Health Committee on March 12th, 2009

[The Chair, Conservative, Joy Smith]

Good afternoon, everybody.

I would like to welcome our guests to our committee. It's indeed a pleasure to have you.

Today we have our witnesses from the University of Toronto, Dr. Ghalami, senior biosafety officer for environmental health and safety. Welcome. We have Wayne Conlan, principal research officer, as well.

From the Public Health Agency of Canada, at the second round, we have Dr. Butler-Jones and Dr. Tam.

This round is going to go from 3:30 to 4:30, so we're right on time. I would ask that each organization give a ten-minute presentation. We're looking forward to your presentations.

Dr. Ghalami, would you like to start first?

[Ayoob Ghalami, Senior Biosafety Officer, Environmental Health and Safety, University of Toronto]

Honourable members, first of all I would like to mention I do not have a PhD; I am not a doctor.

My name is Ayoob Ghalami. I am the senior biosafety officer for the University of Toronto, speaking as an individual today. Thank you for the opportunity to come and talk on Bill C-11. I think it is a fantastic bill. I fully support it, for reasons I will explain.

As a biosafety officer, my job is on a small scale of what the Public Health Agency of Canada does. I look after 250 labs and three campuses at the University of Toronto. I look after animal facilities that deal with biologicals and I also deal with clinical settings that are set within our university-controlled premises.

I think I would be terrified if I were in public health and got supervision of a lab where I don't know what they have, what they deal with, and where they have it. The burden will be on my shoulders to go and deal with it tomorrow if anything goes wrong. How do I do resource management? How do I do proactive means to make sure individuals are trained? And how do I deal with emergencies?

It's really hard to do proper risk management and risk assessment when you do not know the calibre of the stuff you have to deal with. On the other hand, as we all know, we are in a society of licences and permits. You can't drive if you don't have a valid driver's licence. You can't get married if you don't have a valid licence. You can't open a restaurant if you don't have the proper permits to open a restaurant. However, it seems we are all fine if someone doesn't have a valid licence or permit to deal with biologicals that have and could have the possibility of having an enormous impact on our community. That terrifies me.

On one hand, as an institution what we have decided to do is.... I think this bill would level the playing field for everyone. Currently if I have a principal investigator who imported the biological agent, they're under binding contract with the Public Health Agency of Canada to follow their guidelines. But if another lab gets the same bug from a hospital they have no obligation to do anything. As an institution we don't see that visible practical, so we treat everyone the same. Another reason for that is the memorandum of understanding, which as a public institution we have signed by tri-council government granting agencies, provides the university with the financial means to do research. So that is how we practise that.

I would also like to mention to honourable members that I am a father of two. I have an eight-year-old and a seven-year-old. I really think I have to build a legacy for us to do the right thing so our kids have a safer and a better work environment than we had. I think that's the least we can give our kids.

So far I am 100% for the bill and I see it hands-on in the field. I run the biosafety program for the biggest university in the country and I think we have an established program. Having said that, we in the university try to do our best. We have established a biosafety committee that has 14 faculty members. We have a virologist, a prion specialist, a microbiologist, we have a vice-dean of medicine who sits on that panel, 14 faculty members. We have an occupational health doctor, two veterinarians, me, and three other senior administrators on this panel to decide on everything. We have mandatory training. Whoever works with biological has to be fully trained. Even if they're faculty members, they have to write a test so we understand they know their obligations. We have mandatory medical surveillance. What that means is if you work with human blood, you will possibly be exposed to hepatitis C and you have to be immunized before you do that. And we also have planned post-exposure prophylaxis for you so if you splash your ocular membrane with blood you can go to the hospital and get treated, because if you've got HIV in your system you have to be treated very quickly; time is of the essence. These are what we have achieved as an institution. But if there are no guidelines, these aren't following the guidelines.

For that reason, I really feel and hope members see it that I as an individual, a citizen, feel how important it is for us to have it. When you send your young kid to a university, hospital, or workplace, you really want to make sure all those proactive actions have been taken, so they're in safe hands.

These were the positive things I had to say about the bill. Now I'll come to the other side.

