Evidence of meeting #47 for Environment and Sustainable Development in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was pfos.
A recording is available from Parliament.
Noon
Environmental Defence Canada
Thank you for the opportunity to speak again.
It's a complicated bill, so I'll try to move through it quickly. The committee has already heard about the health effects of these three phthalates; they are developmental and reproductive toxins, according to the national toxicology program. We've also heard that it's important that we look at these chemicals together as a class, particularly because BBP and DBP share a breakdown product that itself is toxic. The goal we should have here is to do what we can, given the strength of the scientific evidence, to reduce exposures wherever we can.
I'll go through the bill by product class rather than by chemical class.
In terms of children's products, that aspect of the bill, all three chemicals need to be restricted. The DEHP part is a no-brainer. It's a reproductive and developmental toxin. It's been restricted in children's toys in the European Union since 1999, and now in child care articles as well, like baby-bottle nipples. More importantly, it is declared toxic to human health under the Canadian Environmental Protection Act, and has been since 1994. Canada has done nothing to reduce DEHP exposure since it was declared toxic 13 years ago. There is much less DEHP now in children's toys and products, but we need regulations to keep outlying companies from selling a teether in Canada that could harm a child.
In terms of BBP and DBP in children's products, they have also been banned in toys since 1999 in Europe, and that ban was extended in 2005. The presence of these phthalates has also been reduced in children's products since then. There is nothing that should keep us from passing that part of the bill.
The argument you'll likely hear is that BBP and DBP are not toxic under the Canadian Environmental Protection Act. There are three problems with this argument. The first is that if you look back at the risk assessments from BBP and DBP, they did not take into account exposure from children's products and exposure from household products. They didn't take into account exposure from breast milk, house dust, or cosmetics in terms of deciding whether BBP and DBP were a risk to human populations. As well, there was no combined assessment. We know that there is a shared breakdown product between the two chemicals and that both of them work in the same way--they both block testosterone. Yet there was no cumulative or combined assessment of the two to decide whether they were causing the problem.
Finally, even if you decide that you can't do this or you don't want to do this under the Canadian Environmental Protection Act, you can easily do it under the Hazardous Products Act, as it already restricts other non-CEPA-toxic substances in toys.
In terms of cosmetics, PollutionWatch supports restricting these chemicals in cosmetics using the Canadian Environmental Protection Act. There is, however, another approach, and that's to use the cosmetics hot list, which is a simple and easy way to prohibit these chemicals. DEHP and DBP, as it says in the bill, should be put on this list. They were both classified in the EU as reproductive toxins as early as 2001, and as of 2003, no reproductive toxins can be used in cosmetics. Most major companies are on their way to eliminating these chemicals, but as we've heard in earlier testimony, they are still present in cosmetics. DBP, in particular, is in nail polishes.
Just as in the argument for children's products that we can't put DBP on the children's hot list because it's not CEPA-toxic, the cosmetics hot list is full of substances that are not toxic under the Canadian Environmental Protection Act. We're talking here about chemicals that are developmental and reproductive toxins and about direct exposure through cosmetics.
Finally, in terms of medical devices, which is perhaps the most important part of the bill, the exposure of infants, children, and the rest of the population to DEHP through medical devices has the potential to be the largest. As a family physician, I am sensitive to the importance of many of these products.
As Ms. Goldman said, I was on the expert advisory group to the Medical Devices Bureau looking at DEHP and medical devices. At the time, we were quite conservative, because we had little information about the alternatives. We were handicapped in how much we could call for substitutions, because we weren't given much information about what kinds of safe alternatives were out there. Still, at the time, the report we put out said that a switch to alternatives was immediately justifiable. In recommendation 4, we urgently encouraged research into the alternatives. I'm dismayed, at this point, to see that since 2002 there has been little research into the alternatives, there's been no education of doctors and nurses in the health care community, and there have been few switches to safer alternatives.
We support this important private member's bill and the part that deals with DEHP and medical devices, with the following caveats. We think there needs to be a phase-out period of three years or so for the health care system to adjust to the removal of DEHP-containing products. We believe that over those three years there should be a safe-substitution consultation in which they work with the health care community to figure out areas in which alternatives do not yet exist on the market, or are not feasible. Finally, we think a procedure needs to be built in so that the government can give three-year exemptions if no reasonable substitutes for products exist.
With these safeguards added, taking action now on DEHP medical devices will be the most important thing this bill can do, and it is an action long overdue.
Thank you.
12:05 p.m.
Conservative
The Chair Conservative Bob Mills
Good; thank you.
I understand, Mr. Glover, you are going to speak on behalf of Health Canada.
12:05 p.m.
Paul Glover Director General, Safe Environments Program, Department of Health
Yes, I will, Mr. Chairman.
Thank you, Mr. Chairman and committee members. It's a pleasure to be here and to have the opportunity to speak to this bill.
