Four Living Organisms Added to Domestic List

Summary#

Order 2021-112-01-01 Amending the Domestic Substances List adds 4 living organisms to the Domestic Substances List. The order was registered and came into force on January 26, 2021, and was published in the Canada Gazette, Part II. As a result, those organisms are no longer treated as “new” under Canada’s new-substance notification rules.

What it does#

• Adds these four living organisms to Part 5 of the Domestic Substances List:
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Hong Kong/2671/2019 (H3N2) virus N
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Hawaii/66/2019 (H1N1) virus N
  • Cold-adapted, temperature-sensitive and attenuated influenza B/Washington/02/2019 (Victoria lineage) virus N
  • Human allogeneic CAR T cells targeting the B cell maturation antigen (BCMA) and genetically modified by CRISPR/Cas9 disrupting the T cell receptor alpha constant (TRAC) and β2-microglobulin (B2M) loci and by a CAR gene-containing recombinant adeno-associated virus (AAV) vector inserting the anti-BCMA CAR expression cassette into the TRAC locus N
• Because they are now on the list, these organisms are no longer subject to the notification and assessment requirements of the New Substances Notification Regulations (Organisms).
• The addition is administrative: it does not mean the government is endorsing these organisms, and it does not remove other legal or safety requirements (for example, clinical trial approvals, biosafety rules, or other Health Canada or provincial approvals).

Who's affected#

• Researchers, academic labs and vaccine developers who work with the listed influenza strains.
• Biotech and cell‑therapy companies involved with CAR‑T products and their suppliers.
• Importers, manufacturers and distributors who bring these specific organisms into Canada.
• Federal regulators such as Environment and Climate Change Canada and Health Canada, who handled the assessments that led to the addition.
• The broader public is not directly affected by the listing itself, though people may notice faster access to research materials or clinical materials that use these organisms.

Why it matters#

• Removing these organisms from “new‑substance” rules lowers the paperwork barrier for people who manufacture, import or use them in Canada. That can speed research, clinical trials and manufacturing activities that rely on these specific strains or the listed CAR‑T cells.
• The change is administrative, not a safety approval. Other oversight (clinical authorizations, biosafety, provincial rules) still applies.
• The inclusion of a genetically modified human cell therapy on the list may attract public interest; the listing does not change clinical safety review processes.