Biotechnology Backgrounders
SUMMARY
The introduction of genetically modified foods has been accompanied by a level of concern in Europe which was not seen in the United States. This is seen as reflecting both a different cultural appraisal of risk, sensitised by the "mad cow" experience in the United Kingdom, and a desire by European farmers to protect the advantages they enjoy under the Common Agriculture Policy. The level of concern over GM foods is much greater than for GM medicines, where the benefits of the technology are more readily defended.
This Backgrounder, while arguing that risk management must build on the best possible science, draws attention to the social, economic and political aspects of the risk management process. It draws attention to the use of exaggerated claims and the misuse of the precautionary principle by the opponents of GM foods, and argues that many of the concerns about the technology reflect such factors as a sense of unease about the power of the corporations which employ it.
It argues that, like any technology, GM food carries with it both advantages and risks, and that the costs of forgoing GM plants includes environmental costs such as the greater use of pesticides. It argues for careful assessment of the risks, which (if it is to address the public concerns) must be conducted in a transparent and credible manner which builds public trust. The acceptability of risks, it concludes, depends on this as much as science, since the prevailing "culture of fear" thrives on secrecy and attempts to manipulate public opinion.
INTRODUCTION
The recent experience in the UK with "mad cow disease" or bovine spongiform encephalopathy (BSE) has engendered a particular sensitivity among consumers over what they are eating. BSE -- thought to be caused by a protein molecule called a prion -- produced the devastating "new variant" Creutzfeldt-Jacob disease (nvCJD) in humans who had consumed nerve tissue.
BSE was shocking not so much because of the scope of the problem in humans (relatively few people have contracted nvCJD), but because of the horror of the disease. "Spontaneous" CJD was best known previously among those treated with growth hormone extracted from the pituitary glands of dead humans, or as kuru in Papua New Guinea, where ritual cannibalism involved the consumption of human brain tissue. The BSE experience has fed concerns about foods which have been produced using the new technology of genetic engineering. But the way in which concerns have developed into policy responses has been markedly different in Europe than in the United States, where concern exists but has not had a significant impact on policy development. Why?
To answer that question we must delve into the process of risk assessment, whereby different political systems confronted with the same scientific evidence can reach fundamentally different positions on how to manage any particular risk. In so doing, we can also shed some light on why what the alarmists have labelled "Frankenstein food" has evoked much more concern than the use of genetic engineering to produce pharmaceuticals. In a wonderful irony, genetic engineering has, for a decade, allowed the production of a growth hormone which has avoided the risk of CJD without giving rise to any alarm. Understanding risk assessment also allows us to understand why this is so, and points towards the ways in which we should assess the risk of genetically modified organisms (GMOs).
Concerns about beef in Europe are not new. Hormone-treated beef has been in dispute between the European Union and the US since 1985, when the then European Community imposed a regulation prohibiting the sale or importation of beef raised with the assistance of artificial hormones. At that time, problems had arisen in Italy among children who consumed (European) beef which had been injected intramuscularly with hormones, while the US argued that their production methods did not give rise to the same risks, since they used hormone patches behind the ear of cattle beasts. Since the ear was not consumed, there was no chance that high concentrations of residues could find their way into meat sold for consumption. (1)
The more recent dispute has not involved artificial hormones at all, but naturally-occurring bovine somatotrophin (BST) produced by organisms which have been genetically modified. Recombinant BST (produced by bacteria whose genetic material has been modified so they will produce it) has been available for commercial use in the US since February 1994, but was not approved for use in the European Union, Australia, Canada, New Zealand and Norway. The product is produced using the identical BST synthesised by the cattle and is thus indistinguishable from "naturally-grown" beef -- itself the result of animal husbandry techniques and eons of selective breeding by humans to improve productivity. So why the concern?
Part of the answer can be gauged from the way in which other EU nations exploited Britain's BSE tragedy, in which about a million cattle had to be slaughtered. (The economic cost to the UK has been over £3 billion.) This was a bonanza for Continental beef producers, since it allowed bans on trade in British beef within the European single market and restaurants were able to advertise their steak as being "non-British" or "French Charolais". There is almost always a silver lining for someone in any such dark cloud -- but more on that later.
RISK AND NATURE
Increasingly, we care about how our food is grown and prepared. We no longer eat restaurant dishes with classic names like "steak Diane", but "rump of grass-fed yearling King Island beef, pan-fried ..." The sizzle has become at least as important as the sausage, and part of the sizzle has to do with our conceptions of nature, particularly with somewhat romantic notions of purity or the absence of contamination. "Organic" is good, despite the fact that organic chemistry has given us all those pesticides about which we are so concerned.
