Genetically Modied Organisms (GMOs)

R Peter and J Mojca, University of Ljubljana, Ljubljana, Slovenia , Zalog, Postojna, Slovenia P Primoz
& 2011 Elsevier B.V. All rights reserved.

Abbreviations
BSE EFSA EPA EU FDA GM GMO IPPC LMO OECD USDA bovine spongiform encephalopathy European Food Safety Agency Environmental Protection Agency European Union US Food and Drug Administration genetically modied genetically modied organism International Plant Protection Convention living modied organism Organisation for Economic Co-operation and Development US Department of Agriculture

Introduction
Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release of genetically modied organisms (GMOs) into the environment denes a GMO as an organism, with the exception of the human being, in which the genetic material has been altered in a way that does not occur naturally by mating or by natural recombination. Natural recombination is a technique using recombinant nucleic acids, which also include new genetic material by adding nucleic acid molecules. Molecules can be formed outside the organism, for example, with the help of virus, bacterial plasmid, or other vector in a host organism. Vector does not harm the host organism, but is successfully multiplied in it. This is a method involving the direct introduction of heritable material, formed outside the organism, including microinjection, macroinjection, and microencapsulation. It is a cell fusion or cell hybridization technique, in which live cells with new combinations of heritable genetic materials are formed through the fusion of two or more cells by methods that do not occur naturally. From the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, a new term living modied organisms (LMOs) is used instead of GMO. It stands for living modied organisms that have been genetically modied through the application of modern biotechnology. Modern biotechnology includes nucleic acid techniques in vitro, including recombinant DNA, direct

injection of nucleic acids into cells or organelles, and cell merging above their taxonomic category, which reaches above natural physiological reproductive barriers and techniques, which are not used in traditional multiplication and selection. GMOs have already entered the food chain in most parts of the world. Many microorganisms, mainly bacteria, have been modied to increase the production of proteins, amino acids, and commercial chemicals. Pioneer works with GMOs are related to the discovery of a natural phenomenon mutagenesis, which helped to develop different kinds of microorganisms. These mutants were the rst scientic tools in this eld, but represented a commercial prot for the fermentation industry at the same time. Plants were the rst generation of microorganisms, but were available only in few markets. The GMO market has been released by the development of science and genetic information of a wide range of organisms. A consequential expansion has caused increased concern over genetic engineering use in food industry and eventual harmful impacts on human health and environment.

State of the Art in GMO Research and Development

The creation of the rst recombinant bacteria was in 1973, that is, Escherichia coli expressing a Salmonella gene. Herbert Boyer then founded the rst company to use recombinant DNA technology, Genentech, and in 1978, the company announced the creation of an E. coli strain producing the human protein insulin. In 1986, eld tests were conducted of bacteria genetically engineered to protect plants from frost damage at a small biotechnology company called Advanced Genetic Sciences. In the same year, Monsantos proposed eld test of a microbe genetically engineered for a pest resistance protein was dropped. Status of GMOs in Agriculture and Food Production The rst commercially grown genetically modied (GM) food crop was a tomato created by Calgene called the FlavrSavr. Calgene submitted it to the US Food and Drug Administration (FDA) for testing in 1992, following the FDAs determination that this transgene was actually a tomato, did not constitute a health hazard, and did not

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need to be labeled as GMO. Calgene released it into the market in 1994, where it was met with little public comment. Subsequent GM food crops included virusresistant squash, a potato variant that included an organic pesticide called Bt (Note: the Environmental Protection Agency (EPA) classied the Bt potato as a pesticide, but required no labeling), strains of canola, soybean, corn, and cotton engineered by Monsanto to be immune to their popular herbicide Roundup, and Bt corn, which is resistant to corn borer. Production of GM crops is currently concentrated in just a few countries (USA, Argentina, Canada, and China) and to just a few crops (soybean, corn, cotton, and canola) (Table 1). GM viruses could also have great medical ramications in the near future. The FDA also recognized as GRAS transgene wine yeast with malolactic activity in 2003. Scientists have recently modied Streptococcus mutans to produce ethanol. This transgenic bacterium, if properly colonized in a persons mouth, could eliminate cavities and other tooth-related issues. Transgenic animals are used as experimental models to perform phenotypic tests with genes whose function is unknown or to generate animals that are susceptible to certain compounds or stresses for testing in biomedical research. Other applications in animals include the production of human hormones, such as insulin. At the National University of Singapore, researchers have been developing a transgen as pollution indicators by genetically manipulating zebra sh to uoresce in different ways. The GloFish was produced by injecting zebra sh eggs with the gene of a sea anemone, which makes it red colored. A zebra sh that glows when illuminated is now available for aquarium owners under the brand name GloFishTM. As it is not meant for human consumption but for aquariums, the
Table 1 Food Soybeans Corn Main GM crops in agriculture until 2008 Properties of the genetically modied variety Resistant to herbicides

