Thank you, Mr. Chair.
I am very pleased to speak to you today to give you additional information about the import program and to update you on the progress achieved with the implementation of the recommendations of the Task Force and on the use of strychnine.
I want to start with the last first. I want to recognize the problems that our growers in western Canada are experiencing due to the high population of gophers, or Richardson's ground squirrels.
Many growers and a number of members of Parliament have been requesting the reinstatement of 2% liquid strychnine as a control tool. We are working with growers and with provincial governments to explore viable solutions to this serious issue.
In 1992 Agriculture Canada, then the regulatory body for pesticides, restricted the availability of the concentrate strychnine for gopher control, in consultation with the provinces. This decision was based on strychnine's high acute toxicity, on the lack of any antidote, and on incident reports showing intentional and unintentional non-target poisonings. A 0.4% ready-to-use bait formulation was registered as an alternative for growers.
In 2003 a fumigant widely used for the control of insects and rodents in stored grain, aluminum phosphide, was then registered for the control of gophers.
Growers in Alberta have used Phostoxin for the control of gophers, with very positive results.
In addition, since 2003 we've been working with colleagues in the provincial governments of Alberta and Saskatchewan, academia, and industry to develop an integrated pest management strategy for the gophers.
Because of grower concerns about the effectiveness of the available alternatives to 2% strychnine, and some concern about how useful Phostoxin is, we've planned a pilot project that incorporates some research objectives for this growing season.
This project will compare the effectiveness and impacts of the latest product, Phostoxin, and both ready-to-use and freshly prepared strychnine bait.
In 2005 we conducted a science-based health and environmental assessment, re-evaluating the remaining uses of strychnine, using current scientific standards to determine whether and under what conditions the 0.4% ready-to-use bait is acceptable. The re-evaluation reconfirmed environmental concerns related to the poisoning of non-target species that were first identified during the scientific evaluation of the liquid concentrate in 1992, and additional protective measures intended to alleviate these concerns were put into place.
We propose to maintain the registration of the 0.4% strychnine as an interim measure until 2008. At that time we will consider the results of this year's proposed research project and the findings of the expert committee before making a final decision on strychnine.
I would now like to turn your attention to the topic of the own-use import program.
Since our last meeting of December, my staff and I have held consultations with many growers in order to understand their concerns and to give them information on the recommendations of the Task Force and on the program itself.
With a colleague, I was in Saskatoon during crop production week, where we met with the boards of directors for the Saskatchewan Pulse Growers Association and the Saskatchewan Flax Development Commission.
The FarmTech show in Edmonton was another opportunity to speak to Alberta Pulse Growers, the Alberta Canola Producers Commission, and the Alberta Barley Commission. And most recently my staff met with the board of the Canadian Canola Growers Association in Winnipeg. We have committed to a number of other engagements in the upcoming weeks and months.
We were well received by all groups and they expressed appreciation for our outreach efforts.
On our part, it was very informative to talk to a broader group of growers about these issues. One consistent message that we heard from all groups was the need to communicate more and provide better information to growers.
We are working with several of these groups now to provide objective information that can be then used in a variety of agricultural publications to try to provide that information.
Another message that was clear was the desire to see the new programs proposed by the task force up and running so that growers could see the benefits for themselves. You will see in my presentation that we have achieved a number of significant milestones in this regard.
However, we have seen that farmers are somewhat reluctant, which is understandable, to abandon a program which has allowed many of them to realize direct savings on their costs. That is why we will continue to work with the producer groups to give them more information on our plans and programs so that they be able to judge them on their merit.
We've also continued to work with the task force. Indeed, a meeting took place the day after our last appearance here. The message from that group is that they're still supportive of the package of recommendations, including the new import program, but consistent with the discussion from the last standing committee, a number of details still need to be worked out. The group is scheduled to reconvene again next week.
Consistent with the recommendations of the task force and with the motion from the standing committee, growers will have access to the current OUI product, ClearOut 41 Plus, for their 2007 needs, as the groups work on transition details and timing. Details related to permit applications for growers are now available on the PMRA website.
I would now like to take a few minutes to present the document distributed to the committee.
I'm not going to go through the slides that you have point by point. I'll just try to take us very quickly through them.
