Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 57

MEMORANDUM OF LAW in Support re: 56 MOTION for Summary Judgment on Plaintiffs Third Claim for Relief.. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc.. (Bernard, Mitchell)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK
NATURAL RESOURCES DEFENSE
COUNCIL, INC.; CENTER FOR SCIENCE
IN THE PUBLIC INTEREST; FOOD
ANIMAL CONCERNS TRUST; PUBLIC
CITIZEN, INC.; and UNION OF
CONCERNED SCIENTISTS, INC.,

)
)
)
)
)
)
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Plaintiffs,
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v.
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UNITED STATES FOOD AND DRUG
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ADMINISTRATION; MARGARET
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HAMBURG, in her official capacity as
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Commissioner, United States Food and Drug )
Administration; CENTER FOR
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VETERINARY MEDICINE; BERNADETTE )
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DUNHAM, in her official capacity as
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Director, Center for Veterinary Medicine;
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UNITED STATES DEPARTMENT OF
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HEALTH AND HUMAN SERVICES; and
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KATHLEEN SEBELIUS, in her official
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capacity as Secretary, United States
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Department of Health and Human Services,
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Defendants.
)

11 CIV 3562 (THK)
ECF Case

MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’ MOTION FOR
SUMMARY JUDGMENT ON THEIR THIRD CLAIM FOR RELIEF
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
[phone]
[phone] (fax)
[e-mail]

Avinash Kar, admitted pro hac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th Floor
San Francisco, California 94104
[phone]
[phone] (fax)
[e-mail]; [e-mail]
Counsel for Plaintiffs

Dated: February 21, 2012

TABLE OF CONTENTS
TABLE OF AUTHORITIES .......................................................................................................... ii
INTRODUCTION .......................................................................................................................... 1
PERTINENT BACKGROUND...................................................................................................... 1
The Food and Drug Act .......................................................................................................1
The 1999 Petition .................................................................................................................2
The 2005 Petition .................................................................................................................3
Draft Guidance No. 209 .......................................................................................................3
The Petition Denials .............................................................................................................4
ARGUMENT .................................................................................................................................. 6
I.

Standard of Review ..............................................................................................................6

II.

FDA’s Reasons for Denying the Petitions Find No Basis in the Food and Drug Act .........6
A.
B.

FDA’s Issuance of Voluntary Guidance Cannot Excuse Its Failure to
Conduct the Required Statutory Inquiry ............................................................... 10

C.
III.

FDA’s Refusal to Address the Merits of the Petitions Is Invalid under
Massachusetts v. EPA ............................................................................................. 7

The Petition Denials Are Blind to the Purpose of the Food and Drug Act ........... 12

FDA’s Reasons for Denying the Petitions Are Arbitrary ..................................................13
A.
B.

IV.

FDA Pronouncements Convey Agreement with the Premise of the Petitions...... 13
FDA Presents No Evidence Supporting the Efficacy of Voluntary Measures ..... 15

Plaintiffs Have Standing to Pursue this Claim...................................................................18

CONCLUSION ............................................................................................................................. 20

i

TABLE OF AUTHORITIES
CASES
Am. Horse Prot. Ass’n v. Lyng,
812 F.2d 1 (D.C. Cir. 1987) .............................................................................................12
Am. Lung Ass’n v. EPA,
134 F.3d 388 (D.C. Cir. 1998) ..........................................................................................15
Amnesty Int’l USA v. Clapper,
638 F.3d 118 (2d Cir. 2011)...............................................................................................19
Ass’n of Irritated Residents v. EPA,
Nos. 09-71383, 09-71404, 2012 WL 251912 (9th Cir. Jan. 27, 2012) ..............................15
Baur v. Veneman,
352 F.3d 625 (2d Cir. 2003)...............................................................................................19
Bldg. & Constr. Trades Council v. Downtown Dev., Inc.,
448 F.3d 138 (2d Cir. 2006)...............................................................................................18
Bowen v. Am. Hosp. Ass’n,
476 U.S. 610 (1986) ..................................................................................................... 17-18
Detsel by Detsel v. Sullivan,
895 F.2d 58 (2d Cir. 1990) ................................................................................................17
Friends of the Earth, Inc. v. Gaston Copper Recycling Corp.,
204 F.3d 149 (4th Cir. 2000) .............................................................................................19
Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,
528 U.S. 167 (2000) ...........................................................................................................19
Hunt v. Wash. State Apple Adver. Comm’n,
432 U.S. 333 (1977) ...........................................................................................................18
Massachusetts v. EPA,
549 U.S. 497 (2007) ................................................................................................... passim
Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co.,
463 U.S. 29 (1983) .........................................................................................................6, 15
Natural Res. Def. Council v. EPA,
595 F. Supp. 1255 (S.D.N.Y. 1984)...................................................................................11

ii

Natural Res. Def. Council v. EPA,
658 F.3d 200 (2d Cir. 2011) ................................................................................................6
Nova Scotia Food Prods. Corp.,
568 F.2d 240 (2d Cir. 1977)...........................................................................................1, 12
Nutritional Health Alliance v. FDA,
318 F.3d 92 (2d Cir. 2003) ............................................................................................1, 12
Pub. Citizen, Inc. v. Nat’l Highway Traffic Safety Admin.,
374 F.3d 1251 (D.C. Cir. 2004) ........................................................................................11
Pub. Citizen v. Nuclear Regulatory Comm’n,
901 F.2d 147 (D.C. Cir. 1990) ...........................................................................................11
Rumsfeld v. Forum for Academic & Institutional Rights, Inc.,
547 U.S. 47 (2006) .............................................................................................................18
W. Harlem Envtl. Action v. EPA,
380 F. Supp. 2d 289 (S.D.N.Y. 2005)................................................................................13
ADMINISTRATIVE ADJUDICATIONS
Withdrawal of Approval of the New Animal Drug Application for Enrofloxacin in Poultry,
No. 2000N-1571 (FDA July 27, 2005) ..............................................................................12
STATUTES AND REGULATIONS
21 C.F.R. § 10.25 ...........................................................................................................................19
21 C.F.R. § 10.25(a).........................................................................................................................2
21 C.F.R. § 10.3 .............................................................................................................................18
21 CFR § 10.45(d) .....................................................................................................................6, 18
Pub. L. No. 87-781, § 102(d), 76 Stat. 780 (1962) ........................................................................12
5 U.S.C. § 706(2)(A)........................................................................................................6, 7, 10, 13
21 U.S.C. § 355(e)(1)-(2) ...............................................................................................................12
21 U.S.C. § 360b ..............................................................................................................................7
21 U.S.C. § 360b(e)(1) ........................................................................................................... passim
21 U.S.C. § 360b(i) ......................................................................................................................2, 7
iii

