Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2001: Allocation for Metered Dose Inhalers and the Space Shuttle and Titan Rockets

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Other Related Documents

[Federal Register: January 8, 2001 (Volume 66, Number 5)]
[Rules and Regulations]
[Page 1461-1471]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ja01-11]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6929-6]
RIN 2060-AJ33

Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2001: Allocation for Metered Dose Inhalers
and the Space Shuttle and Titan Rockets

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: With this action, EPA is allocating essential use allowances
for stratospheric ozone depleting substances for calendar year 2001.
EPA allocates essential use allowances to an applicant for exempted
production or import of a specific quantity of class I ozone depleting
substances solely for the designated essential use. Essential use
allowances permit a person to obtain controlled substances as an
exemption to the January 1, 1996 regulatory phase-out of production and
import of these substances. Today, EPA is allocating essential use
allowances for the production and/or import of class I substances for
use in medical devices for the treatment of asthma and chronic
obstructive pulmonary disease, and for use in the Space Shuttle and
Titan Rockets for calendar year 2001. With today's action, EPA is also
amending the regulations to allow essential use allowances for medical
devices to be transferred among essential use allowance holders. The
essential use exemption for class I ODSs for laboratory and analytical
applications will be addressed in a separate rulemaking.

DATES: This action is effective January 8, 2001.

ADDRESSES: Materials relevant to this rulemaking are contained in
Docket No. A-93-39. The Docket phone is (202) 260-7548 and is located
in Waterside Mall, Room M-1500, 401 M Street, SW., Washington, DC,
20460. The materials may be inspected from 8 a.m. until 5:30 p.m.
Monday through Friday. A reasonable fee may be charged by EPA for
copying docket materials.

FOR FURTHER INFORMATION CONTACT: The Stratospheric Ozone Protection
Hotline at 1-800-296-1996 or Erin Birgfeld, U.S. Environmental
Protection Agency, Global Programs Division, Office of Atmospheric
Programs, 6205J, 1200 Pennsylvania Avenue N.W., Washington, DC, 20460;
telephone (202) 564-9079; fax: (202) 565-2095; email:
birgfeld.erin@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Allocation Process for CFCs for use in Medical Devices for the
Year 2001
III. Allocation of Essential Use Allowances for Calendar Year 2001
IV. Transfer of Essential Use Allowances for CFCs Among Essential
Use Allowance Holders
V. Administrative Requirements
VI. Judicial Review
VII. Submittal to Congress and the General Accounting Office

I. Background

The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol) is the international agreement to reduce and eventually
eliminate production and consumption\1\ of all stratospheric ozone
depleting substances (ODSs). As of January 1996, production and import
of class I ODSs (except methyl bromide) were phased out in all
developed countries, including the United States. However, the Protocol
and the Clean Air Act (CAA or Act) provide exemptions that allow for
the continued import and/or production of class I ODSs for specific
uses. Under the Montreal Protocol, exemptions are granted for uses that
are determined by the Parties to be ``essential'' as defined by
Decision IV/25. The procedure set out by Decision IV/25 first calls for
individual Parties to nominate essential uses. The Protocol's
Technology and Economic Assessment Panel (TEAP or the Panel) evaluates
the nominated essential uses and makes recommendations to the Protocol
Parties. The Parties make the final decisions on essential use
nominations at their annual meeting.
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\1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported, minus the
amount exported to Parties to the Montreal Protocol (see section
601(6) of the Clean Air Act). Stockpiles of class I ODSs produced
prior to the 1996 phase-out can continue to be used for purposes not
expressly banned at 40 CFR part 82, subpart C--Ban on Nonessential
Products Containing Class I Substances and Ban on Nonessential
Products Containing or Manufactured with Class II Substances.
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EPA is responsible for allocating essential use allowances (EUAs)
at the domestic level through rulemaking in accordance with provisions
in the CAA. The CAA provides a specific exemption from the phase-out of
class I ODSs at section 604(d)(2) that allows for the continued import
and production of CFCs for use in medical devices. Today's action
allocates EUAs for CFCs for use in metered dose inhalers (MDIs) for the
treatment of asthma and chronic obstructive pulmonary disease (COPD)
for calendar year 2001. EPA is also allocating methyl chloroform for
use in the Space Shuttle and the Titan Rocket for calendar year 2001
under the authority of the statutory phase-out at section 604(a).
Today's action also amends the regulations at 40 CFR 82.12 to allow
transfer of EUAs for CFCs among MDI companies who hold essential use
allowances.

Overview of the Notice of Proposed Rulemaking

The Notice of Proposed Rulemaking (NPRM) proposing to allocate
essential use allowances for calendar year 2001 was published on
October 6, 2000 (65 FR 59783). In the NPRM, EPA proposed to allocate
CFCs for use in metered dose inhalers (MDIs) and methyl chloroform for
use in the Space Shuttle and Titan Rocket. EPA proposed to allocate a
total of 3098.67 metric tons of CFCs, which is the quantity that the
Food and Drug Administration (FDA), in consultation with EPA,
determined to be ``necessary'' for use in MDIs. The total amount of
essential use authorizations for MDIs granted to the U.S. by the
Parties to the Montreal Protocol for 2001 is 3,101 metric tons. We
explained in the NPRM that it would not be possible to allocate CFCs in
an amount higher than allocated to the U.S. by the Parties to the
Protocol. EPA also proposed changes to the regulations at 40 CFR 82.12
that would allow transfer of EUAs for CFCs among essential use holders.
We also proposed to allocate 60.1 metric tons of methyl chloroform
(MCF) for use in the Space Shuttle and Titan Rockets.
EPA received a total of eight comments on the NPRM. Six comments
were from individual companies who produce MDIs,\2\ one was from a
consortium group that represents MDI manufacturers,\3\ and one was from
Friends of the Earth. Three commenters expressed support for the
provision to allow transfer of EUAs for CFCs between allowance holders.
One commenter requested additional EUAs to meet their projected needs
for MDI production in 2001 without utilizing their strategic reserves.
Two companies requested that their EUAs be reapportioned between them,
but in the aggregate did not request an increase in EUAs. One commenter
stated that EPA and FDA had improperly interpreted the

