Significant Risk Information under TSCA

The notice of inspection may limit the inspection to one TSCA program. For example, the inspection could be limited to compliance with 8(e) requirements to submit notices of significant risk information, it could be directed to the premanufacture notification requirements of 5, or it could cover all TSCA requirements. The letter will typically specify the kinds of documentation that the inspectors will want to inspect. It is advisable to review these materials in advance to see exactly what the inspector will see, and avoid the element of surprise if there is a violation on the face of a document. It will often be possible to refute any inference of a violation, and all the arguments should be marshaled at this point. For example, if the inspection notice states that all notices of export under 12(b) should be assembled, and a quick review shows that some letters were not submitted until after the export may have taken place, it may be possible to gather documentation showing that the exports occurred later than expected and the notices were indeed timely. 

Notices of Commencement of manufacture or import are an exception, and the substantiation must be submitted with any notice that claims CBI status for information on the form. 40 C.F.R. 720.102(c)(2). For reports of significant risk information submitted under TSCA 8(e), the EPA guidance does not make substantiation mandatory at the time CBI is submitted because it says that the submitter should substantiate any CBI claims. 68 Fed. Reg. 33129, 33140 (June 3, 2002). 

Under the SNUR regulations, the EPA either must make findings that justify issuance of an order under TSCA 5(e), or must determine that new uses may result in significant changes in human exposure or environmental releases, or that there is a concern about the health or environmental effects of the substance. The findings necessary for issuance of a 5(e) consent order are that there is insufficient iifformation to evaluate the effects of the substance on health and the environment The EPA must also find that either (i) without sufficient information to permit an evaluation of the substance s effects on health and the environment there may be an unreasonable risk to health or the environment, or (ii) the substance will be produced in substanticd... 

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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