Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System

In 2015, the Administration initiated an effort to modernize the regulatory system for biotechnology products by asking the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the United States Department of Agriculture (USDA) to accomplish three tasks:

• clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
• 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.

Learn about this effort on the White House website here, here, and here or by visiting EPA, FDA, and USDA.

Clarifying current roles and responsibilities

Today’s release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology represents the first time in 30 years that the Federal government has produced a comprehensive summary of the roles and responsibilities of the three principal regulatory agencies with respect to regulating biotechnology products. This update and the accompanying National Strategy for Modernizing the Regulatory System for Biotechnology Products (Strategy) offer the public a complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology. Within that regulatory structure the Federal agencies maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices. This update was completed after reviewing the public comments submitted in response to the proposed Update to the Coordinated Framework that was released on September 22, 2016. A brief summary of those comments, along with additional information that addresses the comments that asked for clarification on current regulation of biotechnology products, is included in the final version released today.

In order to help product developers and the public understand what the regulatory pathway for products might look like, this 2017 Update to the Coordinated Framework presents information about agency roles and responsibilities in several forms, including:

• graphics that illustrate agency-specific overviews of regulatory roles;
• case studies that demonstrate how a product developer might navigate the regulatory framework, and;
• a comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

The long-term strategy

The Strategy, which was released in September 2016, sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens. In the Strategy, the Federal agencies demonstrate their sustained commitment to ensure the safety of future products of biotechnology, increase public confidence in the regulatory system, and prevent unnecessary barriers to future innovation and competitiveness.

The future landscape of biotechnology products

Early in 2016, EPA, FDA, and USDA commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products. The study, which is ongoing, will 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.

Moving forward

While today’s release of the of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology represents remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains. The findings by the NAS report on future biotechnology products, along with the comments submitted in response to the proposed Update to the Coordinated Framework and information gathered during the three public engagement sessions that EPA, FDA, and USDA hosted in 2016, will be considered by these agencies in order to inform ongoing and future agency activities.

Moving forward, EPA, FDA, and USDA will continue to fulfill the goals identified in the Strategy and these agencies look forward to continued engagement from key stakeholders, such as companies, universities and research institutes, trade associations, scientific societies, foundations, consumer organizations, non-profits, and individual citizens.

Robbie Barbero is Assistant Director for Biological Innovation at the White House Office of Science and Technology Policy.

Ted Boling is the Associate Director for the National Environmental Policy Act at the White House Council on Environmental Quality

Julia Doherty is the Senior Director, Agricultural and SPS Affairs in the Office of the U.S. Trade Representative.

James Kim is a toxicologist in the Office of Information and Regulatory Affairs at the Office of Management and Budget.