Response to RFI; National Biotechnology and Biomanufacturing Initiative
On January 20, 2023, the Johns Hopkins Center for Health Security provided a response to a request for information (RFI) posted by the Office of Science and Technology Policy (OSTP) to inform the National Biotechnology and Biomanufacturing Initiative (NBBI) created under Executive Order 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The RFI was released to gather input on “how advances in biotechnology and biomanufacturing can help us achieve goals that were previously out of reach and what steps can be taken to ensure we have the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy.” The recommendations stem from research conducted by the Center, including on the biotechnology workforce, bioeconomy, and biosafety.
Suggested citation: Attal-Juncqua A, Montague M, Walsh M, Gronvall GK. Response to RFI; National Biotechnology and Biomanufacturing Initiative. Baltimore, MD: Johns Hopkins Center for Health Security; 2023.
Section on Reducing Risk by Advancing Biosafety and Biosecurity
Q12. What can the Federal Government do to support applied biosafety research and biosecurity innovation to reduce risk while maximizing benefit throughout the biotechnology and biomanufacturing lifecycles?
- Federal funding should be made available for applied biosafety research, specific for biosafety in a laboratory context as well as for biomanufacturing and biotechnology products.
- Funding mechanisms are not usually available for biosafety studies, in contrast to other occupational health concerns (e.g., the Centers for Disease Control & Prevention’s National Occupational Research Agenda, or NORA). Without dedicated research studies and the systematic collection of data, determining principles for biosafety can rely too much on anecdote and past experiences, which do not necessarily take into consideration the development of new technologies. As the biotechnology products of the future pose new potential safety and security risks, research into how to characterize and mitigate concerns while allowing technology development to proceed requires dedicated funding.
- As biotech and biomanufacturing applications increasingly move out of traditional laboratory environments, the Federal Government should fund studies to measure the impact of new biological products on individuals and the environment.
- The Federal Government should invest in infrastructure needed for environmental monitoring and surveillance systems to characterize “normal” background environments and to pick up specific genetic signals to determine how newly engineered biological products or organisms behave and interact with their environments.
- Studies identifying opportunities for biosafety research of novel products should also characterize the capital cost and ease of adoption of biosafety investments for nontraditional, noninstitutional actors, such as DIY labs and small startups. For example, automation infrastructure, like most biosafety investment, requires significant upfront investment, often justified by cost-benefit analyses that could include risk reduction if the required information about accidents was known. The Federal Government should fund research to better understand where, when, and how accidents happen to delineate the processes that would benefit from automation.
- Other potential research areas of interest that should be considered for funding include procedural studies aimed at identifying protocols or equipment needed to mitigate risks, as well as social and behavioral studies that look at how to best create and promote a biosafety culture across the life sciences industry.
- The Federal Government should prioritize investments needed to kick start the development of a domestic biosafety and biosecurity workforce.
- The Federal Government should invest in efforts to increase the number of biosafety professionals, including certification programs, degrees, graduate research grants, competitions (e.g., iGEM, or similar), and other training curricula in collaboration with industry and in a variety of educational settings (e.g., community colleges, Historically Black Colleges and Universities, Tribal Colleges and Universities, Hispanic Serving Institutions, 4-year institutions, and others).
- The Federal Government should invest in efforts to increase the number of biosafety professionals, including certification programs, degrees, graduate research grants, competitions (e.g., iGEM, or similar), and other training curricula in collaboration with industry and in a variety of educational settings (e.g., community colleges, Historically Black Colleges and Universities, Tribal Colleges and Universities, Hispanic Serving Institutions, 4-year institutions, and others).
- The Federal Government should expand its definition of applied biosafety to 1) encompass biosecurity-related outcomes, 2) recognize that biological and biotechnology will routinely exist outside of the laboratory and in the environment, and 3) include biomanufactured products.
- As our ability to engineer biology continues to progress, applications of engineered organisms will increasingly move out of traditional laboratory environments and into the environment. Biomanufactured products will also become commonplace, yet current definitions of biosafety are generally focused on what occurs in a laboratory setting and are often disconnected from biosecurity.
- Such definitions do not encompass the range of activities and considerations required for future biosecurity and biosafety needs.
Q13. How can Federal agencies that fund, conduct, or sponsor life sciences research incentivize and enhance biosafety and biosecurity practices throughout the United States and international research enterprises?
- Federal agencies could enhance biosafety and biosecurity practices by creating targeted financial incentives.
- Federal agencies that fund or sponsor life science research should require documentation of biosafety and biosecurity steps incorporated into research reporting for federal funding.
- As was done with the Human Genome Project, a specific percentage of federal funding should be dedicated for other important research goals, in this case biosafety, biosecurity, sustainability, and responsible conduct of research.
- Federal agencies and federal regulators should prioritize the development of biosafety and biosecurity risk assessment frameworks, in tandem with R&D efforts.
- The pace at which biotechnology and biomanufacturing are evolving requires nimble risk assessment frameworks that can be adapted to entire new classes of bioproducts and are able to conceptualize risks to individuals in both laboratory and environmental settings.
- If these new risk assessment frameworks are to become economically and culturally viable international standards, they also will have to consider the capacities needed to implement them and how to tailor them to different needs and environments.
- The Federal Government should work toward international norms and federal agencies should enhance international collaboration with allies on issues related to biotechnology, biomanufacturing, biosafety, and biosecurity.
- The Federal Government and its agencies should identify and collaborate with international leaders in biosafety and biosecurity and leverage these partnerships to create and disseminate shared international norms, reinforce unified messages countering mis/disinformation that threaten the industry, and protect the bioeconomy at home and abroad.
- Finding, recognizing, and crediting like-minded champions around the world will be critical in the long term to foster and elevate emerging leaders, integrate and protect supply chains with allies, and ultimately develop a shared understanding of what it means to be a responsible actor in biotechnology and biomanufacturing.