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

2. In these Regulations,

“diagnostic specimen”

“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”

“Director” means the Assistant Deputy Minister, Health Protection Branch, Department of National Health and Welfare; (directeur)

“Guidelines”

“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”

“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”

“importation permit” means a permit to import one or more human pathogens that is provided for by these Regulations; (permis d’importation)

“infectious substance”

“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”

“Risk Group” means a risk group described in the Guidelines. (groupe de risque)

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.

• 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.