Summary: EWG's Legal Challenge

December 2003

EWG will use a newly enacted law (the Data Quality Act (DQA) of 2001) to mount a novel legal challenge to the Food and Drug Administration's (FDA) highly controversial pending "advice" to consumers about how much tuna and other fish they can safely eat without risking their health, and in particular the health of fetuses, infants and young children, from mercury exposure.

The DQA was originally conceived by and enacted on behalf of industry lobbyists who wanted to create additional barriers to federal health, labor and environmental officials updating or changing a range of government standards. The law requires a "sound science" basis for any new government standard or protection. It also requires that the new standard meet certain criteria of: quality, utility, objectivity, transparency and reproducibility of information. The criteria are based on guidelines in effect at the relevant agency (in this case FDA) and the White House Office of Management and Budget (OMB).

EWG will file the challenge the week of December 15, contending that the FDA is failing to meet the scientific and regulatory requirements of the Data Quality Act in proposing to tell American women that it is safe to eat 12 ounces of tuna a 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.

In fact, the agency's proposed advice to consumers — eat 12 ounces of fish a week — if followed, could result in more women getting unsafe levels of mercury in their bodies than they currently do — assuming they have no other exposure to mercury than that from tuna. Eight percent of American women of childbearing age — about four million women — have unsafe levels of mercury in their blood.

Basis of the legal challenge

The advice FDA is proposing to give women fails the Data Quality Act test in a number of ways:

• It is not useful. If followed, FDA proposed 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 proposed 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 proposed 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.

How the challenge will work

EWG files its challenge with FDA, and the agency must review the challenged decision based on DQA guidelines of OMB and Department of Health and Human Services. A successful challenge under Data Quality Act demands rejection of federal agency guidance or rulings, which do not meet the basic standards of quality, and correction of the information to comply with the guidelines.

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