Budget 2025 Implementation Act, No. 1 (S.C. 2026, c. 3)
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Assented to 2026-03-26
PART 5Various Measures (continued)
DIVISION 252009, c. 24Human Pathogens and Toxins Act (continued)
Amendments to the Act (continued)
436 (1) The portion of section 59 of the Act before paragraph (a) is replaced by the following:
Marginal note:Defence
59 No person who establishes that they exercised all due diligence to prevent the contravention of this Act or the regulations may be convicted of that offence, except for an offence under
(2) Paragraph 59(c) of the Act is repealed.
(3) Section 59 of the Act is amended by adding the following after paragraph (b):
(c) section 56;
437 Section 61 of the Act is replaced by the following:
Marginal note:Continuing offences
61 If an offence under this Act or the regulations 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.
438 Subsection 62(1) of the Act is replaced by the following:
Marginal note:Time limit
62 (1) Summary conviction proceedings for an offence under this Act or the regulations may be instituted no later than two years after the day on which the subject matter of the proceedings becomes known to the Minister.
439 Section 63 of the Act is replaced by the following:
Marginal note:Directors, officers and agents or mandataries
63 If a person other than an individual commits an offence under this Act or the regulations, any of the person’s directors, officers or 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.
440 The portion of section 64 of the Act before paragraph (a) is replaced by the following:
Marginal note:Offences by employees or agents or mandataries
64 In a prosecution for an offence under this Act or the regulations, 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 or agent or mandatary is identified or prosecuted for the offence, unless the accused establishes that
441 (1) The portion of section 65 of the English version of the Act before paragraph (a) is replaced by the following:
Marginal note:Debts due to His Majesty
65 The following constitute debts due to His Majesty in right of Canada and may be recovered as such in any court of competent jurisdiction:
(2) Section 65 of the Act is amended by striking out “and” at the end of paragraph (b) and adding the following after paragraph (c):
(d) any administrative monetary penalty required to be paid under this Act;
(e) any amount that is required to be paid under a compliance agreement entered into under subsection 52.3(1);
(f) any amount set out in a notice referred to in paragraph 52.3(4)(a); and
(g) the amount of any reasonable expenses incurred in attempting to recover an amount referred to in paragraph (d), (e) or (f).
442 (1) The portion of subsection 66(1) of the Act before paragraph (c) is replaced by the following:
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;
(2) Paragraph 66(1)(c) of the Act is amended by striking out “and” at the end of subparagraph (iii), by adding “and” at the end of subpargraph (iv) and by adding the following after subparagraph (iv):
(v) security requirements in relation to information technology;
(3) The portion of paragraph 66(1)(d) of the Act before subparagraph (i) is replaced by the following:
(d) respecting access, including remote access by a means of telecommunication, to facilities in which controlled activities are authorized, including
(4) Subsection 66(1) of the Act is amended by adding the following after paragraph (e):
(e.1) respecting incidents referred to in section 14.1;
(5) Paragraph 66(1)(f) of the Act is replaced by the following:
(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;
(6) Paragraph 66(1)(f) of the Act is replaced by the following:
(f) specifying the human pathogen and toxins for the purposes of subparagraphs 7(2)(c)(i) and (iii) and (d)(i) and (iii), section 14.1, subsections 18(2.1) and (6.1) and sections 33 and 33.1;
(7) The portion of paragraph 66(1)(g) of the Act before subparagraph (i) is replaced by the following:
(g) respecting security clearances for the purposes of section 33 and regulations made under paragraph (g.1), including
(8) Subsection 66(1) of the Act is amended by adding the following after paragraph (g):
(g.1) respecting, for the purposes of section 33.1, the conditions to be met, which could include requirements for a security clearance, to
(i) enter a facility in which controlled activities are authorized in relation to human pathogens or toxins that are referred to in paragraph 33.1(1)(a),
(ii) remotely access a facility by a means of telecommunication, or
(iii) access sensitive information referred to in paragraph 33.1(1)(c);
(g.2) respecting the management of any sensitive information;
(9) Paragraph 66(1)(h) of the Act is repealed.
(10) Paragraph 66(1)(i) of English version of the Act is replaced by the following:
(i) respecting the qualifications, powers, duties and functions of biological safety officers;
(11) Paragraph 66(1)(j) of the Act is replaced by the following:
(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;
(12) Subsection 66(1) of the Act is amended by adding the following after paragraph (i.1):
(i.2) respecting sensitive information for the purpose of section 56;
(13) Paragraph 66(1)(l) of the English version of the Act is replaced by the following:
(l) respecting the provision of information to the Minister that is necessary for the administration of this Act and the regulations;
(14) Subsection 66(1) of the Act is amended by adding the following after paragraph (l):
(l.1) respecting information that is to be provided to the Minister under subsection 18(2.1) or (6.1);
(15) Paragraph 66(1)(n) of the Act is replaced by the following:
(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
(16) Paragraph 66(1)(o) of the French version of the Act is replaced by the following:
o) prévoir toute autre mesure d’ordre réglementaire prévue par la présente loi.
(17) Paragraph 66(1)(p) of the Act is repealed.
