The U.S. Department of Agriculture’s (USDA) new proposed rule for regulating plant-based agricultural biotechnology products, as drafted, is “fundamentally flawed” and could contribute to future trade disruptions, the National Grain and Feed Association (NGFA) and several other grain- and oilseed-based agribusiness associations said in a joint statement submitted on Aug. 6. 

“Our industry, and our farmer-customers emphatically need to avoid the costly trade disruptions that have been associated periodically with transgenic biotechnology,” wrote the NGFA, Corn Refiners Association, National Oilseed Processors Association, North American Export Grain Association and North American Millers Association. “If the U.S. government’s regulatory oversight approach to genome editing and other plant breeding innovation is out of step with the domestic food industry or America’s significant export markets, it will have perilous repercussions for the grain and oilseed value chain, including U.S. farmers.”

The groups stressed that they strongly support the use of biotechnology and plant-breeding innovation, including genome editing, for its role in providing an abundant, affordable and environmentally sustainable food, feed and energy supply for U.S. and global consumers. But the groups also stressed that a “cornerstone of U.S. agriculture’s competitiveness” is its ability to efficiently and cost-effectively market America’s agricultural abundance. “It is through this dual lens – support for technological innovation while ensuring the continued efficient marketability of crops in which it is used” – that the five organizations said the proposed rule needs to be viewed.

Under the proposed rule published on June 6, USDA’s Animal and Plant Health Inspection Service (APHIS) – which has authority to determine whether agricultural biotech traits pose a plant pest or noxious weed risk to the environment – would exempt most crops developed with gene-editing techniques from regulatory oversight. APHIS’s proposed rule states that such plants can be developed through traditional breeding techniques, making them unlikely to pose a greater plant pest risk than conventionally bred crops. The APHIS proposal also would empower crop developers to make a “self-determination” that their plant is exempt from APHIS regulatory oversight, without providing any notification to the agency. Under the proposed rule, technology providers would have the “option” to request written confirmation from APHIS that their self-determinations are valid.

The agribusiness organizations said such a broad self-determination approach “risks undermining consumer acceptance and international regulatory recognition of APHIS’s regulatory oversight.”

The organizations urged APHIS to amend its proposed rule to require all technology providers to notify the agency in advance before introducing gene-edited or other plant breeding innovation traits for commercialization – even those within APHIS’s expressly exempted categories – to provide needed transparency to the market and to consumers. Doing so would enable the agency to issue an official attestation that the trait does not pose a plant pest risk, “thereby providing an important tool to efficiently market U.S. agricultural products.”

The statement also reiterated NGFA’s long-held belief that obtaining international recognition or acceptance in significant U.S. export markets should be a precondition to avoid potential trade disruption before APHIS proceeds with a final rule.

Further, the groups said it would be ill-advised for APHIS to proceed with regulatory changes until its fellow federal agencies that operate under the U.S. “Coordinated Framework for Regulation of Biotechnology” – the U.S. Food and Drug Administration and the Environmental Protection Agency – issue rules or guidance on how they plan to address their respective oversight of genome editing and other plant breeding innovation technologies.

“Our members support the use of agricultural biotechnology and plant breeding innovation,” the organizations concluded. “However, for the member companies of our organizations, and the farmers and downstream customers they serve, the importance of efficiently and cost-effectively marketing U.S. farmers’ agricultural abundance without encountering recurring trade disruptions is paramount. We can ‘build it,’ but if U.S. and global consumers ‘don’t come’ (i.e., ‘don’t buy it’) the acceptance of this valuable technology could be imperiled and undermined irrevocably.”