Six organisms added to Domestic Substances List

Summary#

This item publishes Order 2022-112-11-01 Amending the Domestic Substances List, which adds 6 living organisms to the Domestic Substances List. The order came into force on the day it was registered (December 13, 2022) and means those organisms are no longer treated as “new” under the federal notification rules for organisms.

What it does#

• Adds the following 6 organisms to Part 5 of the Domestic Substances List:
  • Cold-adapted, temperature-sensitive and attenuated influenza A/Norway/16606/2021 (H3N2) (an A/Darwin/9/2021 (H3N2)-like virus)
  • Cold-adapted, temperature-sensitive and attenuated influenza B/Austria/1359417/2021 (B/Victoria lineage) virus
  • DGG-B — Benzene-degrading anaerobic consortium
  • DGG-T — Toluene-degrading anaerobic consortium
  • DGG-X — Xylene-degrading anaerobic consortium
  • Recombinant non-replicating adeno-associated virus serotype 9 (AAV9) vector encoding human iduronate-2-sulfatase gene (RGX-121)
• Because they are now on the list, these organisms are no longer subject to the New Substances Notification Regulations (Organisms) that apply to substances new to Canada.
• The order does not mean the government is endorsing these organisms, nor does it remove any obligations under other federal, provincial or territorial laws.

Who's affected#

• Companies and organizations that manufacture, import or plan to bring these specific organisms into Canada.
• Research labs, biotech firms and medical developers working with viral vectors such as RGX-121 or with the listed microbial consortia.
• Regulators and anyone who previously had to file notifications under the new-substance rules for these organisms.
• It is unclear from the order whether other groups (for example, specific public-health programs or environmental projects) will be directly affected beyond the change in notification status.

Why it matters#

• Practically, adding these organisms to the list removes a federal “new substance” paperwork step for anyone already making or importing them in Canada. That can reduce time and administrative effort for businesses and researchers.
• It can make it easier to move forward with manufacturing, research or clinical work involving these organisms—but it does not substitute for any safety reviews, licensing, clinical trial approvals or other regulatory requirements that might still apply.
• The change is administrative: the government explicitly says the order is not a safety approval or an exemption from other laws.