PHWR Public Health Weekly Report

The Korea Disease Control and Prevention Agency (KDCA) designates pathogens requiring national management as high-risk pathogens (HRPs). It also undertakes biosafety management tasks related to the handling and storage of HRPs, such as permissions for the possession and importation of HRPs and reporting on the isolation and transfer of HRPs according to the Infectious Disease Prevention and Control Act (hereinafter referred to as the ‘Infectious Disease Prevention Act’) [1].

Since 2000, there have been increasing concerns regarding bioterrorism and emergence of novel infectious diseases. In particular, following the 2001 anthrax terrorist attacks in the United States, several other countries have strengthened pathogen management. In 2000, the Republic of Korea (ROK) introduced a national management system for infectious disease pathogens through a comprehensive revision of the Infectious Disease Prevention Act. Regulations on appropriate handling, storage, transfer, and disposal of pathogens were established to prevent external leakage of pathogens and to minimize potential risks to public health and to the environment, even when pathogens are used for research or diagnosis purposes.

In 2006, 32 infectious pathogens that could potentially pose a severe risk to public health if used for bioterrorism purposes or leaked outside owing to accidents were designated as HRPs. Thereafter, the HRP list was modified. Enterohemorrhagic Escherichia coli serotype O157 was excluded, and four types of HRPs, namely, Shigella dysenteriae type 1, Yellow fever virus, Western equine encephalitis virus, reconstructed 1918 influenza virus (2010); and Middle East respiratory syndrome coronavirus were included.

In July 2023, following a revision of the Enforcement Rule of the Infectious Disease Control and Prevention Act, Chapare virus, Lujo virus, and poliovirus were designated as HRPs; thereby, expanding the scope of HRPs subject to national safety management to 39 pathogens in total (Table 1) [2].

Table 1 High-risk pathogens list

○ Bacteria and fungi

1. Yersinia pestis

2. Bacillus anthracis (except for Bacillus anthracis sterne strain)

3. Clostridium botulinum

4. Francisella tularensis

5. Brucella melitencis, Brucella suis

6. Burkholderia mallei

7. Burkholderia pseudomallei

8. Shigella dysenteriae type 1

9. Chlamydia psittaci

10. Coxiella burnetii

11. Rickettsia prowazekii

12. Rickettsia rickettsii

13. Vibrio cholerae O1, O139

14. Coccidioides immitis, Coccidioides posadasii

○ Virus and prion

1. Cercopithecine herpesvirus 1, Herpes B virus

2. Crimean-Congo haemorrhagic fever virus

3. Eastern equine encephalitis virus

4. Ebola virus

5. Lassa virus

6. Marbug virus

7. Variola virus

8. Variola minor virus, Alastrim

9. Hendra virus

10. Monkeypox virus

11. Nipah virus

12. Rift Valley fever virus

13. South American haemorrhagic fever virus; Flexal, Guanarito, Junin, Machupo, Sabia

14. Yellow fever virus

15. Western equine encephalitis virus

16. Tick-borne encephalitis complex virus; Central European Tick-born encephalitis, Far Eastern Tick-born encephalitis, Siberian Tick-born encephalitis, Kyasanur Forest disease, Omsk haemorrhagic fever virus

17. Venezuelan equine encephalitis virus

18. Severe Acute Respiratory Syndrome coronavirus (SARS-CoV)

19. Avian Influenza virus serotype H5N1, H7N7, H7N9 derived from human (except for vaccine candidate strains recognized by WHO)

20. Reconstructed forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (reconstructed 1918 influenza virus)

21. Transmission of spongiform encephalopathy agent; Bovine spongiform encephalopathy prion, variant Creutzfeldt-Jakob disease prion

22. Middle East Respiratory Syndrome coronavirus (MERS-CoV)

23. Chapare virus

24. Lujo virus

25. Poliovirus (except for vaccine strain Sabin types 1, 2, 3, and vaccine strains approved WHO)

○ Pathogens designated and announced by the Ministry of Health and Welfare as bacteria, fungi, viruses or prions that pose a significant risk to public health and require urgent management

Data from the Enforcement Rules of Ministry of Health and Welfare of the Republic of Korea (Enforcement Rule of the Infectious Disease Control and Prevention Act no. 1038) [2]..

