11-422
Natural Resources Defense Council, Inc. v. U.S. Food and Drug Administration


                                      UNITED STATES COURT OF APPEALS
                                          FOR THE SECOND CIRCUIT
                                            ____________________

                                                       August Term, 2011

(Argued: May 14, 2012                                                          Decided: March 15, 2013)

                                                     Docket No. 11-422-cv

                                                   ____________________

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.*

                                                   ____________________

Before: POOLER, LYNCH, Circuit Judges, COGAN, District 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. At issue is whether NRDC has standing under

*
    The Clerk of the Court is directed to amend the caption as set out above.
**
 The Honorable Brian M. Cogan, United States District Court for the Eastern District of New
York, sitting by designation.
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. 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.

       Vacated and remanded.

____________________

                               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.


                                                 2
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.




1
  We note our receipt of Fed. R. Civ. P. 28(j) letters dated March 11, 2013, and March 12, 2013,
from the Appellees and the Appellant, respectively, alerting us to the decision in Clapper v.
Amnesty Int’l USA, 133 S. Ct. 1138 (2013). The decision in Clapper does not alter the analysis
here.
                                                  3
                                        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. See 21 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. See 21 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. See 21 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

                                                 4
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. See 43 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).1
1
 See 5 U.S.C. § 555(b) (requiring an agency to “proceed to conclude a matter presented to it”
within a reasonable time); 5 U.S.C. § 702 (“A person . . . adversely affected or aggrieved by
agency action . . . is entitled to judicial review thereof.”); 5 U.S.C. § 551(13) (defining “agency
action” to include “failure to act”); 5 U.S.C. § 701(a)(2) (precluding judicial review of agency
action “committed to agency discretion by law”).
                                                     5
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

                                                 6
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

       NRDC principally relied on three documents to evidence the risks posed by triclosan and

triclocarban: (1) an expert declaration by Sarah Janssen, M.D., Ph.D., M.P.H. (“Janssen

Declaration”), (2) a letter from FDA to Representative Edward Markey, then-Chairman of the

House Subcommittee on Energy and Environment, regarding regulation of topical antiseptic

drug products (“Markey Letter”), and (3) a consumer notice about triclosan posted by FDA on its

web site (“FDA Consumer Notice”).

                                                 7
                        a.      Janssen Declaration

        Sarah Janssen, M.D., Ph.D., M.P.H., is a doctor, the author of scholarly articles and book

chapters on the subject of endocrine-disrupting chemicals, and an expert on effects of endocrine-

disrupting chemicals on human health. According to her declaration, triclosan is rapidly

absorbed into the human bloodstream, which means that it “bypass[es] liver metabolism, . . .

[and] therefore ha[s] a greater potential to cause toxicity to many organs in the body.”         The

declaration primarily addresses triclosan’s association with endocrine disruption. Janssen

explains that triclosan is associated “with a unique type of endocrine disruption.” Endocrine

disruption can affect the reproductive system. In particular, recent studies on female rats show

that triclosan interacts with estrogen to increase uterine weight at doses of triclosan that would

not have an effect if not for the interaction with estrogen. This potential for triclosan to amplify

hormone action raises concerns that triclosan may “stimulate the growth of hormone-dependent

cancers.” In addition, triclosan can lead to abnormal menstrual cycles in women and infertility

in both women and men. Moreover, even low-dose exposure to triclosan interferes with the

activity of hormones essential to the normal growth and function of reproductive systems, and

animal studies have shown low doses to interfere with sex hormone synthesis.

        In addition to triclosan’s endocrine-disrupting properties, Janssen notes that older studies

previously reviewed in the FDA OTC Drug Review linked triclosan with organ damage, brain

and spleen changes, testicular damage, liver damage, and the blood disorder,

methemoglobinemia. Finally, Janssen avers that “[n]umerous studies have suggested that . . .

triclosan fosters antibiotic resistance in bacteria,” and that “[a]t least one study has . . . associated

triclocarban with promoting such resistance.”



