The Committee on Economic, Social and Cultural Rights considers that the core content of the right to adequate food implies:. The accessibility of such food in ways that are sustainable and that do not interfere with the enjoyment of other human rights. State obligations require active protection against other, more assertive or aggressive subjects -- more powerful economic interests, such as protection against fraud, against unethical behaviour in trade and contractual relations, against the marketing and dumping of hazardous or dangerous products. This protective function of the State is widely used and is the most important aspect of State obligations with regard to economic, social, and cultural rights, similar to the role of the State as protector of civil and political rights;".
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Other important human rights principles that could bear upon GMOs, although not included in the Universal Declaration of Human Rights, are the rights to informed choice and to democratic participation. The existence of GMOs raises the issue of the right to informed choice, which derives from the ethical concept of autonomy of individuals. This principle can be applied, for example, in the debate on labelling food derived from GMOs to ensure that consumers know what they are consuming and are able to make informed decisions.
Informed choice and resulting actions require access to information and resources. Consumers do not all have the same access to information and resources to make informed decisions about GMOs. Particularly in developing countries, the very poor both women and men may lack the most basic information to make decisions that may affect their health and capacity to sustain themselves. Appropriate methods to reach the least educated, the poorest and the most disadvantaged groups should form part of any strategy to inform the public so that individuals are able to choose according to their needs.
The right to democratic participation addresses the need for justice and equity, which are of major concern in the context of GMO-related decisions. Principles of justice may include gender equality, need, accountability, liability, and fair and democratic procedures. Many young people, particularly the poor and powerless, have little education and no social entry point to influence decisions about GMOs.
They need to be given every opportunity to participate in the debate concerning both the impact of GMOs on their lives and livelihoods and the potential benefits that may arise from the development and use of such products. They should also have the right to choose the product that best suits their needs. Of concern is the fact that future generations have no voice or vote in decisions taken on GMOs today, which means that ways must be found to ensure that their interests are taken into account.
Options must be kept open so as to enable future generations to meet their specific needs, including those deriving from unpredictable environmental changes. Food safety, the environment and GMOs are linked in the minds of consumers who, through their purchasing, will play a pivotal role in influencing decisions regarding the future of this technology. A number of consumers' concerns can be classified according to the following six issues:. Food safety. The foundation of consumers' concern about GMOs is food safety.
Because of experiences with non-GMO food problems such as allergens, pesticide residues, microbiological contaminants and, most recently, bovine spongiform encephalopathy "mad cow" disease and its human counterparts, consumers are sometimes wary of the safety of foods produced with new technologies. The approaches being taken by governments to ensure the safety of GMOs are discussed in the sections under Risk analysis, p. Environmental impact. The potential of GMOs to upset the balance of nature is another concern of the public.
GMOs are "novel" products which, when released, may cause ecosystems to adjust, perhaps in unintended ways. There is also concern about the possibility that genetic "pollution" will result from outcrossing with wild populations. As with non-GMOs, an issue is whether pre-release testing especially when limited to laboratories or computer models is an adequate safeguard for the environment or whether post-release monitoring is also necessary. The extent of post-release monitoring needed to protect ecosystems, especially with long-lived species such as forest trees, becomes an ethical as well as a technical issue.
The current understanding of the environmental impact of GMOs is reviewed in the relevant chapter, p.
GENETICALLY MODIFIED FOOD CROPS AND PUBLIC HEALTH
Perceived risks and benefits. In forming their views about GMOs, consumers weigh the perceived benefits of accepting a new technology against the perceived risks. Since practically none of the currently available or forthcoming plant and animal GMOs presents obvious benefits to consumers, they question why they should assume possible risks. It is said that consumers take the risks while the producers or the suppliers or companies reap the benefits. The science-based methods used to assess risks, together with their relationships with risk management and risk communication, are discussed in the chapter GMOs and human health, p.
Consumers have a legitimate interest in and right to information with regard to GMOs in agriculture. This begins with rules for the transparent sharing of relevant information and the communication of associated risks. Science-based risk analysis seeks to enable experts to make decisions that minimize the probability of hazards in the food supply system and the environment. Consumers, however, may also wish for more transparency to protect their right to exercise informed consent on their own.
An often-discussed set of means intended to protect these rights is the labelling of products, whether or not they are derived from GMOs. Informed consent and labelling are also discussed in the chapter GMOs and human health, p. Consumers may wish to be more involved in local, national and international debates and in policy guidance.
At present, there are very few fora available to the public to discuss the wide range of issues relating to GMOs. A shortage of fora can, understandably, lead to advocates concerned with one aspect of GMOs, such as environmental impact, pushing their concerns into a forum set up for another aspect, such as labelling.
A related issue is how to bring the private sector transparently into public fora and, subsequently, how to hold public and private sector agencies accountable. So far, the development of GMOs in agriculture has mainly been oriented towards cost-reduction at the farm level, primarily in developed countries. Societies have ethical standards that acknowledge the importance of ensuring that those who cannot satisfy their basic food needs receive adequate means to do so.
Ethical analysis can consider the moral responsibility of societies, communities and individuals to ensure that economic growth does not lead to an ever-widening gap between the poor majority and the wealthy few. When appropriately integrated with other technologies for the production of food, other agricultural products and services, GMOs may, among other biotechnologies, offer significant potential for assisting in meeting the human population's needs in the future.
An ethically salient issue that then emerges is how the development and use of GMOs in agriculture can be oriented towards improving the nutrition and health of economically poor consumers, especially in developing countries. The agricultural production and distribution system can be thought of as a supply chain see Figure : i goods flow from producers farmers through processors and retailers to reach the consumer; ii advertisers, activists, lobbyists and the media seek to influence choices made by people at each step of the supply chain; iii government regulatory bodies assess risks, set rules and monitor compliance; iv producers of food, fish, fibre and forest products purchase inputs such as seeds, planting materials, agrochemicals, fertilizers, feed, fermentation promoters and machinery; v GMOs reach the public through markets.
Consumers, in reality comprising everyone in the world and including future generations , also have a stake in the process. Source: Adapted from Economic impacts of genetically modified crops on the agrifood sector: a synthesis. The literature search for this working document ended 31 March, Consumers' choices in the market cannot be ignored: they are not forced to buy something if they choose not to.
If consumers decide not to buy a product, the associated production processes will simply wither away. Given the refusal of many consumers in certain countries to buy current GMOs, producers of GM crops are reconsidering their production decisions and the agrifood industry is rapidly restructuring, and even changing the thrust of its research and development efforts, to take this response into account.
