TABLE 2.

Examples of possible oversight functions for the national biosafety and biosecurity agency.

Function	Description
Biosafety and Biosecurity Compliance Framework	Centralizing biosafety and biosecurity regulations from agencies like CDC, EPA, NIH, and USDA into a single cohesive framework. Developing a compliance monitoring system to ensure adherence to biosafety and biosecurity regulations. Implementing a whistleblower hotline for confidential reporting of non-compliance and safety and security concerns
Dual-Use Research of Concern Oversight	Establishing comprehensive national oversight for DURC to assess risks and benefits, develop risk mitigation plans, and reduce the risk of misuse. Creating guidelines for DURC identification and management for publicly and privately funded research institutions located in the United States or funded by the U.S. government in other countries. Ensuring regular review and monitoring of DURC projects by institutional biosafety committees. Reviewing risks and benefits of proposed research with pathogens with enhanced pandemic potential to determine if proposed research should be conducted and under what conditions. (Legislation is needed for comprehensive oversight of non-federally funded research; without legislation, privately-funded research can only be invited to voluntarily participate.)
Data and Research Security	Implementing robust protocols for the secure storage, handling, and transfer of genetic and biological data. Conducting audits and inspections to ensure data security and compliance with security protocols. Establishing guidelines for data sharing and transparency to facilitate research while ensuring security. Addressing the emerging concept of research security by incorporating best practices from NSF’s Research Security activities and relevant JASON reports. Enhancing these efforts by identifying gaps and areas where NBBA can add unique value, such as developing specialized training programs, creating additional security standards, and facilitating cross-agency collaboration
Pathogens with Enhanced Pandemic Potential (PEPP)	Creating guidelines and oversight mechanisms specifically for PEPP research. Establishing risk mitigation plans and review processes for PEPP projects
Safety and Containment Standards	Establishing and enforcing biological safety levels (e.g., BSL-1 to BSL-4) for containment facilities. Establishing stringent design, construction, and certification standards for high-containment facilities. Maintaining a national registry of all BSL-3 and BSL-4 facilities to monitor and ensure compliance with biosafety and biosecurity standards. Ensuring occupational health and safety standards are appropriate for biological workers. Developing standards to reduce the risk of exposure to infectious diseases during fieldwork. Implementing routine safety audits and inspections to ensure compliance with containment standards
Emerging Technology Oversight	Developing regulations for screening synthetic nucleic acid orders and benchtop nucleic acid synthesis equipment. Maintaining a directory of synthetic nucleic acid providers and manufacturers. Conducting horizon scanning exercises, assessing risks of emerging technologies, and identifying risk mitigation options. Developing and maintaining registries for gene drive research and ecological releases to track and monitor developments in these fields. NBBA should also determine which DNA providers are successfully performing screening and are therefore eligible to sell DNA to users, as mandated by EO 14110
Applied Biosafety and Biosecurity Research	Conducting and funding research projects focused on improving biosafety and biosecurity practices and technologies. Developing and promoting new technologies for enhanced biosafety and biosecurity. Collaborating with academic institutions to advance biosafety and biosecurity research. Providing funding to study occupational health and safety protection measures
Incident Reporting and Investigation	Establishing and maintaining a centralized incident reporting system. Analyzing incident reports to identify trends and improve biosafety and biosecurity protocols. Investigating incidents to determine the cause, identify remedies, and ensure accountability
International and Cross-Sector Collaboration	Coordinating with international bodies to harmonize and improve biosafety and biosecurity standards. Conducting biosafety and biosecurity capacity-building programs for laboratories in partner nations based on international standards (e.g., ISO 35001) for laboratory biosafety and biosecurity. Facilitating cross-sector collaboration to enhance biosecurity innovation and address emerging threats
Education, Training, and Workforce Development	Developing and delivering standardized educational materials and training programs on safe, secure, and responsible research. Hosting workshops and conferences to keep professionals updated on the latest biosafety and biosecurity practices. Creating certification and recertification programs for biosafety and biosecurity professionals
Environmental Risk Assessment	Conducting assessments to evaluate and mitigate potential ecological risks of biotechnologies. Developing guidelines for conducting environmental impact assessments for biotechnology. Monitoring and evaluating the long-term ecological impacts of biotechnological applications
Laboratory Animal Care and Use	Overseeing the humane and ethical care and use of animals at research facilities. Reviewing animal welfare assurances. Maintaining a registry of Institutional Animal Care and Use Committees
Biological Material Import and Transport	Reviewing applications for the import of infectious biological materials and vectors. Establishing secure and standardized procedures for the import and export of biological materials. Ensuring compliance with shipping protocols for biological materials and international regulations. Monitoring the transportation of high-risk biological materials to prevent unauthorized access or misuse