HEAL Committee Meeting

37th PARLIAMENT, 1st SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Wednesday, April 24, 2002

¹

1535

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Dr. Claire Franklin (Executive Director, Pest Management Regulatory Agency, Department of Health)

¹

1540

¹

1545

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Dr. Claire Franklin

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

Dr. Claire Franklin

Mr. Rob Merrifield

Dr. Claire Franklin

Mr. Rob Merrifield

¹

1550

Dr. Claire Franklin

Mr. Rob Merrifield

Dr. Claire Franklin

The Chair

Mr. Howard Hilstrom (Selkirk--Interlake, Canadian Alliance)

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

¹

1555

Mr. Howard Hilstrom

Ms. Geraldine Graham (Head, Regulatory Affairs, Pest Management Regulatory Agency)

Mr. Howard Hilstrom

The Chair

Mr. Bernard Bigras (Rosemont--Petite-Patrie, BQ)

Dr. Claire Franklin

º

1600

Mr. Bernard Bigras

Dr. Claire Franklin

Mr. Bernard Bigras

Dr. Claire Franklin

The Chair

Mrs. Karen Kraft Sloan (York North, Lib.)

Dr. Claire Franklin

º

1605

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

º

1610

The Chair

Mrs. Carol Skelton (Saskatoon--Rosetown--Biggar, Canadian Alliance)

Dr. Claire Franklin

Mrs. Carol Skelton

Dr. Claire Franklin

The Chair

Mr. Clifford Lincoln (Lac-Saint-Louis, Lib.)

º

1615

Dr. Claire Franklin

Mr. Clifford Lincoln

Dr. Claire Franklin

Mr. Clifford Lincoln

Dr. Claire Franklin

Ms. Geraldine Graham

Mr. Clifford Lincoln

Ms. Geraldine Graham

º

1620

The Chair

Mr. Clifford Lincoln

The Chair

Mr. Basil Stapleton (Legal Counsel, Department of Justice)

Mr. Clifford Lincoln

The Chair

Mr. Rob Merrifield

Dr. Claire Franklin

º

1625

Mr. Rob Merrifield

Dr. Claire Franklin

Mr. Rob Merrifield

Dr. Claire Franklin

Mr. Rob Merrifield

Dr. Claire Franklin

The Chair

Mr. Jeannot Castonguay (Madawaska--Restigouche, Lib.)

Dr. Claire Franklin

º

1630

º

1635

The Chair

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP)

Dr. Claire Franklin

Ms. Judy Wasylycia-Leis

Dr. Claire Franklin

º

1640

The Chair

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

Mrs. Karen Kraft Sloan

Dr. Claire Franklin

Mrs. Karen Kraft Sloan

º

1645

Mr. Basil Stapleton

Mrs. Karen Kraft Sloan

Mr. Basil Stapleton

The Chair

Mr. Howard Hilstrom

Dr. Claire Franklin

º

1650

Mr. Howard Hilstrom

Mr. Basil Stapleton

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

º

1655

The Chair

Mr. Clifford Lincoln

Dr. Claire Franklin

Mr. Clifford Lincoln

Ms. Geraldine Graham

»

1700

Mr. Clifford Lincoln

Ms. Geraldine Graham

The Chair

Mr. Bernard Bigras

Dr. Claire Franklin

Mr. Bernard Bigras

»

1705

Dr. Claire Franklin

Mr. Bernard Bigras

Dr. Claire Franklin

The Chair

Mr. Bob Speller (Haldimand--Norfolk--Brant, Lib.)

Dr. Claire Franklin

Ms. Geraldine Graham

Mr. Bob Speller

Dr. Claire Franklin

Mr. Bob Speller

The Chair

Ms. Judy Wasylycia-Leis

»

1710

Dr. Claire Franklin

Ms. Judy Wasylycia-Leis

Dr. Claire Franklin

Ms. Judy Wasylycia-Leis

Dr. Claire Franklin

»

1715

The Chair

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

»

1720

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

Mr. Howard Hilstrom

Dr. Claire Franklin

The Chair

Mr. Clifford Lincoln

Ms. Geraldine Graham

Mr. Clifford Lincoln

Ms. Geraldine Graham

»

1725

The Chair

Ms. Geraldine Graham

The Chair

Dr. Claire Franklin

The Chair

Dr. Claire Franklin

The Chair

Dr. Claire Franklin

The Chair

Ms. Geraldine Graham

The Chair

---

CANADA

Standing Committee on Health

---

NUMBER 070

l

1st SESSION

l

37th PARLIAMENT

---

EVIDENCE

Wednesday, April 24, 2002

[Recorded by Electronic Apparatus]

¹  (1535)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen. It's my pleasure to call this meeting to order and to welcome our witnesses from the Pest Management Regulatory Agency, Dr. Franklin, the executive director, and Ms. Graham, the head of regulatory affairs, and from the Department of Justice Mr. Stapleton, who is legal counsel.

    We will open by giving the floor to Dr. Franklin.

    Dr. Claire Franklin (Executive Director, Pest Management Regulatory Agency, Department of Health): Thank you very much, Madam Chair.

[Translation]

    Thank you, Madam Chairperson and committee members, for inviting me to speak to you. I am here today to provide background information about the pest management regulatory system and the proposed new Pest Control Products Act.

[English]

    I will be providing some details about how the PMRA registers and re-evaluates pesticide, and will briefly describe international harmonization efforts and the minor use program, highlighting the support Bill C-53 will provide to these important areas.

    The long and complex process of developing a new pesticide usually begins in a company laboratory with the discovery of a new compound that has pesticidal properties. The company then must conduct extensive scientific studies according to internationally accepted protocols to learn about the health and environmental risks, effectiveness, and economic value of the new compound. Following an application for registration that includes the reports of these scientific studies, PMRA scientists evaluate the data and determine whether the product has value and can be used without harm to human health in the environment.

     The studies are designed to provide three key pieces of information, first, the toxic effect, second, at what dose level it appears, and third, the dose level at which are there no effects. This no-effect level is the starting point for the estimation of safety. Permissible levels of exposure in humans must be at least 100 times lower than this no-effect level. Depending on the type and severity of the toxic effect, even greater margins can be used. Bill C-53 recognizes children in particular, and a margin of 1000 times lower than the no-effect level will be sought. Both acute effects and long-term or chronic effects must be assessed in the studies that are conducted. Bill C-53 will also require that aggregate exposure and cumulative effects be assessed.

    Scientific data on the environmental fate and toxicity of a pesticide are part of the information package required to support registration. In assessing environmental risks, scientists consider the effects on wildlife and ecosystems, including endangered species and biological diversity. Potential risks posed by formulas are also included in our assessments. Other relevant information may be used by PMRA scientists during their evaluations, including the reviews by other reliable regulators and information provided by experts in other departments or universities. Further studies from the company may also be required. Based on this wealth of data, the potential risk to the general public, to workers manufacturing, formulating, and using pesticides, and to the environment can be determined. Only products that can be used safely are registered for sale or use in Canada.

    Like other leading pesticide regulators, the PMRA has a program to re-evaluate products that have been on the market for some time. Re-evaluation is critical to effective health and environmental protection. When a pesticide comes under re-evaluation the registrant is usually required to submit new test results to prove that the product can meet contemporary standards.

    The PMRA's enhanced re-evaluation program has as its target the review by 2006 of all pesticides registered prior to 1995 in light of new data requirements and modern standards of evaluation. Completing all these re-evaluations is a challenging task, made possible by using international reviews of data, particularly those of the U.S.A. Therefore, our timelines for re-evaluation are closely linked to those of the U.S. Environmental Protection Agency. As stated in Bill C-53, a re-evaluation will have to be undertaken no later than 15 years after registration for pesticides registered after 1995. Of course, the safety of a pesticide would be reviewed sooner than that if there were a report of an adverse effect or if there were an application for a major new use, at which time gaps resulting from new data requirements could be filled.

    Bill C-53 will further strengthen the re-evaluation program. Subclause 20(1) allows the minister to cancel or amend a registration if the registrant fails to respond to a request for the information needed to complete a re-evaluation or a special review.

    In Canada pesticides are thoroughly assessed and re-evaluated. It is because our regulatory system uses sound science as its basis and carries out its reviews and assessments to internationally accepted standards that the PMRA is able to work collaboratively with the U.S. Environmental Protection Agency and other major regulatory agencies on the international harmonization of pest management regulation. International harmonization is important because it supports efficient regulation, which in turn supports health and environmental protection. International agreement on what studies are required and how they must be done avoids needless duplication, both in the conduct of the studies and in the time-consuming evaluations.

¹  (1540)  

    In harmonizing the data requirements and in developing ways of working with our foreign counterparts to review applications to register new pesticides, our agency has taken great care to maintain this country's high health and environmental protection standards, not lower them. International harmonization arrangements do not change the minister's accountability to Parliament and the Canadian public for pest management regulation.

