Human Pathogens and Toxins Act (S.C. 2009, c. 24)
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Assented to 2009-06-23
Human Pathogens and Toxins Act
S.C. 2009, c. 24
Assented to 2009-06-23
An Act to promote safety and security with respect to human pathogens and toxins
SUMMARY
This enactment creates measures to promote safety and security with respect to human pathogens and toxins and all activities associated with them. It establishes a comprehensive legislative regime that extends beyond the present importation regime. It requires every person conducting activities involving human pathogens or toxins to take all reasonable measures to protect the health and safety of the public.
Preamble
Whereas the Parliament of Canada recognizes the objective of protecting the health and safety of the public;
Whereas the Parliament of Canada recognizes that human pathogens and toxins pose varying levels of risk to the health and safety 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 and safety of the public;
And 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 and safety 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
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”
« activité réglementée »
“controlled activity” means an activity referred to in subsection 7(1).
“conveyance”
« véhicule »
“conveyance” means a vessel, aircraft, train, motor vehicle, trailer or other means of transportation, including a cargo container.
“disease”
« maladie »
“disease” includes intoxication.
“human pathogen”
« agent pathogène humain »
“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.
“licence”
« permis »
“licence” means a licence issued under section 18.
“Minister”
« ministre »
“Minister” means the Minister of Health.
“person”
« personne »
“person” means an individual or an organization as defined in section 2 of the Criminal Code.
“personal information”
« renseignements personnels »
“personal information” has the same meaning as in section 3 of the Privacy Act.
“possession”
« possession »
“possession” has the same meaning as in subsection 4(3) of the Criminal Code.
“produce”
« production »
“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.
“release”
« rejet »
“release” means any discharge, anywhere, and includes leaking, spraying, depositing, dumping or vaporizing.
“Risk Group 2”
« groupe de risque 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.
“Risk Group 3”
« groupe de risque 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.
“Risk Group 4”
« groupe de risque 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.
“security clearance”
« habilitation de sécurité »
“security clearance” means a security clearance issued under section 34.
“toxin”
« toxine »
“toxin” means a substance that is listed in Schedule 1 or in Part 1 of Schedule 5.
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;
(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; or
(c) any activity that is a controlled activity within the meaning of the Assisted Human Reproduction Act.
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.
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