On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a proposed update to the 1986 framework, intends to clarify the current roles of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) – the three primary agencies involved in the regulation of biotechnology products. Members of the regulated industry, other stakeholders, and members of the broader public may submit comments on the proposed update until November 1, 2016. The second document presents a national strategy outlining future steps that the Agencies intend to take to ensure that the regulatory system addresses novel biotechnology product types going forward. As directed by the Executive Office of the President last year, the Agencies have also commissioned development of a third document by the National Academies of Sciences, Engineering and Medicine (NAS) to address future biotechnology products and opportunities to enhance capabilities of the regulatory system. The NAS expects to release its report at the end of 2016.
Proposed Update to the Coordinated Framework
The proposed update to the Coordinated Framework represents the federal government’s first comprehensive overview of the regulatory landscape for biotechnology products in 30 years. The Agencies assure the public that the current regulatory system “effectively protects health and the environment.” They go on to observe the potential for unnecessary costs and burdens under the existing regulatory processes, particularly highlighting ongoing uncertainty over agency jurisdiction and the lack of predictable timeframes for review. The Agencies also recognize that advances in science and technology have “dramatically altered” the biotechnology landscape in recent years and, in that context, seek to clarify through the newly proposed update which biotechnology product areas are within the authority and responsibility of each Agency.
The document incorporates a number of tables, graphics, and several hypothetical case studies intended to help illustrate the role each Agency plays in biotechnology regulation and the different regulatory paths applicable to various product types. Specifically, the document outlines:
- EPA’s regulatory authority over chemical pesticides, microorganisms, biochemicals, and plant-incorporated protectants (PIPs) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and Federal Food, Drug and Cosmetic Act (FFDCA), and EPA’s oversight responsibilities for a wide range of microbial biotechnology applications under the Toxic Substances Control Act (TSCA);
- FDA’s regulation of human and animal food derived from (i) genetically engineered plants; (ii) genetically engineered animals; and (iii) human drugs, biologicals, and medical devices derived from genetically engineered sources under the FFDCA; and
- Regulation by USDA’s Animal and Plant Health Inspection Service (APHIS) of biotechnology products that may (i) introduce pests or cause disease to livestock under the Animal Health Protection Act (AHPA), (ii) be deemed plant pests or noxious weeds under the Plant Protection Act (PPA), or (iii) be used in veterinary biologics under the Virus-Serum-Toxin Act (VSTA); along with the role played by USDA’s Food Safety and Inspection Service (FSIS) in reviewing the safety of meat, poultry, eggs, or fish from genetically engineered animals intended for human consumption.
When preparing comments for submission on the proposed update, stakeholders should closely review the division of oversight and coordination in connection with the specific product areas outlined by the document’s summary table and consider whether and how additional clarifications or refinements may be warranted in this regard.
National Strategy for Modernizing the Regulatory System for Biotechnology Products
The Agencies’ separate strategy document reflects their joint effort to equip the federal regulatory system to efficiently assess any risk associated with future products of biotechnology. To this end, the goals described in the strategy document include:
- increasing transparency (through, for example, work with stakeholders to identify impediments to innovation, streamline processes, and reduce costs and response times);
- increasing predictability and efficiency (including development of a plan for periodic assessments of new biotechnology products, ensuring that product evaluations are risk-based and grounded in the best available science, and identifying regulatory and policy changes that may improve expeditious risk assessments); and
- supporting the science that underpins the regulatory system (through development of a coordinated plan to support the science that informs biotechnology product assessments).
Notably, the new strategy encourages product developers who are uncertain about relevant regulatory requirements to reach out to the Agencies early in the product development process, while highlighting a number of existing mechanisms intended to help stakeholders navigate the regulatory system (including public meetings, workshops, website queries, and available guidance documents). The Agencies also indicate their intention to review existing communication tools and potentially revise or develop new sources of information for developers and the public. As examples of current efforts to increase predictability and efficiency, the Agencies specifically highlight EPA’s recent proposal to modify its approach to PIPs in breeding line intermediates (BLIs) and USDA’s efforts to revise its regulation of genetically engineered plant pest organisms at 7 CFR Part 340.
Looking ahead, the Agencies further indicate that they are working to “better align” their responsibilities over genetically engineered mosquitoes and other insects with their traditional oversight roles, and more broadly to enhance interagency collaborations in order to optimize the review and use of data and assessments. Finally, the strategy document identifies actions underway at the individual Agencies and relevant to the biotechnology regulatory framework, including EPA’s staff reorganization, which will centralize review and regulation of PIPs into one group; EPA’s plans to modify its approach to transformation events in product identification; intentions by EPA and FDA to each clarify their respective approaches to products derived from genome-editing techniques; and FDA’s consideration of updates to its 1996 guidance on consultation procedures for food derived from new plant varieties.