FINDINGS, ISSUES AND RECOMMENDATION. Introduction

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1 FINDINGS, ISSUES AND RECOMMENDATION Introduction The goals of this advisory notice were to take stock of current scientific knowledge about the health and environmental impacts of genetically modified organisms used in the agri-food industry, and to identify what issues specific to Québec are raised by these types of GMOs. The Conseil de la science et de la technologie du Québec sought to discharge its duties by presenting, as thoroughly and factually as possible, an overview of the information available on the question, in its scientific (chapters 1 and 2), economic (Ch. 3), regulatory (Ch. 4) and social/ethical (Ch. 5) dimensions. This summary of the original advisory notice aims to paint a succinct portrait of the main findings that the Conseil reported on in those chapters, with a view to highlighting the most significant issues for Québec and making a number of recommendations. The Conseil s opinion essentially covers those genetically modified plants that are part of the food industry. It does not extend to the case of GM plants produced for medicinal or industrial purposes, nor does it deal with animal transgenesis and its many possible applications (including those in the food industry). The Conseil does, however, wish to underscore the fact that many of the environmental issues raised in connection with plants destined for human consumption also apply to other genetically modified plants, as well as to transgenic livestock (notably fish). Moreover, the potential introduction into the human food chain of transgenic animals or products derived therefrom should naturally give rise to questions regarding their safety as far as the health of humans is concerned. The GMO situation is a rapidly evolving one. Transgenically sourced foods pose challenges on an international scale, in a context marked by much controversy. This makes the future of GMOs difficult to predict and, indeed, it is even difficult to state categorically that GMOs are here to stay, whether in Québec or elsewhere. Note that the Conseil s findings, issues and recommendation are transitory and valid only over the short term. The situation will have to be periodically reassessed in Québec and in the rest of Canada, as well as around the world. Québec must closely monitor the issue as it

2 evolves. Findings and observations This subsection presents the most significant overall findings that emerge from the report chapters, in the same order as that in which the topics were originally presented in those chapters. Virtually all (99%) genetically modified plants cultivated worldwide belong to four species: maize, soybean, rapeseed and cotton. These so-called first-generation transgenic plants were originally modified for agronomic purposes essentially, to make them resistant to destructive insects and more tolerant of herbicides. These four species began to be cultivated intensively in the mid-1990s in a few countries, including Canada. The characteristics of the first-generation GMOs did not directly concern consumers because the latter derived no particular benefit from these foods. On the other hand, several of the genetic modifications involved in GMOs currently being produced experimentally around the world do aim at the development of characteristics that could prove beneficial to consumers: enhanced nutritive value, neutralization of allergenicity in certain plants, medicalized foods, and so on. Other products could have beneficial effects on the environment. These GMOs of the future are still in the planning stages, and their benefits to society remain hypothetical. Commercial production of transgenic crops for human food purposes is still a relatively recent phenomenon, but one that has undergone significant expansion over the past few years. Both the land areas devoted to these crops and the number of countries producing them are constantly on the rise. At the same time, there is also strong resistance to GMOs worldwide. Groups opposed to this technology and its products are leveraging public opinion and lobbying governments, pointing to a variety of potential health and environmental risks. Some countries in Europe and Asia have declared moratoriums or placed severe restrictions on the production and importing of genetically engineered products. No food-related or environmental catastrophe linked to GMOs has yet been reported since

3 transgenic crops went into intensive production. This experience (only a few years) is too recent and too limited, however, to enable any conclusions to be drawn regarding the safety of GMOs in general. More specifically: 1. These experimental results involving four plant species cannot be generalized to encompass other plants or other types of genetic modifications. 2. It has not been possible, as of yet, to assess the potential health and environmental impacts of first-generation GMOs over the long term. 3. The true degree of consumer exposure to GMOs remains uncertain. There is no information that can serve to state in what proportion and under what form genetically modified products may be present in the foods currently available on the market. The key potential risks to human health posed by GMOs are toxicity, over both the short and long terms, and allergenicity. These risks are linked either to the direct effects of the gene in question, or to so-called pleiotropic (i.e. secondary) effects. Another potential risk is linked to the use of a type of marker gene that codes for resistance to certain antibiotics. The key potential environmental risks of GMOs are as follows: modification of root zones, including horizontal transfer of genes to soil bacteria; unwanted propagation of transgenic plants themselves; the transfer of genes from transgenic plants to noxious or wild plants that are similar to them; the emergence of insecticide-resistant insects; and adverse effects on biodiversity, especially among non-targeted species. Scientific knowledge of the health and environmental impacts of GMOs is currently insufficient and inconclusive. Although work has been done on the subject since the 1980s, there is a general paucity of recent studies dealing specifically with the assessment of potential risks as well as benefits. Consequently, scientifically valid knowledge of the effects of GMOs is still very limited, for example, regarding the risks related to gene flow from transgenic crops, or the potential long-term toxic effects of certain transgenic proteins (chronic toxicity). While many of the fears about the impacts of GMOs are theoretically plausible, the probabilities associated with each of the identified risks remain difficult to assess. For