                                                   8
       Overall, Janssen opines that “[u]se of over-the-counter topical antimicrobial products

containing triclosan and triclocarban contributes to individuals’ total body burden[2] and may be

both significant and harmful.” She continues, “The best available science indicates that . . .

exposures [to triclosan and triclocarban], especially during critical periods of development, may

harm human health.” Thus, “[i]n [Janssen’s] scientific opinion, delaying finalization of the

[antimicrobial antiseptics] Monograph will prolong exposures that may cause irretrievable

medical injury to those exposed.”

                       b.     Markey Letter

       In the Markey Letter, FDA states that it “shares” Rep. Markey’s “concern over the

potential effects of triclosan and triclocarban as endocrine disruptors that have emerged since”

FDA issued its most recent tentative final monograph in 1994. The letter reports on “studies in

several different animal species (including mammals), that suggest triclosan may interfere with

the thyroid system and have other endocrine-disrupting effects.” FDA thus concludes that

“existing data raise valid concerns about the effects of repetitive daily human exposure to these

antiseptic ingredients.”

       The Markey Letter also acknowledges a lack of data regarding the long-term effects of

triclosan, including dermal application, reproductive and developmental toxicity, and its

potential as an endocrine disruptor, and reports that a study of triclosan by the National Center

for Toxological Research is underway pursuant to FDA’s request.

       Finally, regarding the concern that proliferation of antiseptic antimicrobial hand soaps

will lead to the development of antibiotic-resistant bacteria, FDA reported that numerous

2
 “Body burden” is not defined in the Janssen declaration. The Oxford English Dictionary
defines “body burden” as “the total amount of a radioactive element or other (usually toxic)
substance in a human or animal body.”
                                               9
laboratory studies “suggest that it is relatively easy for bacteria to develop altered susceptibilities

to both antiseptics and antibiotics in the laboratory setting,” but that there “was no definitive

correlation between altered susceptibility to antibacterial active ingredients and antibiotics.”

Based on the data, the FDA concluded that “the possibility that antiseptics contribute to changes

in antibiotic susceptibility warrants further evaluation.”

       Consistent with the Markey Letter, in a declaration submitted by FDA, FDA witness

Charles J. Ganley, Director of the Office of Drug Evaluation and Research IV at FDA’s Center

for Drug Evaluation and Research, attributes FDA’s delay in issuing the final monograph for

antiseptic antimicrobial chemicals to the need for further evaluation of concerns raised by new

data, including that antiseptic active ingredients may act as endocrine disruptors, that

antimicrobial products—including triclosan and triclocarban—may play a role in the

development of antimicrobial and antibiotic resistance, and that the proliferation of antimicrobial

products raises concerns about the long-term health effects of higher levels of exposure to these

substances.

                       c.      FDA Consumer Notice

       Similarly, the FDA Consumer Notice informs consumers that FDA does not have

evidence that triclosan-containing soap provides extra health benefits over soap and water. It

acknowledges that “[a]nimal studies have shown that triclosan alters hormone regulation,” but

cautions that “data showing effects in animals don’t always predict effects in humans,” and

reassures consumers that triclosan “is not currently known to be hazardous to humans.” It

advises consumers who may be concerned to “wash with regular soap and water” instead of

triclosan-containing soaps.



                                                  10
       B.      Decision of the District Court

       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.

                                           DISCUSSION

       “[T]he irreducible constitutional minimum of standing” derives from Article III, Section

2 of the U.S. Constitution, which limits federal judicial power to “cases” and “controversies.”

U.S. Const. art. III, § 2; Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992). To establish

that a case or controversy exists so as to confer standing under Article III, a plaintiff must satisfy

three elements: (a) the plaintiff must suffer an “injury in fact,” (b) that injury must be “fairly

traceable” to the challenged action, and (c) the injury must be likely to be “redressed by a

favorable decision” of the federal court. Id. at 560-61 (alteration omitted). A membership

organization like NRDC may assert the standing of its members if, among other requirements

not at issue here, it establishes that at least one of its members has standing to sue individually.

Summers v. Earth Island Inst., 555 U.S. 488, 494, 498 (2009).

       We review de novo both a district court’s grant of summary judgment and its

determination of standing. Cacchillo v. Insmed, Inc., 638 F.3d 401, 404 (2d Cir. 2011); Schick v.

