Biotechnology: Applications, Challenges, and Policy Options for Engineered Microbes for Waste Cleanup

What GAO Found Certain types of waste are particularly pervasive or difficult to clean up with existing technologies. Microbes (e.g., bacteria, fungi) can be engineered to break down pollutants more effectively. For example, researchers have inserted genes into bacteria that allow the bacteria to break down contaminants, such as phenol or hydrocarbons, in water and soil. At present, there are no examples of commercially available engineered microbes for waste cleanup. Example areas where engineered microbes could be deployed for waste cleanup Through expert interviews and document reviews, GAO identified two policy goals related to this biotechnology—demonstrating safety and effectiveness and developing a market. GAO identified challenges hindering these goals, including: Insufficient testing infrastructure and standards. The current testing infrastructure and standards are insufficient to scale experimentation beyond the lab or to assess the safety and effectiveness of engineered microbes. Regulatory catch-22. According to experts, when authorizing experimental release, the Environmental Protection Agency (EPA) requests information that is difficult to obtain without experimental release. EPA officials told GAO that information from published studies or lab data can suffice for permitting experimental release. Unclear regulatory roles and responsibilities. According to GAO’s research, developers lack clarity about the regulatory process for engineered microbes. For example, it is often not clear to developers which agency is responsible for regulating a given engineered microbe and why. EPA officials told GAO, however, that they get very few questions regarding jurisdiction. Public concerns. Developers may hesitate to invest in research and development of the technology if there is not sufficient public support. Public concerns include the potential for persistence in the environment, possible health effects, and discomfort with manipulating and patenting genetic material. See tables 1–5 in this report for additional policy options and details. Based on review of scientific reports, agency documents, and expert interviews, GAO developed 10 options that policymakers could consider if they wish to advance the two goals identified above (demonstrating safety and effectiveness of or developing a market for engineered microbes for waste cleanup). GAO also considered the policy goal of pursuing alternatives to this biotechnology and developed three options policymakers could consider to achieve that goal (not shown on this page; see chapter 5). The following table shows selected policy goals and policy options. See tables 2–8 in the full report for additional policy options and details. Selected policy goals and policy options related to engineered microbes for waste cleanup Policy Goal: Demonstrating safety and effectiveness Policy option Establish databases to share noncompetitive field trial data among developers (report page 21) Opportunities Could decrease risk in technology development and accelerate product development. Could reduce testing burden on developers. Considerations Efforts may be limited by developers’ willingness to share proprietary data. Specific data about government owned sites may be sensitive. Policy option Update legal requirements and associated guidance documents (report page 23). Opportunities Could provide a scaled approach to regulations for small-scale research and better enable research on engineered microbes for environmental release. Updated regulations may remove the requirement to conduct a regulatory review based on intergeneric genetic changes. Considerations Updates may not be necessary if agencies can provide better guidance or a coordinating office (see below) to help developers navigate the regulations. Changes may add significant time or burden on regulatory agencies. Policy Goal: Developing a market Policy option Establish a national office for biotechnology coordination (report page 26). Opportunities Could serve as a first point of entry for developers of biotechnologies seeking information on how regulations apply to them. Could provide greater clarity on and assistance with navigating the regulations that apply to specific biotechnology products, including engineered microbes. Could reduce burden on agencies by taking on specific functions, such as public outreach and coordination among agencies. Congressional action could provide more stability than executive action, which can be rescinded by a new administration. Considerations Could add another step, further delaying the regulatory review process. Will require resources. Agencies may object to another entity making legal determinations about which agency has regulatory authority in a given matter. Each agency would still have to follow their individual statutory requirements. Policy option Provide community education (report page 29). Opportunities Could improve public literacy and understanding of new technologies, promoting informed decision making about the use of engineered microbes. Could improve public understanding of the effects of waste and contamination in the environment, which may increase interest in cleanup efforts. Considerations May require substantial resources to implement. May not be as effective as efforts that prioritize engagement. Why GAO Did This Study Contamination of land and water with waste chemicals poses significant threats to human health, the economy, and the environment. Research has shown that microbes can be engineered to break down these chemicals, potentially offering promise for cleanup in multiple sectors, including defense, mining, agriculture, and manufacturing. GAO conducted an assessment of current and emerging engineered microbe technologies for waste cleanup. This report examines (1) the status, benefits, and risks of engineered microbes for waste cleanup, (2) the challenges of developing or using engineered microbes for waste cleanup, and (3) options policymakers could consider to achieve various goals related to this biotechnology. To conduct this work, GAO reviewed scientific reports and federal agency documents. GAO also interviewed federal agency officials and 25 other experts from academia, industry, and nonprofit organizations. GAO is identifying policy options in this report. For more information, contact Sarah Harvey at HarveyS@gao.gov.

Biotechnology: Applications, Challenges, and Policy Options for Engineered Microbes for Waste Cleanup

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