    In the Canadian-U.S. joint review program the two countries divide the work of evaluating the scientific studies the company has submitted simultaneously in both countries. The very first joint review program, announced in 1996, focused on reduced-risk chemical pesticides in order to promote rapid access to these safer products. The joint review program was then expanded to include biopesticides and replacement products for organophosphate pesticides and methyl bromide. It will soon include minor use products. The timelines for review in these joint programs are shortened.

    As of February 2002 24 registrations of new active ingredients have been granted through this harmonized program with the U.S. EPA. This includes nine reduced-risk chemicals, two microbials, and two pheromones, as well as ten traditional chemicals and one minor use. There are currently 30 submissions undergoing joint or work-share reviews. This represents more than 50% of the new active ingredients being submitted for registration in Canada, and is a significant advancement in registering newer and safer products in a timely fashion.

    Levelling the playing field for Canada-U.S. trade in agricultural products treated with pesticides is very important for Canadian growers. With the joint review and work-share arrangement, it is much more likely that a pesticide will be registered in both countries at the same time and agricultural products can be traded without impediment and without comprising health and environmental standards. Bill C-53 supports harmonization, because it makes Canada's pesticide regulatory system more transparent, allowing the PMRA to share scientific studies and evaluation reports with international regulators.

    Bill C-53 supports risk reduction in several ways.

[Translation]

    The joint review process includes biopesticides such as microbials and pheromones that often address the needs of the niche markets that are growing in importance and that rely on integrated pest management.

[English]

    Bill C-53 ensures that products that do not make a contribution to pest management are not registered, that the lowest possible application rate is used, and that conditions of registration are set so that risks are minimized. The bill also supports application of the substitution principle by providing authority to conduct comparative risk assessments and allowing registrations to be refused or cancelled after a re-evaluation if safer alternatives are available. This is similar to the approach in countries such as Sweden and Denmark.

    I'd like to now say a few words about the minor use pesticides. Projected sales of some pesticides in Canada are so low that manufacturers have no incentive to support Canadian registration. For purely commercial reasons, therefore, such products may not be available for use in this country. Many of these minor use products are regarded as essential to cost-effective pest control and to the competitiveness and sustainability of agriculture, forestry, and other sectors. I might add that this situation is not unique to Canada, and we, along with Agriculture and Agri-Food Canada, are looking at how other countries are dealing with this problem.

    The PMRA has been working to make the pesticide regulatory system for minor use products as efficient as possible by having separate submission review streams with shorter timelines. It has waived or significantly reduced application fees for minor uses. PMRA is also going to create a minor use adviser position and give priority to the registration of reduced-risk minor use products. Agriculture and Agri-Food Canada is looking to identify ways and means to provide the assistance growers or sponsors need to generate the data to support minor use applications.

    In closing, Madam Chair, I would like to emphasize my belief that Bill C-53 will strengthen the regulatory framework for pest control products and enhance protection for Canada's health and environment.

    Thank you.

¹  (1545)  

    The Chair: Thank you, Dr. Franklin.

    We'll proceed to questions by the committee members, and we'll begin with Mr. Merrifield.

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you.

    I want to thank you for coming, and coming twice, as a matter of fact.

    Dr. Claire Franklin: I thought I heard a bell today, so I thought it might be three times.

    Mr. Rob Merrifield: I was a little nervous about that myself, to be honest. But I'm glad to be able to have you here to explain what the PMRA is doing. Your briefing and what you just said put a lot of questions in my mind. Yesterday we had a number of interesting groups come and testify that they're having a very difficult time on the efficiencies, the timeliness, minor uses, with the PMRA. Because of that, CropLife Canada actually came up with five recommendations. It's just an opening, because I think lots of what you have just said goes along with what they're saying, and yet we're not seeing it in the piece of legislation. So could you comment on their amendments, and would you have a problem with what they're recommending, where they'd apply, where they wouldn't apply? What do you see as a problem or not a problem?

    The Chair: You may not have had time. It was only yesterday that those amendments came forward.

    Mr. Rob Merrifield: I realize that. To give you fair opportunity to respond, if you're not prepared now, would you please respond in writing, because I think it's very important that we get your response on that. I can ask the questions more directly and wait for your written response.

    When it comes to the time limits of getting a product into a market in Canada, you're suggesting that it's very important we do harmonize and not retard the new generation of pesticides coming onto our market. Is that a fair statement? If that is the case, why would timelines not be part of the bill?

    Dr. Claire Franklin: We certainly have worked very hard over the past number of years with, in particular, EPA to establish a capacity to do joint reviews. Because there have also been comments that we don't have an expedited process for reduced-risk chemicals, I would add that the joint reviews we implemented after 1996 were for reduced-risk chemicals, microbials, and pheromones. So there really is an expedited review for those and a timeline that we meet together with the U.S. When the submission comes in, we finish the submission at the same point in time.

    Mr. Rob Merrifield: To get exactly what you just said there, you're saying that's your goal or that's what's happening?

    Dr. Claire Franklin: That's what is happening. In 1996 the program was put in place, industry was invited to put submissions in, and, in fact, a number of companies have put them in, but the program is there for companies to apply to. What I want to emphasize is that we put in, as the very first ones in that area, reduced-risk chemicals, and then the microbials and pheromones. We wanted to emphasize earlier access to those products, and we wanted to have them available to Canadian growers at the same time as to U.S. growers. So those programs are in place and have been for many years now.

    Mr. Rob Merrifield: I'm just trying to put it together with what we heard yesterday from witnesses with regard to the PMRA and the difficulty they're having. They certainly were quite unanimous that there seems to be a shortage of funding, or the regulations are too thorough, or the efficiencies of the operation are compromised. In fact, we asked that question, and they said, all and more. So have you worked to improve the efficiencies? Do you have the proper funding to deal with the issues you have to deal with? Where's the problem?

¹  (1550)  

    Dr. Claire Franklin: We established, when the agency was started in 1996, that we would set up a performance standard for review of submissions of 18 months, which is what the multi-stakeholder review asked us to do. We put that in place, and as I believe I've said to various groups, we meet that performance standard 88% to 90% of the time, which was our target.

    Mr. Rob Merrifield: With the new legislation, you're suggesting it's going to be better. How many further resources do you think you'll need, or do you need any further resources to be able to follow the mandate set up in the new piece of legislation?

    Dr. Claire Franklin: We clearly identified, when the consideration for introduction of the bill was being made, that there would be a necessity for additional resources for us to be able to implement the extra pieces of responsibility we would have as a result, and I'm pleased to say those resources were approved. So we believe that for the extra work we're taking on board, we have reasonable resources to enable us to deliver on that.

    The Chair: Thank you, Mr. Merrifield.

    Mr. Hilstrom will conclude the Alliance's ten minutes.

    Mr. Howard Hilstrom (Selkirk--Interlake, Canadian Alliance): The legislation before us indicates to me that strengthening the reduction of use of pesticides is what this is all about. You're going to reduce the amount of pesticides available to keep Canada competitive in this field. Let's just talk about your performance for a minute in the PMRA.

    The Canadian Consumer Speciality Products Association used access to information. You say it's 88% to 90% of the time that you meet the performance standards. Here's what the access to information turned up. On the priority items your standard was two years and 2.2 months, but it was 77% longer, which is close to three and a half years longer than what your performance standard is. In regard to the standard pesticide items, your performance is supposed to be two years, 11.6 months, which is just about three years, and the information shows you exceeded that by 171%, which is almost eight years above your own guidelines. Is this information your department supplied to Canadian Consumer Specialty Products wrong? ?

    Dr. Claire Franklin: The person who requested it was provided with information that said the time a submission came in and the time a submission was registered. That was done product by product. That's the information that was provided.

    I've just had a chance to have a quick look at the comments. I don't understand what the numbers are that were used. They simply don't match up with what I understand the performance standard to be. And our performance standard is very clear. We have a time to screen it, a time to review it, and then there's a time to have a label established. The time that a company takes, that's our time. If the submission comes in and it's incomplete, the company is given an opportunity to add in what's missing. I don't think there was any attempt to try to put in the amount of time industry takes.

    Mr. Howard Hilstrom: Bill C-53 is the biggest deal in regard to pesticides in the last 20 or 30 years. I appreciate that this information just came out of committee yesterday, but what are you folks doing in that department that you can't even have time to review the information that came in yesterday from witnesses, but come here today without answers to these kinds of questions? I find that really strange.

    Dr. Claire Franklin: My comment, sir, is that the numbers in that document, which I have looked at, I don't understand. They don't match up with any of the information we've provided that says what our performance standard is. I will point out that the time we take to review submissions is comparable to the time that's taken within the U.S. EPA. We take, on average, 29 months. That includes company time for a poor-quality submission, if they take extra time, and our time. In the U.S. it's 27 months. For the category B submissions, we take 15.4 months total time; in the U.S. it's 31 months. I'm a little confused as to why that doesn't happen to be a reasonable timeframe, when we're as good as or better than the country with which we're always being compared.

¹  (1555)  

    Mr. Howard Hilstrom: At some point it's will have to be sorted out. The industry people are trying to be very polite, because they have to work with your department, they're trying to be fair, but we hear repeated complaints about that performance.

    You say only products that are registered for use in Canada can be used in Canada. With the sunflower situation in Manitoba, we have U.S. producers coming up--I believe this is for Madam Graham--contracting with Canadian growers. They bring up seed. Not only is the seed not registered, but it comes up with two fungicides on it called Captan and Maxim, which are not licensed by Health Canada or the PMRA for use on sunflowers in Canada. The person from the PMRA who spoke to this issue was a Bruce Peloquin. He's the PMRA regional pesticide officer, and he says the agency allows unregistered products to be used in Canada on a case-by-case basis. How does that fit in? Is that true, Madam Graham? How is this legislation going to deal with that kind of issue? How come the harmonization hasn't worked the way you say it has since 1996? This is another confusing issue.

    Ms. Geraldine Graham (Head, Regulatory Affairs, Pest Management Regulatory Agency): Pesticides cannot be used in Canada unless they are registered. If they are coming in on food, they have to comply with maximum residue limits under the Food and Drugs Act. I'm not familiar with the particular case you're talking about, so I can't comment further.

    Mr. Howard Hilstrom: I don't know, Madam Chairman. I would just mention that there's a Bruce Peloquin, and you should ask him. He's a regional pesticide officer. He said Captan and Maxim are coming in.

    This goes back to the same question we're trying to get at. The government can pass the best legislation in the world, but if the PMRA, as a directorate, is not functioning, or is functioning so poorly, where is the advantage to Canada, either competitively for the farmers or in protection of our children and seniors?.

    Thank you, Madam Chairman.

    The Chair: Thank you, Mr. Hilstrom.

    We'll go on to Mr. Bigras.

[Translation]

    Mr. Bernard Bigras (Rosemont--Petite-Patrie, BQ): Thank you, Madam Chair.

    I would like to come back to the bill. As we can see, the bill sets deadlines for the re-evaluation of products, in that—and this is clearly indicated in the bill—there is provision for reviewing the bill at some point in time.

    But we do not see any clear timeframes for the completion of this process. Yes, there is provision for re-evaluation—it is clearly set out in the bill—, but there is nothing to indicate a final completion date. When we look at the existing situation and the work being done by the PMRA, I have to say that I find this rather worrying.

    My question is therefore as follows. In order to be sure that there is a clear procedure, not just at the beginning, but right through to the end, would it not be desirable to make provision for the entire process in the bill, i.e. a beginning and an end, so that we can ensure that the public's health will be protected? As an agency, you are responsible for providing a product which is properly re-evaluated, not just at the point when the re-evaluation begins, but at the point when it concludes as well.

[English]

    Dr. Claire Franklin: Over the past several years the agency has gradually got additional resources for re-evaluation. It's an area where, prior to formation of the agency, there were limited resources, and we have steadily been increasing the amount of activity for re-evaluation. With the new resources we get, we will be even further able to do that.

    The identification of a specific timeframe within which to do a re-evaluation is very challenging, because when a re-evaluation is started, there may actually be information that's required, and time may have to be given to review information that comes in as a result of a call for a re-evaluation.

º  (1600)  

[Translation]

    Mr. Bernard Bigras: Are you aware of any products which were in the process of being re-evaluated and which, during that process, became dangerous to public health? That is my question. Did you notice at some point during the re-evaluation process, which can take years, that there were children whose health had suffered? Have you become aware of such cases during the current process?

[English]

    Dr. Claire Franklin: I'm not aware that during the process of a re-evaluation we have identified anything so catastrophic that action had to be taken. If there were, one would not have to wait to finish a re-evaluation. The minister would have the authority to cancel or suspend that right at that time.

    The other thing I would like to mention is that if an issue comes along on a product that hasn't been scheduled for re-evaluation, we have a category called special review. If there is some information to suggest that something needs to be looked at, that's a way to look at something more rapidly. So it is not a matter of having to wait for a certain point in time. We're hopeful that with the adverse effects reporting that will be part of the requirement with this legislation, we will also have more information provided to the minister in a timely manner that we will then be able to see. It may be that some of this information would indicate that a look should be taken at that immediately.

[Translation]

    Mr. Bernard Bigras: Do you feel that this bill is fully consistent with the precautionary principle? I will not have time to ask a second question, but if you feel that it is, what makes you say so, when there is only one clause in the whole bill which refers to the precautionary principle, and that is clause 22?

[English]

    Dr. Claire Franklin: For a new product, the precautionary approach is that it's not registered or put on the market until the minister is satisfied that the information indicates the product can be used safely. For products that are already on the market, there are several ways in which action can be taken. One can be as a result of a scheduled re-evaluation, which may lead to restrictions on uses of that product or a cancellation of the product. That is a full sequence of events. Special reviews may indicate that something needs to be done, and the minister would take action on the basis of that. The third thing we have identified, which really does reflect the precautionary principle, is that there may be scientific information that may not have all the pieces of information one would ultimately see, but sufficient to require the minister to take action. With those three steps, there is reason to believe action can be taken, as appropriate, on a product that's on the market.

    The Chair: Thank you.

    We'll go now to Mrs. Kraft Sloan.

    Mrs. Karen Kraft Sloan (York North, Lib.): For clarification, are you talking about products that are already on the market with regard to the precautionary principle?

    Dr. Claire Franklin: That's correct. For products that are not on the market, they don't get on the market if there's any concern about the adequacy of the data to support safety. Pesticides must be registered, they're not just out there. They have to be registered to be put on the market, they're registered while they're on the market, and we have the opportunity to have them taken off the market.

º  (1605)  

    Mrs. Karen Kraft Sloan: Do you mean the precautionary approach or the precautionary principle?

    Dr. Claire Franklin: As you are aware, from the government perspective, they have not differentiated between approach and principle.

    Mrs. Karen Kraft Sloan: I want to ask you a question regarding the registration of new products, and it has to do with the precautionary principle itself. In your brief you have stated that the company conducts scientific studies according to internationally accepted protocols. How is the precautionary principle operationalized through these testing protocols? Are there documents or criteria laid down as guidelines to show that the precautionary principle is being operationalized and utilized with the testing protocols?

    Dr. Claire Franklin: The data required to make a decision on a pesticide are very extensive. We have information on acute effects, short-term effects, and chronic effects. Every product has to be tested fully. It's not like products regulated under CEPA that are trigger-dependent. You have to have all these end points tested. There are reproduction studies, cancer studies, all the types of end-points. Levels must be high enough to show effects, so that we know what the effects and what the end-points are.

    Mrs. Karen Kraft Sloan: The question has to do specifically with the precautionary principle, and whether any of these internationally accepted protocols actually include the words “precautionary principle.”

    Dr. Claire Franklin: It's very unlikely that they do. Most of these protocols were established before the concept of precautionary principle came along. But with all of the testing that's done, we have information, we're able to determine what the level is at which the effects are, and we determine, as I said in my comments, that the minimum amount of exposure would be 100 times lower, and for-end points or sensitive subgroups we're concerned about, it would be 1,000 times lower, so it is not an issue that there is potentially something going on. We have that information ahead of time.

    Mrs. Karen Kraft Sloan: But within the field of risk assessment, allowing these margins of 100 times or another factor of 10 for children, a lot of this stuff is fairly controversial. There are people looking at both sides of this issue and wondering if these margins are really applicable in certain situations.

    I also wanted to ask you about what health end-points are measured, and you have indicated a couple of them. What kinds of health end-points are assessed through these testing protocols? Also, how are endocrine-disrupting substances dealt with?

    Dr. Claire Franklin: We would have studies that would look simply at acute effects. You'd be looking to see if there would be effects on the various systems, the kidneys, the liver, the heart, the brain, the nervous system, the endocrine system. In addition to short-term studies, there would be studies that would be conducted for two years, so that there would be that range of effects. There are teratology studies done looking for developmental affects, terata in offspring, in at least two species. There are multi-generation reproduction studies, where you would be dosing two generations. So in those kinds of studies full histopathology and toxicology are done. You would see whether there's an impact on the endocrine system in those kinds of studies. You see if there's an impact on the immune system. If you see impacts on the immune system in those studies, there's another battery of tests that can be done to further explore if there are effects on the immune system. The nervous system is looked at. If there's any indication that there'd be delayed neurotoxicity, there are specific studies done for those kinds of things.

    So the full range of studies is done prior to a product's even being considered eligible for registration, and all that information would be looked at. If anything comes up in those studies that triggers a suggestion that something requires additional study, that would be requested before we would make a decision on allowing a product to be registered.

º  (1610)  

    The Chair: Thank you.

    We'll move on to Mrs. Skelton.

    Mrs. Carol Skelton (Saskatoon--Rosetown--Biggar, Canadian Alliance): One of the concerns raised yesterday was that the provisions of Bill C-53 will take some products off the market. They just won't qualify for registration. Do you see the need for generosity to be granted, so that the market can have the time to introduce newer, safer pesticides, and our producers won't be left without adequate products?