[[Page 1463]]

exemption for medical devices in the Act, and should not allocate CFCs
for MDI products where an alternative propellant is available. Another
commenter stated that the Act does not require EPA to transfer to FDA
the responsibility to determine the amount of the allocation for CFCs,
and that the FDA decision making process for determining the amount of
CFCs necessary should be more transparent. EPA will summarize and
address all comments in the body of this preamble. There were no
comments on the proposed allocation of MCF for use in the Space Shuttle
and Titan Rockets.
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\2\ Pharmaceutical companies who commented were the following:
Aventis Pharmaceuticals, 3M Pharmaceuticals, Boehringer Ingelheim
Pharmaceuticals Inc., Schering Corporation, Sidmak Laboratories
Inc., Glaxo Wellcome.
\3\ The International Pharmaceutical Aerosol Consortium
represents the following companies: AstraZeneca, Boehringer
Ingelheim, Celltech-Medeva, Cheisi Farmaceutici, Glaxo Wellcome, and
Norton Healthcare.
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How Do the Parties to the Montreal Protocol Define an ``Essential
Use''?

Decision IV/25 of the Parties to the Montreal Protocol set forth
the criteria for determining whether a particular use of class I ODS is
``essential'' and would thus be eligible to receive EUAs for controlled
substances. This decision states the following:
``(1) 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;
(2) 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.''

What Was the International Procedure for Approving Essential Use
Exemptions for the Year 2001?

The international process for nominating and approving essential
use allowances for the year 2001 occurred in the same way as in prior
years. The companies in Table I submitted applications either on their
own or as a part of the International Pharmaceutical Aerosol Consortium
(IPAC), requesting class I ODSs for essential uses in response to the
August 10, 1998 Federal Register document (63 FR 42629). Their
applications requested exemptions for the production and import of
specific quantities of certain class I controlled substances after the
phase-out, and provided information in accordance with the criteria in
Decision IV/25 of the Protocol and the procedures outlined in the
``1997 Handbook on Essential Use Nominations.'' EPA reviewed the
applications and nominated these uses to the Protocol Secretariat for
consideration by the Technical and Economic Assessment Panel (TEAP) and
its Technical Options Committees. MDI producers requested a total of
3,101 metric tons of CFCs for use in 2001. The Parties to the Montreal
Protocol approved this amount as essential for the U.S. for 2001 at the
Eleventh Meeting in 1999 (Decision XI/14). On September 15, 1999, EPA
issued another notice requesting supplemental applications for
essential use allowances for the year 2001 and beyond (64 FR 50083). No
company requested a supplemental amount of CFCs for the year 2001 at
that time.

How Does the Clean Air Act Authorize Essential Use Allowances for MDIs?

Section 604(d)(2) of the CAA provides a standing exemption to the
phase-out of class I ODSs for the production and importation of CFCs
for use in medical devices which reads:

``Notwithstanding the termination of production required by
subsection (b), the Administrator, after notice and opportunity for
public comment, shall, to the extent such action is consistent with
the Montreal Protocol, authorize the production of limited
quantities of class I substances solely for use in medical devices
if such authorization is determined by the Commissioner, in
consultation with the Administrator, to be necessary for use in
medical devices.''

Section 601(8) of the Clean Air Act defines the term ``medical
device'' and states the following:

[A]ny device (as defined in the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321), diagnostic product, drug (as defined in the Federal
Food, Drug, and Cosmetic Act), and drug delivery system--
(A) if such device, product, drug, or drug delivery system utilizes
a class I or class II substance for which no safe and effective
alternative has been developed, and where necessary, approved by the
Commissioner [of FDA]; and
(B) if such device, product, drug, or drug delivery system, has,
after notice and opportunity for public comment, been approved and
determined to be essential by the Commissioner [of FDA] in
consultation with the Administrator [of EPA].

As discussed in the NPRM, EPA is relying on FDA regulations at 21
CFR 2.125 to provide determinations of whether a ``safe and effective
alternative'' is available for any particular CFC MDI. It should be
noted that FDA approval of a non-CFC product is a determination that
the product is safe and effective, but it is not a determination that
the product is a ``safe and effective alternative'' for any other CFC
MDI product under the Act. FDA states in their notice of proposed
rulemaking on essential use determinations that ``a non-CFC product
simply having the same active moiety as a CFC product is only one
factor to be considered. Other factors, such as whether the non-CFC
product has the same route of administration, the same indication, and
can be used with approximately the same level of convenience, are
important considerations. Additionally, FDA must consider whether
patients who medically need the CFC product are adequately served by
the non-CFC product.'' (September 1, 1999, 64 FR 47735). While FDA has
approved two non-CFC MDIs as of December 1, 2000, FDA has yet not
identified any ``safe and effective alternative'' to any CFC MDI as
specified by section 601(8)(A). Thus, part (A) of the definition of
medical device has been met, and is consistent with today's rulemaking.
With respect to section 601(8)(B), EPA is relying on current FDA
regulations (21 CFR 2.125) listing medical devices that FDA has found
to be essential. The companies for which EPA is granting essential use
allowances produce CFC MDIs covered by this regulation. Thus, the
products for which EPA is granting essential use allowances are
``determined to be essential'' by FDA.
One commenter stated that under section 601(8)(A), EPA must
determine that no safe and effective alternative propellant exists for
any MDI to meet the definition of ``medical device.'' EPA believes that
the phrase ``safe and effective alternative'' at section 608(1)(A) does
not refer an alternative propellant, but refers to a ``safe and
effective alternative'' to a CFC MDI. This is because FDA only approves
MDIs under a New Drug Application (NDA) or an Abbreviated New Drug
Application (ANDA) as a whole unit and not by approving each of its
components. Therefore, it is impossible for FDA to approve an
alternative to the class I or class II substance (i.e. the propellant)
alone, and it is reasonable to conclude that the phrase ``safe and
effective alternative'' refers to an adequate replacement for the CFC
MDI product.
This commenter also quoted a passage from the legislative history
of the 1990 Amendments which states that ``unless a safe substitute
exists or until a