Berg, 430 F.3d 112, 115 (2d Cir. 2005). A grant of summary judgment is proper only “if the

movant shows that there is no genuine dispute as to any material fact and the movant is entitled

to judgment as a matter of law.” Fed. R. Civ. P. 56(a). In considering the evidence, the court

must “resolve all ambiguities, and credit all factual inferences that could rationally be drawn, in

                                                  11
favor of the party opposing summary judgment,” Brown v. Henderson, 257 F.3d 246, 251 (2d

Cir. 2001) (quotation marks omitted), even if contrary inferences might reasonably be drawn,

Kaytor v. Elec. Boat Corp., 609 F.3d 537, 545 (2d Cir. 2010). The party asserting jurisdiction,

here NRDC, bears the burden of proof as to standing. Lujan, 504 U.S. at 561. To defend against

summary judgment for lack of standing, a plaintiff “must set forth by affidavit or other evidence

specific facts” supporting standing, as is generally required under Rule 56. Id. (internal

quotation marks omitted); Fed. R. Civ. P. 56(c).

       This appeal requires us to determine whether NRDC has presented sufficient evidence to

withstand summary judgment for lack of standing as to triclosan and triclocarban. The inquiry

as to triclosan concerns two elements of Article III standing: the injury-in-fact requirement and

the requirement that the injury be fairly traceable to the challenged conduct. First, we must

determine whether NRDC’s evidence establishes a genuine dispute of material fact as to whether

at least one of its members’ exposure to triclosan at the workplace satisfies the injury-in-fact

requirement. At issue is whether exposure to triclosan constitutes an injury under Article III

notwithstanding the scientific uncertainty as to whether triclosan is harmful to human health.

We hold that NRDC’s evidence is sufficient to satisfy the injury-in-fact requirement

notwithstanding the scientific uncertainty as to triclosan’s harmfulness to humans.

       We must next determine whether the injury of triclosan exposure is “fairly traceable” to

the challenged action—here, FDA’s alleged delay in finalizing its regulation of topical antiseptic

antimicrobial over-the-counter drugs. 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.

                                                 12
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.

I.     Triclosan

       Since NRDC need only show that at least one of its members has standing to sue

individually in order to establish representational standing, we focus exclusively on the

declaration of Diana Owens because it is sufficient to satisfy this requirement as to triclosan.

       A.      Injury in Fact

       We begin by considering whether NRDC presented sufficient evidence to withstand

summary judgment as to whether at least one of its members’ workplace exposure to triclosan

satisfies the injury-in-fact requirement of Article III standing. NRDC argues that at least one of

its members suffers an injury in fact because its evidence shows that its members are exposed to

triclosan in the workplace and that triclosan may be dangerous to human health. The

government responds principally that NRDC’s evidence is insufficient to establish an injury in

fact because there is no evidence that triclosan actually harms human health and because NRDC

has not produced quantitative evidence of the risk that triclosan may harm human health.




                                                 13
                  1.      Establishing Injury in Fact Based on Exposure to a Potentially
                          Harmful Product

           Injury in fact is “an invasion of a legally protected interest which is (a) concrete and

particularized, and (b) actual or imminent, not conjectural or hypothetical.” Lujan, 504 U.S. at

560 (citation and internal quotation marks omitted). Here, the FFDCA establishes an interest in

the public being protected “from products not proven to be safe and effective for their alleged

uses.” United States v. Diapulse Corp. of Am., 457 F.2d 25, 27-28 (2d Cir. 1972). Owens’s

declaration, which we accept as true, establishes that, in her work as a veterinary technician, she

is frequently exposed to soap that contains triclosan—a chemical that has not been proven to be

safe and effective for use in soap. NRDC’s evidence shows that triclosan has endocrine-

disrupting properties and may cause cancer and other health problems. FDA argues that this

alleged injury is not sufficiently “actual or imminent” to satisfy Article III because there is

scientific uncertainty as to whether triclosan is actually harmful to humans.

           This court’s leading case on risk-based injury is Baur v. Veneman, 352 F.3d 625 (2d Cir.

