer 9 cut-out only, repair in accordance [Docket No. FAA–2007–29255; Directorate Comments Due Date with Part A of the Accomplishment Identifier 2007–NM–085–AD] (a) The FAA must receive comments on Instructions of the service bulletin. this AD action by November 5, 2007. (2) For any crack found in the frame RIN 2120–AA64 reinforcement doubler only: Do the frame Affected ADs modification (including related investigative Airworthiness Directives; Boeing (b) None. and corrective actions) described in Part C of Model 737–100, –200, –200C, –300, the Accomplishment Instructions of the –400, and –500 Series Airplanes Applicability service bulletin, except where the alert (c) This AD applies to Bombardier Model service bulletin specifies to contact the AGENCY: Federal Aviation CL–600–2B19 (Regional Jet Series 100 & 440) manufacturer for repair instructions, repair Administration (FAA), Department of airplanes, certificated in any category; as the crack using a method approved by either Transportation (DOT). identified in Bombardier Alert Service the Manager, New York Aircraft Certification Bulletin 601R–53–061, Revision E, dated Office (ACO), FAA; or Transport Canada ACTION: Notice of proposed rulemaking December 7, 2006. Civil Aviation (TCCA) (or its delegated (NPRM). Unsafe Condition agent); then do the detailed inspection required by paragraph (j) of this AD. SUMMARY: The FAA proposes to adopt a (d) This AD results from reports that cracks (3) For any crack found in areas of the new airworthiness directive (AD) for have been discovered on the frame and inspection zone described in paragraph (g) of certain Boeing Model 737–100, –200, reinforcement angles at fuselage station (FS) this AD other than those described in –200C, –300, –400, and –500 series 640. Failure of this frame could degrade the paragraphs (i)(1) and (i)(2) of this AD: Repair airplanes. This proposed AD would structural integrity of the airplane. We are the crack using a method approved by either require doing repetitive internal eddy issuing this AD to detect and correct cracking the Manager, New York ACO, FAA; or TCCA current and detailed inspections to of the frame, which could lead to failure of (or its delegated agent). the fuselage structure and possible loss of the detect cracked stringer tie clips; doing airplane. Repetitive Inspection After Frame applicable corrective and related Modification investigative actions, if necessary; and Compliance (j) Within 12,000 flight cycles after doing measuring the fastener spacing and the (e) You are responsible for having the the modification described in paragraph (i)(2) edge margin; as applicable. As a actions required by this AD performed within of this AD, do the detailed inspection temporary alternative to doing the the compliance times specified, unless the required by paragraph (g) of this AD. Repeat actions described previously, this actions have already been done. the detailed inspection thereafter at intervals proposed AD would require repetitive Service Bulletin Reference not to exceed 1,100 flight cycles. external general visual inspections of (f) The term ‘‘service bulletin,’’ as used in No Reporting Requirement the skin and lap joints for cracks and this AD, means the Accomplishment (k) Although the alert service bulletin evidence of overload resulting from Instructions of Bombardier Alert Service referred to in this AD specifies to submit cracked stringer tie clips, and applicable Bulletin 601R–53–061, Revision E, dated certain information to the manufacturer, this corrective actions if necessary. This December 7, 2006. AD does not include that requirement. proposed AD results from a report of Detailed Inspection Alternative Methods of Compliance several cracked stringer tie clips. We are (g) Before the accumulation of 8,600 total (AMOCs) proposing this AD to prevent multiple flight cycles or within 1,100 flight cycles (l)(1) The Manager, New York ACO, FAA, cracked stringer tie clips and damaged after the effective date of this AD, whichever has the authority to approve AMOCs for this skin and frames, which could lead to occurs later: Perform a detailed inspection to AD, if requested in accordance with the the skin and frame structure developing detect cracking of the left side and right side procedures found in 14 CFR 39.19. cracks and consequent decompression frames and reinforcement angles at FS640 (2) To request a different method of of the airplane. between stringer 9 and stringer 12, in compliance or a different compliance time DATES: accordance with Part A of the We must receive comments on for this AD, follow the procedures in 14 CFR this proposed AD by November 5, 2007. Accomplishment Instructions of the service 39.19. Before using any approved AMOC on bulletin. any airplane to which the AMOC applies, ADDRESSES: Use one of the following Note 1: For the purposes of this AD, a notify your appropriate principal inspector addresses to submit comments on this detailed inspection is: ‘‘An intensive (PI) in the FAA Flight Standards District proposed AD.

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• DOT Docket Web site: Go to Examining the Docket April 12, 2002), applicable to certain http://dms.dot.gov and follow the You may examine the AD docket on Boeing Model 737–200, –200C, –300, instructions for sending your comments the Internet at http://dms.dot.gov, or in –400, and –500 series airplanes. That electronically. AD requires repetitive inspections to • person at the Docket Operations office Government-wide rulemaking web between 9 a.m. and 5 p.m., Monday find cracking of the lower skin at the site: Go to http://www.regulations.gov through Friday, except Federal holidays. lower row of fasteners in the lap joints and follow the instructions for sending The Docket Operations office (telephone of the fuselage, and repair of cracking your comments electronically. (800) 647–5527) is located on the found. That AD also requires • Mail: U.S. Department of ground level of the West Building at the modification of the fuselage lap joints at Transportation, Docket Operations, M– DOT street address stated in the certain locations, which constitutes 30, West Building Ground Floor, Room ADDRESSES section. Comments will be terminating action for certain repetitive W12–140, 1200 New Jersey Avenue, SE., available in the AD docket shortly after inspections. Washington, DC 20590. This proposed AD would not affect • Fax: (202) 493–2251. the Docket Management System receives • Hand Delivery: Room W12–140 on them. the current requirements of AD 2002– 07–08. the ground floor of the West Building, Discussion 1200 New Jersey Avenue, SE., We have received a report of 15 Relevant Service Information Washington, DC, between 9 a.m. and 5 cracked stringer tie clips in the crown p.m., Monday through Friday, except We have reviewed Boeing Special skin area between station (STA) 500B Attention Service Bulletin 737–53– Federal holidays. and STA 907 between stringer (S) 10L Contact Boeing Commercial 1268, dated August 25, 2006. This and S–10R, on a Boeing Model 737 Airplanes, P.O. Box 3707, Seattle, service bulletin supersedes Boeing airplane. The airplane had accumulated Washington 98124–2207, for the service Service Bulletin 737–53–1085, Revision total 31,415 flight cycles. This airplane information identified in this proposed 1. had three adjacent cracked clips at two AD. The service bulletin describes one consecutive body station frames (six FOR FURTHER INFORMATION CONTACT: clips total). The six stringer tie clips required inspection and one temporary Wayne Lockett, Aerospace Engineer, were cracked along the joint common to alternative inspection. Inspection A, the Airframe Branch, ANM–120S, FAA, the stringer. The six total stringer tie one required inspection, involves the Seattle Aircraft Certification Office, clips were the same formed bonded following: 1601 Lind Avenue, SW., Renton, stringer tie clips that were installed as • Doing repetitive internal eddy Washington 98057–3356; telephone terminating action in accordance with current and detailed inspections to (425) 917–6447; fax (425) 917–6590. Boeing Service Bulletin 737–53–1085, detect cracked stringer tie clips. The SUPPLEMENTARY INFORMATION: Revision 1, dated May 10, 1990. inspection area is from STA 559 to STA Comments Invited Stringer tie clip cracking along the 887, STA 360 to STA 540, and STA 907. joint common to the stringer occurs The inspections from STA 559 to STA We invite you to submit any relevant primarily as a result of cyclic loading 887 are identical to those specified in written data, views, or arguments associated with cabin pressure and Boeing Service Bulletin 737–53–1085, regarding this proposed AD. Send your flight loads. If three adjacent stringer tie Revision 1. If the terminating action was comments to an address listed in the clips on one frame crack, it could result done in accordance with Boeing Service ADDRESSES section. Include the docket in an inability of the fuselage frame Bulletin 737–53–1085, the inspections number ‘‘FAA–2007–29255; Directorate structure to support operating loads. need to be restarted in accordance with Identifier 2007–NM–085–AD’’ at the This could result in local skin buckling Boeing Special Attention Service beginning of your comments. We and deformation of the skin and frame. Bulletin 737–53–1268. specifically invite comments on the Multiple cracked stringer tie clips and • Doing applicable corrective and overall regulatory, economic, damaged skin and frames, if not related investigative actions, if environmental, and energy aspects of corrected, could lead to the skin and necessary. The corrective actions the proposed AD. We will consider all frame structure developing cracks, comments received by the closing date include replacing any cracked stringer which could result in decompression of tie clip with a new clip, contacting and may amend the proposed AD in the airplane. light of those comments. Boeing for repair instructions, and We will post all comments we Other Relevant Rulemaking repairing any damaged lap joints; as receive, without change, to http:// applicable. The related investigative We previously issued AD 93–08–04, actions include doing an internal dms.dot.gov, including any personal amendment 39–8551 (58 FR 25546, information you provide. We will also detailed inspection to detect damaged or April 27, 1993), for certain Boeing deformed skin and frame and to detect post a report summarizing each Model 737–100, –200, and –200C series damaged lap joints, and doing internal substantive verbal contact with FAA airplanes. That AD requires structural eddy current inspections to detect personnel concerning this proposed AD. inspections of older airplanes and is Using the search function of that web cracked lap joints; as applicable. part of the Aging Airplane Service • site, anyone can find and read the Bulletin Structural Modification and Measuring the fastener spacing and comments in any of our dockets, Inspection Program. Boeing Service the edge margin; as applicable. including the name of the individual Bulletin 737–53–1085, Revision 1, is The initial compliance time for who sent the comment (or signed the one of several service bulletins required Inspection A is before the accumulation comment on behalf of an association, by that AD. of 25,000 or 35,000 total flight cycles (as business, labor union, etc.). You may This proposed AD would affect the applicable), or within 2 or 3 years (as review DOT’s complete Privacy Act requirements of AD 93–08–04 applicable) after the date of the service Statement in the Federal Register pertaining to Boeing Service Bulletin bulletin, whichever occurs later. The published on April 11, 2000 (65 FR 737–53–1085, Revision 1. repeat interval for Inspection A is 19477–78), or you may visit http:// We previously issued AD 2002–07– 15,000 or 20,000 flight cycles (as dms.dot.gov. 08, amendment 39–12702 (67 FR 17917, applicable).

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Inspection B, which is a temporary clip with a new clip. The optional the service information described alternative to doing Inspection A, inspection can be done in addition to previously, except as discussed under involves the following: and at the same time as Inspection A ‘‘Differences Between the Proposed AD • Doing repetitive external general described previously. The optional and Service Information.’’ visual inspections of the skin and lap inspection will detect damaged stringer Differences Between the Proposed AD joints for cracks and evidence of clips earlier than the detailed and Service Information overload resulting from cracked stringer inspection, which may prevent future tie clips, and costly repairs. The service information specifies to • Doing applicable corrective actions Accomplishing the actions specified contact the manufacturer for if necessary. The corrective actions in the service information is intended to instructions on how to repair certain include contacting Boeing for repair adequately address the unsafe conditions, but this proposed AD would instructions, and repairing any cracked condition. require repairing those conditions in or damaged lap joint and skin. The service bulletin refers to Boeing one of the following ways: For Inspection B, the threshold for the Service Bulletin 737–53A1177, Revision • Using a method that we approve; or initial compliance times ranges between 6, dated May 31, 2001, as an additional • Using data that meet the 37,500 and 47,500 total flight cycles, source of service information for doing certification basis of the airplane, and and the grace period for the initial an internal eddy current inspection of that have been approved by an compliance times is 25,000 flight cycles the lap joint for certain airplane Authorized Representative for the or 6 or 12 months, depending on the configurations. Boeing Commercial Airplanes number of flight cycles on the airplane. Delegation Option Authorization FAA’s Determination and Requirements Inspection B must be done before Organization whom we have authorized of the Proposed AD exceeding an inspection period ranging to make those findings. from 5,000 to 50,000 total flight cycles. We have evaluated all pertinent The repeat interval for Inspection B is information and identified an unsafe Costs of Compliance 2,500 flight cycles. condition that is likely to exist or There are about 2,685 airplanes of the The service bulletin also describes develop on other airplanes of this same affected design in the worldwide fleet. procedures for an optional eddy current type design. For this reason, we are The following table provides the inspection to detect damaged stringer tie proposing this AD, which would require estimated costs for U.S. operators to clips and replacement of any cracked accomplishing the actions specified in comply with this proposed AD.

ESTIMATED COSTS

Average labor Number of Action Work hours 1 Cost per airplane 1 U.S.-registered Fleet cost 1 rate per hour airplanes

Inspection A ...... Between 40 and 103 ...... $80 Between $3,200 and 787 Between $2,518,400 and $8,240, per inspection $6,484,880, per in- cycle. spection cycle. Inspection B (temporary Between 2 and 109 ...... 80 Between $160 and 787 Between $125,920 and alternative to Inspection $8,720. $6,862,640, per in- A). spection cycle. 1 Depending on the airplane configuration.

Authority for This Rulemaking Regulatory Findings We prepared a regulatory evaluation Title 49 of the United States Code of the estimated costs to comply with We have determined that this this proposed AD and placed it in the specifies the FAA’s authority to issue proposed AD would not have federalism AD docket. See the ADDRESSES section rules on aviation safety. Subtitle I, implications under Executive Order for a location to examine the regulatory Section 106, describes the authority of 13132. This proposed AD would not the FAA Administrator. Subtitle VII, have a substantial direct effect on the evaluation. Aviation Programs, describes in more States, on the relationship between the List of Subjects in 14 CFR Part 39 detail the scope of the Agency’s national Government and the States, or authority. on the distribution of power and Air transportation, Aircraft, Aviation We are issuing this rulemaking under responsibilities among the various safety, Safety. the authority described in Subtitle VII, levels of government. The Proposed Amendment Part A, Subpart III, Section 44701, For the reasons discussed above, I ‘‘General requirements.’’ Under that certify that the proposed regulation: Accordingly, under the authority section, Congress charges the FAA with delegated to me by the Administrator, promoting safe flight of civil aircraft in 1. Is not a ‘‘significant regulatory action’’ under Executive Order 12866; the FAA proposes to amend 14 CFR part air commerce by prescribing regulations 39 as follows: for practices, methods, and procedures 2. Is not a ‘‘significant rule’’ under the DOT Regulatory Policies and Procedures the Administrator finds necessary for PART 39—AIRWORTHINESS (44 FR 11034, February 26, 1979); and safety in air commerce. This regulation DIRECTIVES is within the scope of that authority 3. Will not have a significant because it addresses an unsafe condition economic impact, positive or negative, 1. The authority citation for part 39 that is likely to exist or develop on on a substantial number of small entities continues to read as follows: products identified in this rulemaking under the criteria of the Regulatory action. Flexibility Act. Authority: 49 U.S.C. 106(g), 40113, 44701.

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§ 39.13 [Amended] cracks and evidence of overload resulting bulletins. Operators are required to continue 2. The Federal Aviation from cracked stringer tie clips, and to inspect and/or modify per the other Administration (FAA) amends § 39.13 applicable corrective actions if necessary. Do service bulletins listed in that AD. by adding the following new all applicable actions at the applicable compliance times and repeat intervals Alternative Methods of Compliance airworthiness directive (AD): identified in tables 9 through 12 inclusive of (AMOCs) Boeing: Docket No. FAA–2007–29255; paragraph 1.E., ‘‘Compliance,’’ of the service (o)(1) The Manager, Seattle Aircraft Directorate Identifier 2007–NM–085–AD. bulletin, but not to exceed the flight cycles Certification Office (ACO), FAA, has the in the ‘‘Inspection Period Allowed’’ column authority to approve AMOCs for this AD, if Comments Due Date of the tables; except as provided by requested in accordance with the procedures (a) The FAA must receive comments on paragraphs (i) and (l) of this AD. Do all found in 14 CFR 39.19. this AD action by November 5, 2007. applicable actions in accordance with the (2) To request a different method of Accomplishment Instructions of the service Affected ADs compliance or a different compliance time bulletin, except as provided by paragraph (m) for this AD, follow the procedures in 14 CFR (b) AD 93–08–04, amendment 39–8551. of this AD. 39.19. Before using any approved AMOC on Applicability Note 2: The eddy current inspection along any airplane to which the AMOC applies, the stringer tie clip radius to detect damage notify your appropriate principal inspector (c) This AD applies to Boeing Model 737– and replacement, as applicable, specified in (PI) in the FAA Flight Standards District 100, –200, –200C, –300, –400, and –500 Office (FSDO), or lacking a PI, your local series airplanes, certificated in any category; paragraph 3.B.5. of the Accomplishment FSDO. as identified in Boeing Service Bulletin 737– Instructions of the service bulletin are not (3) An AMOC that provides an acceptable 53–1268, dated August 25, 2006. required by this AD. The actions are optional and can be done in addition to and at the level of safety may be used for any repair Unsafe Condition same time as the actions required by required by this AD, if it is approved by an (d) This AD results from a report of several paragraph (g) of this AD. Authorized Representative for the Boeing cracked stringer tie clips. We are issuing this Commercial Airplanes Delegation Option Exceptions to Service Information AD to prevent multiple cracked stringer tie Authorization Organization who has been clips and damaged skin and frames, which (i) Where the service bulletin specifies a authorized by the Manager, Seattle ACO, to could lead to the skin and frame structure compliance time after the date of the service make those findings. For a repair method to developing cracks and consequent bulletin, this AD requires compliance within be approved, the repair must meet the decompression of the airplane. the specified compliance time after the certification basis of the airplane, and the effective date of this AD. approval must specifically refer to this AD. Compliance (j) For Model 737–100, –200, and –200C Issued in Renton, Washington, on (e) You are responsible for having the series airplanes, on which Boeing Service September 12, 2007. actions required by this AD performed within Bulletin 737–53–1085, Revision 1, dated May Ali Bahrami, the compliance times specified, unless the 10, 1990, has not been done in accordance actions have already been done. with AD 93–08–04: As of the effective date Manager, Transport Airplane Directorate, of this AD, do the applicable inspections Aircraft Certification Service. Service Bulletin References from STA 559 to STA 887 in accordance with [FR Doc. E7–18554 Filed 9–19–07; 8:45 am] (f) The term ‘‘the service bulletin,’’ as used paragraph (g) of this AD, at the applicable BILLING CODE 4910–13–P in this AD, means the Accomplishment compliance times specified in paragraph (b) Instructions of Boeing Service Bulletin 737– of AD 93–08–04. 53–1268, dated August 25, 2006. (k) In the first row of tables 5 and 6 of DEPARTMENT OF TRANSPORTATION paragraph 1.E., ‘‘Compliance,’’ of the service Inspection A: Required Internal Inspections, bulletin, where the service bulletin specifies Applicable Corrective and Related Federal Aviation Administration a compliance time of before 25,000 total Investigative Actions, and Measurement airplane flight cycles, this AD requires a (g) Do repetitive internal eddy current and compliance time of before the accumulation 14 CFR Part 39 detailed inspections to detect cracked of 25,000 total flight cycles, or within 2 years [Docket No. FAA–2007–29256; Directorate stringer tie clips; do applicable corrective after the effective date of this AD, whichever Identifier 2007–NM–137–AD] and related investigative actions, if occurs later. necessary; and measure the fastener spacing (l) Where the service bulletin specifies no RIN 2120–AA64 and the edge margin; as applicable. Do all starting point (e.g., ‘‘after the date on the applicable actions at the applicable service bulletin’’) for a grace period, this AD Airworthiness Directives; Fokker compliance times and repeat intervals requires compliance within the specified Model F.28 Mark 0070 and 0100 identified in tables 2 through 8 inclusive of grace period after the effective date of this Airplanes paragraph 1.E., ‘‘Compliance,’’ of the service AD. bulletin; except as provided by paragraphs (m) Where the service bulletin specifies to AGENCY: Federal Aviation (i), (j), and (k) of this AD. Do all applicable contact Boeing for appropriate action: Before Administration (FAA), DOT. actions in accordance with the further flight, repair the discrepancy using a Accomplishment Instructions of the service ACTION: Notice of proposed rulemaking method approved in accordance with the (NPRM). bulletin, except as provided by paragraph (m) procedures specified in paragraph (o) of this of this AD. AD. SUMMARY: Note 1: The service bulletin refers to We propose to adopt a new Boeing Service Bulletin 737–53A1177, Certain Actions End Certain Requirements of airworthiness directive (AD) for the Revision 6, dated May 31, 2001, as an AD 93–08–04 products listed above. This proposed additional source of service information for (n) Accomplishment of the internal eddy AD results from mandatory continuing doing an internal eddy current inspection of current and detailed inspections for STA 559 airworthiness information (MCAI) the lap joint for certain airplane to STA 887 in accordance with paragraph (g) originated by an aviation authority of configurations. of this AD constitutes compliance with the another country to identify and correct inspections required by paragraph (a) of AD Inspection B: Temporary Alternative an unsafe condition on an aviation 93–08–04, as it pertains to Boeing Service product. The MCAI describes the unsafe External Inspections and Corrective Actions Bulletin 737–53–1085, Revision 1, dated May condition as: (h) As a temporary alternative to doing the 10, 1990. Accomplishment of the internal actions required by paragraph (g) of this AD, eddy current and detailed inspections does Two events have been reported of Fokker do repetitive external general visual not terminate the remaining requirements of 100 (F.28 Mk.0100) aircraft, where the Nose inspections of the skin and lap joints for AD 93–08–04, as it applies to other service Landing Gear (NLG) failed to extend in the

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normal mode and problems were 2007–NM–137–AD’’ at the beginning of of the unsafe condition described in the experienced to open the NLG doors, almost your comments. We specifically invite MCAI and service information preventing extension of the NLG in the comments on the overall regulatory, referenced above. We are proposing this emergency (alternate) mode. Subsequent economic, environmental, and energy AD because we evaluated all pertinent investigation and tests have shown that the information and determined an unsafe friction of the bearing in the roller of the NLG aspects of this proposed AD. We will Door Uplock Bracket Assembly is high, consider all comments received by the condition exists and is likely to exist or causing increased resistance in the closing date and may amend this develop on other products of the same mechanical system that unlocks the NLG proposed AD based on those comments. type design. We will post all comments we doors. This condition, if not corrected, may Differences Between This AD and the result in a NLG up landing, which is receive, without change, to http:// MCAI or Service Information considered a hazardous event. dms.dot.gov, including any personal The proposed AD would require information you provide. We will also We have reviewed the MCAI and actions that are intended to address the post a report summarizing each related service information and, in unsafe condition described in the MCAI. substantive verbal contact we receive general, agree with their substance. But we might have found it necessary to use DATES: We must receive comments on about this proposed AD. different words from those in the MCAI this proposed AD by October 22, 2007. Discussion to ensure the AD is clear for U.S. ADDRESSES: You may send comments by The Civil Aviation Authority—The operators and is enforceable. In making any of the following methods: • Netherlands (CAA–NL), which is the these changes, we do not intend to differ DOT Docket Web Site: Go to aviation authority for the Netherlands, substantively from the information http://dms.dot.gov and follow the has issued Dutch Airworthiness provided in the MCAI and related instructions for sending your comments Directive NL–2006–004, dated February service information. electronically. 28, 2006 (referred to after this as ‘‘the We might also have proposed • Fax: (202) 493–2251. MCAI’’), to correct an unsafe condition different actions in this AD from those • Mail: U.S. Department of for the specified products. The MCAI in the MCAI in order to follow FAA Transportation, Docket Operations, M– states: policies. Any such differences are 30, West Building Ground Floor, Room highlighted in a NOTE within the Two events have been reported of Fokker W12–140, 1200 New Jersey Avenue, SE., proposed AD. Washington, DC 20590. 100 (F.28 Mk.0100) aircraft, where the Nose • Hand Delivery: Room W12–140 on Landing Gear (NLG) failed to extend in the Costs of Compliance the ground floor of the West Building, normal mode and problems were experienced to open the NLG doors, almost Based on the service information, we 1200 New Jersey Avenue, SE., preventing extension of the NLG in the estimate that this proposed AD would Washington, DC, between 9 a.m. and 5 emergency (alternate) mode. Subsequent affect about 13 products of U.S. registry. p.m., Monday through Friday, except investigation and tests have shown that the We also estimate that it would take Federal holidays. friction of the bearing in the roller of the NLG about 5 work-hours per product to • Federal eRulemaking Portal: http:// Door Uplock Bracket Assembly is high, comply with the basic requirements of www.regulations.gov. Follow the causing increased resistance in the this proposed AD. The average labor instructions for submitting comments. mechanical system that unlocks the NLG rate is $80 per work-hour. Required doors. This condition, if not corrected, may Examining the AD Docket result in a NLG up landing, which is parts would cost about $135 per considered a hazardous event. Since a product. Where the service information You may examine the AD docket on lists required parts costs that are the Internet at http://dms.dot.gov; or in potentially unsafe condition has been identified that may exist or develop on covered under warranty, we have person at the Docket Operations office aircraft of the same type design, this assumed that there will be no charge for between 9 a.m. and 5 p.m., Monday Airworthiness Directive requires the these costs. As we do not control through Friday, except Federal holidays. introduction of an improved roller in the warranty coverage for affected parties, The AD docket contains this proposed NLG Door Uplock Bracket Assembly. some parties may incur costs higher AD, the regulatory evaluation, any You may obtain further information by than estimated here. Based on these comments received, and other examining the MCAI in the AD docket. figures, we estimate the cost of the information. The street address for the proposed AD on U.S. operators to be Relevant Service Information Docket Operations office (telephone $6,955, or $535 per product. (800) 647–5527) is in the ADDRESSES Fokker Services B.V. has issued section. Comments will be available in Service Bulletin SBF100–32–143, dated Authority for This Rulemaking the AD docket shortly after receipt. February 15, 2006, and Component Title 49 of the United States Code FOR FURTHER INFORMATION CONTACT: Tom Service Bulletin D76501–32–17, dated specifies the FAA’s authority to issue Rodriguez, Aerospace Engineer, February 15, 2006. The actions rules on aviation safety. Subtitle I, International Branch, ANM–116, FAA, described in this service information section 106, describes the authority of Transport Airplane Directorate, 1601 (replacing the roller in the uplock the FAA Administrator. ‘‘Subtitle VII: Lind Avenue, SW., Renton, Washington bracket) are intended to correct the Aviation Programs,’’ describes in more 98057–3356; telephone (425) 227–1137; unsafe condition identified in the detail the scope of the Agency’s fax (425) 227–1149. MCAI. authority. SUPPLEMENTARY INFORMATION: We are issuing this rulemaking under FAA’s Determination and Requirements the authority described in ‘‘Subtitle VII, Comments Invited of This Proposed AD Part A, Subpart III, Section 44701: We invite you to send any written This product has been approved by General requirements.’’ Under that relevant data, views, or arguments about the aviation authority of another section, Congress charges the FAA with this proposed AD. Send your comments country, and is approved for operation promoting safe flight of civil aircraft in to an address listed under the in the United States. Pursuant to our air commerce by prescribing regulations ADDRESSES section. Include ‘‘Docket No. bilateral agreement with the State of for practices, methods, and procedures FAA–2007–29256; Directorate Identifier Design Authority, we have been notified the Administrator finds necessary for

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safety in air commerce. This regulation Subject to assure the product is airworthy before it is within the scope of that authority (d) Air Transport Association (ATA) of is returned to service. because it addresses an unsafe condition America Code 32: Landing gear. (3) Reporting Requirements: For any that is likely to exist or develop on reporting requirement in this AD, under the Reason provisions of the Paperwork Reduction Act, products identified in this rulemaking the Office of Management and Budget (OMB) action. (e) The mandatory continuing airworthiness information (MCAI) states: has approved the information collection Regulatory Findings Two events have been reported of Fokker requirements and has assigned OMB Control 100 (F.28 Mk.0100) aircraft, where the Nose Number 2120–0056. We determined that this proposed AD Landing Gear (NLG) failed to extend in the Related Information would not have federalism implications normal mode and problems were (h) Refer to MCAI Dutch Airworthiness under Executive Order 13132. This experienced to open the NLG doors, almost proposed AD would not have a preventing extension of the NLG in the Directive NL–2006–004, dated February 28, substantial direct effect on the States, on emergency (alternate) mode. Subsequent 2006, Fokker Service Bulletin SBF100–32– 143, dated February 15, 2006, and Fokker the relationship between the national investigation and tests have shown that the friction of the bearing in the roller of the NLG Component Service Bulletin D76501–32–17, Government and the States, or on the dated February 15, 2006, for related distribution of power and Door Uplock Bracket Assembly is high, causing increased resistance in the information. responsibilities among the various mechanical system that unlocks the NLG Issued in Renton, Washington, on levels of government. doors. This condition, if not corrected, may September 12, 2007. For the reasons discussed above, I result in a NLG up landing, which is Ali Bahrami, certify this proposed regulation: considered a hazardous event. Since a potentially unsafe condition has been Manager, Transport Airplane Directorate, 1. Is not a ‘‘significant regulatory Aircraft Certification Service. action’’ under Executive Order 12866; identified that may exist or develop on [FR Doc. E7–18553 Filed 9–19–07; 8:45 am] 2. Is not a ‘‘significant rule’’ under the aircraft of the same type design, this Airworthiness Directive requires the BILLING CODE 4910–13–P DOT Regulatory Policies and Procedures introduction of an improved roller in the (44 FR 11034, February 26, 1979); and NLG Door Uplock Bracket Assembly. 3. Will not have a significant economic impact, positive or negative, Actions and Compliance DEPARTMENT OF HEALTH AND on a substantial number of small entities (f) Unless already done, do the following HUMAN SERVICES actions. under the criteria of the Regulatory Food and Drug Administration Flexibility Act. (1) Within 4,000 flight hours after the effective date of this AD, modify the NLG We prepared a regulatory evaluation Door Uplock Bracket Assembly, in 21 CFR Part 2 of the estimated costs to comply with accordance with the Accomplishment this proposed AD and placed it in the Instructions of Fokker Service Bulletin [Docket No. 2007N–0262] AD docket. SBF100–32–143, dated February 15, 2006. RIN 0910–AF92 (2) As of 18 months after the effective date List of Subjects in 14 CFR Part 39 of this AD, no spare NLG Door Uplock Bracket Assembly may be installed as a Use of Ozone-Depleting Substances; Air transportation, Aircraft, Aviation Removal of Essential-Use Designation safety, Safety. replacement part unless it has been modified in accordance with the Accomplishment (Epinephrine) The Proposed Amendment Instructions of Fokker Component Service Bulletin D76501–32–17, dated February 15, AGENCY: Food and Drug Administration, Accordingly, under the authority 2006. HHS. delegated to me by the Administrator, ACTION: Proposed rule. the FAA proposes to amend 14 CFR part FAA AD Differences 39 as follows: Note: This AD differs from the MCAI and/ SUMMARY: The Food and Drug or service information as follows: No Administration (FDA), after PART 39—AIRWORTHINESS difference. consultation with the Environmental DIRECTIVES Other FAA AD Provisions Protection Agency (EPA), is proposing to amend FDA’s regulation on the use of 1. The authority citation for part 39 (g) The following provisions also apply to ozone-depleting substances (ODSs) in continues to read as follows: this AD: self-pressurized containers to remove Authority: 49 U.S.C. 106(g), 40113, 44701. (1) Alternative Methods of Compliance (AMOCs): The Manager, International the essential-use designation for § 39.13 [Amended] Branch, ANM–116, FAA, has the authority to epinephrine used in oral pressurized approve AMOCs for this AD, if requested metered-dose inhalers (MDIs). FDA has 2. The FAA amends § 39.13 by adding using the procedures found in 14 CFR 39.19. tentatively concluded that there are no the following new AD: Send information to ATTN: Tom Rodriguez, substantial technical barriers to Fokker Services B.V.: Docket No. FAA– Aerospace Engineer, 1601 Lind Avenue, SW., formulating epinephrine as a product 2007–29256; Directorate Identifier 2007– Renton, Washington 98057–3356; telephone that does not release ODSs, and NM–137–AD. (425) 227–1137; fax (425) 227–1149. Before using any approved AMOC on any airplane therefore epinephrine would no longer Comments Due Date to which the AMOC applies, notify your be an essential use of ODSs. If the (a) We must receive comments by October appropriate principal inspector (PI) in the essential-use designation is removed, 22, 2007. FAA Flight Standards District Office (FSDO), epinephrine MDIs containing an ODS or lacking a PI, your local FSDO. could not be marketed after a suitable Affected ADs (2) Airworthy Product: For any requirement transition period. We will hold an open (b) None. in this AD to obtain corrective actions from public meeting on the essential use of a manufacturer or other source, use these epinephrine on a date to be announced Applicability actions if they are FAA-approved. Corrective (c) This AD applies to Fokker Model F.28 actions are considered FAA-approved if they later. Mark 0070 and 0100 airplanes, certificated in are approved by the State of Design Authority DATES: Submit written or electronic any category, all serial numbers. (or their delegated agent). You are required comments by November 19, 2007.

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ADDRESSES: You may submit comments, SUPPLEMENTARY INFORMATION: Subsequently, CFCs were found to have identified by Docket No. 2007N–0262 a large number of uses, including as and/or RIN number 0910–AF92, by any Table of Contents solvents and as propellants in self- of the following methods: I. Background pressurized aerosol products, such as Electronic Submissions A. CFCs MDIs. Submit electronic comments in the B. Regulation of ODSs CFCs are very stable in the following ways: 1. The 1978 Rules troposphere, the lowest part of the • Federal eRulemaking Portal: http:// 2. The Montreal Protocol atmosphere. They move to the www.regulations.gov. Follow the 3. The 1990 Amendments to the Clean Air stratosphere, a region that begins about Act instructions for submitting comments. 10 to 16 kilometers (km) (6 to 10 miles) • Agency Web site: http:// 4. EPA’s Implementing Regulations 5. FDA’s 2002 Regulation above Earth’s surface and extends up to www.fda.gov/dockets/ecomments. II. Criteria about 50 km (31 miles) altitude. Within Follow the instructions for submitting III. Effective Date the stratosphere, there is a zone about comments on the agency Web site. IV. 2006 NDAC/PADAC Meeting 15 to 40 km (10 to 25 miles) above the Written Submissions V. Epinephrine Earth’s surface in which ozone is Submit written submissions in the A. Do Substantial Technical Barriers Exist relatively highly concentrated. This following ways: to Formulating Epinephrine Products • zone in the stratosphere is generally FAX: 301–827–6870. Without ODSs? called the ozone layer. Once in the • B. Do OTC Epinephrine MDIs Provide an Mail/Hand delivery/Courier [For stratosphere, CFCs are gradually broken paper, disk, or CD–ROM submissions]: Otherwise Unavailable Public Health Benefit? down by strong ultraviolet light, Division of Dockets Management (HFA– releasing chlorine atoms that then 305), Food and Drug Administration, 1. Does Epinephrine Provide a Greater deplete stratospheric ozone. Depletion 5630 Fishers Lane, rm. 1061, Rockville, Therapeutic Benefit Than Similar of stratospheric ozone by CFCs and MD 20852. Adrenergic Bronchodilators? other ODSs allows more ultraviolet-B To ensure more timely processing of 2. Does OTC Marketing of Epinephrine (UV-B) radiation to reach the Earth’s comments, FDA is no longer accepting MDIs Provide an Important Public surface, where it increases skin cancers comments submitted to the agency by e- Health Benefit? and cataracts, and damages some marine 3. Conclusions on the Public Health mail. FDA encourages you to continue organisms, plants, and plastics. to submit electronic comments by using Benefits of OTC Epinephrine MDIs the Federal eRulemaking Portal or the C. Does Use of OTC Epinephrine MDIs B. Regulation of ODSs agency Web site, as described Release Cumulatively Significant Amounts of ODSs Into the Atmosphere The link between CFCs and the previously in the ADDRESSES portion of or is the Release Warranted in View of depletion of stratospheric ozone was this document under Electronic the Otherwise Unavailable Important discovered in the mid-1970s. Since Submissions. Public Health Benefit? 1978, the U.S. Government has pursued Instructions: All submissions received D. Conclusions a vigorous and consistent policy, must include the agency name and VI. Environmental Impact through the enactment of laws and Docket No(s). and Regulatory VII. Analysis of Impacts regulations, of limiting the production, Information Number (RIN) (if a RIN A. Introduction B. Need for Regulation and the Objective use, and importation of ODSs, including number has been assigned) for this CFCs. rulemaking. All comments received may of This Rule C. Background 1. The 1978 Rules be posted without change to http:// 1. CFCs and Stratospheric Ozone www.fda.gov/ohrms/dockets/ 2. The Montreal Protocol In the Federal Register of March 17, default.htm, including any personal 3. Benefits of the Montreal Protocol 1978 (43 FR 11301 at 11318), FDA and information provided. For additional 4. Characteristics of Asthma EPA published rules banning, with a information on submitting comments, 5. Current U.S. Market for OTC few exceptions, the use of CFCs as see the ‘‘Comments’’ heading of the Epinephrine MDIs propellants in aerosol containers. These SUPPLEMENTARY INFORMATION section of D. Benefits and Costs of the Proposed Rule rules were issued under authority of the this document. 1. Baseline Conditions 2. Benefits of the Proposed Rule Federal Food, Drug, and Cosmetic Act Docket: For access to the docket to 3. Costs of the Proposed Rule and (the act) (21 U.S.C. 321 et seq.) and the read background documents, comments, Alternatives Toxic Substances Control Act (15 U.S.C. a transcript of, and material submitted 4. Effects on Medicaid and Medicare 2601 et seq.), respectively. FDA’s rule for, the joint meeting of the E. Alternative Phase-Out Dates (the 1978 rule) was codified as § 2.125 Nonprescription Drugs and Pulmonary- F. Sensitivity Analyses (21 CFR 2.125). These rules issued by Allergy Drugs Advisory Committee held G. Conclusion FDA and EPA had been preceded by on January 24, 2006, go to http:// VIII. Regulatory Flexibility Analysis rules issued by FDA and the Consumer IX. The Paperwork Reduction Act of 1995 www.fda.gov/ohrms/dockets/ Product Safety Commission requiring default.htm and insert the docket X. Federalism XI. Request for Comments products that contain CFC propellants number(s), found in brackets in the XII. References to bear environmental warning heading of this document, into the statements on their labeling (42 FR ‘‘Search’’ box and follow the prompts I. Background 22018, April 29, 1977; 42 FR 42780, and/or go to the Division of Dockets August 24, 1977). Management, 5630 Fishers Lane, rm. A. CFCs The 1978 rule prohibited the use of 1061, Rockville, MD 20852. Chlorofluorocarbons (CFCs) are CFCs as propellants in self-pressurized FOR FURTHER INFORMATION CONTACT: organic compounds that contain carbon, containers in any food, drug, medical Wayne H. Mitchell or Martha Nguyen, chlorine, and fluorine atoms. CFCs were device, or cosmetic. As originally Center for Drug Evaluation and Research first used commercially in the early published, the rule listed five essential (HFD–7), Food and Drug 1930s as a replacement for hazardous uses exempt from the ban. The third Administration, 5600 Fishers Lane, materials then used in refrigeration, listed essential use was for ‘‘[m]etered- Rockville, MD 20857, 301–594–2041. such as sulfur dioxide and ammonia. dose adrenergic bronchodilator human

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drugs for oral inhalation.’’ This use Montreal Protocol, held at Copenhagen industry’s participation in a smooth and describes epinephrine MDIs. in November 1992, the Parties adjusted efficient transition away from CFC- The 1978 rule provided criteria for Article 2 of the Montreal Protocol to based MDIs (San Jose, Costa Rica, 1996). adding new essential uses, and several eliminate the production and • Decision IX/19 required the Parties uses were added to the list, the last one importation of CFCs by January 1, 1996, that are developed countries to present in 1996. The 1978 rule did not provide by Parties that are developed countries an initial national or regional transition any mechanism for removing essential (Decision IV/2).3 The adjustment also strategy by January 31, 1999 (Montreal, uses from the list as alternative products indicated that it would apply, ‘‘save to Canada, 1997). were developed or CFC-containing the extent that the Parties decide to • Decision XII/2 elaborated on the products were removed from the permit the level of production or content of national or regional transition market. The absence of a removal consumption that is necessary to satisfy strategies required under Decision IX/19 procedure came to be viewed as a uses agreed by them to be essential’’ and indicated that any MDI for the deficiency in the 1978 rule, and was (Article 2A(4)). treatment of asthma or COPD approved addressed in a later rulemaking, One of the most important essential for marketing after 2000 would not be discussed in section I.B.5 of this uses of CFCs under the Montreal an ‘‘essential use’’ unless it met the document. Protocol is their use in MDIs for the criteria laid out by the Parties for treatment of asthma and chronic essential uses (Ouagadougou, Burkina 2. The Montreal Protocol Faso, 2000). obstructive pulmonary disease (COPD). • On January 1, 1989, the United States The decision on whether the use of Decision XIV/5 requested that each became a Party to the Montreal Protocol CFCs in MDIs is ‘‘essential’’ for Party report annually the quantities of on Substances that Deplete the Ozone purposes of the Montreal Protocol turns CFC and non-CFC MDIs and dry-powder Layer (Montreal Protocol) (September on whether ‘‘(1) It is necessary for the inhalers (DPIs) sold or distributed 16, 1987, 26 I.L.M. 1541 (1987)), health, safety, or is critical for the within its borders and the approval and available at http://www.unep.org/ozone/ marketing status of non-CFC MDIs and 1 functioning of society (encompassing pdfs/Montreal-Protocol2000.pdf. The cultural and intellectual aspects) and (2) DPIs. Decision XIV/5 also noted ‘‘with United States played a leading role in there are no available technically and concern the slow transition to CFC-free the negotiation of the Montreal Protocol, economically feasible alternatives or metered-dose inhalers in some Parties’’ believing that internationally substitutes that are acceptable from the (Rome, Italy, 2002). coordinated control of ODSs would best • Decision XV/5 stated that, at the standpoint of environment and health’’ protect both the U.S. and global public 17th Meeting of the Parties (in (Decision IV/25). health and the environment from December 2005) or thereafter, no Each request and any subsequent potential adverse effects of depletion of essential uses of CFCs will be exemption is for only 1 year’s duration stratospheric ozone. Currently, there are authorized for Parties that are developed (Decision V/18). Since 1994, the United 191 Parties to this treaty.2 When it countries, unless the Party requesting States and some other Parties to the joined the treaty, the United States the essential-use allocation has Montreal Protocol have annually committed to reducing production and submitted an action plan for MDIs for requested, and been granted, essential- consumption of certain CFCs to 50 which the sole active ingredient is use exemptions for the production or percent of 1986 levels by 1998 (Article albuterol. Among other items, the action importation of CFCs for their use in 2(4) of the Montreal Protocol). It also plan should include a specific date by MDIs for the treatment of asthma and agreed to accept an ‘‘adjustment’’ which the Party plans to cease procedure, by which, following COPD (see, among others, Decisions VI/ requesting essential-use allocations of assessment of the existing control 9 and VII/28). The exemptions have CFCs for albuterol MDIs to be sold or measures, the Parties could adjust the been consistent with the criteria distributed in developed countries4 scope, amount, and timing of those established by the Parties, which make (Nairobi, Kenya, 2003). control measures for substances already the grant of an exemption contingent on • Decision XVII/5 stated that Parties subject to the Montreal Protocol. As the a finding that the use for which the that are developed counties should evidence regarding the impact of ODSs exemption is being requested is provide a date to the Ozone Secretariat5 on the ozone layer became stronger, the essential for health, safety, or the Parties used this adjustment procedure functioning of society, and that there are 4Our obligation under XV/5 was met by our final to accelerate the phase-out of ODSs. At no available technically and rule eliminating the essential use status of albuterol economically feasible alternatives or (70 FR 17168, April 4, 2005). the fourth Meeting of the Parties to the 5The Ozone Secretariat is the Secretariat for the substitutes that are acceptable from the Montreal Protocol and the Vienna Convention for 1FDA has verified all Web site addresses cited in standpoint of health or the environment the Protection of the Ozone Layer (the Vienna this document, but FDA is not responsible for any (Decision IV/25). Convention) (March 22, 1985, 26 I.L.M. 1529 subsequent changes to the Web sites after this Phasing out the use of CFCs in MDIs (1985)), available at http://hq.unep.org/ozone/pdfs/ document has published in the Federal Register. for the treatment of asthma and COPD viennaconvention2002.pdf. Based at the United 2The summary descriptions of the Montreal Nations Environment Programme (UNEP) offices in Protocol and decisions of Parties to the Montreal has been an issue of particular interest Nairobi, Kenya, the Secretariat functions in Protocol contained in this document are presented to the Parties to the Montreal Protocol. accordance with Article 7 of the Vienna Convention here to help you understand the background of the Several decisions of the Parties have and Article 12 of the Montreal Protocol. action we are taking. These descriptions are not dealt with the transition to CFC-free The main duties of the Secretariat include the intended to be formal statements of policy regarding following: the Montreal Protocol. Decisions by the Parties to MDIs, including the following • Arranging for and servicing the Conference of the Montreal Protocol are cited in this document in decisions: the Parties, Meetings of the Parties, their the conventional format of ‘‘Decision IV/2,’’ which • Decision VIII/10 stated that the Committees, the Bureaux, Working Groups, and refers to the second decision recorded in the Report Parties that are developed countries Assessment Panels; of the Fourth Meeting of the Parties to the Montreal • Arranging for the implementation of decisions Protocol on Substances That Deplete the Ozone would take various actions to promote resulting from these meetings; Layer. Reports of Meetings of the Parties to the • Monitoring the implementation of the Vienna Montreal Protocol may be found on the United 3Production of CFCs in economically less- Convention and the Montreal Protocol; Nations Environment Programme’s Web site at developed countries is being phased out and is • Reporting to the Meetings of the Parties and to http://ozone.unep.org/Meeting_Documents/mop/ scheduled to end by January 1, 2010. See Article the Implementation Committee; index.shtml. 2A of the Montreal Protocol. Continued

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before the 18th Meeting of the Parties ozone protection provisions of the 1990 49396, July 30, 2002, and 67 FR 58678, (October 30 to November 3, 2006) by amendments are codified in part 82 of September 17, 2002). The 2002 final which time a regulation or regulations title 40 of the Code of Federal rule listed as a separate essential use will have been proposed to determine Regulations (40 CFR part 82). (See 40 each active moiety7 marketed under the whether MDIs, other than those that CFR 82.1 for a statement of intent.) Like 1978 rule as essential uses for metered- have albuterol as the only active the 1990 amendments, EPA’s dose steroid human drugs for oral ingredient, are nonessential (Dakar, implementing regulations contain two inhalation and metered-dose adrenergic Senegal, 2005). separate prohibitions, one on the bronchodilator human drugs for oral production and import of CFCs (subpart inhalation; eliminated the essential-use 3. The 1990 Amendments to the Clean A of 40 CFR part 82) and the other on designations in § 2.125(e) for metered- Air Act the sale or distribution of products dose steroid human drugs for nasal In 1990, Congress amended the Clean containing CFCs (40 CFR 82.66). inhalation and for products that were no Air Act to, among other things, better The prohibition on production and longer marketed; set new standards to protect stratospheric ozone (Public Law import of CFCs contains an exception determine when a new essential-use No. 101–549, November 15, 1990) (the for essential uses and, more specifically, designation should be added to § 2.125; 1990 amendments). The 1990 for essential MDIs. The definition of and set standards to determine whether amendments were drafted to essential MDI at 40 CFR 82.3 requires the use of an ODS in a medical product complement, and be consistent with, that the MDI be intended for the remains essential. our obligations under the Montreal treatment of asthma or COPD, be Protocol (see section 614 of the Clean essential under the Montreal Protocol, II. Criteria Air Act (42 U.S.C. 7671m)). Section and if the MDI is for sale in the United Among other changes, the 2002 final 614(b) of the Clean Air Act provides States, be approved by FDA and listed rule, in revised § 2.125(g)(2), establishes that, in the case of a conflict between as essential in FDA’s regulations at a standard for removing an essential-use any provision of the Clean Air Act and § 2.125 (21 CFR 2.125). designation for any drug after January 1, any provision of the Montreal Protocol, The prohibition on the sale of 2005, that would apply to a drug for the more stringent provision will products containing CFCs includes a which there is no acceptable non-ODS govern. Section 604 of the Clean Air Act specific prohibition on aerosol products alternative with the same active moiety. requires the phase-out of the production and other pressurized dispensers. The The process for removing the essential- of CFCs by 2000 (42 U.S.C. 7671c),6 aerosol product ban contains an use designation for such a drug must while section 610 of the Clean Air Act exception for medical devices listed in include a consultation with a relevant (42 U.S.C. 7671i) required EPA to issue § 2.125(e). The term ‘‘medical device’’ is advisory committee and an open public regulations banning the sale or used with the same meaning it was meeting, in addition to a proposed rule distribution in interstate commerce of given in the 1990 amendments and and a final rule. The criterion nonessential products containing CFCs. includes drugs as well as medical established for removing the essential Sections 604 and 610 provide devices. use in such circumstances is that it no exceptions for ‘‘medical devices.’’ longer meets the criteria specified in 5. FDA’s 2002 Regulation Section 601(8) (42 U.S.C. 7671(8)) of the revised § 2.125(f) for adding a new Clean Air Act defines ‘‘medical device’’ In the 1990s, we decided that § 2.125 essential use (§ 2.125(g)(2)). The criteria as: required revision to better reflect our in § 2.125(f) are: ‘‘(i) Substantial any device (as defined in the Federal obligations under the Montreal Protocol, technical barriers exist to formulating Food, Drug, and Cosmetic Act (21 U.S.C. the 1990 amendments, and EPA’s the product without ODSs; (ii) The 321)), diagnostic product, drug (as regulations, and to encourage the product will provide an unavailable defined in the Federal Food, Drug, and development of ozone-friendly important public health benefit; and (iii) Cosmetic Act), or drug delivery system- alternatives to medical products Use of the product does not release (A) if such device, product, drug, or containing CFCs. In particular, as cumulatively significant amounts of drug delivery system utilizes a class I or acceptable alternatives that did not ODSs into the atmosphere or the release class II substance for which no safe and contain CFCs or other ODSs came on the is warranted in view of the unavailable effective alternative has been developed, market, there was a need to provide a important public health benefit.’’ and where necessary, approved by the mechanism for removing essential uses The three criteria in § 2.25(f)(1) are Commissioner [of Food and Drugs]; and from the list in § 2.125(e). In the Federal linked by the word ‘‘and’’. Because the (B) if such device, product, drug, or Register of March 6, 1997 (62 FR three criteria are linked by ‘‘and’’ (as drug delivery system, has, after notice 10242), we published an advance notice and opportunity for public comment, of proposed rulemaking (the 1997 7Section 314.108(a) (21 CFR 314.108(a)) defines been approved and determined to be ANPRM) in which we outlined our ‘‘active moiety’’ as the molecule or ion, excluding essential by the Commissioner [of Food those appended portions of the molecule that cause then-current thinking on the content of the drug to be an ester, salt (including a salt with and Drugs] in consultation with the an appropriate rule regarding ODSs in hydrogen or coordination bonds), or other Administrator [of EPA]. products FDA regulates. We received noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the 4. EPA’s Implementing Regulations almost 10,000 comments on the 1997 ANPRM. In response to the comments, physiological or pharmacological action of the drug EPA regulations implementing the substance. When describing the various essential we revised our approach and drafted a uses, we will generally refer to the active moiety, Montreal Protocol and the stratospheric proposed rule published in the Federal for example, albuterol, as opposed to the active Register of September 1, 1999 (64 FR ingredient, which, using the same example, would • Representing the Convention and the Protocol; be albuterol sulfate. When discussing particular and 47719) (the 1999 proposed rule). We indications and other material from the approved • Receiving and analyzing data and information received 22 comments on the 1999 labeling of a drug product, we will generally use the from the Parties on the production and proposed rule. After minor revisions in brand name of the product, which, using the same consumption of ODSs. response to these comments, we example would be PROVENTIL HFA (among 6In conformance with Decision IV/2, EPA issued published a final rule in the Federal others). In describing material from treatises, regulations accelerating the complete phase-out of journals, and other non-FDA approved CFCs, with exceptions for essential uses, to January Register of July 24, 2002 (67 FR 48370) publications, we will generally follow the usage in 1, 1996 (58 FR 65018, December 10, 1993). (the 2002 final rule) (corrected in 67 FR the original publication.

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opposed to ‘‘or’’), failure to meet any product provides. In evaluating whether Given this proposed finding that the single criterion satisfies the threshold continuing the essential-use designation first part of the third criterion is not under the regulation for determining of an MDI would result in the product satisfied, the threshold for the removal that the use is not essential. releasing significant quantities of ODSs, of the essential-use designation for We discussed these criteria in the in light of past policy statements (2002 epinephrine under § 2.125(f)(1)(iii) is preamble to the 1999 proposed rule. A final rule p. 48380) and the current state met if we also find that the second part key point in our discussion of technical of the phase-out of ODSs, the release of of the third criterion is not satisfied: it barriers was: Generally, FDA intends the CFCs from epinephrine MDIs is provides an otherwise unavailable term ‘‘technical barriers’’ to refer to currently significant and as the phase- important public health benefit which difficulties encountered in chemistry out of ODSs continues throughout the warrants the cumulatively significant and manufacturing. A petitioner would world, the significance of the quantities release of the ODS. have to establish that it evaluated all of CFCs released by epinephrine MDIs As noted previously, because the available alternative technologies and will increase. three criteria in § 2.125(f)(1) are linked explain in detail why each alternative In applying the first part of the third by the word ‘‘and,’’ failure to meet any was unusable to demonstrate that criterion, we are guided by previous single criterion may result in a substantial technical barriers exist (1999 policy statements. The United States determination that the use is not proposed rule at 47721). evaluated the environmental effect of essential. Accordingly, if we find that In applying the ‘‘technical barriers’’ eliminating the use of all CFCs in an the product fails to provide an criterion, we will be looking at the otherwise unavailable important health environmental impact statement in the results of reformulation efforts for benefit (criterion two), this would meet 1970s (see 43 FR 11301, March 17, similar products, as well as statements the threshold under the regulation for a 1978). As part of that evaluation, FDA made about the manufacturer’s finding that the use of the product is not concluded that the continued use of particular efforts to reformulate their essential, and we would not necessarily CFCs in medical products posed an product or products. need to reach the last step under the unreasonable risk of long-term Similarly, in discussing what is ‘‘an third criterion (balancing the important biological and climatic impacts (see unavailable important public health health benefit against the release of the Docket No. 1996N–0057 formerly 96N– benefit,’’ we said: The agency intends to ODS to determine if the release is 0057). Congress later enacted provisions give the phrase ‘‘unavailable important warranted). Assuming, however that we public health benefit’’ a markedly of the Clean Air Act that codified the do analyze the third criterion, then, different construction from the [phrase decision to fully phase out the use of because of our tentative conclusion that used in the 1978 rule] ‘‘substantial CFCs over time (see 42 U.S.C. 7671 et the release of ODSs from epinephrine health benefit.’’ A petitioner should seq. (enacted November 15, 1990)). We MDIs is cumulatively significant, we show that the use of an ODS would save note that the environmental impact of would need to conduct the balancing lives, significantly reduce or prevent an individual uses of nonessential CFCs inquiry under the second part of the important morbidity, or significantly must not be evaluated independently, third criterion. We will discuss our increase patient quality of life to but rather must be evaluated in the tentative conclusions on how the support a claim of important public context of the overall use of CFCs. second part of the third criterion applies health benefit (1999 proposed rule at Cumulative impacts can result from to OTC epinephrine MDIs in section V.C 47722). individually minor, but collectively of this document. In determining whether a drug significant, actions that take place over The criteria in § 2.125(g)(2) (which product provides an otherwise a period of time (40 CFR 1508.7). refers to those found in § 2.125(f)(1)) unavailable important public health Significance cannot be avoided by that we are using in this rulemaking are benefit, our primary focus is on the breaking an action down into small different from those in § 2.125(g)(3) and availability of non-ODS products that components (40 CFR 1508.27(b)(7)). (g)(4). Section 2.125(g)(2) specifically provide equivalent therapeutic benefits Currently, MDIs for the treatment of addresses the situation where there is for patients who are currently using the asthma and COPD are the only legal use no marketed non-ODS product CFC MDIs. If therapeutic alternatives for newly produced or imported CFCs containing the active moiety listed as an exist for everyone using the CFC MDI, (see 71 FR 58504 (October 4, 2006)). essential use, while § 2.125(g)(3) and we would then determine that the CFC Although it may appear to some that the (g)(4) apply to situations where there is MDI does not provide an otherwise CFCs released from MDIs represent at least one marketed non-ODS product unavailable important public health insignificant quantities of ODSs, and with the listed active moiety. Section benefit. In the case of epinephrine MDIs, therefore should be exempt, the 2.125(g)(2) permits FDA to remove an the fact that they are marketed over-the- elimination of CFC use in MDIs is one essential use even if a current essential- counter (OTC), while the therapeutic of the final steps in the overall phase- use active moiety is not reformulated, alternatives for epinephrine MDIs are out of CFC use. The release of ODSs provided that sufficient alternative prescription drugs, makes the analysis from some of the MDIs may be relatively products exist to meet the needs of of whether everyone is adequately small compared to total quantities that patients, because the essential use served by the therapeutic alternatives were released 2 or 3 decades ago, but if would no longer provide an otherwise more complicated. each use that resulted in the release of unavailable important health benefit. Under the third criterion, the relatively small quantities of ODSs were Therefore, the analysis we use here is threshold for removing the essential use provided an exemption, the cumulative not identical to the analysis we used designation is satisfied unless we find effect would be to prevent the under § 2.125(g)(4) in the recent either: (1) The use of the product does elimination of ODS releasing products. rulemaking to remove the essential use not release cumulatively significant This would prevent the full phase-out for albuterol (70 FR 17168, April 4, amounts of ODSs into the atmosphere; envisioned by the Clean Air Act and the 2005). However, the basic concern of or (2) the release, although cumulatively Montreal Protocol. Therefore, we protecting the public health underlies significant, is warranted in view of the tentatively conclude that the release of all of the criteria. Therefore, our otherwise unavailable important public ODSs from epinephrine MDIs is analyses are similar, and we have found health benefit that the use of the drug cumulatively significant. it useful to borrow concepts from the

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more specific provisions of § 2.125(g)(3) 32030, June 11, 2007). We have, comments from manufacturers of and (g)(4) to help give more structure to therefore, tentatively concluded that the albuterol HFA MDIs on this issue. our analysis under the broader language December 31, 2010, effective date would In proposing a December 31, 2010, of § 2.125(f)(1). be appropriate for a final rule removing effective date, we expect that 2010 would be a transition year characterized III. Effective Date the essential-use designation for OTC epinephrine MDIs. We invite comment by declining production of OTC We are proposing that any rule on the proposed effective date of epinephrine MDIs. If a December 31, finalizing the removal of the essential December 31, 2010, as well as possible 2010, effective date is established by use for OTC epinephrine MDIs have an alternative effective dates, such as this rulemaking, we anticipate that other effective date of December 31, 2010. December 31, 2011 or 2012. administrative actions taken by EPA and Because there are therapeutic FDA would reflect the concept of 2010 alternatives which are marketed as In determining an appropriate being a transition year. prescription drugs, in determining the effective date, we have kept in mind The sale of remaining stocks of CFC appropriate effective date for this that albuterol MDIs that use the MDIs by manufacturers, wholesalers, rulemaking, we will consider both: (1) hydrofluoroalkane HFA–134a (HFA) as and retailers was a consideration in Whether adequate time exists to provide a propellant are a primary therapeutic setting the effective date of the albuterol patient education for users of OTC alternative to OTC epinephrine MDIs, rule (70 FR 17168, 17179, April 4, epinephrine MDIs, particularly those because both drugs are in the same 2005). We believe that this who do not consult doctors, therapeutic class (short-acting inhaled consideration is appropriate for this pharmacists, and other health care beta-agonist bronchodilators), albuterol rulemaking also. In evaluating the professionals; and (2) whether adequate is the only member of the class available period of time needed to sell remaining production capacity and supplies are in an HFA MDI, and no members of the stocks of OTC epinephrine MDIs, a available to meet the new, presumably class are available as a DPI.8 Sales of factor that must be considered is the increased, demand for the therapeutic OTC epinephrine MDIs have totaled expiration dating for the relevant alternatives once OTC epinephrine approximately 4.5 million MDIs a year. products. Both PRIMATENE MIST and MDIs are no longer sold. We are confident that there will be the OTC epinephrine MDIs made by Patient education for any transition adequate supplies of albuterol HFA Armstrong Pharmaceuticals, Inc. away from OTC epinephrine MDIs MDIs to meet the needs of all users of (Armstrong) have expiration dates set at presents unique concerns. Much of the albuterol CFC MDIs by December 31, 24 months after manufacture. Drug thinking about patient education on the 2008 (the date on which albuterol MDIs products are not generally sold right up transition from CFC MDIs has focused will no longer be designated an essential to the expiration date. Drugs are on the dissemination of information use).9 Although we have limited data on generally sold well before the expiration through physicians, pharmacists, and production increases above current date, allowing the purchasers a other health care professionals. This demand for 2009, 2010, and later, we significant amount of time to use the information could be given orally by believe that by December 31, 2010, drug before it reaches its expiration health care professionals, or the date; therefore, we believe that all OTC albuterol HFA production will be able information could be available in the epinephrine MDIs manufactured prior to meet any increased demand caused professionals’ offices or pharmacies for to publication of a final rule based on by this rulemaking. This proposed patients to read. Because epinephrine this proposal should be sold by MDIs are sold OTC, many purchasers effective date is 1 year later than the December 31, 2010. will not interact with a health care effective date that we proposed in the We are tentatively proposing a provider. New avenues of recently published proposed rule to December 31, 2010, effective date based communication will have to be opened eliminate the essential-use designation on our preliminary assumption that to reach all OTC epinephrine MDI users. for MDIs containing flunisolide, there will not be an inhaled epinephrine Many OTC epinephrine MDI users may triamcinolone, metaproterenol, OTC drug product that does not contain need to be provided information to help pirbuterol, albuterol and ipratropium in ODSs on the market in the foreseeable them select a physician. Some OTC combination, cromolyn, and nedocromil future. We strongly urge interested epinephrine MDI users who face (72 FR 32030, June 11, 2007). As we individuals to submit detailed economic barriers to appropriate health said in that proposed rule, many of the information on whether inhaled- care may need even more time to find patients using some of those drugs epinephrine will be available in a non- and avail themselves of free or low-cost would switch to albuterol HFA inhalers. ODS formulation and when a non-ODS health care and prescription drug We believe that the additional time inhaled epinephrine product can programs (see section V.B.2.b of this required for the needed patient reasonably be expected to be on the document). These factors have led us to education on alternatives to OTC market. We also specifically request believe that a transition away from OTC epinephrine MDIs will also provide comment on whether publishing a final epinephrine MDIs may be more difficult additional time to scale up production rule or the effective date of any such than transitions in which patients of albuterol HFA MDIs. This additional rule should be affected by the additional change from one prescription drug to time should provide greater assurance information that we receive concerning another prescription drug, and that there will be adequate supplies of the availability of an inhaled accordingly that any effective date for albuterol HFA MDIs for all patients who epinephrine OTC drug product that such a rulemaking should provide for a use them. We specifically invite does not contain ODSs. longer transition period than the IV. 2006 NDAC/PADAC Meeting transition period for the recently 8Neither HFA MDIs nor DPIs release ODSs. HFA published proposed rule to eliminate MDIs and DPIs are generally considered to be the Section 2.125(g)(2) requires that we the essential-use designation for MDIs non-ODS drug products that are most comparable consult an advisory committee before containing flunisolide, triamcinolone, to CFC MDIs in terms of portability and ease of use. we remove an essential-use designation 9Current information indicates that production of metaproterenol, pirbuterol, albuterol albuterol HFA MDIs will be adequate to meet the when there is no non-ODS product with and ipratropium in combination, current demand for albuterol MDIs much earlier the same active moiety. We consulted cromolyn, and nedocromil (72 FR than December 31, 2008. the Nonprescription Drug Advisory

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Committee (NDAC) and the Pulmonary- to purchase OTC epinephrine MDIs. (albuterol) MDIs for sale by Schering Allergy Drugs Advisory Committee Wyeth presented data at the NDAC/ Corporation (Schering). Ivax Corp. has (PADAC) on the essential-use status of PADAC meeting estimating that 2 to 3 licensed HFA MDI technology patents OTC MDIs containing epinephrine at a million people with asthma use OTC from 3M and manufactures PROAIR joint committee meeting held on epinephrine MDIs (meeting transcript p. HFA (albuterol) MDIs. We have not been January 24, 2006 (NDAC/PADAC 51, Wyeth slide 19). Based on the 2005 presented with any evidence that Wyeth meeting).10 Presentations were made by National Health Interview Survey could not obtain patent licenses or representatives of Wyeth Consumer (NHIS), the Centers for Disease Control arrange for contract manufacturing by a Health (Wyeth), two patient advocacy and Prevention’s National Center for patent holder. and public policy groups, and physician Health Statistics (NCHS) has estimated At least nine different active moieties organizations. Seven of the joint that 7.7 percent of the U.S. population have been formulated as HFA MDIs for committee members recommended that currently has asthma (Ref. 1). Using an the treatment of asthma and COPD in epinephrine be retained as an essential estimate of the U.S. population of 300 the United States and abroad.13 HFA use, while eleven members million,12 we can estimate that MDIs have been formulated with both recommended that the essential-use approximately 23 million people in the suspensions and solutions. Albuterol designation be removed. The opinions United States currently have asthma. and levalbuterol are close chemical expressed by the NDAC and PADAC Epinephrine is also an active analogs of epinephrine. Given the (NDAC/PADAC) members and other ingredient in many other drug products. chemical similarity between them and participants in the NDAC/PADAC It is used in a self-injectable dosage form the success with reformulating albuterol meeting will be discussed below. for treatment of severe allergic reactions. (as albuterol sulfate in PROAIR HFA, This NDAC/PADAC meeting should EPIPEN is an example of epinephrine in PROVENTIL HFA, and VENTOLIN not be confused with the open public this dosage form. Epinephrine is also HFA) and levalbuterol (as levalbuterol meeting on the essential-use status of available OTC as a solution for use in an tartrate in XOPENEX), there appears to OTC MDIs containing epinephrine we electrically powered nebulizer for the be no technical reason why epinephrine will be holding in the near future. We treatment of asthma. This rulemaking cannot be successfully reformulated into will publish a notice for that meeting in will not affect the availability of these an HFA MDI. Wyeth said at the NDAC/ the Federal Register shortly. non-MDI drug products. PADAC meeting that early attempts to V. Epinephrine A. Do Substantial Technical Barriers formulate an epinephrine HFA MDI were characterized by higher pressures Epinephrine is a short-acting Exist to Formulating Epinephrine and quantities of alcohol that provided adrenergic bronchodilator used in the Products Without ODSs? unacceptable sensations to users of the treatment of asthma. A new drug As we said in the 2002 final rule, we product, including an unpleasant taste application (NDA) for OTC epinephrine intend the term ‘‘technical barriers’’ to 14 MDIs was approved in 1956. refer to difficulties encountered in of alcohol (Wyeth briefing material, p. Epinephrine was included in the 1978 chemistry and manufacturing. To 1–7; meeting transcript, p. 87). These do rule under the provision designating demonstrate that substantial technical not seem to represent technical barriers; ‘‘[m]etered-dose adrenergic barriers exist, it will have to be rather they seem to be the type of bronchodilator human drugs for oral established that all available alternative problems routinely encountered in the inhalation’’ as an essential use. technologies have been evaluated and development of a new product that Approved NDAs for OTC epinephrine why each alternative is unusable (2002 require prototypes to be reengineered. MDIs are currently held by Wyeth and final rule at 48373). Wyeth did not Indeed, Wyeth did not seem to truly Armstrong, (a subsidiary of Amphastar present any significant data on technical believe that there were technical Pharmaceuticals, Inc.). Wyeth markets barriers to formulating an inhaled barriers to development of an their OTC epinephrine MDIs as epinephrine product without ODSs at epinephrine HFA MDI, predicting that PRIMATENE MIST, while Armstrong the NDAC/PADAC meeting. At the they would have a product developed labels their product as ‘‘house brands’’ NDAC/PADAC meeting, Wyeth said that and clinically tested by 2011, and for certain retail pharmacies. they had been trying to reformulate or attributing their earlier difficulties to a Epinephrine MDIs are the only MDIs for outsource their product for over a lack of in-house expertise (Wyeth treatment of asthma (or any other decade and mentioned unacceptable briefing material, p. 1–7). FDA has had disease) that are approved for OTC prototypes, but they mentioned that a experience with several firms use.11 Customers do not need a significant difficulty in reformulation reformulating products from ODS prescription from a health care provider was avoiding designs that would containing MDIs to non-ODS products. infringe patents held by 3M Co. (3M) Based on our experience with those 10The transcript of the NCPAC/PADAC meeting, and GlaxoSmithKline (GSK) (meeting reformulation efforts, it seems highly slides used in presentations made at the joint transcript, pp. 86–88). It should be kept unlikely that a non-ODS inhaled meeting, and written material presented to the epinephrine drug product will be committees for the meeting may be found at http:// in mind that patent licenses and www.fda.gov/ohrms/dockets/ac/cder06.html. contract manufacturing by patent 13 11The OTC monograph for Cold, Cough, Allergy, holders have been very frequently used The nine moieties formulated as HFA MDIs are Bronchodilator, and Antiasthmatic Drug Products during the current transition away from albuterol, beclomethasone, budesonide, fenoterol, permits OTC marketing of epinephrine in a hand- fluticasone, flunisolide, formoterol, ipratropium, held rubber nebulizer for use in the treatment of CFC MDIs. An example of this is 3M’s and salmeterol. While a salmeterol DPI asthma (21 CFR part 341). While this product did manufacture of, and patent licensing for, (SEREVENT) has been approved in the United not use CFCs, all of the information available to us albuterol HFA MDIs. 3M holds patents States, salmeterol HFA MDIs have only been shows that such products are no longer marketed. on HFA MDI technology and it also approved overseas. There are no approved fenoterol The OTC monograph for Cold, Cough, Allergy, or formoterol products in the United States, but Bronchodilator, and Antiashtmatic Drug Products manufactures PROVENTIL HFA fenoterol HFA MDIs and formoterol HFA MDIs have permits OTC marketing of oral dosage forms of been approved in several foreign countries. ephedrine. Ephedrine is not available in an MDI. In 12The U.S. Census’ estimate of the U.S. 14PRIMATENE MIST contains 35 percent alcohol addition, OTC ephedrine products have a slower Population was 299,948,296 as of October 10, 2006, and other MDIs also contain alcohol. Wyeth did not onset of action than epinephrine MDIs, and 1804 GMT, with an estimated net increase in the reveal the amount of alcohol in their prototype or therefore they cannot be considered a suitable population of 1 person every 11 seconds. See http:// explain why the amount of alcohol could not be alternative to OTC epinephrine MDIs. www.census.gov/population/www/popclockus.html. reduced or the taste otherwise minimized.

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developed and clinically tested until essential-use designation for are no clinical data to support a well after 2011. As we mentioned epinephrine. Accordingly, we will conclusion that this perceived quicker before, we are particularly interested in discuss some of the questions on which relief provided by epinephrine leads to receiving comment on current efforts on we would be particularly interested in better outcomes. Therefore, we do not developing non-ODS inhaled receiving comments that would be believe that this represents a ‘‘otherwise epinephrine drug products that would relevant in reaching a conclusion on the unavailable important public health be suitable for OTC sale, including any public health benefits of OTC benefit.’’ discernible impediments to such efforts. epinephrine MDIs. Wyeth presented another study of the Wyeth said that an epinephrine DPI 1. Does Epinephrine Provide a Greater treatment of nocturnal asthma that was not a viable alternative to the concluded that OTC epinephrine MDIs epinephrine MDI, but without any Therapeutic Benefit Than Similar Adrenergic Bronchodilators? can ‘‘achieve the same benefit as elaboration (Wyeth briefing material, p. albuterol’’ MDIs (Ref. 4, p. 533).17 1–7). The DPI has proven to be a very During the last several years, four However, as pointed out by NDAC/ successful dosage form. At least nine prescription HFA MDIs with two PADAC members, the frequency of different moieties have been formulated different forms of albuterol have come doses of epinephrine used in this study as DPIs for treatment of asthma and onto the market: • were several times the amount approved COPD in the United States or overseas.15 Albuterol sulfate MDI (PROAIR in labeling (this was also true, but to a Alkermes, Inc., developed a large dose HFA); • smaller degree, for albuterol in this epinephrine DPI for investigations into Albuterol sulfate MDI (PROVENTIL study).18 Further, this was a limited using an epinephrine DPI for treatment HFA); study with only eight subjects • Albuterol sulfate MDI (VENTOLIN of anaphylaxis. While this product has completing the evaluations. These HFA); and not been approved by FDA and it is not elements made the utility of this study • Levalbuterol tartrate MDI intended for the treatment of asthma, it for purposes of this rulemaking very does show that epinephrine can be (XOPENEX HFA). These products use HFA as a questionable, and even if these formulated into a DPI (Refs. 2 and 3). questions were ignored, the study Thus, all of the evidence before us replacement for ODSs, which does not affect stratospheric ozone. Albuterol and shows, at best, that epinephrine is indicates that epinephrine can be roughly as effective as, but not more formulated into a drug product that does epinephrine are both adrenergic bronchodilators. Albuterol MDIs are effective than, albuterol. not release ODSs. The facts presented by In the United States, the generally Wyeth at the NDAC/PADAC meeting therapeutic alternatives to OTC epinephrine MDIs and are, by far, the recognized standard of care for asthma did not indicate that there are technical is set forth in the National Heart, Lung, barriers to the development of a non- most widely prescribed short-acting bronchodilators. To determine whether and Blood Institute’s Expert Panel ODS epinephrine product, despite the Report 2: Guidelines for the Diagnosis conclusions that Wyeth presented at the epinephrine provides an otherwise unavailable important public health and Management of Asthma (EPR–2) meeting. However, as noted previously, (Ref. 5).19 The National Heart, Lung, and we are especially interested in receiving benefit, we should compare OTC epinephrine MDIs to albuterol HFA Blood Institute is one of the National public comment concerning any such Institutes of Health. In the 2002 update technical barriers that may exist. MDIs. The labeled indication for the OTC epinephrine MDIs is ‘‘for to EPR–2 (Ref. 6), we find the latest B. Do OTC Epinephrine MDIs Provide temporary relief of occasional symptoms updates to the standard. an Otherwise Unavailable Important of mild asthma.’’ The comparable In several points in Wyeth’s written, Public Health Benefit? labeled indication for the albuterol HFA oral, and visual presentation for the Because we have reached a tentative MDIs is ‘‘for treatment or prevention of NDAC/PADAC meeting, it was stated conclusion that there are no substantial bronchospasm with reversible that use of epinephrine was consistent technical barriers to formulating obstructive airway disease.’’ OTC with the National Heart, Lung and epinephrine into a non-ODS product, epinephrine MDIs and three of the Blood Institute’s asthma treatment we do not believe it is necessary at this albuterol HFA MDIs are indicated for guidelines (Ref. 5) (frequently called the time to reach a conclusion on the public adults and children 4 years of age and second Expert Panel Report or EPR–2), health benefits of OTC epinephrine older.16 The labeled indications for the issued as part of the National Asthma MDIs. However, this issue was albuterol HFA MDIs cover all patients discussed at length at the NDAC/ described in the labeled indication for 17The author of the study report did not appear OTC epinephrine MDIs. to view the study as supporting the OTC use of PADAC meeting and we are keenly epinephrine MDIs, stating that the results of the interested in the potential public health Clinical data presented by a study do not imply that it is safe for people with benefits of having epinephrine MDIs representative of Wyeth at the NDAC/ asthma to self-medicate without physician available OTC. We will evaluate and PADAC meeting indicated that OTC intervention and that results of the study indicate epinephrine MDIs may be slightly that nonprescription epinephrine presents the same weigh those public health benefits risk of delaying patients from seeking medical care before issuing any final rule on the quicker to onset of action than albuterol as other beta-agonists. The report concluded with MDIs, but they have a significantly a statement that a larger study is required before 15The nine moieties formulated as DPIs are shorter duration of action (Wyeth epinephrine can be recommended as rescue therapy albuterol, beclomethasone, budesonide, fluticasone, briefing statement at p. 1–9). The when a prescription beta2-agonist MDI is not formoterol, mometasone, salmeterol, terbutaline, slightly quicker onset of action may accessible (Ref. 3). and tiotropium. While albuterol HFA MDIs have 18The author of the study report recognized that been approved in the United States, albuterol DPIs explain why some people with asthma the large number of actuations might be impractical are not currently marketed in the United States, but describe OTC epinephrine MDI as (Ref. 43). are approved overseas. A terbutaline CFC MDI and working better than prescription drugs. 19The Guidelines represent best practices and are other terbutaline products have been approved in The slightly quicker onset of action is a recognized as the clinical standard of care for the United States, but terbutaline DPIs have only treatment of asthma. See, e.g., http:// been approved overseas. There are no approved pharmacodynamic assessment, but there www.asthmanow.net/care.html; http:// formoterol products in the United States, but www.colorado.gov/bestpractices/index.html; http:// formoterol DPIs have been approved in several 16PROAIR HFA is indicated for adults and www.doh.wa.gov/CFH/asthma/publications/plan/ foreign countries. children 12 years of age and older. health-care.pdf.

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Education and Prevention Program.20 benefits of OTC epinephrine MDIs, and treatment of such patients. No evidence The EPR–2, as updated, is widely seen if OTC epinephrine MDIs were has been presented to us, in the course as representing the generally recognized prescription drugs, as albuterol HFA of this rulemaking, to indicate how standard of care for asthma in the MDIs are, our analysis would be nearly asthma differs from other serious United States.21 Wyeth stated in its complete. However, the epinephrine diseases in a way that warrants having written materials that epinephrine is not MDIs, PRIMATENE MIST and the an OTC treatment available. mentioned specifically in the EPR–2 Armstrong products, are the only MDIs These facts would support a (Wyeth briefing material, p. 1–8; for treatment of asthma that are conclusion that any added convenience meeting transcript, pp. 50–51; Wyeth marketed OTC. We, therefore, have to of OTC availability of epinephrine for slide 18). FDA disagrees with these examine more questions on the possible patients who have been prescribed statements. The 2002 update to the public health benefits of the continued drugs for the treatment of asthma, such EPR–2 states that ‘‘[n]onselective agents OTC marketing of epinephrine CFC as albuterol MDIs, does not provide an (i.e., epinephrine, isoproterenol, MDIs. ‘‘important public health benefit.’’ metaproterenol) are not recommended b. Do OTC epinephrine MDIs provide 2. Does OTC Marketing of Epinephrine due to their potential for excessive an important health benefit for people MDIs Provide an Important Public cardiac stimulation, especially in high who have poor access to adequate Health Benefit? doses’’ (Ref. 6, p. 120). While health care? Wyeth and several recognizing the possibility that the Our discussion on the public health members of NDAC and PADAC have concerns expressed in the EPR–2 about benefit of OTC marketing of epinephrine stated that a significant number of cardiovascular risk may be overstated is largely informed by the data people with asthma do not have (see Refs. 4 and 9), we do not need to presented and the opinions expressed at adequate access to health care, and a reach a conclusion on the relative the NDAC/PADAC meeting. significant number of these people with cardiovascular risk of the use of a. Is patient convenience an important asthma use OTC epinephrine MDIs. To epinephrine compared to the use of public health benefit? Wyeth asserted at examine the public health benefit of albuterol. FDA is unaware of any the NDAC/PADAC meeting that the OTC marketing of epinephrine MDIs we evidence comparing epinephrine and convenience of patients having an OTC must examine (1) The number of people albuterol at recommended doses MDI for asthma provides an ‘‘important with asthma who use epinephrine indicating that the cardiovascular safety public health benefit’’ (meeting because of inadequate access to health of epinephrine is better than that of transcript, p. 66). Having this OTC care providers able to diagnose asthma albuterol. product available would allow patients and prescribe treatments other than A voting consultant with NDAC who run out of their prescribed epinephrine, and (2) the extent that OTC characterized the OTC epinephrine MDI medication and cannot get a refill epinephrine benefits these people. We as an ‘‘inferior medicine’’ (meeting authorization from their physician to go are particularly interested in the public transcript, p. 181). She admitted there to the local store and purchase OTC health benefits that may be provided to was an absence of good data on the epinephrine MDI. Wyeth presented data this population by having epinephrine safety and efficacy of OTC epinephrine from a survey they had conducted MDIs available OTC. Any final MDIs. Her opinions were shared by indicating that one-third of OTC conclusion we reach on the essential- many members of the committees. epinephrine MDI users use it as their use designation of epinephrine could be NDAC/PADAC members who sole asthma medication, while two- affected by data on the public-health recommended that the essential use for thirds use it in addition to prescription benefit contained in comments OTC epinephrine MDIs be retained did drugs. The survey indicated that 55 submitted in response to this proposed not state that epinephrine was safer or percent of people with asthma who rule. more effective than albuterol. The solely use OTC epinephrine MDIs for Wyeth presented information at the evidence before us indicates that their asthma said that the OTC product NDAC/PADAC meeting from their 2005 epinephrine is not safer or more is ‘‘easier and quicker to obtain.’’ Fifty- survey indicating that 22 percent of effective than albuterol. The EPR–2 eight percent of asthma patients who people with asthma did not have health recommends against epinephrine’s use. use both prescription drugs and OTC insurance (Wyeth slide 31). Statistics The consensus opinion at the NDAC/ epinephrine MDIs say they purchase the from NCHS (Ref. 10) indicate that PADAC meeting was that OTC OTC MDI when they either ‘‘run out of slightly less than 14.1 percent of the epinephrine MDIs presented no my prescription medication’’ or ‘‘have general population does not have health significant therapeutic advantage over an asthma attack and I don’t have my insurance. While the difference between albuterol MDIs. This leads us to prescription with me’’ (Wyeth slide 36). 14.1 percent and 22 percent is not tentatively conclude that OTC Maintaining current valid significant for purposes of this prescriptions and supplies of prescribed epinephrine MDIs do not provide a document,22 it may be true that the drugs is a regular and sometimes clinical benefit that is otherwise percentage of people with asthma who onerous, but necessary, task for many unavailable. If we intended to draw a are uninsured is higher than that of the patients with chronic diseases. It would conclusion about the public health general population. Wyeth also certainly be more convenient for all of presented data indicating that 27 20 these patients if some sort of therapeutic EPR–2 was updated in 2002 (Ref. 6) (EPR— percent of people with asthma do not alternative were available OTC. Update 2002). References to outside publications or have health insurance that provides any other statements of fact or opinion in this However, there are no OTC remedies for prescription drug benefits (Wyeth slide document concerning a drug product are not most serious diseases. Of note, patients intended to be equivalent to statements in labeling approved under section 505 of the act (21 U.S.C. with anaphylaxis to bee stings or 22The reason we say that the difference is not 355) and part 314 of FDA regulations (21 CFR part peanuts can face sudden, life- significant for purposes of this document is that so 314). threatening attacks if exposed to their many of the numbers discussed represent such 21The EPR–2 is very similar to other published relevant triggers. Yet epinephrine broad estimates that the difference between 14 standards of care (See the Australian Asthma percent and 22 percent would not affect any Management Handbook: 2002 (Ref. 7) and the autoinjectors, such as EPIPEN, are not conclusion. We are acutely aware that for the ‘‘Canadian Asthma Consensus Report, 1999’’ (Ref. OTC products because of considerations individuals and families involved, absence of 8). that include the proper evaluation and health insurance is very significant.

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31). However, lack of insurance does not There is very little data about how apparently have adequate access to necessarily equate to poverty and barriers to health care affect use of OTC health care, we will focus, for this part financial barriers to adequate health epinephrine MDIs. According to data of the document, on the one-third of care. Approximately 18 percent of provided by Wyeth, roughly two-thirds OTC epinephrine MDI users who solely uninsured Americans have household of OTC epinephrine MDI users use the use OTC epinephrine MDIs. We have incomes of $75,000 or more, and MDIs in addition to prescription drugs, very little data on why patients use OTC another 17 percent have household while one-third solely use OTC epinephrine MDIs instead of prescribed incomes of $50,000 to $74,999 (Ref. 11). epinephrine MDIs (Wyeth slide 32). As drugs. At the NDAC/PADAC meeting Other barriers to health care exist, discussed in section V.B.2.b of this Wyeth presented data from their 2005 such as lack of sick leave, document, a majority of the two-thirds Internet survey of people with asthma transportation, and child care. However, of OTC epinephrine MDI users who also (Wyeth slide 35). The data are we do not have any data that would be use prescription drugs do so for reasons useful in determining how these barriers of convenience. However, because the summarized in table 1 as follows: affect people with asthma and their use two-thirds of OTC epinephrine MDI of OTC epinephrine MDIs. users who also use prescription drugs

TABLE 1.—MOST FREQUENT REASONS CITED BY SOLE OTC EPINEPHRINE MDI USERS

‘‘Easier and quicker to obtain’’ 55 percent

‘‘More reasonably priced’’ 41 percent

‘‘I don’t have health insurance’’ 25 percent

‘‘I don’t want to go to a doctor’’ 25 percent

‘‘I don’t have a doctor’’ 21 percent

‘‘OTC drugs work better for me’’ 11 percent

The basis for the ‘‘more reasonably don’t have health insurance’’ (25 health care. However, any priced’’ response in the survey is percent), ‘‘I don’t want to go to a doctor’’ underestimation may be unclear. While the perception of a (25 percent), and ‘‘I don’t have a doctor’’ counterbalanced by other factors, such percentage of the survey participants (21 percent). Those stating absence of as: may have been that OTC epinephrine health insurance are describing a • Approximately 18 percent of was less costly, an accurate potential barrier to health care. The uninsured Americans have household determination of the relative price of the other two statements are more incomes of $75,000 or more, and OTC product compared to the ambiguous. ‘‘I don’t want to go to a another 17 percent have household prescription substitutes would require a doctor’’ may be an expression of a incomes of $50,000 to $74,999 (Ref. 11). complex analysis which could not be general aversion to going to doctors, it While uninsured, these people would embodied in an informal Internet may be a manifestation of a desire not not necessarily face barriers to health opinion survey. For example, it is not to confront a potentially serious illness, care. clear how respondents calculated the or it also may reflect that an asthmatic • According to Wyeth’s 2005 Internet retail price of the prescription drug may not wish to go to a doctor because survey, 28 percent of people with products that they compared to OTC of lack of insurance or other barriers to asthma who solely use OTC epinephrine epinephrine, if they were comparing health care. ‘‘I don’t have a doctor,’’ may MDIs have visited a doctor in the comparable drug products, or the degree be similar to ‘‘I don’t want to go to a previous year for treatment of asthma; to which they factored health insurance doctor,’’ or it may reflect a person who these patients presumably have access co-payments or the availability of has not yet chosen a doctor, because of to health care. patient assistance programs into their a recent arrival in a locality or because We do not know how these two points price comparison. It is also unclear if the person has stopped seeing a relate to the numbers from Wyeth’s 2005 the respondents viewed the cost of a previous doctor. Internet survey giving the reasons that visit to a physician to obtain a The survey participants were people with asthma purchase OTC prescription as a part of the price of a permitted to select more than one epinephrine MDIs. As was frequently prescription drug. Because it is not clear reason for solely using an OTC noted at the NDAC/PADAC meeting, the what this response actually means, it epinephrine MDI. While we know that debate over the essential-use status of contributes little to our analysis of the participants gave more than one answer epinephrine is hobbled by a paucity of possible public health benefits of (the sum of the answers is 178 percent), data, and we note here that we are epinephrine. we do not know how the responses especially interested in receiving public As discussed at length at the NDAC/ overlapped with each other. We will comments and any available data PADAC meeting, the response in the assume, for now, that the 25 percent concerning this issue. The fact that this survey that ‘‘OTC drugs work better for responding ‘‘I don’t have health is an Internet survey, and that we know my asthma’’ is not supported by insurance’’ represents users of OTC little about how the survey was adequate and well-controlled studies. epinephrine who do so because of conducted, raises questions about its The responses that may best inform barriers to health care. We realize that reliability. However, in the absence of an attempt to reach a low-end estimate this may underrepresent those people better data, we estimate that 25 percent of the percentage of people who solely with asthma whose responses of ‘‘I don’t of people with asthma who solely use use OTC epinephrine MDIs who do so want to go to a doctor,’’ and ‘‘I don’t OTC epinephrine MDIs for treatment of because of barriers to health care are ‘‘I have a doctor’’ also reflected a barrier to asthma do so because of barriers to

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health care. Since two-thirds of people estimate that between 9 percent and 14 counseling in community health centers who use OTC epinephrine MDIs also percent of all people with asthma who (Ref. 13, p. 135) and hospital admissions use prescription drugs to treat their use OTC epinephrine MDIs do so for pediatric asthma (Ref. 13, p. 150). asthma, somewhat less than 9 percent of because of barriers to health care to our None of the data in the 2005 NHDCR all people with asthma using OTC estimate that 1.7 to 2.3 million people refer directly to the use of OTC epinephrine MDIs do so because of with asthma use OTC epinephrine epinephrine MDIs, so drawing specific barriers to health care. These figures MDIs, we arrive at an estimate that conclusions from the 2005 NHCDR is appear to be the best low-end estimate between 150,000 and 320,000 people difficult and subjective. we can derive from the limited data we with asthma who use OTC epinephrine Results from the National Cooperative have before us. Referring to their 2005 MDIs do so because of barriers to health Inner City Asthma Study (NCICAS) Internet survey, Wyeth stated that 60 care. At the NDAC/PADAC meeting, a were referred to at the NDAC/PADAC percent of people with asthma solely representative for several Hispanic- meeting. NCICAS was sponsored by the using OTC epinephrine MDIs replied American health policy organizations National Institute of Allergy and that they had a ‘‘prescription presented information about the high Infectious Diseases (NIAID). NCICAS medication coverage plan’’ (Wyeth slide incidence of asthma among Hispanic- studied a treatment strategy for children 33). This figure is lower than the 66 Americans and African-Americans with asthma living in inner-city census percent who replied that they had (meeting transcript, pp. 162 to 169). The tracts where at least 20 percent of the insurance covering physicians visits. representative opposed removing population was below federal poverty This means that approximately 40 epinephrine’s essential-use designation, guidelines. The study was conducted in percent of OTC epinephrine MDI users stating that it would have a serious eight study units located in seven cities who solely use the product did not have adverse impact on people with asthma across the United States. Wyeth prescription drug coverage. This seems who face barriers to health care, and presented information from a report a reasonable high-end estimate of the that this impact would be from NCICAS, showing that 53 percent percentage of people with asthma solely disproportionately felt by Hispanic- of the participants in the study reported using OTC epinephrine MDIs who do so Americans. difficulties in obtaining short term care because of barriers to health care. This According to the 2002 NHIS (Ref. 12), for their children’s asthma (Ref. 14). estimate is over-inclusive because it 7.2 percent of Non-Hispanic Whites in Ninety-three percent of the families includes people with asthma whose the United States had asthma, while the studied in NCICAS were insured, income would mean that absence of prevalence of asthma in Non-Hispanic largely by Medicaid, and while 50 insurance does not present a barrier to Blacks was 9.5 percent and the percent of the families studied had to health care and patients with asthma corresponding figure for Non-Hispanic pay for health care (presumably a co- that have access to free or low-priced American Indians was 9.9 percent. The payment for most of the families), only drugs through doctor’s samples or free incidence of asthma among all 8 percent reported ‘‘care costs too and low-priced drug programs. The fact Hispanics in the United States (4.9 much’’ as a barrier to health care. The that lack of insurance coverage for percent) was lower than the incidence intervention studied in the NCICAS was prescription drugs does not perfectly for the general population (7.2 percent), described as effective by one of the lead reflect barriers to health care is shown but the rate for Puerto Ricans was investigators (Ref. 15). Failure to refill by the fact, according to Wyeth’s 2005 markedly higher at 13.1 percent. prescriptions for asthma drugs was survey, that 19 percent of asthma The National Health Care Disparities mentioned by Wyeth at the NDAC/ patients who solely use prescription Report (Ref. 13) (2005 NHCDR) (which PADAC meeting (meeting transcript, p. drugs do not have insurance coverage was mentioned by the speaker), 113). Another report from NCICAS for prescription drugs. While it is over- indicates that Hispanic-Americans have shows that 16 percent of caregivers inclusive for some groups, the higher significantly worse access to health care reported not having a prescription filled figure may do a better job of capturing in terms of numbers of uninsured for the child with asthma for whom they people who face other poorly quantified persons (Ref. 13, p. 92) having a usual were caring (Ref. 16). This number barriers to health care, such as lack of source of care (a facility where one compares favorably with compliance sick leave, transportation, or child care. regularly receives care) (Ref. 13, p. 94), rates found in the general population.24 We have arrived at an estimate that and having a usual primary care People do not always have prescriptions between 25 percent and 40 percent of provider (a doctor or nurse from whom filled or take their medicine, regardless people with asthma who solely use OTC one regularly receives care) (Ref. 13, p. of income or health insurance. epinephrine MDIs, and therefore 95). Other portions of the 2005 NHCDR Dr. Carolyn Kercsmar, who between 9 percent and 14 percent of all provide information about asthma participated in the NCICAS and is a people with asthma that use OTC member of PADAC, responded to epinephrine MDIs, do so because of look at the 1993 ACNielsen study (Wyeth slide 29) Wyeth’s description of the data from the where the study population was adults, it appears barriers to health care. We have also that Wyeth compared the number of respondents NCICAS by saying, ‘‘* * *[the children estimated that 1.7 to 2.3 million people who reported using an OTC asthma drug (557) to with asthma and the caregiver’s] access with asthma use OTC epinephrine the number of respondents who reported having an were problems and didn’t prevent them, MDIs. This estimate is based on data asthma incident in the previous 12 months (2,713). If we divide 557 by 2,713, we get 0.205 or 20 it just hindered their care, and it was provided by Wyeth at the NDAC/ percent. The number of adults who have asthma is not just for acute care. It was for PADAC meeting, although Wyeth substantially higher than the number who have had problems in accessing chronic care. reached a different conclusion based on an asthma incident in the previous 12 months; for Also, in that study, the vast majority of 23 2004 the numbers are 14.4 million and 7.7 million the same numbers. Applying our respectively (Ref. 35). Applying 15 to 20 percent to the patients had medication prescribed the number of adults with asthma would result in including albuterol as part of that 23At the NDAC/PADAC meeting Wyeth presented a significant inflation of the number of OTC study.* * *’’ (meeting transcript, p. estimates that 15 to 20 percent of adults with epinephrine MDI users. Applying 15 to 20 percent asthma use OTC epinephrine (Wyeth slide 32). to the number of adults who have had an asthma 141). Applying these percentages to the number of adults incident in the previous 12 months gives us an who have asthma, they estimated that 2 to 3 million estimate of 1.7 to 2.3 million people using OTC 24See Refs. 17 and 18. The various studies used people use OTC epinephrine MDIs at any given epinephrine MDIs. We believe that this estimate is different methods of measuring non-compliance, so time. Wyeth appears to have made a mistake. If we more accurate than the 2 to 3 million estimate. direct numeric comparisons are not possible.

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The NCICAS data do not show that not release ODSs) means that, while surveyed who solely use OTC the availability of OTC epinephrine is these drug are more expensive per MDI epinephrine MDI stated that they had needed for adequate treatment of asthma and per dose, they may be cheaper than been diagnosed with asthma by a doctor in poor inner-city areas. While OTC epinephrine MDIs when the price (Wyeth slide 23, citing Ref. 20). We do recognizing that the patient population is calculated for each hour of relief not have data on how recently the studied was largely insured, we believe (meeting transcript, pp. 159–160). While diagnoses were made or on the current that comparable health care access a drug’s duration of action can affect the accuracy of the diagnoses. The study options for low-income, non-insured cost to a patient (or other payor) for did state that only 47 percent of those patients are widely available. Programs therapy with the drug, we do not have who solely use OTC epinephrine MDIs that offer free or low-cost drugs, such as the comparative clinical data to confirm currently had a primary caregiver for Schering’s ‘‘SP Cares program’’ (see the assertion made by the speaker. management of asthma (Ref. 20, p. 989), www.schering-plough.com/ We believe that a small population of which would seem to indicate that at schering_plough/corp/sp_cares.jsp), and people with asthma who face barriers to least some of the diagnoses were not organizations that provide more health care may derive some benefit particularly recent. The Internet survey comprehensive health care free or at from having epinephrine MDIs available presented by Wyeth at the NDAC/ low-cost, such as Communicare in OTC. We also believe that utilization of PADAC meeting indicates that 8 percent South Carolina or the Puget Sound programs providing low-cost or free of purchasers of OTC epinephrine MDIs Neighborhood Health Centers in prescription drugs may reduce, but not have not been diagnosed with asthma by Washington, should be able to help eliminate, the number of people with a physician, and 28 percent of those lower economic barriers to access for asthma facing barriers to health care who solely use OTC epinephrine MDI people with asthma who use OTC who depend on OTC epinephrine MDIs. reported that they visited a doctor’s epinephrine MDIs. Although we do not We are keenly interested in, and request office in the past year for treatment of believe that all of the people currently comments on, the public health effect their asthma (Wyeth slide 33). This using OTC epinephrine MDIs due to and costs that may result from the would imply that 72 percent of people economic barriers to health care can or removal of OTC epinephrine MDIs from who solely use OTC epinephrine MDI will avail themselves of these programs, the market and how these programs may had not seen a doctor in the past year we do believe that these programs are reduce any adverse impact on the public for diagnosis and treatment of their widely available, and that they can health. We will take under asthma. provide adequate alternatives to OTC consideration and weigh carefully the Asthma is a variable disease that can epinephrine MDIs for many people with potential consequences identified in either lessen or worsen in severity over asthma. This should minimize some of public comments before issuing any time. A person previously diagnosed the adverse impacts that may result final rule. In assessing the public health with asthma may be asymptomatic for from the absence of OTC epinephrine benefits of OTC epinephrine MDIs, the long periods of time. A diagnosis of MDIs. benefits of having the drug available asthma and, more important, an In looking at the issue of OTC OTC must be balanced against the evaluation of its severity made at some epinephrine MDIs as an alternative for potential risks, if any. point in the past may no longer be people with asthma who face barriers to c. Do risks of self-treatment of asthma accurate. Currently, follow-up visits are health care, it should be kept in mind outweigh the public health benefits that recommended at 1- to 6-month intervals that the retail price of OTC epinephrine OTC epinephrine MDIs may provide? after an initial diagnosis of asthma MDIs is also a barrier to health care. In Much of the discussion at the NDAC/ (EPR–2, Ref. 5, p. 87). A previous comparing the price of OTC epinephrine PADAC meeting focused on the issue of diagnosis of asthma does not necessarily to that of its alternatives, we must keep whether the risks of self-treatment of mean that an individual’s current in mind that OTC epinephrine MDIs, asthma outweigh the public health asthma-like symptoms are caused by which cost approximately $13 per benefits that OTC epinephrine MDIs asthma, or that the individual’s asthma inhaler (meeting transcript, p. 127), are may provide. This issue could affect any is of the same severity as originally not available through any low-cost drug decision we make on the essential-use diagnosed. The likelihood of the plans. Prescription drugs obtained status of OTC epinephrine MDIs. previous diagnosis accurately reflecting through these programs can be Accordingly, we will discuss some of the patient’s current status would substantially less expensive than OTC the points raised at the NDAC/PADAC seemingly have to decrease the older the epinephrine MDIs. To give one example, meeting and other information we feel diagnosis and evaluation is. A study an eligible person obtaining VENTOLIN may be relevant, and request comment referred to by Wyeth at the NDAC/ HFA (albuterol MDI) through GSK’s on these issues to the extent that they PADAC meeting said that ‘‘self ‘‘Bridges to Access’’ program would apply to OTC epinephrine MDIs as an assessment of asthma severity may not make a $10 co-payment for a 60-day essential use of ODSs. be ‘on target,’ especially among supply of the drug; after 60 days no i. Misdiagnosis of asthma. OTC individuals who self-medicate their further co-payment is required (see epinephrine MDIs are only indicated for illness with nonprescription http://bridgestoaccess.gsk.com/ mild intermittent asthma. The approved bronchodilators’’ (Ref. 20, p. 992). It index.html). OTC epinephrine MDIs are labeling for OTC epinephrine MDIs should be kept in mind that this was more expensive than prescription drugs states that the drug should only be used said about a group in which 92 percent for people who can and do avail after a doctor has diagnosed asthma. had reported having been diagnosed by themselves of low-cost drug programs This is because asthma can be a difficult a physician as having asthma. This such as ‘‘SP Cares’’ and ‘‘Bridges to disease to diagnose, even for physicians study was relatively small and, while Access.’’ (Ref. 19). COPD, vocal chord potentially informative, it cannot be A public speaker representing an dysfunction, heart disease, and many viewed as conclusive at this time. asthma education and advocacy other illnesses can be misdiagnosed as There are some additional data organization before the NDAC/PADAC asthma (see Ref. 5, p. 22). available on the potential misdiagnosis meeting said that the longer duration of The results of a study presented by of the severity of asthma by purchasers effect of albuterol and levalbuterol (and Wyeth at the NDAC/PADAC meeting of OTC epinephrine MDIs. Wyeth other newer prescription drugs that do indicated that 92 percent of those presented data at the NDAC/PADAC

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meeting that 76 percent of OTC The issue of the accuracy of the short-acting inhaled beta2-agonist epinephrine MDI purchasers bought one diagnosis of asthma upon which a bronchodilator and albuterol MDIs are or two OTC epinephrine MDIs a year. purchase of an OTC epinephrine MDI is the most widely prescribed ‘‘rescue This indicates that 24 percent of made is very important in reaching a inhalers’’ in the United States. The purchasers bought three or more OTC determination on the public health EPR–2 does not recommend epinephrine MDIs each year. A Wyeth benefits of having the drug available nonselective short-acting beta-agonist web page (http://www.primatene.com/ OTC. While some evidence suggests that bronchodilators as rescue inhalers, but faq/answers.asp#puffs) says that each many purchasers of OTC epinephrine rather they recommend use of an 15 milliliters (mL) vial should deliver MDIs are doing so based on an inhaled short-acting beta2 selective 270 puffs and the 22.5 mL of inaccurate diagnosis of the severity of agonist. Beta-receptors are adrenergic PRIMATENE MIST vial should deliver their asthma, we have not reached a sites in the autonomic nervous system 405 puffs. The 15 ml vial is the most conclusion on that evidence’s weight in which physiological responses occur popular size of PRIMATENE MIST and significance. when agents, in this case beta-agonists, (meeting transcript, p. 127). The 15 mL ii. Undertreatment of asthma. are bound to the receptor. Activation of size is also the size manufactured for Undertreatment of asthma can cause beta-receptors causes various reactions, sale as house brands by Armstrong. If more frequent symptoms and attacks, including relaxation of the bronchial we look at three 15 mL MDIs used over missed work and school, activity muscles and an increase in the rate and a year-long period, we see that they limitations, a decline in lung health and force of cardiac contraction. The beta- would provide 16 puffs a week, a level function and, possibly, death (Ref. 9). receptors are subdivided into beta1, of use that would indicate asthma As mentioned earlier, in the United located primarily in the heart and incidents that are so frequent or severe States, the generally recognized intestinal smooth muscle, and beta2, that it no longer should be characterized standard of care for asthma is set forth more localized to bronchial, vascular, mild intermittent asthma. We realize in the EPR–2 (Ref. 5). In the 2002 update and uterine smooth muscles. that some of the 24 percent of people to EPR–2 (Ref. 6) we find the latest Epinephrine is a non-selective beta- who solely use OTC epinephrine MDIs updates to the standard. Asthma is agonist which affects both the beta1 and and purchase three or more MDIs in a divided into four classes of severity, beta2-receptors so that it affects both year may not be using all of the contents which correspond to treatment ‘‘steps.’’ heart and bronchial smooth muscles (as of the OTC epinephrine MDIs they More severe classes of asthma are well as the intestinal, vascular, and purchase. They may be replacing lost defined by greater frequency of uterine smooth muscles). Beta2 selective MDIs or purchasing extra MDIs to keep symptoms during the day and night, agonists, such as albuterol, have less of lower peak expiratory flow (PEF) and at work or in a gym bag. It also should an effect on the heart than beta1 and forced expiratory volume in 1 second be noted that the use of two 22.5 mL non-selective beta-agonists have. (FEV1) (both are measurements of how vials a year also provides 16 puffs a Epinephrine’s lack of selectivity has well a patient can exhale using the week, again indicating a level of use that caused concerns about its effect on the greatest effort), and higher variability in would not be associated with mild heart, but the limited data we have PEF measurements over the course of a intermittent asthma. before us do not indicate that use of day. OTC epinephrine MDIs is associated There is other evidence that As the severity of a patient’s asthma with a greater risk of significant adverse purchasers of OTC bronchodilators were increases, treatment becomes more cardiovascular events. unable to correctly diagnose the severity aggressive: For mild persistent asthma, The question of undertreatment of of their asthma. A study was conducted daily use of an inhaled corticosteroid asthma for purchasers of OTC in Australia of purchasers of albuterol (available only by prescription) is epinephrine MDIs is not confined to (or salbutamol, as it is known in recommended; if the patient has people with asthma who solely or Australia and most of the rest of the moderate persistent asthma, higher primarily use OTC epinephrine MDIs. world), a bronchodilator that was doses of inhaled corticosteroids and/or The level of usage of short-acting beta2- available both with and without a inhaled corticosteroids with a long- agonists is a factor that should be prescription in the State of New South acting beta-agonist are recommended; monitored by physicians treating Wales (Ref. 21). In that study, 95 percent and for severe persistent asthma, still asthma patients (EPR–2, Ref. 6, p. 35). of the surveyed purchasers who usually higher doses of inhaled corticosteroids Increased usage may often indicate the or always purchased albuterol without a are recommended in conjunction with a need for treatment being stepped up, prescription were undertreated for their long-acting bronchodilator (available while decreased usage may indicate that asthma according to a relevant standard only by prescription). treatment could be stepped down. The of care. We have not formed an opinion If a patient’s asthma becomes more availability of OTC epinephrine MDIs on the applicability of the study to the severe, treatment should become more allows patients to purchase a short- questions involved in this rulemaking. aggressive, and if the asthma is well acting beta-agonist without a We realize that the study involved a controlled, a physician should generally prescription. It seems possible that this different drug (albuterol), in a different try to reduce the quantity of drugs being may deny important information to the country (Australia), and that the study taken in order to provide good control health care provider as to the accurate is over 13 years old. However, we also with the minimum quantity of drugs. assessment of a patient’s use of rescue recognize that the study may represent This approach is characterized as a inhalers. We are unaware of any data some of the better data currently ‘‘stepwise approach for managing that directly address this issue. available on the question of self- asthma’’ (EPR 2002 Update, Ref. 6, iii. Patient education. Patient diagnosis of asthma by the purchasers of Appendix A–1). education is generally regarded as a key OTC bronchodilators. No daily medication is recommended component to successful asthma The evidence seems to suggest that for mild intermittent asthma, but the treatment. The EPR–2 says, ‘‘[E]ducation many OTC epinephrine MDI purchasers EPR–2 recommends the use of a short- for an active partnership with patients are buying the drug based either on self- acting inhaled beta2-agonist remains the cornerstone of asthma diagnosis or on an out-of-date bronchodilator, as needed to treat the management and should be carried out physician’s diagnosis. occasional bronchospasm. Albuterol is a by health care providers delivering

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asthma care. Education should start at corticosteroids as a control medication, C. Does Use of OTC Epinephrine MDIs the time of asthma diagnosis and be may not be as effective for these patients Release Cumulatively Significant integrated into every step of clinical as might otherwise be possible. The Amounts of ODSs Into the Atmosphere asthma care’’ (Ref. 5, p. 5). effects of undertreatment of asthma may or is the Release Warranted in View Of Elements of patient education can be a key issue in any discussion of the The Otherwise Unavailable Important include providing information about risks and benefits of self-treatment of Public Health Benefit? how asthma affects the lungs, the asthma. The use of CFCs in MDIs for the difference between short-acting rescue treatment of asthma and COPD is the medications and control medications, One public speaker did say that ‘‘a only legal use in the United States of the importance of using control delay in the early introduction of medication as prescribed, important prescription anti-inflammatory asthma newly manufactured CFCs. The quantity environmental control measures that therapy could lead to the development of CFCs used in OTC epinephrine MDIs may need to be considered, such as of irreversible lung damage’’ (meeting is a significant portion of the total removing asthma triggers from the transcript, p. 171). We do not find his quantity of newly manufactured CFCs patient’s home, the tracking of severity statement to be persuasive. The use of used, and therefore eventually released, in the United States. The size of the of the patient’s asthma, and proper use inhaled steroids was not shown to portion will increase as other MDIs of an MDI. prevent damage to the lungs in several containing CFCs are removed from the The proper use of an MDI is an studies (Refs. 29, 30, and 31), and the important factor in proper treatment of market. As we discussed in part II of evidence supporting the speaker’s this document, the release of CFCs from asthma. This issue was mentioned but statement about ‘‘irreversible lung not discussed at the NDAC/PADAC MDIs is cumulatively significant. damage’’ is limited and not conclusive Because we have not reached a meeting (meeting transcript, p. 139). (Ref. 32). Any disagreement on the issue Improper use of an MDI can result in a conclusion on the public health benefits of permanent lung damage should not reduction of the dose delivery by 50 of OTC epinephrine MDIs, we cannot be allowed to obscure the fact that percent or more (Ref. 22). A study in reach a conclusion on whether the children and adolescents showed less proper use of inhaled steroids release of CFC ODSs is warranted in than 25 percent used their MDIs significantly reduces asthma morbidity. view of the public health benefits. correctly (Ref. 23), and a study in adults 3. Conclusions on the Public Health D. Conclusions showed similar results (Ref. 24). Benefits of OTC Epinephrine MDIs Further, the last study showed that We have tentatively concluded the inadequate English language literacy is following: We believe that epinephrine does not • associated with poor use of MDIs. have any clinical advantages over The pharmaceutical industry has The importance of patient education albuterol HFA MDIs and that patient had success in formulating similar moieties without ODSs. In particular, may be a significant issue in any convenience for patients that have not HFA MDIs containing albuterol, a close discussion of the risks and benefits of kept their asthma drugs prescriptions chemical analog of epinephrine, have self-treatment of asthma. current or do not have the prescribed iv. Effects of undertreatment. While been approved by FDA. We have no drug product with them is not an the cost of treatment for poor and evidence to suggest that formulating important public health benefit. We medically underserved populations was epinephrine in a product that does not have not reached a conclusion on the frequently mentioned at the NDAC/ release ODSs poses unique technical PADAC meeting, much less was said risks and benefits of continuing to have challenges. Therefore, we tentatively about the effects and costs of epinephrine available OTC for people conclude that no substantial technical undertreatment. A recent study of urban with asthma who face barriers to barriers exist to formulating an pediatric patients, who were obtaining appropriate health care, and epinephrine inhaler without ODSs. predominantly from poor and minority therefore we cannot reach a conclusion • The release of ODSs into the households, showed that an increased on whether the use of OTC epinephrine atmosphere from OTC epinephrine use of corticosteroids in pediatric MDIs provides an important health MDIs is cumulatively significant. patients (in accordance with the benefit. We specifically request We have not reached a conclusion on guidelines in EPR–2) resulted in fewer comments on the expected costs and whether the use of OTC epinephrine hospitalizations, emergency department public health effects to individuals with MDIs provides an unavailable important visits, and outpatient visits (Ref. 25). asthma if OTC epinephrine MDIs were public health benefit or whether the The importance of prompt removed from the market without a release of ODSs from OTC epinephrine appropriate treatment of asthma is similar product being available OTC. MDIs is warranted in view of the reinforced by studies suggesting that While our tentative conclusion that otherwise unavailable public health delaying treatment with inhaled epinephrine is no longer an essential benefit. However, as we discussed in corticosteroids decreases the use is based primarily on the conclusion part II of this document, if a use fails to effectiveness of the inhaled we have drawn regarding technical meet any one of the three criteria in corticosteroids once treatment begins barriers to producing the epinephrine in § 2.125(f), FDA may elect to go through rulemaking to remove its essential-use (Refs. 26 and 27). a non-ODS formulation, we will Studies also indicate that regular use designation. evaluate the public-health effects of of beta-agonist bronchodilators may We have therefore tentatively removal of OTC epinephrine from the reduce the person with asthma’s concluded that oral pressurized MDIs response to subsequent beta-agonist market, and any final conclusions we containing epinephrine are no longer an administration (Ref. 28). This tolerance reach on the essential-use designation of essential use of ODSs and should be could mean that patients who regularly epinephrine may be significantly removed from the list of essential uses use OTC epinephrine MDIs may be influenced by data received in in § 2.125(e). As noted throughout the placed in a position where their comments on the public-health issues preamble, we are keenly interested in occasional use of a beta2-agonist, as part raised by this proposal. receiving public comments and any of a course of treatment using inhaled available data concerning technical

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barriers to developing an epinephrine and other advantages; distributive MDIs choose to self-medicate, they will inhaler without ODSs, the status of any impacts; and equity). The agency be more likely to require hospitalization ongoing efforts to develop such a believes that this proposed rule is a or an emergency department visit. product, and the public health effects significant regulatory action as defined Alternatively, if they choose to see a and costs of removing epinephrine MDIs by the Executive order. physician to obtain a prescription for from the market prior to a similar The Regulatory Flexibility Act albuterol, the OTC epinephrine CFC product being available OTC. Any final requires agencies to analyze regulatory MDI users, or their insurers, will have conclusions that we reach on the options that would minimize any to pay more, not only for visits to the essential-use designation of epinephrine significant impact of a rule on small physician, but also for more expensive may be significantly influenced by such entities. The agency does not believe drugs. More physician visits, however, comments. that the proposed rule would have a may lead current OTC epinephrine MDI significant economic impact on a VI. Environmental Impact users to increase their use of substantial number of small entities. prescription control medication, such as We have carefully considered the Section 202(a) of the Unfunded inhaled corticosteroids, which should potential environmental effects of this Mandates Reform Act of 1995 requires decrease their likelihood of both asthma action. We have tentatively concluded that agencies prepare a written attacks and hospital visits. We have no that the action will not have a statement, which includes an data suggesting whether current OTC significant adverse impact on the assessment of anticipated costs and epinephrine MDI users are more likely human environment, and that an benefits, before proposing ‘‘any rule that to self-medicate or to visit a physician environmental impact statement is not includes any Federal mandate that may and get an albuterol MDI prescription required. Our initial finding of no result in the expenditure by State, local, once OTC epinephrine MDIs are no and tribal governments, in the aggregate, significant impact and the evidence longer available. We therefore focus on or by the private sector, of $100,000,000 supporting that finding, contained in a scenarios where, if OTC epinephrine or more (adjusted annually for inflation) draft environmental assessment, may be MDIs are no longer available, all current in any one year.’’ The current threshold seen in the Division of Dockets OTC epinephrine MDI users either self- after adjustment for inflation is $122 Management (see ADDRESSES) between 9 medicate with other products such as million, using the most current (2005) a.m. and 4 p.m., Monday through herbal supplements, caffeine, and OTC Implicit Price Deflator for the Gross Friday. We invite comments on the draft ephedrine or visit a physician to obtain, Domestic Product. This proposed rule environmental assessment. Comments and fill, prescriptions for albuterol may result in a 1-year expenditure that on the draft environmental assessment MDIs. These extreme scenarios offer may be submitted in the same way as would meet or exceed this amount. The Congressional Review Act plausible bounds for estimating the comments on this document (see requires that regulations that have been costs and benefits resulting from this DATES). identified as being major must be proposed rule and regulatory VII. Analysis of Impacts submitted to Congress before taking alternatives. effect. This rule is major under the CFCs available for production of OTC A. Introduction Congressional Review Act. epinephrine MDIs may be exhausted FDA has examined the impacts of the This proposed rule would prohibit prior to the effective date of this proposed rule under Executive Order sales of OTC epinephrine CFC MDIs in proposed rule if the United States was 12866 the Regulatory Flexibility Act (5 interstate commerce after December 31, unable to obtain an essential-use U.S.C. 601–612), and the Unfunded 2010, forcing users to either self- allocation for CFCs under the Montreal Mandates Reform Act of 1995 (Public medicate with less effective therapies Protocol for use in OTC epinephrine Law No. 104–4). Executive Order 12866 (see section VII.D.3.a), or to visit a MDIs for 2010 (see Ref. 33, p. 59). If so, directs agencies to assess all costs and physician and get a prescription for an this proposed rule may not have any benefits of available regulatory alternative drug product such as significant impacts. To the extent that alternatives and, when regulation is albuterol. Because OTC epinephrine CFCs for production of OTC necessary, to select regulatory CFC MDIs are widely regarded by epinephrine MDIs remain available, we approaches that maximize net benefits physicians and people with asthma as estimate this proposed rule will have (including potential economic, the most effective relief medication for the impacts summarized in the environmental, public health and safety, asthma available OTC, if users of these following table.

TABLE 2.—SUMMARY OF ANNUAL QUANTIFIABLE EFFECTS OF THE PROPOSED RULE, ASSUMING CFCS FOR PRODUCTION OF OTC EPINEPHRINE MDIS REMAIN AVAILABLE

Increased Increased Health Emergency Increased Reduced CFC care Expenditure, Department Hospitalizationsfor Emissions in 2006 Dollars Visits for Asthma from Phase- Asthma Out (tonnes)

If current OTC epinephrine MDI users self-medicate $360 million to 0 to 40,000 to 120,000 70 $1.0 billion 440,000

If current OTC epinephrine MDI users visit their physician for pre- scription albuterol (excluding controller medication) $170 million to 70 $340 million

We are unable to estimate cancers, cataracts, and environmental in CFC emissions by roughly 70 tonnes quantitatively the reductions in skin harm that may result from the reduction during these years. Although we cannot

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estimate quantitatively the public health use designation for ODSs used in MDIs agree to designate the use for which the effects of the phase-out, based on a containing epinephrine because we CFCs are produced as ‘‘essential’’ and qualitative assessment, the agency have tentatively concluded that no approve a quantity for that use. concludes that the benefits of this substantial technical barriers exist to Each year, each Party nominates the regulation justify its costs. formulating epinephrine in a product amount of CFCs needed for each We state the need for the regulation that does not release ODSs (see section essential use and provides the reason and its objective in section VII.B of this V.A of this document). Removing this such use is essential. Agreement on both document. Section VII.C of this essential-use designation will reduce the essentiality and the amount of CFCs document provides background on CFC emissions that deplete stratospheric needed for each nominated use has been depletion of stratospheric ozone, the ozone. reached by consensus at the annual Montreal Protocol, the OTC epinephrine Meeting of the Parties. MDI market, and the health conditions C. Background that epinephrine is used to treat. We 1. CFCs and Stratospheric Ozone 3. Benefits of the Montreal Protocol analyze the benefits and costs of the During the 1970s, scientists became EPA has generated a series of rule, including effects on government estimates of the environmental and outlays, in section VII.D of this aware of a relationship between the level of stratospheric ozone and public health benefits of the Montreal document. We assess alternative dates Protocol (Ref. 35). The benefits include industrial use of CFCs. Ozone (O3), in section VII.E of this document, and reductions of hundreds of millions of discuss sensitivity analysis in section which causes respiratory problems when it occurs in elevated nonfatal skin cancers, 6 million fewer VII.F of this document. We present an fatalities due to skin cancer, and 27.5 analysis of the effects on small business concentrations near the ground, shields the Earth from potentially harmful solar million cataracts avoided between 1990 in a regulatory flexibility analysis in and 2165 if the Montreal Protocol were section VIII of this document. We radiation when it is in the stratosphere. Excessive exposure to solar radiation is fully implemented. EPA estimates the discuss our conclusions in section VII.H value of these and related benefits to of this document. associated with adverse health effects, such as skin cancer and cataracts, as equal $4.3 trillion in present value B. Need for Regulation and the well as adverse environmental effects. when discounted at 2 percent over the Objective of This Rule Emissions of CFCs and other ODSs period of 175 years. This amount is This proposed regulation responds to reduce stratospheric ozone equivalent to about $6 trillion after U.S. obligations under the Montreal concentrations through a catalytic adjusting for inflation between 1990 and Protocol, as well as the requirements of reaction, thereby allowing more solar 2004. This estimate includes all benefits the Clean Air Act. The Montreal radiation to reach the Earth’s surface. of total global ODS emission reductions Protocol itself recognizes that the Because of this effect and its expected from the Montreal Protocol regulation of ODSs is necessary because consequences, environmental scientists and is based on reductions from a private markets are very unlikely to from the United States and other baseline scenario in which ODS preserve levels of stratospheric ozone countries advocate ending all uses of emissions would continue to grow for sufficient to protect the public health. In these chemicals. decades but for the Montreal Protocol. private markets, individual users of CFC 2. The Montreal Protocol 4. Characteristics of Asthma MDIs have no significant private incentive to switch to non-ozone- The international effort to craft a OTC epinephrine MDIs are used to depleting products because under coordinated response to the global treat asthma, a chronic respiratory current regulations the environmental environmental problem of stratospheric disease characterized by episodes or and health costs of ozone-depleting ozone depletion culminated in the attacks of bronchospasm on top of products are external to users. Montreal Protocol, an international chronic airway inflammation. These Moreover, should MDI users voluntarily agreement to regulate and reduce attacks can vary from mild to life- internalize these costs by switching to production of ODSs. The Montreal threatening and involve shortness of alternative products, they would not Protocol is described in section I.B.2 of breath, wheezing, cough, or a receive the benefits of their actions. this document. One hundred and combination of symptoms. Many Each user would bear all of the costs ninety-one countries have now ratified factors, including allergens, exercise, and virtually none of the benefits of the Montreal Protocol, and the overall and viral infections may trigger an such a switch, as the environmental and usage of CFCs has been dramatically asthma attack. health benefits would tend to be reduced. In 1986, global consumption of Early release data from the first 6 distributed globally and occur decades CFCs totaled about 1.1 million tonnes, months of the 2006 NHIS indicate that in the future. Thus, the outcome of an and by 2004, total annual production 8.0 percent of people in the United unregulated private market would be had been reduced to 70,000 tonnes (Ref. States have asthma (Ref. 36, fig. 15.5). the continued use of CFC MDIs, even if 34). This decline amounts to more than The prevalence of asthma decreases the social value of reducing emissions a 90-percent decrease in production and with age, with the prevalence being 9.5 were clearly much greater than the price is a key measure of the success of the percent for children ages 0 to 14, premium for non-ozone-depleting Montreal Protocol. Within the United compared to 7.8 percent for persons therapies. States, use of ODSs, and CFCs in ages 15 to 34, and 7.4 percent for adults One of the objectives of this proposed particular, has fallen sharply— ages 35 and over (Ref. 36, fig. 15.5). rule is to respond to the obligations production and importation of CFCs is The early release data from the first 6 under the Montreal Protocol requiring less than 1 percent of 1989 production months of the 2006 NHIS also indicate the United States to reduce atmospheric and importation (Ref. 34). 4.2 percent of Americans had an asthma emissions of ODSs, specifically CFCs. A relevant aspect of the Montreal episode in the previous 12 months, with CFCs and other ODSs deplete the Protocol is that production of CFCs in 5.5 percent of children under age 14, 3.6 stratospheric ozone that protects the any year by any country is generally percent of persons ages 15 to 34, and 4.0 Earth from ultraviolet solar radiation. banned after the phase-out date unless percent of adults over age 35 reporting We are proposing to end the essential- the Parties to the Montreal Protocol episodes (Ref. 36, fig. 15.2).

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According to data from the National than the general population and also are on average, purchases roughly 1.9 to 2.6 Ambulatory Medical Care Survey, in more likely to have had an attack of OTC epinephrine MDIs each year [4.5 2004 there were about 15 million asthma in the previous 12 months. The million MDIs ÷ 1.7 million users = 2.6 outpatient asthma visits to physician CDC notes that although increases have MDIs per user per year; 4.5 million offices and hospital clinics and 1.8 occurred in the numbers and rates of MDIs ÷ 2.3 million users = 1.9 MDIs per million emergency department visits physician office visits, hospital user per year]. (Ref. 37, table 19). According to data outpatient visits, and emergency We estimate 600,000 to 1.3 million from the National Center for Health department visits, these increases are OTC epinephrine MDI users do not Statistics: National Hospital Discharge accounted for by the increase in regularly use prescription asthma Survey, there were 497,000 hospital prevalence. The CDC also notes that products. According to Wyeth admissions for asthma in 2004 (Ref. 37, asthma mortality and asthma Pharmaceuticals, somewhere between table 12) and 4,099 mortalities in 2003 hospitalization rates were declining and 43 percent (Wyeth slide 33) and two- (Ref. 37, table 1). The estimated direct stated that these downward trends thirds (Wyeth slide 32) of OTC medical cost of asthma (hospital might indicate early successes by epinephrine MDI users also use services, physician care, and asthma intervention programs. prescription drugs for treatment of their medications) was $11.5 billion in 2004 asthma. This implies that 600,000 to 1.3 5. Current U.S. Market for OTC (Ref. 37, table 20). million OTC epinephrine MDI users do We estimate that OTC epinephrine Epinephrine MDIs not use prescription asthma medicine MDI users make roughly 280,000 to We estimate that 1.7 million to 2.3 [1,752,653 x .33 = 578,375; 2,336,871 x 370,000 visits to emergency million consumers purchase roughly 4.5 .57 = 1,332,016]. departments and require roughly 75,000 million OTC epinephrine MDIs in the D. Benefits and Costs of the Proposed to 100,000 hospitalizations annually. United States each year, at an average Rule We know of no data or study suggesting price of $13.29 per MDI. OTC epinephrine MDI users differ from Based on data from ACNielsen for the We estimate the benefits and costs of other people with asthma in their risk 52 weeks ending September 9, 2006 government action relative to a baseline of requiring emergency department (Ref. 40), we estimate 3.5 million OTC scenario that, in this case, is a visits or hospitalizations. In a published epinephrine MDIs are sold in the United description of the production, use, and study of 601 people with asthma (Ref. States annually, excluding sales through access to OTC epinephrine MDIs in the 38), the authors did not find any Wal-Mart Stores, Inc. (Wal-Mart).26 absence of a final rule based on this evidence that epinephrine users are Wyeth estimates roughly 25 percent of proposed rule. In this section we first more likely to visit emergency OTC medications such as PRIMATENE describe such a baseline, and then departments or to require MIST, a branded OTC epinephrine MDI present our analysis of the benefits of hospitalization than people with asthma product, are sold through Wal-Mart the rulemaking. We also present an who do not use epinephrine. On the annually (Wyeth slide 32), implying a analysis of the most plausible regulatory other hand, we know of no data total market of roughly 4.5 million OTC alternatives, given the Montreal suggesting that OTC epinephrine MDI epinephrine MDIs sold annually. This is Protocol. Next, we turn to the costs of users are less likely to visit emergency equivalent to 1.3 billion inhalations per the rulemaking and to an analysis of the departments or require hospitalization. year, or 146 million days of therapy (at effects on the Medicare and Medicaid As described in section V.B.2.b of this 9 inhalations per day, the highest programs. recommended long-term dose). document, we estimate that 1.7 to 2.3 1. Baseline Conditions million people with asthma use OTC Based on ACNielsen data (Ref. 40) for epinephrine MDIs. Assuming 1.7 to 2.3 the 52 weeks ending September 9, 2006, We developed baseline estimates of million people with asthma are OTC adjusted for sales through Wal-Mart, we future conditions to assess the economic epinephrine MDI users, and that they estimate OTC epinephrine MDI sales effects of prohibiting marketing of OTC require emergency department visits amount to roughly $60 million in the epinephrine MDIs after December 31, and hospitalization in proportion to United States annually and the average 2010. It is standard practice to use, as their share of the population, OTC U.S. retail price of OTC epinephrine a baseline, the state of the world epinephrine MDI users account for MDIs is $13.29, equivalent to roughly without the rulemaking in question, or roughly 280,000 to 370,000 emergency $0.41 per day of therapy. where the rulemaking implements a department visits annually [15 percent According to American Lung legislative requirement, the world of 1.8 million = 280,000; 20 percent of Association reports derived from the without the statute. For this proposed 1.8 million = 370,000] and 75,000 to National Center for Health Statistics’ rule, we make the baseline assumption 100,000 hospitalizations annually [15 2004 NHIS (Ref. 37, table 10), 11.6 that it is questionable if the United percent of 497,000 = 75,000; 20 percent million individuals reported having had States would be able to obtain an of 497,000 = 100,000].25 an asthma attack in the last 12 months. essential-use allocation for CFCs for the While the prevalence of asthma (the According to Wyeth Pharmaceuticals manufacture of OTC epinephrine MDIs percent of the population diagnosed (Wyeth slide 32), 15 to 20 percent of under the Montreal Protocol for 2010.27 with asthma) has been increasing in adults with asthma that have had an To the extent that new CFCs for recent years, CDC reports that the asthma attack in the previous 12 months production of OTC epinephrine MDIs incidence of asthma (the rate of new use OTC epinephrine MDIs. As we remain available past that date, we diagnoses) has remained fairly constant discussed in section V.B.2.b of this estimate this rulemaking will have since 1997 (Ref. 39). Non-Hispanic document, we estimate that 1.7 to 2.3 quantifiable impacts as summarized in Blacks, children under 17 years old, and million people with asthma use OTC table 2. If CFCs for the production of females have higher incidence rates epinephrine MDIs. Each of these users, OTC epinephrine MDIs are no longer

25The 15 to 20 percent figures were derived, in 26Retail sales data from drug stores and 27Even if there is no essential-use allocation part, from comparing the number of purchasers of supermarkets provided by ACNielsen do not under the Montreal Protocol for the year 2010, OTC epinephrine MDIs to the number of adults include retail sales data from Wal-Mart because production of epinephrine CFC MDIs would likely suffering an asthma incident in the previous 12 Wal-Mart does not participate in ACNielsen continue well into the year with manufacturers months. surveys. using preexisting stocks of CFCs.

