Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology," releasing two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to 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 proposed Update to the Coordinated Framework updates the 1986 Coordinated Framework for the Regulation of Biotechnology and provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to the regulation of biotechnology products. The National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) sets forth a long-term strategy intended to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology. The availability of the proposed Update to the Coordinated Framework will be announced in a Federal Register notice scheduled to be published on September 22, 2016, and comments will be due on November 1, 2016, at 5:00 p.m. (EDT).

Background

As reported in our July 6, 2015, memorandum, "White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology," on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum directs the federal agencies to develop a long-term strategy to ensure that the regulatory system for biotechnology products is prepared for future products, and commissions an expert analysis of the future landscape of biotechnology products. On October 6, 2015, OSTP issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology. More information on the RFI is available in our October 6, 2015, memorandum, "OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology." The Administration also held three public engagement sessions:

• October 30, 2015, as reported in our November 1, 2015, memorandum, "Public Meeting Announced To Discuss Modernizing The Regulatory System For Biotechnology Products Memorandum";
   
• March 9, 2016; and
   
• March 30, 2016.

Update to the Coordinated Framework

The White House states that the proposed Update to the Coordinated Framework "offers 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." To help product developers and the public understand what the regulatory pathway for biotechnology products might look like, the proposed Update 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.

According to the White House, this "comprehensive set of information" should give the public the confidence that biotechnology products that make it to market have been appropriately reviewed for safety.

The Administration seeks public comment on the proposed Update to the Coordinated Framework, and will prepare it in final after taking into account comments received. Once the notice of request for public comment has posted in the Federal Register (scheduled to be published on September 22, 2016), comments will be due on November 1, 2016, at 5:00 p.m. (EDT). The notice will be posted in the online docket.

National Strategy

According to the White House, the National Strategy 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 National Strategy, the federal agencies demonstrate their sustained commitment to ensuring the safety of future biotechnology products, increasing public confidence in the regulatory system, and preventing unnecessary barriers to future innovation and competitiveness.

The National Strategy highlights many existing and new activities at EPA, FDA, and USDA, including the following key commitments:

• 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 are emphasizing their commitments to interagency communication and collaboration to make timely decisions on regulatory jurisdiction for biotechnology products and to optimize the review and use of scientific data for regulatory assessments;
   
• EPA and FDA intend to clarify their respective approaches for oversight of products developed using genome editing techniques, including, for example, pesticidal products at EPA and genetically engineered animals at FDA;
   
• EPA, FDA, and USDA will continue to examine their regulatory structures with the goal of clarifying how the federal government will regulate genetically engineered insects in an integrated and coordinated fashion to cover the full range of potential products;
   
• EPA, FDA, and USDA commit to reporting annually, for at least the next five years, on specific steps that they are taking to implement the National Strategy, as well as any additional actions being taken to improve the transparency, predictability, and efficiency of biotechnology regulation and the coordination among the regulatory agencies;
   
• EPA, FDA, and USDA will continue to provide leadership in international fora to promote scientific competency, understanding of the U.S. regulatory approach, and regulatory compatibility worldwide for biotechnology products; and
   
• EPA, FDA, and USDA commissioned a study by the National Academies of Science, Engineering, and Medicine (NAS) entitled "Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System." The forthcoming report will be used by EPA, FDA, and USDA to inform ongoing and future agency activities.

More information on the NAS study is available in our March 18, 2016, memorandum, "NAS to Study Future Products of Biotechnology."

Commentary

In its blog post, the White House acknowledges that while the proposed Update to the Coordinated Framework and the National Strategy represent major steps forward in modernizing the regulatory system for biotechnology products, there is more work to be done. While prefacing its overview with the statement that the current federal regulatory system effectively protects health and the environment, advances in science and technology necessitate change. In the National Strategy, EPA, FDA, and USDA identified areas where additional work is needed, including the key commitments listed above. The White House states that these ongoing and future activities, along with the commitment from the agencies to report annually on implementation progress, provide direction for the federal regulatory system for biotechnology products to keep pace with advances in science and technology.

The Update represents a useful first step in a process that urgently needs to continue into the next Administration. The work to date nicely lays out a blueprint for action that stakeholders can only hope will be a priority for the next Administration. The White House seeks continued engagement from key stakeholders, including public and private organizations such as companies, universities and research institutes, trade associations, scientific societies, foundations, consumer organizations, non-profits, and individual citizens.