21 U.S.C. § 393(b)(1)-(2) ......................................................................................................1, 2, 12
21 U.S.C. § 393(d)(2) ......................................................................................................................7
42 U.S.C. § 7521(a)(1) .....................................................................................................................8
LEGISLATIVE HISTORY
S. Rep. No. 87-1744 (1962), reprinted in 1962 U.S.C.C.A.N. 2884 .............................................12
OTHER AUTHORITIES
42 Fed. Reg. 43,772 (Aug. 30, 1977)...............................................................................................9
42 Fed. Reg. 56,264 (Oct. 21, 1977)................................................................................................9

iv

INTRODUCTION
In November 2011, the U.S. Food and Drug Administration (FDA) denied two citizen
petitions urging it to rescind approvals for nontherapeutic uses in livestock of antibiotics critical
to human medicine. The petitions cited and discussed voluminous, reliable scientific data
demonstrating that the use of antibiotics to stimulate animal growth and improve feed efficiency
threatens human health by promoting antibiotic resistance in bacteria that can be transferred to
and infect human beings. In denying the petitions, FDA did not engage with the scientific
evidence on which the petitioners relied. Instead, defying its statutory duty to ban previously
approved drug uses that are unsafe or not shown to be safe for human health, FDA denied the
petitions in favor of an unenforceable plea for industry cooperation.
FDA’s approach finds no basis in the Federal Food, Drug, and Cosmetic Act (Food and
Drug Act) and is thus not in accordance with law within the meaning of the Administrative
Procedure Act (APA). Moreover, FDA has failed to articulate a rational connection between its
professed concerns about nontherapeutic antibiotic use in livestock and its decision not to take
binding action. Nor has the agency presented a shred of evidence that its alternative,
extrastatutory method will work. The lack of such evidence deprives FDA’s action of a reasoned
basis, in further violation of the APA. For these reasons, detailed below, plaintiffs seek an order
vacating the denials and remanding the matter to FDA with instructions to address the petitions
promptly on their merits.
PERTINENT BACKGROUND
The Food and Drug Act
The “overriding purpose” of the Food and Drug Act is “to protect the public health.”
Nutritional Health Alliance v. FDA, 318 F.3d 92, 98 (2d Cir. 2003) (quoting United States v.
Nova Scotia Food Prods. Corp., 568 F.2d 240, 246 (2d Cir. 1977)); see also 21 U.S.C.
1

§ 393(b)(1)-(2) (setting forth FDA’s mission to promote and protect the public health). The Act
directs FDA to withdraw approval for an animal drug, and revoke the regulation setting forth
approved conditions of use, if the agency finds that the drug is “unsafe” or “not shown to be
safe” for human health. Id. § 360b(e)(1)(A)-(B), (i). FDA regulations allow citizens to petition
the agency to “issue, amend, or revoke a regulation or order, or to take or refrain from taking any
other form of administrative action.” 21 C.F.R. § 10.25(a).
The 1999 Petition
In March 1999, plaintiffs Center for Science in the Public Interest (CSPI), Food Animal
Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists (UCS) petitioned
FDA to “rescind approvals for subtherapeutic uses in livestock of any antibiotic used in (or
related to those used in) human medicine.” Citizen Petition (1999 Petition) 1-2 (Mar. 9, 1999),
Ex. I to Decl. of Jennifer A. Sorenson, Oct. 5, 2011 (Sorenson Decl.) (Dkt. 33-9). The petition
defined “subtherapeutic use” of antibiotics as “the administration of those drugs at a dosage less
than is necessary and/or for a period of time longer than is necessary to treat an infection.” Id. at
5. The petition included in this category uses of antibiotics in livestock for “growth promotion,
improved feed efficiency, and disease prevention.” Id. at 2. Today, such uses may also be
referred to as “nontherapeutic.” See, e.g., FDA, Draft Guidance No. 209, at 4 (June 28, 2010),
Sorenson Decl. Ex. O (Dkt. 33-15) (noting that “the use of medically important antimicrobial
drugs in food-producing animals for production or growth-enhancing purposes” is often referred
to as “nontherapeutic” or “subtherapeutic” use).
The 1999 Petition is thirty-seven pages long and discusses in detail the science
supporting the petitioners’ request. It refers to and explains studies relating to the widespread
subtherapeutic use of antibiotics in livestock; how such use leads to development of antibioticresistant bacteria; how antibiotic-resistant bacteria can be transferred from animals to human
2

