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Mercury is toxic
to the developing fetal brain and is a poison of growing concern
to health authorities nationwide. When the U.S. Food and Drug
Administration's latest health advisory for mercury in seafood
was issued in January 2001, the agency came under immediate
fire from independent scientists and public health activists
for failing to adopt the recommendations of a National Academy
of Sciences study on mercury (NAS 2000), and for not providing
pregnant women with complete information on what fish to avoid
during pregnancy - particularly tuna.
Speaking to the
press in May 2001, Dr. Robert Goyer, chairman of the NAS committee
on mercury toxicity, criticized the Agency's health advisory
for mercury, saying "The F.D.A. should be providing people
with the best information and let them be the judge. The F.D.A.
has stopped short of what it should have done."
Newly available,
internal FDA documents obtained by the Environmental Working
Group (EWG) reveal that FDA, under pressure from the seafood
industry, is deliberately withholding critical information
from pregnant women on mercury-contaminated tuna and other
fish, and using "focus
group" sessions as a justification.
In May of 2001,
FDA's Director of the Division of Risk Assessment, Michael
Bolger, told the press that the agency had conducted focus
groups and concluded that if women were given a more comprehensive
list of fish that should be avoided or eaten only in moderation
during pregnancy, they would simply not eat fish at all. To
investigate this claim, the Environmental Working Group (EWG)
obtained and analyzed 1,036 pages of focus group transcripts
under the Freedom of Information Act.
We found that the
word-for-word account of focus group discussions flatly contradicts
Bolger's assertion. We also found compelling evidence that
the agency is failing to protect the public from mercury-contaminated
seafood. Internal FDA focus group transcripts considered together
with publicly available FDA documents, show that the agency
is failing to regulate mercury levels in seafood, has shut
down its mercury monitoring program, has not issued an enforceable
limit for mercury in fish, and has not implemented the mercury
education program that it promised.
Stunning
admissions by FDA official in focus group transcripts
FDA's own focus
group transcripts directly refute Dr. Bolger's claim that
women would stop eating seafood if given detailed information
on mercury levels. In fact, when presented with draft health
advisories, an overwhelming majority of the participants said
that they would keep eating fish but avoid those with high
mercury levels (30 of 37 individual comments) - exactly the
behavior that the FDA was aiming for (Table
1 and Table
2).
But beyond what
FDA officials were told by consumers are several stunning
admissions FDA officials made to participants during those
same sessions. EWG's detailed review of 1,036 pages of word-for-word
transcriptions of 11 FDA-sponsored focus groups in Denver,
Boston, and Calverton, Maryland conducted in October and November
2000, reveals:
1. FDA is withholding
from pregnant women information on their need to limit consumption
of tuna in order to protect their babies. The agency's
January 2001 advisory contains no mention of tuna, yet in
the documents obtained by EWG, a senior FDA scientist reveals
that:
"... the dilemma
that we have is 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. We would lose some fish."
Then he is asked: "Like King Mackeral [sic], shark, and
swordfish?" He replies, "Well, those in particular,
but also tuna." (emphasis added, Macro
International, Inc. 2000i - Boston, November 8, 8 pm, pg 65).
2. Seafood that
is technically "safe" according to FDA's mercury
action level is actually endangering public health.
A senior FDA scientist
admits to a Boston focus group that supposedly safe seafood
could put a fetus at risk for neurological damage: "...
the action levels that we have in place for fish are not protective
enough for this - the fetuses..." (Macro
International, Inc. 2000i - Boston, Nov 8, 8 pm, pg 65).
FDA scientists
acknowledge the health risks during the focus groups. At one
point during the focus groups, a woman whose child has Attention
Deficit Hyperactivity Disorder pressed an FDA scientist: "I
mean, now you find a lot of Attention Deficit Disorder and
they're really not saying where it is coming from... But maybe
it could be coming from eating too much fish - you know -
I mean, is that a possibility?" The scientist replies,
"Yes, that's why we're - yes, that is a possibility.
That is why we're interested in this." "So my daughter
is on medication, now, because I ate fish... ," she asks.
FDA's scientist responds, "- now that we have this research,
that now is a possibility." (Macro
International, Inc. 2000i - Boston, Nov 8, 8 pm, pp 70-71)
3. FDA initially
mentioned tuna in its draft mercury advisory but then dropped
it after three meetings with the seafood industry.
The agency's draft
focus group materials contained warnings for pregnant women
such as: "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." (see, for example, Macro
International, Inc. 2000j - Calverton, MD, Nov 14, 6 pm, pp
32). At the Calverton session, an FDA senior scientist
reiterates the potential hazards tuna poses to pregnant women
and extends the warning to toddlers and even adult males:
"The advice
for pregnant women is once a month or less for things like
king mackerel, tuna steaks, whatever." (Macro
International, Inc. 2000k - Calverton, MD, Nov 14 2000, 8
pm, pp 45-46)
"It is prudent,
particularly for pregnant women to avoid these high mercury
fish and moderate their tuna fish consumption..." (Macro
International, Inc. 2000j - Calverton, MD, Nov 14, 6 pm, pg
72).
"I have a
fifteen month old and he loves tuna. I would want to know,
should I be limiting the amount of tuna that I give him?"
asks a focus group member. FDA's scientist replies, "It
would be, you know, prudent to cut back if he's eating more
than a can and a half a week." She asks for clarification:
"So, it's the same can and a half for a fifteen month
old as it is for him, you know, for an adult male?" He
replies, "That is our - yes. It would be the same. It
depends on how much you're doing." (Macro
International Inc. 2000k - Calverton, MD, Nov 14, 8 pm, pp
48-49).
While crafting
language for the advisory, FDA met privately three times -
September 25, November 6, and November 22, 2000 - with Chicken
of the Sea, StarKist, Bumble Bee, U.S. Tuna Foundation, and
National Food Processors Association (FDA 2000a, 2000b, 2000c).
The agency's final advisory, issued January 12, 2001, was
stripped of any reference to tuna (FDA 2001a).
4. FDA official
admits that the agency will rely on the seafood industry,
not doctors, to educate women about the hazards of mercury
in fish.
The seafood industry,
however, has yet to warn women of the potential dangers of
mercury. In fact, the industry used a recent study on the
benefits of fish consumption (specifically, of Omega 3 fatty
acids) to promote tuna consumption for pregnant women: "...this
new study adds to the long list of startling health benefits
scientists believe Omega-3s fatty acids provide to pregnant
women and small children. The most convenient, economical
source of Omega-3s for moms and kids is, quite simply, canned
tuna!" (U.S. Tuna Foundation, 2001). This press
release provides a clear indication that the tuna industry
has no plan to protect its customers from the dangers of mercury
by steering them toward safer fish.
Environmental
Working Group
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