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Media Alerts - Natural Resources Defense Council, Inc. v. U.S. Food & Drug Administration - Second Circuit
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March 17, 2013
  Natural Resources Defense Council, Inc. v. U.S. Food & Drug Administration - Second Circuit
Headline: Second Circuit Upholds NRDC's Standing to Compel FDA to Finalize Regulations of OTC Antimicrobial Chemical Triclosan; Does Not Find Standing as to Chemical Triclocarban.

Area of Law: Constitutional Law/Administrative Law

Issue(s) Presented: Whether the Natural Resources Defense Council possessed Article III standing to bring an action compelling the U.S. Food & Drug Administration to finalize its regulation of two chemicals: triclosan and triclocarban.

Brief Summary: Plaintiff Natural Resources Defense Council ("NRDC") brought suit against the U.S. Food and Drug Administration ("FDA") to compel the FDA to issue regulations pertaining to two chemicals found in over-the-counter antiseptic antimicrobial soaps: triclosan and triclocarban. By federal statute the FDA is tasked with ensuring that a drug does not enter interstate commerce unless it is determined to be "generally recognized as safe and effective ("GRAS/E")." For years, the FDA's determination of triclosan and triclocarban have been pending as a part of the FDA's Over-the-Counter Drug Review Process. The FDA has never issued a finalized regulation on topical antiseptic antimicrobial drugs, despite issuing two draft regulations in 1978 and 1994. On the FDA's motion for summary judgment, the United States District Court for the Southern District of New York found that the NRDC lacked Article III standing to compel the FDA to issue final determinations regarding either chemical.

The Second Circuit vacated the district court's decision with regards to triclosan, but agreed that plaintiff did not possess standing as to the regulation of triclocarban. The Second Circuit found that exposure to triclosan constituted an injury-in-fact, despite the scientific uncertainty as to the chemical's actual risk of harm to human health. Also, the court found that the injury caused by triclosan exposure was "fairly traceable" to the FDA's failure to issue final regulations, rejecting the FDA's claim that exposure to the chemical was self-inflicted and could be avoided by purchasing triclosan-free soap or advocating with employers to purchase triclosan-free soap. The court agreed, however, that the NRDC did not have standing to challenge the FDA with respect to the regulation of the chemical triclocarban because the alleged injury, the development of antibiotic-resistant bacteria, was not sufficiently concrete and particularized to establish injury-in-fact under Article III.

To read the full opinion, please go to:

Significance: The Second Circuit, in a footnote, acknowledges the recent Supreme Court decision in Clapper v. Amnesty Int'l USA, 133 S. Ct. 1138 (2014), but finds that the court's analysis in the instant case remains unaffected by that decision.

Extended Summary: At issue in the instant case was whether the Natural Resources Defense Council ("NRDC") has standing under Article III of the U.S. Constitution to compel the U.S. Food & Drug Administration ("FDA") to finalize its regulation of triclosan and triclocarban, chemicals used in many over-the-counter antiseptic antimicrobial soaps. The Federal Food, Drug, and Cosmetic Act ("FFDCA") prevents any new drug from entering interstate commerce until the FDA has first determined that it is "generally recognized as safe and effective" ("GRAS/E") for the particular use that its product labeling describes. The GRAS/E status of triclosan and triclocarban is currently pending as part of the FDA's "Over-the-Counter Drug Review" process. Under this process the FDA must issue a detailed regulation for each class of over-the-counter drugs (the "monograph") - a process that allows manufacturers to bypass a more cumbersome individualized review process. The monograph that covers triclosan and triclocarban, for all times relevant to this suit, has yet to be finalized; tentative final monographs were issued in 1978 and again in 1994. Under both tentative monographs, triclosan use would be excluded because the FDA was unable to determine that triclosan was GRAS/E. NRDC brought this action in the United States District Court for the Southern District of New York to compel the FDA to finalize its monograph, arguing that the agency had engaged in an unreasonable delay by its failure to regulate potentially dangerous substances. The district court granted the FDA's cross-motion for summary judgment arguing that NRDC lacked standing for failure to establish causation between the FDA's failure to regulate and any purported "injury in fact."

