Human Pathogens and Toxins Act (S.C. 2009, c. 24)
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Act current to 2026-05-26 and last amended on 2026-03-26. Previous Versions
AMENDMENTS NOT IN FORCE
— 2026, c. 3, s. 402(3)
402 (3) Subsection 3(1) of the Act is amended by adding the following in alphabetical order:
- foreign entity
foreign entity means a foreign economic entity, foreign entity, or foreign state as those terms are defined in subsection 2(1) of the Foreign Interference and Security of Information Act. (entité étrangère)
- terrorist group
terrorist group has the same meaning as in subsection 83.01(1) of the Criminal Code. (groupe terroriste)
— 2026, c. 3, s. 409(4)
409 (4) The portion of subsection 11(4) of the Act before paragraph (a) is replaced by the following:
Defence
(4) If a human pathogen or toxin is listed in the registry, then no person may be convicted of an offence or subjected to an administrative monetary penalty — in relation to that human pathogen or toxin — for the contravention of any provision of this Act or the regulations unless it is proved that, at the time of the alleged contravention,
— 2026, c. 3, s. 413
413 Section 15 of the Act is replaced by the following:
Other incidents
14.1 If a licence holder has reasonable grounds to suspect that an incident meets all of the conditions below, the licence holder must inform the Minister of the incident and provide them, without delay, with the information related to the incident that the Minister requires that is under the licence holder’s control:
(a) the incident is not one referred to in subsection 12(1) or (2) or section 13 or 14;
(b) it involves human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins prescribed by regulation;
(c) it is specified in regulations.
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, 14 or 14.1 has occurred, the person must, without delay, inform the licence holder.
— 2026, c. 3, s. 414
414 Section 16 of the Act is replaced by the following:
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 the following proceedings that are subsequently instituted against them:
(a) proceedings in respect of a violation enforced by an administrative monetary penalty; or
(b) criminal proceedings, 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.
— 2026, c. 3, ss. 415(3), (8), (9)
415 (3) Section 18 of the Act is amended by adding the following after subsection (2):
Information
(2.1) An application for a licence to authorize controlled activities in relation to human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins that are prescribed by regulation must include the information prescribed by regulation and make reference, in accordance with the regulations, to the following:
(a) any contribution or other funding that originates from outside Canada that the applicant received or expects to receive in relation to their activities;
(b) if the applicant is an organization, any person or foreign entity that has or is seeking to have any direct or indirect ownership or influence over the organization that would result in control in fact of the organization; and
(c) if the applicant is an individual, any person or foreign entity that has or is seeking to have any direct or indirect influence over any activities of the applicant that are governed by this Act or the regulations.
(8) Subsection 18(5) of the Act is amended by adding the following after paragraph (d):
(d.1) a description of each part of the facility that is prescribed by the regulations made for the purposes of section 33.1;
(9) Section 18 of the Act is amended by adding the following after subsection (6):
Obligation of the licence holder — information
(6.1) If a licence authorizes controlled activities in relation to human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins that are prescribed by regulation, the licence holder must provide the Minister with the information prescribed by regulation and inform them, in accordance with the regulations, of the following:
(a) any contribution or other funding that originates from outside Canada that the licence holder received or expects to receive in relation to their activities;
(b) if the licence holder is an organization, any person or foreign entity that has or is seeking to have any direct or indirect ownership or influence over the organization that would result in control in fact of the organization; and
(c) if the licence holder is an individual, any person or foreign entity that has or is seeking to have any direct or indirect influence over any activities of the licence holder that are governed by this Act or the regulations.
— 2026, c. 3, s. 421
421 Section 33 of the Act is replaced by the following
Access to facilities — security clearance
33 An individual must not enter — to conduct controlled activities — 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 in relation to toxins prescribed by regulation unless they hold a security clearance for that part of the facility.
Access — compliance with regulations
33.1 (1) Except in accordance with the regulations, any individual who does not conduct controlled activities authorized in relation to human pathogens that fall into Risk Group 3 or Risk Group 4 and are prescribed by regulation or in relation to toxins prescribed by regulation is prohibited from
(a) entering a facility in which controlled activities are authorized in relation to those human pathogens or toxins;
(b) remotely accessing that facility by a means of telecommunication; or
(c) accessing by any means, sensitive information, as defined by regulation, in relation to those human pathogens or toxins.
