[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR720.78]

[Page 130]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                    Subpart D--Disposition of Notices
 
Sec. 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 Sec. 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 
Sec. 720.36 must retain the following records:
    (i) Copies of, or citations to, information reviewed and evaluated 
under Sec. 720.36(b)(1) to determine the need to make any notification 
of risk.
    (ii) Documentation of the nature and method of notification under 
Sec. 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 Sec. 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 Sec. 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 
Sec. 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]