[Federal Register Volume 64, Number 16 (Tuesday, January 26, 1999)]
[Rules and Regulations]
[Pages 3865-3869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1765]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6224-7]
RIN 2060-AG12
Protection of Stratospheric Ozone: Listing Hexafluoropropylene
(HFP) and HFP-Containing Blends as Unacceptable Refrigerants Under
EPA's Significant New Alternatives Policy (SNAP) Program
AGENCY: Environmental Protection Agency (EPA).
ACTION: Interim final rule.
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SUMMARY: With this action, EPA's Significant New Alternatives Policy
(SNAP) program lists as unacceptable for all refrigeration and air-
conditioning end-uses hexafluoropropylene (HFP) and any blend
containing HFP. Today's action responds to EPA's recent discovery of
toxicity data concerning HFP, which present significant concerns about
risks to human health that may arise as a result of exposure to HFP,
either as a single chemical or in a blend, in the refrigeration and
air-conditioning sector. Therefore, EPA is listing HFP and all HFP-
containing blends as unacceptable substitutes for CFC-12 and HCFC-22 in
this sector.
DATES: Effective Date: This action is effective January 26, 1999.
Comments: EPA will consider all written comments received by February
25, 1999 to determine if any change to this action is necessary.
ADDRESSES: Information relevant to this notice is contained in Air
Docket A-91-42, Central Docket Section, South Conference Room 4, U.S.
Environmental Protection Agency, 401 M Street, S.W., Washington, D.C.
20460, telephone: (202) 260-7548. The docket may be inspected between
8:00 a.m. and 5:30 p.m. weekdays. As provided in 40 CFR Part 2, a
reasonable fee may be charged for photocopying. Those wishing to notify
EPA of their intent to submit adverse comments on this action should
contact Kelly Davis, U.S. EPA, Stratospheric Protection Division,
Office of Atmospheric Programs, Office of Air and Radiation (6205-J),
401 M Street, S.W., Washington, DC 20460, (Docket # A-91-42), (202)-
564-2303.
FOR FURTHER INFORMATION CONTACT: Kelly Davis, U.S. EPA, Stratospheric
Protection Division, Office of Atmospheric Programs, Office of Air and
Radiation (6205-J), 401 M Street, S.W., Washington, DC, 20460, (202)-
564-2303 or electronically at davis.kelly@epa.gov. General information
about EPA's SNAP program can be found by calling EPA's Stratospheric
Ozone Protection Hotline at (800) 296-1996 or by viewing EPA's SNAP
Program world wide web site at www.epa.gov/ozone/title6/snap/snap.html.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Section 612 Program
A. Statutory Requirements
B. Regulatory History Background
C. Listing of Substitutes
D. Necessity for Interim Final Rule
II. Listing of HFP and HFP-Containing Blends as Unacceptable
III. Summary of Supporting Analyses
A. Unfunded Mandates Reform Act and Regulatory Flexibility Act
B. Executive Order 12866: Review of Significant Regulatory
Actions by OMB
C. Paperwork Reduction Act
D. Executive Order 12875: Enhancing Intergovernmental
Partnerships
E. Submission to Congress and the General Accounting Office
F. Executive Order 13045: Children's Health Protection
G. Executive Order 13084: Consultation and Coordination With
Indian Tribal Governments
IV. Additional Information
I. Section 612 Program
A. Statutory Requirements
Section 612 of the Clean Air Act authorizes EPA to develop a
program for evaluating alternatives to ozone-depleting substances. EPA
refers to this program as the Significant New Alternatives Policy
(SNAP) program. The major provisions of section 612 are:
Rulemaking--Section 612(c) requires EPA to promulgate
rules making it unlawful to replace any class I (chlorofluorocarbon,
halon, carbon tetrachloride, methyl chloroform, methyl bromide, and
hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance
with any substitute that the Administrator determines may present
adverse effects to human health or the environment where the
Administrator has identified an alternative that (1) reduces the
overall risk to human health and the environment, and (2) is currently
or potentially available.
Listing of Unacceptable/Acceptable Substitutes--Section
612(c) also requires EPA to publish a list of the substitutes
unacceptable for specific uses. EPA must publish a corresponding list
of acceptable alternatives for specific uses.
[[Page 3866]]
Petition Process--Section 612(d) grants the right to any
person to petition EPA to add a substance to or delete a substance from
the lists published in accordance with section 612(c). The Agency has
90 days to grant or deny a petition. Where the Agency grants the
petition, EPA must publish the revised lists within an additional six
months.
90-day Notification--Section 612(e) requires EPA to
require any person who produces a chemical substitute for a class I
substance to notify the Agency not less than 90 days before new or
existing chemicals are introduced into interstate commerce for
significant new uses as substitutes for a class I substance. The
producer must also provide the Agency with the producer's unpublished
health and safety studies on such substitutes.