[[Page 1464]]

substitute is developed and approved by FDA, a drug delivery system may
be found by the Commissioner and the Administrator to be essential''
(S. Rep No. 228, 101st Cong., 1st Sess. 1989, 1990). The commenter
believes that this passage supports their belief that once a drug
containing a safe and effective alternative propellant has been
approved by FDA, FDA has no authority to continue to designate
analogous CFC-containing products as ``essential''. In response, we
note that the term ``drug delivery system'' indicates that Congress
envisioned that FDA would need to approve an entire non-CFC drug
delivery system, and not just the alternative propellant. Further, the
use of the term ``substitute'' indicates that Congress was looking to
FDA to determine whether a non-CFC MDI is a safe and effective
replacement for a particular CFC MDI (i.e. a ``safe and effective
alternative''). While this report refers to Senate language which is
somewhat different from what appears in the 1990 Amendments, the
Senate's intent, revealed by this passage is consistent with EPA and
FDA's interpretation of the Act.
The commenter also states that the safety and efficacy of
alternatives to CFCs is determined by EPA under section 612 of the CAA,
and that EPA had stated that it would rely upon FDA's approval of
medical products containing alternative propellants under the Food Drug
and Cosmetic Act (FDCA) for a determination that there are no human
health effects from the use of the alternative propellant. Thus, the
commenter believes that when FDA approves a non-CFC MDI as safe and
effective under the FDCA, EPA must conclude that the non-CFC propellant
in that product is safe and effective for the purposes of the CAA. In
fact, EPA has already reviewed the health risks associated with
alternative aerosol propellants for use in non-CFC MDIs under section
612 of the Act. Nevertheless, EPA disagrees with the assertion that a
determination that an alternative propellant to an ODS is acceptable
under section 612 of the Act has any bearing on the determination of
whether a non-CFC MDI is a ``safe and effective alternative'' to a CFC
MDI as required by section 601(8)(A).
The commenter states that when a non-CFC MDI is approved under the
FDCA, only CFC-based products containing the same active moiety, and
the same labeled indications would no longer qualify as ``medical
devices'' under the Act, and that in instances where the labeled
indications of a non-CFC drug do not fully duplicate those of a CFC
product, EPA may only authorize production of limited quantities of
CFCs that the EUA applicant demonstrates are necessary to serve
patients not covered by the non-CFC drug product's indications. EPA
believes that the commenter is wrong to assert that because a safe and
effective non-CFC MDI is available, EPA should deem CFC MDIs with the
same active moiety to be non-essential for the purposes of the CAA. As
stated earlier, FDA approval of a non-CFC product is a determination
that the product is safe and effective, but it is not a determination
that the product is a safe and effective alternative for any other
product under the Act. Because FDA has yet not identified any ``safe
and effective alternative'' for any CFC MDI, today's allocation of CFCs
for essential uses remains consistent with section 601(8)(A).
The commenter's suggestion that EPA make medical decisions
regarding whether a non-CFC MDI is an adequate alternative to a CFC MDI
produces a result that would put asthma patient health at risk. FDA is
the appropriate agency with expertise to make independent medical
decisions that directly affect patients. The determination that a CFC
MDI is no longer ``essential'' is not, as the commenter suggests, one
where EPA could merely look at the active moiety of the product, read
the non-CFC product indication, compare it to the CFC MDI product
indication, and determine any CFC MDIs to be non-essential. FDA states
in their notice of proposed rulemaking on essential use determinations
that ``a non-CFC product simply having the same active moiety as a CFC
product is only one factor to be considered. Other factors, such as
whether the non-CFC product has the same route of administration, the
same indication, and can be used with approximately the same level of
convenience, are important considerations. Additionally, FDA must
consider whether patients who medically need the CFC product are
adequately served by the non-CFC product.'' (September 1, 1999, 64 FR
47735). Most of these factors are not addressed on the indication label
of an MDI. Thus the indication label alone cannot be used as the basis
for determining whether a non-CFC product is an adequate alternative
for any CFC MDI.
We believe that the overall purpose of the language in the Act
regarding medical devices is to ensure that EPA's mission of
environmental protection does not conflict with FDA's mission of
protecting the patient health. Consistent with this purpose, we believe
that in drafting the definition, Congress was focusing on the
availability of adequate alternative medical treatment for patients who
rely on CFC MDIs. EPA is not the appropriate agency to decide whether
such alternative medical treatment is available. We do not believe that
Congress intended EPA to make decisions involving medical judgement and
expertise. On such questions, we have and will continue to defer to
FDA.
The commenter states that FDA must approve and determine that the
CFC-containing MDI is essential after notice and an opportunity for
public comment, and asserts that once a drug containing a safe and
effective alternative propellant has been approved by FDA, FDA has no
authority to continue to designate analogous CFC-containing products as
``essential''. Further, the commenter states that EPA may not wait for
FDA to remove that product from its list of essential uses before
finding that it no longer qualifies as a ``medical device'' under the
Act. Again, EPA believes that this interpretation of the Act is flawed.
This is because section 601(8)(B) refers to approval of an alternative
as occurring after ``notice and opportunity for comment.'' Because FDA
does not approve alternative propellants, and because approval of a
specific MDI drug product through the New Drug Application or
Abbreviated New Drug Application system under the FDCA involves
unilateral action by FDA without notice-and-comment rulemaking or
consultation with EPA, it is reasonable to conclude that section
601(8)(B) refers to FDA's approval of an essential use listing in 21
CFR 2.125 which does involve notice and comment rulemaking. Thus, EPA
believes that by allocating CFCs for products covered by the list of
``essential'' products at 21 CFR 2.125, we have fulfilled the
requirements of section 601(8)(B).
Finally, the commenter states that FDA cannot use the categorical
exemptions at 21 CFR 2.125 created more than twenty years ago to
establish the essentiality of particular CFC MDI under the statute
today, and that by doing so EPA and FDA are not relying on standards
adopted under the Act in 1990. EPA believes that our explanation of
this issue in the interim final rule allocating essential use
allowances for calendar year 2000 still stands (see 65 FR 716, January
6, 2000).
While we are aware that FDA is currently engaged in rulemaking to
revise its essential use regulations, we are relying on FDA's current
essential use list at 21 CFR 2.125 for purposes of today's action. The
statute does not specify a particular time at which FDA must make such
a determination or

[[Page 1465]]

invalidate determinations made prior to the date of the 1990 CAA
Amendments. Additionally, the 1990 CAA Amendments use language
consistent with FDA's regulations at 21 CFR 2.125. We presume that
Congress was aware of FDA's regulations when it passed the 1990
Amendments to the CAA. Therefore, we believe that the current essential
use list remains valid. If FDA revises its regulations, we will take
the revised list into account in future allocation decisions. EPA
further notes that both EPA and FDA are implementing the more stringent
provisions of the Montreal Protocol as specified by section 614(b) of
the Act \4\ by following the essentiality determinations of the Parties
to the Montreal Protocol in allocating new CFCs.
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\4\ Section 614(b) states that ``* * * in the case of conflict
between [the Act] and any provisions of the Montreal Protocol, the
more stringent provision shall govern.''
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How Does the CAA Authorize the Exemption for Methyl Chloroform?

