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

Filing 58

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.. (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.,

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

11 CIV 3562 (THK)
ECF Case

PLAINTIFFS’ STATEMENT OF UNDISPUTED MATERIAL FACTS IN SUPPORT OF
MOTION FOR SUMMARY JUDGMENT ON THEIR THIRD CLAIM FOR RELIEF
Plaintiffs Natural Resources Defense Council, Center for Science in the Public Interest
(CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned
Scientists (UCS) respectfully submit this Statement of Undisputed Material Facts in support of
their Motion for Summary Judgment on their Third Claim for Relief.
Pursuant to Federal Rule of Civil Procedure 56 and this Court’s Local Civil Rule 56.1,
there is no genuine issue as to the following facts:

1.

Plaintiffs incorporate by reference paragraphs 1-4, 6-19, 23-24, 26-29, 32-43, and

68 of their Statement of Undisputed Material Facts in Support of Motion for Summary
Judgment, Oct. 6, 2011 (Dkt. 21).
2.

On March 9, 1999, CSPI, FACT, Public Citizen, and UCS submitted a petition to

FDA requesting that the agency “rescind approvals for subtherapeutic uses in livestock of any
antibiotic used in (or related to those used in) human medicine.” Citizen Petition 1-2 (Mar. 9,
1999), Ex. I to Decl. of Jennifer A. Sorenson, Oct. 5, 2011 (Sorenson Decl.) (Dkt. 33-9).
3.

On April 7, 2005, FACT and UCS submitted a second petition to FDA. The

petition requested that the FDA Commissioner “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 nonroutine use where a bacterial infection has been diagnosed within a herd or flock).” Citizen
Petition 1 (Apr. 7, 2005), Sorenson Decl. Ex. K (Dkt. 33-11). The petition covered penicillins,
tetracyclines, aminoglycosides, streptogramins, macrolides, lincomycin, and sulfonamides. Id.
4.

FDA delayed ruling on the petitions for twelve and six years respectively.

5.

In 2010, FDA issued Draft Guidance No. 209, which concludes that “using

medically important antimicrobial drugs for production purposes [i.e., increasing rate of weight
gain or improving feed efficiency] is not in the interest of protecting and promoting the public
health.” FDA, Draft Guidance No. 209, at 13 (June 28, 2010), Sorenson Decl. Ex. O (Dkt. 3315).
6.

Draft Guidance No. 209 recommends that medically important antibiotics be used

in food-producing animals (1) only when necessary to ensure the animals’ health, and not to
promote growth or improve feed efficiency, and (2) only with veterinary oversight. Id. at 16-17.

2

7.

On November 7, 2011, FDA denied both citizen petitions.

8.

In its final responses to both petitions, FDA stated that “we share your concern

about the use of medically important antimicrobial drugs in food-producing animals for growth
promotion and feed efficiency indications (i.e., production uses).” Final Response to Citizen
Petition, New Dkt. No. FDA-1999-P-1286 (Denial of 1999 Petition), at 1 (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), at 1 (Nov. 7, 2011),
Bernard Decl. Ex. B.
9.

The petition denials do not address the science underlying the petitions.

10.

In denying the petitions, FDA stated 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.
11.

The alternative strategy identified by FDA in the petition denials is the “strategy

set out in draft guidance #209.” Denial of 1999 Petition 4; Denial of 2005 Petition 4.
12.

Draft Guidance No. 209 has not yet been finalized.

13.

When final, Draft Guidance No. 209 will “not establish legally enforceable

responsibilities.” Draft Guidance No. 209, at 2.
//
//
//
//

3

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]
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]

4