Proceedings of the Standing Senate Committee on
Agriculture and Forestry
Issue 29 - Evidence - Meeting of February 14, 2013
OTTAWA, Thursday, February 14, 2013
The Standing Senate Committee on Agriculture and Forestry met this day at 8:05 a.m. to examine and report on research and innovation efforts in the agricultural sector (topic: Canadian regulatory framework and its impact on innovation in the agriculture and agri-food sector — pest management and food regulation).
Senator Percy Mockler (Chair) in the chair.
[English]
The Chair: I welcome senators this morning. We have two witnesses separated into two different panels because of the fact that one panel will be on pest management in the agri-food sector and the other one will be on food regulation.
[Translation]
Regarding our work, the Senate order of reference specifies that we study the development of new markets domestically and internationally; we are also examining enhancing agricultural sustainability.
[English]
We also study improving food diversity and security. The first panel, honourable senators, will be Marion Law. Before I introduce her, I would like all of the senators to introduce themselves. My name is Percy Mockler, a senator for New Brunswick and chair of the Standing Senate Committee on Agriculture and Forestry.
Senator Mercer: I am Senator Terry Mercer from North End, Halifax.
[Translation]
Senator Robichaud: Fernand Robichaud, Acadia, New Brunswick.
[English]
Senator Callbeck: Catherine Callbeck, Prince Edward Island.
[Translation]
Senator Tardif: Good morning; Claudette Tardif from Alberta.
[English]
Senator Plett: My name is Don Plett. I am from Manitoba.
Senator Buth: I am JoAnne Buth from Manitoba.
Senator Eaton: Welcome. Nicole Eaton from Ontario.
[Translation]
Senator Maltais: Good morning; I am Ghislain Maltais from Quebec.
Senator Rivard: Michel Rivard, the Laurentides, Quebec.
[English]
The Chair: The committee is continuing its study on research and innovation efforts in the agricultural sector. Today we have with us Marion Law, Chief Registrar and Director General, Pest Management Regulatory Agency, Health Canada.
Ms. Law, thank you very much for accepting our invitation and for sharing your expertise and your vision in the agri-food sector of Canada. On behalf of the committee, if we feel that we will want additional information, we will ask our clerk to communicate with you for additional questions if need be. Following your presentation this morning, you will have questions from the senators. Please make your presentation.
Marion Law, Chief Registrar and Director General, Pest Management Regulatory Agency, Health Canada: Good morning, Mr. Chair and honourable members of the committee. My name is Marion Law, and I am the Chief Registrar of Health Canada's Pest Management Regulatory Agency. I appreciate the invitation to appear before you today. I am pleased to have the opportunity to discuss PMRA's mandate and responsibilities and to highlight the agency's contribution to innovation in the agricultural sector.
[Translation]
The Pest Management Regulatory Agency is the branch of Health Canada that is responsible for the regulation of pesticides. Our mandate under the Pest Control Products Act is to protect human health and the environment from any unacceptable risks from the use of pest control products, while at the same time ensuring these products have value. Pest control products include conventional agricultural chemicals and biopesticides as well as industrial chemicals and consumer products. Only pesticides approved by the PMRA can be imported, sold, or used in Canada.
[English]
When considering an application to register a pest control product in Canada, the PMRA conducts a very detailed scientific assessment to ensure that the risks to health and the environment are acceptable.
[Translation]
The PMRA is very aware of the important role crop protection products play in agricultural production and competitiveness. Today, I would like to share with you some of the innovative approaches the PMRA is pursuing with respect to pesticide regulation.
[English]
Since the 1990s, the PMRA has been working collaboratively with our international regulatory partners, beginning with participation in the NAFTA Technical Working Group with the United States and Mexico and now expanding through to the OECD Working Group on Pesticides, where we continue to work closely with the U.S. and Mexico, as well as with many other countries around the world. Through these two fora we have built the foundations of aligned scientific approaches, including science policy, data requirements, guidance and tools. These approaches have been successfully implemented with other regulatory authorities through a joint scientific review and work sharing program. I am very pleased to report that approximately 75 per cent of the new agricultural chemicals approved last year for use in Canada were as a result of a joint review either with the United States or with other OECD partners.
[Translation]
This joint scientific review approach applies both to new conventional agricultural chemicals and new technologies such as biological pesticides.
[English]
The benefits of this joint review program are positive for all stakeholders, including our global regulatory partners, Canadian growers and industry. This approach facilitates simultaneous international registration decisions, which can allow access for our growers to new technologies at the same time as growers in other countries. This can be extremely important for agricultural competitiveness. In addition, submission of the same science dossier to all participating countries at the same time in a joint review results in resource efficiencies for both the industry, who combine the scientific dossier, and the regulatory authorities, who review and produce the risk assessment based on that data. This also provides better access to global science, resulting in better decision making.
[Translation]
Stakeholders have been very supportive of this type of collaborative approach. We continue to strengthen collaboration with our internal partners under the Regulatory Cooperation Council.
[English]
Since January 2011, the PMRA and our Environmental Protection Agency counterparts in the United States have been engaged under the Regulatory Cooperation Council to identify innovative mechanisms that would encourage manufacturers to submit new technologies for approval at the same time in both countries. This work will also help ensure that a greater number of products are available for minor crop uses and horticulture and will reduce potential trade barriers in areas such as standard setting for pesticide residues on food.
We know that standard setting for pesticide residues on food commodities by many countries can present trade challenges and may even affect the nature of crop protection products that Canadian growers can use. That is why we in the PMRA are working with our counterparts in other countries through the OECD and the Codex Alimentarius Commission to help mitigate this problem.
[Translation]
In closing, we believe that the advances we have made in international collaboration and cooperation have helped and will continue to help Canadian agriculture, and benefit all Canadians.
The PMRA will continue to work with stakeholders on regulatory approaches and practices that contribute to innovation in the agricultural sector while maintaining our high standards of human and environmental health protection.
Thank you for the opportunity to be here today, and I am happy to answer any questions you may have.
[English]
The Chair: Thank you, Ms. Law.
Senator Plett: Welcome to the committee this morning. You briefly skimmed over my first question. I would like you to elaborate on innovative mechanisms that would encourage manufacturers to submit new technologies for approval at the same time in both countries. One of the criticisms has been that we are sometimes behind the United States in getting approvals and that we are losing a bit of our competitive edge as a result. Could you elaborate on what we are doing so we can stay at the same level as our counterparts from other countries?
Ms. Law: Yes, I agree. We have heard from stakeholders over the years of the disadvantage that often can occur if the same technologies, new pesticide products and sometimes older pesticide products are not available for Canadian growers. To address this issue, we have two approaches in the PMRA. In our global joint review program we actively participate at the front end working with other regulatory authorities and the industry to ensure that when a pesticide application is available for review by each regulatory authority, the dossier will be accepted into Canada at the same time. This means under a joint review that we are working on the science assessment at the same time. We are more likely to have harmonized decisions, working of course under our legislation. More important, in terms of providing the products for Canadian growers, we will come to a decision at the same time because the actual assessment is organized through a project plan that will give timelines for every country to work along the same plan.
We feel that this program, which has shown a lot of success, is very useful in preventing the future of an increased technology gap. The products are coming to Canada at the same time as, for example, the United States. That is in place and will prevent an increase in the technology gap.
In terms of the older products that we know still have a lot of value for Canadian growers and farmers, we have another program in place with criteria that we follow if a product is registered and has associated value, the risk assessment has been done in a country where we have confidence in their regulatory system and we have the same data requirements, we would have an expedited review with these older chemicals and would be able to make them available to Canadian growers in a shorter time. The incentive for registrants to provide that information to the Pest Management Regulatory Agency so the product can go on the market is that we review it in a significantly shorter time because of the reduced data requirements because of its use history in other countries. That will help to fill the technology gap of some of the older products that, according to stakeholders, are of very high value to them.