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available by the end of 2010, this rule regulation. Such benefits, in any event, In addition, compliance with the will have no impact. were included in EPA’s earlier estimate Montreal Protocol’s directives is subject of benefits. to differences in national 2. Benefits of the Proposed Rule The reduction of CFC emissions implementation procedures. The benefits of a final rule based on associated with removing OTC Economically less-developed nations, this proposed rule include epinephrine CFC MDIs from the U.S. which have slower phase-out schedules environmental and public health market represents only a fraction of 1 than developed nations, have improvements from protecting percent of total global CFC emissions. emphasized that progress in eliminating stratospheric ozone by reducing CFC Current allocations of CFCs for OTC ODSs in developing nations is affected emissions by roughly 70 tonnes epinephrine MDIs account for less than by observed progress of developed annually. Benefits also include 0.1 percent of the total 1986 global nations, such as the United States. If we expectations of increased returns on production of CFCs (Ref. 41). had adopted a later phase-out date, investments in environmentally friendly Furthermore, current U.S. CFC other Parties could attempt to delay technology, reduced risk of unexpected emissions from MDIs represent a much their own control measures. disruption of supply of OTC smaller, but unknown share of the total epinephrine MDIs, and continued emissions reduction associated with 3. Costs of the Proposed Rule and international cooperation to comply EPA’s estimate of $6 trillion in benefits, Alternatives with the spirit of the Montreal Protocol, because that estimate reflects future The costs of removing OTC thereby potentially reducing future emissions growth that has not occurred. epinephrine MDIs from the market emissions of ODSs throughout the If a final rule removing the essential- include the costs of increased physician world. use designation of OTC epinephrine visits, increased use of more expensive Failure to finalize this proposed rule MDIs takes effect before CFCs cease to reliever MDIs, and potential increases in may lead the Parties to the Montreal be available, the proposed rule may the use of controller medications, visits Protocol to consider restrictions on account for some small part of the to emergency departments, and access to the CFCs required to benefits estimated by EPA. However, we hospitalizations. Because we cannot manufacture these OTC epinephrine are unable to assess or quantify specific predict whether OTC epinephrine MDI MDIs products, which could create the reductions in future skin cancers and users will self-medicate or go to a risk of removal of these products from cataracts associated with the reduced physician for a prescription reliever the market. emissions that might be associated with once OTC epinephrine MDIs are a. Reduced CFC emissions. this proposed rule or the regulatory removed from the market, we quantify Withdrawal of OTC epinephrine MDIs alternatives. the costs for two extreme cases. In the from the market will reduce CFC b. Returns on investment in first case, OTC epinephrine MDI users emissions by approximately 70 tonnes environmentally-friendly technology. not already seeing a physician self- per year. Current CFC inventories are Establishing a phase-out date prior to medicate, while those who already see substantial. Nominations for new CFC the expiration of patents on HFA MDI a physician switch from OTC production are generally approved by technology and other aerosolized drug epinephrine MDIs to albuterol HFA the Parties to the Montreal Protocol 2 technology that does not use ODSs MDIs. In the second case, all OTC years in advance. The proposed rule rewards the developers of the ozone-safe epinephrine MDI users visit their would ban marketing of OTC technologies. In particular, such a physician and switch to albuterol HFA epinephrine CFC MDIs after December phase-out date would validate MDIs. We propose these two cases as 31, 2010. There is some uncertainty expectations that the government will reasonable bounds for the expected cost with respect to the amount of inventory protect incentives to research and of removing OTC epinephrine MDIs that will be available in the future, but develop ozone-safe technologies. from the market. the United States’ ability to obtain an Newly developed technologies to a. Self-medication. If all OTC essential-use allocation for CFCs for the avoid ODS emissions have resulted in epinephrine MDI users who do not manufacture of OTC epinephrine MDIs more environmentally ‘‘friendly’’ air already see a physician for asthma were in 2010 is questionable. conditioners, refrigerants, solvents, and to self-medicate once OTC epinephrine In an evaluation of its program to propellants, but only after significant MDIs were no longer available, and administer the Clean Air Act, EPA has investments. Several manufacturers those who do see a physician were to estimated that the benefits of controlling have claimed development costs that increase their albuterol use, we estimate ODSs under the Montreal Protocol are total between $250 million and $400 this rulemaking would result in $360 the equivalent of $6 trillion in 2004 million to develop HFA MDIs and new million to $1.0 billion in increased dollars. However, EPA’s report provides propellant-free devices for the global spending annually. This spending no information on the total quantities of market (Ref. 42). includes $280 million to $1.0 billion reduced emissions or the incremental These investments have resulted in resulting from increased value per tonne of reduced emissions. several innovative products in addition hospitalizations and emergency EPA derived its benefits estimates from to HFA MDIs. For example, breath- department visits, and roughly $30 a baseline that included continued activated delivery systems, dose million to $80 million in increased increases in emissions in the absence of counters, DPIs, and mini-nebulizers spending on more expensive medicines. the Montreal Protocol. We have have also been successfully marketed. Under the assumption of self- searched for authoritative scientific c. International cooperation. The medication, we estimate that removing research that quantifies the marginal advantages of selecting a date that OTC epinephrine MDIs from the market economic benefit of incremental maintains international cooperation are would result in 40,000 to 120,000 more emission reductions under the Montreal substantial because the Montreal hospitalizations for asthma annually, Protocol, but have found none Protocol, like most international and up to 440,000 more asthma-related conducted during the last 10 years. As environmental treaties, relies primarily emergency department visits each year. a result, we are unable to quantify the on a system of national self- These estimates, based on calculations environmental and human health enforcement, although it also includes a throughout this section, do not capture benefits of reduced emissions from this mechanism to address noncompliance. the decreased quality of life of OTC

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epinephrine MDI users, lost = 440,017] and hospitalizations would MDI is roughly equivalent to one OTC productivity, or the cost of alternative increase by roughly 120,000 [56,658 epinephrine MDI. The lower priced therapies, such as herbal remedies, hospitalizations x (3.1 - 1) = 118,983]. albuterol MDIs are currently being caffeine and OTC ephedrine. We do not have data that will allow us withdrawn from the market, and will The authors of a published study to estimate increases in hospitalizations not be available at the time of the found that people with asthma who self- and emergency department visits for proposed effective date of this rule (see medicate with herbal products and patients using other forms of self- 70 FR 71685). The higher price for caffeine, the most common forms of self medication, such as OTC ephedrine. We albuterol HFA MDIs implies that if OTC medication, are at increased risk of request comments that would provide epinephrine MDI users who also use requiring an emergency department visit information allowing us to address this prescription medicine for their asthma or hospitalization (Ref. 38). They found issue. were to increase their use of albuterol that those using herbal treatments are We estimate the 2006 cost of an HFA MDIs when OTC epinephrine 2.5 times as likely to require emergency department visit for asthma MDIs are no longer available, they and hospitalization, and that those who use at roughly $300 and the cost of their insurers would spend roughly $30 caffeine to treat asthma are 3.1 times as hospitalization for asthma at roughly million to $80 million more per year for likely as other people with asthma to $7500. Based on data from the 2004 medicine [1,929,025 MDIs x $16.08 per require both an emergency department National Hospital Discharge Survey, the MDI = $31,022,023; 2,990,736 MDIs x visit and hospitalization. American Lung Association estimates $25.15 per MDI = $76,418,426]. We estimate that OTC epinephrine the 497,000 hospitalizations for asthma In total, self-medication by OTC MDI users who do not use prescription cost roughly $3.6 billion in inpatient epinephrine-only MDI users and medicine for their asthma make roughly care and physician services, equivalent increased albuterol use by those already 100,000 to 200,000 emergency to roughly $7,300 per hospitalization using prescription medicine would department visits and require roughly (Ref. 37). The 1.8 million emergency result in increased spending of $360 25,000 to 50,000 hospitalizations. We department visits for asthma cost about million to $1.0 billion annually estimate OTC epinephrine MDI users $518 million, equivalent to roughly [$282,016,770 + $76,418,426 = make roughly 280,000 to 370,000 $280 per visit. Adjusting these figures $358,435,196; $1,029,639,003 + emergency department visits and for inflation according to the CPI for $31,022,023 = $1,060,661,026]. require about 75,000 to 100,000 medical care, we estimate that the b. Increased physician visits and hospitalizations annually, as described average hospitalization for asthma albuterol use. If, as a result of the in section VII.C.4 of this document. We would cost roughly $7,500 and the removal of OTC epinephrine MDIs from estimate somewhere between 43 percent average emergency department visit for the market, all current OTC epinephrine and two-thirds of OTC epinephrine MDI asthma would cost roughly $300 in MDI users were to seek out prescription users do not use prescription medicine 2006. albuterol HFA MDIs through increasing for their asthma, as discussed in section Based on these estimates, if current the frequency of physician visits, we 6. Assuming that OTC epinephrine MDI OTC epinephrine MDI users who do not estimate that this scenario would result users who do not use prescription currently use prescription medicine in roughly $170 million to $340 million medicine for asthma do not differ in were to self-medicate, the result would in increased health care spending, their rates of hospitalization and be costs of roughly $280 million [37,275 including $100 million to $225 million emergency department visits from those hospitalizations x $7,565.84 = in economic costs through an increase who do use prescription medicine for $282,016,770] to $1.0 billion annually in visits to physicians and $72 million asthma, we estimate that OTC [(118,982 hospitalizations x $7,565.84) + to $114 million in increased spending epinephrine MDI users who do not use (440,017 emergency department visits x on prescription albuterol. prescription medicine for asthma make $294.17) = $1,029,639,003]. We estimate that if current 100,000 to 200,000 emergency Assuming current OTC epinephrine epinephrine users who do not use department visits and require 25,000 to MDI users who do use prescription prescription medicine for their asthma 55,000 hospitalizations annually medicine for asthma increase their use make one additional physician visit per [275,700 emergency department visits x of albuterol HFA MDIs without year to enable them to switch from OTC 1/3 = 91,900 emergency department requiring more frequent physician epinephrine MDIs to albuterol MDIs, the visits; 367,600 emergency department visits, we estimate that they will pay result would be roughly 600,000 to 1.3 visits x (1 - .43) = 209,532 emergency roughly $30 million to $80 million more million additional physician visits department visits; 74,550 for medicine each year. As discussed in annually. This estimate stems directly hospitalizations x 1/3 = 24,850 section 6, somewhere between 43 from the estimate presented in section 6 hospitalizations; 99,400 hospitalizations percent and two-thirds of OTC that there are roughly 600,000 to 1.3 x (1 - .43) = 56,658 hospitalizations]. epinephrine MDI users also use million epinephrine users who do not If current OTC epinephrine MDI users prescription medicine for their asthma. use prescription medicine for their who do not use prescription medicine Assuming current OTC epinephrine asthma. These estimates assume that for asthma were to self-medicate with MDI users who also use prescription OTC epinephrine MDI users who do use herbal treatments, and those self- medicines for their asthma use roughly prescription medicine for their asthma, medicating with herbal treatments face the same number of OTC epinephrine and therefore already make regular 2.5 times the risk of a hospitalization, MDIs per year as those who do not, we physician visits, are able to increase this would imply a lower bound estimate dual users use roughly 2 their albuterol use without increasing increase of roughly 40,000 million to 3 million OTC epinephrine the frequency of those visits. hospitalizations [24,850 hospitalizations MDIs annually [4,486,104 MDIs x 0.43 We estimate the 2006 cost of a x (2.5 - 1) = 37,275]. As an upper bound, = 1,929,025; 4,486,104 MDIs x 2/3 = physician visit for asthma to be roughly if all OTC epinephrine MDI users were 2,990,736 MDIs]. As discussed in the $170. Based on 2004 data from the to self-medicate with caffeine, following section, we estimate an National Ambulatory Medical Care emergency department visits would albuterol HFA MDI will cost between Survey, the American Lung Association increase by roughly 440,000 [209,532 $16 and $25 more than an OTC estimates that 1.5 million physician emergency department visits x (3.1 - 1) epinephrine MDI, and that one albuterol visits and non-emergency outpatient

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hospital visits for asthma cost roughly one albuterol MDI for each OTC VII.D.3.a of this document, we estimate $2.4 billion, equivalent to roughly $160 epinephrine MDI they currently OTC epinephrine MDI users who do not per physician visit. Adjusting these purchase, total expenditures by current use prescription medicines make figures for inflation according to the CPI OTC epinephrine MDI users and their roughly 100,000 to 200,000 emergency for medical care, we estimate that a insurers would increase roughly $70 department visits and require about physician visit for asthma would cost million to $115 million [4,486,104 MDIs 25,000 to 55,000 hospitalizations roughly $170 per visit in 2006. An x $16.08 per MDI = $72,134,239; annually. If they all were to visit their increase of 600,000 to 1.3 million 4,486,104 MDIs x $25.55per MDI = physicians, receive prescriptions for a physician visits each year would $114,627,640]. controller medication, fill them, and use therefore cost roughly $100 million to If, instead of self-medicating, OTC the medication, based on the results of $225 million annually [584,217.75 visits epinephrine MDI users go to the the study of almost 50,000 asthma x $168.966 per visit = $98,712,936; physician and increase their use of patients, we estimate 20 to 40 percent of 1,332,016.47 visits x $168.966 per visit albuterol HFA MDIs, we estimate these emergency department visits and = $225,065,495]. These estimates do not increased spending of roughly $170 hospitalizations could be avoided, take into account the value of the time million to $340 million dollars annually equivalent to roughly 20,000 to 80,000 patients spend visiting their physicians. [$98,712,936 for physician visits + fewer emergency department visits [20 If all current OTC epinephrine MDI $72,134,239 for medicine (albuterol) = percent of 91,900 is 18,380; 40 percent users were to switch to prescription $170,857,175; $225,065,495 in of 209,532 is 83,813] and 5,000 to albuterol HFA MDIs, we estimate the physician visits + $114,627,640 in 10,000 fewer hospitalizations [20 result to be roughly $70 million to $115 medicines = $339,693,135]. percent of 24,850 is 4,970; 40 percent of million in increased spending on These estimated expenditures would 56,658 is 11,332]. Assuming the average medicine. We estimate that it will take decrease dramatically if generic cost for an emergency department visit roughly one albuterol HFA MDI to albuterol HFA MDIs were to be for asthma is about $300 and the average replace each OTC epinephrine MDI introduced to the market. Patents listed cost of a hospitalization for asthma is removed from the market. OTC in ‘‘Approved Drug Products with roughly $7,500, as discussed in section epinephrine MDIs contain roughly 270, Therapeutic Equivalence Evaluations’’ D.3.a of this document, this would 405, or 540 inhalations, depending on (Orange Book) for albuterol HFA MDIs reduce health care costs by roughly $40 the size of the MDI. Based on ACNielsen expire in 2010 and 2017, making those million to $100 million annually data for the 52 weeks ending September possible dates for generic entry. Of [($294.17 per visit x 18,380) + ($7565.84 9, 2006 (Ref. 40), we estimate that the course, unforeseen introduction of per hospitalization x 4,970) = average OTC epinephrine MDI alternative therapies could reduce these $41,236,000; ($294.14 per visit x 83,813) contained 293 inhalations, equivalent to expected increases in expenditures. + ($7565.84 per hospitalization x These increased expenditures 32.6 days of therapy, assuming OTC 11,332) = $105,837,600]. This cost is represent, to some extent, transfers from epinephrine MDI users use, but do not roughly $70 to $80 per current OTC consumers and third-party payers, exceed, the long term maximum epinephrine MDI user per year including the Federal Government and recommended dose of 9 inhalations per [$41,236,000 / 584,218 OTC State governments, to pharmaceutical day. The usual dosage of albuterol HFA epinephrine only MDI users = $70.58; manufacturers, patent holders, and MDIs is 8 to 12 inhalations per day, and $105,837,600 / 1,332,016 OTC other residual claimants. However, to albuterol HFA MDIs contain 200 epinephrine only MDI users = $79.46]. inhalations, implying that each MDI some extent, these increased We looked at a range of CFC-free expenditures represent purchases of contains 17 to 25 days of therapy per controller medications such as products that are more costly to MDI. Allowing for the greater FLOVENT HFA, ASMANEX manufacture and bring to market, and, therapeutic effectiveness of albuterol TWISTHALER, PULMICORT therefore, would be social costs. We are compared to epinephrine, we estimate it TURBOHALER, and QVAR, and found unable to estimate the fraction of those will take roughly one albuterol HFA the wholesale price of the smallest dose increased expenditures on drugs that MDI to replace each OTC epinephrine of the least expensive medication to be constitute social costs. MDI removed from the market. roughly $1.00 per day of therapy,28 Based on ACNielsen data from the 52 c. Controller medication. We estimate equivalent to roughly $370 per patient weeks ending September 9, 2006 (Ref. that the cost to current OTC epinephrine year of therapy. On average, the cost of 40), we estimate the average retail price MDI users of filling additional increasing the use of controller of an OTC epinephrine MDI to be prescriptions for controller medications medication among current OTC $13.29. Based on average retail sales would, on average, exceed the potential epinephrine MDI users who do not prices across all payer types for the first direct cost savings from reducing currently use prescription medicine half of 2004, the average albuterol HFA hospitalizations and emergency would exceed the benefits, in terms of MDI cost $39.42 (Ref. 43). This estimate department visits by more than $280 per decreased emergency department visits does not reflect less expensive albuterol current OTC epinephrine MDI user. and hospitalizations, by over $280 per HFA MDIs introduced to the market In a study of almost 50,000 asthma since that time. Some market analysts patients (Ref. 45), the authors found that person per year. This number would be also predict that albuterol HFA MDI patients with low adherence to lower if a greater fraction of people with prices will decline up to 20 percent as controller medication have significantly asthma at high risk of emergency the market switches away from albuterol higher risk (odds ratio of 1.72) of department visits were to begin using CFC MDIs and large payers use their emergency department visits or of controller medication on a regular basis, market power to drive down prices (Ref. hospitalization relative to patients with and higher if a greater fraction of low 44). Taking these factors into moderate or high adherence. The study risk people with asthma were to begin consideration, we estimate the average found that patients receiving high daily using controller medication on a regular retail price of an albuterol HFA MDI is doses of controller medication had the 28Analysis completed by FDA based on $30 or more, a price increase of roughly lowest risk (odds ratio of .37) of information provided by IMS Health, IMS National $16 to $25 per MDI. If current OTC emergency department visits or of Sales Perspective (TM), 2005, extracted March epinephrine MDI users must purchase hospitalization. As discussed in section 2006.

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basis. These estimates do not take into medicine were to self-medicate, and if of $339,693,135 = 84,923,284]. These account the impact of asthma attacks on those who do self-medicate were to estimates exclude costs that may result individuals’ quality of life and switch to albuterol, Federal Medicaid from increased prescribing of controller productivity. spending would increase roughly $70 medications, and do not take into million to $250 million annually [20 account the impact of asthma attacks on 4. Effects on Medicaid and Medicare percent of $360 million = $72 million; individuals’ quality of life and As a result of the removal of OTC 25 percent of 1 billion = $250 million]. productivity. epinephrine CFC MDIs from the market, If all current epinephrine users eligible we estimate State and Federal Medicaid for Medicaid were to instead visit their E. Alternative Phase-Out Dates spending will increase $35 million to physicians and use prescription The alternatives we considered $250 million annually and that Federal albuterol, we estimate that Federal included the following phase-out dates: Medicare spending, together with Medicaid spending would increase by 1. December 31, 2008; private spending by Medicare $35 million to $85 million dollars 2. December 31, 2009; beneficiaries, will increase $20 million annually [20 percent of $170,857,175 = 3. December 31, 2010 (the proposed to $250 million annually. Some OTC $34,171,435; 25 percent of $339,693,135 rule). epinephrine MDI users may be eligible = $84,923,284]. These estimates exclude Spending per year does not differ for both Medicare and Medicaid. To the costs that may result from increased among the regulatory alternatives. The extent this population is large, these prescribing of controller medications, only difference among the alternatives is estimates overstate potential spending and do not take into account the impact how long the estimated costs shown in increases from this proposed rule by of asthma attacks on individuals’ quality table 2 of this document would accrue. counting these individuals twice: once of life and productivity. At some time in the near future, the in Medicaid estimates and once in b. Medicare. We estimate 10 percent unavailability of CFCs—not the Medicare estimates. We are unable to to 25 percent of the costs of the removal proposed rule or an alternative—may estimate the size of the population of of OTC epinephrine MDIs from the lead to removal of OTC epinephrine OTC epinephrine MDI users eligible for market will be paid by Federal Medicare from the marketplace. Our current belief both programs. spending and by Medicare beneficiaries. is that bulk CFCs are likely to be a. Medicaid. We estimate that 20 to 25 If all Medicare-eligible OTC epinephrine unavailable in 2010 (see section VII.A), percent of the costs of the removal of MDI users were to self-medicate upon so the costs for the first alternative OTC epinephrine MDIs from the market implementation of this proposed rule, would be the present value of the will be born by State and Federal Federal Medicare spending and annual costs for 2 years, 2008–2009, and Medicaid programs, equivalent to $70 spending by Medicare beneficiaries the cost for the second alternative million to $250 million annually if would increase roughly $40 million to would be the present value of the costs Medicaid-eligible OTC epinephrine MDI $250 million dollars annually. for 1 year, 2009. The third alternative, users who do not use prescription Alternatively, if all Medicare-eligible which is the proposed rule, would have medicine for their asthma were to self- OTC epinephrine MDI users were to no quantifiable costs or benefits. We medicate upon implementation of this visit their doctors to obtain and fill invite comments on these projections proposed rule, and equivalent to $35 prescriptions for albuterol, Federal and on the costs and benefits of any million to $85 million annually if Medicare spending and spending by other possible alternative effective Medicaid-eligible OTC epinephrine MDI Medicare beneficiaries would increase dates, such as December 31, 2011 or users were to visit their physicians to roughly $20 to $85 million annually. 2012. obtain and fill prescriptions to enable Assuming epinephrine users with F. Sensitivity Analyses them to switch to albuterol. Assuming insurance, including Medicare, are more epinephrine users with insurance, likely to visit a doctor, and less likely The estimated costs summarized in including Medicaid, are more likely to to self-medicate, the costs of this table 2 incorporate a range of estimates visit a doctor, and less likely to self- proposed rule are more likely to fall in about the price increases consumers and medicate, the costs of this proposed rule the $20 million to $85 million range. other payers will face, the size of the are more likely to fall in the $35 million According to proprietary surveys affected market, and the consequences to $85 million range. conducted by or for Wyeth between of consumers’ response to the removal According to proprietary surveys 1993 and 2005 (Wyeth slide 31), 16 of OTC epinephrine MDIs from the conducted by or for Wyeth between percent to 33 percent of OTC market. This represents the full range of 1993 and 1994 (Wyeth slide 31), 27 epinephrine MDI users are over the age uncertainty for the estimated effects of percent to 33 percent of OTC of 55, implying the percentage of this proposed rule. The full range epinephrine MDI users had incomes of epinephrine users over the age of 65, incorporates the ranges of estimates for less than $20,000 at the time the surveys and therefore eligible for Medicare, the individual uncertain variables in the were conducted. A 2005 Internet survey must be lower. Accordingly, if we analysis. conducted by Wyeth found that 20 assume 10 percent to 25 percent of OTC In each section of the document, we percent of OTC epinephrine MDI users epinephrine MDI users are over the age show the ranges associated with each had incomes of less than $25,000. of 65, Medicare spending and private major uncertain variable, taking into Eligibility for Medicaid varies by State spending by Medicare beneficiaries account the possibility that in response but is generally tied to the Federal would increase $40 million to $250 to the removal of OTC epinephrine poverty guidelines (Ref. 46). The 2006 million annually if all Medicare-eligible MDIs from the market, OTC epinephrine Federal poverty guidelines establish a OTC epinephrine MDI users were to MDI users who do not currently use poverty threshold of $20,000 in annual self-medicate [10 percent of $360 prescription medicines will either self- income for a family of four (Ref. 47). million = $36 million; 25 percent of $1.0 medicate or visit a physician to get an Accordingly, if we assume 20 percent to billion = $250 million], and by $20 albuterol prescription. The estimated 25 percent of OTC epinephrine MDI million to $85 million annually if they increases in emergency department users are eligible for Medicaid, if were all to visit their physicians for visits and hospitalizations depend upon Medicaid-eligible OTC epinephrine MDI prescription albuterol [10 percent of a range of estimates of the percentage of users who do not use prescription $170,857,125 = $17 million; 25 percent people with asthma that use OTC

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epinephrine MDIs (15 to 20 percent) and significantly. If CFCs cease to be additional opportunity for public the fraction of OTC epinephrine MDI available for OTC epinephrine MDIs comment. We will provide details on users that do not use prescription before the effective date of a final rule the meeting in a notice published in the medicines and are therefore more likely removing the essential-use designation Federal Register in the near future. to self-medicate (somewhere between 33 of OTC epinephrine MDIs, however, this XII. References and 57 percent), as well as the rate we proposed rule would have no benefits or estimate hospitalizations and emergency costs. We specifically request comments The following references have been department visits will increase among on the costs and benefits of this placed on display in the Division of this population (2.5 to 3.1 times). proposed rule. Dockets Management, 5630 Fishers Similarly, estimates of the impact of Lane, rm. 1061, Rockville, MD 20852, the removal of OTC epinephrine MDIs VIII. Regulatory Flexibility Analysis and may be seen by interested persons from the market on public and private The Regulatory Flexibility Act between 9 a.m. and 4 p.m., Monday spending depends on whether or not requires agencies to analyze regulatory through Friday. FDA has verified the OTC epinephrine MDI users self- options that would minimize any Web site addresses, but we are not medicate, the above estimates on significant impact of a rule on small responsible for subsequent changes to increased hospitalizations and entities. Because known current the Web site after this document emergency department visits, and the producers are not small entities and the publishes in the Federal Register.29 cost of those visits. A range of estimates likelihood that the proposed rule will 1. National Center for Health Statistics, of the percentage of adults with asthma not impose compliance costs, the ‘‘Early Release of Selected Estimates Based that use OTC epinephrine MDIs (15 to agency does not believe that this on Data From the 2005 National Health 20 percent) and the fraction of OTC proposed rule would have a significant Interview Survey,’’ figure 15.4, available at http://www.cdc.gov/nchs/data/nhis/ epinephrine MDI users that do not use economic impact on a substantial _ prescription medicine for their asthma earlyrelease/200606 15.pdf. number of small entities. FDA requests 2. Alkermes, Inc., press release, dated (somewhere between 33 and 57 comment on this issue. March 22, 2004, available at http:// percent), in addition to the overall size www.alkermes.com/newsroom/ of the OTC epinephrine MDI market, IX. The Paperwork Reduction Act of 1995 showArticle.aspx?id=267. determines the number of additional 3. Fu, K. et al., ‘‘Air-Epinephrine: physician visits these users will require We have tentatively concluded that Inhalation Therapy for the Emergency Self- to switch from OTC epinephrine MDIs this proposed rule contains no Treatment of Anaphylaxis,’’ Journal of to albuterol MDIs. Estimated increases collection of information. Therefore, Aerosol Medicine, Vol. 16(2):190, June 2003. in spending on medicine depend on the clearance by the Office of Management 4. Hendeles, L. et al., ‘‘Response to size of the OTC epinephrine MDI and Budget under the Paperwork Nonprescription Epinephrine Inhaler During market, and the price premium current Reduction Act of 1995 is not required. Nocturnal Asthma,’’ Annals of Allergy, Asthma, and Immunology, 95:530, December OTC epinephrine MDI users can expect X. Federalism 2005. to pay for their medicine, roughly $16 5. National Heart, Lung, and Blood to $25 per MDI. We have analyzed this proposed rule Institute, ‘‘Expert Panel Report 2: Guidelines in accordance with the principles set G. Conclusion for the Diagnosis and Management of forth in Executive Order 13132. We Asthma,’’ NIH publication No. 97–4051, July Limits in available data prevent us have tentatively determined that the 1997. from quantifying the costs and benefits rule does not contain policies that have 6. National Heart, Lung, and Blood of the proposed rule and weighing them substantial direct effects on the States, Institute, ‘‘Expert Panel Report: Update on in comparable terms. The benefits of on the relationship between the Selected Topics 2002: Guidelines for the international cooperation to reduce ODS National Government and the States, or Diagnosis and Management of Asthma,’’ NIH emissions are potentially enormous but on the distribution of power and publication No. 02–5074, June 2003. difficult to attribute to any of the small 7. National Asthma Council Australia Ltd., responsibilities among the various ‘‘Asthma Management Handbook: 2002,’’ steps, such as this rulemaking, that levels of government. Consequently, we Melbourne:2002. make such cooperation effective. As do not currently plan to prepare a 8. Boulet, J. P. et al., ‘‘Canadian Asthma discussed above in detail, the benefits of federalism summary impact statement Consensus Report, 1999,’’ Canadian Medical the removal of OTC epinephrine MDIs for this rulemaking procedure. We Association Journal, 161(11 Supp.):S1, from the market include environmental invite comments on the federalism November 30, 1999. and public health improvements from implications of this proposed rule. 9. Dickinson, B. D. et al., ‘‘Safety of Over- protecting stratospheric ozone by the-Counter Inhalers for Asthma: Report of reducing CFC emissions. Benefits also XI. Request for Comments the Council on Scientific Affairs,’’ Chest, include expectations of increased Interested persons may submit to the 118(2):522, August 2000. returns on investments in 10. Cohen, R. A. and M. E. Martinez, Division of Dockets Management (see ‘‘Health Insurance Coverage: Estimates from environmentally friendly technology, ADDRESSES) written comments regarding the National Health Interview Survey, 2005,’’ reduced risk of unexpected disruption this proposal. Submit a single copy of National Center for Health Statistics, June of supply of CFC MDIs, and continued electronic comments or two copies of 2006, available at http://www.cdc.gov/nchs/ international cooperation to comply any mailed comments, except that data/nhis/earlyrelease/insur200606.pdf. with the spirit of the Montreal Protocol, individuals may submit one paper copy. 11. U.S. Census Bureau, ‘‘Table HI01. thereby potentially reducing future Comments are to be identified with the Health Insurance Coverage Status and Type emissions of ODSs throughout the docket number found in brackets in the of Coverage by Selected Characteristics: 2004: world. The removal of OTC epinephrine heading of this document. Received All Races,’’ available at http:// MDIs from the market could potentially pubdb3.census.gov/macro/032005/health/ comments may be seen in the Division h01_001.htm. cost public and private consumers of of Dockets Management between 9 a.m. OTC epinephrine MDIs hundreds of and 4 p.m., Monday through Friday. 29FDA has verified all Web site addresses cited millions of dollars annually, and An upcoming public meeting on the in this document, but FDA is not responsible for increase hospitalizations and emergency essential-use status of OTC MDIs any subsequent changes to the Web sites after this department visits for asthma containing epinephrine will provide an document has published in the Federal Register.

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Gibson, P., ‘‘Association Between Epidemiology & Statistics Unit, Research and part 2 continues to read as follows: Scientific Affairs, July 2006. Availability of Non-Prescription b2 Agonist 38. Blanc, P. D. et al., ‘‘Use of Herbal Authority: 15 U.S.C. 402, 409; 21 U.S.C. Inhalers and Undertreatment of Asthma,’’ 321, 331, 335, 342, 343, 346a, 348, 351, 352, British Medical Journal, 306:1514, June 5, Products, Coffee or Black Tea, and Over-the- 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 1993. Counter Medications as Self-Treatments 22. Giraud, V., and N. Roche, ‘‘Misuse of Among Adults with Asthma,’’ Journal of 7671 et seq. Allergy and Clinical Immunology, 100:(6\1) Corticosteroid Metered-Dose Inhaler Is § 2.125 [Amended] Associated With Decreased Asthma 789, December 1997. Stability,’’ European Respiratory Journal, 39. Mannino, D. M. et al., ‘‘Surveillance for 2. In § 2.125, remove and reserve Asthma—United States, 1980–1999,’’ 19:246, 2002. paragraph (e)(2)(v). 23. Scarfone, R. J. et al., ‘‘Demonstrated Morbidity and Mortality Weekly Report, Use of Metered-Dose Inhalers and Peak Flow 51(SS01):1–13, March 29, 2002. Dated: February 5, 2007. Meters by Children and Adolescents with 40. Analysis completed by FDA based on Jeffrey Shuren, Acute Exacerbations,’’ Archives of Pediatric retail sales data from drug stores and Assistant Commissioner for Policy. and Adolescent Medicine,’’ 156:378, April supermarkets provided by ACNielsen for the 52 weeks ending September 9, 2006. 2002. Editorial note: This document was 41. U.S. Environmental Protection Agency, 24. Williams, M. V., ‘‘Inadequate Literacy received at the Office of the Federal Register Is a Barrier to Asthma Knowledge and Self- final rule, ‘‘Protection of Stratospheric on September 17, 2007. Care,’’ Chest, 114(4):1008, October 1998. Ozone: Allocation of Essential Use 25. Cloutier, M. et al., ‘‘Use of Asthma Allowances for Calendar Year 2006,’’ 71 FR [FR Doc. 07–4663 Filed 9–17–07; 12:01 pm] Guidelines by Primary Care Providers to 58504, October 4, 2006. BILLING CODE 4160–01–S Reduce Hospitalizations and Emergency 42. Rozek, R. P., and E. R. Bishko, Department Visits in Poor, Minority, Urban ‘‘Economics Issues Raised in the FDA’s Children,’’ Journal of Pediatrics, 146:591, Proposed Rule on Removing the Essential- May 2005. Use Designation for Albuterol MDIs,’’ 26. Overbeek, S. E. et al., ‘‘Is Delayed National Economic Research Associates, Introduction of Inhaled Corticosteroids August 13, 2004 (FDA Docket No. 2003P– Harmful in Patients With Obstructive 0029/C25). Airways Disease (Asthma and COPD)?’’ 43. Analysis completed by FDA based on Chest, 110(1):35, July 1996. prescription data provided by IMS Health, 27. Selroos, O. et al., ‘‘Effect of Early vs National Prescription Audit, 2004; IMS Late Intervention With Inhaled Health, IMS MIDAS (TM), Q1/2004–Q2/2004.

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DEPARTMENT OF JUSTICE online at http://www.regulations.gov Substances Act to permit certain and in the Drug Enforcement qualifying physicians to dispense and Drug Enforcement Administration Administration’s public docket. Such prescribe Schedule III, IV, and V information includes personal narcotic controlled substances approved 21 CFR Part 1301 identifying information (such as your by the Food and Drug Administration [Docket No. DEA–275P] name, address, etc.) voluntarily specifically for use in maintenance or submitted by the commenter. detoxification treatment to up to 100 RIN 1117–AA99 If you want to submit personal patients at any one time, after the identifying information (such as your practitioner submits to the Secretary of Changes to Patient Limitation for name, address, etc.) as part of your Health and Human Services a Dispensing or Prescribing Approved comment, but do not want it to be notification of the practitioner’s need Narcotic Controlled Substances for posted online or made available in the and intent to treat the increased number Maintenance or Detoxification public docket, you must include the of patients. The amendment was made Treatment by Qualified Individual phrase ‘‘PERSONAL IDENTIFYING as part of the Office of National Drug Practitioners INFORMATION’’ in the first paragraph Control Policy Reauthorization Act of AGENCY: Drug Enforcement of your comment. You must also place 2006 (ONDCPRA) (§ 1102 of Pub. L. Administration (DEA), Justice. all the personal identifying information 109–469, 120 Stat. 3502). This Notice of Proposed Rulemaking ACTION: Notice of Proposed Rulemaking. you do not want posted online or made available in the public docket in the first (NPRM) would conform DEA SUMMARY: The Drug Enforcement paragraph of your comment and identify regulations to Pub. L. 109–56 by Administration (DEA) is proposing to what information you want redacted. removing the requirement in 21 CFR conform its regulations to recent If you want to submit confidential 1301.28(b)(iv) that limits to 30 the statutory amendments to the Controlled business information as part of your number of patients that could receive Substances Act that changed certain comment, but do not want it to be maintenance or detoxification treatment patient limitations for practitioners who posted online or made available in the through a group practice. This change dispense or prescribe certain narcotic public docket, you must include the means that each qualifying practitioner drugs for maintenance or detoxification phrase ‘‘CONFIDENTIAL BUSINESS whether working individually or in a treatment. INFORMATION’’ in the first paragraph group practice may offer maintenance and detoxification treatment to 30 DATES: Written comments must be of your comment. You must also patients at any one time. This NPRM postmarked, and electronic comments prominently identify confidential would also conform DEA regulations to must be sent, on or before November 19, business information to be redacted § 1102 of Pub. L. 109–469 by permitting 2007. within the comment. If a comment has so much confidential business certain qualifying physicians to treat up ADDRESSES: To ensure proper handling to 100 patients. To qualify to treat the of comments, please reference ‘‘Docket information that it cannot be effectively redacted, all or part of that comment additional patients, not sooner than one No. DEA–275’’ on all written and year after the practitioner submitted the electronic correspondence. Written may not be posted online or made available in the public docket. initial notification, the practitioner must comments being sent via regular mail submit a second notification to the should be sent to the Deputy Assistant Personal identifying information and confidential business information Secretary of Health and Human Services Administrator, Office of Diversion of the need and intent of the practitioner Control, Drug Enforcement identified and located as set forth above will be redacted and posted online and to treat up to 100 patients. Further, the Administration, Washington, DC 20537, practitioner must be a ‘‘qualifying Attention: DEA Federal Register placed in the Drug Enforcement Administration’s public docket file. If physician’’ under 21 U.S.C. 823(g)(2)(G) Representative/ODL. Written comments and must have the capacity to refer the sent via express mail should be sent to you wish to inspect the agency’s public docket file in person by appointment, patients to whom the individual DEA Headquarters, Attention: DEA practitioner will provide narcotic drugs please see the FOR FURTHER INFORMATION Federal Register Representative/ODL, or combinations of narcotic drugs for CONTACT paragraph. 2401 Jefferson-Davis Highway, appropriate counseling and other Alexandria, VA 22301. Comments may FOR FURTHER INFORMATION CONTACT: appropriate ancillary services (21 CFR be sent directly to DEA electronically by Mark W. Caverly, Chief, Liaison and 1301.28(b)(1)(i) and (ii)). These sending an electronic message to Policy Section, Office of Diversion proposed amendments would not [email protected]. Control, Drug Enforcement change the requirement that each Comments may also be sent Administration, Washington, DC 20537, practitioner must first qualify to electronically through http:// Telephone (202) 307–7297. prescribe and dispense these www.regulations.gov using the SUPPLEMENTARY INFORMATION: medications for maintenance and electronic comment form provided on Overview detoxification treatment, or must be that site. An electronic copy of this prescribing these approved substances document is also available at the On August 2, 2005, the President using the ‘‘good faith’’ exception, found http://www.regulations.gov Web site. signed amendments to the Controlled within current regulations at 21 CFR DEA will accept attachments to Substances Act to increase the patient 1301.28(e). electronic comments in Microsoft word, limitation on prescribing drug addiction WordPerfect, Adobe PDF, or Excel file treatments by qualified medical Background formats only. DEA will not accept any practitioners in group practices from 30 On October 17, 2000, Congress passed file formats other than those specifically patients for each group to 30 patients for the Drug Addiction Treatment Act of listed here. each qualified practitioner in a group 2000 (DATA), amending the Controlled Posting of Public Comments: Please (Pub. L. 109–56; 119 Stat. 591) (21 Substances Act (CSA) (21 U.S.C. § 801 et note that all comments received are U.S.C. 823(g)(2)). seq.) to establish ‘‘waiver authority for considered part of the public record and On December 29, 2006, the President physicians who dispense or prescribe made available for public inspection signed amendments to the Controlled certain narcotic drugs for maintenance

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treatment or detoxification treatment’’ that could be treated by physicians in dependent patients by removing the 30 (Pub. L. 106–310, title XXXV; 114 Stat. group practices. patient limit for group practices and by 1222, codified at 21 U.S.C. 823(g)(2)). Pursuant to Pub. L. 109–56 effective permitting certain qualifying physicians Prior to DATA, the Controlled on August 2, 2005, and § 1102 of Pub. to treat up to 100 patients after certain Substances Act and DEA regulations L. 109–469 effective on December 29, criteria are met. Thus the changes required practitioners who wanted to 2006, this NPRM would make would provide greater access to care for conduct maintenance or detoxification conforming changes to DEA’s patients due to increased patient limits. treatment using narcotic controlled regulations at 21 CFR 1301.28(b)(1)(iii) Executive Order 12866 drugs to be registered as a Narcotic and (iv). Specifically, paragraph Treatment Program (NTP) in addition to (b)(1)(iii) is proposed to be amended to The Deputy Assistant Administrator the practitioner’s individual permit the treatment of up to 100 further certifies that this rule has been registration. The separate NTP patients by a qualifying practitioner if drafted in accordance with the registration authorized the practitioner the necessary criteria are met and principles in Executive Order 12866 to dispense or administer, but not notification is submitted to the § 1(b). It has been determined that this prescribe, narcotic drugs. Secretary of Health and Human is a significant regulatory action and, With passage of DATA, DEA Services. Further, paragraph (b)(1)(iii) is therefore, this action has been reviewed published a NPRM (68 FR 37429; June proposed to be amended by removing by the Office of Management and 24, 2003) proposing to amend the the phrase ‘‘Where the individual Budget. This rule will not impose regulations affecting maintenance and practitioner is not a member of a group additional costs on practitioners as it detoxification treatment for narcotic practice,’’ since there is no longer a simply increases the number of patients treatment by establishing an exemption distinction between practitioners in that a practitioner may treat for narcotic from the separate registration group practices and those practicing dependence. As previously noted, this requirement. After consideration of the independently. Finally, paragraph change would provide greater access to comments received on the NPRM, DEA (b)(1)(iv) is proposed to be deleted to care for patients due to the increased published a Final Rule on June 23, 2005 remove language regarding members of patient limits. (70 FR 36338). The June 23, 2005, Final group practices. Executive Order 12988 Rule permitted the following: Relevant to the change regarding the (1) Qualifying physicians to dispense treatment of up to 100 patients, the This rule meets the applicable and prescribe Schedule III, IV, and V Director of the Center for Substance standards set forth in §§ 3(a) and 3(b)(2) narcotic controlled drugs approved by Abuse Treatment in the Department of of Executive Order 12988, Civil Justice the Food and Drug Administration Health and Human Services issued a Reform. specifically for use in maintenance or letter announcing the statutory change Executive Order 13132 detoxification treatment. as follows: (2) Narcotic-dependent patients to Under ONDCPRA (effective December 29, This rule does not preempt or modify have one-on-one consultations with a 2006), physicians who meet the following any provision of State law; nor does it practitioner in a private practice setting. criteria may notify the Secretary of Health impose enforcement responsibilities on (3) Pharmacies to fill prescriptions for and Human Services (HHS) of their need and any State; nor does it diminish the Schedule III, IV, and V narcotic intent to treat up to 100 patients at any time: power of any State to enforce its own (1) The physician must currently be qualified controlled drugs approved by the Food under DATA 2000; (2) at least one year must laws. Accordingly, this rulemaking does and Drug Administration specifically for have elapsed since the physician submitted not have Federalism implications use in maintenance or detoxification the initial notification for authorization; (3) warranting the application of Executive treatment. the physician must certify their capacity to Order 13132. (4) Practitioners to offer maintenance refer patients for appropriate counseling and Unfunded Mandates Reform Act of 1995 and detoxification treatment with other appropriate ancillary services; and (4) Schedule III, IV, and V narcotic the physician must certify that the total This rule will not result in the controlled drugs approved by the Food number of patients at any one time will not exceed the applicable number. expenditure by State, local, and tribal and Drug Administration specifically for governments, in the aggregate, or by the use in maintenance or detoxification DEA emphasizes that practitioners private sector, of $120,000,000 or more treatment to no more than 30 patients in must meet these HHS criteria before (adjusted for inflation) in any one year, their private practices without having a prescribing a Schedule III, IV, or V and will not significantly or uniquely second registration as a NTP. controlled substance for narcotic affect small governments. Therefore, no The exemption and other maintenance or detoxification treatment actions were deemed necessary under amendments established by the Final to more than 30 patients at any one the provisions of the Unfunded Rule apply to individual practitioners time. Mandates Reform Act of 1995. working in traditional NTPs as well as Regulatory Certifications Congressional Review Act any other practice setting. The rule does not affect the existing prohibition Regulatory Flexibility Act This rule is not a major rule as against prescribing any Schedule II The Deputy Assistant Administrator, defined by § 804 of the Small Business narcotic controlled drugs for Office of Diversion Control, has Regulatory Enforcement Fairness Act of maintenance or detoxification reviewed this regulation and hereby 1996 (Congressional Review Act). This treatment. certifies that it has been drafted in rule will not result in an annual effect Under the provisions of DATA accordance with the Regulatory on the economy of $100,000,000 or implementing regulations as codified in Flexibility Act (5 U.S.C. 601–612) and more; a major increase in costs or prices; 21 CFR 1301.28(b)(1)(iii) and (iv), the that it will not have a significant or significant adverse effects on 30-patient limitation applied equally to economic impact on a substantial competition, employment, investment, individual practices and to group number of small entities. This NPRM productivity, innovation, or on the practices (i.e., 30 patients per group), would relieve a restriction on ability of United States-based severely limiting the number of patients practitioners desiring to treat narcotic companies to compete with foreign

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based companies in domestic and DEPARTMENT OF TRANSPORTATION 2251. Alternatively, comments may be export markets. submitted to the Federal eRulemaking Federal Highway Administration portal at http://www.regulations.gov. List of Subjects in 21 CFR Part 1301 All comments should include the 23 CFR Part 950 Administrative practice and docket number that appears in the procedure, Drug traffic control, Security [FHWA Docket No. FHWA–06–23597] heading of this document. All comments received will be available for measures. RIN 2125–AF07 examination and copying at the above For the reasons set out above, 21 CFR address from 9 a.m. to 5 p.m., e.t., part 1301 is proposed to be amended as Interoperability Requirements, Monday through Friday, except Federal Standards, or Performance follows: holidays. Those desiring notification of Specifications for Automated Toll receipt of comments must include a self- PART 1301—REGISTRATION OF Collection Systems addressed, stamped postcard or you MANUFACTURERS, DISTRIBUTORS, AGENCY: Federal Highway may print the acknowledgment page AND DISPENSERS OF CONTROLLED Administration (FHWA); DOT. that appears after submitting comments SUBSTANCES ACTION: Notice of proposed rulemaking electronically. Anyone is able to search (NPRM); request for comments. the electronic form of all comments in 1. The authority citation for part 1301 any one of our dockets by the name of continues to read as follows: SUMMARY: As required under section the individual submitting the comment Authority: 21 U.S.C. §§ 821, 822, 823, 824, 1604(b)(6) of the Safe, Accountable, (or signing the comment, if submitted 871(b), 875, 877, 886a, 951, 952, 953, 956, Flexible, Efficient Transportation Equity on behalf of an association, business, or 957. Act: A Legacy for Users (SAFETEA–LU), labor union). You may review the DOT’s this proposed rule specifies the complete Privacy Act Statement in the 2. § 1301.28 is proposed to be interoperability requirements for Federal Register published on April 11, amended by revising paragraph automated toll collection systems for the 2000 (Volume 65, Number 70, Pages (b)(1)(iii) and removing paragraph facilities that are tolled under any of the 19477–78) or you may visit http:// (b)(1)(iv) to read as follows: tolling programs contained in section dms.dot.gov. 1604 of SAFETEA–LU. Specifically, this FOR FURTHER INFORMATION CONTACT: For § 1301.28 Exemption from separate notice proposes to require facilities registration for practitioners dispensing or technical questions or information about operating with authority under section this notice of proposed rulemaking, prescribing Schedule III, IV, or V narcotic 1604 of SAFETEA–LU to use electronic controlled drugs approved by the Food and contact Mr. Robert Rupert, FHWA Office toll collection systems and for these of Operations, (202) 366–2194. For legal Drug Administration specifically for use in systems to address their interoperability maintenance or detoxification treatment. questions, please contact Mr. Michael with other toll facilities. Although a Harkins, Attorney Advisor, FHWA * * * * * nationwide interoperability standard Office of the Chief Counsel, (202) 366– (b)(1) * * * has not yet been established, this 4928, Federal Highway Administration, proposed rule seeks to accelerate (iii) The total number of patients to 1200 New Jersey Avenue, SE., progress toward achieving nationwide whom the individual practitioner will Washington, DC 20590. Office hours for interoperability by requiring these the FHWA are from 7:45 a.m. to 4:15 provide narcotic drugs or combinations facilities to upgrade their electronic toll of narcotic drugs under this section will p.m., e.t., Monday through Friday, collection systems to the national except Federal holidays. not exceed 30 at any one time unless, standards whenever adopted. This SUPPLEMENTARY INFORMATION: not sooner than 1 year after the date on document also provides notice of public which the practitioner submitted the meetings on this proposed regulation. Electronic Access and Filing initial notification to the Secretary of DATES: The public meeting will be held Health and Human Services, the You may submit or retrieve comments on Thursday, October 11, 2007, from online through the Document practitioner submits a second 1:30 p.m. to 5 p.m., at the U.S. Management System (DMS) at: http:// notification to the Secretary of the need Department of Transportation dmses.dot.gov/submit. Electronic and intent of the practitioner to treat up headquarters conference center. submission and retrieval help and to 100 patients. A second notification Comments must be received on or guidelines are available under the help under this subparagraph shall contain before November 19, 2007. Late-filed section of the Web site. Alternatively, the certifications required by comments will be considered to the internet users may access all comments subparagraphs (i) and (ii) of this extent practicable, but the FHWA may received by the DOT Docket Facility by paragraph. The Secretary of Health and issue a final rule at any time after the using the universal resource locator Human Services may promulgate close of the comment period. (URL) http://dms.dot.gov. It is available regulations to change the total number ADDRESSES: The October 11, 2007, 24 hours each day, 365 days each year. of patients. public meeting will be held at the U.S. Please follow the instructions. An * * * * * Department of Transportation electronic copy of this document may headquarters conference center, 1200 also be downloaded by accessing the Dated: September 13, 2007. New Jersey Avenue, SE., Washington, Office of the Federal Register’s home Joseph T. Rannazzisi, DC 20590. page at: http://www.archives.gov or the Deputy Assistant Administrator, Office of Mail or hand deliver comments to the Government Printing Office’s Web page Diversion Control. U.S. Department of Transportation, at http://www.gpoaccess.gov/nara. [FR Doc. E7–18531 Filed 9–19–07; 8:45 am] Dockets Management Facility, Room Introduction BILLING CODE 4410–09–P PL–401, 1200 New Jersey Avenue, SE., Washington, DC 20590, or submit Section 1604 of SAFETEA–LU (Pub. electronically at http://dmses.dot.gov/ L. 109–59, 119 Stat. 1144) includes submit or fax comments to (202) 493– provisions related to tolling of highways

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and facilities. Specifically, section 1604 used a variety of electronic and radio the appropriate financial accounting establishes or amends three tolling communications technologies to system and the motorist’s toll account is programs: (1) The Value Pricing Pilot identify accountholders as they traveled debited for the proper toll amount Program; (2) the Express Lanes through toll collection lanes and then without the need for stopping at a toll Demonstration Program; and (3) the charge the appropriate toll against the plaza. Interstate System Construction Toll appropriate account. There was little Although the future will bring new Pilot Program. For each toll program interoperability among the systems, and entrants and new innovation, the under this section, section 1604(b)(6) users had to establish multiple accounts electronic toll collection market has requires the Secretary of Transportation and obtain multiple radio devices in evolved in recent years such that there to promulgate a final rule specifying order to use electronic toll collection on are essentially three de-facto requirements, standards, or performance different toll facilities. ‘‘standards’’ employed in large numbers. specifications for automated toll The various toll agencies in the New (1) The E–ZPass toll device is collection systems. York City area recognized the need to employed on virtually all of the toll Section 1604(b)(6) also requires that allow their users to move among their roads in the mid-Atlantic, northeast in developing the final rule to maximize facilities with a common electronic toll coast, and Illinois with approximately the interoperability of electronic collection technology and formed the 14 million users. This is a proprietary collection systems, the Secretary shall Inter Agency Group (IAG). The IAG device whose intellectual property maximize to the extent practicable three established a common accounting rights are owned by Mark IV Industries other areas: system that would enable users to set up of Toronto, Canada. There are also other (1) Accelerate progress toward the an account with one toll collection proprietary toll collection technologies national goal of achieving a nationwide agency that would be useable across used by smaller numbers of systems and interoperable electronic toll collection multiple toll facilities. In the early users in Texas, Georgia, and Florida. system; 1990s, the IAG coined the term (2) The California Title 21 Electronic (2) Take into account the use of ‘‘E–ZPass’’ as a service mark for its Toll Collection standard is used on the noncash electronic technology currently common electronic toll collection west coast with approximately 2 million deployed within an appropriate system, and selected a vendor that all users. This California specification is an geographical area of travel and the participating agencies would use for ‘‘open’’ standard and currently there are noncash electronic technology likely to electronic tolling applications. The IAG two manufacturers, Transcore and Sirit. be in use within the next five years; and and E–ZPass have grown to include 21 (3) The American Society of Testing (3) Minimize additional costs and agencies in the mid-Atlantic, northeast, Materials (ASTM) V6 standard is used maximize convenience to users of toll and Illinois. Similar efforts to by the trucking industry for the facility and to the toll facility owner or regionalize electronic toll collection electronic clearance of commercial operator. took place in Florida and California, vehicles by both Help Inc.’s Prepass resulting in common toll collection system and by the I–75 Coalition Background technologies for those areas. NorPass system. This is an open States are increasingly turning to As of 2005, there were about 20 standard currently manufactured by tolling as a means of supplementing million electronic toll customers across Raytheon and Mark IV. the country. The largest concentrations traditional methods of roadway National Interoperability financing and enhancing transportation of electronic toll customers are on the mobility. The electronic collection of east coast, with about 17 million users, None of these de-facto standards are these tolls, which began in the mid and on the west coast, with over 2 interoperable with one another. In an 1980s, has grown dramatically over the million users. attempt to achieve interoperability in past 25 years and is expected to grow 1996 and 1997, the DOT encouraged Existing Noncash Electronic Toll and supported the development of a even more over the next decade. The Collection Technologies percentage of toll lanes capable of using single standard for electronic toll Currently, the electronic toll electronic toll collection has grown from collection. The ASTM established a collection systems in any given 36% in 1997 to nearly 80% in 2005.1 standards committee; however, the geographic region typically use similar According to a June 2006 report from companies in the toll market at that time techniques, but are not interoperable could not agree on a single standard that the United States Government from region to region. These existing toll Accountability Office, 23 States have would allow national interoperability. facilities use a communications During that same time frame, the DOT plans to build toll road facilities, technology known as Dedicated Short pursued the examination of a new including 7 States that are planning Range Communications (DSRC). DSRC frequency for DSRC devices that could their first toll roads.2 is a short range microwave radio that is be licensed and thus used for a variety As the toll industry has grown, toll capable of communication with the of transportation applications including agencies have used a variety of toll roadside while a vehicle is moving at electronic toll collection. In 1997, the devices manufactured by various highway speeds. Currently, all DSRC Intelligent Transportation Society of competitive companies. This resulted in devices used for electronic toll America (ITS America), acting on behalf islands of unique proprietary toll collection operate in the unlicensed 902 of the transportation industry, filed a devices throughout the country. The Megahertz (MHz) to 928 MHz band of petition with the Federal early electronic toll collection systems the radio frequency spectrum. Tolls can Communications Commission (FCC) be collected from motorists through a requesting the allocation of 75 MHz of 1 U.S. DOT Intelligent Transportation Systems Joint Program Office, ITS Deployment Statistics device called a ‘‘transponder,’’ which is spectrum at 5.85 Gigahertz (GHz) to Web site, http://www.itsdeployment.its.dot.gov/ about the size of a compact disk or a 5.925 GHz. This allocation was granted Trendsgraph.asp?comp=ETC; 2006. pocket calculator and is installed in a by the FCC in late 1999, and is licensed 2 U.S. Government Accountability Office, Report motorist’s car or truck. The transponder for public safety and private number GAO–06–554, ‘‘Highway Finance: States’ Expanding Use of Tolling Illustrates Diverse communicates via DSRC with a applications. Challenges and Strategies’’ June 2006; http:// ‘‘reader’’ installed over or near the lane As a result of the FCC’s action, the www.gao.gov/new.items/d06554.pdf. of travel. The reader communicates with DOT initiated the support of the

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development of a new set of standards various toll facilities without requiring collection system, the Department does for DSRC at 5.9 GHz. (‘‘5.9 GHz’’ is the multiple accounts. not believe that it can effectively term used to refer to the spectrum Toll plazas and barriers reduce a establish a national standard at this between 5.85 GHz and 5.925 GHz.) The facility’s throughput of vehicles, time. As explained above, the DSRC standards are being developed under the resulting in traffic congestion and its program is conducting tests of prototype auspices of the Institute of Electrical associated hazards as the demand and equipment and open standards for and Electronic Engineers (IEEE). All of volume of vehicles increases. Electronic technical feasibility. These new the current toll device manufacturers in tolling helps to mitigate congestion by standards, when published, may form the United States are participating in the eliminating the bottlenecks caused by the basis of a future rulemaking that development of these open standards toll plazas and barriers. For example, in would establish the standards for a and have agreed upon the electronic 1995, researchers compared vehicle nationwide interoperable electronic toll communications technology to be throughput on lanes with manual toll collection system. However, with employed. In addition, the DOT is collections versus electronic toll respect to this proposal, the Department sponsoring the development of collection on the Tappan Zee Bridge in believes that requiring toll agencies to prototype DSRC equipment to New York. The manual collection lane take interoperability issues into implement the standards under accommodated up to 400–450 vehicles consideration in developing its toll development. The four manufacturers of per hour while an electronic lane collections systems will address the electronic toll collection equipment in peaked at 1000 vehicles per hour.3 Also, objective of the statute to accelerate the United States as of 2005—Mark IV, in another example, the E–ZPass progress toward the goal of nationwide Raytheon, Sirit, and Transcore—united electronic toll collection system saved interoperability in the best way possible to form the DSRC Industry Consortium commuters approximately 2.1 million at the present time. As such, the FHWA to conduct this development. The hours of delay on the New Jersey proposes to require that the toll current DSRC program is conducting Turnpike in 2000.4 Electronic tolling collection agency for any facility tests of prototype equipment and these may also address vehicle safety and operating pursuant to authority under open standards for technical feasibility. property damage concerns associated section 1604 of SAFETEA–LU consult However, even if the technical with toll barriers. The FHWA solicits with the FHWA regarding its proposed communications standards are comments from States, toll authorities, method for electronic toll collection, interoperable technologically, more or other groups that may have and explain how the toll collection must be done to ensure interoperability conducted studies to analyze the effects technique achieves the highest for electronic toll collection. of electronic tolling on safety and reasonable degree of interoperability Specifically, interoperability also property damage. possible with other facilities. The requires ‘‘back-office’’ interoperability, selection and explanation should i.e., properly identifying and accounting DOT Outreach Efforts consider not only current toll collection for electronic toll collection tags. The In preparing this NPRM, the FHWA technologies but also emerging IAG provides this integrated accounting met with representatives of the IBTTA technologies and standards that may service for its members through its to gather technical information and come into use. E–ZPass application. True national insight on its members’ current state-of- Additionally, this proposal would interoperability will require greater practice for electronic toll collection. In require toll agencies to develop exchange of accounting and fiscal addition, IBTTA shared information reasonable methods to enable vehicle information among toll authorities and about activities it has been conducting operators that are not enrolled in an their financial agents. OmniAir, an related to interoperability, including interoperable toll collection program to independent, not-for-profit trade establishing OmniAir as an use the toll facility. Agencies that association created as a result of the independent, not-for-profit trade operate tolling facilities that rely International Bridge, Tunnel and association addressing 5.9 GHz and exclusively on electronic toll collection Turnpike Association’s (IBTTA) 5.9 GHz interoperability. must address how they would DSRC Next Generation Task Force, has accommodate users that have not developed a draft electronic toll General Discussion of the Proposal enrolled in a compatible accounting collection requirements document and This proposal is intended to comply system that provides for the collection is developing a national interoperability with the mandate of section 1604(b)(6) of toll fees for use of the facility. specification for electronic payment of SAFETEA–LU to promulgate a final Lastly, the FHWA recognizes that services. Toll agencies that adopt the rule specifying the requirements, privacy issues may arise in connection OmniAir specifications will be standards, or performance specifications with the implementation, operation, and positioned to provide interoperable for automated toll collection systems enforcement of electronic toll collection services for all toll users. implemented under section 1604. systems, largely as a result of toll tags Development and approval of an open Although the ultimate goal of 1604(b)(6) being linked to an individual’s account technical communications standard will of SAFETEA–LU is to achieve a with a toll agency or transportation be a significant step toward nationally nationwide interoperable electronic toll authority or through alternative interoperable electronic toll collection accommodations. In order to mitigate services. The adoption of an approved 3 Lennon, L. ‘‘Tappan Zee Bridge E–ZPass System this concern, this rulemaking proposes open standard by the DOT for use on all Traffic and Environmental Studies,’’ Paper to require toll agencies to develop, Federal-aid projects and other projects presented at the 64th ITE Annual Meeting: 1995. implement, and make publicly available receiving tolling authority from the DOT ITS Benefits Database Link: privacy policies designed to protect http:www.itsbenefits.its.dot.gov/its/benecost.nsf/0/ will help to accelerate progress toward BFFD6D277991A8C385269610051E2BE. against the inappropriate, unnecessary, national interoperability. Any 4 Operational and Traffic Benefits of E–ZPass to or unauthorized disclosure of any data interoperability test for electronic toll the New Jersey Turnpike, Prepared by the Wilbur that may be collected regarding a user’s collection would need to include not Smith Associates for the New Jersey Turnpike use of an electronic toll collection Authority, New Jersey: August 2001. ITS Benefits only the electronic communications, but Database Link: http://www.itsbenefits.its.dot.gov/ system. These policies would not be also the accounting compatibility its/benecost.nsf/0/ subject to Departmental approval, necessary to allow motorists to use 78B2ACEBB79ED67785256AC0006E29ED. however. The Department solicits

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comments related to the methods or grant an exception to the electronic toll FHWA’s concurrence, the toll agency to means by which privacy concerns can collection requirement for facilities demonstrate to the FHWA how the be balanced with the environmental and granted toll authority under section selected toll collection system achieves congestion reducing advantages of 1604(b) of SAFETEA–LU. This rule the highest reasonable degree of electronic tolling. further requires toll agencies to make interoperability possible with other toll This NPRM applies only to the tolling reasonable accommodations to allow facilities. Additionally, the toll agency programs authorized under section 1604 potential users who may not be enrolled must explain, as provided at section of SAFETEA–LU. The authority to toll in the applicable toll collection program 1604(b)(6)(B)(ii) of SAFETEA–LU, how under a section 1604 program will be to use the facility. Since subsection the toll collection system takes into granted on a case-by-case basis and in 1604(b)(6)(A) states that the account the use of noncash electronic accordance with the criteria listed in interoperability rule be applied for technology currently deployed within statute and this regulation. ‘‘automated toll collection systems an appropriate geographic area of travel, In consideration of the above implemented under this section,’’ which as defined by the toll agency, and discussion, the FHWA requests includes subsections 1604(a), 1604(b), identify the noncash electronic comments on the following questions: and 1604(c), this proposed technology likely to be in use within the (1) How should a national electronic interoperability requirement would next five years in that area. The facility’s toll collection standard be pursued? apply the mandatory use of electronic electronic toll collection system’s design (2) What aspects of electronic toll toll collection to all the programs must include the communications collection should be standardized? authorized under section 1604. requirements between roadside (3) How critical is the timing for Additionally, this section clarifies that a equipment and electronic toll establishing a national electronic toll toll agency may use cash payment transponders, as well as accounting collection standard? methods, such as toll booths, in areas compatibility requirements in order to (4) How should the national standard that are not located in the toll facility’s ensure that users of the toll facilities are incorporate current technologies and lanes of travel if the location and use of properly identified and tolls are charged functions? such methods do not create unsafe to the appropriate account of the user. (5) How should the national standard operating conditions on the toll facility. In section 950.7(d), we propose to allow for changes in technologies over Additionally, this rule would require require all electronic toll collection time? toll agencies to develop and implement systems on any facility that is tolled (6) What are the personal privacy privacy policies to safeguard the pursuant to any of the tolling programs aspects of a national electronic toll disclosure of any data that may be under section 1604 of SAFETEA–LU to collection standard and the technologies collected concerning any user of a toll upgrade to the nationwide that may be used to achieve it? facility operating pursuant to authority interoperability standards if established under a 1604 toll program. The FHWA in a future rulemaking by the FHWA. As Section-by-Section Discussion of the specifically requests comments on the explained above, this proposed rule Proposal privacy implications of this rule and seeks to accelerate progress toward Section 950.1 Purpose potential measures that could be taken nationwide interoperability by requiring to ensure that these privacy interests are any facility that is tolled pursuant to This section states that the proposed protected. authority from any of the toll programs regulations establish interoperability at section 1604 of SAFETEA–LU to Section 950.7 Interoperability requirements, standards, and upgrade its electronic toll collection Requirements performance specifications for facilities system to operate under any nationwide that are granted tolling authority by any This section establishes the proposed standard subsequently established. program authorized under section 1604 requirements for interoperability among In section 950.7(e), we propose to of SAFETEA–LU. electronic tolling systems for agencies or exempt all toll facilities that are facilities that are granted tolling Section 950.3 Definitions currently being tolled under the Value authority by any program authorized Pricing Pilot Program from this The specific terms that have special under section 1604 of SAFETEA–LU. proposed rule. The value pricing significance to agencies or facilities that Because of the differences that may arise program was originally established in are subject to these proposed regulations in defining the potential users of a the section 1012(b) of the Intermodal are defined in this section. facility while maintaining Surface Transportation Efficiency Act of Section 950.5 Requirement To Use interoperability, the FHWA requests 1991 (Pub. L. 102–240). Thus, applying Electronic Toll Collection Technology comments on whether these proposed this rule to electronic toll collection regulations allow for toll agencies to use systems that are already operational This section establishes the proposed different technologies. may be burdensome. However, any requirement that all facilities that are In section 950.7(a), we propose to change to the facility’s toll collection granted tolling authority by any program require the toll agency having system after the effective date of the under section 1604 of SAFETEA–LU jurisdiction over a facility that is tolled final rule would be subject to the must use electronic toll collection pursuant to any of the tolling programs regulations proposed in this rule. systems as the method for collecting under section 1604 of SAFETEA–LU to: tolls from vehicle operators unless the identify the projected users of the Section 950.9 Enforcement toll agency can demonstrate to the facility; and identify the predominant This section discusses remedial FHWA that some other method is either electronic toll collection systems likely actions for agencies or facilities that fail more economically efficient or will utilized by the users of the facility. to comply with the proposed result in a safer operating conditions for In section 950.7(b), we propose to requirements in section 950.7. the facility. However, since section require the toll agency to receive the We propose to suspend the tolling 1604(b)(5) of SAFETEA–LU requires FHWA’s concurrence on its selection of authority of any facility that does not exclusive electronic toll collection for the facility’s electronic toll collection comply with the requirements of this the Express Lanes Demonstration system. In section 950.7(c), we propose rule. However, we would be able to Program, the FHWA is not authorized to to require, in order to receive the extend the tolling authority for any such

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facility if the applicable toll agency authority operates, maintains or allows for multiple types of payment as demonstrates that it is taking the enforces its tolling program. opposed to lanes dedicated to electronic necessary steps to come into compliance It is anticipated that the economic toll collection or barrier-free collection with the regulations. costs of this rulemaking would be techniques. However, the Department minimal while the benefits could be believes that these differences would be Public Meeting significant. These proposed changes are minimal or more than offset by the The public meeting will be held on not anticipated to adversely affect, in a delays caused by current systems. The Thursday, October 11, 2007, at the U.S. material way, any sector of the Department seeks comments on these Department of Transportation economy. Since this proposed rule only issues from both government entities headquarters conference center. The applies to new projects initiated under and the public. meeting will be held from 1:30 p.m. to section 1604 of SAFETEA–LU, no Therefore, this proposed rulemaking 5 p.m. significant encumbrances are added to will result in only minimal costs to the project’s design or implementation. those affected. In addition, these Rulemaking Analyses and Notices Interoperability will afford potential changes would not interfere with any All comments received before the reductions in implementation and action taken or planned by another close of business on the comment operating costs in several ways for both agency and would not materially alter closing date indicated above will be the implementing agencies and the the budgetary impact of any public. First, it will allow the leveraging considered and will be available for entitlements, grants, user fees, or loan of existing resources, specifically the examination in the docket at the above programs. Consequently, a full toll transponders that are being used by address. Comments received before, regulatory evaluation is not required. vehicle operators. By designing for during, and after the comment closing interoperability, the new electronic toll Regulatory Flexibility Act date will be filed in the docket and will collection project will not need to In compliance with the Regulatory be considered to the extent practicable. distribute as many toll transponders as Flexibility Act (Pub. L. 96–354, 5 U.S.C. In addition to late comments, the FHWA it would if it designed a unique toll 601–612) the FHWA has evaluated the will also continue to file relevant collection system. The public users will effects of this proposed action on small information in the docket as it becomes not need to purchase or fund additional entities and has determined that the available, and interested persons should devices and accounts. Second, the proposed action would not have a continue to examine the docket for new operating cost for an electronic toll lane significant economic impact on a material. A final rule may be published is less than one-tenth that of a standard substantial number of small entities. at any time after close of the comment lane. A 1997 report indicated that the This rulemaking does not change the period. Oklahoma Turnpike Authority spent roles or responsibilities of small entities Executive Order 12866 (Regulatory approximately $16,000 per year on the in electronic toll collection projects. The Planning and Review) and DOT operational cost of an electronic toll rulemaking neither improves nor Regulatory Policies and Procedures collection lane. In contrast, the worsens small entities opportunities to Authority spent approximately $176,000 participate in electronic toll collection The FHWA has determined per year to operate a manual toll projects, so results in no economic affect preliminarily that this action would be collection lane. Third, there are also on the small entities. For these reasons, a significant regulatory action within environmental savings as noted above. the FHWA certifies that this action the meaning of Executive Order 12866 Finally, increasing access to electronic would not have a significant economic and would be significant within the toll lanes will decrease time spent impact on a substantial number of small meaning of Department of waiting to pay tolls. For example, entities. Transportation regulatory policies and attended toll collection facilities can procedures. This action is considered Unfunded Mandates Reform Act of process approximately 300 vehicles per 1995 significant because of the substantial hour, or 12 seconds per vehicle. State and local government and public Dedicated electronic toll collection This proposed rule would not impose interest in the requirements for facilities can process approximately unfunded mandates as defined by the automated toll collection systems. This 1,200 vehicles per hour, or 3 seconds Unfunded Mandates Reform Act of 1995 rulemaking proposes interoperability (Pub. L. 104–4, 109 Stat. 48). This per vehicle.5 Using a conservative requirements, standards, and proposed rule will not result in the estimate for a queue of 4 vehicles for performance specifications for toll expenditure by State, local, and tribal processing per lane, the delay for not projects initiated under section 1604 of governments, in the aggregate, or by the using electronic toll collection equals 36 SAFETEA–LU that use electronic toll private sector, of $128.1 million or more seconds. During peak periods, queues collection. Section 1604 of SAFETEA– in any one year (2 U.S.C. 1532). Further, would be longer and delays increased. LU establishes or amends three tolling in compliance with the Unfunded When multiplied by the number of programs: (1) The Value Pricing Pilot Mandates Reform Act of 1995, the transactions, these time savings can be Program, which has a maximum of 15 FHWA will evaluate any regulatory considerable based on the value of $15+ cooperative agreements; (2) the Express action that might be proposed in per hour that an average person in the Lanes Demonstration Program, which subsequent stages of the proceeding to United States earns. While the total has a maximum of 15 tolling projects; assess the effects on State, local, and savings are dependant on how many and (3) the Interstate System tribal governments and the private new systems are built, they could be Construction Toll Pilot Program, which sector. Additionally, the definition of considerable. Costs would be dependent has a maximum of 3 tolling projects. ‘‘Federal Mandate’’ in the Unfunded on the methods that are instituted to This rulemaking only establishes Mandates Reform Act excludes financial collect payments. For example, it may conditions on a Federal grant of assistance of the type in which State, take longer to pay using a lane that authority for toll programs under local, or tribal governments have section 1604 and does not require a 5 Tollways Volume 2, Number 3, by IBTTA, 2005; authority to adjust their participation in State to impose tolls on any particular The Path to Open Road Tolling, by Timothy O. the program in accordance with changes facility nor mandate how a State or toll Gallagher and Harold W. Worrall, pgs. 11–21. made to the program by the Federal

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Government. The Federal-aid highway Protected Property Rights. The FHWA in the heading of this document can be program permits this type of flexibility. does not anticipate that this proposed used to cross reference this action with This rulemaking only establishes action would affect a taking of private the Unified Agenda. conditions on a Federal grant of property or otherwise have taking List of Subjects in 23 CFR Part 950 authority for toll programs under implications under Executive Order section 1604 and does not require a 12630. Communications equipment, State, public authority, or private entity Executive Order 12988 (Civil Justice Electronic products, Highways and designated by a State, to impose tolls on Reform) roads, Motor vehicles, Radio, any particular facility nor mandates Telecommunication, Transportation. how a State or toll authority operates, This action meets applicable Issued on: September 12, 2007. maintains or enforces its tolling standards in sections 3(a) and 3(b)(2) of program. Executive Order 12988, Civil Justice J. Richard Capka, Reform, to minimize litigation, Federal Highway Administrator. Executive Order 13132 (Federalism eliminate ambiguity, and reduce Assessment) In consideration of the foregoing, the burden. FHWA proposes to add a new part 950 This proposed action has been Executive Order 13045 (Protection of to title 23, Code of Federal Regulations, analyzed in accordance with the Children) to read as follows: principles and criteria contained in Executive Order 13132, and the FHWA We have analyzed this rule under PART 950—ELECTRONIC TOLL has determined that this proposed Executive Order 13045, Protection of COLLECTION action would not have sufficient Children from Environmental Health federalism implications to warrant Risks and Safety Risks. The FHWA Sec. consultation with the States. The FHWA certifies that this proposed action would 950.1 Purpose. 950.3 Definitions. has also determined that this proposed not cause any environmental risk to health or safety that might 950.5 Requirement to use electronic toll action would not preempt any State law collection technology. or State regulation or affect the States’ disproportionately affect children. 950.7 Interoperability requirements. ability to discharge traditional State Executive Order 13175 (Tribal 950.9 Enforcement. governmental functions. Consultation) Authority: 23 U.S.C. 109, 315; sec. Executive Order 12372 The FHWA has analyzed this action 1604(b)(5) and (b)(6), Pub. L. 109–59, 119 Stat. 1144; 49 CFR 1.48. (Intergovernmental Review) under Executive Order 13175, dated Catalog of Federal Domestic November 6, 2000, and believes that the § 950.1 Purpose. Assistance Program Number 20.205, proposed action would not have The purpose of this part is to establish Highway Planning and Construction. substantial direct effects on one or more interoperability requirements, The regulations implementing Executive Indian tribes; would not impose standards, and performance Order 12372 regarding substantial direct compliance costs on specifications for toll facilities that are intergovernmental consultation on Indian tribal governments; and would tolled under section 1604 of the Safe, Federal programs and activities do not not preempt tribal laws. The proposed Accountable, Flexible, Efficient apply to this program. Accordingly, the rulemaking addresses interoperability Transportation Equity Act: A Legacy for FHWA solicits comments on this issue. requirements, standards, or performance specifications for toll projects initiated Users (SAFETEA–LU) (Pub. L. 109–59; Paperwork Reduction Act under section 1604 of SAFETEA–LU 119 Stat. 1144) that use electronic toll Under the Paperwork Reduction Act that use electronic toll collection and collection. of 1995 (PRA) (44 U.S.C. 3501, et seq.), would not impose any direct § 950.3 Definitions. Federal agencies must obtain approval compliance requirements on Indian from the Office of Management and tribal governments. 1604 toll program refers to any of the Budget (OMB) for each collection of tolling programs authorized under Executive Order 13211 (Energy Effects) information they conduct, sponsor, or section 1604 of SAFETEA–LU. These require through regulations. The FHWA We have analyzed this action under programs include the Value Pricing has determined that this proposal does Executive Order 13211, Actions Pilot Program, the Express Lanes not contain collection of information Concerning Regulations That Demonstration Program, and the requirements for the purposes of the Significantly Affect Energy Supply, Interstate System Construction Toll PRA. Distribution, or Use dated May 18, 2001. Pilot Program. We have determined that this is not a National Environmental Policy Act Dedicated short-range significant energy action under that communications means a microwave The agency has analyzed this order since it is not likely to have a radio that is capable of short-range proposed action for the purpose of the significant adverse effect on the supply, communication with the roadside while National Environmental Policy Act of distribution, or use of energy. Therefore, a vehicle is moving at highway speeds. 1969 (42 U.S.C. 4321) and has a Statement of Energy Effects is not Electronic toll collection means the determined that this proposed action required. ability for vehicle operators to pay tolls would not have any effect on the quality Regulation Identification Number without stopping their vehicles through of the environment. A regulation identification number the use of dedicated short-range Executive Order 12630 (Taking of (RIN) is assigned to each regulatory communications between onboard Private Property) action listed in the Unified Agenda of vehicle and roadside devices. The FHWA has analyzed this Federal Regulations. The Regulatory Toll agency means the relevant public proposed rule under Executive Order Information Service Center publishes or private entity or entities to which toll 12630, Governmental Actions and the Unified Agenda in April and authority has been granted for a facility Interface with Constitutionally October of each year. The RIN contained under a 1604 toll program.

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§ 950.5 Requirement to use electronic toll electronic technology currently SUMMARY: This document cancels a collection technology. deployed within an appropriate public hearing on proposed regulations (a) Any toll agency operating a toll geographic area of travel (as defined by under section 199 of the Internal facility pursuant to authority under a the toll agency) and identify the Revenue Code. These regulations 1604 toll program shall use an noncash electronic technology likely to involve the deduction for income electronic toll collection system as the be in use within the next five years in attributable to domestic production method for collecting tolls from vehicle that area. The facility’s toll collection activities under section 199 and affect operators for the use of the facility system’s design shall include the taxpayers who produce qualified films unless the toll agency can demonstrate communications requirements between under section 199(c)(4)(A)(i)(II) and to the FHWA that some other method is roadside equipment and toll (c)(6) and taxpayers who are members of either more economically efficient or transponders, as well as accounting an expanded affiliated group under will make the facility operate more compatibility requirements in order to section 199(d)(4). safely. If a facility is collecting tolls ensure that users of the toll facilities are DATES: The public hearing, originally pursuant to section 1604(b) of properly identified and tolls are charged scheduled for October 2, 2007, at 10 SAFETEA–LU, the toll agency shall to the appropriate account of the user. a.m., is cancelled. only use electronic toll collection (d) A toll agency that operates any toll FOR FURTHER INFORMATION CONTACT: systems. Nothing in this subsection facility pursuant to authority under a Richard A. Hurst of the Publications and shall prevent a toll agency from using 1604 toll program must upgrade its toll Regulations Branch, Legal Processing cash payment methods, such as toll collection system to meet any applicable Division, Associate Chief Counsel booths, in areas that are not located in standards and interoperability tests that (Procedure and Administration), at the toll facility’s lanes of travel if the have been officially adopted through [email protected]. location and use of such methods do not rulemaking by the FHWA. create unsafe operating conditions on (e) With respect to facilities that are SUPPLEMENTARY INFORMATION: A notice the toll facility. tolled pursuant to the Value Pricing of public hearing that appeared in the (b) A toll agency using electronic toll Pilot Program, this part only applies if Federal Register on Thursday, June 7, collection technology must develop and tolls are imposed on a facility after the 2007 (72 FR 31478), announced that a implement reasonable methods to effective date of this rule. However, public hearing was scheduled for enable vehicle operators that are not such facility is subject to this part if the October 2, 2007, at 10 a.m., in the IRS enrolled in a toll collection program that facility’s toll collection system is Auditorium, Internal Revenue Building, is interoperable with the toll collection changed or upgraded after the effective 1111 Constitution Avenue, NW., system of the relevant toll facility to use date of the regulations in this part. Washington, DC. The subject of the the facility. public hearing is under section 199 of (c) A toll agency using electronic toll § 950.9 Enforcement. the Internal Revenue Code. collection technology must develop, (a) The tolling authority of any facility The public comment period for these implement, and make publicly available operating pursuant to authority under a regulations expired on September 5, privacy policies to safeguard the 1604 toll program shall be suspended in 2007. The notice of proposed disclosure of any data that may be the event the relevant toll agency is not rulemaking and notice of public hearing collected through such technology in compliance with this part within six instructed those interested in testifying concerning any user of a toll facility (6) months of receiving a written notice at the public hearing to submit a request operating pursuant to authority under a of non-compliance from FHWA. If the to speak and an outline of the topics to 1604 toll program, but is not required to toll agency demonstrates that it is taking be addressed. As of Tuesday, September submit such policies to FHWA for the necessary steps to come into 11, 2007, no one has requested to speak. approval. compliance within a reasonable period Therefore, the public hearing scheduled of time, FHWA shall extend such tolling for October 2, 2007, is cancelled. § 950.7 Interoperability requirements. authority. LaNita Van Dyke, (a) For any toll facility operating (b) The FHWA may take other action pursuant to authority under a 1604 toll as may be appropriate, including action Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief program, the toll agency shall— pursuant to § 1.36 of this title. (1) Identify the projected users of the Counsel (Procedure and Administration). facility; and [FR Doc. E7–18529 Filed 9–19–07; 8:45 am] [FR Doc. E7–18507 Filed 9–19–07; 8:45 am] (2) Identify the predominant toll BILLING CODE 4910–22–P BILLING CODE 4830–01–P collection systems likely utilized by the users of the facility. (b) Based on the identification DEPARTMENT OF THE TREASURY DEPARTMENT OF THE TREASURY conducted under subsection (a), the toll agency shall receive the FHWA’s Internal Revenue Service Alcohol and Tobacco Tax and Trade concurrence on the proposal for the Bureau facility’s toll collection system’s 26 CFR Part 1 27 CFR Parts 4, 5, 7, and 24 standards and design. [REG–103842–07] (c) In requesting the FHWA’s concurrence, the toll agency shall RIN 1545–BG33 [Notice No. 75; Re: Notice No. 73] demonstrate to the FHWA that the selected toll collection system and Qualified Films Under Section 199; RIN 1513–AB07 Correction technology achieves the highest Labeling and Advertising of Wines, reasonable degree of interoperability AGENCY: Internal Revenue Service (IRS), Distilled Spirits and Malt Beverages; possible with other toll facilities. The Treasury. Comment Period Extension toll agency shall also explain to the ACTION: Cancellation of notice of public FHWA how the toll collection system AGENCY: Alcohol and Tobacco Tax and hearing on proposed rulemaking. takes into account the use of noncash Trade Bureau, Treasury.

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ACTION: Notice of proposed rulemaking; American wineries to extend the DATES: The public comment period for extension of comment period. comment period for an additional 90 this proposed rule is extended until days beyond the October 29, 2007 October 26, 2007. SUMMARY: In response to an industry closing date. In support of their ADDRESSES: Submit your comments, member request, the Alcohol and extension request, Wine America Tobacco Tax and Trade Bureau extends identified by docket number EPA–R09– indicates that the wine industry is now OAR–2006–0583, by one of the the comment period for Notice No. 73, entering the grape harvest season, which Labeling and Advertising of Wines, following methods: is its busiest time of the year. They (1) Federal eRulemaking portal: Distilled Spirits, and Malt Beverages, a further note that because of this, wine notice of proposed rulemaking http://www.regulations.gov. industry members would not have (2) E-mail: [email protected]. published in the Federal Register on adequate time to address the rulemaking July 31, 2007, for an additional 90 days. (3) Mail or deliver: Doris Lo (AIR–2), comment request in a comprehensive U.S. Environmental Protection Agency DATES: Written comments must be manner. received on or before January 27, 2008. Region IX, 75 Hawthorne Street, San In response to this request, TTB Francisco, CA 94105–3901. ADDRESSES: extends the comment period for Notice You may send comments on Instructions: All comments will be No. 73 for an additional 90 days. this notice to one of the following included in the public docket without Therefore, comments on Notice No. 73 addresses: change and may be made available • http://www.regulations.gov (Federal are now due on or before January 27, online at www.regulations.gov, e-rulemaking portal; follow the 2008. including any personal information instructions for submitting comments); Drafting Information provided, unless the comment includes or Confidential Business Information (CBI) • Director, Regulations and Rulings Lisa M. Gesser of the Regulations and or other information whose disclosure is Division, Alcohol and Tobacco Tax and Procedures Division drafted this notice. restricted by statute. Information that Trade Bureau, P.O. Box 14412, Signed: September 10, 2007. you consider CBI or otherwise protected Washington, DC 20044–4412. John J. Manfreda, You may view copies of this notice, should be clearly identified as such and Administrator. Notice No. 73, and any comments we should not be submitted through the receive about the proposals described in [FR Doc. E7–18510 Filed 9–19–07; 8:45 am] www.regulations.gov or e-mail. Notice No. 73 under the appropriate BILLING CODE 4810–31–P www.regulations.gov is an anonymous docket number on the Regulations.gov access system, and EPA will not know Web site at http://www.regulations.gov. your identity or contact information A link to the Regulations.gov Web site unless you provide it in the body of ENVIRONMENTAL PROTECTION your comment. If you send e-mail is also available on the TTB Web site at AGENCY http://www.ttb.gov/regulations_laws/ directly to EPA, your e-mail address will be automatically captured and all_rulemaking.shtml. In addition, you 40 CFR Parts 52 and 81 may view copies of the same materials included as part of the public comment. described above by appointment at the [EPA–R09–OAR–2006–0583; FRL–8470–9] If EPA cannot read your comment due TTB Information Resource Center, 1310 to technical difficulties and cannot G Street, NW., Washington, DC 20220. Extension of Public Comment Period contact you for clarification, EPA may To make an appointment, telephone for Proposed Rule on Approval and not be able to consider your comment. (202) 927–2400. Promulgation of Implementation Plans; Docket: The index to the docket for Designation of Areas for Air Quality this action is available electronically at FOR FURTHER INFORMATION CONTACT: Lisa www.regulations.gov and in hard copy M. Gesser, Regulations and Rulings Planning Purposes; State of California; PM–10; Affirmation of Determination of at EPA Region IX, 75 Hawthorne Street, Division, Alcohol and Tobacco Tax and San Francisco, California. While all Trade Bureau, P.O. Box 128, Morganza, Attainment for the San Joaquin Valley Nonattainment Area documents in the docket are listed in MD 20660; telephone (301) 290–1460; or the index, some information may be Joanne C. Brady, Regulations and AGENCY: Environmental Protection publicly available only at the hard copy Rulings Division, Alcohol and Tobacco Agency (EPA). location (e.g., copyrighted material), and Tax and Trade Bureau, P.O. Box 45797, ACTION: Extension of public comment some may not be publicly available in Philadelphia, PA 19149; telephone (215) period. either location (e.g., CBI). To inspect the 333–7050. hard copy materials, please schedule an SUPPLEMENTARY INFORMATION: On July SUMMARY: The EPA is announcing an appointment during normal business 31, 2007, The Alcohol and Tobacco Tax extension of the public comment period hours with the contact listed directly and Trade Bureau (TTB) published for the proposed rule entitled ‘‘Approval below. Notice No. 73, Labeling and Advertising and Promulgation of Implementation of Wines, Distilled Spirits, and Malt Plans; Designation of Areas for Air FOR FURTHER INFORMATION CONTACT: Beverages, in the Federal Register (72 Quality Planning Purposes; State of Doris Lo, EPA Region IX, (415) 972– FR 41860). In that notice of proposed California; PM–10; Affirmation of 3959, [email protected]. rulemaking, TTB requests public Determination of Attainment for the San SUPPLEMENTARY INFORMATION: The comment on possible changes to the Joaquin Valley Nonattainment Area.’’ proposed rule was signed by the labeling and advertising requirements of The proposed rule was initially Regional Administrator on August 15, alcohol beverage products regulated by published in the Federal Register on 2007 and published in the Federal TTB. When published, the comment August 27, 2007. Written comments on Register on August 27, 2007 (72 FR period for TTB Notice No. 73 was the proposed rule were to be submitted 49046). EPA has received a request for scheduled to close on October 29, 2007. to EPA on or before September 26, 2007 an additional 30 days to comment on After the publication of Notice No. 73, (a 30-day comment period). The EPA is the proposed rule and is granting that TTB received a request from Wine extending the public comment period request. Therefore EPA is extending the America, a national association of until October 26, 2007. comment period until October 26, 2007.

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Dated: September 13, 2007. migrated to the FDMS. This work is efficient, longer-lasting, and renewable Laura Yoshii, being done as part of a larger project to power source for electrically operated Acting Regional Administrator, Region 9. consolidate the federal rulemaking equipment. Fuel cells are designed to [FR Doc. E7–18586 Filed 9–19–07; 8:45 am] docket systems. Please note the FDMS is replace, augment, or recharge existing BILLING CODE 6560–50–P significantly different from the DOT battery sources. Various types of fuels DMS and may assign a new docket may be used in fuel cell systems, number to each existing docket. Follow including but not limited to gases meeting the criteria for classification as DEPARTMENT OF TRANSPORTATION the instructions specific to each docket Web site for submitting comments. On Division 2.1 (flammable gases), solids Pipeline and Hazardous Materials December 31, 2007, the DOT DMS will meeting the criteria for classification as Safety Administration be permanently decommissioned. Division 4.3 (dangerous when wet), and • Fax: 1–202–493–2251. liquids meeting the criteria for • 49 CFR Parts 171, 173, and 175 Mail: Docket Operations, U.S. classification as Class 3 (flammable) or Department of Transportation, West Class 8 (corrosive) material. Specific [Docket No. PHMSA–2006–25446 (HM–243)] Building, Ground Floor, Room W12– materials used in fuel cells include RIN 2137–AE19 140, Routing Symbol M–30, 1200 New methanol and other types of flammable Jersey Avenue, SE., Washington, DC liquids, butane, hydrogen in metal Hazardous Materials: Fuel Cell 20590. hydride, borohydrides, and formic acid. • Hand Delivery: To Docket Cartridges and Systems Transported II. Current HMR Requirements Operations, Room W12–140 on the on Board Passenger Aircraft in Carry- Applicable to the Transportation of ground floor of the West Building, 1200 on Baggage Fuel Cells New Jersey Avenue, SE., Washington, AGENCY: Pipeline and Hazardous DC 20590, between 9 a.m. and 5 p.m., Under the Hazardous Materials Materials Safety Administration Monday through Friday, except Federal Regulations (HMR; 49 CFR parts 171– (PHMSA), Department of Transportation Holidays. 180), fuel cells generally must be (DOT). • Federal eRulemaking Portal: Go to transported in accordance with ACTION: Notice of proposed rulemaking http://www.regulations.gov. Follow the requirements applicable to the material (NPRM). online instructions for submitting they contain. Thus, a fuel cell comments. containing a corrosive material must SUMMARY: PHMSA is proposing to Instructions: All submissions must conform to the packaging and hazard amend the Hazardous Materials include the agency name and docket communication requirements applicable Regulations (HMR) to permit certain number or Regulatory Identification to that corrosive material when offered fuel cell cartridges and fuel cell systems Number (RIN) for this notice. For for transportation. After careful designed for portable electronic devices detailed instructions on submitting evaluation of possible transportation to be transported by passengers and comments and additional information safety risks, PHMSA adopted packaging, crew in carry-on baggage on board on the rulemaking process, see the testing, and hazard communication passenger-carrying aircraft. The Public Participation heading of the requirements for transporting fuel cell proposed rule would cover fuel cells Supplementary Information section of systems and fuel cell cartridges containing certain hazardous materials this document. Note that all comments containing flammable liquids, including (flammable liquids, including methanol; received will be posted without change methanol or methanol and water formic acid; certain borohydride to the docket management system, solutions, as cargo by all modes (final materials; or butane) and meeting including any personal information rule published December 29, 2006; 71 certain performance and consumer use provided. Please see the Privacy Act FR 7896). The HMR requirements are standards, which we are proposing to heading under SUPPLEMENTARY consistent with international incorporate by reference into the HMR. INFORMATION. transportation standards applicable to We have evaluated the possible Docket: For access to the dockets to the transportation of fuel cell cartridges transportation safety risks presented by read background documents or and systems containing flammable these fuel cell cartridges and systems comments received, go to http:// liquids in the 14th Revised Edition of and have determined they may safely be dms.dot.gov, and after September 28, the UN Recommendations on the transported in the cabin of a passenger- 2007, to http://www.regulations.gov at Transport of Dangerous Goods (UN carrying aircraft. any time or to Docket Operations, U.S. Recommendations). DATES: Written comments should be Department of Transportation (see III. International Standards Applicable submitted on or before November 19, ADDRESSES). to the Transportation of Fuel Cells 2007. FOR FURTHER INFORMATION CONTACT: The International Civil Aviation ADDRESSES: You may submit comments Eileen Edmonson, Office of Hazardous Organization (ICAO) adopted provisions identified by the docket number Materials Standards, (202) 366–8553, for transporting fuel cell systems and (PHMSA–2006–25446 (HM–243) by any Pipeline and Hazardous Materials Safety fuel cell cartridges containing of the following methods: Administration (PHMSA) 1200 New flammable liquid as cargo on board • Web site: Until September 27, 2007, Jersey Avenue, SE., Washington, DC aircraft in the 2007–2008 edition of the electronic submissions to the DOT 20590, facsimile telephone number ICAO Technical Instructions for the Safe Docket Management System (DMS), (202) 366–7435, or by e-mail to Transport of Dangerous Goods by Air located at http://dms.dot.gov. Starting [email protected]. (ICAO Technical Instructions). These on September 28, 2007, all electronic SUPPLEMENTARY INFORMATION: provisions are consistent with those for submissions must be made to the fuel cell systems and cartridges in the Federal Docket Management System’s I. Background UN Recommendations. At that time, (FDMS) eRulemaking Portal located at Fuel cell cartridges and fuel cell ICAO also adopted under Section 8; http://www.regulations.gov, and the systems are an emerging energy 1.1.2(r) provisions for transporting fuel information in the DOT DMS will be technology developed to provide a more cell systems and cartridges containing

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flammable liquids (including methanol), IV. Flammable Gas (Butane) and cartridges containing Class 8 formic acid, and butane, in carry-on Leakage Criteria borohydride materials to be transported baggage on board passenger-carrying In our technical evaluation for this by passengers and crew in carry-on aircraft under certain conditions. This NPRM, PHMSA, in coordination with baggage on board passenger-carrying passenger carry-on authorization applies the Federal Aviation Administration’s aircraft (Petition No. P–1483). Medis to fuel cell cartridges with a maximum (FAA’s) William J. Hughes Technical Technologies and Millennium Cell quantity of 200 ml (6.76 ounces) for Center (FAA Tech Center), conducted assert that Class 8 borohydride materials liquids, 200 ml (6.76 ounces) for metal an additional examination specific to present the same risks in transportation fuel cell cartridges containing butane, the design type testing criteria for fuel as formic acid, also a Class 8 material. Both petitions may be viewed until and 120 ml (4.1 ounces) for non-metallic cell cartridges containing liquefied September 27, 2007, in the DMS docket fuel cell cartridges containing butane. flammable gas (butane). This evaluation for this rulemaking at http:// No more than two spare fuel cell concluded that the industry technical dms.dot.gov, and beginning on cartridges are allowed per passenger. specification developed to govern the September 28, 2007, in the FDMS design and use of fuel cell cartridges One of the conditions for the docket for this rulemaking at http:// and systems, IEC/PAS 62282–6–1, passenger authorization in the ICAO www.regulations.gov. Technical Instructions is that the fuel required amendment to ensure fuel cells cell systems and cartridges must containing a flammable gas are designed VI. Proposals in This NPRM conform to the industry technical and tested to a standard that is In this NPRM, we are proposing to equivalent to the safety standard specification governing the design and permit the transportation in carry-on established for certain non-bulk gas consumer use of fuel cell cartridges, baggage on passenger-carrying aircraft of packagings in the HMR. power units, and power systems fuel cell cartridges and systems Based on the PHMSA and FAA containing Class 3 flammable liquids, developed by the IEC. The IEC evaluations, the ICAO Dangerous Goods Specification No. IEC/PAS 62282–6–1 including methanol; formic acid and Panel at its Working Group 2006 borohydride materials meeting the First Edition, with Technical meeting (October 25–November 3, 2006) Corrigendum 1, 2006, addresses fuel cell definition for a Class 8 material; and recommended that the IEC amend its butane, a Division 2.1 gas. As proposed systems with outputs that do not exceed fuel cell specification to mandate a zero- in this NPRM, the fuel cells must 60 volts and 240 watts. The IEC leak standard as a basis for successfully conform to certain performance criteria. specification provides detailed passing the design-type tests. This zero- The proposals in this NPRM are manufacturing, safety, and testing leak standard would be demonstrated by consistent with the passenger requirements to address use, misuse, subjecting the cartridge test sample to a authorizations adopted for the 2007– and consumer transportation. To ensure water bath test (consistent with Section 2008 edition of the ICAO Technical the capability of the fuel cell and 6.2.4.1 of the UN Recommendations) Instructions. cartridge to withstand normal after each design type test. The IEC Based on our assessment to date, we conditions of consumer handling and revised its test protocols and acceptance agree with the U.S. Fuel Cell Council transportation, the specification requires criteria and issued an addendum that fuel cell cartridges and systems various design type tests such as (included in this docket) to the IEC PAS containing flammable liquids, formic pressure differential, vibration, 62282–6–1 on April 18, 2007, published acid, and butane do not pose an temperature cycling, high temperature as ‘‘IEC/PAS 62282–6–1 First Edition, unreasonable safety risk when carried exposure, drop, compressive loading, with Technical Corrigendum 1, 2006.’’ on board aircraft by passengers and connection cycling, external short The IEC plans to continue to review this crew members, provided they meet the circuit, and long-term storage. standard for possible improvements. specified performance standards. We Members of the fuel cell industry and PHMSA will monitor further also agree with Medis Technologies and the IEC prepared and submitted developments to the standard and, Millennium Cell that fuel cell cartridges proposals (included in this docket) to subject to technical review, may and systems containing borohydride propose to adopt a later version in a the ICAO Dangerous Goods Panel that materials pose similar safety risks and subsequent rulemaking. the Panel considered in making its will operate in a similar manner as those containing formic acid. decision to permit certain fuel cell V. Petitions for Rulemaking It is important to note, however, that systems and cartridges to be transported On March 2, 2006, the U.S. Fuel Cell we are continuing to work with the FAA by passengers on board aircraft Council petitioned PHMSA to permit Tech Center to evaluate the safety risks beginning on January 1, 2007. The airline passengers and crew to transport posed by the air transportation of fuel proposals provide an assessment of the fuel cell systems and cartridges in carry- cell cartridges and systems containing benefits and risks associated with on baggage (Petition No. P–1475). In its various types and classes of hazardous transporting fuel cell systems and petition, the U.S. Fuel Cell Council materials. We expect to conclude this cartridges containing butane, formic requests that PHMSA revise § 175.10 to evaluation prior to issuing a final rule acid, methanol, hydrogen stored in permit portable electronic devices, such under this docket; it will be placed in metal hydrides, and sodium as cameras, laptop computers, and the docket for this rulemaking. borohydride-based and potassium hand-held audio devices, powered by As indicated above, we are proposing borohydride-based fuels. PHMSA fuel cell systems and cartridges to require fuel cell cartridges and conducted its own independent containing flammable liquid, formic systems to meet rigorous performance technical assessment of the safety risks acid, or butane to be transported by criteria that are consistent with the associated with each of the proposed passengers and crew on passenger- conditions applicable to the passenger fuel cell system and cartridge carrying aircraft under the conditions authorization in the ICAO Technical technologies; based on this evaluation, adopted by ICAO. On August 23, 2006, Instructions. First, we are proposing to PHMSA supported the passenger Medis Technologies, Ltd., and incorporate into the HMR the industry provisions adopted in the ICAO Millennium Cell, Inc., petitioned technical specification and addendum Technical Instructions. PHMSA to permit fuel cell systems and developed by the IEC governing the

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design and consumer use of fuel cell VII. Transportation Security 2. Section 5120 of Federal hazardous cartridges, power units, and power Administration materials transportation law (49 U.S.C. systems (IEC/PAS 62282–6–1 First The Department of Homeland 5120), authorizes the Secretary of Edition, with Technical Corrigendum 1, Security’s Transportation Security Transportation to participate in the 2006). The IEC technical specification is Administration (TSA) is authorized to development of international standards a comprehensive standard that prescribe security standards for all for the transportation of hazardous addresses design, manufacturing, modes of transportation, including materials and grants the Secretary broad testing, and transportation specific to aviation (49 U.S.C. 114(d)). Under this discretion to harmonize the HMR with micro-fuel cells. It prescribes authority, TSA prohibits airline international standards. Section 5120(c) requirements for valves, filling, passengers from carrying weapons, permits the Secretary to establish more packaging performance, failure mode explosives, or incendiary devices and stringent standards for transportation in analysis, consumer refilling, materials of has published several interpretative the United States as necessary in the construction, exterior and exhaust rules to provide guidance on the types public interest. The proposals in this temperature limits, warnings, of property TSA considers subject to the NPRM would harmonize the HMR with certification, markings, and prohibition (68 FR 7444; 68 FR 9902; 70 international requirements for fuel cell manufacturers’ instructions. As revised FR 9877). systems and cartridges to the extent by the recent addendum, the IEC As PHMSA developed this NPRM, we these are consistent with PHMSA’s specification mandates a zero-leak consulted with TSA concerning current safety objectives. standard as a basis for successfully security limitations applicable to the B. Executive Order 12866 and DOT passing the design-type tests and, thus, carriage of fuel cells by aircraft Regulatory Policies and Procedures is equivalent to the safety standard passengers and crew members and This proposed rule is not a significant established for certain non-bulk gas shared with TSA our technical analysis regulatory action under section 3(f) of packagings in the HMR. We also supporting this rulemaking. We Executive Order 12866 and was not propose to limit fuel cell cartridges and understand that TSA is considering reviewed by the Office of Management systems carried by airline passengers whether any additional security and Budget. This NPRM is a non- and crew to those marked ‘‘APPROVED measures for fuel cells or fuel cell significant rule under the Regulatory FOR CARRIAGE IN AIRCRAFT CABIN systems may be appropriate. In any Policies and Procedures of the ONLY’’ by the manufacturer. This case, this rulemaking would not limit Department of Transportation [44 FR marking is the manufacturer’s TSA’s authority to address security 11034]. certification that the fuel cell cartridges concerns related to the transportation of Fuel cells are an emerging technology and systems conform to the performance fuel cells or fuel cell systems. designed to meet the growing demand standard established in the revised IEC On September 26, 2006, TSA imposed for alternative energy sources. Fuel cell technical specification. a strict limit on liquids, gels, and technology has not yet achieved wide- In addition, in this NPRM, we are aerosols an aircraft passenger is spread commercialization, but is being proposing to limit the amount of permitted to take through a security developed for use in mobile phones, hazardous material that may be checkpoint in carry-on baggage. TSA laptop computers, and, to a lesser contained in each individual fuel cell limits these materials to 3-ounce (100 extent, camcorders, digital cameras, and authorized for transportation in carry-on mL) or smaller containers placed in a personal digital assistants (‘‘PDAs’’). baggage on board passenger-carrying clear quart-size, zip-top plastic bag. Fuel The U.S. Fuel Cell Council found, as a aircraft. Consistent with the standard cell cartridges and systems would be result of its 2006 survey of 181 industry adopted for the ICAO Technical subject to this limitation, respondents, that sales from 2005 to Instructions, we propose to limit fuel notwithstanding any rule adopted in 2006 of all fuel cell and fuel cell-based cells containing liquid fuels to 200 mL this proceeding. systems, of which those designed for (6.76 ounces) of fuel per cartridge, fuel VIII. Rulemaking Analyses and Notices portable electronic devices are currently cells containing liquefied gases to 200 a small part, increased by 7 percent to mL (6.76 ounces) of fuel per metal A. Statutory/Legal Authority for This $353 million, and research and cartridge and 120 mL (4 fluid ounces) of Rulemaking development expenditures and industry fuel per non-metallic fuel cell cartridge, This notice of proposed rulemaking is employment over the same period and fuel cells containing solid materials published under the following statutory increased by 11 and 12 percent to $796 to 200 g (7 ounces) of fuel per cartridge. authorities: million and 7,074 employees, Also consistent with the ICAO 1. 49 U.S.C. 5103(b) authorizes the respectively. The industry projects fuel Technical Instructions, each passenger Secretary of Transportation to prescribe cells for portable electronic devices will or crew member would be permitted to regulations for the safe transportation, achieve significant market penetration carry up to two spare cartridges. including security, of hazardous by 2009. To reduce possible releases, we material in intrastate, interstate, and By proposing to authorize their propose to prohibit passengers and crew foreign commerce. This NPRM proposes carriage by airline passengers and crew, members from refilling fuel cell regulations to promote the safe the regulatory changes addressed in this cartridges and systems, except to install transportation of fuel cells carried by rulemaking will lift barriers to the a spare cartridge. In addition, we airline passengers and crew members. commercialization and distribution of propose to limit fuel cell cartridges and To this end, as detailed above, PHMSA fuel cell cartridges for use in personal systems carried by passengers and crew proposes to limit the types and electronic equipment. The costs members to a type and design that will quantities of fuel cell cartridges and fuel associated with this rulemaking not continue to charge batteries when cell systems permitted on passenger proposal primarily relate to the costs for the device being powered is not in use. aircraft, prescribe specific performance- testing fuel cell designs in accordance Again, these prohibitions are consistent based design and packaging criteria for with the IEC consensus standard. We with the passenger authorizations for these articles, and limit the manner in expect most fuel cell manufacturers will fuel cells adopted under the ICAO which they may be used during air voluntarily comply with the IEC Technical Instructions. transportation. standard as a positive marketing tool

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because it addresses broad consumer have tribal implications and does not is the least burdensome alternative that safety issues and provides independent impose substantial direct compliance achieves the objective of the rule. assurance that fuel cells will meet a costs, the funding and consultation I. Environmental Assessment rigorous safety standard. Thus, the requirements of Executive Order 13175 incremental costs imposed by this do not apply. The National Environmental Policy NPRM are expected to be minimal. Act (NEPA), §§ 4321–4375, requires that E. Regulatory Flexibility Act federal agencies analyze proposed C. Executive Order 13132 The Regulatory Flexibility Act (5 actions to determine whether the action This proposed rule has been analyzed U.S.C. 601 et seq.) requires an agency to will have a significant impact on the in accordance with the principles and review regulations to assess their impact human environment. The Council on criteria set forth in Executive Order on small entities, unless the agency Environmental Quality (CEQ) 13132 (‘‘Federalism’’). Any rule determines the rule is not expected to regulations order federal agencies to resulting from this rulemaking will have a significant impact on a conduct an environmental review preempt State, local, and Indian tribe substantial number of small entities. considering (1) the need for the requirements but will not have The proposed rule will relax regulatory proposed action, (2) alternatives to the substantial direct effects on the States, barriers to the transportation of fuel proposed action, (3) probable the relationship between the national cells used in personal electronic devices environmental impacts of the proposed government and the States, or the and, accordingly, is expected to have a action and alternatives, and (4) the distribution of power and positive impact on small businesses that agencies and persons consulted during responsibilities among the various manufacture, distribute, transport, or the consideration process. 40 CFR levels of government. Therefore, the use such items. As indicated above, we 1508.9(b). consultation and funding requirements expect the incremental costs imposed by Purpose and Need of Executive Order 13132 do not apply. this NPRM to be minimal. Therefore, I Fuel cells are an emerging energy Federal hazardous materials certify that, if adopted, the proposals in technology designed to replace, transportation law (49 U.S.C. 5125(b)) this NPRM will not have a significant augment, or recharge existing battery expressly preempts State, local, and impact on a substantial number of small sources. The fuel cell designs currently Indian tribe requirements on certain entities. under development are powered by one covered subjects, as follows: This proposed rule has been (1) The designation, description, and of a variety of hazardous materials fuels, developed in accordance with Executive including methanol and other types of classification of hazardous materials; Order 13272 (‘‘Proper Consideration of (2) The packing, repacking, handling, flammable liquids, butane flammable Small Entities in Agency Rulemaking’’) labeling, marking, and placarding of gas, dangerous when wet hydrogen in and DOT’s procedures and policies to hazardous materials; metal hydride, and corrosive liquids (3) The preparation, execution, and promote compliance with the containing formic acid or borohydride use of shipping documents related to Regulatory Flexibility Act to ensure that materials. hazardous materials, and requirements potential impacts of draft rules on small The HMR and the ICAO Technical related to the number, contents, and entities are properly considered. Instructions already include provisions placement of those documents; F. Paperwork Reduction Act for transporting fuel cell systems and (4) The written notification, fuel cell cartridges containing recording, and reporting of the Section 1320.8(d), Title 5, Code of flammable liquid as cargo on board unintentional release in transportation Federal Regulations, requires PHMSA to aircraft. See 49 CFR 173.230, and of hazardous materials; and provide interested members of the Special Provision 146 of the HMR, and (5) The design, manufacture, public and affected agencies an Packing Instruction 313 of the 2007– fabrication, inspection, marking, opportunity to comment on information 2008 edition of the ICAO Technical maintenance, reconditioning, repair, or collection and recordkeeping requests. Instructions. In addition, the ICAO also testing of a packaging or container This NPRM does not include new adopted (in Section 8:1.1.2(r)) represented, marked, certified, or sold information collection or recordkeeping provisions that will permit these as qualified for use in transporting requirements. devices to be fueled by formic acid or hazardous material. G. Regulation Identifier Number (RIN) butane, and transported in carry-on This proposed rule addresses covered baggage on board passenger-carrying subject items (1), (2), (3), and (5) above A regulation identifier number (RIN) aircraft under certain conditions. This and would preempt State, local, and is assigned to each regulatory action rulemaking proposes to harmonize the Indian tribe requirements not meeting listed in the Unified Agenda of Federal HMR with these additional ICAO the ‘‘substantively the same’’ standard. Regulations. The Regulatory Information requirements. To limit both the safety Pursuant to 49 U.S.C. 5125(b)(2), we Service Center publishes the Unified and environmental consequences would deem federal preemption Agenda in April and October of each should an incident occur, this effective upon the effective date of the year. The RIN contained in the heading rulemaking also proposes restrictions on final rule. We are proposing to make the of this document can be used to cross- the fuel cell system configurations and final rule effective approximately 90 reference this action with the Unified limits on the amount of hazardous days after it is published in the Federal Agenda. material contained in each fuel cell Register. H. Unfunded Mandates Reform Act cartridge. There are no significant D. Executive Order 13175 environmental impacts associated with This proposed rule does not impose this NPRM. This proposed rule was analyzed in unfunded mandates under the accordance with the principles and Unfunded Mandates Reform Act of Alternatives criteria set forth in Executive Order 1995. It does not result in costs of The alternatives PHMSA is 13175 (‘‘Consultation and Coordination $120.7 million or more to either State, considering are as follows: with Indian Tribal Governments’’). local or tribal governments, in the No action—If no action is taken, Because this proposed rule does not aggregate, or to the private sector, and passengers would not be permitted to

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transport personal electronic devices probability and quantity of a hazardous their petitions for rulemaking, powered by fuel cell technology in material release. Hazardous materials numbered P–1475 and P–1483, to carry-on baggage on domestic flights. are categorized by hazard analysis and permit passengers and crew to transport The industry views such authorization experience into hazard classes and in carry-on baggage on board passenger as key to continued development and packing groups. The regulations require aircraft fuel cells containing flammable use of this technology. Without explicit each shipper to classify a material in liquid, formic acid, butane, and Class 8 action to permit airline passengers to accordance with these hazard classes borohydride materials for use in carry fuel cell powered devices, and packing groups; the process of portable electronic devices. PHMSA has technological development could well classifying a hazardous material is itself also received a letter signed by be delayed. This action is not a form of hazard analysis. Further, the approximately 18 companies supporting recommended. regulations require the shipper to the proposed regulation of fuel cells in Actions Proposed in this NPRM—The communicate the material’s hazards the HMR. actions proposed in this NPRM would through use of the hazard class, packing We invite interested persons to harmonize the HMR requirements for group, and proper shipping name on the submit comments on the potential fuel cells with those prescribed in the shipping paper, labels and markings on environmental, safety, and other international regulations. These packages, and placards on transport impacts of the proposals subject to proposed amendments are intended to vehicles. Thus the shipping paper, federal regulation in this NPRM. update, clarify, and provide relief from labels, markings, and placards certain existing regulatory requirements communicate the most significant J. Privacy Act to promote safer transportation findings of the shipper’s hazard Anyone is able to search the practices, finalize outstanding petitions analysis. Excluding compressed gases, electronic form of any written for rulemaking, facilitate international radioactive materials, and explosives, communications and comments commerce, and make the regulations which all have their own packaging received into any of our dockets by the easier to understand. This action is strength criteria, a hazardous material is name of the individual submitting the recommended. assigned to one of three packing groups document (or signing the document, if To Regulate All Fuel Cells in the based upon its degree of hazard—from submitted on behalf of an association, Manner Prescribed in the IEC a high hazard, Packing Group I, to a low business, labor union, etc.). You may Standard—In addition to the materials hazard, Packing Group III material— review DOT’s complete Privacy Act covered by the proposed rule, the IEC except gases and certain other materials Statement in the Federal Register standard covers fuel cells containing with high integrity packagings. The published on April 11, 2000 (Volume solid Division 4.3 (dangerous when wet) HMR are designed to ensure the quality, 65, Number 70; Pages 19477–78), which materials. As explained above, this damage resistance, and performance may also be found at http://dms.dot.gov, design was not included in the ICAO standards of the packaging for each and on and after September 28, 2007, standard to which we are proposing to hazardous material are appropriate for may be found at http:// harmonize in this rulemaking. PHMSA the hazards of the material transported. www.regulations.gov. believes those fuel cell designs that have We have reviewed the risks associated not been included in the ICAO with transporting fuel cell systems and List of Subjects standards warrant further safety review cartridges. The amount of hazardous 49 CFR Part 171 and that adopting a standard material contained within the fuel cells Exports, Hazardous materials inconsistent with the international or cartridges to which this NPRM transportation, Hazardous waste, standard cannot be justified at this time. applies is minimal, limited to 200 mL or Imports, Incorporation by reference, Analysis of Environmental Impacts 200 g by this proposal. Even if a large number of these devices were Reporting and recordkeeping We regulate hazardous materials compromised and their hazardous requirements. transported by aircraft, vessel, rail, and materials contents released, the 49 CFR Part 173 highway. The potential for environmental impact of the release Hazardous materials transportation, environmental damage or contamination would not be significant. We have exists when packages of hazardous Packaging and containers, Radioactive determined there will be no significant materials, Reporting and recordkeeping materials are involved in accidents or en environmental impacts associated with requirements, Uranium. route incidents resulting from cargo this proposed rule. shifts, valve failures, package failures, or 49 CFR Part 175 loading, unloading, or handling Consultation and Public Comment Air carriers, Hazardous materials problems. The ecosystems that could be As discussed above, PHMSA transportation, Incorporation by affected by a release include air, water, consulted with the IEC and many reference, Radioactive materials, soil, and ecological resources (for companies representing the fuel cell Reporting and recordkeeping example, wildlife habitats). The adverse industry here and abroad to prepare for requirements. environmental impacts associated with U.N. Dangerous Goods Council meetings releases of most hazardous materials are on these devices. PHMSA also In consideration of the foregoing, we short-term impacts that can be greatly participated in the technical review of propose to amend 49 CFR Chapter I as reduced or eliminated through prompt papers prepared by these companies follows: clean up of the accident scene. Most explaining the potential risks and PART 171—GENERAL INFORMATION, hazardous materials are not transported measures taken in the IEC standard to REGULATIONS, AND DEFINITIONS in quantities sufficient to cause reduce risks for each fuel the IEC significant, long-term environmental standard states may be present in a fuel 1. The authority citation for part 171 damage if they are released. cell. In addition, also as discussed continues to read as follows: The hazardous material regulatory earlier, PHMSA has consulted Authority: 49 U.S.C. 5101–5128, 44701; 49 system is a risk-management system that extensively with the U.S. Fuel Council, CFR 1.45 and 1.53; Pub. L. 101–410 section is prevention oriented and focused on Medis Technologies, Ltd., and 4 (28 U.S.C. 2461 Note); Pub. L. 104–134 identifying a hazard and reducing the Millenium Cell, Inc., in response to section 31001.

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2. In § 171.7, in paragraph (a)(3), in in appropriate alphabetical order to read § 171.7 Reference material. the Table, an entry for the International as follows: * * * * * Electrotechnical Commission is added (a) * * * (3) * * *

Source and name of material 49 CFR reference

******* International Electrotechnical Commission (IEC) 3, rue de Varembe´, P.O. Box 131, CH—1211, GENEVA 20, Switzerland: Fuel cell technologies—Part 6–1: Micro fuel cell power systems—Safety, IEC/PAS 62282–6–1 First Edition, with Tech- nical Corrigendum 1, 2006 ...... § 175.10

*******

* * * * * PART 175—CARRIAGE BY AIRCRAFT (vii) Interaction between fuel cells 2. In § 171.8, two new definitions for and integrated batteries in a device must 5. The authority citation for part 175 conform to IEC/PAS 62282–6–1. Fuel ‘‘fuel cell’’ and ‘‘fuel cell cartridge’’ are continues to read as follows: added in alphabetical order to read as cell systems for which the sole function follows: Authority: 49 U.S.C. 5101–5128, 44701; 49 is to charge a battery in the device are CFR 1.45, 1.53. not permitted; § 171.8 Definitions and abbreviations. 6. In § 175.10, paragraph (a)(18) is (viii) Fuel cell systems must be of a * * * * * added to read as follows: type that will not charge batteries when the portable electronic device is not in Fuel cell means an electrochemical § 175.10 Exceptions for passengers, crew use; and device that converts the energy of the members, and air operators. (ix) Each fuel cell cartridge and chemical reaction between a fuel, such (a) * * * system that conforms to the as hydrogen or hydrogen rich gases, (18) Portable electronic devices (for requirements in this paragraph (a)(18) alcohols, hydrocarbons, and an oxidant, example, cameras, cellular phones, must be durably marked by the such as air or oxygen, to direct current laptop computers, and camcorders) manufacturer with the wording: (d.c.) power, heat, and other reaction powered by fuel cell systems, and not ‘‘APPROVED FOR CARRIAGE IN products. more than two spare fuel cartridges per AIRCRAFT CABIN ONLY’’ to certify Fuel cell cartridge or Fuel cartridge passenger or crew member, when that the fuel cell cartridge or system means a removable article that contains transported in carry-on baggage by meets the specifications in IEC/PAS and supplies fuel to the micro fuel cell aircraft under the following conditions: 62282–6–1 and with the maximum power unit or internal reservoir, not to (i) Fuel cell cartridges may contain quantity and type of fuel contained in be refilled by the user. only Class 3 flammable liquids the cartridge or system. * * * * * (including methanol), Class 8 formic * * * * * acid, Class 8 borohydride materials, or Division 2.1 butane; Issued in Washington, DC, on September PART 173—SHIPPERS—GENERAL 14, 2007, under the authority delegated in 49 REQUIREMENTS FOR SHIPMENTS (ii) The maximum quantity of fuel in CFR part 106. AND PACKAGINGS any fuel cell cartridge may not exceed: (A) 200 mL (6.76 ounces) for liquids, Theodore L. Willke, (B) 120 mL (4 fluid ounces) for Associate Administrator for Hazardous 3. The authority citation for part 173 Materials Safety. continues to read as follows: liquefied gases in non-metallic fuel cell cartridges, or 200 mL for metal fuel cell [FR Doc. E7–18532 Filed 9–19–07; 8:45 am] Authority: 49 U.S.C. 5101–5128, 44701; 49 cartridges; BILLING CODE 4910–60–P CFR 1.45, 1.53. (C) 200 g (7 ounces) for solids; 4. In § 173.230, paragraph (a) is (iii) No more than two spare fuel cell revised and new paragraph (d) is added, cartridges may be carried by a DEPARTMENT OF THE INTERIOR to read as follows: passenger; (iv) Fuel cell systems containing fuel Fish and Wildlife Service § 173.230 Fuel cell cartridges containing and fuel cell cartridges including spare flammable liquids. cartridges are permitted in carry-on 50 CFR Part 17 (a) A fuel cell cartridge must be baggage only; RIN 1018–AV19 designed and constructed to prevent the (v) Fuel cell cartridges may not be refillable by the user. Refueling of fuel fuel it contains from leaking during Endangered and Threatened Wildlife normal conditions of transportation and cell systems is not permitted except that the installation of a spare cartridge is and Plants; 12-Month Petition Finding be free of electric charge generating and Proposed Rule To List the Polar components. allowed. Fuel cell cartridges that are used to refill fuel cell systems but that Bear (Ursus Maritimus) as Threatened * * * * * are not designed or intended to remain Throughout Its Range (d) Fuel cells intended for installed (fuel cell refills) in a portable AGENCY: Fish and Wildlife Service, transportation in carry-on baggage on electronic device are not permitted; Interior. board passenger aircraft must also (vi) Fuel cell systems and fuel cell ACTION: Reopening of comment period; comply with the applicable provisions cartridges must conform to IEC/PAS notice of availability of new prescribed in § 175.10 of this 62282–6–1 (IBR; see § 171.7 of this information. subchapter. subchapter);

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SUMMARY: We, the U.S. Fish and ‘‘Obtaining Copies of the Nine USGS We are notifying the public of the Wildlife Service (Service), announce the reports’’ section below. availability of these reports and our availability of nine new United States FOR FURTHER INFORMATION CONTACT: Rosa intent to consider them in making our Geological Survey (USGS) reports Meehan, Marine Mammals Management final listing determination. We also are produced for the Service to provide Office (see ADDRESSES) (telephone 907– reopening the comment period for 15 current data and modeling outputs 786–3800). Persons who use a days to provide the public the relevant to the final determination of telecommunications device for the deaf opportunity to provide comments or whether the polar bear (Ursus (TDD) may call the Federal Information information on these reports. We are maritimus) qualifies for listing under Relay Service (FIRS) at 800–877–8339. asking for public comments on these the Endangered Species Act of 1973, as SUPPLEMENTARY INFORMATION: On reports and a review of the extent to amended (Act). We intend to take these January 9, 2007 (72 FR 1064), the which they add to the knowledge base reports into consideration as we make Service published a 12-month petition for making the final decision. our final listing determination on the finding and proposed rule to list the Obtaining Copies of the Nine USGS polar bear. We also are reopening the polar bear (Ursus maritimus) as Reports public comment period on the January threatened throughout its range under You may obtain copies of any of the 9, 2007, proposed rule to list the polar the Act. The document announced a 3- bear as threatened throughout its range nine USGS reports: month public comment period on the • By mail from the U.S. Department under the Act (72 FR 1064). We are proposed rule, which closed on April 9, reopening the comment period for an of the Interior, United States Geological 2007. We also held three public Survey, Office of Communication, 119 additional 15 days to allow interested hearings during the proposed rule’s parties to comment on the nine USGS National Center, Reston, VA 20192; comment period, as announced in the • reports listed below. The comment By calling USGS Public Affairs at February 15, 2007, Federal Register (72 (703) 648–4460; period is being limited to 15 days FR 7381). • because of the statutory deadline, which By visiting the USGS Web site at On September 7, 2007, the Service http://www.usgs.gov/newsroom/special/ requires a final listing determination received nine reports prepared by the _ within one year of publication of the polar bears/; or USGS that provide new data and • Via link to the USGS Web site from proposed rule, unless an extension of up modeling outputs relevant to the final the Service’s Web site: http:// to six months is granted due to determination of whether the polar bear www.fws.gov/. substantial disagreement regarding the qualifies for listing as threatened or Copies of the reports are also available sufficiency or accuracy of the available endangered under the Act. These for public inspection, by appointment data relevant to the determination. reports are: during normal business hours, at the Please note that comments previously (1) Polar Bear Population Status in the U.S. Fish and Wildlife Service, Marine submitted should not be resubmitted. Northern Beaufort Sea by Stirling et al. Mammals Management Office (see This comment period is open only for (2) Polar Bear Population Status in ADDRESSES). comments on the nine USGS reports Southern Hudson Bay Canada by listed below. Comments submitted Obbard et al. Public Comments Solicited during the prior comment period have (3) Polar Bears in the Southern Comments and information submitted been incorporated into the public record Beaufort Sea I: Survival and Breeding in during the initial comment period on and will be fully considered during Relation to Sea Ice Conditions, 2001– the January 9, 2007 (72 FR 1064), preparation of our final determination. 2006 by Regehr et al. proposed rule should not be DATES: We will accept public comments (4) Polar Bears in the Southern resubmitted, as this comment period is until October 5, 2007. Beaufort Sea II: Demography and open only for comments on the nine Population Growth in Relation to Sea USGS reports listed above. Our final ADDRESSES: You may submit comments Ice Conditions by Hunter et al. and materials to us by any one of the determination of whether the polar bear (5) Polar Bears in the Southern following methods: qualifies as threatened or endangered Beaufort Sea III: Stature, Mass, and Cub under the Act will take into (1) You may mail or hand-deliver Recruitment in Relationship to Time consideration all comments and written comments and information to and Sea Ice Extent Between 1982 and information we receive during both the Supervisor, U.S. Fish and Wildlife 2006 by Rode et al. comment periods. Service, Marine Mammals Management (6) Uncertainty in Climate Model You may submit your comments and Office, 1011 East Tudor Road, Predictions of Arctic Sea Ice Decline: any materials concerning the above Anchorage, AK 99503. An Evaluation Relevant to Polar Bears reports by any one of several methods (2) You may send comments by by DeWeaver. (see ADDRESSES). If you use e-mail to electronic mail (e-mail) to: (7) Predicting the Future Distribution submit your comments, please include _ _ Polar Bear [email protected]. For of Polar Bear Habitat in the Polar Basin ‘‘Attn: Polar Bear Finding’’ in your e- instructions on how to file comments from Resource Selection Functions mail subject header, preferably with electronically, see the ‘‘Public Applied to 21st Century General your name and return address in the Comments Solicited’’ section below. In Circulation Model Projections of Sea Ice body of your message. the event that our Internet connection is by Durner et al. Before including your address, phone not functional, please submit your (8) Predicting Movements of Female number, e-mail address, or other comments by one of the alternate Polar Bears between Summer Sea Ice personal identifying information in your methods listed in this section. Foraging Habitats and Terrestrial comments, you should be aware that (3) You may submit your comments Denning Habitats of Alaska in the 21st your entire comment—including your via the Federal eRulemaking Portal at Century: Proposed Methodology and personal identifying information—may http://www.regulations.gov. Follow the Pilot Assessment by Bergen et al. be made publicly available at any time. instructions for submitting comments. (9) Forecasting the Range-wide Status While you can ask us in your comment For information on obtaining copies of Polar Bears at Selected Times in the to withhold from public view your of the nine USGS reports, see the 21st Century by Amstrup et al. personal identifying information, we

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cannot guarantee that we will be able to • E-mail: In response, the Councils, working do so. [email protected]. Include in closely with NMFS, undertook the subject line the following identifier: Author development of a remedy that would ‘‘Comments on the Proposed Rule to address all Northeast Region FMPs. The The primary author of this notice is implement the SBRM Omnibus Councils took final action to adopt the staff of the U.S. Fish and Wildlife Amendment.’’ SBRM Amendment at their meetings in • Service. Federal e-rulemaking portal: http:/ June 2007, and submitted the Authority: The authority for this action is www.regulations.gov. amendment for review shortly • Mail: Patricia A. Kurkul, Regional the Endangered Species Act of 1973, as thereafter. This amendment covers 13 Administrator, NMFS, Northeast amended (16 U.S.C. 1531 et seq.). FMPs, 39 managed species, and 14 types Regional Office, One Blackburn Drive, Dated: September 13, 2007. of fishing gear. The purpose of the Gloucester, MA 01930. Mark the outside H. Dale Hall, of the envelope: ‘‘Comments on the amendment is to: Explain the methods Director, U.S. Fish and Wildlife Service. Proposed Rule to implement the SBRM and processes by which bycatch is [FR Doc. 07–4652 Filed 9–17–07; 11:03 am] Omnibus Amendment.’’ currently monitored and assessed for BILLING CODE 4310–55–P • Fax: (978) 281–9135 Northeast Region fisheries; determine Copies of the SBRM Amendment, and whether these methods and processes of the draft Environmental Assessment need to be modified and/or DEPARTMENT OF COMMERCE and preliminary Regulatory Impact supplemented; establish standards of Review (EA/RIR), are available from precision for bycatch estimation for all National Oceanic and Atmospheric Daniel T. Furlong, Executive Director, Northeast Region fisheries; and, thereby, Administration Mid-Atlantic Fishery Management document the SBRM established for all Council, Room 2115, Federal Building, fisheries managed through the FMPs of 50 CFR Part 648 300 South New Street, Dover, DE the Northeast Region. The amendment [Docket No. 070627217–7218–01] 19901–6790; and from Paul J. Howard, also responds to the ‘‘potentially Executive Director, New England important scientific evidence’’ cited by RIN 0648–AV70 Fishery Management Council, 50 Water the Court in the two decisions Street, Newburyport, MA 01950. The Magnuson-Stevens Fishery referenced above. EA/RIR is also accessible via the Conservation and Management Act Internet at http://www.nero.noaa.gov. On July 26, 3007 (72 FR 41047), Provisions; Fisheries of the NMFS published a notice of availability FOR FURTHER INFORMATION CONTACT: Northeastern United States; Northeast that requested comments on the SBRM Region Standardized Bycatch Michael Pentony, Senior Fishery Policy Analyst, 978–281–9283. Amendment and draft Environmental Reporting Methodology Omnibus Assessment. The comment period on SUPPLEMENTARY INFORMATION: Amendment the notice of availability closes on AGENCY: National Marine Fisheries Background September 24, 2007. On August 21, Service (NMFS), National Oceanic and Section 303(a)(11) of the Magnuson- 2007 (72 FR 46588), NMFS published a Atmospheric Administration (NOAA), Stevens Act requires that all FMPs proposed rule that requested comments Commerce. ‘‘establish a standardized reporting on the regulations to implement the ACTION: Proposed rule; extension of methodology to assess the amount and SBRM Amendment. The comment comment period. type of bycatch occurring in the period on the proposed rule was fishery.’’ In 2004, several conservation scheduled to close on September 20, SUMMARY: NMFS extends for 4 days the organizations challenged the approval of 2007. In order to provide the maximum comment period on the proposed rule to two major amendments to Northeast opportunity for the public to review and implement the Standardized Bycatch Region FMPs. In ruling on these suits, provide comments on the proposed rule Reporting Methodology (SBRM) the U.S. District Court for the District of to implement the SBRM Amendment, Omnibus Amendment (SBRM Columbia found that the FMPs did not NMFS is extending the comment period Amendment) to the Fishery clearly establish an SBRM as required on the proposed rule to 5 p.m. on Management Plans (FMPs) of the under the relevant section of the September 24, 2007. With this Northeast Region, developed by the Magnuson-Stevens Act and remanded extension, both comment periods will Mid-Atlantic and New England Fishery the amendments back to the agency to end at the same time. Management Councils (Councils). fully develop and establish the required Dated: September 17, 2007. DATES: The deadline for written SBRM. In particular, the Court found comments on the August 21, 2007 (72 that the amendments (1) failed to fully Samuel D. Rauch III, FR 46588), proposed rule is extended evaluate reporting methodologies to Deputy Assistant Administrator For from September 20, 2007, to no later assess bycatch, (2) did not mandate an Regulatory Programs, National Marine than 5 p.m. on September 24, 2007. SBRM, and (3) failed to respond to Fisheries Service. ADDRESSES: You may submit comments potentially important scientific [FR Doc. E7–18590 Filed 9–19–07; 8:45 am] by any of the following methods: evidence. BILLING CODE 3510–22–S

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Notices Federal Register Vol. 72, No. 182

Thursday, September 20, 2007

This section of the FEDERAL REGISTER ‘‘Search for Open Regulations’’ box, specified in the regulations relating to contains documents other than rules or select ‘‘Food Safety and Inspection the application for inspection, proposed rules that are applicable to the Service’’ from the agency drop-down accreditation of laboratories, and public. Notices of hearings and investigations, menu, then click on ‘‘Submit.’’ In the exemptions. committee meetings, agency decisions and Docket ID column, select FDMS Docket FSIS requires meat and poultry rulings, delegations of authority, filing of petitions and applications and agency Number FSIS–2007–0028 to submit or establishments and import facilities to statements of organization and functions are view public comments and to view apply for a grant of inspection before examples of documents appearing in this supporting and related materials they can receive Federal inspection (9 section. available electronically. CFR 304.1 & 381.17). FSIS also requires All submissions received by mail or plants that wish to receive voluntary electronic mail must include the Agency inspection to apply for inspection (9 DEPARTMENT OF AGRICULTURE name and docket number. All comments CFR 350.5, 351.4, 352.3, & 362.3). submitted in response to this document, Establishments that wish to export or Food Safety and Inspection Service as well as research and background import product must also submit certain [Docket No. FSIS–2007–0028] information used by FSIS in developing documents to the Agency. this document, will be available for The FMIA (21 U.S.C. 642), the PPIA Notice of Request for a Revision of a public inspection in the FSIS Docket (21 U.S.C. 460(b)), and the EPIA (21 Currently Approved Information Room at the address listed above U.S.C. 1040) require certain parties to Collection (Application for Inspection, between 8:30 a.m. and 4:30 p.m., keep records that fully and correctly Accreditation of Laboratories, and Monday through Friday, except Federal disclose all transactions involved in Exemptions) holidays. Comments will also be posted their businesses related to relevant on the Agency’s Web site at http:// animal carcasses and parts and egg AGENCY: Food Safety and Inspection www.fsis.usda.gov/ products. Service, USDA. regulations_&_policies/ FSIS requires accredited non-Federal ACTION: Notice and request for regulations_directives_&_notices/ analytical laboratories to maintain comments. index.asp. Individuals who do not wish certain paperwork and records (9 CFR 319.10 & 590.580). The Agency uses this SUMMARY: In accordance with the FSIS to post their personal contact collected information to ensure that Paperwork Reduction Act of 1995 and information—mailing address, e-mail meat and poultry establishments and the Office of Management and Budget address, and telephone number—on the egg products plants provide safe, (OMB) regulations, the Food Safety and Internet may leave the information off wholesome, and unadulterated product, Inspection Service (FSIS) is announcing their comments. and that non-Federal laboratories act in its intention to request a revision of an FOR FURTHER INFORMATION CONTACT: accordance with FSIS regulations. approved information collection Contact John O’Connell, Paperwork In addition, FSIS also collects concerning the regulatory requirements Reduction Act Coordinator, Food Safety information to ensure that meat and for application for inspection, and Inspection Service, USDA, 1400 poultry establishments exempted from accreditation of laboratories, and Independence Avenue, SW., Room 3532 Agency inspection do not commingle exemptions because of revised estimates South Building, Washington, DC 20250, inspected and non-inspected meat and that support a finding of fewer total (202) 720–0345. poultry products (9 CFR 303.1(b)(3) & burden hours. SUPPLEMENTARY INFORMATION: 381.10(a)(1)), and that firms qualifying DATES: Comments on this notice must be Title: Application for Inspection, Accreditation of Laboratories, and for a retail store exemption who have received on or before November 19, violated the provision of that exemption 2007. Exemptions. OMB Number: 0583–0082. are no longer in violation (9 CFR ADDRESSES: FSIS invites interested Expiration Date of Approval: 12/31/ 303.1(d)(3) & 381.10(d)(3)). persons to submit comments on this 2007. The Agency is revising the notice. Comments may be submitted by Type of Request: Revision of an information collection based on a any of the following methods: approved information collection. revised estimate of the number of • Mail, including floppy disks or CD- Abstract: FSIS has been delegated the respondents, which support a finding of ROMs, and hand- or courier-delivered authority to exercise the functions of the fewer total burden hours (113,048) than items: Send to Docket Clerk, U.S. Secretary as specified in the Federal there are in the approved information Department of Agriculture, Food Safety Meat Inspection Act (FMIA) (21 U.S.C. collection (114,583). and Inspection Service, 1400 601, et seq.), the Poultry Products FSIS has made the following Independence Avenue, SW., Room 2534 Inspection Act (PPIA) (21 U.S.C. 451, et estimates based upon an information South Building, Washington, DC 20250. seq.), and the Egg Products Inspection collection assessment: • Electronic mail: Act (EPIA) (21 U.S.C. 1031, et seq.). Estimate of Burden: FSIS estimates [email protected]. FSIS protects the public by verifying that it will take respondents an average • Federal eRulemaking Portal: This that meat, poultry, and egg products are of .034 hours per response. Web site provides the ability to type safe, wholesome, unadulterated, and Respondents: Official meat and short comments directly into the properly labeled and packaged. poultry establishments, official egg comment field on this Web page or FSIS is requesting a revision of an plants, and foreign establishments. attach a file for lengthier comments. Go approved information collection Estimated No. of Respondents: to http://www.regulation.gov and in the addressing paperwork requirements 24,622.

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Estimated No. of Annual Responses FSIS is able to provide information to a SUPPLEMENTARY INFORMATION: per Respondent: 136. much broader, more diverse audience. Estimated Total Annual Burden on In addition, FSIS offers an e-mail I. Abstract Respondents: 113,048 hours. subscription service which provides This collection of information is Copies of this information collection automatic and customized access to required by the Trademark Act, 15 assessment can be obtained from John selected food safety news and U.S.C. Section 1051, et seq., which O’Connell, Paperwork Reduction Act information. This service is available at provides for the Federal registration of Coordinator, Food Safety and Inspection http://www.fsis.usda.gov/ trademarks, service marks, collective Service, USDA, 300 12th Street, SW., news_and_events/email_subscription/. trademarks and service marks, collective Room 112, Washington, DC 20250, Options range from recalls to export membership marks, and certification (202)720–0345. information to regulations, directives marks. Individuals and businesses that Comments are invited on: (a) Whether and notices. Customers can add or use or intend to use such marks in the proposed collection of information delete subscriptions themselves, and commerce may file an application to is necessary for the proper performance have the option to password protect register their marks with the United of FSIS’ functions, including whether their accounts. States Patent and Trademark Office the information will have practical (USPTO). In some cases, the USPTO utility; (b) the accuracy of FSIS’ estimate Done at Washington, DC, on: September 17, 2007. may issue an Office Action to an of the burden of the proposed collection Alfred V. Almanza, applicant in order to request additional of information, including the validity of information that is required before a the methodology and assumptions used; Administrator. [FR Doc. E7–18574 Filed 9–19–07; 8:45 am] mark can be registered. The USPTO may (c) ways to enhance the quality, utility, also issue an Office Action to advise an BILLING CODE 3410–DM–P and clarity of the information to be applicant that a mark cannot be collected; and (d) ways to minimize the registered due to one or more provisions burden of the collection of information of the Trademark Act. Applicants may PATENT AND TRADEMARK OFFICE on establishments, including through reply to these Office Actions by the use of appropriate automated, providing the required information or electronic, mechanical, or other Electronic Response to Office Action and Preliminary Amendment Forms by putting forth legal arguments as to technological collection techniques, or why the refusal of registration should be other forms of information technology. ACTION: Proposed collection; comment withdrawn. Comments may also be sent to the Desk request. Applicants may also supplement their Officer for Agriculture, Office of applications by providing additional Information and Regulatory Affairs, SUMMARY: The United States Patent and information voluntarily. When such Office of Management and Budget, Trademark Office (USPTO), as part of its information is provided before the Washington, DC 20253. continuing effort to reduce paperwork All responses to this notice will be USPTO has reviewed the application, and respondent burden, invites the the applicant may submit the additional summarized and included in the request general public and other Federal for OMB approval. All comments will information in the form of a Preliminary agencies to comment on the continuing Amendment. also become a matter of public record. information collection, as required by The forms in this collection are the Paperwork Reduction Act of 1995, Additional Public Notification available in electronic format through Public Law 104–13 (44 U.S.C. the Trademark Electronic Application Public awareness of all segments of 3506(c)(2)(A)). rulemaking and policy development is System (TEAS), which may be accessed important. Consequently, in an effort to DATES: Written comments must be on the USPTO Web site. The USPTO is ensure that the public and in particular submitted on or before November 19, proposing to add two forms to this minorities, women, and persons with 2007. information collection, Post Publication disabilities, are aware of this notice, ADDRESSES: You may submit comments Amendment (PTO–1711) and Response FSIS will announce it on-line through by any of the following methods: to Suspension Inquiry or Letter of the FSIS Web page located at http:// • E-mail: [email protected]. Suspension (PTO–1822). Applicants www.fsis.usda.gov/regulations/ Include ‘‘0651–0050 comment’’ in the may file a Post Publication Amendment 2007_Notices_Index/index.asp. subject line of the message. in order to submit a proposed FSIS also will make copies of this • Fax: 571–273–0112, marked to the amendment to an application that has Federal Register publication available attention of Susan Fawcett. already been approved for publication through the FSIS Constituent Update, • Mail: Susan K. Fawcett, Records by the examining attorney. If an which is used to provide information Officer, Office of the Chief Information applicant receives a Suspension Inquiry regarding FSIS policies, procedures, Officer, Customer Information Services or Letter of Suspension from the regulations, Federal Register notices, Group, Public Information Services USPTO, the applicant may use the FSIS public meetings, and other types of Division, United States Patent and proposed response form to file a reply. information that could affect or would Trademark Office, P.O. Box 1450, Applicants may submit the two be of interest to our constituents and Alexandria, VA 22313–1450. proposed new forms to the USPTO stakeholders. The Update is FOR FURTHER INFORMATION CONTACT: electronically through TEAS or submit communicated via Listserv, a free e-mail Requests for additional information the required information for the subscription service consisting of should be directed to Sharon Marsh, amendment or response to the USPTO industry, trade, and farm groups, Deputy Commissioner for Trademark on paper. The USPTO does not provide consumer interest groups, allied health Examination Policy, Office of the official forms for these paper professionals, scientific professionals, Commissioner for Trademarks, United submissions. and other individuals who have States Patent and Trademark Office, II. Method of Collection requested to be included. The Update P.O. Box 1451, Alexandria, VA 22313– also is available on the FSIS Web page. 1451, by telephone at 571–272–8900, or By mail, facsimile, hand delivery, or Through Listserv and the Web page, by e-mail at [email protected]. electronic transmission.

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III. Data Suspension Inquiry or Letter of Response to Suspension Inquiry or Suspension. Letter of Suspension. OMB Number: 0651–0050. Estimated Total Annual Respondent Form Number(s): PTO–1771, PTO– Estimated Time per Response: The USPTO estimates that the public will Cost Burden: $8,280,960. The USPTO 1882, PTO–1930, PTO–1957 and PTO– expects that the information in this 1966. require approximately 10 to 18 minutes (0.17 to 0.30 hours) to supply the collection will primarily be prepared by Type of Review: Revision of a attorneys, though some submissions information requested in this collection. currently approved collection. may be prepared by pro se applicants. Completion times may vary, depending Affected Public: Individuals or Using the professional hourly rate of upon the nature and amount of households; businesses or other for- $304 for associate attorneys in private profits; and not-for-profit institutions. information requested in a particular firms, the USPTO estimates that the Estimated Number of Respondents: Office Action. respondent cost burden for submitting 158,300 responses per year, including Estimated Total Annual Respondent the information in this collection will be 1,800 responses per year for Post Burden Hours: 27,240 hours, including approximately $8,280,960 per year, Publication Amendments and 5,600 495 hours for Post Publication including $482,448 for the proposed responses per year for the Response to Amendments and 1,092 hours for the forms.

