H-3.2Department of Health ActSOR/94-55819948

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DEPARTMENT OF HEALTH ACTHuman Pathogens Importation RegulationsRegulations Respecting the Importation of Human Pathogens and Their TransferP.C.1994-1359  19948

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His Excellency the Governor General in Council, on the recommendation of the Minister of National Health and Welfare, pursuant to section 12 of the Department of National Health and Welfare Act, is pleased hereby to make the annexed Regulations respecting the importation of human pathogens and their transfer.SHORT TITLE

1.These Regulations may be cited as the Human Pathogens Importation Regulations.

INTERPRETATION

2.In these Regulations,diagnostic specimen means any human or animal material, including excreta, secreta, blood and its components, tissue and tissue fluids, that is to be used for the purposes of diagnoses, but does not include live infected animals; (spécimen diagnostique)Director means the Assistant Deputy Minister, Health Protection Branch, Department of National Health and Welfare; (directeur)Guidelines means the Laboratory Biosafety Guidelines, as amended from time to time, established by the Department of National Health and Welfare and the Medical Research Council of Canada; (Lignes directrices)human pathogen means(a)an infectious substance,(b)the toxin of an infectious substance, or(c)any diagnostic specimen or other material that contains, or that its importer has reasonable grounds to believe contains, an infectious substance or the toxin of an infectious substance; (agent anthropopathogène)importation permit means a permit to import one or more human pathogens that is provided for by these Regulations; (permis d’importation)infectious substance means(a)a micro-organism or parasite that is capable of causing human disease, or(b)an artificially produced hybrid or mutant micro-organism that contains genetic components of any micro-organism capable of causing human disease; (matière infectieuse)Risk Group means a risk group described in the Guidelines. (groupe de risque)

APPLICATION

3.These Regulations do not apply(a)to a human pathogen that is a drug within the meaning of the Food and Drugs Act; or(b)to an animal pathogen, or toxins thereof, incapable of causing human disease.

REQUIREMENTS

4.(1)No person shall import a human pathogen that belongs to Risk Group 2, 3 or 4 unless(a)the importation is in accordance with a subsisting importation permit issued to that person under paragraph 7(a);(b)prior to shipment of the human pathogen, that person notifies the supplier that the outer shipping container in which the human pathogen is transported must display clearly, on the outside surface of the container, the importation permit number and the following statement immediately preceding that number:“Human Pathogen — Importation Permit Number:/ Agent anthropopathogène — Numéro du permis d’importation :”; and(c)prior to shipment of the human pathogen, that person provides a copy of the importation permit to the supplier and notifies the supplier that a copy of the importation permit must accompany each shipment.(2)An importation permit is not valid for more than one entry into Canada(a)in respect of human pathogens that belong to Risk Group 3 or 4; and(b)in respect of human pathogens that belong to more than one Risk Group.

5.(1)A person who, after arranging to import a human pathogen that belongs to Risk Group 3 or 4, does not receive the human pathogen on, or within three days after, such date of receipt as may reasonably be expected in the circumstances shall forthwith give to the Director a notice that the person has not received the human pathogen and provide the Director with the importation permit number.(2)A person who, after arranging to import the human pathogen referred to in subsection (1), does not receive the human pathogen when it is expected shall forthwith take all reasonable measures to locate the human pathogen.

IMPORTATION PERMITS

6.(1)An application for an importation permit must be submitted to the Director in Form 1 of the schedule.(2)When considering an application made in accordance with subsection (1), the Director may, to ensure that the health of the public will be preserved, require the applicant, by notice in writing, to(a)furnish any information and materials in addition to the information contained in the application; and(b)in the case of an application relating to a human pathogen that belongs to Risk Group 3 or 4, allow an officer of the Laboratory Centre for Disease Control, Health Protection Branch, Department of National Health and Welfare, or any other person, designated by the Director, to inspect, at any reasonable time, the physical biocontainment levels and the mechanical systems, operational protocols and laboratory waste disposal facilities that the applicant proposes to use.

7.After considering an application made in accordance with section 6, the Director shall(a)issue to the applicant an importation permit, in Form 2 of the schedule, if it appears from the application, together with any information or materials furnished and the results of any inspection made under paragraph 6(2)(b), that the applicant’s facilities, equipment and proposals are such as to meet the applicable operational and physical requirements of the Guidelines; or(b)by notice in writing sent by registered mail to the applicant, refuse to issue an importation permit, if the condition set out in paragraph (a) is not satisfied.

