EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, October 8, 1996

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[Translation]

The Chairman: Ladies and gentlemen, welcome to today's session of our Forum on biotechnology.

[English]

It is a happy day for us parliamentarians to have this unique opportunity to hold a round table with those of you who were able to come and who are not parliamentarians.

In a moment of unusual madness this committee decided to venture into the field of biotechnology, realizing, perhaps instinctively, that we were going into an area where politicians haven't easily ventured because of the complexity of the issues. However, the members of this committee and those who are not members of this committee but who are interested in this issue felt that there is a public interest at stake that needs to be examined, discussed, consulted about and put into recommendations to the government for possible action.

This is why we started this safari last May. It led to a very short report - unusually short by parliamentary standards, but very refreshing because of that - with recommendations by the end of June, and then the resumption of these discussions now.

We want to consult with the community out there. Over the summer Tom Curran, who is sitting at the table, made a number of phone calls and identified people who were willing to come to these three sessions today, of which this is the first.

The first session deals with the question of the product, process and risk of biotechnology, and it is broken down into components ranging from an analysis of recombinant DNA, the risks associated, the resources for assessment and products of biotechnology, and finally, the question of public information and education. These are the main topics related to the first workshop, which will last about two hours.

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We will start by going around the table so that people have a brief opportunity to introduce themselves, and then we will begin a discussion. Hopefully the discussion will consist of brief, crisp interventions by way of questions or answers, so that there is an intense dialogue, a quick dynamic to it, so that we can make it into a substantive and alive exchange.

Perhaps I will start with Dr. Brousseau.

[Translation]

Mr. Brousseau, do you want to say a few words?

Mr. Roland Brousseau (Group Leader, Environmental Genetics, Bio-Environment, National Research Council): Certainly. My name is Roland Brousseau. I have been a Research Scientist with the National Research Council since 1977. I have been trained as a chemist, specialized in organic synthesis. My work has to do with combining genes and I am part of a team of experts in the synthesis of recombinant organisms, mostly bacteria. I am therefore interested in this roundtable, not only from a technical point of view, but also in terms of applications and regulations in the area where I work.

[English]

Professor R. Campbell Wyndham (Director, Ottawa-Carleton Institute of Biology): I'm Campbell Wyndham and I'm at the Institute of Biology at Carleton University. I'm a researcher in microbial genetics and microbial ecology. My main interests are how recombinant and naturally occurring micro-organisms survive in the natural environment, and how they disseminate genes in the natural environment.

Mr. Knutson (Elgin - Norfolk): My name is Gar Knutson and I'm the member of Parliament for Elgin - Norfolk, which is on Lake Erie.

Mr. Forseth (New Westminster - Burnaby): My name is Paul Forseth and I'm the member of Parliament for New Westminster - Burnaby in British Columbia. I'm on the House Standing Committee on the Environment.

Mr. Howard Samoil (Staff Counsel, Environmental Law Centre (Alberta Society)): I'm Howard Samoil and I'm with the Environmental Law Centre in Edmonton. My interest is primarily in the legal relationships and the aspects dealing with the regulatory regime, as well as dealing with the adverse effects and how the public involved.

Dr. Terry McIntyre (Manager, Clean Air Technologies, Environment Canada): My name is Terry McIntyre and I'm the manager of the biotechnology advancement program at Environment Canada. Our interests are in exploring some of the more innovative environmental applications of biotechnology.

Mr. Rick Walter (Executive Director, Canadian Institute of Biotechnology): My name is Rick Walter. I'm the executive director of the Canadian Institute of Biotechnology. We're a not-for-profit organization, national in scope, that represents the vast majority of the biotechnology community, including universities, research centres and regional organizations, as well as industrial and professional associations. We're involved in technology transfer, education, communication and other areas of public awareness surrounding biotechnology.

My name is Rod MacRae. I'm the research coordinator of the Toronto Food Policy Council. My expertise is in sustainable agriculture policy development, and I'm particularly concerned with the question of whether biotechnology contributes to sustainability in agriculture.

Mr. Taylor (The Battlefords - Meadow Lake): My name is Len Taylor. I'm an NDP member of Parliament from Saskatchewan.

Mr. DeVillers (Simcoe North): I'm Paul DeVillers, the member of Parliament for Simcoe North in Ontario. I'm the parliamentary secretary to the Minister of Intergovernmental Affairs, a former member of the Standing Committee on the Environment and Sustainable Development, and a friend of the committee.

Mrs. Kraft Sloan (York - Simcoe): We need all of the friends we can get.

My name is Karen Kraft Sloan. I'm the Liberal member of Parliament for York - Simcoe. I'm also the parliament secretary to the Minister of the Environment and I'm a member of this committee.

Dr. Wilf Keller (Senior Researcher, Brassica Biotechnology, Plant Biotechnology Institute, National Research Council): My name is Wilf Keller. I'm a research scientist with the Plant Biotechnology Institute of the National Research Council of Canada. I'm located in Saskatoon. I work in the area of biotechnology of crops, particularly canola and related crops. We introduce genes into crops to make transgenic plants, and we look at the behaviour of these plants.

Mrs. Payne (St. John's West): I'm Jean Payne - not ``genes'' in the sense that Wilf just spoke about - and I'm the member of Parliament for St. John's West in Newfoundland. I'm also the vice-chair of the environment committee.

Mr. Jeff Wilson (Vice-Chair, National Agriculture Environment Committee): I'm Jeff Wilson. I'm vice-chair of the National Agriculture Environment Committee. By trade I'm a small fruit and vegetable farmer operating a 250-acre farm northwest of Toronto.

Professor Jack Trevors (Department of Environmental Biology, University of Guelph): Good morning. I'm Jack Trevors from the University of Guelph and I'm a professor of microbiology. My areas of research are genetically engineered and naturally occurring organisms and their use in the environment, and gene flow in the environment as well.

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Mr. Lincoln (Lachine - Lac-Saint-Louis): I'm Clifford Lincoln. I'm the member of Parliament for Lachine - Lac-Saint-Louis in the west island of Montreal.

Ms Chris Mitchler (Chairman, National Food Committee, Consumers' Association of Canada): I'm Chris Mitchler, chairman of the National Food Committee, Consumers' Association of Canada. We're a national voluntary organization that looks into consumer issues on a broad basis, ranging from food issues to health, insurance and banking. We're primarily interested in the way in which biotechnology will be communicated not only among stakeholders but with the public. We're concerned not only that risk assessment be science-based but that there be elements of risk management and risk communication to talk about non-health and non-safety issues.

Mr. Tom Curran (Committee Researcher): My name is Tom Curran. I'm a researcher with the research branch of the Library of Parliament. I'm assigned to this committee as a staff researcher. I'm the gentleman who made all the phone calls earlier this summer, so you've at least heard my voice if not seen my face.

The Clerk of the Committee: I am Norm Radford. I'm the clerk of the committee. I'm also the person who phoned you and wrote to you.

The Chairman: Thank you very much. We could probably start by tackling one of the more difficult questions before the committee, namely, how to assess the importance in public terms of rDNA, which is the abbreviation for recombinant DNA.

In our discussions in the spring there was an interesting dichotomy before the committee. Some witnesses took one position while others differed on whether recombinant DNA technology represents a fundamental departure from traditional biotechnological breeding or, as some witnesses said, represents an evolution in genetic technology.

For us parliamentarians that debate is of enormous importance, first of all because we have to fully understand what rDNA is all about, and secondly because we have to determine, in writing our recommendations to government, where the public interest is at stake, where the ethical considerations come into play, and if and where the existing regulatory system needs to be modified, improved or strengthened in light of not only the potential of what goes on today but the potential developments that may take place 10, 20 or 50 years from now.

Who would like to advance an opinion on recombinant DNA technology and how they see it from their perspective?

[Translation]

Mr. Brousseau: I can draw an analogy with the development of laser technology in the 1960s. It's a new technology. Prior to the 1960s, it was impossible to produce amplified light in a coherent fashion in phase. This is a technology which is not risk-free. The risks inherent to laser applications vary and go from minimal to more serious. There are now some consumer products which contain lasers, such as CD-ROM players, for music or for computer applications. These products are identified and graded according to their risk level.

The Chairman: Thank you, Mr. Brousseau.

Mr. Lincoln: I would like to ask a question to Mr. Brousseau.

[English]

As Mr. Caccia pointed out, the last time we met it seemed to us as lay people that there was a very strong dichotomy among the experts. One group of experts was saying that if you take a basic genetic risk and spin it off by adding various components and making it different, it's the same risk that carries through, and the danger doesn't seem to multiply or spread out.

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Another voice seemed to say that the minute you start to split off or play with this original gene, you might spin-off a multiplicity of risks which then make it much more complex to control, and therefore we should be much more cautious. That is what Mr. Caccia was addressing here. How far do we regulate from our standpoint? How far do we assess and where is that dividing line between a safe risk and a multiplicity of risks that is completely out of control even to the scientists, who are playing with things that are so delicate and difficult?

Dr. Brousseau: I would ask my colleagues who work on gene flow and organisms to follow up or correct after what I say. My vision is that genetic information by and large is a module that does certain tasks. A certain gene is evolved by a bacterium to kill insects. When we throw this cassette into a plant, it will still function as a device to kill insects. In my view it is not likely that this cassette would also enable the plant to live in a much drier or saltier environment. It would have functions that would impact the plant in ways that may be desirable or undesirable.

This is an over-simplification, but I think a case-by-case approach would be an answer to the assessment of biotechnology products any way the committee recommends or the government wants to add. I view genes as cassette units that have a reasonably well defined, understood function more or less regardless of the environment they may be in. However, other people may have different views on that, and people who have studied gene flow from organisms may want to comment at this point.

The Chairman: We were told that a case-by-case or product-by-product approach is less desirable than an approach that would examine the process itself. What would be the disadvantages of the alternative approach - namely, to the process - rather than to problems?

Dr. Brousseau: I think it would be much more laborious in terms of examining the process versus the product. The process may be the same whether I am viewing very safe work or very dangerous work, depending on what starting units I work with. If I work on very safe bacteria, I don't think the process for that needs to be addressed. If I work on highly dangerous contagious diseases, it is still the product of what I am trying to do that will potentially negatively impact public health or the environment. I guess I'm more a product- than process-oriented person.

Prof. Wyndham: I would agree with what you said, but I'd like to emphasize the predictability of genetic changes that have been made using recombinant DNA techniques. That's what you alluded to - that because the gene being manipulated is known, the changes to the organism are known, there is a high level of predictability as to the effect of those changes. I'm not saying it will be perfect, but it will be much more predictable than traditional biotechnologies, than the multigenic changes we've had in the past. In other words, recombinant DNA technology is a much more precise change - you've heard this before - and therefore there is much more predictability as to the effects.

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The Chairman: Mr. MacRae, please.

Dr. MacRae: I would describe myself more as a process person than a product person, if we're using that kind of demarcation.

I would agree that on one level it's a very precise technology, and then on another level it's actually very imprecise. I think it is very imprecise on an environmental level.

Perhaps I could explain that more by highlighting the difference between, say, traditional farmer-based plant-breeding programs and biotechnology.

The key, fundamental difference is that those kinds of breeding programs occur within an environmental context. So environmental factors have a profound influence on the expression of the breeding program. Therefore it's actually less risky for evaluating the environmental risks. It's easier to evaluate the environmental risks associated with the genetic expression of this breeding than with biotechnology, because biotechnology is basically the ultimate extension of a scientific process that really isolates environmental context from the breeding program.

On that level I think it's potentially much riskier to do things on a product-by-product basis. That's why the process issue is fundamental.

The Chairman: Could you provide us with specific examples rather than speaking in general terms.

Dr. MacRae: Well, for example, a lot of sustainable farmers talk about how they don't use a lot of modern plant varieties.

I've talked to a number of growers who are growing rye. They're finding that they have to go back to much older varieties, because they were bred in conditions that are much closer to the environmental conditions, the soil and climactic conditions, that exist on their farms.

When they use the modern varieties, whether they're the products of very modern plant breeding, or whether they're a step beyond and a product of biotechnology, they find that they don't function very well, and their behaviour is inconsistent in their kind of environmental conditions. So they are actually forced to go back and find very old varieties that are almost impossible to find now because nobody sells them.

The Chairman: Mr. Lincoln.

Mr. Lincoln: You were talking about efficiency and the adaptation from one setting to another, but what about risk?

Could you give us an example? Is there more risk to using biotechnology in regard to the environment and sustainable development? I think you addressed this in your remarks.

Dr. MacRae: Yes, I believe there is more environmental risk and the reasons are based in two domains. One is based on principles and theory, and one is rooted in practice. I've sort of described the practice piece.

The theoretical piece is that biotechnology is rooted in principles and science, largely the science of molecular biology, whereas sustainable agriculture is rooted in ecology: agro-ecology, ecological economics, social ecology.

These are two fundamentally different scientific approaches. Ecology, of course, is about the relationships among organisms, nutrients and water flows. It's a much more holistic, comprehensive approach to evaluating both efficiency and risk. Molecular biology is a very specific, very precise, very reductionist kind of approach to investigation, and the two don't really intersect very well.

The result is that if one takes an agro-ecological approach, you're more likely to be able to find where the downstream problems are going to be, because you're very preoccupied with all these relationship questions. Biotechnology, by its very nature, is not like that.

To give some concrete examples, of course, the critics of biotechnology have been saying for some time that there are inherent ecological risks in using these kinds of technologies. For example, some crops will be able to transfer genetic information to closely related wild relatives and create weeds that have unpredictable behaviour. Now that kind of evidence is emerging.

In fact, it is happening. I've just seen reference to a Danish study where they're now talking about how that's actually started to happen.

The reason I think these things are not foreseen in biotechnology is that it's a scientific approach that is basically incapable of making those kinds of assessments.

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Ecology is a reasonably new science, and agro-ecology is even newer, so our expertise in this area is still weak. Yet it gives us the capacity to do things that minimize downstream risks.

The Chairman: Madame Kraft Sloan.

Mrs. Kraft Sloan: Our first witness had indicated that if, for example, you wanted to make a plant more resistant to insects, it was a simple matter of taking a gene, or whatever, and that implanting it in another plant wouldn't change the plant's desirability for soil types, and things like this. If I understand what you've just said, you're suggesting that some of the newer varieties are unable to meet the current environmental conditions, and it's the older varieties that are more attuned to the current environmental conditions of the farm.

I'm hearing two pieces of information that are different, and I'm just wondering if you could explain that.

Dr. MacRae: Yes, going back to the example of insects, the genetic expression can be very precise, but the question is, how does the insect interact with the plant?

I mean, if one is concerned about solving an insect pest problem, then the real, fundamental questions are why does the insect pest exist in that particular environment; what are the environmental conditions that attract it to that particular place and that particular plant? The biotechnology solution doesn't really address that, and therefore it's likely to be a solution that will not be long term or comprehensive, and it will be costly.

The other approach is to say let's change the conditions on the farm that contribute to the growth of this insect pest and its development and population. What kind of design strategies can we put in place, what kind of crop rotations, what kinds of other competitors can we attract to the field so that in fact that particular insect doesn't have a likelihood of surviving very long in that kind of environment?

These are fundamentally issues of ecological design. I think they are the ones that lead to long-term environmental solutions, and ultimately long-term financial solutions, because they're much less costly. Once they're put in place, the farmer isn't dependent on going back to the supplier to buy the seed or the other biotechnology product they're using to solve their problem.

Does that...?

Mrs. Kraft Sloan: I'm still trying to understand why the biotechnology product doesn't address the problem, and why the biotechnology product does change in relationship to the environment that it's growing in or not growing in.

Dr. MacRae: It isn't necessarily that the plant itself will change, but the dynamic... I mean, if you have an insect problem, then you're talking not just about a plant, you're talking about an insect-plant relationship.

So the question is not so much will the plant itself necessarily change - although there is evidence that does happen - but rather, what is the relationship between the insect and the plant, and can we predict the nature of that relationship very effectively?

One of the indications, for example, that we can't predict is the development of insect resistance to both chemicals and genetically altered plants. For example, we know already that with respect to the new potato that has Bacillus thuringiensis genes inserted in it to kill the Colorado potato beetle, there is resistance in the Colorado potato beetle to this particular gene and the likelihood is that this resistance will increase. Everybody is particularly concerned about that.