Non-application
(2) Paragraphs (1)(a) and (b) do not apply to an individual who holds a security clearance referred to in section 33 that authorizes entry to part of a facility referred to in paragraph (1)(a) 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 in relation to toxins prescribed by regulation.
Restriction
(3) Moreover, if an individual holds a security clearance that does not authorize them to enter certain parts of a facility referred to in paragraph (1)(a) 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 in relation to toxins prescribed by regulation, the individual may enter those parts or remotely access them by a means of telecommunication only if they do so in accordance with the regulations.
— 2026, c. 3, s. 422
422 The Act is amended by adding the following after section 35:
Minister’s power — individual
35.1 (1) Despite sections 33 and 33.1, the Minister may, on any conditions that they consider appropriate, exempt any individual from the requirement to hold a security clearance under section 33 or to comply with the regulations referred to in section 33.1 if the Minister is of the opinion that the exemption
(a) poses no undue risk to the health, safety or security of the public; and
(b) is warranted by reason of exigent circumstances related to the health, safety or security of the public.
Duration of order
(2) An exemption ceases to have effect on the earliest of the following days:
(a) the day that is specified by the Minister in the exemption;
(b) the day on which the Minister revokes the exemption; or
(c) the day that is one year after the day on which the exemption takes effect.
Report and review by committee
(3) Within 30 days of exercising the power to exempt under subsection (1), the Minister must cause a report of the exercise, including the Minister’s reasons for granting the exemption, to be referred for review to the standing committee of each House of Parliament that normally considers matters related to national security.
— 2026, c. 3, s. 431
431 The Act is amended by adding the following after section 52:
Administrative Monetary Penalties
Violations
Administrative monetary penalties
52.1 (1) Every person who contravenes a provision designated under paragraph (12)(a) commits a violation and is liable to an administrative monetary penalty of not more than $50,000 in the case of an individual and $250,000 in the case of any other person.
Purpose of penalty
(2) The purpose of the penalty is to promote compliance with the provisions of this Act or the regulations and not to punish.
Minister’s powers — notice of violation
(3) The Minister may
(a) establish the form of notices of violations;
(b) designate individuals, or classes of individuals, who are authorized to issue notices of violations; and
(c) establish, in respect of each violation, a short-form description to be used in notices of violation.
Notice of violation
(4) If an individual designated under subsection (3) has reasonable grounds to believe that a person has committed a violation, the designated individual may issue a notice of violation and cause it to be served on the person. The notice of violation must include the information prescribed by regulation.
Continuing violation
(5) A violation that is committed or continued on more than one day constitutes a separate violation in respect of each day on which it is committed or continued.
Limitation
(6) Proceedings in respect of a violation may be instituted no later than two years after the day on which the subject matter of the proceedings becomes known to the Minister.
Publication
(7) After proceedings in respect of a violation are ended, the Minister may make public the nature of the violation, the name of the person who committed it and the amount of the penalty imposed.
Directors, officers and agents or mandatries
(8) If a person other than an individual commits a violation under this Act or the regulations, any of the person’s directors, officers or agents or mandataries who directed, authorized, assented to, acquiesced in or participated in the commission of the violation is a party to the violation, whether or not the person is proceeded against under this Act or the regulations.
Employees, agents or mandataries
(9) In a proceeding for a violation under this Act or the regulations, it is sufficient proof of the violation to establish that it was committed by the employee of the person named in the notice of violation, who is acting within the scope of their employment, or the agent or mandatary of the person named in the notice of violation, who is acting within the scope of their authority, whether or not the employee, agent or mandatary is identified or proceeded against for the violation, unless the person named in the violation establishes that
(a) the violation was committed without the persons’s knowledge or consent; and
(b) the person exercised all due diligence to prevent its commission.
Violation or offence
(10) If any act or omission can be proceeded with as a violation or as an offence, the Minister may commence proceedings in respect of that act or omission as a violation or recommend that it be proceeded with as an offence, but proceeding with it as a violation precludes proceeding with it as an offence, and proceeding with it as an offence precludes proceeding with it as a violation.
