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38th PARLIAMENT, 1st SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Monday, April 11, 2005

1535

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Mr. Paul Mayers (Acting Director General, Food Directorate, Health Products and Food Branch, Department of Health)

1540

Ms. Karen L. Dodds (Executive Director, Pest Management Regulatory Agency, Department of Health)

Mr. Paul Mayers

1545

The Chair

Mr. Steven Fletcher (Charleswood—St. James—Assiniboia, CPC)

The Chair

Mr. Rob Merrifield (Yellowhead, CPC)

The Chair

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

Ms. Karen L. Dodds

Ms. Trish MacQuarrie (Director, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health)

Mr. Rob Merrifield

Mr. Paul Mayers

Mr. Rob Merrifield

Mr. Paul Mayers

Mr. Rob Merrifield

Mr. Paul Mayers

1550

Mr. Rob Merrifield

Mr. Paul Mayers

Mr. Rob Merrifield

Mr. Paul Mayers

Mr. Rob Merrifield

Mr. Paul Mayers

Mr. Rob Merrifield

The Chair

Mr. James Lunney (Nanaimo—Alberni, CPC)

Mr. Paul Mayers

Mr. James Lunney

Mr. Paul Mayers

Mr. James Lunney

Mr. Paul Mayers

1555

Mr. James Lunney

Mr. Paul Mayers

Mr. James Lunney

Mr. Paul Mayers

Mr. James Lunney

Mr. Paul Mayers

Mr. James Lunney

Mr. Paul Mayers

Mr. James Lunney

Mr. Paul Mayers

The Chair

Mr. Réal Ménard (Hochelaga, BQ)

Mr. Paul Mayers

Mr. Réal Ménard

Mr. Paul Mayers

1600

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

Ms. Claudette Dalpé

Mr. Réal Ménard

The Chair

Ms. Karen L. Dodds

1605

The Chair

Hon. Robert Thibault (West Nova, Lib.)

Ms. Karen L. Dodds

Hon. Robert Thibault

Ms. Karen L. Dodds

Hon. Robert Thibault

Ms. Karen L. Dodds

1610

Mr. Paul Mayers

The Chair

Ms. Jean Crowder (Nanaimo—Cowichan, NDP)

Ms. Karen L. Dodds

Ms. Jean Crowder

Ms. Karen L. Dodds

Ms. Jean Crowder

Ms. Karen L. Dodds

Ms. Jean Crowder

Ms. Karen L. Dodds

Ms. Jean Crowder

Ms. Karen L. Dodds

Ms. Jean Crowder

Ms. Karen L. Dodds

1615

Ms. Jean Crowder

The Chair

Ms. Karen L. Dodds

The Chair

Mr. Michael Savage (Dartmouth—Cole Harbour, Lib.)

Mr. Paul Mayers

Mr. Michael Savage

Mr. Paul Mayers

Mr. Michael Savage

1620

Mr. Paul Mayers

Mr. Michael Savage

Mr. Paul Mayers

Mr. Michael Savage

The Chair

Ms. Claudette Dalpé

The Chair

Ms. Claudette Dalpé

The Chair

Mr. Paul Mayers

The Chair

Mr. Steven Fletcher

Mr. Paul Mayers

Mr. Steven Fletcher

Mr. Paul Mayers

The Chair

Hon. Brenda Chamberlain (Guelph, Lib.)

1625

Ms. Karen L. Dodds

Hon. Brenda Chamberlain

Ms. Karen L. Dodds

Hon. Brenda Chamberlain

The Chair

Ms. Nicole Demers (Laval, BQ)

Mr. Paul Mayers

1630

Ms. Nicole Demers

Mr. Paul Mayers

The Chair

Mr. Paul Mayers

1635

The Chair

Mr. Paul Mayers

The Chair

Mr. Paul Mayers

The Chair

Mr. Colin Carrie (Oshawa, CPC)

Mr. Paul Mayers

Mr. Colin Carrie

1640

Mr. Paul Mayers

Mr. Colin Carrie

Mr. Paul Mayers

Mr. Colin Carrie

The Chair

Mr. Michael McBane (National Coordinator, Canadian Health Coalition)

1645

1650

1655

The Chair

Mr. David Bennett (National Director, Health, Safety and Environment Department, Canadian Labour Congress)

1700

The Chair

Mr. Shiv Chopra (As an Individual)

The Chair

Mr. Shiv Chopra

1705

The Chair

Mr. Steven Fletcher

The Chair

Mr. Steven Fletcher

Mr. Shiv Chopra

The Chair

Mr. Steven Fletcher

Mr. Shiv Chopra

Mr. Steven Fletcher

Mr. Shiv Chopra

Mr. Steven Fletcher

The Chair

Mr. Steven Fletcher

Mr. Shiv Chopra

1710

Mr. Steven Fletcher

The Chair

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

1715

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Shiv Chopra

Mr. Rob Merrifield

Mr. Michael McBane

Mr. Rob Merrifield

Mr. Michael McBane

Mr. Rob Merrifield

The Chair

Mr. Réal Ménard

Mr. Michael McBane

Mr. Réal Ménard

Mr. Michael McBane

1720

Mr. Réal Ménard

Mr. Shiv Chopra

Mr. Réal Ménard

The Chair

Mr. Shiv Chopra

The Chair

Mr. Michael Savage

Mr. David Bennett

Mr. Michael Savage

Mr. Michael McBane

1725

Mr. Michael Savage

Mr. David Bennett

Mr. Shiv Chopra

Ms. Margaret Haydon (As an Individual)

The Chair

Mr. Steven Fletcher

The Chair

1730

Mr. Steven Fletcher

The Chair

Mr. Steven Fletcher

The Chair

Ms. Jean Crowder

Mr. Michael McBane

1735

Mr. David Bennett

The Chair

Hon. Brenda Chamberlain

Mr. Michael McBane

The Chair

Mr. Michael McBane

1740

The Chair

Mr. Michael McBane

Hon. Brenda Chamberlain

Mr. Michael McBane

Hon. Brenda Chamberlain

Mr. Michael McBane

Hon. Brenda Chamberlain

Mr. Michael McBane

Hon. Brenda Chamberlain

Mr. Michael McBane

Hon. Brenda Chamberlain

Mr. Michael McBane

The Chair

Hon. Brenda Chamberlain

Mr. Michael McBane

Hon. Brenda Chamberlain

Mr. Michael McBane

The Chair

Mr. Shiv Chopra

Hon. Brenda Chamberlain

Mr. Shiv Chopra

The Chair

Mr. Shiv Chopra

Hon. Brenda Chamberlain

Mr. Shiv Chopra

Hon. Brenda Chamberlain

The Chair

Hon. Brenda Chamberlain

The Chair

Hon. Brenda Chamberlain

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

1745

Mr. Shiv Chopra

Mr. James Lunney

Mr. Shiv Chopra

1750

Mr. James Lunney

Mr. Shiv Chopra

Mr. James Lunney

Mr. Shiv Chopra

The Chair

Ms. Nicole Demers

1755

The Chair

Ms. Nicole Demers

The Chair

Ms. Nicole Demers

The Chair

Dr. Gérard Lambert (As an Individual)

The Chair

CANADA

Standing Committee on Health

NUMBER 031

1st SESSION

38th PARLIAMENT

EVIDENCE

Monday, April 11, 2005

[Recorded by Electronic Apparatus]

* * *

¹ (1535)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen.

It's my pleasure to welcome all of you to the 31st meeting of the Standing Committee on Health, when we will be examining Bill C-28, An Act to amend the Food and Drugs Act.

The meeting will be divided into two separate sessions. In the first session we will hear from Health Canada officials: Mr. Paul Mayers, the acting director general of the food directorate; Ms. Dodds, executive director of the Pest Management Regulatory Agency; and Ms. Dalpé, associate director, food regulatory programs and access to information.

I believe Mr. Mayers will begin. The floor is yours, sir.

Mr. Paul Mayers (Acting Director General, Food Directorate, Health Products and Food Branch, Department of Health): Thank you, Madam Chair. It's a pleasure to share with you information on Bill C-28.

Health Canada is recommending that the government move forward with two amendments to the Food and Drugs Act.

[Translation]

The first amendment would provide the Minister of Health with the authority to issue an Interim Marketing Authorization allowing the sale of some food products, for which scientific assessment has established that there is a reasonable certainty that no harm to consumers will result from its consumption, pending completion of the full regulatory process.

[English]

The second amendment would exempt a food containing residues of a pesticide that are at or below the maximum residue limit specified by the Minister of Health under the new Pest Control Products Act from the adulteration provisions of the Food and Drugs Act.

Maximum residue limits are set following a scientific assessment that has established that there is a reasonable certainty that no harm to consumers will result from the consumption of foods containing these residues of pest control products at the maximum limits established.

The proposed amendments in part are in response to concerns raised by the Standing Joint Committee for the Scrutiny of Regulations regarding an administrative process put in place by Health Canada to allow Canadians faster access to safe and nutritious food products in specific circumstances.

The Standing Joint Committee for the Scrutiny of Regulations discussed this bill at their meeting of February 3, 2005, and concluded that it would address their concerns about the issuance of interim marketing authorizations.

[Translation]

Interim Marketing Authorizations would not be a means to bypass the normal processes in place within Health Canada for conduct of a safety review of a new food additive, pesticide or veterinary drugs to protect the health of Canadian consumers. These substances would still have to go through the normal regulatory process to amend the regulations to provide for their use or presence in foods sold in Canada.

[English]

Interim marketing authorizations could only be used for food additives, veterinary drugs, and agricultural chemicals that have already been subject to a thorough safety assessment before being listed in the regulations.

A second safety assessment would be conducted upon receipt of a request to expand the permitted range of foods in which one of these substances may be used or may be present.

Health Canada would only give consideration to issuing an interim marketing authorization if it had been concluded that the sale of the food product with a higher level of use or of new food products containing the substance in question would not pose a hazard to the health of the consumer.

¹ (1540)

[Translation]

Interim Marketing Authorizations would have to be published in the “Government Notices” portion of the Canada Gazette, Part I, so that all interested parties would be aware of it.

[English]

Madam Chair, by way of background on interim marketing authorizations, prior to this proposal the assistant deputy minister of the health products and food branch of Health Canada was given authority, in specific cases, to issue notices of interim marketing authorizations when, on July 3, 1997, Health Canada amended the food and drug regulations. This amendment to the regulations was introduced as an important regulatory reform initiative to bridge the time between the completion of a thorough scientific evaluation and the publication of the amendment in the Canada Gazette, Part II.

In terms of the use of this particular tool, since that time over 80 notices of interim marketing authorization have been issued. These comprise 53 food additives, seven additions of nutrients to food, 22 pesticides, and zero veterinary drugs.

The first amendment therefore proposes, as I've noted, to provide the minister with the limited power to allow for sale a food for which there's a reasonable certainty that no harm will result from its consumption, but which is not yet in compliance with specified provisions of the food and drug regulations in respect of a compositional requirement or adulteration provision.

The IMA would be applicable to veterinary drug residues, agricultural chemical residues, and the addition of food additives, mineral nutrients, vitamins, and amino acids. In the case of veterinary drugs, agricultural chemicals, and food additives, the IMA could only be issued to expand the permitted areas and levels of the use of substances if they're already listed in the regulations.

Now, Madam Chair, if you will permit, my colleague will provide some information regarding the pesticide maximum residue limits.

Ms. Karen L. Dodds (Executive Director, Pest Management Regulatory Agency, Department of Health): Maximum residue limits for pesticides are set following a careful scientific assessment that has established that there is reasonable certainty that no harm to consumers will result from the consumption of foods containing these maximum limits of pesticide residues.

[Translation]

It normally takes one year, and occasionally longer, from the time a pesticide is approved for use in Canada under the Pest Control Products Act to the time when the food potentially containing its residues is permitted for sale under the Food and Drugs Act.

[English]

Maximum residue limits for pesticides will continue to be set following the same thorough scientific review and stakeholder and international trading partner consultation.

[Translation]

The second amendment will allow the Minister of Health, under authority of the new Pest Control Products Act, to set Maximum Residue Limits in a significantly reduced time period. However, the new process will not affect how safety assessments are done.

[English]

This will level the playing field between Canadian and American growers by allowing Canadian growers quicker access to new, safer pesticides, registered through the joint review process with the United States. This will also further protect human health by allowing maximum residue limits to be changed more quickly following the re-evaluation of older products against more modern day standards.

