Licence Holder and Licence Holder Representative: Defining terms in the context of the Human Pathogens and Toxins Act  

This Statement of Administrative Intent intends to clarify the meaning of "Licence Holder" and "Licence Holder Representative" in the application of the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR).

Conducting Controlled Activities

Section 7 of the HPTA 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 HPTA specifies that a licence must set out the licence holder's name. A licence holder must therefore be named before a facility can be authorized to conduct activities regulated under the HPTA and the HPTR.

Meaning of "Licence Holder"

Under the HPTA, a "person" means 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^{Footnote 1}. Therefore, the individual or organization named as the licence holder assumes legal responsibility for complying with the HPTA, HPTR and licence conditions.

Meaning of "Licence Holder Representative"

The term "licence holder representative" does not appear in the HPTA or HPTR. For administrative purposes, where the licence holder is an organization and not an individual, the Public Health Agency of Canada's Centre for Biosecurity requests that the licence holder appoint an individual as the licence holder representative to act on its behalf in fulfilling the responsibilities described in the HPTA and the HPTR. The licence holder representative will also support the designated biological safety officer (i.e. the established primary contact) to ensure ongoing compliance with the HPTA, HPTR and licence conditions. The functions of a biological safety officer can be found in section 9 of the HPTR.