Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 30, Evidence of November 16, 2005
OTTAWA, Wednesday, November 16, 2005
The Standing Senate Committee on Social Affairs, Science and Technology, to which was referred Bill C-28, to amend the Food and Drugs Act, met this day at 1:05 p.m. to give consideration to the bill.
Senator Michael Kirby (Chairman) in the chair.
[English]
The Chairman: Honourable senators, with us today is the Honourable Robert Thibault, Parliamentary Secretary to the Minister of Health, together with department officials Ms. Karen Dodds, Executive Director, Pest Management Regulatory Agency; Mr. Paul Mayers, Acting Associate Director General, Food Directorate; and Ms. Claudette Dalpé, Associate Director, Bureau of Food Regulatory, International and Interagency Affairs.
We will begin with a brief opening statement from Mr. Thibault and then we will turn to questions from the committee.
Hon. Robert Thibault, P.C., M.P., Parliamentary Secretary to the Minister of Health: First, I would like to express our gratitude to the committee for being here to advance this bill when the Senate is not sitting. We appreciate it greatly.
I am pleased to have the opportunity to speak to you about Bill C-28 which proposes two amendments to the Food and Drugs Act. Health Canada is proposing these amendments for two purposes: to address concerns expressed by the Standing Joint Committee of the Senate and the House of Commons for the Scrutiny of Regulations regarding an administrative process for issuance of interim marketing authorizations established by the regulations; and to ensure that the very important and beneficial notice of interim marketing authorization mechanisms can continue to be used by Health Canada to accelerate the introduction of some new and safe food products to Canadian consumers.
This bill maintains the most important element of the protection of public health that is already recognized in the current interim marketing authorization mechanism in the Food and Drug Regulations.
The first amendment would provide the Minister of Health with the authority to issue an interim marketing authorization, allowing the sale of some food products for which scientific assessment has established that the consumption of these products would not be harmful to consumers, pending completion of the full regulatory process to amend the regulations authorizing market entry.
[Translation]
The second amendment would exempt a food containing residues of pesticides that are at or below the maximum residue limit specified by the Minister of Health, under the new Pest Control Products Act, from the adulteration provisions of the Food and Drugs Act. Maximum residue limits are set following a scientific assessment which establishes that there is a reasonable certainty that no harm to consumers will result from the consumption of foods containing these residues of pest control products at the maximum residue limits established.
[English]
In regard to concerns originally raised by the Standing Joint Committee of the Senate and the House of Commons for the Scrutiny of Regulations, the committee discussed this bill at its meeting of February 3, 2005, and concluded that it would address its concerns about the issuance of interim marketing authorizations.
Interim marketing authorizations would have to be published in the government notices portion of the Canada Gazette, Part I, so that all interested parties would be aware of it and be able to make comments.
This bill will ensure the continued availability of a beneficial mechanism under the Food and Drug Regulations to ensure Canadian consumers have timely access to new and safe products. In addition, I am convinced that this bill is a smart measure and contains the basic principles that have been suggested by the external advisory committee on smart regulations for a new regulatory policy. This bill is a sound initiative to move to smarter ways of regulating, and I believe it deserves your support.
I would like to introduce the Health Canada officials who have joined me today to speak about this bill. Mr. Paul Mayers will address the food safety aspects of the bill, while Ms. Karen Dodds will speak to the aspects of Bill C-28 that relate to pest control products.
Paul Mayers, Acting Associate Director General, Food Directorate, Health Products and Food Branch, Health Canada: Let me provide a brief overview of one aspect of the bill, dealing with the issue of the food safety elements. I will focus my comments in the context of how this bill fits with the government's Smart Regulation Initiative.
The advice received from the External Advisory Committee on Smart Regulations provided an external perspective and expert advice on how the federal government could redesign its regulatory approach in the 21st century. Annex III of the report is particularly relevant to Bill C-28 as it identifies several key principles for a new regulatory policy. Some of these principles are effectiveness, cost efficiency, timeliness, and accountability and performance.
Bill C-28 is a good example in respect of these principles in that it allows new and safe food products into the marketplace as quickly as possible after the safety evaluation of those products has been completed to give consumers access to these foods. Allowing a food to be sold to consumers as soon as the government has been convinced of its safety — based on an assessment of the latest scientific knowledge — provides for maximum effectiveness in the regulatory system and offers a greater diversity and availability of products to consumers, while responding to the changing business environment of the food industry.
Interim marketing authorizations would not be a means to bypass the normal processes in place within Health Canada for the conduct of a safety review of a new food additive or veterinary drug to protect the health of Canadian consumers. Those substances, that is, new products, will still go through the normal regulatory process amending the regulations to provide for their use or presence in food sold in Canada.
