November 1, 2016
National Science and Technology Council:
Emerging Technologies Interagency Policy Coordination Committee
Office of Science and Technology Policy
1650 Pennsylvania Avenue NW
Washington, DC 20504
Re: Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology
Dear Sir or Madam:
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the Notice of Request for Public Comment published by the National Science and Technology Council, Science and Technology Policy Office. BIO is the world's largest biotechnology trade association, representing more than 950 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. Our members are involved in the research and development of healthcare, agricultural, food, industrial and environmental biotechnology products, and BIO represents the majority of the biotechnology product developers in North America.
The Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) has made it possible for BIO members to develop products that have improved the productivity of plant and animal agriculture while decreasing their environmental impacts, enhanced food safety and quality, increased the use of renewable resources and decreased manufacturing costs and energy use. Consequently, BIO is especially interested in the Administration’s efforts to clarify the roles and responsibilities described in the Coordinated Framework, and we appreciate the opportunity to provide comments.
In a series of Executive Orders (EOs) and memos, most notably EO 13563, EO 13610 and its memo on principles for regulation and oversight of emerging technologies3, the Administration has clearly described the importance of appropriate regulation to economic growth and innovation, while continuing to meet the requisite objectives of protecting the health of humans, animals and the environment. BIO members concur with the Administration’s view that “regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.” As such, BIO supports the objectives of this initiative, as articulated in the July 2015 memorandum from the Executive Office of the President (EOP), which are to:
- ensure public confidence in the regulatory system, and
- prevent unnecessary barriers to innovation, while continuing to protect health and the environment.
BIO is pleased that the Administration continues to reaffirm the principles of good regulation in the document on which comments are requested, Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology (Draft CF Update). If innovation is to flourish, then these principles, which were originally articulated in the 1986 Coordinated Framework and amplified in the 1992 “Federal Oversight” document, must continue to guide the agencies as they consider approaches to appropriate, science-based oversight of future biotechnology products.