"Chemical" is usually synonymous with synthetic chemical, and these notions of purity extend to the bottled water we buy. It is possible to buy bottled water from the Snowy Mountains which is labelled "organic" -- somewhat absurd when the whole point of drinking bottled water is to be sure that it is absolutely free from organic substances. Similarly, the label of water bottled at a spring in Tasmania boasts that it is free of chemicals -- right beside an analysis of the calcium and other minerals it contains.
And while we are told that we should be concerned about traces of chemicals in the environment which can mimic hormones, we are increasingly drinking soy milk. This contains sufficiently high concentrations of phytoestrogens that it is recommended by some as both a natural alternative to hormone replacement therapy and as a means of preventing prostate cancer.
Our perceptions of risks and benefits, as these examples show, are almost inevitably affected by factors other than just the "objective" science describing toxicity, carcinogenicity and so on. Many of our perceptions of risk are affected by questions such as: whether the risks affect children or adults; whether they are accepted voluntarily or imposed; whether processes are secret or open; whether risks are assessed by industry or by analysts seen as disinterested; whether they involve the catastrophic death of large numbers of people or a succession of isolated deaths; the kind of deaths involved; whether the effects are immediate or delayed; and whether the risks are natural or man-made. Travelling 10 miles by bicycle in the US and living for 50 years within 5 miles of a nuclear reactor, for example, have both been estimated to yield an increased probability of death of one in a million, yet we respond to these risks quite differently. (2)
One factor which affects our perceptions of risk associated with chemicals, GMOs and drugs is the fact that these products are manufactured by large, faceless corporations, usually transnational corporations which are seen as being beyond the control of governments. As anthropologist Mary Douglas has pointed out, many of our fears about such risks reflect our sense of powerlessness in the face of such corporate giants in an increasingly globalised world. (3) But she also argues that risks are used to blame those already disliked.
This problem is exacerbated by the fact that the regulation of such hazardous substances poses problems which are tailor-made for those who would wish to amplify the risks. All typically involve intellectual property, and patent law provides for a period of monopoly to recover development costs and profits, balancing the public good of having the lower prices which competition would bring against the public good of encouraging research and development by industry. But this means that most of the research into the safety of such products is conducted either by the corporations themselves or by contract scientists or research laboratories who must be contractually bound to honour commercial confidentiality. (Patents for pharmaceuticals might offer no protection if a competitor could add to the molecule an additional but meaningless chemical element or two which might simply be removed in reaction with stomach juices, for example.) (4)
Regulators must use such science in making licensing decisions, but it is easy to construct a somewhat paranoid discourse around both the science and the scientists in such circumstances. Products found to represent a low hazard can still be claimed to constitute an unacceptable risk when most of the science can be dismissed as the biased product of self-interested industry, or of corrupted scientists who have undertaken research consultancies -- if not now, then at some time in the past. (5)
Science can be wrong. Bias is a constant problem. But science has developed means of minimising such pitfalls. It can never eliminate them completely, but the canons of the scientific method -- if followed -- can improve the reliability of scientific knowledge. The courts in the hyper-litigious US have had to rule on what constitutes acceptable scientific evidence in the face of a tendency for parties to each hire their own expert witnesses, and (not surprisingly) decided that the appropriate test was whether the information was generated by following key elements of the scientific method, such as replicability of results and publication after anonymous peer review. (6) Scientific knowledge always contains some residual uncertainty, but we have learned to place more faith in knowledge which emerges from such a process than that which appears from research which has not followed established scientific protocols.
While the source of funding might alert us to the direction in which a piece of scientific research might be biased, the appropriate test must be adherence to the scientific method. Against such science, we are often asked to be alarmed about the implications of research which has not yet been replicated and, in some cases, not yet published in peer-reviewed journals. Regardless of its source -- industry or environment group -- we should be extremely wary about acting upon such "science".
This is so even for those interest groups which profess to have the public good at heart. It has been suggested that there is a "danger establishment", consisting of scientists (especially in "grant-rich" areas of research), journalists, politicians, bureaucrats and environment and other public interest groups, which has an interest in exaggerating dangers. (7) And because many researchers and journalists are often clamouring to build support or a readership, there is a tendency for them to shout in order to be heard. We need to be aware, in other words, that bias can enter our social risk assessments from many directions, and recall examples such as the McBride case where research was found to have been falsified to exaggerate the dangers of a drug in order to secure continued funding for a research institute.
