Organic Pastures Dairy Company, LLC v. Sebelius et al

Filing 62

ORDER DENYING Plaintiff's Motion to Supplement the Administrative Record (Doc. 57 ), Signed by Magistrate Judge Stanley A. Boone on 8/29/2013. (Arellano, S.)

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UNITED STATES DISTRICT COURT

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EASTERN DISTRICT OF CALIFORNIA
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ORGANIC PASTURES DAIRY COMPANY, Case No. 1:12-cv-02019-SAB
LLC,
ORDER DENYING PLAINTIFF’S MOTION
Plaintiff,
TO SUPPLEMENT THE
ADMINISTRATIVE RECORD
v.
ECF NO. 57
KATHLEEN SEBELIUS, et al.,
Defendants.

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On August 9, 2013, Plaintiff Organic Pastures Dairy Company, LLC (“Organic

19 Pastures”) filed a motion to supplement the administrative record in this action. (ECF No. 57.)
20 A hearing on this matter took place on August 28, 2013.
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For the reasons set forth below, the Court finds that Organic Pastures has failed to

22 demonstrate grounds to supplement the administrative record.
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I.

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BACKGROUND

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In this lawsuit, Organic Pastures seeks judicial review of Defendant United States Food

26 and Drug Administration’s (“FDA”) denial of Organic Pastures’ citizen petition.

Organic

27 Pastures filed a citizen petition with the FDA on December 22, 2008. The citizen petition sought
28 modification of 21 C.F.R. § 1240.61, which prohibits the sale of unpasteurized milk (also known

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1 as “raw milk”) across state lines. Organic Pastures requested an exemption that permitted the
2 sale of raw milk across state lines so long as the sale was legal in both the seller’s state and the
3 destination state.
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Organic Pastures initially filed this action in federal court on December 12, 2012 seeking

5 a writ of mandamus to compel the FDA to respond to the citizen petition. (ECF No. 1.) On
6 February 26, 2013, after this action was filed, the FDA denied the citizen petition. Organic
7 Pastures then filed an amended complaint seeking judicial review of the FDA’s denial of the
8 citizen petition. Organic Pastures contends that the FDA’s denial was arbitrary and capricious.
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In May 2013, Organic Pastures submitted a subsequent petition to the FDA to modify the

10 FDA’s response, which included additional documents that Organic Pastures contends the FDA
11 should have considered in connection with the original citizen petition.
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The administrative record was filed in this action on July 3, 2013. (ECF No. 53.) The

13 administrative record consists of the FDA’s records related to their February 26, 2013 final
14 response to Organic Pastures’ citizen petition. However, the administrative record does not
15 include the additional documents submitted by Organic Pastures in its May 2013 petition to
16 modify.
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Organic Pastures now seeks to supplement the administrative record in this action to

18 include the additional documents submitted by Organic Pastures in its May 2013 petition to
19 modify. At the hearing on this matter, Organic Pastures conceded that it had not previously
20 attempted to submit the additional documents now at issue to the FDA when the FDA was
21 responding to the citizen petition.
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II.

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LEGAL STANDARDS

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In this action, Organic Pastures seeks judicial review of agency action under the

25 Administrative Procedures Act. See 7 U.S.C. § 702 (“A person suffering legal wrong because of
26 agency action, or adversely affected or aggrieved by agency action within the meaning of a
27 relevant statute, is entitled to judicial review thereof.”).
28 / / /

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When a plaintiff challenges a final agency action, judicial review normally is limited to

2 the administrative record in existence at the time of the agency’s decision. Friends of the
3 Clearwater v. Dombeck, 222 F.3d 552, 560 (9th Cir. 2000). “In these cases, the agency must
4 justify its final action by reference to the reasons it considered at the time it acted.”

Id.

5 However:
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In limited circumstances, district courts are permitted to admit
extra-record evidence: (1) if admission is necessary to determine
“whether the agency has considered all relevant factors and has
explained its decision,” (2) if “the agency has relied on documents
not in the record,” (3) “when supplementing the record is
necessary to explain technical terms or complex subject matter,” or
(4) “when plaintiffs make a showing of agency bad faith.”

