1. Genetically Modified Organisms (GMOs) Genetically Modified Organisms (GMOs) are organisms in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination. GMOs can be bacteria, fungi, animals, plants and viruses, with the exception of human beings since there are legal constraints. Common GMOs include agricultural crops that have been genetically modified for greater productivity or for resistance to pests or diseases. Examples of modified crops include soybeans, cotton and maize.

2. In the past, traditional plant breeders have introduced desired characteristics into a plant by crossing different varieties to mix their genes and thereby alter the genetic make-up. This process is called 'selective breeding'. Nowadays, research and development have led to a better understanding of the science of genes. In fact, scientists have managed to take out a single gene from the DNA of one organism and insert it into the DNA of another organism, to confer the desired traits, such as a plant that is resistant to a specific pest or disease. This transfer is also possible between non-related species.

3. Biosafety Biosafety is a term used to describe efforts to reduce and eliminate the potential risks from biotechnology products, including GMOs and their production.

4. Contained Use of GMOs Contained Use is defined as "any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with the general population and the environment".

5. The term 'contained use' covers any activity involving genetically modified micro-organisms (GMMs) carried out under containment and in which measures are taken to limit contact between these organisms, people and the environment. It relates to the actual process of genetic modification, as well as to the use, storage, transport and destruction of GMOs.

6. Typical contained use facilities can be microbiology laboratories, animal houses, greenhouses or industrial production facilities. For example, before GMOs where invented, medicinal products such as insulin, blood factor VIII and human growth hormone, were formerly collected from dead humans and animals. These were collected in small amounts and always carried the risk of transmitting disease. Now, with the use of genetic modification (GM) technology, pure and safe equivalents can be produced in larger quantities using GM bacteria.

7. Why do we need controls and legislation? A considerable number of contained use activities involve organisms which do not cause disease and are very unlikely to survive in the environment outside a containment facility. However, some contained use activities are carried out with more hazardous organisms whose escape from containment could result in adverse effects on human health and / or the environment. It is, therefore, very important to assess the risks of all activities and to make sure that any necessary controls are put in place to protect people and the environment.

8. Classification of GMOs Local and EU legislation classify GMOs into four classes: Class 1 - activities of no or negligible risk Class 2 - activities of low risk Class 3 - activities of moderate risk Class 4 - activities of high risk Most genetically modified plants are considered to be Class 1 because they are not usually modified to contain DNA sequences from human disease causing organisms. Class 4 is reserved for highly dangerous human or animal pathogens such as small pox which are highly transmissible and for which there is no prophylaxis.

9. Release of GMOs into the Environment

10. The release of a GMO into the environment means an introduction of the GMO into the environment, without any precise confinement measure being taken to restrict the contact between this GMO and the population or the environment in general. There are two broad categories of release of GMOs into the environment:

11. 1. the experimental release of GMOs into the environment - that is, the introduction of GMOs into the environment for experimental purposes, also commonly known as field or clinical trials. These types of releases are mainly carried out for the purposes of study, research, demonstration and development of novel varieties. The behaviour of the GMO in an open environment and its interactions with other organisms and the environment are studied. 2. release of GMOs into the environment by placing on the market for commercial purposes - if the results of the experimental release are positive, the company may decide to place the GMO on the market, that is, make it available to third parties either free of charge or for a fee. The GMO may be placed on the market for purposes of cultivation, importation or transformation of GMOs into industrial products.

12. Why and how are releases regulated?

13. Although considerable work has been carried out in the field of GMOs and a large amount of data has been gathered, there are still concerns as regards the safety of human health and the environment. The regulations apply to all GMOs, although plants have been the subject of most interest in recent years. The legislation adopts a step-by-step approval process on a case-by-case assessment of the risks to human health and the environment before any GMO, such as maize, tomatoes, or microorganisms, can be released into the environment. The entire regulatory process is underpinned by a detailed environmental risk assessment, prepared by the applicant, who examines and evaluates any possible harmful consequences of releasing a particular GMO. Products derived from GMOs, such as paste or ketchup from a GMO tomato, are not covered by these regulations.

