[Federal Register Volume 65, Number 127 (Friday, June 30, 2000)]
[Rules and Regulations]
[Pages 40524-40535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16628]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6726-5]
RIN 2060-A173
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: Final rule.
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SUMMARY: With this action, EPA is allocating essential-use allowances
for calendar year 2000 for stratospheric 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 class I ODS 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
phase-out of production and import of these substances.
EFFECTIVE DATE: This action is effective June 30, 2000.
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 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; [email protected]; (202) 564-9079 phone and
(202) 565-2096 fax.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Allocation Process for Calendar Year 2000
III. Allocation of Essential Use Allowances for Calendar Year 2000
IV. Response to Comments
V. Administrative Requirements
VI. Judicial Review
VII. Congressional Review
I. Background
Overview of the Essential Use Process
The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol) is the international agreement to reduce and eventually
eliminate production and consumption of all stratospheric ozone
depleting substances. This is accomplished through adherence to phase-
out schedules for the production and consumption of specific ODS
including chlorofluorocarbons (CFCs), halons, carbon tetrachloride,
methyl chloroform, hydrochlorofluorocarbons, and methyl bromide. As of
January 1996, production and import of class I ODSs were phased out in
all developed countries, including the United States. However, the
Protocol and the Clean Air Act (CAA or Act) provide exemptions which
allow for the continued import and/or production of class I ODS for
specific uses. Under the Montreal Protocol, exemptions are granted for
uses that are determined by the Parties to be ``essential.'' Decision
IV/25, taken in 1992, established criteria for determining whether a
specific use should be approved as essential, and set forth the
international process for making determinations of essentiality. The
CAA provides for specific exempted uses for which class I ODSs may
continue to be produced and imported.
Once the U.S. nomination for essential use allowances is approved
by the Parties, the U.S. EPA allocates essential use allowances to each
essential use applicant in accordance with the CAA. For the year 2000
and beyond, the CAA requires EPA to formally consult with the Food and
Drug Administration (FDA) on the amount of CFCs that are necessary for
the production of medical devices. On January 6, 2000, EPA issued an
interim final rule (IFR) allocating essential use allowances for use in
metered dose asthma inhalers (MDIs) and in the Space Shuttle and Titan
Rocket (65 FR 716). Today's action allocates essential use allowances
for use in medical devices and reflects the final determination of the
amount of CFCs that are necessary for use in medical devices for
calendar year 2000. This final rule also allocates
[[Page 40525]]
methyl chloroform for use in the Space Shuttle and Titan Rocket solid
rocket motor assemblies.
What Was the International Procedure for Approving Essential Use
Exemptions for the Year 2000?
The international process for nominating and approving essential
use allocations for CFCs for use in medical devices for the year 2000
occurred in the same way as in prior years. The entities in Table I
submitted applications requesting class I controlled substances for
essential uses in response to a Federal Register notice in the Fall of
1998. 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 set forth 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 analysis by the Technical and Economic Assessment Panel
(TEAP) and its Technical Options 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).
Overview of the Notice of Proposed Rulemaking and Interim Final Rule
The Notice of Proposed Rulemaking (NPRM) for allocating essential
use allowances for the year 2000 was published on November 2, 1999 (64
FR 59141). In the NPRM, EPA proposed allocating CFCs for use in metered
dose inhalers (MDIs) that meet the medical device definition in the
Act, and methyl chloroform for use in the Space Shuttle and Titan
Rocket. In the NPRM, EPA proposed to allocate the entire amount of CFCs
for use in MDIs that was granted to the U.S. by the Parties to the
Montreal Protocol, which was 3735 metric tons. However, EPA explained
that because of additional requirements in the Clean Air Act that apply
beginning in calendar year 2000, EPA needed to formally consult with
FDA regarding the amount of CFCs that are necessary for use in medical
devices for calendar year 2000 prior to issuing a final allocation.
Following EPA's consultation with FDA, it was determined that a total
of 2737 metric tons were necessary for production of MDIs for the year
2000. This allocation was reflected in the IFR published on January 6,
2000 (65 FR 716). By issuing the allocation as an interim final instead
of a final rule, EPA ensured that there would be sufficient opportunity
for all stakeholders to comment on the revised allocation while
ensuring that CFCs were available for continued production of MDIs.
Originally EPA planned to receive comments until February 7, 2000,
however, in response to requests by stakeholders, EPA published a
notice in the Federal Register on February 25, 2000 (65 FR 10025)
extending the comment period on the IFR until March 27th, 2000.
EPA received a number of comments on the IFR published January 6,
2000 covering the following areas: the amount of CFCs allocated to
specific companies, the process that EPA used in allocating essential
use allowances for the year 2000, and various legal interpretations of
the medical device exemption provided in the Act. This final rule
revises the allocation of CFCs for use in medical devices to reflect a
final determination of the amount of CFCs necessary for use in medical
devices. EPA consulted with FDA in arriving at this final
determination.
In the NPRM and the interim final rule, EPA 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 laboratory essential uses; these will be
addressed in a separate final rule.
II. Allocation Process for Calendar Year 2000
As discussed in the NPRM and IFR, the domestic allocation process
for calendar year 2000 differs from past allocations due to changes in
the requirements under the CAA. Prior to the year 2000, EPA allocated
essential use exemptions under the original phase-out schedule
contained in section 604 of the Act, and had the flexibility to create
exemptions to the regulatory phase-out, where such exemptions had been
approved under the Montreal Protocol. Thus, before the year 2000, EPA
was able to authorize production and import of ODSs 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
did not exceed the amount permitted by the Act.
Once the phase-out date for a particular substance has passed (as
it has for CFCs), EPA must implement exemptions for essential uses of
these chemicals as specified under the Act in section 604(d).
