Ctr. for Food Safety v. Hamburg, Consolidated Case No. 14-cv-04932-YGR

CourtUnited States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
Docket NumberConsolidated Case No. 14-cv-04932-YGR,Consolidated Case No. 14-cv-04933-YGR
PartiesCENTER FOR FOOD SAFETY, et al., Plaintiffs, and HUMANE SOCIETY OF THE UNITED STATES, et al., Plaintiffs, v. MARGARET A. HAMBURG, Commissioner, United States Food and Drug Administration, et al., Defendants, and ELANCO ANIMAL HEALTH, Intervenor-Defendant.
Decision Date05 November 2015

CENTER FOR FOOD SAFETY, et al., Plaintiffs,
MARGARET A. HAMBURG, Commissioner,
United States Food and Drug Administration, et al., Defendants,
and ELANCO ANIMAL HEALTH, Intervenor-Defendant.

Consolidated Case No. 14-cv-04932-YGR
Consolidated Case No. 14-cv-04933-YGR


November 5, 2015


Re: Dkt. No. 58

Plaintiffs Center for Food Safety, et al., (collectively, "plaintiffs") bring these cases against defendants United States Food and Drug Administration ("FDA") and Margaret Hamburg, in her official capacity as the Commissioner of the FDA (collectively, "defendants"), alleging violations of the National Environmental Protection Act ("NEPA") and the Administrative Procedure Act ("APA"). Plaintiffs seek declaratory and injunctive relief directing the FDA to comply with NEPA and its implementing regulations with respect to approval of ractopamine hydrochloride ("ractopamine") and ractopamine combination animal drugs from 2008 to 2014. On March 5,

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2015, the Court consolidated the two cases for all purposes. (Dkt. No. 32.)1 Intervenor-defendant Elanco Animal Health ("Elanco") moved to intervene in both cases, and on April 1, 2015, the Court granted Elanco's motion. (Dkt. No. 45.)

Pending before the Court is defendant-intervenor Elanco's2 motion to dismiss the complaints for plaintiffs' failure to exhaust administrative remedies. (Dkt. No. 58, "Mtn.") Having carefully considered the papers submitted3 and the pleadings in this action, oral argument on September 8, 2015, and for the reasons set forth below, the Court hereby Grants Elanco's motion to dismiss the complaints.


The FDA first approved the use of ractopamine in 1999 for pigs and later approved it for cattle and turkeys. (Dkt. No. 1, "CFS Compl.," ¶ 36; Dkt. No. 1, 14-cv-4933, "HSUS Compl.," ¶ 34.) Ractopamine has a number of metabolic effects on animals, including a shift in dietary energy balance "toward skeletal muscle growth as opposed to fat deposition." (CFS Compl. ¶ 31; HSUS Compl. ¶ 27.) Elanco manufactures ractopamine, and markets the drug as a "feed additive to induce faster growth and leaner meat in pigs, cattle, and turkeys." (CFS Compl. ¶ 35; HSUS Compl. ¶ 27.) Ractopamine is also used in combination with other pharmaceuticals, including tylosin, monensin, and melengestrol. (CFS Compl. ¶¶ 68-99; HSUS Compl. ¶¶ 73-103.)

Plaintiffs are public interest organizations whose missions include protecting human health and the environment by, for example, "challenging harmful food production technologies and promoting sustainable alternatives." (CFS Compl. at ¶ 11.) Additionally, the missions of certain

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plaintiffs focus on animal protection and animal health risks (HSUS Compl. at ¶¶ 8, 17), as well as the interests of farmworkers in the United States (Id. at ¶ 11). Plaintiffs bring this consolidated action to challenge the FDA's approval of animal drug applications for animal drugs containing ractopamine. (CFS Compl. ¶ 1; HSUS Compl. ¶ 1.) Specifically, plaintiffs allege that that FDA did not comply with the requirements of NEPA4 with respect to its consideration of impact on the environment when it approved the ractopamine-containing animal drug applications beginning in 2008 (the "FDA approvals"). (CFS Compl. ¶ 120; HSUS Compl. ¶ 119). Plaintiffs allege that, as a result of FDA's inadequate NEPA review, the FDA approvals were "arbitrary and capricious, an abuse of discretion, and otherwise not in accordance with NEPA...and must be set aside." (CFS Compl. ¶ 138, 149; HSUS Compl. ¶ 131, 135.) Plaintiffs therefore request, primarily, that the Court: (i) declare that the FDA approvals violated NEPA and its implementing regulations; and (ii) vacate and remand the FDA approvals to FDA. (See CFS Compl.; HSUS Compl.) Moreover, the CFS complaint requests that the Court issue a preliminary and permanent injunction "barring the use of ractopamine-based animal drugs until FDA complies with NEPA." (CFS Compl., Prayer for Relief, ¶ 3.)

