Protection of Stratospheric Ozone; Final Rule ENVIRONMENTAL PROTECTION AGENCY

SUMMARY: This final rule promulgates the U.S. Environmental Protection

Agency's (EPA) program for evaluating and regulating substitutes for

ozone-depleting chemicals being phased out under the stratospheric

ozone protection provisions of the Clean Air Act (CAA). In section 612

of the CAA, the Agency is authorized to identify and restrict the use

of substitutes for class I and II ozone-depleting substances where the

Administrator has determined that other alternatives exist that reduce

overall risk to human health and the environment. EPA is referring to

the program that provides these determinations as the Significant New

Alternatives Policy (SNAP) program. The intended effect of this final

rule is to expedite movement away from ozone-depleting compounds by

identifying substitutes that offer lower overall risks to human health

and the environment.

In this final rule, EPA is both issuing decisions on the

acceptability and unacceptability of substitutes and promulgating its

plan for administering the SNAP program. To arrive at determinations on

the acceptability of substitutes, the Agency completed a crossmedia

analysis of risks to human health and the environment from the use of

various substitutes in different industrial end-uses. Results of this

analysis are summarized in this final rule, which covers substitutes in

the following sectors: Refrigeration and air conditioning, foam

blowing, solvents cleaning, fire suppression and explosion protection,

tobacco expansion, adhesives, coatings and inks, aerosols, and

sterilants. Analysis of substitutes in a ninth sector, pesticides, will

be completed, and the resulting decisions will be added to future SNAP

determinations published in the Federal Register. These sectors

comprise the principal United States industrial sectors that

historically consumed large volumes of ozone-depleting compounds.

EFFECTIVE DATE: This rule is effective on April 18, 1994.

ADDRESSES: Materials relevant to the rulemaking are contained in Air

Docket A-91-42, Central Docket Section, South Conference room 4, U.S.

Environmental Protection Agency, 401 M Street SW., Washington, DC

20460. The docket may be inspected between 8 a.m. and 12 noon, and from

1:30 p.m. and 3:30 p.m. on weekdays. As provided in 40 CFR part 2, a

reasonable fee may be charged for photocopying.

Notifications, petitions or other materials required by this final

rule should be sent to: SNAP Coordinator, U.S Environmental Protection

Agency, (6205-J), 401 M Street SW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: The Stratospheric Ozone Information

Hotline at 1-800-296-1996 can be contacted for information on weekdays

from 10 a.m. to 4 p.m. Eastern Time or contact Sally Rand at (202) 233-

9739, Substitutes Analysis and Review Branch, Stratospheric Protection

Division, Office of Atmospheric Programs, Office of Air and Radiation

(6205-J), 401 M Street SW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION: In this preamble, EPA describes the final

SNAP program in sections III through VIII. Although EPA may include

responses to certain comments throughout the description of the

program, readers should see section III.D. for a discussion of EPA's

responses to public comment on major issues. See also the Response to

Comment document found in Docket A-91-42 for a detailed response to

comments on all issues.

I. Overview of Final Rule

This final rule is divided into eleven sections, including this

overview:

I. Overview of Final Rule.

II. Background.

A. Regulatory History.

B. Subgroup of the Federal Advisory Committee.

III. Section 612 Program.

A. Statutory Requirements.

B. Guiding Principles.

C. Implementation Strategy.

D. Response to Public Comment.

IV. Scope of Coverage.

A. Definition of Substitute.

B. Who Must Report.

V. Information Submission.

A. Overview.

B. Information Required.

C. Submission of Confidential Business Information.

D. Display of OMB Control Numbers.

VI. Effective Date of Coverage.

A. General Provisions.

B. Grandfathered Use of Unacceptable Substitutes.

VII. Notice, Review, and Decision-Making Procedures.

A. Substitutes Reviewed under SNAP Only.

B. Joint Review of New Substitutes under SNAP and the Toxic

Substances Control Act Premanufacture Notice (TSCA PMN) Program.

C. Joint Review of Substitutes under SNAP and the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA).

D. Shared Statutory Authority with the Food and Drug

Administration (FDA).

VIII. Petitions.

A. Background.

B. Content of the Petition.

C. Sufficiency of Data.

D. Criteria for Evaluating Petitions.

E. Petition Review Process.

IX. Listing of Substitutes.

A. Overview.

B. Format for SNAP Determinations.

C. Decisions Universally Applicable.

D. Refrigeration and Air Conditioning.

E. Foam Blowing.

F. Solvents Cleaning.

G. Fire Suppression and Explosion Protection.

H. Sterilants.

I. Aerosols.

J. Tobacco Expansion.

K. Adhesives, Coatings and Inks.

X. Additional Information.

XI. References.

Appendix A: Class I and Class II Ozone-Depleting Substances.

Appendix B: Summary of Listing Decisions.

Appendix C: Data Confidentiality Claims.

II. Background

A. Regulatory History

The stratospheric ozone layer protects the earth from dangerous

ultraviolet-B (UV-B) radiation. Depletion of stratospheric ozone allows

more UV-B radiation to penetrate to the earth's surface. Increased

radiation, in turn, has been linked to higher incidence of certain skin

cancers and cataracts, suppression of the human immune system, damage

to crops and aquatic organisms, and increased formation of ground-level

ozone. Further, increased radiation can cause economic losses from

materials damage such as more rapid weathering of outdoor plastics.

(See 53 FR 30566 (August 12, 1988) for more information on the effects

of ozone depletion.)

In response to scientific concerns and findings on ozone depletion,

the United States and twenty-three other nations signed the Montreal

Protocol on Substances that Deplete the Ozone Layer on September 16,

1987. The original agreement set forth a timetable for reducing the

production and consumption of specific ozone-depleting substances,

including CFC-11, CFC-12, CFC-113, CFC-114, CFC-115, Halon 1211, Halon

1301, and Halon 2402. EPA implemented the original Protocol through

regulations allocating production and consumption allowances equal to

the total amount of production and consumption granted to the United

States under the Protocol. (See 53 FR 30566.)

The Parties to the Montreal Protocol met in London June 27-29, 1990

to consider amendments to the Protocol. In response to scientific

evidence indicating greater than expected stratospheric ozone

depletion, the Parties agreed to accelerate the phaseout schedules for

the substances already controlled by the Protocol. They also added

phaseout requirements for other ozone-depleting chemicals, including

methyl chloroform, carbon tetrachloride, and other fully-halogenated

chlorofluorocarbons (CFCs).

On November 15, 1990, then-President Bush signed the Clean Air Act

Amendments (CAAA) of 1990. Title VI, section 604 of the amended CAA

requires a phaseout of CFCs, halons, and carbon tetrachloride by 2000,

which is identical to the London Amendments to the Montreal Protocol,

but with more stringent interim reductions. Title VI also differs from

the London Amendments by mandating a faster phaseout of methyl

chloroform (2002 instead of 2005), a restriction on the use of

hydrochlorofluorocarbons (HCFCs) after 2015, and a ban on the

production of HCFCs after 2030. In Title VI, section 602, the CFCs,

halons, carbon tetrachloride, and methyl chloroform are defined as

class I substances; HCFCs are referred to as class II substances.

Appendix A of this final rule lists the class I and class II substances

identified in the CAA.

In addition to the phaseout requirements, Title VI includes

provisions to reduce emissions of class I and II substances to the

``lowest achievable level'' in the refrigeration sector and to maximize

the use of recycling and recovery upon disposal (section 608). It also

requires EPA to ban certain nonessential products containing ozone-

depleting substances (section 610); establish standards and

requirements for the servicing of motor vehicle air conditioners

(section 609); mandate warning labels on products made with or

containing class I or containing class II substances (section 611); and

establish a safe alternatives program (section 612). The development

and implementation of the safe alternatives program under section 612

is the subject of this final rule.

In October 1991, the National Aeronautics and Space Administration

(NASA) announced new findings documenting ozone depletion over the last

decade that was more severe than had previously been predicted by

atmospheric modeling or measurements. In particular, NASA found 2.9

percent ozone depletion over the northern mid-latitudes over the past

decade in summertime--the first time a trend showing ozone depletion

had been detected in the U.S. during that time of year, when risks from

depletion are greatest.

Partly in response to these findings, on February 11, 1992, then-

President Bush announced an accelerated phaseout schedule for class I

substances as identified in the CAA, as amended, section 606. This

final schedule, published in the Federal Register (58 FR 65018;

December 10, 1993), implements a January 1, 1996 phaseout of class I

chemicals. The President also ordered an accelerated review of

substitutes that reduce damage to the ozone layer. The expedited

phaseout schedule and the President's directive regarding alternatives

added urgency to EPA's effort to review and list substitutes for class

I and II substances under section 612.

B. Subgroup of the Federal Advisory Committee

In 1989, EPA organized the Stratospheric Ozone Protection Advisory

Committee (STOPAC) in accordance with the requirements of the Federal

Advisory Committee Act, 5 U.S.C. app. section 9(c). The STOPAC

consisted of members selected on the basis of their professional

qualifications and diversity of perspectives and provided

representation from industry, academia, federal, state, and local

government agencies, non-governmental and environmental groups, as well

as international organizations. The purpose of STOPAC was to provide

advice to the Agency on policy and technical issues related to the

protection of stratospheric ozone.

In 1991, the Agency asked STOPAC members to participate in

subgroups to assist in developing regulations under title VI of the

CAA. EPA established a subgroup of the standing STOPAC to guide the

Agency specifically on development of the safe alternatives program.

The subgroup on safe alternatives met twice. At the first meeting in

May 1991, subgroup members reviewed a detailed description of EPA's

plans for implementing section 612. At this meeting, there was general

agreement on the need to issue a request for data to provide the

general public with an opportunity to furnish the Agency with

information on substitutes. The group also agreed on the need to review

substitutes as quickly as possible to avoid any delay in industry's

efforts to phase out ozone-depleting substances.

At the second meeting of the subgroup, in July 1991, subgroup

members provided EPA with comments on a draft of the Advance Notice of

Proposed Rulemaking (ANPRM), which was prepared in response to the

conclusions of the first meeting. The comments focused primarily on the

draft discussion of EPA's plans for implementing section 612 and

refinements to a list of preliminary substitutes that the Agency

intended to review. Based on comments received from the subgroup and

other offices within EPA, a final ANPRM was prepared and published in

the Federal Register on January 16, 1992 (57 FR 1984). Because the bulk

of regulatory development required under title VI has been completed,

the STOPAC has since been disbanded.

III. 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

is referring to this new 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 or class II 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.

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.

B. Guiding Principles

EPA has followed several guiding principles in developing the SNAP

program:

1. Evaluate Substitutes Within a Comparative Risk Framework

The Agency's risk evaluation compares risks of substitutes to risks

from continued use of ozone-depleting compounds as well as to risks

associated with other substitutes. This evaluation considers effects

due to ozone depletion as well as effects due to direct toxicity of

substitutes. Other risk factors considered include effects on water and

air quality, the potential for direct and indirect contributions to

global warming, and occupational health and safety. Any effects found

to pose a concern will be evaluated further to determine if controls

are required. EPA does not believe that a numerical scheme producing a

single index to rank all substitutes based on risks is appropriate. A

strict quantitative index would not allow for sufficient flexibility in

making appropriate risk management decisions that consider issues such

as the quality of information supporting the decision, the degree of

uncertainty in the data, the availability of other substitutes, and

economic feasibility.

2. Do Not Require That Substitutes Be Risk-Free To Be Found Acceptable

Section 612(c) requires the Agency to publish a list of acceptable

and unacceptable substitutes. The Agency interprets this as a mandate

to identify substitutes that reduce risks compared to use of class I or

II compounds or to other substitutes for class I or II substances,

rather than a mandate to list as acceptable only those substitutes with

zero risks. In keeping with this interpretation, the Agency believes

that a key goal of the SNAP program is to promote the use of

substitutes for class I and II chemicals that minimize risks to human

health and the environment relative to other alternatives. In some

cases, this approach may involve designating a substitute acceptable

even though the compound may be toxic, or pose other environmental risk

of some type, provided its use reduces overall risk to human health and

the environment as compared to use of class I or class II substances or

other potential substitutes.

3. Restrict Only Those Substitutes That are Significantly Worse

As a corollary to the above point, EPA does not intend to restrict

a substitute if it poses only marginally greater risk than another

substitute. Drawing fine distinctions concerning the acceptability of

substitutes would be extremely difficult given the variability in how

each substitute can be used within a specific application and the

resulting uncertainties surrounding potential health and environmental

effects. The Agency also does not want to intercede in the market's

choice of available substitutes, unless a substitute has been proposed

or is being used that is clearly more harmful to human health and the

environment than other alternatives.

4. Evaluate Risks by Use

Section 612 requires that substitutes be evaluated by use.

Environmental and human health exposures can vary significantly

depending on the particular application of a substitute. Thus, the risk

characterizations must be designed to represent differences in the

environmental and human health effects associated with diverse uses.

This approach cannot, however, imply fundamental tradeoffs with respect

to different types of risk to either the environment or to human

health. For example, in the Agency's consideration of global warming as

a criterion under SNAP, EPA has principally compared different global

warming gases among themselves, as opposed to attempting to establish

some methodology for comparing directly the effects of global warming

and ozone depletion.

5. Provide the Regulated Community With Information as Soon as Possible

The Agency recognizes the need to provide the regulated community

with information on the acceptability of various substitutes as soon as

possible. Given this need, EPA has decided to expedite the review

process by conducting initial risk screens for the major substitutes

now known to the Agency and to include them in this final rulemaking.

Future determinations on the acceptability of new substitutes will be

published in quarterly updates to the SNAP lists.

6. Do Not Endorse Products Manufactured by Specific Companies

While the goal of the SNAP program is to identify acceptable

substitutes, the Agency will not issue company-specific product

endorsements. In many cases, the Agency may base its analysis on data

received on individual products, but the addition of a substitute to

the acceptable list based on that analysis does not represent

endorsement of that company's products. Generally, placement on the

list merely constitutes an acknowledgement that a particular product

made by a company has been found to be acceptable under SNAP.

7. Defer to Other Environmental Regulations When Warranted

In some cases, EPA and other federal agencies have developed

extensive regulations under other statutes or other parts of the CAA

that address any potential cross- or inter-media transfers that may

result from the use of alternatives to class I and II substances. For

example, ceasing to use an ozone-depleting compound may in some cases

entail increased use of chemicals that contribute to tropospheric air

pollution. These chemicals, such as volatile organic compounds (VOCs)

or hazardous air pollutants (HAPs), are already regulated under other

sections of the CAA, and determinations under the SNAP program will

take these existing regulations into account. Where necessary, the

Office of Air and Radiation will confer with other EPA program offices

or federal agencies to ensure that any regulatory overlap is handled

efficiently.

C. Implementation Strategy

Implementation of the SNAP program is directed towards fulfilling

the general policy contained in section 612 of identifying substitutes

that can serve as replacements for ozone depleting substances,

evaluating their effects on human health and the environment, and

encouraging the use of those substitutes believed to present lower

overall risks relative both to the ozone depleting compounds being

replaced and to other substitutes available for the same end-use.

