Determining if Cells and Cell Lines are under the authority of the Human Pathogens and Toxins Act

This Statement of Administrative Intent (SAI) is intended to clarify under which circumstances cells or cell lines are controlled under the authority of the Human Pathogens and Toxins Act (HPTA).

  1. What are Cells and Cell Lines?

    In the context of the HPTA, cells or cell lines are derived from a human or animal source and can also be produced or cultured. Cells and cell lines include all primary, secondary and immortalized cells and cell lines, as well as hybridomas that are being stored, maintained and/or cultured. Generally, cells or cell lines including oncogenic cell lines do not meet the definition of a human pathogen.

    Please note: There are other federal regulatory requirements that may apply, for example if you import animal products, such as cell lines, you may need to contact the Canadian Food Inspection Agency.

  2. When are Cells or Cell Lines under the authority of the HPTA?
    • If the cell or cell line contains an intact Risk Group 2, Risk Group 3 or Risk Group 4 human pathogen or toxin then it is controlled under the HPTA.
    • If it is unclear that the cell or cell line contains an intact Risk Group 2, Risk Group 3, or Risk Group 4 human pathogen or toxin, then a risk assessment should be conducted to identify whether the cell or cell line may contain a Risk Group 2, Risk Group 3, or Risk Group 4 human pathogen or toxin and the Agency should be consulted.
      • Note that the risk assessment should be more precautionary as the level of potential risk increases.
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