Three decades into the agricultural biotechnology era, the USDA said on Thursday that it will exempt genetically engineered plants from pre-market reviews if they are unlikely to pose an environmental risk. Although Agriculture Secretary Sonny Perdue said the new regulatory approach will streamline innovation, an amalgam of opponents said it means “a majority of genetically engineered and gene-edited plants will now escape any oversight” by the USDA.
The new regulation, dubbed SECURE by the USDA, comes 11 months after President Trump told the three federal regulators of biotechnology — the USDA, FDA, and EPA — to modernize their handling of ag biotech. Referring to gene-edited crops and animals, Trump said in an executive order that the agencies should “exempt low-risk products of agriculture biotechnology from undue regulation.”
The biotechnology industry says gene editing is a safe and speedier way to produce plants with traits that could have been developed by traditional breeding techniques. U.S. agricultural and trade groups say a modernized regulatory framework is needed to assure both U.S. preeminence in the field and a safe food supply for a growing population.
Perdue said the new regulation, which will take effect 90 days after appearing in the Federal Register, is “the first significant update to our plant biotechnology regulations in more than three decades.”
Under the new regulation, the Animal and Plant Health Inspection Service “will evaluate plants developed using genetic engineering for plant pest risk under a new process called a regulatory status review, regulating only those that plausibly pose an increased plant pest risk,” said the USDA.
Until now, all GMO plants needed USDA approval before they could be commercialized. The requirement was based on the USDA’s authority to prevent the introduction of plant pests. The agency said its “regulatory scientists know that simply using a plant pest in the development of a plant does not necessarily cause the plant to pose a risk to plant health. Thus, the final rule puts in place a more efficient process to identify plants that would be subject to regulation, focusing on the properties of the plant rather than on its method of production.”
Classical biotechnology relied on the insertion of genetic material from a foreign organism into the genes of plants. With the development of gene-editing techniques such as CRISPR, scientists can manipulate the makeup of a plant’s genes. Perdue said in 2018 that the USDA would not regulate plants developed through gene editing unless they pose a pest or noxious weed threat.
The Center for Science in the Public Interest, a consumer group, said the USDA was leaving it to crop developers to decide if their creations would be subject to USDA regulation. “The result is that government regulators and the public will have no idea what products will enter the market and whether those products appropriately qualified for an exemption from oversight,” said Gregory Jaffe, a CSPI biotechnology expert. “They will stealthily enter our food supply at a time when consumers want greater transparency, leading to potential consumer backlash and acceptance problems, even for safe and beneficial products.”
Biotechnology Innovation Organization, a trade group, said the new regulation would maintain government oversight of the novel crops while accelerating development of new products. “BIO understands that consumers want more information about what is in their food and whether their food is safe,” said Dana O’Brien, BIO executive vice president for food.
The American Seed Trade Association said the new USDA regulation recognized that gene editing results in plant varieties “that are essentially equivalent to varieties developed through more traditional breeding methods,” so they do not need extensive government review. “USDA also rightly recognizes the continuing evolution of the science of plant breeding and, thus, has included a mechanism for additional exemptions,” it said.
To read the USDA biotechnology rule, click here.