Food safety and quality
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OECD Unique Identifier details

MON-ØØ81Ø-6
Commodity: Corn / Maize
Traits: Lepidoptera resistance
Australia
Name of product applicant: Monsanto Australia Ltd
Summary of application:
One genetically modified corn line (MON 810) was generated by the transfer of the cry1A(b) gene into the parental line (genotype Hi-II) and confers protection against attack from insects. The protein product is an insecticidal crystal protein, whose toxic effect is specific to Lepidopteran insects, in this case the European Corn Borer.The insect-protected corn plant line is known commercially as Yieldgard corn as it is
protected against attack from Lepidopteran attack, particularly the European Corn Borer. The corn was developed by Monsanto Ltd for cultivation in the United States. Products derived from corn harvested from these plants may have been imported into Australia and New Zealand.
Domestic production of corn in both countries is supplemented by a small amount of
imported corn-based products, largely as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Other products include maize starch which is used by the food industry for the manufacture of dessert mixes and canned foods and cornbased ingredients processed into breakfast cereals, baking products, extruded confectionary and corn chips.
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Date of authorization: 07/12/2000
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment:
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Application A346 - Food produced from insect protected corn line MON 810
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
Useful links
Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
commercial release of genetically modified corn resistant to insects of the Lepidoptera order (Guardian Corn, Event MON810), as well as all the progenies coming from the
transformation event MON180, and its derivatives of crossing of lineages, and non—transgenic populations of corn with lineages bearing event MON810
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Date of authorization: 16/08/2007
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for environmental Risk assessment
Summary of the safety assessment:
Event MON810. Integrated to its genome, Guardian corn that derives from lineage MON810, presents gene cry1Ab, that comes from Bacillus thuringiensis subsp. kurstaki, which codifies protein Cry1Ab with toxic effect over insects of Lepidoptera order (Spodoptera frugiperda, earworm and Meromyza Americana). The transformation process consisted of the bombarding of vegetal material with particles coated with the genetic material of interest, generating the corn lineage MON810 that contains gene cry1Ab of B. thuringiensis (classified as organism of risk class I of biosafety). The expression levels of protein Cry 1AB (also called Bt, from Bacillus thuringiensis) of lineage MON810 were evaluated on young leaves, grains, whole plant and pollen. The results showed the highest levels of expression on leaves (9.35 μg/g of dry weight), followed by the whole plant (4.31 μ/g of dry weight), grains (0.31 μg/g of dry weight) and pollen (0.09 μg/g of dry weight). The protein is toxic only for the mentioned target insects, specifically to lepidopteron (worms) that exclusively have in their intestines specific receptors for this protein. Mammals do not have these receptors, or connection places, and, therefore, human beings, animals, and other organisms that are not target are not affected by protein Bt, including other arthropods and also natural enemies of target-plagues. The protein sequence was compared to data banks of protein with allergenic properties, and no biologically meaningful homology was demonstrated between protein Cry1Ab as a whole and sequences of proteins with these properties. Due to digestibility characteristics of protein Cry1Ab on gastric and intestinal fluids, the probability that it presents allergenic action is extremely low. It is improbable that exogenous DNA may integrate itself to human genome, for DNA molecule is disintegrated during the digestion process, and would hardly stay intact to be used by the human or animal body cells. The introduction of gene cry1Ab did not result on apparent alteration of nutritional importance, for the profiles of the main nutrients were similar to those normally observed in other varieties, or under distinct conditions of cultivation. Thus, the results about chemical and centesimal composition of MON810 corn are in accordance with the Principle of Substantial Equivalence. Due to the smaller infestation by insects in relation to the traditional varieties of corn, there is less growth of associated fungus, micotoxins producers of pathologic importance for human beings and animals, and, consequently, considerably reducing the contamination and the presence of these toxins, contributing to improve the quality and food safety of grains. The possibility of transgenic plant, or progenies coming from the crossing of lineage MON810 with other corn plants, to become weed species is minimum due to biological characteristics of the species, and to the fact that corn does not survive well without human intervention. Corn is an entirely domesticated plant, and needs the men to survive. Since the event introduced into corn does not have relation to the reproduction of the plant, or with its interaction with the environment, it is expected that the transgenic corn Bt have environmental behavior similar to the common corn, having, therefore, no possibility of this corn to become an invasive plant or weed. B. thuringiensis is a soil microorganisms and the exposition of live organisms, and of the environment to this bacteria, or to any element extracted from it, is an event that occurs abundantly in nature, not resulting in meaningful risk for the soil micro biota. Agriculturists, including those that prefer the so- called organic agriculture, have been spreading this bacteria for a long time over plants to avoid lepidopteron