# Protection of Stratospheric Ozone; Final Rule ENVIRONMENTAL PROTECTION AGENCY

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-4753

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** March 18, 1994

## Text

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 regul

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-4753. Public record. Not legal advice.