Protection of Stratospheric Ozone: Supplemental Proposal for the Allocation of Essential Use Allowances for Calendar Year 2005, 8753-8756 [05-3451]

Download as PDF Federal Register / Vol. 70, No. 35 / Wednesday, February 23, 2005 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 82 [FRL–7876–1] RIN 2060–AM50 Protection of Stratospheric Ozone: Supplemental Proposal for the Allocation of Essential Use Allowances for Calendar Year 2005 AGENCY: Environmental Protection Agency (EPA). ACTION: Supplemental notice of proposed rulemaking. SUMMARY: This action supplements EPA’s December 22, 2004, notice of proposed rulemaking (69 FR 76655). In proposing essential use allocations for calendar year 2005, EPA published an incorrect number for the quantity of controlled substances to be allocated to one company, Armstrong Pharmaceuticals. This supplemental proposed rule is being issued to correct the error by increasing Armstrong’s allocation to equal the amount determined by the U.S. Food and Drug Administration (FDA) to be medically necessary in 2005. As a result of this action, the total allocations to all companies would be raised from 1524.58 metric tons, as originally proposed, to 1766.48 metric tons. DATES: Written comments on this proposed rule must be received by the EPA Docket on or before March 25, 2005. ADDRESSES: Submit your comments, identified by Docket ID No. OAR–2004– 0063, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Agency Web site: https:// www.epa.gov/edocket. EDOCKET, EPA’s electronic public docket and comment system, is EPA’s preferred method for receiving comments. Follow the on-line instructions for submitting comments. • Mail: Air and Radiation Docket, Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention: Docket ID No. OAR–2004– 0063. • Hand Delivery: EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC, Attention Docket ID No. OAR– 2004–0063. Deliveries are only accepted during the Docket’s normal hours of operation, and special arrangements should be made for deliveries of boxed information. VerDate jul<14>2003 16:25 Feb 22, 2005 Jkt 205001 Instructions: Direct your comments to Air Docket ID No. OAR–2004–0063. 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.epa.gov/edocket, 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 EDOCKET, regulations.gov, or e-mail. For instructions on how to submit CBI, see ‘‘How do I submit confidential business information to EPA?’’ under SUPPLEMENTARY INFORMATION. The EPA EDOCKET and the federal regulations.gov websites are ‘‘anonymous access’’ systems, 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 EDOCKET or 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 docket are listed in the EDOCKET index at https://www.epa.gov/edocket. Although listed in the index, some information is not publicly available, namely 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 EDOCKET or in hard copy at the Air Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 8753 number for Docket ID No. OAR–2004– 0063 is (202) 566–1742. Materials related to previous EPA actions on the essential use program are contained in EPA Air Docket No. A–93– 39. Docket A–93–39 may be reviewed at the Public Reading Room. FOR FURTHER INFORMATION CONTACT: Scott Monroe, Essential Use Program Manager, 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., Washington, DC 20005, by telephone: 202–343–9712; or by e-mail: monroe.scott@epa.gov. SUPPLEMENTARY INFORMATION: I. What Is the Purpose of This Supplementary NPRM? The purpose of today’s notice is to correct an error in the proposed rule that EPA published in the Federal Register of December 22, 2004 (69 FR 76655). That action proposed to allocate production and import allowances to Armstrong Pharmaceuticals for a quantity of controlled substances in the amount of 29 metric tons. The Food and Drug Administration (FDA), which determines the amount of controlled substances that are medically necessary in each control period, notified EPA via letter after the proposed rule appeared in the Federal Register that the proposed allocation for Armstrong Pharmaceuticals was incorrect (this letter is available in Air Docket OAR– 2004–0063). The proposed amount should have been 270.90 metric tons. EPA is therefore proposing to allocate to Armstrong Pharmaceuticals an additional quantity of production and import allowances in the amount of 241.90 metric tons, which represents the difference between the amount that FDA determined was necessary (270.90 metric tons) and the amount already proposed by EPA (29 metric tons). EPA is not proposing to alter any other company’s allocation, as proposed on December 22, 2004, in today’s action. As a result of the previously published NPRM and today’s supplemental NPRM, the total amount proposed to be allocated to Armstrong Pharmaceuticals for calendar year 2005 is 270.90 metric tons, and consequently the total amount allocated to all companies (including Armstrong) would be increased from 1,524.58 metric tons to 1,766.48 metric tons. The latter amount is less than the total amount, 1,902 metric tons, that was authorized to the United States for 2005 by the Parties to the Montreal Protocol. E:\FR\FM\23FEP1.SGM 23FEP1 8754 Federal Register / Vol. 70, No. 35 / Wednesday, February 23, 2005 / Proposed Rules The reader is referred to the December 22, 2004, NPRM for background information about the essential use program and the process by which EPA and FDA determined the proposed allocations for 2005. II. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether this regulatory action is ‘‘significant’’ and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. The Order defines ‘‘significant regulatory action’’ as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. It has been determined that this action is not a ‘‘significant regulatory action’’ under the terms of Executive Order 12866 and is therefore not subject to OMB review. B. Paperwork Reduction Act This action does not add any information collection requirements or increase burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. OMB previously approved the information collection requirements contained in the final rule promulgated on May 10, 1995, and assigned OMB control number 2060–0170 (EPA ICR No. 1432.21). 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 instruction; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing VerDate jul<14>2003 16:25 Feb 22, 2005 Jkt 205001 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 1. 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 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-forprofit enterprise which is independently owned and operated and is not dominant in 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 rule provides an otherwise unavailable benefit to the company, PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 Armstrong Pharmaceuticals, that is 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 Armstrong Pharmaceuticals. 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 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 phase out of E:\FR\FM\23FEP1.SGM 23FEP1 8755 Federal Register / Vol. 70, No. 35 / Wednesday, February 23, 2005 / Proposed Rules 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. Today’s rule affects only one company that requested essential use allowances. 