EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, June 4, 1996

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[English]

The Chairman: Order.

We are slightly delayed because of a meeting that started at eight o'clock in this room. We hope that the delay will allow people to organize their thoughts and to have a good start.

As you know, in this committee we are interested in the subject of biotechnology and are very glad to see so many witnesses and observers.

I would like to draw to the attention of the members of the committee the paper entitled, ``Biotechnology Study'', by Tom Curran, our researcher. It is dated May 29 and it was delivered yesterday to our respective offices. I suggest that you make as much use of that paper as you wish, because I think it will permit us to explore the issues better and in greater depth.

Without any further delay, since we have so many groups this morning, I would, as is suggested by our witnesses, invite Mr. Rick Walter, the executive director of the Canadian Institute of Biotechnology, to introduce his group and then start his presentation, keeping in mind that the shorter the presentations are, the longer will be the question period for mutual advantage.

Mr. Walter, welcome. I am glad to see you with us this morning, as well as your colleagues.

Mr. Rick Walter (Executive Director, Canadian Institute of Biotechnology): Thank you very much, Mr. Chair. Good morning, ladies and gentlemen.

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We would like to thank you for the opportunity to speak with you today. In fact, three biotechnology organizations will be presenting to you, and I believe you'll find a range of views from the organizations.

I propose to open with the first presentation. I will be followed by Graham Strachan, who is the chairman of the National Biotechnology Advisory Committee. The final presentation will be made by Dr. Jack Wearing, who is the chairman of the Industrial Biotechnology Association of Canada. He has with him also two industrial representatives from companies. Jack can probably introduce both of them later.

We'd be pleased to answer any questions you have after the presentations, if that arrangement is acceptable to you, Mr. Chair.

The Canadian Institute of Biotechnology is a not-for-profit umbrella organization which represents industrial and professional organizations, regional and sectoral groups, research centres, and universities involved in biotechnology. We support activities related to technology transfer, to human resource development, networking, communications, and public awareness across our nation.

Canada has evolved slowly to develop and regulate biotechnology. In fact, since the Minister of Science first recognized it as a strategic technology in 1977, nineteen years have passed as the infrastructure and the process have been developed and finally the commercialization of a new wave of products has become a reality. Over this period an entire community has evolved, including not only the government and industry but also the university sector, the business services sector, and consumer and environmental groups. I would like to spend a few minutes to illustrate the intricacy and depth of this community.

Government has four different roles, including regulation, research, technology transfer, and communication. Government has been successful in providing an environment for the advancement of this technology while maintaining high standards for human health, environmental protection, and animal safety. The regulatory system has been acknowledged by many, including many OECD member countries, as one of the best in the world, although as in any system there is room for improvement.

The community is already attempting to address areas that require improvement. I have left with you a brief description of a project entitled the Microcosm Validation Project as an example of a cooperative approach to problem resolution. This project is focused on risk assessment methodology.

The industry is rapidly growing and diversifying into virtually all traditional industrial sectors. This extends far beyond the multinational corporations to embrace a number of successful medium-sized firms and a large number of small companies. It represents not only the users of biotechnology but the suppliers to the industry, including financial, management consulting, and legal services, as well as a wide variety of equipment and material suppliers. As presented to you earlier by Dr. Deacon of Industry Canada, the industry currently consists of approximately500 firms, with gross sales on the order of $4 billion a year. We also estimate that employment is nearing 20,000. As well the industry has continued to expand, even through the recent recession, at annual levels of over 15%.

All of this is to say Canada has invested a tremendous amount in pursuing the application of this technology, and only now are the financial benefits beginning to accrue. Many companies have their stock at all-time highs. One Canadian biotechnology firm, located in Montreal, has recently completed the world's largest secondary biotechnology share offering. That was Biochem Pharma, recently done at $252 million.

On to our university community, which is extensive and has a long-standing reputation for undertaking world-class research. Scientists from all over the world come to Canada to benefit from our own high-calibre scientists, our broad-based expertise, and our state-of-the-art infrastructure. Virtually all the universities in Canada support either training or research in biotechnology. These assets combine to allow Canada to boast a high level of scientific expertise, which has become important not only for industrial innovation but also for the regulation of biotechnology by providing scientific tools to assess and monitor new products.

Environmental and consumer organizations as well as the farming community, dietitians, and health care professionals are becoming increasingly interested in the science as well as the applications of biotechnology. These diverse groups represent an equally diverse range of opinions on the issues surrounding the technology. They are becoming more informed so they in turn can provide better information to their constituents.

A small number of these groups are skeptical about the benefits of biotechnology as well as other innovative technologies, and they have been very vocal in their opposition. However, it is clear many are supportive of the potential benefits of biotechnology, recognizing that any products using biotechnology must be safe.

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The perspectives from the various interests reflect a broad range of members within our community, from those who do not want any new technology - biotechnology of course being only one of the many - to those who are completely accepting of the application of science to increasing their standard of living. Most interests lie somewhere in the middle.

In the case of food, opinion surveys have identified consumers' main concerns as nutrition, price and quality. Many of these consumers are open to new products if they fulfil these three requirements. Food biotechnology is seen by some as a way to meet these needs. A vocal minority has been opposed to food biotechnology, but the diversity of other opinions, including those who want new alternatives, is also relevant.

Whose opinion should carry greater weight, or is there a way to respect all needs? I suspect that part of the answer lies in consumer information. The supply of information to consumers is a very complex issue, beyond my ability to deal with properly this morning. However, I understand that this area will be dealt with tomorrow in greater detail by several organizations with whom the CIB has had long involvement. These include the Consumer Association of Canada, Fédération nationale des associations de consommateurs in Quebec, the Food Biotechnology Centre, Agriculture and Agri-Food Canada, and Health Canada.

Canada has achieved a strong international reputation for its cautious, pragmatic approach to dealing with biotechnology, from its science to its regulation. We are seen as one of the world leaders. If we were now to change our approach to regulation and research in any fundamental way, our decisions would have far-reaching impact with many countries, including our trading partners.

One specific example is the European Union's increasing dissatisfaction with its process-based approach and the realization that the product-commodity approach taken in Canada offers more flexibility and is simply more reasonable. One cannot assess the risk of very different organisms and/or products based on the technology used to derive them.

As well, Canadian legislation is being used as a template or standard for many developing countries. For example, the CIB is currently working with Mexico, Cuba, Argentina and Columbia to support their regulatory and policy development as well as to identify ways in which Canada can provide biotechnology solutions to problems defined by each of the countries. This program, called CamBioTec, is jointly managed by the CIB, the International Development Research Centre and several Latin American organizations.

In conclusion, a diverse community exists that is involved in research, applications, regulation and communications, and the different parties all have legitimate interests and points of view on how this technology is applied. This point unfortunately often gets lost in the melee of conspicuous voices, both detractors and supporters of the technologies.

The issues surrounding biotechnology are complex. The consequences of mismanaging the ongoing development in biotechnology are significant in terms of wealth generation for Canada, the supply of new and beneficial products for consumers, our international reputation and our competitiveness. Thank you very much.

The Chairman: Thank you, Mr. Walter. I'm very grateful for the fact that you tackled in your presentation the question of interests and how they break down to some extent. As you know, our committee is in pursuit of what is in the best interests of the public. That is the challenge before us. Any attempt to clarify what is in the best interests of the public will help this committee considerably.

Would Mr. Strachan like to start?

Mr. Graham Strachan (President, National Biotechnology Advisory Committee): I'd like to thank you for giving us the opportunity to participate in this process of reviewing CEPA. I'm appearing in my role as chair of the National Biotechnology Advisory Committee. This is a committee of volunteers. It's appointed by the Minister of Industry to advise the minister on strategies and approaches to create and maintain an internationally competitive biotechnology industry in this country.

In my real life, my day job, I'm president and CEO of Allelix Biopharmaceuticals. We have a company of about 200 people located in Mississauga and we're applying biotechnology to the development of innovative pharmaceutical products. I'd just like to mention that we added 40 staff in the last year, roughly a 20% increase. All of these are high-quality jobs with demanding graduate qualifications.

NBAC was established in 1983 as one of the pillars of the national biotechnology strategy. It currently has 19 members drawn from all regions of the country, and it's representative of the breadth of the biotechnology community, which Rick Walter has just alluded to. There are people like Dr. Kelvin Ogilvie, president of Acadia University; Michel Chrétien, of CRIM in Montreal; Madame Suzanne Hendricks from the National Institute of Nutrition; Ms Susan Smith, who is vice-president of knowledge banking for the Royal Bank, providing financial and investment perspective; and Hugh Wynne-Edwards from Vancouver, who is particularly knowledgeable about technology transfer issues and also communication.

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In advising the Minister of Industry, this committee has, quite naturally, tended to focus on approaches to accelerating the growth of commercial biotechnology in this country, recognizing the important effect this could have on the very important subject of job creation and creating economic wealth, particularly for our young students coming out of our universities.

In 1991 the committee issued a report that identified five ingredients key to creating a competitive environment for Canada in biotechnology. If I can just go through these, they were readily available risk capital; a well-trained and motivated human resource pool; strong and effective patent protection; a regulatory framework that is comprehensive, clear, and predictable; and finally, of course, public acceptance and support.

If I look back over the five years since that 1991 report, I'm pleased to say that we've made really great progress on many of these issues.

Certainly if you look at the very important aspect of risk capital, which historically has been in short supply for knowledge-based industries in Canada, I believe there's now adequate capital in this country to commercialize scientific discoveries coming out of our universities and medical schools.

There's been a sea change since 1991. Our banks, our investment houses, and labour-sponsored venture capital pools, like Working Ventures and the Canadian Medical Discoveries Fund, are now very knowledgeable and willing investors and sources of financing for this sector. Statistics recently published by Dr. Denys Cooper of the National Research Council indicate that the private sector has invested over $1 billion of equity capital in Canadian biotechnology since 1991.

What has been the result? It's been the creation of many new companies, some of them in clusters: biopharmaceutical companies in Montreal, a very diverse cluster of agriculture biotech companies in Saskatoon, natural resources and pharmaceuticals in British Columbia.

As Rick Walter noted in his presentation, there are approximately 500 firms with gross sales of $4 billion and with strong export volume. Core employment is estimated at around 20,000 people.

