EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, June 13, 1996

.0905

[English]

The Chairman: Good morning, bonjour.

I have a few announcements, if you don't mind.

[Translation]

The first announcement concerns the notes prepared by Kristen Douglas on the meetings of the Standing Committee on Environment and Sustainable Development relating to the 1996-1997 Main Estimates.

After the introduction, we shall turn to the list of causes for concern and the recommendations.

.0910

[English]

It is being circulated for you to look at and for your comments and/or changes on Monday when we meet in the afternoon. This report would then be forwarded, with a covering letter, to the Minister of the Environment and to the House leaders.

This is a way of giving some meaning to the meetings we held on the budget under the new scheme and to convey some of the observations that were made by you in the course of those hearings and which have been picked up by our researcher and put on paper in the form in front of you.

For those of you who have just arrived, the purpose of this paper is to leave it with you until Monday afternoon when we meet again, so that if changes are desirable they can then be made. Following that, this document, with a covering letter, will be forwarded to the Minister of the Environment and the House leaders. The content is the result of observations made by the committee during its hearings.

Number two: Tomorrow, in English and in French, the members of this committee will receive a draft report of the kind that seemed, at least to me as chair, to be a logical step for us to make after the meeting we held on... It seems a hundred years ago, but it was only Tuesday, I believe. Yes.

The content of the report is very simply an indication of the desirability of an interim report on our hearings on biotechnology and the desirability of a long-term report, giving the reasons.

I said it will be circulated tomorrow in both languages and then discussed on Monday for possible changes and adjustments. Again, therefore, I urge you to look at it over the weekend so that on Monday we can make real progress.

Yesterday we passed a motion, as you will notice, for the attendance of Dr. Curran to a conference here in Ottawa. It goes without saying that if the content of the conference has any relevance you think members of the committee ought to made aware of, it is entirely in your judgment as to whether to circulate a memo afterwards or not. It is entirely your decision.

There is a fourth item that slips from my memory and that I can't recall. Oh, yes. I wanted to raise this item here but we have so many other things to examine and to do that time is a very precious commodity here in Ottawa. There is nothing more... Well, that's an exaggeration. It is very educational for anyone who is interested in sustainability to find the time to visit a water purification plant and a sewage treatment plant to see how the system works and how the circle is closed, if you like. In September I will try to organize - if there is enough interest of course - a visit to the Ottawa plants that are considered to be fairly good or average. It would be a matter of two visits and it might be useful to those of you who have not made such a visit before. If you've done it before, of course, there's no need to make that visit.

.0915

Before the end of June the clerk will ask you who would be interested in this kind of field trip during the first week we are back. It would take an hour and a half for each plant and it would be over two separate days. For those of you who wish to come along, we will do it. I'll leave it in the clerk's competent hands to canvass the members.

Are there any comments or questions on these four items before we launch the meeting?

[Translation]

Mrs. Guay (Laurentides): Mr. Chairman, you were referring to water purification plants. There are various ways of treating sewage. I don't know how many kinds of plants there are in existence. Do you have any idea of the different treatments and the number of plants we can visit?

The Chairman: To the best of my knowledge, there is only one on the Ottawa side. If you are interested, we could visit another one elsewhere.

Ms. Guay: Yes, I'd like that.

The Chairman: We'll have to discuss it with Mr. Radford and if you have any particular recommendations to make...

[English]

Because it is not in your diary with your respective secretaries, please make a note that there will be a meeting of this committee on Monday afternoon as well as Tuesday, as already anticipated in your schedule. The Monday afternoon meeting is not in the schedule in your office.

We apologize to the witnesses for the delay. We are now ready to start. We welcome you to this committee in this marathon through biotechnology.

Mr. Banigan, you may want to introduce yourself and the members of your team.

Mr. John Banigan (Assistant Deputy Minister, Industry Sector, Industry Canada): Thank you, Mr. Chairman.

My name is John Banigan and I'm with Industry Canada. My position is assistant deputy minister for the industry sector. This is a group of 12 industry sector branches involved with industrial policy, trade and technology, one of which is our chemicals and biotechnology branch.Dr. Terry Walker, on my left, is a biotechnology specialist in that branch.

I must warn you, I am not a specialist in biotechnology, so with your permission some of the other witnesses will support me. On my right is Margaret Kenny, who is with Agriculture and Agri-Food Canada. She is associate director of biotechnology strategy and coordination. On her right is Dr. Desmond Mahon, who is with Environment Canada. He is chief of the new substances division, commercial chemicals branch.

If I may, Mr. Chairman, I understand you have a desire to learn about the national biotechnology strategy and some of the interdepartmental coordination that goes with that, so I've addressed my remarks to that subject.

The Chairman: Respecting departmental coordination, perhaps you could include some remarks that would explain to us why Industry Canada has been given the task of coordinating the entire exercise and not other departments. There must have been a rationality that we would like to hear about.

Mr. Banigan: Yes, I'll deal with that in my remarks, Mr. Chairman.

I am pleased to give you a brief history of the background of the national biotechnology strategy and Industry Canada's coordinating role in the interdepartmental committee structure that supports and guides this strategy. Copies of my presentation are available in both languages and I'll be happy to answer your questions on the strategy of the interdepartmental committee and our role with the national biotechnology strategy.

The national biotechnology strategy was approved by the government in 1983. A special fund, which was set at $11.9 million annually, was set up within the fiscal framework to support the NBS.

.0920

The strategy consists of four objectives: to focus biotechnology research and development on areas of strategic importance to Canada; to ensure an adequate supply of high-quality, trained human resources in biotechnology; to encourage communication and collaboration between researchers in different disciplines and sectors; and to create a climate conducive to investment by industry in biotechnology.

To support the strategy objectives the government recommended (1) that a biotechnology advisory committee be established to advise the minister of the then Ministry of State for Science and Technology, or MOSST, on policies required to promote the development of biotechnology in Canada, and MOSST provided the secretariat to that committee; (2) that an interdepartmental committee of officials on biotechnology, or the ICB, be established at the assistant deputy minister level, chaired by MOSST, which would also provide the secretariat function to review proposed government activities and monitor the progress of the strategy; (3) that the federal government research and development capability in biotechnology in the priority areas be strengthened; (4) that R and D networks be established in the priority areas to enhance collaboration and communication between producers and users of this research; (5) that exchanges of personnel among federal, provincial, and university research laboratories and industry be encouraged and financially supported; (6) that a cost-sharing program be established for industry to develop collaborative research and development projects with universities and provincial research organizations; (7) that an institute for biotechnology research be established in Montreal under the auspices of the National Research Council; and (8) that MOSST, in consultation with interested departments, review the need for changes to existing or planned regulations in light of developments in the field of biotechnology.

Because of its overall coordinating role in science and technology development in Canada, in 1983 the coordinating role for the strategy was given to MOSST. In 1988, when that ministry was incorporated into the then new Department of Regional Industrial Expansion to form the Department of Industry, Science and Technology, the biotechnology coordinating role became subsumed under the science and technology branch of the policy sector of the Department of Industry, Science and Technology.

In 1995, under Bill C-46, an act to establish the Department of Industry, the department was given a broad mandate to encourage the fullest and most efficient and effective development and use of science and technology and to foster and promote science and technology in Canada. Under this mandate, the department has continued to exercise a coordinating function for the federal activities in biotechnology by maintaining the secretariat function to the interdepartmental committee structures, calling meetings of the interdepartmental committees, and keeping departments informed of the international developments at the OECD.

The committee structure supporting the national biotechnology strategy is as follows.

First, there's the interdepartmental committee on biotechnology. Its first meeting, referred to above and chaired by MOSST, was held in May 1983. The committee was struck at the ADM level and consisted of the following departments: Agriculture; Energy, Mines and Resources; etc. They are listed. The science councils were represented by their presidents and the departments by their assistant deputy ministers. In 1985 the committee was expanded to include the departments listed here.