4 example, the concern that a super weed could develop via the integration of a powerful adaptive transgene is theoretical, but should not be discounted. With respect to health risks, existing testing procedures are adequate for assessing the acute or immediate toxicity risks of pure proteins, but remain inadequate for determining the potential allergenicity of novel proteins (whether genetically modified or not), which up to now have not been part of the human food chain. Nor are there reliable methods of measuring the probability that toxic effects might manifest themselves over the long term (this is also the case for many of the chemical substances present in food). Observation: Scientific experimentation allows us to quantify the frequency and severity of risks posed by novel foods. Research results enable us to assert, for example, that given the current state of knowledge, no toxic effects have been found under conditions a, b and c and after tests x, y and z. The development of new, more accurate measurement techniques may alter these results, however. From this perspective, zero risk is not scientific. Scientific knowledge is in constant progression; what is taken for granted now can always be questioned later, as new, scientifically valid data become available. Current knowledge does not allow us to validate the hoped-for benefits of GMOs either. Up to now, the two major types of genetic crop modification have mainly served to meet classic farming needs. Combatting noxious agents is one of the major challenges of agricultural production on any scale. Introducing the right pesticide into a plant s gene pool and rendering that same plant resistant to a particular herbicide basically serve the same purposes as other techniques employed to protect crops from invasive insects and weeds. Ideally, it should be possible to compare the benefits of transgenesis as well as its potential risks to the advantages and risks involved in the use of other production methods. At the moment, there are very few comparative data of this kind. What results are available are more often than not partial: observed productivity gains vary from one species to another, from one season to the next, and from one region to another. The same goes for the environmental benefits (e.g. curtailment of the use of pesticides and herbicides, reduction of soil erosion). In this area, more systematic assessment would appear necessary. With some three million hectares of transgenic crops, Canada is the third-largest producer of

5 GMOs in the world, behind the United States and Argentina. In Québec, farm production of GMOs is not a marginal enterprise: approximately 25% of land where the species in question are grown is devoted to GMOs. In 2001, 27% of the corn and 16% of the soybeans cultivated here were genetically modified varieties. In the case of rapeseed, which is still a marginal crop in Québec, 75% of land where it is grown is devoted to transgenic varieties. Almost all of the GM corn produced is destined for animal feed. About 70% of the GM soybean crop is destined for overseas export markets. The value of transgenic crops grown in Québec in 2000 is estimated at $84 million. World seed and GMO production is the purview of a small number of major biotechnology companies. In Québec, 15% of biotech firms are involved in farming applications, and only a few of these are developing GM products for farming or food industry purposes. In Canada, federally funded research centres and the universities are major players in agri-food research. The number of university researchers active in the field of plant transgenesis in Québec is limited: there are about fifteen. Several ongoing projects in plant and animal transgenesis are related to the health field. Very few involve the development of GM foods. According to statistics supplied by the Canadian Food Inspection Agency (CFIA), ten confined field trials were authorized in Québec during 2000; this amounts to 1% of the Canadian total. The health and environmental impacts of GMOs are of interest to all of the industrialized nations as well as to more and more developing countries. Research in the field has given rise to an international scientific effort. In addition, international organizations such as the Codex Alimentarius Commission are being called upon to play a major role in developing, to a certain degree, standards and principles for control of GMOs. Currently there is no homogenous international regulatory framework surrounding GMOs. Countries such as the United States and Canada classify GM foods as novel foods, and do not require any particular labeling of GMOs. In other countries, including some European states, GMOs are subject to specific regulations and labelling rules. This disparity in international

