By its nature, agricultural biotechnology is an enterprise that occurs in the environment. Today, approximately 330 million acres of genetically engineered crops have been planted by 14 million farmers in 25 different countries around the world.

The proliferation of agricultural biotechnology has not been without controversy. Faced with strident opposition to biotechnology from environmental groups like Greenpeace, the European Union has been notoriously reluctant to approve new genetically engineered crops, and a number of European countries have effectively banned them.

In the United States, regulatory authorities have been relatively open to new agricultural biotechnology. But opponents of genetically engineered crops in this country have found another way to fight the commercialization of new products—litigation. Most recently, potential litigants have targeted the process used by the USDA’s Animal and Plant Health Inspection Service (APHIS) to regulate the introduction of new agricultural biotechnology products.

APHIS, before it permits commercialization of a plant containing biotechnology, must comply with the National Environmental Policy Act (NEPA), a 40 year-old statute that requires federal government agencies to assess and publicize the potential environmental impacts of their actions. In several cases, plaintiffs have claimed that the agency’s NEPA review did not adequately address the ways in which genetically engineered crops might affect the environment. Taking a closer look at some of those cases reveals a great deal about plaintiffs’ strategies, and how litigation may affect the development of agricultural biotechnology.

A. Roundup Ready Alfalfa Litigation

In June 2005, APHIS granted a petition to deregulate a variety of genetically engineered alfalfa that was designed to resist application of Roundup herbicide. This was not the first time APHIS had approved a genetically engineered crop, or even the first time it had approved a Roundup-resistant crop. Nevertheless, in 2006 an anti-biotechnology group known as the Center for Food Safety filed a lawsuit in California claiming that APHIS did not conduct an adequate NEPA environmental review before granting the petition to deregulate Roundup Ready alfalfa.

It is uncertain why plaintiffs targeted Roundup Ready alfalfa, rather than another genetically engineered crop. It may be that they were searching for a friendly judicial forum, and the fact that alfalfa is commonly grown in California allowed them that opportunity. Perhaps it was simply a matter of timing and funding for the plaintiffs. Whatever the case, the district court in California ruled that APHIS had not complied with NEPA in granting the petition to deregulate Roundup Ready alfalfa, and subsequently prohibited the sale and planting of the product.

B. Roundup Ready Sugar Beet Litigation

Emboldened by their victory in the alfalfa case, the same plaintiffs filed a nearly identical suit against APHIS in January 2008 to challenge the deregulation of Roundup Ready sugar beets. Roundup Ready sugar beets were actually deregulated in 2005, before Roundup Ready alfalfa, and the technology was being used on the vast majority of the sugar beet acreage in the country when the Center for Food Safety filed its lawsuit in 2008.

Nevertheless, the sugar beet litigation followed the same pattern as the alfalfa case had. In September of last year, a federal trial court in California held that APHIS had violated NEPA by not conducting a sufficient review of the environmental impacts of Roundup Ready sugar beets. Suddenly, virtually ever sugar beet farmer in the country faced the possibility that a court would order him to switch from a genetically engineered crop to a conventional crop.

C. Potential Future Challenges

The Center for Food Safety now has two significant legal victories under its belt. It accordingly appears to have stepped up its efforts to prevent the introduction of new agricultural biotechnology.

In November 2008, the Center filed a letter with APHIS criticizing the environmental review associated with the proposed deregulation of genetically engineered papaya that resists ringspot virus. That petition was nonetheless granted by APHIS in September 2009.

In January and July 2009, the same group filed separate letters claiming that APHIS had not complied with NEPA in its environmental review of a genetically engineered variety of corn that was designed to facilitate ethanol production. To date, APHIS has not taken final action on that petition for deregulation.

In February 2009, the group again wrote a lengthy critique of APHIS’s environmental review procedures, this time in connection with a petition to deregulate a variety of corn that has been genetically engineered to resist two separate classes of herbicide. APHIS has not acted on that petition either.

Finally, in July 2009 and again earlier this year, the Center for Food Safety wrote letters claiming that APHIS did not comply with NEPA in approving field trials of a genetically engineered variety of eucalyptus. This is the Center’s most aggressive tactic yet, occurring before APHIS even begins the deregulation process.

D. Turning The Tide

In the short term, litigation involving new agricultural biotechnology crops may be inevitable. But continued victories by the opponents of biotechnology are not.

On April 27, 2010, the United States Supreme Court heard oral arguments in Monsanto v. Geertson Seed Farms, the Roundup Ready alfalfa litigation. By the end of June, the Court will rule in this seminal case.

One of the primary issues before the Supreme Court is whether the lower courts were right to prohibit the sale and planting of Roundup Ready alfalfa without considering the evidence that continued use of the product would not harm the environment. A second issue, which was discussed extensively during oral arguments, is whether a remand to the agency, rather than an injunction, is the appropriate remedy when a district court finds a NEPA violation. If so, the question could become what APHIS can do to allow commercial planting of a genetically engineered crop while the agency fixes its environmental review—a process that can take years. If the Court rules in favor of Monsanto on either or both of these issues, it will force plaintiffs like the Center for Food Safety to change their approach in other cases, including the pending sugar beet litigation. At the very least, the mere decision to hear the Monsanto case shows a recognition of the significant place that agricultural biotechnology has in the future of food, fiber and fuel production.

Even a victory for Monsanto in the Supreme Court, however, would not mean the end of efforts to block the implementation agricultural biotechnology through regulatory challenges and litigation. The Court is not going to address the quality of APHIS’s NEPA review, and as long as plaintiffs can successfully challenge the agency’s environmental documentation, they will be able to throw sand in the gears of the regulatory process.

Ultimately, the best way to guard against challenges to APHIS environmental reviews is to build a better—and more defensible—NEPA document. NEPA is a procedural statute, meaning that it simply requires an agency to document potential environmental impacts, not to avoid them at all costs. Moreover, courts are required to defer to the environmental conclusions reached by the agency, so long as those conclusions are well-documented. In the future, successful approval of new agricultural biotechnology depends on companies and APHIS working together to create NEPA reviews that are detailed and thorough, anticipating and rebutting potential attacks from groups like the Center for Food Safety. The NEPA reviews that result from such a cooperative process will discourage lawsuits, and be far more likely to withstand any legal challenges that may arise.