Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
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MOTION to Strike Document No. [78-6]. 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 TO STRIKE NON-RECORD MATERIAL
Plaintiffs respectfully move to strike an industry statement relied on by FDA in its reply
brief in support of its motion for summary judgment. See Reply Mem. in Supp. of the
Government’s Mot. for Summ. J. on Pls.’ First Supplemental Compl. 13, Apr. 16, 2012 (Dkt.
77). The statement was issued last week by the Animal Health Institute (AHI), a trade
association representing manufacturers of animal drugs. See Ex. F to Third Decl. of Amy A.
Barcelo (3d Barcelo Decl.), Apr. 16, 2012 (Dkt. 78-6). It is not part of the administrative record
that was before FDA when the agency denied plaintiffs’ citizen petitions in November 2011.
Because this Court’s review is limited to the record before FDA at the time it denied the
petitions, the Court should strike the AHI statement.
ARGUMENT
“It is a widely accepted principle of administrative law that the courts base their review
of an agency’s actions on the materials that were before the agency at the time its decision was
made.” IMS, P.C. v. Alvarez, 129 F.3d 618, 623 (D.C. Cir. 1997); see Walter O. Boswell Mem’l
Hosp. v. Heckler, 749 F.2d 788, 792 (D.C. Cir. 1984) (“If a court is to review an agency’s action
fairly, it should have before it neither more nor less information than did the agency when it
made its decision.” (emphasis added)). Courts do not consider material that postdates the
agency’s decision because to do so “risks . . . requiring administrators to be prescient or allowing
them to take advantage of post hoc rationalizations.” Walter O. Boswell Mem’l Hosp., 749 F.2d
at 792; see id. at 793-94 (noting that the court had struck the portion of an amicus brief
discussing a study performed after the agency had made its decision).
As a basis for denying plaintiffs’ citizen petitions, FDA asserted its faith in the voluntary
cooperation of industry in implementing the agency’s Draft Guidance No. 209, which
discourages “injudicious” uses of medically important antibiotics in livestock. See FDA, Draft
Guidance No. 209, at 16-17 (2010) (Administrative Record, at FDA 182-83); Ex. A to Decl. of
Mitchell S. Bernard (Bernard Decl.) 4, Feb. 21, 2012 (Dkt. 59-1); Bernard Decl. Ex. B, at 3-4
(Dkt. 59-2). Having failed to identify any evidence in the record that supports its professed
confidence in voluntary measures, FDA cannot now rely on AHI’s April 11, 2012 statement,
issued more than five months after the agency denied the petitions. Although the statement
provides little support for FDA’s position—it expresses only vague agreement with FDA’s
“direction” on antibiotics in livestock, while maintaining that “there are details that must be
addressed to make this approach practical and workable,” see 3d Barcelo Decl. Ex. F, at 1—
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plaintiffs object to FDA’s reliance on material that is not part of the administrative record. This
Court should strike the AHI statement in its entirety.
The same reasoning applies to the three documents that FDA published last week and has
submitted twice to this Court—once by letter, dated April 11, 2012, and a second time with its
reply brief, filed on April 16, 2012. See 3d Barcelo Decl. Exs. A, B & C (Dkts. 78-1 to 78-3).
These documents—Guidance No. 209, Draft Guidance No. 213, and draft proposed revisions to
FDA’s Veterinary Feed Directive regulation—are not part of the administrative record on which
FDA denied the citizen petitions. To the extent that FDA now relies on them to justify its denials
of the petitions, the Court should disregard them.
CONCLUSION
To ensure that it is reviewing FDA’s denials of the citizen petitions based on the same
information that was before the agency when it issued the denials, this Court should strike the
April 11, 2012 statement by AHI (Dkt. 78-6).
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Dated: April 18, 2012
Respectfully submitted,
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
(212) 727-2700
(212) 727-1773 (fax)
mbernard@nrdc.org
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
(415) 875-6100
(415) 875-6161 (fax)
akar@nrdc.org; jsorenson@nrdc.org
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
(214) 827-2774
(214) 827-2787 (fax)
sgardner@cspinet.org
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