Was the Food and Drug Administration overly sensitive to the commercial interests of the tuna industry when it established guidelines on fish consumption and mercury contamination? Documents released by a watchdog group are raising that question as well as others about the decision-making that went into the agency’s warning to pregnant women about which fish to avoid.
The documents, obtained this month under the Freedom of Information Act by the Environmental Working Group, include 1,000 pages of transcripts and other reports related to meetings and discussions that led to the January 2001 advisory not to eat fish like mackerel and swordfish. Among them were three meetings with the U.S. Tuna Foundation, Chicken of the Sea, StarKist, Bumble Bee and the National Food Processors Association.
The industry meetings in themselves were not unusual. But the Environmental Working Group and at least one member of Congress are questioning whether undue weight was given to the industry’s position, while the opinions of others were discounted.
Earlier this month the FDA itself acknowledged a need to revisit its own recommendations. In a rare move, just a year after its list was released, the agency announced a meeting of its Foods Advisory Committee to review mercury in seafood.
“We are going back because the Environmen-tal Working Group report had some things in there that went to the process, and we wanted to be sure there isn’t any question about that,” said Joseph A. Levitt, director of the agency’s Center for Food Safety and Applied Nutrition.
Where’s the tuna?
The FDA’s advisory warned pregnant women not to eat swordfish, king mackerel, shark and tilefish because of high levels of mercury contamination that could cause neurological defects or delays in mental development in their children. Mysteriously absent from the list was one of the most significant sources of mercury in the American diet, tuna.
The FDA said at the time it had identified those species of most concern to pregnant women, based on scientific evidence, the fact that Americans don’t eat dangerous levels of tuna and a desire not to confuse women. But Americans eat far more tuna than mackerel, tilefish or shark.
“We feel we have evaluated the science in an appropriate way, and our advisory is right on target,” Michael Bolger, director of the division of risk assessment of the Center for Food Safety and Applied Nutrition, said last May. Besides, Bolger added, if given too much information, women would stop eating all fish.
He based this opinion, he said, on the responses of three focus groups to statements that included the following: “Tuna steaks can be eaten three times a month. You can eat one and a half six-ounce cans of tuna every week with no problems.”
In a document released at the time, the FDA reiterated its reasoning: “The major points gleaned from the focus groups were to keep the message simple and direct,” the report said, adding that if pregnant women were told to limit consumption, they would interpret it to mean “do not consume.”
Underestimating their audience
The documents obtained by the Environmen-tal Working Group show that women were far more savvy than that. After being presented with detailed advisories that included specific advice about tuna, 30 out of 37 comments indicated that the respondents would still eat fish but avoid those with high mercury levels, many specifically mentioning they would continue to eat tuna but in limited amounts.
Only seven individual remarks in the transcripts equated limiting consumption with not eating any fish. More typical was this response from one participant: “My advice would be not to eat the mackerel, the shark and the swordfish. But I would also put in a note: You should limit your intake of the tuna and then, you know, eat the rest of the fish in moderation.”
“We have different conclusions on what the focus groups said,” Levitt said. “When we said ‘limit,’ they heard ‘avoid.’ “
Meanwhile, the FDA had three meetings with industry representatives, the documents show. The industry argued that tuna consumption “is not as great as anecdotal observations would indicate”–a position that belies industry efforts to keep canned tuna off the advisory list, as well as tuna’s place as the most-popular selling fish, accounting for one third of all seafood sales in the United States.
Nevertheless, the FDA agreed. The two-page rationale, as they called it, released in February 2001, said that those who do eat canned tuna consume, at most, only about seven ounces a week, or not enough to pose a risk of mercury contamination.
Following that reasoning, why advise pregnant women not to eat tilefish or shark, which are consumed seldom, if at all?
“We’ll never know exactly how much influence industry had,” said Jane Houlihan, vice president for research of the Environmental Working Group. “What we do know is that tuna was in the draft advisories and wasn’t in the final advisory. The FDA ignored the advice from every other group they called in. And we know the FDA’s public excuse for why they dropped tuna from the advisory is untrue. Their excuse is that people don’t eat enough canned tuna, so there is no need for an advisory.”
Randi Thomas, a spokeswoman for the U.S. Tuna Foundation, the trade association representing the domestic canned tuna industry, acknowledged her association’s influence. “I certainly hope we had an impact,” she said, “because we showed them the nutritional benefits of tuna.”
Old information, old risk
Critics of the advisory say the FDA based its recommendations on outdated research about safe mercury levels in the blood, with a limit eight times higher than was deemed safe by the National Academy of Sciences and the Environ-mental Protection Agency. If the FDA followed the National Academy standard, it would tell pregnant women not to eat any tuna steaks at all, and canned tuna only once a month.
Meanwhile, the U.S. Centers for Disease Control and Prevention has said that 10-15 percent of American women of child-bearing age have mercury in their blood at levels even higher than the EPA’s safe level, which means 600,000 children are exposed.
Scientists are still assessing the impact of mercury on fetuses. Some studies done in other countries have found mothers who ate fish with high levels of mercury bore children with scores on intelligence tests 7 to 8 points lower on a 100-point scale. Two studies linked neurotoxic effects like delays in mental development to chronic exposure to fish and marine animals with high levels of methyl mercury.
Mercury occurs naturally but is also released into the air in pollution. Rainwater brings it into streams and oceans, where bacteria transform it into methyl mercury. Fish get their dose as they feed on algae and other organisms.
Older, larger fish that eat other fish accumulate the most methyl mercury, so big carnivores such as swordfish and tuna pose the greatest risk to susceptible populations. Methyl mercury is stored in the flesh, so there is no way to remove it.
While the FDA reviews its advisory, Congress also may take action. Rep. Frank Pallone Jr., a New Jersey Democrat, questioned the agency’s motives in early March and asked the inspector-general of the Health and Human Services Department to investigate. Pallone has introduced legislation that would require the FDA to test mercury levels in fish, a program abandoned in 1998, and to set a safer threshold level for it in seafood.