Some of these companies are quite large by any standard. Biochem Pharma, a company that Rick referred to in Montreal, now has over 1,000 employees, and it's first product, 3TC, which I'm sure many of you have heard about, for treating AIDS sufferers, has now moved into international markets.

As a country, we're now beginning to see the pay-off of the very significant investments - made both by government and by the private sector - in the late 1980s.

Coming back to the 1991 report of the NBAC, this identified regulations as being one of the key issues impacting on the economic growth of this technology and consistent with the need for high regulatory standards to protect human health and the environment, based of course on sound scientific principles.

The NBAC, in its discussion around regulations, suggested several areas for improvement, such as avoiding duplication by making clear who in fact had regulatory responsibility, improving the test protocols, making sure that there were adequate trained staff in the line departments to deal with the increasing volume of applications, and shortening the overall time for approval.

The last point is particularly important, because in this business you have to keep in mind that the lead times from concept to the marketplace are very long indeed. Whether it's agriculture or pharmaceuticals doesn't really matter. It is between 10 and 12 years on $200 million to $300 million of invested capital. So clearly we need a predictable and certain regulatory system.

Over the last several years we have indeed made progress on the regulatory front. We have one of the most comprehensive sets of regulations and draft regulations for biotechnology of all our major trading partners, a regulatory framework that's respected worldwide. It's more stringent than that of the United States and more complete than that of the European Union.

With support from the provinces, the federal government has taken on a federal approach to try to ensure that there's no overlap or duplication in regulations.

Although not all of our regulations have gone to the Gazette yet, voluntary compliance by Canadian industry is over 100%.

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The proposed revisions to CEPA introduce a major element of uncertainty in the regulatory framework. There is a danger, if recommendations 68 and 69 are implemented, that departmental responsibilities for biotechnology will be blocked. In diluting the responsibilities of Health Canada and Agriculture and Agri-Food Canada, the government and industry would likely lose the large body of specialized expertise that has been built up, sometimes quite painfully, over decades of hard-won practical experience.

It seems to me the results will be duplication, increased costs for the users of the system, and a further stretch of the time lines for regulatory review, which, as the NBAC has noted repeatedly, are already too long and not internationally competitive.

You have to keep in mind that biotechnology is a pervasive enabling technology. Many countries are focusing on trying to catch the competitive advantage of this technology. We can't afford to fall behind if we're to remain in the race. If we were to make the mistake of overregulating Canadian goods and services, our products, such as vaccines, in which we have a large export business will likely become uncompetitive on the world markets. Some sectors of the Canadian industry will certainly be at a competitive disadvantage.

In conclusion, the NBAC's position is that the current federal regulatory framework provides a rigorous, safe, and reasonably predictable regulatory system for biotechnology products. We should focus on ways of improving the existing system, for example, by ensuring that the line departments have adequate, well-trained and knowledgeable staff, so biotechnology can continue to create economic growth and jobs within Canada, while providing consumers with safe and effective products, which are very much needed. In a very real sense, investment, jobs and growth in biotechnology depend upon a responsive and flexible regulatory system. Thank you very much.

The Chairman: Thank you, Mr. Strachan.

Dr. Wearing, would you like to go next?

Dr. Jack Wearing (Chairman, Industrial Biotechnology Association of Canada): Good morning. We are fortunate today to have broad representation from the Canadian biotechnology community.

CIB has strong federal-provincial links, since its members include associations from biopharmaceutical centres like Ontario, Quebec, and B.C., and agricultural provinces like Saskatchewan and the Maritimes.

Mr. Graham Strachan is president of Allelix, one of Canada's leading biopharmaceutical companies, which is creating new, high-quality jobs. Mrs. Margaret Gadsby is with AgrEvo in Saskatchewan, the firm that gained the first biotech canola approval. She can address your questions regarding plant agriculture. Dr. David Gannon of Zeneca is developing bioremediation products that properly fall under CEPA. He has been cooperating with Environment Canada since 1988 in developing CEPA biotechnology regulations addressing safety of the environment and the protection of human health.

The Industrial Biotechnology Association of Canada, or IBAC, is an organization that represents some 50 Canadian firms involved in biotechnology. IBAC focuses on the challenges facing biotechnology in matters of commercialization; regulation, including environmental and human health; public understanding; market acceptance; human resources; R and D policy; and strategic partnering.

Let us get straight to the point. Our major difficulty with the proposed CEPA relates to recommendations 68 and 69 in the report of the Standing Committee on Environment and Sustainable Development. Copies of both are in the handout. We also want to point out our concerns about the Canadian government's response to the standing committee in which it stated that: ``It is intended that CEPA would serve as the `safety net' for those areas that are not covered by other federal Acts''.

CEPA has worked well within the current regulatory framework. Responsibility for all products, including biotechnology ones, under various acts remains with those departments. Products, including biotech ones not covered by other acts, such as bioremediation products, lie with Environment Canada. For example, biopharmaceuticals such as recombinant insulin and vaccines are handled by Health Canada. Agriculture and Agri-Food Canada is internationally renowned for its expertise in agricultural regulation.

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Our concern is that the proposed safety net could lead directly to departmental overlap and could be used for purposes other than safety. We do not want it to become a potential spider web for both industry and government.

The revised CEPA should not encourage Environment Canada to prevail over line departments that are in the process of developing new regulations. Regarding CEPA concerns such as toxicity, line departments must be given adequate time to develop appropriate regulations.

These departments have a vast amount of experience in their specialized fields of expertise gained through decades of regulating the products of traditional biotechnology. They work with their counterparts worldwide on international harmonization efforts. This knowledge is of great value to Canada, as it provides experienced, efficient regulation. It has been accumulated through the combined efforts of regulators and researchers in government, universities and industry.

You have already heard from the departments about how they are working well together under a set of guiding principles announced in January 1993. You have already heard that this set of principles assesses safety and efficacy on the basis of risk and applies to all products, regardless of how they are developed.

According to Mr. Morrissey, from Agriculture and Agri-Food Canada, the existing regulatory structure as originally designed by Parliament is equally applicable to the new regulation of new products, whether derived through new or traditional biotechnology. That was from a presentation to the standing committee, May 16, 1996.

The provincial governments have also expressed support for the existing regulatory framework. Therefore, the Canadian government should rely on the existing and growing expertise within the line departments when considering all legislative and regulatory aspects of a product. Regulations developed under CEPA should not duplicate those that have been developed under other federal acts.

Let me state clearly that we are deeply concerned about the safety of Canadians and the safety of our environment. At IBAC we are taking a leadership position in ensuring that the biotechnology industry acts responsibly in developing good practices and addressing issues. That is why we have recently developed an ethics committee at IBAC. This follows the excellent example of the Treasury Board's voluntary codes project.

Let me conclude with the broader issue of sustainable development and new technology. Today's world population is about 5.7 billion, with 25% living in conditions of abject poverty. In30 years, the global population is expected to be 10 billion to 12 billion, with most of the growth in the world's poorest areas.

Through sustainable development we must deal with the awesome growth of population and the prospect of global environmental degradation if we use the technology of the past.

Some environmentalists advocate going back to the traditional technologies used when the world had 2 billion people. I would suggest that this is an elitist approach, open only to better-off people from developed countries able to build high walls and life support systems. Sustainable development will require new technologies, including biotechnology, to reduce environmental impact while steadily improving human health.

In summary, we believe that the current federal framework supports a stringent, well-defined, predictable, efficient and safe regulatory system for biotechnology products. Products should continue to be regulated under existing acts in their line departments.

A regulatory system has been developed in an open and consultative way that is fair to all citizens and recognized as a model internationally.

We would be pleased to answer your questions. Thank you.

The Chairman: Thank you. We would be glad to start the first round.

[Translation]

Would you like to start, Ms Guay?

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Ms Guay (Laurentides): Good morning, gentlemen.

I would like you to give me some information on an issue you did not dwell on. I'd like to know how Canada compares to other countries as far as biotechnic product development and applications are concerned. Are we competitive? Is Canada at the forefront? I would like you to elaborate on this.

[English]

Mr. Walter: I'd just like to verify whether your question included both developing and developed nations or whether there was a focus on developing nations?

[Translation]

Ms Guay: I had in mind developed countries such as the United States.

[English]

Mr. Walter: I suppose maybe I could give this a first crack at least. Canada certainly is among the world leaders in biotechnology. Obviously the United States has a significant lead in a number of areas, including health care, agriculture, the environment and some of the other developments. But Canada does have a world-renowned expertise. Some of its companies are internationally competitive, both in their technologies and in their products. We certainly do have the expertise to develop some of the best regulations in the world.

As I mentioned in my speech, there is a feeling around the world that Canada is among the leaders in the development of consistent biotechnology regulation. We are looked to by countries around the world, including Japan, the OECD, and in many cases even the leaders in the United States to determine what is a reasonable regulatory oversight mechanism.

[Translation]

Ms Guay: I have read in one of your documents that our regulations in Canada were too costly and that they were an international competitive disadvantage. I would like to know what the problems are with CEPA.

[English]

Mr. Walter: Again, I would like to clarify your question. You're asking for the areas where we consider there might be problems with our international competitiveness. Is this correct? Sorry, the clerk was speaking to me while you were asking your question.

[Translation]

Ms Guay: In one of your documents, you say that the Canadian regulatory framework under CEPA is too costly and constitutes an international competitive disadvantage. I don't have any specific area in mind because you didn't give any particular examples. I think that it affects all government departments. For example, you say that the approval process for agri-food products may be much more costly than for conventional products. The difference can be as high as $400,000. I would like to know why it is so.

[English]

Mr. Walter: I can't really speak to that specific question.

Would you like to touch on those? They came from a presentation of overheads, I believe, from the NBAC group.

Ms Margaret C. Gadsby (Director, Scientific and Regulatory Affairs, AgrEvo Canada Inc.): Certainly the answer to this question differs a little bit depending on the product of biotechnology, because different products obviously have different data requirements. But in general, compared to the United States, for instance, the regulations in Canada as they exist today require more data to be developed.

This means added investment dollars have to be put into research in Canada that would not be required just to commercialize a product in the United States. At the same time, the length of time this review process takes in Canada is longer than in the United States.

These kinds of things - the added cost and the added time to commercialization - are big problems for industry, and obviously in each case the details are somewhat different. But in general this is the problem from a competitiveness point of view.

