FAQ

Some Frequently Asked Questions on the Effect of Biotechnology on Agriculture, Environment and Food

Agriculture
Environment
Food

AGRICULTURE

What is Sustainable Agriculture?
Innovative and practical solutions are required to increase agricultural productivity in ways that ensure access by all people to the food they need without damaging the environment or depleting natural resources for future generations. Sustainable agriculture is a framework of principles which can be applied to produce sufficient affordable food and fibre in a manner that is environmentally responsible, economically viable and socially acceptable.

What is Integrated Pest Management?
There are many definitions of Integrated Pest Management (IPM). One of the most acceptable is contained in the FAO’s International Code of Conduct on the distribution and use of pesticides (2002):

“Integrated Pest Management (IPM) means the careful consideration of all available pest control techniques and subsequent integration of appropriate measures that discourage the development of pest populations and keep pesticides and other interventions to levels that are economically justified and reduce or minimise risks to human health and the environment. IPM emphasises the growth of a healthy crop with the least possible disruption to agroecosystems and encourages natural pest control mechanisms.”

Pest damage must obviously be controlled if yield, quality, food safety and profit are to be maintained. IPM is a flexible and thoughtful approach that uses the minimum intervention to achieve control. For example, crop rotation can reduce insects and disease organisms reaching a field. Beneficial insects can provide natural or "biological" control of some pests. Selective pesticides and pest-resistant plant varieties are compatible with these methods, contributing to a fully integrated crop management programme.

What is Integrated Crop Management?
Integrated Crop Management (ICM) is a whole-farm strategy that involves managing crops profitably in ways that suit local soil, climatic and environmental conditions, while minimising avoidable environmental impact.

ICM is not prescriptive because it is a dynamic concept: it must have the flexibility to be relevant to any farm, in any country, and it must always be receptive to change and technological advances. It uses the latest research, technology, experience and traditional knowledge in ways that suit local conditions in order to optimise food production, enhance energy conservation and minimise environmental impacts.

What is plant biotechnology?
Biotechnology is defined by the Convention on Biological Diversity as "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use."
More broadly, biotechnology covers biological processing, and can include anything from maize meal production to manufacture of ethanol as motor fuel. To the layman, plant biotechnology has become synonymous with genetic modification (GM), but actually covers a much wider range of techniques including, for example, marker-assisted breeding. Nevertheless, for all practical purposes, plant biotechnology now refers only to the modification of plant DNA, the genetic material of living organisms, to enhance their tolerance to pests and diseases, increase yield, and/or improve quality and nutritional value.

The process by which this is carried out is more properly called recombinant-DNA (r-DNA) technology, and the products are GM seeds or crops or, more generally, genetically modified organisms (GMOs). Modern molecular biology techniques are used to isolate, alter and transfer genes from one organism to another.

In plant biotechnology, genetic engineering allows for the movement of specific and well defined genes within or between plant species, and also to incorporate genes originally found in bacteria or animals. This extends the scope of plant breeding very significantly. Such plants are said to be transgenic.

Biotechnology increases efficiency in developing new varieties of plants, taking years away from the lengthy, trial-and-error traditional breeding process. Nevertheless, the approval process takes much longer and is far more expensive than for conventional varieties, so genetic modification is only used in cases where the same result cannot be obtained via conventional breeding.

Why do we want to make transgenic crops?
The primary benefit of plant biotechnology using genes from other organisms is to increase the amount of genetic variability available for breeders to use. Modern crop varieties generally draw from a rather narrow genetic base, having been bred over many centuries so that they bear little resemblance to their original wild ancestors.
The goal is to allow plant breeders to produce more useful and productive crop varieties by exploiting genes from a wide range of living sources, not just those that can be found within the crop species itself. Progress in traditional plant breeding is limited by the genetic diversity within each crop species, the diversity sometimes available from closely related species, or occasionally useful diversity created within the crop itself by inducing mutations. Often, genes for traits that could be of benefit are not found in a particular crop species, so the ability to make plants with new, desirable traits borrowed from other species represents a major technological advance over conventional breeding methods. Two examples are:

crops, which are tolerant to the herbicide glyphosate. These incorporate a gene discovered in a bacterium and not normally present in plants.
Golden” rice: rice producing vitamin A in its granules, so avoiding vitamin deficiency when rice is used a staple food in developing countries. This uses one gene isolated from daffodils and another one from a bacterium.

The technology is so new. How can we know it is safe?
Biotechnology has been used for thousands of years to produce improved food and healthcare products. Today, modern biotechnology allows us to develop products more safely and rapidly than ever before through a new process called genetic modification, which allows the selection and insertion of individual genes into plant cells. This speeds up the process of breeding desirable traits into plants.

Current science shows that foods made from biotechnology are safe to consume and safe for the environment. The scientific consensus is that the risks associated with food biotechnology products are fundamentally the same as for other foods. GM crops have now been commercially grown for ten years, and were grown on over 80 million hectares of land round the world in 2005. There were many years of research, development and evaluation before any GM seed was planted commercially, and we know far more about these crop varieties than about any others emerging from conventional breeding.

However, a technology is essentially neutral: it is how it is applied which is important. That is why every new development is assessed separately, on a case-by-case basis.

Science has failed in the past. How do we know the science is sound with biotechnology?
No system is ever perfect and life is not without risk. The challenge is to ensure that the regulatory system is rigorous enough to minimise any risk and to capitalise on benefits. For every failure you can think of, there are thousands of products approved every year that safely improve the quality of life: failures we tend to notice, successes we take for granted.

