A Response to the Department of the Environment's Consultation Paper - Genetically Modified Organisms and the Environment

on behalf of VOICE (Voice Of Irish Concern for the Environment)

Sean McDonagh (Chair of VOICE)

In January 1998 the Minister for the Environment promised that his department would shortly publish a consultation paper on genetic engineering. The document entitled Genetically Modified Organisms and the Environment finally appeared in August 1998. It purports to be an objective, even-handed document, explaining what genetic engineering is and outlining the national and European Union regulations governing the release of genetically engineered organisms or the sale of genetically engineered food. However, as many in the NGO (non-governmental organisation) community feared when the "consultation" process was announced the document is heavily weighted in favour of the biotech industry's point of view. They have defined the debate in their terms and therefore it is very difficult for those who come from a very different perspective to engage in a genuine debate at this point.

From the very first page the use of the term 'traditional' and 'modern' biotechnology gives the impression that there is an inevitable evolution and continuity between traditional breeding practices that were restrained by species boundaries and the radical techniques involved in recombinant DNA technologies. Those who oppose the deliberate release of genetically engineered organisms at this point in time dispute this claim. Such fundamental differences in approach should have been acknowledged in an unbiased report. Furthermore the critics wish to see a genuine public debate about all aspects of this new, extraordinarily powerful technology before communities are swamped by food products containing transgenetic plants or animals. Those opposed to the present commercially driven pressures to get genetically engineered products to the market wish to scrutinise the technology thoroughly. This is quite understandable since the technology has the power to reshape the world of nature and human nature itself in a most radical way. Governments ought to facilitate such a scrutiny; they are elected to protect the common good and not just to secure comparative commercial advantage for biotech companies.

The Consultation Paper is not the kind of root-and-branch assessment one might expect given what is at stake. It is little more than a revision, updating and reworking of regulatory guidelines, many of which are totally inadequate. The paper naively asserts that biotechnology has the potential to "support economic growth and employment creation" without analysing who will benefit most and lose most if the technology assumes the dominance which the biotech industry is seeking. VOICE argues that the main beneficiaries will be a handful of giant agribusiness and biotech companies who, in the process, will secure a monopoly over many of the staple crops of the world. Such concentration of economic power in the hand of few massive companies for something as important as our food raises serious questions about equity and sustainability. It certainly will not benefit the vast majority of humankind, especially those who live in the Third World. Even farmers on small and medium sized farms in the First World stand to lose. The document does not mention the fact that in 1997 the Mississippi Seed Arbitration Council ruled that Monsanto's genetically engineered Roundup Ready cotton failed to perform as advised and as a result recommended that the farmers receive $2 million compensation for their losses.

The fears and anxieties which have arisen as a result of the biotechnology revolution were accurately captured in a joint statement by Minister Dempsey and his colleague, Joe Walsh T.D., present Minister for Agriculture while in opposition on April 26th, 1997. They argued that "it is premature to release genetically modified organisms into the environment or to market food which contain any genetically modified ingredient..." The reason for such a stand was very simple "Fianna Fail will not support what amounts to the largest nutritional experiment in human history with the consumer as guinea pig".

Though not explicitly stated this is fundamentally an ethical argument. It is significant that the word ethical only appears twice in the 76 page Consultation document on pages 7 and 47. In neither case is there any effort to develop an ethical framework or enunciate any ethical principles which might be helpful in assessing this powerfully intrusive technology from an ethical perspective. Such an oversight, in a country where over 90 percent of the people subscribe to the Judeo-Christian tradition which has a very strong ethical core, is difficult to explain. This paper will attempt to address some of the ethical issues involved in genetic engineering.

In debating the ethics of genetic engineering it is essential to develop an appropriate ethical framework for this new and powerful technology which can literally transform not just human life but life itself. This will demand a major shift away from the almost exclusively human or homocentric focus which has been so pervasive in the Western ethics and wider cultural traditions for almost two thousand years.

Aristotle, whose impact on Western thought is enormous, held that since "nature makes nothing without some end in view, nothing to no purpose, it must be that nature has made (animals and plants) for the sake of man" (^·). This idea that animals and plants are created for humankind - either by God or the processes of nature - has dominated western attitudes to animals, plants and the rest of creation for many centuries.

From this viewpoint, since animals and plants exist for human beings, our behaviour towards them is not governed by moral considerations. It is only in the past decade that the cruelty involved in factory farming or blood sports has been discussed from an ethical perspective. Even then the proscription on cruelty towards animals arises, not so much from inherent rights that animals might have, but from the understanding that any form of cruelty is unbecoming and, therefore, unethical for rational beings.

It is also true that certain elements within the Judeo-Christian tradition have strongly reinforced the Aristotelian legacy. This is particularly the case when one considers the traditional interpretation given to Gen 1: 26-28. "Increase and multiply and dominate the Earth". This is often interpreted, mistakenly, according to contemporary scripture scholars, to give humans a licence to dominate the Earth and do whatever they wish with animals and plants.

The historian, Keith Thomas, points out that at the beginning of the 16th century, just as modern science was finding its feet, neither Western literature nor the theological tradition ascribed any intrinsic meaning to the natural world or accorded it any rights apart from its role in serving humankind (). From the theological perspective it was argued that humans had intrinsic value because they were made in the 'image and likeness of God' ( Gen 1: 26). Their role was to be "masters of the fish of the sea, the birds of heaven and all living animals on the earth" (Gen 1: 28). No other creature bore this Imago Dei stamp. Animals and plants were viewed as lacking rational faculties, self-consciousness and often even sentience and hence had no intrinsic worth in themselves. They only had instrumental value in so far as they served the needs of humankind for the necessities of life and even entertainment.

It is true that within the Judeo-Christian tradition there is a strand that sees humans as stewards of creation ( Gen 2: 15). Unfortunately, as Clive Ponting points out in his Green History of the World, "although the idea that humans have a responsibility to preserve the natural world of which they are merely guardians can be traced through a succession of thinkers it has remained a minority traditions" (). This gulf between humans and the rest of creation was widened further by the insights of many of the people who have shaped our modern scientific, economic and social world.

In this very formative period in human-earth relations when the foundations of the modern scientific and industrial society was being shaped in the works of people like Francis Bacon (1561-1626), Rene Descartes ( 1596-1650) and Isaac Newton ( 1642-1727) all rights were ascribed to humans. In the words of Descartes the goal of human knowledge and technology was so that humans might become "the masters and possessors of nature" (). Furthermore philosophers like Hobbes, Locke and Jeremy Bentham dismissed the medieval view of the cosmos as organic and substituted instead a mechanistic view of nature and its law. For these men the best way to understand the Cosmos was to see it as a giant clock. Newton believed that the laws of motion, which he discovered proved that the same "universal laws that governed the smallest portable watch also governed the movements of the earth, the sun and the planets" ().

For Descartes animals were, res extensa, little more than mechanised entities without any interior quality or soul. Only res cogitans or humans, as conscious beings, were endowed with souls and therefore could be considered to have moral value. Animals had no such intrinsic value and could be treated in any way that might serve human ends no matter how cruel and degrading that might be. Furthermore these men of the Enlightenment viewed science, and its handmaiden technology, as a tool designed to give humans the power to dominate and manipulate the earth in whatever way they saw fit in order to promote human well-being and betterment.

Genetic engineering fits comfortably into this mechanistic worldview. Scientists, working in the field of genetics and biotechnology discovered the insights and technology which people like Francis Bacon dreamed about in New Atlantis (1627). This new technology gives humans the capability to manipulate the building blocks of life in order to reshape the natural world in a most extraordinary way. Most of the questions surrounding genetic engineering deal with whether it will be damaging to human health or the environment. In general the wider ethical questions are often simply ignored.

Besides the potential harmful risks that can be envisioned today, genetic engineering may also pose risks that we do not have sufficient knowledge at the moment to identify. It is after all a very young science with many new discoveries being made in a very short space of time. It is estimated that the quantity of information in the science of genetics is doubling every two years.

Professor David Suzuki who has worked in genetics since 1961 smiles when he reflects on how the certainties which he held in the 1960s have all vanished. He writes "today when I tell students the hottest ideas we had in 1961 about chromosome structure and genetic regulations, they gasp and laugh in disbelief. In 1997, most of the best ideas of 1961 can be seen for what they are - wrong, irrelevant or unimportant...... So what is our hurry in biotechnology to patent ideas and rush products to market when the chances are overwhelmingly that their theoretical rationale will be wrong?" (). Closer to home another well-known environmentalist, David Bellamy acknowledges that "genetically modified products worry him" ().

This is not an argument for stopping research into this technology, but it does put a substantial burden on those who wish to engage in deliberate releases to demonstrate the safety of their products and the benefits which they will bring. Furthermore, if things do go wrong, it will be impossible to recall the organisms that are multiplying in the environment. It is not like a batch of malfunctioning cars that can be repaired and returned to the owner. Genetic engineering deals with organisms which produce, mutate and interact with other organisms in the environment.

VOICE’s position is based on a recognition of the fact that genetic engineering has the potential to reshapes other creatures in a radical ways and, therefore, should be approached with great care. Furthermore, since the risks associated with it are not fully understood, we should proceed with extreme caution. Genetically engineered organisms should not be released into the environment until society has a much greater knowledge and appreciation of the health, environmental, social and economic risks involved and until we have addressed the ethical issues .

But before going on to deal with some of the above questions it is well to remember that, while modern technology has increased the level of affluence for 20 or 30 percent of the human family, it often comes with a sting in its tail.