Estimated time Estimated Estimated Item for response annual annual (minutes) responses burden hours

Post Publication Amendment (TEAS) ...... 15 900 225 Post Publication Amendment (paper) ...... 18 900 270 Response to Suspension Inquiry or Letter of Suspension (TEAS) ...... 10 2,800 476 Response to Suspension Inquiry or Letter of Suspension (paper) ...... 13 2,800 616

Total ...... 7,400 1,587

Estimated Total Annual Non-hour they also will become a matter of public COMMODITY FUTURES TRADING Respondent Cost Burden: $1,517. There record. COMMISSION are no capital start-up costs, Dated: September 12, 2007. maintenance costs, or filing fees Sunshine Act Meetings associated with this information Susan K. Fawcett, collection. However, customers may Records Officer, USPTO, Office of the Chief TIME AND DATE: 11 a.m., Friday, October incur postage costs when submitting a Information Officer, Customer Information 5, 2007. Post Publication Amendment or Services Group, Public Information Services Response to Suspension Inquiry or Division. PLACE: 1155 21st St., NW., Washington, Letter of Suspension to the USPTO by [FR Doc. E7–18567 Filed 9–19–07; 8:45 am] DC, 9th Floor Commission Conference mail. The USPTO estimates that it may BILLING CODE 3510–16–P Room. receive up to 3,700 mailed submissions STATUS: Closed. per year for these items with an estimated postage cost of 41 cents per MATTERS TO BE CONSIDERED: Surveillance response. Therefore, this collection has COMMODITY FUTURES TRADING Matters. COMMISSION an annual (non-hour) cost of CONTACT PERSON FOR MORE INFORMATION: approximately $1,517 per year in the Sauntia S. Warfield, 202–418–5084. form of postage costs. Sunshine Act Meetings David A. Stawick, IV. Request for Comments TIME AND DATE: 2 p.m., Thursday, Secretary of the Commission. Comments are invited on: (a) Whether October 4, 2007. [FR Doc. 07–4685 Filed 9–18–07; 10:45 am] the proposed collection of information PLACE: 1155 21st St., NW., Washington, BILLING CODE 6351–01–M is necessary for the proper performance DC, 9th Floor Commission Conference of the functions of the agency, including Room. whether the information shall have COMMODITY FUTURES TRADING practical utility; (b) the accuracy of the STATUS: Closed. COMMISSION agency’s estimate of the burden MATTERS TO BE CONSIDERED: Rule (including hours and cost) of the Enforcement Review. Sunshine Act Meetings proposed collection of information; (c) ways to enhance the quality, utility, and CONTACT PERSON FOR MORE INFORMATION: TIME AND DATE: 11 a.m., Friday, October clarity of the information to be Sauntia S. Warfield, 202–418–5084. 12, 2007. collected; and (d) ways to minimize the burden of the collection of information David A. Stawick, PLACE: 1155 21st St., NW., Washington, on respondents, e.g., the use of Secretary of the Commission. DC, 9th Floor Commission Conference automated collection techniques or [FR Doc. 07–4684 Filed 9–18–07; 10:45 am] Room. other forms of information technology. BILLING CODE 6351–01–M STATUS: Closed. Comments submitted in response to this notice will be summarized or MATTERS TO BE CONSIDERED: Surveillance included in the request for OMB Matters. approval of this information collection;

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CONTACT PERSON FOR MORE INFORMATION: Sunshine in the Government Act of organizations wishing to submit written Sauntia S. Warfield, 202–418–5084. 1976 (5 U.S.C. 552b, as amended) and comments for consideration by the Task 41 Code of Federal Regulations (CFR) Force should provide their comments in David A. Stawick, §§ 102–3.140 through 160, the an electronic (PDF Format) document Secretary of the Commission. Department of Defense announces the through the Task Force Web site [FR Doc. 07–4686 Filed 9–18–07; 10:45 am] following committee meeting: (http://www.DoDfuturehealthcare.net) at BILLING CODE 6351–01–M Name of Committee: Department of the ‘‘Contact Us’’ page, no later than five Defense Task Force on the Future of (5) business days prior to the scheduled Military Health Care, a duly established meeting. COMMODITY FUTURES TRADING subcommittee of the Defense Health Dated: September 17, 2007. COMMISSION Board. L. M. Bynum, Date of Meeting: October 3, 2007. Sunshine Act Meetings Time of Meeting: 9 a.m. to 3 p.m. Alternate OSD Federal Register Liaison Place of Meeting: National Officer, Department of Defense. TIME AND DATE: 11 a.m. Friday, October Transportation Safety Board Conference [FR Doc. 07–4689 Filed 9–18–07; 11:18 am] 19, 2007. Center, 429 L’Enfant Plaza, Washington, BILLING CODE 5001–06–M PLACE: 1155 21st St., NW., Washington, DC 20594. DC, 9th Floor Commission Conference Purpose of Meeting: To obtain, Room. review, and evaluate information related ELECTION ASSISTANCE COMMISSION STATUS: Closed. to the Task Force’s congressionally- MATTERS TO BE CONSIDERED: Surveillance directed mission to examine matters Sunshine Act Notice Matters. relating to the future of military health AGENCY: care. The Task Force members will United States Election CONTACT PERSON FOR MORE INFORMATION: Assistance Commission. Sauntia S. Warfield, 202–418–5084. receive briefings on topics related to the delivery of military health care during ACTION: Notice of public meeting. David A. Stawick, the public meeting. DATE AND TIME: Thursday, October 4, Secretary of the Commission. Agenda: Discussion topics will 2007, 10 a.m.–1 p.m. [FR Doc. 07–4687 Filed 9–18–07; 10:45 am] include: Military and Civilian Personnel PLACE: U.S. Election Assistance BILLING CODE 6351–01–M Mix; Managing Health Care Needs of Commission, 1225 New York Ave., NW., Medicare-Eligible Beneficiaries. Suite 150, Washington, DC 20005 Prior to the public meeting the Task (Metro Stop: Metro Center). COMMODITY FUTURES TRADING Force will conduct a Preparatory Work AGENDA: Commissioners will receive the COMMISSION Meeting from 8 a.m.–8:50 a.m. to solely following presentations: Perspectives analyze relevant issues and facts in Sunshine Act Meetings from state officials on how EAC can use preparation for the Task Force’s next its regulatory authority under the public meeting. In addition, the task National Voter Registration Act (NVRA) TIME AND DATE: 11 a.m. Friday, October Force, following its public meeting, will 26, 2007. to address changes in voter registration conduct an addditional Preparatory procedures; Commissioners will receive PLACE: 1155 21st St., NW., Washington, Work Meeting from 3:10 p.m. to 4:10 updates on the next iteration of the DC, 9th Floor Commission Conference p.m. to analyze relevant issues and facts Voluntary Voting System Guidelines Room. in preparation for the Task Force’s next (VVSG) and a report on a STATUS: Closed. public meeting. Both Preparatory recommendation from the National MATTERS TO BE CONSIDERED: Surveillance Meetings will be held at the National Voluntary Laboratory Accreditation Matters. Transportation Safety Board Conference Program (NVLAP); Commissioners will Center, and pursuant to 41 Code of CONTACT PERSON FOR MORE INFORMATION: discuss other administrative matters. Federal Regulations, Part 102–3.160(a), Sauntia S. Warfield, 202–418–5084. This meeting will be open to the both Preparatory Work Meetings are public. David A. Stawick, closed to the public. PERSON TO CONTACT FOR INFORMATION: Secretary of the Commission. Additional information and meeting registration is available online at the Bryan Whitener, Telephone: (202) 566– [FR Doc. 07–4688 Filed 9–18–07; 10:45 am] 3100. BILLING CODE 6351–01–M Task Force Web site: http:// www.DoDfuturehealthcare.net Thomas R. Wilkey, FOR FURTHER INFORMATION CONTACT: Executive Director, U.S. Election Assistance DEPARTMENT OF DEFENSE Colonel Christine Bader, Executive Commission. Secretary, Department of Defense Task [FR Doc. 07–4701 Filed 9–18–07; 2:46 pm] Office of the Secretary Force on the Future of Military Health BILLING CODE 6820–KF–M Care, TMA/Code: DHS, Five Skyline Department of Defense Task Force on Place, Suite 810, 5111 Leesburg Pike, the Future of Military Health Care; Falls Church, Virginia 22041–3206, DEPARTMENT OF ENERGY Sunshine Act Meeting (703) 681–3279, ext. 109 ([email protected]). Notice of Interim Approval AGENCY: Department of Defense, Office of the Assistant Secretary of Defense SUPPLEMENTARY INFORMATION: Open AGENCY: Southeastern Power (Health Affairs); DoD. sessions of the meeting will be limited Administration, DOE. ACTION: Notice of meeting. by space accommodations. Any ACTION: Notice of Rate Order. interested person may attend; however, SUMMARY: Pursuant to the Federl seating is limited to the space available SUMMARY: The Deputy Secretary of Advisory Committee Act of 1972 (5 at the National Transportation Safety Energy confirmed and approved, on an U.S.C., Appendix, as amended), the Board Conference Center. Individuals or interim basis, Rate Schedules SOCO–1–

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C, SOCO–2–C, SOCO–3–C, SOCO–4–C, Delegation Order No. 0204–108, Response 1: Estimates of future Corps ALA–1–L, MISS–1–L, Duke–1–C, Duke– effective May 30, 1986, 51 FR 19744 Operations & Maintenance (O&M) 2–C, Duke–3–C, Duke–4–C, Santee–1–C, (May 30, 1986), the Secretary of Energy Expense were provided by the Corps of Santee–2–C, Santee–3–C, Santee–4–C, delegated to Southeastern’s Engineers to the O&M Committee of the SCE&G–1–C, SCE&G–2–C, SCE&G–3–C, Administrator the authority to develop SeFPC in April of 2006. Southeastern SCE&G–4–C, Replacement–1, Pump–1– power and transmission rates, delegated believes that these are the best estimates A, Pump–2, and Regulation–1. The new to the Under Secretary of Energy the available. Southeastern shares the rates take effect on October 1, 2007, and authority to confirm, approve, and place customer’s concerns with the rate of were approved on an interim basis in effect such rates on an interim basis, increase of Corps O&M expense and through September 30, 2012. The new and delegated to the Federal Energy will, in conjunction with the O&M rates are subject to confirmation and Regulatory Commission (FERC) the Committee of the SeFPC, monitor and approval on a final basis by the Federal authority to confirm, approve and place review this expense. Energy Regulatory Commission. into effect on a final basis or to Comment 2: The high level for 2006 DATES: Approval of the rate schedule on disapprove rates developed by the may be attributable to large increases in an interim basis is effective October 1, Administrator under the delegation. On spending at the Carters and Russell 2007 through September 30, 2012. December 6, 2001, the Secretary of projects that will not be repeated in FOR FURTHER INFORMATION CONTACT: Energy issued Delegation Order No. 00– future years. Leon Jourolmon, Assistant 037.00, granting the Deputy Secretary of Response 2: Information provided by Administrator, Finance & Marketing, Energy authority to confirm, approve, the Corps of Engineers suggests costs at Southeastern Power Administration, and place into effect Southeastern’s the Carters and Russell projects may Department of Energy, 1166 Athens rates on an interim basis. This rate order have been higher in Fiscal Year 2006 Tech Road, Elberton, Georgia 30635– is issued by the Deputy Secretary due to some nonrecurring work. 6711, (706)–213–3800. pursuant to said notice. Nevertheless, Southeastern believes SUPPLEMENTARY INFORMATION: The Background these estimates are the best available for the purposes of this rate filing. Federal Energy Regulatory Commission, Power from the Georgia-Alabama- by Order issued November 3, 2004, in Southeastern will, in conjunction with South Carolina System is presently sold the O&M Committee of the SeFPC, Docket No. EF03–3011–000, confirmed under Wholesale Power Rate Schedules and approved Wholesale Power Rate monitor and review O&M Expense for SOCO–1–B, SOCO–2–B, SOCO–3–B, the Georgia-Alabama-South Carolina Schedules SOCO–1–B, SOCO–2–B, SOCO–4–B, ALA–1–K, MISS–1–K, SOCO–3–B, SOCO–4–B, ALA–1–K, System Projects. Duke–1–B, Duke–2–B, Duke–3–B, MISS–1–K, Duke–1–B, Duke–2–B, Comment 3: The SeFPC [asks] SEPA Duke–4–B, Santee–1–B, Santee–2–B, Duke–3–B, Duke–4–B, Santee–1–B, to review the proposed increase for Santee–3–B, Santee–4–B, SCE&G–1–B, Santee–2–B, Santee–3–B, Santee–4–B, O&M and recent {events} at the Carters SCE&G–2–B, SCE&G–3–B, SCE&G–4–B, SCE&G–1–B, SCE&G–2–B, SCE&G–3–B, and Russell project to determine if any Regulation–1, Replacement–1, Pump–1– SCE&G–4–B, Regulation–1, of these O&M expenses should be A, and Pump–2. These rate schedules Replacement–1, Pump–1–A, and Pump– capitalized. If costs have been included were approved by the FERC on 2. Rate schedules SOCO–1–C, SOCO–2– as O&M expenses which should more November 3, 2004, for a period ending C, SOCO–3–C, SOCO–4–C, ALA–1–L, properly be capitalized, the SeFPC September 30, 2007 (109 FERC ¶ MISS–1–L, Duke–1–C, Duke–2–C, would request that SEPA make the Duke–3–C, Duke–4–C, Santee–1–C, 61,133). appropriate reductions in O&M Santee–2–C, Santee-3–C, Santee–4–C, Public Notice and Comment expenses and commensurate increases in the capital project expenditures. SCE&G–1–C, SCE&G–2–C, SCE&G–3–C, Notice of proposed rate adjustment Response 3: The Corps of Engineers SCE&G–4–C, Replacement–1, Pump–1– was published in the Federal Register prepares its financial statements in A, Pump–2 and Regulation–1 replace April 4, 2007 (72 FR 16345). The notice accordance with Corps Directives. these schedules. advised interested parties of a proposed Southeastern has reviewed the Corps’ Dated: September 11, 2007. rate increase of about eight and one-half cost reporting and has not discovered Clay Sell, percent (8.5%). A public information any material items that the Corps and comment forum was scheduled for Deputy Secretary of Energy. expensed and Southeastern believes May 10, 2007. Subsequent to the public should be capitalized. Southeastern will Department of Energy information and comment forum, the work with the Corps to ensure proposed rates were revised. With the Deputy Secretary appropriate reporting of all revisions, the proposed rate adjustment In the Matter of: Southeastern Power expenditures. is an increase of about seven percent Administration B Georgia-Alabama- (7%). Written comments were accepted Discussion South Carolina Rates; Rate Order No. on or before July 3, 2007. Written SEPA–48; Order Confirming and System Repayment comments were received from one Approving Power Rates on an Interim source, the Southeastern Federal Power An examination of Southeastern’s Basis Customers (SeFPC), pursuant to this revised system power repayment study, Pursuant to Sections 302(a) and notice. prepared in July, 2007, for the Georgia- 301(b) of the Department of Energy The following comments were Alabama-South Carolina System, shows Organization Act, Public Law 95–91, the received during the comment period. that with the proposed rates, all system functions of the Secretary of the Interior Southeastern’s response follows each power costs are paid within the 50-year and the Federal Power Commission comment. repayment period required by existing under Section 5 of the Flood Control Comment 1: Customers are concerned law and DOE Order RA 6120.2. The Act of 1944, 16 U.S.C. 825s, relating to with a 28% increase in O&M expense Administrator of Southeastern has the Southeastern Power Administration from the previous study, which is certified that the rates are consistent (Southeastern) were transferred to and largely responsible for the overall with applicable law and that they are vested in the Secretary of Energy. By increase in the rates. the lowest possible rates to customers

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consistent with sound business transmitted and scheduled pursuant to (FERC) involving Southern Companies’ principles. contracts between the Government and Open Access Transmission Tariff Southern Company Services, (OATT). The distribution charges may Environmental Impact Incorporated (hereinafter called the be modified by FERC pursuant to Southeastern has reviewed the Company) and the Customer. Nothing in application by the Company under possible environmental impacts of the this rate schedule shall preclude Section 205 of the Federal Power Act or rate adjustment under consideration and modifications to the aforementioned the Government under Section 206 of has concluded that, because the contracts to allow an eligible customer the Federal Power Act. adjusted rates would not significantly to elect service under another rate Proceedings before FERC involving affect the quality of the human schedule. the OATT or the Distribution charge environment within the meaning of the Applicability: This rate schedule shall may result in the separation of charges National Environmental Policy Act of be applicable to the sale at wholesale of currently included in the transmission 1969, the proposed action is not a major power and accompanying energy rate. In this event, the Government may Federal action for which preparation of generated at the Allatoona, Buford, J. charge the Customer for any and all an Environmental Impact Statement is Strom Thurmond, Walter F. George, separate transmission and distribution required. (10 CFR Part 1021, Subpart D, Hartwell, Millers Ferry, West Point, charges paid by the Government in App. B4.3) Robert F. Henry, Carters and Richard B. behalf of the Customer. Availability of Information Russell Projects and sold under Scheduling, System Control and appropriate contracts between the Dispatch Service: $0.0806 per kilowatt Information regarding these rates, Government and the Customer. This rate of total contract demand per month. including studies, and other supporting schedule does not apply to energy from Reactive Supply and Voltage Control materials is available for public review pumping operations at the Carters and from Generation Sources Service: $0.11 in the offices of Southeastern Power Richard B. Russell Projects. per kilowatt of total contract demand Administration, 1166 Athens Tech Character of Service: The electric per month. Road, Elberton, Georgia 30635–6711. capacity and energy supplied hereunder Regulation and Frequency Response Submission to the Federal Energy will be delivered at the delivery points Service: $0.0483 per kilowatt of total Regulatory Commission of the Customer on the Company’s contract demand per month. transmission and distribution system. The rates hereinafter confirmed and Transmission, System Control, Reactive, Monthly Rate: The monthly rate for approved on an interim basis, together and Regulation Services capacity, energy, and generation with supporting documents, will be services provided under this rate The charges for Transmission, System submitted promptly to FERC for schedule for the period specified shall Control, Reactive, and Regulation confirmation and approval on a final be: Services shall be governed by and basis, ending no later than September Capacity Charge: $3.70 per kilowatt of subject to refund based upon the 30, 2012. total contract demand per month. determination in the proceeding Order Energy Charge: 9.32 mills per involving Southern Companies’ Open Access Transmission Tariff. In view of the foregoing and pursuant kilowatt-hour. Generation Services: $0.12 per Contract Demand: The contract to the authority delegated to me by the kilowatt of total contract demand per demand is the amount of capacity in Secretary of Energy, I hereby confirm month. kilowatts stated in the contract which and approve on an interim basis, Additional rates for Transmission, the Government is obligated to supply effective October 1, 2007, attached System Control, Reactive, and and the Customer is entitled to receive. Wholesale Power Rate Schedules Regulation Services provided under this Energy To Be Furnished by the SOCO–1–C, SOCO–2–C, SOCO–3–C, rate schedule shall be the rates charged Government: The Government will sell SOCO–4–C, ALA–1–L, MISS–1–L, Southeastern Power Administration by to the Customer and the Customer will Duke–1–C, Duke–2–C, Duke–3–C, the Company. Future adjustments to purchase from the Government energy Duke–4–C, Santee–1–C, Santee–2–C, these rates will become effective upon each billing month equivalent to a Santee–3–C, Santee–4–C, SCE&G–1–C, acceptance for filing by the Federal percentage specified by contract of the SCE&G–2–C, SCE&G–3–C, SCE&G–4–C, Energy Regulatory Commission of the energy made available to the company Replacement–1, Pump–1–A, Pump–2 Company’s rate. (less applicable losses). The Customer’s and Regulation–1. The rate schedules Transmission: $2.17 per kilowatt of contract demand and accompanying shall remain in effect on an interim total contract demand per month as of energy will be allocated proportionately basis through September 30, 2012, February 2007 is presented for to its individual delivery points served unless such period is extended or until illustrative purposes. from the Company’s system. As of July FERC confirms and approves them or The initial transmission charge will 2007, applicable energy losses are as substitute rate schedules on a final be the Customer’s ratable share of the follows: basis. Transmission and Distribution Charges Transmission facilities: 2.2% Dated: September 11, 2007. paid by the Government. The initial Sub-transmission: 2.0% Clay Sell, monthly transmission demand charge Distribution Substations: 0.9% Deputy Secretary of Energy. shall be determined by multiplying the Distribution Lines: 2.25% Government’s Load Ratio Share times These losses shall be effective until Wholesale Power Rate Schedule SOCO– 1 one twelfth ( ⁄12) of Southern modified by the Federal Energy 1–C Companies’ Annual Transmission Costs Regulatory Commission, pursuant to Availability: This rate schedule shall as specified in Schedule 1 of the application by Southern Companies be available to public bodies and Government-Company Contract. The under Section 205 of the Federal Power cooperatives (any one of whom is transmission charges are governed by Act or SEPA under Section 206 of the hereinafter called the Customer) in and subject to refund based upon the Federal Power Act or otherwise. Georgia, Alabama, Mississippi, and determination in proceedings before the Billing Month: The billing month for Florida to whom power may be Federal Energy Regulatory Commission power sold under this schedule shall

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end at 12 midnight on the last day of Transmission and Distribution Charges Regulatory Commission, pursuant to each calendar month. paid by the Government. The initial application by Southern Companies monthly transmission demand charge under Section 205 of the Federal Power Wholesale Power Rate Schedule SOCO– shall be determined by multiplying the Act or SEPA under Section 206 of the 2–C Government’s Load Ratio Share times Federal Power Act or otherwise. Availability: This rate schedule shall one twelfth (1⁄12) of Southern Billing Month: The billing month for be available to public bodies and Companies’ Annual Transmission Costs power sold under this schedule shall cooperatives (any one of whom is as specified in Schedule 1 of the end at 12 midnight on the last day of hereinafter called the Customer) in Government-Company Contract. The each calendar month. Georgia, Alabama, Mississippi, and transmission charges are governed by Florida to whom power may be and subject to refund based upon the Wholesale Power Rate Schedule transmitted pursuant to contracts determination in proceedings before the SOCO–3–C between the Government and Southern Federal Energy Regulatory Commission Availability: This rate schedule shall Company Services, Incorporated (FERC) involving Southern Companies’ be available to public bodies and (hereinafter called the Company) and Open Access Transmission Tariff cooperatives (any one of whom is the Customer. The Customer is (OATT). The distribution charges may hereinafter called the Customer) in responsible for providing a scheduling be modified by FERC pursuant to Georgia, Alabama, Mississippi, and arrangement with the Government. application by the Company under Florida to whom power may be Nothing in this rate schedule shall Section 205 of the Federal Power Act or scheduled pursuant to contracts preclude modifications to the the Government under Section 206 of between the Government and Southern aforementioned contracts to allow an the Federal Power Act. Company Services, Incorporated eligible customer to elect service under Proceedings before FERC involving (hereinafter called the Company) and another rate schedule. the OATT or the Distribution charge the Customer. The Customer is Applicability: This rate schedule shall may result in the separation of charges responsible for providing a transmission be applicable to the sale at wholesale of currently included in the transmission arrangement. Nothing in this rate power and accompanying energy rate. In this event, the Government may schedule shall preclude modifications generated at the Allatoona, Buford, J. charge the Customer for any and all to the aforementioned contracts to allow Strom Thurmond, Walter F. George, separate transmission and distribution an eligible customer to elect service Hartwell, Millers Ferry, West Point, charges paid by the Government in under another rate schedule. Robert F. Henry, Carters and Richard B. behalf of the Customer. Applicability: This rate schedule shall Reactive Supply and Voltage Control Russell Projects and sold under be applicable to the sale at wholesale of from Generation Sources Service: $0.11 appropriate contracts between the power and accompanying energy per kilowatt of total contract demand Government and the Customer. This rate generated at the Allatoona, Buford, J. per month. schedule does not apply to energy from Strom Thurmond, Walter F. George, pumping operations at the Carters and Transmission, System Control, Reactive, Hartwell, Millers Ferry, West Point, Richard B. Russell Projects. and Regulation Services Robert F. Henry, Carters and Richard B. Character of Service: The electric The charges for Transmission, System Russell Projects (hereinafter referred to capacity and energy supplied hereunder collectively as the Projects) and sold will be delivered at the delivery points Control, Reactive, and Regulation Services shall be governed by and under appropriate contracts between the of the Customer on the Company’s Government and the Customer. This rate transmission and distribution system. subject to refund based upon the determination in the proceeding schedule does not apply to energy from Monthly Rate: The monthly rate for pumping operations at the Carters and capacity, energy, and generation involving Southern Companies’ Open Access Transmission Tariff. Richard B. Russell Projects. services provided under this rate Character of Service: The electric schedule for the period specified shall Contract Demand: The contract demand is the amount of capacity in capacity and energy supplied hereunder be: will be delivered at the Projects. Capacity Charge: $3.70 per kilowatt of kilowatts stated in the contract which Monthly Rate: The monthly rate for total contract demand per month. the Government is obligated to supply Energy Charge: 9.32 mills per and the Customer is entitled to receive. capacity, energy, and generation kilowatt-hour. Energy To Be Furnished by the services provided under this rate Generation Services: $0.12 per Government: The Government will sell schedule for the period specified shall kilowatt of total contract demand per to the Customer and the Customer will be: month. purchase from the Government energy Capacity Charge: $3.70 per kilowatt of Additional rates for Transmission, each billing month equivalent to a total contract demand per month. System Control, Reactive, and percentage specified by contract of the Energy Charge: 9.32 mills per Regulation Services provided under this energy made available to the company kilowatt-hour. rate schedule shall be the rates charged (less applicable losses). The Customer’s Generation Services: $0.12 per Southeastern Power Administration by contract demand and accompanying kilowatt of total contract demand per the Company. Future adjustments to energy will be allocated proportionately month. these rates will become effective upon to its individual delivery points served Additional rates for Transmission, acceptance for filing by the Federal from the Company’s system. As of July System Control, Reactive, and Energy Regulatory Commission of the 2007, applicable energy losses are as Regulation Services provided under this Company’s rate. follows: rate schedule shall be the rates charged Transmission: $2.17 per kilowatt of Transmission facilities: 2.2% Southeastern Power Administration by total contract demand per month as of Sub-Transmission: 2.0% the Company. Future adjustments to February is presented for illustrative Distribution Substations: 0.9% these rates will become effective upon purposes. Distribution Lines: 2.25% acceptance for filing by the Federal The initial transmission charge will These losses shall be effective until Energy Regulatory Commission of the be the Customer’s ratable share of the modified by the Federal Energy Company’s rate.

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Scheduling, System Control and Character of Service: The electric from pumping operations at the Carters Dispatch Service: $0.0806 per kilowatt capacity and energy supplied hereunder and Richard B. Russell Projects. of total contract demand per month. will be delivered at the Projects. Character of Service: The electric Regulation and Frequency Response Monthly Rate: The monthly rate for capacity and energy supplied hereunder Service: $0.0483 per kilowatt of total capacity, energy, and generation will be three-phase alternating current contract demand per month. services provided under this rate at a nominal frequency of 60 Hertz and schedule for the period specified shall shall be delivered at the Walter F. Transmission, System Control, Reactive, be: George, West Point, and Robert F. Henry and Regulation Services Capacity Charge: $3.70 per kilowatt of Projects. The charges for Transmission, System total contract demand per month. Monthly Rate: The monthly rate for Control, Reactive, and Regulation Energy Charge: 9.32 mills per capacity, energy, and generation Services shall be governed by and kilowatt-hour. services provided under this rate subject to refund based upon the Generation Services: $0.12 per schedule for the period specified shall determination in the proceeding kilowatt of total contract demand per be: involving Southern Companies’ Open month. Capacity Charge: $3.70 per kilowatt of Access Transmission Tariff. Additional rates for Transmission, total contract demand per month. Contract Demand: The contract System Control, Reactive, and Energy Charge: 9.32 mills per demand is the amount of capacity in Regulation Services provided under this kilowatt-hour. kilowatts stated in the contract which rate schedule shall be the rates charged Generation Services: $0.12 per the Government is obligated to supply Southeastern Power Administration by kilowatt of total contract demand per and the Customer is entitled to receive. the Company. Future adjustments to month. Additional rates for Transmission, Energy To Be Furnished by the these rates will become effective upon System Control, Reactive, and Government: The Government will sell acceptance for filing by the Federal Regulation Services provided under this to the Customer and the Customer will Energy Regulatory Commission of the rate schedule shall be the rates charged purchase from the Government energy Company’s rate. Southeastern Power Administration by each billing month equivalent to a Transmission, System Control, Reactive, the Southern Company. Future percentage specified by contract of the and Regulation Services adjustments to these rates will become energy made available to the company The charges for Transmission, System effective upon acceptance for filing by (less applicable losses). Control, Reactive, and Regulation the Federal Energy Regulatory Billing Month: The billing month for Services shall be governed by and Commission of the Company’s rate. power sold under this schedule shall subject to refund based upon the end at 12 midnight on the last day of determination in the proceeding Transmission, System Control, Reactive, each calendar month. involving Southern Companies’ Open and Regulation Services Wholesale Power Rate Schedule Access Transmission Tariff. The charges for Transmission, System SOCO–4–C Contract Demand: The contract Control, Reactive, and Regulation demand is the amount of capacity in Services shall be governed by and Availability: This rate schedule shall kilowatts stated in the contract which subject to refund based upon the be available to public bodies and the Government is obligated to supply determination in the proceeding cooperatives (any one of whom is and the Customer is entitled to receive. involving Southern Companies’ Open hereinafter called the Customer) in Energy To Be Furnished by the Access Transmission Tariff. Georgia, Alabama, Mississippi, and Government: The Government will sell Energy To Be Furnished by the Florida served through the transmission to the Customer and the Customer will Government: The Government will sell facilities of Southern Company Services, purchase from the Government energy to the Cooperative and the Cooperative Inc. (hereinafter called the Company) or each billing month equivalent to a will purchase from the Government the Georgia Integrated Transmission percentage specified by contract of the those quantities of energy specified by System. The Customer is responsible for energy made available to the company contract as available to the Cooperative providing a scheduling arrangement (less applicable losses). for scheduling on a weekly basis. with the Government and for providing Billing Month: The billing month for Billing Month: The billing month for a transmission arrangement. Nothing in power sold under this schedule shall power sold under this schedule shall this rate schedule shall preclude end at 12 midnight on the last day of end at 12 midnight on the last day of modifications to the aforementioned each calendar month. each calendar month. contracts to allow an eligible customer to elect service under another rate Wholesale Power Rate Schedule ALA– Wholesale Power Rate Schedule MISS– schedule. 1–L 1–L Applicability: This rate schedule shall Availability: This rate schedule shall Availability: This rate schedule shall be applicable to the sale at wholesale of be available to the Alabama Electric be available to the South Mississippi power and accompanying energy Cooperative, Incorporated (hereinafter Electric Power Association (hereinafter generated at the Allatoona, Buford, J. called the Cooperative). called the Customer) to whom power Strom Thurmond, Walter F. George, Applicability: This rate schedule shall may be wheeled pursuant to contracts Hartwell, Millers Ferry, West Point, be applicable to power and between the Government and Alabama Robert F. Henry, Carters and Richard B. accompanying energy generated at the Electric Cooperative, Inc. (hereinafter Russell Projects (hereinafter referred to Allatoona, Buford, J. Strom Thurmond, called AEC). collectively as the Projects) and sold Walter F. George, Hartwell, Millers Applicability: This rate schedule shall under appropriate contracts between the Ferry, West Point, Robert F. Henry, be applicable to the sale at wholesale of Government and the Customer. This rate Carters, and Richard B. Russell Projects power and accompanying energy schedule does not apply to energy from and sold under contract between the generated at the Allatoona, Buford, J. pumping operations at the Carters and Cooperative and the Government. This Strom Thurmond, Walter F. George, Richard B. Russell Projects. rate schedule does not apply to energy Hartwell, Millers Ferry, West Point,

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Robert F. Henry, Carters and Richard B. contract as available to the Cooperative Transmission Distribution Charges paid Russell Projects and sold under for scheduling on a weekly basis. by the Government. The initial monthly appropriate contracts between the Billing Month: The billing month for transmission demand charge shall Government and the Customer. This rate power sold under this schedule shall reflect the Government’s Load Ratio schedule does not apply to energy from end at 12 midnight on the last day of Share Responsibility. The Load Ratio pumping operations at the Carters and each calendar month. Share shall be computed each month and shall be the ratio of the Network Richard B. Russell Projects. Wholesale Power Rate Schedule Duke– Load to the average of the Company’s Character of Service: The electric 1–C capacity and energy supplied hereunder Transmission System load for each of will be three-phase alternating current Availability: the 12 preceding months. The at a nominal frequency of 60 Hertz This rate schedule shall be available Company’s Transmission System Load delivered at the delivery points of the to public bodies and cooperatives (any shall be the load as determined in Customer on AEC’s transmission and one of whom is hereinafter called the Section 34.3 of the Company’s Pro distribution system. The voltage of Customer) in North Carolina and South Forma Open Access Transmission Tariff delivery will be maintained within the Carolina to whom power may be (the Tariff). The Government shall pay limits established by the state regulatory transmitted and scheduled pursuant to a monthly demand charge which shall commission. contracts between the Government and be determined by multiplying its Load Monthly Rate: The monthly rate for Duke Power Company (hereinafter Ratio Share by 1⁄12 of the Annual capacity, energy, and generation called the Company) and the Customer. Transmission Revenue Requirement set services provided under this rate Nothing in this rate schedule shall forth in Attachment H of the Company’s schedule for the period specified shall preclude modifications to the Tariff. be: aforementioned contracts to allow an Proceedings before FERC involving Capacity Charge: $3.70 per kilowatt of eligible customer to elect service under the Tariff may result in the separation total contract demand per month. another rate schedule. of charges currently included in the Applicability: This rate schedule shall Energy Charge: 9.32 mills per transmission rate. In this event, the be applicable to the sale at wholesale of kilowatt-hour. Government may charge the Customer power and accompanying energy for any and all separate transmission Generation Services: $0.12 per generated at the Allatoona, Buford, J. and distribution charges paid by the kilowatt of total contract demand per Strom Thurmond, Walter F. George, Government in behalf of the Customer. month. Hartwell, Millers Ferry, West Point, Contract Demand: The contract Additional rates for Transmission, Robert F. Henry, Carters and Richard B. demand is the amount of capacity in System Control, Reactive, and Russell Projects and sold under kilowatts stated in the contract which Regulation Services provided under this appropriate contracts between the the Government is obligated to supply rate schedule shall be the rates charged Government and the Customer. This rate and the Customer is entitled to receive. Southeastern Power Administration by schedule does not apply to energy from Energy To Be Furnished by the the Company. Future adjustments to pumping operations at the Carters and Government: The Government will sell these rates will become effective upon Richard B. Russell Projects. to the Customer and the Customer will acceptance for filing by the Federal Character of Service: The electric purchase from the Government energy Energy Regulatory Commission of the capacity and energy supplied hereunder each billing month equivalent to a Company’s rate. will be delivered at the delivery points percentage specified by contract of the Transmission: $2.25 per kilowatt of of the Customer on the Company’s energy made available to the company total contract demand per month as of transmission and distribution system. (less applicable losses of three per cent February 2007 is presented for Monthly Rate: The monthly rate for (3%) as of February 2007). The illustrative purposes. capacity, energy, and generation Customer’s contract demand and This rate is subject to annual services provided under this rate accompanying energy will be allocated adjustment on January 1, and will be schedule for the period specified shall proportionately to its individual computed subject to the Appendix A be: delivery points served from the attached to the Government–AEC Capacity Charge: $3.70 per kilowatt of Company’s system. These losses shall be contract. total contract demand per month. effective until modified by the Federal Transmission, System Control, Reactive, Energy Charge: 9.32 mills per Energy Regulatory Commission, and Regulation Services kilowatt-hour. pursuant to application by the Company Generation Services: $0.12 per under Section 205 of the Federal Power The charges for Transmission, System kilowatt of total contract demand per Act or SEPA under Section 206 of the Control, Reactive, and Regulation month. Federal Power Act or otherwise. Services shall be governed by and Additional rates for Transmission, Billing Month: The billing month for subject to refund based upon the System Control, Reactive, and power sold under this schedule shall determination in the proceeding Regulation Services provided under this end at 12 midnight on the last day of involving Southern Companies’ Open rate schedule shall be the rates charged each calendar month. Access Transmission Tariff. Southeastern Power Administration by Contract Demand: The contract the Company. Future adjustments to Wholesale Power Rate Schedule Duke– demand is the amount of capacity in these rates will become effective upon 2–C kilowatts stated in the contract that the acceptance for filing by the Federal Availability: This rate schedule shall Government is obligated to supply and Energy Regulatory Commission of the be available to public bodies and the Customer is entitled to receive. Company’s rate. cooperatives (any one of whom is Energy To Be Furnished by the Transmission: $0.87 per kilowatt of hereinafter called the Customer) in Government: The Government will sell total contract demand per month is North Carolina and South Carolina to to the Cooperative and the Cooperative presented for illustrative purposes. whom power may be transmitted will purchase from the Government The initial transmission charge will pursuant to contracts between the those quantities of energy specified by be the Customer’s ratable share of the Government and Duke Power Company

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(hereinafter called the Company) and a monthly demand charge which shall Russell Projects and sold under the Customer. The Customer is be determined by multiplying its Load appropriate contracts between the responsible for providing a scheduling Ratio Share by 1⁄12 of the Annual Government and the Customer. This rate arrangement with the Government. Transmission Revenue Requirement set schedule does not apply to energy from Nothing in this rate schedule shall forth in Attachment H of the Company’s pumping operations at the Carters and preclude modifications to the Tariff. Richard B. Russell Projects. aforementioned contracts to allow an Proceedings before FERC involving Character of Service: The electric eligible customer to elect service under the Tariff may result in the separation capacity and energy supplied hereunder another rate schedule. of charges currently included in the will be delivered at the Savannah River Applicability: This rate schedule shall transmission rate. In this event, the Projects. be applicable to the sale at wholesale of Government may charge the Customer Monthly Rate: The monthly rate for power and accompanying energy for any and all separate transmission capacity, energy, and generation generated at the Allatoona, Buford, J. and distribution charges paid by the services provided under this rate Strom Thurmond, Walter F. George, Government in behalf of the Customer. schedule for the period specified shall Hartwell, Millers Ferry, West Point, Contract Demand: The contract be: Robert F. Henry, Carters and Richard B. demand is the amount of capacity in Capacity Charge: $3.70 per kilowatt of Russell Projects and sold under kilowatts stated in the contract which total contract demand per month. appropriate contracts between the the Government is obligated to supply Energy Charge: 9.32 mills per Government and the Customer. This rate and the Customer is entitled to receive. kilowatt-hour. schedule does not apply to energy from Energy To Be Furnished by the Government: The Government will sell Generation Services: $0.12 per pumping operations at the Carters and kilowatt of total contract demand per Richard B. Russell Projects. to the Customer and the Customer will purchase from the Government energy month. Character of Service: The electric Additional rates for Transmission, capacity and energy supplied hereunder each billing month equivalent to a percentage specified by contract of the System Control, Reactive, and will be delivered at the delivery points Regulation Services provided under this of the Customer on the Company’s energy made available to the company (less applicable losses of three per cent rate schedule shall be the rates charged transmission and distribution system. Southeastern Power Administration by Monthly Rate: The monthly rate for (3%) as of February 2007). The the Company. Future adjustments to capacity, energy, and generation Customer’s contract demand and these rates will become effective upon services provided under this rate accompanying energy will be allocated acceptance for filing by the Federal schedule for the period specified shall proportionately to its individual Energy Regulatory Commission of the be: delivery points served from the Capacity Charge: $3.70 per kilowatt of Company’s system. These losses shall be Company’s rate. total contract demand per month. effective until modified by the Federal Contract Demand: The contract Energy Charge: 9.32 mills per Energy Regulatory Commission, demand is the amount of capacity in kilowatt-hour. pursuant to application by the Company kilowatts stated in the contract which Generation Services: $0.12 per under Section 205 of the Federal Power the Government is obligated to supply kilowatt of total contract demand per Act or SEPA under Section 206 of the and the Customer is entitled to receive. month. Federal Power Act or otherwise. Energy To Be Furnished by the Additional rates for Transmission, Billing Month: The billing month for Government: The Government will sell System Control, Reactive, and power sold under this schedule shall to the Customer and the Customer will Regulation Services provided under this end at 12 midnight on the last day of purchase from the Government energy rate schedule shall be the rates charged each calendar month. each billing month equivalent to a Southeastern Power Administration by percentage specified by contract of the the Company. Future adjustments to Wholesale Power Rate Schedule energy made available to the company these rates will become effective upon Duke–3–C (less applicable losses). acceptance for filing by the Federal Availability: This rate schedule shall Billing Month: The billing month for Energy Regulatory Commission of the be available to public bodies and power sold under this schedule shall Company’s rate. cooperatives (any one of whom is end at 12 midnight on the last day of Transmission: $0.87 per kilowatt of hereinafter called the Customer) in each calendar month. total contract demand per month is North Carolina and South Carolina to Wholesale Power Rate Schedule presented for illustrative purposes. whom power may be scheduled Duke–4–C The initial transmission charge will pursuant to contracts between the be the Customer’s ratable share of the Government and Duke Power Company Availability: This rate schedule shall Transmission Distribution Charges paid (hereinafter called the Company) and be available to public bodies and by the Government. The initial monthly the Customer. The Customer is cooperatives (any one of whom is transmission demand charge shall responsible for providing a transmission hereinafter called the Customer) in reflect the Government’s Load Ratio arrangement. Nothing in this rate North Carolina and South Carolina Share Responsibility. The Load Ratio schedule shall preclude modifications served through the transmission Share shall be computed each month to the aforementioned contracts to allow facilities of Duke Power Company and shall be the ratio of the Network an eligible customer to elect service (hereinafter called the Company) and Load to the average of the Company’s under another rate schedule. the Customer. The Customer is Transmission System load for each of Applicability: This rate schedule shall responsible for providing a scheduling the 12 preceding months. The be applicable to the sale at wholesale of arrangement with the Government and Company’s Transmission System Load power and accompanying energy for providing a transmission shall be the load as determined in generated at the Allatoona, Buford, J. arrangement with the Company. Section 34.3 of the Company’s Pro Strom Thurmond, Walter F. George, Nothing in this rate schedule shall Forma Open Access Transmission Tariff Hartwell, Millers Ferry, West Point, preclude modifications to the (the Tariff). The Government shall pay Robert F. Henry, Carters and Richard B. aforementioned contracts to allow an

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eligible customer to elect service under end at 12 midnight on the last day of Energy Regulatory Commission of the another rate schedule. each calendar month. Authority’s rate. Applicability: This rate schedule shall Wholesale Power Rate Schedule Transmission: $1.06 per kilowatt of be applicable to the sale at wholesale of Santee–1–C total contract demand per month as of power and accompanying energy February 2007 is presented for generated at the Allatoona, Buford, J. Availability: This rate schedule shall illustrative purposes. Strom Thurmond, Walter F. George, be available to public bodies and The initial transmission rate is subject Hartwell, Millers Ferry, West Point, cooperatives (any one of whom is to annual adjustment on July 1 of each Robert F. Henry, Carters and Richard B. hereinafter call the Customer) in South year, and will be computed subject to Russell Projects and sold under Carolina to whom power may be the formula contained in Appendix A to appropriate contracts between the wheeled and scheduled pursuant to the Government-Authority Contract. Government and the Customer. This rate contracts between the Government and Proceedings before the Federal Energy schedule does not apply to energy from South Carolina Public Service Authority Regulatory Commission involving the pumping operations at the Carters and (hereinafter called the Authority). Authority’s Open Access Transmission Richard B. Russell Projects. Nothing in this rate schedule shall Tariff may result in the separation of Character of Service: The electric preclude an eligible customer from charges currently included in the capacity and energy supplied hereunder electing service under another rate transmission rate. In this event, the will be delivered at the Savannah River schedule. Government may charge the Customer Projects. Applicability: This rate schedule shall for any and all separate transmission Monthly Rate: The monthly rate for be applicable to the sale at wholesale of and distribution charges paid by the capacity, energy, and generation power and accompanying energy Government in behalf of the Customer. services provided under this rate generated at the Allatoona, Buford, J. Contract Demand: The contract schedule for the period specified shall Strom Thurmond, Walter F. George, demand is the amount of capacity in be: Hartwell, Millers Ferry, West Point, kilowatts stated in the contract which Capacity Charge: $3.70 per kilowatt of Robert F. Henry, Carters and Richard B. the Government is obligated to supply total contract demand per month. Russell Projects and sold under and the Customer is entitled to receive. Energy Charge: 9.32 mills per appropriate contracts between the kilowatt-hour. Government and the Customer. This rate Energy To Be Furnished by the Generation Services: $0.12 per schedule does not apply to energy from Government: The Government will sell kilowatt of total contract demand per pumping operations at the Carters and to the Customer and the Customer will month. Richard B. Russell Projects. purchase from the Government energy Additional rates for Transmission, Character of Service: The electric each billing month equivalent to a System Control, Reactive, and capacity and energy supplied hereunder percentage specified by contract of the Regulation Services provided under this will be delivered at the delivery points energy made available to the Authority rate schedule shall be the rates charged of the Customer on the Authority’s (less applicable losses of two per cent Southeastern Power Administration by transmission and distribution system. (2%) as of February 2007). The the Company. Future adjustments to Monthly Rate: The monthly rate for Customer’s contract demand and these rates will become effective upon capacity, energy, and generation accompanying energy will be allocated acceptance for filing by the Federal services provided under this rate proportionately to its individual Energy Regulatory Commission of the schedule for the period specified shall delivery points served from the Company’s rate. be: Authority’s system. Contract Demand: The contract Capacity Charge: $3.70 per kilowatt of Billing Month: The billing month for demand is the amount of capacity in total contract demand per month. power sold under this schedule shall kilowatts stated in the contract which Energy Charge: 9.32 mills per end at 12 midnight on the last day of the Government is obligated to supply kilowatt-hour. each calendar month. and the Customer is entitled to receive. Generation Services: $0.12 per Service Interruption: When energy Energy To Be Furnished by the kilowatt of total contract demand per delivery to the Customer’s system for Government: The Government will sell month. the account of the Government is to the Customer and the Customer will Additional rates for Transmission, reduced or interrupted, and such purchase from the Government energy System Control, Reactive, and reduction or interruption is not due to each billing month equivalent to a Regulation Services provided under this conditions on the Customer’s system, percentage specified by contract of the rate schedule shall be the rates charged the demand charge for the month shall energy made available to the company Southeastern Power Administration by be appropriately reduced as to kilowatts (less applicable losses). the Authority. Future adjustments to of such capacity which have been Billing Month: The billing month for these rates will become effective upon interrupted or reduced for each day in power sold under this schedule shall acceptance for filing by the Federal accordance with the following formula:

 Number of kilowatts unavailable     × Monthly Capacity Charge  for at least 12 hours in     any calendar day   Number of Dayys in Billing Month 

Wholesale Power Rate Schedule cooperatives (any one of whom is Public Service Authority (hereinafter Santee–2–C hereinafter call the Customer) in South called the Authority). The customer is Carolina to whom power may be responsible for providing a scheduling Availability: This rate schedule shall wheeled pursuant to contracts between arrangement with the Government. be available to public bodies and the Government and South Carolina Nothing in this rate schedule shall

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preclude an eligible customer from Additional rates for Transmission, Government is obligated to supply and electing service under another rate System Control, Reactive, and the Customer is entitled to receive. schedule. Regulation Services provided under this Energy To Be Furnished by the Applicability: This rate schedule shall rate schedule shall be the rates charged Government: The Government will sell be applicable to the sale at wholesale of Southeastern Power Administration by to the Customer and the Customer will power and accompanying energy the Authority. Future adjustments to purchase from the Government energy generated at the Allatoona, Buford, J. these rates will become effective upon Strom Thurmond, Walter F. George, each billing month equivalent to a acceptance for filing by the Federal percentage specified by contract of the Hartwell, Millers Ferry, West Point, Energy Regulatory Commission of the energy made available to the Authority Robert F. Henry, Carters and Richard B. Authority’s rate. Russell Projects and sold under (less applicable losses of two percent Transmission: $1.06 per kilowatt of (2%) as of February 2007). The appropriate contracts between the total contract demand per month as of Government and the Customer. This rate Customer’s contract demand and February 2007 is presented for accompanying energy will be allocated schedule does not apply to energy from illustrative purposes. pumping operations at the Carters and proportionately to its individual The initial transmission rate is subject delivery points served from the Richard B. Russell Projects. to annual adjustment on July 1 of each Character of Service: The electric Authority’s system. year, and will be computed subject to capacity and energy supplied hereunder the formula contained in Appendix A to Billing Month: The billing month for will be delivered at the delivery points the Government-Authority Contract. power sold under this schedule shall of the Customer on the Authority’s Proceedings before the Federal Energy end at 12 midnight on the last day of transmission and distribution system. each calendar month. Monthly Rate: The monthly rate for Regulatory Commission involving the capacity, energy, and generation Authority’s Open Access Transmission Service Interruption: When energy services provided under this rate Tariff may result in the separation of delivery to the Customer’s system for schedule for the period specified shall charges currently included in the the account of the Government is be: transmission rate. In this event, the reduced or interrupted, and such Capacity Charge: $3.70 per kilowatt of Government may charge the Customer reduction or interruption is not due to total contract demand per month. for any and all separate transmission conditions on the Customer’s system, Energy Charge: 9.32 mills per and distribution charges paid by the the demand charge for the month shall kilowatt-hour. Government in behalf of the Customer. be appropriately reduced as to kilowatts Generation Services: $0.12 per Contract Demand: The contract of such capacity which have been kilowatt of total contract demand per demand is the amount of capacity in interrupted or reduced for each day in month. kilowatts stated in the contract that the accordance with the following formula:

 Number of kilowatts unavailable     × Monthly Capacity Charge  for at least 12 hours in     any calendar day   Number of Dayys in Billing Month 

Wholesale Power Rate Schedule pumping operations at the Carters and Contract Demand: The contract Santee–3–C Richard B. Russell Projects. demand is the amount of capacity in Character of Service: The electric kilowatts stated in the contract that the Availability: This rate schedule shall capacity and energy supplied hereunder Government is obligated to supply and be available to public bodies and will be delivered at the Projects. the Customer is entitled to receive. cooperatives (any one of whom is Monthly Rate: The monthly rate for Energy To Be Furnished by the hereinafter called the Customer) in Government: The Government will sell South Carolina to whom power may be capacity, energy, and generation services provided under this rate to the Customer and the Customer will scheduled pursuant to contracts purchase from the Government energy between the Government and South schedule for the period specified shall be: each billing month equivalent to a Carolina Public Service Authority percentage specified by contract of the Capacity Charge: $3.70 per kilowatt of (hereinafter called the Authority). The energy made available to the Authority total contract demand per month. customer is responsible for providing a (less applicable losses). transmission arrangement. Nothing in Energy Charge: 9.32 mills per Billing Month: The billing month for this rate schedule shall preclude an kilowatt-hour. power sold under this schedule shall eligible customer from electing service Generation Services: $0.12 per end at 12 midnight on the last day of under another rate schedule. kilowatt of total contract demand per each calendar month. Applicability: This rate schedule shall month. Service Interruption: When energy be applicable to the sale at wholesale of Additional rates for Transmission, delivery to the Customer’s system for power and accompanying energy System Control, Reactive, and the account of the Government is generated at the Allatoona, Buford, J. Regulation Services provided under this reduced or interrupted, and such Strom Thurmond, Walter F. George, rate schedule shall be the rates charged reduction or interruption is not due to Hartwell, Millers Ferry, West Point, Southeastern Power Administration by conditions on the Customer’s system, Robert F. Henry, Carters and Richard B. the Authority. Future adjustments to the demand charge for the month shall Russell Projects and sold under these rates will become effective upon be appropriately reduced as to kilowatts appropriate contracts between the acceptance for filing by the Federal of such capacity which have been Government and the Customer. This rate Energy Regulatory Commission of the interrupted or reduced for each day in schedule does not apply to energy from Authority’s rate. accordance with the following formula:

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 Number of kilowatts unavailable     × Monthly Capacity Charge  for at least 12 hours in     any calendar day   Number of Dayys in Billing Month 

Wholesale Power Rate Schedule pumping operations at the Carters and Contract Demand: The contract Santee–4–C Richard B. Russell Projects. demand is the amount of capacity in Availability: This rate schedule shall Character of Service: The electric kilowatts stated in the contract that the be available to public bodies and capacity and energy supplied hereunder Government is obligated to supply and cooperatives (any one of whom is will be delivered at the Projects. the Customer is entitled to receive. hereinafter call the Customer) in South Monthly Rate: The monthly rate for Energy To Be Furnished by the Carolina served through the capacity, energy, and generation Government: The Government will sell transmission facilities of South Carolina services provided under this rate to the Customer and the Customer will Public Service Authority (hereinafter schedule for the period specified shall purchase from the Government energy called the Authority). The customer is be: each billing month equivalent to a percentage specified by contract of the responsible for providing a scheduling Capacity Charge: $3.70 per kilowatt of energy made available to the Authority arrangement with the Government and total contract demand per month. for providing a transmission (less applicable losses). Energy Charge: 9.32 mills per arrangement. Nothing in this rate Billing Month: The billing month for kilowatt-hour. schedule shall preclude an eligible power sold under this schedule shall customer from electing service under Generation Services: $0.12 per end at 12 midnight on the last day of another rate schedule. kilowatt of total contract demand per each calendar month. Applicability: This rate schedule shall month. Service Interruption: When energy be applicable to the sale at wholesale of Additional rates for Transmission, delivery to the Customer’s system for power and accompanying energy System Control, Reactive, and the account of the Government is generated at the Allatoona, Buford, J. Regulation Services provided under this reduced or interrupted, and such Strom Thurmond, Walter F. George, rate schedule shall be the rates charged reduction or interruption is not due to Hartwell, Millers Ferry, West Point, Southeastern Power Administration by conditions on the Customer’s system, Robert F. Henry, Carters and Richard B. the Authority. Future adjustments to the demand charge for the month shall Russell Projects and sold under these rates will become effective upon be appropriately reduced as to kilowatts appropriate contracts between the acceptance for filing by the Federal of such capacity which have been Government and the Customer. This rate Energy Regulatory Commission of the interrupted or reduced for each day in schedule does not apply to energy from Authority’s rate. accordance with the following formula:

 Number of kilowatts unavailable     × Monthly Capacity Charge  for at least 12 hours in     any calendar day   Number of Dayys in Billing Month 

Wholesale Power Rate Schedule pumping operations at the Carters and Energy Regulatory Commission of the SCE&G–1–C Richard B. Russell Projects. Company’s rate. Character of Service: The electric Transmission: $0.85 per kilowatt of Availability: This rate schedule shall capacity and energy supplied hereunder total contract demand per month is be available public bodies and will be delivered at the delivery points presented for illustrative purposes. cooperatives (any one of which is of the Customer on the Company’s The initial rate will be subject to hereinafter called the Customer) in transmission and distribution system. monthly adjustment and will be South Carolina to whom power may be Monthly Rate: The monthly rate for computed subject to Section 7 of the wheeled and scheduled pursuant to capacity, energy, and generation Government-Company contract. contracts between the Government and services provided under this rate Proceedings before the Federal Energy the South Carolina Electric & Gas schedule for the period specified shall Regulatory Commission involving the Company (hereinafter called the be: Company’s Open Access Transmission Company). Nothing in this rate schedule Capacity Charge: $3.70 per kilowatt of Tariff may result in the separation of shall preclude an eligible customer from total contract demand per month. charges currently included in the electing service under another rate Energy Charge: 9.32 mills per transmission rate. In this event, the schedule. kilowatt-hour. Government may charge the Customer Applicability: This rate schedule shall Generation Services: $0.12 per for any and all separate transmission be applicable to the sale at wholesale of kilowatt of total contract demand per and distribution charges paid by the power and accompanying energy month. Government in behalf of the Customer. generated at the Allatoona, Buford, J. Additional rates for Transmission, Contract Demand: The contract Strom Thurmond, Walter F. George, System Control, Reactive, and demand is the amount of capacity in Hartwell, Millers Ferry, West Point, Regulation Services provided under this kilowatts stated in the contract which Robert F. Henry, Carters and Richard B. rate schedule shall be the rates charged the Government is obligated to supply Russell Projects and sold under Southeastern Power Administration by and the Customer is entitled to receive. appropriate contracts between the the Company. Future adjustments to Energy To Be Furnished by the Government and the Customer. This rate these rates will become effective upon Government: The Government will sell schedule does not apply to energy from acceptance for filing by the Federal to the Customer and the Customer will

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purchase from the Government energy Energy Charge: 9.32 mills per Wholesale Power Rate Schedule each billing month equivalent to a kilowatt-hour. SCE&G–3–C percentage specified by contract of the Generation Services: $0.12 per Availability: This rate schedule shall energy made available to the company kilowatt of total contract demand per be available public bodies and (less applicable losses). The Customer’s month. cooperatives (any one of which is contract demand and accompanying Additional rates for Transmission, hereinafter called the Customer) in energy will be allocated proportionately South Carolina to whom power may be to its individual delivery points served System Control, Reactive, and Regulation Services provided under this scheduled pursuant to contracts from the Company’s system. between the Government and the South rate schedule shall be the rates charged Billing Month: The billing month for Carolina Electric & Gas Company Southeastern Power Administration by power sold under this schedule shall (hereinafter called the Company). The the Company. Future adjustments to end at 12 midnight on the last day of customer is responsible for providing a these rates will become effective upon each calendar month. transmission arrangement. Nothing in acceptance for filing by the Federal Conditions of Service: The Customer this rate schedule shall preclude an shall at its own expense provide, install, Energy Regulatory Commission of the eligible customer from electing service and maintain on its side of each Company’s rate. under another rate schedule. delivery point the equipment necessary Transmission: $0.85 per kilowatt of Applicability: This rate schedule shall to protect and control its own system. In total contract demand per month is be applicable to the sale at wholesale of so doing, the installation, adjustment, presented for illustrative purposes. power and accompanying energy and setting of all such control and The initial rate will be subject to generated at the Allatoona, Buford, J. protective equipment at or near the monthly adjustment and will be Strom Thurmond, Walter F. George, point of delivery shall be coordinated computed subject to Section 7 of the Hartwell, Millers Ferry, West Point, with that which is installed by and at Government-Company contract. Robert F. Henry, Carters and Richard B. the expense of the Company on its side Russell Projects and sold under of the delivery point. Proceedings before the Federal Energy appropriate contracts between the Regulatory Commission involving the Government and the Customer. This rate Wholesale Power Rate Schedule Company’s Open Access Transmission schedule does not apply to energy from SCE&G–2–C Tariff may result in the separation of pumping operations at the Carters and Availability: This rate schedule shall charges currently included in the Richard B. Russell Projects. be available public bodies and transmission rate. In this event, the Character of Service: The electric cooperatives (any one of which is Government may charge the Customer capacity and energy supplied hereunder hereinafter called the Customer) in for any and all separate transmission will be delivered at the Projects. South Carolina to whom power may be and distribution charges paid by the Monthly Rate: The monthly rate for wheeled pursuant to contracts between Government in behalf of the Customer. capacity, energy, and generation the Government and the South Carolina Contract Demand: The contract services provided under this rate Electric & Gas Company (hereinafter demand is the amount of capacity in schedule for the period specified shall called the Company). The customer is kilowatts stated in the contract that the be: Capacity Charge: $3.70 per kilowatt of responsible for providing a scheduling Government is obligated to supply and total contract demand per month. arrangement with the Government. the Customer is entitled to receive. Nothing in this rate schedule shall Energy Charge: 9.32 mills per Energy To Be Furnished by the preclude an eligible customer from kilowatt-hour. Government: The Government will sell Generation Services: $0.12 per electing service under another rate to the Customer and the Customer will kilowatt of total contract demand per schedule. purchase from the Government energy month. Applicability: This rate schedule shall each billing month equivalent to a Additional rates for Transmission, be applicable to the sale at wholesale of percentage specified by contract of the System Control, Reactive, and power and accompanying energy energy made available to the company Regulation Services provided under this generated at the Allatoona, Buford, J. (less applicable losses). The Customer’s rate schedule shall be the rates charged Strom Thurmond, Walter F. George, contract demand and accompanying Southeastern Power Administration by Hartwell, Millers Ferry, West Point, energy will be allocated proportionately the Company. Future adjustments to Robert F. Henry, Carters and Richard B. to its individual delivery points served these rates will become effective upon Russell Projects and sold under from the Company’s system. acceptance for filing by the Federal appropriate contracts between the Energy Regulatory Commission of the Government and the Customer. This rate Billing Month: The billing month for power sold under this schedule shall Company’s rate. schedule does not apply to energy from Contract Demand: The contract end at 12 midnight on the last day of pumping operations at the Carters and demand is the amount of capacity in each calendar month. Richard B. Russell Projects. kilowatts stated in the contract that the Character of Service: The electric Conditions of Service: The Customer Government is obligated to supply and capacity and energy supplied hereunder shall at its own expense provide, install, the Customer is entitled to receive. will be delivered at the delivery points and maintain on its side of each Energy To Be Furnished by the of the Customer on the Company’s delivery point the equipment necessary Government: The Government will sell transmission and distribution system. to protect and control its own system. In to the Customer and the Customer will Monthly Rate: The monthly rate for so doing, the installation, adjustment, purchase from the Government energy capacity, energy, and generation and setting of all such control and each billing month equivalent to a services provided under this rate protective equipment at or near the percentage specified by contract of the schedule for the period specified shall point of delivery shall be coordinated energy made available to the company be: with that which is installed by and at (less applicable losses). Capacity Charge: $3.70 per kilowatt of the expense of the Company on its side Billing Month: The billing month for total contract demand per month. of the delivery point. power sold under this schedule shall

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end at 12 midnight on the last day of Energy Regulatory Commission of the Where: each calendar month. Company’s rate. Conditions of Service: The Customer Contract Demand: The contract =÷ CCEwav T11 T shall at its own expense provide, install, demand is the amount of capacity in and maintain on its side of each kilowatts stated in the contract that the (The weighted average cost of energy delivery point the equipment necessary Government is obligated to supply and for pumping for this rate schedule is to protect and control its own system. In the Customer is entitled to receive. equal to the cost of energy purchased or so doing, the installation, adjustment, Energy To Be Furnished by the supplied for the benefit of the customer and setting of all such control and Government: The Government will sell for pumping divided by the total energy protective equipment at or near the to the Customer and the Customer will for pumping.) point of delivery shall be coordinated purchase from the Government energy =+ with that which is installed by and at each billing month equivalent to a CCCTps1 the expense of the Company on its side percentage specified by contract of the (Cost of energy for pumping for this of the delivery point. energy made available to the company rate schedule is equal to the cost of (less applicable losses). energy purchased or supplied for the Wholesale Power Rate Schedule Billing Month: The billing month for SCE&G–4–C benefit of the customer plus the cost of power sold under this schedule shall energy in storage carried over from the Availability: This rate schedule shall end at 12 midnight on the last day of month preceding the specified month.) be available public bodies and each calendar month. cooperatives (any one of which is Conditions of Service: The Customer EE=×− ()1 LE+ t−1 hereinafter called the Customer) in shall at its own expense provide, install, Tp1 ps South Carolina served through the and maintain on its side of each (Energy for pumping for this rate transmission facilities of South Carolina delivery point the equipment necessary schedule is equal to the energy Electric & Gas Company (hereinafter to protect and control its own system. In purchased or supplied for the benefit of called the Company). The customer is so doing, the installation, adjustment, the customer, after losses, plus the responsible for providing a scheduling and setting of all such control and energy for pumping in storage as of the arrangement with the Government and protective equipment at or near the end of the month preceding the for providing a transmission point of delivery shall be coordinated specified month.) arrangement. Nothing in this rate with that which is installed by and at schedule shall preclude an eligible the expense of the Company on its side =×t−−11t CCswav Es customer from electing service under of the delivery point. another rate schedule. (Cost of energy in storage is equal to Wholesale Power Rate Schedule the weighted average cost of energy for Applicability: This rate schedule shall Pump–1–A be applicable to the sale at wholesale of pumping for the month preceding the power and accompanying energy Availability: This rate schedule shall specified month times the energy for generated at the Allatoona, Buford, J. be available to public bodies and pumping in storage at the end of the Strom Thurmond, Walter F. George, cooperatives (any one of whom is month preceding the specified month.) Hartwell, Millers Ferry, West Point, hereinafter called the Customer) in Cp = Dollars cost of energy purchased or Robert F. Henry, Carters and Richard B. Georgia, Alabama, Mississippi, Florida, supplied for the benefit of the Russell Projects and sold under South Carolina, or North Carolina to customer for pumping during the appropriate contracts between the whom power is provided pursuant to specified month, including all Government and the Customer. This rate contracts between the Government and direct costs to deliver energy to the schedule does not apply to energy from the customer. project. Applicability: This rate schedule shall pumping operations at the Carters and Ep = Kilowatt-hours of energy purchased Richard B. Russell Projects. be applicable to the sale at wholesale or supplied for the benefit of the Character of Service: The electric energy generated from pumping customer for pumping during the capacity and energy supplied hereunder operations at the Carters and Richard B. specified month. Russell Projects and sold under will be delivered at the Projects. Lp = Energy loss factor for transmission Monthly Rate: The monthly rate for appropriate contracts between the on energy purchased or supplied for capacity, energy, and generation Government and the Customer. The the benefit of the customer for services provided under this rate energy will be segregated from energy pumping (Expected to be .03 or schedule for the period specified shall from other pumping operations. three percent). Character of Service: The energy be: t–1 supplied hereunder will be delivered at E s= Kilowatt-hours of energy in Capacity Charge: $3.70 per kilowatt the delivery points provided for under storage as of the end of the month of total contract demand per month. appropriate contracts between the immediately preceding the Energy Charge: 9.32 mills per Government and the Customer. specified month. kilowatt-hour. t–1 Monthly Rate: The rate for energy sold C wav = Weighted average cost of Generation Services: $0.12 per under this rate schedule for the months energy for pumping for the month kilowatt of total contract demand per specified shall be: immediately preceding the month. specified month. Additional rates for Transmission, ()÷ ÷−() EnergyRate = Cwav Fwav1 L d System Control, Reactive, and FEE=÷ Regulation Services provided under this [computed to the nearest $.00001 (1/100 wav G T rate schedule shall be the rates charged mill) per kwh]. (Weighted average energy conversion Southeastern Power Administration by (The weighted average cost of energy factor is equal to the energy generated the Company. Future adjustments to for pumping divided by the energy from pumping divided by the total these rates will become effective upon conversion factor, quantity divided by energy for pumping). acceptance for filing by the Federal one minus losses for delivery.) EG = Energy generated from pumping.

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Ld = Weighted average energy loss factor for pumping divided by the total energy Ld = Weighted average energy loss factor on energy delivered by the for pumping.) on energy delivered by the Facilitator to the Customer. Facilitator to the Customer. Energy To Be Furnished by the =+ CT2 Cps C Energy To Be Furnished by the Government: The Government will sell Government: The Government will sell to the Customer and the Customer will (Cost of energy for pumping for this to the Customer and the Customer will purchase from the Government energy rate schedule is equal to the cost of purchase from the Government energy each billing month equivalent to a energy purchased or supplied for the each billing month equivalent to a percentage specified by contract of the benefit of the Customer plus the cost of percentage specified by contract of the energy made available to the Facilitator energy in storage carried over from the energy made available to the Facilitator (less any losses required by the month preceding the specified month.) (less any losses required by the Facilitator). The Customer’s contract Facilitator). The Customer’s contract =×−+ t−1 demand and accompanying energy will ELETps2 Ep ()1 demand and accompanying energy will be allocated proportionately to its be allocated proportionately to its individual delivery points served from (Energy for pumping for this rate individual delivery points served from the Facilitator’s system. schedule is equal to the energy the Facilitator’s system. Billing Month: The billing month for purchased or supplied for the benefit of Billing Month: The billing month for power sold under this schedule shall the Customer, after losses, plus the power sold under this schedule shall end at 12 midnight on the last day of energy for pumping in storage as of the end at 12 midnight on the last day of each calendar month. end of the month preceding the each calendar month. specified month.) Wholesale Power Rate Schedule Wholesale Power Rate Schedule Pump–2 =×tt−−11 Replacement–1 Cswavs C E Availability: This rate schedule shall Availability: This rate schedule shall be available to public bodies and (Cost of energy in storage is equal to be available to public bodies and cooperatives who provide their own the weighted average cost of energy for cooperatives (any one of whom is scheduling arrangement and elect to pumping for the month preceding the hereinafter called the Customer) in allow Southeastern to use a portion of specified month times the energy for Georgia, Alabama, Mississippi, Florida, their allocation for pumping (any one of pumping in storage at the end of the South Carolina, or North Carolina to whom is hereinafter called the month preceding the specified month.) whom power is provided pursuant to Customer) in Georgia, Alabama, Cp = Dollars cost of energy purchased or contracts between the Government and Mississippi, Florida, South Carolina, or supplied for the benefit of the the Customer. North Carolina to whom power is Customer for pumping during the Applicability: This rate schedule shall provided pursuant to contracts between specified month, including all be applicable to the sale at wholesale the Government and the Customer. direct costs to deliver energy to the energy purchased to meet contract Applicability: This rate schedule shall project. minimum energy and sold under be applicable to the sale at wholesale Ep = Kilowatt-hours of energy purchased appropriate contracts between the energy generated from pumping or supplied for the benefit of the Government and the Customer. operations at the Carters and Richard B. Customer for pumping during the Character of Service: The energy Russell Projects and sold under specified month. supplied hereunder will be delivered at /MATH> EN20SE07.018 EN20SE07.019 EN20SE07.020 appropriate contracts between the = Energy loss factor for transmission on the delivery points provided for under Government and the Customer. This appropriate contracts between the energy will be segregated from energy energy purchased or supplied for the benefit of the customer for Government and the Customer. from other pumping operations. Monthly Rate: The rate for energy sold Character of Service: The energy pumping (Expected to be .03 or three percent.) under this rate schedule for the months supplied hereunder will be delivered at specified shall be: the delivery points provided for under − appropriate contracts between the t 1 Es =÷−() EnergyRate Cwav 1 L d Government and the Customer. Lp Monthly Rate: The rate for energy sold [computed to the nearest $.00001 (1/100 under this rate schedule for the months = Kilowatt-hours of energy in storage as mill) per kwh]. specified shall be: of the end of the month immediately preceding the (The weighted average cost of energy =÷()÷−() specified month. for replacement energy divided by one EnergyRate Cwav F1Lwav d minus losses for delivery.) − Where: [computed to the nearest $.00001 (1/100 Ct 1 mill) per kwh]. wav = Weighted average cost of energy for =÷ ×− (The weighted average cost of energy CLwav Cpp () E () 1 p for pumping divided by the energy pumping for the month conversion factor, quantity divided by immediately preceding the (The weighted average cost of energy one minus losses for delivery.) specified month. for replacement energy is equal to the cost of replacement energy purchased Where: =÷ divided by the replacement energy FEEwav G T =÷ purchased, net losses.) Cwav CT2 E T2 (Weighted average energy conversion Cp = Dollars cost of energy purchased for (The weighted average cost of energy factor is equal to the energy generated replacement energy during the for pumping for this rate schedule is from pumping divided by the total specified month, including all equal to the cost of energy purchased or energy for pumping.) direct costs to deliver energy to the supplied for the benefit of the customer EG = Energy generated from pumping. project.

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Ep = Kilowatt-hours of energy purchased ENVIRONMENTAL PROTECTION Washington, DC 20460; telephone: (202) for replacement energy during the AGENCY 564–5571; fax number (202) 564–5603; specified month. e-mail address: [email protected]. [FRL–8471–3] Lp = Energy loss factor for transmission SUPPLEMENTARY INFORMATION: on replacement energy purchased Proposed Consent Decree, Clean Air I. Additional Information About the (Expected to be 0 or zero percent.). Act Citizen Suit Proposed Consent Decree L = Weighted average energy loss factor d AGENCY: Environmental Protection Under section 109(d) of the CAA, EPA on energy delivered by the Agency (EPA). is required to periodically review air facilitator to the Customer. ACTION: Notice of Proposed Consent quality criteria and NAAQS and to make Energy To Be Furnished by the Decree; Request for Public Comment. such revisions as may be appropriate. Government: The Government will sell Plaintiffs allege that EPA has failed to to the Customer and the Customer will SUMMARY: In accordance with section do this by the deadline set forth in the purchase from the Government energy 113(g) of the Clean Air Act, as amended CAA. The proposed consent decree each billing month equivalent to a (‘‘Act’’), 42 U.S.C. 7413(g), notice is establishes a schedule for EPA’s review percentage specified by contract of the hereby given of a proposed consent and, if appropriate, revisions of the air energy made available to the Facilitator decree. On February 3, 2006, the Center quality criteria for NOX and SOX and the (less any losses required by the for Biological Diversity and four other NO2 and SO2 NAAQS. The schedule Facilitator). The Customer’s contract plaintiffs (collectively, ‘‘Plaintiffs’’) filed establishes dates for issuance of demand and accompanying energy will an amended complaint alleging that Integrated Science Assessments be allocated proportionately to its EPA failed to perform its mandatory (document containing air quality individual delivery points served from duty under CAA section 109(d)(1) to criteria) addressing the human health the Facilitator’s system. periodically review the air quality effects of NOX, the human health effects Billing Month: The billing month for criteria for nitrogen oxides (‘‘NOX’’) and of SOX, and the public welfare effects of power sold under this schedule shall sulfur oxides (‘‘SOX’’) and the National NOX and SOX. The proposed consent end at 12 midnight on the last day of Ambient Air Quality Standards decree also establishes a schedule for each calendar month. (‘‘NAAQS’’) for nitrogen dioxide EPA’s issuance of notices of proposed (‘‘NO ’’) and sulfur dioxide (‘‘SO ’’), to Wholesale Rate Schedule Regulation–1 2 2 rulemaking and final rules concerning make such revisions to these air quality its review of the primary and secondary Availability: This rate schedule shall criteria and NAAQS as may be NO2 and SO2 NAAQS. The consent be available to public bodies and appropriate, and to promulgate such decree provides that EPA will sign a cooperatives (any one of whom is new NAAQS as may be appropriate. notice setting forth its decision hereinafter called the Customer) in Center for Biological Diversity, et al. v. concerning its review of (1) the primary Georgia, Alabama, Mississippi, Florida, Johnson, No. 05–1814 (D.D.C.). The NO2 NAAQS no later than December 18, South Carolina, or North Carolina to proposed consent decree establishes a 2009; (2) the primary SO2 NAAQS no whom service is provided pursuant to schedule for EPA’s review and, if later than March 2, 2010; and (3) the contracts between the Government and appropriate, revisions of the air quality secondary NO2 and SO2 NAAQS no the Customer. criteria for SOX and NOX and the later than October 19, 2010. Applicability: This rate schedule shall NAAQS for NO2 and SO2 NAAQS. For a period of thirty (30) days be applicable to the sale of regulation DATES: Written comments on the following the date of publication of this services provided from the Allatoona, proposed consent decree must be notice, the Agency will receive written Buford, J. Strom Thurmond, Walter F. received by October 22, 2007. comments relating to the proposed George, Hartwell, Millers Ferry, West ADDRESSES: Submit your comments, consent decree from persons who were Point, Robert F. Henry, Carters, and identified by Docket ID number EPA– not named as parties or intervenors to Richard B. Russell Projects (hereinafter HQ–OGC–2007–0962, online at the litigation in question. EPA or the called the Projects) and sold under www.regulations.gov (EPA’s preferred Department of Justice may withdraw or appropriate contracts between the method); by e-mail to withhold consent to the proposed Government and the Customer. [email protected]; mailed to EPA consent decree if the comments disclose Character of Service: The service Docket Center, Environmental facts or considerations that indicate that supplied hereunder will be delivered at Protection Agency, Mailcode: 2822T, such consent is inappropriate, the Projects. 1200 Pennsylvania Ave., NW., improper, inadequate, or inconsistent Monthly Rate: The rate for service Washington, DC 20460–0001; or by with the requirements of the Act. Unless supplied under this rate schedule for hand delivery or courier to EPA Docket EPA or the Department of Justice the period specified shall be: $0.05 per Center, EPA West, Room 3334, 1301 determines, based on any comment kilowatt of total contract demand per Constitution Ave., NW., Washington, which may be submitted, that consent to month. DC, between 8:30 a.m. and 4:30 p.m. the consent decree should be Contract Demand: The contract Monday through Friday, excluding legal withdrawn, the terms of the decree will demand is the amount of capacity in holidays. Comments on a disk or CD– be affirmed. kilowatts stated in the contract to which ROM should be formatted in Word or II. Additional Information About the Government is obligated to supply ASCII file, avoiding the use of special and the Customer is entitled to receive Commenting on the Proposed Consent characters and any form of encryption, Decree regulation service. and may be mailed to the mailing Billing Month: The billing month for address above. A. How Can I Get A Copy of the Consent services provided under this schedule FOR FURTHER INFORMATION CONTACT: M. Decree? shall end at 12 midnight on the last day Lea Anderson, Air and Radiation Law The official public docket for this of each calendar month. Office (2344A), Office of General action (identified by Docket ID No. [FR Doc. E7–18537 Filed 9–19–07; 8:45 am] Counsel, U.S. Environmental Protection EPA–HQ–OGC–2007–0962) contains a BILLING CODE 6450–01–P Agency, 1200 Pennsylvania Ave., NW., copy of the proposed consent decree.

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The official public docket is available EPA to contact you in case EPA cannot review final rules promulgated by the for public viewing at the Office of read your comment due to technical Environmental Protection Agency (EPA) Environmental Information (OEI) Docket difficulties or needs further information relating to the New Source Performance in the EPA Docket Center, EPA West, on the substance of your comment. Any Standards for Electric Arc Furnaces, 40 Room 3334, 1301 Constitution Ave., identifying or contact information CFR Part 60, Subparts AA and AAa, and NW., Washington, DC. The EPA Docket provided in the body of a comment will the Amendments to Standards of Center Public Reading Room is open be included as part of the comment that Performance for New Stationary from 8:30 a.m. to 4:30 p.m., Monday is placed in the official public docket, Sources: Monitoring Requirements (PS– through Friday, excluding legal and made available in EPA’s electronic 1) 65 FR 48914 (August 10, 2000). holidays. The telephone number for the public docket. If EPA cannot read your Under the terms of the proposed Public Reading Room is (202) 566–1744, comment due to technical difficulties settlement agreement, the EPA would and the telephone number for the OEI and cannot contact you for clarification, execute a letter explaining its position Docket is (202) 566–1752. EPA may not be able to consider your regarding the proper use of continuous An electronic version of the public comment. opacity monitoring system (COMS) data docket is available through Use of the www.regulations.gov Web with respect to the 40 CFR Part 60, www.regulations.gov. You may use the site to submit comments to EPA Subparts AAa and AAa NSPS for www.regulations.gov to submit or view electronically is EPA’s preferred method electric arc furnace (EAF) steel facilities. public comments, access the index for receiving comments. The electronic DATES: Written comments on the listing of the contents of the official public docket system is an ‘‘anonymous proposed settlement agreement must be public docket, and to access those access’’ system, which means EPA will received by October 22, 2007. documents in the public docket that are not know your identity, e-mail address, ADDRESSES: Submit your comments, available electronically. Once in the or other contact information unless you identified by Docket ID number EPA– system, select ‘‘search,’’ then key in the provide it in the body of your comment. HQ–OGC–2007–0961, online at http:// appropriate docket identification In contrast to EPA’s electronic public www.regulations.gov (EPA’s preferred number. docket, EPA’s electronic mail (e-mail) method); by e-mail to It is important to note that EPA’s system is not an ‘‘anonymous access’’ policy is that public comments, whether [email protected]; mailed to EPA system. If you send an e-mail comment Docket Center, Environmental submitted electronically or in paper, directly to the Docket without going will be made available for public Protection Agency, Mailcode: 2822T, through www.regulations.gov, your e- 1200 Pennsylvania Ave., NW., viewing online at www.regulations.gov mail address is automatically captured without change, unless the comment Washington, DC 20460–0001; or by and included as part of the comment hand delivery or courier to EPA Docket contains copyrighted material, CBI, or that is placed in the official public other information whose disclosure is Center, EPA West, Room 3334, 1301 docket, and made available in EPA’s Constitution Ave., NW., Washington, restricted by statute. Information electronic public docket. claimed as CBI and other information DC, between 8:30 a.m. and 4:30 p.m. whose disclosure is restricted by statute Dated: September 14, 2007. Monday through Friday, excluding legal is not included in the official public Richard B. Ossias, holidays. Comments on a disk or CD- docket or in the electronic public Associate General Counsel. ROM should be formatted in Word or docket. EPA’s policy is that copyrighted [FR Doc. E7–18573 Filed 9–19–07; 8:45 am] ASCII file, avoiding the use of special characters and any form of encryption, material, including copyrighted material BILLING CODE 6560–50–P contained in a public comment, will not and may be mailed to the mailing be placed in EPA’s electronic public address above. docket but will be available only in ENVIRONMENTAL PROTECTION FOR FURTHER INFORMATION CONTACT: printed, paper form in the official public AGENCY Sonja Rodman, Air and Radiation Law Office (2344A), Office of General docket. Although not all docket [FRL–8471–1] materials may be available Counsel, U.S. Environmental Protection electronically, you may still access any Proposed Settlement Agreement, Agency, 1200 Pennsylvania Ave., NW., of the publicly available docket Clean Air Act Citizen Suit Washington, DC 20460; telephone: (202) materials through the EPA Docket 564–4079; fax number (202) 564–5603; Center. AGENCY: Environmental Protection e-mail address: [email protected]. Agency (EPA). SUPPLEMENTARY INFORMATION: B. How and To Whom Do I Submit ACTION: Notice of Proposed Settlement Comments? I. Additional Information About the Agreement; Request for Public Proposed Settlement You may submit comments as Comment. provided in the ADDRESSES section. Through this action, EPA is providing Please ensure that your comments are SUMMARY: In accordance with section notice of a proposed settlement submitted within the specified comment 113(g) of the Clean Air Act, as amended agreement to address three petitions for period. Comments received after the (‘‘Act’’), 42 U.S.C. 7413(g), notice is review of EPA actions filed by American close of the comment period will be hereby given of a proposed settlement Iron and Steel Institute (AISI), the marked ‘‘late.’’ EPA is not required to agreement, to address three lawsuits Specialty Steel Industry of North consider these late comments. filed by the American Iron and Steel America (SSINA) and the Steel If you submit an electronic comment, Institute, the Specialty Steel Industry of Manufacturers Association (SMA). Two EPA recommends that you include your North America and the Steel of the petitions for review were filed in name, mailing address, and an e-mail Manufacturers Association. [American October 2000. On or about October 10, address or other contact information in Iron and Steel Institute et. al v. U.S. 2000, Petitioners SSINA and SMA the body of your comment and with any Environmental Protection Agency, No. petitioned the Court for review of the disk or CD–ROM you submit. This 00–1434 consolidated with Nos. 00– ‘‘Amendments to Standards of ensures that you can be identified as the 1435 and 05–1135 (D.C. Cir.)]. In these Performance for New Stationary submitter of the comment and allows cases, petitioners asked the Court to Sources: Monitoring Requirements’’ 65

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FR 48914 (August 10, 2000) (‘‘PS–1 Unless EPA or the Department of Justice B. How and To Whom Do I Submit Rule’’) [Specialty Steel Industry of North determines, based on any comment Comments? America & Steel Manufacturers which may be submitted, that consent to Association v. U.S. Environmental the settlement should be withdrawn, the Direct your comments to the official Protection Agency, No. 00–1434 (D.C. terms of the agreement will be affirmed. public docket for this action under Cir)]. Also on or about October 10, 2000, Docket ID No. EPA–HQ–OGC–2007– Petitioners AISI, SSINA and SMA asked II. Additional Information About 0961. You may submit comments as the Court to review the New Source Commenting on the Proposed provided in the ADDRESSES section. Performance Standards Subparts AA Settlement Please ensure that your comments are and AAa, 40 CFR Part 60, Subparts AA A. How Can I Get a Copy of the submitted within the specified comment and AAa, which they asserted had been Settlement? period. Comments received after the modified by the aforementioned PS–1 close of the comment period will be Rule [American Iron and Steel Institute, The official public docket for this marked ‘‘late.’’ EPA is not required to Specialty Steel Industry of North action—Docket ID No. EPA–HQ–OGC– consider these late comments. American, Steel Manufacturers 2007–0961—contains a copy of the If you submit an electronic comment, Association v. U.S. Environmental settlement agreement. The official EPA recommends that you include your Protection Agency, No. 00–1435 (D.C. public docket is available for public name, mailing address, and an e-mail Cir.)]. The litigation on these two viewing at the Office of Environmental address or other contact information in petitions was stayed pending EPA’s Information (OEI) Docket in the EPA the body of your comment and with any action on a related administrative Docket Center, EPA West, Room 3334, petition. Subsequently, on or about 1301 Constitution Ave., NW., disk or CD–ROM you submit. This April 22, 2005, Petitioners SMA and Washington, DC. The EPA Docket ensures that you can be identified as the AISI petitioned the Court for review of Center Public Reading Room is open submitter of the comment and allows a final rule promulgated by EPA entitled from 8:30 a.m. to 4:30 p.m., Monday EPA to contact you in case EPA cannot ‘‘Standards of Performance for Steel through Friday, excluding legal read your comment due to technical Plants: Electric Arc Furnaces holidays. The telephone number for the difficulties or needs further information Constructed After October 21, 1974, and Public Reading Room is (202) 566–1744, on the substance of your comment. Any before August 17, 1983; and Standards and the telephone number for the OEI identifying or contact information of Performance for Steel Plants: Electric Docket is (202) 566–1752. provided in the body of a comment will Arc Furnaces and Argon-Oxygen be included as part of the comment that An electronic version of the public Decarburization Vessels Constructed docket is available through http:// is placed in the official public docket, After August 17, 1983.’’ 70 FR 8523 www.regulations.gov. You may use the and made available in EPA’s electronic (February 22, 2005) [Steel http://www.regulations.gov to submit or public docket. If EPA cannot read your Manufacturers Association & American view public comments, access the index comment due to technical difficulties Iron and Steel Institute v. U.S. and cannot contact you for clarification, Environmental Protection Agency, No. listing of the contents of the official public docket, and to access those EPA may not be able to consider your 05–1135 (D.C. Cir.)]. These three comment. lawsuits were consolidated into a single documents in the public docket that are action by the United States Court of available electronically. Once in the Use of the http://www.regulations.gov Appeals for the District of Columbia system, select ‘‘search,’’ then key in the Web site to submit comments to EPA Circuit. The proposed settlement appropriate docket identification electronically is EPA’s preferred method agreement would resolve all three number. for receiving comments. The electronic lawsuits. Under the terms of the It is important to note that EPA’s public docket system is an ‘‘anonymous proposed settlement agreement, the EPA policy is that public comments, whether access’’ system, which means EPA will would execute a letter explaining its submitted electronically or in paper, not know your identity, e-mail address, position regarding the proper use of will be made available for public or other contact information unless you continuous opacity monitoring system viewing online at http:// provide it in the body of your comment. (COMS) data with respect to the 40 CFR www.regulations.gov without change, In contrast to EPA’s electronic public Part 60, Subparts AAa and AAa NSPS unless the comment contains docket, EPA’s electronic mail (e-mail) for electric arc furnace (EAF) steel copyrighted material, CBI, or other system is not an ‘‘anonymous access’’ facilities. The text of this letter is information whose disclosure is system. If you send an e-mail comment included in the docket for this restricted by statute. Information directly to the Docket without going rulemaking. claimed as CBI and other information through http://www.regulations.gov, For a period of thirty (30) days whose disclosure is restricted by statute your e-mail address is automatically following the date of publication of this is not included in the official public captured and included as part of the notice, the Agency will receive written docket or in the electronic public comment that is placed in the official comments relating to the proposed docket. EPA’s policy is that copyrighted public docket, and made available in settlement agreement from persons who material, including copyrighted material EPA’s electronic public docket. were not named as parties or contained in a public comment, will not intervenors to the litigation in question. be placed in EPA’s electronic public Dated: September 14, 2007. EPA or the Department of Justice may docket but will be available only in Richard B. Ossias, withdraw or withhold consent to the printed, paper form in the official public Associate General Counsel. proposed settlement agreement if the docket. Although not all docket [FR Doc. E7–18577 Filed 9–19–07; 8:45 am] comments disclose facts or materials may be available BILLING CODE 6560–50–P considerations that indicate that such electronically, you may still access any consent is inappropriate, improper, of the publicly available docket inadequate, or inconsistent with the materials through the EPA Docket requirements of the Clean Air Act. Center.

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FEDERAL COMMUNICATIONS network. It consolidates narrowband Commission, including whether the COMMISSION operations in the upper 12 megahertz of information shall have practical utility; the 700 MHz Public Safety band and (b) the accuracy of the Commission’s Public Information Collection designates the lower 10 megahertz of burden estimate; (c) ways to enhance Approved by Office Of Management that band solely for broadband the quality, utility, and clarity of the and Budget communications. It also shifts the information collected; and (d) ways to public safety spectrum block down by 1 minimize the burden of the collection of September 12, 2007. megahertz in order to avoid interference information on the respondents, SUMMARY: The Federal Communications problems along the border with Canada. including the use of automated Commission (FCC) has received Office This requires relocation of all public collection techniques or other forms of of Management and Budget (OMB) safety narrowband operations in information technology. approval for the following public channels 63 and 68, and the upper 1 information collection pursuant to the DATES: Persons wishing to comment on megahertz of channels 64 and 69. The Paperwork Reduction Act of 1995, this information collection should 700 MHz Second Report and Order Public Law 104–13. An agency may not submit comments November 19, 2007. If requires the winner of the Upper 700 conduct or sponsor and a person is not you anticipate that you will be MHz Band D Block license to pay the required to respond to a collection of submitting comments but find it costs associated with relocating public information unless it displays a difficult to do so within the period of safety narrowband operations to the currently valid control number. time allowed by this notice, you should consolidated channels. It also assigns advise the contact listed below as soon FOR FURTHER INFORMATION CONTACT: Sue responsibility to a newly created Public as possible. Gilgenbach, Federal Communications Safety Broadband Licensee to Commission, 445 12th Street, SW., ADDRESSES: Direct all PRA comments to administer the relocation process Nicholas A. Fraser, Office of Washington, DC 20554, (202) 418–0639 consistent with the requirements and or via e-mail at [email protected]. Management and Budget (OMB), (202) deadlines set forth in 700 MHz Second 395–5887, or via fax at 202–395–5167, SUPPLEMENTARY INFORMATION: Report and Order. This information or via the Internet at OMB Control No.: 3060–1107. collection will identify the actual _ _ OMB Approval Date: 9/11/2007. Nicholas A. [email protected] and numbers of radios and base stations that to [email protected], Federal Expiration Date: 12/31/2007. the winner of the D Block license will Title: Request to state and local public Communications Commission (FCC), be responsible for paying the costs of safety entities for information on Room 1–B441, 445 12th Street, SW., relocating. equipment operating in affected portion Washington, DC 20554. To submit your of 700 MHz public safety spectrum. Federal Communications Commission. comments by e-mail send them to: Form No.: N/A. Marlene H. Dortch, [email protected]. If you would like to Estimated Annual Burden: 94 Secretary. obtain or view a copy of this responses; 1,974 total annual burden [FR Doc. E7–18465 Filed 9–19–07; 8:45 am] information collection after the 60-day hours; an average of 21 hours per BILLING CODE 6712–01–P comment period, you may do so by response. visiting the FCC PRA web page at: Needs and Uses: Pursuant to the http://www.fcc.gov/omd/pra. Commission’s 700 MHz Second Report FEDERAL COMMUNICATIONS FOR FURTHER INFORMATION CONTACT: For and Order (22 FCC Rcd 15289 (2007)), COMMISSION additional information about the this information collection requires information collection(s) send an e-mail every 700 MHz Band public safety Notice of Public Information to [email protected] or contact Judith B. licensee, whether holding individual Collection(s) Being Reviewed by the Herman at 202–418–0214. narrowband authorizations or operating Federal Communications Commission SUPPLEMENTARY INFORMATION: pursuant to a State License, to provide for Extension Under Delegated OMB Control No.: 3060–0658. the following information to the Authority, Comments Requested Title: Section 27.1213, Designated Commission: (1) The total number of September 12, 2007. Entity Provisions of Broadband Radio narrowband mobile and portable Service (BRS). handsets in operation in channels 63 SUMMARY: The Federal Communications Form No.: N/A. and 68, and the upper 1 megahertz of Commission, as part of its continuing Type of Review: Extension of a channels 64 and 69, as of 30 days after effort to reduce paperwork burden, currently approved collection. the date of adoption of its 700 MHz invites the general public and other Respondents: Business or other for- Second Report and Order, (2) the total Federal agencies to take this profit. number of narrowband base stations opportunity to comment on the Number of Respondents: 60 serving these handsets in operation, (3) following information collection(s), as respondents; 60 responses. contact information for each identified required by the Paperwork Reduction Estimated Time Per Response: 1 hour. set of handsets and base stations, as Act of 1995, Public Law 104–13. An Frequency of Response: appropriate, (4) the areas of operation of agency may not conduct or sponsor a Recordkeeping requirement and on the mobile and portable units (such as collection of information unless it occasion reporting requirement. defined by the jurisdictional boundaries displays a currently valid control Obligation to Respond: Required to of the relevant public safety number. No person shall be subject to obtain or retain benefits. departments), and (5) the location, in any penalty for failing to comply with Total Annual Burden: 60 hours. latitude and longitude, of the base a collection of information subject to the Annual Cost Burden: $4,000. stations. Paperwork Reduction Act (PRA) that Privacy Act Impact Assessment: N/A. In order to create a nationwide, does not display a valid control number. Nature and Extent of Confidentiality: interoperable public safety broadband Comments are requested concerning (a) There is no need for confidentiality. network, the 700 MHz Second Report Whether the proposed collection of Needs and Uses: This collection will and Order establishes a public safety information is necessary for the proper be submitted as an extension (no change band plan consistent with such a performance of the functions of the in reporting and/or recordkeeping

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requirements) after this 60-day comment performance of the functions of the Title: Petitions for Assistance in period to Office of Management and Commission, including whether the Resolving E911 Disputes (Second Budget (OMB) in order to obtain the full information shall have practical utility; Memorandum Opinion and Order in CC three-year clearance from them. (b) the accuracy of the Commission’s Docket No. 94–102). Section 27.1213(e) requires winning burden estimate; (c) ways to enhance Form Number: None. bidders who are designated entities the quality, utility, and clarity of the Type of Review: Extension of a (small businesses) to file with its long- information collected; and (d) ways to currently approved collection. form application or statement of minimize the burden of the collection of Respondents: Business or other for- intention, an exhibit which includes information on the respondents, profit, not-for-profit institutions; and eligibility requirements as listed in including the use of automated state, local and tribal government. § 27.213. collection techniques or other forms of Number of Respondents: 50 Section 27.1213(f) requires all holders information technology. respondents; 50 responses. of Basic Trading Areas (BTA) DATES: Written PRA comments should Estimated Time per Response: 1 hour. authorizations acquired by auction that be submitted on or before November 19, Frequency of Response: On occasion claim designated entity status to 2007. If you anticipate that you will be reporting. maintain, at their principle place of submitting comments, but find it Obligation to Respond: Voluntary. business or with their designated agent, difficult to do so within the period of Total Annual Burden: 50 hours. an updated documentary file of time allowed by this notice, you should Total Annual Cost: Not applicable. ownership and revenue information advise the contact listed below as soon Privacy Act Impact Assessment: Not necessary to establish their status. applicable. All BTA authorization holders as possible. ADDRESSES: You may submit all PRA Nature and Extent of Confidentiality: claiming eligibility under designated No confidentiality is required for this entity provisions are subject to audits comments by e-mail or U.S. mail. To submit your comments by e-mail, send collection. under § 27.1213(g). Selection for an Needs and Uses: In an effort to audit may be random, on information them to [email protected]. To submit your minimize delays in Enhanced 911 rules from any source, or on the basis of other comments by U.S. mail, send them to implementation, the Second factors. These audits may include Jerry Cowden, Federal Communications Memorandum Opinion and Order (FCC inspection of the BTA holders’ books, Commission, Room 1–B135, 445 12th 99–352) at paragraphs 91 and 92, documents and other materials Street, SW., Washington, DC 20554. provides that, in the case of disputes sufficient to confirm that such holders’ FOR FURTHER INFORMATION CONTACT: For between wireless carriers and public representations are, and remain, additional information about the safety answering points (PSAPs) accurate. information collection(s), contact Jerry regarding E911 transmission methods or Federal Communications Commission. Cowden via e-mail at [email protected] or call (202) 418–0447. other technology, the parties involved Marlene H. Dortch, may petition for Commission assistance Secretary. SUPPLEMENTARY INFORMATION: in resolving their dispute. Thus, in OMB Control No.: 3060–0166. [FR Doc. E7–18466 Filed 9–19–07; 8:45 am] order for the Commission to participate Title: Part 42—Preservation of BILLING CODE 6712–01–P in negotiations, petitioners will have to Records of Communications Common provide the Commission with certain Carriers. data concerning the dispute. FEDERAL COMMUNICATIONS Form Number: None. Federal Communications Commission. COMMISSION Type of Review: Extension of a currently approved collection. Marlene H. Dortch, Notice of Public Information Respondents: Business or other for- Secretary. Collections Being Reviewed by the profit. [FR Doc. E7–18583 Filed 9–19–07; 8:45 am] Federal Communications Commission Number of Respondents: 56 BILLING CODE 6712–01–P for Extension Under Delegated respondents; 56 responses. Authority, Comments Requested Estimated Time per Response: 2 hours. FEDERAL RESERVE SYSTEM September 17, 2007. Frequency of Response: SUMMARY: The Federal Communications Recordkeeping, on occasion reporting Formations of, Acquisitions by, and Commission, as part of its continuing and third party disclosure requirements. Mergers of Bank Holding Companies effort to reduce paperwork burden Obligation to Respond: Mandatory. invites the general public and other Total Annual Burden: 112 hours. The companies listed in this notice Federal agencies to take this Total Annual Cost: None. have applied to the Board for approval, opportunity to comment on the Privacy Act Impact(s) Assessment: pursuant to the Bank Holding Company following information collection(s), as Not applicable. Act of 1956 (12 U.S.C. 1841 et seq.) required by the Paperwork Reduction Nature and Extent of Confidentiality: (BHC Act), Regulation Y (12 CFR Part Act (PRA) of 1995, Public Law 104–13. No confidentiality is required for this 225), and all other applicable statutes An agency may not conduct or sponsor collection. and regulations to become a bank a collection of information unless it Needs and Uses: Part 42 prescribes holding company and/or to acquire the displays a currently valid control the regulations governing the assets or the ownership of, control of, or number. No person shall be subject to preservation of records of the power to vote shares of a bank or any penalty for failing to comply with communications common carriers that bank holding company and all of the a collection of information subject to the are fully subject to the jurisdiction of banks and nonbanking companies Paperwork Reduction Act (PRA) that the FCC. The requirements are owned by the bank holding company, does not display a valid control number. necessary to ensure the availability of including the companies listed below. Comments are requested concerning (a) carrier records needed by Commission The applications listed below, as well whether the proposed collection of staff for regulatory purposes. as other related filings required by the information is necessary for the proper OMB Control No.: 3060–0939. Board, are available for immediate

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inspection at the Federal Reserve Bank FEDERAL RESERVE SYSTEM Governors of the Federal Reserve System, indicated. The application also will be Washington, DC 20551. Government in the Sunshine; Meeting available for inspection at the offices of FOR FURTHER INFORMATION CONTACT: Notice the Board of Governors. Interested Michelle Smith, Director, or Dave persons may express their views in AGENCY HOLDING THE MEETING: Board of Skidmore, Assistant to the Board, Office writing on the standards enumerated in Governors of the Federal Reserve of Board Members at 202–452–2955. the BHC Act (12 U.S.C. 1842(c)). If the System. SUPPLEMENTARY INFORMATION: You may proposal also involves the acquisition of TIME AND DATE: call 202–452–3206 for a recorded a nonbanking company, the review also 9:30 a.m., Monday, September 24, 2007. announcement of this meeting; or you includes whether the acquisition of the may contact the Board’s Web site at PLACE: Marriner S. Eccles Federal nonbanking company complies with the http://www.federalreserve.gov for an Reserve Board Building, 20th Street standards in section 4 of the BHC Act electronic announcement. (The Web site entrance between Constitution Avenue (12 U.S.C. 1843). Unless otherwise also includes procedural and other and C Streets, NW., Washington, DC noted, nonbanking activities will be information about the open meeting.) 20551. conducted throughout the United States. Dated: September 17, 2007. Additional information on all bank STATUS: Open. We ask that you notify us in advance Robert deV. Frierson, holding companies may be obtained Deputy Secretary of the Board. from the National Information Center if you plan to attend the open meeting [FR Doc. 07–4683 Filed 9–17–07; 4:41 pm] website at www.ffiec.gov/nic/. and provide your name, date of birth, and social security number (SSN) or BILLING CODE 6210–01–P Unless otherwise noted, comments passport number. You may provide this regarding each of these applications information by calling (202) 452–2474 must be received at the Reserve Bank or you may register online. You may OFFICE OF GOVERNMENT ETHICS indicated or the offices of the Board of pre-register until close of business Governors not later than October 15, September 21, 2007. You also will be Updated OGE Senior Executive Service 2007. asked to provide identifying Performance Review Board information, including a photo ID, A. Federal Reserve Bank of New AGENCY: Office of Government Ethics York (Anne MacEwen, Bank before being admitted to the Board (OGE). meeting. The Public Affairs Office must Applications Officer) 33 Liberty Street, ACTION: Notice. New York, New York 10045–0001: approve the use of cameras; please call (202) 452–2955 for further information. SUMMARY: Notice is hereby given of the 1. JPMorgan Chase & Co., New York, If you need an accommodation for a New York; to acquire control of appointment of members of the updated disability, please contact Penelope OGE Senior Executive Service (SES) JPMorgan Chase Bank, National Beattie on 202–452–3982. For the Performance Review Board. Association, San Francisco, California. hearing impaired only, please use the EFFECTIVE DATE: September 20, 2007. B. Federal Reserve Bank of Cleveland Telecommunication Device for the Deaf FOR FURTHER INFORMATION CONTACT: (Douglas A. Banks, Vice President) 1455 (TDD) on 202–263–4869. Daniel D. Dunning, Deputy Director for East Sixth Street, Cleveland, Ohio Privacy Act Notice: Providing the Administration and Information 44101–2566: information requested is voluntary; however, failure to provide your name, Management, Office of Government 1. Wesbanco, Inc., Wheeling, West date of birth, and social security number Ethics, Suite 500, 1201 New York Virginia; to merge with Oak Hill or passport number may result in denial Avenue, NW., Washington, DC 20005– Financial, Inc., and thereby indirectly of entry to the Federal Reserve Board. 3917; Telephone: 202–482–9300; TDD: acquire Oak Hills Banks, both of This information is solicited pursuant to 202–208–9293; FAX: 202–482–9237. Jackson, Ohio. In connection with this Sections 10 and 11 of the Federal SUPPLEMENTARY INFORMATION: 5 U.S.C. application, Wesbanco has applied to Reserve Act and will be used to 4314(c) requires each agency to acquire Oak Hill Financial Services, facilitate a search of law enforcement establish, in accordance with Inc., Jackson, Ohio, and thereby engage databases to confirm that no threat is regulations prescribed by the Office of in securities brokerage activities, posed to Board employees or property. Personnel Management at 5 CFR part pursuant to section 225.28(b)(7)(i) of It may be disclosed to other persons to 430, subpart C and § 430.310 thereof in Regulation Y. evaluate a potential threat. The particular, one or more Senior Executive C. Federal Reserve Bank of Atlanta information also may be provided to law Service performance review boards. As (David Tatum, Vice President) 1000 enforcement agencies, courts and others, a small executive branch agency, OGE has just one board. In order to ensure an Peachtree Street, N.E., Atlanta, Georgia but only to the extent necessary to adequate level of staffing and to avoid 30309: investigate or prosecute a violation of law. a constant series of recusals, the 1. Atlantic Southern Financial Group, MATTERS TO BE CONSIDERED: designated members of OGE’s SES Inc., Macon, Georgia; to acquire 100 Discussion Agenda: Performance Review Board are being percent of the voting shares of 1. Final joint rules implementing the drawn, as in the past, in large measure CenterState Bank Mid Florida, Leesburg, ‘‘broker’’ exceptions for banks under the from the ranks of other agencies. The Florida. Gramm-Leach-Bliley Act. board shall review and evaluate the Board of Governors of the Federal Reserve initial appraisal of each OGE senior Note: This meeting will be recorded for the executive’s performance by his or her System, September 17, 2007. benefit of those unable to attend. Cassettes supervisor, along with any Robert deV. Frierson, will then be available for listening in the Board’s Freedom of Information Office, and recommendations in each instance to Deputy Secretary of the Board. copies can be ordered for $6 per cassette by the appointing authority relative to the [FR Doc. E7–18559 Filed 9–19–07; 8:45 am] calling 202–452–3684 or by writing to: performance of the senior executive. BILLING CODE 6210–01–S Freedom of Information Office, Board of This notice updates the membership of

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OGE’s SES Performance Review Board DEPARTMENT OF HEALTH AND ACTION: Notice. as it was last published at 71 FR 71548– HUMAN SERVICES SUMMARY: 71549 (December 11, 2006). The Food and Drug Administration for Children and Administration (FDA) is announcing Approved: September 12, 2007. Families that a proposed collection of Robert I. Cusick, information has been submitted to the Director, Office of Government Ethics. Re-allotment of FY 2006 Funds for the Office of Management and Budget Low Income Home Energy Assistance (OMB) for review and clearance under The following officials have been Program (LIHEAP) the Paperwork Reduction Act of 1995. selected as regular members of the SES DATES: Fax written comments on the AGENCY: Office of Community Services, Performance Review Board of the Office collection of information by October 22, ACF, HHS. of Government Ethics: 2007. ACTION: Notice of determination Marilyn L. Glynn [Chair], General ADDRESSES: To ensure that comments on concerning funds available for Counsel, Office of Government Ethics; the information collection are received, reallotment. Daniel D. Dunning [Alternate Chair], OMB recommends that written Deputy Director for Administration and C.F.D.A. Number: 93.568. comments be faxed to the Office of Information Management, Office of SUMMARY: In accordance with Section Information and Regulatory Affairs, Government Ethics; 2607(b)(1) of the Low Income Home OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to Rosalind A. Knapp, Deputy General Energy Assistance Act (the Act), Title [email protected]. All comments Counsel, Department of Transportation; XXVI of the Omnibus Budget Reconciliation Act of 1981 (42 U.S.C. should be identified with the OMB Daniel L. Koffsky, Special Counsel, 8621, et seq.), as amended, a notice was control number 0910–0073. Also Office of Legal Counsel, Department of published in the Federal Register on include the FDA docket number found Justice; and August 1, 2007 announcing the in brackets in the heading of this David Maggi, Chief, Ethics Law and Secretary’s preliminary determination document. Programs Division, Office of the that $326,894 in Fiscal Year (FY) 2006 FOR FURTHER INFORMATION CONTACT: Assistant General Counsel for funds may be available for re-allotment. Denver Presley, Jr., Office of the Chief Administration, Department of After a 30-day comment period, this Information Officer (HFA–250), Food Commerce. amount has not changed. This notice and Drug Administration, 5600 Fishers announces that $326,894 will be re- Lane, Rockville, MD 20857, 301–827– [FR Doc. E7–18518 Filed 9–19–07; 8:45 am] allotted to current Low Income Home 1472. BILLING CODE 6345–02–P Energy Assistance Program (LIHEAP) SUPPLEMENTARY INFORMATION: In grantees. compliance with 44 U.S.C. 3507, FDA Pursuant to the statute cited above, has submitted the following proposed funds will be re-allotted to LIHEAP collection of information to OMB for GOVERNMENT PRINTING OFFICE grantees based upon the normal review and clearance: allocation formula as if the funds had Depository Library Council to the been appropriated for FY 2007. No Medical Devices: Current Good Public Printer; Meeting subgrantees or other entities may apply Manufacturing Practice Quality System for these funds. Regulations—21 CFR Part 820 (OMB The Depository Library Council to the FOR FURTHER INFORMATION CONTACT: Nick Control Number 0910–0073)—Extension Public Printer (DLC) will meet on St. Angelo, Director, Division of Energy Under section 520(f) of the Federal Monday, October 15, 2007, through Assistance, Office of Community Wednesday, October 17, 2007, at Food, Drug, and Cosmetic Act (the act) Services, 370 L’Enfant Promenade, SW., (21 U.S.C. 360j(f)), the Secretary of the Doubletree Hotel Crystal City, located at Washington, DC 20447; telephone (202) Department of Health and Human Arlington, Virginia. The sessions will 401–9351. Services (the Secretary) has the take place from 8 a.m. to 5 p.m. Monday authority to prescribe regulations through Wednesday. The meeting will Dated: September 13, 2007. requiring that the methods used in, and be held at the Doubletree Hotel Crystal Josephine B. Robinson, Director, Office of Community Services. the facilities and controls used for, the City, 300 Army Navy Drive, Arlington, manufacture, pre-production design [FR Doc. E7–18580 Filed 9–19–07; 8:45 am] Virginia. The purpose of this meeting is validation (including a process to assess to discuss the Federal Depository BILLING CODE 4184–01–P the performance of a device but not Library Program. All sessions are open including an evaluation of the safety to the public. The sleeping rooms and effectiveness of a device), packing, available at the Doubletree Hotel Crystal DEPARTMENT OF HEALTH AND HUMAN SERVICES storage, and installation of a device City will be at the Government rate of conform to current good manufacturing $ 201.00 (plus applicable state and local Food and Drug Administration practices (CGMPs), as described in such taxes, currently 10.25%) a night for a regulations, to assure that the device single or double. The Doubletree Hotel [Docket No. 2007N–0229] will be safe and effective and otherwise Crystal City is in compliance with the Agency Information Collection in compliance with the act. requirements of Title III of the Activities; Submission for Office of The CGMP/Quality System (CGMP/ Americans With Disabilities Act and Management and Budget Review; QS) regulation implementing authority meets all Fire Safety Act regulations. Comment Request; Medical Devices: provided by this statutory provision is found under part 820 (21 CFR part 820) William H. Turri, Current Good Manufacturing Practice Quality System Regulations and sets forth basic CGMP requirements Acting, Public Printer of the United States. governing the design, manufacture, [FR Doc. E7–18505 Filed 9–19–07; 8:45 am] AGENCY: Food and Drug Administration, packing, labeling, storage, installation, BILLING CODE 1520–01–P HHS. and servicing of all finished medical

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devices intended for human use. The before implementation of changes; and controlling validated processes; and (7) authority for this regulation is covered (10) the records and references records of the results of revalidation under the act , i.e. 21 U.S.C. 351, 352, constituting the DHF for each type of where necessitated by process changes 360, 360c, 360d, 360e, 360h, 360i, 360j, device. or deviations. 360l, 371, 374, 381, and 383. Section 820.40 requires manufacturers Sections 820.80(a) through (e) and The CGMP/QS regulation includes to establish and maintain procedures 820.86 require, respectively, the requirements for purchasing and service controlling approval and distribution of establishment, maintenance, and/or controls, clarifies recordkeeping required documents and document documentation of the following topics: requirements for device failure and changes. (1) Procedures for incoming acceptance complaint investigations, clarifies Section 820.40(a) and (b) requires the by inspection, test or other verification; requirements for verifying/validating establishment and maintenance of (2) procedures for ensuring that in- production processes and process or procedures for the review, approval, process products meet specified product changes, and clarifies issuance and documentation of required requirements and the control of product requirements for product acceptance records (documents) and changes to until inspection and tests are activities quality data evaluations and those records. completed; (3) procedures for, and corrections of nonconforming product/ Section 820.50(a)(1), (a)(2), (a)(3), and records that show, incoming acceptance quality problems. (b) requires the establishment and or rejection is conducted by inspections, Requirements are compatible with maintenance of procedures and tests or other verifications; (4) specifications in International requirements to ensure service and procedures for, and records that show, Standards, ‘‘ISO 9001: ‘‘Quality Systems product quality, records of acceptable finished devices meet acceptance Model for Quality Assurance in Design/ suppliers, and purchasing data criteria and are not distributed until Development, Production, Installation, describing specified requirements for device master record (DMR) activities and Servicing.’’ The CGMP/QS products and services. are completed; (5) records in the device information collections will assist FDA Sections 820.60 and 820.65 require, history record (DHR) showing inspections of manufacturers for respectively, the establishment and acceptance dates, results and equipment compliance with QS requirements maintenance of procedures for used; and (6) the acceptance/rejection encompassing design, production, identifying all products from receipt to identification of products from receipt installation, and servicing processes. distribution and for using control to installation and servicing. Section 820.20(a) through (e) requires numbers to track surgical implants and Sections 820.90(a), (b)(1), (b)(2), and management with executive life-sustaining or supporting devices 820.100 require, respectively, the responsibility to establish, maintain, and their components. establishment, maintenance and/or and/or review the following topics: (1) Section 820.70(a)(1) through (a)(5), (b) documentation of the following topics: The quality policy, (2) the through (e), (g)(1) through (g)(3), (h), and (1) Procedures for identifying, organizational structure, (3) the quality (i) requires the establishment, recording, evaluating, and disposing of plan, and (4) the QS procedures of the maintenance, and/or documentation of nonconforming product; (2) procedures organization. the following topics: (1) Process control for reviewing and recording concessions Section 820.22 requires the conduct procedures; (2) procedures for verifying made for, and disposition of, and documentation of QS audits and re- or validating changes to specification, nonconforming product; (3) procedures audits. method, process, or procedure; (3) for reworking products, evaluating Section 820.25(b) requires the procedures to control environmental possible adverse rework effect and establishment of procedures to identify conditions and inspection result recording results in the DHR; (4) training needs and documentation of records; (4) requirements for personnel procedures and requirements for such training. hygiene; (5) procedures for preventing corrective and preventive actions, Section 820.30(a)(1) and (b) through contamination of equipment and including analysis, investigation, (j), requires in respective order, the products; (6) equipment adjustment, identification and review of data, establishment, maintenance, and/or cleaning, and maintenance schedules; records, causes and results; and (5) documentation of the following topics: (7) equipment inspection records; (8) records for all corrective and preventive (1) Procedures to control design of class equipment tolerance postings; action activities. III and class II devices, and certain class procedures for utilizing manufacturing Section 820.100(a)(1) through (a)(7) I devices as listed therein; (2) plans for materials expected to have an adverse states that procedures and requirements design and development activities and effect on product quality; and (9) shall be established and maintained for updates; (3) procedures identifying, validation protocols and validation corrective/preventive actions, including documenting, and approving design records for computer software and the following: (1) Analysis of data from input requirements; (4) procedures software changes. process, work, quality, servicing defining design output, including Sections 820.72(a), (b)(1), and (b)(2) records; investigation of acceptance criteria, and documentation and 820.75(a) through (c) require, nonconformance causes; (2) of approved records; (5) procedures for respectively, the establishment, identification of corrections and their formal review of design results and maintenance, and/or documentation of effectiveness; (3) recording of changes documentation of results in the design the following topics: (1) Equipment made; and (4) appropriate distribution history file (DHF); (6) procedures for calibration and inspection procedures; and managerial review of corrective and verifying device design and (2) national, international or in-house preventive action information. documentation of results and approvals calibration standards; (3) records that Section 820.120 states that in the DHF; (7) procedures for validating identify calibrated equipment and next manufacturers shall establish/maintain device design, including documentation calibration dates; (4) validation procedures to control labeling storage/ of results in the DHF; (8) procedures for procedures and validation results for application; and examination/release for translating device design into processes not verifiable by inspections storage and use, and document those production specifications; (9) and tests; (5) procedures for keeping procedures. procedures for documenting, verifying, validated processes within specified Sections 820.120(b) and (d), 820.130, validating approved design changes limits; (6) records for monitoring and 820.140, 820.150(a) and (b), 820.160(a)

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and (b), and 820.170(a) and (b), reports that record the device, service compliance with CGMP design control respectively, require the establishment, activity, and test and inspection data. requirements should decrease the maintenance, and/or documentation of Section 820.250 requires the number of design-related device failures the following topics: (1) Procedures for establishment and maintenance of that have resulted in deaths and serious controlling and recording the storage, procedures to identify valid statistical injuries. techniques necessary to verify process examination, release and use of labeling; The CGMP/QS regulation applies to and product acceptability; and sampling (2) the filing of labels/labeling used in approximately 8,963 respondents. These plans, when used, that are written and the DHR; (3) procedures for controlling recordkeepers consist of 8,945 original based on valid statistical rationale, and product storage areas and receipt/ respondents and an estimated 18 dispatch authorizations; (4) procedures procedures for ensuring adequate hospitals which remanufacture or reuse controlling the release of products for sampling methods. SUDs. They include manufacturers, distribution; (5) distribution records that The CGMP/QS regulation amends and subject to all requirements and contract identify consignee, product, date, and revises the CGMP requirements for manufacturers, specification developers, control numbers; and (6) instructions, medical devices set out under part 820. repackers, relabelers and contract inspection and test procedures that are The regulation adds design and sterilizers, subject only to requirements made available, and the recording of purchasing controls; modifies previous applicable to their activities. Hospital results for devices requiring installation. critical device requirements; revises Sections 820.180(b) and (c), previous validation and other remanufacturers of SUDs are now 820.181(a) through (e), 820.184(a) requirements; and harmonizes device defined to be manufacturers under through (f), and 820.186 require, CGMP requirements with QS guidelines issued by FDA’s Center for respectively, the maintenance of records specifications in the international Devices and Radiological Health’s that are: (1) Retained at prescribed standard, ‘‘ISO 9001: Quality Systems (CDRH), Office of Surveillance and site(s), made readily available and Model for Quality Assurance in Design/ Biometrics. Respondents to this accessible to FDA and retained for the Development Production, Installation collection have no reporting activities, device’s life expectancy or for 2 years; and Servicing.’’ The rule does not apply but must make required records (2) contained or referenced in a DMR to manufacturers of components or parts available for review or copying during consisting of device, process, quality of finished devices, nor to FDA inspection. The regulation contains assurance, packaging and labeling, and manufacturers of human blood and additional recordkeeping requirements installation, maintenance, and servicing blood components subject to 21 CFR in such areas as design control, specifications and procedures; (3) part 606. With respect to devices purchasing, installation, and contained in a DHR and demonstrate the classified in class I, design control information relating to the manufacture of each unit, lot or batch of requirements, apply only to class I remanufacture of SUDs. The estimates product in conformance with DMR and devices listed in § 820.30(a)(2) of the for this burden are derived from those regulatory requirements, include regulation. The rule imposes burden incremental tasks that were determined manufacturing and distribution dates, upon: (1) Finished device manufacturer when the new CGMP/QS regulation quantities, acceptance documents, firms which are subject to all became final as well as those carryover labels and labeling, control numbers; recordkeeping requirements; (2) requirements. The carryover and (4) contained in a quality system finished device contract manufacturers; requirements are based on decisions record (QSR), consisting of references, specification developers; and (3) made by the agency on July 16, 1992, documents, procedures and activities repacker, relabelers and contract under OMB clearance submission 0910– not specific to particular devices. sterilizer firms, which are subject only 0073, which still provides valid baseline Sections 820.198(a) through (c) and to requirements applicable to their data. 820.200(a) through (d), respectively, activities. In addition, re-manufacturers FDA estimates respondents will have requires the establishment, maintenance of hospital single-use devices (SUDs) a total annual recordkeeping burden of and/or documentation of the following will now be considered to have the approximately 3,076,370 hours. This topics: (1) Complaint files and same requirements as manufacturers in figure also consists of approximately procedures for receiving, reviewing, and regard to this regulation. The 143,052 hours spent on a startup basis evaluating complaints; (2) complaint establishment, maintenance and/or by 650 new firms. investigation records identifying the documentation of procedures, records device, complainant, and relationship of and data required by this regulation will In the Federal Register of Monday, the device to the incident; (3) complaint assist FDA in determining whether July 9, 2007, FDA published a 60-day records that are reasonably accessible to firms are in compliance with CGMP notice soliciting public comments on the manufacturing site or at prescribed requirements, which are intended to the information collection requirements sites; (4) procedures for performing and ensure that devices meet their design, for the proposed extension of this verifying that device servicing production, labeling, installation, and collection of information. In response to requirements are met and that service servicing specifications and, thus are that notice, no comments were received. reports involving complaints are safe, effective and suitable for their FDA estimates the burden for this processed as complaints; and (5) service intended purpose. In particular, collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of Annual Frequency Total Annual Hours Per CFR Section Recordkeepers of Recordkeeping Hours Recordkeeper Total Hours

820.20(a) 8,963 1 8,963 6.58 58,977

820.20(b) 8,963 1 8,963 4.43 39,706

820.20(c) 8,963 1 8,963 6 .17 55,302

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TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

No. of Annual Frequency Total Annual Hours Per CFR Section Recordkeepers of Recordkeeping Hours Recordkeeper Total Hours

820.20(d) 8,963 1 8,963 9.89 88,644

820.20(e) 8,963 1 8,963 9.89 88,644

820.22 8,963 1 8,963 32 .72 293,269

820.25(b) 8,963 1 8,963 12.68 113,651

820.30(a)(1) 8,963 1 8,963 1 .75 15,685

820.30(b) 8,963 1 8,963 5.95 53,330

820.30(c) and (d) 8,963 1 8,963 1.75 15,685

820.30(e) 8,963 1 8,963 23.39 209,645

820.30(f) and (g) 8,963 1 8,963 37 .42 335,395

820.30(h) 8,963 1 8,963 3.34 29,936

820.30(i) 8,963 1 8,963 17 .26 154,701

820.30(j) 8,963 1 8,963 2.64 23,662

820.40 8,963 1 8,963 8.91 79,860

820.40(a)and (b) 8,963 1 8,963 2.04 18,285

820.50(a)(1) through (a)(3) 8,963 1 8,963 21 .90 196,290

820.50(b) 8,963 1 8,963 6.02 53,957

820.6 8,963 1 8,963 0 .32 2,868

820.65 8,963 1 8,963 0.67 6,005

820.70(a)(1) through (a)(5), (b), and (c) 8,963 1 8,963 1.85 16,582

820.70(d) 8,963 1 8,963 2.87 25,724

820.70(e) 8,963 1 8,963 1.85 16,582

820.70(g)(1) through (g)(3) 8,963 1 8,963 1.43 12,817

820.70(h) 8,963 1 8,963 1.85 16,582

820.70(i) 8,963 1 8,963 7.50 67,223

820.72(a) 8,963 1 8,963 4.92 44,098

820.72(b)(1) and (b)(2) 8,963 1 8,963 1.43 12,817

820.75(a) 8,963 1 8,963 2.69 24,110

820.75(b) 8,963 1 8,963 1.02 9,142

820.75(c) 8,963 1 8,963 1 .11 9,949

820.80(a) through (e) 8,963 1 8,963 4 .80 43,022

820.86 8,963 1 8,963 0.79 7,081

820.90(a), (b)(1), and (b)(2) 8,963 1 8,963 4.95 44,367

820.100 (a)(1) through (a)(7) 8,963 1 8,963 12 .48 111,858

820.100(b) 8,963 1 8,963 1.28 11,473

820.120(b) and (d) 8,963 1 8,963 0 .45 4,033

820.130 8,963 1 8,963 0 .45 4,033

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TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

No. of Annual Frequency Total Annual Hours Per CFR Section Recordkeepers of Recordkeeping Hours Recordkeeper Total Hours

820.140 8,963 1 8,963 6 .34 56,825

820.150(a) and (b) 8,963 1 8,963 5 .67 50,820

820.160(a) and (b) 8,963 1 8,963 0 .67 6,005

820.170(a) and (b) 8,963 1 8,963 1 .50 13,445

820.180(b) and (c) 8,963 1 8,963 1.50 13,445

820.181(a) through (e) 8,963 1 8,963 1.21 10,845

820.184(a) through (f) 8,963 1 8,963 1 .41 12,638

820.186 8,963 1 8,963 0 .40 3,585

820.198(a) through (c) 8,963 1 8,963 4 .94 44,277

820.200(a) and (d) 8,963 1 8,963 2 .61 23,393

820.25 8,963 1 8,963 0.67 6,005

Totals 3,072,337 1There are no capital costs or operating and maintenance costs associated with this collection of information.

Burden (labor) hour and cost of firm subject to each requirement was DEPARTMENT OF HEALTH AND estimates were originally developed identified by ERG. HUMAN SERVICES under FDA contract by Eastern Research FDA estimates the burden hours (and Food and Drug Administration Group, Inc. (ERG), in 1996 when the costs) based on the last approved CGMP/QS regulation became final. renewal for this information collection. Educational Workshops on Current These figures are still accurate. Good Manufacturing Practices; Public Additional factors considered in FDA estimates that some 650 ‘‘new’’ Workshops deriving estimates included: establishments (marketing devices for the first time) will expend some 143,052 • Establishment Type: Query has AGENCY: Food and Drug Administration, ‘‘development’’ hours on a one-time HHS. been made of CDRH’s registration/ startup basis to develop records and listing databank and has counted 8,963 ACTION: Notice of public workshops. procedures for the CGMP/QS regulation. domestic firms subject to CGMPs. In SUMMARY: The Food and Drug addition, hospitals which reuse or FDA estimates that annual labor hours are apportioned as follows: 40 percent Administration (FDA) is announcing a remanufacture devices are now series of educational workshops on goes to requirements dealing with considered manufacturers under new quality pharmaceutical production manufacturing specifications, process FDA guidance. After investigations of under current good manufacturing many hospitals and the changes in controls and the DHR; 20 percent goes practice (CGMP). The workshops, which enforcements of FDA’s requirements for to requirements dealing with will be held in collaboration with the hospitals, the number of reuse or components and acceptance activities; Parenteral Drug Association (PDA), are remanufactures of SUDs have decreased 25 percent goes to requirements dealing intended to educate participants on from the estimated 66 to an estimated 18 with equipment, records (the DMR and current methods for compliance with hospitals. Because the total number of QSR), complaint investigations, good manufacturing practices (GMP). registered firms is not static, the number labeling/packaging and reprocessing/ The workshops are being offered to help of respondents will fluctuate from year investigating product nonconformance; ensure effective CGMP programs and to to year resulting in slight changes to the and 15 percent goes to quality audit, further the common goals of FDA and overall burden. Currently, there are traceability, handling, distribution, providers of quality pharmaceutical 8,963 firms subject to the CGMPs; an statistical, and other requirements. products. increase from the last renewal of 8,254. Dated: September 14, 2007. DATES: See table 1 in the SUPPLEMENTARY • Potentially Affected Establishments: Jeffrey Shuren, INFORMATION section of this document. Except for manufacturers, not every type Assistant Commissioner for Policy. ADDRESSES: See table 1 in the of firm is subject to every CGMP/QS SUPPLEMENTARY INFORMATION [FR Doc. E7–18582 Filed 9–19–07; 8:45 am] section of requirement. For example, all are this document. BILLING CODE 4160–01–S subject to FDA’s quality policy FOR FURTHER INFORMATION CONTACT: regulations (§ 820.20(a)), document Erik N. Henrikson, Center for Drug control regulations (§ 820.40), and other Evaluation and Research (HF–18), requirements, whereas only Food and Drug Administration, manufacturers and specification 5600 Fishers Lane, Rockville, MD developers are subject to FDA’s design 20857, 301–827–9190, controls regulations (§ 820.30). The type [email protected], or

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Wanda Neal, Parenteral Drug I. General Information affairs professionals, consultants, Association, 4350 East West Hwy., regulatory investigators, and CGMP A. Who Should Attend? suite 200, Bethesda, MD 20814, compliance officials. Other entities or 301–656–5900, FAX: 301–986– This announcement is directed individuals may also be interested in 0296, [email protected]. towards professionals involved in the attending. manufacture, control, and regulation of SUPPLEMENTARY INFORMATION: pharmaceutical products who will B. Where and When Will These benefit from these workshops, including Workshops Be Held? process/production engineers, We have scheduled four workshops. manufacturing personnel, quality The locations and times are listed in assurance/quality control and regulatory table 1 of this document.

TABLE 1.—WORKSHOP LOCATIONS AND SCHEDULES

Workshop Address Dates and Local Times

Hyatt Regency Bethesda, 1 Bethesda Metro Center, Bethesda, MD 20814 November 1 and 2, 2007, from 9 a.m. to 5 p.m. each day

The Gresham Hotels, 23 Upper O’Connell St., Dublin 1, Ireland December 10 and 11, 2007, from 9 a.m. to 5 p.m. each day

Peking University, Beijing, China 100871 April 21 and 22, 2008, from 9 a.m. to 5 p.m. each day

Grand Hyatt Shanghai, Jin Mao Tower, 88 Century Blvd., Pudong, Shanghai, April 24 and 25, 2008, from 9 a.m. to 5 p.m. each day China 200121

C. How Can I Participate? D. Is There a Registration Fee for This Bethesda, MD and Dublin, Ireland You can participate in person. Workshop? workshops are listed in table 2 of this Anyone interested in the GMP Yes, a registration fee is required for document. The registration fee for both workshops can register through the this workshop. The registration fee China locations (Beijing and Shanghai) contact person (see FOR FURTHER includes workshop reference materials is $550 with no discounts. All fees are INFORMATION CONTACT). and meals. Registration fees for the given in U.S. dollars.

TABLE 2.—REGISTRATION FEES FOR THE BETHESDA, MD AND DUBLIN, IRELAND WORKSHOPS

Government Employee Date of Registration PDA Member Nonmember or Health Authority Academic Student

Through October 1, 2007 $1,295 $1,695 $350 $3501 $150

After October 1, 2007 $1,495 $1,895 $405 $4051 $180 1 Must be PDA member to receive this rate.

E. How Can I Get Additional FDA and industry will provide a Paperwork Reduction Act of 1995 (44 Information? regulatory and practical perspective on U.S.C. Chapter 35). To request a copy of the current relevant critical topics. the clearance requests submitted to The notice of participation form, OMB for review, call the HRSA Reports information about the workshops, and Dated: September 14, 2007. Clearance Office on (301) 443–1129. other related documents are available Jeffrey Shuren, from the contact person (see FOR Assistant Commissioner for Policy. The following request has been FURTHER INFORMATION CONTACT) and on [FR Doc. E7–18556 Filed 9–19–07; 8:45 am] submitted to the Office of Management and Budget for review under the the Internet at http://www.fda.gov/cder/ BILLING CODE 4160–01–S workshop.htm. Paperwork Reduction Act of 1995: II. Background Information Proposed Project: Children’s Hospital DEPARTMENT OF HEALTH AND Graduate Medical Education (CHGME) A. Why Is FDA Cosponsoring These HUMAN SERVICES Payment Workshops? Health Resources and Services Program Annual Report: NEW FDA is cosponsoring these 2-day Administration workshops to provide information and The CHGME Payment Program was training opportunities for industry as Agency Information Collection enacted by Public Law 106–129 to well as CGMP compliance officials. Activities: Submission for OMB provide Federal support for graduate medical education (GME) to B. What Will Be Covered? Review; Comment Request freestanding children’s hospitals, The workshops will provide Periodically, the Health Resources similar to Medicare GME support information on specific topics designed and Services Administration (HRSA) received by other non-children’s to educate and guide participants on publishes abstracts of information hospitals. The legislation mandates that methodologies and implementation of collection requests under review by the eligible children’s hospitals will receive CGMP as applied to quality drug Office of Management and Budget payments for both direct and indirect manufacturing. Presentations by both (OMB), in compliance with the medical education. Direct payments are

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designed to offset the expenses medical certification boards; (2) the those who are (1) in full-time equivalent associated with operating approved number of training positions for resident training positions in any graduate medical residency training residents, the number of such positions training program sponsored by the programs and indirect payments are recruited to fill, and the number of hospital; or (2) in a training program designed to compensate hospitals for positions filled; (3) the types of training sponsored by an entity other than the expenses associated with the treatment that the hospital provided for residents hospital who spend more than 75 of more severely ill patients and the related to the health care needs of percent of their time training at the additional costs relating to teaching difference populations such as children hospital. residents in such programs. who are underserved for reasons of The annual report data collection The CHGME Payment Program was family income or geographic location, instruments consist of Excel workbooks reauthorized for a period of five years in including rural and urban areas; (4) with several pages (worksheets) each. October 2006 by Public Law 109–307. changes in residency training the These data collection instruments for The reauthorizing legislation requires hospital made during an academic year, the annual report were pre-tested by that children’s hospitals participating including changes in curricula, training nine participating CHGME Payment and receiving funds from the CHGME experiences, and types of training Program hospitals. Each hospital Payment Program provide information programs, and benefits that have provided an estimate of the number of about their residency training programs resulted from such changes and changes hours required to complete each part of in an annual report that will be an for purposed of training residents in the the annual report. Following the pre- addendum to the hospitals’ annual measurement and improvement and the test, the data collection instruments applications for funds. Specifically, data quality and safety of patient care; and were significantly reduced by collapsing are required to be collected on: (1) The (5) the numbers of residents certain categories, shifting several types of training programs that the (disaggregated by specialty and questions from the individual GME hospital provided for residents such as subspecialty) who completed training in training program level to the hospital general pediatrics, internal medicine/ the academic year and provide care level instrument, and by omitting pediatrics, and pediatric subspecialties within the borders of the service area of several questions. As a result, the including both American Board of the hospital or within the borders of the estimated burden to each respondent Pediatrics certified medical State in which the children’s hospital is was significantly reduced. subspecialties and non-medical located. For purposes of the annual The estimated annual burden is as subspecialties approved by other report data collection, ‘‘residents’’ are follows:

Responses Form name Number of per Total number Hours per Total burden respondents respondent of responses response hours

Screening Instrument ...... 57 1 57 10.0 570.0 Annual Report, Hospital and Program-Level Information .... 57 1 57 74.8 4263.6

Total ...... 57 ...... 57 84.8 4833.6

Written comments and ACTION: Final Agency Guidance and primarily low-income and minorities, recommendations concerning the Response to Public Comments. and deliver comprehensive, culturally proposed information collection should competent, quality primary health care SUMMARY: be sent within 30 days of this notice to The Health Resources and services to patients regardless of their Services Administration (HRSA) is the desk officer for HRSA, either by e- ability to pay. Charges for health care publishing a final Agency Guidance mail to [email protected] services are set according to income. (‘‘Policy Information Notice’’ (PIN) or by fax to 202–395–6974. Please direct On March 15, 2007, HRSA made the 2007–16) to describe and clarify the draft PIN, ‘‘Federal Tort Claims Act all correspondence to the ‘‘attention of circumstances under which Federal Tort the desk officer for HRSA.’’ Coverage for Health Center Program Claims Act (FTCA)—deemed Health Grantees Responding to Emergencies,’’ Dated: September 14, 2007. Center Program grantees are covered available for public comment on Alexandra Huttinger, under the FTCA as they respond to HRSA’s Web site. Comments were due Acting Director, Division of Policy Review emergencies. The PIN, ‘‘Federal Tort to HRSA by May 31, 2007. and Coordination. Claims Act Coverage for Health Center Comments were received from 14 [FR Doc. E7–18561 Filed 9–19–07; 8:45 am] Program Grantees Responding to organizations and/or individuals. After Emergencies,’’ and the Agency’s BILLING CODE 4165–15–P review and careful consideration of all ‘‘Response to Public Comments’’ are comments received, HRSA has amended available on the Internet at http:// the PIN to incorporate certain DEPARTMENT OF HEALTH AND bphc.hrsa.gov/policy/pin0716. recommendations from the public. The HUMAN SERVICES DATES: The effective date of this final final PIN reflects these changes. Agency guidance is August 22, 2007. In addition to making the final PIN Health Resources and Services BACKGROUND: HRSA administers the available on HRSA’s Web site, HRSA is Administration Health Center Program, which supports also posting the Agency’s ‘‘Response to more than 3,800 health care delivery Public Comments.’’ The purpose of that Notice of Availability of Final Policy sites, including community health document is to summarize the major Guidance centers, migrant health centers, health comments received and describe the care for the homeless centers, and Agency’s response, including any AGENCY: Health Resources and Services public housing primary care centers. corresponding changes made to the PIN. Administration, HHS. Health centers serve clients that are Where comments did not result in a

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revision to the PIN, explanations are Health centers serve clients that are DEPARTMENT OF HEALTH AND provided. primarily low-income and minorities, HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: For and deliver comprehensive, culturally Substance Abuse and Mental Health questions regarding this notice, please competent, quality primary health care Services Administration contact the Office of Policy and Program services to patients regardless of their ability to pay. Charges for health care Development, Bureau of Primary Health Agency Information Collection Care, HRSA, at 301–594–4300. services are set according to income. Activities: Submission for OMB Dated: September 14, 2007. On February 27, 2007, HRSA made Review; Comment Request Elizabeth M. Duke, the draft PIN available for public Periodically, the Substance Abuse and Administrator. comment on HRSA’s Web site. The purpose of the PIN was to provide Mental Health Services Administration [FR Doc. E7–18562 Filed 9–19–07; 8:45 am] (SAMHSA) will publish a summary of BILLING CODE 4165–15–P guidance on emergency management expectations for health centers to assist information collection requests under OMB review, in compliance with the them in planning and preparing for Paperwork Reduction Act (44 U.S.C. future emergencies. Comments were due DEPARTMENT OF HEALTH AND Chapter 35). To request a copy of these HUMAN SERVICES to HRSA by April 13, 2007. documents, call the SAMHSA Reports Comments were received from 31 Health Resources and Services Clearance Officer on (240) 276–1243. organizations and/or individuals. After Administration Project: Independent Evaluation of the review and careful consideration of all Substance Abuse Prevention and comments received, HRSA amended the Notice of Availability of Final Policy Treatment Block Grant Program—NEW Guidance PIN to incorporate certain recommendations from the public. The The Substance Abuse and Mental AGENCY: Health Resources and Services final PIN reflects these changes. Health Services Administration Administration, HHS. (SAMHSA), Center for Substance Abuse In addition to making the final PIN ACTION: Final Agency Guidance and Treatment (CSAT), Division of State and available on HRSA’s Web site, HRSA is Response to Public Comments. Community Assistance administers the also posting the Agency’s ‘‘Response to Substance Abuse Prevention and DATES: The effective date of this final Public Comments.’’ The purpose of the Treatment Block Grant (SAPT BG) in Agency guidance is August 22, 2007. document is to summarize the major collaboration with the Center for SUMMARY: The Health Resources and comments received and describe the Substance Abuse Prevention (CSAP), Services Administration (HRSA) is Agency’s response, including any Division of State Programs. The publishing a final Agency Guidance corresponding changes made to the PIN. Substance Abuse Prevention and (‘‘Policy Information Notice’’ (PIN) Where comments did not result in a Treatment Block Grant is funded by 2007–15) to provide guidance on revision to the PIN, explanations are Congress to provide monies to States, emergency management expectations for provided. Territories, and one Native American health centers to assist them in planning Tribe for the purpose of planning, and preparing for future emergencies FOR FURTHER INFORMATION CONTACT: carrying out, and evaluating activities to through the development and Please contact the Office of Policy and prevent and treat substance abuse and maintenance of an effective and Program Development at (301) 594–4300 other allowable activities. The SAPT BG appropriate emergency management for any questions regarding this PIN. constitutes approximately 40 percent of strategy. The PIN, ‘‘Health Center Dated: September 14, 2007. all States budgets for substance abuse Emergency Management Program Elizabeth M. Duke, prevention and treatment services and Expectations,’’ and the Agency’s activities, and is the primary Federal Administrator. ‘‘Response to Public Comments’’ are source of funding. States have flexibility available on the Internet at http:// [FR Doc. E7–18560 Filed 9–19–07; 8:45 am] in determining how funds should be bphc.hrsa.gov/policy/pin0715. BILLING CODE 4165–15–P allocated, but there are specific set-aside Background: HRSA administers the and maintenance of effort requirements Health Center Program, which supports that must be met in order to receive more than 3,800 health care delivery funding. These requirements, sites, including community health introduced by both the ADAMHA centers, migrant health centers, health Reorganization Act of 1992 and the care for the homeless centers, and Children’s Health Act of 2000, are listed public housing primary care centers. below:

TABLE 1.—SAPT BG SET-ASIDE PROVISIONS a

Category Set-aside provision

Prevention and treatment activities regarding al- Not less than 35 percent of SAPT BG funding*. cohol. Prevention and treatment activities regarding Not less than 35 percent of SAPT BG funding*. other drugs. Primary prevention programs ...... Not less than 20 percent of SAPT BG funding. Pregnant women and women with dependent Not less than amount equal to expenditure in FY 1994. children. Tuberculosis services ...... No set amount but services must be provided to receive SAPT BG funds. HIV services b ...... No more than 5 percent increase over State allotment for HIV services in FY 1991.

