Notices. Notice of proposed rulemaking
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BILLING CODE 4910-9X-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Parts 141 and 385 [Docket No. RM07-18-000] Elimination of FERC Form No. 423 November 2, 2007. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Notice of proposed rulemaking. SUMMARY: In this Notice of Proposed Rulemaking, the Federal Energy Regulatory Commission (Commission) is proposing to amend its regulations to eliminate the FERC Form No. 423, *Monthly Report of Cost and Quality of Fuels for Electric Plants* .
The Commission's infrequent use of the information no longer justifies the burden and cost of collecting it. Conversely, the Energy Information Administration has expressed a need for this information and, upon cessation of the Commission's collection, proposes to collect the information, as part of its newly proposed EIA-923. DATES: *Comment deadline:* Comments are due December 20, 2007. ADDRESSES: You may submit comments identified by Docket No. RM07-18-000, by one of the following methods: • *eFiling:* From the Commission's Web site: *http://www.ferc.gov* , follow the instructions for submitting comments electronically found by selecting eFiling under the Documents & Filing heading. • *Mail:* Commenters unable to file comments electronically must mail or hand deliver an original and 14 copies of their comments to the Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426.
Please refer to the Comment Procedures section for additional information. FOR FURTHER INFORMATION CONTACT: Lawrence Greenfield (Legal Information), Office of the General Counsel—Energy Markets, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, Telephone:
(202)502-6415, E-mail: *lawrence.greenfield@ferc.gov* . Patricia W. Morris (Technical Information), Division of Administration, Budget and Strategic Planning, Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, Telephone:
(202)502-8730, E-mail: *patricia.morris@ferc.gov* . James Krug (Technical Information), Division of Administration, Budget and Strategic Planning, Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, Telephone:
(202)502-8419, e-mail: *james.krug@ferc.gov* . SUPPLEMENTARY INFORMATION: 1. In this Notice of Proposed Rulemaking, the Commission is proposing to amend its regulations, 18 CFR 141.61, to eliminate its Form No. 423, Monthly Report of Cost and Quality of Fuels for Electric Plants (OMB No. 1902-0024). The Commission's infrequent use of the information no longer justifies the burden and cost of collecting it. While the Commission is proposing to eliminate the Form 423, the Energy Information Administration
(EIA)has expressed a need for this information and, upon cessation of the Commission's collection, has proposed to collect the information, as part of its newly proposed EIA-923 survey. 1 1 Energy Information Administration Electric Power Survey, OMB Control No. 1905-0129, Supporting Statement A, (submitted to the Office of Management and Budget for review on October 4, 2007), available at: *http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=200709-1905-003* . Background 2. Form 423 gathers information on the cost and quality of fuels delivered to steam electric generating plants of 50 MW or greater. This information has been used over the years for a variety of purposes, including:
(1)To conduct fuel reviews under Federal Power Act
(FPA)sections 205(a) and (e); 2
(2)to address fuel costs and fuel purchase practices affecting public utility rates under FPA sections 205 and 206; 3 and
(3)to detect abnormally high fuel costs in public utility fuel purchases indicative of affiliate preference under FPA sections 205 and 206. 4 2 16 U.S.C. 824d(a), (e). 3 16 U.S.C. 824d, 824e. 4 Id. 3. Form 423 is submitted electronically on a monthly basis by approximately 190 utilities for their 569 steam electric generating plants. Discussion 4. The issuance of Order No. 888 5 and the public utility industry's increasing reliance on market-based rates have created a diminished need for the Form 423 information; greater use of market-based rates has resulted in less reliance on cost-based rates and less need to evaluate rates by reference to the utility's costs. In short, there are fewer public utilities with cost-based rates 6 and particularly with fuel adjustment clauses as part of their rates. This, in turn, has resulted in fewer rate cases and fewer complaints filed with the Commission. Moreover, should the Commission have a need for information concerning fuel costs and purchases, it can obtain such information on a case-by-case basis through special reports, investigations, or in formal proceedings. 7 5 *Promoting Wholesale Competition Through Open Access Non-discriminatory Transmission Services by Public Utilities; Recovery of Stranded Costs by Public Utilities and Transmitting Utilities* , Order No. 888, 61 FR 21540 (May 10, 1996), FERC Stats. & Regs. ¶ 31,036 (1996), *order on reh'g* , Order No. 888-A, 62 FR 12274 (Mar. 14, 1997), FERC Stats. & Regs. ¶ 31,048 (1997), *order on reh'g* , Order No. 888-B, 81 FERC ¶ 61,248 (1997), *order on reh'g* , Order No. 888-C, 82 FERC ¶ 61,046 (1998), aff'd in *relevant part sub nom* . *Transmission Access Policy Study Group v. FERC* , 225 F.3d 667 (D.C. Cir. 2000), *aff'd sub nom* . *New York* v. *FERC* , 535 U.S. 1 (2002). 6 A review of data from the Electric Quarterly Reports for calendar year 2006 indicates that market-based power sales constituted ninety percent of jurisdictional power sales (reported as energy sales and booked out transactions). Five percent were at cost-based rates, and the other five percent could not be readily categorized given the information reported. 7 *See* , *e.g.* , 16 U.S.C. 825e, 825f. 5. The Commission's infrequent use of the information collected through Form 423, in sum, no longer justifies the burden of collecting it. The Commission therefore proposes to cease to collect the Form 423 information ending with the December 2007 information, due February 15, 2008. 6. In contrast to the Commission's lack of need for the information, the EIA, in a collection statement to the Office of Management and Budget (OMB), states that EIA has multiple uses for it and request approval to collect it. Presently, EIA collects similar information from nonutility generators and, as explained in EIA's collection statement to OMB, adding to it information from Commission-jurisdictional public utilities would, for the first time, capture all such data on one form for the entire industry. EIA further proposes to merge the combined data collection with information from three other existing EIA collections: EIA-906, EIA-920 and EIA-767, in an effort to improve data quality, consistency and reporting efficiency. The result, EIA states, will be a new survey, the EIA-923, Power Plant Operations Report. 7. The Commission proposes to collect Form 423 information ending with the December 2007 report, due February 15, 2008, to coordinate with the initiation of EIA's collection of that information. However, if EIA is not prepared to collect the information at that time, to prevent a gap in data continuity, the Commission will continue to collect the information, until such time as EIA is prepared to begin collection, but not beyond the December 2008 report, due in February 2009. 8. The annual estimated $385,128 cost to filers to provide the Form 423 information, added to the $193,869 cost to the Commission to collect it, means eliminating the collection would save $578,997. The added burden on EIA to collect the FERC Form 423 data, EIA states in its OMB submission, is offset by the added efficiencies of reorganizing their data collections. Solicitation of Comments 9. The Commission seeks comments both on its proposal to eliminate the Form 423, and on the date the Commission proposes to eliminate the Form 423. Information Collection Statement 10. OMB regulations require OMB to approve certain information collection requirements imposed by an agency. 8 Here, the Commission is proposing to cease collecting certain information. Nevertheless, OMB has been notified of the Commission's actions in this case. The Commission will submit a copy of the Notice of Proposed Rulemaking
(NOPR)to OMB for information purposes only. 8 5 CFR 1320.11. 11. Interested persons may obtain information on the elimination of these reporting requirements by contacting the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426 [Attn: Michael Miller, Information Services Division
(202)502-8415, fax:
(202)273-0873]. Comments also can be sent to the Office of Information and Regulatory Affairs of OMB [Attn: Desk Officer for the Federal Energy Regulatory Commission; phone,
(202)395-4650, fax:
(202)395-7285, e-mail: *oira_submission@omb.eop.gov.* Comments regarding EIA's collection of information now collected on Form 423 should be addressed to OMB at the above address. Environmental Analysis 12. Commission regulations require that an Environmental Assessment or an Environmental Impact Statement be prepared for any Commission action that may have a significant adverse effect on the human environment. 9 The Commission has categorically excluded certain actions from this requirement as not having a significant adverse effect on the human environment. No environmental consideration is necessary for the promulgation of a rule concerning information gathering, analysis or dissemination. 10 Because this NOPR concerns the elimination of an information collection, no environmental consideration is necessary. 9 *Regulations Implementing the National Environmental Policy Act* , Order No. 486, 52 FR 47897 (Dec. 17, 1987), FERC Stats. & Regs. ¶ 30,783
(1987)( *codified at* 18 CFR Part 380). 10 18 CFR 380.4(a)(5). Regulatory Flexibility Act Certification 13. The Regulatory Flexibility Act of 1980
(RFA)11 generally requires either a description and analysis of a rule that will have a significant economic impact on a substantial number of small entities or a certification that the rule will not have a significant economic impact on a substantial number of small entities. Most utilities to which this proposed rule applies would not fall within the RFA's definition of small entity. 12 Consequently, the Commission certifies that this NOPR, if adopted, will not have a significant economic impact on a substantial number of small entities. Moreover, elimination of the Form 423 will reduce the burden on all entities, including small entities. 11 5 U.S.C. 601-12. 12 5 U.S.C. 601(3), *citing* to section 3 of the Small Business Act, 15 U.S.C. 632. Section 3 of the Small Business Act defines a “small business concern” as a business that is independently owned and operated and that is not dominant in its field of operation. The Small Business Size Standards component of the North American Industry Classification System (NAICS) defines a small electric utility as one that, including its affiliates, is primarily engaged in the generation, transmission, and/or distribution of electric energy for sale and whose total electric output for the preceding fiscal year did not exceed four million MWh. 13 CFR 121.201. Comment Procedures 14. The Commission invites interested persons to submit comments on the changes proposed in this NOPR to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due December 20, 2007. Comments must refer to Docket No. RM07-18-000, and must include, in the comments, the commenter's name, the organization represented, if applicable, and the address. Comments may be filed either in electronic or paper format. 15. Comments may be filed electronically via the eFiling link found under the Documents & Filings heading on the Commission's Web site at *http://www.ferc.gov* . The Commission accepts most standard word processing formats, but requests commenters to submit comments in a text-searchable format rather than a scanned image format. Commenters filing electronically do not need to make a paper filing. Commenters that are not able to file comments electronically must send an original and 14 copies of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426. 16. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters. Document Availability 17. In addition to publishing the full text of this document in the **Federal Register** , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through the Commission's Home Page ( *http://www.ferc.gov* ) and in the Commission's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426. 18. From the Commission's Home Page on the Internet, the full text of this document is available in the Commission's document management system, eLibrary, in PDF and Microsoft Word format for viewing, printing, and downloading. To access this document in eLibrary, type the docket number (excluding the last three digits of the docket number), in the Docket Number field. 19. User assistance is available for eLibrary and the Commission's Web site during normal business hours. For assistance, please contact FERC Online Support at
(202)502-6652 (toll-free at 1-866-208-3676), e-mail *fercon-linesupport@ferc.gov* , or contact the Public Reference Room at
(202)502-8371, TTY
(202)502-8659, e-mail: *public.referenceroom@ferc.gov* . List of Subjects 18 CFR Part 141 Electric power, Reporting and recordkeeping requirements. 18 CFR Part 385 Administrative practice and procedure, Electric power, Penalties, Pipelines, Reporting and recordkeeping requirements By direction of the Commission. Kimberly D. Bose, Secretary. In consideration of the foregoing, the Commission proposes to amend parts 141 and 385, Chapter I, Title 18, *Code of Federal Regulations* , as follows: PART 141—STATEMENTS AND REPORTS (SCHEDULES) 1. The authority citation for part 141 continues to read as follows: Authority: 15 U.S.C. 79; 16 U.S.C. 791a-828c, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352. § 141.61 [Removed and reserved] 2. Section 141.61 is removed and reserved. PART 385—RULES OF PRACTICE AND PROCEDURE 3. The authority citation for part 385 continues to read as follows: Authority: 5 U.S.C. 551-557; 15 U.S.C. 717-717z, 3301-3432; 16 U.S.C.791a-825v, 2601-2645; 28 U.S.C. 2461; 31 U.S.C. 3701, 9701; 42 U.S.C. 7101-7352, 16441, 16451-16463; 49 U.S.C. 60502; 49 App. U.S.C. 1-85 (1988). § 385.2011 [Amended] 4. Section 385.2011, paragraph (a)(8) is removed and reserved. [FR Doc. E7-22550 Filed 11-19-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 [Docket No. DEA-296P] RIN 1117-AB10 Removal of Thresholds for the List I Chemicals Pseudoephedrine and Phenylpropanolamine AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. SUMMARY: The Drug Enforcement Administration
(DEA)is proposing to remove the thresholds for importation, exportation, and domestic distributions of the List I chemicals pseudoephedrine and phenylpropanolamine. This rulemaking is being conducted as part of DEA's implementation of the Combat Methamphetamine Epidemic Act of 2005 and is needed to implement the Act's requirements for import and production quotas and to address the potential diversion of these chemicals. DEA is also clarifying that all transactions of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, except retail transactions, are considered to be regulated transactions. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before January 22, 2008. ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-296” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be directly sent to DEA electronically by sending an electronic message to *dea.diversion.policy@usdoj.gov.* Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided on that site. An electronic copy of this document is also available at the *http://www.regulations.gov* web site. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here. *Posting of Public Comments:* Please note that all comments received are considered part of the public record and made available for public inspection online at *http://www.regulations.gov* and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the For Further Information paragraph. FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 at
(202)307-7297. SUPPLEMENTARY INFORMATION: DEA's Legal Authority DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act
(CSA)and Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1399. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, research, and industrial purposes and deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. The CSA, as amended, also requires DEA to regulate the manufacture, distribution, retail sale, import, and export of chemicals that may be used to manufacture controlled substances illegally. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Those classified as List II chemicals may be used to manufacture controlled substances. On March 9, 2006, the President signed the Combat Methamphetamine Epidemic Act of 2005 (CMEA), which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). Among other actions, CMEA imposed new requirements regarding the retail sale of scheduled listed chemical products (products containing ephedrine, pseudoephedrine, or phenylpropanolamine, that may be marketed or distributed lawfully in the United States under the Federal Food, Drug and Cosmetic Act as nonprescription products) (21 U.S.C. 802(45)(A)). In a separate rulemaking, “Retail Sales of Scheduled Listed Chemical Products; Self-Certification of Regulated Sellers of Scheduled Listed Chemical Products” [Docket No. DEA-291, RIN 1117-AB05] (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006), DEA promulgated regulations implementing these provisions. The CMEA also subjects material containing ephedrine, pseudoephedrine, and phenylpropanolamine to manufacturing and import restrictions. Specifically, CMEA amended section 1002 of the Controlled Substances Act (21 U.S.C. 952(a)(1)) by adding the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine to those narcotic raw materials whose importation into the United States is prohibited except for such amounts as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes. In a separate rulemaking, “Import and Production Quotas for Certain List I Chemicals” [Docket No. DEA-293, RIN 1117-AB08] (72 FR 37439, July 10, 2007), DEA promulgated regulations to implement these provisions. Further, the CMEA requires that importers of all listed chemicals provide DEA with information regarding the transferee, (i.e., the downstream customer) of the chemical, as well as information regarding the quantity of the chemical to be transferred. Importers are further required to provide DEA with a return declaration regarding each import after the transaction is completed (CMEA § 716, 21 U.S.C. 971(d) and (g), as amended). In a separate rulemaking, “Implementation of the Combat Methamphetamine Epidemic Act of 2005; Notice of Transfers Following Importation or Exportation” [Docket No. DEA-292, RIN 1117-AB06] (72 FR 17401, April 9, 2007; Temporary Stay of Certain Provisions 72 FR 28601, May 22, 2007), DEA promulgated regulations implementing these provisions. Further, the CMEA requires that the notice of importation (DEA Form 486) for ephedrine, pseudoephedrine, and phenylpropanolamine “shall include all information known to the importer on the chain of distribution of such chemical from the manufacturer to the importer.” (CMEA § 721, 21 U.S.C. 971(h) as amended). In a separate rulemaking, “Information of Foreign Chain of Distribution for Certain List I Chemicals” [Docket No. DEA-295, RIN 1117-AB07], DEA is promulgating regulations to implement this provision. Ephedrine, Pseudoephedrine, and Phenylpropanolamine The List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine all serve as precursor chemicals for the illicit manufacture of controlled substances. Ephedrine and pseudoephedrine are the primary precursors used in the synthesis of the controlled substances methamphetamine, a schedule II controlled substance, and methcathinone, a schedule I controlled substance. Phenylpropanolamine is the primary precursor used in the illicit synthesis of amphetamine, a schedule II controlled substance. Licit Use Ephedrine, pseudoephedrine, and phenylpropanolamine all have therapeutic uses in both over-the-counter and prescription drug products. Ephedrine is lawfully marketed under the Federal Food, Drug, and Cosmetic Act as an ingredient in nonprescription (“over-the-counter” (OTC)) drugs as a bronchodilator for the treatment of asthma. Ephedrine is also available OTC in combination with the active ingredient guaifenesin. As a prescription drug, ephedrine is used in parenteral (injectable) form in hospitals as part of an anesthesiology kit. Ephedrine has the beneficial effect of increasing blood pressure very rapidly in the event of hypotensive crisis (i.e., sudden loss of blood pressure sometimes experienced during surgery). Parenteral ephedrine is also sometimes used to relieve acute bronchospasm. Oral dosage forms of ephedrine are also available as prescription drugs for the treatment of asthma. These prescription drug products primarily consist of ephedrine in combination with other active ingredients such as potassium iodide (an expectorant) and/or theophylline (a bronchospamolytic). Pseudoephedrine is lawfully marketed under the Federal Food, Drug, and Cosmetic Act provisions for OTC use as a decongestant. Phenylpropanolamine has historically been marketed in the United States for OTC use as a decongestant and diet aid and there have been many legend (prescription) drug products that contain pseudoephedrine or phenylpropanolamine. In the vast majority of these preparations, pseudoephedrine or phenylpropanolamine were in combination with other active ingredients, such as antihistamines, expectorants, and/or antitussives. In November 2000, the U.S. Food and Drug Administration
(FDA)issued a public health advisory concerning phenylpropanolamine and requested that all drug companies discontinue marketing products containing phenylpropanolamine due to risk of hemorrhagic stroke. In response, many companies have voluntarily reformulated their products to exclude phenylpropanolamine. Subsequently, on December 22, 2005, the FDA published a Notice of Proposed Rulemaking (70 FR 75988) proposing to categorize all over-the-counter nasal decongestants and weight control drug products containing phenylpropanolamine preparations as Category II, nonmonograph, i.e., not generally recognized as being safe for human consumption. Most products containing phenylpropanolamine intended for humans have been withdrawn from the market, but phenylpropanolamine is still sold by prescription for veterinary uses. While ephedrine and pseudoephedrine are pharmacologically different (and have quite different therapeutic uses), they are directly substitutable in the production of methamphetamine. This is because of the similarity of the chemical structures of the two drugs. Discussion of This Rule In this rule, DEA is addressing two issues related to CMEA implementation. First, DEA is proposing to eliminate the thresholds for distribution, importation, and exportation of pseudoephedrine and phenylpropanolamine; the threshold for distribution, importation, and exportation of ephedrine was eliminated previously. Limits on retail transactions are set in the CMEA and were addressed in DEA's Interim Rule regarding the retail provisions of the CMEA (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006). Second, DEA is proposing to clarify that all distribution, importation, and exportation transactions involving drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine are regulated transactions. Thresholds Under the existing regulations (21 CFR 1310.04), the threshold for non-retail distribution, import, and export of pseudoephedrine is 1 kilogram and for phenylpropanolamine, 2.5 kilograms. A single transaction or multiple transactions in a month with a single customer that equal or exceed the threshold are considered regulated transactions and trigger the reporting and recordkeeping requirements of 21 CFR part 1310. DEA has not established a threshold for ephedrine; all non-retail distribution, import, and export transactions involving ephedrine are already subject to recordkeeping and reporting requirements. CMEA mandates that DEA establish the total annual need for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured or imported each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These requirements apply equally to products containing these three List I chemicals as they do to the List I chemicals themselves. To limit the supply of the chemicals to the amount needed to meet the national need, CMEA requires DEA to establish import and production quotas for all three chemicals. DEA published its proposed 2007 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine on October 19, 2006 (71 FR 61801). DEA published regulations implementing procedures for import and production quotas on July 10, 2007 (72 FR 37439). To obtain the information needed to assess the national need and set quotas to limit imports and production to meet that need, DEA identified two inadequacies regarding its existing regulations. First, persons who manufacture or import prescription drugs containing the chemicals are not registered. In another rulemaking, “Registration Requirements for List I Chemicals” [Docket No. DEA-294, RIN 1117-AB09], DEA is revising its registration requirements to cover manufacturers and importers of prescription drugs containing these chemicals and will issue quotas to them although the distribution and export of prescription drugs containing the chemicals will continue to be exempt from DEA regulatory control. The second inadequacy involves the thresholds that apply to pseudoephedrine and phenylpropanolamine. To determine the annual need and set quotas, DEA must obtain information on all imports and production involving the chemicals, not just those that exceed the existing thresholds. The existing thresholds, although relatively low, would allow a considerable market in the chemicals to continue unregulated. For example, under the current 1 kilogram (2.2 pound) threshold for pseudoephedrine, a person could import or distribute more than 2 pounds a month, or approximately 25 pounds a year, of pseudoephedrine without exceeding the threshold and triggering DEA's controls. Assuming a low 50 percent conversion rate of pseudoephedrine to methamphetamine, a person could annually manufacture approximately 12.5 pounds of methamphetamine with that total sum of sub-threshold quantities. DEA analysis for 2006 estimates that the national range in the street price for one pound of methamphetamine (powder) is between $2,500 and $48,000. To further implement the Combat Methamphetamine Epidemic Act of 2005, this rule seeks to curb the availability of pseudoephedrine at the wholesale level for illicit purposes. Additionally, under the current 2.5 kilogram (5.5 pound) threshold for phenylpropanolamine, a person could import or distribute more than 5 pounds a month, or approximately 66 pounds a year of phenylpropanolamine without exceeding the threshold and triggering DEA's controls. Assuming a low 50 percent conversion rate of phenylpropanolamine to amphetamine, a person could annually manufacture approximately 33 pounds of amphetamine with that total sum of sub-threshold quantities. The resulting amphetamine would have street value comparable to methamphetamine. To further implement the Combat Methamphetamine Epidemic Act of 2005, this rule seeks to curb the availability of phenylpropanolamine at the wholesale level for illicit purposes. Currently, DEA is notified of all imports and exports of these chemicals which exceed the established thresholds or for which no threshold is established. DEA does not, however, receive import and export notifications for imports and exports of listed chemicals less than established thresholds. If DEA does not eliminate the threshold for imports and exports of pseudoephedrine and phenylpropanolamine, DEA will not have complete and accurate information regarding the quantities of these chemicals imported into, and exported from, the United States. Further, manufacturers and distributors are not required to maintain records of distributions of listed chemicals at or below established thresholds. Without the maintenance of these records, DEA will not have complete and accurate information regarding the quantities of these chemicals being distributed domestically. To establish the controls that Congress mandated and limit imports and production to that needed for legitimate uses, DEA is proposing to eliminate the thresholds for all transactions involving the List I chemicals pseudoephedrine and phenylpropanolamine. As discussed previously, no threshold currently exists for transactions involving the List I chemical ephedrine; thus, all transactions are regulated. Any registrant manufacturing, distributing, importing, or exporting pseudoephedrine or phenylpropanolamine, in any quantity, either as bulk chemicals or in over-the-counter drug products, would be subject to the reporting and recordkeeping requirements. Any manufacturer or importer of prescription drug products containing one of the chemicals would also be subject to reporting and recordkeeping requirements. Importation of the chemicals is allowed only if it is within an import quota that the importer has applied for and been granted by DEA. The one exception to the import limits provided in CMEA is that an individual may import not more than 7.5 grams in any 30-day period of a scheduled listed chemical product (i.e., a product containing ephedrine, pseudoephedrine, or phenylpropanolamine which may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug) by means of the U.S. Postal Service or a private or commercial carrier (21 U.S.C. 844(a)). The distribution and export of prescription drug products containing the chemicals are not covered because DEA will be able to obtain the information it needs for the assessment of annual national needs from importers and manufacturers of these products. DEA has not determined that prescription drug products are being diverted. Regulated Transactions The definition of “regulated transaction” as amended by CMEA (21 U.S.C. 802(39)(A)(iv)) excludes:
