Aspergillus oryzae - information sheet

Strain ATCC 11866

Overview

The Government of Canada conducted a science-based evaluation of Aspergillus oryzae strain ATCC 11866, called a screening assessment, to address the potential for harm to Canadians and the environment.
Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by a substance 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 the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
- More information on assessing risk can be found in the Framework for Science-Based Risk Assessment of Micro-Organisms Regulated under the Canadian Environmental Protection Act, 1999.
Aspergillus oryzae strain ATCC 11866 is not hazardous to the health of the general Canadian population or the environment, but some concerns were identified for susceptible individuals. Exposure of Canadians and the environment is low. Therefore, it is concluded that Aspergillus oryzae strain ATCC 11866 is not harmful to human health or to the environment.

This screening assessment focuses on the organism Aspergillus oryzae strain ATCC 11866. This Priority A (higher hazard) organism was assessed as part of the micro-organisms initiative of the Chemicals Management Plan (CMP).
Aspergillus oryzae strain ATCC 11866 is a fungus that could have a number of consumer, commercial and industrial uses. The characteristics of Aspergillus oryzae strain ATCC 11866 make it suitable for use in various applications, including fermentation, enzyme production, bioremediation, and waste and waste water treatment.
Aspergillus oryzae strain ATCC 11866 was not reported to be manufactured in or imported into Canada.

According to information available to the Government of Canada, Canadians are not expected to be exposed to Aspergillus oryzae strain ATCC 11866, nor is it expected to be released into the Canadian environment.

Although there have been no reports of human, animal or plant disease that are specifically attributed to Aspergillus oryzae strain ATCC 11866, other strains of Aspergillus oryzae have been reported to infect immunocompromised individuals.
Aspergillus oryzae strain ATCC 11866 also shares potentially harmful characteristics with the species Aspergillus flavus, which is a known plant pathogen and opportunistic animal pathogen, and is reported to cause sinus and eye infections in healthy humans and fatal lung disease and systemic infection in susceptible individuals (for example, immunocompromised, elderly and newborns).
Aspergillus oryzae strain ATCC 11866 is susceptible to major clinical antifungal drugs.

Considering all information presented in this assessment, the risk to human health from Aspergillus oryzae strain ATCC 11866 is low.
Also considering all information presented, there is low risk of harm to organisms and the broader integrity of the environment from Aspergillus oryzae strain ATCC 11866.
The Government of Canada published the Final Screening Assessment for Aspergillus oryzae strain ATCC 11866 on January 21, 2017.

As a result of this screening assessment, the Government concluded that Aspergillus oryzae strain ATCC 11866 is not harmful to human health at current levels of exposure.
The Government also concluded that Aspergillus oryzae strain ATCC 11866 is not entering the environment at levels that are harmful to the environment.

Although Aspergillus oryzae strain ATCC 11866 is not considered to be harmful to human health or to the environment at current levels of exposure, it could become harmful to human health if exposure levels were to increase. Consequently, the Government has applied the Significant New Activity (SNAc) provisions of CEPA 1999 to Aspergillus oryzae strain ATCC 11866.
The SNAc provisions require a person (individual or corporation) proposing to use this organism in a health care setting or in a consumer product to submit prescribed information to the Government for assessment of potential risks to human health in relation to the proposed new activity. If risks are identified, the Government can take action to manage them.
Further information and updates on risk management actions can be found in the CMP risk management actions table.