Human Pathogens and Toxins Act

Whereas the Parliament of Canada recognizes the objective of protecting the health, safety and security of the public;Whereas the Parliament of Canada recognizes that human pathogens and toxins pose varying levels of risk to the health, safety and security of the public;Whereas the Parliament of Canada recognizes that a lack of full scientific certainty regarding the risks posed by certain human pathogens and toxins is not to be used as a reason to postpone measures that protect the health, safety and security of the public;Whereas the Parliament of Canada recognizes that human pathogens and toxins evolve and can be altered and that new human pathogens and toxins appear continually, therefore creating unique challenges in meeting the objective of protecting the health, safety and security of the public;And whereas the Parliament of Canada recognizes that preventing the theft of sensitive information in relation to human pathogens and toxins contributes to the objective of protecting the health, safety and security of the public;Now, therefore, Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

Short Title

Purpose of the Act

Interpretation and Application

His Majesty

Obligation

Prohibitions

Registry

Schedule

Consequences of Updating the Registry or Schedule

Obligation to Inform Minister

Licences

Access to Facility to Which Licence Applies

Security Clearances

Biological Safety Officers

Licence Holder Representative

Exemptions

Information

Administration and Enforcement

Offences and Punishment

Debts

Regulatory Powers

Transitional Provisions

Coming into Force

Prohibited Human Pathogens and Toxins (Subsection 3(1), section 8, subsections 9(4), 10(1) and 10(2) and paragraph 12(2)(b))

ToxinsHuman Pathogens

Schedule 2

Schedule 3

Schedule 4

Schedule 5

Related provisions

— 2022, c. 17, s. 76For greater certainty, but subject to sections 77 and 78, the amendments made by this Act also apply with respect to proceedings that are ongoing on the day on which this Act comes into force. — 2022, c. 17, par. 77(2)(g)Each of the following provisions, as it read immediately before the day on which this Act comes into force, continues to apply with respect to an application made for a warrant under the provision if the application is submitted, and no decision has been made in respect of the application, before that day:subsection 42(4) of the Human Pathogens and Toxins Act; — 2022, c. 17, s. 78.1The Minister of Justice must, no later than three years after the day on which this Act receives royal assent, initiate one or more independent reviews on the use of remote proceedings in criminal justice matters that must include an assessment of whether remote proceedingsenhance, preserve or adversely affect access to justice;maintain fundamental principles of the administration of justice; andadequately address the rights and obligations of participants in the criminal justice system, including accused persons.The Minister of Justice must, no later than five years after the day on which a review is initiated, cause a report on the review — including any findings or recommendations resulting from it — to be laid before each House of Parliament. — 2022, c. 17, s. 78.2At the start of the fifth year after the day on which this Act receives royal assent, the provisions enacted or amended by this Act are to be referred to a committee of the Senate and a committee of the House of Commons that may be designated or established for the purpose of reviewing the provisions.The committees to which the provisions are referred are to review them and the use of remote proceedings in criminal justice matters and submit reports to the Houses of Parliament of which they are committees, including statements setting out any changes to the provisions that they recommend. — 2026, c. 3, s. 453The words and expressions used in this section and sections 454 and 455 have the same meaning as in the Human Pathogens and Toxins Act.On the day on which section 406 comes into force, any person who, under paragraph 7(2)(c) or (d) of the Human Pathogens or Toxins Act, conducts controlled activities that are not authorized by their licence, must, within 90 days after that day, either apply to the Minister to vary their licence to authorize those activities or stop conducting those activities.A person referred to in subsection (2) does not contravene subsection 7(1) of the Human Pathogens or Toxins Act if they comply with subsection (2). — 2026, c. 3, s. 454After the day on which section 423 comes into force, a licence holder that is an organization must, without delay, provide the Minister with the name of its representative. — 2026, c. 3, s. 455The validity period of a licence may be extended for a period of up to 60 days beginning on the day on which this Act receives royal assent ifthe validity period of the licence ends within 30 days after the day on which this Act receives royal assent; andon the day on which this Act receives royal assent, the licence holder, its representative, if any, or the biological safety officer designated for the licence do not meet the requirements referred to in subsection 18(1.1) of the Human Pathogen and Toxins Act.

