EWG Files Legal Challenge to FDA Mercury Health Advisory

For Immediate Release: 
Wednesday, December 11, 2002

WASHINGTON — The Environmental Working Group (EWG) today filed a legal challenge seeking to block the Food and Drug Administration (FDA) from issuing a weak proposed health advisory for mercury in seafood. New analyses contained within the filing show that FDA's advice fails to meet the standards for accuracy and scientific integrity of the Data Quality Act (The Act), a law passed in 2000. The Act requires all influential statements by the federal government to be accurate, reproducible, clear and based on the best peer-reviewed science. The FDA's proposed mercury health advisory meets none of these criteria.

Eight percent of American women of childbearing age have unsafe levels of mercury in their blood, according to the Centers for Disease Control and Prevention. Because the FDA provides no new specific advice on seafood consumption other than a vague recommendation to eat 12 ounces a week of a variety of fish, women and children who increase fish consumption will eat fish with unsafe levels of mercury.

A core component of the EWG challenge is the fact that if followed, the FDA's advice would actually increase the number of women of childbearing age with unsafe levels of mercury in their blood. FDA has withheld this information from the public in developing its advisory by failing to conduct or make public analyses examining the impact of its recommendation that anyone can eat up to 12 ounces of a variety of fish per week.

The advice was reviewed for public use at a Dec. 10-11 meeting between FDA officials and members of FDA's Food Advisory Committee, a panel of independent experts.

These experts rejected the consumer advice FDA officials were trying to give, saying the advisory on mercury contamination of tuna was "vague" advice to consumers that "gave short shrift" to children and required consumers to do math to understand it.

"FDA offers no explicit eating advice regarding tuna or any number of other fish with elevated mercury levels. The food expert panel rejected this non-advice to women about how to protect themselves and children from mercury pollution," said EWG vice president for research Jane Houlihan.

The Act was devised and enacted on behalf of industry lobbyists who wanted to create additional barriers for federal health, labor and environmental officials updating or changing a range of government standards.

FDA's advisory fails the Data Quality Act test in a number of ways:

  • It is not useful. If followed, FDA's advisory would actually increase consumption of fish with significant levels of mercury contamination and cause many more women to go through pregnancy with unsafe levels of mercury in their blood.
  • It is not clear, comprehensive or understandable. Except for the four fish on its "do not eat" list, the advisory provides no specific information on how to consume fish in a fashion that ensures that a woman will not expose her unborn child to an unsafe dose of mercury throughout pregnancy.
  • It is not transparent and reproducible. The agency has not examined what effect its advice would have on mercury levels in the general population if it were actually followed. If its officials have conducted such an analysis, they have not made it available to the public, making it impossible for anyone to reproduce the science and risk assessments behind the advice.
  • It is not based on scientifically sound practices. FDA's consumption advice is based on inadequate testing data and faulty analyses that lead the agency to recommend eating types of seafood that are not, in fact, safe to eat in the quantities recommended.

EWG will proceed through the appropriate agency administrative channels if FDA fails to correct the information. EWG will then file a lawsuit in Federal court, if necessary, to require FDA to produce a scientifically sound advisory. The Act can be used to file a lawsuit where a federal agency has consistently overruled a challenge internally through all of the administrative channels.

EWG is a nonprofit research and advocacy organization that uses the power of information to protect the environment and human health.

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