TSCA 8 d Health and Safety Data Reporting

TSCA 8(d) requires the EPA to promulgate rules requiring manufacturers, importers, processors, and distributors to submit lists and copies of unpublished health and safety studies on specified chemicals or mixtures. Those studies must be listed or submitted if they were conducted or initiated by or for the manufacturer, importer, processor, or distributor, known to such person, or reasonably ascertainable by such person. The intent of the regulations is to give EPA information to determine the need to issue test rules under TSCA 4, restrictions on use under TSCA 5, or prohibitions on the manufacture, use or distribution pursuant to TSCA 6 on the basis that the chemical substance or mixture presents an umeasonable risk of harm to human health or the environment. 

The obhgations under TSCA 8(d) are not self implementing they are triggered only when the EPA promulgates a rule identifying chemicals and then the regulated industry must Hst or submit studies on those chemicals. 

In this regard the obligation to submit information to the EPA is similar to TSCA 8(a) rules. 

The reporting obHgations of TSCA 8(d) apply to manufacturers, including importers, who fall within the North American Industry Classification System (NAICS) subsector 325 (chemical manufacturing and allied products) or Industry Group 32411 (petroleum refineries) to the extent such manufacturer or importer  

Processors are not otherwise subject to the reporting requirements of TSCA 8(d) unless EPA states specifically that processors should report in a Federal Register notice or rule promulgation.  

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