Senator Plett: You spoke to the time required. Could you tell us about the conditional registration of pesticides? Our information is that conditional registration needs to take only about three years but that some are taking 10 to 20 years. Why is that? The Commissioner of the Environment and Sustainable Development states that certain pesticides have been temporary for between 10 and 20 years, clearly longer than the three-year period required.
Ms. Law: We realize that we have a number of conditional registrations still awaiting confirmatory data. That has taken a little longer to come into the Pest Management Regulatory Agency for review. I will explain a little more.
Conditional registration of a pesticide is a registration that has had a full risk assessment conducted and we have satisfied ourselves that the risk to human health and the environment is acceptable. The conditional aspect of the registration may be some confirmatory data that we would like to have in our database. The data may be in terms of the efficacy of the product or regarding the storage of the chemical. The product is available to growers, although we are waiting for confirmatory data, which would have no impact on the risk assessment of the product. Often it is difficult for registrants to provide us with that data in a short space of time. We are aware that we could do better with respect to not having conditional registrations for as long as some have, and we are making an active effort to ensure that we have the data requirements upfront.
If I may just add, that is one of the benefits of a global joint review. We have a very standard dossier and a very complete set of data upfront. We hope that would reduce the requirement for a lot of confirmatory data.
Senator Plett: Thank you for that answer. I appreciate that. I would suggest that if the required period is three years, then between 10 and 20 years is not a little bit longer but rather significantly longer
Thank you. I think you have answered the question.
Senator Callbeck: Thank you very much for coming here this morning. In following up on that conditional registration, how many pesticides do we have registered in Canada and how many conditional registrations do we have?
Ms. Law: I do not have the specific numbers. Generally speaking, at the moment we have around 6,000 pesticides registered in Canada, of which about 60 per cent would be for use in the agricultural sector. I would not have the numbers and I certainly will provide the committee with that on the number of conditionally registered pesticides, but it would be a very small percentage. A conditional registration is not generally an outcome that happens very often, and I apologize. I do not have these numbers today. It is something that we avoid. Again, it would be in terms of confirmatory data supporting scientific data that we already have in-house.
Senator Callbeck: It does not happen very often. You say 60 per cent of pesticides are for agriculture. Do you just deal with the pesticides in agriculture or with all of them?
Ms. Law: All the pest control products for use in industry and also for personal use.
Senator Callbeck: This particular pesticide that was mentioned was to be phased out in 2003 and then it got the conditional registration in 2006 and then to 2009. You said there is a full assessment, so is a full assessment done each three years?
Ms. Law: No, not generally. The process speaks to a full assessment being done at the very beginning, before the pesticide is registered for use in Canada. Subsequent assessments will be carried out as the same chemical comes in for a use expansion, perhaps another crop or another pest, and then an appropriate review of the scientific data to support that would come in at that time. Always, when a chemical comes up for re-evaluation — and it is a legislative requirement that a chemical will come up for re-evaluation every 15 years — we start the re-evaluation process. During that period of time there can be use expansions to an existing chemical at the same time as it is under evaluation, and we have to take that into account as we continue on with that risk assessment to see if any information at all coming out of the re-evaluation process would change the initial decision to register.
Senator Callbeck: With this particular pesticide and the conditional registration that has gone on for several years — and it says here, I believe, extended to 2009 — do they have another conditional registration, or is that off the market now?
Ms. Law: I am not sure if I can answer that question because I am not sure of the "active" that we are referring to. I could certainly provide information on that.
Senator Callbeck: I come from Prince Edward Island where agriculture is the main industry and I hear a lot about pesticides. How closely do you work with the provinces? Could you give some specific examples of how you are working with, let us say, my province?
Ms. Law: We consider our relationship with the provinces to be very strong. We work very closely — and, indeed, we need to work closely — with the provinces because they share some legislative responsibilities for pesticide use in Canada. There are federal responsibilities and provincial responsibilities. We work through our FPT committee. In terms of all of our other programs, we have links with the provinces to obtain their views and actually try to meet their needs.
We are very aware of the particular needs of Prince Edward Island. One example that comes to mind in terms of how we work with the province is the mitigation of risks associated with pesticide runoff. We have worked very closely with our provincial colleagues there to ensure that pesticide labels do have appropriate mitigation instructions. Also, we do work with a number of committees at the provincial level to help with respect to best practices to assist again to prevent runoff and how to develop vegetative barriers to deal with the specific terrain in Prince Edward Island, which may actually contribute to pesticide runoff and perhaps non-targeted organism kills. That is one example I can think of.
Senator Buth: Thank you very much for being here this morning. I was involved in the very first joint review with PMRA a while back, so I am really impressed to see the 75 per cent figure. That was clearly identified by industry as an opportunity to ensure that there were going to be safe products but they would be registered at the same time.
I have some questions to help me understand where we are at in terms of some of the joint reviews. What differences do Canada and the U.S. have in terms of science reviews? Are there any differences between how Canada and the U.S. review things on the science side?
Ms. Law: Over the years we have come closer together in terms of reviewing through the science side. That work has been facilitated by the actual science work we do through NAFTA and the OECD, where we actually sit down and we talk about the approach that we take to reviewing the science. We actually work out, for example, the same methodology in calculating statistics associated with the science review; that is, the calculation of maximum residue levels. We do that the same way. All that helps our scientists come together and take the same approach.
In terms of the way we review our science, and because we get the same information in the same format and in a template in the same way, that all helps our scientists to move together and to be able to work closely together and share their scientific opinions.
Where I think there still are some differences would be around the science policy that we may have in each of the countries. That usually stems from the different legislation, but we do find that that is increasingly becoming not so much of an issue. Our legislation is modern and is flexible, so we are able to work together very closely in harmonizing our science approaches and in looking at some policies.
One difference we do have in Canada, and I think industry has probably made you aware of this, is that the PMRA is legislated to ask for value information so that we know that the product does have value to a Canadian grower. That is something that the U.S. does not ask for, but that does not prevent us from working together. Indeed, when a chemical does come up for re-evaluation in Canada and also in the United States, often the United States are very interested to receive our value, our efficacy data, to use at that time. The short answer would be: We are coming very much more closely together in terms of our approaches to the science review.
Senator Buth: I may be wrong on the number, but I recall that Canada used to apply an additional safety factor in terms of one of the risks to humans. Is that still the case?
Ms. Law: That would be on a case-by-case basis. Most certainly that would fall under the differences in science policy where we apply safety factors. The U.S. also has their policy of how they apply safety factors.
If I can go back to the joint review process, when we are both working on a science assessment and a risk assessment at the same time, often, based on the data we have, we are able to address these science policy differences and come to a harmonized decision. However, having said that, we do have Canadian standards that we feel are appropriate for human health and the environment, and we take heed and pay attention to these safety factors.
Senator Buth: One of the things growers often say is that a Canadian consumer is very much like an American consumer in terms of what they are eating. A bystander in terms of a pesticide application would be virtually the same. Why can we not just accept products that are registered in the U.S.?
Ms. Law: It is a very interesting question, and PMRA gets asked this a lot. It has particularly been asked through the Regulatory Cooperation Council. We do have Canadian legislation that governs how we work together. We do take the point, yes, that there is very little difference in terms of the population in the U.S. and Canada. We are so closely aligned now in terms of how we evaluate products on the label statements that we make and the access that we are very harmonized in our decisions.
Senator Buth: I will go back to what I probably should have started with. A lot of people who do not work with pesticides, and perhaps people who live in cities, do not realize the extent to which a product is actually evaluated. Can you briefly tell us what types of things you look at before a product is registered in Canada?
Ms. Law: Again, I will preface this by saying I will be happy to provide any other information. First of all, we would look at whether the product has value to Canadian growers, if we are talking about an agricultural product.
We then do an intensive review of the chemistry around the chemicals that make up the formulation of the pesticide and also the manufacturing process, and particularly we would look for any impurities that the manufacturing process may or may not throw up.
Then we would look at the toxicology associated with that product, both acute toxicology in terms of whether there is a problem that this pesticide could cause immediately but also long term and any chronic impacts that the use of the product would have.
We also look at the dietary risk assessment because we are eating these crops and there will be residues of pesticide in or on the crops, and we have to ensure that they are at an acceptable level to ensure safety to human health. A direct result of that is the MRL that we set.
We also look at the safety associated with any bystanders. That would be particularly important in an urban setting. If a pesticide were to be sprayed, what is the exposure to bystanders? Also, we would look at the toxicology associated with the use or application of the product to the applicator. That is where we work closely with provinces that have regulatory jurisdiction over that area as well.
Then we look at environmental assessment, where we would look at the environmental fate, that is, where is the pesticide running to, where is it going, how long will it stay in the ground and how persistent is it, and also the ecotoxicology of the environmental assessment, particularly with respect to the effect of the pesticide on what we call our non-target organisms. That could be fish kills, for example.
The label is a legislative requirement and is the key piece of information that allows the product to be used appropriately, so we spend time working with the scientists and the registrants to ensure that the label provides appropriate directions for use and mitigation.
Senator Buth: Would you say that products being registered now would have better safety characteristics or be softer on the environment? If that is the case, could you give us an example of a product that would be considered less harmful than the products that were registered 40 years ago?
Ms. Law: That is a question we are often asked. In general, I would need to say that with the new technologies being developed and provided to the regulatory authorities to review, modern technology does in general have less risk associated with its use. We see that in terms of a lower application rate and also the mode of action and the chemicals. The new technologies seem to be very much more targeted to a specific pest or weed as opposed to some of the older chemistries that were much broader spectrum and perhaps had more issues associated with them.
In general, I would say the modern products are reduced risk. Pesticides generally are considered to have less of an impact on the environment, and also we have non-conventional products. The organic sector, for example, is very interested in having registration for these products. Again, these products do tend to have a lower risk profile, although we have to balance that with the intent of the product and where it is to be used.
There will be products, and there are, that still have risks associated with their use. There are obviously some, and our role is to ensure that these risks end up being acceptable when the produce is used according to the label and the mitigation factors that we have put in place, specifically for the environment, things like buffer zones, the space between where you can use the chemical and where you cannot, and the types of ground that the products are used in. There are a number of mitigations factors we would use to ensure that the risk to the environment is decreased to the extent possible.
Senator Mercer: Ms. Law, thank you for being here. As the longest current serving member of this committee, I am excited that you are here. I have sat here and been one of the people who have complained about the lack of coordination in our approval of products used in the agricultural sector. I do not know that Senator Buth meant this, but I, for one, am happy that there is a Canadian filter on the approval process and that we do not just accept what others say.
Tell me about the speed of approval now. This has been an ongoing problem. We have had farm groups and industry groups come and tell us that it is taking much too long to get approval. What is the average approval time now?
Ms. Law: There are different categories of pesticides that go into all kinds of details. Generally speaking, for a newly developed chemistry, with our timeline in Pest Management Regulatory Agency, it would take two years to get a product in and have a decision at the end. Probably the most important comment I can make is that our timelines are comparable with the rest of the world, including the U.S. That is where we have made a lot of improvements.
Again, if we work share with other countries, that approval time is less. It could be about 18 months. Six months does not sound very long, but as you know, if you are a farmer, it is all about the new season and not so much about the time it takes. You need to get the product for whatever new season you need it for. When we work globally and work share, we have reduced that approval time to 18 months.
I am very pleased to report that the PMRA does not have a backlog of submissions and that our approval time matches those of other countries at the OECD and that of the U.S. We strive to keep it that way.
Senator Mercer: That is excellent news; please keep up the good work.
Perhaps, for the benefit of all of us here and for the people watching at home, you might walk us through perhaps two examples of products that come to PMRA, strictly from a Canadian perspective. What is the process? You have given us the timeline of approximately two years. Use another example of a product that comes to us at the same time as it may be going through in a partner country in the OECD or through in the U.S. Give us a quick sketch as to what happens and how the process works.
Ms. Law: The actual risk assessment generation follows the same process. It is the same dossier, and we would review the same signs and look at the same calculations. That is the same.
The big difference would be that if it is a Canadian-only product, it would have a slightly longer time to go through. Of course, all of our information comes to us electronically, so we are not dealing with paper anymore. The information would go off to our scientists. They would evaluate and do the hazard assessment and then the risk assessment. We would work on the label, and we would make a decision. It would be the PMRA only, working with provinces. It would be a domestic registration and process.
Alternatively, if we are working at a global joint review — and the new chemistries tend to be like that — the science we look at is very much the same, but the process is that we would start what we call the discussions around the chemistry maybe two years before the registrants present the science dossier to the regulatory authorities. We have international work planning meetings with the registrants and the regulatory authorities. We will listen to the registrants explain some of the science associated with the new pesticide and, more particularly, the objective of the product. That is a very important distinction because it gives us, as countries — with me representing Canada — the opportunity to actually say to registrants, "You are not planning on submitting this for two years. You still have a significant amount of data to generate. We hear from Canadian growers in whatever sector that they need a particular product — an insecticide, for example — for this use. Would you consider generating data? That use could then be submitted to Canada as well."
We are excited about this opportunity because we are working very closely with our stakeholders. We feel we know their needs. We do not advocate on behalf of our stakeholders, but we know the needs of the different sectors. That is our opportunity to work for them with the registrants, and it is early enough.
Then, we just work with other countries, splitting up who will do what part of the science review when we all get together for a peer review, and then each country makes its own decision based on the risk assessment that we do at the end. We communicate that and then post the evaluation for Canadians to read.
Senator Mercer: That is excellent. How many employees does PMRA have and how many would be scientists?
Ms. Law: Currently, we have just over 400 employees. I do not have the specific numbers, but the majority of PMRA employees are scientists. They cover the toxicology and environmental fields or are chemists or specialists in agriculture.
Senator Eaton: Ms. Law, as you know, we are now in trade negotiations with the EU and possibly with the TPP. Do you have a representative at the table, or do you have to have a representative at the table? Are questions of pesticide residues ever brought up in these negotiations?
Ms. Law: I do not have a role in these negotiations. Currently, I know, through our policy areas and directorate, that they provide information. I am sure our views are being taken into account. I would not be able to answer that question, and I certainly could get back to the committee with that information.
Senator Eaton: Could you perhaps come back to the committee with any hurdles Canadian growers face because of the use? For instance, I know that right now the EU has an issue with hormones in beef and pork. It would be interesting to find out whether there are pesticides we use that would come into it.
Do you have a relationship with research that is presently being done in Canadian universities? Do you use Canadian universities?
Ms. Law: Generally speaking, PMRA does not have the mandate to get involved with research.
Senator Eaton: Do you use their research in your data?
Ms. Law: Our data mainly comes from the registrants when it supports a submission for the registration of a pest control product. However, in terms of the development of new science work that we are doing, the best example I can think of at the moment is that we are, under the banner of 21st century toxicology, moving away from toxicology studies that use animals into more of an in vitro environment. We work closely with a number of universities to help us with that research.
We are always linked in to where we need to be, and that is the way we would normally do business in terms of collaboration.
Senator Eaton: I am sure this is an ignorant question, but just confirm it for me. I guess you only deal with the registrants, but is there any relationship between GM seeds and pesticides?
Ms. Law: Again, thank you for that question. Normally that work would be done with the Canadian Food Inspection Agency. We do not have a huge role in terms of policy and scientific research around that area.
[Translation]
Senator Tardif: Good morning, Ms. Law. In your presentation, you mentioned the joint scientific review approach to new conventional agricultural chemicals and new technologies such as biological pesticides. Is the biopesticide industry very developed, and does the PMRA encourage the use of biological pesticides?
Ms. Law: Thank you, madam, for your question. I would like to answer in English if you do not mind.
[English]
Yes, the PMRA very much encourages new innovation and new products. We have been very successful, again, in our collaboration with the U.S. EPA to jointly review a number of biopesticides. It is an area that we see is growing. We have put incentives in place, in the past, to encourage manufacturers of biopesticides to register their products in Canada. One of the incentives, for example, was that they were exempt from cost recovery. We did not want to put a barrier in place. As a result of that, I think we have been very successful, and we have registered a large number of biopesticides. We realize that it is a growing area. We work very closely, of course, with registrants, and they will come in and inform the PMRA of the products that they will be bringing to market in Canada so that we have a bit of an idea for a work plan. We even see now that the more conventional companies, such as Bayer for example, are now branching into the manufacture of biopesticides. I think we can take from that that it will be a growing industry, and I think the PMRA is well equipped to handle that need as well.
[Translation]
Senator Tardif: Do you have some idea of the percentage of producers in Canada who use biological pesticides?
[English]
Ms. Law: I do not know. We feel we need to get a better handle on that area, if I may say. We have a regulation in place that requires registrants to provide us with sales data. This is the indicator that we would use to show all the work we put into registering products — to know whether they are being used and sold in Canada. The sales data is always a little behind, maybe two or three years, so we do not have accurate information in terms of how many biopesticides or the extent of the use of biopesticides in Canada.
We continue to have a lot of submissions and interest in these products, so one could assume that there is a need, or these registrants would not come to Canada. I could go back to the PMRA and find that information to provide to the committee.
Senator Tardif: That would be appreciated.
[Translation]
One last question: you said that there was a lot of potential in the biological pesticide sector; but do you think that these products present less risk to human health and the environment?
[English]
Ms. Law: It is generally accepted that biopesticides have a reduced risk with respect to use in the environment. Certainly, they would have reduced risk associated with human health. I would like to suggest that the use of biopesticides is another tool in the tool box, as we like to say. There is a time when growers can use a biopesticide for a given situation or problem that they have, and there may be a time when they have to use a conventional pesticide.
Our understanding of biopesticides is that they can be used alone but often are used as part of a number of pest management tools, and their place is very important.
[Translation]
Senator Robichaud: What I am interested in, Ms. Law, is the issue of residues. When you assess a new product, I am certain that you examine its chemical or biological composition, as well as the methods used to apply it. Perhaps the application methods have an effect on the residues that may remain after the crop has been harvested.
What is your method? You need tools to measure residues and that is a part of the assessment, is it not?
[English]
Ms. Law: Yes, part of the environmental assessment process will take into consideration how the product is applied and the residual effect from that product in the environment, whether it is persistency in the soil or in the air if it is applied by aerial spraying. We have a number of mitigation methods that our scientists put on the label, which growers have to adhere to, to minimize the residual impact of the pesticide.
Where we feel that we need information is in the continual monitoring of the pesticide after application, maybe even for a number of years after a pesticide has been available for use in Canada. We can assess it based only on the application to that crop at that time. It continues to be important for us to work with the provinces to deal with monitoring data for the environmental fate of the product to know whether it is persistent in the soil, whether it is going into groundwater, and what is happening to the pesticide.
[Translation]
Senator Robichaud: What I am concerned about, madam, are the residues that may persist and reach the consumer. I understand that you are examining the use of these products, what remains in the ground, the runoff, and so forth. But I am also very concerned by the health of consumers. We import a lot of grapes from South America. Someone told me this about those grapes: "By the time we notice that there is something amiss, it is already too late, and everything has been sold."
Are there any methods to monitor those products to detect whether they contain pesticide residues? Because if there are no such methods, we are in fact trusting application protocols — and people — we do not know.
[English]
Are there methods to detect excess residue on the foods we eat?
Ms. Law: We would do that when we set the maximum residue level as part of the dietary assessment. We realize that after every application residues will remain on the crop or in the crop. The maximum residue level would be part of the risk assessment. Every country that evaluates a pesticide will set that residue level as well. It is always done according to the parameters of acceptable risk to human health. Methods are available. In fact, the methodology today is so specific that, as I heard recently, they are looking at pesticides in parts per trillion. The analytical methods can go down to that sort of level. We look at that data when we establish the maximum residue level on crops.
Senator Robichaud: I understand that part of it. I understand that you rely on people applying the products according to the specifications.
Ms. Law: Yes.
Senator Robichaud: When the product is on the shelf or even before it gets there, do you have methods to detect the level of residue?
Ms. Law: If I may clarify, you are asking about residue after the product is used and whether the PMRA has a program in place where we would take some samples of the crop and look at the residue.
Senator Robichaud: Yes, to see that it meets acceptable residue levels.
Ms. Law: The PMRA does not have such a program. The Canadian Food Inspection Agency would be responsible for taking samples, maybe at the border. I need to find out more to know whether they would go into an area and take samples or whether it would be as a result of a complaint. The PMRA does not have such a program.
The Chair: We visited stakeholders in the meat processing side of the Canadian food industry. They assured us that as they are going forward and that a tool will be available for retailers so consumers will have information on a label to know immediately when it was produced, how it was fed, et cetera. If you could follow up on Senator Robichaud's question, we would certainly appreciate it.
Ms. Law: Certainly.
The Chair: As we all know, farmers, regardless of where they live, want to look at best management practices. Some witnesses shared with us that research has evolved to the extent whereby it is possible to use nanotechnology to produce fertilizers that would be applied according to the needs of plants rather than just spraying generally. That is quite a revolution. We also heard from witnesses that the legislation does not always allow the approval and use of products resulting from new technology or nanotechnology.
For the next two questions you can either respond now or respond in writing. Are there pesticides that are produced using nanotechnology and what percentage? What is done to foster products for nanotechnology in order that we target plant needs rather than just doing what we call an ordinary application? I leave it up to you, Ms. Law.
Ms. Law: This is new technology for pesticides, so I would like to go back and give you a fulsome answer that will inform the committee.
The Chair: Thank you very much.
Senator Callbeck: You mentioned that roughly 400 people are employed with the agency. Has that number been pretty consistent in the last five years?
Ms. Law: No, that number has actually decreased over the last few years.
Senator Callbeck: By how much; do you have any figures?
Ms. Law: Again, it probably is a little before my time, but I think at some point the agency did have more than 500 staff on board.
Senator Callbeck: Could you get the figures for the last five years, let us say, and send them to the committee?
Ms. Law: Yes.
Senator Callbeck: On the timelines, you mentioned two years, which is comparable with the United States. Are we satisfied with that two-year time limit, or are you still trying to improve it?
Ms. Law: In the agency we are always looking to improve. We know there is a lot we can do to provide services to the agricultural sector. Certainly, we are very happy with our performance at the moment. More than cutting down the total approval time, we would be focusing our efforts more on predictability because we very much understand that these products are dependent on the season. We want to be able to hone in on our processes. For example, where products are required for the spring, if we have flexibilities in process, we can move these through a little faster than perhaps focusing on products that we will not need for a certain time. We are hearing from our stakeholders that they would like us to focus a little bit better on predictability, and we think we can improve on that.
Senator Callbeck: You say that assessment results are available to the public.
Ms. Law: Correct, yes.
Senator Callbeck: Is that all assessments, whether negative or positive? Does it matter?
Ms. Law: For the new chemistries we have evaluation reports posted on our public registry, regardless of the decision. There is a consultation period for Canadians to look at that assessment, and their comments are taken into consideration along with anyone else.
Senator Robichaud: You say the information is available and the public can comment. Do you get many comments from the public when this information is put out?
Ms. Law: Generally not. I think that is another area. We want to make it easier for the public. Evaluation reports are drafted by our scientists. They are lengthy and very much specific to the science that we have reviewed, so they might not lend themselves to the public being particularly interested. That is one area where I think we could improve because we would very much like to hear from Canadians.
Senator Buth: I have a question on the minor use of pesticides. This has been a really important program for growers who have crops that the pesticide industry does not see the value in the registration process because the crops are quite small. What kind of support do you provide for the minor use program? Is it adequate?
Ms. Law: Of course, we are aware of the importance of this to the agricultural sector, particularly the horticultural sector, so we work very closely with Agriculture and Agri-Food Canada. The PMRA contributes because we will review the residue data that comes in and that will allow the minor crop to be added to the label. That is a separate program where there are a focused number of resources to ensure that timelines are competitive. We take this very seriously.
If I can go back to the global joint review process, it really helps us across all of the agricultural sector and the registration of products. Again, when we talk to registrants a number of years before they will come in with a product, that is where we can talk about minor uses and ensuring that we get minor uses on the product right from the beginning as opposed to having only a few uses when the new technology comes in and waiting for a use expansion to come later. We feel that that has contributed a lot to minor use. Of course, the whole focus on the Regulatory Cooperation Council for pest control products is very much focused on getting as many minor uses filed at the same time, setting the import MRL at the same time. I hope the agricultural sector feels we are contributing a lot to that. We are always listening to the sector to get more ideas and move these into our processes as well.
The Chair: Thank you very much for sharing your vision and the comments of Health Canada.
Honourable senators, our witness this morning Mr. Anatole Papadopoulos, Director, Bureau of Policy, Regulatory and Governmental Affairs, Food Directorate, Health Products and Food Branch, Health Canada.
Mr. Papadopoulos, thank you for accepting our invitation to share with us your views and comments on health products from Health Products and Food Branch Canada, in view of our order of reference. I will ask you to make your presentation, and senators will follow with questions.
Anatole Papadopoulos, Director, Bureau of Policy, Regulatory and Governmental Affairs, Food Directorate, Health Products and Food Branch, Health Canada: Thank you, Mr. Chair, distinguished members. I want to thank you for the opportunity to speak with you this morning about Health Canada's efforts to create a more modern and streamlined regulatory system.
The global marketplace is evolving and consumers want new, safe, innovative products and are informing themselves to better look after their health and well-being. Before I outline recent improvements that have been made to our regulatory approach to address this, I would like to take the opportunity to briefly provide committee members with an overview of Health Canada's role in Canada's world-leading food regulatory system.
Health Canada's mandate is to help Canadians maintain and improve their health. The department establishes policies, regulations, standards and guidelines related to the safety and nutritional quality of all food sold in Canada. As you know, compliance and enforcement of these rules is the responsibility of the Canadian Food Inspection Agency.
For the majority of food products available on the market in Canada, the rules and requirements are set out in the Food and Drugs Act and associated regulations. This means that manufacturers can take products that meet those requirements directly to market. For example, the regulations identify which foods must or may contain particular added vitamins and mineral nutrients and at what levels, specify certain acceptable health and nutritional claims, and contain standards that include microbiological criteria, chemical criteria and labelling requirements on hundreds of food items.
[Translation]
Food manufacturers will know by looking at the regulations what they can and cannot add to a product or do to a product before they can sell it. In this sense, the government's oversight of these products is mostly done after they are on the market.
Health Canada continually monitors any relevant information which may necessitate a change to the rules.
For another, smaller, portion of food products that manufacturers would like to sell in Canada, there are mandatory premarket requirements owing to the potentially higher level of risk. Specifically, in the case of food additives, novel foods, and infant formula, Health Canada must review their safety — on a submission by submission basis — before they are allowed on the market.
Manufacturers are required to submit specific scientific and technical information in order for Health Canada to conduct a safety assessment. The department provides assistance to companies and other applicants to help them understand what is required of them by developing guidance, such as how to prepare their submissions.
Once submissions are received, they undergo a detailed premarket evaluation focused on safety, with additional considerations including quality, effectiveness and international comparability.
A similar health and safety review is of course carried out prior to making or changing a rule of general application in the regulations, such as to permit a new type or level of food fortification. Once a Health Canada review is completed, if it is determined that the product is safe or the rule is deemed appropriate, there are two possible outcomes.
In the case of novel foods or infant formulas, the applicant will receive a letter of no objection, which indicates that there are no concerns with the safety of the product. No changes are needed to the regulations to permit these products from being made available. In these instances, the approval is given for a particular product or process and is not applicable to all future products. It is not a rule of general application.
In other cases, such as permitting a new food additive or allowing certain nutrition claims on food, a regulatory change is required prior to the product being made available on the market, and the approval is applicable to all manufacturers.
As was highlighted by the vice-president of Food and Consumer Products Canada during her March 15, 2012, appearance before the committee, it is at this point that the final implementation of these decisions has traditionally been delayed by a time-consuming and resource-intensive regulatory process.
I am pleased to report today that we have addressed this concern. In line with the government's regulatory reform agenda, we strive to promote a more efficient, transparent regulatory system that is better able to respond to advances in food technology and innovations in product development, domestically and globally.
[English]
In 2012, the government took a critical step forward in modernizing the food regulatory framework, laying the foundation for important reforms through targeted amendments to the Food and Drugs Act as part of Bill C-38, the Jobs, Growth and Long-term Prosperity Act. The revisions to our food safety framework will streamline Canadians' access to safe products.
The first amendment created a new ministerial regulation called a marketing authorization, which enables the Minister of Health to act more quickly on certain safety decisions respecting substances in or on foods such as additives, and health claims. Marketing authorizations can only be used to exempt from prohibitions at the level of the act or the regulations. They cannot be used to establish new blanket prohibitions. This still requires Governor-in- Council regulations. Simply put, the new tool will reduce the time it takes for some food products and health claims to be on the Canadian market. It maintains the same scientific oversight and continues to provide opportunities for consultation with Canadians.
The second amendment provides the minister or Governor-in-Council with the authority to incorporate by reference into food regulations any document including those generated and managed by Health Canada, by other federal departments and by trusted third parties. This includes documents that may be amended from time to time. Documents can be incorporated into either a marketing authorization or into the Food and Drug Regulations themselves via a Governor-in-Council regulation. Such documents then have the force of law and are therefore enforceable.
I am happy to report that Health Canada has already utilized the new authorities provided, putting in place a modern, streamlined regulatory process for the regulation of food additives.
As mentioned previously, once Health Canada scientists determined that an additive was safe, in the past it could take many years to implement the decision through a change in the Food and Drug Regulations. These delays have limited access to innovative and safe products and hindered Health Canada's ability to respond to new scientific or safety information. Now that the food additive system has been "reset," the time to authorize a new food additive has been reduced to six months or less following completion of the scientific assessment. It is important to note that this new process does not affect the nature or rigour of the scientific assessment. Rather, the new process is faster because Governor-in- Council regulatory amendments are no longer required every time a new food additive is approved.
Once Health Canada determines that a food additive is safe and the required consultation and notifications have been completed, it is simply a matter of updating an incorporated list, which is publicly accessible on the Health Canada website. As noted earlier, these incorporated lists have the force of law.
In summary, with the new few tools, delays have been reduced, cutting red tape, and the minister and Health Canada can now act more quickly to protect health and safety, all while maintaining the integrity of the scientific decisions that are made. Building on additives modernization, the further application of these new authorities will support the government's regulatory reform agenda and strengthen Health Canada's position as a modern, sustainable, efficient and world-class regulator that is better able to respond to emerging science, to food innovation and to regulatory cooperation efforts.
[Translation]
Thank you, and I look forward to your questions.
The Chair: Thank you very much, Mr. Papadopoulos. The first senator to ask questions will be Senator Plett, who will be followed by Senator Mercer.
[English]
Senator Plett: Thank you for being here today, and thank you for that presentation. We are, of course, always competing with our friends south of the border. Many of our people here are concerned about some of the advantages that they have. As a way of guaranteeing the safety of food for human consumption, CFIA put measures in place to reduce the risk of BSE. Consequently, a list of specified risk material, or SRM, to be removed from carcasses of cattle 30 months of age or older was developed. Canadian abattoirs estimate that SRM management, as required in Canada, is different from what is required in the United States, which they say drives up the cost for Canadian abattoirs. What your opinion of that and what we can do to put us on a level playing field?
Mr. Papadopoulos: As I mentioned during my opening remarks, international comparability is very critical to our work as a standard setter at Health Canada. I am not familiar with the particular requirements you mentioned in that document from our key partner, the Canadian Food Inspection Agency, which plays a critical role, in partnership with us, in food safety in Canada. However, international review, including review of U.S. requirements, is foundational to our work when we set standards. We always look at the standards that have been set in the U.S., and in other key jurisdictions that are comparable, when making our own assessments of food safety, and those can be extremely critical to the determinations that we make. That is already built into our scientific assessment processes.
We and the CFIA are also doing a lot of work on regulatory cooperation, including with the U.S., through the Regulatory Cooperation Council, in an effort to align our food safety requirements and systems to the extent possible.
Senator Plett: I think it was my colleague Senator Buth who asked our previous witness a question in relation to why we cannot set regulations that are maybe the same. We do not simply want to do what the United States does. We need to very clearly have our own regulations and guidelines. However, our eating habits, our social habits and most of what we do here is very similar to what is done in the United States. Why would we not be able to have regulations that mirror theirs or to have theirs mirror ours? I would think that we would all have the same concerns and pretty much the same issues.
Mr. Papadopoulos: It is a good question. I do not think we would say that it is impossible to have aligned or even, in certain cases, identical requirements. In certain cases, for example with food additives, I mentioned that specific food additive levels in permitted foods would be the same in Canada and the U.S. and even in other jurisdictions like Europe, Australia and New Zealand. It is not impossible to have similar or even identical regulatory requirements in some cases. At the same time, there can be reasons to have differences in regulatory requirements. Those can be societal differences at the level of actually establishing a regulatory framework, and in the case of the scientific decision-making process there may be differences in diet that are important to account for, for example.
Senator Mercer: Mr. Papadopoulos, I want to clarify something that Senator Plett talked about having to do with the Canadian Food Inspection Agency. Is there a relationship between what you do as the Director of the Bureau of Policy, Regulatory and Governmental Affairs, Food Directorate, Health Products and Food Branch, at Health Canada and what the CFIA does?
Mr. Papadopoulos: We have a close relationship with the CFIA, both within my bureau and our directorate and overall as a department. We are key partners in lockstep on a number of different fronts.
In general, in terms of the roles, Health Canada is the standard setter, as I mentioned in my opening remarks, and the CFIA is responsible for compliance and enforcement activities around those rules. There are a lot of details, of course, around how certain responsibilities are divided, but it is actually a very close and collaborative relationship. We work very closely with CFIA on regulatory cooperation efforts with the U.S., for example, as to the Regulatory Cooperation Council.
Senator Mercer: I am pleased to see that both you and the Pest Management Regulatory Agency of Health Canada have responded to previous reports of this committee, which addressed the issue of the speed at which things are approved and the fact that this is a real concern in the agricultural sector, not just on farms but also to suppliers to the sector.
On page 8 of your report you say that now that the food additive system has been reset, the time to authorize a new food additive has been reduced to six months or less, following completion of the scientific assessment. This is good news, but tell me what it has cost us in terms of personnel? The government has told us that they have to continue to add more people to food protection, et cetera, and this is part of the network. How many more people have we had to employ to meet this six-month process?
Mr. Papadopoulos: This has not actually involved a change in staff levels. This is a change in the process of approvals, essentially. Again, once a scientific assessment has been made, it is simply a change in the process, after that point, of how we implement that change. Before, it required going all the way through a full Governor-in-Council regulatory amendment process, and now it is done through the process of updating these lists of permitted food additives found on the Health Canada website. I would not associate that with any increase in staff requirement.
Senator Mercer: We have eliminated what we have determined were unnecessary steps in the process of approval, so we are still doing the scientific work.
Mr. Papadopoulos: That is right. The scientific work has not changed. The rigour and nature of the scientific work remains exactly the same.
Senator Mercer: Once the science is done, we do not have to ask everyone and their brother for approval; we have narrowed the approval down to only a few people. Who is the final person in that chain?
Mr. Papadopoulos: The internal function for food additives is now done through senior management within the Health Products and Food Branch.
Senator Mercer: Does that person report to the deputy minister?
Mr. Papadopoulos: To the assistant deputy minister.
Senator Mercer: We have moved it up to a level just below the deputy minister.
I do not have other questions, chair, other than to say that I am really pleased to see that we are moving in this direction.
[Translation]
Senator Rivard: There are two topics I would like to discuss. I will begin with the first. You are the director of the policy bureau, and so your work is to ensure that stakeholders comply with the regulations. You must sometimes have to counsel the minister regarding improvements. I suppose that is a part of your mandate. If that is the case, I would like to point out that last week, we welcomed an eminent researcher, who informed us that a vaccine for the E. coli bacteria exists; he added that since its use is not mandatory, producers do not use the vaccine in slaughterhouses. I asked him some questions about the cost of the vaccine, but he did not have a precise idea of its cost nor of its impact on sales.
Has that problem ever been submitted to you? Do you think we could regulate in this area and force producers, when animals are being slaughtered, to administer the anti E. coli vaccine?
Mr. Papadopoulos: Yes, I have heard about that product. This is a matter that would be more in the ambit of our colleagues from the veterinary medications branch, rather than us. I can certainly follow up on that if the committee would like me to. It is not a part of my responsibilities. This does relate to food safety, but vaccines are not the responsibility of our branch.
Senator Rivard: Yes, if you could please follow up on that, we would appreciate it.
Mr. Papadopoulos: Yes.
Senator Rivard: Another point: when the food product or a cleaning product is detected by you or by the consumer as a product that should be removed — naturally, I cannot compare this with the problem of mad cow disease that we had a few years ago and the problem experienced by the XL Foods company in Alberta. The media got hold of the affair and a state of war was almost declared. But here I am talking about products I might characterize as having a minor impact. For instance, there was a case where a foaming hand soap that had been contaminated by bacteria was recalled. In such a case, I suppose that first, the department moves expeditiously to advise the supplier and the retailer who sells the product to remove it from their shelves. Then you publish public advisories in the media.
When that occurs, is it your department that decides on the scope of the notice? Is it on page 58, two lines in La Presse? In this case, it was in Montreal. How do you decide on the importance of the case and the choice of the media outlets? Are the costs shared with the producer or the distribution outlets? Could you enlighten me somewhat in this regard?
[English]
Mr. Papadopoulos: In this case, the decision on the withdrawal of products from the market would be taken by the Canadian Food Inspection Agency in their role as the enforcer. In terms of our role with the CFIA, they turn to Health Canada for health risk assessment and scientific advice on the nature, scope and size of a problem from the health and safety perspective for Canadians. They would use that information to take a risk management decision about whether it is necessary to actually recall products or whether other types of risk management decisions need to be taken.
