1、Genetically modified food safety issuesAbstractAs we all know,modern biotechnology has brought human numerous benefits:Through the application of biotechnology, a broad and significant increase of food production can be happily seen at global agricultural production. But when we enjoy the enormous b
2、enefits of the GM food,a new but alarming problem also came that if these food is safe enough for people?if something seriously happened,what can we do?Maybe you can find some answer in this thesis.Key Words: modern biotechnology GM food safety1Contentsabstract in English 1chapter 1 intruduction.3ch
3、apter 2 Status of genetically modified foods 4Chapter 3 GM food safety issues .5Chapter 4 Conclusion .10Reference112Chapter 1 IntroductionWhat is biotechnology?Maybe not too mang people know its definition accurately.Biotechnology is a technology which can reform and make the use of the natural live
4、s on the ingredient of them by taking advantage of the research finds in life sciences which can greatly follow the will of people.In its purest form,the term “biotechnology“ refers to the use of living organisms or their products to modify human health and the human environment.Biotechnology in one
5、 form or another has flourished since prehistoric times. When the first human beings realized that they could plant their own crops and breed their own animals, they learned to use biotechnology. The discovery that fruit juices fermented into wine, or that milk could be converted into cheese or yogu
6、rt, or that beer could be made by fermenting solutions of malt and hops began the study of biotechnology. When the first bakers found that they could make a soft, spongy bread rather than a firm, thin cracker, they were acting as fledgling biotechnologists. The first animal breeders, realizing that
7、different physical traits could be either magnified or lost by mating appropriate pairs of animals, engaged in the manipulations of biotechnology. 3Chapter 2 Status of genetically modified foodAs we all know,modern biotechnology has brought human numerous benifits:Through the application of biotechn
8、ology, a broad and significant increase of food production can be happily seen at global agricultural production.Since 1983 when the first time human got transgenic tobacco, potato by using recombinant DNA technology,the plant genetic engineering technology in the world has achieved rapid developmen
9、t of transgenic plants for research and development,which has made a series of remarkable progress and has Successfully nurtured a number of crops with disease-resistance,insecticide resistance and even an incredible high-yield.with the help of them,we can feed another more than millions of people,A
10、ccording to statistics,up to now ,no less than 1.6 billion people have benefits from biotechnology.in the area,our mother country China has made tremendous contributions to the worlds biotechnology.what must be mentioned is BT cotton and hybrid rice of Yuan Longping. Commercialize genetically modifi
11、ed crops dates from the year of 1996,including Soybeans, cotton, cereals and oilseed rape.GM crops now occupy 10% of global arable land. In 2010,81% of worldwide soybean, 64% cotton, 29% and 23% of the grain is genetically modified oilseed rape.Totally,29 countries grow GM products all over the worl
12、d.the top three country with the largest area of cultivation is United States, Brazil and Argentina.The problem About the safety of GM products has been controversial.Genetically modified food will bring human and animal allergens and toxins of unknown.4Chapter 3 GM food safety issuesInternational c
13、onsensus has been reached on the principles regarding evaluation of the food safety of genetically modified plants. The concept of substantial equivalence has been developed as part of a safety evaluation framework, based on the idea that existing foods can serve as a basis for comparing the propert
14、ies of genetically modified foods with the appropriate counterpart. Application of the concept is not a safety assessment per se, but helps to identify similarities and differences between the existing food and the new product, which are then subject to further toxicological investigation. Substanti
15、al equivalence is a starting point in the safety evaluation, rather than an endpoint of the assessment. Consensus on practical application of the principle should be further elaborated. Experiences with the safety testing of newly inserted proteins and of whole genetically modified foods are reviewe
16、d, and limitations of current test methodologies are discussed. The development and validation of new profiling methods such as DNA microarray technology, proteomics, and metabolomics for the identification and characterization of unintended effects, which may occur as a result of the genetic modifi
17、cation, is recommended. The assessment of the allergenicity of newly inserted proteins and of marker genes is discussed. An issue that will gain importance in the near future is that of post-marketing surveillance of the foods derived from genetically modified crops. It is concluded, among others th
18、at, that application of the principle of substantial equivalence has proven adequate, and that no alternative adequate safety assessment strategies are available.At an early stage in the introduction of recombinant-DNA technology in modern plant breeding and biotechnological food production systems,
19、 efforts began to define internationally harmonized evaluation strategies for the safety of foods derived from genetically modified organisms (GMOs). Two years after the first successful transformation experiment in plants (tobacco) in 1988, the International Food Biotechnology Council (IFBC) publis
20、hed the first report on the issue of safety assessment of these new varieties (IFBC, 1990). The comparative approach described in this report has laid the basis for later safety evaluation strategies. Other 5organizations, such as the Organisation for Economic Cooperation and Development (OECD), the
21、 Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) and the International Life Sciences Institute (ILSI) have developed further guidelines for safety assessment which have obtained broad international consensus among experts on food safety evaluatio
22、n.At 1993. the OECD formulated the concept of substantial equivalence as a guiding tool for the assessment of genetically modified foods, which has been further elaborated in the following years (OECD, 1993; OECD, 1996; OECD, 1998; Figure 1). The concept of substantial equivalence is part of a safet
23、y evaluation framework based on the idea that existing foods can serve as a basis for comparing the properties of a genetically modified food with the appropriate counterpart. The existing food supply is considered to be safe, as experienced by a long history of use, although it is recognized that f
24、oods may contain many anti-nutrients and toxicants which, at certain levels of consumption, may induce deleterious effects in humans and animals. Application of the concept is not a safety assessment per se, but helps to identify similarities and potential differences between the existing food and t
