40 CFR § 82.178 - Information required to be submitted.

§ 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 ca used 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.