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• A.What is Biotechnology?
• B. Innovative Applications and Future Marketing Possibilities
• C. Biotechnology and the Primary Producer
• A. The Investment Climate
• B. Intellectual Property
• C. Basic and Directed Research
• D. The Regulatory Framework

INTRODUCTION

The subject of biotechnology seems to attract equal amounts of fascination and apprehension from the general public. The reason is not only the nature of the innovative applications that are taking place in this field but also the pace at which they are proceeding. Managing these changes presents a challenge. It is within this context that the Government of Canada decided in February 1998 to renew its 1983 biotechnology strategy to reflect the implications of Canada's exploding biotechnology industry.

Many of these new technological advances are taking place in the agricultural sector. In view of the long-standing interest in the subject of biotechnology of the House of Commons Standing Committee on Agriculture and Agri-Food, Committee members considered it important that they have input into the renewed biotechnology strategy.

Feeling that they should educate themselves about the emerging new technologies, members of the Committee travelled to Saskatoon, North America's prime agricultural biotechnology centre, in early April 1998. After being informed about the new crops, vaccines and specialty products that are being developed there, the Committee held a series of hearings in early May to canvas the views of the innovators, the users, the regulators as well as those of the public. This report is the result of those findings.

PACE-SETTERS IN THE AGRICULTURAL BIOTECHNOLOGY COMMUNITY

A. What is Biotechnology?

The Canadian legislation for agricultural products and the Canadian Environmental Protection Act define biotechnology as follows:

Biotechnology means the application of science and engineering in the direct use of living organisms or parts or products of living organisms in their natural or modified forms.

This covers a wide range of processes, from fermentation (the use of yeast to make bread rise for instance) to latest reproduction methods such as cloning, and to recombinant DNA technology (also called genetic engineering). ¹

Biotechnology is considered by some as a tool. It is, in principle, something that nature already does, and that human beings have used for thousands of years. As Dr. Kelvin Ogilvie, President of Acadia University put it,

Living organisms have been used to produce goods and services for thousands of years. So if that's the case then...why the excitement or sudden interest in biotechnology today? That is because of our ability to make relatively rapid changes in living organisms... nature has been transferring genes from one organism to another probably since time began...scientists learned how nature was doing that and it learned the techniques of doing it in the laboratory.

Genetic engineering is more controversial for some people, such as Mr. Burkhard Mausberg, Executive Director, Canadian Environmental Defence Fund, who thinks it may be ethically unacceptable:

...for the last 25 or 26 years we've been able to do something that evolution previously was not able to do and that is to mix totally unrelated species of genetic material and make something new...We're doing something that is fundamentally unnatural...you find things like people thinking we are playing God, or that in using genetic engineering technologies we are playing God.

These diverse viewpoints typify the range of opinions circulating about the subject of biotechnology.

B. Innovative Applications and Future Marketing Possibilities

The application to agriculture of cell and tissue culture techniques, molecular genetics, cloning, and recombinant DNA methods has led to considerable progress in production, quality and productivity. Many biotechnology products are already used in agriculture: plants with novel traits (herbicide or insect resistance, and delayed ripening for example), microbial products used in feeds (forage additives), microbial fertilizers, and vaccines and diagnostic kits in animal health or care.

The widespread use of biotechnology techniques is leading to the development of many other products. In crop production, for instance, we are seeing a progression from products with a single genetic change (mainly agronomic traits), to value-added products creating future marketing opportunities. Examples are:

• nutritionally modified foods;
• nutriceuticals and functional foods that could reduce the risk of chronic disease;
• plants used as vectors to produce vaccines or pharmaceuticals, feed additives, industrial agents such as detergents or plastics; and
• production of paper or fuel from straw or cornstalks.

In animal husbandry, biotechnology products range from vaccines to transgenic animals with traits desirable for marketing (leaner meat, for instance), or from whose milk pharmaceuticals are extracted.

Biotechnology is seen as the "third wave" of technology, after mechanization and agri-chemicals, that will help to improve agricultural production. It will have a role to play in:

• increasing yields needed to compensate for the increase of world population;
• developing more sustainable agricultural practices, by reducing the use of pesticides; and
• creating new markets by introducing value-added products.