Outreach--Section 612(b)(1) states that the Administrator
shall seek to maximize the use of federal research facilities and
resources to assist users of class I and II substances in identifying
and developing alternatives to the use of such substances in key
commercial applications.
Clearinghouse--Section 612(b)(4) requires the Agency to
set up a public clearinghouse of alternative chemicals, product
substitutes, and alternative manufacturing processes that are available
for products and manufacturing processes which use class I and II
substances.
B. Regulatory History Background
On March 18, 1994, EPA published the Final SNAP Rule (59 FR 13044)
which described the process for administering the SNAP program and
issued EPA's first acceptability lists for substitutes in the major
industrial use sectors. These sectors include: refrigeration and air
conditioning; foam blowing; solvent cleaning; fire suppression and
explosion protection; sterilants; aerosols; adhesives, coatings and
inks; and tobacco expansion. These sectors compose the principal
industrial sectors that historically consumed the largest volumes of
ozone-depleting compounds.
The Agency defines a ``substitute'' as any chemical, product
substitute, or alternative manufacturing process, whether existing or
new, that could replace a class I or class II substance. Anyone who
produces a substitute must provide the Agency with health and safety
studies on the substitute at least 90 days before introducing it into
interstate commerce for significant new use as an alternative. This
requirement applies to chemical manufacturers, but may include
importers, formulators or end-users when they are responsible for
introducing a substitute into commerce.
C. Listing of Substitutes
To develop the lists of unacceptable and acceptable substitutes,
EPA conducts screens of health and environmental risks posed by various
substitutes for ozone-depleting compounds in each use sector. The
outcome of these risk screens can be found in the public docket.
Under section 612, the Agency has considerable discretion in the
risk management decisions it can make under the SNAP program. The
Agency has identified five possible decision categories: acceptable,
acceptable subject to use conditions; acceptable subject to narrowed
use limits; unacceptable; and pending. Acceptable substitutes can be
used for all applications within the relevant sector end-use.
Conversely, it is illegal to replace an ozone-depleting substitute with
a substitute listed by SNAP as unacceptable for that end-use. A pending
listing represents substitutes for which the Agency has not received
complete data or has not completed its review of the data.
After reviewing a substitute, the Agency may make a determination
that a substitute is acceptable only if certain conditions of use are
met to minimize risks to human health and the environment. Such
substitutes are described as ``acceptable subject to use conditions.''
Use of such substitutes without meeting associated use conditions
renders these substitutes unacceptable and subjects the user to
enforcement for violation of section 612 of the Clean Air Act.
Even though the Agency can restrict the use of a substitute based
on the potential for adverse effects, it may be necessary to permit a
narrowed range of use within a sector end-use because of the lack of
alternatives for specialized applications. Users intending to adopt a
substitute acceptable with narrowed use limits must ascertain that
other acceptable alternatives are not technically feasible. Companies
must document the results of their evaluation, and retain the results
on file for the purpose of demonstrating compliance. This documentation
shall include descriptions of substitutes examined and rejected,
processes or products in which the substitute is needed, reason for
rejection of other alternatives, e.g., performance, technical or safety
standards, and the anticipated date other substitutes will be available
and projected time for switching to other available substitutes. Use of
such substitutes in applications and end-uses which are not specified
as acceptable in the narrowed use limit renders these substitutes
unacceptable.
As described in the Final SNAP Rule, EPA does not believe that
rulemaking procedures are required to list alternatives that are
determined to be acceptable with no limitations. Such listings do not
impose any sanction, nor do they remove any prior license to use a
substitute. Consequently, EPA periodically adds substitutes to the list
of acceptable alternatives without first requesting comment on new
listings. Updates to the acceptable and pending lists are published in
separate Notices in the Federal Register.
Also as described in the Final SNAP Rule, EPA believes that notice-
and-comment rulemaking is required to place any alternative on the list
of prohibited substitutes, to list a substitute as acceptable only
under certain use conditions or narrowed use limits, or to remove an
alternative from either the list of prohibited or acceptable
substitutes. In this interim final rule, however, EPA is listing HFP
and HFP-containing blends as unacceptable in all refrigeration and air-
conditioning end-uses, without prior notice and comment. The reasons
for the Agency's decision to do so in an interim final rule rather than
in a notice-and-comment rulemaking are discussed in section D below.
D. Necessity for Interim Final Rule
Section 307(d)(3) of the Clean Air Act (CAA or the Act) states that
in the case of any rule to which section 307(d) applies, notice of
proposed rulemaking must be published in the Federal Register. The
promulgation or revision of regulations under Title VI of the CAA
(relating to stratospheric ozone protection) is generally subject to
section 307(d). However, section 307(d) does not apply to any rule
referred to in subparagraph (A) or (B) of section 553(b) of the
Administrative Procedure Act (APA), 5 U.S.C. 551 et seq.