    Dr. Claire Franklin: If I understand your question, it would be because of more attention paid to re-evaluations that products might be removed, certain uses would be removed. Would we be prepared to allow these products to stay on the market while alternatives were being either developed or registered?

    Mrs. Carol Skelton: Yes.

    Dr. Claire Franklin: That's a very challenging question. If the re-evaluation suggests that there are unacceptable effects, that the margins aren't large enough, if health or environment is affected, the minister will not be in a position to continue the registration of that product while there is development of alternative products. If the registration indicates that the margin is okay, but we would like to see a different margin, because we have an increased interest, and in the short term there may not be additional effects, there is an opportunity there to try to encourage registrants to get some alternative products in. But that could only happen if there is no indication that there would be unacceptable risks to health or environment.

    The Chair: Thank you.

    Mr. Lincoln.

    Mr. Clifford Lincoln (Lac-Saint-Louis, Lib.): Thank you, Madam Chair.

    Dr. Franklin, I would like to make a couple of remarks about the mandate, and ask you questions afterwards.

    I suggest to you that acceptable risk, which is the primary objective of the bill expressed in subclause 4(1), should be defined. I know there is an indirect definition in clause 7, but I suggest to you that there's no clarity as to an acceptable risk, and I think it should be defined.

    Also, I suggest that on mandate, under subclause 4(c), we add public education in there.

    My question refers to clause 11 first. Can you tell us why, when we assess aggregate and cumulative exposure, we only consider it in connection with maximum residue, when the review committee certainly suggested that we look at it in connection with a threshold evaluation itself, which is a very different thing? In other words, if we do it for the threshold evaluation, the maximum residue takes care of itself. So we need it on both. I would like to know that.

    Also, with subclause 21(3), we suggested a substitution principle on the lines of the Swedish code, which really promotes substitution products and alternatives. In this subclause it's a reverse substitution principle, where you say “the Minister may delay the effective date of the amendment or cancellation if no suitable alternative to the use of the pest control product is available”. It leaves a complete loophole. It should be a far more positive principle, rather than a reverse principle.

    Finally and more importantly, where all the regulations are made, the guts of the bill, in paragraph 67(1)(z.4), where the Governor in Council may make regulations, it says:

exempting pest control products, persons or activities from the application of all or any of the provisions of this Act or the regulations, and prescribing the conditions under which they are exempt

(i) for the purposes of facilitating scientific research or dealing with an emergency situation, or

(ii) if the Governor in Council is satisfied that the exempted products, persons or activities are sufficiently regulated under another Act...

    It seems to me that this is a huge escape hatch that we can use to say, oh well, we don't want to prescribe regulations, because we're going to exempt any pest control product if there's scientific research being carried out. I think this is totally unacceptable. If nobody presents an amendment, I'm going to, to delete this. If we leave this in, it seems to me the act can be changed at any time we want.

    Maybe you could comment on these points.

º  (1615)  

    Dr. Claire Franklin: Yes. I'll start with some, and then I will ask legal counsel or Geraldine Graham to help me.

    With regard to aggregate and cumulative, you're quite correct. It is identified in the section on MRLs. The reason for that was to show parallel structure for the way in which these extra factors were put in the U.S. FQPA legislation. We do aggregate and cumulative for non-food pesticides. There would be, of course, aggregation from other sources, water or surface sources. Obviously, if it's a non-food use, there wouldn't be a food source for that. We do that in our risk assessment. The intent here was to show that in this area it would be similar to the way in which it was done within the Food Quality Protection Act.

    Mr. Clifford Lincoln: If we do it, why don't we say it?

    Dr. Claire Franklin: We could.

    Mr. Clifford Lincoln: I think we should.

    Dr. Claire Franklin: There's no question that we do that. It was really a matter of having that parallel structure. I'd just point that out.

    With the second point you raised, on substitution principle, I'm going to ask Geraldine to respond, as she's more familiar with the specific details on that. I don't know whether Basil or Geraldine would be better to address clause 67.

    Ms. Geraldine Graham: With regard to the substitution principle, subclause 21(3) was really the subject of the previous question, where people were asking, if you come to the end of the re-evaluation, can you delay cancelling or amending, if there's no alternative? That provision does allow that, but only if the risk to value would be acceptable for the interim period. As far as the substitution principle goes, the way we implement it in the bill is in subclause 7(9) and subclause 19(4), which gives the minister authority to compare the value of one pesticide with another. If you look at the policy documents that support the implementation of the so-called substitution principle in countries like Sweden and Denmark, they call it comparative risk assessment. They make comparisons when there are two products that can be used for the same thing, are equally effective, and have substantial differences in their risks. In that case, the one with the lower risk would be favoured.

    Mr. Clifford Lincoln: It says the minister “may”, so I would much rather have the Scandinavian model. At least it's very clear as to what he does.

    Ms. Geraldine Graham: I think even there it's only done very judiciously, when there are clear, very significant differences in risks and the two products are the same. They don't do it all the time.

º  (1620)  

    The Chair: Thank you, Mr. Lincoln.

    Mr. Clifford Lincoln: Excuse me, but regarding paragraph 67(1)(z.4), I think that's a big point, and I'd like an answer some time. If there's no time now, I would like to have some answer.

    The Chair: We'll take that answer now.

    Mr. Basil Stapleton (Legal Counsel, Department of Justice): I should point out first that this is not a new concept in the act. It's been in the existing act since 1970, and indeed, in a more general uncontrolled form. In the current act there is authority to make regulations exempting any controlled product or any person or any class of controlled product or persons from the operation of all or any provision of the act, prescribing the conditions for exemption. So in effect, we're continuing what's in there, but we're putting more parameters on it to make it very clear. It goes without saying, in any event. The regulation-making authority is restricted in how it can be used. It cannot be used in a way to undermine the objectives of the act. There are in the regulations at the moment exemption provisions that have been in place for a long time and accommodate things like research. As far as I know, this hasn't been a source of difficulty.

    One of the interesting things about this act and the present one is that the definition of controlled product is so broad and the definition of pest is so broad that they catch just about every substance and every pest imaginable, even if there is actually no risk involved in relation to the product. So to have to go through a whole registration process with respect to every conceivable substance that comes within these broad definitions, I think, would be unnecessary and really a waste of resources.

    The alternative to narrowing the definition and leaving some things out is to broaden the definition, but then give authority, as appropriate, to exempt certain categories. Mind you, this can only be done through the regulation-making process, which means there is public consultation, public input, so that everybody gets an opportunity to see what exemptions are being proposed and to comment on them. Essentially, that's the logic of the thing now.

    Mr. Clifford Lincoln: I hope I'll have time after to debate the logic of it with you.

    The Chair: Thank you, Mr. Lincoln.

    We'll move on to Mr. Merrifield.

    Mr. Rob Merrifield: I think Mr. Lincoln is a little concerned about what's actually in the bill, what it actually says, compared to what the intent might be. I am as well, maybe from a different perspective. I'm still trying to wrap my mind around the difference between what we heard yesterday with some of the witnesses and what we're hearing today with regard to the efficiencies of the PMRA. We've talked about harmonization with the U.S. since 1996. Some of the information I have seen indicates that the number of pesticides that are registered in the United States is considerably larger than in Canada. Is that true, and could you tell us the number?

    Dr. Claire Franklin: It's rather interesting. We have actual full data from the U.S. for 2000-2001 year, and they registered, as best as I can add up from their information, 21 or 22 new active ingredients. We in Canada, for the same year, registered 12 or 13 new active ingredients. Considering that they have a much wider range of crops than we have--many of their products are for corn, for citrus, for crops we don't grow in Canada--the number of submissions and the new actives we're registering is not significantly different.

    Whether a company makes a joint application is really up to the company. We have put a process in place with a shortened timeframe to encourage companies or registrants to come in and utilize this particular program. And as I point out, we've emphasized the reduced-risk products, because we really want to encourage availability of those products in Canada. It doesn't mean every company is going to file joint applications, but we're certainly seeing a significant number of those. We see approximately 50% of our submissions coming as joint or through work-shares. So the gap is closing, in my view. The head of the EPA and myself do meet with industry to try to encourage them to do their product development in such a way that they can actually come into both countries at the same time. We're seeing more and more applications coming in this way each year. That's the way in which growers in Canada are going to have access to these products at the same time. If we get products that come into Canada two or three years after they've had them in the U.S., it doesn't matter how efficient we are.

º  (1625)  

    Mr. Rob Merrifield: I know that's a very definite concern. Let's get into some of the specifics. How many pesticides are on the market now that have been there for 15 years and will be required to undergo re-evaluation under this new piece of legislation?

    Dr. Claire Franklin: We have 550 active ingredients registered.

    Mr. Rob Merrifield: Okay. How long would it take to review those products?