Biotechnology is also seen as a means of helping Canadian farmers remain competitive in the global market, and meeting the export target of $40 billion by the year 2005.

C. Biotechnology and the Primary Producer

The current trend of agricultural biotechnology products continues the evolution from producer-to consumer-oriented products. The first products to be developed were transgenic seeds with agronomic traits such as herbicide resistance, their economic benefits for producers were obvious. Research is now focusing on value-added products such as nutraceuticals, and pharmaceuticals grown in plants or extracted from the milk of transgenic animals, whose impact on the producer are not clear.

According to Dr. Murray McLaughlin, President, Ontario Agri-Food Technologies, the new developments will help some farmers move away from growing traditional crops (wheat for instance) and turn to production of more diversified crops. It is suggested that biotechnology will help farmers to diversify, for instance, by growing more specialty crops for specific niche markets. Members asked questions about the impact on farming of diversifying into value-added products. For example, according to Mr. Jeffrey Turner of NEXIA Biotechnologies Inc., 10 or 20 goats could produce the world's supply of a therapeutic material. While society at large will certainly benefit, the question is, are the markets of these value-added products important enough to involve a majority of primary producers? Mr. Turner sees biotechnology as benefiting Canadian agriculture more through the ability to add features that improve production, such as agronomic traits.

During the hearings, examples of producer benefits always came from first-generation changes to agronomic traits; this seemed to suggest that primary producers would not necessarily go on to capture the benefits of moving to second-generation consumer-oriented, value-added products such as nutriceuticals and functional foods. Increasingly it appears that producers will provide inputs for the manufacturers of value-added products. Dr. Bernard Laarveld, of the Department of Animal and Poultry Science, University of Saskatchewan calls this process - whereby commodities become inputs for value-added products - "de-commoditizing." During their visit to Saskatoon, Dr. Laarveld told members that without significant restructuring, this process has the potential to marginalize small farms. The Committee has some concerns in this regard. In order to keep viable, farmers will have to choose from a wide variety of traditional and other crops.

Recommendation 1

The Committee recommends that the Government of Canada, including line departments such as Agriculture and Agri-Food Canada, assist primary producers in finding new markets and ensure that they are kept informed of all marketing opportunities for products of biotechnology.

Another issue facing primary producers is access to and cost of the new products. There is a general thought that, in the future, small ag-biotechnology firms could be taken over by larger global businesses. Mergers are already occurring in the seed sector and if a small number of companies control production, the cost of this particular input could be higher.

Dr. McLaughlin, and Mr. Tom Lasseline of the Soybean Growers Marketing Board, think the producer would not buy the biotech product unless it increased profits, regardless of who was controlling the seed source. According to the Fédération nationale des associations de consommateurs du Québec, farmers are becoming more and more dependent on these technologies; with fewer manufacturers to supply them, there would be less choice available to them. It is important for farmers to have access to many different options. It is thought that not all seeds will be genetically modified.² In that case, farmers would be able to weigh the input costs versus the benefits and decide what kind of crop they want to use.

According to Ms. Margaret Gadsby, Director, Regulatory Affairs, AgrEvo Canada Inc., the ongoing reorganization in the food production chain is inevitable; where margins are slim, small companies have to be integrated if they want to survive. Furthermore, Ms. Gadsby commented that if we insist on cheap food, inputs have to be highly controlled to ensure some profit for each link in the food production chain. She insisted that industry in Canada is aware of the fact that it must leave money in the farmers' pockets.

MAINTAINING A LEADING EDGE IN TECHNOLOGY TRANSFER

A. The Investment Climate

The main agricultural products marketed in Canada are transgenic crops (canola, corn and potatoes). To produce this first generation of crops, large multinational companies, with the resources to take new products through long development phases into commercialization, took over small companies that had proprietary technology in transgenic crop breeding. In just two years, the acreage sown to transgenic canola went from 0 to 1.6 million hectares (30% of total sown area). The trend is the same for corn and potatoes.

