Protection of Stratospheric Ozone: Adjusting Allowances for Class I Substances for Export to Article 5 Countries, 49395-49399 [E6-13951]

Download as PDF Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Proposed Rules 40 CFR Part 82 [EPA–HQ–OAR–2005–0151, FRL–8212–5] RIN 2060–AK45 Protection of Stratospheric Ozone: Adjusting Allowances for Class I Substances for Export to Article 5 Countries Environmental Protection Agency (EPA). ACTION: Notice of proposed rulemaking. sroberts on PROD1PC70 with PROPOSALS AGENCY: SUMMARY: This proposed action amends previous action by the Agency regarding the allocation of Article 5 allowances that permit production of ozonedepleting substances (ODS) that are Class I, Group I controlled substances solely for export to developing countries to meet those countries’ basic domestic needs. Specifically, this action will remove the 2007–2009 phasedown step for companies that manufacture CFCs– 11, –12, or –114 for export to meet the basic domestic needs of developing countries. The Agency is taking this action in response to notification that there would otherwise be a shortfall in the availability of pharmaceutical-grade CFCs for use in metered dose inhalers in developing countries. In a final rule published December 29, 2005, EPA established initial baselines for each company that are far more stringent than required under the Beijing Adjustments to the Montreal Protocol on Substances that Deplete the Ozone Layer (the Montreal Protocol), which set out restrictions for production to meet basic domestic needs. Therefore, even without the 2007–2009 step-down reduction, the U.S. will be at production levels to meet basic domestic needs that are far below those allowed under the Beijing Adjustments. This action is taken in accordance with the Montreal Protocol and the Clean Air Act (CAA). DATES: Written comments on the rule must be received on or before September 22, 2006. Any party requesting a public hearing must notify the contact person listed below by 5 p.m. eastern standard time on August 28, 2006. If a hearing is requested it will be held on September 7, 2006 and comments will be due to the Agency October 10, 2006. EPA will post information regarding a hearing, if one is requested, on the Ozone Protection Web site https://www.epa.gov/ozone. Persons interested in attending a public hearing should consult with the contact person below regarding the location and time of the hearing. VerDate Aug<31>2005 15:59 Aug 22, 2006 Jkt 208001 Submit your comments, identified by Docket ID No. OAR–2005– 0151, by one of the following methods: • https://www.regulations.gov: follow the on-line instructions for submitting comments. • E-mail: A-and-R-docket@epa.gov. • Fax: 202–566–1741. • Mail: Air Docket, Environmental Protection Agency, Mailcode: 6102T, 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 B108, Mail Code 6102T, Washington, DC 20004. 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–2005– 0151 EPA’s policy is that all comments received will be included in the public docket without change and may be made available online at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or e-mail. The https:// www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA’s public docket visit the EPA Docket Center homepage at https:// 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 ADDRESSES: ENVIRONMENTAL PROTECTION AGENCY PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 49395 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 B102, 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: Cindy Axinn Newberg, EPA, Stratospheric Protection Division, Office of Atmospheric Programs, Office of Air and Radiation (6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, (202) 343–9729, newberg.cindy@epa.gov. Table of Contents I. What Is the Legislative and Regulatory Background of the Phaseout Regulations for Ozone-Depleting Substances? II. Today’s Action III. Statutory and Executive Order Reviews A. Executive Order No. 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility D. Unfunded Mandates Reform Act E. Executive Order No. 13132: Federalism F. Executive Order No. 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order No. 13045: Protection of Children From Environmental Health & Safety Risks H. Executive Order No. 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer Advancement Act J. Congressional Review Act I. What Is the Legislative and Regulatory Background of the Phaseout Regulations for Ozone-Depleting Substances? The current regulatory requirements of the Stratospheric Ozone Protection Program that limit production and consumption of ozone-depleting substances (ODSs) can be found at 40 CFR part 82, subpart A. The regulatory program was originally published in the Federal Register on August 12, 1988 (53 FR 30566), in response to the 1987 signing and subsequent ratification of the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol). The U.S. was one of the original signatories to the 1987 Montreal Protocol and the U.S. ratified the Protocol on April 21, 1988. Congress E:\FR\FM\23AUP1.SGM 23AUP1 sroberts on PROD1PC70 with PROPOSALS 49396 Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Proposed Rules then enacted, and President Bush signed into law, the Clean Air Act Amendments of 1990 (CAAA of 1990), which included Title VI on Stratospheric Ozone Protection, codified as 42 U.S.C. Chapter 85, Subchapter VI, to ensure that the United States could satisfy its obligations under the Montreal Protocol. EPA issued new regulations to implement this legislation and has made several amendments to the regulations since. The requirements contained in the final rules published in the Federal Register on December 20, 1994 (59 FR 65478) and May 10, 1995 (60 FR 24970) establish an Allowance Program. The Allowance Program and its history are described in the notice of proposed rulemaking published in the Federal Register on November 10, 1994 (59 FR 56276). The control and the phaseout of the production and consumption of Class I ODSs as required under the Protocol and the CAA are accomplished through the Allowance Program. In developing the Allowance Program, we collected information on the amounts of ODSs produced, imported, exported, transformed and destroyed within the U.S. for specific baseline years for specific chemicals. This information was used to establish the U.S. production and consumption ceilings for these chemicals. The data were also used to assign companyspecific production and import rights to companies that were in most cases producing or importing during the specific year of data collection. These production or import rights are called ‘‘allowances.’’ Due to the complete phaseout of many ODSs, the quantities of allowances granted to companies for those chemicals were gradually reduced and eventually eliminated. Production allowances and consumption allowances no longer exist for any ODSs that are Class I controlled substances. All production or consumption of Class I controlled substances is prohibited under the Montreal Protocol and the CAA, except for a few narrow exemptions. In the context of the regulatory program, the use of the term ‘‘consumption’’ may be misleading. Consumption does not mean the ‘‘use’’ of a controlled substance, but rather is defined as the formula: production + imports¥exports, of controlled substances (Article 1 of the Protocol and Section 601 of the CAA). Class I controlled substances that were produced or imported through the expenditure of allowances prior to their phaseout date may continue to be used by industry and the public after their phaseout date except where the VerDate Aug<31>2005 15:59 Aug 22, 2006 Jkt 208001 regulations include explicit use restrictions. Use of such substances may be subject to other regulatory limitations. The specific names and chemical formulas for the Class I controlled substances are in Appendix A and Appendix F in Subpart A of 40 CFR Part 82. The specific names and chemical formulas for the Class II controlled substances are in Appendix B and Appendix F in Subpart A. Although the regulations phased out the production and consumption of Class I controlled substances, a very limited number of exemptions exist, consistent with U.S. obligations under the Montreal Protocol. The regulations allow for the manufacture of phased-out Class I controlled substances provided the substances are either transformed or destroyed. They also allow limited manufacture if the substances are (1) exported to meet the basic domestic needs of countries operating under Article 5 of the Montreal Protocol or (2) produced for essential or critical uses as authorized by the Montreal Protocol and the regulations. Limited exceptions to the ban on the import of phased-out Class I controlled substances also exist if the substances are: (1) Previously used, (2) imported for essential or critical uses as authorized by the Montreal Protocol and the regulations, (3) imported for destruction or transformation only, or (4) a transhipment or (5) a heel (a small amount of controlled substance remaining in a container after it is discharged or off-loaded) (40 CFR 82.4). On December 29, 2005, EPA published a final rule in the Federal Register (70 FR 77042) concerning production of specific Class I controlled substances for export to meet the basic domestic needs of developing countries (‘‘Article 5’’ countries). It established a new Article 5 allowance baseline for Class I controlled substances, established a schedule for phased reductions in such allowances, and extended the time allowed for Article 5 production for methyl bromide. Article 5 allowances are solely for production to meet the basic domestic needs of developing countries referred to in the Protocol as ‘‘Article 5’’ parties. This action amends the schedule for phased reductions in Article 5 allowances for companies that produce and export Class I, Group I substances to meet the basic domestic needs of Article 5 countries. II. Today’s Action Under the Montreal Protocol, industrialized countries and developing countries have different schedules for PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 phasing out the production and import of ODSs. Developing countries operating under Article 5, paragraph 1 of the Montreal Protocol in most cases have additional time in which to phase out ODSs. The Parties to the Montreal Protocol recognized that it would be inadvisable for developing countries to spend their scarce resources to build new ODS manufacturing facilities to meet their basic domestic needs as industrialized countries phase out. The Parties therefore decided to permit a small amount of production in industrialized countries, in addition to the amounts permitted under those countries’ phaseout schedules, for export to meet the basic domestic needs of developing countries. The adjustments to the Montreal Protocol adopted by the Parties at their 11th meeting in Beijing required Parties that manufacture ODSs for basic domestic needs to establish baselines for such production, calculated based on the average quantity of the ODS exported to Article 5 countries over a specified range of years. The adjustments also instituted a reduction schedule for Article 5 manufacture which reflects the reduction schedule in place for developing country ODS consumption. The Beijing Adjustments underscore the Parties’ concern that global oversupply of certain Class I ODSs is interfering with the transition to alternatives. The oversupply of these ODSs results in low prices that make it difficult for non-ozone-depleting alternatives to compete in the marketplace. Businesses and individuals thus lack an economic incentive to transition to alternatives. The Beijing baseline calculation was designed to overcome this problem with respect to Article 5 countries by reducing supply to those countries. The price of these ODSs should rise to reflect the decrease in supply. In response to the Beijing Adjustments, EPA published a final rule in the Federal Register on December 29, 2005 (70 FR 77042). The Beijing Adjustments to the Protocol, Article 2A, paragraphs 4–7 state that an industrialized Party’s allowable production of CFCs–11, –12, –113, –114, and –115, referred to under the Clean Air Act as Class I, Group I substances, to meet the basic domestic needs of Article 5 Parties shall be measured against ‘‘the annual average of its production of [these substances] for basic domestic needs for the period 1995 to 1997 inclusive.’’ EPA’s December 29, 2005 action was far more stringent than the requirements set forth in Beijing. The Agency established a baseline for Class I, Group I substances E:\FR\FM\23AUP1.SGM 23AUP1 sroberts on PROD1PC70 with PROPOSALS Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Proposed Rules using the more recent export data from the years 2000–2003, years in which there were far fewer exports. Therefore, instead of establishing an aggregate baseline for Class I, Group I substances of 9,951 metric tons—reflecting the 1995–1997 average called for by the Beijing Adjustments—EPA’s December 29, 2005 final rule established a more stringent baseline of 345 metric tons, reflecting export data from 2000–2003, believing that more recent export data represented a truer picture of the actual basic domestic needs for these chemicals in developing countries and would thereby address the concerns regarding global oversupply of CFCs. After publication of the December 29, 2005 final rule, EPA was informed that although there is a global oversupply of