Agriculture Committee on Dec. 12th, 2006

[The Chair, Conservative, Gerry Ritz]

Okay. That leads me to the next point. Part of the prohibition or the unlikelihood of the GROU working any better or giving any farmer more access to more chemicals is the cost of registration in Canada. It runs anywhere from $1.5 million to $2 million per product. That's what we're being told. Do you say no, or do you say that's reasonable?

[Dr. Karen Dodds]

It depends on what you're registering and how you're registering it, and it depends on whether you are talking about additional cost to register just in Canada, where that would be very excessive. If you already have it registered in Canada, the total new costs to the company to register in Canada are not in that order.

[The Chair, Conservative, Gerry Ritz]

Somewhere along the way they paid to register it in Canada, whether they are renewing the registration or it's the first time. The costs run in that level, and you said yourself it was a very small market here, so why would I, as a manufacturer, want to spend $2 million to come in here for 2% of my market share? That's going to be the limiting factor.

[Dr. Karen Dodds]

As I said, at this time, because in general new products are better for human health and better for the environment, with good rationale I can put PMRA resources to addressing the technology gap, so farmers in Canada have access to better product, newer product, and we're getting rid of more of the older product that is more problematic.

[The Chair, Conservative, Gerry Ritz]

Okay, but the problem is—

[Dr. Karen Dodds]

The testing to register a product—and Dr. Bennett referred to the toxicological testing—is common around the world, so we don't add to the registrants' burden with the toxicological testing. That is consistent around the world. Our costs for bringing registration to us are not $1 million. You get into that ballpark when you're talking about the costs of all the studies, not the cost just for dealing with the Canadian regulatory system.

[The Chair, Conservative, Gerry Ritz]

The studies are part of the regulatory system.

[Dr. Karen Dodds]

They are harmonized with Europe, with the U.S., with Australia, with Japan. You're not going to get your product registered in any developed country unless you've done those basic tests.

[The Chair, Conservative, Gerry Ritz]

Therein lies the rub, in that the criteria you're talking about is people's health and environment. Then it all boils down to the cost of the product to the producer as well, and that's where Canadian farmers are struggling to stay afloat, and somehow we need to address that. If it's good for people and good for the environment, I have no problem with that. That's great. Then why are producers alone paying the price in the cost of product? It's all rolled into that bottom line and the cost of the ClearOut 41 Plus or the Roundup Ready or whatever you're going to use. Why are producers alone shouldering that burden?

[Dr. Karen Dodds]

The way I express it to registrants, to any user sector, to the health groups, and to the environmental groups is that we are trying to minimize the costs the Canadian regulatory system brings to bear on registrants. We are also trying to have incentives to get products registered, so the registrants get a shorter timeline for the joint reviews. We agreed last year at NAFTA to a 25% decrease in efficacy trials, which is a savings in the hundreds of thousands of dollars, as an incentive for them to come to both Canada and the United States at the same time, so our farmers have access to the same product at the same time.

As I said, our new proposal on protecting intellectual property is that for every three minor uses they put on the label they'll get a year. The proposal is added protection as an incentive for them adding more minor uses, and for the first time in PMRA, with this project we've dedicated our own resources to addressing the technology gap. We are working to address that.

[The Chair, Conservative, Gerry Ritz]

Thank you.

Mr. Steckle for five minutes, please.

[Paul Steckle, Liberal, Huron—Bruce, ON]

My apologies for being late, but I knew this would happen this morning.

At the outset I'll say welcome. It's almost a breath of fresh air to see some progress being made at PMRA after so many years of what we felt was less than adequate performance. And that perhaps is an unfair judgment of PMRA, but I think we've moved beyond a certain point, which is the reason for our requiring you to come twice a year. So we want to thank you for coming this morning.

I missed out on some of the questions, so I hope my questions will not be repeats of what has been asked before.

Manufacturers, obviously, are looking for the greatest share of the market they can find, and obviously introducing a product into numerous countries at a particular time is important. My understanding is that PMRA has entered into new joint agreements, “review initiatives”, if you want to use that term, with the United States, Australia, and one with Austria. Obviously, there are things that we would find as common between all of these countries. If we were to look at issues that can be deemed to be common.... Let's basically look at the United States, because they're our neighbours and we commonly talk about harmonization, and if there's harmonization with the Americans, we really don't care about what happens with Australia, particularly. But if we could harmonize with the United States, we would feel we've made some progress.

What would be some common areas where you would be able to check that one off and say that one is now behind us, it is not an area where we have to do further study or further science? What are those issues that we would consider as common points where we can agree we'd go forward on? If it works in Michigan, it works in Ontario. We know the geography, the land type, and the soil type and those kinds of things. What are the really common things that we can take off the table?

