Agriculture Committee on April 1st, 2008

[Guy Lauzon, Conservative, Stormont—Dundas—South Glengarry, ON]

Thank you very much.

I think you mentioned the magic word—or which we like to think is the magic word—“dialogue”. You mentioned dialogue with the industry, and obviously you're mentioning dialogue with the pharmaceutical industry, but I'm assuming—and I better be correct here in this assumption—that you're dialoguing with the agricultural industry too. The whole idea is that everybody has to work on the same page here, because if we're not, obviously other countries are going to be eating our lunch on the world market and we won't remain competitive.

So are the producers, for example, part of the dialogue? Are they part of the solution?

[Dr. Siddika Mithani]

Yes, they are. We have just set up an external advisory committee—a joint committee with CFIA and Health Canada—to look at some of the strategic directions in which we need to move to satisfy the regulatory requirements, health and safety, and competitive issues such as cost. Livestock producer associations are also involved. We have the Canadian Cattlemen's Association in that expert advisory committee, along with the Canadian Pork Council. In our task force, we talked about personal-use importation. The key issue was the price differential, which is a big issue for the farming industy. We've also consulted with provincial organizations. We've had the livestock producer associations involved in order to provide us with recommendations on strategies that will allow us to balance health and safety with some of the competitive issues we are seeing as we move forward.

[Guy Lauzon, Conservative, Stormont—Dundas—South Glengarry, ON]

So you can reassure this agriculture committee that the producer is at the table giving you input on the solution and the concerns. That is extremely comforting.

In your presentation you mention that in the overall action plan “Health Canada evaluates and monitors the safety, quality and efficacy of veterinary drugs. The Department also promotes the prudent use of veterinary drugs administered to food-producing animals”—which is something I'd like to take a second to clarify. You go on to say in another part of your talk: “A new veterinary drug is approved for sale in Canada only if Health Canada is satisfied that...it does not leave potentially harmful residues that could pose undue risks to humans eating food products from treated animals.” Then you say that “Health Canada plays a critical role in establishing maximum residue limits...”.

Can you explain how the consumer can be confident that, for the product they are eating, you have guaranteed that the maximum safe residues haven't been exceeded? You mentioned “prudent residues”. Can you explain that a little further?

[Dr. Siddika Mithani]

I'll try to explain it in two parts. Maximum residue limits are based on basic toxicology studies. These look at the product metabolized in the animals and make extrapolation calculations. Toxicity studies in animals are considered. They study the maximum tolerance, the maximum areas where there may be issues. For example, they take into account carcinogenicity and mutagenicity studies to ensure that a person who eats food treated with those particular drugs will not be subjected to levels of exposure that would cause harm in the long term. These types of calculations, these types of study requirements, are internationally harmonized. Therefore, Canada is not asking for any more than what is there internationally.

There are also international organizations such as the Codex Alimentarius Commission that bring people together to talk about where to draw the line in terms of safety, what the maximum limits are. When you look at the maximum residue limits that Health Canada has set for a lot of these veterinary drugs, they are very specific, and they are internationally harmonized.

[The Chair, Conservative, James Bezan]

Thank you.

Mr. Atamanenko.

[Alex Atamanenko, NDP, British Columbia Southern Interior, BC]

I have a couple of questions from someone who has contacted our office, Dr. Mithani.

What is the product rBGH, used by folks in the dairy industry? What is that? Is it being used? Is it something to do with a growth hormone in the milk? I'm not sure what it is. Could you answer that question first?

[Dr. Siddika Mithani]

I would imagine it's rBST that you're talking about. It's a drug approved in the U.S. It hasn't been approved in Canada. Obviously the concern when we looked at this particular drug was not human health but concern in terms of animal health. Therefore, the drug was not approved for use. The drug is also not approved for use in Europe and many other countries.

It's very important to remember that the door is always open for industry to come in with studies that will justify why the concerns Health Canada has raised can be alleviated. So as a drug company, if you were developing rBST or any other drug, you would file a submission. We would provide you with comments as to the reasons this particular product is not approvable and that additional studies would be required, or for you to be able to justify the rationale for that particular drug to be on the market.

Therefore, at this point in time, rBST is not a product that's approved for use in Canada because of animal health concerns, certainly not human health concerns. But there is no reason why, if the company had additional studies to justify our having a rethink, a re-examination of the information that's available, there wouldn't be an opportunity to reconsider any submission, not just rBST.

