On March 23, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it had issued a draft guidance document describing information requirements and procedures applicants should follow when submitting permit applications for microorganisms developed using genetic engineering.
USDA’s biotechnology regulations under 7 CFR Part 340, recently updated in 2020, are the rules under which the agency has regulated the interstate movement and environmental release of organisms that may pose a plant pest risk. According to the APHIS website, the 2020 revisions enable the Agency “to regulate organisms developed using genetic engineering for plant pest risk with greater precision and [to] reduce regulatory burden for developers of organisms that are unlikely to pose plant pest risks”. This rule has primarily been used to cover the field testing and outdoor growth of GMO (transgenic) plants, but the regulation also covers certain microorganisms that have been genetically modified and which might pose a risk as a plant pest. Of the 1,540 entries in APHIS’s database of permit applications and notifications it has received under this regulation, 75 are identified as “bacteria” (of various species) and 11 for “fungi” (as well as 66 for “viruses”).
The draft Guide for Submitting Permit Applications for Microorganisms Developed using Genetic Engineering Under 7 CFR part 340 is available for downloading on the APHIS Biotechnology Regulatory Services Guidance webpage. Interested parties may view and submit comments at https://www.regulations.gov/docket/APHIS-2023-0030/document. The Agency will consider all comments submitted through May 22, 2023, after which the Agency will finalize the Guide.
The guidance document consists of introductory sections describing the Part 340 Rule and the organisms it might cover. After describing the process by which permit applications are to be submitted, the Guide describes the specific information needed for applications either for interstate movement or for environmental release (e.g. field testing or other experimentation) of modified microorganisms that might be subject to the rule. In either case, the applicant must submit detailed information on the organism, its taxonomy, how it was constructed, and its genotype and expected phenotype. The guidance for environmental use is more detailed, and asks applicants to provide information on the site of the proposed field test, the planned procedures to confine the organism to the test site, procedures for detection and monitoring of the organism and its possible spread beyond the test site, and procedures for devitalization of the organism at the conclusion of the trial. For both types of permit applications, at least one Standard Operating Procedure must be submitted that describes procedures for how the organism will be contained during movement between sites, and how it would be confined during any field release.
Although oversight over modified agricultural microorganisms has only been a minor application of the Part 340 regulation since its inception, it is important because it could potentially cover the types of microorganisms that are being developed for various agricultural purposes, including potential biostimulants, organisms promoting improved nutrient uptake, plant pest biocontrol agents, and others, at a time when many companies and research labs are indeed exploring uses of microorganisms for such purposes. In addition, certain microbes regulated under this rule could also be subject to review or regulation by the Environmental Protection Agency under the pesticide law FIFRA or the chemical law TSCA.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty-five years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. In addition to his work as a consultant assisting industrial biotechnology companies prepare for and comply with government regulations, he has served as Director of Regulatory Affairs for Joule Unlimited Technologies and Vice President of Government and Regulatory Affairs for BioTechnica International. Dr. Glass has extensive experience with the biotechnology regulations of the U.S. EPA and other agencies, and has coordinated or assisted in the preparation and submission of 18 successful Microbial Commercial Activity Notices and several other biotechnology submissions in the U.S. and other countries. Dr. Glass holds a B.S. in Biological Sciences from Cornell University and a Ph.D. in Biochemical Sciences from Princeton University.
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