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37th PARLIAMENT, 1st SESSION

Standing Committee on Agriculture and Agri-Food

COMMITTEE EVIDENCE

CONTENTS

Thursday, February 7, 2002

0910

The Chair (Mr. Charles Hubbard (Miramichi, Lib.))

Dr. Claire Franklin (Executive Director, Pest Management Regulatory Agency, Department of Health)

0915

0920

Mr. Daniel Chaput (Director, Compliance, Lab Services and Regional Operations Division, Pest Management Regulatory Agency, Department of Health)

0925

Dr. Claire Franklin

Ms. Janet Taylor (Manager, Registered Product Evaluation Business Line, Pest Management Regulatory Agency, Department of Health)

Dr. Claire Franklin

0930

The Chair

Mr. Hilstrom

The Chair

Mr. Bob Speller (Haldimand--Norfolk--Brant, Lib.)

The Chair

Mr. Hilstrom

The Chair

Mr. David Anderson (Cypress Hills--Grasslands, Canadian Alliance)

0935

Dr. Claire Franklin

Mr. David Anderson

Dr. Claire Franklin

Mr. David Anderson

Dr. Claire Franklin

Mr. Daniel Chaput

Mr. David Anderson

Mr. Daniel Chaput

0940

Mr. David Anderson

Dr. Claire Franklin

Mr. David L. Anderson

Dr. Claire Franklin

Mr. Anderson

The Chair

Mr. Marcel Gagnon (Champlain, BQ)

The Chair

Mrs. Rose-Marie Ur (Lambton--Kent--Middlesex, Lib.)

Dr. Claire Franklin

0945

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

The Chair

0950

Dr. Claire Franklin

The Chair

Dr. Claire Franklin

The Chair

Mr. David Anderson

The Chair

Dr. Claire Franklin

Mr. Daniel Chaput

The Chair

Mr. Marcel Gagnon

The Chair

Dr. Claire Franklin

0955

Mr. Gagnon

Mr. Marcel Gagnon

The Chair

Mr. Bob Speller

Dr. Claire Franklin

Mr. Bob Speller

Dr. Claire Franklin

1000

Mr. Bob Speller

Dr. Claire Franklin

Mr. Bob Speller

Dr. Claire Franklin

Mr. Speller

Mr. David Anderson

Mr. Bob Speller

Dr. Claire Franklin

Mr. Bob Speller

Dr. Claire Franklin

Mr. Bob Speller

The Chair

Dr. Claire Franklin

Mr. Bob Speller

Dr. Claire Franklin

Mr. Bob Speller

The Chair

Mr. Dick Proctor (Palliser, NDP)

1005

Dr. Claire Franklin

Mr. Dick Proctor

Dr. Claire Franklin

Mr. Dick Proctor

Dr. Claire Franklin

Mr. Dick Proctor

Dr. Claire Franklin

Mr. Dick Proctor

Dr. Claire Franklin

The Chair

Mr. Paul Steckle (Huron--Bruce, Lib.)

1010

Dr. Claire Franklin

Mr. Richard Aucoin (Acting Director, Product Sustainability and Coordination Division, Pest Management Regulatory Agency, Department of Health)

Mr. Paul Steckle

Mr. Richard Aucoin

Mr. Paul Steckle

Mr. Richard Aucoin

Mr. Paul Steckle

Mr. Richard Aucoin

Mr. Paul Steckle

Mr. Richard Aucoin

Mr. Paul Steckle

Dr. Claire Franklin

1015

The Chair

Mr. Rick Borotsik (Brandon--Souris, PC/DR)

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

1020

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

The Chair

Dr. Claire Franklin

Mr. Rick Borotsik

Dr. Claire Franklin

The Chair

Dr. Claire Franklin

1025

The Chair

Mr. Mark Eyking (Sydney--Victoria, Lib.)

Dr. Claire Franklin

Mr. Mark Eyking

Dr. Claire Franklin

Mr. Mark Eyking

Dr. Claire Franklin

1030

Mr. Mark Eyking

Dr. Claire Franklin

The Chair

Mr. Hilstrom

Dr. Claire Franklin

Mr. Hilstrom

The Chair

Mr. Hilstrom

Dr. Claire Franklin

Mr. Hilstrom

Dr. Claire Franklin

Mr. Richard Aucoin

Mr. Hilstrom

Mr. Richard Aucoin

Mr. Hilstrom

Mr. Richard Aucoin

Mr. Hilstrom

1035

Mr. Richard Aucoin

Mr. Hilstrom

The Chair

Mr. Hilstrom

The Chair

Mr. Calder

Dr. Claire Franklin

Mr. Calder

Dr. Claire Franklin

Mr. Calder

Dr. Claire Franklin

Mr. Calder

The Chair

Mr. Marcel Gagnon

1040

Dr. Claire Franklin

The Chair

Mr. Dick Proctor

Dr. Claire Franklin

Mr. Daniel Chaput

1045

Mr. Dick Proctor

Mr. Daniel Chaput

The Chair

Dr. Claire Franklin

The Chair

Dr. Claire Franklin

The Chair

Mr. Rick Borotsik

Ms. Janet Taylor

1050

The Chair

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

Mrs. Rose-Marie Ur

Dr. Claire Franklin

1055

Mrs. Rose-Marie Ur

The Chair

Dr. Claire Franklin

Mrs. Rose-Marie Ur

The Chair

Mr. David Anderson

The Chair

Mr. Dick Proctor

The Chair

Mr. Proctor

The Chair

Mr. David Anderson

Dr. Claire Franklin

1100

The Chair

CANADA

Standing Committee on Agriculture and Agri-Food

NUMBER 043

1st SESSION

37th PARLIAMENT

COMMITTEE EVIDENCE

Thursday, February 7, 2002

[Recorded by Electronic Apparatus]

¿ (0910)

[English]

The Chair (Mr. Charles Hubbard (Miramichi, Lib.)): Good morning, everyone.

We'd like to call the meeting to order: pursuant to Standing Order 108(2), a study on the registration of pesticides and the competitiveness of Canadian farmers.

At our meeting this morning we have, from the Department of Health, Dr. Claire Franklin, the executive director of the Pest Management Regulatory Agency, and several of her staff. Dr. Franklin has indicated that her presentation may be a bit long, maybe close to 20 minutes. They've divided it into sections dealing with each aspect of the pesticide review situation.

With that, Dr. Franklin, we'll open the floor to you and to your staff. Welcome. We're waiting in anticipation.

Dr. Claire Franklin (Executive Director, Pest Management Regulatory Agency, Department of Health): Thank you Mr. Chairman.

When I was invited to make this presentation, I was asked to do it focusing on the mandate of PMRA and on the registration. For the members, I would point out that we have a number of activities in addition to just the registration aspects, but that's what I was asked to focus on today.

Janet Taylor, Daniel Chaput, and Richard Aucoin will be focusing on specific areas. I thought we would get better coverage for issues I know are of interest to you.

With regard to the mandate, as you know, the consolidation of pesticide regulation under the Minister of Health occurred in April 1995. The Pest Control Products Act is the act under which the statutory responsibility flows for pesticides. Its aim is to prevent pest control products from entering or remaining on the market if they are of unacceptable risk, merit, and value.

That did not change when the act was moved from the Minister of Agriculture to the Minister of Health. Following recommendations of the multi-stakeholder pesticide registration review--and I anticipate that several of you may have actually been involved in that; that was a 1990 review--the mandate was recommended by that group and agreed to by the government in 1994. As stated, the mandate was to recognize the principles of environmental sustainability.

The mandate of the agency would be to protect human health, safety, and the environment by minimizing the risks associated with pesticides while enabling access to pest control products and pest management tools. In the report it was also stated that the pursuit of an efficient system to register pesticides does not override health and environmental protection.

PMRA has a rigorous pesticide approval system. It is recognized worldwide for the soundness of its methods. This has been a major factor in our capability to work collaboratively with EPA and other regulatory agencies, which is an important aspect for harmonization, one I will comment on.

With regard to the registration of new products, the manufacturer of the pest control product--and I will refer to that person as a “registrant”--cannot legally sell the product in Canada unless it's registered. The registrant determines if, when, and for what uses the application will be made. It is not the agency that determines that. That is fully the responsibility of the registrant.

To obtain a registration, the registrant must submit an application with data. We review the data and make a decision based on the acceptability of the safety, merit, and value of the product. The application for a new active ingredient contains data on chemistry, health effects, environmental effects, and efficacy. These are very large data packages that are submitted to governments. The application is screened to see that all the required data is included and that studies are complete. If they are, the submission is accepted for review. We have performance standards for review of all types of submissions that have a complete and reviewable data package.

The one aspect I would like to mention is that there are new approaches to risk assessment. These were driven in 1996 by the U.S., who announced a major new initiative to protect children from potential risks of pesticide residues. Risk assessment was changed at that time to take into account special sensitivities of children. They had always been included, but there was an even greater focus on the protection of children, an additional safety factor of at least 10 times, though it could be lower if the data supported that.

We also look at aggregate exposure, which means whether there are residues in food, water, or the area in which children are playing or people are exposed. Cumulative risks... if there are products that exert their toxicity by the same method, that has to be added up and taken into consideration during the risk assessment. With these new approaches, the total amount of exposure a person could safely have in one day has gotten considerably less. If we use the analogy that all the exposure that can safely be used is equivalent to a risk cup, these risk cups have gotten smaller. The other aspect that's really important to bear in mind is, the more uses a pesticide has, the faster the risk cup will fill up.

To do these modern risk assessments we need to have residue data for all food uses, including minor crops, since they can be big contributors to the diet, particularly for children. These residues and this amount must be taken into consideration in the risk assessment. Daniel will be talking in more detail about minor use and the impact that these changes have made.

I also would like to emphasize that we do use relevant data from other countries, particularly the U.S., where the zones are the same so the climactic, geographical soil conditions are similar.

I'd like to comment on reduced-risk products. There seems to be a misperception that PMRA doesn't recognize the need to register reduced-risk products. This is not the case. We recognize not only their importance to health and the environment but also the need for Canadian growers to have access to them at the same time as U.S. growers. It was for these very reasons that the joint review process that we initiated in 1996 focused initially on reduced-risk products.

