        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 82
        [EPA-HQ-OAR-2007-0297; FRL-8325-7]
        RIN A2060-AO44
        Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2008

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          EPA is proposing to allocate essential use allowances for import and production of Class I ozone-depleting substances (ODSs) for calendar year 2008. Essential use allowances enable a person to obtain controlled Class I ODSs as part of an exemption to the regulatory ban on the production and import of these chemicals, which became effective as of January 1, 1996. EPA allocates essential use allowances for exempted production or import of a specific quantity of Class I substances solely for the designated essential purpose. The proposed allocations total 27.0 metric tons (MT) of chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for 2008.

          DATES:

          Written comments on this proposed rule must be received by the EPA Docket on or before July 12, 2007, unless a public hearing is requested. Comments must then be received on or before 30 days following the public hearing. Any party requesting a public hearing must notify the contact listed below under FOR FURTHER INFORMATION CONTACT by 5 p.m. Eastern Standard Time on June 18, 2007. If a hearing is held, it will take place on June 27, 2007 at EPA headquarters in Washington DC. EPA will post a notice on our Web site (http://www.epa.gov/ozone) announcing further information on the hearing if it is requested.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2007-0297, by one of the following methods:
          • www.regulations.gov: Follow the on-line instructions for submitting comments.
          • E-mail: A-and-R-docket@epa.gov.
          • Fax: 202-566-9744.

          • Mail: Air Docket, Environmental Protection Agency, Mailcode 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
          • Hand Delivery or Courier. Deliver your comments to: EPA Air Docket, EPA West 1301 Constitution Avenue, NW., Room 3334, Mail Code 2822T, Washington, DC 20460. 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-2007-0297. EPA's policy is that all comments received by the docket 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 through www.regulations.gov or e-mail that you consider to be CBI or otherwise protected. If you would like the Agency to consider comments that include CBI, EPA recommends that you submit the comments to the docket that exclude the CBI portion but that you provide a complete version of your comments, including the CBI, to the person listed under ADDRESSES above. The www.regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

            Docket: All documents in the docket are listed in the 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 Air Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. This Docket Facility 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:

          Kirsten M. Cappel, by regular mail: U.S. Environmental Protection Agency, Stratospheric Protection Division (6205J), 1200 Pennsylvania Avenue, NW., Washington, DC, 20460; by courier service or overnight express: 1301 L Street, NW., Room 1047C, Washington DC, 20005; by telephone: (202) 343-9556; or by e-mail: cappel.kirsten@epa.gov.

        SUPPLEMENTARY INFORMATION:

          Table of Contents
          I. General Information
          What should I consider when preparing my comments?
          II. Basis for Allocating Essential Use Allowances
          A. What are essential use allowances?
          B. Under what authority does EPA allocate essential use allowances?
          C. What is the process for allocating essential use allowances?
          III. Essential Use Allowances for Medical Devices
          IV. Proposed Allocation of Essential Use Allowances for Calendar Year 2008
          V. Statutory and Executive Order Reviews
          A. Executive Order 12866: Regulatory Planning and Review
          B. Paperwork Reduction Act
          C. Regulatory Flexibility Act
          D. Unfunded Mandates Reform Act
          E. Executive Order 13132: Federalism
          F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
          G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
          H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use
          I. National Technology Transfer and Advancement Act

        I. General Information
        What should I consider when preparing my comments?
        1. Confidential Business Information. 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.
        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.
        II. Basis for Allocating Essential Use Allowances
        A. What are essential use allowances?
        Essential use allowances are allowances to produce or import certain ODSs in the U.S. for purposes that have been deemed “essential” by the U.S. Government and by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol).
        The Montreal Protocol is the international agreement aimed at reducing and eliminating the production and consumption 1

           of ODSs. The elimination of production and consumption of Class I ODSs is accomplished through adherence to phaseout schedules for specific Class I ODSs,2
           which include CFCs, halons, carbon tetrachloride, and methyl chloroform. As of January 1, 1996, production and import of most Class I ODSs were phased out in developed countries, including the United States.

            1 “Consumption” is defined as the amount of a substance produced in the United States, plus the amount imported into the United States, minus the amount exported to Parties to the Montreal Protocol (see Section 601(6) of the Clean Air Act).

            2 Class I ozone depleting substances are listed at 40 CFR part 82, subpart A, appendix A.

        However, the Montreal Protocol and the Clean Air Act (the Act) provide exemptions that allow for the continued import and/or production of Class I ODSs for specific uses. Under the Montreal Protocol, exemptions may be granted for uses that are determined by the Parties to be “essential.” Decision IV/25, taken by the Parties to the Protocol in 1992, established criteria for determining whether a specific use should be approved as essential, and set forth the international process for making determinations of essentiality. The criteria for an essential use, as set forth in paragraph 1 of Decision IV/25, are the following:
        “(a) That a use of a controlled substance should qualify as 'essential' only if:
        (i) It is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects); and
        (ii) There are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;
        (b) That production and consumption, if any, of a controlled substance for essential uses should be permitted only if:
        (i) All economically feasible steps have been taken to minimize the essential use and any associated emission of the controlled substance; and
        (ii) The controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, also bearing in mind the developing countries' need for controlled substances.”
        B. Under what authority does EPA allocate essential use allowances?
        Title VI of the Act implements the Montreal Protocol for the United States.3
           Section 604(d) of the Act authorizes EPA to allow the production of limited quantities of Class I ODSs after the phaseout date for the following essential uses:

            3 See Section 614(b) of the Act. EPA's regulations implementing the essential use provisions of the Act and the Protocol are located in 40 CFR part 82.

        (1) Methyl Chloroform, “solely for use in essential applications (such as nondestructive testing for metal fatigue and corrosion of existing airplane engines and airplane parts susceptible to metal fatigue) for which no safe and effective substitute is available.” Under section 604(d)(1) of the Act, this exemption was available only until January 1, 2005. Prior to that date, EPA issued methyl chloroform allowances to the U.S. Space Shuttle and Titan Rocket programs.
        (2) Medical devices (as defined in section 601(8) of the Act), “if such authorization is determined by the Commissioner [of the Food and Drug Administration], in consultation with the Administrator [of EPA] to be necessary for use in medical devices.” EPA issues allowances to manufacturers of MDIs that use CFCs as propellant for the treatment of asthma and chronic obstructive pulmonary disease.
        (3) Aviation safety, for which limited quantities of halon-1211, halon-1301, and halon-2402 may be produced “if the Administrator of the Federal Aviation Administration, in consultation with the Administrator [of EPA] determines that no safe and effective substitute has been developed and that such authorization is necessary for aviation safety purposes.” Neither EPA nor the Parties have ever granted a request for essential use allowances for halon, because alternatives are available or because existing quantities of this substance are large enough to provide for any needs for which alternatives have not yet been developed.

