Environment Committee on April 26th, 2007

[The Chair, Conservative, Bob Mills]

Order, please.

If we could get started, I'd like to welcome our guests. We will ask you to give about a ten-minute-or-so presentation, if you could try to keep it to that. Then we'll go around with questions from the members.

We'll begin. We'll go in the order they're printed here. We'll start with Mr. Stephen Dibert, please.

[Stephen Dibert, President, Canada's Medical Device Technology Companies (MEDEC)]

Thank you.

My name is Stephen Dibert. I'm the president and CEO of MEDEC. MEDEC is the national medical device association representing the medical device industry in Canada.

I didn't have a formal submission here for today. I'll just be speaking from some notes. However, I did send in two written letters, one on March 19 and one on April 10, which I assume were circulated.

I'll just go over my background briefly. I've spent my entire career in health care. I have a degree in kinesiology. I was a respiratory therapist for eight years, working in hospitals, and in many cases working with the medical devices that we'll be talking about a little bit later. For the last three and a half years I've been at MEDEC, working with the industry on various issues.

Just quickly on the industry, the medical device industry is a broad industry. It's defined by the Food and Drugs Act here in Canada. It ranges from orthopedics to ophthalmology to cardiac devices, including various hospital products and medical devices and equipment.

The industry is fairly large in Canada. There are 35,000 people who work in the medical device industry in Canada. About 1,500 facilities produce medical devices in Canada. There's a strong Canadian small to medium-sized enterprise base in Canada. We're doing fairly well as an industry.

As MEDEC, the trade association, we have about 100 companies that belong to the association. About one-third of those are those Canadian small and medium-sized enterprises. Again, we look after the needs of our sector through various areas.

I won't be using the entire ten minutes this morning. I'll leave time for the true experts on the science related to the act.

I'm going to begin by saying that MEDEC and our members do support the health objectives of this act. However, we have several concerns. I'll go through those concerns one by one.

The first concern we have is that a ban on phthalates would have a profound effect on patient access to the medical devices and technology that they need, in many cases, to maintain their health and to improve their health. These devices are as simple as oxygen masks and oxygen tubing, IV bags, IV sets, ventilator tubing. These thousands of devices that are used every day in patient care would be severely affected as the act is currently structured.

We're also concerned that the industry would not be able to provide the viable alternatives that would be needed by the patients. They wouldn't be able to do the research, the development, prove the viability, and get the data and the evidence required to bring these new substitutes or alternates to the marketplace.

Our other concerns include the fact that none of Canada's trading partners have banned phthalates relative to medical devices. They have concerns around some of the chemicals that are used, but no one has banned the DEHP that are used in medical devices.

We are concerned about the lack of science, again, on those alternatives. As you're all aware, in our health care system, Health Canada, through the Medical Devices Bureau, which assesses products based on risk, looks at these products for safety and effectiveness, and we're concerned that some of the products wouldn't be able to meet those risk assessments and get to the patients.

The industry is conducting research, and will continue to conduct research, and to look at substitutes and alternatives as they continue. We have one company here with us today, but I've spoken with several others, such as Tyco, Hospira, Becton Dickinson. They continue to do research on looking at alternate products that meet the needs of patients in our health society.

That outlines my major concerns with the act as it's currently worded. I would ask that the committee consider deleting the reference to medical devices in the act so that patients can get access to the much-needed medical devices they require.

That's my presentation. Thank you.

[The Chair, Conservative, Bob Mills]

Thank you very much.

We'll go on to Mr. Jon Cammack, please.

[Jon Cammack, Vice-President, Technology Resources, Baxter Healthcare Corporation]

Thank you.

Good morning. My name is Jon Cammack. I want to thank you for the opportunity to speak this morning.

Like Stephen, I don't have any formal presentation. I didn't send anything to the committee, but I am going to be speaking from notes.

As just some background on myself, I have a PhD in pharmacology and toxicology. I'm a board-certified toxicologist. I've been with Baxter Healthcare for almost 12 years now. For the last eight-plus years I have chaired AdvaMed, which is the sister trade organization to MEDEC in the United States.

I've chaired AdvaMed's toxicology PVC working group. That working group has been very proactive in partnering, especially with regulatory agencies, on the safety of DEHP and PVC. We worked with Health Canada. We worked with the USFDA and the U.S. national toxicology program on a fairly large industry study that looked specifically at the reproductive and developmental effects of DEHP in developing rodents.

