Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2005
[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Rules and Regulations]
[Page 49835-49844]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au05-10]
[[Page 49836]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-7958-2]
RIN 2060-AM50
Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2005
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: With this action, EPA is allocating essential use allowances
for import and production of class I stratospheric ozone depleting
substances (ODSs) for calendar year 2005. Essential use allowances
enable a person to obtain controlled class I ODSs as an exemption to
the regulatory ban of production and import of these chemicals, which
became effective on January 1, 1996. EPA allocates essential use
allowances for exempted production or import of a specific quantity of
class I ODS solely for the designated essential purpose. The
allocations total 1,820.48 metric tons of chlorofluorocarbons for use
in metered dose inhalers.
DATES: This final rule is effective August 19, 2005.
ADDRESSES: Materials related to this rulemaking are contained in EPA
Air Docket OAR-2004-0063. The EPA Air Docket is located at EPA West
Building, Room B102, 1301 Constitution Avenue, NW., Washington, DC,
20460. The Air Docket is open from 8:30 a.m. until 4:30 p.m. Monday
through Friday. Materials related to previous EPA actions on the
essential use program are contained in EPA Air Docket No. A-93-39.
FOR FURTHER INFORMATION CONTACT: Hodayah Finman by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC, 20460; by
telephone: 202-343-9246; by fax: 202-343-2338; or by email:
finman.hodayah@epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. General Information
How Can I Get Copies of Related Information?
II. Basis for Allocating Essential Use Allowances
A. What Are Essential Use Allowances?
B. Under What Authority Does EPA Allocate Essential Use Allowances?
C. What Is the Process for Allocating Essential Use Allowances?
III. Response to Comments
A. EPA Should Not Allocate Essential Use Allowances Generally
B. EPA Should Not Allocate Essential Use Allowances for
Production of Albuterol MDIs
C. Aventis Pharmaceuticals Requested Additional CFCs for 2005
D. Effect of Montreal Protocol Decisions
E. EPA Must Reevaluate FDA's Determinations Regarding Essential
Use Allowance Volumes
F. EPA May Not Allocate Allowances to Companies That Fail to
Demonstrate Research and Development of Alternatives
G. EPA Must Reduce Allocations of Essential Use Allowances by
the Amount That CFC Stockpiles Exceed a One-Year Supply
H. EPA Must Comply With the Act's Requirements for Notice and
Comment Rulemaking
I. The Increase in Armstrong's Proposed Allocation Was Not
Supported by Publicly Available Information
IV. Allocation of Essential Use Allowances for Calendar Year 2005
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Congressional Review Act
VI. Judicial Review
VII. Effective Date of This Final Rule
I. General Information
How Can I Get Copies of Related Information?
1. Docket
EPA has established an official public docket for this action at
Air Docket ID No. OAR-2004-0063. The official public docket consists of
the documents specifically referenced in this action and other
information related to this action. Hard copies of documents related to
previous essential use allocation rulemakings and other actions may be
found in EPA Air Docket ID No. A-93-39. The public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The public docket is
available for viewing at the Air and Radiation Docket in the EPA Docket
Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center 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 Reading Room is (202) 566-1741,
and the telephone number for the Air and Radiation Docket is (202) 566-
1742. EPA may charge a reasonable fee for copying docket materials.
2. Electronic Access
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, ``EPA Dockets.'' You
may use EPA Dockets at http://www.regulations.gov/ to view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket identification number.
II. Basis for Allocating Essential Use Allowances
A. What Are Essential Use Allowances?
Essential use allowances are allowances to produce or import
certain ozone-depleting chemicals in the U.S. for purposes that have
been deemed ``essential'' by the Parties to the Montreal Protocol and
the U.S. Government.
The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol) is an international agreement aimed at reducing and
eliminating the production and consumption \1\ of stratospheric ozone
depleting substances (ODSs). The elimination of production and
consumption of class I ODSs is accomplished through adherence to
phaseout schedules for specific class I ODSs,\2\ including:
chlorofluorocarbons (CFCs), halons, carbon tetrachloride, and methyl
chloroform. As of January 1, 1996, production and import of most class
I ODSs were phased out in developed countries, including the United States.
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\1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported into the
United States, minus the amount exported to Parties to the Montreal
Protocol (see section 601(6) of the Clean Air Act).
\2\ Class I ozone depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
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However, the Protocol and the Clean Air Act (Act) provide
exemptions that allow for the continued import and/or production of
class I ODS for specific uses. Under the Protocol, exemptions may be
granted for uses that are determined by the Parties to be
``essential.'' Decision IV/25, taken by the Parties to the Protocol in
1992, established criteria for determining whether a specific use should be
[[Page 49837]]
approved as essential, and set forth the international process for
making determinations of essentiality. The criteria for an essential
use, as set forth in paragraph 1 of Decision IV/25, are the following:
``(a) That a use of a controlled substance should qualify as
`essential' only if:
(i) It is necessary for the health, safety or is critical for the
functioning of society (encompassing cultural and intellectual
aspects); and
(ii) There are no available technically and economically feasible
alternatives or substitutes that are acceptable from the standpoint of
environment and health;
(b) That production and consumption, if any, of a controlled
substance for essential uses should be permitted only if:
(i) All economically feasible steps have been taken to minimize the
essential use and any associated emission of the controlled substance;
and
(ii) The controlled substance is not available in sufficient
quantity and quality from existing stocks of banked or recycled
controlled substances, also bearing in mind the developing countries'
need for controlled substances.''
