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 and safety 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 means an activity referred to in subsection 7(1). (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 any of Schedules 2 to 4 or in Part 2 of Schedule 5; or

  • (b) is not listed in any of the Schedules 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)

  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 in Schedule 2. 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 in Schedule 3. 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 in Schedule 4. 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 listed in Schedule 1 or in Part 1 of Schedule 5. (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 whose sale is permitted or otherwise authorized under the Food and Drugs Act or a human pathogen or toxin contained in such a drug.

• (c) [Repealed, 2012, c. 19, s. 752]

Her Majesty

Marginal note:Act binding on Her Majesty

5 This Act is binding on Her 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 shall take all reasonable precautions to protect the health and safety of the public against the risks posed by that activity.

Prohibitions

Marginal note:Controlled activities

• 7 (1) No person shall knowingly conduct any of the following activities unless a licence has been issued by the Minister that authorizes the activity:

  • (a) possessing, handling or using a human pathogen or toxin;

  • (b) producing a human pathogen or toxin;

  • (c) storing a human pathogen or toxin;

  • (d) permitting any person access to a human pathogen or toxin;

  • (e) transferring a human pathogen or toxin;

  • (f) importing or exporting a human pathogen or toxin;

  • (g) releasing or otherwise abandoning a human pathogen or toxin; or

  • (h) disposing of a human pathogen or toxin.

• Marginal note:Other Acts

  (2) Subsection (1) does not apply to

  • (a) any activity to which the Transportation of Dangerous Goods Act, 1992 applies; or

  • (b) the export of human pathogens or toxins authorized under the Export and Import Permits Act.

Marginal note:Human pathogens and toxins — Schedule 5

8 Despite section 7, no person shall conduct any activity referred to in that section in relation to a human pathogen or toxin listed in Schedule 5.

Schedules 1 to 4

Marginal note:Addition of items — toxins

• 9 (1) If the Minister is of the opinion that a substance is produced by, or derived from, a micro-organism and is able to cause disease in a human, the Minister may, by regulation, add it to Schedule 1.

• Marginal note:Addition of items — human pathogens

  (2) If the Minister is of the opinion that a micro-organism, nucleic acid or protein is able to cause disease in a human, the Minister may, by regulation, add it

  • (a) to Schedule 2 if the Minister is of the opinion that it falls into Risk Group 2;

  • (b) to Schedule 3 if the Minister is of the opinion that it falls into Risk Group 3; or

  • (c) to Schedule 4 if the Minister is of the opinion that it falls into Risk Group 4.

• Marginal note:Deletion of items

  (3) The Minister may, by regulation, delete

  • (a) a substance from Schedule 1 if the Minister is of the opinion that it is not produced by, or derived from, a micro-organism or is not able to cause disease in a human; or

  • (b) a micro-organism, nucleic acid or protein from any of Schedules 2 to 4 if the Minister is of the opinion that it does not fall into the risk group to which that Schedule relates.

• Marginal note:Advisory Committee

  (4) The Minister shall consult an advisory committee established under subsection 14(1) of the Public Health Agency of Canada Act before making any regulation under subsection (1), (2) or (3).

• Marginal note:Publication

  (5) The advisory committee shall make available to the public the advice given to the Minister.

Schedule 5

Marginal note: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 Schedule 5 if the Governor in Council is of the opinion that

    • (i) it is produced by, or derived from, a micro-organism and is able to cause disease in a human, and

    • (ii) all activities referred to in section 7 should be prohibited in relation to it;

  • (b) add a micro-organism, nucleic acid or protein to Part 2 of Schedule 5 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; or

  • (c) delete a substance, micro-organism, nucleic acid or protein from any of Schedules 1 to 4 if the Governor in Council adds it to Schedule 5.

• Marginal note: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 Schedule 5 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.

• Marginal note: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).

• Marginal note:Publication

  (4) The advisory committee shall make available to the public the advice given to the Minister.

Consequences of Adding to Schedules

Marginal note:Prohibited possession — Schedules 1 to 4

• 11 (1) Within 30 days after the date of publication of a regulation made under subsection 9(1) or (2), every person who, as a result of the regulation, no longer has lawful possession of a human pathogen or toxin shall

  • (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.

• Marginal note:Prohibited possession — Schedule 5

  (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 shall dispose of it in accordance with the regulations, if any.

• Marginal note: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 in accordance with subsection (1) or (2).

Obligation to Inform Minister

Marginal note:Inadvertent release

• 12 (1) If a licence holder has reason to believe that a human pathogen or toxin has been released inadvertently from the facility in the course of an activity that is otherwise authorized by the licence, the licence holder shall, 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.

• Marginal note: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 Schedule 5, transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.

• Marginal note: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.

• Marginal note: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.

Marginal note:Disease

13 If a licence holder has reason to believe 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 shall, 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.