• TSCA section 8(c) requires that allegations of adverse reactions caused by any chemical substance or mixture to the health of employees be kept for 30 years, and all other allegations be kept for five years.
• Respondents subject to 40 CFR 717 must submit copies of allegation records when required by the EPA.
• Firms subject to 40 CFR 717 must keep their TSCA section 8(c) records at company headquarters or at a site central to their chemical operations.

Toxic Substances Control Act (TSCA) section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years.

The Environmental Protection Agency (EPA) promulgated 40 CFR 717, on August 22, 1983. The regulation requires manufacturers (including importers) and processors of chemical substances and mixtures to keep records of “significant adverse reactions” alleged to have been caused by such substances or mixtures. The rule also prescribes the conditions under which a firm must submit or make records available to a duly designated representative of EPA.

Required records

Records maintained pursuant to 40 CFR 717 must consist of the following:

• The original allegation as received.
• An abstract of the allegation and other pertinent information as follows:
  • The name and address of the plant site that received the allegation.
  • The date the allegation was received at that site.
  • The implicated substance, mixture, article, company process or operation, or site discharge.
  • A description of the alleger (e.g., employee or neighbor), including age and sex, if ascertainable.
  • A description of the health effects, including explanation of how the effects became known and the route of exposure, if explained in the allegation.
• The results of any self-initiated investigation with respect to an allegation. (EPA does not require such investigation under TSCA section 8(c).)
• Copies of any further required records relating to the allegation, e.g., records required under the Occupational Safety and Health Administration (OSHA).

Required compliance activities

Respondents subject to 40 CFR 717 must:

• Maintain records of allegations of significant adverse reactions — Entities subject to the rule must record significant reactions alleged to have been caused by substances or mixtures that they manufacture, import, or process. These firms must establish a recordkeeping system for such allegations and monitor incoming complaints to determine if they meet the criteria for filing. Allegations that are filed must be retained for 30 years if they are employee-related and for five years for all other types/sources of allegations.
• Submit copies of these allegation records when required by EPA — EPA will notify those responsible for reporting by letter or will announce any such requirements by notice in the Federal Register. When required to report, firms must submit copies of records via CDX https://cdx.epa.gov/ using the EPA-provided electronic reporting application.

Claims of confidentiality must be made in accordance with the procedures described in 40 CFR 703.

Firms subject to 40 CFR 717 must:

• Keep their TSCA section 8(c) records at company headquarters or at a site central to their chemical operations — A multi-site company will usually require the responsible official at the individual plant site to forward potentially recordable TSCA section 8(c) allegations to a designated TSCA coordinator at their operations headquarters. Depending on the size of the company, such allegations will be reviewed by a committee to determine if the allegations relate to the company’s product, operations, or discharges. If so, the effects cited in the allegation are compared against the rule’s definition and examples of “significant adverse reaction.” If the allegation meets this test, it is recorded. The actual allegation record is to be comprised of an abstract of the allegation along with a record of any company-initiated investigation and other pertinent documents. The rule does not require further investigation. EPA requires that allegations be filed so that they may be readily retrievable by the alleged “cause” of the reaction. EPA does not, however, require a specific form under this rule.
• Maintain an awareness of their reporting requirements — A reporting requirement will take the form of a letter directed to selected respondents or it will be a notice in the Federal Register. Respondents are responsible for monitoring the Federal Register for such notices. Whenever feasible, EPA will also notify those companies that can be identified with the production, importation, or processing of a substance or mixture in question. Respondents then must determine if they manufacture or process the chemical substance or mixture. If so, they must conduct a search of their TSCA section 8(c) files to determine if there are any relevant records of significant adverse reactions alleged to have been caused by the substance or mixture. When required to report, firms must submit copies of records via CDX https://cdx.epa.gov/ using the EPA-provided electronic reporting application. The firm should note that it has submitted such records to EPA so that future duplicative reporting will not occur.