In 2015, the Executive Office of the President (EOP) issued a memorandum directing EPA, FDA, and USDA to update the Coordinated Framework to clarify current roles and responsibilities of the agencies that regulate biotechnology products; develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology; and commission an independent, expert analysis of the future landscape of biotechnology products. As part of this effort, the agencies hosted three public meetings and received public input both at the meetings and through an open public docket.
The goal of this work was to increase public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.
2017 Update to the Coordinated Frame
The 2017 Update to the Coordinated Framework for the Regulation of Biotechnology was published in January 2017. A sequel to the 1986 CF and the 1992 Update to the CF, it clarifies the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products. It describes the types of biotechnology product areas regulated by each primary regulatory agency (i.e., EPA, FDA, or USDA). The document provides a table of responsibilities, organized by biotechnology product area, describing the offices within each agency or agencies that may have regulatory responsibility for a given biotechnology product area, as well as relevant coordination across the agencies. In addition, the document describes mechanisms for communication across the agencies, including memoranda of understanding (MOU) and the types of products and information that are covered within the scope of each MOU.
The National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, 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. It identifies steps to ensure that the regulatory system appropriately addresses novel types of products developed through advances in science and technology. In this document, EPA, FDA, and USDA identified specific ongoing and future activities aimed at increasing transparency, increasing predictability and efficiency, and supporting the science that underpins the regulatory system.
FDA (in some cases, in conjunction with EPA and USDA) has initiated activities described in the Strategy to modernize the regulatory system for biotechnology products.
Future Products of Biotechnology Study
EPA, FDA, and USDA commissioned an independent study by the National Academies of Science, Engineering, and Medicine (NASEM) to satisfy the third of the three tasks. The NASEM Committee was tasked to identify(1) major advances and potential new types of biotechnology products over the next five to ten years, (2) potential future products that might pose a different type of risk relative to existing products and organisms,(3) areas in which the risks or lack of risk relating to biotechnology are well understood, and (4) the scientific capabilities, tools, and expertise that may be useful to the regulatory agencies as they oversee potential future products of biotechnology. In March 2017, NASEM issued the study report, “Preparing for Future Products of Biotechnology.”