The Natural Resources Defense Council, Inc. (NRDC), a non-profit advocacy organization, has filed a complaint for declaratory and injunctive relief against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), seeking an order compelling FDA to issue a final response to NRDC’s October 2008 petition calling on the agency to prohibit the use of bisphenol A (BPA) in food packaging and other food-contact materials. NRDC, Inc. v. HHS, No. 11-5801 (U.S. Dist. Ct., S.D.N.Y., filed August 19, 2011). In June 2011, the D.C. Circuit Court of Appeals apparently dismissed a similar complaint, agreeing with FDA that it had been filed in the wrong court. Additional information about that complaint appears in Issue 356 of this Update.
According to the new complaint, the Food, Drug, and Cosmetic Act requires FDA to respond to petitions like the one NRDC filed “within 90 days.” Yet, “ [m]ore than one thousand days have now passed without an agency response. In light of the harms associated with widespread exposure to BPA in food, FDA’s delay in responding to the petition is unreasonable and violates the Administrative Procedure Act (APA), and the Food Act.” According to NRDC, BPA is “a high production volume chemical, with over six billion pounds produced globally and over two billion pounds produced in the United States each year.” Claiming that the chemical is a food additive which leaches from food containers into food and that a 2007 National Institutes of Health report concluded, “BPA exposure at current levels presents a significant risk to human health,” NRDC alleges that FDA underestimates the levels of BPA to which adults are exposed. The complaint also outlines the chemical’s purported endocrine-disrupting and reproductive effects.
Contending that FDA’s failure to respond to its petition constitutes an unreasonable delay under the APA, NRDC asks the court to make a declaration to that effect, compel the agency to respond and award NRDC is costs and attorney’s fees. See The New York Times, June 17, 2011.