What You Should Know About Importing Human Pathogens into Canada
The Public Health Agency of Canada
has regulations to control the importation of human
pathogens into Canada and to ensure that adequate facilities exist
for proper laboratory handling and containment of these pathogens.
These regulations allow the Public Health Agency of Canada to
assess, control and manage the risk of inadvertent transmission of
communicable disease caused by imported pathogens. The regulations
came into effect in 1994.
Questions and Answers
- 1. What is a human pathogen?
A human pathogen is any microorganism or parasite that causes
disease in humans. This includes zoonotics. Human pathogens may be
contained in cultures, diagnostic specimens, or tissue.
- 2. What is an infectious substance?
An infectious substance as defined in the Human Pathogens
Importation Regulations means a microorganism or parasite that
is capable of causing human disease or an artificially produced
hybrid or mutant microorganism that contains genetically altered
components of any microorganism capable of causing human
- 3. What do I need to import a human pathogen into
An application to import human pathogens
into Canada must be submitted to the Pathogen Regulation Directorate, Public Health Agency of Canada. After evaluation and
approval by the Pathogen Regulation Directorate, an importation
permit will be issued which must accompany the shipment of the
pathogen into Canada. A single- or multiple-entry permit will be
issued according to the particular situation.
- 4. How and where do I get a Human Pathogens Importation
Permit application or a copy of the 3rd edition of the Laboratory
Biosafety Guidelines (2004)?
You may obtain application forms or copies of the 3rd Edition of the Laboratory
Biosafety Guidelines (2004) by contacting:
Pathogen Regulation Directorate
100 Colonnade Road, Loc.: 6201A
OTTAWA ON K1A 0K9
Telephone: (613) 957-1779
Facsimile: (613) 941-0596
- 5. How do these regulations interact with Transport
of Dangerous Goods Regulations and other international
Human Pathogens Importation Regulations do not in any
way diminish the responsibility of the importer/shipper to comply
with international and domestic regulations regarding the
transportation and packaging of dangerous goods.
- 6. Before the introduction of these regulations, what
controls were in place for importing these pathogens?
The Canadian Food Inspection Agency has the authority to
regulate the importation of animal pathogens under the Health
of Animals Act. In the past where a human pathogen was
involved, the Canadian Food Inspection Agency, in consultation with
Health Canada, would issue a permit. The new Human Pathogens
Importation Regulations have corrected this situation without
- 7. Will two permits be required (i.e. one from the
Canadian Food Inspection Agency and one from the Public Health
Agency of Canada) to import a pathogen which is both a human and
animal (zoonotic) pathogen?
Yes. Two permits will be required.
- 8. If a human pathogen is a pharmaceutical/drug or
vaccine as described in the Food and Drug Act, do I need a
Human Pathogens Import permit to import it into
No. If a human pathogen is a pharmaceutical/drug or vaccine
regulated by the Food and Drug Act, then a permit to
import human pathogens is not required. However, there may be
specific requirements/restrictions under the Food and Drug Act
and Regulations that apply.
- 9. Will I need a permit to import proficiency panels
used in the verification of clinical diagnostic
Yes. If the importer has reasonable grounds to believe that
there are human infectious substances or toxins of infectious
substances contained in any material, then an import permit is
- 10. What can I do if I am refused a permit to import a
There is an appeal process outlined in these regulations which
may be launched if a permit has been refused.
- 11. How do I determine what laboratory containment
facilities I need?
Depending on your laboratory facilities and equipment and in
conjunction with the identified infectious substance you wish to
import, you should refer to the 3rd Edition of the Laboratory
Biosafety Guidelines (2004) to verify if your laboratory's
containment arrangements are adequate.
- 12. Before I obtain a permit to import a particular
pathogen that belongs to Risk Group 3 or 4, will it be necessary to
have my laboratory facilities inspected?
No, not necessarily. If your laboratory is an established
containment facility that has been certified by the Office of
Laboratory Security and meets the criteria of the 3rd edition of the Laboratory
Biosafety Guidelines (2004), a further review may not be
- 13. Once a permit to import a human pathogen has been
issued, will I be able to import this pathogen anytime I
If a permit to import a human pathogen has been issued, it will
clearly indicate whether it is a single-entry or multiple-entry
permit. Only Risk Group 2 human pathogens can be imported using
Any other questions that we have not answered? Please
The Pathogen Regulation Directorate and we will do our best to answer your
Fax.: (613) 941-0596