Regulation of Genetically Modified Food: A Submission to the Canadian Biotechnology Advisory Committee Dennis R. McCalla, PhD, Richard M. Beames, PhD, Hugh Lehman, PhD, and Bert R. Christie, PhD.1 http://www.rsc.ca/foodbiotechnology/indexEN.html April 17, 2001 INTRODUCTION The CBAC has asked for responses to its Consultation Document 2001 (Regulation of Genetically Modified Food). Although reference is made to the recent Report of the Royal Society of Canada’s Expert Panel on Food Biotechnology in a sidebar on p. 2 of the Consultation Document, the Document itself makes no mention of the carefully considered recommendations of the RSC Expert Panel. These recommendations are highly relevant to the questions asked in the CBAC’s Consultation Document. We have chosen to respond by commenting first on some aspects of the RSC Expert Panel’s Report followed by a critique of the Consultation Document itself. PART 1: COMMENTS ON THE REPORT OF THE ROYAL SOCIETY OF CANADA’S EXPERT PANEL ON FOOD BIOTECHNOLOGY We believe that the general analysis and recommendations of the RSC Expert Panel 2 are sound and that substantial changes are needed in the current Canadian regulatory approach to genetically engineered organisms. The remarkable parallel between the conclusions of the RSC Expert Panel and those of the EU-U.S. Biotechnology Consultative Forum (Note 2) adds to the credibility of the Expert Panel’s views. We trust that the work of the CBAC over the next few months will reinforce the conclusions of the RSC Expert Panel and that Government of Canada will make the changes recommended by the Expert Panel. Specific Comments 1.1. The Knowledge Base: The RSC Expert Panel concludes (p. 132) that the knowledge base available for understanding transgenic organisms and their effects on health and on the environment is very limited. Research on a variety of topics is urgently needed to build better evaluation capability (p. 186) and to understand food safety (p. 48) and environmental impacts (p. 133). There is little incentive for the commercial developers of GE products to engage in (or support) research designed to reveal possible hazards of the products they are so vigorously promoting. The RSC Expert Panel recommends (6.9 on p. 135) that, subject to rigorous peer review, funds should be made available to scientists from all sectors (industry, government and university) for research on the environmental impacts of GM plants. Given the need to maintain the integrity of the science, it is also important to encourage qualified independent scientists to pursue such studies, as well as studies on food safety, in an atmosphere totally free from potentially inhibiting commercial influence. Therefore, academic scientists should not be required to have the support of, or partnerships with, industry to be eligible for grants. We therefore urge that funding be made available to totally independent scientists who put forth quality proposals, as judged by a rigorous peer review process, for studies on the impacts of GE organisms and food. Again, it is essential that such proposals be judged on their scientific merits by "peers" who are not in the employ of, or otherwise supported by, biotech corporations. 1.2. Scientific Integrity and the Modus Operandi of the Regulatory Agencies: Central to the proposals of the RSC Expert Panel is a change in the philosophy of regulation and in the testing procedures on the part of the Canadian agencies. In addition, the Panel recognizes the need for more test data on GE crops and food as well as the need for "transparency" in the regulatory process. Those who have done scientific research and/or testing know that there are many pitfalls and that constant vigilance is needed to prevent bias (unconscious or not) from affecting the conclusions reached . Even with the best will in the world, errors are made in experimental design and methodology and, from time to time, workers make serious mistakes which go undetected and eventually result in inaccurate publications. In addition, there is a low level of fraud. However, in spite of these lapses, science has been largely self correcting. Peer review prior to publication, though far from perfect, is the first line of defence. Methods, data and interpretations presented in the manuscript submitted for publication are scrutinized by knowledgeable reviewers who may recommend acceptance of the paper, acceptance after some modification or, if the paper is not up to the appropriate standard, outright rejection. The second and more important line of defence against serious error is the reality that new and novel results can be checked by other laboratories. Indeed, only when such verification has occurred are new results widely accepted. Unrepeatable results are identified and untenable interpretations modified or rejected. This open and competitive process also encourages a high degree of self discipline among researchers and their staff, all of whom have a stake in ensuring that only sound work is submitted for publication. Contrast these features of traditional scientific research with the Government’s apparent expectations for "regulatory science". The data on which decisions are made are provided by