2003). In Baur, this court held that “exposure to potentially harmful products” may satisfy the

injury-in-fact requirement of Article III standing in “the specific context of food and drug safety

suits.” Id. at 634. This court explained that, in such cases, “the relevant ‘injury’ for standing

purposes may be exposure to a sufficiently serious risk of medical harm—not the anticipated

medical harm itself.” Id. at 641. That is, the injury contemplated by exposure to a potentially

harmful product is not the future harm that the exposure risks causing, but the present exposure

to risk.

           To establish injury in fact based on exposure to a potentially harmful product, a plaintiff

must show “a credible threat of harm” due to that exposure. Id. at 637. “[T]he injury-in-fact


                                                    14
analysis is highly case-specific, and the risk of harm necessary to support standing cannot be

defined according to a universal standard.” Id. (citation omitted). Under Baur, whether a

plaintiff has established a credible threat of harm sufficient to confer standing based on exposure

to a potentially harmful product is a qualitative inquiry in which the court should consider both

the probability of harm and the severity of the potential harm. Id.

                2.     Exposure to Triclosan as Injury in Fact

        There is no genuine dispute that triclosan is potentially harmful and that NRDC member

Owens is exposed to triclosan at her workplace; whether NRDC has presented sufficient

evidence regarding injury in fact thus turns on whether, under Baur, NRDC has demonstrated a

“credible threat of harm” due to Owens’s triclosan exposure. Under Baur, to determine whether

there is evidence of a credible threat of harm, we consider the probability of harm in relation to

its severity.

        As to the severity of the harm triclosan could cause, the evidence, taken in the light most

favorable to NRDC, shows that triclosan has endocrine-disrupting properties, easily absorbs into

the human bloodstream, and may contribute to the growth of cancer. Owens avers that she is at a

slightly increased risk of ovarian cancer. There is also evidence that triclosan can disrupt thyroid

regulation, and earlier FDA studies cited concerns about liver damage.

        Regarding the probability of harm, Owens’s declaration establishes that she washes her

hands with triclosan-containing soap more than fifty times in a typical workday. The evidence is

silent, however, as to the precise likelihood that such frequent exposure to triclosan harms

humans. In considering how this uncertainty as to triclosan’s harmfulness affects the standing

inquiry, this court’s analysis in Baur is instructive. In Baur, plaintiff Baur satisfied the injury-in-

fact requirement so as to withstand a motion to dismiss his suit challenging regulations that

                                                  15
permitted beef from “downed” cattle to enter the food supply.3 Baur alleged that downed cattle

were particularly likely to be infected with Bovine Spongiform Encephalopathy (“BSE”) and

that eating beef from BSE-infected cattle would put consumers at risk of contracting variant

Creutzfeldt Jakob disease (“vCJD”), a deadly and incurable disease transmissible to humans by

cattle with BSE. Baur, 352 F.3d at 628. Baur alleged that he was a regular eater of beef and

argued that he was injured for standing purposes because the presence in the market of beef from

downed cattle put him at risk of eating BSE-infected beef and thereby contracting vCJD.

        The Baur court concluded that Baur had established a credible threat of harm even

though the likelihood that Baur would contract vCJD by eating beef from a food supply that

included beef from downed cattle was uncertain. Id. at 641. Baur did not allege that BSE was

present in the United States, nor did he quantify the risk that BSE was present in the United

States or allege that there was a particular likelihood that BSE had entered the United States.

Moreover, even assuming BSE had entered the United States, Baur made no allegations as to the

likelihood that he would consume beef from downed cattle. Instead, Baur alleged only that BSE

may be present in the United States and argued that, if it were, the government would be unable

to detect it. Id. at 638-41.

        This court nonetheless concluded that Baur had established a credible threat of harm

sufficient to remove his claimed injury from the realm of speculation due to his exposure to a

beef market that included beef from downed cattle. We reached this decision based primarily on

Baur’s allegations that: “(1) a form of BSE may already [have been] present in the United States,

(2) available testing methods [did] not adequately detect BSE in downed cattle,” and (3) the

challenged federal regulations allowed meat from downed cattle to enter the food stream. Id. at
3
 “‘Downed’ is an industry term used to describe animals that collapse for unknown reasons and
are too ill to walk or stand prior to slaughter.” Baur, 352 F.3d at 628.
                                                  16
640. It was significant, too, that the government itself raised concerns about the inadequacy of

the testing methods in place. See id. at 639.