By contrast, interim marketing authorizations could only be used for food additives and veterinary drugs that have already been subjected to that thorough safety assessment and are already listed in the regulations.
A second safety assessment would be conducted upon receipt of a request to expand the permitted foods, in which one of the substances might be used or might be present, and Health Canada would only give consideration to issuing interim marketing authorization if it were concluded the sale of food products with either a higher level of use or a new food product containing the substance in question would not pose a hazard to the health of the consumer. In addition, by issuing the authorizations, the Minister of Health could inform consumers and the industry of the availabilities of foods sooner rather than waiting until the full regulatory amendment process has been completed. This can be up to two years post the safety evaluation process. As soon as that evaluation is complete, and the government is convinced that the food is safe, the information would be shared with consumers and industry alike, and the government would indicate that the foods could then be marketed.
While consumers and industry are benefiting from that authorization, the formal process would be undertaken to amend the Food and Drug Regulations to reflect the expanded regulatory requirements accordingly.
Bill C-28 will also establish a performance standard for regulators. When an interim marketing authorization is issued, it will have a finite lifetime of only two years. After that time it would become invalid. Regulatory amendments to the Food and Drug Regulations to provide for the sale of the food under the authorization must, therefore, come into force before the authorization expires. Clearly, having been permitted products into the marketplace, consumers and the food industry will not be satisfied if these deadlines are not met.
The second aspect of the bill, as the Parliamentary Secretary to the Minister of Health has noted, relates to pest control products and my colleague Dr. Karen Dodds will address this aspect of the bill.
Karen Dodds, Executive Director, Pest Management Regulatory Agency, Health Canada: I would like to address the second proposed amendment. This amendment exempts the food containing the residue of a pest control product at or below the maximum residue limit specified by the Minister of Health under the new Pest Control Products Act from the adulteration provisions of the Food and Drugs Act.
[Translation]
I want to emphasize that this would not affect the scientific assessment process for determining the Maximum Residue Limits (MRL), nor the safety of those limits.
[English]
Before registering a pesticide in Canada or before establishing the maximum residue limit, or MRL, scientists at PMRA must conclude that there are no unacceptable human health risks. In establishing the MRLs, scientists review toxicological data and residue data then complete a dietary risk assessment. The toxicological review is extensive and includes chronic, long-term studies, reproductive and developmental studies to determine any potential impact on reproduction and the healthy development of the fetus, carcinogenicity studies, that is, whether the product can cause cancer, and others before establishing the maximum residue limit. A dose is established that causes no adverse effect and then safety factors are included. The risk assessment must show that the pesticide residue can be consumed daily for a lifetime with no adverse effects in humans and must consider the vulnerability of infants, toddlers and children.
The proposed amendment to the Food and Drugs Act would change only what happens administratively to legally establish an MRL after the scientists have determined what the MRL should be. Currently, they need to be established in regulation under the Food and Drugs Act. The IMA process allows use of pesticides on food crops while the regulations are being changed. The proposed amendment would allow the MRLs to be specified under the new Pest Control Products Act with appropriate consultations without the need for regulatory change. It would also allow for faster revocation of an MRL if new scientific studies demonstrated unacceptable risks to human health.
[Translation]
The current IMA process allows earlier use of approved pesticides on food crops in Canada. The proposed amendment also achieves this end. This allows Canadian farmers quicker access to newer products, typically already available to their US counterparts.
[English]
The IMA process has allowed the sale in Canada of a variety of fruits and vegetables, including lettuce, tomatoes, Chinese broccoli, bok choy, cabbage, leeks and many others, approximately 16 months before the regulatory process is finished. Thus, the proposed amendment maintains safety standards while facilitating earlier access to approved products.
The Chairman: Why does it take, typically, approximately 16 months longer for us to complete the regulatory process than the Americans?
Ms. Dodds: We do not begin working on a proposed regulatory amendment until the scientific evaluation is finished, otherwise it would be wasted. We have to prepare a draft regulation and the impact analysis statement and then go through the government approvals before going to the committee of Treasury Board ministers for approval for prepublication in the Canada Gazette, Part I.
Comment periods in Canada Gazette, Part I can vary between 30 and 75 days, after which time you study the comments and revise all the packages. Typically speaking, we receive no comments after publication in Part I, and we simply make the revisions to show it is going through in Part II, but all the same administrative processes have to happen. The drafters of the Department of Justice have to review and blue stamp regulations, and they have to go through the minister's office, to Treasury Board ministers, for review and approval for publication in Part II. It is not until it is published in Part II that it is adopted as regulation.
