WASHINGTON, April 27, 2016 - The Agriculture Department’s plan for a “radical” overhaul of the way it regulates biotech crops risks disrupting exports of U.S. farm commodities unless the changes are coordinated with importing countries, agribusiness groups say. 

The organizations also are rejecting a proposed broad definition of biotechnology that would include gene editing, going well beyond the traditional technique of inserting genes from one species into another. 

In joint comments on the plan to USDA, trade groups that represent companies such as Archer Daniels Midland Co. and Cargill Inc. that export grain, oilseeds and other products said that the proposal was “premature and potentially harmful to U.S. agriculture” because of the possible impact on trade. 

The USDA plan, outlined in a 14-page document published in February, is intended to accelerate the development of new crop traits that USDA believes pose little risk to the environment, with the side benefit of making it easier for public researchers and small companies to get their ideas to market. The new system USDA envisions would end or at least curtail what scientists consider unnecessary, redundant reviews of essentially the same traits. 

The document, prepared by USDA’s Biotechnology Regulatory Services, a unit of the Animal and Plant Health Inspection Service (APHIS), lays out in broad terms a new two-step process for analyzing new crop traits and deciding which ones would be subject to regulation. Although the definition of biotechnology is broad, the expectation is that some techniques would be exempted from regulation. 

The grain and oilseed traders have been pushing the administration for months to ensure that any changes in regulation are coordinated with other countries, citing the impact of China’s rejection of imports after discovering a Syngenta corn variety that hadn’t been approved there. 

In the joint comments, the Corn Refiners Association,  National Grain and Feed Association, Corn Refiners Association, National Oilseed Processors Association, North American Export Grain Association and the North American Millers Association said going forward with the overhaul nolw could harm U.S. agriculture. 

“To create a truly workable biotech regulatory framework for the future, APHIS necessarily must take the necessary time and make the necessary effort to address the challenge of achieving regulatory coherence and compatibility in the global market,” the groups said. 

An APHIS spokesman did not immediately respond to a request for comment on the industry's concerns. 

With the China experience in mind, the grain and oilseed traders also asked APHIS to create a new approach for safeguarding exports through creation of a “conditional deregulation” category for products that don’t present a plant pest or noxious weed risk but lack necessary approvals in export markets. The category also would cover novel crop traits that could result in disruptions to domestic or export markets. 

Biotech companies that receive such conditional approvals would have to implement “stewardship plans” to manage the products and take responsibly for them if the plans “fail to protect the value of U.S. crops.”

In other comments, the National Council of Farmer Cooperatives pushed USDA to exempt gene editing techniques from the definition of biotechnology, saying they offered “significant opportunities” for crops that have not benefited from genetic engineering before. 

“New gene editing tools offer a precise alternative to mutagenic techniques, which have been safely used by plant breeders for almost a century, to create novel alleles (alternative forms) of native genes,” NCFC said. 

The Biotechnology Industry Organization, which represents Monsanto Co. as well as many smaller companies, said in its comments that the definition was “very broad” and had “no articulated connection to actual risk."

The agency has no legal authority to regulate biotech products unless they are considered plant pests, noxious weeds or could lead to the introduction of a plant pest or noxious weed, BIO said. 

The group said the broad overhaul being proposed was unnecessary. APHIS should instead make “surgical” changes “focused on addressing specific issues, rather than by proposing or undertaking a radical departure from the current system,” BIO said. 

The American Seed Trade Association echoed many of BIO’s concerns. The biotechnology definition “would require pre-market regulatory review of many modifications that could be achieved through conventional breeding,” the group said. 

Critics of biotechnology don't think the department’s proposal goes far enough. Some comments pressed the agency to take into account the impact of biotech crops on organic producers. Friends of the Earth, for example, said biotech companies should be held liable for “contamination” of non-GMO crops. The group also called for mandatory safety testing of all genetically engineered organisms.

The Center for Food Safety, which has frequently challenged USDA biotech approvals in court, applauded the broad definition of biotechnology, but the group said APHIS failed to use the definition as a regulatory trigger.

CFS says that all genetically engineered organisms should be regulated as plant pests or noxious weed risks. The group also said the agency should pay special attention to herbicide-resistant (HR) crops. “Based on the continuing large number of field trials and recent deregulations of HR crops with resistance to multiple herbicides, this class of GE crops will also dominate the future of agricultural biotechnology.”

Food and Water Watch submitted a petition that also emphasized the concerns about herbicide usage and the impact on organic farming.

The USDA document lays out four alternatives for future regulation, the second of which is the plan APHIS outlined to interest groups last fall. The other alternatives are essentially throwaway plans. One would leave the current system unchanged, another would replace it with a much more stringent system, and the third would essentially deregulate biotechnology.

The USDA docket on the EIS, with public comments, is here. 

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