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 rule affects only one company 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’’ as defined under Executive Order 12866, and (2) concerns an environmental health and 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 that the analysis required under section 5–501 of the Order has the potential to influence the regulation. This rule is not subject to Executive Order 13045 because it implements the phaseout schedule and exemptions established by Congress in Title VI of the Clean Air Act. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The rule affects only one company 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. List of Subjects in 40 CFR Part 82 Administrative practice and procedure, Air pollution control, Chemicals, Chlorofluorocarbons, Environmental protection, Imports, Methyl Chloroform, Ozone, Reporting and recordkeeping requirements. Dated: February 15, 2005. Stephen L. Johnson, Acting 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 ALLOCATION FOR CALENDAR YEAR 2005 Company Quantity (metric tons) Chemical Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease Armstrong Pharmaceuticals ..................................................... Aventis Pharmaceutical Products ............................................. Boehringer Ingelheim Pharmaceuticals .................................... Schering-Plough Corporation ................................................... 3M Pharmaceuticals ................................................................. Wyeth ........................................................................................ VerDate jul<14>2003 16:25 Feb 22, 2005 Jkt 205001 PO 00000 Frm 00005 CFC–11 CFC–11 CFC–11 CFC–11 CFC–11 CFC–11 Fmt 4702 or or or or or or CFC–12 CFC–12 CFC–12 CFC–12 CFC–12 CFC–12 Sfmt 4702 or or or or or or CFC–114 CFC–114 CFC–114 CFC–114 CFC–114 CFC–114 ............................................ ............................................ ............................................ ............................................ ............................................ ............................................ E:\FR\FM\23FEP1.SGM 23FEP1 270.90 57 480 816 69.18 73.40 8756 * * Federal Register / Vol. 70, No. 35 / Wednesday, February 23, 2005 / Proposed Rules * * * [FR Doc. 05–3451 Filed 2–22–05; 8:45 am] BILLING CODE 6560–50–U ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 271 [FRL–7875–6] Mississippi: Final Authorization of State Hazardous Waste Management Program Revisions AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: Mississippi has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant final authorization to Mississippi for RCRA Clusters IV through X. In the ‘‘Rules and Regulations’’ section of this Federal Register, EPA is authorizing the changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we get comments that oppose this action, we will withdraw the immediate final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time. DATES: Send your written comments by March 25, 2005. ADDRESSES: Submit your comments by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • E-mail: middlebrooks.gail@epa.gov. • Fax: (404) 562–8439 (prior to faxing, please notify the EPA contact listed below). • Mail: Send written comments to Gail Middlebrooks at the address listed below. Instructions: Do not submit information that you consider to be CBI or otherwise protected through https:// www.regulations.gov, or e-mail. The Federal regulations.gov Web site is an VerDate jul<14>2003 16:25 Feb 22, 2005 Jkt 205001 ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comments. 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. You can view and copy Mississippi’s applications from 8 a.m. to 4:30 p.m. at the following addresses: Mississippi Department of Environmental Quality, Hazardous Waste Division, 101 W. Capital, Suite 100, Jackson, Mississippi 39201; and EPA, Region 4, Library, 9th Floor, The Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303–3104; (404) 562–8190. FOR FURTHER INFORMATION CONTACT: Gail Middlebrooks, RCRA Services Section, RCRA Programs Branch, Waste Management Division, U.S. Environmental Protection Agency, Region 4, The Sam Nunn Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303–3104; (404) 562– 8494. SUPPLEMENTARY INFORMATION: For additional information, please see the immediate final rule published in the ‘‘Rules and Regulations’’ section of this Federal Register. Dated: February 2, 2005. A. Stanley Meilburg, Acting Regional Administrator, Region 4. [FR Doc. 05–3364 Filed 2–22–05; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Subtitle A [Docket No. OST–2005–20434] Driver’s Licenses and Personal Identification Cards AGENCY: Office of the Secretary (OST), DOT. ACTION: Notice of intent to form a negotiated rulemaking advisory committee. SUMMARY: Pursuant to the portion of the Intelligence Reform and Terrorism Prevention Act of 2004 known as the 9/ 11 Commission Implementation Act of 2004, the Office of the Secretary, DOT, is establishing a committee to develop, through negotiated rulemaking procedures, recommendations for minimum standards to tighten the security for driver’s licenses and personal identification cards issued by PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 States, in order for these documents to qualify for use by Federal agencies for identification purposes. The committee will consist of persons who represent the interests affected by the proposed rule, i.e., State offices that issue driver’s licenses or personal identification cards, elected State officials, the Departments of Transportation and Homeland Security, and other interested parties. The purpose of this document is to invite interested parties to submit comments on the issues to be discussed and the interests and organizations to be considered for representation on the committee. DATES: You should submit your comments or applications for membership or nominations for membership on the negotiated rulemaking committee early enough to ensure that the Department’s Docket Management System (DMS) receives them not later than March 25, 2005. Late-filed comments will be considered to the extent practicable. ADDRESSES: You should mention the docket number of this document in your comments or application/nomination for membership and submit them in writing to: Docket Management System (DMS), Room PL–401, 400 Seventh Street, SW., Washington, DC 20590. Commenters may also submit their comments electronically. Instructions for electronic submission may be found at the following Web address: https:// dms.dot.gov/submit/. You may call the Docket at 202–366– 9324, and visit it from 10 a.m. to 5 p.m., Monday through Friday. Interested persons may view docketed materials on the Internet at any time. Instructions for doing so are found at the end of this notice. You may read the comments received by DMS at the address given above under ADDRESSES. The hours of the Docket are indicated above in the same location. You may also review all documents in the docket via the internet. To read docket materials on the internet, take the following steps: 1. Go to the DMS Web page of the Department of Transportation (https:// dms.dot.gov/). 2. On that page, click on ‘‘search.’’ 3. On the next page (https:// dms.dot.gov/search/), type in the fourdigit docket number shown at the beginning of this document. Example: If the docket number were OST–2005– 1234,’’ you would type ‘‘1234.’’ After typing the docket number, click on ‘‘search.’’ 4. On the next page, which contains docket summary information for the E:\FR\FM\23FEP1.SGM 23FEP1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 35 (Wednesday, February 23, 2005)]
[Proposed Rules]
[Pages 8753-8756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3451]



