Six Living Organisms Added to Domestic Substances List

Summary#

Order 2024-112-04-01 Amending the Domestic Substances List adds 6 living organisms to Canada’s inventory of existing substances. The order took effect on May 9, 2024, the day it was registered. Being added means these organisms are no longer treated as “new” under the notification rules for organisms.

What it does#

• Adds the following three named organisms to Part 5 of the Domestic Substances List:
  • Anaerobic 1,1,1-trichloroethane degrading consortium KB-1 plus 1,1,1-TCA
  • Autologous CD34+ hematopoietic stem and progenitor cells edited by CRISPR/CAS12a system at the HBG1 and HBG2 Promoters (EDIT-301)
  • Recombinant, chimeric vesicular stomatitis virus (VSV) carrying the envelope glycoprotein (GP) of the visceral non‑neurotropic WE‑HPI strain of the lymphocytic choriomeningitis virus, and a codon‑optimized human CD80 gene fused to the Fc IgG1 heavy chain constant region
• Adds the following three entries (identified by their confidential accession numbers) to Part 7 of the Domestic Substances List:
  • 19678-6 — A genetically modified Drosophila melanogaster strain with a single insert expressing bovine FGF2
  • 19702-0 — Human T lymphocytes transduced with a replication‑incompetent lentiviral vector encoding a CAR targeting a human B cell antigen (CLIC-1901)
  • 19705-3 — A genetically modified Drosophila melanogaster strain with a single insert expressing human FGF2
• Once on the list, these organisms are no longer subject to the New Substances Notification Regulations (Organisms).

Who's affected#

• Companies or researchers who manufactured or imported these specific organisms into Canada.
• Biotechnology labs, clinical developers, and suppliers that work with genetically modified organisms, cell therapies, or viral vectors.
• The public and regulators indirectly, because these additions change how these organisms are tracked and reviewed under federal rules.

It’s not clear from the order which specific companies or institutions were involved. The change applies to the named organisms themselves, not to a broader category.

Why it matters#

• Being added to the Domestic Substances List means these organisms are treated as existing in Canada. That removes the requirement for the original notifier to submit further “new substance” notifications for them.
• This can make it simpler for businesses and researchers to use or supply these organisms in Canada, because they no longer face the extra step of new‑substance filings under the organisms notification rules.
• The order is administrative. It does not mean the government endorses the safety of these organisms, nor does it change other laws or safety rules that might apply.