Global Shifts in Plant Biotech Regulations

2026 may well be remembered as the year global agriculture began to untangle itself from decades of precautionary red tape. Earlier this year, the agricultural biotechnology landscape shifted in two places that have long defined opposite poles of the regulatory debate: the European Union, historically the home of exceedingly precautionary biotech rules, and the United States, a pro-innovation leader now eyeing a massive regulatory overhaul.

The EU Parliament recently approved a landmark framework for regulating New Genomic Techniques (NGTs). Many plants developed with CRISPR or other precise gene editing techniques will now be treated more like conventional crops by regulators than transgenics commonly referred to as “GMOs”. Meanwhile, the US Department of Agriculture (USDA) is weighing a clean break from its legacy Part 340 biotechnology rules, which have been in place since the late 1980s.

Together, these moves mark a broader retreat from process-based regulation toward more risk-based and technology-agnostic frameworks. Product-based regulations ask what a product does, what risks it plausibly poses, and whether regulation will actually improve safety rather than focusing on the technology used in the development process.

Modernizing these legacy regulatory processes is about more than administrative streamlining; it's the key to ushering in a new wave of agricultural innovation. Consumers stand to gain access to products like seedless blackberries, pitless cherries, non-browning bananas, naturally decaffeinated coffee beans, and apples that don’t need to be sprayed with insecticides.

While the EU’s NGT reforms and the US’ potential overhaul are steps in the right direction, true modernization demands all genetically engineered products—including gene-edited and transgenics—be treated the same as conventionally bred crops. Continuing to differentiate between these categories as a proxy for risk conflicts with the scientific consensus that gene-edited and transgenic crops don’t pose new risks compared to those developed with conventional breeding methods, often making changes to a plant’s DNA with greater speed and accuracy and fewer unintended changes. Only by aligning regulations with established science will we be able to unlock the benefits of biotechnology innovation in agriculture.

The EU’s shift: Embracing new genomic techniques

After several years of scientific review, public debate, and legislative negotiation, the European Parliament and Council officially cleared a new NGT framework for launch. The new legislation establishes a two-tiered pathway system for regulating gene-edited crops. Plants with minor modifications that could have occurred naturally or through conventional breeding will qualify as Category 1 NGTs and be exempt from full GMO risk assessments. More complex gene-edited crops remain subject to stricter authorization pathways as Category 2 NGTs. Those specifically engineered for herbicide tolerance or insecticidal properties are automatically considered Category 2 NGTs.

The new rules will officially kick in mid-2028. For companies with gene-edited varieties already in the pipeline, like Inari Agriculture’s high yielding soybeans, their products could be commercialized in the EU soon after. A second wave of products can be expected over the next decade as new investments in seed companies targeting the EU market are spurred by this shift in the regulatory environment.

Agricultural innovators are celebrating the EU decision as a victory for food security and cross-border trade predictability. The EU’s legacy regulations have contributed to a growing yield and input optimization gap between European farmers and farmers in countries, like the US, that have allowed for the cultivation of genetically modified plants. While US farmers adopted genetically modified traits that reduce losses from insects and weeds, thereby helping increase yields, EU farmers remain tethered to conventional breeding lines.

Existing genetically modified traits for insect resistance and herbicide tolerance have increased yields by 22% across industrialized and developing countries. EU farmers have been locked out of these benefits with only one type of GM corn—the insect-resistant MON810—approved to be grown only in Spain and Portugal. GM traits have been further shown to raise farm incomes by an average $103 per hectare in 2020 for widely grown crops. Farmers in developed countries experience an average $3 increase in income for each additional dollar they spend on genetically modified seeds, above the cost of conventional seeds. The Breakthrough Institute estimated that maintaining legacy precautionary rules for NGTs would have cost the EU €171 billion to €335 billion annually, compounding to over €3 trillion in foregone benefits over a decade.

