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March 17, 2011

Obama Administration Sets Forth Principles for Regulation and Oversight of Emerging Technologies

Lynn L. Bergeson

March 11, 2011, memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) sets forth the Obama Administration’s principles for regulation and oversight of emerging technologies, including nanotechnology. The ETIPC Co-Chairs include John P. Holdren, Assistant to the President for Science and Technology, Director, Office of Science and Technology Policy (OSTP); Cass R. Sunstein, Administrator, Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB); and Islam A. Siddiqui, Chief Agricultural Negotiator, U.S. Trade Representative.

 The memorandum to the heads of executive departments and agencies outlines the following broad principles intended to guide the development and implementation of policies for oversight of emerging technologies at the agency level:

  • Scientific Integrity: Federal regulation and oversight of emerging technologies should be based on the best available scientific evidence;
  • Public Participation: To the extent feasible, relevant information should be developed with ample opportunities for stakeholder involvement and public participation;
  • Communication: The federal government should actively communicate information to the public regarding the potential benefits and risks associated with new technologies;
  • Benefits and Costs: Federal regulation and oversight of emerging technologies should be based on an awareness of the potential benefits and the potential costs of such regulation and oversight;
  • Flexibility: Federal regulation and oversight should provide sufficient flexibility to accommodate new evidence and learning and to take into account the evolving nature of information related to emerging technologies and their applications;
  • Risk Assessment and Risk Management: Risk assessment should be distinguished from risk management;
  • Coordination: Federal agencies should seek to coordinate with one another, with state authorities, and with stakeholders to address the breadth of issues associated with the commercialization of an emerging technology, in an effort to craft a coherent approach;
  • International Cooperation: The federal government should encourage coordinated and collaborative research across the international community; and
  • Regulation: The federal government should adhere to President Obama’s January 21, 2011, Executive Order 13563 and, consistent with that Order, the following principles when regulating emerging technologies:
  • Decisions should be based on the best reasonably obtainable scientific, technical, economic, and other information;
  • Regulations should be developed with a firm commitment to fair notice and to public participation;
  • The benefits of regulation should justify the costs;
  • Where possible, regulatory approaches should promote innovation while also advancing regulatory objectives, such as protection of health, the environment, and safety;
  • When no significant oversight issue based on a sufficiently distinguishing attribute of the technology or the relevant application can be identified, agencies should consider the option not to regulate;
  • Where possible, regulatory approaches should be performance-based and provide predictability and flexibility in the face of fresh evidence and evolving information; and
    Regulatory approaches shall comply with established requirements and guidance.