What Is the Relevant Exemption to the Phase-Out Provided for in the
Act?
In allocating CFCs for use in MDIs, EPA must implement the
exception for medical devices found in section 604(d)(2) of the Act.
This exception states that notwithstanding the phase-out, EPA shall, to
the extent consistent with the Montreal Protocol, authorize production
of limited quantities of class I ODSs for use in medical devices, if
FDA, in consultation with EPA, determines that such production is
necessary.
How Does EPA Interpret the Definition of ``Medical Device'' as
Specified in the 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
[[Page 40526]]
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 categories of
CFC-containing medical devices, as that term is used in the CAA, 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 fall within one of these
categories. 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.''
EPA and FDA determined that in light of the surrounding language, this
phrase refers 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. Since approval of an NDA or ANDA under the Food,
Drug, and Cosmetic Act (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) does not refer to
approval of an NDA or ANDA under the FDCA. Therefore, FDA and EPA read
section 601(8)(B) to refer to FDA's approval of an essential use which
does require notice-and comment rulemaking in consultation with EPA.
This means that an MDI is ``approved and determined to be essential''
if the MDI is included within the list of categories of CFC-MDIs on
FDA's essential use list. All of the MDIs for which we are allocating
CFCs today meet this qualification.
How Did EPA Consult With FDA on the Amount of CFCs Necessary for Use in
Medical Devices?
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.
The 1997 TEAP Handbook on Essential Use Nomination (Handbook), the
guidance document for essential use exemption applications at the
international level, does not request information regarding specific
products for which the CFCs will be used. Therefore, EPA sought more
detailed information including which drug products would be produced
using CFCs allocated in calendar year 2000. EPA sent out letters to the
essential use applicants for medical devices, requesting this
additional information under section 114 of the Act (separate letters
were sent to the International Pharmaceutical Aerosol Consortium (IPAC)
member companies). 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 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
20, 1999, stated that 2737 metric tons of CFCs were necessary for use
in medical devices for the year 2000, in contrast to the 3735 metric
tons proposed to be allocated in the November 2, 1999 NPRM (64 FR
59141). A total of 2737 metric tons was subsequently allocated in the
January 6, 2000 IFR (65 FR 716).
The rationale underlying the FDA determination was provided in Dr.
Henney's letter to EPA dated December 20, 1999. ``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.
Three companies commented that they did not receive sufficient CFC
allocations in the IFR for the production of MDIs to meet their needs
for the year 2000. In lieu of specific written comments, one company
requested a meeting with EPA and FDA. A summary of the meeting is
posted in docket # A-93-39. Based on the information provided by this
company at the meeting, FDA issued a letter to EPA, dated March 6,
2000, in which it stated the factors that had led it to increase the
amount determined to be ``necessary'' (See docket # A-93-39). Relevant
factors included new information about this company's manufacturing
process, and the company's ``contractual obligations to produce product
necessary for patient health on behalf of another company.''
In response to the other two companies who commented that
additional CFCs were necessary, EPA and FDA requested that they provide
the following information: the number of units produced in 1999, the
number of units produced in the first quarter of 2000, the total number
of units anticipated to be produced in 2000, the target fill weight per
unit, total CFC to be contained in the product for 2000, the additional
amount necessary for production of each product, and the total amount
of CFCs per product line for the year 2000.
One company sent EPA the additional information, which was then
shared with FDA. FDA noted some discrepancies between the numbers that
were reported to EPA and those that were reported in that company's
annual report to FDA. The company sent EPA and FDA additional
clarification after which FDA re-assessed their determination on the
amount of CFCs necessary for the year 2000. In their letter dated May
5, 2000 (see docket # A-93-39), FDA states that the company does in
fact require an additional amount for the production of MDIs due
[[Page 40527]]
to greater than anticipated market growth for their products.
For the third company that commented that it did not receive
sufficient CFCs in the IFR, representatives from EPA and FDA
participated in a conference call with representatives from the company
on May 22, 2000 where the company shared the information EPA had
requested pertaining to their past MDI production and future needs with
EPA and FDA verbally. FDA and EPA reviewed the information, taking into
account the following factors enumerated in the December 20, 1999
letter to EPA. These factors include: historical use, the additional
amount necessary for waste and overage during manufacturing,
uncertainties in the supply chain of CFCs, changes in future market
shares of specific products, and unforeseen circumstances in the
market. Based on this review, EPA and FDA agreed that the allocation
published in the IFR is sufficient to meet the needs projected for this
company for the year 2000. In their letter dated June 13, 2000, FDA
determined that an additional amount is not necessary for the
production of their product.
In accordance with the determinations made by FDA in consultation
with EPA, today's allocation on the amount of CFCs necessary for use in
medical devices states that a total of 3136.3 metric tons are necessary
for use in MDIs for calendar year 2000.
When Is This Rule Effective?
This final rule is effective on June 30, 2000. 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 the 2000 control
period.
III. Allocation of Essential Use Allowances for Calendar Year 2000
What Is EPA's Final 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 I controlled
substances solely for the specified essential use. The final allocation
for CFCs for use in MDIs reflects the final determination of the
amounts of CFCs that are necessary as specified under section 604(d)(2)
of the Act. (Note: There is no change from the IFR to the year 2000
allocation for the Space Shuttle and Titan Rockets)
Table I.--Essential Use Allocation for Calendar Year 2000
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Quantity
Company Chemical (metric tons)
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(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary
Disease (in metric tons)
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International Pharmaceutical Aerosol Consortium (IPAC)--Medeva CFC-11 or CFC-12 or CFC- 2038.0
Americas, Inc., Boehringer Ingelheim Pharmaceuticals, Glaxo 114.