       Considering NRDC’s evidence in light of the analysis in Baur, we conclude that NRDC

has established a credible threat notwithstanding the uncertainty as to triclosan’s harmfulness to

humans. Just as plaintiff Baur was able to establish a credible threat based on allegations that

BSE may be present in the United States and that the challenged regulatory regime in place

would be unable to detect it, NRDC’s evidence shows that triclosan may be harmful, that FDA is

unable to determine whether it is, and that FDA’s failure to regulate allows triclosan to enter the

market without its safety having been confirmed. Moreover, just as in Baur, the government’s

own report confirmed the plaintiff’s concerns as to the inadequacy of testing methods. 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. Just as the government in

Baur could not confirm that meat from downed cattle was not infected with BSE, the

government in the instant case cannot confirm that exposure to triclosan-containing soaps is safe

for humans.

       Considering the potential harms caused by triclosan-containing soap together with FDA’s

inability to confirm that the soap will not cause these harms, and keeping in mind that the

FFDCA establishes an interest in being protected from products of unproven safety, we conclude

that NRDC has presented evidence sufficient to withstand summary judgment that member

Owens’s frequent exposure to triclosan is an injury in fact under Article III.



                                                17
       The government argues that the uncertainty as to triclosan’s harmfulness bars NRDC

from establishing a credible threat under Baur. Given Baur’s treatment of uncertainty, the

government’s argument lacks merit. What is more, this court squarely held in New York Public

Interest Research Group v. Whitman, 321 F.3d 316 (2d Cir. 2003) (“NYPIRG”), that a plaintiff

may establish injury in fact in the environmental context based on the “increased health-related

uncertainty” that arose from exposure to unregulated emissions. Id. at 325 (emphasis omitted).

We rejected any distinction between actual exposure to excess pollutants and uncertainty about

such exposure as “one largely without a difference.” Id. at 326. We reasoned that both actual

and uncertain exposure caused personal and economic harm and that, “[t]o the extent that this

distinction [wa]s meaningful, it affect[ed] the extent, not the existence, of the injury.” Id.; see

also LaFleur v. Whitman, 300 F.3d 256, 270 (2d Cir. 2002) (petitioner had standing to challenge

emissions even if pollutant levels remained within air quality standards because statute

recognized that within-standards pollution levels still had “potentially adverse [e]ffects”).

       The government maintains that Baur and NYPIRG are distinguishable from NRDC’s case

because they concerned chemicals known to be dangerous, whereas triclosan’s potential risks are

uncertain. The gravamen of this argument is that a plaintiff may establish standing

notwithstanding uncertainty as to exposure to a substance so long as the substance is

unquestionably harmful, but that a plaintiff may not establish standing based on unquestionable

exposure to a potentially dangerous substance if there is any uncertainty as to its dangerousness.

       Baur renders this purported distinction untenable. In Baur, this court explicitly

recognized that injury based on exposure to potentially or actually harmful products can take at

least two forms: (1) “uncontested exposure to a potentially harmful substance,” as here, and (2)

“potential exposure to an undisputedly dangerous contaminant,” as in Baur and NYPIRG. Baur,

                                                 18
352 F.3d at 634 n.8. In Baur, the risk of exposure to BSE was uncertain, but it was clear that

BSE was harmful. Here, in contrast, the evidence is clear that Owens is frequently exposed to

triclosan, but the risk that triclosan will harm her is uncertain. The Baur court explained that

there was “no reason to distinguish” between these two scenarios: “In both types of cases,

standing should rest on all of [the] relevant facts underlying the plaintiff’s claim, not on the

happenstance of which particular facts happen to be in dispute.” Id. In short, an injury like that

of NRDC member Owens, based on definite exposure to a substance of uncertain dangerousness,

is not necessarily any less “actual” or “imminent” than an injury based on uncertain exposure to

an undisputedly dangerous contaminant. In each case, whether the plaintiff has satisfied the

injury-in-fact requirement must be based on the specific circumstances.