Mr. Paul Mayers: In summary, therefore, Madam Chair, in keeping with the work on smart regulation, Health Canada is proposing these two amendments to the Food and Drugs Act to ensure that the very important and beneficial notice of interim marketing authorization mechanism can continue to be used by Health Canada to accelerate the introduction of some new and safe food products for Canadian consumers.

When the bill was tabled in the House of Commons on November 29, 2004, Health Canada sent a letter explaining the intent of this bill to stakeholders. To date, we have received no expressions of concern. The bill maintains the very important element of the protection of public health that is already recognized in the current interim marketing authorization mechanism in the food and drug regulations. The bill would continue to provide the availability of the beneficial mechanism to ensure that consumers have timely access to safe food products.

As I've noted, the application of the mechanism to date has provided for over 80 notices of interim marketing authorization, and as it relates to those notices, no expressions of concern about the safety of foods sold under those notices have been received by Health Canada.

Madam Chair, we have provided some background and details in a fact sheet and in additional information provided to the committee, and we look forward to sharing additional information with you through your questions.

Thank you, Madam Chair.

¹ (1545)

The Chair: Thank you very much.

We'll move to the question and-answer portion.

Are we starting with Mr. Fletcher?

Mr. Steven Fletcher (Charleswood—St. James—Assiniboia, CPC): No, I'm going to go with Mr. Merrifield today.

The Chair: Mr. Merrifield.

Are you sharing your time, Mr. Merrifield?

Mr. Rob Merrifield (Yellowhead, CPC): No, I don't think so.

The Chair: We only have an hour for this portion--we have 45 minutes left, actually.

Mr. Rob Merrifield: That's fine. I'll ask my questions and see how the answers come, and if I have time left over, I'll move on to another questioner. How's that? Is that fair?

The Chair: Yes, that's fair.

Mr. Rob Merrifield: Okay, as long as we do things fairly in this committee...because there have been times when accusations were levelled, and I wouldn't want that.

At any rate, let's get on with the questioning.

I want to thank the witnesses for coming forward.

I want to start with Ms. Dodds.

The last time you were before the committee, which I believe was the last government, we were talking about reviewing pesticides. There was going to be a review of about 400 different pesticides, and you had about two years to do it. Can you tell the committee how that is going?

Ms. Karen L. Dodds: This is Health Canada's re-evaluation program for older pesticides. We've undertaken a commitment to review all pesticides reviewed before 1995. We are doing a pretty good job in terms of keeping pace with the performance commitments we've had.

I'm not sure I have all the details. I've been less than two months at PMRA.

Trish, can you help me on how we're tracking with our commitments?

Ms. Trish MacQuarrie (Director, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health): Yes. We are making progress. In fact, we're following the U.S. EPA progress very closely. I believe we're intending to have approximately 182 of the 401 pesticides slated for re-evaluation completed this year, but we can verify that information and send it to you.

Mr. Rob Merrifield: Yes, I would appreciate that. It's very interesting that you're able to do that, because performance in the past was rather slow on this one, so you've certainly accelerated things. When you mentioned 400 at the time, I don't know if many on this committee felt you'd achieve that, so I'm pleased to see you're partially along on that.

Moving on to this bill and some of the 80 products you say have been allowed onto the market prior to full regulations or compliance, have there been any complaints received for any of those products as you've moved forward?

Mr. Paul Mayers: Thank you very much.

No, there have not been complaints. Even more important, perhaps, there has been no evidence of human health concerns related to the products authorized under the interim marketing authorization.

Mr. Rob Merrifield: What you're saying is there have been absolutely no recalls from moving ahead in this way, no changing your minds because evidence has come forward after the full review is done?

Mr. Paul Mayers: That's correct.

Mr. Rob Merrifield: That has been happening since July 3, 1997, you are saying.

Mr. Paul Mayers: That's correct.

¹ (1550)

Mr. Rob Merrifield: Was the minister acting in full accordance with all the rules when moving forward on all of these at that time?

Mr. Paul Mayers: Once the provision was available under the food and drug regulations to issue interim marketing authorizations, the department, upon the request of petitioners, considered the evidence presented by petitioners to support the issuance of an interim marketing authorization. Where that evidence demonstrated the safety of the product, whether it was an extension of the use of a food additive or the addition of a nutrient to food--by far the largest groups of products permitted--we made the issuance of interim marketing authorizations in full accord with the regulations available at that time.

Mr. Rob Merrifield: Just to capture exactly what this bill is doing--it's just moving it from the regulations into the act.

Mr. Paul Mayers: That's correct. It moves it from regulations into the act, and in part that's a result of the concerns expressed by the Standing Joint Committee for the Scrutiny of Regulations.

Mr. Rob Merrifield: Is the information on which you base your decisions mainly from the United States, or does it come from Europe and other countries? How do you weight the criteria for whether you think the safety has been met?

Mr. Paul Mayers: The safety assessment process for the types of products that are covered here is laid out, in the case of food additives, in the regulations themselves.

We apply a totality of evidence consideration. Petitioners provide to us the evidence upon which they believe they can demonstrate the safety of the products. Our experts in the department review the information presented against the backdrop of the scientific literature. So we will consider the evidence base from a range of sources, not just domestic sources but international sources, because we use the international science literature.

Mr. Rob Merrifield: Thank you. I'll leave the rest of my time to Mr. Lunney.

The Chair: Mr. Lunney, you have five minutes.

Mr. James Lunney (Nanaimo—Alberni, CPC): First, you listed some 82 IMAs that have been approved or at least released. I'm just wondering if you would go over that list, because you were a little ahead of me. I didn't catch it. Could you give me the breakdown of what areas those products were in?

Mr. Paul Mayers: Certainly. There were 53 food additives, seven additions of nutrients to foods, 22 pesticides, and zero veterinary drugs.

Mr. James Lunney: When we're talking about the IMAs, does it indicate how long these IMAs are in effect once they're approved? Is there a time limit or an expiration date?

Mr. Paul Mayers: Indeed. In the bill there is an explicit requirement limiting the time of an IMA to two years, so the department would have that two-year period in which to complete the regulatory amendment process. If that were to not be concluded within the two-year time period, the IMA would effectively be cancelled at the two-year mark.

Mr. James Lunney: Thank you.

Here's a more practical question: I'm just going back to the types of things that are regulated here. The list goes on to include agricultural chemicals, veterinary drugs, a food additive, a vitamin, a mineral, a nutrient, an amino acid. Now, on the one hand we're dealing with things that are very toxic and that people might have a very big concern about having in their food in any level. Pesticides and herbicides are persistent organic pollutants. These residues we're concerned about actually stay in the food chain and can remain in biological systems for a long time.

Then you're also putting things that are good for you in there, like maximum levels for nutrients. Is there some concern that nutrients are going to be put into food in an exorbitant amount that could be considered risky?

Mr. Paul Mayers: It is certainly a possibility that one can have too much of a nutrient. Certain nutrients have very specific limits above which adverse effects occur. For example, excessive intakes of vitamin A can result in harm, for example, to a fetus. So in those cases we do express maximum limits. But minimum limits are an equally important consideration when dealing with nutrients.

¹ (1555)

Mr. James Lunney: Yes. Is there any evidence that anybody would ever attempt to put into a food form, as an additive to a vitamin-enriched cereal or something, a level of a vitamin that is in a toxic range? I've never heard of such a thing.

Mr. Paul Mayers: That would be under the department's control, to avoid that occurrence, whether it was intentional or inadvertent.

Mr. James Lunney: I just find it surprising. It seems to perpetuate this myth about how toxic vitamins and minerals are, which is really not supported by modern-day science. You mentioned vitamin A, but to get vitamin A in greater than 20,000 international units as a food additive is something that's not likely to happen.

I'm just puzzled that they would be lumped in there with toxic items, and why you'd be concerned about that. And you can't give me an example, other than vitamin A, and I can't imagine anybody adding over 10,000 international units of that to a cereal.

Mr. Paul Mayers: Another example of a toxic adverse effect---

Mr. James Lunney: We're talking about food items; we're not talking about pesticides or herbicides now.

Mr. Paul Mayers: You can get iron in toxic---

Mr. James Lunney: But is there any example anywhere that there's a food item or something that you might regulate as food that somebody has added a toxic level of iron to?

Mr. Paul Mayers: I certainly can't draw an example for you from the top of my head.

Mr. James Lunney: So we know that most vitamin and mineral supplements don't include iron, except when specifically marked. But I can't imagine anybody giving vitamin-enriched, iron-enriched food items. I've just never heard of it.

Mr. Paul Mayers: One of the interesting things when the diet is used to present nutrients that are added above the normally occurring levels is the totality of intakes. So while the intent may not be to add, for example, vitamin A to a product at levels that would raise concern, the other things one consumes in a day might put you above that limit if there aren't appropriate controls across the range of foods. While one food might not put you above the limit, presenting 100% of your daily recommended intake of vitamin A in every food would certainly put you above that intake. No one manufacturer would recognize that their level was contributing unless there were appropriate controls in place.

So that's the kind of event that would be managed through appropriate controls that would not relate to a direct and intentional addition above a safety limit.

The Chair: Thank you, Mr. Lunney.

Mr. Ménard.

[Translation]

Mr. Réal Ménard (Hochelaga, BQ): Thank you, Madam Chair.

To be quite honest with you, when I read over the noon hour the briefing notes sent to us by the Clerk, I didn't' understand any of it. Therefore, I'd like us to go over the bill in greater detail.

First of all, I'd like you to explain to us the aim of the proposed legislation. I understood that the purpose of the bill is to authorize the issuing of interim market authorizations. Interim as opposed to what? What is the meaning of “maximum residue limits”? That expression is used at least 20 times in your documents, although no definition is provided. Can you explain the meaning to us in relation to the current food certification system and the Food and Drugs Act?

You maintain that you have not received any notice of any objections to the bill. We know of some opposition from two sources, namely the Canadian Health Coalition and from three former Health Canada researchers.

Therefore, please enlighten us about the bill and what it means to the present regime. Please define for us all of the technical terms used.

Mr. Paul Mayers: As for giving you a more technical explanation...

Mr. Réal Ménard: Please enlighten us. You've managed to be technical enough.

Mr. Paul Mayers: My colleague Ms. Dalpé can explain the bill to you.

Ms. Claudette Dalpé (Associate Director, Food Regulatory Programs and Access to Information, Bureau of Food Regulatory, International and Interagency Affairs, Food Directorate, Health Products and Food Branch, Department of Health): First of all, interim marketing authorizations are already issued under the existing regulations, as was explained in the opening statement and in the fact sheet accompanying the letter sent to interested parties.

Interim marketing authorizations are so named because they are a measure that applies between the time a food substance is assessed for its safety or evaluated to determined that the presence of pesticide residue in a food product does not pose any kind of health risk...

º (1600)

Mr. Réal Ménard: Can you give me an example of a residue?

Ms. Claudette Dalpé: My colleague Ms. Dodds might be better able to explain what a residue is and how maximum residue limits are set.

Mr. Réal Ménard: Finish up explaining interim marketing authorizations. We'll move on to the subject of residues later.

Ms. Claudette Dalpé: In that case, I'd like to focus on the subject of food additives.

Mr. Réal Ménard: All right.

Ms. Claudette Dalpé: Speaking of food additives, according to the existing regulations, if someone wants to use an additive that is already on the list in a product...We're talking about a positive list. A food product containing an additive cannot be sold unless the additive is listed in the regulations.

Am I making myself clear so far?

Mr. Réal Ménard: A certain number of products contain food additives that must first be approved by Health Canada.

Ms. Claudette Dalpé: You're absolutely right. That doesn't change anything in so far as the existing interim marketing authorization scheme is concerned. The same goes for the addition of vitamins, minerals and amino acids to foods.

Mr. Réal Ménard: Regulations are already in place.

Ms. Claudette Dalpé: Correct.

Mr. Réal Ménard: Why then is an interim marketing authorization required?

Ms. Claudette Dalpé: The interim marketing authorization, which is a regulatory provision of sorts, was approved by the Governor in Council in 1997 for the purpose of allowing us, once the product containing the maximum limit had been analysed and found not to pose a health risk, to authorize the immediate sale of the product pending amendments to the regulations in order to add this additive to the list.

Mr. Réal Ménard: Who is requesting that?

In the briefing notes that we received, mention is made of a potential threat to producers from the standpoint of competition.

Ms. Claudette Dalpé: I'll let my colleague respond to that as she is knowledgeable about pesticide residues. However, regarding food additives and the addition of vitamins and other nutrients, food manufacturers are in fact the ones requesting authorization to put these additives in their products.