14. The key stakeholders who may be affected by these regulations include: importers of seeds, grains and crops importers of other organisms, such as animals and micro- organisms farmers research institutions including biotech companies.

15. Any release of GMOs into the environment must comply with the provisions of Legal Notice 170 of 2002. The legal requirements and obligations of this legislation include:Legal Notice 170 of 2002 observing the laid down principles for the environmental risk assessment mandatory post-market monitoring requirements, including long-term effects associated with the interaction with other GMOs and the environment, mandatory information to the public a requirement for Member States to ensure labelling and traceability at all stages of the placing on the market first approvals for the release of GMOs to be limited to a maximum of ten years phasing out the release of GMOs containing antibiotic resistance marker (ARM) genes, which may have adverse effects on human health and the environment an obligation to consult the Scientific Committee(s) / European Food Safety Authority (EFSA) the possibility for the Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority

16. Principles for the environmental risk assessment: The safety of GMOs depends on the inserted genetic material, the GMO that is produced, the receiving environment and the interaction between the GMO and the environment. The objective of the environmental risk assessment is to identify and evaluate potential adverse effects of the GMO(s), direct or indirect, immediate or delayed. The environmental risk assessment also requires evaluation in terms of how the GMO was developed and examines the potential risks associated with the new GMO (for example toxic or allergenic proteins), and the possibility of gene-transfer (for example of antibiotic resistance genes).

17. The risk assessment methodology is as follows: identification of any characteristics of the GMO(s) which may cause adverse effects evaluation of the potential consequences of each adverse effect evaluation of the likelihood of the occurrence of each identified potential adverse effect estimation of the risk posed by each identified characteristic of the GMO(s) application of management strategies for risks resulting from the experimental release or placing on the market of GMO(s) determination of the overall risk of the GMO(s)

18. Procedural steps & timescales for the experimental release of GMOs

19. Submission: The applicant should contact MEPA prior to submitting a notification, in order to advise that a notification is to be submitted and clarify any uncertainties before submission. Applicants must then submit a detailed notification to MEPA. Amongst the information required in the notification, it should include: information on the nature of the GMO; how it has been modified; the precise nature of the research programme proposed; where it will be released and how will the release be monitored. Once MEPA confirms that the notification is complete, the notification is considered as valid, and the review process commences.

20. Review: MEPA has 90 days to review the notification. The information in the notification, which is duly marked for inclusion in the public register, would be made available to the public. MEPA forwards the notification to its advisory committee, the Biosafety Co- ordinating Committee (BCC), to examine the application and put forward a recommendation. The Summary Notification Information Format (SNIF) submitted with the notification is sent to the European Commission within 30 days after the review process has initiated.

21. Decision-making: Following consideration of the recommendation by the BCC, MEPA will grant/reject consent. If a consent is granted it is likely to include a number of conditions, by which the applicant has to abide.

22. Procedural steps & timescales for the placing on the market of GMOs

23. Submission: The applicant submits a notification to a national competent authority of a Member State of his own choice. The notifications must contain a full environmental risk assessment, including amongst others, a post-marketing monitoring plan and a proposal for labelling and packaging.

24. Review: The Member State where the notification was submitted takes the lead and conducts a thorough review of the notification. If a negative opinion is given, the applicant may wish to withdraw the notification, before it is circulated and hence becomes public. If a favourable opinion is given by the lead Member State, the full notification, the Member State's assessment report and the SNIF are forwarded to the European Commission.

25. Consultation: The Commission circulates the notification to the other 24 Member States for further evaluation and comments by their competent authorities, as the final decision is then subject to a collective decision by all EU Member States. MEPA can therefore be the competent authority which takes the lead, if the applicant submits the notification in Malta, or one of the competent authorities of the 24 Member States, which are consulted at this stage. This first consultation period is of 60 days and as part of the review of any such application, MEPA seeks the recommendation of the Biosafety Co- ordinating Committee (BCC).