CFCs in general, there are not sufficient supplies of pharmaceutical-grade CFCs available for use in metered dose inhalers in developing countries. Pharmaceutical-grade CFCs are more pure than a typical batch of CFCs and have to meet stringent specifications set out by regulatory authorities if they are to be used in medical devices. Developed countries like the United States have already reached their phaseout date for the production and consumption of CFCs. Under the Montreal Protocol, once a Party has reached the phaseout date for CFCs it is allowed to apply for an essential use exemption, which permits the Party to consume limited amounts of CFCs for essential uses such as certain metered dose inhalers. Developing countries do not phase out their CFC consumption until 2010 and do not have access to an essential use exemption until that time. Therefore, the Agency’s previous conclusion that there is an oversupply of CFCs was not correct with regard to pharmaceutical-grade CFCs. Because the essential use exemption will not be available to developing countries until 2010, there is a need for developed countries to supply CFCs to meet this demand between 2007 and 2009 under the provisions for basic domestic needs identified in the Montreal Protocol and EPA regulations. The number of facilities that are rated for pharmaceutical-grade CFC production is limited. One company that owns such a facility in the U.S. had previously sourced the developing country demand for pharmaceuticalgrade CFCs from a facility in Europe which, as of 2006, is no longer in operation. Since EPA’s December 29, 2005 final rule set baselines for CFC production for basic domestic needs that are far below the requirements of the Beijing Adjustments, the Agency could allow for a moderate increase in VerDate Aug<31>2005 15:59 Aug 22, 2006 Jkt 208001 the amount of CFC production to meet domestic needs in order to make up the potential shortfall in pharmaceuticalgrade CFC production for developing countries, while still exceeding compliance with the U.S.’s Montreal Protocol obligations. The Montreal Protocol encourages industrial rationalization to minimize the number of sources that produce ozone-depleting substances. The closure of plants in Europe and in developing countries as part of their phase out plans is consistent with this environmental goal. However, EPA recognizes the compelling public health rationale for continued manufacture of certain CFC-containing metered dose inhalers (MDIs). In fact, on April 11, 2006, EPA published a proposed rule in the Federal Register to allow for the manufacture of CFCs for use in metered dose inhalers in the United States for the year 2006, nearly ten years after our phaseout of CFCs (71 FR 18262). Therefore, the Agency is proposing to remove the next phasedown step for companies that manufacture Class I, Group I substances from the phaseout schedule for Article 5 allowances effective January 1, 2007. Since the Agency’s December 29, 2005 final rule established very low baselines for these substances, the U.S. will still exceed compliance with the Beijing Adjustments even without a step-down to 15% of baseline. A step-down to 15% of the baseline established by the Beijing Adjustments (which is based on 1995–1997 export data) would result in an allowable production level of 1,493 metric tons. By comparison, EPA’s proposed approach, which uses the more stringent regulatory baseline based on 2000–2003 export data but maintains the 50% step-down level through 2009, results in an allowable production level of only 173 metric tons. As a result of the action described in this proposed rulemaking, companies that manufacture Class I, Group I substances will have their Article 5 production frozen at the 2006 reduction level of 50% of baseline for the remaining years of the Article 5 reduction schedule, specifically years 2007–2009. EPA reviewed data provided on the volume of pharmaceutical-grade CFCs produced to meet basic domestic needs over the years 2000–2005 and consulted with other governments to confirm whether they did project a need for pharmaceutical-grade CFCs between 2007 and 2009. In removing the next step-down requirement from our domestic regulation, EPA will allow companies to manufacture at their 2006 level, which will be sufficient to meet PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 49397 the need for pharmaceutical-grade CFCs based on the data reviewed by the Agency. III. Statutory and Executive Order Reviews A. Executive Order No. 12866: Regulatory Planning and Review This action is not a ‘‘significant regulatory action’’ under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO. B. Paperwork Reduction Act This proposed action does not impose any new information collection burden. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations, 40 CFR Part 82, 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. A copy of the OMBapproved 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 are listed in 40 CFR Part 9 and 48 CFR Chapter 15. C. Regulatory Flexibility Act EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this proposed rule. For purposes of assessing the impacts of today’s rule on E:\FR\FM\23AUP1.SGM 23AUP1 49398 Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Proposed Rules small entities, small entity is defined as: (1) A small business that is identified by the North American Industry Classification System (NAICS) Code in the Table below; (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 in its field. NAICS code Category 1. Chemical and Allied Products, NEC ................................................................................................... After considering the economic impacts of this proposed rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. This proposed rule will not impose any requirements on small entities, as it regulates large corporations that produce, import, or export Class I controlled substances. There are no small entities in this regulated industry. sroberts on PROD1PC70 with PROPOSALS 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 costeffective, 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 under section 203 of the UMRA a small government agency plan. The plan must VerDate Aug<31>2005 15:59 Aug 22, 2006 Jkt 208001 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. EPA has determined that this proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Thus, today’s rule is not subject to the requirements of sections 202 and 205 of the UMRA. Further, EPA has determined that this proposed rule contains no regulatory requirements that might significantly or uniquely affect small governments because it does not impose any requirements on any State, local, or tribal government. E. Executive Order No. 