The Chairman: That was a terrific description of the Canadian process, but it is not what I was asking about. You say that that typically takes 16 months longer here than in the U.S. Exactly the same is true in regard to drug approval. We are the slowest in the Western world, which is hardly something of which to be proud. My question is: What is it about the approval process in Canada that cannot be efficient? Sixteen months is a long time in the competitive marketplace.
Ms. Dodds: The 16 months is usually the lapsed time between our finishing the scientific evaluation and the completion of the regulatory process. It does not highlight the difference between the timelines in U.S. and Canada.
The Chairman: You said the products can be used in the U.S. substantially before they can be used in Canada. I want to understand the time difference.
Ms. Dodds: With respect to the elapsed time for scientific review, in the pest control products area, we are pretty much on par with the United States Environmental Protection Agency now. A major barrier occurs when a company producing a pesticide makes a submission. Presently, Health Canada's Pest Management Regulatory Agency and the EPA's agency do a number of joint reviews which is, what we consider, optimal. Both agencies receive the same submission at the same time. We agree to do the review together and come to a decision at the same time.
The Chairman: Do you finish the process at the same time?
Ms. Dodds: We do not if MRLs need to be established, because then we are required to go through the regulatory route and they are not. More often, products are not brought forward under joint review and we may receive a submission two or three years after the United States has received a submission.
The Chairman: If the U.S. does not require MRLs why do we need them?
Ms. Dodds: They require MRLs but they are not done through a regulatory process.
The Chairman: They are more efficient.
Ms. Dodds: They have a process similar to the one suggested here.
Senator Keon: I have a supplementary. Are you dependent on cost recovery for the approval process?
Ms. Dodds: The Pest Management Regulatory Agency has a cost recovery regime. Currently, we cover approximately 20 per cent of our costs, and the fee depends on the kind of review we undertake.
Senator Keon: Is this an impediment to your work? If you had all the government funding that you required rather than the need to recover costs, would your process be more efficient? I know that this is an issue at Health Canada.
Ms. Dodds: The 20 per cent that I mentioned is of our total budget. We receive base appropriations from government for doing our work. We are in the stream of doing an evaluation of our cost recovery regime, which was a requirement of Treasury Board when our cost recovery regime was established. We will come forward with our stakeholders at some time soon with recommendations for change.
Senator Keon: It has been my impression that since this regime was established at Health Canada it has slowed them down. Is it slowing you down?
Ms. Dodds: I do not believe it slows us down, but it has an effect on how we work.
Senator Keon: This proposed legislation is a giant step forward in principle. I note the tremendous concerns arising about the transmission of many kinds of viruses, prions, drugs, chemicals, et cetera, through the meat, poultry and fish cycles. Is this of concern to you or do you think you have all the relevant bases covered in this proposed legislation?
Mr. Mayers: Certainly, this legislative proposal would not address the issue of regulatory coverage of the entire food continuum. Of tremendous interest are animal diseases that have impacts on humans. Our recent experience with BSE is a notable example. Our human health protection controls often need to reach back in that continuum to the level of production or farther. This fact is well recognized. The agricultural policy framework announced by the government three years ago provided an opportunity to take that food continuum approach to risk management. That was absolutely credited within the health community as an opportunity to look at interventions early enough to have an effect, whether we are talking about pathogens introduced to animal production that later caused disease in humans or some scenario.
Bill C-28 does not touch on any of those aspects because it deals with only a small part of the regulatory responsibility — the part that is related to pre-market authority to address food additives, veterinary drugs, the addition of nutrients to foods and pest control products. That constitutes a tiny portion of the complete regulatory responsibility, none of which touches in a significant way on the issue of managing across the entire continuum. Senator, your point is valid and important but, unfortunately, this bill does not address that issue specifically.
Mr. Thibault: The simplest way to describe it is to say that none of that is addressed in Bill C-28. It does not speak to which products could be approved or what the maximum limits could be. Rather, the bill addresses how quickly they could be marketed after the approval process, while the regulations that support the legislation are being drafted. Nothing else would change. The criterion for approval would be neither reduced nor changed in any way.
Senator Keon: In my opinion, this proposed legislation is beneficial because it would accelerate the process and put the responsibility where it should be — with the deputy minister. However, are you not concerned that perhaps the minister is being hung out slightly? Certainly, there can be a cross-over of some of these contaminants into the food chain from the areas that I suggested.