Wellcome, Aventis (formerly Rhone-Poulenc Rorer), 3M.
Medisol Laboratories, Inc......................................... CFC-11 or CFC-12 or CFC- 49.0
114.
Schering Corporation.............................................. CFC-11 or CFC-12 or CFC- 1048.0
114.
Sciarra Laboratories, Inc......................................... CFC-11 or CFC-12 or CFC- 1.3
114.
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(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets
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National Aeronautics and Space Administration (NASA)/Thiokol Methyl Chloroform......... 56.7
Rocket.
United States Air Force/Titan Rocket.............................. Methyl Chloroform......... 3.4
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EPA is adding a parenthetical to Table I clarifying that CFCs are
granted for use in the production of MDIs for oral inhalation only. The
Parties to the Montreal Protocol do not consider MDIs for nasal
inhalation to be essential, and thus, under the CAA EPA cannot approve
CFCs for this use or any other use not considered essential by the
Parties to the Protocol. In turn, this means that companies may not use
their essential use allocation to produce a product not considered
essential by the Parties to the Protocol.
Why Is EPA No Longer Allocating CFCs on a Chemical by Chemical Basis?
As discussed in the January 6, 2000 IFR, EPA is allocating
essential-use allowances in aggregate amounts 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.'' EPA has determined that allocating CFCs for the
manufacture of metered-dose inhalers in the aggregate instead of on a
compound-by-compound basis will add flexibility to the regulatory
scheme without causing any 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.
How Will the IPAC Companies Be Informed of Their Individual
Allocations?
The International Pharmaceutical Aerosol Consortium (IPAC)
consolidated the essential use exemption requests of its member
companies for administrative convenience. EPA has already separately
allocated the essential-use allowances allocated in the IFR to each of
IPAC's member companies by means of a confidential letter. EPA will
send a revised allocation letter to those IPAC companies whose
essential use allowances were changed in today's final rule.
What Reporting Requirements Relate to the Essential Uses of Ozone
Depleting Substances?
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
[[Page 40528]]
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.
How Will Essential Use Allowances for Medical Devices Be Allocated in
the Year 2001?
EPA and FDA have worked together to plan a streamlined regulatory
process for the year 2001 and beyond, summarized as follows:
1. In letters sent directly to MDI manufacturers under section 114
of the Act, EPA will request detailed information regarding CFC usage
for the production of MDIs for prior years and projected needs for
2001.
2. EPA will share this information with FDA which will use this
information in consultation with EPA as the basis for the determination
of the amount of CFCs necessary for use in medical devices.
3. EPA will issue a proposed rule setting forth the proposed
allocations of CFCs .
4. EPA plans to issue a final allocation rule by December, 2000 to
provide adequate time for companies to replenish their supply of CFCs
for MDI production in the year 2001. In the proposed allocation rule
for the year 2001, to be published later this year, EPA will explain
the process EPA will use for the essential use allocation in detail and
request formal comment on it.
VI. Response to Comments
Three commenters stated that the amount of CFCs allocated to their
companies in the January 6, 2000 IFR was too low; one company requested
a meeting with the EPA and FDA to discuss their allocation. EPA and FDA
met with this company on Thursday March 2, 2000. A summary of this
meeting is posted in docket # A-93-39. FDA subsequently issued a
supplemental letter to EPA, dated March 6, 2000, in which it stated the
factors that had led it to increase the amount determined to be
necessary. Relevant factors included new information about the
company's manufacturing process and the company's ``contractual
obligations to produce product necessary for patient health on behalf
of another company.''
The second commenter requested additional essential use allowances
with one portion to be used for production in the year 2000, and a
second larger portion to be added to their year 2000 allocation for use
in 2001. EPA and FDA determined that allocating additional amounts of
CFCs to this company in calendar year 2000 for use in 2001 is not
``necessary'' as specified in section 604(d)(2), since EPA will soon be
proposing to allocate CFCs to all essential use applicants with
sufficient advance time for this commenter and other applicants to
acquire additional amounts of CFCs and replenish their supply of CFCs
for 2001. Therefore, in reassessing the amount that was necessary for
the year 2000, EPA and FDA considered only the additional amount that
was requested for use in the year 2000.
As described earlier in the preamble, EPA and FDA requested
additional information from this company to substantiate its claim that
additional CFCs for the year 2000 were necessary. Using this
information, FDA in consultation with EPA, reassessed the amount of CFC
necessary for the year 2000 and found that due to greater than
anticipated market growth, this company does in fact require an
additional amount of CFCs for use in medical devices. This
determination was provided to EPA in a letter from Dr. Jane Henney
dated May 5, 2000.
The third company commented that it should receive the amount of
CFCs that EPA proposed to allocate in the NPRM since giving them a
lesser amount would, in their view, imperil the public health by
possibly reducing access to the lower cost asthma medicines this
company might provide. In their comment, this company did not provide a
statement of need based on the amount of CFC-MDIs they planned to
produce for the year 2000. Therefore, EPA and FDA asked the company to
provide EPA and FDA the same information as the other two companies had
previously provided. Representatives from EPA, FDA, and this company
held a conference call on May 22, 2000 to discuss their request
(minutes are posted in docket # A-93-39). Based on review of the
information that the company provided, FDA, in consultation with EPA,
determined that the additional CFCs requested by this company were not
``necessary'' as defined in 604(d)(2) of the Act.