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TABLE 1.—SAPT BG SET-ASIDE PROVISIONS a—Continued

Category Set-aside provision

Prohibition of sale of tobacco to individuals State must enforce law against sale of tobacco to underage individuals to receive SAPT BG under age of 18 (Synar amendment). funds—noncompliance leads to a 10 percent reduction in funds the first applicable fiscal year; 20 percent, the second year; 30 percent, the third year; and 40 percent, the fourth year. Maintenance of effort (MOE) for State expendi- State will maintain funding at no less than the average level of expenditures for the 2 years tures. preceding the fiscal year for which the State is applying. Administrative expenses ...... Limited to 5 percent of SAPT BG funding. a These set-asides shown in this table were included in the 1992 SAPT BG authorizing legislation 42 U.S.C. 300x–21 to 42 U.S.C. 300x–62). In the Children’s Health Act of 2000 (Pub. L. 106–310) Sec. 3303(a)(1)), however, the set-asides marked with asterisks were removed. b For designated States whose rate of AIDS cases is 10 or more per 100,000 individuals as confirmed by the Centers for Disease Control and Prevention.

In addition to the set-asides, the SAPT which must be met by States in order to BG Program has identified 17 goals receive this Federal funding:

TABLE 2.—FEDERAL GOALS FOR THE SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT

GOAL #1: Continuum of substance abuse treat- The State shall expend block grant funds to maintain a continuum of substance abuse treat- ment services. ment services that meet these needs for the services identified by the state (see 42 U.S.C. 300x–21(b) and 45 CFR 96.122(f)(g)). GOAL #2: Spending on primary prevention pro- The State agrees to spend not less than 20 percent on primary prevention programs for indi- grams. viduals who do not require treatment for substance abuse, specifying the activities proposed for each of the six strategies (see 42 U.S.C. 300x–22(b)(1) and 45 CFR 96.124(b)(1)). GOAL #3: Spending on services for pregnant The State agrees to expend not less than an amount equal to the amount expended by the women and children. State for FY 1994 to establish new programs or expand the capacity of existing programs to make available treatment services designed for pregnant women and children with depend- ent children; and, directly or through arrangements with other public or nonprofit entities, to make available prenatal care to women receiving such treatment services, and, while the women are receiving services, child care (see 42 U.S.C. 300x–22(c)(1) and 45 CFR 96.124(c)(e)). GOAL #4: Treatment for intravenous drug abus- The State agrees to provide treatment to intravenous drug abusers that fulfills the 90 percent ers. capacity reporting, 14–120 day performance requirement, interim services, outreach activi- ties and monitoring requirements (see 42 U.S.C. 300x–23 and 45 CFR 96.126). GOAL #5: Tuberculosis services for people in The State agrees, directly or through arrangements with other public or nonprofit private enti- substance abuse treatment. ties, to routinely make available tuberculosis services to each individual receiving treatment for substance abuse and to monitor such service delivery (see 42 U.S.C. 300x–24 and 45 CFR 96.127). GOAL #6: Early intervention services for HIV for Designated States agree to provide treatment for persons with substance abuse problems with people in substance abuse treatment. an emphasis on making available within existing programs early intervention services for HIV in areas of the state that have the greatest need for such services and to monitor such service delivery (see 42 U.S.C. 300x–24(b) and 45 CFR 96.128). GOAL #7: Group homes for recovering sub- Designated States agree to provide for and encourage the development of group homes for stance abusers. recovering substance abusers through the operation of a revolving loan fund (see 42 U.S.C. 300x–25 and 45 CFR 96.129). GOAL #8: State efforts to reduce the availability The State agrees to continue to have in effect a State law that makes it unlawful for any man- of tobacco products. ufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18; and, to enforce such laws in a manner than can reason- ably be expected to reduce the extent to which tobacco products are available to individuals under age 18 (see 42 U.S.C. 300x–26 and 45 CFR 96.130). GOAL #9: Preferential admission of pregnant The State agrees to ensure that each pregnant woman be given preference in admission to women to substance abuse treatment. treatment facilities; and, when the facility has insufficient capacity, to ensure that the preg- nant woman be referred to the State, which will refer the woman to a facility that does have the capacity to admit the woman, or if no such facility has the capacity to admit the woman, will make available interim services within 48 hours (see 42 U.S.C. 300x–27 and 45 CFR 96.131). GOAL #10: Improved process for referring indi- The State agrees to improve the process in the State for referring individuals to the treatment viduals to substance abuse treatment. modality that is most appropriate for the individual (see 42 U.S.C. 300x–28 and 45 CFR 96.132(a)). GOAL #11: Continuing education for employees The State agrees to provide continuing education for the employees of facilities which provide at substance abuse prevention and/or treat- prevention activities or treatment services (or both) (see 42 U.S.C. 300x–28(b) and 45 CFR ment facilities. 96.132(b)). GOAL #12: Coordination of services ...... The State agrees to coordinate prevention activities and treatment services with the provision of other appropriate services (see 42 U.S.C. 300x–28(c) and 45 CFR 96.132(c)). GOAL #13: Needs assessment by State and lo- The State agrees to submit an assessment of the need for both treatment and prevention in cality. the State for authorized activities, both by locality and by the State in general (see 42 U.S.C. 300x–29 and 45 CFR 96.133). GOAL #14: Ensuring that needles and syringes The State agrees to ensure that no program funded through the block grant will use funds to are not provided for illegal drug use. provide individuals with hypodermic needles or syringes so that such individuals may use il- legal drugs (see 42 U.S.C. 300x–31(a)(1)(F) and 45 CFR 96.135(a)(6)).

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TABLE 2.—FEDERAL GOALS FOR THE SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT—Continued GOAL #15: Improving the quality and appro- The State agrees to assess and improve, through independent peer review, the quality and priateness of treatment services. appropriateness of treatment services delivered by provider that receive funds from the block grant (see 42 U.S.C. 300x–53(a) and 45 CFR 96.136). GOAL #16: Protecting patient records from in- The State agrees to ensure that the State has in effect a system to protect patient records appropriate disclosure. from inappropriate disclosure (see 42 U.S.C. 300x–53(b), 45 CFR 6.132(e), and 42 CFR part 2). GOAL #17: Compliance with 42 CFR part 54 The State agrees to ensure that the State has in effect a system to comply with 42 CFR part Charitable Choice Provisions and Regulations. 54 (see 42 CFR 54.8(c)(4) and 54.8(b)) Charitable Choice Provisions and Regulations). Source: Performance Partnership Grant Branch, Division of State and Community Assistance, Center for Substance Abuse Treatment, Sub- stance Abuse and Mental Health Services Administration, ‘‘Uniform Application, FY 2007, Substance Abuse Prevention and Treatment Block Grant (42 U.S.C. 300x–21 through 300x–64),’’ Rockville, MD, 2004.

The FY 2003 Office of Management examine Federal and State performance evaluation framework and logic model and Budget (OMB) Program Assessment with regard to the SAPT BG and its will be examined in the independent Rating Tool (PART) assessment of the identified goals. This approach evaluation. These selected NOMs items SAPT BG Program rated the program as emphasizes a qualitative and include: ‘‘Ineffective.’’ The SAPT BG received quantitative examination of both the • Increase in number of persons high scores on three of four PART areas SAPT BG process (e.g., activities and reporting a reduction in 30-day drug/ rated, including Program Purpose and outputs in the logic model) and system- alcohol use Design, Strategic Planning, and Program level outcomes whereby Federal and • Increase in number of persons Management. However, the scores could State stakeholder perspectives on the employed or in school have been even higher in these areas if SAPT BG, as captured through semi- • Reduction in number of drug or data were available to document that the structured interviews and surveys, are alcohol-related arrests resources were reaching the intended corroborated and compared to the • Increase in number of persons in beneficiaries or the program had considerable amount of already- stable housing situations (reduction in ambitious targets and long-term collected source documents and data homelessness) measures. In the fourth area, Program provided by States, CSAT, and CSAP • Increase in access to services Results/Accountability, where a low (e.g., Web Block Grant Application measured by unduplicated counts of rating was achieved, it was found that System (BGAS), Treatment Episode Data persons served and numbers served ‘‘no independent evaluation of the Set (TEDS), National Survey on Drug compared to those in need program has been completed’’ to Use and Health (NSDUH), the Minimum • Increase in number of persons establish that the SAPT BG Program is Data Set (MDS), Technical Review receiving evidence-based services. effective and fulfilling its legislative Reports, State Prevention and Synar In addition, the evaluators will mandates. System Reports). In direct response to this OMB attempt to collect information on finding, a contract was developed and The purpose of the evaluation is to system-wide client perception of care. awarded in FY 2003 to conduct an determine the extent to which States Statistical tests for association between Evaluability Assessment (EA) to and the Federal Government are outcome measures and a number of determine the feasibility of conducting implementing the SAPT BG according independent variables will be an independent evaluation of the SAPT to the authorizing legislation and conducted. Examples of independent BG Program, and subsequently, to fund implementing regulations. The variables include, but are not limited to, such an evaluation effort. EA is a evaluation will cover the following level of funding, level of the Single State recognized program evaluation domains: The State SAPT BG planning Agency (SSA) for substance abuse methodology which involves process, Federal review of SAPT BG services within State government, collaboration with multiple applications including annual reports, degree of SSA partnership with other stakeholders and development of a progress reports and intended use plans, State agencies and community program logic model used to plan Federal technical assistance, State SAPT organizations, and amount of State- formal evaluations of large and/or BG implementation, Federal oversight funded support available for research complex programs, such as the SAPT and management, State SAPT BG and training activities. BG Program. The findings of the EA reporting, and State-level outcomes. The In addition to information about the were used as a foundation in the results of this evaluation will not only selected NOMs domains, the evaluation development and awarding of a multi- document the effectiveness of the SAPT will also examine systemic measures year contract in FY 2004 to conduct an BG Program in supporting the Substance related to infrastructure. Infrastructure independent, comprehensive evaluation Abuse Prevention and Treatment refers to the resources, systems, and of the SAPT BG Program. system, they will also help guide CSAT policies that support the nation’s public As noted in the OMB PART and CSAP and the States to improve the substance abuse prevention and Assessment, the legislative intent of the methods by which they implement the treatment system, and is a potential SAPT BG is to provide funding to States SAPT BG, including the capacity to contributor to significant State by formula to plan, carry out, and collect, analyze, and interpret the behavioral health system outcomes. evaluate activities to prevent and treat National Outcome Measures (NOMs). As Examples of infrastructure include staff substance abuse. Therefore, the a separate, parallel SAMHSA initiative, training, policy changes, and service evaluation is designed to examine the the NOMs project began after the SAPT availability. system-level activities, outputs, and BG Evaluation contract inception and Because this is the first-ever outcomes associated with the program was not used in the SAPT BG EA or the comprehensive evaluation of the SAPT in relation to its goals. development of the evaluation BG Program, the data collection In this evaluation, a multi-method framework and logic model. However, activities are more extensive (and time evaluation approach is being used to selected NOMs items that relate to the intensive) than would be expected of a

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program that has been regularly includes 99 questions (again, mostly formal reviewers for the SAPT BG: evaluated. These data will serve as a open-ended), and should take, on Technical Reviewers and State baseline for future evaluations. The two average, 3 hours to complete. Both the Prevention and Synar System primary data collection strategies will Federal staff interviews and the State Reviewers. The web-based surveys are include open-ended interviews and staff interviews will be conducted as in- designed so that each stakeholder group web-based surveys. Interviews will be person interviews. While the Federal receives survey questions designed to conducted with Federal staff involved staff will each be interviewed capture their specific knowledge of and in the administration of the SAPT BG individually, a single group State staff experience with the SAPT BG. The and State staff from all States and interview will be conducted for all Technical Reviewer survey contains 47 Territories involved in their State’s relevant State staff. The SSA Directors questions and the State Prevention and implementation of the SAPT BG will be asked to select those State staff Synar System Reviewer survey has 27 Program. Two web-based surveys will who they believe are most questions. Each survey should take be administered to all individuals who knowledgeable about the SAPT BG for approximately 1 hour or less to formally participate in monitoring the participation in the interviews. It is complete. Reviewers will submit their SAPT BG as part of the Technical anticipated that, at a minimum, the responses to the survey online over a Review or State Prevention and Synar State Planner, the State Data Analyst, 3-week period. System Review Teams. the State Prevention Lead, the State The interview protocol for Federal Treatment Lead, one additional State Table 3 summarizes the estimated staff includes 80 questions (mostly staff member, and the State SSA annual total burden hours for the in- open-ended), and, on average, should Director will participate. person and web-based surveys for the take 90 minutes to complete. The The two web-based surveys will be Federal and State staff stakeholders and interview protocol for the State staff distributed to the two current sets of Technical Reviewers, Synar Reviewers.

TABLE 3.—ESTIMATED REPORTING BURDEN OF INTERVIEWS AND WEB-BASED SURVEYS

Average hours Respondents Number of per interview/ Estimated total respondents survey burden (hours)

In-person Interviews: State Substance Abuse Prevention and Treatment Agency Commissioner ...... 60 3 180 State Planners ...... 60 3 180 State Data Analysts ...... 60 3 180 State Prevention Lead ...... 60 3 180 State Treatment Lead ...... 60 3 180 Additional State Staff ...... 60 3 180 Federal SAPT Block Grant Staff ...... 35 1 .5 52 .5

Subtotal ...... 395 1,132

Web-based Interviews: Technical Reviewers ...... 15 1 15 State Prevention and Synar System Reviewers ...... 30 1 30

Subtotal ...... 45 ...... 45

Total ...... 440 ...... 1,177

This Federal Register Notice is submit comments by fax to: 202–395– DEPARTMENT OF HOMELAND focused on the interviews and surveys 6974. SECURITY that will be administered to the SAPT Dated: September 12, 2007. BG stakeholders as those methods of Transportation Security Administration data collection require OMB approval. It Elaine Parry, is anticipated that in future independent Acting Director, Office of Program Services. [Docket No. TSA–2006–24191; USCG–2007– evaluations of the SAPT BG Program [FR Doc. E7–18555 Filed 9–19–07; 8:45 am] 27415] focus will be given to the NOMs and BILLING CODE 4162–20–P Transportation Worker Identity their implications for program Credential (TWIC) Biometric Reader performance and goals. Specification and TWIC Contactless Written comments and Smart Card Application recommendations concerning the proposed information collection should AGENCY: Transportation Security be sent by October 22, 2007 to: Administration; United States Coast SAMHSA Desk Officer, Human Guard; DHS. Resources and Housing Branch, Office ACTION: Notice of availability. of Management and Budget, New Executive Office Building, Room 10235, SUMMARY: The Department of Homeland Washington, DC 20503; due to potential Security, through the U.S. Coast Guard delays in OMB’s receipt and processing (Coast Guard) and the Transportation of mail sent through the U.S. Postal Security Administration (TSA), Service, respondents are encouraged to announces the availability of the

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working specification for Transportation (2) Accessing the Government authentication procedures) Worker Identification Credential (TWIC) Printing Office’s Web page at http:// requirements; durability requirements; biometric readers and the TWIC www.gpoaccess.gov/fr/index.html and credential management procedures, contactless smart card application. This (Notice only); or including key management. We specification is based on (3) Visiting TSA’s Security recommended that the biometric recommendations to the Coast Guard Regulations Web page at http:// credentialing experts develop and TSA from the National Maritime www.tsa.gov and accessing the link for technology specifications, including a Security Advisory Committee (NMSAC); ‘‘Research Center’’ at the top of the page. smart card, reader, and keying comments from the public following In addition, copies are available by specifications. publication of the NMSAC writing or calling the individual in the In the course of our discussions with recommendations and request for FOR FURTHER INFORMATION CONTACT NMSAC, members of the committee comment; and, the government’s review section. Make sure to identify the docket stated that they did not wish to of the NMSAC recommendations and number of this action. recommend a specification that included encryption of the biometric comments received. The working I. Background specification is available to review at and corresponding processes to decrypt www.tsa.gov/twic and at http:// The National Maritime Security the biometric when the card engages the dms.dot.gov in docket USCG–2007– Advisory Council (NMSAC) was created reader. Many of the NMSAC members 27415. pursuant to the Federal Advisory asserted that encryption was not Committee Act, 5 U.S.C., App. 2 (FACA) necessary because the biometric—a DATES: The reader specifications and in 2003. The membership of NMSAC, fingerprint minutiae template, rather card application are available which includes 21 voting members, was than an actual fingerprint—should not September 20, 2007. selected to represent a broad range of require the added protection that FOR FURTHER INFORMATION CONTACT: John viewpoints regarding maritime security encryption provides. Also, members of Schwartz, Office of Transportation challenges and to advise the Secretary of NMSAC did not want to take on the Threat Assessment and Credentialing Homeland Security through the additional responsibility of key (TSA–19), Transportation Worker Commandant of the Coast Guard of management, which would be necessary Identification Credential Program relevant maritime security issues. if the recommended specification Transportation Security Administration, At the NMSAC meeting of November included encryption. However, TSA and 601 South 12th Street, Arlington, VA 14, 2006, the Coast Guard and TSA Coast Guard disagreed with NMSAC’s 22202–4220; telephone (571) 227–2177; asked NMSAC to provide advice on a suggestion that the fingerprint template facsimile (703) 603–0409; e-mail contactless biometric smart card does not need to be encrypted and [email protected]. application and reader specification for therefore asked NMSAC to provide one TWIC by February 28, 2007, taking into specification with encryption of the Reviewing Comments and the TWIC account expertise from the biometric biometric and a corresponding process Working Technology Specification in credentialing industry and maritime/ to decrypt the biometric when the card the Docket TWIC industry stakeholders. The engages the reader. The formal request Please be aware that anyone is able to specification is necessary for biometric from the TWIC program to NMSAC is search the electronic form of all readers and the TWICs that will be available at the following URL: http:// comments received into any of our issued to individuals in the initial homeport.uscg.mil, and in the docket for dockets by the name of the individual rollout of the TWIC program, beginning this notice. submitting the comment (or signing the in the fall of 2007, and that will be used On March 1, 2007, the Coast Guard received NMSAC’s report, entitled comment, if submitted on behalf of an in pilot programs required by the ‘‘Recommendations on Developing a association, business, labor union, etc.). Security and Accountability for Every 1 Contactless Biometric Specification for You may review the applicable Privacy Port Act of 2006 (SAFE Port Act). the TWIC.’’ The report included two Act Statement published in the Federal TSA and Coast Guard provided specifications. The first recommended Register on April 11, 2000 (65 FR NMSAC the following baseline specification, preferred by NMSAC for 19477), or you may visit http:// requirements for the specification: the reasons discussed in the paragraph dms.dot.gov. 1. Be non-proprietary; 2. Incorporate appropriate security above, does not provide for encryption You may review the comments in the and privacy controls; of the TWIC cardholder’s biometric public docket by visiting the Dockets 3. Be interoperable with FIPS 201–1 fingerprint minutiae template. Without Office between 9 a.m. and 5 p.m., credential specifications; encryption, the template is transmitted Monday through Friday, except Federal 4. Be capable of serving as a platform in the clear and could be read by a third holidays. The Dockets Office is located for future capabilities; party whenever the card is energized by in the West Building Ground Floor, 5. Be capable of supporting maritime a contactless reader. Therefore, there is Room W12–140, at the Department of operations; and a risk that the template on the TWIC Transportation address, previously 6. Be suitable for manufacturing. could be read without the knowledge or provided under ADDRESSES. Also, you TSA and Coast Guard recommended overt action of the cardholder. may review public dockets on the that the task be addressed by dividing NMSAC’s second specification Internet at http://dms.dot.gov. responsibilities to construct operational includes encryption of the biometric Availability of Document maritime requirements and technology fingerprint minutiae template, which specifications. We recommended that will protect the template from being You can get an electronic copy of this members of the maritime industry decrypted unless information on the Notice and the actual working develop operational maritime card’s magnetic stripe or contact specifications using the Internet by— requirements and address credential integrated circuit chip (ICC), is also (1) Searching the Department of authentication (e.g. authentication time provided to the reader. The information Transportation’s electronic Docket and process, and alternate on the card’s magnetic strip (or ICC) is Management System (DMS) Web page needed to decrypt the template, which (http://dms.dot.gov/search); 1 Pub. L. 109–347; October 13, 2006. is obtained contactlessly from the card.

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This method of encryption protects the frame, and we greatly appreciate requiring the use of both PINs and template from being read even if it is NMSAC’s efforts in this important biometrics at certain Maritime Security obtained covertly since the information security endeavor. In the following (MARSEC) levels. Commenters also on the card’s magnetic stripe (or ICC) section, we summarize all comments mentioned that the upcoming TWIC cannot be obtained without physical received. pilot program that TSA and Coast Guard possession of the card. If a TWIC is are implementing to test card and reader physically obtained by someone other II. Summary of Comments interaction will be helpful in identifying than the rightful owner, the information Question 1—Additional Security impacts on facility and vessel necessary to obtain and decrypt the Features operations. template would be available to them. Note that each TWIC will contain Commenters generally agreed that the Question 4—Impacts on Existing three magnetic stripes and the first is additional security feature mentioned, a Physical Access Control Systems reserved exclusively for TSA’s use to PIN, was not a good idea for general use Commenters generally agreed that the store encryption information. Owner/ due to operational concerns. Others TWIC program will have a significant operators may use the remaining two stated that a PIN should be considered impact on existing PACS if the two are magnetic stripes for information that only if it could be used in a way that integrated and will be duplicative if facilitates the use of local access control does not adversely impact maritime they are not. They cited the need for systems so long as doing so does not operations. Many commenters stated replacing or enhancing existing systems; interfere with the information encoded that TWIC holders would likely forget additional trenching and related by TSA on the first magnetic stripe that their PINs, which would become construction activities; and, installing or allows contactless operation of the burdensome to TWIC users and upgrading electrical power supplies and TWIC. Technical specifications for the maritime operations. As for PIN length, wiring to readers as examples of the magnetic stripe and areas reserved for the few who commented prefer a 4-digit impacts TWIC will have on existing TSA use are contained in the TWIC PIN over a longer PIN. PACS. Some commenters mentioned contactless card and reader working Only one commenter discussed an that the use of TPK would impact legacy specification. alternative security feature—the use of a PACS by requiring the modification or In March 2007, the Coast Guard smart card holder that protects replacement of existing readers to published a Notice of Availability of the information stored on the card’s include a magnetic stripe reading NMSAC Recommendations and integrated circuit chip until the holder capability. Some commenters expressed requested comments from all interested is activated by the card holder’s live concern that multiple credentials may parties. (72 FR 12626, March 16, 2007.) biometric. At least one commenter be required of certain workers at certain In addition to requesting general suggested that to help deter fraudulent locations and that multiple credentials comments, Coast Guard asked the use of the TWIC, fingerprint scanners would have to be processed to allow public to respond to specific questions, associated with card readers should be entry. Several commenters asserted that including: (1) Whether the use of a able to confirm that the fingerprint the cost of integration should be Personal Identification Number (PIN) is being presented is that of a live person supported by Federal grant funding. justified to further minimize the chance rather than an artificial replica of a One commenter suggested that TWIC that a fingerprint template from a lost or fingerprint or fingerprint template. This PACS requirements should have a long stolen credential could be obtained by capability is called ‘‘liveness’’ detection. phase-in period to allow facilities to use an unauthorized individual; (2) what, if Question 2—Privacy Concerns legacy equipment through the end of its any, privacy concerns exist if the useful life. fingerprint template is obtained by an Most commenters from the maritime unauthorized individual; (3) how the industry stated that maintaining the Question 5—Alternative Designs recommended specifications impact privacy of the information stored on the Commenters mentioned that any maritime security and operations; (4) card is important, but they do not alternative designs should be evaluated how the recommended specifications believe additional measures are in the context of the maritime operating impact existing physical access control necessary to protect the privacy of requirements established by the NMSAC systems (PACS); (5) whether TSA and biometric fingerprint templates. working group. Several commenters Coast Guard should consider alternative However, commenters from the suggested that the short time period designs; (6) how the recommended technology industry generally asserted allotted for development of the specifications impact product, system, that biometric fingerprint templates technical specification may have and operational costs; (7) how quickly should be protected, and that the TWIC prevented alternative designs from the recommended specifications could Privacy Key (TPK) scheme provided in emerging. However, a technology be incorporated into the design and NMSAC’s alternative recommended industry commenter stated that manufacture of access control specification is sufficient to protect the alternatives were considered and equipment; and (8) whether there template. rejected by the technology team during should be a qualified products list (QPL) Question 3—Vessel and Facility their deliberations. The commenter or equivalent regime. Security Operations stated that the following alternative Over thirty separate entities submitted designs were considered and rejected: comments to these questions. The A number of maritime commenters majority of commenters represented the stated that use of a PIN and TPK card 1. Shared Symmetric Keys maritime industry, but several swipe scheme, and, encryption of the Key management is operationally technology companies and trade fingerprint biometric template have the complex and exposure of the key would associations also responded. Generally, potential to adversely impact port and have a negative impact on the entire the commenters praised the work of the facility operations. Specifically, TWIC system. Shared symmetric keys NMSAC TWIC Contactless Specification commenters expressed concern about rely on one secret key to be distributed Workgroup. TSA and Coast Guard agree error rates that might impact gate among all readers and cards to establish that NMSAC delivered excellent throughput, particularly during times of secure communications between card recommendations in a very short time- high-volume access; and, the effect of and reader. Keys must be changed

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regularly, and securely distributed and One commenter requested that the III. Working Specification Selected stored to maintain system security. distance between the card reader and A. Summary of Selection Secure key management would be the card be increased from four to 18 difficult to accomplish due to the inches to allow truck drivers to remain TSA and the Coast Guard have number and dispersion of TWIC readers. in their cabs while their TWICs are read. selected the NMSAC alternate Some commenters reiterated their view recommendation that requires 2. Public Key Infrastructure (PKI) that the specification should not include encryption and use of the TWIC Privacy In a PKI system, secure encryption in any form. Key (TPK) as the working specification for readers that will be used during the communication and authentication are Question 6—Cost Impacts done using public key certificates which pilot programs. If the readers that meet require online communication. The A number of commenters reiterated this working specification perform as fragmented TWIC PACS would lack the their endorsement of NMSAC’s non- planned during the pilot testing, we will real-time network access required of a encryption recommendation to finalize the specification as we complete PKI system. minimize costs. Commenters who the rulemaking that requires the use of operate existing PACS expressed readers. Also, it is important to note that 3. Biometric Match-on-Card (MOC) concern about integrating TWIC into the TWICs that will be issued this fall their operation, particularly if in the initial rollout of the TWIC MOC involves matching a biometric encryption of the biometric is required program will operate as designed when sample against a reference biometric and if wiring upgrades are necessary to engaged in readers that are built to this template stored inside the secure support TWIC readers. Commenters working specification. environment of a smart card. The who do not have PACS now expressed We are choosing to adopt this reference template cannot be read concern about how much it will cost to specification to protect the personally outside of the card, but is only used purchase, install, and maintain TWIC identifiable information (PII) contained internally by the matching process systems. in the TWIC from unintended disclosure inside the smart card. MOC is a while the TWIC is in the possession of relatively new approach within the Question 7—Incorporation of TWIC Into the credential’s rightful owner. Even smart card and biometrics industries Existing Access Control Equipment assuming individuals suffer no real and provides a good level of security Maritime industry commenters injury today if their template is taken or and privacy. This is because the user’s generally deferred this question to the lifted through an unauthorized process, biometric information is protected by technical experts. Technical the template is personal information the smart card and is never released commenters stated that the connected to that individual. Using a from the card. Internal to the smart card, specifications TSA and Coast Guard fingerprint template in lieu of a MOC matches the user’s live biometric choose for the TWIC program will fingerprint image does not necessarily template provided by an external determine the ease of design, prevent the long-term potential for biometric reader with the user’s stored manufacture, and integration. They also unauthorized use of personally reference template. A major advantage stated that knowledge gained through identifying fingerprint information, if to MOC over other approaches is that experience with designs for other PACS intercepted by unauthorized persons. the card never releases personally that share common attributes with Even assuming the fingerprint template identifying information (the biometric TWIC will lessen the time needed to cannot be reverse-engineered to produce template) to the reader. Thus, the create TWIC PACS products. an accurate duplicate fingerprint today, biometric could not be lifted or Conversely, features that are unique to we cannot be certain that such a ‘‘skimmed’’ by an unauthorized TWIC will have to be created, but some capability will not arise in the future. individual. Also, under the MOC commenters believe TWIC-unique With the use of the TPK model, security process, the need for reader features can be accommodated through and privacy protection are provided authentication and associated reader software or firmware (i.e., computer without the burden that other key management is minimized because programming instructions that are encryption models would place on the reader only stores public keys that stored in a read-only memory unit PACS owners and operators. do not need to be protected from rather than being implemented through TSA and Coast Guard take the disclosure by using a Secure Access software) applications for existing industry’s concerns about adverse Module (SAM) to store secret keys to readers. The commenters estimate that it operational impacts very seriously. identify a particular smart card. With may take from only a few months up to Consequently, as the card and readers MOC, the transmission of the biometric 36 months to integrate TWIC with are envisioned to operate when TWIC is template from the reader to the card is certain PACS designs. fully implemented, use of a PIN will not done using the public key and can only be necessary to release the biometric be decrypted using the private key that Question 8—Quality Products List unless the owner/operator chooses to is stored securely on the smart card. For Process & Creation use contact readers and the contact side all of these reasons, MOC is a very Almost universally, commenters of the credential. In addition, we are in promising technology to pursue. agreed that TSA and Coast Guard the process of finalizing plans for the However, it has not been fully tested in should use a QPL process to help pilot tests required by the SAFE Port a variety of laboratory or field settings stakeholders know what equipment is Act and we are working with experts and currently, there are no approved best for use in the maritime within DHS to establish a very thorough MOC standards. Therefore, we have environment. Many commented that the test plan to evaluate the card-reader determined that it would not be process the U.S. General Services interface under a variety of conditions advisable to implement MOC for the Administration uses should be and assess its impact on operations. upcoming TWIC rollout. We will considered as a starting point for Through the pilot tests, we will continue to follow the development of development of a TWIC QPL. investigate the impacts of requiring MOC and if it matures for operational Commenters also stated that product biometric identity verification on use, we will again consider its use in the testing should include harsh maritime business processes, technology, and maritime environment. conditions. operations on facilities and vessels of

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various size, type, and location. As recommendation of smart card, PACS, B.2. Authentication Methods Used at detailed below, while the government and biometrics industry experts MARSEC Levels: has removed any specific language involved in the NMSAC working group NMSAC recommended that CHUID about MARSEC levels from the process and a thorough review of authentication should be used at specifications, the pilot testing process technology choices and impacts by MARSEC 1 and biometric will be used to evaluate various use case government experts. These experts authentication should be used at scenarios that will influence the leveraged other similar technologies MARSEC 2. Specifying authentication upcoming TWIC reader rulemaking from contactless identification regimes methods for various threat or risk levels process, including TWIC card and in their deliberations. While is outside of the scope of a technical reader use requirements at various implementation of the TWIC program specification for contactless cards and MARSEC levels. should be as timely as possible, we readers, and is more appropriately We understand that the decision to understand that technical addressed separately in the risk implement the TPK model for implementation timelines must management and security requirements contactless biometric identity incorporate engineering and for maritime operators. Therefore, we verification will have impacts on the manufacturing time, field testing, have removed the MARSEC guidance installed base of PACS systems. facility adaptation, and final field relating to use of specific authentication However, the TPK model allows installation. levels at different MARSEC levels from facilities to integrate the model with the working specification. their local PACS in several different We are encouraged by the positive ways. The TPK model allows use of: (1) responses we received regarding the B.3. Biometric Liveness Detection creation of a QPL. However, unlike The magnetic stripe to transfer TPK NMSAC recommended that biometric information by swiping the card through other government smart card programs, liveness detection may be employed in a magnetic strip reader and then TWIC card readers, in most cases, will TWIC readers, making liveness presenting the card to a contactless not be procured by the government. detection optional. Liveness detection is reader to securely transmit the biometric This lessens the ability of the an important means to prevent spoofing template; (2) pre-registration of the government to leverage existing QPL- of a biometric sensor and is generally information on the magnetic stripe into type programs already in existence, something that is strongly the local PACS and then presenting the such as those supporting the Homeland recommended by the reader industry. card to a contactless reader; or (3) pre- Security Presidential Directive Because standards for liveness detection registering the biometric minutiae (HSPD)—12 Personal Identity are currently not available, and there is templates into the local PACS until Verification (PIV) Program. no conformance testing protocol to retrieved upon presentation of the TWIC validate its effectiveness, it is difficult to to a contactless reader. The TPK model B. Technical Changes to the TPK Working Specification specify liveness detection as a also allows several options for handheld mandatory requirement. However, we readers. Handheld reader options TSA and Coast Guard are making have changed the language for liveness include the use of either the contact or some technical modifications to the TPK detection from may to should, to stress contactless portion of the TWIC to working specification recommended by that liveness detection (or attended enable biometric identity verification. NMSAC. We believe these changes are verification) in TWIC readers is a highly We do not wish to implement any necessary to further protect privacy and desirable feature. This change will have alternative designs at this time. security for the TWIC program. There no operational impact on TWIC However, we may add additional are four important changes involving contactless transactions. security features to the card or card verification of the cardholder unique reader with due notice to the industry B.4. Contactless Transmission Speed identifier (CHUID) data, MARSEC level and regard for operational impacts. One operations, biometric liveness detection, The contactless reader performance alternative technology of particular and contactless transmission speed that requirements in the NMSAC interest to the government is match-on- are discussed in detail below. In specification are based upon transaction card (MOC) technology. The TWIC addition, we made minor changes to the completion time. We have determined program and Coast Guard remain in specification that is discussed below. that specific requirements for close contact with the National Institute contactless transmission speed should of Standards and Technology (NIST) in B.1. Signature Verification of CHUID be specified so that the reader will their consideration of MOC technology Data support negotiation of a contactless for various Federal smart card and speed with the card that achieves at personal identification initiatives. The NMSAC specification least 400K bits per second. This will We are mindful that cost is a strong recommends that verification of the minimize transaction timings based on consideration in the operational signature on the CHUID be optional. transmission capabilities of both current implementation of TWIC and we are However, regardless of whether the and future TWIC card versions. This working to minimize costs on the credential is digitally signed, CHUID change will not adversely impact TWIC operational users of TWIC where data can be copied or ‘‘cloned’’ to contactless transactions. possible. Also, we are working closely another card. Signature verification with other DHS components to continue mitigates counterfeited CHUID data C. List of All Changes to the TPK to make available Port Security Grant from being accepted as authentic. For Specification funds to mitigate some of the costs to this reason, verification of the digital Listed below is a complete list of the vessel and facility operators and owners signature on any CHUID unknown to a changes TSA and Coast Guard have of implementing the TWIC program. PACS is mandatory and is included in made to the TPK specification that We have worked closely with the the final specification. Signature NMSAC recommended. The changes of NMSAC working group to understand verification will have minimal interest are discussed in detail above in the impacts of the TWIC program on the performance impact to the contactless Section III.B. maritime sector. Our choice of the TPK transaction and minimal impact on 1. Section 4, TWIC Modes of model is grounded in the specific reader implementation. Operation. Requirement for specific

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authentication modes to be used at 15. Appendix F, Proposed TWIC AID Background specific MARSEC levels has been Structure. TSA RID added, AID The National Customs Automation removed and available authentication structure clarified. Program (NCAP) test concerning the modes have been clarified. D. Future Changes to Specification transmission of automated truck 2. Section 4, TWIC Modes of manifest data for truck carrier accounts TSA and Coast Guard will continue to Operation. Ability to configure specific was announced in a notice published in evaluate and test the working authentication modes depending on a the Federal Register (69 FR 55167) on specification as we implement the TWIC given perimeter security requirement September 13, 2004. That notice stated Pilot Program. We anticipate that, as and to be used at differing MARSEC that the test of the Automated Truck with any testing program, we will levels has been added. Manifest would be conducted in a encounter technical issues that can be 3. Section 4, TWIC Modes of phased approach, with primary corrected by making minor changes to Operation. Verification of CHUID deployment scheduled for no earlier the working specification. We will make signature changed to mandatory. CHUID than November 29, 2004. such changes available to the public as signature is either verified once, either A series of Federal Register notices they occur, through use of the following when the card holder’s CHUID is have announced the implementation of link/Web site: www.tsa.gov/twic. In registered in a local PACS, or read by the test, beginning with a notice addition, we will address any necessary the TWIC reader each time the card is published on May 31, 2005 (70 FR changes to the working specification presented for access. 30964). As described in that document, prior to finalizing the regulations the deployment sites for the test have 4. Section 5.1.1, Device Dimensions. requiring TWIC readers. Note added to stress contactless reader been phased in as clusters. The ports sensitivity to location and Issued in Arlington, Virginia, on identified belonging to the first cluster electromagnetic conditions of their September 14, 2007. were announced in the May 31, 2005 environment. Stephanie Rowe, notice. Additional clusters were 5. Section 6, Portable Reader Assistant Administrator, Transportation announced in subsequent notices Requirements. Requirements for Threat Assessment and Credentialing, published in the Federal Register Transportation Security Administration. confidentiality and authentication including: 70 FR 43892, published on added for wireless devices used in [FR Doc. 07–4649 Filed 9–19–07; 8:45 am] July 29, 2005; 70 FR 60096, published physical access systems. BILLING CODE 4910–15–P on October 14, 2005; 71 FR 3875, published on January 24, 2006; 71 FR 6. Section 7, Operational 23941, published on April 25, 2006; 71 Requirements. Contactless transmission DEPARTMENT OF HOMELAND FR 42103, published on July 25, 2006; speed requirement changed to support SECURITY 71 FR 77404, published on December 106kbit/s, 212kbit/s or 424kbit/s, based 26, 2006; 72 FR 5070, published on on the card’s capabilities. Bureau of Customs and Border February 2, 2007; 72 FR 7058, published 7. Section 7, Operational Protection on February 14, 2007; 72 FR 14127, Requirements. Requirement added to Automated Commercial Environment published on March 26, 2007; and 72 FR reject transaction if multiple cards are 32135, published on June 11, 2007. simultaneously detected in the reader’s (ACE): National Customs Automation contactless field. Program Test of Automated Truck New Cluster 8. Section 8, Performance Manifest for Truck Carrier Accounts; Through this notice, CBP announces Requirements. Support for biometric Deployment Schedule that the final cluster of ports to be liveness detection strengthened from AGENCY: Customs and Border Protection; brought up for purposes of deployment ‘‘may’’ to ‘‘should’’ indicating a strong Department of Homeland Security. of the test, to be fully deployed no preference for liveness detection. ACTION: General notice. earlier than August 30, 2007, will be the 9. Appendix A.1, CHUID following land border ports in the state Authentication. CHUID authentication SUMMARY: Customs and Border of Alaska: Alcan, Dalton Cache, and clarified. Protection (CBP), in conjunction with Skagway. This group of ports is the last 10. Appendix A.2, TWIC Biometric the Department of Transportation, remaining group, nationwide, to be Authentication. Biometric Federal Motor Carrier Safety tested; the ACE truck manifest test will authentication clarified. Administration, is currently conducting be complete once it is effectuated in 11. Appendix A.3, Card a National Customs Automation Alaska. Authentication Key Authentication. Program (NCAP) test concerning the This deployment is for purposes of Card Authentication data object transmission of automated truck the test of the transmission of automated reference corrected. manifest data. This document truck manifest data only; the Automated Commercial Environment (ACE) Truck 12. Appendix A.3, Card announces the final group, or cluster, of Manifest System is not yet the mandated Authentication Key Authentication. ports to be deployed for this test. DATES: The ports identified in this transmission system for these ports. The Card Authentication Key usage clarified ACE Truck Manifest System will to indicate that it is only available via notice, in the state of Alaska, are expected to be fully deployed for testing become the mandatory transmission the PIV application, and is not shared system in these ports only after with the TWIC application. no earlier than August 30, 2007. Comments concerning this notice and publication in the Federal Register of 90 13. Appendix D, TWIC Reader days notice, as explained by CBP in the Compatibility with Other Card Types. all aspects of the announced test may be submitted at any time during the test Federal Register notice published on Reader compatibility and default card October 27, 2006 (71 FR 62922). support clarified and modified to allow period to the contact listed below. configuration of default AID. FOR FURTHER INFORMATION CONTACT: Mr. Previous NCAP Notices Not Concerning 14. Appendix E.4, Alternate James Swanson via e-mail at Deployment Schedules Implementations. Minor clarifications to [email protected]. On Monday, March 21, 2005, a notice PACS enrollment. SUPPLEMENTARY INFORMATION: was published in the Federal Register

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(70 FR 13514) announcing a for tariff classification purposes. additionally requested that CBP ensure modification to the NCAP test to clarify Chapter 64, HTSUS, covers footwear, the uniform interpretation and that all relevant data elements are gaiters and the like, and parts of such application of those criteria by CBP field required to be submitted in the articles. Disparities in the duty rates offices. automated truck manifest submission. applicable to some provisions under Preliminary Notice That notice did not announce any Heading 6403 in Chapter 64 are based change to the deployment schedule and on the gender of the user. Additional After receiving the above-referenced is not affected by publication of this U.S. Note 1(b) and Statistical Note 1(b) letter, CBP published a general notice in notice. All requirements and aspects of to Chapter 64, HTSUS, provide that the Federal Register (67 FR 18303) on the test, as set forth in the September 13, footwear ‘‘for men, youths and boys’’ April 15, 2002. In that document, CBP 2004 notice, as modified by the March covers footwear of certain men’s and set forth its criteria for determining 21, 2005 notice, continue to be youths’ sizes, not including unisex what constitutes unisex footwear for applicable. footwear (i.e., ‘‘footwear commonly tariff classification purposes as well as worn by both sexes’’). Statistical Note Dated: September 13, 2007. the criteria proposed by the FDRA. In 1(c) to Chapter 64, HTSUS, provides addition, CBP solicited comments on Thomas S. Winkowski, that footwear ‘‘for women’’ covers the appropriateness of the standards Assistant Commissioner, Office of Field footwear of certain women’s sizes, proposed by the FDRA and on the Operations. whether for females or of types extent to which any standards followed [FR Doc. E7–18527 Filed 9–19–07; 8:45 am] commonly worn by both sexes (i.e., by CBP in the past should be retained. BILLING CODE 9111–14–P unisex). Elsewhere in the HTSUS (in Suggestions for alternative standards subheadings 6403.99.75 and 6403.99.90, were also invited. Four comments were for example), footwear is classified as DEPARTMENT OF HOMELAND received in response to the preliminary ‘‘for other persons,’’ a definition that notice. SECURITY also includes unisex footwear. The Proposed Interpretive Rule U.S. Customs and Border Protection determination of whether footwear is classifiable as ‘‘for men, youths and CBP published a proposed [USCBP–2006–0021; CBP Dec. 07–78] boys’’ rather than ‘‘for women’’ or ‘‘for interpretive rule in the Federal Register other persons,’’ therefore, often rests on (71 FR 41822) on July 24, 2006. In the Interpretive Rule Concerning whether the footwear is truly for men, proposed interpretive rule, CBP Classification of Unisex Footwear youths and boys or is, in fact, unisex. reiterated its traditional criteria for AGENCY: U.S. Customs and Border The rates of duty applicable to footwear determining what constitutes unisex Protection, Department of Homeland ‘‘For other persons’’ (i.e. unisex) are footwear, addressed the four comments Security. about 1.5 percent higher than the rates received in response to the preliminary applicable to footwear ‘‘For men, youths ACTION: Final interpretion. notice, and proposed new criteria for and boys.’’ purposes of determining whether SUMMARY: This document adopts as It is noted that many types of footwear footwear should be considered unisex final, with minor changes, a proposed may be, and in fact are, worn by both for tariff classification purposes. The interpretive rule regarding the criteria to sexes. In addition, many types of shoes criteria set forth by CBP in the proposed be used by U.S. Customs and Border in male sizes do not feature physical interpretive rule, to be applied in Protection (‘‘CBP’’) to determine characteristics to designate that the sequential order, are: whether footwear is considered to be footwear is intended exclusively for (1) Footwear in sizes for men, youths ‘‘commonly worn by both sexes’’ males. The standards employed for and boys will not be considered to be (unisex) for tariff classification purposes purposes of determining whether ‘‘commonly worn by both sexes’’ (i.e., under Heading 6403 of the Harmonized footwear is considered unisex had been ‘‘unisex’’) if marked ‘‘MEN’S SIZE developed and applied by CBP on an ad Tariff Schedule of the United States ll’’, ‘‘YOUTHS’ SIZE ll’’, or hoc, case-by-case basis. This approach, (‘‘HTSUS’’) that was published in the ‘‘BOYS’ SIZE ll’’. while effective in individual cases, had Federal Register on July 24, 2006. The (2) Even if not marked as described in provided only limited guidance to the rates of duty applicable to footwear ‘‘For criterion 1, footwear in sizes for men, other persons’’ (i.e., ‘‘unisex’’) are about importing community and to CBP officers with respect to other import youths or boys will not be considered to 1.5 percent higher than the rates of duty be ‘‘commonly worn by both sexes’’ applicable to footwear ‘‘For men, youths transactions involving different factual circumstances. (i.e., ‘‘unisex’’) if: and boys.’’ The criteria set forth in this a. The importer imports the same shoe document will promote uniformity in Request From Public To Provide for women and girls, or; the classification of subject footwear, Enhanced Guidance b. Evidence is provided in the form of thereby ensuring that proper duties are In a letter dated September 17, 1999, marketing material, retail collected. the footwear importing public, advertisements, or other convincing DATES: Effective Date: October 22, 2007. represented by the Footwear documentation demonstrating that the FOR FURTHER INFORMATION CONTACT: Distributors and Retailers of America same shoe for women and girls is Alexandra (Sasha) Kalb, Tariff (‘‘FDRA’’), requested that CBP take steps available in the U.S. marketplace. Classification and Marking Branch, to provide enhanced guidance in (3) A style of footwear in sizes for Regulations and Rulings, Office of determinations concerning unisex males will not be presumed to be International Trade, (202) 572–8791. issues. The FDRA specifically requested ‘‘commonly worn by both sexes’’ (i.e., SUPPLEMENTARY INFORMATION: that CBP set forth the criteria for ‘‘unisex’’) unless evidence of marketing determining whether footwear claimed establishes that at least one pair in four Background to be ‘‘for men, youths and boys’’ is (25 percent) of that style is sold to and/ This document sets forth the criteria considered ‘‘commonly worn by both or worn by females. to be used by CBP to determine whether sexes’’ and therefore classifiable as (4) A determination that footwear is footwear should be considered ‘‘unisex’’ footwear ‘‘for other persons.’’ The FDRA ‘‘commonly worn by both sexes’’ will

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trigger ‘‘unisex’’ classification treatment indicate the required information to the Comment that is applicable to all sizes. ultimate purchaser in the United States. A commenter requested that CBP In addition to providing the proposed With respect to abbreviations, it is clarify criterion 2(b) by defining or classification criteria set forth above, CBP’s position that using ‘‘YTH’’ to explaining the meaning of ‘‘same’’ shoe. CBP solicited additional comments in indicate ‘‘YOUTHS’’’ is acceptable. the proposed interpretive rule. The However, CBP finds that the required CBP Response prescribed public comment period MEN’S or BOYS markings are already ‘‘Same’’ shoe in the context of closed on September 22, 2006. concise and that these markings do not criterion 2(b) means either having the Discussion of Comments lend themselves to abbreviation. same style number or name with a Consequently, the use of abbreviations female prefix or suffix to indicate Three submissions were received in for these markings is unnecessary and gender or, if not having the same style response to the solicitation of comments unacceptable. number or name, made with the same in the proposed interpretive rule. Two materials, with the same features and of the submissions were provided by a Thus, there are two possible methods for marking footwear under criterion (1) value, and designed for the same law firm on behalf of various footwear purpose as the subject shoe. importers. A separate law firm, on in order for such footwear not to be behalf of a trade association consisting considered ‘‘commonly worn by both Comment of footwear retailers, importers, and sexes’’ and trigger ‘‘unisex’’ A commenter stated that the final rule producers, provided the third classification. should clarify that marketing studies submission. A description of the various The first acceptable marking under ‘‘will be used sparingly at CBP’s comments contained in the criterion (1) is: MEN’S SIZE ll, discretion’’ and that conclusions made submissions, and CBP’s analysis related YOUTHS’ SIZE ll or BOYS’ as a result of the marketing studies can thereto, is set forth below. SIZEll. be applied to unliquidated and future Comment Alternatively, the second acceptable entries of footwear studied. marking under criterion (1) is: MEN’S CBP Response A commenter indicated that criterion SIZE ll, YTH SIZE ll, or BOYS’ (1) Is ambiguous on a number of SIZE ll. If the importer chooses not to mark practical points and suggested imported footwear in the manner amending it by permitting ‘‘clear Comment indicated in criterion (1) and no female abbreviations’’ to be used in the A commenter requested that a version of the subject footwear is marking, as well as permitting marking ‘‘gender symbol’’ be permitted to satisfy demonstrated to exist in the U.S. on just one shoe per pair, and marking the marking mentioned in criterion (1). marketplace as indicated in criterion (2), on stickers and hang tags instead of the and CBP determines that the footwear is shoes themselves. In addition, a CBP Response the type ‘‘commonly worn by both commenter requested that CBP state the If an importer chooses to mark sexes,’’ that footwear will be deemed minimum form or manner of marking footwear with gender symbols in ‘‘unisex’’ and entered accordingly. If an which footwear must have in order not addition to the marking in criterion (1), importer disagrees, CBP will consider to be considered ‘‘commonly worn by that will serve as further evidence that market surveys, submitted by the both sexes’’ under criterion (1). the footwear is ‘‘not commonly worn by importer, that establish that at least one CBP Response both sexes.’’ However, gender symbols pair in four (25 percent) of the subject alone will not satisfy CBP that the footwear is not sold to and/or worn by CBP requires that the country of females. Conclusions made as a result of origin be marked on both shoes in a pair footwear is ‘‘not commonly worn by both sexes.’’ the marketing studies will be applied to in order to ensure that the marking is all entries of the subject footwear whose conspicuous. The rationale behind this Comment liquidation is not final. requirement is that a prospective purchaser may inspect and try on only A commenter stated that it Comment one shoe for fit prior to purchase. understands that criterion (3) does not A commenter recommended that the Traditionally, size markings are also require an importer to conduct a market sequence of the criteria be revised so provided on both shoes in a pair. survey. Rather, the importer would that criterion (3) appears first because Accordingly, CBP requires that that the make entry based on its marketing ‘‘if there is no evidence establishing that marking described under criterion (1) approach. the footwear is sold to and/or worn by also be on both shoes in a pair. Since CBP Response females, the remaining three standards the country of origin already must do not come into play.’’ appear on both shoes, and because sizes CBP does not require the importer to also traditionally appear on both shoes, conduct a market survey. If the importer CBP Response we do not view this requirement as an chooses not to mark imported footwear Criterion (3) is a default rule which is undue burden to importers. in the manner indicated in criterion (1) to be implemented only when criterions Certain kinds of footwear, usually and no female version of the subject (1) and (2) do not apply. Criterion (3) is inexpensive shoes sold in retail footwear is demonstrated to exist, and only applicable in situations where the packages or bags, not the type that is CBP determines that the footwear is the importer has not marked the imported usually tried on for fit prior to purchase, type ‘‘commonly worn by both sexes,’’ footwear, no female version of the have been found to be legally marked by that footwear will be deemed ‘‘unisex’’ subject footwear is demonstrated to means of stickers or hang tags. CBP will and entered accordingly. If an importer exist in the U.S. marketplace, and CBP also accept stickers or hang tags on this disagrees, CBP will consider a market determines that the footwear is the type type of footwear as an indication that survey, submitted by the importer, that ‘‘commonly worn by both sexes.’’ As a the footwear is not ‘‘commonly worn by establishes that at least one pair in four result, the sequence of the criteria both sexes’’ if the marking is sufficiently (25 percent) of the subject footwear is cannot be revised so that default permanent, conspicuous, and legible to not sold to and/or worn by females. criterion (3) appears first.

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Comment Final Interpretive Rule requires this information to assure accuracy in the fee and premium billing A commenter requested that CBP The criteria to be utilized by CBP for determining whether footwear should programs under HUD–FHA’s automatic make it clear that non-U.S. sizes and data processing system. HUD uses the conversion charts will not be considered be considered to be ‘‘unisex’’ under Heading 6403, HTSUS, are: information to process premium in determining whether footwear is payments and to process claims. deemed ‘‘unisex’’ and that size/gender (1) Footwear in sizes for men, youths DATES: Comments Due Date: October 22, labels are controlling. and boys will not be considered to be ‘‘commonly worn by both sexes’’ (i.e., 2007. CBP Response ‘‘unisex’’) if marked ‘‘MEN’S SIZEll’’, ADDRESSES: Interested persons are ll invited to submit comments regarding CBP only requires that imported ‘‘YOUTHS’ (or YTH) SIZE ’’, or ll this proposal. Comments should refer to footwear bear country of origin ‘‘BOYS’ SIZE ’’. (2) Even if not marked as described in the proposal by name and/or OMB markings. The marking of imported criterion 1, footwear in sizes for men, approval Number (2502–0422) and footwear as described in criterion (1) is youths or boys will not be considered to should be sent to: HUD Desk Officer, entirely voluntary and is intended to be ‘‘commonly worn by both sexes’’ Office of Management and Budget, New assist CBP in the determination of (i.e., ‘‘unisex’’) if: Executive Office Building, Washington, whether or not footwear is ‘‘commonly a. The importer imports the same DC 20503; fax: 202–395–6974. worn by both sexes.’’ The size/gender style of shoe for women and girls, or; FOR FURTHER INFORMATION CONTACT: label will generally be controlling. b. Evidence is provided in the form of Lillian Deitzer, Departmental Reports Comment marketing material, retail Management Officer, QDAM, advertisements, or other convincing Department of Housing and Urban A commenter stated that if criterion documentation demonstrating that the Development, 451 Seventh Street, SW., (2) is to have any practical meaning, it same style of shoe for women and girls Washington, DC 20410; e-mail must be revised to permit a showing is available in the U.S. marketplace. [email protected] or that comparable footwear is available in (3) A style of footwear in sizes for telephone (202) 708–2374. This is not a women’s and girls’ sizes. males will not be presumed to be toll-free number. Copies of available CBP Response ‘‘commonly worn by both sexes’’ (i.e., documents submitted to OMB may be ‘‘unisex’’) unless evidence of marketing obtained from Ms. Deitzer or from CBP does not consider comparability establishes that at least one pair in four HUD’s Web site at http:// to be relevant to the determination of (25 percent) of that style is sold to and/ www5.hud.gov:63001/po/i/icbts/ whether a particular style is ‘‘unisex.’’ or worn by females. collectionsearch.cfm. CBP will consider marketing material, (4) A determination that footwear is retail advertisements, or other ‘‘commonly worn by both sexes’’ will SUPPLEMENTARY INFORMATION: This convincing documentation trigger ‘‘unisex’’ classification treatment notice informs the public that the demonstrating that the same style of that is applicable to all sizes. Department of Housing and Urban Development has submitted to OMB a shoe is available in the U.S. Dated: September 17, 2007. marketplace. request for approval of the information W. Ralph Basham, collection described below. This notice Comment Commissioner, U.S. Customs and Border is soliciting comments from members of Protection. A commenter recommended that CBP the public and affecting agencies [FR Doc. E7–18588 Filed 9–19–07; 8:45 am] indicate that an importer may rely on concerning the proposed collection of the size designations, whether or not BILLING CODE 9111–14–P information to: (1) Evaluate whether the there is a gender indication, in proposed collection of information is classifying footwear at the statistical necessary for the proper performance of level. DEPARTMENT OF HOUSING AND the functions of the agency, including URBAN DEVELOPMENT whether the information will have CBP Response practical utility; (2) Evaluate the [Docket No. FR–5117–N–83] accuracy of the agency’s estimate of the Size designation alone will generally burden of the proposed collection of determine the classification of footwear Notice of Submission of Proposed information; (3) Enhance the quality, unless the footwear is ‘‘commonly worn Information Collection to OMB; utility, and clarity of the information to by both sexes.’’ Mortgage Record Change be collected; and (4) Minimize the Conclusion AGENCY: Office of the Chief Information burden of the collection of information Officer, HUD. on those who are to respond; including Upon due consideration of the ACTION: Notice. through the use of appropriate comments received, CBP has decided to automated collection techniques or adopt as final the proposed interpretive SUMMARY: The proposed information other forms of information technology, rule, which was published in the collection requirement described below e.g., permitting electronic submission of Federal Register (71 FR 41822) on July has been submitted to the Office of responses. 24, 2006, with allowance made for the Management and Budget (OMB) for This notice also lists the following permitted abbreviation to criterion (1) review, as required by the Paperwork information: and minor editorial changes to criterion Reduction Act. The Department is Title of Proposal: Mortgage Record (2). Specifically, in order to clarify the soliciting public comments on the Change. requirements under criterion (2), criteria subject proposal. OMB Approval Number: 2502–0422. 2(a) and 2(b) in the final interpretive FHA-approved mortgagees report to Form Numbers: HUD–92080. rule will reference the ‘‘same style of HUD the sale of a mortgage between Description of the Need for the shoe’’ as opposed to the ‘‘same shoe’’. investors, the transfer of the mortgage Information and its Proposed Use: FHA- Thus, the final interpretive rule with the servicing responsibility, or a change in approved mortgagees report to HUD the minor changes is set forth below. mortgagors, as appropriate. HUD sale of a mortgage between investors,

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the transfer of the mortgage servicing accuracy in the fee and premium billing information to process premium responsibility, or a change in programs under HUD–FHA’s automatic payments and to process claims. mortgagors, as appropriate. HUD data processing system. HUD uses the Frequency of Submission: On requires this information to assure occasion.

Number of re- Annual re- Hours per re- spondents sponses x sponse = Burden hours

Reporting Burden ...... 2,600 615.4 .... 0.1 ...... 160.025

Total Estimated Burden Hours: guidelines to be eligible for HUD information to: (1) Evaluate whether the 160.025. mortgage insurance. Underwriters are proposed collection of information is Status: Extension of a currently required to sign and submit a copy of necessary for the proper performance of approved collection. the completed form to HUD for the functions of the agency, including Authority: Section 3507 of the endorsement as part of the case binder; whether the information will have Paperwork Reduction Act of 1995, 44 to provide a copy to the homebuyer; and practical utility; (2) Evaluate the U.S.C. 35, as amended. to maintain a copy for the mortgagee. accuracy of the agency’s estimate of the Dated: September 14, 2007. DATES: Comments Due Date: October 22, burden of the proposed collection of Lillian L. Deitzer, 2007. information; (3) Enhance the quality, Departmental Paperwork Reduction Act ADDRESSES: Interested persons are utility, and clarity of the information to Officer, Office of the Chief Information invited to submit comments regarding be collected; and (4) Minimize the Officer. this proposal. Comments should refer to burden of the collection of information [FR Doc. E7–18533 Filed 9–19–07; 8:45 am] the proposal by name and/or OMB on those who are to respond; including BILLING CODE 4210–67–P approval Number (2502–0494) and through the use of appropriate should be sent to: HUD Desk Officer, automated collection techniques or Office of Management and Budget, New other forms of information technology, DEPARTMENT OF HOUSING AND Executive Office Building, Washington, e.g., permitting electronic submission of URBAN DEVELOPMENT DC 20503; fax: 202–395–6974. responses. [Docket No. FR–5117–N–84] FOR FURTHER INFORMATION CONTACT: This notice also lists the following Lillian Deitzer, Departmental Reports information: Notice of Submission of Proposed Management Officer, QDAM, Title of Proposal: HUD Conditional Information Collection to OMB; HUD Department of Housing and Urban Commitment/Direct Endorsement Conditional Commitment/Direct Development, 451 Seventh Street, SW., Statement of Appraised Value. Endorsement Statement of Appraised Washington, DC 20410; e-mail OMB Approval Number: 2502–0494. Value [email protected] or telephone (202) 708–2374. This is not a Form Numbers: HUD–92800.5B. AGENCY: Office of the Chief Information toll-free number. Copies of available Description of the Need for the Officer, HUD. documents submitted to OMB may be Information and its Proposed Use: The ACTION: Notice. obtained from Ms. Deitzer or from information is used by appraisers and/ SUMMARY: The proposed information HUD’s Web site at http:// or underwriters upon their review of the collection requirement described below www5.hud.gov:63001/po/i/icbts/ appraisal report (URAR) to determine if has been submitted to the Office of collectionsearch.cfm. a property meets FHA guidelines to be Management and Budget (OMB) for SUPPLEMENTARY INFORMATION: This eligible for HUD mortgage insurance. review, as required by the Paperwork notice informs the public that the Underwriters are required to sign and Reduction Act. The Department is Department of Housing and Urban submit a copy of the completed form to soliciting public comments on the Development has submitted to OMB a HUD for endorsement as part of the case subject proposal. request for approval of the information binder; to provide a copy to the The information is used by appraisers collection described below. This notice homebuyer; and to maintain a copy for and/or underwriters upon their review is soliciting comments from members of the mortgagee. of the appraisal report (URAR) to the public and affecting agencies Frequency Of Submission: On determine if a property meets FHA concerning the proposed collection of occasion.

Number of re- Annual re- × Hours per spondents sponses reponse = Burden hours

Reporting Burden ...... 8,000 75 .... .12 .... 72,000

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Total Estimated Burden Hours: with current and future needs. information to: (1) Evaluate whether the 72,000. Additional information such as asking proposed collection of information is Status: Extension of a currently rent (or price for condominium units) necessary for the proper performance of approved collection. and number of bedrooms is also the functions of the agency, including Authority: Section 3507 of the collected. We also ask the availability of whether the information will have Paperwork Reduction Act of 1995, 44 services in ‘‘assisted living’’ buildings. practical utility; (2) Evaluate the U.S.C. 35, as amended. DATES: Comments Due Date: October 22, accuracy of the agency’s estimate of the Dated: September 14, 2007. 2007. burden of the proposed collection of Lillian L. Deitzer, ADDRESSES: Interested persons are information; (3) Enhance the quality, Departmental Paperwork Reduction Act invited to submit comments regarding utility, and clarity of the information to Officer, Office of the Chief Information this proposal. Comments should refer to be collected; and (4) Minimize the Officer. the proposal by name and/or OMB burden of the collection of information [FR Doc. E7–18534 Filed 9–19–07; 8:45 am] approval Number (2528–0013) and on those who are to respond; including BILLING CODE 4210–67–P should be sent to: HUD Desk Officer, through the use of appropriate Office of Management and Budget, New automated collection techniques or Executive Office Building, Washington, other forms of information technology, DEPARTMENT OF HOUSING AND DC 20503; fax: 202–395–6974. e.g., permitting electronic submission of URBAN DEVELOPMENT FOR FURTHER INFORMATION CONTACT: responses. [Docket No. FR–5117–N–85] Lillian Deitzer, Departmental Reports This notice also lists the following Management Officer, QDAM, information: Notice of Submission of Proposed Department of Housing and Urban Title of Proposal: Survey of Market Information Collection to OMB; Survey Development, 451 Seventh Street, SW., Absorption of New Apartment of Market Absorption of New Washington, DC 20410; e-mail Buildings. Apartment Buildings [email protected] or telephone (202) 708–2374. This is not a OMB Approval Number: 2528–0013. AGENCY: Office of the Chief Information toll-free number. Copies of available Form Numbers: H–31 (Questionnaire), Officer, HUD. documents submitted to OMB may be SOMA–1 (Introductory Letter). ACTION: Notice. obtained from Ms. Deitzer or from Description of the Need for the SUMMARY: The proposed information HUD’s Web site at http:// Information and its Proposed Use: The collection requirement described below www5.hud.gov:63001/po/i/icbts/ Department of Housing and Urban has been submitted to the Office of collectionsearch.cfm. Development conducts this survey in Management and Budget (OMB) for SUPPLEMENTARY INFORMATION: This order to determine if the supply of review, as required by the Paperwork notice informs the public that the rental housing is keeping pace with Reduction Act. The Department is Department of Housing and Urban current and future needs. Additional soliciting public comments on the Development has submitted to OMB a information such as asking rent (or price subject proposal. request for approval of the information for condominium units) and number of The Department of Housing and collection described below. This notice bedrooms is also collected. We also ask Urban Development conducts this is soliciting comments from members of the availability of services in ‘‘assisted survey in order to determine if the the public and affecting agencies living’’ buildings. supply of rental housing is keeping pace concerning the proposed collection of Frequency of Submission: Quarterly.

Number of Re- Annual Re- Hours per Re- spondents sponses x sponse = Burden hours

Reporting Burden: ...... 12,000 3 .... .116 .... 4,200

Total Estimated Burden Hours: 4,200. DEPARTMENT OF HOUSING AND SW., Room 5148, Washington, DC Status: Extension of a currently URBAN DEVELOPMENT 20410, telephone (202) 402–4778. This is not a toll-free number. approved collection. [Docket No. FR–5155–N–02] SUPPLEMENTARY INFORMATION: Pursuant Authority: Section 3507 of the Notice of FHA Debenture Call to section 207(j) of the National Housing Paperwork Reduction Act of 1995, 44 Act, 12 U.S.C. 1713(j), and in U.S.C. 35, as amended. AGENCY: Office of the Assistant accordance with HUD’s regulations at Dated: September 14, 2007. Secretary for Housing—Federal Housing 24 CFR 207.259(e)(3), the Assistant Lillian L. Deitzer, Commissioner, HUD. Secretary for Housing-Federal Housing Commissioner, with the approval of the Departmental Paperwork Reduction Act ACTION: Notice. Officer, Office of the Chief Information Secretary of HUD and the Secretary of SUMMARY: This Notice announces a Officer. the Treasury, announces the call of all debenture recall of certain Federal FHA debentures, with a coupon rate of [FR Doc. E7–18535 Filed 9–19–07; 8:45 am] Housing Administration (FHA) 6.25 percent or above, except for those BILLING CODE 4210–67–P debentures, in accordance with debentures subject to ‘‘debenture lock authority provided in the National agreements,’’ that have been registered Housing Act. on the books of the Bureau of Public FOR FURTHER INFORMATION CONTACT: Debt, Department of the Treasury, and Yong Sun, FHA Financial Reporting are, therefore, ‘‘outstanding’’ as of Division, Department of Housing and September 30, 2007. The date of the call Urban Development, 451 Seventh Street, is January 1, 2008.

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The debentures will be redeemed at 60604, and refer to United States v. Natural Resources Division, and either par plus accrued interest. Interest will Richard Reid, Lee Reid and Redesign’ e-mailed to pubcomment- cease to accrue on the debentures as of Landscape Contractors, Inc., Civ. No. [email protected] or mailed to P.O. the call date. At redemption, final 06–1103. Box 7611, U.S. Department of Justice, interest on any called debentures will be The proposed Consent Decree may be Washington, D.C. 20044–7611, and paid along with the principal. Payment examined at the Clerk’s Office, United should refer to United States v. Bayer of final principal and interest due on States District Court for the Northern Healthcare LLC et al., D.J. Reference No. January 1, 2008 will be made District of Illinois, Everett McKinley 90–112–865/1. automatically to the registered holder. Dirksen Building, 219 South Dearborn The proposed Consent Decree may be During the period from the date of Street, Chicago, Illinois 60604. In examined at the Offices of the United this notice to the call date, debentures addition, the proposed Consent Decree States Attorney, 5400 Federal Plaza, that are subject to the call may not be may be viewed at http://www.usdoj.gov/ Suite 1500, Hammond, IN 46320, and at used by the mortgagee for a special enrd/Consent_Decrees.html. U.S. EPA Region V, 77 West Jackson Boulevard, Chicago, IL 60604. During redemption purchase in payment of a Scott Schachter, mortgage insurance premium. the public comment period, the Assistant Chief, Environmental Defense proposed Consent Decree may also be No transfer of debentures covered by Section, Environment & Natural Resources the foregoing call will be made on the Division. examined on the following Department of Justice Web site: http:// books maintained by the Treasury [FR Doc. 07–4664 Filed 9–19–07; 8:45 am] Department on or after December 14, www.usdoj.gov/enrd/ BILLING CODE 4410–15–M _ 2007. This debenture call does not affect Consent Decrees.html. A copy of the the right of the holder of a debenture to proposed Consent Decree may also be sell or assign the debenture on or after DEPARTMENT OF JUSTICE obtained by mail from the Consent this date. Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC Dated: September 10, 2007. Notice of Lodging of Consent Decree Under Cercla 20044–7611 or by faxing or e-mailing a Brian D. Montgomery, request to Tonia Fleetwood Assistant Secretary for Housing—Federal Notice is hereby given that on ([email protected]), fax number Housing Commissioner. September 7, 2007, a proposed Consent (202) 514–0097, phone confirmation [FR Doc. E7–18525 Filed 9–19–07; 8:45 am] Decree in United States v. Bayer number (202) 514–1547. When BILLING CODE 4210–67–P Healthcare LLC et al., Civil Action No. requesting a copy from the Consent 2:07CV304 (TS), was lodged with the Decree Library, please enclose a check United States District Court for the in the amount of $51.75 for the Consent DEPARTMENT OF JUSTICE Northern District of Indiana. Decree (25 cents per page reproduction The proposed Consent Decree cost), payable to the U.S. Treasury or, if Notice of Lodging Proposed Consent resolves the United States’ claims for by e-mail or fax, forward a check in that Decree performance of response actions and amount to the Consent Decree Library at recovery of response costs under the stated address. In accordance with Departmental sections 106 and 107(a) of the Policy, 28 CFR 50.7, notice is hereby Comprehensive Environmental William D. Brighton, given that a proposed Consent Decree in Response, Compensation and Liability Assistant Chief, Environmental Enforcement United States v. Richard Reid, Lee Reid Act, 42 U.S.C. 9606(a) and 9607, against Section, Environment and Natural Resources and Redesign’ Landscape Contractors, 31 parties that owned, operated or Division. Inc., Civ. No. 06–1103, was lodged with arranged for disposal of hazardous [FR Doc. 07–4646 Filed 9–19–07; 8:45 am] the United States District Court for the waste at the Himco Dump Superfund BILLING CODE 4410–15–M Northern District of Illinois on Site in Elkhart, Indiana. The Consent September 13, 2007. This proposed Decree requires Bayer Healthcare LLC, a Consent Decree concerns a complaint legal successor to an entity that owned DEPARTMENT OF JUSTICE filed by the United States against part of the Site and generated waste Notice of Lodging Proposed Consent Richard Reid, Lee Reid and Redesign’ disposed of at the site and Himco Waste Decree Landscape Contractors, Inc., pursuant to Away, Inc., which operated a landfill at Section 301(a) of the Clean Water Act the Site, to implement a remedial action In accordance with Departmental (‘‘CWA’’), 33 U.S.C. 1311(a), to obtain selected by the U.S. Environmental Policy, 28 CFR 50.7, notice is hereby injunctive relief from and impose civil Protection Agency, at an estimated cost given that a proposed Consent Decree in penalties against the Defendants for of some $9,156,000. These entities, United States v. Randy Johnson, Civ. violating the Clean Water Act by together with 29 former customers of the No. 07–1048, was lodged with the discharging pollutants without a permit landfill, will also pay some $3,875,000 United States District Court for the into waters of the United States. The in past costs incurred by EPA in District of Minnesota on September 7, proposed Consent Decree resolves these connection with the Site. The proposed 2007. This proposed Consent Decree allegations by requiring the Defendants Decree also provides for reimbursement concerns a complaint filed by the to a pay a civil penalty. The Defendants of past costs incurred by the State of United States against Randy Johnson, have restored the impacted area. Indiana, which will be a co-plaintiff in pursuant to section 301(a) of the Clean The Department of Justice will accept the case. Water Act (‘‘CWA’’), 33 U.S.C. 1311(a), written comments relating to this The Department of Justice will to obtain injunctive relief from and proposed Consent Decree for thirty (30) receive, for a period of thirty (30) days impose civil penalties against the days from the date of publication of this from the date of this publication, Defendant for violating the Clean Water Notice. Please address comments to comments relating to the proposed Act by discharging pollutants without a Donald R. Lorenzen, United States Consent Decree. Comments should be permit into waters of the United States. Attorney’s Office, 219 South Dearborn addressed to the Acting Assistant The proposed Consent Decree resolves Street, 5th Floor, Chicago, Illinois Attorney General, Environment and these allegations by requiring the

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Defendant to restore the impacted areas The Discharges occurred between an importer of the basic classes of and to pay a civil penalty. approximately November 2005 and controlled substances listed in schedule The Department of Justice will accept November 1, 2006. I and II: written comments relating to this Under the settlement, Meridian will proposed Consent Decree for thirty (30) take a number of actions to enhance its Drug Schedule days from the date of publication of this efforts to inspect, monitor, maintain, Notice. Please address comments to and repair its Weeks Island facilities in Heroin (9200) ...... I Patricia R. Cangemi, 600 U.S. order to prevent and respond more Cocaine (9041) ...... II Courthouse, 300 South Fourth Street, quickly to future unauthorized Codeine (9050) ...... II Minneapolis, MN 55415 and refer to discharges. In addition, Meridian will Meperidine (9230) ...... II United States v. Randy Johnson, Civ. pay a civil penalty of $504,000. Methadone (9250) ...... II No. 07–1048, DJ # 90–5–1–1–18123. Comments should be addressed to the Morphine (9300) ...... II The proposed Consent Decree may be Acting Assistant Attorney General, examined at the Clerk’s Office, United Environment and Natural Resources The company plans to import these States District Court for the District of Division, and may be submitted to: P.O. controlled substances for the Minnesota, 202 U.S. Courthouse, 300 S. Box 7611, U.S. Department of Justice, manufacture of reference standards. 4th Street, Minneapolis, MN 55415. In Washington, DC 20044–7611, or via e- addition, the proposed Consent Decree mail to pubcomment- No comments or objections have been may be viewed at http://www.usdoj.gov/ [email protected]. and should refer to received. DEA has considered the enrd/Consent_Decree.html. United States v. The Meridian Resource factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Scott Schachter, & Exploration LLC et al., D.J. Ref. 90– 5–1–1–08993. Applied Science Labs to import the Assistant Chief, Environmental Defense basic classes of controlled substances is Section, Environment & Natural Resources The Consent Decree may be examined Division. at the Office of the United States consistent with the public interest and [FR Doc. 07–4647 Filed 9–19–07; 8:45 am] Attorney, Western District of Louisiana, with United States obligations under 800 Lafayette Street, Suite 2200, international treaties, conventions, or BILLING CODE 4410–15–M Lafayette, Louisiana 70501. During the protocols in effect on May 1, 1971, at public comment period the Meridian this time. DEA has investigated Applied DEPARTMENT OF JUSTICE Consent Decree may also be examined Science Labs to ensure that the on the following Department of Justice company’s registration is consistent Notice Of Public Comment Period for Web site: http://www.usdoj.gov/enrd/ with the public interest. The _ Proposed Clean Water Act Consent Consent Decrees.html. A copy of the investigation has included inspection Decree Meridian Consent Decree also may be and testing of the company’s physical obtained by mail from the Consent Under 28 CFR 50.7, notice is hereby security systems, verification of the Decree Library, P.O. Box 7611, U.S. given that, for a period of 30 days, the company’s compliance with state and Department of Justice, Washington, DC United States will receive public local laws, and a review of the 20044–7611 or by faxing or e-mailing a comments on a proposed Consent company’s background and history. request to Tonia Fleetwood Decree in United States v. The Meridian Therefore, pursuant to 21 U.S.C. 952(a) ([email protected]), fax no. Resource & Exploration LLC et al. and 958(a), and in accordance with 21 (202) 514–0097, phone confirmation (‘‘Meridian Consent Decree’’) (Civil number (202) 514–1547. In requesting a CFR 1301.34, the above named company Action No. 07–1482), which was lodged copy from the Consent Decree Library, is granted registration as an importer of with the United States District Court for please enclose a check in the amount of the basic classes of controlled the Western District of Louisiana on $7.50 (25 cents per page reproduction substances listed. September 6, 2007. This proposed Consent Decree was cost) payable to the U.S. Treasury. Dated: September 13, 2007. lodged simultaneously with the Thomas A. Mariani, Jr., Joseph T. Rannazzisi, Complaint in this Clean Water Act case Assistant Section Chief, Environmental Deputy Assistant Administrator, Office of against The Meridian Resource & Enforcement Section, Environment and Diversion Control, Drug Enforcement Exploration LLC and Louisiana Onshore Natural Resources Division. Administration. Properties LLC (collectively, [FR Doc. 07–4648 Filed 9–19–07; 8:45 am] [FR Doc. E7–18501 Filed 9–19–07; 8:45 am] ‘‘Meridian’’). The Complaint alleges that BILLING CODE 4410–15–M BILLING CODE 4410–09–P Meridian is civilly liable for violations of the Clean Water Act (‘‘CWA’’), 33 U.S.C. 1251 et seq., as amended by the DEPARTMENT OF JUSTICE Oil Pollution Act of 1990 (‘‘OPA’’), 33 U.S.C. 2701 et seq. The Complaint seeks Drug Enforcement Administration civil penalties and injunctive relief for Importer of Controlled Substances; five unauthorized discharges of crude Notice of Registration oil into navigable waters of the United States or adjoining shorelines from By Notice dated June 26, 2007 and Meridian’s operations at the Weeks published in the Federal Register on Island field in Iberia Parish, Louisiana. July 3, 2007 (72 FR 36480–36481), In particular, the Complaint alleges that Applied Science Labs, Division of approximately 747 barrels of crude oil Alltech Associates Inc., 2701 Carolean were discharged from two pipelines and Industrial Drive, State College, an oil well owned by Louisiana Onshore Pennsylvania 16801, made application Properties LLC and operated by The by renewal to the Drug Enforcement Meridian Resource & Exploration LLC. Administration (DEA) to be registered as

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NUCLEAR REGULATORY capabilities of their designs. The NRC which is underway, because the EPAct COMMISSION derived these characteristics from fingerprinting and criminal history agency analyses performed on operating records check requirements for access to [EA–07–231 Docket Nos. 52–001, 52–003, reactors to support, in part, the SGI were effective immediately upon 52–006, 52–010, and Project Nos. 0733 and 0751] development of a broadly effective set of enactment of the EPAct. Therefore, in mitigation strategies to combat fires and accordance with Section 149 of the In the Matter of Westinghouse Electric explosions from a spectrum of AEA, as amended by the EPAct, the Company, General Electric-Hitachi hypothetical aircraft impacts. Although Commission is imposing additional Nuclear Energy, Mitsubishi Nuclear these detailed characteristics were not requirements for access to SGI, as set Energy Systems, Inc., AREVA NP, and selected as a basis for designing new forth by this Order, so that the affected All Other Persons Who Seek or Obtain reactors, the staff is suggesting them as vendors can obtain and grant access to Access to Safeguards Information a starting point for aircraft impact SGI. This Order also requires Described Herein; Order Imposing assessments. As proposed by the compliance with the safeguards Safeguards Information Protection Commission, the Commission would protection measures set forth in 10 CFR Requirements and Fingerprinting and specify in a Safeguards Information 73.21, ‘‘Requirements for the Protection Criminal History Records Check guidance document the detailed aircraft of Safeguards Information,’’ and Requirements for Access to impact characteristics that should be imposes requirements for access to and Safeguards Information (Effective used in a required assessment of the protection of SGI by any person,2 Immediately) new reactor designs. The agency will whether or not they are a licensee, finalize the form and values of those applicant, or certificate holder of the I detailed characteristics when Commission or an Agreement State. Westinghouse Electric Company, LLC. completing the associated rulemaking. To implement this Order, the affected (WEC), holds certificates for the AP600 In addition, the staff recognizes that no vendors must nominate an individual and AP1000 reactor designs issued by national or international consensus has who will review the results of the FBI the U.S. Nuclear Regulatory been reached on the selection of criminal history records check to make Commission (NRC) in accordance with appropriate characteristics for such SGI access determinations. This the Atomic Energy Act of 1954, as analyses. Therefore, the information individual, referred to as the ‘‘reviewing amended (AEA). General Electric– should be considered preliminary and official,’’ must be someone who seeks Hitachi Nuclear Energy (GEH) holds a subject to authorized stakeholder access to SGI. Based on the results of the certificate for the ABWR reactor comment. The detailed aircraft FBI criminal history records check, the designed and has submitted an characteristics that are the subject of NRC staff will determine whether this application for design certification for this Order are hereby designated as individual may have access to SGI. If the Economic and Simplified Boiling Safeguards Information (SGI),1 in the NRC determines that the individual Water Reactor design in accordance accordance with Section 147 of the may not be granted access to SGI, the with the AEA and Title 10, Part 52, AEA. enclosed Order prohibits that individual ‘‘Early Site Permits; Standard Design The NRC is issuing this Order to the from obtaining access to any SGI. Once Certifications; and Combined Licenses affected vendors to impose requirements the NRC approves a reviewing official, for Nuclear Power Plants,’’ of the Code for the protection of SGI, as well as for that reviewing official, and only that of Federal Regulations (10 CFR Part 52), the fingerprinting of all persons who reviewing official, can make SGI access which the NRC staff is currently have or seek access to this SGI. This determinations for other individuals considering. Mitsubishi Nuclear Energy Order supercedes EA–07–154, issued to who have been identified by the affected Systems, Inc. (Mitsubishi), and AREVA WEC on June 8, 2007, and EA–07–159, vendors as having a need to know SGI, NP (AREVA) have both indicated to the issued to GEH, formerly General Electric and who have been fingerprinted and NRC that they plan to submit Company (GE), on June 15, 2007. Except have had a criminal history records applications for design certifications in for the restrictions on storage of SGI and check in accordance with this Order. the near future. WEC, GEH, Mitsubishi, access to SGI by certain individuals, this The reviewing official can only make and AREVA will be referred to herein as Order is identical to the Orders SGI access determinations for other ‘‘the affected vendors.’’ previously issued to WEC and GEH. individuals, but cannot approve other The Commission has decided to Therefore, since both vendors have individuals to act as reviewing officials. require, through rulemaking, that already complied with those orders, Only the NRC can approve a reviewing nuclear power plant designers perform WEC and GEH need only respond to this official. Therefore, if the affected a rigorous assessment of design features Order with an answer consenting to the vendors wish to have a new or that could provide additional inherent Order pursuant to Section IV. additional reviewing official, the NRC protection to avoid or mitigate the On August 8, 2005, Congress enacted must approve that individual before he effects of a large commercial aircraft the Energy Policy Act of 2005 (EPAct). or she can act in the capacity of a impact, while reducing or eliminating Section 652 of the EPAct amended reviewing official. the need for operator actions, where Section 149 of the AEA to require 2 practicable. In anticipation of this fingerprinting and a Federal Bureau of Person means (1) any individual, corporation, Investigation (FBI) identification and partnership, firm, association, trust, estate, public requirement, and to assist designers in or private institution, group, government agency completing this assessment, the criminal history records check of any other than the Commission or the Department of Commission has decided to provide the person who is permitted to have access Energy, (except that the Department of Energy shall detailed aircraft impact characteristics to SGI. The NRC’s implementation of be considered a person with respect to those this requirement cannot await the facilities of the Department of Energy specified in that should be used as reasonable inputs Section 202 of the Energy Reorganization Act of for reactor vendors and architect/ completion of the SGI rulemaking, 1974 (88 Stat. 1244)), any State or any political engineers who have the need to know subdivision of, or any political entity within a State, 1 SGI is a form of sensitive, unclassified, security- any foreign government or nation or any political and who meet the NRC’s requirements related information that the Commission has the subdivision of any such government or nation, or for the disclosure of such information to authority to designate and protect under Section other entity; and (2) any legal successor, use in studies of the inherent 147 of the AEA. representative, agent, or agency of the foregoing.

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Certain categories of individuals are Commission’s regulations in 10 CFR conducted by a local, State, or foreign relieved by rule from the fingerprinting 2.202 and 10 CFR Part 73, ‘‘Physical governmental agency, and/or enhanced requirements pursuant to 10 CFR 73.59, Protection of Plants and Materials,’’ it is background checks including ‘‘Relief from Fingerprinting and hereby ordered, effective immediately, employment and credit history. The Criminal History Records Check for that the affected vendors and all other NRC must review these additional Designated Categories of Individuals.’’ persons who seek or obtain access to measures and approve them in writing. Those individuals include: Federal, safeguards information as described B. No person may provide SGI to any State, and local law enforcement herein shall comply with the other person except in accordance with personnel; Agreement State inspectors requirements set forth in 10 CFR 73.21 Condition III.A. above. Before providing who conduct security inspections on and this order. SGI to any person, a copy of this Order behalf of the NRC; members of Congress; A. 1. No person may have access to shall be provided to that person. certain employees of members of SGI unless that person has a need to C. Each of the affected vendors shall Congress or congressional committees know the SGI, has been fingerprinted comply with the following who have undergone fingerprinting for and undergone an FBI identification and requirements: a prior U.S. Government criminal criminal history records check, and 1. The affected vendor shall, within history check; and representatives of the satisfies all other applicable 20 days of the date of this Order, International Atomic Energy Agency or requirements for access to SGI. establish and maintain a fingerprinting certain foreign government Fingerprinting and the FBI program that meets the requirements of organizations. In addition, individuals identification and criminal history 10 CFR 73.21 and the attachment to this who have had a favorably-decided U.S. records check are not required, Order. Government criminal history check however, for any person who is relieved 2. The affected vendor shall, within within the last 5 years, or individuals from the requirement by 10 CFR 73.59, 20 days of the date of this Order, submit who have active Federal security who has had a favorably decided U.S. the fingerprints of one individual whom clearances (provided in either case that Government criminal history check (a) the affected vendor nominates as the they make available the appropriate within the last 5 years, or who has an ‘‘reviewing official’’ for determining documentation), have already been active Federal security clearance, access to SGI by other individuals and subjected to fingerprinting and criminal provided in the latter two cases that the (b) has an established need to know the history checks and, thus, have satisfied affected vendor’s NRC-approved information. The NRC will determine the EPAct fingerprinting requirement. reviewing official has documented the whether this individual (or any existence of an active clearance or the subsequent reviewing official) may have II basis for relief. access to SGI and, therefore, will be The Commission has broad statutory 2. No person may have access to any permitted to serve as the affected authority to protect and prohibit the SGI if the NRC, when making an SGI vendor’s reviewing official.3 The unauthorized disclosure of SGI. Section access determination for a nominated affected vendor may, at the same time 147 of the AEA grants the Commission reviewing official, has determined, or later, submit the fingerprints of other explicit authority to issue such Orders, based on fingerprinting and an FBI individuals to whom the affected as necessary, to prohibit the identification and criminal history vendor seeks to grant access to SGI. unauthorized disclosure of SGI. records check, that the person Fingerprints shall be submitted and Furthermore, as discussed above, nominated may not have access to SGI. reviewed in accordance with the Section 652 of the EPAct amended 3. The affected vendor shall store SGI procedures described in the attachment Section 149 of the AEA to require designated by this Order only in the to this Order. fingerprinting and an FBI identification facility or facilities specifically 3. The affected vendor may allow any and a criminal history records check of approved in writing by the NRC for individual who currently has access to each individual who seeks access to storage of SGI designated by this Order. SGI to continue to have access to SGI. In addition, no person may have The affected vendor may request, in previously-designated SGI without access to SGI unless the person has an writing, NRC approval of additional being fingerprinted, pending a decision established need to know. facilities for the storage of the SGI by the NRC-approved reviewing official To provide assurance that the affected designated by this Order that the NRC (based on fingerprinting and an FBI vendors are continuing to implement will consider on a case-by-case basis. criminal history records check) that the appropriate measures to ensure a 4. The affected vendor may provide individual may continue to have access consistent level of protection to prohibit SGI designated by this Order to to SGI. The affected vendor shall make unauthorized disclosure of SGI, and to individuals (such as foreign nationals, determinations on continued access to comply with the fingerprinting and U.S. citizens living in foreign countries, SGI within 90 days of the date of this criminal history records check or individuals under the age of 18) for Order, in part, based on the results of requirements for access to SGI, the whom fingerprinting and an FBI the fingerprinting and criminal history affected vendors shall implement the criminal history records check is not check, for those individuals who were requirements for the protection of SGI as reasonably expected to yield sufficient previously granted access to SGI before set forth in 10 CFR 73.21 and this Order. criminal history information to form the the issuance of this Order. In addition, pursuant to 10 CFR 2.202, basis of an informed decision on 4. The affected vendor shall, in ‘‘Orders,’’ I find that in light of the granting access to SGI, provided that the writing, within 20 days of the date of matters identified above, which warrant individual satisfies the requirements of this Order, notify the Commission: (1) If the issuance of this Order, the public this Order, and that the affected vendor it is unable to comply with any of the health, safety, and interest require that has implemented measures, in addition requirements described in the Order, this Order be effective immediately. to those set forth in this Order, to ensure including the attachment; or (2) if that the individual is suitable for access III to the SGI designated by this Order. 3 The NRC’s determination of this individual’s access to SGI in accordance with the process Accordingly, pursuant to Sections Such additional measures must include, described in Enclosure 3 to the transmittal letter of 147, 149, 161b, 161i, 161o, 182, and 186 but are not limited to, equivalent this Order is an administrative determination that of the AEA of 1954 as amended, and the criminal history records checks is outside the scope of this Order.

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compliance with any of the Office of the General Counsel either by reviewing official whom the NRC has requirements is unnecessary in its means of facsimile transmission to (301) determined may not have access to SGI specific circumstances. The notification 415–3725 or via e-mail to shall, to the extent provided below, be shall provide the affected vendor’s [email protected]. If an entity afforded an opportunity to challenge justification for seeking relief from, or other than the affected vendor requests and appeal the NRC’s determination. variation of, any specific requirement. a hearing, that entity shall set forth, This policy shall not be construed to The affected vendors shall submit with particularity, the manner in which require the disclosure of SGI to any responses to C.1., C.2., C.3, and C.4 this Order adversely affects its interest person, nor shall it be construed to above to the Director, Office of New and shall address the criteria set forth in create a liberty or property interest of Reactors, U.S. Nuclear Regulatory 10 CFR 2.309, ‘‘Hearing Requests, any kind in the access of any individual Commission, Washington, DC 20555. In Petitions to Intervene, Requirements for to SGI. addition, the affected vendors shall Standing, and Contentions.’’ 2. Applicability mark their responses as ‘‘Security- If the affected vendor, or a person Related Information—Withhold Under whose interest is adversely affected, This policy applies solely to those 10 CFR 2.390.’’ requests a hearing, the Commission will employees of licensees who are The Director, Office of New Reactors, issue an Order designating the time and nominated as a reviewing official, and may, in writing, relax or rescind any of place of any hearing. If a hearing is held, who are thus considered, by the NRC, the above conditions upon the issue to be considered at such for initial or continued access to SGI in demonstration of good cause by the hearing shall be whether this Order that position. affected vendor. should be sustained. 3. SGI Access Determination Criteria IV Pursuant to 10 CFR 2.202(c)(2)(i), the affected vendor may, in addition to Determinations for granting a In accordance with 10 CFR 2.202, the demanding a hearing, at the time the nominated reviewing official access to affected vendor must, and any other answer is filed or sooner, move the SGI will be made by the NRC staff. person adversely affected by this Order presiding officer to set aside the Access to SGI shall be denied or may, submit an answer to this Order immediate effectiveness of the Order on revoked whenever it is determined that and may request a hearing with regard the grounds that the Order, including an individual does not meet the to this Order, within 20 days of the date the need for immediate effectiveness, is applicable standards. Any doubt about of this Order. Where good cause is not based on adequate evidence, but on an individual’s eligibility for initial or shown, the NRC will consider extending mere suspicion, unfounded allegations, continued access to SGI shall be the time to request a hearing. A request or error. In the absence of any request resolved in favor of the national security for extension of time in which to submit for hearing, or written approval of an and access will be denied or revoked. an answer or request a hearing must be extension of time in which to request a made in writing to the Director, Office 4. Procedures To Challenge the Contents hearing, the provisions as specified of New Reactors, U.S. Nuclear of Records Obtained From the FBI above in Section III shall be final 20 Regulatory Commission, Washington, a. Prior to a determination by the NRC days from the date of this Order DC 20555, and include a statement of Facilities Security Branch Chief that an without, further order or proceedings. If good cause for the extension. The individual nominated as a reviewing the agency approves an extension of answer may consent to this Order. official is denied or revoked access to time for requesting a hearing, the Unless the answer consents to this SGI, the individual shall: provisions, as specified above in Section Order, the answer shall, in writing and (i) Be provided the contents of records under oath or affirmation, specifically III, shall be final when the extension obtained from the FBI for the purpose of set forth the matters of fact and law by expires, if a hearing request has not assuring correct and complete which the affected vendor or other been received. information. If, after reviewing the An answer or a request for hearing entities adversely affected rely, and the record, an individual believes that it is shall not stay the immediate reasons as to why the NRC should not incorrect or incomplete in any respect effectiveness of this order. have issued this Order. Any answer or and wishes to change, correct, or update request for a hearing shall be submitted Dated this 12th day of September, 2007. the alleged deficiency, or to explain any to the Secretary, Office of the Secretary, * * * * * matter in the record, the individual may U.S. Nuclear Regulatory Commission, For the Nuclear Regulatory Commission. initiate challenge procedures. These ATTN: Rulemakings and Adjudications R.W. Borchardt, procedures include either direct Staff, Washington, DC 20555. Copies Director, Office of New Reactors. application by the individual shall also be sent to the Director, Office challenging the record to the agency of New Reactors, U.S. Nuclear Enclosure 3—Process To Challenge (i.e., law enforcement agency) that Regulatory Commission, Washington, NRC Denials or Revocations of Access contributed the questioned information, DC 20555, to the Assistant General to Safeguards Information or direct challenge as to the accuracy or Counsel for Materials Litigation and 1. Policy completeness of any entry on the Enforcement at the same address, and to criminal history record to the Assistant This policy establishes a process for the affected vendor, if the answer or Director, Federal Bureau of individuals whom the Nuclear hearing request is by an entity other Investigation, Identification Division, Regulatory Commission (NRC) licensees than the affected vendor. Because of Washington, DC 20537–9700 (as set or other person 1 nominate as reviewing possible delays in delivery of mail to forth in 28 CFR 16.30 through 16.34). In officials to challenge and appeal NRC U.S. Government offices, the agency the latter case, the FBI will forward the denials or revocations of access to asks that answers and requests for challenge to the agency that submitted Safeguards Information (SGI). Any hearing be transmitted to the Secretary the data and request that agency to individual nominated as a licensee of the Commission, either by means of verify or correct the challenged entry. facsimile transmission to (301) 415– 1 As used herein, ‘‘licensee’’ means any licensee Upon receipt of an official 1101 or via e-mail to or other person who is required to conduct communication directly from the agency [email protected], and also to the fingerprinting. that contributed the original

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information, the FBI Identification place at the NRC’s headquarters, and security clearance or reviewed the Division makes any necessary changes shall be at the individual’s own criminal history records check must be in accordance with the information expense. The determination by the provided. The licensee must retain this supplied by that agency. Director, Division of Facilities and documentation for a period of three (3) (ii) Be afforded ten (10) days to Security, shall be rendered within sixty years from the date the individual no initiate an action challenging the results (60) days after receipt of the appeal. longer requires access to SGI associated of an FBI criminal history records check with the licensee’s activities. 8. Procedures To Notify an Individual of (described in (I), above) after the record 4. All fingerprints obtained by the the Determination by the Director, is made available for the individual’s licensee pursuant to this Order must be Division of Facilities and Security, Upon review. If such a challenge is initiated, submitted to the Commission for an Appeal the NRC Facilities Security Branch transmission to the FBI. Chief may make a determination based a. A determination by the Director, 5. The licensee shall review the upon the criminal history record only Division of Facilities and Security, shall information received from the FBI and upon receipt of the FBI’s ultimate be provided to the individual in writing, consider it, in conjunction with the confirmation or correction of the record. and include an explanation of the basis trustworthiness and reliability for this determination. A determination requirements included in Attachment 2 5. Procedures To Provide Additional by the Director, Division of Facilities to this Order, in making a determination Information and Security, to affirm the Facilities whether to grant access to SGI to a. Prior to a determination by the NRC Branch Chief’s determination to deny or individuals who have a need-to-know Facilities Security Branch Chief that an revoke an individual’s access to SGI is the SGI. individual nominated as a reviewing final and not subject to further 6. The licensee shall use any official is denied or revoked access to administrative appeals. information obtained as part of a SGI, the individual shall: criminal history records check solely for Attachment—Requirements for the purpose of determining an (i) Be afforded an opportunity to Fingerprinting and Criminal History individual’s suitability for access to SGI. submit information relevant to the Records Checks of Individuals When a 7. The licensee shall document the individual’s trustworthiness and Reviewing Official Is Determining basis for its determination whether to reliability. The NRC Facilities Security Access to Safeguards Information grant access to SGI. Branch Chief shall, in writing, notify the General Requirements B. The licensee shall notify the NRC individual of this opportunity, and any of any desired change in reviewing Licensees and other persons who are deadlines for submitting this officials, in compliance with C.2 of the required to conduct fingerprinting shall information. The NRC Facilities subject Order. The NRC will determine comply with the requirements of this Security Branch Chief may make a whether the individual nominated as attachment.2 determination of access to SGI only the new reviewing official may have upon receipt of the additional A. 1. Each licensee subject to the provisions of this attachment shall access to SGI based on a previously- information submitted by the obtained or new criminal history check individual, or, if no such information is fingerprint each individual who is seeking or permitted access to and, therefore, will be permitted to submitted, when the deadline to submit serve as the licensee’s reviewing official. such information has passed. Safeguards Information (SGI). The licensee shall review and use the Prohibitions 6. Procedures To Notify an Individual of information received from the Federal A licensee shall not base a final the NRC Facilities Security Branch Chief Bureau of Investigation (FBI) and ensure determination to deny an individual Determination To Deny or Revoke that the provisions contained in the access to SGI solely on the basis of Access to SGI subject Order and this attachment are information received from the FBI a. Upon a determination by the NRC satisfied. involving: An arrest more than one (1) 2. The licensee shall notify each Facilities Security Branch Chief that an year old for which there is no affected individual that the fingerprints individual nominated as a reviewing information of the disposition of the will be used to secure a review of his/ official is denied or revoked access to case, or an arrest that resulted in her criminal history record and inform SGI, the individual shall be provided a dismissal of the charge or an acquittal. written explanation of the basis for this the individual of the procedures for A licensee shall not use information determination. revising the record or including an received from a criminal history check explanation in the record, as specified obtained pursuant to this Order in a 7. Procedures To Appeal an NRC in the ‘‘Right to Correct and Complete Determination To Deny or Revoke manner that would infringe upon the Information’’ section of this attachment. rights of any individual under the First Access to SGI 3. Fingerprints need not be taken if an Amendment to the Constitution of the employed individual (e.g., a licensee a. Upon a determination by the NRC United States, nor shall the licensee use employee, contractor, manufacturer, or Facilities Security Branch Chief that an the information in any way which supplier) is relieved from the individual nominated as a reviewing would discriminate among individuals fingerprinting requirement by 10 CFR official is denied or revoked access to on the basis of race, religion, national 73.59, has a favorably-decided U.S. SGI, the individual shall be afforded an origin, sex, or age. opportunity to appeal this Government criminal history records determination to the Director, Division check within the last five (5) years, or Procedures for Processing Fingerprint of Facilities and Security. The has an active federal security clearance. Checks determination must be appealed within Written confirmation from the Agency/ For the purpose of complying with twenty (20) days of receipt of the employer which granted the federal this Order, licensees shall, using an written notice of the determination by appropriate method listed in 10 CFR 2 As used herein, ‘‘licensee’’ means any licensee the Facilities Security Branch Chief, and or other person who is required to conduct 73.4, submit to the NRC’s Division of may either be in writing or in person. fingerprinting in accordance with these Facilities and Security, Mail Stop T– Any appeal made in person shall take requirements. 6E46, one completed, legible standard

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fingerprint card (Form FD–258, Right To Correct and Complete 2. The licensee may not disclose the ORIMDNRCOOOZ) or, where Information record or personal information collected practicable, other fingerprint records for and maintained to persons other than each individual seeking access to SGI, to Prior to any final adverse the subject individual, his/her the Director of the Division of Facilities determination, the licensee shall make representative, or to those who have a and Security, marked for the attention of available to the individual the contents need to access the information in the Division’s Criminal History Check of any criminal records obtained from performing assigned duties in the Section. Copies of these forms may be the FBI for the purpose of assuring process of determining access to obtained by writing the Office of correct and complete information. Safeguards Information. No individual Information Services, U.S. Nuclear Written confirmation by the individual authorized to have access to the Regulatory Commission, Washington, of receipt of this notification must be information may re-disseminate the DC 20555–0001, by calling (301) 415– maintained by the licensee for a period information to any other individual who 5877, or by e-mail to [email protected]. of one (1) year from the date of the does not have a need-to-know. Practicable alternative formats are set notification. 3. The personal information obtained forth in 10 CFR 73.4. The licensee shall If, after reviewing the record, an on an individual from a criminal history establish procedures to ensure that the individual believes that it is incorrect or record check may be transferred to quality of the fingerprints taken results incomplete in any respect and wishes to another licensee if the licensee holding in minimizing the rejection rate of change, correct, or update the alleged the criminal history record check fingerprint cards due to illegible or deficiency, or to explain any matter in receives the individual’s written request to re-disseminate the information incomplete cards. the record, the individual may initiate challenge procedures. These procedures contained in his/her file, and the The NRC will review submitted include either direct application by the current licensee verifies information fingerprint cards for completeness. Any individual challenging the record to the such as the individual’s name, date of Form FD–258 fingerprint record agency (i.e., law enforcement agency) birth, social security number, sex, and containing omissions or evident errors that contributed the questioned other applicable physical characteristics will be returned to the licensee for information, or direct challenge as to the for identification purposes. corrections. The fee for processing accuracy or completeness of any entry 4. The licensee shall make criminal fingerprint checks includes one re- on the criminal history record to the history records, obtained under this submission if the initial submission is Assistant Director, Federal Bureau of section, available for examination by an returned by the FBI because the Investigation, Identification Division, authorized representative of the NRC to fingerprint impressions cannot be Washington, DC 20537–9700 (as set determine compliance with the classified. The one free re-submission forth in 28 CFR 16.30 through 16.34). In regulations and laws. 5. The licensee shall retain all must have the FBI Transaction Control the latter case, the FBI forwards the fingerprint and criminal history records Number reflected on the re-submission. challenge to the agency that submitted received from the FBI, or a copy if the If additional submissions are necessary, the data and requests that agency to individual’s file has been transferred, they will be treated as initial submittals verify or correct the challenged entry. for three (3) years after termination of and will require a second payment of Upon receipt of an official employment or determination of access the processing fee. communication directly from the agency to SGI (whether access was approved or Fees for processing fingerprint checks that contributed the original denied). After the required three (3) year are due upon application. Licensees information, the FBI Identification period, these documents shall be shall submit payment with the Division makes any changes necessary destroyed by a method that will prevent application for processing fingerprints in accordance with the information reconstruction of the information in by corporate check, certified check, supplied by that agency. The licensee whole or in part. cashier’s check, money order, or must provide at least ten (10) days for electronic payment, made payable to an individual to initiate an action [FR Doc. E7–18564 Filed 9–19–07; 8:45 am] ‘‘U.S. NRC.’’ [For guidance on making challenging the results of an FBI BILLING CODE 7590–01–P electronic payments, contact the criminal history records check after the Facilities Security Branch, Division of record is made available for his/her Facilities and Security, at (301) 415– review. The licensee may make a final NUCLEAR REGULATORY 7404]. Combined payment for multiple SGI access determination based upon COMMISSION applications is acceptable. The the criminal history record only upon [Docket No. 070–00348] application fee (currently $27) is the receipt of the FBI’s ultimate sum of the user fee charged by the FBI confirmation or correction of the record. Notice of Availability of Environmental for each fingerprint card or other Upon a final adverse determination on Assessment and Finding of No fingerprint record submitted by the NRC access to SGI, the licensee shall provide Significant Impact for License on behalf of a licensee, and an NRC the individual its documented basis for Amendment to Special Nuclear processing fee, which covers denial. Access to SGI shall not be Materials License No. SNM–348, for administrative costs associated with granted to an individual during the Termination of the License and NRC handling of licensee fingerprint review process. Unrestricted Release of the submissions. The Commission will Department of the Army’s Facility in Protection of Information directly notify licensees who are subject Adelphi, MD to this regulation of any fee changes. 1. Each licensee who obtains a AGENCY: Nuclear Regulatory The Commission will forward to the criminal history record on an individual Commission. submitting licensee all data received pursuant to this Order shall establish ACTION: Issuance of Environmental from the FBI as a result of the licensee’s and maintain a system of files and Assessment and Finding of No application(s) for criminal history procedures for protecting the record and Significant Impact for License records checks, including the FBI the personal information from Amendment. fingerprint record. unauthorized disclosure.

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FOR FURTHER INFORMATION CONTACT: survey and decontamination of the Achievable (ALARA) requirement of 10 Steve Hammann, Health Physicist, Facility. Based on the Licensee’s CFR 20.1402. The NRC thus finds that Commercial and R&D Branch, Division historical knowledge of the site and the the Licensee’s final status survey results of Nuclear Materials Safety, Region I, conditions of the Facility, the Licensee are acceptable. King of Prussia, Pennsylvania, 19406; determined that only routine Based on its review, the staff has telephone 610–337–5399; fax number decontamination activities, in determined that the affected 610–337–5269; or by e-mail: accordance with their NRC-approved, environment and any environmental [email protected]. operating radiation safety procedures, impacts associated with the proposed SUPPLEMENTARY INFORMATION: were required. The Licensee was not action are bounded by the impacts required to submit a decommissioning evaluated by the ‘‘Generic I. Introduction plan to the NRC because worker cleanup Environmental Impact Statement in The U.S. Nuclear Regulatory activities and procedures are consistent Support of Rulemaking on Radiological Commission (NRC) is considering the with those approved for routine Criteria for License Termination of NRC- issuance of a license amendment to operations. The Licensee conducted Licensed Nuclear Facilities’’ (NUREG– Special Nuclear Materials License No. surveys of the Facility and provided 1496) Volumes 1–3 (ML042310492, SNM–348. This license is held by information to the NRC to demonstrate ML042320379, and ML042330385). The Department of the Army, U.S. Army that it meets the criteria in Subpart E of staff finds there were no significant Research Center, Adelphi Laboratory 10 CFR Part 20 for unrestricted release environmental impacts from the use of Center (the Licensee), for its Harry and for license termination. radioactive material at the Facility. The Diamond Laboratories (the Facility), Need for the Proposed Action NRC staff reviewed the docket file located at 2800 Powder Mill Road in records and the final status survey The Licensee has ceased conducting Adelphi, Maryland. Issuance of the report to identify any non-radiological licensed activities at the Facility, and amendment would authorize release of hazards that may have impacted the seeks the unrestricted use of its Facility the Facility for unrestricted use and environment surrounding the Facility. and the termination of its NRC materials termination of the NRC license. The No such hazards or impacts to the license. Licensee requested this action in a letter environment were identified. The NRC dated February 20, 2007. The NRC has Environmental Impacts of the Proposed has identified no other radiological or prepared an Environmental Assessment Action non-radiological activities in the area (EA) in support of this proposed action The historical review of licensed that could result in cumulative in accordance with the requirements of activities conducted at the Facility environmental impacts. Title 10, Code of Federal Regulations shows that such activities involved use The NRC staff finds that the proposed (CFR), Part 51 (10 CFR Part 51). Based of various radionuclides with half-lives release of the Facility for unrestricted on the EA, the NRC has concluded that greater than 120 days. Prior to use and the termination of the NRC a Finding of No Significant Impact performing the final status survey, the materials license is in compliance with (FONSI) is appropriate with respect to Licensee conducted decontamination 10 CFR 20.1402. Based on its review, the proposed action. The amendment activities, as necessary, in the areas of the staff considered the impact of the will be issued to the Licensee following the Facility affected by these residual radioactivity at the Facility and the publication of this FONSI and EA in radionuclides. concluded that the proposed action will the Federal Register. The Licensee completed a final status not have a significant effect on the II. Environmental Assessment survey on February 26, 2007. This quality of the human environment. survey covered the radiation storage Environmental Impacts of the Identification of Proposed Action area/decontamination shower and the Alternatives to the Proposed Action The proposed action would approve four thousand gallon underground the Licensee’s February 20, 2007 license storage tank. The final status survey Due to the largely administrative amendment request, resulting in release report was attached to the Licensee’s nature of the proposed action, its of the Facility for unrestricted use and amendment request dated February 20, environmental impacts are small. the termination of its NRC materials 2007. The Licensee elected to Therefore, the only alternative the staff license. License No. SNM–348 was demonstrate compliance with the considered is the no-action alternative, issued on February 3, 1960, pursuant to radiological criteria for unrestricted under which the staff would leave 10 CFR Part 70, and has been amended release as specified in 10 CFR 20.1402 things as they are by simply denying the periodically since that time. The by using the screening approach amendment request. This no-action licensee moved from its original described in NUREG–1757, alternative is not feasible because it location into the Facility in 1977. This ‘‘Consolidated NMSS Decommissioning conflicts with 10 CFR 70.38(d), license authorized the Licensee to use Guidance,’’ Volume 2. The Licensee requiring that decommissioning of special nuclear material for purposes of used the radionuclide-specific derived special nuclear material facilities be storage only. concentration guideline levels (DCGLs), completed and approved by the NRC The Facility is situated on developed there by the NRC, which after licensed activities cease. The approximately 160 acres of land. The comply with the dose criterion in 10 NRC’s analysis of the Licensee’s final building is 6000 square feet and consists CFR 20.1402. These DCGLs define the status survey data confirmed that the of office space and laboratories. The maximum amount of residual Facility meets the requirements of 10 Facility is located in a mixed radioactivity on building surfaces, CFR 20.1402 for unrestricted release and residential/commercial area. Within the equipment, and materials, and in soils, for license termination. Additionally, Facility, use of licensed materials was that will satisfy the NRC requirements denying the amendment request would confined to a 310 square foot radiation in Subpart E of 10 CFR Part 20 for result in no change in current storage area and a 40 square foot unrestricted release. The Licensee’s environmental impacts. The attached decontamination shower. final status survey results were below environmental impacts of the proposed On January 27, 2005, the Licensee these DCGLs and are in compliance action and the no-action alternative are ceased licensed activities and initiated a with the As Low As Reasonably therefore similar, and the no-action

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alternative is accordingly not further ‘‘Radiological Criteria for License U.S. Small Business Administration, considered. Termination;’’ 409 3rd Street SW., Suite 6050, 3. Title 10, Code of Federal Washington, DC 20416. Conclusion Regulations, Part 51, ‘‘Environmental SUPPLEMENTARY INFORMATION: Notice is The NRC staff has concluded that the Protection Regulations for Domestic hereby given that as a result of the proposed action is consistent with the Licensing and Related Regulatory President’s major disaster declaration on NRC’s unrestricted release criteria Functions;’’ 09/13/2007, applications for disaster specified in 10 CFR 20.1402. Because 4. NUREG–1496, ‘‘Generic loans may be filed at the address listed the proposed action will not Environmental Impact Statement in above or other locally announced significantly impact the quality of the Support of Rulemaking on Radiological locations. human environment, the NRC staff Criteria for License Termination of NRC- The following areas have been concludes that the proposed action is Licensed Nuclear Facilities;’’ determined to be adversely affected by the preferred alternative. 5. Notification Letter dated February the disaster: Agencies and Persons Consulted 28, 2005 [ML051080172]; Primary Counties (Physical Damage and 6. Termination Request and Final Economic Injury Loans): Grand NRC provided a draft of this Status Survey [ML070660139]. Environmental Assessment to the Forks. If you do not have access to ADAMS, Contiguous Counties (Economic Injury Maryland Department of Environmental or if there are problems in accessing the Protection for review on June 12, 2007. Loans Only): North Dakota. documents located in ADAMS, contact Nelson, Steele, Traill, Walsh. On June 13, 2007, Maryland Department the NRC Public Document Room (PDR) of the Environment responded by e- Minnesota. Reference staff at 1–800–397–4209, 301– Marshall, POLK. mail. The State agreed with the 415–4737, or by e-mail to [email protected]. conclusions of the EA, and otherwise The Interest Rates are: These documents may also be viewed For Physical Disasters: had no comments. electronically on the public computers The NRC staff has determined that the located at the NRC’s PDR, O 1 F21, One Percent proposed action is of a procedural White Flint North, 11555 Rockville nature, and will not affect listed species Pike, Rockville, MD 20852. The PDR Homeowners With Credit Avail- or critical habitat. Therefore, no further reproduction contractor will copy able Elsewhere ...... 6.250 consultation is required under Section 7 documents for a fee. Homeowners Without Credit of the Endangered Species Act. The Available Elsewhere ...... 3.125 NRC staff has also determined that the Dated at King of Prussia, Pennsylvania this Businesses With Credit Available proposed action is not the type of 13th day of September. Elsewhere ...... 8.000 activity that has the potential to cause For The Nuclear Regulatory Commission. Other (Including Non-Profit Orga- effects on historic properties. Therefore, James P. Dwyer, nizations) With Credit Available no further consultation is required Chief, Commercial and R&D Branch, Division Elsewhere ...... 5.250 of Nuclear Materials Safety, Region I. Businesses And Non-Profit Orga- under Section 106 of the National nizations Without Credit Avail- Historic Preservation Act. [FR Doc. E7–18587 Filed 9–19–07; 8:45 am] able Elsewhere ...... 4.000 BILLING CODE 7590–01–P III. Finding of No Significant Impact For Economic Injury: The NRC staff has prepared this EA in Businesses & Small Agricultural support of the proposed action. On the SMALL BUSINESS ADMINISTRATION Cooperatives Without Credit Available basis of this EA, the NRC finds that [Disaster Declaration #11035 and #11036] Elsewhere: 4.000. there are no significant environmental The number assigned to this disaster impacts from the proposed action, and North Dakota Disaster #ND–00009 for physical damage is 11035B and for that preparation of an environmental economic injury is 110360. impact statement is not warranted. AGENCY: U.S. Small Business (Catalog of Federal Domestic Assistance Accordingly, the NRC has determined Administration. that a Finding of No Significant Impact Numbers 59002 and 59008) ACTION: Notice. is appropriate. James E. Rivera, IV. Further Information SUMMARY: This is a Notice of the Deputy Associate Administrator for Disaster Presidential declaration of a major Assistance. Documents related to this action, disaster for the State of North Dakota [FR Doc. E7–18581 Filed 9–19–07; 8:45 am] including the application for license (FEMA–1726–DR), dated 09/13/2007. BILLING CODE 8025–01–P amendment and supporting Incident: Severe Storms and Tornado. documentation, are available Incident Period: 08/26/2007 through electronically at the NRC’s Electronic 08/27/2007. SOCIAL SECURITY ADMINISTRATION Reading Room at http://www.nrc.gov/ DATES: Effective Date: 09/13/2007. reading-rm/adams.html. From this site, Physical Loan Application Deadline Agency Information Collection you can access the NRC’s Agencywide Date: 11/13/2007. Activities: Proposed Request and Document Access and Management Economic Injury (EIDL) Loan Comment Request System (ADAMS), which provides text Application Deadline Date: 06/13/2008. and image files of NRC’s public The Social Security Administration documents. The documents related to ADDRESSES: Submit completed loan (SSA) publishes a list of information this action are listed below, along with applications to: U.S. Small Business collection packages that will require their ADAMS accession numbers. Administration, Processing And clearance by the Office of Management 1. NUREG–1757, ‘‘Consolidated Disbursement Center, 14925 Kingsport and Budget (OMB) in compliance with NMSS Decommissioning Guidance;’’ Road, Fort Worth, TX 76155. Public Law 104–13, the Paperwork 2. Title 10 Code of Federal FOR FURTHER INFORMATION CONTACT: A. Reduction Act of 1995, effective October Regulations, Part 20, Subpart E, Escobar, Office of Disaster Assistance, 1, 1995. The information collection

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packages that may be included in this publication. You can obtain copies of Patient Self-Administered or Staff notice are for new information the collection instruments by calling the Administered Care—0960–NEW. SSA collections, approval of existing SSA Reports Clearance Officer at 410– operates Employee Health Clinics on- information collections, revisions to 965–0454 or by writing to the address site in eight different states. These OMB-approved information collections, listed above. clinics provide health care for all SSA and extensions (no change) of OMB- 1. Request for Waiver of Special employees including treatments of approved information collections. Veterans Benefits (SVB) Overpayment personal medical conditions when SSA is soliciting comments on the Recovery or Change in Repayment authorized through a physician. The accuracy of the agency’s burden Rate—20 CFR 408.900–408.950, SSA–5072 is the employee’s personal estimate; the need for the information; 408.923(b), 408.931(b), 408.932(c), (d) physician’s order form. The information its practical utility; ways to enhance its and (e), 408.941(b) and 408.942—0960– collected on the SSA–5072 gives the quality, utility, and clarity; and on ways 0698. Title VIII allows the payment of nurses the guidance they need by law to to minimize burden on respondents, a monthly benefit by the Commissioner perform certain medical procedures and including the use of automated of Social Security to a qualified World to administer prescription medications collection techniques or other forms of War II veteran who resides outside the such as allergy immunotherapy. Also, information technology. Written United States. When an overpayment in the information collected by the SSA– comments and recommendations SVB occurs, the beneficiary can use this regarding the information collection(s) 5072 allows the SSA Medical Officer to form to request waiver of recovery of the determine whether the treatment can be should be submitted to the OMB Desk overpayment or a change in the Officer and the SSA Reports Clearance administered safely and appropriately repayment rate. The SSA–2032–BK will in the SSA Employee Health Units. Officer. The information can be mailed, be used to obtain the information faxed or emailed to the individuals at necessary to determine whether the Each state has a Nurse Practice Act the addresses and fax numbers listed provisions of the Act regarding waiver governing the practice of registered below: of recovery of the overpayment are met. nurses in the state. All Nurse Practice (OMB), Office of Management and The information on the form is needed Acts require that registered nurses Budget, Attn: Desk Officer for SSA, to determine a repayment rate if administer prescription medications Fax: 202–395–6974, E-mail address: repayment cannot be waived. and certain medical treatments by [email protected]. Respondents are beneficiaries who have following a licensed physician’s orders. (SSA), Social Security Administration, overpayments on their Title VIII record Form SSA–5072 provides the vehicle for DCBFM, Attn: Reports Clearance and wish to file a claim for waiver of the physician to provide these orders to Officer, 1333 Annex Building, 6401 recovery or change in repayment rate. the SSA nursing staff. Respondents are Security Blvd., Baltimore, MD 21235, Type of Request: Extension of an physicians of SSA employees who need Fax: 410–965–6400, E-mail address: OMB-approved information collection. to have medical treatment in the SSA [email protected]. Number of Respondents: 39. Employee Health Unit. I. The information collections listed Frequency of Response: 1. Type of Request: Information below are pending at SSA and will be Average Burden Per Response: 120 Collection in Use without an OMB submitted to OMB within 60 days from minutes. Number. the date of this notice. Therefore, your Estimated Annual Burden: 78 hours. comments should be submitted to SSA 2. Request for Medical Treatment in Number of Responses: 175. within 60 days from the date of this an SSA Employee Health Facility: Estimated Annual Burden: 15 hours.

Average burden Estimated Medication dosage changes Number of Frequency of Number of per response annual burden respondents response responses (minutes) (hours)

Annually ...... 25 1 25 5 2 Bi-Annually ...... 75 2 150 5 13

Totals ...... 100 ...... 175 ...... 15

3. Disability Hearing Officer’s Report Number of Respondents: 2,000. physicians, hospital directors, medical of Disability Hearing (DC)—20 CFR Frequency of Response: 1. records librarians, and other medical 416.1407—0906–0507. The information Average Burden per Response: 60 personnel. collected on form SSA–1204–BK is used minutes. Type of Request: Revision of an OMB- by the Disability Hearing Officer (DHO) Estimated Annual Burden: 2000 approved information collection to conduct and document disability hours. Number of Respondents: 12,000. hearings, and to provide a structured 4. Medical Report (Individual with Frequency of Response: 1. format that covers all conceivable issues Childhood Impairment)—20 CFR Average Burden per Response: 30 relating to Supplemental Security 404.1512–404.1515, 416.912–416.915, & minutes. Income (SSI) claims for disabled 20 CFR 422.125—0960–0102. The Estimated Annual Burden: 6,000 children. The completed SSA–1204–BK information collected from SSA–3827 is hours. will aid the DHO in preparing the used by SSA to determine the childhood II. The information collections listed disability decision and will provide a claimant’s physical status prior to below have been submitted to OMB for record of what transpired in the hearing. making a disability determination and clearance. Your comments on the The respondents are DHO’s in the State to document the childhood disability information collections would be most Disability Determination Services. claims folder with the medical useful if received by OMB and SSA Type of Request: Extension of an evidence. The respondents are members within 30 days from the date of this OMB-approved information collection. of the medical community, and include publication. You can obtain a copy of

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the OMB clearance packages by calling Dated: September 14, 2007. Intended effective date: 1 October the SSA Reports Clearance Officer at Elizabeth A. Davidson, 2007. 410–965–0454 or by writing to the Reports Clearance Officer, Social Security Renee V. Wright, address listed above. Administration. Program Manager, Docket Operations, 1. National 800 Number—Claims [FR Doc. E7–18538 Filed 9–19–07; 8:45 am] Federal Register Liaison. Status—20 CFR 401.45–0960–NEW. BILLING CODE 4191–02–P [FR Doc. E7–18570 Filed 9–19–07; 8:45 am] SSA has established a process for BILLING CODE 4910–9X–P authenticating the information of individuals who use the automated telephone services or speak to an agent DEPARTMENT OF TRANSPORTATION DEPARTMENT OF TRANSPORTATION to request information from SSA records. Prior to SSA responding to Office of the Secretary Office of the Secretary requests for personal information through the automated telephone Aviation Proceedings, Agreements Aviation Proceedings, Agreements services, we must authenticate the Filed the Week Ending August 31, 2007 Filed the Week Ending August 3, 2007 requester’s information by obtaining the The following Agreements were filed The following Agreements were filed appropriate identification elements. with the Department of Transportation with the Department of Transportation This automated telephone service will under the sections 412 and 414 of the under the sections 412 and 414 of the provide callers with status of a Social Federal Aviation Act, as amended (49 Federal Aviation Act, as amended (49 Security claim which they have filed. U.S.C. 1383 and 1384) and procedures U.S.C. 1383 and 1384) and procedures All information provided will then be governing proceedings to enforce these governing proceedings to enforce these compared to the information contained provisions. Answers may be filed within provisions. Answers may be filed within in our records so that the appropriate 21 days after the filing of the 21 days after the filing of the claim is accessed and the respondent is application. application. given the status of that claim. Docket Number: OST–2007–28877. Respondents are current Social Security Docket Number: OST–2007–29149. Date Filed: July 30, 2007. beneficiaries. Date Filed: August 31, 2007. Parties: Members of the International Type of Request: Request for a new Parties: Members of the International Air Transport Association. information collection. Air Transport Association. Subject: TC2 Within Middle East. Expedited Resolutions and Specified Number of Respondents: 704,422. Subject: Resolution 015h. USA Add- Fares Tables. Frequency of Response: 1. ons between USA and UK, (Memo Intended effective date: 15 August 0215). Average Burden per Response: 1 2007. minute. Intended effective date: 1 October Docket Number: OST–2007–28878. 2007. Estimated Annual Burden: 11,740 Date Filed: July 30, 2007. hours. Renee V. Wright, Parties: Members of the International Air Transport Association. 2. Missing and Discrepant Wage Program Manager, Docket Operations, Subject: TC2 Within Middle East. Federal Register Liaison. Reports Letter and Questionnaire—26 Resolutions and Specified Fares Tables. CFR 31.6051–2–0960—0432. Each year [FR Doc. E7–18565 Filed 9–19–07; 8:45 am] Intended effective date: 15 August employers report the wage amounts they BILLING CODE 4910–9X–P 2007. paid their employees to the Internal Docket Number: OST–2007–28879. Revenue Service (IRS) for tax purposes, DEPARTMENT OF TRANSPORTATION Date Filed: July 30, 2007. and separately to SSA for retirement Parties: Members of the International and disability coverage purposes. These Office of the Secretary Air Transport Association, Subject: reported amounts should equal each Composite Passenger Tariff other; however, each year some of the Aviation Proceedings, Agreements Coordinating Conference. Expedited employer wage reports that SSA Filed the Week Ending August 17, 2007 Composite Resolution 049a. receives are less than the wage amounts Intended effective date: 15 September reported to the IRS. SSA attempts to The following Agreements were filed 2007. ensure that employees receive full credit with the Department of Transportation Docket Number: OST–2007–28880. for the wages that they have earned under the sections 412 and 414 of the Date Filed: July 30, 2007. through the use of the forms SSA–L93– Federal Aviation Act, as amended (49 Parties: Members of the International SM; SSA–L94–SM; SSA–95–SM and U.S.C. 1383 and 1384) and procedures Air Transport Association. SSA–97–SM. Respondents are governing proceedings to enforce these Subject: Composite Passenger Tariff employers who reported less wage provisions. Answers may be filed within Coordinating Conference. Expedited amounts to SSA than they reported to 21 days after the filing of the Composite Resolutions. the IRS. application. Intended effective date: 1 November Type of Request: Revision of an OMB- Docket Number: OST–2007–29051. 2007. approved information collection. Date Filed: August 17, 2007. Docket Number: OST–2006–26409. Number of Respondents: 360,000. Date Filed: August 2, 2007. Parties: Members of the International Frequency of Response: 1. Parties: Members of the International Air Transport Association. Air Transport Association. Average Burden per Response: 30 Subject: Mail Vote 547 Adoption— Subject: TC23 Europe-South Asian minutes. Resolutions TC31 South Pacific (except Subcontinent. Expedited Flex Fares Estimated Annual Burden: 180,000 between South West Pacific and Package. Bangkok, 13 July 2007. Memo hours. Canada, USA). 0158, 2 August 2007.

