National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies

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March 14, 2017

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(Bergeson & Campbell) On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee). The Committee was asked to describe the possible future products of biotechnology that will arise over the next five to ten years, as well as provide some insights that can help shape the capabilities within the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) as they move forward. According to the Committee, agencies may be overwhelmed by the number and diversity of new biotechnology products. The Committee states that the agencies should increase their scientific capabilities, tools, and expertise in key areas of expected growth. The report reflects the Committee’s deliberations regarding the future products of biotechnology that are likely to appear on the horizon, the challenges that the regulatory agencies might face, and the opportunities for enhancing the regulatory system to prepare for what might be coming. The Committee reached consensus on conclusions and recommendations that are based on extensive information gathering, Committee discussions, and input from a wide variety of communities interested in biotechnology. A copy of the slides used during a National Academies webinar on the report can be found on the National Academies’ website.

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As reported in our January 9, 2017, memorandum, “White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology,” 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 EPA, FDA, and 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.”

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Future Biotechnology Products

The Committee grouped future products into three major classes:

Open-release products: The open-release products that the Committee saw on the horizon include plants, animals, microbes, and synthetic organisms that have been engineered for deliberate release in an open environment. According to the report, the ability to sustain existence in the environment with little or no human intervention is a key change between existing products of biotechnology and some of the future ones anticipated in this class. The report states that the Committee thought that future open-release products would be developed for familiar uses, such as agricultural crops, but would also likely be developed for uses such as cleaning up contaminated sites with engineered microbes, replacing animal-derived meat with meat cultured from animal cells, and controlling invasive species through gene drives;
Contained products: The Committee concluded that future biotechnology products that are produced in contained environments are more likely to be microbial based or synthetically based rather than based on an animal or plant host. According to the report, organisms of many genera are used in fermenters to produce commodity chemicals, fuels, specialty chemicals or intermediates, enzymes, polymers, food additives, and flavors. When considering the laboratory as a contained environment, the report states that many examples of transgenic animals from vendors are widely used today for research and development. Because performing biotechnology in contained environments allows higher control over the choice of host organism, systems with advanced molecular toolboxes are already in high use; and
Platforms: Biotechnology platforms are tools that are used in the creation of other biotechnology products, according to the report, including products that are traditionally characterized as “wet lab,” such as DNA/RNA, enzymes, vectors, cloning kits, cells, library prep kits, and sequencing prep kits, and products that are “dry lab,” such as vector drawing software, computer-aided design software, primer calculation software, and informatics tools. The report states that these two categories continue to meld as newer approaches are published or commercialized. READ MORE