[Recorded by Electronic Apparatus]
Thursday, May 16, 1996
.0840 
[English]
The Chairman: Order, please.
Good morning to all of you. We are gathered here today for the purpose of developing a better understanding of biotechnology. I am speaking, at least for myself, as a student who is eager to learn about the implications of that discipline and of the development that is beginning to shape the food we eat and the surroundings in which we operate. It is a topic that we, as a committee, decided to tackle with a little trepidation, because we do not know how we're going to fare with it. It is intellectually very challenging and the time available is short.
We are doing it for two reasons. One is related to CEPA and the government's response, and the other is that there seems to be a political vacuum in relation to biotechnology that somehow needs to be filled. So as you can see, we are a small group of parliamentarians planning to devote our time and energy to this subject in the next four or five weeks before the summer adjournment.
In the summer we will reflect on and absorb what we have learned, and in September, when we meet again, we will determine whether we are in a position to make specific recommendations to the bill. By then it may already be in the House, but it still could be modified if some acceptable recommendations are drafted for cabinet to consider. And if we don't have sensible recommendations to make, we won't.
I find it rather interesting to learn that as we sit here, in another place in Ottawa today there is an international conference on biotechnology under the auspices of the World Health Organization, I believe, where they are discussing, among other things, whether or not to label biotechnological products so as to alert the public to the content. So far, apparently only Norway and Finland have indicated their support for the labelling. Apparently the United States is opposed.
The question of biotechnology, of course, is not new. It has been brought to the attention of the public on a number of occasions. In looking quickly for some understandable literature - there's a lot about it that is not understandable to the normal human being - I came across two publications I would like to bring to the attention of my colleagues. One is the May issue of Policy Options - Options politiques, which is entirely devoted to biotechnology, from patenting to other aspects, but mainly patenting. I urge you to find some time to go through it. Another publication is by the Canadian Institute for Environmental Law and Policy, entitled The Citizen's Guide to Biotechnology. It can be obtained from their Toronto office.
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I'm sure there are other publications that deserve some attention and time. We have the entire next week off from Parliament, as you know, so we have lots of time to read and meditate while listening to our constituents at the same time.
And beginning these hearings with you this morning will help somehow to give us an understanding of where you come from on the question of biotechnology. I hope you will also give us an indication from your perspective of how the public interest can best be served by your respective departments.
That said, you can see that our committee members have their names at their seats, so I invite you to introduce yourselves and to decide in what order you want to make your presentations. Please make sure that we also have sufficient time for asking questions. Again, welcome to this committee.
Mr. Bruce Deacon (Director General and Manager, Coordination and Management Services Branch, Department of Industry): Thank you, Mr. Chairman. It's a pleasure for us to be here this morning.
Perhaps I could introduce my colleagues and then say a few words about our approach and what we hope to present to you this morning. I'm Bruce Deacon, from Industry Canada.
I would like to introduce Dr. Keith Bailey, from Health Canada, and Dr. Morrissey, from Agriculture and Agri-Food Canada. Also with me this morning are Dr. Terry Walker, from Industry Canada, and John Buccini, from Environment Canada.
We intend to give you four presentations this morning that largely indicate where each of our departments is playing in this important area of biotechnology. At the end of that we will entertain any questions. Our presentations are about 10 minutes each, and we are entirely in your hands as to when you would like to ask questions.
The Chairman: Yes, if you can keep it to 10 minutes each that will take us to 9:50. That will give us an hour for questions, as long as you keep it to 10 minutes.
Mr. Deacon: The presentations we were intending to give you this morning are largely intended to give you an overview of biotechnology, and, I guess, most importantly, are intended to give you an overview of where each of the departments in the government is playing on the issue and how those various players come together in terms of the management coordination of biotechnology development overall. The presentations will be in the order in which they were distributed to you.
Dr. Morrissey will deal with some of the history and the traditional development of biotechnology applications and will describe how this is being handled in the agrifood sector. Dr. Bailey will discuss the implications and how biotechnology plays in the drug and health sectors. Mr. Buccini will deal with the overarching issue of CEPA and how this fits into the broader regulatory framework. Lastly, Dr. Walker and I will deal with biotechnology purely from an industrial business point of view, and we will try to give you a sense of where this is going from a industrial development perspective. We will also give you the government's current response in terms of supporting and developing biotechnology.
If that's agreeable to you, Mr. Chairman, we'll proceed.
The Chairman: That's fine. Let's go.
Dr. J.B. Morrissey (Assistant Deputy Minister, Research Branch, Department of Agriculture and Agri-Food): Monsieur le président, mesdames et messieurs les députés, the text I've distributed is longer than the text I'll work from this morning. It is essentially the same, but I have abridged what I'll say to ensure there is time for questioning.
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During the next few minutes I'll attempt to define biotechnology, outline the four phases in its conceptual development, and hopefully summarize Agriculture and Agri-Food Canada's role in its assessment for safety and efficacy.
Biotechnology has been defined by federal regulatory departments as the application of science and engineering to the direct or indirect use of living organisms, or parts or products of living organisms, in their natural or modified forms. This is the CEPA definition, Mr. Chairman. Put simply, biotechnology is the application of technology to biology. Or put another way, it is the application of science to living organisms.
It can be conceived of as having passed through four phases. The first phase was during the beginnings of civilization and the emergence of agriculture. Humans started their first biotechnology activities by cultivation of plants and rearing of animals to provide food, fibre, and fuel. This early biotechnology continued with the selection of particular plants and particular animals more amenable to domestication. Examples are grasses familiar to us as cereals and certain animals from which descended our modern cows and chickens. From these early farming techniques sprang the use of living organisms, including, for example, the traditional biotechnologies involved in making bread or aging cheese.
Then came the second phase. As civilization became more sophisticated, this phase of biotechnology was further developed. Deliberate selective breeding was introduced. Humans learned to identify desirable characteristics in domesticated plants and animals and started breeding only those with the desired traits. Over the last hundred years or so, selective breeding involving the male and female of the species has been refined and has embraced the principles of classical genetics. Higher yielding varieties and breeds of animals were created.
In the late 1940s, scientists found their first evidence that the complex DNA molecule was the carrier of genetic information. This was the third phase. Subsequent research demonstrated the arrangement of only four basic units, known as bases, within the DNA molecule actually determined all traits of an organism. This is analogous, Mr. Chairman, to using a four-letter alphabet to send genetic messages. DNA can be found in the cells of all living organisms ranging from bacteria to cabbages.
What makes these organisms different from each other is the sequence of letters in the DNA bases. These bases are found in clusters or groups commonly known as genes. These genes determine an individual's traits and they're passed from one generation to another. It was in 1962 that Watson and Crick received the Nobel Prize for their work in this field. This work led to the new possibility of precisely transferring genes from one organism to another. This contrasts with the practice of traditional male-female crosses where large numbers of genes are mixed imprecisely.
The plant breeder, for example, is then left with having to check thousands of resulting progeny in the traditional male-female cross to find and select one with the desired combination of traits. It often takes many years to breed out random undesirable traits. Therefore, using the new tools of genetic engineering, genes can be isolated and transferred between the same species - between two corn plants, for example.
.0855
In the fourth phase, genes can be transferred between different species. Scientists are now applying this new tool to further improve the genetic characteristics of agriculturally important plants and animals. One focus is on improving natural disease resistance by copying nature's method of protecting against disease. Other applications include improving the nutritional qualities of foods; producing safer, more effective vaccines to prevent disease; and the use of micro-organisms to clean up pollution.
A recent example of a commercialized product is the NewLeaf potato. This potato has increased resistance to the Colorado potato beetle.
Thus, Mr. Chairman, the four phases described so far are: (1) the selection of particular plants; (2) the selective breeding of particular plants; (3) the transfer of genes between plants of the same species; and (4) the transfer of genes between plants of different species. Obviously these transfers could take place between any other organisms; I've simply picked plants for the purposes of illustration.
Finally, Mr. Chairman, I will give a short overview of agricultural legislation. Agriculture and Agri-Food Canada is responsible for administering several acts covering the safety and efficacy of agricultural products. This power includes the agronomic and ecological safety assessment of the products of biotechnological methods such as genetic engineering.
The legislation is based on a requirement that a product be safe and efficacious, regardless of how it was developed. Plants and forestry trees are regulated under the Seeds Act. The Feeds Act regulates livestock feeds. Veterinary biologics are regulated under the Health of Animals Act. These products, Mr. Chairman, are used for the prevention, treatment and diagnosis of infectious diseases of animals and include products such as vaccines and diagnostic kits.
Fertilizers are regulated under the Fertilizers Act. Microbial fertilizers have been used as alternatives to chemical-based products for many years, particularly as seed coatings.
Importation of plants, micro-organisms and animals is controlled through import permits under the Health of Animals Act and the Plant Protection Act. Import permit reviews examine the potential for a new imported plant, animal or micro-organism to have an ecological impact or to have adverse effects on human or animal safety.
The legislation, Mr. Chairman, does not categorize products based on the techniques used in their development. The safety and efficacy assessments are risk-based and apply to all products, regardless of the developmental method. It's for this reason that the Canadian regulatory system is said to regulate the product and not the process. As such, 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.
[Translation]
Mr. Chairman, members of Parliament, thank you.
The Chairman: Thank you, Mr. Morrissey. That was very well done, in less than ten minutes. Who has the floor now?
[English]
Dr. Bailey.
Dr. Keith Bailey (Director, Bureau of Biologics and Radiopharmaceuticals, Health Protection Branch, Health Canada): Mr. Chairman and members, thank you for the opportunity to present Health Canada's activities in biotechnology. I too shall present a somewhat abridged version of the text given to the committee.
Health Canada is involved in biotechnology in essentially two ways. We regulate products proposed for market and we conduct research. Research and development projects are providing the scientific basis for the new guidelines and procedures to ensure the safe application of biotechnology with respect to human health. They are also promoting human health through the development of tools to prevent, diagnose, and treat diseases.
This morning I will concentrate on the first activity I have mentioned, the regulation of products. The department has a responsibility to all Canadians to ensure biotech products regulated under Health Canada's purview are safe.
.0900
We are committed to a set of guiding principles. My colleague alluded to them just now. These guidelines for regulating products of biotechnology were announced in January 1993 by the departments. This regulatory framework and its principles reflect concern for the public interest. These principles are: to maintain Canada's high standards for the protection of the health of workers, the general public and the environment; to use existing legislation and regulatory institutions to clarify responsibilities and avoid duplication; to develop clear guidelines for evaluating products of biotechnology in harmony with national priorities and international standards; to provide for a sound scientific database on which to assess risk and evaluate products; to ensure that the development and enforcement of Canadian biotechnology regulations are open and include consultation; and to contribute to the prosperity and well-being of Canadians by fostering a favourable climate for investment, development, innovation and adoption of sustainable Canadian biotechnology products and processes.
