ENVI Committee Meeting

STANDING COMMITTEE ON ENVIRONMENT AND SUSTAINABLE DEVELOPMENT

COMITÉ PERMANENT DE L'ENVIRONNEMENT ET DU DÉVELOPPEMENT DURABLE

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, March 13, 2001

• 0904

[English]

The Chair (Hon. Charles Caccia (Davenport, Lib.)): Welcome to our meeting today. This is a very important gathering, and we are extremely grateful to the witnesses for making it possible.

The report before us is of enormous significance, and it is one that I'm sure every member of the committee will want to become very familiar with. Its implications and recommendations are far-reaching.

• 0905

Because of weather conditions, one witness is delayed, but it would be a pity not to make good use of the limited time available. Two witnesses are here, so if there is agreement around the table, I will launch the meeting and welcome Monsieur Fortin, as well as Mr. Ellis.

The background of Monsieur Fortin is probably known to many of you. He comes from McGill University, where he teaches at the plant science department. He received his doctorate in plant molecular biology in 1987 and did post-doctoral work at the University of Chicago and the University of California. His research focuses on applying molecular genetics approaches to the better understanding of interactions between plants and microbes, and he was one of the initiators of the news of DNA markers for plant improvement. He is an adviser to several provincial and national organizations dedicated to researching plant science.

As for Dr. Ellis, he comes from UBC, where he received his doctorate in 1969 and was head of the department of plant science from 1989 to 1999. Plant metabolism, especially lignin biosynthesis, is his particular interest. His current projects include biochemistry of metabolic enzymes, signalling mechanisms whereby plants sense and respond to environmental changes, oxidative stress, and genetic engineering of crop and forest plants. He teaches sustainable agriculture and professional communication, as well as plant breeding and plant and microbe interactions.

You can appreciate that they live in a world that is not very closely reminiscent of the world in which we live, which makes it even more necessary to communicate.

Here we have our third witness, I suspect, and that is Dr. Brunk—welcome to the committee. He is academic dean and professor of philosophy at the Conrad Grebel College of the University of Waterloo. He was awarded a doctorate in philosophy in 1974 at Northwestern, and he has been teaching at the University of Waterloo since 1976. His areas of specialization include applied and professional ethics, environmental and biomedical ethics, and conflict resolution. He produced a book entitled Value Assumptions in Risk Assessment in 1991. He served as chair of the Royal Society of Canada's expert panel on the future of Health Canada's non-human primate colony in 1996.

Welcome to you all. Perhaps you may decide among yourselves how you want to proceed.

Professor Conrad G. Brunk (Academic Dean and Professor, Philosophy, Conrad Grebel College, University of Waterloo; Royal Society of Canada): Thank you very much. I am happy to be here finally, after a late flight, a cancelled flight, and a traffic jam.

I understand you would like us to make a presentation—of approximately how long?

The Chair: There will be many questions—keep that in mind. We have two hours, so maybe you can limit the totality of your presentations to no more than half an hour.

Prof. Conrad Brunk: We should be able to do it in less than that. We'll aim for that.

Our objective is to give you a brief overview of the report we submitted. I will begin by clarifying the terms of reference. That is very important, as I think there has been some misinterpretation of the report because of a lack of understanding of what our terms of reference were.

• 0910

We will clarify that, and then my colleagues will talk about some specific issues that are central in our recommendations in the report. Dr. Ellis will talk particularly about the issue of substantial equivalents, which was one of the major issues we dealt with. Then Dr. Fortin will speak about some of the specific scientific recommendations we made.

I'll begin by clarifying our terms of reference. I believe all of you have the notes from which we will be making our presentation, and you can follow along.

We were asked by our sponsors to forecast several items: first of all, the types of biotechnology food products being developed for future review, and secondly, the science likely to be used to develop these products—

The Chair: Excuse me for interrupting. For the benefit of our colleagues, Dr. Brunk is reading from the paper you have and from the page entitled “Terms of Reference”. Is that correct?

Prof. Conrad Brunk: Right.

The Chair: Thank you.

Prof. Conrad Brunk: Thank you. Our presentation will be following through these notes.

Thirdly, we were asked to forecast the potential short or long-term risks posed by development, production, or use of these products in three areas: risks to human health, risks to animal health, and risks to the environment. We were then asked to assess the approaches and methodologies developed in Canada and internationally to evaluate the safety of foods being developed through biotechnology—for example, the standards being developed at the level of the World Health Organization, FAO, and the Codex Alimentarius Commission.

We were asked to identify the scientific capacity that will be needed to ensure the safety of new foods derived from biotechnology, including human resources for research, lab testing, safety evaluation, and monitoring and enforcement, and then to identify new policies, guidelines, and regulations related to science that may be required for protecting human health, animal health, and environmental health.

You will notice that the mandate focuses narrowly on the question of the scientific capacity required to identify the risks that the expert panel thought would be associated with the coming technologies. The mandate is future-oriented; it is not past-oriented. We were not asked to critique the regulatory system that has been in place in the past in terms of the approval of the products that have been approved so far on the market. We did understand our mandate to be very future-oriented, and of course it is very narrowly risk-oriented.

It is important to understand that the mandate we were given did not include the following issues. It did not include the evaluation of the socio-economic benefits of current or future agricultural biotechnology products. We did not have expertise on the panel who had the competence to make evaluations of the economic, political, or social benefits of these agricultural products. Had we tried to do it, we wouldn't have had the expertise to do it, and our mandate did not ask us to do it. We were not asked to consider the broader ethical issues raised by certain types of biotechnology products or of the technology per se.

We looked only at the ethical issues and the value questions that are relevant to the management of health and environmental risks, those that we felt were essential to framing the science issues and putting them into a policy context, into a regulatory context. But the larger ethical issues about the overall value or whether or not there are certain questions of rights and entitlements associated with biotechnology, we did not consider. We did not consider the larger philosophical, religious, and metaphysical concerns that are very much a part of the public debate about biotechnology, especially in the area of medical biotechnology, but also in the area of agricultural biotechnology.

• 0915

As a consequence, it is important to understand that the report of the expert panel makes no claim to provide a comprehensive assessment of the social, economic, or ethical acceptability or desirability of biotech food products in general. We were not asked to make an overall judgment about the desirability, the risk-benefit equations, and so on with regard to agricultural biotechnology. Because we were not asked to assess the benefits and the claims that are made about the benefits of the technology, we cannot say that the report provides a full safety assessment of these products either. In some cases it is, of course, widely recognized that the issue of safety involves the balancing of risks against the benefits of a technology. Because we did not consider benefits, we were not able to conduct a full risk-benefit analysis, and therefore we could not claim we had done a full safety evaluation of these products. We were asked to look at the risk side of the equation.

We did look at the safety issues related to the often-invoked standard of substantial equivalence, which does not involve an appeal to benefits. So to that extent we looked at safety standards, but not at all safety standards.

I'd like to say a few words about the procedures that were followed by the panel in putting together the report. The expert panel was requested by Health Canada, the Canadian Food Inspection Agency, and Environment Canada. These agencies went to the Royal Society of Canada and asked it to make use of its regular standing policy to put together expert panels in response to requests from industry or government to provide an arm's-length, objective opinion on particular issues.

This is done by a standing committee on expert panels that is maintained by the Royal Society of Canada. They have a rather extensive selection process for identifying people who are at arm's length and who are experts in the fields required by the mandate, and the members of the panel are chosen by this committee on expert panels.

In our case, 12 scientists and two policy experts in the area of law and ethics and regulatory policy were chosen. In a moment I'll refer to the scientific expertise that was represented.

The committee on expert panels seeks to find people who are at maximum arm's length from vested interests in the issue that's being considered, in this case people with very clear vested interests in biotechnology. There are very strict conflict-of-interest requirements imposed on the members, and these were followed.

You have on the following sheet the list of the members of the panel. These are listed primarily to show you the areas of expertise that were represented on the panel. We had a botanist, a nutritionist, an ethicist, a specialist in law and ethics, a plant biochemist, a plant molecular biologist, an allergist, a marine biologist, an animal nutritionist, an entomologist, a toxicologist, a microbial ecologist and biologist, and a food scientist. These were the disciplines that were represented on the panel. I think we had a very excellent panel, which was a great pleasure to work with.

You have on the next two pages the chapter titles, which give you a picture of the issues we dealt with in the report.

• 0920

In chapter 1 we clarified the limitations and the expanse of the mandate, and also we clarified certain questions concerning the relationship between science and other issues, and how we would handle them in the report.

Chapter 2 focused on the development of the technology, looking at the past and projecting into the future.

Chapter 3 is a short review of the regulatory environment in Canada.

