USDA Pulls Problematic Biotech Reg Proposal to Re-engage with Stakeholders

USDA’s withdrawal of agriculture biotech regulations proposed last year will give the department, along with farmers and other stakeholders, time to improve the rules so they better foster innovation while meeting the demands of U.S. agriculture’s international customers, according to the American Farm Bureau Federation.

AFBF was joined this summer by 102 other agricultural organizations in a letter to Agriculture Secretary Sonny Perdue in which they noted the proposed revisions took some very constructive and bold steps in the right direction, but major changes were needed.

“USDA’s proposal had some positives, particularly how the department was viewing new breeding techniques, such as gene editing. However, there were also some concerns, such as how traditional biotechnology production practices might be regulated in the future and what that means for innovation and research and development,” explained Andrew Walmsley, AFBF biotech specialist.

USDA’s plan to start over on the regulations is an opportunity to make sure the department has the best regulatory approach for new breeding techniques, as well as for innovation in biotechnology and agriculture in general, Walmsley added.

Among some of the major concerns Farm Bureau and the other groups had with the proposal were researchers’ and developers’ inability to learn the regulatory status of new genetically engineered organisms without undergoing complex risk assessments. This would have provided little clarity about which products would be subject to regulation.

The requirement that risk assessments would be conducted for plant products based only upon the technology used in their production, rather than actual risk, was another problem.

With the shift of the regulatory burden from commercialization stages to research and development phases, each new GE plant variety would have had to undergo a complex risk assessment and comment period before a single plant could be planted in a small-scale field trial. In addition, the proposed assessment process likely would not have accommodated the scale of U.S. research and development, which could have resulted in many products being stuck in regulatory limbo.

Also at issue were the barriers to innovation that would have been raised under the proposal’s expansion of authority under Part 340, which would have created a redundant weed risk regulatory process. This process currently works under USDA’s Part 360 regulations.

Finally, USDA’s push for major changes to the current regulatory system would likely have had unintended consequences for other regulatory agencies, and domestic and international markets, and would have led to significant litigation risks.

Though USDA did not lay out a timeline for the biotech rule revamp, the department said it is committed to “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health,” so farmers and others are optimistic they’ll have ample opportunity to share their thoughts on a new proposal, Walmsley said.