Human Pathogens and Toxins Act (S.C. 2009, c. 24)

Marginal note:Advisory Committee

• 9.1 (1) An advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act is to, on a periodic basis, provide advice to the Minister in respect of the registry.

• Marginal note:Request of Minister

  (2) The Minister may at any time request the advisory committee to provide advice in respect of the registry.

• Marginal note:Publication

  (3) The advisory committee must make available to the public the advice given to the Minister.

Schedule

Marginal note:Addition of items

• 10 (1) The Governor in Council may, by regulation, on the Minister’s recommendation,

  • (a) add a substance to Part 1 of the schedule if the Governor in Council is of the opinion that

    • (i) it is produced by, or derived from, a micro-organism and poses a moderate to high risk to

      • (A) the health of individuals, or

      • (B) the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, and

    • (ii) all activities referred to in section 7 should be prohibited in relation to it; or

  • (b) add a micro-organism, nucleic acid or protein to Part 2 of the schedule if the Governor in Council is of the opinion that

    • (i) it is able to cause disease in a human, and

    • (ii) all activities referred to in section 7 should be prohibited in relation to it.

  • (c) [Repealed, 2026, c. 3, s. 407]

• Marginal note:Deletion of items

  (2) The Governor in Council may, by regulation, on the Minister’s recommendation, delete a substance, micro-organism, nucleic acid or protein from the schedule if the Governor in Council is of the opinion that it is in the public interest to allow one or more of the activities referred to in section 7 to be authorized in relation to that substance, micro-organism, nucleic acid or protein.

• Marginal note:Advisory Committee

  (3) The Minister shall consult an advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act before making any recommendation under subsection (1) or (2).

• Marginal note:Publication

  (4) The advisory committee shall make available to the public the advice given to the Minister.

Consequences of Updating the Registry or Schedule

Marginal note:Prohibited possession — update

• 11 (1) Within 30 days after the date that an update to the registry under subsection 9(1) is publicly accessible, every person who, as a result of the update to the registry, no longer has lawful possession of a human pathogen or toxin must

  • (a) dispose of it in accordance with the regulations, if any;

  • (b) transfer it to a facility where controlled activities in relation to it are authorized; or

  • (c) obtain from the Minister a licence, or a variation of the conditions of their existing licence, authorizing possession of it.

• Marginal note:Prohibited possession — schedule

  (2) Within 14 days after the date of publication of a regulation made under subsection 10(1), every person who, as a result of the regulation, no longer has lawful possession of a human pathogen or toxin must dispose of it in accordance with the regulations, if any.

• Marginal note:No contravention

  (3) No person contravenes subsection 7(1) or section 8 by reason only that they possess a human pathogen or toxin in the circumstances described in subsection (1) or (2) if they transfer or dispose of it or obtain a licence or a variation of their existing licence authorizing possession of it, in accordance with subsection (1) or (2).

• Marginal note:Defence

  (4) If a human pathogen or toxin is listed in the registry, then no person may be convicted of an offence — in relation to that human pathogen or toxin — for the contravention of this Act or the regulations unless it is proved that, at the time of the alleged contravention,

  • (a) the registry with the human pathogen or toxin listed in it was reasonably accessible to the person;

  • (b) the human pathogen or toxin was listed in the registry; and

  • (c) the registry indicated, in relation to the human pathogen or toxin,

    • (i) the risk group into which the human pathogen falls,

    • (ii) if the toxin poses a moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, the references referred to in paragraph 9(2)(a), or

    • (iii) the minimum quantity at which the toxin poses a moderate to high risk to the health of individuals, if any.

Obligation to Inform Minister

Marginal note:Inadvertent release

• 12 (1) If a licence holder has reasonable grounds to suspect that a human pathogen or toxin has been released inadvertently from a facility in the course of a controlled activity authorized by the licence, the licence holder must, without delay, inform the Minister of the release and provide the Minister with the information referred to in subsection (3) that is under the licence holder’s control.