US FDA saw no need to regulate it and allowed Yorktown Technologies LP (Austin, TX, USA), the licensee for GloFish, to market and sell it. In fact, it is possible that such a sh could be on the market as early as 2008. The GM salmon, which grows twice as fast as normal farmed salmon, and looks and tastes like normal salmon, is also one very promising solution. Transgenic fruit ies (Drosophila melanogaster) are frequently used in genetic research as genetic models to study the effects of genetic changes on development. Transgenic mice are often used to study cellular and tissue-specic responses to disease. There are many other ideas to construct transgene organisms to improve human life.

Hazard Analysis and Risk Management Risk assessment is a very important part of risk management in food production and also in the case of a new characteristic introduced by transgene technology. A hazard (harmful characteristic) is identied as the potential of an organism to cause harm to or adverse effects on human health and the environment. A risk is the combination of the magnitude of the consequences of a hazard, if it occurs, and the likelihood that consequences will occur. The goal of risk assessment is to inform the decision-making process to ensure public protection against unacceptable risks. Very important is guidance how to tailor the test strategy to characteristics of GM foods and introduced traits. In practice, there are two approaches: scientic principles (toxicity tests, digestibility tests, etc.) and principles of comprehensive evaluation (substantial equivalence, the precautionary principle).

Specic genetic modication Herbicide-resistant gene taken from bacteria inserted into soybean New gene added/transferred into plant genome

Cotton Tomatoes

Resistance to certain pesticides (tolerating crop spray this way a farmer can use large amounts of pesticides that would normally kill the plant, without harming it) Pest-resistant cotton Variety that does not rot (degrade) as fast the genetically modied tomatoes do not produce a substance that normally causes tomatoes to rot

New gene added/transferred into plant genome First genetically modied tomatoes contained genes that made them resistant to antibiotics. After concern from doctors and the medical community, tomatoes are now genetically modied in an alternative way New gene added/transferred into plant genome New gene added/transferred into plant genome Insect-killing gene added to the plant. The gene comes from the bacteria Bacillus thuringiensis Three new genes implanted: two from daffodils and the third from a bacterium

Potatoes Rapeseed (canola) Sugarcane Sweet corn Rice

Resistance to certain pesticides (tolerating crop spray) Resistance to certain pesticides (tolerating crop spray) Produces its own insecticide (a toxin to insects, so insect attacks are less likely) Genetically modied to contain high amounts of vitamin A (beta-carotene)

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At the end of the 1980s the food safety assessment of genetically engineered foods was for the rst time discussed at the international level. The point of the safety assessment should be to determine whether the modied food is as safe as its traditional counterpart. In these discussions the concept of substantial equivalence was introduced as a means of establishing a benchmark denition of safe food. This concept was introduced by the Organization for Economic Co-operation and Development (OECD) Group of National Experts on Safety in Biotechnology as an approach to assessing the food safety of GMOs, and has been further elaborated on by other groups. The determination of substantial equivalence is not the point of a safety assessment, but rather a practical approach that guides the safety assessment process. When there are reasonable grounds for concern that potential hazards may affect the environment or human, animal, or plant health, and when at the same time the available data precludes a detailed risk evaluation, the precautionary principle has been politically accepted as a risk management strategy in several elds. At the international level, the precautionary principle was rst recognized in the World Charter for Nature produced by the UN General Assembly in 1982. In the European Union (EU), EC Regulation 1829/ 2003 on GM food and feed provides the legal basis for the approval procedure for GMOs as specied in the General Food Law. The safety of foods derived from GMOs is assessed by the Scientic Panel on Genetically Modied Organisms of the European Food Safety Agency (EFSA). It is for testing food safety, and environmental and animal health aspects of GMOs (one doorone key). The overall risk assessment should consist of the following points: I. Information of parent crop 1. Identity, and phenotypic and agronomic performance 2. Geographical distribution/source 3. History of safe use 4. Compositional analysis 5. Nutrients, anti-nutrients, toxins, and allergens II. Information of the donor, transgene, and delivery process 1. Description of the donor 2. Description of vector DNA 3. Transgene delivery 4. Characterization of introduced DNA sequences 5. Characterization of insertion site III. Information on the gene products: recombinant proteins and metabolites 1. Characterization of proteins and metabolites 2. Mode of action and target specicity 3. Assessment of toxicity 4. Assessment of allergenicity

