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

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.

Marginal note:Notice of decision

• 21 (1) The Minister shall notify a licence holder by registered mail of any decision made under section 19 or 20.

• Marginal note:Reasons for decision

  (2) The Minister shall give reasons for the decision in the notice and shall advise the licence holder of their right to request a review of the decision.

• Marginal note:Effective date

  (3) Subject to subsection 23(2), the Minister’s decision takes effect 31 days after the day on which the notice is received.

Marginal note:Serious and imminent danger

• 22 (1) If the Minister is of the opinion that there is a serious and imminent danger to the health or safety of the public, the Minister shall notify the licence holder orally of the decision to suspend or revoke their licence.

• Marginal note:Effective date

  (2) The decision takes effect at the time that the licence holder is notified of it and the licence holder is advised that it is effective immediately.

• Marginal note:Opportunity to make representations

  (3) The Minister is not required to give the licence holder an opportunity to make representations in respect of the decision.

• Marginal note:Notice

  (4) The Minister shall send the notice referred to in subsection 21(1) within five days after the day on which the licence holder is notified orally of the decision.

Marginal note:Review of decision

• 23 (1) Within 30 days after the day on which the notice is received, the person whose licence is affected by the decision may request in writing, stating their reasons, that the Minister refer the decision to a committee for review.

• Marginal note:Suspension

  (2) A request for a review suspends the application of the decision, unless the Minister notified the licence holder orally of the decision under the circumstances described in subsection 22(1).

• Marginal note:Measures specified by Minister

  (3) When a request for a review is made, the Minister may specify in writing any measures to be taken to protect the health and safety of the public pending the Minister’s final decision.

Marginal note:Implementation of measures

• 24 (1) A person whose licence is affected by the decision shall ensure that any measures specified by the Minister under subsection 19(3), 20(3) or 23(3) are implemented.

• Marginal note:No contravention

  (2) No person contravenes subsection 7(1) or section 8 by reason only that they have implemented those measures.

• Marginal note:Statutory Instruments Act

  (3) The measures are not statutory instruments within the meaning of the Statutory Instruments Act.

Marginal note:Referral of decision to committee

• 25 (1) On receipt of a request for a review, the Minister shall, within a reasonable time, refer the decision to which the request relates to a committee that is to consist of three individuals who have expertise in the area of human pathogens or toxins.

• Marginal note:Designation of committee members

  (2) One of the members of the committee is to be designated by the Minister and another by the person who requests the review.

• Marginal note:Chairperson

  (3) The two members designated under subsection (2) shall designate a third member of the committee, who shall be its chairperson. If they are unable to designate the third member within a reasonable time, the Minister shall make the designation.

• Marginal note:Remuneration

  (4) The members of the committee may be paid for the carrying out of their functions any remuneration that the Governor in Council may determine.

• Marginal note:Travel, living and other expenses

  (5) The members of the committee are entitled to be paid, in accordance with Treasury Board directives, reasonable travel, living and other expenses incurred in the carrying out of their functions.

Marginal note:Factors to be considered

26 A committee to which a decision is referred shall consider

• (a) the reasons for the decision;

• (b) the reasons stated by the person who requested the review; and

• (c) any representations, information or material submitted to it by the Minister or the person who requested the review.

Marginal note:Protection of information

27 The committee members shall not disclose any information or material submitted to them as part of the review to any person other than the Minister unless the disclosure is authorized by the person to whom the information or material relates or is otherwise authorized or required by law.

Marginal note:Committee’s report

28 Within 60 days after the referral of a decision to a committee, or within any longer period that the Minister may allow, the committee shall report its findings and recommendations to the Minister and to the person who requested the review.

Marginal note:Final decision

• 29 (1) Within 60 days after receiving a committee’s report, the Minister shall, taking into account its findings and recommendations,

  • (a) reconsider the decision in respect of which the report was made; and

  • (b) send the Minister’s final decision by registered mail to the person who requested the review.

