News Coverage
FDA to review mercury levels in seafood
Published July 21, 2002
In an unusual move, the Food and Drug Administration said it will begin a three-day review on Tuesday of the safety of its acceptable mercury level in seafood, particularly regarding whether levels are set low enough to prevent harm to developing fetuses in pregnant women who consume fish.
Although the agency maintains levels are safe to protect the public from undue mercury exposure, the Environmental Working Group, an environmental advocacy group in Washington said internal FDA documents disclose agency scientists have admitted allowable mercury levels may be too high to protect fetuses.
The FDA is the only governmental agency that has refused to adopt the mercury exposure levels recommended by the National Academy of Sciences and they have been unable to provide a rationale for this, Richard Wiles, senior vice president of EWG, told United Press International.
In 2000, a National Academy advisory committee on toxic mercury levels said the FDA's current acceptable mercury level protects most Americans. However, the committee said the levels are high enough that approximately 60,000 children may be born each year with cognitive and neurological problems attributable to mercury exposure while in the womb. Wiles said, however, the number of pregnancies at risk could be six times that number. "It could affect about 400,000 pregnancies a year and that is a huge public health issue," he said.
The FDA issued a consumer advisory last year recommending pregnant women and those who may become pregnant to avoid eating the four fish with the highest mercury levels: shark, swordfish, king mackerel, and tilefish. The agency said these women could eat 12 ounces of other fish species safely per week, but emphasized they should choose a variety of different fish.
In announcing Tuesday meeting of its food safety advisory committee, the FDA said in a written statement it "stands behind the process that led to its current Consumer Advisory on this subject." This being the case, it is unclear why the agency has convened an advisory committee because it generally does not review issues unless new data have come to light. The agency declined UPI's request for an interview.
"They're so obviously out of step with the science they have to do something," Wiles said. He speculated that "there is some sort of ongoing debate within the FDA whether the level is adequate."
Thomas Burke, a professor of health policy at Johns Hopkins University who was part of the National Academy of Sciences committee that made the initial mercury recommendations, said, "Studies indicate that a number of women of child-bearing age are consuming fish at levels that may put them at higher risk of having children with neurodevelopmental problems."
Burke told UPI, "The risks are very low for most of the population, but we need to take a hard look at women and maybe all of us who consume high levels of fish."
The difficulty in determining a safe mercury exposure level is lack of data, Burke said. "We need to know patterns of consumption and we need to know levels of mercury in particular fish so we can make better informed decisions," he said.
The Environmental Working Group also charged FDA with removing its recommendation to avoid tuna due to pressure from tuna industry giants, including StarKist and Bumblebee. "Rather than following the best available science to develop a health advisory for pregnant women, the agency has rather blatantly been doing the business of the seafood industry," Wiles said.
Burke said the levels of mercury in canned tuna are unknown, however. "We don't know just what the levels are in canned tuna," he said, adding "a lot of the debate would just disappear if we just had better information." He urged the FDA to "rather than saying it's not a problem, assure the public (by reporting), 'Here are the levels and they are below risk levels.'"
Such a conclusion may be impossible because the agency stopped testing mercury levels in fish in the late 1990s, Wiles said. "Now they don't test fish for mercury at all."
Wiles said his group will present an exposure model to the FDA's committee showing that the agency's mercury standard "doesn't protect pregnant women who have moderate fish consumption."
The EWG's goal is to persuade the FDA to "seriously revisit the mercury standard" and "develop a standard where the goal is to protect all pregnancies from unsafe levels of mercury," Wiles said, adding, "That's not their goal right now."
In the meantime, Burke recommended consumers eat in moderation fish known to have high mercury levels. If information on mercury becomes available in other fish, people should avoid those with the highest mercury levels. Pregnant women or those planning to have a child should monitor their fish consumption carefully, "not that it's a major risk factor, but it is an avoidable risk factor," Burke said.
The EWG position seems to have strong support in Congress. At least one congressman, Frank Pallone, D-N.J., wrote acting FDA commissioner Lester Crawford last week, expressing his concern several members of the advisory committee have ties to the seafood industry, which could affect their impartiality. Pallone also noted FDA's refusal to adopt levels set by the National Academy.
In addition, five senators, including Edward Kennedy, D-Mass., sent a letter to the FDA in February, criticizing the agency's refusal to adopt the Academy's recommendation and "leaving pregnant women, women of childbearing age, and other seafood consumers vulnerable" to mercury exposure.
The FDA committee will present its final recommendations on Thursday. The agency is not bound by the committee's advice, but it generally follows such recommendations.