What are genetically modified (GM) organisms?
Genetically modified organisms (GMOs) can be defined as organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. The technology is often called “modern biotechnology”, “gene technology”, “recombinant DNA technology” or “genetic engineering”. It allows selected individual genes to be transferred from one organism into another and also between non-related species.

Who decides if a biotechnology product is safe? Who does the testing?
Genetically modified (GM) food, food additives, and processing aids are subject to comprehensive safety tests before they can enter the marketplace. The same applies to animal feeds made using genetically modified crops. Applicants for a marketing licence are obliged to show, on the basis of tests that have been conducted, that the products in question do not entail any risk for humans, animals, or the environment. Official approval is given only after an exhaustive scientific appraisal of safety-related issues has been made.

In South Africa, objective scientific advice is given by independent experts. However, approval is on the basis of consensus by members of the Executive Council, some of whom vote on socio-economic lines rather than on the basis of scientific advice and evidence.

Is there multilateral regulation of GMO Products?
Several respected international bodies have developed standards for GM products.

Organisations such as the Food and Agriculture Organisation (FAO), the World Health Organisation (WHO) and the Organisation for Economic Cooperation and Development (OECD) are helping to define a multilateral regulatory environment for the products of biotechnology.

The Codex Alimentarius Commission was established in 1962 to administer the Joint FAO/WHO Food Standards Programme. The WTO recognises Codex Alimentarius Commission standards as the international standards of reference for food. Unfortunately, at present, there is no mutual recognition or sharing of data between different regulatory authorities.

In Montreal on January 29, 2000, 138 countries signed the new Cartagena Protocol on Biosafety, ending five years of negotiations under the United Nations Convention on Biological Diversity. This global treaty, which came into force in September 2003, refers to the shipment of genetically modified commodities across borders.

The agreement provides a framework for international science-based rules and procedures. These will be further developed as governments and companies determine how to implement the Protocol in the coming years. The Protocol builds on the base of domestic regulations that already exists in more than 60 nations.

Why don't farmers just go back to growing non-GM crops?
Farmers have the choice to grow either conventional or GM varieties in various crops including corn, soybeans and canola. Since GM crops were introduced in Canada in the mid-90s, for example, farmers embraced this technology. According to the Canola Council of Canada, an estimated 55 per cent of the canola planted in 1999 was genetically modified varieties.

The rapid uptake in Canada and other countries (now, increasingly, in the developing world) and continuing year-on-year growth of GM crop area shows that farmers are getting benefits by growing them. GM seeds are premium priced, but the benefits clearly outweigh the cost. Farmers have a living to make and, in many countries, the freedom to choose what seed they plant. For a variety of reasons – yield, ease of management, overall income for example – more than 8 million farmers round the world are now growing GM crops. All the indications are that the vast majority will continue to do so, and that many others will join them. If they find advantages to growing them and have a ready market for their crops, farmers have no reason to move away from using GM seed.

Isn't it true that pesticides are still used with GMO crops?
It is true that GMO crops do not eliminate the use of pesticides. Both pesticides and pest- and herbicide-resistant GM crops are important for farmers to manage weeds, disease and insects that attack their crops. Used properly, these technologies do not present an unacceptable risk to the environment, the public or the farmer. They are not competing technologies but, rather, complementary solutions to pest management.

Genetically modified crops with built in pest resistance provide one more tool for the farmer's toolbox . More tools increase the effectiveness of Integrated Pest Management (the use of a wide variety of chemical, biological and cultivation techniques to control pests) thereby further contributing to sustainable agriculture. A wide variety of options for crop protection are an important component in managing insect, weed and disease resistance problems.

Although GM crops do not eliminate pesticide use, they can make a significant contribution to reducing the environmental impact of farming. For example, the use of insect-resistant GM cotton has seen a large reduction in use of insecticides: cotton is notoriously difficult to manage, requiring multiple sprays each season to control insect pests inside the cotton bolls. GM cotton produces its own natural insecticide, so dramatically reducing the need for spraying.

Another example is herbicide-resistant crops. Many are resistant to the broad-spectrum herbicide glyphosate, which is among the safest and most environmentally benign crop protection products on the market. So, although spraying is still necessary, its impact on anything other than weeds is minimal.

Does organic mean pesticide-free?
Although it is generally believed that organic crops are grown without treatment, in fact they are often treated with certain naturally-occurring compounds, such as copper salts, which can be toxic.

Organic agriculture is a management system. It specifies what inputs may be used: mainly animal manure and nitrogen-fixing crops as fertiliser, and a small number of naturally-occurring pesticides. However, with the single exception of genetic modification, it says nothing about the composition of the final produce. So, despite the difference in crop management, organic produce has about the same chance of containing measurable residues of approved synthetic pesticides as does a conventionally-managed crop: about 1 in 3.

Consumers do and should have a choice as to what produce they buy, and may well choose organic for reasons other than this. However, there is no evidence to suggest that organic produce is in any way healthier than the standard equivalent.

Are there implications for the rights of farmers to own their crops?
Yes, intellectual property rights are an issue in the debate on GM foods, with an impact on the rights of farmers. Intellectual property rights (IPRs), especially patenting obligations of the TRIPS Agreement, have been discussed in the light of their consequences on the further availability of a diversity of crops. The use of gene technology, also in medicine, raises the conflict between IPRs and an equal access to genetic resources and the sharing of benefits. The potential problems of monopolization and doubts about new patent regulations in the field of genetic sequences have also affected the debate on GM foods.

