A December 2010 article in The New York Times reported Department of Agriculture Secretary Tom Vilsack’s views about a controversial proposal to deregulate genetically engineered (GE) alfalfa with geographic restrictions and isolation distances for cultivation of GE alfalfa crops.
Vilsack said that the proposal arose from experience with lawsuits about GE alfalfa and GE sugar beets in the past few years, which have pushed existing regulations to a breaking point. “The situation, as I see it,” he said, “is untenable for agriculture.” Farmers suffer economic losses, Vilsack said, in the midst of uncertainty about whether and when they can grow GE crops.
Sweet (But Transient?) Victory for GE Sugar Beets
In 2005, the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) deregulated Monsanto’s Genuity Roundup Ready sugar beets. APHIS had performed an Environmental Assessment and issued a Finding of No Significant Impact pursuant to the US National Environmental Policy Act (NEPA). As farmers quickly became acquainted with the GE sugar beets, a group of plaintiffs sued to block their cultivation. In January 2008, the Center for Food Safety, Organic Seed Alliance, Sierra Club, and High Mowing Organic Seeds filed a lawsuit at the US District Court for the Northern District of California alleging that APHIS should not have deregulated the GE beets. During September 2009, Judge Jeffrey S. White ruled that APHIS had violated NEPA, because the agency had deregulated the GE sugar beets without preparing an Environmental Impact Statement (EIS).
In January 2010, the Center for Food Safety filed a request for a preliminary injunction to prevent farmers from planting or cultivating GE sugar beets or GE sugar beet seeds until the USDA completes its EIS—around May 2012, according to APHIS’ estimate. In March 2010, Judge White denied the preliminary injunction request and allowed farmers to plant GE beets that season; five months later, the judge denied plaintiff’s request for a permanent injunction. However, the judge vacated the deregulation of Roundup Ready® sugar beets, while exempting GE sugar beet and GE sugar beet seed crops planted before that date.
Sugar beet farmers faced a grim problem. Farmers plant sugar beets on more than one million acres in ten states; about 95% of sugar beet acres are planted with GE sugar beets.
Meanwhile, APHIS issued permits to allow the cultivation of GE sugar beet stecklings, which are root stock usually planted in the fall, uprooted during the winter, and later replanted to produce seed. The agency’s action prompted another lawsuit. In December 2010, Judge White issued a preliminary injunction ordering the immediate destruction of 256 acres of GE sugar beet stecklings planted in September. Several weeks later, the US Court of Appeals in San Francisco put the destruction order on hold.
On February 25, 2011, the appellate court issued its final decision and found in favor of the defendants. The court vacated the preliminary injunction and ordered that the APHIS permits be given full effect. “The undisputed evidence indicates that the stecklings pose a negligible risk of genetic contamination, as the juvenile plants are biologically incapable of flowering or cross-pollinating before February 28, 2011, when the permits expire,” wrote Judge Sidney R. Thomas. The judge said that the irreparable harms advanced by the plaintiffs hinged on future APHIS decisions. “The alleged irreparable harms are little more than an expression that ‘life finds a way.’ Michael Crichton, Jurassic Park 159 (Ballantine 1990). However, an invocation to chaos theory is not sufficient to justify a preliminary injunction.”
Judge Thomas closed his opinion with a quote from the Bard. “As we have noted, this appeal presents a thin slice of a larger litigation,” the judge wrote. “Perhaps, in the end, the entire controversy will be resolved, and we can say that the ‘fair discourse hath been as sugar, [m]aking the hard way sweet and delectable.’ William Shakespeare, Richard II, act 2, sc. 3. Needless to say, given the course of the litigation, that is unlikely.”
As the judge predicted, the tempest surrounding GE sugar beets still rages. In February, APHIS announced that, based upon its environmental assessment, the agency would partially deregulate GE sugar beets so that farmers could plant them while APHIS completed its EIS. The interim measure comes with various restrictions to avoid contamination with conventional crops and a requirement to identify seeds of GE sugar beets throughout the production process. Farmers who fail to meet APHIS’ conditions may face civil or criminal penalties. A representative of Earthjustice promised to file another lawsuit to thwart the partial deregulation.
