Bacillus strains added to Domestic Substances List

Summary#

This is Order 2021-112-16-01 Amending the Domestic Substances List (published in the Canada Gazette, Part II on January 5, 2022, registered December 17, 2021). It adds two bacterial strains to the national inventory while keeping special reporting rules for some new uses, and it removes a previous reporting requirement for one engineered yeast strain.

What it does#

• Adds these two living organisms to the Domestic Substances List:
  • Bacillus subtilis strain HF2
  • Bacillus subtilis strain 43B6r
• Applies the Significant New Activity (SNAc) rules under the Canadian Environmental Protection Act, 1999 (CEPA) to both of those Bacillus strains. That means people must notify the federal government before starting certain new uses.
• Removes the SNAc requirement for the engineered yeast Saccharomyces cerevisiae expressing pyruvate formate lyase activating enzyme, pyruvate formate lyase and bifunctional acetaldehyde‑CoA/alcohol dehydrogenase from Bifidobacterium adolescentis and a glucoamylase from Saccharomycopsis fibuligera, because updated assessments found the risks are negligible to low.
• Specifies what counts as a “significant new activity” for the two Bacillus strains. Notification is required for any use except these existing, lower-risk uses:
  • maintaining grease traps or drains connected to municipal wastewater systems;
  • cleaning floors in commercial establishments;
  • controlling odours in dumpsters and trash compactors;
  • treating water in artificial aquatic environments such as aquariums and ornamental ponds.
• Lists exceptions where notification is not required, including:
  • agricultural research studies that meet certain criteria;
  • contained research and development uses if the organism will not leave the facility and is imported in quantities under 50 mL or 50 g, or is present in the facility in quantities under 1,000 L;
  • production of a substance in a contained facility where the organism is not released outside;
  • sale and distribution for the exempted uses above.
• Sets the information and testing that must be sent to the Minister at least 120 days before starting any proposed significant new activity.

Who's affected#

• Businesses or researchers who want to manufacture, import, sell, or use Bacillus subtilis strain HF2 or Bacillus subtilis strain 43B6r for new activities not listed as exempt. They must submit detailed information to the federal government before starting those activities.
• Companies that currently use the engineered Saccharomyces cerevisiae strain may notice one less reporting requirement, because its SNAc obligations were removed.
• Labs and test facilities that would run the environmental toxicity studies required for a Significant New Activity Notification.
• The general public and communities near natural water or soil environments, indirectly, because the changes are meant to manage environmental risks. If it is unclear whether a specific use is covered, the order points people to contact the Department of the Environment for clarification.

Why it matters#

• The change is mainly about safety checks. The government added reporting rules for the two Bacillus strains because they might harm aquatic or terrestrial invertebrates if released into the environment in new ways.
• Requiring advance notice gives regulators time to review data and, if needed, put risk limits in place before a new use begins.
• Removing the SNAc rule for the engineered yeast reduces a regulatory step for users of that strain, reflecting updated evidence that it poses low risk.
• Adding a substance to the Domestic Substances List is administrative and does not mean the government endorses its use. It also does not override other laws or permits that might apply.