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Human Pathogens and Toxins Regulations (SOR/2015-44)

Regulations are current to 2019-11-19 and last amended on 2015-12-01. Previous Versions

Human Pathogens and Toxins Regulations

SOR/2015-44

HUMAN PATHOGENS AND TOXINS ACT

Registration 2015-02-20

Human Pathogens and Toxins Regulations

P.C. 2015-203 2015-02-19

Whereas, pursuant to section 66.1 of the Human Pathogens and Toxins ActFootnote a, the Minister of Health has caused a copy of the proposed Human Pathogens and Toxins Regulations to be laid before each House of Parliament, substantially in the annexed form;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 66 of the Human Pathogens and Toxins ActFootnote a, makes the annexed Human Pathogens and Toxins Regulations.

Interpretation

Marginal note:Definitions

 The following definitions apply in these Regulations.

Act

Act means the Human Pathogens and Toxins Act. (Loi)

common-law partner

common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year. (conjoint de fait)

scientific research

scientific research means the following types of systematic investigation or research that are carried out in a field of science or technology by means of controlled activities:

  • (a) basic research, when the controlled activities are conducted for the advancement of scientific knowledge without a specific practical application;

  • (b) applied research, when the controlled activities are conducted for the advancement of scientific knowledge with a specific practical application; and

  • (c) experimental development, when the controlled activities are conducted to achieve scientific or technological advancement for the purpose of creating new — or improving existing — materials, products, processes or devices. (recherche scientifique)

Licences

Marginal note:Period during which licence in effect — factors

  •  (1) When determining the period during which a licence is in effect, the Minister must take the following factors into consideration:

  • Marginal note:Maximum period

    (2) The maximum period during which a licence may be in effect is the following:

    • (a) five years, if the licence authorizes controlled activities in respect of

      • (i) a human pathogen that falls into Risk Group 2,

      • (ii) a prion that falls into Risk Group 3, or

      • (iii) a toxin that is not prescribed under section 10;

    • (b) three years, if the licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 3 — other than a prion — or a toxin that is prescribed under section 10; or

    • (c) one year, if the licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 4.

  • Marginal note:Renewal

    (3) The Minister may renew a licence on application of the licence holder, for further periods set out in subsection (2).

Marginal note:Condition on issuance — risk management plan

 If the applicant for a licence is a person who intends to carry out scientific research, the Minister must, before issuing the licence, determine that the person has developed a plan that sets out administrative measures for managing and controlling biosafety and biosecurity risks during the period in which the licence is in effect.

Marginal note:Conditions of licence

  •  (1) Every licence is subject to the following conditions:

    • (a) the licence holder and any person who is conducting controlled activities authorized by the licence must not obstruct the biological safety officer when the officer is exercising their powers or carrying out their functions;

    • (b) a person who intends to conduct any of the following controlled activities must communicate that intention to the biological safety officer before they make any arrangements to do so:

      • (i) importing or exporting a human pathogen or toxin,

      • (ii) possessing a human pathogen or toxin as a result of receiving from another licence holder or from a person who is conducting controlled activities authorized by another licence, or

      • (iii) transferring a human pathogen or toxin to another licence holder or to a person who is conducting controlled activities authorized by another licence;

    • (c) a person who intends to transfer a human pathogen or toxin must, before the transfer, take reasonable care to be satisfied of the following:

      • (i) that the intended recipient is exempt from the requirement to hold a licence, or

      • (ii) that the intended recipient will conduct controlled activities in relation to that human pathogen or toxin in a facility that is set out in a licence that authorizes those controlled activities with respect to that human pathogen or toxin;

    • (d) a person who intends to export a human pathogen or toxin must, before they export it, take reasonable care to be satisfied that the intended recipient will conduct any activities in respect of the human pathogen or toxin in accordance with any applicable biosafety and biosecurity standards and policies in the foreign jurisdiction;

    • (e) the intended recipient of a human pathogen or toxin must make reasonable efforts to locate it if it is not received within a reasonable time after it was expected to be received, and must inform the biological safety officer of the situation without delay; and

    • (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 Schedule 5 to the Act in respect of which that controlled activity is not authorized by the licence must take all of the following steps:

      • (i) inform the biological safety officer of the inadvertent possession without delay,

      • (ii) ensure that the human pathogen or toxin is handled and stored appropriately while it is in their possession, and

      • (iii) within 30 days, dispose of it or transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.

  • Marginal note:Additional condition — prescribed human pathogens and toxins

    (2) Every licence that authorizes controlled activities in respect of a human pathogen or toxin that is prescribed under section 10 is subject to the further condition that, if the intended recipient of such a human pathogen or toxin does not receive it within 24 hours after the expected date and time, they must take all of the following steps:

    • (a) make reasonable efforts to locate it;

    • (b) inform the biological safety officer without delay that they have not received it; and

    • (c) provide the biological safety officer with any other information that is relevant to preventing any undue risk to the health or safety of the public.

Marginal note:Notification to licence holder and biological safety officer

 A person who is conducting controlled activities authorized by a licence must notify the licence holder and the biological safety officer, in writing, whenever they intend to do any of the following:

  • (a) increase the virulence or pathogenicity of a human pathogen;

  • (b) increase the communicability of a human pathogen;

  • (c) increase the resistance of a human pathogen to preventive or therapeutic treatments; or

  • (d) increase the toxicity of a toxin.

Marginal note:Notice to Minister before making change

  •  (1) A licence holder must — if their licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 3 or Risk Group 4 or in respect of a prescribed toxin — notify the Minister before they make any change to the physical structure of the facility, to any equipment or to the standard operating procedures that could affect biocontainment.

  • Marginal note:Notice to Minister after name change

    (2) A licence holder must notify the Minister, in writing, within a reasonable time after they make any change to their name.

Marginal note:Section 32 of Act

 A licence holder must, when informing the Minister under section 32 of the Act of a decision to prohibit the holder of a security clearance from having access to the facility to which the licence applies, include their reasons for the decision.

 
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