Substantial risk reporting human health effects

Substantial risk information may be generated in animal and in vitro as well as human studies. Animal or in vitro studies may provide evidence of potential human health effects. Serious risks observed in any test subject are reportable without regard to the extent of potential exposure. As stated hy the Agency in the 1991 Reporting Guide ... 

As discussed in Chapter 7, Reporting and Recordkeeping, 8(e) of the Toxic Substances Control Act (TSCA) requires that any person who imports, manufactures, processes, or distributes chemical substances or mixtures in the United States and who obtains information generated in the United States or in another country that reasonably supports a conclusion that a chemical substance or mixture may present a substantial risk of injury to human health or the environment must immediately report such information to the United States Environmental Protection Agency (EPA), unless the person knows that EPA has already been adequately informed. The information must be submitted to the Agency within thirty calendar days of the individual or business obtaining the information. For information to be reportable under 8(e), it does not need to establish conclusively that a risk exists and does not need to provide evidence that the substance is hazardous to human health or the environment under actual conditions of use and exposure. The information may relate to actual instances of serious human health or environmental injury caused by the chemical or mixture or to observations that are early indications of such effects. Incidents of environmental contamination may also be report-able under TSCA 8(e) and should be reviewed under this procedure in order to determine its immediate reportability as soon as the Company has knowledge of the incident. 

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