Good morning. I appreciate the opportunity to appear before you today to provide an update on our activities at Health Canada's Pest Management Regulatory Agency.
[Translation]
As requested by the Standing Committee, I have submitted a report that indicates the number of new and minor use pesticides approved, the number or older pesticides that have been re-evaluated, and the number of temporary and emergency registrations granted. The report also expands on a number of our initiatives, including our activities related to closing the technology gap. I or Richard Aucoin, the Chief Registrar, would be pleased to answer questions on this material after my presentation.
I would like to take this opportunity to highlight some of our work and achievements that we believe will be of benefit to Canadian growers.
[English]
As you know, shortly after my last appearance before this committee, the new Pest Control Products Act and the revised pest control products regulations came into force. I am pleased today to be able to announce that two new regulations under the new act, the pest control products incident reporting regulations and the pest control products sales information reporting regulations, have both been registered and were published in the Canada Gazette, part II, on Wednesday, November 15.
The incident reporting regulations require registrants to report incidents, including adverse health effects, related to the use of their pesticides. The information collected from pesticide companies will be combined with voluntary reports received by Health Canada in an incident reporting database.
[Translation]
The Sales Reporting Regulations require registrants and applicants of pesticides to report information related to the sales of their products. These Regulations also allow as to require sales date upon demand in response to a situation that endangers human health or the environment. The Incident and Sales reports will enable us to monitor adverse impacts and provide us with greater information to assess the health and environmental risks of pesticides when conducting our evaluations.
[English]
Over the course of the 2006 growing season, the own use import program was again used extensively by Canadian farmers. By the end of June, we had approved 2,301 permits to allow the importation of 4.64 million litres. In the fall, we approved an additional 1,035 permits, bringing the total volume imported to 6.4 million litres.
Because the product label prohibits the use of ClearOut 41 Plus for weed control following a killing frost, we set timelines for permit applications, which considered the time needed to review the applications and import the product and which forecasted the expected timing of a killing frost.
Consistent with our approach last year, we consulted with our provincial agricultural specialists to forecast approximate final dates of use of ClearOut 41 Plus on a province-by-province basis. The earliest date forecast was October 15, in the prairie provinces. Unfortunately, we had to stop issuing import permits for the prairie provinces on October 11, as a killing frost had occurred throughout the region by that day.
In our work with registrants, growers, other government departments, non-governmental organizations, and the general public, we know that effective communication is key to enhancing understanding, confidence, and input into our work. Stakeholder engagement, for us, is essential to understanding the needs of the agricultural sector.
We have been communicating with our stakeholders, making regional visits, and working with organizations such as the Canadian Horticultural Council on a number of initiatives that I have outlined more fully in my report. Included in this list of activities is, as you know, the own use import program and the own use import task force that we established in 2005.
The own use import task force reached a full consensus and submitted its reports and recommendations, which were publicly released in July. The task force's recommendations are aimed at providing greater access to competitively priced products for growers while protecting manufacturers' investments in the data used to support the registration of their pesticide products.
We agree with the task force report and have initiated new work, including the pilot of the grower requested own use program, or GROU program. The GROU program, as described in the report, would be driven by the priorities of agricultural producers and would result in the availability of a wider array of pesticides for the benefit of many different users.
We have assessed 13 candidates to determine if the U.S.-registered products are materially identical to the Canadian-registered product. This pilot project has principally served as a basis to develop and refine both the scientific and administrative approach to the review of future candidates.
[Translation]
Disposal of containers imported under the Own-Use Import Program was highlighted by the Task Force as a pivotal issue. PMRA has significant concerns with the progress made to date on OUI container disposal. The GROU Program recommendation also stressed this issue, in particular, the need to ensure that standards were equal to the current stewardship programs for registered pesticides in Canada.
[English]
Following up on another recommendation of the own use import task force, we've established and have published a proposed “protection of intellectual property” policy. This proposal is an update to the current requirements. It incorporates the principle of chemical or biological equivalency and specifies categories of protected data and the duration of data protection. The new proposal places the onus of determining data value and compensation on the companies involved. The proposal is intended to encourage the introduction of new generic pesticides while protecting the intellectual property of registrants. The proposal extends the period of protection for the addition of minor uses as well, to encourage the availability of modern, innovative, potentially lower-risk products to Canadian users.
We've initiated work on another price discipline mechanism under the North America Free Trade Agreement, or NAFTA. The NAFTA label project allows growers from both sides of the border to access pesticide products that carry a NAFTA label. The product would be registered in both Canada and the United States and could be purchased in either country. As the registered uses of the product may differ between Canada and the United States, the product would carry two sub-labels, specific to each country's accepted uses.