The market is not the only place where consumers can express their views or preferences. They may wish to have a more direct "say" in how their food is produced. Increasingly, however, consumers throughout the world now live and work far from the points where their food is grown and processed, and this lack of direct involvement in the production process can result in their views on the agrifood system and its products being largely ignored.
Tools and techniques used by agricultural input suppliers Most of the intermediate products and methodologies that allow the development of GMOs, for example molecular fingerprinting and transformation technologies, are currently under intellectual property rights protection in the private sector. Consequently, public sector scientists, especially in developing countries, have less chance of obtaining access to such products and methodologies.
This limits their capacity to develop improved strains of crops or animals, including GMOs that could help overcome their particular local or national production constraints. The current situation therefore tends to widen the gap between richer and poorer societies. In recent years, an increasing number of products derived from GMOs have been developed and made available for public consumption.
A small selection of agricultural GMOs that are either on the market or under development are presented in Tables 1 and 2. GMOs that target insects with Bacillus thuringiensis toxins "Pest-protected" varieties were among the first GM crops to be developed, for the purpose of reducing production costs for farmers.
Insect-resistant GMOs have been promoted both as a way to kill certain pests and to reduce the application of conventional synthetic insecticides. For more than 50 years, formulations of the toxin-producing bacteria Bacillus thuringiensis Bt have been applied by spraying in the same way as conventional agricultural insecticides to kill leaf-feeding insects.
In the late s, scientists began to transfer the genes that produce the insect-killing toxins in Bt into crop plants. The intention was to ensure that the toxin was produced by all cells in these GMOs. At present, more than 5 million hectares are currently planted to Bt transgenic crop varieties. Although no efforts were made to increase the growth rates or yield potential of the GM crops with these innovations, farmers have welcomed Bt crops because of the promise of better insect control and reduced costs.
However, in the United States, the impact of Bt GMOs on crop yields and the number of conventional insecticide applications have varied widely by location and by year. This is partly because of differences between the intended potential impact of the GM crops on target pests and their actual field performance. Some of these differences were due to the uneven distribution of the toxin within the plants as they grew, some were due to variations in target and non-target pest populations, and others were the result of toxins accumulating in plant-feeding insect pests, causing mortality of predators and parasites that ate those pests.
As with varieties carrying conventionally bred host plant resistance, farmers should manage GM varieties within an ecologically based integrated pest and production management IPPM system so as to respond adaptively to environmental variation. In North America, the consensus is now that these varieties have lowered the costs of pest control. They are recommended together with host plant resistance management strategies to slow down the evolution rate of the pests that are able to feed on them.
GMOs for food processors and retailers Food processors and retailers are also keen to reduce their costs and reap the potential benefits of biotechnology. As the Box shows, GM tomatoes were designed to. GMOs for the benefit of intermediaries in the food supply chain: Flavr Savr tomatoes. The Flavr Savr brand of tomatoes was the first GM food product to be introduced in the fresh food market for public consumption. The tomatoes were genetically modified to delay ripening and they therefore had a prolonged shelf-life in the supply chain. Calgene, in the United States, released this brand of GM tomatoes in Since , Flavr Savr tomatoes have been taken off the fresh produce market in the United States.
The manipulation of the ripening gene appeared to have had unintended consequences such as soft skin, strange taste and compositional changes in the tomato. The product was also more expensive than non-modified tomatoes. Flavr Savr tomatoes are still used with success in processed tomato products. Their longer life allows more flexibility in shipping and storage between the field and processing plant. The case of the Flavr Savr tomato shows how retailers are sensitive to the opinion of consumers when they are close to them.
The concern about consumer confidence may outweigh the prospect of short-term benefits that a processor could gain from using ingredients derived from GMOs. If the public perceives GM foods to be unsafe or harmful to the environment and, therefore, rejects some products, companies may dissociate their products from GMOs. At the present time, some leading food companies have removed ingredients derived from GMOs from their products because they are wary of consumer rejection.
Changes in processors' and retailers' demand for ingredients derived from GMOs are carried back up the food supply chain to affect farmers' decisions about whether or not to grow GMOs. GM farm animals and fish have not entered the food supply chain Following some initial problems, there was considerable growth in the development and commercialization of GM crops, but products derived from GM farm animals have not reached substantial food production systems. Although more than 50 different transgenes have been inserted experimentally into farm animals, these efforts still require considerable skill and are not as routine as those for plants.
Early research in the development of transgenic farm animals has also been accompanied by manifestations of perturbed physiology, including impaired reproductive performance. These experiences raised ethical problems of animal welfare and further damped consumer interest. So far, the prospect of foods from transgenic farm animals has not been well received by consumers. Surveys consistently show that the public is more accepting of transgenic plants than of transgenic animals.
Experimenting with and altering animals is a less acceptable practice and has broader implications. Various cultures and religions restrict or prohibit the consumption of certain foods derived from animals. However, ingesting or being injected with certain pharmaceutical products from transgenic animals seems more acceptable to the public.
Highly successful research has been carried out on GM fish, but no GM fish have entered the market. Most GM fish are aquaculture species that have received genes governing the production of growth hormones, in order to raise their growth rate and yield. Ethical questions on the welfare and environmental impact of these GM fish have been raised, but it is also argued that GM fish share many attributes of conventionally selected alien fish species and genotypes, both of which are proven and accepted means of increasing production from the aquatic environment.
There is much confusion about the risks of GMOs in terms of food safety and environmental impact. Regulatory agencies formulate their standards according to science-based assessments of risk. Many consider that decision-making based on science is the only objective way to set policy in a world of diverse opinions, values and interests. Risk analysis is a process consisting of three components: risk assessment, risk management and risk communication. Risk in the context of safety includes two elements: i hazard, an intrinsic factor e.
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Thus, in relation to chemicals, risk is taken to be hazard x chance of exposure; in relation to quarantine, it is the potential damage by the pest x chance of introduction, etc. Risk assessment is a scientifically based process consisting of the following steps: i hazard identification; ii hazard characterization; iii exposure assessment; and iv risk characterization. Hazards, and the chance of those hazards occurring, are thereby studied and models constructed to predict the risk.
These predictions can be verified afterwards through, for example, statistical epidemiological studies. The two components of risk both contain a measure of uncertainty, and it is this measure of uncertainty that is the focus of many discussions. For example, there is some doubt as to whether risk estimation methodologies used for related purposes e. In particular, the hazard component of risk analysis is subject to close scrutiny. Risk management and alternatives analysis Risk management , 5 distinct from risk assessment, is the process of weighing policy alternatives in consultation with all interested parties, considering risk assessment and other factors relevant for the protection of consumers' health and for the promotion of fair trade practices as well as, if necessary, selecting appropriate prevention and control options.
