Human Pathogens and Toxins Act

Marginal note:Regulations

• 66 (1) The Governor in Council may make regulations for carrying out the purposes of this Act, including regulations

  • (a) defining any term that is used but not defined in this Act;

  • (a.1) respecting the safety and security of activities to which this Act or the regulations made under it apply;

  • (a.2) respecting the conduct of controlled activities, including in relation to

    • (i) containment levels for human pathogens or toxins, and

    • (ii) the decontamination of material, equipment, places, conveyances and persons contaminated by human pathogens or toxins;

  • (b) respecting licensing, including the conditions that must be met for a licence to be issued, the conditions that must be complied with under a licence, the renewal, suspension and revocation of a licence and the variation of an existing licence;

  • (c) respecting facilities in which controlled activities are authorized, including

    • (i) the location, design, construction, layout and upgrading of those facilities,

    • (ii) the material and equipment at those facilities,

    • (iii) heating, ventilation, air conditioning and air handling systems,

    • (iv) biological safety cabinets, and

    • (v) security requirements in relation to information technology;

  • (d) respecting access, including remote access by a means of telecommunication, to facilities in which controlled activities are authorized, including

    • (i) the conditions to be met by persons to obtain access to those facilities, and

    • (ii) the screening of persons accessing those facilities;

  • (e) prescribing the time when a document sent under this Act is to be considered to have been received;

  • (f) specifying the human pathogens and toxins for the purposes of subparagraphs 7(2)(c)(i) and (iii) and (d)(i) and (iii) and section 33;

  • (g) respecting security clearances required under section 33, including

    • (i) the conditions to be met by an applicant for a security clearance,

    • (ii) the issuance of security clearances, as well as their suspension and revocation, and

    • (iii) the reconsideration of a decision to refuse, suspend or revoke a security clearance;

  • (h) respecting the accompaniment and supervision, within the part of a facility described in section 33, of persons who do not hold a security clearance;

  • (i) respecting the qualifications, powers, duties and functions of biological safety officers;

  • (i.1) specifying the powers, duties and functions of the representative for the purposes of subsection 36.1(2);

  • (j) respecting the establishment, content and maintenance of inventories of human pathogens and toxins, as well as the provision of reports on those inventories;

  • (k) respecting the preparation, content and maintenance of any documents necessary for the administration of this Act and the regulations, as well as the provision of those documents to the Minister;

  • (l) respecting the provision of information to the Minister that is necessary for the administration of this Act and the regulations;

  • (m) respecting the collection, use and disclosure by the Minister of personal information and confidential business information;

  • (n) exempting, on any conditions that the Governor in Council deems appropriate, any person or class of persons, any activity or any human pathogen or toxin from the application of any provision of this Act or the regulations if the Governor in Council is of the opinion that the exemption is in the public interest and poses no undue risk to the health, safety or security of the public; and

  • (o) prescribing any other matter that by this Act is to be prescribed.

  • (p) [Repealed, 2026, c. 3, s. 442]

• Marginal note:Levels of risk

  (1.1) In making regulations, the Governor in Council shall take into account the varying levels of risk posed by human pathogens — determined by whether they fall into Risk Group 2, Risk Group 3 or Risk Group 4 — and those posed by toxins.

• Marginal note:Distinctions

  (2) A regulation may establish classes of persons, facilities, activities, human pathogens and toxins and distinguish among those classes.