26. If there are no objections by the Member States, the competent authority that carried out the original assessment, grants the consent for the placing on the market of the GMO. This consent is valid throughout the EU. If objections are raised, the applicant is allowed to respond to the Member States' objections and comments. The applicant's responses are circulated by the Commission to the Member States and a further 45 days are allowed for Member States to evaluate the information submitted by the applicant. If objections are maintained by any of the Member States during this second and final period of consultation, a decision has to be taken at Community level.

27. Decision-making: The Commission first asks the opinion of its Scientific Committees. If the scientific opinion is favourable, the Commission then proposes a draft Decision to the Regulatory Committee composed of representatives of Member States, for opinion. If the Regulatory Committee gives a favourable opinion by qualified majority, the Commission adopts the Decision and a consent is issued accordingly by the competent authority of the lead Member State. If not, the draft Decision is submitted to the Council of Ministers for adoption or rejection by qualified majority. If the Council does not act within 3 months, the Commission can adopt the decision.

28. Placing on the market: The consent is valid for the whole of the EU and it is subject to any conditions or restrictions agreed by Member States. Consent is given for a maximum period of 10 years for the initial consent. After 10 years a renewed application has to be submitted.

29. Public Participation & Consultation: During the regulatory process, the public is informed and has access to the publicly available data on the internet. Such data includes the SNIF and assessment report of the lead Member State. Comments may also be submitted here.publicly available data on the internet

30. GMOs authorised for placing on the EU market Numerous GMOs have been approved for placing on the EU market (also known as Part C releases). These authorisations cover a number of different intended uses. Several authorised GMOs have a scope which is restricted to import and processing, while some also include cultivation or food and feed as a requested use. Varieties of agricultural products include maize, oil seed rape, soybean and chicory. Numerous applications for the placing on the market of GMOs for authorisation are pending, e.g. maize, oil seed rape, cotton, rice.

31. National safeguard measures A number of Member States have invoked the so-called 'safeguard clause’. This clause provides that where a Member State has justifiable reasons to consider that a GMO, which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory. The scientific evidence provided by the Member States as justification for their measures was submitted to the Scientific Committees of the European Union for opinion.

32. Voting at regulatory committee meetings The Regulatory Committee, which is composed of representatives from the Competent Authorities of the Member States, assist the Commission in the regulatory procedure of the decision-making on applications for the placing on the market of GMOs (Part C releases). The Regulatory Committee is convened when no agreement is obtained amongst the Member States following the 45-day consultation period. A Commission Decision on the GMO in question would be put forward for voting by the Member States.

33. Voting takes place by qualified majority, which will be obtained if: -the decision receives at least 232 votes in favour or against the decision out of a total of 321 votes -the decision is approved by a majority of Member States -the decision is approved by at least 62% of the EU's population. If qualified majority in favour or against the decision is not reached at this meeting, the proposed decision would be forwarded to the Council of Environment Ministers for further voting, which has to take place within 3 months.

34. What is the BCC? The Biosafety Co-ordinating Committee (BCC) was set by means of the, Biosafety Co-ordinating Committee Regulations, 2002, whose aim is to achieve an integrated approach on biosafety, the contained use of GMMs, the deliberate release into the environment of GMOs and the placing on the market of GMOs, in order to achieve a high level of protection of human health and the environment. The main function of the BCC is to advise The Malta Environment and Planning Authority (MEPA) and the Minister responsible for the Environment on environmental implications of GMOs.

35. Fascinating facts about genetically modified organisms Genes are lengths of deoxyribonucleic acid (DNA) that are present in the nucleus of every cell. Human beings have about 30,000 genes. Biotechnology makes use of living organisms or their components, such as enzymes, to make products that include wine, cheese, beer, and yoghurt. Genetically modified crops look just like their traditional counterparts, but they have been engineered to possess special characteristics with the aim to make them better.