With today's action, EPA is allocating methyl chloroform (MCF) for
use in the Space Shuttle and Titan Rockets under the statutory phase-
out schedule at section 604(a). This section provides that MCF may be
produced at up to 20 percent of the amount produced in 1989 (the
baseline year as specified at section 601(2)(B) of the Act). EPA is
allocating a total of 60.1 metric tons of MCF, an amount well below 20%
of the baseline year production of 315,169 metric tons for MCF (defined
at 40 CFR 82.6).
Section 604(a) of the Act requires the complete phase-out of
production of MCF after 2001. As a result, it is likely that EPA will
be required to rely solely upon the exemption under section 604(d)(1),
that may already be applicable, for the year 2002 and beyond. This
exemption reads as follows:

(1) Essential Uses of Methyl Chloroform.--Notwithstanding the
termination of production required by subsection (b), during the
period beginning on January 1, 2002, and ending on January 1, 2005,
the Administrator, after notice and opportunity for public comment,
may, to the extent such action is consistent with the Montreal
Protocol, authorize the production of limited quantities of methyl
chloroform solely for use in essential applications (such as
nondestructive testing for metal fatigue and corrosion of existing
airplane engines and airplane part susceptible to metal fatigue) for
which no safe and effective substitute is available.

EPA understands that research on alternatives is progressing well,
and that in the year 2002 there may be no need for an essential use
exemption for MCF. Nevertheless, EPA believes that section 604(d)(1)
may allow for the continued limited use of methyl chloroform for Space
Shuttle and Titan Rocket through 2004 under the essential use exemption
as long as no substitute is available.

II. Allocation Process for CFCs for Use in Medical Devices for the
Year 2001

As explained earlier, section 604(d)(2) of the Act provides that
EPA shall authorize production and import of limited quantities of
class I substances for use in medical devices if FDA, in consultation
with EPA, determines such authorization to be ``necessary.'' Thus, EPA
in order to implement the exemption for medical devices must receive a
formal determination on the amount of CFCs necessary for use in MDIs
from FDA. FDA sent EPA a letter dated September 6, 2000 that provided
their determination on the amount of CFCs necessary, and explained the
bases for that determination.
One commenter stated that the CAA does not delegate to FDA the
authority to dictate the nomination quantity and allocation of class I
substances for medical devices. Rather, according to the commenter, the
CAA requires that EPA shall consult with FDA only as to whether the
authorization of class I substances for medical devices is necessary,
which requires a yes/no determination only. Thus, EPA should not
transfer to the FDA the responsibility to determine the quantity of
essential use allowances allocated to companies.
EPA has addressed the comment that is raised here in the preamble
to essential use allocation for calendar year 2000 (65 FR 40524, 40530-
40537). We believe that the same interpretation and explanation
provided in the previous rulemaking is applicable here. Section
604(d)(2) states the following: ``The Administrator, after notice and
opportunity for public comment, shall, to the extent such action is
consistent with the Montreal Protocol authorize the production of
limited quantities of class I substances solely for use in medical
devices if such authorization is determined by the Commissioner [of
FDA], in consultation with the Administrator [of EPA], to be necessary
for use in medical devices.'' (emphasis added) EPA believes that it is
clear that the authorization in question is not for an indefinite
amount but for ``limited quantities.'' It is equally clear that the
subject of the Commissioner's determination of necessity is ``such
authorization.'' Thus, if the latter part of the text quoted above were
written in the active voice, it would say: ``if the Commissioner, in
consultation with the Administrator, determines such authorization to
be necessary for use in medical devices.'' We note that the expression
``such authorization'' refers back to the phrase ``authorize the
production of limited quantities of class I substances solely for use
in medical devices.'' Thus, the Commissioner of FDA must consider not
only whether any production is necessary, but what quantity of
production is necessary for MDIs.
Further, although EPA does have some data on CFC usage (which is
shared with FDA), only FDA personnel are privy to confidential business
information regarding annual sales and distribution of MDIs. This
provides FDA with more complete knowledge of the MDI market than EPA.
Because of FDA's access to additional information, and their medical
expertise which is integral to making decisions that serve to protect
the public health, EPA believes it is consistent with Congressional
intent to consult with FDA in making decisions regarding the amount of
CFCs necessary for the production of MDIs.
The commenter's second point was that EPA should ensure that the
rationale for adjustments made to allocations and the bases for FDA
recommendations are open and available to the public for review and
comment. EPA agrees that the allocation process should be as
transparent as possible while accounting for the confidential nature of
the data employed to make the determination on the amount of CFCs
necessary. To this end, EPA and FDA planned a process described in the
NPRM that we felt would allow this determination on the amount of CFCs
necessary to occur as openly as possible. EPA sent letters pursuant to
section 114 of the Act to each essential use applicant requesting
specific information such as the number of units of each product
produced in previous years, the number of units produced in the first
quarter 2000, the gross target fill weight per unit, the total amount
of CFCs to be contained in the product in 2001, the number of units of
each product anticipated to be produced in 2001, the additional amount
of CFCs necessary for production, and the total amount of CFCs
requested for each product in 2001. FDA, in consultation with EPA,
based the determination of necessary amounts and the allocation on this
information. Thus, each company knows what information it has submitted
as the basis for its own allocation while protecting against disclosure
of confidential business information to competitors. Finally, we placed
all non-confidential materials in

[[Page 1466]]

the docket, including the FDA letter of September 6, 2000 that provided
EPA with their recommendation on the amount of CFCs necessary for MDIs
for the year 2001.

