USDA APHIS Asks Public to Comment on GMO Microorganisms

This RFI presents an important opportunity for engagement by developers of engineered microbes intended for agricultural or other uses.(1) Specifically, APHIS requests comments “on pathways to commercialization, including needs, ideas, and concerns regarding possible APHIS risk-based deregulation of engineered microbes and other potential regulatory and nonregulatory pathways to commercialization.” Through this RFI, APHIS seeks to “identify potential criteria and mechanisms for risk-based deregulation, develop a regulatory framework that could inform future rulemaking, and identify potential nonregulatory solutions.”

The USDA, alongside the US Food and Drug Administration and the US Environmental Protection Agency, regulates organisms modified or developed using genetic engineering under the Coordinated Framework for the Regulation of Biotechnology. The Coordinated Framework defines regulatory roles among expert agencies to encourage innovation and investment in biotechnology, streamline regulatory processes, and avoid duplication while ensuring safety for human health, animals, and the environment.

APHIS regulates under 7 CFR Part 340 the movement and release into the environment of certain organisms, including plants, plant pests, and biological control organisms, that have been modified or produced using genetic engineering. USDA comprehensively updated these regulations in May 2020 to establish new exemption criteria and regulatory processes for deregulation to “facilitate the development of genetically engineered plants that are not likely to pose a risk to plant pests.” These regulatory processes include (1) exemption confirmation, in which a developer can obtain written confirmation from APHIS that its genetically modified plant is exempt from regulation under Part 340, and (2) regulatory status review (RSR), in which APHIS determines whether the genetically modified plant “is not likely to pose an increased risk to plant pests as compared to the risk to plant pests posed by an appropriate unmodified or other appropriate comparator and is therefore not subject to regulation.”

However, engineered microbes are not currently eligible for either initial exemption from regulation or access to the RSR process. Under current Part 340 regulations, developers must obtain a permit to move an engineered microbe that (1) is a plant pest; (2) has received DNA from a plant pest and that DNA is 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 a plant pest and may pose a plant pest risk.

The lack of clarity regarding the regulation of engineered microbes and the lack of a clear path for deregulation and commercialization available for genetically engineered crops have been a subject of considerable interest from stakeholders. APHIS is therefore seeking public comment through this RFI on six questions:

1. Describe new or emerging biotechnology product categories that are relevant to the development and use of engineered microorganisms. To assess new and emerging technologies with engineered microorganisms, what expertise and resources are needed within the government to assess the overall plant pest risk of engineered microorganisms?
2. Describe areas where the transparency and/or effectiveness of the regulations governing the use of modified micro-organisms could be improved (e.g.., definitions that need to be introduced or changed, barriers to obtaining the data necessary for commercialization).
3. Describe the key elements of a regulatory framework that will enable scientifically sound assessment of the risks of engineered microorganisms to plant pests to inform APHIS regulatory decisions.
   1. Please describe any biological characteristics of the microorganism that APHIS should consider in determining whether the modification alters the risk of plant pests and therefore the regulatory status of the modified microorganism (e.g., potential for horizontal gene transfer, 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 taken into account when assessing the risk of plant pests resulting from the use of modified microorganisms?
   3. What should APHIS consider when determining whether the modification of a biocontrol organism is likely to cause it to pose a risk to plants? Provide scientific evidence that supports which types of biocontrol organisms and methods may or may not pose a risk to plants.
4. How can modified microorganisms with multiple uses (e.g.(i.e., developed for both biomedical or pharmaceutical and agricultural purposes) be regulated and reviewed by APHIS? What steps should APHIS take to ensure effective 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 waivers for certain types of microorganisms or certain modifications to microorganisms? If so, please provide examples of 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 that APHIS should consider in developing a regulatory framework for assessing the plant pest risks of engineered microorganisms, or possible pathways for commercialization of engineered microorganisms?

Following publication of this RFI in the Federal Register, a 60-day comment period will be open, and members of the public will be able to submit comments through September 3. This RFI presents a unique and important opportunity for stakeholder engagement, and in particular for developers, to propose practical, science-based, risk-based solutions to regulatory hurdles. Supporting clear, predictable, and efficient regulatory pathways for engineered microbes is essential to encouraging innovation and investment in new agricultural and industrial technologies.