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



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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: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Web site: http://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 
http://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 http://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: [email protected].

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.

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    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

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