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Pages 3-8

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From page 3...
... Another concern is that some NMDR relationships are found in connection with biologic effects that are not usually evaluated in toxicity tests. If current testing strategies are inadequate to account for NMDR relationships, changes in risk-assessment practices might be necessary.
From page 4...
... conclusions and risk assessment determinations, either qualitatively or quantitatively? Given the important role that the SOTS evaluation could play in making decisions about conventional toxicity testing and risk-assessment practices, EPA asked the National Research Council to evaluate whether it presents a scientifically sound and high-quality analysis of the literature on NMDR curves.
From page 5...
... Important elements of the plan include predefining and documenting the literature-search strategies and their results, establishing criteria for selecting studies for analysis, establishing criteria for determining study quality, using templates for presenting evidence consistently in tabular and graphic form, and documenting approaches to integration of evidence. Guidance on these elements is provided below.
From page 6...
... If such a broad analysis is not feasible in light of the agency's immediate needs, consideration should be given to narrowing the questions and their answers. Methods of Analysis Systematic approaches to evaluating the scientific literature have been recommended by other National Research Council committees and are being developed by government agencies and incorporated into environmental health assessments.
From page 7...
... STATE-OF-THE SCIENCE APPROACH TO ANSWERING QUESTIONS 2 AND 3 EPA's SOTS evaluation concluded that current testing strategies include assays that detect chemicals that interfere with the estrogen, androgen, and thyroid signaling pathways. Assertions were made that the evidence is insufficient to show that NMDR curves for adverse effects occur below particular thresholds -- NOAELs or benchmark doses (BMDs)
From page 8...
... Each of those categories of studies has different goals, so EPA's conclusions about the adequacy of toxicity testing should be rooted in specific reference to and demonstration of its own testing strategies in a systematic manner for the estrogen, androgen, and thyroid pathways. With respect to the question of whether NMDR curves provide information that would alter EPA's current WOE conclusions and risk-assessment determinations, EPA concludes that NMDR curves can have both qualitative and quantitative effects and that current risk-assessment practices will consider the evidence appropriately.

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