Human Pathogens Importation Regulations (SOR/94-558)

Regulations are current to 2012-05-14

SCHEDULE

(Section 6)

FORM 1

Department of National Health and Welfare
Health Protection Branch
Laboratory Centre for Disease Control
Application No.:
Permit No.:
APPLICATION FOR PERMIT TO IMPORT HUMAN PATHOGEN(S)
UNDER THE AUTHORITY OF THE HUMAN PATHOGENS IMPORTATION REGULATIONS
Send applications to:
Office of Biosafety Laboratory Centre for Disease Control
Tunney’s Pasture
Ottawa, Ontario
K1A 0L2
Tel.: (613) 957-1779
FAX: (613) 941-0596
  • 1. 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 TRANSPORTATION

  • 5. 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 IMPORTED

  • 7. 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 USED

  • 9. METHOD OF TREATMENT OF MATERIAL FOR PURPOSES OF DECONTAMINATION, STERILIZATION AND WASTE DISPOSAL

  • 10. WORK OBJECTIVES, PROPOSED PLAN OF WORK AND ADDITIONAL PERTINENT INFORMATION

  • 11. 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 APPLICANT
__________
DATE
  • * 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 Welfare
Health Protection Branch
Laboratory Centre for Disease ControlPermit No.:
PERMIT TO IMPORT HUMAN PATHOGEN(S)
UNDER THE AUTHORITY OF THE HUMAN PATHOGENS IMPORTATION REGULATIONS
IMPORTER: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 DIRECTOR
__________
DATE
  • NOTE: 
    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.