Biological agents are extremely fluid. To put it simply, we have researchers who work with HIV, which is an anti-virus; they use it as a viral vector, so they use it for gene therapy. The anti-virus can infect dividing and non-dividing cells, but it has a narrow host range. What they do is they take HIV, change the membrane to make sure the host range is broader. So now the target cells it can infect are not just one cell; it can infect anything. On top of that, sometimes they put an oncogene, a cancer-causing gene, inside it to infect. How do you do a risk assessment on that? How do you put it in a schedule? This is not fluid. Schedules are there, fixed, done. This changes all the time.

We want to make sure the bill meets the needs of industry. We change all the time. To put in a solid schedule without input or without routine change is not going to help us. I think there has to be a provision on that.

We, as the University of Toronto, have met with the Public Health Agency of Canada in Toronto and we have mentioned it, and they have agreed there will be some changes, or at least there will be input from experts in the field when they change the category.

The second thing we have confirmation on and that will be cited is the security clearance. I think it's extremely important that we have a secure country. I am not a sportsman. I don't think I needed to say that—my physical looks show it—but the reality is that if you're not a good soccer player you'll run after every single ball and you'll exhaust yourself. When it comes to the time you're going to go score, you don't have the energy and means.

As an institution they decided, and I as a biosafety officer feel that—and I think public health has agreed—risk group two should be exempt from security clearance and all the other stuff. At the same time, public health should have full authority to go to check the institutions for risk group two. Listeria is risk group two. E. coli is risk group two. Varicella is risk group two. It's extremely important that they do have supervision, and there is a model existent out there already.

The Canadian Nuclear Safety Commissioner gives the institution as a whole a permit, so you have a permit to function and they know what you have. At any given time they have the right to come and audit your operation to see what you're in compliance with and what you're not in compliance with. At the same time, you don't have to get a permit to buy anything that you want to buy at any given time. If we get that model for risk group two and have as much control as Bill C-11 says for risk group three, most institutions would be able to function and we would leave a good legacy for our kids, because they would be in better hands than we are.

I thank you for your time, and I welcome questions when my turn comes.

[The Chair, Conservative, Joy Smith]

Thank you so much.

Now we'll hear from Mr. Wayne Conlan.

[Dr. Wayne Conlan, Principal Research Officer, National Research Council, As an Individual]

My name is Wayne Conlan. I'm a research scientist with the National Research Council, but I am appearing today as an individual. I'm a microbiologist with 27 years' experience working in level two and level three containment labs in the United Kingdom, the United States, and Canada.

I was a member of the committee that compiled the current Health Canada laboratory biosafety guidelines. Currently, I run a small-animal level three biocontainment facility at the NRC with a focus on highly virulent biodefence pathogens that cause life-threatening infections when inhaled.

I've been the responsible official for the design and implementation of all the biocontainment, biosafety, and biosecurity policies associated with this facility and for training staff in all these areas. And the requisite paperwork occupies more of my file space than all my other activities combined.

Annually, for the past ten years, my facility has been certified for its purpose by the Public Health Agency of Canada and the Canadian Food Inspection Agency. I receive significant funding for this work from the U.S. National Institutes of Health, and therefore my lab must also comply with the U.S. select agent rule, on which Bill C-11 appears to be partially modelled. Consequently, our level three containment facility has been inspected by representatives from the U.S. Centers for Disease Control and Prevention, most recently in October 2008, to ensure that it is operating in conditions equivalent to those required by the select agent rule.

In complying with the select agent rule, our laboratory is already fully operating within the limits being proposed by Bill C-11. For instance, all of our staff with access to our level three biocontainment facility have secret level clearance. Likewise, we already quantitatively update our pathogen inventories every three months. So I don't anticipate that compliance with Bill C-11 will impose any undue additional hardship on the operations of current level three containment facilities in Canada.

It needs to be remembered, in this regard, that many thousands of U.S. researchers are having to comply with the select agent rule, since their federal funding depends on it.

Interestingly, the revelation that the anthrax attack conducted by the U.S. Postal Service was an inside job now calls for even greater restrictions on the U.S. research community, including recommendations that staff with access to select agents undergo mandatory psychological screening. But given the innate eccentricity of many scientists, this could lead to the complete dismantling of the entire U.S. research enterprise in this area. So I hope we choose not to go down this road in Canada.

