Health Committee on March 10th, 2009

[The Chair, Conservative, Joy Smith]

Good afternoon, everybody.

I certainly want to welcome our witnesses today. We're quite looking forward to what you have to present to us on Bill C-11.

Committee, as you know, from each organization there's one person per organization who's going to give a 10-minute introduction.

We have in front of us, from the Association of Medical Microbiology and Infectious Disease Canada, Alicia Sarabia, who is section head of medical microbiology at the Credit Valley Hospital. Welcome, Doctor.

We have, from the Ontario Agency for Health Protection and Promotion, Vivek Goel, president and chief executive officer; and we have Don Low, medical director of public health laboratories. Welcome to both of you here today.

From the University of Calgary, we have Dr. Michael Hynes, professor, Department of Biological Sciences. Welcome, Doctor.

And from the Institut Armand-Frappier, we have Dr. Albert Descoteaux.

We welcome you all.

We will start with Dr. Alicia Sarabia.

[Dr. Alicia Sarabia, Section Head, Medical Microbiology, The Credit Valley Hospital, Association of Medical Microbiology and Infectious Disease Canada]

Thank you for inviting me to speak today.

First I would like to give you a little bit of background information. I'm an infectious diseases specialist and medical microbiologist working out of the community lab situated in a hospital, the Credit Valley Hospital in Mississauga. I also have a fair amount of experience working with community or what are otherwise called private labs in the province of Ontario. I have less experience working in academic-based laboratories, but I've sought out the opinions of my colleagues in those areas in order to represent them well today.

I'm chair of the microbiology committee of the Ontario Medical Association's quality management program. This program tests proficiency amongst all licensed diagnostic microbiology labs in the province. So I have a feel for the lab work that's going on in our province with regard to diagnosis.

As you know, I'm also section head of medical microbiology in the national Association of Medical Microbiology and Infectious Disease.

Now for a little bit of background and a very high-level description of diagnostic labs in our country. The labs are based out of a number of different settings. They are based out of hospitals and community labs, most of which are privately run. And they are based out of the public health laboratories, which often serve as referral labs for work that takes place initially in the hospitals and private labs and then is brought into the public health labs for investigations of such things as outbreaks, for example.

There is a huge variation among these labs. Some labs are very, very small. They are run by a handful, literally, of people who may be trained not only in microbiology but also in chemistry and hematology, for example. Then other labs are run by hundreds of people, and they're very sophisticated, complex organizations.

The volumes of specimens will vary tremendously across the laboratories, as will the diagnostic platforms. Some labs will do some very basic microbiology, such as basic testing on throat swabs submitted to them, while others will do all sorts of testing, such as diagnostics to look for viruses, bacteria, parasites, and fungi.

This all needs to be taken into account when we study the legislation, especially considering the potential work, resources, and administrative changes that will be required of some of these labs.

The research labs can of course be based out of academic centres and public health labs as well as many private laboratories across the country. Canada has a strong reputation in research within the realm of microbiology. We see, in medical journals and international meetings, representation by our Canadian research labs in microbiology.

Bill C-11, as we all know, focuses on biosafety and biosecurity. I understand the footprint associated with biosecurity has become a bit smaller as the legislation has become more refined. It does take off from current lab biosafety guidelines published in 2004. My understanding is that the playing field is to be levelled for all labs across the country so that regulations can ensure that labs practice the same way when it comes to biosafety and biosecurity, depending on the risk associated with the pathogens being processed in their midst.

Our recommendations and concerns are as follows. I'd make a comment first, that we do applaud, of course, the focus on biosafety and biosecurity because it does reflect the culture of concern for public health. We worry, perhaps, that public health may be compromised if the program and regulatory frameworks associated with this bill are too restrictive, thereby limiting lab efforts and diagnostics and research.

So we feel that it is very important to strike a balance in the interest of preserving and improving public health, and thus have lab biosafety/biosecurity on the one hand, but also continue to produce essential research and diagnostic findings on the other hand to maintain the public health of our citizens.

