40 CFR 82.172 - Definitions.

§ 82.172 Definitions.

Act means the Clean Air Act, as amended, 42 U.S.C. 7401et 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. 136et 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. 2601et 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.