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®: CRE Regulatory Action of the Week

CRE Advises FDA of Information Quality Requirements for its Bisphenol A Peer Review
In an October 15 letter and white paper to FDA, CRE pointed out several IQA requirements for the current BPA peer review that would prevent FDA from certifying compliance with the IQA peer review guidance, as it must.

CRE explains that the written charge to the peer reviewers does not, as required, instruct them against embedding conservatism or "precautionary" policy bias in their review, as urged by several commenters. In addition, there is nothing on record to show that FDA has informed the peer reviewers of other relevant IQA standards for "third-party" data, such as objectivity, utility, and reproducibility.

The CRE white paper explains further that the IQA standards require FDA to use the "best" available scientific data, not "all" published data, as urged by some commenters. FDA thus appears correct in relying primarily on the two Tyl et al. studies, because it regards them as the best studies. The white paper also discusses how many of the other studies urged on the Subcommittee by commenters appear to lack "utility" for quantitative risk assessment or appear deficient in other respects.

  • Click here for the CRE documents.