Substantial Risk Information
TSCA Section 8(e)
TSCA Section 8(e) is a self-implementing statutory provision that states:
"Any person who manufactures, [(includes imports)] processes or distributes in [U.S.] 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 human 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."
The term "substantial risk" information refers to that information which offers reasonable support for a conclusion that the subject chemical or mixture poses a substantial risk of injury to health or the environment and need not, and typically does not, establish conclusively that a substantial risk exists.
Due to that fact that Section 8(e) was self-implementing and did not, therefore, require formal rulemaking by EPA, the requirement for industry to report "substantial risk" information to EPA began on January 1, 1977, the effective date of TSCA. To facilitate understanding and compliance with the TSCA Section 8(e) reporting requirements, EPA published a "Policy Statement" in the Federal Register on March 16, 1978 (43 FR 11110) and a TSCA Section 8(e) Reporting Guide in June of 1991 (available through the TSCA Hotline).
Clearly, Section 8(e) has the most broad coverage of any of the TSCA Section 8 information reporting provisions in that all chemicals and mixtures subject to TSCA itself are subject to Section 8(e), including those that are by-products, intermediates (enclosed or otherwise), wastes, catalysts, research and development chemicals etc. Further, any company, regardless of its size, market share or assets, that produces, imports, processes, or distributes a TSCA-covered chemical substance or mixture is subject to Section 8(e) should that company obtain reportable "substantial risk" information about that substance or mixture.
In deciding to submit information under TSCA Section 8(e), companies must consider the following:
- The seriousness of the observed effect(s), and
- The fact or probability of the occurrence of the effect(s).
In determining the TSCA Section 8(e)-reportability of information, these two criteria should be weighted differently depending on the seriousness of the observed effect(s) and the extent of the exposure (i.e., the more serious the observed effect(s), the less heavily companies are to weigh actual or potential exposure, and vice versa). For example, where serious toxic effects such as birth defects or cancer are observed, the mere fact that the subject chemical or mixture is in commerce constitutes sufficient evidence of exposure for industry to immediately submit "substantial risk" information to EPA under Section 8(e) of TSCA.
There are several types of information that need not be reported under TSCA Section 8(e). Information need not be reported under Section 8(e) if the information, for example:
- Has been published in the open scientific literature; or
- Has been previously reported to EPA under a mandatory reporting provision of TSCA or other authority administered by EPA; or
- Corroborates (in terms of dose, species, route, exposure time, nature of observed effects) information already known to EPA.
It is important to note that EPA is currently refining its 1978 TSCA Section 8(e) "Policy Statement" and will be issuing further reporting guidance in an upcoming Federal Register notice. The amendments to the 1978 "Policy Statement" include further examples of the types of information not considered reportable under TSCA Section 8(e) (e.g., information about which EPA considers itself to be already adequately informed) and changes to the time frame for Section 8(e) reporting.
EPA considers Section 8(e) of TSCA to be a critically important information gathering tool that serves as an "early warning" mechanism for keeping EPA and other apprised of new-found serious chemical hazards and/or exposures. TSCA Section 8(e) data are extremely valuable input for hazard/risk assessment activities within and outside EPA. Since 1977, EPA has received and reviewed more than 10,000 TSCA Section 8(e) notices covering a wide range of chemical substances and mixtures and containing new data concerning serious adverse health effects, ecotoxicological effects and exposures.