[Alex Atamanenko, NDP, British Columbia Southern Interior, BC]

Am I right then in assuming that when we refer to there being no growth hormones in our milk, that is what that is?

[Dr. Siddika Mithani]

That's right, no artificial growth hormones.

[Alex Atamanenko, NDP, British Columbia Southern Interior, BC]

So that's really also a human concern.

[Dr. Siddika Mithani]

It really depends. If you go back to the decision that just came out yesterday regarding beef hormones and the WTO challenge, clearly our decisions are based on sound science and the information we had reviewed on the issue of beef hormones. We came to the conclusion that based on the MRLs we really didn't see a human health concern or an animal health concern. With rBST, clearly the studies actually did not show a clear sign in terms of animal health concerns, so that still is an outstanding issue with the rBST.

[Alex Atamanenko, NDP, British Columbia Southern Interior, BC]

Thank you.

The other question this person has is in regard to antimicrobial resistance. Apparently this issue is being handled, according to her, very slowly by VDD. Could you comment on that, please?

[Dr. Siddika Mithani]

I think antimicrobial resistance is an international issue. Everybody is concerned about antimicrobial resistance. I'd like the committee to note that we have, with the Public Health Agency of Canada, something called CIPARS—“Canadian Integrated Program for Antimicrobial Resistance Surveillance”. There is a mechanism by which we look at antimicrobial resistance. Every antibiotic that is approved for use in Canada will go through a risk assessment, and we'll talk about the appropriate use of this product, to ensure that we are not developing antimicrobial resistance. There is a lot of international activity as well. Health Canada is right now chairing an international committee on antimicrobial resistance. So this is not only a Canadian issue, it's a global issue, and it's being dealt with as we move forward.

[Alex Atamanenko, NDP, British Columbia Southern Interior, BC]

Thank you.

The research paper talks about the Canadian Animal Health Institute, and they were the ones my colleague referred to in speaking of the difference in approval times between two years and five to eight and a half years. You mentioned that the backlog is being cleared up. Would it be safe to assume that by the end of 2009 we will also have a two-year approval process, as opposed to five to eight and a half years, as it is now?

[Dr. Siddika Mithani]

Absolutely. I'm very confident in that, once we get rid of the backlog. We are putting process improvements in place right now, whereby industry can come in earlier. We are having dialogues with livestock producers about the generic products that are available in the U.S. We can encourage those companies to come into Canada and file their submissions. Our priority for next year is really looking at generic submission guidelines, so that we are not asking for any more than any other country in terms of regulatory requirements. I think we are really looking at a situation whereby, if we can get industry to come and file their submissions, we certainly will have a very competitive market.

[Alex Atamanenko, NDP, British Columbia Southern Interior, BC]

Thank you.

Lastly, the Animal Health Institute once again gives us reasons for some of the problems, and I'd like you to clarify this, because I don't understand it.

It's right here in front of me. They say, “Risk acceptance has declined within the VDD leading, in some cases, to risk aversion.” I don't understand what that means.

[Dr. Siddika Mithani]

Again, I'm not here to interpret what CAHI is saying, but I think science has evolved. I think the processes that we have in the veterinary drugs directorate have also evolved.

I'd like to give you one example. In 20 years, we've never had the approval of a product at the first round where a manufacturer files a submission. It is always three or four years later that a letter goes out with deficiencies. This year, two drugs have been approved at the first cycle, so there has been a considerable improvement.

Some of the improvements are not in terms of looking at risk aversion and risk assessment but really being able to go out and get the expertise to help us in providing us with recommendations. One of the process improvements that we've implemented as we've moved forward is that when there are issues that are scientific in nature where there isn't the expertise within the veterinary drugs directorate, we've partnered with the CVMA, the Canadian Veterinary Medical Association, to identify experts in the field so that we can bring in a panel of expert advisers who will help us identify and address the issues that come in these submissions so that we can move forward.

I'm sure that's coming from the IFAH report, or part of it is coming from the IFAH report, but some of the processes we've put in place will help us move forward. Some of these strategies are really going to help us in bringing that balance between health and safety and being able to do those risk assessments. There's no sense in doing an assessment when you're not aware of what's happening practically in the outside world. So our interactions with CVMA, livestock producers, and industry are extremely important.

[The Chair, Conservative, James Bezan]

Thank you very much.

