North America Regulation
Current Overview: Genetically engineered (GE) organisms in the United States are subject to regulation from the EPA for environmental concerns, the FDA for food and drug concerns, and the USDA for agricultural concerns. Under the USDA, the Animal and Plant Health Inspection Service (APHIS) is the main body responsible for approving new GE varieties of plants. APHIS has a streamlined process for plants that have gene edits that could have been achieved through traditional means. Recent developments include the following:
- Ishihara Sangyo Kaisha, Ltd. received deregulation status for genetically engineered moth orchids that produce blue-purple flowers.
- Key takeaway:
- Genetic engineering technology continues to be widely used to generate new plant traits, including in ornamental plants.
- The legal future of hemp, cannabis plants that produce extremely low levels of THC, is currently in flux. The U.S. House of Representatives (sections 740 and 759) and Senate (sections 737 and 781) continue to debate language in the current federal Agriculture Appropriations Act before it takes effect on November 12, 2026.
- Key takeaway:
- Those in the hemp industry should be planning contingencies as the legality of hemp is set to change.
- The USPTO is now requiring breeding history to obtain utility patent coverage of varieties. This marks a departure from the USPTO’s previous practice, in which it was possible to maintain the breeding history as a trade secret in some cases.
- Key takeaway:
- Updates to USPTO procedures mean that maintaining the breeding history as a trade secret is no longer a viable option.
Europe Regulation
Current Overview: All gene-edited organisms are regulated in the same way as genetically modified organisms (i.e., organisms that have foreign DNA). That framework is now under active review, with the European Commission proposing a new regulatory regime for certain “new genomic techniques” that would distinguish some gene-edited organisms from traditional genetically modified organisms and, potentially, treat them more like conventionally bred crops. Recent news includes the following:
- On January 28, 2026 the European parliament’s Committee on the Environment approved the December 4, 2025 preliminary agreement on a comprehensive framework for New Genomic Techniques (NGTs).
- Key takeaways:
- This is a very promising step toward science-guided regulation and an accessible European market for NGT products.
- The Council of the European Union and the European parliament reached a preliminary agreement on a comprehensive framework for New Genomic Techniques (NGTs) on December 4, 2025.
- Key takeaways:
- Divides gene-edited organisms into NGT-1 (changes that could have been made via conventional breeding practices) and NGT-2 (all other NGT plants).
- NGT-1 organisms will be subject to a new, less stringent regulatory process while NGT-2 plants will still be subject to existing GMO regulations.
- Patents on NGT-related inventions will be permitted but will have additional transparency requirements.
England Regulation
Current Overview: The Genetic Technology (Precision Breeding) Act 2023 went into effect in England[1] on November 13, 2025. The new regulations allow for streamlined approval of certain genetically engineered plants.
- Key takeaways:
- Precision-Bred Organisms (e.g., organisms having genetic changes that could have been achieved naturally or through conventional techniques) will be regulated differently in Europe than in England at least for the time being, currently making England a more accessible market for new gene-edited plants.
[1] “These Regulations extend to England and Wales but apply in England only.”
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