[Federal Register Volume 60, Number 145 (Friday, July 28, 1995)]
[Rules and Regulations]
[Pages 38729-38734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18617]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-5266-4]
Protection of Stratospheric Ozone; Acceptable Substitutes for the
Significant New Alternatives Policy (SNAP) Program
AGENCY: Environmental Protection Agency.
ACTION: Notice of acceptability.
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SUMMARY: This notice expands the list of acceptable substitutes for
ozone depleting substances (ODSs) under the Environmental Protection
Agency's (EPA) Significant New Alternatives Policy (SNAP) program. SNAP
implements section 612 of the amended Clean Air Act of 1990, which
requires EPA to evaluate substitutes for the ODSs, and regulate the use
of substitutes where other alternatives exist that reduce overall risk
to human health and the environment. Through these evaluations, SNAP
generates lists of acceptable and unacceptable substitutes for each of
the major industrial use sectors.
On March 18, 1994, EPA promulgated its plan for administering the
SNAP program, and issued decisions on the acceptability and
unacceptability of a number of substitutes (59 FR 13044). In today's
Notice, EPA issues decisions on the acceptability of substitutes not
previously reviewed by the Agency. The intended effect of this action
is to expedite movement away from ozone depleting compounds. To arrive
at determinations on the acceptability of substitutes, the Agency
completed a cross-media sector end-use screening assessment of risks to
human health and the environment.
EFFECTIVE DATE: July 28, 1995.
ADDRESSES: Information relevant to this notice is contained in Air
Docket A-91-42, Central Docket Section, South Conference Room 4, U.S.
Environmental Agency, 401 M Street SW., 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.
FOR FURTHER INFORMATION CONTACT: Jeffrey Levy at (202) 233-9727 or fax
(202) 233-9577, U.S. EPA, Stratospheric Protection Division, 401 M
Street SW., Mail Code 6205J, Washington, D.C. 20460.
SUPPLEMENTARY INFORMATION:
I. Section 612 Program
A. Statutory Requirements
B. Regulatory History
II. Listing of Acceptable Substitutes
A. Refrigeration and Air Conditioning
B. Fire Suppression and Explosion Protection
C. Medical Sterilants
III. Substitutes Pending Review
IV. Additional Information
Appendix A: Summary of Acceptable and Pending Decisions
Section 612 Program
Statutory Requirements
Section 612 of the Clean Air Act authorizes EPA to develop a
program for evaluating alternatives to ozone-depleting substances. EPA
is referring 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 38730]]
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 6
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.
Regulatory History
On March 18, 1994, EPA published the Final Rulemaking (FRM) (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.
As described in the final rule for the SNAP program (59 FR 13044),
EPA does not believe that rulemaking procedures are required to list
alternatives as acceptable with no limitations. Such listings do not
impose any sanction, nor do they remove any prior license to use a
substance. Consequently, EPA is adding substances to the list of
acceptable alternatives without first requesting comment on new
listings.
EPA does, however, believe that notice-and-comment rulemaking is
required to place any substance on the list of prohibited substitutes,
to list a substance as acceptable only under certain conditions, to
list substances as acceptable only for certain uses, or to remove a
substance from either the list of prohibited or acceptable substitutes.
Updates to these lists are published as separate notices of rulemaking
in the Federal Register.
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 substitute manufacturers, but may include
importers, formulators or end-users, when they are responsible for
introducing a substitute into commerce.
EPA published Notices listing acceptable alternatives on August 26,
1994, and January 13, 1995, and published a Notice of Proposed
Rulemaking restricting the use of certain substitutes on September 26,
1994.
II. Listing of Acceptable Substitutes
This section presents EPA's most recent acceptable listing
decisions for substitutes for class I substances in the following
industrial sectors: refrigeration and air conditioning, foam blowing,
fire suppression and explosion protection; sterilants. These decisions
represent substitutes not previously reviewed and add to the lists of
acceptable substitutes under SNAP. For copies of the full list, contact
the EPA Stratospheric Protection Hotline at the number listed in
Section IV of this Notice.
Parts A through C below present a detailed discussion of the
substitute listing determinations by major use sector. Tables
summarizing listing decisions in this Notice are in Appendix A. The
comments contained in Appendix A provide additional information on a
substitute, but like the listings themselves, are not regulatory in
nature. Thus, adherence to recommendations in the comments are not
mandatory for use of a substitute. In addition, the comments should not
be considered comprehensive with respect to other legal obligations
pertaining to the use of the substitute. However, EPA encourages users
of acceptable substitutes to apply all comments to their use of these
substitutes. In many instances, the comments simply allude to sound
operating practices that have already been identified in existing
industry and/or building-code standards. Thus, many of the comments, if
adopted, would not require significant changes in existing operating
practices for the affected industry.