6 regulatory standards can be linked to problems of circulation and marketing of certain types of food among certain countries. In Canada, the bodies charged with assessment and certification of transgenic crops and novel foods are under federal government jurisdiction: they are the CFIA and Health Canada. The provincial governments are not involved in the process. Québec is kept informed of the field trials taking place within its territory, but has no decision-making input. The GMO assessment and certification process in Canada has come under severe criticism for a perceived lack of transparency and accountability, inaccessibility of data, lack of independence in assessment procedures, restrictive use of the principle of substantial equivalence, and other shortcomings. Observation: In compiling its report on GMOs, the Royal Society of Canada s Expert Panel was unable to obtain access to the scientific data that inform CFIA and Health Canada decisions. In other words, the scientific community in Canada is not in a position to pass judgment on the scientific validity of the process, and this contributes to the general public s lack of confidence in the state system responsible for assessing GMOs. In drawing up the present report, the Conseil de la science et de la technologie had neither the time nor the means to verify whether the criticisms of the federal bodies are well founded. Other recent reports, like those of the Canadian Biotechnology Advisory Committee (August 2001) and the Ontario Public Health Association (November 2001), however, echo many of the criticisms and recommendations of the Royal Society of Canada Expert Panel. The government of Québec has a certain flexibility of action when it comes to farming, food and environmental regulation. It also has significant responsibilities in the area of public health. There are environmental particularities of Québec s territory, and cultural specificities of Québec society, that justify social choices distinct from those made in other Canadian provinces. The government of Québec is currently preparing a report on the fallout from the Cartagena Protocol on Biosafety, which establishes a number of rules for transboundary movement of living modified organisms (including GMOs). In addition, the Québec Environment Ministry is considering setting up a management framework, in collaboration with other ministries, on the environmental risks associated with biotechnologies and GM

7 products in Québec. As well, the extent to which GMOs should be used in food for human consumption is a source of public controversy: there is debate between groups in favour of GMOs and those opposed to them. Both individual and collective preferences and values are at issue. GMOs raise ethical questions. The new Commission de l éthique de la science et de la technologie, created in the wake of the Québec Policy on Science and Innovation, has decided to make the ethical issues surrounding GMOs its first order of business, and work is slated to begin early in The results of several surveys conducted in recent years paint a portrait of the main concerns expressed by the Québec population about GMOs. Quebecers want to be able to decide for themselves whether they wish to consume such foods. There is strong consensus around the issue of labelling. The need for reliable sources of information is another major concern. Issues for Québec Without prejudice to any of the orientations or decisions that Quebec society may adopt with regard to the question of GMOs, the issues and recommendation that follow presuppose that GMOs will be part of the Québec agri-food landscape for at least the next few years. Scientific issues 1. Quebec expertise in the scientific fields related to GMOs, other farming technologies, and associated biotechnological fields The shortcomings noted with regard to knowledge of genetically modified products, as well as their potential health and environmental impacts, are cause for concern in Québec as well as in other societies. Research in these areas has provided, and must continue to provide, impetus for an international scientific effort. Scientists in Québec and Canada are taking part in this worldwide effort; research activities and the training of researchers in Québec and Canada must continue to push the envelope of knowledge in the area. Québec must maintain an active presence in the various basic sciences related to our understanding of living organisms and their functions, among them genetics, genomics, cellular and molecular

8 biology, proteomics, biochemistry, physiology and ecology. It must also play a role in international efforts as regards all aspects of transgenic procedures and their health and environmental impacts. Research into the impacts of genetically modified plants must not be restricted to the food industry. Environmental studies are also required in related fields in which transgenesis is practised e.g., tree planting, and the use of transgenic plants as bioreactors for purposes of pharmaceutical and industrial production. Québec must ensure that it is present in the various fields of basic research related to the advancement of knowledge about agri-food, to improvements in the assessment of the impacts of transgenesis, and to the question of screening tests. It must also maintain and develop expertise in plant biotechnology in fields of application other than that of GM foods. This is the case, for instance, in the forestry industry, which is of pivotal economic importance to Québec. 2. Research in areas of interest more specific to Québec In addition to playing its part in international scientific efforts, Québec must see to the advancement of research into the environmental impacts of transgenic crops and other farming technologies on ecosystems within its territory. The growing of transgenic varieties of crops in Québec takes place in an agricultural, climatological and ecological context distinct from those of other regions of Canada and those of the United States. A certain Québec specificity is also apparent in another area of research: that of socioeconomic studies. These include behaviour studies of production methods, eating habits and preferences (values, attitudes, lobbying), environmental matters, risk perception, and so on. Social issues 1. Reliable, publicly accessible information on GMOs Surveys show that the public eagerly seeks information on all of the issues surrounding GMOs and their health and environmental impacts. In a context of controversy like that