(iv)Any transaction in a listed chemical that is contained in a drug that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), subject to clause (v), unless—
(I)The Attorney General has determined under section 204 of the Act (21 U.S.C. 814) that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and
(II)The quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General. Section 814
(b)states that: In removing a drug or group of drugs from exemption * * * the Attorney General shall consider, with respect to a drug or group of drugs that is proposed to be removed from exemption—
(1)The scope, duration, and significance of the diversion;
(2)Whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and
(3)Whether the listed chemical can be readily recovered from the drug or group of drugs. DEA in this rule is clarifying that nonprescription (“over-the-counter”) drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine do not qualify for the exemption from the definition of “regulated transaction” based on the three factors listed in 21 U.S.C. 814(b). Evaluation of Statutory Factors for Removal of Exemption From the Definition of “Regulated Transaction” Factor 1: Scope, Duration, and Significance of Diversion Throughout the late 1970s, methamphetamine was illicitly produced primarily through the use of the precursor phenylacetone ( phenyl-2-propanone (P2P)) by outlaw motorcycle gangs in the United States. In response to the use of P2P, DEA controlled P2P as a schedule II controlled substance in 1980, under the immediate precursor provisions of the CSA, specifically 21 U.S.C. 811(e). Clandestine laboratory operators responded by developing a variety of synthetic methods for producing P2P and also migrated to the use of ephedrine as precursor material. Trafficking groups widely used a procedure for converting ephedrine to methamphetamine that employed hydriodic acid and red phosphorus (HI/Red P). Use of the HI/Red P technique (also known as a “hydriodic acid reduction” or “ephedrine reduction”) exploded across the western and southwestern United States through the 1980s, and by 1990 accounted for 90 percent of all clandestine laboratory seizures reported to DEA. With the rapid increase in the use of the HI/Red P technique through the 1980s came increased law enforcement pressure. Purchases of bulk ephedrine were loosely monitored, and legitimate domestic suppliers of ephedrine began restricting or denying sales of bulk ephedrine to questionable buyers. In response, clandestine manufacturers turned to foreign suppliers, and thefts and diversion of bulk shipments of ephedrine also began to increase across the United States. In 1989, DEA control of chemicals was initiated with passage of the Chemical Diversion and Trafficking Act of 1988
(CDTA)(Subtitle A of Title VI of Pub. L. 100-690). This law placed recordkeeping and reporting requirements on a wide variety of precursors and essential chemicals used in every aspect of clandestine drug manufacture, including bulk powder ephedrine, pseudoephedrine, and phenylpropanolamine. In response to the regulations, traffickers moved to the illicit use of single-entity ephedrine OTC tablets as an unregulated source of precursor material for the production of methamphetamine. The extraction of the precursor chemical ephedrine from OTC tablets was an easy task. The tablets were simply ground using a kitchen blender and ephedrine extracted with an appropriate solvent. Upon filtration and evaporation of the solution, the traffickers were able to isolate the ephedrine bulk powder. Traffickers began widely exploiting what became known as the “tablet loophole.” Soon after, DEA began encountering “ephedrine extraction laboratories” whose primary purpose was to recover ephedrine from OTC tablets and capsules, either for resale on the black market or for use in associated clandestine methamphetamine laboratories. Many laboratories combined ephedrine extraction and methamphetamine production. Over the next three years, a number of well-publicized seizures of rogue businesses (and prosecutions of their owners) began to impact the tablet manufacturing industry, and the loophole allowing the sale of single-entity ephedrine products was closed in late 1993 with the passage of the Domestic Chemical Diversion Control Act of 1993 (DCDCA) (Pub. L. 103-200). In efforts to circumvent the provisions of the DCDCA, OTC tablet manufacturers began marketing new ephedrine combination products (i.e., ephedrine/guaifenesin tablets), which were exempt from DCDCA controls. The most dramatic shift forced by the CDTA and DCDCA, however, was a rapid transition from ephedrine to pseudoephedrine as the primary precursor for illicit methamphetamine manufacture. Although bulk pseudoephedrine was formally controlled under the CDTA in 1989, OTC products containing pseudoephedrine remained exempt under both the CDTA and DCDCA. In contrast to ephedrine, pseudoephedrine was present in a wide variety of pharmaceutical products, including hundreds of OTC cold and allergy preparations, and formal monitoring and control was considered (at that time) to be problematic. OTC pseudoephedrine-containing products, therefore, represented an easy precursor source for clandestine laboratory operators. By the mid-1990s, illicit methamphetamine laboratories using pseudoephedrine surpassed those still using ephedrine. In 1996, the existing controls on precursor and essential chemicals imposed by the CDTA and DCDCA were further tightened with the passage of the Comprehensive Methamphetamine Control Act of 1996
(MCA)(Pub. L. 104-237). What followed was a series of legislative actions on both the Federal and State levels to tighten controls on pharmaceutical products that serve as precursor material for clandestine methamphetamine laboratories. At the federal level, this effort included passage of the Methamphetamine Anti-Proliferation Act of 2000
(MAPA)(Title XXXVI of Pub. L. 106-310). Today, however, ephedrine and pseudoephedrine OTC products continue to serve as the primary precursor source for the illicit production of methamphetamine, which has spread across the entire United States in epidemic proportions. Current Seizures Methamphetamine remains the primary drug produced in illicit laboratories within the United States. Data from the El Paso Intelligence Center's
(EPIC)Clandestine Laboratory Database indicates that more than 10,010 methamphetamine laboratories were seized in calendar year 2004 and 5,883 laboratories in calendar year 2005 (as reported to EPIC through 05/08/07). According to EPIC, from January 2000 through December 2006, there were 7,087 laboratories reportedly using ephedrine and 46,290 reportedly using pseudoephedrine as precursor material for methamphetamine production. Additionally EPIC reports the seizure of 52 amphetamine laboratories (using phenylpropanolamine) during the same period. The vast majority of these laboratories used pharmaceutical products containing pseudoephedrine, ephedrine, and phenylpropanolamine as the source of precursor material. Illicit Uses *Factor 2: whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance.* *Factor 3: whether the listed chemical can be readily recovered from the drug or group of drugs.* The production of methamphetamine from ephedrine or pseudoephedrine can be accomplished via a series of reactions using widely available “recipes” and can be accomplished with little or no chemistry expertise. A variety of different methods exist to convert the precursor material to methamphetamine. If very small batches are made, there is not even a requirement to heat the reactants. For example, quantities of ephedrine or pseudoephedrine, iodine, and red phosphorous can be reacted with the addition of water and small quantities of methamphetamine can be produced. For larger batches the reactants are combined and heated for several hours. A variety of different reagents can be used to make the conversion to methamphetamine if the precursors ephedrine and pseudoephedrine are obtained. These reactants can also be used to convert phenylpropanolamine to amphetamine. Manufacturing procedures are readily available on the Internet and even unskilled persons can obtain a 50-70 percent yield of methamphetamine or amphetamine. Note: Pseudoephedrine and ephedrine can also serve as precursor material for the manufacture of the schedule I controlled substance methcathinone. From January 2000 through December 2006, there were 165 methcathinone laboratory seizures reported to EPIC. There is a common misconception in industry and among some in the public that OTC drug products, particularly pseudoephedrine or ephedrine products in combination with other medically active ingredients (combo products), are somehow less likely to be diverted or are less desirable among clandestine laboratory cooks for the manufacture of methamphetamine. This is not the case. Most of the clandestine laboratories found in the United States are using tablets, either single-entity or combination. In many of the methamphetamine exhibits analyzed by DEA analytical laboratories, the presence of antihistamines is detected, indicating that combination products were used in the reactions. While the vast majority of clandestine laboratories seized have used tableted pseudoephedrine and ephedrine products, gel caps and liquid dosage form products can easily serve as the source of precursor material for the production of methamphetamine. DEA scientific studies show that liquid, gel cap, and combination products are easily used as the source of precursor material and the pseudoephedrine/ephedrine from these products can be easily extracted with appropriate reagents/solvents. These reagents/solvents are all readily available at hardware and auto parts stores in the United States. The controlled substances produced from these chemicals, methamphetamine and amphetamine, have a high abuse potential. The public health consequences of the manufacture, trafficking, and abuse of these two substances are well known and documented. Findings Therefore, based on the above discussion, the Administrator of the Drug Enforcement Administration, pursuant to the authority delegated by the Attorney General, finds, pursuant to the criteria specified in 21 U.S.C. 814(b), that drug products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine are being diverted for the illicit production of controlled substances, namely methamphetamine and amphetamine. As DEA has discussed, these products have a demonstrated history over the past 20 years of diversion for illicit purposes. These List I chemicals are diverted regardless of formulation—liquid, nonliquid, gel capsule—and regardless of dosage strength. Accordingly, the Administrator of the Drug Enforcement Administration, pursuant to the authority delegated by the Attorney General, removes drug products containing the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine from exemption from the definition of “regulated transaction” under 21 U.S.C. 802(39)(a)(iv). As such, unless otherwise exempted, such materials would be subject to the chemical regulatory control provisions of the CSA. DEA is proposing to add a new section 1310.14 removing these drugs from the exemption. The CSA has specifically exempted retail transactions involving scheduled listed chemical products from the definition of regulated transaction (21 U.S.C. 802(39)(a)(v)) and established a separate set of regulations that control those retail transactions (71 FR 56008, September 26, 2006; corrected at 71 FR 60609, October 13, 2006). Technical Correction While drafting this rulemaking, DEA became aware of an inaccurate citation in 21 CFR 1310.10, the section paralleling the criteria to be considered in evaluating the statutory factors for removal of exemption from the definition of “regulated transaction” at 21 U.S.C. 814 and discussed above. Specifically, the definition of “regulated transaction” cited in 21 CFR 1310.10 is inaccurate. Therefore, to alleviate any confusion, DEA is proposing to correct this citation. Regulatory Certifications Regulatory Flexibility Act The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the provisions of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601-612). Without this rule, DEA will not be able to effectively implement the quota and import provisions of CMEA. As DEA has demonstrated throughout this document, traffickers and others in search of the chemicals necessary for clandestine manufacture of methamphetamine and amphetamine, are actively looking to exploit any loophole in chemical controls. As discussed above, the current thresholds create a loophole that could be exploited by traffickers who can turn below-existing-threshold quantities of List I chemicals into valuable, sought-after quantities of methamphetamine and/or amphetamine. The diversion of below-threshold quantities of these precursor chemicals could result in the illicit production of significant quantities of methamphetamine and/or amphetamine. CMEA was enacted to prevent this illicit production. Congress specifically imposed a 3.6 gram daily sales limit, and a 9 gram 30-day purchase limit for all transactions involving scheduled listed chemical products, as well as a 7.5 gram 30-day sales limit for sales of scheduled listed chemical products made by mobile retail vendors and mail order distributors. Congress, through the CMEA, also limited the quantity of scheduled listed chemical products an individual may import into the United States to not more than 7.5 grams during a 30-day period by means of shipping through any private or commercial carrier or the Postal Service. Congress further limited importation of ephedrine, pseudoephedrine, and phenylpropanolamine, prohibiting all imports except “such quantities * * * as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes,” (21 U.S.C. 952(a)(1)). It is inconsistent with Congressional intent to limit retail sales and purchases, and importation, of scheduled listed chemical products while allowing producers and traffickers to import or purchase from distributors quantities 100 times greater than retail sales limits without subjecting those transactions to any controls. As noted previously, below-threshold transactions are not documented to DEA; thus, DEA has no knowledge of the movement, including importation and exportation, of below-threshold quantities of pseudoephedrine and phenylpropanolamine. Specifically, non-retail distribution, import, and export transactions involving less than 1 kilogram of pseudoephedrine (approximately 2.2 pounds), or less than 2.5 kilograms of phenylpropanolamine (approximately 5.5 pounds), per month per customer would be exempt from DEA recordkeeping and reporting requirements. DEA cannot monitor, and does not receive reports on, these import, export, and distribution transactions. As discussed previously, the diversion of below-threshold quantities of these precursor chemicals could result in the illicit production of significant quantities of methamphetamine and/or amphetamine. Not removing the thresholds would also create a loophole in the system of import and production quotas established by the CMEA and implemented in an Interim Final Rule with Request for Comment (72 FR 37439, July 10, 2007). Without the reporting of all such transactions involving ephedrine, pseudoephedrine, and phenylpropanolamine to DEA, it would be more difficult for DEA to establish an assessment of annual national needs and to administer individual quotas for these List I chemicals. DEA would have incomplete information regarding these chemicals on which to base its assessments and quotas. Finally, this rule seeks to clarify that ephedrine, pseudoephedrine, and phenylpropanolamine have been, and continue to be, diverted for the illicit manufacture of controlled substances. By making this statement, this document hereby would formally include ephedrine, pseudoephedrine, and phenylpropanolamine, and drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, within the scope of the definition of “regulated transaction” found at 21 U.S.C. 802(39). This rule is necessary to avoid possible confusion in interpreting and applying the CMEA definition of “regulated transaction.” DEA notes that the effect of eliminating the thresholds will impose a minimal burden on regulated entities. Although it is likely that many of the registrants who handle the two chemicals are small businesses under the Small Business Administration definition of small entities, the changes impose virtually no burden on these entities for three reasons. First, most, if not all, legitimate transactions at the import, export, manufacturing, and distribution level are in excess of the previous thresholds. DEA does not expect any new registrations to result from the change. Second, although it is possible that some registrants may have some transactions that will be newly regulated, the recordkeeping for these can be met with standard business records. The only information required in records for regulated transactions is the name and address of the seller and purchaser (plus their DEA registration numbers, if applicable); the date of the transaction; the name, quantity, and form of packaging of the listed chemical; the method of transfer; and the method of identification used by the customer and any unique identification number associated with the identification. This information is normally included on purchase orders or invoices and the shipping papers and is needed to complete and track the transaction. As long as the purchaser can extract the records for examination, if necessary, no additional effort is needed. Because almost all business records for manufacturers, importers, and distributors are now generated and transmitted electronically, DEA does not expect that any registrant will need additional recordkeeping. Third, if any person is importing or exporting in very small quantities, there may be some additional import/export declarations required, but these forms require less than half an hour to complete and file. The only other requirement would be to report suspicious small transactions. These reports also require less than a half hour to complete and file. As noted above, DEA does not believe that legitimate importers or exporters are handling such small quantities. The purpose of this rule is to close a loophole that could be exploited by those seeking the chemicals for illicit purposes and to ensure that DEA can accurately assess the legitimate need. DEA, therefore, certifies that the rule will not have a significant economic impact on a substantial number of small entities. Executive Order 12866 The Deputy Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 section 1(b). It has been determined that this is “a significant regulatory action.” Therefore, this action has been reviewed by the Office of Management and Budget. This rule supports implementation of provisions of the CMEA. The CMEA is expansive in its breadth, essentially reclassifying ephedrine, pseudoephedrine, and phenylpropanolamine as scheduled listed chemicals, imposes new retail restrictions on these products, and mandates new domestic and import quotas. Without this rule, traffickers could exploit below-threshold transactions, which are not reported to DEA and for which records are not required to be maintained, to divert valuable quantities of pseudoephedrine and phenylpropanolamine for the clandestine manufacture of methamphetamine and/or amphetamine. Further, without this rule, DEA would not have complete information on which to base its assessment of the annual national needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine as DEA does not receive information regarding below-threshold transactions. This lack of information would create a loophole in the quota system, and would prevent DEA from fulfilling its legislative mandate that imports of pseudoephedrine and phenylpropanolamine be prohibited except for medical, scientific, or other legitimate purposes. Without this rule, DEA will not be able to effectively and fully implement the quota and import provisions of the CMEA. As discussed above, DEA does not anticipate that this change will impose more than the minimal costs that would be associated with reporting small transactions that the registrant thought suspicious and possibly filing forms for import and export notifications. The benefits of the rule are those associated with controlling access to chemicals used to manufacture methamphetamine, and other controlled substances, illicitly. As has been discussed extensively throughout this document, traffickers and others are actively looking to exploit any loophole in chemical controls to continue their operations. As noted previously, the current thresholds could permit a person to divert approximately 25 pounds of pseudoephedrine and 66 pounds of phenylpropanolamine annually, without exceeding existing thresholds. This rule closes a loophole that could result in the undocumented diversion of these chemicals for illicit production of significant quantities of methamphetamine and/or amphetamine. As noted previously in this rule, below-threshold transactions are not documented to DEA; the diversion of below-threshold quantities of these precursor chemicals could result in the illicit production of significant quantities of methamphetamine and/or amphetamine. Executive Order 12988 This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 This rulemaking does not impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. Paperwork Reduction Act This rule would require that records be maintained regarding distributions of the List I chemicals pseudoephedrine and phenylpropanolamine. These records are maintained as a normal course of business. The rule also proposes to reduce the thresholds for the List I chemicals pseudoephedrine and phenylpropanolamine from 1 kilogram and 2.5 kilograms, respectively, to zero, thereby requiring that DEA receive advance notification of all importations and exportations of these List I chemicals. DEA notes that it already receives some Import/Export Declarations if the cumulative amount of the transactions exceeds the thresholds on a monthly basis. Therefore, DEA does not believe that this change will significantly increase the burden associated with this information collection. Specifically, DEA estimates that 53 additional export notifications and 53 additional export return declarations will be received annually. Further, DEA estimates that 50 additional import declarations and 55 additional import return declarations will be received annually. DEA assumes 10 percent of all imports will not be transferred in the first 30 days and will necessitate submission of a subsequent return declaration. The receipt of these additional forms increases the hour burden by 34 hours annually. Therefore, DEA is revising its existing information collection [OMB approval number 1117-0023 “Import/Export Declaration for List I and List II Chemicals”, DEA Form 486] to reflect the increased burden associated with receipt of these import/export declarations. The Department of Justice, Drug Enforcement Administration, has submitted the following information collection request to the Office of Management and Budget for review and clearance in accordance with review procedures of the Paperwork Reduction Act of 1995. The proposed information collections are published to obtain comments from the public and affected agencies. All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the information collection instrument with instructions, should be directed to Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537. Written comments and suggestions from the public and affected agencies concerning the collection of information are encouraged. Your comments on the information collection-related aspects of this rule should address one or more of the following four points:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of Information Collection 1117-0023
(1)Type of Information Collection: Revision of a Currently Approved Collection.
(2)Title of the Form/Collection: Import/Export Declaration for List I and List II Chemicals.
(3)Agency form number, if any, and the applicable component of the Department sponsoring the collection: *Form number:* DEA Form 486. *Component:* Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.
(4)Affected public who will be asked or required to respond, as well as a brief *Abstract:* *Primary:* Business or other for-profit. *Other:* None. *Abstract:* Persons importing, exporting, and conducting international transactions with List I and List II chemicals must notify DEA of those transactions in advance of their occurrence, including information regarding the person(s) to whom the chemical will be transferred and the quantity to be transferred. Persons must also provide return declarations, confirming the date of the importation, exportation, or international transaction and transfer, and the amounts of the chemical transferred. This information is used to prevent shipments not intended for legitimate purposes.
(5)An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: A respondent may submit multiple responses. The below table presents information regarding the number of respondents, responses, and associated burden hours. Number of respondents Number of responses Average time per response Total (hours) Form 486 (export) 239 8,050 0.2 hour (12 minutes) 1,610 Form 486 (Export Return Declaration) 239 8,050 0.08 hour (5 minutes) 670.9 Form 486 (import) 230 2,450 0.25 hour (15 minutes) 612.5 Form 486 (import return declaration) * 230 2,695 0.08 hour (5 minutes) 224.6 Form 486 (international transaction) 9 111 0.2 hour (12 minutes) 22.2 Form 486 (international transaction return declaration) 9 111 0.08 hour (5 minutes) 9.25 Quarterly reports for imports of acetone, 2-butanone, and toluene 110 440 0.5 hour (30 minutes) 220 Total 239 3,369.45 * DEA assumes 10 percent of all imports will not be transferred in the first 30 days and will necessitate submission of a subsequent return declaration.
(6)An estimate of the total public burden (in hours) associated with the collection: 3,370 annual burden hours. If additional information is required contact: Lynn Bryant, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530. List of Subjects in 21 CFR Part 1310 Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements. For the reasons set forth above, 21 CFR part 1310 is proposed to be amended as follows: PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES [AMENDED] 1. The authority citation for part 1310 continues to read as follows: Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890. 2. Section 1310.04 is amended by revising paragraphs (f)(1)(i) table and (ii), (g)(1)(i) through (vii), and adding paragraphs (g)(1)(viii) and
(ix)to read as follows: § 1310.04 Maintenance of records.
