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

Filing 75

COUNTER STATEMENT TO 67 Rule 56.1 Statement. 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’ RESPONSE TO THE GOVERNMENT’S STATEMENT OF
UNDISPUTED MATERIAL FACTS PURSUANT TO LOCAL CIVIL RULE 56.1
REGARDING PLAINTIFFS’ THIRD CLAIM FOR RELIEF
Plaintiffs respond as follows to the Statement of Undisputed Material Facts Pursuant to
Local Civil Rule 56.1 submitted by Defendants on March 21, 2012:
1.
The administrative record of the citizen petitions: (1) filed with FDA on March 9,
1999, by plaintiffs Center for Science in the Public Interest, Food Animal Concerns Trust
(“FACT”), Public Citizen, Inc., and Union of Concerned Scientists, Inc. (“UCS”) and (2) filed
with FDA on April 7, 2005, by plaintiffs FACT and UCS submitted a citizen petition to FDA
(collectively, the “Citizen Petitions”), filed in this action by the Government on March 21, 2012;
under the Certification of Karen Kennard, Division of Dockets Management, executed on March
20, 2012, constitutes the administrative record upon which FDA denied the Citizen Petitions.

CONTROVERTED. For the reasons set forth in their accompanying Motion to
Complete the Administrative Record, plaintiffs request an order that the administrative record be
completed with the industry comments filed as Exhibits C, D, and E to the Declaration of
Mitchell S. Bernard, Feb. 21, 2012 (Dkts. 59-3, 59-4, 59-5).

Dated: April 2, 2012

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