The sad irony is that modern technology, especially in its chemical and nuclear phase, while it has delivered benefits to a segment of humanity in the form of better nutrition and longer lifespan, it has wreaked havoc on the planet and, even today, threatens the future of many life forms, including humankind itself.

The internal combustion engine has brought increased mobility to many people in the 20th century. Yet the proliferation of cars around the world and the greenhouse gases that they emit threaten to destabilise the planet's climate system. This could have potentially catastrophic consequences for humans and other creatures. Unless it is radically restructured much of this technology is unsustainable.

In recent times many discoveries have been found to have very adverse unintended effects that those who developed them were unaware of. A few examples will suffice: It took over two decades for scientists like Rachel Carson to discover the impact of DDT on the reproductive behaviour of birds. The widespread use of DDT as a pesticide in the US began in the 1930s. In the 1940s it was used globally, especially in malaria eradication schemes. DDT is highly persistent in the environment. By the 1950s scientists began to link DDT with the thinning of egg-shells in many species of birds and their consequent failure to reproduce. Birds of prey like the eagle, ospery and peregrine falcon were particularly affected. It was also discovered that DDT caused cancer. In 1971 after a protracted battle against chemical companies that produced DDT it was banned in the USA. Since then it has been banned in many Northern countries, though it is still used widely in the Third World.

For almost fifty years chlorofluorocarbon (CFCs) was considered to be the perfect chemical for refrigeration. Then in the 1970s it was discovered that CFCs destroy the ozone layer of the atmosphere which protects humans and other creatures and plants from the damaging ultraviolet rays of the sun. Many of the chemical companies which manufactured CFCs denied the connection until the mid-1980s. Eugene Linden writing in Time Magazine (May 10, 1993) claims that "in the United States those who had the power to take action engaged in self-delusion: The Reagan Administration at first dismissed the ozone threat as a non-issue, while Du Pont and other manufacturers underestimated future sales of CFCs making the hazard seem minimal". Both industry and the regulatory agency were very much to blame ().

While all the above technologies have changed the human condition and the environment in various ways none are as intrusive as genetic engineering for the simple reason that it allows humans to scramble and reprogramme the genetic code of all life forms on earth, including humans. This is an awesome possibility and needs to be approached slowly and with great care. Commercial considerations must not be allowed to promote this technology full steam ahead, without a long and through public debate about the potential benefits to humankind and the earth and possible nightmares that might be created.

Before examining the ethical issues involved in genetic engineering it might help to outline briefly, and in a very simplified way, what is involved. Genetic engineering is a by-product of the relatively young science of genetics. The science emerged out of the pioneering work of the Austrian, Augustinian priest, Gregory Mendel. In a paper published in 1865 he developed his theory of organic inheritance from his work on the hybridisation of green peas. Unfortunately, his work remained unrecognised until the early 1900s. By the 1920s genetics was being used to help plant breeders improve their crops.

Genetics took another leap forward in the 1950s when two young scientists, James Watson and Francis Crick, discovered the physical make up of DNA (deoxyribonucleic acid), the fundamental molecule of life. They discovered that the DNA structure was a double helix. The two strands were twisted around each other like a spiral staircase with bars extending across the connecting strands. These units, composed of four different chemical nucleotides, arrange themselves in an endless variety of patterns that form the genes. It is the precise ordering of the chemical base in the DNA molecule which makes each life form unique. Simple life forms like bacteria are composed of a few hundred genes. A more complex organism, like the human body, is composed of more than 100,000 genes. In the light of Watson's and Crick's discovery, biologists began to realise that by changing the ordering pattern of the genetic material they could change or modify life forms.

But this discovery, though crucial, was not sufficient to enable scientists to cut up, delete, or recombine genes. They needed tools to cut the genes and, once cut, they required a suitable mode of conveyance or vectors to insert the genetic material into another organism. The cutting tools were discovered in a group of enzymes which are called "restriction enzymes". They have the ability, as part of their defence mechanism, to splice up DNA. In 1973 Drs. Stanley Cohen and Annie Chang inserted genes from a South African clawed toad into a bacterium E.coli. When the E.coli reproduced themselves they also reproduced the toad gene that had been inserted into the bacteria. Today plants and animals with genes taken from completely unrelated species are being engineered in the laboratories of biotechnology companies and released into the environment. Proponents of genetic engineering claim that it is very much in continuity with older breeding practices. It is nothing of the sort. Genetic engineering is a new technology. It crosses species barriers in a way that permanently alters the genetic code of living organisms.

A company called Calgene developed a genetically engineered tomato called Flavr Savr in the US and Europe. This tomato was approved by the US Food and Drug Administration (FDA) in May 1997. The goal of the experiment was to extend the shelf life of the tomato which is marketed under the brand name of "McGregor". Calgene invested a whopping $95 million in the process which involved isolating a gene that encodes for an enzyme involved in the ripening process. Having discovered the enzyme the technologist blocked its expression.

As a result the tomatoes will take a few days to ripen on the vine and still maintain a firmness during shipping. As a consequence the unfortunate consumer will be duped into believing that the tomato is much fresher than it is. Extending the shelf-life means that the crop can be grown much further away from the retail outlet. For example, it is now possible to grow the tomatoes in places like Central America where the labour and environmental laws are much less strict than those in the United States. Calgene has already been in touch with Mexican growers with a view to producing Flavr Savr on their lands

Scientists have also attempted to create leaner and more cost effective pork through genetically engineered pigs even though the animals experienced extensive arthritis. They can re-engineer the genetic blueprint of an animal or plant in order to create a "super animal" or a higher yielding plant. On the medical side genetic engineering has created the first patented mammal, called the OncoMouse. This creature was genetically engineered with a human gene to express cancer in the mammary gland. It is now possible to create new transgenetic viruses, bacteria, plants or animals which could be used to secrete in the milk or blood large quantities of inexpensive drugs or chemicals suitable for human use.

As already indicated already VOICE feels that our anthropocentric Western scientific values and ethical norms are not capable of addressing these vital contemporary moral issues in any comprehensive or effective way. Even the "minimum ethical consensus" proposed by the theologian Hans Kung appears to be mainly human-centred. It includes the fundamental right to life (human), just treatment from the State and physical and mental integrity. The consensus is geared to creating "the smallest possible basis for human living and acting together ().

How humans might relate to other species is not on this ethical landscape. Yet that is a matter of life and death for many species, possibly, even the human species. Kung provides a hint at how we might attempt to construct an adequate ethical framework for contemporary problems like genetic engineering. He suggests that a global ethic be "related to reality". I would endorse that suggestion and attempt to broaden it by situating the human story within the larger story of the earth.

In this view a satisfactory ethical framework must be based on our contemporary understanding of the relationship between humans and the rest of the natural world not on the mechanistic world of Newton or Descartes. In the scientific world of the 1980s and 1990s the mechanistic view has being challenged by physicists and biologists. John Polkinghorne, a theologian and former professor of theoretical physics at Queen's College, Cambridge insists that the "world is no mere mechanism. It has a flexibility a suppleness within its process, a freedom for the whole universe to be itself, a freedom for us to act within that universe of which we are a part" (). Our evolutionary history makes it very clear that humans are not disconnected from the rest of nature. Rather we are an integral part of the community of living beings and non-living reality.

Humankind evolved with other creatures during the past few million years and are dependent on plants and animals for our survival. The well-being of the human species depends on the well-being of the whole fabric of nature. If we damage that in an irreversible way, we damage ourselves. So even from the perspective of enlightened self-interest we ought to have respect for the community of living beings as well as the air, water and soils of the earth to ensure our own future.

Much of the moral debate in this area concentrates on the impact of genetic engineering on human beings (). It focuses on whether it will benefit or damage human health. One seldom finds the more fundamental moral questions addressed. For example: Do human beings, as one relatively young species in the community of the living, have the right to interfere in such an intrusive way by introducing exogenous DNA into the genome of another species ? Genetic engineering techniques make it possible to alter, in a significant, way the genetic integrity of any species, be it bacterium, plant or animal. But is it ethically right to do this particularly if the modification is harmful to the animal?

Take the case of genetically engineered salmon. A recent report commissioned by the Marine Institute of Ireland discusses The nature and current status of Transgenetic Atlantic Salmon. The document states that as a result of introducing growth hormone genes into a wild North Atlantic salmon the transgenetic fish grows rapidly and reaches enormous size. Studies show that within a period of 14 months the transgenetic salmon can weigh 37 times more than the ordinary salmon. This increase probably will deliver huge economic benefits to salmon producers. The cost to the salmon is horrendous. In its technical and unemotive language the report notes that the experiment produces "profound morphological abnormalities" in the transgenetic salmon. These included a "disproportionate growth of the head and operculum cartilage, disimproving appearance and leading ultimately to respiratory problems" (). The report never raises the basic question: Do humans have the right to interfere with the genetic integrity of this species of fish?

At this very moment experiments are also being carried out on many other animals in an effort to improve livestock or develop cheap ways of producing drugs. Animal rights groups like Compassion in World Farming are rightly concerned about the suffering which genetic engineering techniques inflict on animals. Today the technology is so imprecise since the expression of the gene depends on the promoters, enhancers and silencer genes. As a result all kinds of abnormalities have occurred including loss of limbs and brain defects. In many situations the transgenetic animal does not pass on the desired gene to its offspring so repeated experiments are necessary in order to develop the desired line for breeding purposes. In reflecting on the potential for increasing animal suffering and creating abnormal creatures Jeremy Rifkin concludes that "The larger lesson is that the complex and multiple interactions between the inserted trangene and the chemical activity of the host animal are, for the most part, unknowable and unpredictable and can result in all sorts of novel and even bizarre pathologies in the creature" (). An ethical assessment of genetic engineering or cloning needs to ask: What would justify such intervention? Would the desire to produce an animal with desirable economic traits like increased growth performance, leaner meat and greater weight justify the operation?

