Add four organisms to Domestic Substances List

Summary#

Order 2021-112-10-01 Amending the Domestic Substances List (registered as SOR/2021-261) adds four living organisms to Canada’s Domestic Substances List under the Canadian Environmental Protection Act, 1999. The order came into force on December 21, 2021.

What it does#

• Adds the following living organisms to the Domestic Substances List:
  • Human peripheral blood mononuclear cells presenting HLA-A-02 restricted E6 and E7 epitopes of the human papillomavirus 16 (SQZ-PBMC-HPV) (added to Part 5, under “Organisms/Organismes”).
  • MicroRNA attenuated oncolytic HSV-1 recombinantly expressing IL-12, CCL4, FLT3L and antagonists of CTLA-4 and PD-1 (ONCR-177) (added to Part 5, under “Organisms/Organismes”).
  • Saccharomyces species, MeJi797 — accession 19541-9 (added to Part 7).
  • Saccharomyces species, yMHCT484 — accession 19542-0 (added to Part 7).
• The order takes effect on the day it was registered: December 21, 2021.

Who's affected#

• Companies that manufactured or imported these exact organisms into Canada.
• Research labs, clinical trial sponsors, and biotechnology firms that use or handle these materials.
• Suppliers and distributors of biological materials that carry these specific strains or products.
• The general public only indirectly — for example, patients involved in related clinical research.
• If it’s unclear who is affected: the Gazette text does not name the specific companies or institutions that provided the information.

Why it matters#

• Being listed on the Domestic Substances List means these particular organisms are treated as already present in Canadian commerce, rather than as brand-new substances for the purposes of this law. That can reduce the need for repeat “new substance” notifications for these exact organisms.
• The ministers reviewed the notifier’s information and set no conditions, so no extra CEPA conditions apply to these listings.
• This listing does not equal health or clinical approval; separate regulatory processes cover clinical trials, drug approvals and safety oversight.