Environment Committee on April 26th, 2007

[Marian Stanley]

I think you referred to bottle nipples and other nipples. I don't believe they were ever phthalate plasticized vinyl. Silicone is more like mom, and that's why they're used.

[Anthony Rota, Liberal, Nipissing—Timiskaming, ON]

So in children's toys--for example, we talked about the rubber ducky, which is probably one of the basic toys children get when they're younger--now they're banned from there or they have been voluntarily removed from toys that children put in their mouths.

The one statement I'm thinking of, Ms. Stanley, is when you were talking about letting your children or your grandchildren play with the toy. What I heard was that since it's only in limited amounts anyway, it's not as if they're putting it in their mouth and sucking on it and holding it constantly.

There seemed to be a doubt in your mind if a child took a toy, let's say their favourite toy, and kept it in their mouth constantly over a long period of time. All of a sudden that inserted a little bit of doubt in my mind whether you would let your children have that toy that stays in their mouth all the time. Then I started wondering whether it's something we should expose our children to.

[Marian Stanley]

I know that what the Consumer Product Safety Commission said was that a child would have to keep a vinyl article in his or her mouth for greater than, I think, 95 minutes a day to approach any harm. What they then found in their mouthing study with children is that what children did indeed keep in their mouths for the longest time, their favourite, were the silicone pacifiers. So the behaviour studies didn't show that this is what children were doing. That just wasn't the behaviour.

We know also, at least in the U.S., from the Centers for Disease Control, that the level of phthalates used in toys is virtually non-detectable in the human population. I personally do not have a concern. There are other things I'd be worried about.

[Anthony Rota, Liberal, Nipissing—Timiskaming, ON]

Maybe I'm not hearing you correctly. If a child holds—

[The Chair, Conservative, Bob Mills]

Be brief. Your time's up.

[Anthony Rota, Liberal, Nipissing—Timiskaming, ON]

Already? Sorry about that.

I'll ask a very quick question. What I'm hearing is that if a child holds something with phthalimide in it for 95 minutes or more a day, it can be toxic.

[Marian Stanley]

The other thing the Consumer Product Safety Commission did was a worst-case analysis. They said, okay, we know that what children keep the longest in their mouths is the silicone pacifier. Let's make the assumption that it is vinyl and that it is plasticized, and then let's back-calculate to what the exposure would be. And they said that there's still no risk to children. So again, I personally do not have a concern, because of that worst-case analysis.

[The Chair, Conservative, Bob Mills]

We'll go to Mr. Vellacott.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

One of the other witnesses--you in the industry, of course, would be aware of this--B. Braun Medical Inc., which is not able to be here today, supplies DEHP-free medical supplies. They produce them. They manufacture uniquely PVC-free and DEHP-free basic IV tubing containers and IV administration kits, some licensed for sale in Canada. The company apparently was represented at the Health Canada stakeholders' forum on DEHP in medical devices.

I gather that some of those particular devices may not be available in Canada. Also, it should be noted that their products contain alternate plasticizers. I think there was a comment made before that some of these alternate plasticizers have not been fully assessed. Has there been some partial assessment of these alternate plasticizers? What's the difference between being fully assessed and maybe being in some manner assessed?

[Jon Cammack]

Any product that's approved in Canada or in the U.S. or in other regions of the world--again, I talked about the regulatory requirements--has definitely been evaluated if it is approved. The difference between DEHP and most other manufactured chemicals is that there is a tremendous, overwhelming number of studies that have been done on that chemical in cancer studies and reproductive and developmental studies. So there have been many, many more studies done than what would have been done on any other type of plasticizer.

However, again, any product that is on the market has gone through the appropriate amount of testing. B. Braun is certainly not the only company that has DEHP- and PVC-free products. Many companies also offer those types of products where they are appropriate for the clinical applications and where the functional requirements are met.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

So we're saying that if it's on the market, it's had its testing, at least with a certain rigour. Would something along the way kind of give us cause for.... Is there additional testing done at some point when there are concerns raised?

[Jon Cammack]

The type of testing that has raised concerns about DEHP and rodents—

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

No, I'm talking about the alternate plasticizers.

[Jon Cammack]

I'm going to answer the question.

With DEHP, the types of studies that have been done are very long-term studies, in animals, looking at multiple generations. For alternate plasticizers, as an example, those kinds of studies certainly aren't available in the literature. They're not publicly available. So DEHP, in a sense, is held to a little bit different standard in that respect.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

So the other plasticizers have not been around as long. That's why we don't have this—

[Jon Cammack]

They haven't been around as long, and because of the length of time it takes to do those kinds of studies, it's very unlikely they would have been performed.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

Okay.

I have one last question. Do I have a minute or two left?

[The Chair, Conservative, Bob Mills]

Yes.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

One minute.

They also state, getting back specifically to Braun Medical, that they unequivocally support Health Canada's position paper on DEHP in medical devices, including the purpose-labelling requirements. They're not advocating a general ban on DEHP in medical devices, but they would like to see measures taken to ensure the use of DEHP-free medical devices in the most vulnerable populations, as defined by the position paper of Health Canada.

Would you be agreeable to that? Would there be an openness--that might be the word--or an agreement, possibly, at some point to that same position, that DEHP-free medical devices be available, particularly for vulnerable populations as defined by the position paper of Health Canada?

[Jon Cammack]

I'll answer for Baxter, and maybe Stephen can answer for the industry.

My company doesn't make the kinds of products for those very unique, specialized patient populations, like ECMO, where the concern statements by Health Canada were focused. So again, it is in some very unique populations.

But I would say that already, where there are customers who have a specific request or need, or in cases like this where there has been a focus of attention, medical device manufacturers are providing what our customers are asking for. I would only reiterate that it is based on the functional performance and what the clinical application is.

As I understand the bill, there is a lack of science to indicate that there is a need for a general ban or even a general phase-out over time.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

Okay.

Maybe Stephen now...and the others can respond quickly.

[Stephen Dibert]

Our first position relative to the legislation is to remove the reference to medical devices. However, if there's an amendment or wording that would state that devices that have been proven with science to be safe and effective are viable, then they're free to come to the market and go through the rigorous regulatory process that all other devices that come to the market undergo. And those devices from any companies that bring an advantage, or even a perceived advantage to the marketplace, should do well.

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

So there should be no distinctions for vulnerable populations.

[Stephen Dibert]

Pardon me?

[Maurice Vellacott, Conservative, Saskatoon—Wanuskewin, SK]

So no distinctions for vulnerable populations.