        An additional essential use exemption under the Montreal Protocol, as agreed in Decision X/19, is the general exemption for laboratory and analytical uses. This exemption is reflected in EPA's regulations at 40 CFR part 82, subpart A. While the Act does not specifically provide for this exemption, EPA has determined that an exemption for essential laboratory and analytical uses is allowable under the Act as a de minimis exemption. The de minimis exemption is addressed in EPA's final rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol subsequently agreed (Decision XI/15) that the general exemption does not apply to the following uses: Testing of oil and grease, and total petroleum hydrocarbons in water; testing of tar in road-paving materials; and forensic finger-printing. EPA incorporated this exemption at Appendix G to Subpart A of 40 CFR part 82 on February 11, 2002 (67 FR 6352). In a December 29, 2005 final rule, EPA extended the general exemption for laboratory and analytical uses through December 31, 2007 (70 FR 77048), in accordance with Decision XV/8 of the Parties to the Protocol. EPA plans to update this exemption in accordance with future Decisions from the Parties and its own regulations.
        C. What is the process for allocating essential use allowances?
        The procedure set out by Decision IV/25 calls for individual Parties to nominate essential uses and the total amount of ODSs needed for those essential uses on an annual basis. The Protocol's Technology and Economic Assessment Panel (TEAP) evaluates the nominated essential uses and makes recommendations to the Parties. The Parties make the final decisions on whether to approve a Party's essential use nomination at their annual meeting. This nomination process occurs approximately two years before the year in which the allowances would be in effect. The allowances proposed for allocation for 2008 were first nominated by the United States in January 2006.
        For MDIs, EPA requests information from manufacturers about the number and type of MDIs they plan to produce, as well as the amount of CFCs necessary for production. EPA then forwards the information to the Food and Drug Administration (FDA), which determines the amount of CFCs necessary for MDIs in the coming calendar year. Based on FDA's determination, EPA proposes allocations to each eligible entity. Under the Act and the Montreal Protocol, EPA may allocate essential use allowances in quantities that together are below or equal to the total amount approved by the Parties. EPA will not allocate essential use allowances in amounts higher than the total approved by the Parties. For 2008, the Parties authorized the United States to allocate up to 385 MT of CFCs for essential uses. In the 2008 nomination for essential use allowances, the United States did not request CFCs for use in MDIs where the sole active ingredient is albuterol.
        III. Essential Use Allowances for Medical Devices
        The following is a step-by-step list of actions EPA and FDA have taken thus far to implement the exemption for medical devices found at section 604(d)(2) of the Act for the 2008 calendar year.
        1. On January 17, 2007, EPA sent letters to MDI manufacturers requesting the following information under section 114 of the Act (“114 letters”):
        a. The MDI product where CFCs will be used.

        b. The number of units of each MDI product produced from 1/1/06 to 12/31/06.

        c. The number of units anticipated to be produced in 2007.
        d. The number of units anticipated to be produced in 2008.
        e. The gross target fill weight per unit (grams).
        f. Total amount of CFCs to be contained in the MDI product for 2008.
        g. The additional amount of CFCs necessary for production.
        h. The total CFC request per MDI product for 2008.

        The 114 letters are available for review in the Air Docket ID No. EPA-HQ-OAR-2007-0297. The companies requested that their responses be treated as confidential business information; for this reason, EPA has placed the responses in the confidential portion of the docket.
        2. At the end of January 2007, as required by 40 CFR 82.13(u), EPA received information from MDI manufacturers that included such data as the type and quantity of CFCs held at the end of the year (i.e. stocks of pre-1996 and post-1996 CFCs). The data submitted in reports from each MDI manufacturer is available for review in the Air Docket ID No. EPA-HQ-OAR-2007-0297. The companies requested that their responses be treated as confidential business information; for this reason, EPA has placed the individual responses in the confidential portion of the docket.
        3. On February 28, 2007, EPA sent FDA the information MDI manufacturers provided in response to the 114 letters and information required by 40 CFR 82.13(u) with a letter requesting that FDA make a determination regarding the amount of CFCs necessary for MDIs for calendar year 2008. This letter is available for review in Air Docket ID No. EPA-HQ-OAR-2007-0297.
        4. On May 1, 2007 FDA sent a letter to EPA stating the amount of CFCs determined by the Commissioner to be necessary for each MDI company in 2008. This letter is available for review in the Air Docket ID No. EPA-HQ-OAR-2007-0297. FDA's letter informed EPA that it had determined that 27.0 MT of CFCs were medically necessary for use in MDIs in 2008. The letter stated: “Our determination for the allocation of CFCs is lower than the total amount requested by sponsors. In reaching this estimate, we took into account the sponsors' production of MDIs that used CFCs as propellant in 2006, their estimated production in 2007, their estimated production in 2008, their anticipated essential-use allocations in 2007, and their current (as of December 31, 2006) stockpile levels. Our determination took into account any transferred CFCs as well as pre-1996 CFC amounts. We also considered the different types and blends of CFCs necessary to produce specific MDIs. Finally, we based our determination for 2008 on an estimate of the quantity of CFCs that would allow manufacturers to have a 12-month stockpile at the end of 2008 in accordance with paragraph 3 of Decision XVI/12 and paragraph 2 of Decision XVII/5.”
        The letter stated that in making its determination, FDA made the following assumptions:
        • All manufacturers will receive the full essential-use allocation proposed by EPA for calendar year 2007 (71 FR 64668, November 3, 2006);
        • All manufacturers will procure the full quantity of CFCs allocated to them for calendar year 2007;
        • The number of albuterol CFC MDIs produced in 2008 will be no more than half of the number produced in 2007, with albuterol HFA MDIs making up the remainder; and
        • No bulk CFC currently held by, or allocated to, any manufacturer will be exported from the United States.
        FDA's determination specified that the essential use allowances allocated for 2008 should only be used to acquire CFC-114 for the production of epinephrine MDIs. FDA's letter stated: “In recent years, we aggregated the amounts for CFC-11, -12, and -114 and provided recommendations on the total amounts necessary to protect the public health. This year, as sponsors transition to non-CFC alternative and require smaller amounts of CFCs to produce CFC MDIs, we considered individual amounts of CFCs necessary to protect the public health and recommend an allocation of 27.0 tonnes of CFC-114 to Armstrong for the manufacture of epinephrine CFC MDIs.” Consistent with FDA's determination letter, EPA is proposing to allocate 27.0 MT of CFC-114 to Armstrong for the production of epinephrine MDIs for 2008.
        EPA has confirmed with FDA that this determination is consistent with Decision XVII/5, including language on stocks that states that Parties “shall take into account pre- and post-1996 stocks of controlled substances as described in paragraph 1(b) of Decision IV/25, such that no more than a one-year operational supply is maintained by that manufacturer.” In its analysis of a one-year operational supply of CFCs for the production of CFC-albuterol MDIs, FDA informed EPA that it calculates volumes to allow the manufacturer to end the calendar year with the appropriate stock of CFCs for essential uses. Allowing manufacturers to maintain up to a one-year operational supply accounts for unexpected variability in the demand for MDI products or other unexpected occurrences in the market and therefore ensures that MDI manufacturers are able to produce their essential use MDIs.
        In accordance with the FDA determination, today's action proposes to allocate essential use allowances to Armstrong for a total of 27.0 MT of CFC-114 for the production of epinephrine MDIs only for calendar year 2008.
        The amounts listed in this proposal are subject to additional review, and revision, by EPA and FDA if information demonstrates that the proposed allocations are either too high or too low. We specifically request comment on the extent to which the proposed allocation of CFCs is sufficient to protect public health and ensure the manufacture and continuous availability of CFCs necessary to meet the expected demand. We also request comment on whether the proposed allocation, when considered along with current stocks, will best protect consumers by providing a smooth transition to non-CFC alternatives. Commenters requesting increases or decreases of essential use allowances should provide detailed information supporting a claim for additional or fewer CFCs. Any company that needs less than the full amount listed in this proposal should notify EPA of the actual amount needed.
        IV. Proposed Allocation of Essential Use Allowances for Calendar Year 2008

          Table I.—Essential Use Allowances for Calendar Year 2008

            Company
            Chemical
            2008 Quantity (metric tons)

              (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease

            Armstrong Pharmaceuticals
            CFC-114 (production of epinephrine MDIs only)
            27.0

