SOR/2015-4420152
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HUMAN PATHOGENS AND TOXINS ACTHuman Pathogens and Toxins RegulationsP.C.2015-20320152
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Whereas, pursuant to section 66.1 of the Human Pathogens and Toxins Acta, 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 Acta, makes the annexed Human Pathogens and Toxins Regulations.S.C. 2009, c. 24Interpretation
DefinitionsThe following definitions apply in these Regulations.Act means the Human Pathogens and Toxins Act. (Loi)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 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:basic research, when the controlled activities are conducted for the advancement of scientific knowledge without a specific practical application;applied research, when the controlled activities are conducted for the advancement of scientific knowledge with a specific practical application; andexperimental 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
Period during which licence in effect — factorsWhen determining the period during which a licence is in effect, the Minister must take the following factors into consideration: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;the risks associated with the controlled activities authorized by the licence; andany other factor that is relevant to the protection of the health or safety of the public.Maximum periodThe maximum period during which a licence may be in effect is the following:five years, if the licence authorizes controlled activities in respect ofa human pathogen that falls into Risk Group 2,a prion that falls into Risk Group 3, ora toxin that is not prescribed under section 10;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; orone year, if the licence authorizes controlled activities in respect of a human pathogen that falls into Risk Group 4.RenewalThe Minister may renew a licence on application of the licence holder, for further periods set out in subsection (2).
Condition on issuance — risk management planIf 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.
Conditions of licenceEvery licence is subject to the following conditions: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;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:importing or exporting a human pathogen or toxin,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, ortransferring a human pathogen or toxin to another licence holder or to a person who is conducting controlled activities authorized by another licence;a person who intends to transfer a human pathogen or toxin must, before the transfer, take reasonable care to be satisfied of the following:that the intended recipient is exempt from the requirement to hold a licence, orthat 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;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;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; anda 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:inform the biological safety officer of the inadvertent possession without delay,ensure that the human pathogen or toxin is handled and stored appropriately while it is in their possession, andwithin 30 days, dispose of it or transfer it to a facility where controlled activities in relation to that human pathogen or toxin are authorized.Additional condition — prescribed human pathogens and toxinsEvery 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:make reasonable efforts to locate it;inform the biological safety officer without delay that they have not received it; andprovide the biological safety officer with any other information that is relevant to preventing any undue risk to the health or safety of the public.
Notification to licence holder and biological safety officerA 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:increase the virulence or pathogenicity of a human pathogen;increase the communicability of a human pathogen;increase the resistance of a human pathogen to preventive or therapeutic treatments; orincrease the toxicity of a toxin.
Notice to Minister before making changeA 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.Notice to Minister after name changeA licence holder must notify the Minister, in writing, within a reasonable time after they make any change to their name.
Section 32 of ActA 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
QualificationsA biological safety officer must have the following qualifications: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;knowledge of the provisions of the Act and the regulations and any applicable federal or provincial legislation; andknowledge of the applicable biosafety and biosecurity policies, standards and practices appropriate to the risks associated with the controlled activities authorized by the licence.
FunctionsA biological safety officer has the following functions:verify the accuracy and completeness of licence applications;communicate with the Minister on behalf of the licence holder;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,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,informing the Minister, without delay, of all occurrences of inadvertent possession that they are informed of under paragraph 4(1)(f),informing the Minister, without delay, of every situation that they are informed of under subsection 4(2),conducting periodic inspections and biosafety audits and reporting the findings to the licence holder, andinforming 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;assist in the development and maintenance of the licence holder’s biosafety manual and standard operating procedures related to biosafety and biosecurity; andassist 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.Power to require records to be providedA 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 FacilitiesPrescribed Human Pathogens and Toxins
Section 33 of ActThe 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: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 forDuvenhage virus, Rabies virus and other members of the Lyssavirus genus,Vesicular stomatitis virus, andLymphocytic choriomeningitis virus; andsubject to subsection (2), toxins that are set out in Schedule 1 to the Act and that are on that List.Toxins not prescribed in certain quantitiesA 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.TABLEColumn 1Column 2ToxinQuantity (mg)Alpha toxinToxine Alpha5Botulinum neurotoxinToxine botulique0.5Cholera toxinToxine du choléra20Clostridium botulinum C2 and C3 toxinsToxines C2 et C3 de Clostridium botulinum5Clostridium perfringens Epsilon toxinToxine Epsilon de Clostridium perfringens5HemolysinHemolysine10Shiga-like toxin (verotoxin)Toxine Shiga-like (vérotoxine)1ShigatoxinShigatoxine1Staphylococcal enterotoxins, Type BEntérotoxine de staphylocoques, type B1Staphylococcal enterotoxins, types other than Type BEntérotoxine de staphylocoques, types autres que le B10Staphylococcus aureus Toxic shock syndrome toxinToxine du syndrome du choc toxique de Staphylococcus aureus5
Security Clearances
EligibilityThe Minister may only issue a security clearance to an individual who is 18 years of age or older.Refusal or revocation in past five yearsAn individual is not eligible for a security clearance in either of the following circumstances:the Minister has refused to issue a security clearance to them within the past five years, orthe Minister has revoked their security clearance within the past five years.False or inaccurate informationSubsection (2) does not apply if any of the information that formed the basis of the refusal or revocation proves to be false or inaccurate.
