4 April 2003
changes course on mercury policy
change likely to affect fish-consumption advisories nationwide
By Ben Raines
what leading scientists describe as a landmark change in the government's
regulation of mercury, a senior U.S. Food and Drug Administration
official says his agency now uses the U.S. Environmental Protection
Agency's much lower safe level for mercury in the human body.
the FDA had maintained there was no danger in having four times
more mercury in the human body than the safe level set by EPA.
reversal, along with other policy shifts described by the FDA in
an inteview this week with the Mobile Register, will likely affect
the mercury advisories issued by states for recreationally caught
fish. It will almost certainly lead to significant changes in the
advice the FDA gives to women and children about what fish are safe
regulators say the FDA's stance also may indicate that the agency
plans to provide fish-consumption advice for men, who are not included
in the agency's current warning, which targets only women and children.
paper in this month's Journal of the American Medical Association
represented the first outward sign of the FDA's new position. The
paper was written by top officials from the FDA, the EPA, the Centers
for Disease Control and Prevention, and the National Oceanic and
is really a landmark paper," said the EPA's Kate Mahaffey,
who helped author the article. "It's really a consensus on
what we know about mercury."
the FDA and the EPA have a role in protecting the public from ingesting
too much mercury from contaminated fish.
EPA, which has a larger mission of protecting the nation's natural
resources, investigates and regulates various contaminants, including
mercury, in recreationally caught fish.
FDA is charged with protecting the nation's food supply, including
regulating how much mercury is allowed in commercially sold seafood.
FDA's former position regarding the safe level of mercury is well-documented
in official publications and has caused longstanding disagreement
between that agency and the EPA.
fact, during a public meeting discussing the FDA's mercury policy
last July, the EPA's Mahaffey and the FDA's Mike Bolger, whose name
appears with Mahaffey's on the new paper, got into a terse and heated
argument while discussing the science behind the safe level or "reference
that meeting, an internal FDA panel challenged the agency to publish
a scientific rationale for its higher safe level. That has not happened,
and now the FDA is taking pains to distance itself from its old
now, the FDA is not making that statement," said Dr. David
Acheson, the newly appointed chief medical officer in the FDA's
science office. "Whether they did in the past, I don't know.
That may have been based on past thinking."
mercury researchers around the nation expressed surprise when told
of the FDA's change.
the FDA is now cooperating closely with the EPA and they are on
the same page, this makes a very big difference not only in terms
of government policy for commercial seafood, but it provides great
clarity for states on how they should handle their mercury advisories,"
said Alan Stern, who coordinates mercury research for the state
of New Jersey and who served on the National Academy of Sciences
panel that studied and endorsed the EPA's safe level.
is really like a sea change at FDA," Stern said.
did not equivocate when asked if the FDA endorsed the EPA's safe
FDA is basing its advisory on the EPA's reference dose," Acheson
said. "Are we formally endorsing it? I'm not aware, but we
are certainly using it and pay attention to it."
new thinking appears to extend to some other contentious topics
the agency has been wrestling with.
indicated that the FDA plans to add more fish to its so-called "Do
Not Consume" list if new mercury testing reveals that a species
tends to have a high level of mercury. Now, there are only four
fish on the list: swordfish, shark, tilefish and king mackerel.
Environmental groups have accused the agency of caving in to pressure
from the fishing industry instead of listing additional fish that
scientists believe have high mercury levels.
tests of fish by the Mobile Register in the last two years revealed
that a number of species -- including grouper, amberjack, redfish,
cobia and yellowfin tuna -- may contain so much mercury they would
qualify for the FDA's list.
the Register has shown that the mercury databases used by the FDA
for selecting the fish on its list are fundamentally flawed. EPA
scientists have described the FDA data as essentially useless for
determining whether a species is safe to eat.
a result, the agency may have underestimated the mercury levels
in many popular species.
National Marine Fisheries Service is in the process of testing 2,500
samples of Gulf of Mexico fish for mercury. The fisheries agency
plans to test Pacific and Atlantic fish as well.
the data demonstrates that other fish should be put in that category,
then I think we would add more fish to the list," Acheson said.
also said the agency was reconsidering the advice it gives to women
and children regarding how much canned tuna is safe to eat. The
FDA's current advice states that women and children are safe eating
two cans of tuna a week.
say that two cans of tuna a week would push a 130-pound woman over
the EPA's safe level. In fact, just over one can a week would contain
all the mercury a 130-pound woman could safely handle, according
to EPA calculations. As little as half a can a week could push a
4- or 5-year-old child over the safe level.
have these things under consideration right now in regards to canned
tuna," Acheson said. "What FDA is doing is trying to keep
its advisory apace with the science and the data."