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Intended effective date: 1 November Intended effective date: 1 January 2008. FL. (ii) The Charter air transportation of 2007. Docket Number: OST–2007–28998. property and mail between any point or Docket Number: OST–2007–28938. Date Filed: August 9, 2007. points in the Russian Federation and Date Filed: August 3, 2007. Parties: Members of the International any point or points in the territory of the Parties: Members of the International Air Transport Association. United States; and to engage in such Air Transport Association. Subject: other charter services. (iii) To engage in Subject: TC23 Europe-South Asian Mail Vote Number A 137 such other charter trips in foreign air Subcontinent. Expedited Composite Implementation of Resolution 814 in transportation. Applicant further Resolutions. Ukraine. requests that it be authorized to operate Intended effective date: 1 November Intended effective date: 1 April 2007. under the name and style of ‘‘CJSC Aviation Enterprise Tesis’’ and/or 2007. Docket Number: OST–2007–28999. Docket Number: OST–2007–28939. Date Filed: August 10, 2007. ‘‘Aviation Enterprise Tesis’’ or ‘‘Tesis Date Filed: August 3, 2007. Parties: Members of the International Airlines.’’ Parties: Members of the International Air Transport Association. Renee V. Wright, Air Transport Association. Subject: Program Manager, Docket Operations, Subject: TC23 Europe-South Asian Mail Vote Number A 138 Resolution 832 Federal Register Liaison. Subcontinent. Expedited Resolution Remittance in Canada. [FR Doc. E7–18563 Filed 9–20–07; 8:45 am] 250o. Intended effective date: 1 April 2007. BILLING CODE 4910–9X–P Intended effective date: 1 November 2007. Renee V. Wright, Program Manager, Docket Operations, DEPARTMENT OF TRANSPORTATION Renee V. Wright, Federal Register Liaison. Program Manager, Docket Operations, [FR Doc. E7–18578 Filed 9–19–07; 8:45 am] Office of the Secretary Federal Register Liaison. BILLING CODE 4910–9X–P [FR Doc. E7–18576 Filed 9–19 –07; 8:45 am] Notice of Applications for Certificates BILLING CODE 4910–9X–P of Public Convenience and Necessity DEPARTMENT OF TRANSPORTATION and Foreign Air Carrier Permits Filed Under Subpart B (Formerly Subpart Q) DEPARTMENT OF TRANSPORTATION Office of the Secretary During the Week Ending August 10, 2007 Office of the Secretary Notice of Applications for Certificates of Public Convenience and Necessity The following Applications for Aviation Proceedings, Agreements and Foreign Air Carrier Permits Filed Certificates of Public Convenience and Filed the Week Ending August 10, 2007 Under Subpart B (Formerly Subpart Q) Necessity and Foreign Air Carrier During the Week Ending August 24, Permits were filed under Subpart B The following Agreements were filed 2007 (formerly Subpart Q) of the Department with the Department of Transportation of Transportation’s Procedural under the Sections 412 and 414 of the The following Applications for Regulations (See 14 CFR 301.201 et Federal Aviation Act, as amended (49 Certificates of Public Convenience and seq.). The due date for Answers, U.S.C. 1383 and 1384) and procedures Necessity and Foreign Air Carrier Conforming Applications, or Motions to governing proceedings to enforce these Permits were filed under Subpart B Modify Scope are set forth below for provisions. Answers may be filed within (formerly Subpart Q) of the Department each application. Following the Answer 21 days after the filing of the of Transportation’s Procedural period DOT may process the application application. Regulations (See 14 CFR 301.201 et by expedited procedures. Such Docket Number: OST–2007–28984. seq.). The due date for Answers, procedures may consist of the adoption Date Filed: August 9, 2007. Conforming Applications, or Motions to of a show-cause order, a tentative order, Parties: Members of the International Modify Scope are set forth below for or in appropriate cases a final order Air Transport Association. each application. Following the answer without further proceedings. Subject: period DOT may process the application Docket Number: OST–2007–28950. Resolutions Adopted for Expedited by expedited procedures. Such Date Filed: August 6, 2007. Effectiveness, r.814, r.818, r.818g, and procedures may consist of the adoption Due Date for Answers, Conforming r.832. of a show-cause order, a tentative order, Applications, or Motion to Modify or in appropriate cases a final order Scope: August 27, 2007. Intended effective date: 1 September without further proceedings. Description: Application of Vietnam 2007 or 1 October 2007 as indicated. Docket Number: OST–2007–29081. Airlines Corporation (‘‘ Vietnam Docket Number: OST–2007–28986. Date Filed: August 21, 2007. Airlines’’), I. requesting an exemption to Date Filed: August 9, 2007. Due Date for Answers, Conforming conduct A. scheduled foreign air Parties: Members of the International Applications, or Motion to Modify transportation of persons, property, and Air Transport Association. Scope: September 11, 2007. mail from points behind Vietnam, via Subject: Description: Application of CJSC Vietnam, Japan and Taiwan, to the U.S. Finally Adopted Resolutions for Normal Aviation Enterprise Tesis, (‘‘Tesis’’), coterminal points Los Angeles, San Effectiveness: r.03, r.800, r.800a, requesting a foreign air carrier permit Francisco, New York, Seattle and r.800b, r.800c, r.800e, r.800t, r.804, authorizing (i) The carriage in Dallas/Ft.Worth, and beyond to points r.808, r.810, r.810c, r.810i, r.810j, scheduled foreign air transportation of in Canada; and B. charter foreign air r.810r, r.814, r.814ff, r.814hh, r.814pp, property and mail on three following transportation of persons, property, and r.816, r.818, r.818a, r.820e, r.822, routes: (a) Khabarovsk, Russia- mail (1) Between any point or points in r.824r, r.832, r.850, r.850a, r.850c, Anchorage, AK-New York, NY-Miami, Vietnam and any point or points in the r.850m, r.850p, r.854, r.856, r.860a, FL (b) Moscow, Russia-via Shannon/ United States, (2) between any point or r.866, and r.890. Gander-New York, New York, Miami, points in the United States and any

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point or points in third country or Modify Scope are set forth below for or in appropriate cases a final order countries, provided that such service each application. Following the Answer without further proceedings. constitutes part of a continuous period DOT may process the application Docket Number: OST–2007–28724. operation, with or without a change of by expedited procedures. Such Date Filed: July 10, 2007. aircraft, that includes service to procedures may consist of the adoption Due Date for Answers, Conforming Vietnam, for the purpose of carrying of a show-cause order, a tentative order, Applications, or Motion to Modify traffic between Vietnam and the United or in appropriate cases a final order Scope: July 31, 2007. States, and (3) as otherwise authorized. without further proceedings. Description: Application of Air II) A foreign air carrier permit to Docket Number: OST–2007–28895. Molokai Nui, Inc., requesting authority conduct A. scheduled foreign air Date Filed: July 31, 2007. to operate scheduled passenger service transportation of persons, property, and Due Date for Answers, Conforming as a commuter air carrier. mail, from points behind Vietnam via Applications, or Motion to Modify Docket Number: OST–2007–28728. Vietnam and intermediate points to a Scope: August 21, 2007. Date Filed: July 10, 2007. point or points in the United States and Description: Application of Croatia Due Date for Answers, Conforming beyond, consistent with the Air Airlines, requesting a foreign air carrier Applications, or Motion to Modify Transport Agreement in effect between permit to engage in scheduled foreign Scope: July 31, 2007. the United States and Vietnam and the air transportation of persons, property, Description: Application of Alitalia points and countries selected by the and mail from points behind Croatia, via Linee Aeree Italiane S.p.A. (‘‘Alitalia’’), Government of Vietnam thereunder; and Croatia and any intermediate points, to requesting an amendment to its foreign (B) charter foreign air transportation of any point or points in the United States air carrier permit to the full extent persons, property, and mail (1) Between and beyond. authorized by the new Air Transport any point or points in Vietnam an any Docket Number: OST–2007–28919. Agreement between the United States, point or points in the United States, (2) Date Filed: August 2, 2007. on the one hand, and the European between any point or points in the Due Date for Answers, Conforming Union and the member states of the United States and any point or points in Applications, or Motion to Modify European Union, on the other hand a third country or countries, provided Scope: August 23, 2007. (‘‘U.S.–E.U. Agreement’’), to enable that such service constituents part of a Description: Application of Alitalia to engage in: (i) Foreign continuous operation, with or without a Aeroenlaces Nacionales, S.A. de C.V. scheduled and charter air transportation change of aircraft, that includes service (‘‘Vivaaerobus’’), requesting a foreign air of persons, property, and mail from any to Vietnam for the purpose of carrying carrier permit to engage in scheduled point or points behind any member state local traffic between Vietnam and the foreign air transport of persons, of the European Union via any point or United States, and (3) as otherwise property, and mail from a point or points in any member state and via authorized. intermediate points to any point or Docket Number: OST–2002–12358. points in Mexico to a point or points in the United States, as well as such points in the United States or beyond; Date Filed: August 7, 2007. (ii) foreign scheduled and charter air Due Date for Answers, Conforming charter authority permitted under the U.S.-Mexico Air Transport Agreement. transportation of persons, property, and Applications, or Motion to Modify mail between any point or points in the Scope: August 28, 2007. Renee V. Wright, United States and any point or points in Description: Application of M&N Program Manager, Docket Operations, any member of the European Common Aviation, Inc. requesting authority to Federal Register Liaison. Aviation Area; (iii) foreign scheduled resume scheduled passenger operation [FR Doc. E7–18569 Filed 9–19–07; 8:45 am] and charter cargo air transportation as a commuter air carrier. BILLING CODE 4910–9X–P between any point or points in the Renee V. Wright, United States and any other point or Program Manager, Docket Operations, points; (iv) other charters pursuant to Federal Register Liaison. DEPARTMENT OF TRANSPORTATION the prior approval requirements set [FR Doc. E7–18566 Filed 9–19–07; 8:45 am] forth in part 212; and (v) transportation Office of the Secretary BILLING CODE 4910–9X–P authorized by any additional route Notice of Applications for Certificates rights that may be made available to of Public Convenience and Necessity European Union carriers in the future. DEPARTMENT OF TRANSPORTATION and Foreign Air Carrier Permits Filed Alitalia also requests a corresponding exemption to the extent necessary to Office of the Secretary Under Subpart B (Formerly Subpart Q) During the Week Ending July 13, 2007 enable Alitalia to provide the services described above pending issuance of an Notice of Applications for Certificates amendment to its foreign air carrier of Public Convenience and Necessity The following Applications for permit and such other relief as the and Foreign Air Carrier Permits Filed Certificates of Public Convenience and Department may deem necessary or Under Subpart B (Formerly Subpart Q) Necessity and Foreign Air Carrier appropriate. During the Week Ending August 3, Permits were filed under Subpart B 2007 (formerly Subpart Q) of the Department Docket Number: OST–2006–24355. of Transportation’s Procedural Date Filed: July 12, 2007. The following Applications for Regulations (See 14 CFR 301.201 et. Due Date for Answers, Conforming Certificates of Public Convenience and seq.). The due date for Answers, Applications, or Motion to Modify Necessity and Foreign Air Carrier Conforming Applications, or Motions to Scope: August 2, 2007. Permits were filed under Subpart B Modify Scope are set forth below for Description: Application of Amira Air (formerly Subpart Q) of the Department each application. Following the Answer GmbH (‘‘Amira Air’’), requesting an of Transportation’s Procedural period DOT may process the application exemption and an amended foreign air Regulations (See 14 CFR 301.201 et by expedited procedures. Such carrier permit authorizing Amira Air to seq.). The due date for Answers, procedures may consist of the adoption conduct the following services using Conforming Applications, or Motions to of a show-cause order, a tentative order, small aircraft, in addition to the charter

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services authorized under its existing procedures may consist of the adoption countries; (4) other charter foreign air foreign air carrier permit: (i) Charter of a show-cause order, a tentative order, transportation of persons, property and foreign air transportation of persons, or in appropriate cases a final order mail; and (5) transportation authorized property, and mail from any point or without further proceedings. by any additional route or other rights points behind any Member State of the Docket Number: OST–2007–29028. made available to European Community European Union, via any point or points Date Filed: August 14, 2007. carriers in the future. in any EU Member State and via Due Date for Answers, Conforming Docket Number: OST–2007–29047. intermediate points, to any point or Applications, or Motion to Modify Date Filed: August 16, 2007. points in the United States and beyond; Scope: September 4, 2007. Due Date for Answers, Conforming (ii) charter foreign air transportation of Description: Application of Societe Applications, or Motion to Modify persons, property, and mail between Air France (‘‘Air France’’) requesting an Scope: September 6, 2007. any point or points in the United States exemption and an amended foreign air Description: Application of and any point or points in any member carrier permit authorizing Air France to Continental Airlines, Inc. of the European Common Aviation Area conduct operations to and from the (‘‘Continental’’), requesting a certificate (‘‘ECAA’’); (iii) other charters (between United States to the full extent of public convenience and necessity non-EU/ECAA third countries and the authorized by the recently-signed authorizing Continental to provide United States, and otherwise) in United States-European Union Air scheduled foreign air transportation of accordance with part 212; and (iv) Transport Agreement, for flight persons, property, and mail between charter transportation authorized by any operations on or after March 30, 2008, Houston, Texas and Buenos Aires, additional route rights made available to including authority to engage in: (i) Argentina. European Community carriers in the Foreign scheduled and charter air Renee V. Wright, future, to the extent permitted by Amira transportation of persons, property, and Air’s homeland license on file with the Program Manager, Docket Operations, mail from any point or points behind Federal Register Liaison. Department. any Member States of the European [FR Doc. E7–18585 Filed 9–19–07; 8:45 am] Docket Number: OST–2007–28736. Union, via any point or points in any Date Filed: July 12, 2007. Member State and via intermediate BILLING CODE 4910–9X–P Due Date for Answers, Conforming point or points in the United States and Applications, or Motion to Modify beyond; (ii) foreign scheduled and DEPARTMENT OF TRANSPORTATION Scope: August 2, 2007. charter air transportation of persons, Description: Application of Hi Fly— property and mail between any point or Federal Aviation Administration Transportes Aereos S.A., requesting an points in the United States and any initial foreign air carrier permit to point or points in any member of the Public Notice for Waiver of provide charter foreign air European Common Aviation Area; (iii) Aeronautical Land-Use Assurance; transportation of persons, property, and foreign scheduled and charter cargo air Pellston Regional Airport; Pellston, MI mail from points behind Portugal via transportation between any point or Portugal and intermediate points to a AGENCY: Federal Aviation points in the United States and any Administration, DOT. point or points in the United States and point or points; (iv) other charters ACTION: beyond. pursuant to 14 CFR Part 212; and (v) Notice of intent of waiver with respect to land. Renee V. Wright, transportation authorized by any Program Manager, Docket Operations, additional route rights made available to SUMMARY: The Federal Aviation Federal Register Liaison. European Community carriers in the Administration (FAA) is considering a [FR Doc. E7–18572 Filed 9–19–07; 8:45 am] future. proposal to change a portion of the BILLING CODE 4910–9X–P Docket Number: OST–2007–29037. airport from aeronautical use to non- Date Filed: August 15, 2007. aeronautical use and to authorize the Due Date for Answers, Conforming release of 621.46 acres of vacant airport DEPARTMENT OF TRANSPORTATION Applications, or Motion to Modify property for the proposed development Scope: September 5, 2007. of warehouses, training centers, and Office of the Secretary Description: Application of Deutsche associated access roads as a component Notice of Applications for Certificates Lufthansa AG (‘‘Lufthansa’’ ), requesting of Sovereign Deed’s National Response of Public Convenience and Necessity an amendment of its foreign air carrier Center. The land consists of 7 parcels. and Foreign Air Carrier Permits Filed permit and an exemption to engage in: Parcel 1 was acquired under grant 9–20– Under Subpart B (Formerly Subpart Q) (1) Scheduled and charter foreign air 048–C905. Parcels 2, 3, 4, 5 and 8 were During the Week Ending August 17, transportation of persons, property, and dedicated as airport property prior to 2007 mail from any point or points behind 1946 and have no federal funding any Member State(s) of the European involvement. Parcel 7 was acquired The following Applications for Union via any point or points in any under grants 9–2–048–C905 and 8–26– Certificates of Public Convenience and Member State(s) and via intermediate 0076–01. There are no impacts to the Necessity and Foreign Air Carrier points to any point or points in the airport by allowing the airport to lease Permits were filed under Subpart B United States and beyond; (2) scheduled the property. The land is not needed for (formerly Subpart Q) of the Department and charter foreign air transportation of aeronautical use. Approval does not of Transportation’s Procedural persons, property and mail between any constitute a commitment by the FAA to Regulations (See 14 CFR 301.201 et. point or points in the United States and financially assist in the lease of the seq.). The due date for Answers, any point or points in any member of subject airport property nor a Conforming Applications, or Motions to the European Common Aviation Area; determination of eligibility for grant-in- Modify Scope are set forth below for (3) scheduled and charter foreign cargo aid funding from the FAA. The each application. Following the Answer air transportation between any point or disposition of proceeds from the lease of period DOT may process the application points in the United States and any the airport property will be in by expedited procedures. Such point or points in any third country or accordance with FAA’s Policy and

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Procedures Concerning the Use of to the POINT OF BEGINNING; thence Parcel 4 Legal Description ° ′ ″ Airport Revenue, published in the continuing South 45 35 01 East Part of sections 28, 33, and 34 of ° ′ ″ Federal Register on February 16, 1999. 1234.50 feet; thence South 45 00 39 Township 37 North Range 4 West, In accordance with section 47107(h) of East parallel to and 745 feet McKinley Township, Emmet County, title 49, United States Code, this notice Southwesterly of the center line of Michigan, described as BEGINNING at is required to be published in the runway 14/32 2604.99 feet; thence the quarter corner common to sections Federal Register 30 days before South 45°00′13″ West parallel with and 33 and 34; thence North 89°53′55″ West modifying the land-use assurance that 495 feet Northwesterly of the center line 1273.16 feet; thence North 21°58′52″ requires the property to be used for an of runway 5/23 884.29 feet; thence East 318.93 feet; thence North 17°05′27″ aeronautical purpose. South 38°57′34″ West 406.35 feet; West 437.62 feet; thence North DATES: Comments must be received on thence South 45°24′14″ East 469.58 feet; 43°50′18″ West 1054.05 feet; thence or before October 22, 2007. thence South 43°08′52″ West 216.53 North 43°49′43″ West 1296.14 feet; ADDRESSES: Written comments on the feet; thence North 46°51′08″ West thence North 46°51′08″ West 548.82 Sponsor’s request must be delivered or 554.62 feet; thence North 56°53′28″ feet; thence North 43°08′52″ East 216.53 mailed to: Jason K. Watt, Program West 442.54 feet; thence North feet; thence South 45°24′14″ East 704.93 Manager, Detroit Airports District 41°08′01″ West 1012.07 feet; thence feet; thence North 63°12′29″ East 396.10 Office, 11677 South Wayne Road, Suite North 73°33′18″ West 571.29 feet to the feet; thence North 52°27′49″ East 776.25 107, Romulus, MI 48174. West section line of said section; thence feet; thence South 45°21′34″ East FOR FURTHER INFORMATION CONTACT: North 00°53′52″ West along said section 3984.18 feet; thence North 89°54′03″ Jason K. Watt, Program Manager, line 2589.85 feet to the POINT OF East 138.29 feet; thence South 44°26′16″ Federal Aviation Administration, Great BEGINNING. East 419.59 feet to the East & West Lakes Region, Detroit Airports District quarter line of section 34; thence South Being a part of section 28, Township Office, DET ADO–614, 11677 South 89°54′17″ West along the East & West 37 North Range 4 West and containing Wayne Road, Suite 107, Romulus, quarter line 1575.63 feet to the POINT Michigan 48174. Telephone Number 114.33 acres. Subject to easements and OF BEGINNING. (734–229–2906)/FAX Number (734– restrictions of record and subject to the Being a part of sections 28, 33 and 34, 229–2950). Documents reflecting this rights of the public and any Township 37 North Range 4 West and FAA action may be reviewed at this governmental unit in any part thereof containing 131.16 acres. Subject to same location or at Pellston Regional taken, used or deeded for street, road or easements and restrictions of record and Airport, Pellston, Michigan. highway purposes. subject to the rights of the public and SUPPLEMENTARY INFORMATION: Parcel 3 Legal Description any governmental unit in any part thereof taken, used or deeded for street, Parcel 1 Legal Description Part of section 33, Township 37 North road or highway purposes. Part of the Northeast quarter of Range 4 West, McKinley Township, Parcel 5 Legal Description Section 29, Township 37 North Range 4 Emmet County, Michigan, described as West, McKinley Township, Emmet BEGINNING at the Southwest corner of Part of the North half of section 28 County, Michigan, described as said section 33; thence North 00°17′05″ and part of the Northwest quarter of commencing at the Northeast corner of West along said section line 2653.81 feet section 27 of Township 37 North Range said section 29; thence South 00°53′52″ to the quarter corner common to 4 West, McKinley Township, Emmet East along said section line 907.19 feet sections 32 and 33; thence North County, Michigan, described as BEGINNING at the section corner to the POINT OF BEGINNING; thence 00°09′30″ East along said section line ° ′ ″ common to sections 21, 22, 27 and 28; continuing South 00 53 52 East along 2595.44 feet; thence South 89°50′30″ thence North 88°56′59″ East along the said section line 446.14 feet; thence East 75.51 feet; thence South 53°49′19″ ° ′ ″ section line common to sections 22 and North 89 47 53 West 1304.56 feet to the East 474.49 feet; thence South 76°52′38″ 27 1095.01 feet; thence South 51°04′47″ East eighth line of said section; thence East 406.85 feet; thence South 53°04′07″ North 00°34′44″ West along the East ° ′ ″ West 331.61 feet; thence South East 939.31 feet; thence South 32 44 38 45°00′13″ West parallel with and 495 eighth line 1353.20 feet to the North East 861.74 feet; thence South 45°25′48″ section line; thence South 89°47′53″ feet Northwest of the center line of East 1337.90 feet to the East and West runway 5/23 2676.25 feet; thence North East along said section line 198.44 feet; quarter line of said section; thence thence South 53°32′29″ East 925.61 feet; 45°00′38″ West parallel with and North 89°53′55″ West along said quarter thence South 45°35′01″ East 515.69 feet 1494.74 feet Northeasterly of the center line 386.56 feet to the center quarter to the POINT OF BEGINNING. line of runway 14/32 2900.31 feet to the corner of said section; thence South section line common to sections 21 and Being a part of the Northeast quarter ° ′ ″ of Section 39, Township 37 North Range 00 17 11 West 1319.66 feet the South 28; thence North 89°24′26″ East along eighth line of said section; thence South said section line 417.95 feet to the 4 West and containing 29.73 acres. ° ′ ″ Subject to easements and restrictions of 89 56 39 West along the South eighth quarter corner common to sections 21 line 1316.11 feet; thence South and 28; thence South 81°47′10″ East record and subject to the rights of the ° ′ ″ public and any governmental unit in 00 00 00 West 1323.7 feet to the South 648.03 feet; thence North 81°28′10″ East any part thereof taken, used or deeded section line of said section; thence 710.97 feet to the section line common ° ′ ″ for street, road or highway purposes. South 89 47 08 West 1309.53 feet to the to sections 21 and 28; thence North POINT OF BEGINNING. Being a part of 89°27′04″ East 1344.55 feet to the Parcel 2 Legal Description section 33, Township 37 North Range 4 POINT OF BEGINNING. Part of section 28, Township 37 North West and containing 224.69 acres. Being a part of the North half of Range 4 West, McKinley Township, Subject to easements and restrictions of section 28 and part of the Northwest Emmet County, Michigan, described as record and subject to the rights of the quarter of section 27 of Township 37 commencing at the Northwest corner of public and any governmental unit in North Range 4 West and containing said section 28; thence South 00°53′52″ any part thereof taken, used or deeded 97.15 acres. Subject to easements and East along said section line 907.19 feet for street, road or highway purposes. restrictions of record and subject to the

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rights of the public and any taken, used or deeded for street, road or project in the State of Utah: U.S. Route governmental unit in any part thereof highway purposes. 6, I–15 in Spanish Fork to I–70 near taken, used or deeded for street, road or Issued in Romulus, Michigan on Green River in the State of Utah. The highway purposes. September 10, 2007. project will be 127 miles long, four-lane highway (two lanes in each direction), Parcel 7 Legal Description Brad N. Davidson, Acting Manager, Detroit Airports District except for certain areas near wetlands Part of the Southwest quarter of the Office, FAA, Great Lakes Region. where a passing-lane configuration Southwest quarter of section 21 of [FR Doc. 07–4650 Filed 9–19–07; 8:45 am] would be implemented to minimize or Township 37 North Range 4 West, avoid wetland impacts. The actions by BILLING CODE 4910–13–M McKinley Township, Emmet County, the Federal agencies, and the laws Michigan, described as commencing at under which such actions were taken, the Southwest corner of said section 21; DEPARTMENT OF TRANSPORTATION are described in the Final thence North 89°27′04″ East along said Environmental Impact Statement (FEIS) section line 1234.61 feet to the POINT [4910–RY] for the project, approved on September OF BEGINNING; thence North 44°26′16″ 22, 2005, in the FHWA Record of Federal Highway Administration West 729.13 feet; thence North Decision (ROD) issued on December 22, ° ′ ″ 36 28 48 West 978.82 feet to the South Notice of Final Federal Agency Actions 2005, and in other documents in the eighth line of said section; thence North on Proposed Highway in Utah FHWA project files. The FEIS, ROD, and 89°29′26″ East along the South eighth other project records are available by line 1199.81 feet to the West eighth line AGENCY: Federal Highway contacting the FHWA or the Utah of said section; thence South 00°06′48″ Administration (FHWA), DOT. Department of Transportation at the East along said eighth line 1317.26 feet ACTION: Notice of Limitation on Claims addresses provided above. The FHWA to the South section line of said section; for Judicial Review of Actions by FEIS and ROD can be viewed and thence South 89°27′04″ West 109.93 feet FHWA, Army Corps of Engineers downloaded from the project Web site at to the POINT OF BEGINNING. (USACE) and Other Federal Agencies. http://www.udot.utah.gov/ or viewed at Being a part of the Southwest quarter public libraries in the project area. The of section 21, Township 37 North Range SUMMARY: This notice announces actions USACE decision and permit (USACE 4 West and containing 20.94 acres. taken by the FHWA, USACE, and other Permit 200250387) are available by Subject to easements and restrictions of Federal agencies that are final within contacting U.S. Army Corp of Engineers. record and subject to the rights of the the meaning of 23 U.S.C. 139(l)(1). The This notice applies to all Federal public and any governmental unit in actions relate to a proposed highway agency decisions as of the issuance date any part thereof taken, used or deeded project, U.S. Route 6, I–15 in Spanish of this notice and all laws under which for street, road or highway purposes. Fork to I–70 near Green River in the such actions were taken, including but State of Utah. Those actions grant not limited to: Parcel 8 Legal Description licenses, permits, and approvals for the 1. General: National Environmental Part of the Southwest quarter of project. Policy Act (NEPA) [42 U.S.C. 4321– section 28 and part of the Northwest DATES: By this notice, the FHWA is 4351]; Federal-Aid Highway Act [23 quarter of section 33, Township 37 advising the public of final agency U.S.C. 109 and 23 U.S.C. 128]. North Range 4 West, McKinley actions subject to 23 U.S.C. 139(l)(1). A 2. Air: Clean Air Act [42 U.S.C. 7401– Township, Emmet County, Michigan, claim seeking judicial review of the 7671(q)]. described as commencing at the section Federal agency actions on the highway 3. Land: Section 4(f) of the corner common to sections 28, 29, 32 project will be barred unless the claim Department of Transportation Act of and 33; thence South 00°09′30″ West is filed on or before March 18, 2008. If 1966 [49 U.S.C. 303]; Landscaping and along the section line common to the Federal law that authorizes judicial Scenic Enhancement (Wildflowers) [23 sections 32 and 33 55.06 feet; thence review of a claim provides a time period U.S.C. 319]. South 89°50′30″ East 75.51 feet; thence of less than 180 days for filing such 4. Wildlife: Endangered Species Act South 53°49′19″ East 474.49 feet; thence claim, then that shorter time period still [16 U.S.C. 1531–1544 and Section South 76°52′38″ East 406.85 feet; thence applies. 1536]; Marine Mammal Protection Act South 53°04′07″ East 128.03 feet to the FOR FURTHER INFORMATION CONTACT: For [16 U.S.C. 1361]; Fish and Wildlife POINT OF BEGINNING; thence North FHWA: Mr. Edward T. Woolford, Coordination Act [16 U.S.C. 661– 02°51′25″ East 303.39 feet; thence North Environmental Program Manager, 667(d)]; Migratory Bird Treaty Act [16 46°48′37″ East 349.40 feet; thence South Federal Highway Administration, 2520 U.S.C. 703–712]. 89°51′15″ East 833.91 feet; thence South West 4700 South, Suite 9A, Salt Lake 5. Historic and Cultural Resources: 46°51′08″ East 146.63 feet; thence North City, Utah 84118, Telephone (801) 963– Section 106 of the National Historic 89°50′07″ West 901.10 feet; thence 0182. The FHWA Utah Division Office’s Preservation Act of 1966, as amended South 46°48′3.7″ West 263.25 feet; normal business hours are 7 a.m. to 4:30 [16 U.S.C. 470(f) et seq.]; Archeological thence South 03°07′41″ West 337.32 p.m. [MST]. For UDOT: Ms. Rebecka Resources Protection Act of 1977 [16 feet; thence North 53°04′06″ West Stromness, Environmental Program U.S.C. 470(aa)–470(ll)]; Archeological 124.25 feet to the POINT OF Manager, Utah Department of and Historic Preservation Act [16 U.S.C. BEGINNING. Transportation, 4501 South 2700 West, 469–469(c)]; Native American Grave Being a part of the Southwest quarter Salt Lake City, Utah 84119, Telephone Protection and Repatriation Act of section 28 and part of the Northwest (801) 965–4327. (NAGPRA) [25 U.S.C. 3001–3013]. quarter of section 33, Township 37 SUPPLEMENTARY INFORMATION: Notice is 6. Social and Economic: Civil Rights North Range 4 West and containing 3.46 hereby given that the FHWA, USACE, Act of 1964 [42 U.S.C. 2000(d)– acres. Subject to easements and and other Federal agencies have taken 2000(d)(1)]; American Indian Religious restrictions of record and subject to the final agency actions subject to 23 U.S.C. Freedom Act [42 U.S.C. 1996]; Farmland rights of the public and any 139(l)(1) by issuing licenses, permits, Protection Policy Act (FPPA) [7 U.S.C. governmental unit in any part thereof and approvals for the following highway 4201–4209].

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7. Wetlands and Water Resources: Environmental Quality; E.O. 13112 ACTION: Notice and request for Clean Water Act (Section 404, Section Invasive Species. comments; correction. 401, Section 319) [33 U.S.C. 1251– (Catalog of Federal Domestic Assistance 1377]; Land and Water Conservation Program Number 20.205, Highway Planning Correction Fund (LWCF) [16 U.S.C. 4601–4604]; and Construction. The regulations Safe Drinking Water Act (SDWA) [42 implementing Executive Order 12372 In notice document E7–17877, U.S.C. 300(f)–300(j)(6)]; Rivers and regarding intergovernmental consultation on published in the issue of Tuesday, Harbors Act of 1899 [33 U.S.C. 401– Federal programs and activities apply to this September 11, 2007, at 72 FR 51904– 406]; Wild and Scenic Rivers Act [16 program.) 51905, make the following correction: U.S.C. 1271–1287]; Emergency Authority: 23 U.S.C. 139(l)(1). On page 51905, in the fourth Wetlands Resources Act, [16 U.S.C. paragraph (titled ‘‘Current Actions:’’), in 3921, 3931]; Wetlands Mitigation [23 Issued on: September 14, 2007. U.S.C. 103(b)(6)(M) and 133(b)(11)]; Walter C. Waidelich, Jr., the third sentence, the phrase ‘‘the Flood Disaster Protection Act, 42 U.S.C. Division Administrator, Salt Lake City. tobacco manufacturer’’ should read ‘‘the brewer’’. 4001–4128. [FR Doc. E7–18545 Filed 9–19–07; 8:45 am] 8. Executive Orders: E.O. 11990 BILLING CODE 4910–RY–P Dated: September 13, 2007. Protection of Wetlands; E.O. 11988 Francis W. Foote, Floodplain Management; E.O. 12898, Federal Actions to Address Director, Regulations and Rulings Division. Environmental Justice in Minority DEPARTMENT OF THE TREASURY [FR Doc. E7–18509 Filed 9–19–07; 8:45 am] Populations and Low Income BILLING CODE 4810–31–P Alcohol and Tobacco Tax and Trade Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; Bureau E.O. 13007 Indian Sacred Sites; E.O. Correction to Proposed Information 13287 Preserve America; E.O. 13175 Collections; Comment Request Notice Consultation and Coordination with Indian Tribal Governments; E.O. 11514 AGENCY: Alcohol and Tobacco Tax and Protection and Enhancement of Trade Bureau (TTB), Treasury.

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Part II

Environmental Protection Agency 40 CFR Part 63 Revision of Source Category Lists for Standards Under Sections 112(c) and 112(k) of the Clean Air Act; and National Emission Standards for Hazardous Air Pollutants for Area Sources: Electric Arc Furnace Steelmaking Facilities; Proposed Rule

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ENVIRONMENTAL PROTECTION • E-mail: [email protected]. the body of your comment and with any AGENCY • Fax: (202) 566–9744. disk or CD–ROM you submit. If EPA • Mail: National Emission Standards cannot read your comment due to 40 CFR Part 63 for Hazardous Air Pollutants for Area technical difficulties and cannot contact Sources: Electric Arc Furnace [EPA–HQ–OAR–2004–0083; FRL–8470–2] you for clarification, EPA may not be Steelmaking Facilities Docket, able to consider your comment. RIN 2060–AM71 Environmental Protection Agency, Air Electronic files should avoid the use of and Radiation Docket and Information special characters, any form of Revision of Source Category Lists for Center, Mailcode: 2822T, 1200 Standards Under Sections 112(c) and encryption, and be free of any defects or Pennsylvania Ave., NW., Washington, viruses. 112(k) of the Clean Air Act; and DC 20460. Please include a total of two National Emission Standards for copies. In addition, please mail a copy Docket: All documents in the docket Hazardous Air Pollutants for Area of your comments on the information are listed in the http:// Sources: Electric Arc Furnace collection provisions to the Office of www.regulations.gov index. Although Steelmaking Facilities Information and Regulatory Affairs, listed in the index, some information is not publicly available, e.g., CBI or other AGENCY: Environmental Protection Office of Management and Budget information whose disclosure is Agency (EPA). (OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC 20503. restricted by statute. Certain other ACTION: Proposed rule; notice of • material, such as copyrighted material, revisions to source category lists. Hand Delivery: EPA Docket Center, Public Reading Room, EPA West, Room will be publicly available only in hard SUMMARY: EPA is adding electric arc 3334, 1301 Constitution Ave., NW., copy form. Publicly available docket furnace steelmaking facilities to the list Washington, DC 20460. Such deliveries materials are available either of source categories subject to regulation are only accepted during the Docket’s electronically in http:// under Clean Air Act (CAA) section normal hours of operation, and special www.regulations.gov or in hard copy at 112(c)(6) and revising the area source arrangements should be made for the National Emission Standards for category list for the Integrated Urban Air deliveries of boxed information. Hazardous Air Pollutants for Area Toxics Strategy. At the same time, EPA Instructions: Direct your comments to Sources: Electric Arc Furnace is proposing national emission Docket ID No. EPA–HQ–OAR–2004– Steelmaking Facilities Docket at the standards for electric arc furnace 0083. EPA’s policy is that all comments EPA Docket and Information Center in steelmaking facilities that are area received will be included in the public the EPA Headquarters Library, EPA sources of hazardous air pollutants docket without change and may be West, Room 3334, 1301 Constitution (HAP). The proposed standards made available online at http:// Ave., NW., Washington, DC. The Public establish requirements for the control of www.regulations.gov including any Reading Room is open from 8:30 a.m. to mercury emissions that are based on the personal information provided, unless 4:30 p.m., Monday through Friday, maximum achievable control the comment includes information excluding legal holidays. The telephone technology (MACT) and requirements claimed to be confidential business number for the Public Reading Room is for the control of other hazardous air information (CBI) or other information (202) 566–1744, and the telephone pollutants that are based on generally whose disclosure is restricted by statute. number for the Air Docket is (202) 566– available control technology or Do not submit information that you 1742. management practices. consider to be CBI or otherwise FOR FURTHER INFORMATION CONTACT: Mr. DATES: Comments must be received on protected through http:// or before October 22, 2007, unless a www.regulations.gov or e-mail. The Phil Mulrine, Sector Policies and public hearing is requested by October http://www.regulations.gov Web site is Program Division, Office of Air Quality 1, 2007. If a hearing is requested on the an ‘‘anonymous access’’ system, which Planning and Standards (D243–02), proposed rule, written comments must means EPA will not know your identity Environmental Protection Agency, be received by November 5, 2007. Under or contact information unless you Research Triangle Park, North Carolina the Paperwork Reduction Act, provide it in the body of your comment. 27711, telephone number (919) 541– comments on the information collection If you send an e-mail comment directly 5289; fax number (919) 541–3207, e- provisions must be received by OMB on to EPA without going through http:// mail address: [email protected]. or before October 22, 2007. www.regulations.gov, your e-mail SUPPLEMENTARY INFORMATION: ADDRESSES: Submit your comments, address will be automatically captured identified by Docket ID No. EPA–HQ– and included as part of the comment I. General Information OAR–2004–0083, by one of the that is placed in the public docket and A. Does this action apply to me? following methods: made available on the Internet. If you • http://www.regulations.gov: Follow submit an electronic comment, EPA The regulated category and entities the on-line instructions for submitting recommends that you include your affected by this proposed action comments. name and other contact information in include:

1 Examples of regulated Category NAICS code entities

Industry ...... 331111 Steel mills with electric arc furnace steelmaking facilities. 1 North American Industry Classification System.

This table is not intended to be affected by this action. To determine examine the applicability criteria in 40 exhaustive, but rather provides a guide whether your facility would be CFR 63.10680 of subpart YYYYY for readers regarding entities likely to be regulated by this action, you should (National Emission Standards for

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Hazardous Air Pollutants for Area Center Auditorium, Research Triangle areas, and these HAP are referred to as Sources: Electric Arc Furnace Park, NC, or an alternate site nearby. the ‘‘Urban HAP.’’ See 64 FR 38715, July Steelmaking Facilities). If you have any 19, 1999. Section 112(c)(3) requires EPA E. How is this document organized? questions regarding the applicability of to list sufficient categories or this action to a particular entity, consult The information in this preamble is subcategories of area sources to ensure either the air permit authority for the organized as follows: that area sources representing 90 entity or your EPA regional I. General Information percent of the emissions of the 30 Urban representative as listed in 40 CFR 63.13 A. Does this action apply to me? HAP are subject to regulation. EPA of subpart A (General Provisions). B. What should I consider as I prepare my listed the source categories that account comments to EPA? for 90 percent of the Urban HAP B. What should I consider as I prepare C. Where can I get a copy of this emissions in the Integrated Urban Air my comments for EPA? document? Toxics Strategy.2 Sierra Club sued EPA, D. When would a public hearing occur? Do not submit information containing alleging a failure to complete standards CBI to EPA through http:// E. How is this document organized? II. Background Information for the area source categories listed www.regulations.gov or e-mail. Send or A. What is the statutory authority for the pursuant to CAA sections 112(c)(3) and deliver information identified as CBI proposed NESHAP? (k)(3)(B) within the time frame specified only to the following address: Roberto B. What criteria did EPA use in developing by the statute. See Sierra Club v. Morales, OAQPS Document Control this proposed NESHAP? Johnston, No. 01–1537, (D.D.C.). On Officer (C404–02), Office of Air Quality III. Addition and Revision to Source Category March 31, 2006, the court issued an Planning and Standards, Environmental Lists order requiring EPA to promulgate Protection Agency, Research Triangle IV. Proposed NESHAP for EAF Steelmaking standards under CAA section 112(d) for Park, North Carolina 27711, Attention Facilities A. What area source category is affected by those area source categories listed Docket ID EPA–HQ–OAR–2004–0083. the proposed NESHAP? pursuant to CAA section 112(c)(3). Clearly mark the part or all of the B. What are the production processes and We added electric arc furnace (EAF) information that you claim to be CBI. emissions sources? steelmaking facilities to the Integrated For CBI information in a disk or CD– C. Summary of the Proposed Requirements Urban Air Toxics Strategy Area Source ROM that you mail to EPA, mark the D. What is our rationale for the proposed Category List on June 26, 2002 (67 FR outside of the disk or CD–ROM as CBI MACT and GACT standards? 43112). The inclusion of this source and then identify electronically within V. Impacts of the Proposed Standards category on the section 112(c)(3) area the disk or CD–ROM the specific VI. Statutory and Executive Order Reviews source category list is based on 1990 information that is claimed as CBI. In A. Executive Order 12866: Regulatory Planning and Review emissions data, as EPA used 1990 as the addition to one complete version of the B. Paperwork Reduction Act baseline year for that listing. This source comment that includes information C. Regulatory Flexibility Act category was listed as contributing a claimed as CBI, a copy of the comment D. Unfunded Mandates Reform Act percentage of the total area source that does not contain the information E. Executive Order 13132: Federalism emissions for the following ‘‘Urban claimed as CBI must be submitted for F. Executive Order 13175: Consultation HAP’’: arsenic, cadmium, chromium, inclusion in the public docket. and Coordination With Indian Tribal lead, manganese, mercury, nickel, and Information so marked will not be Governments trichloroethylene. We subsequently disclosed except in accordance with G. Executive Order 13045: Protection of Children From Environmental Health discovered that the 1990 emissions data procedures set forth in 40 CFR part 2. and Safety Risks for trichloroethylene was for a few C. Where can I get a copy of this H. Executive Order 13211: Actions That specialty EAF facilities that used document? Significantly Affect Energy Supply, trichloroethylene in vapor degreasing. Distribution, or Use These emission units at both major and In addition to being available in the I. National Technology Transfer area sources are already subject to docket, an electronic copy of this notice Advancement Act standards for halogenated solvent and proposed action will also be J. Executive Order 12898: Federal Actions cleaning under 40 CFR part 63, subpart To Address Environmental Justice in available on the Worldwide Web T. Consequently, we are not proposing (WWW) through the Technology Minority Populations and Low-Income Populations any additional standards for Transfer Network (TTN). Following trichloroethylene from EAF steelmaking signature, a copy of this proposed action II. Background Information facilities. will be posted on the TTN’s policy and A. What is the statutory authority for the Section 112(c)(6) requires EPA to list, guidance page for newly proposed or proposed NESHAP? and subject to standards pursuant to promulgated rules at the following section 112(d)(2) or (d)(4), categories of address: http://www.epa.gov/ttn/oarpg/. Section 112(k)(3)(B) of the CAA sources accounting for not less than 90 The TTN provides information and requires EPA to identify at least 30 percent of emissions of each of seven technology exchange in various areas of hazardous air pollutants (HAP), which, specific HAP: alkylated lead air pollution control. as the result of emissions of area compounds, polycyclic organic matter, sources,1 pose the greatest threat to D. When would a public hearing occur? hexachlorobenzene, mercury, public health in urban areas. Consistent polychlorinated biphenyls, 2,3,7,9- If anyone contacts EPA requesting to with this provision, in 1999, in the tetrachlorodibenzofurans, and 2,3,7,8- speak at a public hearing concerning the Integrated Urban Air Toxics Strategy, tetrachloridibenzo-p-dioxin. Congress proposed rule by October 1, 2007, we EPA identified the 30 HAP that pose the targeted these HAP for regulation will hold a public hearing on October 5, greatest potential health threat in urban because of their persistence and 2007. If you are interested in attending tendency to bioaccumulate in the 1 the public hearing, contact Ms. Pamela An area source is a stationary source of environment. These HAP are also Garrett at (919) 541–7966 to verify that hazardous air pollutant (HAP) emissions that is not a major source. A major source is a stationary a hearing will be held. If a public source that emits or has the potential to emit 10 2 Since its publication in the Integrated Urban Air hearing is held, it will be held at 10 a.m. tons per year (tpy) or more of any HAP or 25 tpy Toxics Strategy in 1999, EPA has revised the area at the EPA’s Environmental Research or more of any combination of HAP. source category list several times.

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associated with adverse health effects pollutants.’’ The alternative is to base eliminating emissions of, such such as nervous system damage and standards on performance of MACT pollutants through process changes, reproductive effects. We published an under section 112(d)(2) and (3) as substitutions of materials, or other initial list of source categories under described below. Additional modifications; (2) enclosing systems or CAA section 112(c)(6) on April 10, 1998 information on the definition of processes to eliminate emissions; (3) (63 FR 17838). As discussed below in ‘‘generally available control technology collecting, capturing, or treating such section III of this preamble, we are or management practices’’ is found in pollutants when released from a adding EAF steelmaking facilities that the Senate report on the 1990 process, stack, storage or fugitive are area sources to this list of source amendments to the CAA (S. Rep. No. emission point; (4) design, equipment, categories under CAA section 112(c)(6) 101–228, 101st Cong. 1st sess. 171–172). work practices, or operational standards solely on the basis of mercury That report states that GACT is to as provided in section 112(h) of the emissions. encompass: CAA; or (5) a combination of the above.3 During the development of these * * * methods, practices and techniques The MACT floor is the minimum proposed emissions standards, we which are commercially available and control level allowed for NESHAP and discovered two EAF facilities that are appropriate for application by the sources in is defined under CAA section 112(d)(3). co-located at integrated iron and steel the category considering economic impacts For new sources, MACT standards plants that are major sources, of which and the technical capabilities of the firms to cannot be less stringent than the we were previously not aware. We plan operate and maintain the emissions control emission control achieved in practice by to list EAF steelmaking facilities as systems. the best-controlled similar source, as major sources under CAA section 112(c) Consistent with this legislative history, determined by the Administrator. The and to develop national emission we can and do consider costs and MACT standards for existing sources standards for hazardous air pollutants economic impacts in determining can be less stringent than standards for (NESHAP) for them based on the GACT. new sources, but they cannot be less performance of maximum achievable As provided in CAA section 112(d)(5), stringent than the average emission control technology (MACT). However, EPA is electing to propose standards limitation achieved by the best these two major sources are not needed under CAA section 112(c)(3) based on performing 12 percent of existing to fulfill the CAA section 112(c)(6) GACT for EAF steelmaking facilities sources in the category or subcategory requirement to develop standards for that are area sources. As stated further (for which the Administrator has sources accounting for not less than 90 below (see section IV.D.3 of this emission information) or the best percent of the emissions of mercury so preamble), we do not believe that a performing 5 sources for categories or we are not pursuing such action in this choice to base standards for these area subcategories with fewer than 30 rulemaking given the severe time sources on GACT, rather than MACT, sources. constraints to which this rulemaking is requires justification. However, should Although emission standards are subject. justification be required, we are often structured in terms of numerical proposing standards based on GACT B. What criteria did EPA use in emissions limits, alternative approaches rather than on MACT because these developing this proposed NESHAP? are sometimes necessary and are facilities are already well controlled for authorized pursuant to CAA section We are proposing standards for the metal HAP these sources emit, and 112(d)(2). For example, in some cases, mercury in response to a court-ordered a regulation based on GACT will physically measuring emissions from a deadline that requires promulgation of appropriately allow us to consider the source may be not practicable due to standards for listed CAA section costs and economic impacts of more technological and economic limitations. 112(c)(6) source categories by December stringent regulations. See the discussion Sections 112(d)(2)(D) and 112(h) of the 15, 2007 (Sierra Club v. Johnson, no. of particulate matter (PM) controls in CAA authorize EPA to promulgate a 01–1537, D.D.C). The proposed section IV.D.4 of this preamble. We design, equipment, work practice, or standards for mercury emissions from believe the consideration of costs and operational standard, or combination all EAF steelmaking facilities that are economic impacts is especially thereof, consistent with the provisions area sources of HAP are consistent with important for EAF area sources because, of CAA sections 112(d) or (f), in those CAA section 112(c)(6). given their current well-controlled cases where it is not feasible to The court order in Sierra Club v. levels, a MACT floor determination prescribe or enforce an emission Johnson also requires EPA to issue could result in only marginal reductions standard. Under CAA section 112(h)(2), standards for 10 source categories that in HAP emissions at very high costs for the phrase ‘‘not feasible to prescribe or EPA listed pursuant to CAA section modest incremental improvement in enforce an emission standard’’ includes 112(c)(3) and (k)(3)(B) by December 15, control. The consideration of cost is situations in which the EPA determines 2007. In response to this requirement, especially important for the small that the HAP emissions cannot be we are proposing standards based on businesses that operate small specialty emitted through a conveyance designed generally available control technology and stainless steel EAF facilities. and constructed to emit or capture the We are proposing standards pursuant (GACT) for the control of the Urban emissions or the application of to CAA section 112(d)(2) for mercury HAP arsenic, cadmium, chromium, measurement methodology to a emissions from all EAF steelmaking lead, manganese, and nickel from area particular class of sources is not facilities that are area sources of HAP. source electric arc furnace steelmaking practicable due to technological and Standards established under CAA facilities. The bases for these standards economic limitations. are described below. section 112(d)(2) must reflect We are proposing an emissions Under CAA section 112(d)(5), we may performance of MACT. The MACT- standard for mercury pursuant to CAA elect to promulgate standards or based regulation can be based on the section 112(d)(2)(A) that is based on requirements for area sources ‘‘which emissions reductions achievable pollution prevention measures which provide for the use of generally through application of measures, available control technologies or processes, methods, systems, or 3 Section 112(d)(4) (not relevant here) allows management practices by such sources techniques including, but not limited to: alternative risk-based standards for HAP which are to reduce emissions of hazardous air (1) Reducing the volume of, or threshold pollutants.

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‘‘reduce the volume of, or eliminate from these sources. We note first that We also examined the possibility of emissions of, such pollutants through mercury CEMS are not demonstrated for setting a direct limit on the amount of process changes, substitution of EAF, raising a threshold question of mercury entering the EAF and thus materials, or other modifications.’’ We their technical feasibility for all EAF. limiting emissions.9 However, the scrap describe below why this standard Furthermore, most EAF discharge charged to EAF includes many shapes establishes the MACT floor for mercury emissions from positive pressure and sizes, bundles, discrete pieces, and under section 112(d)(3), and further baghouses without stacks. Continuous various sizes of shredded metal. why we are not proposing beyond-the- mercury monitoring would not be Accordingly, there is no way to obtain floor standards for mercury. We note technically feasible for these EAF (i.e., representative samples for analysis of first, however, that we do not view stackless EAF), even assuming that mercury content to develop or enforce a standards requiring (or directly based mercury CEMS were otherwise mercury limit for the scrap. The number upon) pollution prevention to be work demonstrated for EAF. This is because of mercury switches in the scrap (the practices under section 112(h). This is volumetric flow rate and concentration predominant source of mercury in the because the statute specifically would need to be determined by CEMS scrap, and hence to an EAF) also cannot differentiates between emission to measure the mass emission rate of be determined for the same reasons. In standards requiring pollution mercury, and without a stack, it is addition, the switches would not be prevention measures (‘‘measures which nearly impossible to obtain an accurate recognizable after scrap dealers have reduce the volume of, or eliminate measurement of volumetric flow rate or crushed and shredded incoming scrap. emissions of, such [HAP] through * * * to obtain representative measurements Consequently, we propose that it is not substitution of materials’’) and those of mercury concentration in the feasible or practicable to establish a requiring work practices, with only the discharged emissions. Indeed, EPA has limit for mercury in the scrap. latter requiring separate justification previously determined that the use of The pollution prevention approach under section 112(h). Compare section continuous opacity monitoring systems which is the basis for the proposed 112(d)(2)(A) and (D).4 This is a (COMS) was not feasible for positive MACT standard for mercury is reasonable construction, since there is pressure baghouses without stacks for discussed below in section IV.D.1 of this reason to favor standards requiring use this reason.6, 7 preamble. of pollution prevention measures, Some EAF do have stacks, and the III. Addition and Revision to Source which eliminate HAP emissions limited amount of mercury emissions Category Lists altogether, over standards reflecting data from EAF which EPA has comes Section 112(c)(6) of the CAA requires merely the capture of some portion of an from such sources. These limited test us to list categories and subcategories of emitted HAP. There is thus no reason to data were collected using manual test disfavor pollution prevention-based sources accounting for not less than 90 methods and are therefore not reliable percent of the aggregate emissions of standards by allowing their use only if for determining an EAF’s actual the section 112(h) criteria are also each of seven specific HAP. Since the performance because these short-term publication of the original 1998 CAA satisfied. test results are not representative of the However, even assuming, for the sake section 112(c)(6) source category list, we long-term operation of a cyclic batch have collected additional data on of argument, that the proposed pollution process. The results of the different prevention standards for mercury are mercury emissions in 1990 and manual tests (typically 1-hour runs) performed another review of considered to be work practices, it is not show a variability of over two orders of feasible to prescribe or enforce an information on the 1990 baseline magnitude within a single source (as emissions limit for mercury, within the emissions inventory that served as the well as across sources) and reinforce the meaning of section 112(h). We believe basis for the listing. In re-evaluating the conclusion that continuous monitoring that continuous emission monitoring baseline inventory, we have determined would be needed to prescribe and systems (CEMS) for mercury that EAF steelmaking facilities emit enforce a numerical emissions limit for concentration and volumetric flow rate mercury and contributed to the 90 mercury.8 As noted, CEMS are not would be needed for EAF, because EAF percent of the aggregate emissions of demonstrated for these sources. For steelmaking is a batch process, and mercury in 1990, and we have updated these reasons, we do not believe it mercury emissions vary enormously our estimates of the 1990 baseline year technologically practicable to apply from batch to batch as different scrap to reflect this contribution of mercury sources are processed. Indeed, continuous measurement methodology from EAF.10 Consequently, we are emissions have been shown to vary by to even EAFs with stacks. adding EAF steelmaking facilities to the two orders of magnitude at a single list of source categories under CAA 6 5 For example, EPA estimated that 70 of 130 plant. Cf. Mossville Environmental electric arc furnaces (EAF) subject to the new section 112(c)(6) on the basis of mercury Action Now v. EPA, 370 F. 3d 1232, source performance standard (NSPS) were not emissions. 1240 (D.C. Cir. 2004) (noting that EPA required to install continuous opacity monitors This notice also announces a revision reasonably declined to establish MACT because of the configuration of their baghouse. (See to the area source category list floor levels based on single emission the EPA fact sheet for the NSPS amendments developed under our Integrated Urban available at http://www.epa.gov/ttn/oarpg/t1/ level measurements from batch process fact_sheets/eaf_npsfs.pdf). Air Toxics Strategy pursuant to CAA operations because of constant change 7 Retrofitting such sources with stacks would be section 112(c)(3). The revision changes in those levels). extremely costly for most electric arc furnaces the name of the listed area source We therefore examined the (EAFs) to the point that it would not be category, ‘‘Stainless and Nonstainless technological and economic feasibility economically practicable to do so. See ‘‘Estimated Impacts of Proposed Area Source Standard for Steel Manufacturing Electric Arc of continuous monitoring for mercury EAF’’ in EPA Docket ID No. EPA–HQ–OAR–2004– 0083. EPA believes that one takes a source as one 9 However, as explained in section IV.D.1 of this 4 Such a standard is an ‘‘emission standard’’ since finds it for purposes of applying section 112(h), and preamble, the standard we are proposing effectively it ‘‘limits the quantity * * * of emissions of air therefore that it is simply not technologically establishes such a limit. pollutants on a continuous basis’’. See section practicable to apply continuous mercury 10 Additional information on the ‘‘1990 Emissions 302(k)(definition of ‘‘emission standard’’). monitoring technology to a stackless EAF. Inventory of Section 112(c)(6) Pollutants’’ is 5 See ‘‘Analysis of Mercury Emissions Test Data’’ 8 See ‘‘Analysis of Mercury Emissions Test Data’’ available at http://www.epa.gov/ttn/atw/112c6/ in Docket ID No. EPA–HQ–OAR–2004–0083. in EPA Docket ID No. EPA–HQ–OAR–2004–0083. 112c6pg.html.

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Furnaces (EAF)’’ to ‘‘Electric Arc carbon steels. Some stainless steel nickel, are introduced as alloying Furnace Steelmaking Facilities.’’ We are grades contain 12 to 28 percent elements and are necessary to produce making this revision to clarify that the chromium and 4 to 25 percent nickel. stainless and specialty steels. source category includes all types of U.S. minimills are the largest Capture systems for emissions from steel made in EAF, such as stainless recyclers of metal scrap in the world. EAF typically include direct-shell steel, carbon steel, specialty steel, and Recycled iron and steel scrap evacuation control (DEC) systems; other grades and alloys of steel. This is nationwide in 2004 included 25 percent canopy hoods, side draft hoods, and simply a change in the name of the ‘‘home scrap’’ (from current operations tapping hoods; partial or total source category and does not change the at the plant), 26 percent ‘‘prompt scrap’’ enclosures; scavenger duct systems; and universe of sources that were the basis (from plants manufacturing steel building evacuation systems. The most of the original listing notice. products), and 49 percent post- common types of capture systems for consumer scrap. The primary source of ladle metallurgy are canopy hoods, side IV. Proposed NESHAP for EAF post-consumer scrap is the automobile, draft hoods, and close fitting hoods. Steelmaking Facilities and in 2004, the steel industry recycled Nearly all plants duct process and A. What area source category is affected 14.2 million tons of iron and steel scrap fugitive emissions to a baghouse. These by the proposed NESHAP? from 14 million vehicles. capture systems and PM control devices are highly efficient for the capture and B. What are the production processes The EAF steelmaking area source control of PM and HAP metals that are and emissions sources? category consists of facilities engaged in in particulate form, including the Urban the production of steel using EAF to Most EAF are equipped with three HAP arsenic, cadmium, chromium, melt primarily ferrous scrap to produce carbon electrodes that are raised or lead, manganese, and nickel. However, molten steel. The molten steel is refined lowered through the furnace roof. When mercury emitted from the EAF is in by ladle metallurgy processing and the electrodes are retracted, the furnace vapor form and is not controlled by the subsequently cast into basic steel shapes roof can be rotated to allow the charge PM control devices. that are further processed in rolling of scrap steel by an overhead crane. A detailed survey of 27 plants showed mills. Electric current that is passed between that EAF steelmaking facilities use scrap The U.S. steel industry produced the electrodes and through the scrap specifications, scrap management plans, about 106 million tons of raw steel in generates heat to melt the scrap. The and inspections to ensure that charge 2006, and approximately 93 stages of each production cycle include materials do not adversely affect the ‘‘minimills’’ that melt ferrous scrap in charging (loading scrap and other raw quality of steel or create dangerous EAF accounted for 57 percent of the materials into the furnace), melting, operating conditions. Common total U.S. production. Critically, for removing slag (a layer of impurities that requirements include testing for purposes of the mercury standard forms on top of the molten steel), and radiation; rejecting scrap containing proposed in this rule, the EAF at tapping (pouring molten steel into a sealed containers, hazardous materials, minimills produce steel by melting ladle). Operating cycles in this batch or explosives; and prohibiting materials recycled ferrous scrap. The reason this process range from 35 to more than 200 such as lead, copper, oil, grease, is critical is that the mercury emitted by minutes; the longer cycle times are batteries, and refrigerants. Most plants EAF comes almost exclusively from generally used when producing also require some type of visual automotive scrap, and approximately 50 stainless and specialty steels. After inspection of incoming scrap. These to 80 percent of this mercury can be tapping, the steel is transferred to the scrap management procedures also eliminated from the scrap feed by ladle metallurgy facility where it serve to reduce HAP emissions by pollution prevention measures carried undergoes additional refining in a ladle preventing HAP materials and out upstream of the EAF. to produce the desired final properties. precursors from entering the EAF and The production of steel in minimills After the composition and temperature subsequently being emitted. has increased dramatically over the past are adjusted in the ladle metallurgy 30 years. Minimills accounted for 10 facility, the molten steel is transferred to C. Summary of the Proposed percent of the national steel production the continuous caster, which forms the Requirements in 1970, 30 to 40 percent in the 1980s, steel into semi-finished shapes. The This section presents a summary of 40 to 50 percent in the 1990s, and (as steel shapes are then processed in the requirements of the proposed rule. noted) 57 percent in 2006. The growth rolling mills to produce the final steel Additional details and the rationale for has been attributed in part to an product. the proposed requirements are provided expansion in the types and quality of Emissions from the EAF occur during in the following section IV.D of this steel products that minimills can charging, melting, and tapping. preamble. produce, including heavy structurals, Emissions may also occur when the rail, plate, specialty bar, hot rolled, cold molten steel is processed at the ladle 1. Applicability and Compliance Dates rolled, galvanized, and stainless flat metallurgy facility. The type and The proposed NESHAP applies to rolled products. volume of emissions of HAP metals are each new or existing EAF steelmaking Most of the steel produced in EAF is affected by the quantity and type of facility that is an area source of HAP. carbon steel used in the manufacture of HAP metals in the ferrous scrap being We are proposing that the owner or construction materials, automobiles, melted and the addition of certain alloys operator of an existing area source that appliances, and other applications. (e.g., chromium, manganese, and does not have to install or modify Approximately 4 percent (about 2 nickel). Some HAP metals, such as emissions control equipment to meet million tons) is specialty and stainless manganese, are an inherent and the opacity limit for fugitive emissions steel, which are high value steel necessary component of ferrous scrap comply with all applicable rule products. The types of steel are defined and the final steel product. Other HAP requirements no later than six months by their composition of alloying metals, such as mercury, arsenic, and after the date of publication of the final elements. Stainless and alloy steels cadmium, are undesirable elements rule in the Federal Register. We are contain less carbon and zinc and more introduced with the ferrous scrap. Other proposing that the owner or operator of chromium, manganese, and nickel than HAP metals, such as chromium and an existing area source that must install

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or modify emission control equipment responsibilities for steelmakers as switches removed from motor vehicle to meet the opacity limit for fugitive described in the Memorandum of scrap sent to the facility during the emissions may request a compliance Understanding. The NVMSRP is previous year and the basis for the date for the opacity limit that is no later described in detail in section IV.D.1 of estimate. The Administrator would be than two years after the date of this preamble. able to request documentation or publication of the final rule in the EAF facilities could also obtain scrap additional information from the owner Federal Register based on a from scrap providers participating in or operator at any time. The site-specific demonstration to the satisfaction of the other programs. To do so, the facility plan must establish a goal for the permitting authority that the additional owner or operator would have to submit removal of at least 80 percent of the time is needed. The owner or operator a request to the Administrator for mercury switches. All documented and of a new affected source would be approval to comply by purchasing scrap verifiable mercury-containing required to comply with all applicable from scrap providers that are components removed from motor rule requirements by the date of participating in another switch removal vehicle scrap would count towards the publication of the final rule in the program and demonstrate to the 80 percent goal. Federal Register (if the startup date is Administrator’s satisfaction that the An equivalent compliance option on or before promulgation) or upon program meets the following specified would be provided for EAF steelmakers startup (if the startup date is after criteria: (1) There is an outreach who do not utilize motor vehicle scrap promulgation). program that informs automobile that contains mercury. The option dismantlers of the need for removal of would require the facility to certify that 2. Proposed MACT Standards for the mercury switches and provides training the only materials they are charging Control of Mercury and guidance on switch removal, (2) the from motor vehicle scrap are materials The proposed standards for mercury program has a goal for the removal of at recovered for their specialty alloy, such are based on pollution prevention and least 80 percent of the mercury as chromium in certain exhaust systems. require an EAF owner or operator who switches, and (3) the program sponsor Such materials are known not to contain melts scrap from motor vehicles either must submit annual progress reports on mercury, and because the specialty to purchase (or otherwise obtain) the the number of switches removed and steels must meet stringent product motor vehicle scrap only from scrap the estimated number of motor vehicle quality and performance specifications, providers participating in an EPA- bodies processed (from which a automobile scrap with contaminants approved program for the removal of percentage of switches removed is easily such as mercury, lead, zinc, and copper mercury switches or to fulfill the derivable). is not accepted.12 alternative requirements described EAF facilities that purchase motor vehicle scrap from scrap providers that 3. Proposed GACT Standards for EAF below. EAF facilities participating in an and Ladle Metallurgy Operations approved program must maintain do not participate in an EPA-approved We propose that the owner or records identifying each scrap provider mercury switch removal program would operator would be required to install, and documenting the scrap provider’s have to prepare and operate pursuant to operate, and maintain capture systems participation in the EPA-approved and in conformance with a site-specific for EAF and ladle metallurgy operations mercury switch removal program. A plan for the removal of mercury that convey the collected gases and proposed compliance option is for the switches. The facility’s scrap fumes to a venturi scrubber or baghouse EAF facility to prepare and operate specifications would have to include a for the removal of PM. We are proposing pursuant to an EPA-approved site- requirement for the removal of mercury separate emissions limits for new and specific plan that includes switches, and the plan must include existing EAF steelmaking facilities that specifications to the scrap provider that provisions for obtaining assurance from scrap providers that mercury switches produce less than 150,000 tpy of mercury switches must be removed have been removed. The plan would be stainless or specialty steel, and for from motor vehicle bodies at an submitted to the Administrator for larger, non-specialty EAF steelmaking efficiency comparable to that of the approval and would demonstrate how facilities. The small facilities would be EPA-approved mercury switch removal the facility will comply with specific required to comply with a PM emissions program (see below). An equivalent requirements that include: (1) A means limit of 0.8 pounds of PM per ton (lb/ compliance option is provided for of communicating to scrap purchasers ton) of steel for each control device facilities that do not utilize motor and scrap providers the need to obtain serving an EAF or ladle metallurgy vehicle scrap that contains mercury or provide motor vehicle scrap from operation and an opacity limit of 6 switches. which mercury switches have been percent for melt shop emissions. All We expect most facilities that use removed and the need to ensure the other EAF steelmaking facilities (both motor vehicle scrap will choose to proper disposal of the mercury existing and new) would be required to comply by purchasing motor vehicle switches, (2) provisions for obtaining meet a PM limit of 0.0052 grains per dry scrap only from scrap providers who assurance from scrap providers that standard cubic foot (gr/dscf) for participate in a program for removal of motor vehicle scrap provided to the emissions from a control device for an mercury switches that has been facility meets the scrap specifications, EAF or ladle metallurgy operation. The approved by the Administrator. The (3) provisions for periodic inspection, opacity of emissions from melt shops National Vehicle Mercury Switch site visits, or other means of from these sources would be limited to 11 Recovery Program (NVMSRP) would corroboration to ensure that scrap 6 percent. be an approved program under this providers and dismantlers are Performance tests would be required proposed standard. Facilities choosing implementing appropriate steps to for each emissions source to to use the NVMSRP as a compliance minimize the presence of mercury demonstrate initial compliance with the option would have to assume all of the switches in motor vehicle scrap, (4) provisions for taking corrective actions 12 Letter from Joseph Green, Counsel to the 11 Additional details can be found at http:// Specialty Steel Industry of North America, to Steve www.epa.gov/mercury/switch.htm and in section if needed, and (5) requiring each motor Fruh, Environmental Protection Agency. IV.D.1 of this preamble. In particular, see the signed vehicle scrap provider to provide an Information Regarding Specialty Steel Industry Memorandum of Understanding. estimate of the number of mercury Segment. July 30, 2004.

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PM and opacity limits. Provisions are that minimizes the amount of specific plan would also contain procedures for included in the proposed rule for contaminants in the scrap. determining if these requirements are conducting the tests. The owner or The proposed requirements are based met (e.g., visual inspection or periodic operator of an existing EAF steelmaking on two pollution prevention approaches audits of scrap suppliers) and facility would be allowed to certify depending on the type of scrap that is procedures for taking corrective actions initial compliance with the emissions used, and a facility may have some with vendors whose shipments are not limits if a previous test was conducted scrap subject to one approach and other within specifications. during the past 5 years using the scrap subject to the other approach. One provision is for scrap that does not 5. Proposed Requirements for methods and procedures in the rule and Recordkeeping and Reporting either no process changes have been contain certain contaminants and would made since the test, or the owner or simply prohibit the processing of scrap Area sources subject to the proposed operator can demonstrate that the test containing these contaminants requirements for EAF and ladle results, with or without adjustments, (restricted scrap). Compliance would be metallurgy operations would be subject reliably demonstrate compliance despite demonstrated by a certification that the to the recordkeeping and reporting process changes. owner or operator will not process scrap requirements of the part 64 CAM rule. All EAF steelmaking facilities would with the contaminants. This scrap The general recordkeeping requirements be required to obtain a title V permit. management approach is expected to be of the part 64 rule directs the owner or The proposed rule would require each most useful to stainless and specialty operator to comply with the EAF steelmaking facility to monitor the steel producers with stringent scrap recordkeeping requirements for title V capture system, PM control device, and specifications that do not permit the use operating permits in 40 CFR 70.6(a)(3)(ii), which require records of melt shop; maintain records; and submit of motor vehicle scrap and scrap analyses, measurements, and sampling reports according to the compliance containing free organic liquids. The data. The part 64 rule also requires the assurance monitoring (CAM) other approach for scrap that may owner or operator to maintain records of requirements in 40 CFR part 64. The contain certain contaminants is more monitoring data, monitor performance existing part 64 rule requires the owner prescriptive and requires a pollution data, corrective actions taken, any or operator to establish appropriate prevention plan, scrap specifications, written quality improvement plan (QIP), ranges for selected indicators for each and procedures for determining that any activities undertaken to implement emissions unit (i.e., operating limits) these requirements are met. This a QIP, and other supporting information such that operation within the ranges pollution prevention approach was required by the part 64 rule (such as will provide a reasonable assurance of developed primarily for carbon steel producers that accept motor vehicle data used to document the adequacy of compliance with the emissions scrap and many other types of ferrous monitoring, or records of monitoring limitations or standards. scrap. maintenance or corrective actions). The CAM rule requires the owner or Under the restricted scrap provision, The general reporting requirements of operator to submit certain monitoring the plant owner or operator would agree part 64 require the owner or operator to information to the permitting authority to restrict the use of certain scrap, submit monitoring reports to the for approval. This information includes: including metallic scrap from motor permitting authority in accordance with (1) The indicators to be monitored; (2) vehicle bodies, engine blocks, oil filters, the requirements for facilities with title the ranges or designated conditions for oily turnings, machine shop borings, V operating permits. The title V such indicators, or the process by which transformers and capacitors containing reporting requirements in 40 CFR such indicator ranges or designated polychlorinated biphenyls (PCBs), lead- 70.6(c)(1) and 40 CFR 71.6(c)(1) include conditions will be established; (3) containing components, chlorinated a 6-month monitoring report, deviation performance criteria for the monitoring; plastics, or free organic liquids. The reports, and annual compliance and if applicable, (4) the indicator restriction on lead-containing certifications. The reporting ranges and performance criteria for a components would not apply to the requirements under part 64 requires that CEMS, COMS, or predictive emissions production of leaded steel (where lead the 6-month monitoring report include: monitoring system. The owner or is obviously needed for production). (1) Summary information on the operator also must submit a justification The other proposed scrap number, duration and cause (including for the proposed elements of the management provision would require unknown cause, if applicable) of monitoring control device (and process the plant owner or operator to prepare excursions or exceedances, as and capture system, if applicable) and a pollution prevention plan for metallic applicable, and the corrective actions operating parameter data obtained scrap selection and inspection to taken; (2) summary information on the during the conduct of the applicable minimize the amount of chlorinated number, duration and cause (including compliance or performance test. plastics, lead (except for the production unknown cause, if applicable) for If monitoring indicates that the unit is of leaded steel), and free organic liquids. monitor downtime incidents (other than operating outside of the acceptable This plan would be submitted to the downtime associated with zero and range established in its permit, the Administrator for approval. The owner span or other daily calibration checks, if owner or operator must return the or operator would be required to keep applicable); and (3) a description of the operation to within the established a copy of the plan onsite and train plant actions taken to implement a QIP during range consistent with 40 CFR 64.7(d). personnel with materials acquisition or the reporting period. Upon completion inspection duties in the plan’s of a QIP, the owner or operator must 4. Proposed GACT Standards for Scrap requirements. include in the next summary report Management The plan would include documentation that the implementation In addition to meeting PM and specifications for scrap materials to be of the plan has been completed and opacity limits reflecting GACT, we are depleted (to the extent practicable) of reduced the likelihood of similar levels also proposing that EAF facilities be lead-containing components (except for of excursions or exceedances occurring. required to restrict the use of certain the production of leaded steel), All EAF steelmaking facilities subject scrap or follow a pollution prevention undrained used oil filters, chlorinated to this proposed NESHAP would also be plan for scrap inspection and selection plastics, and free organic liquids. The subject to certain specified requirements

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of the NESHAP general provisions (40 D. What is our rationale for the different batches of scrap are melted. CFR part 63, subpart A). The general proposed MACT and GACT standards? The limited sampling results of input materials likewise indicate that the provisions include requirements for 1. Proposed MACT Standard for mercury content of scrap typically initial notifications; startup, shutdown, Mercury and malfunction records and reports; varies widely.14 recordkeeping; and semiannual excess Background. Mercury enters the EAF We also examined scrap emissions and monitoring system steelmaking process almost exclusively specifications that may be in use to with the ferrous scrap that is charged to performance reports. The information reduce mercury emissions. Three the furnace. A few other materials are companies reported in their survey required in these records and reports is charged to the EAF in small quantities responses that their scrap specifications similar to the information required by (e.g., coke, coal, lime); however, they prohibited mercury-containing the CAM rule (40 CFR part 64) and the contribute little mercury because they components. However, there was no operating permits rules (40 CFR parts 70 are used in very small quantities relative measure of effectiveness of the written and 71). to the scrap charge and contain virtually specification. The proposed NESHAP also includes no mercury in any case. The major Over the past few years, there has specific recordkeeping and reporting source of mercury in ferrous scrap is been an increasing awareness that a requirements for area source facilities convenience light switches in end-of- highly effective way of reducing subject to requirements for control of life vehicles that contain 0.8 grams (g) mercury releases to the environment contaminants from scrap. The area to 1.2 g of mercury per switch. These from scrap using entities like EAFs is to source facilities would be required to switches (called mercury switches or tilt remove mercury switches from end-of- keep records to demonstrate compliance switches) control lights under the hoods life vehicles prior to crushing, with the requirements for their and in the trunks of older model shredding, and melting. Numerous interested parties have been involved at pollution prevention plan for vehicles. The Ecology Center estimated the local, State, and national level in the minimizing the amount of chlorinated that the vehicles retired in 2003 contained 8.5 million switches and 9.3 development and implementation of plastics, lead, and free organic liquids switch removal programs, including charged to a furnace or for the use of tons of mercury. Pilot studies in New Jersey and Michigan reported 0.54 to 0.8 local and State environmental agencies, only restricted scrap and the site- mercury switches per vehicle processed. national and local environmental specific plan for mercury or any of the For 14 million vehicles recycled in groups, steel recyclers, steel producers, mercury compliance options. 2004, the number of switches thus automobile makers, various EPA offices, As noted above, facilities subject to would be in the range of 7.6 to 11 and others. Many successful State and the site-specific plan for mercury would million. Although mercury switches local switch removal programs are be required to keep records and submit were phased out of automobiles in 2002, already in place, and more are expected semiannual reports on the number of there is a 10 to 15 year supply of in the future. mercury switches removed by the scrap existing vehicles destined for recycling Several State programs for mercury provider or the weight of mercury that still contain the switches. There are switch removal have been implemented, and there are many different variations. recovered from those switches, an other components in automobile scrap Some programs are mandated by law, estimate of the percent of mercury which contain small amounts of mercury, such as anti-lock braking and others are voluntary. Some offer switches recovered, and certification financial incentives provided by that the recovered mercury switches sensors, security systems, and active ride control systems. However, most of different stakeholders, some specify were managed at RCRA-permitted financial incentives to be provided by facilities. In contrast, facilities the mercury is contributed by convenience light switches, which are automobile makers, and some have no participating in an EPA-approved financial incentives. Some have a strict estimated to be the source of 87 percent program for switch removal must keep accounting of switches removed and of the mercury in motor vehicle scrap by records that identify their scrap requirements for proper collection, the Ecology Center.13 providers and document that they We have very limited data on the management, and disposal of the participate in an approved switch mercury species emitted from EAFs; switches. There have been direct measurements removal program. As discussed in more however, the limited data indicate that of the mercury emission reductions that detail in section IV.D.1 of this preamble, over 99 percent of the mercury can be achieved at minimills by switch we are proposing to require more emissions are in the gaseous form, and removal programs. For example, a pilot extensive records for a site-specific plan about 93 percent of the gaseous mercury program administered by the New Jersey than for an approved program because is elemental mercury. Although Department of Environmental Protection extensive recordkeeping, reporting, and baghouses are highly efficient at measurement of success are already reported a reduction of 50 percent in removing HAP metals that are in the mercury emissions when the EAF required for approval of such a removal particulate phase, the baghouses do not melted scrap that had been processed in program, the NVMSRP being the prime control gaseous or vapor phase mercury a switch removal program.15 We also example. and thus (for practical purposes) do not identified one minimill in Minnesota All facilities subject to the control mercury emissions from EAFs. that had implemented a mercury switch requirements for the control of No EAFs use add-on controls for removal program that included removal contaminants from scrap would be gaseous mercury emissions. prior to processing in their on-site The limited test data show extreme required to submit semiannual reports shredder and a system for paying other variability (orders of magnitude) in according to the requirements in mercury emissions from plant to plant 14 See ‘‘Analysis of Mercury Emissions Test Data’’ § 63.10(e) of the general provisions. The and from the same plant over time as report would identify any deviation in Docket ID No. EPA–HQ–OAR–2004–0083. 15 ‘‘Mercury Switch Data Collection Pilot from the rule requirements and the 13 The Ecology Center report and other Project.’’ Prepared by K.L. Woodruff. New Jersey corrective action taken. information cited for mercury switches is available Department of Environmental Protection. March 24, in EPA Docket ID No. EPA–HQ–OAR–2004–0083. 2004.

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scrap suppliers to remove switches. Corporation (ELVS),18 the American time, there will be robust information This program has resulted in a Iron and Steel Institute, the Steel available as to switch removal rates and quantifiable reduction in environmental Manufacturers Association, the Institute rate of fleet retirement. releases of mercury. These two studies of Scrap Recycling Industries, the The NVMSRP was designed to confirm that a national mercury switch Automotive Recyclers Association, harmonize with existing State programs removal program for end-of-life vehicles Environmental Defense, the Ecology and to be implemented State-by-State by will reduce mercury emissions. Center (Ann Arbor), and representatives the participants, in consultation with Switch removal programs reduce of the Environmental Council of the appropriate State agencies, in the mercury releases to all media. Switch States. The goal of the NVMSRP is to remaining States to form a coordinated removal reduces mercury releases to air, significantly reduce air emissions of national program. The NVMSRP has water, and land when automobiles are mercury from steelmaking facilities that shown success in just a few months crushed and shredded prior to delivery utilize auto shred by substantially following the MOU. As of July 9, 2007, to the minimills. Mercury reducing the number of mercury- programs were operational in 45 States, contamination of auto shred residue containing switches in scrap and 5,633 participants have collected (plastics, fabrics, and other unwanted automobiles before they are crushed and more than 575,841 mercury switches materials in the automobile) is reduced shredded for recycling. This is being with 1,267 pounds of mercury. making safer the further management of accomplished through education and Programs are expected to be the material. The switches themselves outreach for those removing switches; implemented in all of the remaining are isolated and managed in RCRA removal, collection and management of States in 2007. subtitle C hazardous waste management switches; transport of the switches to a Proposed MACT floor determination. facilities where they are subject to qualified retorter that has the permits More than 12 percent of the EAF stringent regulatory control. As a result that allow for managing the switches steelmaking facilities are participants in of the mercury switch removal under RCRA subtitle C; recordkeeping this national program and have been programs, mercury emissions are and accountability of mercury recovery; participants in previous State and local reduced at all facilities which use the scrap selection and corroboration; and programs. We believe that these scrap as raw material, including not review and improvement of the operations pursuant to the national only EAFs but integrated iron and steel NVMSRP. The vehicle manufacturers program represent the best performers plants and iron and steel foundries. and steelmakers have created a three- and best performance for mercury—the Finally, mercury emissions are reduced year, $4 million dollar implementation chief source of mercury in emissions is from scrap that is exported and melted fund in support of the program. The being removed from feedstock—so that in furnaces in other countries. fund will support the implementation of the MACT floor for new and existing The National Vehicle Mercury Switch the NMSRP through incentive payments EAF steelmaking facilities is for the owner or operator to operate pursuant to Recovery Program (NVMSRP).16 A to those entities recovering (i.e. pulling) such a program; i.e., to obtain scrap only significant step forward in reducing the switches. Performance will be from scrap providers that are first mercury emissions was made on August assessed on a regular basis by all of the removing mercury switches pursuant to 11, 2006 when a Memorandum of participating parties. the national program or an equivalent Understanding (MOU) was signed by Finally, the MOU contains a provision program of demonstrably equal representatives of the steel industry, providing that the agreement may effectiveness.20 We are also proposing automobile makers, scrap recyclers, terminate with the consent of the parties based on the phase out of automobiles that a switch removal program is the environmental groups, State and local containing mercury switches. A MACT floor for new sources because the agencies, and EPA.17 The MOU potential termination date mentioned in best-controlled similar source is among established the NVMSRP, and this the MOU is December 31, 2017, a date those that prevent mercury switches program has been implemented and is when it is projected that 90 percent of from entering with the scrap. already removing and recovering vehicles containing mercury switches We examined the features of the mercury switches from end-of-life will be retired.19 EPA believes that any NVMSRP and other switch removal vehicles before the metallic scrap is issues raised by this potential ‘‘sunset’’ programs to identify those features that recycled at EAFs (and other steel- provision are best addressed when EPA would be the necessary components of producing entities). reexamines the MACT standard a national emission standard to ensure The NVMSRP is the result of a two- pursuant to section 112(d)(6) (which that the program would be effective at year collaborative effort involving EPA, must occur no later than 2015). At that reducing mercury emissions. These the End of Life Vehicle Solutions features include assurance that each 18 ELVS is a non-profit corporation established by 16 This section describes the national switch several motor vehicle manufacturers who are listed 20 We estimate that the mercury switch removal recovery program in detail. As discussed in the at http://www.elvsolutions.org/about.htm. program will reduce mercury emissions to below 90 following sections of this preamble, the proposed 19 The MOU states ‘‘The NVMSRP will be mg Hg/ton of steel produced (based on two State rule does not codify these details as part of the implemented until December 31, 2017 based on pilot program studies showing approximately 50 proposed standard for mercury emissions. The estimates that 90% of the vehicles containing percent reduction from switch removal and average proposed rule requires the owner or operator to: (1) mercury switches would be retired by that time. If, baseline mercury emissions of 180 mg Hg/ton), Certify they are participants in the national program before that date, based on Program data and other which results in an estimated reduction of 5 tpy of and that scrap is purchased only from scrap information, the Parties or their designees mercury. For perspective, 90 mg/ton of steel providers participating in such a national program, determine that the number of remaining Mercury corresponds to a trace mercury level of 0.1 ppm in (2) maintain records documenting such Switches no longer constitutes a significant source the steel scrap or the equivalent of about one participation, and (3) submit semiannual reports if of mercury, they may determine that the program mercury switch (one gram or 1,000 mg of mercury) there are any deviations from the requirements. should end. In such a case, the Parties may per 10 tons of steel scrap (about one switch per ten However, the proposed rule also allows an owner terminate this MOU through written notice to all end-of-life vehicles at one ton of steel per vehicle). or operator to comply with the proposed rule if they signatories and Participants. If the Parties or their In contrast, we estimate that the MACT floor based can demonstrate that they are participating in a designees determine that the number of mercury on our limited mercury emissions test data, which program that is equivalent to the national program switches is still significant after that date, they may comes from a time when switch removal and is of demonstrably equal effectiveness. extend the Program. If the Program is extended, the agreements were not in place, would be 650 mg Hg/ 17 Additional details and the signed Parties and U.S. EPA may continue this MOU ton of steel. Additional details are provided in Memorandum of Understanding can be found at through written mutual consent of all parties and ‘‘Analysis of Mercury Emissions Test Data’’ in http://www.epa.gov/mercury/switch.htm. U.S. EPA.’’ Docket ID No. EPA–HQ–OAR–2004–0083.

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facility is participating in a switch One year following the effective date scrap from end-of-life vehicles. removal program that has been of the MOU and each year thereafter, the Participating steelmakers were to approved by the Administrator, a parties or their designees and EPA initiate the following steps when the program goal for the percent of switches agreed to meet to review the NVMSRP went into effect: removed (80 percent), a system that effectiveness of the program at the State • Issue a statement that the accounts for the number of switches (or level based upon recovery and capture individual steel company is quantity of mercury) removed and the rates. The parties to the agreement participating in the NVMSRP. number of vehicle bodies processed, a agreed to use the results to improve the • Acting independently, develop a mechanism to ensure the switches are performance of the program and to plan demonstrating the manner through properly disposed of or recycled, and an explore implementation of a range of which it is participating in the outreach program that informs options in that effort. Two and one-half NVMSRP. The plan should include dismantlers of the need for removal of years from the inception of the program, facility-specific implementation mercury switches and provides training the parties agreed to meet and review elements, corporate-wide policies, and/ and guidance for removal. The national overall program effectiveness and or efforts coordinated by a trade program has these features, and we are performance. This review will include association as appropriate for each proposing that these features represent discussion of the number of switches facility. the MACT floor for mercury for new and that have been collected and what • Provide in the plan documentation existing sources because this is the factors have contributed to program of direction to appropriate staff to mercury control approach that is being effectiveness. communicate to suppliers the need to used by the best-performing sources. A key element of measuring the promote the NVMSRP with suppliers The national program also has a success of the program is maintaining a throughout the scrap supply chain. The mechanism to measure performance database of participants that has steel mill should be able to provide because the number of switches and detailed contact information, examples of materials that it uses for amount of mercury recovered is documentation showing when the outreach to suppliers, such as letters, reported by State, and from an estimate participant joined the program (or contract language, policies for of the number of vehicles processed, the started submitting mercury switches), purchasing agents, and scrap inspection progress toward the goal of 80 percent records of all submissions by the protocols. participant including date, number of removal can be determined. The MOU • Strongly encourage their suppliers mercury switches, and confirmation that also includes ongoing measures to track and others in the scrap supply chain to the participant has submitted mercury and measure progress. For example, the support and participate in the NVMSRP. switches as expected. Another parties will assess development and • Take steps to minimize the important element is aggregated implementation of State plans and presence of mercury in scrap, which information to be updated on a quarterly identification and participation of includes notifying suppliers that the basis, including progress reports, program participants at three-month steelmaker, acting independently summaries of the number of program intervals for the first year following the participants by State, individual pursuant to the NVMSRP, intends to use effective date of the MOU. At six-month program participants, and State and in their operations, to the maximum intervals thereafter, the parties will national recovery totals. The program is extent possible, scrap from vehicles collectively review by State the status of also estimating the number of motor which do not contain mercury switches implementation and participation in the vehicles recycled. The NVMSRP will or from which mercury switches have program and make adjustments as issue reports quarterly during the first been removed and to adapt their necessary. The indicators to be reviewed year of the program, every six months in respective purchasing practices to that will include the status of plans for 50- end. the second and third year of the • State implementation, number of States program, and annually thereafter. The Use the ELVS database or other where the program has been initiated, reports prepared by ELVS will include appropriate means to demonstrate that the status of Web-based information on the total number of dismantlers or other suppliers (spot suppliers and those the NVMSRP, the status of identification potential participants identified; the under continuous contracts) are of dismantlers and dismantler total number of dismantlers or others participating as anticipated in the participation in all States (starting with contacted; and the total number of NVMSRP and periodically re-affirm those States targeted for initial dismantlers or others participating. The their commitment to provide only implementation), and the status of the annual report will include the total reduced-mercury automobile scrap. mercury recovery database and rate of mercury (in pounds) and number of Steelmakers will conduct occasional information collection. mercury switches recovered nationwide; spot checks, site visits or other means of The parties to the MOU expect that in the total pounds of mercury, number of corroboration to ensure that suppliers the first three years of the program, mercury switches, and an estimated are aware of the need and are capture rates will be ramping up due to national capture rate, with information implementing appropriate steps to the realities of program implementation organized by State, compared with the minimize the presence of mercury in and will not fully achieve the 80 to 90 expected range of mercury switch automobile scrap. percent switch recovery rate goal. It is retirement rates for each State; and the • Cooperate with ELVS in the expected that a minimum of four total number and identity of dismantlers development of education, training million mercury switches will be or others dropped due to inactivity or materials, and outreach where recovered during the first three years of withdrawal from the program. appropriate. the program in addition to the mercury Facilities choosing to use the • Work with the Institute of Scrap being recovered by existing State NVMSRP to comply with this proposed Recycling Industries to assure that any programs. The parties agreed to make standard would have to assume all of scrap work practice standards or other every effort to exceed this amount the responsibilities for steelmakers as programs that may be implemented in through aggressive implementation of described in the MOU and take steps accordance with the NVMSRP take into the responsibilities detailed in this consistent with the NVMSRP to account market and technological agreement. minimize the presence of mercury in factors and do not create unreasonable

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or unworkable certification implementing appropriate steps to locate and remove the ABS switch. In requirements for scrap processors. minimize the presence of mercury other cases, the ABS mercury bullet We propose that the Administrator switches in motor vehicle scrap, (4) a could not be removed separately can evaluate the success of the program goal for the removal of at least 80 because it was encased in a plastic resin at any time, identify States where percent of the mercury switches, (5) material. Since the removal of these improvements might be needed, provisions for taking corrective actions other mercury-containing components is recommend options for improving the if needed, and (6) requiring each motor costly and not practical in many cases, program in a particular State, and if vehicle scrap provider to provide an we have initially determined that the necessary, disapprove the program as estimate of the number of mercury removal of these other mercury- implemented in a State from being used switches removed from motor vehicle containing components is not justified to demonstrate compliance with this scrap sent to the facility during the as a beyond-the-floor standard. proposed rule based on an assessment of previous year and the basis for the However, we propose to encourage their this performance. The evaluation would estimate. The Administrator would be removal by crediting all documented be based on progress reports submitted able to request documentation or and verifiable mercury-containing to the Administrator that provide the additional information and change the components removed from motor number of mercury switches removed, approval status of the plan at any time vehicle scrap (such as sensors in ABS the estimated number of vehicles based on a review of progress toward systems, security systems, active ride processed, and percent of mercury meeting the switch removal goal and control, and other applications) when switches recovered. The Administrator other factors. evaluating progress towards the 80 will assess the information with respect We developed an equivalent percent goal. to the program’s goal for percent switch compliance option (also based on We also examined the feasibility and recovery and trends in recovery rates. pollution prevention) for steelmakers cost of an add-on control device for Although the national program would who do not purchase motor vehicle mercury and continuous emissions be an EPA-approved program for the scrap that contains mercury switches. monitoring as a beyond-the-floor option purpose of complying with the The compliance option would require for mercury for existing and new proposed MACT standard, other State, the facility to certify that the only sources. Activated carbon injection has local, or facility-specific programs could materials from motor vehicle scrap are been used on other somewhat similar qualify as a compliance option on a materials recovered for their specialty processes (i.e., similar with respect to case-by-case basis if they met the same alloy, such as chromium in certain temperature and volumetric flow rate); criteria. Consequently, we also are exhaust systems, and that the type of however, it has never been used at EAF proposing as the MACT floor scrap is not reasonably expected to facilities, and thus is not a demonstrated participation in these other programs contain mercury switches. mercury control technology for EAF after satisfying criteria based on the Proposed beyond-the-floor facilities. The nationwide cost of national program, i.e., showing that determination. As a beyond-the-floor activated carbon injection and these other programs would assure the option, we considered the upstream monitoring on EAFs is estimated as same level of mercury control that the removal of mercury-containing $100 million/yr. The mercury national program utilized by the best components other than mercury reductions are estimated as about 5 tpy existing performers achieves, that would switches. There is no practical or after implementation of the national be used by the Administrator to reasonable way to remove trace amounts mercury switch recovery program. determine if other switch removal of mercury entering with raw materials Assuming that activated carbon programs could be used to demonstrate (such as fluxing agents and alloys) other injection could be applied to EAFs and compliance. than scrap. Although there are other would reduce the remaining mercury For example, we are proposing that a components in automobile scrap emissions by 90 percent (4.5 tpy), the facility could prepare and operate containing small amounts of mercury cost effectiveness would be $22 million pursuant to a site-specific plan for the (see the earlier discussion above), pilot per ton of mercury. This cost does not removal of mercury switches and studies by various States have found include the further high cost of waste establish scrap specifications for the that most of the mercury is contributed treatment and disposal noted in the next removal of mercury switches to achieve by the mercury switches, which take paragraph. the MACT level of control (i.e., control only a few minutes to locate and We also considered other factors: (1) as effective as the national plan). The remove. (See the reports of switch The EAF batch process has highly plan would be submitted to the removal studies in Maine, New Jersey, variable concentrations of mercury in Administrator for approval and would and Michigan in the rulemaking the exhaust gases (which results in a demonstrate how the EAF steelmaking docket.) Other mercury-containing great deal of uncertainty with respect to facility will comply with the following components contribute less mercury, cost, design, and efficiency of an add-on specific requirements: (1) A means of and they are more difficult to locate, control system), (2) carbon injection communicating to scrap purchasers and identify, and remove. For example, the could result in landfilling large scrap providers the need to obtain or mercury switch study performed by the quantities of hazardous EAF dust (since provide motor vehicle scrap from which New Jersey Department of the carbon injection residue is mercury switches have been removed Environmental Protection found that commingled with other baghouse dust) and the need to ensure the proper convenience light switches could be that is currently recycled to recover its management of the removed mercury located and removed in less than one zinc value (see American Petroleum switches, (2) provisions for obtaining minute. However, the time to remove Inst. v. EPA, 906 F. 2d 729, 734, 740– assurance from scrap providers that and locate switches in anti-lock braking 41 (D.C. Cir. 1990) and 53 FR 11752– motor vehicle scrap provided to the EAF systems (ABS) required 7 to 8 minutes 11753, August 17, 1988) because the meets the scrap specifications, (3) to locate, remove the rear seat, unbolt mercury would either be re-emitted at provisions for periodic inspection, site the unit, and remove it. In some cases, the zinc smelter (in which case there visits, or other means of corroboration no ABS mercury switches were found. would effectively be no further for the EAF to ensure that scrap Some vehicles had to be raised on lifts, reduction of mercury emissions) or the providers and dismantlers are which required 10 to 15 minutes to baghouse dust which is otherwise

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recyclable would have to be treated and the surrogate pollutant approach based control technologies that would warrant disposed in a RCRA subtitle C landfill on capture and control of PM. subcategorization. Under section (a non-air adverse environmental impact As provided in CAA section 112(d)(5), 112(d)(1) of the CAA, EPA ‘‘may we are required to consider under we are proposing standards representing distinguish among classes, types, and section 112(d)(2)) at a significant cost, GACT for the Urban HAP metals other sizes within a source category or and (3) the operation of a carbon than mercury. EPA believes that the subcategory in establishing such injection (or any type of mercury statute allows the agency to elect to standards * * *’’. We found that there emissions control device) would result establish standards for area sources is a segment of the EAF steelmaking in increased energy consumption listed pursuant to section 112(c) based industry that is comprised of small (another adverse impact we are required on GACT without further explanation. facilities producing specialty and to consider under section 112(d)(2)). The statute simply does not set any stainless steel. These facilities produce Based on the fact that activated condition precedent for issuing less than 150,000 tpy of steel per plant, carbon injection is not a demonstrated standards under section 112(d)(5) other and they represent 0.5 percent of the mercury control technology for EAF than that the area source category or national steelmaking capacity and facilities, the uncertainty in design and subcategory at issue must be one that contribute only 0.5 percent of the HAP performance of the add-on controls and EPA listed pursuant to section 112(c), emissions.21 The EAF process at these hence of the actual mercury emission which is the case here. See 72 FR 38880 small producers is characterized by reductions for EAF facilities, the cost (July 16, 2007). small furnaces with low volume of impacts per ton of emission reduction, We reviewed the control technologies emissions, longer cycle times, and and the adverse energy and solid waste and management practices used by the intermittent rather than continuous impacts, we determined that control existing EAF steelmaking facilities, and operation. In addition, they use high beyond the floor is not warranted for we found that all of the plants are well quality scrap that must meet mercury. Therefore, we are proposing controlled for PM emissions and are specifications much more stringent than that the removal of mercury switches subject to emissions limits for PM. All those applied to scrap for carbon steel from the scrap before it is melted in the plants have capture systems that collect producers. The HAP metals emitted EAF represents MACT for mercury for emissions from charging, melting, from these facilities are primarily new and existing EAF facilities. tapping and ladle metallurgy and route chromium and nickel, whereas carbon the collected gases to a PM control steel producers emit primarily 2. Proposed GACT Standards for Metal device. All plants have title V permits HAP Other Than Mercury manganese and lead. Consequently, we because they are major sources for are proposing to develop GACT Background. EAF steelmaking criteria pollutants (hence the standards standards for two subcategories of EAF facilities were listed under CAA section proposed today would be implemented steelmaking: one for all carbon steel and 112(c)(3) for emissions of the Urban via title V permits). In addition, all large stainless and specialty steel HAP arsenic, cadmium, chromium, plants are subject to the CAM producers and one for small stainless lead, manganese, mercury, and nickel requirements in 40 CFR part 64. and specialty steel producers (i.e., less (67 FR 43112). As just explained in There are a wide variety of capture than 150,000 tpy). section IV.D.2 of this preamble, we are systems and types of control devices Proposed GACT determination for proposing a MACT standard for mercury that EAFs employ to achieve control of carbon steel and large specialty steel based on its listing under CAA section PM, and all of these systems are producers. We examined emission 112(c)(6). For metal HAP other than effective and generally available. For limits in title V permits to determine if mercury, we decided that it is not example, capture systems include GACT for the carbon steel and large practical to establish individual direct-shell evacuation, canopy hoods, specialty steel producers could be standards for each specific type of close-fitting hoods, side draft hoods, expressed in terms of PM emission metallic HAP that could be present in tapping hoods, partial enclosures, total limits for control devices and opacity the emissions (e.g., separate standards enclosures, scavenger duct systems, limits for fugitive emissions from the for manganese emissions, lead building evacuation, or a combination. melt shop. The emission and opacity emissions, and so forth for each of the Control devices include many different limits vary quite widely depending on metals listed as HAP that may be types of baghouses (positive pressure, whether the facility is in a non- present) because the types and negative pressure, reverse air, shaker, attainment area for PM; whether the quantities of metal HAP can vary widely and pulse jet) and venturi scrubbers. We EAF had recently been constructed, in the scrap. When released, each of the concluded from our technology review modified, or reconstructed; EAF age; metallic HAP compounds other than that the generally available control design of the capture and control mercury behaves as PM. The control technologies and management practices system; and other factors. (Details on the technologies used for the control of PM for PM emissions, and thus for permit information are provided in the emissions achieve comparable levels of emissions of HAP metals other than rulemaking docket in the questionnaire performance for these metallic HAP mercury, consist of the installation, responses for each company that was emissions, i.e., when PM is captured, operation, and maintenance of capture surveyed.) The most commonly-applied HAP metals are captured non- and control systems for PM emissions emissions and opacity limits are those preferentially as part of the PM. from charging, melting, tapping, and in the new source performance standard Therefore, emission standards requiring ladle metallurgy. Compliance assurance (NSPS) in 40 CFR part 60, subpart AAa, control of PM will also achieve monitoring under 40 CFR part 64 is which applies to EAFs constructed after comparable control of metallic HAP required for EAF facilities to ensure that August 7, 1983. Approximately 80 of the emissions. Establishing separate the capture and control systems are 91 EAF steelmaking area source standards for each individual type of properly installed, operated, and facilities that we have identified are metallic HAP would impose costly and maintained on a continuing basis. subject to the NSPS. These limits are significantly more complex compliance Subcategories. As part of the GACT and monitoring requirements and analysis, we considered whether there 21 Additional details on the characteristics of the achieve no HAP emissions reductions were differences in processes, sizes, or small specialty steel plants can be found in the beyond what would be achieved using other factors affecting emissions and rulemaking docket.

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0.0052 gr/dscf for the control device and Our economic analysis indicated the possibility of creating a separate a melt shop opacity limit of 6 percent facilities are owned and operated by subcategory for older facilities and (6-minute average) for fugitive large corporations, and all but one of whether these costs are emissions. these corporations operate multiple disproportionately different from those We gathered additional information plants with EAFs. We believe that the of other industry sources. Supporting on the 10 older EAFs in the carbon steel costs of upgrades to meet the NSPS level documentation must be provided in and large specialty steel subcategory of control for opacity are economical sufficient detail to allow that are not subject to the NSPS and and would not pose adverse economic characterization of the quality and found that four facilities are currently impacts on the companies. After representativeness of the data. meeting the NSPS limits and six considering the economic impacts, the We also evaluated the generally facilities are not meeting the NSPS reasonable costs and cost effectiveness available controls and emission limits opacity limit for fugitive emissions. We for control of PM and HAP, and the applied to emissions from control found that the facilities not meeting the emissions reductions that would be devices on EAFs and ladle metallurgy NSPS opacity limit would require either obtained, we have determined initially operations. A total of 80 plants are new or extensively upgraded capture that an opacity limit of 6 percent subject to and achieve the NSPS PM and control equipment to achieve the represented the GACT level of control limit of 0.0052 gr/dscf, and the other 10 level of control required for the newer for this subcategory of carbon steel and plants not subject to the NSPS have facilities subject to the NSPS. We large stainless and specialty steel installed baghouses that can achieve the confirmed that these facilities would producers. limit. Consequently, we are also need higher evacuation rates for their We acknowledge that there is proposing that the PM limit of 0.0052 capture systems and new or expanded uncertainty in our estimates of costs, gr/dscf is GACT for control devices baghouse capacity. We obtained cost emission reductions, and cost applied to EAFs and ladle metallurgy estimates from the plants, and we effectiveness. The estimates of costs and operations. performed our own independent cost effectiveness for the older non- We also considered whether estimates of the cost to upgrade capture NSPS plants could be higher than we additional control and emission and control systems. The total have initially estimated, and if that is reductions might be generally available nationwide capital cost to upgrade to the case and these costs are beyond those achieved by the NSPS. meet the NSPS limit for opacity was disproportionately different from those The NSPS opacity limit of 6 percent is estimated as $26 to $34 million.22 The of other sources, it might be appropriate one of the most stringent Federal limits total annualized cost was estimated as to consider a separate subcategory based in effect for fugitive emissions and is $4.9 to $6.2 million per year on the technical and economic well below the most commonly applied limit of 20 percent for fugitive emissions nationwide. PM emissions would be feasibility (i.e., facilities constructed in State regulations. The NSPS opacity reduced by 540 tpy, and HAP metals prior to 1983 may need to add or alter limit was based on the best-performing other than mercury would be reduced existing infrastructure, upgrade their plants in terms of their ability to capture by 34 tpy. The average cost effectiveness hooding, close vents, install partitions, and control fugitive emissions. A limit per plant ranged from $2,000 to $14,000 or re-route crane ways) of retrofitting 24 more stringent than 6 percent opacity per ton of PM with an overall cost facilities based on their age. If for fugitive emissions has not been effectiveness of $10,000 per ton of PM. subcategorization on this basis is applied to EAFs or other similar For metal HAP other than mercury, the appropriate, we believe that GACT for processes, and any limit more stringent average cost effectiveness per plant these older facilities would achieve an would approach an infeasible standard ranged from $40,000 to $250,000 per ton opacity limit of 6 percent except for 20 percent opacity during charging and of no visible emissions. Consequently, with an overall cost effectiveness of we concluded that an opacity limit of 6 $160,000 per ton of HAP. The cost tapping. This alternative standard would yield an improvement in existing percent is GACT for fugitive emissions effectiveness for PM is well within the from EAF operations. range that EPA has considered performance at reasonable cost. We request comment, along with supporting We also considered whether a PM acceptable for other sources, such as PM limit more stringent than the NSPS limit standards for mobile sources. For documentation, on our estimates of cost and cost effectiveness and the of 0.0052 gr/dscf might be achieved by example, the cost effectiveness of all facilities using the technology mobile source programs adopting (quite described above. Although the NSPS is aggressive) PM controls has ranged from See 5 Legislative History at 8512 (Senate Committee Report) (‘‘[w]hen establishing technology-based 20 years old, it was based on the best $2,390 per ton of PM to $31,530 per ton standards under this subsection, the Administrator technology and best-performing sources of PM with estimates for three mobile may consider the benefits which result from control at that time. The NSPS level of control source programs in the range of $10,000 of air pollutants that are not listed but the emissions is achieved by a well-designed and of which are, nevertheless, reduced by control to $20,000 per ton of PM (69 FR 39133, properly-operated baghouse with a low 23 technologies or practices necessary to meet the June 29, 2004). prescribed limitation’’) air-to-cloth ratio that is characteristic of 24 See Texas Oil and Gas Ass’n v. EPA, 161 F.3d baghouses in use today, and generally 22 The capital cost per plant ranged from $1.5 923, 934 (5th Cir. 1998) (age as subcategorization reflected testing of the baghouses when million to $12 million, and the total annualized cost factor under Clean Water Act); American Iron and per plant ranged from $140,000 to $2.8 million per Steel Inst. v. EPA, 568 F. 2d 244, 299 (3rd Cir. 1977) performing at their optimum. For year. All estimates of impacts (e.g., costs and (same). Here, the year 1983 is critical since EPA example, essentially the same level of emission reductions) are documented in the promulgated new source performance standards PM control (a limit of 0.005 gr/dscf) was rulemaking docket. (NSPS) for the electric arc furnace (EAF) source promulgated as the MACT standard for 23 We note that, although section 112(d) only category in that year. Most of the industry is subject authorizes control of hazardous air pollutants to these standards, but 10 EAFs are not, raising the EAFs and induction furnaces at iron and (HAP), and particulate matter (PM) is not itself a question of whether these sources should be steel foundries, which melt similar HAP but a surrogate for HAP metals, Congress considered as a separate subcategory for purposes scrap and have similar operating expected the maximum achievable control of determining generally available control characteristics (69 FR 21924, April 22, technology (MACT) program to result in significant technology (GACT). See Cf. American Iron and emissions reductions of criteria air pollutants (of Steel Inst. v. EPA, 526 F. 2d 1046, 1048 (3rd Cir. 2004). An upgrade of existing baghouses which PM is one), and viewed this as an important 1975) (age of source may bear on technical and (e.g., increasing bag filtering area to benefit of the MACT (and residual risk) provisions. economic feasibility of retrofitting). lower the air-to-cloth ratio) would result

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in expensive retrofit costs for a very 554, 572 (D.C. Cir. 2002) (1) Summary information on the marginal improvement in PM control. (reasonableness of adopting 99th number, duration and cause (including Consequently, we are proposing that the percentile confidence level); Chemical unknown cause, if applicable) of NSPS PM limit of 0.0052 gr/dscf is Mfr’s. Ass’n v. EPA, 870 F.2d, 229 (5th excursions or exceedances, as GACT for control devices applied to Cir.) (same). We are proposing a PM applicable, and the corrective actions EAFs and ladle metallurgy. emission limit of 0.8 lb/ton of steel taken; (2) summary information on the Proposed GACT determination for produced for this source category of number, duration and cause (including small stainless and specialty steel small stainless and specialty steel unknown cause, if applicable) for producers. We also examined the producers based on the 99th percentile monitor downtime incidents (other than control technologies used by the small of emission control performance downtime associated with zero and stainless and specialty steel producers demonstrated by the venturi scrubber. span or other daily calibration checks, if with a production of less than 150,000 We also examined the control of applicable); and (3) a description of the tpy. We identified five plants in this fugitive emissions at the small stainless actions taken to implement a QIP during subcategory, and all of these plants and specialty steel producers. All of the the reporting period. Upon completion apply capture systems for emissions plants have effective capture and of a QIP, the owner or operator must from charging, melting, tapping, and control systems for fugitive emissions. include in the next summary report ladle metallurgy (i.e., the direct, non- Although two plants are not subject to documentation that the implementation fugitive PM emissions) and vent the the NSPS opacity limit of 6 percent for of the plan has been completed and captured emissions to a PM control fugitive emissions, these plants and all reduced the likelihood of similar levels device. Most plants use baghouses as other plants in the subcategory can meet of excursions or exceedances occurring. the PM control device and meet the the NSPS limit. Consequently, we have We are proposing to adopt the extensive NSPS limit; however, one plant uses a initially determined that the NSPS limit compliance assurance monitoring venturi scrubber as the control device of 6 percent for fugitive emissions from requirements in part 64 in this proposed and meets a PM emission level of 0.8 lb/ the melt shop represented GACT. As we NESHAP for EAF steelmaking facilities. ton of steel produced. We performed an discussed above, the NSPS opacity limit analysis of costs and cost effectiveness of 6 percent is one of the most stringent 3. Proposed GACT Standards for Scrap to determine if the GACT level of limits in effect for fugitive emissions to Control HAP Other Than Mercury emission control for this subcategory and is well below the most commonly In addition to the standards for PM, should be represented by the applied limit of 20 percent for fugitive performance of a baghouse at the NSPS emissions in State regulations. The EPA is proposing further measures to level of control, the level achieved by NSPS opacity limit was based on the minimize the amount of contamination the venturi scrubber, or some other best performing plants in terms of their in scrap to EAFs. Our studies of level. The estimated capital cost to ability to capture and control fugitive industry practices indicate that many replace the venturi scrubber with a emissions. Consequently, we initially facilities have scrap specifications and baghouse ranged from $4 to $14 million concluded that an opacity limit more procedures to minimize contaminants in (depending on retrofit assumptions and stringent than 6 percent for this the scrap. For example, emissions of the their costs) with a total annualized cost subcategory is not warranted and would Urban HAP lead are reduced by of $0.7 to $2 million per year. PM not represent GACT. ensuring that lead components, such as emissions would be reduced by 27 tpy, Proposed compliance monitoring. We wheel weights, batteries, and cables, are and emissions of HAP metals other than are proposing compliance assurance removed before the scrap is processed mercury would be reduced by 4.6 tpy. monitoring as required by 40 CFR part and melted (loosely analogous to the The estimated cost effectiveness was 64 for all EAF steelmaking facilities. mercury switch program discussed for $52,000 per ton of PM and $300,000 per This proposal is based on a review of mercury in that the HAP is removed ton of HAP. We believe that the costs the compliance monitoring procedures from the scrap before it reaches the and cost effectiveness are unacceptably that are currently in place at EAF EAF). Although EAFs were not listed for high and that the emission reductions facilities and are generally available. All emissions of organic Urban HAP, it is achieved would be low (resulting in EAF facilities have title V permits and also common industry practice to limit poor cost effectiveness (which is are subject to the CAM requirements. the amount of plastics and organic certainly higher than those considered The CAM rule requires the owner or liquids in the scrap, which reduces the acceptable in the context just discussed operator to maintain records of emissions of organic HAP. Unlike of fugitive emission control for EAFs). monitoring data, monitor performance mercury, bulky items such as batteries We concluded that the NSPS level of data, corrective actions taken, any and cables, as well as dripping liquids, PM control (0.0052 gr/dscf) does not written QIP, any activities undertaken to can often be visually detected in a scrap represent GACT for this subcategory. implement a QIP, and other supporting load. Consequently, we are proposing Consequently, we reviewed the information required by the part 64 rule pollution prevention measures as GACT emission control performance of the (such as data used to document the for lead and organic HAP. These plant with the venturi scrubber. The adequacy of monitoring, or records of pollution prevention measures reduce results of four tests for PM emissions monitoring maintenance or corrective emissions beyond those achieved by the ranged from 0.4 to 0.7 lb/ton of steel actions). The general reporting emission controls that are already in with an average of 0.5 lb/ton and a requirements of part 64 requires the place. For example, all EAFs have PM standard deviation of 0.11 lb/ton. The owner or operator to submit monitoring control devices, which also control lead 99th percentile of performance (the reports to the permitting authority in emissions; however, preventing lead average plus 2.33 standard deviations) is accordance with the requirements for from entering the EAF provides 0.8 lb/ton. (The 99th percentile is the facilities with title V operating permits, additional reductions even with PM level of emission control that the plant which include a 6-month monitoring controls. Similarly, some organic HAP can achieve at least 99 percent of the report, deviation reports, and annual are destroyed at the high temperatures time, i.e., 99 percent of the test results compliance certifications. The reporting used to melt scrap, but preventing would be below this level.) See National requirements under part 64 require that plastics and organic liquids from Wildlife Federation v. EPA, 286 F.3d the 6-month monitoring report include: entering with the scrap provides

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reductions beyond that achieved by this in the scrap represents GACT (along B. Paperwork Reduction Act thermal destruction. with the emission controls described in The information collection Our survey of EAF plants indicated the previous section of this preamble) requirements in the proposed rule have that all of the plants have specifications because they are in widespread use, been submitted for approval to OMB for their scrap, including measures that there is little additional cost for all under the Paperwork Reduction Act, 44 reduce HAP emissions by preventing plants to implement them (most already U.S.C. 3501 et seq. The Information certain materials from entering the EAF have), and there is no doubt that Collection Request (ICR) document with the scrap. For example, some preventing these materials from entering prepared by EPA has been assigned EPA specify no non-ferrous metals, no non- the EAF will reduce emissions of the ICR No. 2277.02. metallic materials, no free-flowing oil, HAP which would otherwise be charged The proposed information etc. Excluding organic materials (such to the furnace. (A summary of the requirements are based on notification, as plastics and oil) and metals such as proposed scrap management practices is recordkeeping, and reporting lead will reduce HAP emissions, and in provided in section IV.C.4 of this requirements in the NESHAP General the case of organics, also reduce the preamble.) Provisions (40 CFR part 63, subpart A), formation of combustion-product which are mandatory for all operators organic HAP at the high operating V. Impacts of the Proposed Standards subject to national emission standards, temperatures of the EAF. As proposed, the standards would It is difficult to quantify specific and the recordkeeping and reporting reduce mercury emissions from EAF by emissions reductions achieved by these requirements in the part 64 CAM rule, an estimated 5 tons per year (tpy) and scrap management programs. First, which are based on the requirements in would reduce mercury releases to the nearly all plants implement some sort of the operating permits rule (40 CFR parts environment by 8 tpy. The proposed formal or informal scrap management 70 and 71). These recordkeeping and program (to maintain product quality), standards would also reduce emissions reporting requirements are specifically so it is difficult to assess what the of other metallic HAP (primarily authorized by section 114 of the CAA baseline emissions might be without manganese with some lead, nickel and (42 U.S.C. 7414). All information one. Second, these scrap management chromium) by about 34 tpy. Emissions submitted to EPA pursuant to the programs are used in conjunction with of PM would be reduced by 540 tpy. recordkeeping and reporting other air emissions control technologies The capital cost of the proposed requirements for which a claim of to reduce emissions from the EAF. The standards is estimated as $26 to $34 confidentiality is made is safeguarded emissions reductions specifically million. The total annualized cost of the according to Agency policies set forth in attributable to the scrap management proposed rule is estimated at $4.9 to 40 CFR part 2, subpart B. program are impossible to separate out. $6.2 million/yr, including the The proposed rule requires all Nonetheless, it is clear that any annualized cost of capital and the facilities to submit a one-time reduction in HAP content or HAP annual operating costs for emission notification of applicability and precursors entering the EAF will reduce control systems. The additional cost of notification of compliance status the emissions of HAP metals and monitoring, reporting, and required by the NESHAP general organics from the EAF. recordkeeping attributable to the provisions (40 CFR part 63, subpart A). While a scrap management program is proposed rule, including the The notification of compliance status expected to reduce HAP emissions, it preparation of scrap management plans would include compliance certifications cannot be expected to eliminate all HAP and scrap specifications, is estimated as for various rule requirements. The elements or precursors in the scrap. $122,000 per year. No adverse economic general provisions also require First, scrap loads are generally large and impacts are expected for large or small preparation of a test plan for difficult to inspect. A load of scrap may entities. Secondary impacts would performance tests and advance contain thousands of different pieces, include an increase in the generation of notification of the date the performance and some scrap may be shredded and hazardous waste (540 tpy) and an test is to be conducted. bundled. Visual inspections are only increase in electricity usage (10,400 The proposed requirements for the able to identify obvious off-specification megawatt-hours per year) from control of contaminants from scrap materials that are on the top of a load. additional fans and fan capacity require a pollution prevention plan to Second, some of the HAP elements are associated with baghouse installations minimize the amount of chlorinated desirable components in the scrap iron and upgrades to meet the proposed plastics, lead, and free organic liquids and steel that contribute to the overall opacity standard. (All estimates of that are charged to the furnace and chemistry of the product and provide primary and secondary impacts are submit the plan to the Administrator for valuable properties in the cast metal documented in the rulemaking docket.) approval. Facilities must keep the plan (e.g., manganese and chromium.) Third, onsite and train certain employees in even undesirable HAP metals cannot be VI. Statutory and Executive Order the plan’s requirements. Alternatively, eliminated from the cast iron and steel Reviews the facility must restrict the type of as they are trace components in the A. Executive Order 12866: Regulatory scrap charged to the furnace. For scrap iron and steel that cannot be Planning and Review mercury, facilities must prepare a site- separated. For example, all cast iron specific plan for removal of mercury contains trace amounts of lead (typically Under Executive Order 12866 (58 FR switches, submit the plan to the 0.5 to 4 percent). As such, a load of 51735, October 4, 1993), this action is a Administrator for approval, and submit scrap meeting a ‘‘no lead’’ scrap ‘‘significant regulatory action’’ because semiannual progress reports containing specification does not mean that the it may raise novel legal or policy issues. information on the mercury switches scrap is lead-free—only that the scrap is Accordingly, EPA submitted this action that have been removed would also be free of lead components (e.g., batteries to OMB for review under Executive required. Alternatively, facilities must or wheel weights). Order 12866, and any changes made in purchase motor vehicle scrap only from We have determined that the response to OMB recommendations suppliers that participate in an management practice of limiting the have been documented in the docket for approved program for the removal of amount of organic impurities and lead this action. mercury switches or recover only

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material for its specialty alloy content An agency may not conduct or are owned by small businesses (less that does not contain mercury switches. sponsor, and a person is not required to, than 10 percent of the total facilities). Facilities would be required to maintain respond to a collection of information After considering the economic records to demonstrate compliance with unless it displays a currently valid OMB impacts of this proposed rule on small the selected option. Records of specific control number. The OMB control entities, I certify that this action will not information would be required for numbers for EPA’s regulations in 40 have a significant economic impact on plants electing to comply with the site- CFR part 63 are listed in 40 CFR part 9. a substantial number of small entities. specific plan for mercury; semiannual To comment on the Agency’s need for Electric arc furnaces and ladle progress reports would also be required. this information, the accuracy of the metallurgy operations at all EAF All area source facilities would be provided burden estimates, and any steelmaking facilities that are area required to conduct performance tests to suggested methods for minimizing sources are already equipped with demonstrate initial compliance with the respondent burden, including the use of capture systems and control devices. We applicable PM and opacity limits. automated collection techniques, EPA have identified six plants that may have Existing facilities would be allowed to has established a public docket for the to upgrade the capture and control certify initial compliance based on the proposed rule, which includes this ICR, systems for fugitive emissions at a total results of a previous performance test under Docket ID number EPA–HQ– capital cost of $26 to $34 million and a that meets the rule requirements. All OAR–2004–0083. Submit any comments total annualized cost of $4.9 to $6.2 facilities would be required to monitor related to the ICR for the proposed rule million per year. However, none of capture systems and PM control devices to EPA and OMB. See the ADDRESSES these plants are owned by small for EAF and ladle metallurgy section at the beginning of this notice businesses. The only other additional operations, maintain records, and for where to submit comments to EPA. requirements of the proposed NESHAP submit reports according to the part 64 Send comments to OMB at the Office of consist of preparing a scrap selection CAM requirements. These reports Information and Regulatory Affairs, plan or mercury switch removal plan (if include deviation reports, semiannual Office of Management and Budget, 725 these options are selected) and monitoring reports, and annual 17th Street, NW., Washington, DC maintaining records to document compliance certifications. 20503, Attention: Desk Office for EPA. compliance with these requirements. Consistent with § 63.6(e) of the Because OMB is required to make a The requirements of the part 63 General general provisions, all plants would be decision concerning the ICR between 30 Provisions would include notifications, records, semiannual reports, and a required to prepare and operate by a and 60 days after September 20, 2007, startup, shutdown, and malfunction startup, shutdown, and malfunction a comment to OMB is best assured of plan. The information required in these plan, and make an immediate report if having its full effect if OMB receives it information collection requirements are a startup, shutdown, or malfunction was by October 22, 2007. The final rule will very similar to the information not consistent with their plan. Plants respond to any OMB or public collection requirements in 40 CFR parts also would keep records and make comments on the information collection 64, 70, and 71. The cost of these semiannual reports according to the requirements contained in the proposal. requirements (about $3,500 per year per requirements in § 63.10. C. Regulatory Flexibility Act facility) would not result in an adverse The annual average monitoring, economic impact on any facility, large reporting, and recordkeeping burden for The Regulatory Flexibility Act or small (i.e., the cost is less than one this collection (averaged over the first 3 generally requires an agency to prepare percent of total revenues, even for small years of this ICR) is estimated to total a regulatory flexibility analysis of any businesses). 2,393 labor hours per year at a cost of rule subject to notice and comment Although the proposed rule will not $121,573. This includes 2.7 responses rulemaking requirements under the have a significant economic impact on per year from each of 91 respondents for Administrative Procedure Act or any a substantial number of small entities, an average of about 9.7 hours per other statute unless the agency certifies we nonetheless tried to reduce the response. There are no additional that the rule would not have a impact of the proposed rule on small capital/startup costs or operation and significant economic impact on a entities. We held meetings with maintenance costs associated with the substantial number of small entities. industry trade associations and proposed rule. Small entities include small businesses, company representatives to discuss the Burden means the total time, effort, or small not-for-profit enterprises, and proposed rule and have included financial resources expended by persons small governmental jurisdictions. provisions such as the lb/ton limit for to generate, maintain, retain, or disclose For the purposes of assessing the small facilities that address their or provide information to or for a impacts of this proposed rule on small concerns. We have also proposed to Federal agency. This includes the time entities, small entity is defined as: (1) A include a subcategory based partially on needed to review instructions; develop, small business that meets the Small facility size that allows more acquire, install, and utilize technology Business Administration size standards individualized consideration of EAFs in and systems for the purposes of for small businesses at 13 CFR 121.201 the proposed subcategory, which collecting, validating, and verifying (whose parent company has fewer than include small businesses. We continue information, processing and 1,000 employees for NAICS code to be interested in the potential impacts maintaining information, and disclosing 331111; (2) a small governmental of the proposed action on small entities and providing information; adjust the jurisdiction that is a government of a and welcome comments on issues existing ways to comply with any city, county, town, school district, or related to such impacts. previously applicable instructions and special district with a population of less requirements; train personnel to be able than 50,000; and (3) a small D. Unfunded Mandates Reform Act to respond to a collection of organization that is any not-for-profit Title II of the Unfunded Mandates information; search data sources; enterprise which is independently Reform Act of 1995 (UMRA), Public complete and review the collection of owned and operated and is not Law 104–4, establishes requirements for information; and transmit or otherwise dominant in its field. We estimate that Federal agencies to assess the effects of disclose the information. fewer than 9 EAF steelmaking facilities their regulatory actions on State, local,

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and tribal governments and the private have federalism implications.’’ ‘‘Policies the regulatory action meets both criteria, sector. Under section 202 of the UMRA, that have federalism implications’’ are EPA must evaluate the environmental EPA generally must prepare a written defined in the Executive Order to health or safety effects of the planned statement, including a cost-benefit include regulations that have rule on children, and explain why the analysis, for proposed and final rules ‘‘substantial direct effects on the States, planned regulation is preferable to other with ‘‘Federal mandates’’ that may on the relationship between the national potentially effective and reasonably result in expenditures by State, local, government and the States, or on the feasible alternatives considered by the and tribal governments, in the aggregate, distribution of power and Agency. or to the private sector, of $100 million responsibilities among the various EPA interprets Executive Order 13045 or more in any 1 year. Before levels of government.’’ as applying only to those regulatory promulgating an EPA rule for which a The proposed rule does not have actions that are based on health or safety written statement is needed, section 205 federalism implications. It would not risks, such that the analysis required of the UMRA generally requires EPA to have substantial direct effects on the under section 5–501 of the Executive identify and consider a reasonable States, on the relationship between the Order has the potential to influence the number of regulatory alternatives and national government and the States, or regulation. The proposed rule is not adopt the least costly, most cost- on the distribution of power and subject to the Executive Order because effective, or least burdensome responsibilities among the various it is based on technology performance alternative that achieves the objectives levels of government, as specified in and not on health or safety risks. Executive Order 13132. The proposed of the rule. The provisions of section H. Executive Order 13211: Actions That rule does not impose any requirements 205 do not apply when they are Significantly Affect Energy Supply, on State and local governments. Thus, inconsistent with applicable law. Distribution, or Use Moreover, section 205 allows EPA to Executive Order 13132 does not apply adopt an alternative other than the least to the proposed rule. This proposed rule is not a costly, most cost-effective, or least In the spirit of Executive Order 13132, ‘‘significant energy action’’ as defined in burdensome alternative if the and consistent with EPA policy to Executive Order 13211, ‘‘Actions Administrator publishes with the final promote communications between EPA Concerning Regulations That rule an explanation why that alternative and State and local officials, EPA Significantly Affect Energy Supply, was not adopted. Before EPA establishes specifically solicits comments on this Distribution, or Use’’ (66 FR 28355, May any regulatory requirements that may proposed rule from State and local 22, 2001) because it is not likely to have significantly or uniquely affect small officials. a significant adverse effect on the governments, including tribal supply, distribution, or use of energy. F. Executive Order 13175: Consultation governments, it must have developed Further, we have concluded that the and Coordination With Indian Tribal under section 203 of the UMRA a small proposed rule is not likely to have any Governments government agency plan. The plan must adverse energy effects because only a provide for notifying potentially Executive Order 13175 (65 FR 67249, slight increase in energy requirements affected small governments, enabling November 6, 2000), requires EPA to would occur. develop an accountable process to officials of affected small governments I. National Technology Transfer ensure ‘‘meaningful and timely input by to have meaningful and timely input in Advancement Act the development of EPA regulatory tribal officials in the development of proposals with significant Federal regulatory policies that have tribal Section 12(d) of the National intergovernmental mandates, and implications.’’ The proposed rule does Technology Transfer and Advancement informing, educating, and advising not have tribal implications, as specified Act (NTTAA) of 1995 (Public Law No. small governments on compliance with in Executive Order 13175. It would not 104–113, 15 U.S.C. 272 note) directs the regulatory requirements. have substantial direct effects on tribal EPA to use voluntary consensus The EPA has determined that the governments, on the relationship standards (VCS) in its regulatory proposed rule does not contain a between the Federal government and activities, unless to do so would be Federal mandate that may result in Indian tribes, or on the distribution of inconsistent with applicable law or expenditures of $100 million or more power and responsibilities between the otherwise impractical. The VCS are for State, local, and tribal governments, Federal government and Indian tribes, technical standards (e.g., materials in the aggregate, or to the private sector as specified in Executive Order 13175. specifications, test methods, sampling in any one year. Thus, the proposed rule The proposed rule imposes no procedures, and business practices) that is not subject to the requirements of requirements on tribal governments. are developed or adopted by VCS sections 202 and 205 of the UMRA. In Thus, Executive Order 13175 does not bodies. The NTTAA directs EPA to addition, the proposed rule does not apply to the proposed rule. provide Congress, through OMB, significantly or uniquely affect small EPA specifically solicits additional explanations when the Agency does not governments. The proposed rule comment on this proposed rule from use available and applicable VCS. contains no requirements that apply to tribal officials. This proposed rule involves technical such governments and impose no standards. EPA is proposing to use EPA G. Executive Order 13045: Protection of obligations upon them, and the Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, Children From Environmental Health proposed rule is not subject to section 3, 3A, 3B, 4, 5, 5D, and 9 in 40 CFR part and Safety Risks 203 of the UMRA. 60, appendix A; EPA Method 9095B, Executive Order 13045 (62 FR 19885, ‘‘Paint Filter Liquids Test,’’ in ‘‘Test E. Executive Order 13132: Federalism April 23, 1997) applies to any rule that: Methods for Evaluating Solid Waste, Executive Order 13132 (64 FR 43255, (1) Is determined to be ‘‘economically Physical/Chemical Methods,’’ EPA August 10, 1999) requires EPA to significant,’’ as defined under Executive Publication SW–846, revision 2 and develop an accountable process to Order 12866, and (2) concerns an subsequent revisions, dated November ensure ‘‘meaningful and timely input by environmental health or safety risk that 2004 and in Update IIIB (incorporated State and local officials in the EPA has reason to believe may have a by reference in 63.10692—see 40 CFR development of regulatory policies that disproportionate effect on children. If 63.14); and ASTM D2216–05 and

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subsequent revisions, ‘‘Standard Test human health or environmental effects subsequent revisions), dated November Methods for Laboratory Determination on minority or low-income populations 2004 and in Update IIIB, IBR approved of Water (Moisture) Content of Soil and because it increases the level of for § 63.10692. Rock by Mass’’, incorporated by environmental protection for all affected * * * * * reference approved for § 63.10692. populations without having any 3. Part 63 is amended by adding Consistent with the NTTAA, EPA disproportionately high and adverse subpart YYYYY to read as follows: conducted searches to identify VCS in human health or environmental effects addition to these EPA methods. No Subpart YYYYY—National Emission on any population, including any Standards for Hazardous Air Pollutants for applicable VCS were identified for EPA minority or low-income population. Area Sources: Electric Arc Furnace Methods 1A, 2A, 2D, 2F, 2G, 5D, 9, This proposed rule establishes national Steelmaking Facilities 9095B, or ASTM D2216–05. The search standards for the area source category. and review results are in the docket for Applicability and Compliance Dates these proposed rules. List of Subjects in 40 CFR Part 63 Sec. One voluntary consensus standard Environmental protection, Air 63.10680 Am I subject to this subpart? was identified as applicable to this pollution control, Hazardous 63.10681 What are my compliance dates? proposed rule. The standard ASME PTC substances, Reporting and Standards and Compliance Requirements 19.10–1981, ‘‘Flue and Exhaust Gas recordkeeping requirements. 63.10685 What are the requirements for the Analyses,’’ is cited in this proposed rule Dated: September 12, 2007. control of contaminants from scrap? for its manual method for measuring the Stephen L. Johnson, 63.10686 What are the requirements for oxygen, carbon dioxide, and carbon electric arc furnaces and ladle metallurgy monoxide content of the exhaust gas. Administrator. operations? For the reasons stated in the This part of ASME PTC 19.10–1981 is Other Requirements and Information an acceptable alternative to EPA Method preamble, title 40, chapter I, part 63 of the Code of Federal Regulations is 63.10690 What parts of the General 3B. Provisions apply to me? The search for emissions proposed to be amended as follows: 63.10691 Who implements and enforces measurement procedures identified 12 this subpart? other VCS. The EPA determined that PART 63—[AMENDED] 63.10692 What definitions apply to this these 12 standards identified for 1. The authority citation for part 63 subpart? measuring emissions of the HAP or continues to read as follows: Tables to Subpart YYYYY of Part 63 surrogates subject to emissions standards in this proposed rule were Authority: 42 U.S.C. 7401 et seq. Table 1 to Subpart YYYYY of Part 63— Applicability of General Provisions to impractical alternatives to EPA test Subpart YYYYY methods. Therefore, EPA does not Subpart A—[AMENDED] intend to adopt these standards for this 2. Section 63.14 is amended as Subpart YYYYY—National Emission purpose. The reasons for the follows: Standards for Hazardous Air Pollutants determinations for the 12 methods are a. By adding paragraph (b)(63); for Area Sources: Electric Arc Furnace discussed in a memorandum included b. By revising paragraph (i)(1); and Steelmaking Facilities in the docket for this proposed rule. c. By adding paragraph (k)(1)(iv). For the methods required or Applicability and Compliance Dates § 63.14 Incorporations by reference. referenced by this proposed rule, a § 63.10680 Am I subject to this subpart? source may apply to EPA for permission * * * * * (a) You are subject to this subpart if to use alternative test methods or (b) * * * you own or operate an electric arc alternative monitoring requirements in (63) ASTM D2216–05 and subsequent furnace (EAF) steelmaking facility that place of any required testing methods, revisions, ‘‘Standard Test Methods for is an area source of hazardous air performance specifications, or Laboratory Determination of Water pollutant (HAP) emissions. procedures under § 63.7(f) and § 63.8(f) (Moisture) Content of Soil and Rock by Mass’’, IBR approved for § 63.10692. (b) This subpart applies to each new of subpart A of the General Provisions. or existing affected source. The affected * * * * * J. Executive Order 12898: Federal (i) * * * source is each EAF steelmaking facility. Actions To Address Environmental (1) ANSI/ASME PTC 19.10–1981, (1) An affected source is existing if Justice in Minority Populations and ‘‘Flue and Exhaust Gas Analyses [Part you commenced construction or Low-Income Populations 10, Instruments and Apparatus],’’ IBR reconstruction of the affected source on Executive Order 12898 (59 FR 7629, approved for §§ 63.309(k)(1)(iii), or before September 20, 2007. (2) An affected source is new if you February 16, 1994) establishes Federal 63.865(b), 63.3166(a)(3), commenced construction or executive policy on environmental 63.3360(e)(1)(iii), 63.3545(a)(3), reconstruction of the affected source justice. Its main provision directs 63.3555(a)(3), 63.4166(a)(3), after September 20, 2007. Federal agencies, to the greatest extent 63.4362(a)(3), 63.4766(a)(3), (c) This subpart does not apply to practicable and permitted by law, to 63.4965(a)(3), 63.5160(d)(1)(iii), research and development facilities, as make environmental justice part of their 63.9307(c)(2), 63.9323(a)(3), 63.10702, defined in section 112(c)(7) of the Clean mission by identifying and addressing, 63.11148(e)(3)(iii), 63.11155(e)(3), Air Act (CAA). as appropriate, disproportionately high 63.11162(f)(3)(iii) and (f)(4), (d) If you own or operate an area and adverse human health or 63.11163(g)(1)(iii) and (g)(2), source subject to this subpart, you must environmental effects of their programs, 63.11410(j)(1)(iii, and Table 5 to subpart obtain a permit under 40 CFR part 70 or policies, and activities on minority DDDDD of this part. 40 CFR part 71. populations and low-income * * * * * populations in the United States. (k) * * * § 63.10681 What are my compliance EPA has determined that this (1) * * * dates? proposed rule will not have (iv) Method 9095B, ‘‘Paint Filter (a) Except as provided in paragraph disproportionately high and adverse Liquids Test,’’ (revision 2 and (b) of this section, if you own or operate

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an existing affected source, you must plan onsite, and you must provide options in paragraphs (b)(1), (2), or (3) achieve compliance with the applicable training on the plan’s requirements to of this section. You may have one scrap provisions of this subpart by no later all plant personnel with materials provider, contract, or shipment subject than 6 months after the date of acquisition or inspection duties. Each to one compliance option and others publication of the final rule in the plan must include the information in subject to another option. Federal Register. paragraphs (a)(1) (i) through (iii) of this (1) Site-specific plan for mercury (b) If you own or operate an existing section: switches. You must comply with the affected source, you must achieve (i) Specifications that scrap materials requirements in paragraphs (b)(1)(i) compliance with the opacity limit in must be depleted (to the extent through (v) of this section. § 63.10686 (b)(2) or (c)(2) by no later practicable) of undrained used oil (i) You must include a requirement in than 2 years after the date of publication filters, chlorinated plastics, and free your scrap specifications for removal of of the final rule in the Federal Register organic liquids at the time of charging mercury switches from vehicle bodies if you demonstrate to the satisfaction of to the furnace. used to make the scrap. the permitting authority that additional (ii) A requirement in your scrap (ii) You must prepare and operate time is needed to install or modify specifications for removal (to the extent according to a plan demonstrating how emission control equipment. practicable) of lead-containing your facility will implement the scrap (c) If you start up a new affected components (such as batteries, battery specification in paragraph (b)(1)(i) of source on or before the date of date of cables, and wheel weights) from the this section for removal of mercury publication of the final rule in the scrap according to standard industry switches. You must submit the plan to Federal Register, you must achieve practice, except for scrap used to the Administrator for approval. The compliance with the applicable produce leaded steel. Administrator may change the approval (iii) Procedures for determining if the provisions of this subpart by no later status of the plan upon 90-days written requirements and specifications in than the date of publication of the final notice based upon the semiannual paragraph (a)(1) of this section are met rule in the Federal Register. compliance report or other information. (such as visual inspection or periodic (d) If you start up a new affected The plan must include: audits of scrap providers) and source after the date of publication of procedures for taking corrective actions (A) A means of communicating to the final rule in the Federal Register, with vendors whose shipments are not scrap purchasers and scrap providers you must achieve compliance with the within specifications. the need to obtain or provide motor applicable provisions of this subpart (iv) The requirements of paragraph vehicle scrap from which mercury upon startup of your affected source. (a)(1) of this section do not apply to the switches have been removed and the Standards and Compliance routine recycling of baghouse bags or need to ensure the proper management Requirements other internal process or maintenance of the mercury switches removed from materials in the furnace. that scrap as required under the rules § 63.10685 What are the requirements for (2) Restricted metallic scrap. For the implementing subtitle C of the Resource the control of contaminants from scrap? production of steel other than leaded Conservation and Recovery Act (RCRA) (a) Chlorinated plastics, lead, and free steel, you must not charge to a furnace (40 CFR parts 261 through 265 and 268); organic liquids. For metallic scrap metallic scrap that contains scrap from (B) Provisions for obtaining assurance utilized in the EAF at your facility, you motor vehicle bodies, engine blocks, oil from scrap providers that motor vehicle must comply with the requirements in filters, oily turnings, machine shop scrap provided to the facility meet the either paragraph (a)(1) or (2) of this borings, transformers or capacitors scrap specification; section. You may have certain scrap at containing polychlorinated biphenyls, (C) Provisions for periodic inspection, your facility subject to paragraph (a)(1) lead-containing components, site visits, or other means of of this section and other scrap subject to chlorinated plastics, or free organic corroboration to ensure that scrap paragraph (a)(2) of this section provided liquids. For the production of leaded providers and dismantlers are the scrap remains segregated until steel, you must not charge to the furnace implementing appropriate steps to charge make-up. metallic scrap that contains scrap from minimize the presence of mercury (1) Pollution prevention plan. For the motor vehicle bodies, engine blocks, oil switches in motor vehicle scrap and that production of steel other than leaded filters, oily turnings, machine shop the mercury switches removed are being steel, you must prepare and implement borings, transformers or capacitors properly managed, including the a pollution prevention plan for metallic containing polychlorinated biphenyls, minimum frequency such means of scrap selection and inspection to chlorinated plastics, or free organic corroboration will be implemented; and minimize the amount of chlorinated liquids. This restriction does not apply (D) Provisions for taking corrective plastics, lead, and free organic liquids to any post-consumer engine blocks, actions (i.e., actions resulting in scrap that is charged to the furnace. For the post-consumer oil filters, or oily providers removing a higher percentage production of leaded steel, you must turnings that are processed or cleaned to of mercury switches or other mercury- prepare and implement a pollution the extent practicable such that the containing components) if needed, prevention plan for scrap selection and materials do not include lead based on the results of procedures inspection to minimize the amount of components, chlorinated plastics, or implemented in paragraph (b)(1)(ii)(C) chlorinated plastics and free organic free organic liquids. This restriction of this section). liquids in the scrap that is charged to does not apply to motor vehicle scrap (iii) You must require each motor the furnace. The requirements for a that is charged to recover the chromium vehicle scrap provider to provide an pollution prevention plan do not apply or nickel content if you meet the estimate of the number of mercury to the routine recycling of baghouse requirements in paragraph (b)(3) of this switches removed from motor vehicle bags or other internal process or section. scrap sent to your facility during the maintenance materials in the furnace. (b) Mercury requirements. For each previous year and the basis for the You must submit the scrap pollution scrap provider, contract, or shipment, estimate. The Administrator may prevention plan to the Administrator for you must procure all motor vehicle request documentation or additional approval. You must keep a copy of the scrap pursuant to one of the compliance information at any time.