from destroying them. Various studies results have shown that corn MON810 does not cause negative impact over the community of non-targeted evaluated organisms. Information indicate that transgenic plants do not fundamentally differ from genotypes of untransformed corn, except for the resistance to insects of Lepidopteron order. The background of ten years of safe use of this transgenic variety in the world points to great accumulation of trustworthy scientific information that indicate that this variety is as safe for the environment, and for human and animal’s health as the hybrid corns varieties that have been being used. Additionally, there is no evidence of adverse reactions to the use of Guardian corn. For these reasons, there are no restrictions to the use of this corn, or of its derivatives for human or animal feeding. CTNBio TECHNICAL OPINION I. GMO Identification Designation of GMO: Guardian Corn, Event MON810 Petitioner: Monsanto do Brasil Ltda. Species: Zea mays – Corn Inserted Characteristics: Resistance to insects of Lepidoptera order Method of characteristic introduction: Bombarding of particles method Proposed Use: Silage and grains Production for human and animal consume of GMO and its derivatives. II. General Information Zea mays L., the corn, is a species that belongs to Maydae tribe that is included in the sub-family Panicoideae, Gramineae family (Poaceae). The genders belonging to Maydae tribe include Zea and Tripsacum in the Western Hemisphere. Corn is a separate species within Zea sub-gender, with chromosome number 2n = 20,21,22,24 (15). The sylvan species closer to corn is teosinte, found in Mexico and in some places in Central America, where it can be crossed with corn cultivated in production fields. The corn produced can also be crossed with the most distant genre Tripsacum. This crossing, however, occurs with great difficulty and results on sterile-male progeny. Corn history is over eight thousand years old in the Americas. Out of all the cultivated plants, it is probably the one that has the greatest genetic variety. Today, there are around 300 races of corn, and within each race, thousands of crops. Corn is nowadays, the cultivated species that reached the highest degree of domestication and only survives in nature when it is cultivated by men(6). The maintenance of this genetic variability has been usually made through individualized storage, in germoplasm banks, with controlled conditions of humidity and temperature. There are many germoplasm banks in Brazil, and in the world. Embrapa has two germoplasm banks, one at Embrapa Genetic Resources and Biotechnology, in Brasília-DF, and another one at Embrapa Corn and Sorghum, in Sete Lagoas-MG. Corn is commercially cultivated in over 100 countries, with a total production estimated in 705 million tons/year. Corn is one of the most important sources of food in the world, and is raw material for the production of a wide range of products. In the productive chain of swine and poultry, approximately 70 to 80% of the corn produced in Brazil is consumed. Brazil is the third biggest corn producer in the world with a production of approximately 35 million tons in 2005, behind only of the United states of America (282 million tons), and China (139 million tons)(19). In Brazil, corn is basically planted in two crops (summer plantation, and small crop), and it is cultivated practically all over the national territory, being 92% of the production in the South (47% of production), Southeast (21% of production) and Center-West (24% of production). In the last years, insects have become plagues that limit the corn culture in Brazil, especially insects of Lepidoptera order (Spodoptera frugiperda, earworm and Meromyza Americana). It is estimated that they may cause damages of up to 34% on the production of corn grains. With the increase of the area cultivated with corn during the so-called “small crop” (three million hectares), closing the cycle of various plagues and diseases, the problema became bigger. In some areas of the Brazilian Center-West, it is necessary dozens of pulverizations with insecticides in only one cycle of cultivation. Brazil is the third biggest consumer of agricultural defensives in the world. Nowadays, we have 142 registered agro toxics for corn, 107 only for worms. There are already many cases of resistance for the constant and indiscriminate use of insecticides in corn culture in Brazil. What’s more, one of the factors that mostly affects agriculturists’ health in Brazil is the use of agricultural defensives, which are responsible for the intoxication of a million people every year. Guardian corn, event MON810, consists of an alternative proposal for the control of worms, plagues of corn culture. It is based on the use of corn hybrids that derive from lineage MON810, genetically modified to be resistant to these worms attack. For this purpose, gene cry1Ab of Bacillus thuringiensis subsp. kurstaki (Bt), lineage HD-1 was inserted. The same lineage was used in commercial formulations of B. thuringiensis of wide use in agriculture. Transgenic corn MON810 – Guardian Corn is already cultivated, or commercialized in 14 countries (Argentina, Australia, Canada, China, European Union, Japan, Korea, Philippines, Mexico, South Africa, Switzerland, Taiwan, Uruguay and The United States of America). The event was developed with the introduction of gene cry1Ab of Bt in one corn lineage, through biobalistics process. The event expresses protein Cry1Ab, responsable for the death of worms during the whole vegetable cycle. This protein is specific for lepidopteron (worms), and does not have toxic effect over dipterous (flies, bees, and others) or coleopterons (beetles, ladybugs and others). The protein produced on Bt corn is identical to the one found in nature, or in formulations for pulverizations available in the market for over 40 years. It is important to highlight that corn varieties containing this protein have been used in many countries in the world, and there is no information that hybrids of corn containing cry genes have caused damage to the environment, or to human or other animal’s health. In Brazil, many releases in the environment of Guardian corn, were conducted after approval by CTNBio in regions that represent the corn culture, including the states of São Paulo, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Goiás, Rio Grande do Sul, Distrito Federal, Santa Catarina and Bahia. III. Description of GMO and Expressed Proteins The corn lineage MON810 was obtained through the genetic transformation, particles acceleration methodology or biobalistics, of plants of hybrid corn HI-II, resulting form the crossing of public lineages of corn A188 and B73, developed in the United States of America by the University of Minnesota, and by the University of the State of Iowa, respectively. According to the company’s information, the genotypes represent around 50% of each material. These plants were transformed into vectors PV-ZMBK07 and PVZMGT10, generating the corn lineage MON810 that contains gene cry1Ab of B. thuringiensis (classified as organism of risk class I of biosafety). B. thuringiensis is a soil bacteria, gram-positive, initially isolated in Japan by Ishiata, and formally described by Berliner in 1915. This microorganism forms crystals of endotoxins, proteins with insecticide action that act before and during the sporulation phase of its life cycle. Nowadays, there are many collections in the world that contain thousands of isolated B. thuringiensis, being many races classified based on their spectrum of action, their crystalline toxins and their genetic similarities. Vector PV-ZMBK07 contains the gene that codifies endotoxin Cry1Ab, and vector PV-ZMGT10 contains genes cp4-epsps and gox. Gene cry 1Ab present in vector PV-ZMBK07 was put under control of transcriptional promoter E35S (around 0.6 kb). An intron of 0.8kb deriving from gene hsp70 of corn was also inserted between the promoter and the gene cry1Ab. This insertion was made in order to increase the levels of transgenic expression. To the reflux of the gene cry1Ab was put the sequence 3’-UTR (transcribed, but not translated) of 0.26 kb of nopaline synthase, which contains the signal of polyadenylation. The sequence of gene cry1Ab is composed by 3468 nucleotides, and codifies one protein of B. thuringiensis sbsp. kurstaki HD-1 (Cry1Ab) of 1156 amino acids. To allow adequate levels of expression in corn, the sequence of gene was modified to adjust the use of códons and proportion A + T. Thus, the proteic sequence did not differ from the one obtained from B. thuringiensis. The molecular characterization was executed to identify the presence of vectors PV-ZMBK07 and PV-ZMGT10 on the genome of transformed corn plants, besides the number of copies integrated to the genome. The molecular characterization of lineage MON810 was made by Southern Blot, indicating the integration of a sole copy of gene cry1Ab with the promoter 35S and the intron of corn hsp70 without any residue of sequences of the vector or of the gene nptll, of resistance to neomycin. Also, it was noticed the absence of genes gox and cp4-epsps of the construction on vector PV-ZMGT10. The absence o additional sequences on lineage MON810 restricts the evaluation of safety to the implications of the presence of gene cry1Ab. The genetic stability of elements present on vector PVZMBK07 was characterized from the execution of crossings, and evaluation of segregation of progenies derived from lineage MON810. The results indicate the occurrence of a sole functional insertion, in accordance with the Mendeliane Genetic. According to information present on the process, gene cry1Ab showed to be stable for seven generations of crossings with one of its recurrent parent (B73), and for six generations of crossings with a nonparental lineage (Mo17). These data were also confirmed from the hybridizations with a probe formed by part of gene cry1Ab. The mechanism of action of toxins Cry have been extensively studied in lepidopteron, dipterous, and coleopterons. On the alkaline pH of insects’ intestines, proteins crystals ingested are dissolved, and the pro-toxins are ctivated by digestive proteinases of insects. The mechanism of action of proteins Cry revealed by Broderick and collaborators(9) indicates that the toxin Cry makes the intestinal epitheliums permeable, allowing bacteria of the digestive treat to contaminate hemolynpha, leading to a septicemia picture and death of the worm. The expression levels of protein cry1Ab on the lineage MON810 were evaluated in young leaves, grains, whole plant and pollen. Materials were collected in six places in the United States of America, and the levels o expression of the protein were evaluated by ELISA and Western blot. The results showed the highest levels of expression on leaves (9.35 μg/g of dry weight), followed by the whole plant (4.31 μg/g of dry weight), grains (0.31 μg/g of dry weight), and pollen (0.09 μg/g of dry weight). Later on, the transfer of the cassette of expression containing the gene cry1Ab for tropical germoplasm of corn was executed. The first introductions of more adapted materials, or materials in phase of adaptation, were made in Brazil in 1998. According to the petitioner, these requests aimed at experimenting lineages derived from MON810 in Brazil and roceed to the introgression of the gene in improvement programs. To confirm the introgression of the cassette of expression on tropical lineages, an experiment of Southern blot was executed, and it identified the presence of the transgene on the sample genotypes. IV. Aspects Related to Human and Animals’ Health The evaluation of safety of foods derived from genetically modified raw material is based on risk analysis, scientific methodology that encompass the phases of evaluation, management and risk communication. On the risk evaluation phase one looks for the qualitative and quantitative characterization of potential adverse effects, having as base the concept of substantial equivalence, for the identification of eventual differences between the new food, and its conventional