• Marginal note:Inadvertent production

  (2) If a person is in possession of a human pathogen or toxin in contravention of subsection 7(1) or section 8 as a result of the inadvertent production of that human pathogen or toxin in the course of an activity that is otherwise lawful, the person shall

  • (a) without delay, inform the Minister of the inadvertent production and provide the Minister with the information referred to in subsection (3) that is under the person’s control; and

  • (b) dispose of the inadvertently produced human pathogen or toxin in accordance with the regulations, if any, or, if it is not listed in the schedule, transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.

• Marginal note:Information

  (3) The information that is to be provided under subsections (1) and (2) is the following:

  • (a) any information that supports the conclusion that a human pathogen or toxin has been released or produced;

  • (b) the name of the human pathogen or toxin released or produced;

  • (c) the quantity released or produced;

  • (d) the place and time of the release or production; and

  • (e) any other information relating to the release or production that the Minister may require.

• Marginal note:No contravention

  (4) No person contravenes subsection 7(1) or section 8 by reason only that they possess a human pathogen or toxin in the circumstances described in subsection (2) if they transfer or dispose of it in accordance with that subsection.

Marginal note:Disease

13 If a licence holder has reasonable grounds to suspect that an incident involving a human pathogen or toxin that is in their possession has, or may have, caused disease in an individual, the licence holder must, without delay, inform the Minister of the incident and provide the Minister with the following information that is under the licence holder’s control:

• (a) a description of the incident;

• (b) the name of the human pathogen or toxin; and

• (c) any other information relating to the incident that the Minister may require.

Marginal note:Missing human pathogen or toxin

14 If a licence holder has reasonable grounds to suspect that a human pathogen or toxin that was in their possession has been stolen or is otherwise missing, the licence holder must, without delay, inform the Minister and provide the Minister with any information relating to the incident that is under their control and that the Minister may require. The licence holder must also take reasonable measures to locate the missing human pathogen or toxin.

Marginal note:Person conducting controlled activities

15 If a person conducting controlled activities under the authority of a licence has reasonable grounds to suspect that any of the incidents described in subsection 12(1) or (2) or section 13 or 14 has occurred, the person must, without delay, inform the licence holder.

Marginal note:Use of information

16 No information provided under sections 12 to 15 by a licence holder or a person conducting controlled activities under the authority of a licence may be used or received against that person in any criminal proceedings that are subsequently instituted against them, other than with respect to a contravention of section 17 or in respect of an allegation that the licence holder or person conducting controlled activities has shown wanton or reckless disregard for the health, safety or security of other persons.

Marginal note:False or misleading information

17 No person shall knowingly communicate or cause to be communicated to the Minister false or misleading information in relation to a matter under this Act or the regulations.

Licences

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.

Marginal note:Variation of licence

• 19 (1) The Minister may, in accordance with the regulations, if any, on the Minister’s own initiative or on the application of a licence holder, vary a licence if the conditions referred to in subsections 18(1) and (1.1) are satisfied.

• Marginal note:Exception

  (1.1) Despite subsection (1), the Minister may, if they are of the opinion that exigent circumstances exist, vary the licence even if the conditions referred to in subsection 18(1.1) are not satisfied.

• Marginal note:Time period

  (1.2) A licence that has been varied under subsection (1.1) is valid for a period of up to 90 days after the day of the variance.

• Marginal note:Debts owed to His Majesty

  (1.3) In exercising the power conferred by subsection (1), the Minister may consider whether the licence holder, any organization with which a licence holder is or was affiliated or a person conducting controlled activities under the authority of the licence owes an amount referred to in section 65.

• Marginal note:Representations

  (2) The Minister may vary the licence on the Minister’s own initiative only if the Minister first gives the licence holder a reasonable opportunity to make representations.

• Marginal note:Measures specified by Minister

  (3) If the Minister varies the licence, the Minister may specify in writing any measures to be taken to protect the health, safety and security of the public that the variation in conditions may necessitate.