Chapter 4 gets into the substantive risk issues. It looks at the human health issues. It's divided into three sections. The first looks at the toxicological issues involved in biotechnology, the second at the very important issue of allergens in foods, and the third focuses on the nutritional changes introduced and their impacts on human health.

Chapter 5 was devoted to animal production systems and the question of animal health, looking at genetically modified animals, including fish—an important issue here, because fish represent the area where genetic modification is most advanced and closest to commercial stages of development. We also looked at genetically modified feeds, additives, and metabolic modifiers and their impact upon animal health.

Chapter 6 focused on the environmental risks, looking at micro-organisms and soil, genetically modified plants and their environmental ecological effects, the impacts upon insects—the entomological risks—and then there is a special section on genetically modified fish and their environmental impacts, because of what, as I previously mentioned, the panel judged to be the importance and immediacy of this issue.

Chapter 7 picks up the very controversial and important issue of substantial equivalence, which is a guiding concept, both nationally and internationally, in the regulation of biotechnology.

Chapter 8 looks at the precautionary principle, which is widely claimed as a guiding principle, but varies widely in its interpretation and of course is very controversial. We devoted a great deal of time trying to understand and lay out how the precautionary principle should be used in a regulatory context. It is, I think, one of the most detailed discussions of the precautionary principle you'll find in the regulatory literature, and in the reports dealing with biotechnology certainly.

Then chapter 9 deals with what we felt were important issues related to the integrity of science and public confidence in a science-based regulatory system.

There are four categories of recommendations in the report: those concerning underlying policies and principles in the regulation of biotechnology; recommendations relating to specific guidelines and regulations we would like to see in the Canadian system; a section of general recommendations about how the regulatory process should be handled; and finally recommendations broadly related to development of scientific capacity in the society in general, in order to provide the basis for a science-based regulation of biotechnology.

I will now turn to my colleague, Dr. Brian Ellis, who will tell you a bit about how we handled this important issue of substantial equivalence.

The Chair: Professor Ellis, please.

Professor Brian E. Ellis (Associate Director, Biotechnology Laboratory, Professor, Faculty of Agricultural Sciences and the Biotechnology Laboratory, University of British Columbia; Royal Society of Canada): Thank you.

The substantial equivalence issue is deeply embedded in the current regulation of biotechnology products. It derives, from the panel's perspective, from the history of development of new crop varieties through classical breeding, where the breeder typically makes crosses between known varieties and selects amongst the progeny that are developed from those crosses, but assumes all the way along the path that they're effectively dealing with the same material they started with, just some slight changes in it. Therefore, the progeny, the new varieties that are developed, are considered to be effectively equivalent to the parents but slightly improved.

• 0925

The paradigm for genetic engineering is that instead of mixing large numbers of genes from two parent types in a cross, one would simply move in a single gene or a very small number of genes using gene transfer technology, and the rest of the genetic background of the material that's in use would remain unaltered. On the face of it, this is a very simple and precise methodology, because you don't have a large mixture of genes, a lot of genes interacting, and the assessment of this transgenic or genetically modified material, in principle, could be viewed as simply requiring an assessment of whether the new gene has introduced a trait that would have been predicted and whether that trait has any negative consequences in terms of food safety or environmental impact.

This is the effective structure of a substantial equivalence evaluation, that if the new gene can be demonstrated to have no negative impacts, then the rest of the genetic material you're working with there is substantially equivalent to the parental material from which it was derived by gene transfer. Therefore, by invoking a substantial equivalence declaration, the assessment of the material can stop at the end of having examined the effects of the new gene.

Where the panel found this to be perhaps inappropriate is related to the fact that when you put new genes into an unusual genetic background from the context of that particular gene that's coming in, which typically comes from a very different genetic source, it's very hard—as a matter of fact, impossible—to predict the interactions between that new gene and the existing genes within the material that have been transformed. Those interactions are likely to have quite a wide range of effects, some of them quite minor, but potentially some of them more substantial. Unless one examines the genetically engineered material, the genetically engineered products, with a very wide screen, it's entirely possible that you would miss some of these secondary effects of having the new gene in that background.

Therefore, the distinction the panel finally came down to was this: If one does a very wide and rigorous screen, a scientific assessment, of the genetically modified material intended specifically to pick up any secondary effects that might have resulted from that transformation, then at the end of the day it would be appropriate to designate that material as being substantially equivalent if no such negative secondary effects have been observed. On the other hand, it would be considered inappropriate, from the panel's perspective, to simply take the view that if we've assessed the direct impacts of the new gene, then the rest of the genome of the transformed material can be considered to be the same as the parental material, unaltered and of no consequence.

So this is the distinction the panel finally came down to, that using substantial equivalence as a decision threshold—that is, because it is a single genome transferred within a new gene, once you've looked at the new gene, the rest is okay—was an inappropriate use of the concept. On the other hand, to carry out a rigorous review of the material, carefully checking all its potential impacts and then determining a priori that it is not different from the parental material, that would be an appropriate use of substantial equivalence. That says, yes, it is very, very similar to the parental material and differs only in a specific outcome that was predicted and has been demonstrated. So that's the distinction the panel feels is appropriate.

It wasn't clear to us, from our examination of the procedures that are in use right now in approval of genetically modified crops, in particular in Canada, just exactly how the substantial equivalence principle was being used. It shows up in the flowcharts for the approval process as being a discrete step, at which point a decision is made either to forego any further assessment, or, if it fails on a substantial equivalence assessment, it then goes to a full environmental assessment.

• 0930

In our discussions with the personnel from CFIA who are responsible primarily for screening crop materials, it wasn't clear to us exactly how they employed that particular principle.

So the panel simply came to the conclusion that in the future at least, in the regulatory process that should be in place, there is no reason to bypass any thorough scientific review of the material simply because it results from transformation of an existing genotype with one or two new genes. That in itself does not provide any reason for foregoing a full assessment of all the consequences of that transformation.

Therefore, the requirement is still for a full and rigorous assessment of any transgenic material that's been developed. I think I will leave it at that.

The Chair: All right. Thank you, Dr. Ellis.

Mr. Fortin.

[Translation]

Professor Marc G. Fortin (Associate Professor and Dean, Plant Science Department, McGill University, Royal Society of Canada): The scientific recommendations of the expert panel are premised on the belief that scientists do not have all the answers when it comes to the safety of GMOs and their effect on human health and the environment. We don't have all the answers. The scientific community is uncertain about the safety of GMOs.

The panel's recommendations speak to the need to find answers and to reduce this scientific uncertainty. More research is needed and that's one of the panel's main recommendations. We don't have the answers. Research needs to be conducted and we have put forward a series of recommendations on the approach that should be taken.

In order to conduct this research, we need to call upon the best possible expertise available in Canada. Canadian researchers currently do not have the financial resources to do research on GMOs. The research must be carried out by independent researchers with no ties to either proponents or regulators of the technology. We must adhere to the following basic scientific principle: researchers must be independent of proponents of biotechnologies. One cannot be both judge and jury.

Stringent research principles must be applied to research on GMOs. Regarding the regulatory process itself, we must follow rigorous, generally accepted scientific principles. The regulatory body must not be perceived as having any conflicts of interests with the companies promoting the technology. The scientific data on which regulatory decisions will be based must be accessible to everyone. The process must be transparent.

The Canadian Food Inspection Agency is currently perceived as a body that operates behind closed doors. I repeat, this is merely the public's perception.

To begin with, scientific data on which decisions about the safety of GMOs are based must be accessible to everyone, including the best possible experts on the subject.

Secondly, the veil of secrecy currently surrounding the regulation of GMOs must be lifted. It only leads to distrust among consumers and to uncertainty over the safety of these products. Scientists do not have access to the data used by the Canadian Food Inspection Agency and this raises doubts in their minds as to the validity of the process. And, while the process may indeed by valid, the inaccessibility of the data creates the perception of a hidden agenda.

The message can, therefore, be summed up as follows: an independent evaluation is warranted, along with independent research into the safety of GMOs. Generally applicable rigorous scientific processes must be implemented, for example, peer review. The transparency of the process must be improved in order to make the data available to everyone.

• 0935

Canada is not alone in confronting challenges of this nature. Various countries around the world are facing similar problems. We don't have any scientific answers about the safety of these products. The challenge is the same for all countries, namely to conduct research following stringent parameters. The recommendations formulated by the expert panel of the Royal Society of Canada reflect the recommendations of other commissions and study groups on the regulating of GMOs, in particular those of a group comprised of representatives from the United States and the European Union.

I remind you that the United States and the European Union have been trade partners with radically different positions on the GMO issue. This group made recommendations concerning the need for scientific research which are quite similar to those formulated by the expert panel of the Royal Society of Canada.

A consensus is emerging around the world on the need for independent, impartial and transparent research subject to peer review.