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. This proposed rule is expected to primarily affect PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 422690 SIC code SIC small business size standard (in number of employees or millions of dollars) 5169 100 producers and exporters of Class I, Group I controlled substances. Thus, Executive Order 13132 does not apply to this proposed rule. F. Executive Order No. 13175: Consultation and Coordination With Indian Tribal Governments Executive Order No. 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 No. 13175, because it does not significantly or uniquely affect the communities of Indian tribal governments. The proposed rule does not impose any enforceable duties on communities of Indian tribal governments. Thus, Executive Order No. 13175 does not apply to this proposed rule. G. Executive Order No. 13045: Protection of Children From Environmental Health & 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 E.O. 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. While this proposed rule is not subject to the Executive Order because it is not economically significant as defined in E.O. 12866, we nonetheless have reason to believe that the E:\FR\FM\23AUP1.SGM 23AUP1 49399 Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Proposed Rules sroberts on PROD1PC70 with PROPOSALS environmental health or safety risk addressed by this action may have a disproportionate effect on children. Depletion of stratospheric ozone results in greater transmission of the sun’s ultraviolet (UV) radiation to the earth’s surface. The following studies describe the effects on children of excessive exposure to UV radiation: (1) Westerdahl J, Olsson H, Ingvar C. ‘‘At what age do sunburn episodes play a crucial role for the development of malignant melanoma,’’ Eur J Cancer 1994; 30A:1647–54; (2) Elwood JM, Jopson J. ‘‘Melanoma and sun exposure: an overview of published studies,’’ Int J Cancer 1997; 73:198–203; (3) Armstrong BK. ‘‘Melanoma: childhood or lifelong sun exposure,’’ In: Grobb JJ, Stern RS, Mackie RM, Weinstock WA, eds. ‘‘Epidemiology, causes and prevention of skin diseases,’’ 1st ed. London, England: Blackwell Science, 1997:63–6; (4) Whiteman D., Green A. ‘‘Melanoma and Sunburn,’’ Cancer Causes Control, 1994; 5:564–72; (5) Kricker A, Armstrong, BK, English, DR, Heenan, PJ. ‘‘Does intermittent sun exposure cause basal cell carcinoma? A case control study in Western Australia,’’ Int J Cancer 1995; 60:489– 94; (6) Gallagher, RP, Hill, GB, Bajdik, CD, et al. ‘‘Sunlight exposure, pigmentary factors, and risk of nonmelanocytic skin cancer I, Basal cell carcinoma,’’ Arch Dermatol 1995; 131:157–63; (7) Armstrong, BK. ‘‘How sun exposure causes skin cancer: an epidemiological perspective,’’ Prevention of Skin Cancer. 2004; 89– 116. Allowing continuing U.S. production to meet developing countries’ basic domestic needs, including their need for pharmaceutical-grade CFCs, avoids the need for those countries to install new ODS manufacturing facilities. The amount of CFCs that will be released to the atmosphere should remain the same regardless of the manufacturing location. In addition, avoiding the installation of new capacity is one means of ensuring that production levels continue to decline. Thus, this proposed rule is not expected to increase the impacts on children’s health from stratospheric ozone depletion. H. Executive Order No. 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This proposed rule is not a ‘‘significant energy action’’ as defined in Executive Order No. 13211, ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355 (May 22, 2001)) because it is not a significant VerDate Aug<31>2005 15:59 Aug 22, 2006 Jkt 208001 regulatory action under Executive Order 12866. I. National Technology Transfer 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. Class I substances in group I (in percent) Control period 2013 .......... 2014 .......... 2015 .......... * * Class I substances in group VI (In percent) 0 0 0 * * 80 80 0 * [FR Doc. E6–13951 Filed 8–22–06; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF TRANSPORTATION Maritime Administration 46 CFR Part 296 [Docket No. MARAD–2006–23804] RIN 2133–AB68 Maintenance and Repair Reimbursement Pilot Program Maritime Administration, DOT. Notice of opening of reply comment period. AGENCY: ACTION: List of Subjects in 40 CFR Part 82 Environmental protection. SUMMARY: The Maritime Administration (MARAD) is amending its regulations governing its pilot program for the Dated: August 17, 2006. reimbursement of costs of qualified Stephen L. Johnson, maintenance and repair (M&R) of Administrator. Maritime Security Program (MSP) 40 CFR part 82 is amended as follows: vessels performed in United States shipyards. Under Public Law 109–163, PART 82—PROTECTION OF the Secretary of Transportation, acting STRATOSPHERIC OZONE through the Maritime Administrator, is 1. The authority citation for part 82 directed to implement regulations that, continues to read as follows: among other things, replace MARAD’s voluntary M&R reimbursement program Authority: 42 U.S.C. 7414, 7601, 7671– with a mandatory system. 7671q. The notice of proposed rulemaking for 2. Section 82.11 is amended by this action was published in the Federal revising paragraph (a)(3) to read as Register on February 8, 2006 (71 FR follows: 6438). Several of the comments received argued that MARAD lacks authority to § 82.11 Exports of Class I controlled substances to Article 5 Parties. unilaterally add to existing MSP agreements the added obligation on the (a) * * * (3) Phased Reduction Schedule for part of the MSP contractor to enter into Article 5 Allowances allocated in an M&R Pilot Program agreement. In § 82.11. For each control period order to have a full airing of this specified in the following table, each fundamental issue, MARAD is hereby person is granted the specified giving notice that we have decided to percentage of the baseline Article 5 open a reply comment period for this allowances apportioned under § 82.11. rulemaking. Reply comments may address the issue highlighted above or Class I subClass I subany other issue raised in the original set Control stances in stances in of comments received in this docket. period group I group VI DATES: Reply comments are due (in percent) (In percent) September 22, 2006. 2006 .......... 50 80 ADDRESSES: You may submit reply 2007 .......... 50 80 2008 .......... 50 80 comments [identified by DOT DMS 2009 .......... 50 80 Docket Number MARAD 2006–23804] 2010 .......... 0 80 by any of the following methods: • Web site: https://dms.dot.gov. 2011 .......... 0 80 2012 .......... 0 80 Follow the instructions for submitting PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\23AUP1.SGM 23AUP1