When it comes to the functional application of the legislation and the regulatory framework, we're not quite sure what's in store for us. There have been information sessions that have been held by the Public Health Agency of Canada, and some questions have been addressed. But because the legislation is still fairly high-level, we're still not clear--some of us--as to what the details will entail. It does leave some of us asking if that balance of biosafety and biosecurity against advancing diagnostic research findings will remain.

We strongly feel that a good solid communications structure will need to be built in order to have this work out. A respectful, open, and bidirectional flow of information between the Office of Laboratory Security at the Public Health Agency of Canada and the key stakeholders--including AMMI Canada, my organization--will be required for this to be successfully implemented and executed.

During the development of this framework, issues like the following will require review in much greater detail.

We need to know exactly, or work together to determine, what the implementation timelines will be. We would recommend that a phasing-in of the various elements of the program occur, rather than that everything happen at once.

We need to know and discuss details of the security clearance criteria. These, of course, need to be clearly defined. And we need to discuss the impact of authorization, of keeping tabs on individuals entering and exiting labs, on the workload of laboratories versus their resources for managing it. How can this happen?

We need to know more about the nature of inventories that will be required by labs possessing various risk group pathogens. We strongly feel that tools, for example, need to be developed by the Office of Laboratory Security in conjunction with stakeholders so that people aren't inventing their own wheels to comply with the regulations.

We also feel that the Office of Laboratory Security and its key stakeholders need to discuss opportunities for maximizing efficiencies. In Ontario, for example, we're inspected by a provincial group that ensures biosafety and security. In order to import pathogens from the U.S., for example, we already fill out a questionnaire that's about 21 pages long, and it takes weeks to months, sometimes, to fill it out. So we have to ensure that in being compliant with this important legislation we're not up to the ceiling with paperwork.

Also, I think we need to further fine-tune the security requirements, depending on specific organism biosecurity risk. In the legislation we refer to risk group pathogens. I feel that even within one risk group--let's say risk group 3--there are pathogens that present varying levels of biosecurity risk. We need to refine this more so that the resulting program becomes a practical, feasible, and safe piece of legislation to work with.

In closing, I'd like to say that, again, the objective is to achieve a balance of biosafety and biosecurity within our labs while maintaining excellence in diagnostic and research efforts to promote public health. To have this occur, we need that very strong communication structure. And we need to know that the resulting regulatory framework and program are really a function of the partnership that will exist between the Office of Laboratory Security and its key stakeholders.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you so much for your insightful comments.

We'll hear from Dr. Goel, president and chief executive officer of the Ontario Agency for Health Protection and Promotion. You're next up.

[Dr. Vivek Goel, President and Chief Executive Officer, Ontario Agency for Health Protection and Promotion]

Thank you. Good afternoon. I would like to thank the honourable members of this committee for the invitation to present to you today.

Biosecurity is clearly a significant issue for Canada, and I'm pleased to share comments and recommendations on behalf of Ontario's new public health agency.

My name is Vivek Goel. I'm a public health physician and the agency's president. I'm also a professor at the Dalla Lana School of Public Health at the University of Toronto. Joining me today is Dr. Don Low, the medical director of our public health laboratories, microbiologist-in-chief at Mount Sinai Hospital, and professor of laboratory medicine and pathobiology at the University of Toronto. Dr. Low is one of the heroes of SARS, who worked tirelessly throughout the outbreak to help protect the health of Canadians. Since then he has been outspoken in his commitment to the renewal of our public health laboratories.

The Ontario Agency for Health Protection and Promotion was created by legislation in 2007 as a result of a number of expert panels and task forces established post-SARS. Similar to the creation of the Public Health Agency of Canada, the goal is to strengthen the public health system. Among other things we provide specialized scientific and technical advice and on-the-ground support to front-line health care workers, public health units, and government. We have a broad mandate that includes infectious disease control, health promotion, chronic disease and injury prevention, environmental and occupational health, and health emergency preparedness, including assisting in responses to bioterrorism.