Environmental hazard is probably less easy to quantify than health hazard. It also refers to a common good instead of a private health good. In both instances, only long-term experience can show if risk assessment and risk management have been successful. When a sound risk management strategy is applied to environmental problems, as distinct from safety problems, it will begin by describing a problem and the goals, objectives and values to be pursued by solving that problem.
An analysis of alternatives is then carried out to consider as many solutions as possible. Rather than narrowing the analysis, this allows the creation of new options or combinations of options. When the benefits and drawbacks of a wider range of solution scenarios can be compared, fuller participation by the concerned society can be better assured. Risk communication Risk communication is the interactive exchange of information and opinions among assessors, risk managers, consumers, industry, the academic community and other interested parties throughout the risk analysis process.
The information exchange concerns risk-related factors and risk perceptions, including the explanation of risk assessment findings and the basis of risk management decisions. It is vitally important that risk communication with the public comes from credible and trusted sources. Foods are complex mixtures of compounds characterized by a wide variation in composition and nutritional value.
Although priorities vary, food safety is a concern among consumers in all countries. They would like assurances that GM products reaching the market have been adequately tested and that these products are being monitored to ensure safety and to identify problems as soon as they emerge. Because of the complexity of food products, research on the safety of GM foods is still thought to be more difficult to carry out than studies on components such as pesticides, pharmaceuticals, industrial chemicals and food additives.
Through the Codex Alimentarius Commission and other fora, countries discuss standards for GMOs and ways to ensure their safety. One approach, which is being used in assessing the risks of GMOs, derives from the concept of substantial equivalence.
Substantial equivalence acknowledges that the goal of the assessment is not to establish absolute safety but to consider whether the GM food is as safe as its traditional counterpart, where such a counterpart exists. It is generally agreed that such an assessment requires an integrated and stepwise, case-by-case approach. Factors taken into account when comparing a GM food with its conventional counterpart include:.
If the GMO-derived food is judged to be substantially equivalent to its conventional counterpart, then it is considered to be as safe as the counterpart. If it is not, further tests are conducted. The differences between the United States' and the European Union's perspectives on the labelling of GMOs illustrate some of the issues in the debate.
In the United States, the law requires information on food products to be clear and unambiguous. Labels are intended to provide meaningful information and to warn and instruct the consumer. Further misleading or unnecessary information is believed to conflict with the right of consumers to be able to choose wisely, and to lessen the effectiveness of essential label information. If GMOs are not different from their traditional counterparts in terms of nutrition, composition or safety, labelling is considered to be unnecessary and perhaps misleading.
In the European Union, labelling is viewed as a way to ensure the consumers' right to know any fact that they deem important; it is a way to give consumers a choice and to inform them about GMOs. The European Union's approach to labelling attempts to reach a compromise among the industrial, scientific and public sectors. In the European Union, the question is not whether to label products of biotechnology, but how to label them.
Labelling of GM Products. Consumers have a right to be informed about the products they buy. However, whether or not the labelling of GM foods is the most appropriate and feasible way to enable consumers to make informed choices about such food products is the subject of an active and ongoing debate in number of countries. It is also being debated by the Codex Alimentarius Commission. A number of governments have adopted labelling policies and procedures for GMOs, which vary substantially.
Farm-to-consumer labelling protocols may pose insurmountable challenges for countries of limited capacity wishing to earn income in international markets. Genetic modification offers the opportunity to decrease or eliminate the protein allergens that occur naturally in specific foods. With the objective of assuring food safety, greater attention has been given to the potential risks of genetic modifications that may add allergens to the food supply. All products that contain allergens, irrespective of their origin, should be managed similarly -- for example by labelling -- to ensure the consumers' right to informed choice and the possibility to avoid allergens in foods.
The Brazil nut-soybean see Box provides an example of how a potential health problem was avoided by testing before marketing. The possibility of transferring allergens with genetic engineering came to light when a methionine-producing gene from the Brazil nut was incorporated into soybean to enhance its nutrient content. The process was experimented by Pioneer Hi-bred in the United States.
The tests conducted by their scientists on allergens, however, confirmed that consumption of the transgenic soybean could trigger an allergic response in sensitive subjects. The nature of the allergic reactions was the same as those triggered by Brazil nuts in sensitive subjects. The company, therefore, decided not to release the transgenic soybean for sale. This particular case was significant in raising awareness about the potential dangers associated with the transfer of genes in the absence of a better understanding of their functional characteristics.
The recent announcement that GM crop varieties can be made to produce the precursor of vitamin A see Box on golden rice generated considerable anticipation that products from these crops could contribute to solving the serious public health problem of vitamin A deficiency. This anticipation expanded the public debate on the role of GMOs as part of strategies to address global nutrition problems. Scientists are also experimenting with genetic engineering techniques to prevent food safety problems.
For example, genetically modified Bt maize, which is resistant to attacks from toxin-producing fungi, has been associated with decreased mycotoxin contamination. Mycotoxins are carcinogens and they can lead to liver cancer in humans. The fact that fewer feeding punctures from insects are found on Bt maize is thought to mean that there are fewer openings for fungal infection.
Recently, rice was genetically engineered by the insertion of three genes from daffodil and bacteria that generate enzymes that make the rice grains produce beta-carotene, which can be converted into vitamin A in the body. This transgenic rice produces golden-coloured grains containing enough beta-carotene to meet a person's daily requirement of vitamin A. The potential to create rice with an enhanced micronutrient content illustrates one way in which genetic engineering can contribute to reducing malnutrition.
Vitamin A deficiency, which is widespread in the developing world, can lead to morbidity and blindness and contribute to child mortality. There are a number of alternative ways to address the problem of vitamin A deficiency, for example promotion of foods that are naturally rich in vitamin A, supplementation and fortification. These technologies are already being used and, although experts debate the merits of each approach, they are found to be effective in treating the illness.
However, other methods are becoming available. It has a relatively high rate of success, is technically simple to carry out, has potential for transferring larger pieces of DNA and is applicable to animals. For the development of improved food materials, GM has the following advantages over traditional selective breeding:.