This same commenter stated that FDA had failed to take into account
several critical issues including: (1) A reduced allowance will
encourage manufacturers holding large allocations to withdraw their
generic products from the marketplace in favor of more expensive, less
effective brand name products; (2) the potential impact of the
withdrawal of certain generic CFC-MDI products may result in a shortage
of this drug, or an increased market share for more expensive brand
name products; (3) if other producers of this product continue to have
manufacturing problems, this could lead to a shortage of the product
overall; (4) shrinking the availability of CFCs may impair FDA's
ability to continue strong Good Manufacturing Practice (GMP)
enforcement; and (5) the reduced allocation will negatively impact
impoverished populations due to a possible shortage of generic CFC-
MDIs.
EPA and FDA have concluded that the year 2000 essential use
allocations already reflect the contingencies raised by the commenter.
As stated previously, FDA, in consultation with EPA, determined
allocations for individual companies based on historical CFC uses while
accounting for uncertainties in manufacturing, including knowledge of
certain manufacturing problems, uncertainties in the CFC supply chain,
and changes in the MDI market. These allocations are calculated to
insure that the full range of medical needs is met throughout the
entire patient population.
Three commenters stated that EPA should not delay its consultation
with FDA and should issue the final rulemaking for the calendar year
2001 allocation earlier in the year. One commenter explained that only
after EPA grants a license for essential use volumes can an MDI
manufacturer place CFC production orders, arrange shipping and make
other administrative arrangements which can take up to 8 weeks before
the CFCs arrive at the manufacturing facility. For this reason, this
particular commenter suggested that EPA begin rulemaking in June, 2000
and issue essential use allowances for 2001 in September, 2000.
EPA has planned the year 2001 allocation process in close
coordination with FDA, and is committed to providing essential use
allowances for the year 2001 in as timely a manner as possible while
fulfilling all of our obligations under the CAA. Although we plan to
begin the rulemaking process in June, the nature of the rulemaking
process and the extensive coordination necessary with FDA are such that
issuing a final rule in September of this year may not be possible. As
stated earlier however, the Agency does plan to issue a final rule
allocating essential use allowances for the year 2001 by December,
2000.
Six commenters expressed surprise at the adjustment of the amount
of CFCs allocated in the IFR for the year 2000, given the figures in
the proposal. EPA proposed to allocate the amount of CFCs approved by
the Parties to the Montreal Protocol for the year 2000. After
[[Page 40529]]
consultation with FDA, EPA ultimately allocated a lower amount. The
process set out by the Protocol Parties requires national governments
to nominate amounts required for essential uses well in advance of
allocation. Making responsible projections of need years in advance of
actual requirement presents difficulties to both companies requesting
CFCs, and to national governments. In past years EPA allocated the
entire amount approved by the Parties and left it up to companies to
elect not to use their entire allocation if it was not necessary. With
this system, often companies do not use their entire allocation. In
fact, in the year 1999, EPA allocated 3665 metric tons of CFCs, while
only 2644 metric tons were actually imported for this use. Similarly,
in 1998, 4,363 tons of CFCs were allocated for use in medical devices
although only 2,235.6 tons were actually imported or produced for MDIs
in that year. Beginning in the year 2000, the CAA requires that EPA and
FDA consider what amount is necessary before the allocation occurs.
This year, because the Agencies were adjusting to the new process, they
did not have time to finish their consultation prior to proposal. EPA
and FDA nonetheless are confident that the numbers actually allocated
better reflect medical need in the U.S. for the year 2000 than the
numbers in either the NPRM or the IFR. Recognizing that the process is
new, however, EPA elected to maximize opportunity for stakeholder input
by publishing the revised determination as an IFR. This procedure
proved valuable, since in the case of some commenters, further
information substantiated a further refinement of the year 2000
allocation. As explained elsewhere in the preamble, EPA plans to issue
the 2001 NPRM after consulting with FDA. This will result in a smoother
process in which all stakeholders will be able to comment on the
allocation, as well as the allocation process itself, after the NPRM is
issued, obviating the need for an IFR.
Five commenters were concerned about the perceived lack of
transparency in the EPA/FDA consultation over the amount of CFCs
determined to be necessary for each company. These commenters felt that
the FDA methodology, assumptions and other bases for determining the
amounts necessary should have been subject to public review and
comment, and that this lack of transparency in the allocation process
should be remedied in the year 2001 and beyond. One commenter stated
that EPA had provided inadequate notice in violation of the
Administrative Procedures Act (APA), and that FDA's determination did
not contain sufficient information to provide the commenter with an
opportunity to provide meaningful comments on a number of significant
issues. (We note that because this rulemaking was conducted under
section 307(d) of the CAA, the relevant procedures are those contained
in that section rather than in the APA.) One commenter stated that
neither agency placed any non-confidential information on the record to
support its determination, and that EPA relied excessively on the FDA
determination on the amount of CFCs necessary. This commenter referred
to section 307(d)(6)(C) of the CAA, which states that ``[t]he
promulgated rule may not be based (in part or in whole) on any
information or data which has not been placed in the docket as of the
date of such promulgation.'' In the opinion of the commenter, contrary
to Section 307(d)(6)(C), the IFR did not appear to have been based on
``information or data'' placed in the docket as of January 6, 2000. The
commenter stated that the docket contains little if any information
supporting EPA's authorization of CFC volumes, and no information
supporting FDA's determination of the volume deemed ``necessary for use
in medical devices''. As a result, the commenter concluded that
interested parties could not comment in an informed manner on the final
allocation.
EPA undertook a variety of measures to ensure that interested
parties had an opportunity for meaningful comment on the allocation.
