[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Rules and Regulations]
[Pages 49836-49844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16809]



[[Page 49835]]

-----------------------------------------------------------------------

Part III





Environmental Protection Agency





-----------------------------------------------------------------------



40 CFR Part 82



Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2005; Final Rule

  Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / 
Rules and Regulations  

[[Page 49836]]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].

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.epa.gov/edocket/ 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.
---------------------------------------------------------------------------

    \1\ ``Consumption'' is defined as the amount of a substance 
produced in the United States, plus the amount imported into the 
United States, minus the amount exported to Parties to the Montreal 
Protocol (see section 601(6) of the Clean Air Act).
    \2\ Class I ozone depleting substances are listed at 40 CFR part 
82, subpart A, appendix A.
---------------------------------------------------------------------------

    However, the 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'' (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 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.

0
40 CFR part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
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

0
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