Implementation of this policy involves four key activities. The first

is to develop, promulgate, and administer a regulatory program for

identifying and evaluating substitutes. The second activity is to

undertake a review of the existing substitutes based on criteria

established for the program and then to publish a list of acceptable

and unacceptable substitutes by application. The third activity is to

review additional substitutes as they are developed to allow their

timely introduction into the marketplace. The fourth is to aggressively

disseminate information about those substitutes found to pose lower

overall risk through a clearinghouse and outreach program.

To expedite implementation of the SNAP program, EPA has not only

developed a screening process for examining the alternatives, as

discussed in this final rule, but has also completed an analysis of

many key substitutes based on the criteria presented here. Section IX

summarizes the results of this assessment. More detail on the steps

leading up to this final rule and the implementation of the SNAP

program is given below.

1. ANPRM and Request for Data

On January 16, 1992, EPA published in the Federal Register an

Advance Notice of Proposed Rulemaking (ANPRM) and Request for Data (57

FR 1984). The ANPRM described in general terms EPA's plans for

developing the SNAP program and solicited public comment on the

Agency's planned approach. The ANPRM also included an appendix listing

substitutes that the Agency planned to include in its initial

substitute determinations. The ANPRM invited industry to submit

information on these substitutes and to identify additional

alternatives to be considered in the SNAP program. The Agency received

approximately one hundred comments from industry, trade groups, and

other federal agencies. These comments contained information on

potential substitutes for ozone-depleting chemicals, as well as

comments on the SNAP program as described in the ANPRM.

2. Notice of Proposed Rulemaking on SNAP Process and Proposed

Determinations

On May 12, 1993 EPA published in the Federal Register a Notice of

Proposed Rulemaking (NPRM) for SNAP (58 FR 28094). The NPRM described

the proposed structure and process for administering the SNAP program

and proposed determinations on the acceptability of key substitutes.

The Notice also contained the proposed regulatory language that would

serve as the legal basis for administering and enforcing the SNAP

program.

In the NPRM, EPA recognized that notice-and-comment rulemaking

procedures were necessary to establish regulations governing SNAP. EPA

further concluded that rulemaking was required to place any substance

on the list of unacceptable substances, to list a substance as

acceptable only with certain use restrictions, or to remove a substance

from either the list of unacceptable or acceptable substitutes. EPA did

not believe, however, that rulemaking procedures were required to list

alternatives as acceptable with no restrictions. Such listings would

not impose any sanction, nor remove any prior license to use a

substance.

3. Final Rulemaking

This final rule promulgates the SNAP process and the first set of

determinations on SNAP substitutes. The Agency may revise these

decisions in the future as it reviews additional substitutes and

receives more data on substitutes already covered by the program.

However, EPA expects future changes to the SNAP lists to be minor, and

thus not to represent an undue burden on the regulated community. The

principal changes the Agency expects to make in the future are to add

new substitutes or sectors to the lists, rather than to change a

substitute's acceptability. Further, once a substitute has been placed

on either the acceptable or the unacceptable list, EPA will conduct

notice-and-comment rulemaking to subsequently remove a substitute from

either list, as described below in section VII. This final rule also

addresses comments that the Agency received on the NPRM, and

incorporates further data on substitutes received during the comment

period.

4. Updates of SNAP Determinations

Three mechanisms exist for revising or expanding the list of SNAP

determinations published in this final regulation. First, under section

612(d), the Agency will review and either grant or deny petitions to

add or delete substances from the SNAP list of acceptable or

unacceptable alternatives. Section VIII of this final rule presents

EPA's method for handling petitions.

The second means of revising or expanding the list of SNAP

determinations is through the notifications, described below, which

must be submitted to EPA 90 days before introduction of a substitute

into interstate commerce for significant new use as an alternative to a

class I or class II substance. These 90-day notifications are required

by section 612(e) of the CAA for producers of alternatives to class I

substances for new uses and by EPA regulations issued under sections

114 and 301 of the Act to implement section 612(c) in all other cases.

Section VII of this final rule discusses the Agency's approach for

processing these notifications, including a strategy for integrating

SNAP notifications with other chemical review programs already being

implemented by EPA under authorities provided in the Toxic Substances

Control Act (TSCA) and the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA). Other parts of this final rule also explain

how the Agency addresses the overlap between SNAP regulations and

regulations issued under other titles of the CAA.

Finally, the Agency believes that section 612 authorizes it to

initiate changes to the SNAP determinations independent of any

petitions or notifications received. These amendments can be based on

new data on either additional substitutes or on characteristics of

substitutes previously reviewed.

5. Outreach and Substitute Clearinghouse

Public outreach and the substitute information clearinghouse

comprise the technical assistance component of the SNAP program. The

purpose of this effort is to provide information for the public to use

in selecting acceptable substitutes. Sections VII.A.3.f. and VII.A.3.g

describe the Agency's approach for establishing the clearinghouse and

performing outreach.

D. Response to Public Comment

A document summarizing public comment on the NPRM in greater detail

is available in the public docket supporting this final rule. The major

programmatic issues raised by the commenters and the Agency's response

to them are described below. Major comments specific to the eight SNAP

industry sectors are addressed in sections IX.D. through IX.K. of this

final rule.

1. Scope of the SNAP Rule

a. Class II substances. One commenter supported EPA's position that

the Agency has the authority to review class II substances under SNAP,

particularly EPA's view that where little reduction in ozone depletion

potential (ODP) can be gained in going from a class I substance to a

class II substance, such as from methyl chloroform to HCFC-141b, the

substitution should be disallowed under SNAP. Other commenters

criticized this position, arguing that the omission of any reference to

class II substitutes in section 612(e) clearly indicated Congressional

intent that class II substitutes not be subject to the SNAP program.

For this final rule, the Agency is including class II substances

under the scope of SNAP. The Agency disagrees with one commenter's

interpretation of the limitation in section 612(e). Section 612(c)

specifically mandates that the Agency list unacceptable and acceptable

alternatives for class I or II substances. In addition, the Agency

believes that Congressional intent under section 612 is to reduce the

overall risk from the continued use of ozone depleting substances

(ODSs). The class II substances range in ozone depletion potential

(ODP) from 0.11 for HCFC-141b to 0.02 for HCFC-123. In the evaluation

of substitutes completed for the NPRM, use of some class II substitutes

up to the time of their phaseout was identified as representing

significantly greater overall risk than use of other alternatives

available for a number of end-uses. Consequently, the Agency believes

lower overall risk to human health and the environment can be achieved

by including class II substitutes in SNAP. Despite the limitation in

section 612(e) to producers of class I substances, EPA believes it has

authority under section 114 and section 301(a) to require submission of

SNAP notifications with respect to class II substances as necessary to

enable EPA to carry out its obligation under section 612 to evaluate

both class I and class II substances, as explained in the NPRM.

b. Review of existing versus new substitutes. A number of

commenters believed that EPA's SNAP program has no authority to

restrict existing substitutes, which companies may have switched to in

an effort to eliminate the use of CFCs prior to the publication of this

final rule. Arguments in support of this position include the

prospective language of the statute, which says EPA must make it

``unlawful to replace'' an ODS with a substitute deemed unacceptable.

Many of these commenters recommended grandfathering of these existing

uses, so as not to disrupt industry's transition away from ODSs. An

extension of this concern appears in several comments, in which

commenters expressed the fear that SNAP will revisit prior decisions,

removing substitutes previously deemed acceptable as newer and more

environmentally benign substitutes are developed.

Under the Agency's interpretation of section 612, in order to

fulfill the Congressional mandate to review ``any'' substitute

substance that may present adverse effects to human health and the

environment, both new and existing substitutes must be included under

SNAP. In addition, section 612(e) specifically requires notifying the

Agency before new or existing chemicals are introduced into interstate

commerce. EPA believes that class I and II substances are ``replaced''

within the meaning of section 612(c) each time a substitute is used, so

that once EPA identifies an unacceptable substitute, any future use of

such substitute is prohibited. Under any other interpretation, EPA

could never effectively prohibit the use of any substitute, as some

user could always start to use it prior to EPA's completion of the

rulemaking required to list it as unacceptable. EPA believes Congress

could not have intended such a result, and must therefore have intended

to cover future use of existing substitutes.

c. Grandfathering in SNAP. Many commenters supported the idea of

grandfathering uses of existing substitutes, but felt that the

grandfathering should be broadened to include existing uses of all

substitutes which companies have invested in prior to the promulgation

of the SNAP final rule, and not just HCFC-141b as proposed in the NPRM.

Commenters argued that not doing so would delay transition by creating

uncertainty about the useful life of alternatives.

One commenter argued that the grandfathering scheme EPA has

proposed with respect to HCFC-141b should be extended to existing uses

of perfluorocarbons (PFCs). The commenter notes that title VI calls for

regulation and elimination of ozone-depleting substances while in the

commenter's opinion precluding regulation based on global warming

potential. Since PFCs have no ozone depletion potential, the commenter

argued that they are a better candidate than HCFC-141b for

grandfathering. One commenter proposed two years past the date of an

unacceptability determination as the general grandfathering period.

In this final rule, the Agency will not grandfather existing uses

except in specifically identified cases. The grandfathering provisions

under SNAP do give the Agency flexibility to address unacceptable

listings that might disrupt industry's transition away from ODSs. For

this final rule, the Agency was not presented with significant evidence

from the public comments to believe universal grandfathering of

existing substitutes is warranted. The Agency believes that given the

diversity of the industries covered under the SNAP program, a case-by-

case review of applications using the banned substitute would be

necessary to protect human health and the environment. Moreover, EPA

must be able to justify any grandfathering on a case-by-case basis

under the grandfathering criteria established in the Sierra Club case,

as described below in section VI.B.

In the case of HCFC-141b, the Agency has elected to maintain the

proposed grandfathering period for existing uses, since many users

switched to HCFC-141b when it was believed to offer sufficient risk

reduction. In comparison, for perfluorocarbons, the Agency has made

clear from the beginning of their suggested use as substitutes that the

Agency has concerns about the global warming potential of these

chemicals. EPA believes, therefore, that an extended grandfathering

period in this case is not warranted.

However, the Agency agrees to grandfather for use, existing

supplies of a substitute in the possession of an end-user as of March

18, 1994. Therefore, persons who transitioned to a substitute for an

end-use prior to this final rule may continue use of all existing

supplies of the substitute purchased prior to March 18, 1994 until that

supply is exhausted. As of the effective date of this final rule, only

substitutes purchased prior to March 18, 1994 can be used. Under the

four-part test to judge the appropriateness of grandfathering (see

section VI.B of this final rule), the Agency determined that, on

balance, the results of this test favors this action.

Existing inventory of final products manufactured with or

containing a substitute designated unacceptable as a result of final

EPA rule-making within an end-use covered under SNAP could

theoretically be legally sold after listing. Producers should be aware,

however, that they will be effectively barred from selling a substitute

for use once it has been deemed unacceptable under SNAP, because

potential purchasers will not be able to use it. After the effective

date of this final rule, users will not be able to use any additional

supply of a banned substitute purchased after the publication date of

the unacceptable listing.

d. Exemption for small sectors and small volume uses. In the NPRM,

EPA proposed to exempt small volume use applications requiring less

than 10,000 pounds per year of an ODS substitute from SNAP review. This

proposal generated substantial confusion. Many commenters pointed out

that the 10,000 pounds exemption from reporting and review under SNAP

was vague, and asked for additional clarification. Specifically,

commenters asked whether EPA intended the 10,000 pound limit to apply

at the process, plant, company, or sector level. If applied at the

sector level, some commenters noted that an individual end-user might

have enormous difficulty compiling volume information related to the

behavior of an entire industry sector.

In response to these comments, EPA has decided to maintain the

small use exemption but provide the needed additional clarification of

the Agency's intent. The Agency will exempt from the section 612(e)

notification requirements substitutes used in quantities of 10,000

pounds or less per year within a major industrial sector covered under

SNAP. The responsibility for reporting under the notification

requirement for SNAP falls on those introducing substitutes into

interstate commerce, not on the individual end-user. Similarly, relief

from reporting, if within the bounds of the small use and sector

exemption as defined, rests with the same person.

The Agency believes the burden of responsibility for determining

whether use of a substitute will be small should reside at the same

level as the notification requirement. That is, it should be the

responsibility of the introducing agent to determine whether use of a

particular substitute in a given sector is likely to remain below

10,000 pounds per year. The Agency continues to believe that focusing

the listing decisions on the substitutes sold in the largest volumes

will allow the Agency to target its regulatory efforts to those

applications that offer the maximum risk reduction potential.

Many commenters generally supported EPA's exemption for small

industrial sectors, arguing that the administrative burden imposed by a

SNAP review of all possible substitutions is unjustified by the likely

risks posed by these uses. For this final rule, the Agency will

continue to exempt small sectors and small volume uses within major

industrial sectors from reporting responsibilities under SNAP.

e. Designation of submitters/reporting responsibilities. Many of

the public comments on the NPRM expressed general support for the

flexibility of the reporting requirements, noting it is sensible to

require notification from the person most suited to have the relevant

information. However, some confusion has arisen as to the

implementation and enforcement of these requirements.

The Agency agrees with public comment that the designation of

submitters or reporting responsibility needed clarification in this

final rule. For this final rule then, reporting responsibility rests

with the person who introduced the substitute into interstate commerce

in its final form. As such, the producer could potentially be a

manufacturer, formulator, or an end-user. Identification of designated

submitters is further detailed in section IV.B.

f. Exemption for second-generation substitutes. Many commenters

supported EPA's exemption for second-generation substitutes. However,

several asked for clarification of regulatory language setting out this

exemption. They note that the definition left plenty of room for

advances in the science to calculate increasingly small contributions

to ozone depletion added by hitherto unsuspected compounds, thereby

constantly broadening the scope of SNAP as new concerns develop. They

ask that EPA clarify that SNAP should only apply to substitutes for

class I or class II compounds.

EPA agrees with these comments and has clarified in section

IV.A.2.f. that the definition of second-generation applies only to

substitutes for class I or class II compounds in this final rule.

2. SNAP Determination and Listing Process

a. Allowing for assured minimum periods of use. Numerous commenters

expressed a need for a minimum assured time period of use for

acceptable substitutes in order to facilitate the fastest possible

transition away from class I substances. Some commenters suggested that

this assured minimum period should be established based on some

economic measure, such as the lifetime of equipment in which the

compound is to be used, or the overall payback period for investment in

modifications to allow the use of a transitional compound. One

commenter suggested the use of risk analysis to define the assured

minimum period. Other commenters suggested 10 years as the appropriate

period.

The Agency believes Congress enacted provisions under section 612

which make a minimum assured time period for use of a substitute

neither authorized nor necessary under SNAP. As described in section

VIII of this final rule, a petition under section 612(d) to change a

listing from acceptable to unacceptable or vice versa must include

adequate data. In addition, any change will be formally promulgated as

a rulemaking, which requires EPA to propose, take public comment, and

complete final action for any decision. If the decision is made to

change a listing for a substitute from acceptable to unacceptable, the

grandfathering provisions of this final rule provide the Agency with

the flexibility in appropriate cases to provide time after a substitute

is removed from the list of acceptable substitutes to allow persons who

are then using the substance, or who have expended considerable efforts

in good faith toward its use, to find a different substitute and

recover their investment in prior substitutes.