Article III, Section 2 of the U.S. Constitution requires plaintiffs to establish standing before a federal court will entertain their claim. A plaintiff must show that it has suffered an "injury in fact," that the injury is "fairly traceable" to the action being challenged, and that the injury is likely to be "redressed" by a "favorable decision" of the federal court. Organizations like the NRDC can establish standing by showing that at least one of its members would have standing to sue on their own. The Second Circuit found that the NRDC met its burden and established standing with regards to triclosan, but not as to triclocarban.

The court held that NRDC established "injury in fact" with regard to triclosan based upon a showing that one of its members, Diana Owens, a veterinary technician, frequently came into contact with triclosan as a necessary part of her work, and must wash her hands more than fifty times each day with a soap provided by her employer containing triclosan and, accordingly, had a slightly higher risk of ovarian cancer and was concerned about the chemical's hormone-disrupting effect. The court found that the NRDC established a "credible threat of harm despite the uncertainty as to triclosan's definite harmfulness to human beings" and sufficient severity of harm from the evidence that triclosan may contribute to the growth of cancer, is easily absorbable into the bloodstream, and has endocrine-disrupting properties. Although the court noted the lack of evidence showing the precise likelihood that frequent exposure to triclosan caused harm to humans, it reasoned that, when considered in light of the FFDCA's interest in protecting the public from products of unproven safety, the evidence supported a sufficiently concrete and particularized injury under Article III. The Second Circuit rejected the FDA's arguments that the NRDC lacked standing because Owens could avoid exposure by purchasing triclosan-free soap and that any injury would be self-inflicted because she was unable to show that her employer was unwilling to purchase triclosan-free soap, reasoning that the FDA's delay in regulating the chemical still remains a contributing factor to Owens's exposure.

By contrast, the Second Circuit agreed with the district court that the NRDC failed to establish that its members suffered any "injury in fact" by being directly exposed to triclocarban. The court rejected as insufficient and too remote the NRDC's argument that its members suffered an "injury in fact" because the general proliferation of antiseptic antimicrobial soaps containing triclocarban could lead to the development of antibiotic-resistant bacteria.

To read the full opinion, please go to:

Panel: Circuit Judges Pooler and Lynch; District Judge Cogan.

Argument: 05/14/2012

Date of Issued Opinion: 03/15/2013

Docket Number: 11-422-cv

Decided: Vacated and Remanded to the United States District Court for the Southern District of New York.

Case Alert Author: Benjamin F. Krolikowski

Counsel: Aaron S. Colangelo, National Resources Defense Council (Mitchell S. Bernard, Nancy Sherman Marks, Vivian H.W. Wang, National Resources Defense Council, New York, N.Y., on the brief), Washington, D.C., for Plaintiff-Appellant; John D. Clopper, Assistant United States Attorney for the Southern District of New York (Preet Bharara, United States Attorney, Sarah S. Normand, Assistant United States Attorney, on the brief), New York, N.Y., for Defendants-Appellees; Alison M. Zieve, Public Citizen Litigation Group (Scott L. Nelson, on the brief), Washington, D.C., for Amici Curiae Public Citizen, Inc., Asian American Legal Defense Fund, Bronx Health Link, Inc., Empire State Consumer Project, Equal Justice Society, Healthy Schools Network, Institute for Health and Environment at University at Albany, National Campaign to Restore Civil Rights, New York City Environmental Justice Alliance, New York Committee for Occupational Safety and Health, New York Lawyers for the Public Interest, Inc., and Center for Civil Rights, UNC School of Law, in support of Plaintiff-Appellant.

Author of Opinion: Circuit Judge Pooler.

Supervisor: Professor Elyse Diamond Moskowitz

    Posted By: Elyse Diamond @ 03/17/2013 05:23 PM     2nd Circuit  

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