Subpart G—Significant New Alternatives Policy Program

Source:   59 FR 13147, Mar. 18, 1994, unless otherwise noted. 

§ 82.170   Purpose and scope.

(a) The purpose of these regulations in this subpart is to implement
section 612 of the Clean Air Act, as amended, regarding the safe
alternatives policy on the acceptability of substitutes for
ozone-depleting compounds. This program will henceforth be referred to
as the “Significant New Alternatives Policy” (SNAP) program. The
objectives of this program are to identify substitutes for
ozone-depleting compounds, to evaluate the acceptability of those
substitutes, to promote the use of those substitutes believed to present
lower overall risks to human health and the environment, relative to the
class I and class II compounds being replaced, as well as to other
substitutes for the same end-use, and to prohibit the use of those
substitutes found, based on the same comparisons, to increase overall
risks.

(b) The regulations in this subpart describe persons and substitutes
subject to reporting requirements under the SNAP program and explain
preparation and submission of notices and petitions on substitutes. The
regulations also establish Agency procedures for reviewing and
processing EPA's determinations regarding notices and petitions on
substitutes. Finally, the regulations prohibit the use of alternatives
which EPA has determined may have adverse effects on human health or the
environment where EPA has identified alternatives in particular
industrial use sectors that on an overall basis, reduce risk to human
health and the environment and are currently or potentially available.
EPA will only prohibit substitutes where it has identified other
substitutes for a specific application that are acceptable and are
currently or potentially available.

(c) Notifications, petitions and other materials requested shall be sent
to: SNAP Document Control Officer, U.S. Environmental Protection Agency
(6205–J), 1200 Pennsylvania Ave., NW., Washington, DC 20460.

§ 82.172   Definitions.

Act means the Clean Air Act, as amended, 42 U.S.C. 7401 et seq. 

Agency means the U.S. Environmental Protection Agency.

Application means a specific use within a major industrial sector
end-use.

Class I or class II means the specific ozone-depleting compounds
described in section 602 of the Act.

Decision means any final determination made by the Agency under section
612 of the Act on the acceptability or unacceptability of a substitute
for a class I or II compound.

EPA means the U.S. Environmental Protection Agency.

End-use means processes or classes of specific applications within major
industrial sectors where a substitute is used to replace an
ozone-depleting substance.

Formulator means any person engaged in the preparation or formulation of
a substitute, after chemical manufacture of the substitute or its
components, for distribution or use in commerce.

Health and safety study or study means any study of any effect of a
substitute or its components on health and safety, or the environment or
both, including underlying data and epidemiological studies, studies of
occupational, ambient, and consumer exposure to a substitute,
toxicological, clinical, and ecological, or other studies of a
substitute and its components, and any other pertinent test. Chemical
identity is always part of a health and safety study. Information which
arises as a result of a formal, disciplined study is included in the
definition. Also included is information relating to the effects of a
substitute or its components on health or the environment. Any available
data that bear on the effects of a substitute or its components on
health or the environment would be included. Examples include:

(1) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; data on behavioral disorders; dermatoxicity;
pharmacological effects; mammalian absorption, distribution, metabolism,
and excretion; cumulative, additive, and synergistic effects; acute,
subchronic, and chronic effects; and structure/activity analyses;

(2) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including: Acute
toxicity tests, chronic toxicity tests, critical life stage tests,
behavioral tests, algal growth tests, seed germination tests, microbial
function tests, bioconcentration or bioaccumulation tests, and model
ecosystem (microcosm) studies;

(3) Assessments of human and environmental exposure, including workplace
exposure, and effects of a particular substitute on the environment,
including surveys, tests, and studies of: Biological, photochemical, and
chemical degradation; air, water and soil transport; biomagnification
and bioconcentration; and chemical and physical properties, e.g.,
atmospheric lifetime, boiling point, vapor pressure, evaporation rates
from soil and water, octanol/water partition coefficient, and water
solubility;

(4) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a substitute; and

(5) Any assessments of risk to health or the environment resulting from
the manufacture, processing, distribution in commerce, use, or disposal
of the substitute or its components.

