With little fanfare, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum could have significant implications for innovators in the biotechnology and synthetic biology commercial space.
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Background
A July 2, 2015, OSTP blog item notes that the complexity of the array of regulations and guidance documents developed by the EPA, FDA, and USDA “can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.” The memorandum states that the objectives “are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.”
The Coordinated Framework describes the federal regulatory policy intended to ensure the safety of biotechnology products. The 1992 update “sets forth a risk-based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment.” According to the memorandum, the 1992 update affirmed that federal oversight should focus on the characteristics of the product and the environment into which it is being introduced, rather than the process by which the product is created. The memorandum states that federal agencies regulating biotechnology products “should continually strive to improve predictability, increase efficiency, and reduce uncertainty in their regulatory processes and requirements.”
The memorandum initiates a process to help advance these aims, beginning with the following one-year objectives: (1) development of an updated Coordinated Framework to clarify the roles and responsibilities of the agencies that regulate biotechnology products; (2) formulation of a long-term strategy to ensure 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, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens; and (3) commissioning an external, independent analysis of the future landscape of biotechnology products.
The OSTP blog states that the Administration recognizes the importance of public engagement throughout this process. As part of this process, the Administration will hold three public engagement sessions over the year in different regions of the country. The first listening session will occur in Washington, D.C., in fall 2015. According to the OSTP, the update to the Coordinated Framework will undergo public notice and comment before it is issued in final form.
Discussion
Modernizing the Coordinated Framework is critical. For years now, efforts have been underway to modernize the Toxic Substances Control Act (TSCA) and right now there is reason to believe TSCA reform legislation may be enacted this year. Despite the significant role TSCA plays in the U.S. regulatory system for biotechnology products, curiously, there has been virtually no discussion of, or attention given to, TSCA’s application to these products. That the modernizing of the Coordinated Framework will occur on a separate trajectory, perhaps in parallel with implementing TSCA reform legislation should it happen this year, poses both risks and opportunities.
The Administration’s decision to modernize the Coordinated Framework is welcome news. If TSCA reform legislation is enacted, the tricky part will be ensuring that the modernizing of TSCA and the Coordinated Framework are aligned. If TSCA reform legislation does not advance this year, it will be interesting to see how the two initiatives progress in tandem.