III. Allocation of Essential Use Allowances for Calendar Year 2001

EPA is allocating essential use allowances for calendar year 2001
to entities listed in Table I for exempted production or import of the
specific quantity of class I controlled substances solely for the
specified essential use. The allocation of CFCs for use in MDIs
reflects the determination on the amount of CFCs ``necessary'' as
specified under section 604(d)(2) of the Act taking into account two
companies requests for reapportioning EUAs among them.

Table I.--Essential Use Allocation for Calendar Year 2001
------------------------------------------------------------------------
Quantity
Company Chemical (metric tons)
------------------------------------------------------------------------
(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease (in metric tons)
------------------------------------------------------------------------
Medeva, Armstrong Pharmaceuticals CFC-11 or CFC-12 or 189.00
Inc.. CFC-114.
Boehringer Ingelheim CFC-11 or CFC-12 or 338.36
Pharmaceuticals. CFC-114.
Glaxo Wellcome Inc................ CFC-11 or CFC-12 or 858.10
CFC-114.
Aventis Pharmaceuticals........... CFC-11 or CFC-12 or 190.00
CFC-114.
3M Pharmaceuticals................ CFC-11 or CFC-12 or 304.51
CFC-114.
Sidmak Laboratories/Medisol CFC-11 or CFC-12 or 192.20
Laboratories, Inc.. CFC-114.
Schering Corporation.............. CFC-11 or CFC-12 or 1025.20
CFC-114.
Sciarra Laboratories, Inc......... CFC-11 or CFC-12 or 1.30
CFC-114.
------------------------------------------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
Shuttle Rockets and Titan Rockets
------------------------------------------------------------------------
National Aeronautics and Space Methyl Chloroform... 56.7
Administration (NASA)/Thiokol
Rocket.
United States Air Force/Titan Methyl Chloroform... 3.4
Rocket.
------------------------------------------------------------------------

Was the Allocation Listed in This Proposed Rule Changed in the Final
Rule?

The total amount of CFCs allocated for use in MDIs is the same as
in the proposed rule. However, the amount of EUAs allocated to two MDI
companies was reapportioned between them at their request. One
commenter is the New Drug Application (NDA) holder, and the other is a
contract filler for that NDA holder. The NDA holder stated that they
had reassessed the amount of MDIs the contract filler would produce for
them in 2001. The NDA holder requested that a certain amount of EUAs
allocated to their contract filler and earmarked for the production of
the NDA holder's products be re-apportioned back to the NDA holder. The
contract filler provided comments that supported the transfer of EUAs
from them to the NDA holder (this contract filler is also an essential
use allowance holder with its own allocation for production of its own
MDIs). EPA believes that in this case, it is not necessary for FDA to
approve this adjustment to the essential use allocations because the
total amount of EUAs allocated for use in the NDA holder's MDI products
(i.e. the MDIs to be produced by the NDA holder themselves plus the MDI
to be produced by contract filler) remains unchanged. Further, EPA is
implementing provisions to allow transfer of EUAs between MDI
companies. This provision, finalized in today's action, would allow
this transfer to occur even in the absence of EPA re-apportioning the
EUAs among these two companies.
One company requested additional volumes of CFCs beyond the amount
allocated to them in the NPRM. This company stated that it had
anticipated an earlier timing for launch of certain new products, and
that their current supplier of pharmaceutical-grade CFCs may shut down
production in the next few years. For these reasons, they requested
additional EUAs for calendar year 2001 to continue MDI production
without utilizing their strategic reserves.
EPA and FDA have concluded that the year 2001 essential use
allocations already reflect the contingencies raised by the commenter
and are protective of public health. These allocations are calculated
to insure that the full range of medical needs is met throughout the
entire patient population. It should be noted that this company, as
well as all essential use holders, now have the opportunity to obtain
additional EUAs through trading, and also had the opportunity to
request additional CFCs for the year 2002 in response to the notice
requesting essential applications for the years 2002 and 2003 published
November 1, 2000 (65 FR 65311).

Were There Other Comments Regarding the Allocation of CFCs for Use in
MDIs?

One commenter who is a generic producer of MDIs stated that they
were pleased with their proposed allocation. However, they commented
that had they not been allocated EUAs, or had received an extremely low
allocation, opportunities due to unexpected shifts in the market would
fall to foreign manufacturers of MDIs who, the commenter asserts, can
export CFC MDIs to the U.S. and are not subject to the same allocation
requirements as U.S. MDI producers. EPA notes that companies who
produce MDIs in other countries are also subject to the terms of the
Montreal Protocol and must receive an allocation for CFCs to produce
``essential'' MDIs \5\. The major production of MDIs abroad is in
Europe where each company's CFC requirements are also extensively
reviewed before allocation.
---------------------------------------------------------------------------

\5\ EPA believes that all countries that produce MDIs are
parties to the Montreal Protocol.
---------------------------------------------------------------------------

What Was EPA's Method for Allocating Methyl Chloroform (MCF) for Use in
Solid Rocket Motors?

With this action, EPA is allocating 60.1 metric tons of MCF for use
in solid rocket motors, the same amount allocated in the years 1999 and
2000. EPA proposed to allocate MCF in an amount lower than would be
consistent with Decision X/6 taken at the Tenth meeting of the Parties
to the Protocol because we believed, based on knowledge of past MCF
use, that allocating a larger amount would be unnecessary. EPA did not
receive any comments on this issue, and is allocating 60.1 metric tons
MCF as proposed in the NPRM.

[[Page 1467]]

When Is This Rule Effective?

This final rule is effective on January 8, 2001. Section 553(d) of
the APA generally provides that rules may not take effect earlier than
30 days after they are published in the Federal Register. However, APA
section 553(d) excepts from this provision any action that grants or
recognizes an exemption or relieves a restriction. Since today's action
grants an exemption to the phase-out of production and consumption of
CFCs, EPA is making this action effective immediately to ensure the
availability of CFCs for medical devices during calendar year 2001.

Why is EPA Allocating CFC-11, CFC-12, and CFC-114 in the Aggregate To
Each Company?