Mr. Réal Ménard: I hope you can continue to educate us on this subject—it's going well so far. Can you give me an example of a food manufacturer in Canada?

Ms. Claudette Dalpé: Kraft is one example.

Mr. Réal Ménard: Are you referring to Kraft Dinner, the infamous product that was the bane of our childhood?

Ms. Claudette Dalpé: I don't mean the product, but the Kraft company, a food manufacturer.

Mr. Réal Ménard: It produces cheese.

Ms. Claudette Dalpé: And many other products as well.

Mr. Réal Ménard: Yes, I'm familiar with the company. It operates a plant in my riding.

Ms. Claudette Dalpé: That's right.

Be that as it may, before a manufacturer or company can market a food additive, it must first seek approval of the product so that other manufacturers can include it in the food preparation process.

Mr. Réal Ménard: In what way would the passage of the bill benefit the public?

Ms. Claudette Dalpé: The advantage would be that the public would have access to safe, and often innovative food products. Product quality could also be improved. Of course, speaking of nutrition—and Mr. Lunney alluded to this earlier—, additives and nutrients, having food products with added nutritional value is clearly a benefit to consumers.

Mr. Réal Ménard: I understand.

Let's get back to the subject of residues.

[English]

The Chair: Mr. Ménard, you asked some pretty piercing questions, so you may not ask another one, but I believe someone else on the panel was going to respond to one of your earlier questions, and I will allow that.

Ms. Dodds.

[Translation]

Ms. Karen L. Dodds: Mr. Ménard asked a question about maximum residue limits.

[English]

When pesticides are used on food-producing crops, on any of the crops that subsequently are consumed either by people or by livestock, they leave residues, and part of PMRA's responsibility in the scientific and health assessment is to make sure the residues that are left on the part of the crop that will be consumed either by humans or by animals are acceptable.

We review toxicological information submitted to us to ensure that consumption of those residues every day for all of your life at the maximum level does not pose a health concern to Canadians. PMRA has, as part of its scientific assessment, a specific focus on vulnerable populations, so we look at children, for example, as a more vulnerable population, and we add a safety factor. Again, our intent is to make sure that if you were consuming foods with these residues on them, they would not pose a risk.

º (1605)

The Chair: Thank you very much.

We'll now move on to Mr. Thibault.

[Translation]

Hon. Robert Thibault (West Nova, Lib.): Thank you, Madam Chairman.

I want to thank Mr. Ménard for doing an excellent job in seeing that committee members are enlightened on this matter. Our witnesses had a genuine opportunity to explain the aims of this bill thoroughly to us.

[English]

I want to focus a little bit on the pesticide component, the maximum residue limits.

I would ask you to explain to the committee, and through the committee to the Canadian people, how our producers are advantaged by doing that, how we are working now with the international community, particularly the U.S., in the analysis of new pesticides or new use of existing pesticides, and how this will assist the competitiveness of our Canadian producers.

[Translation]

Ms. Karen L. Dodds: Thank you for your question.

[English]

The agriculture sector certainly has often raised to the attention of the Pest Management Regulatory Agency concerns about their competitive position, because there are many more pesticides permitted for use in the United States than there are in Canada.

In our harmonization activities and our intent to try to help the agriculture sector in Canada, we do not rely on any U.S. decisions. Instead, we work in many instances directly with the United States in our scientific review. We will undertake joint reviews of new active ingredients. We will undertake joint work on reduced or low-risk pesticides. On our re-evaluation program, which was the subject of Mr. Merrifield's first question, again in those situations we look at the outcomes of U.S. work. We don't just accept their decision, but we look at the outcomes of their work to determine whether or not they're applicable.

This allows us to move more quickly in terms of supporting the registration of pesticide products for farmers and for the agriculture sector in Canada, but we still have quite a challenge in front of us.

Hon. Robert Thibault: Thank you.

I think it's important to point out that when you're talking about residue in food or pesticides in food we're not talking about adding them. It's understanding that on a carrot, a little bit of residue of pesticide, an amount so minuscule it's difficult to measure, would make its way into the food chain. Am I right?

Ms. Karen L. Dodds: You are right, for the most part. I've just learned recently, for example, that many of the pesticides that are used on things like apples are actually applied even before flowering. So there would be no residue on the apple because of the timeline. We make sure of that in our evaluation. That is part of our process, to make sure that whatever residue is there is acceptable from a health perspective.

Hon. Robert Thibault: Thank you.

On the interim marketing agreement, this is nothing new--no new regulations, no change in implication. It's the way that it's written into the law. This is after the Standing Joint Committee for the Scrutiny of Regulations had expressed their concerns.

That having been said, we received their concerns and we are reacting to them. Do the existing interim marketing agreements remain valid after we approve this law and at the current time?

Ms. Karen L. Dodds: One point I'd like to make is not specifically on the question of the interim marketing authorizations. This committee looked at the new Pest Control Products Act, which was given royal assent in 2002, and the new Pest Control Products Act did give the Minister of Health the authority to set maximum residue limits in that act. So part of Bill C-28, the bill in front of you now, is also to say, allow the Pest Control Products Act to be the vehicle for setting maximum residue limits and preventing a duplication. If you didn't do that, you would have them under the Pest Control Products Act and under the Food and Drugs Act.

So this puts all of the setting of the maximum residue limits with the Minister of Health. That is something that was approved by this committee and passed to Parliament, and the bill was given royal assent in 2002.

º (1610)

Mr. Paul Mayers: With regard to the issue of the existing notices of interim marketing authorization, indeed, included in the bill is a deeming provision that would have the effect that any interim marketing authorizations that were in place at the time this bill came into effect would be recognized as interim marketing authorizations within the context of this bill, so as to avoid that potential problem of a duplication.

The Chair: Thank you, Mr. Thibault.

Ms. Crowder.

Ms. Jean Crowder (Nanaimo—Cowichan, NDP): Thank you, Madam Chair.

I just have a couple of comments. I think I heard somebody say that part of the purpose with this was to accelerate a product getting to market. Is that...? Okay.

A number of people have talked about the Pest Control Products Act, which was changed in 2002. Have the regulations from that act been promulgated? Are they now in place?

Ms. Karen L. Dodds: No, unfortunately, they're not. A number of sets of regulations are still under development. It is our goal to have them all in place this calendar year so that the new Pest Control Products Act can be put into force.

Ms. Jean Crowder: That actually doesn't lead me to a degree of confidence in talking about waiting to get regulations put into place. Specifically, under the new Pest Control Products Act, there were a number of steps laid out that seemed to really take the public interest into account. It was talking about things like establishing a public registry; allowing the public to view the test data on which these pesticide evaluations were based, which would seem reasonable given what we're talking about; and allowing the PMRA to share scientific studies with provincial and territorial governments. The reason I'm raising this issue is that the PMRA recently put out an information notice that said that 2,4-D can be used safely on lawns and turf. Yet the public process for submitting information isn't even completed. It's not, up until April 22.

So when you talk about interim measures and putting regulations in place, I'm not sure that the public safety is actually being protected. I would suggest it would be more expedient to actually ensure that all data are in. If there's a problem with regulatory process, that it takes too long to get things happening, we need to look at what that regulatory process looks like rather than looking at interim measures.

I'd like you to comment on that.

Ms. Karen L. Dodds: Thank you for giving me the opportunity to clarify. As I said, I'm new at PMRA, with less than two months on the job, and it is good to have an opportunity to clarify.

With documents such as the decision on 2,4-D, that is considered right now as a proposed acceptability, so it's not a final decision. It's still waiting for final comments to come.

Ms. Jean Crowder: If I could interject, though, the headline on the information note that comes out from PMRA says, “The PMRA Determines that 2,4-D Can Be Used Safely on Lawns and Turf”. This is a headline that says this, yet there's more information coming in. So I'm not sure the public will always go down to read the fine print when that's the headline.

Ms. Karen L. Dodds: We are working to clarify our communications. In the instance of things like 2,4-D and with all of our pesticide registration and re-evaluation decisions, internally we will make every effort to access all relevant material.

Ms. Jean Crowder: And make it available to the public.

Ms. Karen L. Dodds: Yes.

Ms. Jean Crowder: That's good news.

Ms. Karen L. Dodds: We do have quite an extensive scientific document that's available on our website about how we re-evaluated 2,4-D and what the scientific information is, with reference lists and everything.

We do need the new Pest Control Products Act to be able to have people access business confidential information in a private reading room, but we still do try to make as much available as we can.

Again, what I want to emphasize is that there is this issue with what's now under the IMA and where we want to set maximum residue limits. That is where we are convinced that we have all of the information needed in our hands and it's been evaluated in order to set a maximum residue limit.

Currently, with the IMA--

Ms. Jean Crowder: Can I interject for a second? When you talked about maximum residue limits, I have a quote from the United Kingdom that says that a maximum residue level is actually defined as a legal limit, not a safety limit. Does that same thing apply in Canada, the legal limit versus the safety limit?

Ms. Karen L. Dodds: But that would be because usually it is much below. The actual residue detected is now usually orders of magnitude below the legally acceptable maximum residue limit. But it's important for people to realize that we look at this high limit to make sure that's acceptable. But as we noted with the instance of apples, or any of these, there are normally both environmental and processing and degradation things that happen, so that the residue limit on consumption actually is much below what we would expect to find in the field.

But we set our maximum residue limit for what you could have in the field under good agricultural practice. We make sure that is appropriate, but typically what you actually measure... Actually, I've questioned our people recently and most of the times now residues are below the limit of detection. That's why some people will refer to them as a legal limit, not a safety limit.

º (1615)

Ms. Jean Crowder: Am I done?

The Chair: If I could just follow up, though, considering the press release Mrs. Crowder referred to and considering the fact that you've only been there two months, have you issued something that is clearer about this? It seems that the headline is quite misleading to the public, and yet that was picked up by the press and I have had many phone calls in my riding office about it.

Are you putting out a second press release that will correct the false impression left by the first one? Probably an over-enthusiastic communications person did that, I'm guessing. But what are you doing about it is what I'm asking.

Ms. Karen L. Dodds: The normal process is to accept comments to the close of the comment period, and then obviously another document would come out, and it may say that we've received significant new information and need to re-evaluate; it may say that there was no information received that was relevant to the scientific evaluation of 2,4-D.

What we have done with parties who have written in to us has been to clarify--and I think that is part of the press release--that this is a comment period, which is open until the date later in April.

The Chair: Thank you.

Mr. Savage.

Mr. Michael Savage (Dartmouth—Cole Harbour, Lib.): Thank you, Madam Chair.

Welcome to our panellists.

I wonder if you could explain to me the mechanics, the process, of how this IMA gets issued. You get a notification from a company that it's looking for one, I assume?

Mr. Paul Mayers: The first step would be the submission from a proponent or a petitioner for the extension of use--in the case of food additives or nutrients--beyond that which is currently permitted in regulation. We would assess that proposal on its merits in terms of the human health implications of extending that use or modifying the levels, based on the scientific information submitted supporting the safety of that application. Once the science assessment is concluded, and there is indeed a determination that such an application is a safe application from a consumption perspective, then the issue of moving forward revolves around the question of how to operationalize the decision-making.

A proponent might make the request that in addition to the extension, an interim marketing authorization would also be desirable. Provided the criteria for an interim marketing authorization were met, then that would be considered.

So your process would then unfold, starting at the very beginning, the first science assessment of that particular substance that resulted in its listing in the food and drug regulations, and that would be without any interim provision. Then the second review for the extension, which I mentioned, and then the application for an IMA would be reviewed against the criteria. And if all of those were acceptable, then the IMA would be granted while the process of completing the regulatory amendment to add either the new usage or the extension of usage to the existing listings in the regulation would then be completed.

Mr. Michael Savage: So there have been 82 of these notices of IMAs. Is that correct?

Mr. Paul Mayers: That's correct.

Mr. Michael Savage: How many applications were there for these?

º (1620)

Mr. Paul Mayers: I was conferring with my colleague. I don't have the information on how often a petitioner made a request for an IMA but didn't meet the criteria. For example, we do occasionally receive requests for IMAs where it's a new listing. We cannot issue an IMA in that situation, for a new listing.

Mr. Michael Savage: But of those that would be eligible for it, could you give me a percentage? Would it be 90%, 10%?

Mr. Paul Mayers: I would simply be guessing, so I would prefer not to speculate.

Mr. Michael Savage: Okay, thank you.

That's all I have, Madam Chair.