Viewed through an exclusively anthropocentric moral framework the answer may well be, yes. Charles McCarthy an ethicist with the Kennedy Institute for Bioethics at Georgetown University in Washington D.C. writes that " In a utilitarian context, efficiency in food production and ability to compete for world markets stand as high values which must be weighed against our recognised obligations to provide for the interests of the animals" ().

As stated earlier the moral framework, which we inherited from the Greek and Roman culture and a segment of the Judeo-Christian tradition, is not in itself adequate for assessing the ethics of a complex issue like genetically engineering other creatures. The attempt to

widen the moral universe beyond the human domain to include the rights of other species has been underway on the margins of ethical studies for a number of decades.

Writing in 1949 , Aldo Leopold, an American ecologist tried to work out an eco-centred land ethic. He insisted that no progress could be made towards shaping such an ethic until the concept of land is expanded beyond legal and economic domain. According to Leopold, looked at ecologically and ethically, land is a community which includes "soils, waters, plants, and animals, or collectively: the land" ().

Leopold acknowledged that an ethic that might take the above seriously does not preclude using them for human sustenance and welfare. It does however mean that they have a right to continue in existence in some way in their natural state. Leopold formulated his eco-centred principle as follows: " A thing is right when it tends to preserve the integrity, stability and beauty of the biotic community. It is wrong when it tends otherwise" ().

Those associated with the Deep Ecology movement would go further than Leopold in framing ethical norms that regulate human interaction with the rest of nature. Their focus is often called the ecocentric or biocentric approach because they argue that ethics should be concerned about the impact of human behaviour on ecosystems, like rivers and even on the biosphere as a whole, as in the case of global warming. For Deep ecologists ecocentrism is both an ethical imperative and also a programme for political action. They insist that "all things in the biosphere have an equal right to live and blossom and to reach their individual forms of unfolding and self-realisation with the larger Self-Realisation "().

There is no way that Deep Ecology advocates like the Norwegian philosopher Arne Naess, would countenance the kind of experiments carried out on the pigs or the salmon as described above ....... Deep Ecology values non-human life independently of its usefulness to human beings. It is particularly keen on promoting social and ecological policies which involve "non-interference with continuing evolution".

Whilst VOICE might distance itself from some positions espoused by deep ecology, especially those which fail to acknowledge any unique place for human beings in the community of the living, their insistence on the rights of other creatures and the integrity of the ecosystem as a whole must now become the context within which the ethical dimension of biotechnology must be discussed. For example, biotechnologists are now able to eliminate the brooding instinct in turkeys by blocking the gene that produces the prolactin hormone. Non-brooding turkeys are more productive than brooding birds, but is eliminating the mothering instinct in another creature morally justifiable?

VOICE’s position is close to that of Fr. Thomas Berry, an American priest who discusses ecological issues from a cosmological, ethical and religious perspective. He writes that contemporary ethics must focus its concerns on the larger community of the living. He states that "the human community is subordinate to the ecological community. The ecological imperative is not derivative from human ethics. Human ethics is derived from the ecological imperative.

The basic ethical norm is the well-being of the comprehensive community, not the well-being of the human community. The earth is a single ethical system, as the universe is a single ethical system (). This is the first principle of an ecological ethic.

Such an ethic would demand a legal framework where the rights of the geological and biological as well as the human component of the earth community are protected.

Even moral theologians who work within the narrower moral paradigm of the Judeo-Christian tradition are beginning to insist on the intrinsic value of other creatures. Animals and plants are considered to have value merely because they are perceived to be useful to human beings, rather than because they have value in themselves. Taking the notion of intrinsic value as a starting point Professor James A. Nash would be very sceptical about the morality of genetically engineering other creatures. He writes that, since in the Christian tradition other species are deemed to have intrinsic value, the creation of transgenetic species should "not be the norm but the rare exception on which the burden of proof rests. The genetic reconstruction of some species may be justified for compelling human needs in medicine, agriculture or ecological repairs (e.g. oil eating microbes), so long as it can be reasonably tested and verified that tolerable alternatives are not available, genetic diversity is not compromised and ecosystemic integrity is not endangered" ().

In the light of this principle it would be impossible to justify the experiment on the genetically engineered salmon and other animals that are being vigorously promoted by the biotechnology industry today. The distress caused to the animals involved and the right which animals have to preserve their own genetic integrity ought to act as a prohibition against such experiments until there is a much more extensive debate on the issue among the public. From an ethical perspective the nub of the issue revolves around whether other creatures have "intrinsic" value or not. If they do then it seems logical to argue that they have rights that their own 'specialness' especially the species boundary, be respected by another creature. If they do not and are merely objects then, of course, there is no ethical imperative to respect their species uniqueness. Humans can exploit them for any purpose whatever. In the present global commercial climate such exploitation intervention will be driven by what is considered useful, profitable and acceptable for humans.

Following on from an ecocentred approach one can then access the activity in terms of its impact on humans and the environment. The question is, does genetic engineering pose such a threat to human health and the environment that the deliberate release of genetically engineered organisms should not be allowed at this point in time?

The dangers which are posed by the tidal wave of biotechnological products are real. At a meeting in Asilomar in 1975 a group of scientists, drawn from the Committee on Recombinant DNA of the US National Academy of Sciences, which included the Nobel Prize winner, James Watson, warned about the dangers of genetic engineering. They stated that "there is serious concern that some of these artificially recombinant DNA molecules could prove biologically hazardous" (). This conference upheld the moratorium on recombinant DNA experiments which was then in place. Jeremy Rifkins acknowledges that the reason for the moratorium had more to do with the potential legal liabilities of creating bio-hazards than concern for the human health or environmental risks of the new technology ().

Almost 20 years later an international group of scientists meeting in Malaysia in July 1994, called attention to the scientific flaws inherent in the genetic engineering paradigm. They believe that genetic engineering is based on the false premise that each individual feature of an organism is encoded in one or more specific, stable genes and that the transfer of these genes results in the transfer of these discrete features. The truth is that no gene works in isolation but as part of an extremely complex genetic network. In fact the function of each gene is dependent on the context of all the other genes in the genome. The same gene, for example, will have very different effects from individual to individual, because other genes are different.

The scientists who met in Malaysia pointed out that the development of any trait results from many complex interactions between genes and their cellular and external environment. There are numerous layers of feedback mechanisms linking all these levels. These scientists insist that, in a significant number of cases, it is impossible to predict the consequences of transferring a gene from one type of organism to another. Furthermore, genetically engineered organisms, especially micro-organisms, may migrate, mutate and be transferred to other organisms and species. In some cases the stability of affected organisms and ecosystems could be affected and threatened ().

It is for this reason that Dr. Mae-Wan Ho a geneticist, argues that genetic engineering is a crude and imprecise operation and consequently is inhertently hazardous to health and biodiversity. The insertion of a foreign gene into the host genome is a random process, not under the control of the genetic engineer. It is through the use of artificial vectors that the horizontal gene transfer is achieved. The transferred gene can give rise to random genetic effects including cancer (). She believes that the technology will contribute to an increase in the frequency of horizontal transfer of those genes that are responsible for virulence and antibiotic resistance, and allow them to recombine to generate new pathogens ().

Some of the risks to human health and the environment include: the potential to cause allergies; an increase in antibiotic resistance and toxicity; misleading the consumer into thinking that the produce is fresh and, finally, unpredictable gene expression in the engineered organism. A group of scientists in the United States calling themselves the Council for Responsible Genetics have called for a more proactive approach from the regulatory agency which is the Food and Drug Administration (FDA) in monitoring and regulating genetically engineered foods because of these risks.

All allergies are caused by proteins. Genetic engineering involves adding new proteins to altered products. The FDA warns that new proteins in foods might cause allergic reactions in some people. Transgenic crops could bring new allergens into foods that sensitive individuals would not be in a position to avoid. It is possible for example to transfer the gene for one of the many allergenic proteins found in milk into vegetables like carrots. People who ought to avoid milk would not be aware that transgenic carrots contained milk proteins.

The problem is unique to genetic engineering. Genetic engineering routinely moves proteins into the food supply from organisms that have never been consumed as food by human beings. Some of those proteins could be food allergens, since virtually all known food allergens are proteins. Recent research substantiates concerns about genetic engineering rendering previously safe foods allergenic. A study by scientists at the University of Nebraska found that soybeans genetically engineered to contain Brazil-nut proteins caused reactions in individuals allergic to Brazil nuts. Blood serum from people known to be allergic to brazil nuts was tested for the appropriate anti-body response to the gene transferred to the soya bean. When seven out of nine volunteers responded to the genetically engineered soybean the researchers concluded that the allergenicity had been transferred with the transferred gene.

Scientists have a limited ability to predict whether a particular protein will be a food allergen, if consumed by humans. The only sure way to determine whether protein will be an allergen is through experience. Thus importing proteins, particularly from non-food sources, is always a gamble from the point of view of allergenicity. It is generally recognised that there has been a significant rise in allergies, especially among children in recent decades. Since as high as 8 percent of children have allergic reactions to many commonly eaten foods it seems foolish in the extreme to do anything that might increase allergenicity. Many of the genes being transferred to the trangenetic food have never been part of the human diet.

