Vol. 58 No. 90 Wednesday, May 12, 1993 p 28094 (Proposed Rule)
1/11379
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-4625-7]
Protection of Stratospheric Ozone
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
SUMMARY: This action proposes the U.S. Environmental Protection
Agency's (EPA) program for evaluating and regulating substitutes
for the ozone-depleting chemicals being phased out under the
stratospheric ozone protection provisions of the Clean Air Act
(CAA). In section 612 of the amended CAA, the Agency is authorized
to identify and restrict the use of substitutes for Class I
and II ozone-depleting substances where other alternatives exist
that reduce overall risk to human health and the environment.
EPA is referring to the program that would provide these
determinations
as the Significant New Alternatives Policy (SNAP) program. The
intended effect of this action is to expedite movement away
from ozone depleting compounds.
In this Notice of Proposed Rulemaking (NPRM), EPA is both
issuing preliminary decisions on the acceptability of certain
substitutes and introducing its plan for administering the SNAP
program. To arrive at determinations on the acceptability of
substitutes, the Agency completed a cross-media analysis of
risks to human health and the environment from use of various
substitutes in different industrial applications. This analysis
is summarized in today's proposal, and covers substitutes in
the refrigeration, foam blowing, solvents cleaning, fire
extinguishing,
tobacco puffing, adhesives, coatings and inks, aerosols and
sterilants sectors. These sectors comprise the principal industrial
sectors that historically consume large volumes of ozone-depleting
compounds.
DATES: Written comments or data provided in response to this
document must be submitted by June 21, 1993. Any data submitted
can be designated as Confidential Business Information. (See
Section V.C. for more detail.). EPA will conduct a public hearing
on this NPRM on May 28, 1993 beginning at 9 a.m. The record
of this hearing will remain open for 30 days after the hearing
for the submission of rebuttals and other supplementary material.
ADDRESSES: Written comments and data should be sent to 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 3:30
p.m. on weekdays. As provided in 40 CFR part 2, a reasonable
fee may be charged for photocopying. To expedite review, a second
copy of the comments should be sent to Drusilla Hufford,
Substitutes
Analysis and Review Branch, Stratospheric Protection Division,
Office of Atmospheric Programs, Office of Air and Radiation,
401 M Street, SW., 6205J, Washington, DC 20460. Information
designated as Confidential Business Information (CBI) under
40 CFR, part 2, subpart B must be sent directly to the contact
person for this notice. However, the Agency is requesting that
all respondents submit a non-confidential version of their comments
to the docket as well.
The public hearing on this NPRM will be held at the EPA
auditorium
in Washington, DC. Please call the contact person listed below
for details regarding the public hearing.
FOR FURTHER INFORMATION CONTACT: Drusilla Hufford at (202) 233-
9101, Substitutes Analysis and Review Branch, Stratospheric
Protection Division, Office of Atmospheric Programs, Office
of Air and Radiation, Washington, DC.
SUPPLEMENTARY INFORMATION:
I. Overview of This Action
This action is divided into eleven sections, including this
overview:
I. Overview of This Action
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
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
VI. Effective Date of Coverage
A. General Provisions
VII. Notice, Review, and Decision-Making Procedures
A. Substitutes Reviewed under SNAP Only
B. Joint Review of New Substitutes under SNAP and TSCA PMN
Program
C. Joint Review of Substitutes under SNAP and FIFRA
D. Shared Statutory Authority with the Food and Drug
Administration
VIII. Petitions
A. Background
B. Content of the Petition
C. Sufficiency of Data
D. Criteria for Evaluating Petitions
E. Petition Review Process
F. Critical Use Exemption Petitions
IX. Preliminary Listing of Substitutes
X. Additional Information
XI. References
Appendix A to the preamble
Class I and Class II Ozone-Depleting Substances
Appendix B to the preamble
Preliminary Listing Decisions
Appendix C to the preamble
Data Confidentiality Claims
II. Background
A. Regulatory History
The stratospheric ozone layer protects the earth from dangerous
ultraviolet (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 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 final rule promulgated on August
12, 1988; 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 phase-
out schedules for the substances already controlled by the
Protocol.
They also added phase-out requirements for other ozone-depleting
chemicals, including methyl chloroform, carbon tetrachloride,
and other fully-halogenated chlorofluorocarbons (CFCs).
On November 15, 1990, the President signed the Clean Air
Act Amendments of 1990. Title VI, section 604 of the amended
CAA requires a phase-out of CFCs, halons, and carbon tetrachloride
by 2000, which is identical to the London Amendments, but with
more stringent interim reductions. Title VI also differs from
the London Amendments in mandating a faster phase-out 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 lists the Class I and Class
II substances identified in the CAA.
In addition to the phase-out requirements, Title VI includes
provisions to reduce emissions of Class I and Class II substances
to the "lowest achievable level" in all use sectors and to maximize
the use of recycling and recovery upon disposal (section 608).
It also requires EPA to ban 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 action.
In October 1991, the National Aeronautics and Space
Administration
(NASA) announced several 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 per cent 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,
President Bush announced an accelerated phase-out schedule for
Class I substances as identified in the CAA. This schedule has
recently been published in the Federal Register (58 FR 15014;
March 18, 1993). The President also ordered an accelerated review
of substitutes that do less damage to the ozone layer than ozone-
depleting compounds. The existence of the expedited phase-out
schedule and the President's directive regarding alternatives
adds a new 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 consists of members selected on the basis of
their professional qualifications and diversity of perspectives
and provides representation from industry, academia, Federal,
state, and local government agencies, non-governmental and
environmental
groups, as well as international organizations. Since its
formation,
the STOPAC has provided advice and counsel 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. To date, the subgroup on safe alternatives
has 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 of 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 which was published in the Federal Register
on January 16, 1992 (57 FR 1984; January 16).
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
by November 15, 1992, 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
prohibited for specific uses. EPA must publish a corresponding
list of acceptable alternatives for specific uses as well.
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.
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 examines risks of substitutes using
risks from continued use of ozone-depleting compounds as well
as risks associated with other substitutes as reference points.
This evaluation will consider factors such as effects due to
ozone depletion as well as effects due to direct toxicity across
all substitutes. Other risk factors considered include effects
on water and air quality, direct and indirect contributions
to global warming, and occupational health and safety. Where
such effects could be of concern, the evaluation will screen
these effects. However, 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
considered
"safe". Section 612(c) requires the Agency to publish a list
of safe alternatives where the Agency has identified unacceptable
substitutes. The Agency interprets this as a mandate to identify
substitutes that reduce risks when 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 as acceptable even though the compound
may be toxic, or pose other environmental risk of some type.
(3) Restrict only those substitutes that are significantly
worse. As a corollary to the point above, EPA does not intend
to restrict a substitute if it poses only marginally greater
risk than another substitute, all things considered. 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.
(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 characterizations
for the major substitutes now known to the Agency. The results
of the risk characterizations will be used, as discussed in
the previous section, to propose determinations regarding the
acceptability of the substitutes.
(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 some cases, the Agency may base its analysis
on data received on individual products, but the addition of
a substitute to the approved list based on that analysis does
not represent a preference for that company's product over
comparable
products offered by other manufacturers.
(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 increase 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
low risks to human health and the environment. Implementation
of this policy involves three 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.
To expedite implementation of the SNAP program, EPA has
developed
not only a process for examining the alternatives, as discussed
in today's proposal, but has completed an initial analysis of
many key substitutes based on the criteria being proposed. Section
IX summarizes the results of this initial assessment. More detail
on the steps leading up to today's proposal and the anticipated
implementation of the SNAP program is given below.
1. Issue ANPRM and Request for Data
In January of this year, EPA published in the Federal Register
an Advance Notice of Proposed Rulemaking (ANPRM) and Request
for Data (57 FR 1984; January 16, 1992). 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. In some cases, the information provided on
substitutes
did not contain sufficient data for the Agency to immediately
incorporate these alternatives into the risk characterizations.
The Agency is working now to gather additional information on
these alternatives to ensure that they can be included in the
list of reviewed substitutes in the final rule.