One of the things that Steve stressed is very true. The industry has been very proactive on this issue. We have addressed it head-on.

I am going to spend a few minutes just talking about the science on this topic. I would say if there is any take-away message I would want to leave with you, it's that there is no scientific data that exist right now that indicate that DEHP PVC is harming humans in medical applications--none. There is no science that supports that.

There is a lot of science on the effects of DEHP in animals, and especially in rodents, but for many reasons, that's not applicable to DEHP PVC, as it's used in medical therapy. Again, of anything I would like to leave the committee with, that's what it would be.

I do want to start and just say that in terms of medical products, there are very stringent regulatory requirements that define what kinds of safety studies and what kinds of efficacy studies need to be performed on drugs, devices, and biologics. There are very extensive safety toxicology studies.

There is a certain set of guidelines called ISO 10993 for medical devices. There are ICH, International Conference on Harmonisation, guidelines for drugs. There are special guidance documents for other types of medical products.

This is a very heavily regulated industry and we have to meet very high standards in terms of safety. And all the products that are currently on the market in Canada and countries around the world have gone through these testing criteria. Again, there are very specific toxicology and safety testing requirements.

In terms of DEHP and PVC medical products, I would say, honestly, there is an unmatched product history there. There are over 45 years of clinical use and literally one billion to two billion days of chronic exposure in patients using these products. And as I said earlier, there is no scientific evidence that these products are in any way harming patients at all. It's just the opposite: they're necessary and lifesaving therapies.

I would like to draw your attention to a very recent review that the U.S. national toxicology program conducted. They have a special branch of the national toxicology program that focuses on risks to human reproduction. They have spent the last seven to eight years, again, studying the effects of phthalates, and specifically, DEHP.

There was a lot of information and data that the expert panel reviewed. The overall conclusion was that there was no human data that indicated DEHP exposure from medical products during pregnancy, childhood, or adulthood was causing harm.

Several years ago, the United States FDA did a safety assessment on DEHP PVC medical products. The end result was the derivation of a safety threshold for exposure to DEHP. The overall conclusion from that assessment was that there was little to no risk to human safety with the vast majority of medical PVC use.

Some very specific therapies--such as ECMO therapy, which is used when premature babies are having their blood oxygenated--are listed by the FDA as risk categories, but they did not say that those therapies and products used in them were unsafe.

About two years ago there was a follow-up study on young adults who had been exposed to DEHP during ECMO therapy as premature infants. The intent of that study was to look for any potential adverse effects on the reproductive system. In all those patients who were looked at in this follow-up study, there was no evidence of effects on the reproductive system, reproductive organs, or sexual hormones. That was a very pivotal study.

There has been a lot of focus within regulatory agencies around the world on this topic. I mentioned the FDA assessment. In February 2002, Health Canada published their final safety assessment on DEHP PVC medical products. Their overall conclusion was very similar to the assessments of the USFDA, the U.S. national toxicology program, and the special committee that looks at reproductive effects in humans.

Like the FDA, they also identified special risk categories like ECMO therapy used for premature infants. The FDA safety assessment and the Health Canada safety assessment were finalized before this ECMO follow-up study. That again was a key science-based study that looked at this very unique patient population.

There are other countries, and states within the U.S., that have looked at DEHP and PVC. California is one state that is very environmentally conscious. It has focused on this issue for many years. Approximately three years ago there was a California Assembly bill, Bill 1139, the Lowenthal bill, that called for a ban of DEHP PVC medical products. That bill was absolutely voted down.

The International Agency for Research on Cancer, which is part of the World Health Organization, downgraded the status of DEHP as a chemical that could potentially cause cancer in humans, because of the science. It showed that the way DEHP caused effects in rodents was not able to happen in humans because of the genetic machinery of primates and humans. There were other reasons why they downgraded DEHP, but again they were very science-based.

In Europe, many national European ministries of health have followed that, like the International Agency for Research on Cancer. The Swedish National Board of Health and Welfare is a notable example. It's another very environmentally conscious agency that has downgraded DEHP as a possible human carcinogen, because of the science.

That's a very brief background on the science. There is a tremendous volume of data here.

All that having been said, vinyl DEHP is safe and effective for many medical applications; however, it's not functionally the right material for every medical product application. The industry, including Baxter, has been very proactive for many years in introducing alternative materials. It hasn't been reactive; it has been proactive in the sense of finding the right materials for very unique and specific applications.