As you are aware, Health Canada is responsible for helping Canadians maintain and improve their health while respecting their individual choices and circumstances. We work to prevent and reduce risks to individual health and to the overall environment. We also protect Canadians and facilitate the provision of products vital to their health and well-being.
Our department regulates and approves the use of thousands of products, including medical devices and chemical substances. We do this by being risk-based, and it's important for that to be a critical element as we move forward on this. “Risk-based” means you take a look at both the hazardous profile of a substance and at the exposure, and put those two things together to say whether there is a likelihood harm will result. It is not simply based on the hazardous properties of the substance; it is those properties and the likelihood of exposure that drive the department to act.
Health Canada, to be clear, supports the human health objectives of Bill C-307. However, we do have some concerns with the bill as it is currently written. Please allow me to elaborate.
We've heard a lot this morning about different types of phthalates--BBP, DBP, DEHP. There is a range of phthalates. Three of these phthalates mentioned in the bill have received government action since early in the 1990s. The risks posed by these substances to human health and to the environment were formally assessed under CEPA.
The assessments for BBP and DBP were published in 1994 and in 2000 respectively. Both of those were found not to be CEPA-toxic, and therefore no further action was required under CEPA. That was primarily on the basis of exposure, or the lack of it. DEHP, as you've heard, was found to meet the criteria of CEPA-toxic and was added to schedule 1 of CEPA, giving the government the authority to take regulatory action if necessary.
In addition to the CEPA risk assessments that I mentioned, actions were taken to address risks to human health posed by DEHP in products that pose the greatest risks of health based on the exposure to children. In 1998, based on a risk assessment, Health Canada issued a public advisory on soft PVC toys and child care products containing another type of phthalate, DINP, for which there was a demonstrated health risk through prolonged daily mouthing by children under three years of age--so it was in products designed to go into children's mouths. Canadian industry was requested to immediately stop the sale and production of products containing DINP.
In anticipation of a similar request on DEHP, Canadian industry voluntarily removed DEHP from use in production of children's products likely to be mouthed or chewed, such as soothers and teethers. In essence, we took action on DINP; the industry saw the writing coming and, ahead of us, took voluntary action to remove DEHP at the same time. Although this is a voluntary agreement, Health Canada has evidence that indicates the agreement is working. A 2007 Health Canada survey of child care and other products likely to be mouthed by children under three years of age supports this conclusion. Based on 52 samples collected in 14 different retail outlets, the study did not find any phthalates in child care products intended for mouthing, such as pacifiers and teethers.
We can turn now to the issue of medical devices containing DEHP. Health Canada is very cognizant of this issue. You have heard about the expert panel; in 2003 Health Canada posted on its website a draft position paper for medical devices containing DEHP that included the expert advisory committee's recommendations to develop clinical practice guidelines. This position paper is currently being finalized and will be promoted to the medical community this year.
Next we can turn to cosmetics. They are regulated under the cosmetics regulations made under the Food and Drugs Act, which prohibit the sale of cosmetics that may contain any substance that may cause any risk to the health of the users when the cosmetic is used. The cosmetics regulations require that cosmetics be notified to Health Canada with a list of ingredients and their concentrations within ten days of a cosmetic's sale in Canada.
Neither DBP nor DEHP is found on the cosmetic ingredient hotlist, which you heard of earlier. It doesn't, by the way, require a CEPA assessment, but it does require an assessment to go on the Health Canada list of substances; they're not on that hotlist.
Neither DBP nor DEHP has been found in cosmetics products notified to Health Canada in the work that we have done.
Health Canada believes there is merit to take additional measures to predict the risks of phthalates to the health of Canadians, especially young children, but Bill C-307 is problematic as currently written. Our specific concerns include the following.
DEHP is already on schedule 1 of CEPA, so such an action is not necessary.
Second, given that DBP and BBP were assessed and found not CEPA-toxic, deciding now to add them to schedule 1 without the benefit of reassessment would be problematic and would disregard the evidence-based processes under CEPA. In essence, we have to go back and reassess those before the ministers could approach the Governor in Council to say that there has been a change.
Third, we are concerned with the way the bill is currently written that Bill C-307 may contravene Canada's international trade obligations by imposing technical regulations on imported products without supporting scientific evidence—that is, we have old risk assessments that, if not updated, could create legal concerns for us.
Fourth, with respect to the prohibition of DEHP in medical devices except blood bags, it should be noted that none of Canada's major trading partners, including the United States and the European Union, have prohibited DEHP in medical devices. In the case of the European Union, the European Parliament has urged national governments to restrict the use of DEHP in medical devices for vulnerable groups, except where such restrictions would have a negative impact on medical treatments.
Five, we also have no long-term safety data on the alternative chemicals used for medical devices. It is important to note that some phthalate-free medical devices have not yet been tested for all of the same indications of use as if they had phthalates in them. Therefore, it may not be suitable to simply substitute these out. We would need to assess them further. The bill as written could mean that Canadians might not have access to life-saving medical devices in that case.
