Building Biorisk Management Across Public Health Laboratories: A Collaboration with the National Authority for Containment of Poliovirus

The US Centers for Disease Control and Prevention (CDC) National Authority for Containment of Poliovirus (NAC) was created in 2018 to implement a poliovirus containment program focused on reducing the risk of accidental release from facilities handling or storing poliovirus. Public health laboratories contributed to the initial phase of containment by reporting poliovirus materials as part of the national inventory survey. A key component of this program is biorisk management and implementation of stringent laboratory biocontainment measures to ensure that poliovirus materials collected, tested, destroyed or transferred are handled within a safe, secure and controlled environment.

ISO 35001: Biorisk management for laboratories and other related organisations defines a process to manage the risks associated with biological agents like poliovirus and is built on the concept of continual improvement, supporting a structured process for identifying, evaluating and mitigating biological risks helping laboratories operate safely, securely and in compliance with regulatory requirements.

What Makes ISO 35001 Valuable? Offers a universal approach to identify and manage laboratory risk across various institutions Focuses on identifying, evaluating and mitigating biological hazards through a structured process Promotes continual improvement and integration of biosafety, biosecurity and quality management Supports regulatory compliance Builds culture of safety, trust and accountability at every organizational level

Public health laboratories act as the first line of defense by detecting, identifying and monitoring all types of biological threats. These institutions must be prepared to mitigate and contain these risks to ensure the safety of laboratory staff, the public and the environment. For example, in July 2022, a public health response was launched after a confirmed case of poliovirus was detected in New York. The response included enhanced surveillance and collection of samples potentially containing poliovirus at the Wadsworth Center. With public health laboratories potentially receiving poliovirus or potentially infectious material (PIM) in stool, respiratory secretions and wastewater samples, it is essential for these institutions to support heightened biorisk management practices including those outlined in ISO 35001.

APHL/CDC ISO 35001 Implementation Project

APHL, in collaboration with CDC, have developed a strategy to provide guidance and support public health laboratories towards ISO 35001 implementation. Through this collaboration, public health laboratories have successfully been able to identify and mitigate biosafety and biosecurity risks in the workplace to reduce incidents, accidents, infections and illnesses that can result from laboratory operations.

The project consists of:

• An initial site visit utilizing a gap analysis checklist to identify gaps in each institution’s processes related to biorisk management
• Virtual meetings to discuss and outline solutions towards ISO 35001 implementation
• Additional site visits and collaborations to review and support implementation steps

The project helps participating institutions turn the principles of the standard into practice. Participating laboratories receive customized guidance, subject matter expert consultation, peer support and resources to guide them toward ISO 35001 implementation. To this date, APHL has successfully piloted the implementation of ISO 35001 across four public health laboratories and is currently onboarding two additional laboratories for implementation in 2026.

2026 APHL Biorisk Management Trainings

APHL is planning an in-person training for public health laboratory biosafety professionals on biorisk management principles. The workshop will utilize lectures and exercises on key principles of biorisk management through interactive sessions.

This remote-based program is designed to connect biosafety, biosecurity and quality management under one cohesive framework outlined in ISO 35001. The program applies the Plan-Do-Check-Act methodology and high-reliability organization concepts from ISO 35001 to strengthen risk mitigation, learning and system-based corrective action.

Biorisk management practices outlined in ISO 35001 demonstrate an institution wide commitment to safety. APHL, in collaboration with NAC, will continue to promote and showcase the value of ISO 35001 practices across the public health laboratory community.

Contact [email protected] for more information on the APHL/CDC ISO 35001 Implementation Project or other biorisk management trainings.