Ms. Dodds: Perhaps I might offer some comments. There is a big difference in where this touches on the regulatory responsibility. All of these food additives, veterinary drugs and pest control products are deliberately used and so we can control their addition to the food chain. Contaminants that enter the food chain through a different process are much more difficult to control. For pest control products, we set maximum residue limits in animal tissues when the animal is consuming a crop that has been treated with a pesticide. We have the authority to examine the consequences in different parts of the food chain when there is a deliberate use of something at one stage in the food chain, and so it is much easier to regulate those uses as compared to contaminants that are inadvertently present in the food supply.
Senator Mercer: I thought I knew what we were talking about and how the bill would help, having studied it in some detail. However, I have become confused after some of the questions asked by Senator Keon and the chairman with respect to timing. It was my understanding that this amendment would help to speed up the process. For the benefit of all, perhaps you could give us one or two practical examples of how it is anticipated that these amendments would have a positive effect on Canadian consumers and producers?
Mr. Mayers: I will speak to food additives and to nutrient additions to food. We depend on food additives to provide protection in terms of the shelf-life of a product. When a food additive is added to a food to allow that food to have an appropriate shelf-life, consumers can be assured that the food product will remain consumable over a reasonable period of time so that they are able to purchase, store, prepare and consume it in a reasonable time frame. Those products are subject to pre-market review.
Innovation in that area occurs routinely whereby, when a product is developed, we go through the process of safety evaluation to demonstrate that the product is safe to use. Nonetheless, in the current context, that product cannot enter the marketplace until a regulatory amendment is undertaken to list it in the tables to division 16 of the regulations.
Using this IMA, the interim marketing authorization opportunity, at the conclusion of that safety assessment, having demonstrated the safety of the product, that product can then move into the marketplace. Product developers will have a new option for protecting their product. Consumers will have a new option in terms of assuring the shelf life of the food they have chosen, and that product will be available to them more than 18 months in advance of when they might otherwise have that product if we were constrained, in the absence of this interim marketing authorization, to the time of listing following a Part II publication.
The window of efficiency gained is over 18 months of earlier marketing of the product. The same is true for the addition of nutrients to a food. If we think about a fortified food product and the relevance that that fortified food product might have in addressing wider choice for the nutrients that we require through our foods, the same is true. We would reduce the period between completing the demonstration of the safety of the product and its availability in the marketplace.
In our view, those are important opportunities that are presented to consumers by having earlier access. As to the difference between Canada and the U.S., when consumers become aware of the availability of a fortified product in the U.S. that is not available in the Canadian marketplace, they often ask why they can buy the product in the U.S. but not in Canada. It may simply be that we are in that process between concluding the demonstration of safety and having the regulatory listing in regulations that authorizes the market entry.
All this bill does is bridge that period so that products demonstrated to be safe can legitimately be in the marketplace while we conclude the listing process. It is an administrative process, but it is an important one because it is regulatory, and, while that is being concluded, the interim marketing authorization provides the mechanism to bridge that period.
Ms. Dodds: We have a list of specific examples of pesticides given IMAs where MRLs are being established for a number of crops. Invariably it takes at least one growing season before it comes through in Canada Gazette Part II. Oftentimes it is two growing seasons before it becomes available.
One of the complicating issues could be that currently we are using IMAs. The Standing Joint Committee of the Senate and the House of Commons for the Scrutiny of Regulations raised the concern about it being beyond the minister's authority and that committee now has the authority to revoke a regulation if they do not think it is appropriate. We are in danger of losing the ability to issue IMAs.
The issuance of an IMA makes it absolutely clear that the minister has the authority. We can maintain this administrative procedure and get things out there earlier.
For pesticides, the second amendment is consistent with parliament's decision as reflected in the new Pest Control Products Act. When that bill was given Royal Assent a couple of years ago, it was clear that the minister would be allowed to establish maximum residue limits under the Pest Control Products Act. However, there was not a consequential amendment to the Food and Drugs Act that you would not also have to establish them in regulations.
Therefore, there was consultation on the pesticide MRLs, and this second amendment would close that gap by amending the Food and Drugs Act.
Senator Mercer: In reality, the amendments before us are not lengthening the process. They are actually shortening the process.
Ms. Dodds: Yes.
Senator Mercer: It goes to Senator Kirby's question about why it takes so long to approve products in Canada. This actually addresses part of that issue. We are making progress.
Mr. Thibault: I do not know that you can say it changes the process. It permits these products to be on the market while the process continues. We still go through the Gazette Canada and have public input. That process will continue, but the product can be on the market while the process continues.
The Chairman: You have saved me a question. Since the process is already going on, I wondered why we were changing the law. The reality is that there is debate about whether what we are now doing by regulation can properly be done by regulation. This has now been clarified.