In 2000-01, which is the last full year that we have data, fully 62% of the technical active ingredients that we registered in that year were for reduced-risk products. A comparison with the U.S. shows that 73% of their technicals in the same year were reduced-risk products. So we're not that far off. However, we do want to further encourage registrants to submit reduced-risk products, particularly biologicals that they've already submitted to the U.S. To encourage that, we're planning to introduce a national program for reduced-risk products using the same classification criteria as EPA.

I have a few statistics to put a perspective on the magnitude of our task. There are 550 active ingredients registered in Canada, 6,124 products, and 931 registrants.

All of the statistics that I'm quoting and talking about will be for the year 2000-01. In that year we received 3,565 submissions. We made 3,325 decisions; 86% of the decisions were positive. Approximately 25% of our submissions and decisions were on agricultural products and 75% were on non-agricultural products.

Is the process more efficient with PMRA than before? Yes, it is. We're registering twice as many new active ingredients a year now than were registered before the formation of the agency. As I mentioned, we've seen a remarkable increase in the number of reduced-risk products from about 11% prior to the agency being formed to 62% in 2000-01.

Time for registration is always an interesting factor. We hear people stating on many occasions that it takes years and years. I don't deny there are products that will take a long time. We've had some products put in before the agency was formed that were quite incomplete. We've worked with the registrant to try to get the information. We've held those ones while the information is being generated. So there will be some that have long timeframes.

For the technical active ingredients that we registered in 2000, we had five submissions that had no deficiencies. The time from submission to registration was 11 months. I would like to congratulate the registrants who put in submissions that were complete, had no deficiencies, and were able to be reviewed according to the standards we've established.

If we look at all of the actives that came in that year, the total time from when they were in the door to when they were registered was 21 months. In comparison, the shortest time for the U.S. EPA registration for reduced-risk products is 22 months and for non-reduced products is 31 months.

So I'd like to point out that we're doing a job that's at least comparable, if not faster, than the U.S. for the products. I'd also point out that they have a budget for new submissions that's five times larger than our budget.

The other aspect that I know I have raised at various points is the completeness of the submissions. We're seeing steady progress in that, which is really industry working with us to get their submissions in good shape so we can review them in the timeframes we've indicated. Last year, fully 70% passed screening for the first time. Again, that's a remarkable increase and will help us do our job and help products get to market faster. We continue to work with industry, so more of the submissions will pass the deficiency review the first time. Improvement is being made on all sides, I might add.

¿ (0915)

The other question is: what is the cost of registration to manufacturers and farmers? There is no cost to farmers. The fees are paid by the registrants, and the application costs vary from $228,000 for a new technical active ingredient with food uses, to essentially zero for minor-use label expansion bio-pesticides, which include microbials and pheromones.

We were mindful when the fee structure went in that we did not want to discourage minor-use label expansions, and that's why were very careful with the fees for that. It's the same with the biological products.

On the impact of cost recovery, despite concerns before it was implemented, we've had approximately the same number, about 6,100 products, registered before cost recovery and after. So there's no indication that's had the negative impact everyone was concerned about prior to its implementation.

I know the impact of cost and availability of products on competitiveness is an issue you are definitely exploring. We rely on Agriculture Canada to provide the measures for those, but it would certainly seem reasonable to conclude that if there's not a product for a particular pest, that will have an impact. I'd like to point out, though, that lack of a new product doesn't necessarily mean there isn't a product to deal with a pest.

The other question was: does regional availability have an impact? Yes, it does, but we are very cautious when we have to register that it's available in one area and not another. It's not something we like to do, but the growing conditions, climate, and soil types can have an impact on how a product works and the tolerance of a crop to a pesticide, so those factors have to be taken into consideration. Those decisions are not taken lightly, I might add.

I'll now ask Daniel to speak about the minor use program.

¿ (0920)

[Translation]

Mr. Daniel Chaput (Director, Compliance, Lab Services and Regional Operations Division, Pest Management Regulatory Agency, Department of Health): Thank you, Dr. Franklin.

I would now like to say a few words about the Minor Use Program. Minor use products are those products for which the projected sales volume is not high enough to convince a manufacturer to produce data necessary for registration.

As a regulatory agency, we recognize that these products are of major significance in agriculture. That is why PMRA facilitates access through specific programs involving an expedited review process. For these products, we're looking at a registration time frame of six or twelve months in view of the absence of fees, as Dr. Franklin mentioned, or of significantly reduced fees.

[English]

Having said that, we've put these programs in place to facilitate access, but there is still a need for us, as in any registration, to review data to ensure the safety, merit and value of these new uses. We often hear the comparison between the Canadian and U.S. situations in terms of the number of uses available to growers on both sides of the border. This is a fact that is fully recognized, but when we do this comparison we have to go broader in looking at the regulatory agencies. It is what happens from the time a need is identified for a pesticide to the time a submission is put into the system.

Let's make that comparison, just to see the broader picture. In the U.S., since 1963, they've had a program in place called IR-4, which is almost fully funded by the USDA. It generates the data needed to support many-use registration, putting quality submissions in place and submitting to the EPA. That makes things much easier. This is, I guess, one of the key reasons for this discrepancy in number of uses.

In comparison, in Canada, growers have access to about $400,000 in funding to generate minor-use data, but there is no organization to coordinate all of this work and put a quality submission or a complete submission in place. That creates problems and explains, to a very significant extent, the differences in the uses available to Canadian growers.

We at the PMRA have looked at the IR-4 system quite extensively. We've also looked at systems in other countries, and we're working very closely with AAFC to see what we can learn from these systems and how they can be adapted to the Canadian situation. There's always room for improvement in the regulatory system, but until these parts come closer together, there will always be these discrepancies.

I'll leave it at that for now. Thank you.

¿ (0925)

Dr. Claire Franklin: Thanks.

I've asked Janet Taylor, who's the manager responsible for the re-evaluation program, to say a few words about that. Janet.

Ms. Janet Taylor (Manager, Registered Product Evaluation Business Line, Pest Management Regulatory Agency, Department of Health): We published in March 2001 a document that outlined a new approach to re-evaluation. It's a much more ambitious program than we've ever had, one aimed at expediting the re-evaluation of many of the active ingredients. The reason this expedited program is possible is because we committed to use international reviews of data, and we are especially relying on U.S. reviews of toxicology and exposure and on U.S. environmental data.

The target of the program is to review all the pesticides registered prior to 1995 in light of the newer data requirements and the newer standards Dr. Franklin mentioned, and we would like to complete this by 2006. The target for this program is the same as the target of EPA.

We have several major blocks of re-evaluation underway, and I'll just mention them briefly. We are looking at the organophosphate insecticides; there 27 active ingredients. We have also taken on the major lawn pesticides in view of the increased focus on child safety, and that includes four herbicides and four insecticides. That one is virtually coming to completion; we're just wrapping up some of the active ingredients there.

We just completed a major review of the insect repellents, which has been a focus because of West Nile virus and various issues such as that. We have a couple of special reviews, one of Lindane, and we've been looking at anti-fouling paints, which are used on large ocean-going vessels. We have also had an ongoing review of the heavy-duty wood preservatives, so we have some pretty substantial blocks underway right there.

Coming back to the organophosphates, I'll focus on those for a few minutes because those have largely agricultural uses. As to the 27 that I mentioned, currently about four or five of those have been withdrawn. We're focusing on the rest of them. Initially, what we looked at were the residential uses, because many of these products have been used for many years on lawns, around homes, and so on, so we have been looking at that initially. The basic reviews are almost completed. As far as the agricultural uses are concerned, although the products are labelled for a substantial number of uses, we wanted to get good information on how they're actually used. We worked with the provinces and with the provincial governments did surveys of the user organizations in all the provinces, and we had very good cooperation on that.

What we're trying to do is recognize the important uses, and one of the risk mitigation measures is obviously to reduce use. Through this process we're trying to find out which of the uses are critical and important, to focus on those, and to find other means for the other less important uses. We have not yet published a single consultation document, and that was part of process, to bring all the science reviews together with the situation as we saw it on what was needed and what we could do to propose regulatory actions.

One of the problems we're having is getting registrants to sign off on our consultation documents under access to information legislation. There is a requirement not to publish confidential business information. As a precautionary measure, we ask registrants to sign off on such documents before we publish them. We have not yet had good success in that endeavour. However, we're working at it, and hopefully we'll start getting these documents out soon. They will be going out with the results of the review and with the proposals for regulatory actions, risk mitigation, and reduction of uses, and they will ask if we have seen that picture accurately. Then, after that kind of consultation, we'll be coming to some regulatory conclusion on these products.

I think that's basically all I have to say.

Dr. Claire Franklin: I'll close our comments on the issue of harmonization. It's an activity we've been very involved in since the formation of the agency, and it's certainly clear there are significant benefits to harmonization. I recognize that the term means different things to different people. We did try to make certain that the position the U.S., Mexico, and we were taking under the NAFTA harmonization was articulated in a document published in 1998.

It fosters coordinated decisions. Certainly that's a very significant aspect. From our perspective, and one I know you are interested in, it really makes products available to growers at the same time on both sides of the border, so it's a very important approach.

I realize everyone is impatient. It does take time to get these in place. We believe we've had very good success with this. We have over half of the new active ingredients coming to Canada now, either through joint review or work share. I think that's a very significant success and we're hoping to see that increase year by year.

The document, as I mentioned, describes the roles of registrants, the roles of growers and our role, and everyone has a part to play in that. It's been very interesting.

The head of the U.S. Environmental Protection Agency Office of Pesticide Programs and I have met with the various companies, with the U.S. counterpart and the Canadian counterpart, to try to find ways that product development can start in a joint way with the thought of coming into the North American market at the same time. So I think there's been improvement and a change in the thinking at the manufacturer level, as well, for that.

As I mentioned earlier, the first joint review program was for reduced-risk products. That was in 1996. For biologicals it was in 1997.

There are compressed timeframes. Our performance standard for review of submissions is 18 months for the joint review ones. We committed to 12 months for the reduced-risk ones. It's been expanded to cover all types of new active ingredients now, with negotiable timeframes. We in fact have had a pilot project on minor-use joint reviews and that was successful, so we're now in the process of formalizing a joint review for minor use, which I think will be very helpful.