But in a sense it's the cart before the horse. Having developed the product and commercialized it, we're now realizing that the relationship between the insect and the plant is such that it's going to potentially create another long-term problem, which is the effective destruction of B.t. as an effective weapon against the Colorado potato beetle.

Mrs. Kraft Sloan: So it's that the product itself is not necessarily effective as opposed to changing.... Okay, thank you.

The Chairman: Thank you. Now we have Mr. Walter.

Mr. Walter: Yes, thank you very much. There was some discussion first about the concept of genetic engineering versus traditional plant breeding. You should recognize that genetic engineering is simply a tool in the process of plant breeding. It certainly doesn't subvert or eliminate the requirement for traditional plant breeding. We are simply able to express some trait in a plant, and then we give that to the plant breeders to develop into a suitable and useful plant variety. So the plant breeding component is still taken over to actually produce a final-crop plant.

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The second thing is that an issue was brought up about a link, a tie, between the environmental risk and the use of regulation. I wanted to point out that the concept of Canadian regulation is simply based on risk. It doesn't look at process as specifically as it does look at product.

But it certainly looks at risk, no matter how the product is developed, whether it's developed through genetic engineering, traditional plant breeding, or any other mechanism. The risk of the product is what's looked at, the inherent risk of that particular product and its impact on its surrounding environment.

So the concept that the regulatory system may in fact be in question - questioning the ability of regulators to identify, verify and evaluate the risk - simply doesn't hold in this case, because that is looked at both from a genetic engineering point of view as well as from the point of view of traditional plant breeding and other mechanisms of production of crop plants.

The Chairman: By looking at it product by product, by adopting that kind of approach, which is reminiscent of looking at the forest by examining tree by tree, would you not lose sight of the totality of the forest, the general trend, and the significance of the process?

Mr. Walter: Well, I think the analogy of looking at it tree by tree is somewhat different, in that all the trees are very similar.

It would be much more like walking into a grocery store and suggesting that because of the multitude of products you can't deal with them product by product, but instead you're going to just put a single screen on all the products.

The concern there is that, first, by looking at all the products with exactly the same screen, your knowledge base may in fact be incorrect and may not be able to capture all the risks identified with each product.

On the other hand, where you are looking at it product by product, that approach is much more specific. You are able to identify risks that are inherent in one product, which may not be at all inherent in or applicable to another product.

The Chairman: Thank you.

Dr. Keller.

Dr. Keller: Thank you. I just wanted to confirm one point the previous speaker just suggested, and that is that we have to view biotechnology as an integrated component of plant variety and plant improvement. We shouldn't get the impression that it's a stand-alone technology that surpasses or replaces the way we develop new crop varieties.

I think this is something we need to look at. Biotechnology is not contradictory to crop rotation and family-farm-based business. It really should allow the grower to have more flexibility in terms of what he can plant.

Second, a comment was made about breeding and having to go back to very old varieties, of rye, for example. Generally, I think this is very untrue in that variety development in this country - and in most countries - is based on regional performance. There are regional pests.

Canola, for example, has 30 sites in western Canada where it's looked at: how it responds and how it performs in each region. In fact, the commercial development of transgenic canola fits those same guidelines.

There is a regional performance evaluation, and I think the idea of needing to go back to old varieties, because biotech somehow misses the boat, is an incorrect assumption.

We've talk a lot about DNA. I think we also need to understand that the gene is divisible. A component of that gene regulates its expression.

So if we talk about B.t. or other genes - for example, modifying oil in canola - the gene that modifies oil in canola is turned on in seed development - not in roots, not in leaves, only in the seed. So the regulation of the gene, no matter where it comes from, is under the control of systems that could already be in the plant.

So the regulation of foreign - if we want to use that word - genes involves the use of in-house regulatory systems that the plant has.

Finally, as a point of correction, it's true that a pollen can be transferred from transgenic plants to others. Pollen flow occurs in biology - there is no doubt about it - and it will flow more easily from related species.

The Danish study that was referred to dealt with the flow of pollen from canola to a weed. The canola variety of species used in Europe is called Brassica napus. In Canada we grow both Brassica napus, and another type of canola, referred to as Polish-type canola, which is Brassica rapa. In Europe, Brassica rapa is a weed; in Canada it is a crop.

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The Danish study refers to the flow of pollen from napus to rapa. In fact, that has been observed here by our canola breeders for many years, because they are very closely related crops.

They are the same crop. We grow them as canola, and we market canola seed. We don't distinguish between the two species.

Thank you.

The Chairman: Thank you.

Jeff Wilson, please.

Mr. Wilson: I have a couple of points, and I agree with Mr. Keller's comments.

What seems to be shaking out in the farm community is that this is a tool. It's not the be-all and end-all, and so I don't think we can view it in isolation, as if this is going to be the new wave of agriculture, whether it be in Canada or on a global basis.

The one thing, though, that tends to be coming through consistently from the farm community.... There is a great degree of divisiveness, both philosophical - and we'll get into that later on in the day - and also with respect to farming methodology practices. Consistency in international treatment is something that has to be a given as we formulate policy regulations here in Canada.

On the issue of varieties, let me speak as a farmer. I'm farming in an area where you wouldn't have grown grain corn 20 years ago. It's not suitable for grain corn. Ironically I'm located in southern Ontario, but I'm at a high elevation. We can't grow hot-season crops. We're now growing grain corn in my farming area because of varietal developments, new varieties.

I would argue that to say it's old versus new tends to sell short the business, ecological and environmental savvy of farmers. They will use the best variety that suits their specific farm needs.

What we certainly identified, in Ontario at least and more and more nationally as we get into the concept of environmental farm planning, is the uniqueness of every farm enterprise unto itself, because of the economic, environmental and ecological criteria of that farm.

So as we move into this, every farmer is going to view any new product release from a whole set of different standards, whether it mixes in the commodity flow they're looking for, or whether they're in a situation where they have inherent pest problems.

My farm is isolated in terms of potato production, but the reality is that all I need are three neighbours growing potatoes right alongside me, and we've created a little ecosystem where I'm going to have potato pest problems. It just tends to be an inherent situation.

So I'd also argue that one of the things we have to be cognizant of is the economic impact of agriculture as a whole, produced by a dwindling number of farmers nationally. Right now it seems to be accepted that commercial agriculture is engaged in by about 0.5% of the Canadian population.

One of the things we have to recognize is that if we're going to have fewer and fewer people producing in essence more and more agricultural output - and that's certainly the demand from a number of federal and provincial ministries that are agriculturally related - then some of these challenges are going to have to be addressed as we move down this road of sustainable agriculture.

The Chairman: So is your bottom line, then, that you see recombinant DNA as an evolution in technology and genetic technology rather than as a drastic departure from traditional biotechnology? Is that your belief?

Mr. Wilson: What we're able to determine within the agricultural community is that as opposed to revolutionary, it's more and more viewed as evolutionary.

I would give you an example. On the assumption that in the next year or two we have B.t. corn available in sweet corn - I'm a sweet corn producer - I have a window in the third week of July where I basically have the intense pest pressures from European corn borer. So I need a variety that's going to satisfy -

The Chairman: Sorry, explain that: what does it mean?

Mr. Wilson: The European corn borer is a pest inherent to all corn, especially the sweet corn varieties. The sweeter they are, the bigger the pest problem because of the aroma given off as an attractant.

In sweet corn it's not so much the economic reduction in yield; it's the physical appeal. No one wants to bite into a cob of corn with a worm or, even worse, if there's half a worm.

So essentially what I'm looking for is something that meets the demands of my customers in terms of quality, flavour, and sweetness, but also, when I have that high window of pest pressure, that maybe will help alleviate the need for the alternatives. In this case the alternatives can quite often be a chemical pesticide, whereas in the window before and in the window afterward, I don't have pressure that is nearly as intense.

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So I see a need for specific periods within my cropping system where there may be some advantage that may not necessarily be an advantage in late September. I don't have pest pressures on sweet corn in late September, so why would I look at a B.t. corn variety in late September as opposed to when the need is there?

The Chairman: Mr. Trevors, please.

Prof. Trevors: First, I think if we were to go ahead into the future, maybe even 10 years - we can't do that, but if we could do that - and if we were to look back, I think we would see genetic engineering as simply an evolution of science and technology. When we look back, I think that's what we'll see. We can't do that, but I think that will be the outcome.

Part of the problem is that biotechnology caught us off guard. It happened a little too fast. Even the scientific and regulatory communities may not have been ready for it when it sort of approached us at this fast pace.

So I think it is an evolution of science and technology. It is just progressing at a very fast pace. It's progressing at a fast pace on a global scale, and it will likely continue that way.

The second comment is that biotechnology allows us to do precise manipulations, and it doesn't have to be contrary to sustainable agriculture or sustainable environmental management.

The reason I say that is that it can be part of a larger integrated pest management program, for example. It can be part of a larger program if we have conditions on how and when the product is used and on the frequency of use of the product. A couple of examples of that have already been given around the table this morning.

So I'd just like to make those two comments.

The Chairman: Thank you. Are there any further interventions? Yes, Mr. Knutson.

Mr. Knutson: Yes, I'd would like to ask Mr. Keller and Mr. MacRae a question.

Mr. Keller, we've been getting the message, especially from the sciences, that at a genetic level organic material has much more in common than a lay person would understand. So moving genes from one organism to another, one species to another, is not really that big a deal when you look at it within the context of scientific training and understanding of science, and this worry in the community that's reflected politically is not really based on science. It's probably based on prejudice or misunderstandings that could be generated through the popular media.

Then we get another view, a stream of evidence that says no, this is really a quantum leap forward. We're talking about dealing with things that are quite radical in nature.

I think Mr. MacRae's point was that you should look at this as something quite different in terms of risk assessment, and therefore be particularly cautious because the consequences can spin out beyond your expectation.

I'd like to ask two questions. In your critique of what Mr. MacRae had said, you didn't mention this issue of whether we are entering an age of breeding super-pests every time we come out with a genetically altered species. The bugs or the insect world react far more than we might predict, and every time we're surprised by that, we risk some very serious consequences.

The other thing I'd like to ask you as a scientist is whether you think the people, when they were building the first nuclear bomb, might have thought, well, this science really just flows naturally from what we know up until now. There's no radical leap forward; it just kind of flows from our understanding of physics. Yet from a social or political point of view, the technology got way ahead of the politics and the social understanding. There weren't the regulations and political agreements in place, so we went through a long period of very high risk.

Does that analogy have any relevance at all, or is it just fear-mongering on my part?

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Dr. Keller: Thank you. I will address the first question first: are we getting into producing super-pests or ending up with some serious problems with biotechnology?

If you take a snapshot view and focus on what may be there now as specific examples - for example, B.t. - one could clearly argue that we could build up resistant insect populations.

But I think we have to look at the point that this science is evolutionary. There's ongoing research. We see the B.t. plant now, but stretching back to all the labs there is ongoing research on plant-insect interactions. What chemicals do plants produce that deter insects? How can we identify the gene products of these natural chemicals and eventually start stacking and introducing more and more genes?

Rust resistance in wheat is perhaps a good example. We had devastating rust problems in the 1930s and 1940s in the prairie wheats. And as the genetic knowledge increased and more genes for resistance were built in, it stabilized that situation. Serious losses to rust like great wipe-outs haven't occurred, to a large extent because of the building in of genetic buffering and genetic strength.

We have to view biotechnology as evolutionary. Let's use the insect examples. As we learn more about the basis of plant-insect interactions, we'll understand what goes on between that insect and plant, and we can build in solutions. This is long-term plant breeding; plant variety development is long term.

So we can't take it as a snapshot view, looking at the B.t. product that's there now, because it won't be the only product that's there now. This is going to be the beginning of a stream of products that are better from the point of view of the concerns we may see.

Mr. Knutson: May I just interject for a second? From the point of view of a regulator, politician or lawmaker, I get the point that we have 100 cases, and 99 work well. They combat it and they have this tremendous positive impact of advancement forward. All of us could look at it objectively and agree that in those 99 cases there was no inherent risk. Fine, but do you build a regulatory regime around those 99 cases? Or, if you have one case out of a hundred where you'll end up with a super-pest that does tremendous damage, how do you try to predesign your regulatory regime?

I haven't heard you say that there might not be the exceptional case of a transgenic organism that does something unpredictable that results, for example, in a super-bug. I don't use the precise language because I'm not in science, but - for lack of a better word - we end up sicker, or we've damaged ourselves environmentally, or whatever.

As a lawmaker, I would like to know where you put your focus? That's really....

Dr. Keller: That's a very important and very tough question, because of course you have to look at the benefit-to-risk ratio and use precise numbers, be it 1 in 100 or 1 in 10,000. As a researcher, I'm not sure I can give a firm number.

I think we have to move forward as a society and look at the total benefit balance. We have serious pest problems already. Can we improve these as we move forward? Maybe genetic transformation technology will help do that in some cases.

You then have to make your decision and gather your information as you go. I think, again, that it's part of an evolutionary process.

We have had problems - if I can use that word, or maybe you prefer the word ``accident'' - where over the years there have been cases of disease outbreak, and you can say it's due to monoculture. Indeed, in many cases it is, but the research has been able to address that. We must maintain a strong research base and build that knowledge into our regulatory system on an ongoing basis.

Now, I'd like to answer your second question. I think that comparing the atomic bomb to biotechnology is using the wrong comparison. The atomic bomb was intentionally built for the purposes for which it was used, and we know about the projects that were put together.

We can look at computer technology, advancing from a large monstrosity that had to be kept in a cool room, and very few people knew how to work with it, to the PCs that are sitting now in everyone's basement. I think there has been a tremendous evolution of technology there. Laser is mentioned. The automobile moved from a vehicle that barely moved to the kind of technology that's there now.

I think there are many examples of how science and technology have made very important advances - and, I would say, on the whole, beneficial advances.

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The Chairman: Mr. Brousseau, Mr. Lincoln and Mr. MacRae will speak next. Then we'll move to risks, because we are just nibbling at the edges of risk.

Dr. Brousseau: I have two points. First, as a researcher in Bacillus thuringiensis for a number of years, I certainly applaud any attempt to build these insecticides, natural or transgenic, into integrated pest management. The best solution is if the farm and the crop rotation and ecosystem can be designed so that you have zero pesticide usage, whether that's transgenic, conventional, chemical, or whatever. That's the best for the farmer and the consumer.

When this situation is not available, then there should be a look at what is available, which is with the farmer and the regulatory level. That arsenal may well, in some cases, include transgenics or other products from recombinant genetic technology.

My second point is on the product-based system. I think it may allow a better look at risk replacement. My example is of a truckload of transgenic seeds that fall into a river. In my view, it's not a really big deal. We can clean it up pretty well. A truckload of chemical insecticide on the same river could be a serious accident for human health and the environment.

So without looking at all the arguments you had on the product process, I think that by looking at the product, you can say that this insecticidal seed will replace perhaps so many tonnes of chemical pesticides. This may look positive on a risk-benefit assessment. So risk replacement is also a concept.

Mr. Lincoln: I would like to follow up on what my colleague Mr. Knutson was bringing up. I think you'll appreciate that we are lay people making regulations in a field that is highly complex. We have bear in mind that because we don't know, we have to be much more cautious than if we knew as much as you did.

Unfortunately, it's very hard for us to pinpoint what you referred to as a risk ratio. What is that safe risk ratio that will enable us to regulate safely? There's a tendency in our world today of moving so fast that the mantra is that the least regulation is best, and the more you deregulate, the happier we'll all be. The economy will flow more smoothly.

So the pressure on us, especially in the environmental field, is to deregulate as fast as possible. There are already examples of spin-offs, whereby the federal government spins off regulations to provinces, and provinces spin off to commercial or institutional undertakings and so forth, as well as municipalities. Eventually, you wonder who is accountable.

So when we talk about the risk ratio - we've been talking about pests and insects - let's talk about the direct food that impacts on people.

I know there's been the big argument as to which one is right between the Americans and us in Canada as to the breeding of chickens. Do we inject more hormones so that chickens are bred faster? What is the impact on human health?

Recently we've had a debate within our caucus about the additives to milk. Experts come and say it's as safe as anything. The United States has licensed the milk with hormone additives.

I must say that most of my colleagues I've heard are extremely cautious, because we don't know. We are just faced with a position in which we don't want to be the people who say this is safe, with a body of scientists telling us it's as safe as anything, and then find out in five years' time that it wasn't safe.

There are so many examples of things seeming to be safe, such as CFC gases. They were invented as being the safest in the world. Then we found they were perforating the ozone layer, but it was too late.

