Outlaws, old laws and no laws: the prospects of gene editing for agriculture in United States.

Abstract

The advent of genome-edited products that are nearing commercialization in agriculture has highlighted that the US biotechnology regulatory system has not kept pace with technological advances. Of the three agencies that regulate engineered crops and animals for agriculture, only one has indicated how it will regulate edited plants. The Food and Drug Administration can regulate any plant, but has not indicated if it will single out edited plants. The US Department of Agriculture currently has no authority over edited plants when the edit is a deletion or does not contain any added DNA from a plant pest. Depending on how the statutes are interpreted, the Environmental Protection Agency might be able to regulate plants edited to tolerate pests and diseases. Labeling requirements also remain undefined. Regardless, sectors of the industry and some consumer groups are uneasy over editing technology, and may be the ultimate arbiters of whether edited products make it to market.