[Recorded by Electronic Apparatus]
Tuesday, June 11, 1996
[English]
The Chairman: Good morning. The 15 minutes have elapsed, and according to our rule we're required to wait for a member of the opposition before starting. We have a quorum, and we'll proceed with our examination of biotechnology within CEPA.
We're very fortunate this morning to have Professor Leiss from Queen's University with us. He's also the chair of Eco Research and an author, most recently of this book, Risk and Responsibility, prepared by him and Christina Chociolko. I'm told this is prescribed reading for every member of our committee. The content ranges from managing risks to antisapstain chemicals, stakeholder negotiations, Alar, which could be extremely beneficial because we learned quite a lesson with Alar in the 1980s. The concluding chapter is called ``Useful Lessons''. I recommend it to you highly. It's issued by McGill University Press.
It doesn't often happen, Professor Leiss, that authors get a commercial in this committee. We welcome you and invite you to make your presentation so that it leaves enough time for questions. We are expected to adjourn around 10 a.m. to go to the chamber and hear the President of Mexico, for those who want to hear him. We have a good hour and a quarter, at least. Welcome to the committee.
Dr. William Leiss (Chair, Eco Research, Queen's University): Thank you, Mr. Chairman.
I'm here largely because I have a good deal of experience with regulatory systems for a very wide range of processes and substances that involve health and environmental risks. These include pesticides, nuclear waste disposal, prescription drugs, and tobacco.
As biotechnology seems to be, at least within certain bureaucracies, a very controversial matter, I want to indicate to you also the standpoint from which I'm speaking. I'm neither an opponent nor a promoter of biotechnology. My interest is public policy and the best possible and most credible possible regulatory system, because I think everyone benefits from that.
In this context, I believe there is no question that if we in an industrial society have a long-term future, which is somewhat uncertain, biotechnology will provide the fundamental, underlying basis of the industrial economy fifty or a hundred years from now. Just as the great industrial revolution in the 19th century was based on chemical engineering and in the 20th century on nuclear physics, I think the 21st century will be the century of genetic engineering. That makes what we're talking about here today very important, because we are only at the beginning of what will be a very significant industrial enterprise.
I have four points to make here today.
The first is about the existing federal regulatory structure for biotechnology, which as you know is based on a ``distributed network'' of responsibility among a variety of departments. It is my view that this is not an inherently credible system when viewed from the standpoint of good regulatory practice.
Second, I think since it lacks a certain credibility to the public, the people it most threatens are those who are indeed the promoters of biotechnology. I think they should take this seriously.
Third, we have to ask why it was set up this way. There is a rationale, based on the distinction of products and processes. I examined that rationale and found it has no basis in logic.
Fourth, because it doesn't, I think we need something new. I think we need separate legislation for ``transgenic entities''; that is, genetically modified organisms. And I will make the case for that.
My conclusion is that we would all be better off if such a system existed.
In a nutshell, I think the public concern about biotechnology in Canada and about the credibility of the regulatory system does indeed focus in the end on one quite specific issue, but one that is immensely important. That is the creation of transgenic entities, genetically modified organisms, through science and technology, by the transfer of DNA from one species to another or the deletion of DNA from an organism.
That is, I think, the core of the long-term public concern about what biotechnology is and what it might do. If you do not have a system that addresses that core concern, you do not have a good system. We do not have a system that addresses adequately those core concerns.
I start from my first point. What is this existing regulatory system for biotechnology? You have been told in submissions and presentations before this committee about how it works at present, how an application for approval may be relegated to laws administered by one or more of five different departments, although Transport is a minor player - Agriculture, Environment, Fisheries, Health, and Transport - and that two other departments, Industry Canada and Natural Resources Canada, which includes Forestry Canada, have very keen interests in biotechnology, even though they're not principal regulators. So we have a system with a lot of players in it.
I think the first thing wrong is that there are so major federal departments involved, from the standpoint of public credibility this is a confusing and cumbersome piece of machinery. It is a kind of ``Rube Goldberg'' machine of parts assembled from bits and pieces of other tools. I describe it as a regulatory accident waiting to happen.
The type of accident I refer to is something that undermines public confidence in the regulatory system. I believe that's almost inevitable under present circumstances. Now, why?
In the first case, I believe the system we do have is nothing but a bureaucratic convenience. It was designed to be convenient to an existing bureaucracy. It was not designed for any other purpose. Indeed, it followed a U.S. decision of the same type. You have all these players running around and saying, oh well, we already have a bunch of departments that are, as you've been told, based on so-called product lines - food or agriculture, health, fish, and things like that - so why don't we just do it that way?
At the same time, all of them want to be promoters of biotechnology in addition to being regulators. I say none of them seems to have realized how precarious overlapping regulatory and promotional mandates is, for a very simple reason. Credible regulation in every area requires clear and unambiguous separation of a regulatory decision-maker from the economic interests under its jurisdiction. Since they all want to be regulators and promoters, now even Environment Canada, there is not this clear separation between the regulatory and the promotional activities. That is why I describe it as a regulatory accident waiting to happen.
There are many industries and many other sectors that are subject to regulation. I know of no comparable system in regulatory structure in Canada in which regulatory responsibilities are distributed so widely over so many different parties, all of whom are also promoters, and I think it is perilous for this to happen.
There is another point very much simpler. We've had an example in Canada of an area that is also a matter of high public concern; namely, pesticides registration and regulation. For a long time we had a single department, Agriculture Canada, under the Pest Control Products Act. Then, beginning in the 1980s, as a response to public concerns about the credibility of that regulator and the fact it also seemed always to be a promoter as well as a regulator, we created a distributed system of responsibility.
Under memoranda of understanding, some of the responsibility, although it legally rested with Agriculture Canada, was distributed to Health, Environment, and Fisheries. That lasted through the 1980s, but by 1990 it was found wanting. There is a process, begun then, that continues to this day and will result in the final legislative authority for assembling that regulation under a single department, Health, with an agency called the Pest Management Regulatory Agency.
The history of pesticides regulation is a foreshadowing, in my view, of biotechnology regulation. I think if we do it right it will end up in the same place.
Why would we want to be concerned about this? I think it's mainly because a system with so many overlapping mandates and with this confusion between regulatory and promotional activity is not inherently credible to the public. Occasionally the government acknowledges that there's a great deal of public distrust both in biotechnology and in the system of regulation. Then just as quickly, they say they have to educate the public to tell them why the system they have constructed is the best of all possible worlds. But it is not and the public will never believe it, in my view.
