Allegations of Strain Theft Arise Through Handler Turnover, but No Legal Basis Exists
[Asia Economy Reporter Seo So-jeong] The government has decided to strengthen safety management due to inadequate control over Clostridium botulinum, which requires strict management because of its high potential for use in bioterrorism.
The Korea Disease Control and Prevention Agency (Director Jeong Eun-kyung), together with the Ministry of Trade, Industry and Energy and the National Intelligence Service, conducted a comprehensive inspection of 24 institutions possessing Clostridium botulinum strains. On the 3rd, they announced that they identified management deficiencies such as unclear strain origin and characteristic analysis, inadequate security management of handlers, illegal acquisition of strains, and suspected false isolation reports.
The inspection items included compliance with permits for strain possession, isolation and transfer reporting under the Infectious Disease Control and Prevention Act, violations of the Biological and Chemical Weapons Control Act, detailed laboratory notebook records, interviews with strain isolators, strain characteristic analysis and results, and the operation status of institutional security systems.
In particular, the investigation confirmed that the personnel security management system to prevent illegal trade and theft of Clostridium botulinum strains was insufficient.
Although suspicions of strain theft through the turnover of some handlers were raised, the lack of legal grounds to track handler lists and turnover status was pointed out as a problem. Additionally, there were no regulations defining handlers, their scope, or disqualifications such as criminal records, creating blind spots in management.
There were no regulations mandating the creation and management of records such as research notebooks documenting the entire research and development process, and pathogen genetic information such as whole genome sequences was excluded from management targets, limiting verification of strain isolation facts.
Among the seven institutions where on-site investigations were conducted to verify strain isolation, five were found not to have prepared laboratory notebooks by date or experimental process. Two institutions did not have laboratory notebooks at all.
Some strains reported as isolated domestically were found to have very high similarity (over 99.99%) to strains isolated in the United States.
Furthermore, while investigating the origin of Clostridium botulinum strains, suspected violations related to pathogen safety management under the Infectious Disease Control and Prevention Act and the Genetically Modified Organisms Act were also identified. Four legal violation cases were confirmed: two suspected transfer reporting violations, one violation of approval for development and experimentation of genetically modified organisms, and one suspected false isolation report.
The Korea Disease Control and Prevention Agency plans to revise related laws in consultation with relevant ministries and the National Assembly to mandate strain submission for building a database (DB) on bioterrorism infectious disease pathogens’ experimental records and handler management. They will also promote mandatory record-keeping such as research notebooks and logs for experimental and production processes related to strain handling.
To verify handlers’ criminal records and mental health history, overseas cases will be investigated and analyzed to introduce disqualification criteria suitable for domestic conditions.
Through this, when possessing bioterrorism infectious disease pathogens such as Clostridium botulinum, mandatory strain submission will prevent false reporting and illegal transactions. They will also build data including whole genome sequence analysis, genomic diversity analysis, and molecular epidemiological information to enable rapid response in case of bioterrorism incidents.
Measures and procedures necessary for establishing and implementing security plans at institutions handling strains will also be prepared to prevent strain theft, leakage, and handler misconduct.
Jeong Eun-kyung, Director of the Korea Disease Control and Prevention Agency, said, "Clostridium botulinum, which produces a neurotoxin fatal to humans, poses a serious risk to public health if leaked due to bioterrorism or accidents, so thorough management is necessary. We plan to supplement the deficiencies in the bioterrorism infectious disease pathogen management system identified through this investigation and strengthen safety management."
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