36. It takes ten years to develop a new genetically modified crop. The first plant that was modified by genetic engineering was produced in a laboratory in 1984. The first commercially grown genetically modified food crop was a tomato called the FlavrSavr in 1992. Considered to have a poor flavour, it never sold well and was off the market by 1997. Locating genes for important traits - such as those conferring insect resistance or desired nutrients - is one of the most limiting steps in the process of making GMOs.

37. Genes can be transferred from genetically modified crops to related plants by cross breeding - a process called hybridisation. Most of the insulin in the world is produced with the aid of GMOs. In the early 1980s a human gene for insulin production was inserted into the DNA of the bacteria E coli. With a much lower manufacturing cost, this process completely overtook the traditional source of insulin i.e. extraction from the pancreas of cows and pigs. The US is the world leader in biotech crops, with GM varieties accounting for 75% of US soybeans, some 70% of US cotton and 35% of US corn.

38. The estimated global area of approved biotech crops for 2004 was 81.0 million hectares. Approximately 8.25 million farmers in 17 countries grew biotech crops in 2004, up from 7 million farmers in 18 countries in 2003. In 2004, the 14 main countries that grow considerable amounts of biotech crops, were: USA with 59% of global total, followed by Argentina with 20%, Canada 6%, Brazil 6%, China 5%, Paraguay 2%, India 1%, South Africa 1%, Uruguay <1%, Australia <1%, Romania <1%, Mexico <1%, Spain <1%, and the Philippines <1%.

39. What is genetic engineering? Engineering is the technological manipulation of objects in a way that is perceived to result in benefits to mankind. This word has often been used in the context of inanimate nature, such as bridges, buildings and machines. However, the term can also be used in a biological context, namely for manipulating living organisms. Genetic engineering uses new methods of breeding that allow scientists to improve organisms. This is done by isolating genetic material from organisms, cutting this material and rejoining it to make new combinations. Copies of this recombined genetic material are then made and introduced into organisms to give them a specific desired trait or characteristic.

40. How is a GMO made? GMOs are made by genetic engineering techniques. The process involves altering or replacing parts of the genetic material of an existing organism. Therefore, the first step in making a GMO is to construct the new combination of genetic material that is to be inserted in the organism, and which will give a specific trait. This involves cutting and joining DNA from different sources so that they form a single stretch of genetic material. Cutting and joining of genetic material is done by using what are known as "enzymes", these being proteins that speed up reactions in organisms.

41. The next step involves inserting the newly created stretch of genetic material into an unmodified organism, for example a plant. Different techniques may be used to achieve this. One method involves the use of a "gene gun", which fires tiny metal particles coated with genetic material into the cells. Another procedure uses an Agro bacterium. This is a type of bacterium, which through a natural process, transfers part of its genes into the plant's DNA when it infects the plant. Prior to infecting the plant, the bacterium is modified so that part of its genes is replaced by the new stretch of genetic material. Thus, this new genetic material will be inserted into the plants' genes by the bacterium itself.

42. When making a GMO the natural process of reproduction is bypassed. In so doing, genes can be transferred between species that otherwise would not naturally interbreed. Thus, for instance, insect genes can end up in a plant, and genes from a bacterium can end up in an animal.

43. How does a GMO differ from its conventional counterpart? Conventional plant breeders mate individuals from the same species or related species to produce offspring, which will have genes from both parents. For thousands of years humans have been selecting the characteristics they prefer in plants and animals in order to satisfy their needs. This involved selecting and breeding the most beautiful, the strongest and the most productive, to produce offspring, which would have hopefully inherited some of the desirable traits. This process is called selective breeding. The result of this process is a population that is genetically diverse and preserves much of the initial genetic diversity of the parental lines. Selection occurs in successive generations until the desired results are achieved. It is therefore reasonably controllable and predictable, although it involves a lot of trial and error.