Senator Fairbairn: I am not thoroughly familiar with the current process. However, in reading your material, I gather that what we are talking about today is exclusive movement on the process within Canada.
You refer to the fact that it will allow Canadian farmers quicker access to newer products typically already available to their United States counterparts.
I gather we are on the same page as is the United States in the kind of assessments they make and the authorizations that they give. That is bringing the two of us together.
What about other countries? The world is so small now when dealing with trading issues. Do all of the food products that come in from other countries, up to the same standards as we have in the United States and Canada?
Ms. Dodds: I can certainly address it from the viewpoint of pesticides.
As I said, we work closely with the U.S. Environmental Protection Agency, which is responsible for regulating pesticides in the United States. We undertake joint reviews at times where we are reviewing the same pesticide at the same time and we come to the same decision.
We, under NAFTA, have the technical working group on pesticides and this past May we agreed to the same process for establishing the maximum residue limit, once the safety assessment has been done, to determine some of the specifics.
Currently, in Canada under the Food and Drugs Act — and if the proposed amendment discussed today goes through in future it will be under the Pest Control Products Act — the MRLs do not differentiate between a product grown in Canada and product grown abroad. All food products sold in Canada must meet those MRLs, whether they have been grown domestically or imported.
These MRLs can become a trade barrier if different regulatory authorities have set different MRLs. Our work with NAFTA to tries to address any trade differences, while protecting our health and environmental standards.
We also work with other OECD on these issues, and we are involved in Codex. Presently, MRLs can cause trade barriers because they do relate to concerns about human health. Codex is a foundation that you look to when dealing with human health concerns.
Senator Fairbairn: This question occurred to me inasmuch as the trading world is small and products can easily and quickly cross borders. Do countries have to achieve an international standard or are standards drawn up country by country?
Senator LeBreton: Under our regulations in this country, are people who sell products obliged to identify the source of the products? Often grocery stores have signs to inform their customers of where a product was produced, such as Chile or Mexico. I think people do sometimes make their purchasing decisions based on their perception of pest control products in some countries that they may feel are not as rigid as, perhaps, the United States or other countries. How would you respond to that?
Ms. Dodds: I will start by addressing maximum residue limits that relate to pesticides. MRLs do not differentiate between whether a product is grown in Canada or imported into Canada. The Canadian Food Inspection Agency is responsible for enforcing all of the regulations respecting food production under the Food and Drugs Act. The agency is responsible for ensuring that MRLs are applied to any foods sold in Canada. The agency has an annual program of monitoring, sampling, testing of imported and domestic foods for compliance with MRLs.
We certainly will have input into the development of their program. They will ask us whether there have been results that have caused concerns or if we have concerns that a country might be using pesticides that are not approved in Canada or that may pose a health concern. We have input into their annual program. Perhaps Mr. Mayers can respond to the point about country of origin.
Mr. Mayers: The country of origin labelling issue is one that falls into a similar frame. The Canadian Food Inspection Agency has the responsibility for labelling policy that extends beyond health and safety provisions, as it relates to labelling.
The issues around country of origin labelling are not consistent across all product types. I would not wish to hazard a guess at their labelling policy in that regard. Certainly, you do see, for certain products, origin identification, but there is no blanket coverage.
Senator LeBreton: Is there a potential for that, though? A product that comes to mind is DDT. Long after DDT was banned in Canada, it was still being used in Mexico, for instance. Is there a chance that things fall between the cracks between the agencies of Health Canada and the Food Inspection Agency on products, especially those that involve pest control chemicals? Is there a danger that, somehow or other, a product could get into Canada and be in the marketplace while you are still working on regulations? Could we be eating a product that might contain some dangerous chemical?
Ms. Dodds: Usually we speak of these proposed amendments as speeding up access. I did note in my opening comments, however, that they can also allow us to take off an MRL that we have decided is no longer appropriate.
In the example of a product such as DDT, where the registration was not continued in Canada because of concerns, we would certainly work with the agency so that they would understand that a pesticide has been deregistered because of concerns, not simply because, for example, it is no longer being supported by the registrant or farmers are not using it. We would want them to identify those products and target them.
In our input into the development of their program, those are the kinds of considerations that we provide to the CFIA.
Senator LeBreton: Can you catch it, then?
Ms. Dodds: For the sampling and monitoring program, none of these things is without risk or vulnerability. It is important for us to know what pesticides are of concern and on what products they are being used. The UN, under the World Health Organization and the Food and Agriculture Organization, has a joint program to look at pesticides. That is not so much in a harmonization mode as to help some of the developing countries understand and to some support to them so that they do not need to have all the infrastructure that the developed countries have to do the scientific review, and for them to be able to just pick up where we have left off and put that into place in their own countries.