IV. Information of the whole crop 1. Identity, and phenotypic and agronomic analysis 2. Compositional analysis 3. Safety and nutritional analysis and the use of animal test methods V. Exposure assessment 1. Data sources used to estimate food consumption 2. Evaluation of exposure to a new altered level of a food consumption The key information from each food safety protocols are the following: Hazard identication is the determination of whether a substance, such as a constituent in food, is or is not causally linked to particular health effects. Doseresponse evaluation is the determination of the relationship between the magnitude of exposure and the probability of occurrence of the adverse effect under study. Doseresponse assessment is the mechanism used to assess the potency or severity of the hazard in question. Exposure assessment is the determination of the extent of exposure to a toxicant under a particular set of exposure circumstances. Exposure assessment includes the determination of the magnitude of the exposure, the frequency of the exposure, and the duration of the exposure. Risk characterization considers these rst three factors and is often reported as a quantitative assessment of the probability of an adverse effect under dened exposure conditions. The effects of GMOs on human health and the environment are of two kinds: Direct effects refer to primary impacts on human health or the environment, which are a result of the

GMO itself and which do not occur through a causal chain of events. Indirect effects refer to primary impacts on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management. Time frame impacts can be due to various reasons: Immediate impacts on human health or the environment are observed during the period of consumption of the GMO or immediately after that. Delayed impacts are effects on human health or the environment that may not be observed during the period of the release of the GMO, but become apparent as a direct or indirect effect either at a later stage or after termination of the release.

GMO Benets and Adverse Effects

GM foods provoke many ethical debates among scientists and people in general about new technology that enables

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Table 2

Genetically Modied Organisms (GMOs)

Listing of main open issues regarding benets and adverse effects connected with GMOs Benets Resistance of insects, illness, herbicides Adverse effects Potential transfer of GMO genetic material to other plants and appearance of super plants that are resistant to pesticides Disadvantages of GMOs in food

Main open issues Agriculture/environment

Food processing

Nutrition and health

Reduction of pesticide usage Better sensory characteristics Quality Longer lifetime Higher nutritional value Bananas with HBV vaccine Tobacco that can produce human hemoglobin

Presence of allergens Unknown effect on other organisms

to create new forms of plant and animal life that otherwise would not exist (Table 2). From human history, it is obvious that agricultural crops have been genetically modied in the past. People always strive to get as much as possible from nature. To increase yields in agriculture and support people to improve their nutrition, the methods of selective breeding and crossbreeding of plants were used. Crosses between separate species were made mostly as a result of planned human action and occasionally by unpredictable natural processes that cannot be controlled. World global changes have inuence on agriculture and economic development. Today many food crops are unable to propagate or survive without human intervention. Biotechnology, environmental science, and social sciences are important tools for studying the worlds growing population. It is estimated that total world population is increasing rapidly and will be over 9 billion by 2050. This raises the question of providing enough food to developing and developed countries. GM food technology, as a modern biotechnology technique, has the potential to deliver a new dimension of food safety and quality. Advances in modern biotechnology can be linked to environmental and health issues. More sustainable agricultural practices with reduced use of chemical pesticides, fertilisers, and drugs can be expected. The positive aspects of biotechnology can also result in health care benets, allowing for the production of cheaper, safer drugs in large quantities. Personalized and preventive medicines based on genetic predisposition, targeted screening, and innovative drug treatments are among the possibilities on offer. A multidisciplinary and innovative approach is required in discussing a eld that provides quick and effective responses to maintain health and safe environment that has additional advantages in the food supply chain with consumer in the end. With these aspects the need for responsible policies at EU and international levels are highlighted to ensure the protection of the environment and human health as a priority at all times. This would involve acknowledging the importance of the subjective comprehension of health and safety concepts, which is a component of well-being.

