Positeve - Genetically Modified Organisms

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<ul><li><p>7/27/2019 Positeve - Genetically Modified Organisms</p><p> 1/10</p><p>Genetically Modified Organisms (GMOs)</p><p>R Peter and J Mojca, University of Ljubljana, Ljubljana, Slovenia</p><p>P Primoz, Zalog, Postojna, Slovenia</p><p>&amp; 2011 Elsevier B.V. All rights reserved.</p><p>Abbreviations</p><p>BSE bovine spongiform encephalopathy</p><p>EFSA European Food Safety Agency</p><p>EPA Environmental Protection Agency</p><p>EU European Union</p><p>FDA US Food and Drug Administration</p><p>GM genetically modified</p><p>GMO genetically modified organism</p><p>IPPC International Plant Protection Convention</p><p>LMO living modified organism</p><p>OECD Organisation for Economic Co-operation</p><p>and Development</p><p>USDA US Department of Agriculture</p><p>Introduction</p><p>Directive 2001/18/EC of the European Parliament and</p><p>of the Council on the deliberate release of genetically</p><p>modified organisms (GMOs) into the environment de-</p><p>fines a GMO as an organism, with the exception of the</p><p>human being, in which the genetic material has been</p><p>altered in a way that does not occur naturally by mating</p><p>or by natural recombination.</p><p>Natural recombination is a technique using re-</p><p>combinant nucleic acids, which also include new genetic</p><p>material by adding nucleic acid molecules. Molecules can</p><p>be formed outside the organism, for example, with the</p><p>help of virus, bacterial plasmid, or other vector in a host</p><p>organism. Vector does not harm the host organism, but is</p><p>successfully multiplied in it. This is a method involving</p><p>the direct introduction of heritable material, formed</p><p>outside the organism, including microinjection, macro-</p><p>injection, and microencapsulation. It is a cell fusion or</p><p>cell hybridization technique, in which live cells with new</p><p>combinations of heritable genetic materials are formedthrough the fusion of two or more cells by methods that</p><p>do not occur naturally.</p><p>From the Cartagena Protocol on Biosafety to the</p><p>Convention on Biological Diversity, a new term living</p><p>modified organisms (LMOs) is used instead of GMO. It</p><p>stands for living modified organisms that have been</p><p>genetically modified through the application of modern</p><p>biotechnology.</p><p>Modern biotechnology includes nucleic acid tech-</p><p>niques in vitro, including recombinant DNA, direct</p><p>injection of nucleic acids into cells or organelles, and cellmerging above their taxonomic category, which reaches</p><p>above natural physiological reproductive barriers and</p><p>techniques, which are not used in traditional multipli-</p><p>cation and selection.</p><p>GMOs have already entered the food chain in most</p><p>parts of the world. Many microorganisms, mainly bac-</p><p>teria, have been modified to increase the production</p><p>of proteins, amino acids, and commercial chemicals.</p><p>Pioneer works with GMOs are related to the discovery</p><p>of a natural phenomenon mutagenesis, which helped to</p><p>develop different kinds of microorganisms. These mutants</p><p>were the first scientific tools in this field, but represented acommercial profit for the fermentation industry at the</p><p>same time. Plants were the first generation of micro-</p><p>organisms, but were available only in few markets.</p><p>The GMO market has been released by the devel-</p><p>opment of science and genetic information of a wide</p><p>range of organisms. A consequential expansion has</p><p>caused increased concern over genetic engineering use in</p><p>food industry and eventual harmful impacts on human</p><p>health and environment.</p><p>State of the Art in GMO Research and</p><p>Development</p><p>The creation of the first recombinant bacteria was in</p><p>1973, that is, Escherichia coliexpressing a Salmonellagene.</p><p>Herbert Boyer then founded the first company to use</p><p>recombinant DNA technology, Genentech, and in 1978,</p><p>the company announced the creation of an E. coli strain</p><p>producing the human protein insulin. In 1986, field tests</p><p>were conducted of bacteria genetically engineered to</p><p>protect plants from frost damage at a small biotechnology</p><p>company called Advanced Genetic Sciences. In the</p><p>same year, Monsantos proposed field test of a microbe</p><p>genetically engineered for a pest resistance protein was</p><p>dropped.</p><p>Status of GMOs in Agriculture and Food</p><p>Production</p><p>The first commercially grown genetically modified (GM)</p><p>food crop was a tomato created by Calgene called the</p><p>FlavrSavr. Calgene submitted it to the US Food and Drug</p><p>Administration (FDA) for testing in 1992, following the</p><p>FDAs determination that this transgene was actually a</p><p>tomato, did not constitute a health hazard, and did not</p><p>879</p></li><li><p>7/27/2019 Positeve - Genetically Modified Organisms</p><p> 2/10</p></li><li><p>7/27/2019 Positeve - Genetically Modified Organisms</p><p> 3/10</p><p>At the end of the 1980s the food safety assessment of</p><p>genetically engineered foods was for the first time discussed</p><p>at the international level. The point of the safety assess-</p><p>ment should be to determine whether the modified food is</p><p>as safe as its traditional counterpart. In these discussions</p><p>the concept of substantial equivalence was introduced as a</p><p>means of establishing a benchmark definition of safe food.