GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Human Pathogens and Toxins Act — H-5.67 (a)
toxin means a substance that is produced by, or derived from, a micro-organism and that (a) may or may not be listed in the registry and poses a moderate to high risk to the health of individuals; (b) is listed in the registry and 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, with the risk and minimum quantity at which it poses that risk indicated in accordance with paragraph 9(2)(a); or (c) is listed in Part 1 of the schedule. ( toxine )
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Excluded 4 This Act does not apply to (a) a human pathogen or toxin that is in an environment in which it naturally occurs if it has not been cultivated or intentionally collected or extracted, including a human pathogen or toxin that (i) is in or on a human suffering from a disease caused by that human pathogen or toxin, (ii) has been expelled by a human suffering from a disease caused by that human pathogen or toxin, or (iii) is in or on a cadaver, a body part or other human remains; or (b) a drug in dosage form or a device whose sale is permitted or otherwise authorized under the Food and Drugs Act or a human pathogen or toxin contained in such a drug or device. (c) [Repealed, 2012, c. 19, s. 752] 2009, c. 24, s. 4; 2012, c. 19, s. 752 2026, c. 3, s. 403
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Act binding on His Majesty 5 This Act is binding on His Majesty in right of Canada or a province. 2009, c. 24, s. 5 2026, c. 3, s. 404(E)
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Reasonable precautions 6 Every person who knowingly conducts any activity referred to in section 7 involving a human pathogen or toxin must take all reasonable precautions to protect the health, safety and security of the public against the risks posed by that activity. 2009, c. 24, s. 6 2026, c. 3, s. 405(E)
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Controlled activities 7 (1) A person must not knowingly conduct any controlled activity unless a licence has been issued by the Minister that authorizes the activity. Exceptions (2) Despite the definition controlled activity in subsection 3(1), the following activities are not controlled activities: (a) any activity to which the Transportation of Dangerous Goods Act, 1992 applies that involves (i) human pathogens that fall into Risk Group 2, (ii) human pathogens that fall into Risk Group 3 and are not prescribed by regulation, or (iii) toxins that are not prescribed by regulation; (b) export authorized under the Export and Import Permits Act that involves (i) human pathogens that fall into Risk Group 2, (ii) human pathogens that fall into Risk Group 3 and are not prescribed by regulation, or (iii) toxins that are not prescribed by regulation; (c) any activity to which the Transportation of Dangerous Goods Act, 1992 applies that involves the following human pathogens or toxins, unless the person who conducts the activity also conducts controlled activities to which that Act does not apply: (i) human pathogens that fall into Risk Group 3 and are prescribed by regulation, (ii) human pathogens that fall into Risk Group 4, or (iii) toxins that are prescribed by regulation; and (d) export authorized under the Export and Import Permits Act that involves the following human pathogens or toxins, unless the person who exports also conducts controlled activities to which that Act does not apply: (i) human pathogens that fall into Risk Group 3 and are prescribed by regulation, (ii) human pathogens that fall into Risk Group 4, or (iii) toxins that are prescribed by regulation. 2009, c. 24, s. 7 2026, c. 3, s. 406
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Human pathogens and toxins — schedule 8 Despite section 7, a person must not conduct any activity referred to in that section in relation to a human pathogen or toxin listed in the schedule. 2009, c. 24, s. 8 2026, c. 3, s. 406
Human Pathogens and Toxins Act — H-5.67 9.1
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. Request of Minister (2) The Minister may at any time request the advisory committee to provide advice in respect of the registry. Publication (3) The advisory committee must make available to the public the advice given to the Minister. 2026, c. 3, s. 406
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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] 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. 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). Publication (4) The advisory committee shall make available to the public the advice given to the Minister. 2009, c. 24, s. 10 2026, c. 3, s. 407
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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. 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. 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). 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. 2009, c. 24, s. 11 2026, c. 3, s. 409
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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. 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. 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. 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. 2009, c. 24, s. 12 2026, c. 3, s. 410
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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. 2009, c. 24, s. 13 2026, c. 3, s. 411
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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. 2009, c. 24, s. 14 2026, c. 3, s. 412
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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. 2009, c. 24, s. 15 2026, c. 3, s. 412
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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. 2009, c. 24, s. 16 2026, c. 3, s. 412
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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.
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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. 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. 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. 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. 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. 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. 2009, c. 24, s. 19 2026, c. 3, s. 416
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Suspension or revocation 20 (1) The Minister may suspend or revoke a licence in any of the following situations: (a) 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, safety or security of the public; (b) a licence holder who is an individual or the biological safety officer designated for the licence is not ordinarily resident in Canada; or (c) a licence holder that is an organization is incorporated, formed or otherwise organized outside Canada or that its representative or the biological safety officer designated for the licence is not ordinarily resident in Canada. 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. 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, safety and security of the public that the suspension or revocation may necessitate. 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. 2009, c. 24, s. 20 2026, c. 3, s. 417
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Notice of decision 21 (1) The Minister shall notify a licence holder by registered mail of any decision made under section 19 or 20 . 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. 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.
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Serious and imminent danger 22 (1) If the Minister is of the opinion that there is a serious and imminent danger to the health, safety or security of the public, the Minister must notify the licence holder orally of the decision to suspend or revoke their licence. 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. 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. 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. 2009, c. 24, s. 22 2026, c. 3, s. 418
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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. 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). 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, safety and security of the public pending the Minister’s final decision. 2009, c. 24, s. 23 2026, c. 3, s. 419(E)
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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. No contravention (2) No person contravenes subsection 7 (1) or section 8 by reason only that they have implemented those measures. Statutory Instruments Act (3) The measures are not statutory instruments within the meaning of the Statutory Instruments Act .
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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. 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. 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. 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. 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.
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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.
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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.
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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.
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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. Effect (2) The Minister’s final decision takes effect on the day after the day on which it is received.
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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. 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.
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List of authorized persons 31 A licence holder must establish and maintain a list of all persons authorized by the licence holder to access the facility — including remote access by a means of telecommunication — to which the licence applies, including persons holding a security clearance for that facility and visitors. The licence holder must provide the Minister with that list if requested to do so. 2009, c. 24, s. 31 2026, c. 3, s. 420
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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.
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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.
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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. 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.