The Agency published the initial allocation as an interim final rule,
in order to encourage commenters to supply important information and,
potentially, to affect the final allocation. In response to a
commenter's request, EPA extended the comment period to ensure that
commenters who wished to supply important information had adequate time
to do so. In addition to reviewing written submissions, both EPA and
FDA heard oral presentations from companies that disagreed with the
interim final allocation. As described below, EPA attempted to place in
the docket as much information as possible regarding the factual data
on which the rule is based, and the methodology used in obtaining the
data and analyzing the data. However, since much of the data on which
the rule is based is treated as confidential business information, it
has not been possible to include all relevant information in the public
docket.
Dr. Jane Henney, Commissioner of the U.S. Food and Drug
Administration, in her letter dated December 20, 1999, to Carol M.
Browner, Administrator, U.S. EPA, set forth parameters used in
determining the amount of CFCs necessary for MDIs in 2000. FDA provided
further information about its revised determination in Dr. Henney's
letters of March 6, 2000, May 5, 2000, and June 13, 2000 (these
documents are filed in docket no. A-93-39). Composite data on the
amount of CFCs actually used and the amount of CFCs allocated to the
U.S. is compiled each year in a US CFC accounting framework available
in the docket. The docket also contains EPA's letters issued on October
1, 1999, and October 13, 1999 pursuant to section 114 of the CAA
requesting information from MDI manufacturers regarding the specific
products they planned to produce using their essential use allowances
and the amount of CFCs they would use for production in the year 2000.
The responses to these letters contain confidential business
information and thus are not available in the public docket. However,
the types of information requested can be ascertained by examining the
letters that EPA sent out to the MDI manufacturers. EPA provided FDA
with the responses to these letters in the course of our consultation.
EPA agrees that the allocation in the future should be as
transparent a process as possible while accounting for the confidential
nature of the data employed to make the determination on the amount of
CFCs necessary. Briefly, as a first step in assuring this transparency,
EPA plans to describe fully in an upcoming NPRM the proposed process
for future determinations, request comment on it, and carefully review
all comments. EPA and FDA have planned a process which will allow the
determination on the amount of CFCs necessary for each company for the
year 2001 to occur in as open a manner as possible. At the beginning of
the process, EPA will send out letters pursuant to section 114 of the
Act requesting information from each potential essential use holder.
These letters will request information such as the number of units of
each product produced in previous years, the number of units produced
in the first quarter of this year, the gross target fill weight per
unit, the total CFC to be contained in the product for 2000, 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 will compare the
information provided by the companies to information in annual reports
submitted to FDA by the pharmaceutical
[[Page 40530]]
companies requesting an essential use allocation. In general, FDA and
EPA will base the determination of necessary amounts and the allocation
on this information. Thus, each company will know what information it
has submitted as the basis for its own allocation, while the process
will protect against disclosure of confidential business information to
competitors. In addition, stakeholders will have an opportunity to
comment on the proposed allocation prior to EPA issuing the final
allocation for the year 2001.
One commenter proposed a reporting framework for companies to
provide information on their CFC use for 1999 and to project their
needs for the year 2001. EPA appreciates this input, and used the
commenters' suggested reporting framework, along with other
information, as a starting point for our discussions with FDA regarding
the information we will request from companies as a basis for the year
2001 allocation. The reporting framework that was agreed upon for the
year 2001 incorporates most of the information from this suggested
framework, albeit in a slightly different format.
Several commenters took issue with EPA's interpretation of the CAA
exemption for medical devices at section 601(8)(B) of the Act. Some
stated that the term ``approved'' at 601(8)(B) should refer to a
product under an approved NDA or ANDA, and not an approved active
moiety. One commenter reasoned that EPA must interpret ``approved''
consistently in the definition of medical device, as words used in
different parts of the same statute are intended to have the same
meaning. Thus, since the commenter believed that section 601(8)(A)
refers to approved drug products, the commenter argued that section
601(8)(B) must also. Another comment stated that EPA's reading of
``approved and determined to be essential'' as a single action renders
the term ``approval'' meaningless, in violation of principles of
statutory construction. One commenter also stated that EPA's reading of
the word ``approved'' was inconsistent with the FDA September 1, 1999
proposed rule on the transition (64 FR 47735).\1\
---------------------------------------------------------------------------
\1\ The FDA proposed rule on determinations of essentiality
states that ``a food, drug, device, or cosmetic that is, consists in
part of, or is contained in, an aerosol product or other pressurized
dispenser that releases an ODS is an essential use of the ODS under
the Clean Air Act if paragraph (e) of this section specifies the use
of that product as essential. For drugs, including biologics and
animal drugs, and for devices, an investigational application or an
approved marketing application must be in effect, as applicable.''
---------------------------------------------------------------------------
EPA disagrees with these assessments since the word ``approved'' in
section 601(8)(A) refers to an approved alternative and not an approved
drug product. We refer to the explanation in the preamble to the FDA
proposed rule which states ``although FDA approval does constitute a
determination that a product is safe and effective on its own, this
finding does not constitute a determination regarding whether one
product is a medically acceptable alternative for another.'' Further,
FDA's proposed rule does not require the drug product to be approved to
receive CFCs. Rather, both the current regulations under 21 CFR
2.125(e) and the proposed rule by FDA to revise 2.125 contain a
mechanism by which CFC use in an investigational drug may be considered
essential.
Another commenter stated that Section 601(8) of the CAA requires
that each drug product (i.e., ``device, product, drug, or drug delivery
system'') be approved and determined to be essential by FDA before it
can qualify as a medical device under the CAA. The commenter goes on to
state that under accepted rules of statutory construction, a list of
specific items in a statute is intended to be finite, not illustrative,
unless the statute expressly indicates otherwise. Thus, the commenter
argues that because active moieties are not on this list, FDA can only
approve and determine to be essential a device, product, drug, or drug
delivery system. The commenter argues further that its interpretation
is bolstered by the Food, Drug, and Cosmetic Act (FDCA), where
``approved drug'' has been held to mean the entire drug product and not
merely the active ingredients in the drug product. However, the
commenter does not recognize that the term ``drug,'' as used in the
FDCA, can mean either ``drug product'' or ``active moiety.'' EPA, in
consultation with FDA, believes that reading ``drug'' in this provision
of the Act to mean ``active moiety'' most closely effectuates
Congressional intent.
