(a) Establishment and location of records. A firm subject to this part shall establish and maintain records of significant adverse reactions alleged to have been caused by chemical substances or mixtures manufactured or processed by the firm. Such records shall be kept at the firm's headquarters or at any other appropriate location central to the firm's chemical operations.

(b) Content of records. The record shall consist of the following:

(1) The original allegation as received.

(2) An abstract of the allegation and other pertinent information as follows:

(i) The name and address of the plant site which received the allegation.

(ii) The date the allegation was received at that site.

(iii) The implicated substance, mixture, article, company process or operation, or site discharge.

(iv) A description of the alleger (e.g., “company employee,” “individual consumer,” “plant neighbor”). If the allegation involves a health effect, the sex and year of birth of the individual should be recorded, if ascertainable.

(v) A description of the alleged health effect(s). The description must relate how the effect(s) became known and the route of exposure, if explained in the allegation.

(vi) A description of the nature of the alleged environmental effect(s), identifying the affected plant and/or animal species, or contaminated portion of the physical environment.

(3) The results of any self-initiated investigation with respect to an allegation. (EPA does not require persons subject to this part to investigate allegations received, and no provision of this part shall be construed to imply that EPA recommends, encourages or requires such investigation.)

(4) Copies of any further required records or reports relating to the allegation. For example, if an employee allegation results in a requirement for the firm to record the case on Occupational Safety and Health Form 101 or appropriate substitute (see 29 CFR part 1904 for requirements under the Occupational Safety and Health Act of 1970), a copy of that OSHA record must be included in the allegation record.

(c) File structure. Records must be retrievable by the alleged cause of the significant adverse reaction, which cause may be one of the following:

(1) A specific chemical identity.

(2) A mixture.

(3) An article.

(4) A company process or operation.

(5) A site emission, effluent or other discharge.

(d) Retention period. Records of significant adverse reactions to the health of employees shall be retained for a period of 30 years from the date such reactions were first reported to or known by the person maintaining such records. This provision requires persons subject to this part to retain for 30 years an employee health related allegation, arising from any employment related exposure, whether or not such allegation was submitted by or on the behalf of that recordkeeper's own employee. Any other record of significant adverse reactions shall be maintained for a period of five years from the date the information contained in the record was first reported to or known by the person maintaining the record.

(e) Transfer of records.

(1) If a firm ceases to do business, the successor must receive and keep all the records that must be kept under this part.

(2) If a firm ceases to do business and there is no successor to receive and keep the records for the prescribed period, these records must be transmitted to EPA. See §717.17(c) for the address to which such records must be sent.

[48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993]