The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.
EPA, FDA, and USDA Release Updates to Coordinated Framework on Biotechnology
On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in 1992. The White House states that this is “an important step to ensure public confidence in the regulatory system for biotechnology products and to improve the transparency, predictability, coordination, and, ultimately, efficiency of that system.” The documents released are:
The Update document is intended to help product developers and the public understand what the regulatory pathway for products might look like. The White House states that the Update document presents information about agency roles and responsibilities in several forms, including:
The White House is seeking public comment on this proposed Update. The comment deadline will be 40 days from the date of publication in the Federal Register.
The Strategy document, which the White House states “sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens,” also details many existing activities at EPA, FDA, and USDA; new activities that have been instigated by the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” which directed EPA, FDA, and USDA to update the Coordinated Framework; and key commitments that these three agencies will keep going forward to continue the modernization process. These commitments are:
On Tuesday, September 20, 2016, at 2:00 p.m. (EDT), OSTP, EPA, FDA, and USDA will be participating in a conference call on the White House’s efforts in regards to the above. More information regarding registration for the call and submitting questions is available online.
More information concerning the Coordinated Framework, the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” and other current biotechnology issues are available in our memoranda on our website under the key phrase “Biobased Products, Biotechnology.”