Reporting Health and Safety Data Under TSCA section 8(d)
Under TSCA section 8(d), EPA has the authority to promulgate rules to require producers, importers, and (if specified) processors of a chemical substance or mixture to submit lists and/or copies of unpublished (both ongoing and completed) health and safety studies. EPA has also used its TSCA section 8(d) authority to gather information needed by other EPA program offices and other Federal Agencies. Chemicals designated or recommended for testing by the TSCA Interagency Testing Committee (ITC) may be added to the rule via immediate final rulemaking (up to 50 substances/year). Non-ITC chemicals can be added to the TSCA section 8(d) rule via notice and comment rulemaking.
The term "health and safety study" is intended to be interpreted broadly and means "any study of any effect of a chemical substance or mixture on health or the environment or on both," including but not limited to:
Epidemiological or clinical studies;
Studies of occupational exposure;
In vivo and in vitro toxicological studies; and
Ecotoxicological studies.
Rule, Regulations, and Information Received
Additional Resources
- Please refer to this Guide for Using the CDX reporting Application:
And the user guide for the Office of Pollution Prevention and Toxics (OPPT) Section 8(d) Health & Safety Data Reporting application. This document is the user guide for the Primary Support user of the Section 8(d) Health & Safety Data Reporting tool.