I want to ask any of you how do we make sure? If we can't make sure, do you agree that we should take the precautionary principle and keep on regulating very, very strongly until we're sure?

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The Chairman: Mr. MacRae.

Mr. MacRae: I have four quick follow-ups that I think are pertinent to Mr. Knutson's remarks, and to Mr. Brousseau's and Mr. Lincoln's as well, I hope.

One of the reasons biotechnology is such a radical departure is because it accomplishes things that in natural systems either don't occur or take so long to occur that in fact other things have occurred with them to make the genetic transformation fit into an environmental context. That doesn't happen with biotechnology.

The second point is that in some ways this question of whether it's evolutionary or revolutionary is only secondary to the fundamental question, which is, is it the right road to be on in the first place? If sustainability is about ecological design, then why aren't we putting all our scientific resources into understanding the ecology of organisms and how organisms interact? That seems to me the right road.

Then Mr. Brousseau's remarks make sense, when he says that the ultimate approach is to have a design that allows the use of these different materials to be minimized, and then you use biotechnology if you can't come up with an ecological design solution at a particular point in time. That strikes me as the context in which biotechnology could work and in which it could be regulated.

My fourth point is that one of the things a lot of people who study the history of technology are concerned about is that our technologies are becoming so much more complex and sophisticated that the potential for risk on a day-to-day basis is actually somewhat smaller than it used to be, but the potential for catastrophic risk is actually higher. So even though the odds may be down to, say, 99 chances in 100 that things will be okay, the 1 in 100 event could be catastrophic, and it would be a catastrophic event because of the technology itself.

The Chairman: Mr. Trevors, Mr. Walter and Mr. Wilson.

Prof. Trevors: I have no other comment on that.

The Chairman: Thank you. Mr. Walter.

Mr. Walter: My comments were superseded here. Thank you.

The Chairman: Mr. Wilson.

Mr. Wilson: Mr. Lincoln raised the question, do we take the precautionary principle? In essence, I as a farmer would view that as do we tend to hold back until we know?

I guess the converse of that is do you move full speed ahead, or is there some road in the middle where, through monitoring or what have you, we tend to have an ongoing analysis or update of just what is happening out there amongst the points of criteria we would establish?

I would also stress the point that we have to be consistent with what's going on. From a farm perspective, we have to be consistent with our competitors because we've also seen - to jump to another issue that's been a public contentious point for decades, the pesticide issue - that quite often we don't allow the use of a product in Canada but more than willingly import products from other jurisdictions where the product has been used. That's been particularly antagonizing to the farm community out there. We tend to regulate ourselves quite dramatically, but those outside of our jurisdiction we welcome with open arms.

We raise the issue of competitiveness and, well, we don't expect special treatment and we don't expect a regulatory framework that tends to work against Canadian agriculture and tends to support foreign agriculture in our own marketplace.

So on that point, as long as we're working consistently through whatever the numerous fora out there - the United Nations has a forum on this; the OECD process is working on fora on how we go about regulating not just this but a number of products and processes within the agricultural sector - we're very supportive of that. But we're very nervous if we say we're going to do something here that sets us adrift from the rest of the world. That's me, the farmer, saying that, as someone who also has to compete in that world marketplace.

The Chairman: This has been very helpful. We have already touched marginally upon the question of risk, and we might want to wade into it more boldly and deal with that for the next 20 minutes or so, so that we still have some time for the other two items mentioned earlier.

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I suppose that in the case of risk assessment, one of the questions this committee is wrestling with is whether the existing federal regulations and guidelines and the resources available for the regulatory assessment cover all the potential risks associated with transgenic organisms and their release. Could we have some comments on this particular aspect of risks in relation to transgenic species? Or is it something you would rather put aside for more elaborate discussions on the next item - the resources available?

Do we have any comments? Yes, Mr. Wilson.

Mr. Wilson: On the assumption that we have an idea of the risk, then it's very appropriate to communicate what those risks are. As a farmer, I'm going to make choices. When I look at an opportunity, a challenge, or a pest, or what have you, I like to know what my options are. I use the plural, ``options'', because I have a whole set of personal criteria on my individual farm that I would apply, just as my farming neighbours might have a slightly different set of criteria. I like to think I'm more environmentally oriented as a farmer and I'd like to think that influences part of my decision-making on our farm, but conversely, if my neighbour doesn't feel quite that strong, then their decision-making process is equally valid.

If there is inherent risk in any of the decisions I'm going to make, then from a farming perspective the best situation would be for me to be aware of what the risks are so that I can factor and weigh the relative risks. We all accept that life has some inherent risks in it. We walked up from the hotel here and probably went through numerous levels of risks that I wouldn't see on my normal farming operation.

The Chairman: You crossed intersections on the main square with the help of traffic lights, which are the result of a regulatory system, aren't they?

Madame Kraft Sloan, and then Dr. Keller.

Mrs. Kraft Sloan: Thank you, Mr. Chair.

I wanted to go back to something that a number of the witnesses have brought up, and it kind of relates to what this previous witness had mentioned. It's this idea of choice, and that biotechnology is only one option amongst a variety of approaches. However, I wonder if this really holds out in practice. We're often subjected to the idea of the techno-fix - that something can solve complex problems very quickly and easily for us.

One of the examples I would like to point to is rBST in milk production. A number of producers, while they did not want to use it because the jury is still out on whether it's an appropriate substance or not, felt that because of increased competition that they'd be forced into using rBST.

Also, if you take a look at some of the modern farming practices, instead of relying on other methods - rotation and different things like that - sometimes there is a high reliance on using pesticides and chemical alternatives instead of methods that are less intrusive.

I wonder if in practice biotechnology would be seen as one of many options or would become the most favoured option.

The Chairman: Dr. Keller.

Dr. Keller: Just to make a comment on this last question, I think that biotechnology would be positioned in plant improvement to be one of many options. You would look at it and implement it where it makes sense and has feasibility to address problems.

Just to raise a couple of issues in regard to the whole issue of risk and regulations, I think that - and there's been some discussion on process versus product and maybe some confusion - when we're talking of genetic engineering and introducing genes, we need to understand the gene product. In that sense, we have to look at product as well as process, and I'm not talking about commercial product now; that can be quite a different thing. Quite often the example of putting a fish gene into tomatoes has been used, and probably the media picks up on these sorts of things. In fact, many of the biotech and genetic engineering developments in agriculture will not involve those types of broad insertions. The Flavr Savr tomato, which has been given as an example, in fact has a tomato gene in it that has simply been put in in a different sequence order so it slows down the natural softening process.

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I've often been asked by the media if there is a fish gene in the Flavr Savr tomato. There's no such thing. There's an identical tomato gene in a slightly different DNA sequence, in fact in the reverse sequence. What it accomplishes is a slowing down of the natural process of ripening that's there. These are enzymes that soften the tissue.

You have to evaluate the type of gene. If you put in a foreign gene that gives you a totally different protein, then it would definitely need to be looked at much more closely in terms of risk.

I'm working in a public sector government laboratory. We've produced transgenic plants and gone to regulatory agencies to have these tested in the field. From our observation as researchers, there is quite a good system now. We have to apply for permission. We eventually may or may not receive that permission. You then have to grow the plants on a specific site. It's monitored. We've had very careful communication with the regulatory agencies. This year, for example, they phoned us half a dozen times because we didn't get an exact, detailed map to them as quickly as they needed it.

So I think there is a good system in place for dealing with plants. I think we are moving forward with that. There's always room for improvement and building that as we go along. I don't see a need for a revolutionary new system. A gene law has been proposed, I understand - that may be the subject of another round table discussion. We need to build on what we have.

The Chairman: You were addressing the area of dealing with plants. Would you address areas other than plants? Would you come to the same conclusion?

Mr. Keller: My expertise is primarily in plants, and I'm not as familiar with those types of testing. I could defer that perhaps to Dr. McIntyre or Dr. Brousseau, who deal with microbial organisms much more extensively.

The Chairman: Thank you. Mr. Walter, followed by Ms Mitchler and Mr. MacRae and then Mr. McIntyre.

Mr. Walter, would you like to comment, and perhaps include in your comments your observation as to whether - and this is a question that comes from our researcher - there are unique risks to the environment and human health from the use of recombinant DNA technology that are not present with other older technologies that have long been accepted by our society?

Mr. Walter: First I'll make a summary comment. The Canadian regulatory system already embraces the precautionary principle, which has been adequately described and embraced by this group. In every case, the precautionary principle is used as a guideline, as a fundamental, for those regulatory reviews.

In the second area that I wanted to bring up again, the regulatory system has been established to look at all risks, whether they come from genetic engineering or not. If the science risk assessment doesn't support the safety of a particular product, that product is not approved for use.

The question about whether or not the genetic engineering produces fundamentally different risks than do traditional plant breeding or animal breeding or any other mechanism for production of product has put us into a situation of new challenges. We don't yet have the full information on that, but what we are doing is dealing as best we can with trying to identify those risks, trying to work with the science community that is familiar with the gene of interest, with the plant or animal of interest, with the ecology, with the impacts on other associated and unassociated species, and attempting to identify the full range of risks that we are able to forecast.

Certainly science is never perfect, as some of the the public would like to see. Risks sometimes cannot be foreseen, but we do the best we can with all the tools that we possibly have. This may not be a perfect system, but in my view it's the best system that exists in the world today.

The Chairman: Thank you.

Chris Mitchler, please.

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Ms Mitchler: I was going to speak to the precautionary principle, which is defined here in the committee handout that I received, and it states:

In respect of all substances suspected of posing a serious threat to the environment or to human health on the basis of weight of evidence, lack of full scientific certainty shall not be sufficient reason for postponing preventive or remedial measures.

If I understand this correctly, this is saying that even if we don't have 100% certainty that there is absolutely going to be zero risk, that isn't by itself sufficient reason to say no to the technology or to say no to the product.

I think I agree with Mr. Walter when he says that we do the best we can with the knowledge and information we have. I think that's true of any technology and of any food product that is in the regulatory system for approval. I don't think it's unique just to products derived from genetic engineering. It's still subject to the same precautionary principle that there is no such thing as zero risk.

I wonder how many of you here, who have driven here in your car, still know with 100% certainty that your car is where you left it, and that it will be still there when you go to drive home tonight? I don't know that I know 100% for sure. Do I know 100% for sure that I'll get home safely without getting into an accident on the Queensway? Well, no, I don't. But I will still drive as safely as I can, and I'll take the precautions that are prudent and practical to take, and hopefully I will still get home. I suggest most of us will, too. Or, if we are going on the bus, our bus driver will.

What I'm saying is that there's no such thing as zero tolerance of risk. We base our judgments and our behaviour on the best information we have available to us. I don't think researchers are any different from that. I don't think government regulators are any exception to that. Ultimately, the government regulators are accountable to the public, and I would suggest that they are well aware of that. That in itself is another check and balance.

The Chairman: Right. This is why you have speed limits on the highway, and traffic lights within the city. This is why you have parking or other forms of fines. In other words, you invent cars, you invent planes, you invent machines and you develop the technology, but there is a point when you also have certain rules in order to reduce the risk to a minimum.

To rely only on the best possible judgment of the individual is sometimes not good enough from the perspective of the public interest. That is why you have all these additional precautions such as the speed limits and the traffic lights, which may be an inconvenience. That's why Mr. Wilson got to the Hill this morning safely. He could cross the street without having to run like a rabbit ahead of the next car. While the red light may be an inconvenience, it's still better than blood all over the place at the intersection, right?

Mr. MacRae.

Dr. MacRae: Thank you, Mr. Chair. To follow on your remarks, I would say given that a number of people here have said that the real place of biotechnology is as a subset of a larger strategy that deals with larger ecological design issues, it strikes me that this will only happen if the regulatory system is in place to ensure that it does happen that way.

The commercial pressures to produce - the international pressures that Mr. Wilson has referred to - will drive us, I think, toward a place where biotechnology is seen as predominant, unless the regulatory framework ensures that it does occupy its place as a subset of a larger ecological strategy.

I think the other related issue is that the precautionary principle requires a precautionary science. Ecology is a precautionary science. Health promotion is a precautionary science. I would argue that the regulatory system we have in place is not rooted in those kinds of precautionary sciences. Therefore, the capacity of the regulatory system to be precautionary is limited.

The Chairman: Limited to what?

Dr. MacRae: It's limited because we don't have the scientific tools; we don't use the tools that are currently available to evaluate a precautionary approach, to use a precautionary approach.

The Chairman: Can you give us an example?

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Dr. MacRae: Again, if the issue of ecological risk is predominant, then a regulatory apparatus wouldn't ask, for example, if this transgenic product that controls pests is safe. Even before engaging in the question of whether this product should be allowed on the market, it would first say have we looked at all the ecological strategies and promoted those, and have we used the regulatory apparatus to promote those?

So basically the regulatory system doesn't ask those larger questions. The issue of rBST was raised earlier. There is nothing in the regulatory system that requires the really large questions to be asked. These are questions such as what the real benefit of this product is. Who benefits from it? What kind of structural implications does it have for Canadian agriculture, including environmental, social and economic implications?

The regulatory apparatus doesn't require that those questions be asked. Instead, it deals with much more technical issues, which are not necessarily precautionary in nature. To some degree they are; to some degree they're not.

The Chairman: Thank you.

Madame Kraft Sloan.

Mrs. Kraft Sloan: I would like to add that a lot of the benefits are more economic benefits and have to do with economic efficiency versus economic effectiveness. When we talk about efficiency we leave out the sustainable aspect.

The question I would like to put on the table is that if ecological approaches, agro-ecology or what have you, are an emerging discipline, do we then have the resources in the country to properly do impact and risk assessments based on these principles? I'm wondering if the witnesses would care to comment on this.

The Chairman: Mr. McIntyre.

Dr. McIntyre: Ms Mitchler has more or less addressed the concerns that I had on the risk assessment side.

The Chairman: Mr. Wilson.

Mr. Wilson: There are two points. One is on the issue of the systems and the other is the issue of the techno-fix. I would like to respond in the context of where we feel they do come around to the economic side.

The analogy I would give is that we have fairly effective, stringent pesticide regulations in Canada. These are the way we license and allow pesticides for use by agriculture, forestry and what have you. But does that mean that if I'm a farmer and I use them to the fullest legal ability - I'm complying with the law and complying with the regulations - I am complying either with my economic criteria or my own personal environmental criteria? Generally the answer is no. There are various systems starting to emerge in Canada among farmers. Integrated pest management is certainly one of them. Even in the organic sector, some of the production methodologies they're advocating have a lot of merit. They have a lot of merit in terms of how we work more closely at identifying what the issue is and what is the most effective way to deal with them. At times I use the word ``effective'' as opposed to strictly economic.

I would also argue that as we move into this integrated approach to production agriculture, the range of options is something farmers are taking quite seriously because there is a whole range of philosophies behind the decision-making process. They're all valid.

You're right. There are economic ties. We cannot ignore them. We would be fools to ignore them. As we move ahead economically, do I have a better chance to thrive, as it were, by basing my future on higher prices for agricultural production or gaining efficiency on my farm input side? This could be a rise in the actual production volume or a reduction in my cost of producing whatever I'm producing.

The farmer in me and my limited expertise as a business person, especially from the scientific side, tell me I should focus on how I go about producing my crop as opposed to hoping at the end of the day the consumers of Canada or elsewhere will pay more for that production. We've made strident gains on my personal farm, and this is information that tends to be coming out collectively. By following an integrated pest management approach, I'm reducing my pest management costs by 20% or 30% - it varies from year to year - because the decision-making is not mine alone. I'm adding more of the scientific interpretation at the farm level as to how I go about managing my farm business, which, quite honestly, I don't personally have the expertise to do.

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The Chairman: Mr. Knutson, followed by Mr. MacRae.

Mr. Knutson: [Inaudible - Editor] to Mr. Wilson.

Mr. Keller, you indicated that rearranging a gene of a tomato plant - I don't want to put words in your mouth - is inherently different from taking a gene from a fish and putting it into a tomato. Some scientists - microbiologists - have suggested that it's not. Genes are genes. Sometimes they're the same in different organisms, and sometimes they're not.

I am curious, as we might be starting to lay down criteria, whether a new gene act or some other piece of legislation states that there are times when this is radically different and we need to take a longer look and that there are times when it's simply incremental technology or incremental.... I wondered whether you might expand on that for me. Can we lay out criteria ahead of time stating that this should go through a tougher regulatory process than something else?