(f)* * *
(1)* * *
(i)* * * Code Chemical Threshold by base weight 8522 N-Acetylanthranilic acid, its esters, and its salts 40 kilograms. 8530 Anthranilic acid, its esters, and its salts 30 kilograms. 8256 Benzaldehyde 4 kilograms. 8735 Benzyl cyanide 1 kilogram. 8675 Ergonovine and its salts 10 grams. 8676 Ergotamine and its salts 20 grams. 8678 Ethylamine and its salts 1 kilogram. 6695 Hydriodic acid 1.7 kilograms (or 1 liter by volume). 8704 Isosafrole 4 kilograms. 8520 Methylamine and its salts 1 kilogram. 8502 3, 4-Methylenedioxyphenyl-2-propanone 4 kilograms. 8115 N-Methylephedrine, its salts, optical isomers, and salts of optical isomers 1 kilogram. 8119 N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers 1 kilogram. 6724 Nitroethane 2.5 kilograms. 8317 Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers 2.5 kilograms. 8791 Phenylacetic acid, its esters, and its salts 1 kilogram. 2704 Piperidine and its salts 500 grams. 8750 Piperonal (also called heliotropine) 4 kilograms. 8328 Propionic anhydride 1 gram. 8323 Safrole 4 kilograms.
(ii)For List I chemicals that are contained in scheduled listed chemical products as defined in § 1300.02(b)(34)(i), the thresholds established in paragraph
(g)of this section apply only to non-retail distribution, import, and export. Sales of these products at retail are subject to the requirements of Part 1314 of this chapter.
(g)* * *
(1)* * *
(i)Ephedrine, its salts, optical isomers, and salts of optical isomers
(ii)Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone)
(iii)Hypophosphorous acid and its salts (including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite, and sodium hypophosphite)
(iv)Iodine
(v)N-phenethyl-4-piperidone
(vi)Pseudoephedrine, its salts, optical isomers, and salts of optical isomers
(vii)Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers
(viii)Red phosphorus
(ix)White phosphorus (Other names: Yellow Phosphorus) 3. Section 1310.10 is amended by revising paragraph
(a)introductory text to read as follows: § 1310.10 Removal of the exemption of drugs distributed under the Food, Drug and Cosmetic Act.
(a)The Administrator may remove from exemption under section 1300.02(b)(28)(i)(D) any drug or group of drugs that the Administrator finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance. In removing a drug or group of drugs from the exemption the Administrator shall consider: 4. Section 1310.14 is added to read as follows: § 1310.14 Removal of exemption from definition of regulated transaction. The Administrator finds that the following drugs or groups of drugs are being diverted to obtain a listed chemical for use in the illicit production of a controlled substance and removes the drugs or groups of drugs from exemption under § 1300.02(b)(28)(i)(D) of this chapter pursuant to the criteria listed in § 1310.10 of this part:
(a)Nonprescription drugs containing ephedrine, its salts, optical isomers, and salts of optical isomers.
(b)Nonprescription drugs containing pseudoephedrine, its salts, optical isomers, and salts of optical isomers.
(c)Nonprescription drugs containing phenylpropanolamine, its salts, optical isomers, and salts of optical isomers. Dated: November 7, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7-22560 Filed 11-19-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 4 and 9 [Notice No. 77; Re: Notice No. 36] RIN: 1513-AA92 Proposed Establishment of the Calistoga Viticultural Area (2003R-496P) AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Notice of proposed rulemaking. SUMMARY: On March 31, 2005, the Alcohol and Tobacco Tax and Trade Bureau published a notice of proposed rulemaking to establish the Calistoga viticultural area in Napa County, California. In light of comments regarding the potential adverse impact on established brand names that we received in response to that prior notice, we issue this new notice of proposed rulemaking to seek comments on our proposal to provide “grandfather” protection for certain brand names used on existing certificates of label approval, provided those labels also carry information that would dispel an impression that the wine meets the requirements for using the viticultural area name. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. DATES: We must receive written comments regarding this notice on or before December 20, 2007. ADDRESSES: You may send comments on this notice to one of the following addresses: • *http://www.regulations.gov* (Federal e-rulemaking portal; follow the instructions for submitting comments); or • Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412. See the Public Participation section of this notice for specific instructions and requirements for submitting comments, and for information on how to request a public hearing. You may view copies of this notice and any comments we receive about this proposal at *http://www.regulations.gov* under Docket No. 2007-0067. You also may view copies of the previous notice regarding this subject and the comments received in response to it under the same docket number. In addition, you may view this notice, the previous notice, all comments received in response to the two notices, as well as all related petitions, maps, and supporting materials, by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. To make an appointment, call 202-927-2400. FOR FURTHER INFORMATION CONTACT: Amy R. Greenberg, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Suite 200E, Washington, DC 20220; telephone 202-927-8210; or e-mail *Amy.Greenberg@ttb.gov.* SUPPLEMENTARY INFORMATION: Background on Viticultural Areas TTB Authority Section 105(e) of the Federal Alcohol Administration Act (the FAA Act, 27 U.S.C. 201 *et seq.* ) requires that alcohol beverage labels provide consumers with adequate information regarding product identity and prohibits the use of misleading information on those labels. The FAA Act also authorizes the Secretary of the Treasury to issue regulations to carry out its provisions. The Alcohol and Tobacco Tax and Trade Bureau
(TTB)administers these regulations. Part 4 of the TTB regulations (27 CFR part 4) allows the establishment of definitive viticultural areas and the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) contains the list of approved viticultural areas. Definition Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region distinguishable by geographical features, the boundaries of which have been recognized and defined in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to its geographic origin. The establishment of viticultural areas allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of a viticultural area is neither an approval nor an endorsement by TTB of the wine produced in that area. Requirements Section 4.25(e)(2) of the TTB regulations outlines the procedure for proposing an American viticultural area
(AVA)and provides that any interested party may petition TTB to establish a grape-growing region as a viticultural area. Section 9.3(b) of the TTB regulations specifies the requirements for an AVA petition. The petition to establish Calistoga as an AVA was filed in accordance with these procedures and requirements. Prior Notice of Proposed Rulemaking On March 31, 2005, TTB published in the **Federal Register** (70 FR 16451) as Notice No. 36 a notice of proposed rulemaking regarding the establishment of the Calistoga viticultural area. In that notice, we requested comments from all interested persons by May 31, 2005. TTB received two comments regarding Notice No. 36 before the close of the comment period. Both comments fully support the establishment of the Calistoga viticultural area. Subsequent Comments Received After the close of the public comment period, we received representations on behalf of two entities opposing the establishment of the Calistoga viticultural area as proposed. These entities are Calistoga Partners, L.P., d.b.a. Calistoga Cellars, and Chateau Calistoga LLC, which uses “Calistoga Estate” as its trade name. In a written submission to TTB, representatives of Calistoga Partners, L.P., expressed opposition to the establishment of the Calistoga viticultural area due to the impact the establishment of an area named “Calistoga” would have on the winery and its existing wine labels. In particular, Calistoga Partners noted that it has been using the “Calistoga Cellars” name on wine labels since 1998. TTB notes that under 27 CFR 4.25(e), a wine may be labeled with a viticultural area appellation if, among other things, at least 85 percent of the wine is derived from grapes grown within the viticultural area named. Calistoga Partners indicated that its wines would not meet the 85 percent requirement for its existing labels if the proposed viticultural area were established. Because the winery has been using the “Calistoga Cellars” brand name on its labels since 1998, it may not rely upon the “grandfather” provision in 27 CFR 4.39(i)(2), which applies only to brand names used on certificates of label approval issued prior to July 7, 1986. The letter also stated that the partnership has collectively invested millions of dollars and years of effort to build the trade name, trademark, and brand name “Calistoga Cellars.” Its representatives claim that to lose the use of the name or to be restricted in its use would materially impact the winery. As to the merits of a “Calistoga” viticultural area, Calistoga Partners argues that the term “Calistoga” is most often associated with the town of Calistoga, which is known as a tourist destination rather than a specific viticultural area. For these reasons, Calistoga Partners requested that TTB:
(1)Reopen the public comment period to allow it and others to provide additional comment on alternative solutions that would protect Calistoga brand names;
(2)exempt Calistoga Partners from any restrictive consequences resulting from the establishment of the Calistoga viticultural area through a “grandfathering” approach;
(3)delay approval of the AVA until an industry-wide solution is implemented to protect Calistoga Partners; or
(4)allow Calistoga Partners to continue to use its existing labels with a TTB-approved notice on the back label. As previously noted, TTB also received comments opposing the establishment of the “Calistoga” viticultural area on behalf of Chateau Calistoga LLC, citing the impact that establishment of the AVA would have on existing labels bearing the “Calistoga Estate” trade name. This entity stated that it has spent considerable money and time building the “Calistoga Estate” name. According to that entity, its wines are made under contract with a winery in Santa Rosa, California, and are produced with grapes from the Napa region, but not necessarily from the Calistoga region. This commenter also supported use of a “grandfathering” approach. Revised Regulatory Text Proposed After careful consideration of the evidence submitted in support of the petition and the comments received, TTB believes that there is a substantial basis for the establishment of the viticultural area. The petitioners submitted sufficient evidence of the viticultural distinctiveness of the Calistoga area, and no evidence was provided to contradict the petitioners' evidence. TTB also believes that “Calistoga” is the most appropriate name for the area. There is ample evidence clearly showing that “Calistoga” is the name by which the area is locally and regionally known and that the term “Calistoga” by itself has been associated historically with viticulture, specifically Napa Valley viticulture. Consistent with previous practice, we considered alternative names as a means to resolve conflicts between existing labels and the establishment of a “Calistoga” proposed viticultural area. Previously, for example, the “Oak Knoll District of Napa Valley” viticultural area (T.D. TTB-9, 69 FR 8562) and the “Diamond Mountain District” viticultural area (T.D. ATF-456, 66 FR 29698) were established after resolving such conflicts, resulting in AVA names that were modifications of those originally proposed by the petitioners. The petition to establish the “Oak Knoll District of Napa Valley” viticultural area originally proposed the name “Oak Knoll District”. The petition to establish the “Diamond Mountain District” viticultural area originally proposed the name “Diamond Mountain” for the viticultural area. In these and similar cases, TTB found that name evidence supported the use of the modified names, that the modified names were associated with the proposed viticultural area boundaries, and that their use reduced potential consumer confusion with long-standing existing labels. In the two cases cited here, Oak Knoll District of Napa Valley and Diamond Mountain District, the petitioners also agreed to the modifications of the viticultural area names. In the case at hand, the petitioners and commenters have not suggested any modification to the proposed name that would resolve conflicts between existing brand names and the establishment of a “Calistoga” viticultural area. Moreover, TTB did not find any potential name modifications to be acceptable substitutes for the proposed “Calistoga” viticultural area name. Because the term “Calistoga” alone is a specific, not generic, descriptive name that is clearly associated with Napa Valley viticulture, regardless of whether there may be adequate evidence to support a name modification such as “Calistoga District”, the term “Calistoga” alone has viticultural significance, and therefore any viticultural area name including the term “Calistoga” would be as problematic as the proposed name. TTB believes that the evidence submitted by the petitioners indicates that designation of the Calistoga viticultural area would be in conformity with applicable law and regulations. We do not find the request by Calistoga Partners that TTB delay the approval of the “Calistoga” viticultural area “until an industry-wide solution is implemented to protect Calistoga Cellars” to be an appropriate or responsive resolution. The Calistoga case and cases with similar factual bases involve a fundamental conflict between two otherwise valid and appropriate TTB administrative actions, the approval of labels by TTB through issuance of COLAs and the subsequent approval of a petitioned-for AVA. However, TTB also believes that Calistoga Partners has demonstrated a legitimate interest in not losing the ability to continue to use its long-held Calistoga Cellars brand name on its wines in the same way it has been using this name. We believe it is desirable to find a solution that will address the legitimate interests of both the Calistoga petitioners, who have an interest in gaining formal recognition of a viticulturally significant area and name, and vintners who have an interest in retaining the use of long-held brand names. We also believe, as a fundamental tenet of administrative practice, that it is preferable to avoid, whenever possible, a situation in which one otherwise proper administrative action (issuance of a certificate of label approval in this case) is restricted by a subsequent, valid administrative action (establishment of a viticultural area). And perhaps most importantly, where a conflict arises between a proposed AVA name and an established brand name, we do not believe that, in the context of the labeling provisions of the FAA Act, it is an appropriate government role to make choices between competing commercial interests, if such choices can be avoided. Accordingly, for the reasons stated above, we are proposing to add in part 9 a new section covering the Calistoga viticultural area. The new part 9 section text would differ from the section text proposed in Notice No. 36 by the addition of a paragraph
(d)to set forth a “grandfather” provision that allows continued use of brand names that contain the term “Calistoga” even though the wine may not meet the appellation of origin requirements of part 4 for the use of the “Calistoga” appellation of origin. Under this “grandfather” provision, a brand name containing the word “Calistoga” may only appear on wine that does not meet the appellation of origin requirements if:
(1)The appropriate TTB officer finds that the brand name has been in actual commercial use for a significant period of time under one or more existing certificates of label approval that were issued under part 4 of this chapter before March 31, 2005; and
(2)the wine is labeled with information that the appropriate TTB officer finds to be sufficient to dispel the impression that the use of “Calistoga” in the brand name conforms to the appellation of origin requirements of § 4.25. In no case would the grandfather provision apply to a label approved on or after March 31, 2005, the date that Notice No. 36 was published in the **Federal Register** originally proposing the establishment of the Calistoga viticultural area. The proposed rule is intended to limit the adverse effect on established brands, and at the same time dispel any misleading impression that might exist as to the origin of the grapes used in those wines. We note that this proposed paragraph
(d)text would not extend to the use of the name “Calistoga Estate” because that name was submitted to TTB for label approval after the notice of proposed rulemaking was made public through publication in the **Federal Register** . This proposal would not affect the application of the current “grandfather” provision in 27 CFR 4.39(i)(2) to any Calistoga brand name used in an existing certificate of label approval issued prior to July 7, 1986. In this document we have also included a proposed amendment to 27 CFR 4.39(i)(1) to conform that text to the paragraph
(d)“grandfather” provision in the proposed “Calistoga” AVA text in part 9. Impact on Current Wine Labels Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. If we establish this proposed viticultural area, its name, “Calistoga,” will be recognized under 27 CFR 4.39(i)(3) as a name of viticultural significance. The text of the proposed regulation clarifies this point. Consequently, wine bottlers using “Calistoga” in a brand name, including a trademark, or in another label reference as to the origin of the wine, would have to ensure that the product either is eligible to use the viticultural area's name as an appellation of origin or meets the requirements for application of the existing “grandfather” provision or the “grandfather” provision proposed for the Calistoga AVA. For a wine to be eligible to use as an appellation of origin a viticultural area name or other term specified as being viticulturally significant in part 9 of the TTB regulations, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name or other term, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible to use the viticultural area name or other term as an appellation of origin and that name or term appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the viticultural area name or other term appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing a viticultural area name that was used as a brand name on a label approved before July 7, 1986. In addition to the amendment of § 4.39(i)(1) contained in this document, see 27 CFR 4.39(i)(2) for details. Public Participation Comments Invited We specifically invite comments from interested members of the public on the proposed “grandfather” provision protecting certain brand names used on existing certificates of label approval that contain the proposed “Calistoga” viticultural area name, provided those labels also carry information that would dispel an impression that the wine meets the requirements for using the viticultural area name. In addition, we invite comment on the period of time of actual commercial use that would be deemed “significant” under the rule, and on alternatives to the proposed regulatory text. We also solicit comments on what type of dispelling information is sufficient to prevent consumers from being misled as to the origin of the grapes used to produce such wines and comments on the appropriate type size and location on the label for such information. Any other comments related to the approaches in this proposed rule are invited. Comments that provide the factual basis supporting the views or suggestions presented will be particularly helpful in developing a reasoned regulatory decision of this matter. However, comments consisting of mere allegations or opinions are counterproductive to the rulemaking process that is designed to build a factual evidentiary record for the final rule. Submitting Comments You may submit comments on this notice by one of the following two methods: • *Federal e-Rulemaking Portal:* To submit a comment on this notice using the online Federal e-rulemaking portal, visit *http://www.regulations.gov* and select “Alcohol and Tobacco Tax and Trade Bureau” from the agency drop-down menu and click “Submit.” In the resulting docket list, click the “Add Comments” icon for Docket No. 2007-0067 and complete the resulting comment form. You may attach supplemental files to your comment. More complete information on using Regulations.gov, including instructions for accessing open and closed dockets and for submitting comments, is available through the site's “User Tips” link. • *Mail:* You may send written comments to the Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412. Please submit your comments by the closing date shown above in this notice. Your comments must include this notice number and your name and mailing address. Your comments must be legible and written in language acceptable for public disclosure. We do not acknowledge receipt of comments, and we consider all comments as originals. If you are commenting on behalf of an association, business, or other entity, your comment must include the entity's name as well as your name and position title. If you comment via *http://www.regulations.gov* , please enter the entity's name in the “Organization” blank of the comment form. If you comment via mail, please submit your entity's comment on letterhead. You may also write to the Administrator before the comment closing date to ask for a public hearing. The Administrator reserves the right to determine whether to hold a public hearing. Confidentiality All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure. Public Disclosure You may view copies of this notice and any electronic or mailed comments we receive about this proposal on the Federal e-rulemaking portal at *http://www.regulations.gov* under Docket No. 2007-0067. You also may view copies of the previous notice regarding this subject and the comments received in response to it under the same docket number. To view a posted document or comment, go to *http://www.regulations.gov* and select “Alcohol and Tobacco Tax and Trade Bureau” from the agency drop-down menu and click “Submit.” In the resulting docket list, click the appropriate docket number, then click the “View” icon for any document or comment posted under that docket number. All submitted and posted comments will display the commenter's name, organization (if any), city, and State, and, in the case of mailed comments, all address information, including e-mail addresses. We may omit voluminous attachments or material that we consider unsuitable for posting. You may also view copies of this notice, the previous notice, and all electronic and mailed comments received in response to the two notices, as well as all related petitions, maps, and supporting materials, by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. You may also obtain copies at 20 cents per 8.5 x 11-inch page. Contact our information specialist at the above address or by telephone at 202-927-2400 to schedule an appointment or to request copies of comments or other materials. Regulatory Flexibility Act We certify that this proposed rule will not have a significant economic impact on a substantial number of small entities. This proposed rule imposes no new reporting or recordkeeping requirement. Any benefit derived from the use of a viticultural area name is the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required. Executive Order 12866 This proposed rule is not a significant regulatory action as defined by Executive Order 12866. Therefore, it requires no regulatory assessment. Drafting Information Amy R. Greenberg and Michael D. Hoover of the Regulations and Rulings Division drafted this document. List of Subjects *27 CFR Part 4* Advertising, Customs duties and inspection, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements, Trade practices, Wine. *27 CFR Part 9* Wine. The Regulatory Amendment For the reasons discussed in the preamble, we propose to amend 27 CFR, chapter I, parts 4 and 9, as follows: PART 4—LABELING AND ADVERTISING OF WINE 1. The authority citation for part 4 continues to read as follows: Authority: 27 U.S.C. 205, unless otherwise noted. 2. In § 4.39, paragraph (i)(1) is amended by adding the words “or in § 9.209(d) of this chapter” after “subparagraph (2)”. PART 9—AMERICAN VITICULTURAL AREAS 3. The authority citation for part 9 continues to read as follows: Authority: 27 U.S.C. 205. Subpart C—Approved American Viticultural Areas 4. Subpart C is amended by adding § 9.209 to read as follows: § 9.209 Calistoga.
(a)*Name.* The name of the viticultural area described in this section is “Calistoga”. For purposes of part 4 of this chapter, “Calistoga” is a term of viticultural significance, but its use in a brand name is also subject to paragraph
(d)of this section.
(b)*Approved maps.* The appropriate maps used to determine the boundary of the Calistoga viticultural area are four United States Geological Survey 1:24,000 scale topographic quadrangle maps. They are titled:
(1)Mark West Springs, Calif. (1993);
(2)Calistoga, CA (1997);
(3)St. Helena, Calif. (1960, revised 1993); and
(4)Detert Reservoir, CA (1997).
(c)*Boundary.* The Calistoga viticultural area is located in northwestern Napa County, California. The boundary beginning point is on the Mark West Springs map at the point where the Napa-Sonoma county line intersects Petrified Forest Road in section 3, T8N/R7W. From this point, the boundary:
(1)Continues northeasterly along Petrified Forest Road approximately 1.9 miles to the road's intersection with the 400-foot contour line near the north bank of Cyrus Creek approximately 1,000 feet southwest of the intersection of Petrified Forest Road and State Route 128 on the Calistoga map;
(2)Proceeds generally east-southeast (after crossing Cyrus Creek) along the 400-foot contour line to its intersection with Ritchey Creek in section 16, T8N/R6W;
(3)Follows Ritchey Creek northeast approximately 0.3 miles to its intersection with State Route 29 at the 347-foot benchmark;
(4)Proceeds east-southeast along State Route 29 approximately 0.3 miles to its intersection with a light-duty road labeled Bale Lane;
(5)Follows Bale Lane northeast approximately 0.7 miles to its intersection with the Silverado Trail;
(6)Proceeds northwest along the Silverado Trail approximately 1,500 feet to its intersection with an unmarked driveway on the north side of the Silverado Trail near the 275-foot benchmark;
(7)Continues northeasterly along the driveway for 300 feet to its intersection with another driveway, and then continues north-northeast in a straight line to the 400-foot contour line;
(8)Follows the 400-foot contour line easterly approximately 0.7 miles to its intersection with an unimproved dirt road (an extension of a road known locally as the North Fork of Crystal Springs Road), which lies in the Carne Humana Land Grant approximately 1,400 feet southwest of the northwest corner of section 11, T8N/R6W on the St. Helena map;
(9)Continues northerly along the unimproved dirt road approximately 2,700 feet to its intersection with the 880-foot contour line in section 2, T8N/R6W;
(10)Follows the meandering 880-foot contour line northwesterly, crossing onto the Calistoga map in section 2, T8N/R6W, and continues along the 880-foot contour line through section 3, T8N/R6W, sections 34 and 35, T9N/R6W, (with a brief return to the St. Helena map in section 35), to the 880-contour line's intersection with Biter Creek in the northeast quadrant of section 34, T9N/R6W;
(11)Continues westerly along the meandering 880-foot contour line around Dutch Henry Canyon in section 28, T9N/R6W, and Simmons Canyon in section 29, T9N/R6W, to the contour line's first intersection with the R7W/R6W range line in section 30, T9N/R6W;
(12)Continues northerly along the meandering 880-foot contour line across the two forks of Horns Creek and through Hoisting Works Canyon in section 19, T9N/R6W, crossing between the Calistoga and Detert Reservoir maps, to the contour line's intersection with Garnett Creek in section 13, T9N/R7W, on the Detert Reservoir map;
(13)Continues westerly along the meandering 880-foot contour line, crossing between the Calistoga and Detert Reservoir maps in sections 13 and 14, T9N/R7W, and in the region labeled “Mallacomes or Moristul y Plan de Agua Caliente,” to the contour line's intersection with the Napa-Sonoma county line approximately 1.1 miles northeast of State Route 128 in the “Mallacomes or Moristul y Plan de Agua Caliente” region, T9N/R7W, of the Mark Springs West map; and
(14)Proceeds southerly along the Napa-Sonoma county line to the beginning point.
