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1 Page 1 of 6 Searh All WHO This site only Home About WHO Countries Health topis Publiations Data and statistis Programmes and projets Food Safety Zoonoses Mirobiologial risks Chemial risks Biotehnology and nanotehnology Food standards (Codex Alimentarius) Foodborne disease Food prodution to onsumption Capaity building Consumer eduation Food safety About Contat us Publiations Related links WHO > Programmes and projets > Food safety > Publiations related to food safety > Biotehnology (GM foods) publiations printable version 20 questions on genetially modified foods :: Full text in English [pdf 112kb] :: Full text in Frenh [pdf 106kb] :: Full text in Spanish [pdf 117kb] :: Full text in Russian [pdf 258kb] :: Full text in Chinese [pdf 212kb] :: Full text in Arabi [pdf 587kb] :: Full text in Estonian [pdf 75kb] 20 QUESTIONS ON GENETICALLY MODIFIED (GM) FOODS Q1. What are genetially modified (GM) organisms and GM foods? These questions and answers have been prepared by WHO in response to questions and onerns by a number of WHO Member State Governments with regard to the nature and safety of genetially modified food. Genetially modified organisms (GMOs) an be defined as organisms in whih the geneti material (DNA) has been altered in a way that does not our naturally. The tehnology is often alled modern biotehnology or gene tehnology, sometimes also reombinant DNA tehnology or geneti engineering. It allows seleted individual genes to be transferred from one organism into another, also between non-related speies. Suh methods are used to reate GM plants whih are then used to grow GM food rops. Q2. Why are GM foods produed? GM foods are developed and marketed beause there is some pereived advantage either to the produer or onsumer of these foods. This is meant to translate into a produt with a lower prie, greater benefit (in terms of durability or nutritional value) or both. Initially GM seed developers wanted their produts to be aepted by produers so have onentrated on innovations that farmers (and the food industry more generally) would appreiate. The initial objetive for developing plants based on GM organisms was to improve rop protetion. The GM rops urrently on the market are mainly aimed at an inreased level of rop protetion through the introdution of resistane against plant diseases aused by insets or viruses or through inreased tolerane towards herbiides. Inset resistane is ahieved by inorporating into the food plant the gene for toxin prodution from the baterium Baillus thuringiensis (BT). This toxin is urrently used as a onventional insetiide in agriulture and is safe for human onsumption. GM rops that permanently produe this toxin have been shown to require lower quantities of insetiides in speifi situations, e.g. where pest pressure is high. Virus resistane is ahieved through the introdution of a gene from ertain viruses whih ause disease in plants. Virus resistane makes plants less suseptible to diseases aused by suh viruses, resulting in higher rop yields. Herbiide tolerane is ahieved through the introdution of a gene from a baterium onveying resistane to some herbiides. In situations where weed pressure is high, the use of suh rops has resulted in a redution in the quantity of the herbiides used. Q3 Are GM foods assessed differently from traditional foods?