The core of this is the rationale that was constructed to justify this system, which is the distinction between products and processes. This is supposedly the reason we have to do things the way we do at present. It is expressed in the very simple statement that the existing regulatory system of biotechnology ``regulates the product and not the process''. You have been told that repeatedly, especially by the federal officials.
My response is that it is hard to know why this is supposed to be a meaningful distinction. In fact, it isn't. It's not meaningful at all. It is in fact a statement masquerading as an argument. Again, you have to look at comparative regulatory structures, with which we have a lot of experience. Think of industries such as chemicals or pulp and paper, which are quite stringently regulated and have been for a long time. Take pulp and paper, for example, which is perhaps the single most significant environmental concern in terms of industrial effluent. Would you conclude that it makes sense to regulate the products of the pulp and paper industry but not its processes? No, it doesn't. We regulate the processes. Very rarely do we regulate the products.
If we come closer to home, Agriculture Canada has been a traditional regulator for a long time. If you look at meat inspection, which is one of the most fundamental and one of the original regulatory enterprises, going back to the beginning of the century and the problems over food safety, meat inspection has always overseen both the process and the products. There's no distinction there.
Look at Health Canada, the primary regulator for food safety. It has always regulated processes for food manufacturing, or looked into those processes as well as the products. In fact, before this committee you had a spokesperson, Dr. Bailey from Health Canada, to explain the system for Health Canada. He said this:
- The review process for biological [genetically engineered] drugs is especially thorough
because it includes a review of the process of manufacture, not just a review of the final product.
I've looked at the rationale as constructed, for example, by Agriculture Canada. There are two contradictory statements in it. I quote from a publication that they themselves issued. The first gives you the line: ``...genetically-engineered organisms are not fundamentally different from traditionally bred organisms''. But they also say in another part of the same publication that the new technology does something ``that is not possible with traditional breeding methods''.
That's a simple contradiction. You can't have it both ways.
You had before this committee a presentation from Dr. Morrissey, in which this was put into a broad perspective. He said that biotechnology was an evolution over 5,000 years of the human manipulation of nature - which is true - starting with plant cultivation and animal husbandry as phase one, going to selective breeding of plants and animals in phase two, going to gene transfer within the same species in step three, and finally going to gene transfer among different species.
It's a four-stage process, but it's presented there as a continuous process without a break. I think this is in fact misleading. I think there is a sharp break. On page 12 of my presentation, I've drawn a line between step three and step four. That's where I think the line ought to be drawn. The line ought to be drawn there for a simple reason.
In the first three stages, which have indeed gone on for the recorded history of human civilization, we have intervened in nature to try to do things to our advantage through cultivation, selective breeding. But what we have done there basically is to accentuate processes already occurring in nature - to speed them up, in effect.
With transgenic entities - intra-species transfer of genetic material - I believe we've reached a new phase. It is not that this is unknown in nature as I understand it, but that it is anomalous, it is not the norm.
So this is my bottom line. I believe it is possible to do a different one that would be more credible to the public, unlike the present regulatory system, and to do it quite simply.
I think it is possible to argue that step four, the creation of transgenic entities through science and engineering, is a sufficiently distinctive process that it could itself be the subject of a regulatory agenda under separate legislation. If we did that, I think this would be a more credible system, because this is the aspect of biotechnology that concerns the ordinary citizen. And therefore, since it is the concern, it will not go away. Indeed, it will be the predominant form of biotechnology application in the future. We have to deal with it. We have to deal with that concern.
I'll be the first to admit that in nature and society there are no really neat packages. There are some loose ends. With transgenic entities, although these are principally human creations...I'm not saying they do not occur in nature. But in fact, if you look at legislation, we are always creating sorts of boxes that are somewhat arbitrary to some extent, because you have to do that in order to pin something down for regulatory purposes.
There are many illustrations of that. Pesticides is a good example. We've had separate legislation for 50 years. It's not necessary. Pesticides are just toxic chemicals. They could be regulated under CEPA or under any other toxic substances management, but we create a special category for specific reasons. It's not necessarily logical, but we have done that.
The Hazardous Products Act also creates a category of processes that are subject to special legislation. As we know, it's quite arbitrary. It's completely illogical that the Hazardous Products Act does not include tobacco, but there are historic reasons for that. It's not logical. It's historical.
In the Income Tax Act, of all places, you'll find a definition of scientific research for the purposes of the R and D tax credit. It's completely arbitrary, but it's there for a pragmatic purpose.
Finally, to come closer to home, there is a definition of the word toxic in CEPA that is at variance from the accepted meaning of that term. It was done for a purpose.
Like all those examples, we could, for a purpose - that purpose being public credibility - design a class of transgenic entities and say these will be subject to unique regulations because these are something qualitatively new in our scientific and engineering innovations, they are things that concern the public, and they should have a solution in law and regulation that is clear and simple, unlike the confusing and cumbersome regulatory structure we now have.
To conclude, this cannot be done overnight. There's too much baggage in this issue already. Too many people have put their careers and their interests on the line with the existing system.
I don't think it can be done by tinkering in the context of the CEPA review. On the other hand, I don't think there's any justification for changing the existing provisions on biotechnology in CEPA. They should be left in place until we get a better system.
That better system is to include a category of transgenic entities either under CEPA or in separate legislation. In my view, it should probably be in separate legislation, because CEPA already carries a lot of baggage, and these arguments about it - which go on largely behind the scenes among government departments - are just tiresome. There's no public benefit in those arguments.
Whichever way we do it, if we can agree that we can create a class for regulation called transgenic entities, we're doing this for public credibility because we want the most highly credible regulation of health and environmental risks.
That means the federal departments that are logically involved are Environment Canada and Health Canada. In my view, I think they would be credible regulators in this situation if they would then also get out of the promotional business and just be regulators. Let somebody else promote the stuff.
I think that Health Canada is widely perceived to be a credible and relatively efficient regulator for health risk matters in most cases. I would submit to you that Environment Canada does not yet have that perceived credibility. That should be addressed, because we cannot regulate transgenic entities credibly without the involvement of the federal environmental department.
The environmental release of genetically modified organisms is the core longstanding concern of the public. It must be dealt with. So the quid pro quo to saying that this should be regulated separately either under CEPA or under separate legislation by Health and Environment is that Environment Canada must get its act together as a regulator and be perceived as an efficient and effective regulator as well as a credible and scientifically competent one. I conclude this can be done but it is not yet done.
Thank you.
