The year 2026 may mark the beginning of a global shift away from decades of restrictive agricultural biotechnology regulations, according to a new report from the Breakthrough Institute. The European Union recently approved a landmark framework for regulating gene-edited crops that will treat many CRISPR-developed plants more like conventional varieties, while the US Department of Agriculture is considering a major overhaul of biotechnology rules in place since the late 1980s. The report argues these moves signal a broader retreat from process-based regulation toward frameworks focused on actual product risks rather than the technology used to create them.
The EU's new policy establishes a two-tiered system where plants with minor modifications that could have occurred naturally will qualify as Category 1 and be exempt from full GMO risk assessments, with the rules officially launching in mid-2028. The Breakthrough Institute estimated that maintaining legacy precautionary rules would have cost the EU €171 billion to €335 billion annually, compounding to over €3 trillion in foregone benefits over a decade. Existing genetically modified traits for insect resistance and herbicide tolerance have increased yields by 22% across industrialized and developing countries, benefits that EU farmers have been largely locked out of with only one type of GM corn approved for cultivation in Spain and Portugal. GM traits raised farm incomes by an average $103 per hectare in 2020 for widely grown crops, and farmers in developed countries see an average $3 increase in income for each additional dollar spent on genetically modified seeds above the cost of conventional seeds. From 2015 to 2020 and in 2025, approximately 77% of petition submissions for transgenic products in the US came from large companies, reflecting how long review timelines and extensive data requirements screen out smaller developers.
The report finds that modernizing these regulatory processes is "the key to ushering in a new wave of agricultural innovation" that could bring consumers products like seedless blackberries, pitless cherries, non-browning bananas, naturally decaffeinated coffee beans, and apples that don't need insecticide spraying. The authors argue that "true modernization demands all genetically engineered products—including gene-edited and transgenics—be treated the same as conventionally bred crops," noting that continuing to differentiate between these categories conflicts with scientific consensus that gene-edited and transgenic crops don't pose new risks compared to conventionally bred varieties. According to the report, the average cost of developing and authorizing a new plant biotech trait was $115 million based on 2017 to 2022 data from the four largest biotech companies, with 29% devoted to regulatory science and 9% to registration and regulatory affairs.
The report explains that conventional breeding methods often introduce more genetic uncertainty than modern genetic engineering, with the National Biotechnology Policy Board concluding as early as 1992 that biotechnology processes tend to reduce risks due to better precision. Regulatory divergence has heavily shaped where biotech companies focus their research and development—following a 2018 European Court of Justice ruling that gene-edited crops must be regulated as GMOs, over a third of companies working on gene-editing research scaled back or halted their programs, and the largest companies redirected product pipelines to more favorable markets. The EU's new framework provides an opening for those companies to reinvest in Europe, while streamlining US regulations could lower barriers for small businesses, universities, and nonprofits pursuing improvements to specialty and regional crops that larger commercial developers have little incentive to prioritize. The report notes that modifications boosting yields foster land-sparing effects that mitigate global deforestation, while faster approvals for pest- and disease-resistant traits will enable farmers to reduce the volume and toxicity of chemical crop protection applications.
The report recommends that the US move forward with a regulatory overhaul to evaluate modified organisms no differently than conventional products, with USDA putting forward new rulemaking to move away from Part 340 regulations and Congress passing legislation to address remaining barriers and provide oversight. The authors argue that establishing congressional intent will provide certainty that regulatory changes endure across future administrations. These recent actions in the EU and under consideration in the US demonstrate what the report calls "a growing global consensus that agricultural success amidst growing food demand and mounting production challenges will require leaving the precautionary principle behind."