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 microbesdeveloped 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.

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.

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). 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.

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 further information, read our more detailed client alert.

Summer Associate Marley Macarewich also contributed significantly to this post.

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