Comments on the SNAP program itself focused primarily on
issues such as effective dates, small uses, the desirability
of assured minimum periods of use for substitutes, how mixtures
will be handled by the SNAP program, and how specific the lists
of "acceptable" and "unacceptable" substances will be. These
comments, and the Agency's response to them, are addressed in
later sections of today's proposal.
2. Develop Preliminary Determinations on Substitutes
To arrive at its SNAP determinations, the Agency has been
collecting and evaluating information on substitutes since the
President's signing of the Clean Air Act Amendments in November
1990. In some cases, this information has been furnished directly
by companies manufacturing, selling, or using the substitutes.
In others, the Agency has initiated its own studies to
characterize,
for example, worker exposures where toxicity was anticipated
to present a potential problem. Response to the request for
data in the January ANPRM augmented the Agency's available data,
both by helping to identify substitutes that merit consideration
in the SNAP program and by providing additional information
on substitutes already under consideration.
There are, however, still omissions in the Agency's list
of substitutes under consideration. In some cases, engineering
and use profile data are missing; in others, information on
potential market applications may not yet be available. The
Agency today is repeating the data request issued in the ANPRM,
and is encouraging companies that manufacture substitutes to
provide information.
3. Publish Proposed SNAP Process and Proposed Determinations
This NPRM represents the third implementation step, which
is to describe the proposed structure and process for administering
the SNAP program and to propose determinations on the acceptability
of key substitutes. The notice also contains the proposed
regulatory
language that will serve as the legal basis for administering
and enforcing the SNAP program.
EPA believes that notice-and-comment rulemaking procedures
are necessary to establish these regulations governing the SNAP
program. EPA further believes that rulemaking is also required
to place any substance on the list of prohibited substances,
to list a substance as acceptable only under certain conditions,
or to remove a substance from either the list of prohibited
or acceptable substitutes. EPA requests comment, however, on
the need to remove a substance from the list of acceptable
substitutes
through rulemaking.
EPA does not believe that rulemaking procedures are required
to list alternatives as acceptable with no limitations. Such
listings do not impose any sanction, nor do they remove any
prior license to use a substance. Consequently, once this rule
is promulgated, EPA will be adding substances to the list of
acceptable alternatives without first requesting comment on
new listings.
Because EPA's SNAP regulations are not yet final, however,
manufacturers and users may have additional information that
could help EPA in making this first round of SNAP determinations.
Recognizing this, EPA has elected to propose the list of acceptable
alternatives identified in this notice, and to request public
comment on these listings. This should not in any way be taken
as a precedent for future listings of acceptable substitutes.
Once the SNAP program regulations are finally adopted and EPA
has received SNAP notices from manufacturers and users, EPA
will add substances to the list of acceptable substitutes without
notice-and-comment procedures.
Any approvals or prohibitions on substitutes described in
this notice are preliminary and will not be final until the
SNAP program is promulgated. Even though they are preliminary,
the Agency is issuing the SNAP decisions now because many companies
are awaiting Agency guidance before switching out of
ozone-depleting
substances. The Agency believes that by publishing these
preliminary
determinations, it has met the intent of section 612 to inform
the public of Class I and II substitutes believed to present
minimal risks to human health and the environment. Moreover,
given the accelerated pace of the phase-out of Class I compounds,
the Agency wants to encourage the earliest possible shift to
the alternatives identified on today's list of acceptable
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 types
of changes the Agency expects to make in the future would be
to add new substitutes or sectors to the lists, rather than
to change a substitute's approval status. Further, once a
substitute
has been finally 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. Again, the Agency requests comment on whether formal
rulemaking is necessary to remove a substance from the acceptable
list.
4. Issue Final Regulation
As discussed above, the final rule will promulgate the SNAP
process and the first set of determinations on SNAP substitutes.
The final regulation will address comments that the Agency receives
on today's NPRM, and will also incorporate any further data
on substitutes that are received during the comment period.
5. Maintain and Update SNAP Determinations
Three mechanisms exist for revising or expanding the list
of SNAP determinations published in the 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 notice presents EPA's proposed method for handling
petitions.
The second means of revising or expanding the list of SNAP
determinations is through the notifications, which must be
submitted
to EPA 90 days before introduction of a chemical into interstate
commerce for significant new use as an alternative to Class
I or Class II substances. These 90-day notifications are required
by section 612(e) of the CAA and by EPA regulations today proposed
to be issued under sections 114 and 301 of the Act to implement
section 612(c). In Section VII, this notice discusses the Agency's
proposed approach for processing these notifications, including
a proposed strategy for integrating the 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 action also explain how the
Agency will address the overlap between SNAP regulations and
regulations issued under other titles of the Clean Air Act.
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.
6. Perform Outreach and Operate Clearinghouse
Outreach and the clearinghouse comprise the technical assistance
component of the SNAP program. The purpose of this effort is
to provide information for companies to use in selecting among
the approved substitutes. Section VII.A.3.f. describes the Agency's
proposed approach for establishing the clearinghouse and performing
outreach.
IV. Scope of Coverage
A. Definition of Substitute
1. Statutory Language
Based on the language of section 612(a) of the CAA, the Agency
is proposing in the SNAP program to define a "substitute" as
any chemical, product substitute, or alternative manufacturing
process, whether existing or new, that could replace a Class
I or Class II substance. While subsequent subsections of section
612 refer only to "substitute substances" or "substitute
chemicals,"
EPA is proposing a definition that interprets these provisions
as incorporating the general definition of substitute presented
in 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, section 612 confers
the legal authority to allow the use of a substance only under
certain use conditions, such as with mitigation measures. EPA
only intends to use this authority where a viable substitute
exists, but would otherwise have to be disallowed because of
risk associated with its uncontrolled use. EPA anticipates imposing
use conditions only in the rare instances where clear regulatory
gaps exist, and where an unreasonable risk exists in the absence
of any condition.
In imposing conditions, EPA does not intend to preempt other
regulatory authorities, such as those exercised by the Occupational
Safety and Health Administration (OSHA), or other 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. Once
existing gaps are filled, EPA will rescind any conditions which
have become redundant. 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
below in section VII.A.
The Agency, however, requests comment on the general issue
of the need for use conditions. In particular, EPA requests
comment on whether section 612 in fact confers upon the Agency
the authority to go beyond the listing of acceptable and
unacceptable
alternatives and to set such use conditions. Further, EPA requests
comment on the capability and practicality of EPA enforcing
use conditions which may, for example, closely resemble workplace
safety standards, which are typically within the enforcement
purview of other regulatory authorities.
EPA also requests comment on whether, when an unreasonable
risk might exist due to a gap in regulatory coverage, the
appropriate
means to address these risks is through the existing regulatory
framework of other federal authorities. For example, rather
than using EPA's use conditions to address existing gaps in
workplace safety standards, EPA could refer the matter to the
appropriate OSHA authorities and request appropriate action
to mitigate an otherwise unreasonable risk.{1}
³{1} 29 U.S.C. 654, OSHA General Duty Clause, requires
³that each employer "shall furnish to each of his
employees
³employment and a place of employment which are free
from
³recognized hazards that are causing or are likely to
³cause death or serious physical harm to his employees.
³* * *"
Alternatively, where the length of time required to address
a problem under another authority may be unacceptably long given
the nature of the risk, there may be cases in which EPA would
simply consider unacceptable the use of a given substitute,
pending the development of a regulatory framework to control
the risk it poses in its use as a substitute for an ozone-depleting
compound.
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 substitute may be "currently or
potentially available." The Agency is proposing to define as
potentially available any alternative that the Agency reasonably
believes to be technologically feasible and economically viable,
even if not all testing has yet been completed and it is not
yet produced and sold in commercial quantities. EPA solicits
comment on this approach.
The language included in section 612 is written broadly to
allow for an all-encompassing 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" based on section
612.