beings; how bacteria may transfer resistance genes to other bacteria; and how subtherapeutic
antibiotic use reduces the effectiveness of medically important antibiotics, jeopardizing public
health. See 1999 Petition 9-23. The 1999 Petition also includes a review of expert support for a
phase-out of subtherapeutic antibiotic use in livestock. See id. at 23-25.
The 2005 Petition
In April 2005, FACT and UCS submitted a second petition to FDA, this time asking the
agency to “withdraw approvals for herdwide/flockwide uses of [specific] antibiotics in chicken,
swine, and beef cattle for purposes of growth promotion (including weight gain and feed
efficiency) and disease prevention and control (except for non-routine use where a bacterial
infection has been diagnosed within a herd or flock).” Citizen Petition (2005 Petition) 1 (Apr. 7,
2005), Sorenson Decl. Ex. K (Dkt. 33-11). The petition covered penicillins, tetracyclines,
aminoglycosides, streptogramins, macrolides, lincomycin, and sulfonamides. Id. The 2005
Petition was prompted by a 2003 FDA guidance (Guidance for Industry No. 152), in which the
agency described a risk-based approach for evaluating proposed new drugs for food-producing
animals. See FDA, Guidance for Industry No. 152 (Oct. 23, 2003), Sorenson Decl. Ex. M (Dkt.
33-13). Guidance No. 152 includes a table presenting assessments of overall risk from the use of
medically important antibiotics in livestock, based on factors FDA considers pertinent. See id. at
21. Using FDA’s own risk assessment method, the 2005 Petition demonstrates that the approved
uses challenged by the petitioners present an unacceptable level of risk. See 2005 Petition 9-16.
Draft Guidance No. 209
In June 2010, FDA published for public comment Draft Guidance No. 209, entitled The
Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. In the
opening paragraph, the Draft Guidance states: “The development of resistance to this important
class of drugs [i.e., antimicrobials or antibiotics], and the resulting loss of their effectiveness as
3

antimicrobial therapies, poses a serious public health threat.” Draft Guidance No. 209, at 3. The
agency reprised this theme on the following page: “Antimicrobial resistance, and the resulting
failure of antimicrobial therapies in humans, is a mounting public health problem of global
significance.” Id. at 4.
FDA went on to review forty years’ worth of “key scientific reports” by leading public
health and government authorities, such as the Institute of Medicine (of the National Academy of
Sciences), the World Health Organization (WHO), the European Commission, the Food and
Agriculture Organization of the United Nations, and the U.S. Government Accountability Office
(GAO). See id. at 4-13. Based on its review, FDA concluded that “the overall weight of evidence
available to date supports the conclusion that using medically important antimicrobial drugs for
[livestock] production purposes is not in the interest of protecting and promoting the public
health.” Id. at 13. FDA also quoted the comments of its parent agency, the U.S. Department of
Health and Human Services (HHS), after HHS had reviewed a 2004 GAO report and eleven
additional studies: “‘We believe that there is a preponderance of evidence that the use of
antimicrobials in food-producing animals has adverse human consequences. . . . There is little
evidence to the contrary.’” Id. at 12.
Draft Guidance No. 209 concludes with a set of recommendations for the “judicious use”
of antibiotics in livestock. Id. at 15-17. FDA has not finalized the Draft Guidance. Even in final
form, FDA’s guidance documents “do not establish legally enforceable responsibilities.” Id. at 2.
They offer suggestions or recommendations; they do not impose requirements. Id.
The Petition Denials
In November 2011, twelve and six years after the citizen petitions were filed, and one day
before FDA’s opposition to plaintiffs’ initial motion for summary judgment was due in this
Court, FDA denied the petitions in two nearly identical letters, on identical grounds. Final
4

Response to Citizen Petition, New Dkt. No. FDA-1999-P-1286 (Denial of 1999 Petition) (Nov.
7, 2011), Ex. A to Decl. of Mitchell S. Bernard, Feb. 21, 2012 (Bernard Decl.); Final Response
to Citizen Petition, New Dkt. No. FDA-2005-P-0007 (Denial of 2005 Petition) (Nov. 7, 2011),
Bernard Decl. Ex. B. The denial letters did not address, much less dispute, the science underlying
the petitions. To the contrary, FDA acknowledged that it “share[s] [petitioners’] concern about
the use of medically important antimicrobial drugs in food-producing animals for growth
promotion and feed efficiency indications (i.e., production uses).” Denial of 1999 Petition 1;
Denial of 2005 Petition 1. Nonetheless, FDA wrote that “for various reasons the Agency has
decided not to institute formal withdrawal proceedings at this time and instead is currently
pursuing other alternatives to address the issue of antimicrobial resistance related to the
production use of antimicrobials in animal agriculture.” Denial of 1999 Petition 3; Denial of
2005 Petition 2. The “other alternative[]” the denial letters identify is the set of voluntary
recommendations embodied in Draft Guidance No. 209. Denial of 1999 Petition 3-4; Denial of
2005 Petition 3-4.
The agency expressed confidence in the efficacy of the cooperative measures
contemplated by the Draft Guidance, stating: “Based on feedback this Agency has received
following the issuance of draft [Guidance No. 209], FDA believes that the animal
pharmaceutical industry is generally responsive to the prospect of working cooperatively with
the Agency to implement the principles recommended in [the] draft [guidance].” Denial of 1999
Petition 4; Denial of 2005 Petition 3. FDA asserted its belief that “the current proposed approach
will accomplish” the goal of judicious antibiotic use in livestock “in a more timely and resourceefficient manner than would otherwise be the case.” Denial of 1999 Petition 4; Denial of 2005
Petition 4.

5

The denial letters present no evidence supporting FDA’s professed confidence in
voluntary measures. Nor do the letters mention the steady stream of industry comments
challenging the conclusion on which the Draft Guidance is predicated: that nontherapeutic uses
of antibiotics in livestock threaten human health.
ARGUMENT
I.

Standard of Review
Under FDA regulations, the denial of a citizen petition is final agency action subject to

judicial review. See 21 C.F.R. § 10.45(d). The APA provides that a reviewing court “shall . . .
hold unlawful and set aside agency action, findings, and conclusions found to be . . . arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C.
§ 706(2)(A). Although the court may not “substitute its judgment for that of the agency,” the
court’s review “must be searching and careful.” Natural Res. Def. Council (NRDC) v. EPA, 658
F.3d 200, 215 (2d Cir. 2011) (internal quotation marks omitted). The agency “must examine the
relevant data and articulate a satisfactory explanation for its action including a rational
connection between the facts found and the choice made.” Motor Vehicle Mfrs. Ass’n v. State
Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983) (internal quotation marks omitted).
Additionally, agency action is arbitrary and capricious if the agency has “‘relied on factors which
Congress has not intended it to consider’” or has “‘offered an explanation for its decision that
runs counter to the evidence before the agency, or is so implausible that it could not be ascribed
to a difference in view or the product of agency expertise.’” NRDC, 658 F.3d at 215 (quoting
State Farm, 463 U.S. at 43).
II.