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10 Lands Council v. Powell, 395 F.3d 1019, 1030 (9th Cir. 2004) (quoting Southwest Center for
11 Biological Diversity v. U.S. Forest Service, 100 F.3d 1443, 1450 (9th Cir. 1996)). At the hearing
12 on this matter, Organic Pastures stated that they sought to supplement the administrative record
13 in this case under the first (whether the agency considered all relevant factors) and fourth (bad
14 faith) exceptions.
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“Though widely accepted, these exceptions are narrowly construed and applied.” Id.; see

16 also Cactus Corner, LLC v. U.S. Dept. of Agriculture, 346 F. Supp. 2d 1075, 1105 (E.D. Cal.
17 2004) (“Supplementation of an administrative record is the exception, not the rule.”). “Were the
18 federal courts routinely or liberally to admit new evidence when reviewing agency decisions, it
19 would be obvious that the federal courts would be proceeding, in effect, de novo rather than with
20 the proper deference to agency processes, expertise, and decision-making.” Id.
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A district court’s decision whether to admit extra-record evidence is reviewed for abuse

22 of discretion. Southwest Center for Biological Diversity, 100 F.3d at 1447.
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III.

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DISCUSSION

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A.

The FDA’s Four Year Delay In Issuing A Response to Organic Pastures’
Citizen Petition Does Not Exhibit Bad Faith

Organic Pastures argues that the Court should look at evidence beyond the administrative

28 record because the FDA acted in bad faith in denying Organic Pastures’ citizen petition. (Pl.’s

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1 Mem. in Supp. of Mot. to Suppl. the Admin. Rec. (“Pl.’s Mem.”) 4:15-5:22.) For the bad faith
2 exception to apply, there must be a strong showing of bad faith or improper behavior. Animal
3 Defense Council v. Hodel, 840 F.2d 1432, 1437 (9th Cir. 1988).
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Organic Pastures contends that the FDA exhibited bad faith by delaying their response to

5 Organic Pastures’ citizen petition for four years. Organic Pastures contends that the FDA “failed
6 to provide for any meaningful process in reaching its denial, such as engaging in discussions
7 with Organic Pastures or holding public hearings” during this four year period. (Pl.’s Mem. 5:28 4.) Organic Pastures also contends that the FDA “failed to update its record of documents and
9 information before deciding against the petition.”

(Pl.’s Mem. 5:5-6.)

Organic Pastures

10 contends that new and relevant information has become available in the four year period that the
11 FDA did not consider in reaching its decision. (Pl.’s Mem. 5:7-22.)
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Organic Pastures cites Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y. 2009) in

13 support of its argument that the administrative record should be supplemented due to the FDA’s
14 bad faith. In Tummino, the plaintiffs submitted a citizen petition to the FDA regarding the Plan
15 B contraceptive. Id. at 522-23. The court permitted the introduction of extra record evidence
16 based upon the bad faith exception. Id. 543-44. The court’s bad faith finding was based upon 1)
17 “the unusual involvement of FDA upper management in the review process,” 2) “evidence that
18 FDA officials were motivated by ‘improper concerns about the morality of adolescent sexual
19 activity,’” 3) “evidence that the decision not to approve the OTC switch was made before review
20 staff had completed their reviews,” 4) “the refusal to adopt the recommendations of professional
21 review staff and the Advisory Committee,” 5) the resignations of officials within the agency in
22 connection with the matter addressed in the citizen petition, and 6) “the GAO’s findings of
23 procedural irregularities...” Id. at 544.
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The facts here are distinguishable to those in Tummino. In this case, Organic Pastures’

25 bad faith argument is premised entirely on the FDA’s delayed response to Organic Pastures’
26 citizen petition. Here, there is no suggestion that the FDA was motivated by improper political
27 concerns and there is no evidence of procedural irregularities. Moreover, the extra-record
28 evidence that Organic Pastures seeks to introduce has no relationship to the alleged bad faith

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1 delay. In Tummino, introduction of extra-record evidence was necessary to determine whether
2 the FDA acted in bad faith. See also Nehemiah Corp. of America v. Jackson, 546 F. Supp. 2d
3 830, 848 (E.D. Cal. 2008) (permitting introducing of extra-record evidence that agency
4 improperly prejudged the merits of a proposed rule).
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The extra-record evidence in this case does not evidence bad faith. In fact, the extra-