2. Additional Clarification
a. Chemicals Already Listed as "Existing" under TSCA. Many
commenters have expressed the view that any compound already
existing (e.g., listed on the TSCA inventory, either through
the grandfathering provisions or by undergoing new-chemical
review under section 5 of TSCA) is not subject to review under
section 612. Nothing on the face of section 612(c), however,
suggests that any "new" compound can be considered a substitute
for purposes of that subsection. Moreover, 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, 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, are subject to SNAP review. This
regulatory purview would thus necessarily extend to those chemicals
already listed on the TSCA inventory. EPA believes SNAP review
is critical given the differing statutory objectives of TSCA
and the CAA, and the new and expanded applications of many existing
chemicals as Class I and Class II replacements, which could
alter existing release and exposure profiles.
b. Expanded Use of Existing Alternatives. There has also
been some question regarding whether an existing alternative
already being sold commercially (e.g., use of semi-aqueous cleaners
in the electronics industry) would be subject to review under
section 612. The Agency believes that they would. Because of
the phase-out, uses of existing substitutes can be expected
to increase significantly beyond current consumption. This
increased
use could translate into greater releases and risks, and existing
substitutes are therefore subject to SNAP approval where their
use could significantly expand to new users or product lines.
Users should note that preliminary SNAP determinations discussed
in Section IX of this action demonstrate that with few exceptions,
all substitutes already on the market meet the conditions for
SNAP approval.
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. 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, Class II substitutes should also
be reviewed.
To obtain the data necessary to analyze Class II substitutes,
the Agency is proposing to use statutory authority provided
in sections 114 and 301 of the CAA with 612(c). These sections
together authorize the Administrator to promulgate regulations
needed to require companies to provide information EPA may
reasonably
require to identify acceptable and unacceptable substitutes
for Class II substances. EPA proposes to exercise this authority
so that Class I and Class II substitutes are subject to the
same information reporting requirements and listing process.
d. Designation of Class I and Class II Chemicals as Substitutes.
EPA believes that the review authority under section 612 extends
also to use of Class I and Class II chemicals as substitutes,
even though these chemicals are subject to the phase-out provisions
of the CAA. While some comments received by the Agency in response
to the ANPRM question EPA's authority under section 612 to review
Class I and Class 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, they are subject to review under
the SNAP program just as any other substitute. Given the potential
for the Class I and Class II 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 warranted under section
612.
e. Alternative Substances and Manufacturing Processes. Section
612(c) broadly charges EPA to identify alternatives to ozone-
depleting substances. For example, EPA believes that alternative
substances can include no-clean fluxes for solvent cleaning,
substituting for solvents using Class I or II compounds. Several
commenters disagree with this interpretation of the language
in section 612. However, EPA believes it appropriate to consider
substitute substances in its reviews under the SNAP program,
since many of these alternatives are viable substitutes and
could reduce overall risks to human health and the environment.
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. Section 612's reference to "alternative", instead
of "alternative substance", or "alternative chemical", implies
a statutory intent that "alternative" be read broadly.
EPA will encourage, where appropriate, alternative processes
that reduce environmental and human health effects. In many
applications, reliance on alternative processes and/or equipment
may be associated with the use of 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. Such joint filings will
provide the most comprehensive data on an alternative and its
effect on human health and the environment.
f. Feedstock Substitutes. Other commenters have questioned
the applicability of section 612 to substitutes that could replace
Class I chemicals which are used solely as intermediates in
the production of other chemicals. To the extent that any feedstock
substitutions occur, the Agency believes that there will be
no 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. For instance, in analyzing uses
of carbon tetrachloride as a feedstock, the Agency determined
that greater than 99 per cent of this chemical was consumed
in the production process. The Agency is therefore proposing
that feedstock substitutes be exempt from reporting and review
under section 612.
g. Second-Generation Substitutes. A key issue is whether
there exists a point at which an alternative should no longer
be classified as a Class I and Class II substitute as defined
by section 612. The Agency believes that as long as Class I
and Class II chemicals are being used, any first-generation
substitute designed to replace these applications is subject
to the regulatory provisions implemented under section 612.
However, the Agency is proposing today that second-generation
replacements, if they 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.
Several commenters agreed with the need to exempt second-
generation substitutes. On the other hand, EPA is proposing
that second-generation substitutes replacing first-generation
substitutes that deplete stratospheric ozone (e.g., HCFCs) should
be bound by the same notification and review requirements under
section 612 as first-generation substitutes.
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. However, future
substitutions to replace the HFC would be exempt from reporting
under section 612 because the first-generation alternative did
not deplete stratospheric ozone. However, if a Class I (interim
only) 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 II chemical.
h. Formulation Changes Accompanying the Use of Class I and
Class II Substitutes. In general, the Agency believes that changes
in formulation needed to accommodate replacement of Class I
and II compounds are not subject to the provisions of section
612. Such auxiliary changes may be necessary, for example, when
a new blowing agent in foam blowing necessitates the replacement
of the catalyst formerly used in conjunction with the Class
I blowing agent.
This position was also supported by comments received in
response to the ANPRM. However, if the potential SNAP notice
submitter has reason to believe that such changes will
significantly
influence the environmental and human health risk characteristics
associated with the use of any Class I or Class II substitute,
this must be communicated to the Agency. Alternatively, if EPA
has reason to suspect such concerns may exist, it may request
the review of any such changes in formulation in connection
with review of substitute compounds.
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 notice, pursuant to sections 114, 301 and 612(c), producers
of Class II substitutes must abide by the same reporting
requirements.
Under the authority of sections 114, 301(a) and 612(c), EPA
is proposing 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 in the following section, IV.A.2.j.(2). To analyze
alternative substitutes under section 612(c), the Agency finds
it necessary under section 301(a) to require all producers of
substitutes, whether a chemical manufacturer, formulator, or
end-user, to submit information under section 114 describing
such substitutes. 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. This is
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
a. Chemical Manufacturers. Chemical manufacturers making
a substitute for direct commercial sale are required to notify
the Agency about the existence of that substitute. This requirement
is especially applicable to chemical manufacturers that have
developed new compounds for specific, targeted uses as substitutes
for Class I or II substitutes. For instance, if a chemical
manufacturer
intends to market a new chemical as a substitute foam blowing
agent to companies that manufacture insulation products, that
manufacturer would be required to notify the Agency about the
existence of the substitute. The reporting requirement would
also apply to chemical manufacturers that intend to sell an
existing chemical to a particular user group.
b. Formulators. A formulator is a person or organizational
entity 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 approved 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 example by offering a tailored formulation or blend for
an industrial cleaning process, these formulators would be subject
to reporting requirements as outlined in this proposal. 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, the manufacturer would then be responsible for meeting
reporting requirements on the chemical. Similarly, if an end-
user has developed a process to replace an ozone-depleting
compound,
this end-user would be required to provide EPA with information
on the substitute.
The simplest approach to allocating responsibility for reporting
requirements would be to place the reporting burden in all cases
on chemical manufacturers. However, the Agency believes that
the approach outlined above provides the best correlation between
burden for reporting and benefit from securing approval for
a substitute. For instance, it would be inappropriate to require
a manufacturer of a chemical in wide-spread industrial use to
report on every possible application for that chemical as a
substitute. The Agency requests comment on this aspect of the
proposed reporting requirements.
c. End-users. In general, end-users of substitutes will not
be obligated to meet the reporting requirements discussed in
this proposal, except in rare cases where the end-user and the
producer of the substitute are one and the same company and
the company intends to sell that substitute into inter-state
commerce. While the Agency expects that this situation will
occur only seldom, it has already received notice from several
large companies who developed a substitute for use in their
own manufacturing process and subsequently decided to offer
that substitute for commercial sale. The Agency hopes that
evaluating
and listing such substitutes will help provide other potential
end-users with information on viable substitutes, rather than
stifling research and development innovations by end-users.
The Agency solicits comment on this aspect of today's proposal.
3. Exemptions from Reporting
The Agency has identified several situations in which
notification
under the provisions of section 612(e) will not be required.
These exemptions from reporting are discussed below.
a. Substitutes Already Listed by EPA. As part of today's
proposal, the Agency has already completed a preliminary review
of several Class I and Class II alternatives and has proposed
that these substitutes be either acceptable or unacceptable.
In preparing these proposed determinations, the Agency evaluated
information either on file or supplied in response to the ANPRM
published in the Federal Register on January 16, 1992. The
preliminary
substitutes list and the supporting risk screen are described
in more detail in Section IX. No submission is needed for those
substitutes and applications already proposed as acceptable
in today's NPRM.
