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

Regulations are current to 2022-08-08 and last amended on 2015-12-01. Previous Versions

Access to Facilities (continued)

Security Clearances (continued)

Marginal note:Record checks

  •  (1) On receipt of a completed application, the Minister must conduct the following record checks for the purpose of making a determination of risk under section 14:

    • (a) a criminal record check;

    • (b) a check of the relevant files of law enforcement agencies, including intelligence gathered for law enforcement purposes;

    • (c) a Canadian Security Intelligence Service security assessment; and

    • (d) a credit check.

  • Marginal note:Additional information

    (2) The Minister may, in writing, request any further relevant information from the applicant for the purpose of making the determination of risk under section 14.

Marginal note:Issuance — risk assessment

 The Minister must issue a security clearance if the Minister determines that the applicant does not pose an undue risk to the health or safety of the public after considering the information obtained under sections 12 and 13 and taking the following factors into account:

  • (a) the relevance of the information, including the circumstances of the underlying events or convictions, their seriousness, number and frequency, the date of the last event or conviction and any sentence or other disposition;

  • (b) whether it is known or there are reasonable grounds to suspect that the applicant

    • (i) is or has been involved in — or contributes or has contributed to — activities that are directed toward or in support of the use of human pathogens or toxins to commit either criminal offences or acts of violence against persons or property,

    • (ii) is or has been involved in — or contributes or has contributed to — activities that constitute threats to the security of Canada within the meaning of the Canadian Security Intelligence Service Act,

    • (iii) is or has been a member of a terrorist group as defined in subsection 83.01(1) of the Criminal Code or is or has been involved in — or contributes or has contributed to — the activities of such a group,

    • (iv) is or has been a member of a criminal organization as defined in subsection 467.1(1) of that Act or participates or has participated in — or contributes or has contributed to — activities of such an organization as described in subsection 467.11(1) of that Act,

    • (v) is or has been a member of an organization that is known to be involved in or to contribute to — or in respect of which there are reasonable grounds to suspect involvement in or contribution to — activities that are directed toward or in support of either the use of human pathogens or toxins to commit criminal offences or the threat of or the use of acts of violence against persons or property, or

    • (vi) is or has been associated with an individual who is known to be involved in or to contribute to — or in respect of whom there are reasonable grounds to suspect involvement in or contribution to — activities referred to in subparagraph (i) or (ii), or who is a member of a group or organization referred to in any of subparagraphs (iii) to (v);

  • (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 or safety of the public;

  • (d) whether the applicant has previously had a security clearance suspended or revoked;

  • (e) whether the applicant has provided false or misleading information in or in connection with their application;

  • (f) whether any foreign jurisdiction has refused to issue the equivalent of a security clearance to the applicant — or has suspended or revoked one — and the reason for the refusal, suspension or revocation; and

  • (g) any other relevant information to enable the Minister to assess the risk.

Marginal note:Postponement — outstanding criminal charges

 If a criminal charge is outstanding against the applicant for a security clearance that would, if they were found guilty of it, be considered by the Minister under paragraph 14(a), the Minister may postpone processing their application until the charge is disposed of by the courts and must notify the applicant in writing of the postponement.

Marginal note:Validity period

 The Minister must establish the validity period of a security clearance in accordance with the level of risk posed by the applicant as determined under section 14. The validity period must not exceed five years.

Marginal note:Notice of issuance or refusal

 When the Minister issues or refuses to issue a security clearance, the Minister must notify in writing every licence holder or applicant for a licence who has signed a statement described in paragraph 12(2)(m) with respect to the application for that security clearance.

Marginal note:Additional facility or part of facility

 The holder of a security clearance who wishes to access a part of a facility described in section 33 of the Act not included in their application for the security clearance must provide the Minister with a statement described in paragraph 12(2)(m) in respect of each new facility or part.

Marginal note:Notice in writing

 The holder of a security clearance must notify the Minister in writing without delay if they are found guilty of a criminal offence after the issuance of their security clearance.

Marginal note:Suspension

 The Minister may suspend a security clearance on receipt of any of the following information:

  • (a) new information described in any of sections 12 to 14 that was not available for consideration when the security clearance was issued;

  • (b) a notice from the holder of the security clearance under section 19; or

  • (c) the decision of a licence holder, under section 32 of the Act, to prohibit the holder of the security clearance from having access to the facility to which the licence applies, and their reasons for the decision under section 7.

Marginal note:Revocation

  •  (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 or safety of the public after considering any of the information described in paragraphs 20(a) to (c).

  • Marginal note:Notice to licence holders

    (2) On the revocation, the Minister must notify in writing every licence holder who has signed a statement described in paragraph 12(2)(m) with respect to that security clearance.