The claim made that non-PVC products are safer than PVC products is just not correct. All medical product materials are held to the same regulatory standards. Health Canada doesn't look at a PVC medical product any differently than it does a non-PVC product. It's the same for agencies world-wide. The same standards are applied.

Scientifically it's unclear why there is still a focus here, in light of all the national and international reviews, and especially in the sense that alternative materials are constantly evolving in the industry. Where there are unique functional requirements, those products have been introduced. It's a matter of looking at the right material for whatever the unique clinical application is.

In conclusion, medical products are held to safe and effective standards. Medical applications of PVC and vinyl are recognized by international and national regulatory agencies around the world. The cumulative body of science absolutely supports the safety of DEHP and PVC medical products, and I would submit that public health is not served by uninformed or reactionary policy decisions.

Thank you.

[The Chair, Conservative, Bob Mills]

Thank you.

Marion Axmith, please.

[Marion Axmith, Director General, Vinyl Council of Canada]

Thank you very much.

Good morning, Mr. Chair and honourable members of the committee.

My name is Marion Axmith. I'm the director general of the Vinyl Council of Canada, which is a council of the Canadian Plastics Industry Association. I've been with CPIA for 24 years and I've worked on the Vinyl Council managing the Vinyl Council for the past 14 years.

Our members include a wide range of companies, from resin producers to additive suppliers, compounders, processors or manufacturers, and recyclers. The Canadian plastics industry is about a $51-billion industry. It employs approximately 150,000 Canadians.

The Vinyl Council members are members of a responsible industry within Canadian society. In 1999 we launched our environment management program to manage and reduce our environmental footprint. The program is a commitment to manufacture vinyl products in a safe and environmentally responsible manner. It is our road map to ensure we protect the environment and health during manufacture, use, recycle, and disposal of our products. We continually improve our performance. We strive for sustainability and we improve our capacity to listen to all our stakeholders.

We are here to speak to you about Bill C-307, which is an act to prohibit the use of three phthalates—BBP, DBP, and DEHP—in certain products. We are here to argue that Bill C-307, in its current form, is not necessary, as it circumvents the existing CEPA process for evaluating the safety of chemicals in Canada.

Incidentally, Canada has one of the best screening processes for chemicals in the world today. As I'm sure you're aware, CEPA has already screened 23,000 chemicals over the past six years or so. They've identified 199 of these for further review, and none of these phthalates, which are the subject of this bill, are on that list. They're not on that list because they have been assessed and they are not substances of concern.

What are phthalates? You've heard Dr. Cammack talk about DEHP, but generally phthalates are a class of compounds used mostly with a plastic called vinyl to make that plastic soft and flexible without compromising the strength of the vinyl. As Dr. Cammack said, DEHP has been used safety in medical devices for almost half a century and it provides many very useful benefits, including flexibility, a resistance to kinking, and the ability to withstand harsh sterilization methods while at the same time remaining very cost-effective.

Of the other two phthalates, BBP is most commonly used in flooring, carpet tile, caulking, and sealants. DBP is actually not used in vinyl at all and it is not found in children's toys. The main use for that one is in adhesives, cosmetics, and mostly nail polish.

On DEHP, Dr. Cammack covered the medical devices side. It is used in some plastic toys, inflatable toys like beach balls or water wings, that sort of toy, but it is not used in toys that are put in the mouth by children.

The product that keeps coming up and keeps getting mentioned is teethers. Most of the teethers made in Canada today are not made from vinyl. They do not have phthalates in them. They're made from silicone. So phthalates used primarily in vinyl are a very important part of our everyday lives.

In the next slide in front of you we've covered most of the benefits of the product, so I'll move directly to page 6.

Industry's perspective is that science should prevail here. We feel it's very important to remove this debate from the political arena and move it to the scientific and medical arena, where it can be properly studied and reviewed. The weight of scientific evidence to date demonstrates that bans on phthalates are unnecessary to protect human health.

As you're aware from your March 20 meeting, Health Canada has expressed concerns about the legislation as it is currently written, and I'd simply like to take you through some quotes that I pulled out of the transcript of that meeting from Mr. Paul Glover, who is the director general of the safe environments program of Health Canada. These are quotes and these are some of the things Mr. Glover said at the March 20 meeting:

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.

...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.

So the Vinyl Council would respectfully like to put on the table two proposed amendments to this bill. The first one occurs in clause 3, to amend that, on page 1 of the bill, by replacing lines 9 and 10 with the following:

the coming into force of this Act in accordance with the Canadian Environmental Protection Act, direct Environment Canada and Health Canada to review the use of the three phthalates: BBP, DVP, DEHP.