I will dispense at this time with listing all of the scientific recommendations formulated by the panel. Instead, I will focus on a handful that highlight research needs, for example, the need to develop protocols for allergenicity assessments of new proteins produced in GMOs. The necessary protocols for conducting tests of this kind and for assessing in a reliable manner the potential allergenicity of new proteins do not exist. This is a challenge confronting the international research community, not merely researchers here in Canada.

However, it's important that Canadian researchers participate in international research efforts so that Canada can maintain its standing as a leader in the field of food safety. We must establish a program to monitor the long-term effects of GMOs. Today in Canada, there is neither the scientific capability nor adequate funding to set up such a program to monitor the long-term effects of GMOs on human health and the environment.

Research stations are needed to assess the effects of GMOs on the environment. As Professor Ellis stated, we need to move quickly to develop assessment protocols for transgenic animal and fish. We know that these products will be appearing in the near future on store shelves and as we speak, no regulatory regime is in place.

The panel also calls for a moratorium on the rearing of GM fish in aquatic pens. Concerns have been voiced about how transgenic fish will impact wild fish populations.

Again, we don't have answers to these questions. While some concerns have been expressed, we're not saying either that GMOs will prove to be harmful to human health and the environment. We're saying that from a scientific standpoint, some uncertainty prevails and scientific doubts must be dispelled though research and the adoption of rigorous scientific procedures.

Our message today is basically this: given the uncertainty and lack of answers within the scientific community, a cautious, circumspect approach is warranted.

Thank you, Mr. Chairman.

The Chair: Thank you, Professor Fortin.

[English]

I don't need to stress how exciting and significant this interface between science and politics and policy-making is—perhaps one of the most interesting in the history of mankind.

While listening to the three of you, I couldn't help recalling an article that appeared in late January in the Herald Tribune, I believe, on Monsanto—which probably many have read—and how they have attempted to organize a regime over the last ten years on their work and commercial initiatives in relation to GMOs. For those who haven't seen it, I'm sure you would derive a great insight by reading that article, because it shows the enormous commercial interests that are attached to this particular kind of research, and the political implications, of course.

• 0940

So we have here a good list of your interventions or your presentations. Certainly they will trigger interesting and far-reaching questions.

We will start in the usual way, beginning with Mr. Forseth, followed by Monsieur Bigras and Monsieur Comartin, and then Mr. Knutson. That is who I have so far on the list, along with Mr. Reed and Madame Redman.

Mr. Forseth, would you like to start your first five minutes?

Mr. Paul Forseth (New Westminster—Coquitlam—Burnaby, Canadian Alliance): Thank you very much, and welcome.

I see in your notes that you say, “`Substantial Equivalence' should not substitute for rigorous testing of new products”. Of course, we're always looking at the profit motive for the shortcut to bring things to market and to take advantage. Also, there's the competitive advantage between competitors to be first and to dominate a market.

You've talked about the need for resources and also for the law or the regulatory climate. I notice that on page xv of the executive summary of special recommendations, in recommendations 4.5 all the way down to 7.5, many of those recommendations have the same tone: “...the establishment of comprehensive research...”; “...recommends that a federally multidisciplinary research initiative be undertaken...”. Each of these recommendations outlines huge agendas of things that need to be done, and I suppose that, based on the tone of them, in essence a lot of them are not being done.

So that outlines almost an overwhelming vision, but we have difficulty in competition for resources, of course, especially in the regulatory climate. These kinds of things often have to be done by government, especially in terms of setting the legal context and the regulatory context, and trying to partner with industry.

I just want to ask you to comment on something. Given Canada's size economically, is it really realistic for us to go it alone with these great big objectives? How are we actually ever going to get to the scientific standard of safety when, based on the past track record, we know the ability to get resources to bear and for Parliament to move sufficiently quickly to develop the regulatory and legal climate? Instead of outlining the wonderful banner of what we need to achieve, have you given any thought to some suggestions about how we might be able to get there and get there more quickly? What about this concept of not necessarily going it alone, but finding international partnerships so that we can actually get something done, get something protected, rather than continuing to shuffle along always after the fact?

The Chair: Thank you.

Who would like to comment?

Prof. Brian Ellis: I think you've identified a very key issue. It's one big world, and it's a world in which the American marketplace dominates and American technology dominates, so it's a challenge to decide how far Canada can push the envelope on its own. There are some issues that Canada has a unique interest in. As a matter of fact, I think it could and must examine, for instance, environmental impacts in Canada's own context, in its own landscapes. And Canada has a unique interest in a certain small number of crops. For instance, canola is the classic example, and wheat would be another major one.

• 0945

So one way in which Canada, I think, could proceed is to pursue a course of doing exemplary work in targeted areas of particular interest to it, while at the same time working toward a strong international agreement that would hopefully reach a consensus on the level of science that will be acceptable internationally.

I don't think there's any black and white answer to this issue. You can't throw money at it endlessly and hope you'll arrive at some nirvana of regulatory safety, but I do think there are places where we could make an effort as a country and demonstrate some leadership, both on the impacts and on the assessment of the transgenic materials themselves.

My colleague may have....

Prof. Conrad Brunk: If I could add to that, I think we are, as a country, spending a lot of money to support research in the development of the technology. One of the things we called for is a balance in the resources provided for the research, so we make sure that those resources are also spent for independent research on the safety side, and not just the development side of the technology. That, I think, we do have a national obligation to do.

Mr. Paul Forseth: Several times the notion of independence has come up as a real concern. Is that a problem right now, especially on the approval and the analysis, the looking at the precautionary side of things? Is there a real difficulty of not having neutrality, or not having independent evaluation?

Prof. Marc Fortin: I sat for three years on the National Science and Engineering Research Council panel for grant allocations in plant biology and food science, and two years ago, across the country, no one was doing research in universities in the area of genetically modified plants. From traditional sources of funding we simply do not have the resources to do that kind of research in universities. Again, this is one component of the research machinery. We don't claim that universities are the be-all and end-all of research, but university researchers, by and large, have more independence than several other members of the research community. We should exploit this expertise and this knowledge that is out there. We should give it the resources to do the work.

Prof. Brian Ellis: Let me add something to that, because I think there's a broader issue that perhaps you were addressing, and that is the degree of independence in the existing regulatory system. I think the panel felt very strongly that—without casting any aspersions on the current regulatory staff—they are under enormous pressure to meet the needs of the business community submitting these materials. I think they strive very hard to strike a balance between the needs of that community and the public they are basically in place to protect. It would help that process tremendously, given its intrinsically confidential nature, if there were an independent, publically trusted review mechanism that could take a look at those decisions and say, yes, they were taken with good reason and on the basis of solid scientific evidence. If this group, whatever it might be, had that public trust, I think it would make a tremendous difference in the acceptability of the adoption of these technologies in the general public's mind.

Mr. Paul Forseth: I see developing in the community a lot of non-government organizations or particular groups that are running around saying the world is coming to an end and we've got to be very careful about all of this from the community political development/organization side, groups especially opposed to even the contemplation of research in this area.

• 0950

So certainly, independent public safety mechanisms have to be addressed by government. I'm not so sure that government, with its internal expertise in the ministries, really can find its way. It's going to have to....

Typically our history is that we've stumbled along with disjointed incrementalism, making it up as we go. Do we have to continue to be that way, or can the Royal Society or others more forcefully point in a direction and say “Get going”.

The Chair: That is the particular purpose of this report, and that's why we're beginning to analyse it.

Mr. Paul Forseth: Just one little comment to that, and then I'll end my turn.

The Chair: Is there a brief comment, please?

Prof. Marc Fortin: One of the recommendations points to the creation of advisory bodies—using, again, the best expertise we have in Canada—to look at specific genetic modifications and specific areas and, in conjunction with Health Canada and the CFIA, to put forward some recommendations on how to implement a safety assessment protocol for a series of genetic modifications.

The Chair: Thank you, Mr. Forseth.

Mr. Bigras, followed by Mr. Comartin, Mr. Knutson, Mr. Reed, Madame Redman, Mr. Charbonneau, and the chair.

[Translation]

Mr. Bernard Bigras (Rosemont—Petite-Patrie, BQ): Thank you very much, Mr. Chairman.

First of all, I'd like to thank you for coming here to summarize your report for our committee.

You stated rather emphatically that there was a world of difference between the assessment protocols in the agri-food industry and those in the pharmaceutical industry. You also stated that the tests for new products are not yet ready. You also believe, as I do, that the certification process for transgenic products should be the same as the current drug licensing process.

My question is straightforward: If we were to adopt the system that you are advocating here today, how many GMOs would not have been approved for use? For example, would genetically modified corn have been approved? Which food products would have been rejected? How many such products would have been rejected overall?

