USDA’s actions on gene-edited approvals challenged in court

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In May 2020, the previous administration’s USDA issued its final rule to modernize agricultural biotechnology regulations. Of note was revised regulations for evaluating new technologies developed using gene editing. Now environmental groups have challenged the decision to eliminate some of the regulatory requirements for genetically engineered organisms including future GE crops, trees and grasses.

Under the previous regulations, the Animal Plant Health Inspection Service assessed the plant pest risk of each plant transformation event (also sometimes referred to as the individual transformed line, transgenic line, or genetically-engineered line) separately, even though the inserted genetic material may have been identical or very similar to transformation events already assessed. This has sometimes been referred to as an “event-by-event” approach.  

Under the revised regulations, developers have the option of requesting a permit or a regulatory status review of a plant developed using genetic engineering that has not been previously evaluated and determined to be nonregulated. This process replaces the petition process in the previous regulations. 

In announcing the rule, USDA says the final rule...