SNAc Rules for Two Aspergillus Strains

Summary#

Order 2021-112-21-01 Amending the Domestic Substances List applies the Significant New Activity (SNAc) rules under the Canadian Environmental Protection Act, 1999 to two specific strains of Aspergillus fungi. People proposing certain new uses of these strains must notify the government and provide data at least 120 days before starting the activity. The order was registered on June 13, 2022 and published in the Canada Gazette on June 22, 2022.

What it does#

• Adds Aspergillus awamori ATCC 22342 and Aspergillus brasiliensis ATCC 9642 to Part 6 of the Domestic Substances List so the SNAc rules apply to them.
• Requires a Significant New Activity Notification (SNAN) to be sent to the Minister at least 120 days before importing, manufacturing, or using these organisms for a covered new activity.
• Specifies the kind of information the notifier must give, including details about the proposed use, test data, exposure and hazard information, and contact details for the notifier and testing labs.
• Lists activities that do trigger notification:
  • Use in consumer products covered by the Canada Consumer Product Safety Act.
  • Use in health care settings (for example, hospitals, clinics, long-term care homes).
• Lists activities that do not trigger notification:
  • Transit through Canada without introduction to the environment.
  • Research and development in contained facilities that meet specific containment rules.
  • Uses already regulated under other federal acts (for example, the Pest Control Products Act, Seeds Act, Fertilizers Act, Feeds Act, Health of Animals Act).
• The government will assess any complete SNAN within the timelines set by the order and may require risk management before the activity proceeds.

Who's affected#

• Businesses that might import, manufacture, or start new uses of Aspergillus awamori ATCC 22342 or Aspergillus brasiliensis ATCC 9642, including makers of consumer products and industrial users.
• Suppliers and distributors who would need to pass information along to buyers.
• Operators of health care facilities where a proposed use would introduce these organisms.
• Laboratories and researchers who would generate test data for a SNAN (research in contained facilities is generally exempt).
• It is unclear how many companies will be affected now because mandatory surveys found very limited use of these strains in 2008 and 2016.

Why it matters#

• These two fungal strains have properties of concern. They can be opportunistic pathogens and may produce toxic compounds (for example, fumonisin and ochratoxin). They also share traits with strains that can resist common antifungal treatment (resistance to fluconazole was noted).
• The SNAc requirement gives the government time to evaluate the safety of a proposed new use before people or products increase public or environmental exposure. That reduces the risk of unintended harm in hospitals, homes, farms, or the environment.
• For businesses, the requirement means planning: submit a SNAN 120 days in advance and possibly pay to generate required data. The order does not impose new obligations on existing, limited uses.