        EPA proposes to allocate essential use allowances for calendar year 2008 to the entity listed in Table I. These allowances are for the production or import of the specified quantity of Class I controlled substances solely for the specified essential use.
        V. Statutory and Executive Order Reviews
        A. Executive Order 12866: Regulatory Planning and Review
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it raises novel legal or policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.
        EPA prepared an analysis of the potential costs and benefits related to this action. This analysis is contained in the Agency's Regulatory Impact Analysis (RIA) for the entire Title VI phaseout program (U.S. Environmental Protection Agency, “Regulatory Impact Analysis: Compliance with Section 604 of the Clean Air Act for the Phaseout of Ozone Depleting Chemicals,” July 1992). A copy of the analysis is available in the docket for this action and the analysis is briefly summarized here. The RIA examined the projected economic costs of a complete phaseout of consumption of ozone-depleting substances, as well as the projected benefits of phased reductions in total emissions of CFCs and other ozone-depleting substances, including essential use CFCs used for MDIs.
        B. Paperwork Reduction Act

        This action does not impose any new information collection burden. The recordkeeping and reporting requirements included in this action are already included in an existing information collection burden and this action does not propose any changes that would affect the burden. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations at 40 CFR 82.8(a) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0170, EPA ICR number 1432.25. A copy of the OMB approved Information Collection Request (ICR) may be obtained from Susan Auby, Collection Strategies Division; U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by calling (202) 566-1672.
        Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
        An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
        C. Regulatory Flexibility Act
        The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
        For purposes of assessing the impact of today's proposed rule on small entities, small entity is defined as: (1) Pharmaceutical preparations manufacturing businesses (NAICS code 325412) that have less than 750 employees; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant its field.
        After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.
        This action, once finalized, will provide an otherwise unavailable benefit to those companies that are receiving essential use allowances by creating an exemption to the regulatory phaseout of chlorofluorocarbons. We have therefore concluded that today's proposed rule will relieve regulatory burden for all small entities. We continue to be interested in the potential impact of the proposed rule on small entities and welcome comments on issues related to such impacts.
        D. Unfunded Mandates Reform Act
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year.
        Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative, if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

        Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed a small government agency plan under section 203 of the UMRA. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
        Today's proposed rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector, since it merely provides exemptions from the 1996 phaseout of Class I ODSs. Similarly, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments, because this rule merely allocates essential use exemptions to entities as an exemption to the ban on production and import of Class I ODSs.
        E. Executive Order 13132: Federalism
        Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
        This proposed rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.
        F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
        Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This proposed rule does not have tribal implications, as specified in Executive Order 13175. Today's proposed rule affects only the companies that requested essential use allowances. Thus, Executive Order 13175 does not apply to this rule.
        G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
        Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.
        EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such as the analysis required under section 5-501 of the Order has the potential to influence the regulation. This proposed rule is not subject to Executive Order 13045 because it implements Section 604(d)(2) of the Clean Air Act which states that the Agency shall authorize essential use exemptions should the Food and Drug Administration determine that such exemptions are necessary.
        H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use
        This proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The rule affects only the pharmaceutical companies that requested essential use allowances.
        I. National Technology Transfer and Advancement Act

        Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rule does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.
        J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
        Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
        EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because any change in the level of environmental protection for any affected populations will not have any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. Any impacts of this proposed rule will be equally distributed among all populations.

          List of Subjects in 40 CFR Part 82
          Environmental protection, Administrative practice and procedure, Air pollution control, Chemicals, Imports, Ozone, Reporting and recordkeeping requirements.

          Dated: June 6, 2007.
          Stephen L. Johnson,
          Administrator.

        40 CFR part 82 is proposed to be amended as follows:

          PART 82—PROTECTION OF STRATOSPHERIC OZONE
          1. The authority citation for part 82 continues to read as follows:

            Authority:
            42 U.S.C. 7414, 7601,7671-7671q.

            Subpart A—Production and Consumption Controls

          2. Section 82.8 is amended by revising the table in paragraph (a) to read as follows:

            § 82.8
            Grant of essential use allowances and critical use allowances.
            (a) * * *

              Table I.—Essential Use Allowances for Calendar Year 2008

                Company
                Chemical
                2008 Quantity (metric tons)

                  (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease

                Armstrong Pharmaceuticals
                CFC-114 (production of epinephrine MDIs only)
                27.0

      [FR Doc. E7-11299 Filed 6-11-07; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Health Care Financing Administration
        42 CFR Part 413
        [HCFA-1143-P]
        RIN 0938-AK25
        Medicare Program; Prospective Payment System for Hospital Outpatient Services: Revision of the Provider-Based Location Criteria for Certain PPS-Exempt Facilities

          AGENCY:
          Health Care Financing Administration (HCFA), HHS

          ACTION:
          Proposed rule.

          SUMMARY:
          This proposed rule would revise the criteria related to provider-based status requirements for hospitals excluded from the hospital inpatient prospective payment system (PPS) under section 4417 of the Balanced Budget Act of 1997 (BBA). We are proposing to require that satellites of a hospital that qualifies for a PPS exclusion under section 4417 of BBA must be located within the same Metropolitan Statistical Area as the hospital, instead of requiring that these satellites meet the existing requirement of location within the immediate vicinity of the hospital. The satellites of these excluded hospitals would still be required to comply with the other provider-based status criteria.

          DATES:

          We will consider comments if we receive them at the appropriate address, as provided below, no later than 5 p.m. on October 2, 2000.

          ADDRESSES:
          Mail written comments (1 original and 3 copies) to the following address: Health Care Financing Administration, Department of Health and Human Services, Attention: HCFA-1143-P, P.O. Box 8013, Baltimore, MD 21244-8013.
          To ensure that mailed comments are received in time for us to consider them, please allow for possible delays in delivering them.
          If you prefer, you may deliver your written comments (1 original and 3 copies) to one of the following addresses: Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or Room C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-8013.
          Comments mailed to the above addresses may be delayed and received too late to be considered.
          Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code HCFA-1143-P. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 445-G of the Department's office at 200 Independence Avenue, SW., Washington, DC, on Monday through Friday of each week from 8:30 to 5 p.m. (phone: (202) 690-7890).

          FOR FURTHER INFORMATION CONTACT:
          Miechal Lefkowitz, (410) 786-5316.

        SUPPLEMENTARY INFORMATION:
        I. Background
        A. Provider-Based Status
        On April 7, 2000, we published a final rule specifying the criteria that must be met for a determination regarding provider-based status (65 FR 18504). Since the beginning of the Medicare program, some providers, which we refer to as “main providers,” have owned and operated other facilities that were administered by the main provider. The subordinate facilities may or may not be located on the main provider's campus. To accommodate for the financial integration of the two facilities without creating an administrative burden, we have permitted the subordinate facility to be considered a provider-based facility. Furthermore, a portion of the costs incurred by the main provider may be allocated to a provider-based facility. This allocation can result in additional Medicare payments to the provider-based facility.
        The regulations at § 413.65, effective October 10, 2000, define provider-based status as, “the relationship between a main provider and a provider-based entity or a department of a provider, remote location of a hospital, or satellite facility, that complies with the provisions of this section.” Before a main provider may bill for services of a facility as if the facility were provider-based, or before it includes costs of those services on its cost report, the facility must meet the criteria listed in the regulations at § 413.65(d). Among these criteria are the requirements that the main provider and the facility must have common licensure (when appropriate), the facility must operate under the ownership and control of the main provider, and the facility must be located in the immediate vicinity of the main provider.
        B. Satellite Facilities
        A satellite facility is defined at § 412.22(h)(1) as, “a part of a hospital that provides inpatient services in a building also used by another hospital, or in one or more entire buildings located on the same campus as buildings used by another hospital.” A satellite facility is a type of facility that may be considered provider-based if it meets the criteria under § 413.65(d). In some cases, a hospital may have several satellite locations.
        C. Long Term Care Hospitals and Satellite Facilities
        Satellite facilities are common among long term care hospitals (LTHs). A LTH, as defined under section 1886(d) of the Social Security Act (the Act), is a hospital with an average length of stay of greater than 25 days. These hospitals are excluded from the prospective payment system (PPS) and are paid on a reasonable cost basis subject to a per-discharge cost limit for inpatient hospital services. A LTH that has a satellite facility must comply with the regulations at § 412.22(h)(2). Section 412.22(h)(2)(i) requires that if the hospital (other than a children's hospital) was excluded from the PPS for the most recent cost reporting period beginning before October 1, 1997, the hospital's number of State-licensed and Medicare-certified beds, including those at the satellite facilities, must not exceed the hospital's number of State-licensed and Medicare-certified beds on the last day of the hospital's last cost reporting period beginning before October 1, 1997.
        D. Exception for Certain LTHs
        Although section 1886(d) of the Act defines a LTH as a hospital with an average length of stay of greater than 25 days, under section 4417 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), as implemented in the regulations at § 412.23(e)(2), the Congress extended the LTH exclusion to any hospital that first received payment under section 1886(d)(1)(B)(iv) of the Act in 1986, has an average length of stay of greater than 20 days, and had 80 percent or more of its annual Medicare inpatient discharges with a principal diagnosis of neoplastic disease in the 12-month cost reporting period ending in fiscal year 1997. On July 30, 1999, we published a final rule (64 FR 41490) at § 412.22(h)(2) specifying the criteria that a PPS exempt hospital with a remote inpatient satellite facility located within a PPS hospital must meet to qualify for payment as a PPS exempt hospital for services furnished at that satellite. We also stated in that final rule that, in view of the special status accorded to hospitals that qualify for LTH status under section 4417 of the BBA, we believed those hospitals should also be exempt from the requirements at § 412.22(h)(2), which are applicable to satellite facilities of PPS-excluded hospitals. Accordingly, at § 412.22(h)(3)(ii), we specified that the criteria at § 412.22(h)(2) do not apply to a hospital excluded from the PPS under § 412.23(e)(2).
        II. Provisions of This Proposed Rule