(d)*Brand names.* A brand name containing the word “Calistoga” may be used on a label only if:
(1)The wine meets the appellation of origin requirements of § 4.25 of this chapter for the viticultural area established by this section;
(2)The appropriate TTB officer finds that the brand name has been in actual commercial use for a significant period of time under one or more existing certificates of label approval that were issued under part 4 of this chapter before March 31, 2005, and the wine is labeled with information that the appropriate TTB officer finds to be sufficient to dispel the impression that the use of “Calistoga” in the brand name conforms to the appellation of origin requirements of § 4.25 of this chapter; or
(3)The use of the brand name complies with § 4.39(i)(2) of this chapter. Signed: November 7, 2007. John J. Manfreda, *Administrator* . Approved: November 7, 2007. Timothy E. Skud, *Deputy Assistant Secretary (Tax, Trade, and Tariff Policy)* . [FR Doc. E7-22715 Filed 11-19-07; 8:45 am] BILLING CODE 4810-31-P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 4, 9, and 70 [Notice No. 78] RIN 1513-AB39 Proposed Revision of American Viticultural Area Regulations (2006R-325P) AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Notice of proposed rulemaking. SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau
(TTB)proposes to amend its regulations concerning the establishment of American viticultural areas (AVAs). The proposed changes address the effect that the approval of an AVA may have on established brand names. In addition, the proposed changes provide clearer regulatory standards for the establishment of AVAs within AVAs. The proposed amendments also clarify the rules for preparing, submitting, and processing viticultural area petitions. Finally, we propose to add to the regulations statements regarding the viticultural significance of established viticultural area names, or key portions of those names, for wine labeling purposes. DATES: We must receive written comments on or before January 22, 2008. ADDRESSES: You may send comments on this notice to one of the following addresses: • *E-mail: http://www.regulations.gov* (Federal e-rulemaking portal; follow the instructions for submitting comments); • *U.S. mail:* Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412; or • *Hand Delivery/Courier in lieu of mail:* Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW., Suite 200-E, Washington, DC 20005. See the Public Participation section of this notice for specific instructions and requirements for submitting comments, and for information on how to request a public hearing. You may view copies of this notice and any comments we receive about this proposal at *http://www.regulations.gov* under Docket No. 2007-0068. You also may view copies of this notice and any comments we receive about this proposal by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. To make an appointment, call 202-927-2400. FOR FURTHER INFORMATION CONTACT: Rita D. Butler, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW., Suite 200-E, Washington, DC 20220; telephone: 202-927-1608, fax: 202-927-8525. SUPPLEMENTARY INFORMATION: Background TTB Authority Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels, and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau
(TTB)administers the regulations promulgated under the FAA Act. Part 4 of the TTB regulations (27 CFR part 4) provides for the establishment of definitive viticultural areas and for the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) prescribes the standards for submitting a petition to establish a new American viticultural area
(AVA)and contains a list with descriptions of all approved AVAs. Part 70 of the TTB regulations (27 CFR part 70) includes provisions regarding rulemaking petition procedures. Definition Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region distinguishable by geographic features, the boundaries of which have been recognized and defined in part 9 of the TTB regulations. These AVA designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to its geographic origin. The establishment of viticultural areas allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of a viticultural area is neither an approval nor an endorsement by TTB of the wine produced in that area. Current AVA Petition Process Section 9.3 of the TTB regulations (27 CFR 9.3) sets forth the procedure and standards for the establishment of AVAs. Paragraph
(a)of that section states that TTB will use the rulemaking process based on petitions received in accordance with §§ 4.25(e)(2) and 70.701(c) to establish AVAs. Paragraph
(b)of § 9.3 states that a petition for the establishment of an AVA must contain the following: • Evidence that the name of the viticultural area is locally and/or nationally known as referring to the area specified in the application; • Historical or current evidence that the boundaries of the viticultural area are as specified in the application; • Evidence relating to the geographical features (climate, soil, elevation, physical features, etc.) that distinguish the viticultural features of the proposed area from surrounding areas; • The specific boundaries of the viticultural area, based on features that can be found on United States Geological Survey (U.S.G.S.) maps of the largest applicable scale; and • A copy of the appropriate U.S.G.S. map(s) with the boundaries prominently marked. The Need for Regulatory Changes For a number of reasons, TTB and Treasury believe that a comprehensive review of the AVA program is warranted in order to maintain the integrity of the program. First, we are concerned that because the establishment of an AVA can limit the use of existing brand names, approval of an AVA can have a deleterious effect on established businesses, can limit competition, and can be used by petitioners to adversely affect a competitor's business. We note in this regard that where a conflict exists between a proposed AVA name and an established brand name used on a wine label approved by TTB, a choice must be made between competing commercial interests; we do not believe that, in the context of the labeling provisions of the FAA Act, it is an appropriate governmental role to make choices that undermine the commercial interests of particular entities, if such choices can be avoided. In addition, we note that over the years there has been an increase in the number of petitions for the establishment of new AVAs within already existing AVAs. Because the idea behind the recognition of an AVA is that it is a unique area for viticultural purposes with reference to what is outside it, we believe that preserving the integrity of the AVA program mandates clarifying the standards for AVAs to foster greater scrutiny on the establishment of new AVAs within existing AVAs. Finally, there is a need to explain and clarify the AVA petition submission and review process and to clearly state the existing authority to deny, and the grounds for denying, an AVA rulemaking petition. AVA Name and Brand Name Conflict The designation of a new AVA can create a conflict with existing brand names. This conflict can arise because a brand name that includes an approved AVA name may not be used unless at least 85 percent of the wine is derived from grapes grown within the boundaries of the AVA. Moreover, TTB prohibits the use of misleading brand names (27 CFR 4.33), and also prohibits brand names that tend to create the impression that the wine is entitled to bear a designation recognized by TTB unless the wine meets the requirements for that designation (27 CFR 4.39(a)(8)). The establishment of a new AVA could give rise to a misleading impression regarding the provenance of a wine that carries a known brand name similar to the AVA name but that does not meet the 85 percent requirement that applies to AVA name usage, thereby not providing the consumer with adequate information as to the identity and quality of the wine and creating confusion for consumers and jeopardizing the producer's continued use of the wine label in question. The effect of the current regulatory provisions is to give precedence to the establishment of an AVA over the use of a brand name on a previously approved label. If a wine is not eligible for labeling with the viticultural area name and that name appears in the brand name, then the label would not be in compliance and TTB would require the bottler to obtain approval of a new label with a new brand name. In effect, vintners are on notice that continued use of a brand name having geographical significance could be jeopardized by the subsequent establishment of an AVA using an identical or similar name. In practice, however, TTB works with petitioners to amend petitions in order to limit the adverse impact on established brand names. For several reasons, we believe it is important to dispel any misconceptions that AVA petitions will be approved without regard to their impact on established brands. First, we do not wish to discount the commercial and informational value of an established brand name, which often is built up over a period of time by substantial investments in capital and hard work. Second, we do not wish to overlook the possibility that, contrary to the purpose of the FAA Act, the use of the new AVA name on a label could be misleading to those consumers who have associated that name with wine bearing an identical or similar brand name but produced from grapes grown outside the new AVA. Finally, we do not believe it to be sound public policy to allow an AVA petitioner to use a petition not for purposes consistent with the FAA Act but rather as a means to limit competition from holders of established brands. AVAs Within AVAs In recent years, TTB has received an increasing number of petitions that propose a boundary change to an existing AVA, the establishment of an AVA entirely or partially within an existing AVA, or the establishment of a new, larger AVA that would encompass all of one or more existing AVAs. TTB has come to recognize that such petitions can create the appearance of a conflict or inconsistency because, with reference to the criteria set forth in § 9.3(b), the new petition might draw into question the accuracy and validity of the evidence presented in support of the establishment of the existing AVA or the legitimacy of the justification for establishing the AVA. For example, with reference to the boundary description and the geographical features criteria, a change in an existing AVA boundary, or the adoption of a new AVA within an existing AVA, could suggest that the original boundary was improperly drawn or that there is no unity or consistency in the features of the existing AVA that give it a unique and distinctive identity in a viticultural sense. When a new AVA was established entirely within an existing AVA, TTB traditionally took the position that a wine that meets the 85 percent standard for the new, smaller AVA would automatically meet the 85 percent standard for the larger AVA. However, depending on the facts involved, we recognize that this position could run counter to the principle that an AVA is unique with reference to what is outside its boundary for viticultural purposes. In other words, depending on the unique facts presented in each AVA petition, an argument could be made that the smaller AVA is, by its very existence, distinct from the AVA that surrounds it, with the result that wine produced within it could not be labeled with the name of the larger AVA. We believe that in order to preserve the integrity of the AVA program, the above considerations demonstrate a need for greater clarity for, and closer scrutiny of, petitions for the establishment of new AVAs and for changes to existing AVAs. The petitioner should be expected to dispel any apparent inconsistency or to explain why it is acceptable. Petition Submission and Review Process Under TTB's current AVA petition process, we process all AVA petitions that are submitted to us. TTB's practice is to work with the petitioner both before and after submission of the petition to ensure that it contains all necessary information. TTB specialists spend considerable time reviewing the petition, contacting the petitioner, and requesting missing evidence from the petitioner. In some cases, deficient petitions are returned to the petitioner for revision and resubmission. Only after the petition is perfected (that is, it appears to contain all of the information required under § 9.3) do we proceed with preparation of an appropriate rulemaking document. As a general rule, the practice of TTB has been to accept the information provided by the petitioner in a perfected petition with the assumption that the information provided is true and correct. TTB does not conduct a detailed, separate investigation of the validity of the petition evidence at that point. TTB relies on comments provided in response to the published notice of proposed rulemaking (NPRM), to confirm or refute the information provided by the petitioner. We also note that whereas the TTB regulations in part 9 speak in terms of what an AVA petition must contain, they do not clearly reflect the fundamental administrative principle that the authority to grant carries a concomitant authority to deny an AVA petition. We have come to realize that some believe that all that is necessary to successfully petition for the establishment of an AVA is to submit a petition with evidence under the terms of § 9.3(b). Our view, however, is that under the current regulatory framework approval of an AVA petition is totally discretionary, because TTB already has authority not to initiate rulemaking, or not to approve the petitioned-for AVA action after publication of a proposal, for any one of a number of reasons, such as: • The evidence submitted with the petition does not adequately support use of the name proposed for a new AVA; • The evidence of distinguishing features submitted with the petition does not support drawing or redrawing the AVA boundary as proposed; • The extent of viticulture within the proposed boundary is not sufficient to constitute a grape-growing region within the intendment of the AVA program; or • Approval of a proposed new AVA would be inconsistent with the purpose of the FAA Act, contrary to another statute or regulation, or otherwise not in the public interest. We believe, however, that the part 9 regulations should more completely describe the submission and review process, including the various actions that TTB may take at each stage of the AVA petitioning procedure. Overview of Proposed Changes Based on the above considerations, TTB believes that the present regulations require further clarification of the regulatory basis for the most effective administration of the AVA program. To help clarify this situation, this document proposes to amend three provisions within part 4 of the TTB regulations that concern AVAs, to revise subparts A and B of part 9 of the TTB regulations, to amend various sections within subpart C of part 9, and to amend one provision within part 70 of the TTB regulations. Part 4 Amendments At the beginning of the AVA program, TTB's predecessor agency and Treasury issued 27 CFR 4.39(i), which permits the continued use of brand names that had been used in certificates of label approval (COLAs) issued before July 7, 1986, subject to application of any one of three conditions. The first two conditions refer to existing appellation of origin labeling requirements, and the third condition provides for labeling the wine with some other statement that TTB finds to be sufficient to dispel the impression that the geographic area suggested by the brand name is indicative of the origin of the wine. This “grandfather” approach was intended to protect brand names that had existed prior to the development of the AVA program. This solution, however, was not forward-looking and, therefore, does not address conflicts between AVAs and brand names in COLAs that came into existence after July 7, 1986. Since July 1986, more than 100 AVAs have been established in response to petitions from industry members and grape growers, reflecting the increased interest in, and spread of, viticulture throughout the United States. In addition, in recent years an increasing number of petitions have been submitted that, if the AVA were to be established with the petitioned-for name, would affect established brand names. As noted above, our intent in administering the AVA program, consistent with the intent behind the original “grandfather” approach, is to recognize established grape-growing regions while avoiding interference with established brand names. While TTB will continue to work with future AVA petitioners to limit the adverse impact on established brand names, we recognize that sometimes it will not be possible to amend a petition to achieve this result. In such cases, we believe that application of a new prospective “grandfather” approach would achieve the most balanced result. Accordingly, we are proposing to amend § 4.39(i) by adding a new “grandfathering” standard that would apply in the case of AVAs established after adoption of the final rule in this matter and that would be based on a specified number of years that a COLA was issued, and whether the brand label was in actual commercial use, before receipt by TTB of a perfected AVA petition. This approach would permit the establishment of the AVA and at the same time afford appropriate protection of existing labels. In addition, we propose to update two provisions within § 4.25(e) and conform them to the proposed changes to part 9, as explained below. Part 9 Amendments The proposed changes to subparts A and B of part 9 are intended to clarify the operation of the AVA petition and rulemaking process by explaining how a petitioner must submit an AVA petition to TTB, by setting forth with considerably greater specificity what information a petition must contain, and by explaining how TTB will process these petitions. The amended regulations would also clearly state that TTB may, at its discretion, decide not to proceed with rulemaking after receipt of a petition but that TTB will provide an explanation to the petitioner in such a case. Further, the proposed amendments to subparts A and B of part 9 specifically address the requirements for proposed boundary and name changes to existing AVAs, in order to ensure that an AVA proposal published by TTB to change an existing AVA (for example, a boundary expansion) has adequate supporting evidence. The specification of requirements for boundary changes will ensure that TTB receives petitions that conform to AVA regulatory standards rather than to considerations that are not central to the AVA concept, such as the desire to bring an individual vineyard into an existing AVA. We also propose to clarify in the subpart A and B regulatory texts that TTB has the discretion to decide whether or not to proceed with rulemaking with regard to any submitted and perfected AVA petition, provided the reasons are communicated to the petitioner in writing. In addition, the proposed amendments reflect the authority of TTB to decide not to proceed with approval of the petitioned-for AVA action after publication of the NPRM. To these ends, the proposed regulatory amendments attempt to make a clear distinction between the petition process and the rulemaking process, because a decision not to go forward may be made at either stage. The proposed amendments in subpart C are intended to draw the attention of the reader to the viticultural significance of names of previously established AVAs, or notable portions of those names, for wine labeling purposes under part 4 of the TTB regulations. These amendments are consistent with the practice employed by TTB over the past several years of including a second sentence in paragraph
(a)of each section covering a new AVA, to specify what is viticulturally significant as a result of the establishment of the AVA. While in most cases only the full name of the AVA is specified in each of the subpart C amendments contained in this document, in some instances a portion of the name is also identified as viticulturally significant if, based on TTB's label approval practice, its use on a label could be taken to represent the full AVA name. While we have attempted to avoid specifying a part of an AVA name where such action might jeopardize the continued use of an approved label, we specifically invite comments on whether any existing labels would be at risk if the proposed amendments are adopted as a final rule. Part 70 Amendment Finally, we propose a conforming amendment to § 70.701(c) of the TTB regulations (27 CFR 70.701(c)), which concerns petitions to change TTB's rules. Additional points regarding the proposed regulatory amendments are set forth in the section-by-section discussion below. Section-by-Section Discussion of Proposed Changes Section 4.25 We are proposing to revise the definition of viticultural area for American wine contained in § 4.25(e)(1)(i) to conform it to the new definition of “American viticultural area” proposed for part 9. In addition, we are proposing to revise § 4.25(e)(2) to conform it to the restructuring of part 9 and to correct a wording error in the present text. Section 4.39(i) We are proposing to add a new paragraph
(3)to § 4.39(i) to set forth the new grandfather provision, with a consequential redesignation of present paragraph
(3)as (4). The new provision would apply to AVAs and terms used in AVA names established as viticulturally significant under part 9 after the effective date of the final rule on this rulemaking action. As in the case of the present paragraph
(2)grandfather provision, the new text would require the use of dispelling information regarding the origin of the wine. The proposed new regulatory text refers to brand names that were used in COLAs issued prior to the 5-year period immediately preceding receipt of the perfected petition for establishment of the new AVA and that were in actual commercial use on labels for at least 3 years during that 5-year period as demonstrated by the COLA holder. We decided to propose two different periods of time because COLA issuance often precedes entry of a product into the marketplace by a year or more. We chose the 5-year period for COLA issuance because we believe that this is a reasonable period of time for the establishment of an ongoing viticultural enterprise, and we chose the 3-year period for actual commercial use because we believe that this is a reasonable period of time for achieving consumer recognition and loyalty. Under the proposed regulatory text, the mere possession of a COLA for 5 years or more would not be sufficient to trigger the new “grandfather” clause—it also would have to be established that the product in fact had a presence in the marketplace for at least 3 years during the 5-year period. We would not consider the mere placement of a label on a wine bottle to be actual commercial use because more would be required, that is, actual entry into the marketplace. In addition to new paragraph (3), we are proposing to amend § 4.39(i) by revising paragraphs
(1)and
(2)to better express the cross-references and to simplify the text of paragraph
(2)by removing paragraph (2)(i), which repeats a rule stated in paragraph
(1)and thus is redundant. These proposed changes are purely editorial and do not affect the substance of the texts. Section 9.0 We are proposing to add a new § 9.0 before subpart A to define the scope of the part 9 regulations. This new section replaces, and slightly expands upon the wording of, present § 9.1. We believe that this scope section is more appropriately placed before subpart A since it is intended to operate more as a reader's aid than as a substantive regulation. Section 9.1 This proposed definitions section would replace present § 9.11 and would be the first section under subpart A. We believe that it is better regulatory practice to have a definitions section as the first substantive section within a part rather than following other sections that use the terms defined in it. The text is divided into paragraphs
(a)and (b), with paragraph
(a)containing the various definitions and paragraph
(b)containing the “use of other terms” recitation in the present text, which is more substantive than definitional in nature. Within paragraph
(a)of new § 9.1, we propose to add new definitions covering “appropriate TTB officer,” “AVA,” “perfected petition,” “person,” “petition,” “petitioner,” “term of viticultural significance,” and “TTB.” In addition, we propose to combine the present definitions for “American” and “viticultural area” into one definition of “American viticultural area.” Finally, we propose a nonsubstantive wording change to the definition of “approved map.” Section 9.3 We are proposing to add a new § 9.3 to describe the delegations of the Administrator's authorities for the administration of part 9. This is consistent with the practice under other parts of the TTB regulations. Section 9.11 This new section would be the first section under subpart B, is intended to cover in more detail the petition submission process, and essentially reflects current practice as described above. It also clarifies both TTB's authority to decide whether to take action in response to a petition and the fact that mere receipt of a petition does not compel the publication of a rulemaking document in the **Federal Register** . Section 9.12 This new section sets forth significantly elaborated AVA petition content standards to address a number of the concerns outlined earlier in this document. The proposed text distinguishes between petitions for the establishment of a new AVA and petitions for changes to an existing AVA. It also sets forth specific additional standards for petitions proposing the establishment of a new AVA entirely within, or overlapping, an existing AVA, or proposing the establishment of a new, larger AVA encompassing all of one or more existing AVAs. In the case of an AVA entirely within another AVA, the text states that in some cases TTB may determine that the smaller AVA will not be considered to be part of the larger AVA because of its particular distinctiveness; such a determination would be made only in connection with rulemaking involving a new AVA and therefore would only be applied prospectively. In addition, in the case of changes to existing AVAs, the text distinguishes between boundary changes and name changes. TTB believes that these distinctions are necessary to maintain the integrity of the AVA program, because different evidence or other information may be necessary to support a petition depending on the specific petitioned-for action. Section 9.13 This new section covers the initial processing of an AVA petition after receipt by TTB, and it largely reflects TTB's present practice. The proposed text clarifies that the mere receipt of a perfected petition does not necessarily mean that TTB will proceed with rulemaking, and that the reasons for not proceeding with rulemaking will be set forth in writing to the petitioner. Thus, it is the intent of TTB to maintain a clear distinction between the processing of a petition and the initiation of rulemaking, which is the subject of the next section. If TTB decides to proceed with rulemaking, the new section also provides that TTB will advise the petitioner of the date of receipt of the perfected petition and will place a notice on the TTB Web site that the petition has been accepted for rulemaking. Section 9.14 This new section covers the rulemaking process, which commences only after a decision is made under § 9.13 to proceed to rulemaking (preparation and publication of the NPRM). It includes a description of various final actions that TTB might take after the close of the public comment period and review of the comments submitted and any other relevant information that comes to the attention of TTB that might have a bearing on the action taken by TTB. Among the proposed final actions that TTB might take is publication of a notice withdrawing the proposal to establish the AVA. In addition to a failure of a petition to identify an actual grape-growing region or to provide adequate name, boundary, and distinguishing features evidence, a proposed basis for such a withdrawal could be that adoption of the proposal would be inconsistent with a purpose of the FAA Act or any other Federal statute or regulation or would be otherwise contrary to the public interest. TTB believes that the latter grounds for withdrawing a proposal are appropriate based on the principle that administrative practice should always be consistent with, and never contrary to, law and public policy. As in the case of a withdrawal based on insufficient petition evidence, the **Federal Register** document announcing the withdrawal would explain the specific considerations upon which the withdrawal is based. Subpart C The proposed amendments within subpart C (in paragraphs 6 through 166) are consistent with the practice employed by TTB, which is to include a sentence in paragraph
(a)to specify what is viticulturally significant as a result of the establishment of the AVA. The specification of a portion of an AVA name is based on TTB's label approvals as reflected in the TTB Public COLA Registry. Section 70.701(c) The amendment to § 70.701(c) involves the addition of a reference to part 9 regarding a petition to establish a grape-growing region as a new AVA or to modify an existing AVA. Public Participation Comments Invited We invite comments from interested members of the public on this proposed rulemaking, including the proposed regulatory text. In addition, we invite comment on the following specific questions: 1. Whether additional or different standards should apply to the establishment of an AVA; for example, whether there should be a requirement that a specified percentage of the land mass of the proposed AVA be involved in viticultural activities. 2. Whether in some or all cases the establishment of a smaller AVA located within the boundaries of a larger AVA should result in a prohibition against the use of the larger AVA name on wine labels. 3. Whether the use of a “grandfather” provision to avoid conflicts between an established brand name and the establishment of a proposed AVA is appropriate. 4. Whether the terms of the proposed “grandfather” provision are appropriate and, if so, what time periods should apply to establish commercial use of the brand name involved in a conflict. 5. Whether it would be more appropriate to adopt an alternative to the “grandfather” provision proposed that would apply to brand names that have longstanding commercial use under one or more existing certificates of label approval without specifying a time period. 6. What type of dispelling information would prevent consumers from being misled as to the origin of the wine when a “grandfather” provision applies. Other comments for a requirement on dispelling information are encouraged. Submitting Comments You may submit comments on this notice by one of the following methods: • *Federal e-Rulemaking Portal:* To submit a comment on this notice using the online Federal e-rulemaking portal, visit *http://www.regulations.gov* and select “Alcohol and Tobacco Tax and Trade Bureau” from the agency drop-down menu and click “Submit.” In the resulting docket list, click the “Add Comments” icon for Docket No. 2007-0068 and complete the resulting comment form. You may attach supplemental files to your comment. More complete information on using Regulations.gov, including instructions for accessing open and closed dockets and for submitting comments, is available through the site's “User Tips” link. • *Mail:* You may send written comments to the Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412. • *Hand Delivery/Courier in lieu of mail:* Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW., Suite 200-E, Washington, DC 20005. Please submit your comments by the closing date shown above in this notice. Your comments must include this notice number and your name and mailing address. Your comments must be legible and written in language acceptable for public disclosure. We do not acknowledge receipt of comments, and we consider all comments as originals. If you are commenting on behalf of an association, business, or other entity, your comment must include the entity's name as well as your name and position title. If you comment via *http://www.regulations.gov,* please enter the entity's name in the “Organization” blank of the comment form. If you comment via mail, please submit your entity's comment on letterhead. You may also write to the Administrator before the comment closing date to ask for a public hearing. The Administrator reserves the right to determine whether to hold a public hearing. Confidentiality All submitted comments and attachments are part of the public record and subject to disclosure. Do not enclose any material in your comments that you consider to be confidential or inappropriate for public disclosure. Public Disclosure On the Federal e-rulemaking portal, we will post, and you may view, copies of this notice and any electronic, mailed, or hand-delivered comments we receive about this proposal. To view a posted document or comment, go to *http://www.regulations.gov* and select “Alcohol and Tobacco Tax and Trade Bureau” from the agency drop-down menu and click “Submit.” In the resulting docket list, click the appropriate docket number, then click the “View” icon for any document or comment posted under that docket number. All submitted and posted comments will display the commenter's name, organization (if any), city, and State, and, in the case of mailed or hand-delivered comments, all address information, including e-mail addresses. We may omit voluminous attachments or material that we consider unsuitable for posting. You also may view copies of this notice and any electronic, mailed, or hand-delivered comments we receive about this proposal by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. You may also obtain copies at 20 cents per 8.5 × 11-inch page. Contact our information specialist at the above address or by telephone at 202-927-2400 to schedule an appointment or to request copies of comments or other materials. Regulatory Analysis and Notices Executive Order 12866 This proposed rule is not a significant regulatory action as defined by Executive Order 12866. This proposed rule merely clarifies existing regulatory standards and imposes no new reporting, recordkeeping, or other administrative requirements. Therefore, it requires no regulatory assessment. Regulatory Flexibility Act We certify that these proposed regulations, if adopted, would not have a significant economic impact on a substantial number of small entities. As the submittal of a petition to TTB to establish a new AVA or change an existing AVA is voluntary, we believe that the proposed regulation imposes no new reporting, recordkeeping, or other administrative requirement. Therefore, no regulatory flexibility analysis is required. Paperwork Reduction Act The collection of information contained in this notice of proposed rulemaking has been submitted to the Office of Management and Budget
(OMB)for review in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)). Comments on the collection of information should be sent to OMB at *Alexander_T._Hunt@omb.eop.gov,* or by paper mail to Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503. A copy should also be sent to the Alcohol and Tobacco Tax and Trade Bureau by any of the methods previously described. Because OMB must complete its review of the collection of information between 30 and 60 days after publication, comments on the information collection should be submitted not later than December 20, 2007. Comments are specifically requested concerning: • Whether the proposed collection of information is necessary for the proper performance of the functions of the Alcohol and Tobacco Tax and Trade Bureau, including whether the information will have practical utility; • The accuracy of the estimated burden associated with the proposed collection of information (see below); • How to enhance the quality, utility, and clarity of the information to be collected; • How to minimize the burden of complying with the proposed collection of information, including the application of automated collection techniques or other forms of information technology; and • Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. The collection of information in this proposed regulation is in 27 CFR 9.11 and 9.12. This information is required to petition TTB to establish a new AVA or to change an existing AVA. This information will be used to verify evidence sources and to determine whether the information is sufficient to begin the rulemaking process (that is, proceed to a notice of proposed rulemaking). The collection of information is required to obtain a benefit. The likely respondents are non-profit institutions and small businesses or organizations. • *Estimated total annual reporting and/or recordkeeping burden:* 2,398 hours. • *Estimated average annual burden hours per respondent:* 218 hours. • *Estimated number of respondents:* 11 per year. • *Estimated annual frequency of responses:* 1. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB. Drafting Information Rita D. Butler of the Regulations and Rulings Division drafted this document. List of Subjects 27 CFR Part 4 Advertising, Customs duties and inspection, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements, Trade practices, and Wine. 27 CFR Part 9 Wine. 27 CFR Part 70 Administrative practice and procedure, Claims, Excise taxes, Freedom of information, Law enforcement, Penalties, Reporting and recordkeeping requirements, and Surety bonds. Proposed Amendments to the Regulations For the reasons discussed in the preamble, TTB proposes to amend 27 CFR, chapter I, parts 4, 9, and 70, as follows: PART 4—LABELING AND ADVERTISING OF WINE 1. The authority citation for part 4 continues to read as follows: Authority: 27 U.S.C. 205, unless otherwise noted. 2. In § 4.25, paragraphs (e)(1)(i) and (e)(2) are revised to read as follows: § 4.25 Appellations of origin.