Dr. Keller: I was making my comments in relation to the whole area of assessment of risks with transgenic organisms. The technology for introducing the tomato gene back into a tomato or introducing a fish gene, as we used as an example, would be the same, maybe identical, but the new product - the new protein - in the tomatoes would be quite different. Therefore, you're asking whether we now have different criteria. I think we already have taken that into account.

When we submit for testing of these plants, for example, there are already requirements to identify what the gene is, what the protein product is, and based on what. If this is a novel product in the system, there's going to be more stringent testing, at both the environmental and the food level, than there would be if it were another canola gene put into canola. So I think we're on that road.

The Chairman: Thank you. We'll have brief interventions by MacRae, Samoil, and Trevors. Then we'll move on to resources.

Dr. MacRae: Thank you, Mr. Chair. I would like to quickly respond to Mrs. Kraft Sloan's inquiry.

The government has a very fundamental role to play in promoting agro-ecology as a scientific discipline. The reason is that agro-ecology is less commercially palatable than, for example, biotechnology.

Biotechnology is a science that produces very identifiable commercial products that can be sold in the marketplace and have the potential to create customer dependence on them in order to sustain the market.

Agro-ecology as a science is much more concerned with how you use design and management procedures and how farmers use their own knowledge and the wisdom they acquire from people they collaborate with to make themselves more self-reliant and less dependent on the purchase of commercial products and, I hope, therefore more financially sustainable in the long run. Unless the regulatory system and government promote agro-ecology as a scientific discipline, it will be ignored by the marketplace.

The Chairman: Thank you. Mr. Samoil.

Mr. Samoil: It seems to me that the risks really have two components. One is the risk associated with the variability that's there. But there's also a risk associated with the lack of knowledge.

I think the regulatory system has an adequate capability to deal with the variability in what we know and what exists out there, but it's poorly equipped to deal with the risks that come from the lack of knowledge. The problems we have in Alberta with cumulative risks and with trying to assess the cumulative impacts of a release are in areas in which there is a lack of knowledge. I don't think the resources are there, and I'm not quite certain that the precautionary principle as it's stated really deals with that lack of knowledge and in how you incorporate that lack of knowledge into the regulatory framework. I think it does require a different approach and some different thinking.

The Chairman: Thank you. Mr. Trevors.

Prof. Trevors: Thank you, Mr. Chairman. I think we could view this as a transition period from one type of technology to another type of technology, or we could view it as a transition period simply in that biotechnology may give us a larger number of choices in our environmental management systems.

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I would prefer to see biotechnology as giving us more choices in our environmental management. Initially, it may start out that the impact of biotechnology and the percentage it is used in environmental management is relatively small and as we go through this transition period it may increase.

But I do agree with some of the previous comments in that I think the use of biotechnology should be linked to agro-ecology and sustainable agro-ecology. I think that's only wise thinking for future generations of Canadians. I think it's very important that linkage is made. Mr. MacRae has said it in a very specific manner, and I think that should be paid a lot of attention to.

The Chairman: Mr. Samoil touched upon resources and we might want to move into that and conclude in the next half hour with resources and public perception.

In the case of resources, it is necessary for the chair to ask again the participants in the round table whether they could please address the question as to whether there are unique risks to the environment and human health flowing from the use of recombinant DNA technology, ones that have not been experienced with the existing old technologies. If you could address that it would be very helpful.

I wonder who would like to go first.

Dr. Brousseau: I think molecular biology gives us some of the tools to assess some of the problems or risks it may create and also risks occurring in alternate technologies like natural biological insecticides.

Of course, resources are always scarce in research. At least from my viewpoint, I don't see any area where we are fundamentally lacking in at least the existence of tools to look at problems, questions that may be asked regarding the risk assessment of transgenic organisms.

Perhaps the database may be too small to give a fully informed judgment and therefore regulators may say we don't approve this product because of that, but I think by and large the tools are in existence.

Mr. Samoil: I think there's one sector that's missing from the statement you made, and that's the public. Are the resources there for the public to really participate in this meaningful evaluation?

I think the resources aren't there. We're looking at a dynamic system, at something that has a larger timeframe. In trying to stick to the legal end in terms of dealing with compensation for harm, we're talking about a timeframe and resources available to those who have suffered. I don't think they're there. We see lots of situations with respect to pesticides where the resources just aren't available for those to be able to demonstrate and be able to identify that a harm has occurred.

I think that's part of the whole regulatory process and the whole risk assessment process. It is an ongoing process. Because you make a decision to allow release today, there still are effects that are going to be felt later on, or manifested later on, and there's still some regulatory responsibility over that longer timeframe. I don't think we have the resources.

The Chairman: Let's combine a discussion on resources together, as you have already, with public perception. As a member of the public, I must confess to you that when I hear about recombinant DNA I put it together in some rather startling and perhaps primitive terms, because I can imagine, because of my almost total ignorance of the subject, a situation whereby the transfer of genes and all that is implied by this new technology, including genetic engineering, could lead one day to the production of a species of individuals who would be silent, obedient subhumans, if you like, who could be termed slaves of the group that has been able to engineer this kind of DNA feat in a lab run by a couple of individuals who are beyond the control of the rest of society.

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You can see by this example how wild the imagination of an individual can run in this respect, because of my lack of knowledge of what are the real implications of this, or because I have an imagination that is a bit distorted, or for other reasons.

Definitely there has to be some better understanding as to what is the ultimate potential of the DNA application. If we can do that, then we will also be able to draw a line, or to perceive or to define, where the public interest is and what is the role of governments on behalf of society.

So could someone please - perhaps Mr. MacRae, you already indicated that you wish to speak - tackle these two subjects together, namely resources and public perception.

Dr. MacRae: Thank you.

I find it interesting that the general public often asks - and it's usually their first question - the question that the regulatory system doesn't ask. The general public's first question is usually why do we need this? Isn't there another way of doing it that would be less interventionist? Those are questions that the regulatory system doesn't really ask. It's partly because of the design of the regulatory system and it's partly a question of the resources that are available.

In an ideal world, I would imagine we would be transferring both resources and our regulatory structure to one that was truly precautionary, which would say, let's make sure we've exhausted all the ecological options before we allow onto the market something that produces these kinds of fears in the general public. We would actually have specialists who could deal with these precautionary sciences, particularly agro-ecology and health promotion.

It would be their task to first ask those big questions and do an assessment at that level, which is really a broad kind of macro level assessment, before we then put enormous amounts of resources into doing very detailed and very technically difficult evaluations of the safety and efficiency of particular products, especially given that most of the regulators are dealing with information produced by commercial firms.

In that sense, I don't know whether a shift to that kind of system would actually in total require more resources to operate, or in fact it might even be less resource intensive because it would eliminate very early on from the process many of the products that spend years winding through the system currently.

On rBST, again as an example, if the early questions about evaluating rBST dealt with how does this approach stack up with some other ecological approaches - for example, rotational grazing, which has been evaluated quite extensively by scientists against rBGH...? The initial assessment from that evaluation is that rBGH is not particularly helpful given that there are other ways of achieving similar ends and in a much more environmentally effective way and at a lower cost to the farmer. If that was the initial assessment, then we wouldn't have had to spend eight years having rBGH wind its way through Health Canada's bureau of veterinary drugs and the incredible expense that has incurred. If we make that kind of shift to a precautionary regulatory framework and precautionary science, we may not have to devote the same levels of resources. We may also satisfy the public at the same time, because they feel more comfortable with these kinds of solutions, which are not as interventionist and don't appear to have as many risks.

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Ms Mitchler: On the issue of public perception, I agree with you that the public does want to know why we need biotechnology, but I would suggest that the first questions they ask are what is it, why should they care, and why should they be concerned about it.

From what I've been seeing, I think in the media very often they're seeing two extreme points of view: those who are very opposed to it, often on ethical or environmental grounds or whatever, and those who are very, very in favour of biotechnology and want to have a minimum of regulation and checks and balances attached to it.

I think what often is lacking is a middle-ground approach in terms of giving out to the public some very good, user-friendly, understandable information that does not tell them what to think. As a way to do that, I've given those of you who are members of the standing committee a folder that CAC, in conjunction with the FBC, put together on biotechnology. We try very hard to do it in a neutral way and to just present the facts as we understand them to be, of what biotechnology is, what it isn't. We try to demystify it in user-friendly terminology and language by using simple words. We also try to talk about the regulatory framework. We also try to talk about what some of the issues have been, again in very user-friendly terms.

We try to keep the judgments out of it, because my association believes it's not our job to tell people what to think. I think our job is to present the facts as we understand them to be and to let the readers decide for themselves whether this is good or bad or whether it's useful or not.

I believe we have a limited number of extra information kits available at the back, for those who want more.

This is an effort to bring some neutrality to it - and it's not perfect. We did it in a short space of time. It was done quickly because there are products on the market right now, and I really believe there's a lack of simple, understandable, reasonably balanced information.

Now, the problem with developing this was that we didn't feel there was a real benchmark in terms of what neutral information should look like. I only had a picture in my head as to what I thought it should look like. I didn't have a sample I could point to and say it has to look like this. So the difficult line has been to try to put in it useful, simple information. I was trying to keep the conclusions out of it so that the reader can make those for himself or herself.

Thank you.

Mr. Wilson: If there's anything within the farm community that we completely agree on, it's that every sector in the food chain has a responsibility to communicate its particular interest on not just this issue but issues in general that they have influence over. The farm community finds it reprehensible that we now have so many issues on which we are almost literally at the end of the chain - aside from the retailers' niche. The consumer looks to us for information that goes miles behind us into the scientific community or the regulatory community. Yet in my farm market I'm the one who's being asked to show them out in the field what this means so that they can see for themselves. We'll do that, but I'd also argue that no one sector can do any of these issues alone.

As a lay farmer, I cannot communicate the scientific what-have-you on biotechnology. I don't have that understanding scientifically. I also have a vested interest because I make my living doing this as a farmer and as a representative of the farm community. But I think providing factual information is an absolute must by every sector, including you as political regulators, not only on this discussion but also on many of these discussions.

Prof. Trevors: My suspicion is that the public is having difficulty with biotechnology in the environmental field, as well as when biotechnology is applied to human diseases or health.

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One suggestion would be to make the linkage between biotechnology and human environmental health a priority of the government and a priority for public education. The linkage is easy to make. It just needs to be implemented more. I think this is important for the next generation, because if you don't understand the technology, it's very difficult to have an opinion on it and it's very difficult to implement it. I think the linkage can be made easily and it needs to be done.

Mr. Walter: I would like to contradict one of the earlier statements. We've had a lot of surveys in this country on public awareness and public attitudes. Those surveys have come up with a fairly consistent list of primary questions on the part of the public. They tend to be: What is it? Is it safe? Then, in one form or another: What's in it for me...a lower price, better taste, that type of thing? Those are in fact the top-of-the-mind questions for the public.

The second point I wanted to bring up is that an educated consumer is in everyone's best interests. Unfortunately, in Canada we have a geographically diverse and very large audience of some 30 million. It is very difficult, time-consuming, and expensive to get knowledge out to such a large community. The biotechnology community is attempting to do that in various forms. I'll give you some examples so you're familiar with some of them.

For consumers we've developed information kits, like the Consumers' Association and the Food Biotechnology Centre kit you have in front of you. As well, there are a number of web sites, 1-800 numbers, and museum exhibits. Television documentaries have even been developed to try to raise consumers' level of awareness.

We recognized early on that trying to focus on just the consumer was probably not one of the most attractive ways to go because of the costs associated with it, so we've instead begun to focus on the educational system, where we can build on those organizations and individuals who can multiply the messages. We've developed teachers' resource packages and a number of career guides. We've worked on course curricula. We've developed a series of science fair awards, in-class materials, educator workshops, and on and on.

Admittedly, we're doing a poor job. We don't have the resources available to instruct the general public on some of the areas in which they should have a higher level of awareness of science and what the issues and benefits are surrounding this technology. We are beginning that process.

I think it's incumbent on all of us around this table, around the tables that will be before you later on today, and certainly around the government to support those organizations such as the CAC and the Food Biotechnology Centre, which are trying to develop information that is balanced, available, and targeted to the consumer level.

Dr. Keller: I'd like to raise the issue of the questions that a regulator may ask. The point was raised that maybe we should be asking why we need this type of technology. I think our regulatory system needs to be neutral. I don't think we can or should be dictating what we perceive at any time in the history of our society to be good or bad.

That question could have been asked about the development of canola from rapeseed, which was a marine lubricant. It was a crop grown on a few hundred acres in the Second World War to produce some oil to lubricate submarines. Some researchers had a vision that it could be developed into an edible food crop. The question that could have easily been asked was, we never had it before in Canada, so why do we need it?

Furthermore, the meal had toxic properties that caused goitre. Questions were asked about the oil and so forth, but through research and science a product was developed that has now been labelled internationally as a nutritionally superior vegetable oil.

I really would have concerns if you start asking the questions about development. I don't think we can do that. We need a good, effective regulatory system, but we as a society shouldn't be dictating what we think at any time will be good or bad for our descendants. It's too complicated. We need to have a good regulatory system that deals with the issues as they come forward and not try to police them in any particular way.

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The second general question goes back to the chairman's introductory comments about fear. You know, there is a lot of interest in this in the media. Jurassic Park may have exemplified what genetic engineering might do in a science fiction sort of way, but people start connecting these things. Indeed, if we want to extrapolate, it's hard to know what DNA technology will be capable of doing down the road. We need to go forward with a regulatory system now based on what we have. We can't engineer human beings now. That technology is not there, and it won't be there for some time. Perhaps at some time it will. We need to build up our scientific base now.

The point of education has been raised, and not only public education, as two recent speakers mentioned. I think we need to go down to our education system. We teach a lot of history of science in our country, but we need to teach science and it needs to be fully integrated so we don't wrestle with questions of integrating agro-ecology with genetics. Those should be built into our system. I have children in the elementary system, and as a direct observer I see that we're lacking this now. If we want to invest, we need to invest there, because that will build a knowledge base for our future society.

Mrs. Kraft Sloan: In the discussions we had around this issue last spring, labelling was brought up a number of times and the issue was highly controversial. One of the things that was pointed out over and over at our round table today was the ability of producers to have choice and to have options. I'm just wondering how people around the table may feel about the consumers having choice and options by having products of biotechnology labelled so that indeed they can make decisions on whether to purchase that product or not.

Dr. McIntyre: I'd like to respond to some of the comments that Dr. Keller and Rick Walter made and to partially respond to the question Mrs. Kraft Sloan asked. It's in response to an exercise we conducted about six months ago.

I'm with the biotechnology advancement section of Environment Canada, and we're setting up a brand-new program to explore the opportunities for advancing some of the more innovative environmental applications of biotechnology, specifically in pollution control and waste management.

In the process of setting up this particular program and establishing specific program elements, one of the first things I was struck by was a complete absence of assessment of public perceptions, awareness, and concerns associated with strictly environmental applications of biotechnology. I just want to make reference to a study we had done for us; it was a cross-country series of focus group assessments to provide us with a better appreciation of public understanding of the concept of biotechnology of specific environmental applications. I think the environmental concerns strike at the root of a lot of public issues associated with the use of technology.

We also wanted to gauge the perception to current uses of environmental applications of biotechnology and the role of the government agencies in terms of funding, encouraging, regulating, and undertaking biotechnology applications.

Some of the findings of note from this particular study - and I'd like to leave a copy with the committee if I may - are these. Apart from some regional variations and educational differences, this study was conducted in Montreal, Toronto, Saskatoon, and Vancouver. We found for the most part that the environmental and health applications were considered a higher priority than food production. We found that the participants said they would be unlikely to protest the application of environmental biotechnology in their neighbourhoods as long as they are kept informed of the benefits and risk.

We also found that with the briefest of introductions to specific environmental application of biotechnologies, participants were generally supportive, particularly when links were made in known technologies. Interestingly enough, for the eight environmental applications that we presented to the group - considerations of using biotechnology, say, for bio-remediation, where you are cleaning up the contaminant site; or bioleaching, where you are using micro-organisms to leach out the metals from ore bodies; biologically produced fuels; biological pesticide production; and phyto-remediation, the use of vegetative species for cleaning up or rehabilitating or restoring contaminated sites - we received an 80% approval rate across the board. Now, is that conclusive? No. It's a comprehensive yes.