Agencies

[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Proposed Rules]
[Pages 49395-49399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13951]



[[Page 49395]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2005-0151, FRL-8212-5]
RIN 2060-AK45


Protection of Stratospheric Ozone: Adjusting Allowances for Class 
I Substances for Export to Article 5 Countries

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

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SUMMARY: This proposed action amends previous action by the Agency 
regarding the allocation of Article 5 allowances that permit production 
of ozone-depleting substances (ODS) that are Class I, Group I 
controlled substances solely for export to developing countries to meet 
those countries' basic domestic needs. Specifically, this action will 
remove the 2007-2009 phasedown step for companies that manufacture 
CFCs-11, -12, or -114 for export to meet the basic domestic needs of 
developing countries. The Agency is taking this action in response to 
notification that there would otherwise be a shortfall in the 
availability of pharmaceutical-grade CFCs for use in metered dose 
inhalers in developing countries. In a final rule published December 
29, 2005, EPA established initial baselines for each company that are 
far more stringent than required under the Beijing Adjustments to the 
Montreal Protocol on Substances that Deplete the Ozone Layer (the 
Montreal Protocol), which set out restrictions for production to meet 
basic domestic needs. Therefore, even without the 2007-2009 step-down 
reduction, the U.S. will be at production levels to meet basic domestic 
needs that are far below those allowed under the Beijing Adjustments. 
This action is taken in accordance with the Montreal Protocol and the 
Clean Air Act (CAA).

DATES: Written comments on the rule must be received on or before 
September 22, 2006. Any party requesting a public hearing must notify 
the contact person listed below by 5 p.m. eastern standard time on 
August 28, 2006. If a hearing is requested it will be held on September 
7, 2006 and comments will be due to the Agency October 10, 2006. EPA 
will post information regarding a hearing, if one is requested, on the 
Ozone Protection Web site https://www.epa.gov/ozone. Persons interested 
in attending a public hearing should consult with the contact person 
below regarding the location and time of the hearing.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2005-
0151, by one of the following methods:
     https://www.regulations.gov: follow the on-line 
instructions for submitting comments.
     E-mail: A-and-R-docket@epa.gov.
     Fax: 202-566-1741.
     Mail: Air Docket, Environmental Protection Agency, 
Mailcode: 6102T, 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 B108, Mail 
Code 6102T, Washington, DC 20004. 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-2005-
0151 EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http:/
/www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through www.regulations.gov or e-mail. 
The https://www.regulations.gov Web site is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
www.regulations.gov, your e-mail address will be automatically captured 
and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. For additional information about EPA's public docket visit the 
EPA Docket Center homepage at https://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 B102, 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: Cindy Axinn Newberg, EPA, 
Stratospheric Protection Division, Office of Atmospheric Programs, 
Office of Air and Radiation (6205J), 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460, (202) 343-9729, newberg.cindy@epa.gov.

Table of Contents

I. What Is the Legislative and Regulatory Background of the Phaseout 
Regulations for Ozone-Depleting Substances?
II. Today's Action
III. Statutory and Executive Order Reviews
    A. Executive Order No. 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility
    D. Unfunded Mandates Reform Act
    E. Executive Order No. 13132: Federalism
    F. Executive Order No. 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order No. 13045: Protection of Children From 
Environmental Health & Safety Risks
    H. Executive Order No. 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Congressional Review Act

I. What Is the Legislative and Regulatory Background of the Phaseout 
Regulations for Ozone-Depleting Substances?

    The current regulatory requirements of the Stratospheric Ozone 
Protection Program that limit production and consumption of ozone-
depleting substances (ODSs) can be found at 40 CFR part 82, subpart A. 
The regulatory program was originally published in the Federal Register 
on August 12, 1988 (53 FR 30566), in response to the 1987 signing and 
subsequent ratification of the Montreal Protocol on Substances that 
Deplete the Ozone Layer (Montreal Protocol). The U.S. was one of the 
original signatories to the 1987 Montreal Protocol and the U.S. 
ratified the Protocol on April 21, 1988. Congress

