Proceedings of the Standing Senate Committee on
Energy, the Environment and Natural Resources
Issue 9 - Evidence
OTTAWA, Tuesday, May 9, 2000
The Standing Senate Committee on Energy, the Environment and Natural Resources met this day at 5:05 p.m. to examine issues relating to energy, the environment and natural resources generally in Canada.
Senator Mira Spivak (Chairman) in the Chair.
[English]
The Chairman: Honourable senators, we are pleased to have before us today representatives from the Canadian Food Inspection Agency. We are pleased for a number of reasons. One of the primary reasons is that we have received hundreds of letters from the public, letters that speak of concern about the question of food safety and, in particular, the question of genetically modified organisms.
As you know, the Standing Senate Committee on Agriculture and Forestry did a study on the bovine growth hormone. We thought we might follow up on that study, but the Agriculture Committee is very busy; they have a number of things on their plate. The committee has asked us to conduct this exploratory meeting. They have been invited here this evening, but I do not know whether any of them can attend.
Please proceed.
Mr. André Gravel, Executive Vice-President, Canadian Food Inspection Agency: We welcome the opportunity to report to this committee about the role that the Canadian Food Inspection Agency plays in environmental assessments of genetically engineered agricultural products. The CFIA plays a key role in the responsible stewardship of biotechnology as it applies to Canada's food system. With advances in science, many of the challenges we face are new. The agency itself is new, but the work that we are doing today is a continuation of a long tradition of protecting the health and safety of Canadians and the environment.
The agency's antecedents go back to the Canadian Destructive Insect and Pest Act of 1910. This act empowered the Department of Agriculture to conduct pre-import and pre-assessment of new plants imported into Canada to prevent the entry of pest organisms into the country. Each new species underwent an environmental assessment of the potential impact to the native flora and agricultural base before its import was approved. In recent years, however, the scope of such assessments has widened. The agency must now accommodate advances in breeding technology and adapt to the advent of new products derived from biotechnology.
The Canadian Food Inspection Agency also has a long history of assessing the environmental impact of other agricultural products such as supplements, feeds and veterinary biologics.
In 1993, the government approved the federal regulatory framework that established the guiding principles for regulations of biotechnology by all regulatory departments and agencies, including the CFIA. The safety assessment structure that was already in place for this function helped us to respond quickly to these challenges on new products derived from biotechnology.
The Canadian Food Inspection Agency has a presence right across Canada. It administers a regulatory system with a staff of 4,300, including specialists such as inspectors, research scientists, veterinarians and agrologists. The agency administers 185 field offices and 22 labs that provide scientific support to animal health, plant health and food-related programs.
The CFIA built upon its experience and infrastructure and then broadened its expertise to encompass products of biotechnology. They consulted with many groups to determine how to address agricultural biotechnology. In Canada, the CFIA has consulted with other departments and agencies at the federal and provincial levels, with consumers, industries and environmental associations, and with researchers and scientists.
We sought the help of the most prestigious international organizations and the best expertise from the international community, including the World Health Organization, the FAO and the OECD. As a result of these consultations, the CFIA has developed a regulatory process that is to be used in combination with its existing strong regulatory infrastructure.
I would emphasize, in particular, that we created our policies and the regulatory framework in close cooperation with Environment Canada. In 1997, we amended the regulations under the Seeds Act, the Fertilizer Act, the Feeds Act and the Animal Health Act to include the same definition of "biotechnology," and of "toxic" as contained in the Canadian Environmental Protection Act.
Let me turn next to the current process of environmental assessment. CFIA administers regulations and guidelines in four areas: plants with novel traits, novel animal feed, novel soil supplements, and novel biologics such as veterinary vaccines and veterinary test kits.
Any organism with novel traits regulated by the agency must undergo environmental evaluation prior to its import into Canada, prior to its testing in field trials, and prior to its commercialization. Let me use, by way of example, the process applied to plants with novel traits.
First, the crops are produced initially in labs and studied in growth chambers and greenhouses. They are isolated from the environment.
Second, the researcher applies for permission to conduct a confined or small-scale field trial. To do so, the researcher must apply to the Canadian Food Inspection Agency, which, under the Seeds Act, regulates crops with novel traits. The CFIA's regulatory scientists perform a pre-trial evaluation of potential risks. They then impose stringent restrictions on these field trials. The purpose of these restrictions is to confine the organisms, to limit its potential impact on the environment, and to prevent its introduction into the food and feed systems. Terms and conditions of approval include measures to prevent escape of the novel organisms under study, to prevent a genetic transfer of the traits under study to other plants, and to prevent escape to the food and animal food chain.
Third, over a number of years, field trials are carried out. During these trials, the plant and its interactions are evaluated. CFIA inspectors conduct site inspections to ensure adherence to restrictions.
Fourth, if the crop developer wants to commercialize the product, CFIA conducts another environmental safety assessment. If the crop is to be used to feed livestock, CFIA will also conduct a livestock field safety assessment. If the crop is to be used to feed humans, Health Canada carries out a food safety assessment. However, as this committee is aware, biotechnology is a rapidly advancing field; the CFIA must keep pace with the next generation of scientific discoveries.
The growth of biotechnology has challenged us to develop new ways of doing business, new teams and new expertise. Let me demonstrate this by using the largest of the four areas -- plants with novel traits.
In 1990, 78 field trials were carried out. In those early days, developers were not yet ready to commercialize novel plants. The products had not yet moved sufficiently through the pipeline. The CFIA pulled in expertise, both from within the organization and from outside the agency, for advice and expertise and formalized an expert advisory committee. We also established a special position of biotechnology officer.
As more products moved through the pipeline, it became evident that there was merit in establishing a focus where this function could be administered and the plant biotechnology office was created. By 1995, the volume of work had grown to 664 field trials. That year, the first six plants with novel traits were approved for commercial release.
I will now turn to the structure of the agency and the human resources available to us in performing our responsibilities. There is a fundamental distinction within the agency between evaluators and inspectors. Evaluators conduct all environmental safety assessments related to biotechnology products. These evaluators are highly qualified. The majority hold graduate degrees, many at the Ph.D. level. As well, new members of the evaluation teams for products of biotechnology are intensively trained and mentored.
Evaluations are also supported by specialized expertise within the agency and from outside the agency. The CFIA has established expert advisory panels to access the best available science. In the course of evaluations, experts from other departments, such as Health Canada, are consulted or participate in the review. We draw upon experts to form new teams. Biotechnology officers in the feed and fertilizer section work in concert with the plant biotechnology office and other experts in the CFIA. In addition, the feed section specialists work closely with Health Canada scientists to share information on the potential effects of novel feeds. The veterinary biologic section also has a team with diverse expertise. Each member of these sections can be called upon in the assessment of new products.
Let me summarize by saying that CFIA has adapted to the growing demands of biotechnology by creating new links, bringing in new experts, and creating new teams to provide breadth and depth to environmental assessments.
I have been speaking about evaluators. Our inspectors, on the other hand, do not conduct environmental assessments. However, they do play an important role in the environmental assessment process by ensuring that regulations for the containment of novel organisms are respected. Our inspectors are at the front line of protection for the health of Canadian food, animals and plants. They inspect plants for diseases, feeds for safety, seeds for quality and purity, and fertilizers for quality and effectiveness. They are trained to ensure compliance with Canadian laws and regulations. They enforce these laws and regulations with the support of the agency's laboratories.
The personnel of CFIA are highly trained in their respective areas, but the agency recognizes the distinct nature of novel organisms. Therefore, we give additional specific training to those who already have considerable experience and expertise. Our training includes workshops and training schools that deal with novel organisms, one-on-one training provided by the evaluator, videos on how to conduct field trial inspections, and written guidelines on inspection procedures.
Inspectors work on site. They walk through confined field trials, collecting information on the crop and on its isolation to ensure compliance with terms and conditions. Terms and conditions are tailored to the specific crop.
The number of inspectors involved in performing site inspection of field trials is shown at appendix 5 of the documents provided. More important is the fact that the CFIA is able to draw upon the talents of teams of inspectors from related disciplines within its workforce. Appendix 6 shows the budget, staff, and lab support for these functions.
The Canadian Food Inspection Agency provides the first line of defence to protect Canada's environment from potential problems associated with genetically engineered agricultural products. Our staff continues to upgrade its skills and knowledge in response to the technology.
As in all areas of regulation, we must continue to respond to changing needs. To this end, the ministers of agriculture and agri-food, environment, and health have jointly requested that the Royal Society of Canada establish an expert panel to examine future scientific development in food biotechnology and to provide advice to the federal government. In examining the leading edge of this technology, the panel will identify the possibility of new or different issues related to the safety of products of food biotechnology. It will suggest what new research, policies and regulatory capacity, if any, may need to be readied by the federal government to keep our standards of safety as high for the next generation of biotechnology derived foods as what we have for the products approved today.
Our efforts were helped greatly last February when the budget allocated a further $90 million for the regulation of novel organisms and their products. Of these funds, the Canadian Food Inspection Agency will receive an additional $30 million over the next three years. The investment in the regulatory system for biotechnology will allow us to continue to evolve and enhance our regulatory system to meet the challenges of the increasing number and complexity of products.
We will be able to hire new staff with cutting-edge expertise to evaluate the safety of new products, and train our current staff to update their skills. We will use the funding to generate research to underpin regulations. We will acquire new tools and knowledge to conduct risk assessment, risk management, and monitoring.