[Translation]

Ms Guay: How come it takes longer in Canada? Is it because of the way the system works, because it is too slow? What improvements could we make so that we remain competitive while protecting the environment and public health?

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[English]

Mr. Strachan: I would like to suggest one way would be, through the system of user fees now in place, to improve the numbers of people dealing with the applications, to improve their qualifications or experience - their knowledge base - and to ensure there's very good communication between the various departments dealing with the specific products. This would be one way to expedite and shorten the process. At the end of the day this would reduce the overall cost.

[Translation]

Ms Guay: Does this mean that, right now, overlapping between various government departments is slowing the process down and that we should be addressing the problem?

[English]

Mr. Strachan: My own experience has been that over the years we haven't paid attention to appropriate levels of staffing and appropriate qualifications for staff. This is a more serious problem than overlap.

[Translation]

Ms Guay: Indeed.

The Chairman: Thank you, Ms Guay.

[English]

Mr. Forseth.

Mr. Forseth (New Westminster - Burnaby): Thank you very much, Mr. Chairman.

In the presentations we have heard today, there were references made to CEPA and the safety net it proposes in the committee's report. It talks about the safety net concept upon which the views of the public and stakeholders will be sought during the consultation process. This includes the notification and assessment process to determine whether a biotechnology product may have an immediate or long-term harmful effect on the environment, including impacts on biodiversity, or may constitute a danger to the environment on which human life depends, or may constitute a danger in Canada to human life or health. These products might also be used for environmental remediation such as cleaning up spills and so forth.

References were made to the fact that you folks are ethical. You have an ethics committee and you're very responsible. In a way I'm asking what the fear is. Is the present regime working? You're suggesting the recommendations of the safety net and the involvement of CEPA is not to be followed through, not to be recommended or advocated by you folks. So I'm asking directly, what are you saying, then? Do you want no oversight? Do you want just self-regulation? What is the essence of what you're proposing as an alternative? Certainly cost is not the only factor.

I want some general comments from a number of speakers. What is that bottom line? Is it health or is it money?

Dr. Wearing: Let me respond to this. First of all, what we are concerned about is departmental overlap. I would suggest this should be as much of a concern to government as it is to industry. For at least 10 years we have had a line department responsible for its products, and then Environment Canada works cooperatively with them to ensure it addresses issues of environmental and human safety. So you have a lead department working in cooperation with others, interdepartmentally and in other ways. And you see some changes in regulations to allow this line department to indeed cover that.

What we are concerned about is the publication of a set of regulations, a so-called safety net or template, where in effect you would then have a line department addressing the issue in cooperation with Environment Canada. At the same time you would have a set of regulations gazetted and covering exactly the same issue. From a public, industry and a government point of view, this means you then have an overlap between the two departments instead of a cooperative effort through the line department, whether it be environment, agriculture or health.

So we are definitely concerned about safety. What we're talking about is the way this is achieved. Shall we continue the process developed over the last 10 years, or shall we gazette something you call a safety net and lead to environmental and regulatory overlap?

Mr. Forseth: Can you give me an example? When you're referring to a line department, what would be the standard examples?

Dr. Wearing: We have acts covering different products. So for instance, biopharmaceuticals and human and animal fall under Health Canada. Health Canada works with the other departments to ensure that when it completes its assessment, the others believe it has been completely done, covering the interests of all the departments. But you in effect have a line cooperation model instead of ``We're both responsible for it'', and in effect you get a turf or an overlap concern.

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Mr. Forseth: You talked about a safety net becoming perverse and becoming a spider's web. The analogy there is that the spider's web catches something unawares and entangles it, so it becomes a negative. But the structures are somewhat the same in that there are many points, and if you pull on any one point, everything else is affected. That's often the way of the regulatory climate we are in. That's the world we are in.

It may be that we need some kind of overriding regulation to provide order in this very labyrinthine world we are in, lest we have all kinds of things falling through the cracks and lest the bottom line rather than health and the general public interest is looked after.

I would like to hear a little bit more about your general fear about the safety net becoming a spider's web.

Dr. Wearing: You've expressed it very well, and that is exactly the concern. In fact, I think the way you expressed it shows that the concern should really be one of government. The way we've regulated for the last ten years has allowed erythropoietin to come through the biopharmaceutical side, which has allowed several companies to bring forward canola.

Let's take oilseeds for a minute - sorry, Margaret. I said Margaret would look after plants, but I can't resist.

The major world oilseed is soybean. The second, and fastest-growing, is canola. So canola is Canada's oilseed. Because Agriculture and Agri-Food Canada have been able to work at an international competitive... we have developments in Canada's oilseed proceeding at the same time as soybean. That is a good example of the regulatory process working.

Our concern is whether we need to change the system, as the two previous speakers mentioned, or continue to build the system we have.

The Chairman: Mr. Walter wants to answer.

Mr. Walter: Just for clarification, I would like to point out that the entire biotechnology community, or virtually the entire community, is in general support of the concept of having the existing line departments, including Agriculture, Health Canada, Natural Resources Canada and Environment Canada, regulate the products that presently fall under their own acts. That includes CEPA.

So CEPA continues to be the general safety net to capture those products that fall between the cracks or outside the realm of each of the individual line departments. I think the concept here is not the elimination of CEPA as a safety net but in fact to use it just as that, rather than as an attempt to capture all of the products falling under the existing acts and line departments.

Ms Gadsby: One of the important parts we have to keep in mind here, as we work interdepartmentally, as we are cooperative, as we have different line departments being responsible for different products of biotechnology and regulating them in a manner that's equivalent to the traditional products, is that we want to have the authority and the responsibility residing in the same place.

Those line departments have the responsibility to monitor those products at this point in time, and we want to make sure they also have the authority. If CEPA is a safety net to catch those things that are outside the bounds of other pieces of legislation, that's fine, but we want to make sure it would not then become intertwined and cause a problem with authority inside those line departments.

Mr. Forseth: Thank you very much, Mr. Chairman.

The Chairman: Thank you, Mr. Forseth.

We now have Mr. Lincoln, followed by Mr. Adams and then Mr. Knutson.

Mr. Lincoln, please.

Mr. Lincoln (Lachine - Lac-Saint-Louis): I just have a brief remark.

Mr. Walter, I noticed when you addressed what the public concerns were, you mentioned nutrition, price and quality. Certainly if I think of people I know, to them health and environment would be key questions.

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Sometimes I think making haste slowly is something Canadians like, too. I think of BST, where the United States has forged ahead and we've taken a lot of time. I think the great majority of Canadians like us taking more time to be sure. That's my feeling, anyway. Certainly it's the feeling of a lot of people in our caucus.

Mr. Strachan and Dr. Wearing, if I've understood you correctly, you seem to think the present set-up under CEPA for the regulations in the line departments is okay as it is; we don't have to touch it. Would you agree the present CEPA, which says in the qualifying clause that CEPA:

do not apply in respect of

(a) a substance that is manufactured or imported for a use... under any other Act of Parliament

- the line departments -

that provides for notice to be given prior to the manufacture, import or sale of the substance and for an assessment of whether it is toxic;

In other words, it covers all the products of biotech. It requires that other departments will be in charge so long as notice is given prior to manufacture, import, or sale and so long as there is an assessment of whether it is toxic.

Do you agree with this?

Mr. Strachan: The various line departments, for example, with a biopharmaceutical product.... My company is developing a product called recombinant parathryoid hormone for the treatment of osteoporosis. It's quite a new way of treating osteoporosis. It's a product that was discovered here in Canada, at the University of Alberta, about thirty years ago. There is a very rigorous and intensive review process by the Health Protection Branch, the Bureau of Biologics, to investigate all aspects of production of this product, how it's manufactured, the standards under which it's manufactured, and the standards of the product at the end of the day. The product has to meet a very rigorously defined set of specifications that take into account not just efficacy but also safety.

Mr. Lincoln: Okay. What I'm driving at is that CEPA today says that provided notice is given prior to manufacture, provided within the line department there's a proper assessment of whether it's toxic, CEPA stands aside. If that doesn't happen, then CEPA interferes.

What do you see is the difference, then, between the existing provision, which I quoted, and section 68? Forget about section 69; section 68 says very much the same thing, except it defines it a little more clearly. It says there has to be a prior assessment, there have to be notification, assessment, and minimum standards, and if the line departments observe those, they're completely on their own.

Dr. Wearing: You are referring to subsection 26(3) -

Mr. Lincoln: Right.

Dr. Wearing: - of the current CEPA, which is very important and very basic to this issue. What has been used for ten years is that the line departments have addressed those issues of toxicity and have made modifications in some of the regulations to ensure that is done to the standards of CEPA - Environment Canada. So what you have is a line department making sure it assesses those concerns under subsection 26(3). The concern we're expressing here is that the line department would no longer do it but in effect Environment Canada would take the responsibility for that instead of the line departments making whatever changes are necessary.

So subsection 26(3) is the key subsection and it's a question of how that is achieved. We're suggesting the approach used, having a line department work in cooperation, is better than saying the line department can't handle it properly, so we'll have another department handle this part of the total product approval.

Mr. Lincoln: I must say, Dr. Wearing, this is a matter of interpretation. That's not how I read it, or the way it reads to me. It says:

Other federal statutes shall prevail over CEPA in regard to the environmental assessment of products only if their notification, assessment and regulatory standards are at least equivalent to those prescribed under CEPA.

If they are, then the line departments are on their own.

I see very little difference in principle with section 26, except this one is far clearer.

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Dr. Wearing: That's the way we had hoped it would be, and it was working until December 1994, when we were presented by Environment Canada with a ``template for plans'', which was four pages long. This told us that this was not something that Agriculture would bring forward with Environment's cooperation, but this would be a separate, gazetted template, as it was called. This is what alerted us to the fact that there was a proposed change in the way line regulatory responsibility -

Mr. Lincoln: Your opinion - and I think this is critical - is not based on the wording of the existing clause and the proposed clauses as a comparison; it's based on the template that you saw from Environment Canada separately. So it's not really clause 68.

Dr. Wearing: May I answer a question with a question? May I ask why you felt that you had to come forward with sections 68 and 69 if the current system is working? If line departments are addressing these issues, then why do we have to have this reinforced as the major recommendation in the standing committee report?