That suggests to us the support for these particular technologies across Canada is 10 miles wide and about an inch deep. Picking up on what Wilf Keller and Rick Walter said earlier, it's incumbent upon us not only to nurture but also to incorporate into the promotion of these particular considerations the continued need for public input.

Thank you.

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The Chairman: Thank you, Mr. McIntyre.

Could we have one or two brief, crisp interventions on the question of labelling as raised by Madame Kraft Sloan before we adjourn?

Mr. Wilson, quickly.

Mr. Wilson: This issue certainly has been on the burner for at least a year and a half now. The dilemma we see is, how do we deal with this in isolation as a biotech labelling issue when you look at the myriad of other things that people would like to see on a label?

We've drawn continually the point that if we have everything on the label, including pesticide use, farming practices, and other philosophical or scientific concerns, physically there's only so much information you can put on it. So we raise that issue.

We also raise the issue of consistency in international treatment. Some of my production theoretically goes to Buffalo, is processed into a food product, and comes back into Canada. If we don't have any criteria as far as imported product and international consistency, then how does that get addressed, especially if that processor is running a biotech corn because it has some B.t. genetic structure back in the original plant material, or some open-pollinated varieties, or some closed-pollinated varieties?

So we see it more as an issue of, if there is value in this, then where are we internationally on developing criteria? How do we start separating some of the good labelling - and this was the issue we raised in the spring - from some of the negative or facetious labelling that now occurs that we fully allow, or I guess in a sense, you fully allow as regulators in Canada, that we've said tends to work in a negative context of providing information to the consumer.

The Chairman: Thank you, Mr. Wilson.

The last word goes to Ms Mitchler.

Ms Mitchler: Thank you, Mr. Chairman. The Consumers' Association of Canada has been supporting the position that the federal government has been taking on labelling. We feel it makes sense to label novel food products derived from genetic engineering on a basis of whether there is a change in the end composition of the product or a health and safety issue such as the presence of an allergen.

Let's say, for example, a peanut gene has been inserted into a food product. Then that product should, of course, be labelled and the peanut gene indicated as being present.

Perhaps if there are religious considerations - for example, someone does not eat pork for religious reasons and a gene from a pig has been inserted into a product - then again there might be reason or grounds to label that product accordingly.

Our concern is that if we label all products that are genetically engineered, for example, a Flavr Savr tomato, it would make sense maybe to have point-of-purchase sticker information above the bin or with the bin where tomatoes are purchased, saying this has been genetically engineered and these are the benefits, and so on.

But how are we going to label in a practical and meaningful way for the consumer the tomato paste that has been mixed in with conventionally grown tomatoes? Are we going to have ``may contain'' declarations on a can of tomato paste? What will that tell me as a consumer? I suggest it doesn't tell me anything.

How do we label, then, commercially prepared pizza that is made from tomato paste made from Flavr Savr tomato, and so on? We could apply the same argument, I would suggest, to canola oil.

I think it makes sense to label where it is practical, feasible and cost-effective to do so. Where it is not practical and it doesn't make sense, then I think we have to rely on a broader program of public awareness, communication, education and awareness, that we start telling people what this technology is and demystify it, answer some of their questions and address what some of their fears and concerns are.

Ultimately I think what the public really wants to know is that this product is safe, that they know what it is, that what the label says it is actually reflects what the product is so that they have faith and confidence in the label, and secondly, if they have any concerns about the way this technology is being managed, that it's being managed in a fair and reasoned and well-thought-out way, that it's not running down the hill amok, that it's being managed fairly and effectively. I suggest to you that those are the things we ought to be most concerned about. Thank you.

The Chairman: Thank you, Ms Mitchler.

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The time has come now for a brief intermission. On behalf of my colleagues, I would like to thank you very much indeed for your participation this morning. Your input has been extremely helpful. I think it was a terrific session. We look forward to another very interesting session at 11 a.m.

In the meantime, again let me thank you very much, each one of you, for your participation, your input, and your advice and wisdom on an issue that is extremely important to us and on which we certainly welcome as much guidance as we can get. This meeting stands adjourned until 11 a.m. sharp.

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The Chairman: We will begin.

[Translation]

During this session, we have the opportunity to hear some of the best informed people on biotechnology and

[English]

on the topic of options and risk communication. But basically it is really to explore together the need for a gene law and a transgenics agency that would regulate transgenic organisms. This is heavy language.

In essence, it brings us back to the hearing in May when Dr. Leiss of Queen's University appeared before us. He proposed to this committee that separate legislation for transgenic entities is needed. He said that for this purpose a special agency, perhaps modelled after the Pest Management Regulatory Agency, should be established.

At that time, Dr. Leiss also went on to suggest that Health Canada and Environment Canada could be responsible for this new agency. The proposal is in good part based on Dr. Leiss's belief that transgenic species are fundamentally different from other products of biotechnology. He told us that the current regulatory framework, which is based on a distributed network of responsibility among several departments, as you know, is not ``inherently credible as a system from a regulatory point of view''. He said that it is perhaps explainable for historical reasons that it is convenient but that it is not credible with the public. Some of us found his comments rather important.

In this session, we will try to explore this idea and seek your comments. We will also try to explore the question about whether it is desirable from the point of view of the public to have regulators who are at the same time promoters, as is the case of Agriculture Canada, Environment Canada and Health Canada, and whether it is desirable, as we now have it, that Industry Canada will be the department coordinating the various other departments.

You can see that we have a pretty massive agenda before us. We will want to resolve it, or at least find some answers, in the next hour and a half.

We may go, if time permits, into the precautionary principle, although it was raised earlier, and the question of public participation, since some witnesses in May suggested that the public should play an important role in the development of regulations and guidelines that are administered by the line departments.

I'm asking you to indicate whether you are ready to jump in, or perhaps you would want to hear a very brief summary from Dr. Leiss, which I've tried not only to condense but to supplement, so as to make the best use of time.

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I'm reminded here that we should introduce ourselves, because we are starting a second session. I will start here with Mr. Radford, in person.

The Clerk: I'm Norm Radford, the clerk of the committee.

Dr. Mark Winfield (Research Director, Canadian Institute for Environmental Law and Policy): I'm Mark Winfield. I'm the director of research for the Canadian Institute for Environmental Law and Policy.

Mr. Knutson: My name is Gar Knutson. I'm the member of Parliament for the riding of Elgin - Norfolk, which is on Lake Erie. I'm a permanent member of the Standing Committee on Environment and Sustainable Development.

Mr. Forseth: My name is Paul Forseth. I'm the member of Parliament for New Westminster - Burnaby, British Columbia. I'm a member of the Standing Committee on Environment and Sustainable Development.

Mr. Ed Norena (Director General, Environmental Technologies, Advancement Division, Department of the Environment): My name is Ed Norena. I'm with Environment Canada. I'm the director general for environmental technology, and I have an additional responsibility of building a renewed CEPA over the next few months.

[Translation]

Mrs. Guay (Laurentides): My name is Monique Guay. I am the member for Laurentides, in Québec, as well as the Opposition critic on environmental matters.

Mr. Asselin (Charlevoix): My name is Gérard Asselin. I am the MP for Charlevoix and a permanent member of the Standing Committee on Environment and Sustainable Development.

Mr. Richard Dagenais (Researcher, Fédération nationale des associations de consommateurs du Québec): My name is Richard Dagenais and I am a researcher with the Quebec consumer association called FNACQ.

[English]

Ms Margaret Gadsby (Director, Scientific and Regulatory Affairs, AgrEvo Canada): I'm Margaret Gadsby, director of scientific and regulatory affairs for AgrEvo Canada. In 1995, AgrEvo's innovative canola was the first crop plant derived through biotechnology to be registered for commercialization in Canada.

Dr. Arthur Olson (Assistant Deputy Minister, Food Production and Inspection Branch, Department of Agriculture and Agri-Food): I'm Art Olson. I'm the assistant deputy minister of the food production and inspection branch with Agriculture and Agri-Food Canada, at present.

My organization is part of the organization that will become the largest portion of the Canadian food inspection agency, which will be created by a bill currently before the House of Commons.

I was also chairman of the interdepartmental committee that dealt with the creation of what is now called the Pest Management Regulatory Agency. I'd be pleased, Mr. Chairman, if you want any background on either of those issues, to go into them in some detail.

Mr. Taylor: I'm Len Taylor, a member of Parliament from Saskatchewan. I'm a New Democrat and associate member of the environment and agriculture committees.

Mrs. Kraft Sloan: My name is Karen Kraft Sloan. I'm a Liberal member of Parliament for York - Simcoe, and I'm the parliamentary secretary to the Minister of the Environment.

Dr. Glennis Lewis (Consultant, Lewis Consulting): My name is Glennis Lewis. I'm with Lewis Consulting in Calgary. My consulting services primarily deal with biotechnology, regulatory law and policy, and risk assessment.

Mrs. Payne: My name is Jean Payne. I'm the member of Parliament for St. John's West, Newfoundland, and vice-chair of this committee.

Mr. Paul Mayers (Head, Office of Food Biotechnology, Health Protection Branch, Department of Health): My name is Paul Mayers. I'm the head of the office of food biotechnologyin the health protection branch of Health Canada.

I'm Conrad Brunk from the University of Waterloo. I do research in the non-scientific aspects of risk management and risk communication.

Professor William Leiss (Professor of Policy Studies and Eco-Research Chair in Environmental Policy, Queen's University): I am William Leiss from Queen's University. I hold the eco-research chair in environmental policy.

Mr. George Michaliszyn (Director and Manager, Chemical and Bio-Industries Branch, Department of Industry): My name is George Michaliszyn. I'm the director of chemicals and bio-industries at Industry Canada. Industry Canada has responsibility both for the industry side and the consumer side.

Mr. Curran: My name is Tom Curran. I'm with the research branch in the Library of Parliament, and I'm a researcher attached to the committee.

The Chairman: I'm Charles Caccia, member of Parliament for Davenport in Toronto.

Thank you. Welcome, of course. We are very glad you were able to come. We certainly like many crisp, short interventions. The chair will also try to facilitate the exchanges as frequently as possible. The first speaker for what I hope is a short intervention is Mr. Olson.

Dr. Olson: Thank you very much, Mr. Chairman.

Your first question dealt with Dr. Leiss's presentation last spring. Since that point in time, the government introduced Bill C-60, which deals with the creation of the Canadian food inspection agency. I believe that bill is currently about to move to referral to committee, and it will be discussed over the next number of weeks.

This agency is the result of a 1995 budget statement by the government that deals with the creation and consolidation of food inspection and quarantine activities by the Government of Canada into one agency. It involves the transfer of inspection staff from Agriculture and Agri-Food Canada, from Health Canada, and from Fisheries and Oceans to the new agency. Part of the transfer also includes staff from Industry Canada who were involved in consumer packaging and labelling as it relates to food. That transfer actually occurred in 1995.

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The decision of the government to proceed looking at that direction was confirmed in the budget speech in 1996. I presume the legislation that's now before the House is a further confirmation in that regard.

The intent of the agency is to deal with all matters relating to food inspection and quarantine. It's not just food, because quarantine encompasses animals and plants, including trees. It deals with seed, feed and fertilizer, and veterinary biologics. It's a fairly broad role in terms of responsibilities.

The agency, if created by law, will report to the minister established by the Governor in Council. At this point in time, the government's statement in the 1996 budget was that the agency would report directly to the Minister of Agriculture and Agri-Food.

The intent basically is to separate the inspection function from the setting of health and safety standards. The health and safety standards would in fact be set by Health Canada and they would be responsible for carrying out an audit of those health and safety standards. The agency would work within a framework - I guess I call it the rules of the road - of health and safety and environmental sustainability, and it would operate to provide services relating to consumer protection and market access.

That's a very short summary, Mr. Chairman. If it would be useful to you, I can provide copies of documents that provide much more information regarding it.

I did mention the Pest Management Regulatory Agency, and if you wish, I could walk through some of the history that resulted in the creation of that group.

The Chairman: It would be helpful if you would indicate, Mr. Olson, whether Bill C-60 will also encompass transgenics or the transgenic agency, as proposed by Dr. Leiss.

Dr. Olson: I think the concept Dr. Leiss was concerned about had to do with the separation of what he termed promotion from the regulatory function. He can correct me if the words are not properly used.

In essence, that's what's happening here. What he defined as promotion is separated from the regulatory function. The regulatory responsibilities for biotech materials will in fact move to this new agency along with the responsibility for the seed, feed, and fertilizer legislation and veterinary biologics. So it will in fact be in a separate agency, accountable directly to the minister.

The Chairman: It's accountable to the same minister?

Dr. Olson: I don't have the exact wording, but at this point in time I believe the way the bill reads is that the minister is designated by the Prime Minister. So there is in fact a separate agency. The intent basically was to resolve the issue of check and balance, in particular between health and safety and the inspection function.

I'm sure most people in the room are aware of the problem in the United States with hamburger disease, which resulted in a number of children dying. Part of the issue stemmed from the lack of check and balance between the setting of inspection standards and the carrying out of inspection functions. Part of the logic behind the creation of the agency is to ensure that the health and safety check is clearly in place and that the inspection function is clearly in place and separate from that.

The Chairman: So you are satisfied that the creation of this agency will separate the two functions that exist at the present time, namely those of protector and promoter?

Dr. Olson: Mr. Chairman, I think it's very difficult in the structure of government, which we're very proud to have, to separate functions into separate stovepipes. You could take the research function, for instance, which in most departments has implications for a whole range of technologies. You mentioned earlier a number of departments that have both regulation and information or promotional kinds of functions dealing with the same issue. In this particular case, we're trying to deal with the inspection function as a separate issue from the responsibilities of the remaining parts of the portfolio that our current minister is responsible for.

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The Chairman: Thank you. Next I have Mr. Leiss, followed by Mr. Winfield.

Prof. Leiss: I have a question for you about something I didn't understand. The health and safety aspects of foods will still be the responsibility of Health Canada.

Dr. Olson: Excuse me, Mr. Chairman. Is it appropriate to interject or...?

The Chairman: Yes, please.

Dr. Olson: Health Canada will be responsible for the setting of the health and safety standards. This actually goes back, Dr. Leiss, to an agreement some three years ago whereby the setting of health and safety standards would be done by one agency and that to further strengthen the position of Health Canada, it would be responsible for the auditing and monitoring of the carrying out of those health and safety standards. The inspection responsibilities, the market access, and those kinds of things with which there is not a health and safety issue will rest with the agency. As of the proclamation of the bill, those all move to the agency from the departments that currently have those responsibilities.

Prof. Leiss: Who will be responsible for giving regulatory approval to novel foods?

Dr. Olson: Health Canada. There's a series of responsibilities, Mr. Chairman, with regard to the components of the seed, feed, fertilizers, and those kinds of things. For example, with feed, you have a product that might be used in a food sense. The key approval, from my point of view, is Health Canada's as it relates to novel foods.

The Chairman: Thank you. Mr. Winfield, followed by Madame Kraft Sloan.

Dr. Winfield: With your permission, Mr. Chairman, I have a couple of questions for Mr. Olson for clarification.

First of all, is this new agency responsible for the regulation of these products? You talked in terms of health and safety. Is it responsible for their regulation from an environmental perspective? Following from that, does the creation of this agency, and particularly Bill C-60, involve amendments to the agricultural legislation - the Seeds Act - under which Agriculture Canada currently proposes to regulate products of biotechnology from an environmental perspective? To be particularly specific, does this agency contemplate regulating and approving these products in the environmental context as being field crops growing in a field and field trials and those kinds of things, or is it looking at them exclusively from the perspective of their being food?

Dr. Olson: Mr. Chairman, first, the existing pieces of legislation - the seed, feed, fertilizer legislation - will come under the purview of the agency. Under those pieces of legislation - and I believe that was reported to your committee this past spring, Mr. Chairman - there already is clear authority to regulate those products. There is also the authority to carry out the necessary environmental assessments. That has been in place for a considerable period of time. The question is whether or not the agency will have the authority to regulate those products and to carry out such environmental assessments as they're required. The answer is yes.

With regard to the actual legislation itself, it is primarily legislation creating the agency and making such consequential amendments as are necessary for the purposes of carrying out actual inspections. One of the issues, Mr. Chairman, that came on the table was that with nine pieces of legislation, there are significant variations over time. In terms of the authorities and responsibilities for the actual carrying out of inspections, there is a series of consequential amendments built into Bill C-60 that in fact allow for a measure of consistency of application of the different pieces of legislation. The other pieces of legislation, Mr. Chairman, are the Health of Animals Act...the Plant Protection Act, the Meat Inspection Act and Agricultural Products Act. All of these affect the regulatory framework for probably 90 plus percent of the food products consumed in Canada.