6 record evidence in this case is inconsistent with Organic Pastures’ bad faith argument. Organic
7 Pastures contends that much of the extra-record evidence consists of new information that
8 became available after Organic Pastures submitted its citizen petition in 2008. Had the FDA
9 responded to Organic Pastures’ citizen petition in a more timely manner, it could have avoided
10 consideration of this extra-record evidence by issuing a decision before the extra-record evidence
11 came into existence. In other words, if the new information was favorable to Organic Pastures’
12 position, it is unclear how the FDA acted in bad faith by delaying and allowing this information
13 to become available before issuing its decision. Organic Pastures does not identify any other bad
14 faith motive behind the FDA’s delay. Accordingly, the FDA’s four year delay in responding to
15 Organic Pastures’ citizen petition does not demonstrate bad faith warranting consideration of
16 extra-record evidence.
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Based upon the foregoing, the Court finds that the FDA did not delay its response to the

18 citizen petition in bad faith, warranting expansion of the administrative record.

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There Insufficient Evidence Supporting Organic Pastures’ Claim That The
FDA Negligently Or Intentionally Excluded Material Documents From The
Record

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Organic Pastures argues that the Court should consider extra-record evidence because the

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B.

22 FDA negligently or intentionally excluded material documents from the record. (Pl.’s Mem.
23 5:23-9:23.) Courts have treated an administrative agency’s exclusion of documents from the
24 administrative record as falling under the bad faith exception discussed above.

See, e.g.,

25 McCrary v. Gutierrez, 495 F. Supp. 2d 1038, 1043 (N.D. Cal. 2007). Thus, as discussed above,
26 Organic Pastures must make “a strong showing of bad faith or improper behavior” with respect
27 to the exclusion of documents in order to invoke the exception. Animal Defense Council, 840
28 F.2d at 1437; McCrary, 495 F. Supp. 2d at 1043.

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Organic Pastures contends that the FDA excluded documents from the administrative

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2 record in bad faith because some of the excluded documents were in the possession of the FDA
3 or in the possession of other agencies within the Department of Health and Human Services
4 (“HHS”).1 However, the cases cited by Organic Pastures are distinguishable from the facts in
5 this case. In Kent County, Delaware Levy Court v. U.S. E.P.A., 963 F.2d 391, 396 (D.C. Cir.
6 1992), the court found that the EPA negligently failed to examine “the Region III CERCLA
7 files” for relevant information. The court acknowledged it was not “the EPA’s responsibility to
8 find all documents ... located in any office of the EPA.” Id. (italics in original). However, the
9 court found it inexcusable that the regional EPA office that issued the decision failed to examine
10 its own files for relevant documents.
In this case, several documents identified by Organic Pastures are documents that were

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12 authored outside the FDA. Although some of these agencies are other Operating Divisions under
13 the umbrella of HHS, Organic Pastures does not demonstrate how it constitutes bad faith for the
14 FDA to exclude these documents from the administrative record.2
With respect to the FDA authored documents, Organic Pastures fails to demonstrate that

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16 the extra-record evidence was located somewhere that the FDA should have looked before
17 issuing its response to Organic Pastures’ citizen petition. Several of these documents are only
18 remotely relevant to the raw milk citizen petition. Organic Pastures claims that FDA documents
19 such as “FDA Food Facts: Food Allergies,” “Letter to Cantaloupe Industry on Produce Safety,”
20 and “FDA Investigates a Multistate Outbreak of listeria,” should have been included in the
21 administrative record because the FDA allegedly was inconsistent in its regulation of different
22 food products. Irrespective of the merits of this line of argument, there is no suggestion that
23 there was any bad faith motive on the FDA’s part by their failure to consider these documents.
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The FDA is an Operating Division under the umbrella of HHS. HHS Leadership: Open Government at HHS,

25 http://www.hhs.gov/open/contacts/index.html#od (last visited Aug. 22, 2013). Organic Pastures contends that

relevant evidence was in the possession of other sub-agencies under HHS, such as the National Institute of Health

26 and the Center for Disease Control. Id.
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One document was authored by the Government Accountability Office (“GAO”), which is not an Operating
Division under HHS. Organic Pastures does not offer any theory as to why the FDA should have considered
documents authored by GAO when responding to the citizen petition.

