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28 December 20222 minute read

Another look at the coordinated framework for the regulation of biotechnology

The White House recently announced it is seeking additional information related to the 1986 Coordinated Framework for the Regulation of Biotechnology (the Coordinated Framework), which describes the federal system for evaluating products developed using modern biotechnology.

Under this framework, the Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and US Department of Agriculture (USDA) each play a role in overseeing the safety, labeling and, if applicable, effectiveness of biotechnology products. Depending on its characteristics, a product may be subject to the jurisdiction of one or more of these agencies. 

Since the Coordinated Framework was implemented, the landscape of products made from biotechnology has evolved with a myriad of new and emerging biotechnology products. In response, the White House Office of Science and Technology Policy (OSTP) has issued a Federal Register Notice opening a docket for additional data and information to help identify regulatory ambiguities, gaps, inefficiencies or uncertainties in the Coordinated Framework.  Although the docket will be managed by USDA, all three agencies will be considering the comments submitted.

The docket will remain open until February 3, 2023.  In addition to the docket, the regulatory agencies will be hosting a virtual listening session on January 12, 2023Registration for the session is now open.

This action furthers an earlier Executive order issued in September of this year to launch the National Biotechnology and Biomanufacturing Initiative (NBBI).  The NBBI is intended to promote and accelerate the biotechnology industry in the US across multiple sectors, including health, agriculture and energy. 

Please contact the author or your usual DLA Piper attorney with any questions.