Mr. Lincoln: Maybe I'll mention one thing to you, that there's one regulation that was put forward by one line department where the key issue of environment and health - which is a quote from CEPA that is supposed to be reproduced in the line department regulations - was omitted. Perhaps what we wanted to make sure of is that in a world where biotechnology is becoming a huge issue nationally, and there are so many examples worldwide, Australia's and others, where these things sometimes have escaped the safety net, minimum standards should be very clearly set out so that, beyond these minimum standards, or equivalent to the minimum standards, the line departments are left completely alone.

At one point there has to be somewhere in an act, which is both health and environment, the only one we have... where we set minimum standards. I felt that section 68 made a lot of sense in that way.

Dr. Wearing: This is where we have a difference of opinion, because we believe that line departments, including Environment Canada in its area of responsibility, are doing a good job, and we question this need to say, in effect, no, they aren't, and therefore we need a safety clause.

Mr. Lincoln: If I understand, you would now prefer to see in the response the existing CEPA left as it is, rather than the modified recommendation that has come forward, the safety net.

Dr. Wearing: Our recommendation is that subsection 26(3) would stand and the line departments would address toxicity and environmental and human safety to your basic level, whatever standard Environment Canada feels is appropriate, but it would be under the responsibility and authority of the line department, whether it's Agriculture, Health, Environment, whatever act -

Mr. Lincoln: So you are for the status quo.

Dr. Wearing: No, we are for ensuring that under subsection 26(3) each line department will address this issue to the satisfaction of yourself, Environment Canada -

Mr. Lincoln: Yes, but I'm saying leaving 26(3) just as it is. That's what you're saying, in effect, in terms of legislation.

Dr. Wearing: Right.

The Chairman: Perhaps this committee should ask for that four-page so-called template that was referred to so we can have an idea of how Environment Canada has interpreted recommendation 68.

Mr. Adams.

Mr. Adams (Peterborough): Dr. Gadsby and gentlemen, this has been a very useful discussion of that particular issue. I want to comment on it.

This is not a question, because if you answer it as a question the chair won't give me an opportunity to discuss something else.

I think the response of the line departments - for example, the government's response to CEPA and so on - is actually paranoia rather than justified fear. If you will just read the government response, it is intended that CEPA should serve as the ``safety net'' for those areas that are not covered by other federal acts. Unless you're unjustifiably fearful, you have to read that as the line ministries having major control and the safety net being for the things that fall in between.

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Anyway, that's a comment.

I'd like to discuss this matter of regulation of biotechnological processes. A number of you have said to us we should focus on the products, that regulation should be of the product. I would like us to discuss that.

For example, in the production of beef, which I suppose is a biotechnological product if you define it broadly, we not only check out the beef but we control feedlots. That would be an example. What about in this biotechnological field, where you use all sorts of processes - by the way, processes that include living organisms and so on. Why is there this emphasis on not regulating the process?

Mr. David J. Gannon (Manager, Sheridan Park Environmental Laboratory, Zeneca Corp., Industrial Biotechnology Association of Canada): Certainly we don't intend there to be any emphasis on not regulating processes. They are regulated by a number of provincial and local laws. We're just saying CEPA... we're suggesting products that are important, that should be looked at... not how it was made. You could get an identical product made in three different ways. In assessing the product, if it was identical, the process it was made by would be irrelevant to the assessment. However, the process itself is, and should be, the subject of safety and occupational health control, and this is carried out at any fermentation plant or biotechnology production plant.

Mr. Adams: But the products are changing so quickly I assume the processes are changing very quickly. Can you give us some examples, outside of CEPA, of the way these processes - and I assume new processes - are being regulated so health and the environment are protected?

Mr. Walter: This concept of product versus process comes up over and over again. The difficulty with judging a process is that rather than looking at the inherent risk of a specific product, which can then encompass the process and encompass the biotechnology products as well as traditional products, if you are exclusively looking at process, then you're not necessarily considering the inherent risk. That becomes one of your criteria.

But you should recognize that the existing regulatory structure already looks at two fundamental understandings. The first is familiarity. The second is substantial equivalence. As soon as the regulatory authorities have no familiarity with the product, whether that's through its process or it's through its composition, or by a number of other criteria, that product already has a trigger for regulatory review. So the safety reviews are already undertaken when there is no familiarity.

So it covers process already, in fact. The process is in fact a trigger. It's just that it's not the fundamental trigger. The fundamental trigger is the inherent risk in the product.

Mr. Adams: Where the product, as seems to me quite often to be the case, is a living product, is it possible to separate the process from the product; beer, for example?

Ms Gadsby: In many cases you're absolutely right, the process is looked at as part of the statement of risk of the product. But we would like to see it maintained that first you look at the product and you have to look at the process that created that product. You need to know whether the process works reliably, what the quality of the product is, whether it's consistently of a safe nature or not. Certainly that part of the process has to be looked at when you look at the product. But what we're talking about is having the product be the trigger for what things get looked at and not the process.

If we divide a system to say if you have process A it needs to be regulated, if you have process B it needs to be regulated, and if you have process C it doesn't need to be regulated, then what do we do two weeks from now, when we create processes E through J? We won't know whether they need to be regulated or not regulated.

We're saying products that are going to be in the environment, products that are going for human consumption, need to be regulated. So the question is how do we go about it? We're saying that's based on familiarity. If we find we're not familiar with the product, then we need to look at the quality of that product, we need to look at the consistency, the reliability, the safety. We will go backwards through the process and ask some process questions, and the existing system does that, but the trigger isn't the process itself.

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Mr. Adams: By the way, we had this discussion before. Can you reassure us by giving us some examples, perhaps here or abroad, of process regulation, for want of a better word? I understand the point we are making, but people are concerned that there are these weird processes out there. It's not the responsibility of CEPA or something, you might say, or whatever it is. But could you give us some examples, particularly where it's this process C or E or F, this new thing that has appeared?

Ms Gadsby: I can give you an example easily, and that is the way Agriculture and Agri-Food Canada determined to regulate what it calls plants with novel traits. They took a conservative approach based on a model from OECD and said that it's not how we get a new plant that's important; it's that we have a new plant. We need to look at that and decide whether it is going to disrupt the environment in some way, whether it's going to disrupt agriculture in some way, and whether it's going to be safe for consumers to deal with. Agriculture and Agri-Food Canada decided that we shouldn't look on a process basis.

Herbicide-tolerant plants, for instance, fall in there, whether they're derived through mutagenesis, through biotechnology or through wide crosses. Basically they've set a net wider than on the international scene. Nowhere else around the world does this kind of product get regulated. This is the kind of product that has raised a lot of interest in the EU, because they recognize that this kind of product would escape in a process-based approach. They believe that's not necessarily wise in retrospect, that the Canadian system took an OECD suggestion, but it was the only country that took this one. It certainly exercises the abundance of caution.

Mr. Adams: So you use a plant. This is for reassurance. The concerns that are out there often don't involve plants. Say you are dealing with a bacterium; you develop a new bacterium. I don't know how it works, but you go through various types. That's the sort of thing in people's minds. So it's the same scenario dealing with this thing. It might escape or it might do something. Can you give me some examples of how that's dealt with? This is for reassurance. It's not a trick question.

Mr. Gannon: It would depend a little bit on what type of product it was. In the case of a bacterium being used for pharmaceutical production, you'd certainly have a complete validation of your process at each stage. As you scaled it up, you'd have to provide complete details of -

Mr. Adams: This regulation about that... like somebody says you are working with these bacteria; therefore there are rules -

Mr. Gannon: Yes, and you have to take measurements to see how workers are affected if there's any escape of the organism at all, etc. You have to go through a whole process as you scale up and go into production. There's a whole thing that is not CEPA. It's primarily provincial legislation, under health and safety acts.

Mr. Walter: Further to that, you'll find attached to my presentation a brief overview of a specific project called the microcosm validation project. That was the first multi-location introduction of a genetically altered or genetically engineered bacterium into the environment. That is just now moving ahead.

We have listed in there all of the regulatory organizations with which the project was discussed. There were some 20 Canadian organizations that had to be addressed in an attempt to determine the acceptability of carrying out that experiment. That's with a genetically engineered micro-organism.

The Chairman: I am sure everybody on this committee is intimately familiar with Pseudomonas aureofaciens.

Mr. Knutson, please.

Mr. Knutson (Elgin - Norfolk): I want to follow up on Mr. Lincoln's questions just for emphasis.

First of all, I have no difficulty with the concept that we want to avoid duplication or overlapping. We want the regulatory regime to be predictable, fair, reasonable and balanced. We want to allow these new products to come on-stream in a reasonable way so that the people who take the risk can receive the appropriate reward.

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I understand a lot of money and jobs are at stake. To a certain degree our standard of living over the next century depends on scientists doing their work and the system working along, and I endorse everything you said.

Quite frankly, though, I don't understand. The gist of the message I heard in the initial presentation was that you're concerned about overlap and duplication. You seem to be concerned about the things we said in the committee report and then the government response.

Specifically, in paragraph 7.4 on page 52 of the government response, it says:

where legislation exists, and regulations respecting notification and product assessment requirements to protect health and the environment are approved by the Governor in Council on the recommendation of the responsible Minister,

- and it doesn't say this, but I'll say such as the Minister of Agriculture or the Minister of Health -

CEPA would have no regulatory role.

Is that unclear?

Dr. Wearing: With the addition of the words you've put in, that is exactly what we're trying to propose. You referred to the appropriate minister.

Mr. Knutson: No, it says ``on the recommendation of the responsible Minister''. I didn't add that part. I added ``such as Ralph Goodale''.

A voice: I liked the one you said before.

Dr. Wearing: That is exactly what we're proposing, that there are several line departments taking responsibility for the safety of the environment and human health.

Mr. Knutson: So you're entirely happy with the government response on this as indicated in paragraph 7.4? I'm not trying to trick you.

Ms Gadsby: I think what you're seeing here is that we the industry have become confused because we've been in a consultation process for literally years on end. We got line departments up to speed on regulations that work and making commercial decisions, and now it's not clear to us exactly what the involvement of Environment Canada will be.

It's been suggested that other pieces of documentation would be put in in addition. This is what we hear in the corridors we work in. It's been suggested that with existing legislation, if the ink is dried, that would be covered, but is it ambiguous if the legislation is still under revision, if the line department is working on it? Is that a place where Environment Canada would be intervening?

