Safety management of biosafety facilities

Report and permit for handling high-risk pathogen handling facilities

In accordance with the Infectious Disease Control and Prevention Act (“Infectious Disease Act”), individuals who wish to establish and operate a high-risk pathogen handling facility (“handling facility”) for handling high-risk pathogens (pathogens corresponding to the annex of the Enforcement Rules of the Infectious Disease Act) must obtain permission from or report to the Korea Disease Control and Prevention Agency based on the safety management grade of the handling facility.

Level 1
Facility that handles high-risk pathogens not known to cause disease in healthy adults, or that conducts experiments using such pathogens
Report
Level 2
Facility that handles high-risk pathogens capable of causing diseases that can be easily treated, even if they infect and cause illness in humans, or that conducts experiments using such pathogens
Report
Level 3
Facility that handles high-risk pathogens capable of causing diseases that can be fatal and difficult to treat if they infect and cause illness in humans, or that conducts experiments using such pathogens
Permit
Level 4
Facility that handles high-risk pathogens capable of causing diseases that can be serious but are treatable if they infect and cause illness in humans, or that conducts experiments using such pathogens
Permit

[고위험병원체 취급시설의 안전관리 등급의 분류 및 허가 또는 신고대상]

Laws related to the handling of high-risk pathogens

If a facility is operated without permission or notification, it may face suspension or closure.

According to the Act on the Control and Prevention of Infectious Diseases, any of the following may result in cancellation of permission, facility closure, and suspension of operation for up to one year.

Permission is obtained or reported through deceit or other fraudulent means (cancellation of permission or closure of high-risk pathogen handling facilities)
The contents of the permission or notification are changed without obtaining a modification permit or making a modification report for an approved facility
The facility falls short of the permit or notification standards
The safety management compliance requirements are not followed

Penalties

According to Article 79 (2-2) of the Act (Penalties), individuals who install or operate high-risk pathogen handling facilities without reporting may face imprisonment of up to 2 years or a fine of up to 20 million won.
According to Article 83 (1) of the Act (Fines), a fine of up to 10 million won shall be imposed on individuals who fail to make a modification report.
According to Article 83 (1) of the Act (Fines), a fine of up to 10 million won shall be imposed on individuals who fail to make a closure report.

Reporting and Permitting of Biosafety Research Facilities

Individuals who wish to install and operate facilities (“research facilities”) that develop or conduct experiments using living modified organisms (LMOs) as defined by the Transboundary Movement, Etc. of Living Modified Organisms Act (“LMO Act”) must obtain permission from the Korea Disease Control and Prevention Agency according to the safety management grade of the research facility (for human hazard living modified organisms) or report to the Ministry of Health and Welfare (public institutions under its jurisdiction).

Level 1
Facilities that develop or conduct experiments using living modified organisms not known to cause disease in healthy adults, or to pose a risk to the environment
Report
Level 2
Facilities that develop or conduct experiments using living modified organisms that can cause diseases that are easily treatable in humans, and living modified organisms that pose minor risks to the environment which are easily remedied if released
Report
Level 3
Facilities that develop or conduct experiments using living modified organisms that can cause symptoms in humans that are serious but treatable, and living modified organisms that may pose significant risks to the environment if released but are remedial
Permit
Level 4
Facilities that develop or conduct experiments using living modified organisms that can cause fatal symptoms in humans which are difficult to treat, as well as living modified organisms that pose enormous risks to the environment if released and are hard to remedy
Permit

[연구시설의 안전관리등급의 분류 및 허가 또는 신고 대상]

Laws related to biosafety research facilities

If a research facility is operated without permission or reporting, it may face suspension and closure orders, including in the following cases.

Where permission is obtained or a report is filed using deception or other fraudulent methods
Where the contents of the permit or report are changed without obtaining modification permission or making a modification report for the permitted research facility
Where the facility falls short of the permit or notification standards
Where the safety management compliance requirements are not followed

Penalties

According to Article 41 (4) of the Act (Penalties), individuals who install and operate research facilities without reporting may face imprisonment of up to 2 years or a fine of up to 30 million won.
According to Article 44 (7) of the Act (Fines), a fine of up to 10 million won shall be imposed on individuals who fail to make a modification report
According to Article 44 (7) of the Act (Fines), a fine of up to 10 million won shall be imposed on individuals who fail to make a closure report.