The Food and Drug Administration (FDA) recently denied a citizen petition seeking to replace “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.’” Filed by the Center for Biological Diversity and Got Mercury, the petition also asked FDA, among other things, to (i) enforce the new limit “and/or prohibit the sale of seafood that contains mercury concentrations that exceed it,” (ii) require retailers to post point-of-sale warnings or otherwise label fish “known to be high in methylmercury,” and (iii) conduct “regular, widespread” testing for mercury and publicize the results.
In denying the petition, FDA noted the agency is authorized “but not required” to set a tolerance, action level or regulatory limit for methylmercury in fish. To this end, FDA argued that establishing a regulatory limit or action level would require it to establish that “fish containing 0.5 ppm or more mercury are adulterated,” even though “the mere presence of an added poisonous or deleterious substance does not render food adulterated under section 401(a)(1)” of the Food, Drug, and Cosmetic Act. Moreover, even if an action level has been exceeded, the agency “has the burden of establishing de novo in an enforcement proceeding that the food was adulterated,” contrary to the petition’s suggestion that an action level is enforceable “simply by demonstrating that is has been exceeded… or that it is a rule.”
FDA also found that the evidence presented by the petitioners as to the health effects of methylmercury on both the general population and specific subpopulations did not justify revising the current action level of 1.0 ppm. “Your 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 populations,” concludes the agency. “In our view, 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.” Additional details about Got Mercury’s campaign appear in Issue 378 of this Update.