[Federal Register Volume 65, Number 4 (Thursday, January 6, 2000)]
[Rules and Regulations]
[Pages 716-728]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-273]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6519-3]
RIN 2060-AI73
Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2000: Allocations for Metered-Dose
Inhalers and the Space Shuttle and Titan Rockets
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule.
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SUMMARY: With this action, EPA is allocating essential-use allowances
for calendar year 2000 for ozone depleting substances (ODS) for use in
medical devices and for use in the Space Shuttle Rockets and Titan
Rockets for the year 2000 control period. Production and import of ODS
for laboratory and analytical applications will be addressed in a
separate rulemaking. The United States nominated specific uses of
controlled ozone-depleting substances as essential for calendar year
2000 under the Montreal Protocol on Substances that Deplete the Ozone
Layer (Protocol). The Parties to the Protocol subsequently authorized
specific quantities of ODS for calendar year 2000 for the uses
nominated by the United States. EPA allocates essential use allowances
to an applicant for exempted production or import of a specific
quantity of controlled substances solely for the designated essential
purpose. These essential use allowances permit a person to obtain
controlled ODS as an exemption to the January 1, 1996, regulatory
phaseout of production and import.
DATES: This action is effective January 6, 2000. EPA will consider all
written comments received by February 7, 2000 to determine if any
change to this action is necessary.
ADDRESSES: Those wishing to notify EPA of their intent to submit
adverse comments on this action should contact Erin Birgfeld, U.S.
Environmental Protection Agency, Stratospheric Protection Division,
Office of Air and Radiation (6205J), Ariel Rios Building, 1200
Pennsylvania Avenue, NW., Washington, DC, 20460; birgfeld.erin@epa.gov
>; (202) 564-9079 phone and (202) 565-2096 fax. Materials relevant to
this rulemaking are contained in Docket No. A-92-13. The Docket phone
is (202) 260-7548 and is located in room M-1500, First Floor, Waterside
Mall 401 M Street, SW., Washington, DC 20460. The materials may be
inspected from 8 a.m. until 4 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 (800) 296-1996 or Erin Birgfeld, U.S. Environmental
Protection Agency, Stratospheric Protection Division, Office of Air and
Radiation (6205J), Ariel Rios Building, 1200 Pennsylvania Avenue, NW.,
Washington, DC, 20460; birgfeld.erin@epa.gov >; (202) 564-9079 phone
and (202) 565-2096 fax.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Allocation Process for the Calendar Year 2000
III. Allocation of Essential Use Allowances for Calendar Year 2000
IV. Response to Comments
V. Administrative Requirements
VI. Judiciary Review
VII. Congressional Review
I. Background
Overview of the Notice of Proposed Rulemaking
The Notice of Proposed Rulemaking (NPRM) for allocating essential
use allowances was published on November 2, 1999 (64 FR 59141). In the
NPRM, EPA proposed allocating chlorofluorocarbon (CFCs) for use in
metered dose inhalers (MDIs), and methyl chloroform for use in the
Space Shuttle and Titan Rocket. EPA explained that because of
additional requirements in the Clean Air Act that apply beginning in
calendar year 2000, before allocating CFCs for use in MDIs, EPA must
receive a determination from the Food and Drug Administration (FDA)
indicating the amount of CFCs that are necessary for use in MDIs. The
quantities of CFCs proposed to be allocated were the quantities that
were agreed upon at the Eighth Meeting of the Parties to the Montreal
Protocol. FDA's determination of the amount of CFCs that are necessary
for use in MDIs, which EPA has subsequently received, is substantially
lower than what was proposed in the NPRM. The allocations
[[Page 717]]
in this action reflect these lowered amounts. Because stakeholders have
not had a chance to comment on the lower amounts, today's action is
being issued as an interim final rule effective January 6, 2000. This
will allow essential use applicants access to necessary CFCs for
continued production of MDIs, and at the same time will allow for
further comment on and potential changes to the allocation.
In the NPRM, EPA also explained that due to requirements of the CAA
that apply beginning in calendar year 2000, the essential use exemption
for import and production of small amounts of high purity ozone
depleting substances (ODS) for laboratory and analytical uses may not
be available after January 1, 2000. Today's action does not address
this issue. EPA will issue a separate final rule on the topic of
laboratory essential uses.
Overview of the Essential Use Process
The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol) sets specific deadlines for the phaseout of production and
importation of ozone depleting substances (ODS). At their Fourth
Meeting in 1992, the Parties to the Protocol (the Parties) amended the
Protocol to allow exemptions to the phaseout for uses agreed by the
Parties to be essential. At the same Meeting, the Parties also adopted
Decision IV/25, which established criteria for determining whether a
specific use should be approved as essential, and the process for
making such a determination.
The criteria for an essential use as set forth in Decision IV/25
are 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.''
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.
Persons requesting essential use exemptions submit applications
which respond to the specific questions in the 1997 Handbook on
Essential Use Nominations. This document may be obtained from the
Stratospheric Protection Division, U.S. Environmental Protection Agency
or the Ozone Secretariat of the Montreal Protocol in Nairobi. The
Handbook can also be downloaded from the TEAP website at: http://
www.teap.org/html/teap__reports.html.
What does EPA do with the information in the essential use
applications?
The U.S. EPA carefully reviews all the information in each
essential use application and enters the information into a tracking
system which permits year by year comparison of quantities of ODS
requested, quantities allocated, quantities of ODS received in previous
years, and quantities of ODS used for the specific essential activity.
The review of data enables EPA to assess whether entities are
stockpiling ODS, whether there seem to be inflated requests relative to
actual use, and whether there is possible double-counting between
companies. For example, in 1998 we identified some double-counting in
the requests for CFCs among companies. Our analysis also revealed that
there were disparities between the total quantity of CFCs requested for
MDIs and the actual quantity used to manufacture MDIs in previous
years. To account for this inflation in the request for allocation, EPA
reduced the total U.S. nomination for 1998 by 10 percent before
forwarding the applications for consideration by the TEAP and the
Parties to the Protocol.
Every year since 1994, EPA has reviewed applications for essential
uses according to the above criteria and then forwarded the
applications to the Parties. The Parties then review the
recommendations by the TEAP and make final decisions on essential use
nominations.
What are the essential uses that EPA has nominated in the past?
Decision IV/25 was implemented initially in the context of halons
which were phased out of production at the end of 1993. At that time,
nominations for halons were separated from those for other ozone-
depleting substances. EPA issued a Federal Register notice requesting
nominations for essential uses of halons (February 2, 1993; 58 FR
06786). In response, the Agency received over ten nominations, but was
able to work with applicants to resolve their near-term requirements.
