Abstract
In recognition of Applied Biosafety’s 30th anniversary, this expanded Special Issue on Biosafety and Biosecurity for Pathogens with Enhanced Pandemic Potential (PEPP) and Dual-Use Research of Concern (DURC) addresses the increased complexity and challenges faced by the research, biomedical, and national security communities. It provides a platform to bridge the gap between policy and practice. It promotes a multidisciplinary dialogue by bringing together perspectives from biosafety practitioners, microbiologists, public health officials, clinicians, policymakers, ethicists, and legal experts to shape future governance structures for PEPP and DURC research.
By soliciting contributions on risk assessment frameworks, regulatory oversight models, and best practices in biosafety and biosecurity, this Special Issue offers a proactive and forward-looking approach to policy development. Such an approach is essential for building adaptive agility to address the growing spectrum of biological threats and biosafety challenges, from novel and reemerging pathogens to the anticipated rise in zoonotic diseases driven by anthropogenic disruptions. It also considers the increasing geopolitical tensions over commercial and military interests in biotechnology, artificial intelligence, and other emerging dual-use technologies. As the global biosafety community navigates these challenges, this Special Issue provides a timely forum to explore solutions for safeguarding scientific progress and public health.
Two review articles provide the foundation for this issue. Gillum surveys the landscape of significant events and policy developments shaping biosafety and biosecurity and provides potential frameworks that incorporate ethical, political, and regulatory perspectives on DURC and PEPP governance. His article highlights the ongoing challenge of balancing research innovation with safety and security and promotes adaptable governance systems to manage emerging risks without unnecessarily impeding scientific discovery. Epstein examines the evolution of oversight policies for high-consequence research, particularly gain-of-function studies, and identifies key gaps in current governance. These include the lack of oversight for privately funded research and the omission of safeguards for research that may artificially create novel pandemic pathogens.
Following these reviews, a set of commentaries further unpacks the 2024 U.S. government policy on DURC and PEPP and its implications for high-risk biological research. Lipsitch points out that under the new framework, responsibility for risk assessment remains with principal investigators. However, he argues that a set of mutually reinforcing preconditions not fully specified in the policy is necessary for successful implementation. Imperiale critiques the vague and subjective criteria used to determine when oversight is needed and recommends that research intent serve as the central triage point. He states, “If the intent is to deliberately create an infectious agent with enhanced virulence or transmissibility, then it should automatically be triaged for serious review.” Building on these concerns, Chan advocates for creating an independent regulatory organization responsible for inspecting, overseeing, and reviewing PEPP research, regardless of funding source.
While the 2024 U.S. policy remains focused on federally funded research, several commentaries emphasize its global implications. Dousse and Summermatter provide a Swiss perspective, suggesting that U.S. standards could serve as a template for broader international harmonization. In Singapore, Lim argues that while the policy is a step forward, its impact in Asia will depend on local contexts and institutional capacities. Adding to this regional lens, Singaporean contributors Caballero-Anthony et al. analyze DURC governance across Southeast Asia. Their commentary is further supported by Vengadesen et al., who explore the lack of DURC elements in Malaysian biosafety guidelines and advocate for integrating dual-use principles into national frameworks.
European-based authors, including Sharma et al., compare the U.S. policy to Canada’s DURC framework. Echoing other commentaries, they advocate for extending oversight beyond federally funded research, developing more straightforward risk assessment guidelines, and enhancing scientific communication policies. Meanwhile, Magne and colleagues from the United Kingdom stress the importance of education in promoting responsible research. They introduce a new initiative, the International Biological Security Education Network, to strengthen global biosecurity awareness and align educational efforts across countries and institutions.
Rounding out the commentaries is a personal contribution by Moritz, who provides a behind-the-scenes account of managing a nationally visible, ethically complex case involving PEPP and DURC. Her reflection highlights the essential role of cross-disciplinary collaboration and institutional support. As she notes, “A biosafety professional cannot be effective in a silo. Building a top-notch infrastructure to support an institution’s research enterprise takes subject matter experts from multiple different arenas who all have the same goal—a vested interest in the safety and security of the research and its researchers.”
The original articles included in this issue address key aspects of DURC and PEPP oversight and management. Hurst and Bobier use Google Scholar Metrics and Scimago Journal and country rank to evaluate the editorial policies of top life sciences and AI journals regarding dual-use research. They find that roughly half of life sciences journals have relevant policies, compared to only 22 percent of AI journals, demonstrating the urgent need for editorial standards in technology-oriented fields.
Snyder and colleagues apply a “just culture” approach borrowed from high-reliability sectors like aviation to biological risk management. They identify four key elements of this model and explore its practical challenges, emphasizing the need for organizational commitment and transparency. Green and colleagues report on a survey of scientists at a major U.S. university. While most researchers believed they were responsible for biosafety, few considered dual-use risks or the potential for intentional misuse. Their findings suggest the need for broader training and policies that do not overburden researchers with unnecessary administrative tasks.
Walsh and Gronvall present interviews with virologists about their perceptions of the risks and opportunities presented by AI in virology. Their commentary highlights the lack of consensus and the pressing need for guidance on applying AI tools while maintaining strong biosafety and biosecurity standards.
A particularly timely contribution comes from Spackman et al., who describe research conducted in an ABSL 3Ag facility to assess whether continuous flow pasteurization can inactivate highly pathogenic avian influenza virus (HPAIV) in milk. Their study was prompted by recent discoveries of widespread HPAIV infection in U.S. cattle and the detection of high virus concentrations in milk. Their experiments with 80 liters of virus-spiked milk confirmed that the pasteurization process effectively inactivated the virus, ensuring its safety for human consumption. The authors emphasize that despite the urgency of such research, rigorous experimental design, comprehensive review by biosafety committees, and expert involvement throughout the research process remain critical.
The expert perspectives in this issue highlight the complexity of governing high-risk biological research and the critical need for clear and ideally harmonized policies supported by robust oversight and ongoing review to allow timely updates. As the complexity of the life sciences research landscape continues to grow in response to urgent global health challenges, the importance of interdisciplinary collaboration, open dialogue for information exchange, and investment in infrastructure and education to mitigate risks from error, accident, or intentional misuse cannot be overstated.