Initially the ICB held meetings at regular intervals to make policy decisions, but as the NBS became established a second committee, called the interdepartmental working group on biotechnology, now called the biotechnology coordinating group, was struck at the director or research coordinator level to assist in dealing with ongoing issues and coordination of departmental activities.

Some of the issues that have been or are being dealt with are the following: the allocation of funds under the NBS strategy; the 1991 federal review of the strategy; intellectual property issues; development of a coordinated communications strategy for biotechnology; biodiversity and biosafety conventions; and international collaboration, such as with the OECD.

The successful operation of the coordinating functions of the ICB contrasts strongly with other national and international jurisdictions. Cooperation of interchange between departments with regulatory authority has not been developed to improve the regulatory process. Little or no consideration has been given to the benefits that might be gained from collaboration between regulatory bodies, and no formal mechanisms exist abroad where different sectoral extremities can cooperate and share their regulatory experience.

.0925

A list of the current members of the interdepartmental coordinating committee, together with those departments that are invited to the meetings, is attached to this presentation.

I'd like to speak about the biotech coordinating group. Initially, the working group on biotechnology was chaired on a rotating basis. However, this led to confusion and breakdown in communications within the group. At the end of 1985, the ICB was asked to approve MOSST assuming both the chair and the secretariat functions on a permanent basis.

The interdepartmental working group on biotechnology was renamed the biotechnology coordinating group in 1986. The mandate of this group - which is more at the working level - is to provide a forum for early discussion of policy options and issues of mutual concern to the development of commercial biotechnology; develop recommendations on these policy issues for discussion by the ICB; provide scientific advice to the ICB on projects to be supported with the funds of the strategy, to strengthen government R and D; provide a link between the national biotech advisory committee - that is the external body - the ICB and the research networks; and coordinate network activities and ensure appropriate network information exchange.

This group meets at fairly regular intervals, normally five or six times a year, as required, to discuss active issues associated with the development of biotechnology in Canada. Departments have worked together to host multi-stakeholder workshops on regulatory, labelling, communications and ethics issues. There has been close interdepartmental cooperation in hosting workshops of international technical experts, to exchange information on the regulation of new products of biotechnology.

In the 1991 review of the national biotech strategy, departmental representatives worked closely to ensure that meaningful recommendations were put forward that all departments could endorse and adopt into their future work plans. A key result was that greater emphasis was placed on the regulatory aspects of biotechnology. Under the current three-year NBS fund allocations, more than 34% of the moneys allocated to departments will be spent on addressing the regulatory aspects of biotechnology.

There is another group called the subgroup on safety and regulations, which Margaret Kenny chairs. The subgroup on safety and regulations was formed in 1986 in response to increasing numbers of products that were perceived at that time to be reaching the commercialization stage. The subgroup reports to the ICB as and when required. Initially, the member departments of the subgroup were the ICB departments that had responsibility for developing regulations for biotechnology products under various federal acts. The membership of the group has now somewhat expanded, and at this time consists of the departments that are listed in my remarks. I won't read them.

Responsibility for chairing the subgroup rotates on a biennial basis among the three departments of Agriculture and Agri-Food Canada, Environment Canada and Health Canada. Agriculture and Agri-Food currently chairs the group. The secretariat function was at one time held by MOSST on an ongoing basis, but was devolved to the department chairing the subgroup.

Member departments of the subgroup also provide delegates to the biotechnology group of the OECD in Paris. Industry Canada provides the national coordinator for this group, and leads the delegation to Paris.

I will conclude my remarks with some comments on the funds for the national biotechnology strategy. At the time the funds were established, the responsibility for recommendations for the allocation of the funds was given to the minister responsible for MOSST. The funds were allocated every two or three years by means of a Treasury Board submission, prepared in full consultation and discussion with the interdepartmental bodies.

In recent years these funds have been reduced in line with general reductions in the federal budget. The allocation for 1995-96 was $10.115 million, a reduction of 15% from the original level. For each of 1996-97 and 1997-98, the allocation was $9.52 million, a reduction of 20% of the original level.

The allocation process was coordinated by Industry Canada, with the assistance of an impartial external facilitator. We strive to do this on a consensual basis.

.0930

A steering group was formed from departments represented on the ICB. Each department wishing to support projects with assistance from the funds provided a two-page summary of its proposals. Each proposal was evaluated by members of the steering group and given a score, based on how the proposal met the original objectives of the strategy - economic development, communications, development of skilled personnel, and improving the investment climate.

The steering group assigned final ratings to the projects based on numerical scores and technical merit. Fifty-one projects received funding, for a total of $17 million over the three-year period, and $11.456 million was allocated to NRC's IRAP program for industry development. Of the$17 million allocated to projects, Industry Canada received about $1.5 million, or 8.7% of the funds. Part of these funds goes for providing the secretariat.

Mr. Chairman, that concludes my remarks on the committee structure and the strategy. We'd be pleased to answer any questions you or your members may have.

The Chairman: All right. Thank you.

Ms Kenny.

Ms Margaret Kenny (Associate Director, Biotechnology Strategies and Coordination Office, Agriculture and Agri-Food Canada): Thank you very much, Mr. Chairman and members of the committee.

As Mr. Banigan has indicated, the subgroup on safety and regulations was established in 1986. It was mandated to examine the safety and regulatory issues associated with biotechnology, to provide advice on the adequacy of existing legislation, and to make recommendations for improving the regulatory system, as required. Its membership has already been discussed.

One of the first initiatives associated with the regulation of these new products of biotechnology began in 1987, when three departments - Agriculture, Environment, and Health - began to develop their guidelines to address the release of these organisms with novel traits into the environment.

To ensure consistency among these departments as we began to regulate these products with novel traits, they first agreed to use a standard definition of biotechnology. This definition, which you have heard many times before, is the definition that was ultimately used in the Canadian Environmental Protection Act.

At this time, several working principles were also agreed to among members. Interestingly, these principles ultimately served as the basis for the federal regulatory framework for biotechnology that was announced by cabinet in 1993. These are examples of some of the efforts that are made to ensure that we have consistency among the various departments.

Early on, the subgroup on safety and regulations recognized that there was a need to develop some kind of guide that would explain the federal government's regulatory system for biotechnology. So in 1988 a first draft of a document called Biotech Regulations, A User's Guide was published. This guide defined the nature and types of products that were regulated, what the legislative authorities were, departmental contacts for further information, types of permits and applications required, and how and where to apply for regulation.

The guide has been updated since then, and has also served as a basis for other departmental documents, such as the road map for biotechnology regulation that was published recently by Human Resources Development Canada. This latter document, although it deals with the federal regulations and guidelines that apply to biotechnology, emphasizes occupational health and safety. This is the kind of document that has grown out of the first initial joint undertaking.

There have been a number of key working groups established under the subgroup on safety and regulations. The biosafety working group is an example. It was created in 1988 and was charged with reviewing the role of biosafety committees in monitoring workplace hazards.

In 1990 the revised and expanded Medical Research Council and Health and Welfare laboratory safety guidelines were published. They actually defined appropriate laboratory practices. The status of this committee is complete.

.0935

As I've mentioned, there is a committee with the Biotech Regulations: A User's Guide. It is chaired by Health Canada and its status is ongoing.

There was also a committee for the good large-scale industrial practices working group. It was set up to review considerations of large-scale industrial practices and to determine the criteria genetically modified organisms must meet in order to be handled under large-scale conditions. The report was completed in 1995. This information was then provided to OECD and the mandate is over.

Another important working group concerns the Organization for Economic Cooperation and Development. This group prepares Canada's position on biotechnology for OECD meetings, particularly of the group of working parties on biotechnology.

There are two committees under biotechnology with the working party. One focuses on science and technology policy and the other, which Environment chairs, on regulatory matters and harmonization.

At this point, the subgroup on safety and regulations is currently examining the need to establish a new working group. As a signatory in 1992 to the United Nations Convention on Biological Diversity, Canada will participate in the development of an international protocol for biosafety. The purpose of this protocol is to set minimum safety standards and notification procedures for the transboundary movement of living organisms that have been modified and may pose concerns to biodiversity.