A. Refrigeration and Air Conditioning
Please refer to the final SNAP rule for detailed information
pertaining to the designation of end-uses, additional requirements
imposed under sections 608 and 609, and other information related to
the use of alternative refrigerants.
1. Acceptable
a. Volatile Methylsiloxanes. Octamethylcyclotetrasiloxanes and
decamethylcyclopentasiloxanesare acceptable as substitutes for CFC-11,
CFC-12, CFC-113, CFC-114, CFC-115 in new and retrofitted heat transfer
systems. This class of compounds was reviewed under the risk screen for
solvent cleaning and was found acceptable. That end-use is generally
more emissive than heat transfer uses. Thus, EPA anticipates that VMS
will pose lower risk in this end-use.
b. Water. Water is acceptable as a substitute for CFC-11, CFC-12,
CFC-113, CFC-114, and CFC-115 in new and retrofitted heat transfer
systems.
c. Mineral Oil. Mineral oil is acceptable as a substitute for CFC-
11, CFC-12, CFC-113, CFC-114, and CFC-115 in new and retrofitted heat
transfer systems. Mineral oil has been used for decades as a heat
transfer fluid. It is low in toxicity and poses no ozone depletion or
global warming potentials. Note that local fire codes may contain
requirements related to the use of mineral oil.
d. R-508. R-508, which contains HFC-23 and R-116, is acceptable as
a substitute for CFC-13, R-13B1, and R-503 in retrofitted and new
industrial process refrigeration. Both components of this blend exhibit
extremely high GWPs and long lifetimes. HFC-23 has a GWP of 9,000 and a
lifetime of 280 years, and R-116, perfluoroethane, has a GWP of 9,000
and a lifetime of 10,000 years. EPA believes this blend could
significantly contribute to global warming if allowed to escape
refrigeration systems. In addition, the long lifetimes of R-116 and
HFC-23 mean any global warming or other effects would be essentially
irreversible. While the current rule issued under section 608 of the
CAA does not require recycling and recovery of this blend, or leak
repair for systems using it, EPA strongly encourages users to
anticipate future rulemakings with voluntary compliance. In particular,
EPA urges users to reduce leakage and recover and recycle this blend
during equipment
[[Page 38731]]
servicing and upon the retirement of equipment. This blend is
nonflammable and does not deplete ozone.
e. Ammonia Absorption. Ammonia absorption is acceptable as an
alternative technology to household refrigerators and freezers using
CFC-12 as a refrigerant. This technology has been used for years in
hotels, college dormitories, and other small spaces.
B. Fire Suppression and Explosion Protection
1. Acceptable
a. Total Flooding Agents. (1) Water Mist Using Potable Water or
Natural Seawater. Water Mist Systems using Potable Water or Natural
Seawater are acceptable as a Halon 1301 substitute. At EPA's request,
manufacturers of water mist systems and other industry partners
convened a medical panel to address questions posed by EPA concerning
the potential physiological effects of inhaling very small water
droplets in fire and non-fire scenarios. Disciplines represented on the
Panel included inhalation toxicology, pulmonary medicine, physiology,
aerosol physics, fire toxicity, smoke dynamics, and chemistry, with
members coming from the commercial, university and military sectors.
The Executive Summary (draft ``Water Mist Fire Suppression Systems
Health Hazard Evaluation;'' HARC, US Army, NFPA; March 1995) states:
``The overall conclusion of the Health Panel's review is that ... water
mist systems using pure water do not present a toxicological or
physiological hazard and are safe for use in occupied areas. The Panel
does not believe that additional studies are necessary to reach this
conclusion. The Health Panel recommends that additives be evaluated on
a case-by-case basis depending on the toxic properties of the additive
and the concentration at which it is used.''
EPA has determined that the Panel's findings are credible and
significant, and thus is adopting its conclusions as the basis to this
ruling. In order to clarify the practical meaning of the panel's
recommendation, EPA is defining ``pure water'' as either water that is
potable (drinkable) or as natural seawater, that is, water coming from
the sea. Thus, EPA is listing water mist systems composed of potable
water and natural sea water as acceptable without restriction. However,
water mist systems containing additives different than those in potable
water, and water mist systems comprised of mixtures in solution, must
be submitted to EPA for SNAP review on a case-by-case basis. At this
time, no such submissions have been received by the agency.
(2) [Water Mist/Surfactant Blend] A. [Water Mist/Surfactant Blend]
A is acceptable as a Halon 1301 substitute in normally unoccupied
areas. Water mist systems with additives are beginning to be developed
for use in applications such as the engine compartments of a variety of
vehicles and in machinery spaces. Following the positive peer review of
water mist particles, and considering the particular use in unoccupied
areas, EPA is listing this agent as acceptable in such normally
unoccupied areas. Consideration for use in occupied areas is pending a
medical peer review panel.
b. Streaming Agents. (1) Water Mist Systems Using Potable Water or
Natural Seawater. Water Mist systems using potable water or natural sea
water are acceptable as a Halon 1211 substitute. See the discussion
under ``Total Flooding Agents,'' above.
