Notification of Substantial Risk

Fed. Reg. 11110, Toxic Substances Control Act Statement of Interpretation and Enforcement Policy Notification of Substantial Risk (Mar. 16, 1978) (the 1978 Statement of Interpretation), now largely superseded ... 

TSCA Section 8(e) Notification of Substantial Risk Policy Clarification and Reporting Guidance. 68 Fed. Reg. 33129, 33131 (June 3. 2003) [hereinafter 2003 Reporting Guidance]. 

Any manufacturer, processor, or distributer of a chemical must notify EPA of any infomation demonstrating a substantial risk to human health or the environment. This report, or 8(e) notification, must be made within 15 working days of learning that such information exists. EPA evaluates 8(e) notices and decides upon any action. Industry is also encouraged to submit health and environmental toxicity data on a voluntary, or For Your Information (FYI) basis. 

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. 

As soon as there is sufficient evidence to conclude that a study shows a substantial risk, product stewardship principles come into play. Depending on the procedures in place at each company and the significance of the observed effect, product stewardship could require warnings on product labels and MSDSs, notification to customers and implementing workplace safety precautions. 

Notification or safety alert Communication issued by manufacturer to inform the risk of substantial harm from a medical device. These situations can be of the same importance as class I, class n, or class in recall... 

Herein lies the central paradox of the 1976 law The US EPA must demonstrate that a new chemical substance poses an "unreasonable risk" before it can request specific test data on the substance [37,38]. The point bears repeating A manufacturer or importer does not need to test the toxicity or ecotoxicity of a new chemical substance under the 1976 TSCA, and the US EPA cannot demand testing to obtain those data unless it can demonstrate— without necessarily having any supporting data on which to base that demonstration—that a substance could present a substantial risk due to its toxicity and the likely extent of exposure. After a brief discussion of the exemptions to the notification requirement, we examine how the agency performs that evaluation. 

The EU prescribes the information to be provided in the notification dossier including physical-chemical properties and toxicological and ecological test data. The extent of the data package required depends on the amount of substance placed on the EU market. In the USA there is no specified data set, but the EPA is empowered to demand such testing as is deemed necessary to enable a risk assessment to be made or, under Sec. 5(e) of TSCA, testing may be required if the substance is produced in substantial amounts and there is significant human or environmental exposure. 

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