Our current activities, therefore, build on existing legislation and institutions, clarifying jurisdictional responsibilities, avoiding duplication and using the long-standing expertise in specific commodity areas. This approach we believe to be both economically and scientifically sound, since it allows the regulators to build on existing knowledge and experience.
The use of product-specific legislation, as my colleague has mentioned, in the context of biotechnology ensures that the range of biotech products is covered by appropriate assessment and control in instruments and ensures a consistent and harmonized federal regulatory approach across the different departments.
A number of different legislative instruments in Health Canada relate to biotechnology: the Food and Drugs Act and regulations, which govern food and food additives; medical devices regulations; drug regulations, about which I shall speak shortly; the Pest Control Products Act and regulations, which govern all pest control products, including naturally occurring and genetically engineered micro-organisms; the Department of National Health and Welfare Act, which established the department, under which the importation of human pathogens regulations are fixed, governs the importation of various risk-group categories of micro-organisms; and the Canadian Environmental Protection Act and regulations, about which we shall hear later, govern enzymes and other chemicals and biopolymers produced through biotech processes, and micro-organisms used in pollution control, mineral leaching and so forth.
The situation may sound complex, but it may be clarified through some examples. I would like to offer you a few examples on the types of products Health Canada regulates, the first being drugs. Although biotech has become more prominent in recent years, and the ways in which biotech can be applied are increasing, the technology is not new, really, in the area of drug development. The use of organisms in the manufacture of drugs such as antibiotics and vaccines has been standard practice for decades. Extensive regulations to control the safety of these biological products, which are more stringent than those applied to chemical pharmaceuticals, were enacted long ago.
What is more recent, and what most people think of when they hear biotechnology, is the use of procedures involving recombinant DNA procedures. Here again, it is not exactly new. Schedule D to the Food and Drugs Act, which essentially defines what a biological drug is, was amended in 1982 to included drugs obtained by recombinant DNA procedures. The first recombinant-derived drug, human insulin, was approved in January 1983. There are now some 18 to 20 recombinant-derived drugs approved in Canada, and others pending. It is particularly important for drug products that would otherwise not be available because they occur naturally in very small amounts, or are traditionally isolated from human or animal sources where there is a risk of contamination with substances such as viruses, which could be harmful.
An example of that would be a recombinant human growth hormone previously obtained in minuscule amounts from human cadavers, and associated with the transmission of disease. Other examples include blood clotting factors, which are alternatively fractionated from human blood, and drug products that do not occur naturally, where the only source is biogenetic engineering - and biotechnology could be included - such as modified antibiotics to overcome problems of bacterial resistance.
We're hearing a great deal of gene therapy and somatic-cell therapists coming forward. These are expected to become of increasing importance in the treatment and indeed, perhaps, the true cure of many diseases and syndromes.
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The review process for biological drugs is especially thorough because it includes a review of the process of manufacture, not just a review of the final product. Medical devices that could be considered to be biotechnology products would primarily be diagnostic kits that must comply with the general provisions of the regulations and with schedule X. The regulations require that the device be safe and effective, and that evidence is available to prove its characteristics.
Turning to foods, about which you mentioned something earlier this morning, Mr. Chairman, Health Canada is a department with primary responsibility for matters of food safety. The branch has a place in its comprehensive system for the review of the safety of foods produced by biotechniques, including regulatory proposals to mandate free-market notification of such novel foods to the branch as biotech foods.
Officials in the branch evaluate the information and data submitted by the developers and conduct a thorough review of the safety of the product prior to rendering their opinions regarding the acceptability of the food for use in Canada. Guidelines for the safety assessment of novel foods have been issued.
Agriculture and Agri-Food Canada's role in the review process includes the responsibility for the review of the environmental safety of biotech-derived crops, as just discussed by Dr. Morrissey. To follow up on his example of the NewLeaf potato, Health Canada conducted the assessment of the new variety, which has been genetically modified to protect against Colorado potato beetle infestation. In this particular case, genes derived from a natural bacterium to provide protection from beetle attack were introduced.
This family of insecticidal proteins are naturally occurring and are included in certain commercial pest control products that have been used safely for more than 30 years to control insect pests by home gardeners, organic growers, and commercial producers. To date, some 13 crop varieties have been assessed by Health Canada, with the result that no objection has been taken to use of the product as food in Canada.
Food additive enzymes produced through the application of genetic modification are also reviewed under existing pre-market provisions of the food and drug regulations dealing with additives. An example is given in the text to do with the enzyme chymosin, used in the manufacture of cheese, which is traditionally obtained from cows, but now produced in micro-organism culture.
In pest control products, there is information on chemical pesticides and specific regulations are developed there. For more then 30 years, microbial pest control products have been registered in Canada for the control of insects. Again, the example of Bacillus thuringiensis, or Bt, which I have mentioned before, is provided in the text I have given.
When products are submitted for registration, they are evaluated for their safety, merit, and value, as are all pest control products. Specific data are required from the manufacturer before they can be approved.
The particular tests required are tailored to the organisms being examined. If the organism has been genetically engineered, particular attention is paid to the details of the genetic changes.
There's the Canadian Environmental Protection Act, about which my colleagues will be speaking further. The responsibilities of Health Canada are for assessing and managing health risks of the new substances, including biotech products under CEPA and these regulations. CEPA ensures that there is a legislative basis for assessing and controlling all biotech products, though not necessarily under CEPA itself. Under CEPA's new substances notification regulations, all new substances will be assessed for both potentially adverse effects on human health and the environment.
Last, there's the importation of human pathogens. The Laboratory Centre for Disease Control of the Department of Health regulates, through its office of biosafety, the importation of human pathogens into Canada. Guidelines for the large-scale production of micro-organisms have now been incorporated into the 1996 edition of Laboratory Biosafety Guidelines, which will assist the industry in the design and safe operation of large-scale facilities in Canada.
In closing, Mr. Chairman, I would like to confirm to the committee that Health Canada is committed to providing the environmental assessment of biotech products, which is the single-window approach or the one-window-shopping approach for regulating foods, drugs and medical devices under the Food and Drugs Act from an environmental, health and safety perspective. This is one part of our commitment with respect to Jobs and Growth, Building a More Innovative Economy.
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Thank you, Mr. Chairman and members.
The Chairman: Thank you, Dr. Bailey. Who's next?
Mr. Deacon: The next presentation will be on the CEPA regulatory framework.
The Chairman: Mr. Buccini.
Mr. John Buccini (Director, Commercial Chemicals Protection Branch, Environmental Protection Service, Department of the Environment): Thank you, Mr. Chairman.
The origins of the CEPA interests go back - I'm sure the chairman will remember - to around 1987-88, during the deliberations on the Canadian Environmental Protection Act. It was because of the concern at that time that was emerging with regard to the introduction of new products of biotechnology that the definition of biotechnology, which Dr. Morrissey has already read this morning, was developed and incorporated into CEPA in anticipation of future needs to deal with biotech under CEPA.
This definition was subsequently adopted, as Dr. Morrissey indicated, by the interdepartmental committee on biotechnology in 1993. It's now in fact providing a common definition of biotechnology across the federal government system.
In looking at legislation developed by other countries that deal with biotechnology, we've noticed that they tend to deal more specifically with genetically modified organisms. The term that's usually used for this type of legislation refers to them as ``gene acts''.
We point out that our definition really provides for a broader approach, allowing us to deal with exotic species, alien or non-native species or organisms, as well as the genetically modified organisms derived through any technology that changes the genetic make-up, including the newer molecular biologies, which Dr. Morrissey has described.
In the context of CEPA, we recognize that there is a consideration that we refer to as the carrying capacity of the environment. Whether we're talking about the sea and aquatic organisms or terrestrial systems, what we're actually concerned about is the ability of naturally occurring organisms, usually micro-organisms, to degrade potentially harmful pollutants to benign chemicals. These chemicals, in turn, become a food source for the bacteria.
You've heard from previous interventions from my colleagues on the programs of the health department and the agriculture department and the range of products with which they're concerned. I guess we're the clean-up squad. We deal, by difference, with what is left. So I'd like to mention the types of products that are of concern, at least the ones that we can anticipate within the CEPA purview.
Perhaps the most traditional one is the use of microbiological organisms in municipal and industrial waste-treatment processes. These have been referred to by various names. Perhaps ``sludge pond'' may be among the more descriptive. In these, populations of highly selected naturally occurring micro-organisms digest waste to clean it up prior to their discharge into receiving waters, whether freshwater or marine.
Another industrial application that would fall under the CEPA mandate includes the production and use of specialty products, such as industrial enzymes. These products would be used in very large volumes in such activities as the biological bleaching of pulp. They allow a movement from perhaps harsher chemical-based technology to a more environmentally friendly technology.
Industrial catalysts - we're talking here about the use of enzymes - is a rapidly growing technology driven by the move to cleaner industrial products and processes. As we move to cleaner products and processes, even moving away from the reduce-and-recycle approach, we want to move to pollution prevention based ideally on the approach of ``no generation, no release'' of pollutants. Biotechnology is emerging as a driving technology in this area.
The present objective is to develop cleaner processes and products, incorporating pollution-prevention technologies that are based on the use of biotechnologies in in-pipe or processing situations, and in the design of products that are biodegradable. One example is the changeover from metal-salt-based catalysts to biological-based catalysts in industrial processing. Here again, the example would be enzymes.
Other sectors in which biotechnologies have penetrated have been in the mining sector. So-called biomining and bioleaching are some of the more recent applications in which the industry has identified specific naturally occurring bacteria that can change the chemical characteristics of metal salts to make them water soluble. In this way, higher extraction efficiencies are achieved. The same process can be used to mobilize persistent metal pollutants.
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Bioremediation is the application of live organisms to remove pollutants from the air, soil or water. Again, this usually involves micro-organisms, but some plants are also used to, for example, accumulate heavy metals.
The most common use of biotechnology in the bioremediation, biomining and bioleaching industries at this time is the stimulation of naturally occurring populations of bacteria rather than genetic engineering. The difference here, of course, is that you isolate an organism that will do the job, but getting it in sufficient quantity and concentration, and then releasing it on a significantly larger scale, or a larger concentration than would normally be the case, is where the concerns would arise.
Newer technologies permit the transfer of genes that code for desirable properties from unusual or infrequently occurring bacteria into more common or more adaptable bacteria. In some cases, pathways for degrading difficult pollutants, such as polychlorinated biphenyls or polynuclear aromatic hydrocarbons, may come from plants or higher animals. These genes can be transferred into bacteria.
As I mentioned a few moments ago with regard to biomining and bioleaching, the notion that ``naturally occurring'' does not necessarily mean ``safe'' is one that underscores the approach in both our and CEPA's concerns. The power of our definition of biotechnology is that it permits the government to require an assessment of environmental and human health impacts before permitting large-scale environmental release of any new organism.
My colleague from Health has mentioned already the CEPA provisions. They are designed to protect both health and environment from possible new substances introduction, and they are really a judicious application of the precautionary principle.
