Aspergillus niger Group - information sheet

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

Publications summarized:

• Final Screening Assessment for Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 (published on August 24, 2019)
• Associated notice: Canada Gazette, Part I: Vol. 153, No. 34 – August 24, 2019

On this page

• Overview
• About these organisms
• Human and ecological exposures
• Key health and ecological effects (hazard)
• Risk assessment outcomes
  • Screening assessment conclusions
• Preventative actions and reducing risk

Overview

• The Government of Canada conducts risk assessments of substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) to determine whether they present or may present a risk to human health or to the environment. The risks posed by a substance are determined both by its hazardous properties (potential to cause adverse human health or ecological effects) and the amount of exposure to people and the environment. When needed, the Government implements risk management measures under CEPA 1999 and other Federal Acts to help prevent or reduce potential harm.
• This page summarizes the Final Screening Assessment for Aspergillus awamori strain ATCC 22342 (=Aspergillus niger ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 and theSignificant New Activity (SNAc) provisions being applied. Public comments were sought on the draft screening assessment and SNAc Notice of Intent to be considered in the development of the final screening assessment and SNAc Order. None were received.
• The section called Preventive actions and risk reduction provides links on where to find updates on the SNAC provisions being applied.

About these organisms

• The 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, which 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. Even among healthy individuals, A. niger can cause ear and eye infections, 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, and treatment options are limited if an infection were to occur.
• Certain Aspergillus niger strains produce moderately to highly toxic mycotoxins and secondary metabolites. Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) produces mycotoxins such as fumonisin and ochratoxin, and these mycotoxins 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

• Considering all information presented, the risk to human health from Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 is low.
• Also considering all information presented, there is low risk of harm to environmental organisms and the broader integrity of the environment from Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642.
• The Government of Canada published the Final Screening Assessment for Aspergillus awamori strain ATCC 22342 (=Aspergillus niger strain ATCC 22342) and Aspergillus brasiliensis strain ATCC 9642 on August 24, 2019.

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 properties of concern that could pose a risk to human health, if exposure levels to these living organisms were to increase due to certain new activities. Consequently, the Government has applied the SNAc provisions of CEPA 1999 to Aspergillus awamori ATCC 22342 (=Aspergillus niger ATCC 22342) and Aspergillus brasiliensis ATCC 9642.
• 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.