The Chairman: Dr. Leiss, this is the first time we can see the end of the tunnel, at least my ability to understand the issue, and it was a lucky day when Ed Norrena recommended that the committee should hear you. This is extremely helpful, I must say, and I'm sure my colleagues want to ask questions.
I will inquire first with Madame Guay whether she wants to go first. Is this okay, Madame Guay?
[Translation]
Mrs. Guay (Laurentides): As the subject is precisely biotechnology, last night I was listening to a general interest program aimed at the general population discussing DNA. DNA specialists were asked whether we would one day be able to detect diseases 30 or 40 years before they develop and whether that presented any danger. The example given was that of immediate breast surgery for a woman who might develop breast cancer 20 years later. Isn't that an enormous risk?
Also discussed was the possibility of couples wanting children who might start shopping around like with a catalogue and decide to have a child with eyes of such a colour and hair of another given colour. Will biotechnology go that far? Is it really desirable or necessary?
Some aspects of biotechnology can raise enthusiasm, but there's another one that is more of a concern and even a bit scary. What do you think?
Our committee has said a lot on the importance of labelling all the products based on biotechnology so that people can know if they're using that kind of product. What's your opinion?
[English]
The Chairman: Thank you, madame. Dr. Leiss.
Dr. Leiss: I had a brief reference in the paper, which I did not read, about the medical intervention based on our capacity to intervene at the level of genetic material.
This is an example of the type of capacity that what is called the new biotechnology will give us, which will raise other problems in society of enormous dimensions, and in this case in terms of medical intervention, fundamental ethical dilemmas. What you refer to, the screening of DNA for genetically transmitted disease or predisposition to a disease, is already possible in some respects. This can have potentially enormous benefit with respect to diseases like cystic fibrosis and so on, but it raises these terrible questions about people shopping for good genes. I'll give you an example.
We know from sociology that in our society taller people have on average higher incomes than shorter people. There is a kind of social interaction process in which perceptions about people related to their height actually have outcomes in terms of people's economic success. Since this is in fact well established, you could have parents shopping around for the type of genes that would give their children a selective advantage in the economic competitiveness by being taller. However, you can see what we call in logic a reductio ad absurdum of that: when everybody does it the whole thing gets ridiculous.
In short, yes, these are very problematic things. We will at some point in the not-too-distant future have a complete description of the human genome. That means we will be able to know where and how to intervene in every single aspect of the make-up of the human entity. With that knowledge comes both the potential for great benefits and the potential for some serious risks and ethical dilemmas.
That is why I am arguing in this paper, although it's not directly on medical interventions, that we need the most credible possible system, because we have these types of new developments that are new and that have many aspects that are frightening and difficult to control.
Now, more briefly on labelling, you've had a lot of discussion on that. I have a view on that since my basic expertise is in communication of risk. For the most part, I think most people are coming to the conclusion that more disclosure is better than less disclosure. In the long run again this benefits the producers as well as the consumers. For single products, like the NewLeaf potato and so on, where it's easy to put a notice on, put the notice on. Since the information is complex, use a 1-800 number so that people who want as much information as possible can get it - and not everybody does.
I've heard only one matter raised that appears to be a practical objection - namely, that when you get down the line in food processing with a lot of ingredients, some of which may or may not have genetically modified components in them, if you actually label everything, you wouldn't have enough room on the label, that kind of thing. So there you have to make a pragmatic decision that you cannot do that.
I'm like those who are in favour of allowing basically what is called negative labelling. That is, you can't label eventually everything that actually may have something in it, but you can permit people who want to develop a line of products to exclude. It's like ``organic''. If you want to label something organic, certainly in California you have to follow very rigid rules about that. It means you haven't used certain things.
We can use the controversy over BST in milk as an example of that. It usually will be at a higher cost, but if producers want to produce a stream of products in which they label them, ``Does not contain milk from cows to which BST has been administered'', let them do it. At the moment it's not permitted and people are against it. This is very foolish, in my view.
In the end I believe most people will not be concerned once the regulator tells them there is no risk, or a very low risk. I believe most people will not be concerned on risk grounds about BST, but if some people are and they want to know, let them know. We can devise solutions to this that satisfy the public. It is not beyond our means.
[Translation]
Mrs. Guay: People just want to know. We've always referred to the example of bovine somatotropin; when consumers buy milk, they want to know if extra hormones have been used or if it's natural milk, so to speak. It's important for people to be able to choose one or the other. When I buy a quart of milk, I do like to know how it was made and whether it contains hormones. You're quite right in saying that you can't write everything down on the label; you are suggesting that we just have ``biotechnology used in this product'' with a phone number that people could use to get more information on the contents of the milk.
[English]
Dr. Leiss: We can't devise the perfect solutions here. All I'm saying is that we can devise good solutions for that. In the end I think it's in everybody's interest - including in the case of BST Monsanto, who makes it - to make the public feel comfortable. It's just common sense, in my view, and we can do that. In the long run, it's not going to be a problem.
I think we want to avoid terms like ``natural'', because in fact we've manipulated nature for a long time and the modern cow is not a natural creation. In fact, this whole natural business can be misleading. The term ``organic'' has those problems too, unless it's self-regulated.
All I'm saying is that we can find solutions in these things that make the public comfortable. I get annoyed when those on the promotional side do things like saying they will not permit negative labelling. It's just annoying, because if that's what will make the consumer comfortable, then do it. In the end it is not going to stop the development of biotechnology.
[Translation]
Mrs. Guay: You were saying earlier that the regulatory system wasn't adequate, that too many departments were involved in the regulations. Is that really delaying the development of biotechnology here, in Canada? What could be done to improve the situation?
[English]
Dr. Leiss: Actually, as someone interested in regulatory processes, I am also interested in efficient regulatory processes. I do not believe it's acceptable to use a regulatory process simply to slow down industrial development. That, in my view, is unacceptable. A regulatory process should have a clear mandate and clear rules and then allow for quick and responsible decisions under those rules, because otherwise you're being very unfair to innovators who are risking a great deal of money in order to do product development, which has potentially great benefits.
I have tried to provide a solution in this, which I haven't described fully, that would meet the needs of efficiency as well. In drawing that line on page 12, I have said that in my view the existing departments can continue under the legislation, such as the Agriculture and Agri-Food Canada Seeds Act and so on, to regulate the products of those first three phases of what is called traditional biotechnology, except that there will be a new phase separated out.
