CRISPR-edited CD34+ Human Cells Added

Summary#

Order 2020-112-06-01 Amending the Domestic Substances List adds one genetically modified human cell type to the Domestic Substances List. The order took effect on the day it was registered: February 27, 2020.

What it does#

• Adds this organism to Part 5 of the Domestic Substances List: Human autologous CD34+ hematopoietic cells genetically modified by the CRISPR-Cas9 and guide RNA, disrupting the erythroid enhancer region of the B-Cell Lymphoma/Leukemia 11A (BCL11A) gene on chromosome 2.
• Removes the requirement for that organism to go through the New Substances Notification Regulations (Organisms) process for future manufacture or import in Canada (because it is now listed).
• Records that the ministers reviewed information, found the criteria for listing were met, and that no special conditions were in effect at the time of listing.
• The change was made under the authority of the Canadian Environmental Protection Act, 1999.

Who's affected#

• Companies, research labs, hospitals or clinical sponsors that manufacture or import this specific CRISPR‑modified human cell type in Canada.
• Suppliers and contract service providers who handle or ship that product.
• If you are not involved with this exact cell type, you are unlikely to notice any change.

Why it matters#

• Being on the Domestic Substances List means the organism is no longer treated as a “new” substance under the federal new‑substance notification rules. That can make it easier for businesses and researchers who work with it to bring it into Canada.
• This listing is an administrative step. It is not a safety approval, an endorsement by the government, or a blanket exemption from other laws or regulations that might apply.
• Because the organism is a CRISPR‑modified human cell type, people interested in biomedical research, clinical development, or biotechnology regulation may want to note the change.