On Thursday, USDA, EPA, and FDA jointly released a plan to modernize the U.S. federal regulatory system for products of biotechnology. This long-awaited plan was welcomed by ASA and comes as a positive next step for implementing a 2022 Executive Order from the administration that aims to advance the use of biotechnology and the bioeconomy. Public feedback was used to develop the plan, including comments provided by ASA and other stakeholders.
The regulatory plan is very comprehensive and includes proposed regulatory changes for many applications of biotechnology and genetic improvement technologies, including plant gene editing, animal biotechnology, genetically engineered microbes, biomedical applications, disclosure of bioengineered products, among others. Highlights of the plan of greatest interest to soybean production include:
- Identifying ways to streamline USDA’s Regulatory Status Review (RSR) process. USDA put this process in place to swiftly review plants that did not immediately meet regulatory exemptions; however, most RSRs to date have greatly exceeded the 180-day regulatory deadline established by USDA. ASA appreciates that USDA acknowledged it would be considering advancing a proposal for additional risk- and science-based exemptions from the department’s scope of regulation.
- EPA will be identifying ways to improve the scope and risk-appropriateness of plant incorporated protectants (PIPs)—or plant biological protection mechanisms—that fall under the agency’s scope of regulation. ASA and other stakeholder groups have been critical of a rule EPA finalized in 2023 that included regulatory requirements for gene edited PIPs that EPA acknowledged were “indistinguishable” from conventionally bred PIPs.
- USDA indicated it would clarify what genetically engineered microorganisms are subject to the department’s regulations. ASA and other grower groups are excited about the prospect of microbial seed treatments and other applications that can be used to improve crop yield and protect plant health. However, a lack of regulatory clarity has stymied commercialization of these tools.
ASA will more thoroughly review the plan in the days ahead and plans to engage with the respective regulatory agencies to advance aspects of this plan that will enable better access to genetic innovations for farmers.