We should see Greenpeace -- even if we share its goals -- as not just an environmental group, but also as a transnational private company which licenses its trademark to thus-controlled foreign subsidiaries and which has among its informal goals that of system maintenance. Like any organisation, it has salary and operating costs to cover and it must try to retain its annual revenue base of well over A$150 million worldwide. It would be an exceptional organisation which managed to purge itself of the pursuit of goals of system-maintenance. It can therefore be expected to focus its effort in areas and ways which will heighten concern and willingness to pay (especially since it rewards fund-raising success internally with decision-making influence).
Greenpeace specialises in politicised science, often committing the cardinal scientific sin of bringing the evidence to the theory, usually in the form of dramatic visual footage supplied to the media from some remote location. Perhaps because of the remoteness and perhaps because of Greenpeace's perceived disinterestedness, news editors screen such footage when they would not do the same for footage supplied by more obviously interested sources. (At a political science conference in Christchurch last year a TVNZ news executive stated that his corporation never screened footage from sources outside the company of established news services -- except for Greenpeace!) Footage of the retreating Bering Glacier provided on the eve of a climate change conference provides powerful support for action on climate change, but science is also interested in why, for example, glaciers in New Zealand are advancing.
We can illustrate this with the problems generated by Greenpeace's politicisation of science associated with GMOs. In June 1999, France was leading the push within the EU to have the EU ban the importation of GM food. France is not regarded as an environmental vanguard state in Europe, but it is one of the strongest supporters (and greatest beneficiaries) of the Common Agricultural Policy. It was supported in this push by Greenpeace, whose members dressed as butterflies and carried a banner containing the slogan "Give butterflies a chance" to the meeting of EU Environment Ministers in Luxembourg on 24 June. Citing a recent US study which indicated that pollen from genetically-engineered Bt maize could kill the larvae of monarch butterflies, Greenpeace invoked the precautionary principle in urging a ban. The EU froze the approval process.
This piece of scientific knowledge, combined with the precautionary principle, gave considerable power to the coalition of Greenpeace and European agriculture, but it took what appears to have been sound but limited science further than it should have and ignored contextual factors completely in providing a convenient protectionist cloak.
The monarch butterfly research was published by John Losey at Cornell University in a (refereed) letter to the journal Nature. (8) Losey issued a careful press release which was totally ignored by the media (and Greenpeace), stating that the research was conducted in the laboratory and that it would therefore be inappropriate to draw any conclusions about the risk to monarch populations based solely on these initial results. The reasons for this caution are obvious when the nature of the experiment is considered. Hatchling monarch larvae were given a diet consisting solely of milkweed leaves (their sole food) dusted with corn pollen. (Older larvae might be less susceptible.) In the wild, larvae are known to avoid leaves with pollen on them and move to a clean leaf. Further, milkweed is rarely found in cornfields, because farmers avoid them at all costs; it is commonly found in pastures and old fields. Maize pollen also does not travel far: little can be found 30 feet from a cornfield and it is practically non-existent at 100 feet. Finally, the period when maize pollinates and monarch larvae feed are both very short and might not even overlap in some seasons.
It is interesting to note that the toxin produced by the GM maize in this experiment was Bt toxin, so named because it is found in a common soil bacterium, Bacillus thuringiensis. Bt toxin is used by organic farmers as essentially their only pesticide, and they fear that its use in GM crops might cause the insects it protects against to develop immunity. This, rather than concerns over Bt toxicity, lies at the heart of opposition from organic farmers. (9)
Reductionist risk assessment -- attempting to regulate solely on the basis of toxicity -- ignores these crucial exposure factors and relies solely upon the science of toxicity, which can be persuasive, especially to those who wish to invoke the risk-averse precautionary principle. It not only advantages economic interests threatened by the advantages of Bt maize, however, but also carries an environmental opportunity cost (what has to be given up as a consequence), since non-modified maize is sprayed for insect pests 8–10 times, a practice which is likely to cause substantially more harm to monarch butterflies and other insects.
Social risk assessment requires a careful analysis of the best available science, an understanding of the social and psychological factors which will inevitably intrude into the process, and careful policy analysis. (10) Such policy analysis requires prioritisation of candidates for risk management, which is made all the more difficult because of the "shouting" of the "danger establishment", and a careful weighing of the costs and benefits involved. No activity can ever be risk-free. (American author Robert Benchley once remarked that the only way of avoiding accidents was to remain in bed, but even then there was a chance you might fall out.) There is always a need to consider the costs of risk management -- including opportunity costs -- and to be careful of the social context within which the decision is made. A cholera epidemic in Peru once killed 3,000 people because of a decision to follow a US EPA risk assessment and not chlorinate water supplies. (11) Chlorinated water carries an elevated risk of bladder cancer of 0.8 per 100,000, (12) but we need to remember that the costs of avoiding this risk can be much higher.