Prof. Marc Fortin: I'd like to correct something. In the report submitted by the expert panel from the Royal Society of Canada, we do not recommend the adoption of assessment protocols similar to the ones used in the pharmaceutical industry. We call for the development, with the help and participation of the scientific community, of scientifically rigorous protocols which may differ from those used by the pharmaceutical industry.

Furthermore - and this was clearly spelled out in our mandate—we did not examine products that are currently on the market. Rather, we considered those products likely to be submitted for approval in the future. We did not look at products currently on the market.

Mr. Bernard Bigras: I see. That doesn't really answer my question, but no matter.

The Chair: Would you care to repeat the question?

Mr. Bernard Bigras: Even if I were to repeat it, I don't think I'd necessarily get an answer.

I'd like to focus on substantial equivalences for a moment. Correct me if I'm wrong, but you are opposed to the use of this concept for decision-making purposes because you find the concept somewhat unclear. For example, a genetically modified tomato might be deemed the equivalent of a traditional tomato. Again, as I understand it, you would like to see each assessment better documented do that better decisions can be made, either through protein analysis, genetic analysis or some other test.

• 0955

You stated earlier that researchers do not have the resources to conduct these tests. In fact, isn't the concept of substantial equivalences being used merely to justify the fact that there are no thorough tests available to be done in Canada?

Prof. Marc Fortin: The principle of substantial equivalence is applied several ways in Canada and some rather lengthy discussions have ensued. The debate is rather interesting and I invite you to read about it in the expert panel's report which will be available shortly in French.

I may be overly simplifying matters, but to illustrate the different ways in which the principle of substantial equivalence can be applied, consider the following: a genetically modified tomato may not appear to have any harmful effects on the environment. Therefore, it may be deemed substantially equivalent, because of its apparent lack of harmful effects. Conversely, a tomato's protein, genetic and chemical components may be analysed and the determination made that to the best of our knowledge, the transgenic tomato is substantially equivalent to the non genetically modified tomato.

These are two different philosophical approaches to applying the principle of substantial equivalence. We favour the second approach, i.e the one that determines equivalence based on the knowledge currently available.

Mr. Bernard Bigras: Another issue is the lack of transparency and conflicts of interests. You broach this subject in a rather interesting way in your report. The whole relationship between the company and the researcher needs to be considered. You're calling for independent research to be conducted, inevitably by universities.

Do you not see the inherent contradiction in this position? The Chairman mentioned Monsanto. It's fairly obvious that the research should not be conducted by a firm's researchers, or even by university researchers, for that matter, but rather by the government. Perhaps this approach would lead to better results.

Prof. Marc Fortin: I'm quite confident that there are a great many university researchers who have no ties to industry and who are quite capable of conducting first-class independent research.

Your concern, namely the growing influence of commercial research on federal and provincial government subsidy programs, is addressed in the report.

We identify this as a concern, not as an indication of any inability to do research. It is in fact a mounting concern. It remains to be seen to what extent commercial agendas will drive research on a national scale. However, this is not an indication of any inability to conduct independent research. Some caution is in order. Any research that may be done by governments could be perceived as being partial if the government was seen as a proponent of biotechnology.

Mr. Bernard Bigras: Do I have any time remaining?

The Chair: Two minutes.

Mr. Bernard Bigras: On the issue of whether or not the report is realistic, something alluded to by my Canadian Alliance colleague, inevitably, the process that you are recommending would lead to more studies before a final decision is made. Inevitably as well, it would further delay product certification and result in additional costs to companies.

• 1000

Basically, I have more or less the same question for you as my colleague. Often, the only interests companies have are of a commercial nature. This proposal is not out of the realm of possibility given the reality of business and the economy in Canada and, to a certain extent, North America. Wouldn't you agree?

[English]

Prof. Conrad Brunk: I'm not sure that a group of scientists are really qualified to answer that question, and I will refer to the mandate again and the fairly narrow terms that our mandate set for us, which I don't think really gave us the expertise on the panel to answer those broader economic questions. We were asked to comment on what kind of science would be required to do it in a way that we think is protecting the public adequately from the risks that may be involved here. I suppose one could say it might be for others to decide the extent to which those kinds of scientific requirements that we identified need to be compromised by other political and commercial interests.

That is the basic answer that would have to be given to your question, though I think we also identified the fact that as these new diagnostic techniques are being developed, which we are recommending for rigorous testing of these products, and as they become standardized, they may well indicate that there are not real problems here and that the approval process could be more streamlined because we really do know what we're doing because we've tested to see. And as these new diagnostic technologies come into play, it will not be that expensive and arduous a process doing the kind of testing the panel called for.

[Translation]

The Chair: Thank you, Mr. Bigras.

[English]

Mr. Comartin.

Mr. Joe Comartin (Windsor—St. Clair, NDP): Thank you, Mr. Chair.

I think, Dr. Fortin, you commented about the lack of research done at the university level up to this point. Regarding the review process that's being suggested here, do we have the expertise? Do we have enough scientists who would be independent from commercial interests to do that review process at this time?

I'm asking you about the independence issue, the lack of conflict of interest, and the technical expertise. Do we have that kind of ability in Canada at this point to do the review?

Prof. Brian Ellis: It's important to draw a distinction between actually doing the testing and reviewing the testing. If the testing all had to be done at a university, I think there could very well be some shortage of personnel and resources.

The second model, in which university personnel experts review testing, both how the testing is designed and how the data is analysed, that certainly would not be out of the question. That's probably a more realistic model. A lot of the research is currently done at universities, of course, under contracts to the companies, and therefore the data is being generated by university researchers in some cases. But, of course, there it's all done under confidentiality agreements, so none of that data becomes publicly accessible.

But to go back to your original point, I think the expertise is there if it's deployed in an efficient fashion.

The other thing I would comment on, though, is that the diagnostic technologies that Dr. Brunk has referred to are relatively new; therefore, what we're looking forward to, as a panel, is a scenario in which we will have far more powerful tools to get these questions answered than they had available five or ten years ago. Times are changing, and it was the panel's view that our assessment methodologies should be changing as well.

• 1005

Mr. Joe Comartin: Internationally, are there any other countries looking at this kind of review or, more importantly, has anybody begun to implement that kind of a review process at the national level?

Prof. Conrad Brunk: Yes. There are reports like ours appearing at the request of most national governments. Just prior to the publication of our report, the National Research Council of the United States issued a similar report, and, I might say, with many similar recommendations to those that appear in our report. There's a consultation report issued jointly by the European Union and the United States, which is in fact very similar in its conclusions to our report. There are other national bodies and international bodies doing the same thing.

Mr. Joe Comartin: The recommendation you made with regard to the moratorium on the use of genetically modified fish, or cultured fish—have you had any reaction to that from the industry? What I'm really asking is, has there been any negative or an attack type of a response that your recommendation is without foundation?

Prof. Marc Fortin: Well, transgenic fish has not been submitted yet for approval. So it's not been released yet. We believe an application for release will be submitted shortly. But it hasn't been submitted yet.

Mr. Joe Comartin: That's all, Mr. Chairman.

The Chair: Thank you, Mr. Comartin. Now we have Mr. Knutson, followed by Mr. Reed, Ms. Redman, Mr. Charbonneau, and the chair.

Mr. Knutson, please.

Mr. Gar Knutson (Elgin—Middlesex—London, Lib.): Thanks very much, Mr. Chairman.

Gentlemen, I have a number of questions, so I wonder if we could move through them as quickly as possible.

The first one is more an observation. You spent a fair bit of time outlining your process and sort of giving us a table of contents of how you went through your analysis, and then you jumped to your recommendations. I haven't read your report, and I just found today's presentation a little light on findings. I don't know if there was a reason for that. I don't know if I'm supposed to assume that all these recommendations are attached to a finding.

For example, the need for regulatory neutrality. Am I to assume that currently our regulatory process isn't neutral? Did you find that?

Prof. Brian Ellis: That's a very difficult thing to assess. I think there is a perception that the regulatory process is susceptible to being non-neutral. That's pretty vague language, I know. But the difficulty is that because it is a confidential process and because it requires very close and ongoing interactions between the regulators and the proponents of the technology, with no outside assessment of how that process goes or whether the outcome was appropriate or not, it is a perceptual problem at the end of the day.

Mr. Gar Knutson: The gist of what I've heard you say is that technology is way ahead of the regulatory process. I find that.... I'm not sure if I heard properly.

Prof. Brian Ellis: I'm not quite sure how one defines “way ahead”, but the technology is moving very fast.

Mr. Gar Knutson: For example, I think we mentioned that we didn't have protocol to determine whether these things cause allergic reactions in some percentage of the population. That would be—-

Prof. Brian Ellis: That's actually a place where the technology is not ahead of the regulatory process as much as the technology itself needs to be developed. From the panel's perspective, there is not enough research attention being paid to monitoring the development of allergenicity and predicting the allergenicity of novel proteins. So that was a research deficiency from the panel's perspective.