We're going to start our five-minute rounds.

Mr. Easter.

[Wayne Easter, Liberal, Malpeque, PE]

Thank you, Mr. Chair.

Thank you, folks, for coming.

On what we call the rBGH issue, I would say that if it weren't for this committee in 1995, that would have been allowed.

I will say this upfront, that we were not very impressed with Health Canada's position on allowing it for health reasons. It was stopped for animal health reasons at the end of the day, but I know both Paul and I reviewed a lot of that documentation at the time, in 1995, and I still have concerns over the health issues of that product. I do not believe that Canada should be allowing into this country products that are produced from cows injected with rBGH. I think it's a legitimate concern.

That moves me to my point, that one of the major concerns of producers, which we've heard increasingly over the last number of years, is that products are allowed to enter this country, whether from the United States, our major competitor, or from China—and increasingly from China—products that don't meet the same veterinary standards or health standards as Canadian producers are expected to meet. It's a serious problem.

We've suggested in a previous report that if a product is coming into Canada that doesn't meet the same standards as our producers had to meet, then that product shouldn't be allowed in. I think you're going to hear that increasingly loud from this committee.

If it isn't safe, if a product from our producers goes on grocery store shelves and they're not allowed to use a certain herbicide, pesticide, feed additive, or whatever drug because it's so-called “not safe” either for worker reasons or consumer reasons, then how the heck can a product using it end up on our grocery store shelves and drive our guys out of business?

Guy made the point on residue levels. That's one thing, but there's another side of the issue. There are certain products that farmers here are not allowed to use because of the human safety factors related to the people applying the product on the land. Our producers can't use that product because of the worker concern, yet the product ends up on the shelves. So how do we deal with that issue? Are we exporting our moral responsibility for workers? Are we saying they can breathe the spray dust but Canadians can't, and then we allow that cheap product onto our shelves?

[Dr. Siddika Mithani]

You make a valid point. When we look at the review and evaluation of products, it's really important that we look at all aspects. So part of the regulatory process really focuses on the human health component as well as the animal health component. That is our mandate, when we look at Health Canada and the way we review and evaluate drugs.

I would like to be very specific, in that the review and evaluation is really based on sound science decisions. And if the information in a data submission points to the fact that there are issues with respect to human health and appropriate use of the drugs, and if there can be any risk management strategies that can be put in place to be able to manage the product appropriately, then Health Canada is obligated to make a decision on how to move that forward.

[Wayne Easter, Liberal, Malpeque, PE]

But the issue here on these sound science conditions is that some Mexican labourer's health is at risk because they're allowed to apply a product—a pesticide, a herbicide, or whatever—on a crop. Our producers are not allowed to do that in this country because of concern for the health of the people applying the product, yet that Mexican product ends up on our shelves.

Now, is there a way of dealing with that one? I understand your concerns within Canada, but for our producers on the ground, producing.... It may be the cost of human lives in Mexico in terms of their labour, or wherever else, but our producers are being driven out of business because although that product doesn't have residue in it, it's not allowed for use in Canada for reasons of the health of the workers. Yet the product still ends up on our shelves and drives our guys out of business.

Is there a way that Health Canada can deal with that issue?

In your veterinary and drug strategy plan—it relates mainly to Canada and the United States—it says that you would prepare by April 30, 1999, and that was nine years ago, a side-by-side comparison of veterinary drugs approved for use in both countries. I think that was to try to ensure that both countries have the ability to access the same drugs. Has that been done? Is it available to us, and does it include the factors I just talked about, where they have different worker restrictions from ours? It's a huge problem. It's the same thing in China—you can kill a worker, but don't allow residue to come in.

[Dr. Siddika Mithani]

In response to your—

[The Chair, Conservative, James Bezan]

Just so you know, Mr. Easter's time has expired, so I do ask that you provide a brief comment.

[Dr. Siddika Mithani]

I'm going to be very brief.

In response to your question, our mandate really looks at the health and safety of Canadians and the processes that are in place in Canada. However, in terms of products that are coming from Mexico that may have residues that are not allowed in Canada, there is certainly an effort right now between Health Canada, CFIA, and Agriculture Canada to look at some of these. So we have some targeted budget funding that is going to look at this as we move forward.

[The Chair, Conservative, James Bezan]

Thank you very much.

Ms. Skelton, the floor is yours.