As a result, the U.S. did not nominate any uses for continued halon
production in 1994. About a dozen other nations put forth nominations
which were reviewed by the Panel, which determined that in each case
alternatives existed or that the existing supply of banked halons was
adequate to meet near-term needs. The Panel, therefore, did not
recommend approval for any of the nominations. In November of 1993, at
the Fifth Meeting, the Parties unanimously adopted the Panel's
recommendation not to approve any essential uses for production and
consumption of halons in 1994.
EPA issued a second notice requesting applications for essential
use applications for halons for the 1995 control period on October 18,
1993 (58 FR 53722). In response to this inquiry, EPA received no
applications. The TEAP received only one nomination (from France) for
essential use exemptions for halons for production and consumption of
halons for an essential use in 1995. The TEAP did not recommend
approval of this nomination.
In 1993, EPA issued a Federal Register notice requesting essential
use applications for CFCs, methyl chloroform, carbon tetrachloride, and
hydrobromofluorocarbons required beyond the 1996 phaseout of
consumption and production of these class I substances (May 20, 1993,
58 FR 29410). EPA received 20 applications in response to this notice.
For several of these applications, EPA determined that the criteria
contained in Decision IV/25 had not been satisfied. For example, EPA
rejected two applications seeking CFCs for use in servicing air-
conditioning equipment on the basis that adequate supplies of banked
and recycled CFCs were available. However, in rejecting these
nominations, the United States noted that servicing existing air-
conditioning and refrigeration equipment remains a major challenge to
the successful transition from ODSs and that a future nomination in
this area might be necessary if a
[[Page 718]]
combination of retrofits, replacements, recycling, recovery at
disposal, and banking do not adequately address these needs.
In 1993, the United States forwarded essential use nominations to
the Protocol Secretariat for the following uses of CFCs: metered dose
inhalers and other selected medical applications; rocket motor assembly
for the Space Shuttle; aerosol wasp killers; limited use in a specified
bonding agent and polymer application; and a generic application for
laboratory uses under specified limitations. (Letter from Pomerance to
the United Nations Environment Programme (UNEP), September 27, 1993).
The TEAP reviewed over 200 specific uses which were submitted to
the Montreal Protocol Secretariat by the Parties to the Protocol. In
March 1994, the Panel issued the ``1994 Report of the Technology and
Economic Assessment Panel,'' which included the Panel's recommendations
for essential-use production and consumption exemptions. The Panel
recommended that essential use exemptions be granted for nominations
of: methyl chloroform in solvent bonding for the Space Shuttle; CFCs
used in metered dose inhalers; and specific controlled substances
needed for laboratory and analytical applications. For each of the
other nominations submitted, the TEAP determined that one or more of
the criteria for evaluating an essential use had not been satisfied.
The Parties approved essential use exemptions for the uses recommended
in the 1994 TEAP report. The U.S. has continued to request and receive
exemptions for those same uses in subsequent years.
II. Allocation Process for the Calendar Year 2000
The domestic allocation process for this year differs from past
allocations due to changes in the requirements under the Clean Air Act
(CAA or the Act). The purpose of this section is to explain the legal
background behind these changes, and to outline the procedures that EPA
and the Food and Drug Administration (FDA) used to fulfill our
obligations under the CAA in allocating ozone depleting substances for
calendar year 2000.
Prior to the year 2000, EPA allocated essential use exemptions
under the original phase-out schedule contained in section 604 of the
Act. This schedule does not require the complete phaseout of any ODS
prior to calendar year 2000. Under section 606 of the Act, EPA was
obligated to create an accelerated phaseout through regulation to match
the accelerated phaseout under the Protocol. However, EPA had the
flexibility to create exemptions to the regulatory phaseout, where such
exemptions had been approved under the Montreal Protocol. Thus, for the
past several years, EPA has been able to authorize production and
import of ozone-depleting substances for essential uses allowed under
the Protocol, without regard to whether the Act contains exceptions for
those uses, as long as the total authorized production does not exceed
the amount permitted by the Act. However, January 1, 2000, is the
phaseout date under Section 604 of the Act for all class I substances
with the exception of methyl chloroform and methyl bromide. The
phaseout dates for methyl chloroform and methyl bromide are January 1,
2002 and January 1, 2005, respectively. After the phaseout date for a
particular substance has passed, EPA will no longer be able to
authorize production of that substance on the basis of the slower
phaseout schedule under the Act. Because CFCs are to be phased-out by
calendar year 2000 under the original phase-out schedule, EPA must now
implement essential use exemptions for these chemicals as specified
under the Act in section 604(d).
The phaseout date for methyl chloroform under the Act is January 1,
2002. Until that date, the Act permits production and import of methyl
chloroform equivalent to 20% of baseline. The amount of methyl
chloroform allocated for calendar year 2000 is well below this limit.
Beginning in the year 2002, EPA will implement the exception for
essential uses of methyl chloroform found in 604(d)(1) of the Act.
For calendar year 2000, the entities in Table I submitted
applications requesting class I controlled substances for essential
uses. The applications provided information in accordance with the
criteria set forth in Decision IV/25 of the Protocol and the procedures
outlined in the ``1997 Handbook on Essential Use Nominations.'' The
applications requested exemptions for the production and import of
specific quantities of certain class I controlled substances after the
phaseout. The EPA reviewed the applications and nominated these uses to
the Protocol Secretariat for analysis by the TEAP and its Technical
Option Committees (TOCs). The Parties to the Montreal Protocol approved
the U.S. nominations for essential-use exemptions during the Tenth
Meeting in 1998 (Decision IX/18). Today's action allocates essential-
use allowances to U.S. entities as authorized by the Parties to the
Montreal Protocol and to the extent consistent with the CAA.
The Act provides for the following essential use exemptions to the
ban on production and import. Section 604 (d)(2) states that
notwithstanding the phaseout, EPA shall, to the extent consistent with
the Montreal Protocol, authorize production of limited quantities of
class I substances for use in medical devices, if FDA, in consultation
with EPA, determines that such production is necessary. Section
604(d)(3) states that EPA may, to the extent consistent with the
Montreal Protocol, authorize production of limited quantities of halon-
1211, halon-1301, and halon-2402 solely for the purpose of aviation
safety, if the Federal Aviation Administration, in consultation with
EPA, determines that no safe and effective substitute has been
developed and that such authorization is necessary for aviation safety
purposes. Section 604(d)(1) provides that during the period from
January 1, 2002 to January 1, 2005, EPA may, to the extent consistent
with the Montreal Protocol, authorize the production of limited
quantities of methyl chloroform solely for use in essential
applications for which no safe and effective substitute is available.
