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 implementsection 612 of the Clean Air Act, as amended, regarding the safe alternatives policy on the acceptability of substitutes for ozonedepleting compounds. This program will henceforth be referred toas the “Significant New Alternatives Policy” (SNAP) program. The objectivesof this program are to identify substitutes for ozone-depleting compounds, toevaluate the acceptability of those s ubstitutes, to promote the use of those substitutes believed to present lower ov erall 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 explai n preparation and subm ission of notices and petitions on substitutes. The regulations also establish A gency procedures for reviewing and processing EPA's determinations regarding notices and pet itions on substitutes. Finally, the regulations prohibit the use of alternatives which EPA has det ermined may have adverse effects on human health or the environment wh ere 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 substitu tes where it has identifi ed other substitutes for a specific application that are acceptable and are current ly or potentially available. (c) Notifications, petitions and other materials r equested shall be sent to : SNAP Document Control Officer, U.S. Environmental Protection Agency (6205–J), 1200 P ennsylvania 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. Environm ental Protection Agency. Application means a specific use within a major industrial sector end-use.

Class I or class II means the specific ozone-de pleting compounds descri bed 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 subs titute for a class I or II compound.

EPA means the U.S. Environm ental Protection Agency.

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

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

### 2 Health and safety study or study means any study of any effect ofa substitute or its components on health and safety, or the environment or both, in cluding underlying data and epidemiological studies, studies of occupational, ambient, and consumer exposure to a substitu te, toxicological, clinical, and ecological, or other studies ofa substitute and its component s, and any other pertinent test. Chemical identity is always part of a health and safe ty study. Information which arises as a result of a formal, disciplined study is included in the definit ion. Also included is information relating to the effects of a substitute or it s 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, di stribution, metabolism, and excretion; cumulative, additive, and synergistic e ffects; acute, subchroni c, and chronic effects; and structure/acti vity analyses; (2) Tests for ecological or other environmental e ffects on invertebrates, fish, or other animals, and plants, including: Acute toxicity te sts, chronic toxicity te sts, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, microbial function test s, bioconcentration or bioaccumulation tests, and model ecosystem (micro cosm) studies; (3) Assessments of human and environmental expo sure, including workplace exposure, and effects of a particular substitute on the environment, incl uding surveys, tests, and studies of: Biological, photochemical, and chemic al 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 wate r, 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 environ ment resulting from the manufacture, processing, distribution in commerce, use, or dispos al 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 pay ment of any duties on the merchandise or an authorized agent acting on his or her behalf. T he 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 me rchandise 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 cons umption patterns of oz one-depleting substances, including: Refrigeration and ai r conditioning; foam-blowing; fire suppression and explosion protection; solvents cleaning; aeros ols; sterilants; tobacco expa nsion; pesticides; and adhesives, coatings and inks sectors.

### 3 Manufacturer means any person engaged in the dire ct manufacture of a substitute.

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

Person includes an individual, corporation, partnership, association, state, m unicipality, political subdivision of a state, and any age ncy, department, or instrumentality of the United States and any officer, agent, or employ ee of such entities.

Pesticide has the meaning contained in t he Federal Insecticide, Fungi cide, and Rodenticide Act, 7 U.S.C. 136 et seq. and the regulations issued under it. Potentially available is defined as any alternative fo r which adequate health, safety, and environmental data, as required for the SNAP notificat ion process, exist to make a determination of acceptability, and which t he Agency reasonably believes to be tec hnically feasible, even if not all testing has yet been completed and the alte rnative 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 Subst ances 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 manuf actured, 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 c hemical substance or any product containing the chemical subst ance in or around a permanent or temporary household, during recreation, or for any personal use or enjoyment. Use within a househol d 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 substitutein 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 ot her than a major industrial use sector, or production by any producer for use ofa substitute in a major industri al sector of 10,000 lbs. or less per year. Substitute or alternative means any chemical, product substitu te, 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 comme rce of a substitute to no more than a limited, defined number of potential cu stomers to explore market viability in a competitive situation. Testing must be restricted to a defined testing period before the broader distribut ion of that substitute in interstate commerce.

Use means any use of a substitute for a Class I or Class II ozone-depleti ng 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 othersubsequent uses.