As discussed in the proposal, EPA is allocating essential use
allowances for CFC-11, CFC-12, and CFC-114 in the aggregate in
accordance with Decision X/6 of the Parties to the Montreal Protocol
which states that ``the quantities approved under paragraph 2 above and
all future approvals are for total CFC volumes with flexibility between
CFCs within each group.'' Allocating CFCs for MDI in the aggregate
instead of on a compound-by-compound basis provides MDI producers with
flexibility in obtaining CFCs without causing additional damage to the
stratospheric ozone layer since CFC-11, CFC-12 and CFC-114 all have the
same ozone depleting potential of 1.0.

Timing of This and Future Essential Use Allocation Rules

One commenter noted that even though EPA sent letters to MDI
companies in May 2000 requesting data needed to determine 2001 EUAs,
the proposed allocation was not published until October. This commenter
requested that EPA make every effort to issue a proposed rule
allocating EUAs for 2002 in September of 2001, and states that as
pharmaceutical-grade CFC production becomes increasingly tenuous, CFC
suppliers are requiring advanced notice of MDI companies' CFC
production needs. Further, MDI companies are unable to provide
suppliers with this information until final EUA allocations are issued.
Earlier rulemakings would help to ensure that MDI manufacturers are
able to place CFC production orders, arrange for shipping, and make
other administrative arrangements in a timely manner. EPA will make
every effort to issue the notice of proposed rulemaking allocating
essential use allowances for 2002 by September of 2001.
Another commenter requested that EPA issue the final CFC
allocations for 2001 as soon as possible so that necessary CFCs may be
ordered and delivered from the supplier in Europe in time to meet MDI
production needs in 2001. EPA has expedited this final rule and
believes that companies should have sufficient time to place their
orders for CFCs for the coming year.

What Reporting Requirements Must I Adhere To When Using My Essential
Use Allocation?

Any person obtaining class I controlled substances after the phase-
out under the essential use exemptions in today's action is subject to
all the restrictions and requirements in other sections of 40 CFR part
82, subpart A. Holders of essential use allowances or persons obtaining
class I controlled substances under the essential use exemptions must
comply with the recordkeeping and reporting requirements in 40 CFR
82.13. Instructions and forms for reporting are found in the Guidance
Document for the Stratospheric Ozone Protection Program after January
1, 1996. This document can be obtained by contacting the Stratospheric
Ozone Protection Hotline at (800) 296-1996 between 10:00 am and 4:00 pm
Eastern Standard Time.
Under 40 CFR 82.3 and 82.4 (63 FR 41626, August 4, 1998), entities
receiving essential use allowances must be the importer of record for
quantities of CFCs brought into the United States. This requires that
the essential use allowance holder be listed as the importer of record
on Customs Form 7501. As a result, the essential use allowance holder
who imports quantities of class I controlled substances is responsible
for submitting both an Importer Quarterly Report and an Essential Use
Holder Quarterly Report.

IV. Transfer of EUAs for CFCs Among Essential Use Allowance Holders

With this action EPA is adding essential use allowances to the list
of allowances that can be transferred under 40 CFR 82.12. This change
will enable companies to transfer EUAs for CFCs to other essential use
holders for the production of MDIs. EPA believes that allowing EUAs to
be transferred among essential use allowance holders will allow MDI
companies to obtain CFCs beyond their allocation without increasing the
total amount of ODSs allocated. EPA received three comments in support
of the provision to allow transfer of EUAs among essential use holders.
These commenters stated that this provision provides a responsible
mechanism for addressing the inherent problem in attempting to predict
the needs for MDI manufacturers.
One commenter requested a clarification of the proposed regulations
regarding the use of a contract filler. The commenter took issue with
the fact that EPA would have to approve the use of a contract filler.
The commenter believes it should be at the company's discretion as to
whether it produces the product in-house or through the use of a
contract filler. The new regulations provide a mechanism for transfer
of EUAs from an NDA holder to a contract filler (provided they already
have EUAs). However, EPA must continue to exercise strict control over
the amount of CFCs produced and or imported to ensure U.S. compliance
with the Decisions of the Parties to the Protocol. Thus, EPA believes
that it is necessary to approve the transfer of EUAs between an NDA
holder and a contract filler. It should be noted that EPA is not
approving or disapproving the use of a contract filler per se, but
merely ensuring that the ``transferor'' has sufficient allowances to
cover the transaction.

Under the New Regulations Can I Transfer EUAs for CFCs To Anyone I
Want?

No; EUAs for CFCs are only transferable among those companies that
have applied for and received EUAs for the year 2001. In addition,
companies must certify in writing to EPA that the EUAs will only be
used in the production of essential medical devices as defined in the
FDCA at 21 CFR 2.125 and considered essential by the Parties to the
Protocol.

Can EUAs for CFCs Be Transferred From Year to Year?

No; EUAs are not transferable from year to year. Any EUAs for CFCs
not expended in 2001 will expire at the end of 2001.

Is There a Cost for Transferring EUAs?

Yes; the CAA at section 607(a) states that rules governing transfer
of allowances for the production of class I and class II substances ``*
* * shall insure that the transactions under the authority of this
section will result in greater total reductions in the production in
each year of class I and class II substances than would occur in that
year in the absence of such transactions.'' In compliance with this
section, current regulations at 40 CFR 82.12 governing transfers of
production and consumption allowances require one percent of the traded
amount to be deducted from the transferor's

[[Page 1468]]

unexpended allowances. EPA proposed to amend the regulations so that in
the case of EUA transfers, one tenth of one percent of the amount
traded would be deducted from the transferor's account. As stated in
the preamble to the proposed rule, EPA believes that given the
relatively small amount of EUAs available for use in MDIs, and that
providing sufficient EUAs for MDIs is critically important for
protecting public health, deducting one percent of the amount of EUAs
to be traded would be too high a penalty and may create a barrier
against transferring EUAs freely. Reducing the amount deducted from the
transferor's account overcomes this potential barrier. EPA received no
adverse comments on this issue, and is amending the regulation as
described above.

How Can I Transfer EUAs From My Company to Another?