2 Page 2 of 6 traditional breeding tehniques may not be evaluated rigorously using risk assessment tehniques. With GM foods most national authorities onsider that speifi assessments are neessary. Speifi 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. Hene there is a signifiant differene in the evaluation proess prior to marketing for these two groups of food. One of the objetives of the WHO Food Safety Programme is to assist national authorities in the identifiation of foods that should be subjet to risk assessment, inluding GM foods, and to reommend the orret assessments. Q4. How are the potential risks to human health determined? The safety assessment of GM foods generally investigates: (a) diret health effets (toxiity), (b) tendenies to provoke allergi reation (allergeniity); () speifi omponents thought to have nutritional or toxi properties; (d) the stability of the inserted gene; (e) nutritional effets assoiated with geneti modifiation; and (f) any unintended effets whih ould result from the gene insertion. Q5. What are the main issues of onern for human health? While theoretial disussions have overed a broad range of aspets, the three main issues debated are tendenies to provoke allergi reation (allergeniity), gene transfer and outrossing. Allergeniity. As a matter of priniple, the transfer of genes from ommonly allergeni foods is disouraged unless it an be demonstrated that the protein produt of the transferred gene is not allergeni. While traditionally developed foods are not generally tested for allergeniity, protools for tests for GM foods have been evaluated by the Food and Agriulture Organization of the United Nations (FAO) and WHO. No allergi effets have been found relative to GM foods urrently on the market. Gene transfer. Gene transfer from GM foods to ells of the body or to bateria in the gastrointestinal trat would ause onern if the transferred geneti material adversely affets human health. This would be partiularly relevant if antibioti resistane genes, used in reating GMOs, were to be transferred. Although the probability of transfer is low, the use of tehnology without antibioti resistane genes has been enouraged by a reent FAO/WHO expert panel. Outrossing. The movement of genes from GM plants into onventional rops or related speies in the wild (referred to as outrossing ), as well as the mixing of rops derived from onventional seeds with those grown using GM rops, may have an indiret effet on food safety and food seurity. This risk is real, as was shown when traes of a maize type whih was only approved for feed use appeared in maize produts for human onsumption in the United States of Ameria. Several ountries have adopted strategies to redue mixing, inluding a lear separation of the fields within whih GM rops and onventional rops are grown. Feasibility and methods for post-marketing monitoring of GM food produts, for the ontinued surveillane of the safety of GM food produts, are under disussion. Q6. How is a risk assessment for the environment performed? Environmental risk assessments over both the GMO onerned and the potential reeiving environment. The assessment proess inludes evaluation of the harateristis of the GMO and its effet and stability in the environment, ombined with eologial harateristis of the environment in whih the introdution will take plae. The assessment also inludes unintended effets whih ould result from the insertion of the new gene. Q7. What are the issues of onern for the environment? Issues of onern inlude: the apability of the GMO to esape and potentially introdue the engineered genes into wild populations; the persistene of the gene after the GMO has been harvested; the suseptibility of non-target organisms (e.g. insets whih are not pests) to the gene produt; the stability of the gene; the redution in the spetrum of other plants inluding loss of biodiversity; and inreased use of hemials in agriulture. The environmental safety aspets of GM rops vary onsiderably aording to loal onditions.

3 Page 3 of 6 Q8. Are GM foods safe? Different GM organisms inlude different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a ase-by-ase basis and that it is not possible to make general statements on the safety of all GM foods. GM foods urrently available on the international market have passed risk assessments and are not likely to present risks for human health. In addition, no effets on human health have been shown as a result of the onsumption of suh foods by the general population in the ountries where they have been approved. Continuous use of risk assessments based on the Codex priniples and, where appropriate, inluding post market monitoring, should form the basis for evaluating the safety of GM foods. Q9. How are GM foods regulated nationally? The way governments have regulated GM foods varies. In some ountries GM foods are not yet regulated. Countries whih have legislation in plae fous primarily on assessment of risks for onsumer health. Countries whih have provisions for GM foods usually also regulate GMOs in general, taking into aount health and environmental risks, as well as ontrol- and trade-related issues (suh as potential testing and labelling regimes). In view of the dynamis of the debate on GM foods, legislation is likely to ontinue to evolve. Q10. What kind of GM foods are on the market internationally? All GM rops available on the international market today have been designed using one of three basi traits: resistane to inset damage; resistane to viral infetions; and tolerane towards ertain herbiides. All the genes used to modify rops are derived from miroorganisms. Q11. What happens when GM foods are traded internationally? No speifi international regulatory systems are urrently in plae. However, several international organizations are involved in developing protools for GMOs. The Codex Alimentarius Commission (Codex) is the joint FAO/WHO body responsible for ompiling the standards, odes of pratie, guidelines and reommendations that onstitute the Codex Alimentarius: the international food ode. Codex is developing priniples for the human health risk analysis of GM foods. The premise of these priniples ditates a premarket assessment, performed on a ase-by-ase basis and inluding an evaluation of both diret effets (from the inserted gene) and unintended effets (that may arise as a onsequene of insertion of the new gene). The priniples are at an advaned stage of development and are expeted to be adopted in July Codex priniples do not have a binding effet on national legislation, but are referred to speifially in the Sanitary and Phytosanitary Agreement of the World Trade Organization (SPS Agreement), and an be used as a referene in ase of trade disputes. The Cartagena Protool on Biosafety (CPB), an environmental treaty legally binding for its Parties, regulates transboundary movements of living modified organisms (LMOs). GM foods are within the sope of the Protool only if they ontain LMOs that are apable of transferring or repliating geneti material. The ornerstone of the CPB is a requirement that exporters seek onsent from importers before the first shipment of LMOs intended for release into the environment. The Protool will enter into fore 90 days after the 50th ountry has ratified it, whih may be in early 2003 in view of the aelerated depositions registered sine June Q12. Have GM produts on the international market passed a risk assessment? The GM produts that are urrently on the international market have all passed risk assessments onduted by national authorities. These different assessments in general follow the same basi priniples, inluding an assessment of environmental and human health risk. These assessments are thorough, they have not indiated any risk to human health. Q13. Why has there been onern about GM foods among some politiians, publi interest groups and onsumers, espeially in Europe? Sine the first introdution on the market in the mid-1990s of a major GM food (herbiide-resistant soybeans), there has been inreasing onern about suh food among politiians, ativists and onsumers espeially in Europe Several fators are involved