        Since the publication of the provider-based regulations on April 7, 2000, it has come to our attention that hospitals that qualify as LTHs under section 4417 of the BBA could be precluded from having a satellite facility under the revised provider-based regulations. Although those hospitals' satellites might meet all other criteria under § 413.65(d) for achieving provider-based status, they might not meet the requirement at § 413.65(d)(7) of being located in the immediate vicinity of the main provider. Under § 413.65(d)(7), to meet the provider-based criteria, the main provider must show that the satellite is located within its immediate vicinity by demonstrating that, either (A) at least 75 percent of the patients served by the satellite reside in the same zip code areas as at least 75 percent of the patients served by the main provider; or (B) at least 75 percent of the patients served by the facility or organization that required the type of care furnished by the main provider received that care from that provider (for example, at least 75 percent of the patients of a rural health clinic (RHC) seeking provider-based status received inpatient hospital services from the hospital that is the main provider); or (C) if the facility or organization is unable to meet the criteria in § 413.65(d)(7)(i)(A) or § 413.65(d)(7)(i)(B) of this section because it was not in operation during all of the 12-month period described in the previous sentence, the facility or organization must be located in a zip code area included among those that, during all of the 12-month period described in the previous sentence, accounted for at least 75 percent of the patients served by the main provider.
        In view of this concern, and in consideration of the special status accorded to hospitals under section 4417 of the BBA, and consistent with our earlier regulatory provision allowing for satellites for these hospitals, we believe it is also appropriate to revise the criteria in § 413.65(d)(7)(i) for hospitals excluded from the inpatient hospital PPS under section 4417 of the BBA. Specifically, we are proposing to require that satellites of a hospital that qualify for a PPS exclusion under § 412.23(e)(2) must be located within the same Metropolitan Statistical Area (MSA) as the hospital, instead of requiring that these satellites meet the existing requirement of determining that the satellite is located within the immediate vicinity of the hospital. Therefore, we are proposing to amend the regulations by adding subparagraph (iv) to existing § 413.65(d)(7) to allow for this revision to the provider-based rules. The satellites of these hospitals would still be required to comply with the other criteria in § 413.65.
        III. Collection of Information Requirements
        This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
        IV. Response to Comments

        Because of the large number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, if we proceed with a subsequent document, we will respond to the major comments in the preamble to that document.
        V. Regulatory Impact
        We have examined the impacts of this rule as required by Executive Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 96-354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more annually). This proposed rule is not a major rule because we have determined that the economic impact will be negligible since we know of only one hospital that may qualify for the revisions related to provider-based satellite facilities (of hospitals that qualify for LTH status under § 412.23(e)(2)) that are located within the same MSA as the main provider.
        The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $5 million or less annually. For purposes of the RFA, hospitals with provider-based satellite facilities are considered to be small entities. Individuals and States are not included in the definition of a small entity.
        In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis for any final rule that may have a significant impact on the operations of a substantial number of small rural hospitals. Such an analysis must conform to the provisions of section 603 of the RFA. With the exception of hospitals located in certain New England counties, for purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital with not more than 100 beds that is located outside of a Metropolitan Statistical Area (MSA) or New England County Metropolitan Area (NECMA). Section 601(g) of the Social Security Amendments of 1983 (Pub. L. 98-21) designated hospitals in certain New England counties as belonging to the adjacent NECMA. Thus, for purposes of the prospective payment system, we classify these hospitals as urban hospitals.
        Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million. This proposed rule will not have a significant economic effect on these governments or the private sector.
        Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct compliance costs on State and local governments, preempts State law, or otherwise has Federalism implications. This proposed rule will not have a substantial effect on States or local governments.
        We are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this rule will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.
        In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

          List of Subjects in 42 CFR Part 413
          Health facilities, Kidney diseases, Medicare, Puerto Rico, Reporting and recordkeeping requirements.

        For the reasons set forth in the preamble, HCFA proposes to amend 42 CFR chapter IV as follows:

          PART 413—PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES
          1. The authority citation for part 413 continues ro read as follows:

            Authority:
            Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and (n), 1871, 1881, 1883, and 1886 of the Social Security Act (42 U.S.C. 1302, 1395f(b), 1395g, 1395l, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww).

            Subpart E—Payments to Providers

          2. In § 413.65, paragraph (d)(7)(iv) is added to read as follows:

            § 413.65
            Requirements for a determination that a facility or an organization has provider-based status.

            (d) Requirements. * * *
            (7) Location in immediate vicinity. * * *
            (iv) A satellite facility that otherwise qualifies as a provider-based satellite of a main provider that is excluded from the prospective payment systems under § 412.23(e)(2) of this chapter, is considered to be located in the immediate vicinity of that main provider if it is located within the same Metropolitan Statistical Area as the main provider.

              (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program)

            Dated: July 18, 2000.

            Approved: July 27, 2000.
            Nancy-Ann Min DeParle,
            Administrator, Health Care Financing Administration.
            Donna E. Shalala,
            Secretary.

      [FR Doc. 00-19669 Filed 7-31-00; 2:48 pm]
      BILLING CODE 4120-01-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 52
        [EPA-R03-OAR-2015-0028; FRL-9925-47-Region 3]
        Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Permits for Construction and Major Modification of Major Stationary Sources for the Prevention of Significant Deterioration

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:

          The Environmental Protection Agency (EPA) is proposing conditional approval for two State Implementation Plan (SIP) revisions submitted by the West Virginia Department of Environmental Protection (WVDEP) for the State of West Virginia on July 1, 2014 and June 6, 2012. These revisions pertain to West Virginia's Prevention of Significant Deterioration (PSD) permit program and include provisions for preconstruction permitting requirements for major sources of fine particulate matter (PM2.5) found in West Virginia regulations. This action is being taken under the Clean Air Act (CAA).

          DATES:
          Written comments must be received on or before April 29, 2015.

          ADDRESSES:
          Submit your comments, identified by Docket ID Number EPA-R03-OAR-2015-0028 by one of the following methods:
          A. www.regulations.gov. Follow the on-line instructions for submitting comments.
          B. Email: campbell.dave@epa.gov.

