Preparing for Future Products of Biotechnology (2017) / Chapter Skim
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6 Conclusions and Recommendations
6 Conclusions and Recommendations
Pages 171-186
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From page 171... ...
, 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. In this final chapter, the committee has summarized its major conclusions, organized against the statement of task, and made selected recommendations for next steps to be taken to enhance the capabilities of the U.S.
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From page 172... ...
The number of actors who are involved in product development will also increase and diversify beyond just companies and academia, creating the additional regulatory challenge of product developers who may have little familiarity with risk analysis and with the regulatory system. CURRENT RISK-ANALYSIS SYSTEM AND AGENCY AUTHORITIES The committee was also asked to "describe the existing risk analysis system for biotechnology products including, but perhaps not limited to, risk analyses developed and used by EPA, USDA, and FDA, and describe each agency's authorities as they pertain to the products of biotechnology." In carrying out this charge, the committee reviewed the Coordinated Framework for Regulation of Biotechnology, including the 2017 update to the Coordinated Framework (EOP, 2017)
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From page 173... ...
Failure to anticipate regulatory requirements creates the potential to complicate developers' business plans and delay the risk analyses associated with the decisions to allow future biotechnology products to enter the market.
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From page 174... ...
The committee reached the following conclusions: Conclusion 6-4: The risk-assessment endpoints for future biotechnology products are not new compared with those that have been identified for existing biotechnology products, but the pathways to those endpoints have the potential to be very different in terms of complexity. The biotechnology products emerging in the next 5–10 years pose a diverse array of environmental, health, and safety risks that vary widely in terms of their potential impacts, likelihood of occurrence, spatial and temporal dimensions, and the appropriate regulatory policies for their assessment.
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From page 175... ...
OPPORTUNITIES FOR ENHANCEMENT Finally, the committee was asked to "indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology." The committee reviewed the current expertise within EPA, FDA, and USDA and analyzed the investments that those agencies and others are making in areas related to risk analyses. The committee concluded: Conclusion 6-7: The staffing levels, expertise, and resources available in EPA, FDA, USDA, and other agencies that have interests related to future biotechnology products may not be sufficient to handle the expected scope and scale of future biotechnology products.
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From page 176... ...
Future biotechnology products will be more complex in terms of their internal and external interactions, and it is critical that the agencies involved in regulation of biotechnology develop and maintain scientific capabilities, tools, and expertise in relevant areas. Furthermore, it will be essential that the agencies stay apprised of technology trends so that they can engage in meaningful discussions with technology and product developers early in the product-development cycle, where there is often the best opportunity to affect future technologies.
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From page 177... ...
In order to be prepared for future products of biotechnology that will enter the regulatory pipeline, regulatory agencies should have an informed view of the underlying technologies that will lead to those advancements. Regulatory agencies should provide training programs to continually maintain technical expertise commensurate with the scope, scale, and complexity of future biotechnology products and may wish to consider annual or biannual training at technical workshops to learn and apply state-of-the-art technologies.
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From page 178... ...
This approach has been employed by EPA for other areas of environmental risk assessment and research, as noted in Chapter 4.1 Recommendation 1-4: EPA, FDA, USDA, and other relevant federal agencies should create a precompetitive or preregulatory review "data commons" that provides data, scientific evidence, and scientific and market experience for product developers. A key element in future regulation of biotechnology products will be increased scientific understanding of the complex interactions between a variety of traits and functions that will form the core of future products of biotechnology and the increasingly complex interactions between products of biotechnology and their host environments.
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From page 179... ...
The committee supports the initial steps of the BWG and encourages it to establish more permanent mechanisms to measure progress against and periodically review federal agencies' scientific capabilities, tools, expertise, and horizon scanning as they apply to the profusion of future biotechnology products. Recommendation 2: EPA, FDA, USDA, and other relevant agencies should increase their investments in internal and external research and their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future bio technology 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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From page 180... ...
Recommendation 2-1: Regulatory agencies should create pilot projects for more itera tive processes for risk assessments that span development cycles for future biotechnol ogy products as they move from laboratory scale to prototype or field scale to full-scale operation. The pilot projects could address iterative assessments within design cycles for future biotechnology products by adapting the approach outlined in the National Academies report on gene drives (NASEM, 2016a)
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From page 181... ...
Regulatory agencies are likely not prepared with sufficient staff, appropriate ecological risk-assessment approaches, and corresponding guidance for development and evaluation of associated product data packages. Public confidence in government oversight of emerging technologies may be eroded to the extent there is a lack of transparency and clarity as to how regulatory authorities are undertaking ecological risk assessments, including identifying societal values in addition to taking input from biotechnology developers in formulating regulatory decisions.
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From page 182... ...
The interagency dialogue should primarily engage agencies such as the Consumer Product Safety Commission, the Occupational Safety and Health Administration, and CDC that have broad responsibility for consumer and occupational safety and public health, but the diversity of future biotechnology products may, on a case-by-case basis, implicate the safety oversight roles of a much longer list of agencies (for example, the National Highway Traffic Safety Administration for automotive applications) that also need effective pathways for engagement in the Coordinated Framework.
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From page 183... ...
In the same way that the National Institutes of Health (NIH) requires all universities that receive NIH funding to offer courses in biosafety and bioethics, the profusion of future biotechnology products would benefit from the inclusion of material on the regulatory process and risk-assessment frameworks and tools in textbooks, scientific literature, and regulatory agency websites.
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From page 184... ...
The committee notes that this recommendation is supported by recommendations in the National Academies reports on gene drives and genetically engineered crops, which stated: There is an urgent need for publicly funded research on novel molecular approaches for testing future products of genetic engineering so that accurate testing methods will be available when the new products are ready for commercialization.
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From page 185... ...
At the time of completion of their degrees and postgraduate training, many of the students and postdocs who will go on to make important contributions to the technology of future biotechnology products may not be aware of the Coordinated Framework and may not have been exposed to methods of risk assessment and risk management that are part of the Coordinated Framework. Encouraging the development and inclusion of educational materials that provide insights and context to the regulation of biotechnology, along with quantitative tools for measuring uncertainty that forms the basis of quantitative risk assessment, could substantially benefit the governance, oversight, and regulation of future biotechnology products.
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From page 186... ...
2017. Modernizing the Regulatory System for Biotechnology Products: An Update to the Coordinated Framework for the Regulation of Biotechnology.
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