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    Draft SAB Report Questions EPA’s Downgrading Studies Based on Funding Source and Negative Effects
    The U.S. Environmental Protection Agency convened a Science Advisory Panel to review EPA’s the IRIS Draft Toxicological Review of 15 Trimethylbenzenes. This SAP’s December 22, 2014 draft Report includes the following criticisms of EPA’s Draft Toxicological Review:

    “Some precepts articulated in the Preamble are appear [sic] to the SAB as not consistent with existing EPA 40 guidance or announced policy. This raises questions about whether the agency is changing policy from established guidance and whether such changes have been appropriately vetted, and implemented. Several statements seem to be outside of existing guidance and are provided as examples:

    • p. xxii, line 67 that negative genetic toxicity studies carry less weight than positive ones;

    • p. xxiii, line 78 that funding source can downgrade the credibility of studies;

    • the organ-specific reference values on p. xxx, line 32;

    • and the dismissal of specificity as an aspect of causal analysis on p. xx, line 81.

    The SAB finds that all of these issues are important and should be discussed. However, they should be supported with citations to existing policy or guidance. If these are not existing policy, then they should be flagged as matters under discussion. In view of the incremental alterations that are expected to occur in IRIS assessments over a series of assessment documents, it is important that any changes to the Preamble from assessment to assessment – especially those that could be construed as altered guidance or standards for future data interpretation – be considered carefully and called out for attention in document reviews.”
  • Click here to read Draft SAP report.
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