B. Under What Authority Does EPA Allocate Essential Use Allowances?
Title VI of the Act implements the Protocol for the United States.
Section 604(d) of the Act authorizes EPA to allow the production of
limited quantities of class I ODSs after the phase out date for the
following essential uses:
(1) Methyl Chloroform, ``solely for use in essential applications
(such as nondestructive testing for metal fatigue and corrosion of
existing airplane engines and airplane parts susceptible to metal
fatigue) for which no safe and effective substitute is available.''
Under the Act, this exemption was available only until January 1, 2005.
Prior to that date, EPA issued methyl chloroform allowances to the U.S.
Space Shuttle and Titan Rocket programs.
(2) Medical Devices (as defined in section 601(8) of the Act), ``if
such authorization is determined by the Commissioner [of the Food and
Drug Administration], in consultation with the Administrator [of EPA]
to be necessary for use in medical devices.'' EPA issues allowances to
manufacturers of metered-dose inhalers (MDIs), which use CFCs as
propellant for the treatment of asthma and chronic obstructive
pulmonary diseases.
(3) Aviation Safety, for which limited quantities of halon-1211,
halon-1301, and halon 2402 may be produced ``if the Administrator of
the Federal Aviation Administration, in consultation with the
Administrator [of EPA] determines that no safe and effective substitute
has been developed and that such authorization is necessary for
aviation safety purposes.'' Neither EPA nor the Parties have ever
granted a request for essential use allowances for halon, because in
most cases alternatives are available and because existing quantities
of this substance are large enough to provide for any needs for which
alternatives have not yet been developed.
The Protocol, under Decision XV/8, additionally allows a general
exemption for laboratory and analytical uses through December 31, 2007.
This exemption is reflected in EPA's regulations at 40 CFR part 82,
subpart A. While the Act does not specifically provide for this
exemption, EPA has determined that an allowance for essential
laboratory and analytical uses is allowable under the Act as a de
minimis exemption. The de minimis exemption is addressed in EPA's final
rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol
subsequently agreed (Decision XI/15) that the general exemption does
not apply to the following uses: testing of oil and grease, and total
petroleum hydrocarbons in water; testing of tar in road-paving
materials; and forensic finger-printing. EPA incorporated this
exclusion at appendix G to subpart A of 40 CFR part 82 on February 11,
2002 (67 FR 6352).
C. What Is the Process for Allocating Essential Use Allowances?
Before EPA will allocate essential use allowances, the Parties to
the Protocol must first approve the United States' request to produce
or import essential class I ODSs. The procedure set out by Decision IV/
25 calls for individual Parties to nominate essential uses and the
total amount of ODSs needed for those essential uses on an annual
basis. The Protocol's Technology and Economic Assessment Panel (TEAP)
evaluates the nominated essential uses and makes recommendations to the
Protocol Parties. The Parties make the final decisions on whether to
approve a Party's essential use nomination at their annual meeting.
This nomination cycle occurs approximately two years before the year in
which the allowances would be in effect. The allowances allocated
through today's action were first nominated by the United States in
January 2003.
Once the U.S. nomination is approved by the Parties, EPA allocates
essential use exemptions to specific entities through notice-and-
comment rulemaking in a manner consistent with the Act. For MDIs, EPA
requests information from manufacturers about the number and type of
MDIs they plan to produce, as well as the amount of CFCs necessary for
production. EPA then forwards the information to the Food and Drug
Administration (FDA), which determines the amount of CFCs necessary for
MDIs in the coming calendar year. Based on FDA's determination, EPA
proposes allocations to each eligible entity. Under the Act and the
Protocol, EPA may allocate essential use allowances in quantities that
together are below or equal to the total amount approved by the
Parties. EPA will not allocate essential use allowances in amounts
higher than the total approved by the Parties. For 2005, the Parties
authorized the United States to allocate up to 1,902 metric tons of
CFCs for essential uses.
EPA published a proposed rule on December 22, 2004 (69 FR 76655)
that would have allocated a total of 1,524.58 metric tons of
allowances. EPA subsequently determined that the amount proposed to be
allocated to one company, Armstrong Pharmaceuticals, was incorrect.
Specifically, EPA had proposed to allocate to Armstrong 29 metric tons,
but the amount should have been 270.90 metric tons. EPA published a
supplemental proposal on February 23, 2005 (70 FR 8753) to correct the
error, which increased the total amount of proposed allowances to
1,766.48 metric tons. Today's rule finalizes both the proposed rule and
the supplemental proposed rule.