the applicant which is naturally eager to have its product approved. Data are then judged by regulators who work in the very Government Departments which are engaged in the promotion of Biotechnology. (In fact, the Consultation Document (p. 8) explicitly acknowledges that Agriculture and Agri-Food Canada, the same Department responsible for the Canadian Food Inspection Agency, " has a clear mandate to promote agricultural biotechnology and international trade in agricultural commodities"). There is no provision for any independent replication of the tests. Further, the applicant may (and seemingly, generally does) declare that the data provided are to be regarded as confidential business information so that they cannot be made available for scrutiny by outside scientists. Thus, neither the experimental design, statistical power or degree of replication can be judged by other scientists. Quite aside from the difficulty in understanding why the safety data for any proprietary GE crop or food should be regarded as confidential, this has at least two unfortunate effects. First, it prevents any input from experts in the wider scientific community and second, it removes much of the discipline of traditional science. In fact, the RSC Expert Panel indicated that, in the one case to which it had access, the quality of the data submitted was scientifically inadequate for either a rational regulatory decision-making process or for a peer reviewed publication (p. 215). Further, Stuart Laidlaw, writing in the Toronto Star (Jan. 23, 2001) states that the Canadian Government approved a new line of genetically modified potatoes despite "extremely poor'' field tests that federal inspectors feared would undermine the legitimacy of Canada's regulatory system. If true, this is another serious indictment of the process and makes a mockery of the regulators’ claims for thoroughness and integrity. The RSC Expert Panel’s finding that the regulators show a great deal of concern for "maintaining a relationship of trust between industry and the regulator" comes as no surprise. However, there does not seem to be a similar degree of concern to maintain the trust of the Canadian public, including independent scientists! Requests for information have been rebuffed and criticism of regulatory policies and actions have been met with derision and hostility. Indeed the situation gives credence to Ursula Franklin’s declaration that, "... in fact, we have lost the institution of government in terms of responsibility and accountability to people. We now have nothing but a bunch of managers, who run the country to make it safe for technology." Full implementation of the RSC Expert Panel’s recommendations on pages 191 and 206-7 plus the earlier detailed recommendations regarding testing would go a long way toward remedying the situation. We believe that the regulators should not accept data which does not meet the standard set by first rate, peer reviewed, journals. To achieve the necessary openness and transparency, the detailed scientific results on which regulatory decisions are made must be readily available to interested parties - preferably in the form of actual peer reviewed articles in the scientific literature. Pending the appearance of such articles, detailed scientific reports should be published electronically on the Agency’s web-sites. Likewise, all other relevant information which is not published should be available on the web-site. In this era of cheap electronic communication it is not acceptable merely to make data available for perusal at the headquarters of the agency. The magnitude of the changes required to implement the RSC Expert Panel’s recommendations on the regulatory system should not be underestimated. Indeed, a complete change of attitude on the part of the regulators is needed. Such change will require inspired leadership and will not occur if the Departments involved are allowed to retain their dual and conflicting roles as regulators and promoters of biotechnology! One approach would be to create a Ministry whose sole job it is to assess the acceptability of our crops and food, including those produced by genetic engineering. Whatever new system is put in place it will serve the public interest effectively only if sufficient resources are provided and if the staff members involved are treated as professionals by management. Indeed, the difficulty of attracting top notch scientific talent to the regulatory agencies in the face of blandishments from industry and academia should not be underestimated. Again, there is evidence that radical change is needed. Health Canada has been in conflict with staff scientists. To cite a recent case, Dr. Shiv Chopra, a Health Canada scientist, was suspended after speaking out about problems in that Ministry. On March 13, a court cleared Dr. Chopra of all allegations of misconduct. Health Canada was ordered to rescind his suspension, to return to him the one-weeks' pay that was deducted, and to remove from his file any reprimands. The judge declared that Dr. Chopra was justified in speaking out about the problems of Health Canada for the sake of the public interest. Federal legislation to protect responsible whistle blowers from repercussions by superiors who have been compromised by undue political pressure is badly needed. There should be provision for periodic in-depth review (perhaps every three years) of the Agency to ensure that the quality of its work is appropriate and that new regulatory challenges are being met. Perhaps a Parliamentary panel advised by a group of independent scientists and consumers would be appropriate. 1.3. Special GE-plants for the Production of Nutraceuticals, Vaccines, Enzymes, and Industrial Chemicals: The RSC Expert Panel describes briefly the prospects for the introduction of GE plants modified to produce a variety of products (p. 21). Some of these will be engineered to have enhanced nutritional value. Others will produce vaccines and various pharmaceuticals and still others will produce enzymes or industrial chemicals. If open pollinated food crops are used, there is every possibility that the pollen from the GE plants will transfer the engineered genes to non-GE crops which are destined for human consumption. Spillage of seed or dispersion of seed by the wind will likewise cause contamination. Also, given the demonstrated contamination of the human food supply with Starlink corn, a variety approved for livestock feed but not for human consumption, it is reasonable to expect that such special GE products will inevitably enter the food chain directly through error. While the RSC Expert Panel did recommend that approvals should be given for GM products with human food counterparts only if they are themselves acceptable for human consumption, it really did not grapple with the problem posed by the developments it described in the introductory chapter. It seems to us that there are a number of important issues that require regulation. 1.3.1. In the case of plants engineered to produce pharmaceuticals, enzymes, industrial chemicals and the like, food crop plants should not be used unless it can be established beyond all doubt that these products are safe (as might be the case of a plant producing a chemical which is already consumed at comparable levels by humans). The reason: there is a very high probability that the human food supply will become contaminated. Only species that are not consumed by humans or by livestock should be permitted for the production of these substances. 1.3.2. The situation with vaccines and nutraceuticals is more complex. With the former, the object may be to produce food which contains an "oral"vaccine for direst administration to humans and domestic animals. If so, crop plants will be used. Existing Food and Drug regulations will presumably deal with both the efficacy and safety of vaccine-bearing foods for their intended recipients. Ideally, food derived from such varieties would be consumed only by those in need of the vaccine However, given the near inevitability of the introduction of these materials into the general food supply, much wider exposure to some level of the vaccine seems inevitable. The inadvertent administration of a vaccine, or a variety of different vaccines, to large numbers of people including the very young, the elderly and the sick as well as to livestock and wildlife, needs wide discussion and very careful consideration. With nutraceuticals there are even larger issues. These products will be engineered to confer a supposed advantage such as a higher level of some essential nutritional factor, oils having more desirable fatty acid composition and so on. We can be sure that the proponents of these products will promote them vigorously with strong claims for their efficacy. There are at least two problems to consider. The first is the matter of the pollution of other food through inadvertent contamination of the corresponding non-GE food as was discussed above. Such plants should be grown in strict quarantine until their safety, both for human health and the environment has been established. The second issue has to do with the need for some responsible body to examine and certify the claims that will be made for the benefits of these products. Otherwise, one can anticipate a plethora of exaggerated and misleading claims (genetically modified snake oil?). The CBAC should recommend that a rigorous process to approve the claims that are being made for nutraceuticals be put in place by Health Canada. Again, the studies supporting the efficacy of these products should be made public as a matter of course. 1.4 Labelling: The RSC Expert Panel has accepted the notion that voluntary labelling of products derived from GE organisms should suffice. In this its conclusions differ from those of the EU-U.S. Biotechnology Consultative Forum which stated (p. 15), " The consultative forum considers it of importance that consumers are informed truthfully and adequately about genetically modified food products. Labelling of genetically modified food products is an important tool in providing customers with relevant information." We believe that the Forum has it right - it is a simple matter of consumer justice that individuals can determine if the food products they are considering contain material from GE organisms. Having said that, it should be emphasised that the Expert Panel’s recommendation