3. SNAP Information Form

a. Use of global warming potential. Some commenters argue that EPA

has no legal authority under section 612 to regulate substitutes based

on global warming. One commenter noted that during the development of

title VI, Congress deliberately excised global warming from the

statute, and that legislative history of title VI thus argues against

reliance on global warming as a regulatory criterion under SNAP.

Finally, a commenter asserted that not only the Congress, but the

President also believes that ozone depletion and global warming should

be treated separately.

The Agency believes that the Congressional mandate to evaluate

substitutes based on reducing overall risk to human health and the

environment authorizes use of global warming as one of the SNAP

evaluation criteria. Public comment failed to identify any definition

of overall risk that warranted excluding global warming. Further, in

October 1993, the President directed EPA through the Climate Change

Action Plan (CCAP) to use its authority under section 612 of the Clean

Air Act to narrow the uses allowed for hydrofluorocarbons and

perfluorocarbons with high global warming potential.

EPA disagrees with the statutory and legislative history arguments

raised by the commenter. The commenter points to language that relates

only to the listing of ozone depleting and global warming substances,

which is not relevant to EPA's authority under section 612(c) to

regulate substitutes based on an assessment of overall risk. The fact

that Congress may have deleted authority for EPA to phase out use of

substances based solely on their global warming potential without

regard to available substitutes certainly imposes no limitation on

consideration of global warming potential as a factor in assessing the

overall risk of using any class I or II substitute. Especially in light

of President Clinton's recent commitment to use section 612 authority

specifically to narrow uses of high global warming potential CFC

substitutes based on an overall risk assessment, EPA has concluded that

it is appropriate to consider global warming potential as one factor in

the SNAP analysis. Therefore, in this final rule, the Agency will

continue to exercise its statutory authority to review substitutes for

listing as unacceptable or acceptable alternatives, using the criteria

for evaluation set out in the NPRM, including global warming.

4. Definitions

a. Definition of potentially available. Several commenters

supported EPA's definition of potentially available because it would

speed the review process and encourage innovation in development of new

substitutes. Other commenters expressed the concern that EPA's

definition of ``potentially available'' could allow EPA to review and

accept a substitute which may be several years from general commercial

availability, and on that basis to ban some other commonly used

chemical with relatively higher risk. These commenters argued that EPA

should at least wait until test marketing has begun to consider an

alternative ``potentially available'' for the purpose of SNAP review.

Another commenter argued that a knowledge of the economic viability of

a substitute is crucial in assessing its potential availability as a

substitute under SNAP.

Under section 612(c) of the CAA, the Agency is specifically

required to identify alternatives that are either ``currently or

potentially available.'' For this final rule, the Agency is defining as

potentially available any alternative for which adequate health,

safety, and environmental data, as required for the SNAP notification

process, exist to make a determination of acceptability, and which the

Agency reasonably believes to be technically feasible, even if not all

testing has yet been completed and the alternative is not yet produced

or sold. EPA would not prohibit use of a substitute where no substitute

that reduces overall risk is currently available, to avoid situations

where the only available substitute to allow transition away from

ozone-depleting compounds is unacceptable under SNAP.

b. Definition of a substitute. Several commenters expressed support

for EPA's definition of a substitute as used in the NPRM. One commenter

proposed the use of the word ``alternative'' instead of ``substitute,''

while supporting the Agency's general construction of the statute to

allow SNAP's purview to extend beyond chemical substitutes to a broader

range of alternative technologies, including process changes. Another

commenter, while also generally supporting EPA's definition of a

substitute, pointed out that the language ``could replace'' is overly

broad. This commenter noted that this language suggests that someone

who is not using a compound as an ODS replacement, but is aware that it

could be used in this way, should report to EPA under SNAP.

For the purpose of this final rule the Agency is using the word

``substitute'' as a synonym for alternative. As discussed in section

IV.A, this definition includes chemical substitutes, alternative

manufacturing processes, and alternative technologies. In response to

the public comment described above, the Agency has also clarified in

this final rule that SNAP addresses only those substitutes or

alternatives actually replacing the class I and II compounds listed

under section 602 of the CAA within the eight industrial sectors

identified in sections IX.D. through K.

5. General Comments on Substitutes

a. Perfluorocarbons. Under the NPRM for SNAP, EPA proposed

perfluorocarbons (PFCs) as acceptable for limited use as replacements

for ozone depleting chemicals in the solvent cleaning, and fire

suppression and explosion protection sectors. Several commenters

supported the Agency's cautious approach toward PFCs, given the high

global warming potential of these compounds as well as their extreme

atmospheric persistence. Other commenters sought clarification with

respect to the scope of the Agency's proposed restrictions on PFCs.

PFCs are fully fluorinated compounds, unlike CFCs, HCFCs, or

hydrofluorocarbons (HFCs). These chemicals are nonflammable, have low

toxicity, are exempt from federal VOC regulations, and do not

contribute to stratospheric ozone depletion. The environmental

characteristics of concern for these compounds are high global warming

potential (5,000-10,000 times greater than CO2) and long

atmospheric lifetimes (3,000-5,000 years). Although the actual

contributions to global warming depend upon the quantities emitted,

because of their long atmospheric lifetimes, the warming effects of

PFCs are essentially irreversible.

In the proposed rule, EPA identified specific solvent cleaning

applications for which PFCs were acceptable. In response to public

comment seeking clarification of these limitations, EPA is finding PFC

use acceptable in electronics and precision cleaning for only high-

performance, precision-engineered applications where no other

substitute for CFC-113 or MCF would meet performance or safety

requirements. Additional detail on PFC use in the solvent cleaning

sector can be found in section IX.F.

In this final rule, EPA has also clarified the limitations placed

in its proposed rule on the use of PFCs to replace halons. PFC-410

(C4F10) and PFC-614 (C6F14) will be limited to fire

suppression and explosion protection applications where other

alternatives are not technically feasible to meet safety or performance

requirements due to the physical or chemical properties of the agent,

or where human exposure to the extinguishing agent may approach

cardiosensitization levels or result in other unacceptable health

effects under normal operating conditions. Additional detail on PFC use

in the fire suppression and explosion protection sector can be found in

section IX.G.

Before replacing ozone-depleting compounds with PFCs, users must

first investigate whether other alternatives would meet performance or

safety standards. This may include contacting vendors or testing using

other substitutes and equipment. Although special forms or reporting to

EPA is not required, companies must maintain documentation of the

review of alternatives on file. Where users must rely on PFCs for lack

of other options, they should make every effort to adopt closed systems

and recover, recycle and destroy the chemicals where possible. EPA also

encourages PFC users to reduce emissions to a minimum through

conservation practices that address idling losses and operator

variables. Above all, PFC users should continue the search for long-

term alternatives.

IV. Scope of Coverage

A. Definition of Substitute

1. Statutory Language

Based on the language of section 612(a) of the CAA, the Agency

defines within the SNAP program a ``substitute'' as any chemical,

product substitute, or alternative manufacturing process, existing or

new, that could replace a class I or II substance. While subsequent

subsections of section 612 refer only to ``substitute substances'' or

``substitute chemicals,'' EPA interprets these provisions for purposes

of the SNAP program as incorporating the general definition of

substitute presented in section 612(a). The Agency believes that this

definition is consistent with the overall intent of section 612 and is

necessary to enable EPA to identify and analyze the universe of

substitutes for class I and II substances.

Section 612(c) prohibits users from replacing class I or II

substances with any substitute substance which the Administrator

determines may present adverse effects to human health and the

environment, where the Administrator has identified an alternative to

such replacement that: (1) Reduces overall risk to human health and the

environment, and (2) is currently or potentially available. EPA

believes that in addition to authorizing the Agency to ban the use of a

given substitute substance where other alternatives exist, section 612

confers the legal authority to allow the use of a substance only with

certain restrictions--conditions of use or narrowed use limits--while

banning its use otherwise. This authority is inherent in the

Administrator's authority to totally ban use of the substitute where

other acceptable alternatives exist that reduce overall risk. EPA only

intends to use this authority where a viable substitute exists that

would otherwise have to be disallowed because of risk associated with

its uncontrolled use.

a. Use conditions. In imposing conditions on use, EPA does not

intend to preempt other regulatory authorities, such as those exercised

by the Occupational Safety and Health Administration (OSHA) or other

government or industrial standard-setting bodies. Rather, EPA hopes to

fill existing regulatory gaps during the interim period of substitution

away from ozone-depleting compounds and provide the needed margin of

protection to human health and the environment until other regulatory

controls or standards are developed under appropriate authorities.

EPA anticipates applying use conditions only in the rare instances

where clear regulatory gaps exist, and where an unreasonable risk would

exist in the absence of any condition. These restrictions will remain

in place only until the appropriate standard-setting agency acts. Where

appropriate, EPA's use conditions will terminate by their own terms

once the appropriate standard-setting Agency takes action. The

mechanism for informing the public of this change will be the quarterly

Federal Register notices updating the status of the SNAP lists. These

are discussed further in Section VII.A below.

b. Narrowed use limits. In imposing narrowed use limits, the Agency

has sought to expand the list of alternatives available to all

applications within a sector end-use category. EPA recognizes that

certain sector end-uses encompass a broad range of applications,

manufacturing processes, and products. Where EPA narrows uses, a

substitute will be acceptable for use only in certain applications, as

where other alternatives are not technically feasible due to

performance or safety requirements. Conditions on use discussed in

section IV.A.1.a. above refer to how (under what operating conditions)

an otherwise unacceptable substitute may be used; narrowed use limits

define where (in which end-uses and applications) an otherwise

unacceptable substitute may be used.

c. Potentially available. Section 612(e) makes clear that a

chemical can be a substitute whether it is existing or new. Also, the

language in section 612(c) clearly states that a new substitute may be

currently or potentially available. In this final rule, the Agency is

defining as potentially available any alternative for which adequate

information exists to make a determination of acceptability, and which

the Agency reasonably believes to be technically feasible, even if not

all testing has yet been completed and the substitute is not yet

produced and sold.

2. Additional Clarification

EPA believes that the statutory language included in section 612 is

written broadly to allow for a reasonably comprehensive evaluation of

substitutes that will be introduced as replacements for ozone-depleting

chemicals. However, additional clarification is presented below to

further explain the Agency's definition of a ``substitute'' in specific

circumstances based on section 612.

a. Chemicals already listed under TSCA. Section 612(e) explicitly

requires producers of chemicals, both new and existing, to notify the

Agency before introducing such chemicals into interstate commerce for

significant new uses as class I alternatives. In addition, section

612(c) requires the Agency to produce lists of acceptable and

unacceptable substitutes, without regard to the status of each chemical

alternative, whether new or existing.

These interrelated provisions of section 612 serve as the basis for

the Agency's belief that all substitutes, whether ``new or existing''

chemicals, should be subject to SNAP review. This regulatory purview

would thus necessarily extend to those chemicals already listed on the

TSCA inventory of existing chemicals. EPA believes SNAP review is

critical for such chemicals given the differing statutory objectives of

TSCA and the CAA, and the new and expanded applications of many

existing chemicals as class I and II replacements, which could alter

existing release and exposure profiles.

b. Significant new use of existing alternatives. There has also

been some question regarding whether an existing alternative already

being sold commercially within a SNAP sector (e.g., use of semi-aqueous

cleaners in the electronics industry) would be subject to review under

section 612. The Agency believes that it should be subject to review

under SNAP. Because of the phaseout, uses of existing substitutes can

reasonably be expected to increase significantly beyond current

consumption, which could translate into greater releases and risks from

use of a substitute. Existing substitutes are therefore subject to SNAP

review because EPA believes that their use can be expected to

significantly expand to new users or product lines. Users should note

that the SNAP determinations discussed in section IX of this final rule

demonstrate that with few exceptions, all substitutes already on the

market meet the conditions for acceptability under the SNAP program.

c. Authority to review substitutes for class II compounds. Section

612(c) authorizes the Administrator to prohibit the use of substitutes

for class II, as well as class I substances, and requires the Agency to

compile lists of substitutes for class II as well as class I compounds

upon making the requisite findings. EPA believes that this is in part

because of the considerable overlap in sectors that use class I and II

substances. More importantly, this mirrors the statute's general

emphasis on moving away from class I compounds in a way that does not

create new and unintended environmental problems. Clearly, for the same

reasons class I substitutes require review under the SNAP program,

class II substitutes should also be reviewed.

To obtain the data necessary to analyze class II substitutes, the

Agency is using statutory authority provided in sections 114 and 301 of

the CAA in conjunction with 612(c). As explained in the NPRM, these

sections, when read together, authorize the Administrator to promulgate

such regulations as needed to require companies to provide information

EPA may reasonably need to identify acceptable and unacceptable

substitutes for class II substances. EPA is exercising this authority

to subject class I and II substitutes to the same information reporting

requirements and listing process.

d. Designation of class I and II chemicals as substitutes. EPA

believes that review authority under section 612 extends also to use of

class I and II chemicals as substitutes, even though these chemicals

are subject to the phaseout provisions of the CAA. While one comment

received by the Agency in response to the NPRM questions EPA's

authority under section 612 to review class I and II chemicals as

substitutes (e.g., methyl chloroform used to replace CFC-113), it is

clear that these compounds can be used as substitutes for other class I

and II substances in certain applications. Since section 612 authority

extends to ``any'' substitutes, both class I and II substances are

subject to review under the SNAP program just as any other substitute.

Given the potential for the class I and II chemicals used as

substitutes for other ozone-depleting chemicals to continue depleting

stratospheric ozone and thus affect human health and the environment, a

close examination of these alternatives in the context of both their

effect on the environment and the availability of other substitutes for

particular uses is especially warranted under section 612.

e. Alternative products and manufacturing processes. EPA believes

that section 612(c) broadly charges EPA to identify alternatives to

ozone-depleting substances. For example, EPA believes that alternative

products can include no-clean fluxes in electronics manufacturing

processes that currently use class I or II compounds as cleaning

solvents. EPA believes it appropriate to consider substitute processes

and products for review under the SNAP program, since many of these

alternatives are viable substitutes and could reduce overall risks to

human health and the environment. EPA believes that such alternative

products and processes, therefore, fall within the definition of

substitutes under section 612.

Similarly, new production techniques and/or processing equipment

are important developments that can minimize environmental releases.

Accordingly, alternative manufacturing processes will also be examined

under section 612 in the context of use and emissions of substitutes.

EPA believes that section 612's reference to ``alternative,'' instead

of ``alternative substance,'' or ``alternative chemical,'' implies a

statutory intent that ``alternative'' be read broadly. This furthers

the statutory desire to shift use to alternatives that reduce overall

risk.