[[Page 49396]]

then enacted, and President Bush signed into law, the Clean Air Act 
Amendments of 1990 (CAAA of 1990), which included Title VI on 
Stratospheric Ozone Protection, codified as 42 U.S.C. Chapter 85, 
Subchapter VI, to ensure that the United States could satisfy its 
obligations under the Montreal Protocol. EPA issued new regulations to 
implement this legislation and has made several amendments to the 
regulations since.
    The requirements contained in the final rules published in the 
Federal Register on December 20, 1994 (59 FR 65478) and May 10, 1995 
(60 FR 24970) establish an Allowance Program. The Allowance Program and 
its history are described in the notice of proposed rulemaking 
published in the Federal Register on November 10, 1994 (59 FR 56276). 
The control and the phaseout of the production and consumption of Class 
I ODSs as required under the Protocol and the CAA are accomplished 
through the Allowance Program.
    In developing the Allowance Program, we collected information on 
the amounts of ODSs produced, imported, exported, transformed and 
destroyed within the U.S. for specific baseline years for specific 
chemicals. This information was used to establish the U.S. production 
and consumption ceilings for these chemicals. The data were also used 
to assign company-specific production and import rights to companies 
that were in most cases producing or importing during the specific year 
of data collection. These production or import rights are called 
``allowances.'' Due to the complete phaseout of many ODSs, the 
quantities of allowances granted to companies for those chemicals were 
gradually reduced and eventually eliminated. Production allowances and 
consumption allowances no longer exist for any ODSs that are Class I 
controlled substances. All production or consumption of Class I 
controlled substances is prohibited under the Montreal Protocol and the 
CAA, except for a few narrow exemptions.
    In the context of the regulatory program, the use of the term 
``consumption'' may be misleading. Consumption does not mean the 
``use'' of a controlled substance, but rather is defined as the 
formula: production + imports-exports, of controlled substances 
(Article 1 of the Protocol and Section 601 of the CAA). Class I 
controlled substances that were produced or imported through the 
expenditure of allowances prior to their phaseout date may continue to 
be used by industry and the public after their phaseout date except 
where the regulations include explicit use restrictions. Use of such 
substances may be subject to other regulatory limitations.
    The specific names and chemical formulas for the Class I controlled 
substances are in Appendix A and Appendix F in Subpart A of 40 CFR Part 
82. The specific names and chemical formulas for the Class II 
controlled substances are in Appendix B and Appendix F in Subpart A.
    Although the regulations phased out the production and consumption 
of Class I controlled substances, a very limited number of exemptions 
exist, consistent with U.S. obligations under the Montreal Protocol. 
The regulations allow for the manufacture of phased-out Class I 
controlled substances provided the substances are either transformed or 
destroyed. They also allow limited manufacture if the substances are 
(1) exported to meet the basic domestic needs of countries operating 
under Article 5 of the Montreal Protocol or (2) produced for essential 
or critical uses as authorized by the Montreal Protocol and the 
regulations. Limited exceptions to the ban on the import of phased-out 
Class I controlled substances also exist if the substances are: (1) 
Previously used, (2) imported for essential or critical uses as 
authorized by the Montreal Protocol and the regulations, (3) imported 
for destruction or transformation only, or (4) a transhipment or (5) a 
heel (a small amount of controlled substance remaining in a container 
after it is discharged or off-loaded) (40 CFR 82.4).
    On December 29, 2005, EPA published a final rule in the Federal 
Register (70 FR 77042) concerning production of specific Class I 
controlled substances for export to meet the basic domestic needs of 
developing countries (``Article 5'' countries). It established a new 
Article 5 allowance baseline for Class I controlled substances, 
established a schedule for phased reductions in such allowances, and 
extended the time allowed for Article 5 production for methyl bromide. 
Article 5 allowances are solely for production to meet the basic 
domestic needs of developing countries referred to in the Protocol as 
``Article 5'' parties. This action amends the schedule for phased 
reductions in Article 5 allowances for companies that produce and 
export Class I, Group I substances to meet the basic domestic needs of 
Article 5 countries.

II. Today's Action

    Under the Montreal Protocol, industrialized countries and 
developing countries have different schedules for phasing out the 
production and import of ODSs. Developing countries operating under 
Article 5, paragraph 1 of the Montreal Protocol in most cases have 
additional time in which to phase out ODSs. The Parties to the Montreal 
Protocol recognized that it would be inadvisable for developing 
countries to spend their scarce resources to build new ODS 
manufacturing facilities to meet their basic domestic needs as 
industrialized countries phase out. The Parties therefore decided to 
permit a small amount of production in industrialized countries, in 
addition to the amounts permitted under those countries' phaseout 
schedules, for export to meet the basic domestic needs of developing 
countries.
    The adjustments to the Montreal Protocol adopted by the Parties at 
their 11th meeting in Beijing required Parties that manufacture ODSs 
for basic domestic needs to establish baselines for such production, 
calculated based on the average quantity of the ODS exported to Article 
5 countries over a specified range of years. The adjustments also 
instituted a reduction schedule for Article 5 manufacture which 
reflects the reduction schedule in place for developing country ODS 
consumption. The Beijing Adjustments underscore the Parties' concern 
that global oversupply of certain Class I ODSs is interfering with the 
transition to alternatives. The oversupply of these ODSs results in low 
prices that make it difficult for non-ozone-depleting alternatives to 
compete in the marketplace. Businesses and individuals thus lack an 
economic incentive to transition to alternatives. The Beijing baseline 
calculation was designed to overcome this problem with respect to 
Article 5 countries by reducing supply to those countries. The price of 
these ODSs should rise to reflect the decrease in supply.
    In response to the Beijing Adjustments, EPA published a final rule 
in the Federal Register on December 29, 2005 (70 FR 77042). The Beijing 
Adjustments to the Protocol, Article 2A, paragraphs 4-7 state that an 
industrialized Party's allowable production of CFCs-11, -12, -113, -
114, and -115, referred to under the Clean Air Act as Class I, Group I 
substances, to meet the basic domestic needs of Article 5 Parties shall 
be measured against ``the annual average of its production of [these 
substances] for basic domestic needs for the period 1995 to 1997 
inclusive.'' EPA's December 29, 2005 action was far more stringent than 
the requirements set forth in Beijing. The Agency established a 
baseline for Class I, Group I substances