FDA’s Reasons for Denying the Petitions Find No Basis in the Food and Drug Act
The petition denials are “not in accordance with law,” 5 U.S.C. § 706(2)(A), because they

“rest[] on reasoning divorced from the statutory text” of the Food and Drug Act. Massachusetts
6

v. EPA, 549 U.S. 497, 532 (2007). The question whether FDA must withdraw approval for a
previously approved animal drug turns on a scientific judgment about the drug’s safety. FDA
cannot refuse to regulate on the ground that it is pursuing a voluntary program that has no basis
in the statute. Because the petition denials are blind to FDA’s statutory mandate to protect the
public health by promptly removing from the market drugs that are unsafe or not shown to be
safe, they must be set aside. See 5 U.S.C. § 706(2)(A).
A.

FDA’s Refusal to Address the Merits of the Petitions Is Invalid under
Massachusetts v. EPA

The Secretary of HHS, “through the Commissioner” of FDA, 21 U.S.C. § 393(d)(2),
regulates antibiotics used in livestock as “new animal drugs” under section 512 of the Food and
Drug Act, 21 U.S.C. § 360b. The statute directs FDA to withdraw its existing approval of a new
animal drug application if the agency finds that the drug is unsafe or not shown to be safe:
The Secretary shall, after due notice and opportunity for hearing to the applicant,
issue an order withdrawing approval of an application . . . if the Secretary
finds . . . that experience or scientific data show that such drug is unsafe for use
under the conditions of use upon the basis of which the application was
approved . . . ; [or] that new evidence not contained in such application . . .
evaluated together with the evidence available to the Secretary when the
application was approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the application was
approved . . . .
21 U.S.C. § 360b(e)(1)(A)-(B) (emphases added); see also id. § 360b(i) (requiring FDA, upon
withdrawing approval for an animal drug, to “revoke . . . the regulation” setting forth the drug’s
conditions of use). The petitions asked FDA to regulate antibiotics used in livestock under this
provision.
In Massachusetts v. EPA, the Supreme Court invalidated the U.S. Environmental
Protection Agency’s (EPA’s) denial of a rulemaking petition under Clean Air Act section
202(a)(1). 549 U.S. at 510-11, 534-35. That section provides that the EPA Administrator “shall”
7

prescribe standards “applicable to the emission of any air pollutant from any class or classes of
new motor vehicles . . . which in his judgment cause, or contribute to, air pollution which may
reasonably be anticipated to endanger public health or welfare.” 42 U.S.C. § 7521(a)(1)
(emphasis added); see also Massachusetts, 549 U.S. at 506. The petition requested that EPA
regulate greenhouse gases because they constitute air pollution that contributes to climate
change, which endangers public health and welfare. 549 U.S. at 510. EPA denied the petition,
claiming that it did not have the statutory authority to regulate greenhouse gases and that, even if
it did have the authority, it would be unwise to regulate. Id. at 511-12.
In concluding that it would be unwise to regulate, EPA relied on several nonstatutory
grounds. For example, the agency asserted that the regulation of motor vehicle emissions was a
“piecemeal approach” to climate change in conflict with the President’s more “comprehensive
approach,” which relied in part on “nonregulatory programs to encourage voluntary privatesector reductions in greenhouse gas emissions.” Id. at 513.
The Supreme Court rejected the agency’s arguments, ruling that while “EPA no doubt
has significant latitude as to the manner, timing, content, and coordination of its regulations with
those of other agencies,” “once EPA has responded to a petition for rulemaking, its reasons for
action or inaction must conform to the authorizing statute.” Id. at 533. EPA could “avoid taking
further action only if it determine[d] that greenhouse gases do not contribute to climate change”
or provided a “reasonable explanation” for why it could not or would not determine whether they
do. Id. The Court rejected EPA’s “laundry list of reasons not to regulate,” including its “policy
judgments” that existing voluntary programs responded effectively to the threat of global
warming, and that curtailing motor vehicle emissions would be an “inefficient, piecemeal
approach” to address climate change. Id. As the Court explained, it was “evident [EPA’s reasons

8

not to regulate] have nothing to do” with the statutory inquiry whether greenhouse gas emissions
contribute to air pollution that endangers public health, and “[s]till less do they amount to a
reasoned justification for declining to form a scientific judgment.” Id. at 533-34.
The animal drug withdrawal provision of the Food and Drug Act, 21 U.S.C. § 360b(e)(1),
parallels the Clean Air Act provision at issue in Massachusetts, and FDA’s rationales for
denying the petitions echo the justifications the Court rejected in that case. The Food and Drug
Act mandates that FDA withdraw approval for an animal drug if the agency determines that the
drug is “unsafe” or “not shown to be safe.” 21 U.S.C. § 360b(e)(1)(A)-(B). Section 202 of the
Clean Air Act mandates that EPA promulgate emission standards for an air pollutant “[i]f EPA
makes a finding of endangerment.” Massachusetts, 549 U.S. at 533. In both cases, the question
whether the agency must regulate turns on a single factor: the outcome of the agency’s safety
evaluation. The Supreme Court required EPA, when faced with a petition seeking regulation of
greenhouse gases, to “form a scientific judgment” whether an endangerment exists or provide a
“reasonable explanation” for its inability or refusal to do so. See id. at 533-34. Similarly here,
when confronted with petitions seeking regulation of antibiotics in animal feed, FDA must
determine on the merits whether the challenged drug uses have been shown to be safe for human
health or, at the very least, provide an explanation grounded in the statute as to why it cannot or
will not make that determination. 1 See id. at 533, 535.