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The Chairman: Mr. Winfield.

Dr. Winfield: That answered my question a little more, but I also have to challenge Mr. Olson. We don't share the view that the existing agricultural legislation provides adequate authority for the conduct of human health and environment assessments of products. I'm speaking particularly of statutes like the Seeds Act. These statutes make no reference to biotechnology, and they make no reference to evaluations from a human health or environmental perspective.

At best we think it's a stretch. Conducting environmental and human health regulation under these statutes in our view is at best legislative amendment through regulation, and we think this situation is one of the reasons why new legislation in this area is required.

The Chairman: I would rather not at this point have this become a dialogue between two. I will come back to you in due course, Mr. Olson. I would like to invite other panellists or members of the round table to jump in.

Ms Lewis, would you like to intervene?

Dr. Lewis: I have a question for Dr. Winfield. You referred to new legislation. Can you describe a little more clearly what might replace the current regulatory scheme?

Dr. Winfield: The current proposal from the institute is contained in two documents. One is entitled For Who's Future?: A Response to the Proposal of the Government of Canada on the Regulation of Biotechnology under the Canadian Environmental Protection Act. This was developed on behalf of the biotechnology caucus of the Canadian Environmental Network. Essentially, the proposal is to unify regulatory authority from an environmental perspective over biotechnology products that may enter the environment in a single statute, CEPA, for whose administration Health Canada and Environment Canada would be responsible.

There would be a number of additional changes in terms of the criteria employed to evaluate products of biotechnology in relation to the current criteria - in particular, bringing them into line with the requirements of the convention on biological diversity, particularly paragraph 8(g). As well, it would expand the criteria somewhat to allow for more ecological approach, and make provision for public participation and decision-making regarding products of biotechnology.

The Chairman: Ms Lewis, did you complete or did you have a comment to make?

Dr. Lewis: No, that's fine.

Mr. Mayers: Thank you, Mr. Chairman.

In his presentation Dr. Leiss referenced the issue of a transgenic agency, and used the example of the Pest Management Regulatory Agency as a model to consider. I think we have to recognize an important distinction in that the Pest Management Regulatory Agency deals specifically with pest control products, but transgenics are not any single product type. They represent every potential product area, and to apply the Pest Management Regulatory Agency as a model in addressing the safety assessment and regulatory control of products developed from transgenic organisms I think presents a challenge and would dilute the expertise associated with the specific products of the technology as we currently regulate them today.

The Chairman: Dr. Leiss.

Prof. Leiss: That is precisely why I propose to regulate the process and not the product. That is exactly the point. The argument is that - partly it's a matter of how we frame the discussion. As far as I'm concerned the issue is not biotechnology, it is genetic engineering.

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The issue is transspecies genetic modification, i.e., transgenic entity. As a process, that is new. It is not like making beer. If I hear that once more, I may explode a grenade in the room. It's not like making beer. It doesn't matter if it's analogous to it or that things analogously occur in nature.

Say we eventually master fusion technology and someone says we're not worried about that, the sun does that all the time. So what? This is the process and if it results in a duplication of effort, I don't care. It may take 5, 10 or 20 years, but we will in Canada have a gene law. It will come either through rational discussion or as a result of the public being panicked over something that has apparently gone wrong, but it will come. We need to have scrutiny over this as a process.

That can be done in many different ways. You don't have to set up a huge structure. In the U.K. there's an advisory committee on genetic modification. It has unique authority to screen and look at all of the modifications, so that we don't get product-by-product approval, so that you get B.t. put in your potato, your cotton and 35 other things, then they're selecting insects for B.t. resistance. Nobody is looking at the big picture, because you're just approving one product after another. That answers the question - it regulates the process and not the product. Somebody else takes care of the products.

The Chairman: Who is that somebody else?

Prof. Leiss: There is existing regulation to do product-based regulation.

The Chairman: Mr. Mayers.

Mr. Mayers: Thank you, Mr. Chairman. I think it's important to recognize that within the context of the assessment of the existing products, the process is certainly not ignored. In fact -

Prof. Leiss: I agree.

Mr. Mayers: - the process is an important part of that safety assessment because it is impossible to look at a product without knowing how you arrived at the product. So it is considered, but it is considered in the context of the product being assessed. Clearly, there are much larger differences between products being used as human drugs versus foods than there are in terms of the same process applied to arriving at those two products, so the product therefore is the appropriate place to focus the attention of the safety assessment.

Prof. Leiss: I disagree.

Mr. Mayers: The example regarding the United Kingdom is very interesting, because in the U.K. products are assessed on the specific basis of the product. The Advisory Committee on Novel Foods and Processes is the body that assesses the safety of food products and provides product-by-product specific approval for the use of those products as food in the U.K.

The Chairman: Thank you.

Mr. Dagenais, followed by Mr. Forseth.

[Translation]

Mr. Dagenais: I think we all agree with Mr. Leiss' critical view of the current regulatory process. In the paper which was distributed to us, it was indicated that nothing proves there is a conflict between regulating and promoting biotechnologies.

However, the regulation process for pesticides, for instance, is currently being reviewed. In the United States, in the middle of the 1980s, because the FDA and the Agriculture Department were responsible for promoting pesticides, it was felt that this was in conflict with their regulatory function. As a result, some responsibilities were transferred to the Environment Protection Agency. I think the concern was, at that time, that the promoter role was running counter to the regulatory function.

In mon opinion, there are four important criteria that a regulatory agency should be guided by: independence, that is being free from any kind of promotion responsibilities, and so on; scientific and ethical rectitude; accountability, because regulatory agencies have to be accountable to the public in case errors have been made or ill-founded decisions have been taken; and openness, because a regulatory agency should be open to criticism, take the public's concerns into consideration and respond adequately, without withholding anything.

I think that if this four criteria were adopted, it would ensure the credibility of the regulatory process.

Currently, as far as I am concerned, the regulatory process does not meet these criteria, although this is what we used. The model proposed by Mr. Leiss takes most of this criticism into account. We propose that, in Canada, there be a framework law to regulate every aspect of biotechnology applications, from an agricultural, medical and environmental perspective.

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Then, regulation, control and assessment of products will be the responsibility of Health Canada and Environment Canada which will work as fully independent entities within their own area of expertise.

The Chairman: Thank you, Mr. Dagenais.

[English]

Mr. Forseth, please.

Mr. Forseth: Thank you, Mr. Chairman. We are talking at somewhat of an esoteric level about control and how we go about these things. I want to provide a specific example of the dilemma that I come from and the kind of pressures I get from the community and local community groups. I'll use this specific example of herbicide tolerance.

We know that weeds are in competition with crops for space, soil moisture and nutrients, and farmers have used various weed control methods from cultivation, biological control, to use of herbicides. Recently, farmers have had to use mixtures of herbicides to control a particular kind of weed throughout the growing season. But now we have these new substances called broad spectrum herbicides, which allow growers to control a wide range of weeds with a single spray, but the chemicals damage the crop at the same time.

So then we developed plants to tolerate these herbicides - the weeds are killed but the crops are not harmed, so farmers can use smaller amounts of fewer chemicals and spend less time and money spraying their crops. That's the economic imperative driving on one side.

From a community representative standpoint, I want to look at the larger public interest. Certainly I describe that there is the potential for good, but there is also the great danger of mankind making tragic mistakes. So how do we proceed well within the bounds of safety for the common good? How do we control and regulate a very unpredictable enterprise? I think the community is afraid of the unforeseen, unpredicted consequences, especially when we get into the area of manipulation that will make leaps of change that were never possible or foreseen through natural processes.

One concrete example is the Monsanto soya bean, which is resistant to Roundup. Roundup is a mixture that is sold in every garden store and has now almost reached the mass advertising situation. The soya bean is used worldwide. I can envision a situation in Third World countries where this situation could get out of control and Roundup would be used indiscriminately. You can use it increasingly and it may help the soya bean, but what does it do to the overall water table and the environment in a larger sense? We'll begin to find that was not a particularly good road to go down.

Then when we look at the soya bean, what are the consequences for allergies? The consumer, to be able to choose through the lack of labelling.... So we can go in 69 directions because of the economic propellant or the imperative to save money or have a better crop. So from a public perspective we can talk about turf warfare of who's going to control or whatever, but in the final analysis I think we have to be very cautious about where we're going.

I like the idea of these four criteria: independence, the rigor of science, accountability to the public, and openness and transparency. I haven't heard much about those last two today, and I would like some more comment about general accountability to the public through labelling and other public methods of assessment, and a general openness in transparency. Often these things are too technical, and I heard the conversation around here that it's a very technical thing so we will tell the public what's good for them. We need to go that extra step to explain, remain accountable, and remember who in the world we're serving in the first place.

The Chairman: Thank you.

Mr. Mayers.

Mr. Mayers: Thank you, Mr. Chairman.

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The example just raised is very interesting in terms of the discussion of herbicide tolerance. In the case of specific products of recombinant DNA technology that accomplished herbicide tolerance, we can address those, but it's also interesting to recognize that herbicide tolerance can also be accomplished through more traditional methods of genetic modification, that is, traditional breeding methods.

Therefore, in terms of the use of herbicide, the impacts as noted are not any different on those products from what they are for products of recombinant DNA technology. It is the product itself that has the impact, as opposed to the technology by which the product was developed. So the issues around that can in fact be assessed according to the criteria already applied.

You also raise the issue of allergenicity. Well, of course for a product such as soya bean where we know it has the potential to be an allergen for certain population subgroups, that issue becomes a very important part of the safety assessment. So prior to an opinion on a product derived from soya bean, allergenicity would be one of the careful considerations in that safety assessment.

The Chairman: Mr. Olson, please.

Dr. Olson: One of the experiences I've had is that very few people understand the nature of the food production system we have in Canada. Many people have opinions on it and very few of them are close enough to understand how it actually works and the checks and balances that are built in at many different levels to ensure that the product that is provided to us as consumers is wholesome and nutritious and meets the things we require of a foodstuff.

Part of that is the existing structures we have with Health Canada. Part of that is the inspection systems. Part of that is our producers, our processors, and all the other players. I think when you look at a regulatory framework you have to take all those different players and their own personal commitment into account in terms of the product that becomes available to us as consumers. That personal commitment in most cases also includes liability that they produce a product that is in fact safe, efficacious, and all the other good things that go with it.

The other issue is that I don't think many of us recognize that biology is a moving target. Herbicide tolerance and insect resistance to pesticides or whatever product is used against them raises the reality that the biological systems we live within are deliberately designed to evolve against pressures. It's very much a part of the framework that makes up a natural system.

If I could use non-biotech examples as a case in point, when the prairies were opened up in western Canada one of the major problems they had was finding wheat varieties that would grow on the prairies. There was a series of discoveries that resulted in wheat varieties that would grow. Those varieties were successful in western Canada for a number of years until rust varieties - rust is a disease that affects wheat - became prevalent because of the number of acres that were available in western Canada. The source of the rust was probably another part of the world.

The Chairman: You say ``because of the number of acres that became available''. What does that mean?

Dr. Olson: The bottom line is that the wheat varieties were adapted through conventional breeding, through selection of existing material, for resistance to those rust varieties.

The point I'm trying to make is that there's a significant amount of ongoing evolution in terms of existing systems. It is part of the reality. Herbicide resistance and insect resistance are part of that evolution. I think we see that on a regular basis and we have to acknowledge that.

One of the concerns I have also, Mr. Chairman - and I think Dr. Mayers has already made the point well - is that you can't stop a system cold and hope that all change will go away. I think that is part of the issue you're having to deal with here, because there are those who would prefer that to happen.

The Chairman: Thank you.

Mr. Michaliszyn, please.

Mr. Michaliszyn: Perhaps we can go back to basic principles here on the issue of the regulatory framework. Essentially, it's important to understand that we have a system in place that is based on maintaining Canada's high standard for protection of health of workers and the general public and the environment.

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One of the second principles really is that we should be using existing legislation and regulatory institutions in order to avoid duplication and that we continue to develop clear guidelines in evaluating products of biotechnology that are in harmony both with national and international standards.

I think those are some of the core principles. There are a number of others. But essentially what we are trying to do is to balance the economic interests while at the same time ensuring that we do have a regulatory framework that provides for safety on the human side and for the environment.

With that sort of introduction, I want to comment on the gene law and the transgenic agency. From our perspective, while we can appreciate some of the objectives, that type of agency can be accommodated quite well within the existing structures.

I think a transgenic agency, first of all, is looking to regulate the technology side, as has already been pointed out. It is quite different from where the PMRA, the Pest Management Regulatory Agency, stands, which is really a product-oriented regulation. You're really touching on regulating all kinds of products by the way they were produced. This would ultimately lead to a duplication of effort that is counter to the existing regulatory framework.

When I say a duplication of effort, I mean you would have products that would be very similar in their nature but would be regulated by different agencies, so you'd have to duplicate expertise within a separate transgenic agency to look at those products. You might have a novel food product in one group that would be very similar to another product and being regulated in different agencies.

It doesn't seem to make a lot of sense from our perspective to try to duplicate the expertise, but rather to concentrate the expertise and to build on it where it lies within the existing departments and agencies that are regulating those products.

As for ensuring that there are no gaps, CEPA is effectively a safety net. It provides that where those products are not regulated within individual departments we have CEPA, which effectively becomes the overarching regulatory act. So we do have a single act that essentially provides that safety net and an ability to regulate biotechnology products.

From our perspective, I think the single agency is problematic. How can you possibly look at regulating all the products that are already within the jurisdiction of individual departments? It certainly would be duplicative, and I don't think it would increase the benefit to the consumer.

The Chairman: You're making the case that has been brought to the committee's attention by our researcher, Tom Curran.

The case of insulin, I believe, is another one that he brought to our attention in our briefing notes. In the case of insulin, it can be produced in a traditional way, but it could also be produced by transgenic bacteria and thus could lead to duplication of regulatory activities.

Actually, I would welcome Mr. Leiss's comment a little bit later on the point that was just made.

You mentioned the balancing of economic with environmental factors or goals. It seems to me that when you do that, you separate the two, because you can't balance items that are not separate. It seems to me what we're trying to do with all the commitments that we hear, also by virtue of the mandate of your own department to sustainable development, that if anything, we are aiming at integrating economic with environmental goals rather than balancing them out, because once you are trying to balance you are separating the two and you are on a disastrous course -

Mr. Michaliszyn: Well, I agree with you.

The Chairman: - but this is just a comment on the side.

We have Mr. Brunk and Mr. Norena.

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Prof. Brunk: The issue here for me is what kind of regulatory process will instil the greatest level of confidence in the public that their interests are being looked after.

In the research I've done, I've been very interested in looking at cases where you have these wide discrepancies between what the scientists say risks are, or what the nature of the technology is, and the public perception of that same technology and those risks, which can vary dramatically. The scientists, the experts, tend to view that as just an example of irrationality on the side of the public and/or manipulation by media and other things. But often those concerns in the public reflect very important understandings of the nature of the risk and the nature of the technology that tend to be missed in the science.

In the exchange we just had previously here between Mr. Mayers and Mr. Forseth it's dramatically illustrated. What you have are two different ways of looking at technology and looking at the risks that are associated with those technologies. And in this case it's so clear that the microbiologist.... Certain kinds of scientists view biotechnology and genetic engineering as just an extension of old technologies, and that's the message they hope to communicate to the public in the hope that the public will hear the message and then will become content with the technology and with the nature of the risks. There's a lot of evidence that this kind of risk communication doesn't work very well. It hasn't been very successful in the past. It tends to alienate the two communities.

In this case, I think that on the public side not only non-experts but different kinds of scientists, for example ecologists, would take a very different view of the definition of genetic engineering. For them, there is a qualitative leap from the one, traditional technologies, to the new technologies, because they look at it not from the point of view of just whether all these organisms are sharing the same DNA and it's easily transferable, but from the point of view of the impact on the system of crossing species lines in ways that do not happen normally in nature.

I think that if in this situation we do not understand that the shift from the Darwinian world.... Let me put it this way: when we shifted from pre-Darwinian ways of thinking about the world to Darwinian ways of thinking.... All of us in this room are aware of the tremendous social dislocations that took place in religion and in our society, people getting used to the idea that species can evolve and there are not such things as fixed entities in the world.