Why are certain groups concerned about the growing influence of the chemical industry on agriculture?
Certain groups are concerned about what they consider to be an undesirable level of control of seed markets by a few chemical companies. Sustainable agriculture and biodiversity benefit most from the use of a rich variety of crops, both in terms of good crop protection practices as well as from the perspective of society at large and the values attached to food. These groups fear that as a result of the interest of the chemical industry in seed markets, the range of varieties used by farmers may be reduced mainly to GM crops. This would impact on the food basket of a society as well as in the long run on crop protection (for example, with the development of resistance against insect pests and tolerance of certain herbicides). The exclusive use of herbicide-tolerant GM crops would also make the farmer dependent on these chemicals. These groups fear a dominant position of the chemical industry in agricultural development, a trend which they do not consider to be sustainable.

How are GMO products researched and developed?
Many major plant science companies believe in the future benefits of biotechnology and invest millions of dollars in research every year. It can take 10-15 years and millions of dollars to develop a product and bring it to market.
The private sector is particularly active in this area, as the early development of r-DNA technology coincided to a large degree with the withdrawal of the public sector from plant breeding. Nevertheless, public sector breeding is still important, particularly for the developing world, and the R&D process is the same wherever the work is done.
Dedicated scientists spend years developing products. Plants are first modified in laboratories, then growth chambers or greenhouses. The next step in the development process is to test them in the field where they are isolated from other crops to minimise any possible environmental impact. While GM crops have now been on the market for more than ten years, it must be recognized that commercial release has also been preceded by many years of laboratory and field trials.

What further developments can be expected in the area of GMOs?
Future GM organisms are likely to include plants with improved disease or drought resistance, crops with increased nutrient levels, fish species with enhanced growth characteristics and plants or animals producing pharmaceutically important proteins such as vaccines.

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ENVIRONMENT

What are the issues of concern for the environment?
Issues of concern include:

the capability of the GMO to escape and potentially introduce the engineered genes into wild populations;
the persistence of the gene after the GMO has been harvested;
the susceptibility of non-target organisms (e.g. insects which are not pests) to the gene product;
the stability of the gene;
the reduction in the spectrum of other plants including loss of biodiversity; and
increased use of chemical pesticides.

Aren't we putting the environment at risk by releasing GMOs into it?
Current science shows that biotech varieties authorised for commercial planting are safe for the environment. No-one can predict anything with 100% assurance, but the regulatory system that exists provides that every possible precaution is taken in assessing the safety of foods before they are made available to the consumer.

Plants with novel traits are regulated alongside similar products developed using traditional technologies, but generally much more stringently. For example, in most countries a herbicide-tolerant variety produced using biotechnology is subject to far more intense scrutiny than a conventionally bred variety with exactly the same trait. This is despite the fact that there is no reason to suppose a priori that the environmental impact would be any different.

Every GM-produced trait in a particular crop is examined for:

the potential for plants to spread and transfer genetic material to other species
possible harm to non-target species
the disruption of balance in natural ecosystems through the replacement of species, and
the loss of biodiversity (diversity of species, variation of characteristics).

How is a risk assessment for the environment performed?
Environmental risk assessments cover both the GMO concerned and the potential receiving environment. The assessment process includes evaluation of the characteristics of the GMO and its effect and stability in the environment, combined with ecological characteristics of the environment in which the introduction will take place. The assessment also includes unintended effects which could result from the insertion of the new gene.

What about the study that showed genetically modified maize kills Monarch butterflies?
In May 1999, Nature magazine published a letter from researchers at Cornell University that reported findings suggesting further research was needed into the effect of pollen from selected strains of Bt corn on the Monarch caterpillar. Since that publication, many university researchers, including others at Cornell, have stepped forward to stress that the Monarch study did not represent natural conditions. In practice, the planting of large areas of GM corn in the American Mid-West has had no effect on the population of Monarch butterflies, which have continued to fluctuate according to variations in other factors.

Extensive environmental research has confirmed the safety of Bt corn on non-target insects, such as the ladybird beetle, honeybee and the green lacewing, in the natural environment.

What is a risk?
‘Risk’ has been defined as a function of the probability of an adverse effect and of its severity. Adverse effects on the environment result from ‘hazards’, which are potentially harmful agents (biological, physical or chemical) but whether and to what extent these hazards will actually cause harm must be approached on probabilistic terms : the exposure to the hazard and the severity of the effect will finally determine the risk.
If we take the example of the Monarch butterfly controversy, much of the dispute was caused by a misunderstanding of the notions of risk and hazard. In this case it was proven in laboratory experiments that pollen from transgenic Bt-maize was a hazard for the larvae of the Monarch butterfly, in the sense that Bt toxins fed to the larvae could kill them. But what is the risk for the Monarch butterflies in the crop environment ? Further analyses are needed for answering the question, measuring the amounts of pollen spread in the environment, the presence of the larvae at that time, analyzing the feeding behaviour of the larvae, hence the actual exposure of the insects to the Bt-pollen, etc. A team of scientists concluded that, although the Bt-pollen is a hazard for the Monarch butterfly larvae, the associated risk in the crop environment is negligible.

