USDA Seeks Comments on a Future Regulatory Framework for Modified Organisms

On May 15, 2026, the U.S. Department of Agriculture (USDA) published a Request for Information (RFI) to solicit input on regulatory considerations related to the review of modified organisms subject to the Plant Protection Act (PPA).

Background

The PPA authorizes USDA to regulate the movement of plant pests.  USDA has delegated implementation of this regulatory authority to the Animal and Plant Health Inspection Service (APHIS), with 7 CFR § 340 (Part 340) governing the regulation of certain genetically engineered (GE) organisms that are characterized as “regulated articles” based on a plant pest risk assessment, and 7 CFR § 330 (Part 330) governing the movement of plant pests, biological control organisms, and associated articles.

This RFI follows a series of significant changes to the regulatory framework for modified organisms that began at the end of 2024. On December 2, 2024, the U.S. District Court for the Northern District of California vacated APHIS’s 2020 SECURE rule. The SECURE rule had revised Part 340 to exempt many GE organisms from USDA regulation and had streamlined the deregulation process as part of a more risk-based framework. Following the vacatur of the 2020 rule, USDA announced it was restoring the pre-2020 framework, which includes “Am I Regulated” (AIR) inquiries, a permitting process for regulated articles, and petitions for nonregulated status. APHIS has also indicated that it will no longer conduct environmental analyses under the National Environmental Policy Act (NEPA) for deregulation petitions.

USDA’s Questions

In the wake of these changes, the RFI indicates that USDA is reassessing the current regulatory framework and considering potential pathways for risk-based deregulation to inform future rulemaking. The RFI seeks public comments on eight questions:

1. Risk differentiation: APHIS distinguishes between conventional organisms and GE organisms in its PPA regulations.  Are there material differences in plant pest risk between conventional and GE organisms, and if so, on what basis?
2. SECURE rule experience: Under the 2020 rule, what worked well and what could have been improved?  What obstacles existed for field trials and commercialization, and what were the costs associated with compliance and navigation of the regulatory requirements?
3. Current Part 340 experience: Same questions as above for the SECURE rule, but specific to the reinstated pre-2020 framework.
4. Part 330 as an alternative: Could APHIS effectively regulate modified organisms under Part 330 instead of Part 340?  What should APHIS consider for this possible replacement in regulation (e.g., trade implications)?
5. Benefits and challenges of Part 330: What changes to Part 330 would be needed for effective regulation?
6. Key elements for assessing plant pest risk: What should the ideal regulatory framework look like to enable a scientifically sound assessment of a modified organism’s plant pest risk?
7. Burden on small entities: Did the SECURE rule and/or does the current Part 340 framework impose disproportionate burdens on smaller developers?
8. Other issues: Any other issues or topics APHIS should consider for developing a regulatory framework to assess plant pest risk or commercialization pathways for modified organisms.

Looking Ahead

This RFI presents an opportunity for stakeholders to weigh in on the future direction of USDA’s regulatory oversight for modified organisms. The eight questions signal possible interest from USDA in a revised regulatory approach and even “non-regulatory” solutions, considering, for example, a discontinuation of the distinction between conventional and GE organisms, and replacing regulation under Part 340 with the more general Part 330. These changes could significantly reshape the relevant regulatory pathways for certain modified organisms, particularly for developers of CRISPR-edited plants and other new biotechnology products that have faced uncertain or redundant regulatory oversight.

The RFI comment period is currently open through June 15, 2026. MoFo frequently assists our clients with preparing comments for submission to USDA and is happy to assist with developing comments for this RFI.

MoFo’s team includes a former USDA regulatory lawyer and a team of attorneys with extensive experience advising on agricultural biotechnology, novel production technologies, and federal regulatory strategy, and is well positioned to assist stakeholders in evaluating the RFI and developing comments or broader engagement strategies.

If you have any questions concerning the developments discussed in this client alert, please contact the authors.