In order to complete a transfer of EUAs for CFCs from one essential
use allowance holder to another, the transferor would have to submit to
the Administrator a letter with the information requested in 40 CFR
82.12(a)(1). Under the regulations at 40 CFR 82.12, the transferor must
submit to the Administrator a transfer claim with the following
information:
1. The identities and addresses of the transferor and transferee.
2. The names and telephone numbers of contact persons for both the
transferor and transferee.
3. The type of allowances being transferred, which in this case
would always be essential use allowances.
4. The group of controlled substances being transferred, which
would always be Group I.
5. The amount of allowances being transferred in kilograms.
6. The calendar year for which the allowances are being transferred
(e.g. calendar year 2001).
7. The amount of unexpended essential use allowances for the
current calendar year.
8. The amount of the 0.1% offset applied to the unweighted amount
traded that will be deducted from the transferor's allowance balance.
A sample form that outlines the necessary information that a
transferor must submit to EPA will be available through the
Stratospheric Ozone Hotline at 1-800-296-1996.
As specified in 40 CFR 82.12, EPA will determine, based on records
maintained by the EPA ODS tracking system, whether the transferor
possesses as of the date of the transfer claim, unexpended allowances
sufficient to cover the transfer claim (i.e., the amount to be
transferred plus one tenth of one percent of that amount). Within three
working days of receiving a complete transfer claim, EPA will notify
the transferor and transferee if the transferor has sufficient
unexpended allowances to confer the transfer claim, and will issue a
notice indicating that EPA does not object to the transfer. EPA will
then reduce the transferor's balance of essential use allowances by the
amount to be transferred plus one tenth of one percent of that amount.
When EPA issues a no objection notice, the transferor and the
transferee may proceed with the transfer.
If EPA's records show that the transferor has insufficient
unexpended allowances to cover the transfer claim, or that the
transferor has failed to respond to one or more Agency requests to
supply information needed to make a determination, EPA will issue a
notice disallowing the transfer. Within 10 working days after receipt
of notifications, either party may file a notice of appeal, with
supporting reasons, to EPA, in which case EPA may either affirm or
vacate the disallowance. If no appeal is taken by the tenth working day
after notification, the disallowance shall be final on that day. (The
transferor and transferee will be held liable in accordance with
section 113 of the Act for any violations that occur as a result of an
improper transfer.) In the event that EPA does not respond to a
transfer claim within three working days of receipt of the completed
claim, the transferor and transferee may proceed with the transfer and
EPA will reduce the transferor's balance accordingly.

V. Administrative Requirements

A. 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 by
State, local, and tribal governments, in the aggregate, or by 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. Section 204 of the UMRA requires the
Agency to develop a process to allow elected state, local, and tribal
government officials to provide input in the development of any
proposal containing a significant Federal intergovernmental mandate.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
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. Because this rule imposes no
enforceable duty on any State, local or tribal government it is not
subject to the requirements of sections 202 and 205 of the UMRA. EPA
has also determined that this rule contains no regulatory requirements
that might significantly or uniquely affect small governments;
therefore, EPA is not required to develop a plan with regard to small
governments under section 203. Finally, because this rule does not
contain a significant intergovernmental mandate, the Agency is not
required to develop a process to obtain input from elected state,
local, and tribal officials under section 204.

B. Executive Order 12866

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether this regulatory action is Significant and
therefore subject to OMB review and the requirements of the Executive
Order. The Order defines Significant regulatory action as one that is
likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy,

[[Page 1469]]

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 entitlement, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order. It has been determined by OMB and EPA that this
action is not a Significant regulatory action under the terms of
Executive Order 12866 and is therefore not subject to OMB review under
the Executive Order.

C. Paperwork Reduction Act

This action does not impose any new information collection burden
as defined by the Paperwork Reduction Act (PRA). The Office of
Management and Budget's draft guidance on PRA states that a rule is
exempt from OMB review if it ``explicitly applies to nine or fewer
persons''. Since the reporting requirements in this rule are not of
general applicability, and apply only to the eight entities receiving
EUAs for CFCs, and only if a company decides to transfer EUAs to
another essential use holder, we believe that this rule is exempt from
the requirement of submitting an Information Collection Request and
undergoing OMB review.
However, OMB has previously approved the information collection
requirements that are contained in the existing regulations at 40 CFR
82.12 that set forth the process for inter-company transfers of
consumption allowances under the provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-
0170 (EPA ICR No.1432.17). Copies of the ICR document(s) may be
obtained from Sandy Farmer, by mail at the Office of Environmental
Information, Collection Strategies Division; U.S. Environmental
Protection Agency (2822); 1200 Pennsylvania Ave., NW, Washington, DC
20460, by email at farmer.sandy@epa.gov, or by calling (202) 260-2740.
A copy may also be downloaded off the internet at http://www.epa.gov/
icr. Include the ICR and/or OMB number in any correspondence.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

D. Executive Order 13084: Consultation and Coordination with Indian
Tribal Governments

Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments to provide meaningful and
timely input in the development of regulatory policies on matters that
significantly or uniquely affect their communities.'' Today's rule does
not significantly or uniquely affect the communities of Indian tribal
governments. Accordingly, the requirements of section 3(b) of Executive
Order 13084 do not apply to this rule.

E. Regulatory Flexibility

After considering the economic impacts of today's proposed rule on
small entities, EPA has determined that it is not necessary to prepare
a regulatory flexibility analysis in connection with this rule. EPA has
also determined that this action will not have a significant economic
impact on a substantial number of small entities. This rule does not
have a significant impact on a substantial number of small entities.
There are only ten entities that are affected by this rulemaking (see
table I above). This rule does not have an adverse economic impact on
any entity because it grants exceptions to a pre-existing ban.

F. Applicability of 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 phase-out schedule and exemptions
established by Congress in title VI of the Clean Air Act.

G. 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

[[Page 1470]]

consider the use of any voluntary consensus standards.