Section 604(d)(4) states that EPA cannot use any of these three
exemptions to authorize any person to produce a class I substance in
annual quantities greater than 10 percent of that person's baseline
year as defined in Section 601(2). Section 604(g)(3) of the Act
provides that EPA may, to the extent consistent with the Montreal
Protocol, authorize the production of limited quantities of halon-1211,
halon-1301, and halon-2402 after December 31, 1999, and before December
31, 2004 for use in fire suppression and explosion prevention in
association with domestic production of crude oil and natural gas
energy supplies on the North Slope of Alaska, if it is determined that
no safe and effective substitute has been developed and that such
authorization is necessary for fire suppression or explosion prevention
purposes. EPA cannot use this exemption to authorize any person to
produce any of these halons in an amount greater than 3 percent of that
person's baseline. Finally, section 604(f) states that the President
may, to the extent consistent with the Montreal Protocol, provide an
exemption for production of CFC -114, halon-1211, halon-1301, and
halon-2402 as necessary to protect U.S. national security interests, if
the President finds that adequate substitutes are not
[[Page 719]]
available and that the production and use of the substance are
necessary to protect national security interests.
Today's action allocating CFCs for use in MDIs requires EPA to
implement the exception for medical devices found in section 604(d)(2)
of the Clean Air Act. ``Medical device'' is defined in section 601(8)
of the Clean Air Act as follows:
[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].
The preamble to FDA's September 1, 1999, notice of proposed
rulemaking on essential use determinations (64 FR 47735) discusses
FDA's approach to determining whether ``safe and effective
alternative[s]'' have been developed. It states 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. FDA's 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 to
any other product. That requires a separate and distinct analysis.''
FDA has not yet determined that any non-CFC product is a safe and
effective alternative to any CFC MDI. Accordingly, part (A) of the
definition of medical device has not affected today's allocation.
With respect to part (B) of the definition of medical device
(section 601(8)(B)), and in particular the use of the word
``essential'' in that part of the definition, EPA is relying on current
FDA regulations (21 CFR 2.125) which contain a list of uses of CFCs
that FDA in consultation with EPA has found to be essential. This list
includes, among others, metered-dose steroids, metered-dose adrenergic
bronchodilators, metered-dose cromolyn sodium, metered-dose ipratropium
bromide, and metered-dose nedocromil sodium, all drugs for oral
inhalation in humans. The companies for which EPA is granting essential
use allowances produce CFC MDIs that contain these active moieties.
Thus, the products for which EPA is granting essential use allowances
are ``determined to be essential'' by FDA.
Also with respect to part (B) of the definition of ``medical
device'', EPA and FDA considered how to interpret the language
regarding approval by FDA of the ``device, product, drug, or drug
delivery system.'' The complete phrase reads as follows: ``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 in consultation with the Administrator.''
The decision was made to interpret this phrase as referring to FDA's
approval of an essential use and not the approval of the specific
product in question through approval of the New Drug Application (NDA)
or Abbreviated New Drug Application (ANDA) for that product. This means
that any MDI whose active moiety appears on FDA's essential use list is
eligible to receive essential use allowances. This interpretation was
taken for the following reasons. The term ``approved'' must be
interpreted in light of the surrounding language. Section 601(8)(B)
requires notice and comment rulemaking and refers to action by FDA, in
consultation with EPA. Since approval of an NDA or ANDA under the FDCA
involves unilateral action by FDA without notice-and-comment
rulemaking, it is reasonable to conclude section 601(8)(B) does not
refer to approval of an NDA or ANDA under the FDCA. Therefore, FDA and
EPA are interpreting section 601(8)(B) to refer to FDA's approval of an
essential use. This interpretation is consistent with the surrounding
language, since FDA engages in notice-and comment rulemaking in listing
essential uses and since EPA has a strong interest in decisions about
essential uses. This means that an MDI is ``approved and determined to
be essential'' if the MDI contains an active moiety on FDA's essential
use list. All of the MDIs for which we are allocating CFCs today meet
this qualification.
Implementing the essential use exemption for MDIs under the Act
required EPA to consult with FDA regarding the quantity of CFCs to be
allocated. As stated 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. Administrator
Carol Browner sent a letter to Dr. Jane Henney, Commissioner of FDA,
dated October 28, 1999, requesting that FDA make a determination on the
amount of CFCs that are ``necessary'' for the production of MDIs for
calendar year 2000. A December 23, 1999, letter was sent in response
from Commissioner Henney that contains FDA's determination.
EPA also collected additional information relevant to the
allocation. The 1997 TEAP Handbook on Essential Use Nomination
(Handbook), the guidance document for essential use exemption
applications, does not request information regarding specific products
for which the CFCs will be used. As a result, EPA sought more detailed
information including which drug products would be produced using the
allocated CFCs for calendar year 2000. EPA sent out letters to the
essential use applicants (separate letters were sent to the
International Pharmaceutical Aerosol Consortium (IPAC) member
companies) for medical devices, requesting this additional information
under section 114 of the Act. The responses to the letters included
confidential business information on the types of drug products to be
manufactured, as well as the quantity and the specific CFC chemical to
be used in the manufacture of each product. EPA shared the responses to
these letters with FDA to assist it in determining the amount of CFCs
for use in medical devices that are ``necessary.''
Dr. Henney's letter in response to the Administrator dated December
23, 1999, provided FDA's analysis of the amounts of CFCs that FDA
determined are necessary in calendar year 2000 for the production of
medical devices as defined under the Clean Air Act. FDA determined that
a total of 2737.3 metric tons are necessary for use in MDIs for
calendar year 2000. In contrast, the total amount of CFCs proposed to
be allocated in the NPRM (November 2, 1999 64 FR 59141) was 3735 metric
tons. The rationale underlying FDA's determination is provided in Dr.
Henney's December 23, 1999 letter:
``In listing the amounts we believe to be necessary for use in
medical devices, we referred to historical use and have included an
additional amount to allow for overage, for waste during manufacturing,
for uncertainties in the
[[Page 720]]
supply chain of CFCs since they are no longer produced in the United
States, for changes in future market shares of specific products, as
well as for unforeseen circumstances in the market. We also provided
additional amounts based on our knowledge of certain manufacturing
problems. In addition, we eliminated any double-counting we found and
eliminated allocations for uses not considered essential by the parties
to the Montreal Protocol, even if those uses are currently listed in
our regulation at 21 CFR 2.125(e).'' FDA also noted that they accounted
for CFCs for use in the production of MDIs that would ultimately be
exported to Canada.