We will be evaluating progress and implementing the recommendations of the own use import task force beginning tomorrow, with participation from the Canadian Horticultural Council, Grain Growers of Canada, Pulse Canada, the Canadian Canola Growers Association, the Canadian Federation of Agriculture, Farmers of North America, Agriculture and Agri-Food Canada, representatives from provincial government, and the pesticide industry. The evaluation will include an examination of the potential benefits of the grow program, relative to the own use import program.
[Translation]
It will also include developments related to the current OUI program, such as container disposal concerns.
[English]
No final decision has been made yet on the own use import or grow programs other than a commitment by us that an own use import program, in some form, will be available to farmers in 2007.
A number of additional projects are under way to further address concerns raised by Canadian growers. Included in these are: revisions to our minor use products to include products in addition to just active ingredients; joint review and work share activities, which have resulted in 76 registrations as of early November this year; nine more joint reviews that are currently under way; work shares; and a project to harmonize maximum residue limit-setting methodology. We've implemented and have worked further on harmonizing subzones for residue data, and we have under way a project to look at active ingredients of strong minor use interest, relying substantially on the United States Environmental Protection Agency's data packages and reviews.
I'm also pleased to announce that we are making progress toward addressing the still significant technology gap between Canada and the United States. As it pertains to our work, we use the phrase “technology gap” to refer to the pesticide active ingredients in uses that are registered in the United States and are of substantial interest to growers, including minor crop growers in Canada, but have not yet been registered here. This is largely because the pesticide manufacturers have not sought registration in Canada due to the comparatively small market for their products here.
To address this gap, one of the initiatives currently under way involves the use of dedicated PMRA resources. This initiative looks at active ingredients of strong minor use interest before a registrant even makes his submission to register in Canada. We're piloting this project for three new active ingredients, selected based on input from growers such as the Canadian Horticultural Council. To meet the approximately four-month review timeline we established, the PMRA is making use of the U.S. EPA's data package and reviews for these same active ingredients. We expect a target date later in December.
[Translation]
The three active ingredients include two conventional chemicals and a reduced-risk biopesticide. If all three active ingredients are approved for use, growers will have access to new pest management tools that would provide up to 250 minor uses to Canadian growers.
[English]
These three active materials will include among them, if approved, about 250 minor uses for Canadian growers.
The success of this initiative relies largely on manufacturers submitting an application to register in Canada. As manufacturers have already begun taking a more global approach to submissions, we anticipate that the situation will improve greatly in the coming years.
I would like to be clear. We are addressing issues of risks to health and the environment while at the same time working to address the concerns of Canadian agriculture. The mandate for our work is clearly laid out in the new act. This stresses that in administering the act, the minister's primary objective is to prevent unacceptable risk to people and the environment from the use of pest control products. But at this time, it's to all of our advantage to get access to newer, reduced risk products, and to have them used in ways that are appropriate for the Canadian agricultural sector.
In conclusion, I hope the projects we have under way will help to ensure that our growers have access to the necessary tools to remain competitive in the increasingly global agricultural market.
Thank you for having me here today. I welcome your questions on any of the issues of interest.
:
There are a couple of different points.
When the own use import experience started with the 2005 growing season, and a number of different concerns were raised, one of the points we made was that it involves the regulator in a different way from a registered Canadian program.
The regulations are very clear about the role the regulator plays. They're clear that it is for import in use in one growing season, and that is a limiter, as compared to access to Canadian registered product.
As a regulator, I have to play by the rules too. With all of the issues raised by own use import from the get-go, we said we are going to try to make sure that everybody plays by the rules, as currently established, recognizing that all sorts of parties have different issues with own use imports.
So the idea is, yes, we continue with it. We recognize that some folks really like it; some folks really don't like it. There are different issues. So we will continue with the rules, as in place now, with a task force established that made recommendations. As I said, part of it is an evaluation starting tomorrow.
So, yes, if a farmer bought Canadian-registered glyphosate in a co-op down the road, the farmer gets to use it under the farmer's own judgment. With own use import, we're clearly having to play a role in approving an import permit. That's part of our job, and part of our job as a regulator cannot then be to make a farmer non-compliant with the label.
This is a difficult issue. I'm not saying we like it. It's part of the current rules. Whether that continues under the grow program, some of those details have not yet been established.
:
My apologies for being late, but I knew this would happen this morning.
At the outset I'll say welcome. It's almost a breath of fresh air to see some progress being made at PMRA after so many years of what we felt was less than adequate performance. And that perhaps is an unfair judgment of PMRA, but I think we've moved beyond a certain point, which is the reason for our requiring you to come twice a year. So we want to thank you for coming this morning.
I missed out on some of the questions, so I hope my questions will not be repeats of what has been asked before.