          C. Mail: EPA-R03-OAR-2015-0028, David Campbell, Associate Director, Office of Permits and Air Toxics, Mailcode 3AP10, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
          D. Hand Delivery: At the previously-listed EPA Region III address. 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-R03-OAR-2015-0028. 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 email. 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 email comment directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

            Docket: All documents in the electronic docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittals are available at the West Virginia Department of Environmental Protection, Division of Air Quality, 601 57th Street SE., Charleston, West Virginia 25304.

          FOR FURTHER INFORMATION CONTACT:
          Mr. Paul Wentworth, (215) 814-2183, or by email at Wentworth.paul@epa.gov.

        SUPPLEMENTARY INFORMATION:

        I. Background
        The WVDEP submitted two SIP revisions to EPA on June 6, 2012 (the 2012 submittal) and on July 1, 2014 (the 2014 submittal). EPA is acting on these two submittals as a whole.1
           A summary of all the changes made in each of the submittals has been included in the docket for this action in a document titled, “Summary of West Virginia PSD Changes.” These SIP revision requests, if approved, would revise West Virginia's currently approved PSD program by amending Series 14 under Title 45 of West Virginia Code of State Rules (45CSR14).

            1 EPA is proposing to act on both SIP submittals in this notice because each submittal contains necessary procedural information related to West Virginia's revisions to its PSD regulations and development of its SIP submittals, which are required for SIP revisions by 40 CFR parts 51 and 52.

        On May 16, 2008, EPA promulgated a rule to implement the 1997 PM2.5 National Ambient Air Quality Standard (NAAQS), including changes to the New Source Review (NSR) program (the 2008 NSR PM2.5 Rule). See 73 FR 28321. The 2008 NSR PM2.5 Rule revised the NSR program requirements to establish the framework for implementing preconstruction permit review for the PM2.5 NAAQS in both attainment and nonattainment areas.2
           The 2008 NSR PM2.5 rule: (1) Required NSR permits to address directly emitted PM2.5 and precursor pollutants; (2) established significant emission rates for direct PM2.5 and precursor pollutants (including sulfur dioxide (SO2) and oxides of nitrogen (NOX)); (3) established PM2.5 emission offsets; and (4) required states to account for gases that condense to form particles (condensables) in PM2.5 emission limits.3

            2 The PSD permitting program is the NSR permit program in areas attaining a particular NAAQS.

            3 On October 25, 2012, EPA took final action to amend the definition of “regulated NSR pollutant” promulgated in the 2008 NSR PM2.5 Rule regarding the particulate matter (PM) condensable provision at 40 CFR 51.166(b)(49)(vi) and 52.21(b)(50)(i). See 77 FR 65107. The rulemaking removed the inadvertent requirement in the 2008 NSR PM2.5 Rule that the measurement of condensable “particulate matter emissions” be included as part of the measurement and regulation of “particulate matter emissions.”

        The 2008 NSR PM2.5 Rule (as well as the more general PM2.5 NAAQS implementation rule, the 2007 “Final Clean Air Fine Particle Implementation Rule” (2007 PM2.5 Implementation Rule) 4

          ), was the subject of litigation before the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) in Natural Resources Defense Council v. EPA (hereafter, NRDC v. EPA).5

           On January 4, 2013, the D.C. Circuit remanded to EPA both the 2007 PM2.5 Implementation Rule and the 2008 NSR PM2.5 Rule. The court found that in both rules EPA erred in implementing the 1997 PM2.5 NAAQS solely pursuant to the general implementation provisions of subpart 1 of part D of title I of the CAA (subpart 1), rather than pursuant to the additional implementation provisions specific to particulate matter in subpart 4 of part D of title I (subpart 4).6

           As a result, the D.C. Circuit remanded both rules and instructed EPA “to re-promulgate these rules pursuant to subpart 4 consistent with this opinion.” Although the D.C. Circuit declined to establish a deadline for EPA's response, EPA intends to respond promptly to the court's remand and to promulgate new generally applicable implementation regulations for the PM2.5 NAAQS in accordance with the requirements of subpart 4. In the interim, however, states and EPA still need to proceed with implementation of the 1997 PM2.5 NAAQS in a timely and effective fashion in order to meet statutory obligations under the CAA and to assure the protection of public health intended by those NAAQS. In a June 2, 2014 final rulemaking entitled “Identification of Nonattainment Classification and Deadlines for Submission of State Implementation Plan (SIP) Provisions for the 1997 Fine Particle (PM2.5) National Ambient Air Quality Standard (NAAQS) and 2006 PM2.5 NAAQS; Final Rule,” (79 FR 31566), EPA identified the classification status under subpart 4 for areas currently designated nonattainment for the 1997 and 2006 PM2.5 NAAQS.7

            4 72 FR 20586 (April 25, 2007).

            5 706 F.3d 428 (D.C. Cir. 2013).

            6 The court's opinion did not specifically address the point that implementation under subpart 4 requirements would still require consideration of subpart 1 requirements, to the extent that subpart 4 did not override subpart 1. EPA assumes that the court presumed that EPA would address this issue of potential overlap between subpart 1 and subpart 4 requirements in subsequent actions.

            7 That June 2, 2014 rulemaking (79 FR 31566) also established a December 31, 2014 deadline for the submission of any additional attainment related SIP elements that may be needed to meet the applicable requirements of subpart 4.

        As the requirements of Subpart 4 only pertain to nonattainment areas, EPA does not consider the portions of the 2008 NSR PM2.5 Rule that address requirements for PM2.5 attainment and unclassifiable areas to be affected by the NRDC v. EPA opinion. Moreover, EPA does not anticipate the need to revise any PSD permitting requirements promulgated in the 2008 NSR PM2.5 Rule in order to comply with the D.C. Circuit's decision. This proposed rulemaking addresses West Virginia's PSD regulations. Thus, EPA has evaluated the regulations with applicable PSD requirements in the CAA, its implementing regulations, and the 2008 NSR PM2.5 Rule.

        The CAA's PSD provisions also establish maximum allowable increases over baseline concentrations—also known as “increments”—for certain pollutants. EPA has the task of promulgating regulations to prevent the significant deterioration of air quality that would result from the emissions of pollutants EPA began regulating after Congress enacted the PSD provisions in the CAA, which includes PM2.5. The PSD provisions establish preconstruction review and permitting of new or modified sources of air pollution. In 2007, EPA proposed a rule establishing increments for PM2.5 and also proposed two screening tools that would exempt permit applicants from some air quality analysis and monitoring required for PSD: Significant impact levels (SILs) and significant monitoring concentration (SMC). See 72 FR 54112 (September 21, 2007). In our October 20, 2010 final rule (the PM2.5 PSD Increments-SILs-SMC Rule), EPA set values for both SILs and SMC for PM2.5.
          See 75 FR 64864.
        The Sierra Club challenged EPA's authority to implement PM2.5 SILs and SMC for PSD purposes as promulgated in the PM2.5 PSD Increments-SILs-SMC Rule. See Sierra Club v. EPA, 705 F.3d 458 (D.C. Cir. 2013). On January 22, 2013, the D.C. Circuit granted a request from EPA to vacate and remand to the Agency the portions of the PM2.5 PSD Increments-SILs-SMC Rule addressing the SILs for PM2.5 (found in paragraph (k)(2) in 40 CFR 51.166 and 52.21), except for the parts codifying the PM2.5 SILs at 40 CFR 51.165(b)(2), so that the EPA could voluntarily correct an error in the provisions. Id. at 463-66. The D.C. Circuit also vacated parts of the PSD Increments-SILs-SMC Rule establishing the PM2.5 SMC, finding that the Agency had exceeded its statutory authority with respect to these provisions. Id. at 469.

