The Second Circuit Court of Appeals has determined that the Natural Resources Defense Council (NRDC) has standing to bring an action against the Food and Drug Administration (FDA) seeking to compel the agency to finalize its regulation of triclosan, a chemical used in over-the-counter antiseptic antimicrobial soap. NRDC v. Sebelius, No. 11-422 (2d Cir., decided March 15, 2013). Additional information about the case appears in the May 24, 2012, issue of this Report. So ruling, the court also found that NRDC lacked standing to compel action on a different but related chemical—triclocarban—because it lacked evidence of members’ direct exposure to the chemical. The Second Circuit reversed the district court’s grant of summary judgment to FDA and remanded the matter for further proceedings.
According to the court, FDA has not yet finalized monographs on either chemical, a step in the process of determining the generally recognized as safe and effective (GRAS/E) status for over-the-counter drugs. FDA has allowed these chemicals to remain on the market despite issuing tentative monographs that would have excluded triclosan because the agency had not determined that the chemical was GRAS/E for any use when the monographs were issued in 1978 and 1994.
Among other matters, the court determined that NRDC had standing because one of its members, a veterinary technician, washes her hands more than 50 times each day using an antibacterial soap supplied by her employer. She also washes animal food and water dishes with a dish soap that also contains triclosan. She is concerned about the hormone-disrupting effects of the chemical and about its potential to increase antibiotic resistance. Her employer and co-workers failed to acknowledge her concerns so “nothing is done to limit our exposure.” She also indicated that she did not take further action to change soaps at the clinic because she was uncomfortable imposing time and expense burdens on her employer to find and purchase soaps without the chemical. While the government argued that her exposure was self-inflicted and thus she had no injury-in-fact because she could buy her own chemical-free soap to use at the clinic, the court said that the expense to her of providing her own soap would constitute an injury-in-fact for Article III standing.
The court also agreed that NRDC had shown sufficient evidence of risk from triclosan exposure, including an expert declaration, an FDA letter responding to Rep. Edward Markey’s (D-Mass.) concerns about the chemicals and an FDA consumer notice about triclosan. According to the court, these documents established a credible threat from exposure “notwithstanding the uncertainty as to triclosan’s harmfulness to humans. … Here, FDA has stated that triclosan presents ‘valid concerns,’ and FDA has nominated triclosan for a toxicology study, including a study of its carcinogenicity. Further, the record evidence shows that FDA admits that it has insufficient data on triclosan’s long-term health effects and that FDA itself is concerned about the long-term effects of triclosan exposure.”