I think the move from Darwinian ways of thinking to this new understanding that in fact changes can cross over species lines, and where the design is no longer part of the way in which the ecosystem functions in terms of natural selection but it is in terms of human design of the system, which is the major change here, is a philosophical shift and a religious shift in people's thinking that is as significant as the shift from pre-Darwinian to Darwinian thinking. That's what the public is concerned about. It's a whole new way of looking at the world. It has all kinds of implications, which I don't want to go into detail about here.

In terms of a regulatory system that doesn't recognize this, that doesn't instil in people the confidence that all of these new aspects of it - many of them bound up in the comment thatMr. Forseth made - the real concern is what people are concerned about in terms of what values are at risk, and that's what risk assessment and risk management is all about. It is getting a clear view of what is at risk, and what is at risk in terms of public perception is not always the same as what the scientists would tend to identify as the values at risk.

To close off this comment, I believe firmly the evidence shows that public acceptability of risks depends far less on how they are convinced about the magnitude of the risk as it's defined by science, but rather, what is far more important than that is whether or not the risk managers and the risk producers are trustworthy agents who are representing the interests of the people who are at risk.

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Therefore, you want to establish a regulatory agency that instils that trust. Once you lose that trust, as we know full well from mad cow disease, from breast implants, from asbestos and from many other cases, in the regulator or the manager of the risk - it really doesn't matter what the magnitude of the risk is, scientifically speaking - the risk becomes unacceptable and you have a political problem on your hands.

So you want to put in place a regulatory system that instils that trust. In my own view, it's very important that the regulatory system does identify genetic engineering as a different kind of issue raising different kinds of questions, and by flagging it in a separate agency or with separate legislation you speak to that question, which to me is fundamental in the public perception of the risk and is perfectly rational.

The Chairman: Thank you, Mr. Brunk. Mr. Norena.

Mr. Norena: Mine is just a point. I've spoken a number of times to Dr. Leiss about his paper and the creation of a gene law and the transgenic agency. Where I'm coming from is that I believe that in theory this is really a good idea and a good concept, but in practicality biotechnology is now more mature than it ever was. Products are coming onto the marketplace or being developed more rapidly than you could ever expect. It's one of the most rapidly building sectors we've seen. Sectors - there are more sectors involved with biotechnology than you can shake a fist at.

For that reason alone I think we've passed the time when one agency and one law could deal with this effectively. That's why I think what we have right now, the 1993 regulatory framework, is a good start for dealing with it.

Mr. Michaliszyn, with your point about CEPA being a safety net you stole my lines. That's exactly where I wanted to end up, and I believe that this is what is needed in this case. It's an important bottom line for the Government of Canada and for the public of Canada.

I wanted to react to Mr. Forseth's comment about the fact that we need to be more transparent and more open and involve the public in a greater way. We are doing that to some extent, but we can learn, we can do more. We've gone through the Canadian Environmental Protection Act, parliamentary review, and public process on the government response and so forth. We've put out regulations. Both Agriculture Canada and Environment Canada have put out regulations for a public review at this point in time.

At the earlier session we had Terry McIntyre talking about his trying to introduce environmental remediation technology across Canada. He had consultants quizzing people about their views on it. I think we need more of that to be able to deal with Conrad Brunk's view that we need to have trust in the regulatory agencies, so I support your point totally.

The Chairman: Thank you, Mr. Norena.

We have Madame Kraft Sloan, Mr. Knutson, Monsieur Asselin, Monsieur Dagenais, and Madame Gadsby.

Mrs. Kraft Sloan: Thank you, Mr. Chair. I certainly appreciate Dr. Brunk's remarks. I think duplication is certainly in the eye of the beholder and that as we proceed into this area it's important a number of perspectives are represented. We often talk about being in an information age; perhaps there is a lot of information out there, but there are certain knowledge areas that are being lost or not being recognized and not treated equitably and valued the same as others.

In the area of science, we had some very interesting presentations in the earlier round table when we talked about science versus ecology, and there are differences of opinion and approaches in that regard, and then we start factoring in the public concerns.

As a lay person and someone who does not have a scientific, technical knowledge of the field, I think my concerns are still legitimate, and they're based on certain experiences that I have, which I feel are shared amongst a wide group of people. As we start to think about the regulation of the biotech field, I think we have to think of integrating different perspectives, and the whole issue of duplication, as I said, may well be in the eye of the beholder.

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The Chairman: Thank you. Mr. Knutson.

Mr. Knutson: Professor Brunk, I appreciate your comments on confidence. We've had evidence in front of this committee last week from a scientist from Fisheries and Oceans that, from this particular person's point of view, the concern about genetic engineering is not warranted. I asked him whether there is an area in environmental regulation with which he thinks the public should be more concerned than it is, and he mentioned the issue of climate change.

That set off a thought process in my head. I want you just to speculate. This may appear a little off topic, but because of David Suzuki and general information that the public is getting from the media.... They think the government is doing a lousy job in terms of regulating pollutants, that we're marching towards polar ice caps melting, and that we're going to be swallowed up by rising oceans because the government has generally done a poor job in terms of regulating environmental clean-up and fostering environmental clean-up. That lack of trust or the suspicion will translate into this area of regulating new products and genetic engineering, and basically when....

What I'm saying is that if somebody gets up in the morning, reads a headline about climate change, and then goes off the the grocery store...they don't trust government, they don't trust the regulators. We have to take a much more comprehensive look at public confidence in the broadest sense.

Does what I just said make any sense to you?

Prof. Brunk: Yes, it makes sense. I'm not an expert in climate change. I'm not an ecosystem scientist in any sense, but one of the reasons that one is a little easier from a risk management point of view is that the changes are so incremental and so slow that you don't have the ``accident'' that really does focus public consciousness on the risk in the same way. Right?

Mr. Knutson: You have floods and other things that maybe you can relate to climate change and maybe you can't.

Prof. Brunk: You have all the disagreements about whether that flood is the result of climate change or just natural changes in the cycles and so on. It's very easy to hide them.

The cases in which you get outbreaks of disease, the kind of thing Agriculture Canada has to deal with all the time, whereby just one incident can suddenly make the regulator look completely untrustworthy and non-credible, particularly if the regulator has been giving zero risk messages - such as there's no risk and no need to worry - and then you have an accident, are scenarios for dramatic loss of confidence in the regulator. Once that confidence is lost, it's very hard to regain it.

Mr. Knutson: What we're dealing with now, from my understanding of what you've said and others have said, is that there's not a high level of confidence in the regulatory process. Is that right?

Prof. Brunk: I don't want to make that generalization.

Mr. Knutson: Okay.

Prof. Brunk: In certain areas there have been those problems. I've been particularly interested in the nuclear debate, because it has many elements in common with genetic engineering - many of the fears that the two are the same. There, too, the issue and the trustworthiness of the regulatory agency has been very much centre stage.

[Translation]

The Chairman: Mr. Asselin, please.

Mr. Asselin: Earlier, the issue of overlap and duplication of effort was raised. To eliminate that kind of thing, we should also get rid of overlap and duplication of effort between the federal and the provincial governments. The federal, because it plays a leading role, has to consult with the provinces on biotechnology matters more and more frequently.

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People claim that we have to eliminate overlap and duplication, but it is clear that in the biotechnology sector, there is no concerted efforts on the federal government's part. Nobody knows who is going to be in charge of biotechnology. It is going to be Health Canada? Agriculture and Agri-Food Canada? Fisheries and Oceans? Environment Canada?

We run the risk to see this responsibility fall between the cracks. What is likely to happen is that, if everything goes well and if congratulations are in order, someone will likely say, I am responsible, but if there's a problem and if decisions are criticized and condemned, nobody will want to take the blame. Departments are not used as they should be. There is no dialogue between ministers and public officials. We need a bill to get them to talk to each other. More and more, ministers should engage in a dialogue without waiting until they are forced to do so because a bill is proposed. Then again, it's the consumers who pay when there is a health or agricultural problem.

I agree that Environment Canada should play a leading role, but in cooperation with the other departments. If there is trust within the federal public service, there will also be trust on the part of consumers. Personally, I think that in biotechnology matters, Environment Canada, with the cooperation of the other departments, should be in charge. If I am wrong, please tell me.

Mr. Dagenais: First, I would like to comment on the issue of process versus product regulation. In fact, there are lots of areas where the two elements are regulated. For instance, in the milk sector, there are standards regulating the pasteurization temperature, the length of the process and the quality and human safety of the product. If we take the two elements into account, in the end, we can better ensure the public's safety because, if we regulate the product only, it does not mean that each product is tested. We have to ensure that the process fundamentally guarantees that we have a quality product, a better product.

We have to take the two elements into account. Nobody will convince me that biotechnology regulation should only be product-based. We also have to realize that now, with biotechnology, the process can have an impact on the environment, on the health of workers, on the health of people who have to have a medical treatment, etc. So the two elements should be taken into account. We cannot focus on only one aspect. I think that it would be dealing with only half of the problem.

Regarding the issue of risk, it has to be considered in a complex, multidimensional context. Usually, risk is associated with anticipated cost; anticipated damage, the probability that damage will occur. To determine whether the risk is acceptable, I think these two elements have to be taken into account - the probability that the risk will indeed materialize and the cost of the damage. Some applications are unacceptable if they can be deadly, even if the probability of this occurring is very low. In other cases, even if the damage itself is negligible, the probability can be very high. Such an application is, I think, also unacceptable. So, we have to consider both aspects.

It's important that risk assessment and risk management be dealt with separately. Risk assessment should essentially be left to experts, because it involves taking into account scientific factors, even if, as things stand now, no definite conclusion can be drawn when measuring probability or assessing damage. The inaccuracy margin is quite wide. Scientists should be aware of that and tell the truth to the public.

Therefore, risk assessment should be done by a multidisciplinary expert group, and not left to a government official, because of the complexity of the elements that have to be considered.

The other issue is risk management. It should not be up to a government official to decide whether a risk is acceptable or not. This should be done through an open process, by a committee where stakeholders - that is representatives of the public - sit together with scientists, etc., and have an open discussion on the definition of acceptable risk. In the end, risk management calls for a value judgment. Consequently, the choices to be made are socio-political choices. It's important to deal separately with the two elements and to involve the public in decisions regarding risk acceptability.

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For instance, I remember that in the case of breast implants, two years before the product was withdrawn from the market, a doctor working for Health Canada was fired because he said that there were problems associated with these breast implants; however, Health Canada had decided that it was a good product. If within Health Canada itself criticism and differing opinions are rejected, I think we should be aware that, within the private sector, risk management and assessment are problematic issues. If risk is not properly assessed, it will not be managed adequately.

The Chairman: Thank you, Mr. Dagenais.

[English]

Margaret Gadsby.

Ms Gadsby: I'd like to make a series of comments in response to a number of issues that have been raised. I'll try to keep my comments brief so that I can cover the range of topics that have been put forward today.

One thing I'd like to make absolutely clear - and this is certainly from industry's perspective, but I imagine the regulators who sit around this table would also like it made perfectly clear for the transcript - is that we do currently have a registration process. It is functioning. There are no products falling through the gaps, because it is a product-based approach.

I think we've heard a lot of valid concerns for the various environmental issues raised around the table today. Again, each one of those is a very important consideration in the risk assessments, the safety assessments that are going on inside those departments doing the work. So I just want to make sure the record does show that these things are clearly addressed at this point in time.

Based on our corporation's international experience, I'd like to say a couple of things that might help this discussion. Certainly the product-based approach is the approach taken not just by the Government of Canada to this point in time but also by the Government of the United States. It is also the approach taken by the Government of Japan, which has just finalized its regulatory structure for products of biotechnology and has made its first set of clearances.

The place that is notable in not following the product-based design is the European Union. I think my international colleagues would support me in saying that, as sad as it is, their system is not functioning at this time. It's interesting to note that in the wording of the existing legislation, a section has been put in to allow future legislation that is product-based to take priority over the existing process-based legislation. I think there's a message there that the one international group that has tried a process-based approach has not been successful and, as we speak, it is going down the stream to put in a product-based approach that will be accounting for the novel food and novel feed clearances for which we hope there will be legislation in place in the near future in Europe.

Numerous times today, we've also touched on what we might call resistance management issues. As an industry representative, as someone who is very closely associated with the farm community, I would want to make it clear to perhaps some of the urbanites around the table that resistance management is a key problem for agriculture. It is a key issue of focus. This is why individual companies put forward plans to help manage resistance. This is why growers' associations try to put forward plans that deal with integrated pest management. This is why governments work to help us address resistance management issues.

From a purely self-fulfilling kind of use, if you will, from an industry perspective, we see resistance management as a way of guaranteeing the long-term viability and utility of our products. It is in our best interest to propose and promote resistance management so that the good products we have are not denigrated over time, that they are still available to fulfil a unique use as time goes on.

The Chairman: [Technical Difficulty - Editor] ...term for ``resistance management''. What was it called in the past, ``public relations''? What is it?

Ms Gadsby: There are many different ways in which you can manage resistance. One of them would be, for instance, crop rotation, which is a very low-tech way of managing problems that occur in agriculture. It doesn't have to be done on a chemical basis. There are naturally occurring phenomena that will lead to certain products over time to become less and less effective. So there are ways in the agricultural community such that we know to use products in a rotational manner to make sure they are available and useful over a longer duration.

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The other thing I wanted to make clear to the group before I finish here is that the Canadian process, as put forward today, already exercises an abundance of caution. That is why the standards that have been put forward require our industry players in Canada to assemble a package of data that is able to go internationally, which means that this is the highest hurdle.

Whether we like that from a competitive point of view.... I think you already heard Mr. Wilson earlier today talking very forcefully on the issues of competitiveness. But I think the concerns of this committee are clearly whether the standards are high enough and cautious enough. I would submit that they are the highest in the world. I think we should be proud of that, but I think we should work, as Mrs. Kraft Sloan mentioned earlier, not just to focus on effectiveness but also to see, as time goes on, how we can also focus on efficiency.

The Chairman: I invite crisp, short interventions. Mr. Winfield.

Dr. Winfield: I'll try to be crisp and short, but I have a list of four things.

Here are a couple of very quick ones. One is that I have to take issue again with the notion that we have a comprehensive regulatory system. In fact, we don't have one. There are certain aspects of biotechnology that as of today are completely unregulated. Those are particularly the ones that fall under the Canadian Environmental Protection Act, or that would fall under the CEPA regulations. This would be things like bio-remediation, the use of micro-organisms in mining, sewage treatment and a number of other applications. Until the regulations that were gazetted on August 17 come into force, there has been and remains a vacuum.

Second, with respect to the use of existing legislation, I made a point earlier about the adequacy of the agricultural legislation. There are also problems with the existing structure of CEPA. There are a number of technical problems that arise from the fact that the provisions under which biotechnology is regulated were drafted really for dealing with chemical substances, not biotechnology products. That leads to a number of technical problems.

As I pointed out earlier, I have serious doubts as to whether the requirements of the Convention on Biological Diversity can be accommodated within the existing definition of CEPA toxicity. Those things that have to be addressed.

I want to comment very quickly on Paul Forseth's discussion of herbicide tolerance, because I thought it was a wonderful statement of all the issues that the current regulatory system fails to deal with. It looks at these things in isolation. It does not look at these products like herbicide-resistant plants as parts of systems and doesn't assess them as components of systems. It looks at them in isolation. It doesn't put them into any systems or ecological context, and that leads to some very serious problems and inadequacies.

With respect to the credibility of the existing system, there are a number of reasons why it's weak on credibility. We've touched on the issue of conflict of interest. The problem is more acute in some departments than others.

The other problem, though, is that the system presently is entirely and completely closed. There are no opportunities for public input, and there are essentially no mechanisms of public accountability. The only way in which we will know that something has gone wrong with the current system is in extremis, which is if we're counting bodies one day. There is no way to challenge decisions. In fact, it's very difficult to even get at the decisions. That's particularly true with Agriculture's decision-making process.

Finally, I'm going to throw a bit of a curve ball into the discussion of the scope of a gene law. I agree that clearly genetically engineered organisms need to be within the scope of that law as much for the philosophical reasons that Professor Brunk has pointed to and also because it's where things appear to be going with the bio-safety protocol under the Convention on Biological Diversity.

