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

Short Title

Marginal note:Short title

1 This Act may be cited as the Human Pathogens and Toxins Act.

Purpose of the Act

Marginal note:Purpose

2 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.

Interpretation and Application

Marginal note:Definitions

• 3 (1) The following definitions apply in this Act.

  controlled activity

  controlled activity, in respect of a human pathogen or toxin, means any of the following activities:

  • (a) possessing, handling or using it;

  • (b) producing it;

  • (c) storing it;

  • (d) permitting any person access to it;

  • (e) transferring it;

  • (f) importing or exporting it;

  • (g) releasing or otherwise abandoning it; or

  • (h) disposing of it. (activité réglementée)

  conveyance

  conveyance means a vessel, aircraft, train, motor vehicle, trailer or other means of transportation, including a cargo container. (véhicule)

  disease

  disease includes intoxication. (maladie)

  human pathogen

  human pathogen means a micro-organism, nucleic acid or protein that

  • (a) is listed in the registry or in Part 2 of the schedule; or

  • (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)

  licence

  licence means a licence issued under section 18. (permis)

  Minister

  Minister means the Minister of Health. (ministre)

  person

  person means an individual or an organization as defined in section 2 of the Criminal Code. (personne)

  personal information

  personal information has the same meaning as in section 3 of the Privacy Act. (renseignements personnels)

  possession

  possession has the same meaning as in subsection 4(3) of the Criminal Code. (possession)

  produce

  produce, in respect of a human pathogen or toxin, means to create it by any method or process, including

  • (a) by manufacturing, cultivating, developing, reproducing or synthesizing it; or

  • (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)

  registry

  registry means the registry established under subsection 9(1). (registre)

  release

  release means any discharge, anywhere, and includes leaking, spraying, depositing, dumping or vaporizing. (rejet)

  Risk Group 2

  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)

  Risk Group 3

  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)

  Risk Group 4

  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)

  security clearance

  security clearance means a security clearance issued under section 34. (habilitation de sécurité)

  toxin

  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)

• Marginal note:Included

  (2) For the purposes of this Act, a human pathogen or toxin includes

  • (a) a substance that contains a human pathogen or toxin; and

  • (b) any synthetic form of the human pathogen or toxin.

Marginal note: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]

His Majesty

Marginal note:Act binding on His Majesty

5 This Act is binding on His Majesty in right of Canada or a province.

Obligation

Marginal note: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.

Prohibitions

Marginal note: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.

• Marginal note: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.

Marginal note: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.

Registry

Marginal note:Registry

• 9 (1) The Minister must establish and update a registry that

  • (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

  • (b) may list

    • (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

    • (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.

• Marginal note:Minister’s obligation

  (2) The Minister must indicate in the registry

  • (a) in the case of a substance referred to in paragraph (1)(a), that

    • (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

    • (ii) the minimum quantity at which, in the opinion of the Minister, it poses that risk; and

  • (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.

• Marginal note:Minimum quantity

  (3) 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.

• Marginal note:Deletion of items

  (4) 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).

• Marginal note:Amendments to the registry

  (5) The Minister must, in the registry,

  • (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;

  • (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);

  • (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

  • (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).

• Marginal note:Amendment to the registry — name

  (6) The Minister may amend the registry by modifying the name of a human pathogen or toxin listed in the registry.

• Marginal note:Accessibility of the registry

  (7) The Minister must make the registry accessible to the public by electronic means and by any other means that the Minister considers appropriate.

• Marginal note:Delegation

  (8) 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).

• Marginal note:Non-application

  (9) 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).

• Marginal note:Exemption from Statutory Instruments Act

  (10) The registry is exempt from sections 3, 5 and 11 of the Statutory Instruments Act.