Chapare virus and Lujo virus are hemorrhagic fever viruses that had not previously been managed as HRPs among the Risk Group 4 pathogens initially identified. However, given that the associated hazard level is high, the need for safety management was raised when handling or preserving these pathogens on entry into ROK owing to infection outbreaks elsewhere, or in relation to research and development, or for diagnostic purposes. Therefore, these viruses were additionally designated as HRPs. In 2012, the United States also added these two viruses to the Select Agent and Toxins list. Canada, Japan, and Singapore have designated these viruses as pathogens subject to special management and manage them in accordance with relevant laws [3,,-6].

Chapare virus is an arenavirus that causes Chapare hemorrhagic fever, an acute viral disease. This pathogen was first isolated in 2003 near the Chapare River in Cochabamba, Bolivia. It then re-emerged in 2019 in Karanabí, Bolivia, with human-to-human transmission confirmed through body fluids. It has a reported mortality rate of 67% (four of six infected individuals died) [7,8].

Lujo virus causes acute viral hemorrhagic fever, characterized as fever and nonspecific symptoms, which typically progress to hemorrhage and multiple organ failure. These presenting symptoms are similar to those of Lassa fever. In 2008, an outbreak of Lujo virus infections occurred in Lusaka, Zambia, and Johannesburg, South Africa, and four of the five infected individuals died [9]. This virus is the second arenavirus isolated in Africa after Lassa virus and was named the Lujo virus to reflect the first two letters of the two cities where the first infections occurred [10].

Poliovirus was included on the HRP list as a follow-up measure in preparation for the World Health Organization (WHO)’s Global Action Plan III for eradication certification. Since 2015, the WHO has been pursuing strategies to minimize biosafety risks related to poliovirus handling facilities following the eradication of wild poliovirus type (WPV) 1, 2, 3 and to phase out the oral poliovirus vaccine [11]. WPV2 and WPV3 were declared eradicated in 2015 and 2019, respectively, but case of WPV1 infection have been confirmed in Pakistan, Afghanistan, and in some African countries [12]. No cases of infection have been reported in ROK since 1984, and the country achieved the polio eradication status in 2000.

There is currently no treatment for poliomyelitis, and it can only be prevented through vaccination. In the case of oral vaccines, some attenuated vaccine viruses mutate during the process of replication in the intestine, after which they may regain neurotoxicity and circulate in the community, resulting in paralysis in some cases [13]. To eradicate such vaccine-derived poliomyelitis, new oral vaccine strains or inactivated vaccine strains that are genetically stable are needed. Therefore, poliovirus Sabin types 1, 2, 3, which can be used for research and development of novel vaccine strains, and viruses approved by the WHO for use as vaccine strains, were excluded from the HRP list.

The KDCA has continuously promoted improvements to the HRP safety management system. In consultation with the Pathogen Safety Management Division of the Health and Safety Expert Committee of the KDCA, it has reviewed the need to modify the HRP list and the appropriateness of pathogen candidates to be additionally designated; thereby, expanding the targets of HRPs requiring national management. The KDCA will continue to monitor pathogens and review the list of HRPs that require biosafety management in response to changing environments, such as the emergence of novel and variant pathogens and the need for international cooperation in pathogen management. Moreover, the KDCA plans to improve the HRP safety management system through establishment of appropriately targeted and efficient management measures in line with public demands for biosafety and biosecurity concerning HRPs safety management.

Ethics Statement: Not applicable.

Funding Source: None.

Acknowledgments: None.

Conflict of Interest: The authors have no conflicts of interest to declare.

Author Contributions: Conceptualization: JYL, KHO, JHS, TJS. Data curation: JYL. Investigation: JYL. Methodology: JYL. Project administration: KHO. Supervision: KHO, JHS, TJS. Writing – original draft: JYL. Writing – review & editing: KHO, JHS, TJS.