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

Regulations are current to 2019-08-28 and last amended on 2015-12-01. Previous Versions

Biological Safety Officers

Marginal note:Qualifications

 A biological safety officer must have the following qualifications:

  • (a) knowledge of microbiology appropriate to the risks associated with the controlled activities authorized by the licence, attained through a combination of education, training and experience;

  • (b) knowledge of the provisions of the Act and the regulations and any applicable federal or provincial legislation; and

  • (c) knowledge of the applicable biosafety and biosecurity policies, standards and practices appropriate to the risks associated with the controlled activities authorized by the licence.

Marginal note:Functions

  •  (1) A biological safety officer has the following functions:

    • (a) verify the accuracy and completeness of licence applications;

    • (b) communicate with the Minister on behalf of the licence holder;

    • (c) promote and monitor compliance with the provisions of the Act and the regulations, with the licence and with the applicable biosafety and biosecurity standards by, among other things,

      • (i) arranging for and documenting appropriate training related to applicable biosafety and biosecurity policies, standards and practices for all persons who conduct controlled activities authorized by the licence,

      • (ii) informing the Minister, without delay, of all occurrences of inadvertent possession that they are informed of under paragraph 4(1)(f),

      • (iii) informing the Minister, without delay, of every situation that they are informed of under subsection 4(2),

      • (iv) conducting periodic inspections and biosafety audits and reporting the findings to the licence holder, and

      • (v) informing the licence holder in writing of any non-compliance by a person conducting controlled activities authorized by the licence that is not being corrected by that person after they have been made aware of it;

    • (d) assist in the development and maintenance of the licence holder’s biosafety manual and standard operating procedures related to biosafety and biosecurity; and

    • (e) assist with internal investigations of incidents described in subsection 12(1) or (2), or section 13 or 14, of the Act or of any incident that results in a failure of or compromise to biocontainment.

  • Marginal note:Power to require records to be provided

    (2) A biological safety officer may require any person who conducts controlled activities authorized by the licence to provide them with any records that are necessary to assist them in carrying out their functions.

Access to Facilities

Prescribed Human Pathogens and Toxins

Marginal note:Section 33 of Act

  •  (1) The following human pathogens and toxins are prescribed for the purposes of the Act and, more particularly, are specified for the purpose of section 33 of the Act:

    • (a) human pathogens that fall into Risk Group 3 or Risk Group 4 and that are on the common control list entitled List of Human and Animal Pathogens and Toxins for Export Control, published by the Australia Group, as amended from time to time, except for

      • (i) Duvenhage virus, Rabies virus and other members of the Lyssavirus genus,

      • (ii) Vesicular stomatitis virus, and

      • (iii) Lymphocytic choriomeningitis virus; and

    • (b) subject to subsection (2), toxins that are set out in Schedule 1 to the Act and that are on that List.

  • Marginal note:Toxins not prescribed in certain quantities

    (2) A toxin that is set out in column 1 of the table to this section is not a prescribed toxin if it is present in a part of a facility in a quantity that is less than or equal to the quantity set out in column 2.

    TABLE

    Column 1Column 2
    ToxinQuantity (mg)
    • Alpha toxin

      Toxine Alpha

    5
    • Botulinum neurotoxin

      Toxine botulique

    0.5
    • Cholera toxin

      Toxine du choléra

    20
    • Clostridium botulinum C2 and C3 toxins

      Toxines C2 et C3 de Clostridium botulinum

    5
    • Clostridium perfringens Epsilon toxin

      Toxine Epsilon de Clostridium perfringens

    5
    • Hemolysin

      Hemolysine

    10
    • Shiga-like toxin (verotoxin)

      Toxine Shiga-like (vérotoxine)

    1
    • Shigatoxin

      Shigatoxine

    1
    • Staphylococcal enterotoxins, Type B

      Entérotoxine de staphylocoques, type B

    1
    • Staphylococcal enterotoxins, types other than Type B

      Entérotoxine de staphylocoques, types autres que le B

    10
    • Staphylococcus aureus Toxic shock syndrome toxin

      Toxine du syndrome du choc toxique de Staphylococcus aureus

    5

Security Clearances

Marginal note:Eligibility

  •  (1) The Minister may only issue a security clearance to an individual who is 18 years of age or older.

  • Marginal note:Refusal or revocation in past five years

    (2) An individual is not eligible for a security clearance in either of the following circumstances:

    • (a) the Minister has refused to issue a security clearance to them within the past five years, or

    • (b) the Minister has revoked their security clearance within the past five years.

  • Marginal note:False or inaccurate information

    (3) Subsection (2) does not apply if any of the information that formed the basis of the refusal or revocation proves to be false or inaccurate.

Marginal note:Application

  •  (1) An individual who wishes to obtain a security clearance must submit an application to the Minister.

  • Marginal note:Content of application

    (2) The application for a security clearance must be signed and dated by the applicant and must contain all of the following information and documents:

    • (a) the applicant’s full name, all other names used by them and the details of any name changes;

    • (b) their gender, height, weight and eye and hair colour;

    • (c) their date and place of birth and

      • (i) if they were born in Canada, a copy of their birth certificate, or

      • (ii) if they were born outside Canada, the entry point and date of entry into Canada, or the intended entry point and date of entry into Canada, and, in the case of a naturalized Canadian citizen or a permanent resident of Canada, the number of the applicable certificate that was issued under the Citizenship Act or the Immigration and Refugee Protection Act;

    • (d) their address and telephone number, at home and at work, and their email address;

    • (e) the addresses where they have lived during the past five years;

    • (f) the names and addresses of their employers during the past five years and of any post-secondary educational institutions that they attended during that period;

    • (g) their fingerprints, taken by any of the following:

      • (i) a Canadian police force,

      • (ii) a private company that is accredited by the Royal Canadian Mounted Police to submit fingerprints to it for the purpose of a criminal record check, or

      • (iii) a department or agency of the Government of Canada;

    • (h) a copy of each of two pieces of valid government-issued identification, one of which must be photo identification;

    • (i) if they are not a Canadian citizen or a permanent resident of Canada, the following documents:

      • (i) a copy of their curriculum vitae that sets out their professional qualifications and work history,

      • (ii) a valid visa, if applicable, and

      • (iii) the results of a police record check from every jurisdiction where they have lived during the past five years, if that jurisdiction provides police record checks;

    • (j) the dates, destination and purpose of any travel for periods longer than 90 days outside their country of residence, excluding business travel for the Government of Canada, during the five years before the date of their application;

    • (k) if they have a spouse or common-law partner, all of the following information with respect to that spouse or common-law partner:

      • (i) their gender, full name, all other names used by them and the details of any name changes,

      • (ii) their date and place of birth,

      • (iii) if they were born in Canada, a copy of their birth certificate,

      • (iv) if they were born outside Canada, the information described in subparagraph (c)(ii), and

      • (v) their current address, if known;

    • (l) in the case of a former spouse or common-law partner who died or with whom the relationship ended within the past five years, the information described in subparagraphs (k)(i), (ii) and (v) and, if applicable, their date of death; and

    • (m) subject to subsection (4), a statement that certifies that they require the security clearance and the part of the facility for which it is required, signed and dated by both the applicant and either the licence holder or an applicant for a licence for that facility.

  • Marginal note:One statement per facility

    (3) The application must include a statement described in paragraph (2)(m) in respect of each separate facility.

  • Marginal note:Exception — inspectors

    (4) An inspector who is designated under section 40 of the Act need not include the statement described in paragraph (2)(m) in their application.

 
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