III. Response to Comments
EPA received eight sets of comments from six individual commenters
on the proposed rule and the supplemental proposed rule, four of which
were late comments. One commenter objected to the granting of essential
use status generally. One commenter requested additional allowances for
2005. The other four commenters presented arguments related to the
obligations of the United States under the Montreal Protocol and the
requirements of the Clean Air Act with respect to the proposed
allocations. The comments are addressed in more detail below.
A. EPA Should Not Allocate Essential Use Allowances Generally
One commenter opposed exempting Class I substances for any purpose,
including asthma medication, because non-ozone depleting alternatives
have been developed (OAR-2004-0063-0006). EPA disagrees with this
comment. Section 604 of the Act directs
[[Page 49838]]
EPA to authorize production of CFCs for essential MDIs if FDA, in
consultation with EPA, determines such production to be necessary. FDA
has found the use of ozone-depleting substances to be essential in
certain metered dose inhalers for the treatment of asthma and chronic
pulmonary disease (see 21 CFR 2.125(e)). As established by final rule
on July 24, 2002 (67 FR 48370), FDA will determine through rulemaking
when an MDI is no longer essential due to the availability of safe and
effective alternatives.
The same commenter also stated, ``[A]ll of the information these
polluting companies submit should be open to the public.'' The
information submitted was claimed as confidential. That information is
being treated in accordance with EPA's regulations on confidential
business information at 40 CFR 2.201 through 2.311.
B. EPA Should Not Allocate Essential Use Allowances for Production of
Albuterol MDIs
One commenter wrote that EPA should not allocate essential use
allowances for use in CFC albuterol MDIs because they are ``non-
essential'' and the allocations would be ``inconsistent with Decisions
of the Parties to the Montreal Protocol'' (OAR-2004-0063-0012). The
commenter referenced a letter sent by the Natural Resources Defense
Council (NRDC) to EPA on May 13, 2004, that addressed the inclusion of
CFCs for albuterol MDIs in the United States' 2006 essential use
nomination. EPA responded with a letter dated July 12, 2004, in which
we said, ``Until FDA issues a final rule to delist albuterol MDIs (with
an identified effective date) in accordance with its own regulations
and the Administrative Procedures Act, it is premature and contrary to
law for EPA unilaterally to conclude that CFC albuterol MDIs are in
fact no longer essential in the United States and to remove this
essential use from the U.S. nomination for 2006.'' These letters have
been placed in EPA Docket no. OAR-2004-0063. FDA since announced its
decision that CFC albuterol MDIs will no longer be essential after
December 31, 2008 (70 FR 17168, April 4, 2005). Thus, FDA continues to
regard CFC albuterol MDIs as essential for the current control period.
EPA is therefore allocating essential use allowances for CFC albuterol
MDIs in this final rule.
C. Aventis Pharmaceuticals Requested Additional CFCs for 2005
Aventis Pharmaceuticals submitted to the docket a request for
additional allowances in the amount of 60 metric tons, which if
allocated would bring the company's total allocation for 2005 to 117
metric tons. A portion of the additional CFCs would be used for
products exported outside the United States. EPA and FDA considered
this request and determined to grant additional allowances for MDI
products marketed in the United States; the relevant correspondence has
been placed in EPA Docket no. OAR-2004-0063.
EPA is not granting additional allowances to Aventis for production
of CFC MDIs that would be sold outside the United States. Under section
604(d)(2) of the Act, EPA authorizes production of class I substances
``if such authorization is determined by the Commissioner in
consultation with the Administrator, to be necessary for use in medical
devices.'' EPA and FDA have concluded that they currently lack
sufficient information about whether the MDIs in question have been
declared essential in those counties by their public health authority,
whether they could otherwise be considered essential, or whether
production of CFCs for these MDIs is necessary. FDA is thus unable to
render a determination on those issues. Without such determinations,
EPA is not allocating allowances for those MDIs.
Following publication of the proposed rule in the Federal Register
and the request by Aventis for increased allowances, EPA was notified
that Aventis sold certain of its assets related to MDI production to
Inyx USA. Therefore, today's action assigns the allowances proposed for
Aventis, including the additional allowances, to Inyx.
EPA received separate but similar sets of comments from the
International Pharmaceutical Aerosol Consortium (IPAC), NRDC, the U.S.
Stakeholders Group on MDI Transition, and GlaxoSmithKline (GSK), a
pharmaceutical company and member of IPAC. EPA's responses to these
comments are grouped below in accordance with the major points made by
the commenters. In many instances EPA references the GSK comments
because they were both representative of and more detailed than other
comments.
D. Effect of Montreal Protocol Decisions
GSK commented that ``EPA's statutory obligation to fully implement
the provisions of the Montreal Protocol includes decisions by the
Parties to the Protocol'' (OAR-2004-0063-0008, p. 2). EPA previously
discussed the relevance of Decisions of the Parties 69 FR 76984-76985.
Today's action is fully consistent with the Montreal Protocol and the
Decisions of the Parties bolster, rather than detract from, EPA's
interpretation and application of the Protocol's essential use provisions.