Any specific comments on the proposed substitute determinations
found in this action should be provided to the Agency, along
with any supporting information, during the comment period.
If information is not received by the Agency during the comment
period, a formal submission to add substitutes will be required
once the final rule is promulgated.
b. Small Sector and Application Use. Most ozone-depleting
substances have been or are currently used in large industrial
sectors such as refrigeration or fire extinguishing. However,
there are also numerous small uses of Class I or II substances
that fall outside of these major use sectors. Most of these
small uses of ozone-depleting compounds are for solvents in
applications other than industrial cleaning operations, such
as solvents used as book preservers, drilling and machining
coolants, extraction or bearer media, or mold release agents.
While small-use applications for Class I and Class 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, including the solvents sector,
these varied but small volume uses comprise in aggregate at
most seven per cent of total U.S. consumption of ozone-depleting
substances.
Because 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 or sector, the Agency
proposes to focus the SNAP determinations on large-volume
applications
in major use sectors. Given the breadth of EPA's required "overall"
risk assessment, the imposition on small sectors, and on small
uses within any sector, of a full SNAP submission for each small
use seems unjustified by the potential for risk posed by these
small uses.
Moreover, a key policy interest of EPA's in designing and
implementing the SNAP program is promoting the quickest possible
shift from the phase-out compounds 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 constitute the bulk of the problem SNAP is
aimed at ameliorating.
Accordingly, eight major industrial use sectors are covered
in today's proposal. They are refrigeration, foam blowing, fire
extinguishing, solvent cleaning, adhesives, coatings, and inks,
aerosols, sterilization, and tobacco puffing. Analysis of
substitutes
in a ninth sector, pesticides, will be completed, and the resulting
decisions will be added to the SNAP determinations in the final
rule. 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 in future receives additional data
indicating
that inclusion of additional sectors is warranted based on the
potential for high risks to human health and the environment.
Further, the Agency does not plan individual analyses of
all small uses within major industrial sectors. Specifically,
EPA is today proposing not to review any uses of substitutes
of less than 10,000 lbs per year within a sector as defined
in the SNAP determinations. Companies producing, formulating
or using substitutes for ozone-depleting compounds in annual
quantities under 10,000 lbs per year need not notify EPA of
their activities under SNAP. However, the Agency encourages
companies to maintain documentation describing the basis for
their view that any substitute being used meets this small use
definition. This documentation could be necessary in the event
the Agency receives a petition to add such substitutes to its
evaluation.
The Agency's decision to focus the SNAP program on high-volume
sectors does not imply the complete absence of any risk from
use of substitutes in small use applications. Instead, the Agency
believes that focusing the listing decisions on the largest
sectors and uses will allow the Agency to target its regulatory
efforts to those applications that offer the maximum risk reduction
potential. If other sectors are subsequently added to the Agency's
analysis, the Agency will provide notice in the Federal Register
of the need to furnish the Agency with data on substitutes.
The Agency requests comment on this approach to small sectors
and small uses within all sectors of substitutes for
ozone-depleting
compounds. In particular, EPA requests comment and data on risks
associated with small sector and small volume uses.
c. Test Marketing. Use of alternatives for the sole purpose
of test marketing is exempt from any reporting requirements
under section 612. However, once a company decides to sell an
alternative as a Class I or II substitute, it must provide the
Agency with 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 Class 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. When submitting the TSCA application, it
would also be advantageous if the producer would notify EPA's
Office of Air and Radiation; however, such notification is not
mandated under section 612.
d. Research. Substitutes manufactured or imported solely
for research and development are exempt from notification
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 section 720.36 of the PMN rule
(40 CFR Part 720) are in effect. The Agency solicits comment
on appropriate use levels to allow in research applications.
e. Second-Generation Substitutes. As discussed in section
IV.A.2.h., substitutes replacing first-generation alternatives
that are not ozone-depleting chemicals are exempt from any
additional
reporting and review under section 612. However, if the second-
generation substitute is replacing a compound that contributes
to stratospheric ozone depletion (e.g., a HCFC), information
must be submitted to the Agency for review under the SNAP program.
f. Formulation Changes. As discussed in section IV.A.2.i.,
the Agency is proposing that changes in formulation that accompany
the use of substitutes for Class I and Class II substances need
not be reviewed under section 612. 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 Class II substitute.
Also, the Agency reserves the right to examine formulation changes
if a problem appears to exist.
g. Substitutes Produced for Export. Substitute manufacturers
producing solely for export and use by non-U.S. entities outside
the U.S. are not subject to the requirements of section 612.
EPA believes that its authority under section 612 extends only
to use of substitutes in areas under the jurisdiction of the
United States government, regardless of their place of manufacture.
This exemption does not apply to substitutes introduced as
replacements
for Class I and II chemicals offered for sale or use 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, since 612(c) applies to use rather than to manufacture
of substitutes.
h. Substitutes Used as Feedstock. The Agency is proposing
to exempt substitutes used as feedstock from the reporting and
review requirements of section 612. Because feedstock chemicals
are largely consumed as intermediates, except for trace amounts,
the Agency does not believe that such substitutions would cause
any increase in ozone depletion or other adverse effects on
human health and the environment.
V. Information Submission
A. Overview
To develop the list of unacceptable and acceptable substitutes
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. This "overall"
examination
will consider a wide range of health and environmental factors.
In the section that follows, the Agency presents information
that will be required in the SNAP program notice to help EPA
evaluate Class I and Class II substitutes. A copy of the
notification
form can be obtained from the SNAP coordinator at the address
listed in the beginning of this action.
B. Information Required
1. Name and description of the substitute. The substitute
should be identified by its (1) commercial name, (2) chemical
name, (3) trade name(s), (4) identification numbers (e.g., Chemical
Abstract Service (CAS) registry, National Institutes of
Occupational
Safety and Health Registry of Toxic Effects of Chemical Substances
(NIOSH RTECS), EPA hazardous waste identification number, OHM-
TADS, DOT/UN/NA/IMCO shipping, HSDB, National Cancer Institute
(NCI), (5) chemical formula, and (6) chemical structure.
2. Physical and chemical information. Key properties needed
to characterize the substitute are: molecular weight; physical
state; melting point; boiling point; density; odor threshold;
solubility; partition coefficients (Log Kow, Log Koc); vapor
pressure; and Henry's Law Constant.
3. Substitute applications. Identification of the applications
in which the substitutes are likely to be used is required.
It is essential to provide a complete list of potential uses
because the substitute listing required by section 612(c) is
specific to application.
4. Process description. For each application identified,
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 ozone depletion
potential (ODP) of substitute chemicals 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 total global warming potential (GWP) of the substitute in
its particular application (e.g., as a refrigerant, foam blowing
agent, etc.). The total GWP considers both direct and indirect
effects. Direct effects means the direct global warming effects
of using a substitute. 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
effects 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 or
demand 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 effects 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 range-finding 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 (for example, rats
or mice). For substitutes that are being evaluated as fire
suppressants,
a cardiotoxicity study, usually 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 sufficiently characterize
aquatic toxicity, both acute and chronic toxicity data for a
variety of species are required. The Agency is proposing 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).
Other relevant hazard information and data summaries, such
as the Material Safety Data Sheets, 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 the actual studies are not submitted, however, the submitter
must provide sufficiently clear references or citations 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. The Agency is proposing that submitters providing
information on new chemicals for joint review under the TSCA
and SNAP programs adhere to the TSCA minimum testing requirements
described in TSCA section 4.
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 are required. Specifically, data on flash
point and flammability limits are needed, as well as information
on the procedures used for determining the flammability limits.
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
appropriate. Detail on any suggested abatement techniques to
minimize the risks associated with the use of flammable substances
or blends should also be provided. The Agency recognizes that
many promising alternatives may be considered marginally flammable,
but can be used safely and effectively.
10. Exposure data. The submitter must provide 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 application,
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. Any information on any 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
also 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. Data on the cost (capital and operating)
and estimated life of the technology modifications should also
be submitted. These economic data are essential to understanding
the near-term potential of using an alternative.
