Clearing a Path To Market for Genetically Engineered Microbes
Gaps in U.S. Regulation of Genetically Engineered Microbes and How the Agencies Can Fill Them
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Genetically engineered microbes need a pathway to market. Fertilizer runoff and nitrous oxide emissions remain massive issues for agricultural climate and environmental impacts, and damage from disease, drought, and high heat events are increasing with climate change. More companies are developing genetically engineered microbes to address these challenges, but without a clear way for developers to get their products approved for commercialization, beneficial products will be delayed for years, or never get out of the lab. Therefore, regulation of modified microbes must support commercialization and realization of benefits while minimizing potential risks.
In 2020, when USDA finalized new and improved regulations for genetically engineered organisms, the new exemptions for low-risk products and the new application review process applied only to plants, not microbes. Over the past several years, a Request for Information (RFI) from the Office of Science and Technology Policy and an executive order have directed agencies to modernize the regulatory system for genetically engineered organisms, and commenters have called for a clear path to market for genetically engineered microbes.
USDA has made progress by publishing a series of draft guides for submitting permit applications for genetically engineered microbes, but these do not add any exemptions or change the regulatory process significantly, though they may make it easier for developers to understand the permit system and save time in applying for one. The new guidance does not address product developers’ calls for up-front exemptions for low-risk products, or the ability for genetically engineered microbes to go through the existing processes for confirmation of exemption and RSR that are currently reserved for plants. Without a clear path to market, developers lack much-needed clarity for themselves and their investors, and without any exemptions for low-risk products regulatory agencies expend more resources than necessary to effectively minimize the risks of new products.
In July 2024, USDA issued an RFI on “Exploring Pathways to Commercialization for Modified Microbes.” The Breakthrough Institute submitted comments in response to the RFI, which are posted below and can also be found here. Our comments and others discuss these remaining gaps in US regulation of genetically engineered microbes and how the agencies can fill them to create a clear path to market for these potentially beneficial products.
Regulators of genetically engineered microbes for crop fertilization and disease control are not starting from scratch. There have been treatments for seeds and soil that include naturally-occurring microbes for much longer than agricultural genetically engineered microbes have existed. Products with these naturally-occurring microbes can benefit crops by improving disease resistance, resilience to drought, nitrogen fixation, and absorption of nutrients from the soil. The regulatory path for non-genetically engineered microbial treatments is clear, and has functioned for many years. The USDA agency APHIS PPQ regulates plant pests and organisms used to control plant pests, but as long as all the microbes in the treatment are known and none of them are plant pests, then the developer doesn’t need to apply for permits for transit and use of the product, which makes commercialization possible. In comparison, there is currently no clear pathway out of permit requirements for genetically engineered microbes.
You may be wondering: if non-engineered microbes can improve agricultural production, then why do we need engineered microbes? A great example is Pivot Bio’s engineered microbial fertilizer product. The non-engineered microbe can help with nitrogen fixation, but only when nitrogen is scarce, so scientists used gene editing to turn on the nitrogen fixation even when nitrogen is present at higher levels in the soil. Since agricultural soils have high enough amounts of nitrogen to stop the non-engineered microbes from fixing nitrogen, the engineered microbes are necessary to provide more nitrogen to crop plants even in the presence of fertilizer.
In addition to getting genetically engineered microbes to farmers, a clear regulatory path is necessary to support the participation of small and medium sized developers and academic institutions in research and development, which will diversify the array of products available as they may pursue different types of products than large companies.
Pivot Bio was founded in 2011 and is still very small compared to many older companies that make genetically engineered products and agricultural inputs. The company’s first product got to market after going through a regulatory path at USDA that no longer exists, and was partially replaced in the newer regulations for plants but does not apply to microbes. This pathway gave Pivot Bio a clearer path to market than today’s regulations. The company received a response from the agency saying the product is not subject to regulations for genetically engineered organisms under USDA because it does not pose a plant pest risk. Pivot Bio’s publications with partner universities show large benefits from their products, while some independent studies don’t bear out the same benefits.
Not only do modified microbes need a clear pathway to market, but the US regulatory system must improve its ability to develop regulations for new types of products in a timely manner. CRISPR gene editing was discovered in 2012, yet USDA did not publish updated regulations for genetically engineered crops that included clarity on gene edited crops specifically until 2020. In fact, other methods of gene editing including TALENs and ZFNs have been used in plants for even longer, and the first gene-edited food released to consumers in the US in 2019—soybean oil with more oleic acid and less saturated fatty acids—was made using TALENs. In comparison to the US’ 2020 advancement in regulations, Argentina finalized regulations for gene edited crops in 2014, setting the standard for other countries’ regulatory systems.
Though US federal regulatory agencies have made some progress toward regulations for genetically engineered microbes in agriculture, there is still no clear pathway to market for these products. The negative environmental impacts of fertilizer runoff and diseases that reduce crop productivity are significant issues for US agriculture, and we need all possible tools to address these challenges. Regulators must act quickly to enable greater use of this technology to support agricultural productivity growth and reduce the environmental impacts of food production.