A lawsuit filed today in federal district court against the U.S. Food and Drug Administration (FDA) is the next step in an ongoing campaign by consumer protection and environmental advocates to demand the Agency give consumers vital health information about toxic mercury in seafood. Earthjustice, on behalf of the Center for Science in the Public Interest and the Mercury Policy Project, is suing the FDA for failing to respond to a July 2011 petition in which the Mercury Policy Project asked the FDA to give consumers “clear, accurate and accessible information about toxic mercury in seafood.” The FDA’s current advice on seafood was published in 2004 and is seen by many in the health and science communities as being out-of-step with the best available science.
Clarify and Better Communicate Federal Seafood Advice
The 2011 petition, which the FDA failed to acknowledge within the required 180 days, asked the FDA Commissioner to initiate formal rulemaking with respect to point-of-sale labeling on seafood products advising the consumer of the relative amounts of mercury in seafood. “The purpose of this rulemaking,” said Michael Bender, director of the Mercury Policy Project, “would be to clarify and better communicate federal seafood advice to women of childbearing age and parents of children.”
“FDA’s failure to respond to our petition is frustrating and disappointing,” said Earthjustice attorney Summer Kupau-Odo. “Citizens expect that the public health agency charged with ensuring that food is safe and properly labeled will respond to their valid food safety concerns in a timely manner, especially when the health of some of the most vulnerable members of our community—infants and children—is at risk.”
FDA officials declined to comment on the lawsuit at this time.
Sources of Mercury Pollution and Methylmercury Exposure
While mercury naturally exists in the environment, human activities such as coal-fired power plants and artisanal gold mining have greatly increased the levels of mercury released into the environment. Concentrations of mercury in the upper 100 meters of the ocean have increased dramatically over the past 500 years and have seen a two-fold increase over the last century. The result is widespread mercury pollution that poses the greatest health risk to humans through the consumption of fish.
Once in aquatic ecosystems, mercury transforms into methylmercury and some of it then makes its way into the food web, moving from phytoplankton to zooplankton and on up the food chain through forage fishes and increasingly larger predators. Methylmercury concentrations in some apex predators like sharks and tuna can be 100 million times greater than in the water.
Human health risks from exposure to methylmercury are linked to neurological defects and impaired fetal and infant growth, as well as cardiovascular disease, impaired cognitive and nervous system functioning, learning disabilities, and lowered IQ. Because of emerging science regarding the health concerns associated with exposure to methylmercury, in the past 40 years federal agencies have reduced the daily-recommended intake of mercury from close to 100 micrograms to 0.1 microgram per kilogram of body weight. Since 2004, the year the FDA published the current federal advice on consuming seafood, a greater understanding of the serious risks to human health from even low levels of methylmercury has rendered the FDA advice out-of-date and insufficient, especially insofar as woman of reproductive age, children and other sensitive populations are concerned.
Updated Advice “Urgently Needed”
“The public—and especially at-risk groups such as pregnant women and heavy fish eaters—urgently need updated information,” said Bender. “It is unconscionable that FDA continues to drag its feet when the latest science indicates a far greater methylmercury exposure risk than when the Agency developed its fish consumption advisory in 2004.”
Bender says the lawsuit is necessary because all other efforts have been exhausted. “Large segments of the U.S. population—including children, pregnant women and women of childbearing age, in particular—have elevated mercury levels above the levels recommended for fetal and child health,” he said, adding that these figures are even higher in coastal regions and among groups such as African-Americans and Asians, the affluent and those in the fishing industry or who rely on subsistence or recreational fishing. “Moreover, most individuals in the U.S. do not know how to best minimize the risk to their families and unborn children from exposure to methlymercury.”
Beyond the Earthjustice Lawsuit
Concerns regarding mercury exposure are nothing new, but the engagement in the issue by scientists, policy makers and advocacy groups has increased. A separate lawsuit was filed against the FDA last week regarding dental amalgam mercury, and, late last month, a federal court in New York refused to dismiss claims alleging Bumble Bee Foods is strictly liable for and was negligent in failing to warn about the mercury in its products. In the latter case (Porrazzo v. Bumble Bee Foods, LLC), in which Bumble Bee argued the FDA does not require warnings about methylmercury on seafood labels, the court said, “the FDA’s decision not to adopt a warning requirement does nothing to absolve defendants of liability if they breached their common law duty to warn. To hold otherwise would entirely vitiate the failure to warn doctrine, rendering proof of such claim impossible unless a federal agency specifically mandated the missing warning.”
On a global scale, the United States’ actions appear to indicate an understanding of the risks associated with, as well as the need for reduction in, mercury pollution. Last fall, the U.S. was the first country to sign the Minamata Convention on Mercury. The convention was named in honor of Minamata, Japan, where more than 2000 people were poisoned by mercury secondary to methylmercury released in industrial wastewater by a chemical factory between 1932 and 1968.
“On [the issue of mercury],” says Bender, “it appears that our government is speaking out of both sides of its mouth. On the one hand, recognizing the importance of reducing mercury exposure risks to Americans, the U.S. recently became the first country to ratify a new global treaty on mercury. However, here at home, FDA continues to drag its feet on effectively warning pregnant women and heavy fish eaters, even though the latest science indicates a far greater risk than when the current fish advisory was issued in 2004.”
There is little doubt the fishing industry, which already has an antagonistic relationship with many consumer protection and environmental advocates, will be strongly against pressure put on the FDA to issue more conservative advice when it comes to eating seafood. Hopefully the science will remain at the center of the debate, and hopefully fishers and fisher communities will not become pawns in a larger power struggle.
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