### 4 Use restrictions means restrictions on the us e 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 in to 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 pers on 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 im ported 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 rest rictions set by the acceptability decision, after the effectiv e date of any rulemaking im posing such restrictions. (d) No person may use a substitute after the effe ctive 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 stay ed from December 8, 1994, to Ma rch 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 substitu te must submit a notice of intentto introduce a substitute into interstate commerce 90 days prior to such introduction. Any produc er of an existing substitute already in interstate commerce must submit a notic e 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 not ification requirements: (1) Substitutes already listed as acceptable. Producers need not submit not ices 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 unacceptab ility 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 ofuse amounts to less than 10,000 lbs. per year within a SNAP sector are exempt from notificat ion 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 mu st maintain documentati on for each substitute describing how the substitute meets this small use definition. This doc umentation must include annual production and sales information by sector.

### 5 (4) Research and development. Production of substitutes for t he sole purpose of research and development is exempt from reporting requirements. (5) Test marketing. Use of substitutes for the sole purpose oftest marketing is exempt from SNAP notification requirements until 90 day s prior to the introduction of su ch substitutes for full-scale commercial sale in inters tate commerce. Persons taking advant age 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, in tended 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 formulatio n changes. However, the SNAP submitter is required to not ify 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 oruse process are exempt from reporting requirements conc erning such substitutes. (c) Use of a substitute in the possession of an end-user as of Marc h 18, 1994, listed as unacceptable or acceptable subject to narrowed use limits may c ontinue until the individual endusers' existing supply, as of that date, of the s ubstitute is exhausted. Us e of substitutes purchased after March 18, 1994, is not permi tted 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 ident ified by its: Chemical name; trade name(s); identification numbers; c hemical formula; and c hemical structure. (2) Physical and chemical information. The substitute should be characterized by its key properties including but not limited to: Molecular weight; physi cal state; melting point; boiling point; density; taste and/or odor threshold; solub ility; partition coefficients (Log K ow , Log K oc ); atmospheric lifetime and vapor pressure. (3) Substitute applications. Identification of the applic ations within each sect or end-use in which the substitutes are likely to be used. (4) Process description. For each application identified, descrip tive data on processing, including inplace pollution controls. (5) Ozone depletion potential. The predicted 100-year ozone depleti on potential (ODP) of substitute chemicals. The submitter must also prov ide supporting documentat ion or references. (6) Global warming impacts. Data on the total global warming pot ential of the substitute, including information on the GWP index and the indirect contributions to global warming caused by the

### 6 production or use of the substitute (e.g., changesin 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 or ganism (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 consi ders 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 cardio toxicity study is also required. Additional mammalian toxicity tests may be iden tified based on the substi tute and application in question. To sufficiently characteri ze aquatic toxicity concerns, bot h 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 Nati onal Water Quality Criteria for the Protection of Aquatic Organisms and their Uses,” which is ava ilable through the National Technical Information Service (#PB 85–227049). Other relevant informat ion 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, informati on must be submitted on the environmental fate and transport of substitute s. Such data shall include information on bioaccumulation, biodegradation, adsor ption, volatility, transformati on, and other data necessary to characterize movement and reaction of substitutes in the environment. (9) Flammability. Data on the flammability of a substitutechemical or mixture are required. Specifically, the flash point and flammability limits are needed, as well as information on the procedures used for determining t he flammability limits. Testing of blends should identify the compositions for which the blend itself is fla mmable and include fractionat ion data on changes in the composition of the blend during vari ous leak scenarios. For substitute s that will be used in consumer applications, documentation of test ing results conducted by independent laboratories should be submitted, where available. If a s ubstitute 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 dat a on exposures associated with the manufacture, formulation, trans port, use and disposal of a subs titute. Descriptive process information for each substitute application, as descr ibed above, will be us ed to develop exposure estimates where exposure data are not readily avai lable. Depending on the application, exposure profiles may be needed for workers, c onsumers, 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 m edia. Submitters should provide information on release locations , and data on the quantities, includi ng volume, of anticipated waste associated with the use of the substitute. In addition, information on ant icipated waste management practices associated with the us e of the substitute. Any avail able information on any pollution controls used or that could be used in association with the subs titute (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 replacem ent ratio for a chemical substitute versus the class I orII substances being replaced. Th e term “replacement ratio” means