RISK AND PRECAUTION
The cholera example is particularly apt, because the actions of a physician amid the squalor of the industrial revolution are often taken as reinforcement of the need to apply the "precautionary principle" in cases of environmental or health risk. In 1849, before the discovery of the cause of cholera, a London doctor, Dr John Snow, suspected that the source of one outbreak might be the water from a particular well, and removed the pump handle.
Precaution is, of course, much better than cure, but such an anecdotal understanding of history glorifies post hoc those who happened to be right and ignores the multitude of cases where doctors acting on similar imperfect knowledge got it sadly wrong. How we should exercise precaution is by no means self-evident, and the reasonable-sounding, commonsense precautionary principle is frequently misquoted and distorted to the point of nonsense.
The accepted version of the precautionary principle (in the Rio Declaration in 1992) reads: "Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation". (13) This is commonsense, but alone it cannot be operationalised: we need to add meanings to "serious", "irreversible" and "damage" and decide what level of uncertainty we are prepared to accept as the basis for action.
Advocates often use the example of cigarette smoking. It involves both business interests and uncertainty, and they like to point to the exploitation of that uncertainty by industry to forestall regulatory action. We now know the precise mechanisms by which substances initiate cancer and aid progression by damaging two genes, but in fact we commenced regulatory action against tobacco long before we had identified precise mechanisms of causation. We did so on the basis of good peer-reviewed science which indicated a problem over 30 years ago, and while the tobacco lobby has been particularly active and we have not banned tobacco, that reflects a number of factors, including the loss of regulatory control (and taxation revenue to pay the costs of damage) prohibition regimes carry with them (witness heroin).
But it is not prudent to take regulatory action on the basis of no evidence, or non-peer-reviewed science, or even a handful of scientific papers. Sometimes we choose to accept risks: a risk assessment of quartz almost resulted in a ban on children's sandpits in Sweden until reality prevailed. (14) Motor vehicles kill thousands, directly or indirectly, but we accept that their benefits outweigh these risks. But some seek to invoke the precautionary principle as a justification for not just reversing the burden of proof, but to demand a logically-impossible proof of safety, or the absence of harm. Demanding that a negative be proved is the logical equivalent of asking people to prove that they are not witches.
In addition, however, environment groups and official documents have stretched the meaning of the precautionary principle to the point where it legitimises the risk management strategy of Chicken Little and this has even found its way into international policies. For example, Recommendation 89/1 of 22 June 1989 of the Paris Convention for the Prevention of Marine Pollution from Land-based Sources (PARCOM) stretched it to include action "even where there is no scientific evidence to prove a causal link between emissions and effects". (15) If this is accepted, all one needs is some indication of serious and irreversible effects and one can demand logically-impossible proof of an absence of harm or else regulatory action will be taken.
Everything is capable of causing harm under some circumstances: as Paracelsus put it 500 years ago, everything is poisonous -- the dose makes the poison. So we must insist that the precautionary principle is not misused and that risk assessment considers factors such as doses, exposure pathways, individual and species susceptibilities, costs and benefits and the consequences of regulatory actions. Unless we do, we are to forgo the benefits that a product might bring, and produce either policy paralysis (as regulators freeze like rabbits in the glare of a multitude of precautionary spotlights), or a wasteful misplaced set of priorities (causing regulators to chase any number of hares which have been released).
RISK AND GMOs
How does this apply to GMOs? In order to answer that question, it is necessary first to state that the discussion which follows does not seek to make a risk assessment of GMOs, nor engage in a detailed discussion of the science of genetic modification and the hazards it might pose. The analysis accepts that genetic engineering is a hazardous activity which has been subjected to regulatory scrutiny from basic research through to its applications since its inception in 1970. It accepts also that the products of this technology provide benefits. It accepts that the risk management process will be difficult and complex, but unless it is performed we run the risk of either forgoing benefits or experiencing hazards.
But it also holds that risk assessment must be sensitive to particular products and practices and specific exposures. A bacterium modified to produce BST poses different risks than genetically modified cotton, and cottonseed oil so produced poses different risks from the consumption of a GM tomato, where live DNA might be ingested. The dangers posed by the possible escape of genes to wild species depend crucially upon the GM species and the environment into which it might be placed. For example, for the UK, there are no compatible wild relatives for maize or potatoes, so no gene transfer can occur. Rice and soya are inbreeding species, so transfer is possible, but unlikely. With oil rapeseed, on the other hand, this is an outbreeding species with many wild relatives, so greater caution is necessary. The same holds for the dangers from consumption. Sugar from GM sugar beet contains no genetic material whatsoever; flour from GM soya may contain the new gene or its product, but many of the purification processes used in food production will destroy any DNA present in the raw material. (16)
It is entirely possible that we might as a society decide that the risks of one GM product are worthwhile while rejecting others. We might reject a GM blue rose as being a trivial use of the technology which poses an unacceptable risk, while accepting the gains of GM foods which taste better, keep better and thus result in less wastage. Lumping all genetic engineering together, and certainly condemning all GM foods as "Frankenstein food", is neither accurate nor helpful.
