The Obama Administration’s update of a decades-old policy for reviewing U.S. biotechnology products is perhaps most notable for what it leaves out: a call for new regulations on or a mention of new gene-editing technologies such as CRISPR.
Released on Jan. 4, the revision for the first time sets down in a single document the roles of U.S. agencies involved in regulating products of biotechnology, says Robbie Barbero of the White House Office of Science & Technology Policy (OSTP).
The Reagan Administration first addressed the stream of new genetically manipulated products through the Coordinated Framework for the Regulation of Biotechnology in 1986. Rather than calling for new statutes, the framework simply specifies which existing laws authorize the Agriculture Department, FDA, and EPA to review such products. It was last updated in 1992.
Barbero says the update to the framework “was really meant to be ground truth for how the system functions now.”Absent in the new document is mention of the popular CRISPR gene-editing technique. CRISPR-edited foods are already cropping up, including a mushroom that USDA said it would not regulate because it didn’t use plant pest parts—a formerly common genetic engineering method that serves as USDA’s hook for reviewing engineered crops.
“In some instances, the agencies are hamstrung and unable to adapt to these rapidly changing technologies. And that can only get fixed by actually changing the regulation,” says Todd Kuiken of the Genetic Engineering & Society Center at North Carolina State University. “We will continue to see these problems emerge. It is CRISPR today, but tomorrow it will be something else.”
Doug Gurian-Sherman of the Center for Food Safety, an environmental advocacy organization, says that without calling for new regulations, the revised framework “is really just kicking the can down the road.”
The Biotechnology Innovation Organization, an industry group, says that it is reviewing the updated framework and that it supports efforts to modernize the regulatory system for biotechnology products.