The original ‘1986 Coordinated Framework for the Regulation of Biotechnology’ and the ‘Update in 1992’ served to regulate biotechnology products in the United States and ensure protection of both human health and the environment. However, advances in science and technology means new types of products not originally envisioned are entering the market. Further, the biotechnology regulatory system is complex, spanning three agencies [the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)] which can make it difficult for small businesses to navigate. In response to this, the Executive Office of the President (EOP) asked in a 2015 memorandum for EPA, FDA and USDA to:
1. Clarify current roles and responsibilities of each agency (EPA, FDA, USDA) in regulating biotechnology products (Update to the Coordinated Framework; below);
2. Develop a long-term strategy so the regulatory system can anticipate the future of biotechnology products (The National Strategy; see future blog post);
3. Take a snapshot of emerging biotechnology to analyze what products might look like in the future (Report on the Future of Biotechnology, to be released by the National Academy of Science; see future blog post).
The first of these three objectives has been completed and the final version was released on January 4, 2017. Entitled “Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology” (2017 Update to the Coordinated Framework) it includes:
1. Clarifying which agency (FDA, EPA or USDA) has authority to regulate the various types of biotechnology products;
2. Clarifying the roles of each agency for the various types of biotechnology products; and where the roles span multiple agencies;
Of particular interest to our readers, Table 2 in the 2017 Update to the Coordinated Framework is a comprehensive table that summarizes the current responsibilities and coordination of the various offices spanning EPA, FDA, and USDA, organized by biotechnology product area. It allows businesses to look up their biotechnology product, providing quick reference to the offices overseeing its regulation.
3. Clarifying a mechanism for communication and coordination among agencies;
4. Clarifying a mechanism for regularly reviewing (and updating) the Coordinated Framework.
The full version of the 2017 Update to the Coordinated Framework is available here.