What the Hay?
Monsanto owns the patent rights to Roundup Ready alfalfa and licenses the technology to Forage Genetics International, the exclusive developer of Roundup Ready alfalfa seed. In May 2003, Monsanto and Forage Genetics submitted a petition to the USDA requesting nonregulated status for two Roundup Ready alfalfa lines, J101 and J163. After APHIS prepared an Environmental Assessment, the agency issued a Finding of No Significant Impact in June 2005. APHIS decided that it was unnecessary to prepare an EIS and unconditionally deregulated the GE alfalfa.
In early 2006, the Center for Food Safety, several other nonprofit organizations, and alfalfa growers filed a lawsuit against the USDA in a California US District Court that challenged APHIS’ decision to deregulate the Roundup Ready® alfalfa lines. The plaintiffs alleged that USDA’s deregulation of GE alfalfa violated NEPA, because cultivation of the GE alfalfa would pass on the glyphosate tolerance gene to conventional alfalfa, and this would be a significant environmental impact.
In February 2007, Judge Charles R. Breyer held that APHIS had violated NEPA by deregulating Roundup Ready® alfalfa without first drafting an EIS. During March, the judge issued a preliminary injunction order prohibiting all planting of Roundup Ready® alfalfa and all sales of Roundup Ready® alfalfa seed after March 30, 2007, pending the issuance of a permanent injunction. Farmers who had already purchased GE alfalfa seed could plant the seed, and those who had already planted Roundup Ready® alfalfa could harvest, use, and sell the GE alfalfa.
Following a hearing, Judge Breyer vacated APHIS’ June 2005 regulation decision. He ordered APHIS to prepare an EIS before the agency decided again about Monsanto’s deregulation petition, and issued a permanent injunction prohibiting the planting of any Roundup Ready® alfalfa in the United States after March 30, 2007, pending the government’s completion of the EIS and decision on the deregulation petition. The judge instructed APHIS to issue an administrative order detailing mandatory practices for future harvesting or sale of about 260,000 acres of GE alfalfa already planted.
In August 2007, the USDA, Forage Genetics, Monsanto, and a number of alfalfa growers filed an appeal with the Ninth US Circuit Court of Appeals in San Francisco. The defendants asserted that the injunction was too broad. They also argued that the district court should have held a further hearing before enjoining future planting. A three-judge panel issued a decision in September 2008: Two of the three judges upheld the ban on selling and planting GE alfalfa seed pending the completion of an EIS.
Forage Genetics, Monsanto, and two alfalfa farmers appealed the decision to the US Supreme Court, arguing that the lower courts failed to show a likelihood of irreparable harm to justify the issuance of the injunction. In June 2010, the Court reversed the appellate court, stating that the injunction barred APHIS from instituting any form of deregulation of GE alfalfa pending completion of the EIS. Before a court grants a permanent injunction, a plaintiff must show that it has suffered an irreparable injury. Here, the plaintiffs cannot show that they will suffer irreparable injury if APHIS is allowed to proceed with any partial deregulation, the Court said, because if and when APHIS pursues a partial deregulation that arguably runs afoul of NEPA, the plaintiffs may file a new suit challenging the action. Also, a partial deregulation need not cause plaintiffs any injury at all. Depending upon APHIS’ conditions for cultivating the GE alfalfa, the risk of gene flow could be virtually nonexistent. The upshot of the decision was that APHIS could decide growing conditions for GE alfalfa pending completion of the EIS.
The Supreme Court decision prompted a letter to USDA Secretary Tom Vilsack from 75 Members of Congress, who requested that farmers be allowed to plant GE alfalfa during the upcoming fall. Because farmers have not been able to use GE alfalfa during the EIS process, they wrote, farmers have lost more than $250 million in revenue and face significant additional losses if they cannot plant inventoried seed during the fall 2010 planting season. However, APHIS did not issue interim deregulatory measures; the agency focused on completing the EIS and possibly decided to avoid a new lawsuit on interim rules.
