On the Order: Resuming debate on
the motion of the Honourable Senator Eaton, seconded by the
Honourable Senator Gerstein, for the second reading of Bill
C-11, An Act to promote safety and security with respect to
human pathogens and toxins.
Hon. Lillian Eva Dyck:
Honourable senators, I rise today to speak to Bill C-11, an
act to promote safety and security with respect to human
pathogens and toxins. Let me begin by saying that it is
clear from the transcripts of the debates in the other place
and from the committee report on this bill that Bill C-11
was seriously considered and studied in-depth by individual
members and by the Standing Committee on Health. Bill C-11
has been improved significantly by a number of amendments
introduced in the other place.
The purpose or intent of this bill is
to establish a bio-safety and bio-security framework that
allows for the safe handling of human pathogens and toxins.
It is intended to protect the health and safety of Canadians
from infectious diseases resulting from the production,
transport and physical manipulation of human pathogens and
Bill C-11 sets up a system of
classification of these substances based on the severity of
health risks associated with a particular substance.
Appended to this bill are schedules of substances classified
by the severity of the level of risk to human health and by
the type of substance — such as bacteria, viruses and prions.
For example, listeria monocytogenes and Colorado tick fever
virus are listed in Schedule 2 as low-risk agents while West
Nile Virus — which you recall swept across the country a few
years ago — is included in Schedule 3 because it has more
severe health effects on humans. Ebola virus is located in
Schedule 4 with more severe health risks, and smallpox virus
is under Schedule 5, the prohibited pathogens and toxins.
Honourable senators, it is not hard to
imagine that with new scientific discoveries and new
emerging strains of infectious agents, such as the influenza
A H1N1 virus, that these schedules cannot be fixed in stone.
They must be amended from time to time. Bill C-11 sets up
the process to do that in sections 9 and 10. In consultation
with an advisory committee established under the Public
Health Agency of Canada Act, the Minister of Health may add
to or delete items from the schedules of pathogens and
toxins. This allows the schedules to be responsive to public
health concerns over new strains of viruses emerging in
Canada or elsewhere.
Bill C-11 will also protect the health
and safety of those individuals who actually handle these
substances as part of the activities associated with their
occupations. It is likely that this latter group is at
greater risk than the public at large in most instances. For
example, research technicians, research scientists and
trainees who manipulate these substances in their
laboratories will be better protected with the
implementation of Bill C-11.
There are big gaps in the current
legislation that Bill C-11 will fix. Though there are
legislative regulations concerning the importation of human
pathogens and toxins, there are not any concerning their
domestic transport within Canada. Consequently, those
laboratories that acquire toxins and human pathogens
domestically are not required by law to follow bio-safety
guidelines, but do so voluntarily. This situation creates a
potential safety hazard for those who work in unregulated
laboratories, for those involved in the domestic transport
of human pathogens and toxins and for the public at large.
Honourable senators, imagine that you
are a director of a research facility and you wish to carry
out experimental investigations on West Nile virus. It would
make no sense to you that different rules apply, depending
on whether you obtained it from Canadian sources or from
another country. That situation currently exists.
Bill C-11 will change this situation
so that there is a uniform licensing system nationally,
which not only makes sense but also means that there will be
greater safety for everyone. Once enacted, Bill C-11 will
allow for a complete national database of the locations of
human pathogens and toxins. Presently, only the locations of
imported agents are known.
Bill C-11 outlines a comprehensive
system for obtaining a licence to conduct controlled
activities with human pathogens and toxins. The types of
controlled activities are listed in section 7. Thus, for
example, a research scientist would be able to obtain a
licence to acquire human pathogens and toxins, except for
those that are prohibited and listed in schedule 5; and that
research scientist would be able to conduct controlled
activities or experiments that comply with the regulations
to be developed according to this bill.
Honourable senators, once again,
imagine that you are the director of a research facility
after this bill comes into force. Imagine that you have
already obtained a licence so that you can conduct
experiments utilizing a particular human pathogen. To ensure
the safety of the general public and those people who work
with the particular pathogen, you would be required to
appoint a biological safety officer who would be responsible
for overseeing the work with that substance in your
laboratory. In addition, there would be, from time to time,
an inspector who would come to your facility to confirm that
the procedures occurring within your laboratory were
conducted according to regulations — that is, in a safe
There is the possibility, rare I
suspect, that somehow shortcuts have been taken in the
procedures that are being conducted by you or someone else
in the laboratory, and that these shortcuts create an unsafe
condition. That is why having an external inspector check
over the lab records, inventories, notebooks and day-to-day
hands-on procedures is most useful. Such inspections are a
reminder to be vigilant about good laboratory practice, and
official inspections will likely verify that such is the
case in the vast majority of instances.
