Proposed revisions to the U.S. Department of Agriculture’s biotechnology regulations take some very positive and bold steps in the right direction, but major changes are needed to ensure that the new rules encourage innovation, according to a letter from more than 100 agricultural organizations.
“We are supportive of USDA’s efforts to modernize its regulations, ensuring they are up to date with the best-available science and utilize the more than 30 years of experience USDA has in reviewing the safety of these crops,” the groups wrote in a recent letter to Agriculture Secretary Sonny Perdue.
The groups also noted their appreciation for USDA’s strong position regarding the exclusion of products of new breeding methods, such as gene editing, from the proposal. Many of the products developed using these new methods are strikingly similar to those developed using more traditional plant breeding methods.
Despite these positive aspects, there are several shortcomings holding the groups back from supporting the proposal as a whole.
Among the major concerns are researchers’ and developers’ inability to learn the regulatory status of new genetically engineered (GE) organisms without undergoing complex risk assessments, providing little clarity about which products will 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, is another problem. “This runs counter to USDA’s 30-plus years of experience regulating biotechnology,” the groups noted.
With the shift of the regulatory burden from the commercialization stages to the research and development phases, each new GE plant variety will have to undergo a complex risk assessment and comment period before a single plant can be planted in a small-scale field trial. In addition, the proposed assessment process will likely not accommodate the scale of U.S. research and development, which could result in many products being stuck in regulatory limbo.
Also at issue are the barriers to innovation that would be raised under the proposal’s expansion of authority under Part 340, which creates a redundant weed risk regulatory process. This process currently works under USDA’s Part 360 regulations.
Finally, USDA’s plans for major changes to the current regulatory system may have unintended consequences for other regulatory agencies as well as domestic and international markets and may lead to significant litigation risks, the groups cautioned.
“We are concerned that these flaws will have a significant negative impact on innovation, particularly for small companies and universities hoping to develop agricultural products for specific regional or environmental needs or to develop minor-use crops that could be important domestically and internationally,” they wrote, adding that USDA can better meet its goals with fewer risks and disruptions by charting a different regulatory course.