Evidence of meeting #33 for Agriculture and Agri-Food in the 39th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was product.
A recording is available from Parliament.
Conservative
The Chair Conservative Gerry Ritz
I'll call this meeting to order. We're running a little bit late due to a concurrence motion in the House this morning. Thank you for your patience, Dr. Dodds and Mr. Aucoin.
We have five members at the table. That allows us to hear from witnesses. We will proceed. I'm sure other MPs will filter in as the day goes along.
So if you folks would care to lead off....
Dr. Dodds, I see you have a speech for us.
Dr. Karen Dodds Executive Director, Pest Management Regulatory Agency
Sure. Thank you.
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.
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.
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.
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.
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.
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.
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.
It will also include developments related to the current OUI program, such as container disposal concerns.
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.
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.
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.
Conservative
Conservative
The Chair Conservative Gerry Ritz
All right. We'll open up our questioning round.
Dr. Bennett, you have seven minutes.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
Thanks very much.
With the new act, if this were to come into force, what would be the competing calls upon resources? Do you need more money to do this properly? How are we going to make sure that what Canadians hope from us, in terms of measuring the health of Canadians and actually doing what your agency is supposed to do, actually comes in line with population health and the risks that Canadians are worried about?
Executive Director, Pest Management Regulatory Agency
We did get some resources for implementing the new act, which started in 2003. I don't know that there was, at that time, a real recognition of the technology gap and the kinds of pressures upon us to look not just at what the registrants bring, but to also look in a more proactive sense at minor usage. There were funds. That's where we got funds to work with Agriculture Canada's Pest Management Centre, to start addressing the minor use issue in a proactive way. But projects such as the one I described, in which we're proactively looking at three active materials, are a brand new approach to looking at what the best use of our resources is in order to get the most minor uses approved.
The transparency requirements of the new act have made a big impact. Under the new act, when we receive a submission, we have to make that information public. When we propose a decision, we have to make that information public. When we finalize a decision, we have to make that information public. We got some resources, but they were again based on the numbers that were expected in the early 2000s.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
As you know, I've always been concerned about the science. Even in toxicity, the science is quite often based on rats, and rats spend their lives detoxifying themselves in toxic environments. That's what they do. The link between human health and a rodent is pretty good at what it does, but sometimes it hasn't actually made the leap for me.
If it were a drug, we would be interested in doing a better job on post-market surveillance. What capacity do you have or do you think we should have for following up, say, the concern in P.E.I. at the moment around what seems to be a cluster of disease around certain chemicals being used?
Executive Director, Pest Management Regulatory Agency
The new act does give us strengthened post-registration controls. Part of that is realized with the two sets of regulations I mentioned. One is the incident reporting, which includes adverse affects. Once that's implemented--I believe it's in force on January 1, 2007, so the beginning of the new year--it will be mandatory for registrants to report to us all incident reports received, including adverse affects. That includes transmitting to us information received in the U.S. as well.
The new act requires that we undertake a re-evaluation of all of the older pesticides every 15 years. We had already begun that, by policy, in advance of implementation of the new act.
It also gives us some new tools so that we can now demand of registrants information at the outset of a re-evaluation rather than waiting for them to decide that they want to submit information to us.
As well, as part of the management of chemicals action plan, there is some money for biomonitoring. Information collected, starting this fall, done by Statistics Canada and funded by the government, includes some biomonitoring of analytes, which can indicate exposure to pesticides.
So we are very interested in improving our understanding of what is happening in the environment after products have been registered. For the first time, we've had the position of an epidemiologist established within PMRA. We've already started the work of recruiting an epidemiologist to look at the human data we have as well as all the toxicological studies that the registrants have to submit.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
In the setting up of the new cancer agency, at its inception will you have an ongoing relationship with them in terms of population health and in terms of the primary prevention that I think we all want? Because individual by individual, I guess, I've never been able to see that we can prove...you know, things that are not proven to be dangerous aren't necessarily safe. So this is a different standard.
From chimney sweeps and testicular cancer to the aniline dye industry and bladder cancer to asbestos and mesothelioma, what capacity do you have to make those links in terms of human health and the things you're approving?
Executive Director, Pest Management Regulatory Agency
We work in a few ways. With cancer statistics, we're obviously very interested in receiving information, but we're also interested in improving the collection of exposure to the risk factors that led to the development of the cancer statistics in the first place.
This fall we had in a group representing the Ontario College of Family Physicians, including the CEO and including the primary author of the report they published a number of years ago, in order to meet with them and go over in detail how it is we approach our evaluation of the health impact, to share with them, to hear their concerns, to hear about the survey they use with patients when they have concerns about exposure from the environment impacting on health. We want to have a dialogue about what are the best indicators. They also provide some comments on the forms we're using for the incident reporting.
So it's looking at working with both family physicians and others involved in the health care system, working to get the best information out to people who need to be concerned about how they're using pesticides, and then putting back into the system what are the impacts.