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 is also required. This information can be presented in
several ways, for example: a percentage of existing nationwide
use of Class I or Class II chemicals in a particular application;
number of units/products to be produced; or pounds of substitute
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(s) are regulated under other statutory authorities,
in particular the Clean Water Act, 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, as well as 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 being required in the
SNAP program notice to the Agency as part of past regulatory
and information-gathering activities. In this case, to minimize
reporting burden, the submitter 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; and a document-control number, if assigned
(e.g., a PMN number). If the submitter cannot provide references
for data sent previously to the Agency, he or she should include
all required information in the SNAP notice. To facilitate review,
reports already submitted to the Agency as part of other regulatory
submissions should be resubmitted if the original information
was claimed as CBI.
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.
All submissions must be provided in three complete identical
copies. If information is to be claimed as confidential, all
confidential information must be excised from the third copy,
which will be placed in the public docket. When portions of
a submission are claimed as confidential, the first two copies
will include the confidential material. If no claims of
confidentiality
are made for the submission, the third copy should be identical
to the other two. (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. 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. Therefore, 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.
2. Substantiation of Confidentiality Claims
At the time of submission, EPA requires a substantiation
of any confidentiality claims. 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.
The submitter should be advised that under the Clean Air Act
section 114(c), emissions data may not be claimed as confidential.
Moreover, there are further instances in which confidentiality
assertions may later be reviewed even when confidentiality claims
are received. These are provided in the provisions of 40 CFR
part 2, subpart B. The submitter will be contacted as part of
this evaluation process. However, if required substantiation
is not provided along with the submission of information claimed
as confidential, EPA may make the complete submitted information
available to the public without further notice to the submitter.
3. Confidential 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 is also submitted under TSCA or FIFRA, because of
specific disclosure provisions in those statutes. However, any
information other than emissions data contained in the toxicity
study that 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., the Agency intends
to publish quarterly notices in the Federal Register updating
the list of acceptable and unacceptable alternatives. The Agency
is proposing that if the name of a specific chemical 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
chemical, 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.
VI. Effective Date of Coverage
A. General Provisions
In general, EPA's rules listing substitutes as unacceptable
become effective thirty days after final rulemaking. However,
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 uses of
particular substitutes by setting the effective date of
unacceptability
listings at some future date.
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
(D.C. 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.
In keeping with the discussion above, then, for restrictions
on use of unacceptable substitutes, the Agency will in selected
cases set the effective date differently for each banned
substitute.
The effect of this will be in these selected cases to tailor
the implementation dates to individual applications. EPA will
establish these effective dates in the rulemakings on each
substitute
to be banned.
Setting effective dates for specific chemicals and uses will
allow the Agency to avoid penalizing those who in specific
applications
may have already invested in good faith in alternatives the
SNAP program ultimately prohibits. For example, the Agency in
this action is proposing to find unacceptable the use of HCFC-
141b in certain 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 increased
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 is today proposing a tailored effective date for certain
uses of HCFC-141b. See the listing determination narrative
discussion
in Section IX, 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 equipment.
Until the Agency reaches a final decision restricting the
use of a substitute, vendors are not barred from selling such
substitutes. However, manufacturers, formulators, users or other
individuals involved in sale or use of a substitute are still
required to notify the Agency of any sale or use of a Class
I or Class II substitute as required by the SNAP program.
This action includes a proposed list of acceptable substitutes
and a proposed list of banned substitutes. The list of restricted
substitutes becomes binding 30 days after the date of publication
of the final rule. In contrast, the list of acceptable substitutes
is not binding, but rather is furnished for the purpose of
assisting
users in understanding the full range of available, acceptable
substitutes in each application. Before issuing the final rule,
the Agency hopes to supplement the list of acceptable substitutes
with substitutes not yet on the proposed list.
As noted above, the Agency does not believe determinations
that substitutes are acceptable need be made through rulemaking.
Consequently, EPA believes that it is within its discretion
to supplement the list of acceptable substitutes upon making
determinations consistent with the criteria to be established
in this rulemaking. In the interest of informing users as soon
as possible of acceptable substitutes, EPA expects to add to
the list of substitutes those substitutes for which it can make
such a determination during the pendency of the rulemaking,
consistent with the criteria promulgated.
The Agency therefore encourages vendors and users of substitutes
to use this opportunity to provide EPA with information necessary
to issue a SNAP determination. Many potential users of substitutes
have asserted that they want the benefit of EPA's SNAP
determinations
when transitioning out of Class I and Class II compounds. In
addition, vendors of substitutes have also claimed they will
derive significant benefits from having their substitutes added
to the SNAP lists of approved substitutes, where possible.
VII. Notice, Review, and Decision-Making Procedures
The purpose of this section is to summarize the proposed
procedures for submitting the required information to the Agency,
and the steps EPA will take in reviewing SNAP program submissions,
and making determinations based on them. 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 have received approval 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 the submission
and review process for alternatives that fall into this category
in greater detail. In other cases, a substitute will require
approval under section 612 as well as relevant provisions of
TSCA and FIFRA. In these cases, any substitute that is a new
chemical (i.e., not currently listed on the TSCA inventory)
must be submitted to the Agency for review under the SNAP program,
as well as the PMN program. Section VII.B. describes steps for
this review in more detail. For alternatives to Class I and
Class 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. EPA
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 the submitter and the
Agency.
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 from the process as described in
section IV.B.3., Exemptions from Reporting, a SNAP notice must
be submitted.
See the accompanying hardcopy volume for non-machine-readable
data that appears at this point.
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 guidance manuals;
(4) serve as the initial point of contact when the notice is
submitted; and (5) assign a SNAP program tracking number to
the notice once it is received by the Agency. A copy of the
SNAP program notice may be obtained from the SNAP Coordinator.
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 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 in order to fulfill the purpose of section
612(c). EPA intends to review these chemicals within a 90-day
period to ensure prompt response for manufacturers initiating
production of substitutes. EPA's 90-day review period for SNAP
submissions will begin once EPA receives a submission that includes
data that are adequate, 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) Letter of
Receipt. The SNAP Coordinator will send a letter of receipt
to the submitter once the Agency receives the SNAP submission.
(2) Initial Review of Submission. Once received, the SNAP
Coordinator will review the 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 the substantiation provided for any claim
for confidentiality of information. The 90-day review period
will not commence until EPA judges the submission complete,
although manufacturers may begin marketing chemicals 90 days
after submitting their notification to EPA. Once the data
supporting
the SNAP notice are deemed adequate, the SNAP Coordinator will
assign to the SNAP notice a tracking number, and EPA's formal
90-day review period will begin.
c. Determination of Data Adequacy. As mentioned above, as
part of reviewing the SNAP submission, the Agency will complete
a determination of the scientific and technical adequacy of
the data supporting the application. The Agency will issue this
determination within 15 working days after receipt of the
application.
Any time 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 place the burden on 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 chemical 90 days
after notifying the Agency.
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 substitute may be
unacceptable, the Agency may exercise the option of proposing
to list the substitute as unacceptable 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 learning of 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.
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,
the Agency may contact the submitter for additional 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 the detailed analysis
completed during this stage of review.
f. Vendor Lists. 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 approved 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 Class II compounds. The Agency solicits comment
on this aspect of today's proposal.
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 notification requirement
will take the form of either adding substances to the list of
acceptable substitutes or of proposing to add them to the list
of unacceptable substitutes. The former, as discussed in greater
detail below, will be listed in a quarterly update of SNAP
determinations
which EPA will publish in the Federal Register. The latter will
be made final through rule-making under section 307(d).
(2) Communication of SNAP Determination to the Submitter.
Once 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 conditions are attached
to the approval of a substitute. Companies may continue
uninterrupted
sale or manufacture of their substitutes until the Agency places
a substitute on the list of unacceptable substitutes as a result
of rulemaking. Sale or manufacture may continue if the Agency
fails to reach a decision or notify the submitter of that decision
within 90 days of initial 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 is proposing to publish in the Federal Register a
complete list of the acceptable and unacceptable alternatives
that have been 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 various outreach programs, as discussed in the next section,
as well as through the stratospheric ozone program hotline,
which the Agency has already established.
(b) Outreach and Clearinghouse
Section 612(b) requires the Administrator to assist users
in identifying alternatives to Class I and II compounds. The
Agency has long operated an outreach program for users of ozone-
depleting compounds, and this new mandate along with the
accelerated
phase-out of Class I and II substances adds impetus to these
efforts.