As stated in the preamble to the IFR, it is impossible to read the
term ``approved'' in section 601(8)(B) as referring to approval of an
New Drug Application (NDA) or Abbreviated New Drug Application (ANDA),
considering the context in which that term is used. The passage states
that the public must have notice and an opportunity for comment before
the ``device, product, drug, or drug delivery system'' is ``approved
and determined to be essential.'' FDA has informed us that approvals of
drug products under the FDCA are issued without notice and comment.
Furthermore, as noted in the preamble to the IFR, 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. We refer to the preamble for the IFR for a more detailed
discussion of this issue. As the Supreme Court has noted: ``It is a
fundamental canon of statutory construction that the words of a statute
must be read in their context and with a view to their place in the
overall statutory scheme.'' Davis v. Michigan Dept. of Treasury, 109 S.
Ct. 1504 (1989). Here, the context makes clear that ``approval'' cannot
mean approval of an NDA or ANDA. Thus, the use of the terms
``approved'' and ``determined to be essential'' in the same sentence
may simply be intended to clarify the nature of the action: i.e.,FDA,
in consultation with EPA, makes a determination of essentiality and in
so doing approves an exemption.
Three commenters stated that the CAA does not delegate to the FDA
the authority to dictate the nomination quantity and allocation of
class I substances for medical devices. Rather, the CAA requires only
that the Administrator (of EPA) consult with the Commissioner (of FDA)
as to whether the authorization of class I substances for medical
devices is necessary. The commenters took issue with EPA's reading of
the statute as directing the Commissioner of the FDA to determine the
quantity of class I substances necessary for medical devices. The
commenters believe that the CAA requires the FDA to make a yes/no
decision regarding whether class I substances are necessary for use in
an essential product, i.e., technically necessary for the functioning
of the MDI. According to the commenters, Title VI of the CAA requires
FDA to determine whether a particular approved MDI using an ODS is ``
essential,'' and whether no safe and effective alternatives exist. If
these questions are answered affirmatively, then FDA must consult with
EPA and determine whether CFCs are ``necessary'' for use in MDIs, i.e.,
whether, as a technical matter, the device needs this chemical to
operate properly. If so, then it is EPA's responsibility to determine
``after notice and opportunity for public comment'' what CFC volume
should be authorized for use in those MDIs. Two commenters went on to
state there is no indication that FDA is in a better position to make
decisions on quantity, and that EPA has experience in evaluating the
necessary amount of CFCs from the Agency's past review of companies'
requests for class I substances for use in medical devices.
Section 604(d)(2) of the Act states the following: ``The
Administrator, after notice and opportunity for public
[[Page 40531]]
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). It is clear that the
authorization in question may not be for an indefinite amount but must
be for ``limited quantities.'' It is equally clear that the subject of
the Commissioner's necessity determination 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.
Further, although EPA does have some data on CFC usage (which is
shared with FDA), medical experts at FDA are privy to confidential
business information regarding annual sales and distribution of MDI
products which gives them far more complete knowledge of the MDI market
than EPA. Because of their access to additional information and the
fact that their medical expertise is integral to making these decisions
to protect the health of asthmatics, 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.
Another commenter stated that EPA, in deferring to FDA's decision
regarding the volume of essential use allowances, renders meaningless
the requirement that EPA, not FDA, give interested parties notice and
opportunity to comment on the allocation process. This commenter
believed that MDI manufacturers must have meaningful participation in
the allocation process, and that EPA has delegated this critical
decision to FDA, precluding such participation.
EPA disagrees with this characterization of the process leading to
the allocation. In fact, EPA extensively reviewed the public comments
on the interim final rule with FDA. This allowed a joint reassessment
of the determination of the amount of CFCs necessary. The initial
determination on the amount of CFCs necessary was revised based on
additional information submitted by stakeholders in response to the
interim final rule. In the future, this same type of consultation
between the agencies will occur on any comments that require a
reassessment of the amount of CFCs necessary for use in medical
devices. With this model, it is clear that MDI manufacturers do in fact
have an avenue for actively participating in the allocation of CFCs for
medical devices.
One commenter quoted a passage from the legislative history of the
1990 Amendments (S. Rep No. 228, 101st Cong., 1st Sess. 1989, 1990).
The commenter stated that this passage says nothing about FDA being
required to determine the quantity of ODS that is essential. In
response, we note that the passage simply does not provide any
information regarding interpretation of the phrase: ``if such
authorization is determined by the Commissioner, in consultation with
the Administrator, to be necessary for use in medical devices.'' In
fact, the original Senate language regarding the exception for medical
devices was somewhat different from what appears in the 1990
Amendments. Thus, this passage from the legislative history is of
limited use.
One commenter stated that EPA and FDA's interpretation of the
definition of medical device at section 601(8)(B) could undermine the
clear intent of Congress in enacting Title VI to phase-out CFC-
containing products. According to the commenter, allowing new ODS
products with existing active moieties to be automatically deemed
essential can only perpetuate the use of CFC MDIs. The commenter goes
on to assert that this would likely encourage some U.S. companies to
continue to formulate new CFC MDIs at the same time that other
companies are diligently working to transition away from CFC products.
Finally, this commenter states that the EPA and FDA interpretation is
inconsistent with the overarching objective of the Montreal Protocol,
which is the phase-out of ODS.
