Protection of Stratospheric Ozone; Acceptable Substitutes for the Significant New Alternatives Policy (SNAP) Program

Federal RegisterJul 28, 1995

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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.

-----------------------------------------------------------------------

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

------------------------------------------------------------------------

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.

------------------------------------------------------------------------

Refrigeration and Air Conditioning--Pending Decisions

------------------------------------------------------------------------

Application Substitute Comments

------------------------------------------------------------------------

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.

------------------------------------------------------------------------

Foam Blowing--Pending Substitutes

------------------------------------------------------------------------

End-use Substitute Comments

------------------------------------------------------------------------

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.

------------------------------------------------------------------------

Fire Suppression and Explosion Protection--Acceptable Substitutes

------------------------------------------------------------------------

End-use Substitute Decision Comments

------------------------------------------------------------------------

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.

------------------------------------------------------------------------

Fire Suppression and Explosion Protection Pending Substitutes

------------------------------------------------------------------------

End-use Substitute Comments

------------------------------------------------------------------------

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.

------------------------------------------------------------------------

Solvent Cleaning--Pending Substitutes

------------------------------------------------------------------------

End-use Substitute Comments

------------------------------------------------------------------------

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).

------------------------------------------------------------------------

Sterilants--Acceptable Substitutes

------------------------------------------------------------------------

End-use Substitute Decision Comments

------------------------------------------------------------------------

12/88 CFC-12/Ethylene Peroxyacetic Acceptable.....

Oxide. Acid/Hydrogen

Peroxide Gas

Plasma Systems.

Sterilants........... Hydrogen Acceptable.....

Peroxide Gas

Plasma Systems.

------------------------------------------------------------------------

Sterilants--Pending Substitutes

------------------------------------------------------------------------

End-use Substitute Comments

------------------------------------------------------------------------

12/88 CFC-12/Ethylene HFC-125/EtO............ Awaiting FIFRA

Oxide. registration.

Sterilants............. HFC-227ea/EtO.......... Awaiting FIFRA

registration.

------------------------------------------------------------------------

Aerosols--Pending Substitutes

------------------------------------------------------------------------

End-use Substitute Comments

------------------------------------------------------------------------

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.

------------------------------------------------------------------------

[[Page 38734]]

[FR Doc. 95-18617 Filed 7-27-95; 8:45 am]

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