Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin.

• Decision Date: 21 March 2013
• Docket Number: Docket No. 11–422–cv.
• Citation: 710 F.3d 71
• Parties: NATURAL RESOURCES DEFENSE COUNCIL, INC., Plaintiff–Appellant, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Kathleen Sebelius, in her Official Capacity as Secretary, United States Department of Health and Human Services, Margaret Hamburg, in her Official Capacity as Commissioner, United States Food And Drug Administration, Defendants–Appellees.
• Court: U.S. Court of Appeals — Second Circuit

710 F.3d 71

NATURAL RESOURCES DEFENSE COUNCIL, INC., Plaintiff–Appellant,

v.UNITED STATES FOOD AND DRUG ADMINISTRATION, Kathleen Sebelius, in her Official Capacity as Secretary, United States Department of Health and Human Services, Margaret Hamburg, in her Official Capacity as Commissioner, United States Food And Drug Administration, Defendants–Appellees.^*

Docket No. 11–422–cv.

United States Court of Appeals, Second Circuit.

Argued: May 14, 2012.

Decided: March 15, 2013.

Amended: March 21, 2013.

Aaron S. Colangelo, Natural Resources Defense Council (Mitchell S. Bernard, Nancy Sharman Marks, Vivian H.W. Wang, Natural 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.

Before: POOLER, LYNCH, Circuit Judges, COGAN, District Judge. ^**

POOLER, Circuit Judge:

Plaintiff–Appellant Natural Resources Defense Council (“NRDC”) appeals from a judgment of the United States District Court for the Southern District of New York (Hellerstein, J.), granting summary judgment to defendants the Food and Drug Administration (“FDA”), Kathleen Sebelius, and Margaret Hamburg (collectively, the “government”). 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.

We hold 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.¹ NRDC has presented sufficient evidence of standing as to triclosan because 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 does not establish an injury sufficiently particularized to satisfy the injury-in-fact requirement of Article III standing. Accordingly, we vacate the district court's grant of summary judgment and remand for further proceedings.

BACKGROUND

I. Regulatory Framework

This case concerns FDA's regulation of over-the-counter (“OTC”) topical antiseptic antimicrobial chemicals. Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FFDCA”), a new drug may not enter interstate commerce unless FDA determines that it is generally recognized as safe and effective (“GRAS/E”) for the particular use described in its product labeling. See21 U.S.C. § 321(p)(1) (defining a “new drug” as one that “is not generally recognized, among experts ... as safe and effective for use under the conditions” noted in the drug's labeling); id. § 355(a) (prohibiting a “new drug” from entering interstate commerce without FDA approval).

Triclosan and triclocarban are undisputedly “drugs” within the meaning of the FFDCA. FDA's determination of triclosan's and triclocarban's GRAS/E status is pending as part of FDA's comprehensive “Over–the–Counter Drug Review” process (“OTC Drug Review”). Commenced in 1972, the OTC Drug Review established FDA's “monograph” system for regulating over-the-counter drugs. See21 C.F.R. § 330.10; 37 Fed. Reg. 9464 (May 11, 1972). While FDA must generally approve drugs as GRAS/E individually, the monograph system allows manufacturers to bypass individualized review. See21 U.S.C. § 355; 21 C.F.R. § 330.10. Under this system, FDA issues a detailed regulation—a “monograph”—for each therapeutic class of OTC drug products. Like a recipe, each monograph sets out the FDA-approved active ingredients for a given therapeutic class of OTC drugs and provides the conditions under which each active ingredient is GRAS/E. FDA excludes from its monographs any active ingredients or uses of active ingredients that it has determined either not to be GRAS/E or for which there is insufficient data to confirm whether they are GRAS/E. Manufacturers desiring to market OTC drugs that are excluded from the monograph may not do so without obtaining individualized FDA approval.

