Two biotech organisms added to Domestic Substances List

Summary#

Order 2020-112-07-01 Amending the Domestic Substances List adds two living organisms to Part 5 of the Domestic Substances List. The order took effect on the day it was registered (registered March 5, 2020) and removes these two organisms from the group of substances treated as “new” under the New Substances Notification Regulations (Organisms).

What it does#

• Adds these two living organisms to Part 5 of the Domestic Substances List:
  • Human autologous T lymphocytes transduced with a retroviral vector (PG13‑CD19‑H3) containing anti‑CD19/CD28/CD3zeta chimeric antigen receptor targeting CD19 on the cell surface of B cells
  • Non‑replicating, recombinant human adeno‑associated virus (AAV) serotype 8 vector containing a codon‑optimized version of the wild‑type human glucose‑6‑phosphatase‑α coding sequence under the control of its native promoter/enhancer and followed by the late poly A from SV40 and flanked by wild‑type AAV serotype 2 inverted terminal repeat (ITR) sequences
• Because these organisms are now on the Domestic Substances List, they are no longer subject to the New Substances Notification Regulations (Organisms) that apply to substances new to Canada.
• The order itself does not approve or endorse the safety or use of the organisms. Other laws and regulations (for example, health or clinical rules) may still apply.

Who's affected#

• Companies or institutions that manufactured or imported these specific organisms in Canada.
• Researchers, biotech firms and clinical developers who work with similar cell‑based or viral vector products.
• Regulators who track which organisms are treated as “new” under the notification rules.

If it is unclear whether a specific product or material you handle matches the long technical names listed here, the Canada Gazette item provides those exact descriptions for comparison.

Why it matters#

• Being listed on the Domestic Substances List changes the regulatory status. For these two organisms, that means the routine pre‑notification and assessment steps required for brand‑new organisms under the New Substances Notification Regulations (Organisms) no longer apply.
• Practically, this can make it simpler for businesses or researchers already working with these exact organisms to continue their activities in Canada — but it is not a safety approval. Other regulatory requirements (for example, clinical trial rules, sanitary or transport rules) still apply.
• The order page shows an “N” beside each organism on the list. The document does not explain that symbol at this location, so if you need clarity about reporting or restrictions, contact the substances management contacts listed in the original Canada Gazette notice.