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Biosafety of Food from Genetically Modifi ed Crops 445 TABLE 15.1 Assessment of Biosafety of Food Derived from Transgenic Crops Effects General/Specifi c Tests Human health assessment Mammalian toxicity Digestibility Allergenicity Homology with known food allergens Food safety assessment Composition Nutritional quality Substantial equivalence Animal feed value Unanticipated effects Nonfood safety Occupational health effects and environmental contamination (via pollen, water, etc.) Source: Cockburn, A. (2002). Journal of Biotechnology 98: 79–106. A rigorous safety-testing paradigm has been developed for transgenic crops, which utilizes a systematic, stepwise, and holistic approach. The resultant science-based process focuses on a classical evaluation of the toxic potential of the novel trait introduced and the wholesomeness of the transformed crop. In addition, detailed consideration should be given to the history and safe use of the parent crop as well as that of the transgene product. Despite application of rigorous procedures, there is no evidence of harm resulting from the consumption of food derived from transgenic crops. Direct and indirect health effects of genetically modifi ed foods should be used as a guideline for safety assessment, including the tendency to provoke allergic reactions, specifi c components thought to have nutritional or toxic properties, stability of the inserted gene, and nutritional effects that could result from gene insertion (Haslberger, 2003). Several studies have focused on understanding the intended alterations in composition of food crops that may occur as a result of genetic modifi cation (Kuiper, Kok, and Engel, 2003). The available information on biological effects, Phase 1 Phase 2 Gene transfer Biosafety Assessment of Food from Transgenic Crops Principle of Substantial Equivalence (Analysis of the differences between the transgenic and the traditional counterpart) Toxicological and Nutritional Evaluation Allergenicity Degradation Bio- availability Phase 3 Final Safety Assessment of Food from Transgenic Crops FIGURE 15.1 Biosafety assessment of food from genetically modifi ed crops. Toxicity Food intake and biological effects
446 Biotechnological Approaches for Pest Management and Ecological Sustainability nutritional quality, and chemical composition of food derived from genetically modifi ed crops is discussed in the following pages. Comparative Effects of Traditional Breeding and Genetic Engineering on Food Quality There is a need for the new technologies to be tested rigorously for potential allergenic, toxic, and antimetabolic effects in a transparent manner (Gillard, Flynn, and Rowell, 1999). In the context of food safety, it is useful to consider the genetic consequences of plant breeding approaches that provide the opportunity to introduce or modify a plant trait. Conventional plant breeding may also cause rearrangements of the genome and result in production of previously unknown toxins, antinutrients, or allergens. Examples, though uncommon, include insect-resistant celery, which accumulates psoralen in response to light and thereby causes skin burns (Ames and Gold, 1999), and the Magnum Bonum potato, which accumulates toxic levels of solanine in cool weather (Van Gelder, Vinke, and Scheffer, 1988). This raises the question of whether the same safety assessment criteria should be applied to conventionally modifi ed foods as to genetically modifi ed foods. In tomato, it has been possible to evaluate the precision of the genetic change in relation to the size and position of introduced DNA, whereby a trait that modifi es carbohydrate composition was introgressed from a wild tomato or engineered by the introduction of an antisense transgene into the cultivated tomato. The results indicated that both classical and molecular approaches introduce a degree of uncertainty in the fi nal genetic makeup, but the source of this uncertainty is quite different in each case (Bennett, Chetelat, and Klann, 1995), and, therefore, it is reasonable to assume that analysis of the safety of genetically engineered food products be evaluated relative to that of traditional approaches that achieve the same goal. Substantial Equivalence to the Nontransgenic Food The overall safety evaluation is conducted under the concept known as “substantial equivalence,” which is enshrined in all international crop biotechnology guidelines. This provides the framework for a comparative approach to identify the similarities and differences between the transgene product and its comparator, which has a known history of safe use. By building a detailed profi le on each step in the transformation process, from parent to new crop, and by thoroughly evaluating the signifi cance of change from a safety perspective of any differences that may be detected, a comprehensive matrix of information is constructed to enable decision making as to whether the food or feed derived from a transgenic crop is as safe as its traditional counterpart. Using this approach, more than 100 transgenic crops have been approved worldwide based on the conclusion that foods and feeds derived from genetically modifi ed crops are as safe and nutritious as those derived from traditional crops (Cockburn, 2002). Substantial equivalence is based on the principle that if genetically modifi ed food can be shown to be equivalent in composition to an existing food, then it can be considered as safe as its conventional equivalent. Composition and nutritional values of many crops will depend, among other things, on growth conditions, climate, and time of harvesting. Toxicological testing of whole foods has limitations due to bulkiness (diffi culties in ingesting suffi cient quantities of the whole food in the diet) as compared to food additives or medicines. However, application of such tests to conventional crops with a “history of safe use” may defi ne them as unsafe. In recognition of these diffi culties, the principle of substantial
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BIOTECHNOLOGICAL APPROACHES FOR PES
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CRC Press Taylor & Francis Group 60
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vi Contents Population Prediction M
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viii Contents Multilines/Synthetics
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x Contents 7. Genetic Transformatio
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xii Contents Horizontal Gene Flow .
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xiv Contents Cereals ..............
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xvi Contents Expressed Sequence Tag
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xviii Foreword Large-scale deployme
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xx Preface of newer insecticide mol
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2 Biotechnological Approaches for P
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10 Biotechnological Approaches for
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7 Genetic Transformation of Crops f
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Genetic Transformation of Crops for
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8 Genetic Engineering of Entomopath
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Genetic Engineering of Entomopathog
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9 Genetic Engineering of Natural En
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11 Transgenic Resistance to Insects
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Transgenic Resistance to Insects: I
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19 Biotechnology, Pest Management,
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Biotechnology, Pest Management, and
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514 Species Index Arabidopsis thali
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516 Species Index Empoasca fabae HP
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518 Species Index N Nasonovia ribis
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520 Species Index Sorghum (continue
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522 Subject Index Brown planthopper
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524 Subject Index Mass rearing, 4,
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526 Subject Index Toxin genes for i
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