The subgroup on safety and regulations will meet to provide technical expertise and input into Canada's position for the development of this protocol.

In summary, the subgroup on safety and regulations really provides a backbone to the federal regulatory framework. Regular meetings provide a clearing house for information and a forum for specific issues, new projects and working groups.

The subgroup has also been involved for ten years in matters concerning the regulation of products of biotechnology. Draft guidelines and regulations for products of biotechnology are reviewed by this group prior to being released for general consultation. Members of the subgroup collectively agree to principles that ultimately formed the basis of the federal regulatory framework.

The subgroup continues to work to ensure there is consistency between regulatory authorities within different departments and is a link to international activities.

I would just like to point out that while I chair this committee, today we do have members of the committee who have served on it for quite a number of years: Dr. Terry Walker, Dr. Des Mahon, and Susan Hasnain, who is sitting behind us, from Health Canada. If it would be acceptable to the chairman, should we need some expertise from Health Canada and in particular Susan Hasnain's long-term memory, we would like to be able to invite her to the table.

The Chairman: It's not only acceptable, but most desirable. So please proceed.

[Translation]

Would you like to begin, Ms. Guay?

Ms. Guay: For some time now, we've heard from various groups on the development of biotechnology and we've heard different opinions reflecting perhaps different interests. Do you consider that the definition of biotechnology found in the Canadian Environmental Protection Act is a good one? Should we consider this act as our safety net in matters of development and biotechnology?

[English]

Mr. Banigan: Mr. Chairman, if I may, either Dr. Walker or Dr. Mahon would give a better-qualified response on the definition than I could. Maybe Dr. Mahon could start.

Dr. Desmond Mahon (Chief, New Substances Division, Toxics Pollution Prevention Directorate, Commercial Chemicals Branch, Environment Canada): Thank you,Mr. Chairman.

If I could take about 30 seconds to explain something, the definition of biotechnology we use comes from the Rio Declaration. It was discussed at length for several reasons. There are four basic reasons we use it. The first is that hazards naturally occur in organisms just as frequently as or possibly more frequently than they might occur in living modified or genetically modified organisms. So certainly for some of the legislation it was important we capture both the naturally occurring and the organisms that were going to be modified.

.0940

The second reason we retained and developed the definition is directly out of the OECD work. There was an initial step to set up regulations considering genetically modified organisms. The OECD set up an expert group to attempt to define which genetically modified organisms would fall under regulation. They met for four years and they disbanded without ever coming to an agreement because there is a vast range of opinion and a conflict of interest as to which organisms should be regulated under such an act and which should not. The classic examples are in the very defined approach of the United States, where the only organisms that would be regulated are transgenic organisms that code for new proteins. The Canadian and now the Swiss approach was that if you modify the organism, whether it is by what are sometimes called traditional means such as radiation mutagenesis or chemical mutagenesis, it is still genetically modified. So no agreement was reached.

The next reason is that when we examined organisms, whether naturally occurring or modified, we came to the conclusion there were no qualitative differences in the risks. The risks of an organism, whether it has been modified or not, are the same. There may be significant differences in the likelihood of those risks occurring, but we did not feel the risk itself differed significantly. As a consequence, we could look at the definition of biotechnology employed and say yes, this covers all the bases.

Then it is up to those departments developing regulations to ensure that within this they can address specific concerns relative to genetically modified, relative to naturally occurring, relative to the development of the organism per se and the characteristics of that organism, including anything resulting from a modification.

Thank you.

[Translation]

Ms. Guay: Could you give us more information about the role played by Canada in international cooperation and tell us what Canada's position is relating to the development of biotechnology?

[English]

Mr. Banigan: Perhaps Dr. Walker could best respond to this.

Dr. Terry Walker (Special Adviser, Biotechnology Regulations, Chemicals and Bio-Industries Branch, Industry Canada): There are a number of mechanisms used so we can keep in touch with what is happening in the international community. Environment Canada, Agriculture and Agri-Food Canada and Health Canada have very close relationships with their counterpart ministries down in the United States. These departments hold meetings on the regulation of biotechnology products on a regular basis, at least once every year and very often more frequently. In addition, Health Canada has close collaboration with its counterparts in the Food and Drug Administration on all areas of the regulation of biological drugs.

I'm sure Dr. Hasnain will correct me if I'm not exactly correct in this area.

In terms of the OECD, Canada has had a longstanding presence at what was initially called the group of national experts on safety in biotechnology. More recently the mandate of this group was changed and it became the working party on biotechnology.

Canada has worked consistently with the other 24 or 25 nations at the OECD to develop regulatory frameworks that are in harmony with what countries around the world are developing. Those countries are our trading partners. It is important that we are able to have an interchange of results and information on the regulation of these products. This has been done through a number of workshops held over the years. Some of those workshops have been hosted in Canada, held mainly in Ottawa. This enables our regulatory departments to gain from the experience of other regulatory departments around the world.

.0945

So I believe we have developed very effective collaboration with many international organizations.

The Chairman: Mr. Lincoln, please.

Mr. Lincoln (Lachine - Lac-Saint-Louis): I guess my questions will go to Mrs. Kenny and Dr. Mahon.

If I look at the strategy of your national biotechnology strategy group, what strikes me there is that I know a strategy is not a mission statement, but at the same time in these four main areas I don't see any qualifier that deals with the public good. It talks about areas of strategic importance to Canada without qualifying whether the strategic importance to Canada is quality of life or health or commercial development. In the fourth part it talks about a climate conducive to investment in biotechnology by industry. I was wondering if any of you feel that somehow, especially now - and I realize it wasn't the case then - now that we've signed the Convention on Biological Diversity and ratified it, there should be some mention in your main objectives to qualify that with the ethical side, the value side, the public good side, the environmental and health questions relating to biotechnology.

I say this because further on in the document I see the mandate of your coordinating group is issues of mutual concern to the development of commercial biotechnology. I was wondering if you don't see that there is need for some sort of a caveat somewhere, a qualifier, having the public good message.

Ms Kenny: I'm with the Department of Agriculture, and we don't oversee the national biotechnology strategy in the same way as Industry Canada does, but certainly from the regulatory... Well, I'll answer the first part of your question first.

I understand the national biotechnology strategy will be up for review very shortly. Perhaps Industry Canada can speak to that particular part of your question if there needs to be an amendment to the umbrella terms that define why it's in place. I would like to stress, though, that when we look at regulations and guidelines in a regulatory structure for the products of biotechnology, the public good and the good of the environment are foremost on the agenda. We concentrate on matters of whether or not a product would pose a risk to the environment or to human health in some way. That obviously is part and parcel even of why we have regulation.

Dr. Mahon: What Margaret has said is absolutely true. We have had ongoing discussions in the BCG and in part in the subgroup about the need to revise the strategy. The strategy as a document is ten years old. It was defined and written for a specific purpose, which at that point was to report to the minister. In generic terms the title is not correct, because I'm out of date, but at that time it might have been considered the minister of industry and technology. It was a strategy to promote the development of the industry. It is abundantly clear to all government departments, I think, that a strategy that is ten years old is probably out of date and should be revised.

The terms that are being considered and the scope of the strategy have not yet been defined. It is simply in the initial stages. But I would concur that from my department's perspective those sorts of issues are issues that must be considered in developing an outline of a new strategy for the public good. The public good is also the good of the industry.

.0950

Mr. Banigan: Mr. Lincoln, I may be able to supplement that.

In the act to form the Department of Industry in 1995, which subsumed the Ministry of State for Science and Technology, paragraph 5(a) says the minister is responsible for strengthening the national economy and promoting sustainable development. Sustainable development is an overarching policy theme that covers our whole approach to industrial development, so the public will certainly be implicit in that.

That said, the objectives of the program do go back to 1983. This year we'll have an interdepartmental process to modernize those.

Mr. Lincoln: Thank you for that reply. I would suggest that as you revise that strategy, it might be good if as many sectors as possible, and certainly the public, were to have input into this revision so that the value system part of it is reflected.