to develop a scheme of voluntary labelling for GE products (pp. 220-228) is predicated on the assumption that recommendations regarding testing and management of risks presented elsewhere in the Report are fully (emphases in the original) implemented. The Report is silent on the issue of what sort of labelling should be required if the response to these other recommendations is unsatisfactory. In our view, unless the public can be assured through more stringent testing requirements plus public disclosure of the results, that truly meaningful steps have been taken to test products derived from GM organisms, strict mandatory labelling should be required. This is a matter of simple consumer justice: people should know when they are being presented with inadequately tested food derived from new and unproven technology. The CBAC must deal with this issue in a very forthright way so that the Government cannot, on the one hand, fail to accept the recommendations regarding the need for better testing while at the same time accepting the recommendation to implement only voluntary labelling. 1.5 Other Crops: While at this stage of its work, the CBAC is concentrating on GE food, there are rapidly developing issues involving other plant crops that need immediate attention. Three of the world's largest paper and lumber producers have formed a joint venture, called ArborGen, that hopes to be the first group to commercialize genetically modified trees. GE tree species having increased growth rates, herbicide and insect resistance and reduced levels of lignin are being developed. ArborGen expects to seek approval from the U.S. Department of Agriculture and other regulatory bodies for mass planting by 2005. The Canadian Forest Service describes itself as the largest Canadian organization involved in forest biotechnology. It reports success in introducing novel genes into several species of conifers and is working on the creation of pest and herbicide tolerant varieties. It is also working on genes for flower sterility. Such GE tree crops raise a number of very serious questions In particular, the issue of gene flow from GE tree crops into their wild counterparts needs very careful examination. Gene flow takes place most extensively in situations in which GE crops are open pollinated and have wild relatives in the same location - something that will occur with most proposed GE tree crops. Unless these varieties are effectively segregated from their wild counterparts, flow of the engineered genes into wild trees is inevitable. The effect of such genes on the wild species and ultimately on the ecosystem is totally unknown. Prudence dictates that GE tree varieties should not be allowed where there is the slightest chance of contamination of their wild counterparts. It has been proposed that sterility genes be used to prevent or limit gene flow but this untested technology has serious limits. As well, introduction of sterility genes may have profound effects on forest species and ecology. Given the imminence and importance of these issues, we trust that the CBAC will soon turn its attention to this matter if it has not already done so. PART 2: COMMENTS ON THE CBAC CONSULTATION DOCUMENT. While the CBAC has worked hard to try to present itself as operating in an unbiassed and open manner, the Consultation Document contains seriously misleading statements that force us to question the objectivity of the whole consultation effort regarding the regulation of GM crops and foods. 2.1. Biassed Wording in the Consultation Document: 2.1.1 The process of genetic engineering: On page 2 it is stated that,"This 'genetic engineering' is more precise than randomly creating mutations because the basis for the change is understood at both the DNA and protein level". This partial truth represents a wilfully misleading statement. While it is true that the DNA construct that is introduced into the recipient plants is generally well characterized, the actual events that lead to incorporation of the construct into the genome and its subsequent expression constitute a "black box". At present it is impossible to control the site of integration or the number of copies of the construct that become incorporated. Each transformation event is unique so that the genetically modified "daughter" plants will all be distinct from one other. Pages 18-19 and 183-185 of the RSC Report discuss this issue. More detail can be found in the report commissioned by Greenpeace Netherlands, and prepared by Amsterdam Plant Research International B.V., Wageningen, August 2000. The situation is further confounded by gene silencing and by the fact that the insertion of the new genes may affect the expression of other genes through disruption or through pleiotropic effects. The statement on p. 19 that GE organisms can be produced using "genetic material - sometimes from closely related species or from species that are distantly related or even essentially unrelated" (emphasis added) reveals a bias towards minimizing the revolutionary nature of genetic engineering. The fact is that with these techniques DNA from several totally unrelated organisms can be combined and introduced into a plant (e.g. the Bt gene from