ApplicationAn individual who wishes to obtain a security clearance must submit an application to the Minister.Content of applicationThe application for a security clearance must be signed and dated by the applicant and must contain all of the following information and documents:the applicant’s full name, all other names used by them and the details of any name changes;their gender, height, weight and eye and hair colour;their date and place of birth andif they were born in Canada, a copy of their birth certificate, orif 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;their address and telephone number, at home and at work, and their email address;the addresses where they have lived during the past five years;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;their fingerprints, taken by any of the following:a Canadian police force,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, ora department or agency of the Government of Canada;a copy of each of two pieces of valid government-issued identification, one of which must be photo identification;if they are not a Canadian citizen or a permanent resident of Canada, the following documents:a copy of their curriculum vitae that sets out their professional qualifications and work history,a valid visa, if applicable, andthe 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;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;if they have a spouse or common-law partner, all of the following information with respect to that spouse or common-law partner:their gender, full name, all other names used by them and the details of any name changes,their date and place of birth,if they were born in Canada, a copy of their birth certificate,if they were born outside Canada, the information described in subparagraph (c)(ii), andtheir current address, if known;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; andsubject 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.One statement per facilityThe application must include a statement described in paragraph (2)(m) in respect of each separate facility.Exception — inspectorsAn inspector who is designated under section 40 of the Act need not include the statement described in paragraph (2)(m) in their application.
Record checksOn 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 criminal record check;a check of the relevant files of law enforcement agencies, including intelligence gathered for law enforcement purposes;a Canadian Security Intelligence Service security assessment; anda credit check.Additional informationThe Minister may, in writing, request any further relevant information from the applicant for the purpose of making the determination of risk under section 14.
Issuance — risk assessmentThe 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: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;whether it is known or there are reasonable grounds to suspect that the applicantis 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,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,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,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,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, oris 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);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;whether the applicant has previously had a security clearance suspended or revoked;whether the applicant has provided false or misleading information in or in connection with their application;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; andany other relevant information to enable the Minister to assess the risk.
Postponement — outstanding criminal chargesIf 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.
Validity periodThe 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.
Notice of issuance or refusalWhen 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.
Additional facility or part of facilityThe 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.
Notice in writingThe 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.
SuspensionThe Minister may suspend a security clearance on receipt of any of the following information:new information described in any of sections 12 to 14 that was not available for consideration when the security clearance was issued;a notice from the holder of the security clearance under section 19; orthe 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.
RevocationThe 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).Notice to licence holdersOn 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.
Reasons in writingA 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
One person at a timeFor 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.Continuous supervisionA 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.
No access in certain circumstancesFor 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:their security clearance is suspended, orthey 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.
RecordsThe 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
Exemption from Risk Group 2 — risk reductionA 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.Exemption from Risk Group 3 — risk reductionA 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.Exemption from Risk Group 4 — risk reductionA 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.Notice to MinisterIn the circumstances described in subsections (1) to (3), the licence holder must notify the Minister without delay after such a modification.
Exemption from licence requirement — laboratoriesA 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 thatthey do not cultivate or otherwise produce a human pathogen; orif 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.Exemption from licence requirement — veterinary practicesA 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.
Exemption — section 33 of ActA 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:there is no prescribed human pathogen or toxin present in that part of the facility, orany prescribed human pathogen or toxin that is present is locked up and inaccessible to that person.
Documents
Document retentionDocuments 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.Exception — incidentsDespite subsection (1), the retention period is 10 years for documents that contain information that relates to the following incidents:an incident that is described in subsection 12(1) or (2), or section 13 or 14, of the Act; andany incident that results in a failure of or compromise to biocontainment.
Receipt of documentsAny document that is sent by the Minister under the Act is considered to have been received on the earlier of the following days:the day that is five days after it was sent, andthe day on which it is received.
Transitional Provisions
Continuation of controlled activitiesA 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.DurationSubsection (1) applies until the Minister issues or refuses to issue the licence under subsection 18(1) or (3) of the Act, respectively.
Continuation of controlled activities — prescribed human pathogens and toxinsAn 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.DurationSubsection (1) applies until the Minister issues or refuses to issue the security clearance under subsection 34(1) of the Act.
Coming into Force
December 1, 2015These Regulations come into force on December 1, 2015.