Agriculture Committee on June 8th, 2006

[The Chair, Conservative, Gerry Ritz]

Good morning, ladies and gentlemen. Thank you for your attendance here today.

We'll continue with our meetings. This is number eight, our biannual appearance of the Pest Management Regulatory Agency.

Welcome, Ms. Dodds. You have a presentation, I understand. You have an hour here, with some questions to follow.

We have a bit of a mixed bag today. There are a lot of comings and goings at the committee, so bear with us.

Please begin.

[Karen Dodds, Executive Director, Pest Management Regulatory Agency]

Thank you very much for the opportunity to appear before you today and to provide an update on the activities of Health Canada's Pest Management Regulatory Agency since we were here last June.

As requested by the Standing Committee, I have submitted a report that indicates the number of new pesticides approved, the number of older pesticides that were re-evaluated, the number of minor use pesticides that were approved, the number of temporary and emergency registrations, our cost-recovery figures and staffing requirements. I or my colleague Richard Aucoin, the Acting Chief Registrar, would be pleased to answer questions on this material. I would also like to take this opportunity to highlight some of our work and achievements that we believe will be of benefit to Canadian growers.

Shortly after our last appearance here, within the agency we established some priorities for ourselves. An important one for the agriculture sector is the commitment to improve relations with our stakeholders. I've tried to meet with grower groups from across the country to learn more about the concerns they have regarding pesticide regulation in Canada. I met separately with the grain and forestry industries in December, the Conseil québécois de l'horticulture in January, the Ontario Fruit and Vegetable Growers' Association last summer and again in January. We've had regular meetings with the Canadian Horticulture Council, and I've travelled to Alberta and B.C. and met with a variety of grower groups there.

These meetings have really been helpful in improving my understanding of their experiences and the challenges regarding the availability and use of pesticides. I've also provided them with information on our priorities, and received a great deal of helpful information on how we should proceed in achieving them.

In collaboration with growers, we are working on removing regulatory barriers, prioritizing the evaluation of products for minor crop uses, and looking for ways to improve access to new products already available to their U.S. competitors. Bill C-28, which received royal assent last fall, will make the Canadian process of setting pesticide maximum residue limits more efficient. This will allow pesticide maximum residue limits to be established directly under the new Pest Control Products Act, rather than having to go through a regulatory process under the Food and Drugs Act, which currently can take 12 to 24 months to come into effect.

With the new process, we could establish an MRL in as little as three months, allowing farmers likely to use products at least a growing season ahead of time.

We had a very productive session with growers during our first national crop protection meeting in March of this year, which we co-hosted with Agriculture and Agri-Food Canada and the Canadian Horticulture Council. During that meeting, we announced some initiatives we believe will be helpful in closing the technology gap that currently exists between Canada and the U.S. These initiatives are largely based on our ongoing regulatory cooperation with the U.S. Environmental Protection Agency, or EPA. We announced we are streamlining data requirements for residue trials.

In two locations we have amalgamated subzones, so we will no longer differentiate subzone 5 from subzone 5b or subzone 1 from subzone 1a. This provides more flexibility in deciding where required residue studies are located while continuing to maintain a high degree of protection against excessive residue limits for pesticide-crop combinations grown in those regions.

We are developing ways to register more minor crop uses in Canada in a shorter timeline. By making greater use of existing foreign reviews, which we can do more of in an internationally harmonized regulatory environment, we can significantly reduce the timelines for arriving at a regulatory decision.

For example, we are piloting the evaluation of some active ingredients of significant minor use interest based on the U.S. EPA reviews of these active ingredients, which are similar to program one under our re-evaluation program. These evaluations would be done by teams dedicated solely to these submissions.

We expect this innovative evaluation method will result in a regulatory decision in six months, rather than the standard eighteen months.

Additional incentives, such as extended data protection granted for minor use registrations, are also under consideration. Any revisions to the User Requested Minor Use Registration or URMUR program based on the outcomes of the pilot project will be made in consultation with the grower and industry communities.

As you see, we're continuing to seek ways to further harmonize with the U.S. EPA in order to keep closing the pesticide technology gap that can hinder our growers' global competitiveness. We're also continuing to increase our capacity to cooperate on the evaluation of new products and the reassessment of products already on the market, whether it's through joint review or sharing of the evaluation work.

This year, four out of twelve active ingredients, or 33% of new registrations, were joint reviews. When manufacturers take advantage of the joint review program and submit the application for registration to both countries, we can bring new products onto the market at the same time in both countries.