insects, a promoter from cauliflower mosaic virus, an antibiotic resistance marker from bacteria, as well as start and stop sequences, something that is totally impossible in either nature or conventional plant breeding. With traditional plant breeding, genes from the same or closely related species are introduced into a plant by pollination and then letting the natural processes of fertilization and genetic recombination do the rest. This results in a tidy, functional and stable arrangement of genes on the chromosomes. Thus, while the starting material for conventional breeding is more complex, the processes which incorporate the desired gene into new varieties are natural and precise - the product of millions of year of evolution. This distinction lies at the core of the controversy over genetic engineering. By failing to acknowledge this, the Consultation Document reveals a serious bias on the part of its authors. This section of the Consultation Document also leaves the impression that conventional breeding is solely based on "mutation breeding" or mutagensis. This is incorrect - much of the new genetic material for improvement of domestic plants has come from genes that exist naturally in other lines of the same plant, in their wild ancestors or in other relatives that are sufficiently closely related that they can be crossed. As has been pointed out by Stoskopf et al., mutation breeding is a supplement to conventional hybridization methods, and is used only in special circumstances - primarily in self-pollinated and vegetatively propagated plants. Also, since the existence of induced mutations was not recognized until the work of Muller in 1927, mutagensis breeding cannot have been used "since the beginning of the 1900s"! What is one to make of this? At best it shows a careless approach to the writing of the Consultation Document; alternatively it can justifiably be taken to represent a deliberate attempt to minimise the differences between conventional plant breeding and GE with the hope of making the latter seem less radical. In neither case does it enhance the credibility of the CBAC. 2.1.2 The description of the regulatory process: The account of the development of procedures for the regulation of GE foods and crops on p. 3 of the Consultation Document states,"These principles were formulated to ensure (emphases added) that the practical benefits of biotechnology products were balanced with the need to protect the environment, human health and safety". This whole section is written in a way that implies that the efficacy of the approvals system is accepted by the CBAC. However, given the weaknesses of the current regulatory system as explained in the Report of the RSC Expert Panel, it is clear that risks of harm to people and livestock and to the environment from GE plants have not been given their proper weight in decisions to permit the introduction of GM-crops. The assertion in the Consultation Document that, "...there are opportunities for improving the efficiency, effectiveness and public understanding of the system" is wishy-washy to say the least. 2.2 Ethics of the insidious approach to the introduction of GE food: With all the apparent emphasis of the CBAC on ethical considerations, the Consultation Document completely misses the most relevant ethical question of all, namely, was it ethical to introduce the products of an unproven technology like GE plants without prior public discussion of their acceptability or any indication to the public as to which specific items are products of the technology? The rationalization often used is that GE products are deemed to be "substantially equivalent" to their non-Ge counterparts. However, this concept is vague and, as a series of recent reports, including the RSC Expert Panel Report (p. 177 and following), makes clear, this is an assumption, not an experimentally verified fact. In our opinion, the introduction of GE crops and foods without genuine public disclosure and informed discussion was clearly unethical in that it deprived citizens of any choice in the matter of accepting or rejecting the products of agricultural biotechnology. The situation is particularly repugnant in that the benefits of the initial GE crops accrued to the multinational corporations and perhaps to some growers but (unlike the products of medical biotechnology) did not directly benefit the consumers who were the ones at risk for any untoward health effects. A parallel situation would be a decision to fluoridate a community’s water supply without telling the populace, something that would clearly be unacceptable even if evidence supports the safety and efficacy of the measure. Alternatively, the surreptitious introduction of GE foods, could be likened to a physician using treatment procedures without the knowledge or consent of the patient. Similarly, GE crops have impacted growers of conventional crops such as canola, corn and soy because their non GE varieties have become contaminated with pollen or seeds from GE crops with the result that major world markets have been closed to them. Again, this occurred without any real and informed discussion within the farming community of the possible problems that GE crops would pose. Also, completely missing from the Consultation Document is any recognition of the issue of liability. As has been demonstrated by the widespread contamination of the western Canadian canola crop and by the Starlink corn debacle in the U.S., it is quite unclear who is liable in the event of problems. Transgenic agriculture necessarily externalizes costs and risks involuntarily and unavoidably in the form of both genetic pollution and post-harvest mixing. Because these effects are inevitable, it is unconscionable to penalize those whose livelihoods have been compromised by unavoidable contamination. The view has been expressed that the surreptitious introduction of GE crops and foods was a deliberate act designed to contaminate the food chain irretrievably with GE products before the public became aware of what was being done and thus preempt public involvement in decision making. Whether or not this is true, the history of the industry and its regulation does leave open this interpretation. The Consultation Document makes reference to the concern of "others" that, as a result of mandatory labelling of GE foods, people may be "denied" beneficial products because of consumer rejection. We read this as saying that the consumer may choose not to buy something if he/she knows what is in it. It is remarkable that persons and corporations that otherwise vehemently champion free market principles should suggest that basic information needed for consumers to make informed choices should be withheld because sales might be affected if people knew what they were getting! 2.3. Communications: It has been our experience that "poor communications" are often invoked as a means of deflecting attention from more fundamental problems. Thus, while Health Canada and the CFIA could undoubtedly improve the way they communicate with the public, this is not the basic problem. As noted above, the Agencies’ whole approach to their tasks needs to be reformed along the lines suggested by the RSC Expert Panel. Simply explaining in a more elaborate way what is being done now will not help to instill public confidence and will be a waste of resources. 2.4. "Unknown Unknowns": The Consultation Document reads as if all of the information needed to reach scientifically valid conclusions regarding the risks and benefits of GE crops and foods is attainable. However, given the complexities of cellular processes on the one hand and of the ecosystem on the other, coupled with our profound ignorance of both these areas, no such firm conclusions are possible. There are, to use Thomas Homer-Dixon’s term, "unknown unknowns". Further, there are some serious Catch-22 situations involved. For example, it is impossible to judge with certainty how a GE crop will behave in the wider environment by means of confined experiments, yet once the crop is released into the environment for study there could be irreversible effects. While there are those who argue that the likelihood of grim, irreparable environmental effects is very small, it is also recognized that the impact of such events, should they occur, could be very damaging. Future basic science discoveries will help to narrow the range of our ignorance but complete predictability will never be achieved. Meanwhile, there is the unresolved question of liability in the event of harm. Past experience with the deleterious side effects of technological developments3 (Note 3) should be sufficient to induce a state of humility and to sensitize us to the inevitability of serious unanticipated problems. However, it is clear that many of the corporate and technological elite reject this view. Perhaps this is only to be expected since those who are pioneering a new technology are dazzled by the exciting intellectual adventure in which they are caught up and in which they may have a substantial direct or indirect financial stake. For scientists and regulators to reject a precautionary approach and to assume that they are now so much better informed than their predecessors as to be infallible, is arrogance. For the public to accept such nonsense is folly! CONCLUDING REMARKS We recognize that the remit of the CBAC is to make recommendations on biotechnology. There is, however, need for a balanced approach to the solution of the problems confronting agriculture and the food industry. It is by no means clear that biotechnology will provide the best solutions. This was recognized by the RSC Expert Panel who point out (p. 29) the need for a much broader research agenda which would look at systems and methods of sustainable agriculture so that society will be able to make informed choices between alternate approaches to food production. This seems to us to be a wise recommendation - one that any prudent civilization would embrace. Yet, in the developed countries both governments and business are putting a disproportionate share of research resources into the development of agricultural biotechnology to the detriment of other approaches. Is it rational for society to devote an increasing proportion of its scarce scientific resources (including academic researchers) to biotechnology or would some of them be better applied elsewhere? We believe that