Human Pathogens and Toxins Act
An Act to promote safety and security with respect to human pathogens and toxins
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Sections676
- 1Short title
This Act may be cited as the Human Pathogens and Toxins Act.
- 2Purpose
The purpose of this Act is to establish a safety and security regime to protect the health, safety and security of the public against the risks posed by human pathogens and toxins.
- 3Definitions
- 3(1)
The following definitions apply in this Act.
- 3(1)[p4]
controlled activity, in respect of a human pathogen or toxin, means any of the following activities:
- 3(1)[p4](a)
possessing, handling or using it;
- 3(1)[p5]
- 3(1)[p4](b)
producing it;
- 3(1)[p6]
- 3(1)[p4](c)
storing it;
- 3(1)[p7]
- 3(1)[p4](d)
permitting any person access to it;
- 3(1)[p7](a)
- 3(1)[p4](e)
transferring it;
- 3(1)[p7](b)
- 3(1)[p10]
- 3(1)[p4](f)
importing or exporting it;
- 3(1)[p11]
- 3(1)[p4](g)
releasing or otherwise abandoning it; or
- 3(1)[p12]
- 3(1)[p4](h)
disposing of it. (activité réglementée)
- 3(1)[p13]
conveyance means a vessel, aircraft, train, motor vehicle, trailer or other means of transportation, including a cargo container. (véhicule)
- 3(1)[p14]
disease includes intoxication. (maladie)
- 3(1)[p15]
human pathogen means a micro-organism, nucleic acid or protein that
- 3(1)[p15](a)
is listed in the registry or in Part 2 of the schedule; or
- 3(1)[p15](b)
is not listed in the registry or in Part 2 of the schedule but falls into Risk Group 2, Risk Group 3 or Risk Group 4. (agent pathogène humain)
- 3(1)[p18]
licence means a licence issued under section 18. (permis)
- 3(1)[p19]
Minister means the Minister of Health. (ministre)
- 3(1)[p20]
person means an individual or an organization as defined in section 2 of the Criminal Code. (personne)
- 3(1)[p21]
personal information has the same meaning as in section 3 of the Privacy Act. (renseignements personnels)
- 3(1)[p22]
possession has the same meaning as in subsection 4(3) of the Criminal Code. (possession)
- 3(1)[p23]
produce, in respect of a human pathogen or toxin, means to create it by any method or process, including
- 3(1)[p23](a)
by manufacturing, cultivating, developing, reproducing or synthesizing it; or
- 3(1)[p23](b)
by converting or refining a substance, micro-organism, nucleic acid or protein, or by using any other means of altering its physical or chemical properties. (production)
- 3(1)[p26]
registry means the registry established under subsection 9(1). (registre)
- 3(1)[p27]
release means any discharge, anywhere, and includes leaking, spraying, depositing, dumping or vaporizing. (rejet)
- 3(1)[p28]
Risk Group 2 means a category of human pathogens that pose a moderate risk to the health of individuals and a low risk to public health and includes the human pathogens listed under Risk Group 2 in the registry. They are able to cause serious disease in a human but are unlikely to do so. Effective treatment and preventive measures are available and the risk of spread of disease caused by those pathogens is low. (groupe de risque 2)
- 3(1)[p29]
Risk Group 3 means a category of human pathogens that pose a high risk to the health of individuals and a low risk to public health and includes the human pathogens listed under Risk Group 3 in the registry. They are likely to cause serious disease in a human. Effective treatment and preventive measures are usually available and the risk of spread of disease caused by those pathogens is low. (groupe de risque 3)
- 3(1)[p30]
Risk Group 4 means a category of human pathogens that pose a high risk to the health of individuals and a high risk to public health and includes the human pathogens listed under Risk Group 4 in the registry. They are likely to cause serious disease in a human. Effective treatment and preventive measures are not usually available and the risk of spread of disease caused by those pathogens is high. (groupe de risque 4)
- 3(1)[p31]
security clearance means a security clearance issued under section 34. (habilitation de sécurité)
- 3(1)[p32]
toxin means a substance that is produced by, or derived from, a micro-organism and that
- 3(1)[p32](a)
may or may not be listed in the registry and poses a moderate to high risk to the health of individuals;
- 3(1)[p32](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
- 3(1)[p32](c)
is listed in Part 1 of the schedule. (toxine)
- 3(2)Included
For the purposes of this Act, a human pathogen or toxin includes
- 3(2)(a)
a substance that contains a human pathogen or toxin; and
- 3(2)(b)
any synthetic form of the human pathogen or toxin.