Under the NAFTA technical working group, we also have agreed to a 25% reduction in the number of field trials required for a joint review. I've heard estimates that this will save the industry up to $1 million per active ingredient under the joint review program. That's a very positive incentive for industry to use joint reviews.

It's not just with the U.S. We anticipate an expansion of the joint review work through the Organization for Economic Cooperation and Development over the coming years. Richard has been working with colleagues on the first global review, which I think is due for receipt this fall.

We are moving forward with the revocation of the default 0.1 ppm Maximum Residue Limit for pesticides, in favour of setting specific MRLs for each pesticide/crop combination registered in Canada. The US residue limits, or what they call tolerances, that have been established after the US Food Quality Protection Act went into effect will guide the establishment of these new specific MRLs for Canada, thus harmonizing with the US more closely. We'll be releasing another document on this topic for consultation with stakeholders in the very near future.

Using the U.S. tolerances and adopting them wherever possible both moves us forward in harmonization and favours farmers in having access to the same product.

As some of you are aware, the experience with the own-use import program since 2005 raised a number of divergent issues that we felt needed to be addressed. Growers want access to pesticides that are priced similarly to those in the U.S., while manufacturers want assurance that their investment in the data used to support the registration of their products is protected.

In the midst of that, there were also concerns about the potential impacts on human health and the environment from things such as improper container disposal. To resolve these and other issues, the PMRA formed a task force that represented a wide cross-section of stakeholders, including a number of growers, the pesticide industry, health and environmental organizations, and officials from federal and provincial governments, to identify the issues and to work through them.

The task force has met 13 times since November of last year, and I am pleased to say it is very close to consensus on a package that will provide growers with access to competitively priced products while simultaneously achieving data protection for manufacturers. The task force is looking at ways of ensuring ongoing access to own-use importation in a way that will address all of the key issues identified.

In the past year, one of our main priorities has been the coming into force of the new Pest Control Products Act. The new Act is based on three key principles: strengthening health and environmental protection, making the pesticide regulatory system more transparent and strengthening the post-registration control of pesticides that are already on the market.

The work related to bringing the new act into force has been very significant, and work on new regulations continues. For example, four sets of proposed regulations were published in the Canada Gazette. These included proposed regulations for safety information; adverse effects reporting, which we're now calling mandatory incident reporting; sales information reporting; and revised and updated pest control products regulations. Comments received after Part I publication in Canada Gazette have helped us to refine the proposals. The updated Pest Control Products Regulations we expect to be published in part II soon, and the act will soon be in force.

Perhaps the most significant changes in the new Pest Control Products Act are provisions for increased transparency and public participation in the pesticide regulatory system. Under the new act, growers themselves will also be able to access information on applications made for new products or new pesticide uses, as well as the estimated timeline for registration. This increased transparency in the regulatory system will be useful to growers when they go about planning. It will allow them to start considering at a much earlier timeframe the additional minor uses they might like to have related to any particular registration application.

A couple of weeks ago PMRA officials, Canadian growers, and industry representatives participated in a meeting with their counterparts in the U.S. At this meeting they committed to exploring a common label for pesticides sold on both sides of the border. A short list of candidate products was established, and Canadian and U.S. officials will work on the elements to make the common NAFTA label possible.

With a common label for pesticides sold in NAFTA countries, pesticides would be able to move across borders more easily, thereby evening the playing field among NAFTA partners and making them more globally competitive. This is an initiative growers have looked at with great anticipation, and the pesticide industry CropLife members are also doing a key part there.

Looking ahead, Health Canada's vision for pesticide regulation is to continue to work towards a more open and transparent regulatory system that is responsive to the needs of growers and more predictable. This will be more helpful to growers as they make their business decisions. In addition to that, we will continue to make credible, science-based regulatory decisions that are protective of human health and the environment. We will also strive to make better linkages with our stakeholders, provincial/territorial governments and international counterparts.

In closing, I would like to say that we hope our already productive dialogue with the agriculture sector and growers continues to be fruitful in the next year.

[The Chair, Conservative, Gerry Ritz]

That's a nice choice of word, that “fruitful” thing. Horticultural guys love it. Thank you so much for your presentation.

Mr. Aucoin, do you have anything at this time?

[Richard Aucoin, Chief Registrar, Pest Management Regulatory Agency, Department of Health]

No, thank you.

[The Chair, Conservative, Gerry Ritz]

We'll start with the opening round of seven minutes.

Mr. Easter will begin.

[Wayne Easter, Liberal, Malpeque, PE]

Thanks, Mr. Chair.