On December 15, 2008, the Ontario public health laboratories transferred from the Ministry of Health and Long-Term Care to the OAHPP. More than 600 staff work in the public health laboratories, which operate in 12 sites across Ontario. Our labs perform over four million laboratory tests annually. Our ability to generate laboratory data and use it efficiently and effectively to generate tools and technology to inform the public health and broader health systems will be key to our success.

The proposed legislation is laudable in its attempt to codify into statute a number of existing biosafety and biosecurity guidelines, and it addresses an issue of critical importance. We appreciate the information sessions that have taken place and the revisions that have been made. We also appreciate recent assurances we received from Dr. Tam and Dr. Butler-Jones that there will be further consultation, particularly as regulations are developed. We look forward to having an opportunity to truly provide input.

We have concerns related to several specific areas of the proposed legislation, particularly given the absence of draft regulations. We would prefer to see the most critical issues addressed in advance of passage of the legislation.

As drafted, the legislation confers broad powers on the minister in the use of a long list of pathogens and toxins. Based on the legislation alone, the potential for duplicate regulatory licensing and inspection regimes is very significant. The potential workload implications and resulting delays could significantly impact on the operation of clinical, public health, and research laboratories.

The bill provides for broad regulation-making powers. These powers relate to a broad range of topics such as facilities, security clearances, inventories, and licensing. In addition, the proposed legislation includes a provision whereby regulations may incorporate by reference any documents produced by persons or bodies other than the minister.

Given these broad powers, including the incorporation by reference, and the broad range of topics that may intrude into areas of provincial responsibility, it would be preferable if the bill included an explicit obligation on the minister to undertake public consultations. We recommend that the bill be amended to include a specific notice requirement, such as a publication advance of 60 days, and a requirement that the minister consider public comments or submissions and report back on what changes if any have been made as a result.

We understand that there is a clear process for guiding the development and posting of federal regulations, but it does not provide statutory requirements for the type of consultation we have proposed.

Central to Bill C-11 is the requirement for ministerial licences. Our public health laboratories already operate under the laboratories licensing act and follow routine accreditation. The proposed bill appears to create what is, in effect, a duplicate laboratory licensing regime.

We suggest that opportunities for harmonizing the licensing with existing regimes be considered.

The bill proposes that all accidental exposures to listed agents be reported federally. This runs the risk of intersecting with occupational health and safety requirements, and we recommend that overlap with those existing requirements be examined and eliminated.

As others have noted, the requirements for security checks could provide for very onerous burdens. We already have security checks in place for a number of individuals who are working in our laboratories who have access to certain types of pathogens. These security checks, as you have heard, could have a significant impact on training and students, as well as on our ability to bring in additional staff when we have to add surge capacity during an outbreak.

We recommend clarification of the requirements for security clearance for different categories of workers and an assurance that there will be appropriate processes for circumstances such as we have described.

Clause 38 of the bill spells out an extremely broad ability for the minister to order an applicant to disclose personal information. Central to our concern is the excessive breadth of this requirement and the lack of a reasonable test for the information that is being requested. We would like to see much greater detail in the bill regarding these powers.

In conclusion, we support the spirit and intent of Bill C-11 but feel that there are far too many unanswered questions at this stage.

We note that in the United States, following publication of similar legislation, many laboratories simply chose to stop working with listed pathogens rather than face the hassles and costs of complying with the legislation. The net result was diminished capacity to face public health threats.

We believe that an approach to biosafety and preparedness should be comprehensive and engage the laboratory and scientific community. We support the proposal by Dr. Peter Singer, who appeared before you last week, for a comprehensive assessment of Canada's readiness for bioterrorism through the Council of Canadian Academies.

In summary, the proposed bill creates what could become a significant duplicate inspection and compliance regime that imposes administrative burdens and costs.

Thank you for this opportunity to share our concerns and recommendations. We look forward to your comments and questions.

