Oncolytic Vaccinia Virus TBio-6517 Added

Summary#

Order 2021-112-03-01 Amending the Domestic Substances List: SOR/2021-16 adds one genetically modified virus to the Domestic Substances List. The change means that this specific organism is no longer treated as a “new substance” under the federal new-substance rules. The order came into force when it was registered on February 15, 2021 (published in the Gazette on March 3, 2021).

What it does#

• Adds this living organism to Part 5 (organisms) of the Domestic Substances List:
  • Human oncolytic Vaccinia virus Copenhagen strain with deletions in the 5 prime and 3 prime regions of the genome and B8R locus disruption, expressing anti-CTLA-4 antibody, FLT-3 ligand and membrane bound IL-12 (p35 subunit) (TBio-6517).
• Because it is now on the list, the organism is no longer subject to the New Substances Notification Regulations (Organisms) for being “new to Canada.”
• The government says the Ministers reviewed the submitted information and were satisfied the organism had been manufactured in or imported into Canada by the notifier, and that the assessment period had ended.

Who's affected#

• The company or researcher that notified the substance (the notifier).
• Other biotechnology firms, research labs, or importers working with the same organism in Canada.
• Federal regulators who track which substances are on the Domestic Substances List.
• The general public and nearby communities indirectly, because changes affect how the organism is regulated; however, the order does not itself approve release or exempt the organism from other laws.

If it is unclear who will use or commercialize this organism in Canada, the practical reach of the change is also unclear from the notice.

Why it matters#

• Being on the Domestic Substances List removes the “new substance” notification barrier for this specific organism. That can make it easier for the notifier (and possibly others) to handle, import or manufacture the organism without repeating the new-substance notification steps under CEPA.
• The order does not mean the government endorses the organism or that other safety, health or environmental rules no longer apply. Other federal, provincial or sector-specific approvals may still be needed.
• For members of the public, the main practical point is that the organism has passed the procedural step that moves it from “new” to listed — a regulatory housekeeping step that can affect how industry and researchers proceed.