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Research Needs for Novel Engineered Microbes & Biopesticides Intended for Open Release into the Environment
Citation:
Reichman, J. R., G. Mcclung, K. Nguyen, A. Pierce, W. Striegel, AND C. Wozniak. Research Needs for Novel Engineered Microbes & Biopesticides Intended for Open Release into the Environment. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-22/163, 2022.
Impact/Purpose:
As development of emerging biotechnology products is enhanced by molecular techniques including genome editing, use of synthetic elements, and metabolic engineering, risk assessors will be challenged in assessing both human health and environmental impacts. In many instances, risk assessments are based in part on existing information from available literature including the use of established databases to query for similarities to known comparators. The expansion of novel product types and intended uses will require greater empirical data generation by researchers and product developers plus the use of mathematical models to aid in risk assessments. The Biotech Workshop participants sought to identify the most pertinent research priorities regarding engineered microbes and biopesticides to be released into the environment. The workshop focused on areas needing attention for risk assessors evaluating products under TSCA and FIFRA/FFDCA oversight, which will help to guide further research in EPA/ORD and collaborating labs toward addressing some of the knowledge gaps. The key research needs identified were:
- Refined use of laboratory and mesocosm experiments
- Collection and utilization of baseline data on communities
- Improved tracking methods for engineered organisms and synthetic constructs
- Increased stakeholder engagement for field testing
- Alternative options for stages of field testing
- Toxicity and/or allergenicity of biomolecules from biotech products
- Environmental persistence and spread of products
- Stability and efficacy of biocontainment strategies
- Detection and impacts of horizontal gene transfer
- Development and use of advanced models and databases
- Recruitment and retention of new researchers
- Establishment of collaborations between Agencies, Departments, and external partners
The overlap among the challenging priorities above and those previously identified in reports on biotechnology products reinforces the point that substantial research efforts and investment are needed to support timely and accurate regulatory decision making by the Agency and other organizations. An iterative process is anticipated wherein research projects funded through the EPA STAR granting program conducted primarily in academic institutions plus those performed in ORD and other collaborating laboratories lead to gains in our understanding that are reflected in future guidelines and approaches to risk assessments and risk management decisions.
Description:
Recent advances in biotechnology and biomanufacturing are positively impacting many sectors of society and the bioeconomy. Updated scientific information and assessment tools are needed to ensure the safety and sustainability of novel products of biotechnology that have unique properties and uncertain risks. In July 2021, seventy-seven individuals participated in a virtual workshop hosted by the EPA Office of Research and Development to discuss research needs for engineered microbes and biopesticides intended for open release into the environment. Government and external subject matter experts gathered to discuss the needs in terms of empirical experiments, monitoring, models, databases, research capacity, collaborations, and priorities. The workshop sessions were initiated with plenary talks from experts including awardees from the 2020 EPA Science to Achieve Results (STAR) grants for Assessment Tools for Biotechnology Products. Follow-on Breakout Group discussions were focused on four biotech product categories: Engineered Microbes-1; widespread open uses, biofertilizers, ocean bioremediation, etc. Engineered Microbes-2; semi-contained uses, algae ponds, biomining, biosensors, wastewater treatment, localized bioremediation, microbial enhanced oil recovery, etc. Biopesticides-1; population control/elimination, Wolbachia, release of insects with dominant lethality (RIDL), gene drives, etc. Biopesticides-2; plant incorporated protectants (PIPs), microbial pest control agents (MPCA), double-stranded ribonucleic acid (dsRNA), biochemicals, etc. This report on the workshop findings delineates research priorities that are relevant to OCSPP TSCA and FIFRA/FFDCA risk assessments as well as those made by other organizations on emerging products of biotechnology derived through synthetic biology, genome editing and/or metabolic engineering. Overall, the report identifies important biotech research questions facing the Agency and in turn, it can be used to develop a strategy to focus ORD's future research and collaborations in this area.