The White House plans to again update the Coordinated Framework for the Regulation of Biotechnology in the U.S. to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system.
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.
The office said that since the update in 1992, advances in science and technology have been altering the product landscape and 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. Navigating the regulations is challenging especially for small companies, it also noted.
The OSTP has sent a memorandum to the three federal agencies that have oversight responsibilities for biotech products—the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA)—update the Coordinated Framework, develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort.
The administration will hold three public engagement sessions over the year in different regions of the country. The first listening session will occur in Washington, D.C. in fall 2015. In addition, the update to the Coordinated Framework will undergo public notice and comment before it is finalized. To stay up to date on these activities, including details on the listening sessions, sign up here.