- 7(1)(a)
- 4Excluded
This Act does not apply to
- 7(1)(b)
- 4(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
- 7(1)(c)
- 4(a)(i)
is in or on a human suffering from a disease caused by that human pathogen or toxin,
- 7(1)(d)
- 4(a)(ii)
has been expelled by a human suffering from a disease caused by that human pathogen or toxin, or
- 7(1)(e)
- 4(a)(iii)
is in or on a cadaver, a body part or other human remains; or
- 7(1)(f)
- 4(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.
- 7(1)(g)
- 4(c)Repealed
[Repealed, 2012, c. 19, s. 752]
- 7(1)(h)
- 5Act binding on His Majesty
This Act is binding on His Majesty in right of Canada or a province.
- 6Reasonable precautions
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.
- 7Controlled 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.
- 7(2)Exceptions
Despite the definition controlled activity in subsection 3(1), the following activities are not controlled activities:
- 7(2)(a)
any activity to which the Transportation of Dangerous Goods Act, 1992 applies that involves
- 7(2)(a)(i)
human pathogens that fall into Risk Group 2,
- 7(2)(a)(ii)
human pathogens that fall into Risk Group 3 and are not prescribed by regulation, or
- 7(2)(a)(iii)
toxins that are not prescribed by regulation;
- 7(2)(b)
export authorized under the Export and Import Permits Act that involves
- 9(2)(c)
- 7(2)(b)(i)
human pathogens that fall into Risk Group 2,
- 7(2)(b)(ii)
human pathogens that fall into Risk Group 3 and are not prescribed by regulation, or
- 9(3)(a)
- 7(2)(b)(iii)
toxins that are not prescribed by regulation;
- 9(3)(b)
- 7(2)(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:
- 7(2)(c)(i)
human pathogens that fall into Risk Group 3 and are prescribed by regulation,
- 7(2)(c)(ii)
human pathogens that fall into Risk Group 4, or
- 7(2)(c)(iii)
toxins that are prescribed by regulation; and
- 7(2)(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:
- 7(2)(d)(i)
human pathogens that fall into Risk Group 3 and are prescribed by regulation,
- 7(2)(d)(ii)
human pathogens that fall into Risk Group 4, or
- 7(2)(d)(iii)
toxins that are prescribed by regulation.
- 8Human pathogens and toxins — schedule
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.
- 9Registry
- 9(1)
The Minister must establish and update a registry that
- 9(1)(a)
lists any substance that, in the opinion of the Minister, is produced by, or derived from, a micro-organism 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; and
- 9(1)(b)
may list
- 9(1)(b)(i)
any micro-organism, nucleic acid or protein if they are of the opinion that it falls into Risk Group 2, Risk Group 3 or Risk Group 4, or
- 9(1)(b)(ii)
any substance if they are of the opinion that it is produced by, or derived from a micro-organism and it poses a moderate to high risk to the health of individuals.
- 9(2)Minister’s obligation
The Minister must indicate in the registry
- 9(2)(a)
in the case of a substance referred to in paragraph (1)(a), that
- 9(2)(a)(i)
it 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, and
- 9(2)(a)(ii)
the minimum quantity at which, in the opinion of the Minister, it poses that risk; and
- 9(2)(b)
in the case of a micro-organism, nucleic acid or protein referred to in subparagraph (1)(b)(i), the risk group into which, in the opinion of the Minister, it falls.
- 9(3)Minimum quantity
The Minister may, for any substance referred to in subparagraph (1)(b)(ii) that is listed in the registry, identify in the registry the minimum quantity at which, in the opinion of the Minister, the substance poses the risk referred to in that subparagraph.
- 9(4)Deletion of items
The Minister must delete from the registry a micro-organism, nucleic acid, protein or substance if the Governor in Council adds it to the schedule under subsection 10(1).
