The administration launched an update of its multi-agency system of regulating food and agricultural biotechnology with a goal of writing the new version of its “coordinated framework” by July 2016. The three major actors in biotech regulation, the FDA, the USDA and the EPA, are leading the overhaul. The last time the coordinated framework was modernized was 1992. The new framework will spell out the roles of each agency and its area of jurisdiction. The White House said it wants “to increase the transparency, coordination, predictability and efficiency of the regulatory system for the products of biotechnology.”
“Advances in science and technology, moreover, have dramatically altered the biotechnology landscape since the 1992 update …. Such advances can enable development of products that were not previously possible,” said the White House, after noting obstacles to small and medium-size companies that want to enter the biotech business. Businesses have complained that federal review of products takes too long and is expensive.
There will be three “public engagement sessions” as part of the modernization, with the first of the listening sessions this fall in Washington. The updated framework will be subject to a public comment period before it is adopted.
The consumer group Center for Science in the Public Interest said the FDA should play a more substantial role in the approval process for genetically engineered foods as a way to satisfy public concerns about GE crop safety. It also said the USDA should cover all GE crops, “not just those that are designed with ‘plant pest’ components.” Most GE crops are created through the addition of a gene from another organism, which means the USDA can regulate them under plant-protection laws. New techniques involve the use of genes already present in plants, rather than a foreign organism, and have raised questions if they are included in the regulatory system.
A trade group, the Biotechnology Industry Organization, said it welcomed the update as a way to encourage innovation in the industry. “Critics of biotechnology crops have long said that the current system is too lax, and they will no doubt push for tougher regulations,” the New York Times reports.