There is a NAFTA milestone report available. It was released at the NAFTA meeting before Christmas, and we can certainly make that available to the committee. It has a very good summary of all of the activities we've been involved in.

With that, Mr. Chairman, we will conclude our remarks and try to answer whatever questions you might have. Thank you.

¿ (0930)

The Chair: Thank you, Dr. Franklin.

Only this morning our office received a letter from the chair of the Standing Committee on Environment and Sustainable Development. Mr. Caccia referred our committee to the report of the environment committee, entitled Pesticides: Making the Right Choice For the Protection of Health and the Environment. I will circulate it. Some of your staff may want to review that. There is a chapter specifically, Dr. Franklin, as you know, dealing with the aspect of children.

Howard.

Mr. Howard Hilstrom (Selkirk--Interlake, Canadian Alliance): Mr. Chairman, David is going to lead off for our party on questioning, but we've had this submission here this morning and a large number of statistics referred to and reports referred to, and this is a government department under Health? Surely they had the capability to provide us with a little printout of these statistics and references. As committee members, we can't remember everything they said and try to make notes and get this right.

Could you instruct the presenters to provide that? I have a complaint that they should have provided that to this meeting right now.

The Chair: I think Dr. Franklin has made a note of that.

Mr. Bob Speller (Haldimand--Norfolk--Brant, Lib.): Also, you can get it on the net. It would be quicker off the website.

The Chair: We're really crossing three or four departments again with this. They are from the Department of Health and, of course, we had the environment group who looked at it, and probably Industry Canada.

Mr. Howard Hilstrom: I agree on that, but they can only really speak for themselves, and that's what they should be doing here.

The Chair: Yes.

David, are you going to lead off?

We'll go then to Marcel and Rose-Marie.

Mr. David Anderson (Cypress Hills--Grasslands, Canadian Alliance): I guess what strikes me this morning is that you've shown you're better salesmen than administrators. You paint a picture this morning that's one of efficiency in your department, of working well with the Americans and of being able to do a good job of registering these chemicals.

Virtually everyone else who has come in here has given us a different picture. They've talked about the frustration of trying to deal with your department, of inefficiencies, of obstruction of registrations--of people pulling registrations out because there was no point in pursuing them.

I want to give you a chance this morning to tell us what changes you feel need to be made in your department or to the Pest Control Products Act so that we can improve some of these things and accelerate the registration process without damaging health and environmental issues.

¿ (0935)

Dr. Claire Franklin: The comments and statistics I presented are the ones we have.

As I also indicated, as an agency we inherited approximately 1,000 submissions that were in a backlog. It has taken us a considerable amount of time to try to work with those particular products and to find the appropriate decision that can be taken on them. With 3,000 decisions being made in a year, you will be able to find ones that will not have worked as smoothly as the registrant or we ourselves might have wanted. I already stated that.

But I think we do have to consider that the steps we have put in place, and we have been under a requirement to do this more efficiently and also to increase the capacity... There's no question that the new submissions that are coming in are larger and more complex, and it takes a greater effort to try to work with them.

You asked what changes could be made in legislation that would assist. I believe the capacity to be more open will help everyone, because I think that in many instances we are hampered from being able to make statements on whether a submission is in and whether we've refused it. Those are the limitations with which we're faced. In many instances it doesn't allow us to necessarily contradict or counter some of the statements that are out there. So we certainly feel that openness will be healthy for everyone. It will give people an opportunity to see exactly what we're doing and to be critical as appropriate. It will certainly benefit the confidence of the public. In the environment committee a number of concerns were raised. A lot of that is based on the fact that information isn't readily available. The basis on which we make our decisions is not publicly available. So from our perspective, I think that will definitely help, and it will make the system a whole lot healthier.

Mr. David Anderson: Witnesses tell us that the system has gone from a reasonably efficient one to one of the worst they have had to deal with in the last number of years. Can you tell me why they would say that?

Dr. Claire Franklin: If there are specific examples, I would be more than happy to try to address them.

Mr. David Anderson: I can give you a specific example. These aren't the people who said that. Farmers of North America have been trying to get an own-use application, and from the information they present, they felt that they've dealt very straightforwardly and honestly with the application process. As they've gone through it, it has been continually changed in order to put what they would see as barriers in their way to approval of this product. That would be one example I could use of an organization that is very frustrated.

Dr. Claire Franklin: I'd like to respond to that, and I would ask Daniel to comment. This one is a very interesting situation, and I think we've spent a considerable amount of time with the members of the organization. I was going to call them registrants. They're not.

Daniel.

Mr. Daniel Chaput: We've had a number of communications with FNA since last April or May informing them of the requirements for a successful own-use import application.

I think we have to keep in mind that before a product is imported into Canada, either it needs to be registered or under certain circumstances there are possible exemptions. Own-use import is an example where an exemption of registration is possible. But there are conditions to this exemption to ensure that the purpose of the PCP Act, health and safety, is not—

Mr. David Anderson: The problem has not been the conditions. The problem has been that the conditions have changed continually as they've gone through.

Mr. Daniel Chaput: No, the conditions have been the same from the start. FNA did not meet the requirements. It is very clear. The condition is that they have to establish chemical equivalency between the product they want to import from a foreign source and current Canadian registered products, and they have not submitted information to establish chemical equivalency. The standards we're using to establish chemical equivalency are internationally recognized standards to characterize the composition of a product. There's nothing specific to PMRA.

¿ (0940)

Mr. David Anderson: When you talk about openness, you need to begin in your own backyard. If you're giving people different information as they go along, they don't understand what it is they need to do.

The other issue I want to follow up on is that in 2000-01 there were a total of 22 minor-use registrations approved by you. In the same period, 1,200 of them were approved in the United States. Since 1997 you apparently had only seven new active ingredients for traditional pesticides registered under the joint registration initiative. What kinds of incentives do you envision to get more applications and to speed up those processes, and do you have some specific plan to enhance that activity?

Dr. Claire Franklin: Well, I'll ask Daniel to speak to the minor-use one, but I will speak to the joint review. As to the steps that are in place on that one, as I mentioned, we have reduced the time. We feel that it's significant, and as we're told by registrants, time is very important to them. If we have shorter timelines for products, that's definitely an incentive.

As I mentioned, we're seeing that part of the reason it takes time for joint reviews to come up to speed is that registrants do have to develop their data so they really are considering the package, that it is available to both countries at the same time. I believe this is working. The other aspect, as I mentioned, to encourage submissions, particularly the reduced-risk ones, is that we will reduce timelines to encourage registrants to put in the reduced-risk products.

Mr. David L. Anderson: How can you say it's working if [Inaudible—Editor] seven of them since 1997, that's all, and companies have been so frustrated that they've pulled out of the process?

Dr. Claire Franklin: For the companies we've dealt with on an individual basis, that's not necessarily the comment we're hearing. I think that in fact it's a very useful process, one that does get them to market in Canada and the U.S. at the same time.

Any new process like that takes time to build, and we've had companies that started with us on this and helped us refine this. We're dealing with two large regulatory agencies at the same time, so it does take a certain amount of hand holding to work our way through those.

Mr. David Anderson: How much political interference?

The Chair: Thank you, David.

Marcel.

[Translation]

Mr. Marcel Gagnon (Champlain, BQ): I'll wait until after the members opposite have spoken, if you don't mind.

[English]

The Chair: Rose-Marie is the one who's been very active on this file.

Mrs. Rose-Marie Ur (Lambton--Kent--Middlesex, Lib.): The reason I'm really pleased that we brought it before committee is that we hear a lot about it.

As you indicated in your statement this morning, Ms. Franklin, the birth of PMRA... well, this is the longest birth I've ever witnessed. It hasn't changed from when you presented way before, and as politicians, as part of the government, it's so frustrating for us to try to explain this to the people who come day after day to our offices or call asking what our problem is.

As Ms. Taylor said, we're still working on the backlog. I heard that when I first heard a presentation from PMRA, and we're still working on the backlog.

Is there a checks and balances system within the PMRA? Do you have to report to the health department? Who is your overseer, so we're making sure that things are happening reasonably?

Dr. Claire Franklin: I report to the Deputy Minister of Health; the agency is within the department.

I would just like to clarify “backlog”. The backlog I spoke about when we met on earlier occasions was for new products. We have no backlog. We cleared that off within two years of the agency being started, so I think there was progress on that in a remarkably short period of time. We don't have a backlog for new products in Canada. The U.S. does, and in fact they limit the number of applications that come in to control or manage their backlog. I think that's a really important piece of information for us to know.

The backlog Janet refers to is the backlog of old products for which we have only recently got resources to be able to have an aggressive re-evaluation program. We are trying to work very closely with the U.S. on that so health and environment are not impacted by having older products left on the market when they shouldn't be. It's very clearly two different aspects, and I think there's good progress in new products.

¿ (0945)

Mrs. Rose-Marie Ur: I can appreciate that.

Are these old products a detriment for our Canadian farmers regarding export markets? Are they a problem?

Dr. Claire Franklin: The products become a problem to growers if they're...and it really doesn't focus just on old products. If they're registered in one country and not in the other, there can be an impact on the capacity for growers to export their products. We have a situation, even with newer products, that if they're registered...and as you well know, for the non-minor use areas, many of the products for grains and oilseeds are actually registered in Canada first. If there's not an MRL or a tolerance established in the U.S., there can be challenges with that. It works both ways, and yes, if it isn't registered in one country and there's a residue on it, then that can cause a problem.

Mrs. Rose-Marie Ur: Are the standards and criteria for registration in the United States much the same standards as here in Canada? Is there a big discrepancy in making an application in the United States versus Canada?

Dr. Claire Franklin: The activities that we've had under the NAFTA technical working group have really worked to get the data requirements harmonized as well as the protocols under which the studies are done. In fact, they're not 100%, but they're sufficiently close; they're 90%-plus in many of the areas that a submission can be made at the same time. That really was the key for us to be able to have joint submissions. It's been very critical that happened.

Mrs. Rose-Marie Ur: But that being said, as Mr. Anderson said, we've only had seven joint registrations since 1997. That doesn't really seem like a significant number to me.