- 9(5)Amendments to the registry
The Minister must, in the registry,
- 9(5)(a)
amend the risk group of a human pathogen if the Minister is of the opinion that it falls into a risk group that is different from the one under which it is listed in the registry;
- 9(5)(b)
add the references referred to in paragraph (2)(a) if the Minister is of the opinion that the toxin that is listed in the registry poses a risk referred to in paragraph (1)(a);
- 9(5)(c)
remove the references referred to in paragraph (2)(a) if the Minister is of the opinion that the toxin that is listed in the registry does not pose a risk referred to in paragraph (1)(a); and
- 9(5)(d)
amend the minimum quantity that is listed for a toxin if the Minister is of the opinion that it is not the minimum quantity at which the toxin poses a risk referred to in paragraph (1)(a) or subparagraph (1)(b)(ii).
- 9(6)Amendment to the registry — name
The Minister may amend the registry by modifying the name of a human pathogen or toxin listed in the registry.
- 9(7)Accessibility of the registry
The Minister must make the registry accessible to the public by electronic means and by any other means that the Minister considers appropriate.
- 9(8)Delegation
The Minister may, subject to any terms and conditions that they specify, delegate to an officer or employee of the Public Health Agency of Canada established under section 3 of the Public Health Agency of Canada Act, any of the powers that the Minister is authorized to exercise or any of the duties and functions that they are authorized to perform under subsections (1) to (7).
- 9(9)Non-application
For greater certainty, section 5 of the Public Health Agency of Canada Act does not apply if the Minister delegates any of the powers they are authorized to exercise or any of the duties and functions that they are authorized to perform under subsection (8).
- 9(10)Exemption from Statutory Instruments Act
The registry is exempt from sections 3, 5 and 11 of the Statutory Instruments Act.
- 9.1Advisory 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.
- 9.1(2)Request of Minister
The Minister may at any time request the advisory committee to provide advice in respect of the registry.
- 9.1(3)Publication
The advisory committee must make available to the public the advice given to the Minister.
- 10Addition of items
- 10(1)
The Governor in Council may, by regulation, on the Minister’s recommendation,
- 10(1)(a)
add a substance to Part 1 of the schedule if the Governor in Council is of the opinion that
- 10(1)(a)(i)
it is produced by, or derived from, a micro-organism and poses a moderate to high risk to
- 10(1)(a)(i)(A)
the health of individuals, or
- 10(1)(a)(i)(B)
the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, and
- 10(1)(a)(ii)
all activities referred to in section 7 should be prohibited in relation to it; or
- 10(1)(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
- 10(1)(b)(i)
it is able to cause disease in a human, and
- 10(1)(b)(ii)
all activities referred to in section 7 should be prohibited in relation to it.
- 10(1)(c)Repealed
[Repealed, 2026, c. 3, s. 407]
- 10(2)Deletion of items
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.
- 10(3)Advisory Committee
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).
- 10(4)Publication
The advisory committee shall make available to the public the advice given to the Minister.
- 11Prohibited 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
- 11(1)(a)
dispose of it in accordance with the regulations, if any;
- 11(1)(b)
transfer it to a facility where controlled activities in relation to it are authorized; or
- 11(1)(c)
obtain from the Minister a licence, or a variation of the conditions of their existing licence, authorizing possession of it.
- 11(2)Prohibited possession — schedule
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.
- 11(3)No contravention
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).
- 11(4)Defence
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,
- 11(4)(a)
the registry with the human pathogen or toxin listed in it was reasonably accessible to the person;
- 11(4)(b)
the human pathogen or toxin was listed in the registry; and
- 11(4)(c)
the registry indicated, in relation to the human pathogen or toxin,
- 11(4)(c)(i)
the risk group into which the human pathogen falls,
- 11(4)(c)(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
- 11(4)(c)(iii)
the minimum quantity at which the toxin poses a moderate to high risk to the health of individuals, if any.
- 12Inadvertent 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.
- 12(2)Inadvertent production
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
- 12(2)(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
- 12(2)(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.