The Chair: But I thought I heard Ms. Dalpé say that for 82 approvals, there were 82 applications. Is that not correct?

Ms. Claudette Dalpé: No. If I may be permitted, I would like to clarify this information. The applications that were successful are the 82 IMAs. There may have been applications that were turned down.

The Chair: That's what we want to know.

Ms. Claudette Dalpé: We don't have a number on those.

The Chair: Surely you have a record of those you've said no to.

Mr. Paul Mayers: Absolutely, and that information can be provided.

The Chair: Thank you.

Thank you, Mr. Savage.

Mr. Fletcher.

Mr. Steven Fletcher: I just have one question. On one hand, I can see the benefits to expediting the approval process...or, I guess, the reason for the IMA seems to be valid. But on one hand, can you provide assurance that Health Canada goes through the process as quickly as possible to reduce that lag time where the IMA is needed?

The second part of my question is, can you also assure the committee that this process is done beyond the reach of market pressures or political pressures? I can foresee situations where you guys could be put under a lot of pressure to make one decision or another.

Mr. Paul Mayers: Thank you.

The process is guided by very clear criteria, and it is on the basis of criteria the decision to issue or not to issue an IMA would be made. That criteria set has now been laid out as well in this bill and would constrain the decision-making to the application of those criteria as it related to the IMA process.

In relation to the first question, we certainly work forward on as expeditious a basis as we can to conclude the regulatory amendment process, and that is the exact reason in the bill the proposal includes the time limitations, so as to ensure the department continues to have the requirement before it to conclude the regulatory amendment process and complete the listing in regulations within the two-year timeframe provided by the IMA. It's because at that point, if we have not achieved that, then the IMA will cease to be available. It is, in the context of both of your questions, a manner explicitly articulated in the bill to address...so the department is not operating in a subjective manner. We have an explicit timeline in which to conclude the regulatory amending process, and we have explicit criteria that guide the issuance of an IMA.

Mr. Steven Fletcher: So the department is insulated from political pressures either way?

Mr. Paul Mayers: What I can say--because I can only speak to the technical application--is that the department operates within the context of the criteria currently laid out in regulation and proposed to be laid out in the Food and Drugs Act itself.

The Chair: Thank you, Mr. Fletcher.

Ms. Chamberlain.

Hon. Brenda Chamberlain (Guelph, Lib.): I'd like to follow up a little bit on Mr. Fletcher's question.

For a long time farmers and fruit growers have not been very happy with the process through PMRA. They feel things are held up for a very long time and they can't get their things to market. Many times they're not competitive. It goes back to Mr. Thibault's question about not being able to get into the marketplace.

I recognize that we have to be safe and we have to be careful, but there are huge concerns around PMRA as to how they handle things. Do you wish to comment at large? I'm sure this question is not a surprise to you; it's been around for quite some time and people are pretty hot about this.

º (1625)

Ms. Karen L. Dodds: I started as executive director February 14, and by February 20 I was out meeting with stakeholders because I know there are concerns. Certainly, a large number of those, the majority of the concerns, come from the agricultural sector, so key for me in these early days is understanding what the nature of the concerns is.

As I said, regarding this difference in how many pesticides are approved in the U.S. versus how many are approved in Canada, PMRA has made progress in terms of starting now to actually, on a yearly basis, approve much the same as what's in the United States, but we also have to make.... We started out with quite a significant difference. I'm still talking with stakeholders, with people inside PMRA, about the ways and means, but all of these kinds of things....

Madam Chair, if I might also come back to the last question about protecting the process from any untoward influence, under the new Pest Control Products Act it will be very specific. It will actually be in the act, not in the regulations. The health risks associated with maximum residue limit specified by the minister must be considered acceptable to the minister. It goes into a description of looking at aggregate exposure, cumulative exposure, and the different sensitivities, so it will be right in the act. I'll call it a buffer between undue pressure on approving....

But at the same time, the regulatory process...we can be all through our scientific evaluation. I asked our people to do an analysis, and it's about 18 months in addition,compared to going through the regulatory process. So at minimum, with the IMA, the agriculture sector is 18 months, more than a growing season, ahead of what they used to be in terms of access.

Hon. Brenda Chamberlain: So there is some improvement.

Ms. Karen L. Dodds: Yes.

Hon. Brenda Chamberlain: That's a good thing.

The Chair: Thank you, Madame Chamberlain.

Madame Demers.

[Translation]

Ms. Nicole Demers (Laval, BQ): Thank you, Madam Chair.

Mr. Mayers, since there is apparently no risk associated with fast-tracking the interim marketing of these food products, can you tell me why the advisory committee working on this matter issued a report recommending—I believe in recommendation 46—that Health Canada employees enjoy immunity in the event products for which interim marketing authorizations have been issued are subsequently found to be harmful?

[English]

Mr. Paul Mayers: I am trying to think of any application where the output was a decision to authorize an IMA and there was concern regarding the toxicity of the product, and I am not aware of any such example. As we have noted, the first and foremost consideration prior to the issuance of an IMA is that the application in question, the substance proposed, and the level of its addition are at a level and of a nature that do not represent a risk to the individuals consuming that product in the marketplace. Keep in mind that the intent of an IMA is simply to bridge the period between the completion of that scientific assessment and the regulatory listing.

So the ultimate decision relates not only to the issuance of the IMA, but to the intent to list in the regulations the authorization of that substance and at that level. On that basis, in addition to not being aware of any circumstance where a concern had been identified, we would also not entertain the issuance of an IMA that would then result in a regulatory amendment, creating a listing for a product for which we had a concern.

º (1630)

[Translation]

Ms. Nicole Demers: You haven't answered my question. I was wondering why the advisory committee was recommending immunity for Health Canada employees. You merely responded by saying that none of the products posed any risk. However, everyone knows that over a period of 18 months, the additional timeframe provided for in the case of these products, many things can change. Last week it was announced that Vitamin E can, when taken in large doses, be quite harmful and can even cause cancer. It was also reported that aloe vera, when used in the early stages of a pregnancy, may harm the fetus.

Science helps us to benefit from new breakthroughs quickly. I think we're disregarding or not paying enough attention to the health of Canadians and Quebeckers by moving so quickly to approve a product that might contain an additive and that might not have been adequately tested to ensure its safety.

[English]

Mr. Paul Mayers: I can only respond in the context of what the science tells us. I can assure the committee of the comprehensiveness of this review. It is indeed possible that new science may emerge. When this happens, in the light of evidence reflecting a new level of information, decisions may be made to cancel a listing.

I didn't provide any information on the issue of immunity, because I simply don't have any. But on the issue of the length of testing of an additive, for example, and the possibility that additional information may come to light in the future, the comprehensiveness of the science used at the decision-making point is the only basis we have. Science that might emerge in the future is not available when the decision is taken. However, when new science emerges, it is incumbent on us to take that new science into account and to consider it in relation to products in the marketplace and their potential effect on public health.

The Chair: You said in your original presentation that 82 of these certifications had been issued and you'd never had a consumer complaint. But did you really expect one? After all, some of these additions to a product are things like microcrystalline cellulose added to breath-freshening strips. I wonder how many consumers knew as they bought their breath-freshening strips that you had just allowed for the addition of microcrystalline cellulose. I wonder how many realized that in plant-based beverages—I suppose that's like tomato juice—you had allowed amalase and proteinase enzymes to be added. Surely you didn't expect consumers to react to those scientific names being added as one more ingredient to a product they were used to buying. Is it not rather disingenuous to suggest that the lack of consumer complaint is a positive thing in this particular process?

Mr. Paul Mayers: I'm not suggesting that the lack of consumer complaint is the sole consideration. While consumers are the most important stakeholder in the process, they're not the only stakeholders. Stakeholders who see the listings may raise concerns. Some are extremely expert in their ability to assess a new listing and to express a concern. But you're correct that certain listings, being technical in nature, have a much lower potential to raise concerns. Keep in mind that these same listings have gone through the gazetting process, part I and part II, to achieve the original listing, which is an absolute requirement before--

º (1635)

The Chair: Excuse me, I understand what you're saying, but I'm not aware of which groups are following that gazetting process. It seems to me from what you've said, and from what Ms. Dodds has said, that this is a manufacturer- and producer-driven process. The number of nutrients being added is much smaller than the number of agents that firm the product, help to make it last longer, etc. These chemicals that add to the shelf life, the appeal to the consumer, or the feel of the product are much more in evidence than actual nutrients. Of all additions, seven were nutrients and 53 were additives requested by the manufacturer. It seems to me that those numbers alone suggest that this is definitely producer-driven. It's what they want to put on the shelves, or what they want to turn out of their fields, that is driving this process. Consumers have very little to do with it. Are you aware of which groups are following these additive IMAs carefully and responding to you? You said you had no consumer complaints. Did you receive complaints from anybody? Complaints would indicate that someone is at least watching what you're doing.

Mr. Paul Mayers: We did indicate that we didn't receive any complaints, and it's not just consumers whose complaints we are referring to. We didn't receive expressions of concern from stakeholders more generally.

The Chair: Is anybody watching these listings, to your knowledge? Anyone other than your own scientists, who are allowing these things?

Mr. Paul Mayers: We believe that's the case, but I can't confirm for you, because of course, I don't have the information related to the groups and what they track and don't track, Madam Chair.

The Chair: Okay, there may be a paucity.

I'll move on to Mr. Carrie.

Mr. Colin Carrie (Oshawa, CPC): Thank you very much, Madam Chair.

My questions actually follow what Madam Chair was bringing up. They are really to do with public safety issues. My concern is whether Canadians know what's in their food, and do they have the right to know what's in their food?

I was wondering whether you put things out when you change a product? Are there any consumer alerts or product alerts so that Canadians will now know that this product has been changed?

Mr. Paul Mayers: We certainly don't provide notices on individual products. What we do, using food additives as the example, is this. A division of the food and drug regulations lists all food additives that are permitted and the products to which their addition is permitted. The issuance of an IMA would be included in government notices, so that too would be alerted through the mechanisms we have available to us. So we have the regulations themselves and the listings included therein. We have the Canada Gazette, and we use that. And of course, there is our website. Then on the product itself, of course, additives are identified in the ingredients list, as provided for in the regulations.

Mr. Colin Carrie: What bothers me more are things such as that we now have significant antibiotic use in our cattle. We're feeding our cattle antibiotics. Now, actually, with BSE problems, we're feeding our cattle our cattle. Are we promoting that by putting extra antibiotics in the feed?

You talk about the science; you're looking at the science. What exactly is the science? You talk about clear criteria. Do you receive transcripts or papers from companies and review them? Do you do any independent research on your own?

º (1640)

Mr. Paul Mayers: Absolutely. We are involved in research. We don't conduct specific research on an individual product, but we certainly undertake toxicological studies related to classes of products, for example, and that information assists in the evaluation process. But it's not limited to just what Health Canada itself generates. There is the international literature as well that we rely on, and in addition, the information provided by the proponents of the products themselves.

Mr. Colin Carrie: We have things like estradiol that is allowed as a growth promoter here in Canada but is banned in the U.K. and in Europe. Is there anything that allows Canadians to know what exactly is allowed and what the potential is to cause damage?

Mr. Paul Mayers: Again, in terms of the products permitted, that information is made public. So whether it is a veterinary drug or a food additive, the information that that product is now permitted is part of the process. The regulatory amendment process includes the opportunity for consultation and input in that amendment process.

Mr. Colin Carrie: My concern is just awareness--so Canadians are aware that these things are in the products--and their right to know. If I could make a suggestion, maybe that is something we could move forward. This whole bill, the way it seems to be put forward, does concern me, as far as public safety issues and the potential for having problems with them.

Thank you, Madam Chair.

The Chair: Thank you.

Everyone has now had a chance to ask questions of these witnesses. On your behalf, I will thank them very much for coming.

As Health Canada officials, we may reserve the right to invite you back, because the other testimony may give rise to other questions. I thank you very much for your presence today and your presentation.

We will now call forward to the table our second set of witnesses.

Welcome to our second set of witnesses.

We will begin with Mr. Michael McBane, the national coordinator of the Canadian Health Coalition, and one of our frequent witnesses. Being in that coalition, he is one of our great external advisers.

Mr. McBane.

Mr. Michael McBane (National Coordinator, Canadian Health Coalition): Thank you, Madam Chair. I'd like to thank all members of the committee for this opportunity to share with you our analysis and concerns around the bill before you, Bill C-28, proposed by the federal Minister of Health.