Genetically Modified Crops and Food Security
These advantages in turn lead to a number of potential benefits, especially in the longer-term, for the consumer, industry, agriculture and the environment:. There are those who allege that "scientists claim that GM will solve the problem of world hunger". This is a familiar "straw man". It is frequently argued by some that there is more than enough food to feed the world and all that is needed is "fairer distribution" which so far mankind has signally failed to achieve — or a variant of that, "the real problem is not shortage of food, it is poverty".
Whatever may be done by way of improved yields through conventional methods, attempted population control and more effective distribution would, however, be inadequate for the future. There are probably enough cereals to feed the present world population if only they could be distributed to the right places at the right times and could be afforded. But there will be substantial shortfalls in cereals in the next two decades, especially if the present practice of diverting cereals from human food use to feedstock for ethanol biofuel production continues.
Moreover, "world hunger" is a complex not only of inadequate quantity where it is needed but of inadequate quality i. However, in decades to come, with the expected substantial increase in the world population, mostly in the poorest, least developed countries, the demand for increased agricultural land and for water will greatly increase. The important point is not only how to feed the world now but addressing and trying to solve the problem of "How shall mankind feed the world in a few decades from now?
Food scientists and technologists can support the responsible introduction of GM techniques provided that issues of product safety, environmental concerns, ethics and information are satisfactorily addressed. The "first generation" of GM food materials were those that were relatively easy to develop, chosen for their likelihood of rapid commercial success by providing traits that would commend themselves to farmers.
The first food plants to be grown successfully on a large commercial scale and put on the market were the GM maize resistant to the European corn-borer, a serious agricultural pest, and the soyabean genetically-modified to be tolerant of the herbicide glyphosate. The latter involves one or two applications of a less toxic, more rapidly broken down herbicide than the spraying regime that it replaces, that of several applications of different herbicides. Contrary to the widely held misconception, glyphosate is not a relatively new herbicide developed for GM crops.
On the contrary it has been in use for over 40 years and has been a very popular broad-spectrum, safer and less soil-persistent herbicide, for many conventional crops. But it could not be used for soya because it killed the soya as well as the weeds. So soya farmers had to continue to use a "cocktail" of different herbicides at different stages of the growing season. The clever scientific trick was so to genetically modify soya that it was not killed by, but resistant to, glyphosate. However, these GM products did not offer consumers a readily perceivable benefit "at the point of purchase"; and with intensified campaigns and media amplification in the early part of and thereafter highlighting problems and uncertainties some real, some pure speculation, some spin-doctored and some urban myths , the UK public became turned against GM.
Reacting to their customers' views, major retailers and manufacturers decided to exclude GM foods and ingredients. An incidental victim was the canned tomato puree, prominently labelled "Produced from genetically modified tomatoes", on sale in stores of two major UK supermarket groups in competition with non-GM tomato puree. The GM tomato puree was of better flavour and consistency, cheaper, and consistently outsold the non-GM puree. It is now no longer available. Chymosin, produced by GM micro-organisms, was developed to replace rennet, the milk-clotting enzyme used extensively in cheese-making, due to the severe shortage of the traditional source of the enzyme i.
The GM enzyme, defined as a processing aid rather than a food additive in regulatory terms, has been in use since the late s in the USA and in some European countries, including the UK. Increasingly at the heart of the "concerns" debate about GM, is the fundamental matter of the role of science and society in relation to "new" science-based developments such as GM.
There are two ways of dealing with new developments with associated problems and uncertainties. One is to reject or ban the developments. The other is to address and solve the problems, and to accept that there are no certainties in any aspect of life. Fortunately in the long run mankind has generally adopted the second course, otherwise we would still be living in the Stone Age. Looking at more recent times, there would be no electricity; the first passenger flight would not have taken place, so there would be no air travel; the first surgical operation would never have been carried out so there would be no surgery; the first anaesthesia would never have been used, so there would be no anaesthetics it is worth recalling that the medical profession of the day prevented Queen Victoria from having anaesthesia with the difficult births of her first seven children "not natural, not proven safe, not sufficiently tested, what about the long term effects?
Exactly the same arguments were used in the early decades of the 20th century to try to prevent the legalisation of milk pasteurisation. Fortunately it was eventually legalised and over the last nine decades has saved untold numbers of lives that would otherwise have continued to be lost to milk-borne tuberculosis -- second only to clean water as the most important public health measure ever adopted.
Science depends on gaining knowledge, organising it into a coherent structure, hence improving understanding, and applying it. It is society's tool and method for doing so. However, we can never know everything there is to know about a topic. The one certain thing about life is that nothing in life is certain. In real life, decision and action by society to meet its needs has to be based, not on certainty but on using the best knowledge available at the time, and on skilful selection of areas for urgently needed research.
In the absence of certainty it has to involve the combination of risk analysis and the precautionary principle, which are two inseparable sides of the same coin. These lie at the very crux of any discussion on the application of GM. The relationship involving these three activities is not a linear one but one of dynamic and ongoing interplay. A precautionary approach is a concept familiar to, and used by, food scientists and technologists.
Taking precautions in advance to identify foreseeable hazards and adopting measures to prevent harm from occurring is at the heart of the Hazard Analysis Critical Control Point HACCP preventive food safety system. The precautionary principle is particularly relevant to the management of risk. The precautionary principle, which is essentially used by decision-makers in the management of risk, should not be confused with the element of caution that scientists apply in their assessment of scientific data.
Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty. The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty.
Anti-GM activist groups have focused wholly on the phrases "…. This fails to recognise that science can never produce conclusive results and cannot deal in certainty. Moreover, experience teaches that the situation envisaged is most likely to arise in areas such as biotechnology where there are strong ideological agendas, in pursuit of which some individuals, including, unfortunately, some scientists, present unsubstantiated speculation, assumptions and guesswork as though they were "preliminary objective scientific evaluation".
This sometimes takes the form of published purported "research papers" which on scrutiny turn out to be merely the authors' speculations and opinions, complete with references to similar papers by like-minded individuals. If that sort of presentation is considered enough to bring a development to a halt, and, as we have seen, scientific evidence is always insufficient and science cannot prove anything to be safe, it can then be argued in perpetuity both by its ideological opponents and by scientists who see further research as a funding opportunity, that the development should not be implemented "until we know more".
Purported "preliminary objective scientific evaluation" should, therefore, always be very carefully and rigorously scrutinised to ensure that there is a broad scientific consensus that it is based on some hard scientific evidence. Moreover, what is frequently overlooked and always overlooked by the opponents of a development is that PP should be applied not only to that development but to all alternative courses of action, including that of doing nothing.