        In response to the D.C. Circuit's decision, EPA took final action on December 9, 2013 to remove the SIL provisions from the Federal PSD regulations in 40 CFR 52.21 and to revise the SMC for PM2.5 to zero micrograms per cubic meter. See 78 FR 73698. Because the D.C. Circuit vacated the SMC provisions in 40 CFR 51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c), EPA revised the existing concentration for the PM2.5 SMC listed in sections 51.166(i)(5)(i)(c) and 52.21(i)(5)(i)(c) to zero micrograms per cubic meter. EPA did not entirely remove PM2.5 as a listed pollutant in the SMC provisions because to do so might lead to the issuance of permits that contradict the holding of the D.C. Circuit as to the statutory monitoring requirements. Id. (providing EPA's explanation for including the zero micrograms per cubic meter SMC).

        On May 9, 2013, EPA had disapproved a narrow portion of a SIP revision submitted by the State of West Virginia on August 31, 2011 for revising West Virginia's PSD requirements in 45 CSR14 because the submittal did not satisfy the Federal requirement for inclusion of condensable emissions of PM (condensables) within the definition of “regulated new source review (NSR) pollutant” (at 45CSR14 section 2.66) for PM2.5 and PM emissions less than or equal to ten micrometers in diameter (PM10).8

            8 See 78 FR 27062 (May 9, 2013). The limited disapproval of the narrow portion of the August 31, 2011 SIP provision (concerning 45CSR14 section 2.66) is discussed in 78 FR 27062 and in 40 CFR 52.2522(j)(1) specifically.

        II. Summary of SIP Revision and EPA Analysis
        A. Summary of SIP Revision

        Specifically, the revisions submitted by WVDEP on July 1, 2014 and June 6, 2012 involve amendments to 45CSR14 (Permits for Construction and Major Modification of Major Stationary Sources for the Prevention of Significant Deterioration) based on the Federal regulatory actions discussed above in section I. A summary of the changes made in the 2012 and 2014 submittals are available in the docket in a document titled, “Summary of West Virginia NSR Changes.” Generally, the revisions in the 2012 submittal were submitted to incorporate provisions related to the 2008 NSR PM2.5 Rule. The 2014 submittal revises certain subdivisions of the 2012 submittal as shown in the table below:

            Rule 45CSR14 subdivision
            Description of change

            2.66.a.1
            Added PM condensable emissions to definition of “regulated NSR pollutant”.

            2.66.a.2
            Added language identifying precursors to NAAQS pollutants to the definition of “regulated NSR pollutant”.

            16.7.c

            Deleted 24-hour de minimis air quality impact concentration value for PM2.5 (aka SMC for PM2.5).

            16.1.a & b
            Added provision exempting requirements of 9.1 for stationary sources based on completeness date of permit applications.

            9.2
            Significant Impact Levels. Deleted this provision in its entirety.

        In general, the 2014 submittal adds PM condensable emissions to the definition of “regulated NSR pollutant” and deletes SILs and SMC for PM2.5 in the 45CSR14 provisions submitted for SIP approval.
        B. EPA Analysis

        EPA finds the revisions to 45CSR14 contained in the 2012 submittal and the 2014 submittal which were submitted by WVDEP for approval mirror the PSD requirements of the 2008 NSR PM2.5 Rule with certain exceptions described in the next paragraph. The 2014 submittal addresses and corrects the deficiency identified in EPA's May 9, 2013 disapproval (78 FR 27062) by adding language to the provision at 45CSR14 section 2.66.a.1 which now includes PM condensable emissions in the definition of “regulated NSR pollutant.” Thus, EPA finds West Virginia has addressed the deficiency noted in our limited disapproval in 78 FR 27062.

        However, while the 2014 submittal appropriately removes SILs for PM2.5 consistent with the D.C. Circuit's Sierra Club v. EPA decision and our final December 9, 2013 rulemaking (78 FR 73698), West Virginia's PSD provision at 45CSR14-16.7.c (included in the 2014 submittal) does not include a SMC value of zero micrograms per cubic meter for PM2.5 consistent with the D.C. Circuit's Sierra Club v. EPA decision and our December 9, 2013 rulemaking (78 FR 73698) which addressed the D.C. Circuit's vacature of the SMC provisions in 40 CFR parts 51 and 52 for PM2.5. Therefore, West Virginia's PSD regulation, 45CSR14, does not fully meet the requirements for PSD programs as set forth in the 2008 NSR PM2.5 Rule, the D.C. Circuit's decision on SILs and SMC in Sierra Club v. EPA, and in EPA's December 9, 2013 rulemaking addressing that decision for SILs and SMC.

        However, on January 20, 2015, West Virginia committed to submitting an additional SIP revision with a revised PSD regulation at 45CSR14-16.7.c which will incorporate a SMC value of zero micrograms per cubic meter for PM2.5 to address this discrepancy. West Virginia committed to submitting this SIP revision no later than one year following the effective date of the final rulemaking notice for conditional approval of the 2012 and the 2014 submittals so that EPA can conditionally approve the 2012 and 2014 submittals.9

          See CAA section 110(k)(4). With the exception of the absence of the SMC value of zero micrograms per cubic meter for PM2.5 which WVDEP has committed to address, EPA finds the 2012 and 2014 submittals meet applicable requirements for a PSD permitting program in the CAA, its implementing regulations, and the 2008 NSR PM2.5 Rule. The EPA is soliciting public comments on the issues discussed in this document. Any comments submitted in a timely manner will be considered before taking final action.

            9 West Virginia's letter from the Secretary of WVDEP committing to submit a revised provision in 45CSR14 to address the SMC for PM2.5 is available in the docket for this rulemaking (EPA-R03-OAR-2015-0028) and available online at www.regulations.gov.

        III. Proposed Action

        EPA is proposing conditional approval of these West Virginia SIP revisions, the 2012 and 2014 submittals, because West Virginia is committing to submit an additional SIP revision addressing the deficiency identified by EPA regarding the deletion of the PM2.5 SMC within one year of the date of EPA's final conditional approval and because the submittals otherwise meet CAA requirements as discussed in this proposed rulemaking. Once EPA has determined that West Virginia has satisfied this condition, the conditional approval of the 2012 and 2014 submittals will become a full approval. Should West Virginia fail to meet the condition specified above, the conditional approval of the 2012 and 2014 submittals will convert to a disapproval pursuant to CAA section 110(k)(4).

        The full or partial disapproval of a SIP revision triggers the requirement under CAA section 110(c) that EPA promulgate a federal implementation plan (FIP) no later than two years from the date of the disapproval unless the State corrects the deficiency, and the Administrator approves the plan or plan revision before the Administrator promulgates such FIP. EPA has determined that West Virginia's 2014 submittal has rectified the deficiency regarding including condensables in the definition of regulated NSR pollutant noted in our limited disapproval in 78 FR 27062. Therefore, upon final approval of the 2014 submittal, the EPA is no longer required to promulgate a FIP to address the issue of PM condensables in the definition of regulated NSR pollutant for West Virginia's PSD permit program, and our narrow disapproval of the August 31, 2011 PSD SIP (for failure to include condensables in definition of regulated NSR pollutant) will become a full approval. However, EPA is proposing conditional approval for the 2012 and 2014 submittals due to West Virginia's lack of a PM2.5 SMC with the value of zero micrograms per cubic meter.
        IV. Incorporation by Reference

        In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the WV regulations at 45CSR14 regarding the Prevention of Significant deterioration permitting requirements as discussed in section III of this preamble. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.com and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).
        V. Statutory and Executive Order Reviews
        Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
        • Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

        • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

        • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
        • 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);
        • Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
        • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
        • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
        • Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
        • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
        In addition, this proposed rule, relating to West Virginia's PSD program, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

          List of Subjects in 40 CFR Part 52
          Environmental protection, Air pollution control, Incorporation by reference, Carbon monoxide, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

          Authority:
           42 U.S.C. 7401 et seq.

