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TSCA Section 8(e) Notices

Toxic Substances
  Control Act

Section 8(e) of the Toxic Substances Control Act (TSCA) - U.S. chemical manufacturers, importers, processors and distributors should notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment. Specifically, Section 8(e) states:

"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 [EPA] Administrator has been adequately informed of such information."

Note that EPA interprets persons who manufacture to also include persons who import such substances into the United States (see definition 7 under Section 2602 of TSCA, referring to 15 USC 2602).

Anyone subject to the TSCA 8(e) reporting requirement should submit a report to EPA within 30 calendar days of obtaining the information. This information may be toxicity or exposure data and need not be complete or definitive. Full reports or summarized results may be submitted.  Limited studies (e.g., range-finding studies), preliminary results and draft reports may constitute sufficient evidence for Section 8(e) reporting. Information that has been published or submitted to EPA under other authorities is exempt from Section 8(e) reporting.  

The Agency routinely asks for additional information from submitters and it posts submissions to make them more easily accessible to the public.

As of September 1, 2006, EPA had received approximately 16,500 8(e) submissions since TSCA 8(e) reporting began in 1977.  This does not include supplemental submissions or follow-up responses to EPA inquires.

Information for making public requests to obtain TSCA 8(e) and FYI submissions is available on the Contact Us page.

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"For Your Information" (FYI) Submissions

The “For Your Information” (FYI) submission classification system was established by EPA to distinguish these voluntary submissions from “substantial risk” notices submitted formally to EPA under Section 8(e), a mandatory reporting provision of TSCA, discussed above.  The FYI classification was created by EPA to capture submissions by persons or organizations not  subject to the reporting requirements.

Since 1977, EPA has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens, academic institutions, state and other federal agencies as well as similar organizations and agencies in foreign countries. These notices contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be pertinent to risk assessment.

Sometimes FYIs are submitted when a manufacturer, importer, or processor is not sure its information supports a conclusion of substantial risk. Often they are submitted when a person or company not required to submit, nevertheless, would like to bring risk information on a chemical to EPA’s attention. Chemical companies, trade associations, public interest groups and academic institutions are among those who submit FYIs.

As of September 1, 2006, EPA had received approximately 1,500  FYI submissions.  This does not include supplemental submissions and follow-up responses to EPA inquires.

Information for making public requests to obtain TSCA 8(e) and FYI submissions is available on the Contact Us page.

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Voluntary Risk Management Actions

EPA's longstanding proactive implementation of Section 8(e) of TSCA has resulted in heightened overall chemical industry awareness of risks posed by exposure to chemical substances and mixtures. This heightened awareness has led, in many cases, to specific voluntary pollution prevention and risk reduction activities designed to directly or indirectly protect health and the environment. It can be argued that EPA's Section 8(e) implementation encourages these voluntary actions to occur earlier than they might otherwise.

Many companies have reported that in direct response to new chemical toxicity or exposure data reported under Section 8(e) or on an FYI basis, the following types of health and/or environmental protection measures have been initiated on a voluntary basis:

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How TSCA 8(e) Information Is Used

TSCA 8(e) data can be used by all levels of government, public interest groups, the chemical industry, the public and other stakeholders to further assess and understand potential human health and environmental risks associated with exposure to chemical substances. Understanding potential risks associated with chemicals is an important component of risk management actions by regulation or by voluntary compliance to reduce risks.

Information for making public requests to obtain 8(e) and FYI submissions is available on the Contact Us page.

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Public Access to TSCA 8(e) and FYI

TSCA 8(e) notices most often contain toxicity data but they may also provide information on exposure, environmental persistence or actions being taken to reduce human health and environmental risks.  Summarized results or full studies assessing acute effects, reproductive and developmental toxicity, carcinogenicity, neurotoxicity, genetic effects are made available to the public as well as epidemiological  studies, clinical studies, ecological studies and information on fish another aquatic species.

Copies of TSCA 8(e) and FYI submissions are available to the public in the TSCA Public Docket at EPA Headquarters where paper or microfiche copies of all TSCA 8(e) and FYI submissions are maintained and can be accessed by visiting the public reading room at EPA Headquarters or by contacting EPA using the information located on the contact us page. New submissions may be available and accessed directly from the biweekly or monthly tabular summaries located on the 8(e) and FYI submissions.

TSCA 8(e) and FYI submissions are also available through the National Technical Information Service (NTIS) of the U.S. Department of Commerce. Telephone: (703) 605-6000.

Information on TSCA 8(e) and FYI submissions, but not the submissions themselves, is available from the Toxic Substances Control Act Test Submission (TSCATS) database.

The TSCATS database is also available at the following websites:

The National Library of Medicine's TOXLINE database,
select "TOXLINE" database, then "Limits", then "TSCATS" under TOXLINE Components.

Syracuse Research Corporation's websiteExit EPA Disclaimer,
then select TSCATS.

The Right-to-Know Network's websiteExit EPA Disclaimer

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