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Posted Friday, April 24, 2009 1:47 PM

Smackdown! EPA, FDA and Mercury in Fish

Sharon Begley

It isn’t every day that one federal agency says the work of another has such “serious scientific flaws” that the work is “not a product [we] should endorse as it does not reach the level of scientific rigor.” Nor is it every day that federal agency #1 (as we’ll call it) says that while federal agency #2 may have tried to get its act together in response to earlier criticism, the work is “essentially unchanged, and . . . [still] scientifically flawed.”

Yet this is how the U.S. Environmental Protection Agency characterizes an analysis by the U.S. Food and Drug Administration. The comments from EPA are in response to an analysis by FDA, issued in the waning days of the Bush administration, that lays the groundwork for a change in federal policy which currently warns people to avoid high-mercury fish and eat lots of the low-mercury kind (a list of what’s high and what’s low can be found here). FDA's analysis would support telling people to eat all the high-mercury fish they want. FDA had received 248 responses by the time the comment period closed earlier this week. (My thanks to the Environmental Working Group, whose own comments on the FDA proposal pointed me to and quote from the EPA response. You can find EWG’s letter here; the docket is a nuisance to navigate around, but if you go to that page and click on the pdf icon, you’ll get EWG’s comment. EPA’s is here; click on the Word icon.)

Here's the backstory. In January, FDA published what’s called a draft assessment of the benefits and risks of eating fish. It asked for public comment. While it’s hard summarize the technically dense, 350-page report, FDA’s conclusions seem to be that mercury risks are very small, and that telling women to eat more fish has greater public health benefits than telling them to eat low-mercury fish. (The focus is on women because fetuses are at the highest risk from mercury. Mercury is a neurotoxin and the developing brains of fetuses and kids are most vulnerable to its poisonous effects.) Next step (though FDA doesn't say this): stop telling people to limit their consumption of high-mercury fish.

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Bizarrely, FDA has structured the choice as “either/or:” Eat more fish, or eat low-mercury fish. For reasons I can’t imagine, FDA left out of its analysis the scenario that combines the two: eat more fish, but only low-mercury fish. In every scenario it ran, fish benefits and mercury damage largely offset each other. Obviously, the eat-more-low-mercury fish approach would have greater benefits than doing one but not the other—as researchers (and FDA) have been saying for years. Why would you want to wipe out the brain-healthy effects of fish by having a little neurotoxin on the side?

Predictably, the fishing industry and professional mercury risk-deniers have lauded the FDA analysis. Industry comments describe it as “a comprehensive analysis supporting consumption of seafood.” David Martosko, research director at the Center for Consumer Freedom, wrote in his comments that FDA’s analysis shows that the current FDA/EPA advisory about limiting how much high-mercury fish you eat “has been sending consumers the wrong message.” He urges that the advisory be withdrawn or revised: just tell women to eat more fish, and stop telling them to consider the mercury levels in different fish.

Research scientists and EPA, however, say FDA’s analysis is junk science. For one thing, FDA’s estimate of mercury risk is based on a 22-year-old study in Iraq that observed the age when kids first talk—but the children’s actual ages were unknown. FDA “adjusted” that risk estimate with data from the Seychelles Islands, where the harmful effects of mercury were obscured by the benefits of eating fish. A report from a committee of the National Academy of Sciences concluded in 2000 that the Iraq and Seychelles studies are not the best evidence, and urged the government to use data from a study in the Faeroe Islands. FDA didn’t.

Which is one reason why EPA was so scathing in its comments on its sister-agency’s analysis. It takes FDA to task for dozens of errors and faulty assumptions. One example: FDA relied on research on the neurodevelopmental risks mercury poses which “had been completely abandoned by the scientific community as a basis for risk assessment for more than a decade,” says EPA. EPA’s comments go on to note many other “questionable, faulty or unfounded choices with the effect of boosting benefits or reducing risks from seafood consumption above what is justified scientifically,” EWG says in its comments. EPA concludes that “a fish consumption advisory strategy based on the design of the FDA draft analysis would be highly inconsistent with what is generally considered to be proper public health practice.”

