By Magdalina Gugucheva

In Monsanto v. Geertson, the Supreme Court of the United States removed a nation-wide ban on the continued sale and cultivation of Roundup Ready alfalfa, a Monsanto-developed genetically modified (GM) crop. The ban was originally implemented by a lower court in response to environmental concerns voiced by a coalition of plaintiffs. These groups included the Center for Food Safety, environmental activists, and farmers of conventional and organic alfalfa. While statements declaring victory have been issued by parties from both sides of the lawsuit, the Supreme Court opinion itself says actually very little about the future of biotech crop regulation. However, the decision is highly protective of the U.S. Department of Agriculture’s discretion and authority to make major regulatory decisions governing GM crops. Given the USDA’s history of ignoring environmental concerns and poorly enforcing existing environmental laws, biotech firms are likely to end up the biggest winners in this protracted litigation.

Facts & History

Roundup Ready crops are genetically modified (GM) to express a gene that allows the plant to survive exposure to the herbicide glyphosate (“Roundup”).

Glyphosate was introduced to the United States in the 1970s, and has been the most used herbicide in this country since at least 1980. The chemical is incredibly potent, capable of killing almost any plant sprayed. In addition to its potency, Glyphosate’s popularity primarily comes from how environmentally friendly it is compared to other pesticides. However, glyphosate can also be deadly to the crops it is sprayed on, usually requiring that it be used only at certain times during the growing cycle, and forcing farmers to use other, more harmful pesticides during the rest of the year.

Monsanto solved this problem by genetically engineering crops to include a gene from bacteria that makes the plants immune to Roundup’s toxic effects. Starting with soybeans in 1996, Monsanto’s list of Roundup Ready crops has grown to include cotton, canola, sugar beets and alfalfa, with wheat still in development.

Overview of Laws Regulating GM Crops

APHIS, an agency within the U.S. Department of Agriculture (USDA), has assumed authority to regulate GM crops, including Roundup Ready crops, by classifying them as “plant pests.” Under the Plant Protection Act (PPA), plants pests are considered “regulated articles,” and therefore any entity proposing to release these organisms into the environment must obtain a permit first. Obtaining a permit is difficult, however, and so long as GM strains remain regulated few farmers can actually plant them. The period when such permits are issued is called a “regulated release.”

After a regulated release, APHIS will usually accept petitions to grant the GM crop de-regulated status. Deregulation means firms and farmers can freely sell, plant and cultivate that GM crop. Or, APHIS can choose to de-regulate only in part, permitting more wide-spread planting and distribution without a permit while still requiring that farmers and handlers comply with containment protocols.

In making these de-regulation decisions APHIS is required to comply with the National Environmental Policy Act of 1969. This law mandates that federal agencies prepare an environmental impact statement (EIS) prior to undertaking any “major Federal action[n] significantly affecting the quality of the human environment.” What constitutes “major” can be open to interpretation, however, and often agencies like APHIS will complete less rigorous and timeconsuming “environmental assessments” (EAs) first. If an EA results in a “Finding of No Significant Impact,” an EIS is not required in order for the agency to implement the proposed decision – in this case, a decision to de-regulate a GM crop.

Current Roundup Ready Regulation & Controversy

Thus far, Roundup Ready crops de-regulated by APHIS include cotton, corn, canola, and sugar beet. In other words, the agency has found that these GM crops are environmentally safe. On the basis of findings from EIS reports prepared for these previous de-regulation decisions, APHIS determined that no EIS was necessary for Roundup Ready alfalfa. APHIS made a similar determination for Roundup Ready sugar beets on the basis of only an EA, a decision still being litigated in a San Francisco federal district court. Since the agency had determined Roundup Ready corn and cotton were environmentally safe, it reasoned that alfalfa should be, too.

Scientists and environmental rights activists disagreed. Aside from concerns that heavy glyphosate use may affect human endocrine function and interfere with reproduction, these groups cited two main environmental concerns with glyphosate usage. First, they were concerned that “gene flow” might occur, where the seeds or pollen from the genetically modified crop would spread and interbreed accidentally with wild, conventional or organic alfalfa strains. Once contaminated with the transgene, it can be extremely difficult and very costly, if not impossible, for organic and conventional farmers to restore their unmodified crop. Because many of these crops are sold or exported to buyers who refuse to purchase genetically modified foods, transgene contamination can be devastating to farmers.

The second, and arguably greater, concern over Roundup Ready crops is that the vastly increased use of glyphosate has encouraged the development and proliferation of Roundup-resistant weeds. Therefore, while APHIS may have assessed correctly that the introduction of a small number of Roundup Ready crops may not significantly harm the environment, as Roundup use expands to include a wider range of crops, its environmental impact is dramatically exacerbated. As more resistant weeds develop and proliferate, use of harsher and more toxic herbicides becomes necessary. As a result, any environmental benefits of Roundup use are lost.