    Dr. Claire Franklin: The target we're working towards for re-evaluation of the products that were registered prior to 1995, with approximately 400 active ingredients involved, is 2006. We're doing that in very full collaboration with the U.S. Environmental Protection Agency. The document we put out, the policy that indicated how we would be doing re-evaluations, clearly articulates how we will be proceeding to work towards that target.

    Mr. Rob Merrifield: And those are achievable, obviously, from your perspective.

    Dr. Claire Franklin: We are certainly affected by whether the U.S. meets that target. We've stated very clearly that our capacity, with the resources we have available, is dependent on our working very collaboratively with the U.S. EPA on that. So if they have delays, there will be consequent delays here. They are legislated to get those done, so they're certainly working very actively to meet those kinds of targets.

    The Chair: Thank you, Mr. Merrifield.

    Dr. Castonguay.

[Translation]

    Mr. Jeannot Castonguay (Madawaska--Restigouche, Lib.): Thank you, Madam Chair.

    I want to come back to the point Mr. Lincoln made.When you refer in your material to acceptable and unacceptable risks, in the end, depending on who is making that decision on a given day, this can, I think, vary enormously. Do you not think that it would be wiser to define clearly for everyone what constitutes an acceptable risk and what constitutes an unacceptable one?

    My second question has to do with the approval of minor use products. I have learned to listen to people at Agriculture who tell us not to go that route. I can understand that there appears to be a problem because, very often, those who manufacture these products do not apply for approval in Canada. Why? Is it because the costs are exorbitant? How could approval of these products be improved?

    On the principle of substitution, I understand that when there is a product that is less risky, another riskier one will be eliminated. Here again, if the risk, even if it is higher, is still acceptable, is it not important to keep a variety of products?

    Obviously, I am a bit biased, because I sometimes think of medicine and I tell myself that resistance to certain products often develops. The same phenomenon can occur with pesticides and, at some point, is it not preferable to be able to rotate these products so that if they present acceptable risks, even if we add another to the list, they should not be kept.

[English]

    Dr. Claire Franklin: You comment on acceptable risk. I would like to point out that this isn't a sliding scale: one day we determine or somebody else in another country determines acceptable risk. We have gone through a risk assessment. We're then looking for the level of no adverse effect in that study, or the most sensitive one in all the studies we've done. So it could be a reproductive end-point, it could be teratology end-point, it could be a cancer end-point, it could be any of those. We would be looking for the level at which we don't see risk, and then we apply very internationally accepted levels below that. So if it is a very minor effect that may recover when there's no exposure to the product, it's considered that a margin 100 times lower than the no-effect level would be acceptable. If it's a more significant end-point that there's concern about, we would be looking for a margin much larger than that.

    The reason we don't try to define this in legislation is that there is a whole range here. It would depend on what the end-point is, so it would be very complicated. I'm not aware of any legislation dealing with these kinds of products that actually puts a number like that in. The only thing I'm aware of is that they have added in the U.S. legislation for pesticides, as we have added in the Canadian legislation, an additional tenfold factor, but that's not saying it's a specific number. That would be a very challenging thing to do, and it would be changing as we get additional science. It should be very clear that this isn't a sliding scale, these are internationally accepted ways of doing this sort of thing.

    As to minor use registration, companies do not go in for minor use registrations, to the best of my knowledge, in any country in the world. How do other countries deal with that? In the U.S. they have a very significant program, where the Department of Agriculture has put in a very significant amount of money to generate the data that are needed, the data the industry itself will not generate. They just don't feel that it's economically viable for them to spend the money to generate the data. That happens around the world, even in countries as big as the U.S. So there's a program costing approximately $25 million Canadian. The U.S. Department of Agriculture makes money available for the data to be generated, so that the submissions can be then made and the decisions taken. We don't have a program. We're really working with Agriculture Canada now to see if we can come up with something like that. It's not appropriate for us, as a regulator, to be generating the data. That would be like generating the data, then reviewing it and saying it's all okay. It isn't done that way in other countries. In Australia there's money that the grower groups put in. The federal government puts money in and the growers put money in, and it appears to be about a 50-50 kind of relationship.

    So that's how other countries are handling generating the data required to support minor uses. It's not a uniquely Canadian problem with the pesticide industry not doing it, but in Canada we don't have a very significant program that allows generation of those data to come forward.

º  (1630)  

    Your third question was on substitution. If we have products that are of less risk, would we then work our way down to having only one product and perhaps eliminating all the others? As Geraldine points out, substitution is not easy. Countries have tried it, and it is not an easy task to identify whether a product is actually less problematic than one that's already on the market. We do see resistance with pesticides, the same way we see resistance with antibiotics for treatment of humans. We see resistance with a number of products. Insects are very capable of becoming resistant very quickly, so we do try to have a range of products, so that you're not just focusing on one, gradually having to increase the level, and it ultimately doesn't work at all. All that would have to be taken into consideration in looking at the comparison of risks or efficacy for products.

º  (1635)  

    The Chair: Thank you.

    Mrs. Wasylycia-Leis.

    Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you, Madam Chairperson.

    Forgive me if I ask questions that have already been posed, but I need clarification on this whole issue we touched on with the minister, when, Ms. Franklin, you were present, the process under way in the PMRA for the review of all existing pesticides from the point of view of safety and risk to human health. Maybe you've answered this already. According to reports I've read, that was part of the original mandate of the PMRA, which now has been in existence, at least under Health Canada, for seven years. In 1999 Mr. Emmett, the environment commissioner, made a very strong statement about a lack of progress in this regard. What I'm wondering about is a status report on that review.

    Dr. Claire Franklin: It went back a period of time to have a look at what the activity was. There is no question that the resources we had to put into re-evaluation were fairly limited then. Subsequently, the government has provided additional resources for re-evaluation activities. Industry has expressed concern. I think the concern is that we're going to take money away from registering new products to do registration of older products, and that is not the case. The government has, in fact, put resources in, and there are additional resources as part of implementation of this legislation, so that there is a much more active program.

    In the intervening time, as well, we've been much more actively involved with the U.S. EPA. The U.S. government has had a very aggressive re-evaluation program since the early to mid-1980s, and they've actually gone out and done data call-ins. They have identified the gaps in the older products. Industry has had an opportunity to generate new studies, and the databases for products industry is interested in updating are actually updated.

    I think there has been significant progress since that time, both with new resources and a much tighter relationship with the U.S., so we do not repeat reviews of the active ingredients when we have access to the reviews they have done. It doesn't mean we rubber stamp what the U.S. does. There has been, perhaps, a little concern about that. What we're doing is maximizing what we can get with the reviews they provide to us, but we also have to look at what we have, because the use patterns can be different from one country to another. Now that we're talking much more on aggregate and cumulative risk, we really have to take into much greater consideration the specific uses, because we may have different uses and the amount of exposure may be greater or less than it is in the U.S. We really do need to have some resources that we add on ourselves, so that we really understand what the Canadian situation is too.

    Ms. Judy Wasylycia-Leis: I'm still not clear. Of all the products on the market today how many have been reviewed? What's that status report on each one, based on either independent studies we've done here in Canada or studies we've used from other jurisdictions? What's the current status of every pesticide on the market today?

    Dr. Claire Franklin: That's not information I have at my fingertips for every active ingredient, but I can say that the re-evaluation program the U.S. implemented was “worst first”; they started with the organophosphorus products. We have 22 or 23 organophosphorus products registered in Canada. We're in the midst of that, because in assessing cumulative risks, the science is just being put together. We will then move through to the next layer, which will be the carbamate products, and so on, so that by 2006 we will be through the 400 products that we have currently registered.

º  (1640)  

    The Chair: Thank you Mrs. Wasylycia-Leis.

    We'll now go to Mrs. Kraft Sloan.

    Mrs. Karen Kraft Sloan: Thank you very much, Madam Chair.

    I wanted to ask you a couple of questions about the Canada-U.S. joint review program. I know, as you stated, you're involved with that. I'm wondering how the precautionary principle has been operationalized through that particular process and if there is anything identifying the precautionary principle in the documents that have been developed for that particular review process.

    Second, I was in the United States last fall and spoke with some people who have been heavily involved in the issue of child environmental health. While they have applauded the use of the 10 times factor, taking into consideration exposure for children, they said it's usually limited to three times or seven times. Very seldom have they seen 10 times being used. I'm wondering whether, if Canada is harmonizing with the United States, even if this legislation calls for 10 times, we'll only be looking at three times or seven times.

    Dr. Claire Franklin: The words “precautionary principle” do not appear in any of our joint review documents. As I've indicated, we believe the whole approach to pre-market review of submissions, which the joint review is, is a precautionary approach. Products are not put on the market if there are any questions, any gaps, any concerns about whether the margins are appropriate.

    The way the legislation is written, it does indicate that we could use a lower or a higher factor than 10. The reason one puts on extra margins is that if you're not certain, if you have indication of sensitivity for particular end-points, if you have a product that doesn't cause that, it may very well be inappropriate to use a factor of 10, and maybe seven or three would be appropriate. It may be that there are instances where a factor greater than 10 seems necessary.