Welcome, Karen and others.

I would say in the beginning that I think your outreach program, for lack of a better word, is being productive. We're hearing much better reports back on PMRA than we heard a couple of years ago--and that's not due to the new government, Mr. Anderson; that's due to PMRA's outreach program. I think that's really good.

On page 3 you talked about the pilot project basically harmonizing the regulatory environment and regulatory systems. Does that just involve the U.S., or does it involve Mexico as well? Can you give us a little more detail? Is it the intent to basically move to a much more harmonized system between the three countries? If so, do you expect to make that pilot permanent, and if so, when?

[Karen Dodds]

For clarification, I will say a few words about our work under NAFTA and then I will turn to Dr. Aucoin to discuss the pilot, which is referring to some minor uses and builds upon our NAFTA work.

We have made considerable progress under the NAFTA technical working group; that is, Canada, U.S., and Mexico. It isn't really an even threesome. Mexico is there. Mexico has recently developed its own law and regulation and is still sort of feeling its way as to how it can work in the NAFTA context. But it's involved very much in our discussions, and one of the big benefits of that NAFTA forum is it doesn't impede close work and progress between Canada and the United States.

The NAFTA work has evolved from first looking at things such as what the data requires and working to harmonize the data requirements, which is a big benefit for the industry, to considering how we evaluate the data, making sure criteria are consistent, all the way to this program of joint reviews.

A number of us think the program of joint reviews is a very solid point for the future. What's really happening is that the companies are bringing a submission to both the U.S. and Canada at the same time. We divvy up the submission and it's agreed that Canada will review certain aspects of the file and the U.S. will review other aspects of the file, then we come together and discuss our respective decisions.

In discussions, both within Canada and the U.S., we've been clear that not one of us can abrogate to the other the responsibility of making a decision. A very clear example for us in the Canadian context is that we have to look at things such as our Species at Risk Act, and in the United States they have to look at their Endangered Species Act. We know that at times there will be some differences, but the intent is to minimize any differences that are under our control and to maximum the harmonization across the two.

Going forward, we hope that will address the fact and reduce the increase in this technology gap. The problem is that the history shows that Canada didn't approve as many products, mostly because industry wasn't bringing them to us for those uses, and this is where we think this kind of pilot project will have some pay-offs.

I'd ask my colleague Richard to make some comments on that.

[Wayne Easter, Liberal, Malpeque, PE]

While Mr. Aucoin is commenting as well, will this do anything for the backlog of products? Because I think at one time it was estimated it would take 12 to 18 years to get rid of the backlog. Will this process also get rid of the backlog and get us up to even speed?

[Karen Dodds]

In terms of a backlog of submissions, it's actually been addressed and we can provide a graphic to you about that. But I think it was probably by 2001 that the backlog had been addressed. Our timelines now for receipt of a submission and through to decision are very comparable. Indeed, before the U.S. had their PRIA, we were better than the U.S. Addressing the backlog was a huge challenge that the agency faced in the late 1990s, but we don't have a backlog right now.

[Richard Aucoin]

With respect to the technology gap, and I think that's of very much interest to you, we're really taking two approaches. We do have a bit of a retrospective approach. We do recognize that there's some significant catch-up to do in terms of the kinds of registration approvals available in the United States versus Canada, particularly in the area of minor uses, particularly for the horticultural uses. So this pilot program that we've been talking about is heavily focused on trying to encourage submission to Canada of those active ingredients that hold a huge minor use potential, a huge promise for additional minor uses for Canadian growers.

We've been trying to identify, with help from the Canadian Horticultural Council and others, what exactly the priority chemicals are that we need to encourage to come to Canada. We're going to, in a way that we've tried to do in the past, largely base our evaluations using the U.S. EPA data packages. All the data and information that was submitted to the EPA will be provided to Canada. We will base our decisions largely on that information when we can.

I and others have often described the situation of Canada with the United States in a way that says we're substantially harmonized when it comes to the agricultural chemical requirements for registration. I think I've occasionally got into trouble for using that adverb “substantially”, because then people want to know what I mean by “substantially”.

Over the last number of years we got to a point right now where the kind of information that we need to make our decisions in Canada is so close to the U.S. information package that this will be a real test of our ability to use those U.S. EPA packages, and what specifically, in addition, do we actually need for Canada? We've narrowed that down to a point where it really is hopefully just at that point where, as Karen says, there are certain areas, like endangered species, where we may have to have specific information, but we're really hopeful that we can move ahead with the U.S. EPA data package. So we're really putting a lot of our eggs in the basket of this pilot program over the next year.