While CEPA is the primary instrument in the federal government's array of tools for ensuring environmental protection, it has always been the tenet of the federal government that protection of the environment and human health is a shared responsibility within the government. I think we heard this morning how the Department of Agriculture and Agri-Food, as well as Health, are expressing interest in providing a measure of environmental review in the products they are looking at.
Under the new substances notification provisions of CEPA, the notifier, whether that is a manufacturer or importer, must provide sufficient information to Environment Canada and Health Canada to enable an assessment of the safety of a substance prior to its import or manufacture. The authority in the act permits the ministers to impose conditions on use - to mitigate exposure, that is - right up to and including a prohibition.
The way in which CEPA was written created a safety net characteristic. There are exemption provisions in section 26 of the act that allow for notification and assessment of new substances under other federal acts. The reasons for this are: the special expertise that resides in other government departments, such as Health and Agriculture and Agri-Food, especially on new specific products; biotechnology applications cover so many sectors that no one department could cover all applications adequately; and to preserve the client relationship of departments with sectoral responsibility is, we feel, a desirable objective of government programs. So the residual aspect of CEPA presupposes the safety net term that is now used to describe the CEPA applications.
The current provisions in CEPA enable the making of regulations, but I would point out that there are at present no regulations for biotechnology substances in effect under CEPA. CEPA therefore does not require notification assessment of new biotechnology substances. Work is continuing on the development of these regulations for biotechnology substances under CEPA as well as under other federal acts. Environment and Health have both worked with other government departments in the development of their regulations respecting the environmental and health safety aspects of the products they regulate.
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Last, but not least, how does what we do fit into the international context? We've learned a great deal from the approaches taken by other countries, including our major trading partners. Through this we've been able to avoid many problems that other countries are now attempting to rectify.
For example, the use of the gene law approach I mentioned earlier is one problem we've avoided. Another is the extremely rigid approach of some jurisdictions, which we've avoided by the extensive use of waivers and the use of expert judgment in the carrying out of assessments. Yet another is the claim that there has not been adequate public input into the regulatory system. I think this latter point is one where Canada is particularly strong in the way in which we engage the wide range of stakeholders in the development of our regulatory and other programs.
The draft CEPA regulations that are still in development have been developed in the context of international approaches to ensuring environmental and human safety. The primary organization we've used in this process over the past five years has been the OECD, and this relationship is continuing with significant Canadian input into the OECD program for harmonization of regulatory approaches for biotechnology.
Thank you very much, Mr. Chairman.
The Chairman: Thank you, Mr. Buccini.
Who is next? Is it Dr. Walker?
Mr. Deacon: I'll be speaking on the last section on the business side. My colleagues have largely talked about biotechnology from a scientific point of view, explaining to you what it is and how it has evolved, and from a regulatory point of view they have explained the approach that's been taken in the government to manage the products that result from biotechnology.
I'd like to come at the issue from quite a different perspective for a few minutes and give you a sense of how this is viewed largely from a business point of view. And that, I believe, will give you a sense of some of the pressures that will be arising for the regulatory framework, pressures that will come largely out of the demands from the business sector.
To put it in basic terms, from a business point of view this is a highly desirable, very targeted tool that changes not only your ability to produce products, but also your ability to develop new processes that are more competitive for the production of those products.
In general terms, the industry currently consists of about 500 firms, spread across Canada. They tend to be where the industry has concentrated in the sectors they are working in. The gross sales are currently in the order of $4 billion a year in Canada. About one-third of that is exported technology.
The industry has been exhibiting some increased concentration over the last few years. We are seeing more and more biotechnology being developed by the large multinationals for applications in product and process development. This is a trend that we expect to continue.
In the deck I distributed to you is a graph on page 4 that will give you a sense of the very rapid growth in the biotechnology sector in Canada. It has been growing on average at about 25% per year, and we see no reason for this not to continue. The bottom line, I guess, is that biotechnology will become a major factor of competitive production for about 25% of the Canadian economy.
Internationally, biotechnology is being implemented at an increasing rate, which will apply more and more pressure on Canadian firms to develop and implement biotechnology techniques.
The graph you have shows the rate of growth in the three major sectors, health care, agrifood, and environment. The health care sector has been increasing at roughly 17% per year over a period of time. The agrifood sector has been increasing at about 5% per year and the environmental sector at about 25% per year. Throughout this period our exports have remained roughly in proportion, increasing very slightly faster than the overall growth of the sector.
In Canada we are developing not only a capacity to develop biotechnology and implement it in Canadian industry, but also an export potential for the technologies themselves.
Now I'd like to touch on each of these three major blocks, from the point of view of how biotechnology is being viewed in each of those areas and what the size of that particular sector is.
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If you look at the agrifood and aquaculture sector - we're putting those together for the sake of simplicity - you have about 57 or 60 firms involved, and they employ about 6,000 people. As I said, the sector is growing at about 5% per year and is expected to continue or accelerate. This sector is responsible for about 8% of gross domestic product in Canada, and biotechnology is an increasing factor of production.
The example that we gave here - and my colleagues have referred to many other examples - is applicable in terms of genetically engineered applications. Herbicide-tolerant canola is an example. It now requires 50% less herbicide and that has a dramatic impact on reducing the environmental impact and, more importantly, on reducing the input costs and the costs of production.
A 50% change is merely one example of the orders of magnitude that the impact of biotechnology applications has in individual sectors. It's one of those technologies that is a tool. It is highly targeted. It may be costly, but the quantum impact it can have on how production takes place in sectors is enormous, and the net overall cost is then dramatically reduced. Factors of 50%, 80% and 60% are the norm. The impact of these technologies is on that order of magnitude.
When you turn to the health care sector, which includes drugs and diagnostics, you have about 116 firms across Canada, employing between 15,000 and 16,000 people. Employment, a good indicator of overall growth, is increasing at roughly 17% per year in this sector.
This sector is responsible for 10% of the gross domestic product, and it has a very major impact on the development of new drugs. About 50% of the current drugs undergoing testing have some degree of biotechnology included in the development or the production of those drugs.
The application is also enormous. It can be new drugs to treat diseases that formerly were untreatable. It can dramatically reduce chronic health-care costs. It can improve detection, hence earlier treatment with drugs, which, again, has a major impact on overall cost of treatment.
In simple terms, this is an application of the technology that can in fact radically reduce or have a major impact on overall health costs through very specific applications.
When you turn to the resource sector and the applications some of my colleagues have talked about in the areas of forestry, mining and the environment, there are about 130 firms involved in this area, with about 2,000 to 2,500 people employed. The rate of growth is about 25% per year.
That is the highest growth rate of the sectors, and in some respects this is indicative of the development of the biotechnology sector in Canada. It has been highly niche-oriented, highly targeted on applications, and highly targeted in areas of application where Canada has a major role internationally in terms of markets and production. Biotechnology here was viewed as the factor that would enable us to either sustain market share or increase market share. In other words, it's viewed as an international factor of competition.
In this whole area you have a very major increase in the use of biotechnology for bioremediation of toxic waste sites. This is in fact expected to become a $1 billion industry by the year 2000, increasing at a very significant rate, roughly 80% per year. The benefits are not unlike the other sectors. You have a very targeted application of a technology to resolve problems naturally. It is relatively inexpensive and it is ecologically sound.
The other applications are also of great interest and can have a major impact in other sectors of the economy, such as the production of renewable fuels.
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Biotechnology has the potential to not only expand the materials from which you can produce alternate fuels, but also to dramatically reduce the cost of the production of those fuels. If you have alternate fuel sources able to be produced at relatively low cost - this is implied, for example, in the auto sector - you now have an ability to radically change the overall cost of production of vehicles and the environmental impact the combustion engine has on the environment. Potentially, as a result of biotechnology development, you have a very significant shift.
Some of the other examples have already been mentioned: oil clean-up and recovery, and bacterial leaching of minerals and the change in the process.
I guess the last area I wanted to touch on, very briefly, is the growth of the overall market. The international market is growing at 20% per year. The market is dominated largely by the United States, which accounts for roughly 50%. Canadian firms will have to develop and introduce these technologies to remain competitive, particularly into the U.S. and North American market.
The impact of all this is an increasing pressure to put in place a regulatory framework enabling us to balance the competing pressures on biotechnology. Here there is a common interest with industry. Industry wants an effective but flexible regulatory framework that can permit development. There will be the pressure to do this on an increasing basis as the rate of adoption increases.
The last comment I'd like to make, Mr. Chairman, is on the role the departments play. My colleagues have described what each of their respective departments do. I'd like to comment very briefly on Industry Canada's role, which is to view activities from an industrial development perspective and to ensure technologies are developed and introduced that enable Canada to remain competitive. We also have to come at it from the point of view of consumer affairs, which is a responsibility of Industry Canada. We become heavily involved in issues such as intellectual property, patent legislation and regulation, etc. We play an interdepartmental role in terms of coordination of various activities. And Industry Canada plays the lead role in our international representations in the negotiation and the development of common approaches, particularly through OECD and with Europe.
Thank you, Mr. Chairman.
The Chairman: Thank you. Next?
Mr. Deacon: That is our presentation.
The Chairman: That ends your presentation.
Mr. Deacon: We'll be pleased to take any questions.
The Chairman: Fine. This gives us a good hour. I have on the list Mr. Forseth, then Mr. Adams and Mr. Lincoln. Mr. Forseth, would you like to start?
Mr. Forseth (New Westminster - Burnaby): Thank you, Mr. Chairman. We certainly were given a wide and varied presentation and I'm almost overwhelmed. But I might start with the broadest perspective.
There is a quote at the end of your text about this whole business we're entering into:
- Investment flows from nations with environments that are unfavorable to the development of
biotechnology to those with environments that are favorable to the sector.
We know that, given a market niche, there will always be some entrepreneur who will fill it. But based on our history, this may not necessarily be the wise thing to do. Technology and industry have always rushed in. We're trying to say we're going to thoroughly assess matters and make sure we're doing the right thing. But are we also stepping back and being careful and reflective?
Instead of saying it is a great thing to get into environmental and biodiversity industries, are we also reflecting on, at the higher level, whether this is really the wise thing for us to do? Maybe the wisest thing to do would be to call a halt or to say go slowly rather than just trying to beat out our competitors. We've got to also look at this, lest in a future generation we're in another mess all over again.
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Mr. Deacon: Perhaps the best way to address your question would be by looking at it from the point of view of a particular example. And Dr. Morrissey could discuss it from an agriculture perspective.
Dr. Morrissey: Thank you very much, Bruce.
Mr. Forseth, what struck me as you spoke was the term ``favourable environment'', and I guess the issue hinges on what we mean by favourable.
A little while back I saw the video Michael Porter used to back up his book. I believe it was called The Competitive Advantage of Nations. He had surveyed the biotech clusters that have developed in the New England states. What he found there was industries moved into those states not just because of any laxity or ease of biotech regulations. They moved in for two reasons. One was the regulations and requirements were strict, stringent and on a par with the best and toughest in the world. But the second point is the key one: they were predictable. In other words, a company about to invest money for ten years before ever having a product to sell knew what those tough, stringent, safe requirements were eight or ten years in advance.
