Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

After overhauling its biotechnology regulations for plants developed using genetic engineering, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its regulatory procedures, both by opening the door to major regulatory changes for microbes developed through genetic engineering and by surveying the results of its previous changes for plant regulation.

In July, APHIS requested public comment regarding modified microbe regulation and released a biotechnology regulation enforcement summary. Comments are due September 3, 2024. In June, APHIS released its biotechnology regulation impact report for 2023. These announcements, which highlight the morphing U.S. regulatory landscape for genetically engineered plants and microbes, are described in detail below.

Invitation for Public Comment on Modified Microbe Regulation

On July 2, 2024, APHIS announced the opening of a 60-day public comment period on a Request for Information (RFI) that explores options to reduce the regulatory burden for modified microbes (available now in the Federal Register). APHIS requests comments from the public regarding pathways to commercialization, including needs, ideas, and concerns, regarding possible risk-based deregulation of modified microbes and other potential regulatory and non-regulatory pathways to commercialization. More specifically, APHIS asks for comments on the following topics:

1. Expertise and resources needed in the government to evaluate plant pest risk of modified microbes
2. Areas for improvement in the clarity and/or efficiency of regulations governing modified microorganisms
3. Technical considerations that would enable a scientifically sound regulatory assessment of a modified microorganism’s plant pest risk
4. How modified microorganisms with multiple uses should be regulated and evaluated by APHIS, and steps should APHIS take to ensure efficient and appropriate oversight and evaluation when a product is subject to regulation and review by both USDA and another Federal agency
5. Whether APHIS should consider risk-based exemptions for certain types of microorganisms or for certain modifications in microorganisms
6. Any other issues the public thinks APHIS should consider in developing a regulatory framework for assessing the plant pest risk of modified microorganisms or pathways to commercialization for modified microorganisms

Comments should be received on or before September 3, 2024, and can be submitted either electronically through the Federal eRulemaking Portal (Docket No.: APHIS-2024-0002) or mailed in (send your comment to Docket No. APHIS-2024-0002, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238).

Previously, on March 23, 2023, APHIS had made available for review a draft Guide for Submitting Permit Applications for Microorganisms Developed using Genetic Engineering Under 7 CFR part 340 on its website and opened a comment period. Commenters expressed concern regarding the lack of processes for modified microbes, particularly when compared to those for modified plants, such as the express exemptions at § 340.1 and the Regulatory Status Review process. These comments may explain the APHIS’s focus on acquiring more information on how the public views potential pathways and express deregulation for some categories of modified microbes.

APHIS BRS Investigations

Separately, on July 9, 2024, APHIS released its Enforcement Services Annual Enforcement Data Report overviewing how it enforced its regulations in the 2023 fiscal year. For example, the Report summarized enforcement data regarding regulatory correspondence to parties involved in an alleged violation, charging a stipulated penalty, and referring the case to the USDA or U.S. Department of Justice for further action.

Among this data, APHIS included a section on enforcement relating to its Biotechnology Regulatory Services (BRS), which included initiation of one case by APHIS’s Investigative and Enforcement Services (IES). The report stated that the case was resolved in the 2024 fiscal year through a pre-litigation settlement that resulted in the collection of $16,240 in stipulated penalties. This summary is notable as it is one of the first published reports of enforcement and associated penalties from the revised biotechnology regulations for plants produced through genetic engineering.

APHIS Releases 2023 Impact Report – Safe Biotechnology Products

In June, APHIS issued its 2023 Impact Report noting its accomplishments last year. One of the areas of focus was on safe biotechnology products, through which APHIS promoted crops that help achieve climate goals and are healthier to eat, while ensuring that these products are safe to eat and grow.

The full report can be found on the USDA website, but some notable achievements include:

• Issued 15 Regulatory Status Review (RSR) decisions to developers.
• Reduced RSR processing times and completed roughly three times the number of product reviews compared to the legacy review process.
• Responded quickly to 40 requests for confirmation that a plant met the criteria for exemption from regulation, of which 86% replicated modifications achievable through conventional breeding and 95% were developed by small- to medium-sized enterprises and public institutions.
• Issued 784 authorizations for the movement or field testing of organisms developed using genetic engineering.
• Performed more than 700 inspections with State agricultural officials of authorized field trials involving organisms developed using genetic engineering.
• Delivered more than 10 presentations to international stakeholders to offer technical information and build capacity abroad for regulating biotechnology.
• Contributed to the critical international guide for the products of biotechnology, which was finalized after more than 15 years of development.

The activities described in the report represent robust use of APHIS’s revised regulations for engineered plants. The report also shows that the agency is gaining momentum and becoming increasingly nimble at administering its now four-year-old revised regulations.

Many if not all of these topics and more will likely be discussed live with the public at APHIS’s annual stakeholder meeting, which is scheduled for November 14, 2024, and the agency is soliciting topics for discussion by email.

For additional information on U.S. regulations on genetic engineering, see our other posts:

• New Plants, Old Frameworks: FDA’s 1992 Policy Applies to Foods Derived from Genome-Edited Plants
• Comment on Morphing U.S. Biotechnology Regulations
• New Regulations Rooted In Evidence: Looking Back On How EPA and USDA Updated Engineered Plant Regulations and Labeling In 2023

Marley Macarewich, a summer associate in Morrison Foerster’s San Francisco office, contributed significantly to this post.