{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T08:44:38Z","timestamp":1765183478571,"version":"3.46.0"},"reference-count":56,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T00:00:00Z","timestamp":1764979200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>As the world approaches wild poliovirus eradication, effective containment measures are essential to minimize the risk of a facility-associated reintroduction into a polio-free community. Between 2017 and 2024, the United States established a national authority for containment (NAC) of poliovirus to maintain a national inventory of poliovirus materials and designate facilities to retain polioviruses. Countries with designated facilities are expected to maintain primary, secondary, and tertiary safeguards for facility containment certification. Primary safeguard requirements are assessed through audits following an ISO risk-based process. Standardized data collection and reporting tools were developed in Microsoft Access, and data were analyzed using SAS\u00ae 9.4 and R software (version 4.4.3). The NAC conducted 16 audits in three categories: gap assessment (n = 10), Stage 1 audit (n = 3), and Stage 2 audit (n = 3). The NAC found that conformance to the containment standard improved among audit categories (\u03c72 = 94.6, 2 df, p-value &lt; 0.0001). In 2024, five audits were conducted according to the revised poliovirus containment standard. Notable gaps were identified in system elements associated with risk assessment, clothing and personal protective equipment, accident\/incident, and decontamination\/inactivation procedures. Despite compliance with secondary and tertiary requirements, several primary containment elements continue to pose a challenge for facilities, resulting in no US-designated facility achieving full certification.<\/jats:p>","DOI":"10.3390\/pathogens14121250","type":"journal-article","created":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T08:21:43Z","timestamp":1765182103000},"page":"1250","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Implementation of Poliovirus Containment in Poliovirus Designated Facilities\u2014United States, 2017\u20132024"],"prefix":"10.3390","volume":"14","author":[{"given":"Christy","family":"Ottendorfer","sequence":"first","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9462-7733","authenticated-orcid":false,"given":"Patrick","family":"Vander Kelen","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7395-7335","authenticated-orcid":false,"given":"Cecelia A.","family":"Sanders","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Watson","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"},{"name":"Oak Ridge Institute for Science and Education, Oak Ridge, TN 37831, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suganthi","family":"Suppiah","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4062-3093","authenticated-orcid":false,"given":"William","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Applied Science, Research & Technology, Inc., Smyrna, GA 30080, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colby","family":"Sinclair","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"},{"name":"Oak Ridge Institute for Science and Education, Oak Ridge, TN 37831, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Abena","family":"Marfo","sequence":"additional","affiliation":[{"name":"Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA 30322, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lia","family":"Haynes Smith","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,12,6]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"441","DOI":"10.15585\/mmwr.mm7319a4","article-title":"Progress Toward Poliomyelitis Eradication\u2014Worldwide, January 2022\u2013December 2023","volume":"73","author":"Geiger","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1330","DOI":"10.15585\/mmwr.mm6937a7","article-title":"Progress Toward Poliovirus Containment Implementation\u2014Worldwide, 2019\u20132020","volume":"69","author":"Moffett","year":"2020","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1363","DOI":"10.3201\/eid2507.181703","article-title":"Facility-Associated Release of Polioviruses into Communities-Risks for the Posteradication Era","volume":"25","author":"Bandyopadhyay","year":"2019","journal-title":"Emerg. Infect. Dis."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"855","DOI":"10.1126\/science.419409","article-title":"Smallpox death in Britain challenges presumption of laboratory safety","volume":"203","author":"Hawkes","year":"1979","journal-title":"Science"},{"key":"ref_5","first-page":"425","article-title":"Smallpox and its post-eradication surveillance","volume":"65","author":"Jezek","year":"1987","journal-title":"Bull. World Health Organ."