Why does EFSA not carry out its own studies? Can the public access GMO applications? How does EFSA take account of long-term effects for human health and the environment and assess potential impact on biodiversity? What about the issue of coexistence with conventional crops and uncertainties, assumptions and the precautionary principle? Why does EFSA keep getting asked to look again at its risk assessments?
It is an oft-repeated environmental truism that we hold the world in trust for future generations. It would be a betrayal of that trust and an abdication of responsibility by the present generation if science were to limit itself to collecting and providing information about current biotechnology applications, or if society were to limit itself to arriving at verdicts about them.
We society and scientists as part of society must not behave as disinterested spectators standing on the sidelines and observing problems that may stand in the way of providing future generations with the potential benefits that GM can offer. We have a duty to address and solve such problems. Thus, the real questions to be answered are not "Is it safe? Is it environmentally friendly? What do we have to do to make it environmentally friendly? These questions and answers have been prepared by WHO in response to questions and concerns by a number of WHO Member State Governments with regard to the nature and safety of genetically modified food.
When introducing any new technology, including gene technology, into the food chain, there is a need to adopt appropriate safeguards to protect human health. Most countries in the Western hemisphere started developing regulatory controls well before any GM foods reached the market. These controls were put in place not because safety problems had been identified but because of a lack of familiarity with GMOs. Although many of the early concerns regarding the safety of GM foods have not materialised, the precautionary approach has continued as it remains important to ensure that no new hazards are created.
When considering safety in relation to GM, generalisations cannot validly be made. Instances have to be considered and studied in a case-by-case approach, and each case should be assessed in relation to the food involved, as ready for consumption, whether by man or by animals. Regulations in most countries, including the UK, include the concept of substantial equivalence. The concept is based on the idea that existing organisms used as food or food sources can serve as a basis for comparison when assessing the safety for humans of modified foods or ingredients.
If a new food or component is considered to be substantially equivalent to an existing food or component the theory is that it can be treated in the same manner with respect to its safety and nutritional assessments. Acceptability or non-acceptability is established by determining whether a novel food is substantially equivalent to an analogous conventional food in terms of composition, nutritional properties, toxin and allergen content, the amount consumed, the type of processing industrial or domestic that the food might undergo and consumption by vulnerable groups of people e.
Foods are assigned to three categories:. Where differences are identified, extensive animal feeding and toxicological trials are required. The establishment of substantial equivalence is an analytical exercise which has to be approached carefully. The comparison may be a simple task, or very lengthy, depending upon the nature and experience with the foods or components being compared.
It must also contain a dynamic element to take into account that the continuing modification of a food will require that the most recent novel food is compared with an appropriate former novel food and not necessarily with the original and traditional counterpart. An understanding of substantial equivalence is key to understanding the basis of GM regulatory controls.
However, when developing any novel foods, including GM foods, care must be taken that allergenicity is not inadvertently introduced into the diet. This requires assessment of the allergenicity of a new protein by predictive methods, experimental testing and a post-marketing surveillance based on traceability. The testing of GM products for suspected allergens can be done by an IgE test with serum from sensitive individuals [e. Herian et al ]. However, there is also a need to test products where genes have been inserted from sources not known to be allergenic.
Astwood et al have developed a method. Stability of a protein or protein fragments to digestion in simulated gastric fluid SGF may be used to assess the potential allergenicity of a protein. The British Medical Association BMA in its earlier "interim statement" on GM had been hostile to GM and called for an open-ended moratorium on all commercial planting of GM crops until more was known about their effects on human health. Indeed that had been one of the factors influencing the visiting party of Zambian scientists to return to Zambia with recommendations against GM.
Famine still threatens 2. New Scientist, 29 January In accordance with our intention to keep the public informed, we held a round table meeting of experts in June and have recently reviewed the emerging evidence. In producing an update of our report, the BMA seeks to support balanced debate. As an organisation of doctors, we are not experts in agricultural techniques and crop science, but we are concerned with all issues of public health. The environment in which we live, the air we breathe, the water we drink and the food we eat, all have an impact on our health as individuals.
It is this context that the statement has been prepared. However, we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit. Numerous perceived concerns regarding the safety of GM foods have been aired, many of them speculative and without any scientific evidence, but three substantial concerns which have been most widely discussed are in fact urban myths. These are the L-tryptophan story, the brazil nut allergen story and the events surrounding Arpad Pusztai and his potato experiment. A frequently repeated account alleges GM as the cause of the disease that caused illnesses and 37 deaths in USA in The story refers to the so-called Eosinophilia-Myalgia Syndrome EMS syndrome associated with some dietary supplements containing the amino acid L-tryptophan.
The illnesses and death did occur, but the rest of the story is untrue. In reality, extensive investigation traced the cause to an impurity in L-tryptophan made by just one of its several chemical manufacturers, all in Japan. There has been successful litigation by three plaintiffs against SD KK. The GM issue was not raised seriously by the plaintiffs because there was such overwhelming evidence against it being a factor. The manufacture of L-tryptophan is by a fermentation which also results in the formation of a number of secondary substances.
To produce L-tryptophan of a purity necessary for human ingestion, the fermentation product mixture has to go through purification processes to remove the impurities, by-products and cellular debris, including treatment with activated carbon and reverse osmosis. Investigation of the records of Showa Denko KK showed that in the critical period December to June they made a number of simultaneous changes to the manufacturing protocols. But this was accompanied by the partial bypassing of the reverse osmosis purification procedure, and a halving of the amount of activated carbon used both stupid and irresponsible things to have done , thus failing to carry out the purification effectively.
Subsequent research showed that in consequence the procedure left behind some sixty impurities; and also found significant correlation between the development of EMS and the reduction of the activated charcoal. There have been several attempts to explain the precise mechanism by which the syndrome occurred. One involves a residual impurity 1,1 '- ethylidenebis-[tryptophan] EBT , which then broke down to give 1-methyl-l,2,3,4-tetrahydro-beta-carbolinecarboxylic acid MTCA , a substance that was thought to have been involved in the EMS syndrome.
Another suggests that it was the result of a reaction between two or more impurities. Like so many food poisoning outbreaks investigated after the event, the exact mechanism is unlikely now to be conclusively proved, but it was nothing to do with GM. Thus the "tryptophan" story was not a consequence of GM, nor of tryptophan itself, but an impurity or impurities left in as a result of irresponsible short-cutting by a particular chemical manufacturer. With the currently much greater recognition of food allergens as a food safety issue, the possible introduction of allergenicity by genetic modification is a concern; and the apocryphal story of "people made sick by a brazil nut gene transferred into soya" has become a widely believed urban myth.