Tell me more about the scientific vs. social acceptability of risks
While it is possible to demonstrate a risk, by measuring the harm caused by a given hazard in a given environment, it is impossible to demonstrate the absence of risk in a really convincing way, as no empirical proof of the absence of something can be obtained! In such a circumstance, demonstrating the zero-risk is not a reasonable demand before deciding to license or not the marketing of a new product. Instead, the acceptability of a risk (actual or potential) will have to be determined. In this respect, scientific acceptability and social acceptability are two different things.
For the scientist, the acceptance of a risk will first be stated when the occurrence of severe and/or irreversible damage to health and the environment may reasonably be ruled out, based on the latest scientific information. Further, it will depend on a comparison between the actual and potential harms caused by the innovation with those caused by the existing technical scenarios that the innovation intends to substitute. To make it clear, assessing a transgenic plant with insect resistance as a new trait will be done by comparing the environmental consequences of using this plant with the consequences of using the chemical insecticides that are needed when a plant is non transgenic, hence susceptible to the pest. Scientific risk assessment thus needs so-called “comparators”, i.e. widely-used practices with which the innovation may be compared.

For lay persons, social acceptability is even more complex, as it is bound to values and norms, hence subjective in the sense that human communities and individuals may have contrasting appraisals of the innovation. In order to make the innovation socially acceptable, the informed consent of the consumer must be sought. This demands sound information on the new product. In this context, public education to science and technology is essential for making the innovation understandable.

Do GM crop plants threaten biodiversity and the environment?
GM crops are questioned as to their impacts - actual or potential, direct or indirect - to the biological communities of field and wild environments. The scientific assessment of these questions is highly complex, both from a methodological point of view (where and how to gather the relevant information?) and for the interpretation and use of the data (how can we transpose the data from one geographic area to another, from laboratory or field experiments to commercial releases?).
At the same time, it is a hot topic in the GM debate and a challenge for the regulatory authorities in charge of the environmental risk assessment (‘ERA’). One way to answer is to look at the current situation after ten years of GM crop cultivation, on millions hectares worldwide. As concluded by a recent and authoritative report of the Swiss Expert Committee for Biosafety reviewing mainly peer-reviewed scientific literature and reports form international organizations , “the data available up to now do not provide any scientific evidence for harm caused to the environment by commercial cultivation of GM crops”.
Nevertheless, current applications are restricted to only a few traits and it is essential to bear in mind that ERA needs a step wise, case-by-case study of each trait/plant/environment combination. ERA addresses both the adverse effects on non target organisms and the invasiveness of the GM plants and their possible progenies, including potential hybrids with wild relatives. Laboratory and field trials have been systematically conducted on the current commercial traits. Although harmful effects have incidentally been demonstrated in artificial conditions, like the toxic potential of Bt-pollen fed to Monarch butterfly larvae, the ecological risk, pertaining to the probability of the harm in the actual field environment was concluded as very low, hence acceptable in comparison with the existing crop protection practices (insecticide application). Understanding the difference between hazard and risk is thus essential.

Do GM plants create “super weeds”?
Weediness is a complex trait that refers to the capacity of weeds and the weedy individuals of cultivated species to maintain their populations in the field environment and to resist the crop management practices aiming at getting rid of them. This problem is essentially due to herbicide resistance and has been documented since the 1970’s.
In 1997, 183 resistant weed biotypes were listed from 42 countries . This is before the large-scale field release of GM plants and obviously indicates that GM technology is not at the origin of the problem. The question remains as to whether GM plants may exacerbate the problem. This is an important question considering the overwhelming success of glyphosate tolerance, introduced into soybean, cotton and maize. Selection of herbicide-resistant biotypes is indeed enhanced by the use of a few molecules on large areas and over successive years. Where a few molecules are repeatedly applied on the same areas, multiple resistance may also occur, giving rise to ‘superweeds’ with stacked resistance genes. In fact glyphosate and glufosinate tolerance – the two most popular herbicides used by GM technology - are so efficient that they also promote ‘conservation tillage’ in many areas, a sustainable cropping system reducing tillage and preserving agricultural soils, but requiring efficient weed killing techniques, like GM herbicide tolerance. In order to benefit from the agroecological advantages of GM herbicide tolerant plants in the long term, stewardship plans need to be adopted, diminishing the risks of herbicide resistance in weed populations. Such management plans have been proposed.

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FOOD

What are genetically modified foods?
Genetically modified organisms (GMOs) can be defined as organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally. This technology is used to create GM plants – which are then used to grow GM food crops.

Why are GM foods produced?
GM foods are developed – and marketed – because there is some advantage to the producer or consumer. This could mean a product with a lower price, greater benefit (in terms of durability or nutritional value) or both. Initially GM seed developers wanted their products to be accepted by farmers and so they have concentrated on innovations that producers (and the food industry) would appreciate.
The initial objective for developing GM plants was to improve crop protection. The GM crops currently on the market are mainly aimed at increasing the level of protection through the introduction of resistance against plant diseases caused by insects or viruses or through increased tolerance towards herbicides.
Insect resistance is achieved by incorporating into the food plant the gene for toxin production from the bacterium Bacillus thuringiensis (Bt). This toxin is currently used as a conventional insecticide in agriculture and is safe for human consumption. GM crops that permanently produce this toxin have been shown to require lower quantities of insecticides in specific situations, e.g. where pest pressure is high.
Virus resistance is achieved through the introduction of a gene from certain viruses which cause disease in plants. Virus resistance makes plants less susceptible to diseases caused by such viruses, resulting in higher crop yields.
Herbicide tolerance is achieved through the introduction of a gene from a bacterium conveying resistance to some herbicides. In situations where weed pressure is high, the use of such crops has resulted in a reduction in the quantity of the herbicides used.