Mr. Gar Knutson: It's a research deficiency because the regulatory process doesn't mandate, doesn't command, that we do that research. Is that fair?

Prof. Brian Ellis: That's probably one of the reasons it's lacking research funding, yes. Certainly if the regulatory process demanded a higher standard with respect to allergenicity prediction, there would be more funding going into that.

• 1010

Mr. Gar Knutson: On the issue of confidentiality, I take it the big argument against it is commercial rights. Do other countries have a more open and transparent system that we should be adopting?

Prof. Brian Ellis: It varies from country to country. The American system, for instance, is more open than Canada's. But there is no country that gives wide-open access to commercial information and it is unrealistic to expect that it would.

There is, however, a very strong envelope of confidentiality wrapped around confidential business information in Canada, and it really does hamper the ability of the regulatory agencies to provide the public with concrete evidence that the regulatory decisions are appropriate. So I think even they find it frustrating that they have to keep so much of what they deal with under wraps, even information that patently is of little consequence from a commercial point of view, but because it was submitted by a company under CBI rules, it's automatically shielded.

Mr. Gar Knutson: My point is, from a public policy point of view it's easy to make the argument that if the Americans are doing it and the western world has a more open system, we should too. So I'm asking you, do other countries have a more open system?

Prof. Conrad Brunk: I wish our lawyer, who's a specialist in this area, were here to answer that question. But we on the panel heard his discussion of this, and his view expressed there was that there are other countries, for example, the United States, where because there is stronger patent protection for confidential business information, the regulatory processes can therefore be more open because that information is protected better at other levels—the implication being that because it is not protected as well in Canada, the regulatory process tends to be more closed.

Mr. Gar Knutson: Okay.

I don't know how much time I have left, but I'll finish with this one. I found the gist of what you said fairly alarming, somewhat worrisome. I'm not sure whether you folks, from the beginning of the process, were alarmed in any way through it.

We want a moratorium, but only on GMO fish. Shouldn't we have a moratorium on everything until we put all these other processes in place? You've suggested a moratorium on GMO fish, for the approval of GMO fish, but not on everything else that's coming down the pipe. What am I to assume from that?

Prof. Brian Ellis: Go ahead, Conrad.

Prof. Conrad Brunk: One of the reasons for the singling out of the fish was because the current science already identifies far more in the way of unanticipated pleiotropic and other effects in the fish, and the interactions, the impacts of those unanticipated changes on the surrounding ecology of fish, are far more evident now than these effects are on the plant side.

On the plant side, I think it would be fair to say—my colleagues can correct me here—it has not been as evident, though we're calling for more research on that. But because it was so evident on the fish side and because of the freedom of the ecological interactions—fish are mobile, plants are not—we felt there was sufficient basis for that call.

Prof. Brian Ellis: I was just going to reinforce that point. Escape of fish from net pens at fish farms is a routine occurrence. Once they're gone, there is no way of calling them back. As a matter of fact, they roam for thousands of kilometres.

It was a concern of the panel that our fisheries research is really undeveloped relative to our crop research. We do not understand the biology of fish in many ways, and it would be premature to be sending genetically modified versions of fish out into the ecosystem before we have a far better understanding of those interactions.

Prof. Marc Fortin: To address the question of whether we were alarmed or not, the report was focused on future developments in transgenic technology. We believe what we have currently on the market in terms of transgenic plants represents fairly simple genetic modifications. Technology can produce more sophisticated modifications in the future. Because of the uncertainty as to the potential effects and because of the lack of knowledge as to the effects of more sophisticated genetic manipulations—and we are not saying there are negative or deleterious effects—we need to be cautious.

• 1015

Perhaps, as Dr. Brunk has mentioned, five years from now we'll say “Fine, we haven't detected any major deleterious or unforeseen effects”, and then we can relax the regulations.

Mr. Gar Knutson: I find it alarming that we're not doing any independent university research. I'm not suggesting that something's going to blow up somewhere, but I'm just finding what you've outlined alarming.

The Chair: No matter how much you insist that you study the future, you cannot study the future unless you analyse the present and the lessons from the past. So we are entering here a very interesting dimension.

Thank you very much.

Mr. Reed, please.

Mr. Julian Reed (Halton, Lib.): Thank you, Mr. Chairman.

I take it that transgenics is the major biotechnology concern that you've zeroed in on. We've been engaged in biotechnology for over a century in one form or another. Are there other biotech concerns as well?

I'll give you one example. Forty years ago we were using metabolic modifiers in livestock feed, or in livestock generally. Some of them we found to be unacceptable in the long haul, and some passed unnoticed through the system. Are those parts of the biotechnology study that are of concern along with transgenics?

Prof. Brian Ellis: I think it's fair to say that the focus of the panel was almost exclusively on genetically engineered organisms. That is where most of the controversy and most of the uncertainty lies. But you're quite right, we have been manipulating many aspects of our food production system for decades, sometimes for centuries. Some of that has turned out very well. Much of it has turned out very well, apparently, but we've had some problems, too, some non-biotech problems.

Mr. Julian Reed: You're talking to a real neophyte here. Are there are any transgenic occurrences in nature?

Prof. Brian Ellis: I'm glad you asked that. The discovery that actually opened up the possibility of genetically engineering crops was the discovery that the crown gall bacterium, which is a pathogen of plants, causes galls on plants like grape vines and raspberries. That's a relatively minor plant disease in most cases, but when the biology was explored, it was found that the agrobacterium was actually transferring genes permanently into the plant.

So any time you see a crown gall on a raspberry cane or a grape vine, you are looking at a genetically engineered plant. This has been genetically engineered by the bacterium for its own purposes, but it is a transgenic plant, yes.

Mr. Julian Reed: One other comment in the study mentions a recommendation for the discontinuance of antibiotic resistance markers. I wonder if you would mind explaining that. Having had some familiarity with the feed business years back, I know the wholesale use of antibiotics in livestock feed produced resistances that we didn't want and that ended up being rolled over into a very negative effect. I just wondered how this fits into that.

Prof. Marc Fortin: You're right that antibiotics are used, sometimes massively, in animal production. Perhaps the antibiotic resistance genes that have been incorporated into transgenic plants do not represent much of a health threat. It is possible that this doesn't represent much of a health threat.

• 1020

There are, however, technologies that can replace antibiotic markers for generating GM, or genetically modified, plants. We're saying that given that there are alternative technologies, given that there is some uncertainty as to the potential health effects of antibiotic resistance genes in plants, we might as well discontinue using them and use alternative technologies.

Mr. Julian Reed: Thank you, Mr. Chairman.

The Chair: Thank you, Mr. Reed.

Madam Redman, Monsieur Charbonneau, Mr. Laliberte, and the chair.

Mrs. Karen Redman (Kitchener Centre, Lib.): Thank you, Mr. Chairman, and thank you all for coming today.

Dr. Brunk, it's especially nice to see somebody from my hometown. It's nice to see that we're sharing expertise here.

One of the issues that's been skirted around by a lot of members...and certainly Greenpeace Canada came out and said your report was actually an indictment against the current system. Does the panel believe the current regulatory process poses unacceptable risk to Canada?

Prof. Conrad Brunk: It would not be fair to conclude that on the basis of our report, because we did not look in depth at the protocols and the testing and at risk assessments that have been done for the current crops on the market.

Our process is an open process. By the terms of the Royal Society expert panel process, we have to make public everything in our report and anything we used for the basis of our decision-making. That meant the confidential information that's part of the assessments done by the regulatory agencies could not be given to us, because we could not guarantee confidentiality. Therefore, we did not have all of the information we would have to have had in order to know for certain what level of testing has been done on the products currently on the market.

We had conversations with people representing this. We've looked at all of their publicly published criteria for their requirements, which they give to the companies, and we made recommendations on how we felt those needed to be strengthened. But you could not conclude, on the basis of our report, that we researched the assessments done for the current products and are saying with confidence that we know they were not tested to the level the public should be worried about. We didn't interpret that as our mandate, but to look forward, as my colleagues have said, to the more complex technologies that are coming and to say “This is what is required.” But we didn't say that we feel they're safe, either.

Mrs. Karen Redman: Thank you.

Health department officials have also reported on the panel. They've characterized it such that you didn't understand the application of federal policies. Do you believe you had adequate access to the departmental documents in order to understand the current application of policies?

Prof. Conrad Brunk: That was a problem for us, for the reasons I just mentioned. One of the reasons was the confidentiality requirements for the agencies. Our publicity created a difficulty there. So we had to rely on what was publicly announced and publicly available, and that wasn't nearly everything.