Making such decisions requires the participation of a wide range of people other than just the relevant scientists, industry and environment groups. Risk management is a process which requires the application of relevant science, as well as statistics, ethics, economics, sociology and even political science, and certainly must have regard to the views of the public. Attempts by scientists to prevent what they might see as the intrusion of "non-experts" into the process are not only unhelpful, but are likely to heighten public suspicion and apprehension. Transparency and trust are vital.
There is a legitimate role for both industry and environment groups in this process, but neither should be allowed to dominate the process. Unfortunately, the alarms seem to have run ahead of a reasoned consideration of the issues in Australia. Despite the fact that there are few GM plants yet licensed for use here, we have considerable apprehension as the result of tabloid reporting of the perils of "Frankenstein food", with local government authorities even banning GM food in kindergartens and day-care centres.
The fear of "Frankenstein food" has been markedly more in evidence in Europe than in the US, and it has had more impact on government policies and on the policies of corporations. Some supermarkets have refused to stock GM foods as the result of the effectiveness of boycotts by Greenpeace's "Genetic Hazard Patrols". The responses of European governments have varied. The UK, France and Spain appeared initially to be more permissive than the Northern European nations where support for Greenpeace and green political parties is strongest, but the question arises as to why the alarms have had greater impact in the European Union than in the US.
A similar question arises as to why concern has been almost non-existent over the use of genetic engineering to produce pharmaceuticals.
The answer to the first question lies partly in the accepted fact that cultural dispositions to risk vary, (17) even within Europe, with much higher support for such causes evident in Northern Europe than in Southern Europe. But consumers in the US, especially in the Western States, are well known for their propensity to be concerned about such risks. The best explanations for these regional differences lie in a happy coincidence between such values and economic interests which has led to institutional innovations which privilege risk-averse responses.
The precautionary principle had its origins in Germany as the vorsorge prinzip (roughly "preventive action principle") and was used to justify the "Green Keynesianism" developed by Helmut Kohl, also known as "ecological modernisation". (18) The export of the precautionary principle has not only bolstered the approach domestically, but has helped create markets for the export of technology and services developed domestically. This is known as a "first mover" strategy and runs counter to the widespread belief that environmental regulation hinders the competitiveness of nations -- though it does depend on the successful export of policies and standards which will create a market for the technologies and services in which the nation has new-found advantage. (19)
As we saw before, misapplied, the precautionary principle has considerable potential to undermine the risk management process from the outset by giving credence to poor science, and this has happened with GM food. In a notable case, research on rats at the Rowlett Research Institute in Aberdeen was reported on television in 1998 to suggest that potatoes modified by the addition of a snowdrop gene to produce a natural insecticidal chemical, lectin, interfered with the development of both the rats' internal organs and their immune systems. The research was not on transgenic potatoes about to be marketed, but an early part of research aimed at finding whether a form of lectin which was (on the basis of previous testing) likely to be least toxic to humans could protect potatoes from nematodes.
The researcher, Dr Arpad Pusztai, has since been dismissed from his job for a serious breach of scientific protocol -- going public with his claims before his research had been peer-reviewed and published in a recognised scientific journal. No paper has yet been submitted for publication, and a panel of six toxicologists appointed by the Royal Society has dismissed the research as irrelevant and inconclusive, being flawed in many aspects of design, execution and analysis. (20)
By the time this rebuttal appeared, the claims had already been a key catalyst in the GMO debate in Britain, and a group of 20 scientists had held a press conference to declare their support for Dr Pusztai. Despite the conclusion by the Royal Society panel that any observed differences between GM-fed rats were uninterpretable because of the technical limitations of the experiment and the incorrect use of statistical tests, Friends of the Earth was unswerving in its views of the dangers of GM foods. FOE spokesman Tony Juniper resorted to the "witchcraft" position: "There's no concrete proof that they are safe".
According to Debora MacKenzie in the New Scientist (not known for its conservatism on such matters), the "technical limitations" of the experiment included the fact that Pusztai could not get the rats to eat enough potato (they were malnourished no matter what kind they were eating and had to be given protein supplements to meet Home Office guidelines for animal experiments). Another was the presence of known toxins in potatoes. The only obvious conclusion supported by his research, MacKenzie stated, was that rats hate potatoes. (21) In fact, it was worse than that, as the methodology did not involve "blind" testing under which researchers are unaware of which rats were in the control group, and which were being fed GM potato. This introduced the possibility for the introduction of researcher bias, something of a concern when Dr Pusztai was prepared to go public before publication.
