Budget 2025 Implementation Act, No. 1 (S.C. 2026, c. 3)

• 407 (1) The portion of paragraph 10(1)(a) of the Act before subparagraph (ii) is replaced by the following:

  • (a) add a substance to Part 1 of the schedule if the Governor in Council is of the opinion that

    • (i) it is produced by, or derived from, a micro-organism and poses a moderate to high risk to

      • (A) the health of individuals, or

      • (B) the health, safety or security of the public due to a reasonable risk of intentional use as a biological weapon, and

• (2) The portion of paragraph 10(1)(b) of the Act before subparagraph (i) is replaced by the following:

  • (b) add a micro-organism, nucleic acid or protein to Part 2 of the schedule if the Governor in Council is of the opinion that

• (3) Subsection 10(1) of the Act is amended by adding “or” at the end of paragraph (a), by striking out “or” at the end of paragraph (b) and by repealing (c).

• (4) Subsection 10(2) of the Act is replaced by the following:

  • Marginal note:Deletion of items

    (2) The Governor in Council may, by regulation, on the Minister’s recommendation, delete a substance, micro-organism, nucleic acid or protein from the schedule if the Governor in Council is of the opinion that it is in the public interest to allow one or more of the activities referred to in section 7 to be authorized in relation to that substance, micro-organism, nucleic acid or protein.

408 The heading before section 11 of the Act is replaced by the following:

• 409 (1) The portion of subsection 11(1) of the Act before paragraph (a) is replaced by the following:

  Marginal note:Prohibited possession — update

  • 11 (1) Within 30 days after the date that an update to the registry under subsection 9(1) is publicly accessible, every person who, as a result of the update to the registry, no longer has lawful possession of a human pathogen or toxin must

• (2) Subsection 11(2) of the English version of the Act is replaced by the following:

  • Marginal note:Prohibited possession — schedule

    (2) Within 14 days after the date of publication of a regulation made under subsection 10(1), every person who, as a result of the regulation, no longer has lawful possession of a human pathogen or toxin must dispose of it in accordance with the regulations, if any.

• (3) Subsection 11(3) of the Act is replaced by the following:

  • Marginal note:No contravention

    (3) No person contravenes subsection 7(1) or section 8 by reason only that they possess a human pathogen or toxin in the circumstances described in subsection (1) or (2) if they transfer or dispose of it or obtain a licence or a variation of their existing licence authorizing possession of it, in accordance with subsection (1) or (2).

  • Marginal note:Defence

    (4) If a human pathogen or toxin is listed in the registry, then no person may be convicted of an offence — in relation to that human pathogen or toxin — for the contravention of this Act or the regulations unless it is proved that, at the time of the alleged contravention,

    • (a) the registry with the human pathogen or toxin listed in it was reasonably accessible to the person;

    • (b) the human pathogen or toxin was listed in the registry; and

    • (c) the registry indicated, in relation to the human pathogen or toxin,

      • (i) the risk group into which the human pathogen falls,

      • (ii) if the toxin poses 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, the references referred to in paragraph 9(2)(a), or

      • (iii) the minimum quantity at which the toxin poses a moderate to high risk to the health of individuals, if any.

• (4) The portion of subsection 11(4) of the Act before paragraph (a) is replaced by the following:

  • Marginal note:Defence

    (4) If a human pathogen or toxin is listed in the registry, then no person may be convicted of an offence or subjected to an administrative monetary penalty — in relation to that human pathogen or toxin — for the contravention of any provision of this Act or the regulations unless it is proved that, at the time of the alleged contravention,

• 410 (1) Subsection 12(1) of the Act is replaced by the following:

  Marginal note:Inadvertent release

  • 12 (1) If a licence holder has reasonable grounds to suspect that a human pathogen or toxin has been released inadvertently from a facility in the course of a controlled activity authorized by the licence, the licence holder must, without delay, inform the Minister of the release and provide the Minister with the information referred to in subsection (3) that is under the licence holder’s control.

• (2) Paragraph 12(2)(b) of the Act is replaced by the following:

  • (b) dispose of the inadvertently produced human pathogen or toxin in accordance with the regulations, if any, or, if it is not listed in the schedule, transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.