FDA's determination that 2737.3 metric tons of CFCs are necessary
for use in MDIs is consistent with EPA's data on historical use and
import for MDIs. In order for companies to place an order for CFCs they
must provide a letter from EPA which indicates the amount of CFC that
they are allowed to purchase from chemical producers. Before issuing
these letters, EPA asks companies if they still need the entire
allocation of CFCs. In many cases, companies voluntarily give up part
of their CFC allocation for various reasons. The net result is that the
amount of CFCs actually purchased each year is substantially less than
the amount of CFCs allocated each year. For example, in 1998, 4,363
tons of CFCs were allocated for use in medical devices. However, only
2,235.6 tons were actually imported or produced for MDIs in that year,
and a total of 2,425.5 tons were actually used in the production of
MDIs. Similarly in 1997, 4,656.0 tons of CFCs were allocated for use in
MDIs while 2,032.3 tons were imported or produced, and 2,255.1 tons
were used in MDI production (data from the EPA CFC accounting
framework). Thus, the amount of CFCs that FDA has determined is
``necessary'' is about 300 metric tons higher than EPA's data on actual
use of CFCs in MDIs for 1998. As stated in the letter from FDA, this
additional amount will act as a safety factor accounting for any
unplanned interruptions in CFC supply that could occur during the
course of the year.
As mentioned above, section 604(d)(2) of the Act states that EPA's
allocation must be consistent with the Montreal Protocol. Article 2A(4)
of the Protocol states that Parties such as the United States may not
produce or import CFCs after January 1, 1996, except that the Parties
may decide collectively to permit a specified amount of production or
import for uses that they agree to be essential. The Parties to the
Protocol approved the U.S. nominations for essential use exemptions for
calendar year 2000 during their Tenth Meeting in 1998 (Decision IX/8).
The quantities we are allocating today do not exceed the amounts
approved by the Parties. Therefore, we believe that this action is
consistent with the Protocol.
Can I Submit Comments on This Interim Final Eule?
In the interest of maintaining as open and transparent a process as
possible, this year's allocation for medical devices and the space
program is being issued as an interim final rule instead of a final
rule. This will allow stakeholders to comment on the appropriateness
and accuracy of the allocation while still allowing pharmaceutical
companies access to CFCs in the near term for continued manufacture of
MDIs. Today's action allocates 2737.3 tons of CFCs for use in medical
devices instead of the 3735 metric tons proposed in the NPRM. EPA
received no comments on the NPRM stating that the proposed allocation
was insufficient for an applicant's needs. While we are accepting
comment on the lowered allocation figures, EPA, under the terms of the
Montreal Protocol cannot allocate CFCs in an amount higher than 3735
metric tons because no more than that amount has been approved for
essential use by the Parties to the Montreal Protocol. Because we are
issuing this action as an interim final rule, the following paragraphs
explain the relevant procedures under the CAA and the Administrative
Procedures Act (APA), as well as EPA's findings.
Section 307(d) of the CAA states that in the case of any rule to
which section 307(d) applies, notice of proposed rulemaking must be
published in the Federal Register (CAA 307(d)(3)). The promulgation or
revision of regulations under title VI of the CAA is generally subject
to section 307(d). However, section 307(d) does not apply to any rule
referred to in subparagraphs (A) or (B) of section 553(b) of the
Administrative Procedures Act (APA), 5 U.S.C. 551 et seq.
Section 553 of the Administrative Procedures Act, 5 U.S.C.
553(b)(B), provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the agency may issue a rule without providing
notice and opportunity for public comment. In its proposed rule, 64 FR
59141 (Nov. 2, 1999), EPA provided notice that the allocation of
essential use allowances for MDIs for calendar year 2000 would be made
in accordance with CAA sections 601(8) and 604(d)(2). EPA also provided
preliminary interpretations of the relevant statutory language and
announced that the final allocation would be based on what FDA
determined was ``necessary'' under section 604(d)(2) of the CAA. The
proposed allocation reflected the quantities of CFCs that had been
approved by the Parties to the Montreal Protocol for this use. Because
the quantities that appear in today's allocation differ significantly
from the quantities that appeared in the proposal, EPA has decided to
provide an opportunity for post-promulgation comment on this
allocation.
EPA has determined that there is good cause for making today's
allocation final without prior notice of FDA's determination or an
opportunity to comment on the allocation, as adjusted to reflect FDA's
determination. The allocation of these essential-use allowances to the
specified MDI manufacturers will allow for the pharmaceutical industry
to continue to produce life-saving MDIs for the treatment of asthma and
chronic obstructive pulmonary disease. Thus, prior notice and an
opportunity to comment with regard to today's allocated quantities are
impracticable and contrary to the public interest. EPA finds that this
constitutes good cause under 5 U.S.C. 553(b)(B). Nonetheless, EPA is
providing 30 days for submission of public comments following today's
action. EPA will consider all written comments submitted in the
allotted time period to determine if any change to this action is
required.
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 phaseout
of production and consumption of CFCs, EPA is making this action
effective immediately to ensure the availability of CFCs for medical
devices during the 2000 control period.
III. Allocation of Essential Use Allowances for Calendar Year 2000
What Is EPA's Proposed Essential Use Allocation for Calendar Year 2000?
In today's action, EPA is allocating essential use allowances for
the year 2000 control period to entities listed in Table I for exempted
production or import of the specific quantity of class
[[Page 721]]
I controlled substances solely for the specified essential use. The
final allocation for CFCs for use in MDIs reflects FDA's determination
of the amounts of CFCs that are necessary as specified under section
604(d)(2) of the Act.
Table I.--Essential Use Allocation for Calendar Year 2000
------------------------------------------------------------------------
Quantity
Company Chemical (metric
tons)
------------------------------------------------------------------------
(i) Metered Dose Inhalers for Treatment of Asthma and Chronic
------------------------------------------------------------------------
International Pharmaceutical CFC-11................ 381.0
Aerosol Consortium (IPAC)--Medeva CFC-12................ 1169.0
Americas, Inc., Boehringer CFC-114............... 89.0
Ingelheim Pharmaceuticals, Glaxo
Wellcome, Rhone-Poulenc Rorer, 3M.
Medisol Laboratories, Inc.......... CFC-11................ 13.0
CFC-12................ 29.0
CFC-114............... 7.0
Schering Corporation............... CFC-11................ 301.0
CFC-12................ 747.0
CFC-114............... 0.0
Sciarra Laboratories, Inc.......... CFC-11................ 0.2
CFC-12................ 0.7
CFC-114............... 0.4
------------------------------------------------------------------------
(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.
------------------------------------------------------------------------
The table above reflects FDA's determination of the quantities CFCs
that are necessary for calendar year 2000 and breaks down the amount of
CFC by molecule. However, in developing today's action, EPA has decided
to allocate essential-use allowances in aggregate amounts in accordance
with Decision X/6 of the Parties to the Montreal Protocol. Paragraph 2
of Decision X/6 states that the ``levels of production and consumption
necessary to satisfy essential uses of CFC-11, CFC-12, CFC-113, and
CFC-114, for metered-dose inhalers for asthma and chronic obstructive
pulmonary diseases * * * are authorized as specified in annex I to the
report of the Tenth Meeting of the Parties.'' Paragraph 5 of Decision
X/6 goes on to say that ``the quantities approved under paragraph 2
above and all future approvals are for total CFC volumes with
flexibility between CFCs within each group.'' EPA has determined that
allocating essential-use allowances for CFCs for the manufacture of
metered-dose inhalers in the aggregate instead of on a compound-by-
compound basis will add flexibility for protecting patient health by
allowing companies to better meet market demand for MDIs. Because CFC-
11, CFC-12 and CFC-114 all have an ozone depleting potential of 1.0,
allocating these substances in the aggregate will not cause any
additional damage to the stratospheric ozone layer.
The International Pharmaceutical Aerosol Consortium (IPAC)
consolidated the essential use exemption requests of its member
companies for administrative convenience. EPA will separately allocate
the essential-use allowances that FDA has determined to be
``necessary'' to each of IPAC's member companies by means of a
confidential letter.
Although the Montreal Protocol does allow for a global essential
use exemption for small quantities of high quality Class I ODS for use
in laboratory applications, the CAA does not contain an explicit
exemption for this use. Therefore, import and production of CFCs and
carbon tetrachloride for use in laboratory and analytical applications
may no longer be available for this use. Today's action allocates CFCs
for use in metered dose inhalers and methyl chloroform for use in the
Space Shuttle and the Titan Rocket. Laboratory essential uses will not
be addressed in today's rulemaking. A separate final rule addressing
laboratory essential uses will be published at a later date.
What Reporting Requirements Relate to the Essential Uses of Ozone
Depleting Substances?
Any person obtaining class I controlled substances after the
phaseout 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 record keeping and reporting
requirements in 40 CFR 82.13.
IV. Response to Comments
EPA received comments from six organizations in response to the
proposed rule. Three of these organizations commented on various
aspects of the allocation of ODSs for medical devices, and three
discussed the possibility of the lack of essential use exemptions for
laboratory essential uses. Because a final rule addressing laboratory
essential uses will be published separately at a later date, the only
comments discussed in this section are those regarding the essential
use allocation for medical devices.
One commenter stated that EPA may only authorize production and/or
importation of CFCs for an MDI if EPA determines that there is no safe
and effective alternative propellant to the CFCs used in the MDI. The
commentor asserts that FDA approval of a product under the FDCA means
that the alternative propellant in that product is safe and effective
for purposes of the CAA. The effect of this interpretation would be
limited, according to the commentor, because ``it is only the CFC-
containing product that contains the same active moiety and same
labeled indications that no longer qualifies as a `medical device.' ''
We do not share the commentor's interpretation of the statutory
language.
[[Page 722]]
The first prong of the definition of ``medical device'' reads as
follows: ``The term ``medical device'' means any device * * *,
diagnostic product, drug * * *, and drug delivery system * * * 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.''
According to the commentor, the phrase ``for which no safe and
effective alternative has been developed'' modifies ``class I or class
II substance,'' and not ``device, product, drug, or drug delivery
system.'' The difficulty with the commenter's interpretation is that
FDA does not approve MDI propellants separately from drug products.
Thus, it is impossible for FDA to approve an alternative to the class I
or class II substance (i.e., the propellant) alone since FDA only
approves MDIs under an ANDA or NDA as a whole unit and not by approving
each of its components. For this reason, even if we were to agree with
the commentor that the statutory language was clear on its face, this
would be a situation where the literal meaning of the statutory text
would produce absurd results. We believe that the overall purpose of
the CAA language regarding medical devices is to ensure that EPA's
mission of environmental protection does not conflict with FDA's
mission of protecting the public health. Consistent with this purpose,
we believe that in drafting this prong of the definition, Congress was
focusing on the availability of alternative medical treatment for
patients who rely on CFC MDIs. We are 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 judgment. On such questions, we defer to FDA. Because FDA has
not identified any ``safe and effective alternative,'' as the phrase is
used in the CAA, for any CFC MDI, the first prong of the definition of
``medical device'' has not affected today's allocation.
One commentor asserted that ``the CAA contemplates a product-by-
product determination of essentiality at the time a particular product
is approved,'' and that this principle applies to generic drugs as well
as brand-name drugs. We do not believe that the statutory language
requires each product's essentiality to be determined in a vacuum, as
if no other products of that type existed. The definition of medical
device states that a device, product, drug, or drug delivery system is
a medical device if the first prong of the definition is satisfied and
``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 in consultation with the
Administrator.'' This language does not prevent FDA from grouping
together particular types of products containing the same active moiety
and determining that all products using a given active moiety are
essential. Our understanding is that FDA has always added uses to its
essential use list through notice and comment rulemaking. Because FDA's
list of essential uses is determined by active moiety and makes no
reference as to whether a drug product is generic or branded, we
believe all MDIs for which we are allocating CFCs are covered by 21 CFR
2.125, regardless of whether they were or will be approved under an NDA
or ANDA.
This commentor also objects to EPA's use of FDA's pre-1990
determinations of essentiality in deciding whether an MDI qualifies as
a ``medical device'' for purposes of the 1990 CAA Amendments. The
commentor states that EPA cannot allocate essential use allowances for
particular MDIs until FDA finalizes the proposed revisions to its
essential use regulations or engages in a separate rulemaking to
determine whether those MDIs are essential.
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. That
list contains all of FDA's determinations regarding ``essentiality'' to
date. The statute does not specify a particular time at which FDA must
make such a determination or invalidate determinations made prior to
the date of the 1990 CAA Amendments. Additionally, the 1990 Amendments
to the Clean Air Act 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.
We received several comments on the meaning of the word
``approved'' in section 601(8)(B). In the preamble to the proposed
rule, we stated that EPA and FDA were discussing how best to interpret
this term, and that there were at least two possible interpretations.
One such interpretation was that FDA had to approve the specific
product under the FDCA. The second interpretation was that FDA had to
have approved either that product or another product that contained the
same active moiety. Several commentors stated that the second
interpretation would be contrary to the plain meaning of the statute.
Section 601(8)(B) refers to approval as occurring ``after notice
and opportunity for comment.'' FDA has informed us that approvals of
drug products under the FDCA are issued without notice and comment. For
this reason, FDA has concluded that in using the word ``approved,''
Congress cannot have been referring to approval of the drug product
under the FDCA. We agree with this conclusion. We also note that the
statutory language refers to actions taken by FDA, in consultation with
EPA. FDA does not consult with EPA prior to approving drug products
under the FDCA. Furthermore, FDA points out that it has provided notice
and opportunity for comment prior to adding categories of drug products
to the essential use list in 40 CFR 2.125. (FDA has also informally
consulted with EPA in the course of such actions.) Therefore, FDA
interprets the phrase ``approved and determined to be essential'' as
referring to FDA's action in approving the use of CFCs in MDIs
containing a particular active moiety as an essential use. As a result,
FDA regards all MDIs containing an active moiety that appears on its
essential use list as ``approved'' for purposes of 601(8)(B). According
to this interpretation, an MDI that has not yet received approval of
its ANDA or NDA under the FDCA is considered to be approved as an
essential use if it contains an active moiety that appears on the
essential use list.