As you know, we appeared before you on the matter of pharmaceutical issues; we were very pleased with your last report, “Opening the Medicine Cabinet: First Report on Health Aspects of Prescription Drugs”. We would say that the direction of Bill C-28 is the exact opposite of your report on prescription policy.

Bill C-28 is being sold as smart regulation. You've heard that previously by the departmental spokespersons. We would agree that it is smart. According to theConcise Oxford Dictionary “smart” means “severe enough to cause pain”; “selfishly clever”; “verging on dishonesty”; and “unscrupulously clever”. Bill C-28 is very smart, especially when you examine the consequences of the substances we're talking about, with which they're adulterating our food. It is not a technical matter; it does impact on safety.

This bill involves notices of interim marketing approvals for food additives in infant formula and genetically modified organisms. These products are currently in our food supply; we're feeding them to our children, and the department has already acknowledged they haven't even finished the regulatory examination period.

Worse than that, there isn't even a scientific method in existence in the world to examine genetically modified organisms. We can't even examine mad cow disease, yet we are being told everything is safe--safe without even looking at it.

It's important for members of the health committee to understand why the scrutiny committee considered this notice that's being used--interim marketing authority--to be illegal. It's illegal because it violates the Food and Drugs Act. It's illegal because these substances are not safe; that's why it's illegal.

The Parliament of Canada is being asked by the Minister of Health to pass Bill C-28. One of the consequences would be to absolve the department that issued the 82 illegal notices. So instead of covering the tracks retroactively, as per clause 4 in Bill C-28, and thereby attempting to evade liability for regulatory negligence, the Parliament of Canada must hold these officials to account for failing to uphold the law. Canadians don't want their health protection weakened, even if it's done in a smart and unscrupulous manner. They don't want the Food and Drugs Act gutted wholesale by means of the minister's new proposal for a Canada Health Protection Act, nor do Canadians want their safety rights gutted in piecemeal fashion by Bill C-28.

I want to give an example of what we're talking about on Bill C-28, because I agree with very many members--it's very difficult to understand exactly what this is and what its consequences are. You have to move from the general to the particular.

A particular case study, and a member mentioned it, was estradiol. I'd like to use estradiol as a case study to walk you through what interim marketing authority and maximum residue limits are all about.

Health Canada approved six hormones for use in beef production that are banned in the European Union. I won't mention all six, but the one I'll talk about is estradiol. According to the Scientific Committee on Veterinary Measures Relating to Public Health--European Union, April 30, 1999--in the case of estradiol these's a substantial body of recent evidence suggesting it has to be considered a complete carcinogen--a complete carcinogen. It particularly affects children and women.

The human epidemiological studies point to estradiol as a carcinogen adding approximately 3% breast cancer risk per year of exposure. The European Union has said, with hundreds of pages of scientific references, no threshold levels can be established for a safe use of a carcinogen like estradiol.

Health Canada has approved estradiol. I found about 70 DIN numbers with estradiol and other banned substances, hormones, that Health Canada has approved.

º (1645)

So when you were told by the officials a few minutes ago that everything is safe, that you shouldn't worry, that it's all scientific...there is no science on estradiol in terms of establishing a safe threshold.

The European Union asked the Government of Canada, through the WTO, for its risk assessment on estradiol. That's a pretty reasonable question. If it's scientifically regulated, if it's science-based regulation at Health Canada, show us the science. The World Trade Organization was not allowed to look at Health Canada's risk assessment for estradiol. It was not even allowed to look at the drug reviewer's assessment. They were told it was secret. Well, I'm telling you that if it's secret, then it's not science. Science is something that can be verified and replicated in the public domain.

I don't think it's good enough for you to be told that everything has been rigorously assessed. Where is the science? You should be asking. They gave you a mathematical number of the permits, but they didn't tell you what products. The chair mentioned a couple; where are the risk assessments for those products? Good luck in trying to get them if the WTO can't get them.

It would be imprudent and unwise for this committee to take the department at its word without being given any evidence, or any scientific proof, these products have been assessed in a proper manner.

Here are two quick examples. Regarding pesticides, you are aware of the recent audit of the Commissioner of the Environment and Sustainable Development. The commissioner said, “Overall, we conclude that the federal government is not managing pesticides effectively. ... The range of weaknesses raises serious questions about the overall management of the health...risks associated with pesticides.”

We're talking particularly of poisoning our children; I find it quite disturbing to hear health committee members talking about expediting access to carcinogens that particularly attack young girls and pregnant women.

Here is another example, from the veterinary drugs directorate. As you know, senior managers recently fired several scientists in the human safety division of the veterinary dugs directorate after the veterinary drug industry identified their focus on safety and efficacy as a barrier to doing business. They called it “re-engineering the bureau” and “we are moving away from the review of efficacy”. This was in exchange to agree to pay cost recovery fees. This is documented in Canada Gazette, part II, volume 130, number 6, page 1114 and forward.

How is it in the public interest for Parliament to pass Bill C-28 and give Health Canada managers the legal authority to issue notices of interim marketing authorization based on secret data and seriously flawed--seriously flawed--risk assessment? These risk assessments are based on middle-aged men--middle-aged men--and we're supposed to assess the impact on children and the unborn? They are seriously flawed methodologies, but they are above all secret. The object, of course, is to speed up the adulteration of our food supply.

Madam Chair, and members of the health committee, you can't endorse what you can't scrutinize. You're being asked by Health Canada to endorse secret science and seriously flawed policies that jeopardize the health and safety of Canadians.

Therefore, we recommend that Bill C-28 be rejected in its entirety; that the minister terminate the use of interim marketing authority and return to performing his legal duties under the Food and Drugs Act; that the Minister of Health acknowledge the inconsistency between the Government of Canada's so-called smart regulation initiatives and its stated objectives of bringing Canada's health protection regulations in line with trade and investment policy, and his statutory duty in the Food and Drugs Act, which is to protect Canadians from health hazards and fraud; and finally, our fourth recommendation, that the health committee examine the circumstances surrounding the firing of the three Health Canada scientists from the veterinary drugs directorate immediately prior to the drafting of this proposed legislation and after they refused to issue MRLs for known carcinogens.

º (1650)

The Canadian Health Coalition is of the view that the current public inquiry into corruption in the sponsorship program will pale in comparison to what a public inquiry into Health Canada's regulatory approval system for therapeutic products, food additives, chemicals, pesticides, and veterinary drugs would bring to light.

Thank you very much for this opportunity to share our concerns with you.

º (1655)

The Chair: Thank you, Mr. McBane.

Our second witness is from the Canadian Labour Congress, the national director, Mr. David Bennett.

Mr. Bennett.

Mr. David Bennett (National Director, Health, Safety and Environment Department, Canadian Labour Congress): Thank you, Madam Chair.

On behalf of the offices of the Canadian Labour Congress, I would like to thank the committee for inviting us to testify on this important environmental health issue.

One of the main aims of the government's smart regulation program is to harmonize Canadian standards with those of the U.S. In Bill C-28 there is no statement of the purpose and the function of the amendments, so the best assumption is that the government intends to implement smart regulation in the areas of industrial chemicals, veterinary drugs, and pest control products occurring in foods as maximum residue limits.

For these items the minister has the power to issue interim market authorizations, introducing or amending existing Canadian standards. There is no consultation period prior to the introduction of such changes. The interim standards last for two years unless the authorization is cancelled or unless the interim standards are replaced by regulations.

We would like to draw the committee's attention to the huge change in public policy occasioned by a short and cursory bill. The limitations on the use and occurrence of food residues and veterinary drugs are there for a very good reason: to protect the health of the public, as well as that of animals, from products that are harmful or detrimental or that constitute a risk to human health. It is not as if the current regime imposes arbitrary limits to be replaced by authorizations that are equally arbitrary. It is for good reason that the Food and Drugs Act refers to the presence of these items in food as adulteration.

In order for the act to continue to be protective of human health, the limits should only be changed after full scientific consideration and the usual public consultation.

The first thing that both the committee and the public have a right to expect is that there be a statement of the purpose and function of the interim authorizations. If harmonization with the U.S. is indeed the purpose of the bill, it should be so stated. We would then need a rationale for the interim authorizations.

Harmonization should be a two-way street and not just the adoption by Canada of U.S. standards, in some cases a downward harmonization for Canada. In order for harmonization to take place in any way that's not simply arbitrary, we would then need a scientific rationale for issuing an interim authorization. It may transpire that the Canadian scientific rationale is similar to that of the U.S, which would be the best possible grounds for harmonization.

Without these provisions, Bill C-28 amounts to a huge unwarranted and arbitrary change in public policy, nullifying the rational grounds for a policy that protects the health of the Canadian public.

The essence of our presentation concerns methodology, the scientific procedures that form the rationale for a regulatory decision. Methodology is necessary for harmonization with the U.S. We should harmonize methods, not merely declare that foreign standards are now the legal standards of Canada. Methodology is needed for market authorizations. It is not enough to declare that 82 unlawful acts are now lawful.

With respect, we believe this committee should not accept a bill without a statement of purpose within it as to why interim market authorizations are needed, and further, it should not accept a bill without a scientific rationale for deviating from established public policy.

In other words, if you want to harmonize, harmonize methods; don't harmonize the results of scientific inquiry. All the Government of Canada would then be doing is simply saying, in an arbitrary fashion, that from now on the limits are going to be American limits. There would be no consideration whatsoever for public health and for scientific methodology.

So in conclusion, we propose, as minimum conditions of a viable bill, that, one, the purpose and function of the amendments should be explicitly stated; two, the scientific rationale for interim authorizations should be stated; and finally, proposed interim authorizations should be subject to public consultation through the Canada Gazette, parts I and II.

» (1700)

The Chair: Thank you, Mr. Bennett.

We have three people as individuals. I don't know if you have one spokesperson or if you each wish to speak.

Mr. Chopra, could you advise me?

Mr. Shiv Chopra (As an Individual): Madam Chair, thank you.

Generally the three of us come as a package; therefore, I'll take the liberty, with their advice, to make the opening statement. We are then each one open to questions.

The Chair: Thank you very much.

Go ahead.

Mr. Shiv Chopra: Thank you for inviting us, Madam Chair and members.

We are scientists possessing decades of inside experience and knowledge while regulating veterinary drugs at Health Canada. What we intend to communicate is that the whole of this renewal process should be postponed until after a public inquiry into approximately 15 years of our outstanding complaints regarding government “pressure” to pass or maintain drugs and other products and methods of questionable safety that are being applied to food production, and with a track record of harm to the public interest. The pressure we speak about has many times been alleged by us publicly to be coming from the Privy Council.

In requesting the said public inquiry we have consistently been supported by our union, the Professional Institute of the Public Service of Canada, by the National Farmers Union, the Council of Canadians, the Sierra Club of Canada, Sierra Legal Defence Fund, the Canadian Health Coalition, Beyond Factory Farming, and numerous other public interest groups.

To exemplify what we're talking about, Madam Chair and members, feeding cows to cows can produce mad cows. Feeding mad cows to people can make them face undue disease, death, and economic disaster. Much the same or worse effects are known to occur when various species of food-producing animals are raised with undue administration of carcinogenic agents. Carcinogens in food increase cancer, and undue antibiotic treatment of food-producing animals cultivates antibiotic-resistant bacteria in animals that become killers of people, with nothing left to cure them.

Regrettably, Canada has been in this situation for the last many years, and scientists urging government to avert it have either faced deaf ears or faced dismissal from their jobs. We three scientists here, after years of blowing the whistle on these things, were dismissed on July 14, 2004. The orders to dismiss us have since then been publicly endorsed by the present Prime Minister, and we are currently being fought against with huge funds of public money. We consider the situation to be not only deplorable, but it is corruption of the highest order in our country.

We also feel that Bill C-27, which is a companion bill to Bill C-28, which the current Parliament is considering passing, will turn an already bad situation into a far worse ill effect for the public interest. We strongly recommend that both these bills be postponed, to allow a duly open public debate in conjunction with the scientific community.

I should add that two of the witnesses you've just heard before this panel were partly responsible for our firing and that we have evidence to show that.

I should also say, referring to the presentation you heard before us, that you were told that “zero veterinary drug” was approved on an interim list. In fact, all antibiotics, all hormones going into Canadian food production have been in the interim status for the past 30 to 35 years. There's correspondence from the CFIA to Health Canada going back to 1998 asking Health Canada to give them the safe limits for these products, because otherwise they would apply zero limit.

Now Health Canada's response is that for products such as materials that cause cancer they will change the “maximum residue limit“ to “administrative maximum residue limit”. In fact, if you go to their website you'll find they're saying there's no difference between the two, except that this regulation has not yet been promulgated.

