Summary of a Recent
Judicial
Development in
Biotechnology
Permitting Requirements for Genetically
Modified Plants
Eric PendergrassNational AgLaw Center Graduate Assistant
In Center for Food Safety v. Johanns, 451 F.Supp.2d 1165 (D. Haw. Sept. 1, 2006), the United States District Court for the District of Hawaii held that the Animal and Plant Health Inspection Service (APHIS) violated the Endangered Species Act (ESA), 16 U.S.C.A. § 1536(c)(1), and the National Environmental Policy Act (NEPA), 42 U.S.C.A. § 4332, by failing to conduct environmental impact studies before issuing permits for the production of genetically engineered, pharmaceutical-producing plant varieties (GEPPV). Also, the court held that issues relating to the promulgation of regulations concerning the GEPPV program were not yet ripe for review because no final agency action was taken. Center for Food Safety, 451 F.Supp.2d 1165, at 1171.
Four companies sought permits from APHIS to allow them to plant pharmaceutical-producing experimental varieties of corn and sugarcane. Id. at 1170. The plants contained genetic modifications enabling them to produce hormones, vaccines, and proteins used to fight human illness such as HIV, Hepatitis B, and cancer. Id. APHIS issued the permits for planting on several islands in Hawaii, which is also home to over 300 endangered species. Id.
The plaintiffs claimed that these crops posed unknown risks to animals, could cross-pollinate with other plants, and could contaminate the food supply. Id. at 1171. The court ultimately adopted the plaintiff's arguments and held that APHIS did violate the ESA and the NEPA because it did not conduct an environmental assessment or obtain an environmental impact statement for the effect that these plants would have on the surrounding ecosystem. Id. at 1181. The argument that APHIS could not have violated the ESA and NEPA because no damage actually occurred as the result of their inappropriate action was rejected by the court in light of the fact that the agency's action directly contradicted a congressional mandate. Id. at 1182.
The plaintiffs also claimed that APHIS violated the Administrative Procedures Act, 5 U.S.C.A. § 551(13), by not acting upon its request to promulgate regulations relating to its GEPPV program. Center for Food Safety, 451 F.Supp.2d 1165, at 1171. The court, however, concluded that no "final agency action" had taken place to establish a program because APHIS had only established a set of policies and procedures to guide its internal operations. Id. at 1189. "[T]hese procedures and protocols do not rise to the level of "final agency action" for purposes of NEPA [or the ESA] unless the agency engages in some activity with some direct impact on the environment." Id. Consequently, the court determined the failure of APHIS to act upon the plaintiffs' petition to promulgate regulations relating to GEPPV to not be ripe for judicial review. Id. at 1190.
The case was decided on September 1, 2006; this summary was posted July 20, 2007.