Four viruses added to Domestic Substances List

Summary#

Order 2022-112-01-01 Amending the Domestic Substances List (SOR/2022-13) adds four specific living organisms to Canada’s inventory of substances. The order was registered on February 2, 2022 and took effect on that date under the Canadian Environmental Protection Act, 1999.

What it does#

• Adds these four living organisms to Part 5 of the Domestic Substances List:
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Tasmania/503/2020 (H3N2) virus
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Victoria/1/2020 (H1N1) virus
  • Recombinant and non-replicative chimpanzee adenovirus-serotype 68 expressing a trivalent transgene coding for SARS-CoV-2 spike-nucleoprotein-polymerase (ChAd-TriCoV/Mac)
  • Recombinant and non-replicative human adenovirus-serotype 5 expressing a trivalent transgene coding for SARS-CoV-2 spike-nucleoprotein-polymerase (Ad5-TriCoV/Mac)
• Once added, these organisms are no longer subject to the New Substances Notification Regulations (Organisms) — meaning businesses who made or imported them no longer need to file new-substance notifications for these specific items.
• The order is administrative. It does not approve these organisms for any particular use, nor does it override other laws or safety review processes.

Who's affected#

• Companies and laboratories that manufacture, import or work with these specific viral strains or viral-vector products.
• Vaccine developers and biotech firms that use these strains or vectors in research or product development.
• The broader public and health systems are not directly regulated by this change; it mainly affects regulatory paperwork for businesses and researchers.
• If it is unclear whether a particular strain or product you handle is the exact one listed, contact the regulator for clarification.

Why it matters#

• For researchers and businesses, this reduces a paperwork step. These four organisms can now be used or moved without the New Substances Notification step that applies to items new to Canada.
• That can speed up laboratory work, product development or import logistics for vaccines and related research that use these specific strains or vectors.
• This administrative change is not a safety approval. It does not mean the Government of Canada endorses these organisms or replaces any separate safety reviews by health regulators.