PEC-210A stem cell added to Domestic Substances List

Summary#

The government added a specific genetically engineered human embryonic stem cell to the Domestic Substances List. This change was made by Order 2022-112-03-01 Amending the Domestic Substances List and took effect when it was registered on April 25, 2022 (published May 11, 2022).

What it does#

• Adds the living organism named Genetically engineered human embryonic stem cells containing genomic edits with homology-directed repair-mediated insertion of the knock-in genes (PEC-210A) to Part 5 of the Domestic Substances List under the heading “Organisms/Organismes”.
• Removes the organism from the requirement to notify under the New Substances Notification Regulations (Organisms) — that is, it is no longer treated as a “new” organism for those notification rules.
• Does not create new regulatory controls, and does not mean the government endorses the organism or exempts it from any other laws that might apply.

Who's affected#

• Research labs, biotechnology companies, and any businesses that manufacture, import or work with this specific cell line (PEC-210A) in Canada are the most likely to notice the change.
• Regulators and institutions that track whether organisms are subject to new-substance notification rules.
• It is unclear from the notice whether any particular provinces, Indigenous communities, or other groups will be directly affected beyond the groups above.

Why it matters#

• Practically, adding this cell line to the Domestic Substances List makes it easier to move, use or sell in Canada because the federal “new organism” notification step no longer applies to it.
• This can speed up research and commercial work involving that cell line.
• It does not remove other legal or safety obligations — other federal, provincial, or institutional rules for handling, containment, biosafety or ethics may still apply.