},{"key":"ref_6","unstructured":"World Health Organization (1999). WHO Global Action Plan for Laboratory Containment of Wild Polioviruses, World Health Organization."},{"key":"ref_7","unstructured":"World Health Organization (2015). WHO Global Action Plan to Minimize Poliovirus Facility-Associated Risk After Type-Specific Eradication of Wild Polioviruses and Sequential Cessation of Oral Polio Vaccine Use\u2014GAPIII, World Health Organization. [3rd ed.]."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"934","DOI":"10.15585\/mmwr.mm6535a3","article-title":"Cessation of Trivalent Oral Poliovirus Vaccine and Introduction of Inactivated Poliovirus Vaccine\u2014Worldwide, 2016","volume":"65","author":"Hampton","year":"2016","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Ottendorfer, C., Shelby, B., Sanders, C.A., Llewellyn, A., Myrick, C., Brown, C., Suppiah, S., Gustin, K., and Smith, L.H. (2024). Establishment of a Poliovirus Containment Program and Containment Certification Process for Poliovirus-Essential Facilities, United States 2017\u20132022. Pathogens, 13.","DOI":"10.20944\/preprints202401.0595.v1"},{"key":"ref_10","unstructured":"(2008). Laboratory Biorisk Management Standard (Standard No. CWA 15793:2008)."},{"key":"ref_11","unstructured":"(2019). Biorisk Management for Laboratories and Other Related Organisations (Standard No. ISO35001:2019)."},{"key":"ref_12","unstructured":"World Health Organization (2022). WHO Global Action Plan for Poliovirus Containment\u2014GAPIV, World Health Organization. [4th ed.]."},{"key":"ref_13","unstructured":"World Health Organization (2025, April 10). Country Progress Towards Poliovirus Containment Certification. Available online: https:\/\/polioeradication.org\/what-we-do-2\/containment\/."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"114262","DOI":"10.1016\/j.jviromet.2021.114262","article-title":"Use of guanidine thiocyanate-based nucleic acid extraction buffers to inactivate poliovirus in potentially infectious materials","volume":"297","author":"Honeywood","year":"2021","journal-title":"J. Virol. Methods"},{"key":"ref_15","unstructured":"Global Polio Eradication Initiative (GPEI) (2022). Global Poliovirus Containment Action Plan 2022\u20132024, World Health Organization."},{"key":"ref_16","unstructured":"(2015). Quality Management Systems\u2014Requirements (Standard No. ISO9001:2015)."},{"key":"ref_17","unstructured":"(2015). ISO\/IEC TS 17021-1:2015 Conformity Assessment\u2014Requirements for Bodies Providing Audit and Certification of Management Systems (Standard No. ISO\/IEC TS 17021)."},{"key":"ref_18","unstructured":"(2018). Guidelines for Auditing Management Systems (Standard No. ISO19011:2018)."},{"key":"ref_19","unstructured":"(2018). Occupational Health and Safety Management Systems\u2014Requirements with Guidance for Use (Standard No. ISO 45001:2018)."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"3078","DOI":"10.1111\/trf.15018","article-title":"Progress of polio eradication and containment requirements after eradication","volume":"58","author":"Oberste","year":"2018","journal-title":"Transfusion"},{"key":"ref_21","unstructured":"International Accreditation Forum (2023). Determination of Audit Time of Quality, Environmental, and Occupational Health & Safety Management Systems, International Accreditation Forum."},{"key":"ref_22","first-page":"1","article-title":"Poliomyelitis prevention in the United States. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP)","volume":"49","author":"Prevots","year":"2000","journal-title":"MMWR Recomm. Rep."},{"key":"ref_23","unstructured":"Centers for Disease Control and Prevention (CDC) (2025, March 06). Polio Vaccination Coverage Among Children 19\u201335 Months by State, HHS Region, and the United States, National Immunization Survey-Child (NIS-Child), 1995 Through 2021, Available online: https:\/\/www.cdc.gov\/vaccines\/imz-managers\/coverage\/childvaxview\/interactive-reports\/index.html."},{"key":"ref_24","unstructured":"United States Environmental Protection Agency (US EPA) (2025, March 06). Clean Water Act, Federal Water Pollution Control Amendments, Available online: https:\/\/www.epa.gov\/laws-regulations\/summary-clean-water-act."},{"key":"ref_25","unstructured":"United States Environmental Protection Agency (US EPA) (2025, March 06). NPDES Municipal Wastewater Program, Available online: https:\/\/www.epa.gov\/npdes\/municipal-wastewater."