    Mrs. Karen Kraft Sloan: For reasons of clarity, Madam Chair, we should be careful when we talk about a 10 times factor for children's health. We should be clear that it's a possibility that may exist, it's not necessarily going to be used in every situation.

    I also wanted to follow up on the question Mr. Lincoln was asking with regard to subparagraph 67(1)(z.4)(ii). I apologize if he received an answer, but I had to step out of the room briefly.

    It says, “if the Governor in Council is satisfied that the exempted products, persons or activities are sufficiently regulated under another Act”, this act won't apply. I'm just wondering if there are particular examples of products regulated by other acts of Parliament that would receive this exemption, if you've given us examples of that.

    Dr. Claire Franklin: The question was answered. There's a more detailed response that Mr. Stapleton gave. The products that would be exempt, would be products used for research.

    Basil, I don't know if you want to say anything.

    Mrs. Karen Kraft Sloan: I'm referring to subparagraph (ii), where they are regulated under another act.

    Dr. Claire Franklin: Hard surface disinfectants are regulated under the Food and Drugs Act.

    Mrs. Karen Kraft Sloan: I haven't read the act in great detail, but I'm wondering if there is a criterion identified within this act that specifies how the Governor in Council may be satisfied they are sufficiently regulated. Or is that at the discretion of the GIC?

º  (1645)  

    Mr. Basil Stapleton: The decision would have to be made, of course, on the basis of the objectives of this act, to ensure that a product within the definition of pest control product will not be used in the country unless the risks and value are acceptable. So before the Governor in Council could be satisfied that the same product is being adequately regulated under another statute, effectively, the same criteria would have to be met.

    The disinfectants were subject to two regulatory regimes, because they come within the definition of control product, but they also come within the definition of drug under the Food and Drugs Act. It 's not intended that there be undue regulation. Sufficient regulation, I guess, is what the objective is. The rationale would have to be explained in the RIAS that goes out for public consultation, why it is that in the case of disinfectants, for example, it was believed that the regulatory regime under the Food and Drugs Act was meeting the same objectives as under the Pest Control Products Act, and so there was no need really to continue regulating them under both statutes. So the explanation as to how the Governor in Council would come to that determination would in fact be published for public consultation before the actual regulation was adopted. And if the consultation brings forward sufficient evidence that the other regime is not adequate, that obviously will have an impact.

    Mrs. Karen Kraft Sloan: You haven't specified criteria for identifying “sufficiently regulated” in this act, and if it's not identified in this act, would you object to having it identified? You have just told me it has to do with the mandate of this particular act. Is it written in the provisions of this act that they'd have to adhere to the mandate of this act?

    Mr. Basil Stapleton: As a matter of law, the exercise of the regulation-making authority is not open-ended. Parliament gives the Governor in Council authority to make regulations to implement the regulatory regime of this act, and any use of that must be consistent with attaining the objectives of this act. That's not written into every one of the regulation-making authorities, but it's understood that Parliament does not intend that the Governor in Council can turn around and undo everything Parliament has done. If in fact there is an excessive jurisdiction, if regulations are adopted that would have the effect of undermining the attainment of these objectives, the legal basis, the vires, of that regulation would be in question.

    I know you're familiar with CEPA, and it's not unique to this statute that the Governor in Council is given authority to make regulations based on a determination as to whether something is being adequately addressed under another act. It appears in CEPA in the same way. And there are no criteria, as I recall, in CEPA either. It is a matter of determination, considering all the factors, as to whether indeed the Governor in Council can be reasonably satisfied.

    The Chair: Thank you, Mrs. Kraft Sloan.

    We'll go to Mr. Hilstrom now.

    Mr. Howard Hilstrom: Thank you, Madam Chairman.

    Madam Franklin, have you established performance standards for category A priority and standards for new registrations if Bill C-53 passes? Have you set those standards or not on how quickly you'll be able to do new registrations?

    Dr. Claire Franklin: We have the guidelines put forward in 1996 on the performance standard for the time for us to take a decision, and that's established for all the categories of submissions we have.

º  (1650)  

    Mr. Howard Hilstrom: So it's the same as today, and that's fine. I know you've got 2006 for the 400 existing ones.

    The proposed bill is selective in borrowing from the Food Quality Protection Act in operation in the U.S. since 1996, right? It never took the whole thing. How is it we didn't use this opportunity, with new legislation, to enable a full harmonization with the United States?

    Mr. Basil Stapleton: That's really a policy question, rather than a legal one, if I might say.

    Mr. Howard Hilstrom: Okay, that's an answer.

    Now we get into the presentation. You indicate that one of the scientific evaluations is going to be if the product has value. Is this efficacy--does it work? How is it you're so worried about that? I'm a farmer myself, and nobody will ever buy again something that doesn't work. Why would we spend time, when our timelines to get something registered are quite long, looking at how effective it is? Why would we do that?

    Dr. Claire Franklin: The point of doing the efficacy review is not specifically to say whether it works or not. It is very unlikely that a registrant would come forward with a product that didn't work, period. There are some that don't work nearly as well as they suggest, but they're really in the minority. With the efficacy review--and we see this on many occasions--we're looking for the lowest effective rate that can be put out. With many products, we actually have an application rate that's lower than the one the registrant came in with initially. That's a very important feature from the perspective of sustainability. It reduces the amount of chemical in the environment, it reduces the amount of chemical people are exposed to. In fact, it can reduce, in many instances, the maximum residue level that's allowed, because of that lower application rate.

    Mr. Howard Hilstrom: You repeat the experiment, then, I guess, to establish a new level.

    Dr. Claire Franklin: No, we don't repeat the experiment. These are data that are required, and they're supplied to us. The thing that's sometimes missed is that they're also required in the U.S. The U.S. doesn't review them, but the data are required. The U.S., in fact, as far as I'm aware, at least within OECD, is the only country that does not review the efficacy data.

    Mr. Howard Hilstrom: My last question deals with this toxicology. You warned me about this before, but it's not the exact question you think I'm going to ask, it's a bit different. In your presentation you're saying the studies are designed to provide three key pieces of information, the last one being the dose level at which there are no toxic effects. Then you go on to say that permissible levels of exposure in humans must be at least 100 times lower than this no-effect level. Speaking as a layman, when there's no effect, why would I try and go 100 times lower than no effect? You've got to explain that a little bit.

    I assume there is a good answer for that, but for children it's 1,000 times less. Are we not always going to be at that 1,000 times less? Why would we ever be at the 100 times, because there are children everywhere? I think the children, if you want to know the truth, are getting more toxic substances from these cars uptown here than they are from pesticides, but anyway....

    Dr. Claire Franklin: We're looking for a level that people would be exposed to that's lower than the no-effect level in animals, to take into account that we're extrapolating the data from animals. We want to make sure, in case we have any additional sensitivity in people. We have to be able to separate that. We've got a level in animals, and we must take into account that people are different. That's really where the hundredfold comes from.

º  (1655)  

    The Chair: Thank you.

    We'll go to Mr. Lincoln.

    Mr. Clifford Lincoln: Madam Chair, I wanted to come back to Mr. Stapleton's reply to my first question and Mrs. Kraft Sloan's about paragraph 67(1)(z.4). I must say, after listening to you twice, I'm more worried than I was before. I don't think saying it's in the old act, which is 33 years old, means it should be in the new act anyway. You referred to the fact that some products are risk-free or almost risk-free. So was DDT when it was first launched. It used to be risk-free too, until we found out it was deadly. So I look at this clause again, and I see so many loopholes that it's scary. Subparagraph 67(1)(z.4)(ii) says the Governor in Council can exempt if it's satisfied “that the purposes of this Act can be met without applying the provision”. Does that open the door to voluntary compliance, if the cabinet at one time says, we think the industry has produced a good plan there, so we'll agree to this provision, so the act doesn't have to apply, the regulation doesn't have to apply?

    Second, as you treat activities, surely, the power is so huge here that it could preclude a value assessment to harmonize with the U.S. on the basis that the U.S. doesn't do efficacy reviews, which was one of the points we brought up in our review. We were really worried about the difference between the U.S. and Canada. We were worried the PMRA might escape this by saying it wants to harmonize with the United States. It seems to me this clause is so wide open. It's very nice to say the Governor in Council has to work within the act and the objectives of the act--oh yes, we've seen that before.

    Why do we have such loopholes and such wide open clauses that permit a subjective appreciation of what other measures can be taken to escape the regulation on the part of industry, considering that we're dealing with lethal products? I find it just terrible that this clause is there and that it's not tightened, Mr. Stapleton.

    Dr. Claire Franklin: If I could just answer your concern regarding efficacy, in the joint review document it's very clearly stated that efficacy reviews will be done. They will be done by Canada. In fact, with the very first product we had through as a joint review, it ended up that the application rate was 50% lower than the one with which the company came in. Not only did Canada use that lower application rate, the U.S. used it as well. So there is not an intent that this would be utilized to exempt us from any requirement that we would have to establish the acceptability of a product. Very clearly, if there were aspects like that--and to the best of my knowledge, there aren't--that's the only area we do differ on.