(e)*Viticultural area* —(1) *Definition* —(i) *American wine.* A delimited grape growing region having distinguishing features as described in part 9 of this chapter and a name and a delineated boundary as established in part 9 of this chapter.
(2)*Establishment of American viticultural areas.* A petition for the establishment of an American viticultural area may be made to the Administrator by any interested party, pursuant to part 9 and § 70.701(c) of this chapter. The petition must be made in written form and must contain the information specified in § 9.12 of this chapter. 3. In § 4.39, paragraphs (i)(1) and (i)(2) are revised, paragraph (i)(3) is redesignated as paragraph (i)(4), and a new paragraph (i)(3) is added, to read as follows: § 4.39 Prohibited practices.
(i)*Geographic brand names* .
(1)Except as provided in paragraph (i)(2) or
(3)of this section, a brand name of viticultural significance may not be used unless the wine meets the appellation of origin requirements for the geographic area named.
(2)For brand names used in existing certificates of label approval issued prior to July 7, 1986:
(i)The wine shall be labeled with an appellation of origin in accordance with § 4.34(b) of this chapter as to location and size of type of either:
(A)A county or a viticultural area, if the brand name bears the name of a geographic area smaller than a state; or
(B)A state, county or a viticultural area, if the brand name bears a state name; or
(ii)The wine shall be labeled with some other statement which the appropriate TTB officer finds to be sufficient to dispel the impression that the geographic area suggested by the brand name is indicative of the origin of the wine.
(3)Brand names that do not meet the requirements of paragraph (i)(2) of this section and that contain the name of a viticultural area or other term of viticultural significance established under part 9 of this chapter on or after [INSERT EFFECTIVE DATE OF FINAL RULE] may be used in conjunction with information which the appropriate TTB officer finds to be sufficient to dispel the impression that the geographic area suggested by the brand name is indicative of the origin of the wine, provided that the brand name:
(i)Was used in an existing certificate of label approval issued prior to the 5-year period immediately preceding receipt of the perfected petition for establishment of the viticultural area; and
(ii)Was in actual commercial use on labels for at least 3 years during that 5-year period. PART 9—AMERICAN VITICULTURAL AREAS 4. The authority citation for part 9 continues to read as follows: Authority: 27 U.S.C. 205. 5. A new § 9.0 is added before Subpart A to read as follows: § 9.0 Scope. The regulations in this part relate to American viticultural areas created under the authority of the Federal Alcohol Administration Act and referred to in § 4.25(e) of this chapter. 6. Subparts A and B are revised to read as follows: Subpart A—General Provisions § 9.1 Definitions.
(a)*General* . For purposes of this part, and unless the specific context otherwise requires, the following terms shall have the meanings indicated: *Administrator* . The Administrator, Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury, Washington, DC. *American viticultural area* . A viticultural area as defined in § 4.25(e)(1)(i) of this chapter. *Appropriate TTB officer* . An officer or employee of the Alcohol and Tobacco Tax and Trade Bureau authorized to perform any functions relating to the administration or enforcement of this part by TTB Order 1135.9, Delegation of the Administrator's Authorities in 27 CFR Part 9, American Viticultural Areas. *Approved map* . The U.S.G.S. map(s) used to define the boundary of an approved AVA. *AVA* . An American viticultural area. *Perfected petition* . A petition containing all of the evidence meeting the requirements of § 9.12 and containing sufficient supporting information for TTB to decide whether or not to proceed with rulemaking to establish a new AVA or to change an existing AVA. *Person* . An individual, partnership, association, corporation, or other entity. *Petition* . A written request to establish a new AVA or to change an existing AVA, signed by the petitioner or an authorized agent of the petitioner, and submitted in accordance with this part and § 70.701(c) of this chapter. *Petitioner* . An individual or entity that submits a petition to TTB. *Term of viticultural significance* . A term recognized under § 4.39(i)(3) of this chapter. *TTB* . The Alcohol and Tobacco Tax and Trade Bureau, Department of the Treasury, Washington, DC. *U.S.G.S* . The United States Geological Survey.
(b)*Use of other terms* . Any other term defined in the Federal Alcohol Administration Act and used in this part shall have the same meaning assigned to it by that Act. § 9.2 Territorial extent. This part applies to the several States of the United States, the District of Columbia, and Puerto Rico. § 9.3 Delegations of the Administrator. Most of the regulatory authorities of the Administrator contained in this part are delegated to appropriate TTB officers. Those TTB officers are specified in TTB Order 1135.9, Delegation of the Administrator's Authorities in 27 CFR Part 9, American Viticultural Areas. You may obtain a copy of this order by accessing the TTB Web site ( *http://www.ttb.gov* ) or by mailing a request to the Alcohol and Tobacco Tax and Trade Bureau, National Revenue Center, 550 Main Street, Room 1516, Cincinnati, OH 45202. Subpart B—AVA Petitions § 9.11 Submission of AVA petitions.
(a)*Procedure for petitioner* . Any person may submit an AVA petition to TTB to establish a grape-growing region as a new AVA, to change the boundary of an existing AVA, or to change the name of an existing AVA. The petitioner is responsible for including with the petition all of the information specified in § 9.12. The person submitting the petition is also responsible for providing timely and complete responses to TTB requests for additional information to support the petition.
(b)*How and where to submit an AVA petition* . The AVA petition may be sent to TTB using the U.S. Postal Service or a private delivery service. A petition sent through the U.S. Postal Service should be addressed to: Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street, NW., Washington, DC 20220. A petition sent via a private delivery service should be directed to: Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, Suite 200E, 1310 G Street, NW., Washington, DC 20005.
(c)*Purpose and effect of submission of AVA petitions* . The submission of a petition under this subpart is intended to provide TTB with sufficient documentation to propose the establishment of a new AVA or to propose changing the name or boundary of an existing AVA. After considering the petition evidence and any other relevant information, TTB shall decide what action to take in response to a petition and shall so advise the petitioner. Nothing in this chapter shall, or shall be interpreted to, compel any Department of the Treasury official to proceed to rulemaking in response to a submitted petition. § 9.12 AVA petition requirements.
(a)*Establishment of an AVA in general* . A petition for the establishment of a new AVA must include all of the evidentiary materials and other information specified in this section. The petition must stand on its own and require no independent verification or research by TTB.
(1)*Name evidence.* The name identified for the proposed AVA must be currently and directly associated with an area in which viticulture exists. All of the area within the proposed AVA boundary must be nationally or locally known by the name specified in the petition, although the use of that name may extend beyond the proposed AVA boundary. The name evidence must conform to the following rules:
(i)*Name usage.* The petition must completely explain, in narrative form, the manner in which the name is used for the area covered by the proposed AVA.
(ii)*Source of name and name evidence.* The name and the evidence in support of it must come from sources independent of the petitioner. Appropriate name evidence sources include, but are not limited to, historical and modern government or commercial maps, books, newspapers, magazines, tourist and other promotional materials, local business or school names, and road names. Whenever practicable, the petitioner must include with the petition copies of the name evidence materials, appropriately cross-referenced in the petition narrative. Although anecdotal information by itself is not sufficient, statements taken from local residents with knowledge of the name and its use may also be included to support other name evidence.
(2)*Boundary evidence.* The petition must explain in detail the basis for defining the boundary of the proposed AVA as set forth in the petition. This explanation must have reference to the name evidence and other distinguishing features information required under this section. In support of the proposed boundary, the petition must outline the commonalities or similarities within that boundary and must explain with specificity how those elements are different in the adjacent areas outside that boundary.
(3)*Distinguishing features.* The petition must provide, in narrative form, a description of the common or similar features of the proposed AVA affecting viticulture that make it distinctive. The petition must also explain with specificity in what way these features affect viticulture and how they are distinguished viticulturally from features associated with adjacent areas outside the proposed AVA boundary. For purposes of this section, information relating to distinguishing features affecting viticulture includes the following:
(i)*Climate.* Temperature, precipitation, wind, fog, solar orientation and radiation, and other climate information;
(ii)*Geology.* Underlying formations, landforms, and such geophysical events as earthquakes, eruptions, and major floods;
(iii)*Soils.* Soil series or phases of a soil series, denoting parent material, texture, slope, permeability, soil reaction, drainage, and fertility;
(iv)*Physical features.* Flat, hilly, or mountainous topography, geographical formations, bodies of water, watersheds, irrigation resources, and other physical features; and
(v)*Elevation.* Minimum and maximum elevations.
(4)*Maps and boundary description* —(i) *Maps.* The petitioner must submit with the petition, in an appropriate scale, the U.S.G.S. map(s) showing the location of the proposed AVA. The exact boundary of the AVA must be prominently and clearly drawn on the maps without obscuring the underlying features that define the boundary line. U.S.G.S. maps may be obtained from the U.S. Geological Survey, Branch of Distribution. If the map name is not known, the petitioner may request a map index by State.
(ii)*Boundary description.* The petition must include a detailed narrative description of the proposed AVA boundary based on U.S.G.S. map markings. This description must have a specific beginning point, must proceed unbroken from that point in a clockwise direction, and must return to that beginning point to complete the boundary description. The boundary description must refer to easily discernable reference points on the U.S.G.S. maps. The proposed AVA boundary description may rely on any of the following map features:
(A)State, county, township, forest, and other political entity lines;
(B)Highways, roads (including unimproved roads), and trails;
(C)Contour or elevation lines;
(D)Natural geographical features, including rivers, streams, creeks, ridges, and marked elevation points (such as summits or benchmarks);
(E)Human-made features (such as bridges, buildings, windmills, or water tanks); and
(F)Straight lines between marked intersections, human-made features, or other map points.
(b)*AVAs within AVAs.* If the petition proposes the establishment of a new AVA entirely within, or overlapping, an existing AVA, the evidence submitted under paragraph
(a)of this section must include information that both identifies the attributes of the proposed AVA that are consistent with the existing AVA and explains how the proposed AVA is sufficiently distinct from the existing AVA and therefore appropriate for separate recognition. If the petition proposes the establishment of a new AVA that is larger than, and encompasses, all of one or more existing AVAs, the evidence submitted under paragraph
(a)of this section must include information addressing whether, and to what extent, the attributes of the proposed AVA are consistent with those of the existing AVA(s). In any case in which an AVA would be created entirely within another AVA, whether by the establishment of a new, larger AVA or by the establishment of a new AVA within an existing one, the petition must dispel any apparent inconsistency or explain why it is acceptable. When a smaller AVA has name recognition and features that so clearly distinguish it from a larger AVA that surrounds it, TTB may determine in the course of the rulemaking that it is not part of the larger AVA and that wine produced from grapes grown within the smaller AVA would not be entitled to use the name of the larger AVA as an appellation of origin or in a brand name.
(c)*Modification of an existing AVA* —(1) *Boundary change.* If a petition seeks to change the boundary of an existing AVA, the petitioner must include with the petition all relevant evidence and other information specified for a new AVA petition in paragraphs
(a)and
(b)of this section. This evidence or information must include, at a minimum, the following:
(i)*Name evidence.* If the proposed change involves an expansion of the existing boundary, the petition must show how the name of the existing AVA also applies to the expansion area. If the proposed change would result in a decrease in the size of an existing AVA, the petition must explain the extent to which the AVA name does not apply to the excluded area.
(ii)*Distinguishing features.* The petition must demonstrate that the area covered by the proposed change has, or does not have, distinguishing features affecting viticulture that are essentially the same as those of the existing AVA. If the proposed change involves an expansion of the existing AVA, the petition must demonstrate that the area covered by the expansion has the same distinguishing features as those of the existing AVA and has different features from those of the area outside the proposed, new boundary. If the proposed change would result in a decrease in the size of an existing AVA, the petition must explain how the distinguishing features of the excluded area are different from those within the boundary of the smaller AVA. In all cases the distinguishing features must affect viticulture.
(iii)*Boundary evidence and description.* The petition must explain how the boundary of the existing AVA was incorrectly or incompletely defined or is no longer accurate due to new evidence or changed circumstances, with reference to the name evidence and distinguishing features of the existing AVA and of the area affected by the proposed boundary change. The petition must include the appropriate U.S.G.S. maps with the proposed boundary change drawn on them and must provide a detailed narrative description of the changed boundary.
(2)*Name change.* If a petition seeks to change the name of an existing AVA, the petition must establish the suitability of that name change by providing the name evidence specified in paragraph (a)(1) of this section. § 9.13 Initial processing of AVA petitions.
(a)*TTB notification to petitioner of petition receipt.* The appropriate TTB officer will acknowledge receipt of a submitted petition. This notification will be in a letter sent to the petitioner within 30 days of receipt of the petition.
(b)*Acceptance of a perfected petition or return of a deficient petition to the petitioner.* The appropriate TTB officer will perform an initial review of the petition to determine whether it is a perfected petition. If the petition is not perfected, the appropriate TTB officer will return it to the petitioner without prejudice to resubmission in perfected form. If the petition is perfected, TTB will decide whether to proceed with rulemaking under § 9.14 and will advise the petitioner in writing of that decision. If TTB decides to proceed with rulemaking, TTB will advise the petitioner of the date of receipt of the perfected petition. If TTB decides not to proceed with rulemaking, TTB will advise the petitioner of the reasons for that decision.
(c)*Notice of pending petition.* When a perfected petition is accepted for rulemaking, TTB will place a notice to that effect on the TTB Web site. § 9.14 AVA rulemaking process.
(a)*Notice of proposed rulemaking.* If TTB determines that rulemaking in response to a petition is appropriate, TTB will prepare and publish a notice of proposed rulemaking
(NPRM)in the **Federal Register** to solicit public comments on the petitioned-for AVA action.