The second amendment refers to clause 3 on page 2, by deleting lines 9 and 10, which in effect would delete “medical devices” from the bill.

In summary, I want to stress that the Canadian plastics industry is a very responsible sector. We care deeply about the health and safety of Canadians. The Canadian public is our clientele. Canada has one of the best screening systems in the world for assessing chemicals, and we are asking that CEPA and the CEPA review process be allowed to work. Use this excellent system that the government has put in place.

We cannot make policy based on rumour, innuendo, and fear-mongering. Follow the science, use the excellent CEPA screening system that already exists.

Thank you, Mr. Chair.

[The Chair, Conservative, Bob Mills]

Thank you very much.

We'll go now to Marian Stanley, please.

[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.

[The Chair, Conservative, Bob Mills]

Thank you very much.

We'll begin our first round. Ten minutes.

Mr. McGuinty.

[David McGuinty, Liberal, Ottawa South, ON]

Thanks, Mr. Chair.

Thank you very much for coming, ladies and gentlemen.

We have in front of us here on this bill probably a hundred pages of conflicting testimony and evidence. We had Health Canada come here some weeks ago to speak to us about this bill. I think for most Canadians Health Canada has the referee's role, the broker's role, between industrial interests, health interests, and obviously health care interests, in this case.

It's placing us in a very difficult situation, because while we here in the official opposition support the notion that we ought to examine these chemical compounds, we're not in a situation, I think, to recommend to Canadian health care providers that they ought not to be using products that play an indispensable role in health care or in pandemic preparation.

So please help us understand here. How can this bill be amended so that it actually meets the primary interests of this committee and parliamentarians, which is to put the health of Canadians and the safety of Canadians first? I know it's an emotional issue. In part it has been cast as an emotional issue because the bill has been presented as something that talks about things that go in children's mouths. As a father of four children, I'm concerned about what they put in their mouths. Now, as teenagers particularly, other things go in their mouths.

I'm just trying to get a sense here of how this can be amended so that we achieve what the French would call le juste milieu, the proper balance. We're not out to commit economic hara-kiri with industries in this product business. We want to see health care go forward, but we want to see health and safety here properly reflected. Can you help us understand, what do we have to do to this two-page bill to make it right?

[Jon Cammack]

Marion, I think you had suggestions.

[Marion Axmith]

Mr. McGuinty, as I mentioned in my presentation, I have proposed a couple of amendments to the bill.

Our perspective is that we have a CEPA review process for the review of chemicals, for their risk assessment, and for their risk management. If you, as a committee, have concerns about these substances, refer them back to Health Canada, to Environment Canada, for further assessment. As mentioned, they have already been assessed a number of times.

With regard to Health Canada, Health Canada is, as I'm sure you're aware, the arm of the government that approves the medical devices for use. There is a very stringent screening process for approval of these medical devices, and they have been doing that for decades.

I would just further point out that there is not one documented case of a Canadian being harmed by any of these medical devices. I'll leave it at that.

[David McGuinty, Liberal, Ottawa South, ON]

So your position, then, for Canadians who are watching and following this debate, is that we should go with the recommendations of the referee, and the referee is Health Canada. You're telling us that the referee came here some weeks ago and told us to restate what you've restated for Mr. Glover--that the risk to human health and environment was formally assessed by CEPA in 1994 and 2000, and that these assessments concluded that none of these products were CEPA-toxic on the basis of exposure. You talked about the fact that substitution may not be possible. That's Health Canada's position.

If that's the case, why do I and all committee members here have a half-dozen environmental groups walking into our offices and sending us briefs saying the exact contrary, saying the exact opposite, saying that the science conducted by Health Canada was faulty, saying that it did not take into account cumulative exposure. Who's right? Who's wrong? Who's spinning? Who's helping us come up with actual balanced decisions here?

[Marion Axmith]

I know, Mr. McGuinty, that the industries, whether they are the medical devices industry, the vinyl industry, or the phthalate industry, have done their homework, have participated in studies, and have supported studies over many decades.

With regard to the environmental groups that are raising concerns on these substances, I challenge them to come forward with their scientific data and information to support their allegations.

[Marian Stanley]

Mr. McGuinty, I could give you a brief U.S. perspective. As I said, I've worked with the phthalates panel for 17 years. In the early nineties we were working with Health Canada and getting very comprehensive reviews of the phthalates with Health Canada and Environment Canada.