### 7 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 descr iption of whether the substitute can be used in existing equipment—with or without some retrof it—or only in new equipment. Data on the cost (capital and operating expenditures) and estimated life of any technol ogy modifications should also be submitted. (14) Cost of substitute. Data on the expected average cost of th e alternative. In addition, information is needed on the expected equipment lifetime for an alternative te chnology. Other critical cost considerations should be i dentified, as appropriate. (15) Availability of substitute. If the substitute is not currently ava ilable, the timing of availability of a substitute should be provided. (16) Anticipated market share. Data on the anticipated near-t erm and long-term nationwide substitute sales. (17) Applicable regulations under ot her environmental statutes. Information on whether the substitute is regulated under ot her statutory authorities, in parti cular the Clean Water Act, Safe Drinking Water Act, the Resource Conservation and Recovery Act, the Federal Insecticide, Fungicide, and Rodenticide Act, the Toxic S ubstances Control Act, the Comprehensive Environmental Response, Com pensation and Liability Act, the Em ergency 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 s ubmitted to the Agency as part ofpast regulatory and informationgathering activities may be referenced rather t han resubmitted. Submitte rs who cannot provide accurate references to data sent previously to the Agency should in clude 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 Alternativ es Policy (SNAP) Information No tice is designed to provide the Agency with the information nece ssary to reach a decision on the acceptability of a substitute. (1) Submitters requesting review under the SN AP program should send t he completed SNAP notice to: SNAP Document Control Officer, U.S. Environmental Protecti on 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 Pe nnsylvania 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. Subm itters providing information on new chemicals for joint review under the TS CA and SNAP programs may be required to supply additional toxicity data under TSCA section 5.

### 8 (3) Submitters filing jointly under SNAP and unde r the Federal Insecticide, Fungicide, and Rodenticide Act should s end the SNAP form to the Office ofPesticide 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 ofadditional data needed to complete the review of the notice. (2) Initial review of notice. The SNAP Document Control Officer w ill review the notice to ensure that basic information necessary to process the submission is present (i.e., name of company, identification of substitu te, etc.). The SNAP Document Control O fficer will also review substantiation of any claim of confidentiality. (3) Determination of data adequacy. Upon receipt of the SNAP subm ission, the Agency will review the completeness of the informat ion 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 a dequate to support analysi s of the submission. (4) Letter of receipt. The SNAP Document Control Officer will s end a letter of receipt to the submitter to confirm the date of notific ation 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 informat ion during review period. If critical new informat ion becomes available during the review period that may influence the Agency's evaluation of a substitute, the submitter must notify the Agency aboutthe existence of such information within 10 days of learning of such data. The submitter must also in form the Agency of new studies unde rway, even if the results will not be available within the 90-day review period. The Agency may contact t he 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 comp leted, the Agency will complete a detailed evaluation of the notice. If during any time the Agency perceives a lackof information necessary to reach a SNAP determination, it will contact the s ubmitter 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 co mpounds, the Agency will evaluate: (i) Atmospheric effects and relat ed health and environmental impacts; (ii) General population risks from ambient expos ure to compounds with direct toxicity and to increased ground-level ozone; (iii) Ecosystem risks;

### 9 (iv) Occupational risks; (v) Consumer risks; (vi) Flammability; and (vii) Cost and availability of the substitute. (8) Communication of decision —(i) Communication of decisi on to the submitter. Once the SNAP program review has been completed, the Agency will notify the submitte r in writing of the decision. Sale or manufacture of new substitutes may co mmence 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 subm itter. Sale or manufacture of existing substitutes may continue th roughout the Agency's 90-day review. (ii) Communication of decision to the public. The Agency will publish in t heFederal Registerperiodic updates to the list of the accept able 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 rulemaki ng 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 tobe incorporated into the Code of Federal Regulations. (See Appendices to this subpart.) (b) Types of listing decisions. When reviewing substitutes, the A gency 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 acceptabl e for the end-uses lis ted 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 us e are met to minimize risks to human health and the environment. Where users int ending to adopt a substitu te acceptable subject to use conditions must make reasonable efforts to a scertain that other alter natives are not feasible due to safety, performance or technical reasons, docum entation of this assessment must be retained on file for the purpose of demonstrating compliance. This documentat ion shall include descriptions of substitutes examined and rejected, processes or pr oducts in which the subs titute is needed, reason for rejection of other alternativ es, e.g., performance, technical orsafety standards. Use of such substitutes in ways that are inconsistent with such use c onditions renders them unacceptable. (3) Acceptable subject to narrowed use limits. Even though the Agency can re strict the use of a substitute based on the potential for adverse effe cts, it may be necessary to permit a narrowed range of use within a sector end-us e because of the lack of alternat ives for specializ ed applications. Users intending to adopt a substituteacceptable with narrowed use lim its must ascertain that other alternatives are not technically feasible. Companiesmust document the result s 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 reje ction of other alternatives, e.g., performance, technical or safety standards, and the anticipat ed date other substitutes will be av ailable and projected time for switching to other available subs titutes. Use of such substitute s in applications and end-uses which are not specified as accept able in the narrowed use limitrenders them unacceptable.