Mrs. Karen Redman: Was it adequate, or can you even comment on the adequacy if you don't know what the body of information was that you didn't see?

Prof. Conrad Brunk: If our mandate had been to assess the adequacy of the current practice, then the information that we had would not have been adequate for reaching a conclusion.

Mrs. Karen Redman: Another topic, touched on here by my colleague, Mr. Comartin, I believe, has to do with the conflicts and the stresses that may be seen as part of the process, whether it's commercialization or good, pure science, and who's protecting Canadians. What were the specific conflicts of interest that were of concern to the panel? Were there any that were more prevalent than others?

• 1025

Prof. Conrad Brunk: One conflict of interest we identified very clearly is that among researchers themselves, including university researchers. This is a technology that has tremendous commercial value, and many of the researchers involved at the universities stand to benefit a great deal from being able to put their ideas into commercial production. So that tends to skew research in a certain direction, towards development. This is reinforced by the fact that increasingly our government research granting agencies are asking researchers to enter into partnerships with industry and others in order to get a research grant. This creates conflict of interest in respect of the agenda for research.

I wanted to make this point earlier, in response to some questions about whether university research is more independent than other kinds of research. In principle it is, but if we increasingly require the research at our universities to be done in partnership with those who have strong commercial interests in the development of the technology, and if there are decreasing amounts of government money to fund research solely dedicated to protecting the public interest and environmental interest, that's a serious conflict of interest problem, which the panel identified.

The Chair: Thank you.

Monsieur Charbonneau, followed by Mr. Laliberte, Mr. Lincoln, and the chair.

[Translation]

Mr. Yvon Charbonneau (Anjou—Rivière-des-Prairies, Lib.): Mr. Chairman, I have one final question.

Mr. Brunk has just described to us the possible limitations on objectivity in scientific research conducted in a university environment. Some situations may arise where conflicts of interests could occur.

Earlier, Professor Fortin told us that if the government promoted biotechnologies while at the same time funding research in this field, this might possibly compromise its objectivity.

How do we get around this problem? Obviously, we can't claim that businesses are the most objective given their commercial interests. If companies cannot be objective and if the government can't be objective because it occasionally promotes biotechnologies, and if universities are grappling with conflict of interest issues, what's the solution then to conducting research in a manner that is reassuring to the public?

[English]

Prof. Conrad Brunk: Fortunately, the agencies of government that provide research funding to universities are generally not the ones that are promoting or regulating a particular industry, like biotechnology. I think there is a high level of public confidence in independent research funding from government. In my opinion, the best way to fund independent research is through independent government provision. That funding is not coming from agencies of government that are necessarily promoting a technology.

It's a separate question, I think, whether the agencies that are regulating a technology are the same as those promoting the technology. That presents a problem. The more regulatory agencies can be independent of those agencies of government that promote the technology, the greater the public confidence in the regulatory process. I think we can cite examples of the problem from all over the world. For example, the Ministry of Agriculture and Fisheries in Britain got into serious problems over the BSE issue because it was so much perceived as being the promoter of the industry, and certain industry practices that came to be associated with the BSE crisis, that its own regulatory decisions and attempts to control the problem were not trusted.

[Translation]

Mr. Yvon Charbonneau: The solution, then, would be to maintain as much separation as possible between the regulatory bodies and the other parties.

• 1030

I have a question concerning the recommendations calling for the need for long-term research. The expert panel has alluded to this, and certain environmental groups have called for a long-term study of the effects of GMOs before they are approved.

Your recommendation is worded somewhat differently. You call for the following in recommendation 5.7:

... that a national research program be established to monitor the long-term effects of GM organisms on the environment, human health, and animal health and welfare.

Therefore, you're advocating long-term research following, not before, the marketing of a GM organism, if I understand you correctly. In any event, this seems like a more logical approach, because a long-term study prior to the process could take quite a long time. What kind of time frame are we talking about? Twenty years? Thirty years? Two generations? What about a follow-up study? Is this your response to those demanding long-term studies before GMOs are even marketed?

Prof. Marc Fortin: In fact, we're recommending two things. We're calling for long-term follow-up studies after GMOs are marketed. We are also recommending more in-depth studies prior to marketing and certification to establish, relying on the best possible scientific expertise, the absence of harmful effects. We will never establish zero risk. In biology, this has never happened. However, we must set the bar at an acceptable level, from a scientific standpoint. Therefore, we are calling for more in- depth studies, both prior to product approval and after marketing.

These studies will have to be conducted in an intelligent manner, based on the genetic data that the regulating body possesses. Given the information that will become available internationally, I feel it will be easier to minimize scientific uncertainty.

Mr. Yvon Charbonneau: I have one last question, Mr. Chairman. I believe my colleague Redman has already raised the matter, but I would like to focus on it again. I'm referring to relations between your expert panel and Health Canada.

I'm also Parliamentary Secretary to the Minister of Health, who has mentioned the quality of the panel's work and his interest in implementing your recommendations. However, certain Health Canada officials have cautioned that the panel may not have grasped fully the issue at stake, at least in so far as Health Canada is concerned.

Earlier, I thought I heard Professor Brunk say that you were restricted to public consultations. Does this mean that you did not have any private meetings with Health Canada officials, that you did not have the luxury of reviewing their procedures, theories and files or that this opportunity was denied you? What happened exactly?

As elected representatives, we have a duty to respond to questions from members of the public and from the opposition. Often, people take advantage of the discord between groups to allege that some facts have not been disclosed and so forth. Were certain facts kept from you? What happened exactly? Did you make any attempts to pursue the matter further after submitting your report? Have you had additional meetings to clarify matters? I'd appreciate your clearing up any confusion.

Prof. Marc Fortin: We met initially in March or April of 2000, when the expert panel first began its work, and at the time, we asked government agencies to send us all of the documentation they had about their procedures and processes and about existing regulatory provisions. We received a substantial number of documents which we reviewed. We subsequently requested some clarifications, which were provided to us.

• 1035

Then, in August 2000, we interviewed four representatives of regulatory agencies. We asked them questions and obtained answers with a view to getting a clearer picture of existing procedures and regulatory provisions. They cooperated with us. Staff from these regulatory agencies responded to each of our requests. However, we only obtained public documents, given that we were not in a position to guarantee the confidentiality of any documents turned over to us.

Mr. Yvon Charbonneau: Since the release of your report, have there been any further meetings in light of certain officials' comments? Have you had the chance to meet with them and to obtain additional information? They claim that you may not be fully apprised of the situation. That's normal, if they did not share certain information with you. However, if they did... Have you broached the subject again with them?

[English]

Prof. Conrad Brunk: We have made arrangements to meet with officials from Health Canada and the Canadian Food Inspection Agency. They have been in conversation with us. They have said they want to talk to us about implementation of the recommendations of the report.

I have also had opportunity to talk informally with some of the people at Health Canada about this question of whether we looked at all the documentation we should have asked for, and as we reflect on the process, it's clear that there probably were some misunderstandings between us about what information we were asking for. In our meeting we did ask for some additional information, which we didn't get, and in talking with officials, I suspect that was a misunderstanding. I don't think any of us feel it was a deliberate withholding of information. But there were some pieces of information that we didn't get that we thought we had asked for.

[Translation]

Mr. Yvon Charbonneau: Have you received them now?

[English]

Prof. Conrad Brunk: No.

The Chair: Thank you.

[Translation]

Thank you, Mr. Charbonneau.

[English]

We have Mr. Laliberte, Mr. Lincoln, the chair, and then a growing number for a second round, which makes me conclude that we may need to have another meeting on Thursday morning, if witnesses are available.

Mr. Laliberte, please.

Mr. Rick Laliberte (Churchill River, Lib.): Good morning, gentlemen.

I want to touch on a couple of recommendations and maybe the lack of a recommendation on one item.

The first recommendation I'd like to focus on is peer review. You highlight it as a major area. But also, in witnessing your panel members, it's not necessarily peer panels that are created here to make this report at this level. Should there be more of a balance, a cross-section of disciplines to be called upon for review as opposed to peers who are maybe just geneticists or just food specialists? Is there a call for more scientific peers, but a cross-section of disciplines, to look at this?

Prof. Brian Ellis: Can I get some clarification as to exactly which level of review you are thinking of? Are you talking about the review of regulatory decisions where, for instance, we have asked for the development of an independent panel that would look at those decisions? Is that the level of review you are considering?

Mr. Rick Laliberte: I was only looking at your recommendation, when you highlighted that one of the topics was “needs research in peer review”. Your overwhelming response is that we don't have all the answers, so we need research to address these, and one of the subtopics was peer review. I think a lot of the questions that arise from consumer or producer issues concern whether we should have not only peers in that specialty area, but cross-sections of disciplines that will review the process of genetically modified products.

• 1040

Prof. Brian Ellis: I think you're probably looking at recommendation 9(3) there, that the agencies implement a system of regular peer review of the risk assessments on which the approvals have been based, and that this should be conducted by an external, non-governmental, and independent panel of experts. You're asking whether that panel should be broader than simply molecular biologists and geneticists.

I can only give a personal opinion on that. I think yes, there needs to be a broadly based panel that includes geneticists and molecular biologists and ecologists. But there are issues, with respect to impacts, for instance, that have non-scientific dimensions, and there needs to be some representation of that in the review process.

Mr. Rick Laliberte: Labelling doesn't pop out in your list of major recommendations. The whole issue of mandatory and voluntary, of course, is the debate of the day. The other thing is that GMOs are the new kids on the block, and the burden of proof seems to be falling on organic farmers, organic producers, out there. They have to prove themselves that they are not handling GMO, and that kind of ruins the trade, the competitive aspect of it. I think that's a concern of the producer and consumer, if labelling comes into place. This whole labelling issue is a contentious one nationally and internationally.

Prof. Brian Ellis: A number of things are linked here. Ultimately, labelling is probably only going to be possible with a complete audit trail from producer to processor to retailer. Otherwise it's difficult to imagine how a meaningful label could be applied to the final product, outside of fresh fruits and vegetables—those are easy to label. If that has to be implemented, it will certainly increase the cost of food to some degree.

The organic farmer issue is a real challenge, because they have declared that “organic” does not include a genetically modified material. And given the promiscuity with which some crops will cross-pollinate, and then pollen will move, canola being a classic example, it's difficult to see how you can have an organic production operation anywhere in the vicinity of a grower who's using GM crops. It's not obvious to the panel how that's going to be resolved. It's going to be a real challenge.

Mr. Rick Laliberte: Along with that whole issue, somebody raised the international question, but there was no identification of international regulatory authorities on this. Is there a move at UNEP or any recognition of an authority out there? Because there are ethical questions, trade impacts that are affecting us, and I think we have to be linked at the international level. I think it's got to be simultaneous—you can't just deal with the domestic, national issues, and then wait and see where we fit internationally. It's a simultaneous effort, international, local, regional.

Prof. Brian Ellis: Well, you're right. No country in an atmosphere of free trade can decide these things alone, so that the very important decisions are going to be made at the level of the international organizations that try to set the standards on which free trade will be based. These include, of course, Codex, FAO, and WHO, and these are the standards then used by WTO in settling trade disputes.

There's a lot of work being done in this area, and the reports being produced by national governments and independent bodies in the different nations are being looked at very carefully. I'm sure the Royal Society report will be very carefully studied. In fact, I was at a WHO meeting just last week in Geneva at which this report and other reports were being looked at very carefully by the people who will be setting these kinds of international standards.

• 1045

Mr. Rick Laliberte: Thank you, Mr. Chair.

The Chair: Mr. Lincoln, please.

Mr. Clifford Lincoln (Lac-Saint-Louis, Lib.): I was reading some of your recommendations, and it was amazing how much the same issues surface again, the issues we were dealing with here when we were talking about pesticides. I refer to the review of pesticides in the report here. It seems as if these issues are almost generic to all these controversial questions, whether they concern biotechnology or chemicals versus regulation, safety, and human health. The same issues seem to pervade.

One issue is confidential business information, which restricts an open and transparent system. Another is the whole question of the precautionary principle: should we adopt it, modify it, restrict it, or not have it at all? We also have the conflict of interest arising from promotion vis-à-vis regulation, which we find in fact between some of the ministries themselves. One ministry promotes the producer, while another one tries to protect human health or the environment.

The whole question of the burden of proof and the reverse onus of proof seems to come up all the time, as well as the moral impetus for an ecological risk assessment beforehand or a reassessment when better knowledge is available. And then there's the whole question of peer review.

I would like to talk about your recommendations 8.2 and 8.3. In 8.1 you reject “substantial equivalence”, and you favour a system where we put the onus of proof on the producer. But then you say that the present laws and regulations actually do impose on the producer the onus of proving that the products are safe for human health and the environment. But then when we look at 8.3, we know there's no way a product can be guaranteed safe because experience shows that we only find out afterwards that problems arise.

Then you suggest that there should be an immediate reassessment, and you have cited the British experience, where as a result of a very tenuous feeling of precaution they in fact stopped the process. This brings us back to what you were talking about, the WHO and the WTO, where it seems again that there is a question of conflict of interest. The WHO obviously promotes human health, the WTO trade. I have read a paper recently where the WTO says it is looking at the precautionary principle and the reverse onus of proof as impediments to trade and that they would be declared ultra vires in regard to trade.

So how do we reconcile all these things? Shouldn't governments say that the precautionary principle, the onus of proof on the producer, and a transparent system of review assessment and regulation should be paramount, regardless of what ministry implements it? Shouldn't this be the priority of any government, regardless of trade or any other issues? In other words, shouldn't we put the environment and human health as paramount? Do I read that this is a sense of your report?

Prof. Conrad Brunk: Yes. We start with recognizing that the sum version of the precautionary principle has already been endorsed at the international level, especially in the Cartegena Protocol and the Montreal agreement and in most of the announced policies of the national governments that are partners in the free trade regime. They don't all agree on what the precautionary principle means, and you've identified the critical elements of that.

The chapter in our report on the precautionary principle tries to lay out each one of those issues you've raised in a very careful way—what it means to assign burden of proof; how you handle the fact that proving that something is safe is not possible scientifically—and that is not what the precautionary principle need require at all. We understand the precautionary principle to be basically a set of guidelines for handling uncertainties in the science, and we lay out what we think those guidelines for handling uncertainties in the science should be.

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Also, it has to do with assignment of the burden of proof. It also has to do with the standards of proof, which have to be relaxed if the burden of proof is assigned or if the evidence of safety is. So it is a very complex issue.

One of the interesting things we did not mention is part of the procedures of the expert panel process of the Royal Society of Canada. All of the reports are themselves subjected to a scientific peer review process. Our report was sent out to a group of anonymous peer reviewers, as would be the case to meet any standard for scientific publication. One of the interesting things that came back from several of the peer reviewers was that the chapter on the precautionary principle was one of the best treatments of this issue that they had seen, and they in fact encouraged independent publication of that chapter. So I think we on the panel do feel it's a significant contribution, and we hope people do read it carefully.

Mr. Clifford Lincoln: If I may, Mr. Chairman, on this same basis, how do we get comfort in the fact that...? We have had officials from some of our ministries here who were playing games with words, refusing to accept that the words “precautionary principle” should be inserted in any treaties or conventions internationally, let alone our legislation. We are fighting to have it in even health legislation sometimes. Somehow, the words have become a sort of plague on our houses. We don't mention them, or we mention them in some other way, so that by mentioning them in different ways, we can interpret them according to what the wishes of the powers that be or the WTO become.

Now that we have established this in Rio, now that your report has come out, now that the WHO, which promotes human health.... Is there any way we can have some sort of national and international thrust for looking at issues of precautionary principle, onus of proof, and a much broader definition of confidential business information that will be acceptable to the WTO? Isn't that what we should all be working toward? Whatever we say here, if the WTO rejects it, it seems as if it has become the paramount organization worldwide that rules over the WHO and all the various environmental organizations and treaties. It rules the day. So shouldn't the thrust be to try to get this accepted as basic principles of almost environmental and human rights and health rights?

Prof. Conrad Brunk: You're asking a very broad policy question about the international regulatory system that I think is beyond the expertise of this particular panel. Personally, however, I can say that I do spend some time working with these international agencies, and my impression is that the precautionary principle is becoming recognized as an important principle, although it is not agreed upon on how to interpret it. I can only say our report identified it as a legitimate and an important approach to the regulation of biotechnology, and it also tries to lay out an interpretation of it that we think would be workable in this international regulatory context.

The Chair: Thank you.

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In the February 6 issue of the Chronicle-Herald, Dennis Bueckert of the Canadian Press reported that, and I quote, “Bureaucrats say scientists didn't understand policies.” Would you like to comment?

Prof. Brian Ellis: That may have been the comment directed at our interpretation of the substantial equivalence principle and how it was perhaps being invoked within the Canadian regulatory system. I think there was considerable sensitivity around that.

We didn't claim they were using it inappropriately, but we did feel there was sufficient ambiguity around the way in which the principle was being embedded in the regulatory process and the way it appeared to be implemented when we talked to their staff. It definitely needed clarification, and we therefore came down on what I think is a very clear statement about how substantial equivalence could be appropriately used. But there definitely was some sensitivity around that.

The Chair: And how do you explain that degree of sensitivity?