» (1705)

If they are working on those kinds of regulations at Health Canada and Parliament does not know about it...and you as a committee of Parliament are about to pass legislation without knowing what the regulations will be, when you in fact know that all these products are in our food supply and they are the killers on both counts—antibiotics and hormones. They have been in our food supply for the past 30 to 35 years, and we, the scientists, have been saying, please address this issue.

Thank you very much.

The Chair: We will go now to questions and answers.

I understand that Mr. Fletcher and Mr. Merrifield will share the first 10 minutes.

Mr. Fletcher, I will let you know when five minutes is up. Please go ahead.

Mr. Steven Fletcher: Can you give me a one-minute warning?

The Chair: At the four-minute mark, yes, I can.

Mr. Steven Fletcher: Quickly, I wonder if this set of witnesses would acknowledge, or maybe not acknowledge, that there would be a need for an MRL and if the intent is at least good to try to expedite the process. Or is that just out of the question?

Mr. Shiv Chopra: No, the MRL regulation already exists. It's the maximum residue limit that humans can tolerate in their food.

The Chair: That's not what he means.

Mr. Steven Fletcher: Yes, I meant the ministerial permit, IMA.

Mr. Shiv Chopra: As I said, now they're saying they're going to change the definition of maximum residue limit to administrative maximum residue limit.

When we're talking about causing cancer, then there can be no maximum residue limit that you can determine, because a single molecule of a carcinogen can attach to a single cell in the body and cause cancer.

Mr. Steven Fletcher: Yes, but the IMA, which is....The intent is to expedite the process when there's a lag time between going through the normal procedure.... Are there circumstances in which you can foresee that this would be a valid mechanism?

Mr. Shiv Chopra: I can answer the question the other way around.

Bovine growth hormone would have been in that situation. Today we would have had bovine growth hormone in Canada if we, the scientists--we three scientists who were parliamentary witnesses--had not intervened and blown the whistle. Then BGH would have been approved in Canada, because it was already approved in the United States, and then it would also have been approved in Europe. Because of what happened in Canada, then the European Union also disallowed, in fact banned, its use after having received a recommendation to approve it.

That's one critical example to show you what can happen.

Mr. Steven Fletcher: Sure.

Madam Chair, I hate that TLA, the three-letter acronym. That could explain my confusion earlier.

The Chair: Perhaps I could help you. You wanted to ask about “interim”. But did you read in the report that there is such a thing as “temporary”, which apparently is legal. There's no need to fix the act to carry on with those. So maybe you could....

Mr. Steven Fletcher: Okay, I'll do that.

I know I'm running out of time here. so I want to ask one question.

You were in the room, I gather, when I was asking Health Canada about the possibility of political influence on the process one way or the other. I gather from what you have said that you may disagree with what Health Canada presented to this committee.

Mr. Shiv Chopra: In fact, we have said many times that the pressure on us to pass or maintain drugs of questionable safety has been coming to us from the Privy Council, and the Prime Minister has endorsed our firing. Some of the witnesses you heard today were partly responsible for getting us fired.

On mad cow disease, for example, we have correspondence showing that. We said, don't do this, do that; and then they said, no, you're scaring the public. Now, if that's the kind of political pressure that...and saying “Do not share this information with anyone, even among yourselves”. Karen Dodds is sitting here, and she's the one.... I have correspondence here telling us not to do so.

You have Dr. Mayers appearing before you. He promised the public that on food irradiation he would go out and consult with the public before they changed the regulation. Now apparently they've changed their mind. This is the kind of interim or temporary approvals they're talking about.

» (1710)

Mr. Steven Fletcher: Okay.

Well, I think I'm running out of time here, but I would ask if my colleagues, when they're asking their questions.... There seem to be two issues here. One is the political interference and the validity of having these temporary permits. I'd be interested to probe that a little bit more. Unfortunately, five minutes doesn't allow me to do that.

The Chair: Thank you, Mr. Fletcher.

You've had your five minutes, Mr. Fletcher. Now it's Mr. Merrifield's turn.

Mr. Rob Merrifield: My suggestion is, are you suggesting to this committee that the Privy Council is telling Health Canada to move the regulations artificially and endanger the lives of Canadians? Is that what you're saying?

Mr. Shiv Chopra: We can only speak about ourselves. If the Privy Council is telling us to do certain things, if the Privy Council says expedite this, this is now the endorsement of all of this. And then going up to Parliament...and the Prime Minister is the head of the Privy Council,. Ultimately, we come down here and we get fired, and the Prime Minister says, well, that's okay, and we're in court. How can the Prime Minister be saying that he accepts Health Canada's word when we are fired?

That's the kind of political thing we're talking about.

Mr. Rob Merrifield: Do you have any documentation? Do you have any information you can give us?

Mr. Shiv Chopra: For example, we wrote to the Clerk of the Privy Council saying that there is a need for us to meet, or that there needs to be a public inquiry, and they replied back that, no, that is not going to be done.

Mr. Rob Merrifield: On the growth hormones, this is the one that is injected into the milk, right? This is what you're talking about?

Mr. Shiv Chopra: No, not only in the milk. Growth hormones are in meat as well.

Mr. Rob Merrifield: You're talking about growth hormones that are being used in--

Mr. Shiv Chopra: In meat production, in beef.

Mr. Rob Merrifield: --meat production as well.

Mr. Shiv Chopra: And, by the way, those are approved. Those are there. Those are in your food now.

Mr. Rob Merrifield: Yes. I realize that. The one that really concerns me is this animal to animal. You're suggesting that, as scientists, you told Health Canada not to allow animal-to-animal feeding in ruminant animals.

Mr. Shiv Chopra: We wrote in an open letter to Prime Minister Chrétien back in 1997 that BSE, mad cow disease, could occur in Canada.

Mr. Rob Merrifield: In 1997.

Mr. Shiv Chopra: Yes, in 1997.

Mr. Rob Merrifield: But that's when the protocols were set.

Mr. Shiv Chopra: Yes, and we wrote, please ask the Minister of Health to sit down with us or talk to the president of our union, and nothing happened. When the disease first occurred in Canada, when it occurred in the first cow, we wrote to the assistant deputy minister, Diane Gorman, and a week or ten days later we wrote to the Minister of Health, Anne McLellan, saying, “Now that it has happened, please do what Europe has done; do not feed any animals to animals, and the disease will stop immediately”. In fact, after that we were all suspended by the department, and Karen Dodds wrote to us, saying--we have the correspondence--do not talk about it.

Mr. Rob Merrifield: Yes, but did we not set up those protocols in 1997, animal to animal, ruminant?

Mr. Shiv Chopra: That's completely wrong.

Mr. Rob Merrifield: We did not?

Mr. Shiv Chopra: That's false. There was an advisory to the farmers by choice or the feed mills; that's how it has been going on. Blood is still continuing to be used. There are various other things in the system. So no, it hasn't been done.

Mr. Rob Merrifield: I might want to challenge that to some degree, because my understanding is that the same protocols.... Was the protocol the same in the United States?

Mr. Shiv Chopra: If you ban something, if you say there's a speed limit on the highway and you don't have any policemen giving tickets, then that's not a ban.

Mr. Rob Merrifield: Okay. I understand what you're saying. You're saying that it was a strong recommendation but there was no enforcement of it, so we couldn't verify that it was actually being done. Is that what you're saying?

» (1715)

Mr. Shiv Chopra: Exactly.

Mr. Rob Merrifield: But actually the recommendation was to stop feeding at that time, animal to animal, ruminant.

Mr. Shiv Chopra: You can make a recommendation, but when it's causing death of people--that's the potential--and you're ruining the whole agricultural beef industry in Canada, then you don't just recommend.

If we are putting a ban on Brazilian beef on the assumption that they may be doing what others are doing, which in fact Canada was doing, and then we ban their beef, but we're not taking care of our home situation.... That's what happened.

Mr. Rob Merrifield: I have a feeling this will go on for some time. I understand a lawsuit was filed--was it yesterday?--and I'm sure this is going to take some time to work out. I applaud you for the work you're doing.

I want to get back to some of the comments that were made by Mr. McBane, I think it was, with regard to GMOs. Do you have any verification that GMO products are harmful to the people of Canada, those that have been approved up to this time?

Mr. Michael McBane: Mr. Merrifield, I think that's the problem. We heard the departmental officials say several times that they haven't seen any evidence of harm.

Mr. Rob Merrifield: I know, but you made an accusation that there was harm, and I want to see your evidence that any GMOs that are on Canadian food shelves--

Mr. Michael McBane: No. What I said was that with GMOs it is impossible to do an assessment of safety. That is what I said.

Mr. Rob Merrifield: My time is gone, but I don't think you can answer that question.

Thank you.

The Chair: Next, Mr. Savage.

Sorry, Mr. Ménard. You're next.

[Translation]

Mr. Réal Ménard: Thank you, Madam Chair. You nearly passed right over me. Fortunately, I'm paying attention.

First of all, I'd like to remind the witnesses that the Bloc Québécois tabled a motion, which had the support of all parliamentarians, requesting that you appear—I belive that will happen at the end of May—to discuss your experiences at Health Canada. Clearly, that is not the purpose of today's meeting, but you can rest assured that we will closely scrutinize the events that took place.

I'd like to get back to Mr. McBane's statements and recommendations. You recommended, sir, that the committee reject the bill altogether. In your estimation, no amendments could make the bill palatable.

Am I correct in understanding that basically, you believe that for the sake of trade considerations...? Is it a matter of aligning ourselves with the United States in order to fast-track products to market when all of the studies have yet to be completed? Could you be more specific and give us some examples?

Mr. Michael McBane: I forwarded to all committee members an excerpt from the Food and Drugs Act. I'll explain things in English.

[English]

It's important to look at the text of what is being changed in the law. I would submit that when you look at section 4 of the Food and Drugs Act and you look at proposed subsection 4(2) in Bill C-28, you'll see they are standing the minister's statutory duties on their head. Section 4 of the Food and Drugs Act declares that no one shall adulterate the food. Proposed subsection 4(2) is saying food adulteration is permitted and here's how we're doing to do it, through MRLs with no scientific assessment, because you can't establish a safe level of carcinogens.

So you can see the purpose is completely changed. The core mandate of the minister would no longer be to protect health from hazards and fraud; it would be to expedite the adulteration of the food supply. I could not think of a more radical change to the Food and Drugs Act. This is not a technical matter, and the text before you shows a huge change.

[Translation]

Mr. Réal Ménard: For example, do you see any link here with American interests?

[English]

Mr. Michael McBane: My colleague Dave Bennett has mentioned that as well. He can add to this, that the broader agenda is of course harmonization of regulations. That's in fact a declared objective of smart regulation. We are harmonizing with the Bush White House, which has no floor to how low it's willing to go in food safety.

The consequences? Our food is becoming dirty. We have lost the European market. We have lost the Japanese market. The question is, do we want to trade in high-quality, value-added, safe products free from carcinogens like hormones, or do we want the dirty American market?

We should at least have a discussion and not foreclose on our markets, and that's what we're talking about in terms of the implications of harmonizing with the Americans at a time when there's a great unravelling of the public health protections in Washington. That is the objective, and it will ultimately destroy the sovereignty of this country in terms of its health protection legislative framework.

» (1720)

[Translation]

Mr. Réal Ménard: As you well know, I'm concerned about anything that could potentially compromise a country's sovereignty.

Getting back to the position taken by the scientific community, you say that you have been making representations since 1997 because, in your opinion, antibiotics have already made their way into the food chain and you're concerned about the long-term effects.

The link between the Privy Council and your statement is somewhat suspect. Obviously, the Privy Council is the Prime Minister's department. However, does the Prime Minister examine every single matter which comes under the responsibility of the Privy Council. I'm not so sure we can make that assertion.

Please elaborate further on your statement concerning antibiotics and the Privy Council.

[English]

Mr. Shiv Chopra: Let me take the antibiotic issue first, because we have dealt with the hormones and cancer.

For antibiotics, if you determine the maximum residue limit, then you say they are safe. In fact, it doesn't do anything. The maximum residue limit of an antibiotic in food is only to protect some individuals who may be allergic to that particular antibiotic, so if that person swallows that antibiotic, they don't suffer an allergic reaction.

