USDA RFI Seeks Input On Regulatory Considerations Related To The Review Of Modified Organisms Subject To The Plant Protection Act

The U.S. Department of Agriculture (USDA) published a Request for Information (RFI) on May 15, 2026, to solicit input on regulatory considerations related to the review of modified organisms subject to the Plant Protection Act (PPA). 91 Fed. Reg. 27868. According to the notice, USDA’s Animal and Plant Health Inspection Service (APHIS) wishes to explore alternative frameworks to regulate genetically engineered (GE) organisms under the plant pest provisions of the PPA, “to ensure that regulation and oversight are proportionate to risk, that biotechnology developers in the United States have a predictable regulatory pathway to commercialization and, importantly, to ensure APHIS operates within its statutory authority.” As reported in our May 18, 2020, memorandum, USDA’s 2020 Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule amended the regulations regarding the movement of certain GE organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms. The U.S. District Court for the Northern District of California’s December 2, 2024, ruling prospectively vacated the SECURE rule, and APHIS re-established the regulatory and non-regulatory processes under the pre-May 2020 framework.

According to the May 2026 RFI, APHIS’s experience in evaluating GE plants and microorganisms for plant pest risk “have not revealed a materially different or distinct set of risks associated with GE plants and microorganisms when compared to conventional plants and microorganisms.” The RFI also notes that APHIS’s regulations “do not take clear notice of substantial advances in biotechnology since the late 1980s.” APHIS, therefore, is exploring alternative frameworks to regulate GE organisms under the plant pest provisions of the PPA, “to ensure that regulation and oversight are proportionate to risk, that biotechnology developers in the United States have a predictable regulatory pathway to commercialization and, importantly, to ensure APHIS operates within its statutory authority.”

Based on this background information, APHIS seeks public comments regarding the following questions:

1. Are there material differences in plant pest risk between conventional and GE organisms (plants, microorganisms, or insects)? What is the basis, e.g., science-based studies, if such a difference exists? If not, should APHIS continue to distinguish between conventional and GE organisms in its PPA regulations?
2. Describe your experiences of regulation under the SECURE rule. Were there areas that could have been improved? Were there obstacles to performing field trials? What about obstacles advancing from field trials to commercialization? What were the costs incurred complying with and/or navigating the regulatory requirements of the SECURE rule? What areas of the SECURE rule worked well?
3. Describe your experiences of regulation under the current 7 C.F.R. Part 340. Are there areas that could be improved? Are there obstacles to performing field trials? What about obstacles advancing from field trials to commercialization? What are the costs incurred complying with and/or navigating the regulatory requirements of 7 C.F.R. Part 340?
4. Could APHIS effectively address plant pest risks of modified organisms by regulating them under 7 C.F.R. Part 330 instead of 7 C.F.R. Part 340? What should APHIS consider when determining whether 7 C.F.R. Part 330 could replace regulation of modified organisms under 7 C.F.R. Part 340? For example, what might be the trade implications of a new regulatory framework for modified organisms under the PPA?
5. What would the benefits and challenges be of regulating modified organisms under 7 C.F.R. Part 330? What changes, if any, would need to be made to 7 C.F.R. Part 330 for effective regulation?
6. Describe key elements of a regulatory framework, including oversight of field trials, that would enable a scientifically sound assessment of a modified organism’s plant pest risk.
7. Did the SECURE rule — and does the current 7 C.F.R. Part 340 — impose disproportionate burdens on smaller entities developing regulated plants or microorganisms?
8. Are there any other specific issues or topics APHIS should consider in developing a regulatory framework for assessing the plant pest risk of modified organisms, or possible pathways to commercialization for modified organisms?

According to USDA, the information provided will help identify factors for potential risk-based deregulation and could inform future rulemaking. USDA notes that input might also offer non-regulatory solutions. Responses are due June 15, 2026.

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