(b)*Final action.* Following the close of the NPRM comment period, TTB will review any submitted comments and any other available relevant information and will take one of the following actions:
(1)Prepare a final rule for publication in the **Federal Register** adopting the proposed AVA action, with or without changes;
(2)Prepare a notice for publication in the **Federal Register** withdrawing the proposal and setting forth the reasons for the withdrawal. Reasons for withdrawal of a proposal must include at least one of the following:
(i)The extent of viticulture within the proposed boundary is not sufficient to constitute a grape-growing region as specified in § 9.11(a); or
(ii)The name, boundary, or distinguishing features evidence does not meet the standards for such evidence set forth in § 9.12; or
(iii)The petitioned-for action would be inconsistent with one of the purposes of the Federal Alcohol Administration Act or any other Federal statute or regulation or would be otherwise contrary to the public interest;
(3)Prepare a new NPRM for publication in the **Federal Register** setting forth a modified AVA action for public comment; or
(4)Take any other action deemed appropriate by TTB. § 9.22 [Amended] 7. Section 9.22 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Augusta’ is a term of viticultural significance.” § 9.23 [Amended] 8. Section 9.23 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Napa’ and ‘Napa Valley’ are terms of viticultural significance.” § 9.24 [Amended] 9. Section 9.24 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Chalone’ is a term of viticultural significance.” § 9.25 [Amended] 10. Section 9.25 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘San Pasqual’ and ‘San Pasqual Valley’ are terms of viticultural significance.” § 9.26 [Amended] 11. Section 9.26 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Guenoc’ and ‘Guenoc Valley’ are terms of viticultural significance.” § 9.27 [Amended] 12. Section 9.27 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Lime Kiln Valley’ is a term of viticultural significance.” § 9.28 [Amended] 13. Section 9.28 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Santa Maria Valley’ is a term of viticultural significance.” § 9.29 [Amended] 14. Section 9.29 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sonoma’ and ‘Sonoma Valley’ are terms of viticultural significance.” § 9.30 [Amended] 15. Section 9.30 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘North Coast’ is a term of viticultural significance.” § 9.31 [Amended] 16. Section 9.31 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Santa Cruz’ and ‘Santa Cruz Mountains’ are terms of viticultural significance.” § 9.32 [Amended] 17. Section 9.32 is amended by revising the sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Carneros’ and ‘Los Carneros’ are terms of viticultural significance.” § 9.33 [Amended] 18. Section 9.33 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Fennville’ is a term of viticultural significance.” § 9.34 [Amended] 19. Section 9.34 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Finger Lakes’ is a term of viticultural significance.” § 9.35 [Amended] 20. Section 9.35 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Edna Valley’ is a term of viticultural significance.” § 9.36 [Amended] 21. Section 9.36 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘McDowell Valley’ is a term of viticultural significance.” § 9.37 [Amended] 22. Section 9.37 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Shenandoah’, ‘Shenandoah Valley’, and ‘California Shenandoah Valley’ are terms of viticultural significance.” § 9.38 [Amended] 23. Section 9.38 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Cienega’ and ‘Cienega Valley’ are terms of viticultural significance.” § 9.39 [Amended] 24. Section 9.39 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Paicines’ is a term of viticultural significance.” § 9.40 [Amended] 25. Section 9.40 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Leelanau’ and ‘Leelanau Peninsula’ are terms of viticultural significance.” § 9.41 [Amended] 26. Section 9.41 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Lancaster Valley’ is a term of viticultural significance.” § 9.42 [Amended] 27. Section 9.42 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Cole Ranch’ is a term of viticultural significance.” § 9.43 [Amended] 28. Section 9.43 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Rocky Knob’ is a term of viticultural significance.” § 9.44 [Amended] 29. Section 9.44 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Solano County Green Valley’ is a term of viticultural significance.” § 9.45 [Amended] 30. Section 9.45 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Suisun Valley’ is a term of viticultural significance.” § 9.46 [Amended] 31. Section 9.46 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Livermore Valley’ is a term of viticultural significance.” § 9.47 [Amended] 32. Section 9.47 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Hudson River’ and ‘Hudson River Region’ are terms of viticultural significance.” § 9.48 [Amended] 33. Section 9.48 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Monticello’ is a term of viticultural significance.” § 9.49 [Amended] 34. Section 9.49 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Delaware Valley’ and ‘Central Delaware Valley’ are terms of viticultural significance.” § 9.50 [Amended] 35. Section 9.50 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Temecula’ and ‘Temecula Valley’ are terms of viticultural significance.” § 9.51 [Amended] 36. Section 9.51 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Isle St. George’ is a term of viticultural significance.” § 9.52 [Amended] 37. Section 9.52 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Chalk Hill’ is a term of viticultural significance.” § 9.53 [Amended] 38. Section 9.53 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Alexander Valley’ is a term of viticultural significance.” § 9.54 [Amended] 39. Section 9.54 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Santa Ynez’ and ‘Santa Ynez Valley’ are terms of viticultural significance.” § 9.55 [Amended] 40. Section 9.55 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Bell Mountain’ is a term of viticultural significance.” § 9.56 [Amended] 41. Section 9.56 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘San Lucas’ is a term of viticultural significance.” § 9.57 [Amended] 42. Section 9.57 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sonoma’, ‘Sonoma County’, and ‘Sonoma County Green Valley’ are terms of viticultural significance.” § 9.58 [Amended] 43. Section 9.58 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Carmel Valley’ is a term of viticultural significance.” § 9.59 [Amended] 44. Section 9.59 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Arroyo Seco’ is a term of viticultural significance.” § 9.60 [Amended] 45. Section 9.60 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Shenandoah’ and ‘Shenandoah Valley’ are terms of viticultural significance.” § 9.61 [Amended] 46. Section 9.61 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘El Dorado’ is a term of viticultural significance.” § 9.62 [Amended] 47. Section 9.62 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Loramie Creek’ is a term of viticultural significance.” § 9.63 [Amended] 48. Section 9.63 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Linganore’ is a term of viticultural significance.” § 9.64 [Amended] 49. Section 9.64 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Dry Creek’ and ‘Dry Creek Valley’ are terms of viticultural significance.” § 9.65 [Amended] 50. Section 9.65 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘North Fork of Roanoke’ is a term of viticultural significance.” § 9.66 [Amended] 51. Section 9.66 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Russian River’ and ‘Russian River Valley’ are terms of viticultural significance.” § 9.67 [Amended] 52. Section 9.67 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Catoctin’ is a term of viticultural significance.” § 9.68 [Amended] 53. Section 9.68 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Merritt Island’ is a term of viticultural significance.” § 9.69 [Amended] 54. Section 9.69 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Yakima’ and ‘Yakima Valley’ are terms of viticultural significance.” § 9.70 [Amended] 55. Section 9.70 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sonoma’ and ‘Northern Sonoma’ are terms of viticultural significance.” § 9.71 [Amended] 56. Section 9.71 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Hermann’ is a term of viticultural significance.” § 9.72 [Amended] 57. Section 9.72 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Southeastern New England’ is a term of viticultural significance.” § 9.73 [Amended] 58. Section 9.73 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Martha's Vineyard’ is a term of viticultural significance.” § 9.74 [Amended] 59. Section 9.74 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Columbia Valley’ is a term of viticultural significance.” § 9.75 [Amended] 60. Section 9.75 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Central Coast’ is a term of viticultural significance.” § 9.76 [Amended] 61. Section 9.76 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Knights Valley’ is a term of viticultural significance.” § 9.77 [Amended] 62. Section 9.77 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Altus’ is a term of viticultural significance.” § 9.78 [Amended] 63. Section 9.78 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Ohio River’ and ‘Ohio River Valley’ are terms of viticultural significance.” § 9.79 [Amended] 64. Section 9.79 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Lake Michigan’ and ‘Lake Michigan Shore’ are terms of viticultural significance.” § 9.80 [Amended] 65. Section 9.80 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘York Mountain’ is a term of viticultural significance.” § 9.81 [Amended] 66. Section 9.81 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Fiddletown’ is a term of viticultural significance.” § 9.82 [Amended] 67. Section 9.82 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Potter Valley’ is a term of viticultural significance.” § 9.83 [Amended] 68. Section 9.83 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Lake Erie’ is a term of viticultural significance.” § 9.84 [Amended] 69. Section 9.84 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Paso Robles” is a term of viticultural significance.” § 9.85 [Amended] 70. Section 9.85 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Willow Creek’ is a term of viticultural significance.” § 9.86 [Amended] 71. Section 9.86 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Anderson Valley’ is a term of viticultural significance.” § 9.87 [Amended] 72. Section 9.87 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Grand River Valley’ is a term of viticultural significance.” § 9.88 [Amended] 73. Section 9.88 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Pacheco Pass’ is a term of viticultural significance.” § 9.89 [Amended] 74. Section 9.89 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Umpqua’ and ‘Umpqua Valley’ are terms of viticultural significance.” § 9.90 [Amended] 75. Section 9.90 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Willamette’ and ‘Willamette Valley’ are terms of viticultural significance.” § 9.91 [Amended] 76. Section 9.91 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Walla Walla’ and ‘Walla Walla Valley’ are terms of viticultural significance.” § 9.92 [Amended] 77. Section 9.92 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Madera’ is a term of viticultural significance.” § 9.93 [Amended] 78. Section 9.93 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mendocino’ is a term of viticultural significance.” § 9.94 [Amended] 79. Section 9.94 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Howell Mountain’ is a term of viticultural significance.” § 9.95 [Amended] 80. Section 9.95 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Clarksburg’ is a term of viticultural significance.” § 9.96 [Amended] 81. Section 9.96 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mississippi Delta’ is a term of viticultural significance.” § 9.97 [Amended] 82. Section 9.97 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sonoita’ is a term of viticultural significance.” § 9.98 [Amended] 83. Section 9.98 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Monterey’ is a term of viticultural significance.” § 9.99 [Amended] 84. Section 9.99 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Clear Lake’ is a term of viticultural significance.” § 9.100 [Amended] 85. Section 9.100 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mesilla’ and ‘Mesilla Valley’ are terms of viticultural significance.” § 9.101 [Amended] 86. Section 9.101 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘The Hamptons', ‘Long Island', and ‘The Hamptons, Long Island’ are terms of viticultural significance.” § 9.102 [Amended] 87. Section 9.102 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sonoma’ and ‘Sonoma Mountain’ are terms of viticultural significance.” § 9.103 [Amended] 88. Section 9.103 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mimbres Valley’ is a term of viticultural significance.” § 9.104 [Amended] 89. Section 9.104 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘South Coast’ is a term of viticultural significance.” § 9.105 [Amended] 90. Section 9.105 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Cumberland Valley’ is a term of viticultural significance.” § 9.106 [Amended] 91. Section 9.106 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Yuba’ and ‘North Yuba’ are terms of viticultural significance.” § 9.107 [Amended] 92. Section 9.107 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Lodi’ is a term of viticultural significance.” § 9.108 [Amended] 93. Section 9.108 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Ozark Mountain’ is a term of viticultural significance.” § 9.109 [Amended] 94. Section 9.109 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘George Washington Birthplace’ and ‘Northern Neck George Washington Birthplace’ are terms of viticultural significance.” § 9.110 [Amended] 95. Section 9.110 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘San Benito’ is a term of viticultural significance.” § 9.111 [Amended] 96. Section 9.111 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Kanawha', ‘Kanawha River', and ‘Kanawha River Valley’ are terms of viticultural significance.” § 9.112 [Amended] 97. Section 9.112 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Arkansas Mountain’ is a term of viticultural significance.” § 9.113 [Amended] 98. Section 9.113 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Long Island’ and ‘North Fork of Long Island’ are terms of viticultural significance.” § 9.114 [Amended] 99. Section 9.114 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Old Mission Peninsula’ is a term of viticultural significance.” § 9.115 [Amended] 100. Section 9.115 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Ozark Highlands’ is a term of viticultural significance.” § 9.116 [Amended] 101. Section 9.116 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sonoma’ and ‘Sonoma Coast’ are terms of viticultural significance.” § 9.117 [Amended] 102. Section 9.117 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Stags Leap District’ is a term of viticultural significance.” § 9.118 [Amended] 103. Section 9.118 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Ben Lomond Mountain’ is a term of viticultural significance.” § 9.119 [Amended] 104. Section 9.119 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Rio Grande’, ‘Rio Grande Valley', and ‘Middle Rio Grande Valley’ are terms of viticultural significance.” § 9.120 [Amended] 105. Section 9.120 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Sierra Foothills’ is a term of viticultural significance.” § 9.121 [Amended] 106. Section 9.121 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Warren Hills’ is a term of viticultural significance.” § 9.122 [Amended] 107. Section 9.122 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Connecticut Highlands’ and ‘Western Connecticut Highlands’ are terms of viticultural significance.” § 9.123 [Amended] 108. Section 9.123 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mt. Veeder’ is a term of viticultural significance.” § 9.124 [Amended] 109. Section 9.124 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Wild Horse Valley’ is a term of viticultural significance.” § 9.125 [Amended] 110. Section 9.125 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Texas Hill Country’ and ‘Fredericksburg in the Texas Hill Country’ are terms of viticultural significance.” § 9.126 [Amended] 111. Section 9.126 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Santa Clara Valley’ is a term of viticultural significance.” § 9.127 [Amended] 112. Section 9.127 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Cayuga’ and ‘Cayuga Lake’ are terms of viticultural significance.” § 9.128 [Amended] 113. Section 9.128 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Seneca Lake’ is a term of viticultural significance.” § 9.129 [Amended] 114. Section 9.129 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Arroyo’, ‘Arroyo Grande’, and ‘Arroyo Grande Valley’ are terms of viticultural significance.” § 9.130 [Amended] 115. Section 9.130 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘San Ysidro District’ is a term of viticultural significance.” § 9.131 [Amended] 116. Section 9.131 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mt. Harlan’ is a term of viticultural significance.” § 9.132 [Amended] 117. Section 9.132 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Rogue Valley’ is a term of viticultural significance.” § 9.133 [Amended] 118. Section 9.133 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Rutherford’ is a term of viticultural significance.” § 9.134 [Amended] 119. Section 9.134 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Oakville’ is a term of viticultural significance.” § 9.135 [Amended] 120. Section 9.135 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Virginia's Eastern Shore’ is a term of viticultural significance.” § 9.136 [Amended] 121. Section 9.136 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Texas Hill’ and ‘Texas Hill Country’ are terms of viticultural significance.” § 9.137 [Amended] 122. Section 9.137 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Grand Valley’ is a term of viticultural significance.” § 9.138 [Amended] 123. Section 9.138 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Benmore Valley’ is a term of viticultural significance.” § 9.139 [Amended] 124. Section 9.139 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Santa Lucia’ and ‘Santa Lucia Highlands’ are terms of viticultural significance.” § 9.140 [Amended] 125. Section 9.140 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Atlas Peak’ is a term of viticultural significance.” § 9.141 [Amended] 126. Section 9.141 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Escondido’ and ‘Escondido Valley’ are terms of viticultural significance.” § 9.142 [Amended] 127. Section 9.142 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Bennett Valley’ is a term of viticultural significance.” § 9.143 [Amended] 128. Section 9.143 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Spring Mountain District’ is a term of viticultural significance.” § 9.144 [Amended] 129. Section 9.144 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Texas High Plains’ is a term of viticultural significance.” § 9.145 [Amended] 130. Section 9.145 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Dunnigan Hills’ is a term of viticultural significance.” § 9.146 [Amended] 131. Section 9.146 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Lake Wisconsin’ is a term of viticultural significance.” § 9.147 [Amended] 132. Section 9.147 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Hames Valley’ is a term of viticultural significance.” § 9.148 [Amended] 133. Section 9.148 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Seiad’ and ‘Seiad Valley’ are terms of viticultural significance.” § 9.149 [Amended] 134. Section 9.149 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘St. Helena’ is a term of viticultural significance.” § 9.150 [Amended] 135. Section 9.150 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Cucamonga’ and ‘Cucamonga Valley’ are terms of viticultural significance.” § 9.151 [Amended] 136. Section 9.151 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Puget Sound’ is a term of viticultural significance.” § 9.152 [Amended] 137. Section 9.152 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Malibu’, ‘Newton Canyon’, and ‘Malibu-Newton Canyon’ are terms of viticultural significance.” § 9.153 [Amended] 138. Section 9.153 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Redwood Valley’ is a term of viticultural significance.” § 9.154 [Amended] 139. Section 9.154 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Chiles Valley’ is a term of viticultural significance.” § 9.155 [Amended] 140. Section 9.155 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Texas Davis Mountains’ is a term of viticultural significance.” § 9.156 [Amended] 141. Section 9.156 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Diablo Grande’ is a term of viticultural significance.” § 9.157 [Amended] 142. Section 9.157 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘San Francisco Bay’ is a term of viticultural significance.” § 9.158 [Amended] 143. Section 9.158 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Mendocino Ridge’ is a term of viticultural significance.” § 9.159 [Amended] 144. Section 9.159 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Yorkville Highlands’ is a term of viticultural significance.” § 9.160 [Amended] 145. Section 9.160 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Yountville’ is a term of viticultural significance.” § 9.161 [Amended] 146. Section 9.161 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Oak Knoll District’, ‘Napa Valley’, and ‘Oak Knoll District of Napa Valley’ are terms of viticultural significance.” § 9.163 [Amended] 147. Section 9.163 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Salado Creek’ is a term of viticultural significance.” § 9.164 [Amended] 148. Section 9.164 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘River Junction’ is a term of viticultural significance.” § 9.165 [Amended] 149. Section 9.165 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Applegate Valley’ is a term of viticultural significance.” § 9.166 [Amended] 150. Section 9.166 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Diamond Mountain District’ is a term of viticultural significance.” § 9.167 [Amended] 151. Section 9.167 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Red Mountain’ is a term of viticultural significance.” § 9.168 [Amended] 152. Section 9.168 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Fair Play’ is a term of viticultural significance.” § 9.169 [Amended] 153. Section 9.169 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Red Hills of Lake County’ and ‘Red Hills Lake County’ are terms of viticultural significance.” § 9.170 [Amended] 154. Section 9.170 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Long Island’ is a term of viticultural significance.” § 9.171 [Amended] 155. Section 9.171 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘San Bernabe’ is a term of viticultural significance.” § 9.172 [Amended] 156. Section 9.172 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘West Elks’ is a term of viticultural significance.” § 9.173 [Amended] 157. Section 9.173 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Rockpile’ is a term of viticultural significance.” § 9.174 [Amended] 158. Section 9.174 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Yadkin’ and ‘Yadkin Valley’ are terms of viticultural significance.” § 9.176 [Amended] 159. Section 9.176 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Capay’ and ‘Capay Valley’ are terms of viticultural significance.” § 9.177 [Amended] 160. Section 9.177 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Alexandria Lakes’ is a term of viticultural significance.” § 9.178 [Amended] 161. Section 9.178 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Columbia Gorge’ is a term of viticultural significance.” § 9.179 [Amended] 162. Section 9.179 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Southern Oregon’ is a term of viticultural significance.” § 9.180 [Amended] 163. Section 9.180 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Dundee’ and ‘Dundee Hills’ are terms of viticultural significance.” § 9.181 [Amended] 164. Section 9.181 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘McMinnville’ is a term of viticultural significance.” § 9.182 [Amended] 165. Section 9.182 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Ribbon Ridge’ is a term of viticultural significance.” § 9.183 [Amended] 166. Section 9.183 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Yamhill-Carlton District’ is a term of viticultural significance.” § 9.184 [Amended] 167. Section 9.184 is amended by adding a sentence at the end of paragraph
(a)to read as follows: “For purposes of part 4 of this chapter, ‘Trinity Lakes” is a term of viticultural significance.” PART 70—PROCEDURE AND ADMINISTRATION 168. The authority citation for part 70 continues to read as follows: Authority: 5 U.S.C. 301 and 552; 26 U.S.C. 4181, 4182, 5146, 5203, 5207, 5275, 5367, 5415, 5504, 5555, 5684(a), 5741, 5761(b), 5802, 6020, 6021, 6064, 6102, 6155, 6159, 6201, 6203, 6204, 6301, 6303, 6311, 6313, 6314, 6321, 6323, 6325, 6326, 6331-6343, 6401-6404, 6407, 6416, 6423, 6501-6503, 6511, 6513, 6514, 6532, 6601, 6602, 6611, 6621, 6622, 6651, 6653, 6656-6658, 6665, 6671, 6672, 6701, 6723, 6801, 6862, 6863, 6901, 7011, 7101, 7102, 7121, 7122, 7207, 7209, 7214, 7304, 7401, 7403, 7406, 7423, 7424, 7425, 7426, 7429, 7430, 7432, 7502, 7503, 7505, 7506, 7513, 7601-7606, 7608-7610, 7622, 7623, 7653, 7805. § 70.701 [Amended] 169. Section 70.701 is amended by adding a sentence at the end of paragraph
(c)to read as follows: “A petition to establish a new American viticultural area or to modify an existing American viticultural area is subject to the rules in part 9 of this chapter.” Signed: October 18, 2007. John J. Manfreda, Administrator. Approved: November 7, 2007. Timothy E. Skud, Deputy Assistant Secretary (Tax, Trade, and Tariff Policy). [FR Doc. E7-22717 Filed 11-19-07; 8:45 am] BILLING CODE 4810-31-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2007-0064] RIN 1625-AA00 Safety Zone: City of West Haven Fireworks, Bradley Point, West Haven, CT AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes to amend the permanent safety zone for the City of West Haven Fireworks by establishing the zone around a fireworks launch site at the approximate position 41°15′7″ N, 72°57′26″ W. This change to the zone would allow the zone to be established around the launch site, whether it is on a barge or on shore. Establishment of this safety zone is necessary to protect recreational vessel traffic, spectators, and those operating the fireworks display. DATES: Comments and related material must reach the Coast Guard on or before January 22, 2008. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG-2007-0064 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)Online: *http://www.regulations.gov.*
(2)Mail: Docket Management Facility (M-30), U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
(3)Hand delivery: Room W12-140 on the Ground Floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
(4)Fax: 202-493-2251. FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed rule, call Lieutenant Douglas Miller, Chief, Waterways Management Division, Coast Guard Sector Long Island Sound at
(203)468-4596. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments We encourage you to participate in this rulemaking by submitting comments and related material. All comments received will be posted, without change, to *http://www.regulations.gov* and will include any personal information you have provided. We have an agreement with the Department of Transportation
(DOT)to use the Docket Management Facility. Please see DOT's “Privacy Act” paragraph below. Submitting Comments If you submit a comment, please include the docket number for this rulemaking (USCG-2007-0064), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name and a mailing address, an e-mail address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, please submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. Viewing Comments and Documents To view comments, as well as documents mentioned in this preamble as being available in the docket, go to *http://www.regulations.gov* at any time, click on “Search for Dockets,” and enter the docket number for this rulemaking (USCG-2007-0064) in the Docket ID box, and click enter. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477), or you may visit *http://DocketsInfo.dot.gov.* Public Meeting We do not now plan to hold a public meeting. But you may submit a request for one to Coast Guard Sector Long Island Sound at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the **Federal Register** . Background and Purpose The City of West Haven, Connecticut, holds an annual fireworks display off of Bradley Point in New Haven harbor. To protect the maritime public from the hazards associated with the fireworks display, a permanent safety zone was established and the regulation is currently is found at 33 CFR 165.151(a)(5). The regulation states that all the waters of New Haven Harbor within a 1200-foot radius of the fireworks barge, at the approximate position 41°15′7″ N, 72°57′26″ W, be included in the regulated area. The event organizers have determined that at times the fireworks may need to be launched from a site on land rather than only from a barge. The new regulation would include all the waters of New Haven Harbor within a 1200-foot radius of the fireworks launch site, at the approximate position 41°15′7″ N, 72°57′26″ W. This change to the permanent safety zone would cover those instances when the fireworks are launched from land or a barge as opposed to only being launched from a barge. Discussion of Proposed Rule The Coast Guard proposes to amend the regulation at 33 CFR 165.151(a)(5) to replace the word “barge” with the word “site”. This change would allow the safety zone to be established upon the navigable waters in a 1200-foot radius of the fireworks launch site, whether it is from a barge or from land. The establishment of this safety zone around either launch site is necessary to protect the maritime public, spectators and fireworks technicians from the hazards associated with the fireworks display by keeping all vessels and persons outside of the safety zone unless they have authorization from the Captain of the Port, Long Island Sound. Regulatory Evaluation This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. This regulation may have some impact on the public, but the potential impact will be minimized for the following reasons: The zone would only be enforced for a temporary period on the day of the event and vessels may transit in all areas around the zone at all times. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which may be small entities: The owner or operators of vessels intending to transit or anchor in the vicinity of Bradley Point on the day of the event. For the reasons outlined in the Regulatory Evaluation section above, this rule will not have a significant impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Lieutenant Douglas Miller, Chief, Waterways Management Division, Coast Guard Sector Long Island Sound at
(203)468-4596. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This proposed rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is not likely to have a significant effect on the human environment. A preliminary “Environmental Analysis Check List” supporting this preliminary determination is available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226 and 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191 and 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Amend § 165.151 by revising paragraph (a)(5) to read as follows: § 165.151 Safety Zones; Long Island Sound annual fireworks displays.