Two commentors stated that section 601(8)(B) requires FDA approval
of the ``medical device'' itself and that an active moiety cannot be a
``medical device''. We would like to clarify that the term ``device''
and the phrase ``medical device'' have two separate and distinct
definitions. ``Medical device'' is defined under 601(8) of the CAA.
``Device'' is defined under the FDCA. Furthermore, we are not stating
that the active moiety in an MDI is a ``medical device'' under the CAA.
Rather, FDA and EPA are interpreting section 601(8)(B) to allow MDIs to
be ``approved and determined to be essential'' by active moiety. That
is, if FDA, in consultation with EPA, has listed MDIs containing a
particular active moiety as essential, then a separate determination is
not necessary for each MDI that
[[Page 723]]
contains that active moiety. FDA has listed MDIs with reference to the
active moiety. Therefore, an MDI that contains an active moiety that
appears on FDA's essential use list has been ``approved and determined
to be essential.''
One commentor stated that according to principles of statutory
construction, the term ``approved'' should be interpreted the same way
in section 601(8)(A) and section 601(8)(B). We believe that the term
``approved'' must be interpreted in light of the surrounding language
in each instance. Section 601(8)(B) requires notice-and-comment
rulemaking and refers to action by FDA, in consultation with EPA. Since
approval under the FDCA involves unilateral action by FDA without
notice-and-comment rulemaking, it is reasonable to conclude that
section 601(8)(B) does not refer to approval of an NDA or ANDA under
the FDCA. Instead, we interpret the phrase ``approved and determined to
be essential'' as referring to any MDI that contains an active moiety
appearing on FDA's essential use list. This interpretation is
consistent with the surrounding language, as FDA adds uses to its list
through notice-and-comment rulemaking, and EPA has a clear interest in
being consulted regarding the listing of essential uses of ODS.
In regard to section 601(8)(A), we interpret this section as
requiring a determination by FDA that there is a ``safe and effective
alternative'' to a CFC MDI. Approval under the FDCA may be a
prerequisite to such a determination. (We note that the statutory
language calls for approval ``where necessary.'') Because section
601(8)(A) does not refer to notice and comment rulemaking or
consultation with EPA, it is reasonable to interpret the reference to
``approval'' as a reference to approval under the FDCA. However,
neither EPA nor FDA views FDA approval of a non-CFC product under the
FDCA as constituting a determination that the product is a ``safe and
effective alternative'' to any CFC MDI. That determination would
require a separate analysis. FDA has described some of the factors that
would enter into such an analysis in the preamble to its September 1,
1999 notice of proposed rulemaking on essential use determinations (64
FR 47735), and we refer the reader to that notice for further details.
This commentor also stated that the term ``approved'' as used in
section 601(8)(B) should be interpreted as it is interpreted under the
FDCA, to refer to the entire drug product rather than simply the active
ingredients. For the reasons stated above, we have concluded that the
word ``approved'' in section 601(8)(B) does not refer to approval under
the FDCA.
One commentor stated that EPA had not meaningfully addressed the
requirements of section 604(d)(2) of the CAA, the exception for medical
devices. This commentor stated that EPA must provide information on
``current market demand for the use of CFCs in particular MDIs, what
quantities of CFCs were requested by particular companies in their
annual applications for each particular active moiety and how the
essential use allowances are ``necessary'' or ``limited'', and how the
applicant met its burden of demonstrating that it qualifies for CFCs
under the essential use criteria set out in the Act.''
Section 604(d)(2) of the CAA states that ``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.'' As described in Section II of this
preamble, EPA and FDA have consulted on whether the limited quantities
contained in the proposed rule were ``necessary'' for use in medical
devices, and FDA has determined that 2737.3 tons of the proposed amount
are ``necessary.'' Accordingly, in this interim final rule, EPA is
allocating 2737.3 tons for use in medical devices.
With regard to the commentor's request for information, the letter
from FDA states the following: ``. . . we [FDA] have examine the table
in your [EPA] proposed rule that lists the essential use amounts
requested by sponsors for production of medical devices (64 FR 59143,
Table 1). We have also examined the information you obtained from
individual sponsors regarding their intended use of CFCs in specific
products. We compared this information to the information filed with us
by sponsors in their annual reports.'' FDA goes on to say ``In listing
the amounts we believe to be necessary for use in medical devices, we
referred to historical use and have included an additional amount to
allow for overage, for waste during manufacturing, for uncertainties in
the supply chain of CFCs since they are no longer produced in the
United States, for changes in future market shares of specific
products, as well as for unforeseen circumstances in the market. We
also provided additional amounts based on our knowledge of certain
manufacturing problems. In addition, we eliminated any double-counting
we found and eliminated allocations for uses not considered essential
by the parties to the Montreal Protocol, even if those uses are
currently listed in our regulation at 21 CFR 2.125(e).'' FDA also noted
that they accounted for CFCs for use in the production of MDIs that
would ultimately be exported to Canada. It should be noted that much of
the data that FDA used in their analysis were confidential business
information and cannot be shared publicly. These confidential data
included each applicant's response to EPA's request for information on
the quantity of each CFC to be used in the manufacture of specific
products in calendar year 2000, EPA's historical data on yearly import
and actual use of CFCs for each company, and information filed with FDA
by drug sponsors in their annual reports.
The commentor further stated that in order to achieve the
congressional objective of reducing and eliminating production and use
of ODS ``as expeditiously as possible,'' ``EPA and FDA must conclude
that new MDIs are not `necessary' where FDA has approved or issued an
`apposable' letter for a CFC-free alternative involving the same active
moiety and overlapping labeling as that in the CFC-containing MDI.''
The commentor also states that if EPA nonetheless finds that CFCs are
necessary for these MDIs, EPA must limit the quantities allocated to
those that are necessary until the CFC-free alternative is approved.
The commentor goes on to describe this stance as a ``policy.''
Under section 604(d)(2) of the CAA, FDA (in consultation with EPA)
determines whether production or import of CFCs for MDIs is necessary.
EPA does not independently make such a determination, as the comment
appears to suggest. We defer to FDA on the wisdom of adopting the
policy urged by the commentor. The commentor has not demonstrated that
this policy is compelled by the statutory language. For purposes of
today's action, we are relying on FDA's determination that the
quantities allocated in the final rule are ``necessary.''