### 10 (4) Unacceptable. This designation will apply to substitutes w here 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 notreached a determination will be described as pending. For all substitutes in th is category, the Agency will work with the submitter to obtain any missing information and to determine a schedule for pr oviding the missing information if the Agency wishes to extend the 90- day review period. EPA will use the authority under sect ion 114 of the Clean Air Act to gather this informati on, if necessary. In some instanc es, the Agency may also explore using additional statutory provisions (e.g., se ction 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 as sert a claim of confidentiality at the time of submission for any data they wish tohave treated as confident ial business information (CBI) under 40 CFR part 2, subpart B. Failure to asse rt a claim of confident iality at the time of submission may result in disclosure of the inform ation by the Agency withoutfurther 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 subst antiation may result in disclosure of information without further not ice by the Agency. All subm issions must include adequate substantiation in order for an a cceptability determination on a substitute to be published. Moreover, under 40 CFR part 2, subpart B, there are further in stances in which confi dentiality assertions may later be reviewed even when confident iality claims are initially rece ived. 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 maintai ned as confidential where such data are also submitted under TSCA or FIFRA, to the exte nt that confidential treat ment is prohibited under those statutes. However, informat ion contained in a toxicity study that is not health and safety data and is not relevant to the effects of a subs tance on human health and the environment (e.g., discussion of process information, proprietary bl ends) 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 t he security provisions of the program offices implementing these statutes. For such submissions, the SNAP handli ng of such notices will follow the security provisions under these statutes.

### 11 § 82.184 Petitions. (a) Who may petition. Any person may petition t he Agency to amend existi ng listing decisions under the SNAP program, or to add a new s ubstance 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 com parable to the 90-day notifications, except that it would generally be initiated by entities other than the companies t hat manufacture, formulate, or otherwise use the substitute. Companies thatmanufacture, formulate, or use s ubstitutes that want to have their substitutes added to the acceptabl e list should submit in formation on the substitute under the 90-day review program; (2) Petitions to add a substitute not previ ously reviewed under the SNAP program to the unacceptable list; (3) Petitions to delete a substitute from the a cceptable list and add it to t he unacceptable list or to delete a substitute from the unacceptabl e and add it to the acceptable list; (4) Petitions to add or delete use re strictions on an a cceptability listing. (5) Petitions to grandfather use ofa substitute listed as unaccept able or acceptable subject to use restrictions. (c) Content of the petition. The Agency requires that the petitioner submit in formation 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 informat ion described in §82.178, which lists the items to be submitted in a 90-day notification. For pet itions that request the re-examination of a substitute previously reviewed under the SNAP program, the submitter must also re ference the prior submittal or existing listing. Petitions to grandfather use of an unacceptable substitute must descr ibe the applicability of the test to judge the appropriateness of Agency grandfatheri ng 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 represen ts 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 concer ns 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 t he petition for adequacy of data. As with a 90-day notice, the Agency may su spend review until the petitio ner 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 provisio ns 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.

### 12 (4) Timing of determinations. If data are adequate, as described in §82.180, the A gency will respond to the petition within 90 days of receiving a co mplete petition. If t he 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 petiti on because data are inadequate. (5) Rulemaking procedures. EPA will initiate rulemaking whe never EPA grants a petition to add a substance to the list of unaccept able substitutes, remove a subs tance from any list, or change or create an acceptable listing byimposing 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 R egisteran explanation of the det ermination. If a petition is granted, the Agency will publish the re vised SNAP list incorporating t he final petition decision within 6 months of reaching a determi nation or in the next scheduled update, if sooner, provided any required rulemaking has been complet ed within the shorter period.