Starting with the slide entitled “Background”, the current own-use program has been in place since 1993 and was intended to be a price discipline mechanism. In the case of the first three products, the program appears to have worked as a price discipline mechanism as intended, and essentially no product crossed the border.
In the 2005 and 2006 growing seasons, with ClearOut 41 Plus, we had a different situation. In each year, there were over 3,000 permits granted, with an importation of approximately 5,000 litres each year.
The next slide gives an overview of the own-use import program. Just note that under this program the sponsor is responsible for showing that the product to be imported is chemically equivalent to a registered Canadian product, and it has to have a Canadian label. The user—in this case always the farmer—must obtain a permit to import the product and must comply with all requirements under Canadian legislation and all of the requirements on the permit.
The import certificate, which is issued by the regulator, includes details including the amount of the product and the location of use, and it's valid for one growing season only. I want to be clear that this program involves the regulator in ways that are different from registered products in Canada.
As you know, and as is detailed on the next slide, we put together a task force to look at the different issues. On that task force, we had grower groups, industry, and federal and provincial government representatives.
The next slide is on pivotal issues. A number of issues were considered to be key, and they're listed here. I'm going to note three that, from the regulator's perspective, are key.
The first one is container disposal. This product is exempt from registration. It is therefore not part of the industry-funded stewardship program, and there were no means to recycle the containers originally. Farmers of North America, who have been the sponsors, subsequently developed a program. However, as of early January, only 29% of containers have been returned through this program to date. This presents a serious concern for federal and provincial governments, as well as some stakeholders.
Our provincial colleagues have noted to us a concern, because much of the provincial legislation only deals with product that is registered at the federal level. They have no means at their disposal to take action on product that is exempted from registration at the federal level.
Under the own-use import program, equivalency allowed variability. Based on the fact and the premise that product wouldn't come into Canada, that it was a price discipline mechanism, there was a fair degree of leniency in terms of determining equivalency.
The task force focused on a package of recommendations that addressed these issues overall, rather than specifically addressing each one of them. The task force report outlines a number of recommendations. One key one is a new program for own-use importations. It was called the grower-requested own-use program, and it would continue to provide growers with access to a price discipline mechanism. There were also a number of additional initiatives that were both to improve access and to address price.
Some of the details in the task force recommendations are on slide 7: that we would do a pilot of the new program in 2006, involving grower groups, the registrants, CropLife, and PMRA; that we would move ahead as fast as we could with recommendations on further regulatory harmonization and intellectual property; and that there would be an evaluation of progress on all recommendations.
The next slide notes some of the further aspects of the recommendations. Consistent again with some of the concerns raised at standing committee, there was a concern about whether or not the package of recommendations is a sufficient and effective substitute for the current program; that eligible grow candidates would be made available once the determination is made; that the package of recommendations is in fact an effective substitute for the current own-use import program.
The next slide focuses on the GROU program. It would allow growers to import the U.S. version of a Canadian-registered product. The registrants have agreed to play an active role here in identifying relevant products in helping with determining the issue about equivalence or identicality. We would determine, as the regulator, identicality and eligibility, and that there is no need for a laboratory analysis.
The next slide on GROU lists some of the anticipated characteristics. Recognizing that under the current own-use import program the ways and means of establishing chemical equivalents are typically very expensive, the GROU program offers a potentially large number of candidate products to be available very quickly.
Because we're doing a comparison of the paper specifications, it needs no equivalency determination to be done by grower groups. Again, the registrants have agreed to participate and look at chemical specifications. It offers the potential for immediate and substantial widespread savings for growers.
It's limited. The task force used the term “materially identical products”. A lot of concern has been raised about that phrase “materially identical” under GROU versus “chemically equivalent” under the own-use import program. Many have concluded that the standard is tougher under GROU and therefore eligible products would be more limited. Indeed, this is not the intent, and it has not been the case with the GROU pilot to date.
As the regulator, we've been clear from the outset that the past standard for chemical equivalence under own-use import is not acceptable. The new wording was to signal a change that the standard is not identical. For example, under the GROU pilot, we have accepted products where there are known differences in formulations, for example, different surfactants, but they don't have an impact on the functionality of the product or its health or environmental profile.