APHIS had offered its draft EIS for public comment in December 2009. The agency considered two alternatives: It would either grant nonregulated status to the two lines of GE alfalfa or maintain the status as regulated articles. APHIS analyzed the alternatives with regard to their potential impacts on gene flow between the GE alfalfa and conventional alfalfa, weed development, herbicide use, possible effects on conventional and organic alfalfa markets, human health and safety, effects on the physical environment, and other factors.
One year later, APHIS released its 2,300-page EIS. Now, the agency considered three options: maintain GE alfalfa’s status as a regulated article, grant nonregulated status to GE alfalfa, or, in a policy reversal, deregulate GE alfalfa while imposing geographic restrictions and isolation distances for GE alfalfa production. According to Forage Genetics, the proposed restrictions would ban the cultivation of GE alfalfa on about 50% of current alfalfa acreage in Western states and about 20% nationwide.
The new restriction proposal prompted a letter from the National Association of Wheat Growers and five other farm groups to the director of the White House Office of Science and Technology. The USDA’s new proposal could undermine the US government’s science-based regulatory system, they said. Critics voiced concern that the new policy would be applied to other GE crops. Representative Frank Lucas (R-Okla.) and Senators Saxby Chambliss (R-Ga.) and Pat Roberts (R-Kan.) also urged a return to a science-based regulatory system in their own letter to Vilsack. While acknowledging Vilsack’s concern that “courts may unwisely interfere in normal commerce,” the Congressmen called the geographic restriction proposal “equally disturbing since it politicizes the regulatory process and goes beyond your statutory authority and indeed Congress’ intent in the Plant Protection Act (PPA). The PPA requires the Secretary to make a scientific determination if the product under review is a plant pest (7 U.S.C. 7711(c)(3)). If the final decision is that the product is not a plant pest, nor would the movement of the product in question impose the risk of dissemination of a plant pest, then USDA has no authority to impose further restrictions (7 U.S.C. 7712(a)).”
During late January 2011, Vilsack announced that his agency had scuttled the controversial plan. The USDA would authorize the unrestricted commercial cultivation of GE alfalfa.
The decision to deregulate GE alfalfa marked a new, but not final, chapter. The Center for Food Safety announced its disappointment with the decision. Characterizing the USDA as a “rogue agency in its regulation of biotech crops,” the group promised to sue the USDA for the “improper and illegal approval.”
References
1. APHIS (2011) Roundup Ready Alfalfa. APHIS website.
2. Batra, Karen. (2010) Congressional Leaders Ask Vilsack to Allow Farmers to Plant Biotech Alfalfa. BIO website, July 20, 2010.
3. Center for Food Safety et al. v. Thomas J. Vilsack et al., Case No. 10-17719 (February 25, 2011).
4. Hubbard, Kristina. (2010) Federal Court Orders Destruction of GE Sugar Beet Crop. Salem-News.com website, December 2, 2010.
5. Lucas, Chambliss, Roberts: USDA Sending Mixed Signals on Genetically Engineered Alfalfa. House Committee on Agriculture website, January 19, 2011.
6. Pollack, Andrew. (2011) U.S. Approves Genetically Modified Alfalfa. The New York Times, January 27, 2011.
7. Tomson, Bill. (2010) USDA Seeking Approval of Genetically Modified Sugar Beets. Wall Street Journal, November 2, 2010.
8. USDA Decision on GE Alfalfa Leaves Door Open for Contamination, Rise of Superweeds. The Center for Food Safety website, January 27, 2011.
9. Voosen, Paul. (2010) USDA Reverses Course, Weighs Restrictions on Biotech Alfalfa. The New York Times, December 16, 2010.
Contact:
Phill Jones
Biotech-Writer.com
PhillJones@nasw.org
