NRDC v. U.S. Food & Drug Administration

Friday, March 22, 2013

NRDC v. U.S. Food & Drug Administration

Mar 21: In the U.S. Court of Appeals, Second Circuit, Case No. 11-422. Appealed from the U.S. District Court for the Southern District of New York. The Appeals Court explains that at issue is whether NRDC has standing under Article III of the U.S. Constitution to bring this action to compel FDA to finalize its regulation of triclosan and triclocarban, two chemicals used in over-the-counter antiseptic antimicrobial soap.

The Appeals Court holds that "NRDC has presented evidence of standing sufficient to withstand summary judgment as to the regulation of triclosan, but not as to the regulation of triclocarban. As to triclosan, standing may be based on exposure to a potentially dangerous product, and NRDC's evidence establishes that triclosan is potentially dangerous and that at least one of its members is frequently exposed to triclosan-containing soap. As to triclocarban, NRDC presented no evidence of members' direct exposure but relied on evidence that the proliferation of triclocarban may contribute to the development of antibiotic-resistant bacteria. This evidence is insufficiently particular to support standing. . . Accordingly, we vacate the district court's grant of summary judgment and remand for further proceedings."

The Appeals Court indicates that, "The district court granted summary judgment in favor of FDA and dismissed the suit for lack of standing. Assuming without deciding that exposure to triclosan was cognizable as an injury for standing purposes, the district court concluded that NRDC lacked standing because its members could avoid their workplace exposure to triclosan by purchasing antimicrobial-free soap for use at work."

The Appeals Court said, "At issue is whether the potential avoidability of triclosan exposure at the workplace -- either by purchasing triclosan-free soap or by advocating with employers to supply triclosan-free soap -- renders the exposure "self-inflicted" so as to vitiate the causal link between FDA's alleged regulatory delay and NRDC members' triclosan exposure. We hold that neither the availability of triclosan-free soap for purchase nor the possibility that NRDC members' employers might be willing to supply triclosan-free soap prevents NRDC from establishing that the triclosan exposure is fairly traceable to FDA's alleged unreasonable delay in regulating triclosan.

"The inquiry as to triclocarban requires us to determine whether the existence of a chemical that may contribute to the development of antimicrobial- or antibiotic-resistant bacteria satisfies the injury-in-fact requirement. We hold that it does not. . . NRDC provided no evidence that its members were directly exposed to triclocarban. Its theory of standing as to triclocarban thus cannot be that, under Baur, its members are exposed to a potentially dangerous substance. Instead, NRDC argues that its members suffer injury in fact due to FDA's alleged delay in finalizing its regulation of triclocarban because the proliferation of triclocarban, together with other antimicrobial antiseptic chemicals, may lead to the development of antibiotic-resistant bacteria."

Access the complete opinion (click here). [#Toxics, #CA2]

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