I guess the key point coming out of this was a favourable regulatory setting meant to this group in industry strict, respected, stringent but predictable requirements. So it really goes back to using the old principle of the predictable rule of law rather than the whim of bureaucrats as a basis for decision-making.
Thank you, Mr. Chairman.
Mr. Forseth: I'll take it down to a very practical level and look at the second presentation where they talked about the Bt family of insecticidal proteins. I guess one of the products of this is the Bt spray used for the gypsy moth. I take it the gypsy moth makes nests on freighters, comes into port and then leaves the freighters. It gets out onto the trees of the west coast and is not part of the ordinary ecosystem of the region. It is really seen as a potential threat. So we've got Agriculture Canada wanting to go out into the community and spray this Bt spray.
Well, this really became a problem in our local community. Residents are all up in arms, not necessarily about the Bt enzyme itself, but about just how it's going to be sprayed and when, and whether or not the community will be involved. People want to know what propellants, carriers or chemicals are used to get this stuff out into the community.
Also, there is the whole business of a federal bureaucracy interacting with the community and saying when certain thresholds have been reached community spraying is necessary. There is the question of doing this rather than getting involved with the community, having each property owner manage some traps, not choosing to go with the high-tech spray but looking at trapping and getting the local resident to be responsible for his own property.
So we can talk about these things at a very high level, but at some point it comes down to very simple things on the local street and the block.
I've received a lot of complaints about people trying to react to this whole system. The poor city council receives the delegations because these people don't know where else to go to complain or to say ``Hey, stop this; we need more information and we want to be responsible for our own property.''
So the Bt spraying issue is not a new one. It's been a political football kicked around in Vancouver for quite some time. But it's an issue that has now come up again in my riding and residents are very upset. So I would like to hear someone talk about the practical, pragmatic application and doing the right thing in the community.
Dr. Morrissey: Thank you, Mr. Chairman. I guess this question has two parts. One is with Health Canada and the human aspect. The other is with Agriculture Canada and our colleagues in Environment and concerns the agronomic and ecological aspects.
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On initial observation, the gypsy moth exists in two forms that are of primary interest to us. One is the traditional gypsy moth, which is not the one in question here. The other is the Asian gypsy moth, which is a new species to Canada, an exotic species, a species for which we do not have a new substance in effect this country.
There really are only three ways humans can control a pest if you accept that we are part of the ecology out there and we have an interest in getting fuel and fibre from our trees. One is a physical method: you can actually go out and prune trees or take off the infected part. It's costly and it's time-consuming. The second one is a chemical approach that we've used since the war, and that has run into its own set of difficulties. The third one is a biological approach, which is what the Bt approach is. That's all there really is. If we are going to intervene we use one of those tools or a mixture of them.
Again, the question we face is one of costs and benefits. My sense is that there probably isn't any intervention we can make in nature that doesn't have a cost and a benefit. I guess the question is if we intervene at all, how do we maximize the benefits and minimize the costs?
My sense on the Asian gypsy moth is that this is a significant threat to the forest industry of Canada, which is a very big industry. If we want to intervene, how do we do it in the least disruptive method?
My sense of the issue just raised about traps is that traps are useful in identifying if in fact gypsy moths have come in, but they are insufficient to control or eradicate the disease. We will probably have to do something further. While I wouldn't suggest that there's any way to have a free lunch regarding the gypsy moth, the choices we have are either to try to keep it out, which is what we're doing, or if it gets in, to live with it, try to control it, or try to eradicate it. Very likely any intervention will have some costs and some benefits.
Thank you, Chairman.
The Chairman: Thank you.
Mr. Adams.
Mr. Adams (Peterborough): Gentlemen, we really appreciated your presentation. The chair has already commented on the fact that you kept to time, you were clear, and you addressed a very wide range of issues.
Our committee has dealt with this matter before, but you gave us a good overview of the extent to which this topic permeates our society today and the extent to which it includes quite passive interventions with the system and then quite aggressive interventions with nature. I think it's a matter about which there's great public concern.
The figure of 25% of the economy struck me because I hadn't thought of it in that way, but I think the general public believes that biotechnology, whatever it is, is now permeating our society in all sorts of ways, I think rightly.
The chair mentioned that we heard, and I'm sure you did as well, the radio clips this morning from this conference that's going on here. I believe it's called the Codex conference and it's the World Health Organization in Ottawa. It's a nice coincidence.
They didn't use an example to show that biotechnology would result in less use of herbicides, less use of pesticides, or anything like that. The example I heard was of a tomato with hog protein. The media used that rather than the other example, which is reduced use of chemical controls in agriculture, because of the implications of that.
The implication of that is not an improved tomato from a health point of view, it's a tomato that has four vestigial legs. I think they used it so that I and other people would listen to it. That is feeding into the public perception of the topic that you have gone to these great lengths to discuss with us, and it's something that governments are grappling with.
Why is it that, as we heard on the radio this morning, most of the countries represented at that conference are wary of labelling biotechnology products? Can you discuss that? Why do you think it is that nations are wary at the moment of labelling biotechnology products in some way?
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Mr. Buccini: Perhaps I can start and give a few impressions, but I think my colleagues from Agriculture and Agri-Food will have some remarks as well.
The example you gave us this morning, the tomato with four legs, so to speak, is a bit of a classic and really attracts public attention. I think the area of food is one that is quite sensitive with regard to consumers, particularly persons with allergies.
The notion of being able to walk into any food or vegetable store and pick up a tomato and accept that the tomato today is the tomato of ten years ago is one thing. But if we start cutting and splicing particular genes into those products, then persons who have peanut allergies or certain protein allergies may have to concern themselves about whether today's tomato in fact may not be what he or she was used to acquiring. I think the foods area is one of the most sensitive areas.
As Dr. Morrissey and Dr. Bailey pointed out earlier, biotechnology processes themselves aren't new; it is these particular gene-splicing approaches that are the newest of it and the ones that really attract the most heat.
Perhaps Keith Bailey could get on this one to help you out.
Dr. Bailey: I agree with what my colleague has said. This is one of these issues where I think the traditional biotechnology approach is what we have discussed, where there have been random introduction and interaction of many genes. In fact, the public has accepted hybrid crosses of all kinds with little thought as to whether or not this could be damaging.
I suppose I want to come right to the bottom line. The four-legged tomato is damage to me because I am eating something that is biotechnologically constructed. Something strange may have happened to the genes of this material, and that could have implications for my health.
The fact is that people are eating tomatoes with their pork. They are eating all kinds of genes from pigs, tomatoes, and so on all the time.
What has happened in the past when breeding took place within species of course was a big, random mix-up in which nobody really knew - we don't know now - what had happened to these genes, what the potential effects could be for the switching on and off of different genes within the modified breed, variety, or whatever it would be. Here we have a much more specific and controlled situation and we can actually identify what has happened.
To come back to your earlier question on why there might be such concern on labelling, I suspect it is because it would somehow suddenly highlight a change that, as far as one can tell, with the best knowledge we have at present, doesn't mean that a very specific or dramatic change has occurred in this product.
Nevertheless, with the great move toward public consultation, with which I think everyone is very much in agreement... For example, strawberries resistant to frost damage: people by and large accept that the genetic change to protect strawberries is a very good one.
The keying in by media is something that attracts attention that could be problematic. I suspect this is why there is such debate on how to approach this so we all will have the wisest decision on making this information available.
Mr. Adams: You've given us the figures for the growth in different sectors of it. In a few years someone is going to appear before a committee such as this and say that it's 75% of the economy.
The point is that, with respect to labelling, society is trying to catch up with this and to cope with it. Would that be your interpretation?
Dr. Bailey: Yes, I agree.
Mr. Deacon: I think my other two colleagues would like to comment on this important issue, if that's okay, Mr. Chairman.
Dr. Morrissey: Listening to the conversation, I sense that we should go back to first principles. Mankind can intervene in a physical, chemical, or biological way. My sense is that in any of those three ways we can do good or we can do harm. Now that biotechnology has come to the forefront of the debate, you sense that we may have the power only to do harm in biotechnology. My sense is that it's no different from any of the others. Our interventions can be positive or they can be negative. The stuggle would probably be the same as that with any other intervention: how can we, from a human point of view, maximize our benefits and minimize the cost to society and to nature?
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A second little comment is that I think we need to differentiate in our minds between the type of biotechnology we're speaking of. The type of biotechnology that probably is most controversial is the tomato example, where you cross species. There's a great deal of the new biotechnology going on, which is really non-controversial. You move a gene from one pea plant into another pea plant. It really is this subset that probably is controversial.
We in fact have been crossing species in the past using traditional technology. For example, triticale is a product of crossing oats and wheat. That was done before the newer biotech.
A specific last comment, Mr. Adams, on why people may be worried about labelling. One thought is that wheat, for example, is mixed about 15 times before it's baked. If there were to be specific labelling of new biotech versus traditional, then you'd need dual production systems, transportation systems and processing systems, which is costly.
The second one is another practical difficulty. I've read that corn has now become so widely used, soya perhaps even more so, that if there are 10,000 products on a grocery shelf, probably 2,000 of them contain fractions of corn. At what stage do you stop labelling on the fractions once you've gone past the primary corn itself?
The last two comments are the perception of natural versus unnatural. If you put a label on that differentiates something as being sufficiently different that you would require this increased cost and this increased information, then it might imply that this product is natural in some way but the other product is unnatural. It might in a similar way give a connotation of safe versus unsafe, because the primary reason Health Canada, as I understand it, requires labelling is if there's a safety difference, if there's a condition or a warning that requires to be given.
Thank you, Mr. Chairman.
The Chairman: Mr. Walker.
Mr. Terry Walker (Team Coordinator, Biotechnology Directorate, Materials, Chemicals and Bio-Industries Branch, Department of Industry): Thank you, Mr. Chair. I'd just like to add one or two more comments to what the other respondents have said.
On the question of labelling, Dr. Morrissey clearly pointed out the difficulty labelling products that have come from what are known as commodity crops, such as wheat, canola and barley, which might go into beer. However, in the U.K., where they've been able to identify specific products that contain only a known genetically engineered biotechnology product, such as cheese containing genetically engineered chymosin, or alternatively, tomato purée made from Californian tomatoes that have been genetically engineered to ripen all at the same time, those products have in fact been labelled, and I believe have received wide public acceptance.
The Chairman: Thank you.
We now have Mr. Lincoln, followed by Mrs. Guay and Mrs. Kraft Sloan.
Mr. Lincoln (Lachine - Lac-Saint-Louis): Mr. Chairman, if I may, I'm going to ask my questions all at once.
First of all, Mr. Buccini - and you can answer later - I would like to know where we stand with the regulation that's in the works. What is going to be the scope of it, and the timing, and what is the process for it to be implemented?