[[Page 49397]]

using the more recent export data from the years 2000-2003, years in 
which there were far fewer exports. Therefore, instead of establishing 
an aggregate baseline for Class I, Group I substances of 9,951 metric 
tons--reflecting the 1995-1997 average called for by the Beijing 
Adjustments--EPA's December 29, 2005 final rule established a more 
stringent baseline of 345 metric tons, reflecting export data from 
2000-2003, believing that more recent export data represented a truer 
picture of the actual basic domestic needs for these chemicals in 
developing countries and would thereby address the concerns regarding 
global oversupply of CFCs.
    After publication of the December 29, 2005 final rule, EPA was 
informed that although there is a global oversupply of CFCs in general, 
there are not sufficient supplies of pharmaceutical-grade CFCs 
available for use in metered dose inhalers in developing countries. 
Pharmaceutical-grade CFCs are more pure than a typical batch of CFCs 
and have to meet stringent specifications set out by regulatory 
authorities if they are to be used in medical devices. Developed 
countries like the United States have already reached their phaseout 
date for the production and consumption of CFCs. Under the Montreal 
Protocol, once a Party has reached the phaseout date for CFCs it is 
allowed to apply for an essential use exemption, which permits the 
Party to consume limited amounts of CFCs for essential uses such as 
certain metered dose inhalers. Developing countries do not phase out 
their CFC consumption until 2010 and do not have access to an essential 
use exemption until that time. Therefore, the Agency's previous 
conclusion that there is an oversupply of CFCs was not correct with 
regard to pharmaceutical-grade CFCs. Because the essential use 
exemption will not be available to developing countries until 2010, 
there is a need for developed countries to supply CFCs to meet this 
demand between 2007 and 2009 under the provisions for basic domestic 
needs identified in the Montreal Protocol and EPA regulations.
    The number of facilities that are rated for pharmaceutical-grade 
CFC production is limited. One company that owns such a facility in the 
U.S. had previously sourced the developing country demand for 
pharmaceutical-grade CFCs from a facility in Europe which, as of 2006, 
is no longer in operation. Since EPA's December 29, 2005 final rule set 
baselines for CFC production for basic domestic needs that are far 
below the requirements of the Beijing Adjustments, the Agency could 
allow for a moderate increase in the amount of CFC production to meet 
domestic needs in order to make up the potential shortfall in 
pharmaceutical-grade CFC production for developing countries, while 
still exceeding compliance with the U.S.'s Montreal Protocol 
obligations.
    The Montreal Protocol encourages industrial rationalization to 
minimize the number of sources that produce ozone-depleting substances. 
The closure of plants in Europe and in developing countries as part of 
their phase out plans is consistent with this environmental goal. 
However, EPA recognizes the compelling public health rationale for 
continued manufacture of certain CFC-containing metered dose inhalers 
(MDIs). In fact, on April 11, 2006, EPA published a proposed rule in 
the Federal Register to allow for the manufacture of CFCs for use in 
metered dose inhalers in the United States for the year 2006, nearly 
ten years after our phaseout of CFCs (71 FR 18262).
    Therefore, the Agency is proposing to remove the next phasedown 
step for companies that manufacture Class I, Group I substances from 
the phaseout schedule for Article 5 allowances effective January 1, 
2007. Since the Agency's December 29, 2005 final rule established very 
low baselines for these substances, the U.S. will still exceed 
compliance with the Beijing Adjustments even without a step-down to 15% 
of baseline. A step-down to 15% of the baseline established by the 
Beijing Adjustments (which is based on 1995-1997 export data) would 
result in an allowable production level of 1,493 metric tons. By 
comparison, EPA's proposed approach, which uses the more stringent 
regulatory baseline based on 2000-2003 export data but maintains the 
50% step-down level through 2009, results in an allowable production 
level of only 173 metric tons.
    As a result of the action described in this proposed rulemaking, 
companies that manufacture Class I, Group I substances will have their 
Article 5 production frozen at the 2006 reduction level of 50% of 
baseline for the remaining years of the Article 5 reduction schedule, 
specifically years 2007-2009. EPA reviewed data provided on the volume 
of pharmaceutical-grade CFCs produced to meet basic domestic needs over 
the years 2000-2005 and consulted with other governments to confirm 
whether they did project a need for pharmaceutical-grade CFCs between 
2007 and 2009. In removing the next step-down requirement from our 
domestic regulation, EPA will allow companies to manufacture at their 
2006 level, which will be sufficient to meet the need for 
pharmaceutical-grade CFCs based on the data reviewed by the Agency.

III. Statutory and Executive Order Reviews

A. Executive Order No. 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and 
is therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This proposed action does not impose any new information collection 
burden. However, the Office of Management and Budget (OMB) has 
previously approved the information collection requirements contained 
in the existing regulations, 40 CFR Part 82, 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. 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 are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

C. Regulatory Flexibility Act

    EPA has determined that it is not necessary to prepare a regulatory 
flexibility analysis in connection with this proposed rule. For 
purposes of assessing the impacts of today's rule on

[[Page 49398]]

small entities, small entity is defined as: (1) A small business that 
is identified by the North American Industry Classification System 
(NAICS) Code in the Table below; (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 in its field.

