Containment Guidance for Facilities
Poliovirus containment is a key objective of the World Health Organization’s (WHO) Global Polio Eradication Initiative. The U.S. National Authority for Containment of Poliovirus (NAC) helps reduce the risk of polioviruses being released from the places where they are worked with or stored. The NAC is responsible for implementing the containment plan in the U.S.
Facilities (e.g., public health laboratories, vaccine producers, research laboratories, clinical laboratories, storage facilities, environmental testing laboratories) that may collect, use, or store polioviruses serve critical national and international functions. They perform critical research, vaccine development and manufacturing, clinical and environmental testing.
Facilities that knowingly or unknowingly collect, use, or store poliovirus infectious materials (IM) and potentially infectious materials (PIM) samples (e.g., stool, respiratory secretion, concentrated sewage, wastewater) pose a risk for re-introduction of poliovirus into communities after eradication.
In support of global containment efforts, the NAC is responsible for maintaining a national inventory of facilities and providing oversight for safe use or storage of these materials. The NAC works with facilities to implement containment strategies and follow guidance in accordance with WHO Global Action Plan (GAPIV).
- Identify: All facilities will conduct a survey to identify infectious and potentially infectious poliovirus materials.
- Destroy: Facilities will destroy (or inactivate) all unneeded or nonessential poliovirus materials.
- Transfer: Facilities may need to move samples and scientifically valuable poliovirus materials to poliovirus-essential facilities.
- Contain: Facilities retaining any eradicated materials will need to be designated as “poliovirus-essential” facilities (PEFs). These facilities must comply with the World Health Organization Global Action Plan, fourth edition (GAPIV).
Facilities identify and report poliovirus infectious and potentially infectious materials to NAC using an electronic survey. Facilities that test, extract, handle, or store polioviruses and biological samples from humans, experimentally infected animals, sewage, or environmental waters (e.g., wastewater) should complete the survey.
To determine if you possess infectious (IM) or potentially infectious materials (PIM), refer to the definitions and examples.
If you think you may have poliovirus IM or PIM, please email email@example.com
Facilities are strongly encouraged to destroy all samples containing or potentially containing poliovirus that are not deemed essential using a method validated to inactivate poliovirus. Preferred methods of destruction are autoclave or incineration.
Nucleic acid extraction methods often require modification to fully inactivate poliovirus (Honeywood et. al (2021): J Virol Methods. 297:114262. PMID: 34384823 https://pubmed.ncbi.nlm.nih.gov/34384823/ ).
Non-poliovirus essential facilities can retain nucleic acids extracted using methods validated to inactivate poliovirus under certain conditions.
Facilities must report all transfers of poliovirus materials, including extracted nucleic acids, to NAC. For poliovirus materials subject to GAPIV containment, facilities must only transfer these materials to a registered PEF for storage or additional analysis. Facilities must coordinate transfer agreements with the PEF for scientifically valuable samples before shipment.
Facilities that retain polioviruses and potentially infectious materials must contain these materials. GAPIV defines the facility roles and responsibilities for containment. All facilities that continue to handle or store polioviruses require certification as a PEF in accordance with timelines established by GAPIV. Facilities that retain poliovirus PIM must implement containment measures indicated in the WHO PIM Guidance.
Click here for more information and interim guidance for containment in areas with ongoing poliovirus circulation
Poliovirus-Essential Facilities (PEF)
A PEF is a facility that maintains the ability to work with and/or store infectious and potentially infectious poliovirus materials. These facilities serve critical national and international functions. They perform critical research, vaccine development and manufacturing, clinical and environmental testing.
Facilities performing these functions are limited in number and must implement stringent biorisk management controls for all of the elements outlined in GAPIV. These elements include increased biosafety and security measures over the current Biosafety in Microbiological and Biomedical Laboratories, 6th Ed. (BMBL) BSL-2/ABSL-2 recommendations.
The process for becoming a PEF is in the Containment Certification Scheme (CCS). PEFs must participate in the national survey, apply for containment certification, and implement the GAPIV standard and NAC policies.
For more information on Poliovirus Containment in the U.S. and how to become a PEF, please email firstname.lastname@example.org.