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(iv) You must establish a goal for each systems, active ride control, and other an estimate of the percent of mercury scrap provider to remove at least 80 applications) when evaluating progress switches recovered, and certification percent of the mercury switches. towards the 80 percent goal; and that the recovered mercury switches Although a site-specific plan approved (iii) The program sponsor agrees to were recycled at RCRA-permitted under paragraph (b)(1) of this section submit progress reports to the facilities. The semiannual reports must may require only the removal of Administrator no less frequently than include a certification that you have convenience light switch mechanisms, once every year that provide the number conducted inspections, site visits, or the Administrator will credit all of mercury switches removed or the taken other means of corroboration as documented and verifiable mercury- weight of mercury recovered from the required under paragraph (b)(1)(ii)(C) of containing components removed from switches, the estimated number of this section. You may include this motor vehicle scrap (such as sensors in vehicles processed, an estimate of the information in the semiannual anti-locking brake systems, security percent of mercury switches recovered, compliance reports required under systems, active ride control, and other and certification that the recovered paragraph (c)(3) of this section. applications) when evaluating progress mercury switches were recycled at (2) If you are subject to the option for towards the 80 percent goal. facilities with permits as required under approved mercury programs under (v) For each scrap provider, you must the rules implementing subtitle C of paragraph (b)(2) of this section, you submit semiannual progress reports to RCRA (40 CFR parts 261 through 265 must maintain records identifying each the Administrator that provide the and 268). The progress reports must be scrap provider and documenting the number of mercury switches removed or based on a database that includes data scrap provider’s participation in an the weight of mercury recovered from for each program participant; however, approved mercury switch removal the switches, the estimated number of data may be aggregated at the State level program. vehicles processed, an estimate of the for progress reports that will be publicly (3) You must submit semiannual percent of mercury switches removed, available. The Administrator may compliance reports to the Administrator and certification that the removed change the approval status of a program for the control of contaminants from mercury switches were recycled at or portion of a program (e.g., at the State scrap according to the requirements in RCRA-permitted facilities or otherwise level) following 90-days notice based on § 63.10(e). The report must clearly properly managed pursuant to RCRA the progress reports or on other identify any deviation from the subtitle C regulations referenced in information. requirements in paragraphs (a) and (b) paragraph (b)(1)(A) of this section. The (3) Option for specialty metal scrap. of this section and the corrective action Administrator may change the approval You must certify in your notification of taken. You must identify which status of a site-specific plan following compliance status that the only compliance option in paragraph (b) of 90-days notice based on the progress materials from motor vehicles in the this section applies to each scrap reports or other information. scrap are materials recovered for their provider, contract, or shipment. (2) Option for approved mercury specialty alloy (including, but not programs. You must certify in your limited to, chromium, nickel, § 63.10686 What are the requirements for notification of compliance status that molybdenum, or other alloys) content electric arc furnaces and ladle metallurgy you participate in and purchase motor (such as certain exhaust systems) and, operations? vehicle scrap only from scrap providers based on the nature of the scrap and (a) You must install, operate, and who participate in a program for purchase specifications, that the type of maintain a capture system that collects removal of mercury switches that has scrap is not reasonably expected to the gases and fumes from each EAF been approved by the Administrator contain mercury switches. (including charging, melting, and based on the criteria in paragraphs (c) Recordkeeping and reporting tapping operations) and ladle (b)(2)(i) through (iii) of this section. The requirements. (1) In addition to the metallurgy operation and conveys the National Vehicle Mercury Switch records required by § 63.10, you must collected gas stream to a control device Recovery Program is an EPA-approved keep records to demonstrate compliance for the removal of particulate matter program under paragraph (b)(2) of this with the requirements for your pollution (PM). section unless and until the prevention plan in paragraph (a)(1) of (b) Except as provided in paragraph Administrator disapproves the program this section and/or for the use of only (c) of this section, you must not (in part or in whole) under paragraph restricted scrap in paragraph (a)(2) of discharge or cause the discharge into the (b)(2)(iii) of this section. this section and for mercury in atmosphere from an EAF or ladle (i) The program includes outreach paragraph (b)(1) of this section, metallurgy operation any gases which: that informs the dismantlers of the need including any compliance options in (1) Exit from a control device and for removal of mercury switches and paragraphs (b)(2) and (3) of this section. contain in excess of 0.0052 grains of PM provides training and guidance for (1) If you are subject to the per dry standard cubic foot (gr/dscf); removing mercury switches; requirements for a site-specific plan for and (ii) The program has a goal for each mercury under paragraph (b)(1) of this (2) Exit from a melt shop and, due scrap provider which is a party to the section, you must: solely to the operations of any affected agreement to remove at least 80 percent (i) Maintain records of the number of EAF(s) or ladle metallurgy operation(s), of mercury switches from the motor mercury switches removed or the exhibit 6 percent opacity or greater. vehicle scrap the scrap provider weight of mercury recovered from the (c) If you own or operate a new or processes. Although a program switches and properly managed, the existing affected source that produces approved under paragraph (b)(2) of this estimated number of vehicles processed, less than 150,000 tons per year (tpy) of section may require only the removal of and an estimate of the percent of stainless or specialty steel, you must not convenience light switch mechanisms, mercury switches recovered; and discharge or cause the discharge into the the Administrator will credit all (ii) Submit semiannual reports of the atmosphere from an EAF or ladle documented and verifiable mercury- number of mercury switches removed or metallurgy operation any gases which: containing components removed from the weight of mercury recovered from (1) Exit from a control device and motor vehicle scrap (such as sensors in the switches and properly managed, the contain in excess of 0.8 pounds of PM anti-locking brake systems, security estimated number of vehicles processed, per ton (lb/ton) of steel; and

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(2) Exit from a melt shop and, due procedures that will be used to the approved plan by no later than 180 solely to the operations of any affected determine compliance for an EAF or days after the date of approval by the EAF(s) or ladle metallurgy operation(s), ladle metallurgy operation when permitting authority. exhibit 6 percent opacity or greater. emissions are combined with those from Other Requirements and Information (d) Except as provided in paragraph facilities not subject to this subpart. (d)(6) of this section, you must conduct (5) To determine compliance with the § 63.10690 What parts of the General performance tests to demonstrate initial PM emissions limit in paragraph (c) of Provisions apply to this subpart? compliance with the applicable this section for an EAF or ladle (a) You must comply with the emissions limit for each emissions metallurgy operation in a lb/ton of steel requirements of the NESHAP General source subject to an emissions limit in format, compute the process-weighted Provisions (40 CFR part 63, subpart A) paragraph (b) or (c) of this section. mass emissions (Ep) for each test run as provided in Table 1 of this subpart. (1) You must conduct each PM using Equation 1 of this section: (b) The notification of compliance performance test for an EAF or ladle status required by § 63.9(h) must metallurgy operation according to the CQT×× E = (Eq . 1) include each applicable certification of procedures in § 63.7 and 40 CFR p PK× compliance, signed by a responsible 60.275a using the following test official, in paragraphs (b)(1) through (6) methods in 40 CFR part 60, appendices Where: Ep = Process-weighted mass emissions of PM, of this section. A–1, A–2, A–3, and A–4: (1) For the pollution prevention plan (i) Method 1 or 1A of Appendix lb/ton; C = Concentration of PM or total metal HAP, requirements in § 63.10685(a)(1): ‘‘This A–1 of 40 CFR part 60 to select gr/dscf; facility has submitted a pollution sampling port locations and the number Q = Volumetric flow rate of stack gas, dscf/ prevention plan for metallic scrap of traverse points in each stack or duct. hr; selection and inspection in accordance Sampling sites must be located at the T = Total time during a test run that a sample with § 63.10685(a)(1)’’; outlet of the control device (or at the is withdrawn from the stack during steel production cycle, hr; (2) For the restrictions on metallic outlet of the emissions source if no scrap in § 63.10685(a)(2): ‘‘This facility control device is present) prior to any P = Total amount of metal produced during the test run, tons; and complies with the requirements for releases to the atmosphere. K = Conversion factor, 7,000 grains per restricted metallic scrap in accordance (ii) Method 2, 2A, 2C, 2D, 2F, or 2G pound. with § 63.10685(a)(2)’’; of Appendix A–1 of 40 CFR part 60 to (3) For the mercury requirements in determine the volumetric flow rate of (6) If you own or operate an existing § 63.10685(b): the stack gas. affected source that is subject to the (iii) Method 3, 3A, or 3B of Appendix emissions limits in paragraph (b) or (c) (i) ‘‘This facility has prepared a site- A–2 of 40 CFR part 60 to determine the of this section, you may certify initial specific plan for mercury switches in dry molecular weight of the stack gas. compliance for one or more emissions accordance with § 63.10685(b)(1)’’; You may use ANSI/ASME PTC 19.10– sources based on the results of a (ii) ‘‘This facility participates in and 1981, ‘‘Flue and Exhaust Gas Analyses previous performance test for that purchases motor vehicle scrap only (incorporated by reference—see § 63.14) emissions source in lieu of the from scrap providers who participate in as an alternative to EPA Method 3B. requirement for an initial performance a program for removal of mercury (iv) Method 4 of Appendix A–3 of 40 test provided that the test(s) were switches that has been approved the CFR part 60 to determine the moisture conducted within 5 years of the EPA Administrator in accordance with content of the stack gas. compliance date using the methods and § 63.10685(b)(2)’’; or (v) Method 5 or 5D of Appendix procedures specified in paragraph (d)(1) (iii) ‘‘The only materials from motor A–3 of 40 CFR part 60 to determine the or (2) of this section; the test(s) were for vehicles in the scrap charged to an PM concentration. Three valid test runs the affected facility; and the test(s) were electric arc furnace at this facility are are needed to comprise a PM representative of current or anticipated materials recovered for their specialty performance test. For EAF, sample only operating processes and conditions. alloy content in accordance with when metal is being melted and refined. Should the permitting authority deem § 63.10685(b)(3) which are not For ladle metallurgy operations, sample the prior test data unacceptable, the reasonably expected to contain mercury only when the operation(s) are being owner or operator must conduct an switches’’. conducted. initial performance test within 180 days (4) This certification of compliance (2) You must conduct each opacity of the rule compliance date. for the capture system requirements in test for a melt shop according to the (e) You must monitor the capture § 63.10686(a), signed by a responsible procedures in § 63.6(h) and Method 9 of system and PM control device required official: ‘‘This facility operates a capture Appendix A–4 of 40 CFR part 60. When by this subpart, maintain records, and system for each electric arc furnace and emissions from any EAF or ladle submit reports according to the ladle metallurgy operation that conveys metallurgy operation are combined with compliance assurance monitoring the collected gas stream to a PM control emissions from emission sources not requirements in 40 CFR part 64. The device in accordance with subject to this subpart, you must exemption in 40 CFR 64.2(b)(1)(i) for § 63.10686(a)’’. demonstrate compliance with the melt emissions limitations or standards (5) If applicable, this certification of shop opacity limit based on emissions proposed after November 15, 1990 compliance for the performance test from only the emission sources subject under section 111 or 112 of the CAA requirements in § 63.10686(d)(6): ‘‘This to this subpart. does not apply. In lieu of the deadlines facility certifies initial compliance with (3) During any performance test, you for submittal in 40 CFR 64.5, you must the applicable emissions limit in must monitor and record the submit the monitoring information § 63.10686(a) or (b) based on the results information specified in 40 CFR required by 40 CFR 64.4 to the of a previous performance test in 60.274a(h) for all heats covered by the applicable permitting authority for accordance with § 63.10686(d)(6)’’. test. approval by no later than the (6) This certification of compliance (4) You must notify, and receive compliance date for your affected source for the monitoring requirements in approval from the Administrator for for this subpart and operate according to § 63.10686(e), signed by a responsible

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official: ‘‘This facility has developed Chlorinated plastics means solid period, the material contains free and submitted proposed monitoring polymeric materials that contain organic liquids. information in accordance with 40 CFR chlorine in the polymer chain, such as Ladle metallurgy means a steelmaking part 64’’. polyvinyl chloride (PVC) and PVC process that is performed typically in a copolymers. ladle after initial refining in an electric § 63.10691 Who implements and enforces this subpart? Control device means the air pollution arc furnace, including argon-oxygen control equipment used to remove decarburization, alloy addition, (a) This subpart can be implemented particulate matter from the effluent gas temperature adjustment, and other and enforced by the EPA or a delegated stream generated by an electric arc processes that adjust or amend the authority such as a State, local, or tribal furnace or ladle metallurgy operation(s). chemical and/or mechanical properties agency. If the EPA Administrator has of steel. This definition does not include delegated authority to a State, local, or Deviation means any instance where vacuum degassing. tribal agency, then that Agency has the an affected source subject to this authority to implement and enforce this subpart, or an owner or operator of such Leaded steel means steel that must subpart. You should contact your EPA a source: meet a minimum specification for lead Regional Office to find out if this (1) Fails to meet any requirement or content (typically 0.25 percent or more) subpart is delegated to your State, local, obligation established by this subpart, and for which lead is a necessary alloy or tribal agency. including but not limited to any for that grade of steel. (b) In delegating implementation and emissions limitation or work practice Mercury switch means each mercury- enforcement authority of this subpart to standard; containing capsule or switch assembly a State, local, or tribal agency under 40 (2) Fails to meet any term or condition that is part of a convenience light switch CFR part 63, subpart E, the authorities that is adopted to implement an mechanism installed in a vehicle. contained in paragraph (c) of this applicable requirement in this subpart Motor vehicle means an automotive section are retained by the and that is included in the operating vehicle not operated on rails and Administrator and are not transferred to permit for any affected source required usually is operated with rubber tires for the State, local, or tribal agency. to obtain such a permit; or use on highways. (c) The authorities that will not be (3) Fails to meet any emissions Motor vehicle scrap means vehicle or delegated to State, local, or tribal limitation in this subpart during startup, automobile bodies, including agencies are listed in paragraphs (c)(1) shutdown, or malfunction, regardless of automobile body hulks, that have been through (3) of this section. whether or not such failure is permitted processed through a shredder. Motor (1) Approval of a major change to test by this subpart. vehicle scrap does not include methods under § 63.7(e)(2)(ii) and (f). A Electric arc furnace (EAF) means a automobile manufacturing bundles, or ‘‘major change to test method’’ is furnace that produces molten steel and miscellaneous vehicle parts, such as defined in 40 CFR 63.90. heats the charge materials with electric wheels, bumpers or other components (2) Approval of major change to arcs from carbon electrodes. An electric that do not contain mercury switches. monitoring under 40 CFR 63.8(f). A arc furnace consists of the furnace shell, Scrap provider means the person ‘‘major change to monitoring’’ is defined roof, and the transformer. (including a broker) who contracts in 40 CFR 63.90. Electric arc furnace (EAF) steelmaking directly with a steel mill to provide (3) Approval of a major change to facility means a steel plant that motor vehicle scrap. Scrap processors recordkeeping/reporting under 40 CFR produces carbon, alloy, or specialty such as shredder operators or vehicle 63.10(f). A ‘‘major change to steels using an EAF. This definition dismantlers that do not sell scrap recordkeeping/reporting’’ is defined in excludes EAF steelmaking facilities at directly to a steel mill are not scrap 40 CFR 63.90. steel foundries. providers. § 63.10692 What definitions apply to this Free organic liquids means material Specialty steel means low carbon and subpart? that fails the paint filter test by EPA high alloy steel other than stainless steel Terms used in this subpart are Method 9095B (incorporated by that is processed in an argon-oxygen defined in the Clean Air Act, in § 63.2, reference—see 40 CFR 63.14) after decarburization vessel. and in this section as follows: accounting for water using a moisture Stainless steel means low carbon steel Capture system means the equipment determination test by ASTM Method that contains at least 10.5 percent (including ducts, hoods, fans, dampers, D2216–05 or subsequent versions chromium. etc.) used to capture or transport (incorporated by reference-see 40 CFR As required in § 63.10691(a), you particulate matter generated by an 63.14). If, after conducting a moisture must comply with the requirements of electric arc furnace or ladle metallurgy determination test, any portion of the the NESHAP General Provisions (40 operation to the air pollution control material passes through and drops from CFR part 63, subpart A) shown in the device. the filter within the 5-minute test following table:

TABLE 1 TO SUBPART YYYYY OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART YYYYY

Applies to Citation Subject Subpart Explanation YYYYY?

§ 63.1(a)(1), (a)(2), (a)(3), (a)(4), (a)(6), Applicability ...... Yes. (a)(10)–(a)(12), (b)(1), (b)(3), (c)(1), (c)(2), (c)(5), (e). § 63.1(a)(5), (a)(7)–(a)(9), (b)(2), (c)(3), Reserved ...... No. (c)(4), (d). § 63.2 ...... Definitions ...... Yes. § 63.3 ...... Units and Abbreviations ...... Yes. § 63.4 ...... Prohibited Activities and Circumvention Yes.

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TABLE 1 TO SUBPART YYYYY OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART YYYYY—Continued

Applies to Citation Subject Subpart Explanation YYYYY?

§ 63.5 ...... Preconstruction Review and Notification Yes. Requirements. § 63.6(a), (b)(1)–(b)(5), (b)(7), (c)(1), Compliance with Standards and Mainte- Yes. (c)(2), (c)(5), (e)(1), (e)(3)(i), (e)(3)(iii)– nance Requirements. (e)(3)(ix), (f), (g), (h)(1), (h)(2), (h)(5)– (h)(9), (i), (j). § 63.6(b)(6), (c)(3), (c)(4), (d), (e)(2), Reserved ...... No. (e)(3)(ii), (h)(3), (h)(5)(iv). § 63.7 ...... Applicability and Performance Test Yes. Dates. § 63.8(a)(1), (a)(2), (b), (c), (d),(e), Monitoring Requirements ...... Yes ...... Requirements in § 63.8(c)(4)(i)–(ii), (f)(1)–(5), (g). (c)(5) and (c)(6), (d), (e), and (g) apply if a COMS or CEMS is used. § 63.8(a)(3) ...... [Reserved] ...... No. § 63.8(a)(4) ...... Additional Monitoring Requirements for No. Control Devices in § 63.11. § 63.8(c)(4) ...... Continuous Monitoring System Require- Yes ...... Requirements apply if a COMS or ments. CEMS is used. § 63.8(f)(6) ...... RATA Alternative ...... Yes ...... Requirements apply if a CEMS is used. § 63.9(a), (b)(1), (b)(2), (b)(5), (c), (d), Notification Requirements ...... Yes. (f), (g), (h)(1)–(h)(3), (h)(5), (h)(6), (i), (j). § 63.9(b)(3), (h)(4) ...... Reserved ...... No. § 63.9(b)(4) ...... No. § 63.10(a), (b)(1), (b)(2)(i)–(v), (b)(2)(xiv), Recordkeeping and Reporting Require- Yes ...... Additional records for CMS in § 63.10(c) (b)(3), (c)(1), (c)(5)–(c)(8), (c)(10)– ments. (1)–(6), (9)–(15), and reports in (c)(15), (d), (e)(1)–(e)(4), (e)(4), (f). § 63.10(d)(1)–(2) apply if a COMS or CEMS is used. § 63.10(b)(2)(xiii) ...... CMS Records for RATA Alternative ...... Yes ...... Requirements apply if a CEMS is used. § 63.10(c)(2)–(c)(4), (c)(9) ...... Reserved ...... No. § 63.11 ...... Control Device Requirements ...... No. § 63.12 ...... State Authority and Delegations ...... Yes. § 63.13–63.16 ...... Addresses, Incorporations by Ref- Yes. erence, Availability of Information, Performance Track Provisions.

[FR Doc. E7–18343 Filed 9–19–07; 8:45 am] BILLING CODE 6560–50–P

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Part III

Environmental Protection Agency 40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for Area Sources: Clay Ceramics Manufacturing, Glass Manufacturing, and Secondary Nonferrous Metals Processing; Proposed Rule

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ENVIRONMENTAL PROTECTION provisions to the Office of Information www.regulations.gov or in hard copy at AGENCY and Regulatory Affairs, Office of the EPA Docket Center, Public Reading Management and Budget (OMB), Attn: Room, EPA/DC, EPA West, Room 3334, 40 CFR Part 63 Desk Officer for EPA, 725 17th St., NW., 1301 Constitution Ave., NW., Washington, DC 20503. Washington, DC. The Public Reading [EPA–HQ–OAR–2006–0424; EPA–HQ–OAR– • 2006–0360; EPA–HQ–OAR–2006–0940; Hand Delivery: EPA Docket Center, Room is open from 8:30 a.m. to 4:30 FRL–8469–9] Public Reading Room, EPA West, Room p.m. Eastern Standard Time (EST), 3334, 1301 Constitution Ave., NW., Monday through Friday, excluding legal RIN 2060–AM12 Washington, DC 20460. Such deliveries holidays. The telephone number for the are only accepted during the Docket’s National Emission Standards for Public Reading Room is (202) 566–1744, normal hours of operation, and special Hazardous Air Pollutants for Area and the telephone number for the Air arrangements should be made for Sources: Clay Ceramics Docket is (202) 566–1742. deliveries of boxed information. Manufacturing, Glass Manufacturing, FOR FURTHER INFORMATION CONTACT: For Instructions. Direct your comments to questions about the proposed rule for and Secondary Nonferrous Metals Docket ID No. EPA–HQ–OAR–2006– Processing Clay Ceramics Manufacturing, contact 0424 (for Clay Ceramics Manufacturing), Mr. Bill Neuffer, Office of Air Quality AGENCY: Environmental Protection Docket ID No. EPA–HQ–OAR–2006– Planning and Standards, Sector Policies Agency (EPA). 0360 (for Glass Manufacturing), or and Programs Division, Metals and Docket ID No. EPA–HQ–OAR–2006– ACTION: Proposed rule. Minerals Group (D243–02), 0940 (for Secondary Nonferrous Metals Environmental Protection Agency, Processing). EPA’s policy is that all SUMMARY: EPA is proposing national Research Triangle Park, NC 27711; comments received will be included in emission standards for the Clay telephone number: (919) 541–5435; fax the public docket without change and Ceramics Manufacturing, Glass number: (919) 541–3207; e-mail address: may be made available online at Manufacturing, and Secondary [email protected]. For questions www.regulations.gov, including any Nonferrous Metals Processing area about the proposed rule for Glass personal information provided, unless source categories. The proposed Manufacturing or Secondary Nonferrous the comment includes information emissions standards for new and Metals Processing, contact Ms. Susan claimed to be confidential business existing sources are based on EPA’s Fairchild, Office of Air Quality Planning information (CBI) or other information proposed determination as to what and Standards, Sector Policies and constitutes the generally available whose disclosure is restricted by statute. Do not submit information that you Programs Division, Metals and Minerals control technology or management Group (D243–02), Research Triangle practices for each area source category. consider to be CBI or otherwise protected through www.regulations.gov Park, NC 27711, telephone number: DATES: Comments must be received on or e-mail. The www.regulations.gov (919) 541–5167, fax number: (919) 541– or before October 22, 2007 unless a website is an ‘‘anonymous access’’ 3207, e-mail address: public hearing is requested by October system, which means EPA will not [email protected]. 1, 2007. If a hearing is requested on the know your identity or contact SUPPLEMENTARY INFORMATION: The proposed rules, written comments must information unless you provide it in the supplementary information presented in be received by November 5, 2007. Under body of your comment. If you send an this preamble is organized as follows: the Paperwork Reduction Act, e-mail comment directly to EPA without I. General Information comments on the information collection going through www.regulations.gov, provisions must be received by the A. Does this action apply to me? your e-mail address will be B. What should I consider as I prepare my Office of Management and Budget automatically captured and included as comments to EPA? (OMB) on or before October 22, 2007. part of the comment that is placed in the C. Where can I get a copy of this ADDRESSES: Submit your comments, public docket and made available on the document? identified by Docket ID No. EPA–HQ– Internet. If you submit an electronic D. When would a public hearing occur? OAR–2006–0424 (for Clay Ceramics comment, EPA recommends that you II. Background Information for Proposed Area Manufacturing), Docket ID No. EPA– Source Standards include your name and other contact A. What is the statutory authority for the HQ–OAR–2006–0360 (for Glass information in the body of your proposed NESHAP? Manufacturing), or Docket ID No. EPA– comment and with any disk or CD–ROM B. What criteria did EPA use in developing HQ–OAR–2006–0940 (for Secondary you submit. If EPA cannot read your the proposed NESHAP? Nonferrous Metals Processing) by one of comment due to technical difficulties III. Proposed Area Source NESHAP for Clay the following methods: and cannot contact you for clarification, Ceramics Manufacturing • www.regulations.gov. Follow the EPA may not be able to consider your A. What area source category is affected by on-line instructions for submitting comment. Electronic files should avoid the proposed rule? comments. the use of special characters, any form B. What are the production processes and • emissions points at facilities that E-mail: [email protected]. of encryption, and be free of any defects manufacture clay ceramics? • Fax: (202) 566–9744. or viruses. • C. How did EPA subcategorize spray glaze Mail: National Emission Standards Docket. All documents in the docket operations? for Hazardous Air Pollutants for Area are listed in the www.regulations.gov D. How was GACT determined? Sources: Clay Ceramics Manufacturing, index. Although listed in the index, E. What are the proposed requirements for Glass Manufacturing, and Secondary. some information is not publicly area sources? Nonferrous Metals Processing, available, e.g., CBI or other information IV. Proposed Area Source NESHAP for Glass Environmental Protection Agency, whose disclosure is restricted by statute. Manufacturing Mailcode: 2822T, 1200 Pennsylvania Certain other material, such as A. What area source category is affected by the proposed rule? Ave., NW., Washington, DC 20460. copyrighted material, will be publicly B. What are the production processes and Please include a total of two copies. In available only in hard copy form. emissions points at facilities that addition, please mail a copy of your Publicly available docket materials are manufacture glass? comments on the information collection available either electronically in C. How was GACT determined?

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D. What are the proposed requirements for VII. What are the impacts of the proposed H. Executive Order 13211: Actions area sources? standards for area sources? Concerning Regulations that V. Proposed Area Source NESHAP for VIII. Statutory and Executive Order Significantly Affect Energy Supply, Secondary Nonferrous Metals Processing Reviews Distribution, or Use A. What area source category is affected by A. Executive Order 12866: Regulatory I. National Technology Transfer the proposed rule? Planning and Review Advancement Act J. Executive Order 12898: Federal Actions B. What are the production processes and B. Paperwork Reduction Act emissions points at facilities that process to Address Environmental Justice in C. Regulatory Flexibility Act secondary nonferrous metals? Minority Populations and Low-Income D. Unfunded Mandates Reform Act C. How was GACT determined? Populations D. What are the proposed requirements for E. Executive Order 13132: Federalism area sources? F. Executive Order 13175: Consultation I. General Information VI. Proposed Exemption of Certain Area and Coordination with Indian Tribal A. Does this action apply to me? Source Categories from Title V Governments Permitting Requirements G. Executive Order 13045: Protection of The regulated categories and entities A. Clay Ceramics Manufacturing Children from Environmental Health and potentially affected by the proposed B. Secondary Nonferrous Metal Processing Safety Risks standards include:

Category NAICS Examples of regulated entities code 1

Industry: Clay Ceramics Manufacturing ...... 327122 Area source facilities that manufacture ceramic wall and floor tile, vitreous plumbing 327111 fixtures, vitreous china tableware and kitchenware, and/or pottery. 327112 Glass Manufacturing ...... 327211 Area source facilities that manufacture flat glass, glass containers, and other pressed 327212 and blown glass and glassware. 327213 Secondary Nonferrous Metals Proc- 331492 Area source brass and bronze ingot making, secondary magnesium processing, or essing. 331423 secondary zinc processing plant that melts post-consumer nonferrous metal scrap to make products including bars, ingots, and blocks, or metal powders.2 1 North American Industry Classification System. 2 The Secondary Nonferrous Metals Processing area source category was originally established under SIC code 3341, a broader classification which included brass and bronze ingot makers. The corresponding NAICS code for brass and bronze ingot makers is 331423.

This table is not intended to be Docket ID No. EPA–HQ–OAR–2006– the following address: http:// exhaustive, but rather provides a guide 0424 (for Clay Ceramics Manufacturing), www.epa.gov/ttn/oarpg/. The TTN for readers regarding entities likely to be or Docket ID EPA–HQ–OAR–2006–0360 provides information and technology affected by this action. To determine (for Glass Manufacturing), or Docket ID exchange in various areas of air whether your facility would be EPA–HQ–OAR–2006–0940 (for pollution control. regulated by this action, you should Secondary Nonferrous Metals D. When would a public hearing occur? examine the applicability criteria in 40 Processing). Clearly mark the part or all CFR 63.11435 of subpart RRRRRR of the information that you claim to be If anyone contacts EPA requesting to (national emissions standards for CBI. For CBI information in a disk or speak at a public hearing concerning the hazardous air pollutants (NESHAP) for CD–ROM that you mail to EPA, mark proposed rules by October 1, 2007, we Clay Ceramics Manufacturing Area the outside of the disk or CD–ROM as will hold a public hearing on October 5, Sources), 40 CFR 63.11448 of subpart CBI and then identify electronically 2007. If you are interested in attending SSSSSS (NESHAP for Glass within the disk or CD–ROM the specific the public hearing, contact Ms. Pamela Manufacturing Area Sources), and 40 information that is claimed as CBI. In Garrett at (919) 541–7966 to verify that CFR 63.11462 of subpart TTTTTT addition to one complete version of the a hearing will be held. (NESHAP for Secondary Nonferrous comment that includes information II. Background Information for Metals Processing). If you have any claimed as CBI, a copy of the comment Proposed Area Source Standards questions regarding the applicability of that does not contain the information this action to a particular entity, consult claimed as CBI must be submitted for A. What is the statutory authority for the either the air permit authority for the inclusion in the public docket. proposed NESHAP? entity or your EPA Regional Information so marked will not be Section 112(k)(3)(B) of the Clean Air representative as listed in 40 CFR 63.13 disclosed except in accordance with Act (CAA) requires EPA to identify at of subpart A (General Provisions). procedures set forth in 40 CFR part 2. least 30 hazardous air pollutants (HAP) which, as the result of emissions from B. What should I consider as I prepare C. Where can I get a copy of this 1 my comments to EPA? document? area sources, pose the greatest threat to public health in urban areas. Consistent Do not submit CBI to EPA through In addition to being available in the with this provision, in 1999, in the www.regulations.gov or e-mail. Send or docket, an electronic copy of this Integrated Urban Air Toxics Strategy, deliver information identified as CBI proposed action will also be available EPA identified the 30 HAP that pose the only to the following address: Roberto on the WorldWide Web (WWW) through greatest potential health threat in urban Morales, OAQPS Document Control the Technology Transfer Network Officer (C404–02), Office of Air Quality (TTN). Following signature, a copy of 1 An area source is a stationary source of HAP emissions that is not a major source. A major source Planning and Standards, Environmental the proposed action will be posted on is a stationary source that emits or has the potential Protection Agency, Research Triangle the TTN’s policy and guidance page for to emit 10 tons per year (tpy) or more of any HAP Park, North Carolina 27711, Attention newly proposed or promulgated rules at or 25 tpy or more of any combination of HAP.

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areas, and these HAP are referred to as www.epa.gov/ttn/atw/area/ Consistent with the legislative history, the ‘‘urban HAP.’’ See 64 FR 38706, arearules.html.) in addition to considering technical 38715–716, July 19, 1999. Section The inclusion of the Clay Ceramics capabilities of the facilities and the 112(c)(3) requires EPA to list sufficient Manufacturing, Glass Manufacturing, availability of control measures, we may categories or subcategories of area and Secondary Nonferrous Metals consider costs and economic impacts in sources to ensure that area sources Processing area source categories on the determining GACT, which is representing 90 percent of the emissions section 112(c)(3) area source category particularly important when developing of the 30 urban HAP are subject to list is based on 1990 emissions data, as regulations for source categories that regulation. EPA listed the source EPA used 1990 as the baseline year for may have few establishments and many categories that account for 90 percent of that listing. Specifically, the Clay small businesses. the urban HAP emissions in the Products Manufacturing area source Determining what constitutes GACT Integrated Urban Air Toxics Strategy.2 category was listed based on emissions involves considering the control Sierra Club sued EPA, alleging a failure of compounds of chromium, lead, technologies and management practices to complete standards for the source manganese, and nickel that represent that are generally available to the area categories listed pursuant to CAA part of the 90 percent of those urban sources in the source category. We also section 112(c)(3) and 112(k)(3)(B) within HAP emissions in the 1990 inventory consider the standards applicable to the timeframe specified by the statute. and are hereafter referred to as ‘‘clay major sources in the same industrial See Sierra Club v. Johnson, No. 01– ceramics metal HAP.’’ The Glass sector to determine if the control 1537, (D.D.C.). On March 31, 2006, the Manufacturing area source category was technologies and management practices court issued an order requiring EPA to listed based on emissions of compounds are transferable and generally available promulgate standards under CAA of arsenic, cadmium, chromium, lead, to area sources. In appropriate section 112(d) for those area source manganese, and nickel that represent circumstances, we may also consider categories listed pursuant to CAA part of the 90 percent of those urban technologies and practices at area and section 112(c)(3) and 112(k)(3)(B). HAP emissions in the 1990 inventory major sources in similar categories to Among other things, the order and are hereafter referred to as ‘‘glass determine whether such technologies requires that, by December 15, 2007, manufacturing metal HAP.’’ The and practices could be considered EPA complete standards for 10 area Secondary Nonferrous Metals generally available for the area source source categories. As part of our effort Processing area source category was category at issue. Finally, as noted to meet the December 15, 2007 deadline, listed based on emissions of compounds above, in determining GACT for a we are proposing in this action the of arsenic, chromium, lead, manganese, particular area source category, we NESHAP for the following three listed and nickel that represent part of the 90 consider the costs and economic area source categories: (1) Clay Ceramics percent of those urban HAP emissions impacts of available control Manufacturing; (2) Glass Manufacturing; in the 1990 inventory and are hereafter technologies and management practices and (3) Secondary Nonferrous Metals referred to as ‘‘secondary nonferrous on that category. Processing. The standards for the other metal HAP.’’ categories are being proposed in III. Proposed Area Source NESHAP for separate actions. B. What criteria did EPA use in Clay Ceramics Manufacturing developing the proposed NESHAP? We added Glass Manufacturing and A. What area source category is affected Secondary Nonferrous Metals Under CAA section 112(d)(5), the by the proposed rule? Processing to the Integrated Urban Air Administrator may, in lieu of standards The Clay Ceramics Manufacturing Toxics Strategy area source category list requiring maximum achievable control area source category includes those on June 26, 2002 (67 FR 43112). The technology (MACT) under section facilities that process greater than 45 Glass Manufacturing area source 112(d)(2), elect to promulgate standards megagrams per year (Mg/yr) (50 tons per category is comprised of three distinct or requirements for area sources ‘‘which year (tpy)) wet clay to manufacture industry sectors: (1) Flat Glass provide for the use of generally pressed floor tile, pressed wall tile, and Manufacturing; (2) Container Glass available control technologies or other pressed tile; sanitaryware (toilets Manufacturing; and (3) Pressed and management practices by such sources and sinks); dinnerware; or pottery. Clay Blown Glass Manufacturing. On to reduce emissions of hazardous air ceramics are primarily composed of clay November 22, 2002, we added Clay pollutants.’’ Under section 112(d)(5), the and shale, and may include many Products Manufacturing to the area Administrator has the discretion to use different additives, including silica, talc, source category list (67 FR 70428). The generally available control technology and various high purity powders Clay Products Manufacturing area or management practices (GACT) in lieu produced by chemical synthesis. source category was later split into the of MACT. Pursuant to section 112(d)(5), To estimate the number of facilities in two categories of Brick and Structural we have decided not to issue MACT the Clay Ceramics Manufacturing area Clay Products (BSCP) Manufacturing standards and concluded that GACT is source category, we gathered detailed and Clay Ceramics Manufacturing to appropriate for these three source information from the NESHAP for Clay better match the categories already categories. Ceramics Manufacturing major sources. scheduled to be regulated by major Additional information on the Also, we compiled information from source NESHAP. The Clay Ceramics definition of GACT is found in the other sources, including site visits, Manufacturing area source category is Senate report on the legislation (Senate Internet searches, and industry being addressed in this proposed rule, Report Number 101–228, December 20, submittals. Based on this information while the BSCP Manufacturing area 1989), which indicates GACT means: and taking into account recent facility source category will be addressed in a * * * methods, practices and techniques shutdowns, we have identified 51 area future action. (For more information on which are commercially available and source facilities with spray glaze the area source categories, see http:// appropriate for application by the sources in the category considering economic impacts operations or kilns that fire glazed 2 Since its publication in the Integrated Urban Air and the technical capabilities of the firms to ceramic ware that would be subject to Toxics Strategy in 1999, the area source category operate and maintain the emissions control the final clay ceramics manufacturing list has undergone several amendments. systems. area source NESHAP.

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With this action, we are also in terms of clay ceramics metal HAP designating the group of atomized spray clarifying that artisan potters, small emissions as a result of state and local glaze operations and kilns firing glazed ceramics studios, noncommercial air pollution standards, permit ceramic ware within the clay ceramics entities, and schools and universities requirements, and/or management manufacturing operation as the affected with ceramic arts programs, which practices already implemented by the source was the most appropriate typically have annual production rates industry to reduce clay ceramics metal approach and consistent with the basis of 45 Mg/yr (50 tpy) or less, are not a HAP from spray glaze operations. for the original listing. This proposed part of the source category listed Capture systems for spray glaze rule includes requirements for the pursuant to section 112(c)(3) and operations typically include spray control of emissions from all atomized (k)(3)(B), and are, therefore, not covered booths; partial or total enclosures; and spray glaze operations and all curing by this area source standard. Urban HAP process area ventilation systems. operations involving kilns firing glazed emissions from these facilities were not Several different types of air pollution ceramic ware. included in the 1990 baseline emissions control devices (APCD) are used to inventory that was used as the basis for control overspray emissions from glaze 2. Selection of Pollutants the area source category listing. spray booths, including wet scrubbers, For this proposed rule, we decided Specifically, in reviewing the inventory fabric filters, water curtains, and water- that it was not practical to establish on which we based the listing of this wash systems. individual standards for each specific source category, we determined that the Most, if not all, facilities practice type of clay ceramics metal HAP that sources that were the basis of the listing waste minimization in their glazing could be present in the various decision were those with an annual operations to minimize glaze cost and processes. A sufficient correlation exists production rate in excess of 45 Mg/yr cleanup downtime. Examples of waste between PM and these clay ceramics (50 tpy). minimization practices include, but are metal HAP to rely on PM as a surrogate not limited to, minimizing glaze for both the presence of the HAP and for B. What are the production processes overspray emissions using high-volume, their control.3 When released, each of and emissions points at facilities that low pressure (HVLP) spray equipment manufacture clay ceramics? the clay ceramics metal HAP or similar spray equipment; minimizing compounds behaves as PM. The control Clay ceramics manufacturing HAP emissions during cleanup of spray technologies used for the control of PM generally includes raw material glazing equipment; operating and emissions achieve comparable levels of processing and handling and forming of maintaining spray glazing equipment performance on the individual clay the clay product shapes, followed by according to manufacturer’s ceramics metal HAP emissions. drying, glazing, and firing. Some tile instructions; and minimizing spills Therefore, standards requiring good products and most dinnerware/pottery through careful handling of HAP- control of PM also achieve good control are fired in a kiln prior to some type of containing glaze materials. HVLP spray of clay ceramics metal HAP emissions. glazing operation. More than 95 percent equipment operates at low atomizing air Furthermore, establishing separate of all clay ceramic products are coated pressure—0.69 to 69 kilopascals (0.1 to standards for each individual metal with a glaze and then fired in a kiln. 10 pounds per square inch) at the air HAP would impose costly and Spray glaze operations and kilns that nozzle and use 0.42 to 0.85 cubic meters significantly more complex compliance fire glazed ceramic ware account for per minute (15 to 30 cubic feet per and monitoring requirements and most of the particulate matter (PM) and minute) of air. achieve little, if any, HAP emissions urban metal HAP emitted from clay No APCD are used by area sources in reductions beyond what would be ceramics manufacturing facilities (about the clay ceramics manufacturing achieved using the surrogate pollutant 80 to 90 percent from spray glaze industry to control emissions from approach based on total PM. Based on operations and 10 to 20 percent from kilns. However, available operating these considerations, we decided to kilns). Overspray accounts for most of permit information shows that most, if establish standards for Clay Ceramics the PM and clay ceramics metal HAP not all, clay ceramics kilns firing glazed Manufacturing based on control of total emitted during spray glaze operations. ceramic ware are fired with natural gas PM as a surrogate pollutant for the Emissions from kilns firing glazed or some other clean-burning, low-HAP individual clay ceramics metal HAP. ceramic ware consist primarily of fuel (e.g., propane). Some clay ceramics volatilized materials from the glaze. The manufacturing facilities use electric- C. How did EPA subcategorize spray type and volume of HAP emissions vary powered kilns. Furthermore, clay glaze operations? according to the glaze materials. ceramics manufacturing facilities As part of the GACT analysis, we Emissions of PM from spray glaze maintain the peak firing temperatures of considered whether there were operations and kilns firing glazed their kilns firing glazed ceramic ware differences in processes, sizes, or other ceramic ware are estimated at about 407 well below the volatilization factors affecting emissions that would Mg/yr (449 tpy) nationwide, with about temperatures of the clay ceramics metal warrant subcategorization. Under 7.1 Mg/yr (7.9 tpy) of clay ceramics HAP in their spray glazes. section 112(d)(1) of the CAA, EPA ‘‘may metal HAP (mostly lead and chromium, 1. Selection of Affected Source distinguish among classes, types, and with smaller quantities of nickel and sizes within a source category or Affected source means the collection manganese). Lead emissions are subcategory in establishing such of equipment and processes in the estimated at about 4.1 Mg/yr (4.5 tpy), standards* * *’’. In our review of the source category or subcategory to which and most of those emissions come from available data, we observed significant the subpart applies. In selecting the the two dinnerware facilities still using differences between spray glaze affected source for regulation, we leaded glazes. Since 1990, most clay operations based on the level of wet identified the clay ceramics metal HAP- ceramics facilities have ceased using glaze usage and clay ceramics metal emitting operations, the clay ceramics leaded glazes because of potential HAP emissions. For these reasons, we environmental and worker exposure metal HAP emitted, and the quantity of issues. clay ceramics metal HAP emissions 3 National Lime Association v. EPA. 233 F.3d 625, Spray glazing operations at area from the individual or groups of 639–640 (D.C. Cir. 2000) and Sierra Club v. EPA, source facilities are currently controlled emissions points. We concluded that 353 F.3d 976 (D.C. Cir. 2004).

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are proposing two subcategories for believe the consideration of costs and 2. GACT for Glaze Spray Booths at spray glaze operations based on annual economic impacts is especially Facilities with Wet Glaze Usage Above wet glaze usage: those facilities with important for the well-controlled clay 227 Mg/yr (250 tpy) annual wet glaze usage of more than 227 ceramics manufacturing area sources All of the known area source facilities Mg/yr (250 tpy) and facilities with because, given current well-controlled above the threshold of 227 Mg/yr (250 annual wet glaze usage of 227 Mg/yr levels, requiring additional controls tpy) with atomized spray glaze (250 tpy) or less. These subcategories would result in only marginal operations are controlled for PM differentiate between general sizes of reductions in emissions at very high emissions (e.g., water-wash system or glazing operations at clay ceramics costs for modest incremental wet scrubber). Many of the glaze spray manufacturing facilities, but do not improvement in control for this area systems and associated control differentiate clay product types or other source category. We explain below in equipment are custom-designed and processes. Those facilities with wet glaze usage detail our proposed GACT -built, depending on product type/size above the threshold level would be determinations. and glaze application spray rates. We lack empirical data for a majority of the subject to a different set of management 1. GACT for Kilns practices than those facilities at or facilities in this subcategory for below the threshold level, which are As noted previously, we are not aware performance testing or actual emission rates associated with spray glaze booths. more likely to be small businesses and of any APCD used by clay ceramics In evaluating GACT options, we comprise a much smaller fraction of manufacturing area source facilities to total production, glaze usage, and clay found that major source clay ceramics control emissions from kilns, but most, manufacturing facilities also utilize ceramics metal HAP emissions. Our if not all, clay ceramics kilns firing analysis indicates that approximately 88 similar PM controls on their spray glazed ceramic ware are fired with glazing operations. Based on the percent of wet glaze usage and 75 natural gas or some other clean-burning, percent of clay ceramics metal HAP existing operating permit requirements low-HAP fuel (e.g., propane). Based on for clay ceramics facilities, we found a emissions are associated with 11 clay the available information for all types ceramic manufacturing area source variety of formats and units, e.g., and sizes of kilns in this industry, we facilities in the subcategory with wet percent opacity, allowable PM or PM10 are not aware of any add-on control glaze usage levels greater than 227 Mg/ emission rates (pounds per hour (lbs/hr) yr (250 tpy) and the other 12 percent of techniques being used to reduce PM or tpy), percent removal efficiency, and wet glaze usage and 25 percent of clay emissions from kilns. Consequently, we outlet concentrations (grains per dry ceramics metal HAP emissions come determined GACT for kilns to be using standard cubic foot (gr/dscf)). While from 40 facilities in the subcategory natural gas, or an equivalent fuel, for all these requirements cover a wide range with wet glaze usage at or below 227 firing of glazed ceramic ware. For of spray glazing processes and products, Mg/yr (250 tpy). To account for those simplicity, we are proposing GACT for we believe that they achieve a similar facilities that use non-HAP glazes in all kilns that fire glazed ceramic ware at level of control and are generally some or all of their processes, we have a given facility and not differentiating available. (See technical memorandum included a provision allowing sources between the subcategories identified in in the docket for more details on spray to exclude glazes that contain less than the following sections of this preamble booth permit requirements and 0.1 (weight) percent clay ceramics metal involving glazing operations. There are estimated clay ceramics metal HAP HAP in determining their total wet glaze no differences in control equipment or emissions). Therefore, we determined usage relative to the 227 Mg/yr (250 tpy) control levels associated with kilns GACT for the subcategory for glaze subcategorization threshold. firing different amounts of glazed spray booths at facilities with wet glaze usage above 227 Mg/yr (250 tpy) to be ceramic ware; therefore, GACT is the D. How was GACT determined? an equipment requirement: wet control same for all kilns. As provided in CAA section 112(d)(5), systems for PM emissions. Per the we are proposing standards representing As noted previously, clay ceramics legislative history, a management GACT for the clay ceramics metal HAP. manufacturing facilities also maintain practice in the form of an equipment As noted in section II of this preamble, the peak firing temperatures of their requirement is an appropriate standard the statute allows the Agency to kilns firing glazed ceramic ware well under section 112(d)(5). establish standards for area sources below the volatilization temperatures of 3. GACT for Glaze Spray Booths at listed pursuant to section 112(c) based the clay ceramics metal HAP in their Facilities with Wet Glaze Usage At or on GACT. The statute does not set any spray glazes. For those clay ceramics Below 227 Mg/yr (250 tpy) condition precedent for issuing metal HAP that would be present in the standards under section 112(d)(5) other kiln exhaust, the lowest volatilization Area source facilities at or below the than that the area source category or temperature is approximately 1740°C threshold of 227 Mg/yr (250 tpy) subcategory at issue must be one that (3160°F) for lead. Based on available typically practice waste minimization in EPA listed pursuant to section 112(c), information, the highest peak firing their glazing operations to minimize which is the case here. temperature used in the clay ceramics glaze cost and cleanup downtime. We Moreover, most of the facilities in this evaluated the potential costs and manufacturing industry is source category have good operational emission reductions for APCD for approximately 1370°C (2500°F). In order controls in-place and use small facilities with lower glaze usage and to keep peak firing temperatures well quantities of clay ceramics metal HAP found the cost effectiveness to be in their glazes. We evaluated the control below the volatilization temperatures unreasonable, e.g., average cost of technologies and management practices for the relevant clay ceramics metal approximately $71,000/Mg ($64,000/ that reduce HAP emissions that are HAP, we are conservatively proposing ton) of PM and $10 million/Mg ($9 generally available for the clay ceramics GACT as requiring that facilities million/ton) of metal HAP. Therefore, manufacturing area source category. We maintain the peak firing temperatures of for the subcategory for glaze spray also considered costs and economic their kilns firing glazed ceramic ware booths at facilities with wet glaze usage impacts in determining GACT. We below 1540°C (2800°F). at or below 227 Mg/yr (250 tpy), we

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determined GACT for spray glaze For each atomized spray glaze operating conditions during monitoring; operations to be waste minimization operation located at a clay ceramics and the monitoring results). practices. manufacturing facility that uses 227 Mg/ Notification and recordkeeping yr (250 tpy) or less of wet glaze(s), the requirements. We are proposing that E. What are the proposed requirements proposed standards would require the affected sources submit Initial for area sources? facility owner or operator to employ Notifications and Notifications of 1. Applicability and Compliance Dates waste minimization practices in their Compliance Status under this proposed glazing operations. As an alternative to The proposed standards would apply rule because they are consistent with this proposed requirement, we are also to any new or existing affected source at the part 63 General Provisions and are providing the option to comply with the a clay ceramics manufacturing facility needed to identify the affected sources equipment standard or management that is an area source and uses more subject to the standards and confirm the practices for facilities with glaze usage than 45 Mg/yr (50 tpy) of clay. The compliance status of the sources. To greater than 227 Mg/yr (250 tpy) the affected source includes all kilns that ensure that facilities have sufficient threshold (i.e., PM controls or the use of fire glazed ceramic ware and all time to submit the notifications once the glazes containing less than 0.1 (weight) atomized spray glaze operations located rule was promulgated, we are proposing percent clay ceramics metal HAP), at such a facility. that facilities submit the notifications which is expected to provide emissions The owner or operator of an existing 120 days after the promulgation date. reductions equivalent or greater than affected source would have to comply (The promulgation date is also the those obtained using waste compliance date for this rule.) The with the standards by the date of minimization practices. promulgation of the final rule. The submittal date for the notifications is owner or operator of a new affected 3. Proposed Compliance Requirements based on the requirement for submitting Initial Notifications specified in the part source would be required to comply Initial compliance demonstration with the standards by the date of 63 General Provisions. requirements. The owner or operator We are soliciting information on any promulgation of the final rule, or upon would be required to include startup, whichever is later. control technologies or management compliance certifications for the practices used to limit emissions of PM 2. Proposed Standards proposed standards in their Notification or metal HAP from clay ceramics of Compliance Status. For any wet spray For each kiln firing glazed ceramic manufacturing area sources and any cost glaze operations controlled with an information associated with such ware, the proposed standards would APCD, an initial inspection of the require the facility owner or operator to control approaches. We also request control equipment must be conducted comment on GACT and the proposed maintain the kiln peak temperature within 60 days of the compliance date ° ° standards. below 1540 C (2800 F) and either use and the results of the inspection natural gas, or an equivalent clean- included in the Notification of IV. Proposed Area Source NESHAP for burning fuel, as the kiln fuel. The Compliance Status. Glass Manufacturing facility owner or operator would also Monitoring requirements. For each A. What area source category is affected have the option of using an electric- kiln firing glazed ceramic ware, the by the proposed rule? powered kiln. proposed standards would require the The requirements for atomized spray owner or operator to conduct a check of The glass manufacturing area source glaze operations at clay ceramic the kiln peak firing temperature on a category consists of plants that operate manufacturing area source facilities daily basis. If the peak firing one or more glass melting furnaces that differ depending on whether a facility temperature exceeds 1540 °C (2800 °F), produce at least 45 Mg/yr (50 tpy) of has annual wet glaze usage above or the owner or operator would be required glass and are charged with one or more below 227 Mg/yr (250 tpy). to take corrective action according to the of the glass manufacturing metal HAP. Consequently, we are proposing that the facility’s standard operating procedures. Pressed and Blown Glass and facility owner or operator maintain Based on available permit Glassware Manufacturing was listed as annual wet glaze usage records in order information, there are several clay an area source category on June 26, 2002 to document whether they are above or ceramic manufacturing area source (67 FR 43112). The inclusion of this below 227 Mg/yr (250 tpy) wet glaze facilities with weekly monitoring source category on the area source usage. requirements associated with APCD category list was based on emissions of For each atomized spray glaze used for PM emissions. For all sources the six glass manufacturing metal HAP. operation located at a clay ceramics that operate one or more APCD for their These HAP are emitted from glass manufacturing facility that uses more atomized spray glaze operations, we are melting furnaces. than 227 Mg/yr (250 tpy) of wet glaze(s), proposing daily and weekly visual The proposed glass manufacturing the proposed standards would require APCD inspections, daily EPA Method rule would apply to manufacturers the facility owner or operator to have an 22 visible emissions (VE) tests, or an producing glass by melting a mixture of APCD on their glazing operations and EPA-approved alternative monitoring minerals and other compounds, then operate and maintain the control device program to ensure that the APCD is kept cooling the melt in a manner that according to the equipment in a satisfactory state of maintenance prevents it from crystallizing. The manufacturer’s specifications. As a and repair and continues to operate primary constituent of all glass is silica, pollution prevention alternative to this effectively. but most glass contains several other proposed requirement, we are also The owner or operator would be minerals and substances. Examples providing the option to use glazes allowed to use existing operating permit include soda ash, potash, limestone, containing less than 0.1 (weight) percent documentation to meet the monitoring feldspar, potassium nitrate, boric acid, clay ceramics metal HAP for those requirements, provided it includes the iron oxide, and sodium nitrate. Metal facilities above the threshold, which is necessary monitoring records (e.g., the oxides can be included in the glass expected to provide emissions date, place, and time of the monitoring; manufacturing formulation to produce reductions equivalent or greater than the person conducting the monitoring; colored or tinted glass. Some examples those obtained using PM controls. the monitoring technique or method; the include iron oxide, chromium oxide,

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cobalt oxide, nickel, and selenium. obtain reductions of the glass per year reductions in glass Other compounds, such as lead oxide manufacturing metal HAP also reduce manufacturing metal HAP and 415 tons and arsenic compounds, can be added emissions of other metal HAP where per year reductions in PM. We explain to enhance or modify the final product. they are used in the same process. below in detail our proposed GACT Recycled glass, also known as cullet, is determinations. 1. Selection of Source Category a primary ingredient of many glass 1. Background formulations. Although listed originally as ‘‘Pressed Glass manufacturing plants can be and Blown Glass and Glassware Section 112(d)(5) of the CAA allows broadly classified by product type as Manufacturing,’’ the Glass us to develop area source standards one of the following: Flat glass, Manufacturing area source category based on GACT. In identifying GACT for container glass, or pressed and blown listing was based upon data from all of the affected sources in the Glass glass. Flat glass includes plate glass the three primary sectors of the glass Manufacturing area source category, we used for building windows and manufacturing industry: Flat glass, compiled data on existing glass automobile windshields. Container glass container glass, and pressed and blown manufacturing plants through a series of includes soda, beer, and wine bottles, glass. We are clarifying that the Glass site visits, a Section 114 information jars, and other glass containers. Pressed Manufacturing area source category collection request (ICR), operating and blown glass includes a wide variety includes any glass manufacturing permits and permit applications, of products such as light bulbs, glass facility that operates one or more emission inventory reports, emission tubing, optical glass, glass cooking ware, furnaces which produce at least 45 Mg/ test reports, published reports on the and industrial glassware. yr (50 tpy) of glass per furnace and use industry, and databases such as the As noted previously, the glass the glass manufacturing metal HAP Toxic Release Inventory and National manufacturing area source category was compounds as raw materials, regardless Emission Inventory (NEI) databases. listed based on emissions of the six of the type of glass product Detailed data on approximately 80 glass glass manufacturing metal HAP. The manufactured. This clarification does manufacturing plants were compiled in Section 112(k) inventory included not change the universe of sources that a database, which we then used for emissions of these metal HAP from glass were the basis of the original listing subsequent analyses to determine manufacturing plants that use notice. GACT. compounds of one or more of the metal The data compiled on existing glass 2. Selection of Affected Sources HAP as raw materials that are added to manufacturing facilities included permit the glass manufacturing formulation to The affected source includes glass limits for PM emissions for impart specific characteristics to the manufacturing furnaces that meet two approximately 150 furnaces. When final glass product. We estimate that criteria: The furnaces are charged with converted to a common format (e.g., there currently are 21 such plants in one or more of the glass manufacturing pounds per ton (lbs/ton)) the data show operation in the U.S., and these 21 metal HAP as raw materials, and the a wide range in PM emission limits. To plants comprise the glass manufacturing furnaces have annual production rates meet the most stringent PM emission area source category. of at least 45 Mg/yr (50 tpy). We limits specified in title V permits, plants selected furnaces as the affected source typically use electrostatic precipitators B. What are the production processes because glass melting furnaces emit the (ESPs) or fabric filters. and emission points at facilities that HAP for which this source category was The data also show that many existing manufacture glass? listed pursuant to sections 112(c)(3) and glass furnaces are subject to 40 CFR 60, Regardless of the type of glass, the (k)(3)(B) (i.e., arsenic, cadmium, subpart CC, Standards of Performance process of manufacturing glass entails chromium, lead, manganese, and for Glass Manufacturing Plants (Glass batch measuring and mixing raw nickel). NSPS). The Glass NSPS establishes materials in specified proportions, emission limits for PM and applies to all C. How was GACT determined? charging the raw material batch mix into glass manufacturing plants constructed a furnace, where it is melted to form While most of the facilities that would or modified since 1980 that produce or molten glass, forming the molten glass be subject to the proposed rule have have the design capacity to produce at into the desired shapes, and finishing good operational controls in place to least 4,550 kilograms (kg) (about 5 tons) and packaging the final product. control emissions of glass of glass in one day. Depending on the Compounds of the glass manufacturing metal HAP, a few glass recipe, fuel, and process used, the manufacturing metal HAP are facilities would have to install emission NSPS limits range from 0.2 to 2.0 lbs of incorporated into glass manufacturing controls or change their glass PM/ton of glass produced. To comply batch formulations to either color, tint, formulation to meet the emission limits with the NSPS, plants typically use ESP, or impart certain characteristics, such as in the proposed rule. We considered fabric filters, or process modifications. clarity and brilliance, to the final glass costs and economic impacts in Based on the data compiled, product. Lead oxide is used as a determining GACT and found that the approximately 40 percent of container clarifier, former, stabilizer, and for cost effectiveness of reducing PM–10 glass furnaces, 50 percent of flat glass radiation shielding in glass. Arsenic is using add-on control is excellent for PM furnaces, and 25 percent of pressed and used as a fining agent to facilitate the as well as for reducing glass blown glass furnaces are subject to the removal of bubbles from molten glass. manufacturing metal HAP. While we NSPS. The other four glass manufacturing believe the consideration of costs and metal HAP compounds are used economic impacts is important for area 2. Selection of PM as a Surrogate for primarily to color or tint the glass. sources, we found that the emission Glass Manufacturing Metal HAP Other metal HAP may also be emitted reductions achieved by the proposed For glass manufacturing furnaces that from glass manufacturing furnaces. rule were compelling. Our analyses are charged with any of the glass These include antimony, selenium, and show that the proposed rule would manufacturing metal HAP as raw cobalt. Although the source category result in substantial reductions in materials, PM emissions contain those was not listed for these other metal emissions at reasonable costs for this glass manufacturing metal HAP, and HAP, the air pollution controls used to area source category, achieving 28 tons emissions control equipment that is

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designed and operated to control PM container glass sectors that are charged use a glass manufacturing formulation emissions also control emissions of the with metal HAP. For furnaces in the that retains most of the metal HAP in glass manufacturing metal HAP. pressed and blown glass sector that the glass product. In both cases, the cost Furthermore, many glass manufacturing produce glass using metal HAP, effectiveness for installing controls to plants have title V operating permits approximately 38 percent are controlled meet the proposed 0.2 lb/ton PM that require PM emissions controls and with ESPs and 24 percent are controlled emission limit could exceed several establish emissions limits for PM. For with fabric filters. million dollars per ton of metal HAP these reasons, we are proposing to The available test data on controlled removed. In such cases, the equivalent establish standards using PM as a emissions of PM and/or metal HAP from metal HAP emission limit of 0.02 lb/ton surrogate for the glass manufacturing furnaces were reviewed. The resulting would allow plants to comply with the metal HAP. Controlling PM emissions data set includes the results from 19 proposed rule by using glass will control emissions of the glass tests of PM emissions on ESP-controlled formulations with very low metal HAP manufacturing metal HAP since the furnaces. The emission factors emissions. metals are contained within the PM— developed from the data ranged from Our GACT determinations reflect the they are in the particulate form as 0.032 to 0.25 lb PM/ton of glass levels of emissions reductions that are opposed to the gaseous form. Particulate produced, and the average emission being achieved by well-controlled matter controls used at existing glass factor was determined to be 0.11 lb PM/ sources, and we have concluded that the manufacturing plants are the same ton of glass produced. In order to proposed rule would achieve significant controls available to control particulate establish an emission limit representing reductions of metal HAP and PM when metal HAP such as the six glass the variation in normal process applied to this source category. We manufacturing metal HAP. These operation and emissions from a well- considered the costs and economic controls capture particulate metal HAP controlled glass furnace, we utilized a impacts of the proposed emission limits. non-preferentially along with other PM, statistical approach by calculating the We also considered whether an thus making PM a reasonable surrogate 99th percentile of the data set. This emission limit more stringent than the for the metal HAP. We have used this resulted in a PM emission limit of 0.2 0.2 lb PM/ton or 0.02 lb metal HAP/ton approach in several other NESHAP in lb/ton. could be achieved by facilities using the which PM was determined to be a As an alternative to expressing the technologies described above. We are surrogate for the metal HAP in the PM. identified limit in terms of PM, we proposing that requiring more stringent evaluated expressing the limit in terms 3. Selection of Emission Factor Format emission limits would not result in of an equivalent emission limit for metal significantly greater emission reductions The data compiled on existing glass HAP. In this regard, we reviewed the than what we project the proposed rule manufacturing facilities included permit available data on controlled furnaces would achieve. Requiring additional limits for PM emissions for that were charged with the glass controls would result in only marginal approximately 150 furnaces. The permit manufacturing metal HAP as raw reductions of emissions at very high limits are expressed in a variety of materials. The resulting data set costs for modest incremental formats (units), such as emission factors included the results from 15 emission improvement in control for this area or production-based mass emission rates tests. The emission factors developed source category. (e.g., lbs emitted per ton of glass from the data ranged from 0.0001 to produced), emission concentrations 0.023 lb metal HAP/ton and averaged D. What are the proposed requirements (e.g., gr/dscf of exhaust), and emission 0.008 lb metal HAP/ton. Applying the for area sources? rates (e.g., lbs/hr). Due to the wide range same methodology that we used to 1. Applicability and Compliance Dates in furnace sizes, we are proposing to use determine the PM emission limit for the emission factor format because this GACT, we developed GACT in terms of The proposed NESHAP would apply format normalizes emissions as a an equivalent metal HAP emission limit to any glass manufacturing plant that is function of production rate. to be 0.02 lb metal HAP/ton of glass an area source of HAP emissions and Furthermore, of the 150 permit limits produced. We consider the PM emission operates one or more furnaces which reviewed, the permits for 55 furnaces factor of 0.2 lb/ton of glass produced produce at least 50 tpy of glass per specified emission limits in the format and the glass manufacturing metal HAP furnace by melting a mixture of raw of an emission factor. In addition, the emission factor of 0.02 lb/ton of glass materials that includes compounds of Glass NSPS specifies emission limits as produced to be equivalent measures of one or more of the glass manufacturing emission factors. GACT for well-controlled glass metal HAP. manufacturing furnaces. Under this proposed rule, the 4. Selection of GACT for Glass Melting The estimated cost effectiveness for compliance date for existing sources Furnaces requiring furnaces charged with glass would be 2 years following In evaluating GACT for the glass manufacturing metal HAP to meet the promulgation of the final rule. However, manufacturing area source category, we 0.2 lb/ton PM emission limit ranges owners or operators of affected sources reviewed the available data for glass from approximately $2,000 to $6,300 could request an extension of an melting furnaces that have installed per ton of PM removed. In terms of additional one year to comply with the emission controls to reduce emissions of metal HAP removed, the cost proposed rule, as allowed under section PM and metal HAP. Electrostatic effectiveness of meeting the 0.2 lb/ton 112(i)(3)(B) of the CAA and under precipitators are by far the most PM emission limit depends largely on § 63.6(i)(4)(A), if the additional time is commonly used device for controlling the amount of metal HAP included in needed to install emission controls. The emissions of PM or metal HAP from the batch formulation. For example, for request for an extension of the glass furnaces. Among the furnaces that furnaces that produce glass containing compliance date would have to be produce glass using metal HAP 30 percent lead, the cost effectiveness submitted to the permitting agency no compounds as raw materials, would be approximately $6,500 per ton later than 12 months prior to the approximately 35 percent are controlled of metal HAP removed. However, some compliance date. In addition, the owner with ESPs. This includes all of the facilities produce glass using metal HAP or operator would have to apply for a controlled furnaces in the flat glass and in very small amounts; some plants also revision of the facility’s title V permit to

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incorporate the conditions of the continuous parameter monitoring proposed rule would require annual compliance date extension. The systems to continuously measure and inspections of the ductwork, hopper, compliance date for new or record the secondary voltage and and housing, and inspections of the ESP reconstructed sources would be the date electrical current to each field of the interior every 2 years. of promulgation of the final rule or the ESP. We selected these parameter 6. Notification and Recordkeeping startup date for the source, whichever is monitoring requirements because later. The compliance date for facilities secondary voltage and secondary Requirements with no affected sources at the time of electrical current are reliable indicators Under this proposal, owners and promulgation and which later change of ESP performance. Either of these operators of all affected glass processes or increase production and parameters dropping below established manufacturing plants that operate at trigger applicability of the proposed levels provides an indication that the least one furnace that produces at least rule, would be 2 years following the electrical power to the ESP field in 45 Mg/yr (50 tpy) of glass using any of date on which the facility made the question has decreased and collection the glass manufacturing metal HAP as process changes or increased production efficiency may have decreased raw materials would be required to and thereby became subject to the accordingly. submit an Initial Notification, as proposed NESHAP. The proposed rule would require required under § 63.9(b). Any facility owners or operators of an existing with an affected source would also have 2. Proposed Standards for New, affected glass furnace that is controlled to submit a Notification of Compliance Existing, and Reconstructed Sources with a fabric filter to monitor the fabric Status, as specified in § 63.9(h). This proposed rule would require filter inlet temperature continuously Owners and operators of glass new and existing affected furnace to and record the results at least once manufacturing facilities would be comply with a PM emission limit of 0.2 every 8 hours. We selected this required to keep records of all lb/ton of glass produced or an monitoring requirement because it is notifications, as well as supporting equivalent metal HAP emission limit of important to ensure that the exhaust gas documentation for the notifications. In 0.02 lb/ton of glass produced. We temperature does not exceed the addition, they would be required to selected these emission limits based on maximum allowable temperature for the keep records of performance tests; GACT for glass manufacturing furnaces, filter bags. This proposed rule would parameter monitoring data; monitoring as explained in Section IV.C. of this require the owner or operator of a new system audits and evaluations; preamble. or reconstructed affected furnace that is operation and maintenance of control equipped with a fabric filter to install 3. Initial Testing Requirements devices and monitoring systems; control and operate a bag leak detector. Bag leak device inspections; and glass The proposed rule would require an detectors provide a reliable and cost- manufacturing batch formulation and initial one-time performance test on effective indicator of tears and other production. each affected furnace unless the furnace damage to fabric filter bags. We selected the requirement for had been tested during the previous 5 As an alternative to monitoring ESP submitting Initial Notifications and years, and the previous test secondary voltage and electrical current Notifications of Compliance Status demonstrated compliance with the or fabric filter inlet temperature, owners under this proposed rule because these emission limits in this proposed rule or operators of affected furnaces requirements are specified in the part 63 using the same test methods and equipped with either of these control General Provisions (subpart A). The procedures specified in this proposed devices would have the option of specific recordkeeping requirements rule. The initial performance test is requesting alternative monitoring, as were selected because they are needed to demonstrate that affected allowed under § 63.8(f). The alternative consistent with the part 63 General sources meet the emission limits. monitoring request would have to Provisions and are needed to document To demonstrate compliance with the include a description of the monitoring compliance with the requirements of PM emission limits, the proposed rule device or monitoring method that would this proposed rule. would require testing using Methods 5 be used; instrument location; inspection or 17. Method 5 is a standard method procedures; quality assurance and V. Proposed Area Source NESHAP for for measuring PM and is the test method quality control measures; the parameters Secondary Nonferrous Metals specified in the Glass NSPS. Method 17 that would be monitored; and the Processing is a standard alternative method for PM frequency with which the operating A. What area source category is affected where in-stack testing is appropriate. To parameter values would be measured by the proposed rule? meet the metal HAP emission limit, and recorded. The owner or operator of plants would be required to test using an affected furnace that is equipped Secondary nonferrous metals Method 29, which is the standard with a control device other than an ESP processing facilities are facilities that method for measuring any metal HAP. or fabric filter, or that uses other use furnaces to melt post-consumer methods to reduce emissions, would be nonferrous metal scrap to make 4. Monitoring Requirements required to submit a request for products including bars, ingots, blocks, Under the proposed rule, the owner or alternative monitoring, as described in and metal powders. The Secondary operator of an existing affected glass § 63.8(f). Nonferrous Metals Processing area furnace that is controlled with an ESP source category consists of brass and would be required to monitor the 5. Control Device Inspections bronze ingot makers, secondary secondary voltage and secondary Under this proposed rule, the owner magnesium processors, and secondary electrical current to each field of the or operator of an affected furnace would zinc processors. This area source ESP continuously and record the results be required to conduct initial and category was listed pursuant to the at least once every 8 hours. This periodic inspections of the furnace Urban Air Toxics Strategy (67 FR 43112, proposed rule would require the owner control device. For fabric filters, the June 26, 2002) due to the emissions of or operator of a new or reconstructed proposed rule would require annual the urban HAP arsenic, chromium, lead, affected furnace equipped with an ESP inspections of the ductwork, housing, manganese, and nickel, all of which are to install and operate one or more and fabric filter interior. For ESP, the metal HAP.

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In May 2006, we sent an ICR to 98 processor is currently in operation in at all secondary nonferrous metal secondary nonferrous metal processing the U.S. and that facility is equipped processing facilities. facilities identified by TRI, NEI and with a baghouse on the furnace exhaust. 2. Selection of Pollutants Internet searches, as well as contact Secondary zinc processors also emit with trade associations. Of the 98 PM that may contain lead during For this proposed rule, we decided facilities receiving the ICR, the ICR was crushing and screening operations and that it was impractical to establish determined to be applicable to 10 melting operations. Furnaces used in individual standards for each specific facilities. Therefore there are 10 secondary zinc processing include secondary nonferrous metal HAP that facilities in this area source category. natural gas-fired kettle, crucible, and could be present in the various These facilities include brass and retort furnaces and electric induction processes (e.g., separate standards bronze ingot makers, secondary furnaces. arsenic, chromium, lead, manganese, magnesium processors, and secondary Furnace distillation with oxidation and nickel). Establishing separate zinc processors. Reasons for why the produces zinc oxide dust. Distillation standards for each individual metal ICR was not applicable to many involves vaporization of zinc at HAP would impose costly and facilities that received the initial ICR temperatures from 982 to 1249 °C (1800 significantly more complex compliance mailing included: (1) The facilities were to 2280 °F). The zinc vapor discharges and monitoring requirements. All of the urban HAP emitted by no longer operating, (2) the facilities directly into an air stream leading to a sources in this area source category are were included in another secondary refractory-lined combustion chamber. nonferrous category such as secondary metal HAP. When released, each of Excess air completes the oxidation and these secondary nonferrous metal HAP lead, secondary aluminum, or secondary cools the zinc oxide dust which is then copper, (3) the facilities reported no compounds behaves as PM. collected in a fabric filter as the final Accordingly, standards requiring good emissions of the urban HAP arsenic, product. Because the zinc oxide dust is chromium, lead, manganese, or nickel, control of PM (e.g., requiring a the product, well-performing fabric baghouse) will also effectively control (4) the facilities processed ferrous filters are used to optimize product material, or (5) the facilities performed the secondary nonferrous metal HAP recovery. emissions from sources in this area no urban HAP-emitting processing According to the information we operations (e.g., scrap wholesalers). source category. Based on these received, emissions from furnace considerations, we are proposing B. What are the production processes operations at the secondary nonferrous standards for Secondary Nonferrous and emissions points at facilities that metals processing facilities and Metals Processing based on control of process secondary nonferrous metals? secondary zinc crushing and screening total PM as a surrogate pollutant for the Basic production processes at operations are all currently controlled individual secondary nonferrous metal secondary nonferrous metals processing by fabric filters or baghouses, and the HAP. facilities are: (1) Material handling and collection efficiency of these fabric A sufficient correlation exists between pretreatment, which may include filters or baghouses during normal PM and these secondary nonferrous crushing and screening operations, (2) operations all exceed 99 percent. metal HAP to rely on PM as a surrogate metal charging and melting, (3) metal 1. Selection of Affected Source for both the presence of the HAP and for pouring and cooling, (4) removal of their control. When released, each of the cooled metal from molds, and (5) Affected source means the collection secondary nonferrous metal HAP finishing. of equipment and processes in the compounds behaves as PM. The control Brass and bronze ingot makers source category or subcategory to which technologies used for the control of PM include facilities where secondary the subpart applies. The affected source emissions achieve comparable levels of copper scrap (e.g., number 1 copper may be the same collection of performance on the individual scrap) is used to supplement copper equipment and processes as the source secondary nonferrous metal HAP. alloy scrap that is remelted and poured category or it may be a subset of the Further, as previously mentioned, the into ingots. Furnaces used in secondary source category. For each rule, we must amount of secondary nonferrous metal brass and bronze ingot making include decide which individual pieces of HAP emissions from brass and bronze natural gas-fired rotary kilns and equipment and processes warrant ingot making, secondary magnesium electric induction furnaces. standards in the context of the CAA processing, and secondary zinc Furnaces used in brass and bronze section 112 requirements and the processing can vary depending on the ingot making emit PM containing industry operating practices. HAP content in the incoming scrap metals. The PM emissions are totally We are proposing to designate as the metals. Because of the inherent dependent upon the incoming scrap affected source in this proposed area variability and unpredictability of the metal which may contain the following source NESHAP all secondary HAP compositions and amounts in urban HAP: lead and smaller amounts of nonferrous metal HAP-emitting incoming scrap material, it is difficult to cadmium, nickel, and manganese. In operations at brass and ingot making, establish individual numerical some brass and bronze ingot making secondary magnesium processing, and emissions for each secondary processes, exhaust gases are drawn secondary zinc processing facilities. nonferrous metal HAP. through a quench chamber to cool the Specifically, based on data from ICR gases prior to entering the baghouses to responses, we are designating as the C. How was GACT determined? prevent the gases from damaging or affected source all crushing or screening All of the facilities in this source destroying the bag filters. operations at secondary zinc processing category have good operational controls Furnaces in secondary magnesium facilities and furnace melting operations in-place and most incoming materials processing emit PM which may contain at all secondary nonferrous metal contain small quantities of secondary the urban HAP manganese. Furnaces processing facilities. This proposed rule nonferrous metal HAP. We evaluated used in secondary magnesium includes requirements for the control of the control technologies and processing include natural gas-fired emissions from all crushing or screening management practices that reduce HAP crucibles and electric induction operations at secondary zinc processing emissions that are generally available furnaces. One secondary magnesium facilities and furnace melting operations for the secondary nonferrous metals

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processing area source category. We also baghouse or fabric filter that achieves a any existing or new affected source considered costs and economic impacts PM control efficiency of at least 99.5 would be required to include initial in determining GACT. We believe the percent as GACT for new affected compliance certifications for the consideration of costs and economic sources. proposed standard in their Notification impacts is especially important for the of Compliance Status. D. What are the proposed requirements well-controlled secondary nonferrous The owner or operator of each for area sources? metals processing area sources because, existing and new affected source would given current well-controlled levels, 1. Applicability and Compliance Dates be required to conduct an initial requiring an additional level of control The proposed standards would apply inspection of each baghouse. The owner would result in only marginal to any new or existing affected source at or operator would be required to reductions in emissions at very high an area source secondary nonferrous visually inspect the system ductwork costs for modest incremental metals processing facility. The affected and baghouse unit for leaks and inspect improvement in control for this area source includes all crushing or the inside of each baghouse for source category. We explain below in screening operations at a secondary zinc structural integrity and fabric filter detail our proposed GACT processing facility and all furnace condition. The owner or operator would determinations. melting operations located at a be required to record the results of the inspection and any maintenance action 1. GACT for Existing Sources secondary nonferrous metals processing facility. taken. In identifying GACT for existing The owner or operator of an existing For each installed baghouse which affected sources in the Secondary affected source would have to comply has been operated within 60 days of the Nonferrous Metals Processing area with the standards by the date of compliance date, the owner or operator source category, we considered the promulgation of the final rule. The would be required to conduct the initial available data on the 10 existing owner or operator of a new affected inspection no later than 60 days after facilities. In their ICR responses, these source would be required to comply the applicable compliance date. For an facilities reported using baghouses on with the standards by the date of installed baghouse which has not been crushing or screening operations at promulgation of the final rule, or upon operated within 60 days of the secondary zinc facilities and on furnace initial startup, whichever is later. compliance date, the owner or operator melting operations at all facilities and would be required to conduct an initial that such baghouses performed at a PM 2. Proposed Standards inspection prior to startup of the collection efficiency of at least 99 The proposed standards would baghouse. percent or achieved an outlet require the owner or operator of an An initial inspection of the internal concentration of at least 0.050 grams per existing affected source to route the components of a baghouse is not dry standard cubic meter (0.022 gr/dscf) emissions from the affected source required if an inspection has been where collection efficiency was not through a fabric filter or baghouse that performed within the past 12 months. reported. achieves a control efficiency of at least Monitoring requirements. For existing We are proposing using a baghouse or 99.0 percent. affected sources, the owner or operator fabric filter that achieves a PM control The proposed standards would would be required to conduct either efficiency of at least 99 percent as GACT require the owner or operator of a new daily EPA Method 22 VE tests or weekly for existing sources because we affected source to route the emissions visual inspections of the baghouse determined that this level of control is from the affected source through a fabric system ductwork for leaks, as well as generally available, is cost effective, and filter or baghouse that achieves a control yearly inspections of the interior of the is effective for controlling emissions of efficiency of at least 99.5 percent. baghouse to determine its structural PM and secondary nonferrous metal integrity and to determine the condition 3. Proposed Compliance Requirements HAP. of the fabric filter. These monitoring Performance test requirements. The requirements would ensure that the 2. GACT for New Sources owner or operator of any existing or new baghouse is kept in a satisfactory state In identifying GACT for new affected affected source would be required to of maintenance and repair and sources in the Secondary Nonferrous conduct a one-time initial performance continues to operate efficiently. Metals Processing area source category, test on the affected source. Existing For new affected sources, the owner we considered the available data on the affected sources that were tested within or operator would be required to operate 10 existing facilities. The best the past 5 years of the compliance date and maintain a bag leak detection performing facilities reported that each would be exempt from this one-time test system for each baghouse used to baghouse used at their facilities if the test were conducted using the comply with the proposed standards. performed at a PM collection efficiency same procedures specified in the We decided to require bag leak of at least 99.5 percent. proposed standards and either no detection systems because these systems We contacted baghouse manufacturers process changes had been made since can be incorporated into the design and to gather information on design the test, or the owner or operator must operation of new sources without parameters and performance for new demonstrate that the results of the retrofitting, as would be the case if they baghouse installations in the secondary performance test, with or without were to be incorporate into existing nonferrous metals processing industry. adjustments, reliably demonstrated sources. Bag leak detection systems are Furthermore, we also considered the compliance despite process changes. typical requirements in our regulations performance of baghouses at similar Existing and new affected sources of new sources that are of the size and sources (e.g., melting furnaces used in would have to be tested using Methods complexity as secondary nonferrous other industries). 5 or 17. Method 5 is a standard method metals processing facilities. Based on available data on the 10 for measuring PM and Method 17 is a The proposed standards would existing facilities, contact with baghouse standard alternative method for PM require the owner or operator to keep manufacturers, and consideration of where in-stack testing is appropriate. records of the date, place, and time of baghouse performance at similar Initial compliance demonstration the monitoring; the person conducting sources, we are proposing using a requirements. The owner or operator of the monitoring; the monitoring

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technique or method; the operating burdensome’’ on a particular area source sections VI.A and VI.B of this preamble, conditions during monitoring; and the category include: (1) Whether title V we have determined that the proposed monitoring results. would result in significant exemptions from title V would not Notification and recordkeeping improvements to the compliance adversely affect public health, welfare requirements. We are proposing that requirements, including monitoring, and the environment. affected sources submit Initial recordkeeping, and reporting, that are A. Clay Ceramics Manufacturing Notifications and Notifications of proposed for an area source category (70 Compliance Status because they are FR 75323); (2) whether title V We compared the title V monitoring, needed to identify the affected sources permitting would impose significant recordkeeping, and reporting subject to the proposed standards and to burdens on the area source category and requirements (factor one) to the confirm the compliance status of the whether the burdens would be requirements in the proposed NESHAP sources. To ensure that facilities have aggravated by any difficulty the sources for the Clay Ceramics Manufacturing sufficient time to submit the may have in obtaining assistance from area source category. EPA determined notifications once the rule is permitting agencies (70 FR 75324); (3) that the management practices currently promulgated, we are proposing that whether the costs of title V permitting used at most facilities is GACT, and the facilities submit the notifications no for the area source category would be proposed rule requires recordkeeping later than 120 days after the compliance justified, taking into consideration any that serves as monitoring and deviation date for this rule. The submittal date for potential gains in compliance likely to reporting to assure compliance with the the notifications is based on the occur for such sources (70 FR 75325); NESHAP. The monitoring component of requirement for submitting Initial and (4) whether there are the first factor favors title V exemption Notifications specified in the part 63 implementation and enforcement because this proposed standard General Provisions. programs in place that are sufficient to provides monitoring that assures We are soliciting information on any assure compliance with the NESHAP for compliance with the requirements of the control technologies or management the area source category, without relying proposed rule. For atomized glaze spray practices used to limit emissions of PM on title V permits (70 FR 75326). operations, the proposed NESHAP or metal HAP from secondary In discussing the above factors in the requires the use of PM control systems nonferrous metals processing area Exemption Rule, we explained that we (e.g., water-wash system or wet sources and any cost information considered on ‘‘a case-by-case basis the scrubber) or management practices (e.g., associated with such control extent to which one or more of the four HVLP spray equipment); and periodic approaches. We also request comment factors supported title V exemptions for visual APCD inspections at existing on GACT and the proposed standards. a given source category, and then we sources; daily VE tests; or an EPA- approved alternate monitoring program. VI. Proposed Exemption of Certain assessed whether considered together For kilns that fire glazed ceramic ware, Area Source Categories From Title V those factors demonstrated that the proposed NESHAP requires Permitting Requirements compliance with title V requirements would be ‘unnecessarily burdensome’ management practices (i.e., kiln fuel and We are proposing exemptions from on the category, consistent with section firing temperature) and a daily peak title V permitting requirements for 502(a) of the Act.’’ See 70 FR 75323. firing temperature check. For those affected facilities in the clay ceramics Thus, in the Exemption Rule, we compliance options involving and secondary nonferrous metals explained that not all of the four factors management practices, monitoring other processing area source categories for the must weigh in favor of exemption for than recordkeeping is not practical or reasons described below. Glass EPA to determine that title V is appropriate. Records are required to manufacturers that would be subject to unnecessarily burdensome for a assure that the management practices this proposed rule are already subject to particular area source category. Instead, are followed, including records of the title V requirements because they are the factors are to be considered in type of air pollution control used, the major sources of PM, NOX, or both. combination, and EPA determines types and quantities of wet glazes used, Therefore, we are not proposing to whether the factors, taken together, the type of fuel used in the kilns, and exempt the glass manufacturing area support an exemption from title V for a the kiln peak firing temperature. source category from title V. particular source category. As part of the first factor, we have Section 502(a) of the CAA provides We examined the four factors for both considered the extent to which title V that the Administrator may exempt an of the area source categories that we are could potentially enhance compliance area source category from title V if he proposing an exemption. As explained for area sources covered by this determines that compliance with title V below, after evaluating the relevant proposed rule through recordkeeping or requirements is ‘‘impracticable, factors, we concluded that the reporting requirements. We have infeasible, or unnecessarily requirements of title V would be considered the various title V burdensome’’ on an area source unnecessarily burdensome on the area recordkeeping and reporting category. See CAA section 502(a). In source categories for which we are requirements, including requirements December 2005, in a national proposing an exemption from title V. for a 6-month monitoring report, rulemaking, EPA interpreted the term In the Exemption Rule, in addition to deviation reports, and an annual ‘‘unnecessarily burdensome’’ in CAA determining whether compliance with certification in 40 CFR 70.6 and 71.6. section 502 and developed a four-factor title V requirements would be For any affected clay ceramics balancing test for determining whether unnecessarily burdensome on an area manufacturing area source facility, the title V is unnecessarily burdensome for source category, we considered, proposed NESHAP requires an initial a particular area source category, such consistent with the guidance provided notification and a notification of that an exemption from title V is by the legislative history of section compliance status. The proposed clay appropriate. See 70 FR 75320, December 502(a), whether exempting the area ceramics manufacturing NESHAP also 19, 2005 (‘‘Exemption Rule’’). source category would adversely affect requires affected facilities to maintain The four factors that EPA identified in public health, welfare or the records showing compliance with the the Exemption Rule for determining environment. See 70 FR 15254–15255, required equipment standard and whether title V is ‘‘unnecessarily March 25, 2005. As discussed below in management practices. The information

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required in the notifications and records information on the overall burdens and title V exemptions for clay ceramics is similar to the information that must costs, as well as the relative burdens of manufacturing area sources. be provided in the deviation reports each activity described here. Also, for a The fourth factor we considered in required under 40 CFR 70.6(a)(3) and 40 more comprehensive list of determining if title V is unnecessarily CFR 71.6(a)(3). We acknowledge that requirements imposed on part 70 burdensome is whether there are title V might impose additional sources (hence, burden on sources), see implementation and enforcement compliance requirements on this the requirements of 40 CFR 70.3, 70.5, programs in place that are sufficient to category, but we have determined that 70.6, and 70.7. assure compliance with the NESHAP the monitoring, recordkeeping and In assessing the second factor for clay without relying on title V permits. There reporting requirements of the proposed ceramics manufacturing facilities, we are State programs in place to enforce NESHAP for clay ceramics found that 34 of the 51 plants affected this area source NESHAP, and we manufacturing are sufficient to assure by the proposed rule are small believe that the State programs are compliance with the provisions of the businesses, most with only 100 or fewer sufficient to assure compliance with this NESHAP, and title V would not employees. These small sources lack the NESHAP. We also noted that EPA significantly improve those compliance technical resources needed to retains authority to enforce this requirements. comprehend and comply with NESHAP anytime under CAA sections For the second factor, we determine permitting requirements and the 112, 113 and 114. We further noted that whether title V permitting would financial resources needed to hire the small business assistance programs necessary staff or outside consultants. required by CAA section 507 may be impose a significant burden on the area As discussed above, title V permitting used to assist area sources that have sources in the category and whether that would impose significant costs on these been exempted from title V permitting. burden would be aggravated by any area sources, and, accordingly, we Also, States and EPA often conduct difficulty the source may have in conclude that title V is a significant voluntary compliance assistance, obtaining assistance from the permitting burden for sources in this category. outreach, and education programs agency. Subjecting any source to title V Most are small businesses with limited (compliance assistance programs), permitting imposes certain burdens and resources, and under title V they would which are not required by statute. We costs that do not exist outside of the title be subject to numerous mandatory determined that these additional V program. EPA estimated that the activities with which they would have programs will supplement and enhance average cost of obtaining and complying difficulty complying, whether they were the success of compliance with this area with a title V permit was $38,500 per issued a standard or a general permit. source NESHAP. We believe that the source for a 5-year permit period, Furthermore, given the number of statutory requirements for including fees. See Information sources in the category and the implementation and enforcement of this Collection Request for Part 70 Operating relatively small size of many of those NESHAP by the delegated States and Permit Regulations, January 2000, EPA sources, it would likely be difficult for EPA and the additional assistance ICR Number 1587.05. EPA does not them to obtain assistance from the programs described above together are have specific estimates for the burdens permitting authority. Thus, we find that sufficient to assure compliance with this and costs of permitting clay ceramics factor two strongly supports title V area source NESHAP without title V manufacturing area sources; however, exemption for clay ceramics permits. there are certain activities associated manufacturing facilities. In applying the fourth factor in the with the part 70 and 71 rules. These The third factor, which is closely Exemption Rule, where EPA had activities are mandatory and impose related to the second factor, is whether deferred action on the title V exemption burdens on the facility. They include the costs of title V permitting for these for several years, we had enforcement reading and understanding permit area sources would be justified, taking data available to demonstrate that States program guidance and regulations; into consideration any potential gains in were not only enforcing the provisions obtaining and understanding permit compliance likely to occur for such of the area source NESHAP that we application forms; answering follow-up sources. We explained above under the exempted, but that the States were also questions from permitting authorities second factor that the costs of providing compliance assistance to after the application is submitted; compliance with title V would impose assure that the area sources were in the reviewing and understanding the a significant burden on most of the 51 best position to comply with the permit; collecting records; preparing clay ceramics manufacturing facilities NESHAP. See 70 FR 75325–75326. In and submitting monitoring reports on a affected by the proposed rule. We also proposing this rule, we do not have 6-month or more frequent basis; concluded in considering the first factor similar data available on the specific preparing and submitting prompt that, while title V might impose enforcement as in the Exemption rule, deviation reports, as defined by the additional requirements, the but we have no reason to think that State, which may include a combination monitoring, recordkeeping and States will be less diligent in enforcing of written, verbal, and other reporting requirements in the proposed this NESHAP. See 70 FR 75326. In fact, communications methods; collecting NESHAP assure compliance with the States must have adequate programs to information, preparing, and submitting equipment standard and management enforce the section 112 regulations and the annual compliance certification; practices imposed in the NESHAP. In provide assurances that they will preparing applications for permit addition, below in our consideration of enforce all NESHAP before EPA will revisions every 5 years; and, as needed, the fourth factor, we find that there are delegate the program. See 40 CFR part preparing and submitting applications adequate implementation and 63, subpart E. for permit revisions. In addition, enforcement programs in place to assure In light of all of the above, we although not required by the permit compliance with the NESHAP. Because conclude that there are implementation rules, many sources obtain the the costs of compliance with title V are and enforcement programs in place that contractual services of consultants to so high, and the potential for gains in are sufficient to assure compliance with help them understand and meet the compliance is low, title V permitting is the Clay Ceramics Manufacturing permitting program’s requirements. The not justified for this source category. NESHAP without relying on title V ICR for part 70 provides additional Accordingly, the third factor supports permitting.

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Balancing the four factors for this area with the requirements. In this case, would include certifications by source category strongly supports the however, placing all requirements for responsible officials that the facilities proposed finding that title V is the sources in a title V permit would do are in compliance and will continue to unnecessarily burdensome. While title little to clarify the requirements comply with the NESHAP. In addition, V might add additional compliance applicable to the sources or assist them the affected facilities must maintain requirements if imposed, we conclude in compliance with those requirements records showing compliance with the that there would not be significant because of the simplicity of the sources required monitoring. The required improvements to the compliance and the NESHAP, and the fact that these records are similar to the information requirements in the NESHAP because sources are not subject to other that must be provided in the deviation the requirements in this proposed rule NESHAP. We have no reason to think reports required under 40 CFR 70.6(a)(3) are specifically designed to assure that new sources would be substantially and 40 CFR 71.6(a)(3). We believe that compliance with the standards and different from the existing sources. In these requirements are adequate to management practices imposed on this addition, we explained in the assure compliance with the provisions area source category. We also conclude Exemption Rule that requiring permits of the NESHAP. that the costs of compliance with title V, for the large number of area sources We acknowledge that title V includes in conjunction with the likely difficulty could, at least in the first few years of some reporting requirements that are this number of small sources would implementation, potentially adversely not in the proposed NESHAP, including have obtaining assistance from the affect public health, welfare, or the requirements for a 6-month monitoring permitting authority, would impose a environment by shifting State agency report, deviation reports, and an annual significant burden on the sources. We resources away from assuring certification in 40 CFR 70.6 and 71.6. determined that the high relative costs compliance for major sources with However, as described above, we have would not be justified given that there existing permits to issuing new permits determined that the monitoring, is likely to be little or no potential gain for these area sources, potentially recordkeeping and reporting in compliance if title V were required. reducing overall air program requirements under the proposed And, finally, there are adequate effectiveness. Based on the above NESHAP are sufficient to assure implementation and enforcement analysis, we conclude that title V compliance with the provisions of the programs in place to assure compliance exemptions for the clay ceramics NESHAP. Therefore, we do not believe with the NESHAP. Thus, we conclude manufacturing area sources will not that these additional title V reporting that title V permitting is ‘‘unnecessarily adversely affect public health, welfare, requirements would result in significant burdensome’’ for the Clay Ceramics or the environment for all of the reasons improvements to the compliance Manufacturing area source category. explained above. requirements. In addition to evaluating whether For the foregoing reasons, we are Under the second factor, we compliance with title V requirements is proposing to exempt the Clay Ceramics determined whether title V permitting ‘‘unnecessarily burdensome’’, EPA also Manufacturing area source category would impose a significant burden on considered, consistent with guidance from title V permitting requirements. the area sources in the category and provided by the legislative history of whether that burden would be B. Secondary Nonferrous Metal section 502(a), whether exempting the aggravated by any difficulty the source Processing Clay Ceramics Manufacturing area may have in obtaining assistance from source category from title V We compared the title V monitoring, the permitting agency. Subjecting any requirements would adversely affect recordkeeping, and reporting source to title V permitting imposes public health, welfare, or the requirements (factor one) to such certain burdens and costs that do not environment. Exemption of the Clay requirements in the NESHAP for the exist outside of the title V program. EPA Ceramics Manufacturing area source Secondary Nonferrous Metal Processing estimated that the average cost of category from title V requirements area source category. The proposed rule obtaining and complying with a title V would not adversely affect public requires that the affected sources permit was $38,500 per source for a 5- health, welfare, or the environment conduct weekly monitoring of the year permit period, including fees. (See because the level of control would required control device (i.e., baghouse Information Collection Request for Part remain the same if a permit were or fabric filter) for existing sources and 70 Operating Permit Regulations, required. The title V permit program continuous monitoring of the required January 2000, EPA ICR Number does not impose new substantive air control device for new sources. As 1587.05.) EPA does not have specific quality control requirements on sources, discussed above, we believe that these estimates for the burdens and costs of but instead requires that certain monitoring requirements are adequate to permitting secondary nonferrous metal procedural measures be followed, assure compliance with the control processing area sources; however, there particularly with respect to determining requirements specified in the proposed are certain source activities associated compliance with applicable NESHAP. The monitoring component of with the part 70 and 71 rules. These requirements. As stated in our the first factor favors title V exemption activities are mandatory and impose consideration of factor one for this because this proposed standard burdens on the source. They include category, title V would not lead to provides monitoring that assures reading and understanding permit significant improvements in the compliance with the requirements of the program guidance and regulations; compliance requirements applicable to proposed rule. obtaining and understanding permit existing or new area sources. We also considered the extent to application forms; answering follow-up Furthermore, one of the primary which title V could potentially enhance questions from permitting authorities purposes of the title V permitting compliance for area sources covered by after the application is submitted; program is to clarify, in a single this NESHAP through recordkeeping or reviewing and understanding the document, the various and sometimes reporting requirements. For any affected permit; collecting records; preparing complex regulations that apply to secondary nonferrous metal processing and submitting monitoring reports on a sources in order to improve area source facility, the proposed 6-month or more frequent basis; understanding of these requirements NESHAP requires an initial notification preparing and submitting prompt and to help sources achieve compliance and a compliance status report, which deviation reports, as defined by the

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State, which may include a combination compliance requirements would not promulgated and enforced, we have no of written, verbal, and other significantly improve compliance with reason to think that States will be less communications methods; collecting this NESHAP. In addition, in our diligent in enforcing NESHAP. information, preparing, and submitting consideration of the fourth factor as In light of all of the above, we the annual compliance certification; discussed below, we find that there are conclude that there are implementation preparing applications for permit adequate implementation and and enforcement programs in place that revisions every 5 years; and, as needed, enforcement programs in place to assure are sufficient to assure compliance with preparing and submitting applications compliance with the NESHAP. Because the Secondary Nonferrous Metal for permit revisions. In addition, the costs, both economic and non- Processing NESHAP without relying on although not required by the permit economic, of compliance with title V are title V permitting. rules, many sources obtain the so high, and the potential for gains in Based on our assessment of the four contractual services of professional compliance is low, title V permitting is factors as described above, we find that, scientists and engineers (consultants) to not justified for this source category. when considered together, the four help them understand and meet the Accordingly, the third factor supports factors demonstrate that compliance permitting program’s requirements. The title V exemptions for secondary with title V would be unnecessarily ICR for part 70 provides additional nonferrous metal processing area burdensome for sources in the information on the overall burdens and sources. Secondary Nonferrous Metals costs, as well as the relative burdens of The fourth factor we considered in Processing area source category. While each activity described here. Also, for a determining whether title V permitting title V might add additional compliance more comprehensive list of for the Secondary Nonferrous Metals requirements, we believe that there requirements imposed on part 70 Processing area source category is would not be significant improvements sources (hence, burden on sources), see unnecessarily burdensome is whether to compliance with the NESHAP the requirements of 40 CFR 70.3, 70.5, there are implementation and because the requirements in this 70.6, and 70.7. enforcement programs in place that are proposed rule assure compliance with In assessing the second factor for sufficient to assure compliance with this the standards. Furthermore, there are secondary nonferrous metal processing NESHAP without relying on title V adequate implementation and facilities, we found that 6 of the 10 permits. There are State programs in enforcement programs in place to assure plants are small businesses, most with place to enforce this area source compliance with the NESHAP. On the only a few employees. These small NESHAP, and we believe that these other hand, the economic and non- sources lack the technical resources State programs are sufficient to assure economic costs of compliance with title needed to comply with permitting compliance with this NESHAP. V, would impose a significant burden requirements and the financial Furthermore, EPA retains authority to on the sources. We believe that the high resources needed to hire the necessary enforce this NESHAP anytime under relative costs would not be justified staff or outside consultants. As CAA sections 112, 113 and 114. In given that there is likely to be little or discussed above, title V permitting addition to the State programs and no potential gain in compliance if title would impose significant economic and EPA’s authorities to implement and V were required. Based on these non-economic costs on these area enforce this NESHAP, small business considerations, we conclude that title V sources, and, accordingly, we conclude assistance programs required by CAA permitting is ‘‘unnecessarily that title V is a significant burden for section 507 may be used to assist area burdensome’’ for the Secondary sources in this category. In addition, sources that have been exempted from Nonferrous Metal Processing area source many of the sources in this area source title V permitting. Also, States and EPA category. category are small businesses. Under often conduct voluntary compliance In addition to evaluating whether title V, they would be subject to assistance, outreach, and education compliance with title V requirements is numerous mandatory activities, and programs (compliance assistance ‘‘unnecessarily burdensome’’, EPA because of limited resources, they programs), which are not required by considered, consistent with guidance would have difficulty complying, statute. We believe that the statutory provided by the legislative history of whether they were issued a standard or requirements for implementation and section 502(a), whether exempting the a general permit. Thus, we find that enforcement of this NESHAP by the Secondary Nonferrous Metal Processing factor two supports title V exemption delegated States and EPA and the area source category from title V for secondary nonferrous metal additional assistance programs requirements would adversely affect processing facilities. described above together are sufficient public health, welfare, or the The third factor, which is closely to assure compliance with this area environment. Exemption of the related to the second factor, is whether source NESHAP without title V permits. Secondary Nonferrous Metal Processing the costs of title V permitting for these Furthermore, in applying the fourth area source category from title V area sources would be justified, taking factor in the Exemption Rule, where requirements would not adversely affect into consideration any potential gains in EPA had deferred action on the title V public health, welfare, or the compliance likely to occur for such exemption for several years, we had environment because the level of sources. We explained above under the enforcement data demonstrating that control would remain the same even if second factor that the economic and States were not only enforcing the a permit were required. The title V non-economic costs of compliance with provisions of those area source permit program does not impose new title V would impose a significant NESHAP, but that the States were also substantive air quality control burden on many secondary nonferrous providing compliance assistance to requirements on sources, but instead metal processing facilities. We also assure that the area sources were in the requires that certain procedural concluded in considering the first factor best position to comply with the measures be followed, particularly with that the monitoring and recordkeeping NESHAP. See 70 FR 75325–75326. respect to determining compliance with requirements in the NESHAP are Although we do not have similar data in applicable requirements. As stated in adequate to assure compliance with the this case because the Secondary our consideration of factor one for this management practices proposed in the Nonferrous Metals Processing area category, title V would not lead to NESHAP and that the additional title V source NESHAP has yet to be significant improvements in the

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compliance requirements applicable to filters would be installed on two we estimate that this proposed rule existing or new area sources. pressed and blown glass furnaces. would have no impacts on solid waste Furthermore, one of the primary We project that, during the first 3 generation. years of the proposed standard, nine purposes of the title V permitting 3. Energy Impacts program is to clarify, in a single new furnaces would be constructed and document, the various and sometimes that all nine furnaces would be in the Energy impacts consist of the complex regulations that apply to container glass sector. Because none of electricity and fuel needed to operate sources in order to improve these new furnaces are expected to use control devices and other equipment understanding of these requirements any of the glass manufacturing metal that would be required under the and to help sources to achieve HAP as raw materials, we project that proposed rule. We assume that affected compliance with the requirements. In none of the nine new furnaces would be facilities would comply with the rule as this case, however, placing all affected by this proposed rule. proposed by installing and operating requirements for the sources in a title V Therefore, we estimate that this either ESP or fabric filters which require permit would do little to clarify the proposed rule would have no air quality electricity to operate. Specifically, we requirements applicable to the sources impacts on new sources. assumed that an ESP would be installed or assist them in compliance with those Indirect or secondary air impacts of on one pressed and blown glass furnace, requirements because of the simplicity this rule as proposed would result from and that fabric filters would be installed of the sources and the NESHAP, and the the increased electricity usage on two pressed and blown glass fact that these sources are not subject to associated with the operation of control furnaces. Under this scenario, we other NESHAP or to other requirements devices. Assuming that plants would project that this rule as proposed would under the CAA. We have no reason to purchase electricity from a power plant, increase overall energy demand (i.e., we estimate that the standards as think that new sources would be electricity demand) for existing sources proposed would increase secondary substantially different from the existing by about 1,160 megawatt-hours per year, emissions of criteria pollutants, sources. In addition, we explained in or 7.1 thousand gigajoules per year (6.7 including PM, sulfur dioxide (SO ), the Exemption Rule that requiring 2 billion British thermal units per year). nitrogen oxides (NO ), and carbon permits could, at least in the first few X We estimate that none of the nine new monoxide (CO) from power plants. For years of implementation, potentially sources projected to go into operation three existing sources that would be adversely affect public health, welfare, during the first 3 years of the standard required to install emission controls, the or the environment by shifting State would be affected by this proposed rule. proposed rule would increase secondary agency resources away from assuring Therefore, we are not expecting any PM emissions by 0.28 Mg/yr (0.31 tpy); compliance for major sources with energy impacts for new sources. secondary SO emissions by about 11.1 existing permits to issuing new permits 2 4. Cost Impacts Mg/yr (12.2 tpy); secondary NOX for these area sources, potentially emissions by about 5.5 Mg/yr (6.1 tpy); The estimated total capital costs of reducing overall air program and secondary CO emissions by about this proposed rule for existing sources effectiveness. We therefore conclude 0.18 Mg/yr (0.20 tpy). are $1.42 million. These capital costs that title V exemptions for the For the estimated nine new sources include the costs to purchase and install secondary nonferrous metal processing within the Glass Manufacturing ESP or fabric filters on the three affected area sources will not adversely affect industry over the next 3 years, we furnaces that are not currently public health, welfare, or the estimate no secondary air impacts controlled. The estimated annualized environment for all of the reasons because we project that none of the new cost of the proposed rule for existing explained above. sources would be affected sources under sources would be $491,000 per year. For the foregoing reasons, we are this proposed rule. The annualized costs account for the proposing to exempt the Secondary 2. Water and Solid Waste Impacts annualized capital costs of the control Nonferrous Metal Processing area source and monitoring equipment, operation category from title V permitting To comply with the rule as proposed, and maintenance expenses, performance requirements. we expect that affected facilities would testing, and recordkeeping costs for the control emissions by installing and VII. What are the impacts of the three existing facilities within the operating ESP or fabric filters, neither of proposed standards for area sources? source category that would be required which generates wastewater. Therefore, to install new emission controls. The A. Glass Manufacturing we project that this rule as proposed other affected facilities would incur would have no water impacts. Glass 1. Air Quality Impacts costs only for submitting the manufacturers typically purchase highly notifications and for annual control For the three sources that would be refined and purified raw materials, and device inspections because those required to install emission controls to they usually recycle internal captured facilities already meet the testing, meet the emission limits specified in baghouse and ESP fines into the raw monitoring, and recordkeeping this proposed rule, we estimated material to be fed back into the furnace. requirements that would be required nationwide emissions of the glass Therefore, we expect the solid waste under the proposed rule. manufacturing metal HAP to be 26.2 impacts to be far less than if facilities We estimate that none of the nine new Mg/yr (28.9 tpy). We estimate that the were to dispose of their ESP and sources projected to go into operation rule as proposed would reduce baghouse fines. We estimate that the during the first 3 years of the standard nationwide emissions of the glass proposed rule would generate 37.7 Mg/ would be affected sources under this manufacturing metal HAP by about 25.6 yr (41.6 tpy) of solid waste from existing proposed rule. Therefore, we estimate Mg/yr (28.2 tpy). This proposed rule sources. These estimates are based on no cost impacts for new sources. would also reduce emissions of PM by the assumption that an ESP would be 377 Mg/yr (415 tpy). These estimates are installed on one pressed and blown 5. Economic Impacts based on the assumption that an ESP glass furnace, and that fabric filters Both the magnitude of control costs would be installed on one pressed and would be installed on two pressed and needed to comply with the proposed blown glass furnace, and that fabric blown glass furnaces. For new sources, rule and the distribution of these costs

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among affected facilities can have an VIII. Statutory and Executive Order new clay ceramics manufacturing area impact in determining how the market Reviews sources because no new area sources are would change in response to the rule. projected for the next 3 years. A. Executive Order 12866: Regulatory The proposed NESHAP for Glass Total annualized costs for this proposed Planning and Review rule are estimated to be approximately Manufacturing also would require $0.48 million. Only three facilities are Under Executive Order 12866 (58 FR applicable one-time notifications estimated to require additional capital 51735, October 4, 1993), this action is a required by the NESHAP General costs because of the proposed rule. ‘‘significant regulatory action’’ because Provisions, monitoring of control device it may raise novel legal or policy issues. parameters, and recordkeeping. The We obtained revenue data for two of Accordingly, EPA submitted this action annual burden for this collection of the three companies that operate to OMB for review under Executive information averaged over the first 3 facilities that would be required to Order 12866, and any changes made in years of this ICR is estimated to total install emission controls under this response to OMB recommendations 190 labor hours per year at a cost of proposed rule. Based on those data, have been documented in the docket for $16,130 for the 21 glass manufacturing cost-to-sales estimates for those two this action. area source facilities that would be affected facilities would be 0.66 percent B. Paperwork Reduction Act subject to this proposed rule. This and 1.0 percent, respectively. Revenue burden estimate includes time for data were not available for the other The information collection acquisition, installation, and use of facility that would be affected by the requirements in the proposed NESHAP monitoring technology and systems, proposed rule, so the national average for Clay Ceramics Manufacturing Area one-time notifications, and value of shipments per worker from the Sources, Glass Manufacturing Area recordkeeping. Total capital/startup 2002 Census of Manufacturers was used Sources, and Secondary Nonferrous costs associated with the monitoring along with the average number of Metals Processing Area Sources have requirements (e.g., costs for hiring workers per facility to estimate been submitted for approval to OMB performance test contractors and revenues. The resulting costs for this under the Paperwork Reduction Act, 44 purchase of monitoring and file storage and the other two facilities are relatively U.S.C. 3501 et seq. The Information equipment) over the 3-year period of the small and are not expected to result in Collection Request (ICR) document ICR are estimated at $15,990, with a significant market impact whether prepared by EPA has been assigned EPA operation and maintenance costs of they are passed on to the purchaser or ICR No. 2274.01. $9,850/yr. No costs or burden estimates absorbed by the company. The recordkeeping and reporting are estimated for new sources because requirements in the proposed rule is no new sources are project for the next B. Clay Ceramics Manufacturing based on the information collection 3 years. requirements in the part 63 General Unlike the glass manufacturing The proposed NESHAP for Secondary Provisions (40 CFR part 63, subpart A). industry, which still has some Nonferrous Metals Processing area These recordkeeping and reporting uncontrolled sources of urban HAP, sources requires one-time notifications requirements are mandatory pursuant to sources in the clay ceramics required by the NESHAP General section 114 of the CAA (42 U.S.C. 7414). manufacturing source category have Provisions. Plant owners or operators All information submitted to EPA made significant emission reductions would be required to conduct pursuant to the information collection through process changes and performance tests and include requirements for which a claim of installation of control equipment. compliance certifications for the percent confidentiality is made is safeguarded Affected sources are well-controlled and PM reduction achieved by the required according to EPA’s implementing control device in their Notifications of our proposed GACT determination regulations at 40 CFR part 2, subpart B. Compliance Status. The affected reflects such controls. We estimate that The proposed NESHAP for Clay facilities are expected to already have the only impact to affected sources is Ceramics Manufacturing area sources the required control and monitoring the labor burden associated with the requires applicable one-time equipment in place and already conduct proposed reporting and recordkeeping notifications required by the NESHAP the required monitoring and requirements. The cost associated with General Provisions. Plant owners or recordkeeping activities. recordkeeping and the one-time operators would be required to include The annual burden for this reporting requirements is estimated to compliance certifications for the information collection averaged over the be $974 per facility. management practices in their first 3 years of this ICR is estimated to C. Secondary Nonferrous Metals Notifications of Compliance Status. The total 15 labor hours per year at a cost of Processing affected facilities are expected to approximately $1,300 for 3 existing already have the required control and secondary nonferrous metals processing Similar to the clay ceramics monitoring equipment in place and area sources (10 existing sources manufacturing industry, all of the already conduct the required monitoring averaged over 3 years). No capital/ affected sources in the secondary and recordkeeping activities. startup costs or operation and nonferrous metal processing category The annual burden for this maintenance costs are associated with have installed control equipment on information collection averaged over the the proposed information collection their furnace melting operations and are first 3 years of this ICR is estimated to requirements. No costs or burden hours well-controlled. Affected sources are total 196 labor hours per year at a cost are estimated for new secondary well-controlled and our proposed GACT of approximately $16,600 for 17 existing nonferrous metals processing area determinations reflect such controls. We clay ceramics manufacturing area sources because no new area sources are estimate that the only impact associated sources (51 existing sources averaged projected for the next 3 years. with the proposed rule is the reporting over 3 years). No capital/startup costs or Burden means the total time, effort, or and recordkeeping requirements. The operation and maintenance costs are financial resources expended by persons cost associated with recordkeeping and associated with the proposed to generate, maintain, retain, or disclose the one-time reporting requirements is information collection requirements. No or provide information to or for a estimated to be $390 per facility. costs or burden hours are estimated for Federal agency. This includes the time

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needed to review instructions; develop, small not-for-profit enterprises, and Twenty one glass manufacturing acquire, install, and utilize technology small governmental jurisdictions. facilities are estimated to require and systems for the purposes of For the purposes of assessing the additional costs because of the proposed collecting, validating, and verifying impacts of the proposed area source rule. None of these facilities are small information, processing and NESHAP on small entities, small entity businesses. Therefore, there is no maintaining information, and disclosing is defined as: (1) A small business significant impact on a substantial and providing information; adjust the whose parent company meets the Small number of small entities. existing ways to comply with any Business Administration size standards We continue to be interested in the previously applicable instructions and for small businesses found at 13 CFR potential impacts of the proposed action requirements; train personnel to be able 121.201 (less than 500 to 750 employees on small entities and welcome to respond to a collection of for Clay Ceramics Manufacturing, less comments on issues related to such information; search data sources; than 750 to 1,000 employees for Glass impacts. complete and review the collection of Manufacturing, and less than 750 D. Unfunded Mandates Reform Act information; and transmit or otherwise employees for Secondary Nonferrous Title II of the Unfunded Mandates disclose the information. Metals Processing, depending on the Reform Act of 1995 (UMRA), Public An agency may not conduct or size definition for the affected NAICS Law 104–4, establishes requirements for sponsor, and a person is not required to, code); (2) a small governmental Federal agencies to assess the effects of respond to a collection of information jurisdiction that is a government of a their regulatory actions on State, local, unless it displays a currently valid OMB city, county, town, school district, or and tribal governments and the private control number. The OMB control special district with a population of less sector. Under section 202 of the UMRA, numbers for EPA’s regulations in 40 than 50,000; and (3) a small EPA generally must prepare a written CFR part 63 are listed in 40 CFR part 9. organization that is any not-for-profit statement, including a cost-benefit To comment on EPA’s need for this enterprise, which is independently analysis, for proposed and final rules information, the accuracy of the owned and operated and is not with ‘‘Federal mandates’’ that may provided burden estimates, and any dominant in its field. result in expenditures by State, local, suggested methods for minimizing Based on our estimates, EPA does not and tribal governments, in the aggregate, respondent burden, including the use of expect any new clay ceramic or or to the private sector, of $100 million automated collection techniques, EPA secondary nonferrous metal processing or more in any 1 year. Before has established a public docket for this sources to be constructed in the promulgating an EPA rule for which a action, which includes this ICR, under foreseeable future and so therefore did written statement is needed, section 205 Docket ID numbers EPA–HQ–OAR– not estimate the impacts for new clay of the UMRA generally requires EPA to 2006–0424 (for Clay Ceramics ceramics manufacturing or secondary identify and consider a reasonable Manufacturing), EPA–HQ–OAR–2006– nonferrous metal processing sources. number of regulatory alternatives and 0360 (for Glass Manufacturing), and After considering the economic impacts adopt the least costly, most cost- EPA–HQ–OAR–2006–0940 (for of today’s proposed rules on small effective, or least burdensome Secondary Nonferrous Metals entities, I certify that this action will not alternative that achieves the objectives Processing). Submit any comments have a significant economic impact on of the rule. The provisions of section related to the ICR for the proposed rule a substantial number of small entities. 205 do not apply when they are to EPA and OMB. See the ADDRESSES There would be no significant impacts inconsistent with applicable law. section at the beginning of this preamble on new or existing clay ceramics Moreover, section 205 allows EPA to for where to submit comments to EPA. manufacturing facilities or secondary adopt an alternative other than the least Send comments to OMB at the Office of nonferrous metals processing facilities costly, most cost-effective, or least Information and Regulatory Affairs, because these proposed rules do not burdensome alternative if the Office of Management and Budget, 725 create any new requirements or burdens Administrator publishes with the final 17th Street, NW., Washington, DC other than minimal notification rule an explanation why that alternative 20503, Attention: Desk Office for EPA. requirements. The minimal notification was not adopted. Before EPA establishes Because OMB is required to make a requirements consist of reading the rule any regulatory requirements that may decision concerning the ICR between 30 and providing two initial notifications significantly or uniquely affect small and 60 days after September 20, 2007, to EPA: One notifying EPA that the governments, including tribal a comment to OMB is best assured of facility is subject to the rule and one governments, it must have developed having its full effect if OMB receives it notifying EPA that the facility is in under section 203 of the UMRA a small by October 22, 2007. The final rules will compliance with the rule. These government agency plan. The plan must respond to any OMB or public notifications may be submitted together. provide for notifying potentially comments on the information collection We estimate the cost of these one time affected small governments, enabling requirements contained in the proposal. notification requirements to be $974 for officials of affected small governments each clay ceramics manufacturing C. Regulatory Flexibility Act to have meaningful and timely input in facility and $390 for each secondary the development of EPA regulatory The Regulatory Flexibility Act nonferrous metals processing facility. proposals with significant Federal generally requires an agency to prepare These costs were estimated based on the intergovernmental mandates, and a regulatory flexibility analysis of any costs of technical, management, and informing, educating, and advising rule subject to notice and comment clerical support salaries. We also small governments on compliance with rulemaking requirements under the estimate that 34 clay ceramics facilities the regulatory requirements. Administrative Procedure Act or any and 6 secondary nonferrous metals EPA has determined that the other statute unless the agency certifies processing facilities are owned and proposed rules do not contain a Federal that the rule would not have a operated by small businesses. These mandate that may result in expenditures significant economic impact on a notification costs would be less than of $100 million or more for State, local, substantial number of small entities. 0.25 percent for any of these small and tribal governments, in the aggregate, Small entities include small businesses, businesses. or to the private sector in any 1 year.

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Thus, the proposed rules are not subject power and responsibilities between the in Executive Order 13211 (66 FR 28355, to the requirements of sections 202 and Federal government and Indian tribes, May 22, 2001) because they are not 205 of the UMRA. In addition, the as specified in Executive Order 13175. likely to have a significant adverse effect proposed rules do not significantly or The proposed rules impose on the supply, distribution, or use of uniquely affect small governments. The requirements on owners and operators energy. Further, we have concluded that proposed rules contain no requirements of specified area sources and not tribal these proposed rules are not likely to that apply to such governments, impose governments. Thus, Executive Order have any adverse energy effects. The no obligations upon them, and would 13175 does not apply to the proposed energy requirements for these industries not result in expenditures by them of rules. EPA specifically solicits would remain at existing levels. No $100 million or more in any 1 year or additional comments on the proposed additional pollution controls or other any disproportionate impacts on them. rules from tribal officials. equipment that would consume energy Therefore, the proposed rules are not G. Executive Order 13045: Protection of are required by these proposed rules. subject to section 203 of the UMRA. Children From Environmental Health I. National Technology Transfer E. Executive Order 13132: Federalism and Safety Risks Advancement Act Executive Order 13132 (64 FR 43255, Executive Order 13045: ‘‘Protection of Section 12(d) of the National August 10, 1999) requires EPA to Children from Environmental Health Technology Transfer and Advancement develop an accountable process to Risks and Safety Risks’’ (62 FR 19885, Act (NTTAA) of 1995 (Pub. L. 104–113, assure ‘‘meaningful and timely input by April 23, 1997) applies to any rule that: 15 U.S.C. 272 note) directs EPA to use State and local officials in the (1) Is determined to be ‘‘economically voluntary consensus standards (VCS) in development of regulatory policies that significant’’ as defined under Executive its regulatory activities, unless to do so have federalism implications.’’ ‘‘Policies Order 12866, and (2) concerns an would be inconsistent with applicable that have federalism implications’’ are environmental health or safety risk that law or otherwise impractical. The VCS defined in the Executive Order to EPA has reason to believe may have a are technical standards (e.g., materials include regulations that have disproportionate effect on children. If specifications, test methods, sampling ‘‘substantial direct effects on the States, the regulatory action meets both criteria, procedures, and business practices) that on the relationship between the national EPA must evaluate the environmental are developed or adopted by VCS government and the States, or on the health or safety effects of the planned bodies. The NTTAA directs EPA to distribution of power and rule on children, and explain why the provide Congress, through OMB, responsibilities among the various planned regulation is preferable to other explanations when EPA does not use levels of government.’’ potentially effective and reasonably available and applicable VCS. The proposed rules do not have feasible alternatives considered by EPA. The proposed rule as it applies to federalism implications. They would EPA interprets Executive Order 13045 glass manufacturing involves technical not have substantial direct effects on the as applying only to those regulatory standards. EPA cites the following States, on the relationship between the actions that are based on health or safety standards: EPA Methods 1, 1A, 2, 2A, national government and the States, or risks, such that the analysis required 2C, 2F, 2G, 3, 3A, 3B, 4, 5, 17, and 22 on the distribution of power and under section 5–501 of the Executive in 40 CFR part 60, appendix A. responsibilities among the various Order has the potential to influence the levels of government, as specified in regulation. The proposed rules are not Consistent with the NTTAA, EPA Executive Order 13132. The proposed subject to Executive Order 13045 conducted searches to identify VCS in rules impose requirements on owners because they are based on technology addition to these EPA methods. No and operators of specified area sources performance and not on health or safety applicable VCS were identified for EPA and not State and local governments. risks. Methods 1A, 2A, 2F, 2G, and 22. The Thus, Executive Order 13132 does not search and review results are in the H. Executive Order 13211: Actions apply to the proposed rules. dockets for the proposed rules. In the spirit of Executive Order 13132, Concerning Regulations That The search identified one VCS as an and consistent with EPA policy to Significantly Affect Energy Supply, acceptable alternative to EPA methods. promote communications between EPA Distribution, or Use The standard ASME PTC 19.10–1981, and State and local governments, EPA The glass manufacturing rule is not a ‘‘Flue and Exhaust Gas Analyses,’’ is specifically solicits comments on these ‘‘significant energy action’’ as defined in cited in the proposed rule for glass proposed rules from State and local Executive Order 13211, ‘‘Actions manufacturing area sources for its officials. Concerning Regulations That manual method for measuring the Significantly Affect Energy Supply, oxygen, carbon dioxide, and carbon F. Executive Order 13175: Consultation Distribution, or Use’’ (66 FR 28355, May monoxide content of the exhaust gas. and Coordination With Indian Tribal 22, 2001) because it is not likely to have This part of ASME PTC 19.10–1981 is Governments a significant adverse effect on the an acceptable alternative to EPA Method Executive Order 13175 (65 FR 67249, supply, distribution, or use of energy. 3B. November 6, 2000), requires EPA to Further, we have concluded that this The search for emissions develop an accountable process to proposed rule is not likely to have any measurement procedures identified 14 assure ‘‘meaningful and timely input by significant adverse energy effects. other VCS. EPA determined that these tribal officials in the development of Existing energy requirements for this 14 standards identified for measuring regulatory policies that have tribal industry would not be significantly emissions of the HAP or surrogates implications.’’ The proposed rules do impacted by the additional pollution subject to emission standards in the not have tribal implications, as specified controls or other equipment that may be Glass Manufacturing proposed rule were in Executive Order 13175. They would required by this proposed rule. impractical alternatives to EPA test not have substantial direct effects on The clay ceramics manufacturing and methods for the purposes of the rule. tribal governments, on the relationship the secondary nonferrous metals Therefore, EPA does not intend to adopt between the Federal government and processing proposed rules are not these standards for this purpose. The Indian tribes, or on the distribution of ‘‘significant energy actions’’ as defined reasons for the determinations for the 14

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methods are included in the docket for Dated: September 12, 2007. 63.11445 Who implements and enforces the Glass Manufacturing proposed rule. Stephen L. Johnson, this subpart? 63.11446—63.11447 [Reserved] Sections 63.11440 and 63.11452 list Administrator. the test methods included in the For the reasons stated in the Tables to Subpart RRRRRR of Part 63 preamble, title 40, chapter I, part 63 of proposed rule. For the methods required Table 1 to Subpart RRRRRR of Part or referenced by the proposed rule, a the Code of Federal Regulations is proposed to be amended as follows: 63—Applicability of General Provisions source may apply to EPA for permission to Subpart RRRRRR to use alternative test methods or PART 63—[AMENDED] alternative monitoring requirements in Subpart RRRRRR—National Emission place of any required testing methods, 1. The authority citation for part 63 Standards for Hazardous Air Pollutants performance specifications, or continues to read as follows: for Clay Ceramics Manufacturing Area procedures under §§ 63.7(f) and 63.8(f) Authority: 42 U.S.C. 7401 et seq. Sources of subpart A of the General Provisions. EPA welcomes comments on this aspect Subpart A—[AMENDED] Applicability and Compliance Dates of the proposed rulemaking and, § 63.11435 Am I subject to this subpart? specifically, invites the public to 2. Section 63.14 is amended by (a) You are subject to this subpart if identify potentially-applicable revising paragraph (i)(1) to read as you own or operate a clay ceramics voluntary consensus standards and to follows: manufacturing facility (as defined in explain why such standards should be § 63.14 Incorporations by reference. § 63.11444), with an atomized glaze used in this regulation. * * * * * spray booth or kiln that fires glazed J. Executive Order 12898: Federal (i) * * * ceramic ware, that processes more than Actions To Address Environmental (1) ANSI/ASME PTC 19.10–1981, 45 megagrams per year (Mg/yr) (50 tons Justice in Minority Populations and ‘‘Flue and Exhaust Gas Analyses [Part per year (tpy)) wet clay and is an area Low-Income Populations 10, Instruments and Apparatus],’’ IBR source of hazardous air pollutant (HAP) approved for §§ 63.309(k)(1)(iii), emissions. Executive Order 12898 (59 FR 7629, 63.865(b), 63.3166(a)(3), (b) If you are an owner or operator of February 16, 1994) establishes Federal 63.3360(e)(1)(iii), 63.3545(a)(3), an area source subject to this subpart, executive policy on environmental 63.3555(a)(3), 63.4166(a)(3), you are exempt from the obligation to justice. Its main provision directs 63.4362(a)(3), 63.4766(a)(3), obtain a permit under 40 CFR part 70 or Federal agencies, to the greatest extent 63.4965(a)(3), 63.5160(d)(1)(iii), 71, provided you are not required to practicable and permitted by law, to 63.9307(c)(2), 63.9323(a)(3), obtain a permit under 40 CFR 70.3(a) or make environmental justice part of their 63.11148(e)(3)(iii), 63.11155(e)(3), 71.3(a) for a reason other than your mission by identifying and addressing, 63.11162(f)(3)(iii) and (f)(4), status as an area source under this as appropriate, disproportionately high 63.11163(g)(1)(iii) and (g)(2), subpart. Notwithstanding the previous and adverse human health or 63.11410(j)(1)(iii), Table 5 of subpart sentence, you must continue to comply environmental effects of their programs, DDDDD of this part, 63.11452(b)(12), with the provisions of this subpart policies, and activities on minority and 63.11466(c)(1)(iii). applicable to area sources. populations and low-income * * * * * populations in the United States. 3. Part 63 is amended by adding 63.11436 What parts of my plant does this subpart cover? EPA has determined that these subpart RRRRRR to read as follows: (a) This subpart applies to any proposed rules will not have Subpart RRRRRR—National Emission disproportionately high and adverse Standards for Hazardous Air Pollutants for existing, new, or reconstructed affected human health or environmental effects Clay Ceramics Manufacturing Area Sources source located at a clay ceramics manufacturing facility. on minority or low-income populations Applicability and Compliance Dates because they increase the level of (b) The affected source includes all Sec. atomized glaze spray booths and kilns environmental protection for all affected 63.11435 Am I subject to this subpart? populations without having any that fire glazed ceramic ware located at 63.11436 What parts of my plant does this a clay ceramics manufacturing facility. disproportionately high and adverse subpart cover? human health or environmental effects 63.11437 What are my compliance dates? (c) An affected source is existing if on any population, including any you commenced construction or Standards, Compliance, and Monitoring reconstruction of the affected source minority or low-income population. Requirements These proposed rules establish national before September 20, 2007. 63.11438 What are the standards for new (d) An affected source is new if you standards for each area source category. and existing sources? EPA welcomes comments on this aspect commenced construction or 63.11439 What are the initial compliance reconstruction of the affected source on of the proposed rulemaking and, demonstration requirements for new and specifically, invites the public to existing sources? or after September 20, 2007. identify potentially-applicable 63.11440 What are the monitoring § 63.11437 What are my compliance voluntary consensus standards and to requirements for new and existing dates? explain why such standards should be sources? 63.11441 What are the notification (a) If you have an existing affected used in this regulation. requirements? source, you must comply with the List of Subjects in 40 CFR Part 63 63.11442 What are the recordkeeping standards no later than the date of requirements? publication of the final rule in the Environmental protection, Air Other Requirements and Information Federal Register. pollution control, Hazardous 63.11443 What General Provisions apply to (b) If you have a new or reconstructed substances, Incorporations by reference, this subpart? affected source, you must comply with Reporting and recordkeeping 63.11444 What definitions apply to this this subpart according to paragraphs requirements. subpart? (b)(1) and (2) of this section.

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(1) If you start up your affected source § 63.11439 What are the initial compliance and baghouse unit for leaks. You must on or before the date of publication of demonstration requirements for new and also inspect the inside of each baghouse the final rule in the Federal Register, existing sources? for structural integrity and fabric filter you must comply with this subpart no (a) You must demonstrate initial condition. You must record the results later than the date of publication of the compliance with the applicable of the inspection and any maintenance final rule in the Federal Register. management practices in § 63.11438 by action in the logbook required in (2) If you start up your affected source submitting a Notification of Compliance paragraph (d) of this section. An initial after the date of publication of the final Status. For any wet spray glaze inspection of the internal components of rule in the Federal Register, you must operations controlled with an APCD, a baghouse is not required if an comply with this subpart upon initial you must conduct an initial inspection inspection has been performed within startup of your affected source. of the control equipment as described in the past 12 months. § 63.11440(b)(1) within 60 days of the (2) Periodic inspections/maintenance. Standards, Compliance, and compliance date and include the results Following the initial inspections, you Monitoring Requirements of the inspection in the Notification of must perform periodic inspections and § 63.11438 What are the standards for new Compliance Status. maintenance of each PM control device and existing sources? (b) You must demonstrate initial according to the requirements in (a) For each kiln that fires glazed compliance with the applicable paragraphs (b)(2)(i) or (ii) of this section. ceramic ware, you must maintain the management practices in § 63.11438 by (i) You must inspect and maintain peak temperature below 1540 °C (2800 submitting the Notification of each wet control system according to °F) and comply with one of the Compliance Status within 120 calendar the requirements in paragraphs management practices in paragraphs days after the applicable compliance (b)(2)(i)(A) through (C) of this section. (a)(1) and (2) of this section: date specified in § 63.11437. (A) You must conduct a daily (1) Use natural gas, or equivalent inspection to verify the presence of § 63.11440 What are the monitoring water flow to the wet control system. clean-burning fuel, as the kiln fuel; or requirements for new and existing sources? (2) Use an electric-powered kiln. (B) You must conduct weekly visual (b) You must maintain annual wet (a) For each kiln firing glazed ceramic inspections of the system ductwork and glaze usage records for your facility. ware, you must conduct a daily check control equipment for leaks. of the peak firing temperature. If the (C) You must conduct inspections of (c) For each atomized glaze spray ° peak temperature exceeds 1540 C (2800 the interior of the wet control system (if booth located at a clay ceramics ° manufacturing facility that uses more F), you must take corrective action applicable) to determine the structural than 227 Mg/yr (250 tpy) of wet glaze(s), according to your standard operating integrity and condition of the control you must comply with the equipment procedures. equipment every 12 months. standard requirements in paragraph (b) For each existing, new, or (ii) You must inspect and maintain (c)(1) of this section or the management reconstructed affected source with an each baghouse according to the practice in paragraph (c)(2) of this atomized glaze spray booth equipped requirements in paragraphs (b)(2)(ii)(A) section. with an APCD, you must demonstrate and (B) of this section. (1) Route the emissions from the compliance by conducting the (A) You must conduct weekly visual atomized glaze spray booth through an monitoring activities in paragraphs inspections of the system ductwork for APCD, as defined in § 63.11444. (b)(1) through (3) of this section: leaks. (i) Operate and maintain the APCD in (1) Initial control device inspection. (B) You must conduct inspections of accordance with the equipment You must conduct an initial inspection the interior of the baghouse for manufacturer’s specifications; of each particulate matter (PM) control structural integrity and to determine the (ii) Monitor the APCD according to device according to the requirements in condition of the fabric filter every 12 the applicable requirements in paragraphs (b)(1)(i) or (ii) of this section. months. § 63.11440. You must conduct each inspection no (3) As an alternative to the monitoring (2) Alternatively, use wet glazes later than 60 days after your applicable activities in paragraph (b)(2) of this containing less than 0.1 (weight) percent compliance date for each installed section, you may demonstrate clay ceramics metal HAP. control device which has been operated compliance by: (d) For each atomized glaze spray within 60 days of the compliance date. (i) Conducting a daily 30-minute booth located at a clay ceramics For an installed control device which visible emissions (VE) test (i.e., no manufacturing facility that uses 227 Mg/ has not been operated within 60 days of visible emissions) using EPA Method 22 yr (250 tpy) or less of wet glaze(s), you the compliance date, you must conduct (40 CFR part 60, appendix A–7); or must comply with one of the an initial inspection prior to startup of (ii) Using an approved alternative management practices in paragraphs the control device. monitoring technique under § 63.8(f). (d)(1) and (2) of this section. (i) For each wet control system, you (c) If the results of the visual (1) Employ waste minimization must verify the presence of water flow inspection, VE test, or alternative practices, as defined in § 63.11444; or to the control equipment. You must also monitoring technique conducted under (2) Alternatively, comply with the visually inspect the system ductwork paragraph (b) of this section indicate an equipment standard requirements and control equipment for leaks and exceedance, you must take corrective described in paragraph (c)(1) of this inspect the interior of the control action according to the equipment section or the management practice equipment (if applicable) for structural manufacturer’s specifications or described in paragraph (c)(2) of this integrity and the condition of the instructions. section. control system. An initial inspection of (d) You must maintain records of your (e) Surface applications (e.g., wet the internal components of a wet control monitoring activities described in glazes) containing less than 0.1 (weight) system is not required if an inspection paragraphs (a) through (c) of this percent clay ceramics metal HAP do not has been performed within the past 12 section. You may use your existing have to be considered in determination months. operating permit documentation to meet of the 227 Mg/yr (250 tpy) threshold for (ii) For each baghouse, you must the monitoring requirements if it wet glaze usage. visually inspect the system ductwork includes, but is not limited to, the

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monitoring records listed in paragraphs associated with wet spray glaze are not limited to, wet scrubbers, fabric (d)(1) through (5) of this section related operations; or filters, water curtains, and water-wash to any kiln peak temperature checks, (ii) Alternatively, you are using wet systems. visual inspections, VE tests, or glazes containing less than 0.1 (weight) Atomization means the conversion of alternative monitoring: percent clay ceramics metal HAP. a liquid into a spray or mist (i.e., (1) The date, place, and time; (4) For atomized glaze spray booths collection of drops), often by passing the (2) Person conducting the activity; located at a clay ceramics liquid through a nozzle. (3) Technique or method used; manufacturing facility that uses 227 Mg/ Clay ceramics manufacturing facility (4) Operating conditions during the yr (250 tpy) or less of wet glaze(s), you means a plant site that manufactures activity; and must certify that: pressed tile, sanitaryware, dinnerware, (5) Results. (i) You are employing waste or pottery. For the purposes of this area minimization practices, as defined in source rule, the following types of § 63.11441 What are the notification facilities are not part of the regulated requirements? § 63.11444; or (ii) You are complying with the category: artisan potters, art studios, (a) You must submit an Initial requirements in § 63.11441(b)(3)(i) or school and university ceramic arts Notification required by § 63.9(a)(2) no (ii). programs, and any facility that uses less later than 120 calendar days after the than 45 Mg/yr (50 tpy) of wet clay. applicable compliance date specified in § 63.11442 What are the recordkeeping Clay ceramics metal HAP means an § 63.11437. The Initial Notification must requirements? oxide or other compound of chromium, include the information specified in (a) You must keep the records lead, manganese, or nickel, which were paragraphs (a)(1) through (4) of this specified in paragraphs (a)(1) and (2) of listed for Clay Ceramics Manufacturing section and may be combined with the this section. in the Revised Area Source Category Notification of Compliance Status (1) A copy of each notification that List (67 FR 70428, November 22, 2002). required in paragraph (b) of this section. you submitted to comply with this Glaze means a coating of colored, (1) The name and address of the subpart, including all documentation opaque, or transparent material applied owner or operator; supporting any Initial Notification or to ceramic products before firing. (2) The address (i.e., physical Notification of Compliance Status that Glaze spray booth means a type of location) of the affected source; and you submitted, according to the equipment used for spraying glaze on (3) An identification of the relevant requirements in § 63.10(b)(2)(xiv). ceramic products. standard, or other requirement, that is (2) Records of all required High-volume, low-pressure (HVLP) the basis of the notification and source’s measurements needed to document spray equipment means a type of air compliance date. compliance with management practices atomized spray equipment that operates (b) You must submit a Notification of as required in § 63.10(b)(2)(vii), at low atomizing air pressure (0.1 to 10 Compliance Status required by § 63.9(h) including records of monitoring and pounds per square inch (psi) at the air no later than 120 calendar days after the inspection data required by §§ 63.11440. nozzle) and uses 15 to 30 cubic feet per applicable compliance date specified in (b) Your records must be in a form minute (cfm) of air to minimize the § 63.11437. In addition to the suitable and readily available for amount of overspray and bounce back. information required in § 63.9(h)(2), expeditious review, according to Kiln means equipment used for the your notification(s) must include each § 63.10(b)(1). initial curing or firing of glaze on compliance certification in paragraphs (c) As specified in § 63.10(b)(1), you ceramic ware. A kiln may operate (b)(1) through (3) of this section that must keep each record for 5 years continuously or by batch. applies to you and may be combined following the date of each occurrence, Nonatomizing glaze application with the Initial Notification required in measurement, maintenance, corrective technique means the application of paragraph (a) of this section. action, report, or record. glaze in the form of a liquid stream (1) For each kiln firing glazed ceramic (d) You must keep each record onsite without atomization. Such techniques ware, you must certify that you are for at least 2 years after the date of each include, but are not limited to, dipping, maintaining the peak temperature below occurrence, measurement, maintenance, centrifugal disc, waterfall, flow coaters, 1540°C (2800°F) and complying with corrective action, report, or record, curtain coaters, silk-screening, and any one of the management practices in according to § 63.10(b)(1). You may direct application by roller, brush, pad, paragraphs (b)(2)(i) and (ii) of this keep the records offsite for the or other means facilitating direct section: remaining 3 years. transfer of glaze. (i) Using natural gas, or equivalent Plant site means all contiguous or clean-burning fuel, as the kiln fuel; or Other Requirements and Information adjoining property that is under (ii) Using an electric-powered kiln. § 63.11443 What General Provisions apply common control, including properties (2) For atomized glaze spray booths, to this subpart? that are separated only by a road or you must certify that your facility’s Table 1 to this subpart shows which other public right-of-way. Common annual wet glaze usage is above or parts of the General Provisions in control includes properties that are below 227 Mg/yr (250 tpy). §§ 63.1 through 63.16 apply to you. owned, leased, or operated by the same (3) For atomized glaze spray booths entity, parent entity, subsidiary, or any located at a clay ceramics § 63.11444 What definitions apply to this combination thereof. manufacturing facility that uses more subpart? Waste minimization practices mean than 227 Mg/yr (250 tpy) of wet glaze(s), Terms used in this subpart are those routine procedures employed to you must certify that: defined in the Clean Air Act, in § 63.2, minimize material losses and prevent (i) You are operating and maintaining and in this section as follows: unnecessary waste generation, for an APCD in accordance with the Air pollution control device (APCD) example, minimizing glaze overspray equipment manufacturer’s means any equipment that reduces the emissions using HVLP spray equipment specifications, and you have conducted quantity of a pollutant that is emitted to (defined in this section) or similar spray an initial control device inspection for the air. Examples of APCD currently equipment; minimizing HAP emissions each wet control system and baghouse used on glaze spray booths include, but during cleanup of spray glazing

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equipment; operating and maintaining your State, local, or tribal agency, then § 63.11437, and the management spray glazing equipment according to that agency has the authority to practices in § 63.11438. manufacturer’s instructions; and implement and enforce this subpart. (2) Approval of a major change to a minimizing spills through careful You should contact your U.S. EPA test method under § 63.7(e)(2)(ii) and (f). handling of HAP-containing glaze Regional Office to find out if this A ‘‘major change to test method’’ is materials. subpart is delegated to your State, local, defined in § 63.90. Water curtain means an APCD that or tribal agency. (3) Approval of a major change to draws the exhaust stream through a (b) In delegating implementation and monitoring under § 63.8(f). A ‘‘major continuous curtain of moving water to enforcement authority of this subpart to scrub out suspended particulate. Also change to monitoring’’ is defined in a State, local, or tribal agency under 40 § 63.90. called a drip curtain or waterfall. CFR part 63, subpart E, the authorities (4) Approval of a major change to Water-wash system means an APCD contained in paragraph (c) of this recordkeeping/reporting under that uses a series of baffles to redirect section are retained by the § 63.10(f). A ‘‘major change to the upward exhaust stream through a Administrator of the U.S. EPA and are recordkeeping/reporting’’ is defined in water wash chamber with downward not transferred to the State, local, or § 63.90. water flow to scrub out suspended tribal agency. particulate. (c) The authorities that will not be §§ 63.11446–63.11447 [Reserved] delegated to State, local, or tribal § 63.11445 Who implements and enforces Tables to Subpart RRRRRR of Part 63 this subpart? agencies are listed in paragraphs (c)(1) (a) This subpart can be implemented through (4) of this section. As stated in § 63.11443, you must and enforced by the U.S. EPA or a (1) Approval of alternatives to the comply with the requirements of the delegated authority such as your State, applicability requirements in NESHAP General Provisions (40 CFR local, or tribal agency. If the U.S. EPA §§ 63.11435 and 63.11436, the part 63, subpart A) shown in the Administrator has delegated authority to compliance date requirements in following table:

TABLE 1 TO SUBPART RRRRRR OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART RRRRRR

Citation Subject

63.1(a)(1)–(a)(4), (a)(6), (a)(10)–(a)(12), (b)(1), (b)(3), (c)(1), (c)(2)1, Applicability. (c)(5), (e). 63.2...... Definitions. 63.3 ...... Units and Abbreviations. 63.4 ...... Prohibited Activities and Circumvention. 63.6(a), (b)(1)–(b)(5), (b)(7), (c)(1), (c)(2), (c)(5), (e)(1), (f), (g), (i), (j) ... Compliance with Standards and Maintenance Requirements. 63.8(a)(1), (a)(2), (b), (c)(1)(i)–(c)(1)(ii), (c)(2), (c)(3), (f) ...... Monitoring Requirements. 63.9(a), (b)(1), (b)(2), (b)(5), (c), (d), (h)(1)–(h)(3), (h)(5), (h)(6), (i), (j) .. Notification Requirements. 63.10(a), (b)(1), (b)(2)(vii), (b)(2)(xiv), (b)(3), (c), (c)(1), (f) ...... Recordkeeping and Reporting Requirements. 63.12 ...... State Authority and Delegations. 63.13 ...... Addresses. 63.14 ...... Incorporations by Reference. 63.15 ...... Availability of Information and Confidentiality. 63.16 ...... Performance Track Provisions. 1 Section 63.11435(b) of this subpart exempts area sources from the obligation to obtain title V operating permits.

