Improving Transparency and Ensuring Continued Safety in Biotechnology

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 have oversight responsibilities for these products—the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA)— to 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.

Increasing transparency & predictability in biotechnology regulation

The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system.  Here is a bit more detail about the effort’s three components:

• First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
• Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
• Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis. 

More details on the elements of each of these components can be found in the memo to agencies that was issued today.

We want to hear from you

The Administration recognizes the importance of public engagement throughout this process. As part of this process, 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. If you would like to be kept up to date on these activities, including details on the listening sessions, please sign up here.

John P. Holdren is Assistant to the President for Science and Technology and Director of the White House Office of Science and Technology Policy.

Howard Shelanski is Administrator of the Office of Information and Regulatory Affairs at the Office of Management and Budget

Darci Vetter is Chief Agricultural Negotiator at the Office of the United States Trade Representative

Christy Goldfuss is Managing Director of the White House Council on Environmental Quality