</p><p>This concept was introduced by the Organization forEconomic Co-operation and Development (OECD)</p><p>Group of National Experts on Safety in Biotechnology as</p><p>an approach to assessing the food safety of GMOs, and has</p><p>been further elaborated on by other groups. The de-</p><p>termination of substantial equivalence is not the point of a</p><p>safety assessment, but rather a practical approach that</p><p>guides the safety assessment process. When there are rea-</p><p>sonable grounds for concern that potential hazards may</p><p>affect the environment or human, animal, or plant health,</p><p>and when at the same time the available data precludes a</p><p>detailed risk evaluation, the precautionary principle has</p><p>been politically accepted as a risk management strategy inseveral fields. At the international level, the precautionary</p><p>principle was first recognized in the World Charter for</p><p>Nature produced by the UN General Assembly in 1982.</p><p>In the European Union (EU), EC Regulation 1829/</p><p>2003 on GM food and feed provides the legal basis for</p><p>the approval procedure for GMOs as specified in the</p><p>General Food Law. The safety of foods derived from</p><p>GMOs is assessed by the Scientific Panel on Genetically</p><p>Modified Organisms of the European Food Safety</p><p>Agency (EFSA). It is for testing food safety, and en-</p><p>vironmental and animal health aspects of GMOs (one</p><p>doorone key). The overall risk assessment should consist</p><p>of the following points:</p><p>I. Information of parent crop</p><p>1. Identity, and phenotypic and agronomic per-</p><p>formance</p><p>2. Geographical distribution/source</p><p>3. History of safe use</p><p>4. Compositional analysis</p><p>5. Nutrients, anti-nutrients, toxins, and allergens</p><p>II. Information of the donor, transgene, and delivery</p><p>process</p><p>1. Description of the donor</p><p>2. Description of vector DNA</p><p>3. Transgene delivery</p><p>4. Characterization of introduced DNA sequences</p><p>5. Characterization of insertion site</p><p>III. Information on the gene products: recombinant</p><p>proteins and metabolites</p><p>1. Characterization of proteins and metabolites</p><p>2. Mode of action and target specificity</p><p>3. Assessment of toxicity</p><p>4. Assessment of allergenicity</p><p>IV. Information of the whole crop</p><p>1. Identity, and phenotypic and agronomic analysis</p><p>2. Compositional analysis</p><p>3. Safety and nutritional analysis and the use of</p><p>animal test methods</p><p>V. Exposure assessment</p><p>1. Data sources used to estimate food consumption2. Evaluation of exposure to a new altered level of a</p><p>food consumption</p><p>The key information from each food safety protocols are</p><p>the following:</p><p>Hazard identificationis the determination of whether a</p><p>substance, such as a constituent in food, is or is not</p><p>causally linked to particular health effects.</p><p>Doseresponse evaluation is the determination of the</p><p>relationship between the magnitude of exposure and the</p><p>probability of occurrence of the adverse effect under</p><p>study. Doseresponse assessment is the mechanism used</p><p>to assess the potency or severity of the hazard in question.Exposure assessment is the determination of the extent</p><p>of exposure to a toxicant under a particular set of</p><p>exposure circumstances. Exposure assessment includes</p><p>the determination of the magnitude of the exposure,</p><p>the frequency of the exposure, and the duration of the</p><p>exposure.</p><p>Risk characterization considers these first three factors</p><p>and is often reported as a quantitative assessment of the</p><p>probability of an adverse effect under defined exposure</p><p>conditions. The effects of GMOs on human health and</p><p>the environment are of two kinds:</p><p> Direct effects refer to primary impacts on humanhealth or the environment, which are a result of theGMO itself and which do not occur through a causal</p><p>chain of events.</p><p> Indirect effects refer to primary impacts on humanhealth or the environment occurring through a causal</p><p>chain of events, through mechanisms such as inter-</p><p>actions with other organisms, transfer of genetic</p><p>material, or changes in use or management.</p><p>Time frame impacts can be due to various reasons:</p><p> Immediate impacts on human health or the environ-ment are observed during the period of consumption</p><p>of the GMO or immediately after that.</p><p> Delayed impacts are effects on human health or theenvironment that may not be observed during the</p><p>period of the release of the GMO, but become</p><p>apparent as a direct or indirect effect either at a later</p><p>stage or after termination of the release.</p><p>GMO Benefits and Adverse Effects</p><p>GM foods provoke many ethical debates among scientists</p><p>and people in general about new technology that enables</p><p>Genetically Modified Organisms (GMOs) 881</p></li><li><p>7/27/2019 Positeve - Genetically Modified Organisms</p><p> 4/10</p><p>to create new forms of plant and animal life that otherwise</p><p>would not exist (Table 2). From human history, it is ob-</p><p>vious that agricultural crops have been genetically modi-</p><p>fied in the past. People always strive to get as much as</p><p>possible from nature. To increase yields in agriculture and</p><p>support people to improve their nutrition, the methods of</p><p>selective breeding and crossbreeding of plants were used.Crosses between separate species were made mostly as a</p><p>result of planned human action and occasionally by un-</p><p>predictable natural processes that cannot be controlled.