Organisms added to Domestic Substances List

Summary#

Order 2024-112-05-01 Amending the Domestic Substances List adds several living organisms to Canada’s Domestic Substances List and removes special reporting rules for three specific Pseudomonas strains. The change took effect on June 28, 2024.

What it does#

• Adds these living organisms to Part 5 of the Domestic Substances List:

  • Escherichia coli strain SYNB1934v1
  • Human autologous T lymphocytes transduced with a replication-incompetent recombinant lentiviral vector carrying a CLDN18.2-directed receptor gene (CT041)
  • Pseudomonas aeruginosa ATCC 31480
  • Pseudomonas aeruginosa ATCC 700370
  • Pseudomonas aeruginosa ATCC 700371

• Removes the Significant New Activity (SNAc) listings for the three Pseudomonas strains (the entries in Part 6 that previously required extra notification). The three Pseudomonas strains are moved or listed without SNAc requirements in Part 5.

• Practical effect: these organisms are no longer treated as “new” under the New Substances Notification Regulations (Organisms), and the SNAc reporting requirements for the three Pseudomonas strains are rescinded.

• The order was registered (and came into force) on June 28, 2024.

Who's affected#

• Biotechnology and pharmaceutical companies that make, import, or use these specific organisms or cell therapies.
• Research laboratories and academic institutions working with the listed strains or the CT041 cell product.
• Clinical trial sponsors and manufacturers involved with CT041 (a cell therapy product).
• Importers and distributors of the listed strains.
• Federal regulators and public health authorities who oversee pathogen controls.

It is unclear from the order whether everyday consumers will notice any direct effects.

Why it matters#

• Being added to the Domestic Substances List means the named organisms are no longer subject to pre-market notification under the New Substances Notification Regulations (Organisms). That can make it administratively easier for businesses and researchers to bring these organisms into use in Canada.
• Rescinding the SNAc requirements for the three Pseudomonas aeruginosa strains removes a specific reporting step for “significant new activities,” because those risks are already managed under the Human Pathogens and Toxins Act and its regulations. This reduces duplicate oversight rather than reducing safety controls.
• The order is largely administrative: it does not introduce new safety rules or approval for use. It clarifies which federal rules apply to these organisms.