443 (1) Subsection 67(1) of the Act is replaced by the following:
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 or imminent danger to the health, safety or security of the public.
(2) Paragraph 67(2)(a) of the Act is replaced by the following:
(a) 90 days after the day on which it is made, unless it is approved by the Governor in Council,
(3) Subsection 67(4) of the French version of the Act is replaced by the following:
Marginal note:Présomption
(4) Pour l’application des dispositions de la présente loi — exception faite du présent article —, la mention des règlements pris en vertu de la présente loi vaut mention des arrêtés d’urgence; en cas de renvoi à la disposition habilitante, elle vaut mention du passage des arrêtés d’urgence comportant les mêmes dispositions qu’un règlement pris en vertu de cette disposition.
444 Sections 68 and 69 of the Act are replaced by the following:
Marginal note:Incorporation by reference — limitation removed
68 (1) The limitation set out in paragraph 18.1(2)(a) of the Statutory Instruments Act to the effect that a document must be incorporated as it exists on a particular date does not apply to any power to make regulations under this Act.
Marginal note:Jointly produced documents
(2) A regulation may incorporate by reference documents — as they exist on a particular date or as they are amended from time to time — that the Minister produces jointly with another government for the purpose of harmonizing the regulation with other laws.
445 Schedules 1 to 5 to the Act are replaced by the schedule set out in Schedule 5 to this Act.
SOR/2015-44Consequential Amendments to the Human Pathogens and Toxins Regulations
446 (1) Paragraph 2(1)(c) of the English version of the Human Pathogens and Toxins Regulations is replaced by the following:
(c) any other factor that is relevant to the protection of the health, safety or security of the public.
(2) Subsection 2(3) of the Regulations is replaced by the following:
Marginal note:Renewal
(3) The Minister may renew a licence on application of the licence holder, for further periods set out in subsection (2), if the requirements in subsections 18(1) to (1.2) of the Act are met.
447 (1) The portion of paragraph 4(1)(f) before subparagraph (i) of the Regulations is replaced by the following:
(f) a person who discovers during the conduct of a controlled activity that they are inadvertently in possession of a human pathogen or toxin that is not listed in the schedule to the Act in respect of which that controlled activity is not authorized by the licence must take all of the following steps:
(2) Paragraph 4(2)(c) of the English version of the Regulations is replaced by the following:
(c) provide the biological safety officer with any other information that is relevant to preventing any undue risk to the health, safety or security of the public.
448 Section 6 of the Regulations is amended by adding the following after subsection (2):
Marginal note:Notice to the Minister — risk reduction
(3) If a human pathogen for which controlled activities are authorized by a licence is modified to the extent that it poses a lower risk to the health of individuals or to public health, the licence holder must, without delay, notify the Minister.
449 (1) The portion of subsection 10(1) of the Regulations before paragraph (a) is replaced by the following:
Marginal note:Registry and List
10 (1) The following human pathogens and toxins are prescribed for the purposes of the Act:
(2) Paragraph 10(1)(b) of the Regulations is replaced by the following:
(b) toxins that
(i) are on that List and listed in the registry, and
(ii) are present in a part of a facility in a quantity that is equal to or greater than the minimum quantity at which, in the opinion of the Minister, they pose a moderate to high risk to the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon.
(3) Subsection 10(2) of the Regulations and the table in section 10 are repealed.
450 (1) The portion of section 14 of the English version of the Regulations before paragraph (a) is replaced by the following:
14 The Minister must issue a security clearance if the Minister determines that the applicant does not pose an undue risk to the health, safety or security of the public after considering the information obtained under sections 12 and 13 and taking the following factors into account:
(2) Subparagraph 14(b)(iii) of the Regulations is replaced by the following:
(iii) is or has been a member of a terrorist group or is or has been involved in — or contributes or has contributed to — the activities of such a group,
(3) Paragraph 14(c) of the English version of the Regulations is replaced by the following:
(c) whether there are reasonable grounds to suspect that the applicant is in a position in which there is a risk that they could be induced to commit an act or to assist or abet any person to commit an act that might constitute an undue risk to the health, safety or security of the public;
451 Subsection 21(1) of the English version of the Regulations is replaced by the following:
(1) The Minister must revoke a security clearance if the Minister determines that the holder of the security clearance poses an undue risk to the health, safety or security of the public after considering any of the information described in paragraphs 20(a) to (c).
452 Section 26 of the Regulations is repealed.
Transitional Provisions
Marginal note:Words and expressions
453 (1) The words and expressions used in this section and sections 454 and 455 have the same meaning as in the Human Pathogens and Toxins Act.
Marginal note:Duties
(2) On the day on which section 406 comes into force, any person who, under paragraph 7(2)(c) or (d) of the Human Pathogens or Toxins Act, conducts controlled activities that are not authorized by their licence, must, within 90 days after that day, either apply to the Minister to vary their licence to authorize those activities or stop conducting those activities.
Marginal note:No contravention
(3) A person referred to in subsection (2) does not contravene subsection 7(1) of the Human Pathogens or Toxins Act if they comply with subsection (2).
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