Botulinum Toxin is poorly managed

Illegal acquisition and poor security

A full investigation into the management status of 24 domestic botulinum toxin institutions

Poor management of some domestic botulinum strains has been detected.

 

Illegal circumstances have also been detected, including analysis of strains' sources and characteristics, security management of fungus handlers, illegal acquisition of strains, and suspected cases of false separation reports.

 

Authorities are planning to jointly come up with measures to strengthen safety management of bio pathogens, including botulinum bacteria.

 

On the 3rd, the KDCA announced the results of an all-in-one survey of 24 botulinum-bearing institutions, including Botox producers' acquisition of botulinum strains and illegal transactions.

 

The KDCA conducted a written survey of 24 institutions from December 2 to 11 last year and conducted an on-site survey of 11 institutions from February 3 to March 4 this year.

 

As a result of the investigation, insufficient management was confirmed, including analysis of the source and characteristics of strains, security management of bacteria handlers, illegal acquisition of strains, and suspected cases of false separation reports.

 

Inspection items included permission to possess germs, separation and movement of germs, violations of the Biochemical Weapons Act, detailed copies of experimental notes, interviews with fungal separators, and results of the agency's security system.

 

Botulinum toxins are highly likely to use bioterrorism, which requires strict management, but it has been revealed that there is a lack of human security management system to prevent illegal transactions and exploitation.

 

Suspicions of strains exploitation have been raised through the transfer of some handlers, but problems have also been identified without legal grounds to identify the list of handlers and the status of transfers.

 

There was no regulation on the reasons for disqualification, such as the definition and scope of handlers and criminal experience, so there was even a blind spot for management.

 

In addition, there was no mandatory regulation for record preparation and management, including research notes that record the entire process of research and development, and genetic information on pathogens such as the entire sequence was excluded from the management list.

 

Of the seven institutions that conducted on-site surveys to check whether bacteria were separated, five institutions were not prepared experimental notes by date and experimental process, and two institutions were confirmed to lack experimental notes.

 

It has been confirmed that strains of some institutions reported to be separated in Korea are very similar to those of the United States.

 

Specifically, the problematic strains had a genetic sequence consistency of 99.99% or more with the U.S.

 

strains.

 

While trying to determine the source of botulinum, there were also suspected violations of genetically modified organism and methods for prevention of infectious diseases related to safety management of pathogens.

 

A total of four violations of the law, including two suspected violations of mobile reporting, one violation of genetically modified organism development and approval of experiments, and one suspected false separation report.

 

In consultation with related ministries and the National Assembly, the KDCA plans to revise related laws, including the mandatory submission of strains to test records of bio-terrorism infectious disease pathogens, handler management, and bio-terrorism pathogen data (DB).

 

It will also push for mandatory recording and management, such as preparing research notes and diaries for experiments and production processes related to bacterial handling.

 

The government plans to investigate and analyze overseas cases so that it can check the criminal history and mental history of handlers and introduce the disqualification of handlers in accordance with domestic conditions.

 

The goal is to prevent false reports and illegal transactions by making it mandatory to submit strains if they have bioterrorism pathogens such as botulinum bacteria.

 

It will also quickly respond to bioterrorism by establishing an analysis of the entire sequence of bioterrorism pathogens, genetic diversity analysis, and molecular epidemiological in the event of bioterrorism.

 

In addition, the government will prepare methods and procedures necessary for establishing and implementing security measures for fungal handling agencies to prevent exploitation, outflow, and deviant behavior of strains.

 

"Botulinum, which produce neurotoxins that are fatal to humans, can pose a serious risk to people's health in the event of bioterrorism and accidents," Jeong Eun Kyeong, commissioner of the Korea Disease Control and Prevention Agency (KDCA) said.

 

"We will compensate for the deficiencies in the bioterrorism pathogen management system confirmed by the investigation and strengthen safety management," she said.