For instance, when you talk about your coordinating group that came afterwards, I know you talk about labelling and ethics issues. I think it might be nice if that part of it appears in the main strategy.

I have one last question. I see that you've mentioned that now you put a greater emphasis on developing and looking at regulations, and that more than 34% of the moneys allocated to line departments are now addressing the aspect of regulating biotechnology. Does that mean that 34% of the moneys are allocated to regulations in general? Can anybody tell me?

Mr. Banigan: The three-year plan that was approved by the Treasury Board entails some $29.15 million allocated across the various departments.

Mr. Lincoln: For what?

Mr. Banigan: For a variety of projects dealing with biotechnology.

Mr. Lincoln: It's for biotechnology?

Mr. Banigan: These are all biotechnology. Most of them are done in the member departments. Agriculture and Agri-Food, for example, has $3.9 million; the National Research Council has$3.7 million.

Mr. Lincoln: That's what I wanted to know. So what you're saying is that the money allocated to biotechnology is $29 million totally, from all the line departments, and you use 34% of that to develop regulations.

Mr. Banigan: That's correct.

Mr. Lincoln: Okay.

Yesterday there was a discussion with Dr. Bailey of the health department about regulations and guidelines. I think Ms Kenny and Dr. Mahon were there. Are you trying now to develop a system whereby you're going to make it possible for better and more efficient regulations to happen, rather than just using guidelines because they are simpler and more flexible? Is that the idea and the objective here?

In other words, within this coordinating group, within your subgroups that are looking at making regulations happen, are you trying to enhance and make more efficient the regulations that apply?

Ms Kenny: I will try to answer that question from agriculture's perspective and I knowMr. Mahon would want to speak to it from an environmental perspective.

The short answer to whether or not we are trying to make better regulations and enhance their efficiency is absolutely yes. That is fundamental in the development and review process of our regulations. In fact, one of the reasons for the subgroup on safety and regulations is that it provides a forum for all the member departments to review each other's regulations so that we can each benefit from the knowledge the other departments have gained as they have developed their regulations, as they have worked on enforcing their regulations, etc.

We also have heard a little bit today about the international fora we are involved in. We don't just stop at what we have learned here in Canada. We try to take it that extra distance and learn what we can from international approaches.

Mr. Lincoln: The specific reason I asked you is that yesterday Dr. Bailey seemed to say that between guidelines and regulations, you would opt for guidelines because they're more flexible and easier to put in place and, according to him, they're just as efficient. That's why I'm asking you about this specific point.

.0955

Ms Kenny: We do that as far as we can go, recognizing that technology is changing very fast. Today we have biotechnology. What's on the horizon for tomorrow? We've tried to keep our regulations broad enough so that they deal with the general questions and so we can ensure that we are going to examine all new products that might present a risk.

Mr. Lincoln: Do you have any other thoughts?

Dr. Mahon: Thank you, Mr. Lincoln.

Within the subgroup of safety regulations, we have not actually frequently discussed the approach taken by different departments as to using regulation versus guideline. We have primarily focused upon the content in any one. It has been left up to the individual department to determine what is the best approach for that department. Obviously, within Environment, for several reasons, the first of which is the act, which requires that we use regulation under those provisions of the act that refer to biotechnology, the new substance identification provisions...

I do not foresee a clash between flexibility as seen in regulations and in guidelines. I believe one can design a system that will accommodate flexibility either way. There is simply a different approach. I believe the same thing applies internationally. When we go to the OECD there are countries such as the United States that use an overview approach rather than regulation, compared to the EU, which uses an absolutely specific regulation. It is a regulatory directive. What must be done is laid down in detail in the directive.

We believe, I think, that there is a possibility to achieve the maximum results with an appropriate mix of regulation and guideline. Achieving that appropriate mix is not the easiest thing in the world, but that, I think, is becoming a more solid component of the discussions at the interdepartmental groups. I think that issue is rising.

The Chairman: Thank you.

Madam Kraft Sloan, followed by Mr. Adams, Mr. Knutson, Mr. Finlay and the chair.

Mrs. Kraft Sloan (York - Simcoe): In the first brief it was indicated that you'd been holding multi-stakeholder workshops on different kinds of things like labelling, communications and ethics issues. I'm wondering who the stakeholders are at those workshops. What kinds of issues are brought up by the stakeholders? Do the stakeholders bring up any solutions or suggestions as to how these things should be addressed?

[Translation]

The Chairman: Mr. Walker, can you answer?

[English]

Dr. Walker: A large number of our workshops have been held over about the past four or five years, sponsored either by Agriculture and Health or Agriculture and Environment or by a combination of the three main regulatory departments. They have tried to involve all possible persons who might want to come and give their views on the discussions of the draft regulations as they have been produced. They have included groups from very small public interest groups to the major public interest groups such as FNACQ and the Consumers' Association of Canada. As the federal government, we have tried to bring them all to the table and listen to their views, and wherever possible views of the disparate parties have been incorporated into drafts of regulations.

Ms Kenny: Actually, an example of one of these workshops is the one on risk assessment you discussed yesterday that Dr. Curran would be attending.

Mrs. Kraft Sloan: What is the range of issues that are brought forward?

.1000

Dr. Walker: I wasn't at the ethics workshop, but I believe there was a full-day workshop on ethical issues in biotechnology at which public interest groups were present. I was at the workshop on the labelling of food, which went on for two days. If I remember correctly, this was held in November 1993. At the same time there was a workshop in general on the release of biotechnology products to the environment.

Mrs. Kraft Sloan: But what were the issues that were brought forward, for example, at the labelling workshop?

Dr. Walker: At the labelling workshop the consumer associations in general were concerned that they should be able to judge whether or not to buy a product based on the fact it may have been produced from products of genetic engineering. As I believe Dr. Kenny mentioned earlier on, because the technology is so diverse, it's not always feasible to separate the products of genetic engineering from products that have been produced by other types of crop breeding methods. You can very often get the same result from conventional crop breeding as you can get through genetic engineering. Nevertheless, there was a full discussion on that issue.

Mrs. Kraft Sloan: I was also curious about the international biodiversity and biosafety conventions that were mentioned in here. Some of the issues that have been dealt with by the ICB-BCG include the biodiversity and biosafety conventions. What would some of these things be?

Dr. Walker: Mainly a discussion of the Canadian position that will be presented at the various meetings of the parties to the conventions. In fact, a meeting on biosafety is to be held in Copenhagen in July. The issue at that meeting will be the safe transfer of live genetically engineered organisms between countries.

I should say Canada respects the need of other countries to know when we are exporting genetically engineered products to other countries. The companies that are responsible for the production of those products are kept informed about the regulatory frameworks of those other countries and they take extreme care to ensure a product gains approval for use in another country before it is exported to that country.

Mrs. Kraft Sloan: Canada is a signatory to the Convention on Biological Diversity. I'm not familiar with this other area. What other conventions regarding biosafety is Canada a signatory to?

Dr. Walker: The biosafety convention is part of the biological diversity...

Dr. Mahon: There is more than one. There are a series of international approaches, either conventions or agreements, dealing with biosafety for biotechnology products. The one that has finally come to completion is the development of international technical guidelines on biosafety. These are guidelines that were adopted by the United Nations four months ago, I think, as guidelines to assist countries that do not have regulatory structures in place on how they could approach biosafety. As a United Nations document, it was developed by a working group of which Canada was a member in developing the guidelines.

That's one such document of the approaches we're dealing with. The second and specific one Dr. Walker has talked about and you have mentioned is the requirement under the Convention on Biological Diversity to consider the development of a protocol under the convention dealing with biosafety.

.1005

There have been several meetings held under the auspices of UNEP to deal with the idea of whether or not a protocol is required, what the scope of the protocol should be if it is required, and dealing eventually with what the content of the protocol should be. The first two or three meetings have determined that there is a requirement for a protocol. The meeting in Copenhagen will determine in part the structure or scope of that protocol.

The Canadian position has been developed under the chair of Mr. Herity, who is the director of the biodiversity office in Environment Canada. All the departments feed in their requirements for or their beliefs about shaping the Canadian position. That's what's currently happening.