However, that's not the major harm of feeding antibiotics to animals. What happens when you give antibiotics to animals, any kind of antibiotics, is that then those animals produce antibiotic-resistant organisms in their gastrointestinal tract. Those bugs, once they become resistant, now become so resistant that they are resistant to five, six, seven, eight, or all antibiotics that are available. As a result of that, those resistant organisms, some of which are pathogens not to animals but to people, like MRSA or Clostridium difficile, spread to people in hospitals and start killing people. That is how it happens with antibiotics.

We have been saying that these very drugs have been in our food supply for a very long time. When I say “long time”, I mean the questions about this go back to 1969 or to when I was a graduate student at McGill, from 1960 to 1964. That's how far back this issue goes.

So what we--

[Translation]

Mr. Réal Ménard: Please get back to the subject of the Privy Council, otherwise the Chair will cut you off.

[English]

The Chair: No, no. You're well over your time, Mr. Ménard. I'm always generous--too generous--to you.

Mr. Shiv Chopra: So very quickly, coming back to the Privy Council, we--

The Chair: No, Mr. Chopra, Mr. Ménard's time is up. We have to move on to someone else.

We have two to handle here.

Some hon. members: Oh, oh!

The Chair: Mr. Savage.

Mr. Michael Savage: Thank you, Madam Chair.

I wonder if I could just ask Mr. Bennett this, first of all. Is it normal for the CLC to advocate on a position such as this, a health issue? Is that a normal thing?

Mr. David Bennett: Yes, it is normal, though it has to be said at the same time that the range of environmental health hazards the Canadian Labour Congress has addressed has increased in the past decade. We've got authorization for and have just started a healthy food campaign.

Our representations about the regulatory regime and food safety legislation are to some extent a new departure for the CLC; however, the rationale for it is very similar to that for our approach to environmental hazards, to workplace carcinogens, for example. So it's an extension of the areas we cover, but it's not an extension of the approach to public health we've taken for other environmental and workplace hazards.

Mr. Michael Savage: I just want to ask this, and I'll open this to anybody on the panel here. There's been some discussion and it appears you're not supportive of the bill, but there's also an issue of process here that has been mentioned. Can you provide for me what you think would be a process to implement a protocol like this, keeping in mind that it's really already happening anyway? What should be the process for that?

Maybe I'll start with you, Mr. McBane.

Mr. Michael McBane: I think the first item of business is to ask why senior managers at Health Canada systematically ignore the advice of the Auditor General to clean up the regulatory system, especially on pesticides management. The department completely rejects the findings of the Auditor General on pesticides management.

What I'm arguing is that there's no need for an interim authorization authority. I'm not interested in trying to facilitate a shift in the legal mandate of the minister. This of course is legislation, so we would rewrite the minister's mandate and change the purpose from protecting us from adulteration to facilitating a quicker access to the products.

» (1725)

Mr. Michael Savage: I wonder if anybody else has a thought about process.

Mr. David Bennett: Yes. The thrust of our presentation is that, with respect, the committee should not simply be authorizing changes in standards. The committee should be authorizing an explanation of the methodology and an explanation of the purpose of these amendments to the Food and Drugs Act that are before you. And we believe this is a minimum condition for such a big change in public health policy--something that's been underlined by the Canadian Health Coalition--but, Madam Chair, if you do this, what you are really doing is inviting a whole range of procedures, a discussion of scientific rationale, and the relationship between science and policy, which is a huge great issue.

The reason we haven't had this public debate is the complete secrecy in which the regulatory agencies and departments on pesticides, drugs, food, and industrial chemicals conduct their scientific deliberations, the way they relate science to policy, and the decisions they come up with. Without this open public debate, we don't believe legislators can make a proper and informed decision about a change in public policy of this sort.

One of the implications is that this committee--and by implication, the government--should be demanding that there be a completely open process so that we know how decisions are made, so we have access to the information on which regulatory decisions are based, and so we can see displayed in public view the way that governments operate. To receive assurances from qualified scientists at senior management levels that we're doing this properly and we're doing it in the public interest, nobody should have any confidence that in fact regulatory decisions are being made properly.

Mr. Shiv Chopra: If I may be allowed to add something quickly, I think Madam Chair asked the question aptly with those long, technical names. On the process for making regulatory change that involves very heavy scientific content, the only way to do it is to bring the discussion among scientists in front of you, in front of the public, in a very simplified terminology. I think Parliament should be encouraging that.

If you have your own research funds, put them out there. If you don't have them, ask for them, and let public debate occur in front of you, among the scientists. Don't say So-and-so can talk because he or she is ADM, and you cannot talk because you work under that person. I think this is what's killing the whole system.

My colleagues may want to make a comment on that. It's a very important question.

Ms. Margaret Haydon (As an Individual): It's been the management policy now...at least, our observations are that the senior managers don't have the scientific knowledge, so if we express our concerns, they can't even understand it, let alone bring it up the chain of command to the minister.

The Chair: Thank you, Mr. Savage.

I'm going to have to ask the committee, as this is the usual hour of ending the meeting, can I have a show of hands of those people who would like to continue for another, say, 15 minutes?

Mr. Steven Fletcher: I have a point of order.

The Chair: Yes.

» (1730)

Mr. Steven Fletcher: We're going through clause-by-clause on Thursday, but I still have many more questions.

The Chair: Yes. We don't have to go to clause-by-clause. But the point is that we have this group assembled now. My question is, would you like to go at least until everyone has had one chance at a round of questions?

Mr. Steven Fletcher: I'd like to have another shot at Health Canada.

The Chair: Well, you noticed at the end of their testimony that I suggested to them we might want them back, and we're not bound to move forward on this schedule. This was a tentative schedule, and if you would like to bring Health Canada back, we can do so, or maybe add some other people from Health Canada as well.

I think I saw a majority of hands up for those people who would like to stay to finish the questioning. Is that all right with our guests? Thank you.

We will continue, then. Those people who have other commitments can feel free to leave.

I think the next speaker is Ms. Crowder, and then it's Mrs. Chamberlain.

Ms. Jean Crowder: Thank you, Madam Chair.

I'm going to preface it with a couple of comments. One is that the Auditor General's report from 2003 specifically talks about heavy use of temporary regulations in approving pesticides, the fact that there are scientific uncertainties and inconsistencies and gaps in information, that in 2001-02, 58% of all permits were temporary—and on and on. When we start to talk about temporary permits and interim measures, it seems there's a great gap in information.

The next thing I want to quickly comment on is the Smart Regulation executive summary of September 2004, which was issued by the External Advisory Committee on Smart Regulation. It says there, of Canadians:

From an international perspective, they are generally in favour of greater cooperation, in particular through multilateral international bodies, and they will also support bilateral cooperation, including Canada-U.S. regulatory cooperation, if it means strengthened regulatory standards or if it represents a more cost-efficient way to achieve the desired results

You can't answer this, but my question was, “Oh, really? Whom did they consult with?” That's certainly not what we hear from the general public. I don't hear that people are interested in aligning our regulations with the U.S.

I wonder if you could comment specifically on whether or not you think U.S. regulations provide the level of confidence in food safety that we would feel comfortable with.

The second thing is, I wonder if you could comment specifically on your confidence in the current process we use to say that things are safe.

We could start with Mr. McBane and go through.

Mr. Michael McBane: Thank you for your question.

On the issue of what the Auditor General found in the pesticides management agency, in conversation the Health Coalition has had with a number of scientists in various branches of Health Canada we've been told that scientists do not know what level of human exposure Canadians are exposed to with pesticides currently. Yet we were told a few minutes ago by the department that the pesticides have had scientific assessment that has established no harm.

I would urge you to be very skeptical of those comments. They are not backed up with any evidence—the exact opposite, from the Auditor General.

We do not have the data on what the exposure is, so how can we say it's safe? We don't even have a methodology. Yet, for example, 2,4-D is being pushed out, in spite of the fact that the World Health Organization has said it exceeds the guidelines for all children under five. This is shocking, that even when there is scientific evidence of harm we're being told that safety has been established.

There is no credibility to any of these policies. We're being completely misled.

Harmonization with the United States, turning to your other question, is an extremely bothersome and serious situation. When you look at the Office of Management and Budget in the White House, which is in charge of regulations in the United States, it's full of conflicts of interest, where captains of industry are now taking over U.S. federal government regulatory agencies. There is no limit beyond which they're not prepared to go in making the world safer for chemical profits. They don't care about health. They'll say, “There's no evidence of harm”, when you're talking about things where they're not even studying the combined effects, for example, of the multitude of all these chemicals together. They don't even look at any of that, and yet they're saying that safety is assured.

Again, there's no science for any of this toxicology for the combined effects. We're really just being misled about smart regulation having no effect on safety. We'd have to be very naive to think that harmonizing with American regulation under the Bush White House would have no negative impact on public safety. That is not a statement that is supported by any evidence.

» (1735)

Mr. David Bennett: I'd like to take just one example in response to Jean Crowder's question, and that is the question of maximum residue limits for pesticides. There is an international body, not an agency of the United Nations, the Codex Alimentarius Commission, that lays down a table of maximum residue limits for pesticides in food. These limits are not health-based limits. They were constructed to help developing countries produce some food standards on agricultural grounds. So a crude way of putting it is that these are the lowest global limits that the authority thought was feasible in order to enable developing countries to grow crops without an impediment to agricultural production.

So let's be clear, these are not health-based limits. There is a tendency in Canada and the U.S. to adopt the Codex limits. However, the limits in the two countries differ to some extent from the Codex and they differ from each other. We should be very skeptical, as Mike McBane has pointed out, about adopting limits that are not health based and have no scientific rationale for their adoption--at least no scientific rationale on health grounds.

So when we come to harmonization of MRLs with the U.S., the tendency on the whole would be for Canada to harmonize downwards with the U.S. What would happen in practice is that wherever the U.S. has a lower limit, Canada would be expected to come down to it. So it's not really a question of give and take of harmonization; it's “adopt our limits”. Why? “Because we're the more powerful trading partner. That's why”. That is not a good health-based reason for harmonization.

But I would like really to go back and say there is a debate that goes behind this and beyond this, and that is, if we really want to have a debate about standards--harmonized or not--then you have to have a debate about the scientific rationale for choosing one limit rather than another. We in our Canadian way have always assumed that our rationales are better than the States because our standards are better than the States and so on. This presumption of superiority on the part of Canada I don't believe is well founded, and the net result would not be to the benefit of the Canadian public.

The Chair: Thank you very much.

Hon. Brenda Chamberlain: I have a question.

Mr. McBane, you talked about estradiol and you talked about the fact that breast cancer is related to that by 3%. Did I understand you correctly on that? How do you know that? How did you track that?

Mr. Michael McBane: That surprised me too. It came from a peer-reviewed scientific study. I have the reference in my notes here. I'll just look it up. Actually, better yet, I can leave you the reference. It's in published scientific literature in a recent scientific journal.

The Chair: Is that a 3% increase, or 3% of the cases were attributable? I don't know what that 3% means.

Mr. Michael McBane: Let me just find the reference here--estradiol's link to DNA damage, early puberty among girls and breast cancer in women: “the human epidemiological studies point to estrogen as a weak carcinogen adding approximately 3% breast cancer risk/year of estrogen exposure”.

» (1740)

The Chair: Does that mean 3% more cases or--? I don't know what that means.

Mr. Michael McBane: The thing about estradiol is that it exerts both tumour-initiating and tumour-promoting effects. That's why it's called a complete carcinogen. It causes other types of cancer as well, but the link to breast cancer is well established in the research findings.

It was published in the Current therapy in oncology, 1993, out of St. Louis. I can leave you the printed reference.

The reason I mention it is that there are 300 pages of peer-reviewed references in the study. So they can't say they don't know this. Yet they've given them an MRL for it and we're eating it in our meat.

Hon. Brenda Chamberlain: Then your feeling is that it should be pulled, is that correct?

Mr. Michael McBane: Absolutely, yes. We're not allowed to export our beef to Europe because of the hormones.

Hon. Brenda Chamberlain: Because of this hormone?

Mr. Michael McBane: Yes. This is a killer. The Europeans will not touch Canadian beef because it's laced with hormones. As I've said, there were about 65 to 70 DIN numbers, just with these six hormones, named by the EU as complete carcinogens.

Hon. Brenda Chamberlain: And how long has that been put into the meat?

Mr. Michael McBane: For 35 years, I guess.

The Europeans just recently found the problem; I'd say in the late nineties. They came and did an audit of Canada and found that meat for Canada's hormone-free program, for meat to be exported to Europe, had hormones in it.

Hon. Brenda Chamberlain: So this 3% level has been.... You're saying each year 3% more women develop breast cancer because of estradiol; is that what you're telling me?

