FDA rejects petition to change methylmercury standard in seafood
(13.03.2013)
FDA recently denied a citizen petition that asked the agency to take numerous actions with respect to mercury in commercial fish. The requested tolerance limit would bring FDA's fish-related standards in harmony with EPA's stricter criteria for mercury in water.
The petition
GotMercury.org, an arm of the Turtle Island Restoration Network, along with the Center for Biological Diversity and the Stanford University Environmental Law Clinic, filed a citizen's petition (Docket No. FDA-2011-P-0484) on June 20, 2011, asking FDA to establish a stricter regulatory limit for mercury in commercial fish.
In more detail, the petition asked FDA to take the following actions:
Replacing the FDA action level of 1.0 parts per million (ppm) mercury in fish with an action level, regulatory limit, or tolerance no greater than 0.5 ppm mercury in fish in order "to protect women of childbearing age, pregnant and nursing women, children and the most vulnerable populations;"
Enforcing the new action level, regulatory limit, or tolerance and/or prohibit the sale of seafood that contains mercury concentrations that exceed it;
Revising the fish consumption advice issued jointly by FDA and the U.S. Environmental Protection Agency (EPA) in 2004 (FD A!EP A fish consumption advice) to reflect any new 0.5 ppm level;
Requiring that the fish consumption· advice be posted at point-of-sale locations or on labels offish "known to be high in methylmercury;"
Conducting "regular, widespread" testing of commercial seafood for mercury levels and make the results public;
Revising the FDA concentrations in fish by conducting new mercury analyses of each fish species listed in the FDA database ("Mercury Levels in Commercial Fish and Shellfish"); and ·
Modifying FDA's guidance to seafood processors (the Fish and Fishery Products Hazards and Controls Guidance) by advising them how they can control for methylmercury.
FDA respone In its response, FDA reviewed evidence bearing on the adverse effects that allegedly can result from exposure to methylmercury in the absence of extreme saefood consumption, including neurological effects, coronary heart disease, kidney failure, and genetic damage. For certain adverse effects, the petition included no evidence to support its assertions, so FDA relied on evidence of which the agency is aware.
FDA noted that 99.9 percent of adults in the National Health and Nutrition Examination Survey (NHANES) conducted by the Centers for Disease Control and Prevention (CDC) have been exposed to methylmercury below the Acceptable Daily Intake Level ("ADI"), which includes a 10-fold margin of safety. FDA has therefore seen no need to enforce the current action level to reduce exposure to methylmercury.
FDA then reviewed relevant case studies, published studies, and information provided in the petition. FDA concluded that the petition failed to provide sufficient evidence that commercial fish with more than 0.5 ppm of mercury pose a reasonable possibility of injury to the general population or to susceptible subpopulations (e.g., young children). In addition, FDA noted that there is substantial evidence that consumption of fish is associated with neurodevelopmental and other benefits, even taking into account potential exposure to methylmercury.
FDA also declined to require posting of the FDA/EPA fish consumption advisory at the point-of-sale because the petition did not provide a basis for a determination that such information is “material” within the meaning of section 201(n) of the Federal Food, Drug, and Cosmetic Act.
FDA further argues that the better approach to risk management- and the one that is being taken- is targeted recommendations on how to obtain benefits that fish can provide to the fetus and young children while minimizing any effects from methylmercury.
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