Many new genetically engineered crop traits would be exempt from regulation by the Agriculture Department under a sweeping rewrite of its rules for testing and assessing the products.
The latest overhaul plan is the third such proposal released by USDA since 2008 and is aimed at streamlining and reducing the cost of the development of new crop traits.
Under the new proposed rule, modified plants would be exempted from regulation because they could be produced through traditional breeding techniques, making them unlikely to pose a greater plant pest risk than conventionally bred crops.
The rule would also allow crop developers to make a “self-determination” that their crops are exempt from regulation. They could seek confirmation letters from USDA of the exempt status or ask USDA to determine whether the trait is regulated or not.
“This common sense approach will ultimately give farmers more choices in the field and consumers more choices at the grocery store,” said Greg Ibach, USDA’s undersecretary for marketing and regulatory programs.
The rule wouldn’t affect the oversight roles of the Food and Drug Administration, which is responsible for food safety, and Environmental Protection Agency which regulates biotech plants that have pesticidal properties.
USDA estimates that the proposed rule would save developers an average of $3.6 million in compliance costs on a single genetically engineered plant, so long as the trait doesn’t fall under the purview of FDA or EPA. If either or both of those agencies have an oversight role, the savings would average just $730,000.
The USDA proposal “will provide a clear, predictable, and efficient regulatory pathway for innovators while facilitating the development of new and novel GE plants that are unlikely to pose a plant pest risk,” according to the 109-page rule.
“It will protect the health and value of America’s agriculture and natural resources and help foster safe and predictable agricultural trade worldwide. We anticipate that adopting the new framework will result in significant savings for developers of GE organisms.”
The rule replaces a proposal released in January 2017 by the Obama administration. That rule also sought to streamline the regulatory process, but USDA’s Animal and Plant Health Inspection Service says in the latest proposal that many critics of that Obama-era rule felt it “would be too burdensome and had the potential to stifle innovation.”
The rule leaves unclear how crops developed for industrial or pharmaceutical uses would be regulated.
APHIS says those crops would have to be regulated under a different section of the law or under a new law to clarify the federal authority for those traits. “APHIS does not prefer one of these options over the other, nor does the agency consider the two options necessarily to be exhaustive,” the proposed rule says.
The American Seed Trade Association welcomed the proposed rule. “We’re pleased that USDA is taking much-needed action to update our nation’s policies to reflect the latest scientific advancements in agriculture," said ASTA President and CEO Andy LaVigne. "As plant scientists continue the rapid pace of discovery in plant genetics and biology, it’s critical that the U.S. lead with policies that reflect, and support, the ongoing evolution of plant breeding."
The Center for Food Safety, an advocacy group that has challenged USDA in court over genetically engineered crops, said its biotech regulations need to be strengthened.
"In general, USDA regulation of GE plants has long been inadequate and must be substantially improved. USDA must use this opportunity to protect the environment as well as traditional farmers from the significant adverse impacts of GE crops - which include, but are not limited to - transgenic contamination, significantly increased pesticide use, and pesticide-resistant super-weeds," the group said in a statement.
A 60-day comment period on the rule starts Friday.
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