EPA will encourage, where appropriate, alternative processes and

technologies that reduce environmental and human health effects. In

many applications, reliance on alternative processes and/or equipment

may be associated with the use of particular substitute chemicals. In

these instances, EPA encourages the filing of joint submissions where

information is provided by both the chemical manufacturer and, for

example, an equipment manufacturer whose equipment makes use of such a

substitute. Such joint filings will provide the most comprehensive data

on an alternative and its effect on human health and the environment.

f. Second-generation substitutes. A key issue is whether there

exists a point at which an alternative should no longer be considered a

class I or II substitute as defined by section 612. The Agency believes

that as long as class I or II chemicals are being used, any substitute

designed to replace these chemicals is subject to review under section

612. In this final rule, the Agency has determined that second-

generation replacements, if they are non-ozone depleting and are

replacing non-ozone depleting first-generation alternatives, are exempt

from reporting requirements under section 612. Other regulatory

programs (e.g., other sections of the CAA, or section 6 of TSCA) exist

to ensure protection of human health and the environment in these

situations.

Where second-generation substitutes replace first-generation

substitutes that are themselves ozone-depleters (e.g., HCFCs), these

second-generation substitutes are bound by the same notification and

review requirements under section 612 as first-generation substitutes

to ozone-depleting chemicals. For example, if a hydrofluorocarbon (HFC)

is introduced as a first-generation refrigerant substitute for either a

class I (e.g., CFC-12) or class II chemical (e.g., HCFC-22), it is

subject to review and listing under section 612. Future substitutions

to replace the HFC would then be exempt from reporting under section

612 because the first-generation alternative did not deplete

stratospheric ozone. If, however, a class I or class II chemical is

used as a first-generation substitute (e.g., use of HCFC-141b as a

transitional replacement in foam blowing), the second-generation

substitute is still subject to review under section 612 because it is

replacing a class I or class II chemical.

The key to determining whether a substitute is exempt or not as a

second-generation substitute is, as discussed above, what it is

designed to replace. For example, SNAP reviews are not meant to cover

cases in which a technology is designed for use primarily in replacing

existing non-ozone depleting evaporative cooling systems. In general,

if most intended uses for a possible substitute are to replace a non-OD

substitute for a class I or class II substance, then this substance

would therefore be a second-generation substitute, and SNAP review is

unlikely to be required. In those situations where class I or class II

substitutes have already been replaced in most applications, the small

use exemption could also eliminate the need for review of next

generation substitutes.

g. Applicability to existing uses. The prohibition on use of an

alternative applies only to substitutions to unacceptable substitutes

made after the effective date of any final rulemaking for

unacceptability. However, for this final rule, any person who has

transitioned to a substitute for an end-use prior to any SNAP final

rulemaking designating it as unacceptable may continue to use the

substitute until their existing supply of the chemical, as of March 18,

1994, is depleted.

Existing inventory of final products manufactured with or

containing a substitute designated unacceptable as a result of final

EPA rule-making within an end-use covered under SNAP could

theoretically be legally sold after listing. Producers should be aware,

however, that they will be effectively barred from selling a substitute

for use once it has been deemed unacceptable under SNAP, because

potential purchasers will not be able to use it. After the effective

date of this final rule, users will not be able to use any additional

supply of a banned substitute purchased after the publication date of

the unacceptable listing.

h. Substitutes produced outside of the United States. Companies

manufacturing substitutes outside the U.S. who are producing solely for

use by entities outside the U.S. are not subject to the requirements of

these section 612 rules. EPA believes that its authority under section

612 extends only to use of substitutes in areas under the jurisdiction

of the United States government. This principle does not apply to

substitutes introduced as replacements for class I and II chemicals at

offshore U.S. installations (e.g., U.S. military bases located in

foreign countries) that are subject to the legal provisions of section

612.

Substitutes manufactured within the U.S. exclusively for export are

subject to SNAP since the definition of use in the rule includes use in

the manufacturing process, which occurs within the United States.

B. Who Must Report

1. General Provisions

As required by section 612(e), anyone who produces a substitute for

a class I substance must provide the Agency with that person's

unpublished health and safety studies on the substitute, as well as

notify the Agency at least 90 days before introducing the substitute

into interstate commerce for significant new use as an alternative.

Also, as discussed in section IV.A.2.c. of this final rule, pursuant to

sections 114, 301 and 612(c) of the CAA, producers of class II

substitutes must abide by the same reporting requirements. Under the

authority of sections 114, 301(a) and 612(c), EPA has determined that

in certain cases, formulators or end-users of substitutes could be

considered to be producers and would therefore be subject to reporting

requirements. This approach is discussed below, in section IV.B.2. To

analyze substitutes under section 612(c), the Agency finds it necessary

under section 301(a) to require that any person who introduces a

substitute in its final form into interstate commerce be considered to

be a producer of the substitute and required to submit information

describing the substitute under section 114. With respect to

substitutes for both class I and II substances, EPA needs all of the

types of information described below, not just health and safety

studies. Such data are needed to allow EPA to fully analyze the overall

risks to human health and the environment presented by alternative

substitutes, as required by section 612(c).

2. Designated Submitters

Several commenters requested clarification on who has primary

responsibility to notify EPA under SNAP. EPA recognizes that a

potential substitute can be developed for introduction into one of the

SNAP sectors at several points in the manufacture-to-use chain. EPA

considers responsibility for notification under SNAP to reside with the

person who first introduces a substitute not otherwise exempted from

reporting requirements into interstate commerce. Therefore, for

example, if a chemical manufacturer introduces a substitute into

interstate commerce for sale as a fire extinguishing agent to replace

an ODS-based extinguishing method, the manufacturer is a designated

submitter under SNAP. If a system manufacturer or a chemical formulator

buys an agent from a chemical manufacturer and subsequently formulates

or engineers it for introduction into interstate commerce as a

substitute for an ozone-depleting means of fire suppression, then in

this case, the system manufacturer or formulator is the designated

submitter. If an end-user develops a proprietary blend or means of fire

suppression using chemical or physical inputs purchased from

manufacturers or formulators and then enters that product into

interstate commerce as a replacement for ozone-depleting means of fire

suppression, then the end-user is in this case the designated

submitter.

a. Chemical manufacturers. Chemical manufacturers producing a

substitute in its final form are required to notify the Agency of the

existence of that substitute. For instance, if a chemical manufacturer

intends to market a new chemical as a substitute foam blowing agent to

companies that manufacture insulation products, the chemical

manufacturer would be required to notify the Agency about the existence

of the substitute.

b. Formulators. A formulator is engaged in the preparation or

formulation of a substitute, after chemical manufacture of the

substitute or its components, for distribution or use in commerce.

Formulators usually only sell substitutes based on existing chemicals,

since they do not ordinarily possess chemical manufacturing

capabilities. Chemicals used in such substitutes are frequently in

common use and have already been accepted for general use through other

chemical review programs such as under TSCA or FIFRA.

However, to the extent that these formulators can be considered to

be directly responsible for production of the substitute for an end-

use, for example by offering a tailored formulation for an industrial

cleaning process, these formulators would be subject to reporting

requirements as outlined in this final rule. In such cases, the

formulator is best suited in the manufacture-to-use chain to present

information on how substitutes based on existing chemicals are or could

be used. In cases where the manufacturer of a chemical is also the

formulator of a blend, the manufacturer would be responsible for

meeting reporting requirements on the substitute.

The Agency does not foresee a situation where any person who simply

re-packages a substitute, i.e. does not in any way alter the chemical

or physical characteristics of the substitute, would be the designated

submitter. However, if the act of re-packaging a product is intended

solely to allow for the introduction of a substitute into interstate

commerce, that person would be the designated submitter under SNAP.

c. End-users. In general, end-users of substitutes will not be

obligated to meet the reporting requirements discussed in this final

rule, except in rare cases where the end-user and the producer of the

substitute for commercial introduction in final form are the same

person. While the Agency expects that this situation will occur

infrequently, several large companies have developed substitutes for

their own use and subsequently have notified EPA of their intent to

offer those substitutes for commercial sale. Because EPA intends to

require end-users to report only on those substitutes they plan to

introduce into interstate commerce, evaluating and listing such

substitutes will not stifle research and development innovations by

end-users.

3. Exemptions From Reporting

The Agency has identified several situations in which notification

under the provisions of section 612 will not be required. These

exemptions from reporting are discussed below.

a. Substitutes already listed by EPA. As part of this final rule,

the Agency has already completed the review of numerous class I and II

alternatives and has determined that these substitutes are either

acceptable or unacceptable. In preparing these determinations, the

Agency evaluated information either on file or supplied in response to

the NPRM published in the Federal Register on May 12, 1993. The

substitutes list and supporting risk screens are described in more

detail in section IX. No further submission is needed for any of those

substitutes already listed as acceptable or unacceptable in this final

rule. However, further information may be required for those

substitutes listed as pending review in appendix B.

b. Small sectors. Most ozone-depleting substances have been or are

currently used in large industrial sectors such as refrigeration and

air conditioning or foam blowing. However, there are also numerous

small uses of class I or II substances that fall outside of these major

use sectors. While small use applications for class I and II compounds

are varied and numerous, in the aggregate these small uses do not

contribute substantially to ozone depletion. The Agency estimates that

across all sectors these varied but small sector uses comprise in

aggregate at most seven percent of total U.S. consumption of ozone-

depleting substances. For more detail on the Agency's analysis and

rationale for exempting small sectors, readers should refer to the

Notice of Proposed Rulemaking for SNAP (58 FR 28094) published May 12,

1993.

Accordingly, eight major industrial use sectors are covered in this

final rule. They are refrigeration and air conditioning, foam blowing,

fire suppression and explosion protection, solvents cleaning,

adhesives, coatings, and inks, aerosols, sterilization and tobacco

expansion. Analysis of substitutes in a ninth sector, pesticides, will

be completed, and the resulting decisions will be added to future SNAP

determinations published in the Federal Register as part of EPA's

quarterly updates to the lists of acceptable and unacceptable

substitutes. EPA does not plan to add sectors other than the nine

principal sectors listed above to the formal analyses performed under

SNAP, unless the Agency receives additional data indicating that

inclusion of additional sectors is warranted based on the potential for

high risks to human health and the environment due to class I and II

alternatives.

c. Small volume use within SNAP sectors. As noted above, most

ozone-depleting substances have been or are currently used in large

industrial sectors such as refrigeration or fire extinguishing.

However, even within these sectors, the potential for adverse effects

on human health and the environment is related to the aggregate amount

of ozone-depleting material consumed in an end-use. Thus, the Agency is

focusing the SNAP determinations on large-volume uses in the major

industrial sectors. Given the breadth of EPA's required overall risk

assessment, the imposition on small volume uses within any sector of a

requirement for a full SNAP submission seems unjustified by the

potential for risk posed by these small uses.

Moreover, a key policy interest in the SNAP program is promoting

the quickest possible shift from the ODSs into alternatives posing

lower overall risk. The speed and orderliness of this shift depends in

part on clear early determinations from EPA on the acceptability of key

substitutes. Focusing the SNAP program on all possible substitutes in

every conceivable use could diminish EPA's ability to provide an early

and clear message on those substitutes which can contribute most to

solving the problem of general reliance on ozone-depleting chemicals.

Further, the small volume use exemption is an exemption from the

notification requirement only. It does not, for example, authorize the

use in any quantity of a substitute otherwise deemed unacceptable under

SNAP. Since the responsibility for meeting the notification requirement

resides with the person introducing the substitute into interstate

commerce, whether manufacturer, formulator, or end-user, this person is

also responsible for ascertaining whether annual use of the substitute

in its intended sector will exceed 10,000 pounds per year.

Thus, those introducing substitutes for ozone-depleting compounds

in annual quantities of 10,000 pounds per year or less for any given

major industrial sector identified in this rule need not notify EPA of

their activities under SNAP. The exemption applies regardless of

whether the Agency is notified for the same substitute for any

conceivable application in the other major sectors covered under SNAP,

or whether the introducer's total sales are 10,000 pounds or less for

any or all of the other major SNAP sectors.

Those taking advantage of the exemption for small uses must

maintain documentation describing the basis for their view that any

substitute being used meets this small use definition. This

documentation must include annual production and sales information by

sector, and could be necessary in the event the Agency receives a

petition to add such substitutes to its evaluations under SNAP, or to

assure adequate enforcement of the notification requirement.

d. Research and development. Substitutes manufactured or imported

solely for research and development are exempt from reporting

requirements under section 612. Several commenters, including Federal

agencies involved in research on CFC-related substitutes, support this

exemption. Amounts used in research are assumed to be the minimum

necessary for reasonable scientific experimentation. For new chemicals,

the provisions of 720.36 of the PMN rule (40 CFR part 720) are in

effect.

e. Test marketing. Use of alternatives for the sole purpose of test

marketing is exempt from any reporting requirements under section 612.

Persons taking advantage of this exemption, are, however, required to

notify the Agency in writing that they are conducting test marketing

prior to the commencement of sale into interstate commerce.

Notification must be sent 30 days prior to the test marketing period,

and must include the name of the substitute used, the volume used in

the test marketing, and the expected duration of the test marketing.

Once a company decides to sell an alternative as a class I or II

substitute, it must provide the Agency with formal notification at

least 90 days prior to the introduction of the substitute into

interstate commerce for significant new use as a substitute for a class

I or II chemical.

For new substitute chemicals that are being test marketed, the

producer must abide by the provisions of section 5(h)(1) of TSCA, which

authorizes the EPA, upon application, to grant exemptions from TSCA-

reporting requirements, provided that test marketing will not present

an unreasonable risk to human health or the environment.

f. Formulation changes. In general, the Agency believes that

changes in formulation needed to accommodate replacement of class I and

II compounds should not be subject to the provisions of section 612.

Such changes may be necessary, for example, when a new blowing agent in

foam manufacture necessitates the replacement of the catalyst formerly

used with the class I blowing agent. The Agency believes that other

regulatory mechanisms (e.g., TSCA) are available for examining and

controlling, as needed, any adverse environmental and human health

effects associated with subsequent formulation modifications. However,

the manufacturer overseeing the formulation change is required to

notify the Agency if these modifications may significantly influence

the environmental and human health risk characteristics associated with

the class I or II substitute. Also, the Agency reserves the right to

exercise its discretion to examine formulation changes if a problem

appears to exist.

g. Substitutes used as feedstock. Commenters to the NPRM supported

the Agency's proposal to exempt substitutes that could replace class I

chemicals used solely as intermediates in the production of other

chemicals. To the extent that any feedstock substitutions occur, the

Agency believes that they will not contribute substantially to any

incremental risk to human health and the environment. This is because

intermediates are used as inputs in production of other compounds, and

as a result are largely consumed in the chemical manufacturing process.

V. Information Submission

A. Overview

To develop the list of unacceptable and acceptable substitutes for

various end-uses as required by section 612(c), the Agency must assess

and compare the ``overall risks to human health and the environment''

posed by use of substitutes, and this assessment must be performed in

the context of particular applications. To conduct this overall

examination, the Agency must consider a wide range of health and

environmental factors. In order to reduce the burden on the regulated

community, the Agency will defer to data collection requirements under

other regulatory authorities to the maximum extent practicable. In the

section that follows, the Agency presents information required by the

SNAP program to evaluate class I and II substitutes. A copy of the SNAP

Information Notice can be obtained from the SNAP program at the address

listed in the beginning of this final rule.