- 12(3)Information
The information that is to be provided under subsections (1) and (2) is the following:
- 12(3)(a)
any information that supports the conclusion that a human pathogen or toxin has been released or produced;
- 12(3)(b)
the name of the human pathogen or toxin released or produced;
- 12(3)(c)
the quantity released or produced;
- 12(3)(d)
the place and time of the release or production; and
- 12(3)(e)
any other information relating to the release or production that the Minister may require.
- 12(4)No contravention
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.
- 13Disease
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:
- 13(a)
a description of the incident;
- 13(b)
the name of the human pathogen or toxin; and
- 13(c)
any other information relating to the incident that the Minister may require.
- 14Missing human pathogen or toxin
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.
- 15Person conducting controlled activities
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.
- 16Use of information
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.
- 17False or misleading information
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.
- 18Issuance
- 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, safety or security of the public.
- 18(1.1)Conditions
Despite subsection (1), the Minister may issue a licence only if,
- 18(1.1)(a)
in the case that the applicant is an individual, the applicant and the biological safety officer designated for the licence are ordinarily resident in Canada; or
- 18(1.1)(b)
in the case that the applicant is an organization, the applicant is incorporated, formed or otherwise organized in Canada and its representative and the biological safety officer designated for the licence are ordinarily resident in Canada.
- 18(1.2)Debts due to His Majesty
In exercising the power conferred by subsection (1), the Minister may consider whether an applicant or any organization with which an applicant is or was affiliated owes an amount referred to in section 65.
- 18(2)Licence application
An application for a licence must be filed with the Minister and made in the form and manner specified by the Minister.
- 18(3)Refusal to issue licence
If the Minister refuses to issue a licence, the Minister must notify the applicant in writing of the reasons for the refusal.
- 18(4)Conditions
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, safety and security of the public.
- 18(4.1)Conditions — transportation
If the Minister considers it appropriate to impose licence conditions for the conduct of controlled activities to which the Transportation of Dangerous Goods Act, 1992 applies, they must consult with the Minister of Transport and may consult with any other person the Minister considers appropriate.
- 18(4.2)Failure to consult
The failure of the Minister to comply with the requirement to consult under subsection (4.1) does not exempt the licence holder and all persons conducting the controlled activities authorized by the licence from the obligation to comply with the licence conditions.
- 18(5)Other conditions
A licence must also set out
- 18(5)(a)
the licence holder’s name and, if applicable, the name of the individual who is designated as a representative for the licence holder;
- 18(5)(a.1)
the biological safety officer’s name;
- 18(5)(b)
the period during which the licence is in effect;
- 18(5)(c)
a description of the facility in which controlled activities are authorized under it;
- 18(5)(d)
a description of each part of the facility that is subject to section 33; and
- 18(5)(e)
the toxins, human pathogens, or the risk groups of the human pathogens, in respect of which controlled activities are authorized under it.
- 18(6)Obligation of licence holder
The licence holder shall inform all persons conducting the controlled activities authorized by the licence of its conditions.
- 18(7)Compliance with licence conditions
A licence holder and all persons conducting the controlled activities authorized by the licence shall comply with the licence conditions.
- 18(8)Statutory Instruments Act
A licence is not a statutory instrument within the meaning of the Statutory Instruments Act.
- 19Variation 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.
- 19(1.1)Exception
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.
- 19(1.2)Time period
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.
- 19(1.3)Debts owed to His Majesty
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.
- 19(2)Representations
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.
- 19(3)Measures specified by Minister
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.
- 20Suspension or revocation
- 20(1)
The Minister may suspend or revoke a licence in any of the following situations:
- 20(1)(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;
- 20(1)(b)
a licence holder who is an individual or the biological safety officer designated for the licence is not ordinarily resident in Canada; or
- 20(1)(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.
- 20(2)Opportunity to make representations
The Minister may suspend or revoke a licence only if the Minister first gives the licence holder a reasonable opportunity to make representations.
- 20(3)Measures specified by Minister
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.
- 20(4)Disposal
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,
- 20(4)(a)
dispose of the human pathogen or toxin in accordance with the regulations, if any; or
- 20(4)(b)
transfer the human pathogen or toxin to a facility where controlled activities in relation to the human pathogen or toxin are authorized.