    Mr. Clifford Lincoln: Yes, but those have been there for 20, 25 years, and the second one has been there for 33 years. So we have to make sure we don't leave loopholes that can be used by other people.

    Dr. Franklin, we suggested that there be a reference to the toxics management policy of the government. All it says is “shall give effect to government policy”. Why can't we just say toxics management policy and track one substances? Why, also, don't we make any reference to formulants, contaminants, as we suggested, instead of just plain ingredients?

    Ms. Geraldine Graham: With regard to the toxic substances management policy, it is given in the definition of government policy. The only reason we didn't put it in the provisions of the act is that we wanted to leave open the possibility there might be other such policies we would want to also take into account. The definition of government policy in clause 2 on page 5 means the toxic substances management policy. So everywhere you see that, you can make the assumption.

    As for formulants being included, the definition of pest control product is such that the formulants are included. It is the whole product we're talking about. We did discuss that quite thoroughly with the legislative drafters to make sure it was clear in the way we defined pest control product, as well as the way we defined health risk and environmental risk, that it was including evaluation of the risks posed by formulants.

»  (1700)  

    Mr. Clifford Lincoln: Why do you include a separate definition for active ingredient, then?

    Ms. Geraldine Graham: It's so that we can register the active ingredient as well as the end-use product, and that's what we do. They have separate registrations.

    The Chair: Thank you, Mr. Lincoln.

    Mr. Bigras.

[Translation]

    Mr. Bernard Bigras: Thank you, Madam Chair. As you know, a task force in Quebec looked at the whole issue of pesticide use, particularly in urban settings. One of its observations was this. A number of sectors came to this conclusion. I am thinking of sectors such as ornamentals or horticulture, where people said that they were ready to look at alternatives to certain products, except that they were very critical of the federal system for approving and regulating biopesticides, among other things. They were very critical of this approval system.

    When I read the preamble to the bill, one of the objectives is that:

the federal regulatory system be designed to minimize health and environmental risks posed by pest control products and to encourage the development and implementation of innovative, sustainable pest management strategies.

    Note the word “sustainable”.

    My question is this. To the extent that this legislation is supposed to regulate products used for the control of pests—In comparing Canada and the United states, you told us about pesticides approved last year, but what I want to know is how many biopesticides are approved in Canada as opposed to in the United States.

    Second, I would like to know whether you think that this legislation will result in faster approval of biopesticides, as a number of economic sectors in Quebec, for instance, are requesting.

[English]

    Dr. Claire Franklin: With regard to biopesticides, there have been a number of comments from Quebec on that. I really would like to set the record straight. To the best of my knowledge at this point, every single company in Canada that manufactures biopesticides has an application in with us. We spent a great deal of time going around and encouraging these smaller companies to bring these products forward. We've also established, as I indicated, a joint review program with the U.S. for microbials and pheromones, in an effort to encourage U.S. companies to actually make applications and bring their products into Canada. So we've been very active in encouraging and trying to get these kinds of products, because, from our perspective as well, they're important alternatives that will increase sustainability. There's no question that we don't have as many of these products in Canada as are registered in the U.S., and we are actively working, as I've indicated, to try to encourage companies to come forward. We do not have application fees for microbial products, also to encourage. There's only a very small amount that has to be paid for the label.

    So we've done a number of things to encourage these, and we are seeing more of them come in. We are very clearly interested in having companies come forward with these kinds of products.

[Translation]

    Mr. Bernard Bigras: You did not tell me how many, but is a ratio of 30 biopesticides approved in Canada compared to 150 in the United States right?

    Second, to reply to my question, will this bill speed up approval of biopesticides so that we can try to catch up with the United States?

»  (1705)  

[English]

    Dr. Claire Franklin: We have, according to one of my colleagues, 53 biopesticides in Canada. That's a fairly significant increase over the past couple of years. Will this bill help encourage that? We believe it will, because it allows us to work more closely with other countries, it enhances our capacity to work jointly with other countries, not only with the U.S., but with other OECD countries as well. So I think it will assist us in doing that.

[Translation]

    Mr. Bernard Bigras: Do you know how many biopesticides have been approved in the United States? Is the figure 150 right?

[English]

    Dr. Claire Franklin: It's approximately 170.

    The Chair: Thank you, Mr. Bigras.

    We'll go to Mr. Speller now.

    Mr. Bob Speller (Haldimand--Norfolk--Brant, Lib.): Thank you, Madam Chair, and thank you for coming forward today again, Dr. Franklin.

    My basic question is on minor use. I'm wondering why it's not defined in the act, why the principle of minor use isn't there. It's so important to what we do in our agricultural communities across the country. It would seem to me that this would be a good place for it.

    Dr. Claire Franklin: I'm going to ask Geraldine to answer this question.

    Ms. Geraldine Graham: The reason we didn't put it in is that we don't have the operational details about how submissions are reviewed, what different kinds of submissions there are, different streams of priority. We just haven't got into those kinds of operational details in the act. We're just setting out the legal framework for the elements they have to meet to get registered. Dealing with minor uses is part of how you administer the act, how you prioritize and handle your workload. That was really our reason.

    Mr. Bob Speller: I'm not sure I either understand or agree, but I think it should be there, since it is such an important aspect, so that you can give the assurance, at least, that it's understood.

    Dr. Claire Franklin: I would presume that's something that could be taken into consideration. It's just that we have not identified any registration types. That's really not a level of detail we put in. It is something that would be put in regulation, not only the type, but if there were particular conditions concerning that. That's not to say it's the only way it could be done, but that's the level of detail that has been included with regard to registration types.

    Mr. Bob Speller: Have you had an opportunity to look at the Prime MInister's task force report on future opportunities in agriculture? I'll make sure you get a copy. There are a few things in there on which I wouldn't mind having your response at a later time.

    The Chair: Thank you, Mr. Speller.

    Ms. Wasylycia-Leis.

    Ms. Judy Wasylycia-Leis: Thank you.

    Further to the question Bob Speller just asked about what's in or what's not included in the act, I think there's a lot of concern from all the different stakeholders about the role of the PMRA. We certainly heard quite a lot from the farmers the other day. A lot of frustration was expressed. We know from some of the activists in the health community that there are questions and uncertainties about how effective that part of the mandate of the PMRA is. Yet there is so little spelled out in the act to clarify roles, responsibilities, timelines, definitions. Bob mentioned one of them. Others have focused on definitions of cumulative effect, aggregate exposure, acceptable risk. There have been questions about why the PMRA is not defined in the legislation, why the act doesn't discuss things like endocrine disruptors, persistent organic pollutants, and so on.

    This is supposed to be pioneering legislation to replace a bill that's been around for 33 years. Why aren't we making sure that in this bill everything is covered, we're clear about the role and mandate of the PMRA, and we're very clear about definitions on every count?

»  (1710)  

    Dr. Claire Franklin: The balance between what's put in the act, what's put in regulation, and what's in policy and directives is a sort of continuum whereby that level of information is provided. Should there be more detail in the legislation? Should there be more in the regulation? That's a balance. We have tried to reflect the type of detail we see in other pieces of legislation within Canada. Could there be more? Some people would say yes. Should there be less? Others would say so. That really is a balance we have to come to grips with.

    With regard to mandate for the agency, as was pointed out earlier, the agency doesn't have a separate mandate from that of the minister. We are an organization that works within the department. The minister's mandate is the mandate we carry out on her behalf. There is not a specific, separate mandate. It would be, as I understand it, somewhat contradictory to have a separate mandate for us in a piece of legislation for which, in fact, the minister has responsibility.

    Ms. Judy Wasylycia-Leis: One question that has been raised very recently about this bill is on what appears to be a dual mandate of the PMRA. I guess the concern is that it would be nice to have it addressed in legislation, so we can be clear and avoid any possible conflict of interest. It's often compared to the CFIA and the problems it's facing in being responsible for working with the agricultural sector and the food industry, while being the overseer of health and safety. The same concern has been registered with the PMRA. I'm wondering if it wouldn't make sense for this act to be absolutely clear on the roles, with a clear understanding about who's responsible for what.

    Dr. Claire Franklin: I believe it is clear. The mandate for the minister in registering or regulating pesticides is that health and environment are the bases. That's not different from the previous legislation. It is criminal law legislation, and health and environment are the focal points for that. So I don't think it's unclear. I think that is the way in which the legislation is currently constructed, as it was with the previous legislation.

    Ms. Judy Wasylycia-Leis: Let me turn back to my earlier question on product review. Can you tell us, from the reviews that have been done, how many products ended up being withdrawn from the market or pulled off the shelves or having warnings issued in the last several years?