9 existing with respect to GMOs, it is vital that citizens be provided with impartial, up-to-date basic information on the subject, from the life sciences as well as the humanities and social sciences perspectives. Public authorities and the media have a responsibility to ensure that the public has available to it information that is scientifically valid and presented in an impartial, clear and accessible manner. 2. Public consultation that would allow Québec society to express its preferences with regard to GMOs and to play a part in the decision-making process Québec must make its own choices as far as production and consumption of GMOs are concerned. Those choices must take into consideration the evolution of all facets of the question on the international scale, but must stem mainly from informed, thoroughgoing public debate on the options available to Québec society. Given a context marked by scientific uncertainty and social controversy, properly structured, equitable public consultation must take place that will enable citizens to express their concerns and preferences regarding the various options available with regard to GMOs, particularly as concerns: the availability of GMOs within the food trade and, if applicable, the quality and quantity of information available on products that consumers would like to see (labelling); opportunities (or lack thereof) to support the development of new GMOs in Québec; what role governments should play in the issue, e.g. in terms of risk management. Economic issues 1. Evaluation of the economic interest of current GMOs as well as other production technologies, for both producers and consumers in Québec Assessing the economic issues that GMOs may represent for Québec is difficult. The profitability of Québec-based transgenic production (corn, soybeans, rapeseed) has yet to be studied; nor has there been any analysis of their costs or their comparative advantages with respect to other technologies. Québec is not a major producer of GMOs. Of the three species subjected to transgenic production, only soybeans are exported to any great extent.

10 Better knowledge of the economic impacts of GMOs will be achieved by placing in context the effects of the other agricultural technologies they are supposed to replace. Only by evaluating the risks and benefits of GMOs in and of themselves, but also in relation to other production technologies, will it be possible to gauge their true economic interest. Other economic aspects bear close examination in the Québec context: the costs associated with labelling and with setting up a traceability system; the structuring effects of GMOs on the overall agri-food system; the economic implications of intellectual property in the case of transgenic produce; opportunities to develop certified GMO-free channels in certain markets; distribution of technology-derived profits among stakeholders (biotech firms, farm producers, consumers and others), and so on. 2. International economic intelligence Currently, the future of international GMO markets is still unclear. The European Union is expected to lift its de facto moratorium by the end of 2002 and implement a new regulatory framework. Other markets, such as Japan, remain for all intents and purposes closed to the importing of GMOs. The enforcement of the Cartagena Protocol on transboundary movement of LMOs (living modified organisms) will have to be closely monitored, as will changes in international rules of trade. In this context, new opportunities to develop certain markets may present themselves for both GM and non-gm products. Options remain open, and should be submitted for public consultation. Québec must gather economic intelligence on the progress of the food trade and the role of GM foods therein, so as to capitalize on any opportunities to develop particular systems for certain markets (whether GMO or non-gmo) that may present themselves. Political issues 1. Protection of public health and the environment by bodies responsible for certification of GMOs

11 It is vital that Canadian assessment procedures be perfectly thorough, marked by transparency and accountability, and credible. Approval of novel transgenic organisms and of their use for human food and animal feed must be subject to thorough scientific assessment as to their potential impacts on the environment and on human and animal health. Québec must obtain assurances from the federal government that the bodies involved the CFIA and Health Canada fulfill their obligations with the required competency, thoroughness and transparency/accountability, and that they possess the necessary scientific and financial resources to do so. Québec must request, among other things, that: a system be set up to conduct comprehensive, long-term testing of the ecological impacts of biotechnology-derived products that pose a potential threat to the environment, e.g. as regards the persistence of an organism or of a product stemming therefrom, persistent effects on biogeochemical cycles, and harmful effects stemming from horizontal gene transfer and reproductive selection; impact assessment should deal not only with farm ecosystems, but also with natural and stressed ecosystems in regions where such crop production is foreseen; all tests and protocols chosen for assessment of new GMOs be reviewed by independent experts; greater standardization of certification tests and procedures is achieved; the functions of technology promotion and monitoring be performed not by the same bodies, but independently of one another; the scientific data required for authorizations be periodically submitted for peer evaluation and made available to the public. 2. Strengthening of expertise and strategic intelligence with regard to GMOs within the government of Québec The Québec government is responsible for developing its own expertise relative to GMOs in the food industry and in their other areas of application. It must be able to rely on its own

