On Revision of the Coordinated Framework for the Regulation of Biotechnology

March 22, 2016

This white paper provides responses to questions posed in the October 2015 request for comment on revision of the Coordinated Framework and offers recommendations on long term strategies to foster innovation while addressing potential risks. It divides into three sections.

Priority regulatory issues: This section treats issues of immediate concern, as defined by five questions posed in the October 2015 request for public comment on updating the Coordinated Framework. For each question, we provide a distillation of issues raised in public comments, highlight gaps in discussion to date, point to useful resources, and offer recommendations.

Long term strategies for responsible innovation: This section responds to Part II of the July 2015 memorandum on the scope of inquiry for review of U.S. biotechnology policy. We recommend a strategy of planned adaptation, with research designed to provide a scientific basis for public policy and with tools, procedures and schedules to foster systematic reevaluation of policies in light of changing understandings of benefits, risks, and social/economic context.

Appendix with Analysis of Public Comments: This section provides a more complete analysis of public comments by industry, the academy and civil society.

Access the paper here