We will also help strengthen international regulatory cooperation and harmonization. Canada is already a recognized leader in the negotiations for international agreements and standard-setting protocols. For example, the U.S. Food and Drug Administration has recently announced mandatory notification of new products derived from biotechnology prior to marketing such products. This was already the case in Canada. In addition, the Environmental Protection Agency announced restrictions on Bt-modified plants to protect the efficacy of this natural insecticide. These measures had been adopted in Canada a full year earlier.
The Canadian Food Inspection Agency has inherited a proud legacy; one that has secured Canada the reputation of having the safest, healthiest food supply in the world. We will build on that legacy. We have been entrusted by the government with an important mission, as a steward of Canada's environment and its food supply. Biotechnology represents a new challenge to that mission. We are up to that challenge. We appreciate the support that has been given to us in the last budget, as well as the continuing interest of this committee in our work.
If you have any questions, we will be pleased to answer them.
The Chairman: Nowhere in your presentation have you given us the mandate of your agency. My understanding is that this is an agency that has both promotion and regulation as its mandate. I have read the mandate. Could you repeat it to us?
Mr. Gravel: The mandate of the Canadian Food Inspection Agency is to enhance the effectiveness and efficiency of the food inspection system in Canada.
The Chairman: I do not believe those are the words that are in the documentation. Do you have the exact words? If not, perhaps you could send us a copy of the mandate.
Mr. Gravel: I can do that.
The Chairman: I know that it does say there that part of your mandate is to promote.
Mr. Gravel: I do not think so, Madam Chairman. You are probably referring to the mission of the agency. The mission is safe food, consumer protection and market access.
Senator Cochrane: Mr. Gravel, you are forced to rely on data and the information that is supplied by producers to conduct evaluations and assessments. Is that the case, sir?
Mr. Gravel: It is one of the components that allows us to look at products that are presented for approval. This is not unusual with regard to any type of product that is submitted to the Government of Canada for approval. You will find the same situation in the approval of drugs, as an example, where the science is being assessed.
Now, to do the assessment of that science we rely on our own expertise, but we also rely on the international scientific community to determine that the data that is submitted to the agency with the submission is adequate and provides for an adequate assessment.
In cases where the evaluators are not satisfied that the data is complete and that the experiments represent a true picture of the situation, there is no approval being given. What happens in that case is that the agency goes back to the people that are making the submission for further information and further data.
If we have doubts that we have the capacity to evaluate the data, we can rely on external resources, whether they are in Health Canada, Environment Canada or international organizations such as the WHO.
Senator Cochrane: Could independent data collection be done? I know that the testing of all of this would be expensive, but could that be done? If you were given a sample of a new product each year as it comes on the market, could that be done?
Mr. Gravel: Yes, it could be done, and in some cases it is done.
Senator Cochrane: Could you be specific?
Mr. Gravel: To give you a specific example, with respect to the veterinary biologics file, new vaccines for animals, the agency conducts an assessment of the data submitted by private companies; however, we do our own testing to verify that these products are, indeed, what they are.
We can also do our own specific post-approval monitoring of products as they sit in the field to determine that they are, indeed, what they are supposed to be.
Senator Cochrane: Do you have sufficient resources? I know you were congratulating the government for supplying you with whatever was needed, but do you really have sufficient resources, both manpower and budgetary resources, to properly evaluate and assess new products?
Mr. Gravel: Certainly, the agency as well as Health Canada and Environment Canada are very pleased to have received additional resources, which will allow us to further strengthen our capacity in biotechnology. However, as I mentioned in my presentation, the agency has 4,300 staff. We have 22 labs. We have research scientists. We have evaluators and inspectors. Given the current situation, we have enough resources to handle the workload as it is now.
I am not saying that in five years, if the workload is increasing, we will be in a position to meet the challenge, but I feel that we are sufficiently equipped now to provide assessments the way they should be done.
Senator Cochrane: Has there been any delay on assessments recently or within the past couple of years?
Mr. Gravel: Which product specifically are you referring to?
Senator Cochrane: I am talking about new products that are coming on the market.
Mr. Gravel: The agency has experienced some delay in approval of veterinary biologics products, vaccines for animals. The main reason is that, first, the number of submissions has increased very significantly. Second, the complexity of each submission has also increased dramatically. The agency certainly wants to do a thorough job in evaluating submissions and making sure that all the data is provided.
The agency also has recently invested in hiring new evaluators, to decrease the backlog and cope with the current workload.
Senator Cochrane: What about the number of new genetically modified products that are coming on the market? We hear about them all the time. Are you up to par on those in regard to resources? Can you make sure there is no delay before they go on the market?
Mr. Gravel: I do not know if you have had a chance to look at the documents that the agency has provided, but you will see a graph that demonstrates the field tests that the agency is doing.
Between 1990 and 1997, the graph shows a dramatic increase in the number of products that were field-tested.
If you look at the recent years, the number of products plateaued in 1998 and it is coming down slowly. From that standpoint, it is very difficult for us to determine what the next generation of these products will be.
If the tendency continues to plateau or to go down, I think we will be okay. If, all of a sudden, there is a second generation or a third generation of new products, then we will have to see.
As I mentioned before, on the veterinary biologic side, we do have some bottlenecks that we are in the process of addressing.
Senator Christensen: After the evaluations and the approval process has been completed, what is in place for the long-term tracking of a particular product, to see that, in fact, it meets the specifications that were first set out and to determine if there are any problems through long-term use? What is in place for that?
Mr. Gravel: That is a good question. It is probably something that I did not emphasize enough in my presentation.
All the submissions that are presented to the agency for biotechnology, new products, are evaluated on a case-by-case basis.
In some cases, the evaluation is very straightforward. The expertise that we have determines that the impact on the environment is minimal, and, therefore, in that case, what we do is very limited post-approval monitoring.
In other cases, where we do have more questions about the submission itself, we can approve a product for a limited number of years and request a new submission and a new analysis of information when the period is over.
That is the way we are addressing the long-term impact on the environment.
We also monitor on a constant basis. Last year, as an example, we monitored all the confined field trials of products to ensure that they, indeed, adhere to the very strict conditions that are imposed for these limited field trials.
Senator Taylor: You must be fairly excited about this. It seems a great job in a great frontier that is opening up. Perhaps it is not a frontier, but it is certainly advancing quickly.
I want to ask about the international scene as it relates to the agency. I have attended the Codex Alimentarius in Rome and tried to do some negotiation with the Common Market. A couple of weeks ago, I visited an irrigation experimentation project in Jordan using recovered sewage water, with Canadian engineers and agrologists, using genetically engineered seeds and so on.
Having read your brief, I wondered whether you are in the position of being a police officer, given a billy club and a magnifying glass, and told to keep law and order.
There is an explosion of new products on the world scene, largely sponsored by the bigger companies. Are you trying to work out any coordination with other countries? Do you tell one country to look after a certain genetically engineered product? Do you say to the Germans, "You look after new forms of Polish or Argentine canola," or whatever it is, "and we will look after lentils"?
In other words, are you not like the little Dutch boy who tried to plug 12 holes in the dike where you have only got ten fingers with your budget? Is there world coordination? The product moves so quickly around the planet. With the World Trade Organization and free trade, there is no such thing as a real border any more.
You are puttering away with a couple of beakers and a microscope, trying to analyze the world. Am I wrong? Do you have the money? Are you coordinating your efforts with others?
Mr. Gravel: That is a very good question. Indeed, we have only 10 fingers, but we also have 10 toes.
Senator Taylor: Perhaps the politicians could use their swollen heads as well.
Mr. Gravel: I did not say that.
It is a good question. It is an area in which the agency is very actively involved. As you probably know, the Codex Committee on Food Labelling is having a session in Canada as we speak. Canada chairs that committee in the person of Dr. Anne Mackenzie. Canada was also given the lead in developing a position on the labelling of genetically modified food. We are clearly involved at that level.
Two months ago, I went to Vancouver for a meeting with colleagues from Australia, New Zealand and the U.S. We discussed how to maintain a database for tests of products of biotechnology. Canada has offered to prepare a Web site to which all countries could contribute.
As you mentioned, this field is in a great evolution. The science is evolving on a constant basis. We need to keep track of what is going on. Rather than duplicating our efforts, we need to speak to each other. We are not going as far as to assign specific products to specific countries. This is a new science. We are in the process of agreeing on how to evaluate the products, how to harmonize definitions, how to harmonize the science, and how to do risk assessments. When we are confident that we are on the same wavelength on these things, we can start farming out some of the work to other countries. We cannot do this in isolation.
We do have resources. As I mentioned, we have 22 labs. The agency is investing between $90 and $100 million per year in laboratory support. A new laboratory just opened in Winnipeg dealing with level 4 biosecurity organisms. We are not completely naked in the street vis-à-vis our own expertise, but it is important to establish linkages with international partners in this.
As you mentioned, these products are moving across borders. We must trust each other's review and evaluation system in terms of products that can potentially come to Canada.
Senator Taylor: How would you respond to a criticism that you are reinventing, in large part, the wheel? The work is already done in other parts of the world. We are giving you a big budget and keeping many people employed.
Mr. Gravel: In some cases, we are. As modest as I am, I must say that Canada probably has the best system in the world in terms of biotechnology. We were involved very early in this process in ensuring that we have adequate science and adequate regulatory safeguards. We are not, at this time, probably as confident in some of the evaluations that are done in all countries of the world. In many cases, we want to ensure that these products that are on the market in other countries also meet our stringent requirements.