I think what you're seeing is that these ambiguities we've been encountering have us confused. The letter of what's written there is one thing, but that's not necessarily what we seem to be experiencing in our lives.

Mr. Knutson: Well, I don't know what you're hearing in the hallways, but a law is a law when it's proclaimed in force, regulations are passed and there's a process. I've never heard anyone.... Well, that doesn't mean it doesn't exist, but I don't know why anyone would think a law is going to apply while it's still in draft form.

The Parliament of Canada has a role to play here, and I'd like to think we follow the rules once I vote on them and it's public.

But let me leave that. We can shadow-box all day with rumours you're hearing. I'm not the person to deal with the shadows; I just want to know for my own sake that the wording is fine. But let me go back to more fundamental points.

Dr. Wearing: We agree with the paragraph you read out. Where we have difficulty is when it goes on to talk about a safety net, which implies that in effect the ministers you referred to are not covering the area of concern. So we are fully supportive of the paragraph you read, but it then goes on to refer to a safety net, which implies that perhaps it won't be totally done.

Mr. Knutson: Let me come back to that point in a second.

Just to go back over some ground, you endorse the current regulatory regime. You say it works well and it's a model for other countries. It includes the current CEPA. There was one suggestion that it's a bit overburdensome compared to that of the States, but by and large the thrust of your message is the rules we have in place work well and we have great experts in the department.

In a world where things are changing at a more and more rapid rate every day, is it not unwise or imprudent to suggest that maybe there are going to be some changes that we don't anticipate, and all the expertise of the past is going to leave us unprepared for that, and consequently we need to pass, in the name in caution and public safety, a blanket minimum standard that otherwise might be called a safety net?

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Mr. Strachan: I think there are these minimum standards in the relevant product-related acts, such as the acts under which HPB operates. There are these minimum standards, certainly for pharmaceutical products.

I'm not sure what Environment Canada would add to these minimum standards. It would create yet another layer.

Mr. Knutson: No, the point is that something may come along that we haven't anticipated in the current act or regulatory regime.

Mr. Strachan: Isn't that the true meaning of the safety net?

Mr. Knutson: Yes. So do you endorse the concept that there should be a minimum standard that applies to all the things we haven't thought of and haven't been anticipating?

Mr. Strachan: But in relation to pharmaceutical products, these minimum standards should be and are defined by the relevant acts administered by HPB.

Mr. Knutson: Fine. If the laws in place anticipate the pharmaceutical developments for the next thousand years, then CEPA or the safety net doesn't apply.

Mr. Gannon: If an application comes along that's not even currently envisaged and is not covered by any of the agricultural or pharmaceutical standards, then it would naturally come into the CEPA anyway. It would be Environment Canada's responsibility. So in that case, that would happen automatically under the present CEPA, wouldn't it?

Mr. Knutson: Then you support that?

Mr. Gannon: Yes.

Mr. Knutson: I don't see the leap from a safety net meeting an overnet, a net that is on the bottom that catches the things that are missing and fall through the cracks, as being overlapping duplication. We can go around this all day, because you're responding to things you're hearing in the hallway, as you need to do.

Dr. Wearing: We're responding to written information that is provided. When we see the gazetting, we will know exactly what the situation is, but we were asked to seriously discover an Environment Canada document pertaining to plants.

If this had been an Agriculture Canada document with Environment Canada support, that would have been fine, but unfortunately that was not the case. So it is not hallway talk. I hope we will not see this happen, but it is a very real concern.

Mr. Knutson: Yes. I don't mean to be disrespectful. Perhaps ``hallway talk'' was a poor choice of language.

Again, from the wording I see, I don't see the leap, but I'm relatively new to the committee and I have lots to learn.

For one last time, though, you support the current regime, and for all its toughness, it's fair, it's reasonable. We allow people to make the money they need to make, get the rewards.

Mr. Strachan: I would say that we should never accept the status quo. We always should be seeking to improve, but we should build on what we have and the strengths we have.

I've made my point before that I think over the years we haven't paid enough attention to the training of regulators or making sure they remain au courant with scientific developments, that they communicate with their peers in other countries, other jurisdictions, in these things.

So, yes, there are always ways in which it can be improved. But fundamentally I think the system is predictable and ensures safe profits.

Mr. Knutson: And it's tough.

Mr. Strachan: You bet it is.

Mr. Gannon: I have a further comment, because under CEPA new substance certification regulations for bioproducts and biotechnology, those regulations are not yet in place. We've been in a consultative process on those and we have an idea of what they will look like, but until they're fully gazetted we can't say whether they'll be appropriate or not. We hope they will if we've been involved in the consultation.

Mr. Strachan: How many years will it take?

Mr. Gannon: Ten or nine or something like that - a long time anyway.

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The Chairman: Thank you, Mr. Knutson. That was very helpful. Evidently this exchange points in the direction of removing the confusion surrounding the terminology safety net.

Madame Kraft Sloan, followed by Madame Payne, please.

Mrs. Kraft Sloan (York - Simcoe): Thank you. In your presentations you indicated the concern you might have over regulatory regimes that would decrease competitiveness, etc. We all know that certain countries in the world, such as Japan, Germany, the United Kingdom and the European Union, do very well in the areas of world trade, competition and wealth creation. These are some of the wealthiest nations in the world.

Japan allows no release at all on genetically engineered micro-organisms. The Germans have very stringent regulations. The United Kingdom has some of the most stringent regulations around as well, and the European Union's release directive requires more information than CEPA would. So I'm wondering where your concerns are coming from around the trade and competition issue.

Ms Gadsby: I think we can probably answer that in two points. You mentioned microbials, so maybe I'll let David speak to that. But certainly the competitiveness issue is a real issue regardless of what the product is. It's a very real issue with the crop plants derived from biotechnology that we're either selling in Canada or putting on the export markets to go worldwide.

From a competitiveness point of view, I guess we can look at this from two points. I can say as a Canadian taxpayer that really what we've seen here is something we should be proud of as Canadians, because the regulatory clearances that have been given for the first products - crop plants of biotechnology that have been Canadian-derived data packages - are travelling the world and being ratified when they hit other shores.

When the Government of the United Kingdom gets the same data package, lo and behold, it comes to the same safety assessment. The United States takes the Canadian data package and comes to the same safety conclusions. The Japanese government has recently put its guidelines in place and is making similar kinds of determinations. So I think we can say that the Canadian standards that have been put in place are top-notch and high quality. If you can pass Canada you can pass the world. That's a very positive thing.

On the other hand, we have to decide whether Canadian requirements are actually a little more than might be required. If I can go sailing through in all of these other countries, and I really don't require an additional five studies that I conducted for Canada's benefit only, then I think, as Graham mentioned earlier, we have to continuously ask ourselves, as we become more familiar with these products, whether this requirement still makes sense.

We may have wanted it at one point when we were unfamiliar with the products, but as time goes on should we be considering whether that's really a necessary piece of data? It costs money and adds to the price - maybe it's not necessary.

Mr. Strachan: Perhaps I can address that in another way. If you think about Japan and Germany, these are countries that really do not figure as economic factors in modern biotechnology. There has been a lot of analysis and dissection of this. Germany is perhaps a good case in point, where laws and regulations were enacted that in essence drove the German pharmaceutical companies - the Hoechsts, the Bayers, the BASFs - out of Germany to make major billion dollar investments in the United States.

Just a month ago I visited a BASF manufacturing plant for recombinant proteins located in Worcester, just outside Boston, Massachusetts. It employs 2,300 people in a beautiful facility that it traditionally would have located in Germany. But because of the laws and regulations that applied in 1989 and 1990, it had no choice. It left Germany and located, with the creation of jobs and the multiplier effect, in the United States.

That's only one example. I could spend 50 minutes going through various other examples.

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The Germans have now woken up to the reality. I think it's common knowledge that the German economy is no longer very healthy, perhaps because it hasn't paid enough attention to the new emerging technologies or perhaps paid attention to the extent of the negative effect that has driven it out of the country.

There's a similar example in Japan. You don't think of Japan as a factor in modern biotechnology. The factors are the United States, which is the world leader, and Canada, which isn't too far behind. The U.K. is a world leader certainly in the pharmaceutical side. So that just addressed the economic impact in another way.

Mrs. Kraft Sloan: In your brief you said on page 8, under self-replicating species, that they don't normally persist in the environment and they're almost never found proliferating as weeds in uncultivated areas.

In a recent edition of Scientific American there was an article outlining studies that have been undertaken in Denmark, where they've been able to cross canola that had been genetically engineered to resist a common herbicide - you probably know it better than I do, glyphosate - with a relative in the weed category. They found that this was transmitted to future generations. So this is a documented case in terms of research that has been going on in the world that seems to contradict the statement you have here.

Ms Gadsby: It doesn't contradict it all, but I'd like to explain what you've seen there.

First, to back up a little bit, in the environmental assessment of plants that have novel traits, whether they're derived through biotechnology or not, one of the key aspects of that environmental assessment is the whole question of weediness. Do these plants have an ability to become weedier than their traditionally derived counterparts? There are many factors that are part of the whole weediness assessment. Certainly outcrossing is a key part of it, but there are other aspects to that assessment. It also involves invasiveness studies, competitiveness, the matter of seed dormancy, and the option of various controls. There's a great range of individual types of studies that are all put together to come up with a conclusion on the topic of weediness. You can't take those factors just piecemeal. You have to put them all together in that context.

What was reported in that Scientific American article is a paper that was also reported in Nature Canada recently. The news coverage it received was interesting. If you work in these areas of plant biotechnology, most people don't read these journals and they don't usually get picked up.

What they've responded to in that report is a very well-known kind of trial that's done very frequently. The first kind of work on that subject was done, I believe, in 1932. It is a well-documented scientific fact that canola of one type does outcross into canola of another type. It's well documented. Really the only reason it was published in that paper was that they used a slightly different method that had never been used before, but they came to the same conclusions. Those conclusions have already been factored into the Canadian environmental assessments with all the other information - the invasiveness information, the competitiveness information and the seed dormancy information.

