[Federal Register Volume 64, Number 211 (Tuesday, November 2, 1999)]
[Proposed Rules]
[Pages 59141-59147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28506]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6467-7]
RIN 2060-AI73
Protection of Stratospheric Ozone: Allocation of 2000 Essential
Use Allowances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: With this action, EPA is proposing the allocation of
essential-use allowances for ozone depleting substances (ODS) for the
2000 control period. The United States nominated specific uses of
controlled ozone-depleting substances (ODS) as essential for 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 2000 for the uses nominated by the
United States. Essential use allowances permit a person to obtain
controlled ozone-depleting substances as an exemption to the January 1,
1996 regulatory phaseout of production and import. EPA allocates
essential use allowances to a person for exempted production or
importation of a specific quantity of a controlled substance solely for
the designated essential purpose.
DATES: Written comments on this proposed rule must be received on or
before December 2, 1999, unless a public hearing is requested. Comments
must then be received on or before 30 days following the public
hearing. Any party requesting a public hearing must notify the
Stratospheric Ozone Protection Hotline listed below by 5 p.m. Eastern
Standard Time on November 12, 1999. If a hearing is held, EPA will
publish a document in the Federal Register announcing the hearing
information.
ADDRESSES: Comments on this rulemaking should be submitted in duplicate
(two copies) to: Air Docket No. A-92-13, U.S. Environmental Protection
Agency, 401 M Street, SW., Room M-1500, Washington, DC 20460. Inquiries
regarding a public hearing should be directed to the Stratospheric
Ozone Protection Hotline at 1-800-269-1996.
Materials relevant to this rulemaking are contained in Docket No.
A-92-13. The Docket is located in room M-1500, First Floor, Waterside
Mall at the address above. 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 1-800-296-1996 or Erin Birgfeld, U.S. Environmental
Protection Agency, Stratospheric Protection Division, Office of
Atmospheric Programs, 6205J, 401 M Street, SW., Washington, DC, 20460,
202-564-9079.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Allocation of 2000 Essential Use Allowances
III. Summary of Supporting Analysis
A. Unfunded Mandates Reform Act
B. Executive Order 12875: Enhancing the Intergovernmental
Partnership
C. Executive Order 12866
D. Paperwork Reduction Act
E. Executive Order 13084: Consultation and Coordination With
Indian Tribal Governments
F. Regulatory Flexibility Act
G. Executive Order 13045: Protection of Children from
Environmental Health Risks and Safety Risks
H. National Technology Transfer and Advancement Act
I. Federalism
I. Background
How Are Essential Use Exemptions for Ozone-Depleting Substances
Approved at the International Level?
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 signatories 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
[[Page 59142]]
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.
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 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
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.
Have There Been Any Recent Changes to the Essential Use Process at the
International Level?
At the Eighth Meeting of the Parties in 1996, a new timetable for
nomination of essential uses was established in Decision VIII/9. This
Decision states that Parties may nominate a controlled substance for an
exemption from the production and consumption phaseout by January 31 of
each year to the Ozone Secretariat. EPA has since issued Federal
Register notices calling for essential use applications for class I
controlled substances prior to the Protocol deadline for submission to
the Ozone Secretariat.
Decision V/18 directed the Technology and Economic Assessment Panel
to develop a ``handbook on essential use nominations'' (Handbook). The
July 1994 Handbook contained forms and instructions for how to apply
for an essential-use exemption. Subsequent decisions by the Parties to
the Protocol created additional criteria for essential use
authorizations now reflected in the August 1997 Handbook on Essential
Use Nominations. The Handbook 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 to ensure that it contains complete
information in accordance with the Decisions of the Protocol Parties as
reflected in the Handbook. EPA enters the information from each
application 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 seems
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 them for
consideration by the TEAP and the Parties to the Protocol.
EPA recognizes that since companies must project their need for
CFCs almost two years in advance, the actual needs of a company may
change in the interim. Therefore, prior to allocation, EPA consults
with companies to ensure they still require the total amount of ODS
requested. For example, in 1999
[[Page 59143]]
several essential use applicants voluntarily indicated that they would
not require the total quantity of ODSs requested in their original
application submitted to EPA.
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 Technology and Economic Assessment Panel and
make final decisions on essential use nominations. Today's action
follows decisions taken by the Parties after considering
recommendations by the TEAP in 1998 and 1999.