Marginal note:Reasons in writing

 A written notice required under subsection 34(1) or 35(5) of the Act must contain the Minister’s reasons for the decision.

Accompaniment and Supervision

Marginal note:One person at a time

  •  (1) For the purpose of section 33 of the Act, a person who holds a security clearance may at any time accompany and supervise only one person who does not hold a security clearance.

  • Marginal note:Continuous supervision

    (2) A person who accompanies and supervises another person must at all times be in the same room as them and must monitor their activities at all times.

Marginal note:No access in certain circumstances

 For the purpose of section 33 of the Act, a person must not enter a part of a facility even under accompaniment and supervision in either of the following circumstances:

  • (a) their security clearance is suspended, or

  • (b) they have previously been refused a security clearance or their security clearance has previously been revoked, and a new security clearance has not been issued to them since the refusal or revocation.

Marginal note:Records

 The licence holder must keep a record of the full name of every person who enters a facility under accompaniment and supervision, together with the date on which they entered and the full name of the person who accompanied and supervised them.

Exemptions

Marginal note:Exemption from Risk Group 2 — risk reduction

  •  (1) A human pathogen that is listed in Schedule 2 to the Act is exempt from the application of the definition Risk Group 2 in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

  • Marginal note:Exemption from Risk Group 3 — risk reduction

    (2) A human pathogen that is listed in Schedule 3 to the Act is exempt from the application of the definition Risk Group 3 in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

  • Marginal note:Exemption from Risk Group 4 — risk reduction

    (3) A human pathogen that is listed in Schedule 4 to the Act is exempt from the application of the definition Risk Group 4 in subsection 3(1) of the Act if it has been modified to the extent that it no longer meets the risk profile described in that definition.

  • Marginal note:Notice to Minister

    (4) In the circumstances described in subsections (1) to (3), the licence holder must notify the Minister without delay after such a modification.

Marginal note:Exemption from licence requirement — laboratories

  •  (1) A person who carries out laboratory analyses or diagnostic testing with a human pathogen that is neither a prion nor a prescribed human pathogen is exempt from the application of section 7 of the Act on condition that

    • (a) they do not cultivate or otherwise produce a human pathogen; or

    • (b) if there is any production, it is done using a sealed container that prevents the release of the human pathogen and that is decontaminated before its disposal or reuse.

  • Marginal note:Exemption from licence requirement — veterinary practices

    (2) A veterinarian who is registered under the laws of a province — and any persons under their supervision — who carry out laboratory analyses or diagnostic testing with a human pathogen that falls into Risk Group 2 are exempt from the application of section 7 of the Act on condition that any controlled activities that they conduct in respect of that pathogen are conducted in the course of providing care to animals in a clinical practice in that province.

Marginal note:Exemption — section 33 of Act

 A person is exempt from the application of section 33 of the Act with respect to a part of a facility on either of the following conditions:

  • (a) there is no prescribed human pathogen or toxin present in that part of the facility, or

  • (b) any prescribed human pathogen or toxin that is present is locked up and inaccessible to that person.

Documents

Marginal note:Document retention

  •  (1) Documents that are required under the Act to be prepared must be maintained for five years after the day on which they are prepared and must be provided to the Minister on request.

  • Marginal note:Exception — incidents

    (2) Despite subsection (1), the retention period is 10 years for documents that contain information that relates to the following incidents:

    • (a) an incident that is described in subsection 12(1) or (2), or section 13 or 14, of the Act; and

    • (b) any incident that results in a failure of or compromise to biocontainment.

Marginal note:Receipt of documents

 Any document that is sent by the Minister under the Act is considered to have been received on the earlier of the following days:

  • (a) the day that is five days after it was sent, and

  • (b) the day on which it is received.

Transitional Provisions

Marginal note:Continuation of controlled activities

  •  (1) A person who, on the day on which these Regulations come into force, conducts controlled activities in respect of a human pathogen or toxin is exempt from the application of section 7 of the Act if they submit an application for a licence under subsection 18(2) of the Act within 90 days after that day.

  • Marginal note:Duration

    (2) Subsection (1) applies until the Minister issues or refuses to issue the licence under subsection 18(1) or (3) of the Act, respectively.

Marginal note:Continuation of controlled activities — prescribed human pathogens and toxins

  •  (1) An individual who, on the day on which these Regulations come into force, conducts controlled activities in respect of a prescribed human pathogen or toxin is exempt from the application of section 33 of the Act if they submit an application for a security clearance under section 12 within 90 days after that day.

  • Marginal note:Duration

    (2) Subsection (1) applies until the Minister issues or refuses to issue the security clearance under subsection 34(1) of the Act.

Coming into Force

Marginal note:December 1, 2015

 These Regulations come into force on December 1, 2015.

 
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