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

• Decision Date: 24 July 2014
• Docket Number: Docket No. 12-3607-cv(CON),Docket No. 12-2106-cv(L)
• Parties: NATURAL RESOURCES DEFENSE COUNCIL, INC., CENTER FOR SCIENCE IN THE PUBLIC INTEREST, FOOD ANIMAL CONCERNS TRUST, PUBLIC CITIZEN, INC., UNION OF CONCERNED SCIENTISTS, INC., Plaintiffs-Appellees, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET HAMBURG, in her official capacity as Commissioner, United States Food and Drug Administration, CENTER FOR VETERINARY MEDICINE, BERNADETTE DUNHAM, in her official capacity as Director, Center for Veterinary Medicine, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, KATHLEEN SEBELIUS, in her official capacity as Secretary, United States Department of Health and Human Services, Defendants-Appellants.
• Court: U.S. Court of Appeals — Second Circuit

NATURAL RESOURCES DEFENSE COUNCIL, INC.,

CENTER FOR SCIENCE IN THE PUBLIC INTEREST,

FOOD ANIMAL CONCERNS TRUST, PUBLIC CITIZEN, INC., UNION

OF CONCERNED SCIENTISTS, INC., Plaintiffs-Appellees, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET HAMBURG, in her official capacity as Commissioner, United States Food and Drug Administration,

CENTER FOR VETERINARY MEDICINE, BERNADETTE DUNHAM, in her official capacity

as Director, Center for Veterinary Medicine, UNITED STATES DEPARTMENT

OF HEALTH AND HUMAN SERVICES, KATHLEEN SEBELIUS,

in her official capacity as Secretary, United States Department

of Health and Human Services, Defendants-Appellants.

Docket No. 12-2106-cv(L)

Docket No. 12-3607-cv(CON)

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

August Term, 2012

Argued: February 8, 2013

Decided: July 24, 2014

Before:

KATZMANN, Chief Judge, LYNCH, Circuit Judge, and FORREST, District Judge^*

On appeal from entry of summary judgment in the United States District Court for the Southern District of New York (Theodore H. Katz and James C. Francis IV, Magistrate Judges), defendants challenge the district court's conclusion that the United States Food and Drug Administration ("FDA") is required by 21 U.S.C. § 360b(e)(1) to proceed with hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed and that the FDA's decision denying two citizen petitions urging it to hold such hearings was arbitrary or capricious within the meaning of 5 U.S.C. § 706(2).

REVERSED.

Chief Judge Katzmann dissents in a separate opinion.

JENNIFER A. SORENSON (Mitchell S. Bernard, Avinash Kar, on the brief), Natural Resources Defense Council, New York, New York, for Plaintiffs-Appellees.

ELLEN LONDON (Amy A. Barcelo, Benjamin H. Torrance, Assistant United States Attorneys, David J. Horowitz, Deputy General Counsel, Elizabeth H. Dickinson, Chief Counsel, Food and Drug Division, Eric M. Blumberg, Deputy Chief Counsel, Litigation, Thomas J. Cosgrove, Associate Chief Counsel, Department of Health and Human Services, on the brief), for Preet Bharara, United States Attorney for the Southern District of New York, New York, New York, for Defendants-Appellants.

GERARD E. LYNCH, Circuit Judge:

For nearly seventy years, antibiotics have provided dramatic medical advances in the treatment of bacterial infections.¹ For nearly as long, scientists have been concerned about the problem of antibiotic resistance. Through repeated exposure to antibiotics, some strains of bacteria develop resistance or immunity to particular antibiotics. Such resistance presents a serious threat tohuman health. Infections in humans caused by antibiotic-resistant bacteria result, on average, in longer hospital stays, worse side effects of treatment, and a greater likelihood of death. In an effort to forestall the development of antibiotic-resistant strains of bacteria, doctors exercise restraint in prescribing antibiotics and are careful to direct patients to use antibiotics only as prescribed.

However, for each dose of antibiotics given to humans for medical purposes, four doses are given to livestock for non-medical reasons to encourage faster, healthier growth. In 2009, 28.8 million pounds of antibiotics were administered to animals raised for food, most of it through animal feed. Unfortunately, research shows that bacteria that develop resistance to antibiotics used in animal feed can transfer to human beings and pose a risk to human health. For that reason, various public-interest organizations have sought to force the Food and Drug Administration ("FDA") to prohibit the use of certain antibiotics in animal feed. This case arises from one such effort.²

In this lawsuit, the plaintiff organizations contend that the FDA is required by 21 U.S.C. § 360b(e)(1) to proceed with hearings to determine whether towithdraw approval for the use of penicillin and tetracyclines in animal feed, and that the FDA's denial of two citizen petitions demanding such hearings was arbitrary or capricious within the meaning of 5 U.S.C. § 706(2). The district court accepted plaintiffs' contention. Because we conclude that plaintiffs and the district court are incorrect, we reverse the judgment of the district court.

