News Coverage
FDA panel to review seafood mercury warnings
Published March 29, 2002
Environmentalists are once again squaring off with federal regulators over the adequacy of warnings to pregnant women about mercury in fish, zeroing in on whether specific consumption limits should be proposed for tuna. Earlier this month (March), the Food and Drug Administration announced that one of its advisory groups would review the guidelines, after a prominent environmental organization criticized them.
The Environmental Working Group contends that the FDA bowed to pressure from the tuna industry, including San Diego-based Bumble Bee Seafoods and Chicken of the Sea International, when it issued an advisory last year about mercury risks.
The advisory, crafted after meetings with industry representatives, consumer groups and other parties, did not include a specific consumption limit for tuna, even though concerns about the commercially popular fish were voiced by at least one FDA scientist. The FDA has denied the environmental group's charge, and the industry says tuna contains far less mercury than the other fish the agency singled out.
It is only the latest round in a long-running debate that has divided scientists and regulators for years.
"It's a very heated topic. I've listened to both sides and I've heard good and bad on both," said Steve Otwell, a seafood specialist at the University of Florida's Institute of Food and Agricultural Sciences.
Mercury can damage the brains and nervous systems of developing fetuses. Some fish, particularly large predatory species, contain high levels of methylmercury, which enters the aquatic environment from coal-fired power plants and other pollution sources.
The FDA advisory, originally issued in January 2001, says pregnant women, those who may become pregnant, nursing mothers and young children should not eat shark, swordfish, king mackerel or tile fish. It recommends those groups limit consumption of other fish to 12 ounces a week.
But the Environmental Working Group contends the advisory should include more specific, and stricter, consumption limits for tuna and some other fish based on mercury limits that have been endorsed by the Environmental Protection Agency and the National Academy of Sciences. Those standards are much stricter than the ones used by the FDA.
"FDA has a program that is failing to protect public health," Jane Houlihan, vice president for research at the environmental group, said.
To bolster its case, the group cites transcripts of focus group sessions the FDA convened as it crafted the advisory. It singles out several comments from Dr. Alan Levy, an FDA official. He told one focus group that "studies indicate that the action levels that we have in place for fish are not protective enough for this - the fetuses."
Levy also said that "to lower the action levels so they're protective of fetuses, it would actually put the availability of certain kinds of fish in question," including tuna.
However, at other points, Levy says the agency is using "ten-fold safety factors" and "this is not necessarily a big problem."
The FDA tested some advisory language that included specific consumption limits for fresh and canned tuna, since it is the most widely consumed fish in America. But the agency ultimately rejected specific advice for tuna because, it said, "consumption is not as great as anecdotal observations would indicate."
FDA officials also said the focus groups "indicated that a "limit consumption' message for pregnant women would be interpreted as a "do not consume' message." Many nutritionists consider fish an important low-fat source of protein.
But the Environmental Working Group says the FDA's conclusion is contradicted by the transcripts. Of 37 comments from participants reacting to consumption limits, only seven said such warnings would prompt them to stop eating fish, the group said.
"They were testing a tuna advisory. They met with the industry and they dropped it," said Richard Wiles, the group's senior vice president. FDA officials say they were not swayed by the industry. Tuna companies were clearly worried about the impact of consumption guidelines. One document presented to the FDA by Chicken of the Sea, Bumble Bee and Starkist warns, "An unfounded health advisory could easily reduce consumption by 50 percent or more."
The seafood industry also questioned the credibility of the mercury limits endorsed by the National Academy of Sciences, noting that another study appears to contradict the one on which the tougher standards were based. "We just didn't think it was fair to highlight tuna unless tuna itself raised a significant issue," said Dave Burney, executive director of the San Diego-based U.S. Tuna Foundation. "Tuna's mercury levels are significantly below those species of fish" that the FDA ultimately recommended that pregnant women avoid.
"If you look at any of the consumption studies that have been done by the Department of Agriculture, the consumption levels for tuna fish as a category don't reach the levels where you would have concern about mercury. We believed, and we still believe, that people like the Environmental Working Group continue targeting tuna because it gets the interest of the press," Burney added.
The FDA also defended its conclusions.
"The agency believes the advisory we have issued is based on the best information available. The process we used was open and transparent," a spokesman said.
Nonetheless, the day after the Environmental Working Group leveled its criticism, the agency announced it would convene a meeting of its Food Advisory Committee to re-examine the advisory. The committee is made up of outside food and health experts and is expected to meet in June.
Scientists are divided on the issue.
"Proper advisories are there. I think we're using the best science available," said Otwell of the University of Florida. But Thomas Burke, a public health professor at Johns Hopkins University in Baltimore who was part of the National Academy of Sciences panel that looked at the issue, said the FDA should be doing more.
"I would like to see a more aggressive attempt to put useful information out there," he said. "I don't know that we have adequate monitoring of fish like we do for other foods."