Preparing for Future Products of Biotechnology (2017) / Chapter Skim
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4 Understanding Risks Related to Future Biotechnology Products
4 Understanding Risks Related to Future Biotechnology Products
Pages 107-136
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From page 107... ...
RISKS FROM FUTURE BIOTECHNOLOGY PRODUCTS: SIMILARITIES TO THE PAST AND GAPS GOING FORWARD As discussed in Chapter 3 (see Box 3-1) , risks are comprised of undesirable outcomes (what)
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From page 108... ...
The present committee hypothesized that this phrase referred to the final risk-assessment endpoints identified in human health and ecological risk assessments. As these are the kind of assessments that have most commonly been conducted under the auspices of the Coordinated Framework, the committee interpreted its charge to identify "different types of risks" to mean that it should assess the degree to which risk-assessment endpoints identified in human health and ecological risk assessments for existing biotechnology products are likely to be similar to or different from the endpoints that would be selected when assessing risks for future biotechnology
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From page 109... ...
products. The question in the statement of task about different types of risks was also interpreted by the committee as a request to compare the risk hypotheses linking assumed routes of exposure to possible effects and the spatial and temporal scales used in existing risk assessments with those that may be needed for future products.
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From page 110... ...
The human health and ecological risk-assessment endpoints would therefore likely be the same for existing and future products, but risk assessments for a future product -- for example, a microbial consortium intended for use in a contained system -- may not be as "simple" as current risk assessments for a single, engineered microbe. For example, if there was an accidental release of a living consortium into a waste stream, what is the potential 1The committee observed that if compounds produced by future biotechnology products were already regulated by EPA (for example, industrial chemicals regulated under the Toxic Substances Control Act)
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From page 111... ...
, if not risk-assessment endpoints themselves, for future biotechnology products that are manufactured within a home and intended to be used indoors by household members is likely more complex than it is for future products associated with Scenario 1. The nature of exposure pathways and means to estimate environmental releases are less certain as compared to the dimensionality of risk assessments associated with contained manufacturing processes traditionally regulated under TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
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From page 112... ...
The potential effects of released organisms to the microbial systems in publicly owned treatment works or receiving bodies would be less certain if the potential effects had not been previously characterized. Finally, as with Scenario 1, the dimensionality of risk hypotheses for the disposal scenarios of future biotechnology products will likely be higher and the information to support risk characterization less certain.
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From page 113... ...
and examples of risk-assessment methods for non-GE biocontrol agents and the release of non-native organisms (Fairbrother et al., 1999; Orr, 2003; Landis, 2004) ,2 risk assessments for future biotechnology products that are designed to introduce a new species or suppress or enhance an existing species reflect a high degree of dimensionality and entail a diversity of endpoints at varying levels of biological organization.
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From page 114... ...
. Risks or Lack of Risks That Are Well Understood As noted in the introduction of the chapter, the committee interpreted the first question in this part of the statement of task as a request to reflect on the degree to which regulatory human health and ecological risk-assessment endpoints used in risk assessments for existing biotechnology products are likely to be similar to or different from the endpoints that would be selected when assessing risks for future biotechnology products.
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From page 115... ...
Risks That Are Well Understood Although it was not possible to quantitatively determine risks that are well understood, a future biotechnology product that is based on a similar genetic modification and has a similar use pattern as an existing biotechnology product with a safe-use record likely has a risk profile similar to that of the existing product. The scenarios in the above section could be used for pilot projects to develop probabilistic estimates of risks for existing biotechnology products and thereby provide the means to compare the likelihood of adverse effects from future biotechnology products to the likelihood of adverse effects from existing biotechnology and nonbiotechnology products, assuming risk assessments for future products incorporate probabilistic methods.
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From page 116... ...
Products Without Comparators. Existing biotechnology risk assessments are guided by comparative risk approaches and are informed by comparisons to nonbiotechnology counterparts that help establish the "as safe as" criteria used by regulatory decision makers. As described in Chapter 2, existing biotechnology products have typically involved a host (the organism into which new material is introduced)
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. There are also examples in the literature describing how components of existing ecological risk assessments could be enhanced to provide a probabilistic risk estimate (Wolt and Peterson, 2010)
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Use of a biological component or system that has a history of safe use provides an existing regulatory path with known nonbiotechnology comparators and clear risk-assessment endpoints, whereas using an unfamiliar component or system does not. Future biotechnology products may be unique and therefore lack adequate precedents.
