Human Pathogens and Toxins Act

Marginal note:Issuance

• 18 (1) The Minister may, in accordance with the regulations, if any, issue a licence that authorizes any controlled activity in any facility if the Minister is of the opinion that the conduct of the controlled activity in the facility poses no undue risk to the health, safety or security of the public.

• Marginal note:Conditions

  (1.1) Despite subsection (1), the Minister may issue a licence only if,

  • (a) in the case that the applicant is an individual, the applicant and the biological safety officer designated for the licence are ordinarily resident in Canada; or

  • (b) in the case that the applicant is an organization, the applicant is incorporated, formed or otherwise organized in Canada and its representative and the biological safety officer designated for the licence are ordinarily resident in Canada.

• Marginal note:Debts due to His Majesty

  (1.2) In exercising the power conferred by subsection (1), the Minister may consider whether an applicant or any organization with which an applicant is or was affiliated owes an amount referred to in section 65.

• Marginal note:Licence application

  (2) An application for a licence must be filed with the Minister and made in the form and manner specified by the Minister.

• Marginal note:Refusal to issue licence

  (3) If the Minister refuses to issue a licence, the Minister must notify the applicant in writing of the reasons for the refusal.

• Marginal note:Conditions

  (4) A licence authorizes the controlled activities that are specified in it and is subject to any conditions that the Minister considers appropriate to protect the health, safety and security of the public.

• Marginal note:Conditions — transportation

  (4.1) If the Minister considers it appropriate to impose licence conditions for the conduct of controlled activities to which the Transportation of Dangerous Goods Act, 1992 applies, they must consult with the Minister of Transport and may consult with any other person the Minister considers appropriate.

• Marginal note:Failure to consult

  (4.2) The failure of the Minister to comply with the requirement to consult under subsection (4.1) does not exempt the licence holder and all persons conducting the controlled activities authorized by the licence from the obligation to comply with the licence conditions.

• Marginal note:Other conditions

  (5) A licence must also set out

  • (a) the licence holder’s name and, if applicable, the name of the individual who is designated as a representative for the licence holder;

  • (a.1) the biological safety officer’s name;

  • (b) the period during which the licence is in effect;

  • (c) a description of the facility in which controlled activities are authorized under it;

  • (d) a description of each part of the facility that is subject to section 33; and

  • (e) the toxins, human pathogens, or the risk groups of the human pathogens, in respect of which controlled activities are authorized under it.

• Marginal note:Obligation of licence holder

  (6) The licence holder shall inform all persons conducting the controlled activities authorized by the licence of its conditions.

• Marginal note:Compliance with licence conditions

  (7) A licence holder and all persons conducting the controlled activities authorized by the licence shall comply with the licence conditions.

• Marginal note:Statutory Instruments Act

  (8) A licence is not a statutory instrument within the meaning of the Statutory Instruments Act.