In regard to a remark by Mr. Morrissey, that what we need is a predictable climate of safe and tough regulations so that investors are aware, before they start developing biogenetic products, of what they face, I think we would all agree with the predictable climate. The problem I think we all face here - and it's why we have so many questions about biotechnology - is that it's impossible to predict consequences in advance. The consequences are always far away in time, and nobody quite knows what's going to happen.
As an example - and I'm not talking about biotechnology per se - at one time DDT was considered to be safe. CFC gases were considered to be a great find. We used to use leaded gasoline and think it was just fine. Today we're questioning mercury in fillings in our teeth.
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It always happens after the event. We find out twenty years afterwards that we shouldn't have done it in the first place. I think that's why people are so wary.
I'm sure that when the British started their feedstocks for cattle, they never thought that the mad cow syndrome could happen.
BST is one example where I can assure you that a lot of us in the caucus have a tremendous reservation about whether we should introduce it into Canada and where there are tremendous pressures on behalf of government departments to introduce it.
This brings me to my second question to one of you. In the CEPA report we had suggested a strong involvement by CEPA in biotech notice and assessment. However, this was diluted, and now we come up with the principle of the safety net, which says that where legislation or regulations do not exist, CEPA will provide a general safety net to protect health and the environment.
It would be interesting to know how the different representatives here view the general safety net to protect health and the environment. Is it the current safety net of CEPA?
Where legislation exists and regulations respecting notification and product assessment to protect health and the environment are approved by the Governor in Council, CEPA would have no regulatory role.
I remember that in November of last year - I don't have the press release with me - the Minister of Agriculture and Agri-Food decided to turn the responsibility and authority for biogenetic products over to the industry itself. I think it was in connection with dairy genetics. I could be wrong; it could have been another, related field. This seems to be the trend today. We say that we can't regulate, so we leave the industry to self-regulate.
What happens in that case? Who is ultimately responsible? Is it CEPA, under the safety net? Is it the Minister of Health or the Minister of Agriculture? What happens in the specific case where the Minister of Agriculture has decided to turn his or her responsibility over to an industrial concern or a dairy association or a chicken feed association, or whatever, to control itself in regard to biogenetic products?
Mr. Buccini: I believe Mr. Lincoln's first question pertained to the current status of the regulations under CEPA. I'll answer that question.
The regulations are at present with the Privy Council Office of Justice undergoing what I believe are the final drafting steps. Subject to the receipt of those regulations, they will be provided in due course to both the Minister of the Environment and the Minister of Health, as both ministers are jointly responsible under CEPA. Of course they will then go through the regular process for review and cabinet approval and publication in the Canada Gazette. I can't give you a firm indication of the timeframes once they are provided into the system, but we're expecting to get our regulations back very shortly.
Your other question was on the scope of the regulations. There are three component parts to this regulation. One is dealing with biochemical products, such as enzymes or biopolymers. These are non-living or inanimate products of biotechnology. The second one would be for micro-organisms. As I mentioned earlier in my remarks, these tend to be the kinds of products that are most widely used in bioremediation, biomining, and bioleeching types of applications. A third category would be other organisms. I believe it's just a general statement. That would provide in essence the safety net approach.
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Mr. Lincoln, have I responded well enough to your questions?
Mr. Lincoln: I think that's fair enough. When you say ``shortly'' you're talking about what, one month, two months?
Mr. Buccini: Oh, hope springs eternal. I would hope that within the next month or so we'd see them back. They've been with Justice for some time now.
Mr. Lincoln: Can you tell me about the third section, ``Other Organisms''? Is it a blanket type of category?
Mr. Buccini: The intention is that it would be non-specified to include any type of organism. Consistent with the safety net approach, which I discussed and which I think you also alluded to in your remarks, to the extent that other federal acts and regulations do not cover these products, CEPA will pick them up.
Is that sufficient?
Mr. Lincoln: Yes, thank you.
The Chairman: Are there any other comments?
Dr. Morrissey: Yes, Mr. Chairman.
Mr. Lincoln raised the issue of predictable lulls. If I could just cite Churchill for a moment, he said that prediction is difficult, especially about the future. I think we'd probably all agree.
What I think may be possible is that some of the principles underlying the lull can be quite predictable and quite durable. For example, back when this country was first formed in the late 1800s, Health and Agriculture and other departments were given pieces of legislation to ensure that those new animal and vegetable things that were either imported into this country or created in this country were safe, pure, potent, and efficacious.
That legislation really hasn't changed significantly over the last 100 years. It has served us in the sense that whether those products, such as a new animal vaccine or a new human vaccine - human is part of the animal kingdom - are produced by traditional means or by new means, the technology has changed and the process has changed, but the control of the product hasn't changed. It must still be safe, pure, potent, and efficacious.
There was another comment that I think might be worth mentioning, and again it's back to first principles. Mr. Lincoln, I think you're perfectly right that we can't predict the future about DDT. I think you're perfectly right that there were unknowns back in the 1940s when DDT was first introduced in a significant level.
If you go back to the scientific method, which is the basis for informed decision-making in this area, the assumptions underlying the scientific method are observation, physical explanation, parsimony of calls, and approximate truth and correction, which is the important one. Because we don't know the future, because we don't know what we don't know, the most we can ever claim, no matter how clever we think we are, is approximate truth and correction.
In DDT's case we made an approximate truth. We said based on the best knowledge available we're now making a decision. When new knowledge became available we had to make a new decision, a correction. We had to admit that we were wrong and back-pedal.
I have a third point on the CEPA regulations and the Ag Canada regulations. At the working level we have agreed on the information requirements to ensure that new substances, animal or vegetable, released into the ecology or into the environment are safe, pure, potent, and efficacious. Hopefully we can go forward in tandem with the two sets of regulations, the safety net and the line departments, requiring essentially the same information.
On the last item, the turning over of control of the biotech file to the dairy industry, I'm not aware of this. Do you have further detail, Mr. Lincoln?
Mr. Lincoln: As I said, I'm not sure if it was the dairy industry, but I will try to trace it. There was a press release by the minister in November of last year turning over the responsibility for certain biotechnology sectors. I don't know whether it was a dairy industry or whether it was a part of some other agricultural institution. I will find it for you because I would be very interested to know. It was some sort of delegation of authority. I was asking the chairman if he remembered, and he did remember, but I don't have the document with me. It's in my office. I wish I did have it.
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The Chairman: We're searching for it right now.
Mr. Lincoln: Maybe before the end of the session you could let me know.
Are you contemplating any such delegations in the future? Where do we stand in regard to this?
Dr. Morrissey: Mr. Lincoln, I'm not aware of any delegation of biotechnology powers to the dairy industry. If the data becomes available I'd be happy to look into it.
The only comment I would make is in whatever regulatory area any of the line ministers were involved, if they have acts of Parliament that hold them responsible for the safety, purity, potency and efficacy of animal or vegetable products released into the environment, while they might delegate the administration of the file to, for example, public servants or anybody else, they really cannot delegate the responsibility Parliament has given them.
Mr. Lincoln: Thank you for that.
Could you just comment briefly on BST, where it's at, whether you or the representative from Health are in the process of re-examining it. Have we shelved it for good? Where it is at?
The Chairman: A brief comment, please.
Dr. Morrissey: Health Canada requested the manufacturing companies to submit further data on animal health several months ago. The final decision by Health Canada hasn't been made, and it's not public knowledge whether or not the data has been submitted yet. So no decision at the present time.
The Chairman: Thank you, Mr Lincoln.
Madame Guay, Madame Kraft Sloan, followed by the chair.
[Translation]
Ms Guay (Laurentides): I would like to discuss briefly the issue of bovine somatotropin because I believe that this is a very important topic.
We know that this hormone, which is injected into cows, enables them to produce more milk more quickly. Earlier, we discussed the labelling of products which supposedly contained certain hormones. As a consumer, when I buy a pint of milk, I would really like to know whether or not the milk was produced by using a hormone. Consumers are entitled to know what they are consuming, to know whether or not a product is natural. Moreover, we do this today, but we must ensure that we continue to do this. This is a commitment that we must be making to our consumers, to the citizens.
Secondly, we have noted that the definition of biotechnology varies tremendously from one department to the next. It reminds me a bit about sustainable development; we each have our own definition but we're going to have to come to an agreement and establish one definition, not ten.
I believe that the Department of the Environment has a very comprehensive definition of biotechnology and that the other departments should adjust their definitions accordingly. The more progress we make in technology, the more products, by-products, hormones, etc. we will have. The field is becoming very big and very broad. We have to pay strict attention because we could use a product and inject a hormone such as somatotropin only to discover, 20 years down the road, that it is carcinogenic or that it has some other harmful effect.
I feel that we must proceed very cautiously and I would like to know whether the different departments are willing to accept a definition which, according to us, the members of the Standing Committee on the Environment and Sustainable Development, is very precise and is aimed at protecting people.
Are the various departments willing to make any efforts in this regard, more specifically the Department of Health and the Department of Agriculture and Agro-food?
People are entitled to know what is contained in the products they buy and consume. I would like to hear your views on this matter.
[English]
Mr. Deacon: Perhaps I could make one comment. I think departments are working very closely together on definitional issues and cooperation in drawing together the various aspects of the regulatory side.
Perhaps Dr. Morrissey would like to speak specifically on the BST issue.
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[Translation]
Mr. Morrissey: In my opinion, we all agree on the definition of biotechnology, namely the definition that I gave you this morning and which is contained in CEPA. I don't think that there is any conflict as far as the definition is concerned.
As for the labelling of biotechnology products, and in the specific case of bovine somatotropin, I believe that we have to look at two aspects of this issue. Is the product acceptable health-wise according to the Department of Health? If so, as I read it, the company will not be obliged to put a special health label on the product.
From the perspective of consumer information, our current legislation - and I'm not saying that it could not be changed - regardless of whether it comes from the Department of Agriculture and Agro-food or from the Department of Health, requires that the label be real and honest. In English, we say that it must not be false or misleading. In this case, providing that the label is not misleading or false, there is no obligation to add anything else.
The second aspect of the issue is purely a question of feasibility, a technical problem. As far as I know, right now we do not have any tests that can differentiate between naturally occurring somatotropin in milk and somatotropin that has been artificially added by man.
Ms Guay: If I understood you correctly, if bovine somatotropin is injected, there's no obligation to indicate this on a label or to inform the public. This is terrible. As a consumer, when I buy a pint of milk, I would really like to know whether or not a hormone has been injected into the cow so that I can have a choice and buy either a natural product or a product with added hormones. You're telling me that this does not have to be stated. That is really terrible.
The Chairman: Thank you, Ms Guay.
Ms Kraft Sloan, followed by Mr. Knutson.
[English]
Mrs. Kraft Sloan (York - Simcoe): Actually, from what I understood about somatotropin, you can add a tracer to it. You might not be able to detect between the two different types, but you can actually add a tracer to it and therefore identify if BST has been added to the milk - or injected into the cows.