One commenter stated that EPA must ensure that its allocation is
consistent with the decisions and recommendations of the Parties to the
Montreal Protocol. The commenter refers to two existing decisions:
Decision IV/25, which provides criteria for assessing essential uses
for purposes
[[Page 724]]
of the Protocol's control measures, and Decision VIII/10, which
addresses the transition away from CFC-based MDIs.
Decision IV/25 contemplates that Parties nominating essential uses
will apply the stated criteria at the time of nomination, and that the
Protocol's Technology and Economic Assessment Panel will apply these
criteria in developing its recommendations on whether the Parties
should approve the nominated uses and quantities at their yearly
meeting. Thus, these criteria drive the essential use process at the
international level. The uses to which we are allocating CFCs in
today's action were approved at the Tenth Meeting of the Parties, after
nomination by the U.S. and evaluation by the Technology and Economic
Assessment Panel. Therefore, we believe today's allocation is
consistent with the Protocol. In addition, the commenter has not
identified any respect in which these uses fail to meet the criteria in
Decision IV/25.
Decision VIII/10 describes a variety of actions that Parties are to
request MDI companies to undertake. For example, Parties are to
``request companies applying for MDI essential-use exemptions to
demonstrate that they are undertaking individual or collaborative
industry efforts, in consultation with the medical community, to
educate health-care professionals and patients about other treatment
options and the transition to non-CFC alternatives.'' (Decision VIII/
10(2)) The TEAP Handbook on Essential Use Nominations was revised in
1997 to incorporate requests relevant to Decision VIII/10. For example,
question B.2. of the form entitled ``Nomination of the Aerosol Metered
Dose Inhaler (MDI) as an Essential Use,'' in Appendix D of the TEAP
Handbook on Essential Use Nominations, requests applicants to ``List
and describe in detail the education efforts, individual and/or
collaborative, being undertaken to advise patients and health care
professionals about treatment options and the transition to non-CFC
alternatives.'' EPA requests companies applying for MDI essential-use
exemptions to submit the information specified in the TEAP Handbook,
including the information relevant to Decision VIII/10 . Nevertheless,
we do not view Decision VIII/10 as imposing barriers to allocation. The
Decision does not attach any consequences to the company's failure to
comply with any of the requests. The commenter incorrectly describes
Decision VIII/10 as ``requiring'' manufacturers of CFC MDIs to take the
specified actions. By its own terms, the Decision simply states that
Parties ``will request'' companies to take these actions.
One commenter stated that under the CAA EPA cannot allocate CFCs to
Medisol Laboratories for use in their generic albuterol MDI because
this product does not fall within the definition of a ``medical
device'' under the statute. For reasons stated above, EPA considers the
generic albuterol MDI to be a medical device as defined by the statute
and thus eligible to receive essential use allowances. While we are
aware that FDA has approved a CFC-free albuterol product, FDA has not
determined that this product is a ``safe and effective alternative'' to
the Medisol generic albuterol MDI. In addition, albuterol is an
adrenergic bronchodilator. FDA continues to regard the use of CFCs in
``[m]etered-dose adrenergic bronchodilator human drugs for oral
inhalation'' as essential (21 CFR 2.125(e)(3)). Because FDA's list of
essential uses makes no reference as to whether a drug product is
generic or branded, we believe all MDIs for which we are allocating
CFCs are covered under 21 CFR 2.125 regardless of whether they were or
will be approved under an NDA or ANDA. Therefore, we believe that CFC
albuterol MDIs are ``medical devices.'' Finally, we have based our
allocation of 49 tons of CFCs to Medisol on FDA's determination that
this quantity is ``necessary'' under CAA section 604(d)(2).
One commenter stated that Sciarra's application for essential use
allowances for production of albuterol, epinephrine hydrochloride,
ipratropium bromide, triamcinalone acetonide, beclomethasone
dipropionate, and cromolyn sodium MDIs should be denied because these
products do not satisfy many, if not all of the requirements set by the
CAA. According to the commenter, an albuterol MDI should not qualify as
a ``medical device'' under the CAA because there is a ``safe and
effective alternative propellant'' (HFC-134a), that is, a safe and
effective alternative to the CFCs used in albuterol MDIs. Additionally,
the commenter stated that FDA has not determined that the generic
products listed above are essential after notice and opportunity for
public comment. The commenter also noted that FDA has issued apposable
letters for CFC-free versions of all the above moieties except
epinephrine and ipratripium, and concluded that even if these products
qualify as ``medical devices,'' the allocation of CFCs is not
``necessary.'' Additionally, the commenter stated that Sciarra's
application provided inadequate information in its response to the
Protocol criteria. Specifically, Sciarra did not provide information
about the availability of alternatives to CFC MDIs or information on
its plans for implementation of these alternatives. The commenter did
note that Sciarra had stated that it would develop its own non-CFC
products after receiving approval for its CFC-containing products.
As stated before, while FDA has approved a CFC-free albuterol
product, FDA has not determined that this product is a ``safe and
effective alternative'' to any other albuterol product. In addition,
albuterol is an adrenergic bronchodilator. FDA continues to regard the
use of CFCs in ``[m]etered-dose adrenergic bronchodilator human drugs
for oral inhalation'' as essential (21 CFR 2.125(e)(3)). Therefore, we
believe that CFC albuterol MDIs are ``medical devices.'' Our
understanding is that FDA has always added uses to its essential use
list through notice and comment rulemaking. Because FDA's list of
essential uses makes no reference as to whether a drug product is
generic or branded, we believe all MDIs for which we are allocating
CFCs are covered under 21 CFR 2.125 regardless of whether they were or
will be approved under an NDA or ANDA. In Sciarra's response to the CAA
section 114 letter that EPA sent to MDI manufacturers on October 13,
1999, Sciarra provided a refined list of moieties for the MDIs for
which it is requesting CFCs. The use of any of these moieties in an MDI
is essential under 21 CFR 2.125(e). With the regard to the issue of
whether CFCs are ``necessary'' for the Sciarra MDIs, we are relying on
FDA's determination. FDA, in its analysis of the amount of CFCs
necessary for the production of MDIs, determined that much of the
quantity we had proposed to allocate to Sciarra was not ``necessary''
because at present, Sciarra does not have any currently approved CFC
MDIs. The essential use allocation for Sciarra was reduced accordingly
in this interim final rule.
The TEAP Handbook contains several questions relating to the
availability of alternatives. As we noted earlier, many of the
questions in the current TEAP Handbook derive from Decision VIII/10.
This Decision directs the Parties to request certain information from
companies applying for MDI essential-use exemptions. However, it does
not attach specific consequences to a company's failure to provide
information, nor does it state what constitutes an adequate response.