Manufacturers, obviously, are looking for the greatest share of the market they can find, and obviously introducing a product into numerous countries at a particular time is important. My understanding is that PMRA has entered into new joint agreements, “review initiatives”, if you want to use that term, with the United States, Australia, and one with Austria. Obviously, there are things that we would find as common between all of these countries. If we were to look at issues that can be deemed to be common.... Let's basically look at the United States, because they're our neighbours and we commonly talk about harmonization, and if there's harmonization with the Americans, we really don't care about what happens with Australia, particularly. But if we could harmonize with the United States, we would feel we've made some progress.
What would be some common areas where you would be able to check that one off and say that one is now behind us, it is not an area where we have to do further study or further science? What are those issues that we would consider as common points where we can agree we'd go forward on? If it works in Michigan, it works in Ontario. We know the geography, the land type, and the soil type and those kinds of things. What are the really common things that we can take off the table?
:
Yes. There are a few things we're doing about that.
One is that our re-evaluation program now holds regular teleconferences, and anybody who's interested can participate. A number of grower groups have people participating. That is to get a better sense early of whether, if you cannot have this product anymore, it presents you with concerns. So it's to get a better understanding of where a product is being used now, where it's a critical product, so that we can see what we can do to set up.
We are specifically looking at transition strategies. We are minimizing the number of times we're taking away one tool without having another tool available. That's one thing we're doing.
At last week's NAFTA meeting we pursued further and have agreed with the United States Environmental Protection Agency to work in close collaboration, if not work share, in our future work on re-evaluation and their future work on registration review. So again, it's to recognize that what's good for new products is also good for old products. As we've said, the scientific assessment is very consistent, and one of the ways of addressing workplace pressure is to work more collaboratively with fellow regulators.
That brings with it its own pressures. Richard and a couple of other colleagues were in Bonn, Germany, to work out the scheduling details of the joint review. I need to be able to say it's worthwhile for Richard to travel to Bonn, that it isn't a tourist trip, that he's actually doing good work there.
We're also working in collaboration with the United States in developing a future timeline for re-evaluation activities.
With our Pest Management Advisory Council, we've also talked about our ability within PMRA to prioritize work. Again, the system had been to respond primarily to what registrants were bringing to us, first in, first out. Registrants are most likely driven by their bottom line, which is profit, which I don't agree should be our bottom line. I am more interested in what's happening in the Canadian environment. We're public servants. I'm interested in, as I say, giving access to newer products to all users, not just the agriculture sector.
We have talked about prioritizing and saying that if a new product is going to be a critical replacement for an old product, it will move into an earlier position in the queue and we'll address it faster.
Again, an example that I give when I'm talking with stakeholders is if it's the tenth herbicide for corn, is it as important as if it's the first for wireworm in potatoes? I think most people would agree that the latter situation, the first product to work on wireworm in potatoes, is more important for us to work on than the tenth herbicide for corn.
Again, our Pest Management Advisory Council saw merit in that and supported us going forward with it.
:
Again, I don't know whether Richard has more details, but we did check with our people on whether this specific product would work after a killing frost and they said no.
Not all glyphosates are the same. They have different formulas, different adjuvants, and different safeners. The information we got was that this product does not work, which is why it's on the label like that. To use a product inconsistently with the label is not in compliance with the Pest Control Products Act and regulations.
The other thing I want to say is that at the NAFTA meeting last week, as an example, we did not have environmental groups represented. We did not have health NGOs represented. The discussion at the Pest Management Advisory Council is that right now those groups are fairly satisfied with where we are as a pesticide regulator and where we want to go. They aren't concerned about the own use import program.
Our provincial colleagues raised the container disposal problem with us. In terms of us taking it forward, we are trying to make sure we are keeping environmental groups and health groups as satisfied as critical user groups, which obviously include agriculture, when it comes to what we're doing as a pesticide regulator. That's not an easy job of balancing.
Right now we're at a point where, quite literally, we've had some of the environmental groups say, “We are satisfied and we may actually not continue on your Pest Management Advisory Council because we have other fish to fry, other issues that are now of a higher priority.” With the own use import program, they've been very carefully watching what is happening and how Health Canada is enforcing, because they recognize that this is product that isn't registered in Canada but is brought in under other things.
In dealing with the own use import, we're also thinking of what the provinces are raising to us as concerns and what the health and the environmental groups are raising to us as concerns. They were invited to be part of the own use import task force, and both the health and the environmental groups elected to see all the documents and raise issues just in a paper review. Again, they've maintained enough satisfaction and confidence that they haven't been active participants. They've just been watching all of the written information, which we've been continuing to share with them, as with everybody, in regard to what's going on with that program.
:
Good afternoon, Dr. Dodds and Mr. Aucoin. Thank you very much for being here.
Dr. Dodds, you said the goal of the PMRA is to minimize the number of times we take away one tool without another tool being available. That's exactly what the PMRA has done with the 2% liquid strychnine, which is the only effective control for Richardson's ground squirrels or gophers.