For the Canadian research community, it's the proposed oversight of level two labs that seems to be the most contentious issue. To date, this has been exclusively managed by the host institutions themselves. However, all such labs ought to be complying with the current biosafety guidelines and should therefore be readily able to comply with the provisions of Bill C-11.

In this regard, prior to the anthrax attack, the worst deliberate case of bioterrorism in the U.S. involved a religious cult contaminating several restaurant salad bars with a level two salmonella species, causing over 700 cases of food poisoning. Indeed, under normal circumstances, level two pathogens kill far more Canadians than level three pathogens. So there is a realistic argument to be made for more formal regulation of these organisms. I guess, on the other hand, it could be argued that level two pathogens are so ubiquitous in our everyday lives that they deserve no special consideration simply because they're being used in research. An analogy with this can be drawn between laboratory rodents, the use of which in research is highly regulated, and wild rodents, which anybody is allowed to kill by any means.

Overall, given the level of compliance being sought by Bill C-11 with respect to level two pathogens, it is difficult to argue against their inclusion in the act. However, level two labs are far more numerous than level three and four labs, and the system for regulating these could be overwhelmed if all these facilities try to register at once to comply with the act. It is incumbent on the Public Health Agency of Canada to ensure that the process of online registration of level two labs is an essentially painless experience that does not delay research progress. Allowing organizations to register all their level two labs in a single application should help in this regard.

There are a few issues obviously addressed by the act on which clarification would be helpful for assessing likely impacts of the act on the research community. For example, many labs use crippled strains of risk group two and three pathogens that are completely harmless, but it's not clear that these will be exempted from the act.

Additionally, many labs not involved in pathogen research use certain toxins in small quantities. A lot of immunologists use cholera toxin or enterotoxin in their immunology research as vaccine adjuvants, for example. Will these labs need to register? My own belief is that they should be allowed to possess a threshold limit of such toxins before being expected to register their facilities.

I thank you for your time. I am willing to answer any questions you might have.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Conlan, for your presentation. It was very insightful.

Before we go into the first round of questions at seven minutes per person, I just want to check that it is the will of the committee, as we have some important business that has to be done. I have a motion and a request before us, and I'm going to have to suspend the committee at 5:15. We have bells at 5:30. Is this okay with the committee to proceed in this manner?

We will now be open for questions. Please go ahead, Dr. Duncan.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Good afternoon. Thank you so much for coming and for your comments.

We've been having hearings for the last few days. I think people appreciate the spirit of the bill, and we all want good biosafety and biosecurity, but a number of concerns have come to light.

An example is consultation. Was there consultation? With level two labs, which you both mentioned, will this be very expensive? Will it be onerous? Duplication was a concern, particularly in Ontario and B.C. Privacy was also a concern. There were suggestions that perhaps this should go back to consultation and then be brought back to committee with the regulations.

I'd like to begin by asking whether your organization was consulted in this process. How were they consulted?

[Dr. Wayne Conlan]

I personally was consulted through direct contact through the Public Health Agency of Canada. They just walked me through the whole process.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

What concerns, if any, did you bring forward at that time?

[Dr. Wayne Conlan]

I had a lot of concerns that have probably been raised over the past few days about the level of regulation and how overburdening it might be for the people concerned. The questions I had at that time were largely answered, and the answers largely assuaged my fears.

The spirit of this act isn't that onerous for level two labs. I suppose to somebody who has to deal with all the oversight required for level three, it doesn't seem that particularly hard. Of course I'm not in the situation of the U of T, which may have 250 such facilities to oversee and register.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

[Ayoob Ghalami]

We have been consulted. I think it was in late 2007 that they initially came. Unfortunately, I haven't prepared time schedules and I don't remember. We were also consulted last year and they also came this year. We had three sessions. There was a public session that U of T hosted and a closed-door session with only U of T, at which we had two VPs, a few lawyers, and lots of faculty members. We also hosted one that was for U of T and all other Ontario universities and teaching hospitals. That was closed-door.

They were happy with what was explained. The competency of the individuals who deal with the scientific side of it was not a concern at all. Public health has an extremely good relation with research institutions in regard to the competency of their staff.