There are a number of technical issues which make the testing of GM foods difficult, but as the reference to toxins in potatoes suggests, this holds for unmodified food also, since dozens of people die each year from the cyanide in peach seeds, and under-cooked kidney beans are poisonous (they contain the very lectins for which Pusztai's research was trying to find an alternative). Many foods also naturally contain chemicals which have exhibited carcinogenic properties in laboratory tests, (22) but in such small amounts that test procedures are likely to require such large quantities to be fed to rats that the acute toxicity of other substances is likely to kill them first.
An attempt to test GM tomatoes in the Netherlands involved feeding rats the freeze-dried equivalent of 13 tomatoes a day each, but this dose was still not enough. Monsanto's GM maize does not contain enough of the Bt toxin produced by the novel gene for it to be isolated for testing, so they have to produce it from bacteria and then test it, but this raises questions about whether the two toxins are identical. Some transgenic foodstuffs (Flavr Savr tomatoes, Round-up Ready soybeans, and virus-resistant squash, for example) have undergone extensive testing without any suggestion of serious health effects, (23) which should have suggested caution about the potato research.
This suggests there is a need for caution with how we evaluate the hazards of GMOs, but it also stresses the need for the best possible science underpinning our risk assessment processes. Much of the difference between the approaches of the EU and the US reflects the different philosophies of risk which operate in each jurisdiction. The institutionalisation of the precautionary principle in Europe encourages both calls for action and government action itself on the basis of such "scientific" evidence as the potato research of Dr Pusztai, while the US approach to risk (since the Reagan Administration required the conduct of Quantitative Risk Assessment) has been to examine the economic costs and benefits of any risk management action.
Ironically, the relative absence of the consideration of economic factors in the EU approach facilitates the use of fears of GMOs by economic interests. The fight against US beef produced using recombinant BST has been led by British beef producers, themselves harmed by BSE, and the whole issue has allowed Europe to revisit the 1985 issues. The US has advantages in the use of biotechnology, and its economic efficiency poses a considerable threat to the enormously costly and inefficient Common Agricultural Policy, already under pressure after the Uruguay Round liberalisations in agricultural trade. The GMOs debate has provided less efficient European producers of beef, soybeans and so on with an opportunity to try to nobble their more efficient US competitors.
This partly explains why there has not been a similar outcry over genetic engineering in the pharmaceuticals sector: Europe has an efficient, competitive pharmaceuticals sector which would oppose and contest campaigns on the issues, rather than support them (as with agriculture). But even though the consumption-related risks from pharmaceuticals -- often directly injected into the body or packaged in such a way as to facilitate absorption even after attack by digestive juices -- would appear to be equivalent to those associated with foods, there has not really been a campaign mounted against them. There are at least two other factors at work here: one relating to pharmaceuticals and the other to agriculture.
The first is that the benefits side of the equation is much clearer with pharmaceuticals and would be much more difficult to counteract. A soybean which can be produced more cheaply does not quite offer the same kind or size of benefits as a drug produced by a GM bacterium. Focusing political campaigns on food promises better political returns than attacking possible cancer cures, especially when it coincides with agricultural interests in Europe.
The second is that the anti-GM food campaign resonates strongly with an earlier campaign in the early 1980s over the introduction of Plant Variety Rights (PVR) -- or intellectual property rights for plants. Many of the concerns then, such as the fear that agricultural genetic material would be controlled by large transnational corporations, not only have been repeated with the GMO campaign, but the same fear of transnational dominance is (as we have seen) a key factor in amplifying risk perceptions of GMOs.
These fears have been heightened by the insertion of so-called "terminator genes" into seeds, which render the seeds of transgenic crops infertile, requiring growers to buy again from the multinationals rather than engaging in the traditional practice of saving seed for next year's crop. This would appear to be something of a non-problem: Third World farmers will be perfectly able to continue traditional farming practices with traditional seed; transgenic crops will only be grown where the benefits outweigh the costs of doing so. The situation is no different from that obtaining with the seeds of infertile hybrids, except that "terminator genes" could be seen to serve a useful risk management function by preventing the escape of GM stock into the wild.
CONCLUSION
The assessment of the risks of GMOs can be seen to reflect numerous social and institutional factors, and these help explain the differences between the approaches in the US and the EU, and between transgenic food and transgenic medicine. These factors are giving rise to particular problems for the trade regime as they offer plenty of scope for non-tariff barriers to be erected in the name of the protection of health or the environment, but they also throw some light on the elements we need to bring together in order to assess properly the risks associated with GMOs.