At any rate, my question was about labelling as well. There is a growing incidence of allergies among adults as well as children. One of the most deadly forms of allergies, especially in small children, is the allergy to certain kinds of nuts. I've heard of a situation where DNA was taken from Brazil nuts to manufacture tofu or soya products. An individual who had a nut reaction had consumed some of this product and had a very adverse reaction.
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So while a substance may not seem toxic or seem harmful to human health in most situations, if an individual has severe allergies, they can be adversely affected. We also have nutritional labelling. So I'm having difficulty in understanding why there are so many obstacles to labelling.
The other point on labelling that I'd like to make is that if biotechnology is going to become so pervasive in our daily lives, then I guess the public is going to have to develop a comfort with it and attitudes are going to have to change. So public perception around this is going to have to change.
From what I understand, they're allowing negative labelling in the United States around rBST.
I wonder if you could comment on some of the things I've said.
Dr. Bailey: If I could perhaps start with the last of your remarks, respecting the level of comfort and the public interest here, I believe you are perfectly correct. Public confidence possibly would not be restored if the whole issue of labelling were not investigated very thoroughly, which is perhaps why at the moment Canada is looking very carefully at what is going on at the current convention, which is indeed examining the whole issue of labelling and how best to move this forward.
Referring to one of the questions from one of your colleagues earlier on labelling and if the words ``biotechnology produced'' were to appear on the label, it does sound rather like an informed consent type of label, as if there was an informed consent to some issue of concern.
Certainly Health Canada looks at all of the products that are produced by genetic engineering, as we described earlier for the novel foods, and how they are evaluated and how they should be labelled becomes part of that evaluation. So the advice of the committee, as well as the public consultations the departments are now holding, is most useful to driving this forward.
With respect to your colleague's earlier questions about labelling, as Dr. Morrissey pointed out, it is essentially impossible to know whether a hormone found in milk is derived, as you might say, naturally from within the cow, because it is in fact the same hormone that is given to the animal. You could not differentiate among them.
However, as Dr. Morrissey also pointed out, it is essential that we continuously monitor the state, using the knowledge we have today to make the best judgments for the times, and, as we develop further knowledge, to revisit whole issues. This is continuously done by departments. It's certainly done within the Department of Health - for example, in the drug area, where new products are introduced into the market with the best knowledge we have at the time. We believe not only that they're safe and efficacious, but also that they will be effective and efficient in the population.
It depends upon looking at broad populations in the future, perhaps many thousands or tens of thousands or hundreds of thousands of patients across many years, before the whole value of the introduced medication can be assessed. It will be the same in many areas, I think, including the whole biotechnology area.
Mrs. Kraft Sloan: And can a tracer be added or not?
Dr. Bailey: It could be. As my colleague was -
Mrs. Kraft Sloan: What is the difficulty in that? If we're talking about a statement, you have a statement in here that talks about an environment for biotechnology and how that's where the money is going to flow. These are all based on free-market principles. One of the most important principles of the free market is access to information and that people have equal access. I learned that in Finance 101. That's how markets work. If there is not equal access to information, then you're not going to have a free-market situation, so consumers are not going to be able to make decisions. If these products are good, then consumers will have no problem with using them.
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If you can add a tracer to this, then you're going to be able to differentiate between two types of milk, one that has rBST added and one that doesn't have it. The fact that it's naturally occurring in the milk is one thing, but when you oversubscribe to a certain kind of naturally occurring substance, it does have an effect. But that's another issue. This is really talking a lot about the free market, so if you're going to have it, you have to have it all the way. So what's the problem?
Dr. Bailey: Perhaps I'll turn first to the issue of adding a tracer. As my colleague was mentioning to me, one in fact could be perceived as being in a worse situation by adding a tracer, inasmuch as an additional foreign material is introduced.
I remember some years ago - and I'm sure my colleagues do too - when the issue of adding various antimicrobial, antibacterial agents to milk came up. With mastitis, and with penicillins being added, there was a lot of discussion about adding a tracer to ensure whether farmers were using this and to ensure what the length of time coming from the farm gate was.
One of the ideas there was to actually introduce a dye - I think at the time it was a brilliant blue - to determine whether or not there was any trace of the blueness to act as a tracer for the antibiotic. It was in fact rejected because of the blue, rather than because of the antibiotic.
Once again, on the issue of public knowledge and having full information available, I do believe departments are learning very rapidly that this is very important, and the mechanism of being able to do this is possibly one of the more difficult things to address.
Mrs. Kraft Sloan: It's one of the issues that I raised around allergies. If a product or process is tested and found to be benign or not harmful to human health, but people who have allergies consume it because they think they're buying one food product when in fact they're buying another food product, one that was developed through a biotechnological process, it is going to affect them adversely in terms of human health. So on that kind of justification, there should be labelling.
Dr. Bailey: Mr. Chairman, I believe that further hearings of this committee will be able to delve into some detail with our colleagues from the departments on specific regulatory aspects.
As I understand it, within the food directorate at least, with the new products coming forward, the evaluation of those products would include the possibility of adverse effects, including the liability to increase the chance of allergic reaction.
I found the specific instance you gave rather fascinating. I would have to look into it and see what occurred there. I believe you mentioned genes from Brazil nuts being introduced into tofu and the possibility of a reaction there. One does continually hear about instances of this type that, on investigation, may be shown not to be related to the consumption of such an article.
It poses quite interesting scientific challenges, but of course as far as the consumer is concerned it's a safety challenge. And I believe that is the one the Department of Health faces today.
Mrs. Kraft Sloan: Yes.
The Chairman: Thank you.
Dr. Morrissey, do you want to make a comment?
Dr. Morrissey: Mr. Chairman, if I could go back to the allergy question, speaking for agriculture, if that product - and I understand it was taken from the Brazil nut and incorporated into domestic product in North America - were included in an animal feed, we would go back to first principles.
First principles say that the feed must be safe, pure, potent, and efficacious. If the feed were found to be unsafe, it would be taken off the market. If it were found to be something less than unsafe, but something different from perfectly safe, then a label could be put on, as happens with pesticides or with any other registered product where a precaution is put on the label.
On the question of BST and whether negative labelling could be allowed in this country, negative labelling is always allowed in this country because the principle is that the label must not be false or misleading.
Negative labelling would say something like ``This milk was produced by cows that have not been treated with rBST''. As long as that statement can be shown to be true and not misleading, anybody in the country could put it on, just as they do in the United States.
The Chairman: Thank you. Mr. Knutson, please.
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Mr. Knutson (Elgin - Norfolk): Dr. Morrissey, I want to take you back to the comment you quoted from Churchill, we don't know what we don't know. You went on to talk about the scientific method. If I can paraphrase, your basic message was everything is a calculated risk. I want to ask you a question that goes to the fundamental issue. What's an acceptable calculated risk and what isn't an acceptable calculated risk often depends on who's doing the calculation and what their motivation is.
The issue I see, from an agrifood perspective - and I come from a heavily agricultural riding - is a strong motivation for biotechnology. It helps them produce their products, makes them more profitable, creates a stronger market for exports, improves their cashflow, improves their net bottom line and generally creates a higher level of prosperity for the individual and the community at large.
Given a capitalist system, the commercial imperative is the dominant one. People basically are in business to make money. Contrast that with a strict environmental perspective, where the public good is measured quite differently from making money. A staunch environmentalist would see the profit motive as a necessary evil; it's not something to be lauded particularly.
I want to get your perspective on who should be doing the measuring, the controlling and the regulating. Given the numerous failures of industry or the general capitalist system, whether it was... Sometimes people may have acted in good faith and sometimes they may not have acted in good faith when they've allowed new products into the marketplace. Sometimes they acted in good faith from the point of view of maximizing shareholder value but not from a public interest point of view.
Who ultimately do you think should have control over this and to what degree?
Dr. Morrissey: My sense of the essence of the question, if I could feed back to you, Mr. Knutson, is the issue of the agricultural community making decisions or the environmental community making decisions. To put it another way, how do you get the appropriate balance between sustainable and development, sustainable being environmental sensitivity and development being economic return and wealth generation?
Mr. Knutson: Recognizing that anyone with a commercial interest sets up an initial bias.
Dr. Morrissey: May I say anybody who has no interest is disinterested and has another bias.
Mr. Knutson: I'm not sure that holds as strongly.
Dr. Morrissey: My sense is it isn't an either/or issue. If you go with either sustainability or development, you have an unbalanced equation.
The Chairman: Excuse me for interrupting here, but in both cases you still have public health concerns, don't you?
Dr. Morrissey: Yes.
The Chairman: So the image of a balance that you are painting is really one we cannot accept, the balance between sustainability on the one hand and development on the other.
Dr. Morrissey: Perhaps then I could try to tackle the question from another point of view.
The sense I got from the question was that in agriculture there might not be a sensitivity to the environment since there is a requirement to make a living from the soil. My sense is there's some truth in the comment. However, I would leave with you the thought that the term ``stewardship of the soil'' was coined by the agricultural community. It was coined because they realized they weren't in it simply for a job; they were in it for generation over generation as a way of life.
In western Canada we damaged the environment. With the mould-board plow and a little help from nature - we had dry years - we turned the west into a dust bowl. We had to go back and rehabilitate the west.
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One of the items Mr. Clifford raised was that we couldn't predict the outcome of things we'd done, and when we made a mistake we had to admit it and go back and correct it.
Mr. Knutson: On that point, are we doing okay in terms of topsoil?
Dr. Morrissey: Yes, we are. We had reduced the fertility in the west up to the mid-1970s, but we have improved it from the mid-1970s on.
The other little comment I'd make is that in agriculture we simply are one piece of biology. If you will look at the literature on agriculture, you'll find that about 70% of the research money in agriculture around the world is spent on sustainability, not on development. That's simply because we can't get out of being part of nature. For example, the wheat varieties we developed in the 1920s, which were resistant to rust, became susceptible to rust when nature started to defend itself and found new ways to attack it.
So, again, we spend about 70% of our money on simply trying to maintain the bread we've put on the table in the past.
Mr. Knutson: From the perspective of looking at the family farm, I don't disagree. Generally these people care about the land and they're stewards. Certainly their motivation is fine. But once you move beyond the family farm and get further down the production chain, I'm not confident that the long-term view always prevails.
You would think that a logging company or somebody in the logging business would have an appropriate appreciation for not destroying all the forests, yet if you take the Ottawa Valley, this was at one time one of the prime logging areas in the country, but now we have no more trees. We don't have any serious logging in Ontario at all.
Capitalism is flush with examples of where people take the short-term view in order to maximize profits in the short term, notwithstanding that there's a serious problem with the general public interest, whether in the short term or in the long term.
I'm just saying that if we take that latter point of view, then from a government policy-making point of view we will probably end up with fairly strict, or at least stricter, environmental regulation of new technologies.
Dr. Morrissey: My sense on the last comment is that it might be useful to make a differentiation between a farm or property that is privately owned, where there's a vested interest to maintain its value, and property that's publicly owned, where what the economists call ``the tragedy of the commons'' comes into play. For example, if a fish stock is publicly owned, I don't own my piece of it, so I don't have the same incentive to preserve my property to pass on to future generations. My sense of the comment on the forests may in fact fall into that category.