correspondent. To evaluate safety of genetically modified food raw material, or its equivalence to conventional food, it is recommended that four main elements are analyzed, more specifically: (1) parental variety, that is, the plant that originated the new genetically modified raw material; (2) The transformation process, including the characterization of the construction used, and of the resulting event; (3) the inserted gene product and the potential toxicity and allergenicity, and; (4) the composition of the new variety deriving from the genetic transformation. The group of data of this analysis should allow for the identification and characterization of the potential adverse effects associated to the consume of the new raw-material, subsidizing the phases of management and risk communication. Z. mays is a well characterized species, having solid background of safety for human consume. During the process a considerable volume of information is presented, including the origin, domestication, identity, taxonomy, morphology, genetics hybridization and crossing, that reflect the profound degree of knowledge around this species. Cultures of B. thuringiensis are registered at the National Health Surveillance Agency – ANVISA under diferente formulations for application in 30 kinds of vegetable cultures for food use. They are included on the toxicological classification of group IV, and there is no determined maximum limit of residues and safety interval. In the process, it is mentioned that the sequence of gene cry1ab of B. thuringiensis was modified to provide high expression on corn, without, however, modifying the amino acids sequence. This alteration does not imply on increased risk, due to the variation on the repertoire of common bases to the genetic code of organisms. The transformation process consisted of the bombarding of vegetal material with particles coated with genetic material of interest. Once this is a physical process of DNA molecules transfer, that does not count with intermediation of any biological agent, and is executed with asepsis conditions, it is practically little the chances of having DNA molecules, other than those of the genic construction present on particles, transferred to vegetable cells. Protein Cry1Ab is a á-endotoxin, produced by B. thuringiensis that presents specific activity over the digestive system of some family of insects. For its activity, the protein should be ingested by insects, whose stomach pH is capable of solubilizing protein. Under the proteases action, the protein is transformed on the activated form that is linked to specific receptors of high affinity present in insects and absent in mammals. The protein is only toxic for the mentioned target insects, more specifically to lepidopteron (worms), who have in their intestines, specific receptors for this protein. Mammals do not have such places of linkage, and, therefore, human beings, animals and other untargeted organisms are not affected by protein Bt, including other arthropods and also natural enemies of target-plagues. Studies were conducted to evaluate the toxicity of corn MON810, and of protein Cry1Ab. Quails were fed with grains of corn of lineage MON810 with up to 10% of weight of bran of corn whole grains on the diet, and adverse or toxic effects have not been observed. Sanden and collaborators (37) concluded that corn MON810, added to 12% of fish food, are as safe as non-transgenic varieties, evaluating parameters of the intestinal treat of Atlantic salmon. Studies of food safety for mammals were carried out with the protein expressed in E. coli that turned out to be chemical and functionally equivalent to the one expressed on lineage MON810, as well as in a formulation of microbial plaguecide (DIPEL) containing B. thuringiensis. Studies of acute oral toxicity for rats showed that the level reached, without noted effects, was 4000 mg/Kg of body weight being proposed a DL50 over this value. A recent published study that evaluated the sub-chronic toxicity (90 days) of Guardian corn in rats demonstrated that adding corn MON810 on levels of 11% and 33% to balanced diets did not bring any alterations to animals fed with the genetically modified variety, when compared to the non-modified lineage(24). Shimada and collaborators(39) demonstrated the absence of toxicity of protein Cry1Ab over culture of isolated hepatocites of bovine suggesting that the protein has low acute toxicity for mammal’s cells. Protein Cry1Ab does not present allergenicity characteristics, besides being degraded in the gastrointestinal system of mammals. Data available in literature(41) have indicated normal digestibility for the varieties of transgenic corn released for human consume. Okunuki and collaborators(34) argue that the protein allergenicity, if any, should be meaningless due to the digestibility characteristics of protein Cry1Ab in gastric and intestinal fluids. These authors demonstrate also that after being heated, the degradation is faster, what suggests a smaller concentration of protein in foods based on corn that are heated during the processing. The protein sequence was compared to data banks of proteins with allergenic properties. Meaningful biologically homology was not demonstrated between the complete protein Cry1Ab and sequences of proteins with these known proteins at the time of this process presentation. To check the allergenic potential of proteins extracted from the transgenic corn MON810, and of protein Cry1Ab, Batista and collaborators(7) evaluated two sensitive populations of individuals, through skin tests: children with inhaling allergy, and allergy to foods , and individuals with asthma-rhinitis. Besides, they also evaluated IgE levels in serum of individuals allergic to corn and pure transgenic proteins (Cry1Ab). Authors concluded that the transgenic evaluated regarding the allergenic potential are safe. Similar results were observed by Nakajima and collaborators(31) in patients with allergy to foods. In these patients, no meaningful levels of specific IgE against Cry1Ab in serum were