Opinion Paper By Patty Olinger, JM & Stefan Wagener, PhD
Biosafety and biosecurity are essential components of modern laboratory operations, ensuring that safety and security are seamlessly integrated into daily practices. Far from being burdensome, a well-implemented biorisk management system empowers laboratories through a top management-driven approach to continual improvement, based on clear internal and external stakeholder-based policies and objectives that are monitored and assessed through key performance indicators. When possible, these measures should be embedded into workflows so effectively that they become part of day-to-day activities or culture. Such a system ensures that resources are directed toward addressing gaps, continually improving biosafety and biosecurity and fostering the integrity of research. This results in scientists taking ownership of biorisk management and focusing better on their core mission—innovative science. Moreover, a comprehensive biorisk management system extends benefits beyond the facility, safeguarding communities and the environment and rebuilding public trust with transparency and external stakeholder input.
these measures should be embedded into workflows so effectively that they become part of day-to-day activities or culture
Biorisk Management System as an Efficiency Booster
A properly designed and implemented biorisk management system enhances safety, security, performance, and efficiency by optimizing laboratory workflows through continual improvement. By embedding performance-based safety and security measures into daily operations, laboratories can:
- Minimize Disruptions: Proactively addressing risks through comprehensive risk assessments and mitigation plans reduces the likelihood of incidents that disrupt research activities. This ensures continuity in experiments and prevents costly delays.
- Free Scientists to Focus on Science: An effective biorisk management system establishes a well-structured framework that streamlines compliance processes, enabling researchers to focus on their scientific work without compromising safety. By fostering a culture of ownership and pride in biosafety and biosecurity, such systems ensure critical infrastructure—such as biosafety cabinet maintenance, biohazardous waste management, and occupational health programs—is properly managed. This shared responsibility reduces administrative burdens, allowing scientists to dedicate more time to research and innovation at the bench.
- Target Resources Strategically: A biorisk management system provides for data-driven, measurable insights that help proactively identify and prioritize gaps in laboratory biosafety and biosecurity. This ensures that, for example, investments in equipment, training, and infrastructure are directed to areas where they are most needed and have the most significant impact, optimizing resource allocation and enhancing overall efficiency and improvement.
Protecting People, Research, Communities, and the Environment
At its core, biorisk management (the management of risks associated with biological materials) is about protection—of people, research, institutional reputation, and the broader community. Laboratories deal with a wide array of biological materials, some of which pose significant risks if mishandled or misused. However, at this point, laboratory biosafety and biosecurity are regulatory-driven and require a compliance-based program. While this approach has been well established, it has inherent weaknesses and will ultimately always be limited. Any and all compliance-based health, safety and security programs are only the bare minimum “standard,” and the latest data published by the Public Health Agency of Canada about laboratory accidents and incidents only demonstrate this weakness. In addition, the COVID-19 lab release discussion, the lack of transparency around “gain of function” research and the concern around potential pandemic pathogen work in laboratories, combined with laboratory accidents involving infectious agents, have caused a significant drop in public trust in infectious disease science. This will have potentially far-reaching decisions on science. Trying to regulate infectious disease research and science even more means trying to do the same thing over and over again and expecting different results, which will not happen. At this point, laboratories need to adopt a new strategy and approach that not only meets regulatory requirements, but also puts the ownership where it belongs, with laboratory management and staff. There is a reason why ISO-based management systems are successful: they are managed and owned by “management” and foster a culture of continual improvement. Biorisk management is beneficial for all laboratories and research facilities; however, implementing ISO 35001:2019 should be established as the baseline standard for all high-containment laboratories both nationally and internationally.
laboratories need to adopt a new strategy and approach that not only meets regulatory requirements, but also puts the ownership where it belongs
A robust biorisk management system framework ensures:
- Safety of Personnel: ISO 35001:2019 implementation involves the whole organization by building trust, confidence and as such improving the biosafety and biosecurity culture owned by everyone in the laboratory. Continually improved biorisk mitigation will result in measurable reduction of accidental exposures, protecting the health and well-being of researchers, support staff, and the public.
- Security of Materials: By implementing management system-based biosecurity measures, laboratories mitigate the risks of theft, misuse, or unauthorized access to biological agents, safeguarding critical assets.
- Institutional Integrity: Demonstrating a biorisk management system culture and commitment to biosafety and biosecurity led by top management fosters trust among stakeholders, including funders, collaborators, and the public. This trust is essential for maintaining partnerships and securing future opportunities, while at the same time rebuilding public trust.
- Community and Environmental Protection: By preventing the release of harmful biological agents, a biorisk management system protects surrounding communities and ecosystems, ensuring the broader impact of laboratory operations is positive. At the same time, it involves transparency and public input.
Fostering Innovation Through Confidence
A secure and safe environment based on a management system approach is a fertile ground for innovation. When scientists can work without fear of accidents or breaches and fear-driven science restrictions, they are free to explore bold ideas and push the boundaries of discovery. A biorisk management system creates this environment by:
- Establishing Clear Boundaries: Well-defined safety and security protocols provide researchers with a framework within which they can operate confidently, knowing that risks are controlled.
- Encouraging Collaboration: Laboratories with a strong biorisk management system will be seen as leaders in their field, attracting collaborations and partnerships that drive innovation.
- Building Resilience: By preparing for potential risks proactively, laboratories can respond swiftly and effectively to emergencies, minimizing downtime and ensuring that critical research continues uninterrupted.
The Role of ISO 35001:2019
The importance of biorisk management is underscored by international standards such as ISO 35001, which provides a framework for managing biological risks in laboratories and related facilities. Adopting this standard not only ensures compliance but also promotes a culture of safety, security, and continuous improvement. Implementing a quality framework based on ISO 35001 provides a guide or roadmap for both management system implementation and the effectiveness and efficiency of program execution. It serves as a benchmark for excellence, helping laboratories align with global best practices while ensuring their biorisk management approach is both robust and practical in achieving their objectives. A biorisk management system is the next level up from a compliance based biorisk management “program” and needed for increased transparency, performance and international acceptability. Existing programs are not management systems, a common misconception within the current laboratory biosafety and biosecurity community.
A Shared Responsibility
Biorisk management is not a task for one individual or department—it is a shared responsibility that requires buy-in from every level of an organization. From leadership to bench scientists, everyone plays a role in fostering a culture of safety and security. When embraced as a collective effort, and implemented as a biorisk management system, it becomes second nature, seamlessly integrated into daily operations rather than perceived as an external imposition.
Conclusion
Far from being a distraction, a biorisk management system (e.g., based on ISO 35001:2019) is a cornerstone of laboratory excellence. It ensures that resources are used strategically, risks are proactively managed and minimized, and scientists remain focused on their primary mission. By embedding management system-based biosafety and biosecurity into the fabric of laboratory operations, institutions can protect their people, research, reputation, communities, and environment while fostering an environment of confidence, trust, innovation, and efficiency. When done correctly, biorisk management is not a burden but a powerful enabler of progress and discovery. Let’s move biorisk management to the next level with a comprehensive management system!
