Bill C-307 (Historical)

An Act to amend the Criminal Code to prevent health care practitioners from being coerced into taking part in medical procedures that offend the practitioner's religion or belief that human life is inviolable

[Marian Stanley, Manager, Phthalate Esters Panel, American Chemistry Council]

Good morning, Mr. Chair and honourable members. Thank you for the opportunity to testify before this committee.

My name is Marian Stanley. I'm a chemist by training. I'm a senior director at the American Chemistry Council and I've managed the Phthalate Esters Panel, which is a part of that council, for the last 17 years.

The panel represents the major producers of phthalate esters in the United States and North America. Since its inception in 1973, the panel has demonstrated its commitment to the safe use of its products by sponsoring health, safety, and environmental research.

The panel strongly supports the regulation of chemicals based on sound science. Phthalates are among the most well-studied chemicals on the planet and they have been the subject of hundreds of studies in laboratory animals and numerous government-sponsored assessments in Canada, the U.S., the EU, and Japan. These assessments have studied the risks to human health posed by exposure to phthalates.

The phthalate panel firmly believes the weight of scientific evidence demonstrates that the ban on phthalates proposed in Bill C-307 is unnecessary to protect human health. Bill C-307 proposes to ban butyl benzyl phthalate, dibutyl phthalate, and di(2-ethylhexyl) phthalate in products for use by a child in learning or play and in products that are put in the mouth of an infant when used. At the outset, the proposed ban of these three phthlates in children's toys would do little to protect children's health.

Butyl benzyl phthalate is most commonly used in flooring and insulating sealants. Dibutyl phthalate is used primarily in adhesives as a solvent for organic compounds and in nail polish. These are cellulosic plastics, not vinyl. Another way to think of this, think of screwdriver handles: they are also plasticized by dibutyl phthalate, a cellulosic plastic.

DEHP is used primarily in medical devices, as Dr. Cammack described, and in some soft plastic toys, as Ms. Axmith talked about—swim wings, plastic waterslides, but also in things like raincoats, backpacks, flip-flops, and other products children use in their daily life. These are not intended to be placed in the mouth by children and are safe as they're currently used.

In addition, numerous government risk assessments of these three phthalates have demonstrated that exposure to phthalates in toys and children's products generally poses no significant risk to children. Both the U.S. national toxicology program, the Center for the Evaluation of Risks to Human Reproduction, as Dr. Cammack described, and the European Union have performed risk assessments of these three phthalates proposed to be banned by Bill C-307, and these agencies have found no significant risk to children from exposure to these phthalates.

Similar to its being banned in toys, the proposed ban on DEHP in cosmetics would be of little benefit to human health because DEHP is not used in cosmetics. DEHP is a vinyl plasticizer, and, generally, what I put on my face isn't vinyl. As for dibutyl phthalate, exposure levels to dibutyl phthalate from nail polish are extremely low, such that the risks from exposure to DBP are minimal. For example, dibutyl phthalate exposure levels for the thousands of study participants derived from the U.S. Centers for Disease Control and Prevention biomonitoring data show that levels of exposure to dibutyl phthalate are well within the safety limits set by the U.S. Environmental Protection Agency. These levels already incorporate a number of conservative safety margins. Because the animal data is reviewed, the no-effect level is then assessed, and the “up to 10,000 factor of safety” level is already applied, you've got a built-in precautionary system at work in North American regulatory agencies today.

I'd like to make two points. The measured exposures to dibutyl phthalate and the other phthalates are lower than previous estimates. Additionally, for dibutyl phthalate, the EPA has rereviewed the toxicology data and raised the safety factor for dibutyl phthalate threefold. In effect, that means that a woman using nail polish with dibutyl phthalate would have to use five bottles a day and absorb every single molecule of dibutyl phthalate to reach a level that caused no effect in rodents.

The U.S. Food and Drug Administration, which has regulatory authority over cosmetics, studied the CDC's biomonitoring data in 2001 and said it found no reason for consumers to be alarmed at the use of cosmetics containing phthalates. The FDA continues to evaluate available data on phthalates in cosmetics and has not seen any data that led it to take further steps. Moreover, an extensive 2002 review by the cosmetic ingredient review expert panel--this is an FDA-sanctioned independent body of toxicologists and dermatologists that regularly reviews all compounds used in cosmetics and personal care products--found that dibutyl phthalate and other phthalates used in cosmetics were safe as currently used.

Finally, the 2006 EU risk assessment of dibutyl phthalate mentioned above specifically found no concern for consumers using nail polish containing dibutyl phthalate.

The deck that you all have has a page on DEHP in medical devices. I won't go over that, since Dr. Cammack covered it so very thoroughly, but there are some highlights there for you to read at your leisure. On page seven in the deck that I've given you is a table that summarizes the reviews of the three phthalates that are included in Bill C-307. It looks at the reviews that were conducted in Canada, the European Union, and the United States. So this would be a very quick resource for you.

I'd like to conclude by saying that the extensive science shows that bans proposed in Bill C-307 are unnecessary to protect human health. The government-sponsored risk assessments in North America, Japan, and Europe have demonstrated that human exposure to phthalates in consumer products, including toys and cosmetics, is well below any level that has been shown to cause adverse health effects in laboratory animals, and they are well below government-established safety levels.

Consequently, the effect of these bans on phthalates proposed in Bill C-307 would be to place a significant burden on both manufacturers and retailers of phthalate-containing products and on the consumer and medical patients who rely on the performance and convenience made with phthalates, while it would provide no measurable benefits to human health. For this reason, the phthalate esters panel opposes Bill C-307.

Thank you for your time.

[Mark Warawa, Conservative, Langley, BC]

Thank you, Chair.

I'd like to thank Mr. Cullen for his private member's bill. I appreciate his passion for this and to see phthalates removed. It's an admirable goal. We need to strike a balance of what is realistic, but I think heading in this direction is worthy.

The question I have is similar to Mr. Bigras'. In reading through Bill C-307, the exception is that medical devices would be included, other than blood bags. We've heard from the Canadian Blood Services that storage is cut almost in half if we don't have DEHP in the blood bags. Is that correct?

[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.

Criminal Code

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

moved for leave to introduce Bill C-307, An Act to amend the Criminal Code to prevent health care practitioners from being coerced into taking part in medical procedures that offend the practitioner's religion or belief that human life is inviolable.

Mr. Speaker, the bill would prohibit coercion in medical procedures that offend a person's religion or belief that human life is inviolable. The bill seeks to ensure that health care providers will never be forced to participate against their will in procedures such as abortions or acts of euthanasia.

Canada has a long history of recognizing the rights of freedom of religion and of conscience in our country. Yet health care workers and those seeking to be educated for the health care system have often been denied those rights in medical facilities and educational institutions. Some have even been wrongfully dismissed.

The bill would make those conscience rights explicit in law and would safeguard health care workers' fundamental human rights.

(Motions deemed adopted, bill read the first time and printed)