APA section 553(b) requires that any rule to which it applies be
issued only after the public has received notice of, and an opportunity
to comment on, the rule. However, APA section 553(b)(B) exempts from
those requirements any rule for which the issuing agency for good cause
finds that providing prior notice-and-comment would be impracticable,
unnecessary or contrary to the public interest. Thus, any rule for
which EPA makes such a finding is exempt from the notice-and-comment
requirements of both APA section 553(b) and CAA section 307(d).
EPA believes that the circumstances presented here provide good
cause to
[[Page 3867]]
take the actions set forth in this final rule without prior notice and
comment, since providing prior notice and comment would be
impracticable and contrary to the public interest. Specifically, EPA is
concerned about health risks to workers associated with the use of HFP
in replacement refrigerant formulations, in light of recently reviewed
toxicity data concerning HFP. The data indicate that typical worker
exposure levels for HFP are above minimal levels of concern for
noncancer risks. Exposures to HFP have been shown to lead to kidney
damage. As a result, when HFP is used as a refrigerant or as a
component in a refrigerant blend, there is a significant chance that
persons who manufacture, service or dispose of refrigeration and air-
conditioning equipment that contains HFP or an HFP blend may be exposed
to levels that put them at risk of kidney damage, particularly if they
have not been specifically trained in the handling of HFP or of blends
containing HFP. Moreover, since HFP has not historically been used in
refrigeration equipment, refrigerant technicians generally are not
trained to handle HFP or HFP blends. Thus, any persons servicing or
disposing of refrigeration and air-conditioning units that use an HFP-
containing blend would be subject to an actual and immediate health
risk. The Agency believes that there is a real threat of exposure.
Several parties have made submissions of HFP-containing
refrigerants under the SNAP program and the 90-day prohibition on
marketing has expired. Thus, EPA is concerned that refrigerant blends
that contain HFP may currently be commercially available and in actual
use around the nation. As a consequence, the Agency believes that good
cause exists to take the actions set forth in this final rule without
prior notice and comment in order to mitigate the risk of exposure to
this toxic substance.
As stated in section 612 of the Act, one of the Agency's objectives
in implementing the SNAP program is to promulgate rules making it
unlawful to replace any class I or class II substance with any
substitute that EPA determines may present adverse effects to human
health or the environment. The Agency believes that HFP and HFP-
containing blends present an unacceptable risk to human health, and
that immediate action by EPA is necessary in order to mitigate any
resulting harm. The use of HFP in the refrigeration and air-
conditioning sector will come to a halt most quickly through the
publication of this interim final rule. In addition, this action,
combined with Agency outreach and communication efforts, should provide
any current or potential users of HFP or HFP-containing blends with
immediate notice that EPA does not consider HFP to be an appropriate
compound to use in the refrigeration and air-conditioning sector and
that potential health risks are associated with exposure to HFP during
the manufacture and servicing of any refrigeration and air-conditioning
equipment that contains HFP. A full notice-and-comment rulemaking would
defeat the regulatory objective of the SNAP program to fully ensure
protection of human health.
Nonetheless, EPA is providing 30 days for submission of public
comments following today's action. EPA will consider all written
comments submitted in the allotted time period to determine if any
change to this action is necessary.
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, if an Agency identifies a good cause, APA
section 553(d)(3) allows a rule to take effect earlier, provided that
the Agency publishes its reasoning in the final rule. Since EPA has
determined that good cause exists to list HFP and HFP-containing blends
as unacceptable as a replacement refrigerant, EPA is making this action
immediately effective in order to ensure the fullest protection of
human health.
II. Listing of HFP and HFP-Containing Blends as Unacceptable
As noted above, in light of information recently reviewed by EPA
concerning the toxicity of HFP, EPA is greatly concerned about the use
of HFP in replacement refrigerant formulations. EPA has completed an
HFP risk screen, a copy of which is available in the docket, which
indicates that its use as a refrigerant or in refrigerant blends will
pose an unacceptable risk to anyone exposed to HFP during the
manufacture or servicing of refrigeration or air-conditioning equipment
that contains HFP or an HFP-containing blend. Because of the extremely
low occupational exposure limit for HFP, and the fact that worker
exposure levels for HFP were predicted to be above levels of concern
for noncancer risks, HFP should not be used in the refrigeration and
air conditioning sector. It should be noted that today's determination
has no bearing on the use of HFP or any blend that contains HFP, other
than as a replacement for a class I or class II substance in the
refrigeration and air-conditioning sector. Other industrial sectors may
have safeguards in place to protect against worker exposure to HFP.