Dr. Claire Franklin: It may not, but there's a certain amount of lead time that registrants have to come to grips with. They may have started development of a product for use on crops in the U.S. and they don't have the information for use on crops in Canada, so that precludes them from being able to come in at the same time. That's really been part of the challenge for ourselves as well as for registrants.

Mrs. Rose-Marie Ur: How would you feel if there was an ombudsperson appointed to work within the PMRA? Constantly when I get a call from some of our farmers wanting to know why they can't get this certain product, I call the department or the agency, and the story is that the application was not submitted in the correct fashion. I find that hard to believe, because these people aren't doing their first application. As a rule, they've gone through the loopholes and really know what to do. If you say that the applications aren't complete and then that takes up time and all the rest, would it not be feasible then to have a person who, when those applications come in--and obviously they can't be that different--will go down A, B, C, D and make sure they're all there so that it's done and moved on? So if there's something missing, you track it right away rather than having it on the in-and-out pile on someone's desk for three to four months.

Dr. Claire Franklin: The suggestion you make is one I think we should certainly take under consideration. I believe in the U.S. they do have a person who is really a focal point like that.

But I wouldn't like to leave you with the thought that because a registrant has put submissions in, they're always perfect. We do find that there are challenges. But we do have people who are working or trying to work with registrants for that, so it isn't a matter that they just come in and they're not dealt with.

There's no question, as I said a little earlier, that from a screening perspective we're seeing improvement. It's certainly in our interest that we ensure that registrants know the information they need to have in a submission and we do put on training programs. I think those are areas for which we can certainly try to have more of these so that there are no surprises when a submission comes in. That's not our intention. Our intention is to have a good quality submission come in, work with the registrant so they know what that entails, and then it can go through the system quickly.

The Chair: Thank you, Rose-Marie.

Before I move on here, you indicated that you have no backlog, which means you have no files, old files for new applications, that are older than...I think you said 20 or 21 months. Is that what you meant by “backlog”, Dr. Franklin?

¿ (0950)

Dr. Claire Franklin: The term that we use for “backlog” means that when submissions come in they should be picked up and dealt with. It doesn't mean that they're going to be less than that particular time because they cycle. They come in, and if they're not complete the registrant has an opportunity to put in the information that may be missing. There are various steps, and each of those has a performance time on it so that when they come in they're then dealt with.

The Chair: But to define “backlog”, do you have files for new products that are older than....

Dr. Claire Franklin: There may be.

The Chair: There may be. So there is a backlog, then, really.

Mr. Anderson asked a question. He indicated that there were just a few products approved by your agency, whereas in the United States there were, what, 1,200 did you say, David?

Mr. David Anderson: No.

The Chair: We have no applications? Or where is this great divergence?

Dr. Claire Franklin: The difference? I'd like Daniel to comment.

There is no question that the number of applications we have under the minor-use program is considerably lower than the ones that come into the U.S. I think that's really a point worth considering and discussing.

Mr. Daniel Chaput: Mr. Chairman, I think you kind of provided the response when you said there's no application. I think it goes back to the presence in the United States of the IR-4 program, which is fully funded by USDA at $25 million Canadian a year, to support the generation of minor-use data and put submissions together and submit them to the EPA. This is outside of the regulatory agency, and that does explain this discrepancy in terms of the number of minor-use label expansions in both countries. In comparison, as I mentioned before, here in Canada last year there was about $400,000 provided to growers to generate the data and no organization to coordinate all of this and submit complete submissions.

Our performance is very dependent on the quantity of the input we have. Our raw material is the submission. If the submission is not there, or is totally incomplete, there's not much we can do. There's nothing in Canada that is comparable to the U.S. IR-4 to provide us with this quality material to make our decision.

The Chair: Thank you.

Marcel.

[Translation]

Mr. Marcel Gagnon: Thank you, Mr. Chairman.

It's a little difficult to put questions to the witnesses because we are accustomed to hearing people contradict one another completely on the same issue. Earlier, in response to a question, some people were heard to say that the Agency was moving rather slowly and that there was no harmonization with the Americans. As a result of this, many US products are registered for use by American farmers whereas Canadian farmers cannot use these products. This creates an imbalance.

My question is twofold. You stated that the Agency's credibility needed to be enhanced. In my view, there is considerable work to be done on this front in order for us to know who is telling the truth and to be more or less on the same wavelength. On the one hand, you have farmers who are dissatisfied with the slowness of the process, while on the other hand, you have consumers who seem to be increasingly confused about the products they use - products which have been registered.

I realize that you're in a difficult position, but how can we get at the truth of the matter so that those on both sides of the issue are more satisfied with the Agency's work?

Before I turn the floor over to the witness, I would like to thank Mr. Chaput for speaking briefly in French earlier on. It was music to my ears.

[English]

The Chair: Merci, Marcel.

Dr. Franklin.

Dr. Claire Franklin: You raised an area that, from our perspective, is a significant challenge to all of us, and that is the availability of the many uses that are minor uses.

There's no question that when it's a brand new technical active ingredient... many of the actives that are registered in the U.S. do come to Canada. They don't necessarily come at the same time. We have some of them yes, and some of them no, but in a general sense, with the new active ingredients, now we're finding there's not as long a leg.

It used to be that a product would actually be registered in the U.S. before the registrant would even make an application in Canada. No matter how good we are or how fast we are, I can't catch up the time during which we haven't had the submission. We are seeing now, with all the activities we're doing, that the gap is getting shorter, so that's good news for all of us.

The issue with the minor uses, the expansion, is that when a product goes into the U.S. or comes to us, it doesn't have that many uses. It's what happens to it once that active ingredient is registered, and that's really where the U.S. Department of Agriculture is giving support to the U.S. growers. To take that anchor and expand it into hundreds of other users is really the area we have to work on in Canada if we're going to be able to match. There's no question that from our perspective, that is where....

We aren't hearing the same comments from the grains and oilseeds. In many cases they get the products in Canada first because the market is bigger in Canada, but it's for these smaller ones that we have this major problem.

We're actively working with Agriculture Canada. They too have recognized that this is a challenge. Hopefully we will be able to come forward in the near future with something that will be a way forward on this.

I think you're absolutely correct that this is an area that we collectively do have to work on. But I cannot emphasize enough that if the submissions don't come to us, there's nothing we, as a regulatory agency, can do about that. That's the dilemma we're in. We appear to be the major block. There's no question that there may be products you'll be able to identify where that's correct, but in many instances we don't get the submissions, and there's very little we can do about that.

That's why we are trying to work more closely with Agriculture. We're trying to have growers work with Agriculture and with registrants to really make clear the products they feel they need.

¿ (0955)

The Chair: Thank you, Marcel.

[Translation]

Mr. Marcel Gagnon: Have I no time remaining?

[English]

The Chair: Yes, you may have another round again later, but now Bob and then Dick.

Mr. Bob Speller: Thank you very much, Mr. Chairman, and welcome back.

I've had an opportunity, with a number of my colleagues, to travel across the country in the past number of months and talk to Canadian farmers and processors and different groups about the future of agriculture. One of the topics that seemed to always come up across the country was PMRA.

Certainly, if the great numbers that you put forward are reflective of what the agency is doing, you're not getting that message out to Canadian farmers, because there is a high level of frustration out there on this issue. I'm having a hard time, as David is and, as I think he said earlier, as we all are, trying to figure out what a lot of these numbers actually mean.

I'll take for example your joint registration numbers, where I think David said there were seven in Canada. Can you walk us through the process? I'm trying to understand why people aren't registering here. Is it because it's too slow? Is it because there's no market here? Can you explain to us why some of these problems are coming up?

Dr. Claire Franklin: I'll try.

Mr. Bob Speller: And let's go into joint registration. How does it work? How many applications have we had under joint registration? If people aren't applying, why aren't they applying? How does it work? As to joint registration, does that mean it has been registered already in the United States and not registered here in Canada? Can you explain how that process works?

Dr. Claire Franklin: Sure. I'm sorry, I don't have off the top of my head all of the joint reviews that we're doing, but we can provide to you a listing of the ones.... It is also up on our website. We have two programs that we deal with.

Joint review means that the registrant makes an application to Canada and the U.S. at the same time. We then divide up the submission. The U.S. reviews part of it; Canada reviews part of it. We don't re-review the same pieces of information in that. That is one major step forward. We then do the risk assessments together, so that there's no duplication nor repetition for those submissions.

À (1000)

Mr. Bob Speller: I have one little question on that. It would seem to me that if you're going to register in the United States and you had an opportunity for joint registration in Canada, most of your costs are already done there in the United States. Why wouldn't they just do it? Wouldn't you think that they would say, hey, we'll just tack on Canada too, and then we can be done with that? Is it because that makes their process a lot slower, or does it make a lot costlier?

Dr. Claire Franklin: The process is not slower. In fact there have been some registrants who have used the process, because it gets them into the U.S. system faster. There are some instances of that. The process is not slower.

Mr. Bob Speller: There are only seven, right?

Dr. Claire Franklin: There are more than seven. I apologize, the--

Mr. Bob Speller: Okay, sorry. I was just basing on what he said.

Mr. David Anderson: There are seven that have been registered jointly--traditional pesticides.

Mr. Bob Speller: This is just for traditional.

Dr. Claire Franklin: There are biologicals and there are others. I'm sorry, my chief registrar, who would have those numbers at her fingertips, was not available today, but we'll provide you with that information.

Part of it is that the registrant hasn't done the development of the field data--the residue data--with the thought in mind of coming into both countries. Some of them are actually doing more of that kind of development, as being one of the aspects they have to consider.

Market definitely has an impact. They may or may not feel that it's a large enough market to want to avail themselves of that. Those are business decisions taken by companies. But it's definitely not that it takes longer. That really is not a fair criticism of the joint review process.

The other part we do is what we call work shares. They may not come in at exactly the same time in Canada and the U.S., but there may be enough overlap so that we can actually be working together as we're doing it. There's a combination of those two kinds of activities.

Although you may feel that the numbers are not that large, I think it's quite a major change collectively for the registrants, as well as for regulatory agencies to work on this kind of process. These are not simple submissions and they're not simple processes. It does take that developing attitude to be able to use them.

