Allegations of Significant Adverse Reactions to Human Health or the Environment (TSCA Section 8(c)) (Renewal)

TSCA section 8(c) requires companies that manufacture, process, or distribute chemicals to maintain records of significant adverse reactions to health or the environment alleged to have been caused by such chemicals. Since section 8(c) includes no automatic reporting provision, EPA can obtain and use the information contained in company files only by inspecting those files or requiring reporting of records that relate to specific substances of concern. Therefore, under certain conditions, and using the provisions found in 40 CFR part 717, EPA may require companies to report such allegations to the Agency. EPA uses such information on a case-specific basis to corroborate suspected adverse health or environmental effects of chemicals already under review by EPA. The information is also useful to identify trends of adverse effects across the industry that may not be apparent to any one chemical company. This ICR addresses the information reporting and recordkeeping requirements found in 40 CFR part 717.

The latest form for Allegations of Significant Adverse Reactions to Human Health or the Environment (TSCA Section 8(c)) (Renewal) expires 2021-10-31 and can be found here.

Recordkeeping

Federal Enterprise Architecture: Environmental Management - Pollution Prevention and Control