Mrs. Kraft Sloan: Thank you.

The Chairman: Mr. Adams, please.

Mr. Adams (Peterborough): Thank you, Mr. Chair.

Some of you have been at these hearings before and you know we have a feeling that biotechnology is all-pervasive, and depending on the definition we use, I guess it actually is.

One of the fears that keeps cropping up is that something, some product, is going to slip through the cracks in the regulatory system or that it already has. It seems to me that these bureaucratic structures - and that's not a derogatory expression - you describe within Canada and between Canada and other countries are part of the attempt to seal these gaps in the system. Would you care to comment on that?

Mr. Banigan: Mr. Adams, I think that's precisely the purpose of these bureaucratic structures that work on consensus. You'll notice from the committee structure that the committee at the level of the assistant deputy minister is quite passive. It really is there to oversee the process. It's a working-level series of experts, who I think are best qualified to deal with these risks, technical and regulatory. I think that is the purpose of the mechanism.

Perhaps my colleagues from other departments would like to comment from their perspectives.

Ms Kenny: I think you've raised a very pertinent point. I would even go one step further. The focus we have given this has probably sealed off gaps with traditional technologies. We've taken this opportunity to ensure that, whether we're dealing with recombinant technology or traditional technologies, these gaps don't exist where there may be any organism derived by any means that would pose a risk to the environment or to human health.

Mr. Adams: Some of us, anyway, think it's important that these gaps be sealed. Do you think you have the resources? I've read the stuff and I've seen the amounts of money and so on that are concerned. This is not a question designed to say oh yes, we could do with another $1 billion or something like that. Do you feel at the moment, as these structures have built up, that you have enough resources? For example, in the international area, do we have enough resources to tap into what's going on in the international scene?

Dr. Walker: I would say that by and large we act as a group. Dr. Mahon has indicated a number of areas where he is active, I've indicated a specific area where I'm active, and Agriculture Canada is active in different international areas. I believe that through our combined efforts and the fact that we meet on a regular basis to discuss these international activities, we do by and large have the ability in our staff at this moment in time to cover off these activities.

Mr. Adams: I noticed that the Department of National Defence is a member of the coordinating group. I wonder what the Department of National Defence does in the area of biotechnology.

Mr. Banigan: I have some details of the project that was approved by the departmental group for the Department of National Defence. They had a project approved in the three-year plan for $191,000, which is entitled ``Establishment of a GMP-rated level C fermentation facility''. I don't think we can give you a better definition of that, unless Dr. Walker could.

Dr. Walker: Can I just enlarge on that, please? National Defence is not actually thinking of establishing a facility at this moment in time. The money was there in order to have an estimate, a proposal, put forward by consultants to determine where such a facility might go if it were built, how much it would cost, what it would entail.

.1010

In general, National Defence is at the biotechnology committees because it has to keep in touch with biological developments going on around the world, and because, as you know, biological weapons have been used in the past in warfare, and will continue to be used. National Defence needs to keep in touch with what's going on.

Mr. Adams: Given that the likelihood of risk-incurring increases because of genetic engineering - that's what I heard - and when we hear discussions to transfer live, genetically-engineered organisms across national boundaries, and given, as you know, my experience with biotech movies, where National Defence comes in at a particular place, I'm surprised that DND isn't on the subgroup on safety and regulation.

Dr. Mahon: Mr. Adams, I didn't say risk increases with genetic modification. I said for any particular type of risk, following a modification it may increase or it may decrease. We have to look to see, but it is likely to change a bit, and we don't know in which direction.

Mr. Adams: I'm sorry for the misinterpretation, but it is interesting. Again, given the preconception of biotechnology and how you deal with it, and the discussion of the possible role of DND in biotech, I would have thought National Defence would have been on the subgroup on safety and regulation.

Dr. Walker: Possibly, but the organisms National Defence might deal with - and I would like to emphasize ``might'' deal with - would in fact be regulated by Health Canada, because they would be living organisms that would or could be associated with health issues. Health Canada has a responsibility for regulating those organisms.

Mr. Adams: But it seems to me that in these movies it's very often an accidental occurrence. It is not something that's been deliberately developed by a nation. Isn't there an ultimate safety net against accidents?

Dr. Walker: Yes, that type of experimental work has to be thoroughly reviewed before it's even on the take. It would be reviewed by experts from Health Canada as well as National Defence.

Mr. Adams: Thank you.

The Chairman: Mr. Knutson, please, followed by Mr. Finlay.

Mr. Knutson (Elgin - Norfolk): Dr. Mahon, to go back to your initial comments, I thought I heard you say, when we were talking about the development of transgenic substances and materials or whatever, that it's not necessary that the risk changes but you accept that the likelihood of risk may change. I don't mean to be impertinent, but that really sounds like doublespeak to a lay person. If the likelihood of risk changes, then isn't that part of the risk?

Dr. Mahon: What I meant was that there is not a brand-new risk. If I were to use an example you've had before in the committee, taking a gene that produces a venom in a scorpion and transferring it into a Brazil nut -

Mr. Knutson: What about a virus?

Dr. Mahon: - or a virus... A virus may have a specific set of risks associated with it as a virus. The other gene, the venom, would have a set of risks associated with it as a venom. Putting the two together may significantly change the likelihood of the venom risk being expressed, that somebody would get sick because of the venom, because people are far more likely to eat Brazil nuts than they are to eat scorpions. It doesn't give rise to a totally new type of risk. It changes the likelihood of any one risk appearing.

So you have to examine it to look and see whether or not you've changed the likelihood of the risk.

Mr. Knutson: I don't want to debate semantics or threshold levels, but in part to satisfy the Canadian public - and in part just to do the right thing - I think the argument in part is that because this science is novel, we never know what we don't know. It therefore cries out to be treated differently - not to be feared, not to be turned away, because people recognize the incredible value and the prosperity going into the 21st century, what's at stake and the potential good that comes out of it, but to be treated more cautiously.

.1015

That may mean, in practical implications, a separate act to deal with the introduction of transgenic or genetically engineered material or substances. That act would be governed by either the Department of the Environment or the Department of National Health, not the Department of Industry or Agriculture, which might be considered proponents and as not having health and environmental concerns as paramount.

Can I just get your views on that thesis, which we talked about yesterday?

Dr. Mahon: Yes, if you will grace me with the idea that I'm a simple scientist, I'm not a policy-maker.

Mr. Knutson: But we're all experts in the public interest, right?

Dr. Mahon: Then I would give three parts to the answer. First, from what I've heard both at our own meetings and at the committee meetings, we collectively, including my own department, have done an absolutely rotten job of telling the public what we do and how we do it. I think that's the first issue. Obviously we have not persuaded the public that we are doing what we're meant to do.

The second part of the answer is that I firmly believe we do handle the risks, and we handle them within the content of the broader biotechnology regulations, but we clearly have not told people well enough that we do that. And yes, they are different, because when you have a modified organism, we request information on it and we look at it somewhat differently.

On the third component, the development of an act that deals only with transgenics, the only answer I could give is that it is at a policy level that is so far beyond me that I would not even dream of giving you an answer. Scientifically, there is no rationale to do so. Politically, it is a political issue that should be decided by policy-makers and politicians.

Mr. Knutson: We had an expert in risk assessment, and the cornerstone of his argument was that to have a department such as the Department of Industry or Agriculture, which represents a particular view on the jobs agenda, the economic development agenda, a view that might be different from that of Health or Environment, creates at least a prima facie case for a conflict of interest.

Dr. Mahon: Again, there's an absolutely basic premise. Whether it's at the governmental level, the department level, or whatever, there is a basic premise that the regulator must be visibly, and must be perceived to be, separate from the promoter, developer, producer. My department accepts that. We go to immense pains to ensure anybody involved in promotion does not contaminate the regulatory system. How far up the line should that go? Again, I believe it is a policy decision, as opposed to a technical decision. But the concept is absolutely valid.