The only concern, as I mentioned, was the security clearance for risk group two. If you look around the university, you will see that more than 60% of our staff are from outside. I personally have an Iranian background. I've been in this country for 20 years, but if we go with the George W. Bush definition, I belong to the axis of evil. That puts you in a position to see how much impact it could have on your individual institution. We have people from China and the Middle East, so it enormously impacts risk group two.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Okay. I understand.

[Ayoob Ghalami]

At the same time, I think it's extremely important that you put it for risk group three, because doing nothing is not a choice.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Agreed. Thank you.

Are you satisfied that the government has chosen the most appropriate way to level the playing field?

[Ayoob Ghalami]

Absolutely, because now we have two standards. I have a level three lab that is certified. I won't mention the university, but there was a university that wanted some of my HIV samples, but they didn't have a certified lab. And they're more than welcome to run an uncertified lab, because it's not regulated. We refused to give it to them, but I'm sure they'll be able to find it from any hospital. All it takes is to get a blood sample infected with HIV, bring it in, and propagate it.

Nowadays, technology has advanced so much that you really don't need to do anything if you don't want to import anything. There are always alternatives. I think that will be a playing field for everyone.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Dr. Conlan, do you think it would be useful for the government to establish an advisory group for this, or a blue ribbon panel?

[Dr. Wayne Conlan]

I don't want to add to the bureaucracy surrounding this. But I can see for contentious issues, so long as the panel was made up of bona fide experts that the rest of the community had faith in, then why not? I can't imagine there are too many contentious issues that are going to arise as a consequence of this bill.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

There is duplication. For example, you're at the University of Toronto, you're in Ontario. How will it be to work with duplicate legislation? Do you think it will be changed?

[Ayoob Ghalami]

It's totally different. I'll give you other examples.

Any restaurant gets inspected by the Ministry of Labour because it's a workplace. At the same time, you get health inspectors checking on food quality. I think the Public Health Agency is the ultimate authority, but nowadays technology has changed so much that a regular Ministry of Labour inspector won't be able to comprehend the scope of the research. I'm not offending them by any means—they're really good at what they do—but technology has changed. You need a specialist to understand this stuff. I think this is the second complementary step. I understand, yes, paperwork is not good, but the consequence of not acting is not good either.

If you check the research, you'll see that American public health had statistical data from 1951 to 1996, and they had to study 4,000 cases. Out of those 4,000 cases, 61% were research institutions that got lab-acquired infection. You're the worst offenders, because you get used to your bug all the time, it becomes part of the family. There is no administrative control, there is no engineering control, you're in a research setting. The only thing we have is a second set of eyes to come and look, because you get used to your wrong practices. You need someone to come and correct you so you don't do that, and it's safe again.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

Dr. Conlan, I'll ask you the same question.

[Dr. Wayne Conlan]

I guess it's a political matter. We're not governed by provincial rules and regulations, only by federal regulations.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

But you all know other scientists in the field. How do you think that will impact—

[The Chair, Conservative, Joy Smith]

I'm sorry, we're out of time.

We're going to have to go to Monsieur Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you very much, Madam Chair.

Thank you for coming here today.

I have some questions, Mr. Ghalami. You stated that Bill C-11 was a very sound initiative. All of the witnesses who have testified so far have said that while the spirit of this bill is laudable, some of the details are problematic. For example, many scientists have voiced their concerns over the inclusion of risk group 2 pathogens in the bill. They also maintain that some of the concepts are too restrictive and that implementing some of the bill's measures could prove too costly for the laboratories.

You maintain that everything is fine for now, that your laboratories are safe and that you are doing everything you can to avoid any problems. My understanding of that statement is that the existing guidelines are adequate.

[Ayoob Ghalami]

Yes. What I can say is that the University of Toronto is a public institution. We have signed a memorandum of understanding with the tri-council that gives us funding. All the funds are conditional on the fact that we have to abide by the third edition of the guideline that the Public Health Agency of Canada has in place. So, institution-wide, we do that.

If this bill were to pass tomorrow and there is no security clearance requirement, as we have been promised by the Public Health Agency of Canada, we wouldn't need to do anything differently as an institution. It may not be the case with other private sectors because they don't have to abide by the rules. But for us, we have to meet that in order to get government funding.

So as a biosafety officer, I don't need to do anything differently from what I do currently if the security requirement is left out. And we strongly urge that this get lifted for risk group two, because that will have an enormous financial impact on us.