Environmental Group Submits Data Quality Challenge

The Environmental Working Group (EWG) submitted a data quality challenge to the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) on December 22, 2003, one of the few challenges submitted by a nonprofit. The request challenges the 2003 FDA Consumption Advisory for mercury. FDA disseminated the advisory, "Advice For Women Who Are Pregnant, Or Who Might Become Pregnant, and Nursing Mothers, About Avoiding Harm To Your Baby Or Young Child From Mercury in Fish and Shellfish," in draft form during a Food Advisory Committee (FAC) hearing December 11-12, 2003. The previous version of the FDA advisory had been issued March 2001. The December 2003 FAC hearing convened to discuss FDA's recent studies that reveal mercury contamination of fish is more serious than federal scientists previously assumed. During the hearing, FDA officials stated the agency hopes to issue revised mercury and fish warnings by spring. EWG's petition questions the objectivity, utility and transparency of six statements within the new advisory. The group believes that the advisory concerning safe seafood consumption choices, in its current form, will adversely affect public health. Specifically, EWG asserts the advisory violates the OMB, HHS and FDA data quality guidelines because:
  • FDA's consumption advice is not "accurate" -- it outlines safe patterns and recommended doses that are higher than what EWG believes to be safe.
  • It does not disclose key underlying data and analyses for three statements and results from mercury testing, and therefore is not "transparent."
  • Failure to disclose some of the underlying data also prevents the advisory from being reproducible, a data quality requirement for "influential" information.
  • A number of advisory components, including the risk mitigation scenarios and mercury testing data, do not use sound science practices.
  • FDA violated objectivity requirements for peer review by not responding to comments and failing to subject the advisory to peer review.
  • The advisory does not provide comprehensive information on risk.
  • The information is incomplete.
  • The vague wording and implied advice compromise the utility of the advisory.
  • The consumption levels for tuna and the advisory title violate requirements of clarity.
The EWG claim that the FDA recommendations do not accurately reflect the dangers associated with eating seafood. According to the organization's assessment, following the advisory could expose a large percent of women to unsafe levels of mercury. To correct the information, EWG recommends that the FDA conduct a sampling program for seafood, provide detailed consumption advice that can be followed without any risk that is consistent with interpretations of the National Academy of Science, and develop public documentation of scientific assessments. EWG hopes that in filing a data quality challenge, the FDA will be forced to issue revised mercury warnings earlier than spring. While EWG treats the new advisory as a final disseminated FDA product, the FDA may likely reject the challenge asserting that the new advisory is only in draft form and not yet subject to the data quality guidelines. Even so, EWG could re-file the challenge if it feels the final version of the advisory has not improved enough.
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