Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 40 - Protection of Environment |
Chapter I - Environmental Protection Agency |
SubChapter R - Toxic Substances Control Act |
Part 791 - Data Reimbursement |
Subpart A - General Provisions |
§ 791.3 - Definitions.
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§ 791.3 Definitions.
Terms defined in the Act, and not explicitly defined herein, are used with the meanings given in the Act.
(a) The Act refers to the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.).
(b) The Agency or EPA refers to the Environmental Protection Agency.
(c) Byproduct refers to a chemical substance produced without a separate commercial intent during the manufacture, processing, use or disposal of another chemical substance or mixture.
(d) Dispute refers to a present controversy between parties subject to a test rule over the amount or method of reimbursement for the cost of developing health and environmental data on the test chemical.
(e) Exemption holder refers to a manufacturer or processor, subject to a test rule, that has received an exemption under sections 4(c)(1) or 4(c)(2) of TSCA from the requirement to conduct a test and submit data.
(f) Impurity refers to a chemical substance unintentionally present with another chemical substance or mixture.
(g) A party refers to a person subject to a section 4 test rule, who:
(1) Seeks reimbursement from another person under these rules, or
(2) From whom reimbursement is sought under these rules.
(h) Reimbursement period refers to a period that begins when the data from the last non-duplicative test to be completed under a test rule is submitted to EPA and ends after an amount of time equal to that which had been required to develop that data or after 5 years, whichever is later.
(i) Small business refers to a manufacturer or importer whose annual sales, when combined with those of its parent company (if any) are less than $30 million.
(j) Test rule refers to a regulation ordering the development of data on health or environmental effects or chemical fate for a chemical substance or mixture pursuant to TSCA section 4(a).