Importer means any person who imports a chemical substitute into the
United States. Importer includes the person primarily liable for the
payment of any duties on the merchandise or an authorized agent acting
on his or her behalf. The term also includes, as appropriate:

(1) The consignee;

(2) The importer of record;

(3) The actual owner; and

(4) The transferee, if the right to draw merchandise in a bonded
warehouse has been transferred.

Major Industrial Use Sector or Sector means an industrial category which
EPA has reviewed under the SNAP program with historically high
consumption patterns of ozone-depleting substances, including:
Refrigeration and air conditioning; foam-blowing; fire suppression and
explosion protection; solvents cleaning; aerosols; sterilants; tobacco
expansion; pesticides; and adhesives, coatings and inks sectors.

Manufacturer means any person engaged in the direct manufacture of a
substitute.

Mixture means any mixture or blend of two or more compounds.

Person includes an individual, corporation, partnership, association,
state, municipality, political subdivision of a state, and any agency,
department, or instrumentality of the United States and any officer,
agent, or employee of such entities.

Pesticide has the meaning contained in the Federal Insecticide,
Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. and the regulations
issued under it.

Potentially available is defined as any alternative for which adequate
health, safety, and environmental data, as required for the SNAP
notification process, exist to make a determination of acceptability,
and which the Agency reasonably believes to be technically feasible,
even if not all testing has yet been completed and the alternative is
not yet produced or sold.

Premanufacture Notice (PMN) Program has the meaning described in 40 CFR
part 720, subpart A promulgated under the Toxic Substances Control Act,
15 U.S.C. 2601 et seq. 

Producer means any person who manufactures, formulates or otherwise
creates a substitute in its final form for distribution or use in
interstate commerce.

Research and development means quantities of a substitute manufactured,
imported, or processed or proposed to be manufactured, imported, or
processed solely for research and development.

Residential use means use by a private individual of a chemical
substance or any product containing the chemical substance in or around
a permanent or temporary household, during recreation, or for any
personal use or enjoyment. Use within a household for commercial or
medical applications is not included in this definition, nor is use in
automobiles, watercraft, or aircraft.

Significant new use means use of a new or existing substitute in a major
industrial use sector as a result of the phaseout of ozone-depleting
compounds.

Small uses means any use of a substitute in a sector other than a major
industrial use sector, or production by any producer for use of a
substitute in a major industrial sector of 10,000 lbs. or less per year.

Substitute or alternative means any chemical, product substitute, or
alternative manufacturing process, whether existing or new, intended for
use as a replacement for a class I or II compound.

Test marketing means the distribution in interstate commerce of a
substitute to no more than a limited, defined number of potential
customers to explore market viability in a competitive situation.
Testing must be restricted to a defined testing period before the
broader distribution of that substitute in interstate commerce.

Use means any use of a substitute for a Class I or Class II
ozone-depleting compound, including but not limited to use in a
manufacturing process or product, in consumption by the end-user, or in
intermediate uses, such as formulation or packaging for other subsequent
uses.

Use restrictions means restrictions on the use of a substitute imposing
either conditions on how the substitute can be used across a sector
end-use or limits on the end-uses or specific applications where it can
be used within a sector.

§ 82.174   Prohibitions.

(a) No person may introduce a new substitute into interstate commerce
before the expiration of 90 days after a notice is initially submitted
to EPA under §82.176(a).

(b) No person may use a substitute which a person knows or has reason to
know was manufactured, processed or imported in violation of the
regulations in this subpart, or knows or has reason to know was
manufactured, processed or imported in violation of any use restriction
in the acceptability determination, after the effective date of any
rulemaking imposing such restrictions.

(c) No person may use a substitute without adhering to any use
restrictions set by the acceptability decision, after the effective date
of any rulemaking imposing such restrictions.

(d) No person may use a substitute after the effective date of any
rulemaking adding such substitute to the list of unacceptable
substitutes.