In my view this would be a more efficient system, not a less efficient one, because it identifies that aspect of biotechnology that is of most public concern. It says we are going to do something specific with this and we're going to do it in a way that has only the health and environment departments involved, because the concerns are health and environmental risks. And if you follow my advice, we are going to get them out of the promotional business and have them just regulate. If they do that, I think that can be done very efficiently.
I have been told right now that if you want to cover all your bases for an environmental release involving both the U.S. and Canada, you can get up to 30 separate approvals. That's ridiculous.
[Translation]
Mrs. Guay: Thank you.
The Chairman: Thank you, Madam.
[English]
Mr. Lincoln, followed by Mr. Steckle and the chair, unless other people want to jump in.Mr. Lincoln, please.
Mr. Lincoln (Lachine - Lac-Saint-Louis): Dr. Leiss, I want to pick up on a few of your statements to make sure I understand you completely right.
First, you said that health and environmental risks would be paramount, and that the present regulatory framework is very unwieldy and in fact a mess. You described it as an accident waiting to happen, and unless we were to reform it into a single efficient system, we should leave the present system in place.
I was going to ask you, in that right now we have a conflict of interest between promoter and regulator, if we should include processes as well as products and if the system should be efficient and not slow down any of the machinery.
If I were to describe some criteria flowing from your remarks and the remarks of others to define what criteria should apply to a system that would be efficient, they are that health and environmental risks should be paramount, that they should cover all products and processes of biotechnology, that they should avoid any conflict of interest between promoter and regulator, that they should provide for pre-manufacturing and import modification, that they should involve a proper and efficient assessment and evaluation of the products, and that there should be some sort of system of notification of the public and input by the public.
Dr. Leiss: Yes.
Mr. Lincoln: Would you say these would be fair criteria in any system of regulation?
Dr. Leiss: There's one important proviso. In accepting my argument that the distinction between products and processes didn't make sense, you said regulate the products of all processes.
I've tried to avoid making a more cumbersome system on that point. The diagram on page 12 separates out a unique process. In the new biotechnology, as opposed to the traditional biotechnology, that unique processes is defined elsewhere in the paper as:
- the creation of transgenic entities through science and engineering that involves the transfer of
DNA from one species to another or the deletion of DNA from an organism.
That's also the process that's of concern to the public. That's the process that should be separated out and subject to unique legal and regulatory control.
The processes that fall out under categories one, two and three, which are described - I accept that as traditional biotechnology - are in my view adequately now regulated under existing acts, like the Seeds Act, Fertilizers Act, Food and Drugs Act, and so on. That can all be left in place.
You break out this process, but the current system does not do that. It pretends that it's no different from anything else, but it is different.
Mr. Lincoln: Would it be possible in terms of legalities and everything to describe that category, phase four, transgenics or intra-species transfer processes, and products from the others, so clearly as to leave no doubt or conflict?
Dr. Leiss: I believe so. I have tried to check it out in terms of its scientific basis. I've said in the paper that I think this is at least plausible. Say someone comes back and says I have it all wrong and I'm a scientific ignoramus. Well, let me hear the argument. If I'm persuaded, then fine, I will abandoned this.
But I have not heard that. In fact, I will be quite surprised, but I'm willing to listen to that. So my contention is that this is a plausible argument. Until it is refuted, it should be taken seriously, and it has never been taken seriously.
Mr. Lincoln: I'll just end my questions. So you seem to share the view of the biotechnology institute or association that came before us and was asked the same question. I think that was the group.
If we can't change the system adequately as described by you today, then we should leave the present one alone until we reach the point at which we can properly deal with it.
Dr. Leiss: I'm referring to suggestions and concerns that the system we now have will be modified again under this notion that products that are or may be regulated under existing legislation.... This is the argument that has been made before you in other submissions. I think it should just be left alone. If we can't deal with the big question, which is here right now, leave it alone and set up a process that enables us to examine whether we should have a different one.
Mr. Lincoln: Thank you.
The Chairman: Thank you, that's very helpful.
Mr. Steckle, followed by Madame Payne and Madame Kraft Sloan.
Mr. Steckle (Huron - Bruce): Thank you, Mr. Chairman.
Professor Leiss, I found it very interesting this morning. Certainly on the second page you allude to the fact that you have worked in the area of general risk management, particularly as it relates to high-level nuclear waste disposal. I would like you to explain to this group the difference between the high level and the low level, if there is such a creature. Perhaps you might also want to comment in terms of Canada's interest in pursuing fuel-grade plutonium in terms of the MOX project.
I have a particular interest in that because that particular institution is within the boundaries of my riding. So I have a personal interest in it, but I'm wondering how you feel about the current level of safety in terms of how we've been able to store the waste from these sites. Are you satisfied that it is currently being done properly, or have we gone wrong some place?
Dr. Leiss: Okay, I can do that briefly. The reference to low-level waste is the Port Hope wastes. There's a separate controversy about whether to move them somewhere. These are the wastes that result from the processing of uranium. They're now in various landfill sites around Port Hope.
High-level wastes, of course, are the ones now in swimming pools at the reactors. We have a major set of hearings going on in Canada right now about the concept of the deep disposal of that in the Canadian shield. So that's the distinction.
I made a presentation before the hearing board, the panel that's examining the deep-disposal concept. My own view was that since they had never adequately dealt with the concept of acceptable risk.... In most controversies, we have to make a decision quickly; in this case, we have the luxury of time. The stuff is quite adequately dealt with where it is now in water storage. We can take another ten or twenty years to figure out the best solution.
In fact, I think putting it way down in a deep hole is not a good idea, but that's a separate argument. We don't have to decide right away. We have lots of time for that. I believe we have an adequate existing system of protecting the public from the risk of high-level nuclear waste. We can't do that indefinitely, but we have enough time to design another one that's both cost-effective and acceptable from the risk standpoint.
About processing plutonium, which is one of the most hazardous materials we will ever encounter, the main risks associated with that are in dragging it around from place to place. There's a great public benefit in recycling the materials from nuclear warheads to make them safer. Whether that should be done by bringing the stuff here and used in our reactors is a very difficult issue requiring very close examination primarily because of the risks of just moving the stuff around.
Mr. Steckle: Might I ask you to explain then how the risk is so much greater in moving this low-grade plutonium around when in fact it has been moved around in the -
Dr. Leiss: Oh, it's not.
Mr. Steckle: It's no greater?
Dr. Leiss: No. My own view is that the Port Hope waste should be left where it is.