Due to statutory and regulatory requirements that applications to FDA for new drugs remain confidential, see 21 U.S.C. § 331(j); 21 CFR §§ 514.11, 514.12, plaintiffs only became aware of the approvals, and FDA's associated decision-making, when they were final and published in the Federal Register. (CFS Compl. ¶ 118, 121; HSUS Compl. ¶ 117, 122.) Thus, plaintiffs were not able to participate in the administrative process prior to the FDA approvals at issue. (Id.) Central to defendant-intervenor's motion to dismiss, plaintiffs do not allege that they pursued any administrative remedies with the FDA relating to their NEPA grievances following the FDA approvals. As discussed more fully below, plaintiffs actually concede the same but contend that either they were not required to do so, or in the alternative, that the Court should

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waive the exhaustion requirement under these circumstances.


A. Statutory Framework

Congress enacted NEPA in 1969 to protect the environment by requiring federal agencies to follow certain procedural steps before taking any action affecting the environment. On its own, NEPA "does not provide a private cause of action for violation of its provisions." Salmon River Concerned Citizens v. Robertson, 32 F.3d 1346, 1353 n. 13 (9th Cir. 1994). Thus, plaintiffs correctly proceed under the APA, which does provide a cause of action to parties seeking judicial review of agency NEPA decisions, subject to several limitations. See id.; 5 U.S.C. § 702.

Relevant here is the APA's requirement "that plaintiffs exhaust available administrative remedies before bringing their grievances in federal court." Idaho Sporting Congress, Inc. v. Rittenhouse, 305 F.3d 957, 965 (9th Cir. 2002) (citing 5 U.S.C. § 704). "The purpose of the exhaustion doctrine is to allow the administrative agency in question to exercise its expertise over the subject matter and to permit the agency an opportunity to correct any mistakes that may have occurred during the proceeding, thus avoiding unnecessary or premature judicial intervention into the administrative process." Buckingham v. Secretary of U.S. Dept. of Agr., 603 F.3d 1073, 1080 (9th Cir. 2010) (quoting United Farm Workers v. Ariz. Agric. Employment Relations Bd., 669 F.2d 1249, 1253 (9th Cir. 1982)). The APA requirement that plaintiffs exhaust administrative remedies "applies to claims under NEPA." Great Basin Mine Watch v. Hankins, 456 F.3d 955, 965 (9th Cir. 2006); See Save Strawberry Canyon v. U.S. Dept. of Energy, 830 F.Supp.2d 737, 745 (N.D.Cal. 2011) ("[a] NEPA plaintiff must exhaust administrative remedies before seeking judicial review of the administrative process").

The APA does not mandate a particular process by which a plaintiff must exhaust administrative remedies before seeking judicial review in federal court. Rather, the exhaustion doctrine exists under the APA only "to the extent that it is required by statute or agency rule as a prerequisite to judicial review." Darby v. Cisnero, 509 U.S. 137, 153 (1993). Although the FDA approval process is relatively closed to the public, the FDA has created a regulatory mechanism by which interested persons may challenge the Commissioner's activities under the Food, Drug, and

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Cosmetic Act ("FDCA"). See 21 CFR §§ 10.1(a), 10.25(a), 10.45(b). Namely, 21 CFR section 10.25(a) provides, in pertinent part: "[a]n interested person may petition the Commissioner to issue, amend or revoke a regulation or order, or to take or refrain from taking any other form of administrative action....in the form of a citizen petition." See Aventis Pharma S.A. v. Amphastar Pharms., Inc., 2009 WL 8727693, at *2 (C.D.Cal. Feb. 17, 2009) ("Any person may try to affect FDA action.The FDA encourages this, maintaining an open invitation to the public to file a 'citizen petition.'"). Not only do the FDA regulations allow an interested person to file a citizen petition, but they also mandate that any "request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative decision based on a petition submitted under § 10.25(a)...before any legal action is filed in a court complaining of the action or failure to act." 21 CFR 10.45(b).

The FDA regulations, therefore, "require that a request" be made to the Commissioner before filing a complaint in court complaining of an administrative action or failure to act. Ass'n of Am. Physicians & Surgeons, Inc. v. FDA, 539 F.Supp.2d 4, 21 (D.D.C. 2008) (emphasis in original). Failure to comply with this exhaustion requirement warrants dismissal of a grievance filed in federal court in the first instance. See id., affirmed by 358 F.App'x 179, 180-81 (D.C. Cir. 2009) (appellants failed to exhaust their administrative remedies where they "filed no such citizen petition with the FDA"); Dietary Supplement Coalition, Inc. v. Sullivan, 796 F.Supp. 441, 446 (D.Or. 1991) (dismissing complaint, in part, because plaintiff failed to exhaust administrative remedies by filing a citizen petition with the FDA); IMS Ltd. v. Califano, 453 F.Supp. 157, 160 (C.D.Cal. 1977) (noting that plaintiffs could have, but chose not to, file a citizen petition as an avenue to exhaust administrative remedies with the FDA). The citizen petition requirement applies to all "administrative proceedings and activities conducted by the [FDA] under the [FDCA] ... and other laws that the Commissioner of Food and Drugs administers." 21 CFR § 10.1 (emphasis supplied).

B. Analysis

Plaintiffs do not contest that the above-cited FDA regulations generally require an interested person to file a citizen petition before filing a complaint in federal court compelling the

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FDA Commissioner to take administrative action. Instead, plaintiffs...

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