    Dr. Claire Franklin: That information I would have to provide. We have probably had a couple of actives where there have been sufficient concerns and we have not registered the product. In many cases modifications are made to the way in which the registrant has submitted the product. They may have submitted it for use in such a way that the exposure would be too high, so that there is a reduction in the amount that can be used, or there can only be two applications, not three. There may be some uses that aren't allowed because the data don't support the safety of those particular uses. It's rare that a company would come to a registration agency with a product that would fail totally. They've generally spent a lot of time at this. They're very aware of what the benchmarks are. So that is not something that happens frequently. But there are a number of modifications that do reduce the exposure and the environmental and health risks that might be attendant on the product.

    There are some that the registrants may withdraw. If we go back and ask for additional information, feeling that a particular point needs clarification or we don't have enough information, there are some products or some uses where a registrant may determine that they're not interested in providing the additional information.

»  (1715)  

    The Chair: Thank you, Ms. Wasylycia-Leis.

    Mr. Hilstrom.

    Mr. Howard Hilstrom: Thank you.

    Will the PMRA actually lower the effectiveness of a product to the point where it's useless?

    Dr. Claire Franklin: No.

    Mr. Howard Hilstrom: There was strychnine for gophers. They put forward a product that did not work, and farmers used it. Of course, that issue's still boiling. If you want to answer that, that's fine.

    Dr. Claire Franklin: I would like to answer that, because the decision was taken before PMRA was formed. It was done on the basis that the concentrate the farmers were to use to make the diluted bait was being misused, there were problems with it. The intent was that the bait, at the level at which the farmers mixed it, was the one that was to be used. That was done long before the agency was in existence, but we are working very actively to try to find solutions for that very real problem. There's no question that it's a very real problem.

    Mr. Howard Hilstrom: I'm not bringing this up in any mean-spirited way. It's just that it is important, as you say.

    I note from your presentation that your staff put this together without mentioning the word animals in any place. It was good of you to explain to me, a layman, that the tests done to determine toxic effect are done on animals. We're working on some legislation in the House involving the capacity of animals to feel pain. Medical researchers are very concerned that they're not going to be able to use animals for these tests in the future. Can agencies do tests without the use of animals to determine these no-effect levels?

    Dr. Claire Franklin: There's been a very active movement for many years to reduce the number of animals in tests. There are some end-points that can be examined using in vitro cells, so that you don't have to use animals for that, but it is a significant issue. All animal studies are done under very strict controls. The laboratory that's doing them really does have to comply with standards for that.

    Mr. Howard Hilstrom: The committee is studying this whole issue of possibly in vitro and human life forms being the test subjects. That's a separate issue the health committee is dealing with.

    Let's talk about the protection of intellectual property rights. The bill in its current form, according to the plant science industry, does not get the balance right between the desire for information of Canadians generally and the intellectual property rights of the industry. The example used is that this act will replace provisions in the Access to Information Act that previously safeguarded the plant science industry. This new act also narrows the definition of confidential business information and removes the need for consent of the registrant to release documentation for public consultation. Do you feel that you've got the right balance in protecting the intellectual property rights, which is almost like the Charter of Rights? We've got rights and we should have them protected, even though the majority may want something else. Is that not the situation here? Is the industry protected, yes or no?

    Dr. Claire Franklin: We believe the industry is protected.

    Mr. Howard Hilstrom: Could we say it in the legislation? Could we bring an amendment that you would support? I don't know if you actually have to support it, but the other members might support it. Would you object to having a strengthening of protection of intellectual property rights? Is there any objection to strengthening that?

    Dr. Claire Franklin: If your intent would be to restrict public access to the test data upon which we base our decisions, I think this would not be the spirit the multi-stakeholder review asked us to endorse. In fact, the multi-stakeholder review that was put out in 1990 suggested we go even further and provide hard copy of the test data to the public. In an effort to prevent misuse of that information, we have indicated that the confidential test data a company provides to us would only be made available to the public in reading rooms, so that they would not be able to take away hard copies. I would point out that in the U.S. the public can get hard copies of the very same data.

»  (1720)  

    Mr. Howard Hilstrom: There seems to be better protection in the United States for business information. Here again, our act isn't aligned very closely with the U.S. act to provide that same protection. Do you disagree with that statement?

    Dr. Claire Franklin: No. We do not have the authority to do it in exactly the same way the U.S. has done it. Their act is under a very different constitutional authority, and they have different pieces of legislation. What we've done is allow access to information, while still protecting the utilization of that information. In fact, the way we have put this in the legislation is very similar to the way it's done in the U.K.

    Mr. Howard Hilstrom: What about including the right to be consulted about disclosure before full release? What's wrong with that?

    Dr. Claire Franklin: With reviews we do as an agency, I currently have to ask the industry if I can release the information.

    Mr. Howard Hilstrom: So the public doesn't have access.

    Dr. Claire Franklin: For the new products, the way we're doing it now, companies will allow us to do that, but I don't think we, as a regulatory agency, should need to have industry's permission before we're able to provide information on a review that we've done.

    Mr. Howard Hilstrom: That's intellectual property, though.

    Dr. Claire Franklin: As I understand it, if we're allowing the information to be made available in a reading room, the company will be informed that this is being done.

    Mr. Howard Hilstrom: Even if you don't give me a hard copy, if I sit down there, I'm scientifically inclined, I jot down the formula, and I take that out of there, either in my head--some people can remember a lot of stuff--or on paper, what's the difference?

    Dr. Claire Franklin: Confidential business information, the formula for the product and the method of production, would not be made available. What would be made available to the public would be the test data, the animal data upon which we would be doing the assessment of the no-effect level and the acceptability of that particular product. There's a very narrow definition of confidential business information. That would be the crown jewels, and it would not be our intent that this information be made available. But we feel it is quite appropriate for Canadians to be able to see the test data the public are allowed to get access to in other countries .

    The Chair: Thank you, Mr. Hilstrom.

    Mr. Lincoln.

    Mr. Clifford Lincoln: To come back to confidential business information, Dr. Franklin, a person designates what is confidential business information under the act. Is the definition not so broad that people can circumscribe business information by saying everything is business information? How do you prove to me from the act that a person who says this is confidential business information does not have a case to make, as the act gives such a restricted provision that it's almost impossible to get to it?

    Ms. Geraldine Graham: With paragraphs 43(4)(a), (b), and (c) and 43(5)(b), they can't designate anything as being CBI unless it fits one of those categories. When the minister looks at what they've designated, if it does not fit one of those categories, that designation is taken away.

    Mr. Clifford Lincoln: Yes, but when you publish the register under subclause 42(1), the only information provided is the active ingredient of the product, which is, in your definition, a component of a product.

    Ms. Geraldine Graham: That is for applications where it's not yet registered. Once the product is registered, all the conditions of registration are there, all the test data, and all the information. The CBI is there, but it's the CBI the public is not given access to that has a very narrow definition.

»  (1725)  

    The Chair: Thank you, Mr. Lincoln.

    I just have one quick question. It was pointed out to us yesterday that when the EPA ruled that certain products be withdrawn from the market, the companies involved decided to sell them by export to third world countries. I'm wondering if we have anything in our act to prevent that. If it's not good for the health of Canadians, I think we should be responsible on the international scene too. I'm wondering if it's in there, and, if it's not, whether you would consider preparing an amendment to that effect.

    Ms. Geraldine Graham: We do have provisions to implement the prior informed consent convention, which is what deals with that issue, in clauses 33 and 34. You would not be able to export a product on the so-called pick list unless the importing country had given their consent. That's how countries have decided to deal with that issue.

    The Chair: Did you want to respond, Dr. Franklin?

    Dr. Claire Franklin: f it's the pesticide they would be exporting, they would have to have a registration in Canada. They could not export it if it weren't registered.

    The Chair: What about the case of one that was registered and then deregistered by authorities such as yourselves, and they quickly took what they had stored up and got it on ships?

    Dr. Claire Franklin: You're concerned that a company manufacturing it here, when we de-register it, would sell it to a developing country?

    The Chair: Yes. That's what happened, apparently.

    Dr. Claire Franklin: I think, as Geraldine has pointed out, with the provisions of PICC, the intention would be that they not have the authority to do that.

    The Chair: It seems to me that the highly developed countries who want to unload toxic substances onto countries that maybe don't have the same scientific expertise might get permission from a country that is desperate for some pesticide. Do we not have more responsibility than that?

    Ms. Geraldine Graham: The convention was approved by a lot of different countries, including developing countries. It was developed by WHO and FAO. If we cancel a product here, we have to notify the PICC secretariat. Information about why we took the action has to be distributed to all the parties to the convention, so they have the information on which they can decide if they want to receive the product.

    The Chair: Thank you very much.

    Thank you to our witnesses, Mr. Stapleton, Dr. Franklin, Ms. Graham, and thank you to my colleagues.

    Colleagues, we had 18 questioners today. If we do that tomorrow, we won't have time to review the witness list, which I said I'd save 10 minutes for, but I'm beginning to feel we may need 20 tomorrow. I'll ask you to keep your questions tomorrow rather succinct, so we finish 20 minutes before the end and can focus on the process of how we're going to review this bill.

    Thank you very much, ladies and gentlemen.

    This meeting is adjourned.