USDA’s Biotechnology Regulator Issues Much-Anticipated RFI on Regulation of Modified Microbes

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:

1. Describe new or emerging categories of biotechnology products that are relevant to the development and use of modified microorganisms. To assess new and emerging technologies with modified microbes, what expertise and resources are needed in the government to evaluate the overall plant pest risk of modified microbes?
2. Describe areas where the clarity and/or efficiency of regulations governing modified microorganisms could be improved (e.g., definitions that need to be provided or revised, barriers to obtaining the data necessary to achieve commercialization).
3. Describe key elements of a regulatory framework that would enable a scientifically sound assessment of a modified microorganism’s plant pest risk, in order to inform regulatory decision-making by APHIS.
   1. Describe any biological features of microorganisms that APHIS should consider when determining whether a modification changes the plant pest risk, and thus the regulatory status of a modified microorganism (e.g., the potential for horizontal gene transfer, the production of airborne spores, its ecological role, or the ability to remain dormant for long periods of time).
   2. What criteria, data, and information should be considered when assessing a modified microorganism’s plant pest risk?
   3. What should APHIS consider when determining whether modification of a biocontrol organism could result in it posing a plant pest risk? Provide scientific evidence to support which types of biocontrol organisms and methods could or could not pose a plant pest risk.
4. How should modified microorganisms with multiple uses (e.g., developed for both biomedical or pharmaceutical purposes and agricultural purposes) be regulated and evaluated by APHIS? What 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. Should APHIS consider risk-based exemptions for certain types of microorganisms, or for certain modifications in microorganisms? If so, please provide examples of the types of modified microorganisms that should be exempt from regulation and provide scientific evidence to support which modifications and types of microorganisms should or should not be exempt.
6. Are there any other specific issues or topics APHIS should consider in developing a regulatory framework for assessing the plant pest risk of modified microorganisms, or possible pathways to commercialization for modified microorganisms?

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.