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

Filing 62

STIPULATION AND ORDER: IT IS HEREBY ORDERED THAT: Any objection to the production and use of the Comments in connection with this litigation on the ground that they are protected by the Privacy Act of 1974, 5 U.S.C. § 552a, is overruled. See 5 U.S.C. § 552a(b)(II). The Government will not include the Comments in the administrative record for the Petition Response that it files with the Court on March 21, 2012. The Government will serve Plaintiffs with a copy of the Comments on March 21, 2012. If Plaintiffs wish to rely on any of the Comments in support of their motion for summary judgment regarding their claim brought in the Supplemental Complaint or in opposition to the Government's motion for summary judgment on that same claim, they will notify the Government, at least 3 business days in advance of a court filing, of their intent to rely on such Comments. Prior to Plaintiffs' filing, the Government will redact from those Comments on which Plaintiffs intend to rely any non-releasable private information. If the Government does not timely redact private information from the Comments on which Plaintiffs wish to rely, or if there is any dispute over the extent of a proposed redaction, Plaintiffs may file the unredacted Comments under seal; as further set forth in this Stipulation and Order. (Signed by Magistrate Judge Theodore H. Katz on 3/21/2012) (mro)

PREET BHARARA
United States Attorney for the
Southern District of New York
By: AMY A. BARCELO
Assistant United States Attorney
86 Chambers Street, Third Floor
New York, New York 10007
Telephone: [phone]
Facsimile: [phone]
Email: [e-mail]

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UNITED STATES DISTRICT COURT
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 UNlON OF
CONCERNED SCIENTISTS, INC.,
Plaintiffs,

v.

11 Civ. 3562 (THK
ECF Case
STIPULATIONAN" ORDER

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; and KATHLEEN
SEBELIUS, in her official capacity as
Secretary, United States Department of
Health and Human Services,

WHEREAS on May 25, 2011, plaintiffs Natural Resources DefenaeCouncil, Inc., Center
for Science in the Public Interest, Food Animal Concerns Trust, Public Ci '~en, Inc. and Union
of Concerned Scientists (collectively, "Plaintiffs") commenced this action afainst defendants the

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United States Food and Drug Administration; Margaret Hamburg, in her.o ficial capacity as
Commissioner of Food and Drug; Center for Veterinary Medicine; Bernad tte Dunham, in her
official capacity as Director, Center for Veterinary Medicine; United State
Health and Human Services; and Kathleen Sebelius, in her official capaci

as Secretary, United

States Department of Health and Human Services (collectively, the "Gove

ent").

WHEREAS on February 2, 20 I 2, Plaintiffs filed the First Supplem ntal Complaint (the
"Supplemental Complaint");
WHEREAS the First Supplemental Complaint challenges Gove

ent's November 7,

20 I I responses to two citizen petitions filed by several of the plaintiffs in 999 and 2005 that
requested that the Government withdraw approval for certain uses of certa n antibiotics in
livestock (the "Petition Responses");
WHEREAS the Government's motion in support of its motion for ummary judgment on
the claim brought in the Supplemental Complaint and the administrative r cord for the Petition
Responses is due on March 21, 2012;
WHEREAS the administrative record for the Petition Responses i

ludes more than

17,000 public comments to the two citizen petitions that are the subject of he Petition Responses
(the "Comments");
WHEREAS the Government believes that the Comments are not

aterial to any issue in

the litigation;
WHEREAS some of the infonnation contained in the Comments ( uch as personal
medical history and other private infonnation) may be protected by the
U.S.C. § 552a, orother federal law;

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. acy Act of 1974, 5

WHEREAS, it appears that the disclosure of such Comments is in t~e interests of justice;

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and

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WHEREAS pursuant to 21 C.F.R. § 20.86 the Food and Drug Administration is required
to take appropriate measures to reduce disclosure of certain information cohtained in the
Comments,
IT [S HEREBY ORDERED THAT:
1.

Any objection to the production and use of the Comments in connection

with this litigation on the ground that they are protected by the Privacy Act of 1974, 5 U.S.c. §
552a, is overruled. See 5 U.S.C. § 552a(b)(lI).
2.

The Government will not include the Comments in the administrative

record for the Petition Response that it tiles with the Court on March 21, 2012.
3.

The Government will serve Plaintiffs with a copy of the Comments on

March 21, 2012.
4.

If Plaintiffs wish to rely on any of the Comments in support of their

motion for summary judgment regarding their claim brought in the Supplemental Complaint or
in opposition to the Government's motion for summary judgment on that same claim, they will
notify the Government, at least 3 business days in advance of a court filing, of their intent to rely
on such Comments. Prior to Plaintiffs' filing, the Government will redact from those Comments
on which Plaintiffs intend to rely any non-releasable private information.
5.

If the Government does not timely redact private information from the

Comments on which Plaintiffs wish to rely, or if there is any dispute over the extent of a
proposed redaction, Plaintiffs may tile the unredacted Comments under seaL

6.

Plaintiffs will use the Comments only in connection with this litigation.

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7.

In the event that Plaintiffs do rely on any of the Comments in support of

their motion for summary judgment regarding their claim brought in the Supplemental
Complaint or in opposition to the Government's motion for summary judgment on that same
claim, the Government reserves the right to respond by filing with the Court and relying on other
portions of the Comments in connection with its reply brief in support of its motion for summary
judgment.
8.

Any part of the Comments not filed with the Court in connection with the

parties' motions for summary judgment regarding the claims brought in the Supplemental
Complaint will not be considered part of the record before the Court.
9.
Dated:

The parties to this action consent to entry of this Order.

New York, New York
March 20, 2012

PREET BHARARA
United States Attorney
Southern District of New York
By:
MITCHELL S. BERNARD, Esq.
A VINASH KAR, Esq.
JENNIFER SORENSON, Esq.
Natural Resources Defense Council, Inc.
40 West 20th St.
New York, NY 10011
Tel.: [phone]
Fax: [phone]

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Attorney for pla:;/

so ORDERED:

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By:

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THE HONORABLE THEODORE H. KATZ
UNITED STATES MAGISTRATE JUDGE

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AMYi A.jBARCELO
Assist<ml United States Attorney
86 Chambers Street
New York, NY 10007
Tel.: [phone]
Fax: [phone]
AtturneyJor the Government