Recombinant viruses added to Domestic Substances List

Summary#

Order 2023-112-04-01 Amending the Domestic Substances List adds five specific genetically modified viruses to Part 5 of the Domestic Substances List. The Order was registered on March 14, 2023 and published in the Canada Gazette on March 29, 2023; it came into force when registered.

What it does#

• Adds the following living organisms to Part 5 of the Domestic Substances List under the heading “Organisms/Organismes”:
  • Recombinant adeno-associated virus (AAV) containing AAV-LK03 capsid (AAV-Spark200) and encoding the SQ variant of B-domain deleted human factor VIII
  • Recombinant live-attenuated dengue virus serotype 1 modified from strain Western Pacific (rDENV1Δ30‑V181)
  • Recombinant live-attenuated dengue virus serotype 2 modified from strain New Guinea C (rDENV2/4Δ30 (ME)‑V181)
  • Recombinant live-attenuated dengue virus serotype 3 modified from strain Slemen/78 (rDENV3Δ30/31‑V181)
  • Recombinant live-attenuated dengue virus serotype 4 modified from strain Dominica/81/814669 (rDENV4Δ30‑V181)
• The Order notes that the federal ministers who reviewed the notifications were satisfied with the information provided and that any assessment periods have expired. No special conditions under the assessment provision are in effect for these organisms.

Who's affected#

• Companies, research labs, or institutions that manufacture, import, or work with any of the five listed organisms in Canada.
• Federal health and environment authorities involved in approving and tracking biological products, including Health Canada and the Minister of the Environment (who signed the Order).
• It is unclear from the Order whether there are any immediate changes for patients, clinical trials, or commercial products; affected parties should check with regulators for specific obligations.

Why it matters#

• Being added to the Domestic Substances List means these specific genetically modified viruses are now listed in the federal inventory of substances. That can affect how they are treated under the Canadian Environmental Protection Act, 1999, and may change what notifications or approvals are needed before they are made, imported, or used in Canada.
• If you make, import, or use these organisms, you should review any remaining regulatory requirements with Health Canada or the department responsible for environmental assessment to understand practical next steps.