FDA responeIn 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.