Genetic engineering often uses genes for antibiotic resistance as "selectable markers." Early in the engineering process, these markers help select cells that have taken up foreign genes. Although they have no further use, the genes continue to be expressed in plant tissues. Most genetically engineered plant foods carry fully functioning antibiotic resistant genes. The most commonly used marker genes are the npt11 gene which confers resistance to kanamycin, neomycin and geneticin and the bla gene which confers resistance to ampicillin.

The presence of antibiotic resistant genes in foods could have two harmful effects. First, eating these foods could reduce the effectiveness of antibiotics which are taken with such a meal. Antibiotic resistance genes produce enzymes that can degrade antibiotics. If a tomato with an antibiotic resistant gene is eaten at the same time as an antibiotic, it could destroy the antibiotic in the stomach.

Secondly, the resistant genes could be transferred to human or animal pathogens, making them impervious to antibiotics. If transfer were to occur, it could aggravate the already serious health problem of antibiotic-resistant disease organisms. Although unmediated transfers of genetic material from plants to bacteria is highly unlikely, even a slight risk of this happening requires careful scrutiny in light of the seriousness of antibiotic resistance in the population at large. The discovery by scientists at Cologne University in 1998 that DNA which had been fed to a mouse survived in the digestive system and subsequently invaded other cells in the mouse's body should raise serious questions and slowdown the entry of GE products into the food chain until there is much more research on their ultimate impact on human health ().

It is also true that the highly mosaic character of most vector constructs makes them structurally unstable and prone to recombination. According to scientists opposed to genetic engineering this may be why viral-resistant transgenic plants generate recombinant viruses more readily than non-trangenetic plants ().

Many organisms have the ability to produce toxic substances. These substances help the organism defend itself against many predators in their environment. In some cases, plants contain inactive pathways leading to toxic substances. The addition of new genetic material, through genetic engineering, could reactivate these inactive pathways. Alternatively it could increase the levels of toxic substances within the plants. This could happen, for example, if the on/off signals associated with the introduced gene were located on the genome in places where they could turn on the previously inactive genes. In the light of these considerations many argue that genetically engineered foods pose new and unique challenges in terms of food safety.

Some of the new genes being added to crops can remove heavy metals like mercury from the soil and concentrate them in the plant tissue. The purpose of creating such crops is to make possible the use of municipal sludge as fertiliser. Sludge contains useful plant nutrients, but often cannot be used as fertiliser because it is contaminated with toxic heavy metals. The idea is to engineer plants to remove and sequester those metals in inedible parts of plants. In a tomato, for example, the metals would be concentrated in the roots; in potatoes in the leaves. Turning on the genes in only some parts of the plants requires the use of genetic on/off switches that turn on only in specific tissues, like leaves.

Such products pose risks of contaminating foods with high levels of toxic metals if the on/off switches are not completely turned off in edible tissues. There are also environmental risks associated with the handling and disposal of the metal-contaminated parts of plants after harvesting. This is a classic example of a technological fix for an environmental problem that ought to be addressed at its source. The way to guarantee that sewage sludge can be used in agriculture is to ensure that toxic substances do not enter sewerage plants in the first instance.

Most of the focus on health hazards associated with genetic engineering stem from considering the genetic material that is added to organisms. There is also the possibility that the removal of genes can cause problems. For example, genetic engineering might be used to produce decaffeinated coffee beans by deleting or turning off genes associated with the production of caffeine. But caffeine helps protect coffee beans against fungi. Beans that are unable to produce caffeine might be coated with fungi, which can produce toxins. Fungal toxins, such as aflatoxin, are potent human toxins that can remain active through processes of food preparation. Finally it is worth noting that the FDA is concerned that toxins may be produced at unusually high levels as a result of genetic engineering.

A possible consequence of genetically engineered foods is an alteration of the nutritional content of the resulting product. The FDA cautions that nutritional value could be significantly decreased without the crop exhibiting any outward signs. Humans have come to rely on certain characteristics of fruits and vegetables to indicate nutritional quality and flavour. For example, bright colour in peppers, apples and other fruits is generally associated with taste and ripeness. Genetic engineering may mislead consumers into buying fruits and vegetables which appear to be fresh and just about ripe, but in fact are engineered to last longer on the shelf and as a consequence may lack nutritional quality. This would have serious implications for public health and needs to be taken on board by monitoring and regulatory agencies.

History has shown that it takes a few decades for the full set of risks associated with any technology to be identified. In the 1920s no one predicted that CFCs could cause such harm to the ozone layer. The ability to imagine what might go wrong with genetic engineering is limited by the current knowledge in such disciplines as physiology, genetics, and nutrition.

We should not forget too quickly how pressures from the food industry and government agencies led to the failure of the UK authorities to link BSE with a new variant of the incurable human condition CJD. Those who raised questions about this connection in the mid-1980s were often criticised and even ridiculed by their colleagues. Dr. Tim Holt, a Yorkshire doctor, told a UK government enquiry into BSE how a pathologist at the Government's central veterinary laboratory investigating mad cow disease said that the transmission to humans was as "unlikely as a being struck by lightening"(). Finally, whereas with other technologies mistakes can be rectified by redesigning the machinery, mistakes in the area of genetic engineering are much more difficult to correct.

The need for caution is highlighted by the controversy surrounding the production of transgenetic pigs to provide organs for human transplant operations. Companies on both sides of the Atlantic have engineered pigs to carry human protein on the surface of their cells so that the organs will not be rejected by the human immune system. At first glance this seems to be a brilliant way of meeting the demand for organs for transplant operations. Unfortunately, researchers have found that the pigs can carry at least two retroviruses. One of these has the potential to infect human cells. Even though the US Food and Drug Administration (FDA) have been provided with the results of the research they have continued to allow the transplants to take place. One of the researchers involved felt that the least the FDA should have done is ban the transplants (). Given the presence of these viruses many scientists would argue that pig organs can never be a safe replacement for human lives ().

Genes form a holistic system, with one gene affecting multiple traits and multiple genes affecting one trait. Consequently, scientists cannot always predict how a single gene will be expressed in a new system. For example, splicing a gene for human growth hormones into mice produces very large mice; splicing the same gene into pigs produces skinny, cross-eyed, arthritic animals. The FDA warns that splicing a single gene into an organism for a single desired effect may unintentionally cause other harmful reactions within that organism which are not detectable.

Organisms engineered to grow under adverse conditions run the risk of becoming weeds directly or by breeding with wild relatives. Here, weeds means all plants which are found in places where humans do not want them. In each case, the plants are found growing unaided and have unwanted effects as far as the farmer is concerned. If genetically engineered plants become weeds this could damage large tracks of agricultural lands, severely limit crop yields and cause immeasurable destruction to sensitive ecosystems.

Some weeds result from the accidental introduction of alien plants, but many are the result of organisms introduced for agricultural and horticultural purposes. Johnson grass which was intentionally introduced by the United States has become serious weeds. In Britain minks that have escaped from captivity have proliferated and has caused serious damage since they have no natural predator in that environment. In the Galapagos Islands feral cats have wrecked havoc on the defenceless island fauna. In Africa the South American Water Hyacinth has choked freshwater habitats. A new combination of traits, produced as a result of genetic engineering, might enable crops to thrive in an environment in which they would then be considered a weed. One example would be a rice plant engineered to be salt-tolerant that escaped cultivation and invaded nearby marine estuaries. The possibility that this will happen increases as more and more genetically engineered organisms are released into the environment.

Biotech scientists and regulators often dismiss the possibility of genetically engineered crops becoming super weeds because they argue that most staple crops have been so weakened genetically by the domestication process that the addition of an engineered trait will not enhance their competitiveness. While this might be true for a crop like corn many other crops like alfafa, barley, potatoes, wheat, sorghum, brocolli, cabbage and radishes do retain their weedy traits.

For example, a gene that would change the oil composition of a crop might move into nearby weedy relatives thus enabling the weed to survive harsh winters and become much more of a nuisance to farmers. This is why Dr. Margaret Mellon, a molecular biologist, and Dr. Jane Rissler, a plant pathologist both of whom work with the Union of Concerned Scientists in the US argue that the "possibility that engineering will convert crops into new weeds is a major risk of genetic engineering" ().

Even more serious is the danger of what is called "gene flow". This refers to the possibility of transferring a gene from a transgenetic plant to a weedy relative by way of cross-pollination. Novel genes placed in crops will not necessarily stay in the fields in which they are planted. If relatives of the altered crops are growing near the field, the new gene can easily move, via pollen, into those plants. The new traits might confer on to the wild or weedy relatives of crop plants the ability to thrive in unwanted places, making them weeds as defined above. If a herbicide resistant gene jumped to a wild weedy relative then that plant might become resistant to the particular herbicide. This form of genetic pollution might easily become a major nuisance to farmers world wide.

When genetically engineered oilseed rape is planted in Europe in 1999 many fear that "herbicide-tolerant rape will undoubtedly become part of the established volunteer weed populations that occur in many cereal rotations..." (). The infestation may occur even where farmers do not grow the GE rape themselves. It can happen that a GE oilseed rape grown in an adjacent field can pollinate plants in a neighbouring field and produce seeds that are herbicide tolerant.

