Regulatory Guidance

Regulatory Guidance

As we consider biotechnology regulation, we are guided by the March 11, 2011 memo to Executive Agencies on the Principles for Regulation and Oversight of Emerging Technologies issued by the Executive Office of the President, which states in part that:

We share a fundamental desire for regulation and oversight that ensure the fulfillment of legitimate objectives such as the protection of safety, health, and the environment. Regulation and oversight should avoid unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers.

In addition, we are guided by Executive Order 13563 - Improving Regulations and Regulatory Review, which states in part that:

Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness,  and job creation. It must be based on the best available science. It must allow for public participation and an open exchange of ideas. It must promote predictability and reduce uncertainty. It must identify and use the best, most innovation and least burdensome tools for achieving regulatory ends. It must take into account benefits and costs, both quantitative and qualitative. It must ensure that regulations are accessible, consistent, written in plain language,   and easy to understand. It must measure, and seek to improve, the actual results of regulatory requirements.

 

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