Mr. Bob Speller: What's your working relationship with the Canadian Horticultural Council? These people talk to us and try to walk us through this.

They had a major report that came out in late fall or so. Have you done anything with that? Have you looked at it and said, okay, they have some problems here. Have you sat down with them and asked, how can we work this out?

Dr. Claire Franklin: We take seriously any reports that come out from associations. We have looked at that in considerable detail. A number of the points that were in the report we actually were already working on. We had met prior to that report with Ontario and Quebec ministries.

Mr. Bob Speller: But have you met with them and tried to...

The Chair: Bob, you're over your time.

Dr. Claire Franklin: We're planning to meet with the Horticultural Council, with Agriculture, within the next couple of weeks. That's the schedule.

Mr. Bob Speller: So there is a meeting set up.

Dr. Claire Franklin: I don't know of the specific date, but the intention is that it will be...

Mr. Bob Speller: Because it would important, right?

The Chair: Bob, I'm sorry, you're over. I've been a little bit generous already, and I'll come back to you.

Dick.

Mr. Dick Proctor (Palliser, NDP): Thank you very much, Mr. Chair, and thanks to the presenters.

I'd like to focus a little bit on Lindane. I think Ms. Taylor mentioned it en passant.

It's my understanding that the U.S. banned Lindane, or banned the residue from it on canola, and as a result of that, Canada then prohibited the use of Lindane. Then the company that manufactures it, Crompton, turned around and sued this country, or had a lawsuit. I don't know whether they still have.

Can somebody bring me up to date from the PMRA point of view on this?

À (1005)

Dr. Claire Franklin: Well, okay, I may be a little more familiar. Janet can jump in, if I'm going astray.

The Lindane was a very interesting situation. It was never registered for seed treatment use in the U.S. on canola. It was registered for a number of other seed uses, but not on canola. And it was then identified that, because there is a zero tolerance if it's not registered for that use, if there were any canola that was being exported to the U.S., it could be in jeopardy because of the lack of a tolerance for Lindane on canola.

The trade implications, as you can well imagine, were enormous. The Canola Council very aggressively tackled the problem, worked with registrants to ask the agency whether--well, they didn't ask us. They indicated that they would withdraw the registration of Lindane on canola, and would we process those requests in a quick manner, so that they would in fact alleviate this potential trade issue.

So that was done. The registrants that had Lindane on canola made applications to the agency voluntarily, because they had agreed with the canola growers that they would have the Lindane removed from canola seed. And we did that. The way in which that was done is that the action was taken. We also committed to do quick reviews for submissions for alternatives that would come in to the agencies, so that the growers would not be left without an alternative when the Lindane was removed. And the end date for sale and use of the Lindane, as well as the Lindane-treated seed, was July 1 of this year.

Mr. Dick Proctor: Of 2002?

Dr. Claire Franklin: 2001.

Mr. Dick Proctor: So last year.

Dr. Claire Franklin: Last year, sorry. Last year was the end. There was that phase-out.

One of the registrants, Crompton, has indicated to DFAIT that they call it an “intent to file” under chapter 11. It hasn't been filed yet, but they have indicated an intent to file. That's really just at the very early stages. It's not far enough along yet to know whether they actually will or not. That's in the process within DFAIT. That's a NAFTA challenge.

Mr. Dick Proctor: Right. So it hasn't been withdrawn; they just haven't processed it.

Ms. Claire Franklin: The challenge?

Mr. Dick Proctor: Yes.

Dr. Claire Franklin: No. They've just indicated an intent and that's as far as it's gone. It just hasn't gone any further. I'm sure that will happen in the next couple of months.

Mr. Dick Proctor: Thank you for that.

I wanted to go back to something, Dr. Franklin, that you mentioned in your opening remarks about an IR-4. If I heard you correctly, you said that it has been in place in the U.S. since the mid-sixties. You indicated that we lack this in Canada, and that does hurt Canadian growers.

Why then don't we have the equivalent of an IR-4? If it's been around for that long and it works as successfully as you seem to indicate, why haven't we done it in this country?

Dr. Claire Franklin: That is a question that you really have to ask the agriculture department.

The IR-4 program is a U.S. Department of Agriculture program that they put in place in 1963. What happens through a program like that is that they in essence are acting as a registrant. They are generating the data that's necessary to support a registration for uses that the registrant has no economic interest in pursuing.

Mr. Dick Proctor: Thanks.

The Chair: Thank you, David.

Paul.

Mr. Paul Steckle (Huron--Bruce, Lib.): I'll ask a very straightforward question, a question that came to the House a month or so ago. Why was strychnine removed as a chemical used for the extermination of certain animals? Why was that done?

À (1010)

Dr. Claire Franklin: I'll ask Richard Aucoin to address that, since he's been very active on that file.

Mr. Richard Aucoin (Acting Director, Product Sustainability and Coordination Division, Pest Management Regulatory Agency, Department of Health): Thank you.

Strychnine was actually withdrawn by Agriculture in 1992. That was the liquid concentrate form of strychnine. It was withdrawn in favour of a much safer, ready-to-use bait product for gopher control.

At the time it was withdrawn, there was a significant amount of consultation with western provinces on the issue. There was a very large number of intentional and unintentional poisonings that could be linked back to the use of liquid strychnine products. It was essentially a health and safety issue. We could withdraw the liquid concentrate form in favour of a ready-to-use product that you could buy off the shelf already mixed with the bait. At the time, there was no reason to believe that product would work any differently from a product that you had to buy the little bottle of concentrate for.

So it was essentially for health and safety reasons.

Mr. Paul Steckle: Is a ready-to-use product still available for the extermination of gophers?

Mr. Richard Aucoin: Yes, it is.

Mr. Paul Steckle: Why are gophers still a problem in western provinces, if it's been such an effective product and worked so well? If it worked as well as the other products...

A voice: It's an aphrodisiac, actually.

Some hon. members: Oh, oh!

Mr. Paul Steckle: I'm sure it doesn't just work on gophers; it works on other things as well.

Mr. Richard Aucoin: Well, it does. That is the problem. I think you've correctly nailed the problem on the head. It's very effective against dogs and burrowing owls. There have been one or two suspected human suicides with liquid strychnine.

We're not arguing that the product you have mentioned, the ready-to-use bait product, does not work very well. It appears--

Mr. Paul Steckle: Who were the bodies responsible for seeing that this was removed from the list? Was it the farmers themselves, or was it other outside parties?

Mr. Richard Aucoin: This was a decision made by the Department of Agriculture in 1992-93.

Mr. Paul Steckle: What prompted their decision?

A voice: The provinces requested it.

Mr. Richard Aucoin: The decision was made through a CAPCO committee, which was an association of pest control officials. It was a combination of the federal regulators and the provincial regulators.

It was recognized at the time that there was a growing problem with the liquid strychnine. There were numerous reports through the newspapers and from Crime Stoppers programs. The RCMP was writing letters to the department at that time. A significant issue was raised. It was discussed in detail with the federal and provincial counterparts. A decision was reached that we could go to the ready-to-use product as a risk mitigation measure.

Mr. Paul Steckle: I don't want to waste all my time with strychnine this morning, but there is another issue I want to discuss. There's a number of groups so far that are not very happy with the results of PMRA, we've heard this since 1995 and some of us have been here since that time. What can we encourage that we're not now encouraging to make this work better?

For instance, there are the horticultural groups. They come to us every year, and we hear the same story. Is it because the requests for registration, whether it's minor use or otherwise, are not made by the chemical company because of the economics of registering in Canada, because they can sell enough in the United States and we buy their finished or end product, consumer product, so that they don't have do it here?There has to be something standing in the way of this happening. What is that one issue?

Dr. Claire Franklin: In terms of the minor use, we did a pretty detailed analysis this summer and there's no question that for most of the minor uses it is not economic for a registrant to come in. They might sell $20,000 worth of product, or $50,000. Our estimate is, and it's perhaps a little simplistic... I'm not an economist, but in order to break even, back of the envelope, they would have to make in the order of $300,000 a year for it to be even remotely economic for them to consider coming forward on this.

We recognize that. I think that, as we've indicated, in the U.S. they recognize this. And if you go to the IR-4 website, the summary document, the first paragraph, states that these are not economic for registrants to come forward.

What can we do about it? I think that certainly with the analysis that we did--and really it may be a self-preservation instinct--we can't solve this problem as a regulatory agency. We have to work collaboratively with the Department of Agriculture as well as with growers.

We've certainly see a great deal of activity with growers being involved in the IR-4 program. We've in fact leveraged some trials that are done through that program that can then be utilized. That's small. That's maybe going to get maybe 10 more uses a years, 20 more uses a year. It's not going to catch us up to where the U.S. is in this situation.

We really are working very aggressively with Agriculture at this point. So any support that we collectively can put forward to move on that I think will make an enormous impact. We're going to do some other things. Mr. Speller asked if we had read the horticultural report. Yes, we read it. Some of it we like. Some of it we don't. I think that's only natural.

We're going to have a look at the point one default. The argument that we hear from many growers is that these folks from other countries can come in with their products, they don't have to have an MRL. We have a consultation document that we will put out for comment. There will be broad ramifications of that and we collectively will need to look at that. But it would put us in line with other countries; that is, that if you don't have a tolerance you cannot import produce that has that material on it.

À (1015)

The Chair: Thank you, Paul. I know your strychnine thing was... there were probably more people concerned about that today than in the letters I get.

Rick.

Mr. Rick Borotsik (Brandon--Souris, PC/DR): Thank you, Mr. Chairman. I want to follow on what Mr. Steckle said.

Your comment before about how you're working very closely with Agriculture Canada was that “in many instances we don't get the submissions, and there's very little we can do about that”. Now you're suggesting that you are in fact working very diligently with Agriculture Canada, that you're looking for at an IR-4 program, that you're going to meet with horticulture. Which is it? Is there very little you can do or are you going to become much more proactive and try to do more? That's what I think the whole issue is around this table.

If you sit back and defend your position and your department, you're not going to get a lot of support from this table or from the industry. Are you going to be proactive? You say that you're working with Agriculture. What are you doing with Agriculture? You're suggesting that perhaps we can make the IR-4 program. Have you asked for IR-4 program here? Please, answer.

Dr. Claire Franklin: Yes, I have.