Liberal
Carolyn Bennett Liberal St. Paul's, ON
Is there a capacity to have a longitudinal survey of the health of farmers?
Executive Director, Pest Management Regulatory Agency
There is one in the United States. We watch that and monitor it very closely. I'm not sure how often they publish their report, but it is a very large, very comprehensive study of farmers and their families.
Conservative
The Chair Conservative Gerry Ritz
Thank you, Dr. Bennett.
We'll move to Monsieur Roy for seven minutes, please.
Bloc
Jean-Yves Roy Bloc Haute-Gaspésie—La Mitis—Matane—Matapédia, QC
Thank you, Mr. Chair.
When you drew a comparison between Canadian and U.S. agriculture, you said that Canada should make every effort to be at the same level as the Americans with regard to the use of new pesticides.
According to your assessment, are the Americans really ahead of us at the moment in terms of the registration of this type of products? And can we really rely on U.S. registration compared to ours? Basically, my question is as follows: is ours more stringent than the Americans’? Is the registration process quicker in the U.S. or in Canada?
Executive Director, Pest Management Regulatory Agency
We have statistics from the last few years that show roughly half of the new actives we've reviewed have been done jointly with the United States. That is better than the experience from ten years before. So joint reviews are improving access at the same time to both Canada and the United States. Indeed, there's a consensus that the number of joint reviews will increase.
In doing that, we're clear that we have the authority to make our decisions and the Americans have the authority to make their decisions. We are doing the scientific review work in partnership, so some of my staff in PMRA will do certain parts of the evaluation, the U.S. staff will do certain parts of the evaluation, and then notes will be compared. The experience has been that when we do that we make the same decision at the same time.
We also know that in the United States, the IR-4 program is responsible for the majority of submissions for minor uses in the United States compared to Canada. Agriculture Canada is working with IR-4 now, but we're working to try to bring as many of those submissions for minor uses to Canada that are appropriate to Canada.
On the nature of our scientific reviews, the easiest area to explain the difference is the environment. Our act says we have to consider other Canadian laws and policies. So we have to consider the impact of the Species At Risk Act, whereas our colleagues in the U.S. EPA need to consider the Endangered Species Act.
Quite clearly, there are situations in regions where you're going to have different elements of the ecosystem at risk in Canada versus the United States, and it may lead to differences in decisions. But it will likely be at a specific level rather than at a broad, enabling level.
Bloc
Jean-Yves Roy Bloc Haute-Gaspésie—La Mitis—Matane—Matapédia, QC
So this could lead to different decisions. As a matter of fact, products that are registered in the U.S. cannot enter our country because our Canadian Environmental Assessment Act, which is linked with the Endangered Species Act, prevents us from allowing these products in before conducting studies on species that could be at risk. This is more or less what you are telling me.
I have other questions. One of the main problems linked to the use of pesticides by farmers is their improper use. I would like to know how pesticide users are trained.
More often than not, the products’ dosage is inadequate and only approximate. Is any training offered to this effect? Are provincial authorities providing training to farmers who use pesticides? How is this training monitored? The bottom line is that the user is as much at risk as the person who will end up consuming the product.
Executive Director, Pest Management Regulatory Agency
Yes. We have adopted various approaches to train the users.
We work with grower organizations. We work with the Ontario College of Family Physicians. The more farmers understand why they should be careful in using pesticides, the more they will take care in using them. The provinces also have a responsibility to ensure that users know how to use the products they are interested in.
Increasingly for us it is a sort of system-wide approach. That's one of the reasons I've spent a lot of time meeting directly with grower organizations. It's not just in the nature of us wanting to tell them what they need to do; it's also so they can tell us what their issues are. If we say to do this and it doesn't make sense to a farmer, they're not going to do it. It takes both parties to work to say, “Here's the issue, and here is a way of using the product that will address the issue and protect the farmer's health or the environment.”
Bloc
Jean-Yves Roy Bloc Haute-Gaspésie—La Mitis—Matane—Matapédia, QC
Mr. Chair, do I have another minute?
Bloc
Jean-Yves Roy Bloc Haute-Gaspésie—La Mitis—Matane—Matapédia, QC
How would you currently assess this training? You are telling me that you are working with the associations and the provinces but you certainly get some feedback on the training being provided. How would you assess this training? Is it good, excellent or not so good? We know that there is always a risk involved.
Executive Director, Pest Management Regulatory Agency
Our real concern is finding out where we could make some improvements.
We have inspection and compliance people. In this kind of arena, I think what you're looking to do is to develop conditions that support compliance rather than have inspectors go out and enforce. Again, I think we need to talk more about how we work with our provinces, grower organizations, and farmers to make sure there is a good understanding of the appropriate ways of using products.
Bloc
Jean-Yves Roy Bloc Haute-Gaspésie—La Mitis—Matane—Matapédia, QC
So your conclusion is that, at the moment, training can be rated as average.
Executive Director, Pest Management Regulatory Agency
Yes, there is room for improvement.