},{"key":"ref_26","unstructured":"SAS Institute Inc (SAS Software, 2020). SAS Software, version 9.4."},{"key":"ref_27","unstructured":"R Core Team (2024). R: A Language and Environment for Statistical Computing, R Foundation for Statistical Computing."},{"key":"ref_28","unstructured":"U.S. Department of Health and Human Services (2025, December 02). Biosafety in Microbiological and Biomedical Laboratories (BMBL), Available online: https:\/\/www.cdc.gov\/labs\/media\/pdfs\/2025\/08\/SF__19a_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf."},{"key":"ref_29","unstructured":"World Health Organization (2024). Summary Report from the Twenty-Fourth Meeting of the Global Commission for Certification of Poliomyelitis Eradication, World Health Organization."},{"key":"ref_30","doi-asserted-by":"crossref","unstructured":"Marcet, P.L., Short, B., Deas, A., Sun, H., Harrington, C., Shaukat, S., Alam, M.M., Baba, M., Faneye, A., and Namuwulya, P. (2025). Advancing poliovirus eradication: Lessons learned from piloting direct molecular detection of polioviruses in high-risk and priority geographies. Microbiol. Spectr., 13.","DOI":"10.1128\/spectrum.02279-24"},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"909","DOI":"10.15585\/mmwr.mm7341a1","article-title":"Update on Vaccine-Derived Poliovirus Outbreaks\u2014Worldwide, January 2023\u2013June 2024","volume":"73","author":"Greene","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"122","DOI":"10.15585\/mmwr.mm7407a4","article-title":"Notes from the Field: Detection of Vaccine-Derived Poliovirus Type 2 in Wastewater\u2014Five European Countries, September-December 2024","volume":"74","author":"Huseynov","year":"2025","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1016\/j.cmi.2024.10.003","article-title":"Poliomyelitis in Gaza","volume":"31","author":"Gupta","year":"2025","journal-title":"Clin. Microbiol. Infect."},{"key":"ref_34","unstructured":"World Health Organization (2025, December 02). World Health Assembly Resolution 71.16: Poliomyelitis\u2014Containment of Polioviruses. Available online: https:\/\/apps.who.int\/gb\/ebwha\/pdf_files\/WHA71\/A71_R16-en.pdf."},{"key":"ref_35","doi-asserted-by":"crossref","unstructured":"Jeannoel, M., Antona, D., Lazarus, C., Lina, B., and Schuffenecker, I. (2020). Risk Assessment and Virological Monitoring Following an Accidental Exposure to Concentrated Sabin Poliovirus Type 3 in France, November 2018. Vaccines, 8.","DOI":"10.3390\/vaccines8020331"},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"2300049","DOI":"10.2807\/1560-7917.ES.2023.28.5.2300049","article-title":"Wild poliovirus type 3 (WPV3)-shedding event following detection in environmental surveillance of poliovirus essential facilities, the Netherlands, November 2022 to January 2023","volume":"28","author":"Duizer","year":"2023","journal-title":"Euro Surveill."},{"key":"ref_37","unstructured":"U.S. Government Publishing Office (2025, December 02). Electronic Code of Federal Regulations Title 42 Chapter 1 Subchapter F Part 73, Available online: https:\/\/www.ecfr.gov\/current\/title-42\/chapter-I\/subchapter-F\/part-73."},{"key":"ref_38","unstructured":"Centers for Disease Control and Prevention (CDC) (2004). National laboratory inventory for global poliovirus containment\u2014United States, November 2003. MMWR Morb. Mortal. Wkly. Rep., 53, 457\u2013459."},{"key":"ref_39","unstructured":"Centers for Disease Control and Prevention (CDC) (2006). National laboratory inventory for global poliovirus containment\u2014European Region, June 2006. MMWR Morb. Mortal. Wkly. Rep., 55, 916\u2013918."},{"key":"ref_40","unstructured":"Centers for Disease Control and Prevention (CDC) (2010). Completion of national laboratory inventories for wild poliovirus containment\u2014Region of the Americas, March 2010. MMWR Morb. Mortal. Wkly. Rep., 59, 985\u2013988."},{"key":"ref_41","unstructured":"Centers for Disease Control and Prevention (CDC) (2009). National laboratory inventories for wild poliovirus containment\u2014Western Pacific region, 2008. MMWR Morb. Mortal. Wkly. Rep., 58, 975\u2013978."},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"913","DOI":"10.15585\/mmwr.mm6433a5","article-title":"World Health Organization Guidelines for Containment of Poliovirus Following Type-Specific Polio Eradication\u2014Worldwide, 2015","volume":"64","author":"Previsani","year":"2015","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_43","doi-asserted-by":"crossref","unstructured":"Bassey, B.E., Braka, F., Shuaib, F., Banda, R., Tegegne, S.G., Ticha, J.M., Abdullalhi, W.H., Kolawole, O.M., and Kabir, Y. (2018). Distribution pattern of poliovirus potentially infectious materials in the phase 1b medical laboratories containment in conformity with the global action plan III. BMC Public Health, 18.","DOI":"10.1186\/s12889-018-6183-1"},{"key":"ref_44","unstructured":"World Health Organization (2025, December 02). Seventy Fifth World Health Assembly: Poliomyelitis: Poliomyelitis Eradication Report. Available online: https:\/\/apps.who.int\/gb\/ebwha\/pdf_files\/WHA75\/A75_23-en.pdf."