[The Chair, Conservative, Joy Smith]

Thank you very much, Dr. Goel.

We'll now go to Dr. Michael Hynes, from the University of Calgary.

[Dr. Michael Hynes, Professor, Department of Biological Sciences, University of Calgary]

I would like to thank the honourable members and the committee for giving me an opportunity to speak today. I'm here on behalf of the Canadian Society of Microbiologists, of which I am the president--that's an elected office, and it just happens to be me this year. This is a society of about 400 to 500 members that represents all microbiologists in Canada who are willing to join. They're primarily research microbiologists in universities and government labs, but we do have some clinical microbiologists who are members as well. We do liaise quite a lot with some of the other societies in Canada, including the Canadian College of Microbiologists, which is a professional accreditation organization, so they've given me some feedback as well.

I'm a professor at the University of Calgary. My own research is in microbial genetics. I don't work with pathogens, so this legislation does not affect me personally. I don't have any axe to grind. I have based my comments on what I think is going on and largely on responses to this bill from my members. Usually when you send out a request for input from members in a society such as mine you get nothing. I've been overwhelmed with the response I've received about this bill, by e-mail comments, phone calls, conversations. This was also reflected last year at our annual general meeting; we've devoted a considerable amount of time to the discussion of C-54.

People are concerned because they don't really understand the necessity for this legislation in its proposed form. The track record of the microbiology community in Canada is excellent. Existing biohazard guidelines that are in practice for university and government labs are respected and they seem to be working, so there is a lot of concern within our society. Most of this arises from the fact that the level two containment you find in the guidelines from the Public Health Agency of Canada state explicitly that organisms in this group pose little risk to the community, and thus many members of our society feel there's no need to legislate to include them in any toxins and pathogens act.

I got lots of comments about this. Perhaps the most apposite is from one scientist who said I'd be much safer camping in his lab for two weeks than going to a hospital because I'm much more likely to get a serious infection in a hospital. Really, it's the inclusion of level 2 pathogens in this bill that has people concerned.

A second major concern is that E. coli is included in the bill on the list of level 2 pathogens, when under current guidelines, only pathogenic strains of E. coli are listed. This is very important to our members because almost everybody uses E. coli to do genetics experiments. This applies not only to microbiologists but to anybody who's doing anything involving gene cloning. The types of E. coli strains that are used for gene cloning are non-pathogenic; they've been recognized as non-pathogenic for many years, so some statement should go into this bill saying that not all E. coli is level 2.

There's additional concern within the society about the costs to research and delays in research and in hiring students, which may be occasioned by a strict adherence to the terms of the bill, as opposed to the feedback we're getting from the Public Health Agency of Canada. There's a lot of concern that it may be very difficult to employ foreign students and post-docs because it's already hard enough for them to get visas. If we have to go through security clearance for them, there may be issues with that.

There's a lot of concern about the disconnect between the language of the bill and the much more reassuring tone we get from officials of the Public Health Agency of Canada. When they speak at information sessions, they are addressing the issues very well, but all the documents they give to us say this is proposed, it's not fact. We'd like to be reassured that what they're talking about is what's going to happen.

Some of the other questions from our membership relate to: how does this licensing system increase safety and security over the status quo via safety regulations that are used in universities and government labs? The list of microbes on the schedules is presented as species when we as microbiologists realize that it's the strains that are pathogenic. Many members of the species on those lists are non-pathogenic; they don't pose any threat to human health. Of course, with the constant reclassification of micro-organisms, things could be lumped in with another species when in fact they don't pose any threat.

There was a question about whether the licences will be awarded at the level of the institution, the group, or the individual, because the legal definition of person includes all those, and the bill just talks about persons. There was a suggestion it would be more effective to license facilities rather than individual researchers. We don't understand what the conditions for awarding licences to carry out work with pathogens might be, or whether there will be an appeal process if your request for a licence is turned down.