Amendments not in force

— 2026, c. 3, s. 402(3)Subsection 3(1) of the Act is amended by adding the following in alphabetical order: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 has the same meaning as in subsection 83.01(1) of the Criminal Code. (groupe terroriste) — 2026, c. 3, s. 409(4)The portion of subsection 11(4) of the Act before paragraph (a) is replaced by the following: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. 413Section 15 of the Act is replaced by the following: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:the incident is not one referred to in subsection 12(1) or (2) or section 13 or 14;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;it is specified in regulations.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. 414Section 16 of the Act is replaced by the following: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:proceedings in respect of a violation enforced by an administrative monetary penalty; orcriminal 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)Section 18 of the Act is amended by adding the following after subsection (2):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:any contribution or other funding that originates from outside Canada that the applicant received or expects to receive in relation to their activities;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; andif 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.Subsection 18(5) of the Act is amended by adding the following after paragraph (d):a description of each part of the facility that is prescribed by the regulations made for the purposes of section 33.1;Section 18 of the Act is amended by adding the following after subsection (6):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:any contribution or other funding that originates from outside Canada that the licence holder received or expects to receive in relation to their activities;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; andif 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. 421Section 33 of the Act is replaced by the followingAn 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.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 fromentering a facility in which controlled activities are authorized in relation to those human pathogens or toxins;remotely accessing that facility by a means of telecommunication; oraccessing by any means, sensitive information, as defined by regulation, in relation to those human pathogens or toxins.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.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. 422The Act is amended by adding the following after section 35: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 exemptionposes no undue risk to the health, safety or security of the public; andis warranted by reason of exigent circumstances related to the health, safety or security of the public.An exemption ceases to have effect on the earliest of the following days:the day that is specified by the Minister in the exemption;the day on which the Minister revokes the exemption; orthe day that is one year after the day on which the exemption takes effect.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. 431The Act is amended by adding the following after section 52:Administrative Monetary PenaltiesViolationsEvery 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.The purpose of the penalty is to promote compliance with the provisions of this Act or the regulations and not to punish.The Minister mayestablish the form of notices of violations;designate individuals, or classes of individuals, who are authorized to issue notices of violations; andestablish, in respect of each violation, a short-form description to be used in notices of violation.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.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.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.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.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.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 thatthe violation was committed without the persons’s knowledge or consent; andthe person exercised all due diligence to prevent its commission.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.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.The Governor in Council may make regulations respecting an administrative monetary penalties scheme, including regulationsdesignating any of the following as violations: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,the contravention of subsection 18(2.1), (6) or (6.1),the contravention of subsection 18(7) in relation to any licence conditions that are in respect of notification and the provision of information,the contravention of section 30, 31 or 32,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,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,the contravention of subsection 36(5) or 36.1(4),the contravention of subsection 38(3),the contravention of subsection 40.2(2), 41(3.1) or (5) or 44(2),the contravention of a provision of a regulation made under paragraph 66(1)(k), andnon-compliance with any other requirements that are in respect of notification and the provision of information that are prescribed by regulation;respecting the classification of each violation;respecting the information referred to in subsection (4);respecting the proceedings in respect of a violation; andrespecting the penalties, including in relation tothe determination of, or the method of determining the penalty applicable for each violation, andthe payment of the penalty imposed.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.PenaltiesIf 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,they are deemed to have committed the violation in respect of which the amount is paid;the Minister must accept that amount as complete satisfaction of the penalty in respect of the violation; andthe proceedings commenced in respect of the violation are ended.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,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; orrequest 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 AgreementsAfter 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 mayinclude 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; andprovide for the reduction, in whole or in part, of the penalty for the violation.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.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.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 thatinstead 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; orthe security is forfeited to His Majesty in right of Canada.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 andthe 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; orif 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.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.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.If a person pays the amount set out in the notice of violation in the specified time and manner,they are deemed to have committed the violation in respect of which the amount is paid;the Minister must accept the amount as complete satisfaction of the penalty in respect of the violation; andthe proceedings commenced in respect of the violation are ended.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 ViolationsA 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.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.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. 433The Act is amended by adding the following after section 55: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)Section 59 of the Act is amended by adding the following after paragraph (b):section 56; — 2026, c. 3, s. 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):any administrative monetary penalty required to be paid under this Act;any amount that is required to be paid under a compliance agreement entered into under subsection 52.3(1);any amount set out in a notice referred to in paragraph 52.3(4)(a); andthe 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)Subsection 66(1) of the Act is amended by adding the following after paragraph (e):respecting incidents referred to in section 14.1;Paragraph 66(1)(f) of the Act is replaced by the following: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;The portion of paragraph 66(1)(g) of the Act before subparagraph (i) is replaced by the following:respecting security clearances for the purposes of section 33 and regulations made under paragraph (g.1), includingSubsection 66(1) of the Act is amended by adding the following after paragraph (g):respecting, for the purposes of section 33.1, the conditions to be met, which could include requirements for a security clearance, toenter 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),remotely access a facility by a means of telecommunication, oraccess sensitive information referred to in paragraph 33.1(1)(c);respecting the management of any sensitive information;Paragraph 66(1)(h) of the Act is repealed.Subsection 66(1) of the Act is amended by adding the following after paragraph (i.1):respecting sensitive information for the purpose of section 56;Subsection 66(1) of the Act is amended by adding the following after paragraph (l):respecting information that is to be provided to the Minister under subsection 18(2.1) or (6.1);