FDA Denies Citizen Petition Related to Adverse Effects of Exposure to Methylmercury in Commercial Fish

Based on the Food and Drug Administration’s (FDA’s) review of evidence bearing on the adverse effects that allegedly can result from exposure to methylmercury found in commercially sold seafood, including neurological effects, coronary heart disease, kidney failure, and genetic damage, the FDA denied the citizen petition (GotMercury (Mills Legal and Environmental Law Clinic) (Docket No. FDA-2011-P-0484)) because the petition included no evidence to support its assertions for certain adverse effects and the FDA relied on evidence of which it is aware, according to an FDA blog post written by Ricardo Carvajal, attorney with Hyman, Phelps, & McNamara, PC.

The petition asked the FDA to: (1) establish an action level, regulatory limit, or tolerance of 0.5 ppm (the current action level is 1.0 ppm); (2) enforce the new action level, regulatory limit, or tolerance and/or prohibit the sale of seafood that contains mercury concentrations that exceed it; (3) revise the fish consumption advice issued jointly by FDA and the U.S. Environmental Protection Agency (EPA) in 2004 to reflect any new 0.5 ppm level; (4) require that the fish consumption advice be posted at point-of-sale locations or on labels of fish “known to be high in methylmercury; (5) conduct “regular, widespread” testing of commercial seafood for mercury levels and make the results public; (6) revise the FDA concentrations in fish by conducting new mercury analyses of each fish species listed in the FDA database; and (7) modify FDA’s guidance to seafood processors by advising them how they can control for methylmercury.

The FDA concluded that the petition did not provide sufficient data or information for FDA to take the actions the petition requested such as specifics related to actual injuries within the general population or estimates of risk, to persuade FDA that commercial fish with more than 0.5 ppm of mercury pose a reasonable possibility of injury and, therefore, are adulterated under sec. 402(a)(l) of the Food, Drug & Cosmetic (FD&C) Act (21 U.S.C. sec. 342(a)(1)), or that it is necessary or appropriate to establish a tolerance of 0.5 ppm for mercury in commercial fish for the protection of the public health under sec. 406 of the FD&C Act (21 U.S.C. sec. 346). Furthermore, the petition failed to provide sufficient data or information, such as specifics relating to actual injuries within certain susceptible subpopulations or estimates of risk, to persuade FDA that commercial fish with more than 0.5 ppm of mercury pose a reasonable possibility of injury to these susceptible subpopulations. Therefore, the FDA declined to set an action level, regulatory limit, or tolerance no greater than 0.5 ppm for mercury in commercial fish. 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 sec. 201(n) of the FD&C Act (21 U.S.C. sec. 321(n)).