07/15/2024 | News release | Distributed by Public on 07/15/2024 11:04
This RFI presents an important opportunity for engagement by developers of modified microbes intended for agricultural or other uses.[1] Specifically, APHIS is soliciting comments "regarding pathways to commercialization, including needs, ideas, and concerns, regarding possible APHIS risk-based deregulation of modified microbes and other potential regulatory and non-regulatory pathways to commercialization." Through this RFI, APHIS aims "to identify potential criteria and mechanisms for risk-based deregulation, develop a regulatory framework that could inform future rulemaking, and identify potential non-regulatory solutions."
USDA, alongside the US Food and Drug Administration and US Environmental Protection Agency, regulates organisms modified or developed using genetic engineering under the Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework delineates the regulatory roles among the respective expert agencies to encourage innovation and investment in biotechnology, streamline regulatory processes, and avoid duplication, while ensuring safety to human, animal, and environmental health.
APHIS regulates under 7 C.F.R. Part 340 the movement and environmental release of certain organisms, including plants, plant pests, and biological control organisms, that were modified or produced using genetic engineering. USDA comprehensively updated these regulations in May 2020 to establish new criteria for exemption and regulatory processes for deregulation, to "facilitat[e] the development of plants developed using genetic engineering that are unlikely to pose plant pest risks." Those regulatory processes include (1) confirmation of exemption, in which a developer can obtain written confirmation from APHIS that its genetically engineered plant is exempt from regulation under Part 340, and (2) regulatory status review (RSR), in which APHIS determines whether a genetically engineered plant "is unlikely to pose an increased plant pest risk relative to the plant pest risk posed by the respective non-modified or other appropriate comparator(s) and therefore is not subject to the regulation."
However, modified microbes do not presently qualify for either an upfront exemption from regulation or access to the RSR process. Under current Part 340 regulations, developers must obtain a permit for movement of a modified microbe that (1) is a plant pest; (2) has received DNA from a plant pest, and that DNA is either capable of producing an infectious agent that causes plant disease or encodes a compound that is capable of causing plant disease; or (3) is used to control plant pests and could pose a plant pest risk.
The lack of clarity regarding regulation of modified microbes, and the absence of a clear pathway for deregulation and commercialization as is available to genetically engineered plants, has been the subject of significant stakeholder outreach. APHIS is therefore soliciting public comments through this RFI on six questions:
With the publication of this RFI in the Federal Register, the 60-day comment period is open, and members of the public will be able to submit comments until September 3. This RFI presents a unique and important opportunity for stakeholder engagement, and particularly for developers to propose practical, science and risk-based solutions to regulatory obstacles. Fostering clear, predictable, and efficient regulatory pathways for modified microbes is essential to encourage innovation and investment in new agricultural and industrial technologies.
ArentFox Schiff's Agricultural Technology group is closely monitoring this issue and other issues of importance to the AgTech industry. If you have further questions, please reach out to Karen Carr, Rebecca Foreman, or the ArentFox Schiff attorney who handles your matters.