October 28, 2021

Volume XI, Number 301

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APHIS Announces Draft Regulatory Status Review Guide Available for Public Comment

On August 25, 2021, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its release of a draft guide detailing the information requirements and process for submitting a Regulatory Status Review (RSR) request. Developers of certain genetically modified organisms may use the RSR process to determine the regulatory status of the organisms. The draft guide is open for public comment for 60 days. APHIS also will host a webinar to provide an overview of the draft RSR guide.

On May 18, 2020, APHIS published revised biotechnology regulations, codified in 7 C.F.R. Part 340 and referred to as the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. For a discussion of the SECURE rule, please review Final SECURE Rule Will Update and Modernize USDA's Biotechnology Regulations. The revised regulations identify high-level information requirements for submissions to support RSR requests. In response to comments on the proposed SECURE rule, APHIS stated that it would publish detailed information requirements as a draft guide for public comment prior to issuing the draft guide in final.

The draft RSR guide is available on the APHIS website, at the bottom of the tab labeled The Regulatory Status Review Process, and also in the online docket. The public may submit comments here. APHIS states that it will consider all comments received by October 25, 2021, prior to issuing the final RSR guide. Additionally, APHIS will host a technical webinar on September 21, 2021, to discuss the RSR process and guide, and provide stakeholders the opportunity to ask questions. Registration is available now on the APHIS website.

Commentary

APHIS is authorized by the Plant Protection Act to evaluate potential plant pest risks resulting from certain organisms developed using genetic engineering techniques. Prior to the SECURE rule, developers of genetically modified plants could petition APHIS to seek a determination that a modified plant is unlikely to pose a plant pest risk and therefore is no longer subject to APHIS’ biotechnology regulations. With the SECURE rule, APHIS made several changes to its procedures, including introduction of the RSR process. The RSR process was implemented for select crops on April 5, 2021, and will be fully implemented for all crops on October 1, 2021.

Developers must submit a significant amount of technical information to APHIS to support a determination that a genetically modified plant can be deregulated. It typically is welcome news when regulators clarify the information that they need to make a regulatory determination, particularly given the time and resources invested in a new technology. A clear regulatory process, including information requirements and review timelines, allows industry to plan accordingly. The APHIS draft guide addresses information requirements, the review process, decision timelines, confidential business information justifications, and key definitions, and provides an optional submission template. It appears to be a useful tool in planning an RSR submission. We urge developers of genetically modified plants to review the guide carefully. If, following review, there are issues that require additional clarification, developers should highlight those issues in comments submitted to the docket linked above.

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 243
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About this Author

Sheryl Dolan, Senior Regulatory Consultant, Toxic Substance Control Act, Nanoscale Chemicals, Bergeson and Campbell Law Firm
Senior Regulatory Consultant

Sheryl Dolan is an excellent asset to clients who have issues in chemical regulation, registration, and compliance management matters. She works with manufacturers of conventional and nanoscale chemicals, and industrial and consumer products, including intergeneric microorganisms, for compliance with requirements under the Toxic Substances Control Act (TSCA). She also works with registrants of agricultural and other conventional pesticides, antimicrobial products, biopesticides, and plant regulators to register and manage compliance with requirements under the Federal...

202-557-3804
Barbara Christianson, Bergeson & Campbell, P.C., Paralegal
Paralegal

Barbara Christianson has worked at Bergeson & Campbell, P.C. (B&C®) for over a decade, honing her experience in the industries that Bergeson & Campbell serves. As a paralegal, Ms. Christianson supports Bergeson & Campbell's professional staff with a broad range of detail-oriented, oftentimes deadline-driven activities.

Ms. Christianson plays a key role in coordinating and providing detailed quality control review of documents and submissions and has significant experience using industry-specific software programs. She...

202-557-3807
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