Are GM foods assessed differently from traditional foods?
Generally consumers consider that traditional foods (that have often been eaten for thousands of years) are safe. When new foods are developed by natural methods, some of the existing characteristics of foods can be altered, either in a positive or a negative way. National food authorities may be called upon to examine traditional foods, but this is not always the case. Indeed, new plants developed through traditional breeding techniques may not be evaluated rigorously using risk assessment techniques.
With GM foods most national authorities consider that specific assessments are necessary. Specific systems have been set up for the rigorous evaluation of GM organisms and GM foods relative to both human health and the environment. Similar evaluations are generally not performed for traditional foods. Hence there is a significant difference in the evaluation process prior to marketing for these two groups of food.

How are the potential risks to human health determined?
The safety assessment of GM foods generally investigates:

direct health effects (toxicity),
tendencies to provoke allergic reaction (allergenicity);
specific components thought to have nutritional or toxic properties;
the stability of the inserted gene;
nutritional effects associated with genetic modification; and
any unintended effects which could result from the gene insertion.

What are the main issues of concern for human health?
The three main issues debated are tendencies to provoke allergic reaction (allergenicity), gene transfer and outcrossing.

Allergenicity - In principle, the transfer of genes from commonly allergenic foods is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic. While traditionally developed foods are not generally tested for allergenicity, protocols for tests for GM foods have been evaluated by the Food and Agriculture Organization of the United Nations (FAO) and WHO. No allergic effects have been found relative to GM foods currently on the market.

Gene transfer - Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used in creating GMOs, were to be transferred. Although the probability of transfer is low, the use of technology without antibiotic resistance genes has been encouraged by a recent FAO/WHO expert panel.

Outcrossing - The movement of genes from GM plants into conventional crops or related species in the wild (referred to as “outcrossing”), as well as the mixing of crops derived from conventional seeds with those grown using GM crops, may have an indirect effect on food safety and food security. This risk is real, as was shown when traces of a maize type which was only approved for feed use appeared in maize products for human consumption in the United States of America. Several countries have adopted strategies to reduce mixing, including a clear separation of the fields within which GM crops and conventional crops are grown.

Feasibility and methods for post-marketing monitoring of GM food products, for the continued surveillance of the safety of GM food products, are under discussion.

Are GM foods safe?
Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.
GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous use of risk assessments based on the Codex principles and, where appropriate, including post market monitoring, should form the basis for evaluating the safety of GM foods.

How are GM foods regulated nationally?
In some countries GM foods are not yet regulated. Countries which have legislation in place focus primarily on assessment of risks for consumer health. Countries which have provisions for GM foods usually also regulate GMOs in general, taking into account health and environmental risks, as well as control- and trade-related issues (such as potential testing and labelling regimes). In view of the dynamics of the debate on GM foods, legislation is likely to continue to evolve.

What kind of GM foods are on the market internationally?
All GM crops available on the international market today have been designed using one of three basic traits: resistance to insect damage; resistance to viral infections; and tolerance towards certain herbicides. All the genes used to modify crops are derived from micro-organisms.

Have GM products on the international market passed a risk assessment?
The GM products that are currently on the international market have all passed risk assessments conducted by national authorities. These different assessments in general follow the same basic principles, including an assessment of environmental and human health risk. These assessments are thorough, they have not indicated any risk to human health.

Why has there been concern about GM foods among some politicians, public interest groups and consumers, especially in Europe?
Since the first introduction on the market in the mid-1990s of a major GM food, herbicide-resistant soybeans, there has been increasing concern about such food among politicians, activists and consumers, especially in Europe. Several factors are involved.
In the late 1980s – early 1990s, the results of years of molecular research reached the public domain. Until that time, consumers were generally not very aware of the potential of this research. In the case of food, consumers started to wonder about safety because they perceive that modern biotechnology was leading to the creation of new species.
Consumers frequently ask what’s in it for them? Where medicines are concerned, most consumers readily accept biotechnology as beneficial for their health (e.g. medicines with improved treatment potential). In the case of the first GM foods introduced onto the European market, the products were of no apparent direct benefit to consumers (not cheaper, no increased shelf-life, no better taste). The potential for GM seeds to result in bigger yields per cultivated area should lead to lower prices but public attention has focused on the risk side of the situation.
Consumer confidence in the safety of European food decreased significantly as a result of a number of food scares that took place in the second half of the 1990s that were unrelated to GM foods. This has also had an impact on discussions about the acceptability of GM foods. Consumers have questioned the validity of risk assessments, both with regard to consumer health and environmental risks, focusing in particular on long-term effects. Other topics for debate by consumer organizations have included allergenicity and antimicrobial resistance.
Consumer concerns have started a discussion on the desirability of labelling GM foods, thereby allowing the consumer to make an informed choice. At the same time, it has proved difficult to detect traces of GMOs in foods which means that very low concentrations often cannot be detected.

