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.
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).
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.
(2) A regulation may establish classes of persons, facilities, activities, human pathogens and toxins and distinguish among those classes.
Marginal note:Proposed regulations to be laid before Parliament
66.1 (1) Before a regulation is made under section 66, the Minister shall lay the proposed regulation before each House of Parliament.
Marginal note:Report by committee
(2) A proposed regulation that is laid before Parliament shall be referred to the appropriate committee of each House, as determined by the rules of that House, and the committee may review the proposed regulation and report its findings to that House.
Marginal note:Standing Committee on Health
(2.1) The committee of the House of Commons referred to in subsection (2) shall be the Standing Committee on Health or, in the event that there is not a Standing Committee on Health, the appropriate committee of the House.
Marginal note:Making of regulations
(3) A regulation may not be made before the earliest of
(a) 30 sitting days after the proposed regulation is laid before Parliament,
(b) 160 calendar days after the proposed regulation is laid before Parliament, and
(c) the day after each appropriate committee has reported its findings with respect to the proposed regulation.
(4) The Minister shall take into account any report of the committee of either House. If a regulation does not incorporate a recommendation of the committee of either House, the Minister shall lay before that House a statement of the reasons for not incorporating it.
(5) A proposed regulation that has been laid before Parliament need not again be so laid prior to the making of the regulation, whether it has been altered or not.
66.2 (1) A regulation may be made without being laid before either House of Parliament if the Minister is of the opinion that
(a) the changes made by the regulation to an existing regulation are so immaterial or insubstantial that section 66.1 should not apply in the circumstances; or
(b) the regulation must be made immediately in order to protect the health or safety of any person.
Marginal note:Notice of opinion
(2) If a regulation is made without being laid before Parliament, the Minister shall lay before each House of Parliament a statement of the Minister’s reasons.
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.
(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.
(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.
(7) Subsections (1) to (5) do not limit any authority to make regulations incorporating documents by reference that exists apart from those subsections.
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