Encouraged by the success of transgenic modification of conventional crops, research has continued and has already demonstrated many other applications. Universities, government scientists and the more than 70 Canadian-owned smaller firms developing agricultural applications of biotechnology are carrying out much of the development work for the second- generation products. These companies encounter the normal problems faced by small, high technology start-up and developing companies.

It takes very large amounts of capital to develop and market products and a relatively long time to achieve an acceptable return on the capital invested. Finding the necessary money is made more difficult because the agricultural sector is relatively invisible to venture capital partnerships. If there is not enough funding, small biotechnology companies could be taken over by larger global businesses as happened in the case of seeds. Now, however, government programs and initiatives, such as the federal government's new Technology Partnerships Canada program, and the Matching Investment Initiative, are offering funding. Innovation Place, a cluster of 100 biotech companies based in Saskatoon, is another example of how government-industry cooperation can foster the development of small, ground-breaking companies.

Despite the fact that agriculture is one of the top five industries in Canada, capital investment in health-care-related biotechnology exceeded that in food and agriculture in the ratio of 10:1 in 1991-1995. The ratio worsened significantly in 1996 to almost 1 in 70, possibly somewhat related to the fact that health products yield a higher rate of return on investment. Mr. Roy Atkinson, the Executive Director of the Canadian Biotechnology Strategy Task Force, recognizes that there are significant differences in the challenges and opportunities arising from the agriculture and health sectors. Ms. Gadsby believes those differences somehow have to be incorporated into the Canadian Biotechnology Strategy. Agriculture has special needs, especially given the current international environment. The agri-food sector has to be able to market biotechnology products without experiencing financial disadvantage or losing market share.

According to Ms. Joyce Groote, President, BIOTECanada, Canada is recognized as a leader in terms of advancing agricultural biotechnology and exploiting it to keep the economic benefits at home. However, Canada is still facing some challenges; Germany, Australia, and other countries are spending billions of dollars to become more competitive. Ms. Groote stressed how important it was for Canada to maintain its competitive edge in the field of biotechnology.

With vibrant cluster developments such as Ontario Agri-Food Technologies and Saskatoon's Innovation Place, the Committee is optimistic that the agri-food industry has the tools to keep a competitive edge. As the new products move more and more into the nutriceutical and therapeutic fields, agricultural biotechnology is likely to attract the needed investors.

B. Intellectual Property

A country's regulatory framework for intellectual property influences where businesses choose to develop and market their products. Industries investing significant amounts of capital to develop their products want the results of their research to be protected. Currently, the Canadian Intellectual Property Office gives patents for unicellular microorganisms (bacteria, fungi, etc.); however, there are no patents for multicellular life forms. According to Agriculture and Agri-Food Canada's Consultation Document for the Renewal of the Canadian Biotechnology Strategy, the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) and the North American Free Trade Agreement (NAFTA) do not require Canada to patent higher life forms if protection is provided by an effective, alternative system. In Canada, the Plant Breeders' Rights Act provides protection for new plant varieties, but there is still no protection for animal life forms.

A patent can provide very strong protection since it prohibits: (i) the creation of new varieties from the patented genetic resource; (ii) keeping a part of the harvest; and (iii) commercializing the next generation as seeds. Created in 1961, and defined in the 1978 Convention of the International Union for the Protection of New Varieties of Plants (UPOV), plant breeders' rights differ from patents in certain ways. This type of intellectual property right (IPR) protects the plant breeder by being able to charge a royalty to users and to control the sale of propagating material; however, unlike a patent, the plant breeders' rights allow anybody to use any seeds in order to create a new variety without paying any royalty, and also recognize the "farmer's privilege" to use a part of the harvest to sow fields. The 1978 Convention prohibits a double protection via both patent and plant breeders' rights.

While Canada has ratified the 1978 Convention, it has not yet ratified the revised UPOV Convention of 1991, which would extend coverage to "essentially derived varieties and to harvested materials." This 1991 Convention would allow double protection through patent/plant breeders' rights, would give up the "farmer's privilege," and create dependence for varieties created from other varieties.