B. Information Required

1. Name and Description of the Substitute

A chemical substitute should be identified by its chemical name,

trade name(s), identification numbers (e.g. Chemical Abstract Service

(CAS) registry), chemical formula and chemical structure. If a

substitute is a blend, the percentage of each component must also be

provided. Alternative technologies or manufacturing processes should be

described in sufficient detail as to uniquely identify its use as a

class I and II substitute.

2. Physical and Chemical Information

Key properties needed to characterize chemical substitutes include:

molecular weight; physical state; melting point; boiling point;

density; odor threshold; solubility; partition coefficients (Log

Kow, Log Koc); and vapor pressure. For alternative

technologies or manufacturing processes, technical details on health,

environmental or safety issues associated with use should be provided.

3. Substitute Applications

Identification of the end-use in which the substitute is likely to

be used is required. It is essential to provide a complete list of

potential end-uses and of applications within those end-uses because

section 612(c) requires the Agency to list substitutes by specific

uses.

4. Process Description

For each identified end-use application, the Agency requires

descriptive data on processing, including in-place pollution controls.

Such information will be used to characterize workplace and

environmental releases and exposures.

5. Ozone Depletion Potential

The predicted 100-year ozone depletion potential (ODP) of

substitute chemicals relative to CFC-11 is required. The submitter

should also provide sufficient supporting documentation--either a

citation or the background information used to develop the ODP. For

purposes of calculating ODP, the Agency recommends the methodology used

in the most recent Scientific Assessment of Ozone Depletion: 1991,

which was prepared for the United Nations Environment Programme. (1)

6. Global Warming Potential

The Agency requires data on the potential total global warming of

the substitute in its particular end-use (e.g., as a refrigerant, foam

blowing agent, etc.). The total global warming considers both direct

and indirect impacts. Direct impacts refer to the direct contribution

to global warming of using a substitute. Calculation of the global

warming potential (GWP) index for a 100, 500, and 1000 year time

horizon, as well as the atmospheric lifetime and infrared adsorption

spectrum of the substitute used to calculate the GWP is required. The

Agency is requesting that all GWPs be referenced to CO2 using the

methodology recommended by the Intergovernmental Panel for Climate

Change (IPCC).(2) Indirect impacts explicitly consider the effect on

global warming arising from changes in energy consumption associated

with the use of a substitute (e.g., an alternative refrigerant). This

latter measure can be identified as changes in energy efficiency

resulting from use of the substitute relative to that of the substance

being replaced.

7. Toxicity Data

To assess the overall risks to human health and the environment,

information is required on the acute and chronic toxicity of a

substitute chemical, its impurities, and its degradation products on

any organism (e.g., humans and other mammals, fish, wildlife, and

plants). To characterize the risk to humans, the Agency is requesting a

minimum submission of the following mammalian tests: A rangefinding

study that considers the appropriate exposure pathway for the specific

use (e.g. inhalation, oral, etc), and a 90-day subchronic repeated dose

study in an appropriate rodent species (e.g. rats or mice). For some

substitutes, a cardiotoxicity study, usually measuring cardiotoxic

effects in the dog, is also required. Additional mammalian toxicity

tests will be identified by EPA on a case-by-case basis depending on

the particular substitute and application being evaluated. To

characterize aquatic toxicity, both acute and chronic toxicity data for

a variety of species are required. The Agency requires a minimum

aquatic data set to be submitted as described in ``Guidelines for

Deriving Numerical National Water Quality Criteria for the Protection

of Aquatic Organisms and Their Uses,'' which is available through the

National Technical Information Service (#PB 85-227049). All toxicity

data in the submitter's possession and any other available hazard

information, including Material Safety Data Sheets (MSDS), must also be

submitted. Submission of the actual toxicity studies is recommended;

however, it is not necessary to submit these reports if they have been

supplied to the Agency as part of other regulatory submissions. If

studies are not submitted, however, the submitter must provide

sufficiently clear references that the Agency can locate the studies

without delay. As discussed below in section V.C.3., data concerning

the objectives, methodology, results or significance of any toxicity,

metabolism, translocation, or persistence test for a substitute and its

degradation products cannot be held as CBI where such data are also

submitted under TSCA and FIFRA to the extent that confidential

treatment is prohibited under those statutes. Submitters providing

information on new chemicals for joint review under the TSCA and SNAP

programs may be required to supply additional toxicity data under TSCA

section 5.

8. Environmental Fate and Transport

Where available, EPA requests information on the environmental fate

and transport of substitutes. Such data shall include information on

bioaccumulation, biodegradation, adsorption, volatility,

transformation, and other data necessary to characterize a substitute's

movement and reaction in the environment.

9. Flammability

Data on the flammability of a substitute chemical or mixture is

required. Specifically, the flash point and flammability limits are

needed, as well as information on the procedures used for determining

the flammability limits. Testing of blends should identify the

compositions at which the blend itself is flammable, and the changes in

the composition of the blend during various leak scenarios. For

substitutes that will be used in consumer applications, documentation

of testing results conducted by independent laboratories (e.g.,

Underwriters Laboratories) should be submitted, where available. If a

substitute is flammable, the submitter must analyze the risk of fire

resulting from the use of such a substitute and suggest measures to

minimize these risks.

10. Exposure Data

The submitter must provide available modeling or monitoring data on

exposures associated with the manufacture, formulation, transport, and

use of a substitute. Descriptive process information for each

substitute application, as required above, will be used to develop

exposure estimates where exposure data are not readily available.

Depending on the end-use, exposure profiles will be needed for workers,

consumers, and the general population.

11. Environmental Release Data

Data on emissions from the substitute application and equipment, as

well as pollutant releases or discharge to all environmental media

(ambient air, surface and groundwater, hazardous/solid waste) are

needed to complete the risk characterization. Submitters should provide

information on release locations, if known. Available information on

pollution controls that are used or could be used in association with

the substitute (e.g., emissions reduction technologies, wastewater

treatment, treatment of hazardous waste) and the costs of such

technology is also requested.

12. Replacement Ratio for a Chemical Substitute

The Agency requires information on the replacement ratio for a

chemical substitute versus the class I or II substances being replaced.

The term ``replacement ratio'' refers to how much more or less of the

substitute chemical is needed to substitute for the original ozone-

depleting compound being replaced. This ratio will affect the estimated

incremental cost and environmental effects associated with use of the

substitute.

13. Required Changes in Technology

Data on any changes in technology needed to use the alternative are

required. Such information should include a description of whether the

substitute can be used in existing equipment--with or without some

retrofit--or only in new equipment.

14. Cost of Substitute

The Agency requires data on the expected average cost of the

alternative. The cost of the substitute can be expressed, for example,

in terms of $/pound (for a chemical substitute) or as incremental

capital and operating costs associated with a retrofit or new

equipment. In addition, information is needed on the expected equipment

life for an alternative technology. Other critical cost considerations

should be identified, as appropriate. For example, it is important to

understand the incremental costs associated with losses or gains in

energy efficiency associated with use of a substitute relative to

current experience with existing substances.

15. Availability of Substitute

The Agency needs to understand the extent to which a substitute is

already commercially available or the date on which it is expected to

become available. The timing of availability is an important factor in

assessing the overall health and environmental effects of the

substitute.

16. Anticipated Market Share

Data on the anticipated near-term and long-term (over the next ten

years) nationwide substitute sales are also required. This information

can be presented in several ways, for example: a percentage of existing

nationwide use of class I or II chemicals that would be replaced in a

particular end-use; number of units/products to be produced; or pounds

of substitute to be sold. This information is required to assess the

potential effects of a substitute related to total consumption and

environmental releases.

17. Applicable Regulations Under Other Environmental Statutes

The submitter is required to provide information on whether the

substitute is regulated under other statutory authorities, in

particular the Clean Water Act; the Safe Drinking Water Act; the

Resource Conservation and Recovery Act; the Federal Insecticide,

Fungicide, and Rodenticide Act; the Toxic Substances Control Act; the

Comprehensive Environmental Response, Compensation and Liability Act;

the Emergency Planning and Community Right-to-Know Act, and other

titles of the CAA. The Agency will evaluate substitutes under the SNAP

program subject to existing regulatory constraints.

18. Information Already Submitted to the Agency

Individuals may have already submitted information required in the

SNAP Information Notice to the Agency as part of past regulatory and

information-gathering activities. In this case, to minimize reporting

burden, the submitter need not resubmit the data but instead should

provide the following information to help EPA locate the data already

maintained at EPA: Type of information submitted; the date of

submission; the EPA office to which the data were sent; description of

the regulatory program under which the data were submitted; and a

document-control number, if assigned (e.g., a PMN number). If the

submitter cannot provide adequate references for data sent previously

to the Agency as described above, all required information should be

included in the SNAP notice. To facilitate review under SNAP, reports

already submitted to the Agency as part of other regulatory submissions

should be resubmitted if the original information was claimed as

Confidential Business Information when previously submitted.

19. Information Already Available in the Literature

If any of the data needed to complete the SNAP program notice are

available in the literature, the submitter should provide the Agency

with references for such information. Failure to provide the Agency

with an accurate and complete citation may delay review of the notice.

Additionally, submitters are encouraged to provide copies of any

literature to expedite review, particularly if the citation is from a

source not readily available. Any references from sources in foreign

languages should be translated into English prior to submission.

Submissions should be sent to the SNAP Coordinator at the address

referenced at the beginning of this final rule. All submissions must be

provided in three complete copies. If information is claimed as

confidential, all confidential information must be excised from one of

the three copies. This copy will be placed in the public docket. The

other two copies should include the confidential material. If no claims

of confidentiality are made for the submission, all three copies should

be identical. (See below, as well as appendix C, for further guidance

on handling of confidential information under SNAP.)

C. Submission of Confidential Business Information

1. Clean Air Act Provisions

Anyone submitting information for which Confidential Business

Information (CBI) status is requested must assert a claim of

confidentiality at the time of submission. Failure to assert a claim of

confidentiality at the time of submission may result in disclosure of

the information by the Agency without further notice to the submitter.

Further, it should be noted that information which is publicly

available (e.g., in journals, trade magazines, product literature,

etc.) cannot be claimed as CBI. Requesting CBI status for such

information could delay review under section 612. All claims of

confidentiality will be treated in a manner consistent with 40 CFR part

2, subpart B.

The submitter should be advised that under CAA section 114(c),

emissions data may not be claimed as confidential. Moreover, there are

further instances in which confidentiality assertions may later be

reconsidered by the Agency even when confidentiality claims are

originally received. These circumstances are provided in the provisions

of 40 CFR part 2, subpart B. The submitter will be contacted as part of

this evaluation process when such a circumstance occurs.

2. Substantiation of Confidentiality Claims

In the NPRM, EPA proposed to require substantiation of any

confidentiality claims at the time of submission. In making these

claims, the following provisions apply:

--The specific information to which the claim applies must be clearly

marked in the body of the study as subject to a claim of

confidentiality;

--A Supplemental Statement of Data Confidentiality Claims must be

submitted, identifying each section claimed confidential and describing

in detail the basis for the claim. (A list of points to address in such

a statement is included in appendix C);

--The Supplemental Statement of Data Confidentiality Claims must be

signed and dated and must include the typed name and title of the

official who signed it.

EPA also stated that if required substantiation is not provided

when submitting information claimed as confidential, the complete

submitted information may be made available to the public without

further notice to the submitter.

Several commenters indicated that EPA should contact the submitter

before releasing information marked as confidential to the public even

if it does not contain adequate substantiation. One commenter also

indicated that complete substantiation should not be required until the

end of the 90 day review period and that any issue regarding the

adequacy of CBI substantiation should not delay the review process.

EPA agrees with the comment that submitters should be notified

prior to disclosure to the public of information marked as confidential

where substantiation, although it may be inadequate, has been provided.

This will give the submitter opportunity to provide the necessary

additional substantiation or withdraw the submission. However, an

acceptability determination on a substitute will not be published until

all claims of CBI have been fully substantiated under the provisions

described above. Additionally, should no substantiation of CBI claims

be provided, EPA may make the complete submittal available to the

public without further notice to the submitter.

3. Confidentiality Provisions for Toxicity Data

In the event that toxicity or health and safety studies are listed

as confidential, the submitter should be advised that this information

cannot be maintained as confidential where such data are also submitted

under TSCA or FIFRA to the extent that confidential treatment is

prohibited under those statutes. However, any information other than

emissions data contained in the toxicity study that is not health and

safety data and is not relevant to the effects of a substance on human

health and the environment (e.g., discussion of process information,

proprietary blends) can be maintained as confidential subject to the

provisions of 40 CFR part 2, subpart B. The Agency is therefore

requesting that submitters not identify the following information as

confidential when submitting information under TSCA or FIFRA: All

information concerning the objectives, methodology, results, or

significance of any toxicity test or experiment performed on or with a

substitute or its degradation products; any information concerning the

effects of the substitute on any organism (e.g., fish, wildlife, humans

and other mammals) or the environment (e.g., studies related to

persistence, translocation, and fate); and pharmacokinetics/metabolism

studies.

4. Federal Register Requirements

As discussed below in Section VII.A.3.g., the Agency will publish

quarterly notices in the Federal Register updating the list of

acceptable and unacceptable alternatives. If the name of a specific

substitute contained in any studies supporting such notices must be

maintained as confidential, the submitter and the Agency will together

develop a generic name that will protect the proprietary nature of the

substitute, but will provide sufficient detail for the public to

evaluate the health and safety studies. If appropriate, the submitter

may reference any generic names identified for use in the PMN program.

D. Display of OMB Control Numbers

EPA is also amending the table of currently approved information

collection request (ICR) control numbers issued by OMB for various

regulations. This amendment updates the table to accurately display

those information requirements contained in this final rule. This

display of the OMB control number and its subsequent codification in

the Code of Federal Regulations satisfies the requirements of the

Paperwork Reduction Act (44 U.S.C. 3501 et seq.) and OMB's implementing

regulations at 5 CFR part 1320.

The ICR was subject to public notice and comment prior to OMB

approval. As a result, EPA finds that there is ``good cause'' under

section 553(b)(B) of the Administrative Procedures Act (5 U.S.C.

553(b)(B)) to amend this table without prior notice and comment. Due to

the technical nature of the table, further notice and comment would be

unnecessary. For the same reasons, EPA also finds that there is good

cause under 5 U.S.C. 553(d)(3).

VI. Effective Date of Coverage

A. General Provisions

This final rule includes a list of acceptable substitutes and a

list of unacceptable substitutes. Unacceptable substitutes cannot be

used in manufacturing or in final applications as substitutes for

ozone-depleting compounds. The list of unacceptable substitutes and

acceptable substitutes subject to use restrictions becomes binding 30

days after March 18, 1994. In contrast, the list of fully acceptable

substitutes is furnished for the purpose of assisting users in

understanding the full range of available, acceptable substitutes in

each application. Many of the substitutes listed as pending or proposed

in the NPRM have since been added to the final acceptable or

unacceptable lists.

