In a major development for the agricultural biotechnology industry, the U.S. Court of Appeals for the Ninth Circuit has upheld the decision of the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service to deregulate Monsanto’s Roundup-Ready Alfalfa (RR Alfalfa). See Center for Food Safety v. Vilsack, No. 12-15052 (9th Cir. May 17, 2013). The Court rejected all of plaintiffs’ claims and affirmed in all respects the decision of the U.S. District Court for the Northern District of California. (Click here for a copy of the earlier decision and our summary of it). 

The Ninth Circuit’s decision is the latest in this long-running litigation that has attracted close attention in many circles throughout the country. APHIS initially granted non-regulated status to RR Alfalfa and supported its decision with an environmental assessment (EA) under the National Environmental Policy Act (NEPA). After that decision was reversed in litigation, APHIS prepared a more detailed environmental impact statement (EIS) under NEPA and again deregulated RR Alfalfa. Plaintiffs challenged the new deregulation decision and EIS on the same grounds, alleging violations of NEPA, the Plant Protection Act (PPA), and the Endangered Species Act (ESA).

The Ninth Circuit’s 31-page decision dismissed each of these claims and agreed with APHIS’ determinations. First, the Court found that the PPA requires analysis of only the “plant pest” risks identified by the statute and regulations, not a broader set of extrinsic concerns favored by plaintiffs. Second, the Court found that because RR Alfalfa is not a plant pest, APHIS had no jurisdiction to continue regulating the crop, and thus there remained no discretionary agency action to trigger consultation under the ESA. Finally, the Court upheld APHIS’ revised NEPA analysis, including APHIS’ rejection of “partial deregulation” alternatives after a finding of no plant pest risk.

This important decision has implications beyond RR Alfalfa. Special interest groups, including the plaintiffs in the RR Alfalfa litigation, have filed similar arguments in response to pending petitions for deregulation of other genetically engineered crops. APHIS and the industry can now draw confidence from the Ninth Circuit’s ruling in responding to such comments. Moreover, by refocusing the deregulation analysis on whether a new trait presents a “plant pest risk” as defined by statute and APHIS’ regulations, the Court’s decision has the potential to simplify and expedite agency decisions on genetically engineered crops going forward.

It is possible that the plaintiffs will seek to appeal this decision to the U.S. Supreme Court, which previously heard aspects of the prior challenge to APHIS’ first RR Alfalfa deregulation decision. APHIS has also been considering proposed revisions to its rules governing deregulation and commercialization of genetically engineered crops. These issues continue to warrant careful monitoring.