On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers 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.” More information is available in the White House blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System.”
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. The Obama Administration asked EPA, FDA, and 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 assess efficiently the risks, if any, of the future products of biotechnology; and
- Commission an expert analysis of the future landscape of biotechnology products.
More information regarding the July 2, 2015, memorandum is available in our July 6, 2015, memorandum, “White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.”
As reported 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,” 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. The RFI was intended to assist OSTP in clarifying the current roles and responsibilities of EPA, FDA, and USDA, and the development of a long-term strategy consistent with the objectives described in the July 2, 2015, memorandum. Three public meetings were held to solicit comment on the current federal roles and responsibilities regarding biotechnology products. More information regarding the meetings is available in our November 1, 2015, memorandum, “Public Meeting Announced To Discuss Modernizing The Regulatory System For Biotechnology Products Memorandum,” and our February 29, 2016, memorandum, “Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9.”
On September 16, 2016, the White House released a proposed Update to the Coordinated Framework, as well as the National Strategy. As reported in our September 21, 2016, memorandum, “White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products,” 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.
2017 Update to the Coordinated Framework
The 2017 Update is intended to clarify the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products. The accompanying National Strategy, published in September 2016, identifies future steps intended to ensure the regulatory system addresses novel types of products developed through advances in science and technology appropriately.
Principles for the Regulation of the Products of Biotechnology
The Update to the Coordinated Framework lists principles drawn from the 1986 Coordinated Framework, the 1992 Update to the Coordinated Framework, Executive Orders 13563 and 13610, the 2011 Principles for Regulation and Oversight of Emerging Technologies memorandum, and the July 2015 memorandum. According to the Update to the Coordinated Framework, the following principles “continue to serve as guidance for the primary regulatory agencies that help ensure the safety of biotechnology products”:
- Federal statutes and implementing regulations regulate products based on specific uses. This approach means that products with the same use are subject to the same types of oversight by the relevant regulatory agencies;
- Biotechnology products have applications in many areas, such as medicine, agriculture, energy, manufacturing, and environmental protection;
- The intended introduction of biotechnology products into the environment can be subject to federal oversight under federal statute(s) related to such products and their intended application;
- Each agency uses its existing statutory authorities and regulations to ensure the safety of the biotechnology products for their intended applications;
- Underlying statutes define the boundaries of the scope of oversight afforded to each regulatory agency;
- It is the characteristics of the biotechnology product, the environment into which it will be introduced, and the application of the product that determine its risk (or lack thereof);
- Exercise of agency oversight within the scope afforded by statutes should be commensurate with the risk posed by the introduction of the biotechnology product and should not turn on the fact that it was created or has been altered by a particular process or technique;
- To the extent permitted under relevant statutory provisions, following a risk-based approach to regulation, the regulatory system should distinguish between those biotechnology products that require a certain level of federal oversight and those that do not;
- Because the overarching U.S. regulatory framework for biotechnology products relies on several different existing federal laws, statutory nomenclature for certain actions may seem inconsistent; notwithstanding those seeming inconsistencies, the reviews conducted by each of the regulatory agencies are intended to be of comparable rigor to the extent allowed by law;
- The agencies endeavor to operate their programs in an integrated and coordinated fashion; together, they should cover the full range of plants, animals, and microorganisms derived from biotechnology; and
- Future scientific developments will lead to further refinements of the Coordinated Framework. Experience with earlier basic scientific research has shown that as science progresses, regulatory regimens can be modified to reflect a more complete understanding of the potential risks involved. Refinements to the Coordinated Framework should consider any such updates to regulatory processes.
Roles and Responsibilities of the Primary Agencies that Regulate the Products of Biotechnology
To clarify which biotechnology product areas are within the authority and responsibility of each agency, the 2017 Update describes the types of biotechnology product areas regulated by the various components within each primary regulatory agency (i.e., EPA, FDA, or USDA), organized by agency. The 2017 Update provides an overview of the statutory authorities used by each agency and the health and environmental protection goals each agency derives from those authorities (organized by agency); identifies the product areas that fall within the statutory authorities and responsibilities of each agency (organized by agency); and summarizes the role each agency plays in the regulation of biotechnology products (organized by product category). The 2017 Update notes that the specific regulatory path (and relevant procedures) applicable to any product, including a biotechnology product, is dependent on the nature and characteristics of the product and its application. The 2017 Update includes Table 1 that summarizes the statutes and protection goals related to EPA, FDA, and USDA for the regulation of biotechnology products:
|EPA||Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)||Prevent and eliminate unreasonable adverse effects on the environment
|Federal Food, Drug, and Cosmetic (FD&C) Act||Ensure that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.|
|Toxic Substance Control Act (TSCA)||Prevent the manufacture, processing, distribution in commerce, use, or disposal of chemical substances, or any combination of such activities with such substances, from presenting an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible population, without consideration of costs or other nonrisk factors.|
|FDA||FD&C Act||Ensure human and animal food is safe, sanitary, and properly labeled.