Mr. Steckle: No, but I'm suggesting that with the plutonium, in moving it from the U.S. in another form to Canada, in what sense is that more dangerous? They've been moving these warheads around from one end of the country to the other without incident.
Dr. Leiss: Not in Canada.
Mr. Steckle: No, but is it more dangerous in Canada than in the U.S.? I'm being the devil's advocate for the moment, and I'm asking you to expound on that.
Dr. Leiss: I'm not saying that it is. I think that is a major concern, and it should be addressed.
Mr. Steckle: Okay, I won't pursue that one for the moment. I'll ask you to explain something on page 5. I think my colleague has already maybe touched on that. Could you give us an example of where we've had a regulatory accident? You can perhaps elaborate on that.
Dr. Leiss: In a footnote I say that the type of accident I'm referring to is something that undermines public confidence in the regulatory system.
In February, there was coverage in The Globe and Mail and in other places about the NewLeaf potato. It was certainly claimed that some of the potatoes from experimental plots were in the marketplace before the final approvals had been given. There was an explanatory letter from one of the officials at Agriculture Canada a couple of days later. I didn't find that very convincing.
This is an example of something that I think is precarious. A perception of a little bit of fiddling with the system, because the concerns are so high, can send things off the rail. Whether this was the case or not here, I'm not really certain, but that's what I mean. There's some perception that something has been evaded or has slipped through the cracks, because the system is all over the place and so many people are involved. It's that type of thing.
Mr. Steckle: I have one final question. How can we separate completely those who have a vested interest in a new technology and those who regulate the system? We've always had, and there will always be in my opinion, the efforts of those who want to pursue a certain science or technology. We're certainly looking at the whole issue of biotechnology, so we're going to see this. How do we separate this completely, or can we ever hope to separate completely those who have the interest in biotechnology and those who regulate it?
Dr. Leiss: I don't think it's very difficult in this case if you accept the argument that the new thing we should do is to create a separate legislative authority for transgenic entities. The right departments to do that federally are Health and Environment. They're not promoters; they're just regulators. So the agriculture and forestry departments and the others can do that if they want, although I still think that promotion should be done by industry. I'm not sure really why government is in this business anyway. But in the case of Health and Environment, if they are the regulators, then they are not promoters. Simple.
Mr. Steckle: But given that politicians help create regulations and the vested-interest groups make presentations to politicians -
Dr. Leiss: We now have a credible system, in my view, of regulations for pesticides, finally. In Health Canada, in the Pest Management Regulatory Agency, they are, unlike some of the people who were involved when it was Agriculture Canada and who were ultra-promoters, they're not promoters. I think we have a very credible system now for that. It's going to work really well to solve the problem.
The Chairman: That should be music to the ears of Mr. Lincoln, who was the engineer behind that change. You made a friend in the committee today, yes?
We have now Mrs. Kraft Sloan, followed by Mrs. Payne and the chair.
Mrs. Kraft Sloan (York - Simcoe): Thank you, Mr. Chairman.
Dr. Leiss, I was wondering if you could identify some ways in which Environment Canada could improve its reputation as a regulator.
Dr. Leiss: I'm sure it largely comes from experience. They haven't done a lot of it.
It also comes from perception. I've been in this a long time. There is and was a perception, especially in the 1980s, that Environment Canada became - like the way that Agriculture Canada had been - long-tied to its own users, such as farmers and so on. Environment Canada became tied up with the interests of environmental organizations. They were not sufficiently distanced from them. In fact, they were funding a lot of them.
I'm dealing with perceptions here. But in the risk business, perception is reality, as we say. So there is, certainly in some quarters, a perception that as a federal department it shared the standpoint of environmental organizations. Thus, they were sort of involved in the interest group side of things as opposed to standing apart from that. I think there is a bit of truth to that.
People have pretty much got out of that because there's less money now to be distributed. So it has probably solved itself in a way. But I think, again, that a credible regulator has to stand apart from all constituencies that are interested parties. In fact, I believe the democratic system is much stronger when we have a pluralist system of interest groups that fight it out among each other.
I think we get good results that way, so I'm in favour of that. But the regulatory department should stand aside from that and have a clear set of rules based upon their assessment of the balance of risk-benefit trade-offs. There should be an acceptable risk, and those rules should be administered fairly and efficiently.
We still have a lot of, in my view, too much behind-the-scenes toing and froing in the regulatory system for toxic chemicals and so on. We don't yet have a clearly constructed....
Compare it to Health Canada, which has been in the business a lot longer. That's because food safety, beginning in the early 20th century, has been one of the key concerns under the Food and Drugs Act. Basically, I accept the kind of nice, little self-promotional thing you get from Health Canada about the safety of Canada's food. It is a good regulator. Food safety is a difficult issue. By and large, they're not perfect by any means; they make mistakes like the rest of us do. But they are a credible regulator, as they have a long experience in the business.
Environment Canada can be so, too, if it wants to be. But it has to first decide if it wants to be so. I'm not sure. I'd like to think that they have decided they want to be. I'd like them to make that decision, and then they can do it.
Mrs. Kraft Sloan: You were talking about setting out a separate regulatory authority for transgenic entities. I'm just wondering what some of the practical implications of that might be. Are we looking at different kinds of assessors?
Dr. Leiss: No. The risk assessments will be no different. I've argued that the existing system is based on the contention that these entities are just like everything else that we've done for 5,000 years. I've said that's not plausible and that you should separate them out.
It simply means to identify them as things that are distinctive, and thus subject to a specific process. It means simply taking that class of things in the future, which will be the largest class of things we do in biotechnology by far - the future - and the most problematic and the one that gives us most concern.... It means taking it out and saying that whereas in all the other things that come under points one, two, three, traditional biotechnology, yes, you can keep the existing system.... If it's a seed, you can regulate under the Seeds Act; if it's a fertilizer, under the Fertilizers Act; if it's a drug, under the Food and Drugs Act. You would leave it all in place. Nothing changes.
But in this, you have a structure that clearly says that health and environment are the concerns and nobody else is in that game, period. That's all it says. It says nobody else is in that game, just those two regulatory departments, and they simply fine-tune the assessment process they now have. So it does not change the assessment process. I believe it will be actually more efficient, not less.
Mrs. Kraft Sloan: We've heard the argument before the committee many times that biotech is really the only way we're going to be able to feed the world's growing population, and that the transgenic material being created will be akin to or greater than the green revolution. Given the vast explosion of population we're witnessing, if we don't do this, people are going to be starving all over the world. I'm wondering how you would comment on that.
