Health Committee on March 31st, 2009

[The Chair, Conservative, Joy Smith]

Dr. Bennett.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I just wondered if the officials would clarify this. There was some concern from the Canadian society of medical laboratories about diagnostic blood tests and the reality of universal precautions and whether or not you feel this is something that can be dealt with appropriately in the regulations. I guess I was concerned. I thought I had heard they were excluded from this, but I just wonder if you would tell us how you're handling that.

[Dr. Theresa Tam]

We have spoken to the association itself and clarified with them that there are two provisions in the bill in terms of exclusions that would apply.

When people talk about universal precautions, etc., they're talking about protection for the worker and how to handle the taking of a blood sample from a potentially infected individual. What we have here is an exemption under clause 4 in terms of a pathogen occurring in its natural environment. So for someone who is infected, or whose blood is infected, that blood sample is considered a natural environment.

Further, in clause 37, there is an exemption for the people collecting the specimens. If you're just collecting the specimens for the purpose of diagnostic purposes, you're not taking out the pathogen to multiply and manipulate it as you would in a lab. To us, that was clear. That explanation was provided, and the association or society was content with that explanation.

We know there are many variations upon some of those questions, and again, we can also, in the regulation as it is set out, provide very specific exemptions for certain circumstances as these arise.

[The Chair, Conservative, Joy Smith]

Thank you.

Mr. Malo.

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

Thank you, Madam Chair.

I have a question, further to the one put to you by the parliamentary secretary. Would the regulatory framework be more flexible in the case of risk group 2 micro-organisms than the two criteria listed in paragraph (c) of the NDP amendment? How can a regulatory framework offer more flexibility that a provision calling for the location, name of the substance and name of the resource person to be listed and a document attesting to compliance with the guidelines to be signed?

[The Chair, Conservative, Joy Smith]

Dr. Tam, would you like to respond?

[Dr. Theresa Tam]

The regulatory framework document, as was tabled, looks at risk group 2 in some detail in areas where we believe a less stringent application is appropriate, and that doesn't just deal with the location of a laboratory. It deals with a number of areas, including what our intent is for security clearance; the importation, transfer, and exportation of specimens; and other aspects that will be included in the scope of that licence, which we do not see detailed here. Those types of details are really best handled in the regulations themselves.

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

So then, it isn't true to say that the regulatory framework would be more flexible for users of risk group 2 micro-organisms than would be Ms. Wasylycia-Leis' proposed amendment.

[Jane Allain]

The principle that Dr. Tam was attempting to convey was that if you include something in a statutory provision, then it becomes law and essentially cannot be modified. That would be the case with respect to limiting the responsibilities of persons using risk group 2 pathogens and the Laboratory Biosafety Guidelines.

The consultations that Dr. Tam and her colleagues are seeking on the guidelines would reveal how stakeholders and persons subject to this act feel about its provisions. The consultation process would also be helpful in terms of developing a program that would meet both Dr. Tam's need to ensure the biosafety of human pathogens and the needs of researchers who work with these substances.

However, if you include this in the act, there is no flexibility. The main point is that regulations allow for greater flexibility.

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

When you talk about flexibility, you mean for Agency officials, not for the user.

[Jane Allain]

No, I'm talking about flexibility to address the concerns of researchers. It would be an opportunity to discuss matters with them.

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

You maintain that a regulatory framework would provide more flexibility that the option of simply requesting information about the location of the place where the activity is being conducted, the name of the micro-organisms and a signed document certifying that everything is in accordance with the guidelines.

[Jane Allain]

The guidelines pertain to risk groups 2, 3 and 4. It would be a matter of determining which elements and guidelines would apply in the case of risk group 2 pathogens. That is where the flexibility comes into play. As the legislation is now worded, all guidelines would apply.

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

The guidelines that the Agency would like to apply would provide for greater flexibility than the elements set out in subparagraph (ii) of Ms. Wasylycia-Leis' proposed amendment.

[Jane Allain]

This would allow for amending the regulations to take into account some of the more relevant elements of the guidelines having to do with risk group 2 substances.

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

So then, there are certain aspects of the biosafety guidelines that the Agency does not want to see applied to risk group 2 pathogens. Is that correct?

[Jane Allain]

No.

[The Chair, Conservative, Joy Smith]

I would like to take this to the committee now.

All in favour?

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

Madam Chair, I'm asking some questions in an effort to understand the amendment,

[The Chair, Conservative, Joy Smith]

Monsieur Malo, I think we've covered everything.

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

I'm sorry, Madam Chair, but it's still not clear to me.

[The Chair, Conservative, Joy Smith]

Committee members, is there anybody here who is unclear so far about what's going on? Is there anything we've missed?

[Carolyn Bennett, Liberal, St. Paul's, ON]

The amendment is about to be killed.

[The Chair, Conservative, Joy Smith]

Go ahead, Monsieur Malo. You can talk for another hour. Go right ahead.

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

That is not what I'm trying to do, Madam Chair. I'm simply trying to wrap my head around this issue. The word “flexibility“ has been mentioned and I'm hearing that the guidelines in the regulations will provide for more flexibility that the elements set out in subparagraph (c)(ii) where mention is made of “a signed document certifying that the activity is conducted in accordance with the Laboratory Biosafety Guidelines“.

If I go by what Ms. Alain is saying, I have to conclude that the laboratory biosafety guidelines are too stringent regarding risk group 2 pathogens. My understanding is that in the case of risk group 2 pathogens, these guidelines will not be applied in the same way as they are for risk group 3 and 4 substances. Am I correct?