Significant Risk Information

The EPA considers itself adequately informed of significant risk information if it has previously received information that a new study merely corroborates. It is important to note that information that is not strictly... 

See, e.g., for precedents on feedback loops in TSCA guidance, the EPA 8(e) Policy, which has the effect of saying that the EPA will not seek penalties from individuals if their employers have compliance procedures requiring feedback to anyone who proposes reporting significant risk information to the EPA. 63 Fed. Reg. 33129,33137 (June 3,2003). 

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. 

People in many job functions may receive potentially reportable significant risk information. Some examples include ... 

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). 

The potential sources of hazards should be listed for risk assessment. SARA requires certain industries to provide information to the planning committee. Information about snuill as well as large industries is necessary to perinit the committee to evaluate tlie significant risks. Tlie information required by SARA (some of which was provided in Cliapter 2) includes ... 

Prediction, as well as analysis, is also important. Conceptually, the difference is clear, but it is seldom properly appreciated. Risk is associated with predictions, but there should not be any significant risk associated with an analysis. To put it rather simply Prediction is about making informed, educated guesses about uncertain, untested events, whereas analysis is about... 

B) A determination of whether adequate information on the health effects of each substance is available or in the process of development to determine levels of exposure that present a significant risk to human health of acute, subacute, and chronic health effects and... 

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