44. Nowadays, research and development have led to a better understanding of the science of genes. A GMO bypasses reproduction altogether, so a gene from a completely different species can be used. For example, tomatoes can be genetically modified to stay fresh for longer by inserting a gene from fish into their DNA - something that was not possible before by selective breeding. This process is precise and is not subject to so much trial and error. However, GMOs also lead to a lack of genetic diversity, since all resulting GMOs would express the exact same gene for a particular trait.

45. Why are GMOs produced? The discovery of the possibility to alter the genetic makeup of an organism has led to an explosion of research and development which has benefited many fields:

46. Agriculture Agricultural crop yields are increased, as fewer crops would succumb to diseases or pests. The quality of agricultural crops is improved - for example, by producing potatoes with an increased nutrient level. Crops, such as salt resistant and drought resistant crops, can be grown in areas, which are otherwise not easily farmed. The need for chemicals, such as pesticides, is reduced, as GM crops can be made resistant to certain insect pests. This would also have an added benefit of lowering the costs incurred by farmers.

47. GMOs offer a quicker and more predictable way to generate new cultivars. Tillage and fuel consumption can be reduced through the development of herbicide tolerant GM crops, thereby resulting in cost savings to the farmer. The need for chemicals, such as pesticides, is reduced, as GM crops can be made resistant to certain insect pests. This would also have an added benefit of lowering the costs incurred by farmers.

48. Medicine Medicines, such as human insulin, can be made in large quantities. Until the mid-1980's most insulin was produced by extracting insulin from the pancreas of swine and sheep. However, there was a recurring problem that there was not enough insulin for all diabetic persons. Thus, through the production of insulin from GMOs, enough insulin could be made available to diabetic patients.

49. The insulin produced through genetic engineering is identical to natural occurring insulin, with the advantage that it is bacteria and virus free, due to the sterile nature of the production process. GMOs can be used to produce vaccines and other drugs. Pharmaceuticals, which cannot be made in any other way, can be produced.

50. Environment protection Waste / pollution can be cleaned up with the action of living organisms, such as microbes or plants through bioremediation (for example, the sequestration of heavy metals from the soil by GM grasses. The grass can then be removed and burnt, allowing recovery of some of the valuable metals and an improvement in soil fertility.)

51. Reducing the need for chemical spraying leads to a reduction in the release of chemical substances, such as pesticides, which can have adverse effects on the environment. Reduced tillage has an associated benefit of reducing soil erosion and water loss on farms. The higher the yield of food per unit of land, the less land must be cleared to grow our food. The less land that is required to grow our food, the more that can be retained as forest and wilderness, where biodiversity can flourish.

52. Food production The production of some food products, such as cheese and yoghurt, can be made much faster than if allowed to follow its natural course. GMOs can help to alleviate the food shortage problem by ensuring food security.

53. Other Some flowers, such as carnations and orchids have been genetically modified to provide flower colours that do not occur naturally. Thus, the range of flower colours available on the market is increased.

54. What are the risks associated with GMOs? Despite the many benefits they can bring, GMOs may also carry some risks of unwanted side effects on agricultural production systems, human health and the environment: -Horizontal gene transfer into soil and gut microorganisms. -Creation of new invasive species commonly referred to as superweeds - the crossing of a modified gene to a weed can occur only if the GM crop has a local wild "relative" capable of interbreeding. There is concern that crop plants modified for herbicide tolerance and weeds will crossbreed, resulting in the transfer of herbicide resistance genes from the GM crops into weeds.

55. -The use of GM plants may result in impacts on non-target species. For example, insect resistant GM plants may affect non-target species, such as butterflies or moths that try to feed on the GM crop. -Increased risk of pesticide and herbicide resistance of pests to GMOs. -Possible spread of antibiotic resistance. -Contamination of organic and conventional crops with transgenes through cross-fertilisation or gene transfer. -Loss of biodiversity farm wildlife.