Dr. Leiss: Remember, I said neither a proponent nor a promoter. This is highly amusing. You know the fate of the green revolution. This is an example of what you call chasing your tail. If you think this is a solution to the problem of world hunger, you're dreaming. If it produces more nutrition, we'll get more people. You chase your tail. There are hopefully other solutions involving social structures and changes, but no technology can solve social problems.
Mrs. Kraft Sloan: Other witnesses have brought forward the argument that if you have a tree that grows five or ten times faster than another tree, then it's going to suck up ten times more nutrients in the system. Therefore you have to have a greater reliance on artificial nutrients and chemicals and things like that to support it, which has a different order of environmental effects.
Dr. Leiss: I'm getting outside my expertise. All I would say is that one of the main problems we have with the social control of technology is that people like to give you a nicely packaged solution and say, look at the great benefits we have here, and later we find out the other consequences down the chain of an ecosystem and so on.
Obviously for any evaluation one has to look at the whole package and the whole chain of consequences, and as long as we've done that, then it's okay. I don't think in principle there's a problem there, but the serious point is to make sure the evaluation covers all of the consequences down the chain and doesn't arbitrarily cut it off at one point and say, this is a great package, and then we find out that the negative sides have been separated from the positive.
Mrs. Kraft Sloan: Are you aware of a capacity in Canada to undertake this kind of evaluation?
Dr. Leiss: Oh, yes, we have that capacity.
Mrs. Kraft Sloan: We have had some witnesses before the committee suggesting that an examination of the impact on ecosystems and this sort of thing within the field of biotechnology is fairly limited.
Dr. Leiss: Scientists will always tell you that you need more science and more funds. I believe we have a very high capacity, including ecosystem science in Canada. I wouldn't be concerned with that.
The Chairman: Let me ask a couple of questions to complete the first round.
You told us, Dr. Leiss, that if we can't set up an alternative, well-organized, orderly system as you suggest in your paper, then we should stick with the one we have. Would you comment on the government response to the CEPA report as an alternative to what we have?
Dr. Leiss: I have read all that stuff, and I've read some of the commentary on it. I found it actually a little hard to follow, as to what exactly of any significance was being proposed, as opposed to the existing system.
I know the comments that have been made would suggest that there is a weakening of the current system because of the provision or language that says that CEPA should not apply to the classes of products that are or may be regulated under existing legislation. I didn't find the government response very clear on that, if in fact that's what it was tending to do - to make that type of change. I'm not in favour of that because I think that's tinkering with the existing system and what we need is a much better look at the whole thing.
I didn't find that response entirely clear on what exactly was going to be changed. Maybe you can tell me, since you are much closer to it than I am.
The Chairman: We spent a lot of time discussing the role of the safety net - whether it was one that is desirable or not. Would you comment on that?
Dr. Leiss: As part of the existing rationale, when you have this distributed system, you must have a safety net, because otherwise you can have clear problems. So I don't find anybody questioning the need for a safety net.
I think there was a suggestion that fewer things might fall into it because they would be captured elsewhere. But again, this is part of what I regard as the intolerable vagueness and potential confusion of the existing system. For me it's really hard to pin down what the real consequences would be.
The Chairman: Finally, at the bottom of page 13 you have a paragraph devoted to how this law would work. Could you please elaborate on that paragraph and expand on the alternative law that you are proposing?
Dr. Leiss: The argument here is that, based on my limited knowledge of this aspect of biotechnology in terms of that four-step sequence, it is possible clearly and unambiguously to define an object of a regulatory system - that is, a class of things to which it will apply. This definition is given in quotation marks near the end of page 13: ``the creation of transgenic entities through science and engineering'', etc. That is a clear and unambiguous reference; thus we can identify specifically what processes we're talking about. So if that is the case -
The Chairman: Within that context, right?
Dr. Leiss: Yes. And my argument is, because the whole argument is based on credibility, that this is exactly the aspect of biotechnology that is the subject of public concern - and legitimately so, in my view.
Moreover, it is the aspect of modern biotechnology that is the future, and is precisely where the most powerful innovations will be made. We will continue to do the other things called traditional biotechnology. All of them we will continue to do, and that's fine; I believe that's not problematic.
This is regarded as problematic. This should be broken out. The argument is not credibility. It is that you can then tell the public, we have heard you; we have listened and heard you, that this is what concerns you, and therefore we are going to set up a system to ensure the proper assessment of risk there, which is transparent, simple, easy to understand and easy to administer, and there will be no ambiguity as to who is responsible for what. In the current system, in my view, there is a lot of ambiguity.
The Chairman: Give us some examples, please, as to how you would see the procedures. You say: ``...all products of traditional biotechnology would continue to fall under the jurisdiction of existing product-specific legislation.''
Dr. Leiss: Yes. For example, we still have selective breeding going on all the time, and on number three, the intra-species gene transfer, we have other types of activities in which we're trying to improve varieties - seeds, various crops and so on, by fooling around with the complex of traits within that, whether it's wheat, oats, or whatever. We have done that for a long time and we continue to do that. That goes on, and the products of that are adequately regulated and so on.
Take this other classification, transgenic entities. You've heard of transgenic fish. You've heard of the fact that they've taken a gene from a cod and put it into some other kind of fish. At the moment I'm not sure where that falls, maybe Fisheries; I'm not even clear in my own mind. In any case, that's a transgenic entity. That, in my view, would come under the new system of regulation, whereas if we're doing something under one, two, and three, it will continue to be in the existing system.
The Chairman: There would be a transgenic entities act, so to speak, and under that act you would bring in this new fish, and you would do what at that point? Which becomes then the responsible operative department?
Dr. Leiss: You set that up.
My view is that, like CEPA, it would be a joint venture of Health and Environment, because health risk and environmental risk are the two aspects of the concern. It would say that for all transgenic entities that is the route. It's not some other system where first we decide what type of product it is - is it a fish, is it a plant, is it a drug? - and then we decide, oh well, if it's that one it goes this way, if it's the other one it goes this way. No. We would have it very clear: if it's one of these, it always goes that way, and it only goes that way.
The Chairman: At the present time you would recommend that this become a responsibility of the health department rather than the environment department?
Dr. Leiss: No, both jointly, as CEPA has, both jointly.
As I said in the last part of the paper, the environmental release of transgenic entities - in addition to their human health consequences - is one of the fundamental concerns. It has to be addressed, and if it is not to be the federal environmental department to address that, then what are we doing with a federal environmental department?