Through the OTC Drug Review, FDA determines the GRAS/E status of each OTC drug product and issues monographs for each category. According to FDA's evidence submitted to the district court, as of December 1, 2010, FDA had published 125 final rules through the OTC Drug Review, including final monographs and amended final monographs. The monograph for topical antiseptic antimicrobial drugs, in which triclosan and triclocarban are to be included, has not yet been finalized. In the exercise of its enforcement discretion, however, FDA permits drugs whose monograph is still pending under the OTC Review process to stay on the market, provided that FDA has not determined that the drug is “a potential health hazard.” FDA Compliance Policy Guide § 450.200; 68 Fed. Reg. 75585, 75590–91 (Dec. 31, 2003).

Over the course of the OTC Drug Review, FDA has issued two tentative final monographs for topical antiseptic antimicrobials,once in 1978 and again in 1994, but has not finalized either monograph. See43 Fed. Reg. 1210 (Jan. 6, 1978); 59 Fed. Reg. 31402 (June 17, 1994); Ganley Declaration ¶ 48. Both tentative monographs would have excluded triclosan because FDA had not determined that triclosan was GRAS/E for any use at the time it issued the tentative monographs.

II. Proceedings Before the District Court

NRDC brings this action under the Administrative Procedure Act, 5 U.S.C. § 500 et seq. (“APA”), which authorizes those “adversely affected or aggrieved” by an agency's inaction to file suit to compel an agency to take action “unreasonably delayed.” 5 U.S.C. §§ 702, 706(1).² NRDC alleges that FDA is unreasonably and unlawfully failing to regulate potentially dangerous substances, triclosan and triclocarban, and seeks to compel FDA to finalize its regulation of triclosan and triclocarban by issuing the final monograph regulating topical antimicrobial drug products.

Before the district court, NRDC moved for summary judgment on the merits, and the government cross-moved for summary judgment on the ground that NRDC lacked standing.

A. NRDC's Evidence of Standing

As evidence of standing, NRDC submitted declarations executed by two of its members and documents discussing the risks posed by triclosan and triclocarban.

1. NRDC Member Declarations

NRDC submitted the declarations of its members Ms. Diana Owens, a veterinary technician (“Owens Declaration”), and Dr. Megan Schwarzman, a physician, describing their exposure to triclosan in their places of work.

In her declaration, Diana Owens avers that she is exposed to triclosan in her work as a veterinary technician at an animal clinic, where she has worked for nearly twenty years. As a necessary part of her work, she washes her hands more than fifty times in the course of a single work day. The soap that she uses is that provided by the clinic—an antibacterial soap that contains triclosan. The clinic also uses triclosan-containing dish soap that Owens uses to clean animals' food and water dishes, one of Owens's job duties.

Owens avers that she has a slightly increased risk of ovarian cancer and is concerned about the hormone-disrupting effects of triclosan. She also expresses general concern regarding triclosan's potential to increase antibiotic resistance. Owens has attempted to raise the issue of triclosan's dangers with the clinic owner, who is responsible for providing the soap clinic employees use in their work and purchases the soap from the wholesale store, Sam's Club. Owens reports that she has “discussed [her] concern about triclosan exposure with the clinic owner and with [her] coworkers,” but to no avail: “[t]hey listen but because they do not really know about the health risks, nothing is done to limit our exposure.” Beyond these discussions, Owens does not describe having taken further action to have the soaps changed at the clinic. She explains that she does not “feel comfortable asking the clinic owner, who is [her] supervisor, to spend extra time looking at the labels on soap bottles or to spend more money to purchase natural products.” She does not “want to be the employee who is pushy and creates problems.”

Because we conclude, see Discussion infra, that the Owens Declaration is sufficient to establish NRDC's standing, we do not discuss the declaration of Dr. Schwarzman. We observe, however, that while NRDC seeks to compel FDA to finalize its regulation of both triclosan and triclocarban, its member declarations establish the members' direct exposure only to triclosan; NRDC submitted no evidence that any of its members is directly exposed to triclocarban, and instead relies on evidence that its members are injured by triclocarban's potential, along with other antiseptic antimicrobial chemicals, to hasten the development of antibiotic-resistant bacteria.

2. Evidence of Risks posed by Triclosan and Triclocarban

...