               3.      Plaintiff’s Summary Judgment Burden to Establish Risk-Based
                       Standing

       Next, the government contends that NRDC’s evidence is insufficient to withstand

summary judgment because Baur requires a plaintiff asserting standing based on enhanced risk

to present quantitative evidence of the “precise risk” in order to withstand summary judgment.

NRDC did not submit such quantitative evidence, but neither Baur nor any other authority of

which we are aware articulates such a requirement. Rather, to defend against summary

judgment for lack of standing, a plaintiff “must set forth by affidavit or other evidence specific

facts” supporting standing, as is generally required under Rule 56. Lujan, 504 U.S. at 561

(internal quotation marks omitted); Fed. R. Civ. P. 56. Those “specific facts” need not

necessarily include quantitative data.

       To the extent Baur’s discussion of statistical evidence bears on the question before us,

Baur supports NRDC’s position given that Baur addressed a motion to dismiss rather than a


                                                 19
motion for summary judgment. The Baur court declined to require statistical evidence at the

motion-to-dismiss stage principally because it reasoned that requiring such evidence would

conflate the standing inquiry with the inquiry into the merits of the agency’s regulatory decision.

See Baur, 352 F.3d at 643. We agree that “the evaluation of the amount of tolerable risk is better

analyzed as an administrative decision governed by the relevant statutes rather than a

constitutional question governed by Article III.” Id. Here, the merits determination will include

consideration of “the nature and extent of the interests prejudiced by delay” and whether “human

health and welfare are at stake.” See Telecomms. Research & Action Ctr. v. FCC, 750 F.2d 70,

80 (D.C. Cir. 1984) (setting forth test for determining if agency action is unreasonably delayed).

We reject FDA’s invitation to “raise the standing hurdle higher than the necessary showing for

success on the merits.” See Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528

U.S. 167, 181 (2000).

        NRDC has produced evidence that sets forth specific facts as to the risks of triclosan

exposure by presenting both an expert declaration and FDA’s own statements confirming its

concern as to the risks of triclosan exposure. Accordingly, we conclude that NRDC has satisfied

its burden on summary judgment of demonstrating that at least one of its members’ exposure to

triclosan constitutes an “injury in fact” to confer standing under Article III.

        B.      Causation

        We now consider whether NRDC lacks standing because, as the district court

determined, its members’ exposure to triclosan is avoidable. This inquiry concerns the causation

or “traceability” requirement of Article III standing. To satisfy this requirement, “there must be

a causal connection between the injury and the conduct complained of—the injury has to be

‘fairly . . . trace[able] to the challenged action of the defendant, and not . . . th[e] result [of] the

                                                    20
independent action of some third party not before the court.’” Lujan, 504 U.S. at 560 (citation

omitted). The government argues that NRDC lacks standing because its members’ alleged

injury is “self-inflicted” because they may avoid triclosan exposure in the workplace by

purchasing triclosan-free soap to bring to work and because they have not demonstrated that

their employers are unwilling to provide triclosan-free soap. We disagree.

       To be sure, a plaintiff may not establish injury for standing purposes based on a “self-

inflicted” injury. See St. Pierre v. Dyer, 208 F.3d 394, 403 (2d Cir. 2000). An injury is self-

inflicted so as to defeat the causation necessary to establish standing, however, “only if . . . the

injury is so completely due to the plaintiff’s own fault as to break the causal chain.” Id. at 402.

Under this standard, NRDC member Owens’s exposure to triclosan is not self-inflicted.

NRDC’s evidence shows that FDA’s conduct contributes to Owens’s triclosan exposure because

triclosan would not be available on the market but for FDA’s failure to finalize its regulation.

Neither Owens’s failure to purchase triclosan-free soap nor her failure to advocate more

forcefully with her employer is sufficient to break the causal chain.

       As to the availability of triclosan-free soap to bring to the workplace, incurring the

expense of buying such soap would itself constitute an injury in fact. Even a small financial loss

is an injury for purposes of Article III standing. See United States v. Students Challenging

Regulatory Agency Procedures (SCRAP), 412 U.S. 669, 689 n.14 (1973) (“[A]n identifiable

trifle is enough for standing.”). Because NRDC would have standing based on Owens’s

financial injury even if she avoided triclosan exposure by buying triclosan-free soap, the

availability of triclosan-free soap does not defeat NRDC’s standing.