[Dr. Karen Dodds]

On the human safety side, our data requirements right now with the United States are harmonized. So in terms of what is the maximum information that the U.S. EPA would look at and what is the information we would look at, that's harmonized.

On the environmental side, as I said, there remain some specific issues, and it's easier to recognize that the environmental situation differs around the world. In terms of the agricultural uses, we have moved to improve the situation with respect to sub-zones. With the United States, there is further examination of where is it. And indeed in some situations now we don't require any efficacy data on Canadian soil because there is an American zone that's close enough and you can accept American data.

For residues, there's still work to be done there.

But I do want to comment on what you said, that we want to harmonize with the United States. One of the things we're also working on now with a number of colleagues is Japan. Japan, for the first time, is establishing specific maximum residue limits. As they do that, it's having an impact on trade to Japan. We know Canadian farmers want to be able to ship product to Japan. So again, we've put some of our resources to working with the Japanese government so they understand the scientific basis of our establishing MRLs and to hopefully have them accept what we've done for MRLs.

It is the case that Japan aligns most closely with Australia, has a lot of confidence in Australia as a regulator. So in a global review, if Australia is one of the groups looking at it, you're also increasing your likelihood that Japan might accept the results. I believe Japan is actually an observer in one of the global reviews that's either under way now or scheduled for the future.

Richard has more experience with registration information and can provide a few more details.

[Richard Aucoin]

Thank you.

If I could just add, sir, with respect to joint reviews, you mentioned the joint review opportunities that we now have with Australia, with Europe, Austria. We're currently doing those joint reviews for brand new chemicals. It's interesting that the manufacturers of those brand new chemicals are able to put together one single package of data and information, not only for Canada, the United States, and Europe, but sometimes for Australia.

In those situations they're adding some additional information to cover off specific regional environment needs that Europe may have or that Canada might have or that the United States might have, and that occurs for both environment and efficacy.

From a human toxicology standpoint, that is largely harmonized to the extent where most countries are asking for essentially all the same information.

We've done a substantial amount of work over the last five or ten years in harmonizing the kind of information we have. So in terms of your question of what we can focus on, through both our work at NAFTA and through the OECD, we have narrowed down to some of those key things that can still make a difference between whether chemicals can come to one country or another or whether they might serve as an impediment to a manufacturer coming to Canada.

The number of those differences is getting very small.

[Paul Steckle, Liberal, Huron—Bruce, ON]

You would agree that we've made some substantial progress in the last two years?

[Richard Aucoin]

Yes, sir.

[Paul Steckle, Liberal, Huron—Bruce, ON]

On the issue of new product being used, for instance, in the United States, where the old product has been taken off the market and the new product is not yet available in Canada, how are we dealing with that? I know that minor use permits are given from time to time for some of these things, but are we as responsive as we need to be?

Obviously, for some it will never be responsive enough, but have we moved forward on that side of the issue? There are times we find an old product being taken away before there's a replacement for it. That leaves our farmers in a very vulnerable situation, given that the product is time sensitive.

[Dr. Karen Dodds]

Yes. There are a few things we're doing about that.

One is that our re-evaluation program now holds regular teleconferences, and anybody who's interested can participate. A number of grower groups have people participating. That is to get a better sense early of whether, if you cannot have this product anymore, it presents you with concerns. So it's to get a better understanding of where a product is being used now, where it's a critical product, so that we can see what we can do to set up.

We are specifically looking at transition strategies. We are minimizing the number of times we're taking away one tool without having another tool available. That's one thing we're doing.

At last week's NAFTA meeting we pursued further and have agreed with the United States Environmental Protection Agency to work in close collaboration, if not work share, in our future work on re-evaluation and their future work on registration review. So again, it's to recognize that what's good for new products is also good for old products. As we've said, the scientific assessment is very consistent, and one of the ways of addressing workplace pressure is to work more collaboratively with fellow regulators.

That brings with it its own pressures. Richard and a couple of other colleagues were in Bonn, Germany, to work out the scheduling details of the joint review. I need to be able to say it's worthwhile for Richard to travel to Bonn, that it isn't a tourist trip, that he's actually doing good work there.

We're also working in collaboration with the United States in developing a future timeline for re-evaluation activities.

With our Pest Management Advisory Council, we've also talked about our ability within PMRA to prioritize work. Again, the system had been to respond primarily to what registrants were bringing to us, first in, first out. Registrants are most likely driven by their bottom line, which is profit, which I don't agree should be our bottom line. I am more interested in what's happening in the Canadian environment. We're public servants. I'm interested in, as I say, giving access to newer products to all users, not just the agriculture sector.

We have talked about prioritizing and saying that if a new product is going to be a critical replacement for an old product, it will move into an earlier position in the queue and we'll address it faster.

Again, an example that I give when I'm talking with stakeholders is if it's the tenth herbicide for corn, is it as important as if it's the first for wireworm in potatoes? I think most people would agree that the latter situation, the first product to work on wireworm in potatoes, is more important for us to work on than the tenth herbicide for corn.