To save you a great technical explanation of how all those pieces fit together, the bottom-line conclusion of the Agriculture and Agri-Food Canada people when they did this was that in the final analysis, one type of canola can safely be grown without jeopardizing the ability to produce a second kind of canola. The species of canola they refer to there as a weed is actually a commercial crop in Canada. So from our point of view, this isn't really a biotech issue, this is an issue of what traditional canola is. It has always behaved this way.

There is a good example to help us understand that this isn't an unmanageable problem. The example is that we have the ability to grow that second type of canola, which is a commercial crop grown in Canada, in pure stands in Canada. There are ways to do it with pure stands and there are ways not to. There is a way.

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In summary, then, this is not a new piece of information. It got a lot of headlines but it was well taken into account in the environmental assessments done in Canada. It's been ratified, and there is the same opinion by other world nations as well. It's not a problem that results from biotechnology. It's an ability to not increase the number of weeds, even though that is a true scientific fact.

The Chairman: There will be one final question, please.

Mrs. Kraft Sloan: I'm just wondering how many scientists within the Industrial Biotechnology Association of Canada study the impact of different biotechnical processes and products on the ecosystem. Within an ecological context, who is studying this?

Dr. Wearing: Perhaps I should respond to this. We have approximately 50 members. It is part of developing the regulatory package for assessment of the product. So these companies will either gather this through their staff, through their associated companies or through outside experts.

For instance, the outcrossing that -

Mrs. Kraft Sloan: Do they have eco-scientists working?

Dr. Wearing: Yes, indeed.

Mrs. Kraft Sloan: How many?

Ms Gadsby: It depends on the company, obviously. In my own company we have three people who do nothing but this and we contract out to consultants to help us along in this area. We also give grants in aid so the universities can do some of this research.

A lot of the outcrossing research that has been done in Canada has been done at the universities and at the Agriculture and Agri-Food Canada stations.

Dr. Wearing: We have four in our company and we are just adding a fifth. For instance, for the out-crossing that was just discussed, we went into that as our first step in 1985. We worked with Agriculture Canada on the question of outcrossing. These situations are addressed very seriously by very experienced people. It's important they be addressed in the information package brought forward for regulatory approval.

Mrs. Kraft Sloan: Thank you.

The Chairman: Thank you.

We have time, for those who are interested, for a quick second round of brief questions.Mrs. Payne and the chairman are on the list to complete the first rounds.

Mrs. Payne (St. John's West): Thank you, Mr. Chairman.

I have two points. I suppose they are at opposing ends of the spectrum. One has to do with something I think was in Dr. Wearing's presentation. He said there were two major concerns that have been raised. These were perceived risks about products of biotechnology.

One of the concerns I have has to do with aquaculture and fish farming. Right now aquaculture is being driven as an economic tool. All of the maritime provinces are looking at it as a means of creating employment.

My concern is that it is being pushed too far too quickly without due concern for what may happen. We're looking at the escape of a number of species of fish. We started with river trout and lake trout and now we've moved into other species, salmon and northern codfish.

I've seen some things that distress me greatly in terms of the kind of fish being produced and the chemicals being introduced into them. They tell us there are no means of escape. In fact, we know this is not true. We know there have been escapes that have taken place.

I'd like to have your comment on this. And on the opposite end, drugs and the treatments made available for certain diseases were mentioned earlier. Two of the diseases are osteoporosis and multiple sclerosis. Are we also waiting too long to use these treatments for diseases? Cancer of course is one that comes very quickly to everybody's mind. Are we in fact waiting too long in some cases before we make these treatments available to the general public?

Thank you, Mr. Chairman.

Dr. Wearing: Since I've done some research in Canada in the area of aquaculture, I might respond first to that. What you're referring to is the concern of cross-breeding between the cultured or farmed fish and the native fish. That was addressed approximately ten years ago by the Department of Fisheries and Oceans, which supported some research leading to a technique called tryploidy, in which you want in effect to ensure that the farmed fish cannot propagate with the wild fish. The Department of Fisheries and Oceans identified that concern and did some work, and that's one reason we were able to initiate work in Canada - because we already had the government addressing your key issue.

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Mrs. Payne: What about the transmission of disease?

Dr. Wearing: The basic concern is transmission, whether it be reproductive or disease. It's transmission from farmed to wild that's the basic concern, which you're very correctly addressing. Fortunately we have a government department that recognized that all of aquaculture would have to address this issue, and they got on with it approximately ten years ago.

Mrs. Payne: Is it addressed to your satisfaction? In Newfoundland right now we have a fish farm and I know there has been escape from it. I have no idea what chemicals may have been.... I just get the feeling that this process is taking place without any regulation or with very little regulation on the part of anybody.

Mr. Walter: Aquaculture is a new and rapidly developing area. As one point of clarification, in Canada there are no genetically engineered or transgenic fish currently grown on a commercial scale. Therefore there is no possibility for escape of transgenic fish. We don't use them in Canada on a commercial scale. They are used on a commercial scale in some other countries. In fact, some of our research has been exported to countries such as New Zealand and Scotland, where Canadian transgenic fish are now used in commercial production in those countries. They are not currently used in Canada.

On the second issue of the chemicals being introduced, I'm not really certain which chemicals you're concerned about. There are a number of feeds, there are some feed additives, and there are a very limited number of pharmaceuticals and vaccines for specific diseases, but those are already approved through Agriculture and Agri-Food Canada. I'm not really sure of the concept of chemicals per se or what you're trying to get at.

Mrs. Payne: When I say chemicals, I'm talking about the feeds given to these fish to create rapid growth.

Mr. Walter: The feeds are traditional animal feeds generated from fishmeal and other natural sources. There are some fishmeals, for example, that have specific micronutrients added. All of these are normally in pellet form or some other easy-to-distribute form and then are fed directly to the fish.

Mr. Strachan: I believe you had a subsidiary question relating to the drug approval process that maybe I could respond to.

In the nature of this business, and this reflects the rigorous regulatory standards, it takes somewhere between 10 and 12 years from discovery to the marketplace. For example 3TC, Biochem Pharma's reverse transcriptase inhibitor introduced to the marketplace earlier this year, was invented by Dr. Bernard Belleau, now unfortunately deceased, at the University of Montreal in 1986. So it took 10 years to bring to the marketplace.

It's a well-accepted scientific fact today that the combination of 3TC and AZT - and even better, 3TC, AZT and one of the new protease inhibitors of the HIV - will extend an AIDS sufferer's lifespan by 15 to 18 months. It's not perhaps an enormous long period of time, but for someone suffering from the disease it's a very significant period of time. Clearly if 3TC had been approved earlier, more AIDS sufferers could have taken advantage of this drug and prolonged their lifespan.

In point of fact, 3TC was approved in Canada for marketing very shortly after it was approved in the United States, so an informal system was at work here. The U.S. has a very formal process for life-threatening diseases, such as cancer and AIDS, of expedited approval, to shorten the process for life-threatening terminal diseases. It's something we should be thinking about here, although it does seem to operate informally.

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The Chairman: I must admit that listening to what has gone on in this room over the last hour and a half brought back to memory a story that was circulating in the late 1940s in Europe, telling about a convention of scientists where the Russian delegate took the floor and announced to the audience that in Russia they had managed to cross-breed the glow-worm with a bedbug so that the average peasant could read the newspaper in bed.

At that time it seemed to be an impossible task, but listening to you this morning, it seems as if we are rapidly approaching that solution to electricity problems.

Let me ask you for your definition of ``safety net''. Would any one of you like to answer that?

Mr. Walter: Certainly. The interpretation of ``safety net'' varies from individual organization to individual organization within the biotechnology community. As our organization understands the concept, it is through CEPA to provide a basic level of protection, especially for the products that fall outside of the existing regulatory structure of other acts.

That is to say that the existing line departments will retain their authority and their responsibility for regulating products that fall under their acts, and anything that falls outside of those acts falls into the safety net of CEPA.

The Chairman: So it is protecting the public interest. What is wrong with that definition?

Mr. Walter: I believe that definition, as I have stated it, is supported virtually universally by the biotechnology community.

The Chairman: Do you have any objection to that kind of safety net?

Mr. Walter: I have no objection to that kind of safety net.

The Chairman: So maybe there is no dispute.

Mr. Walter: I think the dispute comes only in the interpretation of how that is involved. If we have line departments that have traditional regulatory oversight of a product yet they do not have the authority to determine its environmental impact, we have duplication of effort, and we have a hazy system, a system that is not predictable.

It's important to recognize that the whole concept here also has to revolve around fairness - not only fairness to the general population, but also fairness to the innovators.

There is some concern by certain constituents in the biotechnology community that adding a layer of regulatory oversight, over and above what exists in existing line departments, for products that are presently being regulated under acts other than CEPA, for example, will add to the burden and the cost of developing products. That will make them non-competitive, and therefore is unfair. So the concept of fairness has to be dropped in here somewhere.

The Chairman: We have heard that the element of duplication is taken care of. If the fairness to the innovator is also taken into account, is it fair to conclude that you don't see any difficulty?

Mr. Walter: I see no difficulty in the scenario you have proposed here.

The Chairman: The other question has to do with a statement attributed to the Crop Protection Institute of Canada, which suggested that ``regulatory oversight through guidelines is the most effective way to administer regulatory requirements for biotechnology products'', emphasizing that guidelines will best serve the flexibility required to deal with future notification and assessment needs. What is your stand in relation to this statement?

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Ms Gadsby: As a member company of the Crop Protection Institute, we fully support that statement. I guess there has been some concern that if the line departments were dealing with guidelines for data requirements and submission processes, somehow that wasn't adequate.

It's the view of the Crop Protection Institute that it is fully adequate, that guidelines allow the flexibility to make rapid changes to them in an area where technology is changing, whereas regulations, because of their nature, are a more time-consuming process, and any change or progress with them is bogged down.

The Chairman: Thank you.

In the pursuit of the public interest, this committee is facing this polarization of thought, if I may put it that way. One you just reflected, namely that guidelines are preferable to regulations, and at least some elements in your industry prefer them. The other is represented by NGOs, who are stressing that environment and human health are to be protected by way of a regulatory system.

Are you engaged in a dialogue with those who propose the protection of the environment and health through a regulatory system, and if so, to what extent?

Mr. Walter: Possibly I could address that.

We in the CIB as well as other biotechnology organizations have a long-standing commitment to involve ourselves in the consultative process, both with governments and with other non-profit organizations, including the consumer organizations as well as the environmental organizations.