------------------------------------------------------------------------
                                                            SIC small
                                                          business size
                                                          standard (in
            Category                NAICS     SIC code      number of
                                     code                 employees or
                                                           millions of
                                                            dollars)
------------------------------------------------------------------------
1. Chemical and Allied Products,     422690       5169               100
 NEC............................
------------------------------------------------------------------------

    After considering the economic impacts of this proposed rule on 
small entities, EPA has concluded that this action will not have a 
significant economic impact on a substantial number of small entities. 
This proposed rule will not impose any requirements on small entities, 
as it regulates large corporations that produce, import, or export 
Class I controlled substances. There are no small entities in this 
regulated industry.

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 under 
section 203 of the UMRA a small government agency plan. 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.
    EPA has determined that this proposed rule does not contain a 
Federal mandate that may result in expenditures of $100 million or more 
for State, local, and tribal governments, in the aggregate, or the 
private sector in any one year. Thus, today's rule is not subject to 
the requirements of sections 202 and 205 of the UMRA. Further, EPA has 
determined that this proposed rule contains no regulatory requirements 
that might significantly or uniquely affect small governments because 
it does not impose any requirements on any State, local, or tribal 
government.

E. Executive Order No. 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. This proposed rule is expected 
to primarily affect producers and exporters of Class I, Group I 
controlled substances. Thus, Executive Order 13132 does not apply to 
this proposed rule.

F. Executive Order No. 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order No. 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 No. 13175, 
because it does not significantly or uniquely affect the communities of 
Indian tribal governments. The proposed rule does not impose any 
enforceable duties on communities of Indian tribal governments. Thus, 
Executive Order No. 13175 does not apply to this proposed rule.

G. Executive Order No. 13045: Protection of Children From Environmental 
Health & 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 E.O. 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.
    While this proposed rule is not subject to the Executive Order 
because it is not economically significant as defined in E.O. 12866, we 
nonetheless have reason to believe that the

[[Page 49399]]

environmental health or safety risk addressed by this action may have a 
disproportionate effect on children. Depletion of stratospheric ozone 
results in greater transmission of the sun's ultraviolet (UV) radiation 
to the earth's surface. The following studies describe the effects on 
children of excessive exposure to UV radiation: (1) Westerdahl J, 
Olsson H, Ingvar C. ``At what age do sunburn episodes play a crucial 
role for the development of malignant melanoma,'' Eur J Cancer 1994; 
30A:1647-54; (2) Elwood JM, Jopson J. ``Melanoma and sun exposure: an 
overview of published studies,'' Int J Cancer 1997; 73:198-203; (3) 
Armstrong BK. ``Melanoma: childhood or lifelong sun exposure,'' In: 
Grobb JJ, Stern RS, Mackie RM, Weinstock WA, eds. ``Epidemiology, 
causes and prevention of skin diseases,'' 1st ed. London, England: 
Blackwell Science, 1997:63-6; (4) Whiteman D., Green A. ``Melanoma and 
Sunburn,'' Cancer Causes Control, 1994; 5:564-72; (5) Kricker A, 
Armstrong, BK, English, DR, Heenan, PJ. ``Does intermittent sun 
exposure cause basal cell carcinoma? A case control study in Western 
Australia,'' Int J Cancer 1995; 60:489-94; (6) Gallagher, RP, Hill, GB, 
Bajdik, CD, et al. ``Sunlight exposure, pigmentary factors, and risk of 
nonmelanocytic skin cancer I, Basal cell carcinoma,'' Arch Dermatol 
1995; 131:157-63; (7) Armstrong, BK. ``How sun exposure causes skin 
cancer: an epidemiological perspective,'' Prevention of Skin Cancer. 
2004; 89-116.
    Allowing continuing U.S. production to meet developing countries' 
basic domestic needs, including their need for pharmaceutical-grade 
CFCs, avoids the need for those countries to install new ODS 
manufacturing facilities. The amount of CFCs that will be released to 
the atmosphere should remain the same regardless of the manufacturing 
location. In addition, avoiding the installation of new capacity is one 
means of ensuring that production levels continue to decline. Thus, 
this proposed rule is not expected to increase the impacts on 
children's health from stratospheric ozone depletion.

H. Executive Order No. 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This proposed rule is not a ``significant energy action'' as 
defined in Executive Order No. 13211, ``Actions Concerning Regulations 
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355 (May 22, 2001)) because it is not a significant regulatory action 
under Executive Order 12866.

I. National Technology Transfer 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.

List of Subjects in 40 CFR Part 82

    Environmental protection.

    Dated: August 17, 2006.
Stephen L. Johnson,
Administrator.

    40 CFR part 82 is 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.

    2. Section 82.11 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  82.11  Exports of Class I controlled substances to Article 5 
Parties.

    (a) * * *
    (3) Phased Reduction Schedule for Article 5 Allowances allocated in 
Sec.  82.11. For each control period specified in the following table, 
each person is granted the specified percentage of the baseline Article 
5 allowances apportioned under Sec.  82.11.

------------------------------------------------------------------------
                                              Class I         Class I
                                           substances in   substances in
             Control  period               group I  (in    group VI  (In
                                             percent)        percent)
------------------------------------------------------------------------
2006....................................              50              80
2007....................................              50              80
2008....................................              50              80
2009....................................              50              80
2010....................................               0              80
2011....................................               0              80
2012....................................               0              80
2013....................................               0              80
2014....................................               0              80
2015....................................               0               0
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-13951 Filed 8-22-06; 8:45 am]
BILLING CODE 6560-50-P
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