found. The analysis of chemical composition of the variety obtained through transgene, mainly the levels of its nutrients and of eventual toxic compositions naturally present, aims at guaranteeing that this new variety is as nutritive and safe as its conventional equivalent. Thus, it serves to confirm that intentional effects of modification did not compromise its safety, nor resulted in non-intended effects. International data presented on the process include the centesimal composition, profile of amino acids and fatty acids of genetically modified variety, and of cultivated parental varieties, under the same conditions, in the United States (1994), Italy, France (1995). In general, for all the analyzed parameters, there was no meaningful difference between the genetically modified variety, and its respective conventional counter-part, or the differences were within the variety normally noted in corn. Thus, it is possible to consider that the introduction of gene cry1Ab has not resulted on apparent alteration of nutritional importance, for the profiles of the main nutrients were similar to those normally conserved in other varieties, or under different conditions of cultivation. In Brazil, there were analysis of centesimal composition of two hybrids derived from the lineage MON810, C806-guardian, cultivated in the municipalities of Campo Novo dos Parecis (MT), Uberaba (MG), and Pirassununga (SP) on the 1998-1999 crop. Similarly to what was observed for corn samples of lineage MON810 cultivated abroad, there was no meaningful difference in relation to the conventional variety, or the differences were within the variability normally found in corn. Data suggest that, also on plants cultivated in Brazil, the introduction of gene cry1Ab has not resulted on apparent nutritional alteration. Thus, results about chemical and centesimal composition of corn 810 are in accordance with the Principle of Substantial Equivalence that affirms that, if food is modified by any technique and has the same chemical and physical composition, texture, nutritional value, and does not present toxic substance different from the original food, these foods are substantially equivalent, and, therefore, should not be differentiated or segregated. According to Codex Alimentarius, the Principle of Substantial Equivalence is a key element on the process of innocuousness evaluation of new food in relation to its conventional homologous. It is relevant to consider that the protection given to grains by toxin Bt against damages of worms on the spike drastically reduces the incidence of rancid grains. The presence of rancid grains is associated to production of micotoxins, and it is a serious problem on corn. Thus, the smaller observed infestation by insects brings as consequence a smaller growth of fungus that produce micotoxins of pathologic importance for humans and animals, considerably reducing contamination, and consequently, the presence of such toxins (22,23,28,35,43,44), contributing to improve the quality and level of food safety of grains. V. Environmental Aspects Corn is a monoic plant: a sole individual contains male and female flowers located separately. Corn plants are plants of crossed fecundation, and widely pollinated with the help of the wind, insects, gravity and others. The introduction of genic elements previously described has not altered the reproductive characteristics of the plant. Therefore, the same chances of crossed fecundation that occur between hybrids and conventional corn lineages - not genetically modified - will occur between plants of event MON810 and other corn plants. Corn genic flow may occur through pollen transfer and sedes dispersion. Seeds dispersion is easily controlled, once corn domestication eliminated the ancient mechanisms of seeds dispersion, and pollen movement is the only effective mean of corn plants genes escape. Studies about corn pollen dispersion have been conducted, and some of them show that corn pollen may travel long istances. However, most pollen that is released is deposited near the culture, with very low translocation rate outside the source culture. The predominant pollination agent for corn is the wind, and the distance that viable pollen may travel depends on wind patterns, humidity and temperature. Luna and collaborators have evaluated the distance of isolation and control of pollen, and have demonstrated that crossed pollination occurs in a maximum distance of 200m, and no crossed pollination happened in the same distances, or over 300 meters in relation to pollen sources, in non detasseling condition. The results indicate that the viability of pollen is kept for 2h, and that crossed pollination was not observed in 300 meters distances from the pollen source. Comparing the concentrations at 1 m of source culture, under low to moderate winds, it was estimated that approximately 2% of pollen is annotated at 60m, 1.1% at 200m and 0.75-0.5% at 500m of distance. At 10m from a field, in average, the number of pollen grains per área unit is ten times smaller than the one observed at 1m from the border. Therefore, if the established distances of separation developed for corn seed production are observed, it is expected that the pollen transfer to the adjacent varieties is minimized, and the presence of any genetic materials resistant to insects is improbable. Corn is an allogamous and annual plant, the predominant pollination agent for corn is the wind and the distance that pollen may travel depends on wind patterns, humidity and temperature. Corn pollen is dispersed freely around the area cultivated with this gramineae, and it may reach the stigma-style of the same genotype, or of different genotypes, and in adequate conditions, it starts its germination, originating the pollinic tube that promotes fecundation of the ovule within the average period of 24 hours. The possibility of the transgenic plant to become a weed, as well as the lineage crossing MON810 with other corn plants, to originate a weed is very low, due to the biological characteristics of the species, and to