There's a differentiation between privately held property, such as a farm - and almost all farmland in Canada is held in private farms -
Mr. Knutson: To make another distinction, though, what about the way in which corporations behave?
I don't mean to be trivial, but I'll take an example of corporate decision-making that clearly wasn't in the public interest. The most classic case taught in business schools is where the Ford Motor Company put out a car called the Pinto. Eventually they found out it had problems with the gas tank. They did a calculation of how much it would cost to recall it and how much it would cost to fight off the lawsuits from the people who died in the fires caused by the gas tanks. They did a calculation, and it turned out it would cost them less money to allow the accidents to go ahead and deal with the lawsuits than it would to recall the car.
I don't know if that ethic is different in any other business. They made the decision, from their point of view, that would maximize value to their shareholders.
My point is that corporations make decisions that maximize value to their shareholders that in no way, shape, or form necessarily comply with a long-term view towards the environment unless governments make them, unless we say ``You have to do this because we're going to make you do it''.
While governments have an interest in fostering biotechnology and innovation in the agrifood industry, to me it's a matter of striking a balance. I go back to my original point as to what principles would apply, given that everything is a calculated risk and it depends on who does the calculation.
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Dr. Bailey: I can't answer the question. I think it's a very difficult one. I can think of an example that governments themselves face in the transportation industry.
Not to throw this discussion too wide, Mr. Chairman, but consider the amounts of moneys to be put into roads, for example. One could decide that we're going to build a bridge at $100 million and that will save so many lives. These calculations unfortunately do have to be done, and the numbers that are derived by different agencies will not always be the same. The hospitals have to make decisions and transport does. You've posed such a tough question and I don't know how one really drives at the answer.
Mr. Deacon: I have a very quick comment. One of the observations I've had from the interdepartmental process we have in the area of biotechnology is that one advantage of that process is that it does stimulate debate between departments with varying points of view. As these issues arise, the process we are currently using does bring these different points of view to the table. You're quite correct that it's a question of balancing between very major competing interests, but at least those are brought into the equation. I think that's where it's noted.
The Chairman: Thank you.
Mr. Knutson, you have raised some pretty interesting questions here, but time is a tyrant. We have to leave this room for another committee fairly soon. There are four members who want to ask questions on the second round and on the first round there are still Mr. Finlay and myself.
Mr. Finlay.
Mr. Finlay (Oxford): It's been a most interesting morning and I apologize for not being here right at the start, but I was downstairs.
I want to echo a little bit what Madame Guay and Karen Kraft Sloan said about labelling and the public's right to know. I'm particularly interested in what Mr. Knutson said because it was what was running through my mind.
We've just had a two-day forum on jobs and sustainable development, and one of the statements that appeared in one of our briefing notes was that if everyone in the world was going to live in the manner we do in North America, it would take two more planets to provide the sustenance and the energy and the food for five billion or six billion people. It seems to me that is sort of what Mr. Knutson has been saying.
I take most of your answers, particularly those of Dr. Morrissey, and I don't quarrel with you. It seems to me that safe, pure, potent, and efficacious are fine guideposts except that with many things in the biotechnology field it's going to take 10 or 15 or 20 years before we could possibly know whether it's going to be safe. It may pure, it may do the job, but with that job what we don't know is what other effects it will have.
We know the number of amphibians is way down. We know there's a build-up of non-biodegradable and persistent toxics in the Arctic. We know there's a similar build-up in the Great Lakes. We want to try to do something about it, but we certainly don't know whether we're going to be successful or just how much reduction in harmful pollution it's going to take to stabilize. We don't really seem to be able to do it even for greenhouse gases and carbon dioxide and climate warming, even though we have agreed internationally to reach a certain level of reduction by the year 2000.
I guess your answers boil down to something that maybe we have to accept as human beings; there's a risk in whatever we do. At what level is that risk acceptable and at what level is it not? If we add a very large dollop of the precautionary principle, and in the economic sphere and in the business sphere we add a large dollop of liability, as we've seen companies have to pay in the past - Gar mentioned the gas tanks, and I think breast implants and thalidomide are a couple of other good examples - perhaps we'll be able to move forward as rapidly as we're going to be able to without building in total disaster.
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I like your comment about the roads, Mr. Bailey, because I was thinking of that.
I'm encouraged, Dr. Morrissey, that you say we've improved the fertility of the west. I read somewhere that if I got to the top of the CN tower I could see 37% of the first-class agricultural land in Canada and 23% of the second-class agricultural land in Canada, and I have to tell you, most of it's covered with roads and houses and factories.
We don't do the things we should do to maintain the quality of life. We do things on a very ad hoc and short-term basis, unfortunately, a lot of the time.
The Chairman: Could we have some succinct comments, please?
Dr. Bailey: I'll keep them succinct if I can, Mr. Chairman. I didn't mention in my presentation the research arm, except to merely mention it and not pursue it. At the time of the introduction of the national biotechnology strategy, some 12 or 13 years ago now, I suppose, research was one of the key components. I do believe the continuous support of the national biotechnology strategy in the research direction will help us deal with some of these very vital issues Mr. Finlay has raised.
I would perhaps say that should we be looking into not only methods, if we can, of determining absolute risk, but also research into the public's perception of that risk and how the information comes forward to the public in understandable ways.
The Chairman: We have now the second round. I will try to compress my questions as quickly as I can.
Mr. Buccini, could we have your comments on whether the precautionary principle is adequately served in the reply by the government to our CEPA report?
Mr. Buccini: I'm hesitating here, Mr. Caccia, because precautionary principle has different meanings for different people. I just have to be clear what interpretation is in your mind.
Precautionary principle, as I use it, is the one that derives from, I think, principle 15 of the UNCED document in 1992, which basically speaks to the absence of the last bit of information, if I may paraphrase. It's not a basis to not take a decision.
The Chairman: I want to take as a benchmark the precautionary principle as defined in our report, and concentrate on that.
Mr. Buccini: Okay. The government's response does attempt to implement the precautionary principle. The notion is there that under the new substances provisions of CEPA we would want, for those products subject to CEPA, the submission by industry of information sufficient to determine potential risks to human health or to the environment. The draft regulations, in response to Mr. Lincoln's question, I alluded to will, I believe, provide us with that framework to get the information so that we can review products prior to their market introduction.
So I feel that the regulations will probably be where you'll be able to assess the adequacy of how well we are meeting your precautionary principle.
Is that what you were getting at, sir?
The Chairman: Yes, I was indeed. As to what is not there - in your reply you refer to what is not there - how would you comment on that?
Mr. Buccini: I'm sorry, sir, I don't understand what you're referring to as not being there.
The Chairman: Those aspects of biotechnology that are not covered under CEPA.
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Mr. Buccini: As I believe Dr. Morrissey alluded to in his comments earlier, there is the prospect of having what I might call sectoral acts such as those Dr. Morrissey referred to - the seeds, feeds, fertilizers, health of plants and animals acts. We have been working with staff in his department for at least a year now, or perhaps a bit longer. Very similar provisions to those required by CEPA are envisioned as being reflected now within the proposals for regulations under the Agriculture Canada acts.
I think the CEPA proposals for regulations for new products of biotechnology will provide, if I can use the term, a template, which other departments are attempting to reflect within their regulations. So I think with the safety net and the residual nature of the act we are having influence beyond those products, strictly speaking, that will be notified under CEPA.
The Chairman: In this four-pronged departmental approach, which one would ultimately prevail in the case of dissent?
Mr. Buccini: It is a question of law as opposed to a question of which would prevail. My understanding is that as long as a product is required to be notified, for example, under the Seeds Act, then this is where it will be notified.
The evaluation it will be given there, as Dr. Morrissey has indicated earlier in his comments, would take into account the issues of safety, purity and potency. In principle, if this set of regulations goes through, what we'd be looking at is the same job being done, if I can put it this way, whether it's being done by a staff member within Agriculture Canada or Health Canada or Environment Canada. This would be the ideal situation.
The Chairman: Thank you.
My visual impression this morning, and it is only a visual impression, is that in your delegation here, one department is represented by two officials and the others by only one. I would be inclined to conclude that somehow Industry Canada has a lead role in biotechnology. Am I wrong?
Mr. Deacon: I think Industry Canada has a coordinating role, but the responsibilities, as said earlier, rest with the specific departments. We very clearly have a coordinating role and a lead role in terms of representation of the issue, overall, externally to Canada. But we work very closely with our colleagues.
The Chairman: Can you tell this committee why the coordinating role was given to Industry and not to Health or Agriculture or Environment?
Dr. Bailey: If I may, Mr. Chairman, I think I can probably recollect the events of the early 1980s when the national biotechnology strategy was being introduced.
Following a report to the federal government on biotechnology in Canada, it was decided that this fund should be launched. And it was the Minister of Industry, Science and Technology who was given the lead in that. In fact, the national biotechnology advisory committee reports to the Minister of Industry.
Dr. Morrissey: Thank you, Mr. Chairman.
If I could perhaps add to what Dr. Bailey has just said, my recollection was that the Ministry of State for Science and Technology, when it existed, had the legal mandate to coordinate the processes of science that cut across the mandates of an individual ministry. When the Ministry of State for Science and Technology was disbanded, the mandate for coordinating pieces that didn't fit elsewhere was incorporated into the mandate of Industry Canada. So, in the case of biotechnology, because it's a cross-cutting, processed technology rather than a finished product, because it is a tool that's used by seven or eight departments and because we're organized by product - agriculture, fish, food - somebody had to coordinate the process we were all using.
The Chairman: By the same logic, it could have been another department. Yes or no?
Dr. Morrissey: Yes, I'm sure it could have.
The Chairman: Thank you.
I have one final question. I don't want to hold up my colleagues, but it disturbs me. Very briefly, I see an apparent contradiction, which may not be there. On page 4 of your paper, Dr. Morrissey, you stated that:
- It is for this reason that the Canadian regulatory system is said to regulate the product and not the
process.
- The review process for biological drugs is especially thorough because it involves a review of
the process of manufacture, not just the final product.
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Dr. Bailey: Mr. Chairman, thank you. I don't believe there is a contradiction. In fact in the case of biological drugs the process often does define the product. The product is specific in its production by a biological means such as a vaccine, by the more traditional biotechnologies of the past, or by a new biotechnology product. This process is a very important one. It is reviewed very carefully to ensure the safety of the final product resulting from that process. So it's still product-oriented. It is the product that is approved.
The Chairman: Does this apply only to drugs?
Dr. Bailey: No, I don't believe it does.
The Chairman: Well then, why does Agriculture Canada state the Canadian regulatory system is said to regulate the product and not the process? Can you clarify that?
Dr. Morrissey: The acts in Canada, certainly the acts in agriculture, speak of notice to a minister of a product and information to a minister on this product. Very often the information on the product will, as my colleague has just indicated, provide information about steps in producing the product which may require oversight.
