Title 40

SECTION 720.78

720.78 Recordkeeping.

§ 720.78 Recordkeeping.

(a) Any person who submits a notice under this part must retain documentation of information in the notice, including (1) other data, as defined in § 720.50(b), in the submitter's possession or control; and (2) records of production volume for the first three years of production or import, the date of commencement of manufacture or import, and documentation of this information. This information must be retained for five years from the date of commencement of manufacture of import.

(b)(1) Persons who manufacture or import a chemical substance under § 720.36 must retain the following records:

(i) Copies of, or citations to, information reviewed and evaluated under § 720.36(b)(1) to determine the need to make any notification of risk.

(ii) Documentation of the nature and method of notification under § 720.36(c)(1) including copies of any labels or written notices used.

(iii) Documentation of prudent laboratory practices used instead of notification and evaluation under § 720.36(b)(2).

(iv) The names and addresses of any persons other than the manfacturer or importer to whom the substance is distributed, the identity of the substance to the extent known, the amount distributed, and copies of the notifications required under § 720.36(c)(2). These records are not required when substances are distributed as impurities or incorporated into an article, in accordance with paragraph (d) of this section.

(2) A person who manufactures or imports a chemical substance under § 720.36 and who manufactures or imports the substance in quantities greater than 100 kilograms per year must retain records of the identity of the substance to the extent known, the production volume of the substance, and the person's disposition of the substance. The person is not required to maintain records of the disposition of products containing the substance as an impurity or of articles incorporating the substances.

(3) Records under this paragraph must be retained for 5 years after they are developed.

(c) Any person who obtains a test-marketing exemption under this part must retain documentation of information in the application and documentation of compliance with any restrictions imposed by EPA when it granted the application. This information must be retained for five years from the final date of manufacture or import under the exemption.

[48 FR 21742, May 13, 1983; 48 FR 33872, July 26, 1983, as amended at 51 FR 15102, Apr. 22, 1986; 58 FR 34204, June 23, 1993]

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