In its soon-to-be 100 days in office (April 29), the Obama administration has begun to clear out the detritus of the junk science and politicized science it inherited from the Bush years. It will be interesting to see whether the idea that it’s fine to eat fish containing high levels of a neurotoxic compound will survive the culling or be recognized for the bad science it is.

One final note: as the battle over what information the public should be getting about fish and mercury rages, the tuna industry might need to watch its flank. In a little-noticed decision this Monday, the U.S. Supreme Court declined to hear an appeal from Tri-Union Seafoods, which makes Chicken-of-the-Sea tuna. Tri-Union sought to block a lawsuit by a New Jersey woman who got methylmercury poisoning from eating its product. The company argued that since the FDA considers canned tuna safe enough to be sold without a warning label, individuals can’t sue over alleged injuries. The Court’s decision lets stand a ruling by an appeals court that the lawsuit can proceed. The plaintiff, Deborah Fellner, ate almost noting but canned tuna for five years, and got a classic case of mercury poisoning, according to her lawsuit. She argues that the company was negligent in failing to warn her of its tuna's high mercury content.

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Member Comments

Posted By: GGibbons (April 27, 2009 at 4:03 PM)

This blog posting does a good job of making the Environmental Working Group’s points, but perhaps it misses the larger points made by the FDA’s work in this case.

For starters, people in the U.S. are already eating low-mercury fish.  The "average" commercial fish in the U.S., weighted for consumption, contains 0.086 ppm methylmercury.  As a reminder, the federal level of concern is 1.0 ppm.  So, the fish we eat on average already have mercury nearly 12 times lower than the level of concern.

Federal fish advice recommends that moms-to-be avoid four fish (shark, tilefish, swordfish and king mackerel).  It doesn’t seem like hard advice to follow, but research that measures the impact of this advice shows that moms interpreted it coarsely.  And reduced consumption of all fish.  The average pregnant mom in the U.S. currently eats just 1.89 ounces of fish a week.

Large-scale studies show that babies of moms who ate 12 or more ounces of fish a week had the best brain and eye development..

So what should we be focusing on?  Further segmenting fish and fish eating populations with cards, charts and graphs?  Or getting women to eat more of the low-mercury varieties of fish they are already eating?

Pregnant women deserve clear, simple advice.  The FDA’s “net effect” approach looks at how eating the types of commercial fish Americans do effects heart health and brain development.  It looks at the effects of mercury plus the effects of beneficial nutrients in fish.  This “whole package” approach is novel for the agency, and makes sense because it is what people eat…whole foods.

It should be noted that not everyone takes such issue with the FDA draft report. In fact, if you weed out all the environmental activist form letters that were submitted, you’ll find there are more letters submitted in support of the FDA work than those taking issue with it.

Furthermore, to categorize the FDA’s report as “junk science” suggests that the independent peer reviewers from places like the University of Washington, Harvard School of Public Health, and the Department of Developmental and Behavioral Pediatrics Children's Hospital and Research Center at Oakland have no standards.

What’s more, the mention that EPA’s comments are in response to an analysis by FDA “issued in the waning days of the Bush administration” is not dissimilar to eco-activist talking points I have seen designed to insinuate the FDA’s work was somehow rushed through before the Obama administration took over. What isn’t mentioned in those talking points is that the FDA work took years to complete and was published in the Federal Register on January 21, 2009.  Anything prior to the Obama administration that you may have seen in the media was likely a leaked copy of the unfinished report obtained by EWG that ended up in the papers before the draft was complete.

And as for the warning that the “industry might need to watch its flank” based on a New Jersey lawsuit, perhaps litigation-happy activists should keep in mind two California courts have now ruled that canned tuna does not meet the standard for products that should include warning labels and the California Attorney General has decided, after a pair of defeats, he is not appealing the decision to the California Supreme Court—so at least in the Golden State, it’s case closed.

Gavin Gibbons

National Fisheries Institute