In fact, such a product never came on the market, and nobody ever ate any such product. Soya protein is deficient in methionine, and a seed company, Pioneer Hi-Bred, wanted to investigate the possibility of producing a soyabean with increased methionine content thereby improving the nutritional quality of soya protein , by transferring a brazil nut gene to soya. With any research involving any gene transfer, it is routine standard procedure to investigate whether any allergenicity could be thereby transferred.
In this instance, many people are allergic some very seriously so to soya itself; but it was important to investigate whether such a transfer would make the resulting soya allergenic also to people who are allergic to brazil nuts. The research was carried out at the University of Nebraska, the leading centre for allergenicity research. Perhaps not surprisingly, the researchers found that brazil nut allergenicity was transferred to the experimental material.
Pioneer Hi-Bred announced that the research project was discontinued, and the results were published in a peer-reviewed journal [Nordlee et al, ]. This has received considerable publicity. It relates to the purported adverse effects on rats of GM potatoes in which lectins had been inserted, and the associated TV programme and media interviews given by Dr Pusztai. Lectins, which are complex plant proteins, appear to act as pest deterrents in plants and lectin insertion into a crop plant by GM has been investigated as a means of enhancing pest resistance.
The story has been greatly confused by contradictory reports as to exactly what happened, and as to the supposed ill-treatment of the researcher concerned — mostly culled from the media and claims by Pusztai himself and activists keen to exploit the situation. Fortunately there is now a first-hand history available. The written statement submitted by the RRI, which, incidentally, is considerably sympathetic to Pusztai, gives a first-hand historical account and, incidentally, disposes of the various myths that have been put around about Pusztai and his treatment.
All have found the experiment flawed, poorly designed, and incapable of leading to meaningful conclusions. It was part of a larger programme designed to identify possible candidate genes, and their implications, for possible future use in the genetic modification of crops to enhance the crops' resistance to pests. Whilst investigations into this case have shown that the problems were not directly related to the genetic modification as originally claimed and still perpetuated by some they emphasise that a greater awareness of the possible areas of concern is needed when assessing the safety of GM foods.
Reporters given pre-embargo access had to sign an agreement that they would not speak to any outside experts before the embargo was lifted. The contract was essentially an abuse of the media, and of the embargo system, to quash early criticism. EFSA was requested by the European Commission to review this publication and to identify whether clarifications are needed from the authors. Similarly, the German Federal Institute for Risk Assessment BfR evaluated the study in terms of its relevance for the evaluation of the health risk of genetically modified glyphosate-tolerant maize NK and also with regard to the evaluation of the health risk of the glyphosate-containing formulation.
Therefore, the main conclusions of the authors were not supported by the presented data. The study did not comply with internationally recognised standards for long-term carcinogenicity studies. The rat strain used shows a relatively high spontaneous tumour rate, especially for mammary and pituitary tumours, and the number of animals used was too small and insufficient for assess-ing the claimed differences between the test groups and the control group.
Furthermore, the BfR criticises that the glyphosate dose administered was not determined in the studies with the glyphosate-containing plant protection product Roundup. Public funding should be made available for these studies Clearly, regulations will need continuous revision and updating as new data become available. In the UK, at present there are no GM crops being commercially grown. An experimental release, such as a field trial of a food crop, requires consent from the Government.
Applications for consent must include a considerable volume of data and a detailed assessment of the risk of harm to human health and the environment. If a risk is identified or there is some uncertainty about the level of risk, the applicant may propose measures to manage or eliminate the risk. The applications are scrutinised by the Advisory Committee on Releases into the Environment ACRE , a group of independent experts who advise the Government on whether consent should be given and whether extra conditions should be imposed prior to giving consent.
All releases are advertised locally and details are made available via a Public Register. Release sites are subject to inspection by the Health and Safety Inspectorate and those making the release are required to report any incidents that may occur during and after the completion of the trials. On the one hand this openness and transparency is admirable, but on the other hand the information made available has been seized on by organised extremists who invade and destroy the trials. Since , more than 25, field trials of GM plants have been carried out in 45 countries without adverse environmental consequences.
Furthermore, the rate of field-testing has increased rapidly especially in the USA where the number of trials has doubled each year since In terms of field releases, the European Union lags well behind North America. These trials represent considerable accumulated evidence in support of a favourable safety and environmental record for the new gene technology. The relevance of environmental data obtained from small field trials to large-scale sowing on several million acres of land has been questioned. A record This year, , was the 18th year of commercialization, , when growth continued after a remarkable 17 consecutive years of increases; notably 12 of the 17 years were double-digit growth rates.
The global hectarage of biotech crops have increased more than fold from 1. This adoption rate speaks for itself in terms of its resilience and the benefits it delivers to farmers and consumers. The report is entirely funded by the Rockefeller Foundation, a U. Past experience with introductions of new species to environments where they are not naturally present has shown that potential problems may take several generations to manifest themselves.
Possible cross-pollination from GM crops to non-GM crops is of concern to organic farmers, who fear that, if it occurs, their produce could no longer be said to be "organic", and to those who wish to have the right to choose non-GM foods. Three reports of trials in USA, Germany and Spain respectively have demonstrated effective co-existence. Farmers have a legitimate interest in growing their preferred crops conventional, organic or GM , and a coexistence regime must be fair and reasonable to all parties. This implies that there should be no additional discrimination against farmers growing GM crops.
Thus, issues concerning possible crosspollination or other interactions in all cases should be reciprocal. Following this principle IFST commented on four points:. There is also concern that traits such as herbicide resistance may spread to wild "relative" weeds at present the only GM crops that have wild "relatives" are canola and squash and that the problem of insect resistance may be aggravated. It has been suggested that the adoption of insect-resistant crops by farmers worldwide may lead to the extinction of certain insect species e. Lepidoptera thereby reducing the biodiversity of the planet.
Environmental regulation is difficult to enforce when there are no clear standards against which the performance of a product can be measured e. Concern has been expressed about the potential risk of GM crops hybridizing i. This has certainly happened with conventional crops but there is no evidence of it having occurred with GM crops. Ellstrand Nature Book Review , - ; Jan. Despite his effort to provide this broad context for hybridization between crops and wild plants, and its consequences, I suspect that most readers will focus on chapter 7, where Ellstrand contrasts his views with an opening quote from the Israeli plant scientist Jonny Gressel: "Most crops have no interbreeding relatives in most of the world.
