During the summer of 2008, seven individuals expert in a range of scientific disciplines, identified below, completed an external peer review of a Food and Drug Administration (FDA) draft document subsequently published under the title “Report of Quantitative Risk and Benefit Assessment of Consumption of Commercial Fish, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children and on Coronary Heart Disease and Stroke in the General Population.” The peer reviewers were asked to provide individual, written comments in response to a specific set of questions and to provide any other comments on the draft they deemed appropriate. FDA made revisions to the draft assessment in response to peer review comments and then also in response to comments provided by other Federal agencies before publishing it for public comment in 2009. During that public comment period it was sent back to the peer reviewers for a second round of review, primarily to obtain their views on how FDA had addressed their original comments and to obtain any further recommendations they might have. This peer review report contains their comments verbatim followed by responses from FDA on those comments that requested changes or clarifications.
FDA is issuing this peer review report now to accompany the public release of the current version of that assessment, now entitled “A Quantitative Assessment of the Net Effects of Commercial Fish Consumption During Pregnancy on Fetal Neurodevelopment (As Measured by IQ and also by Early Age Verbal Development in Children).” The assessment describes quantitative estimates of the net effects on fetal neurodevelopment in children from maternal consumption of commercial fish, taking into account both adverse effects from methylmercury and beneficial effects from fish, presumably from one or more nutrients in the fish. It is narrower in scope than the version of the assessment last reviewed by the peer reviewers in that it no longer includes an assessment of the effect of fish consumption on risk of fatal coronary heart disease and stroke. That part of the assessment remains in draft as published in 2009. While the verbatim peer review comments contained in this report include those relating to the assessment of risk of fatal coronary heart disease and stroke, FDA is only responding at this time to those comments germane to the assessment of fetal neurodevelopment. The comments on coronary heart disease and stroke are being held in the event that that portion of the assessment is completed.
We greatly appreciate the peer reviewers’ comments and suggestions. Since this peer review is a follow-on to the first peer review provided by the same individuals, the charge questions to the first peer review and to this follow-on review are both set forth below. The reviewers’ full responses to the follow-on charge questions and their other comments are provided without attribution to the specific reviewer. The last section of this document identifies issues raised by the peer reviewers and sets forth whether FDA agreed or disagreed with the comments and describes the actions the agency took in response.
Download the Full Peer Review (PDF: 350KB)