Currently, there is free access to genetic resources. Free access, plus the strong protection of research results - to be addressed in 1999 when the provisions of the WTO Agreement on TRIPs respecting the patentability of superior life forms is reviewed - will give biotechnology industries important tools for developing new products. Companies are already concerned about the use of their genetically engineered seeds and require some farmers to sign contracts that forbid seed saving.

Recommendation 2

The Committee recommends that the Government of Canada continue its implementation of an intellectual property framework that, without giving up the farmer's privilege, will foster the development of new biotechnology products.

C. Basic and Directed Research

The successes of biotechnology have been due largely to the strength of long-term research activities at public institutions. Numerous methods developed by scientists at Canadian government and university laboratories are now fundamental tools used by plant breeders throughout the world. Basic research on the application of cell and tissue culture techniques, molecular genetics and recombinant DNA methods has opened the door to a new kind of agriculture.

More recently, the emphasis has been on partnerships between government, academia and industry organizations, that allow the transfer of research discoveries to potential industrial users. Many of the new plant discoveries cited in this report were introduced into the marketplace as a result of these joint ventures.

Nevertheless, according to Ms. Gadsby, some agricultural production systems in Canada are too small to attract commercial interest. She called on government to decide whether such research warranted the spending of public funds to support the existing research network to allow it to continue such basic research. The Committee supports such a concern, both for projects of major international potential and where the research builds on Canadian strengths and commercial possibilities.

Recommendation 3

The Committee recommends that funding for Agriculture and Agri-Food Canada R and D programs in long-term basic research be increased to keep Canada at the forefront of biotechnology developments.

Also raised was the related issue of the availability of world-class researchers, as discussed in the Sixth Report³of the National Biotechnology Advisory Committee (NBAC), released earlier this year. The report recognized the need for Canadian biotechnology companies to attract highly qualified manpower and internationally experienced biotechnology managers. It also recognized that government must have access to the best scientific expertise if it is to make the best regulatory decisions. Evidence before the Committee endorsed the urgency of the NBAC finding that there is a clear need for training and education to increase and foster the available human resources. The Committee believes this is particularly important for the agri-food sector in light of the ability of the health sector to compete for highly qualified individuals.

Recommendation 4

The Committee recommends that the government work with all relevant parties to develop strategies, such as cooperative internship programs, to attract students to the field of agricultural biotechnology.

D. The Regulatory Framework

The pace of development of biotechnology necessitated a response from regulators to ensure that developments would proceed in a way that protected health, safety and the environment. Ms. Margaret Kenny, Acting Director, Office of Biotechnology, Canadian Food Inspection Agency (CIFA), outlined for the Committee the principles behind the federal government 1993 regulatory framework. It aimed to:

• maintain Canada's high standards for protecting the health of Canadians and the environment;
• use existing laws and regulatory departments to avoid duplication;
• develop clear guidelines for evaluating biotechnology products that are in harmony with national priorities and international standards;
• provide a sound, scientific knowledge base on which to assess risk and evaluate products;
• ensure that the development and enforcement of Canadian biotechnology regulations are open and include consultation; and
• foster a favourable climate for investment, development, innovation and the adoption of sustainable Canadian biotechnology products and processes.

In terms of regulation, the new products of biotechnology, including Genetically Modified Organisms (GMOs), are not considered fundamentally different from traditionally bred organisms in terms of risk assessment. A product-based, rather than a process-based, approach is used; each new product is evaluated in accordance with current scientific knowledge on its own merits and characteristics. Interactions with the environment or impacts on health are determined by these characteristics, and not by how the product has been developed.

Under this regulatory framework, the regulatory authority for biotechnology is shared by a number of federal departments and agencies as seen in the following chart.