C. Medical Sterilants
1. Acceptable
(a) Peroxyacetic Acid/Hydrogen Peroxide Gas Plasma Systems.
Peroxyacetic Acid/Gas Plasma Systems are acceptable as a 12/88
substitute for medical sterilization. Peracetic acid/hydrogen peroxide
solutions are in widespread use as sanitizers and disinfectants in food
processing establishments and medical facilities. As they are currently
manufactured, transported, and handled safely, incorporation of such
solutions into medical sterilizing equipment should not pose increased
risk of exposure either during value-added packaging or during use.
(b) Hydrogen Peroxide Gas Plasma Systems. Hydrogen Peroxide Gas
Plasma Systems are acceptable as a 12/88 substitute for medical
sterilization. Such systems are recognized by the Food and Drug
Administration (FDA) as acceptable to proceed to market, and EPA has
determined that they pose no unusual risk to human health or the
environment.
III. Substitutes Pending Review
The Agency describes submissions as pending if data are incomplete
or for which the 90-day review period is underway and EPA has not yet
reached a final decision. For submissions that are incomplete, the
Agency will contact the submitter to determine a schedule for providing
the missing information if the Agency needs to extend the 90-day review
period. EPA will use its authority under section 114 of the Clean Air
Act to gather this information, if necessary. Any delay of the review
period does not affect a manufacturer's ability to sell a product 90
days after notification of the Agency. Substitutes currently pending
completion of review are listed in Appendix A.
IV. Additional Information
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
Standard Time) weekdays.
For more information on the Agency's process for administering the
SNAP program or criteria for evaluation of substitutes, refer to the
SNAP final rulemaking published in the Federal Register on March 18,
1994 (59 FR 13044). Federal Register notices can be ordered from the
Government Printing Office Order Desk (202) 783-3238; the citation is
the date of publication. This Notice can also be retrieved
electronically from EPA's Technology Transfer Network (TTN), Clean Air
Act Amendment Bulletin Board. If you have a 1200 or 2400 bps modem,
dial (919) 541-5742. If you have a 9600 bps modem, dial (919) 541-1447.
For assistance in accessing this service, call (919) 541-5384. Finally,
this notice may be obtained on the World Wide Web at http://
www.epa.gov/docs/Ozone/index.html.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.
Dated: July 18, 1995.
Mary D. Nichols,
Assistant Administrator.
Note: The following Appendix will not appear in the Code of
Federal Regulations.
[[Page 38732]]
Appendix A: Summary of Acceptable and Pending Decisions
Refrigeration and Air Conditioning--Acceptable Substitutes
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End-use Substitute Decision Comments
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CFC-11, CFC-12, CFC- Volatile Methyl Acceptable.
113, CFC-114, CFC- Siloxanes.
115 Non-Mechanical
Heat Transfer
(Retrofit and New
Equipment Designs/
NIKs).
Water.......... Acceptable.
Mineral Oil.... Acceptable.
CFC-13, R-13B1, and R- R-508.......... Acceptable..... EPA strongly
503 Industrial recommends the
Process containment
Refrigeration and and
Very Low Temperature reclamation of
Refrigeration this
(Retrofit and New substitute.
Equipment/NIKs).
CFC-12 Household Ammonia Acceptable.
Refrigerators and absorption.
Freezers, New
Equipment/NIKs.
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Refrigeration and Air Conditioning--Pending Decisions
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Application Substitute Comments
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All CFC-12 End-Uses.. Blend Zeta........... EPA has requested
additional data.
Heat Transfer........ HCFC-225.
Motor Vehicle Air R-406A, HCFC Blend MVAC refrigerants will be
Conditioning. Delta. used in accordance with
use conditions, which
require full notice-and-
comment rulemaking.
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Foam Blowing--Pending Substitutes
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End-use Substitute Comments
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HCFCs, Polyurethane and HFC-134a/HFC-143a
Polyisocyanurate Blend.
Laminated Boardstock
Foam.
HCFCs, Rigid HFC-134a/HFC-143a
Polyurethane Appliance Blend.
Foam.
HCFCs, Rigid HFC-134a/HFC-143a
Polyurethane Blend.
Commercial
Refrigeration, Spray
and Sandwich Panel
Foam.
HCFCs, Rigid HFC-134a/HFC-143a
Polyurethane Slabstock Blend.
and Other Foam.