GMO Benets and Adverse Effects on Biodiversity Agriculture is a primary human activity and is directly connected with environment. Agriculture is widely determined by the environment and the two are intertwined both healingly and destructively. Human activities are burdening for the environment and thus can inuence human health through food chain. A nancial perspective of the EU policy aims at more focus on general requirement assurance (food safety, food quality, product diversity) and added value (animal welfare, environment, and health protection) to achieve a higher quality of life (Table 3). It is distinctive for current agriculture to aim at environmentally friendly agricultural practices, which preserve and improve environment and at the same time assure quality and safety of agricultural products, because of the concern for consumers and agricultural activity. In plant production and in the entire agricultural sector, the production system is connected with the environment through strong and complex relationships: improvement of corn hybrids and certain short-stalk rice and wheat species gave excellent results in connection with soaking and fertilizing as long as they were protected against pest and diseases by pesticides. Researches in this eld have shown harmful impact on human and animal health, mainly because of their genotoxic and mutagenic activity. Lately, there have been more and more researches and technical and scientic discussions regarding GMO use in agriculture. The majority of concerns are caused due to GMOs impact on the environment and human health and their short history of use. GMOs are globally not something new, because they have been present since 1970, but they have been used widely for a little more than a decade, mainly in America, Canada, and Argentina. There is danger of so-called genetic pollution and formation of so-called super weed.A question of resistance against pesticides and other harmful impacts on the biotopes is arising as well. All this intensication has not left out the animal production either (e.g., bovine spongiform

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Table 3 Objectives for developing GM crops Quality issues Sensory properties improvement Enhanced nutritional value Health issues

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Agronomic issues Herbicide tolerance Insect resistance Resistance to viruses, fungi, and bacteria Drought resistance Salinity resistance Effects of metals

Male sterility/fertility restoration Malnutrition in developing countries Disease resistance

encephalopathy (BSE)). Some actions, changes, or encroachment of the nature can have serious consequences, which is proved by media response to recent incidences in food supply chain. This is the reason why the best possible mutual impact based on given circumstances between agriculture and the environment must be achieved. Agricultural activities (food, plant production, cultivation, watering, etc.) must be performed in accordance with the rules, which stimulate production of quality and safe products on one hand and the best possible environmental management on the other. Biodiversity is the complex of two main components. The rst is the variation and number of life forms within a given ecosystem or biome or for the entire earth; the second is a measure of the diversity within a species or genetic diversity. The term biodiversity is used also as a measure of the health of biologic systems. If biodiversity is seen from the natural perspective, it is normal that gene transmission is constantly occurring within the environment. It depends on the crop, the modication, the environment, and the way people respond to it. Cross-pollination and possibly many other unknown processes integrate segments of DNA from one organism into the genome of another organism. This can occur between organisms of the same species or between organisms of different species. The difference between traditional agriculture and GM crops is in the biodiversity of cultures. In the traditional agriculture similar individuals form a monoculture that contains little genetic diversity. In GM crops all the individuals within the species are genetically identical because they all have originated from one GM source of plant. Owing to all possible GMO risks for human population and the environment, the stress is laid on the precautionary principle. According to this fact, the main issue of the directive is to approximate the laws, regulations, and administrative provisions of the member states and to protect human health and the environment when carrying out the deliberate release into the environment of GMOs for any other purposes than placing on the market GMO as or in products within the community. In the EU the Commission is introducing an action plan with objectives to halt the decline of biodiversity and measures enabling these objectives to be achieved by

2010. The action plan is based on an assessment of biodiversity loss in the EU and globally and the measures taken by the EU to deal with the problem to date. The action plan stipulates priority objectives, which are divided into four policy areas (biodiversity in the EU, the EU and global biodiversity, biodiversity and climate change, and the knowledge base). It further species four main supporting measures (nancing, decision-making, building partnerships, and public education, awareness, and participation), as well as monitoring, evaluation, and review measures. The action plan is aimed at both the EU and the member states. The relevant measures will have to be taken by 2010 and will be continued beyond. GMO Benets and Adverse Effects on Human Health There are many debates among scientists and experts regarding GMO benets and adverse effects on human health. Opponents of GM foods claim that the long-term effects of GM foods on human health remain unknown because these products have not been adequately tested. In the United States, where GM foods have been used over a long period of time, no signicant human health problems have been seen to have emerged. But with new technology there are always some undesirable as well as benecial effects. Potential problems that might arise due to GM foods are related to: a. possibilities of introducing new toxins or allergens into previously safe foods; b. an increase in toxins to dangerous levels in foods; c. reduction in nutritional value of foods. Allergic reactions caused by GM products in human beings are not yet exactly known; hence it is difcult to predict harmful effects of GM foods on human health. It has been suggested that an unidentied toxic substance would be more likely to appear in a conventional newvariety crop, where many new genes are routinely introduced, rather than in a GM plant containing a single characterized gene and its protein products. Some scientists claim that the potential effects of the introduction of a single gene in a GMO are more predictable than the effects in a new-variety crop produced by conventional selection methods. Even in conventional crop lines,