(a)* * *
(5)City of West Haven Fireworks Safety Zone. All waters of New Haven Harbor on Long Island Sound off Bradley Point within a 1200-foot radius of the fireworks launch site in approximate position 41°15′7″ N, 72°57′26″ W. Dated: October 25, 2007. D.A. Ronan, Captain, U.S. Coast Guard Captain of the Port, Long Island Sound. [FR Doc. E7-22613 Filed 11-19-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF THE INTERIOR National Park Service 36 CFR Part 7 RIN 1024-AD53 Special Regulations; Areas of the National Park System AGENCY: National Park Service, Interior ACTION: Proposed rule. SUMMARY: The National Park Service is proposing this rule to provide for the protection of the Western Snowy Plover (Charadrius alexandrinus nivosus), a species listed as threatened under the Endangered Species Act. Western Snowy Plovers overwinter within Golden Gate National Recreation Area (GGNRA) at both Crissy Field and Ocean Beach. This rulemaking will provide temporary protection for two areas until a permanent determination is made through the planning process for the entire park. The park is developing a Dog Management Plan/Environmental Impact Statement
(EIS)and special regulations for dog management at GGNRA is expected to be completed by winter 2009. DATES: Comments must be received by January 22, 2008. ADDRESSES: You may submit comments, identified by the number RIN 1024-AD53, by any of the following methods: — *Federal rulemaking portal:* *http://www.regulations.gov* . Follow the instructions for submitting comments. —Mail or hand delivery to Superintendent, Golden Gate National Recreation Area, Fort Mason, Building 201, San Francisco, CA 94123. Attention: Snowy Plover Protection Rule. FOR FURTHER INFORMATION CONTACT: Brian O'Neill, General Superintendent, Golden Gate National Recreation Area, Fort Mason, Building 201, San Francisco, CA 94123.
(415)561-4728. SUPPLEMENTARY INFORMATION: Background In November 2006 and July 2007, Golden Gate National Recreation Area (GGNRA) adopted emergency regulatory provisions under 36 CFR 1.5, requiring all dogs to be on-leash on a portion of Crissy Field designated as the Wildlife Protection Area
(WPA)and on a portion of Ocean Beach designated as the Snowy Plover Protection Area (SPPA). The emergency restrictions in these two areas were established for the protection of the federally listed Western Snowy Plover. These emergency restrictions are temporary and necessary until the completion of this rulemaking. The Western Snowy Plover was listed as a threatened species under the Endangered Species Act (“Act”) in 1993. The plover's listing was due, in part, to significant declines in population numbers and distribution attributed to habitat loss and increased predation resulting from human disturbance and development. Among other things, the plover's threatened status affords it protection from harassment. The regulations that implement the Act define “harass” as “an intentional or negligent act or omission which creates the likelihood of injury to wildlife by annoying it to such an extent as to significantly disrupt normal behavior patterns which include, but are not limited to, breeding, feeding, or sheltering.” Snowy Plovers weigh less than two ounces and because of their small size, cryptic habits, and coloration, are hard to see with the untrained eye. Plovers feed on invertebrates found in the wet sand, amongst surf-cast kelp and debris within the intertidal zone, and in dry sandy areas or amidst low foredune vegetation above the high tide line. When resting, Snowy Plovers usually take shelter in footprints, vehicle tracks, or the lee of kelp, driftwood or sparsely vegetated low foredunes on the widest areas of beaches. Snowy Plovers are particular in their habitat choices; they need to rest and feed on wide, flat, open beaches where they can see potential predators approaching. These conditions are found at Crissy Field and Ocean Beach. Snowy plovers do not nest in the park; they overwinter in the park from approximately July through April. During the overwintering period, Snowy Plovers rest and feed to gather reserves necessary to successfully breed at other more suitable nesting locations up and down the Pacific coast. Snowy Plovers continue to be threatened by degradation and loss of breeding and wintering habitat caused by expanding beach-front development, encroachment of introduced European beachgrass (Ammophila arenaria), and intense recreational use of beaches. Poor reproductive success is frequently the result of human disturbance, predation, or inclement weather, These factors, combined with habitat loss, led to the overall decline in active nesting colonies and breeding and wintering populations along the Pacific coast, and prompted its federal listing as a threatened species in 1993. Snowy Plover monitoring data from the 2006-2007 overwintering season was analyzed by the NPS and compiled in an addendum to the November 2006 report, (“Addendum: 2006 Plover Monitoring”, dated June 29, 2007). Data from 2006-2007 overwintering season confirmed that even though the emergency restrictions reduced the numbers of off leash dogs, there were still high numbers of off leash dogs and dogs chasing shorebirds during the 2006-2007 overwintering season constituting an ongoing threat to Western Snowy Plovers. Increased enforcement of the restrictions during the 2007-2008 season would help to reduce this threat. Description of the Golden Gate National Recreation Area GGNRA was established in 1972. The lands that constitute GGNRA extend north of the Golden Gate Bridge (the entrance to the San Francisco and San Pablo Bays) to Tomales Bay in Marin County, and south to the San Francisco watersheds and beyond in San Mateo County. The park's legislated boundary encompasses nearly 80,000 acres of land and water, including 59 miles of bay and ocean shoreline. The GGNRA directly manages approximately 16,000 acres in Marin, San Francisco and San Mateo counties. These lands represent one of the nation's largest coastal preserves and attract 16 million visitors each year, making GGNRA one of the most heavily visited units in the National Park System. The lands encompassing GGNRA provide important habitat for many federally threatened or endangered species, as well as many other State listed and rare species. The central coast, including the San Francisco Bay Area and GGNRA, is considered one of North America's biodiversity hot spots ( *Precious Heritage: the Status of Biodiversity in the United States, Nature Conservancy* ). The California Floristic Province, which includes all of GGNRA, is identified as one of the top 25 global biodiversity hotspots in the world ( *Nature's Place: Population and the Future of Diversity, 2000 Report by Population Action International* ). GGNRA is part of the Golden Gate Biosphere Reserve, designated in 1989 in recognition of the importance of this coastal and marine ecosystem to the conservation of biodiversity, sustainable development, research and education. Purposes of Golden Gate National Recreation Area GGNRA was created from a vision to promote the enjoyment of the natural and cultural resources on the edge of urban San Francisco Bay Area communities while preserving those resources for the future. The vast natural resources that existed in the bay estuary and its environs before 1800 had, by the 1960s, been reduced to minute remnants, some of which were protected in a handful of national, state and local parks and open space. Congress recognized that the lands, now included within GGNRA, presented a unique opportunity to preserve some of the last remnants of once abundant flora and fauna. The 1972 legislation that established GGNRA, Public Law 92-589, set forth the park's mission as follows: *In order to preserve for public use and enjoyment certain areas of Marin and San Francisco Counties, California, possessing outstanding natural, historic, scenic, and recreational values, and in order to provide for the maintenance of needed recreational open space necessary to urban environment and planning, the Golden Gate National Recreation Area (hereinafter referred to as the “recreation area”) is hereby established. In the management of the recreation area, the Secretary of Interior (hereinafter referred to as the “Secretary”) shall utilize the resources in a manner which will provide for recreation and educational opportunities consistent with sound principles of land use planning and management. In carrying out the provisions of this Act, the Secretary shall preserve the recreation area, as far as possible, in its natural setting, and protect it from development and uses which would destroy the scenic beauty and natural character of the area.* In addition, the 1972 legislation required GGNRA to manage the park in accordance with the National Park Service Organic Act of 1916 (Organic Act) (16 U.S.C. Section 1 *et seq.* ) The Organic Act requires the National Park Service to: *Promote and regulate the use of the federal areas known as national parks, monuments, and reservations hereinafter specified * * * by such means and measures as conform to the fundamental purpose of the said parks, monuments, and reservations, which purpose is to conserve the scenery and the natural and historic objects and the wild life therein and to provide for the enjoyment of the same in such manner and by such means as will leave them unimpaired for the enjoyment of future generations.* The National Park Service has promulgated policies that amplify the meaning of the Organic Act. These policies, referred to as the *2006 Management Policies,* provide mandatory guidance for all national parks. With regard to the protection of threatened and endangered species, the *2006 Management Policies* require the NPS to “fully meet its obligations under the NPS Organic Act and the Endangered Species Act to both proactively conserve listed species and prevent detrimental effects on these species.” One of the means to achieve these goals is the management of detrimental visitor use that may be negatively affecting listed species ( *2006 Management Policies* 4.4.2.3). Authority and Jurisdiction Under the Organic Act, Congress granted the NPS broad authority to regulate the use of the federal areas known as national parks. In addition, the Organic Act authorizes the NPS, through the Secretary of the Interior, to “make and publish such rules and regulations as he may deem necessary or proper for the use and management of the parks * * *.” *(16 U.S.C. 3).* *16 U.S.C. 1a-1* states, “The authorization of activities shall be conducted in light of the high public value and integrity of the National Park System and shall not be exercised in derogation of the values and purposes for which these various areas have been established * * *.” The NPS's regulatory authority over waters subject to the jurisdiction of the United States, including navigable waters, is based upon the Property Clause and, as with the United States Coast Guard's authority, Commerce Clause of the U.S. Constitution. In regard to the NPS, Congress in 1976 directed the NPS to “promulgate and enforce regulations concerning boating and other activities on or relating to waters within areas of the National Park System, including waters subject to the jurisdiction of the United States * * *.” *(16 U.S.C. 1a-2* (h)). In 1996, the NPS published a final rule (61 FR 35136 (July 5, 1996)) amending 36 CFR 1.2(a)(3) to clarify its authority to regulate activities within National Park System boundaries occurring on waters and tidelands subject to the jurisdiction of the United States. Through the authority stated above, the NPS exercises legal jurisdiction over NPS waters offshore Ocean Beach and Crissy Field. The park's legislated boundary includes all waters to 1/4 mile (1,320 feet) offshore at Ocean Beach and Crissy Field. In addition, the NPS has a lease with the State of California-State Lands Commission which provides NPS with the authority to manage tide and submerged lands to 1,000 feet offshore. The United States' jurisdiction over offshore areas at Crissy Field is further augmented by the fact that the United States holds title to the tide and submerged lands at Crissy Field extending 300 yards below low water. Regulation of Dog Walking at Crissy Field and Ocean Beach Dogs, including off-leash dogs, have been present on Ocean Beach and Crissy Field for many years. From approximately 1979 to the late 1990s, GGNRA allowed dogs to be off-leash in certain areas of the park under “voice control.” In all other areas of the park and the national park system, dogs were required to be leashed in accordance with the general regulation found at 36 CFR 2.15(a) or they were excluded altogether. In 2002, GGNRA required dogs to be on-leash throughout all areas of the park where dogs were allowed. This leash requirement was enforced for several years until it was challenged in federal court in 2004. The legal action resulted in a magistrate's ruling in 2004 that was then affirmed by the U.S. District Court for the Northern District of California in June, 2005. That ruling found that GGNRA had not followed the proper procedures in adopting the 2002 leash requirement, and required GGNRA to reinstate “voice control” for dogs in those areas of the park where it had been allowed in the past. ( *U.S.* v. *Barley,* CR-04-0408-WHA (N.D. Cal. 2005)). As a result of this ruling, off-leash, “voice-control” dog walking was reinstated in a number of locations, including Crissy Field and Ocean Beach. The ruling, however, did not restrict GGNRA's authority to protect park resources, including threatened and endangered species. For more than 100 years, Crissy Field was part of the U.S. Army base at the Presidio. Crissy Field was used as an Army maintenance and operational area and numerous buildings and facilities lined the shore. The U.S. Army transferred complete administrative jurisdiction over Crissy Field to the National Park Service in 1993. Between 1998 and 2000, GGNRA restored a 100-acre portion of Crissy Field according to plans developed and analyzed through the Crissy Field Plan Environmental Assessment
(EA)(Jones and Stokes 1996) and Finding of No Significant Impact (FONSI). The transformation of Crissy Field included restoration of coastal dunes, removal of rubble on the beach, development of new trails and a restored airfield, and construction of a 20-acre tidal marsh. The Crissy Field Plan EA/FONSI addressed dog walking and recommended designating areas for off-leash dog walking, for on-leash dog walking, and a portion of Crissy Field (the tidal marsh, the overlooks on the boardwalk crossing the marsh, and the fenced dune areas) would be closed to dogs. The dog restrictions from the EA/FONSI were adopted by the Superintendent and included in the GGNRA compendium starting in 2000. Ocean Beach is the longest stretch of sandy beach between Point Reyes National Seashore and Half Moon Bay. The federally threatened Snowy Plover resides on portions of the beach for 10 months of the year. The draft Snowy Plover Management Plan (GGNRA 1998) recommended that dogs be on-leash in what was referred to as a Snowy Plover Protection Area (SPPA), extending from Stairwell 21 to Sloat Boulevard on Ocean Beach. From 1997 until December 2004, dogs were required to be leashed within the Ocean Beach SPPA, and the requirement was included in the GGNRA compendium. Snowy Plover Monitoring Western Snow Plovers have over-wintered on Ocean Beach since at least as far back as the 1980s, and sightings have occurred on Crissy Field since the winter of 2002. GGNRA has regularly monitored Snowy Plovers at Ocean Beach since 1994 and began formal monitoring of Snowy Plovers at Crissy Field in February 2005. Data accumulated by GGNRA regarding the effects of dogs on Snowy Plovers is presented in the 2006 *Status Report: Western Snowy Plovers—Recent Changes in Human and Dog Use within the Snowy Plover Protection Area at Ocean Beach and the Wildlife Protection Area at Crissy Field* (“Report”). In the report, monitoring data from the Ocean Beach SPPA and the Crissy Field WPA documents recent increases in the number of off-leash dogs using these areas. Along with this increase in the number of off-leash dogs, there has been an increase in the number of instances of dogs chasing or flushing Western Snowy Plovers or other shorebirds. In February and March of 2006, dogs were observed chasing or flushing Western Snowy Plovers on four occasions, disturbing a total of 22 plovers, in the Ocean Beach SPPA. In the Crissy Field WPA, dogs were observed chasing or flushing more than 6 plovers over the course of four surveys in July and August of 2006. The report also describes the adverse biological effects plovers experience when flushed or chased and concluded that these effects present a serious threat to the Western Snowy Plover. Emergency Regulatory Provisions Adopted in 2006 In response to the monitoring findings that off-leash dog walking at Ocean Beach and Crissy Field was harassing and disturbing snowy plovers and that this activity presented a serious threat to the GGNRA's overwintering snowy plover population, the GGNRA Superintendent implemented emergency restrictions requiring visitors to leash their dogs in the designated areas of Ocean Beach and Crissy Field during the 2006-2007 overwintering season and re-implemented on July 1, 2007, for the 2007-2008 overwintering season. The emergency restrictions provided as follows: • *Ocean Beach:* Dog-walking restricted to on-leash only at Ocean Beach, Stairwell 21 to Sloat Boulevard, including all tidelands. The definition of on-leash use requires that dogs must be restrained on a leash which shall not exceed six feet in length. • *Crissy Field:* Dog-walking restricted to on-leash only in the Crissy Field Wildlife Protection Area which encompasses: From the west, starting at Fort Point Mine Depot (a.k.a. Torpedo Wharf) eastward to concrete riprap, which lies approximately 700 feet east of former Coast Guard Station, and includes all uplands and all tidelands and extends from the high-water mark to 100 yards off shore. The emergency provisions would remain in effect until the end of the overwintering period, as determined through monitoring. The emergency provisions did not eliminate the opportunity for off-leash dog walking at Ocean Beach and Crissy Field outside of the designated Snowy Plover protection areas. At Crissy Field, dog walking options on the beach provide .99 miles of dog walking off-leash and .32 miles of dog walking on-leash, in addition to off-leash dog walking availability on the Crissy Field airfield and promenade. At Ocean Beach and the beach at Fort Funston, which lies just to the south of Ocean Beach, visitors have access to 2.4 miles of beach area for off-leash dog walking and 2.2 miles for on-leash dog walking. Need for Action The emergency regulatory provisions implemented by GGNRA in 2006 and 2007 are temporary. This rulemaking is needed to provide an interim solution developed with public participation for protecting the populations of Western Snowy Plovers that overwinter on Crissy Field and Ocean Beach until the negotiated rulemaking process is completed and a comprehensive special regulation for dog walking at GGNRA is adopted. This proposed regulation would require dogs to be on a leash, not exceeding six feet in length, within the land and water areas designated as the Crissy Field WPA and the Ocean Beach SPPA. These areas will be included in the Superintendent's Compendium and will be published through the posting of signs and the availability of maps on the park's official Web site and other places convenient to the public. This activity restriction will be in effect annually, July 1 through approximately May 1, or until monitoring determines that the species is no longer present. The proposed rule will only prohibit the activity of off-leash dog walking in these two areas, and the effects are offset by the availability of other areas nearby the Crissy Field WPA and the Ocean Beach SPPA for off-leash dog walking. Park visitors with dogs will still be allowed to use the Crissy Field WPA and the Ocean Beach SPPA provided that their dogs are leashed. This on-leash requirement will be a beneficial effect to visitors who come to this area to observe snowy plovers and a necessary measure for the protection and enhancement of the snowy plovers and their habitat. The proposed rule will not adversely affect GGNRA's natural, scenic, or cultural resources. In particular, the regulation will enhance GGNRA's ability to protect the Snowy Plover by decreasing the disturbances caused by dogs. Protection of threatened species is consistent with the 2006 Management Policies. Protection of threatened species is in keeping with the objectives of the Crissy Field Plan EA/FONSI, and the draft Snowy Plover Management Plan, which called for a leash requirement in the Snowy Plover Protection Area. Finally, the proposed rule is consistent with the general regulation at 36 CFR 2.15(a), which requires dogs to be on-leash in national park units. Compliance With Other Laws and Executive Orders Regulatory Planning and Review (Executive Order 12866) This document is not a significant rule and is not subject to review by the Office of Management and Budget under Executive Order 12866.
(1)This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities. Most of the areas proposed to be restricted through this rulemaking have been closed or restricted for the same activity through the park's compendium in the past, although those closures or restrictions were not published in the **Federal Register** . Since this is not a new closure or restriction, and because opportunities for off-leash dogwalking still exist in these areas, the proposed rule will not significantly affect the existing patterns of park users.
(2)This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. GGNRA has received letters of concurrence for the emergency restrictions in these areas, and has begun informal concurrence with U.S. Fish and Wildlife Service. This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.
(3)This rule does not raise novel legal or policy issues. Regulatory Flexibility Act The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). The economic effects of this rule are local in nature and negligible in scope. The primary purpose of this rule is to provide protection for a threatened species. The rule will require dogwalkers to leash their dogs when in specified areas. There will be no economic effect of this additional required action. Small Business Regulatory Enforcement Fairness Act (SBREFA) This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: a. Does not have an annual effect on the economy of $100 million or more. This rule will only affect those who choose to walk their dogs in two designated areas. b. Will not cause a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions. There will be no costs associated with the requirement to leash dogs in these two designated areas. c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. The primary purpose of this regulation is to provide additional protection for a threatened species and this rule will not change the ability of United States based enterprises to compete in any way. Unfunded Mandates Reform Act This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. The restrictions under this regulation would not have a significant effect or impose an unfunded mandate on any agency or on the private sector. This rule applies only to Federal parkland administered by the National Park Service in GGNRA, and no costs will be incurred by any parties. Takings (Executive Order 12630) In accordance with Executive Order 12630, the rule does not have significant takings implications. This rule does not apply to private property, or cause a compensable taking, there are no takings implications. Federalism (Executive Order 13132) In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. This regulation will not have a substantial direct effect on the states, or on the distribution of power and responsibilities among the various levels of government. The rule addresses dog walking in two areas of the Golden Gate National Recreation Area. The affected lands are under the administrative jurisdiction of the National Park Service. Civil Justice Reform (Executive Order 12988) In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. Paperwork Reduction Act This regulation does not require an information collection from 10 or more parties and a submission under the Paperwork Reduction Act is not required. An OMB form 83-I is not required. National Environmental Policy Act The Handbook for NPS Director's Order 12 contains a listing of Categorical Exclusions. Section 3.4 D(2) of the Director's Order 12 Handbook provides that “minor changes in programs and regulations pertaining to visitor activities” may be categorically excluded under NEPA. The proposed regulations for Ocean Beach and Crissy Field are actions that would result in minor changes to regulated visitor activities in these areas (transitioning seasonally from unleashed to leashed dog recreation). GGNRA has prepared all the appropriate Categorical Exclusion screening forms. These forms disclose that the adoption of these regulations would result in no measurable adverse environmental effects. Furthermore, no exceptional circumstances or conditions exist that would make use of a Categorical Exclusion inappropriate. As such, a Categorical Exclusion under NEPA is the appropriate form of NEPA compliance for these regulatory actions. Government-to-Government Relationship With Tribes In accordance with the President's memorandum of April 29, 1994, “Government to Government Relations with Native American Tribal Governments” (59 FR 22951) and 512 DM 2, we have evaluated potential effects on federally recognized Indian tribes and have determined that there are no potential effects. Clarity of Rule We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a)Be logically organized;
(b)Use the active voice to address readers directly;
(c)Use clear language rather than jargon;
(d)Be divided into short sections and sentences; and
(e)Use lists and tables wherever possible. If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc. *Drafting Information:* The primary authors of this proposed rule are Marybeth G. McFarland, Law Enforcement Specialist; Christine Powell, Public Affairs Specialist; Shirwin Smith, Management Assistant; GOGA; Barbara Goodyear, Solicitor, PWRO; Jerry Case, Regulations Program Manager; and Mike Tiernan, Solicitor, WASO. *Public Participation:* You may submit comments online at: *http://www.regulations.gov* . Follow the instructions for submitting comments. You may also mail or hand deliver comments to: Superintendent, Golden Gate National Recreation Area, Fort Mason, Building 201, San Francisco, California 94123, Attn: Snowy Plover Protection Rule. Public Availability of Comments Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. List of Subjects in 36 CFR Part 7 National Parks, Reporting and recordkeeping requirements. For the reasons stated in the preamble, the National Park Service proposes to amend 36 CFR part 7 as follows: PART 7—SPECIAL REGULATIONS, AREAS OF THE NATIONAL PARK SYSTEM 1. The authority for part 7 continues to read as follows: Authority: 16 U.S.C. 1, 3, 9a, 460(q), 462(k); Sec. 7.96 also issued under D.C. Code 8-137
(1981)and D.C. Code 40-721 (1981). 2. Add new paragraph
(d)to § 7.97 to read as follows: § 7.97 Golden Gate National Recreation Area
(d)*Dogs—Crissy Field and Ocean Beach Snowy Plover Areas*
(1)Dogs must be restrained on a leash not to exceed six feet in length during the Snowy Plover (Charadrius alexandrinus nivosus) overwintering season in the following areas:
(i)*Crissy Field Wildlife Protection Area (WPA):* Dogwalking restricted to on-leash only in the areas which encompass the shoreline and beach area north of the Crissy Field Promenade (excluding the paved parking area, sidewalks and grass lawn encompassing the Coast Guard Station complex) east of the Fort Point Mine Depot (a.k.a. Torpedo Wharf) to approximately 700 feet east of the former Coast Guard Station, and all tidelands and submerged lands to 100 yards offshore.
