The U.S. Department of Agriculture says it will not regulate most crops modified with gene-editing techniques such as CRISPR. In a statement released March 28, USDA secretary Sonny Purdue said that gene editing is equivalent to techniques traditionally used by plant breeders to generate beneficial traits and does not carry additional risks that require oversight.
Until now, companies developing gene-edited crops had to request clarification via letter to find out if the agency would regulate their product. In each case, USDA responded that it would not.
The agency outlined the gene-editing methods it considers equivalent to common plant breeding techniques, such as hybridization and mutagenesis via chemicals or radiation. The equivalent methods include DNA deletions of any size, single-base-pair substitutions, and insertions of DNA from plant relatives. The agency will continue to regulate genetically modified crops that contain genes from other species to protect the agriculture industry from plant pests.
Because USDA hasn’t opted to review gene-edited crops currently under development, such as a non-browning mushroom and a new type of waxy corn, the new blanket policy does not signify a change of heart. But it took some industry watchers by surprise.
“I wasn’t expecting this, and I don’t know what prompted it,” says Greg Jaffe, biotechnology project director for consumer advocacy group Center for Science in the Public Interest. He says limiting the risk assessment to plant pest risks doesn’t account for for other types of risk, including any to human health. Human health concerns are the purview of the FDA.
But seed and plant breeding companies hailed the announcement, saying it affirms that gene-edited crops are no more risky than any other new plant varieties. “This eliminates a huge barrier to market entry, saving time and potentially tens of millions of dollars,” says Oliver Peoples, CEO of Yield10 Bioscience, developer of a gene-edited variety of the industrial oilseed crop Camelina sativa. The American Seed Trade Association, whose members include Monsanto, add that the clarification was needed and will “help ensure that U.S. agriculture remains at the forefront of innovation and maintains its leadership role globally.”