In 1986, the White House Office of Science and Technology Policy (OSTP) issued the Coordinated Framework for the Regulation of Biotechnology, which outlined a comprehensive Federal regulatory policy for ensuring the safety of biotechnology products. The Framework was updated in 1992.  While the current regulatory system for biotechnology products effectively protects health and the environment, advances in science and technology since 1992 have been altering the product landscape.  In addition, the complexity of the array of regulations and guidance documents developed by the three Federal agencies with jurisdiction over biotechnology products can make it difficult for the public to understand how the safety of biotechnology products is evaluated, and navigating the regulatory process for these products can be unduly challenging, especially for small companies.

These circumstances call for revisiting the Coordinated Framework once more.  Accordingly, today the White House is issuing a memorandum directing the three Federal agencies that...