4 Page 4 of 6 Consumers frequently ask, what is in it for me?. Where mediines are onerned, many onsumers more readily aept biotehnology as benefiial for their health (e.g. mediines with improved treatment potential). In the ase of the first GM foods introdued onto the European market, the produts were of no apparent diret benefit to onsumers (not heaper, no inreased shelf-life, no better taste). The potential for GM seeds to result in bigger yields per ultivated area should lead to lower pries. However, publi attention has foused on the risk side of the risk-benefit equation. Consumer onfidene in the safety of food supplies in Europe has dereased signifiantly as a result of a number of food sares that took plae in the seond half of the 1990s that are unrelated to GM foods. This has also had an impat on disussions about the aeptability of GM foods. Consumers have questioned the validity of risk assessments, both with regard to onsumer health and environmental risks, fousing in partiular on long-term effets. Other topis for debate by onsumer organizations have inluded allergeniity and antimirobial resistane. Consumer onerns have triggered a disussion on the desirability of labelling GM foods, allowing an informed hoie. At the same time, it has proved diffiult to detet traes of GMOs in foods: this means that very low onentrations often annot be deteted. Q14. How has this onern affeted the marketing of GM foods in the European Union? The publi onerns about GM food and GMOs in general have had a signifiant impat on the marketing of GM produts in the European Union (EU). In fat, they have resulted in the so-alled moratorium on approval of GM produts to be plaed on the market. Marketing of GM food and GMOs in general are the subjet of extensive legislation. Community legislation has been in plae sine the early 1990s. The proedure for approval of the release of GMOs into the environment is rather omplex and basially requires agreement between the Member States and the European Commission. Between 1991 and 1998, the marketing of 18 GMOs was authorized in the EU by a Commission deision. As of Otober 1998, no further authorizations have been granted and there are urrently 12 appliations pending. Some Member States have invoked a safeguard lause to temporarily ban the plaing on the market in their ountry of GM maize and oilseed rape produts. There are urrently nine ongoing ases. Eight of these have been examined by the Sientifi Committee on Plants, whih in all ases deemed that the information submitted by Member States did not justify their bans. During the 1990s, the regulatory framework was further extended and refined in response to the legitimate onerns of itizens, onsumer organizations and eonomi operators (desribed under Question 13). A revised diretive will ome into fore in Otober It will update and strengthen the existing rules onerning the proess of risk assessment, risk management and deision-making with regard to the release of GMOs into the environment. The new diretive also foresees mandatory monitoring of long-term effets assoiated with the interation between GMOs and the environment. Labelling in the EU is mandatory for produts derived from modern biotehnology or produts ontaining GM organisms. Legislation also addresses the problem of aidental ontamination of onventional food by GM material. It introdues a 1% minimum threshold for DNA or protein resulting from geneti modifiation, below whih labelling is not required. In 2001, the European Commission adopted two new legislative proposals on GMOs onerning traeability, reinforing urrent labelling rules and streamlining the authorization proedure for GMOs in food and feed and for their deliberate release into the environment. The European Commission is of the opinion that these new proposals, building on existing legislation, aim to address the onerns of Member States and to build onsumer onfidene in the authorization of GM produts. The Commission expets that adoption of these proposals will pave the way for resuming the authorization of new GM produts in the EU. Q15. What is the state of publi 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 publi debate in many parts of the world. This debate is likely to ontinue, probably in the broader ontext of other uses of biotehnology (e.g. in human mediine) and their onsequenes for human soieties. Even though the issues under debate are usually very similar (osts and benefits, safety issues), the outome of the debate differs from ountry to ountry. On issues suh as labelling and traeability of GM foods as a way to address onsumer onerns, there is no onsensus to date. This has beome apparent during disussions within the Codex Alimentarius Commission over the past few years. Despite the lak of onsensus on these topis, signifiant progress has been made on the harmonization of views onerning risk assessment. The Codex Alimentarius Commission is about to adopt priniples on