          Dated: March 12, 2015.
          William C. Early,
          Acting Regional Administrator, Region III.

      [FR Doc. 2015-07222 Filed 3-27-15; 8:45 am]
       BILLING CODE 6560-50-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Parts 223, 224 and 226
        [Docket No. 010731194-1194-01; I.D. 070601B]
        Listing Endangered and Threatened Species and Designating Critical Habitat:  Petition To List Southern Resident Killer Whales

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Notice of finding; request for information.

          SUMMARY:

          NMFS received a petition to list the Eastern North Pacific Southern Resident stock of killer whales (Orcinus orca) as endangered or threatened species under the Endangered Species Act (ESA) and to designate critical habitat for this stock under that Act.  NMFS determined that the petition presents substantial scientific information indicating that a listing may be warranted and will initiate an ESA status review.  NMFS solicits information and comments pertaining to these killer whale populations and their habitats and seeks suggestions for peer reviewers for any proposed listing determination that may result from the agency’s status review of the species.

          DATES:
          Information and comments on the action must be received by October 12, 2001.

          ADDRESSES:
          Information and comments on this action should be submitted to Chief, Protected Resources Division, NMFS, 525 NE Oregon Street—Suite 500, Portland, OR 97232.  Comments will not be accepted if submitted via email or the internet.  However, comments may be sent via fax to (503) 230-5435.

          FOR FURTHER INFORMATION CONTACT:
          Garth Griffin, NMFS, Northwest Region, (503) 231-2005 or Tom Eagle, NMFS, Office of Protected Resources, (301) 713-2322 ext. 105.

        SUPPLEMENTARY INFORMATION:

        Electronic Access

        Reference materials regarding this rule can also be obtained from the internet at http://www.nwr.noaa.gov.
        Background

        On May 2, 2001, NMFS received a petition from the Center for Biological Diversity, Center for Whale Research, The Whale Museum, Ocean Advocates, Washington Toxics Coalition, Orca Conservancy, American Cetacean Society, Friends of the San Juans, People for Puget Sound, Cascade Chapter of the Sierra Club and  Ralph Munro, to list the Eastern North Pacific Southern Resident stock of killer whales as an endangered or threatened species under the ESA.  The petitioners further requested concurrent designation of critical habitat for this species in accordance with the ESA.  On July 16, 2001, NMFS received a letter from the petitioners asking NMFS to add Project SeaWolf as an additional co-petitioner.  Copies of this petition are available from NMFS (See ADDRESSES).
        The petition presents detailed narrative information, based on the available data from the annual killer whale censuses, that show that the stock (as defined) has gone through periods of growth and decline from a low of fewer than 70 animals in 1973 to a high of 97 individuals in 1996 followed by period of decline to 82 individuals at the beginning of 2000.  The petition further describes the killer whale’s distribution worldwide and provides arguments for further delineating Southern Resident killer whales as a distinct population segment.  The arguments include morphological, dietary, behavioral and genetic differences between groups of killer whales in the Pacific Northwest, and exclusive utilization of summertime home range.  Additional arguments are presented based on regional cultural significance and management status under the Marine Mammal Protection Act (MMPA).  Variability in recruitment and survival, reduced food resources, residual effects from live captures in the 1960s and 70s on the current age and sex structure of the population, behavioral changes associated with increased whale watching disturbance, and increased levels of toxic contaminants are highlighted as possible threats faced by the species.  The petition includes a population viability analysis, distributional maps, and a bibliography of supporting documentation.
        Prior to receiving the petition, and in response to concerns raised over a recent decline in the number of Southern Resident killer whales, NMFS convened a workshop in April 2000 to review the status of ongoing killer whale research, help coordinate future research efforts and discuss many of the same issues raised in the petition.  Workshop participants presented and discussed information on killer whale population dynamics, status of adjacent killer whale communities, genetic evidence of stock structure, bioaccumulation of contaminants, increased whale watching pressure, and prey availability.  Census counts, begun in 1974 using photo-identification methodology, revealed fluctuations in the number of whales from year to year and allowed the documentation of individual births and deaths within the Southern Resident stock.  Analysis of the available genetic data showed that the Southern Resident killer whales are genetically distinguishable from the northern resident stock, the nearest (geographically) resident killer whale group, but that they share common genetic traits with other resident groups farther to the north, in Alaska.  Genetic information also showed that Southern Resident whales are different from the sympatric Eastern North Pacific Transient stock of killer whales.  Contaminant analysis showed that, for males, Southern Residents have higher levels of some contaminants than northern residents or resident whales in Alaska but significantly lower than transient killer whales.  Data on the growth of recreational and commercial whale watching, during the past 20 years, showed that summer vessel traffic increased in the seasonal core range of the Southern Residents, but studies on the influence of vessels on the behavior, feeding and energy expenditures of these whales have been inconclusive.  Little is known about the winter foraging habitat or prey of the Southern Residents.  However, the summer diet is dominated by salmonids and chinook salmon have been observed to be a preferred prey in Puget Sound and the Northwest Straits.  Data on seasonal abundance of chinook and other salmonids in Washington indicate periodic declines but detailed information on prey density, trends in wild versus hatchery fish, and foraging success between Southern Resident pods and between adjacent killer whale populations were unavailable at the workshop.  Workshop participants noted that resident killer whale stocks in British Columbia (including Southern Residents) were listed as threatened by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC) but that listing under Canadian law does not carry the same legal definitions or mandates as the ESA.
        Analysis of Petition
        Section 4 (b)(3) of the ESA contains provisions concerning petitions from interested persons requesting the Secretary of Commerce (Secretary) to list certain species under the ESA (16 U.S.C. 1533 (b)(3)(A)).  Section 4 (b)(3)(A) requires that, to the maximum extent practicable, within 90 days after receiving such a petition, the Secretary must make a finding whether the petition presents substantial scientific information indicating that the petitioned action may be warranted.  This includes determining whether there is evidence that the subject populations may qualify as a “species” under the ESA, in accordance with NMFS/U.S. Fish and Wildlife Service policy regarding the identification of distinct vertebrate population segments (61 FR 4722, February 7, 1996).
        Regulations implementing the ESA (50 CFR 424.14 (b)) define “substantial information” as the amount of information that would lead a reasonable person to believe that the measure proposed in the petition may be warranted.  In evaluating a petitioned action, NMFS considers several factors, including whether the petition contains detailed narrative justification for the recommended measure, describing, based on available information, past and present numbers and distribution of the species involved and any threats faced by the species (50 CFR 424.14 (b)(2)(ii)).  In addition, NMFS considers whether the petition provides information regarding the status of the species over all or a significant portion of its range (50 CFR 424.14 (b)(2)(iii)).
        NMFS evaluated whether the petition met the standard for “substantial information” and concluded it was appropriate to accept the petition to list the species.  The petition highlights key issues for consideration by NMFS, including: (1) genetic, behavioral, and ecological evidence bearing on the issue of whether to define Southern Resident killer whales as a distinct population segment; (2) population data documenting a recent decline in Southern Resident killer whales and analyses indicating that these whales may be at some risk of extinction; and (3) an array of threats that may account for the decline in Southern Resident killer whales.
        Petition Finding

        After reviewing the information contained in the petition, as well as other available information, NMFS determines that the petition presents substantial scientific information indicating the petitioned action may be warranted.  In accordance with section 4 (b)(3)(B) of the ESA, NMFS will complete a status review and report its findings by May 2, 2002.
        Listing Factors and Basis for Determination
        Under section 4 (a)(1) of the ESA, a species can be determined to be threatened or endangered based on any of the following factors: (1) The present or threatened destruction, modification, or curtailment of a species' habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms; or (5) other natural or manmade factors affecting the species continuing existence.  Listing determinations are based solely on the best available scientific and commercial data after taking into account any efforts being made by any state or foreign nation to protect the species.
        Information Solicited