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From page 119... ...
. Future products of biotechnology will be more complex in terms of their interactions with their environment and society, and more research may be needed to develop methods for governance systems that integrate ethical, cultural, and social implications into formulation of risk-assessment endpoints and risk characterization in ways that are meaningful.
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From page 120... ...
To assess the capacity of the federal government to regulate future biotechnology products, the committee looked at the existing capabilities in the workforce, the available external resources that could be drawn upon by the agencies, and the present investment in key tools for biotechnologyproduct evaluation. The committee also noted current opportunities to enhance capability and capacity through interactions across the federal agencies and through partnerships with developers, nongovernmental organizations, and academia.
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FedScope database, employment trend cubes. Available at https://www.fedscope.opm.gov/etrend.asp.
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FedScope database, employment trend cubes. Available at https://www.fedscope.opm.gov/etrend.asp.
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Department of Agriculture's Animal and Plant Health Inspection Service with more than 300 employees, fiscal years 2011–2015. NOTE: General Natural Resources Management and Biological Sciences includes employees hired with expertise in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
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to review risk assessments and resistance management plans for Bt plant-incorporated protectants since the mid-2000s.10 In 2014, the FIFRA SAP reviewed EPA's proposed problem-formulation approach for RNA interference (RNAi) technology in anticipation of future human health and ecological risk assessments of specific RNAi products (EPA, 2014a)
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. Agencies responsible for regulating future biotechnology products can also build from experience to proactively gain advice and input on proposed risk-assessment approaches for other future products and assessment techniques in areas like nanotechnology (EPA, 2009)
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. EPA, USDA, and USGS already maintain and employ large geospatial data sets to support human health and ecological risk assessments12 and agriculture and natural resource research and management within the governance of the Federal Geographical Data Committee (NRC, 2013)
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. The committee was interested in programmatic work related to fundamental and applied research efforts that can inform human, animal, and ecological risk assessments and socioeconomic costs and benefits.
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Department of Agriculture on programmatic work related to fundamental and applied research efforts that can inform human, animal, and ecological risk assessments and socioeconomic costs and benefits, 2012–2015. NOTES: Life-cycle analysis, economic costs and benefits, and social costs and benefits are outside the authorization of the BRAG program.
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The U.S. Army Corps of Engineers invested $2.08 million during the same time period ($1.24 million in fitness, gene stability, and horizontal gene transfer; and $0.84 million in monitoring and surveillance)
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Although EPA did not have direct investments for risk analyses of future biotechnology products, its efforts in risk-analysis research in other areas can be applied toward biotechnology products. A 2015 Woodrow Wilson Center report estimated that in 2008–2014 the U.S.
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It is difficult to determine the appropriate level of investment for risk research to support oversight of future biotechnology products; however, the sense of the committee is that the current level is insufficient. The committee is also concerned that the current U.S.
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Although the nature of human health and ecological risk-assessment endpoints that will need consideration are similar to those identified with existing products, the pathways to these endpoints will differ in complexity. To the extent future indoor manufacturing will occur in domestic settings, the types of risk-assessment endpoints of future biotechnology products that need to be considered will likely be similar to those used with existing indoor manufacturing; however, the dimensionality of these risk assessments will be more complex and the risk estimates will be more uncertain.
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Given the nature and diversity of future biotechnology products, increased public and developer participation may improve both the understanding and quality of risk-analysis approaches. With better understanding of real or perceived gaps in the risk-analysis process, regulators would be better equipped with the capabilities needed to strengthen risk analysis.
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2014a. Notice of FIFRA SAP Meeting; RNAi Technology as a Pesticide: Problem Formulation for Human Health and Ecological Risk Assessment, January 28.
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Webinar presentation to the National Academies of Sciences, Engineering, and Medicine Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Bio technology Regulatory System, July 25. Kuzma, J., J
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2010. Prospective formulation of environmental risk assessments: Probabilistic screening for Cry1A(b)
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