Letter
Re: USDA Request for Information on Modified Organisms Subject to the Plant Protection Act [Docket No. USDA–2026–0133]
Dear Mr. Poe,
The Agriculture Biotechnology Alliance (ABA, also referred to here as “the Alliance”) appreciates the opportunity to comment on Docket No. USDA 2026-0133, Request for Information on Modified Organisms Subject to the Plant Protection Act. ABA comprises organizations representing producers, biotechnology developers, plant breeding companies, microbial solution providers and public sector entities that advocate for the use of biotechnology solutions in agriculture.
We welcome the U.S. Department of Agriculture’s (USDA) interest in risk-proportionate deregulation and modernization of the oversight of modified organisms such as genetically engineered plants and microorganisms. We also share the goals specified in Executive Order 13874(1) that direct the Federal government to adopt regulatory approaches for agricultural biotechnology products that are proportionate to the risks that they pose and grounded in science.
Many ABA members directly interface with USDA regulators, while others are downstream beneficiaries of access to biotechnology solutions, rendering this Alliance uniquely suited to comment on the impact of regulations across the entire agricultural supply chain. The United States can only realize the full potential of biological innovation when policy and regulatory frameworks keep pace with the technologies they govern. We believe that the Agency’s continued engagement with ABA will support upcoming decisions on regulatory modernization.
Biotechnology is essential to the future of American agriculture. For farmers facing mounting pressures from evolving pest resistance, tightening economics, and more, access to a full suite of biotechnology tools is critical to farm profitability and viability. Biotechnology provides critical tools to develop products that support American farmers as they feed, fuel and clothe the world. These technologies include innovative plant varieties, crop traits, and microbial biological solutions that can enhance soil health, support nitrogen fixation and improve crop protection. A regulatory framework that is unpredictable or disproportionate to risk undermines access to all of these tools. It delays products that American farmers need, deters the investment that drives innovation and ultimately weakens the competitiveness of American agriculture both domestically and in global markets. ABA supports policies that provide a clear, science-based and predictable path to commercialization for the full range of biotechnology products, while maintaining the rigorous safety standards that protect public health and the environment.
The Alliance urges USDA to approach any potential deregulatory action or rulemaking with the understanding that agricultural biotechnology products have a long history of safe use. We agree with the conclusions of the National Academies of Sciences, Engineering and Medicine (2) (NASEM) and the Animal and Plant Health Inspection Service (APHIS) that genetically engineered (GE) plants do not possess plant pest risks materially different from those of conventional plants, citing USDA research and evaluation across several decades. Plants derived from breeding innovation, such as genome editing, with pest risks that are comparable to those developed through conventional breeding and mutagenesis should not be regulated differently.
Similarly, microorganisms modified through genetic engineering that are comparable in characteristics and risk profile to their wild-type counterparts or to microorganisms that would arise through natural mutation or conventional strain improvement should not face a higher regulatory burden simply because of the method used to achieve that modification. The current level of pre-market regulatory oversight for all GE organisms, including GE microbes, is disproportionate to the presumed risks; additional revisions to the regulatory framework, therefore, would be beneficial.
The presence of plant pest vectors or plant pest sequences alone should not trigger regulatory oversight unless there is credible evidence of plant pest risk. An excessively broad approach that emphasizes process over product is contrary to the goals of the Coordinated Framework for the Regulation of Biotechnology(3) (CF) as it can discourage investment and stifle innovation just as the next generation of biotechnology applications emerges.(4) For example, delays in regulatory determinations on improved seed varieties can limit access, disrupt planting decisions, and stunt grower competitiveness in domestic and global markets. This issue is more pronounced for microbial products due to the absence of clear commercialization pathways at the Animal and Plant Health Inspection Service’s (APHIS) Biotechnology Regulatory Services (BRS) for genetically engineered microorganisms, including the lack of a viable deregulation or nonregulated status petition process that has deterred investment and stalled innovation in biological solutions that could meaningfully benefit American agriculture. Predictability and timeliness in regulatory decision-making are as important to developers and growers as the Agency’s decisions themselves.
An ideal biotechnology framework would possess a clear and well-defined regulatory scope, a tiered, risk-proportionate assessment system for organisms that fall within that scope, and would allow for multiple clear commercialization pathways, such as deregulation and commercialization under permit. It should also take a neutral approach to plants of different genetic structures, such as between polyploids and diploids, unless that is credible evidence of increase plant pest risk. Exempting low-risk organisms from regulatory oversight, for example, would allow USDA to focus its resources on the higher-risk scenarios that demand close evaluation. A fit-for-purpose approach is particularly critical for genetically engineered microorganisms, which currently lack any viable pathway to commercialization or deregulation under Part 340. In a modernized biotechnology framework, the Agency could use its finite resources more efficiently; developers could innovate with greater certainty; and producers could make better planting decisions to stay profitable. Such a framework would also maintain existing avenues of collaboration and communication between USDA and state partners. Keeping states closely informed of regulatory determinations and allowing states, when appropriate, to alleviate resource constraints by conducting oversight of field trials are important for achieving regulatory efficiencies.
Lastly, regulatory approaches in the United States should not disadvantage American producers. Growers operate in global markets and compete with foreign producers who may have access to similar innovations under different regulatory systems. USDA must acknowledge that regulatory frameworks affect the availability of technologies, and therefore the competitiveness of U.S. producers compared to other production areas. Any framework that regulates agricultural biotechnology according to the Plant Protection Act must facilitate trade, support market access, and enable American leadership in agricultural productivity and biological innovation.
The Alliance also urges USDA to prioritize meaningful interagency coordination with the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) as it considers reforms to its regulatory framework for modified organisms. The CF was designed to achieve exactly this kind of coherent, non-duplicative oversight; and APHIS’ reforms should reflect and advance that intent.
The Agriculture Biotechnology Alliance values the Department’s use of Requests For Information and other stakeholder outreach instruments to inform policy development. Transparency around other regulatory criteria, decision-making processes, and timelines help stakeholders understand their obligations and plan accordingly. Ongoing engagement with producers, technology developers and other stakeholders is critical as USDA considers any future policy development or rulemaking related to modified organisms under the Plant Protection Act.
Thank you for the opportunity to provide these comments.
Sincerely,
The Agriculture Biotechnology Alliance
1 Modernizing the Regulatory Framework for Agricultural Biotechnology Products (2019)
2Genetically Engineered Crops: Experiences and Prospects (2016)
3Coordinated Framework for the Regulation of Biotechnology (1986)
4 The CF was established to provide a unified federal approach to biotechnology oversight by relying on the existing
statutory authorities of USDA, EPA, and FDA, rather than creating a new biotechnology-specific statute. From its
inception, the CF was intended to ensure that regulation remained science-based, product-focused, and coordinated
across agencies.
