EPA final rule sets reporting requirements for 50 chemicals

Washington — The Environmental Protection Agency has issued a final rule that requires anyone who manufactures or imports 50 specified chemicals to report to the agency “certain lists and copies of unpublished health and safety studies” undertaken within the past decade.

This action is being taken, according to EPA, because the Interagency Testing Committee – established under the Toxic Substances Control Act of 1976 – has added the substances to its Priority Testing List. The chemical substances subject to the rule include 20 chemicals EPA has designated as high-priority substances for risk evaluation under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, as well as 30 organohalogen flame retardants the Consumer Product Safety Commission is evaluating for risks under the Federal Hazardous Substances Act of 1960.

Under the rule, published in the June 29 Federal Register and slated to go into effect July 29, manufacturers and importers must submit:

• Lists and copies of unpublished health and safety studies on health effects, such as toxicity studies on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, and endocrine effects
• All unpublished studies on environmental effects, environmental fate and physical chemical properties if performed as described in 40 CFR 716.50
• All unpublished studies on occupational (both users and nonusers), general population, consumer and environmental exposure
• Studies showing any measurable content of the specified chemical in the tested substance, whether single substances or a mixture; the composition and purity of test substances must be reported if included as part of the study

Additionally, the rule is applicable to anyone who intends to manufacture or import the specified chemicals within 90 days of the EPA notice.

The 20 high-priority chemicals are separate from the first 10 chemicals being evaluated for potential health and environmental risks under the Lautenberg Act. The former group of chemicals includes:

• Seven chlorinated solvents
• Six phthalates, or hormone-disrupting substances, linked to several health issues
• Four flame retardants
• Formaldehyde
• One fragrance additive
• One polymer precursor

Requests to withdraw chemical substances from the final rule are due July 13. The requested information is due Sept. 27.