PHWR Public Health Weekly Report

In 2000, the Republic of Korea began to manage infectious disease pathogens by establishing regulations on the inspection, preservation, and management of infectious disease pathogens via a revision of the Infectious Disease Prevention Act. Since the establishment of a safety management system for high-risk pathogens (HRPs), which are pathogens of infectious diseases that pose a serious threat to public health, in 2005, it is mandatory to report the isolation and transfer of HRPs to this system [1-3].

Thirty-six pathogens have been designated as HRPs under the Infectious Disease Control and Prevention (IDCP) Act. The IDCP Act outlines the precise steps for the isolation, possession, and transfer of HRPs to protect public health. The Korea Disease Control and Prevention Agency (KDCA) annually inspects the institutions possessing and handling HRPs to ensure regulatory compliance [1-3].

In 2010, an import permit system was implemented under the amended IDCP Act. In 2019, a possession permit system was established for eight infectious pathogens spread via bioterrorism (Bacillus anthracis, Clostridium botulinum, Yersinia pestis, Francisella tularensis, Ebola virus, Lassa virus, Marburg virus, and smallpox virus). In October (2021), biosafety management practices for HRPs were further strengthened via additional revisions, such as the provision of grounds for the revocation of permission to possess infectious pathogens spread via bioterrorism and import HRPs, and the establishment of regulations for the disposal of pathogens [1,3].

In 2022, even if institutions did not own HRP handling facilities, they were allowed to conduct research activities and import, examine, and possess HRPs after signing a contract for the use of HRP handling facilities to improve the diagnosis of infectious diseases and promote academic research. When the license of an HRP handling facility is revoked or it is ordered to close down, all pathogens owned by the facility must be destroyed. If necessary, the KDCA can seek expert opinions on such decisions [1,3].

On receiving an order to revoke the permit of or close down an HRP handling facility, all relevant information, including information on HRPs and their disposal process, should be reported to the KDCA within 10 days from the date of disposal. The enforcement regulations were later amended to provide specific methods and procedures for permit cancellation [1,3].

The KDCA raises the awareness of domestic researchers and ensures biosafety by providing guidelines on the handling requirements and possession of HRPs to promote safe handling practices, outlining biosecurity protocols for HRPs, and providing information on the biosafety, biosecurity, and training opportunities for researchers and other workers in relevant industries.

In the future, we plan to establish a practical and efficient safety management standard that meets the biosecurity and biosafety management requirements for HRPs by introducing and continuously improving the related laws and systems, such as the introduction of a differential management system for HRPs.

Acknowledgments: None.

Ethics Statement: Not applicable.

Funding Source: None.

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

Author Contributions: Conceptualization: HSS, JS. Data curation: YL. Investigation: YL. Methodology: JS. Project administration: JS. Supervision: HSS, JHS. Writing – original draft: YL. Writing – review & editing: HSS, JS.