Mr. Thibault: As a practical example, I am working with a food producer in my area that produces cheese. He needs 20 per cent of dried goat's milk for the feta cheese he produces. He has difficulty finding that product within Canada. It is under quota restrictions for importation as a dairy product. He is now dealing with a potential exporter. However, for him to get a permit to bring it to Canada — because the exporter was not known to Canada and that country was not known for exporting that product — then it must go through CFIA for extended examination to see if that product meets the Canadian requirements for importation. Specifically, the concern is the one raised by Senator Keon about disease that can be transmitted through proteins.
The Chairman: Ms. Dodds, when you do a joint study with the U.S. environmental agency, does that mean that it is one scientific study and the identical results go to both government agencies and both government agencies agree on the interpretation? Is that essentially what happens?
Ms. Dodds: That might be the simplest form of describing it. In general, upwards of 240 studies are required for either the United States or Canada to register a new active ingredient. It is typically about 10 years in development, from discovery phase through to having all of the data ready to submit to an agency.
In our collaborative work with the U.S. EPA, we have come to the point where the fullest form of data is harmonized, so that what each agency might ask for is harmonized. In our joint reviews, we have been working towards being able to segregate so that they will, say, consider studies one through five and we look at studies six through 10. Then we draw conclusions. To build confidence on each side, at the next stages we may both examine studies one through five, come to conclusions, and then compare notes. Wherever possible we try to make the same decision. There are various policies and criteria in the two countries. Support involves coming to the same decision. There are many different steps involved when you are looking at toxicological studies, for example. We are working towards shared tasks rather than both of us reviewing the same thing. Often, we both conduct the reviews and then we come together and say that we share the same perspective. When we publish our annual performance reports, more and more now we do include how many decisions we have made under joint review. I did not bring that information with me.
The Chairman: The answer is that it is increasing, presumably. Is that correct?
Ms. Dodds: Absolutely.
The Chairman: I asked the question because this committee, for however along we have been looking at health care issues, has been boggled by the fact that the same drug studies are done in all major OECD countries, which is a colossal waste of both time and money. With respect to pesticides, we have independent government decisions, but you work together. I wish other parts of your department could function in the same way with respect to drugs. This simply establishes that what we have been pushing for is doable.
Ms. Dodds: I would clarify by saying that in some areas there is a requirement for unique Canadian data. For example, when making an environmental assessment, we consider the impact on species based on the Species at Risk Act. The United States does not have the same kind of legislation.
The Chairman: The best we know, Canadians and Americans share similar concerns regarding the human body. One would hope that, therefore, we can avoid duplication.
One problem we have is that some drugs are available in the U.S., Britain and other major EOCD countries years before they are available here. That struck us as nonsensical, frankly. It is interesting that the kind of cooperation we have argued for on the drug side seems to work on your side.
Mr. Thibault: I could add that that is not lost on the government. That is why we embarked on the smart regulations process and the external advisory board, namely, because we recognize that is a problem. We have invested about $150 million to speed up the process, and $150 million to ensure more transparency. Usually transparency means slowing down. You wonder which $150 million will work faster.
The Chairman: Thank you all for coming. We appreciate you taking the time to be with us.
Honourable senators, our final panel is from Food and Consumer Products of Canada, CropLife Canada and Bayer CropScience.
The first presenter will be Mary Ellen Mills from Food and Consumer Products of Canada.
Ellen Mary Mills, Director of Policy Development, Food and Consumer Products of Canada: Thank you for providing the opportunity to speak to you today. I hope all of you have the brief submission in front of you. I will not read from it word for word.
Before I make substantive remarks on Bill C-28, I would say a few words about our industry. Food and Consumer Products of Canada represents approximately 130 Canadian operated companies. Our industry is a serious and significant contributor to the Canadian economy, both in terms of GNP and job creation. Across the country, we employ 350,000 people.
The continued sustainability of our industry is not only in our interests but also in the interests of Canadians. We are here today to speak positively about Bill C-28 and the interim marketing authorizations that have been used to date. Passage of this bill will give the legislative authority required to what has been questioned.
Our industry tries to meet consumers' demands for their health needs and lifestyle interests. It is an evolving process. Today, you cannot open a newspaper without seeing a new study that tells you of some new benefit of a food that we have been used to or some new nutrient added to that food that will make it beneficial. As for myself, I am quite pleased with red wine and chocolate, but others have other concerns.
The Chairman: I thought those were two food groups.