1

FDA has already made findings that subtherapeutic uses in animal feed of two of the drugs
covered by the petitions, penicillin and tetracyclines, have not been shown to be safe for human
health. See Tetracycline (Chlortetracycline and Oxytetracycline)-Containing Premixes
(Tetracyclines Notice), 42 Fed. Reg. 56,264, 56,288 (Oct. 21, 1977), Sorenson Decl. Ex. B (Dkt.
33-2); Penicillin-Containing Premixes (Penicillin Notice), 42 Fed. Reg. 43,772, 43,772 (Aug. 30,
1977), Sorenson Decl. Ex. A (Dkt. 33-1). These findings are the subject of plaintiffs’ First Claim
for Relief, briefed previously. See Mem. of Law in Supp. of Pls.’ Mot. for Summ. J. 8-13, Oct. 6,
2011 (Dkt. 20).
9

FDA did not conform its conduct to the contours of its authorizing statute. Citing
voluminous science, including studies commissioned and endorsed by FDA itself, the petitions
raised the question whether, under the Food and Drug Act, the challenged drug uses were unsafe
or not shown to be safe and therefore had to be banned. In denying the petitions, FDA did not
answer or confront that question. Instead, it stated a policy preference for pursuing voluntary
reform. The Food and Drug Act nowhere mentions a voluntary approach to reducing the use of a
previously approved drug that is unsafe or not shown to be safe for human health. Rather, it
commands FDA to withdraw approval for such a drug. See 21 U.S.C. § 360b(e)(1)(A)-(B)
(providing that the Secretary “shall . . . issue an order withdrawing approval” upon finding that a
drug use is unsafe or not shown to be safe). Thus, the reasons FDA gave for denying the
petitions, like those tendered by EPA when it refused to determine whether greenhouse gases
endanger the public welfare, are unmoored from the governing statute. Consistent with the
Court’s ruling in Massachusetts, the FDA denials are not in accordance with law and must be
vacated under the APA, 5 U.S.C. § 706(2)(A).
B.

FDA’s Issuance of Voluntary Guidance Cannot Excuse Its Failure to
Conduct the Required Statutory Inquiry

The Food and Drug Act conditions withdrawal of approval for a drug use on an FDA
finding. See 21 U.S.C. § 360b(e)(1). But the grant of limited discretion in the phrase “if the
Secretary finds” is “not a roving license to ignore the statutory text” but rather “a direction to
exercise discretion within defined statutory limits.” See Massachusetts, 549 U.S. at 532-33.
FDA’s issuance of nonbinding recommendations cannot excuse its failure, in response to the
citizen petitions, to make safety findings and then to withdraw approval for animal drugs that are
unsafe or not shown to be safe. The agency’s policy judgments about the effectiveness of
voluntary approaches versus regulation are irrelevant to the statutory question whether the
10

evidence proves that the challenged drug uses are “unsafe” or “not shown to be safe.” See id. at
533-34; 21 U.S.C. § 360b(e)(1)(A)-(B).
Voluntary guidelines are not equivalent to binding regulations. See Massachusetts, 549
U.S. at 513 (noting that voluntary programs are “not actual regulation”). An agency “ordered by
Congress to promulgate binding regulatory requirements may not issue a non-binding policy
statement that encourages but does not compel action.” Pub. Citizen, Inc. v. Nat’l Highway
Traffic Safety Admin., 374 F.3d 1251, 1261 (D.C. Cir. 2004) (summarizing holding of Pub.
Citizen v. Nuclear Regulatory Comm’n, 901 F.2d 147, 157 (D.C. Cir. 1990)). For example,
where EPA had found that certain chemicals were subject to a mandatory testing regime under
the Toxic Substances Control Act, the court rejected the agency’s “negotiation and acceptance of
voluntary testing agreements by the manufacturers.” NRDC v. EPA, 595 F. Supp. 1255, 1261
(S.D.N.Y. 1984). Finding “no support for EPA’s decision to utilize negotiated testing agreements
instead of the statutorily-prescribed initiation of rulemaking proceedings either on the face of the
statute or based on some vague assertion of agency discretion,” the court held that “[t]he agency
charged with implementing the statute is not free to evade the unambiguous directions of the law
merely for administrative convenience.” Id. (internal quotation marks omitted).
The same constraint applies to FDA. The agency’s protestation that formal withdrawal
proceedings “can consume extensive periods of time and Agency resources,” Denial of 1999
Petition 3; Denial of 2005 Petition 2-3, is irrelevant because formal withdrawal proceedings are
what Congress has ordered. If a drug is unsafe or not shown to be safe, the Food and Drug Act
directs FDA to remove the drug from the market, not simply to recommend that its use be
curtailed. “To the extent that this constrains agency discretion to pursue other priorities . . . , this
is the congressional design.” Massachusetts, 549 U.S. at 533.

11

C.