Current Lawsuit

The Center for Food Safety, along with conventional alfalfa seed farms and other environmental groups, filed a lawsuit in 2007 claiming that APHIS’s EA did not adequately address environmental consequences stemming from gene flow and glyphosate-resistant weeds. Judge Breyer of the Northern District of California agreed, ruling that APHIS had violated federal law in fully de-regulating Roundup Ready alfalfa. Instead, the agency should have completed a thorough investigation of the crop’s potential environmental impact. Ordering APHIS to execute an EIS, the Court prohibited the agency from issuing any deregulation – even a partial one – until this comprehensive report was complete. The District Court also banned all sale and planting of GM alfalfa pending EIS completion. The Court did allow for the harvesting of any Roundup Ready alfalfa already planted in the U.S., not wanting to unfairly burden farmers who had originally relied on APHIS’s deregulation decision and purchased or planted seed. However, the Court did specify strict containment procedures for these crops.

Monsanto appealed, but the 9th Circuit agreed with Judge Breyer and upheld the order. The Supreme Court, however, disagreed with these previous decisions. Writing for the majority, Justice Alito said Judge Breyer’s bans exceeded the measures necessary to protect the environment. While upholding the District Court’s first order, which returned GM alfalfa to regulated status, the Supreme Court reversed the last three orders. It reasoned that APHIS should still be able to issue a partial, rather than whole, deregulation of GM alfalfa if it found no significant environmental impact would result. In other words, while a total deregulation might require an EIS, a partial deregulation – allowing widespread planting subject to containment restrictions – might not pose an environmental risk requiring a rigorous and time-consuming EIS. APHIS should be free to explore in a less intensive environmental assessment whether partial deregulation would pose a significant environmental impact.

Implications of the Supreme Court Decision

So what does this mean for the future of GM alfalfa? It’s hard to say just yet. In his dissent, Justice Stevens points out that the District Court’s opinion is itself a bit confusing. Perhaps, he argues, Judge Breyer does not purport to issue such broad restrictions on APHIS’s ability to partially deregulate, but only tries to specifically prohibit APHIS’s proposed deregulation. Justice Stevens explains that maybe Judge Breyer meant to allow more limited deregulation to go forward with only an EA. Thus, it’s possible that on remand Breyer will merely clarify this order, rather than making any changes.

The Supreme Court opinion does not leave much other room for Breyer to maneuver, however. Therefore, it is likely that when the case goes back to the District Court, he will only be able to issue an order preventing complete deregulation without an EIS. Any decision will likely leave it to APHIS to decide, subject to federal rulemaking protocol, whether and how much of a partial deregulation is appropriate. Furthermore, the Court’s decision will likely constrain the upcoming ruling on whether GM sugar beets can be planted while an EIS is pending for that crop.

In other words, the Supreme Court opinion defers most of the decision regarding GM alfalfa regulation to APHIS. And, according to Justice Alito, APHIS will likely issue a partial deregulation that closely mirrors the proposed order the agency gave Judge Breyer in 2007. This rule would allow a large expansion in the amount of Roundup Ready alfalfa planted nationwide, greatly exacerbating the potential problems of gene flow and herbicide resistance. Furthermore, APHIS’s limited resources make it unlikely the agency will able to inspect and enforce any containment rules it does implement. The agency has done a poor job of encouraging compliance among farmers and distributors in the past – even in the first two years of alfalfa de-regulation (before the lawsuit was filed), there was already evidence of gene flow to neighboring hay fields. Therefore, partial de-regulation might just amount to “full de-regulation subject to [unenforced] certain restrictions.”

Nevertheless, Justice Alito points out that environmental groups can file a separate lawsuit to challenge any future decision by APHIS to fully or partially deregulate. If they do file another suit alleging NEPA violations, environmental groups and farmers can request that the court issue a preliminary injunction – a temporary order halting the deregulation process until the lawsuit is resolved. This may happen; but again, it’s only a stop-gap on the road to what APHIS’s previous decisions suggest will be full deregulation. And while the Supreme Court’s decision in this case only explicitly addresses procedural issues – mostly about when and how courts can issue injunctions – the opinion does hint at the Court’s likely allegiances with respect to GM crops, biotech and environmental concerns more broadly. Thus, when future battles over GM regulation hinge on the actual merits of deregulation decisions, rather than procedure, it seems unlikely that today’s Court will be very sympathetic to concerns about the environmental impacts of these novel crops.

Magdalina Gugucheva is a J.D. candidate at Harvard Law School and an intern with the Council for Responsible Genetics.

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