First, there is a fundamental need for good science and insistence on sound, peer-reviewed science and rejection of evidence gathered to support theoretical predispositions -- either that GMOs are dangerous or that they are harmless.
Second, there is a need to consider the benefits as well as the dangers, and the costs (including opportunity costs) of any decision we take. We should expect that any GMO might not be all that the owners of the technology might make it out to be, but neither are they without the promise of considerable benefits and cannot, therefore, be rejected lightly.
There is also a need to undertake specific risk assessments for different kinds of GMOs, taking care to distinguish production-related risks (of, say, GM canola cross-pollinating or out-breeding with other species) from consumption-related risks (such as, if Dr Pusztai turned out to be right, GM potatoes affecting our immune systems).
There is also a need to accept that the social evaluation of risks is likely to be more accepting of GMOs in medicine than in food, and that such evaluations must be a central part of any risk management process. There are identifiable reasons why what society will accept in saving lives, it might not tolerate in producing food. That might hinder the adoption of GM technology in agriculture, but attempting to impose outcomes on a reluctant public is likely only to heighten fears. Openness and transparency -- together with good science and a consideration of costs -- are the keys, but this does not mean that the proponents of GM technology should abandon the field to their critics. Society requires a full and open debate which will expose the exaggerated claims which might come from any side and allow it to make better decisions about which risks to accept and which to reject.
Issues such as genetic engineering are tailor-made for the development of what Frank Furedi has called a "culture of fear". (24) Such a culture thrives on secrecy and attempts to manipulate public opinion to secure consent, which inevitably arouse suspicion and hostility. If genetic engineering is to come to be regarded as involving socially-acceptable risks, the process by which the risks are assessed and managed will have to be one in which the public trusts.
Our assessment of the risks of GM foods must therefore be careful to take many factors into account. Genes -- that is, DNA -- are a normal constituent of our diet. It is 200 years this year since the first report of hybrid cereals was made, and we have been consuming the fruits of the deliberate human transfer of genetic material between species since 1876 (Triticale wheat x Rye cross). GM techniques expand these possibilities enormously and rightly should be subjected to careful regulation. But we would be wrong in supposing that all the risks we face are caused by human agency, or that we are completely incapable of regulating them.
Ironically, both these lessons can be drawn from the "mad cow disease" experience. The former is suggested by the fact that the best hypothesis about the origins of BSE and nvCJD seems to be a chance occurrence of a rare spongiform encephalopathy (probably from scrapie in sheep) which found its way into cattle food and thence into the human diet. (25) The route might just as readily gone straight from sheep to humans, but for a roll of the genetic dice. The outbreak might have resulted from feeding rendered sheep carcasses to cattle, but the genetic chance occurrence appears to have been a completely natural occurrence.
The BSE/nvCJD outbreak, despite the alarms, also demonstrates that we are capable of regulating risks. BSE in cattle was first positively diagnosed in cattle in 1986, and regulatory action was taken in 1988 and 1989 to remove infectious material from the animal and human food chains. The risks of human exposure were highest at this time, when public concern was almost non-existent, and with a possible ten-year incubation period; by 1997 there were only 19 established cases of nvCJD in Britain and one in France. About a million cattle were slaughtered and Britain's beef trade was harmed, but (despite the high economic stakes) scientists and regulators minimised the impact of the tragedy. It is most certainly a tragedy, but it has not quite been an apocalypse, yet the role of good science and risk management in limiting the scope of the tragedy has been submerged in a climate of dread, and the risk management success overlooked.
The BSE/nvCJD tragedy, as has been noted, had nothing to do with the GMO debate, except in its impact on public perceptions -- indeed, GM growth hormones have removed the major source of risk of transmission of spontaneous CJD (barring outbreaks of ritual cannibalism). But the suspected origins of the BSE outbreak also contain an important lesson about how we should evaluate the risks of GMOs.
It is thought that until the early 1980s, the process by which carcasses were rendered for stock food destroyed the infectious prion from the scrapie as they were subjected to high temperatures and organic solvents to remove the tallow. The price of energy rose, the price of tallow fell, and concerns emerged over the exposure of workers to organic solvents, so a new process was adopted to avoid solvents and high temperatures. The scrapie prion survived the new process and subsequently it is believed to have infected cattle. (26)
This serves to remind us that our actions have consequences that are difficult to imagine. This holds not just for the introduction of new technologies, but both changes to old ones and decisions to withhold new technologies. GMOs present risks, but they also present considerable opportunities. The challenge is to manage the risks in order to maximise the benefits. How we do this requires the best possible science, the right amount of precaution, and open and democratic processes, an admixture which will be difficult (but not impossible) to achieve.