},{"key":"ref_45","doi-asserted-by":"crossref","first-page":"788","DOI":"10.15585\/mmwr.mm7336a2","article-title":"Progress Toward Poliomyelitis Eradication\u2014Pakistan, January 2023\u2013June 2024","volume":"73","author":"Mbaeyi","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_46","doi-asserted-by":"crossref","first-page":"1129","DOI":"10.15585\/mmwr.mm7349a4","article-title":"Progress Toward Poliomyelitis Eradication\u2014Afghanistan, January 2023\u2013September 2024","volume":"73","author":"Hardy","year":"2024","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_47","unstructured":"United States Government White House (2025, December 02). Withdrawing the United States from the World Health Organization, Available online: https:\/\/www.federalregister.gov\/documents\/2025\/01\/29\/2025-01957\/withdrawing-the-united-states-from-the-world-health-organization."},{"key":"ref_48","doi-asserted-by":"crossref","first-page":"S36","DOI":"10.1089\/bsp.2013.0020","article-title":"Harmonization of European laboratory response networks by implementing CWA 15793: Use of a gap analysis and an \u201cinsider\u201d exercise as tools","volume":"11","author":"Sundqvist","year":"2013","journal-title":"Biosecur. Bioterror."},{"key":"ref_49","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1089\/hs.2021.0163","article-title":"A Call for a National Agency for Biorisk Management","volume":"20","author":"Ritterson","year":"2022","journal-title":"Health Secur."},{"key":"ref_50","doi-asserted-by":"crossref","first-page":"376","DOI":"10.1089\/hs.2022.0074","article-title":"Concepts to Bolster Biorisk Management","volume":"20","author":"Dettmann","year":"2022","journal-title":"Health Secur."},{"key":"ref_51","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1089\/apb.20.0068","article-title":"Considerations for Laboratory Biosafety and Biosecurity During the Coronavirus Disease 2019 Pandemic: Applying the ISO 35001:2019 Standard and High-Reliability Organizations Principles","volume":"26","author":"Callihan","year":"2021","journal-title":"Appl. Biosaf."},{"key":"ref_52","unstructured":"Rengarajan, K. (2013, January 17\u201323). The implementation of a biorisk management system (CWA 15793:2008) and process improvement using an A\/BSL-3 research project as a model system. Proceedings of the 56th Annual Biosafety and Biosecurity Conference, Kansas City, MO, USA."},{"key":"ref_53","unstructured":"Kembi, F. (2024, January 1\u20136). Biorisk Management Implementation in Select Public Health Laboratories Across the U.S. Proceedings of the 67th Annual Biosafety and Biosecurity Conference, Phoenix, AZ, USA."},{"key":"ref_54","doi-asserted-by":"crossref","unstructured":"Lestari, F., Kadir, A., Miswary, T., Maharani, C.F., Bowolaksono, A., and Paramitasari, D. (2021). Implementation of Bio-Risk Management System in a National Clinical and Medical Referral Centre Laboratories. Int. J. Environ. Res. Public Health, 18.","DOI":"10.3390\/ijerph18052308"},{"key":"ref_55","doi-asserted-by":"crossref","first-page":"441","DOI":"10.1007\/978-1-0716-2111-0_24","article-title":"Biorisk Management for SARS-CoV-2 Research in a Biosafety Level-3 Core Facility","volume":"2452","author":"Joseph","year":"2022","journal-title":"Methods Mol. Biol."},{"key":"ref_56","doi-asserted-by":"crossref","first-page":"2000089","DOI":"10.2807\/1560-7917.ES.2020.25.36.2000089","article-title":"Assessment of biorisk management systems in high containment laboratories, 18 countries in Europe, 2016 and 2017","volume":"25","author":"Appelt","year":"2020","journal-title":"Euro Surveill."}],"container-title":["Pathogens"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2076-0817\/14\/12\/1250\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,8]],"date-time":"2025-12-08T08:39:53Z","timestamp":1765183193000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2076-0817\/14\/12\/1250"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,6]]},"references-count":56,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["pathogens14121250"],"URL":"https:\/\/doi.org\/10.3390\/pathogens14121250","relation":{},"ISSN":["2076-0817"],"issn-type":[{"value":"2076-0817","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,6]]}}}