Ensure human and animal drugs are safe and effective.
Ensure the reasonable assurance of the safety and effectiveness of devices intended for human use.Ensure cosmetics are safe and properly labeled.
|Public Health Service (PHS) Act||Ensure the safety, purity, and potency of biological products.|
|USDA||Animal Health Protection Act (AHPA)||Protect livestock from animal pest and disease risks.|
|Plant Protection Act (PPA)||Protect agricultural plants and agriculturally important natural resources from damage caused by organisms that pose plant pest or noxious weed risks.|
|Federal Meat Inspection Act (FMIA)||Ensure that the U.S.’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled.|
|Poultry Products Inspection Act (PPIA)||Ensure that the U.S.’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled.|
|Egg Products Inspection Act (EPIA)||Ensure that the United States' commercial supply of meat, poulty, and egg products is safe, wholesome, and correctly labeled.|
|Virus-Serum-Toxin Act (VSTA)||Ensure that veterinary biologics are pure, safe, potent and effective.|
The 2017 Update to the Coordinated Framework clarifies the roles each agency plays for different product areas, particularly for those products that fall within the scope of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment by providing a table of responsibilities, organized by biotechnology product area. Table 2 of the 2017 Update describes 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.
Interagency Communication and Coordination
The 2017 Update clarifies the mechanisms currently in place that enable communication and sharing of information, as appropriate and necessary, among EPA, FDA, and USDA. According to the 2017 Update, these mechanisms are “particularly helpful with respect to regulation of products that fall under the purview of more than one agency or may necessitate close coordination prior to decision making.” The mechanisms reviewed include formal and ad hoc interagency working groups and memoranda of understanding.
Future Reviews of and Updates to the Coordinated Framework
To clarify the mechanism and timeline for regularly reviewing and updating the Coordinated Framework, the 2017 Update discusses provisions for future review of the Coordinated Framework. For at least five years, beginning in 2017, the Biotechnology Working Group, which was created by the July 2015 memorandum, will produce an annual report on specific steps that agencies are taking to implement the National Strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products. According to the 2017 Update, the annual report will be made available to the public. The 2017 Update states that at the end of this work, the Biotechnology Working Group is expected to continue monitoring scientific and technical developments in biotechnology and its applications, and to work with stakeholders to undertake future updates to the Coordinated Framework as warranted.
Clarifying Roles and Responsibilities through Case Studies
The 2017 Update includes case studies that are intended to provide general information to developers who believe they have, or are uncertain as to whether they may have, a biotechnology product that is subject to regulation under one or more of the federal laws described in the Coordinated Framework. The 2017 Update uses case studies as a means of demonstrating how a developer might navigate the regulatory framework, starting from research activities in the laboratory, to full commercialization of the product. Certain products may also have post-market monitoring and reporting requirements. The case studies of hypothetical genetically engineered organisms include: corn with pesticidal properties; a rose plant with increased pigment production in its petals; plant pest and non-plant pest microbial pesticides; a rabbit producing a recombinant insulin for treatment of humans; and algae for biofuel production. The individual regulatory path that a product takes is based on its characteristics and application, as one or both can affect the regulatory status and relevant requirements established in the various regulations that underlie the Coordinated Framework. Recognizing that intricacies exist in any regulatory system, the 2017 Update states that EPA, FDA, and USDA “welcome and encourage developers of biotechnology products to contact the agencies at the early stages of product discovery or development so any questions related to regulatory status, safety, and/or effectiveness can be identified and adequately addressed.” According to the 2017 Update, “[c]ontacting agencies at the early stages of product development may make the regulatory process more predictable for applicants.”
The 2017 Update represents a thoughtful and very useful step in clarifying the roles participating federal agencies play in the commercialization of products of biotechnology. The Obama Administration is to be commended for its swift and comprehensive updating of the Coordinated Framework. The final version of the Framework helps clarify the often daunting regulatory process innovators and others in the area face when they create new biotech products and wish to commercialize them. At the same time, we must object to the description of EPA’s authorities under new TSCA regarding new chemicals. While we appreciate the difficulties of capsulizing legal language, particularly for use in Table 1, we would have preferred an approach in the report text (see unit D.1.c.) that went beyond the Table 1 capsule and clarified the meaning by including the critical concept that regulatory actions are to be taken to “the extent necessary to protect against” such risk.
EPA, FDA, and USDA commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products that will be forthcoming and will provide an opportunity for 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. Stakeholders should support the NAS review and urge the new Administration to carry on this essential work to ensure the next generation of biotechnology products is the result of a modernized and efficient regulatory system.