Mistakes can also happen as the following two examples demonstrate. In the late 1980s a company called Biotechnica International genetically engineered a micro-organism (Bradyrhizobium japonica) to improve nitrogen fixation in plants. The company contracted the Louisiana Agricultural Experiment Station to conduct field trials for one year by planting soybeans coated with the genetically engineered rhizobia. After the experiment the plants and seeds were incinerated, the fields were reploughed and replanted and Biotechnica ceased to have anything to do with the field trials. However, subsequent trials on that land revealed that the genetically engineered rhyzobia were out-competing the indigenous strain. This was not expected to happen. The act of reploughing the area, rather than helping, in fact spread the genetically engineered rhyzobia over a four acre plot. The case illustrates the unpredictability of genetically engineered experiments according to one scientist. " One of the major considerations about this case is that a microbe for which there existed an extensive historical database was used in a well-planned and thoroughly reviewed experiment, and an unpredictable result was still obtained" ().

A genetically engineered bacterium (Klebsiella) was found to produce dramatic changes in the soil food web and therefore inhibit plant growth. The bacteria was engineered to produce ethanol from agricultural waste as a way of generating fuel. But when added to the soil it was found that it produced a significant decrease in growth in both roots and the shoots of wheat. There was also a decrease in beneficial soil fungi, an increase in parasitic nematodes and bacteria. Stopping the spread of such a bacteria, once released, will be very difficult ().

A second major environmental concern is the increased use of herbicides. Over half of the crops currently under development are those engineered for herbicide resistance, permitting increased use of these harmful chemicals. The permission granted by the EPA in Ireland to Monsanto Ireland Ltd, to conduct field trial sugar beet that has been genetically engineered to be resistant to the herbicide Roundup in Ireland in 1997 & 1998, raises questions about the nature of these herbicides and their increased use.

The company claims that even after long-term application there is no effect on the environment. It is marketed as an environmentally-friendly herbicide. Such claims need to be thoroughly scrutinised. It is a broad spectrum non-selective herbicide which kills all plants, including grasses, broadleaf's and woody plants. The active agent in Roundup, glyphosate is an organophosphate. Unlike other organophosphates it does not affect the nervous system of animals. But that does not make it environmentally friendly.

Critics of Monsanto point out that it is very difficult to measure the glyphosate residue in the environment. Only a few laboratories have the sophisticated equipment and expertise necessary. This means that data is often lacking on residue levels in food and in the environment and existing data may not be fully reliable.

While the acute toxicity of glyphosate for mammals is very low, it can interfere with some enzyme functions in animals. In California glyphosate is the third most commonly reported cause of pesticide related illness among agricultural workers. Glyphosate causes damage to the environment. Many species of wild plants are damaged or killed by applications of less than 10 micrograms per plant. These plants are particularly vulnerable when it is spread from the air. Fish and invertebrates are also very sensitive to formulations of glyphosate.

At the moment there is evidence that plants that are grown in the presence of weed-killers can suffer from stress. They react by producing or failing to produce certain proteins or substances. Members of the bean family produce higher levels of plant-oestrogens (phyto-oestogens) when grown in the presence of glyphosate. Excessive levels of these oestrogens present a risk to children. These plant-oestrogens mimic the role of hormones in the human body. They can be particularly disruptive of the human reproductive system, especially for young males ().

There is also good reason to be sceptical about claims that genetically engineered plants will lead to fewer chemicals in agriculture. In soybean cultivation Monsanto maintained, in documents prepared for the US authorities, that it now takes between one and five applications of different herbicides to control weeds. With Roundup only one or, possibly, two applications will be needed. Yet in their advice to farmers in Argentina, Monsanto recommended that Roundup be used with Roundup Ready soybeans before sowing, when the plants are young, after three or four leaves have appeared and whenever the farmer finds weeds. This is quite a different scenario (). Something similar has happened with AgrEvo's genetically engineered oilseed rape which is resistant to the herbicide glufosinate which is destined to be planted in Europe in 1999. The company has increased the production facilities for glufosinate in the US and Germany and expects sales to increase in the next five to seven years. In fact it is alleged that the reason that AgrEvo has entered into the GE market is to boost its herbicide sales ().

In January 1997 Monsanto agreed to change its advertising for glyphosate-based products, including RoundUp, in response to complaints by the New York Attorney General's office that the ads were misleading. As part of the agreement, Monsanto will not use the term 'biodegradable' or 'environmentally friendly' in its advertisements for glyphosate-based products in New York State. They also agreed to pay $50,000 towards the State's cost for pursuing the case. Monsanto claims it did not violate any federal, state or local law and that its claims were 'true and not misleading in any way'. The company states that it entered into the agreement for settlement purposes only in order to avoid costly litigation (). In November 1997 the Dutch Advertisement Code Committee (ACC) found that Monsanto’s advertisements for RoundUp were misleading. The ACC judged that Monsanto’s herbicide is not biologically degradable and that their ECO claim is in conflict with the truth.

Companies like Monsanto claim that by producing crops that are resistant to herbicide they will reduce the amount of harmful chemicals entering the environment. They fail to inform the public that it is also a very cost effective operation for the company. At present it cost between $40 million and $100 million to bring a new pesticide through the regulatory process to the farmers fields. It only takes $1 million to develop a new plant variety. Pat Mooney believes that "economics dictate that chemical companies invent new crop varieties adaptable to the company's chemicals rather than adapt expensive pesticides to the inexpensive seeds" ().

Genetic engineering also threatens biodiversity. The UK Advisory Committee on Releases to the Environment is concerned that when crops, which are genetically engineered to be resistant to herbicides, become common they will have a devastating impact on wildlife. Fields of genetically engineered crops could lead to starvation for birds and insects that depend on these seeds as a source of food. The committee's chairman, John Beringer, Professor of Molecular Genetics at Bristol University, said that "It could be cranking up the pressure on species if this technology proceeds to the limits" ().

Many insects contain genes that render them susceptible to pesticides. Often these susceptible genes predominate in natural populations of insects. These genes are a valuable natural resource because they allow pesticides to remain as effective pest-control tools. The more benign the pesticide, the more valuable the genes that make pests susceptible to it.

Certain genetically engineered crops threaten the continued susceptibility of pests to one of nature's most valuable pesticides: the Bacillus thuringiensis or Bt toxin. These Bt crops are genetically engineered to contain a gene for the Bt toxin. Because the crops produce the toxin in most plant tissues throughout the life cycle of the plant, pests are constantly exposed to it. This continuous exposure, in time, will render the Bt pesticide useless, unless specific measures are instituted to avoid the development of such resistance.

In fact in both laboratory and field situations a number of species, including the Colorado potato beetle have developed a resistance to the Bt. toxin. In 1996 Monsanto's Nu Corn which contained the Bt toxin failed to perform as expected due to hot weather and drought conditions. Even in field test the genetically engineered gene killed only 80 percent of the bollworms that attack cotton. The fact that 20 percent survived means that a "super bug" will almost inevitable emerge.

On the larger stage Vandana Shiva claims that genetically engineering even at present is working against crop diversity and narrowing the genetic base of agriculture to only a few crops. In 1998 two commercially staple crops were being genetically engineered - soya and maze. In comparison to the hundreds of legumes and beans eaten around the world there is only one GE soya. Will the great variety disappear in the face of genetically engineered crops as happened already during the Green Revolution. In the places of different varieties of cereals - millets, wheat and rice there in only one genetically engineered variety of maze. She goes on to point out that genetically engineered crops are based on expanding monocultures of the same variety which have been developed for a single function. As the biotechnology industry takes root in different countries this monoculture tendency will continue, further undermining agricultural biodiversity and, thereby creating ecological vulnerability.

The addition of foreign genes to plants could also have serious consequences for wildlife in a number of circumstances. For example, engineering crop plants, such as tobacco or rice, to produce plastics or pharmaceuticals could endanger mice or deer who consume crop debris left in the fields after harvesting. Fish that have been engineered to contain metal-sequestering proteins (such fish have been suggested as living pollution clean-up devices) could be harmful if consumed by other fish or racoons.

One of the most common applications of genetic engineering is the production of virus-tolerant crops. Such crops are produced by engineering components of viruses into the plant genomes. For reasons not well understood, plants producing viral components on their own are resistant to subsequent infection by those viruses. Such plants, however, pose other risks of creating new or worse viruses through recombination.

Recombination can occur between the plant-produced viral genes and closely related genes of incoming viruses. Such recombination may produce viruses that can infect a wider range of hosts or that may be more virulent than the parent viruses.

In the late 1980s the National Institute of Allergy in the US sought an animal model suitable for studying AIDs. Researchers introduced the AIDs virus into mice. Critics of the experiment feared that if the AIDs infected mice escaped this could create a new and even more deadly source of AIDs infection. Those conducting the experiment dismissed such fear as unfounded and alarmist. A study conducted by the Dr. Robert Gallo, one of the co-discoverers of the AIDs virus, and subsequently published in the magazine Science, cautioned against using animal research models. He and his colleagues argued that the AIDs virus carried by the experimental mice might combine with other viruses that are carried by mice. This could result in the creation of a new more virulent form of AIDs that could be transmitted in novel ways, even through the air ().

On the social level there is the concern that genetically engineered crops will displace crops grown naturally by farmers in Third World countries and in the process disrupt the lives of millions of poor people. In the US two biotechnology companies have produced vanilla from plant cell cultures in laboratories. The price of naturally produced vanilla is about $1,200 per pound. The biotechnology companies estimate that they can commercially produce genetically engineered vanilla for about $50 per pound. Such a development would wipe out the livelihood of about 100,000 farmers in Third World countries. 70,000 alone live in Madagascar.