What is the state of public debate on GM foods in other regions of the world?
The release of GMOs into the environment and the marketing of GM foods have resulted in a public debate in many parts of the world. This debate is likely to continue, probably in the broader context of other uses of biotechnology (e.g. in human medicine) and their consequences for human societies. Even though the issues under debate are usually very similar (costs and benefits, safety issues), the outcome of the debate differs from country to country. On issues such as labelling and traceability of GM foods as a way to address consumer concerns, there is no consensus to date. On the other hand, significant progress has been made on the harmonization of views concerning risk assessment.
The humanitarian crisis in southern Africa has drawn attention to the use of GM food as food aid in emergency situations. A number of governments in the region raised concerns relating to environmental and food safety fears. Although workable solutions have been found for distribution of milled grain, some countries have restricted the use of GM food aid and obtained commodities which do not contain GMOs.

Are people’s reactions related to the different attitudes to food in various regions of the world?
Depending on the region of the world, people often have different attitudes to food. In addition to nutritional value, food often has societal and historical connotations, and in some instances may have religious importance. Technological modification of food and food production can evoke a negative response among consumers, especially in the absence of good communication on risk assessment efforts and cost/benefit evaluations.

What are novel foods?
"Novel foods are foods that have previously not been available for sale, have been substantially modified from traditional composition, or are produced by a novel food process, including genetically engineered food products." This includes, for example, fruit and vegetables imported for the first time into a region where they have never formed part of the diet.

All novel foods must be assessed for safety to humans, animals and the environment before receiving regulatory approval. As part of the scientific assessment, the principal of "substantial equivalence" is applied. This refers to comparing the novel product to its conventional counterpart. Substantial equivalence helps to determine what characteristics of a novel food must be examined in more detail.

All novel foods approved to date have conventional counterparts. Only novel products that are judged to be as safe as their conventional counterparts are approved for use.

Is the nutritional value of GMO foods different?
It depends on the reason for making the modification. Herbicide-tolerant or insect-resistant crops, for example, which form the vast majority of GM crops currently grown are, to all intents and purposes, identical to their non-GM counterparts. However, biotechnology can alter the nutritional composition of foods in a dramatic and very positive way. For example there are genetically enhanced rice strains with a high Vitamin A content (“golden rice”), or tomatoes with high levels of lycopene, both still in development. Other groups are working on biotech routes to produce rice and soya with reduced potential to cause allergies.

Do GMO foods look or taste different?
With few exceptions, GMO products look and taste the same as their conventional counterparts. One example of a GMO product being researched that looks different is "golden rice." This rice has a distinctive orange colour due to the increased level of Vitamin A brought about by genetic engineering.

What are some of the benefits of genetically modified foods?
The benefits biotechnology can deliver are many. Most of the examples below have been shown to work but are not yet commercial.

For Consumers:

fruits, vegetables and cereals that are more nutritious, taste better and keep longer.
processed foods that are healthier. For example, lower saturated fats in soybeans and in canola oil.
foods that help us fight disease better.
more dependable crop yields, which ultimately has an effect on the price paid at the grocery store. long-term research is looking at increased tolerance for drought, flood, heat, cold, salt or metals in the soil.
nutraceuticals - foods that can deliver vaccines and medicines.

For Farmers:

crops resistant to disease.
crops that protect themselves from pests.
crops that make it easier for farmers to control weeds.
crops that require less preparation of the soil, meaning less erosion
more flexible crop management and more consistent yields.

Is it true that 70% of our foods are genetically modified?
No, the fact is that 70% of processed foods (in countries such as the USA where GM ingredients are widely used in the food chain) may contain ingredients from genetically modified crops such as canola, soybean or corn.

Why are genetically modified foods banned in Europe?
GM foods are not banned in Europe. A number of GM crops have been authorised for both food and animal feed use, and millions of tonnes of GM soy are imported annually as animal feed. However, most food manufacturers have formulated GM ingredients out of their products because of the negative publicity surrounding the initial import of GM soy.

The exception is for processing aids such as enzymes. EU law does not require these to be labelled, whatever their source, and GM-derived enzymes are in common use to process foods. For example, the majority of hard cheese in Europe is produced using transgenic chymosin, the milk-clotting enzyme which also occurs in rennet.

Insect resistant GM maize has also been grown in northern Spain for a number of years without any problem: on nearly 60,000 hectares in 2005. The success of this has led a number of farmers in southern France to follow suit, although official statistics do not exist for the area grown.

Although there was a de facto moratorium in place until comparatively recently, while a few regulatory issues were addressed to the satisfaction of all Member States, a number of new GM crops have recently received approval for import and use in the food chain.

Because of the experience of Mad Cow disease, the dioxin scare and other similar incidents, European consumers do not have the same faith in their regulatory systems as in other countries, and are generally more suspicious of both science and authority figures. In addition, environmental NGOs are more influential than in the USA. This overall context created a situation where major retailers as a group found it simpler to reformulate products than to risk losing competitiveness.

Which countries accept GMO exports? Which countries don't? Why?
The U.S., Japan, China and Mexico, Thailand, Argentina, and Chile are purchasing products derived from transgenic crops. India and Korea also import some canola products. Approximately 98% of genetically modified corn produced in Canada has been approved for sale in Europe. All soybean varieties, including herbicide tolerant, have been approved for export to Europe and other trading partners.

What is being done to address the long-term impacts of genetically modified foods?
Research on genetically modified foods and crops is ongoing and each year, the mountain of scientific data that illustrates the technology is sound and safe continues to grow. Research knowledge and familiarity with this technology is based on thousands of experiments and tests that extend over more than 25 years. It must also be recognised that commercial release of these varieties was preceded by many years of laboratory and field trials. Over the last 15 years, tens of thousands of field tests have been conducted on more than 30 crops around the world.