Based on the review of the available toxicity information related to
HFP, and the results of the EPA risk screen, EPA is today listing HFP
and all HFP-containing blends as unacceptable for all refrigeration and
air-conditioning end-uses, whether as substitutes for a class I
substance such as CFC-12, or as substitutes for a class II substance
such as HCFC-22.
III. Summary of Supporting Analyses
A. Unfunded Mandates Reform Act and Regulatory Flexibility Act
Since this action is not subject to notice-and-comment rulemaking
requirements under the APA or any other law, it is also not subject to
sections 202, 204 or 205 of the Unfunded Mandates Reform Act (UMRA). In
addition, since this action does not impose annual costs of $100
million or more on small governments or uniquely affect small
governments, the Agency has no obligations under section 203 of UMRA.
Moreover, since this action is not subject to notice-and-comment
requirements under the APA or any other statute as stated above, it is
not subject to section 603 or 604 of the Regulatory Flexibility Act.
B. Executive Order 12866: Review of Significant Regulatory Actions by
OMB
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether this regulatory action is ``significant''
and therefore subject to Office of Management and Budget (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.
OMB has determined that this rule is not a ``significant regulatory
action'' within the meaning of the Executive Order.
[[Page 3868]]
C. Paperwork Reduction Act
EPA has determined that this final rule contains no information
requirements subject to the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq., that are not already approved by the Office of Management and
Budget (OMB). OMB has reviewed and approved two Information Collection
Requests by EPA which are described in the March 18, 1994 rulemaking
(59 FR 13044, at 13121, 13146-13147) and in the October 16, 1996
rulemaking (61 FR 54030, at 54038-54039). The OMB Control Numbers are
2060-0226 and 2060-0350.
D. Executive Order 12875: Enhancing Intergovernmental Partnerships
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 any 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 regulatory proposals containing significant unfunded mandates.''
Today's rule does not create a mandate upon any State, local, or
tribal governments. The 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 rule.
E. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, EPA submitted 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
General Accounting Office prior to publication of the rule in today's
Federal Register. This rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
F. Executive Order 13045: Children's Health Protection
This final rule is not subject to E.O. 13045, entitled Protection
of Children from Environmental Health Risks and Safety Risks (62 FR
19885, April 23, 1997), because it does not involve decisions on
environmental health risks or safety risks that may disproportionately
affect children.
G. Executive Order 13084: Consultation and Coordination with Indian
Tribal Governments
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies on matters
that significantly or uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. The rule does not impose any
enforceable duties on these entities. Accordingly, the requirements of
section 3(b) of Executive Order 13084 do not apply to this rule.
H. National Technology Transfer and Advancement Act
The National Technology Transfer and Advancement Act of 1995
(NTTAA), Sec. 12(d), Pub. L. 104-113, requires federal agencies and
departments to use the technical standards that are developed or
adopted by voluntary consensus standards bodies, using such technical
standards as a means to carry out policy objectives or activities
determined by the agencies and departments. If use of such technical
standards is inconsistent with applicable law or otherwise impractical,
a federal agency or department may elect to use technical standards
that are not developed or adopted by voluntary consensus standards
bodies if the head of the agency or department transmits to the Office
of Management and Budget an explanation of the reasons for using such
standards.
This proposed rule does not mandate the use of any technical
standards; accordingly, the NTTAA does not apply to this rule.
IV. Additional Information
For copies of the comprehensive SNAP lists or additional
information on SNAP, contact the Stratospheric Protection Hotline at 1-
800-296-1996, Monday-Friday, between the hours of 10:00 a.m. and 4:00
p.m., Eastern Time.
For more information on the Agency's process for administering the
SNAP program or criteria for evaluation of substitutes, refer to the
SNAP final rule published in the Federal Register on March 18, 1994 (59
FR 13044). Notices and rules published under the SNAP program, as well
as EPA publications on protection of atmospheric ozone, are available
from EPA's Ozone World Wide Web site at http://www.epa.gov/ozone/
title6/snap, and from the Stratospheric Protection Hotline number
listed above.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.
Dated: January 19, 1999.
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. Sec. 7414, 7601, 7671-7671q.
2. Subpart G is amended by adding Appendix F to read as follows:
Subpart G--Significant New Alternatives Policy Program
* * * * *
Appendix F to Subpart G--Unacceptable Substitutes Listed in the
Janaury 26, 1999 Final Rule, Effective Janaury 26, 1999
[[Page 3869]]
Refrigeration and Air-Conditioning Sector UnacceptabLe Substitutes
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End-use Substitute Decision Comments
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All refrigeration and air- Hexafluoropropylene Unacceptable........ Presents unacceptable toxicity
conditioning end uses. (HFP) and all HFP- risk.
containing blends.
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[FR Doc. 99-1765 Filed 1-25-99; 8:45 am]
BILLING CODE 6560-50-P