There are some specific examples of this. For example, a steering committee for a public forum has been struck and is presently chaired by Western Diversification. It includes a very broad cross-section of... I hate the word ``stakeholders'', but I'll suggest stakeholders or community participants, including groups as diverse as the Canadian Labour Congress, various church groups, the Canadian Environmental Network, the Industrial Biotechnology Association and a number of different government line departments. Those kinds of consultations have been going on for many years.

The Chairman: I realize the task of this committee would be made much easier if these consultations were to result in a common front, so to say, and a mutual supportive role, which may be possible. I don't know. Anyway, I appreciate your answer.

In the second round it will be helpful, Madame Guay, if you allow me to adopt a different sequence, because Mr. Lincoln has to chair a committee at 11 o'clock, so I will give him the floor first.

Mr. Lincoln.

Mr. Lincoln: I just have two questions, Mr. Chairman.

Dr. Strachan mentioned the AIDS biotech discovery, and of course we all rejoice that it will happen fast. I know there are so many examples, such as penicillin, of things that have saved the world. At the same time, we also could think about thalidomide, DDT and breast implants and all the things that may have happened too fast, which leads to my question.

I know we've talked a lot about cost and the competitive nature of the industry; in fact it's been the dominant theme. Would you agree or disagree that from the public order point of view, which we are about, the first criterion should always be human health and environmental safety?

Mr. Strachan: Safety, yes.

Mr. Lincoln: I mean safety in regard to human health, the general environment and the quality of life. Should that be the first criterion in all cases, by all of us?

Mr. Strachan: Yes.

Mr. Lincoln: You agree with that.

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I have just this one other question. If I have understood you well - and I want to get back to this point, because it's critical from our point of view - you have no problem with regulations that provide for prior notice regarding pre-manufacturing or that provide for assessment of potential toxicity as a standard related to environment, health and safety?

Mr. Strachan: That's what happens today.

Mr. Lincoln: In other words, you are saying that under CEPA subsection 26(3) this is already contained, so somehow you don't have any objection to this. What you have objection to is additional wordings that could cause arguments, confusion or ambiguity. Is that it? It's not the principles behind all this.

Mr. Strachan: No.

Mr. Lincoln: Thank you.

The Chairman: Thank you. That was very short. You are surprising us.

We have Madame Guay, s'il vous plaît.

[Translation]

Ms Guay: You know that there was a comprehensive one-year review of CEPA. On the one hand, industry is asking us for less stringent regulations and on the other hand, NGOs are demanding that CEPA be made much harsher.

As far as the security net is concerned, I can say that most stakeholders, except for the industry of course, have asked us that CEPA be used as a safety net in all areas.

You mentioned earlier a committee made up of NGOs. I would like to know how much this committee weighs on your decisions and your positions.

[English]

Mr. Walter: That committee specifically was established to look at issues that fell outside the existing regulatory purview of various government departments. It was set up to look at the socio-economic impacts of biotechnology and has a very broad objective, which is to attempt to discuss in an open setting the pros and cons of biotechnology as they relate to socio-economic issues.

I should point out, though, that there is continuing, ongoing and a long history of consultation on regulatory issues by each of the federal departments involved, which include virtually all of the organizations around that socio-economic table as well as a multitude of others.

So this is just yet another level of consultation. It just happens to be in respect to areas that are not presently under consultation or have not been previously under consultation through the regulatory line departments.

[Translation]

Ms Guay: You're talking about speeding up the approval process for drugs. I agree withMr. Lincoln that we do need some kind of process. It should be possible, however, to share informations with other countries that might have done an earlier review of a product and even some tests, instead of doing a brand new study ourselves. That product could then be marketed earlier. On the other hand, we still need to go through the whole process, step by step, otherwise we would be taking risks needlessly.

I'd like to ask a last question, if I may. I would like to discuss product labelling. Our committee had lenghty discussions on this issue and I must say that we had a hard time reaching a consensus. That's why I would like to hear what you think about it.

We discussed this hormone called bovine somatotropin for milk, for example. We said that people wanted to know what they were buying. They want it written on labels if it is used so that they can decide whether or not they are going to buy a product derived from biotechnology or a natural product. I would like to hear your opinion on this issue, because I think that you have discussed it.

[English]

Ms Gadsby: Could I just make a comment on the shared reviews while people are chatting here? I don't care about BST.

Some hon. members: Oh, oh!

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Ms Gadsby: I think the comment you made about the potential for work-saving through international cooperation is a very valid point. We have to give our regulators credit, because they have been involved for years now at the OECD and international working group levels. They are full participants in those. The next step, now that we have guidelines in place in the major countries, is to get to a position where there can be some data-sharing or work-sharing of the review process. Eventually we hope to get to a point where there would be mutual recognition of decisions. That would be efficient for everyone as long as we're all considering the same kinds of safety issues.

So I would say the regulators are working in that area and they are to be credited. We probably all need to make sure their ministers keep hearing the message again and again that international cooperation is important in an area where we are very small players in a global marketplace.

Mr. Walter: Further to that, in your question on labelling, as I was saying before, labelling is an extremely complex issue, as well as the rest of the discussion that revolves around information to consumers, which I believe is in fact the core of the concern. That will be discussed at length tomorrow, but I did want to point out that the concept for getting information to consumers is embraced by virtually the entire biotechnology community as a fundamental right.

There are different mechanisms to pass that type of information. One of those mechanisms may in fact be labelling, where it is suitable, where it is effective, where it's understandable to the population reading that label. There is a variety of other mechanisms to get that type of information - public education programs, 1-800 numbers and other mechanisms that include, if you're dealing in food items, for example, on-shelf display materials.

The important thing in labelling, though, I believe, is to ensure that nutritional changes and changes that would affect the health of the user be placed on the label. It's imperative. Again, I believe the vast majority of the biotechnology community absolutely supports the concept of labelling where issues of nutrition and health come to the fore.

I'll leave my comments at that so that you can discuss it in much greater detail tomorrow.

[Translation]

Ms Guay: Thank you.

The Chairman: Ms Kraft Sloan.

[English]

Mrs. Kraft Sloan: Some countries erect stringent environmental regulations around trade. For example, certain products are not allowed into their country because of adverse environmental impact. Are you concerned that this might occur in the biotech field?

Ms Gadsby: I think the position of each of us as individual companies would be that certainly every country has the sovereign right to make its own decisions. Where, because of the nature of the diet or the nature of the environment in a particular country, a safety assessment from another country is not found to be the entire set of information that needs to be considered, then I would say we all recognize that this country has the right to make its own decisions for itself.

What we're trying to do, though, is to work internationally to try to highlight the things that are common about all safety assessments, and if there are some unique aspects that only individual countries need to address, that those be made clearer so that the industry can then make a better determination at the outset whether this is a product that is bound for that country, yes or no, and whether the data package being developed is appropriate.

Mrs. Kraft Sloan: Would you know why Japan has banned the import of canola that's been genetically altered?

Ms Gadsby: They have not banned the import -

Mrs. Kraft Sloan: That's canola oil.

Ms Gadsby: They have not banned that. For the last several years the Japanese government has been working very diligently to establish guidelines. The last of their biotech guidelines was just ratified on April 19. They are working very diligently to get done each of the parts of the health and safety review. The first set of clearances for environmental clearance for the first set of seven products has been given. Two companies represented at this table have in their hands Japanese clearance for environmental approval for their products. We expect to have the other two remaining clearances by the fall of this year.

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So I think what you're seeing is that the Japanese government didn't have guidelines, has been working internationally to develop them and has set them up as much as possible in harmony with the guidelines in other nations. They've gone through the World Trade Organization to ensure they are not a trade barrier. As we speak, they are actually conducting the reviews to make their final decisions.

Mrs. Kraft Sloan: This is for canola oil.

Ms Gadsby: Yes. Seven products are under review right now. The potato is also included, as well as three canolas, some soybean, and I believe two corns.

Mrs. Kraft Sloan: I realize we're going to be talking about labelling tomorrow, but you'd raised the issue of public education and 1-800 lines. I'm wondering what occurs on these1-800 lines. What kind of information can the public get?

Mr. Walter: That varies by the opportunity. There certainly is a situation I'm aware of with the New Leaf potato, a genetically engineered potato to resist the Colorado potato beetle. It recently has been marketed, especially in the maritime provinces of Canada, through NatureMark brand. The 1-800 number that was established for that has a type of review questions/answers. It does have information on the genetic modification that was made, and it does have information on both the recipient organism and the donor organism.

Mrs. Kraft Sloan: Where does the consumer get information about the 1-800 number?

Mr. Walter: It's right on the bag of potatoes.

Mrs. Kraft Sloan: What other products have 1-800 lines?

Mr. Walter: A number of organizations have established either 1-800 numbers or centres for information. One of them would be the Fresh for Flavour Foundation, which is fairly widely known by grocery stores and consumer organizations. They retain information on various products, including those of biotechnology.

Mrs. Kraft Sloan: This is kind of new to me, so I'm just wondering where the consumer gets the information.

Mr. Walter: As well, there is an organization - you'll be speaking with them tomorrow - called the Food Biotechnology Centre, set up in the last few years. They retain information on all of the products that have received approval through Health Canada and Agriculture Canada and that are now on the market. They have information on products that are in the pipeline. They have specific product information as well as regulatory process information. They develop activities such as fora for various interested organizations to attend. They do have telephone, e-mail and web site material available, which has all of this on-line.

They are a very diverse organization, co-chaired by the Consumers' Association of Canada and Agriculture Canada. They have a membership that includes a number of the consumer associations, some of the industrial organizations as well as individuals from across the country.

Mrs. Kraft Sloan: Where does the consumer get information about the availability of these information lines and web sites?

Mr. Walter: Again, there is a number of ways. Admittedly, reaching out to 27 million Canadians is simply not possible. We have as a community attempted to reach out by bringing up to speed the organizations in close contact with the consumer - medical and health care professionals, dietitian organizations, the National Institute of Nutrition, the Canadian Consumers' Association as well as FNACQ and other consumer associations across the country - in an effort to bring them up to speed to know what the contacts are, what the locations of the information are, so that they can then pass that information on to their constituents.

