Aspergillus niger Group - information sheet

Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342)
Aspergillus brasiliensis strain ATCC 9642

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Overview

  • The Government of Canada conducted a science-based evaluation, called a screening assessment to address the potential for harm to Canadians and the environment from Aspergillus awamori strain ATCC 22342 (=Aspergillus niger ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642.
  • 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 to 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.
  • In the case of Aspergillus awamori strain ATCC 22342 (=Aspergillus niger ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642, the organisms are estimated to have a medium hazard toward human health and medium and low-medium hazard toward the environment respectively. The exposure to Canadians and the environment is estimated to be low. Therefore, it is concluded that Aspergillus awamori strain ATCC 22342 (=Aspergillus niger ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 are not harmful to human health or to the environment.

About these organisms

  • This screening assessment focuses on 2 organisms, Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642. These organisms were assessed as part of the second phase of the Chemicals Management Plan (CMP).
  • Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 are fungi that could have a number of consumer, commercial and industrial uses.
  • The characteristics of Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 make them suitable for use in various applications including bioremediation, biodegradation, bioleaching, textile processing, waste treatment, and enzyme and fermentation extract production.
  • Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642, both are found in nature, have characteristics in common with Aspergillus niger and are often not distinguished in the literature.
  • Based on a 2017 survey, Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 were not reported to be manufactured in or imported into Canada.

Human and ecological exposures

  • According to information gathered by the Government, Canadians are not expected to be exposed to Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) or to Aspergillus brasiliensis strain ATCC 9642.

Key health and ecological effects (hazard)

  • Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 are thought to share hazardous properties with Aspergillus niger.
  • Aspergillus can cause a wide array of infections, including lung, skin, eye, heart and systemic infections. It produces a wide variety of extracellular enzymes and toxins that are important factors for its pathogenicity in humans.
  • The risk of Aspergillus niger infection increases with pre-disposing factors such as debilitating disease, surgery, the presence of indwelling medical devices and immune deficiency. Aspergillus niger also has pathogenic potential in otherwise healthy humans, and recent research suggests the same potential in Aspergillus brasiliensis.
  • The vast majority of Aspergillus niger-related diseases in healthy humans are mild, self-resolving and usually treatable, but there have been mortalities in immunocompromised individuals, and ear and eye infections in healthy individuals which could result in irreversible damage to the ears or eyes, such as hearing or vision loss.
  • Aspergillus brasiliensis and Aspergillus niger are both resistant to fluconazole, an antifungal drug, which could limit treatment options.
  • Certain Aspergillus niger strains produce moderately to highly toxic mycotoxins and secondary metabolites. Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) is known to produce mycotoxins such as fumonisin and ochratoxin. Both fumonisin and ochratoxin are reported to cause adverse effects in animals. Although there have been no reports of animal or plant disease that are specifically attributed to Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342), some Aspergillus niger strains have been reported as plant pathogens and opportunistic animal pathogens causing mycoses, mastitis and aspergillosis (lung infection/disease).
  • Considering the potential for the production of fumonisin and ochratoxin by certain Aspergillus niger strains and difficulties in distinguishing Aspergillus brasiliensis from other black aspergilli that cause disease in animals or plants, the environmental hazard potential of Aspergillus brasiliensis ATCC 9642 is assessed to be low to medium.

Risk assessment outcomes

Screening assessment conclusions

  • As a result of this screening assessment, the Government concluded that Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 are not harmful to human health at current levels of exposure.
  • The Government also concluded that Aspergillus awamori strain ATCC 22342 (=Aspergillusniger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 are not entering the environment at levels that are harmful to the environment.

Preventative actions and reducing risk

  • Although Aspergillus awamori ATCC 22342 (=Aspergillus niger ATCC 22342) and Aspergillus brasiliensis ATCC 9642 are not considered to be harmful to human health or the environment at current levels of exposure, these organisms have potential health effects of concern. There may be concern for human health if exposures were to increase.
  • Therefore, the Government of Canada published a notice of intent to apply the Significant New Activity (SNAc) provisions of CEPA 1999 to these organisms. The SNAc provisions would require that the Government be notified of any proposed new activities related to these organisms, and that the new activity be assessed before being undertaken. This publication has a 60-day public comment period ending on October 23, 2019.
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