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of the many produced, only two have shown the environmental induction of a toxic compound that had not been detected during routine testing. It was found that one of these (psoralen), which had accumulated in insect-resistant non-GM celery in response to light, causes skin burns. Toxic accumulations of solanine, induced by cold weather, caused the withdrawal of the non-GM Magnum Bonum potato line in Sweden (http://dsp-psd.pwgsc.gc.ca/Collection-R/LoPBdP/BP/ prb9912-e.htm#%2818%29). The concept of substantial equivalence, used by regulatory authorities, has also been criticized. The concept was not exactly dened, and scientists are not yet able to predict reliably the biochemical or toxicological effects of a GM food from knowledge of its chemical composition. Others believe that substantial equivalence is a useful tool that identies differences between a GM crop and a non-GM crop so that they can be further scrutinized. In spite of the many proponents of GMOs who argue that there is currently no evidence that GM foods pose a greater risk than traditional foods, opponents point to the lessons of the mad cow disease crisis in Europe: just because there is no proof that a food product poses a risk does not necessarily mean that it is safe. The best that science can do is to dispel some of the uncertainty on both sides of this issue (http://dsp-psd.pwgsc.gc.ca/Collection-R/LoPBdP/BP/ prb9912-e.htm#%2818%29).

cultivated plants, and promoting appropriate control measures. This also applies to risks associated with LMOs. EU Legislation The EU legislation about GMOs is very abundant and restrictive: Directive 90/219/ECC about contained use of GM microorganisms governed measures for limited use of GM microbes, measures for avoidance of adverse effects on human health and environment, and emergency plan in case of an accident and regular inspections. It amends Directive EU 98/81/EC. Directive 90/220/EEC governed experimental releases and marketing authorization of all GMOs. The directive set out an approval process requiring the case-by-case assessment of the potential risks to human and animal health and environment due to all GMOs (except for pharmaceuticals which are regulated separately). The directive was revised to draw strength on the existing requirements for risk assessment and the decisionmaking process. Revised Directive 2001/18/EC on the deliberate release of GMOs introduces mandatory labeling and traceability. Regulation 1829/2003/EC on GM food and feed provides the legal basis for the approval procedure for GMOs as specied in the General Food Law. The safety of foods is assessed by the EFSA. Regulation 1830/2003 governs traceability and labeling of GMOs and food and feed product from GMOs. Directive EU 2004/204/EC about arrangements for the operation of the registers for recording information on genetic modications in GMOs provides the legal basis to the list of information on genetic modication in GMOs, which should be available to the public. Directive EU 2004/643/EC governs equivalence principle. The GMOs should be as safe as conventional. Placing on the market of a maize product (Zea mays L. line NK603) GM for glyphosate tolerance (handling, packaging, and protection) as conventional, obligatory recordation of the code measures for labeling and traceability in all stages of the market promotion. Directive EU 2004/657/EC governs that product should be as safe as conventional. It replaced Directive EU 90/ 220/EC. Regulation (EC) 258/97 governs novel food and novel food ingredients. It is about placing foods and food ingredients on the market that have not been used for human consumption to a signicant degree within the community before. It also governs specic requirements for labeling and specic procedure for foodstuffs containing GMOs. Regulation (EC) 1139/98 governs the compulsory indication of the labeling of certain foodstuffs produced from

Regulatory Issues on GMO

There are several important international mechanisms in the context of GMOs: The Cartagena Protocol to the Convention on Biological Diversity was adopted in January 2000. It covers the transboundary movement, transit, handling, and use of all LMOs (except pharmaceuticals) that may have adverse effects on the conservation and sustainable use of biological diversity, also taking into account risks to human health. It allows for standard setting in relation to the handling, transport, packaging, and identication of LMOs. The food safety aspects of GMOs are, at international level, dealt with by the FAO/WHO Codex Alimentarius Commission, which covers all aspects of food safety. The Codex is currently working on standards for risk assessment for labeling, and for several other food safety aspects of GMOs. The Codex standards are recognized by the SPS and TLC Agreements. The International Plant Protection Convention (IPPC) has the objective of preventing the spread and introduction of plant and plant product pests, including weeds and other species that have indirect effects on both wild and