Such developments would constitute a economic disaster for many Southern countries where biodiversity is already under severe strain. Similar research is under way to genetically engineer crops that are crucial to Third World economies. These include coffee, tobacco, cocoa, coconut, palm oil, sugar and ginseng. Genetically engineered varieties may thrive in temperate zones and thus ravage many Third World economies which are dependent on one or other of these commodities. These poor, debt-burdened countries and have no fall-back industries capable of absorbing their redundant farmers. It is also interesting that there is very little transfer of genetic engineering technology from First World the transnational corporations to Third World countries. The World Bank Panel on Transgenic Crops concluded that technology transfer between transnational corporations and less developed countries were so rare that the examples they cited were exceptional ().

As with human health risks, it is unlikely that all the potential risks to the environment have been identified. At this point, biology and ecology are too poorly understood to be certain that scientists can comprehensively rule out any major and irreversible damage to the environment. Therefore we should proceed with extreme caution. This point was made forcibly by Robin Grove-White, Director of the Study of Environmental Change, Lancaster University, in a letter to the Independent (June 14, 1998) in the wake of Prince Charles's article on genetic engineering which appeared in the Daily Telegraph ( June 8, 1998) the previous week. Mr. Grove-White wrote that "Last year, in a study sponsored, to its credit, by Unilever (itself a potential beneficiary of the technology), we found that the panoply of ministerial advisory committees and other regulatory mechanisms is failing utterly to engage with issues of central significance to most people- particularly, the unknowns surrounding future cumulative dependency on genetically engineered crops and foods, with the risks of unforeseen( because unforeseeable in terms of current scientific understanding) synergies and ecological or public health mishaps".

Given that these risks are potentially so destructive on many fronts, the research, production and especially the deliberate release of genetically engineered organisms ought to be governed by the precautionary principle. This asserts that an action which is risky and could possibly cause widespread and irreversible damage should not be pursued, especially when there is lack of full scientific certainty about the outcome of the action on the organism itself and the wider environment.

Take for example the experiment which biotechnologists are now involved in at Newcastle University in Britain. Ruminant animals, like cattle, produce enzymes in their gut which break down cellulose plants into basic sugar components which are then assimilated by the animal. Now the biotechnologists are experimenting with introducing cellulose genes directly into non-ruminant animals, like pigs and chickens. Their aim is to produce the "grazing" pig. Whether this would be good for the pigs, given that the rest of their physiology does not suit grazing behaviour, or for the soil structure, is not at all clear. The presumption based on present knowledge, is that it would not, and therefore the precautionary principle ought to be invoked.

Introducing genetically engineered organisms into the environment is very different from introducing other technological inventions. If a chemical and mechanical invention proves dangerous it can be recalled or eliminated. This is not so with genetically engineered organisms. Even if only one percent of these organisms wreak havoc on the environment the consequences could be significant and irreversible because the organism will continue to reproduce and thrive. Even before the advent of genetic engineering, exotic species which have been introduced into an ecosystem have wiped out indigenous species and interfered with the complex web of relationships which exist between organisms in a complex environment.

Because the dangers are so great the Council for Responsible Genetics in the United States believes that the time has come for the Food and Drug Administration (FDA) to re-evaluate its position on genetically engineered foods, and for citizens to demand a consumer-centred regulatory policy. The essential elements in such a policy ought to include;

Testing is crucial. If you do not look for something you will not find it. Industry and government spokespersons have been assuring the public that genetically engineered organism are safe. They fail to inform the public that the testing regime is woefully inadequate. In 1998 the US Department of Agriculture is still only spending one percent of the funds allocated to biotechnology research on risk assessment ().

In 1997 two researchers Allison Snow and Pedro Moran Palma criticised the adequacy of the current field-testing procedures. They argue that since the tests are designed in such a way to rule out "gene flow" by insisting on early harvesting or bagging the flowers they are not adequate to access the major risk associated with a large scale commercial planting of the transgenetic crop. Furthermore, the fact that the experimental area is small and the time scale is limited to one or at the most a few harvests means that there is little possibility of accessing the long-term negative impact on microorganisms, insects and plants ().

Genetic engineering needs to be treated as the novel process that it is. Regulations ought to be much more demanding and rigorous. Independent verification must be built into the process so that the regulatory agencies can regain public trust.

Many environmental and consumer groups are very unhappy with national and international regulatory agencies. In the US for example, despite all these problems and the cautions by the FDA, the existing regime, in most cases, is that genetically engineered products do not require a pre-market approval process, public notification, or any labelling whatsoever to inform consumers of their novel and possibly harmful characteristics. The fact that The Council For Responsible Genetics claims that a precautionary "safety proven first" policy has been scrapped in favour of corporate economic interests is very serious indeed.

Industry is essentially placed on an "honour system," deciding when and whether to consult with the FDA. Companies conduct safety tests for their own bio-engineered products, notifying the FDA only if they suspect a problem. If they perceive no danger to consumers, companies are not required to state that their product has been genetically manipulated or to reveal the source of implanted genes. They are not required to make the results of their safety tests available to the public. The FDA will not have a complete set of information regarding genetically engineered foods on the market, so there will be no way to trace who or what is responsible should a problem occur. Not only does the FDA policy forfeit consumers' right to know how their food has been manufactured, it also impedes the public's right to safe and tested food products by allowing the companies who profit from biotechnology to decide if and when a product is hazardous.

The basis of this policy is the inaccurate premise that genetic engineering is only a minor extension of traditional breeding, not significant enough to warrant a unique policy for this technology. The bio-engineering industry has opted for the term genetic modification rather than genetic engineering in an effort to convince the public that genetic engineering is in continuity with the processes of selective breeding that have been practised by human societies since the domestication of plants and animals over 11 thousand years ago.

In reality genetic engineering is quite different as we have seen. It operates by transferring specific genes directly into the product-organism itself, eliminating the role of parents and reproduction. Since the Neolithic revolution animal and plant breeding was always constrained by the limits imposed by species boundaries found in nature itself.

Genetic engineering circumvents the whole species barriers. It allows for the addition or deletion of proteins in ways not possible through reproduction, creating organisms which are missing essential proteins or harbouring entirely new ones. Genetic engineering brings together genetic material in a way nature never would do. Nevertheless the FDA chose to treat transferred genes as natural food products as long as they come from an approved food source, thereby failing to consider the unpredictable effects which the old gene may have in its new system.

At the international level the joint Safety Report on genetically-engineered foods issued in 1996 by the Food and Agriculture Organisation (FAO) and the World Health Organisation (WHO) decided that the WHOs Codex Alimentarius Commission will decide on the safety of genetically engineered foods. Risk assessment will be based on the "principle of substantial equivalence" which has been roundly criticised by many scientists as totally inadequate. The tests for substantial equivalence are so undiscriminating that according to Dr. Mae-Wan Ho "unintended changes, such as toxins and allergens, could easily escape detection" ().

More worrying still consumer and environmental groups also claim that Monsanto, and other corporations, have successfully co-opted national and regulatory agencies to promote their agenda. According to the St. Louis Post a current Monsanto vice-president is tipped to become the next Commissioner of the Food and Drugs Administration (FDA) in the United States. The revolving door syndrome whereby high ranking personnel from the corporate world move into critical positions in the FDA and then back to industry raises questions about the thoroughness and impartiality of the FDA and other regulatory bodies.

George Monbiot writing in The Guardian about the FDA's handling of Monsanto observes that "the administration has approved some of the company's most controversial products, including the artificial sweetener aspartame and the injectable growth hormone for cattle. Only the New York Attorney General's office has taken the company to task, forcing it to withdraw adverts claiming that Roundup is biodegradable and environmentally friendly" ().

Later in 1997 The Guardian reporters John Vidal and Mark Milner substantiated these criticisms of the regulatory agencies in the final article of a four-day special on biotechnology and food. They found:

* A revolving door between the US government and the biotech industry.

* Heavy lobbying to rewrite world food safety standards in favour of biotechnology ().

* New laws protecting the US food industry from criticism.

A further cause for worry is that the corporate reach has moved far beyond the national boundaries to include the decision making process of multilateral organisations like the World Trade Organisation (WT0). Monsanto has successfully elicited a ruling from the WTO that will make it impossible for the European Union to ban the importation of meat and milk from animals which have been treated with bovine growth hormones even though European consumers, environmentalists and farmers are opposed to such a move.

Consumer confidence is further damaged by claims in Scientific America that Monsanto's clinical trials of the drug were incompletely analysed. This obscured the fact that it increased the number of infected udder cells in the cows by about 20 per cent ().

GeneWatch lists some of the difficulties associated with the current testing regime. These include the fact that:

* there is little experience to draw on. All the environmental data so far has been derived from small scale field trials.

* extrapolating to the wider environment inevitably brings considerable scientific uncertainty given varying climatic and agricultural practices.

* most trials are designed to evaluate the agronomic characteristics (e.g. yield) rather than the ecological impact.

* studies are currently conducted on a case-by-case basis neglecting the potential for cumulative impacts (e.g. as ever increasing numbers of herbicide resistant crops are grown).

* with regard to human health, testing has to date relied on laboratory studies with laboratory species ().

In May 1998 consumer groups, a number of biologists from the University of California and the University of Minnesota, a rabbi, a Protestant minister and a prominent New York restaurant chef filed suit in Washington against FDA policies on genetically engineered foods. They claimed that the FDA had not fully assessed the health risks to consumers and that the regulators had been too eager to let companies market genetically engineered foods without requiring safety tests, or at least, special labels.

