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

Filing 52

RESPONSE re: 42 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.,

)
)
)
)
)
)
)
Plaintiffs,
)
)
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.
)

11 CIV 3562 (THK)
ECF Case

PLAINTIFFS’ RESPONSE TO THE GOVERNMENT’S STATEMENT OF
UNDISPUTED MATERIAL FACTS PURSUANT TO LOCAL CIVIL RULE 56.1
Plaintiffs Natural Resources Defense Council, Center for Science in the Public Interest,
Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists respond to the
Statement of Undisputed Material Facts Pursuant to Local Civil Rule 56.1 submitted on January
9, 2012, by Defendants United States Food and Drug Administration (FDA); Margaret Hamburg,
in her official capacity as Commissioner, FDA; Center for Veterinary Medicine (CVM);
Bernadette Dunham, in her official capacity as Director, CVM; United States Department of

Health and Human Services (HHS); and Kathleen Sebelius, in her official capacity as Secretary,
HHS. Plaintiffs respond as follows:
1.
In 1977, FDA’s Bureau of Veterinary Medicine issued two notices of opportunity
for hearing that generally proposed to withdraw approval of penicillin and tetracycline in animal
feed because of safety concerns related to those uses (collectively, the “1977 NOOHs”). See
Penicillin-Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 43772 (Aug. 30, 1977)
(the “Penicillin NOOH”), attached as Exhibit D to Barcelo Decl.; Tetracycline (Chlortetracycline
and Oxytetracycline)-Containing Premixes; Opportunity for Hearing, 42 Fed. Reg. 56264 (Oct.
21, 1977) (the “Tetracycline NOOH”), attached as Exhibit E to the Barcelo Decl.
NOT CONTROVERTED.
2.
The Tetracycline NOOH included a series of important exceptions, through which
the use of tetracycline feeds would remain approved for certain “subtherapeutic conditions of
use.” Tetracycline NOOH, 42 Fed. Reg. at 56287.
CONTROVERTED IN PART AND NOT CONTROVERTED IN PART. Plaintiffs do
not controvert that FDA carved out seven limited exceptions from its proposal to withdraw “all
approvals for tetracycline-containing premix products intended for subtherapeutic uses in animal
feed . . . on the grounds that they have not been shown to be safe.” Tetracycline NOOH, 42 Fed.
Reg. at 56,287-88. Plaintiffs do controvert, as unsupported, Defendants’ contention that these
exceptions are “important.”
3.
In response to the 1977 NOOHs, approximately 20 drug firms, agricultural
organizations and individuals requested hearings on BVM’s proposals as set forth in the 1977
NOOHs. See Penicillin and Tetracycline in Animal Feeds Hearing, 43 Fed. Reg. 53827, 53828
(Nov. 17, 1978), attached as Exhibit G to the Barcelo Decl.
NOT CONTROVERTED.
4.
On November 9, 1978, the Commissioner granted these requests, announcing that
“there w[ould] be a formal evidentiary public hearing on these proposals,” and that a date for the
hearing would be set “as soon as practicable.” See Penicillin and Tetracycline in Animal Feeds
Hearing, 43 Fed. Reg. at 53828.
NOT CONTROVERTED.

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5.
In the late 1970s and early 1980s, Congress requested that FDA conduct further
studies and hold in abeyance the implementation of the 1977 NOOHs pending the outcome of
these studies. See H.R. Rep. No. 95-1290, at 99-100 (1978) (report by the House Committee on
Appropriations “recommend[ing]” that FDA conduct research regarding “whether or not the
continued subtherapeutic use of [the NOOH Products] would result in any significant human
health risk” before revoking such approval); H.R. Rep. No. 96-1095, at 105-06 (1980) (report by
the House Committee on Appropriations requesting FDA to “hold in abeyance any
implementation” of the proposed revocation pending further research); S. Rep. No. 97-248, at 79
(1981) (report by the Senate Committee on Appropriations making the same request); see also
FDA Draft Guidance for Industry #209, The Judicious Use of Medically Important Antimicrobial
Drugs in Food-Producing Animals (2010) at 6, attached as Exhibit B to the Barcelo Decl.
CONTROVERTED IN PART AND NOT CONTROVERTED IN PART. Plaintiffs do
not controvert that H.R. Rep. No. 95-1290 (1978), a report by the House Committee on
Appropriations; H.R. Rep. No. 96-1095 (1980), a report by the House Committee on
Appropriations; and S. Rep. No. 97-248 (1981), a report by the Senate Committee on
Appropriations, contain the statements attributed to them in paragraph 5 of Defendants’ 56.1
Statement. Plaintiffs do controvert that these nonbinding reports by congressional committees
amount to requests by “Congress.” See Tenn. Valley Auth. v. Hill, 437 U.S. 153, 191 (1978)
(“Expressions of committees dealing with requests for appropriations cannot be equated with
statutes enacted by Congress . . . .”); id. at 189-92; Nw. Envtl. Def. Ctr. v. Bonneville Power
Admin., 477 F.3d 668, 682 (9th Cir. 2007) (explaining that language in an appropriations
committee report that is “unconnected to the text of an enacted statute has no binding legal
import”). Plaintiffs further controvert this statement as not a statement of fact material to
Plaintiffs’ claims or Defendants’ defenses.
6.
No hearing has been held in connection with the 1977 NOOHs. See Withdrawal
of Notices of Opportunity for a Hearing; Penicillin and Tetracycline used in Animal Feed, 76
Fed. Reg. 79697, 79698 (Dec. 22, 2011), attached as Exhibit L to Barcelo Decl.
NOT CONTROVERTED.

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7.

On December 16, 2011, FDA withdrew the 1977 NOOHs. See 76 Fed. Reg.

79697.
CONTROVERTED IN PART AND NOT CONTROVERTED IN PART. Plaintiffs do
not controvert that FDA withdrew the 1977 NOOHs in a notice published in the Federal Register
on December 22, 2011. Plaintiffs controvert this statement as not a statement of fact material to
Plaintiffs’ claims or Defendants’ defenses.

Dated: January 31, 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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