Current science shows that genetically modified foods now approved are as safe to consume as their conventional counterparts. While there is no such thing as "zero risk" for any food, consumers can be confident that foods produced using biotechnology meet the most stringent food safety standards. There is absolutely no sound reason to suppose that currently approved food crops will have any long term negative impacts, either on consumers or the environment.

Many leading scientists are warning us about the dangers of GMO foods. How can they be wrong?
There are a few, very vocal scientists who oppose genetically modified foods. An overwhelming majority of scientists with expertise in the areas of molecular biology and biotechnology have no concerns about the use of genetic modification in principle. However, like any tool, biotechnology can be used well or badly. The stringent approvals procedures in place round the world, which look at each individual case, are there precisely to ensure that any potentially risky applications never become commercialised. Debate and disagreement among scientists is not new. Leading edge science tends to be controversial and can generate mixed opinions among the experts.

There is so much conflicting information about this issue. Where can I get unbiased information?
For unbiased information about biotechnology and genetic engineering related to food, you can take a look at the following links:

Why aren't genetically modified foods labelled in America?

What is the status of labelling GMOs in other countries?
Labelling requirements vary by country. In the EU, process-based labelling is required: any ingredient or product containing more than 0.9% GM material, or being derived from a GM source, must be labelled. This means, for example, that oil from GM soya would have to be labelled as such even though it contained no detectable transgenic DNA or protein and was analytically indistinguishable from a conventional equivalent.

Japan has developed mandatory labelling. Their guidelines are based on science and a realistic approach to labelling. Korea, Thailand and Hong Kong are also considering mandatory labelling.

Why can't genetically modified crops just be segregated and labelled?
Segregation of crops is the process of completely separating GMO from non-GMO crops. Segregation is possible and tests do exist that identify whether crops and ingredients have been genetically altered. However, there are some limitations on what they can test for, commercial availability, and cost effectiveness.

Grain segregation, for instance, is possible only if the producer carefully harvests, stores and transports GMO grain separately from non-GMO grain. It may be extremely difficult for the farmer to properly clean all storage and transport units to ensure a totally pure end product. To change grain handling and food processing systems to segregate all GMOs from non-GMOs would be a cumbersome and costly process. The decision whether or not to proceed down this path therefore requires careful consideration.

It is not often recognised that all agricultural commodities are impure to some extent: several percent of various impurities are tolerated quite legally in anything from cereal grains to olive oil. However, the tolerance in the case of GMOs has been set much lower: 0.9% in the EU, for example.

Aren't genetically modified foods more dangerous than non-GMO foods?
No, in fact, in the future specific GMO foods might even be safer for people with specific allergies then their non-GMO counterparts.

Foods from crops modified using biotechnology are evaluated for safety according to processes endorsed by the United Nations Food and Agriculture Organisation and the World Health Organisation. Far more is known about them in detail than any other foods we eat.

Is it safe to eat meat or poultry from animals that have been fed genetically modified grains?
Yes, research indicates animals fed GMO crops are no different than those fed conventional feeds. Proteins from GMO feeds have not been detected in milk, egg products or meat.

It is clear that allergens are transferred through genetic engineering. What about people with life-threatening food allergies?
Genetic modification is used to introduce individual genes with known properties into a plant so it is possible to precisely test the risk of allergic potential in connection with genetically modified food products.

The results of comprehensive investigations have revealed no increased allergy risk connected with genetically modified plants that have been approved so far compared with conventional plants and their products.

Neither do the genes and proteins that have been used so far (herbicide- and antibiotic-resistance genes, insecticidal proteins from Bacillus thuringiensis, or viral proteins) originate from sources with an allergenic potential, nor have comparisons with known allergens demonstrated any similarities. Most of the specified proteins have already been part of the human diet.

In the approval procedure for genetically modified food, the allergenic potential of the protein introduced into the plant must be investigated. In two cases, development of GM varieties under test were stopped at a relatively early stage because tests picked up allergenicity problems. One case was of soy modified with a gene from the Brazil nut (to which a significant number of people are allergic). In the other, more recent, case, peas had been modified to be pest resistant. However, the gene used, isolated from field beans, expressed a protein which gave allergic reactions in mice.

Genetic modification can be expected to contribute towards the avoidance of food allergies as allergens can be inactivated or completely eliminated by these techniques. This is being attempted in Japan with rice, which contains proteins that trigger an allergic reaction in Japanese people in particular. Efforts to cultivate such a hypoallergenic rice variety are currently being undertaken in various laboratories; as yet, however, these efforts have yielded only partial success, since it has not been possible to fully eliminate all allergens.
Genetic modification is also very helpful in the areas of diagnosis and elucidation of the causes of allergies. A number of new anti-allergy pharmaceuticals have already been developed; these are currently undergoing clinical trials.

Haven't medical experts warned that antibiotics could become useless because of genetic engineering's use of antibiotic-resistant genes?
An increasing range of disease-causing bacteria is becoming resistant to one or more common antibiotics. This is mainly because of their ability to evolve and adapt to constant exposure to these drugs, both in humans and animals. The additional role marker genes in GM crops might play has been the subject of intense debate.