FDA's proposed rule on determinations of essentiality will govern
the transition to CFC-free alternatives in a manner that protects both
the environment and the health of patients who require these
medications. EPA is managing this transition in accordance with the
provisions set forth by the CAA and Decisions of the Parties to the
Montreal Protocol, and does not believe that its interpretation of the
CAA as explained in this preamble will in any way delay the transition
to CFC-free alternatives. EPA is allocating essential use allowances
according to FDA's definition of essentiality to ensure that patients
continue to have access to life saving asthma and respiratory disease
medication. The potential entry of a new CFC-MDI product that contains
an active moiety that is already considered essential under both the
Montreal Protocol and FDA's proposed transition rule would not have any
additional environmental impact since the number of asthmatics
requiring medication does not increase to reflect growth in of the
number of different products containing the same active moiety.
One commenter stated that there is no basis in the CAA for changing
the longstanding system for determining the essential use allowance
allocations, and that there is no language in the CAA that suggests an
intention to modify the essential use allocation system in any respect
in the year 2000.
This statement is incorrect. As explained in the NPRM, and the IFR,
prior to the year 2000, EPA allocated essential use exemptions under
the original phase-out schedule contained in section 604(a) of the Act.
This schedule does not require the complete phase-out of any ODS prior
to calendar year 2000. Under section 606 of the Act, EPA was obligated
to create an accelerated phase-out through regulation to match the
accelerated phase-out under the Protocol. However, EPA had the
flexibility to create exemptions to the regulatory phase-out, 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 phase-out date under Section 604 of the Act for all class
I substances with the exception of methyl chloroform and methyl
bromide. Because the phase-out date for CFCs has passed, EPA is no
longer be able to authorize production of that substance on the basis
of the slower phase-out schedule under the Act. Therefore, in this
rulemaking, EPA has implemented for the first time the essential use
exemption for medical devices in section 604(d)(2).
We note that EPA clearly stated in establishing the pre-2000
framework for essential uses that it was not at that time implementing
the exemptions in section 604(d) of the statute, but was instead simply
ensuring that exemptions approved under the Protocol were consistent
with the phase-out schedule
[[Page 40532]]
in section 604(a). Thus, in its 1994 proposed rule, EPA stated:
``Section 604 of the CAA authorizes the granting of specific exemptions
from the phase-out schedules contained in the Clean Air Act * * *
[including] for limited quantities of class I substances solely for use
in medical devices if such authorization is determined to be necessary
* * * In today's action, EPA does not propose essential uses under the
provisions of the CAA. However, EPA does propose to permit continued
production for the essential uses authorized under the Protocol, so
long as these essential use exemptions do not exceed amounts allowed in
the schedule contained in section 604(a) of the CAA.'' 59 FR 56283
(November 10, 1994). Thus, it is clear that in establishing the pre-
2000 essential use framework, EPA was working within the language of
section 604(a), and not section 604(d). As a result, the commenter's
statement that EPA is changing its ``long standing interpretation'' of
section 604(d)(2) is incorrect.
One commenter stated that there is nothing in the legislative
history that suggests any intention to modify the system [of essential
use allowances] that has been followed for over a decade. In this
regard, the statutory text is clear on its face. As explained above, in
this rulemaking EPA is interpreting CAA section 604(d)(2) for the first
time. In the 1990 Amendments, Congress established the year 2000 as the
phase-out date for most class I ODS. This is reflected both in the
table in 604(a) and in 604(b), which states: ``Effective January 1,
2000 * * * it shall be unlawful for any person to produce any amount of
a class I substance.'' Section 604(d)(2) states that ``notwithstanding
the termination of production required by subsection (b),'' EPA shall,
if certain requirements are met, ``authorize the production of limited
quantities of class I substances solely for use in medical devices.''
Thus, Congress clearly gave the year 2000 special significance, and
just as clearly indicated that section 604(d)(2) governs the essential
use process with respect to medical devices after January 1, 2000. As a
result, EPA does not have the option of continuing with the pre-2000
essential use process, but rather must implement section 604(d)(2).
This commenter also stated that FDA and EPA had acted in
contravention of the Waxman-Hatch Act by reducing the amount of
essential use allowances available to a generic MDI manufacturer. The
commenter went on to point out that the prevalence of asthma is
increasing in this country, in particular among low income and minority
populations. They state that EPA and FDA's actions reducing the
allocation of CFCs for a company that produces low-cost generic MDIs
threatens the public health and represents an unreasonable agency
action.
EPA disagrees strongly with this characterization. EPA in
allocating CFCs for use in metered dose inhalers, and FDA in setting up
the framework for the transition to CFC-free asthma medications, are
committed to managing the transition in a manner that in no way
compromises the public health of any population while carrying out a
Congressional directive. Congress clearly did not intend for EPA to
authorize unlimited amounts of CFCs for use in MDIs. Instead, section
604(d)(2) requires that EPA only allocate the amount of CFCs that are
``necessary'' as determined by FDA in consultation with EPA. Both
agencies are committed to providing enough essential use allowances to
protect the public health while fulfilling our obligations under the
CAA and the Montreal Protocol. Additionally, in the case of this
particular company, the allocation they received in the IFR was higher
than the largest amount of CFCs they have used to produce MDIs in any
year since 1996. While, EPA and FDA understand the need for this and
all companies to have some flexibility on the amount of CFCs available
to them, in this particular case, both Agencies believe that a
sufficient amount of flexibility was already built into the allocation
in the IFR. Thus, EPA and FDA believe that the availability of low cost
generic drugs to poor populations will not be affected by allocating
CFCs to this company in the amount published in the IFR.
