SCHEDULE 5

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 Schedule 5 if the Governor in Council is of the opinion that

    • (i) it is produced by, or derived from, a micro-organism and is able to cause disease in a human, and

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

  • (b) add a micro-organism, nucleic acid or protein to Part 2 of Schedule 5 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; or

  • (c) delete a substance, micro-organism, nucleic acid or protein from any of Schedules 1 to 4 if the Governor in Council adds it to Schedule 5.

• 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 Schedule 5 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 ADDING TO SCHEDULES

Marginal note:Prohibited possession — Schedules 1 to 4

• 11. (1) Within 30 days after the date of publication of a regulation made under subsection 9(1) or (2), every person who, as a result of the regulation, no longer has lawful possession of a human pathogen or toxin shall

  • (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 5

  (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 shall 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 in accordance with subsection (1) or (2).

OBLIGATION TO INFORM MINISTER

Marginal note:Inadvertent release

• 12. (1) If a licence holder has reason to believe that a human pathogen or toxin has been released inadvertently from the facility in the course of an activity that is otherwise authorized by the licence, the licence holder shall, 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 Schedule 5, 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 reason to believe 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 shall, 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 reason to believe that a human pathogen or toxin that was in their possession has been stolen or is otherwise missing, the licence holder shall, 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 shall also take reasonable measures to locate the missing human pathogen or toxin.

Marginal note:Person conducting activities

15. If a person conducting activities under the authority of a licence has reason to believe that any of the incidents described in subsection 12(1) or (2) or section 13 or 14 has occurred, the person shall, 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 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.

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 or safety of the public.

• 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 shall 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 and safety of the public.

• Marginal note:Other conditions

  (5) A licence must also set out

  • (a) the licence holder’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 conditions

• 19. (1) The Minister may, on the Minister’s own initiative or on the application of a licence holder, vary the licence conditions if the Minister is of the opinion that the variation poses no undue risk to the health or safety of the public.

• Marginal note:Representations

  (2) The Minister may vary the licence conditions 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 conditions, the Minister may specify in writing any measures to be taken to protect the health and safety of the public that the variation in conditions may necessitate.

Marginal note:Suspension or revocation of licence

• 20. (1) The Minister may suspend or revoke a licence if the Minister is of the opinion that a controlled activity authorized by the licence is conducted in a manner that is contrary to this Act or the regulations or poses an undue risk to the health or safety of the public.

• Marginal note:Opportunity to make representations

  (2) The Minister may suspend or revoke a licence 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 suspends or revokes a licence, the Minister may specify in writing any measures to be taken to protect the health and safety of the public that the suspension or revocation may necessitate.

• Marginal note:Disposal

  (4) Subject to the measures specified by the Minister, the licence holder shall, within five days after the day on which the Minister’s decision to suspend or revoke the licence takes effect,

  • (a) dispose of the human pathogen or toxin in accordance with the regulations, if any; or

  • (b) transfer the human pathogen or toxin to a facility where controlled activities in relation to the human pathogen or toxin are authorized.