Companies that falsely report the source of the botulinum toxin (BTX) strain will likely have to shut down their business, as the government amended the Infectious Disease Prevention Act on managing high-risk pathogens.

According to the industry sources on Friday, the amendment allows authorities to revoke the permission to possess botulinum toxin strains if a company obtained permits to possess or bring in the high-risk pathogens through deceitful or fraudulent means.

Previously, authorities could cancel the approval or close manufacturing facilities when violations are found. The toughened law, however, makes it fundamentally impossible to conduct related business, such as researching, developing, and selling high-risk pathogens, the sources said.

The amendment applies to all 36 high-risk pathogens, including Ebola and the Middle East respiratory syndrome (MERS) viruses, managed by the Korea Disease Control and Prevention Agency (KDCA). However, botulinum toxin is almost the only high-risk pathogen among them that is in the commercialization stage. This is because BTX strain is a strong poison that can kill more than a million people with just 1 gram.

The amendment states that authorities can apply the rule retroactively to the existing companies in the botulinum toxin business, which is why industry insiders expect that it will have a significant impact on the domestic industry.

More than 10 Korean companies have reported to the KCDA that they have discovered a botulinum toxin strain in Korea, with some reporting that they discovered botulinum toxin strains “accidentally” in various places such as honey, canned food, and pig farms.

In contrast, no foreign companies said they have succeeded in finding a BTX strain and commercializing it into a medical product. All of them have reported that they have officially received or bought the strains from universities or research institutues.

The KDCA conducted the investigation on the status of strains of 24 local botulinum toxin companies from December to June.

The agency found violations by four companies. Two of them had possessed the botulinum bacteria even before they reported to the government; one conducted genetic modification experiments on strains without government permission and commercialized a product; and other one may have falsified the report on how they acquired the strain to the government.

KDCA did not make public the names of the four companies and has requested the police to investigate them.

“Due to the amendment to the Infectious Disease Prevention Act, companies that falsely reported the source of the strain may have to give up on their botulinum toxin business,” an industry executive told Korea Biomedical Review on Friday, asking to remain anonymous due to the sensitivity of the issue.

The entire industry is paying close attention as to how the police conclude its investigation, she added.