The cost of the licences is not addressed in the bill itself, whether that will be borne by the researchers or by the government. The Public Health Agency preliminary documents suggest there will be no cost, but we'd like to be reassured of that. We don't know how this is going to affect undergraduate education in microbiology laboratories, laboratory space shared between researchers, some of whom are working with pathogens and some of whom aren't. How will custodial staff have access to labs? Will they require security clearance as well? These are on the whole list of questions I'm getting back repeatedly from my membership.

The eligibility for security clearance is a major issue. That could quite easily become a basis for some human rights problems, as we see it. We don't know who the inspectors will be, how they will be trained, and how they will carry out their tasks.

I'd like to draw the committee's attention to the international journal, Science, which on March 6—last Thursday—published a brief article about Bruce Ivins and anthrax. This is the person who is believed to have been responsible for the anthrax attacks in the United States a few years ago. Some of the things said in that article really hit the nail on the head as to the concerns of members of my society. For example, they're suggesting that the security risk assessment in the States is going to take 45 days. We frequently have visiting scientists from other countries who are only spending a month in our lab. We could just never get them in, and maybe it wouldn't be worth going through this process for such a short period.

The security risk assessment in the U.S. has suggested to exclude persons with substance abuse or mental health problems. That seems to be an issue to me. This is the real scary one: being a citizen of a country the U.S. deems a sponsor of terrorism. Now, this could in fact be used against many Canadian citizens who hold dual citizenship and happen to come from one of those types of countries.

The last thing I would like to mention is that there could potentially be a health risk associated with a risk assessment licensing procedure if the delays are too long. If a diagnostic lab, in the face of an emergency like SARS, has to hire additional personnel or is short of personnel and has to have them in place to do the work, and this bureaucracy interferes with that process of hiring, this could actually backfire in terms of public health.

That is all I have to say. Thank you for your attention. I'd be happy to answer any questions in French or English.

[The Chair, Conservative, Joy Smith]

Thank you so much.

We'll now go to Dr. Descoteaux. We look forward to your presentation.

[Dr. Albert Descoteaux, Professor, Institut Armand-Frappier, Institut national de la recherche scientifique]

First, let me thank you for giving me the privilege of coming to share with you the concerns of a number of my colleagues and myself with regard to many aspects of Bill C-11.

I am a professor and researcher at the Institut Armand-Frappier. Most of the research and teaching activities at our institution are in virology and microbiology. I am also deputy director of the Centre de recherche sur les interactions hôte-parasite and I hold a Canada Research Chair in infection and immunity. I have more than 25 years' experience in microbiology research.

My interest in Bill C-11comes initially from the classification of micro-organisms in the previous version of this bill, Bill C-54. In it, the parasite that I work with, the Leishmania parasite, was classified in group 3, a glaring error. It mobilized the research community that works with the Leishmania parasite, because of the potentially disastrous consequences that this could have on our research work. Regrettably, there had been no consultation with the researchers involved on the reclassification of this micro-organism, and a number of others. It seems that it was done in quite an arbitrary way. Of course, I cannot make that assumption, but it seemed to be so.

A number of corrections were made to the classification of micro-organisms and toxins in Bill C-11. But problems remain, as Dr. Hynes has indicated. Let me give some examples. Viral strains, such as VSV, are classified at level 3, whereas several strains are modified for the laboratory and used with animal models to understand how they cause infection. Mycobacterium bovis, the BCG vaccine strain, is classified in level 3 in this bill, yet one third to one half of the world's population has received the BCG vaccine. This vaccine is currently used to treat certain cancers, such as bladder cancer. Imagine doctors having to go to a level 3 facility to treat their bladder cancer patients with BCG injections. It would be absolutely ridiculous. Escherichia coli was also mentioned.