While this approach may seem to be a
rather odd process, which could be construed as a policing
system, the process is not unusual for those who work in
laboratories. For example, a similar system occurs for those
who work with radioactive compounds. This type of inspection
ensures the safety of the laboratory personnel and the
general public at large.
For those laboratories, however, that
have not been so regulated, it may be seen as an undue
burden to comply with this system outlined in Bill C-11.
However, a balance must be achieved between scientific
freedom and public safety.
Under Bill C-11, clauses 40 to 52
describe the administration and enforcement of the act. For
example, if an inspector finds that things are done in a
manner that poses a serious and imminent danger to the
health and safety of the public, the inspector can order
remedial actions be taken to reduce or eliminate that
Clauses 20 to 22 of the bill outline
the process whereby the minister can suspend or revoke a
licence, and clauses 24 to 29 outline the processes for
appealing such a decision.
Honourable senators, imagine the worst
case scenarios, where the public health and safety has been
endangered — for example, where a person has knowingly
conducted activities with prohibited substances listed in
schedule 5, or situations where a person has intentionally
released a human pathogen or toxin. A system of fines and
possible imprisonment is outlined in clauses 53 to 64, the
severity of which is directly correlated to the risk
associated with the type of pathogen or toxin involved in
In other words, honourable senators,
the fines and lengths of imprisonment increase with the
increasing level of risk to the public health caused by the
particular pathogen. For example, an offence related to risk
group 2, which includes substances that pose a moderate risk
to the health of individuals and a low risk to public
health, carries a lower penalty than an offence related to
risk group 4 substances, which pose a higher risk to an
individual and a high risk to public health.
Honourable senators, imagine that you
are a member of the general public and you wish to see what
is happening in the National Microbiology Laboratory in
Winnipeg, which has a level 4 safety rating, the highest
level. In this facility, scientific staff members are able
to conduct work on human pathogens and toxins at the highest
level of risk to human health and safety permitted.
Some years ago, as a member of the
Science Advisory Board of Health Canada, I visited this
facility. To do so, like every person who enters that
facility, I had to receive a security clearance. This
security makes eminent sense to me, as not everyone should
have potential access to highly infectious and highly
dangerous pathogens and toxins. Clauses 33 to 35 of Bill
C-11 outline the procedures relevant to obtaining a security
clearance from the Minister of Health to enter a facility
that conducts activities with human pathogens that fall into
risk groups 3 and 4.
Honourable senators, no doubt you are
imagining how complicated the system must be to regulate the
types of controlled activities, the types of facilities such
as laboratories, the types of administrative processes, the
qualifications of a licence holder, the biological safety
officer, the inspector, the biosafety guidelines and so on.
The processes whereby these regulations will be developed
are described in clauses 66 to 69. These clauses were
significantly amended in the other place to incorporate the
level of risk associated with the human pathogens and
toxins, and the process whereby the proposed regulations are
to be reviewed by both houses of Parliament.
Bill C-11 will be implemented in three
phases. After Royal Assent, the first phase requires every
person who has a human pathogen or toxin to inform the
Minister of Health, and in the case of schedule 5 agents,
which are the most dangerous, to dispose of any according to
the minister's instructions. The first phase allows the
minister to know who has what pathogens and toxins and where
they are located, and allows for the disposal of the most
In addition, the clauses dealing with
prohibited activities, offences and penalties and other
provisions, except those under clause 7, which outline the
controlled activities that are prohibited unless licensed to
do so by the minister, will come into force.
The second phase of implementation of
this bill is to develop the regulatory framework. The third
phase provides a timeline for stakeholders to come into
compliance with the bill.
Honourable senators, Bill C-11 has
been reviewed and debated in depth in the other place. There
were seven committee hearings in the other place; there were
five government witnesses and 13 other witnesses that
appeared before the committee, and numerous debates.
Of particular note are the significant
amendments that were made to the bill to address concerns
related to important clauses of the bill, some of which I
have already mentioned, such as the incorporation of clauses
that direct the Minister of Health to consult an advisory
committee before making any changes to the substances listed
in the schedules.
Concerns with respect to the Privacy
Act were expressed at third reading. It was suggested that
this house of sober second thought and the review committee
give these concerns further consideration. Nonetheless, the
bill was passed in the other place with a resounding
Honourable senators, Bill C-11 is a
sound and important piece of legislation that balances the
need for ensuring that the safety of all Canadians is not
compromised by the activities associated with the
production, transport, handling and disposal of human
pathogens and toxins. It closes significant loopholes in
current legislation and it proposes a national system of
regulation that meets the standards of other countries, such
as the United States of America.
The Hon. the Speaker:
Is it your pleasure, honourable senators, to adopt the
(Motion agreed to and bill read second
Referred to Committee
The Hon. the Speaker:
When shall this bill be read the third time?
(On motion of Senator Comeau, bill
referred to the Standing Senate Committee on Social Affairs,
Science and Technology.)