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.
Return to footnote aS.C. 2009, c. 24
1 The following definitions apply in these Regulations.
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)
Marginal note:Period during which licence in effect — factors
2 (1) When determining the period during which a licence is in effect, the Minister must take the following factors into consideration:
(a) the history of the applicant’s compliance, during the previous 10 years, with the provisions of the Act and the regulations, the Department of Health Act, the Human Pathogens Importation Regulations, the Health of Animals Act and the Health of Animals Regulations;
(b) the risks associated with the controlled activities authorized by the licence; and
(c) any other factor that is relevant to the protection of the health or safety of the public.
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.
(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
3 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
4 (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
5 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
6 (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
7 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.
Biological Safety Officers
8 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.
9 (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
10 (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.
Column 1 Column 2 Toxin Quantity (mg)
Toxine du choléra
Clostridium botulinum C2 and C3 toxins
Toxines C2 et C3 de Clostridium botulinum
Clostridium perfringens Epsilon toxin
Toxine Epsilon de Clostridium perfringens
Shiga-like toxin (verotoxin)
Toxine Shiga-like (vérotoxine)
Staphylococcal enterotoxins, Type B
Entérotoxine de staphylocoques, type B
Staphylococcal enterotoxins, types other than Type B
Entérotoxine de staphylocoques, types autres que le B
Staphylococcus aureus Toxic shock syndrome toxin
Toxine du syndrome du choc toxique de Staphylococcus aureus
11 (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.
12 (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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