[[Page 725]]
One commenter stated that the application for CFCs from Schering
should be denied only if EPA also denies CFC applications for albuterol
MDIs for all other companies marketing such products. The commenter
identified Schering as the company that markets the non-CFC albuterol
MDI. For the reasons stated above, EPA is allocating CFCs to
manufacturers of CFC albuterol MDIs, including Schering.
One commenter stated that the public version of the application for
the International Pharmaceutical Aerosol Consortium (IPAC) did not
provide information about the specific products that would be
manufactured using the essential use allowances. The commenter noted
that Medeva Americas is one of the companies identified in the IPAC
proposal, and stated that this company markets a generic CFC albuterol
MDI. The commenter further stated that another IPAC company, Glaxo
Wellcome, markets a CFC albuterol MDI. According to the commenter,
neither of these companies should receive CFC allocations for these
products.
IPAC completed the application for essential use allowances in
accordance with the TEAP Handbook. EPA requested information about the
specific products for which the allowances would be used from IPAC's
member companies in a letter issued pursuant to section 114 of the CAA
on October 13, 1999. The responses to these letters are considered
confidential business information and are therefore not available in
the public docket. As stated earlier FDA used this information in its
analysis of what quantities of CFCs are necessary for the production of
medical devices as defined in the Act. Each of the products for which
FDA determined a quantity of CFCs to be necessary is ``essential''
under 21 CFR 2.125(e). Since the commenter specifically mentions
albuterol, we note again that albuterol is an adrenergic
bronchodilator. FDA continues to regard the use of CFCs in ``[m]etered-
dose adrenergic bronchodilator human drugs for oral inhalation'' as
essential (21 CFR 2.125(e)(3)). Our understanding is that FDA has
always added uses to its essential use list through notice and comment
rulemaking. Because FDA's list of essential uses makes no reference as
to whether a drug product is generic or branded, we believe all MDIs
for which we are allocating CFCs are covered under 21 CFR 2.125
regardless of whether they were or will be approved under an NDA or
ANDA. Furthermore, as stated before, while FDA has approved a CFC-free
albuterol product, FDA has not determined that this product is a ``safe
and effective alternative'' to any other albuterol product. Therefore,
we believe that CFC albuterol MDIs are ``medical devices.''
One commenter stated that EPA determines the safety and efficacy of
alternatives to CFCs under the Significant New Alternatives Policy
(SNAP) program (section 612 of the CAA). The commenter further stated
that EPA relies upon FDA's approval of medical products containing
alternative propellants as a determination that the alternative
propellant has no adverse human health effects. The commenter concluded
that ``when FDA approves a product containing an alternative propellant
as safe and effective under the FDCA, EPA concludes that the non-CFC
propellant in that product is safe and effective for the purposes of
the CAA.''
Under section 612 of the CAA, EPA determines whether substitutes
for ozone-depleting substances may present adverse effects to human
health or the environment. In the SNAP rule published in the Federal
Register on March 18, 1994 (59 FR 13044), EPA stated: ``Some medical
devices * * * currently contain class I or class II compounds. The
Agency has determined that such products are exempt from further review
for human health effects under the SNAP program where FDA approval of
such effects is required before a product can be introduced into
commerce. EPA will rely in its SNAP determination on FDA's conclusions
regarding health effects. The Agency believes this exemption is
justified because of the higher burden of proof placed on submitters
under the FDCA. However, the Agency will continue to evaluate all other
environmental effects of the proposed substitute, and will consult with
the FDA to determine the appropriate course of action.'' (59 FR
130660).
The quoted language simply indicates that EPA will conclude that a
substitute does not present adverse health effects if FDA approves,
under the FDCA, a product containing the substitute. It does not say
that EPA will treat the product approval as a determination that the
substitute is a ``safe and effective alternative'' to the ODS for
purposes of section 601(8)(A). FDA approval of a CFC-free MDI under the
FDCA does not constitute approval of the non-CFC propellant as safe and
effective. Such approval relates to the product in its entirety, not to
the propellant. Therefore, it would be inappropriate for the EPA to
conclude from FDA's approval of a non-CFC MDI that the non-CFC
propellant had been approved for use in MDIs generally. In listing
acceptable alternatives under the SNAP program, EPA does not intend to
preempt FDA's role in approving individual products or in deciding
whether a particular product is a safe and effective alternative for
another.
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.
[[Page 726]]
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, 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 add any information collection requirements or
increase burden under the provisions of the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. The Office of Management and Budget (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. 1432.16).
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 final rule on
small entities, 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 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. The only entities that are directly affected by this
allocation are those to which CFCs and other ODSs are being allocated.
There are only ten entities which are affected by this rulemaking (see
table 1 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 phaseout 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 No. 104-113, section 12(d) (15
U.S.C. 272 note) directs EPA to use voluntary consensus standards in
its regulatory activities unless to do so would be
[[Page 727]]
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 rule does not involve
technical standards. Therefore, EPA did not consider the use of any
voluntary consensus standards.
H. 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.'' 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 statute, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred 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 to the Office of Management and Budget (OMB), 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 interim final 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 interim final 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 do 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 this 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 this 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. Congressional Review
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. Section 808 allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and public procedure is impracticable,
unnecessary or contrary to the public interest. This determination must
be supported by a brief statement. 5 U.S.C. 808(2). As stated
previously, EPA has made such a good cause finding, including the
reasons therefor, and established an effective date of January 6, 2000.
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Exports,
Hydrochlorofluorocarbons, Imports, Ozone layer, Reporting and
recordkeeping requirements.
Dated: December 30, 1999.
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(t)(2) is amended by revising the table to read as
follows:
Sec. 82.4 Prohibitions.
* * * * * *
(t) * * *
(2) * * *
[[Page 728]]
Table I.--Essential Use Allocation for Calendar Year 2000
------------------------------------------------------------------------
Quantity
Company Chemical (metric
tons)
------------------------------------------------------------------------
(i) Metered Dose Inhalers for Treatment of Asthma and Chronic
------------------------------------------------------------------------
International Pharmaceutical CFC-11 or............. 1639.0
Aerosol Consortium (IPAC)--Medeva CFC-12 or
Americas, Inc., Boehringer CFC-114
Ingelheim Pharmaceuticals, Glaxo
Wellcome, Rhone-Poulenc Rorer, 3M.
Medisol Laboratories, Inc.......... CFC-11 or............. 49.0
CFC-12 or
CFC-114
Schering Corporation............... CFC-11 or............. 1048.0
CFC-12 or
CFC-114
Sciarra Laboratories, Inc.......... CFC-11 or............. 1.3
CFC-12 or
CFC-114
------------------------------------------------------------------------
(2)(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.
------------------------------------------------------------------------
* * * * *
[FR Doc. 00-273 Filed 1-5-00; 8:45 am]
BILLING CODE 6560-50-P
