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

Marginal note:Admissibility

• 52 (1) An analyst’s certificate or report is admissible in evidence in any prosecution for an offence under this Act if it

  • (a) appears to be signed by the analyst;

  • (b) states that a thing has been analyzed or examined by the analyst; and

  • (c) states the results of that analysis or examination.

  In the absence of evidence to the contrary, the certificate or report is proof of the statements contained in it without proof of the signature or official character of the person appearing to have signed it.

• Marginal note:Attendance of analyst required

  (2) The party against whom a certificate or report is produced may, with leave of the court, require the analyst’s attendance for the purpose of cross-examination.

• Marginal note:Notice of intention to produce certificate or report

  (3) No certificate or report may be admitted in evidence unless, before the trial, the party intending to produce it has given reasonable notice of that intention, together with a copy of the certificate or report, to the party against whom it is intended to be produced.

Offences and Punishment

Marginal note:General

53 Subject to sections 54 to 58, every person who contravenes this Act or the regulations is guilty of an offence and liable, on summary conviction,

• (a) in the case of a contravention with respect to a human pathogen that falls into Risk Group 2,

  • (i) for a first offence, to a fine of not more than $50,000, and

  • (ii) for a subsequent offence, to a fine of not more than $250,000 or to imprisonment for a term of not more than three months, or to both; and

• (b) in all other cases,

  • (i) for a first offence, to a fine of not more than $250,000 or to imprisonment for a term of not more than three months, or to both, and

  • (ii) for a subsequent offence, to a fine of not more than $500,000 or to imprisonment for a term of not more than six months, or to both.

Marginal note:Breach of duty

54 Every person who contravenes section 6 and, as a result, creates a risk to the health or safety of the public is guilty of an indictable offence and liable to imprisonment for a term of not more than two years.

Marginal note:Wanton or reckless breach of duty

55 Every person who contravenes section 6 and who shows wanton or reckless disregard for the health or safety of other persons and, as a result, creates a risk to the health or safety of the public is guilty of an indictable offence and liable to imprisonment for a term of not more than five years.

Marginal note:Contravention of subsection 7(1) or 18(7)

56 Every person who contravenes subsection 7(1) or 18(7) with respect to a human pathogen that falls into Risk Group 3 or Risk Group 4 or a toxin is guilty of an offence and liable

• (a) on conviction on indictment, for a first offence, to a fine of not more than $500,000 or to imprisonment for a term of not more than six months, or to both, and, for a subsequent offence, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than two years, or to both; or

• (b) on summary conviction, for a first offence, to a fine of not more than $250,000 or to imprisonment for a term of not more than three months, or to both, and, for a subsequent offence, to a fine of not more than $500,000 or to imprisonment for a term of not more than six months, or to both.

Marginal note:Contravention of section 8 — knowingly

• 57 (1) Every person who knowingly contravenes section 8 is guilty of an offence and liable on conviction on indictment to a fine of not more than $1,000,000 or to imprisonment for a term of not more than five years, or to both.

• Marginal note:Contravention of section 8

  (2) Every person who contravenes section 8 is guilty of an offence and liable

  • (a) on conviction on indictment, for a first offence, to a fine of not more than $500,000 or to imprisonment for a term of not more than six months, or to both, and, for a subsequent offence, to a fine of not more than $1,000,000 or to imprisonment for a term of not more than two years, or to both; or

  • (b) on summary conviction, for a first offence, to a fine of not more than $250,000 or to imprisonment for a term of not more than three months, or to both, and, for a subsequent offence, to a fine of not more than $500,000 or to imprisonment for a term of not more than six months, or to both.

Marginal note:Intentional release

58 Every person who intentionally releases or otherwise abandons a human pathogen or toxin in contravention of this Act or the regulations and, as a result, creates a risk to the health or safety of the public is guilty of an indictable offence and liable to imprisonment for a term of not more than 10 years.

Marginal note:Defence

59 No person who establishes that they exercised all due diligence to prevent the commission of an offence under this Act may be convicted of that offence, except for an offence under

• (a) section 53, with respect to a contravention of subsection 7(1), section 17 and subsection 41(6);

• (b) section 55;

• (c) section 56, with respect to a contravention of subsection 7(1);

• (d) subsection 57(1); and

• (e) section 58.

Marginal note:Place of trial

60 A prosecution for an offence under this Act may be instituted, heard and determined in the place where

• (a) the offence was committed or the subject matter of the prosecution arose;

• (b) the accused was apprehended; or

• (c) the accused happens to be or is carrying on business.

Marginal note:Continuing offences

61 If an offence under this Act is committed or continued on more than one day, the person who committed the offence is liable to be convicted for a separate offence for each day on which it is committed or continued.

Marginal note:Time limit

• 62 (1) Summary conviction proceedings for an offence under this Act may be instituted no later than two years after the day on which the subject matter of the proceedings becomes known to the Minister.

• Marginal note:Minister’s certificate

  (2) A document that appears to be issued by the Minister, certifying the day on which the subject matter of the proceedings became known to the Minister, is admissible in evidence without proof of the signature or official character of the person appearing to have signed it. In the absence of evidence to the contrary, it is proof of the matters asserted in it.