56. -Loss of crop genetic diversity. -Increase in herbicide use to control volunteers (weedy crop plants). -Creation of dangerous novel pathogens and diseases that may escape containment. -Potential instability of the inserted gene. -Potential allergenicity of foods. -Potential novel toxicity of foods.

57. Which are the most common types of GMOs? Plants have been the subject of most interest in recent years. The most common types of GM crops that have been developed and commercialised include genetically modified maize, soybean, oilseed rape and cotton varieties. Such varieties have been developed to be either resistant to a particular herbicide (weed killer) or to certain crop pests, namely insects. There have also been a number of plants developed to exhibit both traits simultaneously - that is, resistant to both certain insect pests and a particular herbicide.

58. Impacts of genetically modified organisms

59. While not all impacts have been fully researched, specific aspects have been documented. Genetically modified organisms are theorized to reduce production costs due to reduced chemical and mechanical needs in planting, maintenance, and harvest. Conceivably, this savings could in turn be passed on to the consumer. The most obvious benefits to consumers are the nutrition implications. The biotechnology of gene splicing allows for the opportunity of creating plants that will produce food that is more nutrient dense. This is the case with a product termed “Golden Rice,” which contains beta carotene, a source of vitamin A and iron. Rice is a dietary staple in most developing countries. These are the same countries that suffer from high rates of childhood blindness and maternal anemia. Iron and vitamin A have been identified to prevent or treat maternal anemia and blindness, respectively. Research efforts are underway to identify other ways to increase efficiency and productivity of our food sources, thus allowing us to prevent diseases and feed the growing population as well.

60. What are the nutritional concerns of consuming genetically modified organisms?

61. The most obvious nutrition concern with genetically modified organisms is the risk of allergic reactions. More than 90% of food allergies occur in response to specific proteins in milk, eggs, wheat, fish, tree nuts, peanuts, soybeans, and shellfish. The risk for allergic reaction stems from a protein from one of these foods incorporated into a food that does not cause a known allergic reaction. For example, if an individual who has a known allergy to peanuts unsuspectingly consumed a genetically modified organism that contained the allergenic protein from the peanut, conceivably the individual would experience an allergic reaction. This concern has been addressed with FDA measures put into place to prevent such a scenario. The FDA requires that each presenter of a genetically modified organism show scientific evidence that they have not incorporated an allergenic substance into their product. If the presenter cannot produce this evidence, the FDA requires a label on the product to alert the consumer of its possible allergic reaction.

62. Why are GM foods produced?

63. GM foods are developed – and marketed – because there is some perceived advantage either to the producer or consumer of these foods. This is meant to translate into a product with a lower price, greater benefit (in terms of durability or nutritional value) or both. Initially GM seed developers wanted their products to be accepted by producers so have concentrated on innovations that farmers (and the food industry more generally) would appreciate. The initial objective for developing plants based on GM organisms was to improve crop protection. The GM crops currently on the market are mainly aimed at an increased level of crop protection through the introduction of resistance against plant diseases caused by insects or viruses or through increased tolerance towards herbicides. Insect resistance is achieved by incorporating into the food plant the gene for toxin production from the bacterium Bacillus thuringiensis (BT). This toxin is currently used as a conventional insecticide in agriculture and is safe for human consumption. GM crops that permanently produce this toxin have been shown to require lower quantities of insecticides in specific situations, e.g. where pest pressure is high.

64. Virus resistance is achieved through the introduction of a gene from certain viruses which cause disease in plants. Virus resistance makes plants less susceptible to diseases caused by such viruses, resulting in higher crop yields. Herbicide tolerance is achieved through the introduction of a gene from a bacterium conveying resistance to some herbicides. In situations where weed pressure is high, the use of such crops has resulted in a reduction in the quantity of the herbicides used.