The Petition Denials Are Blind to the Purpose of the Food and Drug Act

FDA’s petition denials are more than unmoored from the plain language of the Food and
Drug Act; they are blind to the Act’s purpose and legislative history. The animal drug
withdrawal provision at issue here, 21 U.S.C. § 360b(e)(1), mirrors the provision for withdrawal
of human drugs, id. § 355(e)(1)-(2), and FDA has recognized that the same legislative history
underlies both provisions. See Withdrawal of Approval of the New Animal Drug Application for
Enrofloxacin in Poultry, No. 2000N-1571, at 86 n.122 (FDA July 27, 2005) (final decision of
Comm’r), Ex. N to Decl. of Amy A. Barcelo, Jan. 9, 2012 (Barcelo Decl.) (Dkt. 44-14). The
purpose of both provisions is to ensure the prompt removal from the market of drugs that are
unsafe or not shown to be safe. Congress mandated withdrawal of approval for drugs “not shown
to be safe” to “permit the prompt removal from the market of such drugs when new evidence . . .
establishes that the drug should not have been cleared for safety in the first instance.” See Drug
Amendments of 1962, Pub. L. No. 87-781, § 102(d), 76 Stat. 780, 781-82; S. Rep. No. 87-1744,
at 1 (1962), reprinted in 1962 U.S.C.C.A.N. 2884, 2884 (emphasis added). Rapid removal from
the market of drugs not shown to be safe serves the Food and Drug Act’s “overriding purpose”:
“protect[ing] the public health.” Nutritional Health Alliance, 318 F.3d at 98 (quoting Nova
Scotia Food Prods. Corp., 568 F.2d at 246); see also 21 U.S.C. § 393(b)(1)-(b)(2)(B) (setting
forth FDA’s mission to “promote the public health by promptly and efficiently reviewing clinical
research and taking appropriate action on the marketing of regulated products in a timely
manner” and to “protect the public health by ensuring that . . . human and veterinary drugs are
safe and effective”).
By failing to rule on the substantive question raised by the petitions and then prohibit
drug uses that are unsafe or not shown to be safe, FDA has been “blind to the nature of [its]
mandate.” Am. Horse Prot. Ass’n v. Lyng, 812 F.2d 1, 7 (D.C. Cir. 1987) (holding that an agency
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action reflecting a compromise showing solicitude for the interests of horse owners, in the face
of a statute meant only to protect horses, demonstrated that the agency was “blind to the nature
of [the agency’s] mandate from Congress”). The petition denials betray an undue focus on
“working with . . . stakeholders in developing a strategy to address antimicrobial resistance
concerns,” Denial of 1999 Petition 4; Denial of 2005 Petition 4, at the expense of the agency’s
mandate to protect public health by removing unsafe and potentially unsafe drugs from the
market. Cf. W. Harlem Envtl. Action v. EPA, 380 F. Supp. 2d 289, 296 (S.D.N.Y. 2005) (“EPA is
not in the business of reaching consensus with the ‘stakeholders’ it regulates.”). Because the
petition denials flout the purpose and legislative history of the Food and Drug Act, they are “not
in accordance with law” and must be vacated pursuant to the APA, 5 U.S.C. § 706(2)(A).
III.

FDA’s Reasons for Denying the Petitions Are Arbitrary
FDA has failed to draw a rational connection between its professed safety concerns

regarding livestock antibiotic use and its decision not to regulate. Moreover, in denying the
petitions, FDA presented no factual evidence that the voluntary approach the agency is pursuing
as an extrastatutory alternative to regulation will achieve the public health protection mandated
by the Food and Drug Act. Indeed, comments by industry representatives indicate their antipathy
to FDA’s conclusion that nontherapeutic antibiotic use in livestock jeopardizes human health.
This arbitrary treatment of the citizen petitions presents an independent ground for invalidating
the agency’s actions. See 5 U.S.C. § 706(2)(A).
A.

FDA Pronouncements Convey Agreement with the Premise of the Petitions

This is an egregious case of agency dereliction not only because public health is at stake,
but because FDA has effectively conceded that science supports the relief the petitioners seek. A
consistent stream of FDA pronouncements indicates the agency’s agreement with the petitions’
central premise that nontherapeutic antibiotic use in livestock endangers human health. See, e.g.,
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Gov’t Resp. to Pls.’ Statement of Facts ¶¶ 4 (detailing the dangers of antibiotic-resistant
infections), 6-8 (characterizing antibiotic resistance as a “serious public health threat”), 23
(admitting that antibiotic use in livestock leads to the development of antibiotic-resistant bacteria
that can be and have been transferred to humans), 32-33 (concluding that using medically
important antibiotics for livestock production purposes “is not in the interest of protecting and
promoting the public health”), Jan. 9, 2012 (Dkt. 45). In the petition denials themselves, FDA
says it shares the petitioners’ concerns about the pernicious effects of using antibiotics for
livestock production purposes. See Denial of 1999 Petition 1; Denial of 2005 Petition 1. The
substance of the agency’s stated views supports the petitions, but the agency denied the petitions
anyway.
FDA “considers an antimicrobial new animal drug to be ‘safe’ if the agency concludes
that there is ‘reasonable certainty of no harm to human health’ from the proposed use of the drug
in food-producing animals.” Draft Guidance No. 209, at 13. Given the current state of the
science, FDA has not explained how it could draw such a conclusion regarding the
nontherapeutic use of medically important antibiotics in livestock. For example, as recently as
2010, the Centers for Disease Control and Prevention (CDC), FDA’s sister division within HHS,
confirmed that there is “strong scientific evidence of a link between antibiotic use in food
animals and antibiotic resistance in humans,” resulting in “adverse human health consequences.”
Letter from Thomas R. Frieden, Director, CDC, to the Honorable Frank Pallone, Jr., Chairman,
Subcommittee on Health, House Committee on Energy and Commerce (July 13, 2010), Sorenson
Decl. Ex. W (Dkt. 33-23); Gov’t Resp. to Pls.’ Statement of Facts ¶ 38. CDC’s statement
reinforces findings by WHO, the Institute of Medicine, GAO, and HHS, as well as FDA’s own
finding in Draft Guidance No. 209: “the overall weight of evidence available to date [2010]