Finally, Bill C-307 would use CEPA to control phthalates in products. While that's possible, CEPA may not be the most effective federal act to manage the risks posed by the phthalates in question. Cosmetics are regulated under the Food and Drugs Act; consumer products, including products for children, fall under the Hazardous Products Act.
So as I said from the outset, we do support the human health aspects of this bill, but we feel that, as currently written, there are a number of problems.
We thank you for the opportunity.
12:10 p.m.
Liberal
Geoff Regan Liberal Halifax West, NS
Thank you, Mr. Chairman.
My first question is about kinds of products. We've heard about some of the products that involve phthalates, but I've heard previously that in fact phthalates can leak from such things as soft pop bottles. I haven't heard that today. Have we heard today the limit of what these particular phthalates are in? Am I wrong about the pop bottles, and should we be concerned about pop bottles?
I guess I'll start off with perhaps Dr. Goldman or whoever would like to answer.
12:10 p.m.
Canadian Blood Services / Héma-Québec
I don't distribute pop bottles, only blood, so I will refrain.
12:10 p.m.
Liberal
Geoff Regan Liberal Halifax West, NS
Maybe I could ask, who can answer this question for me, if anyone?
12:10 p.m.
Executive Director, Commonweal
I've seen soft PVC used for some large water containers. I've seen it sometimes used for shampoo bottles. I've seen it used for food storage containers, but I've never turned over a drinking bottle and seen that on the bottle.
12:10 p.m.
Liberal
Geoff Regan Liberal Halifax West, NS
I guess the question is that I heard we should be very concerned about all the plastic storage containers, about pop bottles that are plastic. Is that not the case?
Dr. Khatter.
12:10 p.m.
Environmental Defence Canada
It's a complicated question, only because there are so many types of plastics. There's what we call the plastics pyramid, where polyvinyl chloride—PVC—and polycarbonate plastics are considered the worst ones. So if you're seeing a three or a seven, that's where you're worried about chemicals. The seven is the polycarbonates that have bisphenol A, and the PVC tends to have phthalates such as DHP. There's less concern at the moment about ones and twos that you might find on a pop bottle.
12:15 p.m.
Liberal
Geoff Regan Liberal Halifax West, NS
Dr. Khatter, and perhaps also the other witnesses, you've heard the concerns from the Department of Health about this bill. What's your reaction to that?
March 20th, 2007 / 12:15 p.m.
Environmental Defence Canada
I'm trying to remember all the different parts of it.
I think we understand, to take the last thing first, the idea that there isn't enough testing and alternatives. We are recommending that there be a process to look at alternatives in terms of where there are safe substitutions.
There are two kinds of alternatives, in a way. One is other PVC that has other softeners in it, and there may be some of those softeners that haven't been well tested. But we know there are other products that are made from polypropylene or from nylon where Health Canada itself has not expressed any concern that there's any leaching or any problems. We know there are substitutes out there that we are fairly comfortable are safe.
12:15 p.m.
Conservative
12:15 p.m.
Director General, Safe Environments Program, Department of Health
To respond very directly to the question about pop bottles, our current evidence is that, no, it is not the case. Phthalates are used in a range of substances.
On our test of products, though, we have concerns that we intend to act on with respect to children's toys that are not intended for the mouth, but which we know are being put in mouths. A rubber ducky isn't meant to go in kids' mouths, but they put it there, and that sort of thing. We are seeing some evidence of phthalates being used. We intend to take action to close that loophole.
12:15 p.m.
Liberal
Geoff Regan Liberal Halifax West, NS
To follow up on that, if I may, if people go to a store to buy plastic containers for food, should they be concerned about phthalates being in them today?
12:15 p.m.
Director General, Safe Environments Program, Department of Health
Again, it's a very broad question. I think it's been answered that you can turn it over and look at the number on the bottom. In terms of your specific question on pop bottles, from the evidence we have today, the answer is no.
12:15 p.m.
Executive Director, Commonweal
It's still a fair question. Should we have to memorize the numbers we have to be worried about and turn over the food container? Given that we have other plastics that don't need phthalates, shouldn't all food containers be phthalate free?
12:15 p.m.
Liberal
Geoff Regan Liberal Halifax West, NS
My impression from what you're saying is that it doesn't need to have phthalates to be somewhat soft and flexible and therefore more durable.
12:15 p.m.
Executive Director, Commonweal
Milk-bottle plastic has no phthalates in it, and it's nice and soft. Tupperware has no phthalates in it, and it never did.
12:15 p.m.
Executive Director, Commonweal
While we're worried about things like blood bags or other priority medical devices that we don't have an alternative for, why don't we look at the low-hanging fruit, like food containers or nail polish, where we know how to make them without phthalates?