E. EPA Must Reevaluate FDA's Determinations Regarding Essential Use
Allowance Volumes
GSK argued that EPA must adhere to Montreal Protocol Decisions and
commented, ``The fact that FDA has recommended [certain allocation]
levels does not absolve EPA from evaluating consistency with Protocol
decisions at the time it makes * * * allocations'' (OAR-2004-0063-0008,
p. 3). GSK also argued that EPA may not rely on the levels authorized
by the Parties to the Protocol, but must reapply relevant Decisions in
its rulemaking process to ensure consistency with the Protocol.
EPA understands today's rulemaking to be fully consistent with the
relevant Protocol Decisions and with its obligations under the Protocol
and Federal law. As explained elsewhere in this section of the
preamble, most of the Decisions cited by GSK specifically reference the
nomination process, not the allocation process. EPA accordingly reviews
those Decisions in preparing the nomination.
F. EPA May Not Allocate Allowances to Companies That Fail To
Demonstrate Research and Development of Alternatives
GSK argued that Decisions VIII/10, XV/5, and IV/25 require EPA to
deny allowances to companies that did not submit research and
development information. GSK stated that it is ``highly likely'' that
not all companies that requested allowances have submitted such
information, and suggested that the U.S. nomination may have been non-
responsive on this point (OAR-2004-0063-0008, p. 8).
EPA disagrees with the commenter's interpretation of Decision VIII/
10 and its effort to establish links between this Decision and others.
Decision VIII/10 provides that Parties ``will request companies
applying for MDI essential-use exemptions to demonstrate ongoing
research and development of alternatives to CFC MDIs with all due
diligence'' as well as to report in confidence on resources and
progress in alternatives development. In accordance with this Decision,
since 1997 EPA has requested applicants to provide this information
when submitting requests for CFC essential use nominations. (67 FR
66148, October 30, 2002). Thus, EPA's interpretation is consistent with
this Decision.
Contrary to GSK's suggestion, Decision VIII/10 does not require any
[[Page 49839]]
action to be taken at the allocation stage. Instead, it states only
that Parties ``will request'' information on research and development
from companies. In addition, Decision VIII/10 does not state how to use
the information. It does not require the United States to report to the
Parties on research and development, either in connection with
essential use nominations or otherwise. Nor does it serve as a basis
for denying an essential use allowance request. See, for example, 67 FR
6355, February 11, 2002.
GSK commented that EPA should not allocate allowances to companies
that do not plan to replace their CFC MDI product with a non-CFC
alternative and are not conducting research to develop new products
(OAR-2004-0063-0008, p. 9). Decision VIII/10, however, does not say
that all applicants must demonstrate ongoing research and development,
regardless of the circumstances. EPA interprets the Parties' intent in
taking Decision VIII/10 to be, as stated on its face, ``to promote
industry's participation on a smooth and efficient transition away from
CFC based MDIs'' generally. Granting allowances for a CFC MDI product,
if the product is listed as essential and production of CFCs is
determined by the Commissioner of FDA to be necessary under section
604(d)(2) of the Act, allows industry and patients to continue to make
and use needed products while non-CFC alternatives are developed. This
is consistent with the Decision VIII/10 standard of ``due diligence.''
Companies may elect to drop their CFC products and withdraw from
the essential use program over time in accordance with their business
plans. EPA has seen at least two instances in which companies--Sciarra
Laboratories and PLIVA--withdrew from the essential use program (by no
longer requesting essential use allowances) without ultimately
reformulating their products in a non-CFC version, leaving the need for
their products to be filled by other essential MDIs or alternatives.
This process is consistent with the goal of promoting a ``smooth and
efficient transition.'' EPA has placed in Docket no. OAR-2004-0063
Federal Register notices from 2001 and 2002 indicating Sciarra's
withdrawal from the program, as well as the Federal Register notice
from 2004 indicating the last year in which PLIVA received allowances
(PLIVA is not included in today's rule). Additionally, EPA has docketed
the U.S. response to Decision XIV/5, sent to the Ozone Secretariat on
February 23, 2005, in which the U.S. identified all CFC and non-CFC
inhalers sold domestically.
GSK stated that ``it is not reasonable to conclude that because a
parent company has presented information to demonstrate its compliance
with Decision VIII/10, that such compliance automatically applies to
that company's subsidiaries. * * * EPA has not provided any information
by which the public can reasonably conclude that Schering-Plough has
shared the fruits of [its] collaboration with its subsidiary, Warrick
Pharmaceuticals'' (OAR-2004-0063-0008, p. 11). GSK also stated that EPA
must deny allocations to Schering for Warrick's product based on
Schering's alleged failure to submit information on Warrick's research
and development efforts. However, as noted above, Decision VIII/10
calls for countries to request information from companies regarding
research and development, and does not speak to the issue of denying
petitions. Furthermore, the decision does not indicate whether the
Parties had any specific intent regarding parent-subsidiary
collaborations. Given the underlying purpose of the Decision to
encourage research and development by the industry as a whole and the
lack of formal corporate distinctions in the Protocol, EPA disagrees
with GSK's construction.
