Engineered human T‑lymphocytes added to Domestic Substances List

Summary#

Order 2020-112-12-01 Amending the Domestic Substances List adds one living organism to the federal inventory of substances used in Canada. The order was registered and came into force on September 18, 2020 and was published in the Canada Gazette on September 30, 2020.

What it does#

• Adds the living organism identified as 19477-5 N Human T lymphocytes transduced with a self-inactivating lentiviral vector, encoding an affinity optimized T cell receptor targeting the NY-ES0-1/LAGE-1a antigen to the Domestic Substances List (Part 7).
• Because it is now on the Domestic Substances List, that organism is no longer treated as “new to Canada” under the New Substances Notification rules for organisms.
• The order was made under the Canadian Environmental Protection Act, 1999. It simply records the addition; it does not by itself set new controls or approve uses.

Who's affected#

• The company, laboratory or person who manufactured or imported this specific organism into Canada and who provided the required notification information.
• Other organizations that might import, manufacture or use this exact organism in Canada. They will no longer need to follow the New Substances Notification steps that apply only to substances new to Canada.
• Regulators who keep track of substances on the Domestic Substances List.
• If it’s unclear whether a particular product or strain you handle is the same organism, you should check with your supplier or the regulator.

Why it matters#

• Being added to the Domestic Substances List means the organism is no longer considered “new” under the New Substances Notification Regulations (Organisms). That generally reduces the extra notification paperwork needed for someone to keep using or importing it.
• The addition is administrative. It does not mean the government endorses safety or grants permission for particular uses. Other laws and rules may still apply to how the organism is handled, used, or released.