Planting of Monsanto’s “Roundup Ready” sugar beets—a form of beet genetically modified to be resistant Monsanto’s glyphosate-based weedkiller Roundup—was banned Friday, by a federal judge in San Francisco, until the U.S. Department of Agriculture complies with the requirements of NEPA, the National Environmental Policy Act.
The ruling came in a lawsuit filed by environmental and organic farming nongovernmental organizations. The NGOs challenged the decision of the Agricultural Department to deregulate genetically engineered sugar beets without preparing an Environmental Impact Statement. Deregulation means that the crop could be planted freely throughout the United States, with no further regulatory oversight from the USDA. Critics complain that the department has routinely determined that genetically modified crops pose no threat to the environment without conducting an adequate assessment of the environmental risks posed by these crops.
In September 2009, the Court agreed with these critics. It found that the department's decision to deregulate genetically modified beets without first completing an Environmental Impact Statement violated the National Environment Protection Act. Friday’s ruling:
► Vacated the USDA’s deregulation of biotech sugar beets; and
► Prohibited any future planting or sale pending the agency’s compliance with NEPA and all other relevant laws.
The ruling allows the sugar beets already in the ground to be harvested, but bars further planting until the Environmental Impact Statement is complete. USDA has estimated that such a statement may be ready by 2012.
This decision comes on the heels of an 7-to-1 judgment issued by the Supreme Court in June (J. Breyer took no part in the decision). In that decision, Monsanto Co. v. Geertsons Seed Farms, the Court overturned a similar ban, on the planting of genetically modified alfalfa, again until the USDA completed an Environmental Impact Statement. The majority concluded that the scope of the injunction—which prohibited any partial deregulation of the biotech alfalfa until the statement was completed—was too broad.
The federal ruling issued Friday took Geerstons into account. Specifically, the judge was careful to leave room for interim measures that might allow planting to proceed, so long as:
► Interim measures adequately protect the public’s interest in completion of a thorough environmental assessment; and
► No irreparable environmental harm occur in the interim.
Unlike gentically modified alfalfa, which had yet to be commercialized, genetically modified beets currently make up the vast majority of the United States' crop.
Among the benefits claimed for the new technology, are the assertions that genetically modified beets
require fewer herbicide applications to effectively control weeds. Fewer trips across the field mean reduced greenhouse gas emissions, reduced soil erosion, reduced soil compaction and enhanced water conservation. These sugar beets are helping growers manage weeds, improve productivity and lessen impacts on the environment, while preserving a sustainable and geographically diverse supply of sugar.
Supporting Monsanto, the sugar beet industry also asserts:
Independent scientific analyses conducted by internationally recognized laboratories showed that the sugar from Roundup Ready sugar beets, which are enhanced through biotechnology, is identical at the molecular level, to the sugar from other, comparably grown sugar beets.
Even if true, molecular equivalence of the ultimate food product says nothing about the impacts that genetically modified beet plants might have on their environment.
In particular, the technology’s critics contend that gene flow between genetically altered crops and conventionally grown food, or wild relatives, might result in irreversible genetic pollution. This concern has particular traction with sugar beets because genetically modified beets have been embraced by farmers and now representing about 95% of the sugar beet crop, accounting for about half the United States' annual sugar production.
In particular, the technology’s critics contend that gene flow between genetically altered crops and conventionally grown food, or wild relatives, might result in irreversible genetic pollution. This concern has particular traction with sugar beets because genetically modified beets have been embraced by farmers and now representing about 95% of the sugar beet crop, accounting for about half the United States' annual sugar production.
Genetically modified crops in the United States fall in a nether zone—a patchwork of federal regulation under the auspices of the Agriculture Department, the Environmental Protection Agency, and the Food and Drug Administration. In theory, no genetically engineered organism is approved for commercial use until its proponent has demonstrated that the GM organism conforms with the standards set by federal law. Unfortunately, the gap between theory and reality is significant. Part of the problem is that no regulatory agency has a clear statutory mandate to regulate agricultural biotechnology. As a result, no coherent, overarching government policies ensure that this new technology is safely explored and exploited.
The regulatory regime governing biotechnology crops dates back 25 years, to 1986, when the Office of Science and Technology finalized the Coordinated Framework for Regulation of Biotechnology.
The Coordinated Framework, a product of the sharply anti-regulatory Reagan administration, embraced the notion of “substantial equivalence”—that genetically modified organisms were functionally equivalent to their unmodified counterparts and should be treated accordingly. Thus, the Coordinated Framework proclaimed that no new laws were needed to respond to challenges posed by this new technology. Instead, regulatory authority was parceled out to various agencies based on their existing statutory authority.
At its most superficial, the regulatory regime established by the Coordinated Framework is very easy to describe: Food and Drug Administration is responsible for food safety; Environmental Protection Agency is responsible for microbes and pesticides; and the Animal and Plant Health Inspection Service, an agency within USDA, is responsible for all plants. Each agency concentrates on its own narrow piece of the genetic modification universe. With no single agency considering the full range of problems posed by genetically modified crops, regulatory gaps are inevitable. Critics assert that overarching safety questions go unexplored. Because of the assumption of substantial equivalence, the burden of proof is on the authorities to prove that a genetically modified organism is unsafe before they may impose use restrictions.
This ruling highlights a significant breaking point between the supporters and opponents of genetically modified crops.
Supporters point to molecular similarity of the endproducts, while opponents focus on differences in the plants themselves. The approval standards in the United States don’t require consideration of some key environmental concerns. This leaves big gaps and unknowns in the science.
Whether this lack of information as reason for concern or reason to relax depends significantly on one’s perspective about whether regulation should be precautionary or reactive.
Indeed, the United States and the European Union have differed sharply on this point, leading to a 3,000-plus-page World Ttrade Organization dispute resolution decision that, while it ruled for the United States, left this key question unanswered.
There is a difference between a demand for certainty, and a demand that appropriate questions be explored. The former focuses on results—do the fruits of exploration point so conclusively to a particular outcome that no other explanation is tenable. The latter addresses process—has the exploration been structured in a fashion likely to uncover relevant information. Both sets of demands can be obstructionist—the insistence of the Tobacco Institute insistence that the link between cigarettes and cancer was “not proven” is perhaps the best example of how a demand for certainty can be wielded to prevent otherwise reasonable social actions. However, to suggest that demands for more or more appropriate study are always or even predominantly obstructionist is to caricature wholly legitimate and important public participation in public decisionmaking.
The lack of a transparent, well-organized regulatory system threatens public trust in biotechnology and, more fundamentally, in government itself. The success of agricultural biotechnology depends fundamentally on society’s willingness to accept and consume food produced via this technology. This willingness hinges on the level of trust that the technology is being developed and used in a safe manner. Adequate regulatory oversight and information gathering are central to the future of the technology.