Now, at the same time, the U.S. had in place review processes, but they were in silos, so we didn't have an agency that put everything together in a comprehensive manner. You've had this for a very long time, and you had that process in place before the European Union even thought about their chemicals program.

Many of the allegations about phthalates and other chemicals are based on hazard and hazard alone. What you need to do in the scientific framework is to look at not only hazard but also exposure. We certainly recently had a case in the U.S. in which a woman was challenged by a radio station to drink water. She died because she drank too much water. In that dose, it was certainly a hazard. In normal everyday doses, water is not, so the risk is low.

We know from measured data now that the exposure to phthalates is very low, certainly well below the level that causes any hazard in animals. We believe also that our current North American regulatory system has a precautionary basis to it, so that human health is well protected.

[David McGuinty, Liberal, Ottawa South, ON]

Let me maybe put this to you, then, for the last comment. I have a brief here from one particular NGO, which states a couple of things:

A 2006 U.S. National Toxicology Program...report confirmed that DEHP “poses a risk to human development and reproduction”...

DEHP, BBP, DBP have been added to the California Proposition 65 list of toxic substances.... [Canada's] assessments...failed to include exposure from consumer products, house dust and breast milk, underestimating children's exposure....

The European Union has banned DEHP, DBP, and BBP in all toys and childcare articles, and DEHP and DBP in cosmetics. Other countries that have banned phthalates in children's toys include Argentina, Fiji, Finland, Japan, and Mexico.

It goes on from there.

Are these people wrong?

[Jon Cammack]

I think that some of the statements you just read were maybe taken out of context. Specifically, the U.S. NTP and the Center for the Evaluation of Risks to Human Reproduction said very conclusively that there is--bottom line--insufficient human data to indicate that there is harm occurring in humans.

It is a raging debate, there's no question about it. From what we have seen directed at the medical products industry, the data we get presented by the environmental groups is based completely on rodent studies that are done in ways that aren't necessarily relevant to how our products are used. By that I mean it may be very, very high doses, for example, of a chemical like DEHP that a rodent is exposed to, and by a route of exposure, very high oral dosing, that may not necessarily be relevant to how a medical therapy interacts with the human body.

I don't think anybody--any scientist or toxicologist--would question that there is very credible rodent data that shows effects of phthalates at very high levels.

[David McGuinty, Liberal, Ottawa South, ON]

May I ask, has the European Union banned DEHP, DBP, and BBP in all toys and child care articles, and did they ban DEHP and DBP in cosmetics? That's 26 nation-states. Have they banned these products?

[Marian Stanley]

I'll speak to that.

First of all, those phthalates were not banned in all toys. They were banned prior to the completion of risk assessments. The ban is in toys that can be placed in the mouth, and it's for a five-centimetre-square piece of article.

There's also another part of the European legislation called the CMR list—carcinogen, mutagen, or reproductive toxicant. It is based solely on hazard. So if you have an effect in any animal, and it's deemed to be a level-one or level-two CMR substance, it goes on a list. There are approximately 1,700 substances on that list currently. But if it's placed on that list, it can't be used in consumer products. Now, the irony of that is that dibutyl phthalate is certainly on the CMR list; however, the risk assessment also says there's no problem with its use in cosmetics by the general population.

For DEHP, it's the same thing; it is hazard-based.

[The Chair, Conservative, Bob Mills]

Thank you, Mr. McGuinty.

Mr. Lussier, please.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

Thank you, Mr. Chairman.

Ms. Stanley, you represent the American Chemistry Council. Are you a chemist?

[Marian Stanley]

Yes.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

Have you ever worked in a laboratory where you were called upon to analyze human blood for the purposes of detecting the chemicals that are under consideration today, that is BBP, DBP and DEHP? Have you ever undertaken a chemical analysis in order to determine the concentration of these chemicals in blood?

[Marian Stanley]

No, my experience as a chemist has been in the chemical industry as an analytical chemist looking primarily at organic compounds. My experience as a chemist has also been within the pharmaceutical industry, working in a laboratory and looking at quality control of pharmaceutical compounds. Additionally, I've done quality assurance in the pharmaceutical industry and have been a technical product manager. I have not worked with blood or urine samples.

[Marcel Lussier, Bloc, Brossard—La Prairie, QC]

Have any of the experts before us undertaken a chemical analysis of human blood in a laboratory, in order to detect the chemicals that we are discussing?

Mr. Cammack?