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1 Had Organic Pastures expressly asked the FDA to compare raw milk to cantaloupes, Organic
2 Pastures’ argument may have some merit. However, short of that, the Court does not find any
3 suggestion of bad faith on the FDA’s part by their failure to isolate cantaloupes for comparison
4 to raw milk
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The FDA’s report on “Food Facts: The Dangers of Raw Milk” is the only document that

6 appears to be facially relevant to the issue raised in the citizen petition and authored by the FDA.
7 However, Organic Pastures does not present sufficient evidence that this omission was done in
8 bad faith. There is no evidence that this particular document was physically located somewhere
9 the FDA would have been expected to look when researching its response to the citizen petition.
10 There is also no convincing evidence that the FDA’s failure to include the document in the
11 administrative record was done for improper reasons.

At the hearing, Organic Pastures

12 contended that the Dangers of Raw Milk document was adverse to the FDA’s position because it
13 conceded that the health risks from consuming homemade ice cream may be caused by the use of
14 raw eggs, rather than from the raw milk. Given the relatively minor concession in a document
15 that, based on its title, appears to be generally supportive of the FDA’s position, the Court cannot
16 conclude that the Dangers of Raw Milk document was deliberately omitted by the FDA in bad
17 faith.
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Organic Pastures’ argument that the FDA negligently or deliberately excluded evidence

19 that was adverse to its position is undermined by the fact that Organic Pastures initiated the
20 administrative proceedings by challenging the FDA’s regulations through a citizen petition.
21 Organic Pastures does not dispute that it could have submitted additional evidence along with its
22 citizen petition. Organic Pastures argues that the omission of documents at the time the citizen
23 petition was filed is attributable to the fact that Organic Pastures was not represented by legal
24 counsel at the time. However, the pertinent regulations permit Organic Pastures to supplement
25 the administrative record at any time before the FDA’s decision. 21 C.F.R. 10.30(g). It is
26 undisputable that Organic Pastures was represented by legal counsel at the time the petition for a
27 writ of mandamus was filed in this action on December 12, 2012. Organic Pastures provides no
28 explanation why they made no attempt to supplement the administrative record at that time.

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Based upon the foregoing, the Court finds that the FDA did not negligently or

2 deliberately exclude documents from the administrative record. Therefore, expansion of the
3 administrative record is not warranted.

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There Is Insufficient Evidence Supporting Organic Pastures’ Claim That
Admission Of Extra-Record Evidence Is Necessary To Determine Whether
The FDA Considered All Relevant Factors

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Organic Pastures argues that admission of extra-record evidence is necessary to

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C.

7 determine whether the FDA has considered all relevant factors in reaching is decision on the
8 citizen petition. Lands Council, 395 F.3d at 1030 (quoting Southwest Center for Biological
9 Diversity, 100 F.3d at 1450). “[T]o satisfy the ‘relevant factors’ exception, a plaintiff must
10 establish more than just that the document is relevant. In fact, the document in question must do
11 more than raise ‘nuanced points’ about a particular issue; it must point out an ‘entirely new’
12 general subject matter that the defendant agency failed to consider.” Pinnacle Armor, Inc. v.
13 U.S., No. 1:07-cv-01655 LJO DLB, 2013 WL 509047, at *4 (E.D. Cal. Feb. 12, 2013) (citing In
14 re Delta Smelt Consolidated Cases, No. 1:09-cv-1053 OWW DLB, 2010 WL 2520946, at *5
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Here, Organic Pastures fails to convincingly demonstrate that the extra-record evidence at

17 issue concerns an entirely new general subject matter not previously considered by the FDA.
18 Organic Pastures contends that the relevant factor that the FDA failed to consider was “the
19 Defendants’ arbitrary treatment of unpasteurized dairy products intended for human consumption
20 relative to other foods, including but not limited to pasteurized dairy products.” (Pl.’s Reply to
21 Defs.’ Opp’n to Pl.’s Mot. to Suppl. the Admin. Rec. (“Pl.’s Reply”) 4:23-26.)
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The issue raised by Organic Pastures is merely a “nuanced point” about the broader issue

23 of whether raw milk is deemed safe for human consumption. Organic Pastures does not deny
24 that the FDA addressed the issue of safety in its response to the citizen petition. Organic
25 Pastures contends that the FDA’s treatment of raw milk relative to other foods presents an
26 entirely new general subject matter. However, Organic Pastures fails to cite any legal authority
27 that suggests that the FDA has an independent obligation to perform relative comparisons
28 between raw milk and other food products.