       Equally unavailing is the government’s argument that NRDC lacks standing because its

members did not sufficiently establish that their employers were unwilling to provide triclosan-

                                                  21
free soap. We explained in St. Pierre that “[s]o long as the defendants have engaged in conduct

that may have contributed to causing the injury, it would be better to recognize standing.” St.

Pierre, 208 F.3d at 402 (internal quotation marks omitted). Here, the failure to take affirmative

action to advocate with an employer does not render the exposure to triclosan at the hands of the

employer “self-inflicted” so as to defeat standing because FDA’s allegedly unreasonable delay in

regulating triclosan remains a contributing factor to Owens’s exposure; according to NRDC’s

evidence, but for FDA’s challenged inaction, triclosan-containing soaps would not be available

on the market. We therefore conclude that NRDC has satisfied the requirement that its

members’ injury be “fairly traceable” to the challenged action.

II.    Triclocarban

       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. The government argues that this injury is not

cognizable under Article III because the NRDC’s members suffer at the hands of this risk “in no

way that distinguishes them from the population at large”—that is, that their claimed injury is

not sufficiently concrete and particularized, as required to establish injury in fact. See Lujan,

504 U.S. at 560.

       At oral argument, NRDC maintained that we need not reach this question if we were to

determine, as we have, that NRDC had standing to challenge the alleged delay in regulating

triclosan. NRDC reasoned that because FDA regulates triclosan and triclocarban by means of

                                                 22
the same monograph, if NRDC were to succeed on the merits in compelling FDA to finalize its

regulation of triclosan, FDA would necessarily also be compelled to finalize its regulation of

triclocarban. While NRDC may be correct as a practical matter, we are aware of no obligation

on FDA’s part to promulgate regulations of triclosan and triclocarban simultaneously. As we

observed in Baur, “a plaintiff must demonstrate standing for each claim and form of relief

sought.” Baur, 352 F.3d at 641 n.15. Here, NRDC seeks finalization of the entire monograph

governing topical antimicrobial drug products. To pursue such broad relief, however, NRDC

“must also demonstrate a credible threat of [harm]” from the other chemicals it seeks to compel

FDA to regulate. Id. While it may not be practicable for FDA to finalize its regulation of

triclosan without also finalizing its regulation of other antimicrobial drug products, NRDC has

only established standing to compel FDA to finalize its regulation of triclosan, and its standing

as to triclosan does not entitle it to seek regulation of other antimicrobial drug products should it

prove practicable for FDA to sever its regulation of these substances. We therefore are not

persuaded that it is unnecessary to this appeal to determine whether NRDC has standing as to

triclocarban, and we hold that NRDC lacks standing as to triclocarban.

         In the Markey letter, FDA itself recognized a risk that antibiotic-resistant bacteria would

develop. But apart from appearing insufficiently particular to establish injury, this claim seems

too causally remote to fit comfortably within the Baur standard. The basis for standing for the

regulation of triclosan, discussed above, is based on direct, frequent exposure to triclosan

combined with the known fact that triclosan enters the human bloodstream, is an endocrine

disruptor, and may cause cancer. Exposure to triclosan in this manner is a present injury in

which triclosan may work changes directly upon the human body; whether those changes are

ultimately harmful may be uncertain, but there is no uncertainty that any harm will be directly

caused by frequent direct exposure to triclosan.
                                                   23
       The claim that the proliferation of triclocarban may lead to the development of antibiotic-

resistant bacteria, in contrast, involves unspecified bacteria or microbes that NRDC members

may not ever come into contact with. And in order for those bacteria or microbes to harm

plaintiffs, there must be an intermediate step in which triclocarban causes those bacteria to

become resistant to antibiotics. This claim thus seems less like a present injury and more like a

threatened injury that is contingent and far-off rather than imminent. We therefore conclude that

NRDC lacks standing as to the regulation of triclocarban.

                                         CONCLUSION

       For the reasons stated above, the judgment of the district court hereby is VACATED and

the case is REMANDED to the district court for further proceedings consistent with this opinion.




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