5 Page 5 of 6 environmental and food safety fears. Although workable solutions have been found for distribution of milled grain in some ountries, others have restrited the use of GM food aid and obtained ommodities whih do not ontain GMOs. Q16. Are people s reations 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 soietal and historial onnotations, and in some instanes may have religious importane. Tehnologial modifiation of food and food prodution an evoke a negative response among onsumers, espeially in the absene of good ommuniation on risk assessment efforts and ost/benefit evaluations. Q17. Are there impliations for the rights of farmers to own their rops? Yes, intelletual property rights are likely to be an element in the debate on GM foods, with an impat on the rights of farmers. Intelletual property rights (IPRs), espeially patenting obligations of the TRIPS Agreement (an agreement under the World Trade Organization onerning trade-related aspets of intelletual property rights) have been disussed in the light of their onsequenes on the further availability of a diversity of rops. In the ontext of the related subjet of the use of gene tehnology in mediine, WHO has reviewed the onflit between IPRs and an equal aess to geneti resoures and the sharing of benefits. The review has onsidered potential problems of monopolization and doubts about new patent regulations in the field of geneti sequenes in human mediine. Suh onsiderations are likely to also affet the debate on GM foods. Q18. Why are ertain groups onerned about the growing influene of the hemial industry on agriulture? C Certain groups are onerned about what they onsider to be an undesirable level of ontrol of seed markets by a few hemial ompanies. Sustainable agriulture and biodiversity benefit most from the use of a rih variety of rops, both in terms of good rop protetion praties as well as from the perspetive of soiety at large and the values attahed to food. These groups fear that as a result of the interest of the hemial industry in seed markets, the range of varieties used by farmers may be redued mainly to GM rops. This would impat on the food basket of a soiety as well as in the long run on rop protetion (for example, with the development of resistane against inset pests and tolerane of ertain herbiides). The exlusive use of herbiide-tolerant GM rops would also make the farmer dependent on these hemials. These groups fear a dominant position of the hemial industry in agriultural development, a trend whih they do not onsider to be sustainable. Q19. What further developments an be expeted in the area of GMOs? Future GM organisms are likely to inlude plants with improved disease or drought resistane, rops with inreased nutrient levels, fish speies with enhaned growth harateristis and plants or animals produing pharmaeutially important proteins suh as vaines. At the international level, the response to new developments an be found in the expert onsultations organized by FAO and WHO in 2000 and 2001, and the subsequent work of the Codex ad ho Task Fore on Foods Derived from Biotehnology. This work has resulted in an improved and harmonized framework for the risk assessment of GM foods in general. Speifi questions, suh as the evaluation of allergeniity of GM foods or the safety of foods derived from GM miroorganisms, have been overed and an expert onsultation organized by FAO and WHO will fous on foods derived from GM animals in Q20. What is WHO doing to improve the evaluation of GM foods? WHO will take an ative role in relation to GM foods, primarily for two reasons: (1) on the grounds that publi health ould benefit enormously from the potential of biotehnology, for example, from an inrease in the nutrient ontent of foods, dereased allergeniity and more effiient food prodution; and (2) based on the need to examine the potential negative effets on human health of the onsumption of food produed through geneti modifiation, also at the global level. It is lear that modern tehnologies must be thoroughly evaluated if they are to onstitute a true improvement in the way food is produed. Suh evaluations must be holisti and all-inlusive, and annot stop at the previously separated, non-oherent systems of evaluation fousing solely on human health or environmental effets in isolation. Wo k is the efo e nde a in WHO to p esent a b oade ie of the e al ation of GM foods in o de to

6 Page 6 of 6 with other key organizations, notably FAO and the United Nations Environment Programme (UNEP). It is hoped that this report ould form the basis for a future initiative towards a more systemati, oordinated, multi-organizational and international evaluation of ertain GM foods. Contats sams Employment FAQs Feedbak Privay RSS feeds WHO 2010

20 questions on genetically modified foods

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