The next slide gives a comparison of the two programs, the GROU and the own-use import. The first notes under GROU show it's limited, at least in this phase, to U.S.-registered products. Under own-use imports, we note it's unlimited. But that's really not the case. You would be very much limited to foreign products that are considered chemically equivalent.
Under GROU, the chemical specifications are the basis of equivalence. That's simple. Under the own-use import, you could use chemical specifications if the grower group could get that from both a Canadian registrant of a Canadian product and the foreign registrant of the foreign-based product. But that's unlikely. They would usually be using an analytical determination, which is difficult and costly. Under both programs the Canadian registrant or indeed the foreign registrant can impact equivalence.
Under the GROU, we've had eight potentially qualified candidates out of thirteen nominated. While they are mostly herbicides, they offer a much wider-use pattern than ClearOut 41 Plus. So it's clear at the outset that farmers will potentially benefit from more than just the ClearOut 41 Plus.
ClearOut 41 Plus was nominated under GROU, but the registrants have not participated, so we haven't seen the chemical specification forms. ClearOut 41 Plus has an equivalency certificate that's valid until the end of June. Both programs require that there be a Canadian registered product.
On the next slide, looking at considerations from the regulator's perspective, there are two that are very problematic. One is container disposal. With Canadian registered product, there's a 70% return rate for registered products in the small-size containers. According to our provinces and information from industry, there's approximately 100% return rate for the totes and drums. We met with FNA in early January, and their figures were a 29% return rate for the own-use import products to date. That is dedicated and focused to FNA members. I've already talked about the issues we have with equivalency determination.
On the next slide, the U.S. has recently developed an own-use import program, which is comparable to the GROU program in Canada, not the own-use import program. It requires registrant cooperation. The U.K. has a program that is very similar to GROU. It also requires the registrant cooperation.
The task force wanted us to note that it's the package of recommendations that is designed to address the issues, not any handful of specific recommendations. They are concerned that continuing with the own-use import program would have negative effects on access to new products not registered in Canada. There is a possible development of different business models if the own-use import program continues.
One of the things we certainly noted in discussions was the recognition of concerns from farmers and others about pressure on registrants to continue to participate in a positive way on GROU and some of the other recommendations.
We have considered some solutions, including maintaining the current regulation as a relief valve. We could keep GROU as the primary mechanism but continue to have OUI at the ready if there was no uptake by registrants on the GROU program.
The last slide on considerations notes some specific progress. At the last appearance, I noted that we were very close to registering our first NAFTA label. Both EPA and PMRA registered that first NAFTA label on January 31 of this year. Indeed, it has already set the tone for many other registrants, so we can have a discussion on several other products at the same time.
For the first time ever, we have also had a new chemical, not only submitted for joint review but submitted for joint review with the clarity at the outset that they want a NAFTA label at the end. This NAFTA label, for many, is the ultimate in price discipline because it allows free movement of that product across the Canada-U.S. border.
On the international front, there is also another development that I would like to report. That is that the PMRA with other countries, the United States, the United Kingdom, Ireland, Italy, Australia, New Zealand, and Japan, received an electronic submission from DuPont for the registration of the new insecticide. We consider this to be the first real OECD global joint review where it is clear that the intent is to get registration in markets in Canada, the U.S., Europe, and Asia at the same time.
We are also looking to do that in an expedited fashion to complete the review in 14 months, which is a significant improvement to the typical 21- to 24-month review standard if you look at those countries independently.
In December we released a proposal for a revised intellectual property policy that has three primary goals. One is to continue to support and promote innovator products coming to Canada by providing them with a certain period of data protection, but because we have been much clearer in the limits of that data protection, the intent is also to foster a generic industry in Canada.
When you register a generic industry and generic products in Canada, you really see an effect on price. To date in Canada that has been very limited. That's one of the key objectives of this new intellectual property policy.
The third objective we have with it is to encourage registration of minor use, because we will extend the data protection period in correlation with the number of minor uses that are there.
Before I turn to my colleagues who were also on the task force representing farmers, I want to note that we have provided the clerk with copies of the NAFTA label, which is of course done in both English and French, and as well with a fact sheet on the strychnine project, so that committee members can see them first-hand.