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March 18, 2016

Biotechnology:  NAS to Study Future Products of Biotechnology

Bergeson & Campbell, P.C.

On March 18, 2016, the National Academies of Science, Engineering, and Medicine (NAS) announced the appointment of its provisional committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This study is being commissioned pursuant to the White House Office of Science and Technology Policy’s (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” that states it would “commission an external, independent analysis of the future landscape of biotechnology products.” Candidates for inclusion on NAS’ panel were solicited in January 2016. More information regarding the July 2 memorandum and its implementation are available on our website under the category Biobased Products, Biotechnology. Consistent with OSTP’s July 2, 2015, memorandum announcing the modernizing of the Coordinated Framework, the ad hoc committee will begin the study to provide an independent and objective examination of the future products of biotechnology that will include:

  • Describing the major advances and the potential new types of biotechnology products likely to emerge over the next five to ten years;
  • Describing the existing risk analysis system for biotechnology products, including but not limited to risk analyses developed and used by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA), and describing each agency’s authorities as they pertain to the products of biotechnology;
  • Determining whether potential future products could pose different types of risks relative to existing products and organisms (where appropriate, identifying areas in which the risks or lack of risks relating to the products of biotechnology are well understood); and
  • Indicating what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.

The provisional committee members are:

  • Richard Murray, California Institute of Technology;
  • Richard M. Amasino, University of Wisconsin, Madison;
  • Steven P. Bradbury, Iowa State University;
  • Barbara Evans, University of Houston Law Center;
  • Steven L. Evans, Dow AgroSciences;
  • Farren Isaacs, Yale University;
  • Richard Johnson, Global Helix LLC;
  • Martha Krebs, Pennsylvania State University;
  • Jennifer Kuzma, North Carolina State University;
  • Mary Maxon, Lawrence Berkeley National Laboratory;
  • Raul F. Medina, Texas A&M University;
  • David Rejeski, Woodrow Wilson Center for International Scholars; and
  • Jeffrey Wolt, Iowa State University.

The committee members’ biographies are available online. Formal comments on the committee appointments are due by April 6, 2016. Comments can be submitted online through NAS’ current projects system. The committee will hold its first public meeting on April 18, 2016, in Washington, D.C. Registration, available online, is strongly encouraged for in-person attendance and for viewing the webcast. A report on the committee’s study is expected to be released at the end of 2016.

There have been two public meetings on the July 2 memorandum. The third and final meeting is scheduled for March 30, 2016, at the University of California’s Davis Conference Center in Davis, California. At this public meeting, EPA, FDA, USDA, and OSTP representatives will review progress made on efforts to modernize the regulatory system for biotechnology products and will illustrate the current roles and responsibilities of EPA, FDA, and USDA regarding biotechnology products by discussing case studies of hypothetical products. There will also be several opportunities for questions and answers to clarify the information presented during the case studies, as outlined in the agenda. Registration is available for this meeting online. Additional details on the March 30, 2016, public meeting are available on USDA’s webpage.

Many of the topics likely to be considered by NAS’ committee are addressed in the report that Bergeson & Campbell, P.C. (B&C®) legal experts, scientists, and policy specialists prepared for the Woodrow Wilson International Center for Scholars Synthetic Biology Project, The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?. This report includes a survey of the current commercial applications of synthetic biology, analysis of issues facing U.S. regulatory systems and agencies called into play by products of synthetic biology, case studies illustrative of how novel technologies challenge the regulatory infrastructure and can induce competing and sometimes conflicting jurisdictional oversight, and a review of recommendations for improvement, including those contained in the July 2, 2015, memorandum.