Prof. Brian Ellis: Well, without interpreting for them, I think they feel they use it in an appropriate fashion—perhaps in the way we are recommending that it be used—and they feel they are not guilty of deploying it in perhaps a little more free and easy fashion, if I might put it that way.

Conrad.

Prof. Conrad Brunk: I would point out that those are not the only comments that have been made by agency officials and that many people who have read the report would not have that same response.

I think the fact is that our sponsors have asked to sit down with us and discuss these things. Having read the report now and having had time to reflect upon it, they have told us there are many things they feel can be very helpful. They want to enter into a positive consultative process, and I think the sober assessment of the report is really the thing that should be listened to in the end.

The Chair: In your presentation this morning you spent some time telling us about what your mandate did not include. What prompted you to invest time in telling us what your mandate did not include? What was the reason for doing that?

Prof. Conrad Brunk: Good question.

The panel has been criticized very severely on some sides for not having taken into account the benefits and for therefore having given a very skewed view of the situation with respect to biotechnology. Part of setting the context for what our report says and what it doesn't say is to clarify what our mandate was.

The Chair: And where does the criticism come from?

Prof. Conrad Brunk: I've seen a lot of it in the newspaper.

The Chair: Yes, but the newspapers themselves were not being critical. Where is the criticism coming from?

Prof. Conrad Brunk: I suppose those who feel it is important to emphasize the benefits of the technology and who felt this report did not do so gave a jaundiced view.

The Chair: Would it be correct, then, to conclude that the criticism came from scientists in the private sector?

Prof. Conrad Brunk: I've seen very little criticism from scientists. I have seen criticism from people who claim to be representing the industry or speaking on behalf of it. Whether they do or not, I don't know.

The Chair: Chapter 9, which is definitely a very important chapter—not to reduce the importance of others—raises serious concerns, and I'm reading now from the text, about:

...the undermining of the scientific basis for risk regulation in Canada due to the following factors:

- the conflict of interest created by giving to regulatory agencies the mandates both to promote the development of agricultural biotechnologies and to regulate it;

- the barriers of confidentiality that compromise the transparency and openness to scientific peer review of the science upon which regulatory decisions are based; and

- the extensive and growing conflicts of interest within the scientific community due to entrepreneurial interests in resulting technologies....

Do you stand by those three statements?

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Prof. Conrad Brunk: Yes, all members of the panel stand by those statements in the report.

The Chair: Thank you.

Your chapter 9 ends with the following paragraph:

This co-opting of biotechnology science by commercial interest contributes to the general erosion of public confidence in the objectivity and independence of the science behind the regulation of food biotechnology. It reduces significantly the scientific resources available to government regulators of the technology and, hence, the reliability of the science base of this regulation. This situation is one that goes well beyond the power of government regulatory agencies to remedy on their own. Instead, they suffer the consequences of these dynamics in the society insofar as the knowledge base they depend upon for the evaluation of technological risks is impoverished. The Expert Panel considers this to be a serious public policy issue related to the public funding of independent scientific research in the universities, and can be remedied only by those in government who formulate and implement these public policies.

You stand by this statement as well.

Prof. Conrad Brunk: Yes.

The Chair: If you put together the main recommendations in chapter 9, and also chapter 5 and others, what would be your proposal in order to ensure that biotechnology products are brought to market in a safe manner?

Prof. Conrad Brunk: Our concern here is the fact that our government regulatory agencies, as do most government regulatory agencies, do not have the resources to do the testing of these products themselves. They depend upon the testing that is carried out by those who submit these products for registration. They do not have the scientific capacity to evaluate these assessments if there is not a sufficient set of data and a science base out there that the regulators can draw upon.

We saw this comment as being very much in support of our regulatory agencies, calling upon other agencies of government who provide funding for research, independent research in the universities, to provide the kind of science base that is out there that our regulators need in order to carry out their side of this regulatory process—to the extent that this science base is impoverished and the job of the regulators is much more difficult.

My colleagues might want to comment further on that.

The Chair: But there is, in addition to science impoverishment, the fact that you fear in the future that there may be a conflict of interest of the Canadian Food Inspection Agency within its mandate.

Prof. Conrad Brunk: Yes, that's a separate issue from this science-based issue.

The Chair: Yes, but nevertheless it's part of the overall package that needs to be put together.

Prof. Conrad Brunk: Yes.

The Chair: That implies then that if you're fearful about the future of this inspection agency, you have reason to believe that in the present time there is a conflict of interest within the agency that needs to be dealt with.

Prof. Brian Ellis: I think it's fair to say the agency was born out of a conflict of interest because of course it arose from Agriculture and Agri-Food Canada, which had a very strong biotechnology development program and at the same time was supposed to be monitoring the deployment of the technology. To address that conflict of interest, the CFIA was spun off and given a separate mandate. It doesn't do the development of biotechnology, but it still has carried with it some promotional mandate, as witnessed by some of the literature it distributes and the way in which it treats biotechnology.

The Chair: So would it be correct to conclude that in order to ensure a safe future, the role of this agency needs to be examined and possibly modified?

Prof. Marc Fortin: We have indicated we were concerned with some of the stances that were taken by officials of the CFIA, the Canadian Food Inspection Agency. There is a strong need for exercising the utmost neutrality in the debate and to be perceived as neutral. That was a source of concern to the expert panel.

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The Chair: Therefore, since there is a need for neutrality, that would imply at the present time this neutrality is not readily identified, or there are some difficulties.

Prof. Conrad Brunk: I would interpret what Dr. Fortin is calling neutrality.... The agency said to us very clearly, and we say this in the report, that they feel the need to maintain certain relationships—collegial relationships—with the industry they regulate because this does require a certain amount of cooperation and collegiality.

I think you're referring to neutrality in that sense, perhaps. When you're in the position where you're having to represent both sides of the equation, then you erode public confidence in your objectivity when it comes to the regulation of the technology.

The Chair: Would you say that, of the scientific community that is competent in this field of genetic engineering at the present time in Canada, a small minority, 50%, or a large majority is working for industry? What would be your assessment of the three, or more, possibilities? Would you say that a small number, or half of your sector, or the vast majority?

Prof. Marc Fortin: I think we are facing similar challenges in the pharmaceutical industry. Pharmaceutical companies develop products, and then these products are tested in the scientific community, fairly often by the university research community. There are ways to protect the objectivity or integrity of the university research.

At the moment, I think we're seeing a minority of research scientists in the university community who are associated with the biotech industry.

Even if it was 50-50, there are ways to protect this integrity. The pharmaceutical industry has done that fairly well over the last 30, 40, 50 years.

The Chair: What is the difference in salary between a scientific person attached to a university, not working for industry, and one working for industry?

Prof. Brian Ellis: Industry researchers are typically paid more, sometimes quite substantially more, but of course they don't have the security that academic researchers have. So there's a trade-off.

Prof. Marc Fortin: I'd like to clarify. I'm not sure if your question was asking whether university researchers who engage in research with industry are paid any differently. Was that the—

The Chair: No, no. Just a total taxable income, comparing the two activities.

Prof. Marc Fortin: In the private sector, we're looking at probably a 1.5, or 2, or 2.5 full difference in salary.

The Chair: But you would say, you conclude, that not even half of the scientists competent in genetic engineering are presently hired by industry.

Prof. Brian Ellis: No.

The Chair: It's a small group.

Prof. Brian Ellis: Certainly in Canada, it's a small proportion.

The Chair: And in the case of the food agency—the one we were talking about earlier—would they have a scientific capacity? If so, is it adequate?

Prof. Brian Ellis: I personally don't know exactly how large their staff is or what the level of training is. We only met a small number of them.

Prof. Marc Fortin: We have not reviewed their personnel in order to assess their expertise. We've only met with a few individuals.

The Chair: I would like to ask you a question related to Mr. Laliberte's question earlier. If Canada were to sign the Convention on Biological Diversity, would that be an advantage in keeping abreast with the international community? Would that have positive repercussions? Is it a desirable thing for that to be done, and if so, soon?

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Prof. Conrad Brunk: The panel didn't discuss that issue, and so I think any answer we give, we would be giving individually, reflecting our own views of that.

The Chair: And what would be your personal answer?

Prof. Conrad Brunk: My personal answer is that it would be an advance.

The Chair: We have had a tremendous morning and a terrific experience. We have probably only scratched the surface. We need to learn more. We're very grateful to you for the time you've given us. We'll try to arrange a second meeting and invite the members of the health committee to join us, and possibly also members of the agricultural committee, so that your findings are shared with a larger number of elected representatives.

In the meantime, we thank you very much for your good work, for your findings, which in my view—and I'm speaking only for myself—are of tremendous consequence. We hope to see you again.

Prof. Brian Ellis: Thank you very much, Mr. Chair.

The Chair: This meeting is adjourned.