8.(1)The Director, by notice in writing sent by registered mail to a person to whom an importation permit has been issued under paragraph 7(a), may suspend, for a period indicated in the notice, or cancel the permit if the Director believes on reasonable grounds that any provision of these Regulations, in so far as it applies in respect of the importation or importation permit, or any of the terms and conditions of the permit, have not been complied with.(2)A person to whom a notice of suspension or cancellation is sent pursuant to subsection (1) shall forthwith surrender the importation permit to the Director.(3)On the expiration of any period for which an importation permit is suspended, the Director shall return the importation permit to the person who surrended it under subsection (2).

9.A notice referred to in paragraph 7(b) or subsection 8(1) shall be deemed to have been received by the person on the earlier of(a)the date the person signed for the delivery of the notice, and(b)7 days after the date the notice was mailed.

10.A notice of refusal under paragraph 7(b), or of suspension or cancellation under subsection 8(1), shall specify the grounds of the refusal, suspension or cancellation.

11.(1)Within 30 days after receiving a notice of refusal, suspension or cancellation, a person who is dissatisfied with the decision of the Director may, by notice in writing that states the reasons for the dissatisfaction, request the Director to refer the decision to a committee.(2)Where the Director receives a request under subsection (1), the Director shall refer to a committee, constituted in accordance with section 12, the decision to which the request relates.

12.(1)A committee referred to in section 11 shall consist of three members.(2)One of the members of a committee shall be appointed by the Director and another of its members shall be appointed by the person who requested the referral to a committee under section 11.(3)The two members appointed pursuant to subsection (2) shall appoint the third member of the committee, who shall be its chairperson, or, if they are unable to do so within a reasonable time, the Director shall appoint the third member of the committee, who shall be its chairperson.(4)No person who is employed by the Department of National Health and Welfare or by the person who requested the referral to a committee shall be appointed as a member of the committee.

13.A committee to which a decision is referred under section 11 shall consider(a)the grounds of the decision, as specified in the notice referred to in section 10;(b)the reasons stated under subsection 11(1) by the person who requested the referral; and(c)any representations, information or material submitted to the committee by the Director or that person.

14.A committee shall, within 30 days after the referral of a decision, report the committee’s findings and recommendations respecting the decision to the Director and to the person who requested the referral.

15.(1)The Director, within 15 days after receiving the report of the committee’s findings and recommendations, shall consider those findings and recommendations and(a)reconsider the decision in respect of which the report was made; and(b)notify in writing the person who requested the referral of the final decision of the Director.(2)Where the final decision of the Director is to set aside the cancellation of an importation permit, the Director shall restore the importation permit by sending it, together with the notice required by paragraph (1)(b), to the person who surrendered the importation permit under subsection 8(2).

16.(1)Subject to subsection (3), a person who imports a human pathogen that belongs to Risk Group 3 or 4 shall keep the pathogen in the facilities located at the address indicated in the application for an importation permit and shall ensure that the human pathogen is used only for work carried out or directed by the person in those facilities.(2)A person who has imported a human pathogen and who intends to transfer the human pathogen to another person shall submit an application in writing to the Director that sets out(a)the importation permit number for the human pathogen;(b)the intended date of transfer;(c)the name and address of the person to whom possession of the human pathogen is to be transferred together with that person’s written consent to the transfer and written undertaking to comply with the conditions of the importation permit;(d)the address and description of the facilities to which the human pathogen is being transferred; and(e)the transport arrangements for the movement of the human pathogen.(3)The Director, after receiving an application referred to in subsection (2), may issue an approval in writing for the transfer of a human pathogen to a person described in paragraph (2)(c) if the health of the public would not be endangered by the transfer, and(a)the facilities and the equipment of the location where the human pathogen is to be transferred meet the applicable operational and physical requirements of the Guidelines for the type of human pathogen being transferred;(b)the transport arrangements referred to in subsection (2) will ensure that the health of the public is preserved; and(c)the person to whom the human pathogen is transferred undertakes in writing to comply with any other conditions that the Director may impose in the circumstances in order to preserve the health of the public.(4)For the purpose of determining whether to approve a transfer of a human pathogen, the Director may, if the Director believes on reasonable grounds that the health of the public will be preserved by doing so require the applicant by notice in writing to(a)furnish any information in addition to that contained in the application; and(b)allow an officer of the Laboratory Centre for Disease Control, Health Protection Branch, Department of National Health and Welfare, or any other person, designated by the Director to inspect, at any reasonable time, the physical biocontainment levels and the mechanical systems, operational protocols and laboratory waste disposal facilities that are intended to be used.

17.No person shall breach any term or condition of an importation permit or of the approval referred to in subsection 16(3).

18.No person shall knowingly submit any false or misleading information or materials, or make any false or misleading representation, to the Director or a committee.

