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.