support for research on a variety of non-proprietary agricultural topics should receive increased public support. Industry will continue to fund potentially lucrative areas such as biotechnology but progress in other equally important areas is completely dependent on public funding. -------------------------------------------------------------------------------NOTES 1. The authors: Dennis R. McCalla, PhD (biochemistry and genetics) 1961 from the California Institute of Technology; Faculty Member, McMaster University 1961 to 1989. Dean Faculty of Science, 1967 to 1975, Vice President Health Sciences, 1982 to 1989. Over 90 peer reviewed publications in biochemistry and genetic toxicology. Served on NSERC and NCI grants panels. Chairman of the Ontario Council on Occupational Health and Occupational Safety, 1984 to 1989. Dick Beames, Ph.D. McGill University (nutrition), 1965. 1954-1968, Husbandry Officer, Queensland Department of Primary Industries. 1968-1996, Faculty member, Department of Animal Science, UBC. Past President, Canadian Society of Animal Science (1976); 1976-1989, member CUSO Canada-Cuba team to improve pig production in Cuba; Over 60 peer-reviewed papers in scientific journals and three book chapters on animal nutrition and food evaluation and analysis. Hugh S Lehman, Ph.D. (Philosophy), Harvard University, 1963. Facultymember, University of Guelph, Guelph, Ontario, 1969-1996. Author of Rationality and Ethics in Agriculture, (University of Idaho Press,1995). Co-editor of: The Pesticide Question: Environment, Economics and Ethics, (Chapman and Hall, 1993) and The Journal of Agricultural and Environmental Ethics, (Kluwer Academic Publishers), 1988 - 1998. Bert Christie, PhD, 1959, Iowa State University ( Plant Breeding, Genetics and Biometrics). Faculty member, 1959-1989 Faculty of Crop Science Department, University of Guelph: 1989-1998 Research Scientist, Agriculture and AgriFood Canada, Charlottetown, PEI. Author or co-author of over 90 scientific papers in peer reviewed journals; Editor or co-editor of 3 text books; developed 10 cultivars of forage crops. Past President, Canadian Society of Agronomy, Honorary Life Member, Canadian Seed Growers' Association, Agcellence Award, Agriculture and AgriFood Canada. 2. The EU-U.S. Biotechnology Consultative Forum: This 20-member group including scientists, business executives, farmers, environmentalists and ethicists (including Norman Borlaug, Nobel Prize winner and "father of the green revolution"), was established in May 2000 by President Clinton and President Prodi of the European Commission to,"provide a consensus report reflecting their views and assessments of the benefits and risks" [of biotechnology]. In mid December of last year, the group issued its final report. This report is comprehensive, candid, and balanced. Its opening paragraph sets the tone for the remainder of the report: "Modern biotechnology holds the promise of dramatic and useful advances in some of the areas of greatest challenge for humankind during the 21st century. Like all new technologies, it also holds risks, both known and unforeseen. In the absence of broadly acceptable and open consultation processes, discussion about the issues has become polarized." The Report then presents a detailed analysis of the benefits, risks and uncertainties that are involved with plant biotechnology. The response of the U.S. Government is worth noting. The U.S. Mission to the EU put out a "Fact Sheet" over the imprimatur of the "Office of the Spokesman, Department of State that seriously distorts the findings of the EU-U.S. Report by extracting, out of context, virtually all of the comments that support biotechnology without mentioning the Report’s statements that are critical of biotechnology, the substantiative recommendations for more rigorous evaluation of GE products or the serious questions the report asks about the current practices and applications of agricultural biotechnology. Apparently the U.S. Government is not willing to respond positively to thoughtful suggestions made by knowledgeable outside experts. A similar situation seems to exist in Canada since Canadian regulatory agencies responded to the RSC Expert Panel’s Report with a press conference at which conclusions of the Report regarding the adequacy of testing were attacked and the work of the Panel denigrated. 3. Unfortunate "Side Effects" of New Technologies: For people of a certain age, the debate over GE crops and foods evokes memories of the chemical industry in the decades following World War II. It is worth examining some of the events for the lessons they provide. In 1940 Paul Müller, working for the Geigy chemical company in Switzerland discovered that DDT, which had been synthesized in the 1890's, was a powerful insecticide. His discovery was made known to both the Allied and Axis Powers and was widely and successfully used by the military of both factions against insects and insect borne disease such as malaria and typhus. Müller received the Nobel prize in 1948 for his discovery. When the compound was made available to civilians, it was used with complete abandon. Wide areas (and their populations) were repeatedly fogged with DDT aerosols to control