[Translation]
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.
[English]
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.
[Translation]
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.
[English]
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.
[Translation]
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.
[English]
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.
[Translation]
I would now like to take a few minutes to present the document distributed to the committee.
[English]
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.
:
Thank you, Mr. Chairman and committee members.
My name is Gordon Bacon with Pulse Canada. A copy of my presentation has been left with the clerk. Rather than read from it, I'd like to just make some comments about Pulse Canada's role on the task force and our observations on the recommendations.
First, I'd like to say that I wear two hats. One is the CEO of Pulse Canada and the Canadian Special Crops Association, and also I am a farmer. I would go into this task force with interests from many perspectives.
Working with the pulse industry, innovation has really been one of our keys. I think the success of our industry in the past has been on innovation. What we were looking for is a policy framework, a suite of options, that is going to address many of the issues that face farmers and access to crop protection products.
We had two goals in terms of going into the task force and being a member. One was to make sure that we had timely access to new products that our competitors have access to and that provide reduced environmental risk. We take stewardship as a very important issue. The second thing, of course, is having access to those products at competitive prices. It's about the competitiveness of our industry on an international stage.
Many in the pulse industry have benefited from the old OUI program, even on our farm, having used ClearOut as one of the products. We looked at what the industry needed, and when we looked at the four key replacement components to the old OUI program, we felt that the task force recommendations provide the industry with a great step forward. If they are introduced and acted on in the way they were brought forward in the task force, we feel this is a step forward for the industry.
Karen mentioned the technology gap that's being addressed. There are 26 products on the list that are of interest to the pulse industry. They include products from three companies that aren't currently present in Canada. Looking at how we can get access to product that the American farmer has through this narrowing of the technology gap is a key part of this suite of recommendations to replace the old OUI program. I think it's important to note that industry cooperation is going to be needed for companies that already have a presence in Canada, as well as companies that don't have a presence, to want to participate in that narrowing of the technology gap.
Karen has also mentioned the NAFTA labelling. People involved in this, including those in the pulse industry, have seen very rapid progress in the last year with great interest in pursuing NAFTA labelling. As has been mentioned, this is also part of the solution to price competitiveness and making sure there are no regulatory differences or geopolitical boundaries that start to enter into price differentiation.
Karen has also mentioned the introduction of a PSR III, product-specific registration III, as a way to update the regulations regarding the development of a generic industry in Canada. Obviously, the creation of a generic industry in Canada that closely mirrors what is going on in the U.S. will also be part of ensuring that we have price competitiveness on the Canadian side of the border.
Finally, we also feel that the GROU program has some advantages that need to be noted. One is that the equivalency does not have to be established by a farmer, or individuals acting on behalf of a group of farmers, which is a process that can be costly and time consuming. The equivalency is established through cooperation of the regulatory agencies and the registrant.
We, as Pulse Canada, were part of the group that signed on to the task force recommendations. When we looked at all four components of the program, we felt that this was a step forward. We think we need to act on the recommendations of the task force so that we can get each area started as quickly as possible. This will go a long way to sending the signal that we do have a regulatory environment in Canada that makes investing and bringing new products to Canada an attractive option to the companies that own these products. A key part of keeping our industry at the front of innovation is to make sure we have access to new products.
The task force perhaps can look at some additional work to ensure there are safeguards in place to ensure the pricing discipline component is acted on, but we do feel that this is an approach that addresses some of the deficiencies we have with access to products now. It's a framework to go forward to make sure we have access to new products. I'd be more than happy to answer questions when we get to that part of the presentation.
With that, Mr. Chairman, I'll leave my comments and turn it back to you.
:
Thank you, Chairman Bezan and members of the committee.
I've been given 10 minutes. Please excuse me if I use English. If I tried to do it in French, I'd need 100 minutes and wouldn't do it very well. I apologize for that.
A number of the points made by Karen and also by Gordon are things that I will skip over for my presentation. I want to focus on a couple of things.
The proposed GROU program for import is only a part of a much bigger suite of new programs and policies developed and recommended by the working group and signed for by all of the members. There was no dissenting vote. Everyone signed.
It's important to understand—and I don't have to tell you this—that when you sign an agreement that's made up of many parts, probably nobody is happy with all the parts, but in order to live with the totality of the agreement, there is enough in there for each person who signed that they were willing to swallow some parts they weren't happy with.
Cherry-picking of any piece of that agreement after the fact really negates the balance of the decision that was reached and signed for by all the players. If we start cherry-picking and taking things out or putting things in, some of the groups will leave the table and not agree to the package. When the steering group started, it was a very polarized group of people, and at the end we all came into the middle. It is important to recognize that there was all-party agreement to all the pieces that were brought forward.