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 Class II chemicals. The clearinghouse
will distribute information on those substitutes that are approved
under the SNAP program. For the convenience of companies wishing
to identify substitutes with low relative environmental risks,
the Agency will maintain a list of vendors selling substitutes
that meet EPA's criteria for approval, as discussed in section
VII.A.3.f.
In addition, the Agency is proposing to 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. The Agency requests comment on
this proposed approach to providing the public with information
on available alternatives.
4. Decision-Making Framework
a. Decisions by Substitute and Use. As required by section
612(c), the Agency must publish a list of substitutes prohibited
under the SNAP program and a list of acceptable alternatives
for particular applications. Given that environmental exposure
and risk profiles can change significantly from one application
to the next, it is essential to evaluate and list substitute
decisions in the context of their intended use. The Agency has
initially identified a number of use sectors by which to list
substitutes, and Section IX provides preliminary risk management
decisions for many substitutes in each of the principal use
sectors. Other substitutes in each of these sectors exist as
well, and these substitutes will be covered in subsequent analyses
undertaken in the SNAP program.
In listing the substitutes, the Agency will be as specific
as possible, by providing exact chemical names of substitutes.
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. Yet 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.
b. Decision Categories. Under section 612, the Agency has
considerable discretion in the risk management decisions it
can make in SNAP. The Agency has identified several possible
decision categories, as described below. However, these types
of risk management decisions should not be construed as comprising
all possible options that the Agency will exercise under section
612. Depending on the particular characteristics of the submission,
alternative approaches may be warranted.
(1) General Acceptance. Where the Agency has reviewed a
substitute
and found no reason to prohibit its use, it will list the
alternative
as acceptable for the applications listed. 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) Approval Subject to Conditions. After reviewing a notice,
the Agency may determine that a substitute is acceptable only
if certain conditions are met. The Agency cannot predict at
this time all necessary restrictions, but already anticipates
some conditions based on substitute reviews already completed.
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. Alternatively, EPA may approve
a compound not for general use, but for use only in certain
narrow applications. Clearly, any limitations imposed will depend
on the risks involved and the substitute and application in
question. To provide adequate opportunity for comment by the
regulated community, EPA will complete notice-and-comment
rulemaking
before promulgating any finding to approve a substitute subject
to a condition on use.
In implementing its use of conditions, the Agency has sought
to avoid overlap with other existing regulatory authorities.
EPA has taken a number of steps to mitigate this potential for
duplication. First, EPA intends to limit the use of conditions
to cases in which clear regulatory gaps exist. Second, these
existing regulatory gaps must render the use of a substitute
an unreasonable risk in the absence of any additional controls.
Third, in the limited cases in which conditions may be necessary,
the Agency will impose them only after going through formal
notice-and-comment rulemaking. Finally, the Agency intends to
withdraw existing conditions when they are superseded by
appropriate
regulatory controls under other authorities.
The Agency, however, requests comment on the general issue
of the need for use conditions. In particular, EPA requests
comment on whether section 612 in fact confers upon the Agency
the authority to go beyond the listing of acceptable and
unacceptable
alternatives and to set such use conditions. Further, EPA requests
comment on the capability and practicality of EPA enforcing
use conditions which may, for example, closely resemble workplace
safety standards, which are typically within the enforcement
purview of other regulatory authorities.
EPA also requests comment on whether, when an unreasonable
risk might exist due to a gap in regulatory coverage, the
appropriate
means to address these risks is through the existing regulatory
framework of other federal authorities. For example, rather
than using EPA's use conditions to address existing gaps in
workplace safety standards, EPA could refer the matter to the
appropriate OSHA authorities and request appropriate action
to mitigate an otherwise unreasonable risk.{2}
³{2} 29 U.S.C. 654, OSHA General Duty Clause, requires
³that each employer "shall furnish to each of his
employees
³employment and a place of employment which are free
from
³recognized hazards that are causing or are likely to
³cause death or serious physical harm to his employees.
³* * *"
Alternatively, where the length of time required to address
a problem under another authority may be unacceptably long given
the nature of the risk, there may be cases in which EPA would
simply consider unacceptable the use of a given substitute,
pending the development of a regulatory framework to control
the risk it poses in its use as a substitute for an ozone-depleting
compound.
For example, in this action, EPA has proposed conditions
on the acceptability of certain halon substitutes when used
as total flooding agents in normally occupied areas. EPA has
imposed these conditions because of the risk of cardiotoxic
levels of exposure to personnel in areas where substitute agents
may be discharged in the event of fire. Existing OSHA standard
1910.160 applies certain general controls to the use of fixed
extinguishing systems in occupied workplaces, whether gaseous,
dry chemical, water sprinklers, etc., and EPA has not reproduced
those. These include, for example, the requirements for discharge
and pre-discharge alarms, and availability of Self Contained
Breathing Apparatus (SCBA) for emergency entry into an area
where agent has been discharged.{3}
³{3} 29 CFR 1910.160(b) includes general provisions to
³ensure the safety of all fixed extinguishing systems.
³Paragraph (c) stipulates requirements for systems with
³"potential health and safety hazards to employees" such
³as might be posed by gaseous agents.
³ (b)(3) ``The employer shall provide a distinctive
alarm
³or signaling system * * * capable of being perceived
³above ambient noise or light levels * * * to indicate
³when the extinguishing systems is discharging.
Discharge
³alarms are not required on systems where discharge is
³immediately recognizable.''
³ (b)(4) ``The employer shall provide effective
safeguards
³to warn employees against entry into discharge areas
³where the atmosphere remains hazardous to employee
safety
³or health.''
³ (b)(5) ``The employer shall post hazard warning or
³caution signs at the entrance to, and inside of, areas
³protected by fixed extinguishing systems which use
agents
³in concentrations known to be hazardous to employee
safety
³and health.''
³ (b)(6) ``The employer shall assure that fixed systems
³are inspected annually * * * to assure that the system
³is maintained in good operating condition.''
³ (b)(10) ``The employer shall train employees
designated
³to inspect, maintain, operate, or repair fixed
extinguishing
³systems. * * *''
³ (b)(17) ``The employer shall provide and assure the
³use of personal protective equipment needed for
immediate
³rescue of employees trapped in hazardous atmospheres
³created by an agent discharge.''
³ (c)(3) ``On all total flooding systems the employer
³shall provide a pre-discharge employee alarm * * *
which
³will give employees time to safely exit from the
discharge
³area prior to system discharge.''
While section 1910.162 can apply generally to gaseous agents,
it includes cardiotoxic levels specific to Halon 1301. Section
1910.162 paragraphs (b)(5) and (b)(6) provide alternative workplace
requirements based on specific design concentrations of Halon
1301. (These design concentrations are not identified as the
cardiotoxic NOAEL or LOAEL, so one cannot generalize a rule
for use with alternative agents.) For this reason, EPA is concerned
that halon substitute agents could be used in the absence of
enforceable compound-specific cardiotoxic exposure levels. Should
OSHA create compound-specific cardiotoxicity values to be applied
to the use of halon substitutes as gaseous total flooding agents
in occupied spaces, these conditions would no longer be necessary
and EPA would rescind them.
However, EPA is also aware that existing OSHA regulations
may provide adequate coverage against exposure to toxic levels
of agents or their decomposition products. Section 1910.162
(b)(3) states, "(t)he employer shall assure that employees are
not exposed to toxic levels of gaseous agent or its decomposition
products," and paragraph (b)(4) states, "(t)he employer shall
provide a distinctive pre-discharge employee alarm * * * when
agent design concentrations exceed the maximum safe level for
employee exposure." EPA invites comment on the adequacy of 1910.162
(b)(3) to provide workplace protection against toxic exposures
to agents that differ from Halon 1301.
(3) Substitutes Pending Completion of Review. The Agency
will describe submissions for which it has not yet reached a
final decision as pending. For all substitutes in the pending
category, the Agency will contact the submitter to determine
a schedule for providing the missing information if the Agency
needs to extend the 90-day review period. EPA will use the
authority
under section 114 to gather this information, if necessary.
