FDA changes course on mercury policy

Sea change likely to affect fish-consumption advisories nationwide

By Ben Raines
Staff Reporter

In 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.

Previously, 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.

The 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 to eat.

Some 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.

A 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 Atmospheric Administration.

"This 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."

Both the FDA and the EPA have a role in protecting the public from ingesting too much mercury from contaminated fish.

The EPA, which has a larger mission of protecting the nation's natural resources, investigates and regulates various contaminants, including mercury, in recreationally caught fish.

The FDA is charged with protecting the nation's food supply, including regulating how much mercury is allowed in commercially sold seafood.

The 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.

In 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 dose."

During 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 position.

"Right 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."

Leading mercury researchers around the nation expressed surprise when told of the FDA's change.

"If 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.

"This is really like a sea change at FDA," Stern said.

Acheson did not equivocate when asked if the FDA endorsed the EPA's safe level.

"The 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."

The new thinking appears to extend to some other contentious topics the agency has been wrestling with.

Acheson 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.

Mercury 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.

Also, 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.

As a result, the agency may have underestimated the mercury levels in many popular species.

The 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.

"If 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.

He 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.

Scientists 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.

"We 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."