Violation not offences
(11) For greater certainty, a violation is not an offence and, accordingly, section 126 of the Criminal Code does not apply in respect of a violation.
Regulations
(12) The Governor in Council may make regulations respecting an administrative monetary penalties scheme, including regulations
(a) designating any of the following as violations:
(i) non-compliance with the requirements in subsection 12(1), paragraph 12(2)(a) or section 13, 14, 14.1 or 15 that are in respect of notification or the provision of information, as the case may be,
(ii) the contravention of subsection 18(2.1), (6) or (6.1),
(iii) the contravention of subsection 18(7) in relation to any licence conditions that are in respect of notification and the provision of information,
(iv) the contravention of section 30, 31 or 32,
(v) the contravention of the requirement in subsection 36(1) to designate an individual who holds the qualifications set out in regulations, as a biological safety officer,
(vi) the contravention of subsection 36(3) in relation to any powers, duties and functions that are in respect of notification and the provision of information,
(vii) the contravention of subsection 36(5) or 36.1(4),
(viii) the contravention of subsection 38(3),
(ix) the contravention of subsection 40.2(2), 41(3.1) or (5) or 44(2),
(x) the contravention of a provision of a regulation made under paragraph 66(1)(k), and
(xi) non-compliance with any other requirements that are in respect of notification and the provision of information that are prescribed by regulation;
(b) respecting the classification of each violation;
(c) respecting the information referred to in subsection (4);
(d) respecting the proceedings in respect of a violation; and
(e) respecting the penalties, including in relation to
(i) the determination of, or the method of determining the penalty applicable for each violation, and
(ii) the payment of the penalty imposed.
Right to request review
(13) Any regulation made under any of paragraphs (12)(a) to (e) must provide that a person named in the notice of violation has the right to request a review of the decision that the person has committed a violation or of the penalty imposed, or both.
Penalties
Payment
52.2 (1) If the person named in the notice of violation pays, in the time and manner specified in the notice, the amount of the penalty set out in the notice,
(a) they are deemed to have committed the violation in respect of which the amount is paid;
(b) the Minister must accept that amount as complete satisfaction of the penalty in respect of the violation; and
(c) the proceedings commenced in respect of the violation are ended.
Alternatives
(2) Instead of paying the amount of the penalty set out in the notice, the person may, in the time and manner specified in the notice,
(a) if the amount of the penalty set out in the notice is $5,000 or more, request to enter into a compliance agreement with the Minister that ensures the person’s compliance with the provision to which the violation relates; or
(b) request a review by the Minister, in accordance with the regulations, of the decision that the person has committed a violation or of the penalty imposed, or both.
Compliance Agreements
Entering into compliance agreements
52.3 (1) After considering a request by a person named in the notice of violation, the Minister may enter into a compliance agreement with that person on any terms and conditions that are satisfactory to the Minister. The terms and conditions may
(a) include a provision for the deposit of reasonable security, in a form and amount satisfactory to the Minister, as a guarantee that the person will comply with the compliance agreement; and
(b) provide for the reduction, in whole or in part, of the penalty for the violation.
Deeming
(2) A person who enters into a compliance agreement with the Minister is, on doing so, deemed to have committed the violation in respect of which the compliance agreement was entered into.
Notice of compliance
(3) A notice from the Minister that they are satisfied that a person who has entered into a compliance agreement has complied with it ends the proceedings commenced in respect of the violation. Any security given by the person under the compliance agreement must then be returned to the person.
Notice of default
(4) If the Minister is of the opinion that a person who has entered into a compliance agreement has not complied with it, the Minister must cause a notice of default to be provided to the person informing them that
(a) instead of being liable to pay the amount of the penalty set out in the compliance agreement, the person is liable to pay, in the time and manner specified in the notice of default, an amount that is twice the amount of the penalty set out in the notice of violation, and for greater certainty, subsection 52.1(1) does not apply in respect of that amount; or
(b) the security is forfeited to His Majesty in right of Canada.
Effect of notice of default
(5) Once provided with the notice of default, the person may not deduct from the amount set out in the notice of default any amount they spent under the compliance agreement and
(a) the person is liable to pay the amount set out in the notice of default in the time and manner specified in the notice of default; or
(b) if the notice provides for the forfeiture of the security given under the compliance agreement, that security is forfeited to His Majesty in right of Canada and the proceedings commenced in respect of the violation are ended.