(4) General Prohibition. The Agency has the authority under
section 612(c) to prohibit the use of a substitute believed
to present adverse effects to human health and the environment
where alternatives that reduce overall risk are available. The
Agency will only use this provision where it has identified
other substitutes that are currently or potentially available
and that have lower overall risks. Substitutes will be listed
as unacceptable through the rulemaking process.
(5) Prohibition with Limited Exemptions for Critical Uses.
In some applications, even though the Agency restricts the use
of a substitute based on the potential for adverse effects,
it may be necessary to grant a limited number of exemptions
because of the lack of alternatives for specialized uses within
the general application area. The Agency will refer to such
exemptions as "critical use exemptions." For example, the Agency
could list a substitute as generally unacceptable for solvent
applications, but allow for limited exemptions for critical
uses within the sector of solvent cleaning. These critical use
exemptions will be granted only for the period necessary to
develop and implement alternatives not yet available.
At this time, the Agency cannot know and list all critical
use applications that will be exempted. Section VIII.F. discusses
the petition process for critical use exemptions in more detail.
Critical use exemptions will be granted through notice-and-comment
rulemaking.
c. Time Certainty of Decisions. In response to the ANPRM,
several comments suggested that the Agency establish assured
minimum periods of use for substitutes listed as acceptable.
For example, one commenter recommended that the Agency consider
any substitute decision, once made, valid for a minimum of fifteen
years before making any changes. Clearly, there are advantages
to having a guaranteed period within which a substitute can
be used without concern for future changes in the acceptability
of a substitute. In particular, such certainty would encourage
reduced reliance on Class I chemicals in the near term.
Despite this benefit, the Agency believes that providing
time certainty to its decisions on balance could discourage
continued research on substitutes. In addition, the Agency believes
that in certain limited cases, new data on previously approved
or disapproved substitutes may warrant changes to an existing
SNAP determination. Such changes, however, will only be considered
in cases where new information indicates a need to reassess
the risk of a previously evaluated substitute. For example,
new toxicity data may become available that point to a dramatically
different hazard profile for a chemical, and which changes the
risk the substitute poses to human health and the environment
relative to other substitutes. Similarly, if the Agency previously
listed a high-risk substitute as acceptable only because no
other alternative exists for a specific end-use, this determination
may be subject to change if a new substitute with demonstrably
lower overall risks becomes available.
In such instances, which the Agency expects will occur
infrequently,
EPA will provide consideration for companies who earlier made
a switch to a substitute believed to be acceptable. In particular,
the Agency proposes to examine capital expenditures made by
affected industries to manufacture and use a substitute when
it evaluates whether the availability of another alternative
should render the first alternative unacceptable.
d. Implications of Other Regulatory Requirements. The Agency
is proposing that the SNAP program in evaluating substitutes
take into consideration the regulatory requirements of other
environmental and health protection statutes (e.g., the Clean
Water Act or the Occupational Safety and Health Act). By
considering
existing regulatory constraints, the Agency's evaluation of
alternatives will explicitly recognize compliance with provisions
designed to reduce workplace and environmental releases. However,
it will not be possible to factor in regulatory requirements
that are still under development (e.g., more stringent requirements
to control volatile organic compounds and hazardous air pollutants
under Title I and Title III of the CAA). Clearly, in these
instances,
a substitute, although approved, must comply with all future
regulations. Should future regulations severely limit the
availability
of the only substitute for a prohibited substance, EPA would
reconsider the advisability of keeping that substance on the
list of unacceptable substitutes.
Several commenters felt that the goal of section 612 was
to encourage use of substitutes for Class I and Class II chemicals
by relaxing regulatory requirements in other areas. The Agency
does not believe that it was the intent of Congress to use the
authority under section 612 to compromise existing regulatory
requirements. Instead, EPA intends to evaluate substitutes in
the framework of protection provided by current regulatory
standards.
5. EPA-Generated Review of Substitutes
In addition to notices received under section 612 for substitute
review, the Agency is authorized by section 612(c) to add or
delete alternatives to the list of reviewed substitutes on its
own initiative. EPA has many efforts under way to identify and
communicate the availability of promising new alternatives.
These include support for research efforts to study and focus
attention on future substitutes, involvement in the United Nations
Environment Programme biannual assessment of technologies for
key sectors currently using ozone-depleting chemicals, and
technology
transfer projects with industry, other Federal agencies, and
developing nations. Based on information available through these
activities, EPA may initiate review of new substitutes under
section 612. In each case, the next planned quarterly Federal
Register notice updating the status of SNAP determinations will
inform the public that EPA is initiating a review, subject to
the provisions discussed in this proposal. Similarly,
determinations
ultimately reached as a result of these internally-generated
reviews will be publicly noticed every three months.
B. Joint Review of New Substitutes under SNAP and TSCA PMN
1. Applicability
Any potential SNAP submitter who intends to introduce a new
chemical (i.e., a chemical not currently included in the TSCA
inventory) as an alternative for a Class I or Class II chemical
must undergo review not only under section 612, but under section
5 of TSCA (the Premanufacture Notice program) as well. Because
of the overlap in statutory authority, the Agency has established
a joint review process between the SNAP and TSCA Premanufacture
Notice (PMN) programs. This process has been structured to minimize
reporting burden and to ensure consistency in decisions between
the two programs. The following sections describe the joint
review and decision-making process in more detail.
2. Data Submission Requirements and Process
a. SNAP and PMN Forms. The Agency has reviewed the data
submission
needs for the SNAP and PMN programs and found significant overlap.
In general, the Agency has identified only a few additional
data elements beyond those already required by the PMN program
that should be included for review under the SNAP program. These
elements are:
Ozone depletion potential.
Global warming potential.
Explicit quantification of the cost of using the substitute,
including:
-Chemical replacement data
-Chemical cost data
-Incremental equipment expenditures (either new or retrofit)
needed to use substitute
-Information on the cost implications of changes in energy
consumption
(e.g., from the use of a less or more energy-efficient
refrigerant)
Documentation of testing results, where available, regarding
the flammability of substitutes that will be used in consumer
applications.
Given this overlap, the Agency is proposing that a submitter
requesting a review under both the SNAP and PMN programs provide
the above information by following these steps:
Complete the PMN form (EPA Form 7710-25) following the
Instructions Manual currently available through the TSCA Assistance
Information Service.
Indicate on page 11 of the PMN form, "Optional Pollution
Prevention Information," that the chemical to be reviewed is
also to be considered under the SNAP program.
Complete a SNAP addendum that requests information only
on those items listed above. (The addendum can be obtained from
the SNAP Coordinator.)
The completed PMN form (EPA Form 7710-25) will remain the
basis for all information needed to complete review of the new
chemical under section 5 of TSCA. The completed PMN form and
the SNAP addendum together will comprise the data submission
for section 612 review and listing decisions for new chemicals.
This approach is intended to minimize the reporting burden on
submitters.
The Agency will modify the PMN Instructions Manual in the
future to provide more explicit direction on how to complete
the SNAP addendum. A SNAP submitter may also consult the SNAP
Guidance Document, which will be available for potential submitters
at the time the SNAP program is promulgated. Any questions
regarding
the completion of these forms can be directed to either the
PMN pre-notice coordinator or the SNAP Coordinator.
b. Submission of Completed Forms. Both the PMN and SNAP programs
have a review period of 90 days, subject to suspensions and
extensions described in Section VII.A. for the SNAP program
and in the Preamble to the PMN final rule (40 CFR 720.75). To
ensure that new chemical submissions are reviewed and decided
on jointly, the Agency encourages submitters to provide both
the PMN form and SNAP addendum to the PMN and SNAP coordinators.
Failure to provide both programs with the requested information
at the same time could result in delays in the review of a
submitter's
notice seeking approval of a new chemical as a CFC substitute
approved by EPA where it would result in delay of EPA's approval
under the PMN program.
c. Procedures for Handling Confidential Business Information.
