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.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.