March: Gene-Editing Regulation Roundup

In this Roundup, the MoFo Food & Ag team aims to help our clients proactively track gene-editing regulation to inform business strategy.

North America Regulations

Current Overview: Genetically engineered (GE) organisms in the United States are regulated under the Coordinated Framework, which allocates oversight among EPA, FDA, and USDA based on product characteristics and use. EPA registers pesticidal traits. FDA conducts premarket consultations for food and feed safety. And USDA Animal and Plant Health Inspection Service (APHIS) regulates GE plants for plant pest risk. Recent developments include the following:

• Decibel Bio, Inc, a Gates Foundation backed startup, had Corn, Tomato, and Lettuce plants confirmed to be not regulated under 7 CFR 340. Decibel is using epigenetics to modify its crops.
• Key Takeaways:
• Plant genome editing is not limited to changing the DNA.
• Epigenetic approaches may be a new space to explore in crop improvement.

• APHIS Biotechnology Regulatory Services (BRS) held its annual stakeholders meeting on February 26. See the full summary in our recent client alert.

• Highlights Include:

• APHIS issued more permits for microbes and invertebrates in 2025 than in 2024.

• Key Takeaways:

• Early consultation with APHIS BRS can reduce review friction and improve timeline predictability for regulated biotech crop field trial permits.

• The plant microbiome remains a significant and expanding focus for crop innovation and regulatory activity.

Europe Regulations

Current Overview: Gene-edited organisms are regulated similarly to 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 proposed regulation on “new genomic techniques” is set to be presented to European Parliament in the coming months.
• Key Takeaways: 
• The proposed regulations are moving toward reality with the coming months possibly bringing very exciting news.

England Regulations

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.

• A Camelina sativa plant (oil-seed crop) genetically engineered to have larger seeds is among the first plants set for release under the Genetic Technology (Precision Breeding) Act.
• Key Takeaways:
• The new regulations, including the notification system, are up and running.

China Regulations

Regulations for gene-edited plants in China currently occupy a middle ground between the U.S. and Europe. China has streamlined regulations for GE crops that do not contain foreign DNA, but some testing and a biosafety certificate are still required.

• Chinese Patent Office Regulations clarifying the definition of a plant variety went into effect in January 2026. In brief, a plant variety is artificially selected with consistent characteristics and relatively stable genetics. China does not allow plant varieties to be patented, and these clarifications should offer plant breeders increased clarity on the scope of what is a “plant variety” before the Patent Office. Despite not being patentable, new plant varieties can still obtain intellectual property protection in China via their Plant Variety Rights (PVR) system, which is administered under the framework of the International Union for the Protection of New Varieties of Plants (UPOV).
• Key Takeaways:
• China offers breeders of new plant varieties increased clarity on IP protection at the Patent Office vs. the PVR Office.     

[1] “These Regulations extend to England and Wales but apply in England only.”