(e) Rules Stayed for Reconsideration. Notwithstanding any other
provision of this subpart, the effectiveness of subpart G is stayed from
December 8, 1994, to March 8, 1995, only as applied to use of
substitutes for export.

[59 FR 13147, Mar. 18, 1994, as amended at 59 FR 63256, Dec. 8, 1994; 60
FR 3303, Jan. 13, 1995]

§ 82.176   Applicability.

(a) Any producer of a new substitute must submit a notice of intent to
introduce a substitute into interstate commerce 90 days prior to such
introduction. Any producer of an existing substitute already in
interstate commerce must submit a notice as of July 18, 1994, if such
substitute has not already been reviewed and approved by the Agency.

(b) With respect to the following substitutes, producers are exempt from
notification requirements:

(1) Substitutes already listed as acceptable. Producers need not submit
notices on substitutes that are already listed as acceptable under SNAP.

(2) Small sectors. Persons using substitutes in sectors other than the
nine principal sectors reviewed under this program are exempt from the
notification requirements. This exemption shall not be construed to
nullify an unacceptability determination or to allow use of an otherwise
unacceptable substitute.

(3) Small volume use within SNAP sectors. Within the nine principal SNAP
sectors, persons introducing a substitute whose expected volume of use
amounts to less than 10,000 lbs. per year within a SNAP sector are
exempt from notification requirements. This exemption shall not be
construed to allow use of an otherwise unacceptable substitute in any
quantity. Persons taking advantage of this exemption for small uses must
maintain documentation for each substitute describing how the substitute
meets this small use definition. This documentation must include annual
production and sales information by sector.

(4) Research and development. Production of substitutes for the sole
purpose of research and development is exempt from reporting
requirements.

(5) Test marketing. Use of substitutes for the sole purpose of test
marketing is exempt from SNAP notification requirements until 90 days
prior to the introduction of such substitutes for full-scale commercial
sale in interstate commerce. Persons taking advantage of this exemption
are, however, required to notify the Agency in writing that they are
conducting test marketing 30 days prior to the commencement of such
marketing. Notification shall include the name of the substitute, the
volume used in the test marketing, intended sector end-uses, and
expected duration of the test marketing period.

(6) Formulation changes. In cases where replacement of class I or II
compounds causes formulators to change other components in a product,
formulators are exempt from reporting with respect to these auxiliary
formulation changes. However, the SNAP submitter is required to notify
the Agency if such changes are expected to significantly increase the
environmental and human health risk associated with the use of any class
I or class II substitute.

(7) Substitutes used as feedstocks. Producers of substitutes used as
feedstocks which are largely or entirely consumed, transformed or
destroyed in the manufacturing or use process are exempt from reporting
requirements concerning such substitutes.

(c) Use of a substitute in the possession of an end-user as of March 18,
1994, listed as unacceptable or acceptable subject to narrowed use
limits may continue until the individual end-users' existing supply, as
of that date, of the substitute is exhausted. Use of substitutes
purchased after March 18, 1994, is not permitted subsequent to April 18,
1994.

§ 82.178   Information required to be submitted.

(a) Persons whose substitutes are subject to reporting requirements
pursuant to §82.176 must provide the following information:

(1) Name and description of the substitute. The substitute should be
identified by its: Chemical name; trade name(s); identification numbers;
chemical formula; and chemical structure.

(2) Physical and chemical information. The substitute should be
characterized by its key properties including but not limited to:
Molecular weight; physical state; melting point; boiling point; density;
taste and/or odor threshold; solubility; partition coefficients (Log
Kow, Log Koc); atmospheric lifetime and vapor pressure.

(3) Substitute applications. Identification of the applications within
each sector end-use in which the substitutes are likely to be used.

(4) Process description. For each application identified, descriptive
data on processing, including in-place pollution controls.

(5) Ozone depletion potential. The predicted 100-year ozone depletion
potential (ODP) of substitute chemicals. The submitter must also provide
supporting documentation or references.