4. Part 63 is amended by adding 63.11455 What are the continuous Subpart SSSSSS—National Emission subpart SSSSSS to read as follows: compliance requirements for new and Standards for Hazardous Air Pollutants existing sources? Subpart SSSSSS—National Emission for Glass Manufacturing Area Sources Standards for Hazardous Air Pollutants for Notifications and Records Applicability and Compliance Dates Glass Manufacturing Area Sources 63.11456 What are the notification Applicability and Compliance Dates requirements? § 63.11448 Am I subject to this subpart? Sec. 63.11457 What are the recordkeeping (a) You are subject to this subpart if 63.11448 Am I subject to this subpart? requirements? you own or operate a glass 63.11449 What parts of my plant does this manufacturing facility that is an area Other Requirements and Information subpart cover? source of hazardous air pollutant (HAP) 63.11450 What are my compliance dates? 63.11458 What General Provisions apply to emissions and meets the criteria this subpart? Standards, Compliance, and Monitoring specified in paragraphs (a)(1) through Requirements 63.11459 What definitions apply to this (3) of this section. subpart? (1) A glass manufacturing facility is a 63.11451 What are the standards for new 63.11460 Who implements and enforces and existing sources? plant site that manufactures flat glass, this subpart? 63.11452 What are the performance test glass containers, or pressed and blown 63.11461 [Reserved] requirements for new and existing glass by melting a mixture of raw sources? Tables to Subpart SSSSSS of Part 63 materials, as defined in § 63.11459, to 63.11453 What are the initial compliance produce molten glass and forming the demonstration requirements for new and Table 1 to Subpart SSSSSS of Part 63— existing sources? Emission Limits molten glass into sheets, containers, or 63.11454 What are the monitoring Table 2 to Subpart SSSSSS of Part 63— other shapes. requirements for new and existing Applicability of General Provisions to (2) An area source of HAP emissions sources? Subpart SSSSSS is any stationary source or group of

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stationary sources within a contiguous (2) If you start up your affected source if you satisfy the conditions described area under common control that does after the date of publication of the final in paragraphs (a)(2)(i) through (iii) of not have the potential to emit any single rule in the Federal Register, you must this section. HAP at a rate of 9.07 megagrams per comply with the applicable emission (i) You conducted a performance test year (Mg/yr) (10 tons per year (tpy)) or limits specified in § 63.11451 of this on the affected furnace within the past more and any combination of HAP at a subpart upon initial startup of your 5 years of the compliance date using the rate of 22.68 Mg/yr (25 tpy) or more. affected source. same test methods and procedures (3) Your glass manufacturing facility (c) If you own or operate a furnace specified in paragraph (b) of this produces glass that contains compounds that produces glass at an annual rate of section. of one or more glass manufacturing less than 45 Mg/yr (50 tpy), and you (ii) The performance test metal HAP, as defined in § 63.11459, as increase glass production for that demonstrated that the affected furnace raw materials in a glass manufacturing furnace to an annual rate of at least 45 met the applicable emission limits batch formulation. Mg/yr (50 tpy), and the furnace is specified in Table 1 to this subpart. (b) [Reserved] charged with compounds of one or more (iii) Either no process changes have glass manufacturing metal HAP, you been made since the test, or you can § 63.11449 What parts of my plant does must comply with the applicable demonstrate that the results of the this subpart cover? emission limits specified in § 63.11451 performance test, with or without (a) This subpart applies to each within 2 years of the date on which you adjustments, reliably demonstrate existing, new, or reconstructed affected increased the glass production rate for compliance with the applicable glass melting furnace that is located at the furnace to at least 45 Mg/yr (50 tpy). emission limit. a glass manufacturing facility and (d) If you own or operate a furnace (b) You must conduct each satisfies the requirements specified in that produces glass at an annual rate of performance test according to the paragraphs (a)(1) and (2) of this section. at least 45 Mg/yr (50 tpy) and is not requirements in § 63.7 and paragraphs (1) The furnace is charged with charged with glass manufacturing metal (b)(1) through (20) of this section. compounds of one or more glass HAP, and you begin production of a (1) Install and validate all monitoring manufacturing metal HAP as raw glass product that includes one or more equipment required by this subpart materials. glass manufacturing metal HAP as raw before conducting the performance test. (2) The furnace is used to produce materials, you must comply with the (2) Conduct the performance test glass at a rate of at least 45 Mg/yr (50 applicable emission limits specified in according to the requirements in § 63.7 tpy). § 63.11451 within 2 years of the date on and under the conditions specified in (b) An affected source is an existing which you introduced production of the this section. source if you commenced construction glass product that contains glass (3) You may not conduct performance or reconstruction of the affected source manufacturing metal HAP. tests during periods of startup, before September 20, 2007. (e) You must meet the notification shutdown, or malfunction, as specified (c) An affected source is a new (or requirements in § 63.11456 according to in § 63.7(e)(1). reconstructed) source if you commenced the schedule in § 63.11456 and in 40 (4) Conduct the test while the source construction (or reconstruction) of the CFR part 63, subpart A. Some of the is operating at the maximum production affected source on or after September notifications must be submitted before rate. 20, 2007. you are required to comply with (5) Conduct at least three separate test emission limits specified in this runs with a minimum duration of 1 § 63.11450 What are my compliance hour for each test run, as specified in dates? subpart. § 63.7(e)(3). (a) If you have an existing affected Standards, Compliance, and (6) Record the test date. source, you must comply with the Monitoring Requirements (7) Identify the emission source applicable emission limits specified in § 63.11451 What are the standards for new tested. § 63.11451 of this subpart no later than and existing sources? (8) Collect and record the emission 2 years after the date of publication of If you are an owner or operator of an test data listed in this section for each the final rule in the Federal Register. As affected furnace, as defined in run of the performance test. specified in section 112(i)(3)(B) of the § 63.11449(a), you must meet the (9) Locate all sampling sites at the Clean Air Act and in § 63.6(i)(4)(i)(A), applicable emission limits specified in outlet of the control device or at the you may request that the Administrator Table 1 to this subpart. stack prior to any releases to the or delegated authority grant an atmosphere. extension allowing up to 1 additional § 63.11452 What are the performance test (10) Select the locations of sampling year to comply with the applicable requirements for new and existing sources? ports and the number of traverse points emission limits if such additional (a) If you own or operate an affected using Method 1 or 1A of 40 CFR part 60, period is necessary for the installation furnace that is subject to an emission appendix A–1. of emission controls. limit specified in Table 1 to this (11) Measure the gas velocity and (b) If you have a new or reconstructed subpart, you must conduct a volumetric flow rate using Method 2, affected source, you must comply with performance test according to 2A, 2C, 2F, or 2G of 40 CFR part 60, this subpart according to paragraphs paragraphs (a)(1) and (2) and paragraph appendices A–1 and A–2, during each (b)(1) and (2) of this section. (b) of this section. test run. (1) If you start up your affected source (1) For each affected furnace, you (12) Conduct gas molecular weight on or before the date of publication of must conduct a performance test within analysis using Methods 3, 3A, or 3B of the final rule in the Federal Register, 180 days after your compliance date and 40 CFR part 60, appendix A–2, or ASME you must comply with the applicable report the results in your Notification of PTC 19.10–1981—Part 10, during each emission limits specified in § 63.11451 Compliance Status, except as specified test run. of this subpart no later than the date of in paragraph (a)(2) of this section. (13) Measure gas moisture content publication of the final rule in the (2) You are not required to conduct a using Method 4 of 40 CFR part 60, Federal Register. performance test on the affected furnace appendix A–3, during each test run.

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(14) Measure the particulate matter (b) For each existing affected furnace (ii) The bag leak detection system (PM) mass emission rate at the outlet of that is subject to the emission limits sensor must provide output of relative the control device or at the stack using specified in Table 1 to this subpart, you PM loadings. The owner or operator Method 5 or 17 of 40 CFR part 60, must demonstrate initial compliance shall continuously record the output appendices A–3 or A–6, for each test according to the requirements in from the bag leak detection system using run. paragraphs (b)(1) through (4) of this electronic or other means (e.g., using a (15) Calculate the PM mass emission section. strip chart recorder or a data logger). rate in the exhaust stream for each test (1) For each fabric filter that is used (iii) The bag leak detection system run. to meet the emission limits specified in must be equipped with an alarm system (16) Measure and record the glass Table 1 to this subpart, you must that will sound when the system detects production rate (kilograms (tons) per visually inspect the system ductwork an increase in relative particulate hour of product) for each test run. and fabric filter unit for leaks. You must loading over the alarm set point (17) To meet the PM emission limit, also inspect the inside of each fabric established according to paragraph calculate the production-based PM mass filter for structural integrity and fabric (c)(1)(iv) of this section, and the alarm emission rate (g/kg (lbs/ton)) for each filter condition. You must record the must be located such that it can be test run using Equation 1. results of the inspection and any heard by the appropriate plant maintenance action as required in personnel. ER § 63.11457. (iv) In the initial adjustment of the bag MP = (Equation 1) (2) For each electrostatic precipitator P leak detection system, you must (ESP) that is used to meet the emission establish, at a minimum, the baseline Where: limits specified in Table 1 to this output by adjusting the sensitivity MP = production-bass PM mass emission subpart, you must verify the proper (range) and the averaging period of the rate, grams of PM per kilogram (pounds functioning of the electronic controls for of PM per ton) of glass produced. device, the alarm set points, and the ER = PM mass emission rate measured using corona power and rapper operation, that alarm delay time. Methods 5 or 17 during each the corona wires are energized, and that (v) Following initial adjustment, you performance test run, grams (pounds) per adequate air pressure is present on the shall not adjust the averaging period, hour. rapper manifold. You must also visually alarm set point, or alarm delay time P = average glass production rate for the inspect the system ductwork and ESP without approval from the performance test, kilograms (tons) of housing unit and hopper for leaks and Administrator or delegated authority glass produced per hour. inspect the interior of the ESP to except as provided in paragraph (18) Calculate the 3-hour block determine the condition and integrity of (c)(1)(vi) of this section. average production-based PM mass corona wires, collection plates, hopper, (vi) Once per quarter, you may adjust emission rate as the average of the and air diffuser plates. the sensitivity of the bag leak detection production-based PM mass emission (3) You must conduct each inspection system to account for seasonal effects, rates for each test run. specified in paragraphs (b)(1) and (2) of including temperature and humidity, (19) To meet the metal HAP emission this section no later than 60 days after according to the procedures identified limit, calculate the production-based your applicable compliance date in the site-specific monitoring plan metal HAP mass emission rate (g/kg specified in § 63.11450, except as required by paragraph (c)(2) of this (lbs/ton)) for each test run using specified in paragraph (b)(3)(i) and (ii) section. Equation 2. of this section. (vii) You must install the bag leak (i) An initial inspection of the internal detection sensor downstream of the ERM components of a fabric filter is not fabric filter. MPM = (Equation 2)required if an inspection has been (viii) Where multiple detectors are P performed within the past 12 months. required, the system’s instrumentation Where: (ii) An initial inspection of the and alarm may be shared among MPM = production-bass metal HAP mass internal components of an ESP is not detectors. emission rate, grams of metal HAP per required if an inspection has been (2) You must develop and submit to kilogram (pounds of metal HAP per ton) performed within the past 24 months. the Administrator or delegated authority of glass produced. (4) You must satisfy the applicable for approval a site-specific monitoring ERM = Metal HAP mass emission rate measured using Method 29 of 40 CFR requirements for performance tests plan for each bag leak detection system. part 60, appendix A–8 during each specified in § 63.11452. You must operate and maintain the bag performance test run, grams (pounds) per (c) For each new or reconstructed leak detection system according to the hour. affected furnace that is subject to the site-specific monitoring plan at all P = average glass production rate for the emission limits specified in Table 1 to times. Each monitoring plan must performance test, kilograms (tons) of this subpart and is controlled with a describe the items in paragraphs (c)(2)(i) glass produced per hour. fabric filter, you must install, operate, through (vi) of this section. (20) Calculate the 3-hour block and maintain a bag leak detection (i) Installation of the bag leak average production-based metal HAP system according to paragraphs (c)(1) detection system; mass emission rate as the average of the through (3) of this section. (ii) Initial and periodic adjustment of production-based metal HAP mass (1) Each bag leak detection system the bag leak detection system, including emission rates for each test run. must meet the specifications and how the alarm set-point will be requirements in paragraphs (c)(1)(i) established; § 63.11453 What are the initial compliance through (viii) of this section. (iii) Operation of the bag leak demonstration requirements for new and (i) The bag leak detection system must detection system, including quality existing sources? be certified by the manufacturer to be assurance procedures; (a) If you own or operate an affected capable of detecting PM emissions at (iv) How the bag leak detection source, you must submit a Notification concentrations of 1 milligram per dry system will be maintained, including a of Compliance Status in accordance standard cubic meter (0.00044 grains routine maintenance schedule and spare with § 63.9(h) and 63.11456(b). per actual cubic foot) or less. parts inventory list;

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(v) How the bag leak detection system to a value that is at least 20 percent (e) For each new or reconstructed output will be recorded and stored; and greater than the highest value that you affected furnace that is subject to the (vi) Corrective action procedures as expect your CPMS to measure. emission limits specified in Table 1 to specified in paragraph (c)(3) of this (3) The signal conditioner, wiring, this subpart and is controlled a device section. In approving the site-specific power supply, and data acquisition and other than a fabric filter or an ESP, you monitoring plan, the Administrator or recording system of your CPMS must be must prepare and submit a monitoring delegated authority may allow owners compatible with the output signal of the plan to EPA or the delegated authority and operators more than 3 hours to sensors used in your CPMS. for approval. Each plan must contain alleviate a specific condition that causes (4) The data acquisition and recording the information in paragraphs (e)(1) an alarm if the owner or operator system of your CPMS must be able to through (5) of this section. identifies in the monitoring plan this record values over the entire range (1) A description of the device; specific condition as one that could lead specified in paragraph (d)(2) of this (2) Test results collected in to an alarm, adequately explains why it section. accordance with § 63.11452 verifying is not feasible to alleviate this condition (5) The data recording system the performance of the device for within 3 hours of the time the alarm associated with your CPMS must have reducing PM to the levels required by occurs, and demonstrates that the a resolution of one-half of the required this subpart; requested time will ensure alleviation of overall accuracy of your CPMS, as (3) Operation and maintenance plan this condition as expeditiously as specified in paragraph (d)(1) of this for the control device (including a practicable. section, or better. preventative maintenance schedule (3) For each bag leak detection (6) Your CPMS must be equipped consistent with the manufacturer’s system, you must initiate procedures to with an alarm system that will sound instructions for routine and long-term determine the cause of every alarm when the system detects a decrease in maintenance) and continuous within 1 hour of the alarm. Except as secondary voltage or secondary monitoring system; provided in paragraph (c)(2)(vi) of this electrical current below the alarm set (4) A list of operating parameters that section, you must alleviate the cause of point established according to will be monitored to maintain the alarm within 3 hours of the alarm by paragraph (d)(7) of this section, and the continuous compliance with the taking whatever corrective action(s) are alarm must be located such that it can applicable emission limits; and necessary. Corrective actions may be heard by the appropriate plant (5) Operating parameter limits based include, but are not limited to the personnel. on monitoring data collected during the following: (7) In the initial adjustment of the performance test. (i) Inspecting the fabric filter for air CPMS, you must establish, at a leaks, torn or broken bags or filter § 63.11454 What are the monitoring minimum, the baseline output by requirements for new and existing sources? media, or any other condition that may adjusting the sensitivity (range) and the (a) For each monitoring system cause an increase in PM emissions; averaging period of the device, the (ii) Sealing off defective bags or filter required by this subpart, you must alarm set points, and the alarm delay install, calibrate, operate, and maintain media; time. (iii) Replacing defective bags or filter the monitoring system according to the (8) You must install each sensor of the media or otherwise repairing the control manufacturer’s specifications and the CPMS in a location that provides device; requirements specified in paragraphs (iv) Sealing off a defective fabric filter representative measurement of the (a)(1) through (6) of this section. compartment; appropriate parameter over all operating (1) You must install each sensor of (v) Cleaning the bag leak detection conditions, taking into account the your monitoring system in a location system probe or otherwise repairing the manufacturer’s guidelines. that provides representative bag leak detection system; or (9) You must perform an initial measurement of the appropriate (vi) Shutting down the process calibration of your CPMS based on the parameter over all operating conditions, producing the PM emissions. procedures specified in the taking into account the manufacturer’s (d) For each new or reconstructed manufacturer’s owner’s manual. guidelines. affected furnace that is subject to the (10) Your CPMS must be designed to (2) You must perform an initial emission limits specified in Table 1 to complete a minimum of one cycle of calibration of your monitoring system this subpart and is controlled with an operation for each successive 15-minute based on the manufacturer’s ESP, you must install, operate, and period. To have a valid hour of data, recommendations. maintain according to the you must have at least three of four (3) You must use a monitoring system manufacturer’s specifications, one or equally-spaced data values (or at least that is designed to complete a minimum more continuous parameter monitoring 75 percent of the total number of values of one cycle of operation for each systems (CPMS) for measuring and if you collect more than four data values successive 15-minute period. recording the secondary voltage and per hour) for that hour (not including (4) For each existing affected furnace, secondary electrical current to each startup, shutdown, malfunction, or out you must record the value of the field of the ESP according to paragraphs of control periods). monitored parameter at least every 8 (d)(1) through (13) of this section. (11) You must record valid data from hours. The value can be recorded (1) The CPMS must have an accuracy at least 90 percent of the hours during electronically or manually. of 1 percent of the secondary voltage which the affected source or process (5) You must record the results of and secondary electrical current, or operates. each inspection, calibration, monitoring better. (12) You must record the results of system maintenance, and corrective (2) Your CPMS must be capable of each inspection, calibration, initial action taken to return the monitoring measuring the secondary voltage and validation, and accuracy audit. system to normal operation. secondary electrical current over a range (13) At all times, you must maintain (6) At all times, you must maintain that extends from a value that is at least your CPMS including, but not limited your monitoring system including, but 20 percent less than the lowest value to, maintaining necessary parts for not limited to, maintaining necessary that you expect your CPMS to measure, routine repairs of the CPMS. parts for routine repairs of the system.

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(b) For each existing furnace that (iv) Frequency that the operating monitor the parameter specified in subject to the emission limits specified parameter values will be measured and § 63.11454(c) in accordance with the in Table 1 to this subpart and is recorded. requirements of § 63.11454(a) or as controlled with an ESP, you must meet (v) Procedures for inspecting the specified in your approved alternative the requirements specified in condition and operation of the control monitoring plan. paragraphs (b)(1) or (2) of this section. device and monitoring system. (3) For each affected furnace that is (1) You must monitor the secondary (g) If you wish to use a monitoring controlled with a device other than a voltage and secondary electrical current method other than those specified in fabric filter or ESP, you must comply to each field of the ESP according to the paragraphs (b)(1) or (c)(1) of this section, with the requirements of your approved requirements of this section, or you must meet the requirements in alternative monitoring plan, as required (2) You must submit a request for § 63.8(f) and paragraph (g)(1) of this in § 63.11454(g). alternative monitoring, as described in section. (4) For each monitoring system that is paragraph (g) of this section. (1) Submit a request for approval of required under this subpart, you must (c) For each existing furnace that is alternative monitoring methods to the keep the records specified in § 63.11457. subject to the emission limits specified Administrator no later than the in Table 1 to this subpart and is submittal date for the Notification of (d) Following the initial inspections, controlled with a fabric filter, you must Compliance Status, as specified in you must perform periodic inspections meet the requirements specified in § 63.11456(b). The request must contain and maintenance of each affected paragraphs (c)(1) or (2) of this section. the information specified in paragraphs furnace control device according to the (1) You must monitor the inlet (g)(1)(i) through (v) of this section. requirements in paragraphs (d)(1) temperature to the fabric filter according (i) Type of monitoring device or through (4) of this section. to the requirements of this section, or method that will be used, including the (1) For each fabric filter, you must (2) You must submit a request for sensor type, location, inspection conduct inspections at least every 12 alternative monitoring, as described in procedures, QA/QC measures, and data months according to paragraphs (d)(1)(i) paragraph (g) of this section. recording device. through (iii) of this section. (d) For each new or reconstructed (ii) Operating parameters that will be (i) You must inspect the ductwork furnace that is subject to the emission monitored. and fabric filter unit for leakage. limits specified in Table 1 to this (iii) Frequency that the operating (ii) You must inspect the interior of subpart and is controlled with an ESP, parameter values will be measured and the fabric filter for structural integrity you must monitor the voltage and recorded. and to determine the condition of the electrical current to each field of the (v) Procedures for inspecting the fabric filter. ESP on a continuous basis using one or condition and operation of the (iii) If an initial inspection is not more CPMS according to the monitoring system. requirements for CPMS specified in required, as specified in (vi) Explanation for how the § 63.11453(b)(3)(i), the first inspection § 63.11453(d). alternative monitoring method will (e) For each new or reconstructed must not be more than 12 months from provide assurance that the emission the last inspection. furnace that is subject to the emission control device is operating properly. limits specified in Table 1 to this (2) [Reserved] (2) For each ESP, you must conduct subpart and is controlled with a fabric inspections according to the filter, you must install and operate a bag § 63.11455 What are the continuous requirements in paragraphs (d)(2)(i) leak detection system according to the compliance requirements for new and through (iii) of this section. requirements for CPMS specified in existing sources? (i) You must conduct visual § 63.11453(c). (a) You must be in compliance with inspections of the system ductwork, (f) For each new, reconstructed, or the applicable emission limits and work housing unit, and hopper for leaks at existing furnace that is subject to the practices in this subpart at all times, least every 12 months. emission limits specified in Table 1 to except during periods of startup, (ii) You must conduct inspections of this subpart and is equipped with a shutdown, and malfunction. the interior of the ESP to determine the control device other than an ESP or (b) You must always operate and condition and integrity of corona wires, fabric filter, you must meet the maintain your affected source, including collection plates, plate rappers, hopper, requirements in § 63.8(f) and paragraph air pollution control and monitoring and air diffuser plates every 24 months. equipment, according to the provisions (f)(1) of this section. (iii) If an initial inspection is not (1) Submit a request for approval of in § 63.6(e)(1)(i). required, as specified in alternative monitoring methods to the (c) For each affected furnace that is § 63.11453(b)(3)(ii), the first inspection Administrator no later than the subject to the emission limits specified must not be more than 24 months from submittal date for the Notification of in Table 1 to this subpart, you must the last inspection. Compliance Status, as specified in monitor the performance of the furnace § 63.11456(b). The request must contain emission control device according to the (3) You must record the results of the information specified in paragraphs requirements in §§ 63.6(e)(1) and 63.8(c) each periodic inspection specified in (f)(1)(i) through (v) of this section. and paragraphs (c)(1) through (4) of this this section in a logbook (written or (i) Description of the alternative add- section. electronic format), as specified in on air pollution control device (APCD). (1) For each affected furnace that is § 63.11457. (ii) Type of monitoring device or controlled with an ESP, you must (4) If the results of a required method that will be used, including the monitor the parameters specified in inspection indicate a problem with the sensor type, location, inspection § 63.11454(b) in accordance with the operation of the emission control procedures, quality assurance and requirements of § 63.11454(a) or as system, you must take immediate quality control (QA/QC) measures, and specified in your approved alternative corrective action to return the control data recording device. monitoring plan. device to normal operation according to (iii) Operating parameters that will be (2) For each affected furnace that is the equipment manufacturer’s monitored. controlled with a fabric filter, you must specifications or instructions.

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Notifications and Records (4) The records required to show onsite and make the logbook available to continuous compliance with each the permitting authority upon request. § 63.11456 What are the notification emission limit that applies to you, as (d) As specified in § 63.10(b)(1), you requirements? specified in § 63.11455. must keep each record for a minimum (a) If you own or operate an affected (5) For each affected source, records of 5 years following the date of each furnace, as defined in § 63.11449(a), you of production rate on a process occurrence, measurement, maintenance, must submit an Initial Notification in throughput basis (either feed rate to the corrective action, report, or record. accordance with § 63.9(b) and process unit or discharge rate from the You must keep each record onsite for paragraphs (a)(1) through (3) of this process unit). at least 2 years after the date of each section by the dates specified. (i) The production data must include occurrence, measurement, maintenance, (1) As specified in § 63.9(b)(2) and (3), the amount (weight or weight percent) corrective action, report, or record, if you start up your affected source of each ingredient in the batch according to § 63.10(b)(1). You may before the date of publication of the formulation, including all glass keep the records offsite for the final rule in the Federal Register, you manufacturing metal HAP compounds. remaining 3 years. must submit an Initial Notification not (ii) [Reserved] later than 120 calendar days after the (6) Records of maintenance activities Other Requirements and Information date of publication of the final rule in and inspections performed on control § 63.11458 What General Provisions apply the Federal Register. devices as specified in §§ 63.11453(b) to this subpart? (2) The Initial Notification must and 63.11455(d), according to You must satisfy the requirements of include the information specified in paragraphs (a)(6)(i) through (v) of this the General Provisions in 40 CFR part § 63.9(b)(2)(i) to (iv). section. 63, subpart A, as specified in Table 2 to (3) As specified in § 63.9(b)(3), if you (i) The date, place, and time of this subpart. start up your new or reconstructed inspections of control device ductwork, affected source on or after the date of interior, and operation. § 63.11459 What definitions apply to this publication of the final rule in the (ii) Person conducting the inspection. subpart? Federal Register, you must submit an (iii) Technique or method used to Terms used in this subpart are Initial Notification not later than 120 conduct the inspection. defined in the Clean Air Act, in § 63.2, calendar days after you become subject (iv) Control device operating and in this section as follows: to this subpart. conditions during the time of the Air pollution control device (APCD) (b) You must submit a Notification of inspection. means any equipment that reduces the Compliance Status in accordance with (v) Results of the inspection and quantity of a pollutant that is emitted to § 63.9(h) and the requirements in description of any corrective action the air. paragraphs (b)(1) and (2) of this section. taken. Cullet means recycled glass that is (1) If you own or operate an affected (7) Records of all required monitoring mixed with raw materials and charged furnace and are required to conduct a data and supporting information to a glass melting furnace to produce performance test, you must submit a including all calibration and glass. Notification of Compliance Status, maintenance records. Electrostatic precipitator (ESP) means including the performance test results, (8) For each bag leak detection an APCD that removes PM from an before the close of business on the 60th system, the records specified in exhaust gas stream by applying an calendar day following the completion paragraphs (a)(8)(i) through (iii) of this electrical charge to particles in the gas of the performance test, according to section. stream and collecting the charged § 60.8 or § 63.10(d)(2). (i) Records of the bag leak detection particles on plates carrying the opposite (2) If you own or operate an affected system output; electrical charge. furnace and satisfy the conditions (ii) Records of bag leak detection Fabric filter means an APCD used to specified in § 63.11452(a)(2) and are not system adjustments, including the date capture PM by filtering a gas stream required to conduct a performance test, and time of the adjustment, the initial through filter media. you submit a Notification of Compliance bag leak detection system settings, and Glass manufacturing metal HAP Status, including the results of the the final bag leak detection system means an oxide or other compound of previous performance test, before the settings; and any of the following metals included in close of business on the compliance (iii) The date and time of all bag leak the list of urban HAP for the Integrated date specified in § 63.11450, according detection system alarms, the time that Urban Air Toxics Strategy and for which to § 63.10(d)(2). procedures to determine the cause of the Glass Manufacturing was listed as an alarm were initiated, the cause of the area source category: arsenic, cadmium, § 63.11457 What are the recordkeeping alarm, an explanation of the actions chromium, lead, manganese, and nickel. requirements? taken, the date and time the cause of the Glass melting furnace means a unit (a) You must keep the records alarm was alleviated, and whether the comprising a refractory-lined vessel in specified in paragraphs (a)(1) through alarm was alleviated within 3 hours of which raw materials are charged, melted (9) of this section. the alarm. at high temperature, refined, and (1) A copy of any Initial Notification (9) Records of any approved conditioned to produce molten glass. and Notification of Compliance Status alternative monitoring method(s) or test The unit includes foundations, that you submitted and all procedure(s). superstructure and retaining walls, raw documentation supporting those (b) Your records must be in a form material charging system, heat notifications, according to the suitable and readily available for exchangers, melter cooling system, requirements in § 63.10(b)(2)(xiv). expeditious review, according to exhaust system, refractory brick work, (2) The records in § 63.6(e)(3)(iii) § 63.10(b)(1). fuel supply and electrical boosting through (v) related to startup, shutdown, (c) You must record the results of equipment, integral control systems and and malfunction. each inspection and maintenance action instrumentation, and appendages for (3) The records specified in in a logbook (written or electronic conditioning and transferring molten § 63.10(b)(2) and (c)(1) through (13). format). You must keep the logbook glass to forming apparatuses.

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Particulate matter (PM) means, for antimonate; metal ores, such as section are retained by the purposes of this subpart, emissions of chromite and pyrolusite; and other Administrator of the U.S. EPA and are PM that serve as a measure of total substances that are intentionally added not transferred to the State, local, or particulate emissions, as measured by to a glass manufacturing batch and tribal agency. Methods 5 or 17 (40 CFR part 60, melted in a glass melting furnace to (c) The authorities that will not be appendices A–3 and A–6), and as a produce glass. Metals that are naturally- delegated to State, local, or tribal surrogate for glass manufacturing metal occurring trace constituents or agencies are listed in paragraphs (c)(1) HAP compounds contained in the PM contaminants of other substances are through (3) of this section. including, but not limited to, arsenic, not considered to be raw materials. (1) Approval of alternatives to the cadmium, chromium, lead, manganese, § 63.11460 Who implements and enforces applicability requirements in and nickel. this subpart? §§ 63.11448 and 63.11449, the Plant site means all contiguous or (a) This subpart can be implemented compliance date requirements in adjoining property that is under and enforced by us, the U.S. EPA, or a § 63.11450, and the emission limits common control, including properties delegated authority such as your State, specified in § 63.11451. that are separated only by a road or local, or tribal agency. If the U.S. EPA (2) Approval of major alternatives to other public right-of-way. Common Administrator has delegated authority to monitoring under § 63.8(f) and as control includes properties that are your State, local, or tribal agency, then defined in § 63.90. owned, leased, or operated by the same that agency has the authority to (3) Approval of major alternatives to entity, parent entity, subsidiary, or any implement and enforce this subpart. recordkeeping under § 63.10(f) and as combination thereof. You should contact your U.S. EPA defined in § 63.90. Raw material means minerals, such as Regional Office to find out if this silica sand, limestone, and dolomite; subpart is delegated to your State, local, § 63.11461 [Reserved] inorganic chemical compounds, such as or tribal agency. Tables to Subpart SSSSSS of Part 63 soda ash (sodium carbonate), salt cake (b) In delegating implementation and (sodium sulfate), and potash (potassium enforcement authority of this subpart to As required in § 63.11451, you must carbonate); metal oxides and other a State, local, or tribal agency under 40 comply with each emission limit that metal-based compounds, such as lead CFR part 63, subpart E, the authorities applies to you according to the oxide, chromium oxide, and sodium contained in paragraph (c) of this following table:

TABLE 1 TO SUBPART SSSSSS OF PART 63.—EMISSION LIMITS

For each . . . You must meet the following emission limits . . .

1. New or existing glass melting furnace that produces glass at an an- a. The 3-hour block average production-based PM mass emission rate nual rate of at least 45 Mg/yr (50 tpy) AND is charged with com- must not exceed 0.2 pounds per ton (lb/ton) of glass produced; OR pounds of arsenic, cadmium, chromium, manganese, lead, or nickel b. The 3-hour block average production-based metal HAP mass emis- as raw materials. sion rate must not exceed 0.02 lb/ton of glass produced.

As stated in § 63.11458, you must part 63, subpart A), as shown in the comply with the requirements of the following table: NESHAP General Provisions (40 CFR

TABLE 2 TO SUBPART SSSSSS OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART SSSSSS

Citation Subject

§ 63.1(a), (b), (c)(1), (c)(2), (c)(5), (e) ...... Applicability. § 63.2 ...... Definitions. § 63.3 ...... Units and Abbreviations. § 63.4 ...... Prohibited Activities. § 63.5 ...... Construction/Reconstruction. § 63.6(a), (b)(1)–(b)(5), (b)(7), (c)(1), (c)(2), (c)(5), (e)–(j) ...... Compliance with Standards and Maintenance Requirements. § 63.7 ...... Performance Testing Requirements. § 63.8(a)(1), (a)(2), (b), (c)(1)–(c)(4), (c)(7)(i)(B), (c)(7)(ii), (c)(8), (d), Monitoring Requirements. (e)(1), (e)(4), (f). § 63.9(a), (b)(1)(i)–(b)(2)(v), (b)(5), (c), (d), (h)–(j) ...... Notification Requirements. § 63.10(a), (b)(1), (b)(2)(i)–(b)(2)(xii) ...... Recordkeeping and Reporting Requirements. § 63.10(b)(2)(xiv), (c), (f) ...... Documentation for Initial Notification and Notification of Compliance Status. § 63.12 ...... State Authority and Delegations. § 63.13 ...... Addresses. § 63.14 ...... Incorporation by Reference. § 63.15 ...... Availability of Information. § 63.16 ...... Performance Track Provisions.

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5. Part 63 is amended by adding § 63.11463 What parts of my plant does (b) If you own or operate an existing subpart TTTTTT to read as follows: this subpart cover? affected source, you are not required to Subpart TTTTTT—National Emission (a) This subpart applies to any conduct a performance test if a prior Standards for Hazardous Air Pollutants for existing, new, or reconstructed affected performance test was conducted within Secondary Nonferrous Metals Processing source located at a secondary the past 5 years of the compliance date Area Sources nonferrous metals processing facility. using the same methods specified in (b) The affected source includes all paragraph (c) of this section and you Applicability and Compliance Dates crushing and screening operations at a meet either of the following two Sec. secondary zinc processing facility and conditions: 63.11462 Am I subject to this subpart? all furnace melting operations located at (1) No process changes have been 63.11463 What parts of my plant does this any secondary nonferrous metals made since the test; or subpart cover? processing facilities. (2) You demonstrate that the results of 63.11464 What are my compliance dates? (c) An affected source is existing if the performance test, with or without Standards, Compliance, and Monitoring you commenced construction or adjustments, reliably demonstrates Requirements reconstruction of the affected source compliance despite process changes. 63.11465 What are the standards for new before September 20, 2007. (c) Test methods. You must conduct and existing sources? (d) An affected source is new if you each performance test according to the 63.11466 What are the performance test commenced construction or requirements in § 63.7 and paragraphs requirements for new and existing reconstruction of the affected source on (c)(1) and (2) of this section. sources? or after September 20, 2007. (1) Determine the concentration of PM 63.11467 What are the initial compliance according to the following test methods demonstration requirements for new and § 63.11464 What are my compliance in 40 CFR part 60, appendices: dates? existing sources? (i) Method 1 or 1A (Appendix A–1) to 63.11468 What are the monitoring (a) If you have an existing affected select sampling port locations and the requirements for new and existing source, you must comply with the sources? number of traverse points in each stack standards no later than the date of or duct. Sampling sites must be located 63.11469 What are the notification publication of the final rule in the requirements? at the outlet of the control device and 63.11470 What are the recordkeeping Federal Register. prior to any releases to the atmosphere. requirements? (b) If you have a new or reconstructed (ii) Method 2, 2A, 2C, 2D, 2F, or 2G affected source, you must comply with Other Requirements and Information (Appendices A–1 and A–2) to determine this subpart according to paragraphs the volumetric flow rate of the stack gas. 63.11471 What General Provisions apply to (b)(1) and (b)(2) of this section. (iii) Method 3, 3A, 3B(Appendix A– this subpart? (1) If you start up your affected source 2), or ANSI/ASME PTC 19.10–1981, 63.11472 What definitions apply to this on or before the date of publication of ‘‘Flue and Exhaust Gas Analyses subpart? the final rule in the Federal Register, 63.11473 Who implements and enforces (incorporated by reference—see § 63.14) you must comply with this subpart no to determine the dry molecular weight this subpart? later than the date of publication of the 63.11474 [Reserved] of the stack gas. final rule in the Federal Register. (iv) Method 4 (Appendix A–3) to Tables to Subpart TTTTTT of Part 63 (2) If you start up your affected source determine the moisture content of the Table 1 to Subpart TTTTTT of Part 63— after the date of publication of the final stack gas. Applicability of General Provisions to rule in the Federal Register, you must (v) Method 5 or 5D (Appendix A–3) Subpart TTTTTT comply with this subpart upon initial to determine the concentration of startup of your affected source. Subpart TTTTTT—National Emission particulate matter (front half filterable Standards for Hazardous Air Pollutants Standards, Compliance, and catch only). Three valid test runs are for Secondary Nonferrous Metals Monitoring Requirements needed to comprise a performance test. Processing Area Sources (2) During the test, you must operate § 63.11465 What are the standards for new each emissions source within ±10 Applicability and Compliance Dates and existing sources? percent of its normal process rate. You (a) You must route the emissions from must monitor and record the process § 63.11462 Am I subject to this subpart? each existing affected source through a rate during the test. fabric filter or baghouse that achieves a (a) You are subject to this subpart if § 63.11467 What are the initial compliance you own or operate a secondary PM control efficiency of at least 99.0 percent. demonstration requirements for new and nonferrous metals processing facility (as existing sources? defined in § 63.11472) that is an area (b) You must route the emissions from each new affected source through a (a) You must demonstrate initial source of hazardous air pollutant (HAP) compliance with the applicable emissions. fabric filter or baghouse that achieves a PM control efficiency of at least 99.5 standards in § 63.11465 by submitting a (b) If you are an owner or operator of percent. Notification of Compliance Status in an area source subject to this subpart, accordance with § 63.11469(b). you are exempt from the obligation to § 63.11466 What are the performance test (b) You must conduct the inspection obtain a permit under 40 CFR part 70 or requirements for new and existing sources? specified in paragraph (c) of this section 71, provided you are not required to (a) Except as specified in paragraph and include the results of the inspection obtain a permit under 40 CFR 70.3(a) or (b) of this section, if you own or operate in the Notification of Compliance 71.3(a) for a reason other than your an existing or new affected source, you Status. status as an area source under this must conduct a performance test for (c) For each existing and new affected subpart. Notwithstanding the previous each affected source within 180 days of source, you must conduct an initial sentence, you must continue to comply your compliance date and report the inspection of each baghouse. You must with the provisions of this subpart results in your notification of visually inspect the system ductwork applicable to area sources. compliance status. and baghouse unit for leaks. Except as

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specified in paragraph (e) of this (c) For each new affected source, you describe the items in paragraphs (c)(2)(i) section, you must also inspect the inside must install, operate, and maintain a bag through (vi) of this section. of each baghouse for structural integrity leak detection system according to (i) Installation of the bag leak and fabric filter condition. You must paragraphs (c)(1) through (3) of this detection system; record the results of the inspection and section. (ii) Initial and periodic adjustment of any maintenance action as required in (1) Each bag leak detection system the bag leak detection system, including § 63.11470. must meet the specifications and how the alarm set-point will be (d) For each installed baghouse that is requirements in paragraphs (c)(1)(i) established; in operation during the 60 days after the through (viii) of this section. (iii) Operation of the bag leak applicable compliance date, you must (i) The bag leak detection system must detection system, including quality conduct the inspection specified in be certified by the manufacturer to be assurance procedures; paragraph (c) of this section no later capable of detecting PM emissions at (iv) How the bag leak detection than 60 days after your applicable concentrations of 1 milligram per dry system will be maintained, including a compliance date. For an installed standard cubic meter (0.00044 grains routine maintenance schedule and spare baghouse that is not in operation during per actual cubic foot) or less. parts inventory list; the 60 days after the applicable (ii) The bag leak detection system (v) How the bag leak detection system compliance date, you must conduct an sensor must provide output of relative output will be recorded and stored; and initial inspection prior to startup of the PM loadings. The owner or operator (vi) Corrective action procedures as baghouse. shall continuously record the output specified in paragraph (c)(3) of this (e) An initial inspection of the from the bag leak detection system using section. In approving the site-specific internal components of a baghouse is electronic or other means (e.g., using a monitoring plan, the Administrator or not required if an inspection has been strip chart recorder or a data logger). delegated authority may allow owners performed within the past 12 months. (iii) The bag leak detection system and operators more than 3 hours to (f) You must submit the Notification must be equipped with an alarm system alleviate a specific condition that causes of Compliance Status within 120 that will sound when the system detects an alarm if the owner or operator calendar days after the applicable an increase in relative particulate identifies in the monitoring plan this compliance date specified in § 63.11464. loading over the alarm set point specific condition as one that could lead established according to paragraph to an alarm, adequately explains why it § 63.11468 What are the monitoring (c)(1)(iv) of this section, and the alarm is not feasible to alleviate this condition requirements for new and existing sources? must be located such that it can be within 3 hours of the time the alarm (a) For an existing affected source, heard by the appropriate plant occurs, and demonstrates that the you must demonstrate compliance by personnel. requested time will ensure alleviation of conducting the monitoring activities in (iv) In the initial adjustment of the bag this condition as expeditiously as paragraph (a)(1) or (a)(2) of this section: leak detection system, you must practicable. (1) Periodic inspections/maintenance. establish, at a minimum, the baseline (3) For each bag leak detection You must perform periodic inspections output by adjusting the sensitivity system, you must initiate procedures to and maintenance of each baghouse (range) and the averaging period of the determine the cause of every alarm according to the requirements in device, the alarm set points, and the within 1 hour of the alarm. Except as paragraphs (a)(1)(i) and (ii) of this alarm delay time. provided in paragraph (c)(2)(vi) of this section. (v) Following initial adjustment, you section, you must alleviate the cause of (i) You must conduct weekly visual shall not adjust the averaging period, the alarm within 3 hours of the alarm by inspections of the system ductwork for alarm set point, or alarm delay time taking whatever corrective action(s) are leaks. without approval from the necessary. Corrective actions may (ii) You must conduct inspections of Administrator or delegated authority include, but are not limited to the the interior of the baghouse for except as provided in paragraph following: structural integrity and to determine the (c)(1)(vi) of this section. (i) Inspecting the fabric filter for air condition of the fabric filter every 12 (vi) Once per quarter, you may adjust leaks, torn or broken bags or filter months. the sensitivity of the bag leak detection media, or any other condition that may (2) As an alternative to the monitoring system to account for seasonal effects, cause an increase in PM emissions; requirements in paragraph (a)(1) of this including temperature and humidity, (ii) Sealing off defective bags or filter section, you may demonstrate according to the procedures identified media; compliance by conducting a daily 30- in the site-specific monitoring plan (iii) Replacing defective bags or filter minute visible emissions (VE) test (i.e., required by paragraph (c)(2) of this media or otherwise repairing the control no visible emissions) using EPA Method section. device; 22 (40 CFR part 60, appendix A–7). (vii) You must install the bag leak (iv) Sealing off a defective fabric filter (b) If the results of the visual detection sensor downstream of the compartment; inspection or VE test conducted under fabric filter. (v) Cleaning the bag leak detection paragraph (a) of this section indicate a (viii) Where multiple detectors are system probe or otherwise repairing the problem with the operation of the required, the system’s instrumentation bag leak detection system; or baghouse, including but not limited to and alarm may be shared among (vi) Shutting down the process air leaks, torn or broken bags or filter detectors. producing the PM emissions. media, or any other condition that may (2) You must develop and submit to cause an increase in PM emissions, you the Administrator or delegated authority § 63.11469 What are the notification must take immediate corrective action for approval a site-specific monitoring requirements? to return the baghouse to normal plan for each bag leak detection system. (a) You must submit the Initial operation according to the equipment You must operate and maintain the bag Notification required by § 63.9(a)(2) no manufacturer’s specifications or leak detection system according to the later than 120 calendar days after the instructions and record the corrective site-specific monitoring plan at all applicable compliance date specified in action taken. times. Each monitoring plan must § 63.11464. The Initial Notification must

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include the information specified in Notification or Notification of magnesium processing, or secondary paragraphs (a)(1) through (3) of this Compliance Status that you submitted. zinc processing plant that uses furnace section and may be combined with the (2) You must keep the records of all melting operations to melt post- Notification of Compliance Status inspection and monitoring data required consumer nonferrous metal scrap to required in § 63.11467 and paragraph (b) by § 63.11467 and § 63.11468, and the make products including bars, ingots, of this section. information identified in paragraphs and blocks, or metal powders. (1) The name and address of the (a)(2)(i) through (a)(2)(v) for each owner or operator; required inspection or monitoring. § 63.11473 Who implements and enforces this subpart? (2) The address (i.e., physical (i) The date, place, and time; location) of the affected source; and (ii) Person conducting the activity; (a) This subpart can be implemented (3) An identification of the relevant (iii) Technique or method used; and enforced by the U.S. EPA or a standard, or other requirement, that is (iv) Operating conditions during the delegated authority such as your State, the basis of the notification and source’s activity; and local, or tribal agency. If the U.S. EPA compliance date. (v) Results. Administrator has delegated authority to (b) You must submit a Notification of (b) Your records must be in a form your State, local, or tribal agency, then Compliance Status required by § 63.9(h) suitable and readily available for that agency has the authority to no later than 120 days after the expeditious review, according to implement and enforce this subpart. applicable compliance date specified in § 63.10(b)(1). You should contact your U.S. EPA § 63.11464. In addition to the (c) As specified in § 63.10(b)(1), you Regional Office to find out if this information required in § 63.9(h)(2)and must keep each record for 5 years subpart is delegated to your State, local, § 63.11367, your notification must following the date of each recorded or tribal agency. include the following certification(s) of action. (b) In delegating implementation and compliance, as applicable, and signed (d) You must keep each record onsite enforcement authority of this subpart to by a responsible official: for at least 2 years after the date of each a State, local, or tribal agency under 40 (1) This certification of compliance by recorded action according to CFR part 63, subpart E, the authorities the owner or operator of an existing § 63.10(b)(1). You may keep the records contained in paragraph (c) of this affected source who is relying on a offsite for the remaining 3 years. section are retained by the Administrator of the U.S. EPA and are previous performance test: ‘‘This facility Other Requirements and Information complies with the control efficiency not transferred to the State, local, or requirement in § 63.11465 based on a § 63.11471 What General Provisions apply tribal agency. previous performance test in accordance to this subpart? (c) The authorities that will not be with § 63.11466.’’ Table 1 to this subpart shows which delegated to State, local, or tribal (2) This certification of compliance by parts of the General Provisions in agencies are listed in paragraphs (c)(1) the owner or operator of any new or §§ 63.1 through 63.16 apply to you. through (4) of this section. existing affected source: ‘‘This facility (1) Approval of alternatives to the has conducted an initial inspection of § 63.11472 What definitions apply to this applicability requirements in § 63.11462 subpart? each control device according to the and 63.11463, the compliance date requirements in § 63.11467, will Terms used in this subpart are requirements in § 63.11464, and the conduct periodic inspections and defined in the Clean Air Act, in § 63.2, applicable standards in § 63.11465. maintenance of control devices in and in this section as follows: (2) Approval of a major change to a accordance with § 63.11468, and will Bag leak detection system means a test method under § 63.7(e)(2)(ii) and (f). maintain records of each inspection and system that is capable of continuously A ‘‘major change to test method’’ is maintenance action required by monitoring relative particulate matter defined in § 63.90. § 63.11470.’’ (dust loadings) in the exhaust of a (3) Approval of a major change to (3) This certification of compliance by baghouse to detect bag leaks and other monitoring under § 63.8(f). A ‘‘major the owner or operator of a new affected upset conditions. A bag leak detection change to monitoring’’ is defined in source: ‘‘This facility has an approved system includes, but is not limited to, § 63.90. bag leak detection system monitoring an instrument that operates on (4) Approval of a major change to plan in accordance with triboelectric, light scattering, light recordkeeping/reporting under § 63.11468(c)(2).’’ transmittance, or other effect to § 63.10(f). A ‘‘major change to continuously monitor relative recordkeeping/reporting’’ is defined in § 63.11470 What are the recordkeeping particulate matter loadings. § 63.90. requirements? Furnace melting operation means the (a) You must keep the records collection of processes used to charge § 63.11474 [Reserved] specified in paragraphs (a)(1) and (2) of post-consumer nonferrous scrap Tables to Subpart TTTTTT of Part 63 this section. material to a furnace, melt the material, (1) As required in § 63.10(b)(2)(xiv), and transfer the molten material to a As stated in § 63.11470, you must you must keep a copy of each forming medium. comply with the requirements of the notification that you submitted to Secondary nonferrous metals NESHAP General Provisions (40 CFR comply with this subpart and all processing facility means a brass and part 63, subpart A) shown in the documentation supporting any Initial bronze ingot making, secondary following table:

TABLE 1 TO SUBPART TTTTTT OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART TTTTTT

Citation Subject

63.1(a)(1)–(a)(4), (a)(6), (a)(10)–(a)(12), (b)(1), (b)(3), (c)(1) 1, (c)(2), Applicability. (c)(5), (e). 63.2 ...... Definitions.

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TABLE 1 TO SUBPART TTTTTT OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART TTTTTT— Continued

Citation Subject

63.3 ...... Units and Abbreviations. 63.4 ...... Prohibited Activities and Circumvention. 63.6(a), (b)(1)–(b)(5), (b)(7), (c)(1), (c)(2), (c)(5), (e)(1), (f), (g), (i), (j) ... Compliance with Standards and Maintenance Requirements. 63.8(a)(1), (a)(2), (b), (c)(1)(i)–(c)(1)(ii), (c)(2), (c)(3), (f) ...... Monitoring Requirements. 63.9(a), (b)(1), (b)(2), (b)(5), (c), (d), (h)(1)–(h)(3), (h)(5), (h)(6), (i), (j) .. Notification Requirements. 63.10(a), (b)(1), (b)(2)(vii), (b)(2)(xiv), (b)(3), (c), (f) ...... Recordkeeping and Reporting Requirements. 63.12 ...... State Authority and Delegations. 63.13 ...... Addresses. 63.14 ...... Incorporations by Reference. 63.15 ...... Availability of Information and Confidentiality. 63.16 ...... Performance Track Provisions. 1 Section 63.11462(b) of this subpart exempts area sources from the obligation to obtain title V operating permits.

[FR Doc. E7–18344 Filed 9–19–07; 8:45 am] BILLING CODE 6560–50–P

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Part IV

Department of Housing and Urban Development Federal Housing Administration (FHA) Single Family Mortgage Insurance: Announcement of Planned Implementation of Risk-Based Premiums; Notice

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DEPARTMENT OF HOUSING AND comments electronically. Electronic been assigned on or after January 1, URBAN DEVELOPMENT submission of comments allows the 2008. Section 203(c)(2) of the National commenter maximum time to prepare Housing Act (12 U.S.C. 1709(c)(2)) [Docket No. FR–5171–N–01] and submit a comment, ensures timely establishes mortgage insurance Federal Housing Administration (FHA) receipt by HUD, and enables HUD to premiums for most FHA single family Single Family Mortgage Insurance: make them immediately available for programs. Such upfront and annual Announcement of Planned public viewing. Commenters should insurance premiums are set at levels not Implementation of Risk-Based follow the instructions provided at to exceed 2.25 percent and 0.50 percent Premiums http://www.regulations.gov to submit (0.55 percent for mortgages involving an comments electronically. original principal obligation that is AGENCY: Office of the Assistant No Facsimile Comments. Facsimile greater than 95 percent of the appraised Secretary for Housing—Federal Housing (FAX) comments are not acceptable. In value of the property), respectively, Commissioner, HUD. all cases, communications must refer to with a discount available on the upfront ACTION: Notice. the docket number and title. premiums for mortgagors who are first- Public Inspection of Public time homebuyers and who successfully SUMMARY: This notice applies to FHA Comments. All comments and complete pre-purchase homeownership single family mortgage insurance communications submitted will be counseling approved by the Secretary. programs. This notice announces FHA’s available, without revision, for planned implementation of risk-based inspection and downloading at http:// By offering a range of premiums based premiums, which are designed for www.regulations.gov. Comments are on risk, FHA will be able to offer mortgage lenders to offer borrowers an also available for public inspection and options to mortgagees serving borrowers FHA-insured product that provides a copying between 8 a.m. and 5 p.m. who were previously underserved, or range of mortgage insurance premium weekdays at the Regulations Division. not served, by the conventional pricing, based on the risk the insurance Due to security measures at the HUD marketplace. Alternatively, FHA will contract represents. Headquarters building, please schedule also be able to offer options to DATES: Comment Due Date: October 22, an appointment to review the comments mortgagees serving those borrowers 2007. by calling the Regulations Division at wishing to lower their premiums by, for example, increasing their downpayment ADDRESSES: Interested persons are (202) 708–3055 (this is not a toll-free or by improving their credit scores. A invited to submit comments regarding number). range of premiums based on risk will this notice to the Regulations Division, FOR FURTHER INFORMATION CONTACT: also ensure the future financial Office of General Counsel, Department Margaret Burns, Director, Office of of Housing and Urban Development, Single Family Program Development, soundness of FHA programs that are 451 Seventh Street, SW., Room 10276, Department of Housing and Urban obligations of the Mutual Mortgage Washington, DC 20410–0500. Development, 451 Seventh Street, SW., Insurance Fund (MMIF). Under risk- Communications should refer to the Washington, DC 20410; telephone (202) based premiums, however, no qualified above docket number and title. 708–2121 (this is not a toll-free borrower will be charged by the Comment by Mail. Please note that number). Persons with hearing or mortgage lender in excess of the current due to security measures at all federal speech impairments may access this statutory upfront and annual mortgage agencies, submission of comments by number through TTY by calling the toll- insurance premium limits. Additionally, mail often results in delayed delivery. free Federal Information Relay Service this notice, when issued in final, will Electronic Submission of Comments. at (800) 877–8339. replace FHA’s Mortgagee Letter 00–38, which identifies the current mortgage HUD now accepts comments SUPPLEMENTARY INFORMATION: electronically, which interested persons insurance premiums for FHA’s single may now submit through the Federal I. Risk-Based Premiums family programs. eRulemaking Portal at http:// This notice announces HUD’s plan to Risk-based premiums will utilize the www.regulations.gov. HUD strongly implement risk-based premiums for following schedule for upfront mortgage encourages commenters to submit FHA loans for which case numbers have insurance premium rates:

FHA SINGLE FAMILY MORTGAGE INSURANCE UPFRONT MORTGAGE INSURANCE PREMIUMS—EFFECTIVE AS OF JANUARY 1, 2008 [All premiums are specified in basis points (0.01%)]

Minimum Decision Credit Score Downpayment a (%) 850–680 679–640 639–600 599–560 559–500 499–300 None

Funds from Borrower or a Relative ...... 10 75 100 125 150 175 175 200 5 100 125 150 175 200 ...... 225 3 125 150 175 200 225 ...... Other Sources of Funds ...... 3 175 200 b 225 ...... a. Premiums are based on two categories of sources of funds: (1) The borrower’s own funds or gifts from relatives and (2) any other accept- able source. See HUD Handbook 4155.1 for guidance on acceptable sources of funds. b. A minimum decision credit score of 620 is required when downpayment funds come from a source other than the borrower or a relative of the borrower. Notes: 1. Annual premium rates are: 50 basis points for loans with 5 and 10 percent downpayments; 55 basis points for loans with 3 percent downpayments; and 25 basis points for all loans with amortization terms of 15 years or less.

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2. Downpayment percentage is determined by the base loan-to-value ratio (LTV). The ‘‘base LTV’’ is calculated by: (1) Dividing the base mort- gage amount by the lesser of the sales price or appraised value of the property (for refinances, the base mortgage is divided by the appraised value of the property); (2) subtracting the result from 1 (one); and (3) multiplying by 100. ‘‘Base mortgage amount’’ is defined as the mortgage amount prior to adding any financed closing costs or upfront mortgage insurance. 3. Eligibility for the mortgage insurance premiums listed in the chart above is based on an applicant’s decision credit score (FICO). A ‘‘decision credit score’’ is determined for each applicant according to the following guidelines: when three scores are available (one from each repository), the median (middle) value is used; when only two are available, the lesser of the two is chosen; when only one is available, then that score is used. If more than one individual is applying for the same mortgage, the lender should determine the decision credit score for each individual borrower and then average them to determine the final decision credit score for the application. That application ‘‘decision’’ credit score is then used to underwrite and determine if the mortgage is considered an acceptable risk. 4. Except as provided below, eligibility for these insurance premiums is dependent upon borrower acceptance by TOTAL (Technology Open to Approved Lenders). Therefore, all borrowers with valid credit scores must be scored by TOTAL. 5. Borrowers not scored by TOTAL or with insufficient trade lines to generate credit bureau scores are considered as ‘‘none’’ in the premium chart and are priced accordingly. Borrowers falling into cells with no premium price shown are not eligible for FHA-insured financing. 6. If TOTAL refers a loan for manual underwriting and the underwriter deems that there are sufficient compensating factors to create an ac- ceptable risk to FHA, then the upfront insurance premium charge will be as shown on the premium chart. 7. These premiums apply to all purchase loans and to fully underwritten (non-streamline) refinance loans. Cash-out refinance loans must meet a minimum 5 percent equity requirement, based on the appraised value of the property. 8. Streamline refinance of an existing FHA loan for which a case number was assigned prior to January 1, 2008, will have an upfront premium of 100 basis points and an annual premium of 50 basis points. 9. First-time homebuyers who would otherwise pay an upfront premium of 225 basis points, but who complete pre-purchase homeownership counseling acceptable to the Secretary, will pay an upfront premium of no more than 200 basis points.

II. Solicitation of Public Comments Any changes made to the risk-based this notice is categorically excluded FHA welcomes comments on the risk- premiums in response to public from the requirements of the National based premiums for a period of 30 days. comment will be announced through Environmental Policy Act (42 U.S.C. The risk-based premiums are based on publication of a subsequent notice in 4332 et seq.). the Federal Register. FHA insurance eligibility requirements Dated: September 13, 2007. as they exist at the time of publication III. Findings and Certifications Brian D. Montgomery, of this notice. FHA’s proposed rule on downpayment assistance, if issued in Environmental Review Assistant Secretary for Housing—Federal Housing Commissioner. final, would affect the risk-based A Finding of No Significant Impact is premiums proposal contained in this not required for this notice. Under 24 [FR Doc. 07–4651 Filed 9–17–07; 10:16 am] notice. CFR 50.19(b)(6), the subject matter of BILLING CODE 4210–67–P

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Part V

Department of Housing and Urban Development 24 CFR Parts 14, 15, et al. HUD Office of Hearings and Appeals Conforming Amendments; and Technical Correction to Part 15 Regulations; Final Rule

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DEPARTMENT OF HOUSING AND I. Background part 15 regulations codified in the 2006 URBAN DEVELOPMENT Section 847 of the 2006 NDA Act edition of title 24 of the Code of Federal (Pub. L. 109–163, approved January 6, Regulations. Section 15.203(a) of the 24 CFR Parts 14, 15, 17, 20, 24, 25, 26, 2006) (41 U.S.C. 438) established the 2006 codified regulations references and 180 Civilian Board of Contract Appeals Regional Counsel, and HUD intended to within the General Services include the same reference in the new [Docket No. FR–5137–F–01] Administration and gave it jurisdiction § 15.203(b) of the February 26, 2007, to decide contract disputes from several final rule. This rule provides for such RIN 2501–AD32 civilian agencies. The 2006 NDA Act inclusion. simultaneously terminated the Boards of III. Justification for Final Rulemaking HUD Office of Hearings and Appeals Contract Appeals of eight federal In general, HUD publishes a rule for Conforming Amendments; and agencies, excepting the boards of public comment before issuing a rule for Technical Correction to Part 15 contract appeals of the Department of effect, in accordance with HUD’s Regulations Defense, the Tennessee Valley regulations on rulemaking at 24 CFR Authority, and the U.S. Postal Service. AGENCY: Office of the Secretary, HUD. part 10. Part 10, however, allows in As a result, the affected eight federal ACTION: Final rule. § 10.1 for omission of notice and public agencies, including HUD, no longer comment in cases of statements of have a board of contract appeals as part SUMMARY: This final rule revises HUD’s policy, interpretive rules, rules of their organizational structure. regulations to reflect the statutorily governing the Department’s organization Because of the transfer of contract mandated termination of the HUD Board or internal practices, or if a statute appeals adjudicatory responsibilities of Contract Appeals. As required by the expressly provides for omission of under the 2006 NDA Act, and to provide National Defense Authorization Act for notice and public comment. In this case, the nonprocurement contract dispute Fiscal Year 2006 (2006 NDA Act), the public comment is unnecessary because functions performed by the former HUD contract-related functions of the HUD the majority of this rule reflects the Board of Contract Appeals, HUD has Board of Contract Appeals have been Department’s organization resulting established within the Office of the transferred to the new Civilian Board of from the termination of the HUD Board Secretary a new OHA (71 FR 76679, Contract Appeals. This final rule also of Contract Appeals, pursuant to the December 21, 2006). The OHA consists describes the organization, address, and 2006 NDA Act. More specifically, this of two separate divisions, the existing officer qualifications of the new Office final rule removes regulations relating to Office of Administrative Law Judges and of Hearings and Appeals (OHA) and its the former HUD Board of Contract the new Office of Appeals. The Office of two divisions, which will carry out the Appeals and describes the organization Appeals includes Administrative Judges nonprocurement functions performed of the new OHA. It also reflects the who perform certain nonprocurement by the former HUD Board of Contract reassignment of nonprocurement contract appeals functions that were Appeals. This rule also makes functions previously carried out by the provided by the Administrative Judges conforming changes to other HUD former HUD Board of Contract Appeals of the former HUD Board of Contract regulations to reflect this organizational elsewhere within the Department. Appeals. change. Additionally, this rule makes a Similarly, the correction to part 15 technical correction to HUD’s Freedom II. Final Rule merely outlines the procedures used by of Information Act (FOIA) regulations to the Department to be followed when a include reference to Regional Counsel, This final rule revises the regulations in 24 CFR part 20, which governed the subpoena, order, or other demand of a which was inadvertently omitted from a court is issued to HUD for the disclosure previously published rule. establishment and operation of the former HUD Board of Contract Appeals. of material or for the disclosure of DATES: Effective Date: October 22, 2007. Specifically, this rule describes the information in its possession. This FOR FURTHER INFORMATION CONTACT: OHA’s organization, address, and officer correction reflects current HUD Questions regarding the establishment qualifications. This rule also makes practices. The amendment made by this and organization of the OHA should be conforming changes to regulations in part of this rule does not affect the rights directed to David T. Anderson, Director, parts 14, 17, 20, 24, 25, 26, and 180 that or obligations of members of the public. Office of Hearings and Appeals, reference the former HUD Board of IV. Findings and Certifications Department of Housing and Urban Contract Appeals. It also reflects the Development, 1707 H Street, NW., new address of the Office of Impact on Small Entities Eleventh Floor, Washington, DC 20006; Administrative Law Judges throughout The Regulatory Flexibility Act (5 telephone number (202) 254–0000 (this HUD’s regulations. U.S.C. 601 et seq.) generally requires an is not a toll-free number). Questions In addition, this rule makes a agency to conduct a regulatory regarding the technical correction to the technical amendment to HUD’s FOIA flexibility analysis of any rule subject to part 15 regulations should be directed to regulations in 24 CFR part 15. HUD notice and comment rulemaking Allen Villafuerte, Office of General published a final rule on February 26, requirements, unless the agency certifies Counsel, Department of Housing and 2007 (72 FR 8580) to clarify the types that the rule will not have a significant Urban Development, 451 Seventh Street, of requests for HUD documents and economic impact on a substantial SW., Room 10258, Washington, DC employee testimony covered by the number of small entities. This final rule 20410–0500; telephone number (202) Department’s document production and does not establish special procedures 708–0300, extension 5095 (this is not a testimony approval regulations. In that would need to be complied with by toll-free number). Hearing-or speech- HUD’s amendments to § 15.203 in the small entities. This rule does not change impaired individuals may access these February 26, 2007, final rule, HUD the procedures that all entities, small telephone numbers via TTY by calling inadvertently omitted reference to and large, must follow in the course of the toll-free Federal Information Relay Regional Counsel in § 15.203(b). Section certain hearings and appellate review Service at (800) 877–8339. 15.203(b) in the February 26, 2007, final processes. Accordingly, the undersigned SUPPLEMENTARY INFORMATION: rule largely mirrors § 15.203(a) of the certifies that this final rule would not

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have a significant economic impact on 24 CFR Part 20 Department for the production of a substantial number of small entities. Administrative practice and material or provision of testimony, the employee shall immediately notify the Environmental Impact procedure, Government contracts, Organization and functions Associate General Counsel for This proposed rule does not direct, (Government agencies). Litigation, or the appropriate Regional provide for assistance or loan and Counsel, or other designee. The mortgage insurance for, or otherwise 24 CFR Part 24 appropriate Regional Counsel shall govern or regulate, real property Administrative practice and mean the Regional Counsel for the acquisition, disposition, leasing, procedure, Government contracts, Grant Regional Office having delegated rehabilitation, alteration, demolition, or programs, Loan programs, Reporting authority over the project or activity new construction, nor does it establish, and recordkeeping requirements. with respect to which the information is revise, or provide for standards for sought. The Associate General Counsel construction or construction materials, 24 CFR Part 25 for Litigation, the appropriate Regional manufactured housing, or occupancy. Administrative practice and Counsel, or other designee shall Accordingly, under 24 CFR 50.19(c)(1), procedure, Loan programs—housing maintain a record of all demands served this proposed rule is categorically and community development, upon the Department and refer the excluded from environmental review Organization and functions demand to the appropriate designee for under the National Environmental (Government agencies), Reporting and processing and determination. Policy Act of 1969 (42 U.S.C. 4321 et recordkeeping requirements. seq.). PART 17—ADMINISTRATIVE CLAIMS 24 CFR Part 26 Executive Order 13132, Federalism Administrative practice and I 5. The authority citation for part 17 Executive Order 13132 (entitled procedure. continues to read as follows: ‘‘Federalism’’) prohibits an agency from 24 CFR Part 180 Authority: 5 U.S.C. 5514, 28 U.S.C. 2672; publishing any rule that has federalism 31 U.S.C. 3711, 3716–18, 3721; and 42 U.S.C. implications, if the rule either imposes Administrative practice and 3535(d). substantial direct compliance costs on procedure, Aged, Civil rights, Fair I 6. The authority citation for subpart C state and local governments and is not housing, Individuals with disabilities, continues to read as follows: required by statute, or the rule preempts Investigations, Mortgages, Penalties, Reporting and recordkeeping Authority: 5 U.S.C. 5514; 31 U.S.C. 3701, state law, unless the agency meets the 3711, 3716–3720E; and 42 U.S.C. 3535(d). consultation and funding requirements requirements. of section 6 of the Executive Order. This I Accordingly, for the reasons described I 7. Revise § 17.140 to read as follows: final rule does not have federalism in the preamble, HUD amends 24 CFR parts 14, 15, 17, 20, 24, 25, 26, and 180, § 17.140 Miscellaneous provisions: implications and does not impose correspondence with the Department. substantial direct compliance costs on as follows: state and local governments nor The employee shall file an original preempt state law within the meaning of PART 14—IMPLEMENTATION OF THE and one copy of a request for a hearing the Executive Order. EQUAL ACCESS TO JUSTICE ACT IN with the Clerk, Office of the Chief ADMINISTRATIVE PROCEEDINGS Administrative Law Judge, 1707 H Unfunded Mandates Reform Act Street, NW., Eleventh Floor, I 1. The authority citation for part 14 is Washington, DC 20006, on official work Title II of the Unfunded Mandates revised to read as follows: Reform Act of 1995 (2 U.S.C. 1531– days between the hours of 8:45 a.m. and 1538) (UMRA) establishes requirements Authority: 5 U.S.C. 504(c)(1); 42 U.S.C. 5:15 p.m. All other correspondence 3535(d). for federal agencies to assess the effects shall be submitted to the Department of their regulatory actions on state, § 14.50 [Amended] Claims Officer, Office of the Chief Financial Officer, Department of local, and tribal governments and the I 2. In 24 CFR 14.50, in the definition private sector. This final rule does not Housing and Urban Development, 451 of Adjudicative officer, remove the Seventh Street, SW., Washington, DC impose any federal mandates on any words ‘‘Board of Contract Appeals’’ and state, local, or tribal governments or the 20410. Documents may be filed by add, in their place, the words ‘‘Office of personal delivery or mail. All private sector within the meaning of Appeals’’. UMRA. documents shall be printed, typewritten, or otherwise processed in PART 15—PUBLIC ACCESS TO HUD List of Subjects clear, legible form and on letter-size RECORDS UNDER THE FREEDOM OF paper. 24 CFR Part 14 INFORMATION ACT AND TESTIMONY I 8. Revise § 17.152 to read as follows: Claims, Equal access to justice, AND PRODUCTION OF INFORMATION Lawyers, Reporting and recordkeeping BY HUD EMPLOYEES § 17.152 Review within the Department of a determination that an amount is past-due requirements. I 3. The authority citation for part 15 and legally enforceable. continues to read as follows: 24 CFR Part 15 (a) Notification by debtor. A debtor Classified information, Courts, Authority: 42 U.S.C. 3535(d). who receives a Notice of Intent has the Freedom of information, Government I 4. Revise paragraph (b) of § 15.203 to right to present evidence that all or part employees, Reporting and read as follows: of the debt is not past-due or not legally recordkeeping requirements. enforceable. The debtor should send a § 15.203 Making a demand for production copy of the Notice of Intent with a letter 24 CFR Part 17 of material or provision of testimony. notifying the Office of Appeals within Administrative practice and * * * * * 25 calendar days from the date of the procedure, Claims, Government (b) Whenever a demand is made upon Department’s Notice of Intent that he or employees, Income taxes, Wages. the Department or an employee of the she intends to present evidence. (See

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§ 17.161(a) for address of the Office of Street, NW, Eleventh Floor, Washington, PART 24—GOVERNMENT Appeals.) Failure to give this advance DC 20006. DEBARMENT AND SUSPENSION notice will not jeopardize the debtor’s * * * * * (NONPROCUREMENT) right to present evidence within the 65 I days provided for in paragraph (b) of 10. Revise § 17.170(b) to read as I 12. The authority citation for part 24 this section. If the Office of Appeals has follows: continues to read as follows: additional procedures governing the * * * * * Authority: 41 U.S.C. 701 et seq.; 42 U.S.C. review process, a copy of the procedures (b) Hearing official. Any hearing 3535(d); Sec. 2455, Pub. L. 103–355, 108 Stat. will be mailed to the debtor after his required to establish the Secretary’s 3327 (31 U.S.C. 6101 note); E.O. 12549 (3 request for review is received and right to collect a debt through CFR, 1986 Comp., p. 189); E.O. 12689 (3 CFR, 1989 Comp., p. 235). docketed by the Office of Appeals. administrative wage garnishment shall (b) Submission of evidence. The be conducted by an Administrative § 24.947 [Amended] debtor may submit evidence showing Judge of the Office of Appeals. I 13. In 24 CFR 24.947, remove the that all or part of the debt is not past- I 11. Revise part 20 to read as follows: words ‘‘Board of Contract Appeals’’ and due or not legally enforceable, along add, in their place, the words ‘‘Office of with the notification requested by PART 20—OFFICE OF HEARINGS AND Appeals’’. paragraph (a) of this section, but in any APPEALS event the evidence must be submitted to PART 25—MORTGAGEE REVIEW the Office of Appeals within 65 calendar Sec. BOARD days from the date of the Department’s 20.1 Establishment of the Office of Hearings Notice of Intent. Failure to submit and Appeals. I 14. The authority citation for 24 CFR evidence within 65 calendar days will 20.3 Location, organization, and officer part 25 continues to read as follows: qualifications. result in a dismissal of the request for 20.5 Jurisdiction of Office of Appeals. Authority: 12 U.S.C. 1708(c), 1708(d), review by the Office of Appeals. 1709(s), 1715b, and 1735f–14; 42 U.S.C. (c) Review of the record. After a timely Authority: 42 U.S.C. 3535(d). 3535(d). submission of evidence by the debtor, § 20.1 Establishment of the Office of I 15. In § 25.3, revise the definition of an Administrative Judge from the Office Hearings and Appeals. Hearing officer to read as follows: of Appeals will review the evidence submitted by the Department that shows There is established in the Office of § 25.3 Definitions. that all or part of the debt is past-due the Secretary the Office of Hearings and Appeals. * * * * * and legally enforceable. (Administrative Hearing officer. An Administrative Judges are appointed in accordance with § 20.3 Location, organization, and officer Law Judge authorized by the Secretary, 41 U.S.C. 607(b)(1).) The Administrative qualifications. or by the Secretary’s designee, to issue Judge shall make a determination based findings of fact or other appropriate upon a review of the written record, (a) Location. The Office of Hearings and Appeals is located at 1707 H Street, findings under § 25.8(d)(2). except that the Administrative Judge * * * * * may order an oral hearing if he or she NW, Eleventh Floor, Washington, DC 20006. The telephone number of the finds that: PART 26—HEARING PROCEDURES Office of Hearings and Appeals is (202) (1) An applicable statute authorizes or 254–0000. Hearing- or speech-impaired requires the Secretary to consider I 16. The authority citation for part 26 individuals may access this number via waiver of the indebtedness and the continues to read as follows: TTY by calling the toll-free Federal waiver determination turns on Information Relay Service at (800) 877– Authority: 42 U.S.C. 3535(d). credibility or veracity; or 8339. The facsimile number is (202) (2) The question of indebtedness § 26.2 [Amended] 254–0011. cannot be resolved by review of the I 17. In 24 CFR 26.2(a), remove the documentary evidence. (b) Organization. The Office of words ‘‘Board of Contract Appeals’’ and (d) Previous decision by the Office of Hearings and Appeals consists of two add, in their place, the words ‘‘Office of Appeals. The debtor is not entitled to a divisions: the Office of Administrative Appeals’’. review of the Department’s intent to Law Judges and the Office of Appeals. Its administrative activities are I 18. In § 26.28, revise the definition of offset it if, in a previous year, the Office Chief Docket Clerk to read as follows: of Appeals has issued a decision on the supervised by the Director of the Office merits that the debt is past-due and of Hearings and Appeals. § 26.28 Definitions. legally enforceable, except when the (c) Officer qualifications. The * * * * * debt has become legally unenforceable Director, Administrative Judges, and Chief Docket Clerk means the Chief since the issuance of that decision or Administrative Law Judges of the Office Docket Clerk of the Office of when the debtor can submit newly of Hearings and Appeals shall be Administrative Law Judges at the discovered material evidence that the attorneys at law duly licensed by any following address: 1707 H Street, NW., debt is presently not legally enforceable. state, commonwealth, territory, or the Eleventh Floor, Washington, DC 20006. I 9. Revise § 17.161(a) to read as District of Columbia. * * * * * follows: § 20.5 Jurisdiction of Office of Appeals. PART 180—CONSOLIDATED HUD § 17.161 Correspondence with the The Office of Appeals shall, HEARING PROCEDURES FOR CIVIL Department. consistent with statute and regulation, RIGHTS MATTERS (a) All correspondence from the have jurisdiction over matters assigned debtor to the Office of Appeals to it by the Secretary or designee. I 19. The authority citation for part 180 concerning the right to review as Determinations shall have the finality continues to read as follows: described in § 17.152 shall be addressed provided by the applicable statute, Authority: 29 U.S.C. 794; 42 U.S.C. 2000d– to the HUD Office of Appeals, 1707 H regulation, or agreement. 1 3535(d), 3601–3619; 5301–5320, and 6103.

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I 20. In § 180.100(c), revise the Chief Docket Clerk is the docket clerk Dated: August 13, 2007. definition of Chief Docket Clerk to read for HUD’s Office of Administrative Law Roy A. Bernardi, as follows: Judges, 1707 H Street, NW., Eleventh Deputy Secretary. Floor, Washington, DC 20006. The [FR Doc. E7–18522 Filed 9–19–07; 8:45 am] § 180.100 Definitions. telephone number is (202) 254–0000 BILLING CODE 4210–67–P * * * * * and the facsimile number is (202) 254– (c) * * * 0011. * * * * *

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Part VI

Department of the Interior Fish and Wildlife Service

50 CFR Part 20 Migratory Bird Hunting; Final Frameworks for Late-Season Migratory Bird Hunting Regulations; Final Rule

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DEPARTMENT OF THE INTERIOR proposals for early- and late-season excerpted from various reports was migratory bird hunting regulations and included in the August 31 supplemental Fish and Wildlife Service the regulatory alternatives for the 2007– proposed rule. For more detailed 08 duck hunting season. The June 8 information on methodologies and 50 CFR Part 20 supplement also provided detailed results, complete copies of the various RIN 1018–AV12 information on the 2007–08 regulatory reports are available at the address schedule and announced the Service indicated under ADDRESSES or from our Migratory Bird Hunting; Final Migratory Bird Regulations Committee Web site at http://www.fws.gov/ Frameworks for Late-Season Migratory (SRC) and Flyway Council meetings. migratorybirds/reports/reports.html. Bird Hunting Regulations On June 20 and 21, we held open meetings with the Flyway Council Review of Public Comments and AGENCY: Fish and Wildlife Service, Consultants, at which the participants Flyway Council Recommendations Interior. reviewed information on the current The preliminary proposed ACTION: Final rule. status of migratory shore and upland rulemaking, which appeared in the game birds and developed April 11, 2007, Federal Register, SUMMARY: The Fish and Wildlife Service recommendations for the 2007–08 opened the public comment period for (Service or we) prescribes final late- regulations for these species plus migratory game bird hunting season frameworks from which States regulations for migratory game birds in regulations. The supplemental proposed may select season dates, limits, and Alaska, Puerto Rico, and the Virgin rule, which appeared in the June 8, other options for the 2007–08 migratory Islands; special September waterfowl 2007, Federal Register, discussed the bird hunting seasons. These late seasons seasons in designated States; special sea regulatory alternatives for the 2007–08 include most waterfowl seasons, the duck seasons in the Atlantic Flyway; duck hunting season. Late-season earliest of which commences on and extended falconry seasons. In comments are summarized below and September 22, 2007. The effect of this addition, we reviewed and discussed numbered in the order used in the April final rule is to facilitate the States’( preliminary information on the status of 11 Federal Register. We have included selection of hunting seasons and to waterfowl as it relates to the only the numbered items pertaining to further the annual establishment of the development and selection of the late-season issues for which we received late-season migratory bird hunting regulatory packages for the 2007–08 written comments. Consequently, the regulations. regular waterfowl seasons. On July 23, issues do not follow in direct numerical DATES: This rule takes effect on 2007, we published in the Federal or alphabetical order. September 20, 2007. Register (72 FR 40194) a third document We received recommendations from specifically dealing with the proposed all four Flyway Councils. Some ADDRESSES: States should send their frameworks for early-season regulations. recommendations supported season selections to: Chief, Division of In the August 28, 2007, Federal Register continuation of last year’s frameworks. Migratory Bird Management, U.S. Fish (72 FR 49622), we published final Due to the comprehensive nature of the and Wildlife Service, Department of the frameworks for early migratory bird annual review of the frameworks Interior, ms MBSP–4107–ARLSQ, 1849 hunting seasons from which wildlife performed by the Councils, support for C Street, NW., Washington, DC 20240. conservation agency officials from the continuation of last year’s frameworks is You may inspect comments during States, Puerto Rico, and the Virgin assumed for items for which no normal business hours at our office in Islands selected 2007–08 early-season recommendations were received. room 4107, 4501 N. Fairfax Drive, hunting dates, hours, areas, and limits. Council recommendations for changes Arlington, Virginia. On August 30, 2007, we published a in the frameworks are summarized FOR FURTHER INFORMATION CONTACT: final rule in the Federal Register (72 FR below. Robert Blohm, Chief, or Ron W. Kokel, 50164) amending subpart K of title 50 General Division of Migratory Bird Management, CFR part 20 to set hunting seasons, U.S. Fish and Wildlife Service, (703) hours, areas, and limits for early Written Comments: An individual 358–1714. seasons. commenter protested the entire SUPPLEMENTARY INFORMATION: On August 1–2, 2007, we held open migratory bird hunting regulations meetings with the Flyway Council process, the killing of all migratory Regulations Schedule for 2007 Consultants, at which the participants birds, and the Flyway Council process. On April 11, 2007, we published in reviewed the status of waterfowl and Service Response: Our long-term the Federal Register (72 FR 18328) a developed recommendations for the objectives continue to include providing proposal to amend 50 CFR part 20. The 2007–08 regulations for these species. opportunities to harvest portions of proposal provided a background and On August 31, 2007, we published in certain migratory game bird populations overview of the migratory bird hunting the Federal Register (72 FR 50613) the and to limit harvests to levels regulations process, and dealt with the proposed frameworks for the 2007–08 compatible with each population’s establishment of seasons, limits, late-season migratory bird hunting ability to maintain healthy, viable proposed regulatory alternatives for the regulations. This document establishes numbers. Having taken into account the 2007–08 duck hunting season, and other final frameworks for late-season zones of temperature and the regulations for hunting migratory game migratory bird hunting regulations for distribution, abundance, economic birds under §§ 20.101 through 20.107, the 2007–08 season. We will publish value, breeding habits, and times and 20.109, and 20.110 of subpart K. Major State selections in the Federal Register lines of flight of migratory birds, we steps in the 2007–08 regulatory cycle as amendments to §§ 20.101 through believe that the hunting seasons relating to open public meetings and 20.107, and 20.109 of title 50 CFR part provided herein are compatible with the Federal Register notifications were also 20. current status of migratory bird identified in the April 11 proposed rule. populations and long-term population On June 8, 2007, we published in the Population Status and Harvest goals. Additionally, we are obligated to, Federal Register (72 FR 31789) a second A brief summary of information on and do, give serious consideration to all document providing supplemental the status and harvest of waterfowl information received as public

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comment. While there are problems Atlantic Flyway should continue to the Central Flyway; the season length inherent with any type of representative depend on the status of eastern for pintails and canvasbacks in season- management of public-trust resources, mallards. Investigations of the dynamics within-a-season States under the we believe that the Flyway-Council of western mallards (and their potential ‘‘liberal’’ alternative will be 39 days. system of migratory bird management effect on regulations in the West) are Five States (Kansas, North Dakota, has been a longstanding example of continuing; therefore we are not yet South Dakota, Texas, and Wyoming) State-Federal cooperative management prepared to recommend an AHM were randomly assigned to Hunter’s since its establishment in 1952. protocol for this mallard stock. Choice regulations and the remaining However, as always, we continue to For the 2007 hunting season, we five States (Colorado, Montana, seek new ways to streamline and considered the same regulatory Nebraska, New Mexico, and Oklahoma) improve the process. alternatives as those used last year. The serve as controls (season-within-a- nature of the restrictive, moderate, and season regulations) as the evaluation 1. Ducks liberal alternatives has remained proceeds. The overall duck daily bag Categories used to discuss issues essentially unchanged since 1997, limit is reduced from six to five for the related to duck harvest management are: except that extended framework dates Hunter’s Choice States. (A) Harvest Strategy Considerations, (B) have been offered in the moderate and While we continue to support the Regulatory Alternatives, (C) Zones and liberal regulatory alternatives since Central Flyway’s Hunter’s Choice Split Seasons, and (D) Special Seasons/ 2002. Also, we agreed in 2003 to place experiment, we reiterate that we believe Species Management. The categories a constraint on closed seasons in the implementation of this experiment correspond to previously published western three Flyways whenever the should not preclude any future changes issues/discussion, and only those midcontinent mallard breeding- in hunting regulations that may be containing recommendations are population size (traditional survey area deemed necessary on an annual basis discussed below. plus Minnesota, Michigan, and for any other duck species in the Central Wisconsin) is ≥5.5 million. A. Harvest Strategy Considerations Flyway, if such changes are deemed Optimal AHM strategies for the 2007 necessary. Council Recommendations: The hunting season were calculated using: Atlantic and Pacific Flyway Councils (1) Harvest-management objectives D. Special Seasons/Species Management and the Upper- and Lower-Regulations specific to each mallard stock; (2) the iii. Black Ducks Committees of the Mississippi Flyway 2007 regulatory alternatives; and (3) Council recommended the adoption of current population models and Council Recommendations: The the ‘‘liberal’’ regulatory alternative. associated weights for midcontinent and Atlantic Flyway Council and the Upper- The Central Flyway Council also eastern mallards. Based on this year’s and Lower-Regulations Committees of recommended the ‘‘liberal’’ alternative. survey results of 9.05 million the Mississippi Flyway Council However, as part of their Hunter’s midcontinent mallards (traditional recommended that black duck harvest Choice experiment, they recommended survey area plus MN, WI, and MI), 5.04 regulations remain unchanged for the continuation of the following bag limits: million ponds in Prairie Canada, and 2007–08 season. 906,900 eastern mallards, we believe the Service Response: For the 2007–08 In Colorado, Montana, Nebraska, New hunting season, we support the Flyway Mexico, and Oklahoma, the daily bag limit appropriate regulatory choice for all would be six ducks, with species and sex four Flyways is the ‘‘liberal’’ alternative. Councils’ recommendations for no restrictions as follows: Five mallards (no Therefore, we concur with the change in hunting regulations for black more than two of which may be females), two recommendations of the Atlantic, ducks. However, we are disappointed redheads, two scaup, two wood ducks, one Mississippi, Central, and Pacific Flyway that progress towards development of an pintail, one mottled duck, and one Councils regarding selection of the international harvest strategy stalled canvasback. For pintails and canvasbacks, ‘‘liberal’’ regulatory alternative and will during recent discussions with the the season length would be 39 days, which adopt the ‘‘liberal’’ regulatory Atlantic and Mississippi Flyways. It is may be split according to applicable zones/ our understanding that a number of key split duck hunting configurations approved alternative, as described in the June 8 for each State. Federal Register. points were debated, but consensus In Kansas, North Dakota, South Dakota, Regarding Hunter’s Choice, we could not be reached on two major Texas, and Wyoming, the daily bag limit support the Central Flyway’s issues: A suitable harvest rate objective would be five ducks, with species and sex continuation of a 3-year evaluation of and equitable allocation of the harvest restrictions as follows: Two scaup, two the Hunter’s Choice duck bag limit. The between Canada and the United States. redheads, and two wood ducks, and only one Central Flyway’s Hunter’s Choice It remains our objective to reach final from the following group—hen mallards, regulations are intended to limit harvest agreement on the international harvest mottled ducks, pintails, canvasbacks. on pintails and canvasbacks in a manner strategy in time to inform decisions for Service Response: As we stated in the similar to the season-within-a-season the 2008–09 regulatory cycle. To do so, July 23 and August 31 proposed rules, regulations. Hunter’s Choice regulations we will provide a facilitated forum, we are continuing development of an should also reduce harvests of mottled involving representatives from the Adaptive Harvest Management (AHM) ducks and hen mallards, while Service, the Canadian Wildlife Service, protocol that would allow hunting maintaining full hunting opportunity on and the Atlantic and Mississippi regulations to vary among Flyways in a abundant species such as drake Flyways, to reach consensus on the manner that recognizes each Flyway’s mallards. For the species included in parity issue and any other remaining unique breeding-ground derivation of the aggregate bag limit, the harvest of issues that currently stand in the way of mallards. Until such time, however, for one species is intended to ‘‘buffer’’ the completing and implementing this the 2007 hunting season, we believe that harvest of the others, thus reducing the revised approach to black duck harvest the prescribed regulatory choice for the harvest of all species included in the management. Failure to reach agreement Mississippi, Central, and Pacific one-bird category. The Central Flyway in time for next year’s regulations Flyways should continue to depend on has accumulated 4 years of baseline development cycle will result in our use the status of midcontinent mallards and information on harvests resulting from of the best available information to that the regulatory choice for the ‘‘season-within-a-season’’ regulations in recommend regulations necessary to

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bring harvests in line with the black daily bag limit. Therefore, we are in that might be forthcoming from the duck harvest potential. support of the Atlantic, Mississippi, and Flyways for the next regulatory cycle. Pacific Flyway Councils’ iv. Canvasbacks v. Pintails recommendations to increase the daily Council Recommendations: The bag limit for canvasbacks to two birds Council Recommendations: The Atlantic and Pacific Flyway Councils for the 2007–08 season. We also support Atlantic and Pacific Flyway Councils and the Lower-Region Regulations the Central Flyway Council’s and the Upper- and Lower-Region Committees of the Mississippi Flyway recommendation to leave canvasback Regulations Committees of the Council recommended a full season for limits unchanged in the Central Flyway Mississippi Flyway Council canvasbacks consisting of a 2-bird daily to allow continuation of the Hunter’s recommended a full season for pintails bag limit and a 60-day season in the Choice experiment in that Flyway. consisting of a 1-bird daily bag limit and Atlantic and Mississippi Flyways, and We continue to support the a 60-day season in the Atlantic and 107-day season in the Pacific Flyway. canvasback harvest strategy and the Mississippi Flyways, and a 107-day The Central Flyway Council, as part model adopted in 1994. However, this season in the Pacific Flyway. The Central Flyway Council, as part of their Hunter’s Choice experiment, strategy was developed primarily due to recommended a full season (74 days) for of their Hunter’s Choice experiment, concerns about low population levels, canvasbacks with a 1-bird daily bag recommended a full season (74 days) for and as such, did not address limit in Kansas, North Dakota, South pintails with a 1-bird daily bag limit in circumstances encountered this year of Dakota, Texas, and Wyoming and a 39- Kansas, North Dakota, South Dakota, record high abundance and the potential day season with a 1-bird daily bag limit Texas, and Wyoming and a 39-day for increased daily bag limits. We in Colorado, Montana, Nebraska, New season with a 1-bird daily bag limit in believe there is reasonable opportunity Mexico, and Oklahoma. Colorado, Montana, Nebraska, New to allow a limited increase in the daily Service Response: Since 1994, we Mexico, and Oklahoma. have followed a canvasback harvest bag limit this year without Service Response: In the July 23 strategy that if canvasback population compromising the population(s ability Federal Register, we approved the status and production are sufficient to to sustain a breeding population in incorporation of a compensatory harvest permit a harvest of one canvasback per excess of 500,000 canvasbacks next mortality model into the decision- day nationwide for the entire length of spring. making framework used in the pintail the regular duck season, while still We note, however, that departures harvest strategy. Within that framework, attaining a projected spring population from existing harvest strategies are not the compensatory model serves as an objective of 500,000 birds, the season on actions that we generally condone, nor alternative hypothesis regarding the canvasbacks should be opened. A will we make an exception to the effect of harvest mortality on population partial season would be permitted if the canvasback strategy next year, even if growth. The two alternative models estimated allowable harvest was within similar circumstances exist, without an have been assigned weights based on the projected harvest for a shortened explicit modification to the existing their respective abilities to predict season. If neither of these conditions strategy allowing for daily bag limits historic pintail breeding populations. can be met, the harvest strategy calls for greater than one bird. Over the next These weights, representing the current a closed season on canvasbacks year, we are willing to discuss the strength of evidence favoring each nationwide. possibility of revising the strategy with model, determine the influence each This year’s spring survey resulted in the Flyway Councils and other model has on the annual regulatory a record high estimate of 865,000 interested parties. Because the choice for pintails. A document canvasbacks. This was 25 percent above population model has performed describing the current pintail harvest the 2006 estimate of 691,000 relatively well to date, we believe that strategy with these technical canvasbacks and 53 percent above the the most productive area for discussion improvements is posted on the Service’s 1955–2006 average. The estimate of involves examination of the harvest webpage (http://www.fws.gov/ ponds in Prairie Canada was 5.04 management objectives of this strategy, migratorybirds/reports/reports.html). million, which was 13 percent above with an emphasis on allowing bag limits Based on this revised strategy, along last year and 49 percent above the long- greater than one bird. We believe that with an observed spring breeding term average. The size of the spring such a revision should carefully population of 3.34 million, an population, together with above-average consider the potential ramifications of overflight-bias-corrected breeding expected production due to the good such changes on the expected frequency population of 4.34 million and a habitat conditions, results in an of closed and partial seasons for this projected fall flight of 5.29 million allowable harvest in the United States of species in the future. pintails, the Pintail Harvest Strategy 467,900 birds for the 2007–08 season. Due to the relative lateness of this prescribes a full season and a 1-bird The expected canvasback harvest with a development, the generally earlier daily bag limit in all Flyways. Under the 1-bird daily bag limit for the entire opening of duck seasons in Alaska ‘‘liberal’’ season length, this regulation season is expected to be about 120,000 (September 1), and the anticipated level is expected to result in a harvest of birds. Available data indicates that of harvest in Alaska, we will exclude 569,000 pintails and an observed adding a second canvasback to the daily Alaska from the increase in the daily breeding population estimate of 3.24 bag limit is expected to increase harvest bag limit this year, as was recommended million in 2008, not considering any about 25 percent, or to approximately by the Pacific Flyway Council, with the potential effect from continuation of the 150,000 birds in the United States. The State of Alaska’s concurrence. However, Hunter’s Choice evaluation in the current harvest strategy has no we believe that Alaska should fully Central Flyway. provisions for daily bag limits greater engage in review of population Furthermore, we agree with the than one bird. However, with the record objectives and remain a part of the Central Flyway Council’s high breeding population recorded this overall harvest strategy for this species. recommendation to adopt a 39-day spring and the expected good Additionally, explicit provisions for ‘‘season-within-a-season’’ for pintails in recruitment, the strategy would project Alaska should be considered in any Colorado, Montana, Nebraska, New population growth even with a 2-bird proposed modifications to the strategy Mexico, and Oklahoma. We understand

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that this departure from the pintail combinations of Flyway-specific season the monitoring programs and databases strategy is a necessary part of the lengths and bag limits (http:// upon which scaup regulatory decisions experimental Hunter’s Choice season. www.fws.gov/migratorybirds/reports/ are based. These include: Evaluation of reports.html). A number of concerns potential biases in population estimates, vi. Scaup about the proposed strategy were raised expansion and improvement of Council Recommendations: The by the Flyway Councils and States. population surveys, and a feasibility Atlantic, Central, and Pacific Flyway In the July 23 Federal Register, we assessment of a broad-scale scaup Councils and the Upper- and Lower- addressed these concerns and stated banding program. Additionally, we will Region Regulations Committees of the that while we continue to support the continue retrospective analyses of Mississippi Flyway Council technical assessment of scaup harvest existing databases to assist in the recommended no changes in scaup potential, we were sensitive to the identification of causal factors which harvest regulations for 2007. All the concerns expressed by the Flyway might explain the continued scaup Flyway Councils reiterated their support Councils about the policy and social decline. for the cooperative development of a aspects of implementation of the In preparation for that dialogue, we comprehensive scaup harvest proposed strategy at this time. More reiterate our longstanding objections to management strategy. specifically, we agreed that more State-specific regulations and encourage Service Response: The continental dialogue about the nature of harvest the Flyway Councils to focus efforts on scaup (greater Aythya marila and lesser management objectives and regulatory achieving consensus around Flyway- Aythya affinis combined) population alternatives was necessary for successful wide regulatory alternatives. Secondly, has experienced a long-term decline implementation of the strategy. Failure we recognize that additional effort is over the past 20 years. Over the past to agree on crucial policy aspects of the necessary over the coming year to several years in particular, we have proposed strategy in a timely fashion communicate the rationale for a scaup continued to express our growing increases the risk that more drastic strategy and possible regulatory changes concern about the status of scaup. The regulatory measures may be necessary to the Flyways and the public. We 2007 breeding population estimate for in the future, and having considered all intend to review progress on policy scaup is 3.45 million, essentially of these concerns, we agreed that issues at the winter 2008 SRC meeting unchanged from the 2006 estimate, and another year is needed to develop and anticipate significant progress by the third lowest estimate on record. consensus on a harvest strategy for that time. Last year, we stated that we did not scaup. We believe that one year is vii. Mottled Ducks change scaup harvest regulations with sufficient time to resolve all outstanding the firm understanding that a draft issues and it is our intent to implement While we are not implementing any harvest strategy would be available for a strategy in 2008. However, we further changes in mottled duck hunting Flyway Council review prior to the stated that our decision did not regulations at this time, we remain winter meetings (71 FR 55654, preclude the possibility that we would concerned about mottled duck status, September 22, 2006) and be in place to consider possible changes to scaup especially those in the Western Gulf guide development of scaup hunting harvest regulations for the 2007–08 Coast region of Louisiana and Texas. regulations in 2007. As part of this hunting season, based on population However, we commend the progress effort, we developed an assessment status. made on the management of mottled framework that uses available data to We remain disappointed that ducks over the past year-and-a-half, help predict the effects of harvest and collectively we have not made the including the identification of two other uncontrollable environmental progress anticipated in the development management populations and work on factors on the scaup population. After of a viable strategy to manage harvest range-wide breeding surveys in Florida extensive review that we believe that acknowledges the uncertainty about and the Western Gulf Coast. We are resulted in substantial improvements, what factors are really influencing scaup committed to managing the Western the final technical assessment was numbers, but at the same time provides Gulf Coast as a single stock of birds, and presented during the Winter Flyway guidance on what changes in acknowledge the challenges that are Technical Section meetings and made regulations are still appropriate. associated with a population boundary available for public review in the April Although we remain very concerned that includes more than one Flyway. We 11 Federal Register. We stated then, and about the continued decline in scaup request that both the Central and continue to believe, that this technical numbers and other evidence that this Mississippi Flyways work together to assessment represents an objective and species is not doing well, we are not consider how a reduction in harvest, by comprehensive synthesis of data changing scaup regulations for the as much as 30 percent if necessary, can relevant to scaup harvest management 2007–08 hunting season. Our decision is be achieved with regulatory changes. and can help frame a scientifically- based on several important factors. First, We are confident that the Flyways will sound scaup harvest strategy. We note we believe that the hunting seasons be able to adequately address harvest that results of the assessment suggest provided herein are compatible with the management of mottled ducks as a that a reduction in scaup harvest is current status of scaup. Second, we have single Western Gulf Coast population commensurate with the current a firm understanding that a harvest unit, and we look forward to population status of scaup. Based on strategy will be available for 2008–09 considering a coordinated proposal this technical assessment, a proposed and that outstanding policy issues will during the 2008–09 regulatory cycle. scaup harvest strategy was made be resolved and incorporated into a final During the coming year, we will available for public review in the June strategy in time for adoption in June continue to explore methods to assess 8 Federal Register. The proposed 2008. And lastly, we believe that this mottled duck population status and harvest strategy included initial Service additional year of harvest strategy refine our understanding of population recommendations on a harvest development will not compromise our and harvest dynamics. management objective and proposed long term goals for scaup. We will work Further, we recognize that the mottled Flyway-specific harvest allocations, as with the Flyway Councils to resolve duck is an integral part of the Central well as an additional analysis that outstanding issues and to continue Flyway’s Hunter’s Choice bag-limit predicted scaup harvest from various ongoing cooperative efforts to improve experiment, and we support continued

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inclusion of the mottled duck among zones be adjusted to account for the county in the NW Oregon Permit Goose those species with a bag-limit restriction current harvest distribution of NAP and Zone, and establish a daily bag limit of in the experiment as requested by the resident Canada geese and to simplify dark geese of 3 including not more than Central Flyway Council. However, we zone boundaries. In Resident Population 2 cackling or Aleutian geese; and reiterate that if it is determined that (RP) areas, the Council recommended 4. Revise Idaho zone designations for further reductions in harvest, or a the allowance of an 80-day Canada 4 counties, to move all parts of Power different approach to harvest reduction, goose hunting season, with a 5-bird County from Zone 3 to Zone 5 and move are warranted at any time over the daily bag limit, and a 3-way split. In the Blaine and Camas Counties and Cassia course of the Hunter’s Choice RP harvest area of New York, they County within Minidoka National experiment, we will make those further recommend that the framework Wildlife Refuge from Zone 3 to Zone 4. necessary changes. Thus, the continued closing date be extended to March 10, Service Response: We concur with the implementation of this experiment will beginning this fall. They recommended Atlantic Flyway Council’s not preclude any future changes in reclassifying a small portion of the recommendations to adjust delineation hunting regulations that may be deemed Northeast Goose Hunt Zone in of High and Low NAP harvest zones in necessary on an annual basis for mottled Northampton County, North Carolina, to New York and Connecticut to account ducks. a Southern James Bay Population (SJBP) for the current harvest distribution of Hunt Zone designation. Lastly, they NAP. The Atlantic Flyway Management viii. Youth Hunt recommended that the SJBP Canada Plan for NAP Canada geese allows for a Council Recommendations: The goose harvest strategy be revised in the two-tiered approach to harvest Atlantic Flyway Council recommended SJBP Management Plan before changes management for this population. ‘‘High that tundra swans be added to the list to the SJBP harvest areas or season Harvest’’ zones are defined as those of eligible species legal to hunt during liberalization are considered in both areas within each State containing 70% special youth waterfowl hunts and that Flyways. or more of all NAP leg band recoveries, we allow the take of tundra swans The Upper- and Lower-Region whereas ‘‘Low Harvest’’ areas are all during the special youth waterfowl hunt Regulations Committees of the other areas of each State within existing day(s) to those individuals holding a Mississippi Flyway Council NAP zones. Use of High and Low valid permit/tag. Further, the Council recommended a number of changes in harvest zones allows States to increase recommended that this proposed take Canada goose zones, seasons lengths, and direct harvest opportunity towards occur regardless of whether the youth and bag limits for several States in the RP geese in areas where relatively few hunt day(s) are inside or outside the Flyway. These changes are an outgrowth NAP geese will be affected. current tundra swan hunting of the evolution of Canada goose harvest Under this revised delineation, New framework. management philosophy in the Flyway. York’s High and Low harvest zones Service Response: Currently, tundra The change in philosophy in the Flyway would contain approximately 83% and swans may be taken by individuals is driven by the increasing numbers of 17%, respectively, of all NAP band holding a valid permit/tag at any time giant Canada geese and the diminishing returns, still well within the during the open season without any importance of interior Canada geese to management plan criteria. In additional provisions. Since tundra goose harvest opportunities in the Connecticut, only 11% of all NAP swan harvests are tightly controlled in Flyway. The large numbers of giant recoveries have occurred in the NAP–L each State where a limited number of Canada geese in most States appear to zone since delineation (2002) of these permits are issued, we see no reason not be buffering, to some extent, hunting harvest zones, and no NAP recoveries to allow youth to harvest a tundra swan, pressure on interior Canada geese. have occurred in the proposed area of change. Both of these changes would as they will still have to possess a valid These changes will allow States to not only allow for more harvest of RP tag that is issued by random draw prior evaluate the potential of this buffering geese, but would have minimal impact to the hunting season. Further, we note effect as well as the impacts of stable regulations on interior Canada goose to NAP geese. that the revised (2007) Eastern We also concur with the Atlantic Population Tundra Swan Management populations. The Central Flyway Council Flyway Council’s recommendations plan advocates the issuance of tundra regarding frameworks for RP harvest swan hunt permits during youth recommended several changes for dark goose regulations. In the West Tier, they areas. Resident Canada geese are waterfowl days, regardless of whether overabundant in many areas of the these youth waterfowl hunting days are recommended an increase in season length (from 95 to 107 days) in Colorado Atlantic Flyway and currently number inside or outside the current framework. approximately 1.2 million birds, or Thus, we approve the addition of tundra and an increase in bag limit (from 3 to 4) in Colorado and Texas. In the East nearly double the goal in the Atlantic swans to the list of eligible species for Flyway Resident Canada Goose youth swan hunts and allowing the take Tier, they recommended removing the Big Stone Power Plant area restriction in Management Plan of 650,000 geese. of tundra swans inside or outside the Allowance of an 80-day season, tundra swan hunting frameworks. South Dakota. The Pacific Flyway Council combined with the 25-day special 4. Canada Geese recommended the following area, bag, Canada goose season in September, and the 2-day Youth Waterfowl Hunting B. Regular Seasons and season length changes described below: Days, would potentially allow 107 days Council Recommendations: The 1. Increase the bag limit to 6 geese per of harvest opportunity for RP geese, the Atlantic Flyway Council forwarded a day in the California Northeastern and maximum allowed under the Migratory number of recommendations concerning Balance-of-State Zones; Bird Treaty Act. Further, allowing 3- Canada geese. First, the Council 2. Increase the daily bag limit for way splits within the regular season recommended the approval of a minor small Canada geese in the California would provide States with greater change in the delineation of High and Balance-of-State Zone to 6 geese per flexibility for setting their seasons. All Low North Atlantic Population (NAP) day; of these objectives are consistent with harvest zones in New York. They further 3. Eliminate the closed zone of those identified in the Service’s 2005 recommended that Connecticut’s NAP Tillamook County, Oregon, include the Final Environmental Impact Statement

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on Resident Canada Goose Management Flyway Council believes that more will help address depredation concerns (70 FR 69985, November 18, 2005). dialogue is needed on these proposals in northwest California and southwest Since RP areas were first established in before they can support them. Given the Oregon associated with both of these 2002 (with 70-day seasons and a 5-bird lack of consensus between the two populations. The other changes daily limit), available band recovery Flyways, we do not support changes to proposed for Canada geese in data from the first 3 seasons (2002– SJBP regulations at this time. We Washington, Utah, and Nevada, are 2004) indicate that harvest of migrant encourage the two Flyways to revise the relatively minor boundary changes in geese (AP, NAP, and SJBP) has been SJBP management plan to reflect harvest zones or bag limit increases that negligible. Further, the March 10 closing evolving philosophies of Canada goose will help address depredation concerns date in New York will not adversely management in general. in these States and will not impact the impact AP geese migrating north in We concur with the Central Flyway’s harvest of other Canada goose early spring as data indicate that AP recommendation to increase the season populations of management concern in geese make only minimal use of the RP length from 95 to 107 days for dark the Flyway. The proposed zone area in New York. Lastly, delays in geese in Colorado and increase the daily boundary change in Idaho is an opening framework dates will be bag limit in Colorado and Texas. The administrative change and is not maintained to avoid any harvest of 2005–07 average (211,627) of mid- expected to have any measurable impact migrant geese during peak fall winter counts for the Hi-Line on the goose harvest from these areas. movements (e.g., early to mid October in Population of Canada geese remains C. Special Late Seasons New York) to southern regions of the well above the established objective Flyway. level (>85,000). Further, the 2005–07 Council Recommendations: The We also agree with the Atlantic average (200,821) of mid-winter counts Upper- and Lower-Region Regulations Flyway Council’s recommendation to for the Shortgrass Prairie Population of Committees of the Mississippi Flyway reclassify a small portion of the Canada geese also remains above the Council recommended a 3-year Northeast Goose Hunt Zone in established population objective experimental late Canada goose season Northampton County, North Carolina, to (150,000–200,000). Given the status of for a 30-county area in Indiana during an SJBP Hunt Zone designation. these populations and the established February 1–15. The 15-day season Northampton County currently includes population objective levels, we agree would be designed to increase harvests portions of two Canada goose hunt that the proposed increase in season of local giant Canada geese. zones—an AP zone designation and an length in Colorado and the daily bag Service Response: We concur with the SJBP zone designation. Over the last 15 limit increases in Colorado and Texas Council on the creation of an years, the AP zone in North Carolina has are commensurate with the status of the experimental late Canada goose season decreased in size due to contemporary populations. in Indiana. The 2007 population information regarding locations of Regarding the Central Flyway estimate for Mississippi Flyway Giant migrant Canada goose flocks and Council’s recommendation to remove Population Canada geese (MFGP) population affiliation. While the Big Stone Power Plant area breeding in Indiana is 125,000, and the Northampton County does hold migrant restriction in South Dakota, we agree. established population goal is 80,000. geese from both the AP and SJBP, the The restriction was put in place in 1997 While Indiana has used special Flyway’s original intent in including due to potential concerns related to the September Canada goose seasons to this small portion of Northampton status of Eastern Prairie Population control locally-breeding MFGP, County in the AP zone occurred at a (EPP) Canada geese. These geese nest in complaints regarding breeding MFGP in time when the AP population was the Hudson Bay Lowlands of Manitoba Indiana continue to increase. We agree reduced throughout the entire Flyway, and concentrate primarily in Manitoba, that a special late goose season could and when the Service’s and Flyway’s Minnesota, and Missouri during winter. help control Indiana’s breeding Canada goal was to provide maximum The 2007 spring estimate of EPP geese goose population. Available collar and protection to AP geese in North was 217,500, 17 percent higher than the harvest data indicate that the proposed Carolina. Since then, AP geese have 2006 estimate. Spring estimates have experimental area is comprised of well rebounded from low numbers in the late increased an average of 3 percent per above 80 percent non-migrant geese, as 1990s, and the hunting of AP geese in year over the last 10 years. Furthermore, required by the current criteria. North Carolina has been relaxed to some the estimated number of productive 6. Brant extent. geese in 2007 increased from 2006 and We do not agree with the framework reached a record-high level. We see no Council Recommendations: The changes and season liberalizations reason to continue this restriction. Atlantic Flyway Council recommends a proposed by the Mississippi Flyway We also concur with all of the 50-day season with a 2-bird daily bag Council to the SJBP harvest areas. SJBP recommendations forwarded by the limit for Atlantic brant. Canada geese are managed through a Pacific Flyway Council. We support the Service Response: We concur with the management plan developed changes proposed and recognize that the Atlantic Flyway Council cooperatively by the Atlantic and changes in California and Oregon are recommendation. The 2007 Mid-Winter Mississippi Flyways. In recent years, the intended to address increasing Index (MWI) for Atlantic brant was Mississippi Flyway has undergone depredation problems associated with 150,559. While the Brant Management major changes in their philosophical Aleutian Canada geese. Aleutian Canada Plan prescribes a 50-day season with a approach to Canada goose management. geese continue to increase rapidly and 2-bird daily bag limit when the MWI As a result, the Mississippi Flyway currently are above the population estimate falls within 125,000–150,000, Council has instituted changes in their objective levels identified in the Flyway and consideration of a 60-day season regulatory approach to MVP, SJBP, and management plan. We further note that with a 3-bird daily bag limit when the RP Canada goose management. While Pacific Flyway white-fronted geese and MWI estimate is above 150,000, the the Mississippi Flyway Council believes Aleutian Canada geese are at the highest outlook for productivity is below that their 2007–08 proposals for SJBP population levels that have been average due to highly variable regulations are consistent with the observed in the last 15 years. The conditions on the main breeding current management plan, the Atlantic proposed increased harvest opportunity grounds. Thus, we agree with the

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Council that an increase of 20 days that the regulations are not likely to and 2004. The primary source of (from last year’s 30-day season) without adversely affect any endangered or information about hunter expenditures the associated daily bag limit increase is threatened species. Additionally, these for migratory game bird hunting is the a conservative approach to harvest findings may have caused modification National Hunting and Fishing Survey, management for the upcoming season. of some regulatory measures previously which is conducted at 5-year intervals. proposed, and the final frameworks The 2004 Analysis was based on the National Environmental Policy Act reflect any such modifications. Our 2001 National Hunting and Fishing (NEPA) Consideration biological opinions resulting from this Survey and the U.S. Department of NEPA considerations are covered by section 7 consultation are public Commerce’s County Business Patterns, the programmatic document ‘‘Final documents available for public from which it was estimated that Supplemental Environmental Impact inspection at the address indicated migratory bird hunters would spend Statement: Issuance of Annual under ADDRESSES. between $481 million and $1.2 billion at Regulations Permitting the Sport small businesses in 2004. Copies of the Executive Order 12866 Hunting of Migratory Birds (FSES 88– Analysis are available upon request 14),’’ filed with the Environmental The migratory bird hunting from the address indicated under Protection Agency on June 9, 1988. We regulations are economically significant ADDRESSES or from our Web site at published a Notice of Availability in the and were reviewed by the Office of http://www.fws.gov/migratorybirds/ Federal Register on June 16, 1988 (53 Management and Budget (OMB) under reports/SpecialTopics/ FR 22582). We published our Record of Executive Order 12866. As such, a cost/ EconomicAnalysis-Final-2004.pdf. Decision on August 18, 1988 (53 FR benefit analysis was initially prepared This year, due to limited data 31341). Annual NEPA considerations in 1981. This analysis was subsequently availability, we partially updated the are covered under a separate revised annually from 1990–96, updated 2004 analysis, but restricted our Environmental Assessment (EA), ‘‘Duck in 1998, and updated again in 2004. It analysis to duck hunting. Results Hunting Regulations for 2007–08,’’ and is further discussed below under the indicate that the duck hunters would an August 27, 2007, Finding of No heading Regulatory Flexibility Act. spend between $291 million and $473.5 Significant Impact (FONSI). Copies of Results from the 2004 analysis indicate million at small businesses in 2007. We the EA and FONSI are available upon that the expected welfare benefit of the plan to perform a full update of the request from the address indicated annual migratory bird hunting analysis in 2008 when the full results under ADDRESSES. frameworks is on the order of $734 from the 2006 National Hunting and In a notice published in the million to $1.064 billion, with a mid- Fishing Survey is available. Copies of September 8, 2005, Federal Register (70 point estimate of $899 million. Copies the updated analysis are available upon FR 53376), we announced our intent to of the cost/benefit analysis are available request from the address indicated develop a new Supplemental upon request from the address indicated under ADDRESSES or from our Web site Environmental Impact Statement for the under ADDRESSES or from our Web site at http://www.fws.gov/migratorybirds/ migratory bird hunting program. Public at http://www.fws.gov/migratorybirds/ reports/SpecialTopics/ scoping meetings were held in the reports/SpecialTopics/ EconomicAnalysis-2007Update.pdf. spring of 2006, as we announced in a EconomicAnalysis-Final-2004.pdf. March 9, 2006, Federal Register notice This year, due to limited data Small Business Regulatory Enforcement (71 FR 12216). A scoping report availability, we partially updated the Fairness Act summarizing the scoping comments and 2004 analysis, but restricted our This rule is a major rule under 5 scoping meetings is available either at analysis to duck hunting. Results U.S.C. 804(2), the Small Business the address indicated under ADDRESSES indicate that the total consumer surplus Regulatory Enforcement Fairness Act. or on our Web site at http:// of the annual duck hunting frameworks For the reasons outlined above, this rule www.fws.gov/migratorybirds. is on the order of $222 to $360 million, has an annual effect on the economy of with a mid-point estimate of $291 $100 million or more. However, because Endangered Species Act Consideration million. We plan to perform a full this rule establishes hunting seasons, we Section 7 of the Endangered Species update of the analysis in 2008. Copies do not plan to defer the effective date Act, as amended (16 U.S.C. 1531–1543; of the updated analysis are available under the exemption contained in 5 87 Stat. 884), provides that, ‘‘The upon request from the address indicated U.S.C. 808(1). Secretary shall review other programs under ADDRESSES or from our Web site Paperwork Reduction Act administered by him and utilize such at http://www.fws.gov/migratorybirds/ programs in furtherance of the purposes reports/SpecialTopics/ We examined these regulations under of this Act’’ (and) shall ‘‘insure that any EconomicAnalysis-2007Update.pdf. the Paperwork Reduction Act of 1995 action authorized, funded, or carried out (PRA). There are no new information * * * is not likely to jeopardize the Regulatory Flexibility Act collections in this rule that would continued existence of any endangered These regulations have a significant require OMB approval under the PRA. species or threatened species or result in economic impact on substantial The existing various recordkeeping and the destruction or adverse modification numbers of small entities under the reporting requirements imposed under of [critical] habitat * * *.’’ Regulatory Flexibility Act (5 U.S.C. 601 regulations established in 50 CFR part Consequently, we conducted formal et seq.). We analyzed the economic 20, Subpart K, are utilized in the consultations to ensure that actions impacts of the annual hunting formulation of migratory game bird resulting from these regulations would regulations on small business entities in hunting regulations. Specifically, OMB not likely jeopardize the continued detail as part of the 1981 cost-benefit has approved the information collection existence of endangered or threatened analysis discussed under Executive requirements of the surveys associated species or result in the destruction or Order 12866. This analysis was revised with the Migratory Bird Harvest adverse modification of their critical annually from 1990–95. In 1995, the Information Program and assigned habitat. Findings from these Service issued a Small Entity Flexibility clearance number 1018–0015 (expires 2/ consultations are included in a Analysis (Analysis), which was 29/2008). This information is used to biological opinion, which concluded subsequently updated in 1996, 1998, provide a sampling frame for voluntary

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national surveys to improve our harvest Migratory Bird Treaty Act. Thus, in believed were the longest periods estimates for all migratory game birds in accordance with the President’s possible for public comment. In doing order to better manage these memorandum of April 29, 1994, this, we recognized that when the populations. ‘‘Government-to-Government Relations comment period closed, time would be A Federal agency may not conduct or with Native American Tribal of the essence. That is, if there were a sponsor, and a person is not required to Governments’’ (59 FR 22951), Executive delay in the effective date of these respond to, a collection of information Order 13175, and 512 DM 2, we have regulations after this final rulemaking, unless it displays a currently valid OMB evaluated possible effects on Federally States would have insufficient time to control number. recognized Indian tribes and have select season dates and limits; to determined that there are no effects on communicate those selections to us; and Unfunded Mandates Reform Act Indian trust resources. However, in the to establish and publicize the necessary We have determined and certify, in April 11 proposed rule we solicited regulations and procedures to compliance with the requirements of the proposals for special migratory bird implement their decisions. We therefore Unfunded Mandates Reform Act, 2 hunting regulations for certain Tribes on find that ‘‘good cause’’ exists, within the U.S.C. 1502 et seq., that this rulemaking Federal Indian reservations, off- terms of 5 U.S.C. 553(d)(3) of the will not impose a cost of $100 million reservation trust lands, and ceded lands Administrative Procedure Act, and or more in any given year on local or for the 2007–08 migratory bird hunting these frameworks will, therefore, take State government or private entities. season. The resulting proposals were effect immediately upon publication. Therefore, this rule is not a ‘‘significant contained in a separate rulemaking. By Therefore, under authority of the regulatory action’’ under the Unfunded virtue of these actions, we have Migratory Bird Treaty Act (July 3, 1918), Mandates Reform Act. consulted with all the Tribes affected by as amended (16 U.S.C. 703–711), we this rule. prescribe final frameworks setting forth Civil Justice Reform—Executive Order the species to be hunted, the daily bag 12988 Federalism Effects and possession limits, the shooting The Department, in promulgating this Due to the migratory nature of certain hours, the season lengths, the earliest rule, has determined that this rule will species of birds, the Federal opening and latest closing season dates, not unduly burden the judicial system Government has been given and hunting areas, from which State and that it meets the requirements of responsibility over these species by the conservation agency officials will select sections 3(a) and 3(b)(2) of Executive Migratory Bird Treaty Act. We annually hunting season dates and other options. Order 12988. prescribe frameworks from which the Upon receipt of selections, we will States make selections regarding the publish in the Federal Register a final Takings Implication Assessment hunting of migratory birds, and we rulemaking amending 50 CFR part 20 to In accordance with Executive Order employ guidelines to establish special reflect seasons, limits, and shooting 12630, this rule, authorized by the regulations on Federal Indian hours for the conterminous United Migratory Bird Treaty Act, does not reservations and ceded lands. This States for the 2007–08 hunting season. have significant takings implications process preserves the ability of the and does not affect any constitutionally States and tribes to determine which List of Subjects in 50 CFR Part 20 protected property rights. This rule will seasons meet their individual needs. Exports, Hunting, Imports, Reporting not result in the physical occupancy of Any State or Indian tribe may be more and recordkeeping requirements, property, the physical invasion of restrictive than the Federal frameworks Transportation, Wildlife. property, or the regulatory taking of any at any time. The frameworks are The rules that eventually will be property. In fact, these rules allow developed in a cooperative process with promulgated for the 2007–08 hunting hunters to exercise otherwise the States and the Flyway Councils. season are authorized under 16 U.S.C. unavailable privileges and, therefore, This process allows States to participate 703–712 and 16 U.S.C. 742 a–j. reduce restrictions on the use of private in the development of frameworks from Dated: September 14, 2007. and public property. which they will make selections, David M. Verhey, thereby having an influence on their Energy Effects—Executive Order 13211 Acting Assistant Secretary for Fish and own regulations. These rules do not Wildlife and Parks. On May 18, 2001, the President issued have a substantial direct effect on fiscal Executive Order 13211 on regulations capacity, change the roles or PART 20—[AMENDED] that significantly affect energy supply, responsibilities of Federal or State distribution, and use. Executive Order governments, or intrude on State policy Final Regulations Frameworks for 13211 requires agencies to prepare or administration. Therefore, in 2007–08 Late Hunting Seasons on Statements of Energy Effects when accordance with Executive Order 13132, Certain Migratory Game Birds undertaking certain actions. While this these regulations do not have significant Pursuant to the Migratory Bird Treaty rule is a significant regulatory action federalism effects and do not have Act and delegated authorities, the under Executive Order 12866, it is not sufficient federalism implications to Department has approved the following expected to adversely affect energy warrant the preparation of a Federalism frameworks for season lengths, shooting supplies, distribution, or use. Therefore, Assessment. hours, bag and possession limits, and this action is not a significant energy Regulations Promulgation outside dates within which States may action and no Statement of Energy select seasons for hunting waterfowl Effects is required. The rulemaking process for migratory and coots between the dates of game bird hunting must, by its nature, September 1, 2007, and March 10, 2008. Government-to-Government operate under severe time constraints. Relationship With Tribes However, we intend that the public be General Due to the migratory nature of certain given the greatest possible opportunity Dates: All outside dates noted below species of birds, the Federal to comment. Thus, when the are inclusive. Government has been given preliminary proposed rulemaking was Shooting and Hawking (taking by responsibility over these species by the published, we established what we falconry) Hours: Unless otherwise

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specified, from one-half hour before North Carolina, Pennsylvania, and regular duck season daily bag (not to sunrise to sunset daily. Virginia, where Sunday hunting is exceed 4 scoters) and possession limits. Possession Limits: Unless otherwise prohibited statewide by State law, all Merganser Limits: The daily bag limit specified, possession limits are twice Sundays are closed to all take of of mergansers is 5, only 2 of which may the daily bag limit. migratory waterfowl (including be hooded mergansers. In States that mergansers and coots). include mergansers in the duck bag Flyways and Management Units limit, the daily limit is the same as the Special Youth Waterfowl Hunting Days Waterfowl Flyways duck bag limit, only two of which may Outside Dates: States may select two be hooded mergansers. Atlantic Flyway—includes consecutive days (hunting days in Coot Limits: The daily bag limit is 15 Connecticut, Delaware, Florida, Georgia, Atlantic Flyway States with coots. Maine, Maryland, Massachusetts, New compensatory days) per duck-hunting Lake Champlain Zone, New York: The Hampshire, New Jersey, New York, zone, designated as ‘‘Youth Waterfowl waterfowl seasons, limits, and shooting North Carolina, Pennsylvania, Rhode Hunting Days,’’ in addition to their hours shall be the same as those Island, South Carolina, Vermont, regular duck seasons. The days must be selected for the Lake Champlain Zone of Virginia, and West Virginia. held outside any regular duck season on Vermont. Mississippi Flyway—includes a weekend, holiday, or other non-school Connecticut River Zone, Vermont: Alabama, Arkansas, Illinois, Indiana, day when youth hunters would have the The waterfowl seasons, limits, and Iowa, Kentucky, Louisiana, Michigan, maximum opportunity to participate. shooting hours shall be the same as Minnesota, Mississippi, Missouri, Ohio, The days may be held up to 14 days those selected for the Inland Zone of Tennessee, and Wisconsin. before or after any regular duck-season New Hampshire. Central Flyway—includes Colorado frameworks or within any split of a Zoning and Split Seasons: Delaware, (east of the Continental Divide), Kansas, regular duck season, or within any other Florida, Georgia, Maryland, North Montana (Counties of Blaine, Carbon, open season on migratory birds. Carolina, Rhode Island, South Carolina, Fergus, Judith Basin, Stillwater, Daily Bag Limits: The daily bag limits and Virginia may split their seasons into Sweetgrass, Wheatland, and all counties may include ducks, geese, tundra three segments; Connecticut, Maine, east thereof), Nebraska, New Mexico swans, mergansers, coots, moorhens, Massachusetts, New Hampshire, New (east of the Continental Divide except and gallinules and would be the same Jersey, New York, Pennsylvania, the Jicarilla Apache Indian Reservation), as those allowed in the regular season. Vermont, and West Virginia may select North Dakota, Oklahoma, South Dakota, Flyway species and area restrictions hunting seasons by zones and may split Texas, and Wyoming (east of the would remain in effect. their seasons into two segments in each Continental Divide). Shooting Hours: One-half hour before zone. Pacific Flyway—includes Alaska, sunrise to sunset. Canada Geese Arizona, California, Idaho, Nevada, Participation Restrictions: Youth Oregon, Utah, Washington, and those hunters must be 15 years of age or Season Lengths, Outside Dates, and portions of Colorado, Montana, New younger. In addition, an adult at least 18 Limits: Specific regulations for Canada Mexico, and Wyoming not included in years of age must accompany the youth geese are shown below by State. These the Central Flyway. hunter into the field. This adult may not seasons also include white-fronted Management Units duck hunt but may participate in other geese. Unless specified otherwise, seasons that are open on the special seasons may be split into two segments. High Plains Mallard Management youth day. Tundra swans may only be In areas within States where the Unit—roughly defined as that portion of taken by participants possessing framework closing date for Atlantic the Central Flyway that lies west of the applicable tundra swan permits. Population (AP) goose seasons overlaps 100th meridian. with special late-season frameworks for Definitions: For the purpose of Atlantic Flyway resident geese, the framework closing hunting regulations listed below, the Ducks, Mergansers, and Coots date for AP goose seasons is January 14. collective terms ‘‘dark’’ and ‘‘light’’ geese include the following species: Outside Dates: Between the Saturday Connecticut Dark geese: Canada geese, white- nearest September 24 (September 22) North Atlantic Population (NAP) fronted geese, brant (except in and the last Sunday in January (January Zone: Between October 1 and January California, Oregon, Washington, and the 27). 31, a 60-day season may be held with Atlantic Flyway), and all other goose Hunting Seasons and Duck Limits: 60 a 2-bird daily bag limit in the H Unit; species except light geese. days. The daily bag limit is 6 ducks, and between October 1 and February 15, Light geese: snow (including blue) including no more than 4 mallards (2 a 70-day season with a 3-bird daily bag geese and Ross’ geese. hens), 2 scaup, 1 black duck, 1 pintail, in the L Unit. Area, Zone, and Unit Descriptions: 2 canvasbacks, 1 mottled duck, 1 Atlantic Population (AP) Zone: A 45- Geographic descriptions related to late- fulvous whistling duck, 2 wood ducks, day season may be held between the season regulations are contained in a 2 redheads, and 4 scoters. fourth Saturday in October (October 27) later portion of this document. Closures: The season on harlequin and January 31, with a 3-bird daily bag Area-Specific Provisions: Frameworks ducks is closed. limit. for open seasons, season lengths, bag Sea Ducks: Within the special sea South Zone: A special season may be and possession limits, and other special duck areas, during the regular duck held between January 15 and February provisions are listed below by Flyway. season in the Atlantic Flyway, States 15, with a 5-bird daily bag limit. may choose to allow the above sea duck Delaware: A 45-day season may be Waterfowl Seasons in the Atlantic limits in addition to the limits applying held between November 15 and January Flyway to other ducks during the regular duck 31, with a 2-bird daily bag limit. In the Atlantic Flyway States of season. In all other areas, sea ducks may Florida: An 80-day season may be Connecticut, Delaware, Maine, be taken only during the regular open held between November 15 and Maryland, Massachusetts, New Jersey, season for ducks and are part of the February 15, with a 5-bird daily bag

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limit. The season may be split into 3 RP Zone: An 80-day season may be Virginia segments. held between the fourth Saturday in SJBP Zone: A 40-day season may be Georgia: In specific areas, an 80-day October (October 27) and March 10, held between November 15 and January season may be held between November with a 5-bird daily bag limit. The season 14, with a 2-bird daily bag limit. 15 and February 15, with a 5-bird daily may be split into 3 segments. Additionally, an experimental season bag limit. The season may be split into North Carolina may be held between January 15 and 3 segments. February 15, with a 5-bird daily bag Maine: A 60-day season may be held SJBP Zone: A 70-day season may be limit. Statewide between October 1 and held between October 1 and December AP Zone: A 45-day season may be January 31, with a 2-bird daily bag limit. 31, with a 2-bird daily bag limit. held between November 15 and January Maryland RP Zone: An 80-day season may be 31, with a 2-bird daily bag limit. held between October 1 and February RP Zone: An 80-day season may be Resident Population (RP) Zone: An 15, with a 5-bird daily bag limit. The held between November 15 and 80-day season may be held between season may be split into 3 segments. February 15, with a 5-bird daily bag November 15 and February 15, with a 5- limit. The season may be split into 3 bird daily bag limit. The season may be Northeast Hunt Unit: A 30-day segments. split into 3 segments. experimental season (1,000 permits) Back Bay Area: A 30-day AP Zone: A 45-day season may be may be held concurrent with the season experimental season may be held held between November 15 and January selected for the Back Bay Area of between December 24 and January 26 in 31, with a 2-bird daily bag limit. Virginia. The seasonal bag limit is 1 bird. the AP Zone, with a 2-bird daily bag Massachusetts limit. Pennsylvania NAP Zone: A 60-day season may be West Virginia held between October 1 and January 31, SJBP Zone: A 70-day season may be An 80-day season may be held with a 2-bird daily bag limit. held between the second Saturday in between October 1 and January 31, with Additionally, a special season may be October (October 13) and February 15, a 5-bird daily bag limit. The season may held from January 15 to February 15, with a 2-bird daily bag limit until be split into 3 segments. with a 5-bird daily bag limit. January 14 and a 5-bird daily bag limit AP Zone: A 45-day season may be between January 15 and February 15. Light Geese held between October 20 and January Pymatuning Zone: A 50-day season Season Lengths, Outside Dates, and 31, with a 3-bird daily bag limit. may be held between October 1 and Limits: States may select a 107-day January 31, with a 2-bird daily bag limit. New Hampshire season between October 1 and March RP Zone: An 80-day season may be 10, with a 15-bird daily bag limit and no A 60-day season may be held held between November 15 and possession limit. States may split their statewide between October 1 and February 15, with a 5-bird daily bag seasons into three segments, except in January 31, with a 2-bird daily bag limit. limit. The season may be split into 3 Delaware and Maryland, where, New Jersey segments. following the completion of their duck AP Zone: A 45-day season may be Statewide: A 45-day season may be season, and until March 10, Delaware held between the fourth Saturday in held between the fourth Saturday in and Maryland may split the remaining October (October 27) and January 31, October (October 27) and January 31, portion of the season to allow hunting with a 3-bird daily bag limit. with a 3-bird daily bag limit. on Mondays, Wednesdays, Fridays, and Special Late Goose Season Area: An Special Late Goose Season Area: An Saturdays only. experimental season may be held from experimental season may be held in Brant designated areas of North and South January 15 to February 15, with a 5-bird New Jersey from January 15 to February daily bag limit. Season Lengths, Outside Dates, and Limits: States may select a 50-day 15, with a 5-bird daily bag limit. Rhode Island New York season between the Saturday nearest NAP Zone: Between October 1 and A 60-day season may be held between September 24 (September 22) and January 31, a 60-day season may be October 1 and January 31, with a 2-bird January 31, with a 2-bird daily bag limit. held, with a 2-bird daily bag limit in the daily bag limit. An experimental season States may split their seasons into two High Harvest areas; and between may be held in designated areas from segments. October 1 and February 15, a 70-day January 15 to February 15, with a 5-bird Mississippi Flyway season may be held, with a 3-bird daily daily bag limit. Ducks, Mergansers, and Coots bag limit in the Low Harvest areas. South Carolina Special Late Goose Season Area: An Outside Dates: Between the Saturday experimental season may be held In designated areas, an 80-day season nearest September 24 (September 22) between January 15 and February 15, may be held during November 15 to and the last Sunday in January (January with a 5-bird daily bag limit in February 15, with a 5-bird daily bag 27). designated areas of Chemung, Delaware, limit. The season may be split into 3 Hunting Seasons and Duck Limits: Tioga, Broome, Sullivan, Westchester, segments. The season may not exceed 60 days, Nassau, Suffolk, Orange, Dutchess, Vermont with a daily bag limit of 6 ducks, Putnam, and Rockland Counties. including no more than 4 mallards (no AP Zone: A 45-day season may be A 45-day season may be held between more than 2 of which may be females), held between the fourth Saturday in the fourth Saturday in October (October 3 mottled ducks, 2 scaup, 1 black duck, October (October 27), except in the Lake 27), except in the Lake Champlain Zone 1 pintail, 2 canvasbacks, 2 wood ducks, Champlain Area where the opening date and Interior Zone where the opening and 2 redheads. is October 20, and January 31, with a 3- date is October 20, and January 31, with Merganser Limits: The daily bag limit bird daily bag limit. a 3-bird daily bag limit. is 5, only 2 of which may be hooded

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mergansers. In States that include Zone. The daily bag limit is 2 Canada (2) Tuscola/Huron GMU—The Canada mergansers in the duck bag limit, the geese. goose season will close after 50 days or daily limit is the same as the duck bag when 750 birds have been harvested, Indiana limit, only 2 of which may be hooded whichever occurs first. The daily bag mergansers. The season for Canada geese may limit is 1 Canada goose. Coot Limits: The daily bag limit is 15 extend for 74 days, except in the SJBP (c) Southern Michigan Late Season coots. Zone, where the season may not exceed Canada Goose Zone—A 30-day special Zoning and Split Seasons: Alabama, 50 days. The daily bag limit is 2 Canada Canada goose season may be held Illinois, Indiana, Iowa, Kentucky, geese. between December 31 and February 7. Louisiana, Michigan, Minnesota, Late Canada Goose Season Zone-—n The daily bag limit may not exceed 5 Missouri, Ohio, Tennessee, and experimental special Canada goose Canada geese. season of up to 15 days may be held Wisconsin may select hunting seasons Minnesota by zones. during February 1–15. During this In Alabama, Indiana, Iowa, Kentucky, special season the daily bag limit cannot (a) West Zone Louisiana, Michigan, Minnesota, Ohio, exceed 5 Canada geese. (1) West Central Zone—The season for Canada geese may extend for 41 days. Tennessee, and Wisconsin, the season Iowa may be split into two segments in each The daily bag limit is 2 Canada geese. The season for Canada geese may zone. (2) Remainder of West Zone—The extend for 90 days. The daily bag limit season for Canada geese may extend for In Arkansas and Mississippi, the is 2 Canada geese. 60 days. The daily bag limit is 2 Canada season may be split into three segments. Kentucky geese. Geese (b) Remainder of the State—The (a) Western Zone—The season for season for Canada geese may extend for Split Seasons: Seasons for geese may Canada geese may extend for 70 days 70 days. The daily bag limit is 2 Canada be split into three segments. (85 days in Fulton County). The season geese. Season Lengths, Outside Dates, and in Fulton County may extend to (c) Special Late Canada Goose Limits: States may select seasons for February 15. The daily bag limit is 2 Season—A special Canada goose season light geese not to exceed 107 days, with Canada geese. of up to 10 days may be held in 20 geese daily between the Saturday (b) Pennyroyal/Coalfield Zone—The December, except in the West Central nearest September 24 (September 22) season may extend for 50 days. The Goose zone. During the special season, and March 10; for white-fronted geese daily bag limit is 2 Canada geese. the daily bag limit is 5 Canada geese, not to exceed 72 days with 2 geese daily (c) Remainder of the State—The except in the Southeast Goose Zone, or 86 days with 1 goose daily between season may extend for 50 days. The where the daily bag limit is 2. the Saturday nearest September 24 daily bag limit is 2 Canada geese. (September 22) and the Sunday nearest Mississippi Louisiana February 15 (February 17); and for brant The season for Canada geese may not to exceed 70 days, with 2 brant daily The season for Canada geese may extend for 70 days. The daily BAG limit or 107 days with 1 brant daily between extend for 16 days. During the season, is 3 Canada geese. the Saturday nearest September 24 the daily bag limit is 1 Canada goose (September 22) and January 31. There is and 2 white-fronted geese with a 72-day Missouri no possession limit for light geese. white-fronted goose season or 1 white- The season for Canada geese may Specific regulations for Canada geese fronted goose with an 86-day season. extend for 79 days and may be split into and exceptions to the above general Hunters participating in the Canada 3 segments provided that at least 1 provisions are shown below by State. goose season must possess a special segment of at least 9 days occurs prior Except as noted below, the outside dates permit issued by the State. to October 16. The daily bag limit is 3 for Canada geese are the Saturday Michigan Canada geese through October 15 and 2 nearest September 24 (September 22) Canada geese thereafter. and January 31. (a) MVP—Upper and Lower Peninsula Zones—The framework opening date for Ohio Alabama all geese is September 16 and the season The season for Canada geese may In the SJBP Goose Zone, the season for Canada geese may extend for 45 extend for 60 days in the respective for Canada geese may not exceed 50 days. The daily bag limit is 2 Canada duck-hunting zones, with a daily bag days. Elsewhere, the season for Canada geese. limit of 2 Canada geese, except in the geese may extend for 70 days in the (1) Allegan County GMU—The Lake Erie SJBP Zone, where the season respective duck-hunting zones. The Canada goose season is 45 days. The may not exceed 40 days and the daily daily bag limit is 2 Canada geese. daily bag limit is 2 Canada geese. bag limit is 2 Canada geese. A special (2) Muskegon Wastewater GMU—The Arkansas Canada goose season of up to 22 days, Canada goose season is 45 days. The beginning the first Saturday after In the Northwest Zone, the season for daily bag limit is 2 Canada geese. January 10, may be held in the following Canada geese may extend for 50 days. In (b) SJBP Zone—The framework Counties: Allen (north of U.S. Highway the remainder of the State, the season opening date for all geese is September 30), Fulton, Geauga (north of Route 6), may not exceed 40 days. The season 16 and the season for Canada geese may Henry, Huron, Lucas (Lake Erie Zone may extend to February 15. The daily extend for 30 days. The daily bag limit closed), Seneca, and Summit (Lake Erie bag limit is 2 Canada geese. is 2 Canada geese. Zone closed). During the special season, (1) Saginaw County GMU—The Illinois the daily bag limit is 2 Canada geese. Canada goose season will close after 50 The season for Canada geese may days or when 2,000 birds have been Tennessee extend for 85 days in the North and harvested, whichever occurs first. The (a) Northwest Zone—The season for Central Zones and 66 days in the South daily bag limit is 1 Canada goose. Canada geese may not exceed 72 days,

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and may extend to February 15. The each State. A single canvasback and and the Eastern Goose Zone of Texas, daily bag limit is 2 Canada geese. pintail may also be included in the 6- States may select a season for Canada (b) Southwest Zone—The season for bird daily bag limit for designated geese (or any other dark goose species Canada geese may extend for 72 days. youth-hunt days. except white-fronted geese) not to The daily bag limit is 2 Canada geese. (2) Kansas, North Dakota, South exceed 107 days with a daily bag limit (c) Kentucky/Barkley Lakes Zone— Dakota, Texas, and Wyoming: The daily of 3. Additionally, in the Eastern Goose The season for Canada geese may extend bag limit is 5 ducks, with species and Zone of Texas, an alternative season of for 59 days, at least 9 of which must sex restrictions as follows: 2 scaup, 2 107 days with a daily bag limit of 1 occur before Oct. 16. The daily bag limit redheads, and 2 wood ducks, and only Canada goose may be selected. For is 2 Canada geese. 1 duck from the following group—hen white-fronted geese, these States may (d) Remainder of the State—The mallard, mottled duck, pintail, select either a season of 72 days with a season for Canada geese may extend for canvasback. bag limit of 2 or a 86-day season with 72 days. The daily bag limit is 2 Canada Merganser Limits: The daily bag limit a bag limit of 1. geese. is 5 mergansers, only 2 of which may be In Montana, New Mexico and Wisconsin hooded mergansers. In States that include mergansers in the duck daily Wyoming, States may select seasons not (a) Horicon Zone—The framework bag limit, the daily limit may be the to exceed 107 days. The daily bag limit opening date for all geese is September same as the duck bag limit, only two of for dark geese is 5 in the aggregate. 16. The season may not exceed 92 days. which may be hooded mergansers. In Colorado, the season may not All Canada geese harvested must be Coot Limits: The daily bag limit is 15 exceed 107 days. The daily bag limit is tagged. The season limit will be 6 coots. 4 dark geese in the aggregate. Canada geese per permittee. Zoning and Split Seasons: Kansas (b) Collins Zone—The framework In the Western Goose Zone of Texas, (Low Plains portion), Montana, the season may not exceed 95 days. The opening date for all geese is September Nebraska (Low Plains portion), New 16. The season may not exceed 70 days. daily bag limit for Canada geese (or any Mexico, Oklahoma (Low Plains portion), other dark goose species except white- All Canada geese harvested must be South Dakota (Low Plains portion), tagged. The season limit will be 6 fronted geese) is 4. The daily bag limit Texas (Low Plains portion), and for white-fronted geese is 1. Canada geese per permittee. Wyoming may select hunting seasons by (c) Exterior Zone—The framework zones. Pacific Flyway opening date for all geese is September In Kansas, Montana, Nebraska, New 16. The season may not exceed 85 days. Mexico, North Dakota, Oklahoma, South Ducks, Mergansers, Coots, Common The daily bag limit is 2 Canada geese. Dakota, Texas, and Wyoming, the Moorhens, and Purple Gallinules Additional Limits: In addition to the regular season may be split into two Hunting Seasons and Duck Limits: harvest limits stated for the respective segments. zones above, an additional 4,500 Canada Concurrent 107 days. The daily bag In Colorado, the season may be split limit is 7 ducks and mergansers, geese may be taken in the Horicon Zone into three segments. under special agricultural permits. including no more than 2 female Geese mallards, 1 pintail, 2 canvasbacks, 3 Central Flyway Split Seasons: Seasons for geese may scaup, and 2 redheads. Ducks, Mergansers, and Coots be split into three segments. Three-way The season on coots and common Outside Dates: Between the Saturday split seasons for Canada geese require moorhens may be between the outside nearest September 24 (September 22) Central Flyway Council and U.S. Fish dates for the season on ducks, but not and the last Sunday in January (January and Wildlife Service approval, and a 3- to exceed 107 days. 27). year evaluation by each participating Coot, Common Moorhen, and Purple State. Hunting Seasons Gallinule Limits: The daily bag and Outside Dates: For dark geese, seasons possession limits of coots, common (1) High Plains Mallard Management may be selected between the outside moorhens, and purple gallinules are 25, Unit (roughly defined as that portion of dates of the Saturday nearest September singly or in the aggregate. the Central Flyway which lies west of 24 (September 22) and the Sunday the 100th meridian): 97 days. The last nearest February 15 (February 17). For Outside Dates: Between the Saturday 23 days may start no earlier than the light geese, outside dates for seasons nearest September 24 (September 22) Saturday nearest December 10 may be selected between the Saturday and the last Sunday in January (January (December 8). nearest September 24 (September 22) 27). (2) Remainder of the Central Flyway: and March 10. In the Rainwater Basin Zoning and Split Seasons: Arizona, 74 days. Light Goose Area (East and West) of California, Idaho, Nevada, Oregon, Utah, Nebraska, temporal and spatial Bag Limits Washington, and Wyoming may select restrictions that are consistent with the hunting seasons by zones. Arizona, (1) Colorado, Montana, Nebraska, late-winter snow goose hunting strategy California, Idaho, Nevada, Oregon, Utah, New Mexico, and Oklahoma: The daily cooperatively developed by the Central Washington, and Wyoming may split bag limit is 6 ducks, with species and Flyway Council and the Service are their seasons into two segments. sex restrictions as follows: 5 mallards required. (no more than 2 of which may be Colorado, Montana, and New Mexico females), 2 redheads, 2 scaup, 2 wood Season Lengths and Limits may split their seasons into three ducks, 1 pintail, 1 mottled duck, and 1 Light Geese: States may select a light segments. canvasback. For pintails and goose season not to exceed 107 days. Colorado River Zone, California: canvasbacks, the season length would The daily bag limit for light geese is 20 Seasons and limits shall be the same as be 39 days, which may be split with no possession limit. seasons and limits selected in the according to applicable zones/split duck Dark Geese: In Kansas, Nebraska, adjacent portion of Arizona (South hunting configurations approved for North Dakota, Oklahoma, South Dakota, Zone).