As noted above, the Agency does not believe that determinations on

substitutes that are acceptable with no use restrictions need be made

through rulemaking. Consequently, EPA believes that it is within its

discretion to supplement the list of acceptable substitutes at any time

upon making determinations consistent with the criteria established in

this rulemaking. Until the Agency reaches a final decision restricting

the use of a substitute, vendors are not barred from selling such

substitutes once notification is given and the 90 day prior-to-sale

notification period expires.

B. Grandfathering of Unacceptable Substitutes

EPA is authorized to permit the continuation of activities

otherwise restricted where the balance of equities supports such

grandfathering. Consequently, where appropriate, EPA may grandfather

the production and use of particular substitutes by setting the

effective date of unacceptability listings in the future.

The United States District Court for the District of Columbia

Circuit has established a four-part test to judge the appropriateness

of Agency grandfathering (see Sierra Club v. EPA, 719 F.2d 436 (DC Cir.

1983)). This test involves balancing the results of four analyses,

including whether the new rule represents an abrupt departure from

previously established practice, the extent to which a party relied on

the previous rule, the degree of burden which application of the new

rule would impose on the party, and the statutory interest in applying

the new rule immediately. In each rulemaking listing a substitute as

unacceptable where grandfathering seems appropriate, EPA will conduct

these four analyses and weigh their results. Where the balance of

equities favors grandfathering, EPA will set a delayed effective date

for such listings.

Setting future effective dates to ban the sale and distribution of

specific substitutes will allow the Agency to avoid penalizing those

who in specific applications may have already invested in good faith in

alternatives the SNAP program determines to be unacceptable. For

example, the Agency in this final rule finds unacceptable the use of

HCFC-141b in solvent applications. New information on stratospheric

ozone depletion has increased concern over possible adverse human

health and environmental effects, and the Agency's unacceptable

determination in the case of HCFC-141b reflects these concerns.

However, the Agency recognizes that some solvent users may have

switched to HCFC-141b in good faith, expecting that this substitute

would sufficiently lower the risk of ozone depletion relative to

earlier materials. To provide for these users, the Agency has extended

the effective date for certain end users of HCFC-141b. See the listing

determination narrative discussion in section IX.F., as well as the

listing tables in appendix B, for a full discussion of HCFC-141b and

associated effective dates. Finally, to balance the desire not to

penalize those who switched early in good faith with the need to avoid

creating an incentive for continued investment in alternatives the

Agency wishes to discourage, the longer-term effective dates discussed

above will affect only existing uses.

VII. Notice, Review, and Decision-making Procedures

The purpose of this section is to summarize the procedures for

submitting the required information to the Agency, the steps EPA will

take in reviewing SNAP submissions, and the process of making

determinations based on these reviews. This section focuses on three

procedures, summarized in Exhibit 1, depending on the nature of the

submission received by the Agency. Some substitutes may already be

approved or may not need approval under other environmental statutes,

especially TSCA and FIFRA. These substitutes, in consequence, would

only require review under the SNAP program. Section VII.A. discusses in

greater detail the submission and review process for alternatives that

fall into this category. In other cases, a substitute will require

review under section 612 as well as relevant provisions of TSCA and

FIFRA. With respect to any substitute that is a new chemical (i.e., not

currently listed on the TSCA inventory), information must be submitted

to the Agency for review both under the SNAP program and the PMN

program. Section VII.B. describes steps for this review in more detail.

For alternatives to class I and II chemicals that will be used in

pesticide products, the substitute manufacturer will need to file

notification jointly with EPA's Office of Pesticide Programs (OPP) and

EPA's SNAP program. Section VII.C. discusses the latter procedure. The

SNAP program has coordinated closely with each of these regulatory

programs to establish a joint review process that will ensure

consistency in the final decisions, while minimizing the time for

review, the reporting burden, and the costs for both the submitter and

the Agency.

Billing Code 6560-50-P

TR18MR94.000

TR18MR94.001

BILLING CODE 6560-50-C

A. Substitutes Reviewed under SNAP Only

1. Applicability

Sections IV. and V. describe the conditions dictating review under

the SNAP program only and the general reporting requirements under

section 612. If any of these conditions are met and the substitutes are

not exempt as described in section IV.B.3., Exemptions from Reporting,

a SNAP notice must be submitted.

2. Pre-Notice Communication

Prior to submitting the SNAP notice, each submitter is encouraged

to contact EPA's SNAP Coordinator to discuss the notification process.

Among other things, the SNAP Coordinator will: (1) Assist the potential

submitter in determining whether a SNAP notice is needed; (2) answer

questions regarding how to complete a submission; (3) provide all

necessary forms and the guidance manual; (4) serve as the initial point

of contact when the notice is submitted; and (5) oversee the assignment

of a SNAP program tracking number to the notice once it is received by

the Agency. A copy of the SNAP Information Notice and Guidance Manual

may be obtained from the SNAP Coordinator at the address listed at the

beginning of this final rule. Specific data requested are described in

section V.

3. Processing of Completed SNAP Submission

a. 90-Day review process. As required under section 612(e), a

manufacturer of a substitute for a class I chemical must provide the

Agency with notification at least 90 days prior to introducing into

interstate commerce any new or existing chemicals for significant new

uses as class I alternatives. The same requirements apply to

manufacturers of substitutes for class II substances, although in this

case the Agency is drawing on general authorities contained in sections

114 and 301 of the CAA in order to fulfill the purpose of section

612(c). EPA intends to review these substitutes within a 90-day period

to ensure prompt response for manufacturers initiating production of

substitutes. EPA's 90-day review period for SNAP submissions begins

once EPA receives a submission, as described in section V.B. above. If

a submission does not include adequate data, EPA may return the

submission to request specific additional information. Section 114 and,

in the case of petitions, section 612(d) authorizes EPA to require

manufacturers to support their SNAP submissions with data adequate to

facilitate EPA's review.

b. Initial receipt of the SNAP submission. (1) Initial review of

submission. EPA will conclude a completeness review of each submission

within fifteen days of receipt of the submission. Within the 15-day

period, EPA will inform the submitter of any additional information

needed. If EPA makes no such request, then after the 15-day period is

concluded, the 90-day review period will automatically commence. If EPA

does request any additional data, the 90-day period shall not commence

until the additional data are received and themselves reviewed for

completeness.

During the 15-day completeness review, the SNAP Coordinator will

first review the SNAP Information Notice to ensure that basic

information necessary to process the submission is present (i.e., name

of company, identification of substitute, etc.). A more detailed review

of supporting technical data will then ensue, as well as an examination

of substantiation provided for any claim for confidentiality of

information. Should additional information be required, EPA will

contact the submitter within 15 days of receipt of the original

submission.

During the 90-day review period, EPA may ask for additional

information from submitters as necessary, although manufacturers of a

new substitute may introduce the substitute into interstate commerce 90

days after EPA receives a submission for the product if the Agency has

not already rendered an unacceptability determination. In the case of a

substitute which already exists in the marketplace prior to the

issuance of this final rule, manufacturers must submit a completed SNAP

Information Notice as soon as possible, and not later than 90 days

after the effective date of this rule. During EPA's review, use of an

existing substitute may continue, and need not cease unless and until

EPA adds the substitute to the list of unacceptable substitutes as a

result of notice-and-comment rulemaking.

(2) Letter of receipt. The SNAP Coordinator will send a letter of

confirmation to the submitter once the Agency has received the SNAP

Information Notice and reviewed it for completeness. This letter will

include the date of advance notification to the Agency, the starting

date of EPA's 90-day review period, and the SNAP program tracking

number assigned to the submission.

c. Determination of data adequacy. As part of the review for a SNAP

submission, the Agency will complete a preliminary determination of the

adequacy of data supporting the application. The Agency will issue this

determination within 15 days after receipt of the application. At any

time during the review period, if information is not adequate to allow

the Agency to reach a SNAP determination, EPA will contact the

submitter and request the missing data. EPA believes it appropriate and

authorized under section 114 to require the submitter to provide all

data needed to complete the review of the SNAP notice. Depending on the

type of information needed and the time necessary to compile and submit

the requested data to the Agency, EPA may suspend or extend the review

period. This will not affect the ability of a manufacturer to begin

marketing a new substitute 90 days after advance notification to the

Agency, or in the case of a pre-existing substitute, to continue

marketing.

In a few cases, the Agency and the submitter may disagree on a

schedule for furnishing additional data EPA deems necessary to

determine the acceptability of the substitute. If in these cases EPA

has reason to believe that such a substitute may be unacceptable, the

Agency may exercise the option of proposing to list the substitute as

unacceptable based on existing data until the necessary data are

provided, due to the uncertainty of the risks associated with use of

the substitute.

d. Availability of new information during review period. If

critical new information becomes available during the review period

that may influence the Agency's evaluation of a substitute, the

submitter must notify the Agency about the existence of such

information within ten days of receiving such data. The submitter must

also inform the Agency of new studies under way, even if the results

will not be available within the 90-day review period. The Agency may

extend or suspend the review period depending on the type of

information at issue and the stage of review. Again, this will not

affect a manufacturer's ability to market a substitute 90 days after

initial notification to the Agency.

e. Completion of detailed review. Once the submission is found to

be supported by adequate data, the Agency will commence a detailed

evaluation of the notice. As this review proceeds, EPA may contact the

submitter for additional scientific and technical information to assist

in the evaluation. This will ensure that the review is completed

quickly and that it reflects the best available information. Final

decisions will be based on detailed analysis completed during this

stage of review.

f. Vendor lists. As part of EPA's outreach and clearinghouse under

SNAP, the Agency will use the SNAP determinations to compile a list of

vendors for the convenience of potential users. Companies could then

ask EPA to review their specific substitute, to ensure that it is

covered by the listing decisions on acceptable substitutes, and to add

the company to the vendor list. The Agency believes that specific

information on vendors of acceptable substitutes would be useful to

companies switching out of class I and II compounds.

g. Communication of SNAP determination. (1) SNAP determinations on

90-Day notifications. EPA's determinations on SNAP submissions that

come as a result of the 90-day advance notification requirement will

take the form of either adding substances to the list of acceptable

substitutes or by proposing to add them to one of the following lists:

acceptable subject to use conditions, acceptable subject to narrowed

use limits, or unacceptable substitutes.

(2) Communication of SNAP determination to the submitter. Once

Agency review has been completed, the submitter will be notified in

writing of the determination under SNAP. At this time, the submitter

will also be informed if any restrictions are attached to the

acceptability of a substitute. Following the expiration of 90 days

after submitting advance notification to EPA, companies may begin sale

or manufacture of a new substitute. They may continue to sell or

manufacture an existing substitute through the review period, unless

and until the Agency places such substitute on the list of unacceptable

substitutes as a result of rulemaking. Sale or manufacture may begin

and continue even if the Agency fails to reach a decision or notify the

submitter of that decision within 90 days of advance notification of

EPA.

(3) Communication of SNAP determination to the public. (a) Federal

Register notice. To provide the public with updated information on SNAP

determinations, the Agency will publish in the Federal Register a

complete list of the acceptable and unacceptable alternatives reviewed

to date. This list will be published four times each year and will

include recent decisions made under the SNAP program. In addition to

the quarterly publications, the Agency will communicate decisions

through a clearinghouse and outreach program, as discussed in the next

section, as well as through the Stratospheric Ozone Protection hotline.

(b) Outreach and clearinghouse. Section 612(b)(4) requires the

Agency to maintain a public clearinghouse of alternative chemicals,

product substitutes, and alternative manufacturing processes that are

available as replacements for class I and II chemicals. The

clearinghouse will distribute information on substitutes that are

acceptable under the SNAP program. For the convenience of companies

wishing to identify substitutes, the Agency will maintain a list of

vendors selling substitutes as discussed in section VII.A.3.f.

In addition, the Agency will enter data on substitutes into the

Pollution Prevention Information Exchange System (PPIES) database,

which is maintained by EPA's Office of Research and Development. This

database contains information on numerous pollution prevention options

for a wide variety of industrial sectors and chemicals. PPIES can also

be accessed from a variety of other pollution prevention databases

maintained by other federal agencies and industry.

4. Decision-Making Framework

a. Decisions by substitute and use. As required by section 612(c),

the Agency must publish a list of substitutes unacceptable under the

SNAP program and a list of acceptable alternatives for specific uses.

Given that environmental exposure and risk profiles can change

significantly from one end-use to the next, it is essential to evaluate

and list substitutes in the context of their intended use. The Agency

identified a number of end-uses in each sector by which to list

substitutes, and section IX provides risk management decisions for many

existing substitutes in each of the principal sectors.

The Agency will be as specific as possible in listing substitutes

by providing exact chemical names of substitutes. For most substitutes,

a broad chemical classification (e.g., aromatic hydrocarbons, or HCFCs)

is not specific enough because of differences among chemicals belonging

to each of these groups. Thus, where appropriate, EPA will provide a

more specific description of the substitute by application.

The Agency anticipates two possible exceptions to this practice.

The first is where release of the chemical identity of a substitute

constitutes release of proprietary information. In that event, the

Agency will report generic chemical names based on chemical classes as

described in section V.C. The other exception would be in cases where

the Agency believes that a more general categorization is needed to

account for the diversity of possible chemicals used in a particular

set of substitutes. For example, in the solvents cleaning sector, many

substitutes are formulations composed of compounds drawn from several

categories of chemicals. In this case, the toxicity profile of each

chemical is similar to those of other chemicals in that class.

b. Decision categories. Under section 612, the Agency has

considerable discretion in the risk management decisions it can make in

SNAP. In this final rule, the Agency has identified five possible

decision categories, as described below. Commenters suggested that

there was confusion with the Agency's intent to designate some

substitutes as acceptable subject to narrowed use limits versus

unacceptable except for critical use exemptions. In response to these

comments, the Agency has determined that the goal of both categories

was to limit the use of a substitute that had generally unacceptable

characteristics yet provide relief for specialized applications within

an end-use where no other alternatives exist. Given the similarity in

goals, the decision categories have been streamlined by eliminating the

category listed in the NPRM as ``unacceptable except for critical use

exemptions.'' Those substitutes that were listed in the NPRM as

proposed unacceptable except for critical use exemptions are listed as

unacceptable in this final rule, and the concerns which the critical

use exemption petition process was created to address will now be

addressed as part of EPA's responsibilities under the section 612(d)

petition process.

(1) Acceptable. Where the Agency has reviewed a substitute and

found no reason to prohibit its use, it will list the alternative as

acceptable in the end-uses for which the submitter provided

information. Where appropriate, the Agency may provide some additional

comment (e.g., general recommendations encouraging recapture and

recycling). However, these comments are not conditions for use of the

substitute.

(2) Acceptable subject to use conditions. As proposed in the NPRM,

after reviewing a submission, the Agency may determine that a

substitute is acceptable if certain conditions on use are adopted. The

Agency cannot predict at this time all necessary restrictions, but has

imposed some conditions based on substitute reviews already completed

for this final rule. Several commenters supported the application of

use conditions as necessary in providing important guidance to

companies in reviewing alternative replacements for ODSs. While also

supporting use conditions generally, other commenters noted that they

should be used sparingly, so as to create the minimum uncertainty in

the regulated community and encourage swift transition.