(6) Global warming impacts. Data on the total global warming potential
of the substitute, including information on the GWP index and the
indirect contributions to global warming caused by the production or use
of the substitute (e.g., changes in energy efficiency). GWP must be
calculated over a 100, 500 and 1000-year integrated time horizon.

(7) Toxicity data. Health and safety studies on the effects of a
substitute, its components, its impurities, and its degradation products
on any organism (e.g., humans, mammals, fish, wildlife, and plants). For
tests on mammals, the Agency requires a minimum submission of the
following tests to characterize substitute risks: A range-finding study
that considers the appropriate exposure pathway for the specific use
(e.g., oral ingestion, inhalation, etc.), and a 90-day subchronic
repeated dose study in an appropriate rodent species. For certain
substitutes, a cardiotoxicity study is also required. Additional
mammalian toxicity tests may be identified based on the substitute and
application in question. To sufficiently characterize aquatic toxicity
concerns, both acute and chronic toxicity data for a variety of species
are required. For this purpose, the Agency requires a minimum data set
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 information and data
summaries, such as the Material Safety Data Sheets (MSDS), should also
be submitted. To assist in locating any studies previously submitted to
EPA and referred to, but not included in a SNAP submission, the
submitter must provide citations for the date, type of submission, and
EPA Office to which they were submitted, to help EPA locate these
quickly.

(8) Environmental fate and transport. Where available, information must
be submitted 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 movement and reaction of substitutes in the environment.

(9) Flammability. Data on the flammability of a substitute chemical or
mixture are required. Specifically, the flash point and flammability
limits are needed, as well as information on the procedures used for
determining the flammability limits. Testing of blends should identify
the compositions for which the blend itself is flammable and include
fractionation data on changes in the composition of the blend during
various leak scenarios. For substitutes that will be used in consumer
applications, documentation of testing results conducted by independent
laboratories should be submitted, where available. If a substitute is
flammable, the submitter must analyze the risk of fire resulting from
the use of such a substitute and assess the effectiveness of measures to
minimize such risk.

(10) Exposure data. Available modeling or monitoring data on exposures
associated with the manufacture, formulation, transport, use and
disposal of a substitute. Descriptive process information for each
substitute application, as described above, will be used to develop
exposure estimates where exposure data are not readily available.
Depending on the application, exposure profiles may 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 on pollutant releases or discharge
to all environmental media. Submitters should provide information on
release locations, and data on the quantities, including volume, of
anticipated waste associated with the use of the substitute. In
addition, information on anticipated waste management practices
associated with the use of the substitute. Any available information on
any pollution controls used or that 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 must also be submitted.

(12) Replacement ratio for a chemical substitute. Information on the
replacement ratio for a chemical substitute versus the class I or II
substances being replaced. The term “replacement ratio” means how
much of a substitute must be used to replace a given quantity of the
class I or II substance being replaced.

(13) Required changes in use technology. Detail on the changes in
technology needed to use the alternative. 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 expenditures) and estimated life
of any technology modifications should also be submitted.

(14) Cost of substitute. Data on the expected average cost of the
alternative. In addition, information is needed on the expected
equipment lifetime for an alternative technology. Other critical cost
considerations should be identified, as appropriate.

(15) Availability of substitute. If the substitute is not currently
available, the timing of availability of a substitute should be
provided.

(16) Anticipated market share. Data on the anticipated near-term and
long-term nationwide substitute sales.

(17) Applicable regulations under other environmental statutes.
Information on whether the substitute is 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, or other titles
under the Clean Air Act.

(18) Information already submitted to the Agency. Information requested
in the SNAP program notice that has been previously submitted to the
Agency as part of past regulatory and information-gathering activities
may be referenced rather than resubmitted. Submitters who cannot provide
accurate references to data sent previously to the Agency should include
all requested information in the SNAP notice.

(19) Information already available in the literature. If any of the data
needed to complete the SNAP program notice are available in the public
literature, complete references for such information should be provided.

(b) The Significant New Alternatives Policy (SNAP) Information Notice is
designed to provide the Agency with the information necessary to reach a
decision on the acceptability of a substitute.