H. Executive Order 13132 (Federalism)

Executive Order 13132, entitled ``Federalism'' (64 FR 432255,
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.'' Under
Executive Order 13132, EPA may not issue a regulation that has
federalism implications, that imposes substantial direct compliance
costs, and that is not required by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
If EPA complies by consulting, Executive Order 13132 requires EPA
to provide the Office of Management and Budget, in a separately
identified section of the preamble to the rule, a federalism summary
impact statement (FSIS). The FSIS must include a description of the
extent of EPA's prior consultation with State and local officials, a
summary of the nature of their concerns and the agency's position
supporting the need to issue the regulation, and a statement of the
extent to which the concerns of State and local officials have been
met. Also, when EPA transmits a draft final rule with federalism
implications to OMB for review pursuant to Executive Order 12866, EPA
must include a certification from the agency's Federalism Official
stating that EPA has met the requirements of Executive Order 13132 in a
meaningful and timely manner. This rule will not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132. This rule will affect only the ability of
private entities and the national government to request production of
controlled ozone-depleting substances. Thus, the requirements of
section 6 of the Executive Order to not apply to this rule.

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 the judicial proceedings brought to enforce
those requirements.

VII. Submittal to Congress and the General Accounting Office

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 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 January 8, 2001.

List of Subjects in 40 CFR Part 82

Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Exports, Imports, Reporting and
recordkeeping requirements.

Dated: December 28, 2000.
Carol M. Browner,
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 82.4 is amended by revising the table in paragraph
(t)(2) to read as follows:

Sec. 82.4 Prohibitions.

* * * * *
(t) * * *
(2) * * *

Table I.--Essential use Allocation for Calendar Year 2001
----------------------------------------------------------------------------------------------------------------
Quantity
Company Chemical (metric tons)
----------------------------------------------------------------------------------------------------------------
(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary
Disease (in metric tons)
----------------------------------------------------------------------------------------------------------------
Medeva Americas, Inc..................................... CFC-11 or CFC-12 or CFC-114.......... 189.00
Boehringer Ingelheim..................................... CFC-11 or CFC-12 or CFC-114.......... 338.36
Glaxo Wellcome........................................... CFC-11 or CFC-12 or CFC-114.......... 858.10
Aventis.................................................. CFC-11 or CFC-12 or CFC-114.......... 190.00
3M Pharmaceuticals....................................... CFC-11 or CFC-12 or CFC-114.......... 304.51
Sidmak Laboratories, Inc................................. CFC-11 or CFC-12 or CFC-114.......... 192.20
Schering Corporation..................................... CFC-11 or CFC-12 or CFC-114.......... 1025.20
Sciarra Laboratories, Inc................................ CFC-11 or CFC-12 or CFC-114.......... 1.3
----------------------------------------------------------------------------------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets
----------------------------------------------------------------------------------------------------------------
National Aeronautics and Space Administration (NASA)/ Methyl Chloroform.................... 56.7
Thiokol Rocket.
United States Air Force/Titan Rocket..................... Methyl Chloroform.................... 3.4
----------------------------------------------------------------------------------------------------------------

[[Page 1471]]

* * * * *

3. Section 82.12 is amended by revising paragraphs (a)(1)
introductory text, (a)(1)(i)(H), (a)(1)(ii) introductory text,
(a)(1)(ii)(A), and (a)(1)(iii) to read as follows:

Sec. 82.12 Transfers.

(a) * * *
(1) Until January 1, 1996, for all class I controlled substances,
except for Group VI, and until January 1, 2001, for Group VI, any
person (``transferor'') may transfer to any other person
(``transferee'') any amount of the transferor's consumption allowances
or production allowances, and effective January 1, 1995, for all class
I controlled substances any person (``transferor'') may transfer to any
other person (``transferee'') any amount of the transferor's Article 5
allowances, and after January 1, 2001 any essential use allowance
holder (``transferor'') may transfer essential use allowances for CFCs
to any other essential use allowance holder for CFCs (``transferee'')
solely for the production of essential products (defined at 21 CFR
2.125) as follows:
(i) * * *
(H) The amount of the one percent offset applied to the unweighted
amount traded that will be deducted from the transferor's production or
consumption allowance balance (except for trades from transformers and
destroyers to producers or importers for the purpose of allowance
reimbursement). In the case of transferring essential use allowances,
the amount of one tenth of one percent of the amount traded will be
deducted from the transferor's allowance balance.
(ii) The Administrator will determine whether the records
maintained by EPA, taking into account any previous transfers and any
production, allowable imports and exports of controlled substances
reported by the transferor, indicate that the transferor possesses, as
of the date the transfer claim is processed, unexpended allowances
sufficient to cover the transfer claim (i.e., the amount to be
transferred plus, in the case of transferors of essential use
allowances, one tenth of one percent of the transferred amount, and in
the case of transferors of production or consumption allowances, one
percent of the transferred amount). Within three working days of
receiving a complete transfer claim, the Administrator will take action
to notify the transferor and transferee as follows:
(A) If EPA's records show that the transferor has sufficient
unexpended allowances to cover the transfer claim, the Administrator
will issue a notice indicating that EPA does not object to the transfer
and will reduce the transferor's balance of unexpended allowances by
the amount to be transferred plus, in the case of transfers of
production or consumption allowances, one percent of that amount, or in
the case of transfers of essential use allowances, one tenth of one
percent of that amount. When EPA issues a no objection notice, the
transferor and the transferee may proceed with the transfer. However,
if EPA ultimately finds that the transferor did not have sufficient
unexpended allowances to cover the claim, the transferor and transferee
will be held liable for any violations of the regulations of this
subpart that occur as a result of, or in conjunction with, the improper
transfer.
* * * * *
(iii) In the event that the Administrator does not respond to a
transfer claim within the three working days specified in paragraph
(a)(1)(ii) of this section, the transferor and transferee may proceed
with the transfer. EPA will reduce the transferor's balance of
unexpended allowances by the amount to be transferred plus, in the case
of transfers of production or consumption allowances, one percent of
that amount, and in the case of essential use allowances, one tenth of
one percent of that amount. However if EPA ultimately finds that the
transferor did not have sufficient unexpended allowances to cover the
claim, the transferor and transferee will be held liable for any
violations of the regulations of this subpart that occur as a result
of, or in conjunction with, the improper transfer.
* * * * *
[FR Doc. 01-463 Filed 1-5-01; 8:45 am]
BILLING CODE 6560-50-U

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Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2001: Allocation for Metered Dose Inhalers and the Space Shuttle and Titan Rockets

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