SNAc Rules for Trichoderma reesei ATCC 74252

Summary#

Order 2021-112-20-01 Amending the Domestic Substances List moves a specific strain of the fungus Trichoderma reesei ATCC 74252 onto the part of the list that triggers Significant New Activity (SNAc) rules under the Canadian Environmental Protection Act, 1999. That means anyone planning to import, make, or use this strain in a way that is new or different must notify the government in advance and provide specific data.

What it does#

• It removes Trichoderma reesei ATCC 74252 from the part of the Domestic Substances List for routine listed organisms and adds it to the SNAc part.
• Anyone proposing a significant new activity with this strain must send a notification at least 120 days before the activity starts.
• The notification must include basic details about the proposed activity and specific test data, including:
  • a study showing whether the fungus produces peptaibols (a type of secondary chemical) and how much is present in liquid culture medium;
  • if aquatic or terrestrial invertebrates could be exposed, studies on effects of the fungus and of the peptaibols on those species.
• Required studies must follow recognized lab standards (OECD Good Laboratory Practice and Environment and Climate Change Canada guidance for testing microbes).
• Some uses are exempt from notification, including:
  • submerged fermentation without light and without solid plant material or insoluble substrate;
  • culture that is inactivated to an inactivation rate of 99.9999% before removal and whose wastes are incinerated;
  • research-and-development uses that meet specific containment conditions;
  • transit through Canada and uses already regulated under other federal acts (for example, pest control or seeds laws).
• The government will assess a complete notification within 120 days of receiving it.
• The Order came into force on the day it was registered (registered August 6, 2021; published in the Canada Gazette on August 18, 2021).

Who's affected#

• Companies that import, manufacture, or plan new commercial uses of Trichoderma reesei ATCC 74252, especially if those uses could release the organism into the environment (for example, bioremediation, biodegradation, pesticides or field testing).
• Research labs and biotech firms proposing activities outside the exempted contained processes.
• The federal reviewers at Environment and Climate Change Canada and Health Canada, who will assess notifications and any needed risk-management.
• Current users operating within contained fermentation processes are generally not affected by this Order.

Why it matters#

• The strain is not currently judged to be toxic at reported exposure levels, but it produces chemicals (peptaibols) that can harm some invertebrates. The Order gives the government a chance to review and, if needed, manage risks before new or expanded uses happen.
• This protects plants, aquatic and terrestrial invertebrates, and ecosystems from unintended effects if the fungus were used in ways that increase environmental exposure.
• For businesses or researchers planning new uses, the Order adds time and testing requirements (and possible costs) before they can proceed.
• It does not change or add rules for existing contained industrial uses reported in Canada.