The Chairman: And promotion would no longer be the business of government?
Dr. Leiss: Certainly not those departments. My own preference is that governments generally get out of the promotion business and let industry promote the stuff, but if the other departments who would be excluded from the transgenic entities want to continue that stuff, fine, let them do it.
The Chairman: Second round. Mr. Clifford Lincoln.
Mr. Lincoln: Mr. Leiss, I just wanted to get your thoughts on this sort of line between promotion and regulation.
I recently asked a representative, I think it was Dr. Morrissey from the Department of Agriculture, about the news release of Agriculture and Agri-Food Canada on November 14, 1995, which really had struck me as going far too far, just passing on the overseeing and the monitoring of the regulatory framework to industry. It's headed ``Privatization of Dairy Genetics'' and it says,
- ...the federal government has committed $12.4 million in the next three years to the Canadian
Dairy Network (CDN) for dairy cattle milk recording and genetic evaluation.
- - that's what it says -
- The CDN has been formed by national and provincial dairy industry and herd improvement
associations to take over the functions formerly operated by Agriculture and Agri-Food
Canada (AAFC). The CDN will assume responsibility for all activities connected with dairy
milk recording and genetic improvement.
- ``It is the right time to transfer these programs to the private sector since the dairy industry is
well organized to accept and deliver these programs in a streamlined fashion'', said Minister
Goodale.
- It goes on to say that:
- The transfer of the dairy-related programs ends AAFC's on-going involvement in genetic
improvement and evaluation programs for Canadian livestock. Similar programs for beef,
swine, sheep and dairy goats were successfully transferred in March 1995 when it was decided
the livestock industry would be better served if the programs were operated by industry.
Dr. Morrissey told me that this was very innocuous because it really related to things like weights of the.... Does it not lead to a logical progression, where one minute you say that they're doing very well in monitoring weights and stuff, and the next minute you ask why shouldn't they do something else and look after the gene transfer itself, because they're very well equipped now? We've got out of this field and we don't have any experts. They do. Isn't that another conflict of interest situation?
Dr. Leiss: Actually, I don't use that term. Other people use the term ``conflict of interest''. I talk about ``overlapping mandates''.
I think what you're referring to in this specific case is just an instance of a lack of trust. I think it is well founded because of this overlapping of promotion and regulation. We don't really know what hat they're wearing at any one time, right? That's part of the problem. And so it leads to a suspicion.
We also know there's a kind of general deregulatory disease out there that basically floats up from south of the border and has infected some Canadians - fortunately not too many, so we're fairly immune to it. The problem is the kind of suspicion that's engendered by this confusion of promotion and regulation. So we never know what hat they're wearing, and whether or not they're making the judgments, because they're all behind closed doors.
I'll be very frank about this. Those of us who are Ottawa junkies know there have been furious backstage bureaucratic battles over things such as responsibility for biotechnology in the context of the CEPA review. Most of it's closed off from public view because it's advice to ministers and therefore confidential.
Part of the problem with the overlapping mandates - and one of the reasons you might well say to get all the departments out of this promotional business - is that we know that if you don't, even if we have a good regulatory system behind the scene, the other departments are always going to be putting their two cents in there and trying to serve their client interests by operating on the system.
If the target is credibility - and I believe it is in the industry's interest to have a credible regulatory system - then make this clear: either you're a regulator or a promoter, not both. Otherwise we'd never know which hat you're wearing when you're doing some particular thing. This could very well be completely innocuous. You have these well-founded suspicions because of this problem of never knowing what agenda is being served.
The Chairman: Thank you. Madame Kraft Sloan, please. No, sorry, Mr. Knutson is first.
Mr. Knutson (Elgin - Norfolk): Thanks very much, Mr. Chairman. I apologize for coming late.
Professor Leiss, if not the crux, at least one of the core elements of your thesis is the distinction between transgenic processes or products and the more traditional ones. You're saying it's fundamentally different.
I'm just wondering if you can expand on whether it is fundamentally different, because there is an additional inherent risk either because of the newness or because there's a general suspicion in the public. Are those the core reasons why it's in our interest to set out a separate act? Do I have that straight?
Dr. Leiss: Yes. It is my belief that it is fundamentally different. In fact, I believe the Agriculture Canada document I quoted says this.
The phrase they use says these are things that cannot be done. That is not possible with traditional breeding methods...fundamentally different.
Mr. Knutson: What do you say to the person who says, so what? Somehow do we tie it back to risk management or public acceptability, which seem to be two of the types of things?
Dr. Leiss: Yes, certainly the presumption is that although it is correctly described as something that can happen naturally - that is, I'm told, in virus host interactions - it is not the norm. The free exchange of DNA among different species is not the norm. It is the exception. Therefore, we are now playing in something that is exceptional, and since we are doing that, we have to be extra careful. So it's a higher level. Let me give you one example.
My most extensive actual experience in this is working with Forestry Canada on a project that is not yet completed, which ultimately, I hope, will result in adequate public communication on a genetically modified organism that they have in fact developed. It's for the control of spruce budworm. It's called a baculovirus, a genetically modified version of Bt.
Genetic modification is done for a specific reason. You're concerned about increasing pest resistance to Bt, yet you don't want to use the old traditional chemicals. This is a very good and positive thing, and those involved in forest pest management should be concerned with this. It's a very complicated science.
I found out one of the things you could do to increase the potency of that engineered virus is to incorporate a scorpion gene into it.
Mr. Knutson: Scorpion?
Dr. Leiss: Scorpion gene, yes. I had some long sessions with the biologist who actually developed this out of FPMI in Sault Ste. Marie.
Since I don't have a scientific background, I'm a surrogate for the public. I have to understand it first if I'm to help explain it to the public.
I know they are convinced they can do this in a way in which there's a very low probability that something they don't want to happen will happen. In other words, they want this to go out, because this virus is very specific to the class of insects they're working on. Not only is it specific with respect to insects as opposed to mammals, but it's also specific to the type of insect. Therefore, if they do this genetic modification and then release it into the environment so they have better control of spruce budworm, they are convinced there's a very low risk that it will spread to a non-target organism. But the risk is not zero. That's what we have to explain.
We have to explain why we're doing this. The control of spruce budworm is a very important benefit in Canada, no one can doubt that. I accept the argument that we really have to do this, otherwise we're going to run out of other options. I've been persuaded of that. I know they as scientists are convinced the risk of it spreading to even a non-target insect species is very low, but it's not zero.