GSK also incorrectly concludes that Decision XV/5 establishes that
``EPA * * * allocations must be assessed for each active ingredient and
each intended market'' (OAR-2004-0063-0008, p. 10). In Decision XV/5,
the Parties agreed: ``To request that Parties * * * when submitting
their nominations for essential-use exemptions for CFCs for metered-
dose inhalers, specify, for each nominated use, the active ingredients,
the intended market for sale or distribution and the quantity of CFCs
required.'' Decision XV/5(2). This Decision refers specifically to the
nomination process. It does not address research and development
reporting, nor does it affect EPA's authority with regard to the
granting of essential use allowances on that ground.
Finally, GSK's citation of Decision IV/25 is also inapposite. GSK
stated that if a company's efforts to research and develop
alternatives, to collaborate with others, and to share such information
with its subsidiaries are ``insufficient,'' then it has not taken ``all
economically feasible steps * * * to minimize the essential use'' in
accordance with Decision IV/25(1)(b)(i) (OAR-2004-0063-0008, pp. 10-
11). EPA disagrees with the commenter's suggestion of a direct
relationship between Decisions IV/25 and VIII/10. Decision VIII/10 does
not make reference to Decision IV/25. Also, GSK's proposed construction
is unreasonable due to the practical difficulties associated with
determining whether an individual company's research and development
efforts constitute ``all economically feasible steps'' for that
company. Such a determination could require detailed knowledge of the
company's financial status and business plans, as well as an
understanding of the economic importance of the company's MDI products
relative to other products manufactured by the company.
Moreover, Paragraph 1(b)(i) of Decision IV/25 speaks to
minimization of particular essential uses, not to general research and
development. EPA has received information from applicants regarding
their efforts to minimize the essential use and associated emissions.
The United States reports to the Parties on these efforts in the annual
essential use nomination. The essential use nomination for 2005 (pp.
12-13), for example, listed several waste minimization strategies
employed in the manufacture of MDIs (see Docket OAR-2004-0063).
Information submitted by individual companies in connection with annual
essential use nominations has been claimed as confidential and is being
treated in accordance with EPA's regulations on confidential business
information a 40 CFR 2.201 through 2.311.
G. EPA Must Reduce Allocations of Essential Use Allowances by the
Amount That CFC Stockpiles Exceed a One-Year Supply
Commenters argued that because Decision XVI/12 states that
countries should pursue ``the objective of maintaining no more than one
year's operational supply [of CFCs],'' and because Decision IV/25
states that production and consumption should be permitted only if
``the controlled substance is not available in sufficient quantity and
quality from existing stocks,'' that EPA must reduce allocations if
stockpiles of CFCs amount to more than a one-year supply. GSK also
argued that section 604(d)(2) of the Clean Air Act reinforces this
requirement by allowing the Administrator to authorize new production
of class I substances for medical devices only if ``such action is
consistent with the Montreal Protocol'' (OAR-2004-0063-0008, p. 13).
EPA believes that this argument misreads the Decisions in question
and that today's action is fully consistent with those Decisions and
the Protocol. At the last Meeting of the Parties in November 2004, the
Parties specifically negotiated and addressed in text the issue of
stockpiles for CFC MDIs. They concluded in Decision XVI/12 that
[[Page 49840]]
``Parties, when preparing essential use nominations for CFCs, should
give due consideration to existing stocks * * * with the objective of
maintaining no more than one year's operational supply.'' First, by its
very terms, the Decision only applies prospectively, when countries
make a nomination, not during any later domestic allocation process.
Second, Decision XVI/12 did not exist at the time of the 2005 U.S.
nomination. The first nomination subject to Decision XVI/12, which the
United States delivered to the Parties on February 2, 2005, stated,
``The USEPA monitors reserves through information provided by companies
that receive essential use allowances. In putting forward our 2007
essential use exemption nomination, the United States carefully
reviewed the size of company reserves, bearing in mind that information
on reserves at the end of 2003 or 2004 is not a reliable indicator of
the amounts that will be held, and their distribution at the beginning
of 2007. Bearing in mind this uncertainty, the United States has given
due consideration to the existence of stocks in accordance with
Decision XVI/12'' (p. 16). Thus, the United States has acted in
conformance with Decision XVI/12.
Third, Decision XVI/12 only sets an objective of a one-year
operational supply. It does not establish an absolute limitation.
Giving ``due consideration'' to the level of stocks at the time of
nomination does not necessarily equate to adjusting the U.S. nomination
if the stockpile data at that point in time indicate a supply greater
than one year's worth. The commenters cited data regarding on-hand CFC
supplies at the beginning of 2004. To the extent the commenters'
concern is based on this data, EPA directs their attention to the more
recent report filed with the Ozone Secretariat on February 23, 2005
(see Docket No. OAR-2004-0063).
GSK noted that Decision XVI/2 expressly references Decision IV/25.
However, Decision IV/25 does not alter the plain meaning of Decision
XVI/12, and indeed it could not, having been decided by the Parties
twelve years before they decided Decision XVI/12. GSK also stated that
Decision IV/25 independently requires EPA to reduce allocations to the
extent that stockpiles are ``excessive.'' This statement assumes that
the Decision's language could only apply to individual Parties, ignores
its hortatory nature, and overlooks the fact that the Parties
specifically chose, in Decision XVI/12, to address the stockpile topic
by setting an ``objective'' and by referring to the nomination, not to
any domestic allocation process.