[[Page 8753]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-7876-1]
RIN 2060-AM50


Protection of Stratospheric Ozone: Supplemental Proposal for the 
Allocation of Essential Use Allowances for Calendar Year 2005

AGENCY: Environmental Protection Agency (EPA).

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: This action supplements EPA's December 22, 2004, notice of 
proposed rulemaking (69 FR 76655). In proposing essential use 
allocations for calendar year 2005, EPA published an incorrect number 
for the quantity of controlled substances to be allocated to one 
company, Armstrong Pharmaceuticals. This supplemental proposed rule is 
being issued to correct the error by increasing Armstrong's allocation 
to equal the amount determined by the U.S. Food and Drug Administration 
(FDA) to be medically necessary in 2005. As a result of this action, 
the total allocations to all companies would be raised from 1524.58 
metric tons, as originally proposed, to 1766.48 metric tons.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before March 25, 2005.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2004-
0063, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Web site: https://www.epa.gov/edocket. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     Mail: Air and Radiation Docket, Environmental Protection 
Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 
20460, Attention: Docket ID No. OAR-2004-0063.
     Hand Delivery: EPA Docket Center, (EPA/DC) EPA West, Room 
B102, 1301 Constitution Ave., NW., Washington, DC, Attention Docket ID 
No. OAR-2004-0063. 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 Air Docket ID No. OAR-2004-
0063. 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.epa.gov/edocket, 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 EDOCKET, 
regulations.gov, or e-mail. For instructions on how to submit CBI, see 
``How do I submit confidential business information to EPA?'' under 
SUPPLEMENTARY INFORMATION.
    The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access'' systems, 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 EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet.
    If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the EDOCKET index 
at https://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, namely 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 EDOCKET or in hard 
copy at the Air Docket, EPA/DC, EPA West, Room B102, 1301 Constitution 
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for Docket ID No. OAR-2004-0063 is (202) 566-1742.
    Materials related to previous EPA actions on the essential use 
program are contained in EPA Air Docket No. A-93-39. Docket A-93-39 may 
be reviewed at the Public Reading Room.