The Agency agrees with these comments. In this final rule, any

conditions imposed will depend on the risks involved and the substitute

and application in question. For example, the Agency may impose

conditions on the use of a substitute and require recycling equipment

to limit workplace and ambient releases or require use of other control

practices within a certain application. Where a substitute is found

acceptable subject to conditions on uses, use without adherence to the

conditions in the relevant end-use is prohibited in this final rule.

Determinations of acceptability subject to use conditions will only be

made pursuant to notice-and-comment rulemaking.

In implementing conditions on use, the Agency has sought to avoid

overlap with existing regulatory authorities. EPA has taken a number of

steps to mitigate this potential for duplication. First, EPA intends to

restrict the use of conditions to cases in which clear regulatory gaps

exist. Second, these existing regulatory gaps must render the use of a

substitute an unreasonable risk in the absence of any additional

controls. Third, in the limited cases in which conditions may be

necessary, the Agency will impose them only as a result of formal

notice-and-comment rulemaking. Finally, use conditions will be

effective only until other appropriate regulatory controls are imposed

under other authorities and will be withdrawn by the Agency when they

are superseded by such controls.

(3) Acceptable subject to narrowed use limits. The Agency cannot

restrict use of a substitute under SNAP if there are no technically

feasible alternatives to the use of an ozone-depleting compound. Thus,

EPA may approve a compound not for general use within a sector, but for

use only within certain specialized applications within a sector end-

use. EPA refers to these restrictions as narrowed use limits. For

example, the Agency could list a substitute with a generally

unfavorable environmental or human health effect as acceptable in

certain specific metals cleaning applications in the solvents cleaning

sector. This would allow transition away from the damaging ozone-

depleting compounds to proceed, by allowing industry the flexibility to

use in narrow niche applications a substitute which provides the only

means of transition. At the same time, the narrowed use determination

prevents a widespread shift of an entire sector to substitutes which

overall do not offer the risk reduction available through the use of

other alternatives.

Clearly, any limits imposed will depend on the risks involved and

the substitute and application in question. To provide adequate

opportunity for comment by the regulated community, EPA will complete

notice-and-comment rulemaking before promulgating any finding that a

substitute is acceptable only subject to a narrowed use limit.

In implementing narrowed use limitations, the Agency has sought to

allow agents for specific uses that would otherwise be deemed

unacceptable. This policy serves the larger goal of facilitating the

fastest possible transition from ozone-depleting compounds by expanding

the list of alternatives available to all applications within a sector

end-use category. EPA recognizes that certain sector end-uses encompass

a broad range of applications, manufacturing processes and products.

Under the acceptable for narrow use category, EPA will accept a

substitute for use only in certain specialized uses within the broader

end-use. The intent of the narrowed use limitation is to restrict the

use of a substitute that the Agency deems unacceptable for the full

range of applications or products within a sector end-use category.

Where a substitute is found acceptable subject to narrowed use limits,

general use within the relevant end-use is prohibited.

Before users adopt a restricted agent within the narrowed use

limits category, they must make a reasonable effort to ascertain that

other substitutes or alternatives are not technically feasible. Users

are expected to undertake a thorough technical investigation of

alternatives before implementing the otherwise restricted substitute.

The Agency expects users to contact vendors of alternatives to explore

with experts whether or not other acceptable substitutes are

technically feasible for the process, product or system in question. To

further assist users in their evaluation, EPA has prepared a list of

vendors manufacturing other substitutes. Although users are not

required to report the results of their investigation to EPA, companies

must document these results, and retain them in company files for the

purpose of demonstrating compliance. Both the Vendor List and the

Guidance Manual are available from the SNAP program, or through EPA's

Stratospheric Ozone Protection Hotline.

In October 1993, the President directed EPA through the Climate

Change Action Plan (CCAP) to use its authority under section 612 of the

Clean Air Act to narrow the uses of CFC substitutes with high global

warming potential. Because EPA is simultaneously also interested in

promoting the broader shift away from ozone-depleting compounds, EPA

will make every effort to assure that these limits on use will be

imposed in ways that preserve as much flexibility as possible for those

trying to move to alternatives.

In this final rule, EPA has imposed narrowed use limitations on the

acceptability of perfluorocarbon (PFC) substitutes when used in solvent

cleaning, and fire suppression. EPA has imposed these limitations

because of the high global warming potential and long atmospheric

lifetimes of the PFC compounds as compared with other alternatives

available for the same end-uses. Comparable limitations on the use of

refrigerants and aerosols containing PFCs are also likely to be

proposed shortly. In the case of fire suppression and explosion

protection, EPA has taken the approach of narrowing uses to prevent or

delay emissions of global warming gases. This is preferable to the

outright prohibitions EPA would otherwise be authorized to impose where

other alternatives are available, because in these limited cases users

may have no other feasible alternatives to continued reliance on ozone-

depleters.

Through the notice and comment rulemaking process, other companies

or vendors will be able to scrutinize the proposed narrowed use limits.

This may bring to light new alternatives or processes of which the user

and EPA are unaware, and these new alternatives may pose lower overall

risks than the substances which have been the subject of the narrowed

use designation. If an acceptable listing is revoked based on the

availability of a new, lower-risk alternative, companies that have made

investments in technology which was earlier deemed as having no

alternatives available may be granted permission to extend their use

for a limited period of time, consistent with EPA's grandfathering

approach described above in section VI.B.

The Agency has prepared guidance describing additional

documentation users should include for narrowed use applications. This

information includes descriptions of:

Process or product in which the substitute is needed;

Substitutes examined and rejected;

Reason for rejection of other alternatives, e.g.,

performance, technical or safety standards; and/or

Anticipated date other substitutes will be available and

projected time for switching.

In addition to this basic information, the guidance includes

specific data for end-uses in each sector. The guidance is available

from the SNAP program.

(4) Unacceptable. The Agency has the authority under section 612(c)

to prohibit the use of a substitute believed to present adverse effects

to human health and the environment where alternatives that reduce

overall risk are available. The Agency will only use this provision

where it has identified other substitutes that are currently or

potentially available and that pose lower overall risks. Substitutes

will be listed as unacceptable through the rulemaking process.

(5) Pending. The Agency will describe submissions for which the 90-

day review period is underway and for which EPA has not yet reached a

final decision as pending. For all substitutes in the pending category,

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 the authority under section 114 to

gather this information, if necessary. Again, a delay of the review

period will not affect a manufacturer's ability to sell a product 90

days after notification of the Agency as described above.

c. Implications of other regulatory requirements. In evaluating

substitutes, the SNAP program takes into consideration the regulatory

requirements of other environmental and health protection statutes

(e.g., the Clean Water Act or the Occupational Safety and Health Act).

In considering the framework of existing regulatory constraints, the

Agency's evaluation of alternatives will assume compliance with their

provisions.

However, it will not be possible to factor in regulatory

requirements that are still under development (e.g., more stringent

requirements to control volatile organic compounds and hazardous air

pollutants under title I and title III of the CAA). In these instances,

a substitute may be deemed acceptable under SNAP, but is not thereby

excused from compliance with any future regulations. The Agency does

not believe that it was the intent of Congress to use the authority

under section 612 to compromise other regulatory requirements. Should

future regulations severely limit the availability of the only

acceptable substitute for a specific end-use, EPA would reconsider the

advisability of keeping any other alternatives which could be used in

that application on the list of unacceptable substitutes.

5. EPA-Generated Review of Substitutes

In addition to SNAP notifications received under section 612 for

substitute review, the Agency is authorized by section 612(c) to add or

delete alternatives to the list of reviewed substitutes on its own

initiative. EPA has many efforts under way to identify and communicate

the availability of promising new alternatives. These include support

for research efforts to study and focus attention on future

substitutes, involvement in the United Nations Environment Programme's

biannual assessment of technologies for key sectors currently using

ozone-depleting chemicals, and technology transfer projects with

industry, other federal agencies, and developing nations. Based on

information available through these activities, EPA may initiate review

of new substitutes under section 612. In each case, the next planned

quarterly Federal Register notice updating the status of SNAP

determinations will inform the public that EPA is initiating a review,

subject to the provisions discussed in this final rule. Similarly,

determinations ultimately reached as a result of these internally-

generated reviews will be included in these quarterly updates.

B. Joint Review of New Substitutes under SNAP and TSCA PMN

1. Applicability

Any potential SNAP submitter who intends to introduce a new

chemical (i.e., a chemical not currently included in the TSCA

inventory) as an alternative for a class I or class II chemical must

undergo review not only under section 612, but under section 5 of TSCA

(the Premanufacture Notice program) as well. Because of the overlap in

statutory authority, the Agency has established a joint review process

between the SNAP and TSCA Premanufacture Notice (PMN) programs. This

process has been structured to minimize reporting burden and to ensure

consistency in decisions between the two programs. The following

sections describe the joint review and decision-making process in more

detail.

2. Data Submission Requirements and Process

a. SNAP and PMN forms. The Agency has reviewed the data submission

needs for the SNAP and PMN programs and found significant overlap. In

general, the Agency has identified only a few additional data elements

beyond those already required by the PMN program that should be

included for review under the SNAP program. These elements are:

Ozone depletion potential.

Global warming potential.

Cost of using the substitute, including:

--Chemical replacement data.

--Chemical cost data.

--Incremental equipment expenditures (either new or retrofit) needed to

use substitute.

--Information on the cost implications of changes in energy consumption

(e.g., from the use of a less or more energy-efficient refrigerant).

Documentation of testing results regarding the

flammability of substitutes, especially when proposed for consumer

applications.

Given this overlap, a submitter requesting a review under both the

SNAP and PMN programs should provide the above information by following

these steps:

Complete the PMN form (EPA Form 7710-25) following the

Instructions Manual currently available through the TSCA Assistance

Information Service.

Indicate on page 11 of the PMN form, ``Optional Pollution

Prevention Information,'' that the chemical to be reviewed is also to

be considered under the SNAP program.

Complete a SNAP addendum that requests information only on

those items listed above. (The addendum can be obtained from the SNAP

program, or EPA's Stratospheric Ozone Protection Hotline.)

The completed PMN form (EPA Form 7710-25) will remain the basis for

all information needed to complete review of the new chemical under

section 5 of TSCA. The completed PMN form and the SNAP addendum

together will comprise the data submission for section 612 review and

listing decisions for new chemicals. This approach is intended to

minimize the reporting burden on submitters.

The Agency will modify the PMN Instructions Manual to provide more

explicit direction on how to complete the SNAP addendum. A SNAP

submitter may also consult the SNAP Guidance Manual, which is available

from the Stratospheric Ozone Protection Hotline. Any questions

regarding the completion of these forms can be directed to either the

PMN Pre-notice Coordinator or the SNAP program.

b. Submission of completed forms. Both the PMN and SNAP programs

have a review period of 90 days, subject to suspensions and extensions

described in section VII.A. for the SNAP program and in the PMN final

rule (40 CFR 720.75). To ensure that new chemical submissions are

reviewed and decided on jointly, the Agency encourages submitters to

provide both the PMN form and SNAP addendum to the PMN and SNAP

coordinators. Failure to provide both programs with the requested

information at the same time could result in delays in the review of a

submitter's notice seeking acceptance of a new chemical as a class I or

II substitute concurrent with review under the PMN program.

c. Procedures for handling confidential business information. The

Agency recognizes that, where appropriate, information submitted to the

PMN and SNAP programs may need to be held confidential. EPA has

determined that all CBI submitted as part of the joint PMN/SNAP review

should be maintained and treated in a manner consistent with TSCA

security procedures. Confidentiality claims will be processed and

reviewed in a manner consistent with 40 CFR part 2, subpart B. This

approach was selected because the majority of data provided to SNAP

under the joint review process will come from the PMN form. Submitters

should note that while TSCA and CAA may have different language

describing CBI handling procedures, there is no substantive difference

in how CBI is maintained under the two statutes.

3. Agency Review of New Substitutes under PMN and SNAP

a. Preparation of public docket and Federal Register notices. Once

the letter of receipt has been issued, the PMN program will prepare a

public docket and Federal Register notice, as described in the final

rule for the PMN program (40 CFR 720.75). The PMN program manager will

consult with the SNAP program in preparing the notice.

b. Joint review process. EPA will complete joint evaluations of new

chemicals serving as class I or II substitutes under section 5 of TSCA

and section 612 of the CAA. This joint review process will be

coordinated to ensure that there is consistency in the final decisions

made under the PMN and SNAP programs. To ensure agreement in the

decisions, EPA offices will work in concert to develop toxicity,

exposure, and risk profiles for those substitutes and applications that

come under joint TSCA and CAA review authority. The Agency will also

coordinate its review of the completeness of the information supplied

and any subsequent data requests to minimize the reporting burden on

the submitter. Submitters should note that Agency decisions to restrict

production of particular chemicals under TSCA will, in the case of

joint PMN/SNAP applications, also have the effect of restricting

production of substitutes undergoing review under the SNAP program.

However, companies that produce substitutes only being reviewed under

the SNAP program are not required to cease production during the SNAP

review period in the case of existing substitutes, and in the case of

new substitutes, manufacturers may introduce the substitute into

interstate commerce 90 days after submitting their complete

notification to EPA.

As part of the review, the PMN and SNAP programs will work to

arrive at a consistent decision regarding the new chemical under

review. Consequently, listing decisions under SNAP will reference any

conditions also incorporated into the PMN review (e.g., submission of

additional toxicity information, restrictions on use, etc.).

If a substitute meets the conditions for general PMN approval but

not for SNAP acceptability, the company may produce and market the

substance in question once the 90-day period has elapsed. However, EPA

will commence a rulemaking to prohibit the use of the substitute as a

class I or II substitute. If the chemical fails to meet the conditions

for PMN approval, the submitter is barred from producing the chemical

and consequently is effectively barred from marketing the product as a

substitute for a class I or II compound. Submitters should note,

however, that CAA section 612 places considerable emphasis on

identifying and promoting the use of substitutes which, relative to

others, reduce overall risks to human health and the environment. To

the extent a substitute offers such risk reduction, EPA will make every

effort to facilitate production and use of that alternative.

c. Communication of decision. The PMN program will use the existing

TSCA regulatory framework for communicating decisions on the new

substitute to the submitter. The SNAP program will provide public

notice of decisions regarding the acceptability or unacceptability of a

substitute following the process described in section VII.A.3.g. EPA

will contact the submitter to determine how best to list the substitute

under the SNAP program if necessary to protect the confidentiality of

the alternative.

C. Joint Review of Substitutes under SNAP and FIFRA

1. Background on Use of Ozone-Depleting Chemicals in Pesticides

Certain pesticides are formulated with class I and II chemicals.

Examples include the use of methyl chloroform (1,1,1-trichloroethane)

as an inert ingredient, or the use of methyl bromide as an active

agent. Pesticide products that contain class I and II compounds must be

reformulated as these chemicals are phased out of production pursuant

to Clean Air Act section 604. This section describes how the Agency

will handle reviews of these changes.