Prospectively, looking ahead, we're also very active in promoting and encouraging joint reviews, not just Canada and the United States, but globally. As Karen mentioned, we have global reviews, in-house, coming into PMRA this summer that are going to be...Canada, the U.S., and Australia. We have one in-house now, and we have another one coming in June. In September we'll be working on a joint review with Canada, the United States, and Austria on behalf of the European Union. In January of next year, the first truly global review will come in, which is Canada, U.S., Europe, Australia, New Zealand, Hungary, Italy. It's very global, so we're really encouraging that as a way of moving ahead and trying to encourage those minor uses to come into Canada at the same time as those other countries.

[Karen Dodds]

Perhaps I may just elaborate a bit. This is a new approach for PMRA, and I would be interested in any comments that members have on it. In this past year, and looking at the situation for the agriculture sector, and specifically the technology gap, and knowing that the gap exists mostly for newer products that are safer for humans at large and safer for the environment at large, the conclusion I came to, and it was supported by colleagues in the agency, was that it was worth putting our resources up front into our doing this kind of analysis. We're the ones who have asked the EPA for their reviews. We're the ones who, before our registrant has come to us, are looking at it and saying, do we think this poses any problems, or do we think it really is simply a kind of formality?

The growers we've discussed it with say they think it's a good approach, but it is a different use of public moneys. I think it's been justified, given the technology gap, given that these are newer products. These are for minor uses, which the industry typically doesn't find to its financial advantage for them to do all of the work. It also is in a collaboration with Agriculture's Pest Management Centre, where, if we need some research work, again, there's the opportunity to look at that. So it really is an investment of public funds in trying to achieve some reduction in a significant way on that technology gap. We're clear we're looking for newer products, where we can say they're safer for human health and they're safer for the environment. So from my perspective, it's a win across all sides.

[The Chair, Conservative, Gerry Ritz]

Thank you.

Madame DeBellefeuille.

[Claude DeBellefeuille, Bloc, Beauharnois—Salaberry, QC]

Thank you very much for your statement.

In order to understand your work, I will use a very concrete example. There is in my riding a producer of miniature lettuce who exports 90% of his production to the US in summer. In winter, he produces in Florida. Here is how he explained the issue to me. Since we don't have the same standards or products as in the US, we don't have the same regulations or standards and it was very difficult for him to bring back to Canada 4 or 5% of his Florida production. Do you think that the work you have done about the technological gap will allow this producer to export and import his lettuce more easily? I would like to understand the practical effect of what you have explained in your statement.

[Karen Dodds]

There are two aspects to what we do about harmonization. First, there is the issue of product registration, and there is the issue of Maximum Residue Limits.

Both of those can present challenges to producers, to exporters, and to importers. All of our work focuses on both, and we're clear with our colleagues in the U.S. that the best world for us is not just one in which we have the same pesticides approved, but one in which we have, as much as possible, the same MRLs

for pest control products in both countries.

At times, because of the different climatic conditions or agricultural conditions, they may need pesticides in the United States that we do not need. In southern Florida, the pest pressures may be quite different from what they are in Canada. In that situation, the Americans or Canadians can ask that we establish what's called an “import MRL”.

What we've been doing again with our revocation of the 0.1 parts per million MRL is to try to make sure, if it's a product that our farmers could use and would like to use, that we're not establishing just an import MRL, but that we're actually working to give our farmers access to the product. But we will still continue to see some instances in which there will be just an import MRL.

[Claude DeBellefeuille, Bloc, Beauharnois—Salaberry, QC]

In the case of minor use -- I'm not talking about major grain production but about vegetables -- would it not be possible to set up joint reviews? Producers tell me that the tests are different in the US and Canada. However, some producers operate in both countries and they find it difficult to and costly to have to go through different tests for new products. You talked about joint reviews and I would like to know if both countries look jointly at different aspects? Is there a common review process with the same tests in both countries?

[Karen Dodds]

There are still a few areas for which we require information about the Canadian situation. One of them is the case of the residue trials. Residues left from a product used in a field in Quebec might be quite different from those left if the product were used in a field in Florida. We want to try to have the appropriate residue.

Now, this has been recognized as a challenge not just between Canada and the U.S., but more broadly. So there are efforts under way to see what, if anything, can be done about that, to both respect what are called “good agricultural practices”, which will differ, depending upon the area, the climate, etc., and the relation between these good agricultural practices and the maximum residue limits. But we are very aware, especially for minor uses, that it is this testing that's needed that raises costs.

