Four Engineered Organisms Added to DSL

Summary#

The federal government published Order 2024-112-03-01 Amending the Domestic Substances List, which adds four engineered organisms to the Domestic Substances List. The order was registered and came into force on April 11, 2024 and was published in the Canada Gazette on April 24, 2024.

What it does#

• Adds three organisms to Part 5 (the “Organisms” section) of the Domestic Substances List:
  • Recombinant and non-replicative single-stranded adeno-associated viral vector of serotype 2 expressing a soluble human CD59 gene (AAVCAGsCD59) — shown with an “N” beside it in the list.
  • Recombinant human T‑cells transduced with a non-replicative lentiviral vector expressing a chimeric antigen receptor binding the human B‑cell maturation antigen (PHE885) — shown with an “N”.
  • Saccharomyces cerevisiae expressing lactate dehydrogenase (LDH) from rhizopus oryzae — shown with an “N”.
• Adds one entry to Part 7 of the List (a numeric entry):
  • 19703-1 N Recombinant human T lymphocytes expressing a CD19‑specific chimeric antigen receptor (TBI‑2001).
• The Order was signed by Steven Guilbeault on April 9, 2024. The Order states it comes into force on the day it is registered (which was April 11, 2024).
• The listing shows an “N” next to each addition in the published text; the Order itself does not explain that letter within its text.

Who's affected#

• Developers, manufacturers and importers of the specific viral vectors and engineered cells listed (for example those working on PHE885 and TBI‑2001).
• Biotech and pharmaceutical companies and research labs that work with the listed organisms.
• Health and environmental regulators responsible for tracking and overseeing new biological substances (the Order references the Canadian Environmental Protection Act, 1999 and involvement of the Minister of the Environment and the Minister of Health).
• It is not fully clear from the Order text alone how day‑to‑day regulatory obligations change for each party; the document records the additions but does not spell out other regulatory consequences.

Why it matters#

• Being added to the Domestic Substances List records that these specific engineered viruses, yeast strains, and CAR‑T cell products have been reported and assessed under the Canadian Environmental Protection Act, 1999, and that the assessment period expired without conditions noted in the Order.
• For companies and researchers, the listing is a formal step that relates to how these materials are tracked federally in Canada. That can affect reporting, oversight and planning for manufacturing or clinical work.
• For the public, the additions indicate that certain advanced biological therapies and engineered organisms are being manufactured or imported into Canada and are now recorded on the federal list. The Order itself does not explain in detail what that means for safety, approvals, or clinical use.