12 advisors for guidance as concerns the strategic issues related to all aspects of the question: scientific, economic, legal, ethical, political, and so on. Some ministries, like the Ministry of Agriculture, Fisheries and Food (known by its French acronym MAPAQ) and the Ministry of the Environment (MENV) have set up small teams to this end. GMOs are also of concern to other ministries and public bodies; a partial list includes the Ministry of Research, Science and Technology (MRST); the Ministry of Health and Social Services (MSSS); the Québec National Public Health Institute; the Ministry of Relations with Citizens and Immigration (MRCI); the Consumer Protection Office; and the Ministry of Industry and Commerce (MIC). Each of these bodies, within its respective jurisdiction, must ensure that it can rely on internal core expertise as well as periodically call upon outside experts who are independent and credible. These bodies must also work together and exchange information continually. Developing such Quebec-based expertise is an essential condition for monitoring the international progress of the GMO issue in all its dimensions, as well as for supporting potential lobbying of the federal government by Quebec interests. This expertise is also required for the development and implementation of measures compliant with any broad consensus that may emerge from Quebec society regarding the management of GMOs on Québec territory. Ethical issues A number of ethical questions are raised with respect to GMOs in Chapter 5 of the Conseil s full report; they include: the legitimacy of human intervention; specific choices with regard to risk assessment and management; foundations of and methods for resolving controversy; concentration within the seed industry; the patentability of living organisms; equitable allocation of costs and profits; reconciliation of collective and individual interests; and so forth. While the Conseil is aware that it has barely scratched the surface of the question, and so does not presume to predict the key issues where Québec is concerned, it does consider this question as being extremely important. The work of the Commission de l éthique de la science et de la technologie on the ethical

13 aspects of GMOs is expected to make a major contribution to discussions on the subject in Québec. Recommendation The mission of the Conseil de la science et de la technologie is to define, in an integrative, thorough and critical manner, objectives and means for the advancement of science, technology and innovation that will benefit Québec society. 1 In the case before us, exactly what is in the public interest with regard to GMOs has yet to be clearly delineated within Québec society. The Conseil believes that it is too soon to issue an official position on the subject. For this reason, and so as not to influence the outcome of the consultations expected to take place shortly, it is making only one recommendation. More specifically, it suggests benchmarks that the government of Québec might use as the foundation for a systematic approach to defining its orientations as regards the production, movement and consumption of GMOs. Thus the Conseil de la science et de la technologie recommends: That the government of Québec adopt a transparent, accountable and democratic approach to managing the issue of GM foods, focussed on acquisition and sharing of knowledge as well as public participation, and encompassing at a minimum the following five components: 1. Support for the recruitment and development of Québec-based expertise in the scientific domains related to GMOs, including: a) the short- and long-term environmental impacts of GMOs produced and experimented with on Québec territory; b) the impacts of GMOs on the health of humans and animals; and c) the social, ethical, legal, economic, political and cultural aspects of GMOs. 2. Public dissemination of reliable, scientifically valid information on GM foods that covers the scientific, economic, social, ethical and other aspects of the question. 3. A public consultation process to pinpoint issues, identify concerns and build

14 consensus in Québec society as to the broad guidelines to be adopted with regard to GMOs. 4. Establishment of an intelligence-gathering system in collaboration with government and non-government partners to monitor the progress of all facets of food biotechnology worldwide. 5. Lobbying of the federal government to ensure Canada s GMO authorization apparatus is subjected to comprehensive, impartial assessment and that all necessary corrective actions are taken, if need be, to ensure the protection of citizens health and of the environment. Suggested means Establishment of a program to support research (e.g. concerted action type), through Québec s three subsidy funds, into environmental, sanitary and socioeconomic assessment of GM plants (including silviculture) in the agri-food industry and in the other areas of application of transgenic crops. Joint intervention on the part of the MRST, its Québec ministerial partners, universities and the federal government to ensure that Québec-based researchers benefit from the infrastructures necessary for experimentation and assessment of the impacts of novel agricultural products and procedures, under conditions of maximum security as far as the environment and health are concerned. Analysis of the supply of and demand for qualified human resources in disciplines related to the advancement of knowledge in agri-food and in GMO impact assessment, with a view to making the necessary adjustments that will enable Québec s academic institutions to supply the skilled resources that Québec needs. Constitution of a panel of experts to gather and validate information about GMOs to be made available to the public, with the participation of popular science writers as mediators; such public dissemination of information should be a prerequisite to any consultation on the topic.

15 Public consultation on issues such as the labelling of GM foods and its implications for the overall agri-food system, and the relevance (or lack thereof) of government support for the development of new GMOs for Québec. Establishment of a watchdog body whose main purpose would be to ensure the gathering of intelligence on all of the issues related to food biotechnology, but which would also respond to requests for information from the public, the government and other stakeholders. This body would have to display all the qualities required to fully exercise its twofold mandate: independence, credibility, impartiality, sufficient funding, and so on. Strengthening of the core expertise already in place within the various ministries concerned with GMOs to varying degrees, for the purposes of gathering their own strategic intelligence. 1. Conseil de la science et de la technologie, Plan stratégique , Sainte-Foy, p. 10 [free translation].

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