GSK also referred to Decision XV/5(2), in which the Parties
decided, among other things, ``[t]o request that Parties * * * when
submitting their nominations for essential-use exemptions for CFCs for
metered-dose inhalers, specify, for each nominated use, the active
ingredients * * * and the quantity of CFCs required.'' GSK stated that
the combined effect of Decisions IV/25 and XV/5 is that EPA must,
``[i]n most cases * * * assess stockpiles on a company-specific basis''
(OAR-2004-0063-0008, p. 13). As a consequence, GSK argued, EPA must
consider both available stockpiles in the aggregate and as held by
individual companies. If a single company holds stockpiles greater than
one year's operational supply, then according to the commenter EPA must
reduce the amount of that company's allocation.
GSK has incorrectly interpreted a Decision that explicitly refers
to individual Parties' nominations as referring to individual Parties'
licensing processes. The United States acted in accordance with
Decision XV/5, which was taken in November 2003, by submitting the
requested information in a letter to the TEAP co-chairs (dated April
21, 2004) in connection with the 2006 essential use nomination. The
United States also sent updated information to the TEAP co-chairs on
February 23, 2005, in connection with the 2007 essential use
nomination. Decision XV/5, whether considered alone or together with
Decision IV/25, does not require the United States to take any action
other than to submit the requested information as part of its essential
use nomination. GSK did not explain the assertion that the two
Decisions, taken together, provide more direction than either provides
on its face, nor is there any indication of a direct relationship
between the two Decisions. Decision XV/5 does not make reference to
Decision IV/25. Furthermore, the U.S. nomination for 2005 had already
been submitted at the time the Parties took Decision XV/5 and thus
Decision XV/5 did not apply to that nomination because it post-dated it.
Another commenter quoted the May 2004 TEAP Report (see Docket no.
OAR-2004-0063) to the effect that ``individual companies may hold a
substantial and, perhaps, disproportionate amount'' of a Party's
stockpile (OAR-2004-0063-0011, p. 2). EPA does not agree with this
commenter that the statements in the TEAP report--a document that has
never been formally adopted by the United States--regarding individual
holdings mean that Decision XVI/12 must or should be read as relating
to individual holdings. The TEAP only serves as an advisory body to the
Parties to inform their decision making. It is not a directive body.
Moreover, the natural reading of Decision XVI/12 is that each Party's
objective should be to maintain no more than one year's (aggregate)
supply. Paragraph 3 of that Decision states that ``Parties * * * should
give due consideration to existing stocks * * * with the objective of
maintaining no more than one year's operational supply.'' The
``Parties'' are the subject of the sentence and are thus the entities
to which the phrase ``objective of maintaining no more than one year's
operational supply'' pertains.
H. EPA Must Comply With the Act's Requirements for Notice and Comment
Rulemaking
GSK stated that EPA, in our supplemental proposal to correct
Armstrong's allocation, failed to comply with section 307(d) of the
Act. Section 307(d)(3) directs EPA to make available, among other
items, the factual data on which a proposed rule is based and the
methodology used in obtaining and analyzing those data. GSK stated that
the supplemental proposal was based on information that had not been
placed in the docket, and also that the supplemental proposal was not
justified based on information that EPA had made public. GSK also
stated, ``Even if it were correct that a requesting company has
sufficient information to comment on its own proposed allocation,
neither EPA nor FDA have [sic] provided any basis for a different
interested party to meaningfully comment on that allocation'' (OAR-
2004-0063-0016, p. 3).
As stated above, the information on which FDA, in consultation with
EPA, based the proposed allocations was claimed confidential by the
submitting companies, including Armstrong Pharmaceuticals. As a
consequence, EPA has treated this information in accordance with our
regulations on confidential business information at 40 CFR 2.201
through 2.311. EPA has entered placeholder documents in the public
portion of the docket to indicate the documents that we placed in the
confidential portion.
With respect to the methodology used to determine the proposed
allocations, EPA described the process for allocating essential use
allowances in the preamble to the proposed rule published on December
22, 2004 (69 FR 76657). Section 604(d)(2) of the Act directs the Agency
to authorize production of class I substances ``if such authorization
is determined by the Commissioner, in consultation with the
[[Page 49841]]
Administrator, to be necessary for use in medical devices.'' EPA
entered the Acting Commissioner's letter of determination (OAR-2004-
0063-0005), as well as the FDA's subsequent letter of correction (OAR-
2004-0063-0010), into the public docket for comment. EPA also explained
in the preamble of the supplemental proposal that the allocation
originally proposed for Armstrong Pharmaceuticals was based on an
error, and the purpose of the supplemental notice was to correct the
error. Portions of the correspondence regarding the nature of the error
have been placed in the confidential portion of the docket due to
concerns regarding disclosure of information claimed as confidential. A
placeholder has been entered in the public portion of the docket with
respect to this information.