Ms Kenny: You raise the point, should we be doing something different and something special for this kind of technology? On a couple of occasions we've discussed the fact that under each piece of legislation new guidelines have been developed, new regulations have been drafted, to ensure we are dealing adequately with the newness that comes from this kind of technology. So in that sense certainly something new has been done.

Mr. Knutson: Is there a down side to a new act?

Ms Kenny: I could envision a situation where we might have significant duplication. We'll use the Department of Agriculture, which I'm most familiar with. We're regulating a canola plant with herbicide resistance. We have this example. We have one that is developed through traditional means. That then would fall under the Department of Agriculture. We would then have another - we have this example - which has been developed through recombinant technology, and to anyone who can't look inside that plant it is identical. If there were a new act, that would be regulated under it, so the same kind of plant would be regulated by two entirely different agencies. There would be a concern of duplication of effort, I believe.

.1020

I would also suggest that if we're talking about a plant again, you have a structure in place where there is a great deal of knowledge, background and expertise with dealing with the plant. Now you've added a new piece.

Mr. Knutson: It's big piece, not a little one, and that's the point.

Ms Kenny: I would suggest that the plant is still rooted in the ground - it's still green and is ultimately still a plant.

Mr. Knutson: Even if it has a scorpion gene in it.

Ms Kenny: I think we could benefit from the background and knowledge we have.

The Chairman: Mr. Finlay, followed by the chair, and then we will have time for a quick second round.

Mr. Finlay (Oxford): I have two questions and one deals with the presentation Mr. Banigan made. The last paragraph at the bottom of page 3 confuses me. It says ``The successful operation of the coordinating function of the ICB contrasts strongly with other national and international jurisdictions.'' I don't know what that means. It sounds like we do it quite well, in your opinion. But the next sentence then says:

Cooperation of interchange between departments with regulatory authority has not been developed to improve the regulatory process; little or no consideration has been given to the benefits that might be gained from collaboration between regulatory bodies, and no formal mechanisms exist whereby different sectoral extremities can cooperate and share their regulatory experience.

I need some expansion of what you mean. It sounds like the ICB is trying to do something sub rosa or something, and it doesn't really collaborate. I'm confused.

Mr. Banigan: Mr. Finlay, I apologize for the lack of clarity there. I think we intended to mean that we think we have a good model in Canada of an interdepartmental consensus-based mechanism, which we don't observe in other countries, from our international exposure. We intended to indicate the lack of this coordination in other countries, not in Canada.

Mr. Finlay: So the last sentence doesn't apply to the ICB.

Mr. Banigan: We think this model should be emulated internationally.

Mr. Finlay: And it isn't.

Mr. Banigan: In our observation, it is not broadly emulated.

Mr. Finlay: That relieves my mind considerably. I'll take the negative and make it a positive.

Mr. Banigan: My apologies.

Mr. Finlay: My other question concerns CEPA and particularly something we also heard previously. The authority for notice and assessment of products of biotechnology under CEPA now resides in paragraph 26(3)(a) under ``substances new to Canada''. The section reads in part that CEPA does not apply to ``a substance that is manufactured or imported for a use that is regulated under any other Act of Parliament 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''.

Some of the witnesses who have appeared before this committee, notably from CELA and CIELAP, the Canadian Institute for Environmental Law and Policy, have stated that this section empowers Environment Canada, at least in theory, to intervene in the notice and assessment process for any product of biotechnology that in their view is not being assessed according to standards acceptable to the department. I presume that means the Department of Environment under CEPA. Do the witnesses agree with this interpretation of paragraph 26(3)(a)?

Is this interpretation of paragraph 26(3)(a) generally shared by the federal departments involved in regulating the products of biotechnology? Is this interpretation compatible with the January 1993 regulatory framework for biotechnology, which had as a stated principle to build on existing legislation and institutions, to clarify jurisdictional responsibilities and the avoidance of regulatory duplication?

Mr. Banigan: May I defer to my expert colleagues in that regard?

.1025

Ms Kenny: I will start. I certainly don't think it's news that there has been considerable debate about what that particular section means. I suggest, then, that the decision or proposal for no duplication made by cabinet in December was an attempt to provide clarification around the meaning of that particular section.

Mr. Finlay: But does it do that?

Ms Kenny: The concept that departments, with the legislation they currently have in place, will regulate these products of biotechnology that are covered under their acts and that there will be no duplication... I think the proposal put forward in December 1995 from cabinet does clarify that.

I don't want to speak for everyone around the table, but I don't believe there is an issue with the fact that we need a safety net under the Canadian Environmental Protection Act to ensure that some of these new products - I think we heard yesterday - maybe something that is seeding clouds, for example, or micro-organisms that would be used for bioremediation, a product that might clean up oil spills... We all agree they need to be regulated and we need a safety net to do that.

Dr. Mahon: Mr. Finlay, I'm in Environment Canada, so I know this section almost by heart now.

The specifics of the section - and we took legal advice on this - are that the law requires that all biotechnology products under the current CEPA... The authority to cover all of them resides in CEPA, just as a blanket statement. However, to avoid duplication and to make maximum use of the resources of the government in an area that is changing rapidly - as people have described - the lawmakers wrote in that where another act provides in law for notification and for an assessment of toxic as defined in CEPA, in paragraphs 11(a), (b) and (c), when that is in their regulation, those products regulated under those acts for those uses are exempt from notification to CEPA.

We have, obviously in consultation with our colleagues in all of the other departments, come to an agreement as to how the modifications to their regulations can be made to ensure they meet these legal requirements. When they meet that legal requirement, they are exempt from CEPA. Therefore, by definition there cannot be duplication, because either they are exempt from CEPA, in which case we do not apply, or they're not exempt from CEPA, in which case they must come to CEPA.

The interpretation or impression given by CIELAP that we, Environment Canada, can intervene in the assessment of a product that is under section 26 and not subject to CEPA is erroneous. If the legal requirement is met, CEPA does not apply. It is that simple under the current CEPA.

Mr. Finlay: Who decides that? Or is that come to as a consensus?

Dr. Mahon: No, it's not a consensus issue. It's a legal issue. There are two basic requirements. If those requirements are met under the legislation of another department, and if I may use the examples from my colleague from Agriculture and Agri-Food Canada, the proposed amendments or the amendments we've been working on under the Seeds Act now include in regulation a requirement to notify and a requirement to do an assessment. The assessment is for toxic, and toxic is defined in the definition section, paragraphs 11(a), (b) and (c) under CEPA.

That is the legal requirement. Once that has been met, seeds all go to the Seeds Act and CEPA cannot intervene. There is therefore no duplication.

Mr. Finlay: Okay, thank you.

The Chairman: Mr. Banigan and other witnesses, my line of questions is on the same wavelength, more or less, with that of Mr. Knutson, because I must confess to you that the more we proceed in these hearings the more I get disturbed from the perspective of the public. It is well known to all of us in this room that the public has a profound distrust of biotechnology and its products. We've seen it on so many occasions, not only through the proceedings of this committee but on others. This is why the question of labelling has become so virulent.

.1030

We have to ask ourselves, why is the public so suspicious, so distrustful? I concede to you, Mr. Banigan, that when you say we had a good model, from your perspective, within the system, you're entitled to say that. But from the outside the reality does not confirm it.

I'm very grateful for the historical perspective you have given us this morning. It is very helpful. From that we have learned there was a strategy in 1983 which contained four objectives, and then in 1993 we had six principles. Naturally the six principles of 1993 are, in my opinion, more comprehensive than the four objectives of 1983. Mr. Lincoln attempted to deal with them in his line of questioning.

We heard yesterday or the other day the merits of the example given through the experience with pesticides when two years ago the process was set into motion and the whole management of pesticides was reorganized. It seems to me some good principles were adopted there, because the distribution of responsibilities was narrowed and it was given to one department, very clearly, and a department that has no market ambitions nor responsibilities. It has a public responsibility, and the public has confidence in it. It is the panel of public health, right?

