Appendix C

Requests for Information

In an attempt to better ascertain the nature and extent of federal research designed to support risk analyses of biotechnology products, the committee solicited input from relevant agencies through a request for information (RFI). The questions posed through the RFI were derived, in part, from the report Creating a Research Agenda for Ecological Implications of Synthetic Biology published in 2014 following two workshops organized by the Massachusetts Institute of Technology Program on Emerging Technologies and the Wilson Center’s Synthetic Biology Project (Drinkwater et al., 2014) and a workshop and Delphi study on synthetic-biology governance (Roberts et al., 2015). The committee was interested in programmatic work related to fundamental and applied research efforts that can inform human, animal, and ecological risk assessments and social and economic costs and benefits. Research related to potential risks of future human drugs or medical devices was not included in the committee’s statement of task and therefore was not part of this RFI, except to the extent such research may be broadly applicable to other biotechnology products.

REQUEST SENT TO AGENCIES

“Rapid scientific advances are expanding the types of products that can be generated through biotechnology. In response to a request from the White House Office of Science and Technology Policy, the National Academies of Sciences, Engineering, and Medicine have convened a committee of experts to identify the kinds of products that may be produced with biotechnology in the next 10 years. The U.S. regulatory system for biotechnology products was originally designed in the 1980s, so the committee will also provide advice on the scientific capabilities, tools, and expertise that may be necessary to regulate those forthcoming products and on whether potential future products could pose different types of risks relative to existing products and organisms. The committee’s report is expected to be released at the end of 2016.

“To help it address its statement of task, the Academies committee is requesting information on the status of federal research programs that address future biotechnology products. The questions below are derived, in part, from the report Creating a Research Agenda for Ecological Implications of Synthetic Biology, published in 2014 following two workshops organized by the Massachusetts

Institute of Technology Program on Emerging Technologies and the Wilson Center’s Synthetic Biology Project. The committee is 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. Research related to potential risks of future human drugs or medical devices is not included in the committee’s statement of task and is therefore not part of this request for information (RFI), except to the extent such research may be broadly applicable to other biotechnology products.

“This RFI addresses the level of intramural and extramural research investments for fiscal years 2012, 2013, 2014, 2015, and 2016 (current and anticipated obligations). It also includes a general question concerning research planning and processes whereby research products are adapted and vetted for use in future risk analyses.”

Requested Information

“Please provide an estimate of intramural Full-Time Employees and extramural obligations by fiscal year (FY2012, FY2013, FY2014, FY2015, and FY2016) in each of the areas outlined below. As available, please provide links to associated project descriptions and links to any peer-reviewed publications.

1. Comparators. Research addressing the nature and extent to which comparisons of future modified organisms, or communities of modified organisms (including those associated with the human microbiome), can be made to wild-type organisms or communities of organisms, to inform problem formulation, risk characterization, and post-market monitoring and surveillance. Include research to address scenarios where there are no “present-day” analogues to the modified organisms.
2. Nontarget Gene Effects and Phenotypic Characterization. Research addressing techniques to assess the nature and extent of effects on nontarget genes and unintended phenotypes; understanding phenotypic functions of new traits and how the environment influences expression of the functions; phenotypic characteristics most relevant to near-term perturbations versus long-term consequences in humans, other organisms, communities, or ecosystems.
3. Impacts on Nontarget Organisms. Research addressing exposure of future biotechnology products to humans and other nontarget organisms and resultant toxicity (including allergenic responses). Research addressing changes in nontarget species’ populations through indirect effects of future biotechnology products due to perturbations in trophic relationships (e.g., reductions in prey and other food sources) and habitat alteration.
4. Fitness, Genetic Stability, and Lateral Gene Transfer. Research addressing approaches to assess gene persistence and stability of genetic material across generations; potential for genes to transfer to unrelated species with increased consistency and reliability.
5. Control of Organismal Traits. Research addressing intrinsic and external control measures designed to meet specified levels of risk mitigation for intentional or accidental releases.
6. Life-Cycle Analyses. Research on the effects future biotechnology products may have on life-cycle processes, such as water utilization and fossil fuel and mineral extraction and consumption.
7. Monitoring and Surveillance. Research addressing options for indicators and spatial and temporal sampling designs for human subpopulations, animals, and ecosystems for broad-based detection capabilities or specific applications in proactive or reactive situations.

8. Modeling. Research on the use of conceptual models (e.g., in the problem formulation step of risk assessments), physical models (e.g., human organs on a chip, mesocoms), and computational models to help inform risk-based hypotheses in assessments, to direct collection of additional data to reduce uncertainties in assessments, or to provide definitive findings or predictions in risk characterization.
9. Economic Costs and Benefits. Research on techniques to quantify the near-term and long-term economic costs and benefits of future products, including comparative analyses with extant products, that address household, community, regional, national, and international scales.
10. Social Costs and Benefits. Research on techniques to quantify the near-term and long-term social costs and benefits of future products, including comparative analyses with extant products, that address household, community, regional, national, and international scales.
11. Other Areas of Research not addressed above.
12. Please describe research planning processes within your organization and with sister federal agencies. To what extent do risk assessors, risk managers, grant project officers, intramural researchers, and, as appropriate, extramural researchers, meet on a regular basis to identify future research needs and identify steps by which anticipated research products will be adapted and vetted for use in risk assessments or socioeconomic cost–benefit analyses? For example, are there ongoing discussions concerning the nature and extent of potential monitoring and/or surveillance needs for the future? Are there ongoing discussions concerning approaches for standardizing methods for data collection and management?”

RESPONSES FROM AGENCIES

REFERENCES

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