In the interest of Canadian farmers, it has to be clear that the sum total of the benefits that were agreed to is greater than the net value, including the current flaws of the current OUI program. Included in this total of benefits, as was mentioned, is that there is no cost to growers to try to prove equivalents. There will be corporate support for the product issues if and when they arise. A far greater number of products can be identified on an annual basis and proposed annually for importation. A perfect program would mean nothing ever has to cross the border because price discipline would kick in. By actually nominating 50, 75, or 100 products for importation based on monitoring of prices by Agriculture Canada, which has agreed to do this, it would be a firm signal to the companies to get their prices in line, and all farmers of all commodities that those are registered on would gain the benefit far more than with one product that's part of the current program today. When that product is the largest selling pesticide in Canada, it's much more difficult for a whole lot of smaller market products to ever see the light of day under the current program.
There will be a container management program under the CropLife umbrella, which has been voluntarily been doing this for 20-odd years, and doing it very well. As I said, there will be support from Agriculture and Agri-Food Canada for a better and more comprehensive price monitoring program, so that growers could make a fair decision on whether something is a problem price-wise or not. Perhaps we can even find a way to solve some of the provincial legislative problems that exist with the OUI program and the NAFTA labelling program, and Gordon mentioned the need to solve the technology gap. We all agree with that.
In summary, the Canadian Horticultural Council is fully supportive of this suite of new programs. We are not in favour of the OUI program as it has been practised for the past two years, and that is because of the flaws in that program that were iterated earlier.
We recognize, however, that not all the players are as confident as we are, and we respectfully suggest that in order to give the GROU program a fair chance, a fair trial, the OUI program be suspended--not taken off the books, just pushed aside while the GROU program has a fair chance to show that it can work. If it doesn't work, the OUI is still on the books and it could be re-implemented the next day.
In order to determine whether the GROU program in a trial has been successful, there need to be a number of questions asked of it.
First and foremost, did price discipline occur? In other words, did the price gap close so that Canadian growers did not face higher prices than the Americans did? Second, how much product actually did come in under this program? If product is coming in, that means price discipline didn't happen. Third, did the issues of container management and product stewardship get resolved?
These are some of the warts in the current program. Can the provinces deal with the products coming in under the GROU program? Right now, nine to ten provinces' provincial legislation cannot regulate these products. They're orphan chemicals when they come in under the OUI program.
Did Agriculture Canada provide enough accurate data to allow appropriate decisions to be made? That's very important. When the PSR II is passed, the real test will be the number of new generic pesticide applications and the access of Canadians to Canadian-registered generics, which is the whole reason that pricing for a product like glyphosate has dropped the price in the U.S.
How many new minor uses have come into Canada? Has the PMRA's Project 914 to close the technology gap worked?
Then, and only then, can we do a fair evaluation of whether GROU is doing all that we think it can.
I'd like to thank you for considering all these points, not just some of them. And remember that all growers across Canada, for very many crops, stand to gain materially from the possibility of the advantages of all the new approaches the committee agreed to.
Thank you.
:
There continue to be two pressure points.
We are very successful on joint reviews. As I mentioned, we're now participating in the first global joint review. One date of submission has gone from DuPont to all of those countries. We're at the table with the U.S., the U.K., and our other colleagues.
The experience is such that whenever we've participated in a joint review to date, the decision, at least between Canada and the U.S., has been the same, i.e. to register. The use patterns haven't always been exactly the same, because obviously in the U.S. there are some use patterns that aren't the same as in Canada.
On going forward, we're clearly supporting joint review as the best mechanism. It's a good use of our evaluators' time. It provides farmers with access at the same time.
On the issue of data protection, the data protection would then end at the same time, and it really is a win-win for all parties.
There are still a lot of difficulties because of history and the fact that, as both Gordon and Craig have noted, there is an existing technology gap. At this moment in time, and for quite a long period of time, there's been a big difference in how many products U.S. farmers have access to, for how many uses, that Canadian farmers don't have access to.
That is where, for the first time, PMRA has really given thought to how we can address it. The Project 914 that Craig alluded to is to work to address the issue. Instead of taking a use-by-use kind of pattern, which is what we've done historically—as the pulse growers have said this is a priority, or the tobacco growers have said this is a priority, or the apple people have said this is a priority—we have looked at what chemicals give the most number of uses that are of interest to growers in Canada.
PMRA looked at three active ingredients, again with the cooperation of the registrants, because we needed to get their agreement for full access to data. Among those three active ingredients, there are approximately 250 uses associated with those three actives.
We're now at the point where, under our act, we have to consult on proposed new registration. We have said these meet our standard of evaluation. We're now consulting.
It is very unlikely that there then will be any issues. They will be approved, and with three chemicals, you get 250 uses approved. It helps to close the technology gap.
We're also talking with our U.S. colleagues about harmonizing the residue levels that are allowed and being very clear that we want to do it in a way that does not disadvantage Canadian growers. If Canadian growers want a use registered, our preference is to get the product and the use registered and not to set a residue limit that would allow U.S. product to enter into Canada.