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supports the conclusion that using medically important antimicrobial drugs for production
purposes is not in the interest of protecting and promoting the public health.” Draft Guidance No.
209, at 13; Gov’t Resp. to Pls.’ Statement of Facts ¶¶ 35-37, 39. If such drug uses are “not in the
interest of protecting and promoting the public health,” then they are “not shown to be safe.” See
21 U.S.C. § 360b(e)(1)(B).
By FDA’s own admission, then, the Food and Drug Act requires the action the petitions
seek: rescission of approvals for nontherapeutic uses of medically important antibiotics in
livestock. The petition denials are therefore arbitrary. See Ass’n of Irritated Residents v. EPA,
Nos. 09-71383, 09-71404, 2012 WL 251912, at *6 (9th Cir. Jan. 27, 2012) (holding that, where
EPA’s obligation to take action is triggered by a finding that a state air pollution plan is
substantially inadequate, ignoring “strong evidence” “indicating an existing [plan] might be
substantially inadequate and choos[ing] to do nothing” is arbitrary and capricious). FDA must
explain how its decision not to regulate can be squared with its own safety findings. See Am.
Lung Ass’n v. EPA, 134 F.3d 388, 388, 391-93 (D.C. Cir. 1998) (holding that EPA had not
adequately explained its decision not to strengthen air quality standards for sulfur dioxide (SO2),
in light of agency findings suggesting that as many as 41,500 asthmatics experience “substantial
physical effects . . . from exposure to short-term, high-level SO2 bursts” each year). The petition
denials offer no such explanation. Because FDA has failed to articulate a “rational connection
between the facts found and the choice made,” State Farm, 463 U.S. at 43 (internal quotation
marks omitted), the petition denials must be set aside.
B.

FDA Presents No Evidence Supporting the Efficacy of Voluntary Measures

It is axiomatic that administrative agencies must support their decisions with credible
reasons. See State Farm, 463 U.S. at 43 (“[T]he agency must examine the relevant data and
articulate a satisfactory explanation for its action . . . .”). In denying the petitions, FDA explained
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that it is “currently pursuing other alternatives to address the issue of antimicrobial resistance
related to the production use of antimicrobials in animal agriculture” because withdrawing
approvals as outlined in the Food and Drug Act “would take many years and would impose
significant resource demands on the Agency.” Denial of 1999 Petition 3; Denial of 2005 Petition
2-3. FDA’s alternative approach is to suggest voluntary actions by industry to reduce the use of
antibiotics, pursuant to Draft Guidance No. 209. Id.
Assuming for the purpose of this argument the legal legitimacy of the agency’s approach,
FDA must provide evidence supporting its professed belief that voluntary measures will result in
prompt removal from the market of drug uses that are unsafe or not shown to be safe for human
health. The denial letters provide no such evidence. Instead, FDA offers a veritable primer in
equivocation: “Based on feedback this Agency has received following the issuance of draft
[Guidance] #209, FDA believes that the animal pharmaceutical industry is generally responsive
to the prospect of working cooperatively with the Agency to implement the principles
recommended in” the Draft Guidance. Denial of 1999 Petition 4; Denial of 2005 Petition 3. FDA
does not specify the feedback that feeds its belief that industry is generally responsive to the
prospect of cooperation.
FDA goes on to write that it “intends to work with sponsors who approach FDA and are
interested in working cooperatively with the Agency to phase out production uses of medically
important” antibiotics. Denial of 1999 Petition 4; Denial of 2005 Petition 3. The denial letters
include no evidence that any drug sponsor has so approached FDA. Indeed, industry comments
on Draft Guidance No. 209 tended to question whether the use of antibiotics to promote animal
production poses any threat at all to human health. For instance, the Animal Health Institute, the
national trade association representing manufacturers of animal drugs, complained that “the

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proposed guidance does not claim existing uses are unsafe, but rather not judicious. This
suggests current science cannot implicate existing indications for growth promotion as unsafe
uses of antibiotics, but certain opinion leaders believe the use is inappropriate.” Comments of
Animal Health Inst., Document No. FDA-2010-D-0094-0403, at 1-2 (Aug. 27, 2010), Bernard
Decl. Ex. C. The association then cited a “listing of key publications that do not support the
contention that animal use of antibiotics necessarily represents a significant risk to human
health.” Id. at 2. Alpharma, an animal drug manufacturer, “maintain[ed] [that] approved uses of
our products—which help to safely and efficiently provide high quality, affordable meat, milk
and eggs for a growing world population—are in fact in the interest of protecting and promoting
public health; i.e., these are judicious uses.” Comments of Alpharma, LLC, Document No. FDA2010-D-0094-0392, at 1-2 (Aug. 25, 2010), Bernard Decl. Ex. D. Similarly, the American Farm
Bureau Federation opined that “antibiotic use in animals is not a major risk to human health.”
Comments of Am. Farm Bureau Fed’n, Document No. FDA-2010-D-0094-0386, at 3 (Aug. 26,
2010), Bernard Decl. Ex. E.
Given the comments cited above; the pharmaceutical industry’s economic interest in
maximizing the use of the antibiotics it markets; livestock producers’ economic interest in
promoting weight gain and feed efficiency; and FDA’s passive, work-with-sponsors-whoapproach-us stance, there is no reason in logic or fact to credit the agency’s professed (and
counterintuitive) belief in the efficacy of the purely voluntary, unenforceable measures it has
offered. The petition denials themselves contain no such supporting evidence. That renders them
arbitrary. It is FDA’s responsibility to explain the “factual basis for its decision.” Detsel by
Detsel v. Sullivan, 895 F.2d 58, 63 (2d Cir. 1990) (quoting Bowen v. Am. Hosp. Ass’n, 476 U.S.

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610, 626-27 (1986) (plurality opinion)). Courts “can hardly accept an agency’s reliance on
‘evidence’ that is itself mere speculation.” Id. at 64.
IV.