Antibiotic resistance markers (ARMs) have been important tools for the development of many genetically modified crops. They are derived from naturally occurring bacteria to which the human population have been exposed for thousands of years.

The safety of antibiotic resistance genes in genetically modified plants has been thoroughly studied for more than 10 years. Experimentation shows that their use does not add any measurable risk to the environment or to human health. Nevertheless, a highly precautionary approach has been taken in the EU and a decision taken to phase out crops containing certain ARMs. Antibiotic resistance will continue to develop, unfortunately, because of the widespread use (and misuse) of these drugs in human and veterinary medicine.

An alternative marker system uses the gene for a naturally derived enzyme, phospho-mannose isomerase. This particular enzyme enables plant cells to use a sugar called mannose as a source of energy. The cells that manage to grow in the presence of mannose have acquired the marker gene and have therefore also taken up the other genes of interest.

This system, and also other ones based on other sugars, should allay the fear that GM poses a danger to human health. These should allow a refocusing of effort to tackle the overuse of antibiotics in intensive farming and their over-prescription in medicine which pose a far greater threat to our health.

Is there any chance that genetic engineering will lead to increased hunger and starvation?
It is an unfortunate fact that, although well intentioned, many people in the development sector are ideologically opposed both to crop biotechnology and private sector involvement. Some have a vision of the developing world feeding itself by relying on traditional subsistence agriculture. In the case of cash crops, for those who have more than enough land to feed themselves, the prescription is for organic crops to be grown. In practice, farmers in developing countries have just as much need for the best available technologies as do their counterparts in the North. Genetic engineering is a tool which, used properly, could improve the food security of poor people. This is recognised by many who are trying to help with agricultural development: crop biotechnology projects are being funded by the Gates and Rockefeller Foundations, for example.
Criticism of GM crops for the developing world is often based on the assumption that farmers will have their livelihoods controlled by large international companies, from whom they will be forced to buy seed every year. This is an unfortunate misconception, since people will continue to be free to choose whatever seed they wish, and it is certainly not in the interests of plant science companies to disadvantage poor farmers in the pursuit of short-term profit, as some activists claim would happen.

In fact, biotechnology may help to feed the world as the population climbs to a predicted 9 billion by 2050. The amount of land currently committed to food production—36% of the earth's cumulative land mass--cannot yield the amount of food needed by the increased population at current yield levels. Experts predict that we would need to double or triple the world's food production to provide enough food for everyone, particularly as meat consumption increases. Without using all the tools at our disposal, including biotechnology, we would need to increase the amount of land in production substantially, impacting wildlife and native plants and resulting in the clearing of forests.

Though the production of GM crops is growing in developing countries, they should not be regarded as magic bullets that will eliminate poverty and hunger, because these global problems have significant political and social components that influence the availability of food even where it can be grown in sufficient amounts.

Does GM food cause allergy or any health problem to men and animals?
After ten years of food and feed use of GM plants, no hazard to human or animal health associated with the consumption of marketed GM products has been formally reported, despite frequent rumours and media assaults against GM.
The current pre-marketing risk assessment goes beyond all existing procedures applying to conventional food and makes GM food one of the safest available on the markets. In this risk evaluation procedure, both direct effects of the newly introduced proteins and DNA, and indirect effects due to compositional changes (intended or unintended) are examined. Direct effects include toxic and allergic effects, and are studied on a case by case. A range of statistical and experimental approaches are used, complying to international standards and guidelines. These include informatics analysis of the newly introduced proteins and comparison with known toxins and allergens, in vitro tests like protein reactivity with sera from allergic patients, and rat feeding tests with isolated components or whole plant materials.
Furthermore, when discussing the effect of GM plants and food on human health, it should be reminded that currently marketed GM plants can also positively contribute to human health: reduced pesticide use with Bt cotton has been shown to improve health of farm workers in China and insect protection via Bt technology reduces mycotoxin contamination of maize. Active research and development are also underway for improving nutritional qualities of food and for eliminating allergens which are naturally found in major food crops, like rice, wheat and soybean.

Does GM food increase resistance of pathogenic bacteria to antibiotics?
Antibiotic resistance (AR) genes may be used in laboratories as a tool for selecting plant cells transformed by exogenous DNA. The gene of interest is physically linked to the AR gene by recombinant DNA technology and selection of the few resistant cells after DNA delivery ensures that they also contain the DNA encoding the useful trait. Such ‘selectable markers’ are commonly used by geneticists for transforming microbial cells and they have been successfully applied to plant cells. As a result, the regenerated plant and its progeny contain the AR gene, as a remnant of the technical procedure and with no more practical interest at the commercialization stage. Since antibiotics are essential to the safeguard of human and animal health and considering the pressing problem of multiple resistance developing in bacterial pathogens, concerns have been raised on the use of AR selection markers in GM plants, food and feed. Could these genes from marketed GM plants increase the frequency of antibiotic resistant pathogenic bacteria, in the short or in the long term? For defining the risk, several aspects must be taken into consideration: the therapeutic relevance of the antibiotic (based on the current and potential use), the occurrence of resistance genes in the environment (natural and human-associated habitats) ; the possibility of gene transfer from GM plant material to bacteria. When adopting this reasoning to the only AR gene found in GM plants today (and most likely in the future) – the nptII gene conferring resistance to a range of aminoglycosides, like kanamycin and neomycin -, it may be concluded that the presence of this marker gene poses negligible risk, immediate or delayed, to human and animal health.

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