65. Are GM foods assessed differently from traditional foods?

66. Generally consumers consider that traditional foods (that have often been eaten for thousands of years) are safe. When new foods are developed by natural methods, some of the existing characteristics of foods can be altered, either in a positive or a negative way National food authorities may be called upon to examine traditional foods, but this is not always the case. Indeed, new plants developed through traditional breeding techniques may not be evaluated rigorously using risk assessment techniques.

67. With GM foods most national authorities consider that specific assessments are necessary. Specific 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. Hence there is a significant difference in the evaluation process prior to marketing for these two groups of food.

68. One of the objectives of the WHO Food Safety Programme is to assist national authorities in the identification of foods that should be subject to risk assessment, including GM foods, and to recommend the correct assessments.

69. How are the potential risks to human health determined?

70. The safety assessment of GM foods generally investigates: (a) direct health effects (toxicity) (b) tendencies to provoke allergic reaction (allergenicity); (c) specific components thought to have nutritional or toxic properties; (d) the stability of the inserted gene; (e) nutritional effects associated with genetic modification; and (f) any unintended effects which could result from the gene insertion.

71. What are the main issues of concern for human health?

72. While theoretical discussions have covered a broad range of aspects, the three main issues debated are tendencies to provoke allergic reaction (allergenicity), gene transfer and outcrossing. Allergenicity. As a matter of principle, the transfer of genes from commonly allergenic foods is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic. While traditionally developed foods are not generally tested for allergenicity, protocols for tests for GM foods have been evaluated by the Food and Agriculture Organization of the United Nations (FAO) and WHO. No allergic effects have been found relative to GM foods currently on the market. Gene transfer. Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used in creating GMOs, were to be transferred. Although the probability of transfer is low, the use of technology without antibiotic resistance genes has been encouraged by a recent FAO/WHO expert panel.

73. Outcrossing. The movement of genes from GM plants into conventional crops or related species in the wild (referred to as “outcrossing”), as well as the mixing of crops derived from conventional seeds with those grown using GM crops, may have an indirect effect on food safety and food security. This risk is real, as was shown when traces of a maize type which was only approved for feed use appeared in maize products for human consumption in the United States of America. Several countries have adopted strategies to reduce mixing, including a clear separation of the fields within which GM crops and conventional crops are grown. Feasibility and methods for post-marketing monitoring of GM food products, for the continued surveillance of the safety of GM food products, are under discussion.

74. How is a risk assessment for the environment performed?

75. Environmental risk assessments cover both the GMO concerned and the potential receiving environment. The assessment process includes evaluation of the characteristics of the GMO and its effect and stability in the environment, combined with ecological characteristics of the environment in which the introduction will take place. The assessment also includes unintended effects which could result from the insertion of the new gene.

76. What are the issues of concern for the environment?

77. Issues of concern include: the capability of the GMO to escape and potentially introduce the engineered genes into wild populations; the persistence of the gene after the GMO has been harvested; the susceptibility of non-target organisms (e.g. insects which are not pests) to the gene product; the stability of the gene; the reduction in the spectrum of other plants including loss of biodiversity; and increased use of chemicals in agriculture. The environmental safety aspects of GM crops vary considerably according to local conditions.

78. Current investigations focus on: the potentially detrimental effect on beneficial insects or a faster induction of resistant insects; the potential generation of new plant pathogens; the potential detrimental consequences for plant biodiversity and wildlife, and a decreased use of the important practice of crop rotation in certain local situations; and the movement of herbicide resistance genes to other plants.

79. Are GM foods safe? Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case-by-case basis and that it is not possible to make general statements on the safety of all GM foods.

80. GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of the consumption of such foods by the general population in the countries where they have been approved. Continuous use of risk assessments based on the Codex principles and, where appropriate, including post market monitoring, should form the basis for evaluating the safety of GM foods.