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Geese day including 6 cackling Canada geese Quota Zones or 6 Aleutian Canada geese. In the Season Lengths, Outside Dates, and Seasons on dark geese must end upon Sacramento Valley Special Management Limits attainment of individual quotas of Area (West), the season on white- dusky geese allotted to the designated California, Oregon, and Washington: fronted geese must begin no earlier than areas of Oregon and Washington. The Except as subsequently noted, 100-day the last Saturday in October and end on September Canada goose season, the seasons may be selected, with outside or before December 14, and the daily regular goose season, any special late dates between the Saturday nearest bag limit shall contain no more than 2 dark goose season, and any extended October 1 (September 29), and the last white-fronted geese. falconry season, combined, must not Sunday in January (January 27). Basic Oregon: Except as subsequently exceed 107 days, and the established daily bag limits are 4 light geese and 4 noted, the dark goose daily bag limit is quota of dusky geese must not be dark geese, except in California, Oregon, 4, including not more than 1 cackling or exceeded. Hunting of dark geese in and Washington, where the dark goose Aleutian goose. those designated areas will only be by bag limit does not include brant. In Oregon’s South Coast Zone and Harney, Lake, and Malheur County hunters possessing a State-issued permit California’s North Coast Special Zone: For Lake County only, the daily authorizing them to do so. In a Service- Management Area, 107-day seasons may dark goose bag limit may not include approved investigation, the State must be selected, with outside dates between more than 2 white-fronted geese. obtain quantitative information on the Saturday nearest October 1 Klamath County Zone: A 107-day hunter compliance of those regulations (September 29) and March 10. Hunting season may be selected, with outside aimed at reducing the take of dusky days that occur after the last Sunday in dates between the Saturday nearest geese. If the monitoring program cannot January shall be concurrent in both October 1 (September 29), and March be conducted, for any reason, the season zones. A 3-way split season may be 10. A 3-way split season may be must immediately close. In the selected in Oregon’s South Coast Zone. selected. The daily dark goose bag limit designated areas of the Washington Arizona, Colorado, Idaho, Montana, is 4 dark geese and 4 white geese except Southwest Quota Zone, a special late Nevada, New Mexico, Utah, and for hunting days that occur after the last dark goose season may be held between Wyoming: Except as subsequently Sunday in January when only white- the Saturday following the close of the noted, 107-day seasons may be selected, fronted geese may be taken with a daily general goose season and March 10. with outside dates between the Saturday bag limit of 2. In the Northwest Special Permit Zone nearest September 24 (September 22), Northwest Special Permit Zone: of Oregon, the framework closing date is and the last Sunday in January (January Except for designated areas outside of extended to the Sunday closest to March 27). Basic daily bag limits are 4 light Tillamook County, the daily bag limit of 1 (March 2). Regular dark goose seasons geese and 4 dark geese. dark geese is 4 including not more than may be split into 3 segments within the Split Seasons: Unless otherwise 2 cackling or Aleutian geese. In those Oregon and Washington quota zones. specified, seasons for geese may be split designated areas of Tillamook County Swans into up to 3 segments. Three-way split open to hunting, the daily bag limit of seasons for Canada geese and white- dark geese is 2. In portions of the Pacific Flyway (Montana, Nevada, and Utah), an open fronted geese require Pacific Flyway South Coast Zone: The daily dark Council and U.S. Fish and Wildlife season for taking a limited number of goose bag limit is 4 including cackling swans may be selected. Permits will be Service approval and a 3-year and Aleutian geese. evaluation by each participating State. issued by the State and will authorize Southwest Zone: The daily dark goose each permittee to take no more than 1 Brant Season bag limit is 4 including cackling and swan per season with each permit. Aleutian geese. Oregon may select a 16-day season, Nevada may issue up to 2 permits per Washington a 16-day season, and Washington: The daily bag limit is 4 hunter. Montana and Utah may only California a 30-day season. Days must geese. A 107-day season may be selected issue 1 permit per hunter. Each State’s be consecutive. Washington and in Areas 4 and 5 (eastern Washington). season may open no earlier than the California may select hunting seasons Southwest Quota Zone: In the Saturday nearest October 1 (September by up to two zones. The daily bag limit Southwest Quota Zone, except for 29). These seasons are also subject to the is 2 brant and is in addition to dark designated areas, there will be no open following conditions: goose limits. In Oregon and California, season on Canada geese. In the Montana: No more than 500 permits the brant season must end no later than designated areas, individual quotas will may be issued. The season must end no December 15. be established that collectively will not later than December 1. The State must Arizona: The daily bag limit for dark exceed 85 dusky geese. See section on implement a harvest-monitoring geese is 3. quota zones. In this area, the daily bag program to measure the species limit may include 2 cackling geese. In composition of the swan harvest and California Southwest Quota Zone Area 2B (Pacific should use appropriate measures to Northeastern Zone: The daily bag County), the daily bag limit may include maximize hunter compliance in limit is 6 dark geese and may include no 1 Aleutian goose. reporting bill measurement and color more than 1 cackling Canada goose or 1 Colorado: The daily bag limit for dark information. Aleutian Canada goose. geese is 3 geese. Utah: No more than 2,000 permits may be issued. During the swan season, Southern Zone: In the Imperial Idaho: The daily bag limit is 4 geese. County Special Management Area, light no more than 10 trumpeter swans may geese only may be taken from the end Nevada: The daily bag limit for dark be taken. The season must end no later of the general goose hunting season geese is 3. than the second Sunday in December through the first Sunday in February New Mexico: The daily bag limit for (December 9) or upon attainment of 10 (February 3). dark geese is 3. trumpeter swans in the harvest, Balance-of-the-State Zone: Limits may Utah: The daily bag limit for dark whichever occurs earliest. The Utah not include more than 6 dark geese per geese is 3. season remains subject to the terms of

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the Memorandum of Agreement entered In the Central Flyway: the Maine State line in Rollinsford on into with the Service in August 2001, —The season may be 107 days, from the NH 4 to the city of Dover, south to NH regarding harvest monitoring, season Saturday nearest October 1 108, south along NH 108 through closure procedures, and education (September 29) to January 31. Madbury, Durham, and Newmarket to requirements to minimize the take of —In the Central Flyway portion of NH 85 in Newfields, south to NH 101 trumpeter swans during the swan Montana, no more than 500 permits in Exeter, east to NH 51 (Exeter- season. may be issued. Hampton Expressway), east to I–95 Nevada: No more than 650 permits —In North Dakota, no more than 2,200 (New Hampshire Turnpike) in Hampton, and south along I–95 to the may be issued. During the swan season, permits may be issued. —In South Dakota, no more than 1,300 Massachusetts State line. no more than 5 trumpeter swans may be permits may be issued. Inland Zone: That portion of the State taken. The season must end no later north and west of the above boundary than the Sunday following January 1 Area, Unit, and Zone Descriptions and along the Massachusetts State line (January 6) or upon attainment of 5 Ducks (Including Mergansers) and crossing the Connecticut River to trumpeter swans in the harvest, Coots Interstate 91 and northward in Vermont whichever occurs earliest. Atlantic Flyway to Route 2, east to 102, northward to the In addition, the States of Utah and Canadian border. Nevada must implement a harvest- Connecticut New Jersey monitoring program to measure the North Zone: That portion of the State species composition of the swan north of I–95. Coastal Zone: That portion of the harvest. The harvest-monitoring South Zone: Remainder of the State. State seaward of a line beginning at the program must require that all harvested New York State line in Raritan Bay and Maine swans or their species-determinant parts extending west along the New York be examined by either State or Federal North Zone: That portion north of the State line to NJ 440 at Perth Amboy; biologists for the purpose of species line extending east along Maine State west on NJ 440 to the Garden State classification. The States should use Highway 110 from the New Hampshire Parkway; south on the Garden State appropriate measures to maximize and Maine State line to the intersection Parkway to the shoreline at Cape May hunter compliance in providing bagged of Maine State Highway 11 in Newfield; and continuing to the Delaware State swans for examination. Further, the then north and east along Route 11 to line in Delaware Bay. North Zone: That portion of the State States of Montana, Nevada, and Utah the intersection of U.S. Route 202 in west of the Coastal Zone and north of must achieve at least an 80-percent Auburn; then north and east on Route a line extending west from the Garden compliance rate, or subsequent permits 202 to the intersection of Interstate Highway 95 in Augusta; then north and State Parkway on NJ 70 to the New will be reduced by 10 percent. All three Jersey Turnpike, north on the turnpike States must provide to the Service by east along I–95 to Route 15 in Bangor; then east along Route 15 to Route 9; to U.S. 206, north on U.S. 206 to U.S. June 30, 2008, a report detailing harvest, 1 at Trenton, west on U.S. 1 to the hunter participation, reporting then east along Route 9 to Stony Brook in Baileyville; then east along Stony Pennsylvania State line in the Delaware compliance, and monitoring of swan Brook to the United States border. River. populations in the designated hunt South Zone: Remainder of the State. South Zone: That portion of the State areas. not within the North Zone or the Coastal Massachusetts Tundra Swans Zone. Western Zone: That portion of the New York In portions of the Atlantic Flyway State west of a line extending south (North Carolina and Virginia) and the from the Vermont State line on I–91 to Lake Champlain Zone: The U.S. Central Flyway (North Dakota, South MA 9, west on MA 9 to MA 10, south portion of Lake Champlain and that area Dakota [east of the Missouri River], and on MA 10 to U.S. 202, south on U.S. 202 east and north of a line extending along that portion of Montana in the Central to the Connecticut State line. NY 9B from the Canadian border to U.S. Flyway), an open season for taking a Central Zone: That portion of the 9, south along U.S. 9 to NY 22 south of limited number of tundra swans may be State east of the Berkshire Zone and Keesville; south along NY 22 to the west selected. Permits will be issued by the west of a line extending south from the shore of South Bay, along and around States that authorize the take of no more New Hampshire State line on I–95 to the shoreline of South Bay to NY 22 on than 1 tundra swan per permit. A U.S. 1, south on U.S. 1 to I–93, south on the east shore of South Bay; southeast second permit may be issued to hunters I–93 to MA 3, south on MA 3 to U.S. along NY 22 to U.S. 4, northeast along U.S. 4 to the Vermont State line. from unused permits remaining after the 6, west on U.S. 6 to MA 28, west on MA Long Island Zone: That area first drawing. The States must obtain 28 to I–195, west to the Rhode Island consisting of Nassau County, Suffolk harvest and hunter participation data. State line; except the waters, and the lands 150 yards inland from the high- County, that area of Westchester County These seasons are also subject to the southeast of I–95, and their tidal waters. following conditions: water mark, of the Assonet River upstream to the MA 24 bridge, and the Western Zone: That area west of a line In the Atlantic Flyway Taunton River upstream to the Center extending from Lake Ontario east along St.-Elm St. bridge shall be in the Coastal the north shore of the Salmon River to —The season is experimental. Zone. I–81, and south along I–81 to the —The season may be 90 days, from Coastal Zone: That portion of Pennsylvania State line. October 1 to January 31. Massachusetts east and south of the Northeastern Zone: That area north of Central Zone. a line extending from Lake Ontario east —In North Carolina, no more than 5,000 along the north shore of the Salmon permits may be issued. New Hampshire River to I–81 to NY 31, east along NY —In Virginia, no more than 600 permits Coastal Zone: That portion of the 31 to NY 13, north along NY 13 to NY may be issued. State east of a line extending west from 49, east along NY 49 to NY 365, east

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along NY 365 to NY 28, east along NY Mississippi Flyway South Zone: That portion of the State 28 to NY 29, east along NY 29 to I–87, between the North and Ohio River Zone Alabama north along I–87 to U.S. 9 (at Exit 20), boundaries. north along U.S. 9 to NY 149, east along South Zone: Mobile and Baldwin Iowa NY 149 to U.S. 4, north along U.S. 4 to Counties. the Vermont State line, exclusive of the North Zone: The remainder of North Zone: That portion of the State Lake Champlain Zone. Alabama. north of a line extending east from the Nebraska border along State Highway Southeastern Zone: The remaining Illinois portion of New York. 175 to State Highway 37, southeast North Zone: That portion of the State along State Highway 37 to State Pennsylvania north of a line extending west from the Highway 183, northeast along State Indiana border along Peotone-Beecher Highway 183 to State Highway 141, east Lake Erie Zone: The Lake Erie waters Road to Illinois Route 50, south along along State Highway 141 to U.S. of Pennsylvania and a shoreline margin Illinois Route 50 to Wilmington-Peotone Highway 30, then east along U.S. along Lake Erie from New York on the Road, west along Wilmington-Peotone Highway 30 to the Illinois border. east to Ohio on the west extending 150 Road to Illinois Route 53, north along South Zone: The remainder of Iowa. yards inland, but including all of Illinois Route 53 to New River Road, Presque Isle Peninsula. northwest along New River Road to Kentucky Northwest Zone: The area bounded on Interstate Highway 55, south along I–55 West Zone: All counties west of and the north by the Lake Erie Zone and to Pine Bluff-Lorenzo Road, west along including Butler, Daviess, Ohio, including all of Erie and Crawford Pine Bluff-Lorenzo Road to Illinois Simpson, and Warren Counties. Counties and those portions of Mercer Route 47, north along Illinois Route 47 East Zone: The remainder of and Venango Counties north of I–80. to I–80, west along I–80 to I–39, south Kentucky. North Zone: That portion of the State along I–39 to Illinois Route 18, west east of the Northwest Zone and north of along Illinois Route 18 to Illinois Route Louisiana a line extending east on I–80 to U.S. 29, south along Illinois Route 29 to Illinois Route 17, west along Illinois West Zone: That portion of the State 220, Route 220 to I–180, I–180 to I–80, west and south of a line extending south and I–80 to the Delaware River. Route 17 to the Mississippi River, and due south across the Mississippi River from the Arkansas State line along South Zone: The remaining portion of to the Iowa border. Louisiana Highway 3 to Bossier City, east along Interstate Highway 20 to Pennsylvania. Central Zone: That portion of the Minden, south along Louisiana 7 to State south of the North Zone to a line Vermont Ringgold, east along Louisiana 4 to extending west from the Indiana border Jonesboro, south along U.S. Highway Lake Champlain Zone: The U.S. along Interstate Highway 70 to Illinois 167 to Lafayette, southeast along U.S. 90 portion of Lake Champlain and that area Route 4, south along Illinois Route 4 to to the Mississippi State line. north and west of the line extending Illinois Route 161, west along Illinois from the New York State line along U.S. Route 161 to Illinois Route 158, south East Zone: The remainder of 4 to VT 22A at Fair Haven; VT 22A to and west along Illinois Route 158 to Louisiana. U.S. 7 at Vergennes; U.S. 7 to the Illinois Route 159, south along Illinois Michigan Canadian border. Route 159 to Illinois Route 156, west Interior Zone: That portion of along Illinois Route 156 to A Road, North Zone: The Upper Peninsula. Vermont west of the Lake Champlain north and west on A Road to Levee Middle Zone: That portion of the Zone and eastward of a line extending Road, north on Levee Road to the south Lower Peninsula north of a line from the Massachusetts State line at shore of New Fountain Creek, west beginning at the Wisconsin State line in Interstate 91; north along Interstate 91 to along the south shore of New Fountain Lake Michigan due west of the mouth of U.S. 2; east along U.S. 2 to VT 102; Creek to the Mississippi River, and due Stony Creek in Oceana County; then due north along VT 102 to VT 253; north west across the Mississippi River to the east to, and easterly and southerly along along VT 253 to the Canadian border. Missouri border. the south shore of Stony Creek to Scenic South Zone: The remainder of Illinois. Drive, easterly and southerly along Connecticut River Zone: The Scenic Drive to Stony Lake Road, remaining portion of Vermont east of Indiana easterly along Stony Lake and Garfield the Interior Zone. North Zone: That portion of the State Roads to Michigan Highway 20, east West Virginia north of a line extending east from the along Michigan 20 to U.S. Highway 10 Illinois State line along State Road 18 to Business Route (BR) in the city of Zone 1: That portion outside the U.S. Highway 31, north along U.S. 31 to Midland, easterly along U.S. 10 BR to boundaries in Zone 2. U.S. 24, east along U.S. 24 to U.S. 10, easterly along U.S. 10 to Zone 2 (Allegheny Mountain Upland): Huntington, then southeast along U.S. Interstate Highway 75/U.S. Highway 23, That area bounded by a line extending 224 to the Ohio State line. northerly along I–75/U.S. 23 to the U.S. south along U.S. 220 through Keyser to Ohio River Zone: That portion of the 23 exit at Standish, easterly along U.S. U.S. 50; U.S. 50 to WV 93; WV 93 south State south of a line extending east from 23 to the centerline of the Au Gres to WV 42; WV 42 south to Petersburg; the Illinois State line along Interstate River, then southerly along the WV 28 south to Minnehaha Springs; WV Highway 64 to New Albany, east along centerline of the Au Gres River to 39 west to U.S. 219; U.S. 219 south to State Road 62 to State Road 56, east Saginaw Bay, then on a line directly east I–64; I–64 west to U.S. 60; U.S. 60 west along State Road 56 to Vevay, east and 10 miles into Saginaw Bay, and from to U.S. 19; U.S. 19 north to I–79, I–79 north on State 156 along the Ohio River that point on a line directly northeast to north to I–68; I–68 east to the Maryland to North Landing, north along State 56 the Canadian border. State line; and along the State line to the to U.S. Highway 50, then northeast South Zone: The remainder of point of beginning. along U.S. 50 to the Ohio State line. Michigan.

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Minnesota South Zone: The remainder of Ohio. Roosevelt, Sheridan, Stillwater, Sweet Grass, Valley, Wheatland, Wibaux, and North Duck Zone: That portion of the Tennessee State north of a line extending east from Yellowstone. Reelfoot Zone: All or portions of Lake Zone 2: The remainder of Montana. the North Dakota State line along State and Obion Counties. Highway 210 to State Highway 23, east State Zone: The remainder of Nebraska along State Highway 23 to State Tennessee. High Plains Zone: That portion of Highway 39, then east along State Nebraska lying west of a line beginning Highway 39 to the Wisconsin State line Wisconsin at the South Dakota-Nebraska border on at the Oliver Bridge. North Zone: That portion of the State U.S. 183, south on U.S. 183 to U.S. 20, South Duck Zone: The remainder of north of a line extending east from the west on U.S. 20 to NE 7, south on NE Minnesota. Minnesota State line along U.S. 7 to NE 91, southwest on NE 91 to NE Missouri Highway 10 to U.S. Highway 41, then 2, southeast on NE 2 to NE 92, west on north on U.S. Highway 41 to the NE 92 to NE 40, south on NE 40 to NE North Zone: That portion of Missouri Michigan State line. 47, south on NE 47 to NE 23, east on NE north of a line running west from the South Zone: The remainder of 23 to U.S. 283 and south on U.S. 283 to Illinois State line (Lock and Dam 25) on Wisconsin. the Kansas-Nebraska border. Lincoln County Highway N to Missouri Low Plains Zone 1: That portion of Central Flyway Highway 79; south on Missouri Dixon County west of NE 26E Spur and Highway 79 to Missouri Highway 47; Colorado (Central Flyway Portion) north of NE 12; those portions of Cedar west on Missouri Highway 47 to Eastern Plains Zone: That portion of County north of NE 12; those portions Interstate 70; west on Interstate 70 to the the State east of Interstate 25, and all of of Knox counties north of NE 12 to Kansas State line. El Paso, Pueblo, Heurfano, and Las intersection of Niobrara River; all of South Zone: That portion of Missouri Animas Counties. Boyd County; Keya Paha County east of south of a line running west from the Mountain/Foothills Zone: That U.S. 183. Both banks of the Niobrara Illinois State line on Missouri Highway portion of the State west of Interstate 25 River in Keya Paha, Boyd, and Knox 34 to Interstate 55; south on Interstate and east of the Continental Divide, counties east of U.S. 183 shall be 55 to U.S. Highway 62; west on U.S. except El Paso, Pueblo, Heurfano, and included in Zone 1. Highway 62 to Missouri Highway 53; Las Animas Counties. Low Plains Zone 2: Area bounded by north on Missouri Highway 53 to designated Federal and State highways Missouri Highway 51; north on Missouri Kansas and political boundaries beginning at Highway 51 to U.S. Highway 60; west High Plains Zone: That portion of the the Kansas-Nebraska border on U.S. 75 on U.S. Highway 60 to Missouri State west of U.S. 283. to U.S. 136; east to the intersection of Highway 21; north on Missouri Low Plains Early Zone: That area of U.S. 136 and the Steamboat Trace Highway 21 to Missouri Highway 72; Kansas east of U.S. 283, and generally (Trace); north along the Trace to the west on Missouri Highway 72 to west of a line beginning at the Junction intersection with Federal Levee R–562; Missouri Highway 32; west on Missouri of the Nebraska border and KS 28; south north along Federal Levee R–562 to the Highway 32 to U.S. Highway 65; north on KS 28 to U.S. 36; east on U.S. 36 to intersection with the Trace; north along on U.S. Highway 65 to U.S. Highway 54; KS 199; south on KS 199 to Republic the Trace/Burlington Northern Railroad west on U.S. Highway 54 to the Kansas Co. Road 563; south on Republic Co. right-of-way to NE 2; west to U.S. 75; State line. Road 563 to KS 148; east on KS 148 to north to NE 2; west to NE 43; north to Middle Zone: The remainder of Republic Co. Road 138; south on U.S. 34; east to NE 63; north and west Missouri. Republic Co. Road 138 to Cloud Co. to U.S. 77; north to NE 92; west to U.S. 81; south to NE 66; west to NE 14; south Ohio Road 765; south on Cloud Co. Road 765 to KS 9; west on KS 9 to U.S. 24; west to County Road 22 (Hamilton County); North Zone: That portion of the State on U.S. 24 to U.S. 281; north on U.S. west to County Road M; south to County north of a line extending east from the 281 to U.S. 36; west on U.S. 36 to U.S. Road 21; west to County Road K; south Indiana State line along U.S. Highway 183; south on U.S. 183 to U.S. 24; west U.S. 34; west to NE 2; south to U.S. I– 33 to State Route 127, south along SR on U.S. 24 to KS 18; southeast on KS 18 80; west to Gunbarrel Road. (Hall/ 127 to SR 703, south along SR 703 to SR to U.S. 183; south on U.S. 183 to KS 4; Hamilton county line); south to Giltner 219, east along SR 219 to SR 364, north east on KS 4 to I–135; south on I–135 Road; west to U.S. 281; south to U.S. 34; along SR 364 to SR 703, east along SR to KS 61; southwest on KS 61 to KS 96; west to NE 10; north to County Road 703 to SR 66, north along SR 66 to U.S. northwest on KS 96 to U.S. 56; ‘‘R’’ (Kearney County) and County Road 33, east along U.S. 33 to SR 385, east southwest on U.S. 56 to KS 19; east on #742 (Phelps County); west to County along SR 385 to SR 117, south along SR KS 19 to U.S. 281; south on U.S. 281 to Road #438 (Gosper County line); south 117 to SR 273, east along SR 273 to SR U.S. 54; west on U.S. 54 to U.S. 183; along County Road #438 (Gosper County 31, south along SR 31 to SR 739, east north on U.S. 183 to U.S. 56; southwest line) to County Road #726 (Furnas along SR 739 to SR 4, north along SR on U.S. 56 to Ford Co. Road 126; south County line); east to County Road #438 4 to SR 95, east along SR 95 to SR 13, on Ford Co. Road 126 to U.S. 400; (Harlan County line); south to U.S. 34; southeast along SR 13 to SR 3, northeast northwest on U.S. 400 to U.S. 283. south and west to U.S. 136; east to NE along SR 3 to SR 60, north along SR 60 Low Plains Late Zone: The remainder 14; south to the Kansas-Nebraska to U.S. 30, east along U.S. 30 to SR 3, of Kansas. border; west to U.S. 283; north to NE 23; south along SR 3 to SR 226, south along west to NE 47; north to U.S. 30; east to SR 226 to SR 514, southwest along SR Montana (Central Flyway Portion) NE 14; north to NE 52; west and north 514 to SR 754, south along SR 754 to SR Zone 1: The Counties of Blaine, to NE 91 to U.S. 281; south to NE 22; 39/60, east along SR 39/60 to SR 241, Carbon, Carter, Daniels, Dawson, Fallon, west to NE 11; northwest to NE 91; west north along SR 241 to U.S. 30, east along Fergus, Garfield, Golden Valley, Judith to Loup County Line; north to Loup- U.S. 30 to SR 39, east along SR 39 to the Basin, McCone, Musselshell, Petroleum, Brown county line; east along northern Pennsylvania State line. Phillips, Powder River, Richland, boundaries of Loup, Garfield and

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Wheeler counties; south on the High Plains Unit and north of a line California Wheeler-Antelope county line to NE 70; extending east along U.S. 212 to the Northeastern Zone: In that portion of east to NE 14; south to NE 39; southeast Minnesota State line. California lying east and north of a line to NE 22; east to U.S. 81; southeast to South Zone: That portion of Gregory beginning at the intersection of U.S. 30; east to U.S. 75; north to the County east of SD 47 and south of SD Interstate 5 with the California-Oregon Washington County line; east to the 44; Charles Mix County south of SD 44 line; south along Interstate 5 to its to the Douglas County line; south on SD Iowa-Nebraska border; south along the junction with Walters Lane south of the 50 to Geddes; east on the Geddes Iowa-Nebraska border; to the beginning town or Yreka; west along Walters Lane Highway to U.S. 281; south on U.S. 281 at U.S. 75 and the Kansas-Nebraska to its junction with Easy Street; south and U.S. 18 to SD 50; south and east on border. along Easy Street to the junction with Low Plains Zone 3: The area east of SD 50 to the Bon Homme County line; Old Highway 99: south along Old the High Plains Zone, excluding Low the Counties of Bon Homme, Yankton, Highway 99 to the point of intersection Plains Zone 1, north of Low Plains Zone and Clay south of SD 50; and Union with Interstate 5 north of the town of 2. County south and west of SD 50 and I– Weed; south along Interstate 5 to its Low Plains Zone 4: The area east of 29. the High Plains Zone and south of Zone Middle Zone: The remainder of South junction with Highway 89; east and 2. Dakota. south along Highway 89 to Main Street Greenville; north and east to its junction New Mexico (Central Flyway Portion) Texas with North Valley Road; south to its North Zone: That portion of the State High Plains Zone: That portion of the junction of Diamond Mountain Road; north of I–40 and U.S. 54. State west of a line extending south north and east to its junction with North South Zone: The remainder of New from the Oklahoma State line along U.S. Arm Road; south and west to the Mexico. 183 to Vernon, south along U.S. 283 to junction of North Valley Road; south to the junction with Arlington Road (A22); North Dakota Albany, south along TX 6 to TX 351 to Abilene, south along U.S. 277 to Del west to the junction of Highway 89; High Plains Unit: That portion of the Rio, then south along the Del Rio south and west to the junction of State south and west of a line from the International Toll Bridge access road to Highway 70; east on Highway 70 to South Dakota State line along U.S. 83 the Mexico border. Highway 395; south and east on and I–94 to ND 41, north to U.S. 2, west Low Plains North Zone: That portion Highway 395 to the point of intersection to the Williams/Divide County line, of northeastern Texas east of the High with the California-Nevada State line; then north along the County line to the Plains Zone and north of a line north along the California-Nevada State Canadian border. beginning at the International Toll line to the junction of the California- Low Plains Unit: The remainder of Bridge south of Del Rio, then extending Nevada-Oregon State lines; west along North Dakota. east on U.S. 90 to San Antonio, then the California-Oregon State line to the Oklahoma continuing east on I–10 to the Louisiana point of origin. Colorado River Zone: Those portions High Plains Zone: The Counties of State line at Orange, Texas. Low Plains South Zone: The of San Bernardino, Riverside, and Beaver, Cimarron, and Texas. Imperial Counties east of a line Low Plains Zone 1: That portion of remainder of Texas. extending from the Nevada State line the State east of the High Plains Zone Wyoming (Central Flyway portion) south along U.S. 95 to Vidal Junction; and north of a line extending east from Zone 1: The Counties of Converse, south on a road known as ‘‘Aqueduct the Texas State line along OK 33 to OK Goshen, Hot Springs, Natrona, Platte, Road’’ in San Bernardino County 47, east along OK 47 to U.S. 183, south and Washakie; and the portion of Park through the town of Rice to the San along U.S. 183 to I–40, east along I–40 County east of the Shoshone National to U.S. 177, north along U.S. 177 to OK Bernardino-Riverside County line; south Forest boundary and south of a line 33, east along OK 33 to OK 18, north on a road known in Riverside County as beginning where the Shoshone National along OK 18 to OK 51, west along OK the ‘‘Desert Center to Rice Road’’ to the Forest boundary meets Park County 51 to I–35, north along I–35 to U.S. 412, town of Desert Center; east 31 miles on Road 8VC, east along Park County Road west along U.S. 412 to OK 132, then I–10 to the Wiley Well Road; south on 8VC to Park County Road 1AB, north along OK 132 to the Kansas State this road to Wiley Well; southeast along continuing east along Park County Road line. the Army-Milpitas Road to the Blythe, Low Plains Zone 2: The remainder of 1AB to Wyoming Highway 120, north Brawley, Davis Lake intersections; south Oklahoma. along WY Highway 120 to WY Highway on the Blythe-Brawley paved road to the 294, south along WY Highway 294 to Ogilby and Tumco Mine Road; south on South Dakota Lane 9, east along Lane 9 to Powel and this road to U.S. 80; east seven miles on High Plains Zone: That portion of the WY Highway 14A, and finally east along U.S. 80 to the Andrade-Algodones Road; State west of a line beginning at the WY Highway 14A to the Park County south on this paved road to the Mexican North Dakota State line and extending and Big Horn County line. border at Algodones, Mexico. south along U.S. 83 to U.S. 14, east on Zone 2: The remainder of Wyoming. Southern Zone: That portion of U.S. 14 to Blunt, south on the Blunt- Pacific Flyway southern California (but excluding the Canning road to SD 34, east and south Colorado River Zone) south and east of on SD 34 to SD 50 at Lee’s Corner, south Arizona a line extending from the Pacific Ocean on SD 50 to I–90, east on I–90 to SD 50, Game Management Units (GMU) as east along the Santa Maria River to CA south on SD 50 to SD 44, west on SD follows: 166 near the City of Santa Maria; east on 44 across the Platte-Winner bridge to SD South Zone: Those portions of GMUs CA 166 to CA 99; south on CA 99 to the 47, south on SD 47 to U.S. 18, east on 6 and 8 in Yavapai County, and GMUs crest of the Tehachapi Mountains at U.S. 18 to SD 47, south on SD 47 to the 10 and 12B–45. Tejon Pass; east and north along the Nebraska State line. North Zone: GMUs 1–5, those crest of the Tehachapi Mountains to CA North Zone: That portion of portions of GMUs 6 and 8 within 178 at Walker Pass; east on CA 178 to northeastern South Dakota east of the Coconino County, and GMUs 7, 9, 12A. U.S. 395 at the town of Inyokern; south

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on U.S. 395 to CA 58; east on CA 58 to Utah Maryland I–15; east on I–15 to CA 127; north on Zone 1: All of Box Elder, Cache, Resident Population (RP) Zone: CA 127 to the Nevada State line. Daggett, Davis, Duchesne, Morgan, Rich, Garrett, Allegany, Washington, Southern San Joaquin Valley Salt Lake, Summit, Unitah, Utah, Frederick, Howard, and Montgomery Temporary Zone: All of Kings and Wasatch, and Weber Counties, and that Counties; that portion of Baltimore Tulare Counties and that portion of part of Toole County north of I–80. County south of Route 138, Route 137, Kern County north of the Southern Zone 2: The remainder of Utah. and Mount Carmel Road; that portion of Zone. Anne Arundel County west of Interstate Washington Balance-of-the-State Zone: The 895, Interstate 97 and Route 3; that remainder of California not included in East Zone: All areas east of the Pacific portion of Prince George’s County west the Northeastern, Southern, and Crest Trail and east of the Big White of Route 3 and Route 301, that portion Colorado River Zones, and the Southern Salmon River in Klickitat County. of Charles County west of Route 301 to San Joaquin Valley Temporary Zone. Columbia Basin Mallard Management the Virginia State line; and that portion Unit: Same as East Zone. of Carroll County south of Route 88, Idaho West Zone: All areas to the west of the west of Route 30 from the intersection East Zone. Zone 1: Includes all lands and waters of Route 30 and Route 88 to the within the Fort Hall Indian Reservation, Wyoming intersection of Route 30 and Route 482, south of Route 482, south of Route 27 including private inholdings; Bannock Snake River Zone: Beginning at the County; Bingham County, except that from the intersection of Route 27 and south boundary of Yellowstone National Route 482 to the intersection of Route portion within the Blackfoot Reservoir Park and the Continental Divide; south drainage; and Power County east of ID 27 and Route 97, and west of Route 97 along the Continental Divide to Union from the Intersection of Route 27 and 37 and ID 39. Pass and the Union Pass Road (U.S.F.S. Zone 2: Includes the following Route 97 to the Pennsylvania line. Road 600); west and south along the AP Zone: Remainder of the State. Counties or portions of Counties: Union Pass Road to U.S. F.S. Road 605; Adams; Bear Lake; Benewah; Bingham south along U.S.F.S. Road 605 to the Massachusetts within the Blackfoot Reservoir drainage; Bridger-Teton National Forest boundary; NAP Zone: Central Zone (same as for Blaine; Bonner; Bonneville; Boundary; along the national forest boundary to the ducks) and that portion of the Coastal Butte; Camas; Caribou except the Fort Idaho State line; north along the Idaho Zone that lies north of route 139 from Hall Indian Reservation; Cassia within State line to the south boundary of Green Harbor. the Minidoka National Wildlife Refuge; Yellowstone National Park; east along AP Zone: Remainder of the State. Clark; Clearwater; Custer; Elmore within the Yellowstone National Park boundary Special Late Season Area: That the Camas Creek drainage; Franklin; to the Continental Divide. portion of the Coastal Zone (see duck Fremont; Idaho; Jefferson; Kootenai; Balance of Flyway Zone: Balance of zones) that lies north of the Cape Cod Latah; Lemhi; Lewis; Madison; Nez the Pacific Flyway in Wyoming outside Canal and east of Route 3, north to the Perce; Oneida; Power within the the Snake River Zone. New Hampshire line. Minidoka National Wildlife Refuge; Shoshone; Teton; and Valley Counties. Geese New Hampshire Zone 3: Includes the following Atlantic Flyway Same zones as for ducks. Counties or portions of Counties: Ada; Connecticut New Jersey Boise; Canyon; Cassia except within the Minidoka National Wildlife Refuge; NAP L-Unit: That portion of Fairfield North: That portion of the State Elmore except the Camas Creek County north of Interstate 95 and that within a continuous line that runs east drainage; Gem; Gooding; Jerome; portion of New Haven County; starting along the New York State boundary line Lincoln; Minidoka; Owyhee; Payette; at I–95 bridge on Housatonic River; to the Hudson River; then south along Power west of ID 37 and ID 39 except north of Interstate 95; west of Route 10 the New York State boundary to its that portion within the Minidoka to the intersection of Interstate 691; west intersection with Route 440 at Perth National Wildlife Refuge; Twin Falls; along Interstate 691 to Interstate 84; Amboy; then west on Route 440 to its and Washington Counties. west and south on Interstate 84 to the intersection with Route 287; then west Naugatuck River; north on the along Route 287 to its intersection with Nevada Naugatuck River to the Litchfield Route 206 in Bedminster (Exit 18); then Lincoln and Clark County Zone: All of County line, then extending west along north along Route 206 to its intersection Clark and Lincoln Counties. the Litchfield County line to the with Route 94: then west along Route 94 intersection of the Litchfield and to the tollbridge in Columbia; then north Remainder-of-the-State Zone: The along the Pennsylvania State boundary remainder of Nevada. Fairfield County lines. NAP H-Unit: All of the rest of the in the Delaware River to the beginning Oregon State not included in the AP or NAP– point. L descriptions. South: That portion of the State Zone 1: Clatsop, Tillamook, Lincoln, AP Unit: Litchfield County and the within a continuous line that runs west Lane, Douglas, Coos, Curry, Josephine, portion of Hartford County, west of a from the Atlantic Ocean at Ship Bottom Jackson, Linn, Benton, Polk, Marion, line beginning at the Massachusetts along Route 72 to Route 70; then west Yamhill, Washington, Columbia, State line in Suffield and extending along Route 70 to Route 206; then south Multnomah, Clackamas, Hood River, south along Route 159 to its intersection along Route 206 to Route 536; then west Wasco, Sherman, Gilliam, Morrow and with Route 91 in Hartford, and then along Route 536 to Route 322; then west Umatilla Counties. extending south along Route 91 to its along Route 322 to Route 55; then south Columbia Basin Mallard Management intersection with the Hartford/ along Route 55 to Route 553 (Buck Unit: Gilliam, Morrow, and Umatilla Middlesex County line. Road); then south along Route 553 to Counties. South Zone: Same as for ducks. Route 40; then east along Route 40 to Zone 2: The remainder of the State. North Zone: Same as for ducks. route 55; then south along Route 55 to

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Route 552 (Sherman Avenue); then west Route 5S, southeast along Route 5S to 87 to Steuben County Route 96, east along Route 552 to Carmel Road; then Schenectady County Route 58, along Route 96 to Steuben County Route south along Carmel Road to Route 49; southwest along Route 58 to the NYS 114, east along Route 114 to Schuyler then east along Route 49 to Route 555; Thruway, south along the Thruway to County Route 23, east and southeast then south along Route 555 to Route Route 7, southwest along Route 7 to along Route 23 to Schuyler County 553; then east along Route 553 to Route Schenectady County Route 103, south Route 28, southeast along Route 28 to 649; then north along Route 649 to along Route 103 to Route 406, east along Route 409 at Watkins Glen, south along Route 670; then east along Route 670 to Route 406 to Schenectady County Route Route 409 to Route 14, south along Route 47; then north along Route 47 to 99 (Windy Hill Road), south along Route Route 14 to Route 224 at Montour Falls, Route 548; then east along Route 548 to 99 to Dunnsville Road, south along east along Route 224 to Route 228 in Route 49; then east along Route 49 to Dunnsville Road to Route 397, Odessa, north along Route 228 to Route Route 50; then south along Route 50 to southwest along Route 397 to Route 146 79 in Mecklenburg, east along Route 79 Route 9; then south along Route 9 to at Altamont, west along Route 146 to to Route 366 in Ithaca, northeast along Route 625 (Sea Isle City Boulevard); Albany County Route 252, northwest Route 366 to Route 13, northeast along then east along Route 625 to the Atlantic along Route 252 to Schenectady County Route 13 to Interstate Route 81 in Ocean; then north to the beginning Route 131, north along Route 131 to Cortland, north along Route 81 to the point. Route 7, west along Route 7 to Route 10 north shore of the Salmon River to shore New York at Richmondville, south on Route 10 to of Lake Ontario, extending generally Route 23 at Stamford, west along Route northwest in a straight line to the Lake Champlain Goose Area: That 23 to the south bank of the Susquehanna nearest point of the International area of New York State lying east and River, southwest along the south bank of boundary with Canada, south and west north of a continuous line extending the Susquehanna River to Interstate along the International boundary to the along Route 11 from the New York- Route 88 near Harpursville, west along point of beginning. Canada International boundary south to Route 88 to Route 79, northwest along Route 9B, south along Route 9B to Route Hudson Valley Goose Area: That area Route 79 to Route 26 in Whitney Point, of New York State lying within a 9, south along Route 9 to Route 22 south southwest along Route 26 to Interstate of Keeseville, south along Route 22 to continuous line extending from Route 4 Route 81, north along Route 81 to the at the New York-Vermont boundary, the west shore of South Bay along and point of beginning. around the shoreline of South Bay to west and south along Route 4 to Route Route 22 on the east shore of South Bay, West Central Goose Area: That area of 149 at Fort Ann, west on Route 149 to southeast along Route 22 to Route 4, New York State lying within a Route 9, south along Route 9 to northeast along Route 4 to the New continuous line beginning at the point Interstate Route 87 (at Exit 20 in Glens York-Vermont boundary. where the northerly extension of Route Falls), south along Route 87 to Route 29, Northeast Goose Area: The same as 269 (County Line Road on the Niagara- west along Route 29 to Route 147 at the Northeastern Waterfowl Hunting Orleans County boundary) meets the Kimball Corners, south along Route 147 Zone, which is that area of New York International boundary with Canada, to Schenectady County Route 40 (West State lying north of a continuous line south to the shore of Lake Ontario at the Glenville Road), west along Route 40 to extending from Lake Ontario east along eastern boundary of Golden Hill State Touareuna Road, south along Touareuna the north shore of the Salmon River to Park, south along the extension of Route Road to Schenectady County Route 59, Interstate 81, south along Interstate 269 and Route 269 to Route 104 at south along Route 59 to State Route 5, Route 81 to Route 31, east along Route Jeddo, west along Route 104 to Niagara east along Route 5 to the Lock 9 bridge, 31 to Route 13, north along Route 13 to County Route 271, south along Route southwest along the Lock 9 bridge to Route 49, east along Route 49 to Route 271 to Route 31E at Middleport, south Route 5S, southeast along Route 5S to 365, east along Route 365 to Route 28, along Route 31E to Route 31, west along Schenectady County Route 58, east along Route 28 to Route 29, east Route 31 to Griswold Street, south along southwest along Route 58 to the NYS along Route 29 to Interstate Route 87, Griswold Street to Ditch Road, south Thruway, south along the Thruway to north along Interstate Route 87 to Route along Ditch Road to Foot Road, south Route 7, southwest along Route 7 to 9 (at Exit 20), north along Route 9 to along Foot Road to the north bank of Schenectady County Route 103, south Route 149, east along Route 149 to Tonawanda Creek, west along the north along Route 103 to Route 406, east along Route 4, north along Route 4 to the New bank of Tonawanda Creek to Route 93, Route 406 to Schenectady County Route York-Vermont boundary, exclusive of south along Route 93 to the NYS 99 (Windy Hill Road), south along Route the Lake Champlain Zone. Thruway, east along the Thruway 90 to 99 to Dunnsville Road, south along East Central Goose Area: That area of Route 98 (at Thruway Exit 48) in Dunnsville Road to Route 397, New York State lying inside of a Batavia, south along Route 98 to Route southwest along Route 397 to Route 146 continuous line extending from 20, east along Route 20 to Route 19 in at Altamont, southeast along Route 146 Interstate Route 81 in Cicero, east along Pavilion Center, south along Route 19 to to Main Street in Altamont, west along Route 31 to Route 13, north along Route Route 63, southeast along Route 63 to Main Street to Route 156, southeast 13 to Route 49, east along Route 49 to Route 246, south along Route 246 to along Route 156 to Albany County Route 365, east along Route 365 to Route 39 in Perry, south along Route 39 Route 307, southeast along Route 307 to Route 28, east along Route 28 to Route to Route 19A (south of Castile), south Route 85A, southwest along Route 85A 29, east along Route 29 to Route 147 at and southeast along Route 19A to Route to Route 85, south along Route 85 to Kimball Corners, south along Route 147 436, east along Route 436 to Route 36 Route 443, southeast along Route 443 to to Schenectady County Route 40 (West in Dansville, south along Route 36 to Albany County Route 301 at Clarksville, Glenville Road), west along Route 40 to Route 17, east along Route 17 to Belfast southeast along Route 301 to Route 32, Touareuna Road, south along Touareuna Street at Bath, east along Belfast Street south along Route 32 to Route 23 at Road to Schenectady County Route 59, to Route 415 (West Washington Street), Cairo, west along Route 23 to Joseph south along Route 59 to State Route 5, southeast along Route 415 to Route 54, Chadderdon Road, southeast along east along Route 5 to the Lock 9 bridge, northeast along Route 54 to Steuben Joseph Chadderdon Road to Hearts southwest along the Lock 9 bridge to County Route 87, northeast along Route Content Road (Greene County Route 31),

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southeast along Route 31 to Route 32, lying north of State Route 25A and west south of U.S. Route 30 to SR 441, east south along Route 32 to Greene County of a continuous line extending of SR 441 to SR 743, east of SR 743 to Route 23A, east along Route 23A to northward from State Route 25A along intersection of I–81, east of I–81 to Interstate Route 87 (the NYS Thruway), Randall Road (near Shoreham) to North intersection of I–80, south of I–80 to south along Route 87 to Route 28 (Exit Country Road, then east to Sound Road New Jersey State line). 19) near Kingston, northwest on Route and then north to Long Island Sound SJBP Zone: Erie, Mercer, and 28 to Route 209, southwest on Route and then due north to the New York- Crawford Counties except for the 209 to the New York-Pennsylvania Connecticut boundary. Pymatuning Zone. boundary, southeast along the New North Carolina Pymatuning Zone: The area south of York-Pennsylvania boundary to the New SR 198 from the Ohio State line to York-New Jersey boundary, southeast SJBP Hunt Zone: Includes the intersection of SR 18, SR 18 south to SR along the New York-New Jersey following counties or portions of 618, SR 618 south to U.S. Route 6, U.S. boundary to Route 210 near Greenwood counties: Anson, Cabarrus, Chatham, Route 6 east to U.S. Route 322/SR 18, Davidson, Durham, Halifax (that portion Lake, northeast along Route 210 to U.S. Route 322/SR 18 west to east of NC 903), Montgomery (that Orange County Route 5, northeast along intersection of SR 3013, SR 3013 south portion west of NC 109), Northampton, Orange County Route 5 to Route 105 in to the Crawford/Mercer County line. the Village of Monroe, east and north Richmond (that portion south of NC 73 and west of U.S. 220 and north of U.S. AP Zone: The area east of route SR 97 along Route 105 to Route 32, northeast from Maryland State Line to the along Route 32 to Orange County Route 74), Rowan, Stanly, Union, and Wake. RP Hunt Zone: Includes the following intersection of SR 194, east of SR 194 to 107 (Quaker Avenue), east along Route intersection of U.S. Route 30, south of 107 to Route 9W, north along Route 9W counties or portions of counties: Alamance, Alleghany, Alexander, Ashe, U.S. Route 30 to SR 441, east of SR 441 to the south bank of Moodna Creek, to SR 743, east of SR 743 to intersection southeast along the south bank of Avery, Beaufort, Bertie (that portion of I–81, east of I–81 to intersection of I– Moodna Creek to the New Windsor- south and west of a line formed by NC 80, south of I–80 to New Jersey State Cornwall town boundary, northeast 45 at the Washington Co. line to U.S. 17 line. along the New Windsor-Cornwall town in Midway, U.S. 17 in Midway to U.S. boundary to the Orange-Dutchess 13 in Windsor, U.S. 13 in Windsor to Rhode Island County boundary (middle of the Hudson the Hertford Co. line), Bladen, Special Area for Canada Geese: Kent River), north along the county boundary Brunswick, Buncombe, Burke, Caldwell, and Providence Counties and portions to Interstate Route 84, east along Route Carteret, Caswell, Catawba, Cherokee, of the towns of Exeter and North 84 to the New York-Connecticut Clay, Cleveland, Columbus, Craven, Kingston within Washington County boundary, north along the New York- Cumberland, Davie, Duplin, Edgecombe, (see State regulations for detailed Connecticut boundary to the New York- Forsyth, Franklin, Gaston, Gates, descriptions). Massachusetts boundary, north along Graham, Granville, Greene, Guilford, the New York-Massachusetts boundary Halifax (that portion west of NC 903), South Carolina to the New York-Vermont boundary, Harnett, Haywood, Henderson, Hertford, Canada Goose Area: Statewide except north to the point of beginning. Hoke, Iredell, Jackson, Johnston, Jones, Eastern Long Island Goose Area (NAP Lee, Lenoir, Lincoln, McDowell, Macon, for Clarendon County, that portion of High Harvest Area): That area of Suffolk Madison, Martin, Mecklenburg, Orangeburg County north of SC County lying east of a line extending Mitchell, Montgomery (that portion that Highway 6, and that portion of Berkeley due south from the New York- is east of NC 109), Moore, Nash, New County north of SC Highway 45 from Connecticut boundary to the Hanover, Onslow, Orange, Pamlico, the Orangeburg County line to the northernmost end of Roanoke Avenue in Pender, Person, Pitt, Polk, Randolph, junction of SC Highway 45 and State the Town of Riverhead, south on Richmond (all of the county with Road S–8–31 and that portion west of Roanoke Avenue (which becomes exception of that portion that is south of the Santee Dam. County Route 73) to State Route 25, NC 73 and west of U.S. 220 and north Vermont west on Route 25 to Peconic Avenue, of U.S. 74), Robeson, Rockingham, south on Peconic Avenue to County Rutherford, Sampson, Scotland, Stokes, Same zones as for ducks. Route (CR) 104 (Riverleigh Avenue), Surry, Swain, Transylvania, Vance, Virginia south on CR 104 to CR 31 (Old Warren, Watauga, Wayne, Wilkes, Riverhead Road), south on CR 31 to Oak Wilson, Yadkin, and Yancey. AP Zone: The area east and south of Street, south on Oak Street to Potunk Northeast Hunt Unit: Includes the the following line—the Stafford County Lane, then west on Stevens Lane, then following counties or portions of line from the Potomac River west to south on Jessup Avenue (in counties: Bertie (that portion north and Interstate 95 at Fredericksburg, then Westhampton Beach) to Dune Road (CR east of a line formed by NC 45 at the south along Interstate 95 to Petersburg, 89), then due south to International Washington County line to U.S. 17 in then Route 460 (SE) to City of Suffolk, waters. Midway, U.S. 17 in Midway to U.S. 13 then south along Route 32 to the North Western Long Island Goose Area in Windsor, U.S. 13 in Windsor to the Carolina line. (NAP Low Harvest Area): The remainder Hertford Co. line), Camden, Chowan, SJBP Zone: The area to the west of the of the Long Island Waterfowl Hunting Currituck, Dare, Hyde, Pasquotank, AP Zone boundary and east of the Zone, excluding the Eastern Long Island Perquimans, Tyrrell, and Washington. following line: the ‘‘Blue Ridge’’ Goose Area, as defined above. (mountain spine) at the West Virginia- South Goose Area: The remainder of Pennsylvania Virginia Border (Loudoun County- New York State, excluding New York Resident Canada Goose Zone: All of Clarke County line) south to Interstate City. Pennsylvania except for Crawford, Erie, 64 (the Blue Ridge line follows county Special Late Canada Goose Area: That and Mercer counties and the area east of borders along the western edge of area of Westchester County lying route SR 97 from Maryland State Line Loudoun-Fauquier-Rappahannock- southeast of Interstate Route 95, and to the intersection of SR 194, east of SR Madison-Greene-Albemarle and into that area of Nassau and Suffolk Counties 194 to intersection of U.S. Route 30, Nelson Counties), then east along

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Interstate Rt. 64 to Route 15, then south Kentucky Bay, and from that point on a line along Rt. 15 to the North Carolina line. Western Zone: That portion of the directly northeast to the Canadian RP Zone: The remainder of the State State west of a line beginning at the border. SJBP Zone: The rest of the State, that west of the SJBP Zone. Tennessee State line at Fulton and area south and east of the boundary Back Bay Area: The waters of Back extending north along the Purchase described above. Bay and its tributaries and the marshes Parkway to Interstate Highway 24, east Tuscola/Huron Goose Management adjacent thereto, and on the land and along I–24 to U.S. Highway 641, north Unit (GMU): Those portions of Tuscola marshes between Back Bay and the along U.S. 641 to U.S. 60, northeast and Huron Counties bounded on the Atlantic Ocean from Sandbridge to the along U.S. 60 to the Henderson County south by Michigan Highway 138 and North Carolina line, and on and along line, then south, east, and northerly Bay City Road, on the east by Colwood the shore of North Landing River and along the Henderson County line to the and Bay Port Roads, on the north by the marshes adjacent thereto, and on Indiana State line. Kilmanagh Road and a line extending and along the shores of Binson Inlet Ballard Reporting Area: That area directly west off the end of Kilmanagh Lake (formerly known as Lake encompassed by a line beginning at the Road into Saginaw Bay to the west Tecumseh) and Red Wing Lake and the northwest city limits of Wickliffe in boundary, and on the west by the marshes adjacent thereto. Ballard County and extending westward Tuscola-Bay County line and a line to the middle of the Mississippi River, West Virginia extending directly north off the end of north along the Mississippi River and the Tuscola-Bay County line into Same zones as for ducks. along the low-water mark of the Ohio Saginaw Bay to the north boundary. Mississippi Flyway River on the Illinois shore to the Allegan County GMU: That area Ballard-McCracken County line, south encompassed by a line beginning at the Alabama along the county line to Kentucky junction of 136th Avenue and Interstate Same zones as for ducks, but in Highway 358, south along Kentucky 358 Highway 196 in Lake Town Township addition: to U.S. Highway 60 at LaCenter; then and extending easterly along 136th southwest along U.S. 60 to the northeast SJBP Zone: That portion of Morgan Avenue to Michigan Highway 40, city limits of Wickliffe. County east of U.S. Highway 31, north southerly along Michigan 40 through Henderson-Union Reporting Area: of State Highway 36, and west of U.S. the city of Allegan to 108th Avenue in Henderson County and that portion of 231; that portion of Limestone County Trowbridge Township, westerly along Union County within the Western Zone. south of U.S. 72; and that portion of 108th Avenue to 46th Street, northerly Pennyroyal/Coalfield Zone: Butler, Madison County south of Swancott ( mile along 46th Street to 109th Daviess, Ohio, Simpson, and Warren Road and west of Triana Road. Avenue, westerly along 109th Avenue to Counties and all counties lying west to I–196 in Casco Township, then Arkansas the boundary of the Western Goose northerly along I–196 to the point of Zone. Northwest Zone: Baxter, Benton, beginning. Boone, Carroll, Conway, Crawford, Michigan Saginaw County GMU: That portion of Saginaw County bounded by Faulkner, Franklin, Johnson, Logan, MVP–Upper Peninsula Zone: The Michigan Highway 46 on the north; Madison, Marion, Newton, Perry, Pope, MVP–Upper Peninsula Zone consists of Michigan 52 on the west; Michigan 57 Pulaski, Searcy, Sebastian, Scott, Van the entire Upper Peninsula of Michigan. on the south; and Michigan 13 on the Buren, Washington, and Yell Counties. MVP–Lower Peninsula Zone: The east. Illinois MVP–Lower Peninsula Zone consists of Muskegon Wastewater GMU: That the area within the Lower Peninsula of Same zones as for ducks. portion of Muskegon County within the Michigan that is north and west of the boundaries of the Muskegon County Indiana point beginning at the southwest corner wastewater system, east of the of Branch county, north continuing Same zones as for ducks, but in Muskegon State Game Area, in sections along the western border of Branch and 5, 6, 7, 8, 17, 18, 19, 20, 29, 30, and 32, addition: Calhoun counties to the northwest SJBP Zone: Jasper, LaGrange, LaPorte, T10N R14W, and sections 1, 2, 10, 11, corner of Calhoun county, then east to 12, 13, 14, 24, and 25, T10N R15W, as Starke, Elkhart, and Steuben Counties, the southwest corner of Eaton county, and that portion of the Jasper-Pulaski posted. then north to the southern border of Special Canada Goose Seasons: Fish and Wildlife Area in Pulaski Ionia county, then east to the southwest Southern Michigan Late Season County. corner of Clinton county, then north Canada Goose Zone: Same as the South Indiana Late Canada Goose Season along the western border of Clinton Duck Zone excluding Tuscola/Huron Zone: That part of the state County continuing north along the Goose Management Unit (GMU), encompassed by the following counties: county border of Gratiot and Montcalm Allegan County GMU, Saginaw County Steuben, Lagrange, Elkhart, St. Joseph, counties to the southern border of GMU, and Muskegon Wastewater GMU. La Porte, Starke, Marshall, Kosciusko, Isabella county, then east to the Noble, De Kalb, Allen, Whitley, southwest corner of Midland county, Minnesota Huntington, Wells, Adams, Boone, then north along the west Midland West Zone: That portion of the State Hamilton, Madison, Hendricks, Marion, county border to Highway M–20, then encompassed by a line beginning at the Hancock, Morgan, Johnson, Shelby, easterly to U.S. Highway 10, then junction of State Trunk Highway (STH) Vermillion, Parke, Vigo, Clay, Sullivan, easterly to U.S. Interstate 75/U.S. 60 and the Iowa State line, then north and Greene. Highway 23, then northerly along I–75/ and east along STH 60 to U.S. Highway Iowa U.S. 23 and easterly on U.S. 23 to the 71, north along U.S. 71 to Interstate centerline of the Au Gres River, then Highway 94, then north and west along North Zone: That portion of the State southerly along the centerline of the Au I–94 to the North Dakota State line. north of U.S. Highway 20. Gres River to Saginaw Bay, then on a West Central Zone: That area South Zone: The remainder of Iowa. line directly east 10 miles into Saginaw encompassed by a line beginning at the

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intersection of State Trunk Highway Lake Erie SJBP Zone: That portion of easterly along Poplar Grove Road to (STH) 29 and U.S. Highway 212 and the State encompassed by a line Rockea Road, southerly along Rockea extending west along U.S. 212 to U.S. beginning in Lucas County at the Road to County Highway JJ, 59, south along U.S. 59 to STH 67, west Michigan State line on I–75, and southeasterly along County JJ to Collins along STH 67 to U.S. 75, north along extending south along I–75 to I–280, Road, southerly along Collins Road to U.S. 75 to County State Aid Highway south along I–280 to I–80, east along I– the Manitowoc River, southeasterly (CSAH) 30 in Lac qui Parle County, west 80 to the Pennsylvania State line in along the Manitowoc River to Quarry along CSAH 30 to the western boundary Trumbull County, north along the Road, northerly along Quarry Road to of the State, north along the western Pennsylvania State line to SR 6 in Einberger Road, northerly along boundary of the State to a point due Ashtabula County, west along SR 6 to Einberger Road to Moschel Road, south of the intersection of STH 7 and the Lake/Cuyahoga County line, north westerly along Moschel Road to Collins CSAH 7 in Big Stone County, and along the Lake/Cuyahoga County line to Marsh Road, northerly along Collins continuing due north to said the shore of Lake Erie. Marsh Road to Hilltop Road. intersection, then north along CSAH 7 Tennessee Exterior Zone: That portion of the to CSAH 6 in Big Stone County, east State not included in the Horicon or along CSAH 6 to CSAH 21 in Big Stone Southwest Zone: That portion of the Collins Zones. County, south along CSAH 21 to CSAH State south of State Highways 20 and Mississippi River Subzone: That area 10 in Big Stone County, east along 104, and west of U.S. Highways 45 and encompassed by a line beginning at the CSAH 10 to CSAH 22 in Swift County, 45W. intersection of the Burlington Northern east along CSAH 22 to CSAH 5 in Swift Northwest Zone: Lake, Obion, and & Santa Fe Railway and the Illinois County, south along CSAH 5 to U.S. 12, Weakley Counties and those portions of State line in Grant County and east along U.S. 12 to CSAH 17 in Swift Gibson and Dyer Counties not included extending northerly along the County, south along CSAH 17 to CSAH in the Southwest Tennessee Zone. Burlington Northern & Santa Fe Railway 9 in Chippewa County, south along Kentucky/Barkley Lakes Zone: That to the city limit of Prescott in Pierce CSAH 9 to STH 40, east along STH 40 portion of the State bounded on the County, then west along the Prescott to STH 29, then south along STH 29 to west by the eastern boundaries of the city limit to the Minnesota State line. the point of beginning. Northwest and Southwest Zones and on Rock Prairie Subzone: That area Special Canada Goose Seasons: the east by State Highway 13 from the encompassed by a line beginning at the Southeast Zone: That part of the State Alabama State line to Clarksville and intersection of the Illinois State line and within the following described U.S. Highway 79 from Clarksville to the Interstate Highway 90 and extending boundaries: beginning at the Kentucky State line. north along I–90 to County Highway A, intersection of U.S. Highway 52 and the Wisconsin east along County A to U.S. Highway 12, south boundary of the Twin Cities southeast along U.S. 12 to State Same zones as for ducks but in Metro Canada Goose Zone; thence along Highway 50, west along State 50 to State addition: the U.S. Highway 52 to State Trunk Horicon Zone: That area encompassed 120, then south along 120 to the Illinois Highway (STH) 57; thence along STH 57 by a line beginning at the intersection of State line. to the municipal boundary of Kasson; State Highway 21 and the Fox River in Brown County Subzone: That area thence along the municipal boundary of Winnebago County and extending encompassed by a line beginning at the Kasson County State Aid Highway westerly along State 21 to the west intersection of the Fox River with Green (CSAH) 13, Dodge County; thence along boundary of Winnebago County, Bay in Brown County and extending CSAH 13 to STH 30; thence along STH southerly along the west boundary of southerly along the Fox River to State 30 to U.S. Highway 63; thence along Winnebago County to the north Highway 29, northwesterly along State U.S. Highway 63 to the south boundary boundary of Green Lake County, 29 to the Brown County line, south, of the State; thence along the south and westerly along the north boundaries of east, and north along the Brown County east boundaries of the State to the south Green Lake and Marquette Counties to line to Green Bay, due west to the boundary of the Twin Cities Metro State 22, southerly along State 22 to midpoint of the Green Bay Ship Canada Goose Zone; thence along said State 33, westerly along State 33 to Channel, then southwesterly along the boundary to the point of beginning. Interstate Highway 39, southerly along Green Bay Ship Channel to the Fox Missouri Interstate Highway 39 to Interstate River. Same zones as for ducks but in Highway 90/94, southerly along I–90/94 Central Flyway to State 60, easterly along State 60 to addition: Colorado (Central Flyway Portion) Middle Zone State 83, northerly along State 83 to Southeast Zone: That portion of the State 175, northerly along State 175 to Northern Front Range Area: All areas State encompassed by a line beginning State 33, easterly along State 33 to U.S. in Boulder, Larimer and Weld Counties at the intersection of Missouri Highway Highway 45, northerly along U.S. 45 to from the Continental Divide east along (MO) 34 and Interstate 55 and extending the east shore of the Fond Du Lac River, the Wyoming border to U.S. 85, south south along I–55 to U.S. Highway 62, northerly along the east shore of the on U.S. 85 to the Adams County line, west along U.S. 62 to MO 53, north Fond Du Lac River to Lake Winnebago, and all lands in Adams, Arapahoe, along MO 53 to MO 51, north along MO northerly along the western shoreline of Broomfield, Clear Creek, Denver, 51 to U.S. 60, west along U.S. 60 to MO Lake Winnebago to the Fox River, then Douglas, Gilpin, and Jefferson Counties. 21, north along MO 21 to MO 72, east westerly along the Fox River to State 21. North Park Area: Jackson County. along MO 72 to MO 34, then east along Collins Zone: That area encompassed South Park and San Luis Valley Area: MO 34 to I–55. by a line beginning at the intersection of All of Alamosa, Chaffee, Conejos, Hilltop Road and Collins Marsh Road in Costilla, Custer, Fremont, Lake, Park, Ohio Manitowoc County and extending Rio Grande and Teller Counties, and Same zones as for ducks but in westerly along Hilltop Road to Humpty those portions of Saguache, Mineral and addition: Dumpty Road, southerly along Humpty Hinsdale Counties east of the North Zone Dumpty Road to Poplar Grove Road, Continental Divide.

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Remainder: Remainder of the Central of U.S. 281 and U.S. 30 at Grand Island, and Weston Counties, and that portion Flyway portion of Colorado. north and east on U.S. 30 to NE 14, of Carbon County east of the Continental Eastern Colorado Late Light Goose south to NE 66, east to U.S. 81, north to Divide; that portion of Park County west Area: That portion of the State east of NE 92, east on NE 92 to NE 15, south of the Shoshone National Forest Interstate Highway 25. on NE 15 to NE 4, west on NE 4 to U.S. boundary, and that portion of Park County north of a line beginning where Nebraska 281, north on U.S. 281 to the beginning. Remainder of State: The remainder the Shoshone National Forest boundary Dark Geese portion of Nebraska. crosses Park County Road 8VC, easterly Niobrara Unit: That area contained along said road to Park County Road within and bounded by the intersection New Mexico (Central Flyway Portion) 1AB, easterly along said road to of the South Dakota State line and the Dark Geese Wyoming Highway 120, northerly along Cherry County line, south along the Middle Rio Grande Valley Unit: said highway to Wyoming Highway 294, Cherry County line to the Niobrara Sierra, Socorro, and Valencia Counties. southeasterly along said highway to River, east to the Norden Road, south on Remainder: The remainder of the Lane 9, easterly along said lane to the the Norden Road to U.S. Hwy 20, east Central Flyway portion of New Mexico. town of Powel and Wyoming Highway along U.S. Hwy 20 to NE Hwy 137, South Dakota 14A, easterly along said highway to the north along NE Hwy 137 to the Niobrara Park County and Big Horn County Line. River, east along the Niobrara River to Canada Geese Area 3: Goshen and Platte Counties. the Boyd County line, north along the Unit 1: Remainder of South Dakota. Area 4: Big Horn and Fremont Boyd County line to the South Dakota Unit 2: Bon Homme, Brule, Buffalo, Counties. State line. Where the Niobrara River Charles Mix, Custer east of SD Hwy 79 Pacific Flyway forms the boundary, both banks of the and south of French Creek, Dewey south river are included in the Niobrara Unit. of U.S. Hwy 212, Fall River east of SD Arizona East Unit: That area north and east of Hwy 71 and U.S. Hwy 385, Gregory, North Zone: Game Management Units U.S. 281 at the Kansas-Nebraska State Hughes, Hyde south of U.S. Hwy 14, 1–5, those portions of Game line, north to Giltner Road (near Lyman, Potter west of U.S. Hwy 83, Management Units 6 and 8 within Doniphan), east to NE 14, north to NE Stanley, and Sully Counties. Coconino County, and Game 66, east to U.S. 81, north to NE 22, west Unit 3: Bennett County. Management units 7, 9, and 12A. to NE 14 north to NE 91, east to U.S. Texas South Zone: Those portions of Game 275, south to U.S. 77, south to NE 91, Management Units 6 and 8 in Yavapai east to U.S. 30, east to Nebraska-Iowa Northeast Goose Zone: That portion of County, and Game Management Units State line. Texas lying east and north of a line 10 and 12B–45. Platte River Unit: That area south and beginning at the Texas-Oklahoma border west of U.S. 281 at the Kansas-Nebraska at U.S. 81, then continuing south to California State line, north to Giltner Road (near Bowie and then southeasterly along U.S. Northeastern Zone: In that portion of Doniphan), east to NE 14, north to NE 81 and U.S. 287 to I–35W and I–35 to California lying east and north of a line 66, east to U.S. 81, north to NE 22, west the juncture with I–10 in San Antonio, beginning at the intersection of to NE 14, north to NE 91, west along NE then east on I–10 to the Texas-Louisiana Interstate 5 with the California-Oregon 91 to NE 11, north to the Holt County border. line; south along Interstate 5 to its line, west along the northern border of Southeast Goose Zone: That portion of junction with Walters Lane south of the Garfield, Loup, Blaine and Thomas Texas lying east and south of a line town of Yreka; west along Walters Lane Counties to the Hooker County line, beginning at the International Toll to its junction with Easy Street; south south along the Thomas-Hooker County Bridge at Laredo, then continuing north along Easy Street to the junction with lines to the McPherson County line, east following I–35 to the juncture with I–10 Old Highway 99; south along Old along the south border of Thomas in San Antonio, then easterly along I– Highway 99 to the point of intersection County to the western line of Custer 10 to the Texas-Louisiana border. with Interstate 5 north of the town of County, south along the Custer-Logan West Goose Zone: The remainder of Weed; south along Interstate 5 to its County line to NE 92, west to U.S. 83, the State. junction with Highway 89; east and north to NE 92, west to NE 61, north Wyoming (Central Flyway Portion) south along Highway 89 to main street along NE 61 to NE 2, west along NE 2 Greenville; north and east to its junction to the corner formed by Garden-Grant- Dark Geese with North Valley Road; south to its Sheridan Counties, west along the north Area 1: Converse, Hot Springs, junction of Diamond Mountain Road; border of Garden, Morrill, and Scotts Natrona, and Washakie Counties, and north and east to its junction with North Bluff Counties to the intersection of the the portion of Park County east of the Arm Road; south and west to the Interstate Canal, west to Wyoming State Shoshone National Forest boundary and junction of North Valley Road; south to line. south of a line beginning where the the junction with Arlington Road (A22); North-Central Unit: The remainder of Shoshone National Forest boundary west to the junction of Highway 89; the State. crosses Park County Road 8VC, easterly south and west to the junction of Light Geese along said road to Park County Road Highway 70; east on Highway 70 to Rainwater Basin Light Goose Area 1AB, easterly along said road to Highway 395; south and east on (West): The area bounded by the Wyoming Highway 120, northerly along Highway 395 to the point of intersection junction of U.S. 283 and U.S. 30 at said highway to Wyoming Highway 294, with the California-Nevada State line; Lexington, east on U.S. 30 to U.S. 281, southeasterly along said highway to north along the California-Nevada State south on U.S. 281 to NE 4, west on NE Lane 9, easterly along said lane to the line to the junction of the California- 4 to U.S. 34, continue west on U.S. 34 town of Powel and Wyoming Highway Nevada-Oregon State lines west along to U.S. 283, then north on U.S. 283 to 14A, easterly along said highway to the the California-Oregon State line to the the beginning. Park County and Big Horn County Line. point of origin. Rainwater Basin Light Goose Area Area 2: Albany, Campbell, Crook, Colorado River Zone: Those portions (East): The area bounded by the junction Johnson, Laramie, Niobrara, Sheridan, of San Bernardino, Riverside, and

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Imperial Counties east of a line south on I–5 to Hahn Road; easterly on New Mexico (Pacific Flyway Portion) extending from the Nevada border south Hahn Road and the Grimes–Arbuckle North Zone: The Pacific Flyway along U.S. 95 to Vidal Junction; south Road to Grimes; northerly on CA 45 to portion of New Mexico located north of on a road known as ‘‘Aqueduct Road’’ the junction with CA 162; northerly on I–40. in San Bernardino County through the CA 45/162 to Glenn; and westerly on South Zone: The Pacific Flyway town of Rice to the San Bernardino- CA 162 to the point of beginning in portion of New Mexico located south of Riverside County line; south on a road Willows. I–40. known in Riverside County as the ‘‘Desert Center to Rice Road’’ to the Colorado (Pacific Flyway Portion) Oregon town of Desert Center; east 31 miles on West Central Area: Archuleta, Delta, Southwest Zone: Those portions of I–10 to the Wiley Well Road; south on Dolores, Gunnison, LaPlata, Douglas, Coos, and Curry Counties east this road to Wiley Well; southeast along Montezuma, Montrose, Ouray, San Juan, of Highway 101, and Josephine and the Army-Milpitas Road to the Blythe, and San Miguel Counties and those Jackson Counties. Brawley, Davis Lake intersections; south portions of Hinsdale, Mineral, and South Coast Zone: Those portions of on the Blythe-Brawley paved road to the Saguache Counties west of the Douglas, Coos, and Curry Counties west Ogilby and Tumco Mine Road; south on Continental Divide. of Highway 101. this road to U.S. 80; east 7 miles on U.S. State Area: The remainder of the Northwest Special Permit Zone: That 80 to the Andrade-Algodones Road; Pacific–Flyway Portion of Colorado. portion of western Oregon west and south on this paved road to the Mexican north of a line running south from the Idaho border at Algodones, Mexico. Columbia River in Portland along I–5 to Southern Zone: That portion of Zone 1: Benewah, Bonner, Boundary, OR 22 at Salem; then east on OR 22 to southern California (but excluding the Clearwater, Idaho, Kootenai, Latah, the Stayton Cutoff; then south on the Colorado River Zone) south and east of Lewis, Nez Perce, and Shoshone Stayton Cutoff to Stayton and due south a line extending from the Pacific Ocean to the Santiam River; then west along east along the Santa Maria River to CA Counties. 166 near the City of Santa Maria; east on Zone 2: The Counties of Ada; Adams; the north shore of the Santiam River to CA 166 to CA 99; south on CA 99 to the Boise; Canyon; those portions of Elmore I–5; then south on I–5 to OR 126 at crest of the Tehachapi Mountains at north and east of I–84, and south and Eugene; then west on OR 126 to Tejon Pass; east and north along the west of I–84, west of ID 51, except the Greenhill Road; then south on Greenhill crest of the Tehachapi Mountains to CA Camas Creek drainage; Gem; Owyhee Road to Crow Road; then west on Crow 178 at Walker Pass; east on CA 178 to west of ID 51; Payette; Valley; and Road to Territorial Hwy; then west on U.S. 395 at the town of Inyokern; south Washington. Territorial Hwy to OR 126; then west on on U.S. 395 to CA 58; east on CA 58 to Zone 3: The Counties of Cassia except OR 126 to Milepost 19, north to the I–15; east on I–15 to CA 127; north on the Minidoka National Wildlife Refuge; intersection of the Benton and Lincoln CA 127 to the Nevada border. those portions of Elmore south of I–84 County line, north along the western Imperial County Special Management east of ID 51, and within the Camas boundary of Benton and Polk Counties Area: The area bounded by a line Creek drainage; Gooding; Jerome; to the southern boundary of Tillamook beginning at Highway 86 and the Navy Lincoln; Minidoka; Owyhee east of ID County, west along the Tillamook Test Base Road; south on Highway 86 to 51; and Twin Falls. County boundary to the Pacific Coast. Lower Columbia/N. Willamette Valley the town of Westmoreland; continue Zone 4: The Counties of Bear Lake; Management Area: Those portions of through the town of Westmoreland to Bingham within the Blackfoot Reservoir Clatsop, Columbia, Multnomah, and Route S26; east on Route S26 to drainage; Blaine; Camas; Bonneville, Washington Counties within the Highway 115; north on Highway 115 to Butte; Caribou except the Fort Hall Northwest Special Permit Zone. Weist Rd.; north on Weist Rd. to Indian Reservation; Cassia within the Tillamook County Management Area: Flowing Wells Rd.; northeast on Minidoka National Wildlife Refuge; All of Tillamook County is open to Flowing Wells Rd. to the Coachella Clark; Custer; Franklin; Fremont; goose hunting except for the following Canal; northwest on the Coachella Canal Jefferson; Lemhi; Madison; Oneida; and area—beginning in Cloverdale at Hwy to Drop 18; a straight line from Drop 18 Teton. to Frink Rd.; south on Frink Rd. to 101, west on Old Woods Rd to Sand Zone 5: All lands and waters within Lake Rd at Woods, north on Sand Lake Highway 111; north on Highway 111 to the Fort Hall Indian Reservation, Niland Marina Rd.; southwest on Niland Rd to the intersection with McPhillips including private inholdings; Bannock Dr, due west (∼200 yards) from the Marina Rd. to the old Imperial County County; Bingham County, except that boat ramp and the water line of the intersection to the Pacific coastline, portion within the Blackfoot Reservoir south on the Pacific coastline to Salton Sea; from the water line of the drainage; and Power County. Salton Sea, a straight line across the Neskowin Creek, east along the north Salton Sea to the Salinity Control Montana (Pacific Flyway Portion) shores of Neskowin Creeks and then Hawk Creeks to Salem Ave, east on Research Facility and the Navy Test East of the Divide Zone: The Pacific Base Road; southwest on the Navy Test Salem Ave in Neskowin to Hawk Ave, Flyway portion of the State located east east on Hawk Ave to Hwy 101, north on Base Road to the point of beginning. of the Continental Divide. Balance-of-the-State Zone: The Hwy 101 at Cloverdale, point of remainder of California not included in West of the Divide Zone: The beginning. the Northeastern, Southern, and the remainder of the Pacific Flyway portion Northwest Zone: Those portions of Colorado River Zones. of Montana. Clackamas, Lane, Linn, Marion, North Coast Special Management Nevada Multnomah, and Washington Counties Area: The Counties of Del Norte and outside of the Northwest Special Permit Humboldt. Lincoln Clark County Zone: All of Zone and all of Lincoln County. Sacramento Valley Special Lincoln and Clark Counties. Eastern Zone: Hood River, Wasco, Management Area (West): That area Remainder-of-the-State Zone: The Sherman, Gilliam, Morrow, Umatilla, bounded by a line beginning at Willows remainder of Nevada. Deschutes, Jefferson, Crook, Wheeler,

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Grant, Baker, Union, and Wallowa Washington Codington, Davison, Deuel, Day, Counties. Area 1: Skagit, Island, and Snohomish Edmunds, Faulk, Grant, Hamlin, Hand, Harney, Lake, and Malheur County Counties. Hanson, Hughes, Hyde, Jerauld, Zone: All of Harney, Lake, and Malheur Area 2A (SW Quota Zone): Clark Kingsbury, Lake, Marshall, McCook, Counties. County, except portions south of the McPherson, Miner, Minnehaha, Moody, Potter, Roberts, Sanborn, Spink, Sully, Klamath County Zone: All of Klamath Washougal River; Cowlitz, and and Walworth Counties. County. Wahkiakum Counties. Area 2B (SW Quota Zone): Pacific Pacific Flyway Utah County. Area 3: All areas west of the Pacific Montana (Pacific Flyway Portion) Northern Utah Zone: All of Cache and Crest Trail and west of the Big White Open Area: Cascade, Chouteau, Hill, Rich Counties, and that portion of Box Salmon River that are not included in Liberty, and Toole Counties and those Elder County beginning at I–15 and the Areas 1, 2A, and 2B. Weber-Box Elder County line; east and Area 4: Adams, Benton, Chelan, portions of Pondera and Teton Counties north along this line to the Weber-Cache Douglas, Franklin, Grant, Kittitas, lying east of U.S. 287–89. County line; east along this line to the Lincoln, Okanogan, Spokane, and Walla Nevada Cache-Rich County line; east and south Walla Counties. along the Rich County line to the Utah- Area 5: All areas east of the Pacific Open Area: Churchill, Lyon, and Wyoming State line; north along this Crest Trail and east of the Big White Pershing Counties. line to the Utah-Idaho State line; west Salmon River that are not included in Utah on this line to Stone, Idaho-Snowville, Area 4. Utah road; southwest on this road to Open Area: Those portions of Box Locomotive Springs Wildlife Brant Elder, Weber, Davis, Salt Lake, and Management Area; east on the county Pacific Flyway Toole Counties lying west of I–15, north road, past Monument Point and across of I–80 and south of a line beginning California Salt Wells Flat, to the intersection with from the Forest Street exit to the Bear Promontory Road; south on Promontory North Coast Zone: Del Norte, River National Wildlife Refuge Road to a point directly west of the Humboldt and Mendocino Counties. boundary, then north and west along the northwest corner of the Bear River South Coast Zone: Balance of the Bear River National Wildlife Refuge Migratory Bird Refuge boundary; east State. boundary to the farthest west boundary of the Refuge, then west along a line to along an imaginary line to the northwest Washington corner of the Refuge boundary; south Promontory Road, then north on and east along the Refuge boundary to Puget Sound Zone: Skagit County. Promontory Road to the intersection of Coastal Zone: Pacific County. the southeast corner of the boundary; SR 83, then north on SR 83 to I–84, then northeast along the boundary to the Swans north and west on I–84 to State Hwy 30, then west on State Hwy 30 to the Perry access road; east on the Perry Central Flyway access road to I–15; south on I–15 to the Nevada–Utah State line, then south on Weber-Box Elder County line. South Dakota: the Nevada–Utah State line to I–80. Remainder-of-the-State Zone: The Aurora, Beadle, Brookings, Brown, [FR Doc. E7–18546 Filed 9–19–07; 8:45 am] remainder of Utah. Brule, Buffalo, Campbell, Clark, BILLING CODE 4310–55–P

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Part VII

Department of Justice Drug Enforcement Administration

Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2007 and 2008; Notices

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DEPARTMENT OF JUSTICE for the List I Chemicals Ephedrine, distributors, and retailers, and a law Pseudoephedrine, and firm representing an OTC product Drug Enforcement Administration Phenylpropanolamine for 2007: manufacturer. [Docket No. DEA–300F] Proposed’’ was published in the Federal The fifth commenter requested that Register (71 FR 61801). This notice DEA consider its proposed individual Established Assessment of Annual proposed the initial 2007 assessment of requirement for ephedrine in fixing the Needs for the List I Chemicals annual needs for ephedrine (for sale), final assessment of annual needs. Ephedrine, Pseudoephedrine, and ephedrine (for conversion), DEA did not receive any comments on Phenylpropanolamine for 2007 pseudoephedrine (for sale), its proposed assessment of annual needs phenylpropanolamine (for sale) and for ephedrine (for conversion) and AGENCY: Drug Enforcement phenylpropanolamine (for conversion). phenylpropanolamine (for sale) and is Administration (DEA), Justice. All interested persons were invited to therefore finalizing these values as ACTION: Notice of assessment of annual comment on or object to the proposed proposed. The assessment of annual needs for 2007. assessments on or before December 4, needs for phenylpropanolamine (for 2006. conversion), ephedrine (for sale) and SUMMARY: This notice establishes the pseudoephedrine (for sale) are initial year 2007 assessment of annual Comments Received discussed below within the context of needs for certain List I chemicals in DEA received eight comments from the comments received. accordance with the Combat five interested parties during the Comments Regarding DEA’s Proposed Methamphetamine Epidemic Act of comment period. Two comments were Assessment for Phenylpropanolamine 2005 (CMEA), enacted on March 9, received from two DEA registered (for Conversion) 2006. chemical importers; one comment was One commenter, a manufacturer that DATES: Effective Date: September 20, received from a DEA registered 2007. chemical manufacturer; two comments imports phenylpropanolamine, were received from an association considered the proposed FOR FURTHER INFORMATION CONTACT: representing over-the-counter (OTC) phenylpropanolamine (for conversion) Christine A. Sannerud, Ph.D., Chief, manufacturers, distributors and assessment, i.e., the amount necessary Drug & Chemical Evaluation Section, retailers; and three comments were for the manufacture of other substances, Drug Enforcement Administration, received from a law firm representing an insufficient to meet its customers’ Washington, DC 20537, Telephone: OTC product manufacturer. After the needs. The commenter stated that (202) 307–7183. comment period closed, DEA received phenylpropanolamine, and its isomers, SUPPLEMENTARY INFORMATION: an additional comment from the above- are used as chiral agents in numerous chemical syntheses, a factor that the Background and Legal Authority mentioned association. All comments received during the comment period are commenter believed DEA had not Section 713 of the CMEA (Title VII of summarized here and discussed further considered in its original proposal. The Pub. L 109–177) amended section 306 of below. commenter stated that the synthesized the Controlled Substances Act (CSA) (21 One of the five commenters supported drugs are used in drug products U.S.C. 826) requiring that the Attorney the DEA’s proposal. This commenter, administered to patients with Acquired General establish quotas to provide for one of the DEA registered chemical Immune Deficiency Syndrome (AIDS) the annual needs for ephedrine, importers, stated that DEA’s proposed and Attention Deficit Disorder (ADD). pseudoephedrine, and assessment of annual needs for This commenter believed that these uses phenylpropanolamine. Further, section pseudoephedrine and ephedrine was are probably the largest use of 715 of the CMEA amended 21 U.S.C. ‘‘reasonable.’’ Additionally, the phenylpropanolamine. 952 by adding ephedrine, commenter requested that the DEA DEA had considered in its proposal pseudoephedrine, and consider providing ‘‘regulatory relief’’ the amount of phenylpropanolamine it phenylpropanolamine to the existing with regard to the new import believed was necessary for the language concerning importation of provisions by minimizing the amount of manufacture of ADD medicines, but had controlled substances. information that will be required on the not considered the chemical’s use in the The 2007 assessment of annual needs import applications and relying more manufacture of drugs utilized in the represents those quantities of ephedrine, heavily on the requirements under the treatment of AIDS. After consideration pseudoephedrine, and ‘‘spot market’’ provision to ensure that of this comment along with additional phenylpropanolamine which may be these substances are imported for information obtained by DEA in manufactured domestically and/or legitimate needs. Since the information connection with this comment, DEA has imported into the United States in 2007 collected as part of the quota provisions adjusted its assessment for to provide adequate supplies of each and import applications is not the phenylpropanolamine (for conversion) chemical for: the estimated medical, subject of this notice, the latter part of from 6,240 kg to 85,470 kg. scientific, research and industrial needs this comment was not considered by of the United States; lawful export DEA. Comments Regarding DEA’s Proposed requirements; and the establishment Three of the five commenters raised Assessments for Ephedrine (for Sale) and maintenance of reserve stocks. concerns regarding DEA’s proposal. and Pseudoephedrine (for Sale) This responsibility for establishing Two of these commenters raised Two commenters, the association the assessment has been delegated to the concerns regarding the assessment for representing OTC manufacturers, Administrator of the DEA by 28 CFR ephedrine while one raised concerns distributors, and retailers, and the law section 0.100. The Administrator, in regarding the assessment for firm representing an OTC product turn, has redelegated this function to the phenylpropanolamine (for conversion). manufacturer, indicated their belief that Deputy Administrator, pursuant to 28 These commenters included a DEA- the proposed ephedrine assessment was CFR section 0.104. registered manufacturer that imports insufficient to meet market demands for On October 19, 2006, a notice phenylpropanolamine, an association ephedrine-containing OTC products. entitled, ‘‘Assessment of Annual Needs representing OTC manufacturers, The association also questioned the

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sufficiency of the assessment for DEA notes that IMS completed a report is discussed below and is pseudoephedrine. sensitivity analysis upon review of the available on DEA’s Office of Diversion The law firm representing an OTC comments submitted by this Control Web site, http:// product manufacturer submitted three commenter. The results of this analysis www.deadiversion.usdoj.gov. and DEA’s consideration of the results individual comments during the Report Prepared by IMS Health comment period. The first comment of that analysis are discussed below. requested a 30-day extension of the IMS’ final report is available on the As discussed in its October 19, 2006, comment period. The commenter stated Office of Diversion Control’s Web site proposed Assessment of Annual Needs, since the manufacture and importation that they were unable to locate the IMS (http://www.deadiversion.usdoj.gov). of ephedrine, pseudoephedrine, and Health Government Solutions (IMS) The association representing OTC phenylpropanolamine were not report on the DEA Diversion Web site. manufacturers, distributors, and previously regulated through the The commenter was contacted by DEA retailers provided two comments to the establishment of an assessment of and advised as to where the IMS report docket during the comment period. The annual needs, DEA obtained assistance was located; upon locating the report, commenter stated that the IMS report from a private independent contractor, the commenter withdrew their request did not ‘‘properly document data from IMS, to develop the initial estimate of for a 30-day extension. The second the convenience store segment.’’ The the medical needs of the United States comment was another request for a 30- commenter noted its concern that DEA of ephedrine and pseudoephedrine. day extension of the comment period has ‘‘narrowly defined ‘medical need’’’ for preparations containing these List I IMS’ estimates of medical needs for deadline in order to compile and submit chemicals, specifically ephedrine. The ephedrine and pseudoephedrine were to DEA a report from ‘‘* * * experts in commenter stated that it had derived from data the company medicine, economics, and DEA/law commissioned ‘‘a study by an outside routinely collects and offers to enforcement to assess the impact of the economic consulting firm to provide the customers to understand the proposed quota on medical, industrial, DEA with substantive information that pharmaceutical market. For this scientific and other legitimate demand would help DEA produce a more analysis, IMS utilized the following for the two chemical substances.’’ The accurate and substantive estimate of types of data: (1) Sales to retail commenter submitted the report to DEA ephedrine needs assessment for 2007.’’ establishments (including pharmacies), in its third comment. The commenter The comment included a request for an (2) sales by retail establishments to recommended ‘‘withdrawal of the extension of time which was not patients, and (3) medical insurance proposed 2007 assessment due to its granted. The study was submitted to claims. IMS’ estimates of medical needs inaccuracy and incompleteness.’’ The both DEA and IMS after the comment were intended to encompass only those commenter requested that DEA issue a period had closed. products containing either ephedrine or new notice. The comment made the In connection with the concerns pseudoephedrine, whether requiring a following conclusions: (1) That the IMS raised by these two commenters that the prescription or available over-the- report was flawed because it excluded preliminary IMS study did not counter. The estimates of use and underestimated ‘‘legitimate demand adequately address sales of ephedrine- encompassed those products containing for ephedrine sold in over-the-counter based OTC drug products through the ephedrine and pseudoephedrine which (OTC) drugs for respiratory ailments via convenience store channel of are lawfully marketed under the Federal convenience stores’’; (2) ‘‘The distribution, DEA notes that its contract Food, Drug and Cosmetic Act. As noted underestimation of legitimate medical with IMS had two distinct phases. Phase previously, IMS did not examine need will lead to ephedrine quota levels I, which was completed prior to estimates for phenylpropanolamine. beneath those necessary to ensure publication of the proposed assessment The CSA requires that DEA establish adequate supplies of ephedrine to treat of annual needs, involved a preliminary quotas for ephedrine, pseudoephedrine, respiratory ailments’’; (3) ‘‘The assessment of the medical use of and phenylpropanolamine to meet the exclusion of convenience stores from ephedrine and pseudoephedrine and a estimated medical, scientific, research, the IMS calculus and any resulting written summary of the methodology it and industrial needs of the United deprivation of supply to satisfy used to develop the estimates. This States, lawful export requirements, and legitimate demand in those stores will information was made available for maintenance of reserve stocks. imperil the health and safety of review by the public when the DEA Accordingly, DEA requested that IMS Americans with respiratory ailments, published the ‘‘Assessment of Annual determine the amount of ephedrine and resulting in increased hospitalization Needs for the List I Chemicals pseudoephedrine necessary to meet the and possibly deaths due to a lack of Ephedrine, Pseudoephedrine, and estimated medical needs of the United ready access in moments of critical Phenylpropanolamine for 2007: States. DEA and IMS agreed that looking need’’; (4) ‘‘* * * the prejudicial Proposed’’ (71 FR 61801). The second at sales of prescription and OTC drug exclusion of convenience store demand phase of DEA’s contract involved IMS’ products containing these list I from the 2007 Annual Needs estimate development of a final estimate which chemicals through all distribution not only reduces supply beneath safe was developed by IMS after channels alone would not be an levels but also creates an anti- consideration of all available appropriate proxy from which to derive competitive market bias in favor of information, including: comments an estimate of what IMS describes in its pharmacies over convenience stores to received from the public during the report as the ‘‘legitimate medical use’’ the economic and physical detriment of comment period, the study submitted because this approach would have the all with legitimate medical needs.’’ The directly to IMS by the association unwanted effect of including amounts of commenter also stated that IMS did not representing OTC manufacturers, ephedrine and pseudoephedrine conduct any ‘‘sensitivity tests, distributors and retailers, updated purchased for use in the clandestine assessments of bias, or estimates of information from the data sources used manufacture of methamphetamine. precision related to use of surveys that by IMS to compile the initial estimates, Therefore, IMS concluded that the are critical to estimates of certain and other available information on the best proxy for evaluating the estimated segments of the legitimate medical use sales of OTC drug products through medical use for these chemicals, i.e., the market, such as convenience stores.’’ various distribution channels. The final alternate method that seeks to exclude

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sales of ephedrine and stable from the simple average of the maintenance of reserve stocks. After pseudoephedrine-based products three component final estimates and, at considering IMS’ final estimate of the destined for clandestine most, differed by 7.7 percent. The medical need of ephedrine-based methamphetamine production in the decrease observed in IMS final estimate prescription and OTC products (5,998 United States, would involve evaluating as compared with the preliminary kg), along with information DEA the changes (increases or decreases) in estimate was due to a necessary collects from DEA registered chemical sales of prescription and OTC products adjustment resulting from IMS initially exporters (through the DEA–486 Import/ containing these List I chemicals which expressing its estimate (350,700 kg) in Export Declaration for Listed have resulted from various state terms of the compound weight, e.g., Chemicals), and amounts necessary to initiatives aimed at imposing pseudoephedrine hydrochloride, rather maintain reserve stocks, DEA has restrictions on the retail sales of OTC than expressing its estimate in terms of increased the ephedrine (for sale) drug products containing these the weight of the molecule assessment from 7,100 kg to 11,500 kg. chemicals. These state-sponsored pseudoephedrine alone. Overall, this Conclusion initiatives began as early as 2004. The resulted in a correction down in the IMS requirements vary from state to state, estimate by approximately 20 percent. Therefore, under the authority vested but examples include: (1) Placing OTC Although IMS’ final estimate is lower, in the Attorney General by section 306 products behind pharmacy counters, (2) DEA has concluded that the amount of the CSA (21 U.S.C. 826), and restricting the quantity of OTC drug proposed would allow for sufficient delegated to the Administrator of the products that could be purchased by inventory allowances to DEA registered DEA by 28 CFR section 0.100, and individuals, and (3) providing proof of manufacturers and importers of redelegated to the Deputy Administrator identification at the time of purchase. pseudoephedrine products and could pursuant to 28 CFR section 0.104, the Based on this analysis, IMS concluded account for any unexpected change Deputy Administrator hereby orders that the median changes in OTC sales of (increase) in the use of pseudoephedrine that the 2007 assessment of annual ephedrine products were: 23.7 percent that may result from changes in the needs for ephedrine, pseudoephedrine, increase through retail channels (mass acceptability of phenylephrine as a and phenylpropanolamine, expressed in merchandisers, grocery stores, etc.) and substitute for pseudoephedrine in many kilograms of anhydrous acid or base, be a 45.2 percent decrease in ‘‘other’’ OTC cough and cold products currently established as follows: distribution channels (including gas on the market. Final year 2007 station and convenience stores). For IMS’ Medical Need Estimate for List I chemicals assessment of comparison, sales of OTC products Ephedrine and the DEA’s Final 2007 annual needs containing pseudoephedrine decreased Assessment of Annual Needs for (kg) by 22 percent through retail distribution Ephedrine (for Sale) channels and also decreased by 10.8 Ephedrine (for sale) ...... 11,500 percent through other distribution As with the pseudoephedrine Ephedrine (for conver- channels. Accordingly, these changes, estimate, IMS based its preliminary sion) ...... 128,760 ephedrine medical need estimate on the Pseudoephedrine (for along with the changes observed in the sale) ...... 511,100 usage of prescription drug products weights of the salt forms of ephedrine; this resulted in a necessary adjustment Phenylpropanolamine (for containing ephedrine and sale) ...... 5,545 pseudoephedrine, were applied across down by 20 percent for its final medical Phenylpropanolamine (for all data systems used in the IMS need estimate. Unlike the conversion) ...... 85,470 analysis. pseudoephedrine estimate which Based on the comments analyzed by decreased in the final report, IMS’ The Office of Management and Budget IMS, IMS completed a sensitivity analysis of the data available resulted in has determined that notices of quotas analysis of their final estimates. IMS an increase from 3,800 kg to 4,096 kg. are not subject to centralized review concluded that the estimated medical Furthermore, the results of its under Executive Order 12866. use for pseudoephedrine was ‘‘very sensitivity analysis concluded that the This action does not preempt or stable * * * differing from the simple 4,096 kg medical need estimate was modify any provision of state law; nor average of the component final ‘‘unstable’’ as compared to the estimate does it impose enforcement estimates by at most 7.7%.’’ By contrast, for pseudoephedrine and that the responsibilities on any state; nor does it however, the estimated medical use for sensitivity estimates differed from the diminish the power of any state to ephedrine was ‘‘relatively unstable, as final estimate by as much as 46.5 enforce its own laws. Accordingly, this the sensitivity estimates differ from the percent (range was 4,096 kg to 5,998 kg). action does not have any federalism final estimate by as much as 46.5%.’’ The two factors principally responsible implications warranting the application for the 46.5 percent range were: (1) The of Executive Order 13132. IMS’ Medical Need Estimate for incorporation of estimated amounts of The Deputy Administrator hereby Pseudoephedrine and the DEA’s Final OTC products sold in convenience certifies that this action will have no 2007 Assessment of Annual Needs for stores, which IMS concluded to be 7.7 significant impact upon small entities Pseudoephedrine (for Sale) percent, and (2) the incorporation of whose interests must be considered In its final report, IMS concluded that ‘‘non-matched products,’’ i.e., those under the Regulatory Flexibility Act, 5 the estimated medical need for products not originally confirmed to U.S.C. 601–612. The establishment of pseudoephedrine decreased in all three contain ephedrine or pseudoephedrine, assessments of annual needs for models analyzed. The initial IMS report into IMS’ estimate. ephedrine, pseudoephedrine, and estimated that the medical need in the Based on this analysis, DEA phenylpropanolamine is mandated by United States for pseudoephedrine was concludes that the proposed assessment law. The assessments are necessary to 350,700 kg and in the final report the of annual needs for ephedrine (for sale) provide for the estimated medical, medical need estimate was 280,268 kg. was inadequate to meet the estimated scientific, research and industrial needs The results of the sensitivity analysis medical, scientific, research, and of the United States, for export suggest that the pseudoephedrine industrial needs of the United States, requirements, and the establishment medical need assessment was very lawful export requirements, and and maintenance of reserve stocks.

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Accordingly, the Deputy Administrator additional regulatory controls upon the (a) Controlled substances in schedule I or has determined that this action does not manufacture, distribution, importation, II and narcotic drugs in schedule III, IV, or require a regulatory flexibility analysis. and exportation of the three List I V; exceptions This action meets the applicable chemicals. It shall be unlawful to import into the customs territory of the United States from standards set forth in sections 3(a) and any place outside thereof (but within the 3(b)(2) of Executive Order 12988 Civil DATES: Written comments or objections must be postmarked, and electronic United States), or to import into the United Justice Reform. States from any place outside thereof, any This action will not result in the comments must be sent, on or before controlled substance in schedule I or II of expenditure by State, local, and tribal October 11, 2007. subchapter I of this chapter, or any narcotic governments, in the aggregate, or by the ADDRESSES: To ensure proper handling drug in schedule III, IV, or V of subchapter private sector, of $120,000,000 or more of comments, please reference ‘‘Docket I of this chapter, or ephedrine, pseudoephedrine, and (adjusted for inflation) in any one year, No. DEA–306’’ on all written and and will not significantly or uniquely phenylpropanolamine, except that— electronic correspondence. Written (1) Such amounts of crude opium, poppy affect small governments. Therefore, no comments being sent via regular mail straw, concentrate of poppy straw, and coca actions were deemed necessary under should be sent to the Deputy Assistant leaves, and of ephedrine, pseudoephedrine, the provisions of the Unfunded Administrator, Office of Diversion and phenylpropanolamine, as the Attorney Mandates Reform Act of 1995. Control, Drug Enforcement General finds to be necessary to provide for This action is not a major rule as Administration, Washington, DC 20537, medical, scientific, or other legitimate defined by section 804 of the Small Attention: DEA Federal Register purposes, and Business Regulatory Enforcement Representative/ODL. Written comments * * * * * Fairness Act of 1996 (Congressional sent via express mail should be sent to (d)(1) With respect to a registrant under Review Act). This action will not result DEA Headquarters, Attention: DEA Section 958 who is authorized under in an annual effect on the economy of Federal Register Representative/ODL, Subsection (a)(1) to import ephedrine, pseudoephedrine, or phenylpropanolamine, $100,000,000 or more; a major increase 2401 Jefferson-Davis Highway, in costs or prices; or significant adverse at any time during the year the registrant may Alexandria, VA 22301. Comments may apply for an increase in the amount of such effects on competition, employment, be directly sent to DEA electronically by chemical that the registrant is authorized to investment, productivity, innovation, or sending an electronic message to import, and the Attorney General may on the ability of United States-based [email protected]. DEA approve the application if the Attorney companies to compete with foreign- will accept attachments to electronic General determines that the approval is based companies in domestic and comments in Microsoft Word, necessary to provide for medical, scientific, export markets. WordPerfect, Adobe PDF, or Excel file or other legitimate purposes regarding the chemical. Dated: September 13, 2007. formats only. DEA will not accept any Michele M. Leonhart, file format other than those specifically Editor’s Note: This excerpt of the amendment is published for the convenience Deputy Administrator. listed here. of the reader. The official text is published [FR Doc. E7–18523 Filed 9–19–07; 8:45 am] FOR FURTHER INFORMATION CONTACT: at 21 U.S.C. 952(a) and (d)(1). BILLING CODE 4410–09–P Christine A. Sannerud, PhD, Chief, Drug The responsibility for establishing the and Chemical Evaluation Section, Drug assessment of annual needs has been Enforcement Administration, delegated to the Administrator of the DEPARTMENT OF JUSTICE Washington, DC 20537, Telephone: DEA by 28 CFR section 0.100. The (202) 307–7183. Drug Enforcement Administration Administrator, in turn, has redelegated SUPPLEMENTARY INFORMATION: Section this function to the Deputy [Docket No. DEA–306P] 713 of the Combat Methamphetamine Administrator, pursuant to 28 CFR Assessment of Annual Needs for the Epidemic Act of 2005 (Title VII of Pub. section 0.104. List I Chemicals Ephedrine, L. 109–177) (CMEA) amended section The proposed year 2008 assessment of Pseudoephedrine, and 306 of the Controlled Substances Act annual needs represents those quantities Phenylpropanolamine for 2008: (CSA) (21 U.S.C. section 826) by adding of ephedrine, pseudoephedrine, and Proposed ephedrine, pseudoephedrine, and phenylpropanolamine which may be phenylpropanolamine to existing manufactured domestically and/or AGENCY: Drug Enforcement language to read as follows: ‘‘The imported into the United States to Administration (DEA), Justice. Attorney General shall determine the provide adequate supplies of each ACTION: Notice of proposed annual total quantity and establish production chemical for: The estimated medical, assessment of needs for 2008. quotas for each basic class of controlled scientific, research, and industrial needs substance in schedules I and II and for of the United States; lawful export SUMMARY: This notice proposes the ephedrine, pseudoephedrine, and requirements; and the establishment initial year 2008 assessment of annual phenylpropanolamine to be and maintenance of reserve stocks. needs for certain List I chemicals in manufactured each calendar year to Pursuant to 21 CFR part 1315, the accordance with the Combat provide for the estimated medical, Deputy Administrator of the DEA will, Methamphetamine Epidemic Act of scientific, research, and industrial needs in early 2008, adjust the assessment of 2005 (CMEA), enacted on March 9, of the United States, for lawful export annual needs and individual importing 2006. The Act required DEA to establish requirements, and for the establishment and manufacturing quotas allocated for production quotas and import quotas for and maintenance of reserve stocks.’’ the year based upon 2007 year-end ephedrine, pseudoephedrine, and Further, section 715 of CMEA amended inventory and actual 2007 disposition phenylpropanolamine. This was done to 21 U.S.C. 952 ‘‘Importation of controlled data supplied by quota recipients for prevent the illicit use of these three substances’’ by adding the same List I ephedrine, pseudoephedrine, and chemicals in the clandestine chemicals to the existing language in phenylpropanolamine. manufacture of methamphetamine. The paragraph (a), and by adding a new The Deputy Administrator hereby enactment of the CMEA places paragraph (d) to read as follows: proposes that the year 2008 assessment

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of annual needs for the following List I mentioned chemicals without filing scientific, research and industrial needs chemicals, expressed in kilograms of comments or objections regarding the of the United States, for export anhydrous base or acid, be established others. If a person believes that one or requirements, and the establishment as follows: more of these issues warrant a hearing, and maintenance of reserve stocks. the individual should so state and Accordingly, the Deputy Administrator Proposed year summarize the reasons for this belief. has determined that this action does not 2008 assessment In the event that comments or List I chemicals of annual needs require a regulatory flexibility analysis. [kg] objections to this proposal raise one or This action meets the applicable more issues which the Deputy standards set forth in sections 3(a) and Ephedrine (for sale) ...... 11,500 Administrator finds warrant a hearing, 3(b)(2) of Executive Order 12988 Civil Ephedrine (for conver- the Deputy Administrator shall order a Justice Reform. sion) ...... 128,760 public hearing by notice in the Federal This action will not result in the Pseudoephedrine (for Register, summarizing the issues to be sale) ...... 511,100 expenditure by state, local, and tribal Phenylpropanolamine (for heard and setting the time for the governments, in the aggregate, or by the sale) ...... 5,545 hearing. private sector, of $120,000,000 or more Phenylpropanolamine (for The Office of Management and Budget (adjusted for inflation) in any one year, conversion) ...... 85,470 has determined that notices of quotas and will not significantly or uniquely are not subject to centralized review affect small governments. Therefore, no Ephedrine (for conversion) refers to under Executive Order 12866. actions were deemed necessary under the industrial use of ephedrine, i.e., that This action does not preempt or the provisions of the Unfunded which will be converted to modify any provision of state law; nor Mandates Reform Act of 1995. pseudoephedrine. does it impose enforcement This action is not a major rule as Phenylpropanolamine (for conversion) responsibilities on any state; nor does it defined by section 804 of the Small refers to the industrial use of diminish the power of any state to Business Regulatory Enforcement phenylpropanolamine, i.e., that which enforce its own laws. Accordingly, this Fairness Act of 1996 (Congressional will be converted to drug products action does not have federalism Review Act). This action will not result administered to patients with Acquired implications warranting the application in an annual effect on the economy of Immune Deficiency Syndrome and of Executive Order 13132. $100,000,000 or more; a major increase Attention Deficit Disorder. The ‘‘for The Deputy Administrator hereby in costs or prices; or significant adverse sale’’ assessments refer to the amount of certifies that this action will have no effects on competition, employment, ephedrine, pseudoephedrine, and significant impact upon small entities investment, productivity, innovation, or phenylpropanolamine intended for whose interests must be considered on the ability of United States-based ultimate use in products containing under the Regulatory Flexibility Act, 5 companies to compete with foreign- these List I chemicals. U.S.C. 601–612. The establishment of based companies in domestic and All interested persons are invited to the assessment of annual needs for the export markets. submit their comments in writing or List I chemicals ephedrine, electronically regarding this proposal pseudoephedrine, and Dated: September 13, 2007. following the procedures in the phenylpropanolamine is mandated by Michele M. Leonhart, ADDRESSES section of this document. A law. Deputy Administrator. person may object to or comment on the The assessments are necessary to [FR Doc. E7–18528 Filed 9–19–07; 8:45 am] proposal relating to any of the above- provide for the estimated medical, BILLING CODE 4410–09–P

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Reader Aids Federal Register Vol. 72, No. 182 Thursday, September 20, 2007

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING SEPTEMBER

Federal Register/Code of Federal Regulations At the end of each month, the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected by documents published since Laws 741–6000 the revision date of each title. 3 CFR 981...... 51990 Presidential Documents 987...... 51354 Executive orders and proclamations 741–6000 Proclamations: 1205...... 51159 The United States Government Manual 741–6000 7463 (See Notice of 1739...... 52779 September 12, Proposed Rules: Other Services 2007) ...... 52465 59...... 51378, 52956 Electronic and on-line services (voice) 741–6020 8170...... 51155 301...... 53171 Privacy Act Compilation 741–6064 8171...... 51157 305...... 53171 8172...... 51549 Public Laws Update Service (numbers, dates, etc.) 741–6043 983...... 51378 8173...... 51551 TTY for the deaf-and-hard-of-hearing 741–6086 993...... 51381 8174...... 51553 1779...... 52618 8175...... 53097 3575...... 52618 ELECTRONIC RESEARCH 8176...... 53099 4279...... 52618 Executive Orders: 4280...... 52618 World Wide Web 13444...... 52747 5001...... 52618 Full text of the daily Federal Register, CFR and other publications Administrative Orders: is located at: http://www.gpoaccess.gov/nara/index.html Memorandums: 8 CFR Memorandum of Federal Register information and research tools, including Public 103...... 53014 September 8, Inspection List, indexes, and links to GPO Access are located at: 212...... 53014 2007 ...... 52279 http://www.archives.gov/federallregister 214...... 53014 Notices: 248...... 53014 E-mail Notice of September 274a...... 53014 12, 2007 ...... 52465 299...... 53014 FEDREGTOC-L (Federal Register Table of Contents LISTSERV) is Presidential an open e-mail service that provides subscribers with a digital 1003...... 53673 Determinations: 1240...... 53673 form of the Federal Register Table of Contents. The digital form No. 2006-23 of of the Federal Register Table of Contents includes HTML and September 13, 2006 9 CFR PDF links to the full text of each document. (See No. 2007-32 of 93...... 53314 To join or leave, go to http://listserv.access.gpo.gov and select September 13, 94...... 53101, 53314 Online mailing list archives, FEDREGTOC-L, Join or leave the list 2007)...... 53409 95...... 53314 (or change settings); then follow the instructions. No. 2007-29 of August 96...... 53314 27, 2007 ...... 51351 PENS (Public Law Electronic Notification Service) is an e-mail No. 2007-30 of August service that notifies subscribers of recently enacted laws. 10 CFR 31, 2007 ...... 52749 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html No. 2007-31 of Proposed Rules: 490...... 52496 and select Join or leave the list (or change settings); then follow September 8, 1017...... 52506 the instructions. 2007 ...... 52751 FEDREGTOC-L and PENS are mailing lists only. We cannot No. 2007-32 of 12 CFR respond to specific inquiries. September 13, 2007 ...... 53409 585...... 50644 Reference questions. Send questions and comments about the Proposed Rules: Federal Register system to: [email protected] 4 CFR 327...... 53181 The Federal Register staff cannot interpret specific documents or 81...... 50643 652...... 52301 regulations. 5 CFR 14 CFR FEDERAL REGISTER PAGES AND DATE, SEPTEMBER 551...... 52753 23...... 51992 553...... 53411 33...... 50856, 50864 50643–50868...... 4 1600...... 53413 39 ...... 51161, 51164, 51167, 50869–51158...... 5 1605...... 53413 51697, 51994, 51996, 51997, 51159–51352...... 6 1630...... 51353 53102, 53104, 53106, 53108, 51353–51554...... 7 1631...... 53413 53110, 53112 1640...... 51353 43...... 53678 51555–51696...... 10 1651...... 53413 45...... 52467 51697–51974...... 11 1653...... 51353 71 ...... 51358, 51359, 51360, 51975–52280...... 12 1655...... 53413 51361, 51362, 51363 52281–52466...... 13 1690...... 53413 97 ...... 51169, 51171, 53680, 52467–52748...... 14 Proposed Rules: 53682 52749–53100...... 17 591...... 51200 135...... 53114 53101–53410...... 18 Proposed Rules: 53411–53672...... 19 7 CFR 23...... 53196 53673–53912...... 20 301...... 51975, 52281 33...... 51314 305...... 51975, 52776 39 ...... 50648, 51201, 51384, 770...... 51988 51386, 51388, 51719, 51722,

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51725, 52309, 52311, 52314, 522...... 51364, 51365 165 ...... 50877, 51555, 51557, 424...... 51012, 53628 52519, 53488, 53489, 53491, Proposed Rules: 51711, 52281 488...... 53628 53493, 53495, 53498, 53501, 2...... 53711 Proposed Rules: 489...... 53628 53699, 53701, 53704, 53706, 1301...... 53734 117...... 53202 Proposed Rules: 53709 165...... 52534 431...... 51397 71 ...... 51203, 51391, 53201 23 CFR 433...... 51397 36 CFR 153...... 53504 Proposed Rules: 440...... 51397 950...... 53736 Proposed Rules: 15 CFR 1193...... 53509 43 CFR 730...... 50869 24 CFR 1194...... 53509 3000...... 50882 732...... 50869 14...... 53876 1250...... 51744 3100...... 50882 734...... 50869 15...... 53876 3150...... 50882 37 CFR 736...... 50869 17...... 53876 3200...... 50882 738...... 50869, 52000 20...... 53876 1...... 51559 3500...... 50882 740...... 50869, 52000 3580...... 50882 24...... 53876 38 CFR 742...... 50869 25...... 53876 3600...... 50882 743...... 50869 26...... 53876 38...... 53430 3730...... 50882 744...... 50869 180...... 53876 39 CFR 3810...... 50882 745...... 50869, 52000 Proposed Rules: 3830...... 50882 746...... 50869 50...... 52206 Proposed Rules: 747...... 50869 51...... 52206 111...... 52025 44 CFR 748...... 50869 55...... 52206 3001...... 50744 64...... 52793 750...... 50869 58...... 52206 3010...... 50744 67...... 52796, 52820 752...... 50869 91...... 52206 3015...... 50744 Proposed Rules: 754...... 50869 3020...... 50744 67...... 51762, 52833 756...... 50869 25 CFR 40 CFR 758...... 50869 900...... 52790 45 CFR 6...... 53652 760...... 50869 98...... 50889 9...... 53118 762...... 50869 26 CFR 1626...... 52488 40...... 52008 764...... 50869 1 ...... 51703, 52003, 52470, 2551...... 51009 52 ...... 50879, 51564, 51567, 766...... 50869 53684 768...... 50869 51713, 52010, 52282, 52285, Proposed Rules: 46 CFR 770...... 50869 52286, 52289, 52472, 52791, 1 ...... 51009, 52319, 53742 401...... 53158 772...... 50869, 52000 53432, 53686 53...... 51009 774...... 50869, 52000 60...... 51365, 51494 Proposed Rules: 54...... 51009 10...... 52841 902...... 51699, 52668 72...... 51494 301...... 51009 15...... 52841 Proposed Rules: 75...... 51494 Ch. VII...... 50912 27 CFR 81...... 53432 47 CFR 806...... 52316 89...... 53118 24...... 51707 97...... 52289 73 ...... 52827, 53687, 53688 16 CFR 53...... 51710 180 ...... 51180, 52013, 53134, 90...... 51374 Proposed Rules: Proposed Rules: Proposed Rules: 53436, 53440, 53445, 53449, 4...... 51732, 53742 73 ...... 51208, 51575, 52337, 435...... 51728 53455 5...... 51732, 53742 247...... 52475 52338 17 CFR 7...... 51732, 53742 300...... 53151, 53463 24...... 53742 48 CFR 30...... 50645 721...... 53470 761...... 53152 Ch. 1...... 51187, 51310 Proposed Rules: 28 CFR 1039...... 53118 4...... 51306 210...... 53509 2...... 53114, 53116 Proposed Rules: 12...... 51306 228...... 53509 52...... 51306 229...... 53509 29 CFR 9...... 53204 49...... 51204 Ch. 2 ...... 51187 230...... 53509 2509...... 52004 202...... 51187 239...... 53509 51...... 52264 4022...... 52471 52 ...... 50650, 51574, 51747, 207...... 51188 240...... 53509 4044...... 52471 211...... 52293 249...... 53509 52027, 52028, 52031, 52038, Proposed Rules: 52264, 52319, 52320, 52325, 212...... 51189 18 CFR 215...... 52521 52828, 53743 216...... 51189 1910...... 51735 60...... 51392, 51394 227...... 51188 Proposed Rules: 2520...... 52527 62...... 50913, 52325 234...... 51189 1301...... 51572 2550...... 52021 63 ...... 50716, 52958, 52984, 236...... 51191 53814, 53838 237...... 51192, 51193 19 CFR 30 CFR 70...... 52264 245...... 52293 12...... 53414 Proposed Rules: 71...... 52264 252 ...... 51187, 51189, 51194, 103...... 52780 49...... 51338, 51320 72...... 51394 52293 178...... 52780 75...... 51320 75...... 51394 639...... 51568 181...... 52780 81...... 51747, 53743 652...... 51568 32 CFR Proposed Rules: 82...... 52332 727...... 53161 122...... 51730, 53394 199...... 53685 89...... 53204 742...... 53161 750...... 53417 97...... 52038, 52325 752...... 53161 20 CFR 751...... 53421 300...... 51758, 53509 Proposed Rules: 404...... 51173 756...... 53424 1039...... 53204 215...... 51209 405...... 51173 757...... 53427 252...... 51209 416...... 50871, 51173 41 CFR 33 CFR 300-80...... 51373 49 CFR 21 CFR 100...... 53118 209...... 51194 101...... 52783 117 ...... 50875, 51179, 52006, 42 CFR 213...... 51194 111...... 52790 52007, 53430 411...... 51012 214...... 51194

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215...... 51194 232...... 51194 1114...... 51375 20...... 53882 216...... 51194 233...... 51194 1115...... 51375 32...... 51534 217...... 51194 234...... 51194 Proposed Rules: 648...... 51699 218...... 51194 235...... 51194 171...... 53744 660...... 50906, 53165 219...... 51194 236...... 51194 173...... 53744 679 ...... 50788, 51570, 51716, 220...... 51194 238...... 51194 175...... 53744 51717, 51718, 52299, 52491, 221...... 51194 239...... 51194 229...... 50820, 52536 52492, 52493, 52494, 52668, 222...... 51194 240...... 51194 232...... 50820, 52536 53169 223...... 51194 241...... 51194 238...... 50820, 52536 224...... 51194 244...... 51194 1540...... 50916 Proposed Rules: 225...... 51194 571...... 50900, 51908 1544...... 50916 17 ...... 50918, 50929, 51766, 228...... 51194 585...... 51908 1560...... 50916 51770, 53211, 53749 229...... 51194 661...... 53688 216...... 52339 230...... 51194 1002...... 51375 50 CFR 648...... 53751 231...... 51194 1111...... 51375 17...... 51102, 52434 679...... 53516

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REMINDERS Swine, cattle, lamb, and Northeast Region Increment modeling The items in this list were boxed beef; reporting Standardized Bycatch procedures refinement; editorially compiled as an aid regulations Reporting Methodology prevention of significant to Federal Register users. reestablishment and Omnibus Amendment; deterioration new Inclusion or exclusion from revision; comments due implementation; source review; this list has no legal by 9-24-07; published 9-7- comments due by 9-24- comments due by 9-28- significance. 07 [FR 07-04405] 07; published 9-20-07 07; published 8-29-07 Onions grown in South Texas; [FR E7-18590] [FR E7-17104] comments due by 9-28-07; Air quality implementation RULES GOING INTO COMMERCE DEPARTMENT published 8-10-07 [FR E7- Patent and Trademark Office plans; approval and EFFECT SEPTEMBER 20, 15391] promulgation; various Practice and procedure: 2007 Oranges, grapefruit, States; air quality planning Ex parte patent appeals; tangerines, and tangelos purposes; designation of DEFENSE DEPARTMENT rules of practice before grown in Florida; comments areas: Board of Patent Appeals Civilian health and medical due by 9-28-07; published California; comments due by and Interferences; program of uniformed 7-30-07 [FR E7-14621] 9-26-07; published 8-27- services (CHAMPUS): comments due by 9-28- 07 [FR E7-16693] Prunes (dried) produced in 07; published 7-30-07 [FR TRICARE program— Air quality implementation California; comments due by E7-14645] Dental Program; National plans; approval and Defense Authorization 9-27-07; published 9-7-07 [FR 07-04369] CONSUMER PRODUCT promulgation; various Act changes; published SAFETY COMMISSION States: AGRICULTURE 9-20-07 Unstable refuse bins, ban; and DEPARTMENT California; comments due by ENVIRONMENTAL pacifier requirements; safety 9-27-07; published 8-28- PROTECTION AGENCY Agricultural Research standards; systematic 07 [FR E7-16822] Service Air quality implementation regulatory review; comments Air quality implementation plans; approval and Practice and procedure: due by 9-24-07; published plans; approval and promulgation; various Research, education, and 7-24-07 [FR E7-14248] promulgation; various States: economics mission area; ENERGY DEPARTMENT States; air quality planning Arizona; published 8-21-07 cooperative agreements; Energy Efficiency and purposes; designation of FEDERAL use, award, and Renewable Energy Office areas: COMMUNICATIONS administration; comments Energy conservation: Georgia; comments due by COMMISSION due by 9-24-07; published 9-28-07; published 8-29- Commercial and industrial Radio stations; table of 7-26-07 [FR E7-13550] 07 [FR E7-17133] assignments: equipment; energy COMMERCE DEPARTMENT Air quality implementation Various States; published 9- efficiency program— plans; approval and 20-07 International Trade Small electric motors; Administration promulgation; various INTERIOR DEPARTMENT public meeting; States: Tariff rate quotas: comments due by 9-28- Fish and Wildlife Service Texas; comments due by 9- Cotton shirting fabric; 07; published 8-10-07 Migratory bird hunting: 27-07; published 8-28-07 comments due by 9-24- [FR E7-15692] Late-season migratory bird [FR E7-16829] hunting regulation; 07; published 7-24-07 [FR ENVIRONMENTAL Pesticides; emergency published 9-20-07 E7-14321] PROTECTION AGENCY exemptions, etc.: TRANSPORTATION COMMERCE DEPARTMENT Air pollution; standards of Diflubenzuron; comments DEPARTMENT National Oceanic and performance for new due by 9-24-07; published Federal Aviation Atmospheric Administration stationary sources: 7-25-07 [FR E7-14161] Administration Fishery conservation and Source owners and Maintenance, preventive Pesticides; tolerances in food, management: operators; deadlines to animal feeds, and raw maintenance, rebuilding, and conduct performance alteration: Alaska; fisheries of agricultural commodities: Exclusive Economic tests; comments due by Recording of major repairs Chlorthalonil; comments due Zone— 9-26-07; published 8-27- by 9-25-07; published 7- and major alterations; 07 [FR E7-16840] published 9-20-07 Pollock; comments due by 27-07 [FR E7-14567] Air programs: Standard instrument approach 9-28-07; published 9-18- Glufosinate-ammonium; procedures; published 9-20- 07 [FR 07-04614] Consolidated Federal Air comments due by 9-24- 07 Shallow-water species; Rule; revisions— 07; published 7-25-07 [FR Standard instrument approach comments due by 9-26- Source owners and E7-14170] procedures; miscellaneous 07; published 9-14-07 operators; deadlines to Penoxsulam; comments due amendments; published 9- [FR 07-04562] conduct performance by 9-24-07; published 7- 20-07 Caribbean, Gulf, and South tests in force majeure 25-07 [FR E7-14335] TREASURY DEPARTMENT Atlantic fisheries— circumstances; Superfund program: Internal Revenue Service Gulf of Mexico shrimp comments due by 9-26- National oil and hazardous Income taxes: and reef fish; comments 07; published 8-27-07 substances contingency Corporate estimated tax; due by 9-24-07; [FR E7-16835] plan priorities list; correction; published 9-20- published 7-26-07 [FR Stratospheric ozone comments due by 9-26- 07 E7-14450] protection— 07; published 8-27-07 [FR Northeastern United States Methyl Bromide phaseout; E7-16685] COMMENTS DUE NEXT fisheries— critical use exemption; GENERAL SERVICES WEEK Northeast Region comments due by 9-26- ADMINISTRATION standardized bycatch 07; published 8-27-07 Acquisition regulations: AGRICULTURE reporting methodology [FR E7-16896] Civilian Board of Contract DEPARTMENT omnibus amendment; Air quality implementation Appeals; procedure rules; Agricultural Marketing comments due by 9-24- plans: comments due by 9-28- Service 07; published 7-26-07 Preparation, adoption, and 07; published 7-5-07 [FR Livestock mandatory reporting: [FR E7-14455] submittal— 07-03064]

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HEALTH AND HUMAN Chemical mixtures due by 9-25-07; published Foreign corporations; gross SERVICES DEPARTMENT containing List 1 7-27-07 [FR E7-14492] income exclusions; cross- Centers for Medicare & ephedrine and/or reference; hearing; Medicaid Services pseudoephedrine; North American Industry comments due by 9-24- Classification System; Medicaid: exemptions eliminated; 07; published 6-25-07 [FR comments due by 9-24- adoption; comments due E7-12037] Non-emergency medical by 9-28-07; published 8- transportation program; 07; published 7-25-07 [FR E7-14295] 29-07 [FR E7-17151] State option to establish; LIST OF PUBLIC LAWS comments due by 9-24- JUSTICE DEPARTMENT TRANSPORTATION 07; published 8-24-07 [FR Death sentences in Federal DEPARTMENT This is a continuing list of E7-16172] cases; implementation: public bills from the current State capital counsel Federal Aviation HOMELAND SECURITY session of Congress which systems; certification Administration DEPARTMENT have become Federal laws. It process; comments due Coast Guard Airworthiness directives: may be used in conjunction by 9-24-07; published 8-9- Ports and waterways safety; with ‘‘PLUS’’ (Public Laws 07 [FR E7-15254] regulated navigation areas, Boeing; comments due by Update Service) on 202–741– safety zones, security NUCLEAR REGULATORY 9-24-07; published 8-8-07 6043. This list is also zones, etc.: COMMISSION [FR E7-15426] available online at http:// Rulemaking petitions: Nawiliwili Harbor, Kauai, HI; Diamond Aircraft Industries www.archives.gov/federal- comments due by 9-26- Crandall, Raymond A.; GmbH; comments due by register/laws.html. 07; published 9-5-07 [FR comments due by 9-25- 9-26-07; published 8-27- The text of laws is not 07-04357] 07; published 7-12-07 [FR 07 [FR E7-16891] published in the Federal Regattas and marine parades: E7-13539] Epstein, Eric; Three Mile Hawker Beechcraft; Register but may be ordered Head of the Connecticut in ‘‘slip law’’ (individual Regatta; comments due Island Alert, Inc.; comments due by 9-24- comments due by 9-24- 07; published 8-9-07 [FR pamphlet) form from the by 9-24-07; published 8- Superintendent of Documents, 23-07 [FR E7-16627] 07; published 7-10-07 [FR E7-15424] E7-13316] U.S. Government Printing HOMELAND SECURITY McDonnell Douglas; Office, Washington, DC 20402 PERSONNEL MANAGEMENT DEPARTMENT comments due by 9-24- (phone, 202–512–1808). The OFFICE Privacy Act; implementation; 07; published 7-24-07 [FR text will also be made Veterans’ preference: comments due by 9-24-07; E7-14043] available on the Internet from published 8-23-07 [FR E7- Active duty; definition GPO Access at http:// 15966] change; comments due by Thrush Aircraft, Inc.; www.gpoaccess.gov/plaws/ 9-25-07; published 7-27- comments due by 9-24- index.html. Some laws may HOMELAND SECURITY 07 [FR E7-14490] 07; published 7-26-07 [FR DEPARTMENT not yet be available. POSTAL REGULATORY E7-14433] Transportation Security COMMISSION S. 1/P.L. 110–81 Turbomeca; comments due Administration Honest Leadership and Open Practice and procedure: by 9-27-07; published 8- Privacy Act; implementation; Government Act of 2007 Market dominant and 28-07 [FR E7-17003] comments due by 9-24-07; (Sept. 14, 2007; 121 Stat. published 8-23-07 [FR E7- competitive postal Class E airspace; comments 735) 15963] products; rate regulation; comments due by 9-24- due by 9-24-07; published Last List August 14, 2007 INTERIOR DEPARTMENT 07; published 9-4-07 [FR 8-9-07 [FR E7-15578] Fish and Wildlife Service 07-04269] TRANSPORTATION Endangered and threatened SECURITIES AND DEPARTMENT Public Laws Electronic species: EXCHANGE COMMISSION Notification Service Critical habitat International Financial National Highway Traffic (PENS) designations— Reporting Standards: Safety Administration Peirson’s milk-vetch; Financial statements comments due by 9-25- prepared without Consumer information: PENS is a free electronic mail 07; published 7-27-07 notification service of newly reconciliation to generally New Car Assessment [FR 07-03674] enacted public laws. To accepted accounting Program; safety labeling; subscribe, go to http:// Sierra Nevada bighorn principles; acceptance response to listserv.gsa.gov/archives/ sheep; comments due from foreign private reconsideration petitions; publaws-l.html by 9-24-07; published issuers; comments due by comments due by 9-27- 7-25-07 [FR 07-03591] 9-24-07; published 7-11- 07; published 8-13-07 [FR Note: This service is strictly 07 [FR E7-13163] JUSTICE DEPARTMENT E7-15743] for E-mail notification of new Drug Enforcement SMALL BUSINESS laws. The text of laws is not Administration ADMINISTRATION TREASURY DEPARTMENT available through this service. Records and reports of listed Small business size standards: Internal Revenue Service PENS cannot respond to chemicals and certain Calculation of the number of specific inquiries sent to this machines: employees; comments Income taxes: address.

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