(1) Submitters requesting review under the SNAP program should send the
completed SNAP notice to: SNAP Document Control Officer, U.S.
Environmental Protection Agency (6205–J), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.

(2) Submitters filing jointly under SNAP and the Premanufacture Notice
Program (PMN) should send the SNAP addendum along with the PMN form to:
PMN Document Control Officer, U.S. Environmental Protection Agency
(7407), 1200 Pennsylvania Ave., NW., Washington, DC 20460. Submitters
must also send both documents to the SNAP program, with a reference to
indicate the notice has been furnished to the Agency under the PMN
program. Submitters providing information on new chemicals for joint
review under the TSCA and SNAP programs may be required to supply
additional toxicity data under TSCA section 5.

(3) Submitters filing jointly under SNAP and under the Federal
Insecticide, Fungicide, and Rodenticide Act should send the SNAP form to
the Office of Pesticide Programs, Registration Division, (7505C) 1200
Pennsylvania Ave., NW., Washington, DC 20460, as well as to the SNAP
Document Control Officer.

§ 82.180   Agency review of SNAP submissions.

(a) Processing of SNAP notices —(1) 90–day review process. The
90-day review process will begin once EPA receives a submission and
determines that such submission includes data on the substitute that are
complete and adequate, as described in §82.178. The Agency may suspend
or extend the review period to allow for submission of additional data
needed to complete the review of the notice.

(2) Initial review of notice. The SNAP Document Control Officer 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.). The SNAP Document Control Officer will also review
substantiation of any claim of confidentiality.

(3) Determination of data adequacy. Upon receipt of the SNAP submission,
the Agency will review the completeness of the information supporting
the application. If additional data are needed, the submitter will be
contacted following completion of this review. The 90-day review period
will not commence until EPA has received data it judges adequate to
support analysis of the submission.

(4) Letter of receipt. The SNAP Document Control Officer will send a
letter of receipt to the submitter to confirm the date of notification
and the beginning of EPA's 90-day review period. The SNAP Document
Control Officer will also assign the SNAP notice a tracking number,
which will be identified in the letter of receipt.

(5) 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 10 days
of learning of such data. The submitter must also inform the Agency of
new studies underway, even if the results will not be available within
the 90-day review period. The Agency may contact the submitter to
explore extending or suspending the review period depending on the type
of information received and the stage of review.

(6) Completion of detailed review. Once the initial data review,
described in paragraphs (a)(2) and (3) of this section, has been
completed, the Agency will complete a detailed evaluation of the notice.
If during any time the Agency perceives a lack of information necessary
to reach a SNAP determination, it will contact the submitter and request
the missing data.

(7) Criteria for review. To determine whether a substitute is acceptable
or unacceptable as a replacement for class I or II compounds, the Agency
will evaluate:

(i) Atmospheric effects and related health and environmental impacts;

(ii) General population risks from ambient exposure to compounds with
direct toxicity and to increased ground-level ozone;

(iii) Ecosystem risks;

(iv) Occupational risks;

(v) Consumer risks;

(vi) Flammability; and

(vii) Cost and availability of the substitute.

(8) Communication of decision —(i) Communication of decision to the
submitter. Once the SNAP program review has been completed, the Agency
will notify the submitter in writing of the decision. Sale or
manufacture of new substitutes may commence after the initial 90-day
notification period expires even if the Agency fails to reach a decision
within the 90-day review period or fails to communicate that decision or
the need for additional data to the submitter. Sale or manufacture of
existing substitutes may continue throughout the Agency's 90-day review.

(ii) Communication of decision to the public. The Agency will publish in
theFederal Registerperiodic updates to the list of the acceptable and
unacceptable alternatives that have been reviewed to date. In the case
of substitutes proposed as acceptable with use restrictions, proposed as
unacceptable or proposed for removal from either list, a rulemaking
process will ensue. Upon completion of such rulemaking, EPA will publish
revised lists of substitutes acceptable subject to use conditions or
narrowed use limits and unacceptable substitutes to be incorporated into
the Code of Federal Regulations. (See Appendices to this subpart.)

