On July 2, 2015, the U.S. Office of Science and Technology Policy (OSTP) of the Office of the President issued a memorandum to initiate a process to coordinate, update and modernize the federal regulatory system governing biotechnology products. The process outlined in the OSTP memo will impact the way the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA) and other agencies regulate biotechnology products. The OSTP initially issued a Coordinated Framework (CF) for Regulation of Biotechnology in 1986 and updated the CF in 1992. The 1986 CF laid the foundation for a coordinated effort among agencies to balance regulation with innovation, while the updated 1992 CF took a risk-based approach to regulation, focusing on the environmental and ecological aspects of introducing biotechnology products into the environment (rather than the manufacturing process).
Since the 1992 update, substantial advances in biotechnology, including the progression of recombinant DNA technology and development of synthetic biology techniques, have necessitated additional regulation. Such regulations, however, have led to uncertainty in agency jurisdiction and lack of predictability, creating unnecessary costs and inhibiting innovation. The OSTP aims to correct these problems with the process outlined in the memorandum. Notably, the memorandum focuses on biotechnology products, including products developed and produced through genetic engineering or in vitro manipulation, but not human drugs or medical devices.
Numerous federal acts govern the introduction of products, including biotechnology products, into the environment. The Federal Plant Pest Act governs the importation and movement of plant pests; the Federal Food, Drug and Cosmetic Act (FFDCA) governs foods, food additives, cosmetics, human and veterinary drugs, and medical devices; the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) governs pesticides; and the Toxic Substances Control Act (TSCA) governs chemical agents. These statutes authorize federal agencies to promulgate regulations and oversee the development of biotechnology products. For instance, the EPA regulates a microbial pesticide under the FIFRA. Meanwhile, APHIS may regulate pesticides used in plants and the FDA may regulate and determine the pesticide toxicity levels in edible plants. Although agency jurisdiction over a biotechnology product is determined by the product’s use, the varied uses and chemical and biological nature of biotechnology products often lead to uncertainty in jurisdiction and unpredictability, which in turn leads to over-regulation and unnecessary costs.
Summary of Process
The OSTP memorandum delineates the following three one-year objectives: (1) development of an updated CF to clarify agencies’ roles, (2) formulation of a long-term strategy to assess risks associated with future products and (3) commissioning an independent analysis for the future of biotechnology products. To achieve these objectives, the OSTP created a new committee comprising representatives from the Executive Office, EPA, FDA and USDA. The committee must update the CF to define the roles and areas within the authority of each agency and develop a long-term regulatory strategy to efficiently assess the risks associated with biotechnology products while supporting innovation.
In addition, the EPA, FDA and USDA will commission the National Academies of Sciences, Engineering, and Medicine – private, nonprofit institutions that provide expert advice to help shape sound policies, inform public opinion, and advance the pursuit of science, engineering, and medicine – to conduct an independent analysis of the future landscape of biotechnology products.
The public may provide comments on the CF and partake in the process. The OSTP will hold three public engagement sessions this year, and the updated CF will undergo notice and comment prior to being finalized.
The agencies will address current regulatory processes that overlap, create ambiguities, and unnecessarily increase costs, inhibiting innovation. By correcting these processes, companies should be able to better predict the regulatory pathway for products to reach market, reducing risks and incentivizing investment. In addition, this correction will inevitably alter the current landscape of regulations. Companies should assess how this change will impact compliance, development and production. Moreover, companies, in particular biotechnology companies impacted by overlapping regulatory processes, should consider retaining counsel and participating in the public engagement and providing comments concerning the CF. In this regard, companies should identify regulatory hurdles caused under the current system, including any unpredictable or unnecessary regulations.
The agencies will also identify future biotechnology products such as synthetic biologics that may present regulatory hurdles or require additional regulation. Companies should evaluate how the current regulatory landscape could be improved or how it should not be altered to affect future products. This evaluation will enable companies to provide meaningful comments to sculpt future regulations of biotechnology products.