The fear that we will release something and then it will do something quite bad that we hadn't anticipated is a legitimate fear. We can never get it back once we release it, unlike other things that we can correct. We can even clean up spills. We can reverse many of the older types of technology - in fact, chemical impacts - by stopping to do something. Even in the case of using DDT, say, with the environmental consequences, gradually, over time, that will disappear from the birds, and the raptors will come back, the falcons will come back, and so on.
The fear with this type of genetic manipulation is that once you get it out there, if something happens that you didn't anticipate, you can never get it back. So that's why we need a very enhanced level of both review and competence. I believe, in fact, the scientific assessment is no different from what we now do except that science always advances. But I think we need a much better level of public confidence so that we can have the best possible protection against those unforeseen consequences.
The Chairman: Thank you.
Madame Kraft Sloan, followed by the chair, unless someone else is interested....
Mrs. Kraft Sloan: Dr. Leiss, I was wondering if you could tell us who represents the public interest.
Dr. Leiss: You mean besides me? In my view, the public interest is the result of a process in which all interested parties are heard and taken seriously, and we make a judgment that changes over time as to what serves the common good.
These things change. For a long time there was a consensus of judgment in pesticides that it was best served by the old system in which Agriculture Canada administered the Pest Control Products Act all by itself. There was a perception that started in the 1970s and 1980s that, no, this was not in the public interest and should be different. We changed it once, then we changed it again.
So it's always evolving. But I believe it is the end result of an open, healthy, serious dialogue among interested parties and experts, inasmuch as you need them, through a democratic and parliamentary system. We're not perfect, but we do pretty well in that.
Mrs. Kraft Sloan: So you wouldn't necessarily say the environmental organizations or environmental law organizations serve the public interest in the area of the environment.
Dr. Leiss: No, they're interested parties. They have a point of view. I agree with some, and some I disagree with. We tend to call them public interest groups purely because they have no direct financial stake in the outcomes or positions they advocate, but they really are positions on things, many of which are strategic.
Greenpeace, which I think is a very effective organization, takes strategic positions all the time. The public views them as credible - perhaps a little too credible sometimes, because they make a mistake and they think they have no interest in this, but of course they have an interest in this. I think the public interest is the outcome of the interplay of all of these and should not be identified with any one party.
Mrs. Kraft Sloan: How do you ensure that there is a democratic process, and that it is fair and open?
Dr. Leiss: It's a continuous struggle. With pesticides, for a long time.... It was difficult to define how you would get a broader input into the system. People worked a lot on that. Then you get involved in highly technical questions - all this toxicology is confidential and we can't talk about it, and then there are solutions to that by signing confidentiality agreements. It is very difficult.
We also have a parliamentary political system in which responsibility lies with ministers, and accountability is ultimately to the electorate, so it's a bunch of trade-offs. I don't think we have solved that in risk areas, because you have to balance the need for making decisions and decisions for which someone is accountable with the level of input, because we also we derive immense benefits from all of these technologies.
If you look at engineered drugs and the prospect that genetically modified substances that replace traditional blood products will be a solution to the problem of sexually transmitted diseases for those who rely upon a regular supply of blood products - this is an incredible benefit. We see the tragedy of the Krever commission unfolding before us as we speak. That there are technological solutions that could lower the possibility of this ever happening again is very important. We have a great need for this, so we need a system that at least gets answers and gets them out, even if they are not perfect, and balance that against a wide variety of inputs. It's always a balancing act, and we're never there perfectly.
Mrs. Kraft Sloan: You have said that over time we changed what we believed to be in the public interest. Personally, I wonder if the public interest is being served.
Dr. Leiss: By...?
Mrs. Kraft Sloan: By some of these changing positions. Earlier you said that deregulation on this side of the border is a disease that is somewhat limited. I see it in a more unlimited fashion, and I'm not so sure. I'm not suggesting that you regulate for the sake of regulation, and I agree with you that we should look at more credible and effective regulation.
Dr. Leiss: We don't need deregulation in Canada, we need more efficient regulation.
Mrs. Kraft Sloan: I agree with you. So when the overall climate is around deregulation, and when we are on the verge of a new century where we're going to be dealing more and more with transgenic entities in biotechnology, where you have suggested we need more caution because of anomalies, I think the public interest position may be shifting into a precarious....
Dr. Leiss: I believe that in the case of blood products, we can show immense human benefit from the...we need these types of things. If the perception on the other side is that the objective is to slow the system down so much that nothing is ever approved, then I would not agree with that. I don't think we have that problem. I do not think we need a less regulated system but one that is more efficient and more credible, and we can get it.
Mrs. Kraft Sloan: Why do you feel this system would be better for industry?
Dr. Leiss: Because in the end I think they will benefit from a system that has higher public credibility. Even if we have unforeseen consequences - nature is like that, it springs things on us - we can say we looked at every aspect, and according to our knowledge base we did our best. I think the public would say, okay, you weren't in there confused about whether you were a promoter or a regulator, you took that responsibility very seriously, that was a mistake. It's bound to happen, but it will not call the system into question.
Mrs. Kraft Sloan: If this is better for industry, why is there such an intense industry lobby to avoid the kind of thing you are talking about?
Dr. Leiss: They don't know what's in their best interest, I'm afraid.
Mrs. Kraft Sloan: So how do we argue the public interest position if it's a discussion among stakeholders?
Dr. Leiss: Just keep hitting them over the head.
The Chairman: That's why we have politicians who are elected representatives.
To conclude, Dr. Leiss, could there be a situation whereby you have a product that is partly traditional and partly new? If so, would a proponent of such a product have to be shopping twice under any regime?
Dr. Leiss: It would fall under one or the other. In the examples that I gave on page 13, I said that all legislation to some extent is arbitrary. It defines ``boxes''. As long as it is clear whether you're in the box or out, that's the important thing. So there will be grey areas. The provisions have to be clear enough to say that if we're doing this, we're either in there or out, and as long as you are, it's one or the other but not both. That's necessary for efficiency.
I gave you the controversial example of rBST. That is not, as I understand it, a transgenic entity. It is controversial, but for other reasons. It doesn't fall into the new box, but that's okay as long as you know what box it's in.
The Chairman: Thank you.
Are there any further questions? If not, I thank you on behalf of the committee. This was a very productive morning. Maybe we will set up another gathering with a larger group of witnesses, perhaps in the form of a round table in September, to go further into this alternative approach, which some of us at least find extremely interesting.
Dr. Leiss: Thank you.
The Chairman: This meeting is adjourned.