Effect of payment
(6) If the person pays the amount set out in the notice of default in the time and manner specified in the notice of default, the Minister must accept the amount as complete satisfaction of the amount owing in respect of the violation and the proceedings commenced in respect of the violation are ended.
Refusal to enter into compliance agreement
52.4 (1) If the Minister refuses to enter into a compliance agreement is liable to pay, in the time and manner specified in the notice of violation, the amount of the penalty set out in the notice of violation.
Effect of payment
(2) If a person pays the amount set out in the notice of violation in the specified time and manner,
(a) they are deemed to have committed the violation in respect of which the amount is paid;
(b) the Minister must accept the amount as complete satisfaction of the penalty in respect of the violation; and
(c) the proceedings commenced in respect of the violation are ended.
Default of payment
(3) If a person does not pay the amount set out in the notice of violation in the specified time and manner, they are deemed to have committed the violation identified in the notice of violation.
Rules About Violations
Due diligence
52.5 (1) A person must not be found to be liable for a violation under this Act if they establish that they exercised due diligence to prevent its commission.
Non-application
(2) Despite subsection (1), a person to whom the Minister causes a notice of default to be provided under subsection 52.3(4) does not have a defence by reason that the person exercised due diligence to comply with the compliance agreement.
Common law principles
(3) Every rule and principle of the common law that renders any circumstance a justification or excuse in relation to a charge for an offence under this Act or the regulations applies in respect of a violation to the extent that it is not inconsistent with this Act and the regulations.
— 2026, c. 3, s. 433
433 The Act is amended by adding the following after section 55:
Communicating sensitive information
56 Every person who knowingly and without lawful authority communicates sensitive information as prescribed by regulation to a foreign entity or terrorist group is guilty of an indictable offence and liable to imprisonment for life.
— 2026, c. 3, s. 436(3)
436 (3) Section 59 of the Act is amended by adding the following after paragraph (b):
(c) section 56;
— 2026, c. 3, s. 441(2)
441 (2) Section 65 of the Act is amended by striking out “and” at the end of paragraph (b) and adding the following after paragraph (c):
(d) any administrative monetary penalty required to be paid under this Act;
(e) any amount that is required to be paid under a compliance agreement entered into under subsection 52.3(1);
(f) any amount set out in a notice referred to in paragraph 52.3(4)(a); and
(g) the amount of any reasonable expenses incurred in attempting to recover an amount referred to in paragraph (d), (e) or (f).
— 2026, c. 3, ss. 442(4), (6) to (9), (12) and (14)
442 (4) Subsection 66(1) of the Act is amended by adding the following after paragraph (e):
(e.1) respecting incidents referred to in section 14.1;
(6) Paragraph 66(1)(f) of the Act is replaced by the following:
(f) specifying the human pathogen and toxins for the purposes of subparagraphs 7(2)(c)(i) and (iii) and (d)(i) and (iii), section 14.1, subsections 18(2.1) and (6.1) and sections 33 and 33.1;
(7) The portion of paragraph 66(1)(g) of the Act before subparagraph (i) is replaced by the following:
(g) respecting security clearances for the purposes of section 33 and regulations made under paragraph (g.1), including
(8) Subsection 66(1) of the Act is amended by adding the following after paragraph (g):
(g.1) respecting, for the purposes of section 33.1, the conditions to be met, which could include requirements for a security clearance, to
(i) enter a facility in which controlled activities are authorized in relation to human pathogens or toxins that are referred to in paragraph 33.1(1)(a),
(ii) remotely access a facility by a means of telecommunication, or
(iii) access sensitive information referred to in paragraph 33.1(1)(c);
(g.2) respecting the management of any sensitive information;
(9) Paragraph 66(1)(h) of the Act is repealed.
(12) Subsection 66(1) of the Act is amended by adding the following after paragraph (i.1):
(i.2) respecting sensitive information for the purpose of section 56;
(14) Subsection 66(1) of the Act is amended by adding the following after paragraph (l):
(l.1) respecting information that is to be provided to the Minister under subsection 18(2.1) or (6.1);
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