In some cases that decision would include dissemination of information. Depending on the kind of information, that could be done by Health Canada, the Canadian Food Inspection Agency or the Public Health Agency of Canada. In some cases Health Canada puts out some kinds of information, for example relating to the safe handling of certain products. The costs would depend on the particular case. Similarly, the extent of the information and the way it is disseminated would depend on the scope of the issue being addressed.
A larger concern, such as a product in a wide-spread market, would merit a different kind of response than if the problem were contained or detected before a product actually got to market and was still in storage. That would inform the extent of the information response.
In some cases information is provided as part of a follow-up to ensure that such a problem does not happen again. For example, safe handling information around meat can be very important not only to provide information for Canadians related to a particular product or batch of products pulled off the market but also to help Canadians protect their health and safety over the long term.
[Translation]
Senator Rivard: My sole concern was about the characteristics or prominence of the notice in the media. I do not think that something like hand soap could cause death through some inadequacy in the product, but the fact remains that the population has to know. Someone brought to my attention the fact that the notice was not as prominent as it should have been, and that your organization could have been sued if people developed diseases because the notice was insufficient.
Of course, people do not expect this sort of thing to be on the front page. But it may not be sufficient for the consumer in general that there only be two or three lines at the end of a section of the paper. I understand that there are costs. But the severity of the problem also has to be considered. In the case of XL Foods, all Canadians could have purchased that product, whereas in the case of the hand soap in Montreal, it was probably not available in Vancouver. I suppose that you weigh all of these factors.
Mr. Papadopoulos: Yes, those are all important factors in these decisions. I would say, in fact, that for us and our partnership at the federal level, our priority is always the health and safety of Canadians. Our response is proportional to the scientific risks identified, and we act in consequence, aside from providing the necessary information to protect Canadians. In some cases, we certainly do work with stakeholders in the industry, for instance, to develop effective responses. Sometimes we are the ones who have important information for the industry, in order to allow it to take necessary actions in their operations to improve the situation.
Senator Rivard: I will conclude with a brief question. In the notices you publish, the producer or distributor is always at fault. Do you get them to share the cost of the public notice, is that paid for by Health Canada in its entirety, or is it shared among the various stakeholders?
[English]
Mr. Papadopoulos: I am not aware of any cost recovery for public information notices that we do.
[Translation]
Senator Robichaud: Mr. Papadopoulos, I read in your presentation that once you receive submissions, they undergo a detailed premarket evaluation focused on safety, with additional considerations including quality, effectiveness and international comparability.
Could you explain what you meant by that? You give margarine as an example and mention that there can be a supplement or something like that which means that the product contains omega-3. When you review that product, do you simply assess its safety, or do you check to see whether it really has a positive effect on the health of consumers who eat the product? Do you see where I am going with that?
Mr. Papadopoulos: The types of products and the claims we have to approve vary. Sometimes there are considerations aside from safety. To give you some examples, in the case of additives, we have to examine the effectiveness of the additive because the principles concerned involving approval and the use of additives are that they have a technical function in the product; they have to do something such as add colour. And so we do not only assess the safety of the product, but also whether the product will have the desired effect and that it is what was submitted for approval; it is necessary to prove that claim and the product must attain that objective and that technical function. That is one example regarding effectiveness.
Regarding the claims, however, there are a lot of them that do not have to be submitted to Health Canada for approval, but there are certain claims that are related to very serious conditions, such as heart health, for instance, and those claims have to be checked for approval before they can be made regarding food products.
In cases like those, we assess the validity of the claim the producer, the manufacturer, is making about his product, and we check the facts. I do not know if I have answered your question.
Senator Robichaud: Yes, but I would like to know, for instance, about the case of certain small pills about which we are told that if you take two or four a day you are much less likely to catch a cold or flu; do you check to see whether those pills really have that effect?
[English]
Mr. Papadopoulos: No. In terms of health claims specifically, only a few types of claims are subject to mandatory pre-market review. One type is actually nutrition-type claims about the nutritional content of the food and the other is health claims associated with serious disease risk reduction claims, in particular those related to Schedule A diseases in the Food and Drugs Act. That would be a claim related to heart disease but not one related to a common cold, for example.
Senator Robichaud: Would omega-3 products be examined in that light?
Mr. Papadopoulos: If there were a claim associated with them that tied in to one of those serious diseases and was making a disease-risk reduction claim associated with one of those Schedule A diseases, then yes. For example, if a claim was made that omega-3s would actually reduce your risk of heart disease, then that would be examined. A claim of omega-3s related to a cold is not subject to mandatory pre-market review by Health Canada. There are requirements at the level of the act for those kinds of claims to be truthful and not misleading and therefore must be substantiated, but they are not subject to mandatory pre-market review.
Senator Eaton: We have all been hearing about the horse meat scandal in Europe. Could this happen in Canada?
Mr. Papadopoulos: Canada's food regulatory system and food safety system, including the compliance and enforcement side, is a world-leading food safety system. It is difficult to speculate on individual kinds of problems and whether they could ever arise at any level here, but we have a very strong, world-leading food regulatory system, including many requirements in place by both Health Canada and the Canadian Food Inspection Agency. The issue of fraud and deception issues around food and the representation of food and what is in food are controlled both from a rule perspective in terms the standards found in the Food and Drug Regulations, and then of course the Canadian Food Inspection Agency is responsible for inspection and enforcement actions around those rules.
Senator Eaton: For processed food, which becoming ever larger and is now a huge manufacturing sector in Canada, is there random testing?
Mr. Papadopoulos: I am not aware of the testing regime around processed foods and when exactly random tests are carried out by the agency.
Senator Eaton: Do you think our strength, comparing ourselves a bit to the EU, is because we are perhaps more centralized?
Mr. Papadopoulos: The EU is a multi-faceted market and a multi-country market. Some of their rule system is centralized. Certainly having a single federal authority responsible for compliance and enforcement means that there is a very consistent approach brought to bear on those enforcement and compliance activities.
I also add that in all the work we do and in the work the Canadian Food Inspection Agency does, every effort is made to target resources to those areas that are required to target, to identify high-risk areas, for example, and try to devote attention to those areas. Another way of ensuring the food safety system is to try and identify those priorities.
Senator Eaton: If we complete this trade agreement with the EU, which I certainly hope we do shortly, and we enter into the TPP agreement, how will we regulate processed food coming into this country? Are you part of the technical negotiations or trade negotiations in any way?
Mr. Papadopoulos: Not me personally, but certainly our organization at Health Canada and the Canadian Food Inspection Agency are involved in the relevant portions of trade agreement discussions around sanitary and phyto- sanitary measures, for example, so for those chapters of agreements that deal with food safety and health issues, we are very much part of those discussion. I would emphasize that food imported into Canada is subject to Canadian rules, and that is the bottom line from both a standard-setting perspective and a compliance enforcement perspective. Food imported from outside Canada is still expected to meet Canadian food safety rules.
Senator Eaton: You would not be able to tell me whether there are random checks, would you?
Mr. Papadopoulos: Whether there is inspection of imported food? I would not be able to speak to the details of that regime. I know that there are checks, but I cannot speak to the specifics of that part of the inspection regime, no. It is not my area of specialty.
Senator Eaton: Is it in your department?
Mr. Papadopoulos: No, that would be the Canadian Food Inspection Agency, and of course there is a role for the Canadian Border Services Agency in terms of border-level control of food coming into the country.
Senator Callbeck: Senator Robichaud touched on this, but I want to ask about products that are sold in the health food stores to get an understanding of your responsibility in terms of the label, the content, what is in that product and what it says the product will do. For example, you referred to reducing heart attacks. Do you check into that to see that the product actually does what the label says it will do? I want to know your overall responsibility.