the fact that corn does not survive without men intervention, result of the selection made during its evolution. Corn is the species that reached the highest degree of domestication among cultivated plants, having lost its survival characteristics in nature, such as, for example, degrana elimination. Thus, corn is a plant that is incapable of surviving in natural conditions, when not technically assisted. So, it is expected that transgenic Bt corn has an environmental behavior similar to the common corn, therefore, there is no possibility that corn is transformed into an invasive plant or weed. The possibility of gene cry1Ab of the transgenic plant pass to other organisms, as for example, soil microorganisms is practically null (32, 40). Once B. thuringiensis is a soil microorganisms, the expositions of live organisms, and of the environment to this bacteria, or to any elemento extracted from it, is an event that occurs abundantly in nature, not resulting in meaningful risk for the soil micro biota. Another remote possibility is the transfer of exogenous DNA to the human being that would consume corn MON810. Depending on the composition of the ingested food, the amount of DNA ingested by a person varies between 0.1 and 1.0 per day. The gene inserted into corn MON810 represents a quantity 20,000 times smaller than this. Besides, DNA molecule is disintegrated during the digestion impeding it to be absorbed as a whole by intestine cells, likewise, men and animal do not absorb DNA of billions of bacteria that live in the intestine, or of any non-transgenic food. Additionally, commercial formulations of B. thuringiensis containing these proteins have been being used in Brazil and in other countries for the control of some agricultural plagues for 40 years. Due to its insecticides properties, spray products based on Bt are the most efficacious commercial bio-insecticides used for protecting crops, and forests, and they start to substitute the measures of conventional control that present practical limitations(14). Nowadays, bio-pesticides based on toxin Bt represent around 90% of the world market of bio-pesticides, being widely used as an alternative to chemical insecticides in terms of safety to untargeted organisms, and when there is the development of resistance to chemical insecticides. Cry1Ab protein safety was tested for the following organisms: bees (Apis melifera L.) in larvae and adults, benefic pollinizer; crisopideo (Cryperla carnea) benefic predator; a hymenoptera (Brachymeria intermedia), parasitoid benefic insect of the domestic fly; ladybug (Hippodamia convergens) benefic predator insect; worms (Esenia fétida); micro-crustaceous of aquatic environments, Daphnia magna. Field studies carried out in Brazil, about insect populations present in transgenic corn plantations derived from the lineage MON810, showed that the presence of natural enemies, and of non-target insects in these fields is similar. Field essays made for the evaluation of insects population dynamics, such as beetles, ladybugs (Coleopteran), syrphidae (Dipteral), bugs (Hemiptera) have not demonstrated meaningful impacts on entomofauna of the studied regions. Corn MON810 has not present effect over the population dynamics of the predominant species of spiders and benefic insects of different trophic guilds either, including nontarget plagues and benefic insects (Carabidae, Coccinellidae, Chrysopidae, Hemerobiidae, Syrphidae, Tachinidae and Apidae). The bees’ population, A. mellifera, was bigger in the evaluated areas. This result may be explained this way: (1) protein Cry1Ab does not act in the digestive system of the bees, for it is specific only for some lepidopteron species; (2) bees freely feed from the pollen for the smaller use of insecticides on corn MON810 plantations. Two doctorate theses analyze the possible impacts caused by corn MON810 over the different taxonomic groups that represent biodiversity of Brazilian agro-system where corn plantation is carried out. The main conclusion was that corn MON810 does not have negative impact over the evaluated insects’ community. Data available in literature corroborate to the results found, and are also evidence that among the advantages of use of cry gene, in relation to other control methods of lepidopteron, is the absence of negative effects in non-target insects, mammals and human beings, the high specificity and efficiency against target-insects, the environmental degradability, and the safety of manipulation and use. One should highlight that any insects control measure that allow for the reduction on the use of chemical defensives should be considered as a priority under the point of view of environmental and nutritional safety. VI. Restriction to the use of GMO and its derivatives: Technical opinions regarding the agronomic performance came to the conclusion that there is equivalence between transgenic and conventional plants. Thus, information indicates that transgenic plants do not fundamentally differ from non transformed corn genotypes, except for resistance to insects of Lepidoptera order. Additionally, there is no evidence of adverse reactions to the use of Guardian corn. Thus, there is no restriction to the use of this corn, or of its derivatives to human or animal feeding. The vertical gene flow for local varieties (called creoles corn) of open pollination is possible, and presents the same risk caused by commercial genotypes available in the market (80% of planted conventional corn in Brazil comes from commercial seeds that went through a genetic improvement process). The coexistence between conventional corns cultivation (improved or creoles), and transgenic cultivations of corns is possible from the agronomic point of view
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular traditional Methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Comission
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Authorization expiration date: Not Aplicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Canada
Name of product applicant: Monsanto Canada Inc.