ENDNOTES
1. See John H. Jackson, "Dolphins and Hormones: GATT and the Legal Environment for International Trade after the Uruguay Round", UALR Law Journal, 14, 1992, pages 435–36.
2. See Paul Slovic, "Perception of Risk: Reflections on the Psychometric Paradigm" in Sheldon Krimsky and Dominic Golding (eds), Social Theories of Risk, Westport, CT, Praeger, 1992; or Joseph V. Rodricks, Calculated Risks: Understanding the Toxicity and Human Health Risks of Chemicals in Our Environment, Cambridge, Cambridge University Press, 1992. For an excellent introduction to the topic of risk, see John Adams, Risk, London, UCL Press, 1995.
3. Mary Douglas, Risk and Blame, London, Routledge, 1992; page 15.
4. For a discussion of the importance of patents in regulation of chemical and pharmaceutical risk, see Aynsley Kellow, International Toxic Risk Management: Ideals, Interests and Implementation, Cambridge, Cambridge University Press, 1999 (in press).
5. For an example of this genre, see Sharon Beder, Global Spin: The Corporate Assault on Environmentalism, Melbourne, Scribe, 1997.
6. See James T. Rosenbaum, "Lessons from Litigation over Silicone Breast Implants: A Call for Activism by Scientists", Science, 276, 6 June 1997, pages 1524–25.
7. See Thomas M. Dietz and Robert W. Rycroft, The Risk Professionals, New York, Russell Sage Foundation, 1987.
8. John E. Losey, Linda S. Rayor, Maureen E. Carter, "Transgenic pollen harms monarch butterfly", Nature, 399, 1999, page 214.
9. See VitalSource, "GM: What is known and/or in dispute?" at http://www.vitalsource.org/gm/science.html.
10. See John D. Graham and Jennifer Kassalow Hartwell, "The Risk Management Approach" in John D. Graham and Jennifer Kassalow Hartwell (eds), The Greening of Industry: A Risk Management Approach, Cambridge, Mass., Harvard University Press, 1997.
11. Christopher Anderson, "Cholera epidemic traced to risk miscalculation", Nature, 354, 1991, page 255.
12. Rodricks, op. cit., page 218.
13. See Lawrence E. Susskind, Global Diplomacy: Negotiating More Effective Global Agreements, New York, Oxford University Press, 1994; page 79.
14. See Robert Nillson, "Integrating Sweden into the European Union" in Roland Bal and Willem Halffman (eds), The Politics of Chemical Risk: Scenarios for a Regulatory Future, Dordrecht, Kluwer, 1998.
15. Nigel Haig, "The Introduction of the Precautionary Principle into the UK" in Timothy O'Riordan and James Cameron (eds), Interpreting the Precautionary Principle, London, Earthscan, 1994; pages 243–246. (Emphasis added.)
16. For a discussion of these issues, see The Royal Society, Genetically Modified Plants for Food Use, London, The Royal Society, September 1998.
17. Aaron Wildavsky and Mary Douglas, Risk and Culture, Berkeley, University of California Press, 1981.
18. Sonja Boehmer-Christiansen, "The Precautionary Principle in Germany -- Enabling Government" in Timothy O'Riordan and James Cameron (eds), Interpreting the Precautionary Principle, London, Earthscan, 1994.
19. David Vogel, Trading Up: Consumer and Environmental Regulation in a Global Economy, Cambridge, Mass., Harvard University Press, 1995.
20. See the report "GM food study was 'flawed' " by BBC News on 18 May 1999 at http://news.bbc.co.uk/hi/english/special_report/1999/02/food_under_the_microscope/newsid_289000/289002.stm
21. Debora MacKenzie, "Unpalatable Truths", New Scientist, 10 June 1999 at http://gmworld.newscientist.com/
22. See Bruce N. Ames, Renae Magaw, Lois Swirsky Gold, "Ranking Possible Carcinogenic Hazards", Science, 236, 17 April 1987, pages 271–80.
23. See OECD, Food Safety Evaluation, Paris, OECD, 1996.
24. Frank Furedi, Culture of Fear: Risk-taking and the Morality of Low Expectation, London, Cassell, 1997.
25. The Royal Society, Second Update on BSE, Statement by the Royal Society, London, 21 July 1997.
26. The Royal Society, BSE -- A Statement by the Royal Society, London, 2 April 1996. As John Adams has noted, however, the prion theory of causation is by no means universally accepted. See John Adams, "Cars, cholera and cows: virtual risk and the management of uncertainty" Science Progress, 80, 1997, pages 253–272.
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