- FDA Declines to Lower its Action Level for Mercury in Fish
- March 12, 2013
- Law Firm: Hyman Phelps McNamara P.C. - Washington Office
FDA recently denied a citizen petition (Docket No. FDA-2011-P-0484) that asked the agency to take numerous actions with respect to mercury in commercial fish. In part, the petition asked FDA to establish an action level, regulatory limit, or tolerance of 0.5 ppm (the current action level is 1.0 ppm) , revise FDA/EPA’s fish consumption advice accordingly, and require posting of that advice at the point-of-sale.
In its response, FDA reviewed evidence bearing on the adverse effects that allegedly can result from exposure to methylmercury, 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 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.