Licence Holder and Licence Holder Representative

The Centre for Biosecurity is clarifying 2 important terms in relation to your Pathogen and Toxin Licence issued under the Human Pathogens and Toxins Act (the Act): licence holder and licence holder representative. Since 2015, the terms have been used interchangeably, which can cause confusion.

The licence holder, whether an individual or an organization, assumes legal responsibility for complying with the Act, the Human Pathogens and Toxins Regulations (the Regulations) and licence conditions.

Section 7 of the Act states that no person shall knowingly conduct controlled activities unless a licence has been issued by the Minister that authorizes the activity. Subsection 18(5) of the Act specifies that a licence must set out the licence holder’s name. You must therefore name a licence holder before the facility can be authorized to conduct activities regulated under the Act and the Regulations.

Meaning of Licence Holder

Under the Act, a “person” is an individual or an organization as defined in section 2 of the Criminal Code. Under the Criminal Code, an organization can be a corporation or a company, among other things.

•         On your existing licence, the name of the licence holder appears in the section “Name of Organisation.”
•         In the redesigned version of your licence, the name of the licence holder will appear in the section “Licence Holder.”

Meaning of Licence Holder Representative

The term licence holder representative does not appear in the Act or the Regulations. For administrative purposes, where the licence holder is an organization (not an individual), the licence holder representative is the individual appointed by the organization to act on its behalf to fulfill the responsibilities described in the Act and the Regulations. The licence holder representative supports the designated biological safety officer to ensure ongoing compliance with the Act, the Regulations, and licence conditions.

•         On your existing licence, the name of the licence holder representative appears in the section “Issued to.”
•         In the redesigned version of your licence, the name of the licence holder representative will appear in the section “Licence Holder Representative.”

We expect to launch the redesigned licence in April 2023, but we’ve already begun to use these terms in all of our communications. There is no action required on your end.

A Statement of Administrative Intent has been published to clarify the meaning and use of licence holder and licence holder representative in the context of the Act and Regulations.