Source: 59 FR 13147, Mar. 18, 1994, unless otherwise noted.
(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.
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.
(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]
(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.
(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.
(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]
(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.
(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.
| File Type | application/msword |
| File Title | Subpart G—Significant New Alternatives Policy Program |
| Author | oap |
| Last Modified By | Fiffer, Melissa |
| File Modified | 2011-04-28 |
| File Created | 2007-08-17 |