Plaintiffs Have Standing to Pursue this Claim
To establish Article III standing, an associational plaintiff must show that (1) its members

would have standing to sue in their own right; (2) the interests it seeks to protect are germane to
its organizational purposes; and (3) the litigation will not require its members’ individual
participation. See Hunt v. Wash. State Apple Adver. Comm’n, 432 U.S. 333, 343 (1977); Bldg. &
Constr. Trades Council v. Downtown Dev., Inc., 448 F.3d 138, 144 (2d Cir. 2006). For the
following reasons, and the reasons set forth in the memorandum supporting their initial motion
for summary judgment, plaintiffs satisfy this three-part test. See Mem. of Law in Supp. of Pls.’
Mot. for Summ. J. 19-22, Oct. 6, 2011 (Dkt. 20). 2
This suit is germane to plaintiffs’ institutional missions. See Decl. of Michael F. Jacobson
(CSPI) ¶¶ 2-4, June 29, 2011 (Dkt. 25); Decl. of Linda Lopez (NRDC) ¶¶ 5-7, July 5, 2011 (Dkt.
28); Decl. of Jennifer Norris (UCS) ¶ 6, Sept. 28, 2011 (Dkt. 31); Decl. of Robert Weissman
(Public Citizen) ¶ 5, Sept. 28, 2011 (Dkt. 34). Because plaintiffs seek only declaratory relief and
an order compelling agency action, the participation of individual members is not required. See
Bldg. & Constr. Trades Council, 448 F.3d at 150.
Members of NRDC, CSPI, Public Citizen, and UCS would have standing on their own
because they suffer concrete, particularized, and imminent “injury in fact” that is fairly traceable
to FDA’s denial of the petitions and is likely to be redressed by a favorable judicial decision.

2

As the other plaintiffs have standing, FACT, which is not a membership organization, need
not show standing. See Rumsfeld v. Forum for Academic & Institutional Rights, Inc., 547 U.S.
47, 52 n.2 (2006). Nonetheless, FDA’s regulations provide that an “interested person” that
“submits a petition” has “standing to obtain judicial review” of the agency’s final decision on the
petition. 21 C.F.R. §§ 10.3, 10.45(d)(1)(ii). FACT signed both petitions.
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Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180-81 (2000).
When a litigant “is vested with a procedural right”—here, the right to petition FDA pursuant to
21 C.F.R. § 10.25—the redressability prong of the standing inquiry is met “if there is some
possibility that the requested relief will prompt the injury-causing party to reconsider the
decision that allegedly harmed the litigant.” Massachusetts, 549 U.S. at 518.
Plaintiffs’ members include consumers who face an increased risk of contracting a drugresistant infection as a result of handling or eating meat or poultry products from animals that are
given routine doses of medically important antibiotics. See Baur v. Veneman, 352 F.3d 625,
634 (2d Cir. 2003); Friends of the Earth, Inc. v. Gaston Copper Recycling Corp., 204 F.3d 149,
160 (4th Cir. 2000) (en banc); Decl. of Jasanna Britton (Britton Decl.) ¶¶ 6-7, Sept. 30, 2011
(Dkt. 22); Decl. of Amanda J. Fleming (Fleming Decl.) ¶¶ 7-8, Sept. 28, 2011 (Dkt. 23); Decl. of
Anne Kapuscinski (Kapuscinski Decl.) ¶¶ 8-9, Oct. 3, 2011 (Dkt. 27); Decl. of Ilana SlaffGalatan ¶¶ 4-5, 8, Sept. 28, 2011 (Dkt. 32); see also Pls.’ Statement of Material Facts in Supp. of
Mot. for Summ. J. (First Statement of Facts) ¶¶ 26-28, Oct. 6, 2011 (Dkt. 21) (citing 2009 data
on percentages of retail meat contaminated with antibiotic-resistant bacteria). In addition,
because of their reasonable concerns about the risks they face, plaintiffs’ members have reduced
their meat consumption or spend more time or money than they otherwise would to buy meat
from animals raised without antibiotics. Britton Decl. ¶¶ 4-6; Fleming Decl. ¶¶ 3-6; Kapuscinski
Decl. ¶¶ 4-6; Decl. of Melissa Melum (Melum Decl.) ¶¶ 4-7, Oct. 3, 2011 (Dkt. 29); Decl. of
Rachel Mlinarchik ¶¶ 3-6, Sept. 28, 2011 (Dkt. 30). These injuries provide an independent basis
for standing, in addition to the increased risk of harm faced by plaintiffs’ members. See Laidlaw,
528 U.S. at 181-83; see also Amnesty Int’l USA v. Clapper, 638 F.3d 118, 133-34 (2d Cir. 2011).

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Plaintiffs’ members’ injuries are directly traceable to FDA’s denial of the petitions. Until
FDA withdraws approvals for nontherapeutic uses of medically important antibiotics in
livestock, these drug uses will persist, generating bacteria that are resistant to life-saving drugs.
See First Statement of Facts ¶ 25. A favorable judicial decision would redress plaintiffs’ injuries
because it would require FDA to reconsider the petitions. See Massachusetts, 549 U.S. at 517-18.
Were FDA to grant the petitions and withdraw approvals for antibiotic uses that are unsafe or not
shown to be safe, the prevalence of bacteria in livestock with resistance to these drugs would
stop increasing, and would likely decrease. See First Statement of Facts ¶¶ 42-43. As a result,
plaintiffs’ members would face a reduced risk of exposure to drug-resistant bacteria from
consuming or handling meat products. They would have less need to alter their behavior to avoid
these risks. See Britton Decl. ¶ 8; Fleming Decl. ¶ 9; Kapuscinski Decl. ¶¶ 5, 9; Melum Decl. ¶ 7.
CONCLUSION
For the reasons detailed above, plaintiffs urge the Court to invalidate the petition denials
and remand the matter to FDA with instructions promptly to address the petitions on their merits.

Dated: February 21, 2012

Respectfully submitted,
s/ Mitchell S. Bernard
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
[phone]
[phone] (fax)
[e-mail]

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Avinash Kar, admitted pro hac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th Floor
San Francisco, California 94104
[phone]
[phone] (fax)
[e-mail]; [e-mail]
Counsel for Plaintiffs
Of Counsel for Plaintiff Center for Science
in the Public Interest:
Stephen Gardner (SG 3964)
Center for Science in the Public Interest
5646 Milton Street, Suite 211
Dallas, Texas 75206
[phone]
[phone] (fax)
[e-mail]

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