ITIF Submission to the Office of Science & Technology Policy on "Building a 21st Century Bioeconomy"

December 6, 2011

Advances in life sciences are pivotal to the well-being of humankind and hold potentially vast economic benefits. In response to an Administration initiative to revise federal policies in this area, ITIF Senior Fellow Val Giddings urges policymakers to reform regulatory practices that are impeding the development of a sustainable, bio-based economy for the 21st century. In a submission filed with the Office of Science & Technology Policy (OSTP) he stresses regulations that do not address credible hazards must be retired, and regulatory oversight must be refocused on areas where risks might, in fact, reside and significant uncertainty remain. He outlined six specific steps for officials to take to ensure regulations better reflect the latest scientific data and promote the development and adoption of critical innovations in this area:

1) Reform the U.S. regulatory system. Regulations must be based in science and should be frequently updated to take into account the lessons gained from experience;

2) The trigger for regulatory review should be the novelty of the introduced trait (introduced by whatever method) and not the process used to introduce the trait;

3) Exempt phenotypes from regulatory review if they could be accomplished through classical breeding methods;

4) Regulatory agencies must stop treating gene flow as intrinsically hazardous, and shift their focus to appropriate risk management/mitigation in the rare cases where genes so disseminated could, in fact, present a genuine hazard;

5) Shift to phenotype-based regulatory triggers. Agencies should transition from an event-based regulatory process to a phenotype-based process, as the hazard of a phenotype that is stably inherited has more to do with the distinguishing features of the phenotype than with the precise details of the process through which it was produced;

6) Enhance effectiveness, adaptability, and public confidence by accelerating regulatory updates and transparency.