II. Allocation of 2000 Essential Use Allowances
What Is EPA's Proposed Essential Use Allocation for the Year 2000?
In today's action, EPA is proposing allocation of essential use
allowances for the 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.
Table I.--Essential Uses Agreed to by the Parties to the Protocol for
2000 and Essential Use Allowances
------------------------------------------------------------------------
Quantity
Company Chemical (metric
tonnes)
------------------------------------------------------------------------
(i) Metered Dose Inhalers for Treatment of Asthma and Chronic
Obstructive Pulmonary Disease
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International Pharmaceutical Aerosol CFC-11 588.0
Consortium (IPAC)--Medeva Americas, CFC-12 1516.0
Inc., Boehringer Ingelheim CFC-114 301.0
Pharmaceuticals, Glaxo Wellcome,
Rhone-Poulenc Rorer, 3M.
Medisol Laboratories, Inc............ CFC-11 70.0
CFC-12 120.0
CFC-114 10.0
Schering Corporation................. CFC-11 330.0
CFC-12 680.0
Sciarra Laboratories, Inc............ CFC-11 25.0
CFC-12 75.0
CFC-114 20.0
------------------------------------------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
Shuttle Rockets and Titan Rockets
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National Aeronautics and Space Methyl Chloroform 56.7
Administration (NASA)/Thiokol Rocket.
United States Air Force/Titan Rocket. Methyl Chloroform 3.4
------------------------------------------------------------------------
(iii) Laboratory and Analytical Applications
------------------------------------------------------------------------
Global Exemption (Restrictions in Class I Controlled (\1\)
Appendix G Apply). Substances excluding
CFCs, carbon
tetrachloride,
halons, and HBFCs
(hydrobromoflouro
carbons)
------------------------------------------------------------------------
\1\ No quantity specified.
The International Pharmaceutical Aerosol Consortium (IPAC)
consolidated the essential use exemption requests of its member
companies for administrative convenience. EPA will separately allocate
essential-use allowances to each of IPAC's member companies.
In developing today's action, EPA considered allocating essential-
use allowances 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.'' Thus, EPA is considering allocating essential-use allowances
for CFCs for the manufacture of metered-dose inhalers in the aggregate
instead of on a compound-by-compound basis and seeks comments on this
option. CFC-11, CFC-12 and CFC-114 all have an ozone depleting
potential of 1.0, so an aggregate allocation of essential-use
allowances for all these CFCs would add some flexibility for protecting
patient health by allowing companies to better meet market demand for
MDIs without causing additional damage to the stratospheric ozone
layer.
How Did EPA Determine the Proposed Essential Use Allocation?
Applications submitted by the entities in Table I requested class I
controlled substances for uses deemed essential for the 2000 control
period. 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 specific class I controlled substances after the
phaseout as set forth in 40 CFR 82.4. The U.S. government reviewed the
applications and nominated these uses to the Protocol Secretariat for
analysis by the Technical and Economic Assessment Panel (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
proposes the allocation of essential-use allowances to U.S. entities as
authorized by the Parties to the Protocol and consistent with the Clean
Air Act.
Does the Clean Air Act Permit Production and Import of Ozone-Depleting
Substances for Essential Uses?
The Clean Air Act provides specific exemptions to the phaseout of
ozone-depleting substances; unlike the Protocol, it does not provide
for an open-ended essential use process. Thus, a use that is permitted
under the Protocol may or may not be permitted under the Act. However,
the Act's phaseout schedule for class I substances (except for methyl
bromide) in Section 604 is less stringent than the Protocol phaseout
schedule. For example, in 1999, three years after the phaseout of CFCs
under the Protocol, the Act allows production of 15 percent of the
baseline. (Note, however, that under EPA's regulations, the CFC
phaseout date is the same as that under the Protocol in accordance with
section 606 and 614(b) of the Act.) 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
[[Page 59144]]
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.
The Act's provision for specific exemptions includes the following.
Section 604 (d)(2) of the Act 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, 1992 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 available and
that the production and use of the substance are necessary to protect
national security interests.
How Does the Allocation for the Year 2000 Differ From 1999 and Previous
Years?