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Moreover, it is worth noting that Organic Pastures’ own citizen petition did not frame the

2 relative treatment of raw milk compared to other foods as an “entirely new general subject matter
3 that the agency failed to consider.” In the “Action requested” section of the citizen petition,
4 Organic Pastures sought an amendment of the regulation prohibiting the interstate sale of raw
5 milk. (Defs.’ Opp’n to Pl.’s Mot to Suppl. the Admin. Rec. (“Defs.’ Opp’n”) Ex. A, at pg. 1.)
6 The “Statement of grounds” section does conclude with the argument that:
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No other foods have been singled out for state line FDA
prohibition. Raw milk stands alone as the single food that can not
be taken across state lines and consumed. There is no rational
argument that can be made to defend this regulation.

10 (Defs.’ Opp’n Ex. A, at pg. 6.) However, the citizen petition makes no argument that the
11 differential treatment of raw milk is an entirely new subject matter and ground to amend the raw
12 milk regulations. The citizen petition does not expressly ask the FDA to compare its regulation
13 of raw milk to its regulation of other foods. Taken in context, the statement that raw milk had
14 been “singled out” was presented by Organic Pastures more as a sub-argument in support of the
15 general proposition that raw milk is safe enough to transport across state lines rather than an
16 “entirely new” subject matter justifying expansion of the administrative record.
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Organic Pastures argues that the FDA treats raw milk differently than it treats other foods

18 and that the FDA singled out raw milk as the only product subject to a prohibition on interstate
19 sale. However, this argument speaks to the merits of Organic Pastures’ petition for judicial
20 review rather than the present issue of whether the administrative record should be supplemented
21 with additional evidence.
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In a case analogous to this case, the district court for the District of Columbia held that

23 the “relevant factors” exception did not apply when plaintiffs sought to introduce evidence from
24 a separate case for the purpose of comparing the agency’s actions in the separate case to the case
25 at bar. Marcum v. Salazar, 751 F. Supp. 2d 74, 81 (D.D.C. 2010). In a case involving judicial
26 review of the United States Fish & Wildlife Service’s (“the Service”) denial of plaintiffs’
27 elephant trophy import application, the plaintiffs argued that the administrative record should be
28 supplemented with the record from a prior case involving elephant trophy imports. The court

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1 held that “[t]he Service was not obliged to consider the [prior case records] in the present case,
2 which involves different plaintiffs challenging different permit denials.” Id. at 82.
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In this case, the FDA considered the health hazards presented by raw milk in reaching its

4 decision on the citizen petition.

The additional evidence proposed by Organic Pastures

5 pertaining to the risks posed by other foods merely provides a “nuanced point” on the same
6 issue. Accordingly, such evidence does not qualify as an exception to the general rule that this
7 Court should not look beyond the administrative record in reviewing the FDA’s response to the
8 citizen petition.
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More importantly, as discussed above, Organic Pastures framed the issues associated

10 with this present case. They filed their first citizen petition in 2008 and never sought to amend
11 or supplement the petition. Instead they chose judicial intervention under the APA, which is
12 limited in scope and is not intended for Court’s to substitute their judgment for that of the
13 administrative agency. Organic Pastures then filed a petition to modify in May 2013 addressing
14 the issues now being raised more succinctly. The Court’s role is to review the FDA’s response
15 to the original citizen petition, not preempt the FDA’s response to the petition to modify. To
16 merely supplement the record by adding the documents at Organic Pastures request would be the
17 equivalent of usurping the FDA’s role in responding to the petition to modify filed by Organic
18 Pastures. This Court will review the FDA’s decision of February 2013 under the APA in the
19 manner framed by the Plaintiff.
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IV.

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CONCLUSION AND ORDER

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For the reasons set forth below, the Court finds that there exist no grounds to supplement

23 the administrative record with the evidence proposed by Organic Pastures.
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Accordingly, it is HEREBY ORDERED that Organic Pasture’s motion to supplement the

2 administrative record is DENIED.
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IT IS SO ORDERED.

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Dated:
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August 29, 2013

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UNITED STATES MAGISTRATE JUDGE

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