Preparing for Future Products of Biotechnology (2017) / Chapter Skim
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Formulation of a long-term strategy to ensure that the federal regulatory system is equipped to efficiently assess the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, promoting public con fidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens; and 3. Commission of an external, independent analysis of the future landscape of biotechnology products with a primary focus on potential new risks and risk-assessment frameworks.
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It also solicited statements from members of the public at its in-person meetings and accepted written comments through the duration of the study. The committee also made use of several recent National Academies studies related to future products of biotechnology, particularly Industrialization of Biology: A Roadmap to Accelerate the Advanced Manufacturing of Chemicals,2 Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values,3 and Genetically Engineered Crops: Experiences and 2NRC (National Research Council)
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FUTURE BIOTECHNOLOGY PRODUCTS The committee was charged to describe biotechnology products likely to emerge in the next 5–10 years. The committee scanned the horizon for new products by inviting product developers to speak at the various meetings; reviewing submitted public comments; reading scientific literature, popular press reports, and patents; consulting previous reports by the National Academies; searching publicly available projects developed by international Genetically Engineered Machine teams;5 and checking information available on regulatory agencies' websites and crowdfunding websites.
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ü ü Animal Products Animals and Reduced-allergen goat's milk ü Landmine-detecting mice ü Animals revived from near extinction or extinction ü Animals with gene drives for control of invasive ü mammals Animals with gene drives for control of insect ü pests Biosensors/bioreporters ü Microbial Products Bioremediation ü Microbes and Engineered algal strains üüü Nitrogen-fixing symbionts ü Probiotics ü Genomically engineered microbial communities üüü Biomining/bioleaching üüü Cell-free products ü Nucleic Acids Organisms/ Synthetic DNA barcodes to track products ü ü RNA-based spray for insect-pest control ü Genomically recoded organisms ü Biological/mechanical hybrid biosensors ü ü üüü = an area the committee has identified as having high growth potential. aThe table reflects the market status of products at the time the committee was writing the report.
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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. Biotechnology platforms are tools that are used in the creation of other biotechnology products.
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Despite the flexibility of the Coordinated Framework to cover a wide range of biotechnology products, the committee also found that the existing biotechnology regulatory system is complex and could be considered to appear fragmented, resulting in a system that is difficult for product developers -- including individuals, nontraditional organizations, and small enterprises -- as well as consumers, product users, and interested members of the public to navigate. This complexity can cause uncertainty and a lack of predictability for developers of future biotechnology products and creates the potential for loss of public confidence in oversight of future biotechnology products.
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Such products may have few or no comparators8 to existing nonbiotechnology products, which function as the baseline of comparison in current regulatory risk assessments of biotechnology products. Figure S-1 summarizes the progression in terms of complexity and novelty that the committee thought was likely in future biotechnology products over the next 5–10 years.
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OPPORTUNITIES FOR ENHANCEMENT OF THE BIOTECHNOLOGY REGULATORY SYSTEM A major task of the committee was to indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of future products of biotechnology. The committee requested information from federal agencies regarding current investments in regulatory science.9 At a high level, the committee found that there are existing frameworks, tools, and processes for risk analyses and public engagement that can be used to address the many issues that are likely to arise in future biotechnology products in a way that balances competing issues and concerns.
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In order to implement the appropriate rigor of risk analyses for new biotechnology products, it will be necessary to establish scientifically rigorous criteria based on factors affecting the perception of risk, the degree of uncertainty, and the magnitude of risk and nature of potential risks. To help articulate what capabilities, tools, and expertise might be useful to meet these objectives, the committee created a conceptual map for decision making aimed to assess and manage product risk, streamline regulation requirements, and increase transparency, as shown in Figure S-2.
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The pipeline of biotechnology products likely to emerge over the next decade probably will result in disruptive innovations and significant societal impacts; a carefully balanced, coordinated approach toward future biotechnology products that incorporates input from stakeholders -- including interested and affected parties, relevant federal agencies, and nontraditional product evelopers -- will be required. d The profusion of biotechnology products over the next 5–10 years has the potential to overwhelm the U.S.
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In addition to the conclusions and recommendations from this report, EPA, FDA, USDA, and other agencies involved in regulation of future biotechnology products would benefit from adopting recommendations made by previous National Academies' committees related to future products of biotechnology, which are consistent with the findings and recommendations in this report. Given the assessments of some future biotechnology products and the role of the regulatory system, many of the recommendations of previous National Academies' committees are directly relevant and should be considered when taking actions to enhance the capabilities of the U.S.
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Recommendation 2: EPA, FDA, and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation.
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• Recommendation 3-1: The federal government should develop and implement a long-term strategy for risk analysis of future biotechnology products, focused on identifying and prioritizing key risks for unfamiliar and more complex biotechnology products, and work to establish appropriate federal funding levels for sustained, multiyear research to develop the necessary advances in regulatory science. • Recommendation 3-2: Federal agencies that fund early-stage biotechnology-related research and regulatory agencies should provide support to academic, industry, and gov ernment researchers to close gaps and provide linkages to market-path requirements for regulatory success.
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14 PREPARING FOR FUTURE PRODUCTS OF BIOTECHNOLOGY • Recommendation 3-3: Government agencies that fund biotechnology development, work ing together with regulatory agencies and each other, should also invest in new methods of understanding the ethical, legal, and social implications associated with future biotechnol ogy products. • Recommendation 3-4: Government agencies with an educational mission, including those that support scientific training, should identify and fund activities that increase awareness and knowledge of the regulatory system in courses and educational materials for students whose research will lead to advances in biotechnology products.
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