HCFCs, Polyolefin Foams HFC-134a/HFC-143a
Blend.
HCFCs, Polyurethane HFC-134a/HFC-143a
Flexible Foams. Blend.
HCFCs, Polyurethane HFC-134a/HFC-143a
Integral Skin. Blend.
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Fire Suppression and Explosion Protection--Acceptable Substitutes
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End-use Substitute Decision Comments
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Halon 1211, Water Mist Systems Acceptable........
Streaming Agents. using Potable or
Natural Sea Water.
Halon 1301......... Water Mist Systems Acceptable........
using Potable or
Natural Sea Water.
Total Flooding [Water Mist Acceptable in
Agents. Surfactant Blend] Normally
A. Unoccupied Areas.
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Fire Suppression and Explosion Protection Pending Substitutes
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End-use Substitute Comments
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Halon 1211........... CF3I................. Will be proposed
acceptable in
nonresidential
applications in a
forthcoming rulemaking.
Streaming Agents..... HFC-227ea............ Complete SNAP submission
and personal monitoring
data required.
[Water Mist/ Pending review by EPA
Surfactant Blend] A.
Water Mist with Must be individually
Additives. submitted to EPA and
reviewed on a case-by-
case basis.
Halon 1301........... [HFC Blend] A........ Pending receipt of further
data requested by the
Agency.
Total Flooding Agents IG-55 (formerly Proposed Acceptable
[Inert Gas Blend] B). (forthcoming).
IG-01 (formerly Proposed Acceptable
[Inert Gas Blend] C). (forthcoming).
[[Page 38733]]
[Water Mist Pending peer review for
Surfactant Blend] A. use in normally occupied
areas.
Water Mist Systems Must be individually
with Additives. submitted to EPA and
reviewed on a case-by-
case basis. No
submissions have been
received to date.
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Solvent Cleaning--Pending Substitutes
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End-use Substitute Comments
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Metals cleaning w/ HCFC-122............. Agency is still reviewing
CFC-113, MCF, and ODP. This HCFC is a new
HCFC-141b. chemical and must also
complete Premanufacture
Notice requirements under
the Toxic Substances
Control Act.
HFC-4310mee.......... SNAP/Premanufacture Notice
review under the Toxic
Substances Control Act
nearly completed.
Electronics cleaning Perfluoropolyethers.. Agency evaluating global
w/ CFC-113, MCF and warming concerns.
HCFC-141b.
Electronics cleaning Perfluorocarbons Agency in process of
w/ HCFC-141b. (C5F12, C6F12, evaluating global warming
C6F14, C7F16, C8F18, concerns.
C5F11NO, C6F13NO,
C7F15NO, and C8F16).
Precision cleaning w/ HCFC-122............. Agency is still reviewing
CFC-113, MCF. ODP. This HCFC is a new
chemical and must also
complete Premanufacture
Notice requirements under
the Toxic Substances
Control Act.
HFC-4310mee.......... SNAP and Premanufacture
Notice review under the
Toxic Substances Control
Act is nearly completed.
Chlorobromomethane... EPA is completing a more
detailed analysis on the
range of ODP for this
substitute and is
reviewing updated
information on the
toxicity of this
substitute.
Precision cleaning w/ Perfluorocarbons Agency in process of
HCFC-141b. (C5F12, C6F12, evaluating global warming
C6F14, C7F16, C8F18, concerns.
C5F11NO, C6F13NO,
C7F15NO, and C8F16).
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Sterilants--Acceptable Substitutes
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End-use Substitute Decision Comments
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12/88 CFC-12/Ethylene Peroxyacetic Acceptable.....
Oxide. Acid/Hydrogen
Peroxide Gas
Plasma Systems.
Sterilants........... Hydrogen Acceptable.....
Peroxide Gas
Plasma Systems.
------------------------------------------------------------------------
Sterilants--Pending Substitutes
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End-use Substitute Comments
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12/88 CFC-12/Ethylene HFC-125/EtO............ Awaiting FIFRA
Oxide. registration.
Sterilants............. HFC-227ea/EtO.......... Awaiting FIFRA
registration.
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Aerosols--Pending Substitutes
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End-use Substitute Comments
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CFC-11, HCFC-22, and SF6.................. Review nearly completed;
HCFC-142b. extremely high GWP is
major consideration.
Compressed gas a viable
alternative.
CFC-113, MCF, HCFC- HCFC-225............. EPA evaluating feasibility
141b as solvents. of controling
occupational exposures
during use.
Volatile methyl EPA evaluating feasibility
siloxanes. of controling
occupational exposures
during use.
Perfluoropolyethers.. EPA evaluating global
warming concerns.
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[FR Doc. 95-18617 Filed 7-27-95; 8:45 am]
BILLING CODE 6560-50-P