Focus Pocus

Internal documents reveal that the FDA is failing in its public health obligation to warn pregnant women about mercury in tuna.

March 1, 2002

Focus Pocus: Recommendations

FDA has a 33-year history of failed health advisories and nonenforceable mercury contamination guidelines. The agency's monitoring programs do almost nothing to test the most commonly eaten fish for mercury. When its limited testing shows high mercury contamination, the agency fails to protect the public. The focus group transcripts analyzed here show that FDA officials admit these failures when pressed by focus group participants but ultimately caved to the wishes of the fish industry when developing thier final health advisory for mercury in seafood.

We recommend the following actions to protect pregnant women and children from dietary exposure to mercury:

1. Convene Congressional oversight hearings on FDA procedures.

EWG's review of FDA's focus group transcripts reveals that FDA is withholding critical information from the public on mercury-contaminated fish. FDA scientists admit during the focus groups that current health standards and enforcement procedures are inadequate. Despite growing scientific support for stronger health advisories, monitoring and enforcement, FDA has not responded. Independent Congressional review of the focus group transcripts will highlight the inadequate testing, monitoring, enforcement and consumer education procedures currently used at FDA.

2. Adopt the NAS recommendations for new fish advisory levels and expand the list of species to avoid during pregnancy.

Ten percent of American women enter pregnancy with elevated methylmercury levels. FDA safeguards, which are based on average exposures, do almost nothing to protect these high exposure pregnancies. If these women follow FDA's advice of 12 ounces of any fish a week, they could easily expose their fetuses to a level of methylmercury that presents a risk of adverse neurological effects. The National Academy of Sciences stated that the EPA action level is justifiable, which is eight times more stringent than the current FDA enforceable action level. NAS also recommended that a revised action level be developed that reduces the differences among agencies. The focus groups show that women can and will follow detailed health advisories about which species to avoid during pregnancy. Pregnant women have a right to this information, and FDA has a duty to provide it.

3. Improve monitoring of fish for methylmercury contamination.

A major flaw in FDA's system is the agency's lack of comprehensive data on methylmercury in fish. In January 2001, FDA recommended that pregnant women avoid consumption of king mackerel based on methylmercury levels from a study published in 1979. There are many other species where the data on methylmercury contamination are similarly outdated, but where the available information indicates a potential problem. FDA must immediately expand its methylmercury monitoring program to include a host of fish where the data indicate that pregnant women and their children could receive a potentially unsafe exposure from a relatively small amount of fish. Congress should include funding in the Fiscal Year 2003 Agriculture Appropriations bill to restart the fish tissue inspection process of domestic and imported seafood.

4. Protect all babies from mercury, not just the "average" baby.

FDA needs to move beyond its antiquated and biologically implausible risk assessment methods based on average people and average fish and adopt state-of-the-art risk assessment techniques that provide a much more realistic picture of mercury exposure and risk as it is distributed throughout the population. It is not sufficient to protect the population from average exposures when it is clear that many individuals have far greater than average exposures for extended periods of time. FDA must use probabilistic risk assessment methods to assess the fetal exposure to mercury and then set standards that protect all pregnancies. The focus groups transcripts show that senior FDA scientists agree with NAS that current action levels are not protective enough for pregnant women and fetuses.

5. Monitor human exposure and health.

The U.S. lacks a comprehensive program to track disease and exposure to environmental contaminants like methylmercury. Congress should appropriate funding for the Centers for Disease Control and Prevention to build a health-tracking network and to continue biomonitoring programs in Fiscal Year 2003.

6. Reduce mercury pollution at its source.

Mercury emissions from coal-fired power plants, the largest man-made source of environmental mercury, are currently completely unregulated. Federal decision-makers should require power plants to reduce their mercury pollution by 90% and ultimately move away from polluting sources of power.