18/07/2024 | Press release | Distributed by Public on 19/07/2024 03:47
07.18.2024
|
Updates
In a recently published Request for Information (RFI), the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) seeks public comment on options to potentially streamline and reduce the regulatory burden for modified microbes consistent with current APHIS regulations at 7 C.F.R. Part 340 covering the movement of organisms modified or produced through genetic engineering. The agency is currently accepting comments until September 3, 2024.
How the U.S. Government Regulates Biotechnology
The federal government regulates biotechnology products under the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). First established in 1986, with updates in 1992 and 2017, the Coordinated Framework outlines a comprehensive federal regulatory policy for oversight of biotechnology products under existing federal statutes implemented by the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and USDA. The Coordinated Framework describes the roles and responsibilities of each agency based upon a product's particular use and sets out key principles for regulatory oversight, with the overarching goal of facilitating the protection of public health and the environment while simultaneously promoting innovation.
Turning to USDA, in particular, APHIS administers the Animal Health Protection Act (AHPA) and the Plant Protection Act (PPA). Through these federal statutes and their implementing regulations, USDA regulates products of biotechnology that may pose a risk to agricultural plant and animal health. Additionally, pursuant to the Virus-Serum-Toxin Act (VSTA), USDA regulates products of biotechnology that are included in veterinary biologics and aims to ensure that veterinary biologics are pure, safe, potent, and effective.
Recent Developments
In December 2022, the Office of Science and Technology Policy (OSTP) issued a notice of request for information on the regulation of biotechnology on behalf of USDA, FDA, and EPA. The December 2022 RFI sought to identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework with a particular emphasis on new and emerging biotechnology products. APHIS's July 2024 RFI stems from responses to the December 2022 OSTP RFI. In particular, in response to the OSTP RFI, multiple commenters expressed a need for clear regulatory pathways to commercialization for modified microbes. As such, APHIS is now requesting stakeholder comments regarding pathways to commercialization, including needs, ideas, and concerns, regarding possible APHIS risk-based deregulation of modified microbes and other potential regulatory and nonregulatory pathways to commercialization.
USDA's July 2024 RFI
APHIS explains that the requested information will help the agency to identify potential criteria and mechanisms for risk-based deregulation, develop a regulatory framework that could inform future rulemaking, and identify potentially viable nonregulatory solutions for APHIS Biotechnology Regulatory Services to improve coordination with APHIS's Plant Protection and Quarantine and the EPA.
APHIS specifically asks for feedback on the following six questions:
This RFI provides developers and other interested stakeholders an opportunity to help shape a clearer and more streamlined regulatory pathway for modified microbes-an essential component to further promoting innovation in agricultural industries and beyond.
All comments should be received by APHIS on or before September 3, 2024.
Perkins Coie's Food & Beverage team includes a former USDA regulatory lawyer. We regularly interface with APHIS and provide strategic advice for navigating new and emerging rules and policies at APHIS and related agencies. If you have any questions concerning the material discussed in this Update, please contact the authors.
© 2024 Perkins Coie LLP