mosquitos. Other, nastier, organochlorine pesticides like dieldrin, aldrin and heptachlor were added to the arsenal and were embraced by farmers, gardeners and householders. A cartoon from the period shows a garden centre customer saying," I want a spray that kills everything but isn’t dangerous"! In 1962 Rachael Carson published Silent Spring, the first detailed account of the hazards of these compounds. The chemical industry circled its wagons, claiming that if DDT and other organochlorine pesticides were banned, there would be mass starvation as the insects took over! Carson was attacked unmercifully and shamelessly by spokesmen for industry who denigrated her credentials, dismissed her as one who wrote for the public rather than for scientists and as a woman who "kept cats and loved birds". Ezra Taft Benson, a former US Secretary of Agriculture, even went so far as to wonder "why a spinster with no children was so concerned with genetics"! Yet we all know the outcome: basically, Carson was right. DDT and its relatives accumulate in animal tissues and move up the food chain so that top predators carried large burdens of the compound. As a consequence, the eggs of species such as eagles, ospreys, peregrine falcons and brown pelicans failed to calcify properly, resulting in a marked decrease in hatching. By 1970 there were also reports that preparations of these chlorinated hydrocarbons caused cancer in test animals. By the end of the 1970's, developed countries had either banned these compounds or restricted their use to a few applications for which there were no alternatives. Tissue levels in wildlife and humans have now decreased and the threatened species are recovering. There are at least two important lessons here: first chlorinated insecticides acted in the environment in a way that was not anticipated, and second, the economic interests that profited from them, aided by some academic and government scientists , conducted a campaign of vilification and misinformation in what turned out to be a vain attempt to suppress knowledge of the hazards. This kind of behavior is by no means an isolated incident. Unexpected effects seem to be the rule rather than the exception when new technology is introduced. Consider the chlorofluorocarbons (CFC’s) which replaced toxic sulfur dioxide and ammonia as refrigerants and were also used as propellants in aerosol cans. By the 1970's it had become apparent that enough of these compounds had entered the atmosphere to destroy part of the ozone layer which shields the earth from the UV component of sunlight. This is undoubtedly contributing to the increased incidence of human skin cancers and, if severe enough, could even endanger the production of marine algae, an important source of food for many other creatures. Even though CFC’s are being phased out, they are slow to decompose and seasonal thinning of the ozone layer will continue for many years as material now in use continues to escape. Thalidomide was approved for use in the treatment of nausea of pregnancy in several countries. Although no birth defects were detected when this compound was tested on rats and mice it proved to cause severe limb deformities in humans. Thalidomide was not approved for use in the US - thanks to Frances Kelsey, an astute FDA official who remained unconvinced of the adequacy of the safety data provided. Margarine, produced by hydrogenation of vegetable oils was vigorously promoted as being healthier than butter. Decades later we are told that partially hydrogenated margarine may be as harmful, or even more harmful, than butter because of the trans fatty acids formed during the process. British regulatory authorities allowed meat meal produced from offal containing animal brains and other nervous system tissues to be used as an ingredient in feed, apparently assuming it would safe because the high temperature used in the rendering process would inactivate the infectious agent and also because they assumed that the agent would not cross the species barrier to humans. As we now know, both these assumptions were wrong. Prions transmitted to cattle spread "mad cow disease" which in turn caused an outbreak of Creutzfeldt -Jakob disease in humans. Even where there are no complications due to ecosystems and physiology, new technologies cause problems. Every computer and every line of code is the result of human ingenuity. Yet, even in this situation the so called Y2K problem was allowed to develop, apparently through a combination of misplaced frugality and sloth. In Canada alone, twenty billion dollars were spent to correct the problem. Jan. 1, 2000 is long gone. The Y2K "bug" did not cause serious problems anywhere in the world. Whether we were saved from a serious situation by the heroic efforts of the computer industry or simply conned into spending billions to up-grade computer systems unnecessarily, the conclusion is clear, the experts are fallible! The take home lesson from all of this is that powerful new technologies will inevitably have unanticipated negative side effects. As systems increase in complexity, more subtle and potentially more serious problems are to be expected. Some of these will be impossible to rectify.