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GMOs. It is applied to food and food ingredients that are produced from GM soybean or GM corn. It replaces Regulation (EC) No. 1813/97 and amends Regulations 1813/97, 49/2000, and 50/2000. Regulation (EC) 65/2004 gives legal basis for unique identier for each GMO that is placed on the market. Regulation (EC) 641/2004 relates to the authorization of new GM food and feed, the notication of existing products, and transitional measures for adventitious or technically unavoidable presence of GM material that has beneted from a favorable risk evaluation. In the EU the EFSA reviews the risk assessment submitted by applicants interesting in placing a novel food on the EU market. US Legislation The US regulatory framework for GM crops was laid out in the 1986 Coordinated Framework for Regulation of Biotechnology (Table 4). This is a product-based regulatory framework for GM crops and derived foods. Three principal regulatory agencies conduct science-based assessments of risks to human health and the environment: the US Department of Agriculture (USDA), the EPA, and the FDA. The USDA regulates import, interstate movement, eld trial release, and commercial release of GM crops. The EPA has regulatory oversight for all GM crops that produce plant pesticides. The FDA has authority over human food and animal feed safety and the wholesomeness of all plant products, including those produced via GM.

Traceability of GMOs
GMOs and food or feed produced from GMOs can be present on the EU market, if it had been approved by EU competent bodies. Approval is based on scientic estimation of hazards for humans, animals, and the environment. The process of approving GMOs and products made of GMOs includes protection of consumer interests (the GM product must be suitably labeled to enable the consumer a possibility of choice). A large number of GMOs are already being used in the plant production. The most common GM plants are
Table 4 Title Genetically Engineered Food Safety Act, 2003 Genetically Engineered Crop and Animal Farmer Protection Act, 2003 Genetically Engineered Food Right to Know Act, 2003 Genetically Engineered Pharmaceutical and Industrial Crop Safety Act, 2003 US acts for GMO

soy, corn, cotton, and rapeseed. All these industrial plants gained resistance against certain insects or tolerance to certain herbicides, or even both by genetic modications. Only GM corn, labeled MON 810, which is resistant to insects, is authorized in the EU so far. European legislation on GMOs is mainly designed to protect human and animal health and environment, but in the EU it assures free movement of approved GMOs and products produced from GMOs at the same time. European legislation manages the contained use of GM microorganisms (Directive 90/219/ECC), the deliberate release of GMOs into the environment (Directive 2001/18/EC), and regulations concerning the traceability and labeling of GMOs and food and feed products produced from GMOs (1829/03/EC in 1830/ 03/EC), which is directly applied in all EU member states (Table 5). Application procedure for approval of a new GMO is separately regulated in Directive 2001/18/EC and Regulation 1829/2003/EC. In case of application concerning GM food or feed, it is regulated by Regulation 1829/2003/EC only, but requirements regarding environment protection stated in Directive 2001/18 EC must be met. Hazard analysis for separate GMOs is done by the EFSA. Before approval, opinions of the Commission and member states must be considered rst. The approved GMOs are included in the register of GM food and feed, also available on http://ec.europa.eu/food/dyna/gm_ register/index_en.cfm. Approval of a separate GMO in accordance with Regulation 1829/2003/EC is valid for 10 years, and for GMOs, which were approved according to some other legislation, the approval is valid for 39 years. Traceability and labeling of GMOs are determined in Regulation 1829/2003/ES on GM food and feed, Regulation 1830/2003/EC concerning the traceability and labeling of GMOs and food and feed products produced from GMOs, and the amendment of Directive 2001/18/ EC. Approved GMOs and food and feed produced from GMOs, which are present on the EU market, must be suitably labeled and their traceability must be assured. Traceability means the ability to trace GMOs and GMO products at all stages of their placing on the

Main points Denitions of GMO, determination of safety, regulation of food additives Denitions of GMO, contract limitations regarding sale of GM crops, prohibition on labeling seeds as nongenetically engineered, prohibition on certain nonfertile plant seeds Requirements for labeling regarding GM material Alternative methods to produce pharmaceutical and industrial crops, pharmaceutical crop denitions

