Last week, the Second Circuit released an opinion in a case brought by the National Resources Defense Counsel (NRDC) against the FDA seeking to compel the FDA to finalize regulation of chemicals contained in over-the-counter antiseptic antimicrobial soap. In reviewing the lower court’s grant of summary judgment to the FDA on grounds that the NRDC lacked standing, the Second Circuit held that standing of an organization like the NRDC to bring this type of suit hinges on whether organization members have a significant risk of injury from the chemical for which regulation is being sought. Such risk can be found where the member has proven definite exposure to the chemical and there are serious scientific arguments to suggest it may be harmful, even if its harm has yet to be proven. In this case, since the NRDC was able to establish at least one of its members’ direct exposure to one of the chemicals – but not the other - the Second Circuit reversed the lower court’s decision and remanded the case with respect to the regulation of that chemical only. On remand, the lower court will still have to determine whether the alleged possible medical risks posed by the chemical are sufficient to compel FDA action.
At issue in this case is the FDA’s regulation of the chemicals triclosan and triclocarban, antimicrobial chemicals that are found in soaps sometimes used in medical settings and elsewhere and which are classified as drugs under the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the FFDCA, the FDA is therefore required to issue a finding as to whether these chemicals are safe and effective for their intended use before they can enter interstate commerce. The FDA’s review on this matter is currently pending under the FDA’s Over-The-Counter Drug Review process, a process which dictates that the FDA will consider all antimicrobial agents together at one time. Meanwhile, the FDA has determined that triclosan and triclocarban may remain on the market until that review is finalized since the FDA has not as of now determined any potential health hazard.
The NRDC, an environmental action group, filed this lawsuit under the federal Administrative Procedure Act (APA) which allows for private parties that are adversely affected by a federal agency’s inaction to compel that agency to take action. The NRDC”s position is that the FDA has failed to take action to properly regulate triclosan and triclocarban, and the NRDC therefore seeks to compel the FDA to finalize its Over-The-Counter Drug Review for antimicrobial products. The FDA argued in turn that the NRDC could not bring suit because under Article III of the Constitution there is no case or controversy between any of its members and the FDA with respect to the regulation of triclosan and triclocarban. The lower court agreed, holding that because NRDC members could voluntarily avoid triclosan and triclocarban exposure, the NRDC did not have standing to bring this suit.
Concerns about triclosan and triclocarban stem from the fact that they are allegedly endocrine-disruptors and therefore may, among other things, adversely affect the reproductive system, contribute to the onset of hormone-dependant cancers, or potentially cause infertility in people who are exposed. The NRDC argued that it has standing to bring suit regarding triclosan because its members have been directly exposed (citing the declaration of an NRDC member who washes her hands with this soap several times a day in her work at a veterinary clinic). The NRDC simultaneously argued that its standing with respect to regulation of triclocarban stems from the fact that its existence on the market has the potential to increase the presence of antibiotic-resistant bacteria in the general population, despite the fact that no NRDC members have alleged direct exposure to this chemical.
The Second Circuit, in reversing the lower court with respect to triclosan, held that NRDC members sufficiently established – as required under Article III – evidence that they were both injured-in-fact by triclosan and that their injury is traceable to the FDA’s conduct. The Second Circuit opinion acknowledges both that there is scientific uncertainty about triclosan’s harmfulness and that NRDC members could potentially use triclosan-free soap, but did not find these facts to be barriers to meeting the elements of Article III standing: injury-in-fact for purposes of such standing is found from plaintiffs’ exposure to the triclosan coupled with expert testimony that shows triclosan may cause serious medical risk; causation for purposes of such standing is found in triclosan’s availability on the market alone. Injury-in-fact was not found with respect to triclocarban, at least for NRDC plaintiffs, however, because rather than alleging an injury resulting from direct exposure, plaintiffs’ alleged injuries require an intervening occurence between triclocarban’s presence on the market and its potential affect on plaintiffs (the spread of antibiotic-resistant bacteria).
This is not the first case to find injury-in-fact, for purposes of standing to bring an APA action, to result from exposure to a harmful substance even without any medically adverse consequences to the plaintiff; in fact the Second Circuit cites an opinion it issued in 2003 in the case of Baur v. Veneman, 352 F.3d 625, finding injury-in-fact where a plaintiff was potentially exposed to a known toxin. The NRDC case is significant because of its holding that definite exposure to a potentially harmful substance is an injury equal to potential exposure to a proven dangerous substance; while the Second Circuit stated as much in its 2003 Baur holding, this recent NRDC case presents that actual fact pattern and affirms the court’s willingness to apply this rationale. This case sets a concrete example of the potential for APA suits to proceed that seek to compel increased regulation even of products for which current scientific studies of their hazards are inconclusive. For regulatory agencies as well as the manufacturers of regulated products, this case then sounds a warning alarm. At the same time, this case draws a distinction even among scientifically unproven harms: direct exposure to a product which is a potential endocrine-disruptor may give rise to APA standing, while indirect exposure to a product that allegedly leads to the potential proliferation of antibiotic-resistant bacteria will not. So while this case may foretell of APA actions involving products that are not yet proven harmful, the alleged route of the harm is critical in determining whether there is risk of potential suit and if so, by whom.