US Department of Agriculture will not Regulate Gene-Edited Crops

The US Secretary of Agriculture recently announced that the US Department of Agriculture will not regulate gene-edited crops.  As the Futurist explains, this is different than genetically modified crops, which will continue to be regulated.  In a document titled, “Details on USDA Plant Breeding Innovations,” the USDA states: 

USDA is committed to helping farmers produce healthy, affordable food in a sustainable manner that protects this country’s natural resources and offers more choices for consumers. Through innovative methods, plant scientists can now create new plant varieties that are indistinguishable from those developed through traditional breeding methods. These new approaches to plant breeding include methods like genome editing and present tremendous opportunities for farmers and consumers alike by making available plants with traits that may protect crops against threats like drought and diseases, increase nutritional value, and eliminate allergens. 

In keeping with our responsibility to protect plant health, USDA has carefully reviewed products of these new technologies to determine whether they require regulatory oversight. 

As USDA works to modernize its biotechnology regulations, the vision and direction of this Department will be to continue to focus regulatory initiatives on the basis of risk to plant health. 

Under its biotechnology regulations, USDA does not currently regulate, or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests. This can include plant varieties with the following changes: 

• Deletions—the change to the plant is solely a genetic deletion of any size.
  
• Single base pair substitutions—the change to the plant is a single base pair substitution.
  
• Insertions from compatible plant relatives—the change to the plant solely introduces nucleic acid sequences from a compatible relative that could otherwise cross with the recipient organism and produce viable progeny through traditional breeding.
  
• Complete Null Segregants—off-spring of a genetically engineered plant that does not retain the change of its parent.

The Press Release also notes that other agencies also regulate biotechnology innovations, such as the Food and Drug Administration and the Environmental Protection Agency.  For more on access to the CRISPR technology, see this IP Finance post.