        To ensure that the status review is complete and based on the best available scientific and commercial data, NMFS solicits information and comments concerning the status of killer whale populations world wide with emphasis in the Eastern North Pacific Ocean from California to Alaska (see DATES and ADDRESSES).  Specifically, the agency is seeking available information on: (1) historical and current known ranges of resident (fish eating) and transient (mammal-eating) killer whales; (2) spatial and seasonal distribution with particular focus on current and historical habitat utilization; (3) genetic variability in resident, transient, and offshore killer whale populations; (4) demographic movements among resident or transient killer whales; (5) trends in killer whale foraging habits and seasonal prey abundance; (6) trends in environmental contamination by persistent organic pollutants (e.g., polychlorinated-biphenyls (PCBs) including congener specific data) as well as other contaminants (e.g. toxic metals); (7) contaminant burdens in prey species, especially salmonids; (8) impacts caused by human recreational activities (e.g., whale watching, boating); (9) historic removals of killer whales including human caused mortality associated with live capture operations, military activities, or fisheries interactions; (10) current or planned activities and their possible impacts on this species (e.g., removals or habitat modifications); (11) efforts being made to protect resident killer whales or improve their habitat; and (12) non-human related factors that may have contributed to the recent decline of the Southern Resident killer whale (i.e., climatic or oceanographic regime shifts, diseases, biotoxins).
        NMFS also requests information describing the quality and extent of marine habitats for Southern Resident killer whales, as well as information on areas that may qualify as critical habitat.  Areas that include the physical and biological features essential to the recovery of the species should be identified.  Essential features include, but are not limited to the following: (1) Habitat for individual and population growth, and for normal behavior; (2) food, water, air, light, minerals, or other nutritional or physiological requirements; (3) cover or shelter; (4) sites for reproduction and rearing of offspring; and (5) habitats that are protected from disturbance or are representative of the historic geographical and ecological distributions of the species.  NMFS is also seeking information and maps describing natural and manmade changes within the species’ current and historical range in the Eastern North Pacific Ocean from California to Alaska.
        For areas potentially qualifying as critical habitat, NMFS also requests information describing (1) the activities that affect the area or could be affected by the designation, and (2) the economic costs and benefits of additional requirements of management measures likely to result from the designation.  The economic cost to be considered in a critical habitat designation under the ESA is the probable economic impact “of the [critical habitat] designation upon proposed or ongoing activities” (50 CFR 424.19).  NMFS must consider the incremental costs specifically resulting from a critical habitat designation that are above the economic effects attributable to listing the species.  Economic effects attributable to listing include actions resulting from section 7 consultations under the ESA to avoid jeopardy to the species and from the taking prohibitions under section 9 or 4 (d) of the ESA.  Comments concerning economic impacts should distinguish the costs of listing from the incremental costs that can be directly attributed to the designation of specific areas as critical habitat.
        On July 1, 1994, NMFS, jointly with the U.S. Fish and Wildlife Service, published a series of policies regarding listings under the ESA, including a policy for peer review of scientific data (59 FR 34270).  The intent of the peer review policy is to ensure that listings are based on the best scientific and commercial data available.  NMFS now solicits the names of recognized experts in the field who could take part in the peer review process for the agency’s status review of Southern Resident killer whales.  Peer reviewers may be selected from the academic and scientific community, tribal and other Native American groups, Federal and state agencies, the private sector, and public interest groups.

          Authority:
          Authority: 16 U.S.C. 1531 et seq.

          Dated: August 6, 2001.
          William T. Hogarth,
          Acting Assistant Administrator for Fisheries, National Marine Fisheries Service.

      [FR Doc. 01-20282 Filed 8-10-01; 8:45 am]
      BILLING CODE  3510-22-S


        DEPARTMENT OF TRANSPORTATION
        National Highway Traffic Safety Administration
        49 CFR Part 571
        [Docket No. NHTSA-2010-0132]
        RIN 21217-AK17
        Federal Motor Vehicle Safety Standards; New Pneumatic Tires for Motor Vehicles With a Gross Vehicle Weight Rating (GVWR) of More Than 4,536 Kilograms (10,000 Pounds) and Motorcycles

          AGENCY:
          National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

          ACTION:
          Extension of comment period.

          SUMMARY:
          NHTSA has received a petition asking the agency to extend the comment period for its proposal to upgrade the Federal motor vehicle safety standard (FMVSS) that applies to new pneumatic tires for use on vehicles with a gross vehicle weight rating (GVWR) greater than 10,000 pounds and motorcycles. In the proposal, NHTSA established a deadline for the submission of written comments of November 29, 2010. In light of that petition and the need to ensure that all interested parties have a sufficient amount of time to fully develop their comments, the agency is extending the deadline for the submission of written comments by 30 days.

          DATES:
          Written comments must be received by December 29, 2010.

          ADDRESSES:
          You may submit comments (identified by the NHTSA Docket ID Number above) by any of the following methods:
          • Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting comments.
          • Mail: Docket Management Facility: U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.
          • Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.
          • Fax: 202-493-2251.

            Privacy Act: Anyone is able to 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 DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

            Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov or the street address listed above. Follow the online instructions for accessing the dockets.

          FOR FURTHER INFORMATION CONTACT:
          George Soodoo, NHTSA Office of Rulemaking (Telephone: 202-366-2720) (Fax: 202-493-2739) or Thomas Healy, NHTSA Office of Chief Counsel (Telephone: 202-366-7161) (Fax: 202-366-3820). The mailing address for these officials is: National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building, Washington, DC 20590.

        SUPPLEMENTARY INFORMATION:
        NHTSA issued a notice of proposed rulemaking (NPRM) proposing to upgrade FMVSS No. 119 (49 CFR 571.119), which applies to new pneumatic tires for vehicles with a GVWR greater than 10,000 pounds and motorcycles. The NPRM was published on September 29, 2010 (75 FR 60037, Docket No. NHTSA-2010-0132). In the NPRM, among other matters, NHTSA proposed to amend FMVSS No. 119 to adopt a more stringent endurance test and a new high speed test for heavy vehicle tires with a load range of F, G, H, J, and L.
        The Rubber Manufacturers Association (RMA), which represents manufacturers of finished rubber products, including tire manufacturers, has petitioned for an extension of the comment period on the NPRM. RMA said that it is requesting a 30-day extension so that its members can complete all of their additional testing to evaluate the more stringent endurance test proposed by the agency and to develop new data to demonstrate differences in outcomes with tire break-in versus no break-in for the new proposed high speed test. RMA indicated that it also intends to supplement its earlier test data submitted to the agency on April 14, 2009. RMA believes that the earlier data set submitted to the docket, combined with additional new data, will assist NHTSA in evaluating RMA's comments and arriving at a final rule. RMA maintains that its members require several weeks to complete even a small test program of the 47-hour endurance test. Therefore, RMA indicates that it is not possible for its members to complete all of their additional testing and have it ready for submittal by November 29, 2010.
        In considering the extension request, NHTSA weighed the complexity and importance of this rulemaking and the basis for the request. We have decided there is good cause to grant the petition and extend the comment period 30 days. The extension is in the public interest since it will provide the public additional time to prepare and submit useful technical information that should benefit agency decision-making in this rulemaking action. Accordingly, NHTSA extends the period for the submission of written comments in this proceeding to December 29, 2010.

          Authority:
          49 U.S.C. 322, 30111, 30115, 30166 and 30177; delegation of authority at 49 CFR 1.50.

          Issued: November 24, 2010.
          Joseph S. Carra,
          Acting Associate Administrator for Rulemaking.

      [FR Doc. 2010-30096 Filed 11-24-10; 4:15 pm]
      BILLING CODE 4910-56-P