So the first question that comes to mind is this. Has anything now, after 13 years, been learned from the experience with pesticides? Secondly, why is the process not credible in the eyes of the public, we have to ask ourselves. Is it because the decision-making is so broadly distributed? You gave us this morning 21 agencies on this sheet - 21! In the end, who is responsible? Who is accountable? It's a miracle that you can function. Actually, we should congratulate you for being able to manage 21 agencies and to keep the sheep together. But from the outside one doesn't know who is responsible in the end, who is accountable. That explains, I suspect, the distrust on the part of the public.

Then another element in all this that is emerging and that is a bit disturbing is that in the system you have designed, some of you or many of you - I don't know how many - are at the same time regulators and promoters. Right? Well, that's our understanding, that Industry, for instance, is a promoter at the same time as it's a regulator. This is an item that has to be clarified, because that's our understanding.

.1035

Finally, you are the coordinating department, Industry Canada. There is no identifiable agency that is ultimately in charge. It is again a diffused responsiblity, so it brings us back again to the model of the pesticide management or regulating approach.

In the process itself, in the rationale of the process, as far as I've learned through the hearings in the last few weeks, there is a distinction between product and process upon which we dwelled a little bit yesterday. I think it was Mr. Knutson who raised the question as to why a distinction is made between the two. In the case of meat, both are the object of regulatory process, product and process. Why, in biotechnology, should there be a distinction between the two?

Perhaps you would please comment on the question of the credibility of the process, on its rationale and on its apparent lack of accountability and the reasons the public is so doubtful about biotechnology. It would be very helpful.

Mr. Banigan: Mr. Chairman, I certainly share your observation that the public lacks credibility. Consumers are concerned about biotechnology, and we've seen that in a number of recent files, such as rBST, for example. There is perhaps a credibility issue here.

One of the difficulties, I think, is that our department is called the Department of Industry but it in fact a rather broadly based department. This was the result of the merger of Consumer and Corporate Affairs and Investment Canada and Industry, Science and Technology and part of the Department of Communications. Despite its name, it's responsible for, of course, trade and industry, consumer affairs, science. Indeed, the coordination interdepartmentally for the science and technology strategy of Canada rests with Industry Canada, but it is a science perspective, not an industry perspective necessarily.

We are a regulatory department in many respects. I think there are some 47 statutes that we administer, but not in this domain. It is with regard to legal metrology, corporations, bankruptcy, weights and measures and that sort of thing. We are not a regulator when it comes to this particular area.

You mentioned, Mr. Chairman, that we managed the process. I'd like to respectfully beg to differ, if I may. We have no legal authority over this process. It's strictly a coordination task. The funds for the national biotechnology strategy are not in the A base of Industry Canada. It's a frozen allotment with Treasury Board.

We do a coordination job, interdepartmentally, and have an omnibus submission to the board which approves the funds. So we really are strictly a coordinator in that regard and the job could be done by somebody else, but historically it has been done by us and I am not aware of any bureaucratic objections to that. Really, the management is in two places.

With regard to the strategy, the management is with Treasury Board, which approves the funds as submitted from different departments, and of course the minister would sign the Treasury Board submission. The legal authority rests with the regulatory departments themselves.

The Chairman: We all know, Mr. Banigan, how visible Treasury Board is to the public, don't we?

Mr. Banigan: Yes, sir.

The regulatory authority rests with the various departments in health, environment, agriculture and so on. Clearly, there is a lack of transparency here and one model would be the pesticide model. If that helps to allay some public concerns about lack of accountability, perhaps it has some merit. I would suggest that even from an industrial perspective point of view, industry is concerned about the lack of consumer confidence -

The Chairman: That's right.

Mr. Banigan: - because their ambitions for a biotechnology industry are thwarted by the lack of public consensus about this. So they too have a stake in a safe and predictable regulatory regime.

.1040

Perhaps I may suggest, sir, that if your committee has some machinery recommendations, that would be something you need to make a recommendation on to the government. I'm often reminded that the machinery of the government is not the prerogative of officials but the government itself, the ministry, and we live with the machinery that the government gives us. But if you recommended something else that had greater transparency, that itself I think would be welcomed perhaps in a number of quarters.

Ms Kenny: If I could speak to at least the first part of your question in terms of agriculture, I would have to say that at Agriculture and Agri-Food Canada we do not perceive ourselves as being promoters of biotechnology. Obviously we have a responsibility within the department to make sure we can continue to feed ourselves in this country, but not as promoters of one particular type of technology.

When we develop the guidelines that are going to regulate this technology, that will certainly not be done in-house. We will get together a group of experts and outside interests.

If I could use the example of our plant guidelines that started in the early 1990s, we went to the University of Guelph. We had a professor who went across the country gathering information and he developed a model. The first thing we did was go to Environment Canada with that model and jointly worked to develop those guidelines that later went out for consultation.

We also, as we have said, work within the international context to gather the information that's pertinent to these types of guidelines. Once we have them, then we have to live by them.

We have refused field trials. We have plowed down field trials that did not respect the conditions we put under them. And I can say that we've done that on Agriculture Canada research stations.

The Chairman: Excuse me for interrupting. Were those guidelines the object of public scrutiny?

Ms Kenny: Yes.

The Chairman: In what way?

Ms Kenny: We have mailing lists and workshops.

The Chairman: No, I mean our parliamentary committee.

Ms Kenny: No, I don't believe our guidelines have gone to that. Our regulation certainly in that context will go through the standard regulatory process.

There is one point that I would raise. I'm not an expert on how this is unfolding and maybe this helps to address the issue of public perception, and I agree that we have a problem there that we need to address. It was announced in the last budget that Agriculture, Fisheries and Health were working together to form a single food inspection agency. My understanding of how this is unfolding is that Health Canada takes responsibility for setting policy and standards for food safety and the agency, this joint agency made up of former employees of those three departments, then is actually responsible for the inspection side.

I'm certainly not an expert on how this is unfolding. Certainly Ron Doering and Dr. Olson of Agriculture and Agri-Food Canada would be able to provide you with more information on that.

The Chairman: All right. Are there no further comments? For the second round, Madam Guay.

[Translation]

Ms. Guay: Perhaps Mr. Walker can answer my question. I have with me an article on rBST which calls into question the marketing of this hormone. It is noted that the United States started marketing it in November 1993 whereas the European community adopted a seven-year moratorium. It also notes that if rBST is used, this may cause the shutdown of a number of small dairies because of the inevitable rise in costs.

At one point we were talking about labelling. Many people claim that consumers are entitled to know what they are drinking. Some people however are opposed to labelling. Are the committee members ready to require specific labelling for products resulting from biotechnology?

.1045

[English]

Dr. Walker: Thank you. I'll try to answer that question to the best of my ability.

To take the last part of your question first, certainly I believe that where it is feasible to label the products of biotechnology, this should be done so the public can make the choice. Specifically in the case of milk that has been produced through the use of rBST, I believe in the States it is possible for them to separate streams of milk so that milk that has been produced without the use of rBST, in other words what one might call natural milk, can be labelled such that the label says that no rBST has been used in the production of that milk.

If ever Canada were to approve the use of rBST, and that is certainly not certain at this moment in time, I feel sure that milk producers would want to set up a similar system in Canada.

With regard to the European situation, there has been a moratorium placed on the use of rBST until the end of the century except in regard to experimental purposes. The moratorium really concerns the needs of the Europeans to find out more about the possible effect of rBST on the health of cows. It was for that reason they chose such a long moratorium of seven years.

Thank you.

[Translation]

Ms. Guay: You say that when it is feasible to label, it should be done. In my opinion, it's not just a question of possibility but of obligation. People should be able to know when a product results from biotechnology or when it is natural. I don't think of this as just a possibility, but something that should be done always.

[English]

Dr. Walker: When you use the word ``biotechnology'', as Dr. Kenny indicated earlier in the presentations, it can be used in a number of different ways. It doesn't just have to be the use of gene transfer from one product to another; it can be changes brought about in the plant itself through either chemical or physical mutagenesis techniques. Many of the products that we eat today are a result of that type of technology and it would be extremely difficult to try to differentiate all those products.