I would also like to mention toxins briefly. People seem to be very afraid of toxins. But a toxin called botulinum is used to treat wrinkles and some spasms; the common name is Botox. In humans, it is not really very dangerous. Another interesting thing about bacterial toxins in research is that molecules of microbial origin target molecules in our cells in very specific ways. So these toxins become essential tools in studying how a cell works. In cancer, in neurology and in immunology, for example, toxins are frequently used to block cell functions. If toxins became impossible to obtain, or extremely difficult to keep, a good deal of research in those areas would have to be abandoned, or would become very difficult.

As for basic research, that is, the kind of research in microbiology and the fight against disease that a number of my colleagues do, and I include myself, we know that it is essential if knowledge is to move forward. It allows us to understand the interactions between microbes and their hosts, including humans, the pathogenic processes and the immune responses that humans generate against these micro-organisms. Knowledge like that is essential in order to develop vaccines, treatments, diagnostic tests, and so on.

The current version of this bill can potentially have negative consequences. What consequences can over-restrictive legislation have on microbiology research? It could mean reducing or abandoning research on some micro-organisms because of the administrative complexities and the lack of adequate infrastructure. For example, if a researcher in an institution is working with a level 1 organism that is now classed as level 2, he no longer has the required infrastructure, which is very expensive. Is he going to continue his research? Where is he going to get the money to upgrade his facility? The same happens with pathogens that move from level 2 to level 3.

Costs go up for the research institutions and for the researchers who are funded by the Canadian Institutes for Health Research, for example.

Who is going to pay for the oversight mechanisms, the permit applications, the administration? It is all very well to impose constraints, though they seem excessive to me, but who is going to pay for them so that the research does not suffer? Let us not forget that most research in health and microbiology in Canada is funded by the federal government. If this bill is passed in its present form, there will be less return for each grant dollar.

It was said earlier that research requires the free exchange of information, knowledge and reagents. By “reagent“, I mean exchanging microbial strains, and I am not alone. if the rules are too strict, it can interfere with researchers' ability to exchange and obtain the reagents they need to pursue their research. How are we going to address those questions? The bill does not really make it clear. Ultimately, it is the fight against infectious diseases that may be affected by this bill because of the influence it has on the potential for research in Canada.

I would also like to talk about the negative impacts of overly restrictive legislation on the training of highly qualified people. By that, I mean the students in our universities and colleges. As director of the doctoral program in virology and immunology at my institution, and as a professor who teaches microbial pathogenesis, this concerns me greatly. It is crucial to ensure that the next generation of microbiologists in Canada is properly trained. That is done by having them work with micro-organisms.

These highly qualified people will be needed in order to staff our hospitals. These are the diagnosticians, the people who take samples, and so on. They are in research institutions, private or governmental. They are in biotechnology and pharmaceuticals. In the food industry, they are in quality control departments; we have heard plenty about contamination problems in that industry. People have to be familiar with micro-organisms. So we have to train people so that, for example, they go into government laboratories or into teaching.

In Quebec, we train laboratory technicians at college level. They have to learn how to recognize and work with micro-organisms. A good microbiologist can tell the strain of a microbe by smelling it. He can see the shape of a colony in a Petri dish. If we do not give them the ability to do that, or if it is too difficult to have practical courses in schools, universities and colleges, it is going to be very difficult to train the next generation of microbiologists.

We must make sure that the legislation does not prevent students and trainees from getting into research laboratories, or prevent them from learning by working with micro-organisms. You do not become an auto mechanic without ever rooting around inside an engine or a transmission. It is the same in microbiology. You have to be able to play with these micro-organisms in order to really get to know them.

The greatest dangers from infectious disease that Canadians are exposed to are likely to be in contaminated water and food, which are, in fact, often used to justify this bill. Think of Walkerton, think of the listeria crisis, and so on. You can also go to a restaurant, eat something suspect and get food poisoning, but a bill like this is not going to prevent that. The problems there are negligence, inadequate maintenance, poor practices in hygiene or cooking. Nosocomial infections, the ones you get in hospital, are associated with hygiene problems, as are outbreaks of C. difficile. We tackle epidemics such as flu, SARS and legionellosis with appropriate public health measures that allow us to limit and isolate the outbreaks. Canadians will not become safer overnight, or be in less danger from infectious diseases, because of restrictive legislation.