Products regulated	Federal department(s)	Act	Regulations
Products for uses not covered under otherfederal legislation	Environment Canada Health Canada	Canadian Environmental Protection Act	New substances Notification Regulations
Drugs, cosmetics, medi cal devices, and foods	Health Canada	Food and Drugs Act	Food and Drugs Regulations, Medical Devices Regulations, Cosmetics Regulations
Fertilizer supplements, including novel micro bial supplements	Canadian Food Inspection Agency	Fertilizers Act	Fertilizers Regulations
Feeds, including novel feeds	Canadian Food Inspection Agency	Feeds Act	Feeds Regulations
Plants, including plants with novel traits, includ ing forest trees	Canadian Food Inspection Agency	Seeds Act	Seeds Regulations
Veterinary biologics	Canadian Food Inspection Agency	Health of Animals Act	Health of Animals Reg ulations
Pest control products	Health Canada Pest Management Regulatory Agency	Pest Control Products Act	Pest Control Products Regulations
Aquatic organisms	Fisheries and Oceans	Fisheries Act	Fisheries Regulations
Source: Adapted from Government of Canada, Renewal of the Canadian BiotechnologyStrategy, Resource Document, Ottawa, Industry Canada, 1998, p. 13.

As far as agriculture and agri-food are concerned, the Canadian Food Inspection Agency conducts safety and environmental assessments of fertilizers, seeds, plants, plant products, animals, vaccines, animal disease diagnostic kits and feeds. It also enforces portions of the Food and Drugs Act. Health Canada is responsible for assessing the safety of novel foods that include biotechnology products. According to Mr. Paul Mayers, Head, Office of Food Biotechnology, Health Canada, that department has proposed a new division to the food and drug regulations which would define the concept of a novel food; the division would require notification for such a food prior to its sale or advertising for sale in Canada. This would permit the department to conduct a thorough safety assessment for each such product over a 90-day period. Novel foods would include, but not be limited to, foods derived from genetically modified organisms. Health Canada is at present revising its notification proposal to reflect comments from interested parties and will then published it in the Canada Gazette, Part I, for further comment.

For a risk assessment, Canada uses the international standard of "substantial equivalence," which is based on a comparison of the novel product to traditional products, with an acceptable level of safety. Mr. Mayers conceded that, while there was no such thing as "zero risk" or "absolute safety," comparing the new product with familiar "safe" products enables Health Canada to assess not only the potential acute effect of a particular food but also its long-term effect, based on knowledge of the long-term effects of its traditional counterpart. The safety assessment compares the composition and nutritional quality of the novel product with those of its traditional counterpart and any potential toxic or allergenic effect. If there is no traditional counterpart, the new food must be evaluated in a more detailed way on the basis of its own composition and properties. The emphasis is on the novelty of the product, not its biotech components, since other foods that are new to the Canadian marketplace may also pose a potential risk.

According to many witnesses, the regulatory system in Canada has served as a model for several other countries and is well respected for providing a safe food system in this country. To date, 30 plants with novel traits have been reviewed and accepted for use in the Canadian marketplace. According to Health Canada, many of today's novel foods are traditional products modified for agronomic improvements in terms of quality.

Canada requires food offered for sale to the Canadian public to be safe for consumption. Labels of novel foods must identify the presence of any potential health or safety risks for certain individuals or population segments. Labels also have to identify any significant compositional or nutritional changes from the traditional food source. It is left to the product developer to choose whether to declare that a food has, or has not, been developed through biotechnology. Thus, unless there has been a nutritional or compositional change to the novel food, the labelling of genetically modified foods is strictly voluntary.

The responsibility for the labelling of products is shared between the CFIA and Health Canada. The CFIA is responsible for non-safety-related labelling, that is, voluntary labelling and labelling for protection against consumer fraud; Health Canada is responsible for obligatory labelling related to health and safety issues, that is, allergenicity, changes in nutritional composition and so on. The Committee heard that there is considerable debate in Europe over the subject of labelling. Current discussions would suggest support for three types of labelling: "this food comes from genetic engineering"; "this food does not come from genetic engineering"; and "this food may come from genetic engineering." Switzerland already has legislation dealing with the labelling of genetically modified food. A Swiss manufacturer has to prove its product is GMO-free or it is labelled produit OGM (for a genetically modified organism product).

