GMO Regulatory Practices: Food for Thought
by Robert Ennesser
Genetically Modified Organisms, or GMOs, are often considered to be a fruit of our achievement in genetic engineering. Inventors made waves in 2004 with the first GMO pet, Glofish®, fluorescent zebra fish-like pets that literally glow. The proponents of GMO crops assert that they will help feed people around the globe by producing crops in more areas and larger quantities. But there are also potential downsides of GMOs. First, genetically-engineered crops can contaminate conventional crops, such as through seeds spread by wind. Second, many crops are engineered to be resistant to the common herbicide glyphosate, but there is evidence of an increasing prevalence of weeds resistant to glyphosate.
There is a regulatory agency in place to address concerns raised by GMO crops. Under the Plant Protection Act (PPA), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) regulates the introduction of genetically engineered plants (which it terms "plant pests") within the United States. A manufacturer may petition APHIS if it believes its genetically engineered plant is not a "plant pest" and should be available to be freely sold and planted (deregulated). The deregulation process requires APHIS to analyze the potential impact of the GMO on the environment pursuant to the National Environmental Policy Act of 1969 (NEPA). Generally, APHIS files a brief environmental assessment (EA), but if it determines that the seeds could significantly affect the environment, APHIS must complete a detailed environmental impact statement (EIS).
Roundup Ready® Alfalfa (RRA) is a genetically-modified alfalfa made by the agricultural company Monsanto. RRA is engineered with a gene that makes the alfalfa resistant to glyphosate, the herbicide used in Roundup® Weed & Grass Killer. APHIS initially considered RRA a "plant pest" and therefore regulated its sale and planting. Monsanto petitioned APHIS and was granted a decision to deregulate RRA in June 2005. APHIS completed an EA for RRA in June 2005, reaching a "finding of no significant [environmental] impact" after overseeing nearly 300 field trials over eight years as well as public comments. In February 2006, Geertson Seed Farms, Trask Family Seeds, and several environmental agencies filed a complaint in the Northern District of California alleging APHIS violated the National Environmental Policy Act of 1969 (NEPA) by failing to prepare an EIS before deregulating RRA. The plaintiffs argued that the EA inadequately addressed that (1) the resistance gene may be spread either through the pollination of conventional plants by RRA plants or mixing of the two seed-types and (2) the increased use of glyphosate can both lead to the development of tolerant weeds and have additional unknown consequences. The Northern District of California agreed and granted an injunction, enjoining (preventing) the sale and planting of RRA seeds after March 30, 2007. APHIS asked the District Court for a remedy that, in effect, would allow limited and temporary planting and harvesting of RRA (partial deregulation) until APHIS could complete the EIS needed for complete deregulation, but the request was refused. The Ninth Circuit affirmed the decision in June 2009 and Monsanto subsequently appealed to the Supreme Court.
In Monsanto Co. v. Geertson Seed Farms, the Supreme Court reversed the ruling of the District Court and found the injunction was too broad. Applying a four-factor test from eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388, 391 (2006), the Court determined the factors necessary to permanently enjoin an activity did not support the District Court's injunction prohibiting partial deregulation. The Supreme Court held judicial review of any partial deregulation is premature until APHIS actually partially deregulates RRA. The District Court barred APHIS from pursuing any deregulation, no matter how limited in scope, but the Supreme Court found a complete injunction was too broad.
Monsanto "won," but still has an uphill battle before RRA seeds may be widely distributed. APHIS completed a draft EIS of RRA in November 2009, which concluded that RRA was "unlikely to pose a plant pest risk." Geertson Seed Farm’s responded to the RRA draft EIS in January 2010, arguing incorrect conclusions were drawn from the data and conventional alfalfa gives a greater return than genetically-engineered varieties. The final report has yet to be issued.
Similar to RRA, APHIS had not prepared an EIS on the genetically modified sugar beets. In a challenge from organic seed growers and conservation groups, Judge White of the Northern District of California found that the EA did not address the effects of gene transmission from genetically modified seeds on conventional farmers and consumers and ordered an EIS be completed. In preparation, APHIS accepted public comments between May 28, 2010 and June 28, 2010. Any effects on farmers' ability to grown modified sugar beets will not be felt until next year because on March 16, 2010, Judge White ruled that Monsanto retained the right to have farmers continue planting Roundup Ready® sugar beets this season. The next hearing is set for July 9, 2010.
APHIS regulates genetically-engineered plants and has the responsibility to evaluate any environmental impact of such plants, however, the procedures currently in place are inefficient and do not adequately assess the environmental impact from the beginning. In the cases of both genetically-engineered alfalfa and sugar beets, the GMOs were labeled "plant pests" by default, the manufacturer petitioned for deregulation, APHIS completed a brief EA, and both GMOs were consequentially allowed to be sold and planted without restriction. In both cases, however, subsequent litigation resulted in an order to perform an EIS. This suggests an EA was not sufficient to fully realize the impact of genetically-engineered crops on the environment. While the EA for RRA was only 29 pages and the draft EIS neared 1500 pages, in cases involving genetically-engineered crops it is more efficient if APHIS initially completes an EIS. Withholding a decision until a complete analysis is completed is akin to the system already in place for obtaining FDA approval for new drugs. This method would allow APHIS to accurately assess the environmental impact of the GMO before any seeds are available in the marketplace.