Part IIOrderPublished: November 23, 2022

New genetically modified human cells and fish added

Order 2022-112-10-01 Amending the Domestic Substances List: SOR/2022-233

This order adds specific genetically modified human cells and several genetically modified Puntigrus tetrazona fish lines to the Domestic Substances List under the Canadian Environmental Protection Act, 1999. The change records these organisms as existing in Canada and affects researchers, importers and regulators tracking notifications and oversight; it came into force on registration.

Published
November 23, 2022
Department
Unavailable
Section
Order 2022-112-10-01 Amending the Domestic Substances List
Comment deadline
Unavailable
Effective date
November 7, 2022
Publication part
Part II

Summary

Summary#

This is Order 2022-112-10-01 Amending the Domestic Substances List: SOR/2022-233. It adds several genetically modified human cells and fish lines to the Domestic Substances List under the Canadian Environmental Protection Act, 1999, and took effect when it was registered on November 7, 2022.

What it does#

  • Adds one entry to Part 5 (organisms):
    • Genetically engineered human CD34+ enriched hematopoietic stem-progenitor cells (HSPC) lacking expression of the CD33 myeloid protein (VOR33)
  • Adds several entries to Part 7 (numbered items), including:
    • 19619-7 — a genetically modified Puntigrus tetrazona descended from Green Barb 0 with a construct expressing a green fluorescent protein
    • 19620-8 — a genetically modified Puntigrus tetrazona descended from Red Barb 0 with a construct expressing a red fluorescent protein
    • 19621-9 — a genetically modified Puntigrus tetrazona descended from Purple Barb 0 with a construct expressing a far‑red fluorescent protein
    • 19622-0 — a genetically modified Puntigrus tetrazona descended from Orange Barb 0 with a construct expressing a yellow fluorescent protein
    • 19624-2Recombinant human T lymphocyte expressing a CD19‑specific chimeric antigen receptor (CC‑97540)
  • The Order says these additions come into force on the day the Order was registered (November 7, 2022).

Who's affected#

  • Researchers and companies that manufacture, import, or work with the listed organisms in Canada.
  • Regulators and public health or environmental officials who track what organisms are on the Domestic Substances List.
  • The wider public, especially people interested in biotechnology oversight, environmental risks, or clinical uses of modified human cells.
  • If it’s unclear whether a specific person or facility is affected, the source does not say; the likely primary impact is on those handling these exact organisms.

Why it matters#

  • Being added to the Domestic Substances List means these specific organisms are recorded by the federal government as existing in Canada as of November 7, 2022.
  • That affects how the government tracks and manages new versus existing organisms under the Canadian Environmental Protection Act, 1999.
  • For labs and companies, the listing can change what notifications or reviews are needed before manufacturing or importing these organisms.
  • For the public, it shows the types of genetically modified organisms that are present in Canada and that federal review processes for them have reached a conclusion (according to the Order).

Key topics

Canadian Environmental Protection Act, 1999CEPADomestic Substances ListDSLGenetically engineered human CD34+ enriched hematopoietic stem-progenitor cells (VOR33)Recombinant human T lymphocyte expressing a CD19-specific chimeric antigen receptor (CC-97540)genetically modified Puntigrus tetrazona (GB-0, green fluorescent protein)genetically modified Puntigrus tetrazona (RB-0, red fluorescent protein)genetically modified Puntigrus tetrazona (PB-0, far-red fluorescent protein)genetically modified Puntigrus tetrazona (OB-0, yellow fluorescent protein)genetically modified organismsbiotechnologyEnvironment and Climate Change CanadaHealth Canada

Source: Canada Gazette

Official source