• Marginal note:Effect

  (2) The Minister’s final decision takes effect on the day after the day on which it is received.

Marginal note:Duty to inform

• 30 (1) A person whose licence is suspended or revoked shall, without delay, inform all persons conducting controlled activities authorized by it of its suspension or revocation.

• Marginal note:Return of revoked licence

  (2) A person whose licence is revoked shall return it by registered mail to the Minister as soon as feasible after the Minister’s decision takes effect or, if the decision is reviewed, as soon as feasible after the Minister’s final decision takes effect.

Access to Facility to Which Licence Applies

Marginal note:List of authorized persons

31 A licence holder shall establish and maintain a list of all persons authorized by the licence holder to access the facility to which the licence applies, including persons holding a security clearance for that facility and visitors. The licence holder shall provide the Minister with that list if requested to do so.

Marginal note:Obligation to inform Minister

32 If a licence holder decides to prohibit the holder of a security clearance from having access to the facility to which the licence applies, the licence holder shall, without delay, inform the Minister in writing of their decision.

Security Clearances

Marginal note:Access to facilities

33 No person shall enter the part of a facility in which controlled activities are authorized in relation to human pathogens that fall into Risk Group 3 or Risk Group 4 and are prescribed by regulation or toxins prescribed by regulation unless

• (a) they hold a security clearance for that part of the facility; or

• (b) they are, in accordance with the regulations, if any, accompanied and supervised by a person who holds a security clearance for that part of the facility.

Marginal note:Issuance, suspension and revocation

• 34 (1) The Minister may, in accordance with the regulations, issue a security clearance to any individual or suspend or revoke a security clearance. The Minister shall notify the individual concerned in writing of the decision.

• Marginal note:Agreement

  (2) The Minister may, by way of an agreement, authorize any federal department or agency to issue, suspend or revoke security clearances and section 35 applies with any necessary modifications.

Marginal note:Reconsideration of decision

• 35 (1) If the Minister refuses to issue a security clearance or suspends or revokes a security clearance, the individual concerned may, within 30 days after the day on which the notice is received, request in writing that the Minister reconsider the decision.

• Marginal note:Request for reconsideration

  (2) The request for reconsideration must set out

  • (a) the decision that is the subject of the request;

  • (b) the reasons for the request, including any new information that the individual concerned wishes the Minister to consider; and

  • (c) any information prescribed by regulation.

• Marginal note:Opportunity to make representations

  (3) On receipt of a request made in accordance with this section, the Minister shall give the individual concerned a reasonable opportunity to make representations.

• Marginal note:Confirmation or variation of decision

  (4) Within a reasonable time after representations have been made or an opportunity to do so has been given, the Minister shall reconsider the decision, in accordance with the regulations, if any, and confirm or vary it.

• Marginal note:Notice

  (5) The Minister shall notify the individual concerned in writing of the decision made following the reconsideration.

Biological Safety Officers

Marginal note:Designation

• 36 (1) An applicant shall, before a licence may be issued, designate an individual as a biological safety officer for the requested licence. The individual designated may also be the applicant.

• Marginal note:Obligations not limited

  (2) A designation does not have the effect of limiting the obligations of the licence holder or any other person under this Act.

• Marginal note:Qualifications

  (3) An individual may be designated as a biological safety officer only if the individual has the qualifications set out in the regulations.

• Marginal note:Effect of designation

  (4) A designation takes effect on the day on which the designated individual provides the Minister with their written consent to the designation or the day on which the individual begins to act as a biological safety officer, whichever is earlier.

• Marginal note:Powers and functions

  (5) The biological safety officer may exercise the powers and shall carry out the functions set out in the regulations.

• Marginal note:Replacement

  (6) If an individual ceases to act as a biological safety officer, the licence holder shall, without delay, designate another individual and inform the Minister of the new designation.