Environmental Group Submits Data Quality Challenge
by Guest Blogger, 2/11/2004
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.