The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) granted "non-regulated" status to Roundup Ready (RR) alfalfa on January 27, 2011, ending all APHIS regulation of the seed. For the first time since its introduction, farmers will be free to plant, harvest and distribute RR alfalfa unrestricted by APHIS oversight or regulation when the decision goes into effect with its publication in the Federal Register.
According to its Record of Decision, APHIS found that RR alfalfa does "not present a greater plant pest risk than other conventional alfalfa varieties" and that it would therefore "not be consistent with APHIS' regulatory authorities" to continue its regulation. In reaching its determination, APHIS reviewed the final Environmental Impact Statement (EIS), the plant pest risk assessment, public comments, and met with a diverse group of industry shareholders concerned with the coexistence of genetically engineered, organic and conventional seeds.
In its decision, APHIS notes that a plant pathogen was used in the development of RR alfalfa, but that the plants "are not infected by this organism nor do they contain genetic material from pathogens used as a donor organism that can cause plant disease." APHIS also concluded that although gene flow could occur through a transfer of pollen, such as by insect pollinators or accidental seed mixing, the National Alfalfa and Forage Alliance (NAFA) and the Association of Seed Certifying Agencies have developed management practices to limit the presence of genetically engineered traits in conventional seed lots to levels that are between 0.5% and "not detectable by standard industry tests."
In addition to deregulating RR alfalfa, APHIS will also:
- Reestablish two USDA advisory committees (the Advisory Committee on Biotechnology and 21st Century Agriculture and the National Genetic Resources Advisory Committee) to ensure the availability of high quality seed and that growers have the tools necessary to support their production choices;
- Refine and extend existing gene flow models in alfalfa;
- Request proposals for handling and detecting transgenes in alfalfa seeds; and
- Provide voluntary, third-party verification of industry-led stewardship initiatives.
APHIS's decision on RR alfalfa comes after years of regulation and litigation that worked its way all the way up to the Supreme Court. It began on April 16, 2004, when Monsanto Company and Forage Genetics International petitioned APHIS for a determination of non-regulated status of its RR alfalfa. In reviewing the petition, APHIS prepared an Environmental Assessment (EA) considering the potential risks the seed posed and the environmental impact its deregulation might have. Based on the EA, APHIS determined that the seed did not pose a significant environmental harm and on June 14, 2005, granted it non-regulated status.
A few months later, the Center for Food Safety and organic alfalfa growers filed a lawsuit in the United States District Court for the Northern District of California challenging APHIS's decision and seeking an injunction prohibiting further planting and harvesting of the seed.
On February 3, 2007, the district court issued an opinion holding that APHIS violated the National Environmental Policy Act (NEPA) by failing to perform a more detailed and involved EIS, and consequently vacated its decision. Specifically, the court found that APHIS failed to adequately analyze the possibility of cross-pollination and the potential economic effects it might have on organic farmers. The court found that the potential contamination could lead to a "significant environmental impact" which necessitated an EIS before the seed could be deregulated. The court therefore enjoined all further sales and planting of RR alfalfa anywhere in the United States until APHIS completed an EIS. It did, however, allow those already planted to be harvested and sold. The Ninth Circuit Court of Appeals affirmed the decision in all respects.
In 2010, the Supreme Court granted certiorari and reversed the district court's injunction in its first case to consider genetically modified seeds. In a 7-1 opinion, the Supreme Court ruled that the plaintiffs had not satisfied any of the four-factors a court weighs in granting an injunction. The Supreme Court found that: (1) the plaintiffs would not be irreparably harmed without the injunction; (2) other legal remedies were adequate because RR alfalfa was still regulated; (3) a balance of hardships did not favor the injunction; and (4) the injunction would harm the public interest. In essence, the Supreme Court found the district court's injunction was unnecessarily duplicative of its decision to vacate APHIS's deregulation of RR alfalfa. The Supreme Court, however, did not consider the district court's ruling vacating RR alfalfa's deregulation and consequently RR alfalfa was still a regulated article pending APHIS's completion of an EIS.With the recent completion of the EIS, this case has come full circle as APHIS has once again determined that the deregulation of RR alfalfa does not pose a significant environmental harm and granted it non-regulated status. In response, the Center for Food Safety has once again pledged to challenge APHIS's decision in the courts.