The EU’s new policy will enable the bloc’s farmers to benefit from some gene-edited crops. But it still does not align regulation with the actual risk different crops could pose. Transgenic crops remain subject to the EU’s highly restrictive GMO regime, despite decades of safe use on hundreds of millions of acres worldwide. Likewise, many more complex gene-edited crops will continue to undergo full GMO-style risk assessments as Category 2 NGTs. While the new legislation provides incentives for faster review of Category 2 NGTs that improve yields or otherwise advance sustainability, it excludes crops specifically engineered for herbicide tolerance or insecticidal properties from any expedited process. This will likely restrict farmers’ access to herbicide-tolerant crops and limit their adoption of conservation tillage practices that such traits have helped enable in the US. Furthermore, should a transgenic or Category 2 NGT crop ultimately garner EU market authorization, EU Member states will still maintain the ability to ban cultivation in their territories.

The United States at a crossroads: moving beyond Part 340

While the EU's new policy brings its standards somewhat closer to the US regulatory regime, the US is already preparing its next competitive leap forward.

The White House established the Coordinated Framework for the Regulation of Biotechnology in 1986 guiding federal regulatory policy in an attempt to protect human health and the environment without impeding innovation. Soon after, USDA enacted a rule at 7 CFR Part 340, anchoring the agency’s oversight of biotechnology to its authority to regulate plant pest risk.

After more than a decade of attempts to modernize Part 340, USDA’s latest revision, the SECURE rule, was vacated in 2024 after a lawsuit brought by a coalition of environmental groups. Since then, USDA has reverted to using its legacy framework for regulating products of biotechnology, including modified crops and microbes.

As indicated in a recent Request for Information put to the public, USDA is now exploring a clean break from the decades-old Part 340 regulations in favor of an overhaul. In doing so, USDA has an opportunity to usher in a product- and risk-based system that no longer differentiates between modified and conventional products. Congress has never directed USDA to regulate genetically engineered crops differently or to a greater degree than others (except to label genetically engineered food). Regulating them in the same way as conventional crops and only restricting organisms that are considered a "plant pest" or "noxious weed" would better align with the statutory intent set by Congress in the Plant Protection Act and with White House policy to “avoid arbitrary or unjustifiable distinctions across like products developed through different technologies” and to "make regulatory determinations based on risks associated with the product and its intended end use.”

The agency should be careful not to simply replicate past reform attempts or substitute one process-based regulatory trigger for another. To put in place a new regulatory system that aligns the agency’s oversight with its statutory authority to regulate plant-pest risk, USDA must: 1) establish a clear, predictable "red flag" list of criteria that trigger premarket review regardless of breeding technology used; 2) institutionalize a voluntary confirmation of exemption process for low-risk traits to protect developers' export certainty; and 3) create clear paths to commercialization for modified microbes, which have languished without a consistent path to commercialization over the last decade.

Additionally, USDA should consider the staffing capacity and expertise required to successfully develop and implement a new regulatory framework. Making significant changes to the regulatory regime will require more than administrative reorganization; it necessitates a concerted effort to retain the specialized Biotechnology Regulatory Services (BRS) staff who possess deep technical and institutional knowledge. Even regulatory streamlining efforts require significant upfront investment to be effective. For example, USDA previously sought a $9 million funding increase to support the implementation of the SECURE rule and its changes to Part 340, including resources to manage a unified regulatory website, enhance the IT infrastructure necessary to provide coordinated responses to developers, and dedicate staff to ensuring the regulatory program kept ahead of the pace of innovation. Despite the promise of annual cost savings through modernization, the agency still required consistent discretionary funding to transition systems and manage existing application reviews.

Any shift away from Part 340-centered regulation risks diluting the specialized expertise needed to ensure both scientific integrity and regulatory efficiency in an increasingly complex biotechnological landscape. Therefore, the White House, USDA, and Congress need to prioritize adequate staffing and resources for the agency to maintain oversight without creating a bottleneck in the review pipeline when proceeding with a regulatory overhaul.

