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July 10, 2015

White House And Agencies Release Coordinated Biotechnology Regulatory Framework


With little fanfare or advanced notice to the general public, 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 directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products. A July 2, 2015, OSTP blog item entitled "Improving Transparency and Ensuring Continued Safety in Biotechnology" notes that the complexity of the array of regulations and guidance documents developed by 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 to the Coordinated Framework "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 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." Improvements must:

  • Maintain high standards that are based on the best available science and that deliver appropriate health and environmental protection;
  • Establish transparent, coordinated, predictable, and efficient regulatory practices across agencies with overlapping jurisdiction; and
  • Promote public confidence in the oversight of the products of biotechnology through clear and transparent public engagement.

BRAG affiliate Bergeson & Campbell, P.C.'s (B&C®) full memorandum, "Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology," is available online.