25、he new product, which is then subject to further toxicological investigation. Three scenarios are envisioned in which the genetically modified plant or food would be (i) substantially equivalent; (ii) substantially equivalent except for the inserted trait; or (iii) not equivalent at all. A compositi
26、onal analysis of key components, including key nutrients and natural toxicants, is the basis of assessment of substantial equivalence, in addition to phenotypic and agronomic characteristics of the genetically modified plant.In the first scenario, no further specific testing is required as the produ
27、ct has been characterized as substantially equivalent to a traditional counterpart whose consumption is considered to be safe, for example, starch from potato. In the second scenario, substantial equivalence would apply except for the inserted trait, and so the focus of the safety testing is on this
28、 trait, for example, an insecticidal protein of genetically modified tomato. Safety tests include specific toxicity testing according to the nature and function of the newly expressed protein; potential occurence of unintended effects; potential for gene transfer from genetically modified foods to h
29、uman/animal gut flora; the potential allergenicity of the newly inserted traits; and the 6role of the new food in the diet . In the third scenario, the novel crop or food would be not substantially equivalent with a traditional counterpart, and a case-by-case assessment of the new food must be carri
30、ed out according to the characteristics of the new product.FAO（short for Food and Agriculture Organization） and WHO(World Health Organization) have been organizing workshops and consultations on the safety of GMOs since 1990. At the Joint FAO/WHO Consultation in 1996 (FAO/WHO, 1996) it was recommend
31、ed that the safety evaluation should be based on the concept of substantial equivalence, which is a dynamic, analytical exercise in the assessment of the safety of a new food relative to an existing food. The following parameters should be considered to determine the substantial equivalence of a gen
32、etically modified plant: molecular characterization; phenotypic characteristics; key nutrients; toxicants; and allergens.The distinction between three levels of substantial equivalence (complete, partial, non-) of the novel food to its counterpart, and the subsequent decisions for further testing ba
33、sed upon substantial equivalence, are similar to those defined by OECD (1996).The Codex Alimentarius Commission of FAO/WHO is committed to the international harmonization of food standards. Food standards developed by Codex Alimentarius should be adopted by the participating national governments. Th
34、e Codex ad hoc Intergovern mental Task Force on Foods Derived from Biotechnology has the task to develop standards, guidelines and other recommendations for genetically modified foods. During its first session in Chiba (Japan) in March 2000 definitions were agreed concerning the risk assessment and
35、risk analysis of genetically modified foods. Risk assessment covers issues such as food safety, substantial equivalence and long-term health effects, while risk analysis may include decision-making and post-market monitoring.An Expert Consultation held in Geneva, Switzerland in May/June 2000 evaluat
36、ed experiences gathered since the 1996 Consultation. Topics considered included substantial equivalence, unintended effects of genetic modification, food safety, 7nutritional effects, antibiotic resistance marker genes, and allergenicity. The Consultation endorsed the concept of substantial equivale
37、nce as a pragmatic approach for the safety assessment of genetically modified foods, and concluded that at present no suitable alternative strategies are available. Application of the concept is a starting point for safety assessment, rather than an end-point. It identifies similarities and possible
38、 differences between the genetically modified food and its appropriate counterpart, which should then be assessed further.The issue of the potential occurrence of unintended effects due to the genetic modification process, such as the loss of existing traits or the acquisition of new ones, was exami
39、ned. The occurrence of unintended effects is not unique for the application of recDNA techniques, but also occurs frequently in conventional breeding. Present approaches to detecting such effects focus on chemical analysis of known nutrients and toxicants (targeted approach). In order to increase th
40、e possibility of detecting unintended effects, profiling/fingerprinting methods are considered useful alternatives (non-targeted approach). This is of particular interest for plants with extensive modifications of the genome (second generation of genetically modified foods) where chances of the occu
41、rrence of unintended effects may increase.Animal studies are deemed necessary to obtain information on the characteristics of newly expressed proteins, analogous to the conventional toxicity testing of food additives. Testing of whole foods may be considered if relevant changes in composition may ha
42、ve taken place in addition to the expected ones; however, such studies should be considered on a case-by-case basis, taking the limitations of this type of study into account. The minimum requirement to demonstrate the safety of long-term consumption of a food is a subchronic 90-day study. Longer-te
43、rm studies may be needed if the results of a 90-day study indicate adverse effects such as proliferative changes in tissues.The Expert Consultation noted that, in general, very little is known about the potential long-term effects of any foods, and that identification of such effects may be very dif
44、ficult, if not impossible, due to the many confounding factors and the great genetic variability in food-related effects among the population. Thus the identification of long-term effects specifically attributable to genetically modified foods is highly 8unlikely. Epidemiological studies are not lik
45、ely to identify such effects given the high background of undesirable effects of conventional foods. The Consultation was of the opinion that pre-market safety assessment already gives an assurance that genetically modified foods are as safe as their conventional counterparts. Experimental studies,
46、such as randomized controlled human trials, if properly performed, might provide additional evidence for human safety in the medium to long term.9Chapter 4 ConclusionFrom the above,we can clearly see that since the GM food isnt exactly safe,but our country and some international organizations like F
47、AO and WHO developed a sufficient number of rules and regulations to reduce the risk of accidents.and whats more,since now not any serious GM safety accident has happened.so we can enjoy the benefits of the modern biotechnology.so much worries isnt needed,and we are also trying some new way which ca
48、n avoid the accident.GM food is safe enough only if we follow the rules.and we can use the modern biotechnology.10Reference1Pamela Peter：Pamela Peters, from Biotechnology: A Guide To Genetic Engineering. Wm. C. Brown Publishers, Inc., 1993.2Fred Gould:Can Agricultural Biotechnology be Green? 3Norman Borlaug:Biotechnology and the Green Revolution