Mr. Rick Borotsik: And what has the answer been?

Dr. Claire Franklin: It's being evaluated. We actually are looking at... The IR-4 program is an incredibly expensive program. They spend in the order of—

Mr. Rick Borotsik: It's $25 million.

Dr. Claire Franklin: Yes, $25 million plus.

Mr. Rick Borotsik: Have you asked Agriculture?

Dr. Claire Franklin: Yes, I have.

Mr. Rick Borotsik: And what has your answer been?

Dr. Claire Franklin: They're looking at it.

Mr. Rick Borotsik: They're looking at it. Thank you.

You haven't met with horticulture but you've read their report. Are you anticipating that you can assist hort in the minor-use registrations?

Dr. Claire Franklin: Assist work?

Mr. Rick Borotsik: Assist horticulture with the recommendations in their report. You said you accepted some, you didn't accept others. Are you suggesting that because you don't accept the others that the whole report can't be--

Dr. Claire Franklin: No, no, that's not my intention at all, and I'd like to back up a little bit. When I say there's very little we can do... I can't get a product on the market if I don't have a submission. That's what I mean with that.

Mr. Rick Borotsik: Should we simplify the submission process?

Dr. Claire Franklin: The submission process for minor use is simplified, it's in no way complicated as it is for--

Mr. Rick Borotsik: You also said that new submissions are larger and more complex, new submissions. Are you then talking about new active ingredients being larger and more complex?

Dr. Claire Franklin: Than they were in the past, yes.

Mr. Rick Borotsik: Absolutely. Is it not true that the majority of the applications do not include new active ingredients but simply existing active ingredients that are asking for an expanded label extension?

Dr. Claire Franklin: By definition, in minor use the majority of the applications are expansions of labels.

Mr. Rick Borotsik: I see.

Dr. Claire Franklin: If I could make a comment, something we are seeing that some registrants are doing, which is incredibly beneficial, is that when they come in with a submission they're not just coming in with two or three uses here and there, they're really looking at the uses that will allow a grouping to be established, and that sets an incredibly important anchor for label expansions into minor use.

Mr. Rick Borotsik: Of the 3,500 applications that you receive--I think that was the number--how many of those would be new active ingredients and how many would be existing ingredients already approved through your department for label expansion?

Dr. Claire Franklin: For new active ingredients, the way it's defined in that number, we get in the order of 50 to 75 a year.

À (1020)

Mr. Rick Borotsik: So for new active ingredients it's 50 to 75.

Dr. Claire Franklin: That's an active--

Mr. Rick Borotsik: Of the other 3,450 then existing active ingredients, it's simply for label extension.

Dr. Claire Franklin: There's a whole range of things.

Mr. Rick Borotsik: Fair ball. But they're not that complex, then, those submissions?

Dr. Claire Franklin: The label expansions aren't, but many of the others.... Label expansion is a particular application for expansion of uses. A product could be registered on apples and they want a label expansion to use it on strawberries; that's a type of application we get in. We get all kinds of applications for different formulations, we get applications for tank mixes, we get a whole range of applications.

So we're really focusing on brand new active ingredients, of which we get in the order of 15 new technicals plus the associated end-use products, which is what makes it the 50 to 75 that we get, and label expansions. Those are the only two pieces we're talking about.

Mr. Rick Borotsik: We talked about the IR-4 program and it seems that maybe it's got some potential to help us with the funding of the front end of these applications.

Dr. Claire Franklin: Yes.

Mr. Rick Borotsik: Now that you've heard around this table that there are a lot of organizations out there that do not see your organization as being terribly operationally fit, are there any other proactive changes you have identified and can think of that you can move forward with? And I'm thinking of simplifying the application. I'm thinking of perhaps the ombudsman that Rose-Marie talked about. You have some difficulties in your operation. Have you not looked at trying to improve that in some way, shape, or form?

Dr. Claire Franklin: We're constantly looking at trying to improve. It's a complicated process. We have significant responsibilities. We have to ensure that the health of Canadians is protected; we have to ensure that the environment is protected, and we have to make sure that these products work. These are not uncomplicated aspects that we have to consider when we're bringing a new product into the country. So we are constantly looking to see how we can improve that, there's no question.

Mr. Rick Borotsik: Are there any applications that come in that are totally complete? You had mentioned, and somebody had mentioned, that the ones that are not complete then go back, they're recycled, they go back through the system. On a percentage basis, how many actually come in that are complete right from the get-go and go through the system? Is it 10%, 15%?

Dr. Claire Franklin: I mentioned this year of the ones that we registered, five. We registered 13 new ones this year, so that's a remarkable improvement.

Mr. Rick Borotsik: But were they complete when they first hit the table?

Dr. Claire Franklin: Yes.

Mr. Rick Borotsik: They were never bounced back, they did not cycle.

Dr. Claire Franklin: No, they did not cycle.

Mr. Rick Borotsik: How many applications were there? Other than the 13 approved, how many were there?

Dr. Claire Franklin: For new technicals we get probably about 20. That year we had 13, so five out of the 13 were okay right from the beginning.

Mr. Rick Borotsik: Five out of 13.

Dr. Claire Franklin: Yes. That's great, that's good news.

The Chair: Before I move on to--

Dr. Claire Franklin: Then when it was zero--

Mr. Rick Borotsik: That is 13 out of 13.

Dr. Claire Franklin: Yes, absolutely.

The Chair: Dr. Franklin, before I go to Mark, I hope we don't lose sight of what the purpose of your agency is. We've had a lot of concerns about why we can't get things faster onto the market. Why can't we get these things approved? In terms of, we'll say, the last three years, how many applications have simply been turned back because they're not acceptable in terms of our Canadian health system and our Canadian environment?

Are you protecting things? Or are you just impeding things? That is what I'm asking. Could you just give our committee, before I go to Mark...?

Dr. Claire Franklin: You sound like someone else.

The numbers that we have in 2000 for the positive decisions we were able to take for the submissions was 86%. This means 14% were turned back. We rarely turn back or don't register completely when a new active ingredient comes in. Fortunately, by the time they come to regulatory agencies, most registrants have sorted out whether they have a registerable product or not, so that their checks and balances are such that we don't see that.

We have had a few. I'm not at liberty to identify those. That's the challenge. But we do see in many instances that there may be restrictions. The application rates may not need to be as high as are originally requested. That's beneficial to the environment, to health. People aren't exposed if the levels are lower. We may not see as many uses as come in initially, because there may be problems.

Within a submission there are pieces of action that are taken that do reflect the fact that we are mindful of protection of health and the environment. Sometimes they don't work very well, or they may not work for a particular expansion that's being considered. So those are aspects that we would take into consideration.

À (1025)

The Chair: When you used that last sentence, it disturbed me: “they don't work very well.” So the farmers have some assurance that the product as it passes your agency is going to work. Is that what you're also saying?

Mark, can I go to you then?

Mr. Mark Eyking (Sydney--Victoria, Lib.): Thank you, Mr. Chairman.

As a grower who has travelled across this country in the last year, I've come to a conclusion. The system we have in Canada is flawed. I think you are doing the best you can for the mandate you have and the tools you have to work with. But Health Canada's mandate should be more focused on--and you mentioned it--keeping Canada and Canadians healthy through monitoring the environment and the things they ingest.

Because all the products we consume from all over the world, especially the U.S., and all the products we sell to them... I want your opinion, Dr. Franklin. What would be the problem with changing the whole system a bit, where Agriculture Canada would see what the United States is doing, see what new products they're using, analyze that, put into the equation a bit that we have different climates and different soils, and then tell the farmers what they can use?

Health Canada should be monitoring the products that we are eating from all over the world, whether it's grapes from Chile or lettuce from the Holland Marsh, and if there's a problem with it, if there's too much residue, or it's going to be a problem, raise the flag and tell Agriculture Canada there's a problem. That's what they're doing in Europe. They're getting really close to the situation where what you spray and do in Germany is very similar to what you do in France and Holland. What is the problem--and this may be a big debate here--with changing the whole system, except that some of you may lose jobs or have to work for a different department? I want to put that to you.

Dr. Claire Franklin: You're right. It's not a new question. I would comment that in fact in Europe each country does have its own registration process. Germany registers. They have their own process. France has their own process. The umbrella they have over all of that, which is another layer, is the EC and the directives that are put out by the European Commission. So it is not correct that automatically if it's done here, then it's done there. They have a similar process.

Worldwide, to the best of my knowledge, there is no country that automatically says if it's used over here, we're going to use it over there. I don't think the people of a country are well served under those circumstances.

Mr. Mark Eyking: I don't think we should rubber stamp either. Don't get me wrong.

Dr. Claire Franklin: We work together not only with the U.S. but with European countries as well. Over the past several years, a remarkable change has been that regulators internationally are talking together. They're trying not to have impediments that are really scientifically inappropriate. There is a great deal of that kind of activity to look to see what's being done, and then to put in what's unique in the particular country, in which the product is being used. This really does have to be taken into considerable attention.

Mr. Mark Eyking: But is there a danger for our consumers in overhauling the system?

Dr. Claire Franklin: It depends on how it's overhauled. If it's overhauled in such a way that it's not considered to be protective, then yes, you're going to lose the confidence of the public.

We have overhauled the system. We've taken a system that had multiple departments involved, where in fact it was incredibly challenging to have reasonable timeframes and decisions that would all focus on the same product at the same time. Most countries that have had this kind of process have actually gone to having single agencies, recognizing that you have really to balance all of the factors. But very few countries are not either at a single agency approach or are looking toward getting to that, because there are definitely efficiencies that come with it.

À (1030)

Mr. Mark Eyking: I have just one question in closing.

As a grower, my conclusion is, if things don't change--and maybe they're in the process of changing--I can see us not growing a lot of crops, especially smaller crops, because growers are not going to be able to. They're just going to come from another country and be tested. I think if that doesn't happen sooner than later, that's what's going to happen. We're not going to be growing a whole lot of these crops. I don't know how you feel.

Dr. Claire Franklin: We're mindful of this concern, and certainly it's neither our nor Agriculture's intention that we would see that outcome. I would really like to comment that we are definitely trying to see if we could do something that would assist in that respect, because that's not the intention of us as an agency or of Agriculture.

