Reporting and Recordkeeping Under TSCA Section 8(c)
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Overview
Under the Toxic Substances Control Act (TSCA) section 8(c), chemical manufacturers (including importers) and processors must maintain records of significant adverse reactions to health or the environment reported to have been caused by chemical substances or mixtures and, upon request, submit or make the records available to the Agency. Regulations specifying TSCA section 8(c) recordkeeping and reporting requirements are codified at 40 CFR part 717.
Significant adverse reactions are reactions that may indicate a substantial impairment of normal activities or long-lasting or irreversible damage to health or the environment. They include, but are not limited to, long-lasting or irreversible health effects such as cancer or birth defects; partial or complete impairment of bodily functions, such as reproductive disorders, neurological disorders, or blood disorders; impairment of normal activities experienced by all or most of the people exposed at one time or by one person each time he or she is exposed; gradual or sudden changes in the composition of animal life or plant life in an area; abnormal number of deaths of organisms (e.g., fish kills); reduction of the reproductive success or vigor of a species; reduction in agricultural productivity; alterations in the behavior or distribution of a species; and long-lasting or irreversible contamination of components of the physical environment, such as groundwater contamination.
The regulation exempts “known human effects” from this recordkeeping requirement (40 CFR 717.12(b)). The definition of “known human effects” at 40 CFR 717.3(c) covers commonly recognized human health effects resulting from exposure to a substance as described in the scientific literature, material safety data sheets, or product labeling. However, the exemption does not apply if the reaction was a significantly more severe toxic effect than previously described, or if the reaction resulted from a lower exposure level, a significantly shorter exposure period, or a different exposure route than previously described (see 40 CFR 717.3(c)(2)).
To assist respondents in appropriately fulfilling their reporting obligations under this action, EPA has prepared a guidance document that details specific TSCA 8(c) Recordkeeping and Reporting Limitations and Exclusions (pdf) as well as two guidance documents for the submission of records using the Agency’s online Central Data Exchange (CDX) system. These include a Quick Guide to CDX Submissions (pdf) and Guidance on Submitting TSCA section 8(c) Records (pdf) . EPA is also making available, for reference purposes, a historical document entitled Questions and Answers Concerning the TSCA 8(c) Rule (pdf) published by EPA in July of 1984. The agency is not reissuing the historical guidance and notes that it predates multiple amendments to 40 CFR part 717, and therefore, some text may not accurately reflect the current regulations. Among other uses, gathering this type of data before a chemical is prioritized or evaluated could help make the risk evaluation process more efficient.
Reporting on 4,4'-Methylene bis(2-chloroaniline) (MBOCA)
EPA is requiring manufacturers (including importers) and processors of 4,4'-Methylene bis(2-chloroaniline) (CASRN: 101-14-4) (also known as MBOCA) to submit records of significant adverse human health and environmental effects reported to have been caused by this chemical. Records must be submitted within 60 days of publication of this notice in the Federal Register.