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.