Mr. Papadopoulos: I will start at the overall level because you mentioned health food stores specifically. We are responsible for food products, and other parts of the Health Products and Food Branch at Health Canada are responsible for natural health products, so a different suite of products.
At one point we referred to some products as basically having been at interface between the food regulatory framework and the natural health product framework. Some products sought market access through the natural health product regulatory framework but have a history of consumption and use as foods in Canada. There has been a recent effort to actually move those food products into the food regulatory framework — one example is caffeinated energy drinks — so that they would be subject to all the rules, standards and guidelines of the food regulatory framework. Since they are perceived to be foods by Canadians and are consumed as foods as Canadians, it is important from a safety perspective and an information perspective that they be regulated as foods by Canadians. What that means, for example, is that they would have standard nutrition facts labelling and also be subject to food rules when it comes to health claims.
To focus in on your question with respect to claims, senator, it depends on the nature of the claims. Nutrient content claims, such as claims about fat content or whether a food is lean or is a high or low source of something are governed by requirements in the Food and Drug Regulations, and all foods are subject to those rules. Changes to those rules, as per my opening remarks, currently require a regulatory amendment.
Then there are health claims, that is, something to do with the health and wellness associated with a product. If those claims relate to a serious disease risk reduction claim associated with a Schedule A condition, those are subject to pre-market review. They cannot be used by a manufacturer on a food product unless they have been reviewed by Health Canada and a regulatory amendment is made accordingly.
Other claims must be truthful and not misleading, and there must be substantiation behind the truthfulness; but they do not have to submit those types of claims to Health Canada for review. That is the current structure of our health claims policy.
Senator Robichaud: You said "serious" claim. What makes it a serious claim?
Mr. Papadopoulos: There is a specific list of diseases in Schedule A, such as heart disease. A claim that implies a risk reduction in such a condition or a disease would be subject to this pre-market review. Schedule A conditions are subject to this mandatory requirement.
Senator Callbeck: You say that a claim should be truthful and not misleading. A product label may say that it will increase your energy but really has nothing to do with energy. Who looks after that?
Mr. Papadopoulos: Compliance and enforcement around our labelling and claims rules, as with the rest of the food safety and nutritional quality rules, would be the responsibility of the Canadian Food Inspection Agency. Certainly they would look into it and turn to Health Canada for advice in certain cases, for example a claim. If someone were to use a product and find that the claim on the product was not realized upon consumption of the product, they could raise that with the Canadian Food Inspection Agency and the agency could look into the product claim.
Senator Callbeck: How does the CFIA find out? Do they wait for someone to complain?
Mr. Papadopoulos: It is a mix. I am not in a good position to speak to the details of the Canadian Food Inspection Agency's activities. However, broadly speaking, there are two ways that occurs: pro-actively being out there looking for issues, and responding to complaints. Both ways are very much a part of the CFIA's and government's actions on food safety. It depends on the particular case. Certainly, they look into a complaint if they receive one.
Senator Callbeck: They are also out in the stores.
Mr. Papadopoulos: I would not be able to speak accurately to the details of their enforcement activities in these kinds of facilities. In terms of the facilities in question, the Canadian Food Inspection Agency would direct its efforts on food products and not on natural health products. The natural health products are enforced under a different regime within Health Canada from an inspection perspective.
Senator Callbeck: On page 6 you talk about that first amendment to bring in the new marketing authorization and reduce the time to six months or less. Generally, what is the time now?
Mr. Papadopoulos: Before this was brought into place on food additives, it would typically take about 18 months and in some cases could extend well beyond that. There are examples of certain food additives, including ones that have important safety benefits, for example those that deal with microbial hazards in foods, that took three to four years to implement after the safety decision.
Senator Callbeck: With this new marketing authorization, what about opportunities for consultation with Canadians, which you talk about on page 7 of your presentation? What type of consultation do you have? Is it just something put up on the website? What would be the time frame?
Mr. Papadopoulos: The amendment of a marketing authorization is still a regulation, even though it is a ministerial regulation, not a Governor-in-Council regulation, and would be subject to public and stakeholder consultation. We would have an international dimension to that as well. We have international notification requirements through the World Trade Organization. It would be a public consultation.
Certainly, Web consultation is a very important facet of our consultation today. Depending on the scope, consultations can be tailored somewhat to the scope of an issue. The exact consultation approach can vary, but posting something publicly on our website currently is a core element of our approach to consultation.
Senator Callbeck: When a new additive is to be added, you say that the time can be six months or less. I am asking about such a consultation with Canadians.
Mr. Papadopoulos: On a food additive specifically, there is a document that is incorporated by reference into a marketing authorization. That fits into the six-month process. This notice of intent to change the food additive rule would be posted on our website for a period of two months to provide the opportunity for public and stakeholder comment.
Senator Callbeck: It is for two months.
Mr. Papadopoulos: Yes.
Senator Callbeck: You mentioned that manufacturers are required to submit specific scientific technical information so that Health Canada can conduct a safety assessment and that the department provides assistance to companies. What type of assistance is that? Do they provide brochures or a list on the website as to what they have to do? Does someone help them go through this regulatory process?
Mr. Papadopoulos: We do both. We provide detailed guidance documents on the Health Canada website to assist in understanding the regime and how to make submissions. When necessary in certain cases, we will work with a petitioner to ensure that they are submitting the required information to do a proper scientific assessment.
[Translation]
Senator Maltais: Mr. Papadopoulos, in your brief, on page 2, I believe that you say that Canada establishes policies, regulations, and standards and guidelines with regard to the health and nutritional quality of all foods sold in Canada. We agree on that, but are there fish that come to us from outside the country?
You are relatively young, but I would like to remind you that in another Parliament, I put forward and had passed legislation related specifically to the Quebec and New Brunswick snow crab, in order to differentiate it from pollock, because a certain large company had decided to make imitation crab, but was selling pollock. This was unfair to the fishermen.
The same thing is happening again in Canada with a fish call tilapia, that is coming in from Asia and competing with the Eastern Canada flounder and our halibut, which is in excellent health since the seal is their predator. I have done some research on what tilapia are fed, and without going into details, if I were to explain to you what they eat, since they are a farmed product, I am not sure that you would ever eat any, and I am not sure that Canadians would eat any if there were a little sign on the package about "Tilapia nutrition." Without going into all the details, that fish, without necessarily being harmful to health, does not contain much in the way of nutrition.
I would like to know your opinion on the quality of that fish, which is unfairly competing with our fishers' products.
Mr. Papadopoulos: I am not familiar with that case or with the situation you are describing, senator. I am not really in the best position to discuss the quality of fish.
Once again, our responsibility is limited to the health and safety of food products for Canadians. What I can tell you is that fish that comes to us from offshore is subject to the same regulations and the same regulatory system that applies to other products in Canada.
Senator Maltais: I asked all the witnesses who appeared before our committee, whether from the Department of Health or another department — I spoke to everyone save for the cleaners — if someone, somewhere knew if that fish is safe for Canadians to eat. I would like to know. It is on all the shelves that display fish products in the large grocery stores, and this product is a serious competitor for our fishers. Is there someone at Health Canada, you or someone else, who could answer me? Nutritionally speaking, does that fish pose a danger to the health of Canadians who are consuming it? If you do not have the answer, could you have one forwarded in writing to the clerk of the committee?
The Chair: Could you follow up on that matter, Mr. Papadopoulos?
Mr. Papadopoulos: Yes.
[English]
The Chair: Honourable senators, we have extended our time.
Mr. Papadopoulos, thank you very much for being here. If you could follow up through the clerk of the committee on some of the questions for information, we would appreciate it.
(The committee adjourned.)