Summary of a Recent
Judicial Development in
Environmental Law

Failure to Exhaust Administrative Remedies Provided by
the Federal Food, Drug, and Cosmetic Act

Eric H. Foy
National AgLaw Center Research Associate

Summary of Decision

In Geertson Farms, Inc. v. Johanns, 439 F. Supp. 2d 1012 (N.D. Cal. 2006), the United States District Court for the Northern District of California granted the U.S. Environmental Protection Agency's (EPA) motion to dismiss the plaintiffs' lawsuit. The plaintiffs, organic farmers, filed suit against the EPA for deregulating genetically modified alfalfa hay containing glyphosate. The plaintiffs argued that the deregulation violated the Endangered Species Act (ESA) because the EPA had failed to consult with the Fish and Wildlife Service regarding the potential effect of the deregulation on endangered species. In granting the motion to dismiss, the instant court held that the plaintiffs' claim was within the purview of the Federal Food, Drug, and Cosmetic Act's (FFDCA) exclusive review provision, and the plaintiffs had failed to exhaust the FFDCA's administrative remedies.

Background

In 1999, Monsanto Company licensed Roundup Ready alfalfa containing glyphosate, "a common pesticide that blocks an enzyme essential for green plant growth." Id. at 1014. After licensing the product, Monsanto sought a tolerance level determination for glyphosate. Id. In response to Monsanto's request, the EPA established a tolerance for glyphosate residues in alfalfa hay on September 27, 2002, and for alfalfa seed on February 16, 2005. Id. Shortly after establishing the second tolerance level, the U.S. Department of Agriculture (USDA) published a Deregulation Determination concluding that the engineered alfalfa "would not present risk of plant pest introduction or dissemination" and "[would] not harm threatened or endangered species or organisms that [were] beneficial to agriculture; and . . . should not reduce the ability to control pests and weeds in alfalfa or other crops." Id. (quoting 70 Fed. Reg. 36917, 36918-19 (June 27, 2005)). The Deregulation Determination essentially freed genetically engineered alfalfa from regulation by the USDA's Animal and Plant Health Inspection Service (APHIS). Id. In response, the plaintiffs filed the instant suit. Id.

Arguments

The EPA moved to dismiss the plaintiffs' claim because the court lacked subject matter jurisdiction pursuant to Rule 12(b)(1) of the Federal Rules of Civil Procedure for two reasons: (1) the plaintiffs failed to exhaust their administrative remedies pursuant to the FFDCA, and (2) the plaintiffs lacked standing. Id. at 1013.

The plaintiffs did not dispute that they had not exhausted their administrative remedies under the FFDCA; instead, they argued that exhaustion was not necessary because the court had subject matter jurisdiction pursuant to the ESA. Id. at 1016.

Analysis and Holdings

According to the FFDCA's implementing regulations, judicial review is unavailable for "[a]gency actions subject to the objection procedure of the FFDCA section [346a(g)(2)] . . . unless an adversely affected party exhausts these objection procedures." Id. at 1015 (quoting 40 C.F.R. § 180.30(b)). This restriction on judicial review applies to "the establishment, modification, or revocation of a tolerance or exemption." Id. (quoting 40 C.F.R. § 180.30(a)(3)). On the other hand, the ESA "allows for 'citizen suits' claiming violations of the Act," and "provides for, but does not require, jurisdiction in district courts." Id. (citing 16 U.S.C. § 1540(c)). After the court reviewed the Ninth Circuit's holdings in two previous cases, it stated the rule of the case as follows: "District courts lack jurisdiction over claims against federal actions taken pursuant to a statute with an applicable statutory exclusive review provision." Id. at 1018 (citing California Save Our Streams Council, Inc. v. Yeutter, 887 F.2d 908 (9th Cir. 1989) and Wash. Toxics Coal. v. EPA, 413 F.3d 1024 (9th Cir. 2005). The court continued, "But absent a relevant jurisdictional provision, the district court may exert jurisdiction over the claim as provided for in the ESA." Id.

In the case at bar, the court held that the key inquiry was whether the plaintiffs' claims fell outside "the exclusive jurisdiction provision of the FFDCA." Id. If so, then the ESA's jurisdictional scheme could be applied and the court could hear the plaintiffs' claim. Id. If not, then the court could not exercise subject matter jurisdiction. Id. Ultimately, the court held that the claim "directly challenge[d] the establishment of tolerance levels for alfalfa hay and seed and therefore [fell] directly under the purview of the exclusive review provision of [FFDCA] section 346a(h)." Id. at 1020.

The case was decided on July 26, 2006.