Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology

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.

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 the products of biotechnology; (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. According to the memorandum, the following elements will support the process to achieve these objectives:

• Biotechnology Working Group Under the Emerging Technologies Interagency Policy Coordination Committee: The Biotechnology Working Group will include representatives from the Executive Office of the President, EPA, FDA, and USDA.
   
• Mission and Function of the Biotechnology Working Group: Within one year of the date of the memorandum, the Biotechnology Working Group shall take steps detailed below and others, as appropriate, to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology. The Working Group will:
  
  1. Update the Coordinated Framework to clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology, after input from the public; and
      
  2. Develop 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, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.
      
• Independent Assessment: EPA, FDA, and USDA shall commission an external, independent analysis of the future landscape of biotechnology products that will identify (1) potential new risks and frameworks for risk assessment, and (2) areas in which the risks or lack of risks relating to the products of biotechnology are well understood. The review will help inform future policy making. Due to the rapid pace of change in this arena, an external analysis should be completed at least every five years.
   
• Budgeting for Efficiency: EPA, FDA, and USDA shall work with OSTP and OMB, within the annual President’s budget formulation process, to develop a plan for supporting the implementation of this memo in agency fiscal year (FY) 2017 budget requests and, as appropriate, in future budget submissions.
   
• Annual Reporting: For at least five years, starting one year after the release of the strategy described above, the Biotechnology Working Group will produce an annual report on specific steps that agencies are taking to implement that strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products. This report will be made available to the public by the Executive Office of the President.
   

The OSTP blog item 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 blog item, the update to the Coordinated Framework will undergo public notice and comment before it is issued in final. The blog item includes a link to sign up to be kept up to date on these activities.

Commentary

Modernizing seems to be the word de jure. For years now, efforts have been underway to modernize the Toxic Substances Control Act (TSCA) and as we speak 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 products of biotechnology, curiously there has been virtually no discussion of or attention given to TSCA’s application to products of biotechnology. 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.

That the Coordinated Framework needs a do over is clear. A number of recent reports have convincingly outlined the reasons why the Coordinated Framework can no longer nimbly, clearly, or comprehensively regulate products of biotechnology and call for exactly what the Administration announced on July 2. Last year, the Venter Institute issued a landmark analysis of the domestic biotechnology regulatory system in which it highlighted the critical need for modernizing the Coordinated Framework. J. Craig Venter Institute. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (May 2014). More recently, the National Research Council of the National Academies issued, on March 13, 2015, Industrialization of Biology: A Roadmap to Accelerate the Advance Manufacturing of Chemicals. The report, prepared by the Board on Chemical Sciences and Technology, Board on Life Sciences, Division on Earth and Life Studies, identified the challenges and opportunities posed by the current regulatory system relating to biotechnology and synthetic biology.

The Woodrow Wilson International Center for Scholars Synthetic Biology Project issued a statement praising the Administration’s decision: “The Synthetic Biology Project supports the effort by the White House Office of Science and Technology Policy (OSTP) to update the Coordinated Framework for the Regulation of Biotechnology to address emerging technologies like synthetic biology.” The statement goes on to say: “We see this as a positive development and one that is long overdue considering the rapid advancement of biotech-related fields like synthetic biology.”

A forthcoming report from the Synthetic Biology Project examines the regulatory pathways of new applications that are close to entering the market. That report finds confusion about the regulatory jurisdiction of different agencies in the framework and questions which statutes apply to the applications. Earlier this year, the Project released an interactive, crowdsourced inventory to track applications and products that utilize synthetic biology techniques.

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 modernizing of 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.