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U.S. EPA Requires Data on 50 Chemicals Added to TSCA Section 8(d)

Manufacturers and importers must submit certain lists and unpublished health and safety data studies for 50 specified chemicals by Sept. 27, 2021.

US EPA sign on a building

July 20, 2021

By Chelsea Lane, regulatory specialist, UL

On June 29, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule under Section 8(d) of the Toxic Substances Control Act (TSCA) that requires reporting on health and safety data for 50 specified chemicals. This TSCA Health and Safety Data Reporting rule applies to current as well as prospective manufacturers and importers and persons who, in the 10 years preceding the effective date of the final rule, had either proposed to manufacture or import or had manufactured or imported the newly added substances. The final rule is effective July 29, 2021, and the EPA is calling for certain lists and copies of unpublished health and safety studies to be submitted by Sept. 27, 2021. However, some reporting exemptions apply. For details on the reporting requirements, see 40 CFR Part 716 as amended by the final rule.

The purpose of the data collection is to inform EPA’s prioritization activities and risk evaluations under TSCA Section 6 and new chemical reviews under TSCA Section 5. The newly added chemicals consist of 20 designated by the EPA as High-Priority Chemicals currently undergoing risk evaluation and 30 organohalogen flame retardants being evaluated by the Consumer Product Safety Commission (CPSC) for health risks. Information on the 30 organohalogen flame retardants is needed because the CPSC, which is a representative member of the TSCA Interagency Testing Committee (ITC), voted to grant a petition to begin rulemaking for this class of chemicals under the Federal Hazardous Substances Act (FHSA). For a complete list of all 50 chemicals, including their CAS numbers, see the final rule.

Finally, 40 CFR §716.30 provides that data must be submitted to the EPA using the Agency’s Central Data Exchange (CDX) and Chemical Information Submission System (CISS). However, as of this writing, CISS does not include a health and safety data reporting module.

Sources:

Final Rule at 86 Fed. Reg. 34147

40 CFR Part 716

Central Data Exchange

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