Ms. Mills: Our industry has to constantly adapt, evolve and innovate to meet the needs and demands of consumers. We operate in the global marketplace. Studies often are finalized in other countries, the results published, and these nutrients or novel foods are approved, and our industry here is anxious to be able to do the same.
The IMAs shorten that process. The Health Canada officials guaranteed that the scientific evaluations will be done so the health of Canadians will not be endangered. This will allow our industry to commercialize or bring a product to market faster than if we had to wait for the full Gazette I and Gazette II processes.
The Food and Drugs Act, which is the primary legislation that governs our industry, is decades old and woefully in need of modernization. Our industry has been working with Health Canada both on specifics and on the larger initiative of legislative renewal. That has been under way for a number of years and it will be a further number of years before we see some changes. The most needed change is in the area of health claims, but that is not the subject of this meeting
It takes a long time to set new policies. We worked on fortification for years, and that just came out in the spring. The Gazette process allows certain elements to be taken forward faster, if the full scientific evaluation has been done.
I need not say much more except that our industry is most supportive of IMAs and of this bill. Passage of this bill will eliminate the doubt that the minister had the proper legislative authority. The seriousness of our concern and our support for the bill is evidenced by the fact that representatives of one of our companies is willing to come here today to answer questions from our perspective.
The Chairman: Ms. Chang, would you care to say something or are you waiting for questions?
Michi Furuya Chang, Senior Manager, Scientific Affairs, Kraft Canada, Food and Consumer Products of Canada: I can wait for questions, if there are any.
The Chairman: Our next witness is Peter MacLeod from CropLife Canada.
Peter MacLeod, Executive Director, CropLife Canada: Thank you, Mr. Chair. With me is Chris Warfield who will help me answer any questions you may have, but he will not be speaking separately on this issue. I assume you have the brief that was submitted.
I will spend a few seconds introducing our association. CropLife Canada is a trade association that represents the manufacturers, developers and distributors of pest control products and bio-technology products in Canada, segmented mainly in agricultural markets but also in public health and urban settings.
The Chairman: For clarification, as you know, banning pesticides used to enhance lawn care has caused problems in the Ottawa area recently. Are they part of your group or are you on the agricultural side? Is there a different group that deals with what I would call "domestic pesticides"?
Mr. MacLeod: We have a group within CropLife that looks after that, but we are part of the same organization. We are the developers and manufacturers.
The Chairman: You must be busy across the country these days.
Mr. MacLeod: We are busy in every municipality.
Our interest in Bill C-28 is that pesticides were regulated in Canada under two main acts: The Pest Control Products Act and the Food and Drugs Act. As the departmental officials described earlier, the first part, under the Pest Control Products Act is to assess the studies, assess safety, and decide whether a product should be allowed to be marketed in Canada.
The second part is, after the Pest Management Regulatory Agency decides that a product is appropriate to be used on a food commodity, it proposes a maximum residue limit. Then that must be established in law under the Food and Drugs Act.
Our main concern is the time lapse between when the regulatory officials decide that a product is appropriate to be used on a food and they propose a maximum residue limit, and when the amendment is made to the Food and Drugs Act. Bill C-28 will help to shorten that time frame, firmly establishing the IMA process and also giving the minister authority to directly establish those maximum residue limits. We see that as favourable. Farmers across this country rely on these products to grow the food we all consume, and, certainly, this delay, as we heard earlier, can cause one or two seasons' delay in them having access to new technology.
CropLife Canada is firmly supportive of this bill and applauds the government for taking this step to speed up this process.
The Chairman: With respect to the one or two seasons' delay, does that have a significant economic impact on farmers? If you do not have the new technology or the new additive, does that make it harder for you to sell your product or, alternatively, do you have to sell it at lower prices because, in a sense, it is not the most up to date and modern possible?
Mr. MacLeod: This year and the past year were tough economic times for farmers across Canada. When our companies introduce new technology to better control pests better in a more environmentally responsible way, delays can be caused in them even being able to try the product out. They will not use a product on their crop if they are not assured, when harvest time comes, that they will be able to sell it. Typically, they will not use the new technology until the Food and Drugs Act is amended.
The Chairman: I am trying to understand what economic impact there is to individual farmers. Does it get the farmer a higher price in the marketplace or does it lower production costs? What does it do for the farmer?
Mr. MacLeod: Typically, the main benefit has to do with production costs. In some cases with regard to minor use on crops across Canada there may not even be a control out there for a particular pest. If a farmer is trying a new innovation, such as is happening in Western Canada where they are growing more chickpeas, they may not have a fungicide controls disease on that crop because it is a relatively new crop to Canada. In some cases, they would not have a control available to them, while in other cases it gives them another tool to use.