BACKGROUND

I. FDA Regulation of Animal Feed Antibiotics

The FDA has statutory authority to regulate new animal drugs³ introduced into interstate commerce. See 21 U.S.C. § 360b(a)(1). New animal drugs are prohibited unless specifically approved by the FDA following a new animal drug application ("NADA") made by a sponsor, which is usually the drug manufacturer that produced the drug.⁴ Because antibiotics can be used in animal feed to produce bigger animals that grow faster on less food, many drug manufacturers have sought approval to sell antibiotics for use in animal feed.

In 1951, the FDA approved the first use of antibiotics as ingredients in animal feed to encourage animal growth. Two years later, it approved the first use of antibiotics as drugs in animal feed. But by the late 1960s, the FDA "became concerned about the safety to man and animals of subtherapeutic antibiotic use" both as a general matter and specifically in the context of animal feed.⁵ See Tetracycline (Chlortetracycline and Oxytetracycline)-Containing Premixes: opportunity for Hearing, 42 Fed. Reg. 56264, 56266 (oct. 21, 1977) ("Tetracycline NOOH"). Thus began the decades-long investigation of the danger posed by such use, and the concern about human safety has persisted ever since.

In 1970, prompted by a report published by the United Kingdom's Joint Committee on the Use of Antibiotics in Animal Husbandry and Veterinary Medicine, the FDA instituted a Task Force to study the problem. In 1972, the Task Force published its report, concluding that: (1) the use of antibiotics in "subtherapeutic amounts" favors the selection of antibiotic-resistant bacteria; (2)animals treated with such doses of antibiotics can serve as hosts for resistant bacteria, which can then be transferred to humans; (3) the prevalence of resistant bacteria had increased; and (4) resistant bacteria had been found in meat and meat products intended for human consumption. The Task Force's report proposed withdrawing approval for all then-approved subtherapeutic uses of antibiotics unless the manufacturers of the drugs submitted evidence regarding the safety and effectiveness of the drugs as used in animal feed.

In 1977, after receiving the requested information from the drug manufacturers and the recommendation of the Animal Feeds Subcommittee of the National Advisory Food and Drug Committee, the FDA's Bureau of Veterinary Medicine ("CVM")⁶ issued notices of opportunity for hearing ("NooHs") with respect to both penicillin and tetracyclines, another family of antibiotics. Penicillin-Containing Premixes: Opportunity for Hearing, 42 Fed. Reg. 43772 (Aug. 30, 1977) ("Penicillin NOOH"); Tetracycline NOOH, 42 Fed. Reg. 56264 (Oct. 21, 1977). The notices detailed the history of subtherapeuticantibiotic drug use and the scientific data on the safety and effectiveness of such use, and concluded that the drug manufacturers had "failed to resolve the basic safety questions that underlie the subtherapeutic use of [antibiotics] in animal feed." The Penicillin NOOH went on to state that the Director of the CVM had

conclude[d], on the basis of new information before him with respect to these drug products, evaluated together with the evidence available to him when they were originally approved, that the drug products are not shown to be safe under the conditions of use prescribed, recommended, or suggested in their labeling. The evidence, in fact, indicate[d] that such penicillin use may be unsafe, particularly if the higher or therapeutic levels of penicillin should be used as substitutes for the levels currently used subtherapeutically.

42 Fed. Reg. at 43792. The Tetracycline NOOH stated that the use of such drugs was safe only for a list of specific and strictly limited uses. 42 Fed. Reg. at 56287.

Less than a year after the NOOHs were issued, congressional appropriations committees set aside funds so that the National Academies of Sciences ("NAS") could conduct further research on the safety and effectiveness of antibiotics in animal feed. The report issued by the House Appropriations Committee included thinly veiled suggestions that the FDA not go forward with the hearing process until the research was completed. See H.R. Rep. No. 95-1290,at 99 (1978). The NAS report, which was largely inconclusive but found that "subtherapeutic use of antimicrobials does increase the prevalence of resistance among the E coli and Salmonella of treated animals," also recommended that additional studies be conducted. National Academy of Sciences, The Effects on Human Health of Subtherapeutic Use of Antimicrobials in Animal Feed xiv (1980), http://www.nap.edu/catalog.php?record_id=21.

Two years later, the House committee reiterated its desire to see further evidence before approving the hearing process. A year after that, the Senate Committee on Appropriations noted that the additional studies recommended by the NAS had not yet been conducted and concluded that the "FDA will be expected to continue to hold in abeyance any implementation of its proposal pending the final results of the above research and evidentiary hearings." S. Rep. No. 97-248, at 79 (1981).

In 1981, several industry groups petitioned the FDA to withdraw the 1977 NOOHs. They also sought approval for new uses of antibiotics. On February 1, 1983, the FDA formally denied the petitions. Penicillin and Tetracycline (Chlortetracycline and Oxytetracycline) in Animal Feeds; Denial of Petitions, 48 Fed. Reg. 4544, 4556 (Feb. 1, 1983). The published notice accompanying thedenials stated that "the Director [of the CVM] does not have any less concern at present about the safety issues that prompted adoption of [the NOOHs]. The Director has not changed his earlier conclusion that...