A U.S. Department of Agriculture decision on biotech alfalfa could mark an unprecedented federal policy change for genetically engineered crops, more than 15 years after their introduction to American agriculture.

The debate centers on biotech alfalfa, designed to resist a popular herbicide. USDA approved the product in 2005, after finding that the product did not present a plant pest risk under the Plant Protection Act, and after conducting an environmental assessment under the National Environmental Policy Act (NEPA).

But soon after its deregulation and commercialization, and broad adoption by American farmers, opponents claimed that the USDA failed to conduct a full analysis of potential environmental impacts under NEPA and filed lawsuits to stop its planting. In 2007, a Federal judge called for a more lengthy review and preparation of an environmental impact statement (more detailed than the environmental assessment it conducted) from the USDA.

The Department’s newest environmental review, issued on Dec. 23, 2010, again found no evidence of harm from biotech alfalfa. As a part of this environmental impact analysis, USDA proposed three options for action: 1) No deregulation of GE alfalfa; 2) complete deregulation of GT alfalfa; or 3) Partial deregulation of alfalfa with certain government mandated measures to segregate GE production from organic production. Under NEPA the public is granted a 30-day period of public review, which is drawing input from both biotech supporters and critics. Some of the mandatory conditions suggested by USDA include: 1) prohibiting planting of GE alfalfa in certain parts of the country, and 2) establishing excessive buffer zones between GE and organic production sites.

A decision in favor of partial deregulation with planting restrictions would render about 20 percent of the alfalfa acres in the U.S. off limits to farmers wanting to plant biotech alfalfa. The number increases to 50 percent for alfalfa production in Western states.Not only does USDA not have legal authority to impose mandatory conditions when there is no plant pest risk, but such action would also set a precedent to use criteria other than science to drive the decisions about future approvals and even make products already deregulated vulnerable to similar challenges in the judicial system.

The result would be a significant dampening of the positive impact biotechnology crops have contributed to employment opportunities and increased productivity across America’s rural economy.

The pending USDA decision, expected to occur before the end of January, raises important questions about the future of agriculture biotechnology. For example, what is the greatest challenge to a science-based regulatory system? What government regulatory policy, if any, is needed to facilitate bringing new biotechnology innovations to market more quickly?

Scientific experts weigh in

We asked a few of the Council for Biotechnology Information’s (CBI) experts to weigh in.

“The greatest challenge to the science-based regulatory system is that it will be – some would say has been – drawn away from solid science in decision-making by a number of distractions, and it needs to return to judging the facts and evidence impartially and apolitically,” said Dr. Bruce Chassy, professor, Department of Food Science & Human Nutrition, at the University of Illinois at Urbana-Champaign. “Since from a scientific perspective there are no new risks it makes no scientific sense for USDA, EPA and FDA to single out this one breeding technology for regulation while other less precise technologies go unregulated.”

Dr. Wayne Parrott, professor, College of Agricultural and Environmental Sciences, at the University of Georgia, points out the need for an updated government regulatory system that facilitates innovation. “First, the current regulations are frozen in time, and do not make use of all the additional information on safety that has been gathered in the past 24 years since their 1986 inception. Such information justifies simplified approval protocols, the issuance of a categorical exclusion for transgenic products from NEPA [National Environmental Policy Act], and the recognition of many transgenic products such as GRAS.”

Dr. Terry Etherton, professor, Animal Nutrition and head of the Department of Dairy and Animal Science, at Penn State University, agrees that the science-based regulatory system faces the challenge of politicization. “The fact that many elected officials are ‘listening’ to absurd regulatory policy oversight ideas being pushed by opponents of agricultural biotechnology, and in the case of the ‘coexistence plan’ conceived by Ag Secretary Vilsack, are dismissive of the scientific evidence base.” To promote innovations in biotechnology, he proposes, “we need a complete overhaul and harmonization (i.e., across agencies) of the regulatory review process that is overseen by federal agencies that are responsible for approving animal and plant biotechnologies.”

Dr. Kent Bradford, director Seed Biotechnology Center, at the University of California-Davis, said federal policy makers should consider the contributions of agriculture biotechnology, specifically in the area of environmental sustainability, before making a regulatory decision. “The products of agricultural biotechnology currently in use have reduced pesticide and fuel use and have encouraged the adoption of conservation tillage methods. Products in the development pipeline promise to reduce fertilizer and irrigation requirements and improve nutritional quality. Why are we imposing a regulatory bottleneck that is blocking the commercialization of these products?”

If you're interested in talking to these scientists, please contact Ariel Gruswitz at 202-962-6672 or agruswitz@bio.org.