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Biotechnology: OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology

Submitted by on October 7, 2015 – 1:00 pmNo Comment

(Bergeson & Campbell, PC)  On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA), and the development of a long-term strategy consistent with the objectives described in the July 2, 2015, memorandum jointly issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality directing EPA, FDA, and USDA to update the CF. In addition to the RFI, the update to the CF will undergo public comment before it is issued in final.

OSTP seeks answers to these questions:

  1. What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?
  2. What additional clarification could be provided regarding the roles that each agency plays for different biotechnology product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment?
  3. How can Federal agencies improve their communication to consumers, industry, and other stakeholders regarding the authorities, practices, and bases for decision-making used to ensure the safety of the products of biotechnology?
  4. Are there relevant data and information, including case studies, that can inform the update to the CF or the development of the long-term strategy regarding how to improve the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?
  5. Are there specific issues that should be addressed in the update of the CF or in the long-term strategy in order to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?

Commentary

As noted in our July 6, 2015, memorandum, Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology, the July 2 directive is an important if not urgently needed mandate to modernize the CF. It is important for stakeholders of all kinds — trade associations, innovators, and established businesses — to respond comprehensively to the questions asked, and comment on other issues even if not in response to the questions posed, which Question 5 seems to anticipate. Question 3 is among the most important, and perhaps the hardest to answer. Of course the federal government can improve its communication to stakeholders, but to do so, the various agencies in the biotechnology debate need to be able to define with clarity what their procedures, policies, and practices are. This is exactly what is unclear given some of the challenging jurisdictional issues that exist between and among federal agencies, and program offices within federal agencies.

Comments are due November 13, 2015.   READ MORE

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