Senator LeBreton: Using chickpeas as an example, and to follow up on Senator Kirby's question, their competitive advantage or disadvantage can be affected. If they are growing chickpeas, and they want to sell them into the United States, and in the U.S. they have this product that is helping their crop, it would put our farmers at a disadvantage economically, would it not?
Mr. MacLeod: Yes. One of the key concerns of the farm community across Canada is having access to the same products as are available in the U.S. at the same time, as well as having a maximum residue limit established so they can sell that product abroad.
Senator Keon: That seems to be the Achilles heel of your whole submission. I read your previous submissions and so forth. However, you were not explicit, and perhaps you cannot be, as to just how much this is hurting the people in CropLife Canada. How much are the current delays setting you back? You are getting to the same position as your American competitors in any event. There are no secrets across the borders; there are just delays. How much is the current process hurting you?
Mr. MacLeod: The economic hurt is the delay in coming to market. As Ms. Dodds earlier indicated, it takes up to 10 years, 240 separate studies and over Can. $300 million to bring a new product to market. That two-year delay in being able to market and sell that product has a significant economic impact on our member companies.
Chris Warfield, Director, Regulatory Affairs Canada, Bayer CropScience: It goes even beyond that because, as Mr. MacLeod has indicated, from the time we discover something and patent it, we have 10 years of development. We have a patent that runs for 17 years. I am sure the same situation applies to drugs. We have at least three years of regulatory time to get a product registered. Once we have the MRLs defined, we have, potentially, another two years of regulatory time to put the maximum residue limits in place before the products can be used. If you add up all that time, there are not many years to recoup your investment which, as Mr. MacLeod indicated, is potentially Can. $300 million.
I have also worked in Health Canada where I was responsible for setting maximum residue limits. We end up facing two issues. One is the domestic issue with the growers, and the other is trade. When we do not establish maximum residue limits in a timely manner, we interrupt trade. CFIA will capture these things. There are maximum residue limits in law. Currently, Canada has no mechanism to respond to that requirement. For the most part, this will provide a tool to government officials to respond not only to the domestic piece, which is providing growers equal access to the products at the same time and enabling trade, but it will also deal with trade on an international basis, which is the other half of this process.
Senator Keon: You raise the analogy of the pharmaceutical industry. In that industry, the race to get a product to market heats up at the top end. That is because there are few secrets in the scientific world. At the bottom end, everyone uses the same database. However, if someone gets a two-year lead on you to market, you have a terrible problem. I am trying to find out just how bad your problem is. Certainly in the world of pharmaceuticals it would be a terrible problem. If two analogous drugs for the treatment of heart failure are in the pipeline and one can be marketed two years before the other one, that is a tremendous advantage. Tell us a little more about the specifics of this happening in your industry.
Mr. Warfield: The other aspect is that it puts government officials in a bit of a quandary. Certain products come into Canada and they spend three years in evaluation and the maximum residue limit is proposed. Under the Pest Control Products Act the product is registered. What does the government official and the company under stewardship do? Do we wait for two years for a maximum residue limit to be established, or do we sell the product on the understanding that the maximum residue limit has been defined and is being proposed but has not been put in place yet? Where does that leave CFIA in their enforcement responsibilities? It is a real dilemma. This bill addresses that directly and puts everyone back on a sound legal basis.
The Chairman: Are there any further questions?
Senator Fairbairn: Mr. Chairman, I have a comment more than a question.
In your paper you make reference to NAFTA and the technical working group. You say that this was part of the agreement to assist removing trade barriers. Yet, according to your brief, Canada has encountered technical barriers with no near-term solution in sight. You see this bill as a method of getting around that. Am I correct in that statement?
Mr. MacLeod: Yes. This bill is certainly part of the solution. It is far from the complete panacea. As some department officials mentioned earlier, there is an active process now ongoing to harmonize the way the studies are done between Canada and the U.S. If that comes to a completion phase, hopefully farmers in Canada will have access to the same products that are available to farmers in the U.S. Currently, there is still a gap. Officials are working hard on making that gap smaller. However, it still exists. Until we reach that phase, there will still be these trade barriers and discrepancies in the tools available to growers in Canada as compared to those available in the U.S.
Senator Fairbairn: It is too bad we cannot build a bridge like that on softwood lumber.
The Chairman: Thank you for coming. We appreciate it.
Honourable senators, can we then move to clause-by-clause consideration of the bill?
Hon. Senators: Agreed.
The Chairman: We can either deal with the bill clause by clause or I am happy to entertain a motion to report the bill back next Tuesday without amendment.
Is that agreed, honourable senators?
Hon. Senators: Agreed.
The committee adjourned.