Marginal note:Directors, officers, etc.

63 If a person other than an individual commits an offence under this Act, any of the person’s directors, officers, agents or mandataries who directed, authorized, assented to, acquiesced in or participated in the commission of the offence is a party to and guilty of the offence and is liable on conviction to the punishment provided for the offence, whether or not the person has been prosecuted or convicted.

Marginal note:Offences by employees, agents or mandataries

64 In a prosecution for an offence under this Act, it is sufficient proof of the offence to establish that it was committed by the accused’s employee acting within the scope of their employment, or the accused’s agent or mandatary acting within the scope of their authority, whether or not the employee, agent or mandatary is identified or prosecuted for the offence, unless the accused establishes that

• (a) the offence was committed without the accused’s knowledge or consent; and

• (b) the accused exercised all due diligence to prevent its commission.

Debts

Marginal note:Debts due to Her Majesty

65 The following constitute debts due to Her Majesty in right of Canada and may be recovered as such in any court of competent jurisdiction:

• (a) an amount that a person is directed to pay under an order made by a court under this Act;

• (b) the costs incurred in the seizure, storage, transfer, preservation or disposition under this Act of any human pathogen, toxin or other thing; and

• (c) the costs incurred in the carrying out of a measure under subsection 43(6).

Regulatory Powers

Marginal note:Regulations

• 66 (1) The Governor in Council may make regulations in relation to human pathogens and toxins, including regulations

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

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

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

    • (iii) the safety and security of controlled activities;

  • (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 the conditions 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, and

    • (iv) biological safety cabinets;

  • (d) respecting access 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 to which section 33 applies;

  • (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 and functions of biological safety officers;

  • (j) respecting the establishment, content and maintenance of inventories of human pathogens and toxins, as well as the submission 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 communication 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 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 or safety of the public;

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

  • (p) prescribing any measure that the Governor in Council may consider necessary for the administration or enforcement of this Act.

• 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.

66.1 [Repealed, 2019, c. 29, s. 221]

66.2 [Repealed, 2019, c. 29, s. 221]

Marginal note:Interim orders

• 67 (1) The Minister may make an interim order containing any provision that may be contained in a regulation made under section 66 if the Minister is of the opinion that prompt measures are required to address a serious and imminent danger to the health or safety of the public.

• Marginal note:Duration

  (2) The interim order has effect from the day on which it is made but ceases to have effect on the earliest of

  • (a) 14 days after the day on which it is made, unless it is approved by the Governor in Council,

  • (b) the day on which it is repealed,

  • (c) the day on which a regulation made under section 66 that has the same effect as the interim order comes into force, and

  • (d) one year after the day on which it is made or any shorter period that it specifies.

• Marginal note:Exemption from Statutory Instruments Act

  (3) An interim order is exempt from the application of sections 3 and 9 of the Statutory Instruments Act.

• Marginal note:Deeming

  (4) For the purpose of any provision of this Act other than this section, any reference to regulations made under this Act is deemed to include interim orders, and a reference to a regulation made under a specified provision of this Act is deemed to include a reference to the portion of an interim order containing any provision that may be contained in a regulation made under the specified provision.

• Marginal note:Tabling of order

  (5) A copy of each interim order shall be tabled in each House of Parliament within 15 days after the day on which it is made.

• Marginal note:House not sitting

  (6) In order to comply with subsection (5), the interim order may be sent to the Clerk of the House if the House is not sitting.

Marginal note:Externally produced documents

• 68 (1) A regulation may incorporate by reference documents that are produced by a person or body other than the Minister, including

  • (a) an organization established for the purpose of writing standards, including an organization accredited by the Standards Council of Canada;

  • (b) an industrial or trade organization; or

  • (c) a government.

• Marginal note:Reproduced or translated documents

  (2) A regulation may incorporate by reference documents that the Minister reproduces or translates from documents that are produced by a person or body other than the Minister

  • (a) with any adaptations of form or reference that would facilitate the incorporation of those documents into the regulation; or

  • (b) in a form that sets out only those parts that apply for the purposes of the regulation.

• Marginal note:Jointly produced documents

  (3) A regulation may incorporate by reference documents that the Minister produces jointly with another government for the purpose of harmonizing the regulation with other laws.

• Marginal note:Internally produced standards

  (4) A regulation may incorporate by reference technical or explanatory documents that the Minister produces, including

  • (a) specifications, classifications, illustrations, graphs or other information of a technical nature; and

  • (b) test methods, procedures, operational standards, laboratory safety standards or performance standards of a technical nature.

• Marginal note:Ambulatory incorporation by reference

  (5) A document may be incorporated by reference as amended from time to time.

• Marginal note:Incorporated document not a regulation

  (6) A document that is incorporated by reference in a regulation is not a regulation for the purposes of the Statutory Instruments Act.

• Marginal note:Interpretation

  (7) Subsections (1) to (5) do not limit any authority to make regulations incorporating documents by reference that exists apart from those subsections.