One problem brought out in the hearings was the difficulty of substantiating a label's claim that a product is free of genetically modified ingredients. According to the Consumers' Association of Canada (CAC) representative Ms. Christine Mitchler, "there is no cost-effective, scientific or evidence-based way…to support or substantiate the accuracy of such a claim." CAC is concerned that mandatory labelling (such as "may contain genetically modified ingredients") may become meaningless in a few years if it could apply to virtually every food product.

Evidence at the hearings demonstrated that there are almost as many views on the subject of labelling as there are new products. This situation is likely to increase as these products evolve from being an invisible farm product to being a visible food on the grocery store shelf. While Health Canada and AAFC obviously consider that the labelling issue with respect to health and safety has been resolved, not everyone seems to agree. A clearer understanding of the reasons behind Canada's labelling policy is needed. More and more responsibility for filling information gaps is falling on the entire food chain, and is likely to present a growing challenge as new products enter the marketplace.

Recommendation 5

In light of the rapid development of food production technologies, which has led to unresolved issues surrounding labelling, the Committee recommends that Parliament, in consultation with all stakeholders, undertake a review of Canadian policy on labelling.

While both CFIA and Health Canada have websites to inform the public about product decisions and regulatory approaches, there is still some doubt as to the level of public awareness of the regulatory system. The importance of having a system that is understood and trusted was mentioned several times during the hearings. Trust in the health and environmental protection afforded by the regulatory system is seen as fundamental to building public confidence. Only if departments are able to separate their regulatory from their promotional role, will they be able to be useful and informative about regulatory safeguards.

It is clear that trust is a key feature in the public's acceptance of novel products. According to Ms. Laurie Curry, of the Food & Consumer Products Manufacturers of Canada, "Ultimately, biotechnology will be judged not on the data but on who is speaking for it." Consumers can accept that some events may be unforeseen, but they need to know that such risk is minimized by a good regulatory system. They also need to be sure that persons explaining biotechnology are doing it in a balanced way and are providing trustworthy information.

Also important to public acceptance of the regulatory system is public involvement in regulatory decisions about agricultural biotechnology. Since 1988, there have been many consultations on development of the regulatory framework for agricultural biotechnology. The AAFC on its website states, "It has been important to involve and obtain the input of members of the public during the development of the regulatory framework, since it would be impractical to accommodate public input into regulatory decisions on a product- by-product basis." In addition, "decision documents" are issued that explain in detail what the regulators reviewed and the scientific basis for their conclusions.

THE PUBLIC DIALOGUE ON BIOTECHNOLOGY

The role of the public has been a prime focus in the Canadian Biotechnology Strategy renewal. Through cross-Canada consultations, Industry Canada, AAFC, and other line departments, are attempting to discover what information the public needs about biotechnology products and how the public can participate in discussions on biotechnology, including its social and ethical implications. Discussions on renewal of the government strategy recognize that there is still considerable work to be done to raise public awareness of biotechnology and its opportunities and challenges. One witness urged that the strategy become a communications strategy.

According to the Consumers' Association of Canada, consumer acceptance of any new food product depends on the provision of accessible and accurate information that will enable consumers to make informed choices where the perceived benefits exceed perceived risks. According to Ms. Mitchler, the perception of some consumers that genetically altered foods are different from conventional foods has been fuelled by misinformation. If, as another witness pointed out, the issue is not access to information but rather ability to evaluate information, teaching the public to evaluate information must be an important part of the educating process. Only then will issues surrounding misinformation subside. The neutrality and balance of such an educational process was stressed. While companies can do their part in providing information, the public needs other help to make informed choices. Consumers need to be in a position to evaluate the risks and benefits of food biotechnology. They are more likely to choose products where they perceive the benefits to be obvious.

Consequently, products that offer value to the customer will be more readily accepted, the Committee heard, as long as information is available to help the consumer make an informed decision. Canadians tend to be more supportive of medical applications of biotechnology than food applications, since the utility of life-saving applications (eg. insulin) is more readily apparent. In a country where food has always been safe and abundant, however, the need for technological change is less obvious. Dr. Ogilvie said that it might be an extreme example but the introduction of the milk hormone rbST(recombinant bovine somatotropin) as the first visible food product of biotechnology could be compared to using the electric chair to demonstrate the utility of electricity. The objective of rbST was to boost milk production here in Canada, a country with a plentiful milk supply. The milk hormone is still awaiting approval by Health Canada; it was approved for use in the U.S. in November 1993.