I suspect that this table will be the most widely referenced in the book, and wish that a few of the distributions were more precisely stated. For example, cotton, beans and potatoes are listed with a "multicontinental" distribution of hybridization; more precisely this refers to Latin America and, for cotton, some islands in the Caribbean and Pacific.
But what about Gressel's proposition, especially in the context of GM crops? Many of the other crops are complicated to tabulate, but Gressel seems to be correct that most crops are not interbreeding locally with wild relatives. This still leaves the possibility that serious problems could arise in the few areas of the world where hybridization can occur.
This currently seems possible for GM canola in Canada and the United States, and for transgenic maize that is probably growing illegally in Mexico but has apparently escaped documentation in the refereed literature. But even after reading this book, I haven't seen any evidence of harm to human health or to the environment including weediness from such hybridization. Where are the super-weeds that were predicted to occur from the exchange of transgenes with wild relatives?
In contrast to the lack of evidence for deleterious effects of gene flow from GM crops, there is evidence that conventional agriculture has adversely affected wild plants through genetic swamping of their populations, and that wild plants have generated weediness in crop--weed hybrids. As noted by Ellstrand, "problems associated with hybridization between conventional crops and their wild relatives received scant attention until potential gene-flow problems were described for transgenic crops". For example, hybridization with cultivated rice has been implicated in the near-extinction of an endemic Taiwanese wild rice.
Hybridization of maize with its ancestor teosinte may be contributing to the extinction of teosinte populations. Indigenous cotton in the Galapagos Islands could be at risk of extinction or replacement as a result of hybridization with cultivated cotton. Ellstrand cites similar evidence for at least another nine species. He also documents in great detail the history of sugar beets in Europe, where hybrids between cultivated beets and their progenitors, the sea beets, have caused major weed problems.
However, the problem of gene flow, whether from GM to non-GM or vive versa or from hybridization of conventional crops with wild relatives may well be solved by -- genetic modification! Genetically engineered plants pose several major environmental concerns, according to Henry Daniell, a professor of molecular biology and microbiology at the University of Central Florida. When foreign genes are introduced into the nuclear genome, they end up in pollen, posing the risk of transfer to other species.
And sometimes, expression levels are low. Daniell and colleagues have come up with what he says is a solution: chloroplast genetic engineering. The method--the recipient of several patents, most recently US 6,,offers two benefits, says Daniell. First, like mitochondria, chloroplast genes are maternal and therefore not passed through pollen.
And because each cell has 10, copies of the chloroplast genome, expression levels are generally high. The transgene construct is designed to minimize disruption of the chloroplast genome. The gene to be inserted is put under the control of chloroplast regulatory signals so that errant transgenes won't express in the nucleus, Daniell says. Those that do hit their mark in the chloroplasts integrate via homologous recombination into a non-coding spacer region, where, Daniell says, "they won't disrupt anything else.
Gene delivery is achieved via a biolisitic gene gun. From there, it's typical transgenic manipulation--selection of cells that have modified chloroplasts, followed by testing the construct's maternal inheritance. Daniell has founded a company, Chlorogen, to license the method. In the UK, English Nature which at the time was the Government's statutory adviser on wildlife and natural features monitored developments which may affect wildlife and advised on how any damaging effects might be avoided. In , four genetically modified crops had cleared most of the regulatory hurdles before commercial growing could be allowed in the UK.
While these crops had been assessed as safe in terms of human health and direct impacts upon the environment, there had been insufficient research to determine whether there might be any significant effects on farmland wildlife resulting from the way that the crops would be managed. The results of three FSEs were issued on 16 October The presentations, by the authors, of the eight rigorously peer-reviewed research papers on the three spring-sown FSEs, between them constituting a huge, rigorously designed, rigorously conducted, epoch-making GM research project costing nearly six million pounds sterling.
In their presentations the authors were at pains to point out that their findings did not relate to the fact that the GM herbicide tolerant GMHT crops were GM, but to the differing herbicides and herbicide management systems that accompanied the GM crops and the conventional crop controls respectively.
The eight research papers present the FSE findings for those spring sown crops namely beet, maize and spring oilseed rape — the FSE trials results of winter-sown oilseed rape were not published until May The researchers analysed the effect of each crop and accompanying herbicide and herbicide management system on the plants and animals living in the vicinity. About 60 fields in different parts of the UK where these crops were normally grown, each were sown with beet, maize and spring oilseed rape. Each field was split, one half being sown with a conventional variety managed according to the farmer's normal practice, the other half being sown with a GMHT variety, with weeds controlled by a broad-spectrum herbicide glufosinate-ammonium in maize and spring oilseed rape, and glyphosate in beet.
There was stringent auditing of the farmers' adherence to the protocols. Comparisons in biodiversity were made by looking at the levels of weeds and invertebrates, such as beetles, butterflies and bees, in both the fields and the field margins immediately surrounding them. The results revealed significant differences in the effect on biodiversity when managing GMHT crops as compared to conventional varieties.
Predictably, activists of one sort or another, and the media, have been interpreting the results to fit in with their respective preconceived positions. For the scientist, the outcomes point to the importance of weeds and of soil seed-banks in sustaining farmland wild life. It has been axiomatic that with the present generation of GMHT crops the purpose was to get rid of weeds as thoroughly and effectively as possible with the minimum of labour and tillage and with minimum application in quantity and frequency of a relatively environmentally-friendly broad-spectrum herbicide.
Purely from a farmland wild live aspect, it could be argued that in two of the three crops beet and spring oilseed rape the herbicides performed their function too well. These results seem to suggest that there is a case for organizing the provision of sufficient weeds to maintain the farmland wild life. Put another way, a rational society wishing to take advantage of the agricultural benefits that each of these GMHT crop systems can provide would recognize the need for a trade-off, to establish for each crop and herbicide management system a point of equilibrium where the benefits can accrue alongside the sustaining of the farmland "natural communities".
Whilst the findings cannot answer all the questions resulting from the intense public interest and debate on the future of genetic modification in agriculture in the UK, they do provide a valuable model for the assessment of technological change. The FSEs also demonstrate that it is possible to design experiments at an adequate scale to help forecast the potential environmental impacts of new technologies and practices in agriculture - something that has never been done before.
The Committee noted that in the cases of beet and spring-sown oilseed rape FSEs, evidence showed that insect species and weeds declined in the trial areas, endangering birds that fed on them. However, it supported the growing of GM maize, saying it was better for the environment than conventional farming. It also suggested the other crops might be grown in future if measures were taken to protect wildlife. Although the UK Government subsequently approved in principle the growing of the GM maize for animal feed, the approval was heavily hedged around with onerous conditions including a four years repeat of the FSE trial but with a non-atrazine control.