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Table 5

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Methods for tracing and tracking of GMOs Title Determination of 35S promotor by PCR Determination of NOS terminator by real-time PCR Determination of NOS terminator by PCR Determination of CaMV virus by real-time PCR Determination of 35S:BAR by real-time PCR Determination of 35S promoter by real-time PCR Quantication of soya MON-432-6 (RRS) by realtime PCR Quantication of Bt 176 maize by real-time PCR Quantication of T-25 maize by real-time PCR Quantication of Bt 11 maize by real-time PCR Quantication of MON 810 maize by real-time PCR Quantication of GA 21 maize by real-time PCR Quantication of MON 863 maize by real-time PCR Quantication of NK 603 maize by real-time PCR Quantication of RT73 maize by real-time PCR Quantication of TC 1507 maize by real-time PCR Determination of rice LL601 by real-time PCR Determination of rice LL62 by real-time PCR Determination of H7-1 sugar beet by real-time PCR Quantication of DAS-59122-7 maize by real-time PCR Quantication of potato EH92-527-1 by real-time PCR Quantication of lectin gene by real-time PCR Quantication of invertase gene by real-time PCR Determination of zein by PCR Determination of lectin by PCR Determination of metal carboxypeptidase inhibitor by real-time PCR Determination of metal carboxypeptidase inhibitor of potato by real-time PCR Quantitative determination of phosphoenolpyruvate carboxylase by real-time PCR Determination of phospholipase D (rice) gene by realtime PCR Quantication of glutamine synthetase (sugar beet) gene by real-time PCR Type of analysis (qualitative/quantitative) Qualitative

Field of analysis Detection of screening elements

Determination of specic genetic elements

Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative LOD 12 copies LOQ 10 copies Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative Qualitative Qualitative Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative and quantitative Qualitative Qualitative Qualitative Qualitative Qualitative and quantitative Qualitative Qualitative and quantitative

Determination of reference genes

market, through the production and distribution chains. Anybody who sells GM products (products containing GMOs or products produced from GMOs) must update consumers with specic information on GMOs. Special identication marks are designated for each GMO to make traceability assurance easier. Traceability is used to check unsuitable labeling and for tracing and surveillance of potential impact on health and environment. Suitable traceability enables GMO recall from the market in case of subsequent determination of its harmful effects. Food or feed, containing more than 0.9% GMOs in each separate compound, provided that the presence of GMOs is unintentional or technically unavoidable, must be suitably labeled. Labeling is regulated by the abovementioned legislation. Labeling of GMOs is strictly regulated in most of the countries in the world, but many countries do not demand it. Researches of public opinion

have showed that in the EU, only a quarter of the population is willing to consume GMOs; this is why it is important to enable a possibility of choice to every consumer. In the EU, labeling of food and feed containing GMOs has been obligatory for several years now. Consumers can make a choice and decide to choose products produced from GMOs. There are still only few foodstuffs labeled as GMOcontaining in thee EU market, but there is plenty of feed labeled as GMO-containing. The production of GM plants is differently regulated in countries across the world. In some countries there are strict rules, but not in others. As there is a possibility of mixing between GM and non-GM plants on the elds and during transportation, especially by pollen, some of the EU countries had to develop conditions of coexistence of traditional and GM production. Ecological

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farming is specially stressed upon. The EU countries adopted different rules, but they must be approved at the EU level. Measures include safety distances between elds, additional area between elds, which prevents movement of pollen, and compensation of damage refunds in cases of economic loss.

Public Opinion on GMO

In Europe the rst major discussion on gene technology was in the late eighties, when GM food was not yet commercialized and only separate applications were used in the industry. At rst there were sporadic reactions within national legislations, which were later harmonized in the EU countries. First reactions to the rst European directives calmed conicts regarding gene technology. There were fewer debates on GMOs. Disputes were less intensive. But the calmness was only temporary. In 1996, the second major international dispute arose due to the presence of GM soybeans in the European harbors. GM soybeans were much more resistant to herbicides. This was followed by other applications of biotechnology in different scientic elds. The result was growing public interest in bizarre phenomenon, especially GMOs in food. Public debates have caused an increase in the number of nongovernmental organizations and in demands for involvement of society in general in these debates, formation of legislation, scientic strategies, and also importance of a consumer, who either approved or disapproved genetic modication of products by buying or by boycotting such products. Identication of a hazard can be displayed as a special behavior against a special object representing a potential hazard. In other words, it means that when people perceive there is a hazard present, they respond with a reaction. So, public resentment against GMOs is related to the opinion that even small-scale use of GMOs is forced and uncontrolled. To understand human behavior it is important to know public opinion regarding science and technology because some of the social groups have values that oppose globalization, for example, of wholeness of nature and the like. It is obvious that various types of behavior, which appear not to be connected, inuence public opinion and shopping habits. In democratic societies, where choice is possible, people do not buy food with the negative connotation. There are several reasons for such second thoughts: an opinion about negative inuences on the environment, agricultural tradition, and hazards connected with public or animal health. In research of public opinion the ethical reasons must not be ignored. Messing with nature, unintentional inuences are unpredictable, so they were not yet discovered by science, and the like are mentioned. The public reacts to technological innovations in such a