The Agency recognizes that, where appropriate, information
submitted
to the PMN and SNAP programs may need to be confidential. EPA
is proposing that all CBI submitted as part of the joint PMN/SNAP
review be maintained and treated in a manner consistent with
TSCA requirements. Confidentiality claims will be processed
and may be reviewed in a manner consistent with 40 CFR part
2, subpart B. This approach is being proposed because the majority
of data provided to SNAP under the joint review process will
come from the PMN form. Submitters should note that while TSCA
and CAA may have different language describing CBI handling
procedures, there is no substantive difference in how CBI is
maintained under the two statutes.
3. Joint Review of New Substitutes Under PMN and SNAP
a. Preparation of Public Docket and Federal Register Notices.
Once the letter of receipt has been issued, the PMN program
will prepare a public docket and Federal Register notice, as
described in the Preamble to the final rule for the PMN program
(40 CFR
720. 75). The PMN program manager will consult with the SNAP
Coordinator in preparing the notice. The Agency is proposing
this approach for joint PMN/SNAP reviews because it believes
it will reduce the reporting burden imposed on manufacturers.
b. Joint Review Process. EPA is proposing to complete joint
evaluations of new chemicals serving as Class I or Class II
substitutes under section 5 of TSCA and section 612 of the CAA.
This joint review process will be coordinated to ensure that
there is consistency in the final decisions made under the PMN
and SNAP programs. To ensure agreement in the decisions, Agency
offices will work in concert to develop toxicity, exposure,
and risk profiles for those substitutes and applications that
come under joint TSCA and CAA review authority. The Agency will
also coordinate its review of the completeness of the information
supplied and subsequent data requests to minimize the reporting
burden on the submitter.
Submitters should note that Agency decisions to restrict
production of particular chemicals under TSCA will, in the case
of joint PMN/SNAP applications, also have the effect of restricting
production of substitutes undergoing review under the SNAP program.
However, companies that produce substitutes only being reviewed
under the SNAP program are not required to cease production
during the SNAP review period.
As part of the review, the PMN and SNAP programs will work
to arrive at a consistent decision regarding the new chemical
under review. Consequently, listing decisions under SNAP will
reference any conditions also incorporated into the PMN review
(e.g., submission of additional toxicity information, restrictions
on use, etc.).
If a substitute meets the conditions for general PMN approval
but not for SNAP approval, the company may produce and market
the substance in question. However, EPA will commence a rulemaking
to prohibit as unacceptable the description or use of the
substitute
as an EPA-approved Class I or II substitute. If the chemical
fails to meet the conditions for PMN approval, the submitter
is barred from producing the chemical and consequently also
from marketing the product as a CFC substitute. Submitters should
note, however, that the CAA section 612 places considerable
emphasis on identifying and promoting the use of substitutes
which, relative to others, reduce overall risks to human health
and the environment. To the extent a substitute offers such
risk reduction, EPA under the CAA will make every effort to
facilitate production and use of that alternative.
c. Communication of Decision. The PMN program will use the
existing TSCA regulatory framework for communicating decisions
to submitters of the decision on the new substitute. The SNAP
program will provide public notice of decisions regarding the
acceptability or unacceptability of a substitute following the
process described in Section VII.A.3.h. EPA will contact the
submitter to determine how best to list the substitute under
the SNAP program if necessary to protect the confidentiality
of the alternative.
C. Joint Review of Substitutes Under SNAP and FIFRA
1. Background on Use of Ozone-Depleting Chemicals in Pesticides
Certain pesticides are formulated with Class I and Class
II chemicals. The most prominent example is the use of methyl
chloroform (1,1,1-trichloroethane) as an inert ingredient.
Pesticide
products that contain Class I and Class II compounds must be
reformulated as these chemicals are phased out of production
under the Clean Air Act. This section describes how the Agency
proposes to handle reviews of these changes.
2. Applicability
Any new pesticide or amendment of an existing formulation
is already subject to Agency approval under current provisions
of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
P.L. 100-460, 100-464 to 100-526, and 100-532. However, as of
the effective date of the SNAP program, new pesticides or
formulation
changes based on Class I or Class II substitutes will also be
subject to review under section 612 of the CAA. These authorities
apply in all cases where a manufacturer amends a pesticide product
to replace chemicals being phased out under section 602. Similarly,
registrations of new pesticide products will also be subject
to SNAP review if the new formula contains chemicals functionally
replacing Class I or II compounds.
3. Review Responsibilities Under FIFRA and CAA/SNAP
In general, review responsibilities for pesticide products
under the CAA SNAP program will focus on a substance's ozone
depletion and global warming potential. The FIFRA reviews will
address factors commonly examined during pesticide amendments
and registrations. The two program offices responsible for these
reviews will coordinate their efforts at critical junctures
and share pertinent data to ensure appropriate technical
consideration
of the substitute.
4. Data Submission Requirements and Process
a. Preparation of Applications. The Agency has reviewed the
data submission needs for the SNAP and FIFRA pesticide
amendment/registration
process and found no significant overlap. Because there is so
little overlap, the Agency is proposing that a submitter requesting
review under both SNAP and the Office of Pesticide Programs'
pesticide amendment/registration process submit all information
ordinarily required for the OPP process as well as a fully
completed
SNAP submission form. A copy of the FIFRA form should be submitted
to the OPP, and a copy of the SNAP form should be submitted
to the SNAP Coordinator. The SNAP form can be obtained from
the SNAP Coordinator. For further guidance, SNAP submitters
may also consult the SNAP Guidance Document, which will be
available
for review at the time the SNAP program is promulgated.
If a registrant is submitting an amendment to a product
registration
under FIFRA that currently contains a Class I or II substance,
he or she should note in Section II ("Amendment Information")
of the FIFRA form that the amendment was prompted by the CAA
production phase-out. Similarly, if a registrant is submitting
an application for a new pesticide registration that would
otherwise
have been based on a Class I or II compound, he or she should
note in Section II of the FIFRA form that the registration includes
a Class I or II substitute.
The submitter should also identify in Section II both the
substitute chemical and the Class I or II compound it is replacing.
Further, if a registrant is aware that a particular chemical
intended for use as a Class I or Class II substitute in a pesticide
formulation has already been approved through earlier SNAP/FIFRA
determinations, the registrant should also reference the relevant
part of the prior review. This additional information will allow
EPA to identify quickly those registrants whose proposed
substitutes
have already been the subject of listing determinations under
SNAP, and thereby streamline the SNAP review.
b. Review of Applications. When the Agency receives the FIFRA
application and SNAP submission, it will log each into the relevant
tracking systems: the Office of Pesticide Program's (OPP) tracking
system for the FIFRA application and the SNAP tracking system
for the SNAP submissions. If the FIFRA application is identified
in Section II as a Clean Air Act substitution, the FIFRA program
coordinator will contact EPA's SNAP coordinator to establish
whether the substitute has been the subject of any prior SNAP
reviews. If the registrant's substitute is on the list of
unacceptable
substitutes, EPA will notify the registrant that the amendment
request cannot be granted. If the registrant's substitute is
on the list of acceptable substitutes, EPA will proceed with
the standard FIFRA application review. If a chemical substitute
is not listed under existing SNAP determinations but is a
substitute
for an ozone depleting compound, EPA will inform the registrant
of the need for a SNAP review.
5. Communication of Decision. Once the EPA review is complete,
the Agency will notify the registrant whether the new formulation
or proposed formulation change is acceptable. At the same time,
the Agency will amend the SNAP determinations to reflect these
findings and will publish the revised determinations in the
next quarterly Federal Register notice. Submitters should note
that, because of the shared authority to review substitutes
under both SNAP and FIFRA, formulators may not sell amended
or new formulations until they have received FIFRA approval.
D. Shared Statutory Authority With the Food and Drug Administration
The Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C.
321, provides for the safety and effectiveness of drugs and
therapeutic devices, the purity and wholesomeness of foods,
and the harmlessness of cosmetics. Under this statute, the Food
and Drug Administration (FDA) regulates the packaging of food
products and incidental additives and requires predistribution
clearance of medical devices.
As defined in the FDCA, medical devices can include any devices,
diagnostic products, drugs, and drug delivery systems. Devices
covered under this jurisdiction are su![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Ozone Layer Depletion - Regulatory Programs
- You are here: EPA Home
- Ozone Layer Depletion
- Regulatory Programs
- 58 FR 28094