(b) Types of listing decisions. When reviewing substitutes, the Agency
will list substitutes in one of five categories:

(1) Acceptable. Where the Agency has reviewed a substitute and found no
reason to prohibit its use, it will list the alternative as acceptable
for the end-uses listed in the notice.

(2) Acceptable subject to use conditions. After reviewing a notice, the
Agency may make a determination that a substitute is acceptable only if
conditions of use are met to minimize risks to human health and the
environment. Where users intending to adopt a substitute acceptable
subject to use conditions must make reasonable efforts to ascertain that
other alternatives are not feasible due to safety, performance or
technical reasons, documentation of this assessment must be retained on
file for the purpose of demonstrating compliance. This documentation
shall include descriptions of substitutes examined and rejected,
processes or products in which the substitute is needed, reason for
rejection of other alternatives, e.g., performance, technical or safety
standards. Use of such substitutes in ways that are inconsistent with
such use conditions renders them unacceptable.

(3) Acceptable subject to narrowed use limits. Even though the Agency
can restrict the use of a substitute based on the potential for adverse
effects, it may be necessary to permit a narrowed range of use within a
sector end-use because of the lack of alternatives for specialized
applications. Users intending to adopt a substitute acceptable with
narrowed use limits must ascertain that other alternatives are not
technically feasible. Companies must document the results of their
evaluation, and retain the results on file for the purpose of
demonstrating compliance. This documentation shall include descriptions
of substitutes examined and rejected, processes or products in which the
substitute is needed, reason for rejection of other alternatives, e.g.,
performance, technical or safety standards, and the anticipated date
other substitutes will be available and projected time for switching to
other available substitutes. Use of such substitutes in applications and
end-uses which are not specified as acceptable in the narrowed use limit
renders them unacceptable.

(4) Unacceptable. This designation will apply to substitutes where the
Agency's review indicates that the substitute poses risk of adverse
effects to human health and the environment and that other alternatives
exist that reduce overall risk.

(5) Pending. Submissions for which the Agency has not reached a
determination will be described as pending. For all substitutes in this
category, the Agency will work with the submitter to obtain any missing
information and to determine a schedule for providing the missing
information if the Agency wishes to extend the 90-day review period. EPA
will use the authority under section 114 of the Clean Air Act to gather
this information, if necessary. In some instances, the Agency may also
explore using additional statutory provisions (e.g., section 5 of TSCA)
to collect the needed data.

(c) Joint processing under SNAP and TSCA. The Agency will coordinate
reviews of substitutes submitted for evaluation under both the TSCA PMN
program and the CAA.

(d) Joint processing under SNAP and FIFRA. The Agency will coordinate
reviews of substitutes submitted for evaluation under both FIFRA and the
CAA.

[59 FR 13147, Mar. 18, 1994, as amended at 61 FR 25592, May 22, 1996; 61
FR 54039, Oct. 16, 1996]

§ 82.182   Confidentiality of data.

(a) Clean Air Act provisions. Anyone submitting information must assert
a claim of confidentiality at the time of submission for any data they
wish to have treated as confidential business information (CBI) under 40
CFR part 2, subpart B. Failure to assert a claim of confidentiality at
the time of submission may result in disclosure of the information by
the Agency without further notice to the submitter. The submitter should
also be aware that under section 114(c), emissions data may not be
claimed as confidential.

(b) Substantiation of confidentiality claims. At the time of submission,
EPA requires substantiation of any confidentiality claims made. Failure
to provide any substantiation may result in disclosure of information
without further notice by the Agency. All submissions must include
adequate substantiation in order for an acceptability determination on a
substitute to be published. Moreover, under 40 CFR part 2, subpart B,
there are further instances in which confidentiality assertions may
later be reviewed even when confidentiality claims are initially
received. The submitter will also be contacted as part of such an
evaluation process.