This project tries to make sure that we're looking at finding the minimum that would be needed, or determining whether any is needed at all in the Canadian situation. We're also looking at other approaches to addressing that situation. We're working with the U.S. on crop groupings, and potentially what are called “super-crop groupings”. So again, if within this group of crops you've done tests on two, you'll get an approval for all 15 crop types, as an example.

It remains a challenge, but it's a challenge we're working on.

[Claude DeBellefeuille, Bloc, Beauharnois—Salaberry, QC]

Organic farming is expanding at a rapid pace. It is very trendy in California where many products come from organic farming. We've heard recently that even big stores like Wal-Mart want to introduce organic products, and more and more consumers are asking for them. Is PMRA working proactively to make sure that our farmers have access to the tools they need to practice organic farming?

[Karen Dodds]

There are huge challenges in organic farming. For example, Richard went to the US last month to meet with representatives of their organic pesticides sector. He has also met with the people from Agriculture and Agri-Food Canada.

the Pest Management Centre, over the past year. They've been developing more of a focus on bio-pesticides, the biologics, recognizing that the pesticide sector is very small, and the grower sector is small, growing, and has challenges.

[The Chair, Conservative, Gerry Ritz]

Mr. Bezan is next, for seven minutes.

[James Bezan, Conservative, Selkirk—Interlake, MB]

Thank you, Mr. Chair.

Thanks for the presentation. I was listening to some of the answers you were giving, and you told Mr. Easter that there was no backlog currently at PMRA. In the past at this committee we heard that a number of registrations were held up, in the chute, not getting looked at, and some of them had been there for a number years.

I'm just wondering how we got rid of the backlog. Did they get approved, did they get rejected, or did the companies withdraw them because it was just taking too long to get the approvals?

[Karen Dodds]

That was before my time, so I will ask Richard if he has more information than I do.

I know we have a graphic. My colleague has a few copies, so maybe he can give the clerk a copy. We'll provide it later in both languages with an explanation.

It looks at time and registration timelines from the date of receipt to the decision, and it is very clear to somebody who didn't come into the world of pesticides until 2005 that there really were problems in the 1990s. There is one product that took over 20 years from receipt of the submission to the registration decision. I believe the year break will be at sort of 2001 or 2002. There were still a number that were actually above 10 years--10, 11, 12--and a few up around 14 years.

With the management of submission policy and receipt of new resources in late 2002, the PMRA really did put attention to addressing the backlog. Again, part of the reason for the creation of the agency and the focus was to address that. This shows that the backlog was addressed by 2000.

[James Bezan, Conservative, Selkirk—Interlake, MB]

I appreciate the data you've tabled today, but when these data are presented to committee I wish they would include more of an historic perspective. How many product registrations were applied for over the timeframe? I think you're talking about length of time to be received. How does that get final approval? How does that compare to other jurisdictions around the world, not just the United States and our NAFTA partners?

You mentioned in your presentation that we have to be globally competitive. This is an issue that I keep hearing about from our farmers across the country--that we have to be able to address where we stand. I think it's a breath of fresh air that you recognize that, Karen. You said it in your presentation. I don't think we've necessarily had that in the past in presentations by your predecessors.

One of the things farmers have been getting around is the cost differential that exists, especially in glyphosates and some of the other farm products out there. They've been using own-use import permits under that program. There was talk that it was going to be restricted. Do you have an update for us on what is going to be happening with that program?

[Karen Dodds]

It's the task force I referred to that's been examining the issues and coming to a consensus on making recommendations. I do think that the report will be coming out very shortly.

As I understand it, the consensus is that the program should continue, but with some changes addressing the issues raised, so that there still would be access to products outside of registration. From a regulator's point of view, we know we've addressed our responsibility for ensuring that there aren't problems for human health and the environment.

Regarding the evolution, I don't have the details, which will be in the report, but as I understand it, everybody is clear that some form of this program should and will continue. We have continued the own-use import program for this year, 2006. We made some minor adjustments to the requirements for the permit and so on, to help address the situation with container disposal. The intent is to have a migration from the current to the future program, in a way that has the least perturbation upon the system.

[James Bezan, Conservative, Selkirk—Interlake, MB]

You said that the approval time has been fairly quick compared to the U.S. What type of timeframe are we looking at, on average, for products to get approved or rejected, to make those decisions?

[Karen Dodds]

I can ask my colleague Richard Aucoin to talk about comparability, in terms of the numbers of actives and new uses, and of the timelines with the United States and others, because he's much more familiar with the international environment than I am.