CD19 CAR T Cells Added to Inventory

Summary#

Order 2021-112-09-01 Amending the Domestic Substances List adds one living organism to Canada’s inventory of substances. The change took effect on July 28, 2021, and was published in the Canada Gazette on August 18, 2021. The organism added is Recombinant human T lymphocytes expressing a CD19-specific chimeric antigen receptor (listed in Part 7 of the Domestic Substances List).

What it does#

• Adds the living organism Recombinant human T lymphocytes expressing a CD19-specific chimeric antigen receptor to Part 7 of the Domestic Substances List.
• Removes the organism from the set of things considered “new” under the notification rules, so it is no longer subject to the New Substances Notification Regulations (Organisms) for people who have already manufactured or imported it in the prescribed way.
• Confirms the order is now in force (it became effective on the day it was registered: July 28, 2021).

Who's affected#

• The most directly affected parties are companies or people who manufacture, import, or sell this living organism in Canada — for example, biotechnology firms, medical suppliers, and research institutions that work with it.
• Regulators and compliance staff at federal departments who track which substances are on the national inventory.
• The general public or consumers are unlikely to notice a direct difference; the source does not say who uses the organism or where it is used.

Why it matters#

• Being on the Domestic Substances List means the organism is no longer treated as a “new substance” for the narrow purpose of the notification rules under the Canadian Environmental Protection Act, 1999. That can make it administratively easier for businesses that already handled the organism to continue doing so.
• The order does not introduce new safety rules, and it is not a government endorsement or an exemption from other laws that might still apply (such as health or clinical regulations).