way due to a fear that technology will inuence a social structure and relation between its parts. Researches specially stressed on the understanding of negative public attitude toward GMOs in food. This negativism was particularly expressed around 1990 much to the surprise of legislative authorities, science, and industry. Public opinion moves from more to less concrete worries: unintentional effects such as allergies, crossbreeding between unrelated species of plants and animals, super plant phenomenon, and worries related to uncertainness, unintentional effects on humans and the environment, as well as potential negative irreversible effects. Qualitative and quantitative approaches discovered some details regarding moral issues connected with GMOs, like unnaturalness, messing with nature, animal welfare, balance between industry and consumers, democracy, differences between developed countries and the third world, and the like. The range of public concern regarding GMO eld of application is unusually constant. Some of the concerns are intrinsic, mainly in the eld of technology, whereas others are related with second thoughts on risks. In a comparison of consumers opinion in Europe and the United States, it was determined that US consumers are more perceptive about GM food than European consumers. The reason is based on three factors: inuence of the media, trust in surveillance, and knowledge of biology and genetics. Technological disputes are much more covered by the media in Europe than in America, which has a certain impact on consumers. Individuals in America trust surveillance authorities as they do in Europe. Europeans are supposed to demand more information about GMOs than Americans, and if the latest incidents in the food industry are added, it is understandable that Europe is more skeptical than America. People have different opinions regarding GMOs. Some encourage it; some strongly oppose. But regardless of the consumers opinion GMOs have both useful and harmful effects in many areas.
See also: Entomological Risks of Genetically Engineered Crops, Labelling of Genetically Modied Foods.

Further Reading
Arvanitoyannis IS, Choreftaki S, and Tserkezou P (2006) Presentation and comments on EU legislation related to food industriesenvironment interactions: Sustainable development, and protection of nature and biodiversity Genetically modied organisms. International Journal of Food Science and Technology 41: 813--832. Banati D and Lanker Z (2003) Modern biotechnology and the Hungarian consumers. Acta Alimentaria 32: 5--23. no FC (2008) Simulation and evaluation of GM and non-GM Colo segregation management strategies among European grain merchants. Journal of Food Engineering 88: 306--314.

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Dezider T (2007) Genetically modied organisms and food safety. In: McElhatton A and Marshall RJ (eds.) Food Safety: A Practical and Case Study Approach, pp. 122--133. New York: Springer Science Business Media, LLC. Engel KH, Frenzel Th, and Miller A (2002) Current and future benets from the use of GM technology in food production. Toxicology Letters 127: 329--336. Fewer L, Lassen J, Kettlitz B, et al. (2004) Societal aspects of genetically modied foods. Food and Chemical Toxicology 42: 1181--1193. Gaskell G, Allandsdottir A, and Allum N (2006) Europeans and Biotechnology in 2005: Patterns and Trends, Eurobarometer 64.3 A Report to the European Commissions Directorate-General for Research. Brussels: European Commission.

OFallon MJ, Gusory D, and Swanger N (2007) To buy or not to buy: Impact of labeling on purchasing intentions of genetically modied foods. Hospitality Management 26: 117--130. Plahuta P and Raspor P (2007) Comparison of hazards: Current vs. GMO wine. Food Control 18: 492--502. Rizzi A, Sorlini C, Mannino S, and Daffonchio D (2007) Ensuring biosafety through monitoring of GMO in food with modern analytical techniques, a case study. In: McElhatton A and Marshall RJ (eds.) Food Safety: A Practical and Case Study Approach, pp. 281--294. New York: Springer Science Business Media, LLC. Varzakas TH, Arvanitoyannis IS, and Baltas H (2007) The politics and science behind GMO acceptance. Critical Reviews in Food Science and Nutrition 47: 335--361.