This commenter also stated that the impact on the ozone layer from
CFC-MDIs is negligible. Under the terms of the Montreal Protocol and as
mandated by the CAA, EPA implements the phase-out of the production and
import of CFCs for all uses. At the same time, Congress and the Parties
to the Protocol understood the need to continue to provide CFCs to
produce CFC-MDIs until safe and effective alternatives are available.
As evidenced by today's rule and the essential use allocation process
since 1996, EPA and FDA are also committed to providing CFCs for
necessary for use in MDIs until a product is no longer considered
essential.
One commenter stated that FDA and EPA now have discretionary
authority under the CAA to require de novo review of the essentiality
of all CFC-containing products. Section 604 of the CAA provides for the
phase out of all class I substances by January 1, 2000. The use of CFCs
in MDIs is exempted from this requirement by section 604(d)(2) which
authorized the use of CFCs in MDIs but only to the extent ``consistent
with the Montreal Protocol.'' Under the Montreal Protocol, Decision IV/
25 states that the use of CFCs in an MDI product is essential only if
the product is ``necessary for the health * * * of society''. This
commenter also states that it is evident that new CFC MDI products
containing the same active moieties already available in existing
products do not automatically meet this criteria.
The commenter may be confusing the domestic and international
processes for determining essentiality. The criteria for determining
essentiality that appear in Decision IV/25 are used only in the
international process. The Parties apply the criteria in Decision IV/25
in deciding whether a specified quantity of CFCs is essential during a
specified year for a specified use. In managing the domestic process,
EPA and FDA look to the requirements of Title VI of the CAA, in
particular the language of sections 601(8) and 604(d)(2). One of the
requirements of section 604(d)(2) is that allocations are to be
``consistent with the Montreal Protocol.'' EPA considers allocations to
be ``consistent with the Montreal Protocol'' if the Parties have
approved the allocated quantities (or greater quantities) for the
specified uses during the specified time period. Hence, EPA will
interpret this comment as a set of recommendations for the application
of the criteria in Decision IV/25 to future nominations.
One commenter stated that while they were pleased to see that EPA
had not allocated as much as proposed, that EPA still was not in
compliance with Section 604 of the CAA. This commenter stated that
pursuant to their comments submitted on the NPRM, EPA should not
authorize essential use allowances for the production of CFC-based
albuterol MDIs since there is a CFC-free alternative on the market. EPA
believes that we addressed this comment fully in the preamble to the
Interim Final Rule (65 FR 716).
One commenter stated that she is an asthma and allergy sufferer and
that she currently uses a variety of medications to treat these
conditions, including MDIs containing CFCs. However, the commenter
stated that she would appreciate help in getting better medications
that contain no CFC's since she is also an environmentalist and also
concerned about the environment.
EPA is committed to balancing the dual goals of protecting patient
health and the environment by nominating essential uses to the Parties
to the
[[Page 40533]]
Montreal Protocol and allocating essential use allowances in a manner
consistent with both the Protocol and the CAA. We understand that it is
critical that these essential use allowances continue to be provided to
companies who produce medical devices essential for the health and
well-being of asthmatics in this country. However, EPA continues to
work hard in areas such as outreach and education to facilitate the
transition to CFC-free products for the treatment of asthma and chronic
obstructive pulmonary disease. EPA refers the commenter to the
following sources of information which provide information on the
current status of the transition to CFC-free alternatives:
1. The EPA stratospheric protection website at http://www.epa.gov/ozone/mdi/mdi.html
2. The FDA website at http://www.fda.gov/cder/mdi/
3. The National Asthma Education and Prevention Program website at
http://www.nhlbi.nih.gov/health/public/lung/asthma/mdiintro.htm.
V. Administrative Requirements
A. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), P.L.
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, 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
[[Page 40534]]
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 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 No. 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
rule does not involve technical standards. Therefore, EOA did not
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 theat 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 (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 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 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 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. 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. As
[[Page 40535]]
stated previously, EPA has made such a good cause finding, including
the reasons therefor, and established an effective date of June 30,
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,
Imports, Ozone layer, Reporting and recordkeeping requirements.
Dated: June 22, 2000.
Carol M. Browner,
Administrator.
40 CFR Part 82 is to be amended as follows:
PART 82--PROTECTION OF STRATOSPHERIC OZONE
1. The authority citation for part 82 continues to read as follows:
Authority: 42 U.S.C. 7414, 7601,7671-7671q.
Subpart A--Production and Consumption Controls
2. Section 82.4 is amended by revising the table in paragraph
(t)(2) to read as follows:
Sec. 82.4 Prohibitions.
* * * * *
(t) * * *
(2) * * *
Table 1--Essential Use Allocation For Calendar Year 2000
----------------------------------------------------------------------------------------------------------------
Quantity
Company Chemical (metric tons)
----------------------------------------------------------------------------------------------------------------
(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary
Disease (in metric tons)
----------------------------------------------------------------------------------------------------------------
International Pharmaceutical Aerosol Consortium (IPAC)--Medeva CFC-11 or................. 2038.0
Americas, Inc., Boehringer Ingelheim Pharmaceuticals, Glaxo CFC-12 or.................
Wellcome, Aventis (formerly Rhone-Poulene Rorer), 3M. CFC-114...................
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...................
----------------------------------------------------------------------------------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets
----------------------------------------------------------------------------------------------------------------
National Aeronautics and Space Administration (NASA)/Thiokol Methyl Chloroform......... 56.7
Rocket.
United States Air Force/Titan Rocket.............................. Methyl Chloroform......... 3.4
----------------------------------------------------------------------------------------------------------------
[FR Doc. 00-16628 Filed 6-29-00; 8:45 am]
BILLING CODE 6560-50-P