(c) Confidentiality provisions for toxicity data. In the event that
toxicity or health and safety studies are listed as confidential, this
information cannot be maintained as confidential where such data are
also submitted under TSCA or FIFRA, to the extent that confidential
treatment is prohibited under those statutes. However, information
contained in a toxicity study that is not health and safety data and is
not relevant to the effects of a substance on human health and the
environment (e.g., discussion of process information, proprietary
blends) can be maintained as confidential subject to 40 CFR part 2,
subpart B.

(d) Joint submissions under other statutes. Information submitted as
part of a joint submission to either SNAP/TSCA or SNAP/FIFRA must adhere
to the security provisions of the program offices implementing these
statutes. For such submissions, the SNAP handling of such notices will
follow the security provisions under these statutes.

§ 82.184   Petitions.

(a) Who may petition. Any person may petition the Agency to amend
existing listing decisions under the SNAP program, or to add a new
substance to any of the SNAP lists.

(b) Types of petitions. Five types of petitions exist:

(1) Petitions to add a substitute not previously reviewed under the SNAP
program to the acceptable list. This type of petition is comparable to
the 90-day notifications, except that it would generally be initiated by
entities other than the companies that manufacture, formulate, or
otherwise use the substitute. Companies that manufacture, formulate, or
use substitutes that want to have their substitutes added to the
acceptable list should submit information on the substitute under the
90-day review program;

(2) Petitions to add a substitute not previously reviewed under the SNAP
program to the unacceptable list;

(3) Petitions to delete a substitute from the acceptable list and add it
to the unacceptable list or to delete a substitute from the unacceptable
and add it to the acceptable list;

(4) Petitions to add or delete use restrictions on an acceptability
listing.

(5) Petitions to grandfather use of a substitute listed as unacceptable
or acceptable subject to use restrictions.

(c) Content of the petition. The Agency requires that the petitioner
submit information on the type of action requested and the rationale for
the petition. Petitions in paragraphs (b)(1) and (2) of this section
must contain the information described in §82.178, which lists the
items to be submitted in a 90-day notification. For petitions that
request the re-examination of a substitute previously reviewed under the
SNAP program, the submitter must also reference the prior submittal or
existing listing. Petitions to grandfather use of an unacceptable
substitute must describe the applicability of the test to judge the
appropriateness of Agency grandfathering as established by the United
States District Court for the District of Columbia Circuit (see Sierra
Club v. EPA, 719 F.2d 436 (D.C. Cir. 1983)). This test includes 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.

(d) Petition process. (1) Notification of affected companies. If the
petition concerns a substitute previously either approved or restricted
under the SNAP program, the Agency will contact the original submitter
of that substitute.

(2) Review for data adequacy. The Agency will review the petition for
adequacy of data. As with a 90-day notice, the Agency may suspend review
until the petitioner submits the information necessary to evaluate the
petition. To reach a timely decision on substitutes, EPA may use
collection authorities such as those contained in section 114 of the
Clean Air Act as amended, as well as information collection provisions
of other environmental statutes.

(3) Review procedures. To evaluate the petition, the Agency may submit
the petition for review to appropriate experts inside and outside the
Agency.

(4) Timing of determinations. If data are adequate, as described in
§82.180, the Agency will respond to the petition within 90 days of
receiving a complete petition. If the petition is inadequately
supported, the Agency will query the petitioner to fill any data gaps
before the 90-day review period begins, or may deny the petition because
data are inadequate.

(5) Rulemaking procedures. EPA will initiate rulemaking whenever EPA
grants a petition to add a substance to the list of unacceptable
substitutes, remove a substance from any list, or change or create an
acceptable listing by imposing or deleting use conditions or use limits.

(6) Communication of decision. The Agency will inform petitioners within
90 days of receiving a complete petition whether their request has been
granted or denied. If a petition is denied, the Agency will publish in
theFederal Registeran explanation of the determination. If a petition is
granted, the Agency will publish the revised SNAP list incorporating the
final petition decision within 6 months of reaching a determination or
in the next scheduled update, if sooner, provided any required
rulemaking has been completed within the shorter period.

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