The FDA must require industry to notify them when any genetically engineered food goes on the market. In the event of problems, this would provide a "trail" for scientists, medical personnel and regulators to follow in order to determine the origins of an unsafe product.

Opinion polls in Europe and elsewhere indicate the public want clear and informative labelling of genetically engineered foods. A basic step in honouring this consumer preference is to segregate genetically engineered foods from natural foods at the source. Many of the corporations that produce genetically engineered foods are opposed to segregation and labelling. They claim that it would be too expensive since it would involve using different containers, trucks and warehouses. They protest that their products are safe and have latched on to the concept of 'substantial equivalence' developed by the Organisation for Economic Co-operation and Development (OECD). This means that "if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety" ().

The focus here is not on how the food was produced, whether from natural or genetically engineered seeds, but on the chemical nature of the food. Should a chemical analysis of the food or food ingredient find that the product is substantially the same as the naturally produced one, no label should be required on safety grounds. In fact no label should be used at all as this might be interpreted as discriminating against genetically produced foods. According to the agribusiness corporations genetically engineered foods are no different from naturally produced food.

However, consumer groups and scientists are unhappy with the notion of substantial equivalence. They cite the process which led to the BSE epidemic and argue that sheep products fed as protein supplement to cattle would probably have passed the substantial equivalence test, yet the presence of prion proteins led to a public health disaster. Worries about toxicity and allergenicity which have been highlighted earlier might not turn up in laboratory experiments for substantial equivalence.

It is clear from a Guardian poll in June 1998 that people want to know whether the food they eat is derived from genetically engineered products. In response to the question whether "foods that have been genetically modified should be clearly labelled", 96 percent answered Yes. In 1997 a similar opinion poll in the US commissioned by Novartis found that 97 percent wanted all biotech food labelled. The Irish Department of the Environment's Consultation Paper recognises that "from a consumer point of view, the information currently being provided is inadequate to facilitate clear choices on whether or not to purchase products containing GMOs or products using genetic modification techniques" ().

The only way to achieve this in a satisfactory way is to segregate genetically engineered food at source. Otherwise there will be problems, even if mandatory labelling for genetically engineered food is introduced. Without segregation, for example, tomato paste from genetically engineered tomatoes would have to be labelled, but a processed food like lasagne which contained genetically engineered tomatoes would need no label. Mandatory labelling of all genetically engineered food products should be required by law and not left to the retail outlets.

Segregation and clear labelling is the minimum requirement necessary to ensure product safety and protect a consumer's right to choose whether or not to purchase these products. Consumer groups all over Europe and the United States are calling for such a system. Once again in the matter of labelling the public are poorly served by the regulatory Agencies. In response to the research that a soybean that contained a Brazil nut gene caused an allergic response in the trial group an editorial in the prestigious medical magazine The New England Journal of Medicine chided the FDA in the U.S for its unwillingness to demand verifiable and across-the-board labelling. The editors stated that it appeared that the FDA "favour industry over consumer protection" ().

The decision by some retail outlets to label with the words 'may contain genetically modified products' means very little. If there is no segregation almost all processed food might contain some genetically modified substances. In practice this would prevent the consumer from exercising their choice of choosing foods that are not genetically engineered.

It should not come as a surprise that many biotech companies have opposed segregation and mandatory labelling. The companies know that, in a post-BSE world, the public want to know where and how their food is produced. Many consumers are willing to pay extra to ensure that the products they buy are produced naturally. This would be bad news for the biotech industry. Given the huge investment which companies like Monsanto have made they need to gain significant market share quickly or else cash-flow problems will send their shares tumbling on the stock market.

Monsanto went on a buying spree in 1996 and 1997 and invested $2 billion buying up dozens of biotech companies, including Calgene of Flavr Savr, in order to gain control of their research patents. Many believe that their ultimate aim is to produce and patent genetically engineered varieties of all staple food crops. These new crops are created to out-produce existing varieties and might be expected to dominate this particular market globally within a short period of time. In the process farmers will become reliant on the patented seeds of the biotechnology industry. The industry has now developed seeds that will not germinate when replanted. A patent on this process has been taken out by the US Department of Agriculture and Delta and Pine a US seed company. This will surely be the death knell for the 1.4 billion small, subsistence farmers who live mainly in the Third World ().

After buying out or taking control of many small, innovative biotech companies Monsanto turned its attention to large seed distribution corporations. In 1997 Monsanto bought Holden's Foundations Seeds for $1.2 billion. A year later in June 1998 it paid a record £843 million for Cargill Inc's. This huge agribusiness has sales and distribution networks in 51 countries on four continents. This acquisition will give Monsanto huge control of global seed markets. It will also become the conduit for distributing their GE seeds. Farmers will have very little option but to buy these GE products (). Within a few short years the transition to GE crops will be accomplished. If the strategy works, the profits for Monsanto will be astronomical.

No wonder that the Guardian correspondent, George Monbiot fears that "with astonishing rapidity a tiny handful of companies is coming to govern the development, production, processing and marketing of our most fundamental commodity: food. The power and strategic control they are amassing will make the oil industry look like a cornershop" (Guardian, Sept 17, 1997). It is frightening to think that within a few years the world's food supply could be dominated by 11 or less giant Northern controlled agribusiness corporations. In 1998, 81 percent of the global agrochemical market is controlled by 10 companies. The stakes in the present scramble for market share in genetically engineered products are enormous. The global market for one year is estimated to be worth $400 billion ().

Monsanto have engaged in a high wire financial operation which could end in disaster. They have chosen a risky option in putting most of their financial eggs into the biotechnology basket. If consumers shy away from genetically engineered food this could prove very costly for biotech companies, especially Monsanto.

Writing in the business section of The Independent on Sunday (May 12, 1996) Paul Rodgers agrees that biotech companies have been the darling of the stock market in recent times. But he strikes a note of caution. He quoted a market analyst Peter Doyle who says he "is surprised by the values attributed to companies on the basis of prospects rather than products".

This explains the headlong rush to get genetically engineered products onto the supermarket shelves as soon as possible. Yet this may prove more difficult than we have been led to expect. For every genetically engineered product that has a commercial value there are 20 or more that simply fail. By mid-1998 the Biotech Companies were experiencing some organisational difficulties and were are beginning to slip again on the Stock Markets ().

This is why companies like Monsanto are desperate for results in order to turn their investment into a steady flow of profits. There is nothing wrong with seeking profit. However one must realise that biotechnology is different from any other enterprise, because it has the power to transform life itself. Governments that are elected to promote the well-being of their citizens should be wary about the risks involved and should regulate and monitor the industry to protect the health of the people and the environment.

We should be resolute in our determination to protect the healthy image of food production here in Ireland. Ireland has a reputation for clean, green and fresh food. This reputation has been seriously damaged by outbreaks of BSE and the use of growth hormones in recent years. It would be folly at this point to allow genetically engineered food to be grown and further erode our green image. If something went wrong this would spell disaster for the whole Irish food industry.

One might ask who benefits from these experiments? Is it the consumer? Are they demanding this kind of technology? The answer would seem to be a resounding no. Mr. John McKenna, a food writer, told the Irish Association of Health Stores that the consumers do not want GMOs in their food. "There is no demand from any quarter other than the producers of GM0 food" ( The Irish Times, Oct 20. 1997). It started as a trickle a few years ago. Now the consumer is faced with a flood of genetically modified organisms appearing on the supermarket shelves. The range covers foods that contain genetically engineered rapeseed oil, soybeans, maize, sugar beet, squash. potatoes and cucumber. More than half the processed foods on the supermarket shelves contain soya in one form or another. An opinion poll carried out by The Guardian in Britain in June 1998 found that 50 percent of those asked were not happy with the introduction of genetically modified foods, while only 14 percent were happy.

Despite their resistance consumers are left with little choice. Many companies that sell soybean, for example, have refused to segregate genetically engineered soybeans from ordinary soybeans. As a result the consumer is being forced to eat food that is genetically modified often without knowing that the product contains genetically engineered soya.

One Supermarket chain Iceland with 770 stores in Britain and 6 in Ireland has decided to ban all foods containing genetically engineered organisms. The founder and chief executive, Malcolm Walker, has accused biotechnology companies of "conning" Irish and British consumers and claimed that genetically engineered food is being introduced "by stealth". Health Food shops in Britain are also determined to rid the shelves of produce which might contain GE ingredients. The policy will include sauce mixes and vegetarian burger mixes ().

Other giant stores like Sainsbury and Tesco have not taken such a strong stand against genetically engineered food. Sainsbury says it has managed to source non GM soya for all 30-45 of its products, which will be labelled from next month (July 1998). This does not include ingredients derived from genetically modified foods in which the DNA or protein is no longer dectable such as soya oil (). Unfortunately, none of the Irish supermarket chains taken such a clear stance, although Superquinn is considering introducing a range of products which are guaranteed not to be genetically modified. ().

So if the pressure to grow and eat genetically engineered food is not coming from the consumer, where is it coming from? Both John McKenna and Dr. Eddie Walsh of UCD agree that the push is coming from biotech companies like Monsanto that have invested huge amounts of money and stand to make the most out of the technology ().

Transnational Corporations with financial resources greater than many countries are poised to make huge profits if the biotechnology enterprise prospers and replaces other more traditional technologies in agriculture and medicine. It is worth pointing out that according to the United States Department of Agriculture 98 per cent of the modifications have been undertaken for commercial reasons. This includes extending the shelf-life of a product as in the case of the Flavor Savr tomato or making crops resistant to a patented herbicide. Virtually none of the modifications are designed to improve nutrition.

