Submission from the British High Commission,
The Public Health Agency of Canada classifies
pathogens using a risk system based on pathogenicity and mode
of transmission. Recently there has been a shift towards classification
using minimal containment levels required to provide safe manipulation
of pathogens. (Paragraphs 1-2)
The agencies responsible for overseeing bio-security
in research facilities in Canada are the Public Health Agency
of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA),
while transportation of pathogens into Canada falls under the
jurisdiction of Transport Canada. Dangerous pathogens require
permits from the Public Health Agency of Canada, Transport Canada
and the Canadian Food Inspection Agency for their use in research
facilities. In addition, laboratory facilities handling dangerous
pathogens require prior certification from PHAC and where applicable,
CFIA. (Paragraphs 3-9 and 15)
The Public Health Agency of Canada publishes
a manual with guidelines to follow for the design, construction,
maintenance and protocols to be used in containment laboratories.
This provides a set of general recommendations for facilities
to follow when developing their own protocols and procedures.
In the case of university laboratories, a bio-safety committee
is appointed by the university to deal with all matters related
to laboratory bio-safety and bio-security. (Paragraphs 10 and
All facilities dealing with dangerous pathogens
are required to have inventory controls and emergency plans in
place as part of their operational protocols, however there is
no universal or standard procedure available to account for missing
pathogenic material. Facilities are responsible for devising their
own methods for inventory control and emergency preparedness.
These activities are strongly encouraged by the Public Health
Agency of Canada as well as public funding agencies. (Paragraphs
By what mechanism(s) are micro-organisms classified
with regards to their potential danger and their need to be contained?
1. The Public Health Agency of Canada classifies
micro-organisms based on a risk level system that depends on pathogenicity,
mode of transmission, availability of preventive measures and
treatments, and severity of economic or health consequences brought
about by a potential wide-spread infection. Recently there has
been a shift towards classification of pathogens based on their
handling requirements using four biological containment levels.
What are the categories of biological containment
2. There are four progressively stringent
containment levels in use, depending on the type of agents handled
and based on the minimum containment level required for safe manipulation
of pathogens. These containment levels indicate the operational,
physical, engineering and technical constraints required for safe
handling of pathogens. These procedures are in turn based on the
pathogenicity, potential for serious health and economic consequences,
and preventive measures and treatments available for particular
How are licenses to use dangerous pathogens in
3. Dangerous pathogens require importation
permits depending on their source and the containment level required
for their manipulation. The import and use of human pathogens
is regulated by the Human Pathogens Importation Regulations and
requires a permit issued by the Office of Laboratory Security
at the Public Health Agency of Canada.
4. Human pathogens requiring containment
levels 2, 3 and 4 require a valid permit. These permits allow
for the import, use and storage of dangerous pathogens. Before
issuing a permit, the Public Health Agency of Canada will inspect
the research laboratory to ensure that criteria for containment
level is adequate and that operational, mechanical and physical
bio-safety and bio-security attributes are in place to handle
pathogens at the specified containment level. After evaluation
of the permit application and inspection of laboratory facilities,
a permit is issued for single or multiple entries of the pathogen
into Canada, on a case by case basis. http://www.phac-aspc.gc.ca/ols-bsl/pathogen/index.html
5. Permits for animal and plant pathogens
are awarded by the Canadian Food Inspection Agency. In the case
of zoonotic pathogens which can be transmitted from animals to
humans, two separate permits are required, one from the Public
Health Agency of Canada and another one from Canadian Food Inspection
Agency. Both agencies will be involved in the inspection and certification
of the laboratory facilities in this case.
What is the inspection regime for laboratories
licensed to use dangerous pathogens?
6. Facilities for containment levels 3 and
4 require certification from the Public Health Agency of Canada
for handling dangerous pathogens. There are approximately 90 containment
level-3 laboratories and a single level-4 facility in Canada.
