Bacillus strains added to Domestic Substances List

Summary#

This is Order 2021-112-11-01 Amending the Domestic Substances List: SOR/2021-250. It adds two bacterial strains to the Domestic Substances List and keeps special reporting rules that require advance notice for certain new uses. The order was registered on December 17, 2021 and published in the Canada Gazette on January 5, 2022.

What it does#

• Adds these two living organisms to Part 6 of the Domestic Substances List:
  • Bacillus amyloliquefaciens subspecies amyloliquefaciens strain W215
  • Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48
• Keeps Significant New Activity (SNAc) reporting requirements for those strains. That means anyone planning a “significant new activity” with them must notify the federal government ahead of time.
• The notification (a SNAN) must be submitted at least 120 days before the proposed activity.
• Uses that trigger the notification requirement are any uses other than these existing uses:
  • maintaining grease traps in commercial establishments 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 (for example, aquariums and ornamental ponds).
• The following are explicitly not considered “significant new activities” (so they do not need a SNAN):
  • agricultural research studies that meet the stated regulatory conditions;
  • research and development in a contained facility if the organism is not released outside and is imported in less than 50 mL or 50 g, or is made in the facility and present at any time in less than 1,000 L;
  • use for producing a substance inside a contained facility where the organism is not released outside;
  • sale and distribution for the exempted uses listed above.
• The SNAN must include specific data, including tests on effects to aquatic and terrestrial invertebrates done according to the government’s test guidance (the order cites methods in Report EPS 1/RM/44, December 2016). Those studies must follow recognised Good Laboratory Practice.
• The government will assess a complete SNAN within 120 days of receiving it.
• Because the strains are now on the Domestic Substances List, they are no longer treated as “new” under the New Substances Notification Regulations (Organisms) for the uses already in place.

Who's affected#

• Companies that manufacture, import, sell or plan new uses for either Bacillus amyloliquefaciens subspecies amyloliquefaciens strain W215 or Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48. They must notify the government before starting certain new activities.
• Businesses that use these strains in the listed, exempted ways (grease traps, floor cleaning in commercial places, dumpster odour control, aquariums/ornamental ponds) are not required to submit a SNAN for those uses.
• Researchers doing qualifying agricultural studies or contained R&D under the volume limits are generally exempt from the notification requirement.
• Environment Canada and Health Canada will continue to review any SNANs and may require risk-management steps if needed.

Why it matters#

• The rule keeps a safety step in place for potential new uses that could release these bacteria into natural environments. The government identified possible harms to aquatic and terrestrial invertebrates from some uses, so it wants advance information before those uses proceed.
• For businesses: current permitted commercial uses are easier to continue (less new-substance paperwork), but any new or different commercial uses may require costly testing and a waiting period of at least 120 days for federal assessment.
• For researchers and small-scale labs: the order clarifies exemptions and volume limits so routine contained research can continue without extra federal notification in many cases.