2. Applicability

Any new pesticide or amendment of an existing formulation is

already subject to Agency approval under current provisions of the

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Public Law

100-460, 100-464 to 100-526, and 100-532. However, as of the effective

date of the SNAP program, new pesticides or formulation changes based

on class I or class II substitutes will also be subject to review under

section 612 of the CAA. These authorities apply in all cases where a

manufacturer amends a pesticide product to replace chemicals being

phased out under CAA section 602 or 604. Similarly, registrations of

new pesticide products will also be subject to SNAP review if the new

formula contains chemicals functionally replacing class I or class II

compounds which would otherwise have been used in the new pesticide

formulation.

3. Review Responsibilities Under FIFRA and CAA/SNAP

In general, review responsibilities for pesticide products under

the CAA SNAP program will focus on a substance's ozone depletion and

global warming potential. The FIFRA reviews will address factors

commonly examined during pesticide amendments and registrations. The

two program offices responsible for these reviews will coordinate their

efforts at critical junctures and share pertinent data to ensure

appropriate technical consideration of the substitute.

4. Data Submission Requirements and Process

a. Preparation of applications. The Agency has reviewed the data

submission needs for the SNAP and FIFRA pesticide amendment/

registration process and found no significant overlap. Because there is

so little overlap, the Agency requires that a submitter requesting

review under both SNAP and the Office of Pesticide Programs' (OPP)

pesticide amendment/registration process submit all information

ordinarily required for the OPP process as well as a fully completed

SNAP information form. A copy of the FIFRA form should be submitted to

OPP, and a copy of the SNAP form should be submitted to the SNAP

Coordinator. The SNAP form can be obtained from the SNAP program. For

further guidance, SNAP submitters may also consult the SNAP Guidance

Manual, which is available from the Stratospheric Ozone Protection

Hotline.

If a registrant is submitting an amendment to a product

registration under FIFRA that currently contains a class I or II

substance, he or she should note in section II (``Amendment

Information'') of the FIFRA form that the amendment was filed in

response to the CAA production phase-out. Similarly, if a registrant is

submitting an application for a new pesticide registration that would

otherwise have been based on a class I or II compound, he or she should

note in Section II of the FIFRA form that the registration includes a

class I or II substitute.

The submitter should also identify in Section II both the

substitute chemical and the class I or II compound it is replacing.

Further, if a registrant is aware that a particular chemical intended

for use as a class I or II substitute in a pesticide formulation has

already been accepted through earlier SNAP/FIFRA determinations, the

registrant should also reference the relevant part of the prior review.

b. Review of applications. When the Agency receives the FIFRA

application and SNAP submission, it will log each into the relevant

tracking systems: the OPP's tracking system for the FIFRA application

and the SNAP tracking system for SNAP submissions. If the FIFRA

application is identified in section II as a Clean Air Act

substitution, the FIFRA program coordinator will contact EPA's SNAP

program to ask if the substitute has been the subject of any prior SNAP

reviews. If the registrant's substitute is already on the list of

unacceptable substitutes, EPA will notify the registrant that the

amendment request cannot be granted. If the registrant's substitute is

already on the list of acceptable substitutes, EPA will proceed with

the standard FIFRA application review. If a chemical substitute is not

listed under existing SNAP determinations but is a substitute for an

ozone-depleting compound, EPA will inform the registrant that a SNAP

review must commence.

5. Communication of Decision

Once EPA review is complete, the Agency will notify the registrant

whether the new formulation or proposed formulation change is

acceptable. At the same time, the Agency will amend the SNAP

determinations to reflect these findings and will publish the revised

determinations in the next quarterly Federal Register notice.

Submitters should note that, because of the shared authority to review

substitutes under both SNAP and FIFRA, formulators may not sell amended

or new formulations subject to FIFRA until they have received FIFRA

approval.

D. Shared Statutory Authority with the Food and Drug Administration

The Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. 321,

provides for the safety and effectiveness of drugs and therapeutic

devices, the purity and wholesomeness of foods, and the harmlessness of

cosmetics. Under this statute, the Food and Drug Administration (FDA)

regulates the packaging of food products and incidental additives and

requires predistribution clearance of medical devices.

As defined in the FDCA, medical devices can include any devices,

diagnostic products, drugs, and drug delivery systems. Devices covered

under this jurisdiction are subject to review under the FDCA. Some

medical devices and food packaging currently contain class I or II

compounds. The Agency has determined that such products are exempt from

further review for human health effects under the SNAP program where

FDA approval of such effects is required before a product can be

introduced into commerce. EPA will rely in its SNAP determination on

FDA's conclusions regarding health effects. The Agency believes this

exemption is justified because of the higher burden of proof placed on

submitters under the FDCA. However, the Agency will continue to

evaluate all other environmental effects of the proposed substitute,

and will consult with the FDA to determine the appropriate course of

action.

VIII. Petitions

A. Background

1. Role of Petitions

Section 612(d) of the CAA explicitly states that ``any person may

petition the Administrator to add a substance * * * or to remove a

substance from either of such (prohibited or safe use) lists.'' The

petition provision serves two principal needs. The first is to permit

the appeal of existing Agency determinations under the SNAP program.

The second is to provide a mechanism for individuals and organizations

to bring to the Agency's attention new information on substitutes that

could affect existing listing determinations or result in new ones.

The opportunity for outside parties to comment on existing listing

decisions is an important aspect of the petition process. As discussed

in the section on notifications, companies that produce substitutes

must submit specific data on the substitutes to the Agency for review.

However, organizations and private citizens other than those required

to submit SNAP notices may have additional information about existing

substitutes or information on new substitutes not yet reviewed by the

Agency. To ensure that the SNAP determinations are based on the best

information on substitutes, it is essential that the Agency offer a

means for such information to be incorporated into the SNAP analyses on

a continuing basis.

Before individuals, organizations, or companies may initiate legal

action against EPA for the purpose of changing the lists of acceptable

or unacceptable substitutes, they must first exhaust all administrative

remedies for receiving such relief, including remedies like the

petition process described in this section.

2. Types of Petitions

Five types of petitions exist:

(1) Petitions to add a substitute not previously reviewed under the

SNAP program to the acceptable list;

(2) Petitions to add a substitute not previously reviewed under the

SNAP program to the unacceptable list;

(3) Petitions to delete a substitute from the acceptable list and

add it to the unacceptable list or to delete a substitute from the

unacceptable list and add it to the acceptable list;

(4) Petitions to add or delete use restrictions on an acceptability

listing, and

(5) Petitions to grandfather general use of an unacceptable or

acceptable subject to narrowed use limits in specified applications

substitute.

Petitioners should note that the first type of petition is

comparable to completing a SNAP submission, except that the latter is

submitted by substitute producers prior to the introduction into

interstate commerce of the substitute for a significant new use as a

class I or II substitute. The first type of petition, by contrast,

would generally be initiated by entities other than the company

responsible for producing the substitute. Companies that manufacture,

formulate, or use a substitute themselves and want to have their

substitutes added to the acceptable list should submit information on

the substitute under the 90-day advance notification review program.

3. Basis for Petition

A petitioner may submit a petition for several reasons, including:

Availability of new information on substitutes or

applications not covered in the existing SNAP determinations;

Requests to extend effective date for existing

prohibitions on uses of an unacceptable substitute;

New technologies or practices that reduce exposures to a

substitute previously unacceptable under SNAP due to toxicity concerns;

or

Requests for acceptability subject to narrowed use limits

listing for specialized applications within a sector end-use for an

unacceptable substitute where no other technologically viable

substitute can be found.

All of the above are examples of valid justifications for

submitting a petition. Other bases for petitioning the Agency may exist

as well, and all petitions with adequate supporting data will receive

consideration under the SNAP program.

4. Nature of Response

The Agency will only review and grant or deny petitions based on

the sector and end-use application identified in the petition. For

example, simply because the Agency ultimately deletes a substitute from

the list of acceptable substitutes for a particular end-use in the

solvents cleaning sector does not mean the substitute is unacceptable

for any specific end-use as a refrigerant. A similar caveat applies for

petitions on applications within a sector. If a substitute, for

instance, is found acceptable for a specific end-use within an

application, it will not automatically be deemed acceptable for any

other end-use in that sector.

B. Content of the Petition

The Agency requires the following information: A brief statement

describing the type of petition, substitute, sector and end-uses to

which it applies; and a brief summary of the basis for the petition and

the data that support the petition. As with SNAP submissions, the

Agency will issue a determination letter on the completeness of the

petition to the petitioner within 15 calendar days of its receipt.

Petition types (1) and (2) must contain the information described

in section V.B. of this notice, which lists the items to be submitted

in a 90-day notification. Information requirements for such petitions

and 90-day notifications are the same, since the Agency will be

applying the same level of analysis to petitions submitted by outside

parties as to notifications received from the producing companies

themselves. For petition types (3) and (4), which request a

reexamination of a substitute previously reviewed under the SNAP

program, the submitter may reference the prior submission rather than

submit duplicate information. In this case, the petitioner should

provide and submit as appropriate any new or additional data. Petitions

to grandfather use of an unacceptable substitute must describe the

applicability of the four-part test to judge the appropriateness of

Agency grandfathering as described in section VI.B. of this final rule.

C. Sufficiency of Data

Petitioners should be aware that insufficient data may prevent the

Agency from reaching a timely decision on whether to grant or deny a

petition. EPA will conclude a completeness review of each petition

received within fifteen days of receipt of the petition. Within the 15-

day period, EPA will inform the petitioner of any additional

information needed. If EPA makes no such request, then after the 15-day

period is completed, the 90-day review period will automatically

commence. If EPA does request any additional data, the 90-day period

shall not commence until the additional data are received and

themselves reviewed for completeness.

As provided in section 612(d), any petition must ``include a

showing by the petitioner that there are data on the substance adequate

to support the petition.'' Petitioners may provide citations to

scientific literature, where appropriate. However, submitters are

advised that furnishing copies of supporting articles, reports, or

letters will expedite the review process.

If the Agency receives a petition with insufficient data, EPA will

not commence review until the petitioner submits the missing

information to the best of the petitioner's ability. EPA will inform

the petitioner when the petition is complete for purposes of initiating

the 90-day review period. To the extent the petitioner does not have

the required information, EPA may also seek data from sources other

than the petitioner, including manufacturers or users of products that

contain the substitute. In such cases, section 612(d) explicitly

provides that ``the Administrator shall use any authority available to

the Administrator, under any law administered by the Administrator, to

acquire such information.'' These authorities include section 114 of

the CAA as well as information collection provisions of other

environmental statutes. Where EPA cannot obtain sufficient data within

the statutory 90-day review period, the Agency may deny the petition

for lack of adequate technical support.

D. Criteria for Evaluating Petitions

In evaluating petitions, the Agency will follow the same criteria

as for review of the SNAP Information Notice which notifies EPA of the

intent to introduce a substitute into interstate commerce. This will

ensure that both petitions and notifications are judged by the same

standards.

E. Petition Review Process

1. Petition Submittal

This final rule describes a generic petition process. Petitions

should be sent to the docket number listed in the beginning of this

final rule as well as to the SNAP Coordinator.

2. Petition Reviews

When the Agency receives a petition, it will log the petition into

the SNAP tracking system. If the petition concerns a substitute

previously either found acceptable or unacceptable under the SNAP

program, the Agency will as a courtesy contact the initial submitter of

that substitute.

The Agency will grant or deny the petition within 90 days of

receiving a complete application. If the Agency grants a petition to

add a substitute to the list of unacceptable substitutes or to remove a

substitute from either list, the decision will be made through notice

and comment rulemaking. In such cases, the statute requires EPA to

propose, take comment on, complete final action, and publish the

revised lists within six months of the grant of the petition.

Otherwise, responses to petitions, including explanations of petition

denials, will be included in the next 3-month Federal Register notice

updating the SNAP determinations. Regardless of the final

determination, the Agency will inform petitioners within 90 days

whether their request has been granted or denied.

IX. Listing of Substitutes

A. Overview

This section presents EPA's listing decisions for class I

substitutes in the following industrial sectors: Refrigeration and air

conditioning, foam blowing, solvents cleaning, fire suppression and

explosion protection, sterilants, aerosols, tobacco expansion and

adhesives, coatings and inks. Parts D through K below present a

detailed discussion of the substitute listing determinations for each

of the major use sectors. Tables that summarize listing decisions in

this section are included in appendix B. Listings of substitutes within

the pesticides sector will be added in future notices, as information

on these substitutes becomes available to the Agency. This final rule

focuses on substitutes for class I substances, given the accelerated

production phaseout schedule for class I substances. One of the goals

of SNAP is to encourage transition away from class I substances as

rapidly as possible. SNAP will begin analyzing alternatives to class II

substances in the near future. Results of these analyses will appear in

quarterly updates to the SNAP lists, which will be published in the

Federal Register as described in Sections III.C.4. and VII.A.3.g. of

this final rule.

To develop the lists of unacceptable and acceptable substitutes,

EPA conducted screens of health and environmental risks posed by

various substitutes for class I compounds in each use sector. These

screens are presented in individual background documents entitled

``Risk Screen on the Use of Substitutes for Class I Ozone-Depleting

Substances'' for each use sector. These background documents are

available for review in the public docket supporting this rulemaking.

Whenever the initial risk screen indicated a potential risk, the

substitute was evaluated further to ascertain whether the potential

risk was accurately estimated and if management controls could reduce

any risk to acceptable levels.

Based on these analyses, EPA classified as unacceptable only uses

of substitutes that pose significantly higher human health and

environmental risks than those risks that would accrue through either

continued use of the class I substances themselves or through use of

other available substitutes.

The assessments presented in the background documents are screens

of the comparative risks posed by use of substitutes, not assessments

or rankings of the absolute risks associated with use of each

substitute. Designating a substitute as acceptable does not imply the

absence of risks for that substitute, but rather that the substitute in

question is believed to present lower overall risks than both the class

I compound it is replacing and other substitutes available for the same

end-use. For instance, in some cases, ozone-depleting substances can be

replaced by chemicals with known toxicity or ability to contribute to

ground-level ozone formation. The Agency's risk screen analyzes these

effects, and the SNAP determinations generally describe as acceptable

those substitutes for which risks from replacements would be lower on

an overall basis compared to risks from other existing alternatives, or

for which such risks could be managed by developing and implementing

appropriate regulatory controls. Additionally, in cases where the

Agency has listed a substitute as unacceptable, it has assessed--as

required in section 612--the availability of other substitutes and

concluded that alternatives with reduced overall risk are currently or

potentially available.

As a rule, the Agency did not evaluate the technical performance of

a substitute, since the purpose of the SNAP program is to examine

environmental effects of substitutes identified as being of commercial

interest regardless of technical acceptability. However, in certain

sectors, performance of the substitute does pertain directly to

environmental or health effects. For example, in refrigeration, the

ability of a refrigerant replacement to serve as a coolant will

directly influence the substitute's energy efficiency, which in turn

will affect the substitute's environmental effects. Similarly, in fire

suppression, the ability of a substitute to put out fires and thereby

save human lives will directly affect a substitute's health effects.

Further, in the case of narrowed use listings, the Agency's decision to

grant or deny a narrowed use petition may hinge on the ability of

potential substitut

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