Given the huge financial stakes involved it is understandable that all the stops are being pulled out in this battle for control of food production. The biotechnology industry has retained the services of a global PR company Burson Marsteller. This company specialises in crisis management and handling difficult or unsavoury situations. For example it advised Babcock and Wilcox, the builders of the Three Mile Island nuclear installation in the US, during the crisis in 1979. It also helped Union Carbide manage publicity in the aftermath of the Bhopal tragedy which killed over 1500. Among its clients, in recent times where the repressive regimes in Indonesia, Argentina and South Korea.

In a document which was leaked to the Press in August 1997 Burston Marsteller advised the biotech companies "that they cannot hope to win the arguments over the risks posed by genetically modified food, including the environmental dangers ( The Guardian August 6, 1997). The biotech companies were advised to focus on "symbols", not logic". These symbols ought to elicit "hope, satisfaction, caring and self-esteem".

The biotechnology industry promotes this new enterprise by pointing to the benefits it will bring to human beings in the area of food production and health care. Their claim that genetically engineered food will feed the world is ill-founded and naive. The agribusiness companies argue that genetic engineering is a further improvement on the Green Revolution which in the 1960s and 1970s saved Asia from starvation.

Dr. Vandana Shiva in response to a letter from Norman Borlaug, considered by many to be the father of the Green Revolution, debunks many of the myths surrounding the Green Revolution. Dr. Shiva challenges the first myth that India was unable to feed itself until the Green Revolution was launched. She points out that the last famine in India took place in 1942 during British rule. She accepts that India experienced a severe drought in 1966 and was forced to import 10 thousand tons of grain from the US. She indicts the US administration who "exploited this scarcity in its use of food as a weapon and forced non-sustainable, resource-inefficient, capital and chemical-intensive agriculture on one of the most ancient agricultural civilisations in the world. American agricultural experts like Borlaug did not introduce the Green Revolution to "buy time" for India. They introduced it to sell chemicals to India ()".

The same "feed the world" arguments are being recycled by the promoters of genetic engineering today. In reality famine and hunger around the world have more to do with the absence of land reform, social inequality, biases against women in many cultures, lack of access to cheap credit and basic technologies, rather than a lack of agribusiness super seeds. It is also worth remembering that the Green Revolution has contributed to the "loss of three-quarters of the genetic diversity of major food crops and that the rate of erosion continues at close to 2 per cent per annum" (). No wonder the plant geneticist Garrison Wilkes accused plant breeders of building the roof with stones taken from the foundation ().

This was recognised by the participants who attended the World Food Summit which was held in Rome in November 1996. People are hungry because they do not have access to food production processes or the money to buy food. Those who wish to banish hunger should address those social and economic inequalities which create poverty and not pretend that a 'magic' technology will solve all the problems. Agribusiness companies will not distribute genetically engineered food free to the hungry poor who have no money. It is clear that the motivation for producing genetically engineered organisms is simply the desire by agribusiness corporations to make more profits.

The development of the 'terminator' gene, as it has been called, which can switch off a plant's ability to reproduce, points to the spurious nature of the 'feed the world' argument. Hope Shand, the research director with the Canadian RAFI group is alarmed at such a development. "Half the world's farmers are poor. They provide food for more than a billion people but they can't afford to buy seeds every growing season. Seed collection is vital for them" ().

By April 1998 Monsanto were admitting that they had misjudged consumer concerns over genetically engineered products in Europe. Philip Angell, its US director of corporate communications stated that "We made a mistake which we regret. We should have listened more carefully". Environment organisations believe that this remorse is not genuine. This pretence at listening and new found openness to dialogue with the opposition may well be simply another ploy to speedup acceptance of the genetically engineered products by consumers ().

Jeremy Rifkins contends that the US media has by and large accepted the warm 'glowing' arguments in favour of the biotech industry uncritically. It has trumpeted many of the breakthroughs on the "genetic frontier but has not taken the time to examine the more complex risks, pitfalls, and dangers that accompany the biotech revolution- issues that cry out for public airing as we turn the corner into the century of biology" ().

Given the difficulties associated with genetically engineered organisms VOICE feels that there is good reason to insist on a five year moratorium on the deliberate release of genetically engineered organisms until the risks are much more clearly understood and there is a thorough public discussion of all the issues involved.

At a seminar on biotechnology during the Biosafety Meeting in Montreal in May 1997 a delegate from West Africa asked: How old is the oldest transgenetic line? None of the scientists present could answer his question. Dr. Mae-Wan Ho points out that there is "no data documenting the stability of any trangenetic line in gene expression, or in structure and location of the insert in the genome". She goes on to stipulate that "such data must include the level of gene expression as well as the genetic map and DNA base sequence of the insert and its site of insertion in the host genome of each successive generation. No such data has ever been provided by the industry, nor requested by the regulatory authorities". Until such information is available at least over a five year period, it makes all kinds of sense to insist on a moratorium.

The Union of Concerned Scientists in Washington in their 1993 report on genetic engineering entitled "Perils Amidst the Promise" also promote the idea of a moratorium. They concluded that no company should be permitted to commercialise a transgenetic crop in the United States until a strong government programme is in place that assures risk assessment and control of all transgenetic crops, and gives adequate consideration to centres of crop diversity in the US and elsewhere in the world.

Austria has imposed a two year moratorium on field trials of genetically engineered organisms. One million, two hundred thousand people, representing 20 per cent of the population signed a petition supporting a ban on genetically engineered foods, as well as a moratorium on the deliberate release of genetically engineered organisms. Switzerland held a referendum on Genetic Engineering on June 7, 1998. After a bitterly fought campaign the voters decided to reject a proposal to ban the patenting and production of genetically altered plants and animals.

The request for caution seems eminently reasonable given the fact that the issues are so grave and the dangers of getting it wrong are too serious. As humans have learned from bitter experience, it is impossible to recall a living organism.

The story of the African Killer Bee ought to foster caution. A noted Brazilian geneticist, Warwick Kerr, was experimenting with the bees when it accidentally escaped into the wild. This happened in the late 1950s. The bee has now spread throughout South and Central America and is moving north in the United States with devastating results for the environment and people.

Such dramatic failures by scientists themselves should breed caution. Recombinant DNA techniques has delivered enormous power into the hands of a small group of people in the biotechnology corporations where profits often tend to take precedence over everything else. For this reason the public should make sure that a lot more is known about the safety of genetically engineered organisms before any group in society is allowed to begin to tinker, in an extensive and impactful way, with the building blocks of life. There should be a full-scale public debate on both the benefits and risks involved in genetic engineering based on comprehensive scientific knowledge and a full airing of the economic, social and ethical implications of biotechnology.

Ireland should follow the Norwegian model in deciding whether we adopt genetically engineered organisms or not.

In 1996 Norway adopted a consultation model on biotechnology which was developed by the Danish Board of Science. In the process groups of ordinary people assessed the various aspects of biotechnology. These include the ethical, economic, political, social and legal perspective, in addition to the narrower technological considerations. Only after hearing all the evidence was the group asked to decide whether Norway should opt for biotechnology or not. The panel concluded that "there was no need for genetically modified food in Norway today, because the selection, availability and quality of ordinary food is satisfactory. Too many uncertain factors are attached to genetic engineering" ().

We would do well to follow the example of Norway and begin a genuinely comprehensive debate. We at VOICE hope that the consultation process announced by the Minister will in fact be genuine and substantial. This means that a much more transparent and participative process will have to be designed. All the participants must have a role in structuring the debate. To date the process has followed adopted a top-down model and as a result the Consultation Paper is slanted in favour of the biotech industry.

In addition we argue that it is unacceptable and dishonest to call for a debate on whether Ireland should, or should not, opt for the technology while field trials are taking place and genetically engineered foods are being rush to the market. We believe that currently decisions about biotechnology are being taken primarily on commercial grounds only. While recognising the importance of the commercial factor, it should not be allowed to take precedent over everything else. Whether, for example, other creatures have rights that preclude humans tampering with their genetic code goes beyond whether the operation might generate hefty profits for the share-holders in some company. The same applies to the arguments about whether the technology is safe in terms of human health and the environment? These questions ought to be debated and a national consensus arrived at before the biotechnology juggernaut is cranked up and allowed to speed through the countryside effectively side-tracking and making any debate irrelevant. A close-the- door-after-the-horse-has-bolted approach is either a charade or a public relations exercise. Hopefully, the proposed consultation will have more substance than that, though we are naturally apprehensive given the involvement of well-funded public relations companies as described earlier.

It is also crucial that the David and Goliath disparity in terms of resources between small, poorly funded and staffed NGOs and the well-funded pro-biotech world of industry, academic institutions and government agencies be acknowledged. The former group is sceptical and is looking for a moratorium on deliberate releases and a comprehensive debate. The latter appears to be more interested, at this moment in time, in getting on with the business of testing and marketing products Unless resources are made available by the government the NGOs will not be able to afford the technical expertise which they require to marshal and disseminate their arguments in order that the public debate is well informed.

Finally we in VOICE are not, in principle, against genetic engineering. There may be very useful applications for the technology in agriculture and medicine. However we recognize that it is an new and exceptionally intrusive technology with the power to re-fashion the natural world and humanity itself. It is only prudent to take a long hard look at it and other alternative technologies before opting whether to accept or reject it. Future generations, who might have to live with the consequence of genetic engineering, deserve nothing less.