The Chairman: We will hear from Madam Payne, followed by Mr. Lincoln.

Mrs. Payne (St. John's West): Thank you, Mr. Chairman. I apologize for having to leave here for a little while; however, constituents are very important and I did have to meet with some.

I want to say that when I looked at the document that Dr. Banigan has presented here, I also was a bit amazed at the number of departments and agencies that are in there. I also wondered that this must be a rather cumbersome task to deal with all these.

My question, while it doesn't deal specifically with biotechnology, is a question of labelling. For instance, we in Newfoundland have a problem with the export of seal meat. I think Kenny referred to the single food infection agency. I know that this is a major problem because we have a problem exporting to the United States because we call it fish and they call it meat.

I'm just looking for some expansion on how you feel about that particular situation, and how you would deal with it. Even though biotechnology doesn't come into this question at this time, that doesn't mean that it won't at some future time, and I think there has to be a clarification.

.1050

Ms Kenny: You've raised a very good point, certainly, that emphasizes why we try to work cooperatively with our international trading partners, like the OECD, when we develop guidelines and rules, etc. Unfortunately, I am not an expert in this area, but I certainly know who is. I would be able to get you a written response to your question, if that would be helpful.

Mrs. Payne: It just raises the whole question of labelling, and I suppose I want to apply it to labelling in terms of biotechnology and the importance of noting what products are in fact included in the products we export.

Ms Kenny: Yes. Canada chairs the international committee on food labelling of the Codex Alimentarius food standard setting group, and we are actively involved in that for that very reason. It is critically important, or you have artificial trade barriers set up.

Mrs. Payne: I have a feeling that your question is probably relevant to the one I have in mind.

The Chairman: Please continue if you want to, Mrs. Payne.

Mrs. Payne: I was just wondering at what stage this process is and what's happening in that area right now in terms of being able to identify these products or these ingredients.

Ms Kenny: At the international level the meeting was held here in Ottawa of this food labelling committee. It would have been about a few weeks to a month ago. They brought up the subject that was on the agenda of labelling foods of biotechnology.

The decision that was taken was that the secretariat would be charged with drafting guidelines for this. This is in the very early stages of development. That will mean that once the guidelines have been drafted, they will be provided to member countries. Those countries then will consult within their own countries and bring them back to the table. It is in total an eight-step process, and we're just beginning.

Mrs. Payne: Thank you, Mr. Chairman.

The Chairman: Thank you. Mr. Lincoln, please.

Mr. Lincoln: I'd like to raise a couple of quick questions with Dr. Mahon. The first one relates to the present provisions of CEPA regarding biotechnology, which you referred to, saying that CIELAP or CELA, or both, were not quite correct in their interpretation. It doesn't cover all biotechnology substances because it provides that other acts apply. But isn't the big point that they are making this the big difference between what is there now and what is proposed? Isn't the big difference the fact that the provisions now are a reverse-onus provision?

In other words, CEPA applies to all that are under the definition of toxic. It applies to all imports, all modifications and all manufacturing. It has a qualification on environmental and health safety unless - and I think that is the big question - it applies to all. Do you agree with that? That's a very substantial difference.

I have seen proposed regulations myself that didn't contain the qualifications on environmental health and safety. They were proposed by line departments, so they wouldn't qualify under CEPA, so CEPA would automatically apply and be enforced. Do you agree with that?

Dr. Mahon: Yes, Mr. Lincoln, that's absolutely correct. It has been referred to as residual authority, but the residual authority is massive. The residual authority is 100%, unless somebody does something.

Mr. Lincoln: Right. I just wanted to make that distinction because I think that distinction is crucial.

Dr. Mahon: That is the current CEPA.

Mr. Lincoln: Okay, that's fine. So we agree.

In response to Mr. Knutson, in regard to the likelihood of risk, if I understood you right, you take the virus or the venom from a scorpion and add it to a Brazil nut. What you seemed to say was the likelihood of cumulative risk is not changed because you have taken the risk from one and the risk from another and the total likelihood is the same. Have I understood you rightly?

.1055

Dr. Mahon: No, I'm sorry, sir. What I've said is that you have a risk of a toxin and you have a risk, say, for an allergen in the nut. When you put them together, you can judge something about the toxin and you can judge something about the allergen, but you still have to do an overall risk assessment.

What we're saying is that by putting the toxin and the allergen together, you're not going to come up with a totally different type of risk. The qualitative risks are going to be the same. You've put a toxin and an allergen together. Putting those two together is highly unlikely to suddenly make the plant into a multilingual plant. Something new doesn't turn up. But the likelihood of the toxin being more available to people because it's in a nut, that changes. The likelihood of the allergen being more highly expressed, that may well change.

Mr. Lincoln: But are there not examples in other instances, in other fields, where when you join the two together they create a completely different type of risk that is unknown to us? And isn't that the problem with biotechnology and why the public is hesitant and suspicious?

Dr. Mahon: I would agree wholeheartedly with you, yes, that is the public concern. Again, in response to something that has come up over and over again, scientists generally do not believe that this is likely to happen, and I use the term ``likely''.

Mr. Lincoln: But it can.

Dr. Mahon: There is a finite possibility, yes. They are called secondary effects, whereby inserting pieces of genes into other genes you may have what's called co-activation. You may start something that was not normally active there. It's a very low likelihood, but we've done a rotten job of telling people how low that likelihood is on the basis of our knowledge, and we can only deal with the basis of our knowledge, it's true.

The Chairman: In the two minutes left, could you please say something about the logic of differentiating between process and product?

Ms Kenny: Are you asking me, Mr. Chairman?

The Chairman: Whoever.

Ms Kenny: I tried yesterday.

The Chairman: Yes, but you have to try again.

Ms Kenny: I will.

The Chairman: And why do you apply to biotechnology a differentiation and not in some of your traditional agricultural products?

Ms Kenny: I think if we were going to go back, I personally would not talk about product versus process because obviously it's very confusing.

The Chairman: Right. So what would you do instead?

Ms Kenny: I think I would describe it, rather than try to put a label on it this way.

What in fact we are doing...

The Chairman: I don't understand.

Ms Kenny: I will try to explain how it applies and what it is meant to say. What we mean to say is that the trigger we use to review a new product for its safety to human health and to the environment is not dependent upon a single process that is used to develop it. It is dependent upon the risk the particular product poses.

Having said that, if it is a traditional product or if it's a product from a new technology, if it poses a potential risk we are going to review it. In the course of that review, a fundamental piece of that is to look at the process that was used to derive the product.

We have in every set of guidelines and in our regulations a complete description of what we are going to look at. We ask questions like where you took the gene from; what the gene coded for; how the new gene was put into the plant; what kind of experiments have been done to show that it is stable, that it's where you think it is. Those kinds of questions are asked every time we deal with recombinant technology. If it was another type of technology, we would ask questions about that technology.

But the basic trigger we use to determine what to review is not the technology, it's the potential risk of the product.

The Chairman: You said that if it is a traditional product.

Ms Kenny: Yes.

The Chairman: And what if it is not a traditional product?

Ms Kenny: We would look at that as well.

The Chairman: And would you differentiate between process and product?

.1100

Ms Kenny: We would differentiate in our review because the review question might be how this product was derived, how it was manufactured or produced or developed. And then we would have to ask very specific questions towards that particular process so that we have done a thorough review.

The Chairman: Are you saying in essence that you would examine both process and product in the transgenic products?

Ms Kenny: We definitely review the process, but the process alone is not the trigger that causes us to carry out the review. But we review it.

The Chairman: Why do you do that with meat instead? When it comes to meat, you look at the process, don't you?

Ms Kenny: We do look at the process with these products as well. They are thoroughly reviewed.

The Chairman: We'll have to leave it for another meeting. We have to relinquish the room. But this was a very productive two hours. We will have to hear you again.

We thank you for your appearance, for your very comprehensive presentations. They are very helpful. Thank you very much.

The meeting is adjourned.

Return to Committee Home Page