19.Every person who contravenes section 4, subsection 5(1) or (2) or 8(2), or section 17 or 18, is guilty of an offence and is liable on summary conviction to a fine not exceeding $200 or to imprisonment for a term not exceeding three months.

SCHEDULE(Section 6)FORM 1Department of National Health and WelfareHealth Protection BranchLaboratory Centre for Disease ControlApplication No.:Permit No.:APPLICATION FOR PERMIT TO IMPORT HUMAN PATHOGEN(S)UNDER THE AUTHORITY OF THE HUMAN PATHOGENS IMPORTATION REGULATIONSSend applications to:Office of Biosafety Laboratory Centre for Disease ControlTunney’s PastureOttawa, OntarioK1A 0L2Tel.: (613) 957-1779FAX: (613) 941-05961.APPLICANT: (Name, address, postal code and telephone number)2.SUPPLIER: (Name and address)3.DESCRIPTION OF MATERIAL COMPRISING HUMAN PATHOGEN (Including name of material, country of origin and human or animal source)4.MODE OF TRANSPORTATION5.CANADIAN PORT(S) OF ENTRY (NOTE: NOT MORE THAN ONE ENTRY IS PERMISSIBLE IN THE CASE OF A HUMAN PATHOGEN THAT BELONGS TO RISK GROUP 3 OR 4)6.QUANTITY OF MATERIAL TO BE IMPORTED AND, IN THE CASE OF A HUMAN PATHOGEN BELONGING TO RISK GROUP 2, ANY INTERVALS AT WHICH, OR PERIOD DURING WHICH, THE PATHOGEN IS TO BE IMPORTED7.DESCRIPTION OF APPLICANT’S FACILITIES AND EQUIPMENT FOR HANDLING MATERIAL (NOTE: APPROPRIATE CONTAINMENT IS REQUIRED: SEE THE LABORATORY BIOSAFETY GUIDELINES, AS AMENDED FROM TIME TO TIME, ESTABLISHED BY THE DEPARTMENT OF NATIONAL HEALTH AND WELFARE AND THE MEDICAL RESEARCH COUNCIL OF CANADA)8.ADDRESS OF LOCATION WHERE THE HUMAN PATHOGEN IS TO BE USED9.METHOD OF TREATMENT OF MATERIAL FOR PURPOSES OF DECONTAMINATION, STERILIZATION AND WASTE DISPOSAL10.WORK OBJECTIVES, PROPOSED PLAN OF WORK AND ADDITIONAL PERTINENT INFORMATION11.I undertake that the material comprising the human pathogen will, in the event of its importation, be used in accordance with the terms and conditions of the importation permit, and I certify that the facilities in which the material will, in that event, be manipulated and stored meet Containment Level 1 2 3 4 (Check one only).*SIGNATURE OF APPLICANTDATE* NOTE:PHYSICAL CONTAINMENT LEVELS AND MECHANICAL SYSTEMS, OPERATIONAL PROTOCOLS AND LABORATORY WASTE DISPOSAL FACILITIES ARE SUBJECT TO VERIFICATION AS MAY BE REQUIRED BY THE DIRECTOR.FORM 2(Paragraph 7(a))Department of National Health and WelfareHealth Protection BranchLaboratory Centre for Disease ControlPermit No.:PERMIT TO IMPORT HUMAN PATHOGEN(S)UNDER THE AUTHORITY OF THE HUMAN PATHOGENS IMPORTATION REGULATIONSIMPORTER:SUPPLIER:To clear customs at port(s) of entry of:For the importation of: ON THE FOLLOWING TERMS AND CONDITIONS, AS MARKED:1.□Work involving any of the imported material shall be limited to in vitro laboratory studies.2.□Domestic animals, including poultry, cattle, sheep, swine and horses, shall not be directly or indirectly exposed to infection by any of the imported material.3.□All animals exposed to infection by any of the imported material shall be so exposed and held only in isolated insect- and rodent-proof facilities.4.□All equipment, animal pens, cages, bedding, waste and other articles under the importer’s control, that come in direct or indirect contact with any of the imported material, shall be sterilized by autoclaving or incinerated.5.□Packaging materials, containers and all unused portions of the imported material shall be sterilized by autoclaving or incinerated.6.□No work on the imported material shall be done, except work conducted or directed by the importer in the facilities described in the application for this permit.7.□On completion of the importer’s work involving the imported human pathogen, the pathogen and all its derivatives shall be destroyed.8.This permit is valid only for□(a) a single entry into Canada.□(b) importations (at intervals of ) (during the period beginning on , 19 and ending on , 19.)SIGNATURE OF DIRECTORDATENOTE:Transporting and otherwise dealing with the imported material are subject to federal, provincial and municipal laws, to the extent, if any, that those laws apply in respect of that material.