Summary of application:
MON810 offers the Canadian grower protection against the loss of yield due to infestation with the European Corn Borer (ECB), a damaging lepidopteran insect pest in Canadian corn production.

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Date of authorization: 17/02/1997
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment:
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Novel Foods Decision
Novel Feeds Decision
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Authorization expiration date:
E-mail:
luc.bourbonniere@hc-sc.gc.ca
Organization/agency name (Full name):
Health Canada
Contact person name:
Luc Bourbonniere
Website:
Physical full address:
251 Sir Frederick Banting Driveway, Tunney's Pasture, PL 2204A1
Phone number:
613-957-1405
Fax number:
613-952-6400
Country introduction:
Federal responsibility for the regulations dealing with foods sold in Canada, including novel foods, is shared by Health Canada and the Canadian Food Inspection Agency (CFIA). Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods and developing labelling policies related to health and nutrition. The CFIA develops standards related to the packaging, labelling and advertising of foods, and handles all inspection and enforcement duties. The CFIA also has responsibility for the regulation of seeds, veterinary biologics, fertilizers and livestock feeds. More specifically, CFIA is responsible for the regulations and guidelines dealing with cultivating plants with novel traits and dealing with livestock feeds and for conducting the respective safety assessments, whereas Health Canada is responsible for the regulations and guidelines pertaining to novel foods and for conducting safety assessments of novel foods. The mechanism by which Health Canada controls the sale of novel foods in Canada is the mandatory pre-market notification requirement as set out in Division 28 of Part B of the Food and Drug Regulations (see Figure 1). Manufacturers or importers are required under these regulations to submit information to Health Canada regarding the product in question so that a determination can be made with respect to the product's safety prior to sale. The safety criteria for the assessment of novel foods outlined in the current document were derived from internationally established scientific principles and guidelines developed through the work of the Organization for Economic Cooperation and Development (OECD), Food and Agriculture Organisation (FAO), World Health Organisation (WHO) and the Codex Alimentarius Commission. These guidelines provide for both the rigour and the flexibility required to determine the need for notification and to conduct the safety assessment of the broad range of food products being developed. This flexibility is needed to allow novel foods and food products to be assessed on a case-by-case basis and to take into consideration future scientific advances.
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Stacked events:
Food: Consistent with the definition of "novel food" in Division 28 of the Food and Drug Regulations, the progeny derived from the conventional breeding of approved genetically modified plants (one or both parents are genetically modified) would not be classified as a novel food unless some form of novelty was introduced into such progeny as a result of the cross, hence triggering the requirement for pre-market notification under Division 28. For example, notification may be required for modifications observed in the progeny that result in a change of existing characteristics of the plant that places those characteristics outside of the accepted range, or, that introduce new characteristics not previously observed in that plant (e.g. a major change has occurred in the expression levels of traits when stacked). In addition, the use of a wild species (interspecific cross) not having a history of safe use in the food supply in the development of a new plant line may also require notification to Health Canada. However, molecular stacks are considered new events and are considered to be notifiable as per Division 28.