But it is important to recognize that the Canadian system currently does also include certain types of non-engineered organisms. That is in fact a very positive feature of the existing system: there are potential human health and environmental risks associated with non-engineered organisms as well. It's a very useful aspect of what we have that it touches on those things. So we may well be looking at scope in terms of what's genetically engineered, plus certain other categories.

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I'll close it off there.

Dr. Olson: Mr. Norena and Dr. Winfield have mentioned the regulations that are going through the system. It will be interesting to see the comments we get back with regard to those regulations. I believe they've been out for about a month now, and we're expecting closure over the next week or so. Those will come into place early in the new year.

Dr. Brunk raised an interesting point on mad cow disease. For what it's worth as an anecdote, Canada's one case of mad cow disease was actually identified by the farmer. He went to his local veterinarian, who confirmed that this appeared to be the diagnosis and went to the the provincial government. That government took a look at it and came to us. Then we went to the United Kingdom. That chain of checks and balances, that chain of responsibility, worked.

I think, Mr. Chairman, you and your colleagues will recall the amount of noise made when we decided to take all the animals imported from the first United Kingdom find from their owners and have them put down or removed from the country. It raised a pretty significant amount of noise about three or four years ago. A lot of people were pretty unhappy. A lot of challenges to the regulatory authority were done at that point in time.

Since the United Kingdom has gone through, in the last six months or so, the problems they faced, I haven't heard many of those complaints. Points of view do change once reality hits the table.

On the point made by Mr. Asselin regarding overlap and duplication, our consultations with the provinces really go back to the 1980s.

In December 1988 there was a series of workshops with the Canadian Agricultural Research Council. There was a series of meetings held with the provinces on an ongoing basis. All of our regulatory initiatives are in fact provided to the provinces a year ahead of time when possible, unless it's an emergency kind of regulation. So they have an opportunity to comment, input and take part in any kind of discussion.

We've made a very clear policy of ensuring - I think I can speak for my colleagues in the other departments as well - that those regulatory plans are visible and in the hands of the provinces so they have an opportunity to ensure they have the input they want to make.

On the risk issue that was raised by Mr. Dagenais, there is nothing in this world, I am told, that is 100% certain except death and taxes. I'd really like to know what Mr. Dagenais wants in terms of a level of risk, because I don't think zero risk is attainable under any framework in which our world exists. It would be useful if I had a sense of what he could accept as a level of risk.

Finally, on the transparency of decisions, I'd be pleased to debate that at another time and place with Dr. Winfield. That's always an issue regarding consultation and communication. We work very hard at ensuring that information is out, without crossing that line you referred to earlier in terms of promoting a particular function, whether it's the regulation of a foodstuff, how we carry out an inspection function, or in this case the regulation of a particular product that might have been developed from biotechnical processes.

Thank you.

Dr. Lewis: We've heard a lot of comments about public perception. I must say that I think it's very difficult to understand how the public perceives genetic engineering in biotechnology.

That raises another difficult issue, which is whether that's the sole basis for making new law. Do we really need a gene act to address what we perceive to be a public perception? I don't support a gene law. I think that in some ways it narrows the scope of the regulatory process we have now. I have some concerns about doing that.

I've looked at a lot of gene laws throughout the world. I would say there are great difficulties in determining what is a genetically engineered product and what is not a genetically engineered product.

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I think the focus within the Canadian system is entirely appropriate. It is on environmental effects, it's on toxicity. I think that is a real advantage of the system we have now. If there are weaknesses in the system, I think we should address them directly. There are concerns about transparency and public participation; those are the sorts of things we really want to focus on.

I would add something else we need to look at in a review of the regulatory system, and that is enforceability of the laws we have in place.

The Chairman: Thank you. You made a very important point about the legislatures focusing on perception or substance. We could have a very nice round table discussion for three days.

William Leiss.

Prof. Leiss: Thank you, Mr. Chairman.

Remember that I'm always talking not about biotechnology but about genetic engineering; they're not the same. With respect to the issue of public perception, it's not the government that is at risk from misunderstanding the public in this case, it's industry. The genetic engineering industry will have its Three Mile Island, it may even have its Chernobyl - it's inevitable, almost inevitable - and the question is, will the public have at that point a sufficient understanding of the risk to know the difference? There was a difference between Three Mile Island and Chernobyl. With the way we're currently going, no, they won't have it and we'll be in a panic mode.

I do appreciate Mr. Dagenais' reference to the fact that we have had many examples in Canada over the past 75 years in which we have regulated both the process and the product, and sometimes separately, so this is nothing new. He may also be interested to know that as a researcher I had a very nice conversation with some people who worked for Art Olson at Agriculture Canada. I said I was trying to get to the bottom of the product-process distinction, which was the basis of the federal regulatory system, especially when it originated in 1992-93. I said I'd like to see the documentation that existed at the time the choice was made to regulate on the product and not on process. They looked...and I believe they looked, they're good and honest people. There isn't any; there is no documentation at all. It was a choice made solely for bureaucratic convenience and later rationalized. That is a statement of fact. There is no documentation that suggests there was a argument on why it was better to do it one way or the other.

Now, I do want to address only the issue of the charts, that this is a duplication. There is no duplication here. There is not a proposed double review of the same product. This is the way it will work, because we will have this at some point. I'll use the example of insulin, which can be produced one way or the other.

If you, by science and technology, act directly on DNA, you must refer the process to an agency designated for the purpose of screening it. This can be done very early in your product development cycle, so you'll know you'll have the answer and won't need to do it again. If you do that - you must refer - this agency will have a comprehensive knowledge of all such processes approved in Canada. You will miss nothing at all of this. It will have the duty also to communicate with the public comprehensively on the implications of that process and the risks, benefits, and tradeoffs associated with it. It will act as an early screening device for all applications whatever they are - food, pharmaceutical, environmental remediation, whatever - and thus will not duplicate anything.

Thank you.

Mr. Norena: I first want to address Dr. Winfield's point about the toxics and the biotechnology sections in CEPA being together. They are at this time, but in the CEPA as described in the government response, we've chosen to separate the two and to make sure that biotechnology is dealt with in a separate fashion and in a wholesome fashion.

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We've checked with our legal advisers, and they've assured us that the definition of CEPA toxic under section 11 of CEPA will in fact incorporate the concept of biodiversity. We're assured on that point.

Dr. Winfield: I cannot imagine how you can accommodate the words ``conservation'' and in particular ``sustainable use of biodiversity'', which are the words in paragraph 8(g) of the Convention on Biological Diversity, in the current definition of CEPA toxic, especially in the context of the definitions and application of the definition that occurred during the PSL1 process. It would be a very, very long stretch, to put it gently.

The Chairman: Mr. Norena, do you have any comments?

Mr. Norena: I think we've relied heavily on the advice of our lawyers in this area to look at how the implications might affect biodiversity. I think Mr. Winfield has a good point here.

The last point I want to make is with regard to Mr. Asselin's point about overlap and duplication and the federal-provincial issue. The issue of overlap and duplication is not spoken about between the provinces and the federal government. My own sense is I like overlap because it creates good safety nets for environmental protection. I'm concerned when overlap becomes duplication, because it means that we're not managing our destinies and our programs properly.

I have been meeting with some provincial colleagues on the Canadian Environmental Protection Act file for some time now and have briefed them on biotechnology and the regulatory regime that now exists in Canada. They're quite happy to see that it is a federal responsibility. We will leave that with you. They've assured me of it on several occasions.

So it's not a concern of duplication federally and provincially. We need to inform them more as to what other government departments do on this. I've done it from the point of view of briefing my colleagues, and Art Olson has apparently done it with respect to regulations from his point of view. But more information is better than what we have right now. That's the only point I wanted to make.

The Chairman: Thank you. We are now entering the final stretch. We have Mr. Michaliszyn, Mr. Mayers, Mr. Dagenais, and Mr. Olson.

Mr. Michaliszyn: Thank you.

On the point of duplication in response to Bill Leiss, I still believe there would be substantial duplication of effort.

The issue is that from the interpretation that is given, virtually all biological information would have to move to a single agency. However, if you take the example of insulin and look at insulin production as an extraction method versus a genetically produced method, you would still have duplication because you'd retain the extraction method within the existing organizational structure and move the recombinant method to the new agency. You still have to maintain the expertise within both organizations, so there is duplication. Certainly a lot more people would have to be hired to maintain the activities and effectively the same product would be regulated through two different organizations.

On the second point of public input, I think there already is opportunity for public input into regulations through the gazetting process, and earlier in some cases. We shouldn't leave the impression that there is no consultative process available. All this means is that we can always improve this process and we should seek to improve it. Public input is very much desirable to ensure that regulations are developed with a broad understanding of the needs of the public and the industry.

On product versus process regulation, this issue has been brought up many times. I'm always surprised when I hear that we don't regulate the process, we regulate only the product. In fact, we regulate both. You try to produce a new vaccine in Canada by just regulating the final product. You've got to get your facility licensed. Every step of the process is regulated. It is monitored. It is approved. So the myth of not regulating process is just that. It is a myth.

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Prof. Leiss: These are statements by your government officials, for God's sake. I've quoted them.

Mr. Michaliszyn: On a final point, I want to talk about Canada's regulatory system. Canada's regulatory system is actually very well respected internationally and is held as a model for other countries to develop similar systems. It ensures safety, both on the human side and in protection of the environment. It does that in a way that is not a severe barrier to nor impeding economic development.

I think what we have is a good system in place. If we went to a single transgenic agency, we would see a lot more problems in how we define biotechnology and what are the limits to it. We would quickly be wrapped up in some very core definitional problems. Thank you.

The Chairman: Thank you.

Mr. Mayers, Mr. Dagenais, and Mr. Olson, and then we will have a rebuttal for a few minutes from William Leiss and conclude with that.

Mr. Mayers: Thank you, Mr. Chairman.

To follow up on the last few comments in terms of the international aspect, we have certainly been very much involved in broad consultation internationally in the very development of the processes that are currently in place in Canada. In fact, as noted, the Canadian approach has been used by several countries as a model and is in fact a model in terms of the safety assessment of food products for the work that is currently going on in terms of developing international guidance in this area.

In terms of the product versus process issue, before discussions even started in Canada, discussions were happening at the international level. Back in 1990 a joint FAO/WHO expert consultation noted that there were not unique risks associated with the application of recombinant DNA technology to the production of food products.

The very premise on which the regulatory framework in this area has been based is not solely out of discussions within Canada but within the international context. We have been very active in that regard and, as noted, have provided models for other countries to apply. The earlier comment by Margaret Gadsby that our system is one of the very best in the world I think is certainly true and is very much demonstrated by other countries' acceptance of our model in developing their own processes.

[Translation]

The Chairman: Mr. Dagenais, please.

Mr. Dagenais: Regarding risk management, you cannot expect a zero-risk situation. We think that what has to be taken into consideration is both the damage and the probability of that damage occurring, as well as other criteria. For instance, are safer products available on the market? If so, such a fact should be part of the risk-management process and we should not introduce new, higher-risk products, the benefit of which are strictly economic. The choice then should be based on social, rather than purely scientific considerations.

Regarding assessment criteria for new products, it was pointed out that the regulatory agency should only take into account scientific criteria. We must recognize that when the efficiency, the human safety and the purity of product is assessed, there are error margins.

I read recently that, according to some research done in England, there is not statistical proof that recombinant human growth hormone makes people grow taller. We have been using that product for more than ten years, and now, the use of that hormone for humans, particularly children, is questioned. Even the effectiveness of bovine somatotropin is not clearly established. We should therefore recognize that scientific criteria can be questioned sooner or later, as data is gathered and as new research tools become available.

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In the case of ethical criteria, they should be set at the socio-political level before new products and technologies are introduced. Regularly injecting cows with bovine somatotropin, for example, is a new technology, a new process.

Currently, in the producers' instruction manuals, there is nothing about the use of hormones to increase animal productivity. There are directions on the use of drugs for the treatment of diseases, etc. It's a new application and we should deal with this before introducing new products.

There are also the socio-economic considerations. The government should weigh the public's real needs before deciding to encourage a particular technology.

As you know, in Canada, the government put a lot of money in biotechnology and very little in organic farming. A choice was made in favour of a new technology, because it was seen as leading to more opportunities in the long term, as a possible means to increase productivity at the economic level, and as likely to have more impact. However, this was done to the detriment of a segment of the population, even if the need and the demand were there.

So choices were made in terms of research and development resources, and I think such issues should be examined in a broader context and decisions should also be based on values which go beyond purely scientific considerations.

Regarding product assessment in terms of socio-economic value, we should, at least, clearly establish the effectiveness of a product before putting it on the market. It should not be up to the market to determine wether a product is effective or not. We question, among other things, the effectiveness of bovine somatotropin if other factors are taken into consideration, for instance, its impact on animal health, the consumers' response, etc.

A comprehensive assessment of these factors should therefore be undertaken before millions of dollars are invested in a product which might be rejected by the public.

The Chairman: Thank you, Mr. Dagenais.

[English]

The Chairman: Mr. Olson.

Dr. Olson: Thank you, Mr. Chairman. One of the advantages of age is that you have experiences you can call on. I recall the debate on the product versus process question being very key to a national meeting that was held in 1988 with all the regulators in industry and government, and researchers, and consumers. This product versus process issue went through a great deal of discussion.

I think probably what Dr. Leiss is referring to is the documentation that went into a submission to the government of the day in 1992. As you are aware, Mr. Chairman, those documents are privileged information, but the debate had in fact already happened leading up to the current regulatory framework we're operating in.

On BST, I guess - just to remind everybody - the product is not registered for use in Canada. I do appreciate point made by Mr. Dagenais on risk, but there will always be new products and you have to adapt your risk management process to deal with those new products.

On hormones - there are a great many hormones of many different kinds and uses in the world and some of them go back into historic times. I point out that the livestock industry has for many, many centuries used castration of young bulls as a technique to ensure that the steer in fact becomes a larger animal in a shorter period of time. The intent there is to increase or change the hormone picture of that animal in a way that results in a larger animal.

There are a variety of techniques that can be used. Much of the technology that's being contemplated now, or is already in use, will change over the next number of years as some of the advances come upon us.

Thank you, Mr. Chairman.

The Chairman: Thank you. To conclude, Dr. Leiss.

Prof. Leiss: I'm going to say something now that will really floor some members of this audience. I am not a dogmatist on this or any other issue. I think this is a useful discussion. I think it will go on actually for many years, because although Ed Norena said that we have a huge flow of products coming through the system now, it is nothing like what we will have in the future. This is - or may be, if things go well - the technology of the future.

But I think it is actually the industry that is most at risk in this regard, and it should take a hard look at what happened to the nuclear industry, which was contemptuous of the public perception of risk for a long time. Despite the fact that especially in Canada we have a very good technology, in the CANDU technology, you can't sell it anywhere these days, even in your own country. That is the prospect the genetic engineering industry faces, if it does not get a lot smarter about dealing with the public about the nature of the risks associated with it.

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I have a test case for you. I'm going to wait and see whether any agency in Canada who claims to be a regulator of genetic engineering talks to the public about satellite RNA, and if I don't hear it, I will have my answer.

The Chairman: Could you elaborate on this point for those of us who are not well versed in this?

Prof. Leiss: Satellite RNA you would have read about in The Globe and Mail last week in an article by Stephen Strauss based on a new study reported in Science magazine. Researchers were shocked to find that something happened in a genetic modification of viral material that they didn't expect to happen, and that the more lethal mutation comes to completely dominate the viral culture in which it is developed shocked them completely. They didn't expect it.

I want to hear someone discuss the nature and control of that risk with the public. Thank you.

The Chairman: Thank you.

Well, we've had 29 interventions. This was a lively round table. I suppose that for parliamentarians it will be a matter of digesting and absorbing all the points that have been made and perhaps, to borrow from Shakespeare, to decide whether we are to go for process or whether we are to go for a product - to be or not to be; which of the two is the approach appropriate to the public interest? I really don't know. Certainly there are strong arguments on both sides, and we'll have an opportunity in committee one of these days to go into that further.

We have another round table in the afternoon, at 3:30. We welcome those who want to attend in the afternoon as well, but at this point, on behalf of my colleagues Mr. Knutson, Mr. Asselin,Mr. Taylor, Mrs. Kraft Sloan, Mrs. Payne, Mr. Forseth, and myself, many thanks for your participation and for what you passed on to us in terms of information.

This meeting stands adjourned until 3:30 p.m.

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