The Chair: Thank you Mark.

Howard.

Mr. Howard Hilstrom (Selkirk--Interlake, Canadian Alliance): I have a quick comment. I don't buy into this ombudsman thing. The minister is responsible. Department heads are responsible. And production is what counts in this business. It's a real world out there, and farmers need to make money.

Having said that, in a rhetorical question, do you get the feeling--I hope you do--that in fact you have 10 MPs here who don't believe we're getting the full story? It's quite clear that the health minister--the past one, the present one, and this government--is intentionally using bureaucracy to slow down and stop new registrations and fixing this system because of a philosophy. For example, Mr. Caccia brings forward these reports that all chemicals, all pest management products, are bad; the risk is unacceptable, so out of a precautionary sense, don't use any of them. I'm asking you this. Do you believe you have political interference that is causing your departments to not work efficiently and effectively in getting the job done?

Dr. Claire Franklin: I've been in government in regulation for a long time. In my experience, I have not seen political interference when it comes to making decisions on products that we're registering. From my experience, that is not the case.

Mr. Howard Hilstrom: Would you recommend this go back to the Department of Agriculture, for PMRA to be administered by the agriculture minister? Would you recommend that?

The Chair: I'm afraid that's not a fair question.

Mr. Howard Hilstrom: Is that not a fair question? Okay, I'll pass on that then. I agree. Let's get down to specifics.

Dr. Claire Franklin: Could I also respond to your comment about not taking decisions because of concern about that. As I indicated earlier, we as an agency are registering twice as many new active ingredients as were registered before. That's under the Minister of Health. We need to be very mindful that there is nothing to indicate that there has been any attempt to thwart registration of products.

Mr. Howard Hilstrom: As members of Parliament, we get lobbied and pressured from various groups, including the farmers and associations, that things aren't working. That's why we're really pressing you folks here today.

Let's deal with the last little example here. Minister Oscar Lathlin from Manitoba--natural resources and environment--says that in regard to cyanide for the use of predator control he sent a request down here to have the use of this product in Manitoba. He wrote in his letter that you folks lost all the paperwork on that. Is that true? This was within the last year.

Dr. Claire Franklin: Richard, could you comment on that?

Mr. Richard Aucoin: We received an application from the Manitoba government. I believe it was at the end of December.

Mr. Howard Hilstrom: Did you lose it, or do you still have it?

Mr. Richard Aucoin: We have it.

Mr. Howard Hilstrom: Is cyanide going to be put back on for use? We have a massive problem on the prairies, not only with gophers, but with predator control of coyotes and wolves.

Mr. Richard Aucoin: We're both aware of the problem. The actual application is currently under review.

Mr. Howard Hilstrom: It's been a year and a half since we've been able to use that product. Professional natural resource people use cyanide, not individual farmers. Farmers can't even have it. So when can we expect that will be approved?

À (1035)

Mr. Richard Aucoin: I can't answer the question. The application is under review. I don't think it's going to be a lengthy process, but it was just received at the end of December.

Mr. Howard Hilstrom: Okay. Well, we're getting some action on it anyway.

The last point I'd like to make is you say all your processes don't cost the farmer any money. The fact of the matter is, all the costs of these regulatory processes and fees are being passed right through to those farmers and ranchers. It's not only those fees; it's the lost income opportunity by not having pest management products available that are being used 50 feet across that forty-ninth parallel, beside the Canadian field.

Harmonization is more important than you folks maybe understand. We need to have this continental North America concept of agriculture in place really soon, including this PMRA. That's why I say maybe it's time the PMRA went back to Agriculture for administration.

I guess those are more comments than questions.

The Chair: You're scaring the heck out of the chairman here when you talk about cyanide and strychnine and these other things.

Mr. Howard Hilstrom: The crop insurance of Manitoba paid out over $360,000 on pest and predator control last year. Now some of that was due to birds eating crops and that, but a lot of it was because coyotes were eating calves and sheep. I hate those sheep, but...

The Chair: Barbed-wire fences.

Murray.

Mr. Murray Calder (Dufferin--Peel--Wellington--Grey, Lib.): Thanks very much, Mr. Chairman.

I'd like to go back to this joint registration you were talking about. I know some of the companies that have been involved in that have got out of it. I was wondering why they decided to get out. Is there something wrong with the process, or what was the reason?

Dr. Claire Franklin: Do you know specifically which company has gotten out of it?

Mr. Murray Calder: Not right off the top of my head, but I have talked to some people--the horticulture people, for instance--in my office who have said some companies that were in the joint registration have decided to get out of it. I was just wondering if you could comment on that.

Dr. Claire Franklin: It would certainly be helpful if I knew specifically which company had indicated that to the Horticulture Council. We certainly haven't gotten that impression from the companies we've worked with. In fact, I think there's been definite benefit to the ones that have worked with it successfully. We would definitely be interested in knowing if a specific company has indicated that to the Horticulture Council. We also would be interested to know if there was a specific reason.

This is a process we're trying to make work, so it would be helpful for us to know what the problems might be so we can collectively try to fix them. As was previously pointed out, we have to consider North America as a single market. We get into so many other problems if we have registration on one side of the border and not on the other.

Mr. Murray Calder: There is also a clay product for apples I was talking about the last time you appeared in front of us. At that time, you said the permit for research had been applied for and they had not applied for registration. Has that happened since then, or do you know what the status of that is?

Dr. Claire Franklin: To the best of my knowledge, they have not yet applied. I went back after that discussion to have a look at the activity on that. We will certainly speak with the registrant to clarify any misconceptions they might have, but we do not have an application in yet.

Mr. Murray Calder: Thank you.

The Chair: Thank you, Murray, for some very short questions.

Marcel.

[Translation]

Mr. Marcel Gagnon: Thank you.

I don't believe you answered the second part of the question I put to you earlier, although you did briefly allude to the issue when you pointed out to others that health and the environment, not agriculture, were among your main responsibilities. I can understand that and this ties in with the second part of my question. I asked you what could be done to enhance your Agency's credibility with consumers. Increasingly, as I was saying, consumers are questioning the products used for agricultural purposes

As I side bar, I was active for many years in the field of farm trade unionism in Quebec and I always believed that the agricultural industry would be healthy when consumers had confidence in the products produced. The two go hand in hand.

With a view to enhancing the Agency's credibility, what steps can be taken to ensure that consumers have confidence in the Agency's decisions and believe that products are safe from a human health and environmental standpoint?

À (1040)

[English]

Dr. Claire Franklin: Thank you, Mr. Gagnon, for the question. It is a challenge for all of us. I think a lot of the public confidence--or lack of confidence--focuses on older products. Many of the issues that come up where there are public concerns raised are because of products that have been on the market for a long time. There may be regulatory action taken in another country, so the question then is why are we not taking the action in Canada. That's really why we aggressively positioned that we needed to have an active re-evaluation program, and the government did put in additional resources so we would be able to do that.

So I think that's a very key one, and it's why we're working very closely to try to ensure we at least know the basis for decisions that are taken in other countries, and if they need to be taken here, that we're in a position to do that.

I think that is where a lot of the confidence has been eroded with some of these products. It doesn't mean the products are bad, and there's a lot of misunderstanding or misinformation, but that's a reality we have to deal with.

We've had very good cooperation with registrants for new technical actives when we put new products on the market. We actually put out a summary document, which is the basis of the decision, for consultation prior to the decision. That, in our view, is one way the public can see the basis of the decision we took, what goes on with that particular product. That we're able to encourage that level of openness is, I think, really very important.

The other piece that I don't think gets as much profile as might be helpful is the fact that the vast majority of produce that Canadian consumers eat has no detectable pesticide residue on it. I would venture to say that many Canadians believe every piece of produce, every apple they eat, is laced with every single pesticide that's registered for use on that particular product.

So I think that would also help, because in many cases there is a concern that if it's used, it's going to be there. And we all know that in many cases, even though they can be there, the levels are actually not there at the time it gets to the consumer's plate.

I think those are some of the areas that would perhaps help strengthen public confidence.

The Chair: Thank you, Marcel, Dr. Franklin.

Dick.

Mr. Dick Proctor: Thanks very much, Mr. Chair.

Dr. Franklin, you indicated in response to Mr. Speller that you had read the Canadian Horticultural Council's report from last November. I just want to quote from that and ask you to comment. This is on the user-requested minor-use program: “Currently there are approximately 130 active ingredients registered or pending in the U.S. to which Canadian producers do not have access. A major change in attitude and approach is needed to facilitate access to products through the URMUR program.”

I think it's implicit in the second sentence that they're talking about the change in attitude on the part of your agency. I'd like you to comment on that.

Dr. Claire Franklin: All right. I'll ask Daniel to comment on the URMUR.

Mr. Daniel Chaput: URMUR is one of the programs we put in place to facilitate access to minor-use products. Basically, there's an expedited review time of 12 months versus 18 months. You're talking now about a new active ingredient to Canada, something we know nothing about, and the expedited review is done on the basis that we use the reviews from EPA. Instead of redoing them, we use the data evaluation reports from EPA to make our decision.

There have been close to 15 registrations under the URMUR, so clearly it does work. The application fee is significantly reduced for URMUR. We have to keep in mind that the new activities are the most complex submissions that come in.

But there's still a need, I guess, for a minimum level of interest from manufacturers. It's a program that works in cooperation. The manufacturer and the growers work together on putting the submission together.

It has worked. As I said, there have been about 15 registrations, so there has been success.

À (1045)

Mr. Dick Proctor: So you would disagree with their comment that a change in attitude is required?

Mr. Daniel Chaput: In the URMUR, we've been very flexible in terms of working with the registrants and growers to bring them together and have some cooperation. And there have been registrations granted in these cases.

The Chair: Rick.

Dr. Claire Franklin: Mr. Chair, could I just make a quick comment on that point?

The Chair: Yes.

Dr. Claire Franklin: A number of the companies are actually using that program, so I would venture to say we'll see more products coming in that way. In the past, it wasn't particularly well used, and I think some of the comments are really reflective. We actually have many more applications in under that now than we had previously. But the registrant has to be involved in it, as well. It's quite different from the URMULE. It's quite different from a label expansion one. The registrant definitely has to be involved in those.

