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On May 15, 2026, the U.S. Department of Agriculture (USDA) published a Request for Information (RFI) seeking public input on the future regulation of genetically engineered (GE) organisms under the Plant Protection Act (PPA). The RFI follows the December 2024 decision by the U.S. District Court for the Northern District of California vacating USDA’s 2020 SECURE rule, which had modernized the USDA Animal and Plant Health Inspection Service’s (APHIS) biotechnology regulations and shifted oversight toward a more product- and risk-based framework.
As discussed in our prior alert regarding USDA’s reversion to the pre-2020 framework, the court’s ruling restored the earlier regulatory regime under 7 C.F.R. Part 340, under which GE organisms are regulated largely based on whether a plant pest was used during development. In the new RFI, USDA signals continued interest in a more risk-proportionate regulatory approach and asks stakeholders whether APHIS should continue distinguishing between conventional and GE organisms in its regulations.
The RFI also reflects broader uncertainty within USDA regarding how emerging agricultural technologies – including microbial products, biological inputs, and biotechnology-enabled products – fit within existing regulatory authorities. USDA specifically requests comment on whether modified organisms could instead be regulated under 7 C.F.R. Part 330, which governs conventional plant pests and related biological organisms more generally, and seeks feedback on field trial oversight, commercialization barriers, trade implications, and impacts on smaller developers.
These questions arise at a time of increasing regulatory attention to agricultural biological products and plant biostimulants. As discussed in our recent update on plant biostimulant regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), regulators and industry continue to grapple with how existing statutory frameworks apply to biological and biotechnology-derived agricultural products that do not fit neatly within traditional pesticide or biotechnology paradigms.
In particular, APHIS and USDA Plant Protection and Quarantine (PPQ) officials have increasingly acknowledged the absence of a harmonized regulatory pathway for microbial and biotechnology-related products and have suggested that future oversight may move toward a more evidence-based assessment of plant pest risk rather than a presumption of risk. At the same time, stakeholders continue to report uncertainty regarding PPQ jurisdictional triggers, data expectations, and review timelines for certain microbial and biological products.
The RFI also coincides with renewed congressional attention to plant biostimulants in the pending Farm Bill. As currently drafted, the legislation would establish a federal definition of “plant biostimulant” and clarify that qualifying products are not regulated as plant regulators under FIFRA. Although directed principally at EPA regulation, that statutory definition could influence USDA’s future approach by reinforcing distinctions between products intended to support natural plant processes and products subject to more stringent oversight as pesticides under FIFRA. Depending on how USDA ultimately revises its biotechnology regulations, the Farm Bill definition may become increasingly relevant for companies developing microbial or biologically derived agricultural products that exist at the intersection of USDA and EPA jurisdiction.
Taken together, USDA’s RFI, ongoing APHIS discussions regarding plant pest authorities, and congressional efforts to define plant biostimulants suggest that federal regulation of agricultural biologicals may be entering a broader period of transition. Companies operating in these sectors should closely monitor these developments, particularly where products may involve microbial components, biotechnology-derived traits, or novel mechanisms of action that could trigger overlapping USDA and EPA review considerations.
Comments on the RFI are due June 15, 2026.
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