Using TSCA Section 8(e)
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Section 8(e) of the Toxic Substances Control Act (TSCA) states that, "Any person who manufactures, processes or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information."
OPPT screens all TSCA §8(e) submissions, as well as voluntary "For Your Information" (FYI) submissions. The latter are not required by law, but are submitted by industry and public interest groups for a variety of reasons. The purpose of EPA’s review is to:
- Identify chemicals for further assessment or testing
- Refer information of interest to other regulatory authorities and stakeholders
- Follow-up with submitters regarding risk management actions
- Provide chemical hazard and exposure information to the Agency and public to aid in risk assessment and risk management of commercial chemicals
- Estimate the effects of closely related chemicals
- Promote pollution prevention through improved understanding of comparative toxicities
Information from the summaries can also be instrumental in avoiding unnecessary testing.
TSCA §8(e) and FYI submissions are entered into the TSCA Test Submissions (TSCATS) database, a submission and document tracking system. EPA continues to provide TSCATS information to the National Library of Medicine for inclusion in the Toxline database and to others to maintain various databases. New TSCA §8(e) submissions are available to the public through EPA's TSCA §8(e) Web page.
- More than 500 initial and more than 170 supplemental TSCA §8(e) submissions were received from January 2007 through June 2008.
- A review of several hundred studies was completed in 2007 in response to a request by the Office of Enforcement to evaluate studies for possible violations of TSCA Section 8(e).
- Seventy-two voluntary FYI submissions were received and their initial screening evaluations are in progress.
- Of the more than 301 TSCA §8(e) information referrals sent from January 2007 through June 2008, 117 related primarily to EPA PFOA program activities.
- Also during 2007, OPPT continued to develop its database to improve file management and the review of new submissions.