Again, our Pest Management Advisory Council saw merit in that and supported us going forward with it.

[The Chair, Conservative, Gerry Ritz]

Thank you, Mr. Steckle.

Mr. Miller.

[Larry Miller, Conservative, Bruce—Grey—Owen Sound, ON]

Thank you, Mr. Chairman. I may be splitting my time with the member from Wainwright.

I want to go back to what Mr. Bezan, Mr. Ritz, and some others have talked about in regard to the products and the timelines, like the frost in the fall that you talked about. My biggest problem with this, Dr. Dodds, is that it almost gives the appearance or implies that farmers aren't as smart as they should be and don't know how to use the product. It almost even implies that they're untrustworthy. Being a farmer and knowing a lot of farmers, I can tell you that both are far from the truth.

I know—at least I'm quite sure—that nobody at PMRA meant to imply that, so what are the reasons to justify that? Regardless of whether the product has a timeline as far as frost is concerned, no farmer has been known to deliberately put something in that's going to be bad for the environment. And cost always comes into it as well. A farmer is usually pretty conservative in the pocketbook because his margins are so fine. He's not going to buy something and use it if it's basically not going to give him some kind of financial benefit. Perhaps you could comment on that.

And I have another question. Last Friday, this government announced a new chemicals management plan. I think PMRA will be affected by that, so I'd just like to know how some of those changes are going to affect you. Maybe you could comment on that.

[Dr. Karen Dodds]

First, let me go back to this fall's experience with the own use import program and permits. Let me reassure you that as regulators we don't want to be seen to be arbitrary. We actually looked at whether we are being too strict and too tight with respect to applying the rules. My first question to the specialist was, “What is the impact of the killing frost on the effectiveness of the product?” I am a scientist, but I'm not a plant person at all. We had people sending us pictures of green plants, green weeds in their fields, saying the product will work. Well, it doesn't.

The information we have is that glyphosate is a systemic product. It has to go into the root system and be taken up by the plant. Even before a killing frost, the plant has stopped that kind of metabolism. You may see an effect, but it's likely an effect due to temperature and frost rather than an effect due to the herbicide itself. That's the information I got.

We checked with the provincial people, because we had folks saying there hadn't been a killing frost, and we checked with our regional people. They all said, “No, this has happened.”

[Larry Miller, Conservative, Bruce—Grey—Owen Sound, ON]

Perhaps I'll interrupt you there and go back to a comment that Gerry made. I'm not trying to be smart or anything like that, but Gerry made a comment that sometimes it takes a killing frost to make this work. I haven't used that product myself, so I'm asking simply because I don't know. What is your comment to his, that sometimes you need that frost to make it work a little bit better?

[Dr. Karen Dodds]

Again, I don't know whether Richard has more details, but we did check with our people on whether this specific product would work after a killing frost and they said no.

Not all glyphosates are the same. They have different formulas, different adjuvants, and different safeners. The information we got was that this product does not work, which is why it's on the label like that. To use a product inconsistently with the label is not in compliance with the Pest Control Products Act and regulations.

The other thing I want to say is that at the NAFTA meeting last week, as an example, we did not have environmental groups represented. We did not have health NGOs represented. The discussion at the Pest Management Advisory Council is that right now those groups are fairly satisfied with where we are as a pesticide regulator and where we want to go. They aren't concerned about the own use import program.

Our provincial colleagues raised the container disposal problem with us. In terms of us taking it forward, we are trying to make sure we are keeping environmental groups and health groups as satisfied as critical user groups, which obviously include agriculture, when it comes to what we're doing as a pesticide regulator. That's not an easy job of balancing.

Right now we're at a point where, quite literally, we've had some of the environmental groups say, “We are satisfied and we may actually not continue on your Pest Management Advisory Council because we have other fish to fry, other issues that are now of a higher priority.” With the own use import program, they've been very carefully watching what is happening and how Health Canada is enforcing, because they recognize that this is product that isn't registered in Canada but is brought in under other things.

In dealing with the own use import, we're also thinking of what the provinces are raising to us as concerns and what the health and the environmental groups are raising to us as concerns. They were invited to be part of the own use import task force, and both the health and the environmental groups elected to see all the documents and raise issues just in a paper review. Again, they've maintained enough satisfaction and confidence that they haven't been active participants. They've just been watching all of the written information, which we've been continuing to share with them, as with everybody, in regard to what's going on with that program.

[Larry Miller, Conservative, Bruce—Grey—Owen Sound, ON]

Maybe you could answer my other question a little later. I believe Leon has to leave, so I'd like him to get—

[Leon Benoit, Conservative, Vegreville—Wainwright, AB]

No, I don't. I'll get a round in later.