For example, in producing a vaccine, we wouldn't want the vaccine to escape into the outside environment. Those are the steps that come up in almost any regulated product. They come up, for example, with a product of biotechnology, and the issuance of a licence for contained trials and uncontained trials. So you're quite right, it's the product. But in producing the product, if there's a step that could be dangerous then this step is controlled.
The Chairman: Thank you very much.
On the second round we have Mr. Forseth, Madam Guay, Mr. Lincoln and Madam Kraft Sloan. Mr. Forseth.
Mr. Forseth: Thank you very much.
Earlier today we talked about labelling or in a general sense the right to know. Also, the presenters today talked about stakeholders' involvement. But I got the impression when this was mentioned the most important stakeholders, the public and the consumer and the citizens of Canada on whose behalf we're all supposed to be working, were not particularly seen as stakeholders.
It reflects back to this attitude Mr. Lincoln and Mr. Knutson talked about. We know best and it won't hurt you and we'll just proceed. We talked in the last few days in our forum about the ability of individuals to make right choices based perhaps on price - on not having perverse incentives - and also on an understanding of what best practices are. We have to be able to know to do right by the environment and ourselves. We need this information. I get a feeling here the old-fashioned dynamics of the old trends and pressures are operating now. We know best and let's fill a market niche and we'll find out the damage later. So I'm asking in a general sense, what have we learned?
It was also mentioned that there is a healthy tension between the various departments. There are discussions, and so on. In what part of this tension is the public involved? Is this a private ongoing interdepartmental turf war? Or is this process opened up so the public can have a bit of an understanding of how its money is being spent as these discussions unfold?
I'll bring it down to the specific example of having the right to know and being able to make a decision. I'll bring it back to the issue I talked about earlier about Btk spray. I want to ask specifically, what are the exact ingredients in the formulation of Btk spray? What is it in total and in what concentrations? In fact, what is used at the street level? What is actually sprayed?
The Chairman: Please give brief answers.
Dr. Morrissey: Thank you, Mr. Chairman. I'll try to answer the questions briefly in the order in which they were raised.
On the topic of consultation on labelling, all of the government departments worked together to hold public consultations in 1993. They followed up in 1995, then followed up with a consultation document leading into the Codex consultations at the international level.
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On the second comment, about experts knowing best, the point I tried to make earlier was that the lessons learned certainly since the war are that none of us know more than the approximate truth. Consider the level of humility we're all going to have to come forward with on any of these decisions, saying as Mr. Finlay has said that we simply do not know now what we may know in 20 years. In 20 years, we still won't know what we might know 20 years somewhere in the future.
On the last question, about Bt spray, I can't give an answer right now on what is the list of actives and inactives in Bt spray, but I'd be happy to get back to you, or perhaps contact our colleagues, if that's the source of the information.
The Chairman: Please do that.
Mr. Forseth: I hope that I'll receive a very good answer because I put this question on the Order Paper and I've been waiting for quite some time. I made a four-part question and I've received nothing but stonewalling as far as an answer.
The Chairman: Thank you. We will endeavour to get you a good answer. I'm sure Dr. Morrissey will do that.
Mr. Lincoln please.
Mr. Lincoln: Mr. Chairman, I thank my colleague, Madame Guay, for giving me her place, because I've got to go to another committee.
I would like to follow up briefly on what I said before about this business of delegation and also on what was said by my colleague, Mr. Knutson.
I've got to kind of state my bias very clearly. I'm 100% for the precautionary principle. I'm for the long term versus the short term. When we have any hesitation at all, I think we should be in favour of the environment and health above all economic biases.
In response to Dr. Morrissey, I agree that 20 years hence we will have to kind of make decisions about the next 20 years, but we won't know any better, except that the dangers and risks now are becoming so huge, as we have seen in so many cases, that I think we've got to be extra cautious, which brings me to my point.
In our CEPA review, on page 123, the Canadian Institute for Environmental Law and Policy said that if different laws continue to be applied to different biotechnology products, then all biotechnology products released into the environment should be evaluated with the same criteria and standards for public participation and available prevention options as in CEPA. They stated six criteria.
Evaluation has been the subject of what Mr. Buccini talked about very extensively in the framing of the regulations.
What I brought up earlier was this release from the Minister of Agriculture and Agri-Food on November 14, 1995. He said that we have committed $12.4 million in the next three years to the Canadian Dairy Network for dairy cattle, milk recording, and genetic evaluation. The CDN has been formed and is to take over the functions formerly operated by Agriculture and Agri-Food Canada. It will assume responsibility for all activities connected with dairy milk recording and genetic improvement.
The dairy industry highly values genetic improvement as a tool to compete favourably in the global marketplace. There was no mention of the environment or any other consideration. There's the transfer of dairy-related programs and AAFC's ongoing involvement in genetic improvement and evaluation programs for Canadian livestock.
Similar programs for beef, swine, sheep and dairy goats were successfully transferred in March 1995, when it was decided that the livestock industry would be better served if the programs were operated by industry. I know I'll be told probably that this relates to cross-breeding only.
Where do we go from cross-breeding to the alteration of genes? What about field trials? Are they covered by regulations today? I understand they are not. What kind of opening are we giving now when we say dairy cattle, milk recording, genetic evaluation, and what happens now when we are going to have the responsibility for the evaluation of the genetic improvement of beef, swine, sheep, and dairy goats?
What is the next step toward saying that the industry itself will decide whether it should evaluate the milk products and that some hormone is going to improve it?
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What kind of oversight, monitoring, recording and safety net do we have? Are we just kind of starting to go on a slippery slope? Isn't this what CIELAP was warning us against in very strong terms in our review? Is this why we're very worried about these multidisciplinary controls that become non-controls when we start ceding over a lot of our public good controls?
The Chairman: So now you will understand, Dr. Morrissey, why this committee became interested in biotechnology.
Dr. Morrissey: Thank you, Mr. Chairman and Mr. Lincoln.
I recognize the issue you've raised, which is the record of performance of dairy animals and pigs that was instituted after the war. It was basically government agents in the early days visiting pig farms and dairy farms on a spot-check basis to measure the amount of milk actually given by individual cows so that the claims of which cows gave most milk and which ones didn't, could be verified.
It's exactly the same with swine. They visited swine farms to physically weigh pigs at intervals to determine if claims that some pigs were genetically superior and gaining weight were in fact true. So it's the actual visiting of farms to measure and weigh that has been transferred, not anything to do with genetic breeding or biotechnology.
Mr. Lincoln: Excuse me, Dr. Morrissey, I can believe things that you say. At the same time, I have to be a skeptic.
That's not what I read. It talks about genetic improvement. It talks of Canadian exports of dairy embryos, semen and pure-bred animals in that same... Surely that's not just visiting to find out the weight of milk. If it talks about genetic improvement, surely that means something. It means cross-breeding and the improvement of embryos and the stock. Surely genetic improvement doesn't mean what you're replying to me, otherwise I'm more stupid than I think I am.
Dr. Morrissey: Mr. Lincoln is perfectly right. The information that is generated from weighing individual animals to see how much of an increase in weight a pig has had or how much of an increase in milk production a cow has had is used by the artificial insemination industry and embryo transfer industry to decide on which bulls or which pig sires they would keep. It's based on the performance of the daughters and offspring in the field. So you're perfectly right that this is what the information is used for, but what's been transferred is the actually visiting of farms and physically doing the measurements.
Mr. Lincoln: Are you saying then that there's no possibility, when you talk about genetic evaluation, of it having to do with the alteration of genes or cross-breeding? It won't lead to it in any form at all?
Dr. Morrissey: My understanding, Mr. Chairman, of that document is that it refers to the privatization of the record of performance, which is just the collection of data.
The use made of that data afterward by agencies for such things as AI or embryo transfer is for their breeding programs and the genetic evaluation of the animals they have previously bred.
The Chairman: Thank you.
Two more questions: Madame Guay and Madam Kraft Sloan.
[Translation]
Ms. Guay: Mr. Chairman, I look at how we pass legislation on pesticides. We have a problem right now and we are very aware of it in Quebec. We keep passing legislation and allowing the use of new pesticides, but we are cutting back in the research that we do on products that are organic, normal and friendly to the environment.
You have told me that your definition of biotechnology is the same as ours. A hormone called bovine somatotropin is now being prepared. It's going to be launched on the market. We're told that there are no obligations to indicate on a label the presence of this hormone in milk. When it comes to cigarette packages, very visible warnings stating that smoking is dangerous to your health are put on the packages, but we don't have the right to know what we're going to consume.
CEPA is going to have to contain a very specific definition of biotechnology and we're going to have to enforce it. All departments should conform to such a code of ethics. The current situation is most disappointing and worrisome. This is simply a comment which I wish to make.
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The Chairman: Ms Kraft Sloan.
[English]
Mrs. Kraft Sloan: Thank you, Mr. Chair.
Michael Porter said that consistency and strength of regulation is what industry is looking for. He said it's looking for some predictability. I was just wondering how the witnesses feel about the fact that the government response in CEPA allows for differing minimum standards. If there is a possibility of regulation by industry associations, we're going to have some very inconsistent baselines and increased unpredictability. That kind of defeats what Michael Porter is suggesting industry really wants.
The Chairman: Mr. Buccini, please.
Mr. Buccini: I'll attempt to reply to that. I can only speak from my experience, and, like others, I'm not going to be able to predict future events or behaviour of humans very well.
In working with the industry in consultations and in other matters, it has been my experience that the predictability of a first-class regulatory regime is viewed as an asset in terms of business planning. From my point of view, it also will help us implement the precautionary principle, the pollution prevention principles and a variety of other elements favourable to protecting health and the environment.
With regard to the possibility of agreements with industry, which you mentioned, the CEPA regulations, in fact, if I can speak to that one specifically, really don't allow for that. It is an across-the-board safety net approach.
Mrs. Kraft Sloan: I'm not referring to CEPA; I'm referring to other departments.
Mr. Buccini: The other point I'd make is that, as Dr. Morrissey has indicated, the possibility of having the suite of agriculture biotechnology products regulations in the public domain at the same time as the CEPA ones will provide a very good opportunity for the whole regime to be examined.
If your concern is the possibility that there may be exemptions or relaxation from some of those regulations, that's just something we'll have to think about and deal with in the consultation phase. Reacting to your question directly, if they were exempted from other federal statutes I think they would default back to the CEPA regs. That's how we see the safety net operating.
You may wish to have a look at the set of regulations when they are in part I of the Canada Gazette for public comment, to see whether your concerns are still substantiated or not.
The Chairman: Thank you.
Mr. Knutson, would you like to make a final comment?
Mr. Knutson: No, thank you.
The Chairman: In that case, I thank you very much.
I also thank the members of the natural resources committee for their patience.
I thank each one of you in particular for appearing here this morning. You can see there is quite a gap to be bridged between the respective departmental thinking and the political thinking. We will endeavour to explore further and bridge this gap in the weeks ahead. We may have to come back to you in June.
This meeting is now adjourned.