A Committee member reiterated that the public needed to see the usefulness of a new biotech product, for instance developing a lush, low-growing grass for lawns that rarely needed cutting - already a possibility down the road - would obviously be quite popular. The Committee was told that a willingness to accept new products has been demonstrated where their benefits in solving a problem are well understood. This was the case with the NatureMark potato. It was offered as a product that could be grown a better way, with a reduced amount of pesticide, to Atlantic consumers who were familiar with the pest the NatureMark potato was combating. Thus providing information geared to the consumer's level of understanding appears to be the most useful approach. Communicators need to know what information is appropriate for specific segments of the public and respond appropriately. The Saskatchewan AgBiotech Information Centre is used as a successful example of providing an appropriate level of information to the public.

With the explosion of agricultural products that is occurring, educating the public is going to become an increasing challenge. In addition to individual measures to inform the public about the benefits and risks of biotechnology, the Committee believes there is a role for a mechanism that would monitor biotechnology developments in agriculture and act as an independent clearing house for information on the latest products of biotechnology. The Committee believes it is important that the new mechanism concentrate on products emerging in the agri-food sector.

Recommendation 6

The Committee recommends that there be an independent clearing house for information about new products of agricultural biotechnology.

To assist the communication process, the Government of Canada is also considering establishing a body that might facilitate the public dialogue, especially with respect to social, economic and ethical issues. Recommendations for such a body will form a major part of the renewed Canadian Biotechnology Strategy. Mr. Atkinson reported that the round tables that took place during the renewal consultation process had reached consensus that the advisory body should:

• report to the Ministers, because biotechnology crosses many different sectors;
• be expert-based and not advocate for stakeholders. Discussions took place on whether the advisory body should be stakeholder-based or general public or expert-based. It was agreed that a stakeholder-based body makes it difficult to reach a consensus and that experts are probably the best choice, although polling results showed half of the population trust them and the other half do not;
• be open and transparent. Thus both those who trust experts and those who do not trust experts can make sure they have input into the process;
• deal with emerging issues that are important to the public at large; and
• consult and engage all the stakeholders.

The National Biotechnology Advisory Committee has been advising the Minister since the National Biotechnology Strategy was established in 1983. In its aforementioned Sixth Report, the NBAC recommends that its mandate be expanded to include a socio-ethical dimension and a public role of fostering awareness and input. The goal is to generate broad public support. According to the NBAC, such a dialogue is already underway by many of Canada's major trading partners. The role of NBAC members would be to stimulate the dialogue and supply relevant scientific information. The Committee did not hear much opinion about the possible makeup of such an advisory body.

The NBAC would continue to advise Ministers on the direction and pace of biotechnology and its commercial applications. The Committee has some reservations about whether the body promoting biotechnology should at the same time be central to public debate on the subject; it would rather see some distance between the two functions.

Separating the business and the public dialogue function is an approach evidently supported by BIOTECanada. In this way, the two functions could be kept separate.

CONCLUSIONS

Agricultural biotechnology is set to offer an amazing array of new products to promote plant, animal and human health. Agricultural biotechnology is competing with the health sector for investment dollars but the sector has taken a number of initiatives that should help keep it on the competitive edge. More threatening is competition coming from Canada's major trading partners.

As the agricultural biotechnology industry moves increasingly into value-added products, primary producers have to be partners in all the strategies, including those pertaining to intellectual property.

Canada has put in place a regulatory system that is internationally accepted and with which it feels comfortable. Key to acceptance of new products of biotechnology will be public confidence in the regulatory system.

The Government of Canada is wrestling with the issue of public involvement in the issues surrounding biotechnology. It is important that any public consultation means or mechanisms be objective about the benefits and risks of biotechnology. Government decision makers must understand the basis of public controversies about biotechnology and its applications if they are to pursue effective and acceptable policies.

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