The Chair: Rick.

Mr. Rick Borotsik: Thank you, Mr. Chairman.

Ms. Taylor, you mentioned a re-evaluation consultative process that you had with the registrants. You said there's a document that's prepared to go out with this re-evaluation.

Can you do two things? Can you explain to me what it was you were trying to achieve with this re-evaluation consultation? Secondly, and probably more importantly, why are the registrants not signing off so that document can then become public?

Ms. Janet Taylor: What we were trying to achieve was to summarize for the public the kinds of reviews of the basic supporting data packages we had done, to develop risk mitigation measures where we had seen risks, and to identify what we considered uses of the product that could be eliminated and uses that were required. The mitigation measures included--there's a limited number--measures to protect workers, for example, protective clothing, closed application systems, and that sort of thing and measures to protect the environment, such as buffer zones around bodies of water.

Then other measures, more general ones such as... in many cases we've found that the actual use pattern could probably be changed to lower the rates and number of applications. What we wanted to do with those consultation documents was put them out--the ones we've worked on to date are between 20 and 40 pages, so they're highly summarized pieces of work--so everyone could have a look at them. The general public would know that we are reviewing toxicology data, we're considering the health of children, we're looking at residues on foods, and we're doing the risk assessments--aggregate, and we will be doing cumulative.

We also wanted to have them in the hands of provinces and users so they could verify the information on the uses and determine whether or not they had alternatives for some of those uses, and also so they could provide feedback on the practicality of some of the mitigation measures that will impact on them. For example, closed systems is a route the U.S. is frequently taking with the organophosphate insecticides--closed mixer/loader systems and closed application systems. Some of these things, we're not so sure how practical they are, how broadly across the country they're implementable, how long that would take, and that sort of thing. It was really very important to us have that kind of feedback.

Why are the companies not signing off? I really can't answer that question. The information we're providing in these documents is in, I think, much less detail than the information that's provided on the EPA website for each of these active ingredients. They publish every one of their reviews on the toxicology environmental data. They publish all their proposals. We are essentially publishing a summarized document because we just don't have the resources to do those big documentation exercises. I can't understand why we're not getting sign-off. It's a major roadblock to completing our program, and we're going to have to find a way around it. We've always sent these letters out that said, in case there's confidential business information, would you please read this document and sign this letter allowing us to publish.

Right now the only route I can see is to see what really is confidential business information, to really verify that, and to see if we can't go out with a major part of the document, if necessary scrubbing whatever stray bits of confidential business information there are. This does make a less comprehensive story when you put the document out, but if we have to live with that, we have to live with it. These documents are really important to us to come to final regulatory decisions. One of the things we're finding is that we don't always have the same uses in Canada as in the U.S., and how to deal with that situation is really important in order to involve everyone. That's really the basis.

À (1050)

The Chair: Thank you.

Rose-Marie.

Mrs. Rose-Marie Ur: Dr. Franklin, you had indicated in your presentation that companies that can't earn at least $300,000 a year find it better not to get involved in a minor-use application if they can only make $20,000 or $30,000 off a chemical for a small-acreage product here in Canada. That being said, if there is such a minor-use product necessary for our Canadian farmers and because the end product eventually gets to Canada with that product on it, do you think it would be possible under our system to then have some kind of venue where those products that are used in the United States are allowed to be used by our Canadian farmers? Could there not be some kind of waiver or something like that? Human nature being what it is, some of those chemicals probably do come across the border.

Dr. Claire Franklin: They may. Certainly the point one... there may be some levels. We are actually trying to do as much of that as we can. The information we require to make the decision is really very limited when it comes to minor uses, and we will use the information if it's been generated in a part of the U.S. that's similar. I think we're going as far as we're able to go. There are just some uses in parts of Canada where we don't really have the kind of information we can use.

The testing requirements and all that really aren't all that expensive, but it's just not considered by a registrant to be economic. As I say, most other countries are really trying to bridge that sort of gap as to the amount of information that is truly justifiable and having a program like that to support the generation of that.

Mrs. Rose-Marie Ur: Do you think our scientific community here in Canada would really have a problem with this if we went that route?

Dr. Claire Franklin: Which route--to automatically accept without having a look at it?

Mrs. Rose-Marie Ur: Right.

Dr. Claire Franklin: I believe there would be people who would... because we do see it in some instances. Our climatic and soil conditions are sufficiently different that, if it's a product that does happen to stick around for a while, there can be differences.

Mrs. Rose-Marie Ur: I'm going to play the devil's advocate here--surprise, surprise.

Dr. Claire Franklin: Yes. I'm getting to really know you well.

Mrs. Rose-Marie Ur: Well, that's good. I came to do a job well, not necessarily to make a lot of friends. But I appreciate working with you.

The thing is, we have a lot of snowbirds who go south, and they live there--

Dr. Claire Franklin: The actual birds or the people?

Mrs. Rose-Marie Ur: The people.

Dr. Claire Franklin: Because both occur.

Mrs. Rose-Marie Ur: I'm not into birds. I'm into people right now. Those individuals eat the awful food down there on the awful soil in the awful climate, and I don't think we have a lot of people terribly, terribly ill from the chemicals they consume on that product down there.

Dr. Claire Franklin: If I could just comment, the information we require does not assess the toxicity of the product. We're requesting information on whether there is more residue left on an apple grown with this product in Canada than on an apple grown somewhere else, or a peach or whatever. We're really trying to make sure that when it's used according to label directions the residues left are not going to be different. This is a fundamental factor.

We're not saying they have to provide toxicology information, because you're absolutely right, it's a fundamental aspect with that. Really it's whether we've done something because of our conditions that leaves more on the product, more in the soil, than you would see if this information was generated elsewhere.

À (1055)

Mrs. Rose-Marie Ur: May I have one last question?

The Chair: Okay.

Mrs. Rose-Marie Ur: This is very important, that's why. This is a climax, Mr. Chair, so I have to--

The Chair: All right.

Mrs. Rose-Marie Ur: Everyone is on their seat.

Does the PMRA intend to revise Canada's default residue tolerance level for imported foods to 0.0 parts per million from the current 0.1, and if you do, when?

Dr. Claire Franklin: As I mentioned to the rural caucus and earlier today, we were just trying to tidy up the document that we will put out for consultation. We're definitely prepared to look at it. We'll need to have input from a wide range of people; it may fix one piece and make another a little more difficult. I think it will be useful to have this kind of dialogue and we're prepared to go with the conclusions we'll gain from this type of consultation.

Mrs. Rose-Marie Ur: How long is this consultation?

The Chair: Rose-Marie, okay now.

Mrs. Rose-Marie Ur: I'm pushing it? Okay.

The Chair: We have two quick questions here and it's almost eleven. David and then--

Mr. David Anderson: I have another comment on the strychnine and then my question. You are going to get a lot of noise from western Canada to have that approved again this year, whether it's an emergency use or a regular registration. If you do, it needs to be delivered differently from last year. Farmers are expected to take a barrel of oats and then drive 90 miles to a distribution point to have the government official mix their chemical for them so they can go back home and treat their gophers. This is totally unrealistic. It makes people angry. We haven't been treated this way since the 1930s, so take a look at that, please.

At the beginning of your presentation you said your aim is to prevent chemicals from entering or remaining on the market if they shouldn't be there. Secondly, you said that health and environmental protection is the priority and chemical registration is second. I've heard it suggested that your department has an imbalance, if you want to call it that, a fixation on health and environmental issues that's affecting your ability to do a good job in the pesticide registration area. I would like you to talk about this.

If it's true, I think it would explain some of the things we've talked about today, like the reluctance to use companies' data in registration. There seems to be some reluctance to use U.S. data. We've talked before about the reluctance to go to geographical regional areas for approval. There's some reluctance, obviously, to de-harmonize. I'm really concerned this morning because I don't see any indication that you feel you need to change an attitude, or any of the ways you do things, to improve, yet we've consistently heard this over the past while.

I want you to talk about this a bit, if you feel there's an imbalance that needs to be corrected. I understand that health and environment are important, but from what I'm hearing this is beginning to impede your ability to do your job, when actually, if you were doing it more quickly, it would be improving the health and safety of Canadians because those less toxic products would be on the market.

The Chair: David, I'm going to take that as a statement rather than a question because our time is very short.

Mr. David Anderson: It's a good statement, though.

The Chair:And I want to get to Dick, because he has been patient and the hour of 11 is approaching.

Mr. Dick Proctor: It actually wasn't on PMRA. I wanted to talk about future business.

This is our last meeting, as I understand it, before we actually begin our western meetings. We started a discussion a couple of weeks ago about witnesses and then we went off on a tangent about the Minister of Agriculture. I don't know where we are at all.

The Chair: Perhaps we could stay for a minute or two afterwards.

Mr. Dick Proctor: Okay.

The Chair: So I'm not sure, David, if Dr. Franklin could answer that question in about a minute. You made a very broad statement.

Mr. David Anderson: If it's a philosophical problem that you have going on in your department, that explains why so many of the problems that are being raised are coming forward. And I would like your reaction to that. I expect you'll say there isn't one, but it seems to me there is something causing this general corporate problem within your agency, and I'm wondering if that's what it is.

Dr. Claire Franklin: I believe my earlier statements would answer that. We don't have a corporate problem that prevents us from making the decisions that we're supposed to be making under the Pest Control Products Act.

We review safety, merit, and value on a product that comes in; we make a decision on that, based on the best science available, and then we make a decision. And the fact that we're registering more products than were registered when the process was within Agriculture Canada does not support a conclusion that says we have a fundamental problem in making decisions on products.

Á (1100)

The Chair: With that, I'd like to conclude this part of our meeting this morning.

We'd like to thank you, Dr. Franklin, and your staff for coming. I guess you understand some of the frustrations.

Someone has mentioned an ombudsman. When members of Parliament go around their constituencies they virtually are ombudsmen to the many people who get frustrated with the process. And I think it's reflected here somewhat this morning.

We certainly would hope that somehow communications will improve between your agency and our farm community. Perhaps you've also gleaned some of our ideas that might be considered in terms of your future working. And hopefully farmers and agriculture people can benefit.

So thank you, and with that, we'll adjourn this meeting.