(ii)*Ocean Beach Snowy Plover Protection Area (SPPA):* Dog-walking restricted to on-leash only in the area which encompasses the shoreline and beach area west of the GGNRA boundary, between Stairwell 21 to Sloat Boulevard, including all tidelands and submerged lands to 1000 feet offshore.
(2)Notice of the overwintering season restrictions will be provided through the posting of signs at the site, on maps identifying the restricted areas on the park's official Web site and through maps made available at other places convenient to the public. This restriction will be in effect annually from July 1 until monitoring by the park determines that the species is no longer present. Dated: September 7, 2007. David M. Verhey, Acting Assistant Secretary for Fish and Wildlife and Parks. [FR Doc. E7-22654 Filed 11-19-07; 8:45 am] BILLING CODE 4312-FN-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 51 and 752 [EPA-HQ-OAR-2006-0605; FRL-8497-7] RIN 2060-AO24 Prevention of Significant Deterioration
(PSD)for Particulate Matter Less Than 2.5 Micrometers (PM <sup>2.5</sup> )—Increments, Significant Impact Levels
(SILs)and Significant Monitoring Concentration
(SMC)AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of extension of comment period. SUMMARY: The EPA is announcing an extension of the public comment period on our proposed amendments for the Prevention of Significant Deterioration
(PSD)for Particulate Matter Less Than 2.5 Micrometers (PM <sup>2.5</sup> )—Increments, Significant Impact Levels
(SILs)and Significant Monitoring Concentration
(SMC)(September 21, 2007). The EPA is extending the comment period that originally ends on November 20, 2007. The extended comment period will close on January 21, 2008. The EPA is extending the comment period because of the timely requests we received to do so. DATES: *Comments.* The comment period for the proposed rule published at 72 FR 54112, September 21, 2007, is extended. Comments must be received on or before January 21, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2006-0605, by one of the following methods: • *www.regulations.gov.* Follow the on-line instructions for submitting comments. • *E-mail: a-and-r-docket@epamail.epa.gov.* • *Fax:* 202-566-9744. • *Mail:* Attention Docket ID No. EPA-HQ-OAR-2006-0605, U.S. Environmental Protection Agency, EPA West (Air Docket), 1200 Pennsylvania Avenue, NW., Mailcode: 6102T, Washington, DC 20460. Please include a total of 2 copies. • *Hand Delivery:* U.S. Environmental Protection Agency, EPA West (Air Docket), 1301 Constitution Avenue, NW., Room 3334, Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2006-0605. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions.* Direct your comments to Docket ID No. EPA-HQ-OAR-2006-0605. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional instructions on submitting comments, go to the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the U.S. Environmental Protection Agency, Air Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Air Docket is
(202)566-1742. FOR FURTHER INFORMATION CONTACT: Raj Rao, Air Quality Policy Division (C504-03), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone
(919)541-5593, fax number
(919)541-5509; or electronic mail at *rao.raj@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI.* Do not submit this information to EPA through *www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Send or deliver information identified as CBI only to the following address: Roberto Morales, OAQPS Document Control Officer (C404-02), U.S. EPA, Research Triangle Park, NC 27711, Attention Docket ID No. EPA-HQ-OAR-2006-0605. 2. *Tips for Preparing Your Comments.* When submitting comments, remember to: • Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). • Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. • Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. B. Where Can I Get a Copy of This Document and Other Related Information? In addition to being available in the docket, an electronic copy of this proposal will also be available on the World Wide Web (WWW). Following signature by the EPA Administrator, a copy of this notice will be posted in the regulations and standards section of our NSR home page located at *http://www.epa.gov/nsr.* Dated: November 14, 2007. Robert J. Meyers, Principal Deputy Assistant Administrator, Office of Air and Radiation. [FR Doc. E7-22666 Filed 11-19-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2007-0638; FRL-8497-5] Revisions to the California State Implementation Plan; San Joaquin Valley Air Pollution Control District AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the San Joaquin Valley Air Pollution Control District (SJVAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound
(VOC)emissions from flare operations at facilities such as oil and chemical refineries. We are proposing to approve a local rule regulating these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action. DATES: Any comments must arrive by *December 20, 2007.* ADDRESSES: Submit comments, identified by docket number [DOCKET NUMBER], by one of the following methods: 1. *Federal eRulemaking Portal: www.regulations.gov.* Follow the on-line instructions. 2. *E-mail: steckel.andrew@epa.gov.* 3. *Mail or deliver:* Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. *Instructions:* All comments will be included in the public docket without change and may be made available online at *www.regulations.gov,* including any personal information provided, unless the comment includes Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through *www.regulations.gov* or e-mail. *www.regulations.gov* is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at *www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Jerald S. Wamsley, EPA Region IX, at either
(415)947-4111, or *wamsley.jerry@epa.gov.* SUPPLEMENTARY INFORMATION: Throughout this document, “We”, “Us”, and “Our” refer to the EPA. Table of Contents I. The State's Submittal A. What rule did the State submit? B. Are there other versions of this rule? C. What is the purpose of the submitted rule revisions? II. EPA's Evaluation and Action A. How is EPA evaluating the rule? B. Does the rule meet the evaluation criteria? C. EPA Recommendations To Further Improve the Rule D. Public Comment and Final Action I. The State's Submittal A. What rule did the State submit? Table 1 lists the rule addressed by this proposal with the date it was adopted by the local air agency and submitted by the California Air Resources Board (CARB). Table 1.—Submitted Rules Local agency Rule No. Rule title Adopted Submitted SJVAPCD 4311 Flares 06/15/06 12/29/06 On February 13, 2007, EPA found Rule 4311 met the completeness criteria in 40 CFR Part 51, Appendix V. SJVAPCD must meet these criteria before formal EPA review. B. Are there other versions of this rule? On February 26, 2003, EPA approved a version of Rule 4311 and incorporated it within the SIP; please see 68 FR 8835. California has not made any intervening submittals of the rule. C. What is the purpose of the submitted rule revisions? VOCs and oxides of nitrogen (NO <sup>X</sup> ) help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC and NO <sup>X</sup> emissions. SJVAPCD Rule 4311 is designed to decrease VOC and NO <sup>X</sup> emissions from industries such as refineries, unrecoverable gases from oil wells, vented gases from blast furnaces, unused gases from coke ovens, and gaseous wastes from chemical industries by requiring that flares be operated in a prescribed manner. The June 15, 2006 revisions to the rule set the applicability threshold for the rule at ten tons per year potential to emit VOC or NO <sup>X</sup> and provide a compliance schedule for facilities subject to the rule. EPA's technical support document
(TSD)has more information about the Rule 4311. II. EPA's Evaluation and Action A. How is EPA evaluating the rule? Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology
(RACT)for each category of sources covered by a Control Techniques Guidelines
(CTG)document as well as each major source in nonattainment areas (see section 182(a)(2)), and must not relax existing requirements (see sections 110(l) and 193). The SJVAPCD regulates an ozone nonattainment area (see 40 CFR part 81), so Rule 4311 must fulfill RACT. Guidance and policy documents that we used to help evaluate enforceability and RACT requirements consistently include the following: 1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987. 2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” USEPA, May 25, 1988 (the Bluebook). 3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” USEPA Region 9, August 21, 2001 (the Little Bluebook). B. Does the rule meet the evaluation criteria? We believe Rule 4311 is consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSD has more information on our evaluation. C. EPA Recommendations To Further Improve the Rule The TSD describes additional rule revisions that do not affect EPA's current action but are recommended for the next time the local agency modifies the rules. We recommend that SJVAPCD reconsider the utility of incorporating provisions such as those in South Coast Air Quality Management District Rule 1118 and Bay Area Air Quality Management District Rule 12-12 within Rule 4311 to aid their enforcing of the rule, developing an accurate emissions inventory for these sources, and minimizing excess emissions from flare activity to the maximum extent practicable. D. Public Comment and Final Action Because EPA believes Rule 4311 fulfills all relevant requirements, we are proposing to fully approve it as described in section 110(k)(3) of the Act. We will accept comments from the public on this proposal for the next 30 days. Unless we receive convincing new information during the comment period sufficient to cause us to reverse our position, we intend to publish a final approval action that will incorporate these rules into the federally enforceable SIP. III. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, *et seq.* ). Because this rule proposes to approve pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely proposes to approve a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed rule also is not subject to Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, *et seq.* ). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compound. Authority: 42 U.S.C. 7401, *et seq.* Dated: November 2, 2007. Laura Yoshii, Acting Regional Administrator, Region IX. [FR Doc. E7-22656 Filed 11-19-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2007-0621; FRL-8497-4] Revisions to the California State Implementation Plan, South Coast Air Quality Management District AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). These revisions concern particulate matter
(PM)emissions from fugitive dust sources and cement manufacturing plants. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action. DATES: Any comments must arrive by December 20, 2007. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2007-0621, by one of the following methods: 1. *Federal eRulemaking Portal:* *www.regulations.gov* . Follow the on-line instructions. 2. *E-mail:* *steckel.andrew@epa.gov* . 3. *Mail or deliver:* Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. *Instructions:* All comments will be included in the public docket without change and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through *www.regulations.gov* or e-mail. *www.regulations.gov* is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at *www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Jerry Wamsley, EPA Region IX, at either
(415)947-4111, or *wamsley.jerry@epa.gov* . SUPPLEMENTARY INFORMATION: Throughout this document, “we”, “us”, and “our” refer to EPA. Table of Contents I. The State's Submittal A. What rules did the State submit? B. Are there other versions of these rules? C. What is the purpose of the submitted rules? II. EPA's Evaluation and Action A. How is EPA evaluating the rules? B. Do the rules meet the evaluation criteria? C. EPA Recommendations To Further Improve the Rule D. Public Comment and Final Action III. Statutory and Executive Order Reviews I. The State's Submittal A. What rules did the State submit? Table 1 lists the rules we are proposing to approve with the dates that they were adopted by the SCAQMD and submitted by the California Air Resources Board. Table 1.—Submitted Rules Local agency Rule No. Rule title Adopted Submitted SCAQMD 403 Fugitive Dust 06/03/05 10/20/05 SCAQMD 1156 Further Reductions of Particulate Emissions from Cement Manufacturing Facilities 11/04/05 12/29/06 On November 22, 2005 and February 14, 2007, respectively, EPA found Rules 403 and 1156 met the completeness criteria in 40 CFR Part 51, Appendix V. The state must meet these criteria before formal EPA review can begin. B. Are there other versions of these rules? EPA has reviewed, approved, and incorporated into the SIP a prior version of Rule 403 (see 70 FR 69081, November 14, 2005). California has not submitted any subsequent versions of Rule 403. Regarding Rule 1156, California has not submitted a prior version for incorporation into the SIP. C. What is the purpose of the submitted rules? PM contributes to effects that are harmful to human health and the environment, including premature mortality, aggravation of respiratory and cardiovascular disease, decreased lung function, visibility impairment, and damage to vegetation and ecosystems. Section 110(a) of the CAA requires States to submit regulations that control PM emissions. SCAQMD Rule 403 is designed to limit the emissions of fugitive dust or PM from a variety of activities and sources such as construction sites, bulk material hauling, unpaved parking lots, and disturbed soil in open areas and vacant lots. The rule's provisions include a visible emissions property line standard, requirements to implement Best Available Control Measures (BACM), upwind/downwind PM10 concentration standards, prevention of material track-out onto paved public roads, and special control requirements for large operations (sources greater than 50 acres or with more than 5,000 cubic yards of daily earth-movement). The June 3, 2005 amendments to Rule 403 added BACMs for confined animal feed operations
(CAFO)to the rule and amended requirements for weed abatement activities. The new CAFO BACMs apply to manure and feedstock handling, disturbed surfaces, unpaved roads, and equipment parking areas (see the Staff Report Table 1, page 8). The amended requirements for weed abatement activities allow for discing weeds without applying water where the authorized agency determines that watering is not feasible and other effective control measures are used to minimize fugitive emissions and stabilize disturbed soils. Discing activities that meet these requirements are exempt from Rule 403. SCAQMD Rule 1156 is designed to limit PM from cement manufacturing facilities. Rule 1156 establishes requirements and control measures for the following:
(1)Visible emissions;
(2)material loading, unloading, and transferring;
(3)material crushing, screening, grinding, blending, drying, mixing, packaging, and other related operations;
(4)kilns and clinker coolers;
(5)material storage;
(6)air pollution control device performance standards;
(7)internal roadways and vehicle use areas; and,
(8)material track-out. The rule also has provisions for monitoring and determining compliance, recordkeeping, and exemptions from the rule. EPA's technical support documents
(TSD)have more information about these rules. II. EPA's Evaluation and Action A. How is EPA evaluating the rules? Generally, SIP rules must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193). In addition, SIP rules must implement Reasonably Available Control Measures (RACM), including Reasonably Available Control Technology (RACT), in moderate PM nonattainment areas, and Best Available Control Measures (BACM), including Best Available Control Technology (BACT), in serious PM nonattainment areas (see CAA sections 189(a)(1) and 189(b)(1)). The SCAQMD regulates a PM nonattainment area classified as serious (see 40 CFR part 81), so both of these rules must implement BACM/BACT. Guidance and policy documents that we use to help evaluate specific enforceability and RACM/RACT or BACM/BACT requirements consistently include the following: 1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987. 2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 **Federal Register** Notice,” (Blue Book), notice of availability published in the May 25, 1988 **Federal Register** . 3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook). 4. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992). 5. “State Implementation Plans for Serious PM-10 Nonattainment Areas, and Attainment Date Waivers for PM-10 Nonattainment Areas Generally; Addendum to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 59 FR 41998 (August 16, 1994). 6. “PM-10 Guideline Document,” EPA 452/R-93-008, April 1993. 7. “Fugitive Dust Background Document and Technical Information Document for Best Available Control Measures,” EPA 450/2-92-004, September 1992. B. Do the rules meet the evaluation criteria? We believe these rules are consistent with the relevant policy and guidance regarding enforceability, BACM, and SIP relaxations. Each rule is discussed below. Under Rule 403, the weed abatement amendments provide added control measures for weed abatement activities that are allowed an exemption because it is infeasible to water prior to discing or mowing. Those weed abatement operations that do not use water are subject to disturbed open area stabilization requirements and the rule's fence-line opacity requirement. Also, any added PM emissions that may occur as a result of the exemptions are offset within the SIP by the reduced PM emissions generated by the new CAFO requirements. Consequently, we find that the revisions to Rule 403 do not relax the SIP or interfere with any applicable requirements of the Act. Rule 1156 is a new rule that strengthens the SIP by requiring additional BACM and MSMs for cement manufacturing facilities. As such, it will not interfere with any applicable requirements concerning attainment and reasonable further progress, or any other applicable requirements of the Act. Therefore, approval of this rule is consistent with CAA 110(l). Because this rule does not modify any control requirements in effect prior to November 15, 1990, section 193 of the Act does not apply to our action. The TSD has more information on our evaluation of these rules. C. EPA Recommendations To Further Improve the Rule The TSD for Rule 403 describes additional rule revisions that do not affect EPA's current action but are recommended for the next time the SCAQMD modifies the rule. D. Public Comment and Final Action Because EPA believes the submitted rules fulfill all relevant requirements, we are proposing to fully approve them as described in section 110(k)(3) of the Act. We will accept comments from the public on this proposal for the next 30 days. Unless we receive convincing new information during the comment period that causes us to reconsider this proposed approval action, we intend to publish a final approval action that will incorporate these rules into the federally enforceable SIP. III. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601, *et seq.* ). Because this rule proposes to approve pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely proposes to approve a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, *et seq.* ). List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements. Dated: November 2, 2007. Laura Yoshii, Acting Regional Administrator, Region IX. [FR Doc. E7-22658 Filed 11-19-07; 8:45 am] BILLING CODE 6560-50-P 72 223 Tuesday, November 20, 2007 Notices AGENCY FOR INTERNATIONAL DEVELOPMENT Senior Executive Service Performance Review Board; Update AGENCY: U.S. Agency for International Development, Office of Inspector General. ACTION: Notice. Senior Executive Services
(SES)Performance Review Board: Update. SUMMARY: This notice is hereby given of the appointment of members of the updated USAID OIG SES Performance Review Board. DATES: November 15, 2007. FOR FURTHER INFORMATION CONTACT: Paula F. Hayes, Assistant Inspector General for Management, Office of Inspector General, U.S. Agency for International Development, 1300 Pennsylvania Avenue, NW., Room 8.08-029, Washington, DC 20523-8700; telephone 202-712-0010; Fax 202-216-3392; Internet e-mail address: *phayes@usaid.gov* (for e-mail messages, the subject line should include the following reference—USAID OIG SES Performance Review Board). SUPPLEMENTARY INFORMATION: 5 U.S.C. 4314(b)(c) requires each agency to establish, in accordance with regulations prescribed by the office of Personnel Management at 5 CFR part 430, subpart C and Section 430.307 thereof in particular, one or more Senior Executive Service Performance Review Boards. The board shall review and evaluate the initial appraisal of each USAID OIG senior executive's performance by his or her supervisor, along with any recommendations to the appointing authority relative to the performance of the senior executive. This notice updates the membership of the USAID OIG's SES Performance Review Board as it was last published on May 31, 2007. *Approved:* November 15, 2007. The following have been selected as regular members of the SES Performance Review Board of the U.S. Agency for International Development, Office of Inspector General: Michael G. Carroll, Deputy Inspector General. Adrienne Rish, Assistant Inspector General for Investigations. Paula F. Hayes, Assistant Inspector General for Management. Lisa S. Goldfluss, Legal Counsel. Alvin A. Brown, Deputy Assistant Inspector General for Audit. Howard I. Hendershot, Deputy Assistant Inspector General for Investigations. Winona Varnon, Director, Security Services, Department of Education. Pauline K. Brunelli, Director, Federal Voting Assistance Program Department of Defense. Aletha Brown, Inspector General, Equal Employment Opportunity Commission. Mark Bialek, Counsel to the Inspector General, Environmental Protection Agency. Theodore P. Alves, Assistant Inspector General Financial Information, Department of Transportation. Dated: November 15, 2007. Donald A. Gambatesa, Inspector General. [FR Doc. 07-5771 Filed 11-19-07; 8:45 am]
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Traces to 53 documents
U.S. Code
- Rates and charges; schedules; suspension of new rates; automatic adjustment clauses§ 824d
- Complaints§ 825e
- Definitions§ 601
- Definitions§ 632
- SHORT TITLE.§ 9701
- Mode of recovery§ 2461
- Definitions and application§ 3701
- Federal Energy Regulatory Commission§ 60502
- Definitions§ 802
- Importation of controlled substances§ 952
- Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals§ 971
- Penalties for simple possession§ 844
- Short title§ 301
- Removal of exemption of certain drugs§ 814
- Authority and criteria for classification of substances§ 811
- Short title§ 201
- Unfair competition and unlawful practices§ 205
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Departmental regulations§ 301
- Imposition of tax§ 4181
- Avoidance of duplicative or unnecessary analyses§ 605
- Establishment, functions, and activities§ 272
- Transferred§ 1226
- Transferred§ 191
- Repealed. Pub. L. 113–287, § 7, Dec. 19, 2014, 128 Stat. 3272§ 1
- Repealed. Pub. L. 113–287, § 7, Dec. 19, 2014, 128 Stat. 3272§ 3
- Repealed. Pub. L. 113–287, § 7, Dec. 19, 2014, 128 Stat. 3272§ 1a–1
- Repealed. Pub. L. 113–287, § 7, Dec. 19, 2014, 128 Stat. 3272§ 1a–2
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Purposes§ 3501
- Congressional findings and declaration of purpose§ 7401
- Ratings for performance appraisals§ 4314
CFR
- Projects or actions categorically excluded.§ 380.4
- What size standards has SBA identified by North American Industry Classification System codes?§ 121.201
- Maintenance of records.§ 1310.04
- Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.§ 1310.10
- Appellations of origin.§ 4.25
- Prohibited practices.§ 4.39
- Delegations of the Administrator.§ 9.3
- Brand names.§ 4.33
- Rules and regulations.§ 70.701
- Submission of AVA petitions.§ 9.11
- Safety Zones; Fireworks Displays, Air Shows and Swim Events in the Captain of the Port Long Island Sound Zone.§ 165.151
- Delegation of rulemaking authority.§ 1.05-1
- Closures and public use limits.§ 1.5
- Applicability and scope.§ 1.2
- Pets.§ 2.15
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39 references not yet in our index
- 18 CFR 141.61
- 225 F.3d 667
- 535 U.S. 1
- 5 CFR 1320.11
- 18 CFR 380
- 5 USC 601-12
- 18 CFR 141
- 18 CFR 385
- 15 USC 79
- 16 USC 791a-828c
- 42 USC 7101-7352
- 5 USC 551-557
- 15 USC 717-717z
- 16 USC 791a-825v
- 21 CFR 1310
- 21 USC 801-971
- Pub. L. 109-177
- Pub. L. 100-690
- Pub. L. 103-200
- Pub. L. 104-237
- Pub. L. 106-310
- 5 USC 601-612
- 27 CFR 4
- 27 CFR 9
- 27 CFR 70
- 33 CFR 165
- Pub. L. 104-121
- 44 USC 3501-3520
- 2 USC 1531-1538
- 42 USC 4321-4370f
- Pub. L. 107-295
- 36 CFR 7
- Pub. L. 92-589
- 40 CFR 2
- 40 CFR 52
- 40 CFR 51
- 40 CFR 81
- Pub. L. 104-4
- 5 CFR 430
Citation graph
cites case law
Notices
Notice of proposed rulemaking
F. App'x225 F.3d 667
SCOTUS535 U.S. 1
Cite18 CFR 141.61
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