Who benefits from reform

These regulatory changes will hopefully drive crop gene-editing to the same extent that 20th-century conventional methods, like double haploid breeding, mutation breeding, and protoplast fusion, improved today's varieties. Today, grocery shoppers in America and Europe regularly buy produce and other foods with ingredients improved by these older laboratory methods without realizing they are consuming the products of advanced genetic manipulation.

In many cases, conventional breeding introduces more genetic uncertainty than genetic engineering. The National Biotechnology Policy Board concluded as early as 1992 that biotechnology processes tend to reduce risks due to better precision. Conventional breeding causes unintended genetic changes similar to the insertional effects observed in transgenic genetic engineering. Selective breeding, mutagenesis, and wide-cross hybridization are more likely to result in off-target changes than gene-editing. Conventional breeding also often results in plants that are more vulnerable to plant pests and lower-yielding than genetically engineered varieties, thus requiring more farmland and thus plausibly expanding the range of agricultural pests.

Streamlining regulatory pathways can benefit crop development companies and researchers focused on the genetic improvement of specialty crops. The bulk of the investment in plant genetics to date has been focused on staple commodities, like corn and soy. Bringing a new trait to market in multiple countries can be costly. Therefore, companies look to invest in widely grown crops so that once commercialized, a product can be adopted on enough acres for the company to recoup its development costs. Based on data from 2017 to 2022 from the four largest biotech companies, the average cost of developing and authorizing a new plant biotech trait was $115 million, with 29% devoted to regulatory science and 9% to registration and regulatory affairs.

Moving past legacy Part 340 regulations in the US could alleviate disproportionate burdens on smaller entities developing regulated plants or microorganisms, particularly transgenic plants. The long review timelines and extensive data submission requirements for transgenics subject to the current Part 340 Petition process effectively screen out small and mid-size developers. From 2015 to 2020 and in 2025, approximately 77% of Petition submissions for transgenic products came from large companies. Streamlining review pathways would lower the barrier to entry for small businesses, universities, and non-profit developers pursuing improvements to the specialty and regional crops that larger commercial developers have little incentive to prioritize.

Regulatory divergence has heavily impacted where biotech companies focus their R&D. Developers of gene-edited plants have long had a faster and cheaper path to market under the US regulatory framework than in Europe. Following a 2018 European Court of Justice ruling that gene-edited crops must be regulated as GMOs, over a third of companies working on NGT research scaled back or halted their NGT-related R&D programs, and the largest companies redirected their product pipelines to more favorable markets. The EU's new regulatory framework provides an opening for those companies to reinvest in NGT development in Europe. Companies that have built out gene-editing pipelines under the US framework stand to be early movers in the EU market as its new rules go into effect, expanding the addressable acreage and consumer base for products that may already be approaching commercialization.

Beyond benefits to biotech developers themselves, modified plants and microbes can bolster dual productivity and environmental benefits. Modifications that boost yields foster land-sparing effects that mitigate global deforestation. Accelerating biotechnology approvals for pest- and disease-resistant traits will enable farmers to reduce the volume and toxicity of chemical crop protection applications and help minimize losses in the face of emerging threats. Gene-edited microbes can also enhance agricultural sustainability. For example, nitrogen-fixing microbes can curtail greenhouse gas emissions generated during synthetic fertilizer manufacturing and application.

The importance of implementation

The EU is taking a major step toward unlocking unrealized gains under its historically restrictive policies for genetically modified plants. Its successful implementation of the NGT framework could lay the groundwork for an even more permissive regulatory environment in the future.

Meanwhile, it is crucial that the US move forward with a regulatory overhaul to evaluate modified organisms no differently than conventional products. To do so, USDA must put forward new rulemaking to move away from Part 340 and to regulate biotechnology under existing regulations, like Part 330, that apply to all organisms. Further, Congress should pass new legislation to address remaining non-regulatory barriers to scale and provide oversight as the current administration endeavors to establish such a risk-based framework. Establishing congressional intent will provide added certainty that regulatory changes will endure across future administrations.

These recent actions made by the EU and under consideration in the US demonstrate a growing global consensus that agricultural success amidst growing food demand and mounting production challenges will require leaving the precautionary principle behind.