In my opinion, this bill cannot be used to pretend that it is preventing this kind of everyday hazard. I will end by saying that the vast majority of microbiological research in Canada requires micro-organisms in containment levels 1 and 2.

Because they pose a very low risk and because it is unlikely that they would be used for bioterrorism, micro-organisms in schedule 2 must, in my opinion, be removed from Bill C-11.

Thank you for your attention.

[The Chair, Conservative, Joy Smith]

Thank you so much for your comments.

We're going to go into the first round of questioning right now. It will be seven minutes per party.

We'll start with Ms. Murray.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Thank you.

Thank you for those detailed and very knowledge-filled presentations.

One thing that I am trying to understand with this legislation is the problem this bill is a solution for. Can you give me a snapshot of the national or international events that would cause us as legislators to say that we need these new rules, that this is a good thing, and that we're dealing with a problem that people agree exists? Can you comment on that?

[The Chair, Conservative, Joy Smith]

Who would like to take on that question?

Professor Hynes, I noticed you looking as though you were anticipating this.

[Dr. Michael Hynes]

I'm not sure if I'm the best qualified person to answer that.

There obviously has been concern about the possibility of micro-organisms being used for bioterrorism. Some of the precedents for that are the suspected use of anthrax and other agents in the Iraq-Iran war. There was the incident of the anthrax attack in the United States through the mail, which allegedly was carried out by a Department of Defense scientist employed by the government, who had passed through security checks to get his position.

There is again a question as to what measures we can really introduce that would prevent something like that. I suppose there is a general sentiment because of things like SARS and Walkerton, that there's concern in the public about microbial infection, which is not necessarily going to be addressed by this act at all.

I think part of the reason the Canadian government wants to address this is that the American government is doing it, and we do have to walk in step with our neighbours on the same continent with whom we share a long border. There is also the concern that small companies and things like that would not necessarily be observing the currently existing biohazard guidelines. They're not obtaining their funds from national research councils like CIHR or NSERC, and therefore they're not subject to the biohazards certification to carry out that research. I think there is a rationale for trying to bring everybody to the same level playing field if they're doing microbiology research, to make sure they're all following the same rules. We respect that in our society.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

So to add to that question, are there any aspects of the scheme that will create a standardization that will actually save your organizations time and effort in setting procedures for handling and storing of biohazards and for training?

[Dr. Albert Descoteaux]

Maybe I can answer that question.

Concerning level 3 and level 4 pathogens, there are already a lot of regulations. I don't think that adding this criminal aspect would help in deterring somebody determined to cause a bioterrorism act.

I think somebody like the person who was responsible for sending anthrax to the member of Congress in the U.S. was a person who knew how to work with anthrax, who had all the security clearances. If somebody becomes crazy, you cannot do anything about that. By making a law even more repressive, you will not be able to solve this problem or address this issue.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Ms. Sarabia, you mentioned that the bill has to strike a balance.

[The Chair, Conservative, Joy Smith]

Can I interrupt for one moment?

I think Dr. Low wanted to make a comment following that--did you, Dr. Low?--just to further answer Ms. Murray's question.

[Dr. Don Low, Medical Director, Public Health Laboratories, Ontario Agency for Health Protection and Promotion]

Yes. Thank you.

It's really critical that we separate biosecurity and biosafety. There is concern about biosecurity so that you know there's control over the pathogens you are working with, and those fall into risk groups 3 and 4. Biosafety is something all of us, as medical microbiologists and technologists and technicians, are trained to do and are inspected and licensed to do. It deals primarily with level 2 or risk group 2 organisms.

I myself am not aware of any event that has occurred that this bill would prevent. I'm not aware of any event that's been published in the literature or of which I have personal knowledge in which a level 2 organism has escaped from a laboratory and caused disease. We have outbreaks with level 2 organisms all the time, but they do not originate in a laboratory. We have to keep biosecurity and biosafety separated in the discussions.