EPA thus has made public the most information possible given our
obligations regarding the treatment of information claimed as
confidential. Therefore, EPA has acted in accordance with section
307(d) of the Act with respect to making public the basis and
methodology for our proposed allocations. EPA has also acted in
accordance with section 604(d)(2) of the Act. EPA does not have
discretion to refuse to authorize production that is consistent with
the Montreal Protocol and that has been determined to be necessary by
FDA in consultation with EPA.
I. The Increase in Armstrong's Proposed Allocation Was Not Supported by
Publicly Available Information
GSK stated that the corrected allocation proposed for Armstrong
Pharmaceuticals in the supplemental notice was too high and ``cannot be
supported under the CAA or the Montreal Protocol'' (OAR-2004-0063-0016,
p. 6). This commenter argued that Armstrong's actual MDI production in
recent years, according to publicly available data, was far less than
would warrant the amount of CFC production allowances that Armstrong
would receive according to the supplemental proposed rule. Also, GSK
stated that Armstrong ``must be holding huge stockpiles of CFCs--at
least sufficient to supply its production for more than a year,'' and
that by allocating additional allowances to Armstrong in 2005 EPA would
violate the terms of the Montreal Protocol (OAR-2004-0063-0016, p. 5).
Because Armstrong has claimed its 2005 essential use allowance
documentation as confidential, EPA is unable to respond to the points
made by the commenter specifically with regard to Armstrong's proposed
allocation. However, GSK made several assumptions that EPA may respond
to in general terms. First, GSK assumed that a company uses all of the
allowances it is allocated in a given year. This is not the case, as
evidenced by the U.S. Accounting Framework, which since 2001 has shown
that the amount authorized has consistently exceeded the amount
actually acquired (Accounting Frameworks for 2001-2004 have been placed
in Docket no. OAR-2004-0063). In the 2004 Accounting Framework, for
example, the United States reported 964 metric tons of CFCs authorized
but not acquired. This fact reflects an important aspect of the
essential use program: Both the U.S. nomination and the subsequent
allocation rule issued for a given year involve projections, and there
is unavoidably some uncertainty associated with projections of demand
for CFC MDIs. In the interest of ensuring public access to essential
MDIs, EPA believes it is safer for public health to risk allocating
more allowances than may be used than to allocate too few and risk a
shortage.
Second, GSK assumed that a company would be able to generate a
large stockpile of essential use CFCs by using all of its allowances to
produce or import CFCs without actually using those CFCs to manufacture
MDIs during the same control period. However, a company engaging in
this practice would reveal itself in its reporting to EPA in accordance
with regulations at 40 CFR 82.13(u). EPA's examination of the data from
this reporting has led it to conclude that stocks are on a downward
trend in recent years. EPA expects companies to manage their allowances
in good faith consistent with the goals of the essential use program.
The proposition that any company has accrued stores of essential
use CFCs many times in excess of its annual usage is contradicted by
the Accounting Framework. Since 2001, the amount of CFCs that the
United States reported to the Ozone Secretariat as on-hand at the end
of the year (Column L of the Accounting Framework) has decreased every
year, from 1,910 metric tons in 2001 to 1,521 metric tons in 2004.
Excessive stockpiling of CFCs by one or more companies would be
reflected in the Accounting Framework as an increase in on-hand CFCs.
Third, the commenter assumed that a company's allocations must be
based on the company's prior record of production. If a company's
projected need for CFCs is higher than past usage, the commenter
suggests, then EPA should not authorize additional CFCs. It is true
that a company's prior usage of CFCs is relevant to EPA's proposed
allocations, which is why EPA's February 24, 2004, letter to MDI
manufacturers required them to include in their essential use
applications prior-year production data (OAR-2004-0063-0002).
Nevertheless, past production alone is an insufficient basis for
allocating allowances in light of the fact that market conditions may
change, and a company may increase or decrease its levels of production
accordingly. Thus, EPA's February 24, 2004, letter also requested
information regarding anticipated needs during 2005. For this reason
and the other reasons explained above, EPA disagrees with the
conclusions reached by the commenter with regard to the proposed
allocation for Armstrong.
IV. Allocation of Essential Use Allowances for Calendar Year 2005
With today's action, EPA is allocating essential use allowances for
calendar year 2005 to the entities listed in Table 1. These allowances
are for the production or import of the specified quantity of class I
controlled substances solely for the specified essential use.
Table I.--Essential Use Allocation for Calendar Year 2005
------------------------------------------------------------------------
Quantity
Company Chemical (metric 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.
Boehringer Ingelheim CFC-11 or CFC-12 or 480
Pharmaceuticals. CFC-114.
Inyx USA, Ltd.\3\................ CFC-11 or CFC-12 or 111
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.
[[Page 49842]]
Wyeth Pharmaceuticals............ CFC-11 or CFC-12 or 73.40
CFC-114.
------------------------------------------------------------------------
V. 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:
---------------------------------------------------------------------------
\3\ As explained in section III.C of the preamble, allowances
allocated to Aventis in the proposed rule are being allocated to
Inyx in today's final rule.
---------------------------------------------------------------------------
(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.