411 The portion of section 13 of the Act before paragraph (a) is replaced by the following:

412 Sections 14 to 16 of the Act are replaced by the following:

413 Section 15 of the Act is replaced by the following:

414 Section 16 of the Act is replaced by the following:

• 415 (1) Subsection 18(1) of the English version of the Act is replaced by the following:

  Marginal note:Issuance

  • 18 (1) The Minister may, in accordance with the regulations, if any, issue a licence that authorizes any controlled activity in any facility if the Minister is of the opinion that the conduct of the controlled activity in the facility poses no undue risk to the health, safety or security of the public.

• (2) Section 18 of the Act is amended by adding the following after subsection (1):

  • Marginal note:Conditions

    (1.1) Despite subsection (1), the Minister may issue a licence only if,

    • (a) in the case that the applicant is an individual, the applicant and the biological safety officer designated for the licence are ordinarily resident in Canada; or

    • (b) in the case that the applicant is an organization, the applicant is incorporated, formed or otherwise organized in Canada and its representative and the biological safety officer designated for the licence are ordinarily resident in Canada.

  • Marginal note:Debts due to His Majesty

    (1.2) In exercising the power conferred by subsection (1), the Minister may consider whether an applicant or any organization with which an applicant is or was affiliated owes an amount referred to in section 65.

• (3) Section 18 of the Act is amended by adding the following after subsection (2):

  • Marginal note:Information

    (2.1) An application for a licence to authorize controlled activities in relation to human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins that are prescribed by regulation must include the information prescribed by regulation and make reference, in accordance with the regulations, to the following:

    • (a) any contribution or other funding that originates from outside Canada that the applicant received or expects to receive in relation to their activities;

    • (b) if the applicant is an organization, any person or foreign entity that has or is seeking to have any direct or indirect ownership or influence over the organization that would result in control in fact of the organization; and

    • (c) if the applicant is an individual, any person or foreign entity that has or is seeking to have any direct or indirect influence over any activities of the applicant that are governed by this Act or the regulations.

• (4) Subsection 18(3) of the Act is replaced by the following:

  • Marginal note:Refusal to issue licence

    (3) If the Minister refuses to issue a licence, the Minister must notify the applicant in writing of the reasons for the refusal.

• (5) Subsection 18(4) of the English version of the Act is replaced by the following:

  • Marginal note:Conditions

    (4) A licence authorizes the controlled activities that are specified in it and is subject to any conditions that the Minister considers appropriate to protect the health, safety and security of the public.

• (6) Section 18 of the Act is amended by adding the following after subsection (4):

  • Marginal note:Conditions — transportation

    (4.1) If the Minister considers it appropriate to impose licence conditions for the conduct of controlled activities to which the Transportation of Dangerous Goods Act, 1992 applies, they must consult with the Minister of Transport and may consult with any other person the Minister considers appropriate.

  • Marginal note:Failure to consult

    (4.2) The failure of the Minister to comply with the requirement to consult under subsection (4.1) does not exempt the licence holder and all persons conducting the controlled activities authorized by the licence from the obligation to comply with the licence conditions.

• (7) Paragraph 18(5)(a) of the Act is replaced by the following:

  • (a) the licence holder’s name and, if applicable, the name of the individual who is designated as a representative for the licence holder;

  • (a.1) the biological safety officer’s name;

• (8) Subsection 18(5) of the Act is amended by adding the following after paragraph (d):

  • (d.1) a description of each part of the facility that is prescribed by the regulations made for the purposes of section 33.1;

• (9) Section 18 of the Act is amended by adding the following after subsection (6):

  • Marginal note:Obligation of the licence holder — information

    (6.1) If a licence authorizes controlled activities in relation to human pathogens that fall into Risk Group 3 and are prescribed by regulation, human pathogens that fall into Risk Group 4 or toxins that are prescribed by regulation, the licence holder must provide the Minister with the information prescribed by regulation and inform them, in accordance with the regulations, of the following:

    • (a) any contribution or other funding that originates from outside Canada that the licence holder received or expects to receive in relation to their activities;

    • (b) if the licence holder is an organization, any person or foreign entity that has or is seeking to have any direct or indirect ownership or influence over the organization that would result in control in fact of the organization; and

    • (c) if the licence holder is an individual, any person or foreign entity that has or is seeking to have any direct or indirect influence over any activities of the licence holder that are governed by this Act or the regulations.

416 Section 19 of the Act is replaced by the following: