Draft Risk and Benefit Assessment Report and
Draft Summary of Published Research

Report of Quantitative Risk and Benefit Assessment of Consumption of Commercial Fish, Focusing on Fetal Neurodevelopment Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population
and
Summary of Published Research on the Beneficial Effects of Fish Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints

Federal Register Notice of Availability, January 21, 2009
Docket No. FDA-2009-N-0018

The Food and Drug Administration (FDA) is announcing the availability of two draft documents. The first is entitled ‘‘Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population’’ (draft risk and benefit assessment report). The draft risk and benefit assessment report describes an analysis done by FDA that results in quantitative estimates of the net effect on fetal neurodevelopment in children of maternal consumption of commercial fish, as measured by verbal development and the net effect of eating commercial fish on coronary heart disease and stroke in the general population. Effects with respect to each of these health endpoints has been associated in the scientific literature with methylmercury exposure (which primarily occurs through fish consumption) and with the consumption of fish and of omega-3 fatty acids, which are found in fish.

The second draft document entitled ‘‘Summary of Published Research on the Beneficial Effects of Fish Consumption and Omega-3 Fatty Acids for Certain Neurodevelopmental and Cardiovascular Endpoints’’ (draft summary of published research) is a compendium of research prepared by FDA for use in developing its quantitative risk and benefit assessment. When peer and public review are complete, the draft risk and benefit assessment report and the draft summary of published research are intended to add to the growing body of scientific literature investigating the likelihood, magnitude, and direction of health impacts linked to consumption of commercial fish. FDA is seeking public comment on the draft risk and benefit assessment report and the draft summary of published research.

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Report Documents

• Draft Risk and Benefit Assessment Report
  • Section I: The Purpose of Risk and Benefit Assessment for Methylmercury
  • Section II: Exposure to Methylmercury in the United States
  • Section III: Scientific Basis for Risk and Benefit Assessment
  • Section IV: Quantitative Risk and Benefit Assessment Modeling for Selected Indicators of Fetal Neurodevelopment, Coronary Heart Disease, and Stroke
  • Section V: Quantitative Risk and Benefit Assessment Results for Selected Indicators of Fetal Neurodevelopment, Fatal Coronary Heart Disease, and Fatal Stroke
  • Appendix A: Technical Description of the Risk and Benefit Assessment Methodology
  • Appendix B: Modeling Results
  • Appendix C: Methodology And Results From Carrington and Bolger (2000)
  • Appendix D: Estimated Exposure in the Daniels et al. (2004) Cohort
  • References
• Draft Summary of Published Research
  • Section A: Cardiovascular
  • Section B: Neurodevelopmental
  • References
• Peer Review Report