Risk Analysis of Biotechnology for the Protection of Environmental Resources

The overarching objective of this program is to develop the core features of adaptive and resilient risk management frameworks that can maximize the environmental benefits and minimize the environmental harms of novel biotechnologies in the context of environmental stewardship-

shared responsibility for ensuring environmental quality. Within that context, the following are objectives for this research:

Objective 1: Comparative analysis of the core elements of existing and emerging risk management frameworks and stewardship practices regulating environmental biotechnology

This objective builds on existing ERDC research into the risk management of novel environmental biotechnology that identifies key principles for best practice and knowledge gaps. In collaboration with scientific and social scientific experts in the USA and NATO partner countries, ERDC has taken the first steps to identify key requirements for the effective risk management of environmental biotechnology. The next step in this process must be to assess the fit of these requirements with existing practice. Objective 1 will include the following: i) identification of existing risk management and stewardship practices relevant to the regulation of rapidly-emerging environmental biotechnology applications, ii) comparative analysis identifying the common and distinct properties of these systems, iii) development of application-specific scenarios that can inform the identification of key metrics in objective 2.

Objective 2: Identification and assessment of key metrics impacting the resilience of existing and emerging risk management methodologies and community partnerships

ERDC research predicts that AI-accelerated research and development of environmental biotechnology is likely to outmatch the capacity of existing risk management and stewardship practices to ensure its safe and responsible use, necessitating the adoption of alternative approaches that are more flexible and resilient. At present, there are few to no objective metrics to comparatively evaluate biotechnology research and development, which limits ability to understand and adopt aligned or diverging approaches to managing pathogenic, environmental, and biodiversity risks. Building on the work in Objective 1, this objective includes the following: i) identification of key capacity metrics related to existing risk management and stewardship practices, ii) collection of data for those metrics across the systems identified in Objective 1, iii) quality assessment of the collected data.

Objective 3: Comparative biotechnology modernization forecasting- characterizing future relationships in environmental stewardship

Building on Objectives 1 and 2, this objective uses the identified metrics to build test scenarios underlying our understanding of risk management and stewardship practice among these systems. This objective includes the following: i) network analysis of the inter-relationships between risk management components, ii) development of scenarios that examine the impact of specific technology development on risk management and stewardship practices under the presence or absence of key components, iii) use of the capacity metrics identified in Objective 2 to examine how stewardship will fare under these different scenarios and the likely outcomes for environmental and human health.

D. Public Benefit

This work will improve understanding of how biotechnology activities must be regulated to generate public value and protect the public interest. It will improve our capabilities in promoting widespread access to the benefits of novel environmental biotechnology and preventing and mitigating against related potential harms and threats to human health and the environment.