7. In order to initially certify containment
level 3 and 4 facilities, the Public Health Agency of Canada will
inspect the research laboratories to ensure that criteria for
containment level is adequate and that operational, mechanical
and physical attributes are in place for handling the pathogenic
material. Guidelines to prepare for these inspections are provided
by the Public Health Agency of Canada.
8. Furthermore, level-4 facilities undergo
a yearly inspection to ensure that bio-safety attributes are maintained
and updated. Level-3 facilities do not undergo further inspection
after the initial certification, however in order to maintain
their certification they are required to submit a form documenting
any changes undergone in the facility after the initial certification
on a yearly basis.
9. Finally, if zoonotic pathogens are concerned,
the Canadian Food Inspection Agency is also involved in the initial
inspection for certification of level-3 facilities.
What training is mandatory/recommended for staff
working in containment facilities?
10. Guidelines for training staff in all
containment facilities is provided by the document Laboratory
Bio-safety Guidelines published by the Public Health Agency
of Canada. This document is sent to facilities upon request or
can be accessed through the agency's web-site.
11. Training is mandatory for certification
of level-3 and 4 facilities, as it is evaluated as part of the
Standard Operating Procedures for certification of these facilities.
Training on potential hazards, reducing infection risks, operational
procedures, decontamination and emergency protocols are recommended
for containment level 2 to 4 laboratories. In addition, requirements
for training staff in the physical operation and design of the
facility are required for containment levels 3 and 4.
12. There are no standard training programmes
outlined, however the Public Health Agency of Canada requires
evidence that the training undertook is specific to the pathogens
handled and that staff have completed and understood the training
13. An instructional DVD on operational
procedures for containment level-3 laboratories is available at
a moderate cost from the Public Health Agency of Canada.
14. The Public Health Agency of Canada will
be holding its second annual Canadian Bio-safety Symposium on
1-3 June this year. http://www.phac-aspc.gc.ca/ols-bsl/l3-n3-2003/index.html
What are the regulations regarding the storage
and transportation of dangerous pathogens?
15. Regulations for storage and transportation
of dangerous pathogens are under the authority of Transport Canada.
Transport Canada regulations require an additional permit for
transport and storage of dangerous pathogens under the category
of Infectious Substances and Biological Products in the Transportation
of Dangerous Goods Act. Compliance with these regulations involves
following containment specifications and providing Transport Canada
with information on staff training and storage or disposal procedures.
What measures are in place to be implemented when
pathogenic material cannot be accounted for?
16. Measures to account for missing pathogenic
material fall under the responsibility of the facility. However,
as part of the certification criteria for level-3 and 4 laboratories,
a plan to control accidents involving dangerous pathogenic material
and an inventory of the pathogens in the facility must be included
in the Standard Operating Procedures submitted to the Public Health
Agency of Canada. However currently there is no standard protocol
in place for maintenance of inventories or emergency preparedness
plans for laboratories to follow. Facilities are encouraged to
report incidents to the local law authorities.
17. However, in case of highly infectious
substances belonging to risk groups 3 and 4
the Public Health Agency of Canada must be informed if shipments
of pathogens go missing or are delayed during their importation
into Canada or while they are being transported from one facility
to another within Canada.
18. Further control and compliance over
incidents involving pathogenic material is indirectly exerted
by funding agencies and provincial governments, which require
that facilities be compliant with the guidelines indicated in
the Guidelines for Laboratory Bio-safety produced by the Public
Health Agency of Canada to authorise funding.
Who is responsible for overseeing security clearance
for research students working with dangerous pathogenswhat
is the role of universities in this process?
19. Each university designates a bio-safety
committee, which is responsible for overseeing security clearance
requirements for students working with dangerous pathogens. All
containment level-3 laboratories require all staff, from support
to research staff working within the facility to undergo security
31 Reference is made to the risk groups in Appendix
3 of the Toxic and Biological Substances classification under
the Transportation of Dangerous Goods Act, Transport Canada. Back