</p><p>World global changes have influence on agriculture</p><p>and economic development. Today many food crops are</p><p>unable to propagate or survive without human inter-</p><p>vention. Biotechnology, environmental science, and so-</p><p>cial sciences are important tools for studying the worlds</p><p>growing population. It is estimated that total world</p><p>population is increasing rapidly and will be over 9 billion</p><p>by 2050. This raises the question of providing enough</p><p>food to developing and developed countries. GM</p><p>food technology, as a modern biotechnology technique,</p><p>has the potential to deliver a new dimension of food</p><p>safety and quality. Advances in modern biotechnology</p><p>can be linked to environmental and health issues.</p><p>More sustainable agricultural practices with reduced use</p><p>of chemical pesticides, fertilisers, and drugs can be</p><p>expected. The positive aspects of biotechnology can</p><p>also result in health care benefits, allowing for the pro-</p><p>duction of cheaper, safer drugs in large quantities.</p><p>Personalized and preventive medicines based on genetic</p><p>predisposition, targeted screening, and innovative drug</p><p>treatments are among the possibilities on offer. A mul-</p><p>tidisciplinary and innovative approach is required indiscussing a field that provides quick and effective re-</p><p>sponses to maintain health and safe environment that has</p><p>additional advantages in the food supply chain with</p><p>consumer in the end. With these aspects the need for</p><p>responsible policies at EU and international levels are</p><p>highlighted to ensure the protection of the environment</p><p>and human health as a priority at all times. This would</p><p>involve acknowledging the importance of the subjective</p><p>comprehension of health and safety concepts, which is a</p><p>component of well-being.</p><p>GMO Benefits and Adverse Effects on</p><p>Biodiversity</p><p>Agriculture is a primary human activity and is directly</p><p>connected with environment. Agriculture is widely de-</p><p>termined by the environment and the two are inter-</p><p>twined both healingly and destructively. Human activitiesare burdening for the environment and thus can influ-</p><p>ence human health through food chain.</p><p>A financial perspective of the EU policy aims at more</p><p>focus on general requirement assurance (food safety, food</p><p>quality, product diversity) and added value (animal wel-</p><p>fare, environment, and health protection) to achieve a</p><p>higher quality of life (Table 3). It is distinctive for</p><p>current agriculture to aim at environmentally friendly</p><p>agricultural practices, which preserve and improve en-</p><p>vironment and at the same time assure quality and safety</p><p>of agricultural products, because of the concern for</p><p>consumers and agricultural activity.</p><p>In plant production and in the entire agricultural</p><p>sector, the production system is connected with the en-</p><p>vironment through strong and complex relationships:</p><p>improvement of corn hybrids and certain short-stalk rice</p><p>and wheat species gave excellent results in connection</p><p>with soaking and fertilizing as long as they were pro-</p><p>tected against pest and diseases by pesticides. Researches</p><p>in this field have shown harmful impact on human and</p><p>animal health, mainly because of their genotoxic and</p><p>mutagenic activity.</p><p>Lately, there have been more and more researches and</p><p>technical and scientific discussions regarding GMO use in</p><p>agriculture. The majority of concerns are caused due toGMOs impact on the environment and human health</p><p>and their short history of use. GMOs are globally not</p><p>something new, because they have been present since</p><p>1970, but they have been used widely for a little more</p><p>than a decade, mainly in America, Canada, and Argentina.</p><p>There is danger of so-called genetic pollution and for-</p><p>mation of so-called super weed.A question of resistance</p><p>against pesticides and other harmful impacts on the bio-</p><p>topes is arising as well. All this intensification has not left</p><p>out the animal production either (e.g., bovine spongiform</p><p>Table 2 Listing of main open issues regarding benefits and adverse effects connected with GMOs</p><p>Main open issues Benefits Adverse effects </p><p>Agriculture/environment Resistance of insects, illness, herbicides Potential transfer of GMO genetic material to</p><p>other plants and appearance of super plants</p><p>that are resistant to pesticides</p><p> Reduction of pesticide usage</p><p>Food processing Better sensory characteristics Disadvantages of GMOs in food</p><p> Quality Longer lifetime</p><p>Nutrition and health Higher nutritional value Presence of allergens</p><p> Bananas with HBV vaccine Unknown effect on other organisms</p><p> Tobacco that can produce human hemoglobin</p><p>882 Genetically Modified Organisms (GMOs)</p></li><li><p>7/27/2019 Positeve - Genetically Modified Organisms</p><p> 5/10</p></li><li><p>7/27/2019 Positeve - Genetically Modified Organisms</p><p> 6/10</p><p>of the many produced, only two have shown the en-</p><p>vironmental induction of a toxic compound that had not</p><p>been detected during routine testing. It was found</p><p>that one of these (psoralen), which had accumulated</p><p>in insect-resistant non-GM celery in response to</p><p>light, causes skin burns. Toxic accumulations of solanine,</p><p>induced by cold weather, caused the withdrawal of</p><p>the non-GM Magnum Bonum...</p></li></ul>