Substantial risk reporting

EPA. 1980b. 8E Substantial risk report Symptoms of all employees who had some contact with exotherm, follow up study of EPA document control no. 8EHQ-0480-0338. Submitted to the U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances, Washington, DC, by the Lockheed Missiles Space Company, Inc. EPA/OPTS 8EHQ-0980-0338. Fiche no. OTS0200599. 

EPA. 1980b. Substantial risk report EPA number 8EHQ-0879-0301. Environmental Protection Agency. Washington DC. 

The Commission has promulgated elaborate and detailed regulatons governing the submission of substantial risk reports. See 16 C.F.R., Part 1115. These regulations also discuss the submission of follow-up information and the negotiation of voluntary corrective action. 

The R D exemption is only an exemption from the PMN, Inventory, and SNUR requirements of TSCA. R D substances are subject to the substantial risk reporting requirements of TSCA 8(e), any restrictions that may be issued under 4 or 6, import certifications, export notifications, and all other TSCA programs. 

The polymer exemption is an exemption from the premanufacture notice requirements and not an exemption from all of the many programs under the Toxic Substances Control Act. An exempt polymer is subject to all of the other TSCA programs, including (but not limited to) the substantial risk reporting in 8(e) of the statute, Significant New Use Rules, import certifications, and export notifications. 

Because the microorganism regulations were issued imder TSCA 5, the Enforcement Response Policy (ERP) for 5 applies to any violation of the microorganism rules governing MCANs and TERAs. Violations of the substantial risk reporting provisions of TSCA and the import and export regulations would be penalized under the ERP for 8, 12 and 13. Similarly, each type of violation would be penalized under the corresponding ERP applicable to traditional chemicals. 

TSCA 8(e) requires the submission of information which reasonably supports the conclusion that [a] substance or mixture presents a substantial risk of injury to health or the environment. The reporting obligation extends to information that does not conclusively demonstrate that a substantial risk exists rather reportable information need merely reasonably support a conclusion of substantial risk. Reporting usually requires judgment calls about whether the information rises to a reportable level. Although the ERA discourages over reporting and file dumps, it is prudent to report in cases of uncertainty because of the consequences that follow from a failure to report. 

Any person who submits CBI to EPA in the context of a substantial risk report will be required to complete a detailed questionnaire in support of the claim of confidentiality. Unlike with many confidentiality claims where substantiation is only required when there is a Freedom of Information Act request, claims of confidentiality for information in 8(e) reports must be submitted with the 8(e) report. ... 

Step 8. The MPC shall also determine if the presence of the subject chemical in the United States will trigger a chemical specific reporting requirement, and if so will gather and submit the required information as required under (insert relevant procedure reference such as the procedure for compliance with TSCA substantial risk reporting. The MRC will update the product database to reflect this information. 

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