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Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Luc Bourbonniere, Section Head Novel Foods
China
Name of product applicant: Monsanto Company
Summary of application:

Genetically modified organism: MON-ØØ81Ø-6 (MON810)  line of maize (Zea mays L.); Exogenous gene: Cry1Ab, derived from Bacillus thuringiensis;  Trait: Resistance to European corn borer (Ostrinia nubilalis); Transformation methods: Microparticle bombardment of plant cells or tissue; Safety level: Ⅰ

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Date of authorization: 20/02/2004
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment:
Please see decision document uploaded
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Chinese Agriculture Department Announcement No. 2122-16-2014: Detection of genetically modified plants and derived products Qualitative PCR method for insect-resisteant maize MON810 and its derivates
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Authority concern of GMO
Ministry of Agriculture of China
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Authorization expiration date: 20/2/2007
E-mail:
fuzhongwen@agri.gov.cn
Organization/agency name (Full name):
Development Center for Science and Technology, Ministry of Agriculture
Contact person name:
Fu Zhongwen
Website:
Physical full address:
Room 717, Nongfeng Building, No.96 Dong San Huan Nan Lu, Chaoyang District, Beijing, 100122, P. R. China
Phone number:
+86-10-59199389
Fax number:
+86-10-59199391
Country introduction:
Regulations on Safety of Agricultural Genetically Modified Organisms (hereafter referred to as the Regulations)was promulgated by Decree No. 304 of the State Council of the People’s Republic of China on May 23, 2001. Implementation Regulations on Safety Assessment of Agricultural Genetically Modified Organisms, Implementation Regulations on the Safety of Import of Agricultural Genetically Modified Organisms and Implementation Regulations on Labeling of Agricultural Genetically Modified Organisms are formulated by Ministry of Agriculture on January 5, 2002 in accordance with the Regulations. The State Council establishes a system of joint ministry conference for the safety administration of agricultural GMOs. The joint ministry conference for the safety administration of agricultural GMOs shall be composed of officials from relevant departments of agriculture, science and technology, environment protection, public health, foreign trade and economic cooperation, inspection and quarantine, and be responsible for the decision-making and coordination of major issues with respect to the safety administration of agricultural GMOs. According to Article 9 of the Regulations, a national biosafety committee (NBC) shall be established and in charge of safety assessment of agricultural GMOs. The NBC shall be composed of experts who are engaged in biological research, production, processing, inspection and quarantine with respect to agricultural GMOs, as well as experts in the fields of public health and environmental protection. The office term of the NBC shall be three years. Ministry of Agriculture is responsible for the nationwide supervision and administration of the safety of agricultural GMOs. The Ministry of Agriculture sets up an office for biosafety administration of agricultural GMOs(OBA), which will be in charge of the administration of the safety assessment of agricultural GMOs. OBA is Affiliated to the Department of Science, Technology and Education.
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Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
office for biosafety administration of agricultural GMOs(OBA), the Department of Science, Technology and Education,MOA, P. R. China Tel:+86-10-59193059, Fax:+86-10-59193072, E-mail: gmo@agri.gov.cn
Malaysia
Name of product applicant: Monsanto
Summary of application:
Please refer to uploaded document.
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Date of authorization: 19/09/2008
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Malaysia Biosafety Clearing House
CBD Biosafety Clearing House
Summary of the safety assessment:
Please refer to uploaded document.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
biosafety@nre.gov.my
Organization/agency name (Full name):
Department of Biosafety Malaysia
Contact person name:
Dr. Anita Anthonysamy
Website:
Physical full address:
Dept of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya
Phone number:
+60388861153
Fax number:
+60388904935
Country introduction:
GM food safety assessment is a requirement by law under the Biosafety Act 2007 in Malaysia. The National Biosafety Board reviews and makes decisions on events based on a scientific/technical risk assessment, policy considerations as well as public input. The decisions and its related documents made are publicly available through the Malaysian Department of Biosafety Website and the Convention of Biological Diversity Biosafety Clearing House.
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Malaysian Department of Biosafety Level 1, Podium 2, Wisma Sumber Asli No. 25, Persiaran Perdana, Precinct 4 Putrajaya, Federal Territory Malaysia, 62574. Phone: +603 8886 1746 / 1579. Fax: +603-8889 5604 Email: biosafety@nre.gov.my. Url: www. biosafety.nre.gov.my
Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
Monsanto Philippines, Inc has developed a corn line resistant to the Asiatic corn borer (ACB), a periodic pest of corn. This corn line, designated Yieldgard® (referred to as MON810 in this document), has been transformed using micro projectile bombardment or particle acceleration, to produce an insecticidal protein, from Bacillus thuringiensis (sub species kurstaki),active against lepidopteran corn pest, asiatic corn borer (ACB). This corn line was developed to provide a method to control yield losses from insect feeding damage caused by the larval stages of corn borer, without the use of conventional pesticides.
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Date of authorization: 03/12/2012
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Monsanto Philippines Inc., submitted an application to the Bureau of Plant Industry (BPI) requesting for biosafety permit under AO#8 for corn MON810 which has been genetically modified for insect resistance (corn borer). Corn MON 810 has been evaluated according to BPI’s safety assessment by concerned agencies of the Department of Agriculture: [Bureau of Animal Industry (BAI), Bureau of Plant Industry (BPI), Bureau of Agriculture Fisheries and Product Standards (BAFPS) and Fertilizer and Pesticide Authority (FPA)], and a Scientific Technical Review Panel (STRP). The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological issues and nutritional issues as well as the environmental issues associated with the modified corn. The petitioner/applicant published the said application in two widely circulated newspapers for public comment/review. BPI received positive comments on the petition supporting the cultivation of Corn MON 810 during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
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Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004