Furthermore, it's shocking to find out that there was no evaluation of the dollar value of losses to crops that farmers have suffered due to having this product taken away. I have heard estimates of $200 million a year. From what's been happening in the last couple of years, I believe that would be low. It's a huge issue for farmers. The number of letters I get, and no doubt the number of letters you get, from farmers and people from municipalities would back that up.
This product was removed some time ago. In 1998 I put a motion before the House for the production of papers. The motion read:
That an Order of the House do issue for copies of all documents, reports, minutes of meetings, notes, memos and correspondence regarding all aspects of the government's ban of the 2% and 5% solutions of strychnine.
That motion passed. It was sent to the PMRA, and I received a roughly 200-page document that is supposed to include all of those papers. Going through those papers, it was shocking that there was no information in there that should have led to the 2% strychnine being taken from farmers and this great cost being imposed on farmers.
Furthermore, in 2005 the PMRA did a couple of reports on strychnine. One was on the re-evaluation of strychnine and its proposed acceptability for continuing registration. I went through those reports, and there was no good reason for this product to be taken away. I found it quite shocking.
Where is this issue now? Will the 2% liquid solution, which was so successfully used by farmers for such a long time, be returned to farmers in the near future, at least on a pilot project, so it can be returned fully as time goes on? If not, where is the appropriate replacement product?
:
I would like to go back to the GROU program. Farmers--in Ontario just last week and I know in my part of the world as well--are really concerned that they have an effective own use import, or OUI, program in place. The farmers want it and they're calling for it. I think the new GROU program has some things in it that need to be addressed before it replaces OUI, and I'd like your comments on some of this.
On this proposal that things need to be materially identical, we're getting some concerns from producers and others that it does a number of things, including limit the scope of products registered to the same company on both sides of the border. I'd like you to comment on this, that the product needs to be registered on both sides of the border in order for it to be available.
There is a concern about the ease with which companies can alter the distribution within the U.S., to avoid sending the chemical here, by not making it available down there.
There is a concern about the fact that companies will be allowed to change the product in a minor way to avoid the program, so that it's not materially identical.
There is an issue about how easy it is for companies to change the labels so that the product does not meet requirements and then obviously can't be imported into Canada.
There is also a concern about companies manipulating to extend patent protection on products. That's something that happens fairly often now. They can use other processes or formulations of the product, extend the patent protection on it, and then it doesn't become a generic.
I guess the worry is that the pilot program is really just an attempt to eliminate the OUI program in the short term: we'll give you this dozen or twenty chemicals fairly quickly, but our real intent is to eliminate the OUI program.
Another comment is that if the generic is registered in Canada, Canadian producers can access it from the U.S., but if there is no generic register there, are we out of luck? For chemicals registered in both places, we can access it, but if it's not registered in the United States, what happens? Can we access it or not?
Another comment was that GROU succeeds where there is access, but it is not going to succeed in establishing access.
I'd like your comments.
First of all, in regard to the own use import and the GROU, I think the only acceptable way to proceed from now is to leave the own use imports program in place, introduce the GROU, and let farmers evaluate the effectiveness of the programs. The way I see it, I would guess that two-thirds to three-quarters of the value would be lost under the GROU--the value to farmers, the benefit to farmers--and that's simply not acceptable. That's the way I would certainly like to see it proceed.
In terms of the 2% strychnine, there have been again more statements made that simply aren't verified and backed up by the studies done. In terms of environmental concerns, there are concerns expressed, but there's nothing in any study that would indicate that they're valid concerns.
That's part of the reason that farmers are so upset by losing this product. There is no acceptable replacement. None of the pre-mixes work effectively. Just talk to farmers. They've been widely used. None of them work effectively. The only effective control for Richardson's ground squirrels, gophers, is the 2% solution of strychnine, or a higher percentage, mixed with grain so it can be used fresh. It has to be used within a very few hours of the time it's mixed, certainly less than a day. It becomes stale and the gophers just don't want to eat it beyond that time.
In terms of police forces, if there was some concern expressed by the police, it was not given to me in these documents that I received upon order of the House of Commons. That is of great concern to me. The only RCMP issue that was expressed was a study that was done when the PMRA or some former body asked some RCMP officers to check into the stores to see if the storage in the area was acceptable. So they went to the merchants who were selling this.
Some talked of poisoning dogs. Well, guess what? Dogs are being poisoned now with ethylene glycol, common antifreeze used in cars. Are you going to take that away? Why isn't that gone? That should be taken away, clearly, under the same logic. It's against the law to poison a neighbour's dog, so deal with that problem.
Don't deny farmers a product that can save them millions and millions of dollars every year. Deal with the problem. That's the same logic that led to the gun registry and denied duck hunters and farmers appropriate access to firearms. It's not acceptable logic.
Again, I'd like an answer to my question as to where you're going from here. Where is the PMRA going from here in terms of the availability of strychnine for farmers?