FOR FURTHER INFORMATION CONTACT: Scott Monroe, Essential Use Program 
Manager, 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., Washington, DC 20005, by telephone: 202-343-9712; 
or by e-mail: monroe.scott@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. What Is the Purpose of This Supplementary NPRM?

    The purpose of today's notice is to correct an error in the 
proposed rule that EPA published in the Federal Register of December 
22, 2004 (69 FR 76655). That action proposed to allocate production and 
import allowances to Armstrong Pharmaceuticals for a quantity of 
controlled substances in the amount of 29 metric tons. The Food and 
Drug Administration (FDA), which determines the amount of controlled 
substances that are medically necessary in each control period, 
notified EPA via letter after the proposed rule appeared in the Federal 
Register that the proposed allocation for Armstrong Pharmaceuticals was 
incorrect (this letter is available in Air Docket OAR-2004-0063). The 
proposed amount should have been 270.90 metric tons.
    EPA is therefore proposing to allocate to Armstrong Pharmaceuticals 
an additional quantity of production and import allowances in the 
amount of 241.90 metric tons, which represents the difference between 
the amount that FDA determined was necessary (270.90 metric tons) and 
the amount already proposed by EPA (29 metric tons). EPA is not 
proposing to alter any other company's allocation, as proposed on 
December 22, 2004, in today's action.
    As a result of the previously published NPRM and today's 
supplemental NPRM, the total amount proposed to be allocated to 
Armstrong Pharmaceuticals for calendar year 2005 is 270.90 metric tons, 
and consequently the total amount allocated to all companies (including 
Armstrong) would be increased from 1,524.58 metric tons to 1,766.48 
metric tons. The latter amount is less than the total amount, 1,902 
metric tons, that was authorized to the United States for 2005 by the 
Parties to the Montreal Protocol.

[[Page 8754]]

    The reader is referred to the December 22, 2004, NPRM for 
background information about the essential use program and the process 
by which EPA and FDA determined the proposed allocations for 2005.

II. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether this regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    (1) Have an annual effect on the economy of $100 million or more, 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that this action is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to OMB review.

B. Paperwork Reduction Act

    This action does not add any information collection requirements or 
increase burden under the provisions of the Paperwork Reduction Act, 44 
U.S.C. 3501 et seq. OMB previously approved the information collection 
requirements contained in the final rule promulgated on May 10, 1995, 
and assigned OMB control number 2060-0170 (EPA ICR No. 1432.21).
    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 instruction; 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 1.

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 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 in 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 rule provides an otherwise unavailable benefit to the company, 
Armstrong Pharmaceuticals, that is 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 Armstrong Pharmaceuticals. 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 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 phase out of

[[Page 8755]]

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. Today's rule affects only one 
company that requested essential use allowances. 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 rule affects only one company 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'' 
as defined under Executive Order 12866, and (2) concerns an 
environmental health and 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 that the 
analysis required under section 5-501 of the Order has the potential to 
influence the regulation. This rule is not subject to Executive Order 
13045 because it implements the phaseout schedule and exemptions 
established by Congress in Title VI of the Clean Air Act.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy. The rule affects only one company 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.

List of Subjects in 40 CFR Part 82

    Administrative practice and procedure, Air pollution control, 
Chemicals, Chlorofluorocarbons, Environmental protection, Imports, 
Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

    Dated: February 15, 2005.
Stephen L. Johnson,
Acting 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:


Sec.  82.8  Grant of essential use allowances and critical use 
allowances.

    (a) * * *

        Table I.--Essential Use Allocation for Calendar Year 2005
------------------------------------------------------------------------
                                                        Quantity (metric
             Company                     Chemical             tons)
------------------------------------------------------------------------
 Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and
                  Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals........  CFC-11 or CFC-12 or            270.90
                                    CFC-114.
Aventis Pharmaceutical Products..  CFC-11 or CFC-12 or             57
                                    CFC-114.
Boehringer Ingelheim               CFC-11 or CFC-12 or            480
 Pharmaceuticals.                   CFC-114.
Schering-Plough Corporation......  CFC-11 or CFC-12 or            816
                                    CFC-114.
3M Pharmaceuticals...............  CFC-11 or CFC-12 or             69.18
                                    CFC-114.
Wyeth............................  CFC-11 or CFC-12 or             73.40
                                    CFC-114.
------------------------------------------------------------------------


[[Page 8756]]

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[FR Doc. 05-3451 Filed 2-22-05; 8:45 am]
BILLING CODE 6560-50-U

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