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

Filing 19

MOTION for Summary Judgment. 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..(Sorenson, Jennifer)

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.
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11 CIV 3562 (THK)
ECF Case

PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT
Pursuant to Rule 56 of the Federal Rules of Civil Procedure, plaintiffs Natural Resources
Defense Council, Center for Science in the Public Interest, Food Animal Concerns Trust, Public
Citizen, and Union of Concerned Scientists hereby move for summary judgment on the basis that
there is no genuine issue of material fact, and plaintiffs are entitled to judgment as a matter of
law. Defendants have violated (1) the Federal Food, Drug, and Cosmetic Act (Food and Drug
Act), 21 U.S.C. § 360b(e)(1)(B), by failing to withdraw approvals for subtherapeutic uses of

penicillin and tetracyclines in animal feed and (2) the Administrative Procedure Act (APA), 5
U.S.C. § 555(b), by delaying unreasonably in ruling on plaintiffs’ citizen petitions.
The Food and Drug Act requires the U.S. Food and Drug Administration (FDA) to
withdraw approval of an animal drug if the agency finds that the drug is not shown to be safe for
human health. More than three decades ago, FDA found that certain subtherapeutic uses of
penicillin and tetracyclines in animal feed were not shown to be safe, because they promoted the
development of antibiotic-resistant bacteria that could be transferred to humans. FDA has never
retracted its findings, nor could it, consistent with current science and the agency’s own
pronouncements. Yet, despite the statutory requirement that it do so, FDA has not withdrawn its
approvals for penicillin and tetracyclines in animal feed. By failing to withdraw these approvals,
FDA has unlawfully withheld agency action. See APA, 5 U.S.C. § 706(1).
Several of the plaintiffs in this action submitted citizen petitions to FDA in 1999 and
2005, requesting that the agency withdraw approvals for nontherapeutic uses of antibiotics in
livestock if those antibiotics are also important to human medicine. Twelve and six years later,
the agency has not ruled on either petition. FDA’s delay in ruling on the plaintiffs’ petitions is
unreasonable. See id.
In support of this motion, plaintiffs submit the accompanying (1) memorandum of law in
support of plaintiffs’ motion for summary judgment; (2) statement of material facts as to which
there is no genuine dispute; (3) Declaration of Jasanna Britton; (4) Declaration of Amanda J.
Fleming; (5) Declaration of Dennis Haller; (6) Declaration of Michael F. Jacobson; (7)
Declaration of Max Kahn, and attached exhibit; (8) Declaration of Anne Kapuscinski; (9)
Declaration of Linda Lopez; (10) Declaration of Melissa Melum; (11) Declaration of Rachel
Mlinarchik; (12) Declaration of Jennifer Norris; (13) Declaration of Ilana Slaff-Galatan; (14)

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Declaration of Jennifer A. Sorenson, and attached exhibits; (15) Declaration of Robert
Weissman; and (16) Declaration of Richard Wood.

Dated: October 6, 2011

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

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