AS
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 this month 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 to reduce the risk of harming their fetuses.
The documents, obtained 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 that pregnant women not eat fish like mackerel and swordfish. Among
them were three meetings the F.D.A. had 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. However, 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, including consumer focus groups, were discounted.
Earlier this month the F.D.A. 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 Environmental 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.
The F.D.A.'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 F.D.A. 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.
"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, Mr. Bolger added, if given too much information like
guidelines distinguishing between safe and unsafe fish and those to be eaten
infrequently 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 F.D.A. 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."
The documents obtained by the Environmental Working Group show, however,
that women were far more savvy than that. After being presented with
examples of detailed health 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
that they would continue to eat tuna but in limited amounts. Only seven
individual remarks in the transcripts support the F.D.A. assertion that
limiting consumption was equated 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."
Mr. Levitt asserted: "We have different conclusions on what the focus
groups said. When we said limit, they heard avoid."
Meanwhile, the F.D.A. held three meetings with industry representatives,
the documents show. The industry arguments included a claim that tuna
consumption "is not as great as anecdotal observations would indicate" a
position that is at odds with the industry's eagerness to keep canned tuna
off the advisory list, as well as with tuna's place as the best-selling
fish, accounting for a third of all seafood sales in the United States.
Nevertheless, the F.D.A. 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 in the
process," said Jane Houlihan, vice president for research at the
Environmental Working Group. "What we do know is that tuna was in the draft
advisories and wasn't in the final advisory. The F.D.A. ignored the advice
from every other group they called in. And we know the F.D.A.'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."
Critics of the advisory say the F.D.A. based its recommendations on
outdated research about safe mercury levels in the blood, with the limit
eight times higher than was deemed safe by both the National Academy of
Sciences and the Environmental Protection Agency. If the F.D.A. followed the
National Academy's standard, it would tell pregnant women not to eat any
tuna steaks at all, and canned tuna only once a month.
Meanwhile, the Centers for Disease Control and Prevention has data
showing that 10 to 15 percent of American women of child-bearing age
600,000 have mercury in their blood at levels higher than the E.P.A.'s
safe level, putting their children at risk of harm.
Scientists are still assessing the impact of mercury on fetuses. Some
studies done in other countries have found that 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 fetal exposure to high levels
of mercury from fish.
While the F.D.A. reviews its advisory, Congress also may take action.
Representative Frank Pallone Jr., a New Jersey Democrat, questioned the
agency's motives last week and asked the inspector general of Health and
Human Services to investigate. Mr. Pallone has introduced legislation that
would require the F.D.A. to test mercury levels in fish, a program abandoned
in 1998, and to set a safer threshold level for it in seafood.