The company concerned Bayer CropScience regarded it as totally impracticable and "economically non-viable" and withdrew. On 1 July it was announced that Syngenta, the last big biotechnology company working on GM crops in Britain, was to close its research facility in the UK and transfer its efforts to the United States. These comprehensive studies present the findings of research into the global socio-economic and environmental impact of GM crops in the eleven years since they were first commercially planted on a significant area.
Much of the vocal antagonism to GM expressed by its opponents appears to consist of ideological antipathy to large companies engaged in GM and to the socio-economic system which allows large companies to exist and thrive. This is, however, not specific to GM, for similar antipathy by the same groups is expressed about large companies engaged in other products and activities. A great deal has been said and written to the effect that the existence of GM seeds somehow denies the farmer the ability to practice in the traditional way -- as though farmers cannot choose whether to use GM seed or stick with non-GM.
One manifestation of this concern has been about the potential for misuse of the so-called terminator genes which prevent seeds from germinating. Although patents exist for terminator technology, it is not available commercially. There are fears that large corporations might use such genes in all their GM crops to prevent farmers from storing seed and that plants that produce barren seed could make life more difficult for poor farmers in the developing world.
However, farmers would only buy these seeds if they found an overall advantage in doing so; otherwise they could continue to grow conventional cultivars and save the seed in the traditional way. Furthermore, some fear that if cross-pollination occurs, GM plants with terminator genes could transfer their sterility to other plants grown nearby. However, on the positive side, terminator technology could ensure that GM plants do not themselves become weeds. Concerns have been expressed over the supposed problem of patents held by biotechnology companies preventing the use of beneficial GM crops in developing countries.
Here the research has involved the use of over 70 patents owned by biotechnology companies from whom they had to obtain permission before they could begin testing the golden rice in field trials. What the critics fail to mention, however, is that those patent holders granted Potrykus and Beyer exemptions for Golden Rice; and moreover have agreed to provide free licences for use by poor farmers in developing countries. At the 12th World Congress of Food Science and Technology in Chicago in July , Potrykus stated, in the course of a comprehensive presentation, that obtaining those nutrient-enhanced crops have not yet begun to help resource-poor farmers is not patents but "regulatory obstacles based on undue paranoia.
His World Congress presentation is not available on-line, but here is the full text of the paper he gave in April along similar lines. A wider matter, however, involves the general question of patents in relation to GM, and, more particularly whether genes can or should be patentable. By analogy with computer language, the procedure of inserting a gene into an organism is not just "cut-and-paste" but "cut- copy billions of times over -and-paste".
The laboratory-generated copies by that procedure are in every way exact copies of the copied original, but are not the original. Precise details of patent law vary from country to country, but in principle, patents are intended to protect inventions and give the inventor monopoly for a limited time to benefit from the invention. Whether it is the original gene or DNA fragment, or a lab-generated exact copy, these are not "inventions" and ought not to be patentable.
A gene is a pre-existing thing, and identification of a gene and its function is a "discovery" rather than an "invention". However, an invention is often a novel combination of pre-existing things, and it is not those things but the combination of them which may be accepted as an invention and therefore patentable. Generally, patent law requires novelty and also that the novelty and its claimed benefits would not be obvious to those "skilled in the art".
If these principles are valid, then someone inventing a novel combination involving a gene can patent the combination, but cannot use patent law to prevent someone else from using that gene for other purposes or even patenting a different combination involving that gene. John Polkinghorne, carried out a wide public consultation and issued a report in September on all of the moral and ethical issues involved. The Committee found that the concerns were misconceptions rather than of real substance, arising from lack of knowledge, outside the scientific community, of just what was involved.
The Polkinghorne Committee pointed out that because any gene extracted from one species for copying into another, is not itself inserted but is copied in the laboratory and diluted millions of times before a single gene is transferred, the chance that the original gene would be found are much less than the chance of recovering a particular drop of water from all the oceans of the world.
If this were widely understood fears of cannibalism or of contravening religious food taboos would be seen to be unwarranted. Unfortunately, this fact does not make good media copy, whereas sensational stories do. Because what is transferred to the "host" is not the DNA direct from the donor but a laboratory copy of it in familiar terms, it is cut-copy billions of times over -and-paste rather than cut-and-paste the perceived concerns are mistaken, but no less real for that.
As a matter of interest that not many people realise, we are in fact all cannibals - everyone is continuously shedding skin cells, which of course contain their DNA. We are all ingesting the DNA of people around us, or who, for example, have previously been in the same room or public transport. It is noticeable that when "ethical aspects" of GM are raised it is mostly in terms of ethical objections. However, two major reports have included addressing the ethical and social imperatives involved in making the potential benefits of GM available to improve the present and future food supply, especially in developing countries.
A most thorough and balanced study of the ethics, environmental impacts and social aspects of GM was carried out in under the auspices of the Nuffield Foundation. The Nuffield Council on Bioethics carried out a widespread public consultation using a questionnaire posing the ethical, environmental and social issues and issued a comprehensive report on its conclusions and recommendations, "Genetically modified crops: the ethical and social issues". This evoked a supportive response from IFST. Following the consultation, on 28 December the Nuffield Council on Bioethics issued its Report described as a "Follow-up Discussion Paper" on "The use of genetically modified crops in developing countries".
Information and particularly label information about the GM status of foods or ingredients is a topic with polarised views that do not lend themselves to an intermediate position. On the one hand, it is argued that if a food or ingredient has been approved as "safe", the method of production is irrelevant and need not be stated. On the other hand, it is argued that provision of that information is necessary for informed consumer choice, including the consumer who wishes to choose GM, and the consumer who wishes to avoid GM for whatever reason — even an irrational reason or whim. In the EU, the general legislative approach throughout its existence has been that if anything can conceivably be regulated, regulate it.
So it had built a comprehensive system and machinery for considering and approving or otherwise applications for approval of specific lines of GMOs, and for controlling the release of GMOs into the environment.
Likewise, it adopted from the outset the principle of informed consumer choice, which has led to increasingly comprehensive measures, initially voluntary and then by more and more stringent legislation, to provide distinctive labelling of GM foods. In this, as in other aspects, the nature and extent of the regulatory provisions has been influenced by the governments of the Member States, reflecting a public opinion in turn influenced by activist campaigning.