Just to come back to the biosafety issue and these restrictions, remember that many if not most of the laboratories in Canada are in small hospitals and are intermingled with other departments, such as biochemistry and hematology, and technologists are cross-trained, so these kinds of regulation are going to affect not just microbiology but laboratory medicine across the country.

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Do you believe there is a significant risk of harm if the government were to withdraw this bill and consult with provinces and territories as equal partners and with the industry in a way that was considered sufficient, and then reintroduce the bill afterwards? Would there be major risk to the public from a pathway like that?

[Dr. Don Low]

No.

[Dr. Vivek Goel]

The answer is no, because as has already been clearly indicated by the Public Health Agency of Canada, they recognize that they're going to have to take quite a bit of time to do the consultations on the regulations. They won't be able to implement the bill, if it is passed immediately, until they go through that.

From our perspective, it would be far better for them to go through that process and then clarify some of these issues in legislation where possible, and publish the draft regulations as they put the legislation through. I don't think anything harmful would happen in the meantime.

[The Chair, Conservative, Joy Smith]

Okay.

We'll now go to Monsieur Malo.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you very much, Madam Chair.

Before I turn to you, my dear witnesses, I am going to talk to my colleagues. So, first of all, thank you for being here with us today.

Ms. Murray asked the witnesses a clear question and they all gave the same answer. All my colleagues will agree with me that, with the exception of the officials, of course, all the witnesses who have appeared before us were of the same opinion. None of them said anything to the contrary. They are all convinced that this bill contains unanswered questions that significantly affect the way in which they do their work. I feel that we, as members of Parliament, would be misguided if we did not heed the unanimity from the witnesses and react to it in a meaningful way.

That said, I would like to pick up on an aspect of the discussion that I had never heard before. Mr. Goel said that similar legislation had been put in place in the United States and that it put an end to a number of research projects. I found nothing definitive in the notes provided by the Library of Parliament. It would be interesting to find out more about that. When we get comparisons from outside the country, in fact, we generally study them right here at the committee. If you have any more information about the matter, I would like to hear it right now.

[The Chair, Conservative, Joy Smith]

Who'd like to comment on that?

Dr. Goel.

[Dr. Vivek Goel]

I'll be happy to forward the publication to the clerk. There was also an article in the American Journal of Science in 2004, where they reported on the Patriot Act, which has provisions similar to what is in Bill C-11. The Centers for Disease Control estimated--and I don't have the exact figures--the number of labs they expected to be working with a list of pathogens, and only about a third of those labs actually applied for a licence. Many of the universities, including major institutions like MIT and Stanford, rather than choosing to continue those lines of research, just said they would not allow their faculties and graduate students to work in those areas.

So the net result is that the ability of the nation to be prepared and training people who are working with those types of pathogens gets diminished through this.

I would also note that the U.S. legislation primarily applied to level 3 and level 4 pathogens. So they did not have the kinds of restrictions on level 2 pathogens that could be contemplated with this bill. Indeed the impact might be even greater.

The type of study Dr. Singer has proposed, as described to you last week, is precisely what the United States did after that through the Institute of Medicine and the National Academy of Sciences. They had a comprehensive assessment where the Centers for Disease Control, the National Security Agency, and the academic and lab communities were brought together to look at the most effective way to strengthen biosecurity and biosafety. I think that's really where Canada should be headed as well.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you for pointing out to us that, when it comes down to it, all the questions raised by the researchers who have testified here are perhaps due to the fact that the agency did not make use of a preliminary regulatory framework. If you could have participated, helped to draft it, I feel that all these questions might not have come up at all. You would have had the answers well before appearing here today.

Mr. Goel, Mr. Descoteaux, you brought up the question of research being abandoned. Mr. Descoteaux, you even went a little further in suggesting that, in economic terms, each dollar invested would be worth clearly less than it is today.

Can you give us more details about that?