As you may have seen, there has also been a number of newspaper articles. We put in a full-page advertisement in Canadian Living that simply gave very brief information on what some of the products might be and some contact information to get further information or details on those products.

Mrs. Kraft Sloan: But I guess for the consumer, when you're purchasing the product, it's a lot easier to have that information right there.

Mr. Walter: Point-of-purchase information is an excellent vehicle by which to get information across. One of the products I was mentioning -

Mrs. Kraft Sloan: Other than for the potato, what other products have that kind of information displayed?

Mr. Walter: We have very few products on the market right now which are, at the point of consumer purchasing... knowing absolutely that this is a biotechnology product.

We have Flavr Savr tomato, for example, approved in Canada, but it's not marketed here. So really, the potato is the first consumer-identifiable item that has gone through the system.

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Mrs. Kraft Sloan: Is this identified as a biotech product, then, the potato?

Mr. Walter: It was voluntarily labelled, I guess, or information was put on the package, claiming that it was a genetically modified potato.

Maybe Jack could give you a little more information. I have a broad understanding, but not specific.

Mrs. Kraft Sloan: Yes, because I don't see the difference between.... If you're going to make sure consumers have access to this information, then they have to know that the product is a biotech product. What's the difference between that, then, and labelling? Do you know what I mean?

Mr. Walter: I guess the fundamental question is what is the best mechanism -

Mrs. Kraft Sloan: If you have to ensure that a consumer knows there is a 1-800 line or whatever to contact to get information about the product, then you have to identify the product of the biotech product. In essence you're labelling, so I can't see the difference there.

Mr. Walter: I think you have to rephrase the question, i.e., what is the consumer actually looking to know? What is he or she trying to find out? I believe it's issues related to safety, and as I was saying, the other three areas -

Mrs. Kraft Sloan: Well, that's another question. My question is, what is the difference between posting a 1-800 number over potatoes or tomatoes to say you can get information because this is a biotech product, and saying this is a biotech product? There is no difference there. I'm talking about labelling. I'm not talking about what it is the consumer wants to know - because that's the next level. The consumer would like to know that this is a biotech product or a genetically manipulated product. The next level is that some consumers may want to know more information, so therefore they phone the 1-800 number, they write a letter or they do the e-mail thing.

Mr. Walter: That's a simpler question when you're working on something as straightforward as the potato, for example, which is an identifiable item. When you're dealing in the area of canola oil, it becomes much more complex.

Mrs. Kraft Sloan: Why?

Mr. Walter: Because there is a possibility, or a potential, to label the product if it is certain either to contain a genetically modified canola oil or if there is some other direct relationship. The difficulty is when you move downstream beyond that, because you have to make sure the information you're passing along is correct and accurate. It wouldn't help if every bottle of canola oil in the country said ``This may contain oil from genetically modified canola''.

Mrs. Kraft Sloan: In other words, on certain bottles of canola oil the consumer won't be able to get that background information. So your proposal of having labelling or public education can't work.

Mr. Walter: I think the two have to be combined. Labelling is one mechanism of getting information across about specific products in which the consumer has an interest, but there are other mechanisms.

If you're looking at canola oil, for example, the concept of labelling a canola oil bottle is a possibility, but do we also label the cake that has a very small ingredient of canola oil in it, or do we also label the can of stew that uses canola oil as one of the modifiers?

Mrs. Kraft Sloan: I suppose on your 1-800 line, when you say that canola oil is a biotech product and people phone in, they can find out all the other products that have this particular brand of canola oil in it. I don't know.

Ms Gadsby: The kinds of questions we've been getting from 1-800 or just mail inquiries is basically people wanting to know if the product is safe. In answer to that, we've been telling them basically how the product is regulated, that it has had a safety assessment done on it.

I think it's a sad fact of reality that a lot of our consumers today don't realize just how wonderful the Canadian food supply is and how highly regulated it is. They don't understand that normal canola oil is regulated in a manner to make sure that it was judged safe for their consumption. They don't quite understand yet that the biotech work has gone through the same product assessment, that it's also been determined to be safe.

Invariably, when we have given that information out to the public they have said okay - as long as it's safe. That's what they want to know. They don't care what bottle it's in. They just want to know it's safe.

Mrs. Kraft Sloan: But there may be people who decide - for example, vegetarians, and there are different types of vegetarians - for lifestyle or health or religious reasons that they cannot have certain kinds of things in their products. In the cake situation, they may want to know if animal fat is used in the shortening, etc. Therefore, there may be some individuals out there who want to know if the product they're consuming has a part that is genetically engineered.

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Ms Gadsby: Those kinds of examples have come up a lot, and I'm sure they'll be discussed tomorrow in the labelling group. But in reality, today we have no products on the market that would pose an allergenicity threat, no products on the market that contain, for instance, a plant containing an animal-derived gene, or any ones that might cause a religious concern, for example, in terms of kosher requirements. We don't have any products like that.

Certainly we in the industry are very well aware that those are consumer concerns. From an industry point of view, if we were going to make a proposal to put forward a product that would fall into any one of those three, we would have to go through an awful lot of internal scrutiny to determine how we would market such a product, because those kinds of products would clearly have to be handled in a different way from ones that can go through the process and be determined to be substantially equivalent to that thing you've been eating all along, safely.

Mrs. Kraft Sloan: But there may be a fourth category people would add to their list - genetically engineered.

The Chairman: Thank you. Mr. Knutson, one final question.

Mr. Knutson: I'm fine.

The Chairman: Madame Payne.

Mrs. Payne: No, thank you.

The Chairman: Could you give us the benefit of your views in relation to public participation? Do you see a role for public participation in decision-making in biotechnology regulation? Do you see a role for the public, that they would be given an avenue to file a notice of objection when it comes to the approval of import or manufacture or use or sale or export of a biotechnology product? Do you have any thoughts on this subject?

Dr. Wearing: I'm sorry, but I'm not sure I follow your question.

I did pick up the first part about full public consultation. I think that is taking place, and we certainly fully agree with it. In modern society, we have to show that what we are doing is fair, open to citizens and to in effect build trust and understanding in a very good Canadian regulatory system.

The Chairman: Could you give us some examples of successful public participation?

Dr. Wearing: I think we might talk about some of the biotechnology organizations across the country. You have Toronto Biotechnology Initiative in of course Toronto, BCBA in Vancouver, and there's one in the Atlantic provinces. So you have regional organizations who invite NGOs, environmentalists, etc., to address issues of concern. The FBC, which was spoken about earlier and will be participating tomorrow, has been involved in consultations across the country. I would think it's at about six cities now, but they can give you a full documentation on the conferences they have held.

I remember very well conferences where well-known environmentalists, well-known industry people and well-known government people have discussed and consulted in this area of new technology.

The Chairman: So your experience so far in public participation has been in the form of conferences. Is that what you're saying?

Dr. Wearing: I think it really has to be diverse. For instance, I remember one at the Ontario Science Centre involving particularly high school and younger people because of the centre location. I think you really have to reach out in consultation these days - different methods, different groups, but try to be open and fair in collecting input.

The Chairman: On the notice of objection where you had some difficulties, a process that would envisage a notice of objection is one where at a certain point in the procedure an individual or an organization could file such an objection. Have you any thoughts about that?

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Dr. Wearing: I'm reluctant to comment because I don't really understand the process or the procedure. Would one individual somewhere in the country be able pose a notice of objection?

The Chairman: Perhaps the law could set a limit or a minimum number of citizens who would qualify for an objection to a certain product. In some cases it could be possible for even two citizens to come forward and object to a certain initiative. It could be a larger number - it would depend on how the procedure was finalized. The concept is not a very complex one. It just permits the public to file an objection if there is such a desire.

Dr. Wearing: In effect, is it a veto by certain citizens over the government and the regulatory process?

The Chairman: It's not a veto, it's an opening of the process so an objection can be filed and then examined by the appropriate department in relation to a specific product. It would lead, evidently, to some review of that objection by a board that would determine whether this is a legitimate objection or not. That process would allow this kind of public intervention to take place.

Ms Gadsby: Certainly in the course of the regulatory guideline development, there have been lots of opportunities for the public to participate. I think that has been very useful. Having those people participate has moulded and shaped the guidelines that have evolved.

I know, certainly from personal experience, that the Government of Canada has gone to great lengths to explain to the public - either over the Internet lines or through decision documents, etc. - what is going on to make it clear to them. I know it has received letters from different individuals asking for more information, asking for clarity, sometimes stating that they have a different view of the situation. I think that has been productive.

The Chairman: Let me be more specific. If you have an authority that decides to build a dam that would affect the lifestyle of the people upstream, be they fishermen or people engaged in pleasure boating, in certain parts of the country the Environmental Assessment Act provides for an objection to be filed and examined. I'm giving you an example that takes place in certain jurisdictions in terms of environmental impact. I'm asking whether you can envisage a similar procedure in the field of biotechnology.

Ms Gadsby: We do not support that kind of thing because we see it as something that would cause delays. It could be used by political groups to influence a regulatory decision that had been made by experts in following the guidelines that have been laid forth.

The Chairman: I mean citizens without any political inclination - just a preoccupation.

Ms Gadsby: I agree absolutely. It could be either, but we think it's important to maintain a dialogue with people who have different opinions. It's important to educate people who have different opinions. I don't think that's a constructive way to do either of those things.

Mr. Gannon: We would prefer them to be part of the regulatory development process.

The Chairman: This brings us back - and we'll conclude perhaps with this - to the question posed earlier of whether you see the necessity for engaging in a dialogue with the proponents of a regulatory system for the protection of health and the environment.

There is evidently a polarization in the field between the views of industry and the views of the NGOs. Certainly it would be very helpful to see a dialogue between the two groups so that perhaps a rapprochement could be achieved, or at least a reduction in the gap between the two.

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To conclude, I think this was a very productive meeting. We made progress. We certainly understand better the definition of safety net, as you understand it and as we understand it. I think we covered that field quite extensively. I'm also glad to hear you coming out in support of the CEPA legislation as it exists now. This is also very helpful.

We look forward to our session tomorrow with some of you... or all of you, I don't know. It will be at 4 p.m. because of a brief ceremony at 3:30 p.m., arranged for this room by Mr. Marchi for an environmental award. Everybody who wishes is invited to attend. No champagne, though, I must admit.

Thank you very much. This meeting is adjourned.

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