Regulations last checked for updates: Oct 18, 2024

Title 40 - Protection of Environment last revised: Oct 16, 2024
§ 791.1 - Scope and authority.

(a) This part establishes procedures and criteria to be used in determining fair amounts of reimbursement for testing costs incurred under section 4(a) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2603(a)).

(b) Section 4(c) of TSCA requires EPA to develop rules for the determination of fair and equitable reimbursement (15 U.S.C. 2603 (c)).

§ 791.2 - Applicability.

(a) This rule is potentially applicable to all manufacturers, importers and processors who may be required by a specific test rule promulgated under section 4(a) of TSCA to conduct tests and submit data, and who seek the assistance of the Administrator in determining the amount or method of reimbursement. Persons subject to a test rule have an obligation from the date the test rule becomes effective until the end of the reimbursement period, either to test or to obtain an exemption and pay reimbursement.

(b) The provisions of this rule will take effect only when private efforts to resolve a dispute have failed and a manufacturer or processor requests EPA's assistance.

§ 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).

authority: 15 U.S.C. 2603 and 2607
source: 48 FR 31791, July 11, 1983, unless otherwise noted.
cite as: 40 CFR 791.3