Each year, the Parties to the Protocol have approved an unlimited,
global essential use exemption for the production and consumption of
high purity ozone depleting substances for use in laboratory and
analytical techniques. EPA has implemented this exemption domestically
through regulation. However, beginning January 1, 2000 EPA may no
longer be able to allow laboratory essential use exemptions for most
Class I substances because the Act does not specifically list
laboratory and analytical uses as an exception to the phaseout. Thus,
as of January 1, 2000, EPA may no longer be able to grant laboratory
essential use exemptions for CFCs, halons, carbon tetrachloride, or
HBFCs, because the phaseout date under the Act for these substances is
January 1, 2000. It should be noted, however, that EPA believes that
the ban would apply only to the import and production of these class I
ODSs and would not apply to their actual use in the laboratory.
Therefore, EPA believes that laboratories could continue to use
stockpiles of class I ODSs that were produced or imported prior to
January 1, 2000. Trade among companies of class I ODSs that were
produced or imported for laboratory uses prior to January 1, 2000 would
be permitted. The supply of this subset of class I ODSs (which includes
CFCs and carbon tetrachloride) after this date however, would be
finite, and once domestic stockpiles are depleted, laboratories would
cease to have access to these chemicals. EPA solicits comment on the
above interpretation and other possible interpretations of the
statutory requirements related to EPA's ability to grant essential use
exemptions for laboratory and analytical uses.
For the year 2000, EPA is implementing 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].
EPA and FDA are discussing how best to interpret the above
definition of ``medical device.'' With respect to part (A) of the
definition (section 601(8)(A)), which relates to ``safe and effective
alternative[s]'', 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. FDA's preamble points out, and
EPA agrees, 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.''
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 proposes to rely 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 proposing to
grant essential use allowances produce MDIs that are covered by one of
the categories on FDA's essential use list. Thus, the products for
which EPA is proposing to provide essential use allowances belong to
the product categories ``determined to be essential'' by FDA.
Also with respect to part (B) of the definition of ``medical
device'', EPA and
[[Page 59145]]
FDA are discussing at least two interpretations of the language
regarding approval by FDA of the ``device, product, drug, or drug
delivery system.'' First, one could interpret the word ``approved'' as
referring to FDA's approval of the specific product in question through
approval of the New Drug Application (NDA) or Abbreviated New Drug
Application (ANDA) for that product. Alternatively, one could interpret
it as referring to FDA's approval of the same active moiety under that
or any other NDA or ANDA. (FDA regulation at 21 CFR.108(a) defines
active moiety as ``the molecule or ion excluding those appended
portions of the molecule that cause the drug to be an ester, salt
(including a salt with hydrogen or coordination bonds), or other
noncovalent derivatives (such as a complex, chelate or clathrate) of
the molecule, responsible for the physiological or pharmacological
action of the drug substance.'')
The implications of adopting the first interpretation described
above, would require EPA to have more information regarding product
approvals. The 1997 TEAP Handbook on Essential Use Nomination is the
guidance document used for application for essential use exemptions.
Because this Handbook does not request companies to specifically list
the products for which the CFCs will be used, EPA does not have the
information necessary to determine whether the products are in fact
``approved'' by FDA. Therefore, EPA has sent out formal requests for
this additional information under section 114 of the Act to the
pharmaceutical companies who requested CFCs for the year 2000. If the
first interpretation is adopted, EPA will analyze the data received
from these letters and will not allocate CFCs in the final rule for
those individual products that are not approved by FDA. The allocation
in this proposed rule represents the amount allocated by the Parties to
the Montreal Protocol at the Tenth Meeting of the Parties, and may be
reduced in the final rule.
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. EPA and FDA are now
discussing appropriate approaches to implementing the essential use
exemption for medical devices. EPA's final essential use allocation for
the year 2000 will be based on what FDA determines is ``necessary''
under section 604(d)2 of the Act.
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 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.
What Reporting Requirements Must Be Followed for the Essential Uses of
Ozone Depleting Substances?
Any person obtaining class I controlled substances after the
phaseout under the essential use exemptions proposed in today's action
would be 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.
III. Summary of Supporting Analysis
A. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector.
Under section 202 of the UMRA, EPA generally must prepare a written
statement, including a cost-benefit analysis, for proposed and final
rules with ``Federal mandates'' that may result in expenditures by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more in any one year. Before
promulgating an EPA rule for which a written statement is needed,
section 205 of the UMRA generally requires EPA to identify and consider
a reasonable number of regulatory alternatives and adopt the least
costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Section 204 of the UMRA requires the
Agency to develop a process to allow elected state, local, and tribal
government officials to provide input in the development of any
proposal containing a significant Federal intergovernmental mandate.
Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
Today's rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. Because this proposed 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 proposal 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 12875: Enhancing the Intergovernmental Partnership
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a State, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments, or EPA consults with those governments. If EPA complies by
consulting, Executive Order 12875 requires EPA to provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of
[[Page 59146]]
regulatory proposals containing significant unfunded mandates.''
Today's proposed rule does not create a mandate on State, local or
tribal governments. The proposed rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this proposed rule.
C. 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 entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined that this rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.
D. 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.
E. 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 12875
requires EPA to provide to the Office of Management and Budget a
description of the extent of EPA's prior consultation with
representatives of affected State, local and tribal governments, the
nature of their concerns, any written communications from the
governments, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected and other representatives of
Indian tribal governments ``to provide meaningful and timely input in
the development of regulatory policies or matters that significantly or
uniquely affect their communities.''
Today's proposed rule does not significantly or uniquely affect the
communities of Indian tribal governments. The proposed rule does not
impose any enforceable duties on Indian tribal governments.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this rule.
F. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions. This proposed rule would not have a significant impact
on a substantial number of small entities since the rule allocates
CFC's to specific entities which have previously submitted requests.
This proposed rule would not have a significant impact on a
substantial number of small entities, therefore, I hereby certify that
this action will not have a significant economic impact on a
substantial number of small entities. This rule, therefore, does not
require a regulatory flexibility analysis.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health and safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Order has the
potential to influence the regulation. This proposed rule is not
subject to Executive Order 13045 because it implements the phaseout
schedule established by Congress in Title VI of the Clean Air Act.
H. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
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
[[Page 59147]]
EPA to provide Congress, through OMB, explanations when the Agency
decides not to use available and applicable voluntary consensus
standards.
This proposed rule does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.
I. Federalism
On August 4, 1999, President Clinton issued a new executive order
on federalism, Executive Order 13132, [64 FR 43255 (August 10, 1999),]
which will go into effect on November 2, 1999. In the interim, the
current Executive Order 12612, [52 FR 41685 (October 30, 1987),] on
federalism still applies. Under this order, this proposed rule will not
have a substantial direct effect upon States, upon the relationship
between the national government and the States, or upon the
distribution of power and responsibilities among the various levels of
government. This proposed rule will affect only the production of
controlled ozone-depleting substances by private entities.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Exports,
Hydrochlorofluorocarbons, Imports, Labeling, Ozone layer, Reporting and
recordkeeping requirements.
Dated: October 26, 1999.
Carol M. Browner,
Administrator.
40 CFR Part 82 is proposed 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(t)(2) is amended by revising the table to read as
follows:
Sec. 82.4 Prohibitions.
* * * * *
(t) * * *
(2) * * *
Table I.--Essential Uses Agreed to by the Parties to the Protocol for
2000 and Essential Use Allowances
------------------------------------------------------------------------
Quantity
Company Chemical (metric
tonnes)
------------------------------------------------------------------------
(i) Metered Dose Inhalers for Treatment of Asthma and Chronic
Obstructive Pulmonary Disease
------------------------------------------------------------------------
International Pharmaceutical Aerosol CFC-11 588.0.
Consortium (IPAC)--Medeva Americas, CFC-12 1,516.0.
Inc., Boehringer Ingelheim CFC-114 301.0.
Pharmaceuticals, Glaxo Wellcome,
Rhone-Poulenc Rorer, 3M.
Medisol Laboratories, Inc............ CFC-11 70.0.
CFC-12 120.0.
CFC-114 10.0.
Schering Corporation................. CFC-11 330.0.
CFC-12 680.0.
Sciarra Laboratories, Inc............ CFC-11 25.0.
CFC-12 75.0.
CFC-114 20.0.
------------------------------------------------------------------------
(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 Rocket. Methyl Chloroform 3.4.
------------------------------------------------------------------------
(iii) Laboratory and Analytical Applications
------------------------------------------------------------------------
Global Exemption (Restrictions in Class I Controlled No
Appendix G Apply). Substances excluding quantity
CFCs, carbon specified.
tetrachloride,
halons, and HBFCs
(hydrobromoflouro
carbons)
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-28506 Filed 11-1-99; 8:45 am]
BILLING CODE 6560-50-P
