Modernizing the Regulatory System for Biotechnology Products
In an ongoing effort to modernize the regulatory system for products of biotechnology, the Executive Office of the President, along with the FDA, the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA), has released the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. This final update was completed after reviewing public comments submitted in response to the Proposed Update to the Coordinated Framework, released on September 22, 2016.
The policy of the United States Government is to seek regulatory approaches that protect health and the environment, while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers. To this end, the White House Office of Science and Technology Policy (OSTP) issued in 1986 the Coordinated Framework for the Regulation of Biotechnology (the Coordinated Framework), which sought to achieve a balance between regulation adequate to ensure the protection of health and the environment while maintaining sufficient regulatory flexibility to avoid impeding innovation. OSTP issued its first update of the Coordinated Framework in 1992.
The 2017 Update to the Coordinated Framework and the National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy; released in September 2016) represent two of three key activities outlined in a July 2, 2015 memorandum from the Administration directing FDA, EPA, and USDA— the primary agencies that regulate the products of biotechnology—to accomplish three tasks:
- update the Coordinated Framework by clarifying current roles and responsibilities;
- develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
- commission an expert analysis of the future landscape of biotechnology products to support this effort.
This work is intended to provide more clarity about the way these agencies regulate biotechnology products to protect health and the environment while preventing unnecessary barriers to future innovation and competitiveness and enhancing the transparency, predictability, and efficiency of the regulation of biotechnology products.
In developing these documents, FDA, along with OSTP, EPA, and USDA, reviewed all written comments received in response to a previous notice of request for information, comments received at three public meetings, and comments in response to the Proposed Update to the Coordinated Framework.
The 2017 Update to the Coordinated Framework describes the current statutory authorities and regulatory programs EPA, FDA, and USDA use to help ensure the safety and, where applicable, the effectiveness of biotechnology products. In addition, the agencies clarify their current oversight roles and responsibilities and relevant coordination across EPA, FDA, and USDA.
The Strategy sets forth a vision for ensuring that the Federal regulatory system is prepared to efficiently assess the risks, if any, of the future products of biotechnology. The Strategy focuses on increasing the transparency, predictability, and efficiency of the regulatory process, and supporting the science that underpins the regulatory system.
As described in the Strategy, FDA (in some cases, working with EPA and USDA) commits to various activities, including the following:
- EPA, FDA, and USDA will review existing communication tools and, as appropriate, may revise existing or develop new user-friendly sources of regulatory information for product developers and the general public.
- EPA, FDA, and USDA have commissioned an independent study by the National Academy of Sciences (NAS) titled, "Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System,” and will consider the findings of this study to inform ongoing and future activities, including implementation of the Strategy.
- FDA intends to explore updating guidance regarding the consultation procedures for food derived from new plant varieties.
- EPA, FDA, and USDA will continue to examine their regulatory structures with the goal of clarifying how the U.S. Federal Government will regulate genetically engineered insects in an integrated and coordinated fashion.
- FDA intends to clarify its policy for the regulation of products derived from genome editing techniques, including, as appropriate, identifying and/or updating relevant existing guidance documents.
- FDA’s Emerging Sciences Working Group will be used to identify science and technology trends of relevance to FDA’s regulatory responsibilities, including those for biotechnology products.
- EPA, FDA, and USDA will continue to explore mechanisms to enhance coordination with federal research agencies to help support agencies’ regulatory science needs.
- EPA, FDA, and USDA emphasize their commitments to interagency communication and collaboration in order to make timely decisions on regulatory jurisdiction for biotechnology products and to optimize the review and use of scientific data for regulatory assessments.
- As instructed in the July 2015 EOP memorandum, for at least five years, starting one year after the release of the Strategy, EPA, FDA, and USDA expect to produce an annual report on the specific steps the agencies are taking to implement the Strategy.
Moving forward, FDA, in collaboration with EPA and USDA, will continue the work initiated to fulfill the goals identified in the Strategy.
For more information
- FDA’s Role in Regulating the Safety of Foods from GE Plants
- FDA’s Regulatory Process Related to GE Animals
- Blog: Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System