Senator Taylor: You mentioned plants with novel traits. When I read your brief and documentation, I got the impression that the novel trait is related to its genetic or physical traits. It may grow tall or short or wide or be hard to eradicate. Do you try to analyze the indirect results?
The chair may have been with us in England when they complained about genetically engineered canola that could withstand herbicides and that volunteered. No one ever thought it would. The neighbouring farmers were not at all happy with the beautiful yellow weed that came in from Canada. It was safe, as far as eating and the plants were concerned.
Do you look at novel traits to see what happens if a seed volunteers or mutates into something else down the road, either physically or perhaps visually? If you have volunteer canola in your tulip bed, you would not be happy. Do you go that far?
Mr. Gravel: With your permission, I would like to ask Ms Kenny to provide some specific information about how we do these evaluations. She is a scientist; I am only an administrator.
Ms Margaret Kenny, Director, Office of Biotechnology, Canadian Food Inspection Agency: Honourable senators, we use the term "novel trait" in Canada, but you may not hear other countries talking about regulating on the basis of novel trait.
We take into consideration more than just those products that have been strictly developed through the technique of genetic engineering. You gave an example of herbicide resistance. If a particular plant was developed through a conventional means that was herbicide resistant, we would regulate it in the same way that we would if genetic engineering had been used. It would go through our process. That is not the case in many countries. In many countries, only genetically engineered crops are regulated. When we consider them in our review process, we do look at the actual method. What kind of process was used in developing it? However, the trigger to bring them in for regulatory assessment is this concept of a new or novel trait.
In terms of what we consider, there are a number of aspects that we look at in some detail. The first is the crop itself. For example, soybeans, to my understanding, have been growing in North America probably since the 1700s. What do we know about soybeans? We have gathered a lot of information about this crop. We now how it reproduces. We know things about its cold tolerance. We understand, in terms of that crop, if it could become a weed. Will it invade natural habitats, et cetera, normally? That is one thing we look at.
The next thing we look at is the new trait that has been added. The question is: Will this new trait, if it is herbicide resistance, for example, affect any of the characteristics of the plant that would have an impact on the environment? We look at the trait. We look at the trait within the plant. Then we start to look at the environmental interactions. Environmental interactions include things such as: Could this new plant become a weed of agriculture? Could it invade a natural habitat, for example? With respect to whether soybeans could cross with a wild relative, that will not happen. However, those are the kinds of questions that are asked. Those are the kinds of issues that are considered in environmental assessment.
Senator Taylor: In your environmental assessment, you have covered the physical and chemical side. Is there any allowance or input from the farmers who might say that pesticide resistance may cause some trouble, like weeds in the field? Does it allow them to save so many tonnes of herbicide per year and so many gallons of fuel as they process and prepare the land.
In other words, the product may allow me to approach zero tillage, it maintains the soil, therefore, erosion has been stopped, herbicide has been cut down that I would use on other crops. Even though this thing is not a perfect plant, it is still better than what is out there. Do you do any of that type of weighing? Are your results always absolute?
Ms Kenny: That is not part of our system, per se. We do not do those kinds of balances.
Senator Adams: The Canadian Food Inspection Agency in my area seems to operate a little differently. We eat animals that eat wild feed; we do not give them grain or hay.
We eat mostly country food, where I live. We eat wild meat. It is often difficult to buy anything from the south because it is so expensive; hence, we eat wild meat. Do you do any kinds of studies on country food and how it might be affected?
I live in the Arctic area where some of the food may be affected by pollution and environmental factors. What is your jurisdiction?
Mr. Gravel: That is an important point. Definitely the agency takes into consideration the environmental impact on other products when it approves the plant with novel traits. Associated with the approval that is given, whether it is permanent approval or temporary approval, there are conditions that farmers and the biotechnology companies must respect with regard to how that new seed will be used in the environment.
There are precautions related to basic agronomy that must be respected for any type of plant that is released into the environment. Whether it is respecting the purity of product, of certain seed characteristics that are not derived by biotechnology, or whether they are a product of biotechnology, there are basic controls that the farmers and the companies themselves are expected to meet. The agency can, at any point, go to the companies that market these products and look at the books to ensure that they are doing what they are supposed to do.
I know it is sort of at the fringe of your question, but from what I understood you to say, you may have some concerns that these new products released into the environment may have an impact on traditional types of plants.
Certainly, we take into consideration the impact that these new plants have on the habitat and the environment with regard to species of plants and animals that are restricted in numbers.
The Chairman: Our purpose in asking you to come here is really an exploratory one. We wanted to know more about the agency and its mandate. My questions deal with the regulatory framework and, more particularly, the environmental safety assessment of genetically modified crops.
The preamble of the act to establish the CFIA states that the agency is intended to contribute to consumer protection while also promoting trade and commerce. The CFIA business plan also provides evidence of your agency's mixed mandate because it says that you must facilitate market access and provide safe food and consumer protection.
My understanding is that the Canadian Food Inspection Agency was created originally so that the regulatory and promotion function within the Department of Agriculture was separated. It now seems to be continuing. Are the words I am using here wrong? Are they not in the act or in the business plan.
Mr. Gravel: I now understand your question very well. Thank you for clarifying it for me.
Keep in mind, Madam Chairman, that the Canadian Food Inspection Agency is a misnomer. The agency is not only involved in food inspection, it is also involved in animal and plant health. The agency is not involved in trade promotion activities. The agency is involved in market access activities related to products such as embryos, semen and all these things for which the agency would negotiate questions related to very specific technical considerations.
One cannot market a product that is unsafe. The activity that the agency is doing, having developed a very credible inspection system, certainly helps Canadian firms to market their own products internationally. It is recognized that these products are safe, wholesome and tested. That is what it means. The agency does not do trade promotion or trade missions to sell products.
The Chairman: I am not talking about promotion or trade. I am talking about promotion of products. You are a regulator, but you also promote products; for example, you pay for supplements in Canadian magazines. You had a pamphlet. Are you not also promoting these products as well as regulating them?
Mr. Gravel: There is no question in my mind that the agency is not in the promotion business. The agency is a regulator. As such, it is within its mandate to explain to the public in general what the regulatory system is all about.
These articles that you mention are related to factual information about how Canada's food inspection system works, about tips related to food safety and consumer education. They are not promoting any type of technology.
The Chairman: Does your stated mission talk about facilitating market access?
Mr. Gravel: As I mentioned, you must put that in context.
The Chairman: I want to know whether what I am reading is accurate.
Mr. Gravel: I am not sure what you are reading.
The Chairman: Does it say that?
Mr. Gravel: If you are reading in the preamble of the act, it is correct.
The Chairman: Again, on the regulatory framework, this is a complicated issue. I sat through CEPA and saw the trail through which functions were delegated to the Canadian Food Inspection Agency. It is a bit confusing.
Help our committee to understand which clauses of the legislation relating to seed, feed, fertilizers and the health of animals gives you the legislative authority to regulate the environmental assessment of these products. Which sections so empower?
Mr. Gravel: We can provide the information, Madam Chairman. I am sorry, I do not have copies of the act with me. However, the information will be provided to you as early as possible.
The Chairman: Will you provide us with your legislative mandate to actually do these environmental assessments?
Mr. Gravel: Indeed.
The Chairman: You seem to have a notion of an uninterrupted history of traditional biotechnology or traditional modification of plants and the new process of inserting genes into plants -- that is, transgenic, or whatever it is called.
You do not see a difference between what might be the environmental impact of traditional breeding of plants, for example, which has gone on for years, and the new implications of the genetic modifications? You do not see a distinction between traditional breeding methods and the genetically engineered methods of breeding? I am asking in terms of environmental impacts. I would be curious to know if traditionally bred crops would have unintended consequences and whether you treat them in the same way that as these new genetically engineered plants?
Mr. Gravel: That is a good question. There is no question in my mind that when you are looking at a new product, whether it is a product of biotechnology or of specific genetic crossings, the parameters to be examined for environmental assessment and impact on the food chain is the same. The product is a different product that comes from new technology, but the environmental assessment and the parameters to be measured in terms of the impact will be the same. You are looking at the possibility, as Ms Kenny said, that the plant may become a weed, that the plant may cross with other types of plants to develop characteristics that would be undesirable, and that these types of plants would be toxic to specific insects or to other populations. The types of parameters used for evaluation would be the same.
Concerning it being a product of biotechnology, the science that supports or underpins that is more complicated. Looking at these products that are now on the market, they are plant products and they are subject to the same type of environmental exposure as other products.
The Chairman: That leads me to the concept of substantial equivalent, which was first developed for assessing the safety of foods derived from genetically engineered organisms rather than for assessing the environmental impacts of genetically engineered organisms.
What is your sound scientific basis for using the concept of substantial equivalent for environmental assessment purposes in Canada?
Ms Kenny: Perhaps I could provide some clarification on that particular subject. The term is unfortunate, because it can lead to a certain amount of confusion.
In the context that we are working in the Canadian Food Inspection Agency, it means that we use, as one tool, as part of our evaluation, the concept of comparing the plant with the novel trait with what we already are familiar with.
Again, if I were to use the soybean example, I indicate that we have a certain knowledge of a soybean. If we have a plant with a novel trait, then we can start, as part of the evaluation process, looking at what is similar, and then keying in on what is different. It is not an end in itself, nor is it the complete evaluation process. It does not mean that a product is safe and it is not a substitute for a full evaluation, but it essentially embodies the concept of comparing the plant with the novel trait with the familiar crop.
The Chairman: I have not had a chance to look at your document because it just arrived. I want to look at the exact process of how you evaluate the environmental assessments.
You talked about tools. You mentioned sound crop management practices as one of the tools you used to mitigate the effects of plants with novel traits. However, sound crop management practices are not defined, nor are they a condition of authorization. Is that correct? That is to say, you do not really have a definition of what you mean by "sound crop management practices."
Ms Kenny: Perhaps I can give an example that follows from the example given by Dr. Gravel earlier. I will use the example of a corn plant or a potato with insect resistance.
There is a concern that the insect would become immune to the protection in the product. We are talking about a product obsolescence issue, in that the crop would no longer be effective in terms of controlling that pest, for example.
In that particular case, one of the conditions on approval is that the company that received the approval is required to do a couple of things. First, they must provide the growers who buy the seed with educational material on how to reduce the possibility of resistance through agricultural management techniques. That would be one example of the kind of thing we are discussing here.
In some cases, that would require the farmers to grow a certain percentage of their crop that would not be resistant to that particular insect. That is a management technique that would be involved and would be specified in the conditions that came with the approval.
The Chairman: How do you test the effect of plants with novel traits on the biodiversity of Canada? Canada has a responsibility, in signing the biodiversity convention, to protect biodiversity. How does the agency address that?
Environment Canada is familiar with that issue and their mandate was transferred to your agency.
Mr. Gravel: Expecting that your questioning would be very intelligent and deep, I took the liberty of bringing an expert on that matter with us. With your permission, I would like to bring that expert to the table.
The Chairman: Could you indicate whether you came from another department of government or from university? That would be helpful.
Dr. Stephen Yarrow, Chief, Plant Biotechnology Office, Variety Section, Plant Health and Production Division, Canadian Food Inspection Agency: I received my Ph.D. in England, and I worked for a number of years in a Toronto biotechnology company that was producing products of biotechnology, such as canola plants and potatoes, and so on. I then joined the Department of Agriculture and Agri-Food Canada, in the food inspection branch, which became part of this agency.
With respect to how to test whether a plant with a novel trait could have an impact on biodiversity, this relates to the business of the entire environmental assessment process, from when we receive the data package, which contains all the information that we require.
The Chairman: You receive that from a company?
Mr. Yarrow: Yes, from companies or a university or a public institution.
The information we require is very rigorous. We have guidelines published on our Web site. We can supply you with hard copies that will give you a general idea of the list of information we require. Most of that information addresses the questions that you are asking about the impacts on biodiversity.
We have already heard about issues such as whether a plant can become more weedy or become more invasive and therefore displace other species. We also demand information about how plants can affect other organisms, such as non-target organisms. For example, with a potato that is expressing a pesticide, an insecticidal protein, we want to know if that protein affects other insects besides the bug for which it is designed. We have to have that information, and we have to be satisfied, before we are anywhere close to being happy about authorizing these sorts of plants. that these potatoes, for example, do not affect other organisms
As an overall package of information, this is what we take into account to address your question about biodiversity.
The Chairman: If I want more specific information, that would come off the Web site, and you have that in great detail?
Dr. Yarrow: Yes.
Senator Christensen: My terminology may not be correct, but biological engineering has been going on in nature ever since time began. As hunters and gatherers, we have been using it to get species to fit our requirements of climate change or the development of bulk on cattle, among other things. Now, however, we are entering a whole new area that has no history and background. There is nothing out there against which to measure genetic engineering. Who sets the standard for that in the CFIA?
Mr. Gravel: The standard for what, senator?
Senator Christensen: For when you are getting into genetic engineering. Who sets the standard?
Mr. Gravel: If I am not answering your intended question, interrupt me and I will try to get back on track. The standard, as far as health and safety is concerned, is set by Health Canada. They set the standards that must be met before a product can be marketed, in terms of human health and safety. They are the setter of standards, and we are the enforcer. The agency's role in that context is to apply the standards set by Health Canada.
In terms of animal and plant health and these other types of activities, the agency is the standard setter and the enforcer. We have a dual role in that.
In terms of the environmental impact of new plants or animals or any other type of agricultural product, the agency sets the standard for that.
When the regulatory framework was designed, it was deemed by the department, Environment Canada, that the agency's control and regulatory powers were sufficient to exempt some of the reviews that would need to be done under CEPA from their application. In other words, they said they were satisfied that the type of environmental review done by the agency meets their requirements for an environmental review.
You mentioned something that I thought was very interesting. You said we have been "creating" new forms of plants or animals to suit our own needs. You are absolutely right. Canada would not be one of the largest wheat exporters if someone had not cross-bred wheat varieties that could survive the cold. Canada would not be one of the most successful dairy producers if someone had not crossed animals to express some traits that make these animals high producers of milk. The same thing applies for chickens. Today, we would not have chickens out on the market within a very short period of time. Biotechnology is a new way of making changes that were done in the past through trial and error. You would try crossing one breed with another breed, test it over five years, and if it did not work, you would try something else. That was through trial and error.
The new science provides the opportunity to be more focused in identifying the genes that are responsible for expressing a trait that is a desirable, and then inserting that gene in a plant -- or potentially even in an animal, although we are not there yet -- to ensure that the desirable trait is present in the animal or plant.
Senator Christensen: In the past, you had to have compatible species. We are now getting to species that are not compatible, species that you could not cross any other way except through genetics, and there is no history for that. How do we set standards to be able to evaluate those things?
Mr. Gravel: The history of our planet is such that life has evolved from a very simple life form to a multiple life form.
The Chairman: But over very many years.
Mr. Gravel: Let me finish. What you describe as something that does not make sense, crossing between species, has happened in nature and has resulted in the diversity that we have now on the planet.
Senator Christensen: And I would suggest that some of those have been the cause of some major disasters.
Mr. Gravel: The dinosaurs have disappeared, thank God.
Senator Christensen: I do not know if that was genetic crossing.
The Chairman: We have just scratched the surface. We have not absorbed everything you have told us. We do have written questions. If we send you some of those questions, could we receive answers, and then senators would have time to digest what you send to us?
Thank you for appearing. I hope you do not mind if we ask you to come back in the future.
We welcome the next witnesses. Please proceed.
Mr. Mark Winfield, Director of Research, Canadian Institute for Environmental Law and Policy: Honourable senators, our institute is an independent, not-for-profit, environmental-law-and-policy, research-and-education organization founded in 1970 as the Canadian Environmental Law and Research Foundation.
The regulation of biotechnology has always been a central element of the institute's work. We hosted the first conference in Canada on the environmental regulation of biotechnology 16 years ago in 1984. We also published a citizen's guide to biotechnology and many other publications.
The bulk of my remarks today are based on the document entitled, "The Regulation of Agricultural Biotechnology in Canada," which was published in November 1999. I understand that that document has been distributed to the committee members.
I will open with some remarks about the sources of concern with biotechnology and then I will address more specific concerns related to the regulatory regime and some of the recommendations that we have made over the years for its reform.
Agriculture biotechnology, in particular, is undergoing rapid commercialization in Canada. We have seen the commercialization of herbicide-resistant canola, corn and soya crops, and pesticide-resistant corn and potato crops. There is also rapid movement toward the commercialization of genetically engineered fish and animals and trees.
The concerns that we see around biotechnology as expressed by members of the public seem to come from three sources. The first is of an ethical and moral nature. These flow from the notion that genetic engineering constitutes some sort of violation of the laws of God or of nature, particularly the notion of crossing the species barrier. This is something with which many people have a fundamental discomfort. This a perfectly valid theological and ethical position in our view.
There is also concern over the ethical implications of higher organisms that are increasingly becoming the target of genetic engineering, such as farm animals.
There is also a general concern about whether we, as a society, have the wisdom to deal with the technology of this potential power. There always seems to be an element of hubris about certain discussions of biotechnology. This disturbs many people.
Second, the concerns about this technology arise from its potential impacts on human health and environment. Many of the impacts of genetically engineered plants and organisms were predicted by ecologists about a decade ago. In the last two or three years, the problems that were theorized are being confirmed through empirical evidence, either in experiences in the field with crops that have been commercialized or in the laboratory. The theoretical problems are now coming to reality.
As some examples, there were serious concerns about the possibility of genetically engineered plants transferring genes to wild near relatives, particularly with plants like canola, which are described by specialists as being somewhat promiscuous. We are starting to see that happening with, for example, the triple-resistant plants being found in Western Canada.
There were very serious concerns around plants modified to generate their own pesticides, the so-called Bt crops. These plants, in the process of growing, actually excrete pesticides and attempt to fight off pests in that way.
There were always concerns about the potential impacts of these types of crops on non-target species, particularly beneficial insects. Many have heard of the recent work at Cornell University about the impact of these plants on Monarch butterflies.
There were always concerns about the impact of the pesticidal plants on the actual target insects themselves. It seemed likely that, if insect populations were exposed to large doses of pesticide, resistant populations would emerge in fairly short order.
There were also concerns about human health impacts of these products, such as potential allergic reactions. The classic experiment in that regard showed that when Brazil nut protein genes were put into soya plants, allergic reactions were prompted in humans.
There have been concerns about the ubiquitous use of antibiotic-resistant marker genes in genetically engineered plants and the potential implications for the wider problems we are having with antibiotic resistance.
The third source of concern around these products, particularly in the agricultural field, is the value of this technology. In the views of my organization and that of many others, the applications do not seem to serve the interests of consumers nor to support environmentally or socially sustainable agriculture.
One must ask: Whose interests are served, for example, in modifying plants to be resistant to particular brands of herbicide? This is an example of agri-chemical companies seeking to strengthen their vertical control over the agricultural production process by locking farmers into a position of dependency in terms of seed supply and herbicide supply.
This desire for control is implicit in the technology-use agreements that farmers are asked to sign around the technology before adopting it. It is important to note, particularly with herbicide resistance, the growing body of evidence that the new traits are not reducing overall pesticide use. In some cases, pesticide use actually goes up.
More broadly, questions have been raised about the degree to which these technologies are supportive of sustainable agricultural practices. Indeed, many take the view that they respond to symptoms of deeper problems in industrial agriculture. Rather than dealing with the causes of the problems, they merely treat the symptoms.
There is also a concern particularly with the pesticidal plants, the Bt crops like potatoes and corn, that sustainable agricultural practices may be undermined by eliminating Bt in the long term as a safe and effective biological pesticide. Bt is heavily used now by organic farmers and there is a concern that, by genetically engineering plants to produce Bt toxin, plant populations will become resistant to the toxin. That will effectively eliminate Bt as an effective biological pest control.
In terms of Canada's existing regulatory framework, we have identified, over the years, a number of serious weaknesses with the existing structure. Those are laid out in our paper.
The first problem is the institutional design of the existing system. As the chair was pointing out earlier, the potential for a conflict of interest in the very mandate of the Canadian Food Inspection Agency, which is the key regulatory agency in Canada, is clearly mandated to promote consumer protection but also to promote trade and commerce.
You have seen this mixed mandate expressed in the mixing of regulatory and promotional functions by the agency. The agency is quite literally handing out regulatory decisions with one hand and literature promoting biotechnology and its benefits with the other.
The designers of the institution have forgotten the admonition of Justice Krever in his inquiry into the tragedy involving the blood system. He said that the relationship between the regulator and the regulated must never become one in which the regulator loses sight of the principle that it regulates only in the public interest and not in the interests of the regulated.
It is our concern that the food inspection agency has precisely lost sight of that principle. Indeed, the very legislation that created the agency does not reflect that principle.
Second, we have highlighted the inadequacies of the legislative basis on which the food inspection agency regulates agricultural products of biotechnology. In our view, the agricultural legislation, specifically the Seeds Act, Feeds Act, and Fertilizers Act through which the agency regulates these products, were, in our view, designed to prevent fraud and not to protect human health, the environment or biological diversity.
Indeed, if you examine the legislation you will see that it makes no reference to human health, the environment or biological diversity. When we reviewed the legislative record, we found the modern version of the Seeds Act, for example, was enacted in 1959. It is clear the purpose behind the legislation was the prevention of fraud, not the protection of human health or the environment.
We also have very serious concerns about the way in which the Canadian Food Inspection Agency has approached the assessment of the products of biotechnology. We have serious concerns about the principles of substantive equivalents and familiarity, which are essential to the process. We are concerned by the lack of an ecological or systems perspective on the assessment of products. In our view, products are evaluated in isolation from the agri-industrial systems of which they form a part.
We are also concerned about the complete reliance on industry-generated data in order to provide the basis for evaluations.
We are also concerned by the lack of independent research in Canada on the potential environmental and health impacts of these products. Scientists wishing to undertake research of that nature face some very serious barriers because virtually all of the agricultural research funding in Canada has now been arranged in way in which you must have industry partnerships in order to get funding from the granting councils. That means that it is difficult to find scientists who are not in a conflict of interest when looking at these things.
We are also concerned about the lack of an adequate accountability framework. There are no provisions for public participation in decision making, no public access to the data on which decisions are based, no more opportunity for members of the public or more specialized audiences, like university scientists, to comment on or to appeal proposed decisions.
As the Canadian Food Inspection Agency conceded earlier, there has also been a lack of follow-up monitoring on products once they are approved and released into the environment.
There are also some serious gaps in the existing regulatory framework. We note, for example, that the environmental aspects of genetically modified foods remain unregulated. Other products, such as genetically engineered fish and animals, which are approaching commercialization, continue to exist in a complete regulatory vacuum.
We also note that the system has failed to provide consumers with the ability to make choices about whether they wish to accept genetically modified foods or not because of the government's decision not to require the mandatory labelling of these products.
Over the years, we have made, as reiterated in the paper published in November, a number of recommendations for the reform of the system in light of these concerns. The first and foremost is the need to clearly separate regulatory and promotional functions among institutions with respect to biotechnology. The regulators cannot be the promoters. Such an arrangement is an invitation to disaster. We have seen that in a number of cases in the past few years in Canada.
Second, we see the need for new legislation that establishes clear and specific criteria and a process for the evaluation and approval of biotechnology products. The criteria in this legislation need to include consideration of the immediate or long-term direct or indirect harmful effects on human life or health, the environment and the conservation and sustainable use of biological diversity, including an assessment of the cumulative ecological impacts of the commercial-scale use of these products.
We also think that the legislation should require the consideration of the availability of alternative means of achieving a product's purpose, which may present lower potential for harm to the environment, human health and biological diversity.
The process for approving these products, in our view, needs to include public notice and comment periods prior to the approval of products, public access to the environmental and human health data submitted by proponents in support of applications, clear records of decisions, and appeal mechanisms to the public when they disagree with decisions made by the government for an independent assessment.
We also recommend the creation of an independent research fund to support the investigation by university researchers of the potential environmental and health impacts of genetically engineered foods and agricultural products. We note that the U.S. Department of Agriculture, for example, sets aside 1 per cent of its total budget for biotechnology specifically to fund scientists to conduct independent research on the environmental and health impacts of these products. Although a very tiny pool of funding, that has generated some of the most important science around understanding the ecological impacts of these products.
Finally, we recommend the mandatory labelling of genetically engineered foods. This, in our view, is simply fundamental to a consumer's right to choose with respect to these products.
In conclusion, we believe the current regulatory system for agricultural biotechnology products is based on a combination of institutionalized conflict of interest, deficient science and inadequate legislation. It is simply not sufficient to protect human health and the environment. Fundamental reform to the system is required.
More generally, Canadian agriculture needs to make some very difficult choices about its future with respect to genetic engineering. We have to accept the fact that we cannot force export markets to accept products they do not want, and it is clear that genetically engineered foods are not wanted in our major export markets, including the European Union and developing countries.
We will have to respond to this direction whether we agree with those decisions or not. The Canadian Wheat Board recognized this reality last fall when it decided not to move into genetically engineered wheat because of concerns about the potential impact on Canada's wheat exports.
It seems to us that we should reform the regulatory system to make it more credible, but we will also have to move toward segregation and identity preservation for genetically engineered and non-engineered crops. If we do not do so, we have the potential to lose almost all of our agriculture export markets.
More generally, we need to ask some deeper questions about how to establish an agriculture and food system that is environmentally, socially, and economically sustainable. Current federal spending on agricultural biotechnology can be estimated at approximately $100 million a year, and it seems to us that that expenditure is not moving us toward a more environmentally or socially sustainable system. We have put all of our agricultural research eggs in one genetically engineered basket, and I think we may be finding that it is the wrong basket.
Ms Ann Clark, Associate Professor, University of Guelph: I must start by saying how dumbfounded I was by the first presentation this evening. I had no idea that there were so many people and so much money involved in the CFIA. I did not know there were 4,200 people, 22 labs, and an expenditure of $90 million to $100 million a year.
The Chairman: That was extra in this budget.
Ms Clark: My understanding was that that was to pay for everything.
At any rate, two thoughts occurred to me when I heard that. I was reminded of a comment by the Dean of Architecture at the University of Virginia who said that regulations are an indication of design failure. In a very few words, that says a great deal. The more regulations we have to make to keep ourselves from killing each other too fast, the more we should be looking at the system to determine whether we are on the right path or whether we should be looking for another way by which we would need fewer regulations. If regulations are an indication of design failure, this is a failed system.
My second thought, greedy as I am, was what I could do with that much money and that many resources if they were allocated to study organic farming, grazing systems, integrated pest management, or any of the many non-propriety approaches to agriculture that could make a difference.
People often say that the fact that farmers have taken up biotechnology with such great vigour is an indication of how good it is. It is, in fact, an indication that they have no choice. The chemicals are not working. The only option that researchers are providing is biotechnology. Those are their two choices. We should be giving them the choice of ways of producing food that are not environmentally damaging, that are not harming human or livestock health, and that leave some money in their pockets.
Does anyone know how little of the farm gate value farmers retain?
The Chairman: Yes, we do know that.
Ms Clark: Seventy-five per cent of the value of what they sell goes to input suppliers. The only ones who benefit from this resource intensive agriculture, of which biotechnology is one example, are those selling the inputs. That is only farm gate, it does not extend to the processors and others.
We must think about this and not accept it as a given, that this is a "go." It need not be a go.
I commend this committee for considering the re-evaluation of the CFIA. This is a timely initiative on your part. There have been a great many advances, improvements and changes in the understanding of the risks associated with genetic engineering. When the protocols for assessing risk were set down in 1994, we did not have a clue about many of the things that have come out in the last two or three years.
A table included in my brief shows that a large proportion of the papers on issues such as gene silencing, virus recombination, and matters of that sort have been published in only the last two or three years. We did not know those risks existed when the risk protocols were set down. It is time to reconsider the way we are assessing risk to determine whether we will catch these issues. It is time to reconcile our understanding of the structure and function of the CFIA.
I have four concerns, some of which overlap those addressed by the previous speaker, so I will go through them quickly.
Of concern is the excessive power vested in the proponent, as well as the lack of transparency, the choice of parameters being used, the way the research is being conducted by the proponent and accepted by the CFIA, and the pivotal role of the substantial equivalence, which is a profoundly unscientific concept as an absolute. This is an indefensible use of this concept, yet it is the foundation of risk assessment in Canada.
With regard to the contention that the power has been ceded to proponents, there was a very interesting paper on this put out by a group of philosophers from Leiden University in Holland. They specifically assessed the way that GMOs were assessed in Holland. They made a number of quite critical comments about the illogic of a system where, first, 100 per cent of the data is provided by the proponents and, second, the proponents determine within which parameters they will provide the data. They can do this because the requirements in wording are so lax. The wording does not provide what is to be measured. It stipulates that something will be measured in a given, general category, so the choice of what will be measured is left to the proponents. This also applies to the Canadian system.
The third power that is given these people is to monitor the post-release phenomena. That is ridiculous. In this case, the fox is not simply the guardian, but the architect of the henhouse, and the operator of the security system.
This should be of real interest to you because it puts the CFIA, as an agent of the Canadian government, in the completely ludicrous position of being responsible for a system that is dominated by people who have only one interest -- a positive outcome, an approval.
This is a hazardous position for the Canadian government to be in. Who pays when something goes wrong? I do not know the answer to that question. Is the Canadian government responsible for genetic pollution, for damage to the soil in the cornfields from an accumulation of Bt, or for the loss of monarch butterflies? Who will pay? Does it go back to the industry, or does the responsibility lie with the government? If it is the government, then that means I am liable, because I am a taxpayer.
I suggest that the situation of the fox in the henhouse has evolved specifically because of the dismantling of the regulatory structure in Canada, in the U.S., in the U.K., and in many other countries in the world. The tainted blood scandal is one example of what can happen, and this is another. It is a disaster waiting to happen. I want the government to recognize that.
With regard to the lack of transparency, if you expect the Canadian public to buy into this technology, to actually believe that it is to their benefit, there must be a transparent process. Citizens must believe that this is not a secretive process, that they not being excluded, that they can see the information, participate, and appeal when they see something happening that they do not like. They need a way to buy into it, of having a sense of ownership. This is currently structured in exactly the opposite way. It is a highly secretive system. It is very much closed-loop. It is extremely difficult for people like myself to access the information that the CFIA or Health Canada has used to make their decisions.
After six months and a lot of paperwork, friends of mine did receive a copy of one submission. It cost $500. There are 43 such submissions. That is not the way to instill confidence in people. It appears as if they are hiding something. I encourage you to consider that aspect. Who benefits from such a secretive process? Do the citizens of Canada benefit when the system is so secretive? It is difficult to imagine how that can be so. If they do not, why does this continue?
My next concern has to do with the rigour of the research. I am a researcher and I have been astounded at the poor quality of science that is very evident in the one document that I have received. It is amazing, and yet not amazing. This material has never been published. It has never seen the light of day in the refereed literature. It has never been subject to peer review. It has never been given any kind of a stamp of approval of scientific quality from scientists. It has just been stamped "approved" by the CFIA. When you look at it, you know it never would be approved.
What does it mean to anyone with a scientific background to know that 12 to 15 replications were planted but only four were used? This was done at multiple sites. This does not instill a lot of confidence.
Earlier question was asked about how effects on biodiversity are assessed. If you consider what is recorded in the decision documents as being an indication that there is no risk of biodiversity, you will be astounded.
The Chairman: We were told that this information was all available on the Web site.
Ms Clark: It is on the Web site, but the only reference is to "biodiversity." I will read to you what was said about one product that was approved, that being glufosinate tolerant canola. Under "potential impact on biodiversity" it states that, "introduced genes were determined to be safe to non-target organisms." It does not say how that was determined. It gives no indication that they actually measured anything. It also states that that particular hybrid has "no novel phenotypic characteristics which would extend its use beyond the current geographic range." That is an indication that it will not affect biodiversity. The other conclusion is that "transfer of herbicide tolerance would not affect unmanaged environments." That is 100 per cent of the substance of the evidence that they accepted to conclude that there was no risk of effect on biodiversity.
There is a very weak and dubious relationship between the parameters that are accepted as indicating no risk and actual prediction of risk. It is extraordinary. I would strongly encourage you to look these up. Each decision is only two or three pages and they can be found on the Web site. The information on how to look them up is in the table in my brief. Read it for yourself and see if you find it compelling. It will be a startling exercise. I strongly encourage you to do that.
You will find that the conclusion of "no risk" involves no measurement at all. It is based entirely on assumptions: It was not intended to have a pestiferous effect, it was not intended to be a pest, therefore it is not a pest. It is almost that simple. Theoristic reasoning is prominent in all of these decision documents.
Very few measurements are made. The parameters that are chosen to be measured have a very weak relationship to prediction of anything, and this system, as it currently exists, totally missed the affect on Monarch butterflies. They now claim that they knew what the impact would be yet, starting last year, they spent $50,000 on studies at Guelph on the Monarch butterfly. That completely slipped through the radar net. There was nothing in the protocol that would have ever detected effects on anything, because no measurements are taken. Certain issues are assumed to be non-issues. As evidence of that I think you should consider why they spent $50,000 when some of what they were studying had been known and documented in the literature for decades.
As was abundantly clear in the presentation earlier this evening that the central assumption is that the intended trait is the only trait in the transgenic crops. The trait put in, whether related to herbicide tolerance or whatever, was not intended to make the crop a pest, therefore it will not be a pest. There is absolutely no recognition of the reality of unintended side effects when a transgene is inserted. I spoke about this at an earlier meeting today. I realize that most of you were not there, but we discussed this at some length. There is evidence in the literature to indicate that, when a transgene is inserted, it proceeds randomly. It is not a precise operation. You can have no idea which chromosome it will go on or where it will go on the chromosome, and order matters. It makes a difference. Whether the gene is evenly expressed has a determination on where it lands. How stably it is expressed among generations matters, depending upon where it lands, and unintended genes, other genes having absolutely nothing to do with the trait in question, get turned on or turned off simply by the process of transgenic insertion, and it is random.
Therefore, all kinds of things happen that are not even remotely thought about in the way that we are assessing risk in the CFIA protocols. This is a very important deficiency that must be rectified. I do not fault them because, in 1994, when the rules were set down, this information was not available. This knowledge has just been uncovered, but it is now time to start acknowledging the reality of the findings.
One of the five criteria that they consider in the assessment of risk is weediness or invasiveness. In the particular example I have here, they measured four parameters: vegetative vigour, that is, how well it grew; flowering interval, that is, when it started to flower and when it stopped flowering; time to maturity, that is, how long it took the seeds to mature; and seed production. That is all they measured as an indication of whether this would become a weed, whether it would become pestiferous, whether it would invade nature, and so on. Those are all useful parameters, but they are not predictive of invasiveness into the wild.
I cite the study of Purrington and Bergelson, who are evolutionary geneticists. This is their line of work. In 1995, they proposed 14 parameters that they believe should be measured. In my written brief I give you other examples of items that should be measured for each one of the five. Many things could be measured.
I am fundamentally concerned that this risk assessment system is not asking the right questions.Where is there anything about genetic pollution? Genetic pollution is a huge issue. I do not know whether you realize it, but it will essentially eliminate Western Canada from producing canola.
Canola is a Canadian crop. We spent a huge amount of money in establishing canola as a crop. We have ownership of it. We will lose canola because, even though all that money was spent on it, it is only barely a civilized plant. It is a wild plant pretending to be a civilized one. It retains many wild characteristics that are most unfavourable from an agricultural perspective, and they are deadly from the perspective of GMOs.
These characteristics include seeds not all maturing at the same time. Some mature earlier and some later. If the farmer combines his crop and sells it, he is docked for green seeds. Therefore, it is a very common practice to windrow the crop, let it dry, before combining it. The pods split open when they are mature. That is another attribute of a wild species. As a result, lots of seeds fall on the ground, and those seeds were the product of pollination in a growing season. Another characteristic is that seed can lay dormant for two to three years, unlike corn or soybeans which have been civilized to death and are very human dependent. That is about the length of time it will take you to get back to canola in your crop rotation. That means you could have doubly or triply resistant canola dormant in the soil ready to grow into your next canola crop, which is then free to pollinate and that doubly or triply resistant pollen will be distributed to other plants, pollinate them, and the cycle continues. Once it is there, it is there, and you cannot get rid of it unless you stop growing canola for an interval of time.
This is a ridiculous situation to be in. Yet, you would not guess this from anything in the CFIA's documentation. Genetic pollution is a big issue that has been completely overlooked.
The fundamental unfairness of this is striking. This is a major issue for farmers. If I decide to grow a GMO crop, should my neighbour be penalized? Should my neighbour lose his organic certification? Should my neighbour lose her GMO-free premium? Should my neighbour lose his agronomic opportunities or weed control options? Should their way of growing crops be compromised just so that I can grow a GMO crop? It is profoundly unfair. It cannot be controlled because of genetic pollution. Pollen moves. Everyone now has these very expensive genes. We are not asking these questions; and they should be asked.
What is the evidence that, when you feed genetically engineered feed to livestock, the livestock is not harmed? There is no evidence of that. I have not seen any studies on that, yet it is assumed to be a non-issue. There is no evidence of risk to livestock, but that is because the issue has not been studied. Again, we are not asking the question.
The Bt that is in Bt crops is different from the Bt that is in a foliar spray of Bt. It is different in that the substance in the soil organisms exists in a proto-toxin form. It is not active. It is not an insecticide and it does no harm to anything. In order to become harmful it must be ingested by the right insect, it must have the right pH level in the gut, and it must have the right enzyme to cleave the molecule. If all of that occurs, it becomes insecticidal and it kills the bug. Therefore, it is very selective. Only certain kinds of creatures will be affected by it. That is why it has been so useful. It also has a very short lifespan, because it is a live organism. It can be sprayed on the surface of plants and it will disappear within a week because it will be killed by UV radiation.
The same trait is genetically engineered into crops, whether it be corn, potatoes, cotton or whatever. However, what is being engineered is an active endotoxin, not the protoxin.
The Chairman: I hope you do not mind if I interrupt for a minute. Is that a good reason for assessing the process and not the product?
Ms Clark: Yes, that is one. This functionally means that, because the substance is active in every leaf of every corn plant, for example, then it has lost the selectivity that it had. Formerly, the key to the selectivity was that it was inactive when it had to be ingested. Now it is already active. There is literature showing that the selectivity of this substance is gone.
It also persists for a long time, many months, in the soil, because it gets bound to clay particles underground. The roots of Bt corn plants exude this toxin all during the growing season. It is not only when you incorporate the stuff in the fall. It is there all the time.
What effect will this have on the soil organisms, given that it is no longer selective, that it is persistent, that it retains insecticidal properties, and that it accumulates in the soil? Nowhere in the CFI protocol have they even touched on this question. We are not asking the right questions.
We have already talked about substantial equivalence. I will not go into any more depth. You have the definition of "substantial equivalence." It is a completely unworkable concept. It is impossible to try to use it in any sort of quantitative or screening way. It is really just a ruse. It is a pivotal ruse, but it is a ruse to facilitate the movement of this substance into commerce.
To illustrate that, I talk about one particular industry submission. Details of this can be found in your text. The information is from the actual submission. Five lines of potato were genetically engineered to be Colorado potato beetle resistant. Those five lines could be compared to the parent, and that is what they did. There were six food quality parameters at each of four sites, so there were 24 comparisons for each of the five lines. How many of those showed statistically significant difference? It varied among the lines. On one line there was no difference at all over any of the 24 contrasts. On another line, 25 per cent of the time they were statistically significantly different. Yet, all five lines were approved at the same time as being substantially equivalent.
My question is: How different does the item have to be before it is not substantially equivalent? Nowhere can that information be found. In fact, the issue has never arisen because everything has been found to be substantially equivalent. To my knowledge that applies to every single crop. That is a question I would have for the CFIA. It is not a screen; it is an endpoint that guarantees that these products go into commerce.
Finally, I would suggest to you that the current process is critically flawed. It is fundamentally flawed. If we are in fact going to continue on this path -- and I do not personally accept that as a given -- we must recognize that the current system relies on parameters of dubious value in predicting risk. They are essentially unrelated to risk. They are agronomic parameters: seed yield, growth, flowering, items like that. Scientific evidence related to parameters is ignored. It is in the literature. This is not rocket science.
The proponents are given most of the power. They dominate the system. They provide all the data, pick what kind of data they will give, decide which reps they will use, and so on. They rely largely on unsubstantiated or critically flawed assumptions that would never stand up in the light of day. There are no standards for replication, for how many sites will be studied, and for how many years it should be studied. This is not a meaningful system by which to assess risk. It is a system for facilitating entry into commerce.
This must change. Canadian citizens deserve better than this.
The Chairman: Thank you. There are 4,300 people working for the CFIA, some of whom are scientists. In our assessment of the rBST, which gathered us publicity all over Canada because people were so upset, we heard from a number of scientists who said, "Whoa, don't do this."
Ms Clark: Why do you think that is? How did the government respond to Shiv Chopra and Margaret Hayden and the others who spoke up? What effect did that have on the willingness of others to speak up on other issues?
The Chairman: Are you telling me you think there was a chilling effect so the scientists are now unwilling to come forward?
Ms Clark: Very much so.
The Chairman: How many scientists wrote to the Minister of Health?
Ms Clark: Two hundred. Did they listen?
The Chairman: No, they did not listen, but I am not hearing from them on this issue.
Ms Clark: As a scientist, I am fully sympathetic to why they are responding as they are. How many people like Margaret or Shiv or these other people, are brave enough to sacrifice their careers in order to tell people that something will harm them?
The Chairman: Surely within the scientific community you cannot be the only person who is pointing this out. There must be a body of people who are critical. It is difficult to draw people's attention to this issue which has the potential to be so disastrous for Canada. We hope it will not be, but it does have that potential. As the Environment Committee, we invited everyone from the Agricultural Committee to appear before us. Not one person came.
Ms Clark: If you want evidence of the number of scientists who are concerned, I would refer you to another paper I wrote, and I think you have a copy of it. It is called: "What is Sound Science."
The Chairman: I saw that.
Ms Clark: There are about 40 referreed articles in there relating to one aspect or another of these issues, whether it is pollen movement, food safety, or whatever. There are many people out there, but a person must be quite courageous to stand up and speak out.
Senator Cochrane: I must say I am impressed with the knowledge base that you have in this field. I wish you had given your presentation before we heard from our other witnesses.
The Chairman: Perhaps we should have proceeded by way of hearing from a panel of witnesses. I apologize that we did not do that. We may decided to hear from our witnesses again as a panel, because we certainly did not have an opportunity to ask our witnesses all the questions that have arisen.
Senator Cochrane: Not only did we not ask them all the questions, but I am not qualified to ask some of the questions that you have raised. I do not have your ability and knowledge base.
Are you devoting some of your efforts to lobbying people like food processors, producers and retailers on the same issues, and putting as much exuberance into your efforts as you have shown in your presentation to our committee?
Ms Clark: I do not lobby anyone. If someone calls, I come and speak. I am happy to share what I know. All of my discussions are different. There is very little repetition. I mount all those talks on my home page at the University of Guelph Web site. Everyone has access to that information. It is free, and it can be downloaded. I hold the copyright on it because I do not want to lose it, but people are free to use that information as they wish.
I am a pasture scientist. My day job is working with grass and cows, so I do this in my spare time. I have linked up with others of like mind in Canada. We are a group of about 40 academics and government scientists who critique papers and help each other.
When one of us wishes to submit a presentation such as this, the group reviews and discusses it, and that can be very beneficial. There are many people like that in the world. However, as some of you know, there is real risk involved in speaking out. The repercussions can be awful.
Senator Cochrane: It is probably worthwhile.
Ms Clark: You only have one career.
Senator Cochrane: What I am saying is: It is worthwhile considering the effects this may have on the general population.
Ms Clark: That is why I am here. I do not want my 10-year-old son to come to me in 20 years and ask: "Mom, why did you let this happen?"
Senator Cochrane: However, you must admit that there are good scientists and good people working in the department.
The Chairman: It is the leadership.
Senator Cochrane: That may be, senator, but they have consciences and surely to goodness that must count for something.
Ms Clark: I do not want to make excuses for these people, but what tends to happen is that some scientists are trained to look at issues very narrowly. I bring an ecological perspective. People of an ecological orientation see the effect, the system, the whole of thing. We are trained to look at the whole picture.
Most of the people in the department, or in CFIA, are trained to consider one only aspect, be it bugs, genes or whatever. They do not see the whole. They are not maliciously ignoring information. They just, literally, do not see it. This is a fundamental problem in the way we educate people to think.
Senator Christensen: What criteria are used to determine the level of acceptable risk? What criteria do you use?
Mr. Winfield: That is a good question to which there is no obvious answer. One must recognize that the Food Inspection Agency has never said "no" to an application for a plant with a novel trait. They have only ever imposed conditions on one, and that was after it had been improved.
There is no process or structure for answering that question. Your question is valid because, if one looks at some of the decision documents, one finds that, even within the inadequate parameters Professor Clark has described, they still identify potential problems. In the canola decisions, they admitted the likelihood of transfers to wild near relatives of genetic material, and yet they approved it.
One is left to wonder: What is the level of acceptable risk? The legislation, as it is silent even on the issue regulating from a human health or environmental perspective, provides no guidance. The policy documents are simply silent on the issue.
Thus, the risk is essentially a decision by the CFIA assessors in which there is no transparency. There are no clear criteria. There is no opportunity for members of the public to speak on what they might regard as an acceptable level of risk. That is part of the reason we see the system as being so utterly deficient.
Senator Christensen: We have heard the words, "novel trait," quite often. Is this a scientific word, or is this a bureaucratic word to make it sound soft and fuzzy?
Ms Clark: There is one thing on which I will agree with the previous speakers: Canada is unique in that we do consider plants with novel traits through mutagenesis to be naturally occurring. Some of the herbicide resistant traits are naturally occurring. They are naturally occurring mutants, thus, they breed that into a crop. That is called a plant with a novel trait, even though it was not created through genetic engineering, where you are actually taking a gene, snipping it and inserting it. Canada is unique in the world, as far as I know, in including that kind of item as a plant with a novel trait. They are assessed with the same rigour or lack thereof as genetically engineered crops. It is a term that is unique, as far as I know, to Canada and it serves their purpose.
The Chairman: We have been told that many kinds of transgenic incidents occur. My mother used to say, "A fish could marry a bird, but where would they live?" Are we disregarding the historical trends or the historical basis of evolution?
Ms Clark: That is a true statement. It is important to recognize that genes have moved amongst unrelated organisms in evolutionary history. My own DNA, and probably yours too, has a lot of alien substances in it, and we are here to live to tell about it, so everything is cool.
The difference is the issue of scale. When that happened in evolutionary time, some creature X, put a gene Y into my ancestor's DNA. It happened once for that particular connection, and it went through a whole group of screening and selection and we do not know if it was retained or screened out. Over evolutionary time, it either stayed or went, but it started at one point.
We are now taking tens of millions of hectares of land, where every cell in every plant has the same aberrant alien construct. This is an ecological affront of unprecedented proportions. This is a challenge. This is a threat to sole organisms, to beneficials, to whatever, without parallel.
It is a true statement that this has happened before, but it was at a source point source and over a great many years it has either been retained or screened out by evolution. Today it is happening on a different scale.
The Chairman: Mr. Winfield, do you have the literature on the lack or decrease in pesticide use based on the emergence of genetically engineered plants? That is the big selling point.
Mr. Winfield: I would refer you to a short but excellent paper published by the World Wildlife Fund Canada about a month ago, authored by Dr. Rod McRae. He goes through the literature thoroughly and examines both the issue of pesticide use levels and some broader questions about the relationship between genetically engineered plants and sustainable agriculture.
In regard to this issue, I raised the question of the value and the purpose of these products. The primary finding of Dr. McRae is that pesticide use levels will not go down. The core selling point with both herbicide resistance and Bt was to reduce pesticide use. The evidence he has, largely drawn on U.S. Department of Agriculture data, is that that simply is not happening.
One hears anecdotal stories about individual farmers who may well have experienced a reduction in pesticide use, but when you look at the situation in aggregate, that simply is not the case.
The Chairman: One reads all kinds of things. It is picked up and then cited as a fact.
Mr. Winfield: This is what makes this paper by WWF so important. It is brief and to the point. It clearly challenges that fundamental claim by the proponents of this technology. It is not delivering what they said it would deliver as one of its core benefits.
Ms Clark: If you look in the references in the paper I gave you, you will see the Web site address. You can look it up there. You can pull out the same tables that I pulled out, but it is most important to understand they picked the wrong crop. If their intent was to reduce insecticide use, Bt corn is the wrong example because the target pest of Bt corn is European corn bore. Only about 1 per cent to 2 per cent of all the insecticide that is applied to corn goes to control European corn bore. Even if it worked and it was reduced to zero, the effect would be so tiny that you would not see it.
What happens with Bt cotton, which is shown in the USDA data, is that the insecticide use is reduced for the target pest of Bt cotton. However, the insecticide use for the non-target pest is increased. This is a direct suggestion of secondary pest proliferation, and that is widely acknowledged.
When we apply pesticide to kill off pests, other things that did not used to be pests increase to fill the niche. They become pestiferous, which means you will need even more insecticide. That is what that USDA data show with regard to cotton.
The Chairman: You must have seen the same program that I saw on television. It had to do with a P.E.I. potato farmer who was complaining about McCain Foods Ltd. He said that where he used to do only one pass with the insecticide or herbicide, he now has to do seven or eight. He said that this was damaging not only environmentally but to his health. Do you think he was put up to making that statement?
Ms Clark: No. The way we grow potatoes in Prince Edward Island will probably shock you. It is incredibly horrible. It takes 23 passes with a tractor because you have to hill the seeds and then spray the insecticide or the herbicide. I understand that the Colorado potato beetle is only one of the insects this farmer was trying to control. He still has all the other insecticides to apply. I feel sorry for him that he cannot use Bt potatoes to control Colorado potato beetle, which is now uncontrollable with anything else because of the way we have been growing those potatoes.
The Chairman: Another question I want to ask has to do with organic farmers. When I was a member of the Agriculture Committee we had quite a few representations from organic farmers who told us that they will go out of business. You have told us that this is a huge problem, but I did not understand the extent of it.
It seems to me that people, for various reasons, including education, are now more interested in organic food than they ever were before. Is this a threat that could eliminate organic farming in this country?
Mr. Winfield: The short answer is yes -- at least that is what the organic farmers I know tell me. There are multiple dimensions to the concern. The one that I think prompted the strongest reaction was the potential for the loss of Bt as a biological pest control.
The Chairman: Pollution is also a factor.
Mr. Winfield: Yes. The other dimension is the concern of losing organic certification. Professor Clark calls that "genetic pollution." One starts to find that, even though you did not plant herbicide resistant canola, for example, you have it in your crop and you lose your organic certification as a consequence.
The flip side of this whole story is one with regard to which the committee must not lose track. We have made this rather monolithic investment in biotechnology in this particular form of agriculture. Yet, our spending is essentially zero on alternative ways to deal with the same problems, in particular organic agriculture and integrated pest management, which have the potential to provide equally, if not more effective, solutions to the problems with which we are allegedly trying to deal. If you are a farmer who wants to go down that road, then you are pretty much on your own. You hope you have a neighbour who has gone that way already and he can tell how to do it, because you will certainly not receive any help from Agriculture Canada, the CFIA, or Agriculture and Agri-Food Ontario. You will have trouble getting insurance and financing. The list goes on and on.
In contrast, other countries, in particular those in Europe, as well as a number of U.S. states, have very explicitly made decisions as part of the mix of our agricultural research funding to put money into organic agriculture.
Ms Clark: They have targets. They try to achieve a certain percentage by the year 2005, for example. It is important to recognize that the only thing that will threaten Bt corn in terms of organic farmers is sweet corn. Sweet corn is the only other crop which shares the target pest. Organic lettuce or tomatoes in this part of the world do not share European corn bore. The only crop that will be compromised, when resistance develops, is sweet corn. Similarly, genetic pollution is an issue for crops like corn or canola. It is much less of an issue -- probably a non-issue -- for soybeans, common beans and many crops like that.
There are risks which could compromise or even prevent certain crops from being grown. However, that does not necessarily mean the end of those crops. I would suggest that, in fact, it is a marvellous opportunity. Because of the lack of labelling, the only way a many people, myself included, can be sure that we will not be buying genetically engineered crops is to buy organic. I think there will be a huge demand for organic food.
The Chairman: The public interest in this issue is overwhelming. As I said before, we have received hundreds of letters, as have members of the Agriculture Committee. We would like to render a public service in this regard. We just do not know how to do it. This committee would have to adjust its priorities to do it because we are the Energy, the Environment and Natural Resources Committee. Of course, natural resources could be considered to be agricultural resources. I do not believe the Agriculture Committee, as I had thought it would, will take up this issue. One of the reasons for that is because of the very desperate state of the farm economy. Farmers do not seem to have the energy and the inclination to become involved in an issue such as this.
Do you have any suggestions as to how we could go about this? We probably could not take this up immediately. I would welcome your suggestions. This is probably one of the more serious issues facing Canadians.
Many people who want to seriously enhance their own health and that of their children want to have access to less expensive organic food. In the rBST situation, people were horrified to find that additives were being put in milk. We received letters from people who had never dreamed of writing to the Senate. I think there is some potential here for education and for a better form of agriculture. However, we could use some help.
Mr. Winfield: Earlier today, with the assistance of the Sierra Legal Defence Fund, a petition was filed with the Auditor General under the 1995 amendments to the Auditor General Act by the Canadian Institute for Environmental Law and Policy, the Council of Canadians, Professor Clark, as well as Professor Christie of the University of Prince Edward Island.
We tried to frame these issues in the submission in a way which asked a series of questions from the perspective of sustainable development and the consistency of what the government is doing regarding the principle of sustainability development, with the requirements of the Canadian Environmental Protection Act and with Canada's obligations under the United Nations Convention on Biological Diversity. That is to say, we tried to frame this issue in terms of environmental commitments that the Government of Canada has already made or entered into. In that way, we tried to frame it as an environmental issue as well as an agricultural issue. That might provide some assistance in framing a question for the committee.
The committee may want to consider a couple of other possibilities. The petition that was filed this morning focused on the regulatory system. The other issue which requires further investigation relates to the Government of Canada's spending on biotechnology. The best estimate we can make is that current federal spending on biotechnology is probably somewhere in the range of $350 to $400 million a year. That begs an investigation about the consistency of those expenditures, again in light of the principles of sustainable development. That would provide an opportunity to open the door to questions about, for example: Why is all of our agricultural research spending going into one very narrow approach?
The Chairman: Some of that money is spent strictly on promotion, not even research.
Mr. Winfield: Yes.
The Chairman: I have seen some of that information.
Ms Clark: It is important to recognize that in Europe, where they are promoting organic farming intentionally, it is often tightly linked to environmental stewardship. A good share of the funds that are listed as going to organic products is accessible to anyone, but organic farmers are the most eligible because they are so environmentally sound. The context, however, is environmental stewardship. Essentially, it is shifting support from being commodity specific to being stewardship specific. That is one area to consider.
I would also mention that when you are paying more for organic foods, that money does not go to the farmer.
The Chairman: I know.
Ms Clark: It is the retailer who has the huge mark-ups.
The Chairman: That is the other question in agriculture. I have seen the figures and know what the producer gets. We have seen that paper.
If there are no further questions, I want to thank you very much for appearing before us tonight. Would you not be adverse to returning if we were to have a panel on this subject? We have learned something here tonight and we might be better equipped to ask further questions at a later date, if senators wish to do so. Thank you again.
The committee adjourned.