The Government of Canada conducted a science-based evaluation, called a screening assessment, of Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) to address the potential for harm to Canadians and the environment.
Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by an organism is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people or to the environment. An organism may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) are human and animal pathogens. At current levels of exposure, it is proposed to conclude that Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) are not harmful to human health or to the environment.
About these organisms
This screening assessment focuses on 2 organisms, Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus).
Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) are bacteria that could have a number of consumer, commercial and industrial uses.
Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) have characteristics in common with other strains of the species Bacillus cereus, which are found in nature.
The characteristics of Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) make them suitable for use in various applications, including as active ingredients in detergents, degreasers, additives for biodegradation and bioremediation, and in various industrial processes.
Based on a 2009 survey, Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) were not reported to be manufactured in or imported into Canada except for limited quantities used for academic research, teaching, and research and development activities.
Exposure of Canadians and the environment
According to information available to the Government of Canada, Canadians are not expected to be exposed to Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus), nor are these organisms expected to be released into the Canadian environment.
Bacillus cereus is considered to be Risk Group 2 (moderate individual risk, low community risk) human pathogens by the Public Health Agency of Canada and measures to reduce human and environmental exposure to Risk Group 2 pathogens from their use in research and teaching laboratories are in place under the Canadian Biosafety Standard Second Edition, 2015 (CBS 2015).
Key health and ecological effects (hazard)
Bacillus cereus is primarily a gastrointestinal pathogen. Gastrointestinal infections in healthy humans are generally mild, self-resolving and usually treatable, however, a few fatalities have been reported in children.
Both Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) have the potential to produce hemolysin BL, nonhemolytic enterotoxin, hemolysins, and phospholipase C, which are important factors in causing gastrointestinal disease in both susceptible and healthy individuals.
Non-gastrointestinal Bacillus cereus diseases are less frequent, and are generally associated with invasive medical procedures. In susceptible individuals, these infections have a higher mortality rate. Wound infections have also been documented for Bacillus cereus in otherwise-healthy individuals; however, these are rare.
Antibiotics effective against Bacillus cereus infections are available; however, the treatment of Bacillus cereus strain ATCC 14579 or Bacillus subtilis strain 11685-3 (Bacillus cereus) infections could be hampered by existing resistance to several antimicrobial drugs.
Bacillus cereus can infect some animals and cause a range of effects that can debilitate and even kill them. Under normal circumstances it is unlikely to be a serious hazard to healthy livestock or other organisms in the environment. It has been reported to cause mastitis in cows, but affected animals recover rapidly upon treatment with veterinary antibiotics.
Risk assessment outcomes
Considering all information presented, the risk to human health from Bacillus cereus strain ATCC 14579 or Bacillus subtilis strain 11685-3 (Bacillus cereus) is low.
Also considering all information presented, there is low risk of harm to organisms and the broader integrity of the environment from Bacillus cereus strain ATCC 14579 or Bacillus subtilis strain 11685-3 (Bacillus cereus)
As a result of this assessment, the Government concluded that Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) are not harmful to human health at current levels of exposure.
The Government also concluded that Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) are not entering the environment at levels that may be harmful to the environment.
Preventive actions and reducing risk
In 2017, Bacillus subtilis strain 11685-3 (Bacillus cereus) was added to the screening assessment after testing by government scientists showed that it was a strain of Bacillus cereus. Information reviewed to support the assessment of Bacillus cereus strain ATCC 14579 applies equally to Bacillus subtilis strain 11685-3 (Bacillus cereus).
Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) are considered to be Risk Group 2 human pathogens by the Public Health Agency of Canada. A license under the Human Pathogens and Toxins Regulations is required for controlled activities with Risk Group 2 human pathogens. Adhering to provisions of the Canadian Biosafety Standard Second Edition, 2015 (CBS 2015), as a condition of the license, is expected to minimize human and environmental exposure to Risk Group 2 pathogens, including Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus).
The Government is proposing to take no further action under CEPA 1999 on Bacillus cereus strain ATCC 14579 and Bacillus subtilis strain 11685-3 (Bacillus cereus) while they remain subject to requirements for Risk Group 2 pathogens under the Human Pathogens and Toxins Act.
