Health Committee on March 5th, 2009

[The Chair, Conservative, Joy Smith]

Sorry, Mrs. Davidson, your time is up.

Monsieur Dufour.

[Nicolas Dufour, Bloc, Repentigny, QC]

Thank you very much.

Mr. Ouellette's presentation and Mr. Matlashewski's were very interesting. The scientists said that they had not perhaps been consulted on the now-defunct Bill C-54. Instead, they had information sessions.

You heard them. They agree with the idea behind Bill C-11, but they have some concerns with very specific points. I would like you to tell me how you could amend Bill C-11, now that you have heard Mr. Ouellette and Mr. Matlashewski give their side.

[Theresa Tam]

Thank you for the question.

Again, the experts are supporting our concept that we must have really robust consultations on the development of the regulations. We know it would take another two years or so before we can develop the regulations. That's not only because the regulatory process in Canada is very robust. We need them to input into how we're going to design and implement the programs. Without their input we can't draft the regulations. That's very clear to us. This is the beginning of a very meaningful dialogue we hope we're going to have with them.

[James Gilbert]

If I could add to that in terms of specific questions, when we got out there with the legislation there were a lot of questions. The act itself is the shell, and the real details that are of concern to researchers and administrators of the universities are in the regulations and the program design. In terms of the bill itself, only certain elements are going to come into force right away, like the prohibition on smallpox. We think that makes sense. We want to have that prohibited. The rest of it is only going to take force through the regulatory consultations we're going to go ahead with. We're learning a lot by discussions. How we would set up a program around a large university like the University of Toronto with very sophisticated biosafety committees and governance around that is going to be a lot different from how we deal with an individual lab doing some testing in food safety, for instance. There's a cabinet directive that we need to consult on regulations, and of course we'll do that, but to get good programs, to get good regulations, we'd need to because of the complexity of the work.

With the bill itself, after dialogue with stakeholders, we think we've got the right balance in the bill between innovation and safety and security. It's really going to be the regulations that need to take quite a while. The Public Health Agency of Canada is committed to do this robust back and forth dialogue with stakeholders.

[Nicolas Dufour, Bloc, Repentigny, QC]

There was another fear, mostly expressed by Mr. Ouellette, that the inspectors would perhaps have too much power under Bill C-11 and that this could slow their work down. I would like to hear your response to that.

[Theresa Tam]

I believe there was a change between Bill C-54 and Bill C-11 so that the inspectors must have a reasonable belief that whatever is happening in a laboratory pertains to the application of the act or the ensuing regulations.

We have also thought about how to harmonize what might be already in existence in provinces. One of the ideas was to delegate authority, and the bill does allow that. If we trained provincial inspectors already inspecting labs to also have the delegated authority to inspect under the Human Pathogens and Toxins Act, we would be able to leverage each other's capabilities and resources and not duplicate the impact on the laboratories.

[The Chair, Conservative, Joy Smith]

Thank you very much, Dr. Tam.

I will now go to Mr. Uppal. I understand you're sharing your time with Mr. Brown

[Tim Uppal, Conservative, Edmonton—Sherwood Park, AB]

That's right.

[The Chair, Conservative, Joy Smith]

Thank you.

[Tim Uppal, Conservative, Edmonton—Sherwood Park, AB]

Thank you, Madam Chair.

Thank you for coming back.

My question comes from our guests previous to you. They were talking about security screening and how it's going to be bothersome in some ways, especially for students and others visiting. Can you explain why it's needed and why it was put into the bill?

[Theresa Tam]

The bill does deal with biosecurity, and post-9/11 many of our allies moved forward with legislation that dealt with biosecurity. We do not currently have any scheme in Canada that focuses on the need to keep inventories or track who has access to the most dangerous pathogens.

We are proposing in the regulatory framework that the security clearance be commensurate with the risk group of the pathogens. For risk group 2 we are not thinking of requiring security clearance, and that applies to the vast majority of laboratories. There are only about 150 of them left that deal with risk groups 3 and 4.

We are thinking of looking at select risk group 3 agents. For example, working with HIV or TB is not the same as working with anthrax, which is also in risk group 3, or the SARS virus, which has disappeared from our human population but is a risk group 3. Through the development of the regulations, that will also be consulted upon with the stakeholders.

In terms of risk group 4, Dr. Plummer and his next-door neighbour have the only level 4 laboratory in the country, and they already do security screening.

[Tim Uppal, Conservative, Edmonton—Sherwood Park, AB]

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you, Mr. Uppal.

Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you.

It has been mentioned that there haven't really been any serious incidents of bioterrorism in Canada involving human pathogens or toxins. Are there examples you could point to outside of Canada that would highlight the need for this regulatory framework?

[Theresa Tam]

Yes, and I think Canadians remember most the SARS virus, which has now been eliminated from the human population through a global effort.

In Beijing, China, the SARS virus came from infected laboratory workers who infected their family members. So if that type of situation isn't contained, the SARS virus could re-emerge in our population, and nobody wants to repeat that scenario.

That is something that luckily has not happened in Canada. But let me stress that after the elimination of SARS circulation in Canada, there are probably a number of laboratories that host the SARS virus. We would like to know which laboratories these are, but there's no formal, systematic mechanism to find that out. You can do surveys and things, but we have no authority to ask who possesses the SARS virus.

On another example, salmonella is a risk group 2 pathogen, but in Oregon it has been used to spike salad bars. Someone put salmonella in the salad bar, and that is an act of bioterrorism. Another example is the anthrax letters in the United States. But in the former Soviet Union there was a release of anthrax that not only affected lab workers but was distributed in a plume because of the winds, and it infected people outside the laboratory in the community itself.

So many of these agents are in the risk groups 3 and 4. They are the ones we worry about the most, but people can use salmonella, E. coli, or other viruses.

Another thing that people may know about is the polio virus. The polio virus is undergoing eradication. It has been eliminated from the Americas. As part of our responsibility to the World Health Organization--and we signed on to this--we should know where polio viruses are in Canada. Save trying to do some surveys, we have no authority or ability to actually figure this out. So we were not able to complete our reporting to the WHO to the extent we would have liked. We did the best we could, but this bill will allow us to really track who has the polio virus, the SARS virus, etc.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Tam.

We're certainly learning very valuable information today.

Ms. Duncan.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Thank you.

I'm struggling with the fact that we do not know what labs contain levels 3 and 4 viruses today. It is very positive that we will know that.

What about emerging threats or acts of bioterrorism? Are we going far enough with this legislation?

[Theresa Tam]

It again speaks to the more comprehensive, overarching approach we need. A bill or regulation can only go so far in ensuring biosecurity. Security screening provides you with one level of reassurance, if you like, that those who have access to levels 3 and 4 pathogens have at least undergone security screening. Beyond that, there will always be some individuals who do something you never really anticipate.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

What are the possibilities, after the rights have been created, to bring this back to committee?

[Jane Allain, General Counsel, Legal Services, Public Health Agency of Canada]

The regulation-making process, as Dr. Tam alluded to, is a very onerous process with very transparent and meaningful consultations. On the process itself, they go out and consult on their intentions in the regulations, and then they pre-publish the regulations they draft. That is in the Canada Gazette, part I, and there's a consultation period following that.

Based on the feedback and the information they receive, the department goes back and looks at it again from a more critical view and does another full re-write of the regulations themselves before they publish them finally in the Canada Gazette. There's a requirement through that gazetting process to talk about your regulatory impact assessment and describe what you heard from the stakeholders and why you addressed them in a certain way. So all of that is public.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

This is something we talked about on Tuesday. I think we acknowledged that a duplicate system has been created, for example, in Ontario. How will that be addressed?

[Theresa Tam]

To the extent that there are provincial-territorial guidelines, or some provinces and territories have requirements in place, they generally are regarding workplace health and safety or quality assurance related to diagnostic capabilities. They differ from jurisdiction to jurisdiction. Rather than just directing a specific population, such as laboratory workers, the bill is broader—the Canadian public.

There are no comprehensive provincial schemes that address every type of laboratory in a province, such as medical diagnostic versus water testing versus university, etc., and they certainly don't focus on requirements such as keeping inventories or tracking who has access to what.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Dr. Tam, I understand that, but the question is, how are we going to look at...? There is a system of duplication here, so what are we going to do to deal with it?

[Theresa Tam]

In the development of the program implementation and regulations, what we are looking at is areas where we can harmonize. So, for example, if there is an inspection scheme in a province—it may only be directed toward medical diagnostic labs, but if one exists—we would leverage and not duplicate the efforts. As I say, you can have the same inspector reporting, and we may have a more streamlined reporting mechanism so that the lab isn't required to have too many routes of reporting. We could harmonize some of those.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

Is that in the legislation? There's some concern from the universities, for example, and the labs in this area. Could that information be in there and clarified?