In July 2015, the Office of Science and Technology Policy in the Executive Office of the President initiated an effort to modernize the U.S. regulatory system for biotechnology productsconsisting of three primary activities:1. Development of an update to the Coordinated Framework for Regulation of Biotechnology(referred to hereafter as the Coordinated Framework) to clarify the roles and responsibilities of the agencies that regulate the products of biotechnology;2. Formulation of a long-term strategy to ensure that the federal regulatory system is equippedto efficiently assess the risks, if any, associated with future products of biotechnologywhile supporting innovation, protecting health and the environment, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducingunnecessary costs and burdens; and3. Commission of an external, independent analysis of the future landscape of biotechnologyproducts with a primary focus on potential new risks and risk-assessment frameworks.
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