Mr. Michael McBane: No. It's the exposure itself that increases the carcinogenicity by 3%. In other words, if you were disposed for cancer, this would be a 3% increase in the tumour initiation and tumour growth—just from estradiol.

Hon. Brenda Chamberlain: Not per year, though; you said “per year”, but it's not per year.

Mr. Michael McBane: It said per year of exposure.

The Chair: So the older you are, the more you're.... Every year is 3%?

Hon. Brenda Chamberlain: It's accumulative; is that what you're saying?

Mr. Michael McBane: I'd have to defer to the scientists on that one.

Hon. Brenda Chamberlain: That sounds almost impossible. I mean, it doesn't sound right to me. I just have to say that.

Mr. Michael McBane: Yes, well, that's why I'll leave you the study reference, so you can—

The Chair: Maybe Dr. Chopra can add to this.

Mr. Shiv Chopra: It means more and more people are getting exposed to it, because more and more farmers may be using that hormone in meat production, and more and more people are eating it, more and more countries are approving it. So overall, there's an additional 3% exposure of women to it; that's what it's saying. It doesn't say that cancer has increased 3% as a result, but exposure; therefore the potential for—

Hon. Brenda Chamberlain: It's the potential; it's not necessarily that they're getting cancer.

Mr. Shiv Chopra: The potential for causing cancer is increasing at that rate.

The Chair: And does it increase cumulatively? In other words, if you eat that meat when you're ten years old, and all of a sudden you're 50, then you have 40 years of cumulative exposure, and that increases your risk?

Mr. Shiv Chopra: And also, it gets worse in some—

Hon. Brenda Chamberlain: But you don't necessarily have breast cancer.

Mr. Shiv Chopra: No, but in some ways it's quite a dramatic effect. When you're going through puberty or when you're going through child-bearing years, then the potential of a particular cell catching that, or becoming cancerous, increases. That's what happens.

Hon. Brenda Chamberlain: Okay, thanks.

The Chair: Thanks, Mrs. Chamberlain.

Hon. Brenda Chamberlain: Mr. Merrifield is getting upset.

The Chair: But you know, Mrs. Chamberlain, you were at just over five minutes, and you often give up some of your time to your opponents.

Hon. Brenda Chamberlain: Even to Mr. Merrifield.

The Chair: Well, sometimes even to Mr. Merrifield, yes.

Mr. Lunney.

Mr. James Lunney: Thank you, Madam Chair.

Just for the record, I'd like to suggest that if we'd had the witnesses in a different order, we might have had a different set of questions for Health Canada officials.

The Chair: Yes. Mr. Fletcher suggested that perhaps we get Health Canada back on Thursday, and you may pick the people you want.

Mr. James Lunney: Excellent. I'm sure we have some further questions.

I simply wanted to say, first of all, that we're very glad to have you here as witnesses, and thank you for coming, especially our three whistle-blowers who were terminated after the election while all the members were away. We've been wanting to have you here at committee for some time and we're hoping.... I understand the date is set for April 19 for an in camera session. Most of us on committee are quite interested in having a good chat with you.

Also, Mr. Bennett just referred to the secrecy about the regulatory process and how as members we can't evaluate the effect of regulations if their information is kept in secrecy. The Canadian Association of Journalists last year, in 2004, voted Health Canada the winner of the fourth annual Code of Silence Award from the journalists, who said they recognized the most secretive government department in Canada annually and that Health Canada won hands down. Anyway, we think there are some concerns here.

I wanted to pick up again on the estradiol that was mentioned. There was some confusion about that 3% increase. Maybe it's a 3% increase of risk per year of exposure; that seemed to be the way it was expressed.

But putting that aside, one of the questions that were raised in Mr. McBane's report is, when Health Canada established an administrative MRL for estradiol, what level of breast and prostate cancer did Health Canada deem acceptable as a consequence? Do you have scientific evidence pointing to the increased risk for both breast and prostate cancer?

» (1745)

Mr. Shiv Chopra: I do not know of any specific figures that are published, nor can it be easily determined, because you're talking about cancer being caused from many sources. There are many chemicals in the environment. There are many estrogens. Many pesticides have estrogenic effects. Therefore, it is virtually impossible to determine, because it is a collective of so many chemicals, and a collective of the years of exposure and the age put together.

What's important to understand, though, if you will allow me one minute to expand on this, is that when risk cannot be determined, such as for cancer, the position the United States and Canada are taking officially is that we should shift from risk assessment to risk management--in other words, allow the risk to carry on for 30 or 35 years until people begin to die or get cancer. Then we'll go and look at the epidemiological information and do something about it.

If that's the solution...I wrote a paper in Health Canada about exactly that. All of us go through life taking risks. There are planes we fly, cars we drive; we live in homes that have fire insurance, and so on. Therefore, if the companies are going to be given these kinds of advance approvals quickly, then Parliament should ask the companies to put aside insurance money for that day when harm occurs, and then they should be paying for that from that insurance fund, or trust fund, or whatever, and not make the public pay again.

Mr. James Lunney: Okay, going on to risk assessment based on middle-aged men--somebody made a comment to that effect. I imagine that's what Health Canada referred to as a toxicological assessment, which they like to do. Of course, many pesticides interrupt the reproductive cycle, particularly for females, in insects and up through the food chain, but it seems that these hormones are similar in even the higher species, so it seems likely that females and children would be more vulnerable. We have issues here in Ottawa, where they wanted to ban the use of pesticides on lawns and so on. That got wiped out by fears over West Nile virus last year, and they went out and sprayed anyway.

I was quite surprised when you mentioned that all hormones and antibiotics have been in the intermediate...measures, I believe it is, for 30 or 35 years. I guess that would be since we had a temporary permit beforehand. Are you saying no safe levels have been established for antibiotics in meat or poultry, and so on--for 30 to 35 years they've been in a temporary permit arrangement?

Mr. Shiv Chopra: Exactly. Although antibiotics have been assigned maximum residue limits, those maximum residue limits per se do nothing for antibiotic resistance. Similarly, on the other side, for hormones there cannot be a maximum residue limit, because they cause cancer, and cancer can have no lower limit. Therefore, from that point of view, they've effectively been in that situation for the past 35 years. Having a maximum residue limit or administering a maximum residue limit effectively does the same thing. In other words, your food is totally contaminated with antibiotics, and those are the effects you're going to suffer in society.

» (1750)

Mr. James Lunney: Something came up earlier on animal protein in feed. That was to do with ruminants to ruminants, and so on. Technically, as you said, we're not supposed to be feeding ruminants--sheep and goats and cows--to cows, correct? I think I heard you say that without enforcement, how do we know it's not continuing? And it appears blood products and other forms are still finding their way into feed.

I have to ask you this. I was quite shocked when the head of the CFIA told me here it was all right to feed pigs and horses to cows. I personally—we're dealing with herbivores—have a little problem understanding how it's okay to feed animals to other animals if we're not looking to have a shift in virus load from one animal to the other when we give them feed that's not appropriate for their natural consumption, even if they're not ruminants, because every species has its own viruses.

Would you care to comment on that?

Mr. Shiv Chopra: Yes, certainly.

There's a big difference between viruses and bacteria, which are living organisms that cause disease. You can actually catch them. Prions are not in that same category. These are proteins that used to exist on the earth when the earth was a boiling cauldron and proteins were just being formed. Those proteins still have memory from 4.5 billion years ago, and they've add-on chains, because in evolution everything wants to be independent and also collective. Those proteins go berserk once in a while, and they cause what's called this kind of disease. Because it happened in cows, we call it mad cow disease, but it happens already in humans and pigs and other animals, which naturally die. If you now start recycling that protein, animal to animal, then you're concentrating that protein in that animal, and then that animal to another animal and so forth. If that protein is good for horses and pigs and chickens, why can't that protein be good for our sausages, and also for pepperoni and everything else? Then you'll eliminate the disease; you'll take care of the environment. A protein is a protein is a protein.

Mr. James Lunney: The last question is a quick one. It's on the peanut allergy that has suddenly appeared, with a lot of children developing allergies to peanuts. We have soy now. All of the soy grown in Canada is genetically modified, and I understand it's a peanut gene that's in the soy product. Is it possible there is a connection between soy product containing a peanut gene and peanut allergies?

Mr. Shiv Chopra: Well, anything can happen when you start injecting genes from species that are not supposed to mate.

For example, last week an incident occurred in Germany, where Bt corn numbers 10 and 11 got mixed. In Bt corn, 10 is the one that has problems, because into that 10 they've also injected a gene for ampicillin resistance. Now, imagine ampicillin antibiotic growing in your crops, in your corn. Actually, that comes from a bacteria. Now the two are mixed and they're multiplying in nature. This DNA is all over the place, and we could lose all our antibiotics that way.

Those are the kinds of things that can happen from genetically modified crops, and they also now want to produce drugs, pharmaceuticals, contraceptives, hormones, and antibiotics by growing crops that will be all over the place in the land. That's horrible, because God doesn't permit that. Ancient scriptures don't permit that; you have the Book of Leviticus. You have all these things before us. We think today we are smarter than ancient people. We're stupid if we allow them to do that.

The Chair: Thank you, Dr. Chopra, and thank you, Mr. Lunney.

Our last questioner will be Madame Demers.

[Translation]

Ms. Nicole Demers: Madam Chair, I won't direct my question to the witnesses, as I'm becoming increasingly confused. I have the feeling that I'm in the presence of two opposing camps: on one side, there are those who maintain that there is no danger, while on the other side, there are those who argue that the danger is imminent.

Since Health Canada maintains that there is no risk, I'd like it to turn over the list that it refused to hand over the Labour Congress, that is the list of 82 products for which interim marketing authorizations have been issued. Mention was made of this list earlier. I'd appreciate a copy of the list, along with the list of additives found in these products.

I'd also like to have a list of the 60 to 70 products that contain hormones and that have been given an identification number.

» (1755)

[English]

The Chair: I'll have the clerk ask Health Canada for that list of 82 additions to food, in both languages, to be as circulated as soon as possible.

[Translation]

Ms. Nicole Demers: I'd appreciate that, Madam Chair, because I'd like us to see the range of products on the list. I'm also wondering if the committee could possibly hear testimony from independent scientific experts who could explain the nature and uses of the products on this list.

[English]

The Chair: Certainly, based upon the conflict we heard today, it seems to me our plan for fairly short hearings for this should be set aside. I know Mr. Merrifield has asked that we have Health Canada back. We have a few witnesses who are coming on Thursday in the first hour, and then we'll have Health Canada in the second hour.

But I agree with you. I'd like to hear from some independent university researchers or people like that who are not funded by either Health Canada or, say, agricultural or pesticide producers or anything like that, so we can get some independent testimony.

Is that all you had to say?

[Translation]

Ms. Nicole Demers: Yes, Madam Chair. Thank you.

[English]

The Chair: Thank you very much.

On behalf of the committee, those who are still here and those who have left....

Yes, Mr. Lambert.

[Translation]

Dr. Gérard Lambert (As an Individual): There's one more thing. We need to consider one thing if we're planning to harmonize our veterinary drug regulations with US regulations. In the U.S. the regulations allow for the presence of carcinogenic substances in animals intended for food. That's not the case in Canada. That complicates matters considerably. We need to be very cautious when we talk about harmonizing Canadian and US regulations. The fact that cancer-causing drugs are approved for use in food animals is quite telling. The two approval systems are quite different.

Take hormones, for example. Estradiol was approved, but production methods are different. Hormone levels in Estradiol are comparable to those in a young boy, that is they are quite low. These levels were determined by establishing a daily level of Estradiol production. The US regulations...

[English]

The Chair: Dr. Lambert, the question on the harmonization of standards between Canadians and Americans is really not on the table today. It has come up as a side effect and was actually introduced by a person from Health Canada. I must say that the whole question as to the wisdom, or lack thereof, of moving on harmonization may be coming from somewhere up there, but this committee has certainly never considered it and we have never given any kind of push to do it. It's a sidebar to this other issue.

Dr. Lambert, if you want to make a presentation, you always have to make it at the beginning of the meeting. You can't make your little presentation at the end, unless it's an answer to a specific question. Madame Demers, who was the last questioner, didn't really have a question.

It's half an hour beyond our closing time, and most of us have to be somewhere in about a minute. I'm going to have to close the meeting.

Thank you very much to all of you for coming.

Thank you to my colleagues and staff, who have given us an extra half an hour here. Thank you very much.

This meeting is adjourned.