Autologous CAR-T Lymphocyte Added to DSL

Summary#

Order 2022-112-09-01 Amending the Domestic Substances List adds 1 living organism to Canada’s inventory of substances, the Domestic Substances List. The change took effect when the order was registered on October 4, 2022. This means that the organism is no longer treated as a “new” substance for the purposes of federal notification rules.

What it does#

• Adds the living organism identified as 19614-2 N — Human autologous T lymphocyte expressing a chimeric antigen receptor for human B cell maturation antigen ’1’ to Part 7 of the Domestic Substances List.
• Removes the organism from the requirement to follow the New Substances Notification Regulations (Organisms) (so new-substance notification and assessment under those rules no longer apply to this specific organism).
• The Ministers of Environment and Health reviewed the information required under the Canadian Environmental Protection Act, 1999 and were satisfied the substance met the criteria for addition. The order notes no special conditions on its import or manufacture were in effect at the time of listing.
• This order is part of a pair of orders that together added 12 substances to the list (this order adds the 1 living organism).

Who's affected#

• The person or company that manufactured or imported this organism into Canada and provided the required notification to the government.
• Businesses, researchers, or clinical organizations that plan to import, manufacture or use this specific organism in Canada — they will not have to submit a new-substance notification for it anymore.
• It is not clear from the public listing which commercial products or research programs will use this organism, because the entry uses a masked identifier.

Why it matters#

• Being added to the Domestic Substances List makes it administratively simpler for the listed organism to be brought into or used in Canada, since it is no longer subject to the federal new-substance notification process for organisms.
• This change is administrative, not an endorsement: the government explicitly says the listing is not a safety approval and does not remove other laws or rules that might apply.
• The public record uses a masked name and confidential accession number, so details about the exact commercial or medical use are not publicly disclosed in the Gazette notice.