Pursuant to the terms of Executive Order 12866, it has been
determined that this regulatory action is a ``significant regulatory
action'' because it raises novel legal or policy issues. As such, this
action was submitted to OMB for Executive Order 12866 review. Changes
made in response to OMB suggestions or recommendations will be
documented in the public record.
Under section 6(a)(3)(B)(ii) of Executive Order 12866, the Agency
must provide to OMB's Office of Information and Regulatory Affairs an
``assessment of the potential costs and benefits of the regulatory
action, including an explanation of the manner in which the regulatory
action is consistent with a statutory mandate and, to the extent
permitted by law, promotes the President's priorities and avoids undue
interference with State, local, and tribal governments in the exercise
of their governmental functions.''
EPA is undertaking today's final action under the mandate
established by section 604(d) of the Clean Air Act Amendments of 1990,
which directs the Administrator to authorize the production of limited
quantities of class I substances solely for use in medical devices, if
the Commissioner of FDA determines that the authorization is necessary.
The final allocations in today's rule are the amounts determined by FDA
to be necessary for calendar year 2005.
EPA has not assessed the costs and benefits specific to today's
final action. The Agency examined the costs and benefits associated
with a related regulation. The Agency's Regulatory Impact Analysis
(RIA) for the entire Title VI phaseout program examined the projected
economic costs of a complete phaseout of consumption of ozone-depleting
substances, as well as the projected benefits of phased reductions in
total emissions of CFCs and other ozone-depleting substances, including
essential-use CFCs used for metered-dose inhalers (U.S. Environmental
Protection Agency, ``Regulatory Impact Analysis: Compliance with
section 604 of the Clean Air Act for the Phaseout of Ozone Depleting
Chemicals,'' July 1992).
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
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this final rule. EPA has also
determined that this rule will not have a significant economic impact
on a substantial number of small entities. For purposes of assessing
the impact of today's rule on small entities, small entities are
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 that is independently owned and operated and is not dominant
in its field.
After considering the economic impacts of today's final rule on
small entities, EPA has concluded 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 proposed rule on small entities.'' 5 U.S.C. 603
and 604. Thus, an agency may conclude 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 those companies that
are receiving essential use
[[Page 49843]]
allowances. We have therefore concluded that today's final rule will
relieve regulatory burden for all small entities.
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 phaseout of class I ODSs. Similarly, EPA has determined
that this rule contains no regulatory requirements that might
significantly or uniquely affect small governments, because this rule
merely allocates essential use exemptions to entities as an exemption
to the ban on production and import of class I ODSs.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this rule.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (59 FR 22951, 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 final rule does not have
tribal implications, as specified in Executive Order 13175. Today's
rule affects only the companies that requested essential use
allowances. Thus, Executive Order 13175 does not apply to this rule.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies
to any rule that (1) is determined to be ``economically significant''
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 the
pharmaceutical companies that requested essential use allowances.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in this
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
final rule does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.
J. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Therefore, EPA will submit a report containing this rule
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller
[[Page 49844]]
General of the United States prior to publication of the rule in the
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2). This rule will be effective August 19, 2005.
VI. Judicial Review
Under section 307(b)(1) of the Act, EPA finds that these
regulations are of national applicability. Accordingly, judicial review
of the action is available only by the filing of a petition for review
in the United States Court of Appeals for the District of Columbia
Circuit within sixty days of publication of the action in the Federal
Register. Under section 307(b)(2), the requirements of this rule may
not be challenged later in judicial proceedings brought to enforce
those requirements.
VII. Effective Date of This Final Rule
Section 553(d) of the Administrative Procedures Act (APA) generally
provides that rules may not take effect earlier than 30 days after they
are published in the Federal Register. Today's final rule is issued
under section 307(d) of the CAA, which states, ``The provisions of
section 553 through 557 * * * of Title 5 shall not, except as expressly
provided in this subsection, apply to actions to which this subsection
applies.'' Thus, section 553(d) of the APA does not apply to this rule.
EPA nevertheless is acting consistently with the policies underlying
APA section 553(d) in making this rule effective August 19, 2005. APA
section 553(d) provides an exception for any action that grants or
recognizes an exemption or relieves a restriction. Because today's
action grants an exemption to the phaseout of production and
consumption of CFCs, EPA is making this action effective immediately to
ensure continued availability of CFCs for medical devices.
List of Subjects in 40 CFR Part 82
Administrative practice and procedure, Air pollution control,
Chemicals, Environmental protection, Exports, Imports, Reporting and
recordkeeping requirements.
Dated: August 17, 2005.
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.
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 and critical use allowances.
(a) * * *
Table I.--Essential Use Allocation for Calendar Year 2005
------------------------------------------------------------------------
Quantity
Company Chemical (metric 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.
Boehringer Ingelheim CFC-11 or CFC-12 or 480
Pharmaceuticals. CFC-114.
Inyx USA, Ltd.................... CFC-11 or CFC-12 or 111
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 Pharmaceuticals............ CFC-11 or CFC-12 or 73.40
CFC-114.
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-16809 Filed 8-23-05; 8:45 am]
BILLING CODE 6560-50-P